SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
Annual Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
For the Fiscal Year Ended
December 31, 2009
Commission File No. 000-51290
EpiCept Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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52-1841431 |
(State or other jurisdiction of
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(IRS Employer Identification No.) |
incorporation or organization) |
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777 Old Saw Mill River Road
Tarrytown, NY 10591
(Address of principal executive offices) (zip code)
Registrants telephone number, including area code: (914) 606-3500
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, par value $.0001 per share
(Title of Class)
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of Class)
Indicate by check mark whether the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes o No þ.
Indicate by check mark whether the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Exchange Act. Yes o No þ.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o.
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes
o No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendments to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer or a smaller reporting company. See definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes
o No
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As of June 30, 2009, the last business day of the registrants most recently completed second
fiscal quarter, the aggregate market value of shares of common stock held by non-affiliates was
$101,370,124.
As of March 5, 2010, the registrant had 44,170,984 shares of its common stock, par value
$.0001 per share, outstanding.
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements that are subject to risks and
uncertainties. All statements other than statements of historical fact included in this Form 10-K
are forward-looking statements. Forward-looking statements give our current expectations and
projections relating to our financial condition, results of operations, plans, objectives, future
performance and business. You can identify forward-looking statements by the fact that they do not
relate strictly to historical or current facts. These statements may include words such as
anticipate, estimate, expect, project, plan, intend, believe, may, should, can
have, likely and other words and terms of similar meaning in connection with any discussion of
the timing or nature of future operating or financial performance or other events.
These forward-looking statements are based on assumptions that we have made in light of our
industry experience and on our perceptions of historical trends, current conditions, expected
future developments and other factors we believe are appropriate under the circumstances. As you
read and consider this Form 10-K, you should understand that these statements are not guarantees of
performance or results. They involve risks, uncertainties (some of which are beyond our control)
and assumptions. Although we believe that these forward-looking statements are based on reasonable
assumptions, you should be aware that many factors could affect our actual financial results and
cause them to differ materially from those anticipated in the forward-looking statements. These
factors include, among others:
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the risk that Ceplene® will not receive regulatory approval or marketing
authorization in the United States or Canada; |
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the risk that Ceplene® will not be launched or achieve significant commercial
success; |
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the risk that Ceplene® will not be reimbursed or receive an acceptable price
for reimbursement in certain countries; |
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the risk that any required post-approval clinical studies for Ceplene® will
not be successful; |
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the risk that we will not be able to maintain our final regulatory approval or marketing
authorization for Ceplene®; |
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the risks associated with the adequacy of our existing cash resources and our ability to
continue as a going concern; |
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the risks associated with our ability to continue to meet our obligations under our
existing debt agreements; |
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the risk that Myriads development of Azixa will not be successful; |
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the risk that Azixa will not receive regulatory approval or achieve significant
commercial success; |
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the risk that we will not receive any significant payments under our agreement with
Myriad; |
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the risk that the development of our other apoptosis product candidates will not be
successful; |
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the risk that clinical trials for EpiCeptTM NP-1 or crinobulin will not be
successful; |
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the risk that EpiCeptTM NP-1 or crinobulin will not receive regulatory
approval or achieve significant commercial success; |
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the risk that we will not be able to find a partner to help conduct the Phase III trials
for EpiCeptTM NP-1 on attractive terms, a timely basis or at all; |
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the risk that our other product candidates that appeared promising in early research and
clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage
clinical trials; |
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the risk that we will not obtain approval to market any of our product candidates;
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the risks associated with dependence upon key personnel; |
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the risks associated with reliance on collaborative partners and others for further
clinical trials, development, manufacturing and commercialization of our product candidates; |
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the cost, delays and uncertainties associated with our scientific research, product
development, clinical trials and regulatory approval process; |
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our history of operating losses since our inception; |
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the highly competitive nature of our business; |
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risks associated with litigation; |
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risks associated with our ability to protect our intellectual property; and |
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the other factors described under Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations. |
There may be other factors that may cause our actual results to differ materially from the
forward-looking statements. Because of these factors, we caution that you should not place undue
reliance on any of our forward-looking statements. Further, any forward-looking statement speaks
only as of the date on which it is made. New risks and uncertainties arise from time to time, and
it is impossible for us to predict those events or how they may affect us. Except as required by
law, we have no duty to, and do not intend to, update or revise the forward-looking statements in
this Form 10-K after the date of this Form 10-K. This Form 10-K also contains market data related
to our business and industry. This market data includes projections that are based on a number of
assumptions. If these assumptions turn out to be incorrect, actual results may differ from the
projections based on these assumptions. As a result, our markets may not grow at the rates
projected by these data, or at all. The failure of these markets to grow at these projected rates
may have a material adverse effect on our business, financial condition, results of operations and
the market price of our common stock. We do not undertake to discuss matters relating to our
ongoing clinical trials or our regulatory
strategies beyond those which have already been made public or discussed herein. As used herein,
references to we, us, our, EpiCept or the Company refer to EpiCept Corporation and its
subsidiaries. References in this Form 10-K to the FDA means the U.S. Food and Drug
Administration.
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ITEM 1. BUSINESS
We are a specialty pharmaceutical company focused on the clinical development and
commercialization of pharmaceutical products for the treatment of cancer and pain. We focus our
clinical development efforts on innovative cancer therapies and topically delivered analgesics
targeting peripheral nerve receptors. Our lead product is Ceplene®, which when used
concomitantly with low-dose interleukin-2 is intended as remission maintenance therapy in the
treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete
remission. In October 2008, the European Commission issued a formal marketing authorization for
Ceplene®
in the European Union, or EU. In November 2009, Health Canada accepted for
review a New Drug Submission, or NDS, for Ceplene® for the treatment of AML in Canada.
We are continuing our preparation of a New Drug Application, or NDA, filing with the United States
Food and Drug Administration, or FDA for Ceplene® in the same indication. In addition
to Ceplene®, we have two oncology compounds and a pain product candidate for the
treatment of peripheral neuropathies in clinical development. We believe this portfolio of
oncology and pain management product candidates lessens our reliance on the success of any single
product or product candidate.
Our cancer portfolio includes crinobulin, a novel small molecule vascular disruption agent, or
VDA, and apoptosis inducer for the treatment of patients with solid tumors. We have completed our
first Phase I clinical trial for crinobulin. AzixaTM, an apoptosis inducer with VDA
activity licensed by us to Myriad Genetics Inc., or Myriad, as part of an exclusive, worldwide
development and commercialization agreement, is currently in Phase II clinical trials in patients
with primary glioblastoma, melanoma that has metastasized to the brain and non-small-cell lung
cancer that has spread to the brain.
Our late-stage pain product candidate, EpiCeptTM NP-1 cream, which we refer to as
NP-1, is a prescription topical analgesic cream designed to provide effective long-term relief of
pain associated with peripheral neuropathies. In January 2009, we concluded a Phase II clinical
trial of NP-1 in which we studied its safety and efficacy in patients suffering from post-herpetic
neuralgia, or PHN, compared to gabapentin and placebo. This trial met its primary endpoints. In
February 2008, we concluded a Phase II clinical study of NP-1 in patients suffering from diabetic
peripheral neuropathy, or DPN. Both studies support the advancement of NP-1 into a
registration-sized trial. NP-1 utilizes a proprietary formulation to administer FDA approved pain
management therapeutics, or analgesics, directly on the skins surface at or near the site of the
pain, targeting pain that is influenced, or mediated, by nerve receptors located just beneath the
skins surface.
Product Portfolio
The following chart illustrates the depth of our product pipeline:
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Cancer
Cancer is the second leading cause of death in the United States. Half of all men and one
third of all women in the United States will develop cancer during their lifetimes. Today, millions
of people are living with cancer or have had cancer. Although there are many kinds of cancer, they
are all caused by the out-of-control growth of abnormal cells. Normal body cells grow, divide, and
die in an orderly fashion. During the early years of a persons life, normal cells divide more
rapidly until the person becomes an adult. After that, cells in most parts of the body divide only
to replace worn-out or dying cells and to repair injuries. Because cancer cells continue to grow
and divide, they are different from normal cells. Instead of dying, they outlive normal cells and
continue to form new abnormal cells.
Cancer usually forms as a tumor. However, some cancers, like leukemia, do not form tumors.
Instead, these cancer cells involve the blood and blood-forming organs and circulate through other
tissues where they grow. Often, cancer cells travel to other parts of the body where they begin to
grow and replace normal tissue. Different types of cancer can behave very differently. For example,
lung cancer and breast cancer are very different diseases. They grow at different rates and respond
to different treatments. That is why people with cancer need treatment that is aimed at their
particular kind of cancer. The risk of developing most types of cancer can be reduced by changes in
a persons lifestyle, for example, by quitting smoking and following a better diet. The sooner a
cancer is found and treatment begins, the better are the chances for long term survival.
Ceplene®
AML is the most deadly and most common type of acute leukemia in adults. There are
approximately 40,000 AML patients in the EU, with 16,000 new cases occurring each year.
Additionally, there are approximately 13,000 new cases of AML and 9,000 deaths caused by this
cancer each year in the United States. Once diagnosed with AML, patients typically receive
induction and consolidation chemotherapy, with the majority achieving complete remission. However,
about 70-80% of patients who achieve first complete remission will relapse, with the median time in
remission before relapse with current treatments being only 12 months. Less than 15% of relapsed
patients survive long-term.
Ceplene® ( histamine dihydrochloride) is our proprietary product for the remission
maintenance and prevention of relapse in adult patients with AML in first remission. Ceplene®
is to be administered in conjunction with low-dose IL-2 and is designed to protect
lymphocytes responsible for immune-mediated destruction of residual leukemic cells.
Ceplene®reduces the formation of oxygen radicals from phagocytes, inhibiting
nicotinamide adenine dinucleotide phosphate-oxidase, or NADPH oxidase, and protecting
IL-2-activated Natural Killer cells, or NK-cells, and Thymus cells, or T-cells. These two kinds of
cells, NK-cells and T-cells, possess an ability to kill and support the killing of cancer cells and
virally infected cells.
In October 2008, we received a full marketing authorization from the European Commission, or
EU, for Ceplene®. The approval allows Ceplene® to be marketed in the 27
member states of the EU, as well as in Iceland, Liechtenstein and Norway. The approval by the
European Commission is based, in part, on the results of the single pivotal 320-patient Phase III
trial for Ceplene® in conjunction with low dose IL-2. The primary result of this trial
was that treatment with Ceplene/IL-2 significantly reduced the occurrence of relapse among AML
patients in complete remission. The improvement of long-term leukemia-free survival in patients
receiving Ceplene/IL-2 exceeded 50%. Moreover, Ceplene® was well tolerated in this
patient population and conferred an acceptable risk benefit profile for AML patients.
Ceplene was designated as an orphan medicinal product in the EU in April 2005 for the
treatment of AML. As a result of its designation as an Orphan Medical Product, we have been
granted 10 years of market exclusivity in the EU from Ceplenes approval date. As part of
receiving marketing authorization under Exceptional Circumstances for Ceplene®, we are
required to perform two post-approval clinical studies that have now been combined into a single
clinical study. The first part of the study will seek to further elucidate the clinical
pharmacology of Ceplene® by assessing certain immune biomarkers in AML patients in first
remission. The second part of the study will assess the effect of Ceplene/IL-2 on the development
of minimal residual disease in the same patient population.
In January 2010, we entered into an exclusive commercialization agreement for
Ceplene® with Meda AB, a leading international specialty pharmaceutical company based in
Stockholm, Sweden. Under the terms of the agreement, we granted Meda the right to market
Ceplene® in Europe and several other countries including Japan, China, and Australia.
We received a $3 million fee on signing and will receive an additional $2 million upon the first
commercial launch of Ceplene in a major European market. We will also receive other milestone
payments and an escalating double digit percent royalty on net sales in the covered territories.
Additionally, we will be responsible for Ceplenes commercial supply.
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We have also advanced our efforts to gain approval for Ceplene® as a remission
maintenance treatment for AML patients in North America. In November 2009, Health Canada accepted
for review a New Drug Submission, or NDS, for Ceplene® for the treatment of AML in
Canada. A decision from Health Canada is expected in 2010. We are preparing a NDA filing for
Ceplene® with the FDA for the treatment of AML in the United States later this year.
Crinobulin
Crinobulin is a novel small molecule vascular disruption agent, or VDA, and apoptosis inducer
for the treatment of patients with solid tumors. Crinobulin has shown promising vascular targeting
activity with potent anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule
has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell
lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts
demonstrated crinobulin inhibits growth of established tumors of a number of different cancer
types. In preclinical tumored animal models, combination therapy has demonstrated synergistic
activity.
In November 2004, two publications appeared in Molecular Cancer Therapeutics discussing
crinobulin, a journal of the American Association of Cancer Research ( Discovery and mechanism of
action of a novel series of apoptosis inducers with potential vascular targeting activity,
Kasibhatla, S., Gourdeau, H., Meerovitch, K., Drewe, J., Reddy, S., Qiu, L., Zhang, H., Bergeron,
F., Bouffard, D., Yang, Q., Herich, J., Lamothe, S., Cai, S. X., Tseng, B., Mol. Cancer Ther. 2004
vol. 3 pp. 1365-1374; and Antivascular and antitumor evaluation of
2-amino-4-(3-bromo-4,5-dimethoxy-phenyl)-3-cyano-4H-chromenes, a novel series of anticancer
agents, Henriette Gourdeau, Lorraine Leblond, Bettina Hamelin, Clemence Desputeau, Kelly Dong,
Irenej Kianicka, Dominique Custeau, Chantal Boudreau, Lilianne Geerts, Sui-Xiong Cai, John Drewe,
Denis Labrecque, Shailaja Kasibhatla, and Ben Tseng, Mol. Cancer Ther. 2004 vol. 3 pp.1375-1384).
The manuscripts characterize crinobulin as a potent caspase activator demonstrating vascular
targeting activity and potent antitumor activity in pre-clinical in vitro and in vivo studies.
Crinobulin appeared highly effective in mouse tumor models, producing tumor necrosis at doses that
correspond to only 25% of the maximum tolerated dose, or MTD. Moreover, in combination treatment,
crinobulin significantly enhanced the antitumor activity of cisplatin/taxane, resulting in
tumor-free animals.
In October 2007, we completed a Phase I clinical trial for crinobulin. We successfully
identified the maximum tolerated dose, or MTD, of crinobulin in the Phase I study. The MTD was
below the dose which produced the expected toxicity based on preclinical studies at higher doses.
Crinobulin was administered as a single agent in increasing doses to small cohorts of patients with
advanced solid tumors. A total of seventeen patients were enrolled in the study. The drug was
tested in a variety of cancer types including melanoma, prostate, lung, breast, colon, and
pancreatic cancers. The study, which was initiated in December 2006, was conducted at three cancer
centers in the United States. In addition to determining crinobulins MTD, the primary objective
of the study was to determine the pharmacokinetic profile of the drug. In 2008, we enrolled an
additional sixteen patients into the study, lengthening the infusion period of the drug in order to
increase the MTD. The studies helped characterize the pharmacodynamic effects on tumor blood flow
and identified early signs of objective anti-tumor response as measured by computed axial
tomography, or CT scans, magnetic resonance imaging, or MRI, or positron emission tomography, or
PET scan, in advanced cancer patients with well vascularized solid tumors. A Phase Ib study of
crinobulin in combination with other chemotherapeutic agents is planned to commence in 2010.
Azixaä
(MPC6827)
AzixaTM is a compound discovered internally and licensed to Myriad Genetics for
clinical development. AzixaTM demonstrated a broad range of anti-tumor activities
against many tumor types in various animal models as well as activity against different types of
multi-drug resistant cell lines. The Phase I clinical testing was conducted by Myriad, on patients
with solid tumors with a particular focus on brain cancers or brain metastases due to the
pharmacologic properties of AzixaTM in pre-clinical animal studies that indicated higher
drug levels in the brain than in the blood. Myriad reported in the third quarter of 2006 that a MTD
had been reached for AzixaTM and that they had seen evidence of tumor regression at
doses less than the MTD in some patients. In March 2007, Myriad initiated two Phase II
registration-sized clinical trials for AzixaTM in patients with primary brain cancer and
in patients with melanoma that has spread to the brain. The trials are designed to assess the
safety profile of AzixaTM and the extent to which it can improve the overall survival of
these patients. In November 2009 Myriad announced interim results of its Phase II trial of
AzixaTM in melanoma metastases in which ten of the 22 patients treated achieved stable
disease and two patients achieved confirmed partial responses. The median progression-free
survival was 2.8 months. AzixaTM has received orphan drug status in the United States
for the treatment of glioblastoma.
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Peripheral Neuropathy
Peripheral neuropathy is a medical condition caused by damage to the nerves in the peripheral
nervous system. The peripheral nervous system includes nerves that run from the brain and spinal
cord to the rest of the body. A 2006 study conducted by Business Insight stated that peripheral
neuropathy affects over 15 million people in the United States and is associated with conditions
that injure peripheral nerves, including herpes zoster, or shingles, diabetes, HIV/AIDS and other
diseases. It can also be caused by trauma or may result from surgical procedures. Peripheral
neuropathy is usually first felt as tingling and numbness in the hands and feet. Symptoms can be
experienced in many ways, including burning, shooting pain, throbbing or aching. Peripheral
neuropathy can cause intense chronic pain that, in many instances, is debilitating.
Post-herpetic neuralgia, or PHN, is one type of peripheral neuropathic pain associated with
herpes zoster, or shingles, which exists after the rash has healed. According to Datamonitor, PHN
affects over 100,000 people in the United States each year. PHN causes pain on and around the area
of skin that was affected by the shingles rash. Most people with PHN describe their pain as mild
or moderate. However, the pain can be severe in some cases. PHN pain is usually a constant,
burning or gnawing pain but can be an intermittent sharp or stabbing pain. Current treatments for
PHN have limited effectiveness, particularly in severe cases and can cause significant adverse side
effects. One of the initial indications for our NP-1 product candidate is for the treatment of
peripheral neuropathy in PHN patients.
Painful diabetic peripheral neuropathy, or DPN, is common in patients with long-standing Type
1(juvenile) and Type 2 (adult onset) diabetes mellitus. An estimated 18.2 million people have
diabetes mellitus in the United States. The prevalence of neuropathy approaches 50% in those with
diabetes mellitus for greater than 25 years. Specifically, the lifetime incidence of DPN is 11.6%
and 32.1% for Type 1 and 2 diabetes, respectively. Common symptoms of DPN are sharp, stabbing,
burning pain, or allodynia, which is pain to light touch, with numbness and tingling of the feet
and sometimes the hands.
Various drugs are currently used in the treatment of DPN. These include tricyclic
antidepressants, or TCAs, such as amitriptyline, anticonvulsants such as gabapentin, serotonin and
norepinephrine re-uptake inhibitors (e.g., duloxetine), and opioids (e.g., oxycodone).
Unfortunately, the use of these drugs is often limited by the extent of the pain relief provided
and the occurrence of significant central nervous system, or CNS, side effects such as dizziness,
somnolence, and confusion. Because of its limited systemic absorption into the blood, NP-1 topical
cream potentially fulfills the unmet need for a safe, better tolerated, and effective agent for
painful DPN.
Cancer pain represents a large unmet market. This condition is caused by the cancer tumor
itself as well as the side effects of cancer treatments, such as chemotherapy and radiotherapy.
According to Business Insights study, Pain Market Outlook for 2011, published in June 2006, over
5 million patients in the United States experience cancer-related pain. This pain can be placed in
three main areas: visceral, somatic and neuropathic. Visceral pain is caused by tissue damage to
organs and may be described as gnawing, cramping, aching or sharp. Somatic pain refers to the skin,
muscle or bone and is described as stabbing, aching, throbbing or pressure. Neuropathic pain is
caused by injury to, or compression of, the structures of the peripheral and central nervous
system. Chemotherapeutic agents, including vinca alkaloids, cisplatin and paclitaxel, are
associated with peripheral neuropathies. Neuropathic pain is often described as sharp, tingling,
burning or shooting.
EpiCeptTM NP-1
EpiCeptTM NP-1, or NP-1, is a prescription topical analgesic cream containing a
patented formulation of two FDA-approved drugs; amitriptyline, which is a widely-used
antidepressant, and ketamine, an NMDA antagonist that is used as an intravenous anesthetic. NP-1 is
designed to provide effective, long-term relief from the pain caused by peripheral neuropathies.
Since each of these ingredients has been shown to have significant analgesic effects and because
NMDA (N-methyl-D-aspartic acid) antagonists, such as ketamine, have demonstrated the ability to
enhance the analgesic effects of amitriptyline, we believe the combination is a good candidate for
the development of a new class of analgesics. We believe that NP-1 can be used in conjunction with
orally delivered analgesics, such as gabapentin. In January 2010, we received orphan drug
protection for NP-1 for the treatment of PHN.
NP-1 is an odorless, white vanishing cream that is applied twice daily and is quickly absorbed
into the applied area. We believe the topical delivery of its patented combination represents a
fundamentally new approach for the treatment of pain associated with peripheral neuropathy. In
addition, we believe that the topical delivery of our product candidate will significantly reduce
the risk of adverse side effects and drug to drug interactions associated with the systemic
delivery of the active ingredients. The results of our clinical trials to date have demonstrated
the safety of the cream for use for up to one year and a potent analgesic effect in subjects with
both post-herpetic neuralgia and other types of peripheral neuropathy, such as those with diabetic,
traumatic and surgical causes.
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Current Clinical Initiatives. In January 2009, we completed a Phase IIb, multi-center,
randomized, placebo controlled trial in approximately 360 patients evaluating the analgesic
properties and safety of NP-1 cream in patients with PHN. This trial compared the efficacy and
safety of NP-1 against both gabapentin, the leading drug prescribed for this indication, and
placebo. The first primary endpoint was the change in pain intensity over the four week duration
of the trial. The data demonstrated that NP-1 achieved statistically significant superior efficacy
compared with placebo (p=0.024). An additional primary endpoint, to demonstrate that NP-1 was not
inferior to gabapentin in reducing pain, was also met. A key secondary endpoint measured in the
trial from a responder analysis indicated that 63% of patients in the NP-1 treatment arm achieved a
reduction in pain scores of at least 30%, significantly higher than that of patients in the placebo
arm (p=0.033). Top-line results further indicate that NP-1 achieved a superior safety profile when
compared with gabapentin, especially with regard to dizziness and somnolence, as evaluated by the
reporting of adverse events.
In February 2008, we completed a Phase II clinical trial in 215 patients suffering from DPN.
The results of this double-blind, placebo-controlled study demonstrated that the primary endpoint,
the difference in changes in pain intensity between NP-1 and placebo over the four week duration of
the trial, nearly reached statistical significance (p=0.0715). The analgesic benefits of NP-1
continued to build over time during the course of the study. Key secondary endpoints measured in
the trial from a responder analysis indicate that 60% of patients in the NP-1 treatment arm
achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo
arm (p=0.076). In addition, 33% of patients in the NP-1 treatment arm achieved a reduction in pain
scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078). All pain
scores measured trended in favor of the NP-1 treated patients over the placebo group, indicative of
an analgesic effect in this type of peripheral neuropathic pain. We concluded that data derived
from the trial support the continued study of NP-1 in late-stage pivotal clinical trials.
In the third quarter of 2007, the National Cancer Institute, or NCI, initiated a multicenter,
randomized, placebo-controlled clinical trial in approximately 400 patients evaluating the effects
of NP-1 cream in treating patients suffering from chemotherapeutic induced peripheral neuropathy,
also known as CPN. CPN may affect 50% of women undergoing treatment for breast cancer. A common
therapeutic agent for the treatment of advanced breast cancer is paclitaxel, and as many as 80% of
the patients with advanced breast cancer experience some signs and symptoms of CPN, such as
burning, tingling pain associated sometimes with mild muscular weakness, after high dose paclitaxel
administration. The study is being conducted within a network of approximately 25 sites under the
direction of the NCI funded Community Clinical Oncology Program, or CCOP. This trial is expected to
complete in 2010.
Back Pain
In the United States, 80% of the U.S. population will experience significant back pain at some
point. Back pain ranks second only to headaches as the most frequently experienced pain. It is the
leading reason for visits to neurologists and orthopedists and the second most frequent reason for
physician visits overall. Both acute and chronic back pain are typically treated with NSAIDs,
muscle relaxants or opioid analgesics. All of these drugs can subject the patient to systemic
toxicity, significant adverse side effects and drug to drug interactions.
LidoPAIN BP
LidoPAIN BP is a prescription analgesic non-sterile patch designed to provide sustained
topical delivery of lidocaine for the treatment of acute or recurrent lower back pain of moderate
severity of less than three months duration. The LidoPAIN BP patch contains 140 mg of lidocaine in
a 19.0% concentration, is intended to be applied once daily and can be worn for a continuous
24-hour period. The patchs adhesive is strong enough to permit a patient to move and conduct
normal daily activities but can be removed easily. We licensed LidoPAIN BP and certain other
technology to Endo Pharmaceuticals in December 2003.
Current Clinical Initiatives. We have suspended development of LidoPAIN BP and focused our
resources on our other compounds that we believe present a better risk/reward opportunity. Further
collaboration work with Endo has been postponed pending an affirmation that they have interest in
developing a lidocaine patch for the treatment of back pain.
Our Strategic Alliances
Meda
In January 2010, we entered into an exclusive commercialization agreement for
Ceplene® with Meda AB, a leading international specialty pharmaceutical company based in
Stockholm, Sweden. Under the terms of the agreement, we granted Meda the right to market Ceplene
in Europe and several other countries including Japan, China, and Australia. Pursuant to the terms
of the agreement, we received a $3 million fee and will receive an additional $2 million upon the
first commercial launch of Ceplene®
in a major European market. Additional payments include a $5 million payment upon achievement
of a regulatory milestone and up to $30 million in sales-based milestones that commence upon
attainment of at least $50 million in annual sales. We will receive an escalating double digit
percent royalty on net sales in the covered territories and will be responsible for Ceplenes
commercial supply.
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Myriad
We licensed the MX90745 series of caspase-inducer anti-cancer compounds to Myriad in 2003.
Under the terms of the agreement, we granted to Myriad a research license to develop and
commercialize any drug candidates from the series of compounds with a non-exclusive, worldwide,
royalty-free license, without the right to sublicense the technology. Myriad is responsible for the
worldwide development and commercialization of any drug candidates from the series of compounds. We
also granted to Myriad a worldwide royalty bearing development and commercialization license with
the right to sublicense the technology. The agreement required Myriad to make research payments to
us totaling $3 million which was paid and recognized as revenue prior January 4, 2006. Assuming the
successful commercialization of the compound for the treatment of cancer, we are also eligible to
receive up to $24.0 million upon the achievement of certain milestones and the successful
commercialization of compounds for treatment of cancer as well as a royalty on product sales. In
March 2007, Myriad initiated Phase II clinical trials for AzixaTM (MPC6827), a MX90745
series compound. In March 2008, we received a milestone payment of $1.0 million following dosing
of the first patient in these trials.
Durect
In December 2006, we entered into a license agreement with DURECT Corporation (DURECT),
pursuant to which we granted DURECT the exclusive worldwide rights to certain of our intellectual
property for a transdermal patch containing bupivacaine for the treatment of back pain. Under the
terms of the agreement, we received a $1.0 million upfront payment. In September 2008, we amended
our license agreement with DURECT. Under the terms of the amended agreement, we granted DURECT
royalty-free, fully paid up, perpetual and irrevocable rights to the intellectual property licensed
as part of the original agreement in exchange for a cash payment of $2.25 million from DURECT.
Endo Pharmaceuticals
In December 2003, we entered into a license agreement with Endo under which we granted Endo
(and its affiliates) the exclusive (including as to us and our affiliates) worldwide right to
commercialize LidoPAIN BP. We also granted Endo worldwide rights to use certain of our patents for
the development of certain other non-sterile, topical lidocaine patches, including Lidoderm, Endos
non-sterile topical lidocaine-containing patch for the treatment of chronic lower back pain. Upon
the execution of the Endo agreement, we received a non-refundable payment of $7.5 million. Other
potential compensation under this agreement includes additional milestone payments of up to $82.5
million related to both our LidoPAIN BP product and Lidoderm and a royalty on net sales of LidoPAIN
BP. We do not expect to receive further compensation under this agreement.
The last published clinical study of Lidoderm in back pain occurred in 2005. We believe that
no measurable progress has occurred with Lidoderm for back pain and do not expect further revenue
from this license at this time.
Manufacturing
We currently intend to outsource all of our manufacturing activities. We believe that this
strategy will enable us to direct operational and financial resources to the development of our
product candidates rather than diverting resources to establishing a manufacturing infrastructure.
Under the terms of a supply agreement with Meda, we are responsible for supplying commercial
quantities of Ceplene® based on Medas estimate of sales in the licensed territories.
We have entered into arrangements with qualified third parties for the manufacture of
Ceplene® and for the formulation and manufacture of our clinical supplies. We may enter
into additional written supply agreements in the future . We generally purchase our supplies from
current suppliers pursuant to purchase orders. We plan to use a single, separate third party
manufacturer for Ceplene® and each of our product candidates for which we are
responsible for manufacturing. In some cases, the responsibility to manufacture product, or to
identify suitable third party manufacturers, may be assumed by our licensees. We cannot assure you
that our current manufacturers can successfully increase their production to meet full commercial
demand. We believe that in most cases there are several manufacturing sources available to us,
including our current manufacturers, which can meet our commercial supply requirements on
commercially reasonable terms. We will continue to look for and secure the appropriate
manufacturing capabilities and capacity to ensure commercial supply at the appropriate time.
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Sales and Marketing
We hired a senior vice president of sales and marketing in November 2009 in anticipation of
the start of commercial activities for Ceplene® in the United States and Europe. In
order to commercially market Ceplene® or any of our product candidates in the United
States upon receipt of marketing approval, we must either develop an internal sales and marketing
infrastructure or collaborate with third parties with sales and marketing expertise. We have
retained the rights to commercialize NP-1 and crinobulin worldwide and to market Ceplene globally
except for Europe and certain Pacific rim countries. In addition, we have granted Myriad exclusive
worldwide commercialization rights, with rights to sublicense, for AzixaTM. We will
likely market our products in international markets outside of North America through collaborations
with third parties. We intend to make decisions regarding internal sales and marketing of our
product candidates on a product-by-product and country-by-country basis.
Intellectual Property
Our commercial success will depend in part on obtaining and maintaining patent protection and
trade secret protection of our technologies and drug candidates as well as successfully defending
these patents against third-party challenges. We have various compositions of matter and use
patents, which have claims directed to our product candidates or their methods of use. Our patent
policy is to retain and secure patents for the technology, inventions and improvements related to
our core portfolio of product candidates. We also rely on trade secrets, technical know-how and
continuing innovation to develop and maintain our competitive position.
The following is a summary of the patent position relating to our three in-house product
candidates:
Ceplene® The intellectual property protection surrounding our histamine
technology includes 24 U.S. patents issued or allowed, with the term for the latest one expiring in
February 2023. Patents issued or pending in the international markets concern specific therapeutic
areas or manufacturing. Claims include the therapeutic administration of histamine or any H2
receptor agonist in the treatment of cancer, infectious diseases and other diseases, either alone
or in combination therapies, the novel synthetic method for the production of pharmaceutical-grade
histamine dihydrochloride, the mechanism of action including the binding receptor and pathway, and
the rate and route of administration.
Crinobulin The intellectual property protection regarding this compound is covered by two
issued U.S. patents , with the latest one expiring in May 2022 and one application pending covering
the composition and uses of this compound and structurally related analogs. Additional foreign
patent applications are pending in major pharmaceutical markets outside the United States.
EpiCeptTM NP-1 We own a U.S. patent with claims directed to a formulation
containing a combination of amitriptyline and ketamine, which can be used as a treatment for the
topical relief of pain, including neuropathic pain, that expires in August 2021. We also have a
license to additional patents, which expire in September 2015 and May 2018, and which have claims
directed to topical uses of tricyclic antidepressants, such as amitriptyline, and NMDA antagonists,
such as ketamine, as treatments for relieving pain, including neuropathic pain.
We may seek to protect our proprietary information by requiring our employees, consultants,
contractors, outside partners and other advisers to execute, as appropriate, nondisclosure and
assignment of invention agreements upon commencement of their employment or engagement. We also
require confidentiality or material transfer agreements from third parties that receive our
confidential data or materials.
We also rely on trade secrets to protect our technology, especially where we do not believe
patent protection is appropriate or obtainable. However, trade secrets are difficult to protect.
While we use reasonable efforts to protect our trade secrets, our employees, consultants,
contractors, partners and other advisors may unintentionally or willfully disclose information to
competitors. Enforcing a claim that a third party illegally obtained and is using trade secrets is
expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the
United States are sometimes less willing to protect trade secrets. Moreover, our competitors may
independently develop equivalent knowledge, methods and know-how.
The pharmaceutical, biotechnology and other life sciences industries are characterized by the
existence of a large number of patents and frequent litigation based upon allegations of patent
infringement. While our drug candidates are in clinical trials, and prior to commercialization, we
believe our current activities fall within the scope of the exemptions provided by 35 U.S.C.
Section 271(e) in the United States and Section 55.2(1) of the Canadian Patent Act, each of which
covers activities related to developing information for submission to the FDA and its counterpart
agency in Canada. As our drug candidates progress toward commercialization, the possibility of an
infringement claim against us increases. While we attempt to ensure that our drug
candidates and the methods we employ to manufacture them do not infringe other parties
patents and other proprietary rights, competitors or other parties may assert that we infringe on
their proprietary rights.
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For a discussion of the risks associated with our intellectual property, see Item 1A. Risk
Factors Risks Relating to Intellectual Property.
License Agreements
We have in the past licensed and will continue to license patents from collaborating research
groups and individual inventors.
Epitome/Dalhousie
In August 1999, we entered into a sublicense agreement with Epitome Pharmaceuticals Limited
under which we were granted an exclusive license to certain patents for the topical use of
tricyclic anti-depressants and NMDA antagonists as topical analgesics for neuralgia that were
licensed to Epitome by Dalhousie University. These and other patents cover the combination
treatment consisting of amitriptyline and ketamine in NP-1. This technology has been incorporated
into NP-1. In July 2007, we converted the sublicense agreement previously established with Epitome
Pharmaceuticals Limited, related to NP-1, into a direct license with Dalhousie University. Under
this new arrangement, we gained more favorable terms, including a lower maintenance fee obligation
and reduced royalty rate on future product sales.
We have been granted worldwide rights to make, use, develop, sell and market products
utilizing the licensed technology in connection with passive dermal applications. We are obligated
to make payments to Dalhousie upon achievement of specified milestones and to pay royalties based
on annual net sales derived from the products incorporating the licensed technology. We are
obligated to pay Dalhousie an annual maintenance fee until the license agreement expires or is
terminated, or an NDA for NP-1 is filed with the FDA, otherwise Dalhousie will have the option to
terminate the contract. The license agreement with Dalhousie terminates upon the expiration of the
last to expire licensed patent. The sublicense agreement with Epitome terminated in July 2007. In
each of the years 2009, 2008 and 2007, we paid Epitome a fee of $0.3 million. During 2009 and 2008,
we paid Dalhousie a maintenance fee of $0.5 million and $0.4 million, respectively. During 2007,
we paid Dalhousie a signing fee of $0.3 million, a maintenance fee of $0.4 million and a milestone
payment of $0.2 million upon the dosing of the first patient in a Phase III clinical trial for
NP-1. These payments were expensed to research and development.
Shire Biochem
In March 2004 and as amended in January 2005, we entered into a license agreement reacquiring
the rights to the MX2105 series of apoptosis inducer anti-cancer compounds from Shire BioChem,
Inc., formerly known as BioChem Pharma, Inc., who had previously announced that oncology would no
longer be a therapeutic focus of the companys research and development efforts. Under the
agreements, Shire BioChem agreed to assign and/or license to us rights it owned under or shared
under its oncology research program. The agreement requires that we provide Shire BioChem a portion
of any sublicensing payments we receive if we relicense the series of compounds, and make milestone
payments to Shire BioChem totaling up to $26 million, assuming the successful commercialization of
a compound for the treatment of a cancer indication, as well as pay a royalty on product sales. At
December 31, 2009, we accrued a license fee expense of $0.6 million upon the commencement of a
Phase I clinical trial for Crinobulin in 2006.
Hellstrand
In October 1999, we entered into a royalty agreement with Dr. Kristoffer Hellstrand under
which we have an exclusive license to certain patents for Ceplene® configured for the
systemic treatment of cancer, infectious diseases, autoimmune diseases and other medical
conditions. Under this agreement, a predecessor company paid Dr. Hellstrand $1 million in 1999 and
will owe a royalty of 1% of net sales. In November 2009 we expanded our collaboration with Dr.
Hellstrand by concluding a new agreement in which we acquired rights to develop certain new
compounds. As compensation for this agreement and for providing certain ongoing consulting
services, we awarded Dr. Hellstrand options to purchase 50,000 shares of our common stock and
agreed to pay a monthly consulting fee. At December 31, 2009, no royalties have been paid.
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Government Regulation
United States
The FDA and comparable state and local regulatory agencies impose substantial requirements
upon the clinical development, manufacture, marketing and distribution of drugs. These agencies and
other federal, state and local entities regulate research and development activities and the
testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping,
approval, advertising and promotion of our product candidates. In the United States, the FDA
regulates drugs under the Federal Food, Drug, and Cosmetic Act, and implementing regulations. The
process required by the FDA before our product candidates may be marketed in the United States
generally involves the following:
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completion of extensive pre-clinical laboratory tests, pre-clinical animal studies and
formulation studies all performed in accordance with the FDAs good laboratory practice, or
GLP, regulations; |
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submission to the FDA of an Investigational New Drug, or IND, application that must
become effective before clinical trials may begin; |
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performance of adequate and well-controlled clinical trials to establish the safety and
efficacy of the product candidate for each proposed indication; |
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submission of an NDA to the FDA; |
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities
at which the product is produced to assess compliance with current GMP, or cGMP,
regulations; and |
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FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of
the drug. |
The testing and approval process requires substantial time, effort and financial resources,
and we cannot be certain that any approvals for our product candidates will be granted on a timely
basis, if at all.
Pre-clinical Activities. Pre-clinical activities include laboratory evaluation of product
chemistry, formulation and stability, as well as studies to evaluate toxicity in animals. The
results of pre-clinical tests, together with manufacturing information and analytical data, are
submitted as part of an IND application to the FDA. The IND automatically becomes effective 30 days
after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or
questions about the conduct of the clinical trial, including concerns that human research subjects
will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must
resolve any outstanding concerns before the clinical trial can begin. Our submission of an IND, or
those of our collaborators, may not result in FDA authorization to commence a clinical trial. A
separate submission to an existing IND must also be made for each successive clinical trial
conducted during product development, and the FDA must grant permission before each clinical trial
can begin. Further, an independent institutional review board, or IRB, for each medical center
proposing to conduct the clinical trial must review and approve the plan for any clinical trial
before it commences at that center, and it must monitor the study until completed. The FDA, the IRB
or the sponsor may suspend a clinical trial at any time on various grounds, including a finding
that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing
also must satisfy extensive Good Clinical Practice, or GCP, regulations and regulations for
informed consent of subjects.
Clinical Trials. For purposes of NDA submission and approval, clinical trials are typically
conducted in the following three sequential phases, which may overlap:
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Phase I: Studies are initially conducted in a limited population to test the drug
candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion
in healthy humans or, on occasion, in subjects. In some cases, a sponsor may decide to
run what is referred to as a Phase Ib evaluation, which is a second safety-focused
Phase I clinical trial typically designed to evaluate the impact of the drug candidate
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Phase II: Studies are generally conducted in a limited patient population to identify
possible adverse effects and safety risks, to determine the efficacy of the drug
candidate for specific targeted indications and to determine dose tolerance and optimal
dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain
information prior to beginning larger and more expensive Phase III clinical trials. In
some instances, a sponsor may decide to run what is referred to as a Phase IIa
clinical trial, which is designed to provide dose-ranging and additional safety and
pharmaceutical data. In other cases, a sponsor may decide to run what is referred to as a
Phase IIb evaluation, which is a second, confirmatory Phase II clinical trial that
could, if positive and accepted by the FDA, serve as a pivotal clinical trial in the
approval of a drug candidate. |
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Phase III: These are commonly referred to as pivotal studies. When Phase II clinical
trials demonstrate that a dose range of the drug candidate is effective and has an
acceptable safety profile, Phase III clinical trials are undertaken in large patient
populations to further evaluate dosage, to provide substantial evidence of clinical
efficacy and to further test for safety in an expanded and diverse patient population at
multiple, geographically dispersed clinical trial sites. |
In some cases, the FDA may give conditional approval of an NDA for a drug candidate on the
sponsors agreement to conduct additional clinical trials to further assess the drugs safety and
effectiveness after NDA approval. Such post-approval trials are typically referred to as Phase IV
clinical trials.
New Drug Application. The results of drug candidate development, pre-clinical testing,
chemistry and manufacturing controls and clinical trials are submitted to the FDA as part of an
NDA. The NDA also must contain extensive manufacturing information. Once the submission has been
accepted for filing, by law the FDA has 180 days to review the application and respond to the
applicant. The review process is often significantly extended by FDA requests for additional
information or clarification. The FDA may refer the NDA to an advisory committee for review,
evaluation and recommendation as to whether the application should be approved. The FDA is not
bound by the recommendation of an advisory committee, but it generally follows such
recommendations. The FDA may deny approval of an NDA if the applicable regulatory criteria are not
satisfied, or it may require additional clinical data or an additional pivotal Phase III clinical
trial. Even if such data is submitted, the FDA may ultimately decide that the NDA does not satisfy
the criteria for approval. Data from clinical trials are not always conclusive and the FDA may
interpret data differently than we do. Once issued, the FDA may withdraw drug approval if ongoing
regulatory requirements are not met or if safety problems occur after the drug reaches the market.
In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance
programs to monitor the effect of approved products that have been commercialized, and the FDA has
the power to prevent or limit further marketing of a drug based on the results of these
post-marketing programs. Drugs may be marketed only for the approved indications and in accordance
with the provisions of the approved label. Further, if there are any modifications to the drug,
including changes in indications, labeling or manufacturing processes or facilities, we may be
required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require us to
develop additional data or conduct additional pre-clinical studies and clinical trials.
Satisfaction of FDA regulations and requirements or similar requirements of state, local and
foreign regulatory agencies typically takes several years, and the actual time required may vary
substantially based upon the type, complexity and novelty of the product or disease. Government
regulation may delay or prevent marketing of drug candidates for a considerable period of time and
impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant
approvals for new indications for our drug candidates on a timely basis, if at all. Even if a drug
candidate receives regulatory approval, the approval may be significantly limited to specific
usages, patient populations and dosages. Further, even after regulatory approval is obtained, later
discovery of previously unknown problems with a drug may result in restrictions on the drug or even
complete withdrawal of the drug from the market. Delays in obtaining, or failures to obtain,
regulatory approvals for any of our drug candidates would harm its business. In addition, we cannot
predict what additional governmental regulations may arise from future U.S. governmental action.
Any drugs manufactured or distributed by us or our collaborators pursuant to FDA approvals are
subject to continuing regulation by the FDA, including record keeping requirements and reporting of
adverse experiences associated with the drug. Drug manufacturers and their subcontractors are
required to register their establishments with the FDA and certain state agencies and are subject
to periodic unannounced inspections by the FDA and certain state agencies for compliance with
ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation
requirements upon us and our third-party manufacturers. Failure to comply with the statutory and
regulatory requirements can subject a manufacturer to potential legal or regulatory action, such as
warning letters, suspension of manufacturing, seizure of product, injunctive action or civil
penalties. We cannot be certain that we or our present or future third-party manufacturers or
suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory
requirements. If our present or future third-party manufacturers or suppliers are not able to
comply with these requirements, the FDA may halt our clinical trials, require us to recall a drug
from distribution, or withdraw approval of the NDA for that drug.
The FDA closely regulates the post-approval marketing and promotion of drugs, including
standards and regulations for direct-to-consumer advertising, off-label promotion,
industry-sponsored scientific and educational activities and promotional activities involving the
Internet. A company can make only those claims relating to safety and efficacy that are approved by
the FDA. Failure to comply with these requirements can result in adverse publicity, warning
letters, corrective advertising and potential civil and criminal penalties. Physicians may
prescribe legally available drugs for uses that are not described in the drugs labeling and that
differ from those tested by us and approved by the FDA. Such off-label uses are common across
medical specialties. Physicians may believe that such off-label uses are the best treatment for
many patients in varied circumstances. The FDA does not regulate the behavior of physicians in
their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers
communications regarding off-label use.
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Section 505(b)(2) Drug Applications. Once an FDA-approved new drug is no longer
patent-protected, another company may sponsor a new indication, a new use or put the drug in a new
dosage form. Each new indication from a different company requires an NDA filing. As an alternate
path to FDA approval for new or improved formulations of previously approved products, a company
may file a Section 505(b)(2) NDA. Section 505(b)(2) permits the filing of an NDA where at least
some of the information required for approval comes from studies not conducted by or for the
applicant and for which the applicant has not obtained a right of reference. However, this NDA does
not have to contain all of the information or data that was submitted with the original NDA because
of the FDAs prior experience with the drug product. An original NDA for an FDA-approved new drug
would have required numerous animal toxicology studies that have been reviewed by the FDA. These
can be referenced in the 505(b)(2) NDA submitted by the new applicant. Many studies in humans that
support the safety of the drug product may be in the published literature. The FDA allows the new
sponsor company to submit these publications to support its 505(b)(2) NDA. By allowing the new
sponsor company to use this information, the time and cost required to obtain approval for a drug
product for the new indication can be greatly reduced. The FDA may also require companies to
perform additional studies or measurements to support the change from the approved product. The FDA
may then approve the new product candidate for all or some of the label indications for which the
referenced product has been approved, as well as for any new indication sought by the Section
505(b)(2) applicant.
To the extent that the Section 505(b)(2) applicant is relying on studies conducted for an
already approved product, the applicant is required to certify to the FDA concerning any patents
listed for the approved product in the FDAs Orange Book publication. Specifically, the applicant
must certify that: (i) the required patent information has not been filed; (ii) the listed patent
has expired; (iii) the listed patent has not expired, but will expire on a particular date and
approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be
infringed by the new product. If the applicant does not challenge the listed patents, the Section
505(b)(2) application will not be approved until all the listed patents claiming the referenced
product have expired. The Section 505(b)(2) application also will not be approved until any
non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed
in the Orange Book for the referenced product has expired.
Foreign Regulation
Whether or not we obtain FDA approval for a product, we must obtain approval of a product by
the comparable regulatory authorities of foreign countries before we can commence clinical trials
or marketing of the product in those countries. The approval process varies from country to
country, and the time may be longer or shorter than that required for FDA approval. The
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement
also vary greatly from country to country. Although governed by the applicable country, clinical
trials conducted outside of the United States typically are administered with the three-phase
sequential process that is discussed above under Government Regulation United States. However,
the foreign equivalent of an IND is not a prerequisite to performing pilot studies or Phase I
clinical trials.
Under European Union regulatory systems, we may submit marketing authorization applications
either under a centralized or decentralized procedure. The centralized procedure, which is required
for oncology products and is available for medicines produced by biotechnology or which are highly
innovative, provides for the grant of a single marketing authorization that is valid for all member
states. This authorization is a marketing authorization application, or MAA. The decentralized
procedure provides for mutual recognition of national approval decisions. Under this procedure, the
holder of a national marketing authorization may submit an application to the remaining member
states. Within 90 days of receiving the applications and assessment report, each member state must
decide whether to recognize approval. This procedure is referred to as the mutual recognition
procedure.
In addition, regulatory approval of prices is required in most countries other than the United
States. We face the risk that the resulting prices would be insufficient to generate an acceptable
return to us or our collaborators.
Corporate Information
We were incorporated in Delaware in March 1993. We have two wholly-owned subsidiaries, EpiCept
GmbH, based in Munich, Germany, which is engaged in research and development activities on our
behalf and Maxim Pharmaceuticals, Inc. which we acquired in January 2006. Our principal executive
offices are located at 777 Old Saw Mill River Road, Tarrytown, NY, and our telephone number is
(914) 606-3500. Our website address is www.epicept.com. Our website, and the information contained
in our website, is not a part of this annual report.
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Employees
As of March 5, 2010, our workforce consists of 17 full-time employees, three of whom hold a
Ph.D. or M.D., and one of whom holds another advanced degree. We have no collective bargaining
agreements with our employees and have not experienced any work stoppages. We believe that our
relations with our employees are good.
Research and Development
Since our inception, we have made substantial investments in research and development. In the
years ended December 31, 2009, 2008 and 2007, we incurred research and development expenses of
$11.6 million, $12.6 million and $15.3 million, respectively.
Availability of SEC Filings
We have filed reports, proxy statements and other information with the SEC. Copies of our
reports, proxy statements and other information may be inspected and copied at the public reference
facilities maintained by the SEC at SEC Headquarters, Public Reference Section, 100 F Street, N.E.,
Washington D.C. 20549. The public may obtain information on the operation of the SECs public
reference facilities by calling the SEC at 1-800-SEC-0330. The SEC maintains a website that
contains reports, proxy statements and other information regarding us. The address of the SEC
website is http://www.sec.gov. We will also provide copies of our Forms 8-K, 10-K, 10-Q,
Proxy and Annual Report at no charge available through our website at www.epicept.com as soon as
reasonably practicable after filing electronically such material with the SEC. Copies are also
available, without charge, from EpiCept Corporation, 777 Old Saw Mill River Road, Tarrytown, NY,
10591.
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ITEM 1A. RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully
consider the risk factors described below as well as the other information contained in this Annual
Report before buying shares of our common stock. If any of the following risks or uncertainties
occurs, our business, financial conditions and operating results could be materially and adversely
affected. As a result, the trading price of our common stock could decline and you may lose all or
a part of your investment in our common stock.
Risks Relating to our Financial Condition
We have limited liquidity and, as a result, may not be able to meet our obligations.
As of December 31, 2009 we had approximately $5.1 million in cash and cash equivalents. In
January 2010 we received $3 million from Meda AB in connection with the signing of the
Ceplene® European marketing and distribution agreement with Meda AB. Meda is also
required to pay an additional $2 million upon its commercial launch of Ceplene® and a royalty on
net sales. Our anticipated average monthly cash operating expenses in 2010 is approximately $1.6
million per month. In addition, we are required to make interest and principal payments to our
lender tbg on each of June 30, 2010 and December 31, 2010 in the amount of approximately $0.5
million. We believe that our cash is sufficient to fund operations into the third quarter 2010.
We may receive cash from certain of our licensing partners during 2010 for achievement of clinical
milestones, and we may raise additional funds through the issuance of debt and/or equity to meet
our cash needs. To conserve cash, we may delay or cancel some of our planned development
activities that are not related to Ceplene® during 2010.
We plan to out license our NP-1 compound to a third party who will agree to complete clinical
development and commercialize the product upon receipt of necessary regulatory approvals.
Discussions with prospective partners are continuing, however at this time we are unable to
determine whether or when such an agreement might be concluded or the amount of any fees that may
be paid to us in 2010 in connection with the agreement.
In February 2010, we established an At-the-Market offering program through which we may,
from time to time, offer and sell shares of our common stock having an aggregate offering price of
up to $15.0 million from time to time through our sales agent. Sales of the shares, if any, will
be made by means of ordinary brokers transactions on The Nasdaq Capital Market or, to the extent
allowable by law, the Nasdaq OMX Stockholm Exchange, at market prices. Additionally, under the
terms of the sales agreement, we may also sell shares of our common stock through the sales agent
on The Nasdaq Capital Market or, to the extent allowable by law, the Nasdaq OMX Stockholm Exchange,
or otherwise, at negotiated prices or at prices related to the prevailing market price. We will
designate the maximum amount of shares of common stock to be sold on a daily basis as we and our
sales agent may agree. We plan to utilize this program at such times and in such amounts so as to
minimize disruption to the trading of our stock, and therefore in times of low trading volume we
may severely limit or refrain from using the program. If we are unable to meet our liquidity needs
through this program, we may seek alternative sources of equity and/or debt.
If additional funds are raised by issuing equity, substantial dilution to existing
shareholders may result. If we fail to obtain capital when required, we may be forced to delay,
scale back, or eliminate some or all of our commercialization efforts for Ceplene and our research
and development programs or to cease operations entirely.
We have a history of losses and have never generated revenue from product sales and we expect to
incur substantial losses in the future.
We have incurred significant losses since our inception, and we expect that we will experience
net losses and negative cash flow for the foreseeable future. Since our inception in 1993, we have
incurred significant net losses in each year. Our losses have resulted principally from expenses
incurred in connection with our development activities and from general and administrative expenses
associated with our operations. Our net loss for the fiscal year ended December 31, 2009 and 2008
was $39.0 and $25.4 million, respectively. As of December 31, 2009 and 2008, our accumulated
deficit was $235.0 and $196.2 million, respectively. We may never generate sufficient net revenue
to achieve or sustain profitability.
We expect to continue to incur significant expenses over the next several years as we:
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prepare to commercialize Ceplene® in the North America upon receipt of
necessary marketing approvals; |
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continue to conduct clinical trials for Ceplene® and our product
candidates; |
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seek regulatory approvals for Ceplene® and our product candidates; |
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develop, formulate and commercialize our product candidates; |
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implement additional internal controls and reporting systems and further develop our
corporate infrastructure; |
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acquire or in-license additional products or technologies or expand the use of our
technologies; and |
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maintain, defend and expand the scope of our intellectual property. |
We expect that we will have large fixed expenses in the future, including significant expenses
for research and development and selling, general and administrative expenses. We will need to
generate significant revenues to achieve and maintain profitability. If we cannot successfully
develop, obtain regulatory approvals for and commercialize our product candidates, we will not be
able to generate significant revenue from product sales or achieve profitability in the future. As
a result, our ability to achieve and sustain profitability will depend on our ability to generate
and sustain substantially higher revenue while maintaining reasonable cost and expense levels.
We may not be able to continue as a going concern.
Our recurring losses from operations and our stockholders deficit raise substantial doubt
about our ability to continue as a going concern and as a result our independent registered public
accounting firm included an explanatory paragraph in its report on our consolidated financial
statements for the year ended December 31, 2009, which is included herein, with respect to this
uncertainty. We will need to generate significant revenue from the sale of Ceplene® or
raise additional capital to continue to operate as a going concern. In addition, the perception
that we may not be able to continue as a going concern may cause others to choose not to deal with
us due to concerns about our ability to meet our contractual obligations and may adversely affect
our ability to raise additional capital.
Our quarterly financial results are likely to fluctuate significantly, which could have an adverse
effect on our stock price.
Our quarterly operating results will be difficult to predict and may fluctuate significantly
from period to period, particularly because we are a relatively small company and we have not
generated any meaningful revenue to date. The level of our revenues and expenses and our results of
operations at any given time could fluctuate as a result of any of the following factors:
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pre-marketing and commercialization expenses related to the anticipated launches of
Ceplene® in North America; |
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research and development expenses incurred and other operating expenses; |
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results of our clinical trials; |
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our ability to obtain regulatory approval for our product candidates; |
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our ability to achieve milestones under our strategic relationships on a timely basis
or at all; |
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timing of new product offerings, acquisitions, licenses or other significant events
by us or our competitors; |
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regulatory approvals and legislative changes affecting the products we may offer or
those of our competitors; |
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our ability to establish and maintain a productive sales force; |
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demand and pricing of any of our products; |
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physician and patient acceptance of our products; |
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levels of third-party reimbursement for our products; |
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interruption in the manufacturing or distribution of our products; |
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the effect of competing technological and market developments; |
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litigation involving patents, licenses or other intellectual property rights; and |
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product failures or product liability lawsuits. |
With the exception of Ceplene®, we have not yet obtained regulatory approval for
any of our product candidates. In addition, we do not manufacture products ourselves or conduct
significant sales and marketing activities. Consequently, it is difficult to make any predictions
about our future success, viability or profitability based on our historical operations. It is also
difficult to predict the timing of the achievement of various milestones under our strategic
relationships. In addition, our operating expenses may continue to increase as we develop product
candidates and build commercial capabilities. Accordingly, we may experience significant quarterly
losses.
Because of these factors, our operating results in one or more future quarters may fail to
meet the expectations of securities analysts or investors, which could cause our stock price to
decline significantly.
We have had limited operating activities, which may make it difficult for you to evaluate the
success of our business to date and to assess our future viability.
Our activities to date have been limited to organizing and staffing our operations, acquiring,
developing and securing our technology, licensing product candidates, and undertaking preclinical
and clinical studies and clinical trials. With the exception of Ceplene®, we have not
yet demonstrated an ability to obtain regulatory approval, manufacture products or conduct sales
and marketing activities. Consequently, it is difficult to make any predictions about our future
success, viability or profitability based on our historical operations.
Clinical and Regulatory Risks
Other than the marketing authorization for Ceplene® in the European Union, we currently
have no products approved for sale and we cannot guarantee you that we will ever obtain regulatory
approval for such other product candidates, which could delay or prevent us from being able to
generate revenue from product sales.
All of our product candidates are subject to extensive government regulations related to
development, clinical trials, manufacturing and commercialization. The process of obtaining FDA,
European Medicines Agency for the Evaluation of Medicinal Products, or EMEA, and other governmental
and similar international regulatory approvals is costly, time consuming, uncertain and subject to
unanticipated delays. The FDA, EMEA and similar international regulatory authorities may not
ultimately approve the candidate for commercial sale in any jurisdiction. Despite the fact we
received the marketing authorization for Ceplene® in the European Union, we may not
receive regulatory approval outside of the European Union, including in the United States or
Canada. The FDA, EMEA and similar international regulators may refuse to approve an application for
approval of a drug candidate if they believe that applicable regulatory criteria are not satisfied.
The FDA, EMEA or similar international regulators may also require additional testing for safety
and efficacy. Any failure or delay in obtaining these approvals could prohibit or delay us from
marketing product candidates. If our other product candidates do not meet applicable regulatory
requirements for approval, we may not have the financial resources to continue research and
development of these product candidates and we may not generate revenues from the commercial sale
of any of our products.
To obtain regulatory approval for our other product candidates, we or our partners must
conduct extensive human tests, which are referred to as clinical trials, as well as meet other
rigorous regulatory requirements. Satisfaction of all regulatory requirements typically takes many
years and requires the expenditure of substantial resources.
We currently have several product candidates in various stages of clinical testing. All of our
product candidates are prone to the risks of failure inherent in drug development and testing.
Product candidates in later-stage clinical trials may fail to show desired safety and efficacy
traits despite having progressed through initial clinical testing. In addition, the data collected
from clinical trials of our product candidates may not be sufficient to support regulatory
approval, or regulators could interpret the data differently than we do. The regulators may require
us or our partners to conduct additional clinical testing, in which case we would have to expend
additional time and resources. The approval process may also be delayed by changes in government
regulation, future legislation or administrative action or changes in regulatory policy that occur
prior to or during regulatory review.
We and other drug development companies have suffered set backs in late-stage clinical trials
even after achieving promising results in early stage development. Accordingly, the results from
completed preclinical studies and early stage clinical trials may not be predictive of results in
later stage trials and may not be predictive of the likelihood of regulatory approval. Any failure
or
significant delay in completing clinical trials for our product candidates, or in receiving
regulatory approval for the sale of our product candidates, may severely harm our business and
delay or prevent us from being able to generate revenue from product sales, and our stock price
will likely decline.
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We may not be able to obtain regulatory approval in the United States for Ceplene®, our
lead product candidate, which could delay or prevent us from being able to generate revenue from
sales of Ceplene®, and require additional expenditures.
None of our products has received
regulatory approval in the United States. In January 2009, we had a pre-New Drug Application (NDA) meeting with
the U.S. Food and Drug Administration (FDA) to discuss our anticipated NDA submission for Ceplene® as remission
maintenance therapy for AML patients in first complete remission. At the meeting, the FDA identified significant
issues that should be addressed in the application. It was proposed that certain new data be provided in the submission,
including statistical data further supporting the incremental effectiveness of Ceplene® given in conjunction with
low-dose IL-2 and data showing the lack of significant efficacy of IL-2 as a monotherapy for remission maintenance of AML.
In addition to this data, we intend to submit data supporting Leukemia-Free Survival as an appropriate endpoint in the pivotal
Phase III study for Ceplene®, as compared with Overall Survival. The FDA also indicated that we should submit
additional manufacturing data supporting a commercially feasible product. Notwithstanding our ability or
willingness to provide this information, the FDA may not accept our application for filing, which means the
FDA will not review our NDA, or even if it files our NDA it may recommend that our NDA not be approved.
Despite the efforts we have made to comply with FDA requirements, those efforts may be
insufficient to meet the FDAs requirements to accept our NDA submission. If the FDA accepts our
submission, we may be unsuccessful in our efforts to obtain a marketing approval from the FDA. In
the event we do not obtain marketing approval, we may appeal, but such an appeal may not be
successful. A negative decision would delay or prevent us from generating revenue from product
sales of Ceplene® in the United States for the foreseeable future and may require us to
conduct additional costly and time-consuming clinical trials.
The FDA may also require additional testing for safety and efficacy. Any failure or delay in
obtaining a filing decision or an approval could prohibit or delay us from marketing product candidates. If our
product candidates do not meet applicable regulatory requirements for approval, we may not have the
financial resources to continue research and development of these product candidates, and we may
not generate revenues from the commercial sale of any of our products in the U.S.
We may not be able to maintain data protection in Canada for Ceplene®, which could
limit our ability to generate revenue from sales of
Ceplene® in Canada and result in a
withdrawal of our application for approval.
In November 2009, Health Canada accepted for review a New Drug Submission, or NDS, for
Ceplene® for the treatment of AML in Canada. We received a denial for data protection
for
Ceplene® in Canada in the fourth quarter of 2009. We are currently appealing this
denial for data protection and a decision is expected prior to the approval decision date in the
fourth quarter of 2010. If our appeal does not result in a positive outcome, we may withdraw our
application for approval of Ceplene® in Canada.
Clinical trial designs that were discussed with regulatory authorities prior to their commencement
may subsequently be considered insufficient for approval at the time of application for regulatory
approval.
We or our partners discuss with and obtain guidance from regulatory authorities on clinical trial
protocols. Over the course of conducting clinical trials, circumstances may change, such as
standards of safety, efficacy or medical practice, which could affect regulatory authorities
perception of the adequacy of any of our clinical trial designs or the data we develop from our
studies. Changes in circumstances could affect our ability to conduct clinical trials as planned.
Even with successful clinical safety and efficacy data, we may be required to conduct additional,
expensive trials to obtain regulatory approval.
We may not be able to maintain European Union regulatory approval for Ceplene®, our
lead product candidate, which could delay or prevent us from being able to generate revenue from
sales of Ceplene® and require additional expenditures.
Ceplene® is our lead product candidate and our only product candidate currently
under regulatory consideration. In July 2008, the European Committee for Medicinal Products for
Human Use, or CHMP, of the EMEA recommended that Ceplene® be granted full marketing
authorization under the provision of Exceptional Circumstances for the remission maintenance and
prevention of relapse in patients with AML in first remission. In October 2008, Ceplene®
was granted full marketing authorization by the European Commission, which allows
Ceplene® to be marketed in the 27 member states of the European Union, as well as in
Iceland, Liechtenstein and Norway. Ceplene® is to be administered in conjunction with
low-dose interleukin-2 (IL-2). As part of granting the marketing authorization under Exceptional
Circumstances, we have agreed to perform two post-approval clinical studies, that have now been
combined into a single clinical study. The first part of the study will seek to further elucidate
the clinical pharmacology of Ceplene® by assessing certain biomarkers in AML patients in
first
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remission. The second part of the study will assess the effect of Ceplene®/IL-2 on the development of minimal residual disease
in the same patient population. We may not receive a positive outcome in this study, and our
marketing authorization in the European Union may be terminated. A negative outcome or terminated
marketing authorization would delay or prevent us from generating revenue from product sales of
Ceplene® and may require us to conduct additional costly and time-consuming clinical
trials. There is no assurance that we will be able to maintain governmental regulatory approvals to
market Ceplene® in Europe. If we are unable to maintain regulatory approval to market
Ceplene® in Europe, our business, financial condition and results of operations would be
materially and adversely affected.
If we receive regulatory approval, our marketed products will also be subject to ongoing FDA
and/or foreign regulatory agency obligations and continued regulatory review, and if we fail to
comply with these regulations, we could lose approvals to market any products, and our business
would be seriously harmed.
Following initial regulatory approval of any of our product candidates, we will be subject to
continuing regulatory review, including review of adverse experiences and clinical results that are
reported after our products become commercially available. This would include results from any
post-marketing tests or vigilance required as a condition of approval. The manufacturer and
manufacturing facilities we use to make any of our product candidates will also be subject to
periodic review and inspection by the FDA or foreign regulatory agencies. If a previously unknown
problem or problems with a product, manufacturing or laboratory facility used by us is discovered,
the FDA or foreign regulatory agency may impose restrictions on that product or on the
manufacturing facility, including requiring us to withdraw the product from the market. Any changes
to an approved product, including the way it is manufactured or promoted, often require FDA
approval before the product, as modified, can be marketed. We and our manufacturers will be subject
to ongoing FDA requirements for submission of safety and other post-market information. If we or
our manufacturers fail to comply with applicable regulatory requirements, a regulatory agency may:
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issue warning letters; |
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impose civil or criminal penalties; |
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suspend or withdraw regulatory approval; |
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suspend any ongoing clinical trials; |
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refuse to approve pending applications or supplements to approved applications; |
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impose restrictions on operations; |
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close the facilities of manufacturers; or |
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seize or detain products or require a product recall. |
In addition, the policies of the FDA or other applicable regulatory agencies may change and
additional government regulations may be enacted that could prevent or delay regulatory approval of
our product candidates. We cannot predict the likelihood, nature, or extent of adverse government
regulation that may arise from future legislation or administrative action, either in the United
States or abroad.
Any regulatory approval we receive for our product candidates will be limited to those indications
and conditions for which we are able to show clinical safety and efficacy.
Any regulatory approval that we may receive for our current or future product candidates will
be limited to those diseases and indications for which such product candidates are clinically
demonstrated to be safe and effective. For example, in addition to the FDA approval required for
new formulations, any new indication to an approved product also requires FDA approval. If we are
not able to obtain regulatory approval for a broad range of indications for our product candidates,
our ability to effectively market and sell our product candidates may be greatly reduced and may
harm our ability to generate revenue.
Our lead product candidate, Ceplene®, which when used concomitantly with low-dose
interleukin-2, is intended only for remission maintenance therapy in the treatment of AML for adult
patients in their first complete remission. Any other indications or uses of Ceplene®
would require additional regulatory approval for us to market Ceplene® for these
indications.
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While physicians may choose to prescribe drugs for uses that are not described in the
products labeling and for uses that differ from those tested in clinical studies and approved by
regulatory authorities, our regulatory approvals will be limited to those
indications that are specifically submitted to the regulatory agency for review. These
off-label uses are common across medical specialties and may constitute the best treatment for
many patients in varied circumstances. Regulatory authorities in the United States generally do not
regulate the behavior of physicians in their choice of treatments. Regulatory authorities do,
however, restrict communications by pharmaceutical companies on the subject of off-label use. If
our promotional activities fail to comply with these regulations or guidelines, we may be subject
to warnings from, or enforcement action by, these authorities. In addition, our failure
to follow regulatory rules and guidelines relating to promotion and advertising may cause the
regulatory agency to delay its approval or refuse to approve a product, the suspension or
withdrawal of an approved product from the market, recalls, fines, disgorgement of money, operating
restrictions, injunctions or criminal prosecutions, any of which could harm our business.
The results of our clinical trials are uncertain, which could substantially delay or prevent us
from bringing our product candidates to market.
Before we can obtain regulatory approval for a product candidate, we must undertake extensive
clinical testing in humans to demonstrate safety and efficacy to the satisfaction of the FDA or
other regulatory agencies. Clinical trials are very expensive and difficult to design and
implement. The clinical trial process is also time consuming. The commencement and completion of
our clinical trials could be delayed or prevented by several factors, including:
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delays in obtaining regulatory approvals to commence or continue a study; |
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delays in reaching agreement on acceptable clinical trial parameters; |
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slower than expected rates of patient recruitment and enrollment; |
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inability to demonstrate effectiveness or statistically significant results in our
clinical trials; |
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unforeseen safety issues; |
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uncertain dosing issues; |
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inability to monitor patients adequately during or after treatment; and |
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inability or unwillingness of medical investigators to follow our clinical protocols. |
We cannot assure you that our planned clinical trials will begin or be completed on time or at
all, or that they will not need to be restructured prior to completion. Significant delays in
clinical testing will impede our ability to commercialize our product candidates and generate
revenue from product sales and could materially increase our development costs. Completion of
clinical trials may take several years or more, but the length of time generally varies according
to the type, complexity, novelty and intended use of a drug candidate. The cost of clinical trials
may vary significantly over the life of a project as a result of differences arising during
clinical development, including:
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the number of sites included in the trials; |
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the length of time required to enroll suitable patient subjects; |
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the number of patients that participate in the trials; |
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the number of doses that patients receive; |
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the duration of follow-up with the patient; |
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the product candidates phase of development; and |
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the efficacy and safety profile of the product. |
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The use of FDA-approved therapeutics in certain of our pain product candidates could require us to
conduct additional preclinical studies and clinical trials, which could increase development costs
and lengthen the regulatory approval process.
Certain of our pain product candidates utilize proprietary formulations and topical delivery
technologies to administer FDA-approved pain management therapeutics. We may still be required to
conduct preclinical studies and clinical trials to determine if our product candidates are safe and
effective. In addition, we may also be required to conduct additional preclinical studies and Phase
I clinical trials to establish the safety of the topical delivery of these therapeutics and the
level of absorption of the therapeutics into the bloodstream. The FDA may also require us to
conduct clinical studies to establish that our delivery mechanisms are safer or more effective than
the existing methods for delivering these therapeutics. As a result, we may be required to conduct
complex clinical trials, which could be expensive and time-consuming and lengthen the anticipated
regulatory approval process.
In some instances, we rely on third parties, over which we have little or no control, to conduct
clinical trials for our products and their failure to perform their obligations in a timely or
competent manner may delay development and commercialization of our product candidates.
The nature of clinical trials and our business strategy requires us to rely on clinical
research centers and other third parties to assist us with clinical testing and certain research
and development activities, such as our agreement with Myriad Pharmaceuticals, Inc. related to the
MX90745 series of apoptosis-inducer anti-cancer compounds. As a result, our success is dependent
upon the success of these third parties in performing their responsibilities. We cannot directly
control the adequacy and timeliness of the resources and expertise applied to these activities by
such third parties. If such contractors do not perform their activities in an adequate or timely
manner, the development and commercialization of our product candidates could be delayed. In
addition, we rely on Myriad for research and development related to the MX90745 series of
apoptosis-inducer anti-cancer compounds. We may enter into similar agreements from time to time
with additional third parties for our other product candidates whereby these third parties
undertake significant responsibility for research, clinical trials or other aspects of obtaining
FDA approval. As a result, we may face delays if Myriad or these additional third parties do not
conduct clinical studies and trials, or prepare or file regulatory related documents, in a timely
or competent fashion. The conduct of the clinical studies by, and the regulatory strategies of,
Myriad or these additional third parties, over which we have limited or no control, may delay or
prevent regulatory approval of our product candidates, which would delay or limit our ability to
generate revenue from product sales.
Risks Relating to Commercialization
We and our partner may not be able to successfully market and sell Ceplene®.
Even though Ceplene® was granted full marketing authorization by the European
Commission for the remission maintenance and prevention of relapse in adult patients with Acute
Myeloid Leukemia in first remission, our partner, Meda AB, may not be able to effectively market
and sell Ceplene®. We are reliant on Meda AB to generate revenue from sales of
Ceplene® in Europe and certain other countries on our behalf.
We expect to incur substantial net losses, in the aggregate and on a per share basis, for the
foreseeable future as Meda AB launches and commercializes Ceplene® and we seek FDA
approval to market Ceplene® in the United States. We are unable to predict the extent of
these future net losses, or when we may attain profitability, if at all. These net losses, among
other things, have had and will continue to have an adverse effect on our stockholders deficit. We
anticipate that for the foreseeable future our ability to generate revenues and achieve
profitability will be dependent on the successful commercialization of Ceplene®. If we
are unable to generate significant revenue from Ceplene®, or attain profitability, we
may not be able to sustain our operations.
Ceplene® may fail to achieve market acceptance, which could harm our business.
Even though Ceplene® was granted full marketing authorization by the European
Commission for the remission maintenance and prevention of relapse in adult patients with Acute
Myeloid Leukemia in first remission, physicians may choose not to prescribe this product, and
third-party payers may choose not to pay for it. Accordingly, we may be unable to generate
significant revenue or become profitable.
Acceptance of Ceplene® will depend on a number of factors including:
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acceptance of Ceplene® by physicians and patients as a safe and effective
treatment; |
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availability of reimbursement for our product from government or healthcare payors; |
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cost effectiveness of Ceplene®; |
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the effectiveness of our and Medas or collaboration partners sales and marketing
efforts; |
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relative convenience and ease of administration; |
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prevalence and severity of side effects; and |
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availability of competitive products. |
If Ceplene® fails to achieve market acceptance, our business, financial condition
and results of operations would be materially and adversely affected.
We are dependent upon collaborative arrangements for the further development and
commercialization of Ceplene®. These collaborative arrangements may place the
development and commercialization of Ceplene® outside of our control, may require us
to relinquish important rights or may otherwise be on terms unfavorable to us.
We have entered into a collaborative arrangement with Meda to market and sell
Ceplene® in Europe and certain other countries and we may enter into other
collaborations with third parties to further develop and commercialize Ceplene®. We may
not be able to enter into collaborative arrangements on attractive terms, on a timely basis or at
all. Dependence on collaborators for the development and commercialization of Ceplene®
subjects us to a number of risks, including:
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we may not be able to control the amount and timing of resources that our
collaborators devote to the development or commercialization of Ceplene® or to
their marketing and distribution, which could adversely affect our ability to obtain
milestone and royalty payments; |
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disputes may arise between us and our collaborators that result in the delay or
termination of the commercialization of our product candidates or that result in costly
litigation or arbitration that diverts managements attention and resources; |
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our collaborators may experience financial difficulties; |
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collaborators may not properly maintain or defend our intellectual property rights or
may use our proprietary information in such a way as to expose us to potential
litigation, jeopardize or lessen the value of our proprietary information, or weaken or
invalidate our intellectual property rights; |
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business combinations or significant changes in a collaborators business strategy may
also adversely affect a collaborators willingness or ability to complete its obligations
under any arrangement; |
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a collaborator could independently move forward with a competing product candidate
developed either independently or in collaboration with others, including our
competitors; and |
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the collaborations may be terminated or allowed to expire, which would delay product
development and commercialization efforts. |
If our arrangement with Meda is not successful or we are not able to enter into other
collaborative arrangements on commercially attractive terms, on a timely basis or at all, or if any
of the risks occur and we are unable to successfully manage such risks, our business, financial
condition and results of operations would be materially and adversely affected.
If we fail to enter into and maintain successful strategic alliances for our product candidates,
we may have to reduce or delay our product commercialization or increase our expenditures.
Our strategy for developing, manufacturing and commercializing potential product candidates in
multiple therapeutic areas currently requires us to enter into and successfully maintain strategic
alliances with pharmaceutical companies that have product development resources and expertise,
established distribution systems and direct sales forces to advance our development programs
and reduce our expenditures on each development program and market any products that we may
develop. We have formed a strategic alliance with Myriad with respect to the MX90745 series of
apoptosis-inducer anti-cancer compounds and with DURECT for our intellectual property for a
transdermal patch containing bupivacaine for the treatment of back pain. We may not be able to
negotiate additional strategic alliances on acceptable terms, or at all.
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We have entered into collaborative arrangements with respect to marketing or selling
Ceplene® in Europe, certain Pacific rim countries and Israel. We may rely on
collaborative partners to market and sell Ceplene® in other international markets We
cannot assure you that we will be able to enter into any more such arrangements on terms favorable
to us, or at all.
If we are unable to maintain our existing strategic alliances or establish and maintain
additional strategic alliances, we may have to limit the size or scope of, or delay, one or more of
our product development or commercialization programs, or undertake the various activities at our
own expense. In addition, our dependence on strategic alliances is subject to a number of risks,
including:
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the inability to control the amount or timing of resources that our collaborators may
devote to developing the product candidates; |
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the possibility that we may be required to relinquish important rights, including
intellectual property, marketing and distribution rights; |
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the receipt of lower revenues than if we were to commercialize such products
ourselves; |
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our failure to receive future milestone payments or royalties should a collaborator
fail to commercialize one of our product candidates successfully; |
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the possibility that a collaborator could separately move forward with a competing
product candidate developed either independently or in collaboration with others,
including our competitors; |
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the possibility that our collaborators may experience financial difficulties; |
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business combinations or significant changes in a collaborators business strategy
that may adversely affect that collaborators willingness or ability to complete its
obligations under any arrangement; and |
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the chance that our collaborators may operate in countries where their operations
could be negatively impacted by changes in the local regulatory environment or by
political unrest. |
If the market does not accept and use our product candidates, we will not achieve sufficient
product revenues and our business will suffer.
If we receive regulatory approval to market our product candidates, physicians, patients,
healthcare payors and the medical community may not accept and use them. The degree of market
acceptance and use of any approved products will depend on a number of factors, including:
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perceptions by members of the healthcare community, including physicians, about the
safety and effectiveness of our products; |
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cost effectiveness of our products relative to competing products; |
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relative convenience and ease of administration; |
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availability of reimbursement for our products from government or healthcare payors;
and |
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effectiveness of marketing and distribution efforts by us and our licensees and
distributors. |
Because we expect to rely on sales and royalties generated by our current lead product
candidates for a substantial portion of our product revenues for the foreseeable future, the
failure of any of these drugs to find market acceptance would harm our business and could require
us to seek additional funding to continue our other development programs.
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Our product candidates could be rendered obsolete by technological change and medical
advances, which would adversely affect the performance of our business.
Our product candidates may be rendered obsolete or uneconomical by the development of medical
advances to treat the conditions that our product candidates are designed to address. Pain
management therapeutics are the subject of active research and development by many potential
competitors, including major pharmaceutical companies, specialized biotechnology firms,
universities and other research institutions. Research and development by others may render our
technology or product candidates obsolete or noncompetitive or result in treatments or cures
superior to any therapy we developed. Technological advances affecting costs of production could
also harm our ability to cost-effectively produce and sell products.
We have no manufacturing capacity and anticipate continued reliance on third parties for the
manufacture of our product candidates.
We do not currently operate manufacturing facilities for Ceplene® or any of our
product candidates. We lack the resources and the capabilities to manufacture Ceplene®
or any of our product candidates. We currently rely on one or more contract manufacturers for
Ceplene® and each product candidate to supply, store and distribute drug supplies for
commercial use and for our clinical trials. Any performance failure or delay on the part of our
existing manufacturers could result in lost sales or delay clinical development or regulatory
approval of our product candidates and their commercialization, producing additional losses and
depriving us of potential product revenues.
If the FDA or other regulatory agencies approve any of our product candidates for commercial
sale, the product will need to be manufactured in larger quantities. Some of our product candidates
have been manufactured in only small quantities for preclinical and clinical trials. In those
cases, our third party manufacturers may not be able to successfully increase their manufacturing
capacity in a timely or economical manner, or at all. We may be forced to identify alternative or
additional third party manufacturers, which may prove difficult because the number of potential
manufacturers is limited and the FDA must approve any replacement contractor prior to manufacturing
our products. Such approval would require new testing and compliance inspections. In addition, a
new manufacturer would have to be educated in, or develop substantially equivalent processes for,
production of our product candidates. It may be difficult or impossible for us to find a
replacement manufacturer on acceptable terms quickly, or at all. If we are unable to successfully
increase the manufacturing capacity for a drug candidate in a timely and economical manner, the
regulatory approval or commercial launch of any related products may be delayed or there may be a
shortage in supply, both of which may have an adverse effect on our business.
Our product candidates require precise, high quality manufacturing. A failure to achieve and
maintain high manufacturing standards, including the incidence of manufacturing errors, could
result in patient injury or death, product recalls or withdrawals, delays or failures in product
testing or delivery, cost overruns or other problems that could seriously hurt our business.
Manufacturers often encounter difficulties involving production yields, quality control and quality
assurance, as well as shortages of qualified personnel. These manufacturers are subject to ongoing
periodic unannounced inspection by the FDA, the U.S. Drug Enforcement Agency and corresponding
state and foreign agencies to ensure strict compliance with current Good Manufacturing Practice and
other applicable government regulations and corresponding foreign standards; however, we do not
have control over third party manufacturers compliance with these regulations and standards. If
one of our manufacturers fails to maintain compliance, the production of our product candidates
could be interrupted, resulting in delays, additional costs and potentially lost revenues.
Additionally, third-party manufacturers must pass a pre-approval inspection before we can obtain
marketing approval for any of our products in development.
Furthermore, our existing and future contract manufacturers may not perform as agreed or may
not remain in the contract manufacturing business for the time required to successfully produce,
store and distribute our product candidates. We may not own, or may have to share, the intellectual
property rights to such innovation. In the event of a natural disaster, equipment failure, power
failure, strike or other difficulty, we may be unable to replace our third party manufacturers in a
timely manner.
We may be the subject of costly product liability claims or product recalls, and we may be unable
to obtain or maintain insurance adequate to cover potential liabilities.
The risk of product liability is inherent in the development, manufacturing and marketing of
human therapeutic products. Regardless of merit or eventual outcome, product liability claims may
result in:
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reduced revenues or a total withdrawal of a product from one or more markets; |
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delays in, or failure to complete, our clinical trials; |
25
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withdrawal of clinical trial participants; |
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decreased demand for our product candidates; |
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injury to our reputation; |
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substantial monetary awards against us; and |
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diversion of management or other resources from key aspects of our operations. |
Product liability claims could result in an FDA investigation of the safety or efficacy of our
products or our marketing programs. An FDA investigation could also potentially lead to a recall of
our products or more serious enforcement actions, or limitations on the indications for which our
products may be used, or suspension or withdrawal of approval.
We cannot be certain that the coverage limits of the insurance policies or those of our
strategic partners will be adequate. We further intend to expand our insurance coverage to include
the sale of commercial products if marketing approval is obtained for our product candidates. We
may not be able to obtain additional insurance or maintain our existing insurance coverage at a
reasonable cost or at all. If we are unable to obtain sufficient insurance at an acceptable cost or
if a claim is brought against us, whether fully covered by insurance or not, our business, results
of operations and financial condition could be materially adversely affected.
The coverage and reimbursement status of newly approved healthcare drugs is uncertain and failure
to obtain adequate coverage and reimbursement could limit our ability to market our products.
Our ability to commercialize any products successfully will depend in part on the extent to
which reimbursement will be available from governmental and other third-party payors, both in the
United States and in foreign markets. The amount reimbursed for our products may be insufficient to
allow them to compete effectively with products that are reimbursed at a higher level. If the price
we are able to charge for any product we develop is inadequate in light of our development costs,
our profitability would be reduced.
Reimbursement by a governmental and other third-party payor may depend upon a number of
factors, including the governmental and other third-party payors determination that the use of a
product is:
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a covered benefit under its health plan; |
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safe, effective and medically necessary; |
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appropriate for the specific patient; |
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neither experimental nor investigational. |
Obtaining reimbursement approval for a product from each third-party and governmental payor is
a time consuming and costly process that could require us to provide supporting scientific,
clinical and cost effectiveness data for the use of our products to each payor. We may not be able
to provide data sufficient to obtain reimbursement.
Eligibility for coverage does not imply that any drug product will be reimbursed in all cases
or at a rate that allows us to make a profit. Interim payments for new products, if applicable, may
also not be sufficient to cover our costs and may not become permanent. Reimbursement rates may
vary according to the use of the drug and the clinical setting in which it is used, may be based on
payments allowed for lower-cost drugs that are already reimbursed, may be incorporated into
existing payments for other products or services and may reflect budgetary constraints and/or
Medicare or Medicaid data used to calculate these rates. Net prices for products also may be
reduced by mandatory discounts or rebates required by government health care programs or by any
future relaxation of laws that restrict imports of certain medical products from countries where
they may be sold at lower prices than in the United States.
26
The health care industry is experiencing a trend toward containing or reducing costs through
various means, including lowering reimbursement rates, limiting therapeutic class coverage and
negotiating reduced payment schedules with service providers for drug products. There have been,
and we expect that there will continue to be, federal and state proposals to constrain expenditures
for medical products and services, which may affect reimbursement levels for our future products.
In addition, the Centers for Medicare and Medicaid Services frequently change product descriptors,
coverage policies, product and service codes, payment methodologies and reimbursement values.
Third-party payors often follow Medicare coverage policies and payment limitations in setting their
own reimbursement rates and may have sufficient market power to demand significant price
reductions.
Foreign governments tend to impose strict price controls, which may adversely affect our future
profitability.
In some foreign countries, particularly in the European Union, prescription drug pricing is
subject to governmental control. In these countries, pricing negotiations with governmental
authorities can take considerable time after the receipt of marketing approval for a product. To
obtain reimbursement or pricing approval in some countries, we may be required to conduct a
clinical trial that compares the cost-effectiveness of our product candidates to other available
therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if
pricing is set at unsatisfactory levels, our profitability would be reduced.
Risks Relating to Our Business and Industry
Our failure to attract and retain skilled personnel could impair our product development and
commercialization efforts.
Our success is substantially dependent on our continued ability to attract, retain and
motivate highly qualified management, scientific and technical personnel and our ability to develop
and maintain important relationships with leading institutions, clinicians and scientists. We are
highly dependent upon our key management personnel, particularly John V. Talley, our President and
Chief Executive Officer, Robert W. Cook, our Senior Vice President and Chief Financial Officer, Dr.
Stephane Allard, our Chief Medical Officer, Dr. Dileep Bhagwat, our Senior Vice President,
Pharmaceutical Development and Bernard Tyrrell, our Senior Vice President of Sales and Marketing.
We are also dependent on certain scientific and technical personnel. The loss of the services of
any member of senior management, or scientific or technical staff may significantly delay or
prevent the achievement of product development, commercialization and other business objectives.
Messrs. Talley and Cook have entered into employment agreements with us. However, either of them
may decide to voluntarily terminate his employment with us. We do not maintain key-man life
insurance on any of our employees.
We believe that we will need to recruit additional management and technical personnel. There
is currently a shortage of, and intense competition for, skilled executives and employees with
relevant scientific and technical expertise, and this shortage may continue. The inability to
attract and retain sufficient scientific, technical and managerial personnel could limit or delay
our product development efforts, which would reduce our ability to successfully commercialize
product candidates and our business.
Our competitors may develop and market drugs that are less expensive, safer, or more effective,
which may diminish or eliminate the commercial success of any of our product candidates.
The biotechnology and pharmaceutical industries are highly competitive and characterized by
rapid technological change. Because we anticipate that our research approach will integrate many
technologies, it may be difficult for us to stay abreast of the rapid changes in technology. If we
fail to stay at the forefront of technological change, we will be unable to compete effectively.
Our competitors may render our technologies obsolete by advances in existing technological
approaches or the development of different approaches by one or more of our current or future
competitors.
We will compete with Pfizer and Endo in the treatment of neuropathic pain. There are also many
companies, both publicly and privately held, including well-known pharmaceutical companies and
academic and other research institutions, engaged in developing pharmaceutical products for the
treatment of life-threatening cancers and diseases.
Our competitors may:
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develop and market product candidates that are less expensive and more effective than
our future product candidates; |
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adapt more quickly to new technologies and scientific advances; |
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commercialize competing product candidates before we or our partners can launch any
product candidates developed from our product candidates; |
27
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initiate or withstand substantial price competition more successfully than we can; |
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have greater success in recruiting skilled scientific workers from the limited pool
of available talent; |
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more effectively negotiate third-party licenses and strategic alliances; and |
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take advantage of acquisition or other opportunities more readily than we can. |
We will compete for market share against fully-integrated pharmaceutical companies and smaller
companies that are collaborating with larger pharmaceutical companies, new companies, academic
institutions, government agencies and other public and private research organizations. Many of
these competitors, either alone or together with their partners, may develop new product candidates
that will compete with our product candidates, as these competitors may operate larger research and
development programs or have substantially greater financial resources than us. Our competitors may
also have significantly greater experience in:
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developing drugs; |
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undertaking preclinical testing and human clinical trials; |
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building relationships with key customers and opinion-leading physicians; |
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obtaining and maintaining FDA and other regulatory approvals of drugs; |
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formulating and manufacturing drugs; and |
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launching, marketing and selling drugs. |
These and other competitive factors may negatively impact our financial performance.
EpiCept GmbH, our German subsidiary, is subject to various risks associated with its international
operations.
Our subsidiary, EpiCept GmbH, operates in Germany, and we face a number of risks associated
with its operations, including:
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difficulties and costs associated in complying with German laws and regulations; |
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changes in the German regulatory environment; |
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increased costs associated with operating in Germany; |
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increased costs and complexities associated with financial reporting; and |
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difficulties in maintaining international operations. |
Expenses incurred by our German operations are typically denominated in euros. In addition,
EpiCept GmbH has incurred indebtedness that is denominated in euros and requires that interest be
paid in euros. As a result, our costs of maintaining and operating our German subsidiary, and the
interest payments and costs of repaying its indebtedness, increase if the value of the U.S. dollar
relative to the euro declines.
Risks Relating to Intellectual Property
If we are unable to protect our intellectual property, our competitors could develop and market
products with features similar to our products and demand for our products may decline.
Our commercial success will depend in part on obtaining and maintaining patent protection and
trade secret protection of our technologies and product candidates as well as successfully
defending these patents and trade secrets against third party challenges.
We will only be able to protect our intellectual property from unauthorized use by third
parties to the extent that valid and enforceable patents or trade secrets cover them.
28
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
involve complex legal and factual questions for which important legal principles remain unresolved.
In addition, changes in either the patent laws or in interpretations of patent laws in the United
States or other countries may diminish the value of our intellectual property. Accordingly, we
cannot predict the breadth of claims that may be allowed or enforced in our patents or in third
party patents.
The degree of future protection for our proprietary rights is uncertain because legal means
afford only limited protection and may not adequately protect our rights or permit us to gain or
keep our competitive advantage. For example:
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we might not have been the first to make the inventions covered by each of its
pending patent applications and issued patents, and we could lose our patent rights as a
result; |
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we might not have been the first to file patent applications for these inventions or
our patent applications may not have been timely filed, and we could lose our patent
rights as a result; |
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others may independently develop similar or alternative technologies or duplicate any
of our technologies; |
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it is possible that none of our pending patent applications will result in issued
patents; |
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our issued patents may not provide a basis for commercially viable drugs or
therapies, may not provide us with any protection from unauthorized use of our
intellectual property by third parties, and may not provide us with any competitive
advantages; |
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our patent applications or patents may be subject to interference, opposition or
similar administrative proceedings; |
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we may not develop additional proprietary technologies that are patentable; or |
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the patents of others may have an adverse effect on our business. |
Moreover, the issuance of a patent is not conclusive as to its validity or enforceability and
it is uncertain how much protection, if any, will be afforded by our patents if we attempt to
enforce them and they are challenged in court or in other proceedings, such as oppositions, which
may be brought in U.S. or foreign jurisdictions to challenge the validity of a patent. A third
party may challenge the validity or enforceability of a patent after its issuance by the U.S.
Patent and Trademark Office, or USPTO.
The defense and prosecution of intellectual property suits, interferences, oppositions and
related legal and administrative proceedings in the United States are costly, time consuming to
pursue and result in diversion of resources. The outcome of these proceedings is uncertain and
could significantly harm our business.
We will also rely on trade secrets to protect our technology, especially where we do not
believe patent protection is appropriate or obtainable. However, trade secrets are difficult to
protect. We will use reasonable efforts to protect our trade secrets, our employees, consultants,
contractors, outside scientific partners and other advisors may unintentionally or willfully
disclose its confidential information to competitors. Enforcing a claim that a third party
improperly obtained and is using our trade secrets is expensive and time consuming, and the outcome
is unpredictable. In addition, courts outside the United States are sometimes less willing to
protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge,
methods and know-how.
If we are not able to defend the patent protection position of our technologies and product
candidates, then we will not be able to exclude competitors from marketing product candidates that
directly compete with our product candidates, and we may not generate enough revenue from our
product candidates to justify the cost of their development and to achieve or maintain
profitability.
If we are sued for infringing intellectual property rights of third parties, such litigation will
be costly and time consuming, and an unfavorable outcome could increase our costs or have a
negative impact on our business.
Our ability to commercialize our products depends on our ability to sell our products without
infringing the proprietary rights of third parties. Numerous U.S. and foreign issued patents and
pending applications, which are owned by third parties, exist with respect to the therapeutics
utilized in our product candidates and topical delivery mechanisms. Because we are utilizing
existing therapeutics, we will continue to need to ensure that we can utilize these therapeutics
without infringing existing patent rights.
Accordingly, we have reviewed related patents known to us and, in some instances, licensed
related patented technologies. In addition, because patent applications can take several years to
issue, there may be currently pending applications, unknown to us, which may later result in issued
patents that the combined organizations product candidates may infringe. There could also be
existing patents of which we are not aware that our product candidates may inadvertently infringe.
29
We cannot assure you that any of our product candidates does not infringe the intellectual
property of others. There is a substantial amount of litigation involving patent and other
intellectual property rights in the biotechnology and biopharmaceutical industries generally. If a
third party claims that we infringe on their technology, we could face a number of issues that
could increase its costs or have a negative impact on its business, including:
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infringement and other intellectual property claims which, with or without merit, can
be costly and time consuming to litigate and can delay the regulatory approval process
and divert managements attention from our core business strategy; |
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substantial damages for past infringement, which we may have to pay if a court
determines that our products infringes a competitors patent; |
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an injunction prohibiting us from selling or licensing our product unless the patent
holder licenses the patent to us, which the holder is not required to do; and |
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if a license is available from a patent holder, we may have to pay substantial
royalties or grant cross licenses to our patents. |
We may be subject to damages resulting from claims that our employees have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at other biotechnology or pharmaceutical
companies, including competitors or potential competitors. We may be subject to claims that we or
these employees have inadvertently or otherwise used or disclosed trade secrets or other
proprietary information of their former employers. Litigation may be necessary to defend against
these claims. If we fail in defending such claims, in addition to paying monetary claims, we may
lose valuable intellectual property rights or personnel. A loss of key research personnel or their
work product could hamper or prevent our ability to commercialize certain product candidates, which
could severely harm our business. Litigation could result in substantial costs and be a distraction
to management.
Risks Relating to our Common Stock
We expect that our stock price will fluctuate significantly due to external factors, which could
cause the value of your investment to decline.
Securities markets worldwide have experienced, and are likely to continue to experience,
significant price and volume fluctuations. This market volatility, as well as general economic,
market or political conditions, could reduce the market price of our common stock regardless of our
operating performance.
Since January 30, 2007, our common stock trades on The Nasdaq Capital Market and on the Nasdaq
OMX Stockholm Exchange. From January 5, 2006 through January 29, 2007, our common stock traded on
The Nasdaq National Market. Prior to January 4, 2006, our common stock did not trade on an
exchange. Sales of substantial amounts of our common stock in the public market through our $15
Million At-the-Market Program or otherwise could adversely affect the prevailing market prices of
the common stock and our ability to raise equity capital in the future. In particular, as of March
5, 2010 we have outstanding warrants to purchase approximately 12.5 million shares of our common
stock, and the market price of our common stock could decline as a result of exercises or sales by
our existing warrant holders in the market or the perception that these exercises or sales could
occur. These exercises or sales might also make it more difficult for us to sell equity securities
at a time and price that we deem appropriate.
If securities or industry analysts do not publish research or reports about us, if they change
their recommendations regarding our stock adversely or if our operating results do not meet their
expectations, our stock price and trading volume could decline.
The trading market for our common stock is influenced by the research and reports that
industry or securities analysts publish about us. If one or more of these analysts cease coverage
of us or fail to regularly publish reports on us, we could lose visibility in the financial
markets, which in turn could cause our stock price or trading volume to decline. Moreover, if one
or more of the analysts who covers us downgrades our stock or if our operating results do not meet
their expectations, our stock price could decline.
30
Future sales of common stock may cause our stock price to fall.
As of March 5, 2010, we have outstanding and exercisable warrants to purchase approximately
2.3 million shares of our common stock with an exercise price of $1.17 $2.08. We also have a
significant number of warrants outstanding with exercise prices ranging from $2.58 $5.64 that are
currently exercisable. The market price of our common stock could decline as a result of exercises
or sales by our existing warrant holders and stockholders in the market or the perception that
these exercises or sales could occur. These sales might also make it more difficult for us to sell
equity securities or convertible debt securities at a time and price that we deem appropriate.
In February 2010, we established an At-the-Market offering program through which we may,
from time to time, offer and sell shares of our common stock having an aggregate offering price of
up to $15.0 million from time to time through our sales agent. Sales of the shares, if any, will
be made by means of ordinary brokers transactions on The Nasdaq Capital Market or, to the extent
allowable by law, the Nasdaq OMX Stockholm Exchange, at market prices. Additionally, under the
terms of the sales agreement, we may also sell shares of our common stock through the sales agent
on The Nasdaq Capital Market or, to the extent allowable by law, the Nasdaq OMX Stockholm Exchange,
or otherwise, at negotiated prices or at prices related to the prevailing market price. We will
designate the maximum amount of shares of common stock to be sold on a daily basis as we and our
sales agent may agree. While we plan to utilize this program at such times and in such amounts so
as to minimize disruption to the trading of our stock, our utilization of this program may have a
negative impact on the price of our common stock.
Provisions of our charter documents or Delaware law could delay or prevent an acquisition of us,
even if the acquisition would be beneficial to our stockholders, and could make it more difficult
for you to change management.
Provisions of our certificate of incorporation and bylaws may discourage, delay or prevent a
merger, acquisition or other change in control that stockholders may consider favorable, including
transactions in which stockholders might otherwise receive a premium for their shares. This is
because these provisions may prevent or frustrate attempts by stockholders to replace or remove our
management. These provisions include:
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a classified board of directors; |
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a prohibition on stockholder action through written consent; |
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a requirement that special meetings of stockholders be called only by the board of
directors or a committee duly designated by the board of directors whose powers and
authorities include the power to call such special meetings; |
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advance notice requirements for stockholder proposals and nominations; and |
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the authority of the board of directors to issue preferred stock with such terms as
the board of directors may determine. |
In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly held
Delaware corporation from engaging in a business combination with an interested stockholder,
generally a person that together with its affiliates owns or within the last three years has owned
15% of voting stock, for a period of three years after the date of the transaction in which the
person became an interested stockholder, unless the business combination is approved in a
prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of
us.
As a result of these provisions in our charter documents and Delaware law, the price investors
may be willing to pay in the future for shares of our common stock may be limited.
31
We have never paid dividends on our capital stock, and we do not anticipate paying any cash
dividends in the foreseeable future.
We have never paid cash dividends on any of our classes of capital stock to date, and we
intend to retain our future earnings, if any, to fund the development and growth of our business.
In addition, the terms of existing or any future debt may preclude us from
paying these dividends. As a result, capital appreciation, if any, of our common stock will be
your sole source of gain for the foreseeable future.
The requirements of being a public company may strain our resources and distract management.
As a public company, we are subject to the reporting requirements of the Exchange Act, the
Sarbanes-Oxley Act and the listing requirements of The Nasdaq Capital Market and the Nasdaq OMX
Stockholm Exchange. The obligations of being a public company require significant additional
expenditures and place additional demands on our management as we comply with the reporting
requirements of a public company. We may need to hire additional accounting and financial staff
with appropriate public company experience and technical accounting knowledge.
32
ITEM 1B. UNRESOLVED STAFF COMMENTS
We have no written comments regarding our periodic or current reports from the staff of the
Securities and Exchange Commission that were issued 180 days or more
preceding the end of our 2009
fiscal year that remain unresolved.
ITEM 2. PROPERTIES
EpiCept leases approximately 10,000 square feet located at 777 Old Saw Mill River Road,
Tarrytown, NY until February 2012. EpiCept also leases
approximately 3,000 square feet in Munich,
Germany until July 2010, with an automatic extension
for an additional year. EpiCept
currently leases approximately 23,500 rentable square feet of laboratory and office space in San
Diego, California that it is attempting to sublease. We believe that our existing facilities will
be adequate to accommodate our business needs.
ITEM 3. LEGAL PROCEEDINGS
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
33
PART II
ITEM 5. MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
Price Range of Common Stock
Our common stock is traded on both The Nasdaq Capital Market and the Nasdaq OMX Stockholm Exchange
under the symbol EPCT. The following table sets forth the range of high and low sales prices per
share for the common stock as reported on The Nasdaq Capital Market during the periods indicated.
For ease of comparison, all of the prices in the following table have been adjusted to reflect the
1:3 reverse split of our common stock, which was effective for the start of trading on January 15,
2010, as if such reverse split had been in effect during the periods indicated. Prior to January
4, 2006, all of our common stock, par value $.0001 per share, was privately held. We have never
declared or paid dividends on our common stock and we do not anticipate paying any cash dividends
on our capital stock in the foreseeable future. We currently intend to retain all available funds
and any future earnings to fund the development and growth of our business.
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Price Range |
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High |
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Low |
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For Year Ended December 31, 2009 |
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First Quarter |
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$ |
2.82 |
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$ |
1.26 |
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Second Quarter |
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3.75 |
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1.29 |
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Third Quarter |
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3.06 |
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1.68 |
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Fourth Quarter |
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2.73 |
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1.68 |
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Price Range |
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High |
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Low |
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For Year Ended December 31, 2008 |
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First Quarter |
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$ |
4.77 |
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$ |
1.50 |
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Second Quarter |
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1.86 |
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0.72 |
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Third Quarter |
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3.03 |
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0.66 |
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Fourth Quarter |
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2.94 |
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1.32 |
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The high and low sales prices for the Common Stock during the first quarter of 2010 (through
March 5, 2010) were $2.73 and $1.74 respectively. The closing price on March 5, 2010 was $2.02.
34
Performance Graph
The following graph and table compare the cumulative total return of our common stock, the
Nasdaq Biotechnology Index and the AMEX Biotechnology Index, as described below, for the period
beginning January 4, 2006 (the date we became a public company) and ending December 31, 2009,
assuming an initial investment of $100 and the reinvestment of any dividends. We obtained the
information reflected in the graph and table from independent sources we believe to be reliable,
but we have not independently verified the information.
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Total Return |
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Name |
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January 5, 2006 |
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December 31, 2009 |
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EpiCept |
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100 |
% |
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6.82 |
% |
NYSE Arca Biotechnology Index |
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100 |
% |
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100.76 |
% |
Nasdaq Biotechnology Index |
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100 |
% |
|
|
105.99 |
% |
Performance Graph and related information shall not be deemed soliciting material or to be
filed with the Securities and Exchange Commission, nor shall such information be incorporated by
reference into any future filing under the Securities Act or Exchange Act, each as amended, except
to the extent that we specifically incorporate it by reference into such filing.
35
ITEM 6. SELECTED FINANCIAL DATA
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
2006(1) |
|
|
2005 |
|
|
|
(Dollars in thousands, except share and per share data) |
|
Consolidated Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
414 |
|
|
$ |
265 |
|
|
$ |
327 |
|
|
$ |
2,095 |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
7,548 |
|
|
|
9,599 |
|
|
|
11,759 |
|
|
|
14,242 |
|
|
|
5,783 |
(5) |
Research and development |
|
|
11,603 |
|
|
|
12,623 |
|
|
|
15,312 |
|
|
|
15,675 |
|
|
|
1,846 |
|
Acquired in-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
19,151 |
|
|
|
22,222 |
|
|
|
27,071 |
|
|
|
63,279 |
|
|
|
7,629 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(18,737 |
) |
|
|
(21,957 |
) |
|
|
(26,744 |
) |
|
|
(61,184 |
) |
|
|
(6,801 |
) |
Other expense, net |
|
|
(20,073 |
)(7) |
|
|
(3,422 |
) |
|
|
(1,945 |
) |
|
|
(4,269 |
) |
|
|
(698 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before (expense)/benefit for income taxes |
|
|
(38,810 |
) |
|
|
(25,379 |
) |
|
|
(28,689 |
) |
|
|
(65,453 |
) |
|
|
(7,499 |
) |
Income tax (expense)/benefit |
|
|
(4 |
) |
|
|
(3 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(38,814 |
) |
|
|
(25,382 |
) |
|
|
(28,693 |
) |
|
|
(65,453 |
) |
|
|
(7,215 |
) |
Deemed dividend and redeemable convertible
preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,963 |
) |
|
|
(1,254 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss attributable to common stockholders |
|
$ |
(38,814 |
) |
|
$ |
(25,382 |
) |
|
$ |
(28,693 |
) |
|
$ |
(74,416 |
) |
|
$ |
(8,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share(2) |
|
$ |
(0.97 |
) |
|
$ |
(1.23 |
) |
|
$ |
(2.37 |
) |
|
$ |
(9.21 |
) |
|
$ |
(14.85 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding(2) |
|
|
40,139,299 |
|
|
|
20,685,710 |
|
|
|
12,129,258 |
|
|
|
8,077,625 |
|
|
|
570,102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
2006(1) |
|
|
2005 |
|
|
|
(Dollars in thousands) |
|
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,142 |
|
|
$ |
790 |
|
|
$ |
4,943 |
|
|
$ |
14,097 |
|
|
$ |
403 |
|
Working capital (deficit) |
|
|
1,407 |
|
|
|
(8,535 |
) |
|
|
(8,208 |
)(3) |
|
|
(4,481 |
)(3) |
|
|
(19,735 |
)(6) |
Total assets |
|
|
7,514 |
|
|
|
2,271 |
|
|
|
7,398 |
|
|
|
18,426 |
|
|
|
2,747 |
|
Long-term debt |
|
|
967 |
|
|
|
277 |
|
|
|
375 |
|
|
|
447 |
|
|
|
4,705 |
|
Redeemable convertible preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,608 |
|
Accumulated deficit |
|
|
(235,045 |
) |
|
|
(196,231 |
) |
|
|
(170,849 |
) |
|
|
(142,156 |
)(4) |
|
|
(67,740 |
) |
Total stockholders deficit |
|
|
(9,079 |
) |
|
|
(17,730 |
) |
|
|
(14,177 |
) |
|
|
(9,373 |
) |
|
|
(60,122 |
) |
|
|
|
(1) |
|
On January 4, 2006, we completed our merger with Maxim Pharmaceuticals, Inc. |
|
(2) |
|
On January 4, 2006, there was a one-for-four reverse stock split and on January 14, 2010
there was a one-for-three reverse stock split. All prior periods have been retroactively
adjusted to reflect the reverse stock splits. |
|
(3) |
|
Our debt owed to Hercules of $7.3 million and $10.0 million at December 31, 2007 and 2006,
respectively, which matured on April 1, 2009 contained a subjective acceleration clause and
accordingly was classified as a current liability in accordance with Financial Accounting
Standard Board, or FASB, Technical Bulletin 79-3 Subjective Acceleration Clauses in Long-Term
Debt Agreements. |
|
(4) |
|
Includes the in-process research and development of $33.4 million acquired upon the
completion of our merger with Maxim Pharmaceuticals, Inc. on January 4, 2006 and the
beneficial conversion features of $8.6 million related to the conversion of certain of our
notes outstanding and preferred stock into our common stock and from certain anti-dilution
adjustments to our preferred stock as a result of the exercise of the bridge warrants. |
|
(5) |
|
Includes $1.7 million write off of initial public offering costs. |
|
(6) |
|
As of December 31, 2005, debt of approximately $11.5 million was due within 12 months and as
a result it was classified as a current liability. |
|
(7) |
|
Amortization of debt issuance costs and discount and interest expense were both accelerated
in 2009 as a result of the conversion of $24.5 million of our 7.5556% convertible subordinated
notes due 2014 into approximately 9.1 million shares of our common stock in 2009. Interest
expense for the year ended December 31, 2009 included $10.5 million in amortization of debt
issuance costs and discount and $9.3 million in interest expense paid from escrowed cash that
represented the make-whole interest payment that would have been due at maturity of such
notes. |
36
ITEM 7. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion of our financial condition and results of operations
in conjunction with our consolidated financial statements and the related notes included elsewhere
in this report. This discussion contains forward-looking statements that involve risks and
uncertainties. As a result of many factors, including those set forth under the section entitled
Risk Factors and elsewhere in this report, our actual results may differ materially from those
anticipated in these forward-looking statements.
Overview
We are a specialty pharmaceutical company focused on the clinical development and
commercialization of pharmaceutical products for the treatment of cancer and pain. We focus our
clinical development efforts on innovative cancer therapies and topically delivered analgesics
targeting peripheral nerve receptors. Our lead product is Ceplene®, which when used
concomitantly with low-dose interleukin-2 is intended as remission maintenance therapy in the
treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete
remission. In October 2008, the European Commission issued a formal marketing authorization for
Ceplene® in the European Union, or EU. In November 2009, Health Canada accepted for
review a New Drug Submission, or NDS, for Ceplene® for the treatment of AML in Canada.
We are continuing our preparation of a New Drug Application, or NDA, filing with the United States
Food and Drug Administration, or FDA for Ceplene® in the same indication. In addition
to Ceplene®, we have two oncology compounds and a pain product candidate for the
treatment of peripheral neuropathies in clinical development. We believe this portfolio of
oncology and pain management product candidates lessens our reliance on the success of any single
product or product candidate.
Our cancer portfolio includes crinobulin, a novel small molecule vascular disruption agent, or
VDA, and apoptosis inducer for the treatment of patients with solid tumors. We have completed our
first Phase I clinical trial for crinobulin. AzixaTM, or MPC-6827, an apoptosis inducer
with VDA activity licensed by us to Myriad Pharmaceuticals, Inc., or Myriad, as part of an
exclusive, worldwide development and commercialization agreement, is currently in Phase II clinical
trials in patients with primary glioblastoma, melanoma that has metastasized to the brain and
non-small-cell lung cancer that has spread to the brain.
Our late-stage pain product candidate, EpiCeptTM NP-1 cream, which we refer to as
NP-1, is a prescription topical analgesic cream designed to provide effective long-term relief of
pain associated with peripheral neuropathies. In January 2009, we concluded a Phase II clinical
trial of NP-1 in which we studied its safety and efficacy in patients suffering from post-herpetic
neuralgia, or PHN, compared to gabapentin and placebo. This trial met its primary endpoints. In
February 2008, we concluded a Phase II clinical study of NP-1 in patients suffering from diabetic
peripheral neuropathy, or DPN. Both studies support the advancement of NP-1 into a
registration-sized trial. NP-1 utilizes a proprietary formulation to administer FDA approved pain
management therapeutics, or analgesics, directly on the skins surface at or near the site of the
pain, targeting pain that is influenced, or mediated, by nerve receptors located just beneath the
skins surface.
We are subject to a number of risks associated with companies in the specialty pharmaceutical
industry. Principal among these are risks associated with our ability to obtain regulatory approval
for our product candidates, our ability to adequately fund our operations, dependence on
collaborative arrangements, the development by us or our competitors of new technological
innovations, dependence on key personnel, protection of proprietary technology and compliance with
the FDA and other governmental regulations. We have yet to generate meaningful product revenues
from any of our product candidates. We have financed our operations primarily through the proceeds
from the sale of common stock, warrants, debt instruments, cash proceeds from collaborative
relationships and investment income earned on cash balances and short-term investments.
Ceplene® has been granted full marketing authorization by the European Commission
for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid
Leukemia in first remission. None of our other drug candidates has received FDA or foreign
regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory
agencies must conclude that our clinical data and that of our collaborators establish the safety
and efficacy of our drug candidates. Furthermore, our strategy includes entering into collaborative
arrangements with third parties to participate in the development and commercialization of our
products. In the event that third parties have control over the preclinical development or clinical
trial process for a product candidate, the estimated completion date would largely be under control
of that third party rather than under our control. We cannot forecast with any degree of certainty
which of our drug candidates will be subject to future collaborations or how such arrangements
would affect our development plan or capital requirements.
37
We have prepared our consolidated financial statements under the assumption that we are a
going concern. We have devoted substantially all of our cash resources to research and development
programs and general and administrative expenses, and to date we have not generated any meaningful
revenues from the sale of products. Since inception, we have incurred significant net losses
each year. As a result, we have an accumulated deficit of $235.0 million as of December 31,
2009. Our recurring losses from operations and the accumulated deficit raise substantial doubt
about our ability to continue as a going concern. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty. Our losses have resulted
principally from costs incurred in connection with our development activities and from general and
administrative expenses. Even if we succeed in developing and commercializing one or more of our
product candidates, we may never become profitable. We expect to continue to incur significant
expenses over the next several years as we:
|
|
|
Commence pre-marketing activities related to the anticipated launches of
Ceplene® in North America; |
|
|
|
apply for marketing approval in the U.S., Canada, and other countries; |
|
|
|
continue to conduct clinical trials for our product candidates; |
|
|
|
seek regulatory approvals for our product candidates; |
|
|
|
develop, formulate, and commercialize our product candidates; |
|
|
|
implement additional internal systems and develop new infrastructure; |
|
|
|
acquire or in-licenses additional products or technologies or expand the use of our
technologies; |
|
|
|
maintain, defend and expand the scope of our intellectual property; and |
|
|
|
hire additional personnel. |
Cash at December 31, 2009 plus $3 million cash received from Meda AB in connection with the
signing of the Ceplene® European marketing and distribution agreement will be sufficient
to fund our operations and meet debt service into the third quarter 2010. To conserve cash, we may
delay or cancel some of our planned development activities that are not related to
Ceplene® during 2010.
We have two wholly-owned subsidiaries, Maxim, based in San Diego, California, which is
currently inactive, and EpiCept GmbH, based in Munich, Germany, which is engaged in commercial
activities on our behalf. In January 2009, we discontinued our drug discovery activities at our
facility in San Diego.
Reverse Split of Common Stock
On January 14, 2010, we effected a previously authorized 1-for-3 reverse stock split of our
common stock. The reverse stock split took effect at the start of trading on January 15, 2010 on a
1-for-3 split-adjusted basis. All prior periods have been retroactively adjusted to reflect the
reverse stock split.
The Nasdaq Capital Market Listing
On February 2, 2010, Nasdaq Listing Qualifications Department notified us that we have
regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) and met the
requirements of the Nasdaq Listing Qualification Panel (the Panel) decision dated November 2,
2009. Accordingly, the Panel has determined to continue the listing of our common stock on The
Nasdaq Stock Market. The Panel had previously determined to continue our listing subject to the
condition that, on or before February 1, 2010, we evidence a closing bid price of $1.00 per share
or more for at least the ten prior consecutive trading days. On January 29, 2010, our closing bid
price was $2.37 per share, the tenth consecutive day it had exceeded the $1.00 per share threshold.
Accordingly, we satisfied the Panels condition and the delisting proceeding is now closed.
Recent Events
None.
Off Balance Sheet Arrangements
We do not have any relationships with unconsolidated entities or financial partnerships, such
as entities often referred to as structured finance or special purpose entities, which would have
been established for the purpose of facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes. In addition, we do not engage in trading activities
involving non-exchange traded contracts. Therefore, we are not materially exposed to any financing,
liquidity, market or credit risk that could arise if we had engaged in these relationships. We do
not have relationships or transactions with persons or entities that derive benefits from their
non-independent relationship with us or our related parties.
38
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on
our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these financial statements
requires that we make estimates and judgments affecting the reported amounts of assets, liabilities
and expenses and related disclosure of contingent assets and liabilities. We review our estimates
on an ongoing basis. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable under the circumstances. Actual results may differ
from these estimates under different assumptions or conditions. While our significant accounting
policies are described in more detail in the notes to our consolidated financial statements
included in this annual report, we believe the following accounting policies to be critical to the
judgments and estimates used in the preparation of our consolidated financial statements.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements. Estimates also affect the reported amounts of
revenues and expenses during the reporting period, stock-based compensation and warrant liability.
Actual results could differ from those estimates.
Revenue Recognition
We recognize revenue relating to our collaboration agreements in accordance with the SEC Staff
Accounting Bulletin (SAB) 104, Revenue Recognition, and FASB Accounting Standards Codification
(ASC) 605-25, Revenue Recognition Multiple Element Arrangements (ASC 605-25). Revenue
under collaborative arrangements may result from license fees, milestone payments, research and
development payments and royalties.
Our application of these standards involves subjective determinations and requires management
to make judgments about value of the individual elements and whether they are separable from the
other aspects of the contractual relationship. We evaluate our collaboration agreements to
determine units of accounting for revenue recognition purposes. For collaborations containing a
single unit of accounting, we recognize revenue when the fee is fixed or determinable,
collectibility is assured and the contractual obligations have occurred or been rendered. For
collaborations involving multiple elements, our application requires management to make judgments
about value of the individual elements and whether they are separable from the other aspects of the
contractual relationship. To date, we have determined that our upfront non-refundable license fees
cannot be separated from our ongoing collaborative research and development activities to the
extent such activities are required under the agreement and, accordingly, do not treat them as a
separate element. We recognize revenue from non-refundable, up-front licenses and related payments,
not specifically tied to a separate earnings process, either on the proportional performance method
with respect to our license with Endo, or ratably over either the development period or the later
of (1) the conclusion of the royalty term on a jurisdiction by jurisdiction basis; and (2) the
expiration of the last EpiCept licensed patent as we do with respect to our license with DURECT,
Myriad and GNI, Ltd., or GNI.
Proportional performance is measured based on costs incurred compared to total estimated costs
over the development period which approximates the proportion of the value of the services provided
compared to the total estimated value over the development period. The proportional performance
method currently results in revenue recognition at a slower pace than the ratable method as many of
our costs are incurred in the latter stages of the development period. We periodically review our
estimates of cost and the length of the development period and, to the extent such estimates
change, the impact of the change is recorded at that time. During each of the years 2009 and 2008
we increased the estimated development period by an additional twelve months to reflect additional
time required to obtain clinical data from our partner.
We will recognize milestone payments as revenue upon achievement of the milestone only if (1)
it represents a separate unit of accounting as defined in ASC 605-25; (2) the milestone payments
are nonrefundable; (3) substantive effort is involved in achieving the milestone; and (4) the
amount of the milestone is reasonable in relation to the effort expended or the risk associated
with the achievement of the milestone. If any of these conditions are not met, we will recognize
milestones as revenue in accordance with our accounting policy in effect for the respective
contract. At the time of a milestone payment receipt, we will recognize revenue based upon the
portion of the development services that are completed to date and defer the remaining portion and
recognize it over the remainder of the development services on the proportional or ratable method,
whichever is applicable. When payments are specifically tied to a separate earnings process,
revenue will be recognized when the specific performance obligation associated with the payment has
been satisfied. Deferred revenue represents the excess of cash received compared to revenue
recognized to date under licensing agreements.
39
Royalty Expense
Upon receipt of marketing approval and commencement of commercial sales, some of which may not
occur for several years, we will owe royalties to licensors of certain patents generally based upon
net sales of the respective products. Under a license agreement with respect to NP-1, we are
obligated to pay royalties based on annual net sales derived from the products incorporating the
licensed technology. Under a license agreement with respect to crinobulin, we are required to
provide a portion of any sublicensing payments we receive if we relicense the series of compounds
or make milestone payments, assuming the successful commercialization of the compound by us for the
treatment of a cancer indication, as well as pay a royalty on product sales. Under a royalty
agreement with respect to Ceplene®, we are obligated to pay royalties based on annual
net sales derived from the products incorporating the licensed technology. In each case, our
royalty obligation ends the later of (1) the conclusion of the royalty term on a jurisdiction by
jurisdiction basis; and (2) the expiration of the last EpiCept licensed patent.
Stock-Based Compensation
We record stock-based compensation expense at fair value in accordance with the Financial
Accounting Standards Board, or FASB, issued ASC 718-10, Compensation Stock Compensation (ASC
718-10). We utilize the Black-Scholes valuation method to recognize compensation expense over the
vesting period. Certain assumptions need to be made with respect to utilizing the Black-Scholes
valuation model, including the expected life, volatility, risk-free interest rate and anticipated
forfeiture of the stock options. The expected life of the stock options was calculated using the
method allowed by the provisions of ASC 718-10. In accordance with ASC 718-10, the simplified
method for plain vanilla options may be used where the expected term is equal to the vesting term
plus the original contract term divided by two. The risk-free interest rate is based on the rates
paid on securities issued by the U.S. Treasury with a term approximating the expected life of the
options. Estimates of pre-vesting option forfeitures are based on our experience. We will adjust
our estimate of forfeitures over the requisite service period based on the extent to which actual
forfeitures differ, or are expected to differ, from such estimates. Changes in estimated
forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and
will also impact the amount of compensation expense to be recognized in future periods.
We account for stock-based transactions with non-employees in which services are received in
exchange for the equity instruments based upon the fair value of the equity instruments issued, in
accordance with ASC 718-10 and ASC 505-50, Equity-Based Payments to Non-Employees. The two
factors that most affect charges or credits to operations related to stock-based compensation are
the estimated fair market value of the common stock underlying stock options for which stock-based
compensation is recorded and the estimated volatility of such fair market value. The value of such
options is periodically remeasured and income or expense is recognized during the vesting terms.
Accounting for stock-based compensation granted by us requires fair value estimates of the
equity instrument granted or sold. If our estimate of the fair value of stock-based compensation is
too high or too low, it will have the effect of overstating or understating expenses. When
stock-based grants are granted in exchange for the receipt of goods or services, we estimate the
value of the stock-based compensation based upon the value of our common stock.
During each of the years 2009 and 2008, we issued approximately 0.7 million stock options,
with varying vesting provisions to certain of our employees and directors. Based on the
Black-Scholes valuation method (volatility 110.0% -118.0%, risk free rate 1.67% 2.52%,
dividends zero, weighted average life 5 years; forfeiture 10%), for the grants issued in
2009, we estimated $1.0 million of share-based compensation will be recognized as compensation
expense over the vesting period, which will be amortized over the weighted average remaining
requisite service period of 2.5 years. During years 2009 and 2008, we recognized total share-based
compensation of approximately $1.4 million and $2.2 million, related to the options granted during
2009, 2008, 2007, 2006 and the unvested outstanding Maxim options as of January 4, 2006 that were
converted into EpiCept options based on the vesting of those options during 2006. Future grants of
options will result in additional charges for stock-based compensation that will be recognized over
the vesting periods of the respective options.
Derivatives
As a result of certain financings, derivative instruments were created that we have measured
at fair value and mark to market at each reporting period. Fair value of the derivative instruments
will be affected by estimates of various factors that may affect the respective instrument,
including our cost of capital, the risk free rate of return, volatility in the fair value of our
stock price, future foreign exchange rates of the U.S. dollar to the euro and future profitability
of our German subsidiary. At each reporting date, we review applicable assumptions and estimates
relating to fair value and record any changes in the statement of operations.
40
Foreign Exchange Gains and Losses
We have a 100%-owned subsidiary in Germany, EpiCept GmbH, that performs certain pre-marketing
and commercialization activities on our behalf. EpiCept GmbH has generally been unprofitable since
its inception. Its functional currency is the euro. The process by which EpiCept GmbHs financial
results are translated into U.S. dollars is as follows: income statement accounts are translated at
average exchange rates for the period and balance sheet asset and liability accounts are translated
at end of period exchange rates. Translation of the balance sheet in this manner affects the
stockholders deficit account, referred to as the cumulative translation adjustment account. This
account exists only in EpiCept GmbHs U.S. dollar balance sheet and is necessary to keep the
foreign balance sheet stated in U.S. dollars in balance.
Certain of our debt instruments, originally expressed in German deutsche marks, are now
denominated in euros. Changes in the value of the euro relative to the value of the U.S. dollar
will affect the U.S. dollar value of our indebtedness at each reporting date as substantially all
of our assets are held in U.S. dollars. These changes are recognized by us as a foreign currency
transaction gain or loss, as applicable, and are reported in other expense or income in our
consolidated statements of operations.
Research and Development Expenses
We expect that a large percentage of our future research and development expenses will be
incurred in support of current and future preclinical and clinical development programs. These
expenditures are subject to numerous uncertainties in timing and cost to completion. We test our
product candidates in numerous preclinical studies for toxicology, safety and efficacy. We then
conduct early stage clinical trials for each drug candidate. As we obtain results from clinical
trials, we may elect to discontinue or delay clinical trials for certain product candidates or
programs in order to focus resources on more promising product candidates or programs. Completion
of clinical trials may take several years but the length of time generally varies according to the
type, complexity, novelty and intended use of a drug candidate. The cost of clinical trials may
vary significantly over the life of a project as a result of differences arising during clinical
development, including:
|
|
|
the number of sites included in the trials; |
|
|
|
|
the length of time required to enroll suitable patients; |
|
|
|
|
the number of patients that participate in the trials; |
|
|
|
|
the number of doses that patients receive; |
|
|
|
|
the duration of follow-up with the patient; |
|
|
|
|
the product candidates phase of development; and |
|
|
|
|
the efficacy and safety profile of the product. |
Expenses related to clinical trials are based on estimates of the services received and
efforts expended pursuant to contracts with multiple research institutions and clinical research
organizations that conduct clinical trials on the our behalf. The financial terms of these
agreements are subject to negotiation and vary from contract to contract and may result in uneven
payment flows. If timelines or contracts are modified based upon changes in the clinical trial
protocol or scope of work to be performed, estimates of expenses are modified accordingly on a
prospective basis.
Ceplene® has been granted full marketing authorization by the European Commission
for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid
Leukemia in first remission. None of our other drug candidates has received FDA or foreign
regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory
agencies must conclude that our clinical data and that of our collaborators establish the safety
and efficacy of our drug candidates. Furthermore, our strategy includes entering into
collaborations with third parties to participate in the development and commercialization of our
products. In the event that third parties have control over the preclinical development or clinical
trial process for a product candidate, the estimated completion date would largely be under control
of that third party rather than under our control. We cannot forecast with any degree of certainty
which of our drug candidates will be subject to future collaborations or how such arrangements
would affect our development plan or capital requirements.
Results of Operations
Years Ended December 31, 2009 and 2008
Revenues. During the years 2009 and 2008, we recognized revenue of approximately $0.4 million
and $0.3 million, respectively, from prior upfront licensing fees and milestone payments received
from Myriad, Endo, DURECT and GNI, Ltd. and royalties with respect to certain technology; and sales
of Ceplene® via the named-patient program. We recognized revenue from our agreement with Endo using
the proportional performance method with respect to LidoPAIN BP and on a straight line method over
the life of
the last to expire patent with Myriad and DURECT. During the years 2009 and 2008, we
recognized revenue of $40,000 and $43,000 from royalties with respect to acquired Maxim technology.
41
The current portion of deferred revenue as of December 31, 2009 of $0.4 million represents our
estimate of revenue to be recognized over the next twelve months primarily related to the upfront
payments from Myriad, Endo, DURECT and GNI, Ltd.
General and administrative expense. General and administrative expense decreased by 21%, or
$2.1 million, to $7.5 million for 2009 from $9.6 million in 2008. The overall decrease in
administrative expense can be attributed to a cost reduction effort implemented in 2008 and
continued into 2009. For 2009, stock-based compensation charges amounted to $0.9 million, or a
decrease of $0.9 million from 2008. In addition, our legal, accounting and public reporting
expense decreased $0.5 million and our facility, insurance and other administrative expenses
decreased $0.7 million for 2009 as compared to the same period in 2008.
Research and development expense. Research and development expense decreased by 8%, or $1.0
million, to $11.6 million for 2009 from $12.6 million for 2008. The decrease was primarily
attributable to lower clinical trial and consulting expenses of $0.4 million, lower salary and
salary related expenses of $1.1 million and lower patent expenses of $0.2 million in 2009 as
compared to the same period in 2008, partially offset by a $0.8 million facility expense and $0.2
million in severance expense related to closing our research facility in San Diego.
During 2009, our clinical efforts were focused on the completion of our clinical trials of
NP-1 and our Phase I clinical trial of crinobulin and the commencement of our open label trial of
Ceplene® that will meet our post-approval requirements with the EMEA. During 2008, our clinical
efforts were focused on the clinical trials of NP-1 and the ongoing Phase I clinical trial of
crinobulin, preparation for the Oral Explanation meeting with the CHMP, the scientific committee of
the EMEA, regarding the remaining outstanding issues on the MAA for Ceplene® and
preparation for the reexamination of the negative determination issued by the CHMP regarding our
marketing application for Ceplene®.
For the years ended December 31, 2009 and 2008, we incurred the following research and development
expense:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Direct Expenses: |
|
|
|
|
|
|
|
|
Ceplene® |
|
$ |
3,896 |
|
|
$ |
2,004 |
|
NP-1 |
|
|
971 |
|
|
|
2,584 |
|
Crinobulin |
|
|
705 |
|
|
|
908 |
|
Other projects |
|
|
46 |
|
|
|
357 |
|
|
|
|
|
|
|
|
|
|
|
5,618 |
|
|
|
5,853 |
|
|
|
|
|
|
|
|
Indirect Expenses: |
|
|
|
|
|
|
|
|
Staffing |
|
|
2,591 |
|
|
|
3,855 |
|
Other indirect |
|
|
3,394 |
|
|
|
2,915 |
|
|
|
|
|
|
|
|
|
|
|
5,985 |
|
|
|
6,770 |
|
|
|
|
|
|
|
|
Total Research & Development |
|
$ |
11,603 |
|
|
$ |
12,623 |
|
|
|
|
|
|
|
|
Direct expenses consist primarily of fees paid to vendors and consultants for services
related to preclinical product development, clinical trials, and manufacturing of the respective
products. Generally, we have flexibility with respect to the timing and magnitude of a significant
portion of our direct expenses. Indirect expenses are those expenses we incur that are not
allocated by project, which consist primarily of the salaries and benefits of our research and
development staff and related premises.
42
Other income (expense), net. Our other income (expense), net consisted of the following for
the years ended December 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Other income (expense), net consist of: |
|
|
|
|
|
|
|
|
Interest expense (1) |
|
$ |
(20,021 |
) |
|
$ |
(1,266 |
) |
Change in value of warrants and derivatives |
|
|
(305 |
) |
|
|
113 |
|
Interest income |
|
|
32 |
|
|
|
33 |
|
Loss on extinguishment of debt |
|
|
|
|
|
|
(1,975 |
) |
Foreign exchange gain (loss) |
|
|
221 |
|
|
|
(327 |
) |
|
|
|
|
|
|
|
Other expense, net |
|
$ |
(20,073 |
) |
|
$ |
(3,422 |
) |
|
|
|
|
|
|
|
|
|
|
(1) |
|
Amortization of debt issuance costs and discount and interest expense were both
accelerated in 2009 as a result of the conversion of $24.5 million of our 7.5556%
convertible subordinated notes due 2014 into approximately 9.1 million shares of our common
stock in 2009. Interest expense for the year ended December 31, 2009 included $10.5
million in amortization of debt issuance costs and discount and $9.3 million in interest
expense paid from escrowed cash that represented the make-whole interest payment that would
have been due at maturity of such notes. |
During 2009, we recorded other expense, net of $20.1 million as compared to other expense, net
of $3.4 million during 2008. The $16.7 million increase in other expense, net was primarily
related to $10.5 million in amortization of debt issuance costs and discount and $9.3 million in
interest expense, which was paid from restricted cash, as a result of the conversion of $24.5
million of our 7.5556% convertible subordinated notes due 2014 into approximately 9.1 million
shares of our common stock in 2009. Other income (expense) was positively impacted by a $0.5
million change in foreign exchange gains though it was substantially offset by a $0.4 million
decrease in the fair value of certain warrants and derivatives. The Company experienced a loss on
extinguishment of debt of $2.0 million in 2008.
Income Taxes. Income tax expense for the years ended December 31, 2009 and 2008 was $4,000 and
$3,000, respectively. As of December 31, 2009 and 2008, we had federal net operating loss
carryforwards, or NOLs, of $90.8 and $87.4 million, state NOLs of $95.5 and $95.6 million, and
foreign NOLs of $15.0 and $14.7 million respectively, available to reduce future taxable income.
Our federal and state NOLs will begin to expire after 2012 through 2029. In accordance with ASC
740, Income Taxes, we have provided a valuation allowance for the full amount of our net deferred
tax assets because it is not more likely than not that we will realize future benefits associated
with these deferred tax assets at December 31, 2009 and 2008.
Years Ended December 31, 2008 and 2007
Revenues. During each of the years 2008 and 2007, we recognized revenue of approximately $0.3
million from prior upfront licensing fees and milestone payments received from Endo and DURECT and
royalties with respect to certain technology. We recognized revenue from our agreement with Endo
using the proportional performance method with respect to LidoPAIN BP. During 2008 and 2007, we
recorded revenue from Endo of $32,000 and $0.2 million, respectively. In December 2006, we received
an upfront license fee payment of $1.0 million from DURECT. We recognize revenue from our
agreement with DURECT on a straight line basis over the life of the last to expire patent. During
each of the years 2008 and 2007 we recognized deferred revenue of approximately $0.1 relating to
our agreement with DURECT and $43,000 from royalties with respect to acquired Maxim technology.
The current portion of deferred revenue as of December 31, 2008 of $0.5 million represents our
estimate of revenue to be recognized over the next twelve months primarily related to the upfront
payments from Endo and DURECT.
General and administrative expense. General and administrative expense decreased by 18%, or
$2.2 million, to $9.6 million for 2008 from $11.8 million in 2007. The overall decrease in
administrative expense can be attributed to a cost reduction effort implemented in 2008. For 2008,
stock-based compensation charges amounted to $1.8 million, or a decrease of $0.3 million from 2007.
In addition, our accounting and public reporting expense decreased $0.9 million and our personnel,
investor relations, insurance and other administrative expenses decreased $1.0 million for 2008 as
compared to the same period in 2007.
Research and development expense. Research and development expense decreased by 18%, or $2.7
million, to $12.6 million for 2008 from $15.3 million for 2007. The decrease was primarily
attributable to lower clinical, preclinical and manufacturing expenses totaling $1.7 million and
lower depreciation expense of $0.5 million in 2008 as compared to the same period in 2007. In
addition, we recorded a $0.4 million non-cash charge relating to the issuance of warrants in
connection with the termination of a sublicense
agreement with Epitome Analgesics Inc., or Epitome, in 2007. Finally, our license fees
decreased by approximately $0.2 million during 2008, compared to 2007 primarily as a result of
terminating our sub-license agreement with Epitome and entering into a direct license agreement
with Dalhousie (see License Agreements).
43
During 2008, our clinical activity decreased as we concluded our clinical trials for NP-1 and
our Phase I clinical trial for crinobulin. Our main focus was on the preparation for the Oral
Explanation meeting with the CHMP, the scientific committee of the EMEA, regarding the remaining
outstanding issues on the MAA for Ceplene® and preparation for the reexamination of the
negative determination issued by the CHMP regarding our marketing application for
Ceplene®. During 2007, our clinical activity was focused on completing the preparation
for the clinical trials of NP-1, two of which commenced in April 2007, and the continuation of our
Phase I clinical trial of crinobulin. We received and reviewed the Day 80 report, the Day 120 List
of Questions Report and the Day 150 List of Questions Report related to the Ceplene®
MAA, and prepared our response to the EMEA.
For the years ended December 31, 2008 and 2007, we incurred the following research and development
expense:
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Direct Expenses: |
|
|
|
|
|
|
|
|
Ceplene® |
|
$ |
2,004 |
|
|
$ |
1,922 |
|
NP-1 |
|
|
2,584 |
|
|
|
3,912 |
|
Crinobulin |
|
|
908 |
|
|
|
1,367 |
|
Other projects |
|
|
357 |
|
|
|
510 |
|
|
|
|
|
|
|
|
|
|
|
5,853 |
|
|
|
7,711 |
|
|
|
|
|
|
|
|
Indirect Expenses: |
|
|
|
|
|
|
|
|
Staffing |
|
|
3,855 |
|
|
|
3,750 |
|
Other indirect |
|
|
2,915 |
|
|
|
3,851 |
|
|
|
|
|
|
|
|
|
|
|
6,770 |
|
|
|
7,601 |
|
|
|
|
|
|
|
|
Total Research & Development |
|
$ |
12,623 |
|
|
$ |
15,312 |
|
|
|
|
|
|
|
|
Direct expenses consist primarily of fees paid to vendors and consultants for services
related to preclinical product development, clinical trials, and manufacturing of the respective
products. We generally maintain few fixed commitments; therefore, we have flexibility with respect
to the timing and magnitude of a significant portion of our direct expenses. Indirect expenses are
those expenses we incur that are not allocated by project, which consist primarily of the salaries
and benefits of our research and development staff and related premises.
Other income (expense), net. Our other income (expense), net consisted of the following for
the years ended December 31, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Other income (expense), net consist of: |
|
|
|
|
|
|
|
|
Interest expense |
|
$ |
(1,266 |
) |
|
$ |
(2,287 |
) |
Change in value of warrants and derivatives |
|
|
113 |
|
|
|
(794 |
) |
Interest income |
|
|
33 |
|
|
|
113 |
|
(Loss) gain on extinguishment of debt |
|
|
(1,975 |
) |
|
|
493 |
|
Foreign exchange (loss) gain |
|
|
(327 |
) |
|
|
530 |
|
|
|
|
|
|
|
|
Other expense, net |
|
$ |
(3,422 |
) |
|
$ |
(1,945 |
) |
|
|
|
|
|
|
|
During 2008, we recorded other expense, net of $3.4 million as compared to other expense, net
of $2.0 million during 2007. The $1.5 million increase in other expense, net was primarily related
to a loss on extinguishment of debt of $2.0 million and a larger foreign exchange loss of $0.9
million, partially offset by lower interest expense of $1.0 million and a $0.9 million increase in
the fair value of certain warrants and derivatives. On June 23, 2008, we entered into a second
amendment to our senior secured term loan agreement. Under this amendment, we paid the lender,
Hercules, a $0.3 million restructuring fee and $0.5 million from the restricted cash account toward
the last principal installments owed on the loan. The applicable interest rate on the balance of
the loan was increased from 11.7% to 15.0% and the repayment schedule was modified and accelerated.
In addition, we were required to make contingent payments of $0.5 million if Ceplene®
is approved in Europe which was paid in September 2008, and $0.3 million if the primary endpoints
of the NP-1 trial yields statistically significant results, which was paid in February 2009 as a
result of receiving statistically significant results in January 2009. We also permitted Hercules
to convert up to $1.9 million of the outstanding principal balance into shares of our common stock
at a price above the market price of our common stock on the date of the amendment. Finally, we
issued Hercules warrants to purchase an aggregate of 1.3 million
44
shares of
our common stock at an exercise price of $1.17 per share and an aggregate of 0.3 million shares our common stock at
an exercise price of $1.23 per share. We considered this a substantial modification to the
original debt agreement and we have recorded the new debt at its fair value in accordance with EITF
Issue No. 96-19, Debtors Accounting for a
Modification of Debt Instruments (EITF 96-19). As a
result of the modification to the original debt agreement, we recorded a loss on the extinguishment
of debt of $2.0 million in June 2008. In 2007, we recorded a $0.5 million gain on extinguishment
of debt relating to the repayment agreement with tbg (see Contractual Obligations).
Income Taxes. Income tax expense for the years ended December 31, 2008 and 2007 was $3,000 and
$4,000, respectively. As of December 31, 2008 and 2007, we had federal net operating loss
carryforwards, or NOLs, of $87.4 and $72.8 million, state NOLs of $95.6 and $77.6 million, and
foreign NOLs of $14.7 and $13.6 million respectively, available to reduce future taxable income.
Our federal and state NOLs will begin to expire after 2012 through 2028. In 2007 we determined that
an ownership change occurred under Section 382 of the Internal Revenue Code. As a result, the
utilization of our net operating loss carryforwards and other tax attributes will be limited to
approximately $1.6 million per year. We also determined that we were in a Net Unrealized Built-in
Gain position (for purposes of Section 382) at the time of the ownership change, which increases
our annual limitation through 2011 by approximately $2.9 million per year. Accordingly, we have
reduced our net operating loss carryforwards and research and development tax credits to the amount
that we estimate that we will be able to utilize in the future, if we are profitable, considering
the above limitations. In accordance with ASC 740, Income Taxes, we have provided a valuation
allowance for the full amount of our net deferred tax assets because it is not more likely than not
that we will realize future benefits associated with these deferred tax assets at December 31, 2008
and 2007.
License Agreements
In January 2010, we entered into an exclusive commercialization agreement for
Ceplene® with Meda AB, a leading international specialty pharmaceutical company based in
Stockholm, Sweden. Under the terms of the agreement, we granted Meda the right to market
Ceplene® in Europe and several other countries including Japan, China, and Australia.
We received a $3 million fee on signing and will receive an additional $2 million upon the first
commercial launch of Ceplene in a major European market. We will also receive other milestone
payments and a double digit percent royalty on net sales in the covered territories. Additionally,
we will be responsible for Ceplenes commercial supply.
On December 20, 2006, we entered into a license agreement with DURECT, pursuant to which we
granted DURECT the exclusive worldwide rights to certain of our intellectual property for a
transdermal patch containing bupivacaine for the treatment of back pain. Under the terms of the
agreement, we received a $1.0 million payment. In September 2008, the Company amended its license
agreement with DURECT. Under the terms of the amended agreement, the Company granted DURECT
royalty-free, fully paid up, perpetual and irrevocable rights to the intellectual property licensed
as part of the original agreement in exchange for a cash payment of $2.25 million from DURECT. As
of December 31, 2009, we recorded inception to date revenue of $0.5 million related to this license
agreement.
In December 2003, we entered into a license agreement with Endo under which we granted Endo
(and its affiliates) the exclusive (including as to us and our affiliates) worldwide right to
commercialize LidoPAIN BP. We also granted Endo worldwide rights to certain of our other patents
used by Endo in the development of certain Endo products, including Lidoderm®, Endos
topical lidocaine-containing patch, for the treatment of chronic lower back pain. We remain
responsible for continuing and completing the development of LidoPAIN BP, including the conduct of
all clinical trials and the supply of the clinical products necessary for those trials and the
preparation and submission of the NDA in order to obtain regulatory approval for LidoPAIN BP. Upon
the execution of the Endo agreement, we received a payment of $7.5 million, which has been deferred
and is being recognized as revenue on the proportional performance method, and we are eligible to
receive payments of up to $52.5 million upon the achievement of various milestones relating to
product development and regulatory approval for both our LidoPAIN BP product candidate and Endos
own back pain product candidate, so long as, in the case of Endos product candidate, our patents
provide protection thereof. As of December 31, 2008, we recorded inception to date revenue related
to this license agreement in the amount of $1.6 million of which $33,000 was recorded as revenue
during 2008. We may also receive royalties from Endo based on the net sales of LidoPAIN BP. These
royalties are payable until generic equivalents of the LidoPAIN BP product candidate are available
or until expiration of the patents covering LidoPAIN BP, whichever is sooner. We are also eligible
to receive milestone payments from Endo of up to approximately $30.0 million upon the achievement
of specified net sales milestones of covered Endo products, including Lidoderm®, Endos
chronic lower back pain product candidate, so long as our patents provide protection thereof. The
total amount of upfront and milestone payments we are eligible to receive under the Endo agreement
is $90.0 million. No progress in the development of LidoPAIN BP or Lidoderm with respect to back
pain has been reported. Accordingly, we do not expect to receive any further compensation pursuant
to this license agreement.
45
In connection with our merger with Maxim on January 4, 2006, we acquired a license agreement
with Myriad under which we
licensed our MX90745 series of caspase-inducer anti-cancer compounds to Myriad. Myriad has
initiated clinical trials for AzixaTM, also known as MPC6827 and a MX90745 series
compound, for the treatment of brain cancer. We are also eligible to receive milestone payments
from Myriad of up to approximately $24.0 million upon the achievement of specified net sales
milestones of covered Myriad products. The total amount of upfront and milestone payments we are
eligible to receive under the Myriad agreement is $27.0 million. There is no certainty that any of
these milestones will be achieved or any royalty earned. Under the terms of the agreement, Myriad
is responsible for the worldwide development and commercialization of any drug candidates from this
series of compounds. The agreement requires that Myriad make licensing, research and milestone
payments to us assuming the successful commercialization of a compound for the treatment of cancer,
as well as pay a royalty on product sales. In September 2006, Myriad announced positive Phase I
clinical trial results for AzixaTM and in March 2007 announced that it had commenced a
registration size clinical trial for the product candidate. In March 2008, we received a milestone
payment of $1.0 million upon dosing of the first patient in this trial. As of December 31, 2009, we
recorded inception to date revenue of $0.1 million related to this license agreement.
Liquidity and Capital Resources
We have devoted substantially all of our cash resources to research and development programs
and general and administrative expenses. To date, we have not generated any meaningful revenues
from the sale of products and may not generate any such revenues for a number of years, if at all.
As a result, we have incurred an accumulated deficit of $235.0 million as of December 31, 2009, and
we anticipate that we will continue to incur operating losses in the future. Our recurring losses
from operations and our stockholders deficit raise substantial doubt about our ability to continue
as a going concern. Should we be unable to generate sufficient revenue from the sale of
Ceplene® or raise adequate financing in the future, operations will need to be scaled
back or discontinued. Since our inception, we have financed our operations primarily through the
proceeds from the sales of common and preferred securities, debt, revenue from collaborative
relationships, investment income earned on cash balances and short-term investments and the sales
of a portion of our New Jersey net operating loss carryforwards.
The following table describes our liquidity and financial position on December 31, 2009 and
2008.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Working capital (deficit) |
|
$ |
1,407 |
|
|
$ |
(8,535 |
) |
Cash and cash equivalents |
|
|
5,142 |
|
|
|
790 |
|
Notes and loans payable, current portion |
|
|
985 |
|
|
|
3,275 |
|
Notes and loans payable, long term portion |
|
$ |
967 |
|
|
$ |
277 |
|
Working Capital (Deficit)
As of December 31, 2009, we had working capital of $1.4 million, consisting of current assets of
$6.9 million and current liabilities of $5.5 million. This represents a favorable change in working
capital of approximately $9.9 million from our working capital deficit of $8.5 million on current
assets of $1.2 million and current liabilities of $9.7 million as of December 31, 2008. We funded
our working capital deficit and the cash portion of our 2009 operating loss with proceeds from our
June 2009, February 2009 and December 2008 financings. In January 2010, the Company received $3
million from Meda in connection with the signing of the Ceplene® European marketing and
distribution agreement. Meda is also required to pay an additional $2 million upon its commercial
launch of Ceplene® and a royalty on net sales. We believe our cash will be sufficient to fund our
operations and meet debt service requirements into the third quarter 2010. To conserve cash, we
may delay or cancel some of our planned development activities that are not related to
Ceplene® during 2010.
Cash and Cash Equivalents
At December 31, 2009, our cash and cash equivalents totaled $5.1 million. At December 31,
2008, cash and cash equivalents totaled $0.8 million. Our cash and cash equivalents consist
primarily of an interest bearing money market account. In June 2009, we sold approximately 4.0
million shares of common stock and warrants to purchase 1.4 million shares of common stock for
gross proceeds of $9.6 million, $8.9 million net of $0.7 million in transaction costs. In February
2009, we received net proceeds of approximately $14.0 million, after $1.6 million in transaction
costs and establishing a restricted cash account of $9.4 million for make-whole interest, from the
issuance of $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated
notes due February 2014 and five and one-half year warrants to purchase approximately 4.2 million
shares of the Companys common stock at an exercise price of $3.105 per share.
46
In December 2008, we received $1.0 million in net proceeds from the issuance of convertible
subordinated notes due April 2009. On August 11, 2008, we sold approximately 1.7 million shares of
common stock and warrants to purchase 1.0 million shares of common stock for gross proceeds of $4.0
million, $3.7 million net of $0.3 million in transactions costs. In addition, in consideration of
the receipt of $1.3 million in connection with the exercise of all of the warrants issued in
connection with our August 1, 2008 public offering, we issued to the investors in that offering new
warrants to purchase up to approximately 1.0 million shares of our Common Stock. On August 1, 2008,
we sold approximately 1.8 million shares of common stock and warrants to purchase 1.0 million
shares of common stock for gross proceeds of $3.0 million, $2.8 million net of $0.2 million in
transactions costs. In July 2008, we sold approximately 0.7 million shares of common stock and
warrants to purchase 0.7 million shares of common stock for gross proceeds of $0.5 million, $0.5
million net of $50,000 in transactions costs. In June 2008, we sold approximately 2.7 million
shares of common stock and warrants to purchase 2.7 million shares of common stock for gross
proceeds of $2.0 million, $1.8 million net of $0.2 million in transaction costs. In March 2008, we
sold approximately 1.8 million shares of common stock and warrants to purchase 0.9 million shares
of common stock for gross proceeds of $5.0 million, $4.7 million net of $0.3 million in
transactions costs.
Current and Future Liquidity Position
During 2009, we raised gross proceeds of $34.6 million, $22.9 million net of $2.3 million in
transaction costs and establishing a restricted cash account of $9.4 million for make-whole
interest. As of December 31, 2009 we had approximately $5.1 million in cash and cash equivalents.
In January 2010 we received $3 million from Meda AB in connection with the signing of the Ceplene
European marketing and distribution agreement with Meda. Meda is also required to pay an
additional $2 million upon its commercial launch of Ceplene® and a royalty on net sales. Our
anticipated average monthly cash operating expenses in 2010 is approximately $1.6 million per
month. In addition, we are required to make interest and principal payments to our lender tbg on
each of June 30, 2010 and December 31, 2010 in the amount of approximately $0.5 million. We believe
that our cash is sufficient to fund operations into the third quarter 2010. We may receive cash
from certain of our licensing partners during 2010 for achievement of clinical milestones, and we
may raise additional funds through the issuance of debt and/or equity to meet our cash needs. To
conserve cash, we may delay or cancel some of our planned development activities that are not
related to Ceplene during 2010.
We plan to out license our NP-1 compound to a third party who will agree to complete clinical
development and commercialize the product upon receipt of necessary regulatory approvals.
Discussions with prospective partners are continuing, however at this time we are unable to
determine whether or when such an agreement might be concluded or the amount of any fees that may
be paid to us in 2010 in connection with the agreement.
In February 2010, we established an At-the-Market offering program through which we may,
from time to time, offer and sell shares of our common stock having an aggregate offering price of
up to $15.0 million from time to time through our sales agent. Sales of the shares, if any, will
be made by means of ordinary brokers transactions on The Nasdaq Capital Market or, to the extent
allowable by law, the Nasdaq OMX Stockholm Exchange, at market prices. Additionally, under the
terms of the sales agreement, we may also sell shares of our common stock through the sales agent
on The Nasdaq Capital Market or, to the extent allowable by law, the Nasdaq OMX Stockholm Exchange,
or otherwise, at negotiated prices or at prices related to the prevailing market price. We will
designate the maximum amount of shares of common stock to be sold on a daily basis as we and our
sales agent may agree. We plan to utilize this program at such times and in such amounts so as to
minimize disruption to the trading of our stock, and therefore in times of low trading volume we
may severely limit or refrain from using the program. If we are unable to meet our liquidity needs
through this program, we may seek alternative sources of equity and/or debt.
If additional funds are raised by issuing equity, substantial dilution to existing
shareholders may result. If we fail to obtain capital when required, we may be forced to delay,
scale back, or eliminate some or all of our commercialization efforts for Ceplene and our research
and development programs or to cease operations entirely.
47
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include, but are not limited to, the following:
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revenues generated from the sale of Ceplene® in Europe, including payments
from our marketing partner; |
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manufacturing costs of Ceplene® |
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|
the timing, receipt and amount of front-end fees and milestone payments that may
become payable through an NP-1 license; |
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|
progress in our research and development programs, as well as the magnitude of these
programs; |
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|
the timing, receipt and amount of milestone and other payments, if any, from present
and future collaborators, if any; |
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|
the ability to establish and maintain additional collaborative arrangements; |
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|
the resources, time and costs required to successfully initiate and complete our
preclinical and clinical trials, obtain regulatory approvals, protect our intellectual
property; |
|
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|
the cost of preparing, filing, prosecuting, maintaining and enforcing patent claims;
and |
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|
the timing, receipt and amount of sales and royalties, if any, from our potential
products. |
Our ability to raise additional capital will depend on financial, economic and market
conditions and other factors, many of which are beyond our control. We cannot be certain that such
additional funding will be available upon acceptable terms, or at all. To the extent that we raise
additional capital by issuing equity securities, our then-existing stockholders may experience
further dilution. Our sales of equity have generally included the issuance of warrants, and if
these warrants are exercised in the future, stockholders may experience significant additional
dilution. We may not be able to raise additional capital through the sale of our securities which
would severely limit our ability to fund our operations. Debt financing, if available, may subject
us to restrictive covenants that could limit our flexibility in conducting future business
activities. Given our available cash resources, existing indebtedness and results of operations,
obtaining debt financing may not be possible. To the extent that we raise additional capital
through collaboration and licensing arrangements, it may be necessary for us to relinquish valuable
rights to our product candidates that we might otherwise seek to develop or commercialize
independently.
In December 2006, we entered into a Standby Equity Distribution Agreement or SEDA with YA
Global Investments, L.P. We did not draw down on the SEDA, which expired in December 2009.
Operating Activities
Net cash used in operating activities was $29.5 million in 2009, as compared to $15.6 million
in 2008 and $25.8 million in 2007. In 2009, cash was primarily used to fund our net loss for the
year for research and development, general, administrative and interest expense. The net loss was
partially offset by non-cash charges of $10.5 million in amortization of deferred financing costs
and discount on loans, $1.4 million of stock-based compensation and $0.4 million of depreciation
and amortization expense. Inventory increased by $1.3 million as we prepared for the launch of
Ceplene in Europe and deferred revenue decreased by $0.4 million to account for the portion of the
Myriad, Endo and DURECT deferred revenue recognized as revenue. Accounts payable and accrued
expenses also decreased by $1.8 million as a result of payments to our vendors.
The 2008 net loss was partially offset by non-cash charges of $2.3 million of stock-based
compensation, $1.7 million related to the extinguishment of debt as a result of entering into a
second amendment with our senior secured lender in June 2008, and $0.6 million of depreciation and
amortization expense. Accounts payable increased by $1.5 million as a result of our delaying
payments to our vendors. Deferred revenue increased by $3.4 million as a result of receiving a
$1.0 million milestone payment from our partner, Myriad, following dosing of the first patient in a
Phase II registration sized clinical trial for AzixaTM and a $2.3 million payment from
DURECT upon granting DURECT royalty-free, fully paid up, perpetual and irrevocable rights to our
intellectual property for a transdermal patch containing bupivacaine for the treatment of back
pain, which was partially offset by $0.2 million to account for the portion of the Myriad, Endo and
DURECT deferred revenue recognized as revenue.
Investing Activities
Net cash used in investing activities was $0.1 million in 2009 compared with net cash provided
by investing activities of $0.3 million in 2008 and net cash used in investing activities of $0.2
million in 2007. In 2009, cash was used to establish restricted cash for a $9.4 million make-whole
interest payment resulting from the issuance of $25.0 million principal aggregate amount of 7.5556%
convertible senior subordinated notes, the release of $9.3 million from restricted cash to pay for
interest on the 7.5556% notes as the result of the conversion of $24.5 million in aggregate
principal amount of the 7.5556% notes, $0.1 million in proceeds from the sale of equipment in our
San Diego research facility and $27,000 for the purchase of equipment. In 2008, net cash provided
by investing activities consisted primarily of the release of restricted cash amounting to $0.3
million resulting from our failure to make
certain required lease payments when due and, as a result, the landlord exercised their right
to draw down our letter of credit. We do not anticipate significant capital expenditures in the
near future.
48
Financing Activities
Net cash provided by financing activities was $33.9 million in 2009 compared to $11.1 million
in 2008 and $16.8 million in 2007. In 2009, we issued $25.0 million principal aggregate amount of
7.5556% convertible senior subordinated notes, netting us $14.0 million after $1.6 million in
transaction costs and establishing a restricted cash account of $9.4 million for make-whole
interest. In June 2009, we raised $9.6 million gross proceeds, $8.9 million net of $0.7 million in
transaction costs, in connection with the issuance of common stock and warrants. We also received
proceeds of $3.9 million related to the exercise of approximately 3.4 million warrants in 2009. We
repaid the outstanding loan balance with Hercules of approximately $8,000 and deferred financing
costs of $0.2 million, resulting in our having no further obligations under this loan agreement.
We also repaid $1.0 million of the subordinated convertible notes due April 10, 2009 and paid $0.9
million towards the remaining balance of our loan with tbg. During 2008, we issued common stock
and common stock purchase warrants for $13.3 million, net of transaction costs of $1.1 million.
During 2008, we also issued $1.1 million in convertible subordinated debt, due April 2009.
Contractual Obligations
As of December 31, 2009, the annual amounts of future minimum payments under debt obligations,
interest, lease obligations and other long term liabilities consisting of research, development,
consulting and license agreements (including maintenance fees) are as follows (in thousands of U.S.
dollars, using exchange rates where applicable in effect as of December 31, 2009):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
|
|
|
1 Year |
|
|
1 3 Years |
|
|
3 5 Years |
|
|
5 Years |
|
|
Total |
|
Notes and loans payable |
|
$ |
985 |
|
|
$ |
618 |
|
|
$ |
500 |
|
|
$ |
|
|
|
$ |
2,103 |
|
Interest expense |
|
|
144 |
|
|
|
108 |
|
|
|
38 |
|
|
|
|
|
|
|
290 |
|
Operating leases |
|
|
1,064 |
|
|
|
1,863 |
|
|
|
661 |
|
|
|
|
|
|
|
3,588 |
|
Other obligations |
|
|
2,326 |
|
|
|
2,429 |
|
|
|
754 |
|
|
|
|
|
|
|
5,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,519 |
|
|
$ |
5,018 |
|
|
$ |
1,953 |
|
|
$ |
|
|
|
$ |
11,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.5 Million Due 2011. In August 1997, our subsidiary, EpiCept GmbH entered into a ten-year
non-amortizing loan in the amount of 1.5 million with Technologie-Beteiligungs Gesellschaft mbH
der Deutschen Ausgleichsbank, or tbg. The loan initially bore interest at 6% per annum. Tbg was
also entitled to receive additional compensation equal to 9% of the annual surplus (income before
taxes, as defined in the agreement) of EpiCept GmbH, reduced by any other compensation received
from EpiCept GmbH by virtue of other loans to or investments in EpiCept GmbH provided that tbg is
an equity investor in EpiCept GmbH during that time period. We considered the additional
compensation element based on the surplus of EpiCept GmbH to be a derivative. We assigned no value
to the derivative at each reporting period as no surplus of EpiCept GmbH was anticipated over the
term of the agreement. In addition, any additional compensation as a result of surplus would be
reduced by the additional interest noted below.
At the demand of tbg, additional amounts could have been due at the end of the loan term up to
30% of the loan amount, plus 6% of the principal balance of the loan for each year after the
expiration of the fifth complete year of the loan period, such payments to be offset by the
cumulative amount of all payments made to tbg from the annual surplus of EpiCept GmbH. We were
accruing these additional amounts as additional interest up to the maximum amount due over the term
of the loan.
On December 20, 2007, EpiCept GmbH entered into a repayment agreement with tbg, whereby
EpiCept GmbH paid tbg approximately 0.2 million ($0.2 million) in January 2008, representing
all interest payable to tbg as of December 31, 2007. The loan balance of 1.5 million ($2.0
million), plus accrued interest at a rate of 7.38% per annum beginning January 1, 2008 was required
to be repaid to tbg no later than June 30, 2008. Tbg waived any additional interest payments of
approximately 0.5 million ($0.7 million). EpiCept GmbH considered this a substantial
modification to the original debt agreement and has recorded the new debt at its fair value in
accordance with ASC 470-50, Modifications and Extinguishments (ASC 470-50). As a result of the
modification to the original debt agreement, EpiCept GmbH recorded a gain on the extinguishment of
debt of $0.5 million in December 2007. Accrued interest attributable to the additional interest
payments totaled $0 at December 31, 2009 and 2008.
On May 14, 2008, EpiCept GmbH entered into a prolongation of the repayment agreement with tbg,
whereby the loan balance of 1.5 million ($2.0 million) was required to be repaid to tbg no
later than December 31, 2008. Interest continued to accrue at a rate of 7.38% per annum and all
the provisions of the repayment agreement dated December 20, 2007 continued to apply without
change.
49
On November 26, 2008, EpiCept GmbH entered into a second amendment to the repayment agreement
with tbg, whereby the loan balance of 1.5 million ($2.0 million) was required to be repaid to
tbg no later than June 30, 2009. Interest will continue to accrue at a rate of 7.38% per annum and
all the provisions of the repayment agreement dated December 20, 2007 will continue to apply
without change.
On June 25, 2009, EpiCept GmbH entered into a third amendment to the repayment agreement with
tbg, whereby 0.3 million of the loan balance of 1.5 million ($2.1 million) plus accrued
interest of 56,000 ($0.1 million) was repaid to tbg on June 30, 2009. The remaining loan
balance of 1.2 million ($1.7 million) plus accrued interest will be paid in four semi-annual
installments of 0.3 million ($0.4 million) beginning December 31, 2009. Interest will continue
to accrue at a rate of 7.38% per annum and all the provisions of the repayment agreement dated
December 20, 2007 will continue to apply without change.
$25.0 million 7.5556% Convertible Notes Due 2014. On February 4, 2009, we issued $25.0 million
principal aggregate amount of 7.5556% convertible subordinated notes due February 2014 and five
and-a-half year warrants to purchase approximately 4.2 million shares of common stock at an
exercise price of $3.105 per share. Each $1,000 in principal aggregate amount of the notes is
initially convertible into approximately 371 shares of Common Stock, at the option of the holders
or upon specified events, including a change of control, and if the Companys common stock trades
at or greater than $5.10 a share for 20 out of 30 days, beginning February 9, 2010. Upon any
conversion or redemption of the notes, the holders will receive a make-whole payment in an amount
equal to the interest payable through the scheduled maturity of the converted or redeemed notes,
less any interest paid before such conversion or redemption. Interest is due and payable on the
notes semi-annually in arrears on June 30 and December 31, beginning on June 30, 2009.
The Company allocated the $25.0 million in proceeds between the convertible subordinated notes
and the warrants based on their relative fair values. The Company calculated the fair value of the
warrants at the date of the transaction at approximately $8.8 million with a corresponding amount
recorded as a debt discount. The debt discount is being accreted over the life of the outstanding
convertible subordinated notes using the effective interest method. At the date of the transaction,
the fair value of the warrants of $8.8 million was determined utilizing the Black-Scholes option
pricing model under the following assumptions: dividend yield of 0%, risk free interest rate of
1.99%, volatility of 118% and an expected life of five years. During 2009, the Company recognized
approximately $8.6 million of non-cash interest expense related to the accretion of the debt
discount as a result of the conversion of $24.5 million of the convertible subordinated notes into
approximately 9.1 million shares of the Companys common stock.
As of December 31, 2009, after giving effect to the conversions into common stock, the
remaining aggregate principal amount of the Notes outstanding is $0.5 million.
$1.1 million Subordinated Convertible Notes Due 2009. In December 2008, we completed the sale
of subordinated convertible notes due April 10, 2009 for aggregate proceeds of $1.0 million. The
notes were convertible into shares of our common stock at any time upon the election of the
Purchasers at $1.00 per share. The notes were subordinated to the senior secured loan. The notes
were issued as an original issue discount obligation in lieu of periodic interest payments and
therefore no interest payments were made under these notes. Accordingly, the aggregate principal
face amount of the notes was $1,112,500. We repaid these notes in January and February 2009.
$0.8 million Due 2012. In July 2006, Maxim, our wholly-owned subsidiary, issued a six-year
non-interest bearing promissory note in the amount of $0.8 million to Pharmaceutical Research
Associates, Inc., or PRA, as compensation for PRA assuming the liability on a lease in San Diego,
CA. The note is payable in seventy-two equal installments of approximately $11,000 per month. We
terminated our lease of certain property in San Diego, CA as part of our exit plan upon the
completion of the merger with Maxim on January 4, 2006. Our loan balance at December 31, 2009 is
$0.3 million.
Senior Secured Term Loan. In August 2006, we entered into a senior secured term loan in the
amount of $10.0 million with Hercules Technology Growth Capital, Inc., or Hercules. The interest
rate on the loan was initially 11.7% per year. In addition, we issued five year common stock
purchase warrants to Hercules granting them the right to purchase 0.2 million shares of our common
stock at an exercise price of $7.95 per share. As a result of certain anti-dilution adjustments
resulting from a financing consummated by us in December 2006 and an amendment entered into in
January 2007, the terms of the warrants issued to Hercules were adjusted to grant Hercules the
right to purchase an aggregate of 0.3 million shares of our common stock at an exercise price of
$4.38 per share. Hercules exercised 0.1 million warrants in August 2007 and had 0.2 million
warrants remaining as of this date. The basic terms of the loan required monthly payments of
interest only through March 1, 2007, with 30 monthly payments of principal and interest which
commenced on April 1, 2007. Any outstanding balance of the loan and accrued interest was to be
repaid on August 30, 2009. In connection with the terms of the loan agreement, we granted Hercules
a security interest in substantially all of the Companys personal property including its
intellectual property.
50
We allocated the $10.0 million in proceeds between the term loan and the warrants based on
their relative fair values. We calculated the fair value of the warrants at the date of the
transaction at approximately $0.9 million with a corresponding amount recorded as a debt discount.
The debt discount was being accreted over the life of the outstanding term loan using the effective
interest method. At the date of the transaction, the fair value of the warrants of $0.9 million was
determined utilizing the Black-Scholes option pricing model utilizing the following assumptions:
dividend yield of 0%, risk free interest rate of 4.72%, volatility of 69% and an expected life of
five years. During 2009 and 2008, we recognized approximately $0 and $0.1 million, respectively,
of non-cash interest expense related to the accretion of the debt discount. Since inception of the
term loan, we recognized approximately $0.8 million of non-cash interest expense related to the
accretion of the debt discount.
On May 5, 2008, we entered into the first amendment to the loan agreement. Under this
agreement we paid an amendment fee of $50,000, agreed to maintain, subject to certain exceptions, a
minimum cash balance of $0.5 million in our bank accounts that are subject to the security interest
maintained by Hercules under the loan agreement and to deliver an amendment to the warrant
agreement. On May 7, 2008, in connection with a second amendment to the warrant agreement with
Hercules, the terms of the warrants issued to Hercules were adjusted to grant Hercules the right to
purchase an aggregate of 0.7 million shares of our common stock at an exercise price of $0.90 per
share. As a result of this amendment, these warrants no longer met the requirements to be accounted
for as equity in accordance with ASC 815-40, Derivatives and Hedging Contracts in Entities Own
Equity (ASC 815-40).Therefore, the warrants were reclassified as a liability from equity for
approximately $0.4 million at the date of the amendment to the loan agreement. The value of the
warrants shares were being marked to market at each reporting period as a derivative gain or loss.
At June 30, 2008, the warrants met the requirements to be accounted for as equity in accordance
with ASC 815-40 and were reclassified as equity from a liability for $0.3 million. We recognized a
change in the fair value of warrants and derivatives of approximately $0.1 million as a gain on the
consolidated statement of operations. The warrants issued under this amendment were exercised in
full during the third quarter of 2008 and zero warrants were outstanding at December 31, 2009.
On June 23, 2008, we entered into the second amendment to the loan agreement. Under this
amendment, we paid Hercules a $0.3 million restructuring fee and $0.5 million from the restricted
cash account toward the last principal installments owed on the loan. The applicable interest rate
on the balance of the loan was increased from 11.7% to 15.0% and the repayment schedule was
modified and accelerated. In addition, we were required to make contingent payments of $0.5
million resulting from the approval of Ceplene®, which was paid in September 2008, and
$0.3 million if the Phase II trial for NP-1 yields statistically significant results of the primary
endpoints, which was paid in February 2009. Hercules was permitted to convert up to $1.9 million
of the outstanding principal balance into up to 1.2 million shares of our common stock at a price
of $1.545 per share. In October 2008 and December 2008, Hercules converted $1.9 million of the
outstanding loan balance into approximately 1.2 million shares of our common stock. As of December
31, 2009, there was no balance remaining on the senior secured loan.
Finally, in connection with the second amendment to the loan agreement, we issued Hercules
warrants to purchase an aggregate of 1.3 million shares of our common stock at an exercise price of
$1.17 per share and an aggregate of 0.3 million shares of our common stock at an exercise price of
$1.23 per share. We considered this a substantial modification to the original debt agreement and
recorded the new debt at its fair value in accordance with ASC 470-50. As a result of the
modification to the original debt agreement, we recorded a loss on the extinguishment of debt of
$2.0 million in June 2008. The warrants issued as a result of this amendment remain outstanding at
December 31, 2008. As of December 31, 2009, there were warrants to purchase an aggregate of 0.1
million shares of our common stock at an exercise price of $1.17 per share and warrants to purchase
an aggregate of 0.3 million shares of our common stock at an exercise price of $1.23 per share
outstanding as of this date.
Other Commitments. Our long-term commitments under operating leases shown above consist of
payments relating to our facility lease in Tarrytown, New York, which expires in February 2012, and
Munich, Germany, which expires in July 2010. Long-term commitments under operating leases for
facilities leased by Maxim and retained by us relate primarily to the research and development site
at 6650 Nancy Ridge Drive in San Diego, which is leased through October 2013. In June 2008, we
defaulted on our lease agreement for the premises located in San Diego, California by failing to
make the monthly rent payment. As a result, the landlord exercised their right to draw down the
full letter of credit, amounting to approximately $0.3 million, and applied approximately $0.2
million to unpaid rent. The remaining balance of $0.1 million is classified as prepaid rent. At
December 31, 2009, we are current with our lease payments on this facility. We discontinued our
drug discovery activities at this location and are currently looking to sublease the premises
located in San Diego, California. In July 2006, we terminated our lease of certain other property
in San Diego, California. In connection with the lease termination, we issued a six year
non-interest bearing note payable in the amount of $0.8 million to the new tenant. These payments
are reflected in the long-term debt section of the above table.
51
We have a number of research, consulting and license agreements that require us to make
payments to the other party to the agreement upon us attaining certain milestones as defined in the
agreements. As of December 31, 2009, we may be required to make future milestone payments, totaling
approximately $5.5 million, under these agreements, depending upon the success and
timing of future clinical trials and the attainment of other milestones as defined in the
respective agreement. Our current estimate as to the timing of other research, development and
license payments, assuming all related research and development work is successful, is listed in
the table above in Other obligations.
We are also obligated to make future royalty payments to three of our collaborators under
existing license agreements, based on net sales of Ceplene®, NP-1 and crinobulin, to the
extent revenues on such products are realized. We cannot reasonably determine the amount and timing
of such royalty payments and they are not included in the table above.
Recent Accounting Pronouncements
In February 2010, the Financial Accounting Standards Board (FASB) issued ASU 2010-09,
Subsequent Events (ASC Topic 855) Amendments to Certain Recognition and Disclosure
Requirements. ASU 2010-09 removes the requirement for an SEC filer to disclose a date in both
issued and revised financial statements. The adoption of this pronouncement did not have a
material effect on our consolidated financial statements.
In October 2009, the FASB approved for issuance Emerging Issues Task Force (EITF) issue 08-01,
Revenue Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting
Standards Codification (ASC) Subtopic 605-25). This statement provides principles for allocation of
consideration among its multiple-elements, allowing more flexibility in identifying and accounting
for separate deliverables under an arrangement. This guidance introduces an estimated selling price
method for valuing the elements of a bundled arrangement if vendor-specific objective evidence or
third-party evidence of selling price is not available, and significantly expands related
disclosure requirements. This standard is effective on a prospective basis for revenue arrangements
entered into or materially modified in fiscal years beginning on or after June 15, 2010.
Alternatively, adoption may be on a retrospective basis, and early application is permitted. We are
currently evaluating the impact of adopting this pronouncement.
In June 2009, the FASB issued ASC 105-10, Generally Accepted Accounting Principles (ASC
105-10). ASC 105-10 provides for the FASB Accounting Standards Codification (the Codification)
to become the single official source of authoritative, nongovernmental U.S. generally accepted
accounting principles (GAAP). The Codification did not change GAAP but reorganizes the
literature. ASC 105-10 is effective for interim and annual periods ending after September 15, 2009.
The adoption of this pronouncement did not have a material effect on our consolidated financial
statements.
In May 2009, the FASB issued ASC 855-10, Subsequent Events (ASC 855-10). The objective of
this statement is to establish principles and requirements for subsequent events. In particular,
ASC 855-10 sets forth the period after the balance sheet date during which management of a
reporting entity shall evaluate events or transactions that may occur for potential recognition or
disclosure in the financial statements, the circumstances under which an entity shall recognize
events or transactions occurring after the balance sheet date in its financial statements, and the
disclosures that an entity shall make about events or transactions that occurred after the balance
sheet date. ASC 855-10 is effective for interim or annual financial statements issued after June
15, 2009. The adoption of this pronouncement did not have a material effect on our consolidated
financial statements.
In March 2008, the FASB issued ASC 815-10, Derivatives and Hedging (ASC 815-10). ASC
815-10 requires that an entity provide enhanced disclosures related to derivative and hedging
activities. ASC 815-10 is effective for financial statements issued for fiscal years beginning
after December 15, 2008. The adoption of this pronouncement did not have a material effect on our
consolidated financial statements.
ITEM 7A. QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISKS
The financial currency of our German subsidiary is the euro. As a result, we are exposed to
various foreign currency risks. First, our consolidated financial statements are in U.S. dollars,
but a portion of our consolidated assets and liabilities is denominated in euros. Accordingly,
changes in the exchange rate between the euro and the U.S. dollar will affect the translation of
our German subsidiarys financial results into U.S. dollars for purposes of reporting consolidated
financial results. We also bear the risk that interest on our euro-denominated debt, when
translated from euros to U.S. dollars, will exceed our current estimates and that principal
payments we make on those loans may be greater than those amounts currently reflected on our
consolidated balance sheet. If the U.S. dollar depreciation to the euro had been 10% more
throughout 2009, we estimate that our interest expense and the fair value of our euro-denominated
debt would have increased by $14,000 and $0.1 million, respectively. Historically, fluctuations in
exchange rates resulting in transaction gains or losses have had a material effect on our
consolidated financial results. We have not engaged in any hedging activities to minimize this
exposure, although we may do so in the future.
52
Our exposure to interest rate risk is limited to interest income sensitivity, which is
affected by changes in the general level of U.S. interest rates, particularly because the majority
of our investments are in short-term debt securities and bank deposits. The
primary objective of our investment activities is to preserve principal while at the same time
maximizing the income we receive without significantly increasing risk. To minimize risk, we
maintain our portfolio of cash and cash equivalents in a variety of interest- bearing instruments,
primarily bank deposits and money market funds, which may also include U.S. government and agency
securities, high-grade U.S. corporate bonds and commercial paper. Due to the nature of our
short-term and restricted investments, we believe that we are not exposed to any material interest
rate risk. We do not have any relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured finance or special purpose entities,
which would have been established for the purpose of facilitating off-balance sheet arrangements or
other contractually narrow or limited purposes. In addition, we do not engage in trading activities
involving non-exchange traded contracts. Therefore, we are not materially exposed to any financing,
liquidity, market or credit risk that could arise if we had engaged in these relationships. We do
not have relationships or transactions with persons or entities that derive benefits from their
non-independent relationship with us or our related parties.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
See our consolidated financial statements filed with this Annual Report on Form 10-K under
Item 15 below.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer, with the assistance of other members
of our management, have evaluated the effectiveness of our disclosure controls and procedures (as
defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period
covered by this Annual Report on Form 10-K. Based on this evaluation, our Chief Executive Officer
and Chief Financial Officer have concluded that, as of December 31, 2009, our disclosure controls
and procedures were effective.
Managements Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over
financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. The
Companys internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with accounting principles generally accepted in the
United States of America.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Therefore, even those systems determined to be effective can provide only
reasonable assurance with respect to financial statement preparation and presentation. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
Management assessed the effectiveness of the Companys internal control over financial
reporting as of December 31, 2009. Management based this assessment on criteria for effective
internal control over financial reporting described in Internal Control-Integrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission. Managements
assessment included an evaluation of the design of the Companys internal control over financial
reporting and testing of the operational effectiveness of its internal control over financial
reporting. Management reviewed the results of its assessment with the Audit Committee.
There have not been any changes in our internal control over financial reporting (as defined
in Rule 13a-15(f)) during the fiscal quarter ended December 31, 2009 that have materially affected,
or are reasonably likely to materially affect, the Companys internal control over financial
reporting.
Based on this assessment, management determined that, as of December 31, 2009, the Companys
internal control over financial reporting was effective to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with accounting principles generally
accepted in the United States of America.
This Annual Report includes an attestation report of our independent registered public
accounting firm regarding the effectiveness of the Companys internal control over financial
reporting as of December 31, 2009, which is included herein.
53
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of
EpiCept Corporation
Tarrytown, NY
We have audited the internal control over financial reporting of EpiCept Corporation and
subsidiaries (the Company) as of December 31, 2009, based on criteria established in Internal
Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission. The Companys management is responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness of internal control over financial
reporting included in the accompanying managements report on internal control over financial
reporting. Our responsibility is to express an opinion on the Companys internal control over
financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk,
and performing such other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed by, or under the
supervision of, the companys principal executive and principal financial officers, or persons
performing similar functions, and effected by the companys board of directors, management, and
other personnel to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles. A companys internal control over financial reporting includes
those policies and procedures that (1) pertain to the maintenance of records that, in reasonable
detail, accurately and fairly reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted accounting principles,
and that receipts and expenditures of the company are being made only in accordance with
authorizations of management and directors of the company; and (3) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the financial statements.
Because of the inherent limitations of internal control over financial reporting, including the
possibility of collusion or improper management override of controls, material misstatements due to
error or fraud may not be prevented or detected on a timely basis. Also, projections of any
evaluation of the effectiveness of internal control over financial reporting to future periods are
subject to the risk that the controls may become inadequate because of changes in conditions, or
that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, the Company maintained, in all material respects, effective internal control over
financial reporting as of December 31, 2009, based on criteria established in Internal Control -
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the consolidated financial statements as of and for the year ended
December 31, 2009 of the Company and our report dated March 12, 2010 expressed an unqualified
opinion on those financial statements and included an explanatory paragraph regarding the Companys
ability to continue as a going concern.
/s/ DELOITTE & TOUCHE LLP
Parsippany, New Jersey
March 12, 2010
54
ITEM 9B. OTHER INFORMATION
None.
55
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Management and Board of Directors
We have a strong team of experienced business executives, scientific professionals and medical
specialists. Our executive officers and directors, their ages and positions as of March 5, 2010 are
as follows:
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Name |
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Age |
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Position/Affiliation |
John V. Talley
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54 |
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President, Chief Executive Officer and Director |
Robert W. Cook
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54 |
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Chief Financial Officer Senior Vice President,
Finance and Administration, and Secretary |
Stephane Allard, M.D.
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56 |
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Chief Medical Officer |
Dileep Bhagwat, Ph.D.
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59 |
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Senior Vice President, Pharmaceutical Development |
Michael Chen
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60 |
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Vice President, Global Business Development |
Ben Tseng, Ph.D.
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65 |
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Chief Scientific Officer |
Robert G. Savage
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56 |
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Chairman of the Board |
Guy C. Jackson
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67 |
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Director |
Gerhard Waldheim
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61 |
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Director |
Wayne P. Yetter
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64 |
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Director |
A. Collier Smyth, M.D.
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64 |
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Director |
Executive Officers and Key Employees
John V. Talley has been our President, Chief Executive Officer and a Director since October
2001. Mr. Talley has more than 30 years of experience in the pharmaceutical industry. Prior to
joining us, Mr. Talley was the Chief Executive Officer of Consensus Pharmaceuticals, a
biotechnology drug discovery start-up company that developed a proprietary peptide-based
combinatorial library screening process. Prior to joining Consensus, Mr. Talley led Penwest Ltd.s
efforts in its spin-off of its subsidiary Penwest Pharmaceuticals Co. in 1998 and served as
President and Chief Operating Officer of Penwest Pharmaceuticals. Mr. Talley started his career at
Sterling Drug Inc., where he was responsible for all U.S. marketing activities for prescription
drugs, helped launch various new pharmaceutical products and participated in the 1988 acquisition
of Sterling Drug by Eastman Kodak Co. Mr. Talley received his B.S. in Chemistry from the University
of Connecticut and completed coursework towards an M.B.A. in Marketing from New York University,
Graduate School of Business.
Robert W. Cook has been our Chief Financial Officer and Senior Vice President, Finance and
Administration since April 2004. Prior to joining us, Mr. Cook was Vice President, Finance and
Chief Financial officer of Pharmos Corporation since January 1998 and became Executive Vice
President of Pharmos in February 2001. From May 1995 until his appointment as Pharmoss Chief
Financial Officer, he was a vice president in GE Capitals commercial finance subsidiary, based in
New York. From 1977 until 1995, Mr. Cook held a variety of corporate finance and capital markets
positions at The Chase Manhattan Bank, both in the United States and in several overseas locations.
He was named a managing director of Chase and several of its affiliates in January 1986. Mr. Cook
received his B.S. in International Finance from The American University, Washington, D.C.
Stephane Allard, M.D. has been our Chief Medical Officer since March 2007. Prior to that he
was Chief Executive Officer, President and a Director of Biovest International. Dr. Allard also
served in executive positions at Sanofi-Synthelabo, Synthelabo, Inc. and Lorex Pharmaceuticals.
Dr. Allard received his medical doctorate from Rouen Medical College and received a Diplomate of
CESAM (Certificate of Statistical Studies Applied to Medicine) and a PhD in Clinical Pharmacology
and Pharmacokinetics (Pitie Salpetriere Hospital); Paris, France.
Dileep Bhagwat, Ph.D., has been our Senior Vice President of Pharmaceutical Development since
February 2004 and has more than 25 years of pharmaceutical experience developing and
commercializing various dosage forms. Prior to joining us in 2004, Dr. Bhagwat worked at Bradley
Pharmaceuticals, as Vice President, Research and Development and Chief Scientific Officer. From
November 1994 through September 1999, Dr. Bhagwat was employed at Penwest Pharmaceuticals in
various capacities, including Vice President, Scientific Development and Regulatory Affairs and at
Purdue Frederick Research Center as Assistant Director of Pharmaceutical Development. Dr. Bhagwat
holds many U.S. and foreign patents and has presented and published on dosage form development and
drug delivery. Dr. Bhagwat holds a B.S. in Pharmacy from Bombay University, an M.S. and Ph.D. in
Industrial Pharmacy from St. Johns University in New York and an M.B.A. in International Business
from Pace University in New York.
56
Michael Chen served as our Vice President for Global Business Development from May 2006 to
January 2010. Prior to joining us, Mr. Chen was the Executive Vice President for Sales and
Marketing with the SpyGlass Group, a healthcare consulting firm. From 1995 to 2004, Mr. Chen was
the Executive Director, Worldwide Licensing and Acquisitions for Johnson & Johnson. Prior to that
position, Mr. Chen was the Vice President for Business Development with Synaptic Pharmaceutical
Corporation from 1993 to 1995 and the Director Business Development with CIBA-Geigy from 1985 to
1993. Mr. Chen received his MBA from Harvard Business School, an S.M. in chemical engineering from
the Massachusetts Institute of Technology and a B.S. in chemical engineering (with distinction)
from Cornell University.
Ben Tseng, Ph.D. served as our Chief Scientific Officer from January 2006 to May 2009. Prior
to that he was Vice President, Research, at Maxim. Mr. Tseng joined Maxim as Senior Director,
Research in 2000. Prior to its acquisition by Maxim in 2000, Dr. Tseng served as Vice President,
Biology for Cytovia, Inc., which he joined in 1998. Dr. Tseng also served in executive research
positions at Chugai Biopharmaceutical, Inc. from 1995-1998 and, Genta Inc. from 1989 to 1995. Prior
to joining Genta, Dr. Tseng was a tenured Associate Adjunct Professor in the Department of
Medicine, faculty member of the Physiology and Pharmacology Program, and Associate Member of the
Cancer Center at the University of California, San Diego. Dr. Tseng received a B.A. in Mathematics
from Brandeis University and a Ph.D in Molecular Biophysics and Biochemistry from Yale University.
Bernard R. Tyrrell joined EpiCept as the Senior Vice President, Sales and Marketing in
November 2009. Most recently, Mr. Tyrrell led Otsuka America Pharmaceuticals Oncology Division
in North America. In prior assignments, with leading pharmaceutical companies in the US and EU
including Eli Lilly, Johnson & Johnson and AstraZeneca, and in biotech companies including Oncor
Inc. and Biotechnology General, he lead commercialization efforts for new and existing brands
within multiple specialty therapeutic areas. Mr. Tyrrell lived in the UK for more than 7 years
where he led AstraZenecas Oncology and Infection Global Marketing and launched Eli Lillys
Gemzar. Mr. Tyrrell is a Registered Pharmacist. Mr. Tyrrell earned a BS in Pharmacy from the
Massachusetts College of Pharmacy and holds an MBA in Marketing Management from Bryant College in
Smithfield, Rhode Island.
Board of Directors
Robert G. Savage has been a member of our Board since December 2004 and serves as the Chairman
of the Board. Mr. Savage has been a senior pharmaceutical executive for over twenty years. He held
the position of Worldwide Chairman of the Pharmaceuticals Group at Johnson & Johnson and was both a
company officer and a member of the Executive Committee. He also served Johnson & Johnson in the
capacity of a Company Group Chairman and President of Ortho-McNeil Pharmaceuticals. Most recently,
Mr. Savage was President of the Worldwide Inflammation Group for Pharmacia Corporation and is
presently President and CEO of Strategic Imagery LLC, a consulting company of which he is the
principal. He has held multiple positions leading marketing, business development and strategic
planning at Hoffmann-La Roche and Sterling Drug. Mr. Savage is a director of The Medicines Company,
a specialty pharmaceutical company. Mr. Savage received a B.S. in Biology from Upsala College and
an M.B.A. from Rutgers University. Based on Mr. Savages familiarity with the Company as an
incumbent member of the Companys Board of Directors, his membership on the board of directors of
other public companies and his knowledge of the pharmaceutical industry, the Corporate Governance
and Nominating Committee of the Board of Directors concluded that Mr. Savage has the requisite
experience, qualifications, attributes and skill necessary to serve as a member of the Board of
Directors.
Guy C. Jackson has been a member of our Board since December 2004. In June 2003, Mr. Jackson
retired from the Minneapolis office of the accounting firm of Ernst & Young LLP after 35 years with
the firm and one of its predecessors, Arthur Young & Company. During his career, he served as audit
partner for numerous public companies in Ernst & Youngs New York and Minneapolis offices. Mr.
Jackson also serves as a director and Chairman of the audit committee of Cyberonics, Inc. and
Urologix, Inc., both medical device companies; Digi International Inc., a technology company; and
Life Time Fitness, Inc., an operator of fitness centers. Mr. Jackson received a B.S. in Business
Administration from The Pennsylvania State University and a M.B.A. from the Harvard Business
School. Based on Mr. Jacksons familiarity with the Company as an incumbent member of the Companys
Board of Directors and as the Chairperson of our Audit Committee and his membership on the board of
directors of other public companies, the Corporate Governance and Nominating Committee of the Board
of Directors concluded that Mr. Jackson has the requisite experience, qualifications, attributes
and skill necessary to serve as a member of the Board of Directors.
Gerhard Waldheim has been a member of our board since July 2005. Since 2000, he has co-founded
and built Petersen, Waldheim & Cie. GmbH, Frankfurt, which focuses on private equity and venture
capital fund management, investment banking and related financial advisory services. Biotech and
pharma delivery systems are among the focal points of the funds managed by his firm. Prior to that,
Mr. Waldheim held senior executive and executive board positions with Citibank, RZB Bank Austria,
BfG Bank in Germany and Credit Lyonnais in Switzerland; over the years, his banking focus covered
lending, technology, controlling, investment banking and distressed equity. Prior to that, he
worked for the McKinsey banking practice. He received an MBA from Harvard Business School in 1974
and a JD from the Vienna University School of Law in 1972. Based on Mr. Waldheims
familiarity with the Company as an incumbent member of the Companys Board of Directors and as
a member of our Audit Committee, the Corporate Governance and Nominating Committee of the Board of
Directors concluded that Mr. Waldheim has the requisite experience, qualifications, attributes and
skill necessary to serve as a member of the Board of Directors.
57
Wayne P. Yetter has served as a member of our board of directors since January 2006, and prior
thereto served as a member of Maxims board of directors. From September 2005 to August 2008, Mr.
Yetter was the Chief Executive Officer of Verispan LLC (health care information). From 2003 to 2005
he was the founder of BioPharm Advisory LLC and served on the Advisory Board of Alterity Partners
(mergers and acquisition advisory firm) which is now part of FTN Midwest Securities. From November
2004 to September 2005, Mr. Yetter served as the interim Chief Executive Officer of Odyssey
Pharmaceuticals, Inc., the specialty pharmaceutical division of Pliva d.d. From September 2000 to
June 2003, Mr. Yetter served as Chairman and Chief Executive Officer of Synavant Inc.
(pharmaceutical marketing/technology services). From 1999 to 2000, he served as Chief Operating
Officer at IMS Health, Inc. (information services for the healthcare industry). He also served as
President and Chief Executive Officer of Novartis Pharmaceuticals Corporation, the U.S. Division of
the global pharmaceutical company Novartis Pharma AG, and as President and Chief Executive Officer
of Astra Merck. Mr. Yetter began his career with Pfizer and later joined Merck & Co., holding a
variety of marketing and management positions including Vice President, Marketing Operations,
responsible for global marketing functions and Vice President, Far East and Pacific. Mr. Yetter
serves on the board of directors of InfuSystem Holdings Inc. (a healthcare services company). Based
on Mr. Yetters familiarity with the Company as an incumbent member of the Companys Board of
Directors and as a member of our Audit Committee, his prior membership on the board of directors of
other public companies and his knowledge of the pharmaceutical industry, the Corporate Governance
and Nominating Committee of the Board of Directors concluded that Mr. Yetter has the requisite
experience, qualifications, attributes and skill necessary to serve as a member of the Board of
Directors.
A. Collier Smyth, M.D. has served as a member of our board of directors since April 2009,
following his retirement from Bristol-Myers Squibb Company, or BMS, where he served as Senior Vice
President of Medical Strategy, Oncology. Prior to his recent retirement from BMS, Dr. Smyth led
oncology medical affairs in the United States, including the U. S. life-cycle development of
paclitaxel (Taxol®), carboplatin (Paraplatin®) and ifosfamide (Ifex®). Most recently, he
participated in the launch of multiple BMS oncology drugs, including cetuximab (Erbitux®),
dasatinib (Sprycel®) and ixabepilone (Ixempra®). During his thirteen-year tenure with BMS, Dr.
Smyth oversaw key aspects of medical strategy, medical liaison, medical information, clinical
operations, regulatory affairs, quality assurance and compliance in the oncology division of BMS.
At times, medical affairs for virology and immunoscience were added to his oncology
responsibilities. Prior to joining BMS, Dr. Smyth served as vice president of medical affairs with
American Oncology Resources, Inc., now U.S. Oncology, where he was responsible for establishing the
strategic priorities of the countrys largest oncology physician group practice. Previously, Dr.
Smyth was the founder and president of New Hampshire Oncology/Hematology, the first office-based
medical oncology practice in New Hampshire. Dr. Smyth also serves on the Board of Directors of
Ariad Pharmaceuticals, Inc. Based on Dr. Smyths knowledge of oncology and the pharmaceutical industry and his
familiarity with the Company as an incumbent member of the Companys Board of Directors, the
Corporate Governance and Nominating Committee of the Board of Directors concluded that Dr. Smyth
has the requisite experience, qualifications, attributes and skill necessary to serve as a member
of the Board of Directors.
Board Composition and Leadership Structure
Our board of directors is divided into three classes, with each director serving a three-year
term and one class being elected at each years annual meeting of stockholders. A majority of the
members of our board of directors are independent of us and our management. Directors Jackson and
Yetter are in the class of directors whose term expires at the 2012 annual meeting of stockholders.
Directors Waldheim and Smyth is in the class of directors whose term expires at the 2010 annual
meeting of stockholders. Directors Talley and Savage are in the class of directors whose term
expires at the 2011 annual meeting of stockholders.
Mr. Savage is the Chairman of the Board. Our Chief Executive Officer, Mr. Talley, serves as a
director, though he is not a member of any standing committees of the board.
Meetings and Meeting Attendance
During the fiscal year ended December 31, 2009, there were 14 meetings of the board of
directors. All incumbent directors attended 75% or more of the Board meetings and meetings of the
committees on which they served during the last fiscal year. Directors are encouraged to attend the
annual meeting of stockholders. All directors attended the 2009 annual meeting of stockholders.
58
Committees of the Board
Our board of directors has established three standing committees: the audit committee, the
compensation committee and the corporate governance and nominating committee. Each standing
committee has a charter, accessible on our website at http://www.epicept.com, or by sending a
request in writing to EpiCept Corporation, 777 Old Saw Mill River Road, Tarrytown, New York 10591,
Attention: Robert W. Cook. Our website, and the information contained in our website, is not part
of this Annual Report on Form 10-K.
Audit Committee. Our Audit Committee is responsible for the oversight of such reports,
statements or charters as may be required by The Nasdaq Capital Market, The Nasdaq OMX Stockholm
Exchange or federal securities laws, as well as, among other things:
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overseeing and monitoring the integrity of our consolidated financial statements, our
compliance with legal and regulatory requirements as they relate to financial statements
or accounting matters, and our internal accounting and financial controls and risk
management (with the persons who supervise risk management reporting directly to the
committee); |
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preparing the report that SEC rules require be included in our annual proxy
statement; |
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overseeing and monitoring our independent registered public accounting firms
qualifications, independence and performance; |
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providing the board with the results of our monitoring and recommendations; and |
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providing to the board additional information and materials as it deems necessary to
make the board aware of significant financial matters that require the attention of the
board. |
Messrs. Jackson, Waldheim and Yetter are currently members of the audit committee, each of
whom is a non-employee member of the board of directors. Mr. Jackson serves as Chairman of the
Audit Committee and also qualifies as an audit committee financial expert, as that term is
defined under the SEC rules implementing Section 407 of the Sarbanes-Oxley Act. The board has
determined that each member of our audit committee meets the current independence and financial
literacy requirements under the Sarbanes-Oxley Act, the Nasdaq Capital Market and SEC rules and
regulations. We intend to comply with future requirements to the extent they become applicable to
us.
Compensation Committee. Our Compensation Committee is composed of Messrs. Savage, Smyth and
Jackson, all of whom are a non-employee member of our board of directors. Mr. Savage serves as
Chairman of our Compensation Committee. Each member of our Compensation Committee is an outside
director as that term is defined in Section 162(m) of the Internal Revenue Code of 1986 and a
non-employee director within the meaning of Rule 16b-3 of the rules promulgated under the
Exchange Act and the rules of The Nasdaq Capital Market. The Compensation Committee is responsible
for, among other things:
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reviewing and approving for the chief executive officer and other executive officers
(a) the annual base salary, (b) the annual incentive bonus, including the specific goals
and amount, (c) equity compensation, (d) employment agreements, severance arrangements
and change in control arrangements, and (e) any other benefits, compensations,
compensation policies or arrangements; |
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reviewing and making recommendations to the board regarding the compensation policy
for such other officers as directed by the board; |
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preparing a report to be included in the annual proxy statement that describes: (a)
the criteria on which compensation paid to the chief executive officer for the last
completed fiscal year is based; (b) the relationship of such compensation to our
performance; and (c) the committees executive compensation policies applicable to
executive officers; and |
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acting as administrator of our current benefit plans and making recommendations to
the board with respect to amendments to the plans, changes in the number of shares
reserved for issuance thereunder and regarding other benefit plans proposed for
adoption. |
59
Corporate Governance and Nominating Committee. Our Corporate Governance and Nominating
Committee is composed of Messrs. Yetter, Savage and Waldheim, each of whom is a non-employee member
of the board of directors and independent in
accordance with the applicable rules of the Sarbanes-Oxley Act and the Nasdaq Capital Market.
Mr. Yetter serves as chairman of the Corporate Governance and Nominating Committee. The Corporate
Governance and Nominating Committee is responsible for, among other things:
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reviewing board structure, composition and practices, and making recommendations on
these matters to the board; |
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reviewing, soliciting and making recommendations to the board and stockholders with
respect to candidates for election to the board; |
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overseeing compliance by the chief executive officer and senior financial officers with
the Code of Ethics for the Chief Executive Officer and Senior Financial Officers; and |
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overseeing compliance by employees with the Code of Business Conduct and Ethics. |
In making its recommendations to the board, the committee considers, among other things, the
qualifications of individual director candidates. While the committee has no specific policy with
regard to the consideration of diversity in identifying director candidates, the committee works
with the board to determine the appropriate characteristics, skills, and experiences for the board
as a whole and its individual members with the objective of having a board with diverse backgrounds
and experience in business, finance, and medicine. Characteristics expected of all directors
include independence, integrity, high personal and professional ethics, sound business judgment,
and the ability and willingness to commit sufficient time to the board. In evaluating the
suitability of individual board members, the board takes into account many factors, including
general understanding of marketing, finance, and other disciplines relevant to the success of a
publicly traded company in todays business environment; understanding of our business and
technology; educational and professional background; personal accomplishment; and geographic,
gender, age, and diversity. The board evaluates each individual in the context of the board as a
whole, with the objective of recommending a group that can best perpetuate the success of our
business and represent stockholder interests through the exercise of sound judgment using its
diversity of experience. In determining whether to recommend a director for re-election, the
committee also considers the directors past attendance at meetings, participation in and
contributions to the activities of the board, and the results of the most recent board
self-evaluation. The Corporate Governance and Nominating Committee will consider director
candidates recommended by stockholders submitted in accordance with our by-laws.
The information contained in this Annual Report on Form 10-K with respect to the charters of
each of the Audit Committee, the Compensation Committee, and the Nominating and Corporate
Governance Committee and the independence of the non-management members of the Board of Directors
shall not be deemed to be soliciting material or to be filed with the SEC, nor shall the
information be incorporated by reference into any future filing under the Securities Act of 1933 or
the Securities Exchange Act of 1934, except to the extent that we specifically incorporate it by
reference in a filing. Our website, and the information contained in our website, is not a part of
this Annual Report on Form 10-K.
Code of Ethics
We have adopted a Code of Business Conduct and Ethics that applies to all our employees, and a
Supplemental Code of Ethics that specifically applies to chief executive officer and chief
financial officer. This Code of Ethics is designed to comply with the Nasdaq marketplace rules
related to codes of conduct. A copy of this Supplemental Code of Ethics may be obtained on our
website at http://www.epicept.com. We intend to post on our website any amendments to, or waiver
from, our Code of Business Conduct and Ethics or our Supplemental Code of Ethics for the benefit of
our principal executive officer, principal financial officer, principal accounting officer or
controller, or persons performing a similar function, and other named executives. Our website, and
the information contained in our website, is not a part of this Annual Report on Form 10-K.
Section 16(a) Beneficial Ownership Reporting Compliance
No person who, during the fiscal year ended December 31, 2009, was a Reporting Person
defined as a director, officer or beneficial owner of more than ten percent of the our common stock
which is the only class of securities of the Company registered under Section 12 of the Exchange
Act, failed to file on a timely basis reports required by Section 16 of the Exchange Act during the
most recent fiscal year. The foregoing is based solely upon a review by us of Forms 3 and 4 during
the most recent fiscal year as furnished to us under Rule 16a-3(d) under the Exchange Act, and
Forms 5 and amendments thereto furnished to the Company with respect to its most recent fiscal
year, and any representation received by us from any reporting person that no Form 5 is required.
60
ITEM 11. EXECUTIVE COMPENSATION
Compensation Discussion and Analysis
The following discussion and analysis of compensation arrangements of our named executive
officers for the year ended December 31, 2009 should be read together with the compensation tables
and related disclosures set forth below. This discussion contains forward looking statements that
are based on our current plans, considerations, expectations and determinations regarding future
compensation programs. Actual compensation programs that we adopt may differ materially from
currently planned programs as summarized in this discussion.
Role of the Compensation Committee
Our executive compensation is administered by the Compensation Committee of the Board of
Directors. The members of this committee are Robert G. Savage (Chairman), A. Collier Smyth and Guy C. Jackson, each
an independent, non-employee director. In 2009, the Compensation Committee met eight times and all
of the members of the Compensation Committee were present during each meeting.
Under the terms of its Charter, the Compensation Committee is responsible for delivering the
type and level of compensation to be granted to our executive officers. In fulfilling its role, the
Compensation Committee reviews and approves for the Chief Executive Officer (CEO) and other
executive officers: (1) the annual base salary, (2) the annual incentive bonus, including the
specific goals and amounts, (3) equity compensation, (4) employment agreements, severance
arrangements and change in control arrangements and (5) any other benefits, compensation,
compensation policies or arrangements.
All new employee equity grants, subsequent grants to existing employees and any grant to
executive officers are approved by the Compensation Committee.
While management may use consultants to assist in the evaluation of the CEO or executive
officer compensation, the Compensation Committee has authority to retain its own compensation
consultant, as it sees fit. The Compensation Committee also has the authority to obtain advice and
assistance from internal or external legal, accounting or other advisors.
During 2009, the Compensation Committee retained Radford, an Aon Consulting Company, or Radford, to provide compensation information.
The Compensation Committee received compensation recommendations from the CEO,
relevant background information on our executive officers and compensation studies conducted by
Radford. The Compensation Committee then reviewed the compensation recommendation with the CEO for
all executives, except for the CEO. The CEO was not present during the discussion of his
compensation. The Compensation Committee then determined the compensation levels for the executive
officers and reported that determination to the Board.
Compensation Objectives Philosophy
The primary objectives of the Compensation Committee with respect to executive compensation
are to attract and retain the most talented and dedicated executives possible, to tie annual cash
bonuses and long-term equity incentives to achievement of performance objectives, and to align
executives incentives with stockholder value creation. To achieve these objectives, the
Compensation Committee implements and maintains compensation plans that tie a substantial portion
of executive officers overall compensation to (i) operational goals such as meeting
operating plans and budgets, review of organization and staff and the implementation of requisite
changes, (ii) strategic goals such as the establishment and maintenance of key strategic
relationships, the development of our product candidates and the identification and advancement of
additional product candidates and (iii) financial factors, such as success in raising capital and
improving our results of operations. The Compensation Committee evaluates individual executive
performance with the goal of setting compensation at levels the Compensation Committee believes are
comparable with executives in other companies of similar size and stage of development operating in
the biotechnology and specialty pharmaceutical industries while taking into account our relative
performance and our own strategic goals.
Compensation Program
In order to achieve the above goals, our total compensation packages include base salary and
annual bonus, all paid in cash, as well as long-term compensation in the form of stock options,
restricted stock and/or restricted stock units. We believe that appropriately balancing the total
compensation package is necessary in order to provide market-competitive compensation. The costs of
our compensation programs are a significant determinant of our competitiveness. Accordingly, we are
focused on ensuring
that the balance of the various components of our compensation program is optimized to
motivate employees to achieve our corporate objectives on a cost-effective basis.
61
Review of External Data.
The Compensation Committee obtained a survey of the compensation practices of our peers in the
United States in order to assess the competitiveness of our executive compensation. In the fourth
quarter of 2009, the Compensation Committee obtained data from Radford for a number of
biotechnology and specialty pharmaceutical companies with less than $50.0 million in revenue,
comparable numbers of employees, comparable market capitalization and/or similar product offerings
(the general peer group). The peer group consists of Adolor Corporation, Anesiva, Inc., A.P.
Pharma, Inc., Ariad Pharmaceuticals, Inc., BioCryst Pharmaceuticals, Inc., Cell Therapeutics, Inc.,
Depomed, Inc., Durect Corporation, Genta, Inc., Nastech Pharmaceutical Company, Inc., NeoPharm,
Inc., Novacea, Inc., NPS Pharmaceuticals, Inc., Oxigene, Inc., Pain Therapeutics, Inc., Pozen, Inc.
and Titan Pharmaceuticals, Inc. The Compensation Committee asked Radford to conduct assessments in
three areas of compensation for executive positions: 1) total direct compensation (base salary) for
our executive officers; 2) target total cash compensation (salary and bonus); and 3) equity grants.
For executive officers, we targeted the aggregate value of our total cash compensation (base
salary and bonus) near the 50th percentile of the general peer group and long-term equity incentive
compensation near the 75th percentile. The Compensation Committee strongly believes in engaging the
best talent in critical functions, and this may entail negotiations with individual executives who
may have significant retention packages in place with other employers. In order to attract such
individuals to our Company, the Compensation Committee may determine that it is in our best
interests to negotiate packages that deviate from the general principle of benchmarking our
compensation on our general peer group. Similarly, the Compensation Committee may determine to
provide compensation outside of the normal cycle to individuals to address retention issues.
Compensation Elements
Cash Compensation
Base Salary. Base salaries for our executive officers are established based on the scope of
their responsibilities, taking into account competitive market compensation paid by other benchmark
companies for similar positions. Generally, we believe that executive base salaries should be
targeted near the 50th percentile of the range of salaries for executives in similar positions with
similar responsibilities at our peer group companies, in line with our compensation philosophy.
Base salaries are reviewed by the Compensation Committee annually, and adjusted from time to time
to realign salaries with market levels after taking into account individual responsibilities,
performance and experience. This review generally occurs each year in the fourth quarter for
implementation in the first quarter.
Annual Bonus. The Compensation Committee has the authority to award annual bonuses to our
executive officers and other key employees. The Compensation Committee reviews potential annual
cash incentive awards for our named executive officers annually to determine award payments, if
any, for the last completed fiscal year, as well as to establish award opportunities for the
current year. The Compensation Committee intends to utilize annual incentive bonuses to compensate
executive officers for achieving financial and operational goals and for achieving individual
annual performance objectives. These objectives will vary depending on the individual executive
officer, but will relate generally to (i) operational goals such as those related to operating
plans and budgets, review of organization and staff and the implementation of requisite changes,
(ii) strategic goals such as the establishment and maintenance of key strategic relationships, the
development of our product candidates and the identification and advancement of additional product
candidates and (iii) financial factors, such as success in raising capital and our results of
operations. The Compensation Committee evaluates individual executive performance with the goal of
setting compensation at levels the Compensation Committee believes, based on the Radford survey,
are comparable with executive officers in other companies of similar size and stage of development
operating in the biotechnology and specialty pharmaceutical industries while taking into account
our relative performance and our own strategic goals. In 2009, the Compensation Committee awarded
bonuses to certain of our executive officers. The Compensation Committee also has the ability to
grant discretionary bonuses to executive officers. No discretionary bonuses were granted in 2009.
62
For 2009, annual cash bonus award opportunities for the named executive officers are
summarized below. These awards were determined and paid in 2010 and, accordingly, they are not
reflected in the summary compensation table.
Annual Cash Bonus Award Opportunity
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Target Performance |
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|
|
|
|
|
|
% of Salary |
|
|
Amount |
|
|
Amount Paid |
|
Jack Talley |
|
FY 2009 |
|
|
55 |
|
|
$ |
239,250 |
|
|
$ |
119,625 |
|
Robert Cook |
|
FY 2009 |
|
|
30 |
|
|
|
83,120 |
|
|
|
81,120 |
|
Stephane Allard |
|
FY 2009 |
|
|
30 |
|
|
|
81,000 |
|
|
|
93,150 |
|
Ben Tseng (1) |
|
FY 2009 |
|
|
30 |
|
|
|
81,000 |
|
|
|
|
|
Dileep Bhagwat |
|
FY 2009 |
|
|
30 |
|
|
|
81,000 |
|
|
|
68,850 |
|
|
|
|
(1) |
|
Ben Tseng served as our Chief Scientific Officer from January 2006 to May 2009. |
Long-Term Incentive Program
We believe that long-term performance is achieved through an ownership culture that encourages
such performance by our executive officers through the use of stock and stock-based awards. Our
equity plans have been established to provide our employees, including our executive officers, with
incentives to help align those employees interests with the interests of stockholders. The
Compensation Committee believes that the use of stock and stock-based awards offers the best
approach to achieving our compensation goals. We have historically elected to use stock options as
the primary long-term equity incentive vehicle. We believe that the annual aggregate value of these
awards should be set near the 75th percentile of our general peer group. Due to the early stage of
our business, our desire to preserve cash, and the limited nature of our retirement benefit plans,
we expect to provide a greater portion of total compensation to our executives through stock
options, restricted stock units and restricted stock grants than through cash-based compensation.
Stock Options Our stock plans authorize us to grant options to purchase shares of common stock
to our employees, directors and consultants. Our Compensation Committee oversees the administration
of our stock option plan. Stock options may be granted at the commencement of employment, annually,
occasionally following a significant change in job responsibilities or to meet other special
retention objectives.
We expect to continue to use stock options as a long-term incentive vehicle because:
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|
Stock options align the interests of executives with those of the stockholders, support
a pay-for-performance culture, foster employee stock ownership, and focus the management
team on increasing value for the stockholders. |
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|
Stock options are performance based, in that any value received by the recipient of a
stock option is based on the growth of the stock price. |
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|
Stock options help to provide a balance to the overall executive compensation program as
base salary and our discretionary annual bonus program focus on short-term compensation,
while the vesting of stock options increases stockholders value over the longer term. |
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|
The vesting period of stock options encourages executive retention and the preservation
of stockholder value. In determining the number of stock options to be granted to
executives, we take into account the individuals position, scope of responsibility,
ability to affect profits and stockholders value and the individuals historic and recent
performance and the value of stock options in relation to other elements of the individual
executives total compensation. |
The Compensation Committee reviews and approves stock option awards to executive officers
based upon a review of competitive compensation data, its assessment of individual performance, a
review of each executives existing long-term incentives, and retention considerations. Periodic
stock option grants are made at the discretion of the Compensation Committee to eligible employees
and, in appropriate circumstances, the Compensation Committee considers the recommendations of our
CEO.
In 2009, certain named executive officers were awarded stock options in the amounts indicated
in the section entitled Option Grants in Last Fiscal Year (2009). These grants included grants
made in January 2009 in connection with merit-based grants made by the Board of Directors to
certain of our executive officers, which were intended to encourage an ownership culture among our
executive officers. The January 2009 grants were also made to certain of our executive officers
based on performance of such
executive officers and to reward our executive officers for their service and to encourage
continued service with us. Stock options granted by us have an exercise price equal to the fair
market value of our common stock on the day of grant, typically vest monthly over a four-year
period based upon continued employment, and generally expire ten years after the date of grant.
63
Stock Appreciation Rights Our 2005 equity incentive plan authorizes us to grant stock
appreciation rights, or SARs. To date, we have not granted any SAR under our 2005 equity incentive
plan. A SAR represents a right to receive the appreciation in value, if any, of our common stock
over the base value of the SAR. The base value of each SAR equals the value of our common stock on
the date the SAR is granted. Upon surrender of each SAR, unless we elect to deliver common stock,
we will pay an amount in cash equal to the value of our common stock on the date of delivery over
the base price of the SAR. SARs typically vest based upon continued employment on a pro-rata basis
over a four-year period, and generally expire ten years after the date of grant. Our Compensation
Committee is the administrator of our stock appreciation rights plan.
Restricted Stock and Restricted Stock Units Our 2005 equity incentive plan authorizes us to
grant restricted stock and restricted stock units. In 2009, certain named non-employee directors were granted
14,375 restricted stock units with an aggregate fair market value of $31,000. In order to implement
our long-term incentive goals, we may grant restricted stock units in the future in conjunction
with stock options.
Other Compensation
Our executive officers, who are parties to employment agreements, will continue to be parties
to such employment agreements in their current form until such time as the Compensation Committee
determines in its discretion that revisions to such employment agreements are advisable. In
addition, consistent with our compensation philosophy, we intend to continue to maintain our
current benefits for our executive officers, including medical, dental, vision and life insurance
coverage and the ability to contribute to a 401(k) retirement plan; however, the Compensation
Committee in its discretion may revise, amend or add to the officers executive benefits if it
deems it advisable. We believe these benefits are currently comparable to the median competitive
levels for comparable companies.
64
Executive Compensation
The following table sets forth the compensation earned for services rendered to us in all
capacities by our chief executive officer and certain executive officers whose total cash
compensation exceeded $100,000 for the year ended December 31, 2009, collectively referred to in
this annual report as the named executive officers.
Summary Compensation Table
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Change in |
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|
pension |
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|
value and |
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|
nonqualified |
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|
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|
|
|
|
|
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Non-Equity |
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|
deferred |
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|
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|
Stock |
|
|
Option |
|
|
Incentive Plan |
|
|
compensation |
|
|
All Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salary |
|
|
Bonus |
|
|
Awards |
|
|
Awards |
|
|
Compensation |
|
|
earnings |
|
|
Compensation |
|
|
Total |
|
|
|
|
|
Name/Principal Position |
|
Year |
|
|
($) |
|
|
($)(1) |
|
|
($)(2) |
|
|
($)(3) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
|
|
|
John V. Talley |
|
|
2009 |
|
|
|
435,000 |
|
|
|
358,875 |
|
|
|
|
|
|
|
345,573 |
|
|
|
|
|
|
|
|
|
|
|
37,175 |
(4) |
|
|
1,176,623 |
|
President and |
|
|
2008 |
|
|
|
435,000 |
|
|
|
200,000 |
|
|
|
117,250 |
|
|
|
329,378 |
|
|
|
|
|
|
|
|
|
|
|
37,776 |
(4) |
|
|
1,119,404 |
|
Chief Executive Officer |
|
|
2007 |
|
|
|
400,000 |
|
|
|
175,000 |
|
|
|
99,525 |
|
|
|
278,943 |
|
|
|
|
|
|
|
|
|
|
|
49,685 |
(4) |
|
|
1,003,153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert W. Cook |
|
|
2009 |
|
|
|
270,400 |
|
|
|
81,120 |
|
|
|
|
|
|
|
93,039 |
|
|
|
|
|
|
|
|
|
|
|
20,202 |
(5) |
|
|
464,761 |
|
Chief Financial Officer, |
|
|
2008 |
|
|
|
270,400 |
|
|
|
65,000 |
|
|
|
42,746 |
|
|
|
114,378 |
|
|
|
|
|
|
|
|
|
|
|
15,891 |
(5) |
|
|
508,415 |
|
Senior Vice President Finance & Administration |
|
|
2007 |
|
|
|
260,000 |
|
|
|
46,875 |
|
|
|
22,995 |
|
|
|
63,451 |
|
|
|
|
|
|
|
|
|
|
|
24,657 |
(5) |
|
|
417,978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephane Allard |
|
|
2009 |
|
|
|
270,000 |
|
|
|
121,500 |
|
|
|
|
|
|
|
106,330 |
|
|
|
|
|
|
|
|
|
|
|
20,788 |
(5) |
|
|
518,618 |
|
Chief Medical Officer |
|
|
2008 |
|
|
|
270,000 |
|
|
|
52,083 |
|
|
|
42,746 |
|
|
|
145,816 |
|
|
|
|
|
|
|
|
|
|
|
16,476 |
(5) |
|
|
527,121 |
|
|
|
|
2007 |
|
|
|
213,182 |
|
|
|
|
|
|
|
|
|
|
|
113,797 |
|
|
|
|
|
|
|
|
|
|
|
15,136 |
(5) |
|
|
342,115 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dileep Bhagwat |
|
|
2009 |
|
|
|
270,000 |
|
|
|
121,500 |
|
|
|
|
|
|
|
106,330 |
|
|
|
|
|
|
|
|
|
|
|
26,724 |
(5) |
|
|
524,554 |
|
Senior Vice President, |
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|
2008 |
|
|
|
270,000 |
|
|
|
93,750 |
|
|
|
42,746 |
|
|
|
145,816 |
|
|
|
|
|
|
|
|
|
|
|
26,476 |
(5) |
|
|
578,788 |
|
Pharmaceutical Development |
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|
2007 |
|
|
|
250,000 |
|
|
|
57,200 |
|
|
|
34,482 |
|
|
|
97,612 |
|
|
|
|
|
|
|
|
|
|
|
25,813 |
(5) |
|
|
465,107 |
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Chen |
|
|
2009 |
|
|
|
237,000 |
|
|
|
35,550 |
|
|
|
|
|
|
|
39,874 |
|
|
|
|
|
|
|
|
|
|
|
21,816 |
(5) |
|
|
334,240 |
|
Vice President Business |
|
|
2008 |
|
|
|
237,000 |
|
|
|
28,750 |
|
|
|
16,750 |
|
|
|
57,105 |
|
|
|
|
|
|
|
|
|
|
|
17,504 |
(5) |
|
|
357,109 |
|
Development |
|
|
2007 |
|
|
|
230,000 |
|
|
|
23,200 |
|
|
|
17,476 |
|
|
|
48,222 |
|
|
|
|
|
|
|
|
|
|
|
22,736 |
(5) |
|
|
341,634 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ben Tseng (6) |
|
|
2009 |
|
|
|
276,711 |
|
|
|
81,000 |
|
|
|
|
|
|
|
34,898 |
|
|
|
|
|
|
|
|
|
|
|
28,215 |
(5) |
|
|
420,824 |
|
Chief Scientific Officer |
|
|
2008 |
|
|
|
270,000 |
|
|
|
62,500 |
|
|
|
42,746 |
|
|
|
145,816 |
|
|
|
|
|
|
|
|
|
|
|
27,978 |
(5) |
|
|
549,040 |
|
|
|
|
2007 |
|
|
|
250,000 |
|
|
|
43,000 |
|
|
|
26,525 |
|
|
|
75,086 |
|
|
|
|
|
|
|
|
|
|
|
27,210 |
(5) |
|
|
421,821 |
|
|
|
|
(1) |
|
Annual cash bonus awards are determined and paid based on the executives performance during
the previous year. |
|
(2) |
|
This column represents the grant date fair values for restricted stock granted in 2007 and
restricted stock units granted in 2008 to the named executive officers. The 2007 and 2008
stock award values were recalculated from amounts shown in prior annual reports on Form 10-K
to reflect their grant date fair values, as required by SEC rules effective for 2010. The
grant date fair values have been determined based on the assumptions and methodologies set
forth in the Companys 2009 Annual Report on Form 10-K (Note 11, Share-Based Payments). |
|
(3) |
|
This column represents the grant date fair values of the stock options awarded in 2009, 2008
and 2007, respectively, The 2007 and 2008 option award values were recalculated from the
amounts shown in prior annual reports on Form 10-K to reflect the grant date fair value, as
required by SEC rules effective for 2010. The grant date fair values have been determined
based on the assumptions and methodologies set forth in the Companys 2009 Annual Report (Note
11, Share-Based Payments). |
|
(4) |
|
Includes premiums for health benefits, life and disability insurance and automobile allowance
paid on behalf of Mr. Talley. |
|
(5) |
|
Includes premiums for health benefits and for life and disability insurance paid on behalf of
the named executive officer. |
|
(6) |
|
Ben Tseng served as our Chief Scientific Officer from January 2006 to May 2009.
During 2009, Dr. Tseng received a salary of $112,500, a lump-sum payment of $29,211 for
accrued but unused vacation days and severance payments of $135,000 per his employment
agreement. |
65
Option Grants in Last Fiscal Year (2009)
During 2009, the Company granted approximately 0.7 million stock options and restricted stock
units to employees and directors, of which approximately 0.5 million were to the below named
executive officers.
Grants of Plan-Based Awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
All Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Awards: |
|
|
Option |
|
|
|
|
|
|
Grant Date |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number |
|
|
Awards: |
|
|
Exercise |
|
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
of |
|
|
Number |
|
|
Price of |
|
|
of |
|
|
|
|
|
|
|
Estimated Future Payouts Under |
|
|
Estimated Future Payouts Under |
|
|
Shares |
|
|
of Shares |
|
|
Option |
|
|
Stock and |
|
|
|
|
|
|
|
Non-Equity Incentive Plan Awards |
|
|
Equity Incentive Plan Awards |
|
|
of Stock |
|
|
Underlying |
|
|
Awards |
|
|
Option |
|
Name |
|
Grant Date |
|
|
Threshold |
|
|
Target |
|
|
Maximum |
|
|
Threshold |
|
|
Target |
|
|
Maximum |
|
|
or Units |
|
|
Options |
|
|
(1) |
|
|
Awards (2) |
|
John V. Talley |
|
|
01/05/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
108,334 |
|
|
$ |
1.89 |
|
|
$ |
151,216 |
|
|
|
|
02/20/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
140,834 |
|
|
$ |
1.68 |
|
|
$ |
194,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert W. Cook |
|
|
01/05/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
29,167 |
|
|
$ |
1.89 |
|
|
$ |
40,712 |
|
|
|
|
02/20/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
37,917 |
|
|
$ |
1.68 |
|
|
$ |
52,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephane Allard |
|
|
01/05/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
33,334 |
|
|
$ |
1.89 |
|
|
$ |
46,530 |
|
|
|
|
02/20/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
43,334 |
|
|
$ |
1.68 |
|
|
$ |
59,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dileep Bhagwat |
|
|
01/05/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
33,334 |
|
|
$ |
1.89 |
|
|
$ |
46,530 |
|
|
|
|
02/20/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
43,334 |
|
|
$ |
1.68 |
|
|
$ |
59,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Chen |
|
|
01/05/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
12,500 |
|
|
$ |
1.89 |
|
|
$ |
17,449 |
|
|
|
|
02/20/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
16,250 |
|
|
$ |
1.68 |
|
|
$ |
22,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ben Tseng |
|
|
01/05/2009 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
25,000 |
|
|
$ |
1.89 |
|
|
$ |
34,898 |
|
|
|
|
(1) |
|
The exercise price of the options was equal to the market value of our common stock on
the date of the grant. |
|
|
|
(2) |
|
The grant date fair values have been determined based on the assumptions and
methodologies set forth in the Companys 2009 Annual Report
(Note 11, Share-Based Payments). |
Aggregate Option Exercises in Last Fiscal Year (2009) and Values at December 31, 2009
None of the named executive officers exercised any options in 2009. The named executive
officers in the Grants of Plan-Based Awards Table above received an aggregate of 10,586 shares of
common stock representing the vested portion of their restricted stock grant in 2007.
66
Outstanding Equity Awards at December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Awards |
|
|
Stock Awards |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Incentive |
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Incentive Plan |
|
|
Plan Awards: |
|
|
|
|
|
|
|
|
|
|
|
Incentive Plan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Market |
|
|
Awards: |
|
|
Market or |
|
|
|
|
|
|
|
|
|
|
|
Awards: |
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Value of |
|
|
Number of |
|
|
Payout Value of |
|
|
|
Number of Securities |
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
Shares or |
|
|
Shares or |
|
|
Unearned |
|
|
Unearned |
|
|
|
Underlying |
|
|
Securities |
|
|
|
|
|
|
|
|
|
|
Units of |
|
|
Units of |
|
|
Shares, Units or |
|
|
Shares, Units or |
|
|
|
Unexercised Options |
|
|
Underlying |
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
Stock |
|
|
Other Rights |
|
|
Other Rights |
|
|
|
Number |
|
|
Number |
|
|
Unexercised Unearned |
|
|
Option |
|
|
Option |
|
|
That have |
|
|
That have |
|
|
That have |
|
|
That have |
|
Name |
|
Exercisable |
|
|
Unexercisable |
|
|
Options |
|
|
Exercise Price |
|
|
Expiration Date |
|
|
Not Vested |
|
|
Not Vested |
|
|
Not Vested |
|
|
Not Vested |
|
John V. Talley |
|
|
27,695 |
|
|
|
|
|
|
|
|
|
|
$ |
3.60 |
|
|
|
11/1/2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
695 |
|
|
|
|
|
|
|
|
|
|
$ |
3.60 |
|
|
|
1/1/2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,778 |
|
|
|
|
|
|
|
|
|
|
$ |
3.60 |
|
|
|
1/1/2012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
414,219 |
|
|
|
|
|
|
|
|
|
|
$ |
17.52 |
|
|
|
1/4/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
68,416 |
|
|
|
22,806 |
|
|
|
|
|
|
$ |
4.38 |
|
|
|
1/8/2017 |
|
|
|
5,680 |
|
|
$ |
9,883 |
|
|
|
|
|
|
|
|
|
|
|
|
58,332 |
|
|
|
58,335 |
|
|
|
|
|
|
$ |
4.02 |
|
|
|
1/7/2018 |
|
|
|
29,167 |
|
|
$ |
50,750 |
|
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
$ |
1.89 |
|
|
|
9/8/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,081 |
|
|
|
81,253 |
|
|
|
|
|
|
$ |
1.89 |
|
|
|
1/5/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
140,834 |
|
|
|
|
|
|
$ |
1.68 |
|
|
|
2/20/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert Cook |
|
|
70,523 |
|
|
|
|
|
|
|
|
|
|
$ |
17.52 |
|
|
|
1/4/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,563 |
|
|
|
5,187 |
|
|
|
|
|
|
$ |
4.38 |
|
|
|
1/8/2017 |
|
|
|
1,312 |
|
|
$ |
2,283 |
|
|
|
|
|
|
|
|
|
|
|
|
21,283 |
|
|
|
21,284 |
|
|
|
|
|
|
$ |
4.02 |
|
|
|
1/7/2018 |
|
|
|
10,634 |
|
|
$ |
18,500 |
|
|
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
$ |
1.89 |
|
|
|
9/8/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,291 |
|
|
|
21,876 |
|
|
|
|
|
|
$ |
1.89 |
|
|
|
1/5/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,917 |
|
|
|
|
|
|
$ |
1.68 |
|
|
|
2/20/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephane Allard |
|
|
23,611 |
|
|
|
9,723 |
|
|
|
|
|
|
$ |
4.89 |
|
|
|
3/23/2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,283 |
|
|
|
21,284 |
|
|
|
|
|
|
$ |
4.02 |
|
|
|
1/7/2018 |
|
|
|
10,634 |
|
|
$ |
18,500 |
|
|
|
|
|
|
|
|
|
|
|
|
16,667 |
|
|
|
|
|
|
|
|
|
|
$ |
1.89 |
|
|
|
9/8/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,333 |
|
|
|
25,001 |
|
|
|
|
|
|
$ |
1.89 |
|
|
|
1/5/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,334 |
|
|
|
|
|
|
$ |
1.68 |
|
|
|
2/20/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dileep Bhagwat |
|
|
37,500 |
|
|
|
|
|
|
|
|
|
|
$ |
17.52 |
|
|
|
1/4/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,941 |
|
|
|
7,981 |
|
|
|
|
|
|
$ |
4.38 |
|
|
|
1/8/2017 |
|
|
|
1,968 |
|
|
$ |
3,424 |
|
|
|
|
|
|
|
|
|
|
|
|
21,283 |
|
|
|
21,284 |
|
|
|
|
|
|
$ |
4.02 |
|
|
|
1/7/2018 |
|
|
|
10,634 |
|
|
$ |
18,500 |
|
|
|
|
|
|
|
|
|
|
|
|
16,667 |
|
|
|
|
|
|
|
|
|
|
$ |
1.89 |
|
|
|
9/8/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,333 |
|
|
|
25,001 |
|
|
|
|
|
|
$ |
1.89 |
|
|
|
1/5/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,334 |
|
|
|
|
|
|
$ |
1.68 |
|
|
|
2/20/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ben Tseng |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Chen |
|
|
24,445 |
|
|
|
2,222 |
|
|
|
|
|
|
$ |
8.10 |
|
|
|
5/26/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,828 |
|
|
|
3,942 |
|
|
|
|
|
|
$ |
4.38 |
|
|
|
1/8/2017 |
|
|
|
996 |
|
|
$ |
1,733 |
|
|
|
|
|
|
|
|
|
|
|
|
8,333 |
|
|
|
8,334 |
|
|
|
|
|
|
$ |
4.02 |
|
|
|
1/7/2018 |
|
|
|
4,167 |
|
|
$ |
7,251 |
|
|
|
|
|
|
|
|
|
|
|
|
3,125 |
|
|
|
9,375 |
|
|
|
|
|
|
$ |
1.89 |
|
|
|
1/5/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,250 |
|
|
|
|
|
|
$ |
1.68 |
|
|
|
2/20/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employment Agreements and Potential Payments Upon Termination or Change-in-Control
We believe that reasonable and appropriate severance and change-in-control benefits are
appropriate to protect our named executives against circumstances over which they have no control.
Furthermore, we believe change-in-control severance payments align the named executives interests
with our own by enabling the named executive to evaluate a transaction in the best interests of our
shareholders and our other constituents without undue concern over whether the transaction may
jeopardize the named executives own employment.
We have entered into employment agreements with Messrs. John V. Talley and Robert W. Cook,
each dated as of October 28, 2004. Effective January 4, 2006, pursuant to their employment
agreements, Messrs. Talley and Cook received base salaries of $350,000 and $250,000, respectively.
For 2010, Messrs. Talley and Cook will receive a base salary of $435,000, and $278,512,
respectively. Each employment agreement also provides for discretionary bonuses and stock option
awards and reimbursement of reasonable expenses incurred in connection with services performed
under each officers respective employment agreement. The
discretionary bonuses and stock options are based on performance standards determined by our Board.
Individual performance is determined based on quantitative and qualitative objectives, including
our operating performance relative to budget and the achievement of certain milestones largely
related to the clinical development of our products and licensing activities. The future objectives
will be established by our Board. In addition, Mr. Talleys employment agreement provides for
automobile benefits and term life and long term disability insurance coverage. Both employment
agreements expired on December 31, 2007 but are automatically extended for unlimited additional
one-year periods.
67
The information below describes and quantifies certain compensation that would become payable
under each of Messrs. Talley and Cooks respective employment agreements if, as of December 31,
2009, his employment had been terminated or there was a change in control. Due to the number of
factors that affect the nature and amount of any benefits provided upon the events discussed below,
any actual amounts paid or distributed may be different. Factors that could affect these amounts
include the timing during the year of any such event. We do not have employment agreements with
any other of our named executive officers. If Messrs. Allard, and Bhagwat are terminated without
cause, each is entitled to severance payments of $139,050.
Termination for any Reason. Upon termination for any reason and in addition to any other
payments disbursed in connection with termination, Mr. Talley and Mr. Cook are entitled to:
|
|
|
receive payment of his applicable base salary through the termination date; |
|
|
|
the balance of any annual, long-term or incentive award earned in any period prior to
the termination date; and |
|
|
|
a lump-sum payment for any accrued but unused vacation days. |
Termination due to Death or Disability. If termination occurs due to death or disability, Mr.
Talley is or his estate is entitled to:
|
|
|
a lump-sum payment equal to one-third of his base salary times a fraction, the numerator
being the number of days he was employed in the calendar year of termination and the
denominator being the number of days in that year; |
|
|
|
have 50% of outstanding stock options that are not then vested or exercisable become
vested and exercisable as of the termination date; |
|
|
|
have the remaining outstanding stock options that are not then vested or exercisable
become vested and exercisable ratably and quarterly for two years following the termination
date; and |
|
|
|
have each outstanding stock option remain exercisable for all securities for the later
of (i) the 90th day following the date that the option becomes fully vested and exercisable
and (ii) the first anniversary of the termination date. |
If termination occurs due to death or disability, Mr. Cook or his estate is entitled to
receive the same benefits as Mr. Talley, except the equation for his lump-sum payment is based on
one-fourth of his base salary.
Termination Without Cause. If Mr. Talley is terminated without cause or the term of his
agreement is not extended pursuant to the employment agreement, he is entitled to receive payments
equal to:
|
|
|
the payments he would receive if he were terminated due to death or disability; and |
|
|
|
a lump-sum payment equal to one and one-third times his base salary times the number of
whole and partial months remaining in the term of the agreement (but no more than 12 and no
less than 6) divided by 12. |
If Mr. Cook is terminated without cause or the term of his agreement is not extended pursuant
to the employment agreement, he is entitled to the same benefits as Mr. Talley, but the equation
for his lump-sum payment is based on one and one-fourth times his base salary.
Change-in-Control Arrangements. If Mr. Talley is terminated in anticipation of, or within one
year following, a change of control, he is entitled to:
|
|
|
a lump-sum payment equal to one and one third times his base salary times the number of
whole and partial months remaining in the term of the agreement (but not less than 24)
divided by 12; |
|
|
|
have 50% of outstanding stock options that are not then vested or exercisable become
vested and exercisable as of the termination date; |
|
|
|
the remaining outstanding stock options that are not then vested or exercisable become
vested and exercisable ratably and monthly for the first year following the termination
date; and |
|
|
|
have each outstanding stock option remain exercisable for all securities for the later
of (i) the 90th day following the date that the option becomes fully vested and exercisable
and (ii) the first anniversary of the termination date. |
68
If Mr. Cook is terminated in anticipation of, or within one year following, a change of
control, he is entitled to the same benefits as Mr. Talley, except his lump sum is equal to one and
one-fourth times his base salary times the number of whole and partial months remaining in the term
of the agreement (but no more than 18 and no less than 12) divided by 12.
The following table summarizes the potential payments to our named executive officers with
whom we have entered into employment agreements, assuming that such events occurred as of December
31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accelerated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested |
|
|
Vesting of |
|
|
|
|
|
|
Severance |
|
|
|
|
|
|
Benefit |
|
|
Incentive |
|
|
Incentive |
|
|
|
|
|
|
Amounts |
|
|
Benefits |
|
|
Continuation |
|
|
Units |
|
|
Units |
|
|
Total |
|
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
|
($) |
|
John V. Talley |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Termination for any reason (other than without cause or for good reason) |
|
$ |
54,375 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
54,375 |
|
Termination without cause or for good reason |
|
$ |
435,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
435,000 |
|
Change in control |
|
|
1,160,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,160,000 |
|
Robert W. Cook |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Termination for any reason (other than without cause or for good reason) |
|
$ |
34,814 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
34,814 |
|
Termination without cause or for good reason |
|
$ |
243,698 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
243,698 |
|
Change in control |
|
$ |
348,140 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
348,140 |
|
Stock Option Plans
2005 Equity Incentive Plan
The 2005 Equity Incentive Plan, as amended, was adopted on September 1, 2005 and approved by
stockholders on September 5, 2005, and subsequently amended and approved by stockholders on May 23,
2007 and June 2, 2009. The 2005 Equity Incentive Plan provides for the grant of incentive stock options, within the
meaning of Section 422 of the Internal Revenue Code, to our employees and our parent and subsidiary
corporations employees, and for the grant of nonstatutory stock options, restricted stock,
restricted stock units, performance-based awards and cash awards to our employees, directors and
consultants and our parent and subsidiary corporations employees and consultants.
A total of 13,000,000 shares of our common stock are reserved for issuance pursuant to the
2005 Equity Incentive Plan. As of December 31, 2009, 2.4 million shares are outstanding. No
optionee may be granted an option to purchase more than 1,500,000 shares in any fiscal year.
Our board of directors or a committee of its board administers the 2005 Equity Incentive Plan.
In the case of options intended to qualify as performance-based compensation within the meaning
of Section 162(m) of the Internal Revenue Code, the committee will consist of two or more outside
directors within the meaning of Section 162(m) of the Code. The administrator has the power to
determine the terms of the awards, including the exercise price, the number of shares subject to
each such award, the exercisability of the awards and the form of consideration, if any, payable
upon exercise. The administrator also has the authority to institute an exchange program by which
outstanding awards may be surrendered in exchange for awards with a lower exercise price.
The administrator will determine the exercise price of options granted under the 2005 Equity
Incentive Plan, but with respect to nonstatutory stock options intended to qualify as
performance-based compensation within the meaning of Section 162(m) of the Code and all incentive
stock options, the exercise price must at least be equal to the fair market value of our common
stock on the date of grant. The term of an incentive stock option may not exceed ten years, except
that with respect to any participant who owns 10% of the voting power of all classes of our
outstanding stock, the term must not exceed five years and the exercise price must equal at least
110% of the fair market value on the grant date. The administrator determines the term of all other
options.
69
Restricted stock may be granted under the 2005 Equity Incentive Plan. Restricted stock awards
are shares of our common stock that vest in accordance with terms and conditions established by the
administrator. The administrator will determine the number of shares of restricted stock granted to
any employee. The administrator may impose whatever conditions to vesting it determines to be
appropriate. For example, the administrator may set restrictions based on the achievement of
specific performance goals. Shares of restricted stock that do not vest are subject to our right of
repurchase or forfeiture.
Performance-based awards may be granted under the 2005 Equity Incentive Plan.
Performance-based awards are awards that will result in a payment to a participant only if
performance goals established by the administrator are achieved or the awards otherwise vest. The
administrator will establish organizational or individual performance goals in its discretion,
which, depending on the extent to which they are met, will determine the number and/or the value of
performance units and performance shares to be paid out to participants. The 2005 Equity Incentive
Plan generally does not allow for the transfer of awards and only the recipient of an award may
exercise an award during his or her lifetime.
The 2005 Equity Incentive Plan provides that if we experience a Change of Control (as defined
in the Plan), the administrator may provide at any time prior to the Change of Control that all
then outstanding stock options and unvested cash awards shall immediately vest and become
exercisable and any restrictions on restricted stock awards shall immediately lapse. In addition,
the administrator may provide that all awards held by participants who are at the time of the
Change of Control in our service or the service of one of our subsidiaries or affiliates shall
remain exercisable for the remainder of their terms notwithstanding any subsequent termination of a
participants service. All awards will be subject to the terms of any agreement effecting the
Change of Control, which agreement may provide, without limitation, that in lieu of continuing the
awards, each outstanding stock option shall terminate within a specified number of days after
notice to the holder, and that such holder shall receive, with respect to each share of common
stock subject to such stock option, an amount equal to the excess of the fair market value of such
shares of common stock immediately prior to the occurrence of such Change of Control over the
exercise price (or base price) per share underlying such stock option with such amount payable in
cash, in one or more kinds of property (including the property, if any, payable in the transaction)
or in a combination thereof, as the administrator, in its discretion, shall determine. A provision
like the one contained in the preceding sentence shall be inapplicable to a stock option granted
within six months before the occurrence of a Change of Control if the holder of such stock option
is subject to the reporting requirements of Section 16(a) of the Exchange Act and no exception from
liability under Section 16(b) of the Exchange Act is otherwise available to such holder.
The 2005 Equity Incentive Plan will automatically terminate ten years from the effective date,
unless it is terminated sooner. In addition, our board of directors has the authority to amend,
suspend or terminate the 2005 Equity Incentive Plan provided such action does not impair the rights
of any participant.
1995 Stock Option Plan
The 1995 Stock Option Plan, as amended, was approved by our board of directors in November
1995, and subsequently amended in April 1997, March 1999, February 2002 and June 2002. A total of
797,080 shares of our common stock were authorized for issuance under the 1995 Stock Option Plan.
As of December 31, 2009 and 2008, 83,981 shares were available for issuance under the 1995 Stock
Option Plan. We do not plan to grant any further options from this plan.
The purpose of the 1995 Stock Option Plan was to provide us and our stockholders the benefits
arising out of capital stock ownership by our employees, officers, directors, consultants and
advisors and any of our subsidiaries, who are expected to contribute to our future growth and
success. The 1995 Stock Option Plan provides for the grant of non-statutory stock options to our
(and our majority-owned subsidiaries) employees, officers, directors, consultants or advisors, and
for the grant of incentive stock options meeting the requirements of Section 422 of the Internal
Revenue Code to our employees and employees of our majority-controlled subsidiaries.
A committee duly appointed by our board of directors administered the 1995 Stock Option Plan.
The committee has the authority to (a) construe the respective option agreements and the terms of
the plan; (b) prescribe, amend and rescind rules and regulations relating to the plan; (c)
determine the terms and provisions of the respective option agreements, which need not be
identical; (d) make all other determinations in the judgment of the committee necessary or
desirable for the administration of the plan. From and after the registration of our common stock
under the Securities Exchange Act of 1934, the selection of a director or an officer who is a
reporting person under Section 16(a) of the Exchange Act as a recipient of an option, the timing
of the option grant, the exercise price of the option and the number of shares subject to the
option shall be determined by (a) the committee of the Board, each of which members shall be an
outside director or (b) by a committee consisting of two or more directors having full authority to
act in the matter, each of whom shall be an outside director.
70
The committee shall determine the exercise price of stock options granted under the 1995 Stock
Option Plan, but with respect to all incentive stock options, the exercise price must be at least
equal to the fair market value of our common stock on the date of the grant or, in the case of
grants of incentive stock options to holders of more than 10% of the total combined voting power of
all classes of our stock (10% owners), at least equal to 110% of the fair market value of our
common stock on the date of the grant.
The committee shall determine the term of stock options granted under the 1995 Stock Option
Plan, but such date shall not be later than 10 years after the date of the grant, except in the
case of incentive stock options granted to 10% owners in which case such date shall not be later
than five years after the date of the grant.
Each option granted under the 1995 Stock Option Plan is exercisable in full or in installments
at such time or times and during such period as is set forth in the option agreement evidencing
such option, but no option granted to a reporting person shall be exercisable during the first
six months after the grant.
No optionee may be granted an option to purchase more than 350,000 shares in any fiscal year.
In addition, no incentive stock option may be exercisable for the first time in any one calendar
year for shares of common stock with an aggregate fair market value (as of the date of the grant)
of more than $100,000.
The 1995 Stock Option Plan generally does not allow for the transfer of options and only the
optionee may exercise an option during his or her lifetime.
An optionee may exercise an option at any time within three months following the termination
of the optionees employment or other relationship with us or within one year if such termination
was due to the death or disability of the optionee, but except in the case of the optionees death,
in no event later than the expiration date of the option. If the termination of the optionees
employment is for cause, the option expires immediately upon termination.
The 1995 Stock Option Plan automatically terminated on November 14, 2005.
2005 Employee Stock Purchase Plan
The 2005 Employee Stock Purchase Plan was adopted on September 1, 2005 and approved by the
stockholders on September 5, 2005. The Employee Stock Purchase Plan became effective at the
effective time of the merger with Maxim and a total of 500,000 shares of our common stock have been
reserved for sale.
Our board of directors or a committee of the board will administer the 2005 Employee Stock
Purchase Plan. Our board of directors or the committee will have full and exclusive authority to
interpret the terms of the 2005 Employee Stock Purchase Plan and determine eligibility.
All of our employees are eligible to participate if they are customarily employed by us or any
participating subsidiary for at least 20 hours per week and more than five months in any calendar
year. However, an employee may not be granted an option to purchase stock if such employee:
|
|
|
immediately after the grant owns stock possessing 5% or more of the total combined
voting power or value of all classes of our capital stock, or |
|
|
|
|
whose rights to purchase stock under all of our employee stock purchase plans accrues at
a rate that exceeds $25,000 worth of stock for each calendar year. |
The 2005 Employee Stock Purchase Plan is intended to qualify under Section 423 of the Internal
Revenue Code and generally provides for six-month offering periods beginning on January 1 and July
1 of each calendar year, commencing on January 1, 2006 or such other date as may be determined by
the committee appointed by us to administer the 2005 Employee Stock Purchase Plan. The plan
commenced on November 16, 2007.
The 2005 Employee Stock Purchase Plan permits participants to purchase common stock through
payroll deductions from their eligible compensation, which includes a participants base salary,
wages, overtime pay, shift premium and recurring commissions, but does not include payments for
incentive compensation or bonuses.
Amounts deducted and accumulated by the participant are used to purchase shares of our common
stock at the end of each six-month purchase period. The price is 85% of the lower of the fair
market value of our common stock at the beginning of an offering period or end of an offering
period. Participants may end their participation at any time during an offering period, and will be
paid their payroll deductions to date. Participation ends automatically upon termination of
employment with us.
71
A participant may not transfer rights granted under the 2005 Employee Stock Purchase Plan
other than by will, the laws of descent and distribution or as otherwise provided under the 2005
Employee Stock Purchase Plan.
Our board of directors has the authority to amend or terminate the 2005 Employee Stock
Purchase Plan, except that, subject to certain exceptions described in the 2005 Employee Stock
Purchase Plan, no such action may adversely affect any outstanding rights to purchase stock under
the 2005 Employee Stock Purchase Plan.
2009 Employee Stock Purchase Plan
The 2009 Employee Stock Purchase Plan was adopted by the board of directors on December 4,
2008. The 2009 Employee Stock Purchase Plan became effective on January 1, 2009 and a total of
1,000,000 shares of our common stock have been reserved for sale, pending stockholder approval.
A committee appointed by the board of directors will administer the 2009 Employee Stock
Purchase Plan, and the committee will have full and exclusive authority to interpret its terms and
determine eligibility.
All of our employees are eligible to participate, however, an employee may not purchase stock
if such employee:
|
|
|
is designated by the committee as being ineligible to participate in the 2009 Employee
Stock Purchase Plan as permitted by Section 423(b)(4)(D) of the Internal Revenue Code; |
|
|
|
|
has not been employed by us or any participating subsidiary for at least two years; |
|
|
|
|
is not customarily employed by us or any participating subsidiary for at least 20 hours
per week and more than five months in any calendar year; |
|
|
|
|
immediately after the grant owns stock possessing 5% or more of the total combined
voting power or value of all classes of our capital stock; or |
|
|
|
|
whose rights to purchase stock under all of our employee stock purchase plans accrues at
a rate that exceeds $25,000 worth of stock for each calendar year. |
The 2009 Employee Stock Purchase Plan is intended to qualify under Section 423 of the Internal
Revenue Code and generally provides for successive six-month offering periods beginning on January
1 and July 1 of each calendar year, commencing on January 1, 2009.
The 2009 Employee Stock Purchase Plan permits participants to purchase common stock through
payroll deductions from their eligible compensation, which includes a participants base salary and
any other compensation components determined by the committee.
Amounts deducted and accumulated by the participant are used to purchase shares of our common
stock at the end of each six-month offering period. The maximum number of shares purchasable by a
participant in any offering period is 100,000 shares. The price is 85% of the lower of the fair
market value of our common stock at the beginning of an offering period or end of an offering
period. Participants may end their participation at any time during an offering period, and will be
paid their payroll deductions to date. Participation ends automatically upon termination of
employment with us.
A participant may not transfer rights granted under the 2009 Employee Stock Purchase Plan
other than by will, the laws of descent and distribution or as otherwise provided under the 2009
Employee Stock Purchase Plan.
Our board of directors has the authority to amend or terminate the 2009 Employee Stock
Purchase Plan, except that, subject to certain exceptions described in the 2009 Employee Stock
Purchase Plan, no such action may adversely diminish any outstanding rights under the 2009 Employee
Stock Purchase Plan at the time of termination.
72
The following table sets forth the participation in our employee stock purchase plans by our
named executive officers and all other employees as a group since inception:
|
|
|
|
|
|
|
Shares Purchased |
|
|
|
As of December 31, 2009 |
|
John V. Talley |
|
|
45,698 |
|
Robert W. Cook |
|
|
23,351 |
|
Stephane Allard |
|
|
44,822 |
|
Dileep Bhagwat |
|
|
13,213 |
|
Michael Chen |
|
|
|
|
Ben Tseng |
|
|
17,300 |
|
All other employees |
|
|
67,730 |
|
|
|
|
|
Total |
|
|
212,114 |
|
|
|
|
|
401(k) Plan
In January 2007, we adopted a new Retirement Savings and Investment Plan, the 401(k) Plan,
whereby the two previously existing plans were terminated. The 401(k) Plan provides for matching
contributions by us in an amount equal to the lesser of 50% of the employees deferral or 3% of the
employees qualifying compensation. The 401(k) Plan is intended to qualify under Section 401(k) of
the Internal Revenue Code, so that contributions to the 401(k) Plan by employees or by us, and the
investment earnings thereon, are not taxable to the employees until withdrawn. If the 401(k) Plan
qualifies under Section 401(k) of the Internal Revenue Code, the contributions will be tax
deductible by us when made. Our employees may elect to reduce their current compensation by up to
the statutorily prescribed annual limit of $16,500 if under 50 years old and $22,000 if over 50
years old in 2009 and to have those funds contributed to the 401(k) Plan.
In 1998, we adopted a Retirement Savings and Investment Plan, the old EpiCept 401(k) Plan,
covering its full-time employees located in the United States. The old EpiCept 401(k) Plan was
intended to qualify under Section 401(k) of the Internal Revenue Code, so that contributions to the
401(k) Plan by employees or by us, were the investment earnings thereon, are not taxable to the
employees until withdrawn. The old EpiCept 401(k) Plan was terminated in January 2007.
Upon the completion of the merger with Maxim on January 4, 2006, we adopted and continued the
existing 401(k) retirement plan, the Maxim 401(k) Plan, under which employees of our San Diego
office who met the eligibility requirements may participate and contribute to the 401(k) Plan. The
Maxim 401(k) Plan was terminated in January 2007.
Director Compensation
We compensate our non-employee directors in cash, stock options and restricted stock units.
We also reimburse our non-employee directors for their expenses incurred in connection with
attending board and committee meetings.
For 2009, the compensation committee retained Radford to analyze the Companys non-executive
director and chairman compensation. The committee determined that cash compensation should be
benchmarked to the 50th percentile and that equity-based compensation should be benchmarked to the
75th percentile for comparable companies in the biotechnology and specialty pharmaceutical
industries. As a result of that analysis, the board approved a 2009 annual equity grant for each
named director and for the chairman of 12,500 shares and 21,875 shares, respectively. Eighty percent of the annual director
equity grant was in the form of stock options vesting monthly over
two years and the remainder was comprised of restricted stock units
cliff vesting after two years.
73
The following table set forth all material Director compensation information during the year
ended December 31, 2009:
Director Compensation Table
|
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|
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|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in pension |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
value and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
nonqualified |
|
|
|
|
|
|
|
|
|
Fees Earned |
|
|
|
|
|
|
|
|
|
|
Non-equity |
|
|
deferred |
|
|
|
|
|
|
|
|
|
or Paid in |
|
|
Stock |
|
|
Option |
|
|
Incentive plan |
|
|
compensation |
|
|
All Other |
|
|
|
|
|
|
Cash (1) |
|
|
Awards ($)(2) |
|
|
Awards ($) (3) |
|
|
compensation ($) |
|
|
earnings ($) |
|
|
Compensation |
|
|
Total |
|
Robert G. Savage |
|
$ |
64,750 |
|
|
$ |
9,568 |
|
|
$ |
30,996 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
105,314 |
|
Guy C. Jackson |
|
|
53,500 |
|
|
|
5,468 |
|
|
|
17,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76,680 |
|
Gerhard Waldheim |
|
|
39,000 |
|
|
|
5,468 |
|
|
|
17,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,180 |
|
A. Collier Smyth |
|
|
27,750 |
|
|
|
5,468 |
|
|
|
32,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,546 |
|
Wayne P. Yetter |
|
|
48,000 |
|
|
|
5,468 |
|
|
|
17,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,180 |
|
|
|
|
(1) |
|
This column reports the amount of cash compensation earned in 2009 for Board and committee
service. |
|
(2) |
|
This column represents the grant date fair values for restricted stock units granted in to
the named directors. The grant date fair values have been determined based on the assumptions
and methodologies set forth in the Companys 2009 Annual Report on Form 10-K (Note 11,
Share-Based Payments). |
|
(3) |
|
This column represents the grant date fair values of the stock options awarded to the named
directors in 2009, The grant date fair values have been determined based on the assumptions
and methodologies set forth in the Companys 2009 Annual Report (Note 11, Share-Based
Payments). |
In 2009, the chair person of the board received an annual retainer of $40,000, while each
other non-employee director received an annual retainer of $25,000. In addition, the chairperson of
the audit committee received an annual retainer of $10,000 and the chairperson of each of the other
committees received an annual retainer of $7,500. Each non-employee director also received $1,500
for their attendance at each board meeting, $750 for their participation in each telephonic board
meeting, $750 for their attendance at each committee meeting and $500 for their participation in a
telephonic committee meeting. We have in the past granted non-employee directors restricted stock
units and options to purchase our common stock pursuant to the terms of our 2005 Equity Incentive
Plan upon joining the board and annually thereafter as determined by the Compensation Committee
after considering market data. In 2009, Dr. Smyth, our only new director, received an initial
grant of 11,667 options vesting monthly over three years. Typically annual equity compensation
vests monthly over two years. The option and restricted stock unit awards to the directors in 2009
represent awards to Messrs. Savage, Jackson, Waldheim, Smyth and Yetter. The value of the options
and restricted stock units granted to non-employee directors set forth in the Director Compensation
Table above reflect grants of options and restricted stock units to compensate for their service
and were issued at the market value of our common stock at the date of grant.
Tax Implications of Executive Compensation
We do not believe that Section 162(m) of the Internal Revenue Code, which limits deductions
for executive compensation paid in excess of $1.0 million, is applicable to us, and accordingly,
our Compensation Committee did not consider its impact in determining compensation levels for our
named executive officers in 2008.
Accounting Implications of Executive Compensation
Effective January 1, 2006, we were required to recognize compensation expense of all
stock-based awards pursuant to the principles set forth in in accordance with ASC 718-10,
Compensation Stock Compensation (ASC 718-10). The Summary Compensation and Director
Compensation Tables used the principles set forth in ASC 718-10 to recognize expense for new awards
granted after January 1, 2006 and for unvested awards as of January 1, 2006. The non-cash stock
compensation expense for stock-based awards that we grant is generally recognized ratably over the
requisite vesting period. We continue to believe that stock options, restricted stock, restricted
stock units and other forms of equity compensation are an essential component of our compensation
strategy, and we intend to continue to offer these awards in the future.
74
Compensation Committee Interlocks and Insider Participation
All members of the Compensation Committee of the Board of Directors during the fiscal year
ended December 31, 2009 were independent directors and none of them were our employees or our
former employees. During the fiscal year ended December 31,
2009, none of our executive officers served on the Compensation Committee (or equivalent), or
the board of directors, of another entity whose executive officers served on the Compensation
Committee of our board of directors.
Compensation Committee Report
The Compensation Committee of the Board has reviewed and discussed with management the
Compensation Discussion and Analysis above, and based on such discussions, the Compensation
Committee recommended to the Board that the Compensation Discussion and Analysis be included in our
annual report on Form 10-K.
Respectfully Submitted by:
MEMBERS OF THE COMPENSATION COMMITTEE
Robert G. Savage
Guy C. Jackson
A. Collier Smyth
75
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The following table provides certain information with respect to all of the Companys equity
compensation plans in effect as of December 31, 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities |
|
|
|
Number of securities to |
|
|
|
|
|
|
remaining available for |
|
|
|
be issued upon |
|
|
Weighted-average |
|
|
issuance under equity |
|
|
|
exercise of |
|
|
exercise price of |
|
|
compensation plans |
|
|
|
outstanding options, |
|
|
outstanding options, |
|
|
(excluding securities |
|
|
|
warrants and rights |
|
|
warrants and rights |
|
|
reflected in column (a)) |
|
Plan Category |
|
(a) |
|
|
(b) |
|
|
(c) |
|
Total equity compensation plans approved by stockholders |
|
|
2,412,780 |
|
|
$ |
8.60 |
|
|
|
11,518,913 |
|
Equity compensation plans not approved by stockholders |
|
|
|
|
|
$ |
|
|
|
|
|
|
The following table sets forth information as of March 5, 2010 regarding the beneficial
ownership of the Companys common stock by:
|
|
|
each stockholder known by EpiCept to own beneficially more than five percent of
EpiCept common stock; |
|
|
|
|
each of the named executive officers; |
|
|
|
|
each of EpiCepts directors; and |
|
|
|
|
all of EpiCepts directors and the named executive officers as a group. |
Except as indicated by footnote, and subject to community property laws where applicable, the
persons named in the table have sole voting and investment power with respect to all shares of
common stock shown as beneficially owned by them. Unless otherwise indicated, the principal address
of each of the stockholders below is in care of EpiCept Corporation, 777 Old Saw Mill River Road,
Tarrytown, NY 10591.
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Percent of Shares |
|
Name and Address of Beneficial Owner |
|
Beneficially Owned |
|
|
Beneficially Owned(1)(2) |
|
5% Stockholders |
|
|
|
|
|
|
|
|
Försäkringsaktiebolaget Avanza Pension |
|
|
3,705,915 |
|
|
|
8.39 |
|
Private Equity Direct Finance(3) |
|
|
2,981,194 |
|
|
|
6.60 |
|
Executive Officers and Directors |
|
|
|
|
|
|
|
|
John V. Talley(4) |
|
|
833,995 |
|
|
|
1.86 |
|
Robert W. Cook(5) |
|
|
175,343 |
|
|
|
* |
|
Ben Tseng(6) |
|
|
21,514 |
|
|
|
* |
|
Dr. Dileep Bhagwat(7) |
|
|
153,773 |
|
|
|
* |
|
Dr. Stephane Allard(8) |
|
|
153,562 |
|
|
|
* |
|
Michael Chen(9) |
|
|
2,994 |
|
|
|
* |
|
Robert G. Savage(10) |
|
|
195,251 |
|
|
|
* |
|
Guy Jackson(11) |
|
|
108,025 |
|
|
|
* |
|
Gerhard Waldheim(12) |
|
|
107,941 |
|
|
|
* |
|
Wayne P. Yetter(13) |
|
|
95,675 |
|
|
|
* |
|
Dr. A. Collier Smyth(14) |
|
|
8,798 |
|
|
|
* |
|
All directors and named executive officers as a group (11 persons)(15) |
|
|
1,856,871 |
|
|
|
3.63 |
|
|
|
|
* |
|
Represents beneficial ownership of less than one percent (1%) of the outstanding shares of
EpiCept common stock. |
|
(1) |
|
Beneficial ownership is determined with the rules of the Securities and Exchange Commission
and generally includes voting or investment power with respect to securities. Shares of common
stock subject to stock options and warrants currently exercisable or exercisable within 60
days are deemed to be outstanding for computing the percentage ownership of the person holding
such options and the percentage ownership of any group of which the holder is a member, but
are not deemed outstanding for computing the percentage of any other person. Except as
indicated by footnote, the persons named in the table have sole voting and investment power
with respect to all shares of common stock shown beneficially owned by them. |
76
|
|
|
(2) |
|
Percentage ownership is based on 44,170,984 shares of common stock outstanding on March 5,
2010. |
|
(3) |
|
Includes 1,593,018 shares of common stock and 643,952 shares exercisable upon the exercise of
warrants that are exercisable within 60 days held by Private Equity Direct Finance, 401,941 of
common stock and 334,304 shares exercisable upon the exercise of warrants that are exercisable
within 60 days held by Mr. Peter Derendinger who is a principal of ALPHA Associates (Cayman),
L.P. and 5,319 shares of common stock and 2,660 shares exercisable upon the exercise of
warrants that are exercisable within 60 days held by Guy Myint-Maung, who is a principal of
ALPHA Associates (Cayman). Mr. Derendinger and Mr. Myint-Maung disclaim beneficial ownership
of the shares held by Private Equity Direct Finance except to the extent they have a pecuniary
interest therein. Private Equity Direct Finance is a Cayman Islands exempted limited company
and a wholly-owned subsidiary of Private Equity Holding Cayman, itself a Cayman Islands
exempted limited company, and a wholly-owned subsidiary of Private Equity Holding Ltd. Private
Equity Holding Ltd. is a Swiss corporation with registered office at Innere Guterstrasse 4,
6300 Zug, Switzerland, and listed on the SWXSwiss Exchange. The discretion for divestments by
Private Equity Direct Finance rests with ALPHA Associates (Cayman), L.P., as investment
manager. The members of the board of directors of the general partner of ALPHA Associates
(Cayman), L.P. are the same persons as the members of the board of directors of Private Equity
Direct Finance: Rick Gorter, Gwendolyn McLaughlin and Andrew Tyson. A meeting of the directors
at which a quorum is present is competent to exercise all or any of the powers and
discretions. The quorum necessary for the transaction of business at a meeting of the
directors may be fixed by the directors and, unless so fixed at any other number, is two. The
address of Private Equity Direct Finance is One Capital Place, P.O. Box 847, George Town,
Grand Cayman, Cayman Islands. |
|
(4) |
|
Includes 102,736 shares of common stock, 947 shares of restricted stock and 730,312 shares
exercisable upon the exercise of options that are exercisable within 60 days. |
|
(5) |
|
Includes 31,696 shares of common stock, 219 shares of restricted stock and 143,428 shares
exercisable upon the exercise of options that are exercisable within 60 days. |
|
(6) |
|
Includes 21,514 shares of common stock. |
|
(7) |
|
Includes 19,050 shares of common stock, 328 shares of restricted stock and 134,395 shares
issuable upon the exercise of options that are exercisable within 60 days. |
|
(8) |
|
Includes 56,880 shares of common stock and 96,682 shares issuable upon the exercise of
options that are exercisable within 60 days. |
|
(9) |
|
Includes 2,994 shares of common stock. |
|
(10) |
|
Includes 26,284 shares of common stock and 168,967 shares issuable upon the exercise of
options that are exercisable within 60 days. |
|
(11) |
|
Includes 3,334 shares of common stock and 104,691 shares issuable upon the exercise of
options that are exercisable within 60 days. |
|
(12) |
|
Includes 25,010 shares of common stock and 82,931 shares issuable upon the exercise of
options that are exercisable within 60 days. |
|
(13) |
|
Includes 1,667 shares of common stock and 94,008 shares issuable upon the exercise of options
that are exercisable within 60 days. |
|
(14) |
|
Includes 8,798 shares issuable upon the exercise of options that are exercisable within 60
days. |
|
(15) |
|
Includes 1,565,706 shares issuable upon the exercise of options that are exercisable within
60 days. |
77
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
Transactions with Related Persons
Private Equity Direct Finance, a stockholder known by us to own beneficially more than five
percent of our common stock, participated in one of our financings during the year ended December
31, 2009:
|
|
|
In February 2009, the Company issued $25.0 million principal aggregate amount of
7.5556% convertible subordinated notes due February 2014 and five and-a-half year
warrants to purchase approximately 4.2 million shares of common stock at an exercise
price of $3.105 per share. Each $1,000 in principal aggregate amount of the notes is
initially convertible into approximately 371 shares of Common Stock, at the option of the
holders or upon specified events, including a change of control, and if the Companys
common stock trades at or greater than $5.10 a share for 20 out of 30 days, beginning
February 9, 2010. Upon any conversion or redemption of the notes, the holders will
receive a make-whole payment in an amount equal to the interest payable through the
scheduled maturity of the converted or redeemed notes, less any interest paid before such
conversion or redemption. Interest is due and payable on the notes semi-annually in
arrears on June 30 and December 31, beginning on June 30, 2009. As of December 31, 2009,
approximately $0.5 million in principal aggregate amount of notes was outstanding. |
Director Independence
Each of our non-executive directors is
independent under the standards set forth by The Nasdaq Stock Market.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
We retained Deloitte & Touche LLP as our independent registered public accounting firm to
audit our consolidated financial statements for the years ended December 31, 2009 and 2008.
To ensure the
independence of the firm selected to audit the Companys annual consolidated
financial statements, the audit committee of the Board of Directors has established a policy
allowing it to review in advance and either approve or disapprove, any audit, audit-related,
internal control-related, tax or non-audit service to be provided to us by Deloitte &
Touche LLP. Annually and generally, in the early part of each fiscal year, the audit committee
will approve the engagement of the independent registered public accounting firm to perform the
annual integrated audit of our consolidated financial statements and the effectiveness of our internal controls over financial reporting, and to review our interim
consolidated financial statements.
Independent Registered Public Accounting Firm Fees
The aggregate fees billed for professional services by Deloitte & Touche LLP in 2009 and 2008
for various services were:
|
|
|
|
|
|
|
|
|
Types of Fees |
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Audit Fees (1) |
|
$ |
598 |
|
|
$ |
413 |
|
Audit Related Fees |
|
|
|
|
|
|
|
|
Tax Fees |
|
|
|
|
|
|
|
|
All Other Fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
598 |
|
|
$ |
413 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Fees for services to perform an audit or review in accordance with generally accepted
auditing standards and services that generally only our independent registered public
accounting firm can reasonably provide, such as the audit of our consolidated financial
statements, the review of the consolidated financial statements included in our quarterly
reports on Form 10-Q, consents relating to the filing of registration statements, issuance of
a comfort letter and for services that are normally provided by independent registered public
accounting firms in connection with statutory and regulatory engagements. In 2009, our
independent registered public accounting firm provided an annual attestation report on the
effectiveness of the Companys internal controls over financial reporting, which was not
required in 2008. |
78
PART IV
|
|
|
ITEM 15. |
|
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES |
(a) (1) and (2) Financial Statements and Financial Statement Schedules
The following consolidated financial statements of EpiCept Corporation and subsidiaries, the notes
thereto and the related report thereon of independent registered public accounting firm are filed
under Item 8 of this report.
|
|
|
|
|
Report of Independent Registered Public Accounting Firm |
|
|
|
|
Consolidated Balance Sheets as of December 31, 2009 and 2008 |
|
|
|
|
Consolidated Statements of Operations for the Years Ended December 31, 2009, 2008 and 2007 |
|
|
|
|
Consolidated Statement of Stockholders Deficit for the Years Ended December 31, 2009, 2008 and 2007 |
|
|
|
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2009, 2008 and 2007 |
|
|
|
|
Notes to Consolidated Financial Statements |
|
|
|
|
Schedules for which provision is made in the applicable accounting regulations of the Securities
and Exchange Commission are omitted because they either are not required under the related
instructions, are inapplicable, or the required information is shown in the consolidated financial
statements or the notes thereto.
(a) (3) See Exhibits Index.
(b) Exhibits. See Item 15 (a) (3) above.
(c) Financial Statement Schedules
None.
79
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
EPICEPT CORPORATION
|
|
|
By: |
/s/ John V. Talley
|
|
|
|
John V. Talley |
|
|
|
President and Chief Executive
Officer March 12, 2010 |
|
|
Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the
following persons in the capacities indicated and on the dates indicated:
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ John V. Talley
John V. Talley
|
|
Director, President and Chief Executive Officer
(Principal Executive Officer)
|
|
March 12, 2010 |
|
|
|
|
|
/s/ Robert W. Cook
Robert W. Cook
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
March 12, 2010 |
|
|
|
|
|
/s/ Robert G. Savage
Robert G. Savage
|
|
Director
|
|
March 12, 2010 |
|
|
|
|
|
/s/ Guy C. Jackson
Guy C. Jackson
|
|
Director
|
|
March 12, 2010 |
|
|
|
|
|
/s/ Gerhard Waldheim
Gerhard Waldheim
|
|
Director
|
|
March 12, 2010 |
|
|
|
|
|
/s/ Wayne P. Yetter
Wayne P. Yetter
|
|
Director
|
|
March 12, 2010 |
|
|
|
|
|
/s/ A. Collier Smyth
A. Collier Smyth
|
|
Director
|
|
March 12, 2010 |
80
INDEX TO FINANCIAL STATEMENTS
|
|
|
EPICEPT CORPORATION AND SUBSIDIARIES CONSOLIDATED FINANCIAL STATEMENTS |
|
|
|
|
|
|
|
F-2 |
|
|
|
|
|
F-3 |
|
|
|
|
|
F-4 |
|
|
|
|
|
F-5 |
|
|
|
|
|
F-6 |
|
|
|
|
|
F-8 |
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of
Epicept Corporation
Tarrytown, NY
We have audited the accompanying consolidated balance sheets of EpiCept Corporation and
subsidiaries (the Company) as of December 31, 2009 and 2008, and the related consolidated
statements of operations, stockholders deficit, and cash flows for each of the three years in the
period ended December 31, 2009. These consolidated financial statements are the responsibility of
the Companys management. Our responsibility is to express an opinion on these consolidated
financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, such consolidated financial statements present fairly, in all material respects,
the financial position of EpiCept Corporation and subsidiaries as of December 31, 2009, and 2008,
and the results of their operations and their cash flows for each of the three years in the period
ended December 31, 2009, in conformity with accounting principles generally accepted in the United
States of America.
The accompanying consolidated financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 2 to the consolidated financial statements,
the Companys recurring losses from operations and stockholders deficit raise substantial doubt
about its ability to continue as a going concern. Managements plans concerning these matters are
also described in Note 2. The consolidated financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the Companys internal control over financial reporting as of December 31,
2009, based on the criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 12,
2010 expressed an unqualified opinion on the Companys internal control over financial reporting.
/s/ Deloitte & Touche LLP
Parsippany, New Jersey
March 12, 2010
F-2
EpiCept Corporation and Subsidiaries
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
ASSETS |
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,142 |
|
|
$ |
790 |
|
Inventory |
|
|
1,315 |
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
414 |
|
|
|
395 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
6,871 |
|
|
|
1,185 |
|
Restricted cash |
|
|
227 |
|
|
|
71 |
|
Property and equipment, net |
|
|
360 |
|
|
|
502 |
|
Deferred financing costs |
|
|
28 |
|
|
|
241 |
|
Identifiable intangible asset, net |
|
|
28 |
|
|
|
246 |
|
Other assets |
|
|
|
|
|
|
26 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
7,514 |
|
|
$ |
2,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT |
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,808 |
|
|
$ |
2,778 |
|
Accrued research contract costs |
|
|
1,174 |
|
|
|
1,074 |
|
Accrued interest |
|
|
3 |
|
|
|
9 |
|
Other accrued liabilities |
|
|
1,069 |
|
|
|
2,134 |
|
Notes and loans payable, current portion |
|
|
985 |
|
|
|
3,275 |
|
Deferred revenue, current portion |
|
|
425 |
|
|
|
450 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
5,464 |
|
|
|
9,720 |
|
|
|
|
|
|
|
|
Notes and loans payable |
|
|
618 |
|
|
|
277 |
|
7.5556% Convertible Subordinated Notes Due 2014 |
|
|
349 |
|
|
|
|
|
Deferred revenue |
|
|
9,197 |
|
|
|
9,540 |
|
Deferred rent and other noncurrent liabilities |
|
|
965 |
|
|
|
464 |
|
|
|
|
|
|
|
|
Total long term liabilities |
|
|
11,129 |
|
|
|
10,281 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
16,593 |
|
|
|
20,001 |
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders Deficit: |
|
|
|
|
|
|
|
|
Common stock, $.0001 par value; authorized
225,000,000 shares and issued 44,051,782
shares at December 31, 2009; authorized
175,000,000 shares and issued 27,485,718
shares at December 31, 2008 |
|
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
203,445 |
|
|
|
165,547 |
|
Warrants |
|
|
24,503 |
|
|
|
14,644 |
|
Accumulated deficit |
|
|
(235,045 |
) |
|
|
(196,231 |
) |
Accumulated other comprehensive loss |
|
|
(1,911 |
) |
|
|
(1,618 |
) |
Treasury stock, at cost (4,167 shares) |
|
|
(75 |
) |
|
|
(75 |
) |
|
|
|
|
|
|
|
Total stockholders deficit |
|
|
(9,079 |
) |
|
|
(17,730 |
) |
|
|
|
|
|
|
|
Total liabilities and stockholders deficit |
|
$ |
7,514 |
|
|
$ |
2,271 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-3
EpiCept Corporation and Subsidiaries
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Revenue |
|
$ |
414 |
|
|
$ |
265 |
|
|
$ |
327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
7,548 |
|
|
|
9,599 |
|
|
|
11,759 |
|
Research and development |
|
|
11,603 |
|
|
|
12,623 |
|
|
|
15,312 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
19,151 |
|
|
|
22,222 |
|
|
|
27,071 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(18,737 |
) |
|
|
(21,957 |
) |
|
|
(26,744 |
) |
|
|
|
|
|
|
|
|
|
|
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
32 |
|
|
|
33 |
|
|
|
113 |
|
Foreign exchange gain (loss) |
|
|
221 |
|
|
|
(327 |
) |
|
|
530 |
|
Interest expense (See note 3) |
|
|
(20,021 |
) |
|
|
(1,266 |
) |
|
|
(2,287 |
) |
Change in value of warrants and derivatives |
|
|
(305 |
) |
|
|
113 |
|
|
|
(794 |
) |
(Loss) gain on extinguishment of debt |
|
|
|
|
|
|
(1,975 |
) |
|
|
493 |
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
|
(20,073 |
) |
|
|
(3,422 |
) |
|
|
(1,945 |
) |
|
|
|
|
|
|
|
|
|
|
Loss before income tax expense |
|
|
(38,810 |
) |
|
|
(25,379 |
) |
|
|
(28,689 |
) |
Income tax expense |
|
|
(4 |
) |
|
|
(3 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(38,814 |
) |
|
$ |
(25,382 |
) |
|
$ |
(28,693 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share |
|
$ |
(0.97 |
) |
|
$ |
(1.23 |
) |
|
$ |
(2.37 |
) |
Weighted average common shares outstanding |
|
|
40,139,299 |
|
|
|
20,685,711 |
|
|
|
12,129,258 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-4
EpiCept Corporation and Subsidiaries
Consolidated
Statements of Stockholders Deficit
(In thousands, except share and per share amounts)
For the Years Ended December 31, 2007, 2008 and 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Paid-In |
|
|
|
|
|
|
Accumulated |
|
|
Comprehensive |
|
|
Treasury |
|
|
Stockholders |
|
|
Comprehensive |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Warrants |
|
|
Deficit |
|
|
(Loss) Income |
|
|
Stock |
|
|
Deficit |
|
|
Loss |
|
Balance at January 1, 2007 |
|
|
10,801,632 |
|
|
$ |
1 |
|
|
$ |
130,107 |
|
|
$ |
4,028 |
|
|
$ |
(142,156 |
) |
|
$ |
(1,278 |
) |
|
$ |
(75 |
) |
|
$ |
(9,373 |
) |
|
$ |
(66,047 |
) |
Reclass warrants from equity to liability |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
795 |
|
|
|
|
|
Reclass warrants from liability to equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(653 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(653 |
) |
|
|
|
|
Payment of deferred financing costs |
|
|
|
|
|
|
|
|
|
|
(46 |
) |
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(64 |
) |
|
|
|
|
Exercise of stock options |
|
|
1,885 |
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
|
|
Exercise of warrants |
|
|
133,334 |
|
|
|
|
|
|
|
584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
584 |
|
|
|
|
|
Issuance of common stock and warrants, net |
|
|
4,240,007 |
|
|
|
1 |
|
|
|
15,154 |
|
|
|
5,511 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,666 |
|
|
|
|
|
Issuance of restricted common stock, net |
|
|
11,598 |
|
|
|
|
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51 |
|
|
|
|
|
Issuance of common stock, net, as payment of warrant liability |
|
|
105,552 |
|
|
|
|
|
|
|
506 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
506 |
|
|
|
|
|
Issuance of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
362 |
|
|
|
|
|
Amortization of deferred stock compensation |
|
|
|
|
|
|
|
|
|
|
2,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,402 |
|
|
|
|
|
Stock-based compensation to third parties |
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(772 |
) |
|
|
|
|
|
|
(772 |
) |
|
|
(772 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(28,693 |
) |
|
|
|
|
|
|
|
|
|
|
(28,693 |
) |
|
|
(28,693 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
15,294,008 |
|
|
|
2 |
|
|
|
148,770 |
|
|
|
10,025 |
|
|
|
(170,849 |
) |
|
|
(2,050 |
) |
|
|
(75 |
) |
|
|
(14,177 |
) |
|
|
(29,465 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants |
|
|
2,097,860 |
|
|
|
|
|
|
|
4,159 |
|
|
|
(1,599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,560 |
|
|
|
|
|
Issuance of common stock and warrants, net |
|
|
8,718,304 |
|
|
|
1 |
|
|
|
8,386 |
|
|
|
4,930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,317 |
|
|
|
|
|
Issuance of common stock under ESPP |
|
|
166,667 |
|
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102 |
|
|
|
|
|
Issuance of common stock as payment of loan |
|
|
1,197,411 |
|
|
|
|
|
|
|
1,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,850 |
|
|
|
|
|
Issuance of restricted common stock, net |
|
|
11,468 |
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
Issuance of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
Amortization of deferred stock compensation |
|
|
|
|
|
|
|
|
|
|
2,230 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,230 |
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
432 |
|
|
|
|
|
|
|
432 |
|
|
|
432 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,382 |
) |
|
|
|
|
|
|
|
|
|
|
(25,382 |
) |
|
|
(25,382 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
27,485,718 |
|
|
|
3 |
|
|
|
165,547 |
|
|
|
14,644 |
|
|
|
(196,231 |
) |
|
|
(1,618 |
) |
|
|
(75 |
) |
|
|
(17,730 |
) |
|
|
(24,950 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclass warrants from liability to equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,288 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,288 |
|
|
|
|
|
Issuance of common stock warrants in connection with 7.5556%
convertible subordinated notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,777 |
|
|
|
|
|
Issuance of common stock and warrants, net |
|
|
4,000,000 |
|
|
|
|
|
|
|
6,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,900 |
|
|
|
|
|
Issuance of restricted common stock and restricted stock units, net |
|
|
22,670 |
|
|
|
|
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
55 |
|
|
|
|
|
Issuance of common stock under ESPP |
|
|
49,065 |
|
|
|
|
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75 |
|
|
|
|
|
Conversion of 7.5556% convertible subordinated notes into Common Stock |
|
|
9,074,065 |
|
|
|
1 |
|
|
|
24,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,500 |
|
|
|
|
|
Exercise of warrants |
|
|
3,361,375 |
|
|
|
|
|
|
|
4,976 |
|
|
|
(1,206 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,770 |
|
|
|
|
|
Exercise of stock options |
|
|
58,889 |
|
|
|
|
|
|
|
53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53 |
|
|
|
|
|
Amortization of deferred stock compensation |
|
|
|
|
|
|
|
|
|
|
1,340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,340 |
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(293 |
) |
|
|
|
|
|
|
(293 |
) |
|
|
(293 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,814 |
) |
|
|
|
|
|
|
|
|
|
|
(38,814 |
) |
|
|
(38,814 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
44,051,782 |
|
|
$ |
4 |
|
|
$ |
203,445 |
|
|
$ |
24,503 |
|
|
$ |
(235,045 |
) |
|
$ |
(1,911 |
) |
|
$ |
(75 |
) |
|
$ |
(9,079 |
) |
|
$ |
(39,107 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-5
EpiCept Corporation and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(38,814 |
) |
|
$ |
(25,382 |
) |
|
$ |
(28,693 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
368 |
|
|
|
237 |
|
|
|
859 |
|
Gain on disposal of assets, net |
|
|
(115 |
) |
|
|
(64 |
) |
|
|
|
|
Foreign exchange (gain) loss |
|
|
(221 |
) |
|
|
327 |
|
|
|
(530 |
) |
Stock-based compensation expense |
|
|
1,395 |
|
|
|
2,281 |
|
|
|
2,457 |
|
Non-cash warrant value |
|
|
|
|
|
|
|
|
|
|
362 |
|
Amortization of deferred financing costs and discount on loans |
|
|
10,508 |
|
|
|
431 |
|
|
|
944 |
|
Change in value of warrants and derivatives |
|
|
305 |
|
|
|
(113 |
) |
|
|
794 |
|
Loss (gain) on extinguishment of debt |
|
|
|
|
|
|
1,725 |
|
|
|
(493 |
) |
Change in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Increase in inventory |
|
|
(1,315 |
) |
|
|
|
|
|
|
|
|
(Increase) decrease in prepaid expenses and other current assets |
|
|
(19 |
) |
|
|
211 |
|
|
|
537 |
|
Decrease in other assets |
|
|
26 |
|
|
|
1 |
|
|
|
|
|
(Decrease) increase in accounts payable |
|
|
(769 |
) |
|
|
1,474 |
|
|
|
(916 |
) |
Increase (decrease) in accrued research contract costs |
|
|
100 |
|
|
|
(103 |
) |
|
|
416 |
|
(Decrease) increase in accrued interest |
|
|
(6 |
) |
|
|
(69 |
) |
|
|
76 |
|
(Decrease) increase in other accrued liabilities |
|
|
(1,029 |
) |
|
|
422 |
|
|
|
(41 |
) |
Merger restructuring and litigation payments |
|
|
|
|
|
|
|
|
|
|
(500 |
) |
Increase in deferred revenue |
|
|
|
|
|
|
3,375 |
|
|
|
|
|
Recognition of deferred revenue |
|
|
(368 |
) |
|
|
(222 |
) |
|
|
(284 |
) |
Payment of warrant liability |
|
|
|
|
|
|
|
|
|
|
(663 |
) |
Increase (decrease)) in other liabilities |
|
|
501 |
|
|
|
(168 |
) |
|
|
(150 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(29,453 |
) |
|
|
(15,637 |
) |
|
|
(25,825 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash from issuance of 7.5556% convertible subordinated notes |
|
|
(9,444 |
) |
|
|
|
|
|
|
|
|
Release of restricted cash in connection with conversion of 7.5556%
convertible subordinated notes |
|
|
9,288 |
|
|
|
|
|
|
|
|
|
Change in restricted cash |
|
|
|
|
|
|
265 |
|
|
|
|
|
Purchase of property and equipment |
|
|
(27 |
) |
|
|
(37 |
) |
|
|
(188 |
) |
Proceeds from sale of property and equipment |
|
|
131 |
|
|
|
64 |
|
|
|
23 |
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(52 |
) |
|
|
292 |
|
|
|
(165 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and warrants |
|
|
3,899 |
|
|
|
2,661 |
|
|
|
592 |
|
Proceeds from issuance of common stock and warrants, net |
|
|
8,759 |
|
|
|
13,277 |
|
|
|
20,765 |
|
Proceeds from loans and warrants |
|
|
25,000 |
|
|
|
1,000 |
|
|
|
|
|
Repayment of loans |
|
|
(2,096 |
) |
|
|
(5,794 |
) |
|
|
(3,741 |
) |
Deferred financing costs |
|
|
|
|
|
|
|
|
|
|
(777 |
) |
Debt issuance costs |
|
|
(1,688 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
33,874 |
|
|
|
11,144 |
|
|
|
16,839 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(17 |
) |
|
|
48 |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
4,352 |
|
|
|
(4,153 |
) |
|
|
(9,154 |
) |
Cash and cash equivalents at beginning of year |
|
|
790 |
|
|
|
4,943 |
|
|
|
14,097 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
5,142 |
|
|
$ |
790 |
|
|
$ |
4,943 |
|
|
|
|
|
|
|
|
|
|
|
F-6
EpiCept Corporation and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
9,477 |
|
|
$ |
872 |
|
|
$ |
1,280 |
|
Cash paid for income taxes |
|
|
4 |
|
|
|
3 |
|
|
|
4 |
|
Supplemental disclosure of non-cash financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of 7.5556% convertible subordinated notes into common stock |
|
|
24,500 |
|
|
|
|
|
|
|
|
|
Conversion of senior secured term loan into common stock |
|
|
|
|
|
|
1,850 |
|
|
|
|
|
Reclassification of warrants from equity to liability |
|
|
|
|
|
|
418 |
|
|
|
795 |
|
Reclassification of warrants from liability to equity |
|
|
2,288 |
|
|
|
(305 |
) |
|
|
(653 |
) |
Issuance of common stock in connection with a release and settlement agreement |
|
|
|
|
|
|
|
|
|
|
506 |
|
Unpaid costs associated with issuance of common stock |
|
|
|
|
|
|
124 |
|
|
|
163 |
|
Unpaid financing, initial public offering costs and acquisition costs |
|
|
|
|
|
|
263 |
|
|
|
150 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-7
EPICEPT CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Years Ended December 31, 2008, 2007 and 2006
1. Reverse Split of Common Stock
On January 14, 2010, EpiCept Corporation (EpiCept or the Company) effected a previously
authorized 1-for-3 reverse stock split of its common stock. The reverse stock split took effect at
the start of trading on January 15, 2010 on a 1-for-3 split-adjusted basis. All prior periods have
been retroactively adjusted to reflect the reverse stock split.
2. Organization and Description of Business
EpiCept is a specialty pharmaceutical company focused on the development and commercialization
of pharmaceutical products for the treatment of cancer and pain. The Companys strategy is to focus
its development efforts on innovative cancer therapies and topically delivered analgesics targeting
peripheral nerve receptors. The Companys lead product is Ceplene®, which when used
concomitantly with low dose interleukin-2 is intended as remission maintenance therapy in the
treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete
remission. On October 8, 2008, the European Commission issued a formal marketing authorization for
Ceplene® in the European Union. In November 2009, Health Canada screened and accepted
for review a New Drug Submission (NDS) for Ceplene® for the treatment of AML in Canada
and the Company continues its preparation of a New Drug Application (NDA) filing with the United
States Food and Drug Administration (FDA). In addition to Ceplene®, the Company has
two oncology compounds and a pain product candidate for the treatment of peripheral neuropathies in
clinical development. The Company believes this portfolio of oncology and pain management product
candidates lessens its reliance on the success of any single product or product candidate.
The Companys cancer portfolio includes crinobulin, a novel small molecule vascular disruption
agent (VDA), and apoptosis inducer for the treatment of patients with solid tumors and lymphomas.
The Company has completed its first Phase I clinical trial for crinobulin. AzixaTM, an
apoptosis inducer with VDA activity licensed by the Company to Myriad Genetics, Inc., or Myriad, as
part of an exclusive, worldwide development and commercialization agreement, is currently in Phase
II clinical trials in patients with primary glioblastoma and cancer that has metastasized to the
brain.
The Companys late-stage pain product candidate, EpiCeptTM NP-1 Cream, (NP-1), is
a prescription topical analgesic cream designed to provide effective long-term relief of pain
associated with peripheral neuropathies. In January 2009, the Company concluded a Phase II clinical
trial of NP-1 in which the Company studied its safety and efficacy in patients suffering from
post-herpetic neuralgia, or PHN, compared to gabapentin and placebo. This trial met is primary
endpoints. In February 2008, the Company concluded a Phase II clinical study of NP-1 in patients
suffering from diabetic peripheral neuropathy, or DPN. Both studies support the advancement of
NP-1 into a registration-sized trial. NP-1 utilizes a proprietary formulation to administer FDA
approved pain management therapeutics, or analgesics, directly on the skins surface at or near the
site of the pain, targeting pain that is influenced, or mediated, by nerve receptors located just
beneath the skins surface. Peripheral neuropathy affects over 15 million people in the United
States of America.
Ceplene® has been granted full marketing authorization by the European Commission
for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia
in first remission. None of the Companys other drug candidates has received FDA or foreign
regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory
agencies must conclude that the Companys clinical data and that of its collaborators establish the
safety and efficacy of its drug candidates. Furthermore, the Companys strategy includes entering
into collaborative arrangements with third parties to participate in the clinical development and
commercialization of its products. The Company cannot forecast with any degree of certainty which
of its drug candidates will be subject to future collaborations or how such arrangements would
affect the Companys development plan or capital requirements.
The Company is subject to a number of risks associated with companies in the specialty
pharmaceutical industry. Principal among these are risks associated with the Companys ability to
obtain regulatory approval for its product candidates, its ability to adequately fund its
operations, dependence on collaborative arrangements, the development by the Company or its
competitors of new technological innovations, the dependence on key personnel, the protection of
proprietary technology, the compliance with the FDA and other governmental regulations. The Company
has yet to generate significant product revenues from any of its product candidates. The Company
has financed its operations primarily through the proceeds from the sales of common stock,
warrants, debt instruments, cash proceeds from collaborative relationships and investment income
earned on cash balances and short-term investments.
F-8
The Company has prepared its consolidated financial statements under the assumption that it is
a going concern. The Company has devoted substantially all of its cash resources to research and
development programs and general and administrative expenses, and to date it has not generated any
meaningful revenues from the sale of products. Since inception, the Company has incurred
significant net losses each year. As a result, the Company has an accumulated deficit of $235.0
million as of December 31, 2009. The Companys recurring losses from operations and the accumulated
deficit raise substantial doubt about its ability to continue as a going concern. The consolidated
financial statements do not include any adjustments that might result from the outcome of this
uncertainty. The Companys losses have resulted principally from costs incurred in connection with
its development activities and from general and administrative expenses. Even if the Company
succeeds in developing and commercializing one or more of its product candidates, the Company may
never become profitable. The Company expects to continue to incur significant expenses over the
next several years as it:
|
|
|
works with its European marketing partner in preparation for the launch and the sales
of Ceplene®; |
|
|
|
builds its U.S. sales and marketing capabilities in anticipation of North American
marketing approval of Ceplene®; |
|
|
|
continues to conduct clinical trials for its product candidates; |
|
|
|
seeks regulatory approvals for its product candidates; |
|
|
|
develops, formulates, and commercializes its product candidates; |
|
|
|
implements additional internal systems and develops new infrastructure; |
|
|
|
acquires or in-licenses additional products or technologies or expand the use of its
technologies; |
|
|
|
maintains, defends and expands the scope of its intellectual property; and |
|
|
|
hires additional personnel. |
Cash at December 31, 2009 plus $3 million cash received from Meda AB in connection with the
signing of the Ceplene® European marketing and distribution agreement will be sufficient
to fund the Companys operations and meet debt service into the third quarter 2010. To conserve
cash, the Company may delay or cancel some of its planned development activities that are not
related to Ceplene® during 2010.
3. Significant Accounting Policies
Consolidation
The accompanying consolidated financial statements include the accounts of EpiCept Corporation
and the Companys 100%-owned subsidiaries. All inter-company transactions and balances have been
eliminated.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements. Estimates also affect the reported amounts of
revenues and expenses during the reporting period. Actual results could differ from those
estimates.
Revenue Recognition
The Company recognizes revenue relating to its collaboration agreements in accordance with the
Securities and Exchange Commissions Staff Accounting Bulletin No. 104, Revenue Recognition, and
FASB Accounting Standards Codification (ASC) 605-25, Revenue Recognition Multiple Element
Arrangements (ASC 605-25). Revenue under collaborative arrangements may result from license
fees, milestone payments, research and development payments and royalty payments.
The Companys application of these standards requires subjective determinations and requires
management to make judgments about value of the individual elements and whether they are separable
from the other aspects of the contractual relationship. The Company evaluates its collaboration
agreements to determine units of accounting for revenue recognition purposes. To date, the Company
has determined that its upfront non-refundable license fees cannot be separated from its ongoing
collaborative research and development activities and, accordingly, does not treat them as a
separate element. The Company recognizes revenue from non-refundable, upfront licenses and related
payments, not specifically tied to a separate earnings process, either on the proportional
performance method or ratably over either the development period in which the Company is
F-9
obligated
to participate on a continuing and substantial basis in the research and development activities outlined in the contract, or
the later of 1) the conclusion of the royalty term on a jurisdiction by jurisdiction basis or 2)
the expiration of the last EpiCept licensed patent. Ratable revenue recognition is only utilized if
the research and development services are performed systematically over the development period.
Proportional performance is measured based on costs incurred compared to total estimated costs to
be incurred over the development period which approximates the proportion of the value of the
services provided compared to the total estimated value over the development period. The Company
periodically reviews its estimates of cost and the length of the development period and, to the
extent such estimates change, the impact of the change is recorded at that time.
EpiCept recognizes milestone payments as revenue upon achievement of the milestone only if (1)
it represents a separate unit of accounting as defined in ASC 605-25; (2) the milestone payments
are nonrefundable; (3) substantive effort is involved in achieving the milestone; and (4) the
amount of the milestone is reasonable in relation to the effort expended or the risk associated
with the achievement of the milestone. If any of these conditions is not met, EpiCept will
recognize milestones as revenue in accordance with its accounting policy in effect for the
respective contract. For current agreements, EpiCept recognizes revenue for milestone payments
based upon the portion of the development services that are completed to date and defers the
remaining portion and recognizes it over the remainder of the development services on the
proportional or ratable method, whichever is applicable. Deferred revenue represents the excess of
cash received compared to revenue recognized to date under licensing agreements.
Foreign Currency
The financial statements of the Companys foreign subsidiary are translated into U.S. dollars
using the period-end exchange rate for all balance sheet accounts and the average exchange rates
for income statement accounts. Adjustments resulting from translation have been reported in other
comprehensive loss.
Gains or losses from foreign currency transactions relating to inter-company debt are recorded
in the consolidated statements of operations in other income (expense).
Stock-Based Compensation
The Company has various stock-based compensation plans for employees and outside directors,
which are described more fully in Note 11 Stock Options and Warrants.
Income Taxes
The Company accounts for income taxes in accordance with ASC 740, Income Taxes. The Company
files income tax returns in the U.S. federal jurisdiction and various state and foreign
jurisdictions. The Companys income tax returns for tax years after 2005 are still subject to
review. The Company does not believe there will be any material changes in its unrecognized tax
positions over the next 12 months.
The Companys policy is to recognize interest and penalties accrued on any unrecognized tax
benefits as a component of operating expense. The Company did not have any accrued interest or
penalties associated with any unrecognized tax benefits, nor was any interest expense recognized
during the years ended December 31, 2009, 2008 and 2007. Income tax expense for the years ended
December 31, 2009, 2008 and 2007 is primarily due to minimum state and local income taxes.
The Company accounts for its income taxes under the asset and liability method. Under the
asset and liability method, deferred tax assets and liabilities are recognized based upon the
differences arising from carrying amounts of the Companys assets and liabilities for tax and
financial reporting purposes using enacted tax rates in effect for the year in which the
differences are expected to reverse. The effect on the deferred tax assets and liabilities of a
change in tax rates is recognized in the period when the change in tax rates is enacted. A
valuation allowance is established when it is determined that it is more likely than not that some
portion or all of the deferred tax assets will not be realized. As of December 31, 2009 and 2008, a
full valuation allowance has been applied against the Companys net deferred tax assets because it
is not more likely than not that the Company will realize future benefits associated with these
deferred tax assets (See Note 12).
F-10
Loss Per Share
Basic and diluted loss per share is computed by dividing loss attributable to common
stockholders by the weighted average number of shares of common stock outstanding during the
period. Diluted weighted average shares outstanding excludes shares underlying unvested restricted
stock, restricted stock units, stock options and warrants, since the effects would be
anti-dilutive. Accordingly, basic and diluted loss per share is the same. Such excluded shares are
summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Common stock options |
|
|
2,412,780 |
|
|
|
1,986,689 |
|
|
|
1,289,907 |
|
Restricted stock (unvested) |
|
|
9,956 |
|
|
|
22,936 |
|
|
|
|
|
Restricted stock units (unvested) |
|
|
92,999 |
|
|
|
101,341 |
|
|
|
|
|
Shares issuable upon conversion of convertible debt |
|
|
185,185 |
|
|
|
370,834 |
|
|
|
|
|
Warrants |
|
|
12,989,703 |
|
|
|
11,296,433 |
|
|
|
4,101,433 |
|
|
|
|
|
|
|
|
|
|
|
Total shares excluded from calculation |
|
|
15,690,623 |
|
|
|
13,778,233 |
|
|
|
5,391,340 |
|
|
|
|
|
|
|
|
|
|
|
Interest Expense:
Interest expense consisted of the following for the years ended December 31, 2009, 2008 and
2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
(in $000s) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
$ |
(9,513 |
) |
|
$ |
(835 |
) |
|
$ |
(1,343 |
) |
Amortization of debt issuance costs and discount |
|
|
(10,508 |
) |
|
|
(431 |
) |
|
|
(944 |
) |
|
|
|
|
|
|
|
|
|
|
Total interest expense |
|
$ |
(20,021 |
) |
|
$ |
(1,266 |
) |
|
$ |
(2,287 |
) |
|
|
|
|
|
|
|
|
|
|
Amortization of debt issuance costs and discount and interest expense were both accelerated in
2009 as a result of the conversion of $24.5 million of the Companys 7.5556% convertible
subordinated notes due 2014 into approximately 9.1 million shares of the Companys common stock in
2009. Interest expense for the year ended December 31, 2009 included $10.5 million in amortization
of debt issuance costs and discount and $9.3 million in interest expense paid from escrowed cash
that represented the make-whole interest payment that would have been due at maturity of such
notes.
Cash Equivalents
The Company considers all highly liquid investments with a maturity of 90 days or less when
purchased to be cash equivalents.
Restricted Cash
The Company has lease agreements for the premises it occupies. Letters of credit in lieu of
lease deposits for leased facilities totaling $0.1 million are secured by restricted cash in the
same amount at December 31, 2009 and 2008. During 2008, the Company failed to make certain payments
on its lease agreement for the premises located in San Diego, California. As a result, the landlord
exercised their right to draw down the full letter of credit, amounting to approximately $0.3
million, and applied approximately $0.2 million to unpaid rent. The remaining balance of $0.1
million is classified as prepaid expense.
On February 4, 2009, the Company issued $25.0 million in principal aggregate amount of 7.5556%
convertible subordinated notes due 2014. In connection with the issuance of these notes, the
Company was required to deposit approximately $9.4 million in escrow for up to twenty-four months
for the purposes of paying the interest on the notes and the make-whole payments upon conversion or
redemption. As the result of the conversion of $24.5 million of these notes, approximately $9.3
million was released from restricted cash to fund the make-whole interest payment and $0.2 million
remained in escrow for payment of the interest on the remaining notes not converted and was
accordingly classified as restricted cash at December 31, 2009.
Inventory
Inventories are valued at the lower of cost (first-in, first-out) or market. The Company
periodically evaluates its inventories and will reduce inventory to its net realizable value
depending on certain factors, such as product demand, remaining shelf life, future marketing
plans, obsolescence and slow-moving inventories.
F-11
As of December 31, 2009 and 2008, inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Raw materials |
|
$ |
131 |
|
|
$ |
|
|
Work-in-process |
|
|
1,147 |
|
|
|
|
|
Finished goods |
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
Total inventory |
|
$ |
1,315 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Prepaid Expenses and Other Current Assets
As of December 31, 2009 and 2008, prepaid expenses and other current assets include the
following:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Prepaid expenses |
|
$ |
167 |
|
|
$ |
174 |
|
Prepaid insurance |
|
|
209 |
|
|
|
213 |
|
Other |
|
|
38 |
|
|
|
8 |
|
|
|
|
|
|
|
|
Total prepaid expenses and other current assets |
|
$ |
414 |
|
|
$ |
395 |
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment consists of office furniture and equipment, laboratory equipment, and
leasehold improvements stated at cost. Furniture and equipment are depreciated on a straight-line
basis over their estimated useful lives ranging from five to seven years. Leasehold improvements
are amortized on a straight-line basis over the shorter of the lease term or the estimated useful
life of the asset. Maintenance and repairs are charged to expense as incurred.
Deferred Financing Costs
Deferred financing costs represent legal and other costs and fees incurred to negotiate and
obtain debt financing. Deferred financing costs are capitalized and amortized using the effective
interest method over the life of the applicable financing. During the first quarter of 2009, the
Company incurred approximately $1.6 million in deferred financing costs from the issuance of $25.0
million in principal aggregate amount of 7.5556% convertible subordinated notes due 2014. As a
result of the conversion of $24.5 million of these notes, amortization of the deferred financing
costs was accelerated and amortization expense of $1.6 million was recorded in 2009. As of
December 31, 2009 and 2008, deferred financing costs were approximately $28,000 and $0.2 million,
respectively. Amortization expense was $1.8 million, $0.4 million and $0.5 million for 2009, 2008
and 2007, respectively.
Identifiable Intangible Asset
Identifiable intangible asset consists of the assembled workforce acquired in the merger with
Maxim Pharmaceuticals Inc. (Maxim) in January 2006. The assembled workforce is being amortized on
the greater of the straight-line basis or actual assembled workforce turnover over six years. The
gross carrying amount of the assembled workforce is $0.5 million and approximately $0.5 million of
accumulated amortization has been recorded as of December 31, 2009. Approximately $0.2 million of
amortization was recorded in 2009 due to the layoff of most of the Companys employees at its
facility in San Diego, California in the first half of 2009. Assembled workforce amortization is
recorded in research and development expense. During each of the years 2009, 2008 and 2007, the
Company recorded assembled workforce amortization of $0.2 million, $0.1 million and $0.1 million,
respectively.
Deferred Rent and Other Noncurrent Liabilities
Deferred rent and other noncurrent liabilities represents deferred rent expense on our
facilities in Tarrytown, NY and San Diego, CA. In accordance with accounting principles generally
accepted in the United States of America, the Company recognizes rental expense, including tenant
improvement allowances, on a straight-line basis over the life of the leases or useful life,
whichever is shorter, irrespective of the timing of payments to or from the lessor. During the
second quarter of 2009, the Company ceased use of its discovery research facility in San Diego, CA
as a result of the Companys previously announced decision to discontinue its drug discovery
activities. In accordance with ASC 420-10, Exit or Disposal Cost Activities (ASC 420-10), the
Company recorded a liability of $0.8 million, included in research and development expense on the
consolidated statements of operations, on the cease-use date based on the fair value of the costs
that are expected to be incurred under the lease of the facility. The fair value of the liability
at the cease-use date was determined based on the remaining rental payments, reduced by estimated
sublease rental income that could be
reasonably obtained for the property. As of December 31, 2009 and 2008, the Company had
deferred rent of $1.0 million and $0.4 million, respectively, that is being amortized through
October 2013.
F-12
Impairment of Long-Lived Assets
The Company performs impairment tests on its long-lived assets when circumstances indicate
that their carrying amounts may not be recoverable. If required, recoverability is tested by
comparing the estimated future undiscounted cash flows of the asset or asset group to its carrying
value. If the carrying value is not recoverable, the asset or asset group is written down to fair
value. No such impairments have been identified with respect to the Companys long-lived assets,
which consist primarily of property and equipment at December 31, 2009.
Derivatives
The Company accounts for its derivative instruments in accordance with ASC 815-10,
Derivatives and Hedging (ASC 815-10). ASC 815-10 establishes accounting and reporting
standards requiring that derivative instruments, including derivative instruments embedded in other
contracts, be recorded on the balance sheet as either an asset or liability measured at its fair
value. ASC 815-10 also requires that changes in the fair value of derivative instruments be
recognized currently in results of operations unless specific hedge accounting criteria are met.
The Company has not entered into hedging activities to date. As a result of certain financings (see
Note 7), derivative instruments were created that are measured at fair value and marked to market
at each reporting period. Changes in the derivative value are recorded as change in value of
warrants and derivatives on the consolidated statements of operations.
Other Comprehensive Loss
For 2009, 2008 and 2007, the Companys only element of comprehensive loss other than net loss
was foreign currency translation gain (loss) of ($0.3), $0.4 and $(0.8) million, respectively.
Fair Value of Financial Instruments
The estimated fair values of the Companys financial instruments are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
Carrying |
|
|
Fair |
|
|
Carrying |
|
|
Fair |
|
|
|
Amount |
|
|
Value |
|
|
Amount |
|
|
Value |
|
|
|
(In millions) |
|
Cash and cash equivalents |
|
$ |
5.1 |
|
|
$ |
5.1 |
|
|
$ |
0.8 |
|
|
$ |
0.8 |
|
Non-convertible loans |
|
|
1.6 |
|
|
|
1.7 |
|
|
|
2.5 |
|
|
|
2.7 |
|
Convertible loans |
|
|
0.5 |
|
|
|
0.6 |
|
|
|
1.1 |
|
|
|
1.0 |
|
The following methods and assumptions were used to estimate the fair value of each class of
financial instruments for which it is practicable to estimate that value:
Cash and Cash Equivalents. The estimated fair value of cash and cash equivalents approximates
its carrying value due to the short-term nature of these instruments.
Convertible and Non-Convertible Loans. The estimated fair value of convertible and
non-convertible loans is based on the present value of their cash flows discounted at a rate that
approximates current market returns for issues of similar risk.
Recent Accounting Pronouncements
In February 2010, the Financial Accounting Standards Board (FASB) issued ASU 2010-09,
Subsequent Events (ASC Topic 855) Amendments to Certain Recognition and Disclosure
Requirements. ASU 2010-09 removes the requirement for an SEC filer to disclose a date in both
issued and revised financial statements. The adoption of this pronouncement did not have a
material effect on the Companys consolidated financial statements.
F-13
In October 2009, the FASB approved for issuance Emerging Issues Task Force (EITF) issue 08-01,
Revenue Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting
Standards Codification (ASC) Subtopic 605-25). This
statement provides principles for allocation of consideration among its multiple-elements,
allowing more flexibility in identifying and accounting for separate deliverables under an
arrangement. The EITF introduces an estimated selling price method for valuing the elements of a
bundled arrangement if vendor-specific objective evidence or third-party evidence of selling price
is not available, and significantly expands related disclosure requirements. This standard is
effective on a prospective basis for revenue arrangements entered into or materially modified in
fiscal years beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective
basis, and early application is permitted. The Company is currently evaluating the impact of
adopting this pronouncement.
In June 2009, the FASB issued ASC 105-10, Generally Accepted Accounting Principles (ASC
105-10). ASC 105-10 provides for the FASB Accounting Standards Codification (the Codification)
to become the single official source of authoritative, nongovernmental U.S. generally accepted
accounting principles (GAAP). The Codification did not change GAAP but reorganizes the
literature. ASC 105-10 is effective for interim and annual periods ending after September 15, 2009.
The adoption of this pronouncement did not have a material effect on the Companys consolidated
financial statements.
In May 2009, the FASB issued ASC 855-10, Subsequent Events (ASC 855-10). The objective of
this statement is to establish principles and requirements for subsequent events. In particular,
ASC 855-10 sets forth the period after the balance sheet date during which management of a
reporting entity shall evaluate events or transactions that may occur for potential recognition or
disclosure in the financial statements, the circumstances under which an entity shall recognize
events or transactions occurring after the balance sheet date in its financial statements, and the
disclosures that an entity shall make about events or transactions that occurred after the balance
sheet date. ASC 855-10 is effective for interim or annual financial statements issued after June
15, 2009. The adoption of this pronouncement did not have a material effect on the Companys
consolidated financial statements.
In March 2008, the FASB issued ASC 815-10, Derivatives and Hedging (ASC 815-10). ASC
815-10 requires that an entity provide enhanced disclosures related to derivative and hedging
activities. ASC 815-10 is effective for financial statements issued for fiscal years beginning
after December 15, 2008. The adoption of this pronouncement did not have a material effect on the
Companys consolidated financial statements.
4. License Agreements
Meda AB
In January 2010, the Company entered into an exclusive commercialization agreement for
Ceplene® with Meda AB (Meda), a leading international specialty pharmaceutical company
based in Stockholm, Sweden. Under the terms of the agreement, the Company granted Meda the right
to market Ceplene® in Europe and several other countries including Japan, China, and
Australia. The Company received a $3 million fee on signing and will receive an additional $2
million upon the first commercial launch of Ceplene® in a major European market. The
Company will also receive other milestone payments and a double digit percent royalty on net sales
in the covered territories. Additionally, the Company will be responsible for Ceplenes commercial
supply.
Myriad Genetics, Inc.
In connection with its merger with Maxim on January 4, 2006, EpiCept acquired a license
agreement with Myriad Genetics Inc. (Myriad) under which the Company licensed the MX90745 series
of caspase-inducer anti-cancer compounds, including AzixaTM, to Myriad. Under the terms
of the agreement, Maxim granted to Myriad a research license to develop and commercialize any drug
candidates from the series of compounds during the Research Term (as defined in the agreement) with
a non-exclusive, worldwide, royalty-free license, without the right to sublicense the technology.
Myriad is responsible for the worldwide development and commercialization of any drug candidates
from the series of compounds. Maxim also granted to Myriad a worldwide royalty bearing development
and commercialization license with the right to sublicense the technology. The agreement requires
that Myriad make licensing, research and milestone payments to the Company totaling up to $27
million, of which $3 million was paid and recognized as revenue prior to the merger on January 4,
2006, assuming the successful commercialization of the compound for the treatment of cancer, as
well as pay a royalty on product sales. In March 2008, the Company received a milestone payment
of $1.0 million following dosing of the first patient in a Phase II registration sized clinical
trial, which has been deferred and is being recognized as revenue ratably over the life of the last
to expire patent that expires in July 2024. In 2009, 2008 and 2007, the Company recorded revenue
from Myriad of approximately $0.1 million, $0.1 million and $0, respectively.
F-14
DURECT Corporation
In December 2006, the Company entered into a license agreement with DURECT Corporation
(DURECT), pursuant to which it granted DURECT the exclusive worldwide rights to certain of its
intellectual property for a transdermal patch containing bupivacaine for the treatment of back
pain. Under the terms of the agreement, EpiCept received a $1.0 million payment which has been
deferred and is being recognized as revenue ratably over the life of the last to expire patent that
expires in March 2020. In September 2008, the Company amended its license agreement with DURECT.
Under the terms of the amended agreement, the Company granted DURECT royalty-free, fully paid up,
perpetual and irrevocable rights to the intellectual property licensed as part of the original
agreement in exchange for a cash payment of $2.25 million from DURECT, which has also been deferred
and is being recognized as revenue ratably over the last patent life. In 2009, 2008 and 2007, the
Company recorded revenue from DURECT of approximately $0.3 million, $0.1 million and $0.1 million,
respectively.
Endo Pharmaceuticals Inc.
In December 2003, the Company entered into a license agreement with Endo Pharmaceuticals Inc.
(Endo) under which it granted Endo (and its affiliates) the exclusive (including as to the
Company and its affiliates) worldwide right to commercialize LidoPAIN BP. The Company also granted
Endo worldwide rights to use certain of its patents for the development of certain other
non-sterile, topical lidocaine containing patches, including Lidoderm®, Endos topical
lidocaine-containing patch for the treatment of chronic lower back pain. Upon the execution of the
Endo agreement, the Company received a non-refundable payment of $7.5 million, which has been
deferred and is being recognized as revenue on the proportional performance method. In 2009, 2008
and 2007, the Company recorded revenue from Endo of approximately $24,000, $33,000 and $0.2
million, respectively. The Company is eligible to receive payments of up to $52.5 million upon the
achievement of various milestones relating to product development and regulatory approval for both
the Companys LidoPAIN BP product and licensed Endo products, including Lidoderm®, so
long as, in the case of Endos product candidate, the Companys patents provide protection thereof.
The Company is also entitled to receive royalties from Endo based on the net sales of LidoPAIN BP.
These royalties are payable until generic equivalents to the LidoPAIN BP product are available or
until expiration of the patents covering LidoPAIN BP, whichever is sooner. The Company is also
eligible to receive milestone payments from Endo of up to approximately $30.0 million upon the
achievement of specified net sales milestones for licensed Endo products, including
Lidoderm®, so long as the Companys patents provide protection thereof. The future
amount of milestone payments the Company is eligible to receive under the Endo agreement is $82.5
million.
Under the terms of the license agreement, the Company is responsible for continuing and
completing the development of LidoPAIN BP, including the conduct of all clinical trials and the
supply of the clinical products necessary for those trials and the preparation and submission of
the NDA in order to obtain regulatory approval for LidoPAIN BP. Endo remains responsible for
continuing and completing the development of Lidoderm® for the treatment of chronic
lower back pain, including the conduct of all clinical trials and the supply of the clinical
products necessary for those trials. No progress in the development of LidoPAIN BP or Lidoderm
with respect to back pain has been reported. Accordingly, the Company does not expect to receive
any further cash compensation pursuant to this license agreement.
The Company has the option to negotiate a co-promotion arrangement with Endo for LidoPAIN BP
or similar product in any country in which an NDA (or foreign equivalent) filing has been made
within thirty days of such filing. The Company also has the right to terminate its license to Endo
with respect to any territory in which Endo has failed to commercialize LidoPAIN BP within three
years of the receipt of regulatory approval permitting such commercialization.
Epitome/Dalhousie
In August 1999, the Company entered into a sublicense agreement with Epitome Pharmaceuticals
Limited under which the Company was granted an exclusive license to certain patents for the topical
use of tricyclic anti-depressants and NMDA antagonists as topical analgesics for neuralgia that
were licensed to Epitome by Dalhousie University. These, and other patents, cover the combination
treatment consisting of amitriptyline and ketamine in EpiCeptTM NP-1. This technology
has been incorporated into EpiCept NP-1. In July 2007, the Company converted the sublicense
agreement previously established with Epitome Pharmaceuticals Limited, related to its product
candidate EpiCeptTM NP-1, into a direct license with Dalhousie University. Under this
revised arrangement, the Company gained more favorable terms, including a lower maintenance fee
obligation and reduced royalty rate on future product sales.
F-15
The Company has been granted worldwide rights to make, use, develop, sell and market products
utilizing the licensed technology in connection with passive dermal applications. The Company is
obligated to make payments to Dalhousie upon achievement of
specified milestones and to pay royalties based on annual net sales derived from the products
incorporating the licensed technology. The Company is obligated to pay Dalhousie an annual
maintenance fee until the license agreement expires or is terminated, or an NDA for NP-1 is filed
with the FDA, or Dalhousie will have the option to terminate the contract. The license agreement
with Dalhousie terminates upon the expiration of the last to expire licensed patent. The
sublicense agreement with Epitome terminated in July 2007. Under the termination agreement with
Epitome, the Company made a $0.3 million cash payment, issued five year warrants at an exercise
price of $5.88 per share to purchase 0.1 million shares of its common stock, valued at $0.4 million
using the Black-Scholes option-pricing model and was required to make a $0.3 million cash payment
in 2008 and 2009 as long as the agreement with Dalhousie remained in effect. During each of the
years 2009, 2008 and 2007, the Company paid Epitome a fee of $0.3 million and the Company has no
further obligations with Epitome. During 2009 and 2008, the Company paid Dalhousie a maintenance
fee of $0.5 million and $0.4 million, respectively. During 2007, the Company paid Dalhousie a
signing fee of $0.3 million, a maintenance fee of $0.4 million and a milestone payment of $0.2
million upon the dosing of the first patient in a Phase III clinical trial for the licensed
product. These payments were all expensed to research and development in their respective years.
Shire BioChem
In March 2004 and as amended in January 2005, Maxim entered into a license agreement
reacquiring the rights to the MX2105 series of apoptosis inducer anti-cancer compounds from Shire
Biochem, Inc (formerly known as BioChem Pharma, Inc.) which had previously announced that oncology
would no longer be a therapeutic focus of the companys research and development efforts. Under the
agreement, all rights and obligations of the parties under the July 2000 agreement were terminated
and Shire BioChem agreed to assign and/or license to the Company rights it owned under or shared
under the prior research program. The agreement did not require any up-front payments, however, the
Company is required to provide Shire Biochem a portion of any sublicensing payments the Company
receives if the Company relicenses the series of compounds or make milestone payments to Shire
BioChem totaling up to $26.0 million, assuming the successful commercialization of the compounds by
the Company for the treatment of a cancer indication, as well as pay a royalty on product sales.
The Company accrued a license fee expense of $0.5 million upon the commencement of a Phase I
clinical trial for Crinobulin in 2006. This amount, and approximately $0.1 million in interest,
remains accrued and unpaid as of December 31, 2009.
Hellstrand
In October 1999, the Company entered into a royalty agreement with Dr. Kristoffer Hellstrand
under which the Company has an exclusive license to certain patents for Ceplene®
configured for the systemic treatment of cancer, infectious diseases, autoimmune diseases and other
medical conditions. A predecessor company previously paid Dr. Hellstrand $1 million and agreed to
pay a royalty of 1% on net sales of Ceplene®. In November 2009 the Company expanded its
collaboration with Dr. Hellstrand by concluding a new agreement in which the Company acquired
rights to develop certain new compounds. As compensation for this agreement and for providing
certain ongoing consulting services, the Company awarded Dr. Hellstrand options to purchase 50,000
shares of its common stock having a fair value of $0.1 million and agreed to pay a monthly
consulting fee. Through December 31, 2009, no royalties have been paid.
5. Property and Equipment
Property and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Furniture, office and laboratory equipment |
|
$ |
980 |
|
|
$ |
1,618 |
|
Leasehold improvements |
|
|
764 |
|
|
|
764 |
|
|
|
|
|
|
|
|
|
|
|
1,744 |
|
|
|
2,382 |
|
Less accumulated depreciation |
|
|
(1,384 |
) |
|
|
(1,880 |
) |
|
|
|
|
|
|
|
|
|
$ |
360 |
|
|
$ |
502 |
|
|
|
|
|
|
|
|
Depreciation expense was approximately $0.2 million, $0.2 million and $0.8 million for the
years ended December 31, 2009, 2008 and 2007, respectively. The Company sold excess equipment
during 2009 resulting in a gain of $0.1 million.
F-16
6. Other Accrued Liabilities
Other accrued liabilities consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31 |
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Accrued professional fees |
|
$ |
96 |
|
|
$ |
228 |
|
Accrued salaries and employee benefits |
|
|
709 |
|
|
|
1,276 |
|
Other accrued liabilities |
|
|
264 |
|
|
|
630 |
|
|
|
|
|
|
|
|
|
|
$ |
1,069 |
|
|
$ |
2,134 |
|
|
|
|
|
|
|
|
7. Notes, Loans and Financing
The Company is a party to several loan agreements in the following amounts, none of which had
covenant requirements at December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
December 31 |
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Ten-year, non-amortizing loan due June 30, 2011(1) |
|
$ |
1,326 |
|
|
$ |
2,144 |
|
7.5556% convertible subordinated notes due February 9, 2014(2)) |
|
|
500 |
|
|
|
|
|
Convertible debenture due April 10, 2009(3) |
|
|
|
|
|
|
1,113 |
|
July 2006 note payable due July 1, 2012(4) |
|
|
277 |
|
|
|
380 |
|
August 2006 senior secured term loan due April 1, 2009(5) |
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
Total notes and loans payable and 7.5556% Convertible Subordinated Notes, before debt discount |
|
|
2,103 |
|
|
|
3,645 |
|
Less: Debt discount |
|
|
151 |
|
|
|
93 |
|
|
|
|
|
|
|
|
Total notes and loans payable and 7.5556% Convertible Subordinated Notes |
|
|
1,952 |
|
|
|
3,552 |
|
Less: Notes and loans payable, current portion |
|
|
985 |
|
|
|
3,275 |
|
|
|
|
|
|
|
|
Notes and loans payable and 7.5556% Convertible Subordinated Notes, long-term |
|
$ |
967 |
|
|
$ |
277 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
In August 1997, EpiCept GmbH, a wholly-owned subsidiary of EpiCept, entered into a ten-year
non-amortizing loan in the amount of 1.5 million with Technologie-Beteiligungs Gesellschaft
mbH der Deutschen Ausgleichsbank (tbg). The loan initially bore interest at 6% per annum.
Tbg was also entitled to receive additional compensation equal to 9% of the annual surplus
(income before taxes, as defined in the agreement) of EpiCept GmbH, reduced by any other
compensation received from EpiCept GmbH by virtue of other loans to or investments in EpiCept
GmbH provided that tbg is an equity investor in EpiCept GmbH during that time period. The
Company considered the additional compensation element based on the surplus of EpiCept GmbH to
be a derivative. The Company assigned no value to the derivative at each reporting period as
no surplus of EpiCept GmbH was anticipated over the term of the agreement. In addition, any
additional compensation as a result of surplus would be reduced by the additional interest
noted below. |
|
|
|
At the demand of tbg, additional amounts could have been due at the end of the loan term
up to 30% of the loan amount, plus 6% of the principal balance of the note for each year
after the expiration of the fifth complete year of the loan period, such payments to be
offset by the cumulative amount of all payments made to the lender from the annual surplus
of EpiCept GmbH. The Company was accruing these additional amounts as additional interest
up to the maximum amount due over the term of the loan. |
|
|
|
On December 20, 2007, Epicept GmbH entered into a repayment agreement with tbg, whereby
Epicept GmbH paid tbg approximately 0.2 million ($0.2 million) in January 2008,
representing all interest payable to tbg as of December 31, 2007. The loan balance of 1.5
million ($2.0 million), plus accrued interest at a rate of 7.38% per annum beginning
January 1, 2008 was to be repaid to tbg no later than June 30, 2008. Tbg waived any
additional interest payments of approximately 0.5 million ($0.7 million). Epicept GmbH
considered this a substantial modification to the original debt agreement and has recorded
the new debt at its fair value in accordance with ASC 470-50, Modifications and
Extinguishments (ASC 470-50). As a result of the modification to the original debt
agreement, EpiCept GmbH recorded a gain on the extinguishment of debt of $0.5 million in
December 2007. |
|
|
|
On May 14, 2008, Epicept GmbH entered into a prolongation of the repayment agreement with
tbg, whereby the loan balance of 1.5 million ($2.0 million) was required to be repaid to
tbg no later than December 31, 2008. Interest continued to accrue at a rate of 7.38% per
annum and all the provisions of the repayment agreement dated December 20, 2007 continued
to apply without change. |
F-17
|
|
|
|
|
On November 26, 2008, EpiCept GmbH entered into a second amendment to the repayment
agreement with tbg, whereby the loan balance of 1.5 million ($2.1 million) was required to
be repaid to tbg no later than June 30, 2009. Interest continued to accrue at a rate of
7.38% per annum and all the provisions of the repayment agreement dated December 20, 2007
continued to apply without change. |
|
|
|
On June 25, 2009, EpiCept GmbH entered into a third amendment to the repayment agreement with
tbg, whereby 0.3 million of the loan balance of 1.5 million ($2.1 million) plus accrued
interest of 56,000 ($0.1 million) was repaid to tbg on June 30, 2009. The remaining loan
balance of 1.2 million ($1.7 million) at June 30, 2009 plus accrued interest will be paid in
four semi-annual installments of 0.3 million ($0.4 million) beginning December 31, 2009.
Interest will continue to accrue at a rate of 7.38% per annum and all the provisions of the
repayment agreement dated December 20, 2007 will continue to apply without change. |
|
(2) |
|
On February 4, 2009, the Company issued $25.0 million in principal aggregate amount of
7.5556% convertible subordinated notes due February 2014 and five and-a-half year warrants to
purchase approximately 4.2 million shares of common stock at an exercise price of $3.105 per
share. Each $1,000 in principal aggregate amount of the notes is initially convertible into
approximately 371 shares of Common Stock, at the option of the holders or upon specified
events, including a change of control, and if the Companys common stock trades at or greater
than $5.10 a share for 20 out of 30 days, beginning February 9, 2010. Upon any conversion or
redemption of the notes, the holders will receive a make-whole payment in an amount equal to
the interest payable through the scheduled maturity of the converted or redeemed notes, less
any interest paid before such conversion or redemption. Interest is due and payable on the
notes semi-annually in arrears on June 30 and December 31, beginning on June 30, 2009. |
|
|
|
The Company allocated the $25.0 million in proceeds between the convertible subordinated
notes and the warrants based on their relative fair values. The Company calculated the fair
value of the warrants at the date of the transaction at approximately $8.8 million with a
corresponding amount recorded as a debt discount. The debt discount is being accreted over
the life of the outstanding convertible subordinated notes using the effective interest
method. At the date of the transaction, the fair value of the warrants of $8.8 million was
determined utilizing the Black-Scholes option pricing model under the following
assumptions: dividend yield of 0%, risk free interest rate of 1.99%, volatility of 118% and
an expected life of five years. During 2009, the Company recognized approximately $8.6
million of non-cash interest expense related to the accelerated accretion of the debt
discount as a result of the conversion of $24.5 million of the convertible subordinated
notes into approximately 9.1 million shares of the Companys common stock. |
|
|
|
As of December 31, 2009, after giving effect to the conversions into common stock, the remaining
principal aggregate amount of the notes due 2014 outstanding is $0.5 million. |
|
(3) |
|
In December 2008, the Company completed the sale of subordinated convertible notes due April
10, 2009 for aggregate proceeds of $1.0 million. The notes were convertible into shares of the
Companys common stock at any time upon the election of the
purchasers at $3.00 per share. The
notes were subordinated to the senior secured loan discussed in (4) below. The notes were
issued as an original issue discount obligation in lieu of periodic interest payments and
therefore no interest payments were made under these notes. Accordingly, the aggregate
principal face amount of the notes was $1,112,500. The Company repaid these notes in January
and February 2009. |
|
(4) |
|
In July 2006, the Company entered into a six-year non-interest bearing promissory note in the
amount of $0.8 million with Pharmaceutical Research Associates, Inc., (PRA) as compensation
for PRA assuming liability on a lease of premises in San Diego, CA. The fair value of the note
(assuming an imputed 11.6% interest rate) was $0.6 million and broker fees amounted to $0.2
million at issuance. The note is payable in seventy-two equal installments of $11,000 per
month. The loan balance at December 31, 2009 was $0.3 million. |
|
(5) |
|
In August 2006, the Company entered into a term loan in the amount of $10.0 million with
Hercules Technology Growth Capital, Inc., (Hercules). The interest rate on the loan was
initially 11.7% per year. In addition, the Company issued five year common stock purchase
warrants to Hercules granting them the right to purchase 0.2 million shares of the Companys
common stock at an exercise price of $7.95 per share. As a result of certain anti-dilution
adjustments resulting from a financing consummated by the Company in December 2006 and an
amendment entered into in January 2007, the terms of the warrants issued to Hercules were
adjusted to grant Hercules the right to purchase an aggregate of 0.3 million shares of the
Companys common stock at an exercise price of $4.38 per share. Hercules exercised 0.1 million
warrants in August 2007 and had 0.2 million warrants remaining as of this date. The basic
terms of the loan required monthly payments of interest only through March 1, 2007, with 30
monthly
payments of principal and interest which commenced on April 1, 2007. Any outstanding balance of
the loan and accrued interest was to be repaid on August 30, 2009. In connection with the terms
of the loan agreement, the Company granted Hercules a security interest in substantially all of
the Companys personal property including its intellectual property. |
F-18
|
|
|
|
|
The Company allocated the $10.0 million in proceeds between the term loan and the warrants based
on their relative fair values. The Company calculated the fair value of the warrants at the date
of the transaction at approximately $0.9 million with a corresponding amount recorded as a debt
discount. The debt discount was being accreted over the life of the outstanding term loan using
the effective interest method. At the date of the transaction, the fair value of the warrants of
$0.9 million was determined utilizing the Black-Scholes option pricing model utilizing the
following assumptions: dividend yield of 0%, risk free interest rate of 4.72%, volatility of 69%
and an expected life of five years. During 2009 and 2008, the Company recognized approximately
$0 and $0.1 million, respectively, of non-cash interest expense related to the accretion of the
debt discount. Since inception of the term loan, the Company recognized approximately $0.8
million of non-cash interest expense related to the accretion of the debt discount. |
|
|
|
On May 5, 2008, the Company entered into the first amendment to the loan agreement. Under
this agreement the Company paid an amendment fee of $50,000, agreed to maintain, subject to
certain exceptions, a minimum cash balance of $0.5 million in the Companys bank accounts
that are subject to the security interest maintained by Hercules under the loan agreement
and to deliver an amendment to the warrant agreement. On May 7, 2008, in connection with a
second amendment to the warrant agreement with Hercules, the terms of the warrants issued
to Hercules were adjusted to grant Hercules the right to purchase an aggregate of 0.7
million shares of the Companys common stock at an exercise price of $0.90 per share. As a
result of this amendment, these warrants no longer met the requirements to be accounted for
as equity in accordance with ASC 815-40, Derivatives and Hedging Contracts in Entities
Own Equity (ASC 815-40). Therefore, the warrants were reclassified as a liability from
equity for approximately $0.4 million at the date of the amendment to the loan agreement.
The value of the warrant shares were being marked to market at each reporting period as a
derivative gain or loss. At June 30, 2008, the warrants met the requirements to be
accounted for as equity in accordance with ASC 815-40 and were reclassified as equity from
a liability for $0.3 million. The Company recognized a change in the fair value of
warrants and derivatives of approximately $0.1 million, as a gain on the consolidated
statement of operations. The warrants issued under this amendment were exercised in full
during the third quarter of 2008. |
|
|
|
On June 23, 2008, the Company entered into the second amendment to the loan agreement.
Under this amendment, the Company paid Hercules a $0.3 million restructuring fee and $0.5
million from the restricted cash account toward the last principal installments owed on the
loan. The applicable interest rate on the balance of the loan was increased from 11.7% to
15.0% and the repayment schedule was modified and accelerated. In addition, the Company is
required to make contingent payments of $0.5 million resulting from the approval of
Ceplene®, which was paid in September 2008, and $0.3 million if the Phase II
trial for NP-1 yields statistically significant results of the primary endpoints, which we
paid in February 2009. Hercules was permitted to convert up to $1.9 million of the
outstanding principal balance into up to 1.2 million shares of the Companys common stock
at a price of $1.545 per share. In October 2008 and December 2008, Hercules converted $1.9
million of the outstanding principal balance into approximately 1.2 million shares of the
Companys common stock. The remaining principal balance of this loan was repaid in 2009. |
|
|
|
Finally, in connection with the second amendment to the loan agreement, the Company issued
Hercules warrants to purchase an aggregate of 1.3 million shares of the Companys common
stock at an exercise price of $1.17 per share and an aggregate of 0.3 million shares of the
Companys common stock at an exercise price of $1.23 per share. The Company considered
this a substantial modification to the original debt agreement and recorded the new debt at
its fair value in accordance with ASC 470-50. As a result of the modification to the
original debt agreement, the Company recorded a loss on the extinguishment of debt of $2.0
million in June 2008. |
At December 31, 2009, contractual principal payments due on loans and notes payable are as
follows:
|
|
|
|
|
|
|
As of December 31, |
|
Year Ending |
|
2009 |
|
|
|
(in thousands) |
|
2010 |
|
$ |
985 |
|
2011 |
|
|
555 |
|
2012 |
|
|
63 |
|
2013 |
|
|
|
|
2014 |
|
|
500 |
|
|
|
|
|
Total |
|
$ |
2,103 |
|
|
|
|
|
F-19
8. Preferred Stock
The Company has authorized 5 million undesignated preferred shares. No such preferred stock
was issued and outstanding as of December 31, 2009 and 2008, respectively.
9. Common Stock and Common Stock Warrants
In July 2009, upon receipt of the approval of stockholders, the Company amended its
certificate of incorporation to increase the number of authorized shares of common stock from
175,000,000 to 225,000,000 shares.
On June 23, 2009, the Company raised $9.6 million in gross proceeds, $8.9 million net of $0.7
million in transaction costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Companys common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Companys securities. Approximately
4.0 million shares of the Companys common stock were sold at a price of $2.40 per share. Two and
one-half year common stock purchase warrants were issued to investors granting them the right to
purchase approximately 1.4 million shares of the Companys common stock at an exercise price of
$2.70 per share. The Company allocated the $9.6 million in gross proceeds between the common stock
and the warrants based on their relative fair values. $2.0 million of this amount was allocated to
the warrants. The warrants did not meet the requirements of being accounted for as equity in
accordance with ASC 815-40 since the Company did not have an adequate number of authorized shares
to reserve for the exercise of the warrants. Therefore, the value of the warrant shares were
classified as a liability and were marked to market at June 30, 2009 resulting in a loss of $0.3
million in the statement of operations. On July 2, 2009, the warrants were reclassified from
liability to equity in accordance with ASC 815-40 as a result of stockholders approving an increase
in the number of authorized shares of the Companys common stock.
On August 11, 2008, the Company raised $4.0 million in gross proceeds, $3.7 million net of
$0.3 million in transactions costs, through a public offering of common stock and common stock
purchase warrants registered pursuant to a shelf registration statement on Form S-3 registering the
issuance and sale of up to $50.0 million of the Companys common stock, preferred stock, debt
securities, convertible debt securities and/or warrants to purchase the Companys securities.
Approximately 1.7 million shares of the Companys common stock were sold at a price of $2.2767 per
share. Five year common stock purchase warrants were issued to investors granting them the right
to purchase approximately 0.9 million shares of the Companys common stock at an exercise price of
$1.89 per share and approximately 0.1 million shares of the Companys common stock at an exercise
price of $2.85 per share. In addition, in consideration of the receipt of $1.3 million in
connection with the exercise of all the warrants issued in connection with the Companys public
offering on August 1, 2008 discussed below, the Company agreed to issue to the investors in that offering
new warrants to purchase up to approximately 0.9 million shares of Common Stock of the Company with
an exercise price of $2.079 per share. Such warrants are exercisable until August 11, 2013. The
Company allocated the $3.7 million in gross proceeds between the common stock and the warrants
based on their relative fair values. $1.7 million of this amount was allocated to the warrants.
The warrants meet the requirements of and are being accounted for as equity in accordance with ASC
815-40.
On August 1, 2008, the Company raised $3.0 million in gross proceeds, $2.8 million net of $0.2
million in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Companys common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Companys securities. Approximately
1.8 million shares of the Companys common stock were sold at a price of $1.62 per share. Five
year common stock purchase warrants were issued to investors granting them the right to purchase
approximately 0.9 million shares of the Companys common stock at an exercise price of $1.44 per
share and approximately 0.1 million shares of the Companys common stock at an exercise price of
$2.04 per share. The Company allocated the $3.0 million in gross proceeds between the common stock
and the warrants based on their relative fair values. $0.9 million of this amount was allocated to
the warrants. The warrants meet the requirements of and are being accounted for as equity in
accordance with ASC 815-40.
On July 15, 2008, the Company raised $0.5 million in gross proceeds, $0.5 million net of
$50,000 in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Companys common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Companys securities. Approximately
0.67 million shares of the Companys common
stock were sold at a price of $0.75 per share. Five year common stock purchase warrants were
issued to investors granting them the right to purchase approximately 0.7 million shares of the
Companys common stock at an exercise price of $1.17 per share. The Company allocated the $0.5
million in gross proceeds between the common stock and the warrants based on their relative fair
values. $0.2 million of this amount was allocated to the warrants. The warrants meet the
requirements of and are being accounted for as equity in accordance with ASC 815-40.
F-20
On June 23, 2008, the Company raised $2.0 million in gross proceeds, $1.8 million net of $0.2
million in transactions costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Companys common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Companys securities. Approximately
2.67 million shares of the Companys common stock were sold at a price of $0.75 per share. Five
year common stock purchase warrants were issued to investors granting them the right to purchase
approximately 2.8 million shares of the Companys common stock at an exercise price of $1.17 per
share. The Company allocated the $2.0 million in gross proceeds between the common stock and the
warrants based on their relative fair values. $0.8 million of this amount was allocated to the
warrants. The warrants meet the requirements of and are being accounted for as equity in accordance
with ASC 815-40.
On March 6, 2008, the Company raised $5.0 million in gross proceeds, $4.7 million net of $0.3
million in transaction costs, through a public offering of common stock and common stock purchase
warrants registered pursuant to a shelf registration statement on Form S-3 registering the issuance
and sale of up to $50.0 million of the Companys common stock, preferred stock, debt securities,
convertible debt securities and/or warrants to purchase the Companys securities. Approximately
1.8 million shares of the Companys common stock were sold at a price of $2.7675 per share. Five
year common stock purchase warrants were issued to investors granting them the right to purchase
approximately 1.0 million shares of the Companys common stock at an exercise price of $2.58 per
share. The Company allocated the $5.0 million in gross proceeds between the common stock and the
warrants based on their relative fair values. $1.3 million of this amount was allocated to the
warrants. The warrants meet the requirements of and are being accounted for as equity in accordance
with ASC 815-40.
On August 30, 2006, the Company entered into a senior secured term loan in the amount of $10.0
million with Hercules. Five year common stock purchase warrants were issued to Hercules granting
them the right to purchase 0.2 million shares of the Companys common stock at an exercise price of
$7.95 per share. The fair value of the warrants was determined utilizing the Black-Scholes option
pricing model utilizing the following assumptions: dividend yield of 0%, risk free interest rate of
4.72%, volatility of 69% and an expected life of five years. The value of the warrant shares was
being marked to market each reporting period as a derivative gain or loss. As a result of certain
anti-dilution adjustments resulting from the issuance of common stock consummated on December 21,
2006 and an amendment to the warrants on January 26, 2007, the warrants issued to Hercules were
adjusted to grant Hercules the right to purchase an aggregate of 0.3 million shares of the
Companys common stock at an exercise price of $4.38 per share. As a result of the January 2007
amendment to the warrants, the warrants issued to Hercules met the requirements of and were being
accounted for as equity in accordance with ASC 815-40. The fair value of the warrants as of the
date of the amendment was $0.8 million. Accordingly, the Company reclassified this amount from a
liability to warrants in stockholders deficit at that date. During 2007, the Company recognized
the change in the value of warrants and derivatives of approximately $0.8 million as a loss on the
consolidated statement of operations.
In July 2007, the Company entered into a release and settlement agreement to compensate
Hercules for its inability to sell registered shares following an April 2007 planned exercise of a
portion of the warrants issued by the Company to Hercules. The Company agreed to pay Hercules a
fee of $0.3 million and to compensate Hercules up to $1.1 million on its exercise and sale of a
portion of the warrants, provided such exercise and sale occurred prior to November 1, 2007, to the
extent the market value of the Companys common stock on the date of exercise was less than the
market value of the Companys stock at the time Hercules planned to sell the shares issued pursuant
to the exercise of the warrants. Such compensation, if any, was payable in cash up to $0.6
million, the amount EpiCept received from the mandatory cash exercise of the warrants, with the
remainder payable at the Companys option in cash or in the Companys common stock based on the
fair value of the stock on the date the compensation was paid. The Company considered the
contingent amount a derivative and marked the derivative to market at each reporting date. The 0.1
million warrants relating to the release and settlement agreement were reclassified as a liability
from equity for $0.7 million at the date of the derivative agreement. In August 2007, Hercules
exercised and sold the warrants relating to the release and settlement agreement, resulting in a
total liability to the Company of $1.1 million. The Company paid Hercules $0.6 million in cash
during the third quarter of 2007 and paid the remaining liability of $0.5 million at its option in
its common stock on November 1, 2007.
On May 7, 2008, in connection with a second amendment to the warrant agreement with Hercules,
the terms of the warrants issued to Hercules were adjusted to grant Hercules the right to purchase
an aggregate of 0.7 million shares of the Companys common stock
at an exercise price of $0.90 per share.
F-21
On June 23, 2008, the Company entered into the second amendment to the loan agreement with
Hercules. Under this amendment, the Company issued Hercules warrants to purchase an aggregate of
1.3 million shares of the Companys common stock at an exercise price of $1.17 per share and an
aggregate of 0.3 million shares of the Companys common stock at an exercise price of $1.23 per
share. Hercules had 0.4 million warrants outstanding as of December 31, 2009.
10. Commitments and Contingencies
Leases
The Company leases facilities and certain equipment under agreements through 2013 accounted
for as operating leases. The leases generally contain renewal options and require the Company to
pay all executory costs such as maintenance and insurance. Rent expense approximated $1.3 million,
$1.4 million and $1.3 million for the years ended December 31, 2009, 2008, and 2007, respectively.
Future minimum rental payments under non-cancelable operating leases as of December 31, 2009
are as follows:
|
|
|
|
|
|
|
As of December 31, |
|
Year Ending December 31, |
|
2009 |
|
|
|
(in thousands) |
|
2010 |
|
|
1,064 |
|
2011 |
|
|
1,055 |
|
2012 |
|
|
808 |
|
2013 |
|
|
661 |
|
|
|
|
|
|
|
$ |
3,588 |
|
|
|
|
|
Consulting Contracts and Employment Agreements
The Company is a party to a number of research, consulting, and license agreements, which
require the Company to make payments to the other party to the agreement upon the other party
attaining certain milestones as defined in the agreements. As of December 31, 2009, the Company may
be required to make future milestone payments, totaling approximately $5.5 million, under these
agreements, of which approximately $2.3 million is payable during 2010 and approximately $3.2
million is payable from 2011 through 2015. The Company is obligated to make future royalty payments
to three of its collaborators under existing license agreements, including ones based on net sales
of NP-1 and the other based on net sales of crinobulin, to the extent revenues on such products are
realized. The sublicense agreement with Epitome terminated on July 19, 2007. Under the agreement
with Epitome Pharmaceuticals, a payment of $0.3 million was required to be paid by the Company to
Epitome in each of the years 2009, 2008 and 2007. Under its agreement with Dalhousie University,
the Company is obligated to pay an annual maintenance fee so long as no commercial product sales
have occurred and the Company desires to maintain its rights under the license agreement. During
2007, the Company paid Dalhousie a signing fee of $0.3 million, a maintenance fee of $0.4 million
and a milestone payment of $0.2 million upon the dosing of the first patient in a Phase III
clinical trial for the licensed product. During each of the years 2009 and 2008, the Company paid
Dalhousie a maintenance fee of $0.5 million.
The Companys Board of Directors ratified the employment agreements between the Company and
its chief executive officer and chief financial officer dated as of October 28, 2004. The
employment agreements cover the term through December 31, 2009, and provide for base salary,
discretionary compensation, stock option awards, and reimbursement of reasonable expenses in
connection with services performed under the employment agreements. The agreements also compensate
such officers in the event of their death or disability, termination without cause, or termination
within one year of an initial public offering or a change of control, as defined in the respective
employment agreements. Both employment agreements were automatically renewed for another year,
ending December 31, 2010.
Litigation
There are no material legal proceedings pending against the Company as of December 31, 2009.
F-22
11. Share-Based Payments
The Company records stock-based compensation expense at fair value in accordance with ASC
718-10, Compensation Stock Compensation (ASC 718-10). The Company utilizes the Black-Scholes
valuation method for determination of share-based compensation expense. Certain assumptions need to
be made with respect to utilizing the Black-Scholes valuation model, including the expected life,
volatility, risk-free interest rate and anticipated forfeiture of the stock options. The expected
life of the stock options was calculated using the method allowed by the provisions of ASC 718-10.
In accordance with ASC 718-10, the simplified method for plain vanilla options may be used where
the expected term is equal to the vesting term plus the original contract term divided by two. The
risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a
term approximating the expected life of the options. Estimates of pre-vesting option forfeitures
are based on our experience. The Company will adjust its estimate of forfeitures over the requisite
service period based on the extent to which actual forfeitures differ, or are expected to differ,
from such estimates. Changes in estimated forfeitures will be recognized through a cumulative
catch-up adjustment in the period of change and will also impact the amount of compensation expense
to be recognized in future periods.
The Company accounts for stock-based transactions with non-employees in which services are
received in exchange for the equity instruments based upon the fair value of the equity instruments
issued, in accordance with ASC 718-10 and ASC 505-50, Equity-Based Payments to Non-Employees. The
two factors that most affect charges or credits to operations related to stock-based compensation
are the estimated fair market value of the common stock underlying stock options for which
stock-based compensation is recorded and the estimated volatility of such fair market value. The
value of such options is periodically remeasured and income or expense is recognized during the
vesting terms.
2005 Equity Incentive Plan
The 2005 Equity Incentive Plan (the 2005 Plan) was adopted on September 1, 2005, approved by
stockholders on September 5, 2005 and became effective on January 4, 2006. The 2005 Plan provides
for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue
Code, to EpiCepts employees and its parent and subsidiary corporations employees, and for the
grant of nonstatutory stock options, restricted stock, restricted stock units, performance-based
awards and cash awards to its employees, directors and consultants and its parent and subsidiary
corporations employees and consultants. Options are granted and vest as determined by the Board of
Directors. A total of 13,000,000 shares of EpiCepts common stock are reserved for issuance
pursuant to the 2005 Plan. No optionee may be granted an option to purchase more than 1,500,000
shares in any fiscal year. Options issued pursuant to the 2005 Plan have a maximum maturity of 10
years and generally vest over 4 years from the date of grant. The Company records stock-based
compensation expense at fair value. For the year ended December 31, 2009, the Company issued
approximately 0.7 million options to purchase common stock to certain of its employees and members
of its board of directors and estimated $1.0 million of share-based compensation will be recognized
as compensation expense over the vesting periods. During the year ended December 31, 2009, the
Company also granted 0.3 million stock options that contained a performance condition.
The following table presents the 2009, 2008 and 2007 total employee, board of directors and
third party stock-based compensation expense resulting from the issuance of stock options and the
Employee Stock Purchase Plan included in the consolidated statement of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
General and administrative |
|
$ |
889 |
|
|
$ |
1,792 |
|
|
$ |
2,137 |
|
Research and development |
|
|
506 |
|
|
|
489 |
|
|
|
320 |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation costs before income taxes |
|
|
1,395 |
|
|
|
2,281 |
|
|
|
2,457 |
|
Benefit for income taxes (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net compensation expense |
|
$ |
1,395 |
|
|
$ |
2,281 |
|
|
$ |
2,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The stock-based compensation expense has not been tax-effected due to the recording of a full
valuation allowance against net deferred tax assets. |
F-23
Summarized information for stock option grants for the years ended December 31, 2009 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining Contractual |
|
|
Aggregate Intrinsic |
|
|
|
Options |
|
|
Exercise Price |
|
|
Term (years) |
|
|
Value |
|
Options outstanding at December 31, 2008 |
|
|
1,986,922 |
|
|
$ |
11.94 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
729,167 |
|
|
|
1.89 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(58,889 |
) |
|
|
0.90 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(222,357 |
) |
|
|
13.20 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(22,063 |
) |
|
|
61.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at December 31, 2009 |
|
|
2,412,780 |
|
|
$ |
8.60 |
|
|
|
7.44 |
|
|
$ |
271,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest at December 31, 2009 |
|
|
2,335,871 |
|
|
$ |
8.80 |
|
|
|
6.80 |
|
|
$ |
269,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2009 |
|
|
1,643,638 |
|
|
$ |
11.48 |
|
|
|
6.80 |
|
|
$ |
250,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about stock options outstanding at December 31,
2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
|
|
Options |
|
|
Weighted- |
|
|
Weighted- |
|
|
Shares |
|
|
Weighted- |
|
|
|
Outstanding at |
|
|
Average |
|
|
Average |
|
|
Exercisable at |
|
|
Average |
|
|
|
December 31, |
|
|
Remaining |
|
|
Exercise |
|
|
December 31, |
|
|
Exercise |
|
Range of Exercise Price |
|
2009 |
|
|
Contractual Life |
|
|
Price |
|
|
2009 |
|
|
Price |
|
$0.72 1.89 |
|
|
904,290 |
|
|
8.9 years |
|
|
$ |
1.49 |
|
|
|
412,705 |
|
|
$ |
1.18 |
|
2.19 6.00 |
|
|
715,291 |
|
|
7.4 years |
|
|
$ |
3.75 |
|
|
|
440,109 |
|
|
$ |
3.85 |
|
6.72 10.20 |
|
|
95,006 |
|
|
6.8 years |
|
|
$ |
8.07 |
|
|
|
92,680 |
|
|
$ |
8.07 |
|
17.52 26.04 |
|
|
645,391 |
|
|
6.0 years |
|
|
$ |
17.62 |
|
|
|
645,391 |
|
|
$ |
17.62 |
|
32.07 141.21 |
|
|
52,802 |
|
|
2.7 years |
|
|
$ |
86.55 |
|
|
|
52,802 |
|
|
$ |
86.55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,412,780 |
|
|
|
|
|
|
$ |
8.60 |
|
|
|
1,643,687 |
|
|
$ |
11.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total intrinsic value of options exercised during 2009, 2008 and 2007 was approximately
$0.1 million, $0 and $5,000, respectively. Intrinsic value is measured using the fair market value
at the date of exercise (for shares exercised) or at December 31, 2009 (for outstanding options),
less the applicable exercise price.
The weighted-average fair value of the stock option awards granted to employees was $1.89,
$1.80 and $3.78 for the years ended December 31, 2009, 2008 and 2007, respectively, and was
estimated at the date of grant using the Black-Scholes option-pricing model and the assumptions
noted in the following table:
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
2007 |
Expected life |
|
5 years |
|
5 years |
|
5 years |
Expected volatility |
|
110.0% to 118.0% |
|
87.5% to 118.0% |
|
85.0% to 95.0% |
Risk-free interest rate |
|
1.67% to 2.52% |
|
2.96% to 3.34% |
|
4.66% to 4.79% |
Dividend yield |
|
0% |
|
0% |
|
0% |
The expected life of the stock options was calculated using the method allowed by the
provisions of ASC 718-10. In accordance with ASC 718-10, the simplified method for plain vanilla
options may be used where the expected term is equal to the vesting term plus the original contract
term divided by two. Due to limited Company specific historical volatility data, the Company has
based its estimate of expected volatility of stock awards upon historical volatility rates of
comparable public companies to the extent it was not materially lower than its actual volatility.
For the years 2009, 2008 and 2007, the Companys actual stock volatility rate was higher than the
volatility rates of comparable public companies. Therefore, the Company used its historical
volatility rate for these periods as management believes that this rate will be representative of
future volatility over the expected term of the options. The risk-free interest rate is based on
the rates paid on securities issued by the U.S. Treasury with a term approximating the expected
life of the options. The dividend yield is based on the projected annual dividend payment per
share, divided by the stock price at the date of grant. The Company has never paid cash dividends,
and does not currently intend to pay cash dividends, and thus has assumed a 0% dividend yield.
Pre-vesting forfeitures. Estimates of pre-vesting option forfeitures are based on the
Companys experience. Currently, the Company uses a forfeiture rate of 10%. The Company will adjust
its estimate of forfeitures over the requisite service period based on the extent to which actual
forfeitures differ, or are expected to differ, from such estimates. Changes in estimated
forfeitures will be
recognized through a cumulative catch-up adjustment in the period of change and will also
impact the amount of compensation expense to be recognized in future periods.
F-24
Following the departure of a former director, the Company agreed to extend the period during
which he would be entitled to exercise certain vested stock options to purchase the Companys
common stock from three months following the effective date of his resignation, February 3, 2009,
to six months following such effective date. The Company recorded compensation expense related to
the modification of the exercise period of $3,000 in the first quarter of 2009.
In accordance with the terms of a separation agreement with a former employee, the Company
agreed to extend the period during which he would be entitled to exercise certain vested stock
options to purchase EpiCepts common stock from three months following the effective date of his
resignation, March 19, 2007, to 24 months following such effective date. The Company recorded
compensation expense related to the modification of the exercise period of $50,000 in the first
quarter of 2007.
As of December 31, 2009, the total remaining unrecognized compensation cost related to
non-vested stock options, restricted stock and restricted stock units amounted to $1.1 million,
which will be amortized over the weighted-average remaining requisite service period of 2.02 years.
Restricted Stock
Restricted stock was issued to certain employees in 2007, and entitled the holder to receive a
specified number of shares of the Companys common stock over a four year, monthly vesting term.
This restricted stock grant is accounted for at fair value at the date of grant and an expense is
recognized during the vesting term. Summarized information for restricted stock grants for the year
ended December 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
Restricted Stock |
|
|
Grant Date Value Per Share |
|
Nonvested at December 31, 2008 |
|
|
22,936 |
|
|
$ |
4.38 |
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
(10,586 |
) |
|
|
4.38 |
|
Forfeited |
|
|
(2,394 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2009 |
|
|
9,956 |
|
|
$ |
4.38 |
|
|
|
|
|
|
|
|
|
Restricted Stock Units
Restricted stock units were issued to certain employees and non-employee members of the
Companys Board of Directors in 2009 and 2008, which entitle the holder to receive a specified
number of shares of the Companys common stock at the end of the two year or four year vesting
term. This restricted stock unit grant is accounted for at fair value at the date of grant and an
expense is recognized during the vesting term. Summarized information for restricted stock unit
grants for the year ended December 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock |
|
|
Weighted Average |
|
|
|
Units |
|
|
Grant Date Value Per Share |
|
Nonvested at December 31, 2008 |
|
|
101,341 |
|
|
$ |
3.66 |
|
Granted |
|
|
14,375 |
|
|
|
2.43 |
|
Vested |
|
|
(12,083 |
) |
|
|
6.89 |
|
Forfeited |
|
|
(10,634 |
) |
|
|
4.02 |
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2009 |
|
|
92,999 |
|
|
$ |
3.45 |
|
|
|
|
|
|
|
|
|
1995 Stock Options
Under the terms of the 1995 Stock Option Plan, which terminated on November 14, 2005, 0.1
million options remain vested and outstanding as of December 31, 2009 with a weighted average
exercise price of $3.73.
F-25
2009 Employee Stock Purchase Plan
The 2009 Employee Stock Purchase Plan (the 2009 ESPP) was adopted by the Board of Directors
on December 19, 2008, subject to stockholder approval, and was approved by the stockholders at the
Companys 2009 Annual Meeting held on June 2, 2009. The 2009 ESPP was effective on January 1, 2009
and a total of 1,000,000 shares of common stock have been reserved for sale. The 2009 ESPP is
implemented by offerings of rights to all eligible employees from time to time. Unless otherwise
determined by the Companys Board of Directors, common stock is purchased for accounts of employees
participating in the 2009 ESPP at a price per share equal to the lower of (i) 85% of the fair
market value of a share of the Companys common stock on the first day the offering or (ii) 85% of
the fair market value of a share of the Companys common stock on the last trading day of the
purchase period. The initial period commenced January 1, 2009 and ended on June 30, 2009. Each
subsequent offering period will have a six-month duration.
2005 Employee Stock Purchase Plan
The 2005 Employee Stock Purchase Plan (the 2005 ESPP) was adopted on September 1, 2005 and
approved by the stockholders on September 5, 2005. The Employee Stock Purchase Plan became
effective on January 4, 2006 and a total of 500,000 shares of common stock were reserved for sale.
The Company commenced the administration of the 2005 ESPP in November 2007. The 2005 ESPP is
implemented by offerings of rights to all eligible employees from time to time. Unless otherwise
determined by the Companys Board of Directors, common stock is purchased for accounts of employees
participating in the 2005 ESPP at a price per share equal to the lower of (i) 85% of the fair
market value of a share of the Companys common stock on the first day the offering or (ii) 85% of
the fair market value of a share of the Companys common stock on the last trading day of the
purchase period. The initial period commenced November 16, 2007 and ended June 30, 2008.
The number of shares to be purchased at each balance sheet date is estimated based on the
current amount of employee withholdings and the remaining purchase dates within the offering
period. The fair value of share options expected to vest is estimated using the Black-Scholes
option-pricing model. Share options for employees entering the 2009 ESPP and 2005 ESPP were
estimated using the Black-Scholes option-pricing model and the assumptions noted on the table
below.
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
2007 |
Expected life |
|
.50 years |
|
.50 years |
|
.63 years |
Expected volatility |
|
114.0%-118.0% |
|
97.0% |
|
87.5% |
Risk-free interest rate |
|
0.28%-0.33% |
|
2.13% |
|
3.57% |
Dividend yield |
|
0% |
|
0% |
|
0% |
As of December 31, 2009, 45,447 shares were issued under the 2009 ESPP and 166,667 shares were
issued under the 2005 ESPP. For the years ended December 31, 2009 and 2008, the Company recorded
an expense of $38,000 and $45,000, respectively, based on the estimated number of shares to be
purchased.
F-26
Warrants
The following table summarizes information about warrants outstanding at December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expiration |
|
|
Common Shares |
|
|
Weighted Average |
|
Issued in Connection With |
|
Date |
|
|
Issuable |
|
|
Exercise Price |
|
Acquisition of Maxim January 2006 |
|
|
2011 |
|
|
|
595 |
|
|
$ |
111.93 |
|
February 2006 stock issuance |
|
|
2011 |
|
|
|
340,069 |
|
|
|
12.00 |
|
December 2006 stock issuance |
|
|
2011 |
|
|
|
1,284,933 |
|
|
|
4.41 |
|
June 2007 stock issuance (See Note 9) |
|
|
2012 |
|
|
|
889,576 |
|
|
|
8.79 |
|
Termination of sublicense agreement |
|
|
2012 |
|
|
|
83,333 |
|
|
|
5.88 |
|
October 2007 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
709,745 |
|
|
|
5.64 |
|
December 2007 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
555,555 |
|
|
|
4.50 |
|
March 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
1,011,744 |
|
|
|
2.58 |
|
Senior Secured Term Loan (See Note 7) |
|
|
2013 |
|
|
|
61,301 |
|
|
|
1.17 |
|
Senior Secured Term Loan (See Note 7) |
|
|
2013 |
|
|
|
325,203 |
|
|
|
1.23 |
|
June 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
766,667 |
|
|
|
1.17 |
|
July 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
33,333 |
|
|
|
1.17 |
|
August 1, 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
92,166 |
|
|
|
2.04 |
|
August 11, 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
60,409 |
|
|
|
1.89 |
|
August 11, 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
921,659 |
|
|
|
2.08 |
|
August 11, 2008 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
86,748 |
|
|
|
2.85 |
|
February 2009 convertible debt (See Note 7) |
|
|
2014 |
|
|
|
3,703,704 |
|
|
|
3.11 |
|
February 2009 convertible debt (See Note 7) |
|
|
2013 |
|
|
|
462,963 |
|
|
|
3.87 |
|
June 2009 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
1,400,000 |
|
|
|
2.70 |
|
June 2009 stock issuance (See Note 9) |
|
|
2013 |
|
|
|
200,000 |
|
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
12,989,703 |
|
|
$ |
3.76 |
|
|
|
|
|
|
|
|
|
|
|
|
F-27
12. Income Taxes
Deferred income taxes reflect the net effects of temporary differences between the carrying
amounts of assets and liabilities for financial reporting purposes and the amounts used for income
tax purposes. The Companys deferred tax assets relate primarily to its net operating loss
carryforwards and other balance sheet basis differences. In accordance with ASC 740, Income
Taxes, the Company recorded a valuation allowance to fully offset the net deferred tax asset,
because it is not more likely than not that the Company will realize future benefits associated
with these deferred tax assets at December 31, 2009 and 2008. The change in the valuation allowance
for the years ended December 31, 2009 and 2008 was an increase of approximately $0.4 million and
$11.9 million, respectively. The increase in the valuation allowance of $0.4 million during the
year ended December 31, 2009 was net of a decrease in the valuation allowance of $15.0 million as a
result of a decrease in the gross deferred tax asset related to the net operating loss carryforward
due to an ownership change under Internal Revenue Code Section 382. Significant components of the
Companys deferred tax assets at December 31, 2009 and 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(in thousands) |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Patent costs |
|
$ |
887 |
|
|
$ |
1,044 |
|
Stock-based compensation |
|
|
5,093 |
|
|
|
4,811 |
|
Accrued liabilities U.S. |
|
|
237 |
|
|
|
322 |
|
Accrued liabilities foreign |
|
|
395 |
|
|
|
395 |
|
Deferred revenue |
|
|
3,220 |
|
|
|
3,539 |
|
Fixed assets |
|
|
724 |
|
|
|
707 |
|
Deferred rent |
|
|
322 |
|
|
|
72 |
|
Other |
|
|
(86 |
) |
|
|
(76 |
) |
Warrant |
|
|
554 |
|
|
|
493 |
|
Credits |
|
|
3,501 |
|
|
|
3,249 |
|
Net operating loss carryforwards U.S. |
|
|
36,515 |
|
|
|
36,533 |
|
Net operating loss carryforwards foreign |
|
|
4,514 |
|
|
|
4,421 |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
55,876 |
|
|
|
55,583 |
|
Valuation allowance |
|
|
(55,876 |
) |
|
|
(55,468 |
) |
|
|
|
|
|
|
|
Net deferred tax asset |
|
|
|
|
|
|
115 |
|
FIN 48 liability |
|
|
|
|
|
|
(115 |
) |
|
|
|
|
|
|
|
Net deferred taxes |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
A reconciliation of the federal statutory tax rate and the effective tax rates for the years
ended December 31, 2009, 2008 and 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Year Ended |
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
Statutory tax rate |
|
|
(34.0 |
)% |
|
|
(34.0 |
)% |
|
|
(34.0 |
)% |
State income taxes, net of federal benefit |
|
|
(5.5 |
) |
|
|
(5.5 |
) |
|
|
0.0 |
|
Equity-based compensation |
|
|
0.5 |
|
|
|
0.0 |
|
|
|
0.0 |
|
Other |
|
|
0.0 |
|
|
|
0.2 |
|
|
|
(0.5 |
) |
Change in foreign rates |
|
|
0.0 |
|
|
|
0.0 |
|
|
|
3.6 |
|
Change in valuation allowance |
|
|
39.0 |
|
|
|
39.3 |
|
|
|
30.9 |
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
(0 |
)% |
|
|
(0 |
)% |
|
|
(0 |
)% |
|
|
|
|
|
|
|
|
|
|
The principal differences between the U.S. statutory tax rate of 34% and the Companys
effective tax rates of (0)% for the years ended December 31, 2009, 2008 and 2007 is primarily due
to the Companys valuation allowance and the write-down of net operating loss carryforwards due to
an ownership change under Internal Revenue Code Section 382 in the years 2009 and 2007.
F-28
The Company has approximately $201.3 million of net operating loss carryforwards (federal,
state and foreign) and tax credit carryforwards of $3.5 million as of December 31, 2009. The
Company reduced its tax attributes (NOLs and tax credits) as a result of the Companys ownership
changes in 2009 and 2007 and the limitation placed on the utilization of its tax attributes as a
substantial
portion of the NOLs and tax credits generated prior to the ownership change will likely
expire unused. Accordingly, the federal NOLs were reduced by approximately $290 million and the tax credit
carryforwards were reduced by approximately $7.3 million.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(in millions) |
|
Federal NOLs |
|
$ |
90.8 |
|
|
$ |
87.4 |
|
State NOLs |
|
|
95.5 |
|
|
|
95.6 |
|
Foreign NOLs |
|
|
15.0 |
|
|
|
14.7 |
|
|
|
|
|
|
|
|
Total NOLs |
|
$ |
201.3 |
|
|
$ |
197.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Federal Credits |
|
$ |
301 |
|
|
$ |
55 |
|
State Credits |
|
|
3,199 |
|
|
|
3,194 |
|
|
|
|
|
|
|
|
Total Credits |
|
$ |
3,500 |
|
|
$ |
3,249 |
|
|
|
|
|
|
|
|
The Companys federal NOLs of $90.8 million and state NOLs of $95.5 million begin to
expire after 2012 up through 2029. The Companys foreign NOLs of $15.0 million do not expire. The
Companys federal and state tax credits of $3.5 million begin to expire in 2024 through 2029.
As of January 1, 2007, the Company adopted guidance on accounting for uncertainty in income
taxes which clarified the accounting for income taxes by prescribing the minimum threshold a tax
position is required to meet before being recognized in the financial statements as well as
guidance on de-recognition, measurement, classification and disclosure of tax positions. The
adoption of this guidance by the Company did not have a material impact on the Companys financial
condition or results of operations and resulted in no cumulative effect of accounting change being
recorded as of January 1, 2007. The Company has gross liabilities recorded of zero, $0.1 million
and $0.1 million as of December 31, 2009, 2008 and 2007. A reconciliation of the beginning and
ending amount of gross unrecognized tax benefits is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Balance at January 1, |
|
$ |
115 |
|
|
$ |
115 |
|
|
$ |
|
|
Additions (reductions) related to tax positions |
|
|
(115 |
) |
|
|
|
|
|
|
115 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, |
|
$ |
|
|
|
$ |
115 |
|
|
$ |
115 |
|
|
|
|
|
|
|
|
|
|
|
The Company recognizes interest accrued related to unrecognized tax benefits in interest
expense and penalties in operating expense. The Company had not accrued any interest or penalties
related to unrecognized tax benefits. The unrecognized tax benefit liability as of December 31,
2008 and 2007 offsets net deferred tax assets.
F-29
13. Segment and Geographic Information
The Company operates as one reportable segment. The Company maintains development operations
in the United States and Germany. Geographic information for the years ended December 31, 2009,
2008 and 2007 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
412 |
|
|
$ |
262 |
|
|
$ |
306 |
|
Germany |
|
|
2 |
|
|
|
3 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
414 |
|
|
$ |
265 |
|
|
$ |
327 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
38,505 |
|
|
$ |
24,218 |
|
|
$ |
28,701 |
|
Germany |
|
|
309 |
|
|
|
1,164 |
|
|
|
(8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
38,814 |
|
|
$ |
25,382 |
|
|
$ |
28,693 |
|
|
|
|
|
|
|
|
|
|
|
Total Assets |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
7,417 |
|
|
$ |
2,219 |
|
|
$ |
7,281 |
|
Germany |
|
|
97 |
|
|
|
52 |
|
|
|
117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,514 |
|
|
$ |
2,271 |
|
|
$ |
7,398 |
|
|
|
|
|
|
|
|
|
|
|
Long Lived Assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
348 |
|
|
$ |
499 |
|
|
$ |
595 |
|
Germany |
|
|
12 |
|
|
|
3 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
360 |
|
|
$ |
502 |
|
|
$ |
599 |
|
|
|
|
|
|
|
|
|
|
|
14. Quarterly Results (Unaudited)
Summarized quarterly results of operations for the years ended December 31, 2009 and 2008 are
as follows (in thousands except per share and share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2009 |
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
(in thousands, except for share and per share amounts) |
|
Revenue |
|
$ |
115 |
|
|
$ |
91 |
|
|
$ |
116 |
|
|
$ |
92 |
|
Operating expenses |
|
|
4,197 |
|
|
|
5,541 |
|
|
|
5,136 |
|
|
|
4,278 |
|
Net loss |
|
|
(22,487 |
) |
|
|
(7,079 |
) |
|
|
(4,813 |
) |
|
|
(4,436 |
) |
Basic and diluted loss per common share(1) |
|
|
(0.68 |
) |
|
|
(0.18 |
) |
|
|
(0.11 |
) |
|
|
(0.10 |
) |
Weighted average shares outstanding |
|
|
32,894,822 |
|
|
|
39,727,916 |
|
|
|
43,740,961 |
|
|
|
44,031,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2008 |
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
|
(in thousands, except for share and per share amounts) |
|
Revenue |
|
$ |
49 |
|
|
$ |
42 |
|
|
$ |
78 |
|
|
$ |
96 |
|
Operating expenses |
|
|
6,060 |
|
|
|
5,562 |
|
|
|
5,440 |
|
|
|
5,159 |
|
Net loss |
|
|
(6,077 |
) |
|
|
(7,765 |
) |
|
|
(6,163 |
) |
|
|
(5,375 |
) |
Basic and diluted loss per common share(1) |
|
|
(0.38 |
) |
|
|
(0.45 |
) |
|
|
(0.27 |
) |
|
|
(0.20 |
) |
Weighted average shares outstanding |
|
|
15,807,021 |
|
|
|
17,337,415 |
|
|
|
23,135,616 |
|
|
|
26,384,236 |
|
|
|
|
(1) |
|
Basic and diluted loss per common share are computed independently for each of the periods
presented. Accordingly, the sum of the quarterly loss per common share amounts may not agree
to the total for the year. |
15. Subsequent Events (unaudited)
None.
F-30
Exhibit Index
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibits |
|
2.1 |
|
|
Agreement and Plan of Merger, dated as of September 6, 2005, among EpiCept Corporation,
Magazine Acquisition Corp. and Maxim Pharmaceuticals, Inc. (incorporated by reference to
Exhibit 2.1 to Maxim Pharmaceuticals Inc.s Current Report on Form 8-K filed September 6,
2005). |
|
|
|
|
|
|
3.1 |
|
|
Third Amended and Restated Certificate of Incorporation of EpiCept Corporation (incorporated
by reference to Exhibit 3.1 to EpiCept Corporations Current Report on Form 8-K filed May 21,
2008). |
|
|
|
|
|
|
3.2 |
|
|
Amendment to the Third Amended and Restated Certificate of Incorporation (incorporated by
reference to Exhibit 3.1 to EpiCept Corporations Current Report on Form 8-K filed July 9,
2009). |
|
|
|
|
|
|
3.3 |
|
|
Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation,
filed with the Secretary of State of the State of Delaware on January 14, 2010 (incorporated
by reference to Exhibit 3.1 to EpiCept Corporations Current Report on Form 8-K filed
January 14, 2010). |
|
|
|
|
|
|
3.4 |
|
|
Amended and Restated Bylaws of EpiCept Corporation (incorporated by reference to Exhibit 3.1
to EpiCept Corporations Current Report on Form 8-K filed February 18, 2010). |
|
|
|
|
|
|
4.1 |
|
|
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the EpiCepts
Corporations Registration Statement on Form S-1 (File No. 333-121938) (the EpiCept
Form S-1)). |
|
|
|
|
|
|
4.2 |
|
|
Convertible Debenture due April 10, 2009 (incorporated by reference to Exhibit 4.1 to EpiCept
Corporations Current Report on Form 8-K, filed December 9, 2008). |
|
|
|
|
|
|
4.3 |
|
|
Indenture between EpiCept Corporation and Bank of New York Mellon, as Trustee, dated February
9, 2009 (incorporated by reference to Exhibit 4.1 to Epicept Corporations Current Report on
Form 8-K, filed February 10, 2009). |
|
|
|
|
|
|
10.1 |
|
|
Form of Indemnification Agreement between EpiCept Corporation and each of its directors and
executive officers (incorporated by reference to Exhibit 10.1 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.2 |
|
|
1995 Stock Option Plan (incorporated by reference to Exhibit 10.2 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.3 |
|
|
2005 Equity Incentive Plan (Amended and Restated May 23, 2007) (incorporated by reference to
Exhibit 10.1 to EpiCepts Current Report on Form 8-K filed May 30, 2007). |
|
|
|
|
|
|
10.4 |
|
|
2005 Employee Stock Purchase Plan (Incorporated by reference to Exhibit 10.4 of the Form S-4). |
|
|
|
|
|
|
10.5 |
|
|
Employment Agreement, dated as of October 28, 2004, between EpiCept Corporation and John V.
Talley (incorporated by reference to Exhibit 10.5 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.6 |
|
|
Employment Agreement, dated as of October 28, 2004, between EpiCept Corporation and Robert
Cook (incorporated by reference to Exhibit 10.6 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.7 |
|
|
License Agreement, dated as of December 18, 2003, between Endo Pharmaceuticals Inc. and
EpiCept Corporation (incorporated by reference to Exhibit 10.9 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.8 |
|
|
Royalty Agreement, dated as of July 16, 2003, between EpiCept Corporation and R. Douglas
Cassel, M.D. (incorporated by reference to Exhibit 10.10 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.9 |
|
|
Cooperation Agreement between APL American Pharmed Labs, Inc. and
Technologie-Beteiligungs-Gesellschaft mbH, dated August 1997 (incorporated by reference to
Exhibit 10.13 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.10 |
|
|
Investment Agreement between Pharmed Labs GmbH and Technologie-Beteiligungs-Gesellschaft mbH,
dated August 1997 (incorporated by reference to Exhibit 10.14 to the EpiCept Form S-1). |
F-31
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibits |
|
10.11 |
|
|
Investment Agreement among Pharmed Labs GmbH, American Pharmed Labs, Inc. and
Technologie-Beteiligungs-Gesellschaft mbH, dated February 17, 1998 (incorporated by reference
to Exhibit 10.15 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.12 |
|
|
Lease Agreement between BMR-Landmark at Eastview LLC, as Landlord, and EpiCept Corporation,
as Tenant, dated August 28, 2006 (incorporated by reference to Exhibit 10.12 to EpiCept
Corporations Annual Report on Form 10-K filed March 18, 2008). |
|
|
|
|
|
|
10.13 |
|
|
First Exchange Option Agreement, dated as of December 31, 1997, by and between American
Pharmed Labs, Inc. and tbg Technologie-Beteiligungs-Gesellschaft mbg der Deutschen
Ausgleichsbank (incorporated by reference to Exhibit 10.22 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.14 |
|
|
Second Exchange Option Agreement, dated as of February 17, 1998, by and between American
Pharmed Labs, Inc. and tbg Technologie-Beteiligungs-Gesellschaft mbh der Deutschen
Ausgleichsbank (incorporated by reference to Exhibit 10.23 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.15 |
|
|
Amendment to Second Exchange Option Agreement, dated as of August 26, 2005, by and between
EpiCept Corporation and tbg Technologie-Beteiligungs-Gesellschaft mbh der Deutschen
Ausgleichsbank (incorporated by reference to Exhibit 10.28 to the EpiCept Form S-4). |
|
|
|
|
|
|
10.16 |
|
|
Amended and Restated Note Purchase Agreement (the Note Purchase Agreement), dated as of
March 3, 2005, by and among EpiCept Corporation and the Purchasers indentified therein
(incorporated by reference to Exhibit 10.18 to the EpiCept Form S-1). |
|
|
|
|
|
|
10.17 |
|
|
Amendment No. 1 to License Agreement between EpiCept Corporation and DURECT Corporation,
dated as of September 12, 2008 (incorporated by reference to Exhibit 10.1 to EpiCept
Corporations Current Report on Form 8-K filed September 17, 2008). |
|
|
|
|
|
|
10.18 |
|
|
Loan and Security Agreement with Hercules Technology Growth Capital, Inc., dated August 30,
2008 (incorporated by reference to Exhibit 10.1 to EpiCept Corporations Current Report on
Form 10-Q filed November 9, 2006). |
|
|
|
|
|
|
10.19 |
|
|
First Amendment to the Loan and Security Agreement with Hercules Technology Growth Capital,
Inc., dated May 7, 2008 (incorporated by reference to Exhibit 10.1 to EpiCept Corporations
Current Report on Form 8-K filed May 9, 2008). |
|
|
|
|
|
|
10.20 |
|
|
Second Amendment to Loan and Security Agreement, by and among EpiCept Corporation, Maxim
Pharmaceuticals Inc. and Hercules Technology Growth Capital, Inc., dated as of June 23, 2008
(incorporated by reference to Exhibit 10.4 to EpiCept Corporations Current Report on Form
8-K filed June 23, 2008). |
|
|
|
|
|
|
10.21 |
|
|
Warrant Agreement with Hercules Technology Growth Capital, Inc., dated August 30, 2008
(incorporated by reference to Exhibit 10.2 to EpiCept Corporations Current Report on Form
10-Q filed November 9, 2006). |
|
|
|
|
|
|
10.22 |
|
|
Second Amendment to the Warrant Agreement with Hercules Technology Growth Capital, Inc.,
dated May 7, 2008 (incorporated by reference to Exhibit 10.2 to EpiCept Corporations Current
Report on Form 8-K filed
May 9, 2008). |
|
|
|
|
|
|
10.23 |
|
|
First Amendment to the Deposit Account Control Agreement with Hercules Technology Growth
Capital, Inc., dated May 7, 2008 (incorporated by reference to Exhibit 10.3 to EpiCept
Corporations Current Report on Form 8-K filed May 9, 2008). |
|
|
|
|
|
|
10.24 |
|
|
Common Stock Warrant, by and between EpiCept Corporation and Hercules Technology Growth
Capital, Inc., dated as of June 23, 2008 (incorporated by reference to Exhibit 10.6 to
EpiCept Corporations Current Report on Form 8-K filed June 23, 2008). |
|
|
|
|
|
|
10.25 |
|
|
Amendment to the Repayment Agreement by and between EpiCept Corporation and
Technologie-Beteiligungs Gesellschaft mbH der Deutschen Ausgleichsbank, dated May 23, 2008
(incorporated by reference to Exhibit 10.1 to EpiCept Corporations Current Report on Form
8-K filed May 28, 2008). |
F-32
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibits |
|
10.26 |
|
|
Securities Purchase Agreement, dated June 28, 2007 (incorporated by reference to Exhibit 10.1
to EpiCepts Current Report on Form 8-K filed June 29, 2007). |
|
|
|
|
|
|
10.27 |
|
|
Form of Warrant, dated as of June 28, 2007 (incorporated by reference to Exhibit 10.3 to
EpiCept Corporations Current Report on Form 8-K filed June 29, 2007). |
|
|
|
|
|
|
10.28 |
|
|
Securities Purchase Agreement, dated October 10, 2007 (incorporated by reference to Exhibit
10.1 to EpiCept Corporations Current Report on Form 8-K filed October 11, 2007). |
|
|
|
|
|
|
10.29 |
|
|
Form of Warrant, dated as of October 10, 2007 (incorporated by reference to Exhibit 10.2 to
EpiCept Corporations Current Report on Form 8-K filed October 11, 2007). |
|
|
|
|
|
|
10.30 |
|
|
Securities Purchase Agreement, dated December 4, 2007 (incorporated by reference to Exhibit
10.1 to EpiCept Corporations Current Report on Form 8-K filed December 5, 2007). |
|
|
|
|
|
|
10.31 |
|
|
Form of Common Stock Purchase Warrant, dated as of December 4, 2007 (incorporated by
reference to Exhibit 10.2 to EpiCept Corporations Current Report on Form 8-K filed December
5, 2007). |
|
|
|
|
|
|
10.32 |
|
|
Securities Purchase Agreement, dated March 6, 2008 (incorporated by reference to Exhibit 10.1
to EpiCept Corporations Current Report on Form 8-K dated March 6, 2008). |
|
|
|
|
|
|
10.33 |
|
|
Securities Purchase Agreement, dated as of June 23, 2008 (incorporated by reference to
Exhibit 10.1 to EpiCept Corporations Current Report on Form 8-K filed June 25, 2008). |
|
|
|
|
|
|
10.34 |
|
|
Form of Warrant, dated as of June 23, 2008 (incorporated by reference to Exhibit 10.6 to
EpiCept Corporations Current Report on Form 8-K filed June 23, 2008). |
|
|
|
|
|
|
10.35 |
|
|
Securities Purchase Agreement, dated July 15, 2008 (incorporated by reference to Exhibit 10.1
to EpiCept Corporations Current Report on Form 8-K filed July 16, 2008). |
|
|
|
|
|
|
10.36 |
|
|
Form of Warrant, dated as of July 15, 2008 (incorporated by reference to Exhibit 10.2 to
EpiCept Corporations Current Report on Form 8-K filed July 16, 2008). |
|
|
|
|
|
|
10.37 |
|
|
Securities Purchase Agreement, dated August 1, 2008 (incorporated by reference to Exhibit
10.1 to EpiCept Corporations Current Report on Form 8-K filed August 4, 2008). |
|
|
|
|
|
|
10.38 |
|
|
Form of Warrant, dated as of August 1, 2008 (incorporated by reference to Exhibit 10.2 to
EpiCept Corporations Current Report on Form 8-K filed August 4, 2008). |
|
|
|
|
|
|
10.39 |
|
|
Securities Purchase Agreement, dated August 11, 2008 (incorporated by reference to Exhibit
10.1 to EpiCept Corporations Current Report on Form 8-K filed August 12, 2008). |
|
|
|
|
|
|
10.40 |
|
|
Form of Warrant, dated as of August 11, 2008 (incorporated by reference to Exhibit 10.2 to
EpiCept Corporations Current Report on Form 8-K filed August 12, 2008). |
|
|
|
|
|
|
10.41 |
|
|
Securities Purchase Agreement, dated as of December 8, 2008 (incorporated by reference to
Exhibit 10.2 to EpiCept Corporations Current Report on Form 8-K filed December 9, 2008). |
|
|
|
|
|
|
10.42 |
|
|
2009 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.1 to EpiCept
Corporations Registration Statement on Form S-8 filed December 23, 2008). |
|
|
|
|
|
|
10.43 |
|
|
Second Amendment to the Repayment Agreement by and between EpiCept Corporation and
Technologie-Beteiligungs Gesellschaft mbH der Deutschen Ausgleichsbank, dated November 26,
2008 (incorporated by reference to Exhibit 10.1 to EpiCept Corporations Current Report on
form 8-K filed December 3, 2008). |
|
|
|
|
|
|
10.44 |
|
|
Placement Agent Agreement (incorporated by reference to Exhibit 10.1 to EpiCept Corporations
Current Report on form 8-K filed December 9, 2008) |
F-33
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibits |
|
10.45 |
|
|
Securities Purchase Agreement, dated as of February 4, 2009 (incorporated by reference to
Exhibit 10.1 to EpiCept Corporations Current Report on Form 8-K filed February 10, 2009). |
|
|
|
|
|
|
10.46 |
|
|
Form of Warrant (incorporated by reference to Exhibit 10.2 to EpiCept Corporations Current
Report on Form 8-K filed February 10, 2009). |
|
|
|
|
|
|
10.47 |
|
|
Placement Agent Agreement, dated February 4, 2009 (incorporated by reference to Exhibit 10.3
to EpiCept Corporations Current Report on Form 8-K filed February 10, 2009). |
|
|
|
|
|
|
10.48 |
|
|
Securities Purchase Agreement, dated as of June 18, 2009 (incorporated by reference to
Exhibit 10.1 to EpiCept Corporations Current Report on Form 8-K filed June 19, 2009). |
|
|
|
|
|
|
10.49 |
|
|
Form of Warrant (incorporated by reference to Exhibit 10.2 to EpiCept Corporations Current
Report on Form 8-K filed June 19, 2009). |
|
|
|
|
|
|
10.50 |
|
|
Placement Agent Agreement, dated June 18, 2009 (incorporated by reference to Exhibit 10.3 to
EpiCept Corporations Current Report on Form 8-K filed June 19, 2009). |
|
|
|
|
|
|
10.51 |
|
|
Amendment to the Repayment Agreement, dated June 25, 2009 (English translation from the
original German) (incorporated by reference to Exhibit 10.1 to EpiCept Corporations Current
Report on Form 8-K filed June 30, 2009). |
|
|
|
|
|
|
11.1 |
|
|
Statement Regarding Computation of Per Share Earnings (incorporated by reference to the Notes
to Consolidated Financial Statements included in Part II of this Report). |
|
|
|
|
|
|
21.1 |
* |
|
List of Subsidiaries of EpiCept Corporation. |
|
|
|
|
|
|
23.1 |
* |
|
Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm. |
|
|
|
|
|
|
31.1 |
** |
|
Certification of Chief Executive Officer, pursuant to Exchange Act Rules 13a-14(a) and
15(d)-14(a), adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
31.2 |
** |
|
Certification of Chief Financial Officer, pursuant to Exchange Act Rules 13a-14(a) and
15(d)-14(a), adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.1 |
** |
|
Certification of Chief Executive Officer, pursuant to 18 U.S.C. 1350, adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.2 |
** |
|
Certification of Chief Financial Officer, pursuant to pursuant to 18 U.S.C. 1350, adopted
Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
* |
|
Filed herewith. |
|
** |
|
Furnished herewith. |
|
|
|
Management contract or compensatory plan or arrangement |
(c) Financial Statements Schedules.
None.
F-34