UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2010
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-49839
Idenix Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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45-0478605 |
(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.) |
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60 Hampshire Street,
Cambridge, Massachusetts
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02139 (Zip Code) |
(Address of Principal Executive Offices)
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(617) 995-9800
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Common Stock, $0.001 par value
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The NASDAQ Global Market |
(Title of class)
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(Name of exchange on which registered) |
Securities registered pursuant to Section 12(g) of the Act:
NONE
Indicate by check mark if 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 if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the 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 (§232.405 of this chapter) 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 (§229.405) 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 amendment to the 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 the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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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 |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act). Yes o No þ
The aggregate market value of the voting and non-voting common stock held by
non-affiliates of the registrant based on the last reported sale price of the common stock on the
NASDAQ Global Market on June 30, 2010 was approximately $195.3 million. For this purpose, the
registrant considers its directors and officers and Novartis Pharma AG to be affiliates.
The number of shares outstanding of the registrants class of common stock as of February
15, 2011 was 73,106,487 shares.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement to be filed in connection with the solicitation of proxies
for the Annual Meeting of Stockholders to be held on June 2, 2011 are incorporated by reference
into Part III of this Annual Report on Form 10-K.
Idenix Pharmaceuticals, Inc.
Form 10-K
TABLE OF CONTENTS
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EX-10.60 Employment Letter, dated December 8, 2010, by and between the Registrant and Douglas L. Mayers, M.D. |
EX-10.61 Employment Letter, dated December 9, 2010, by and between the Registrant and David N. Standring, Ph.D. |
EX-10.62 Employment Letter, dated November 30, 2010, by and between the Registrant and Maria Stahl |
Exhibit 21.1 |
EX-23.1 Consent of PricewaterhouseCoopers LLP |
EX-31.1 CEO Cert Section 302 |
EX-31.2 CFO Cert Section 302 |
EX-32.1 CEO Cert Section 906 |
EX-32.2 CFO Cert Section 906 |
2
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act, as amended, concerning our business, operations and financial condition, including statements
with respect to the expected timing and results of completion of phases of development of our drug
candidates, the safety, efficacy and potential benefits of our drug candidates, expectations with
respect to development and commercialization of our drug candidates, expectations with respect to
licensing arrangements with a third-party, the timing and results of the submission, acceptance and
approval of regulatory filings, the scope of patent protection with respect to these drug
candidates and information with respect to the other plans and strategies for our business. All
statements other than statements of historical facts included in this Annual Report on Form 10-K
may be deemed as forward-looking statements. Without limiting the foregoing, expect,
anticipate, intend, may, plan, believe, seek, estimate, projects, will, would
and similar expressions or express or implied discussions regarding potential new products or
regarding future revenues from such products, potential future expenditures or liabilities or by
discussions of strategy, plans or intentions are also intended to identify forward-looking
statements, although not all forward-looking statements contain these identifying words. Because
these forward-looking statements involve known and unknown risks and uncertainties, actual results,
performance or achievements could differ materially from those expressed or implied by these
forward-looking statements for a number of important reasons, including those discussed under Risk
Factors, Managements Discussion and Analysis of Financial Condition and Results of Operations
and elsewhere in this Annual Report on Form 10-K. In particular, managements expectations could be
affected by, among other things, uncertainties involved in the development of new pharmaceutical
products, including unexpected clinical trial results; unexpected regulatory actions or delays or
government regulation generally; our ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; government, industry and general public
pricing pressures; and uncertainties regarding necessary levels of expenditures in the future.
There can be no guarantee that development of any drug candidates described will succeed or that
any new products will obtain necessary regulatory approvals required for commercialization or
otherwise be brought to market. Similarly, there can be no guarantee that we or one or more of our
current or future products, if any, will achieve any particular level of revenue.
You should read these forward-looking statements carefully because they discuss our
expectations regarding our future performance, future operating results or future financial
condition, or state other forward-looking information. You should be aware that the occurrence of
any of the events described under Risk Factors and elsewhere in this Annual Report on Form 10-K
could substantially harm our business, results of operations and financial condition and that upon
the occurrence of any of these events, the price of our common stock could decline.
We cannot guarantee any future results, levels of activity, performance or achievements.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those described in this Form 10-K as
anticipated, believed, estimated or expected. The forward-looking statements contained in this
Annual Report on Form 10-K represent our expectations as of the date of this Annual Report on Form
10-K (unless another date is indicated) and should not be relied upon as representing our
expectations as of any other date. While we may elect to update these forward-looking statements,
we specifically disclaim any obligation to do so, even if our expectations change.
3
PART I
Overview
Idenix Pharmaceuticals, Inc., which we refer to as Idenix, we, us or our, is a
biopharmaceutical company engaged in the discovery and development of drugs for the treatment of
human viral diseases with operations in the United States and Europe. Currently, our primary
research and development focus is on the treatment of hepatitis C virus, or HCV. HCV is a leading
cause of liver disease. According to the World Health Organization, HCV is responsible for 50% to
76% of all liver cancer cases worldwide and two thirds of all liver transplants in the developed
world. The World Health Organization also has estimated that approximately 180 million people
worldwide are chronically infected with HCV and an additional three to four million people are
infected each year. We believe that large market opportunities exist for new treatments of HCV
because the current treatment with pegylated interferon in combination with ribavirin is poorly
tolerated and only effective in about half of patients infected with HCV genotype 1, the most
common strain of the virus. Our strategic goal is to develop all oral combinations of direct-acting
antiviral, or DAA, drug candidates that will eliminate the need for interferon and/or ribavirin.
Our objective is to develop low dose, once- or twice-daily agents with broad genotypic activity
that have low potential for drug-drug interaction, high tolerability and are designed for use in
multiple combination regimens. We will seek to build a combination development strategy, both
internally and with partners, to advance the future of HCV treatments.
Business Highlights
Our HCV discovery program is focused on a combination DAA strategy with multiple classes of
drugs, which include nucleoside/nucleotide polymerase inhibitors, protease inhibitors,
non-nucleoside polymerase inhibitors and NS5A inhibitors:
Combination DAA Strategy. In July 2010, we conducted a 14-day phase I drug-drug interaction
study with two of our HCV drug candidates, IDX184 and IDX320, in 20 healthy volunteers. In
September 2010, the U.S. Food and Drug Administration, or FDA, placed these drug candidates on
clinical hold due to three serious adverse events of elevated liver function tests that were
detected during post drug exposure safety visits following the 14-day drug-drug interaction study.
We believe the hepatotoxicity observed in this drug-drug interaction study was caused by IDX320
and therefore discontinued the clinical development of this drug candidate. In February 2011, the
full clinical hold on IDX184 was removed. The program was placed on partial clinical hold, which
allows us to initiate a phase IIb 12-week clinical trial of IDX184 in combination with pegylated
interferon and ribavirin, or Peg-IFN/RBV, with safety evaluations of the patients that will be
shared with the FDA at certain intervals in the trial. We anticipate initiating this clinical
trial in the second half of 2011.
Nucleoside/Nucleotide Polymerase Inhibitors. The most advanced of our development programs
is IDX184, a novel liver-targeted nucleotide prodrug candidate. In the third quarter of 2010, we
completed a 14-day dose-ranging phase IIa clinical trial evaluating IDX184 in combination with
Peg-IFN/RBV in treatment-naive HCV genotype 1-infected patients. This clinical trial demonstrated
that IDX184 is generally safe, well tolerated and has potent HCV antiviral activity. In February
2011, the FDA removed the full clinical hold on IDX184, originally imposed in September 2010, as
discussed above, and the program was placed on partial clinical hold. The partial clinical hold
allows us to initiate a phase IIb 12-week clinical trial of IDX184 in combination with Peg-IFN/RBV
with safety evaluations of the patients that will be shared with the FDA at certain intervals in
the trial. We anticipate initiating this clinical trial in the second half of 2011. We believe
that nucleosides/nucleotides will have a significant role in a combination DAA strategy for the
treatment of HCV and therefore we are currently concentrating a substantial amount of our
discovery efforts on this class of drugs. We believe we have strong nucleoside/nucleotide
scientific expertise within our organization and should be able to leverage our intellectual
patent portfolio to discover multiple follow-ons and novel nucleoside/nucleotide drug candidates.
Protease Inhibitors. Our lead clinical candidate from our protease inhibitor discovery
program was IDX320, a non-covalent macrocyclic inhibitor. In the first quarter of 2010, we
completed a double-blind, placebo-controlled phase I clinical study evaluating single and multiple
ascending doses of IDX320 in healthy volunteers. Based on the favorable safety and pharmacokinetic
data from the phase I clinical study, we initiated a three-day proof-of-concept clinical trial in
treatment-naïve HCV genotype 1-infected patients, which was completed in the third quarter of
2010. This three-day clinical trial demonstrated that IDX320 had potent HCV antiviral activity.
The IDX320 program was discontinued following the three serious adverse events of liver injury in
the 14-day phase I drug-drug interaction study of IDX184 and IDX320, discussed above. We have
follow-on drug candidates in the protease inhibitor class that are currently in preclinical
development. We anticipate selecting a clinical candidate with broad genotypic activity in 2011.
Non-Nucleoside Polymerase Inhibitors. Our lead drug candidate for our non-nucleoside
inhibitor program is IDX375, a novel palm-binding polymerase inhibitor. In the first quarter of
2010, we submitted a clinical trial application, or CTA, for a free acid form of IDX375. In the
fourth quarter of 2010, we completed a phase I clinical study evaluating single and multiple doses
of IDX375 in healthy volunteers. Based on the favorable safety and pharmacokinetic data from the
phase I clinical study, we initiated a three-day proof-of-concept clinical trial in
treatment-naïve genotype 1-infected patients in the fourth quarter of 2010. After three days of
dosing with 100 mg, 200 mg and 400 mg of IDX375 administered twice a day (BID), mean HCV viral
load reductions were 1.3, 2.3 and 2.7 log10 IU/mL, respectively. Overall, IDX375 was
generally safe and well tolerated at the three doses tested.
4
NS5A Inhibitors. During 2010, we selected two lead candidates from our NS5A discovery
program. We anticipate selecting a clinical candidate with broad genotypic activity and submitting
an investigational new drug, or IND, or a CTA in 2011, assuming positive results from IND-enabling
preclinical studies.
In April 2010, we issued approximately 6.5 million shares of our common stock pursuant to an
underwritten offering and received $26.3 million in net proceeds.
In February 2009, we licensed our drug candidates from the class of compounds known as
non-nucleoside reverse transcriptase inhibitors, or NNRTIs, including IDX899, on a worldwide basis
to GlaxoSmithKline for the treatment of human diseases, including human immunodeficiency virus
type-1, or HIV, and acquired immune deficiency syndrome, or AIDS. We refer to this agreement as the
GSK license agreement. In October 2009, GlaxoSmithKline assigned the GSK license agreement to
ViiV Healthcare Company, an affiliate of GlaxoSmithKline, which we refer to collectively as GSK.
Under the GSK license agreement, in 2010, we received a $6.5 million milestone payment for the
achievement of a preclinical operational milestone and a $20.0 million milestone payment for the
initiation of a phase IIb clinical study related to the development of GSK2248761, or 761
(formerly IDX899). Under the GSK license agreement, we could potentially receive up to $390.0
million in additional milestone payments as well as double-digit tiered royalties on worldwide
product sales. In February 2011, GSK informed us that the FDA placed 761 on clinical hold. GSK has
full responsibility for the development of 761, including any regulatory interaction.
On October 28, 2010, Jean-Pierre Sommadossi, Ph.D. resigned from his positions as chairman of
the board of directors, president and chief executive officer. In connection with Dr. Sommadossis
resignation, he will receive severance payments of approximately $2.3 million, an option grant of
approximately 0.3 million shares and acceleration of all unvested options. Additionally, on October
28, 2010, the board of directors appointed Ronald C. Renaud, Jr., to serve as president and chief
executive officer.
Novartis Collaboration
In May 2003, we entered into a collaboration with Novartis relating to the worldwide
development and commercialization of our drug candidates, which we refer to as the development and
commercialization agreement. In addition, Novartis also purchased approximately 54% of our
outstanding capital stock in May 2003. Under the development and commercialization agreement, we
successfully developed and received worldwide marketing approval for telbivudine (Tyzeka®/Sebivo®),
a drug for the treatment of hepatitis B virus, or HBV, that we licensed to Novartis Pharma AG, or
Novartis. In 2007, we began receiving royalties from Novartis based on a percentage of net sales of
Tyzeka®/Sebivo®. As part of this agreement, Novartis has an option to license any of our
development-stage drug candidates after demonstration of activity and safety in a proof-of-concept
clinical trial so long as Novartis maintains at least 40% ownership of our common stock. As of
February 15, 2011, Novartis owned approximately 43% of our outstanding common stock. In October
2009, Novartis waived its option to license IDX184. As a result, we retain the worldwide rights to
develop, manufacture, commercialize and license IDX184. We are currently seeking a partner who will
assist in the future development and commercialization of this drug candidate.
Products and Drug Candidates
Hepatitis C
HCV Background
There are multiple drug classes that we are developing to inhibit HCV replication:
nucleoside/nucleotide polymerase inhibitors, protease inhibitors, non-nucleoside polymerase
inhibitors and NS5A inhibitors.
Nucleoside/Nucleotide Polymerase Inhibitors. During HCV replication, the viral polymerase,
also called the NS5B polymerase, is the key enzyme that replicates the viral genetic information
contained in the HCV viral genetic material, which is known as viral ribonucleic acid, or RNA, and
is therefore essential for the virus to reproduce itself. Nucleosides/nucleotides are small,
natural chemical compounds that function as the building blocks of human and viral genetic
material. Nucleoside polymerase inhibitors prevent HCV replication by interfering with the activity
of the viral polymerase. Mimicking the role of natural nucleosides, nucleoside polymerase
inhibitors bind directly to the active site of the polymerase and are incorporated by viral
polymerases into replicating viral genomes. This event leads to chain termination, preventing the
virus from reproducing its genetic material. As drugs, nucleosides/nucleotides have a proven record
of success as antiviral agents and generally offer selectivity, antiviral activity, a high barrier
to resistance, long duration of action and the potential for convenient oral administration. As a
result, nucleosides/nucleotides may be particularly well suited for the treatment of chronic viral
diseases.
Protease Inhibitors. HCV proteins are initially created as one long protein that is then cut
into smaller, individual, functional proteins by protease enzymes such as the HCV NS3/4A protease.
These smaller proteins then assemble to form a replication complex that reproduces the viral
genetic material. HCV protease inhibitors interfere with the cutting of the initial long protein,
thus blocking the formation of the replication complex and preventing HCV replication.
5
Non-Nucleoside Polymerase Inhibitors. Non-nucleoside polymerase HCV inhibitors bind to the
NS5B polymerase at allosteric sites. At least four such allosteric sites exist on the polymerase;
within the non-nucleoside inhibitor class, there are distinct structural types that enable
binding to these different sites. Binding of these inhibitors to the polymerase results in
inhibition of the enzyme activity and therefore inhibition of HCV RNA synthesis and replication.
NS5A Inhibitors. NS5A is a multifunctional, nonstructural HCV protein that is important for
the formation of viral replication complexes, the process of viral replication and virus assembly.
We believe that NS5A inhibitor agents could complement protease and polymerase inhibitors in future
HCV combination regimens.
We believe that combining two or more direct-acting HCV antiviral agents, particularly agents
directed against different HCV targets, could lead to a more potent inhibition of HCV replication
and to a better suppression of the emergence of drug resistance compared to the use of single
agents or two agents directed against the same HCV target. A DAA combination regimen approach would
expand the treatable HCV population by including those patients who cannot be treated with
interferon-based therapies or those for whom existing treatment regimens have been ineffective. We
believe that with a critical mass of HCV drug candidates in development from the major HCV drug
classes, we are well positioned to play a role in future combination HCV treatments.
Combination DAA Development
In July 2010, we conducted a 14-day phase I, randomized, double-blind, placebo-controlled
study to evaluate the pharmacokinetic drug-drug interaction between IDX184 and IDX320 in 20 healthy
volunteers. Two cohorts were evaluated in the study with 10 subjects in each cohort randomized
eight to active drug and two to placebo. Subjects in the first cohort received 400 mg once-daily
(QD) of IDX320 plus placebo for the first week, subsequently adding 100 mg QD of IDX184 for the
second week. Subjects in the second cohort received 100 mg QD of IDX184 plus placebo for the first
week, subsequently adding 400 mg QD of IDX320 for the second week. There was no clinically
significant pharmacokinetic drug-drug interaction between IDX184 and IDX320 observed in this study.
There were no adverse events or laboratory abnormalities observed during the two weeks of drug
exposure. There were three serious adverse events of elevated liver function tests that were
detected during post drug exposure safety visits following the 14-day drug-drug interaction study.
The liver function tests returned to normal levels in the three subjects during follow-up visits.
Due to these serious adverse events, in September 2010, the FDA placed IDX184 and IDX320 on
clinical hold. We believe the hepatotoxicity observed in this drug-drug interaction study was
caused by IDX320 and therefore discontinued the clinical development of this drug candidate. In
February 2011, the full clinical hold on IDX184 was removed by the FDA. The program was placed in
partial clinical hold, which allows us to initiate a phase IIb 12-week clinical trial of IDX184 in
combination with Peg-IFN/RBV with safety evaluations of the patients that will be shared with the
FDA at certain intervals in the trial. We anticipate initiating this clinical trial in the second
half of 2011.
Nucleoside/Nucleotide Polymerase Inhibitors Development
IDX184 is a novel liver-targeted nucleotide prodrug that enables the delivery of nucleoside
monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate,
thus potentially maximizing drug efficacy and limiting systemic side effects. IDX184 has
demonstrated activity across multiple HCV genotypes, a high barrier to resistance and synergy with
ribavirin in vitro.
In October 2008, we successfully completed a phase I clinical study, which demonstrated
favorable pharmacokinetics and safety properties in healthy volunteers, and we subsequently
initiated a proof-of-concept clinical trial. We successfully completed the proof-of-concept
clinical trial in treatment-naïve HCV genotype 1-infected patients in July 2009. In the fourth
quarter of 2009, we initiated a phase IIa clinical trial for IDX184. The clinical study was a
randomized, double-blind, placebo-controlled, sequential cohort, dose-escalation study evaluating
the safety, tolerability, pharmacokinetics and antiviral activity of IDX184 in combination with
Peg-IFN/RBV in treatment-naïve HCV genotype 1-infected patients. Patients received a daily dose of
IDX184 or placebo plus Peg-IFN/RBV for 14 days and continued on Peg-IFN/RBV for an additional 14
days. All patients in the study had the option to continue Peg-IFN/RBV for up to 48 weeks. Four
dosing regimens of IDX184 ranging from 50 mg to 200 mg per day were evaluated. In the 100 mg and
200 mg cohorts, QD or BID regimens were compared. Each cohort of the study evaluated 20 patients
randomized four to IDX184 and one to placebo. IDX184, at doses at or above 100 mg combined with
Peg-IFN/RBV at 14 days, demonstrated similar antiviral activity. Mean HCV RNA reductions ranged
from 3.7 to 4.3 log10 IU/mL and 29% to 50% of subjects achieved undetectable HCV RNA
levels compared to 1.5 log10 IU/mL reduction in the placebo plus Peg-IFN/RBV. Alanine
aminotransferase, or ALT, and aspartate aminotransferase, or AST, levels, which are markers for
liver injury, improved significantly faster in patients treated with IDX184 and Peg-IFN/RBV as
compared to patients receiving only Peg-IFN/RBV. At daily doses of IDX184 up to 200 mg in
combination with Peg-IFN/RBV for 14 days, the side effect profile of IDX184 combined with
Peg-IFN/RBV has been consistent with the known side effect profile of Peg-IFN/RBV.
As previously discussed, in September 2010, the FDA placed IDX184 and IDX320 on clinical hold
and in February 2011, the full clinical hold on IDX184 was removed. The program was placed on
partial clinical hold, which allows us to initiate a phase IIb 12-week clinical trial of IDX184 in
combination with Peg-IFN/RBV with safety evaluations of the patients that will be shared with the
FDA at certain intervals in the trial. We anticipate initiating this clinical trial in the second
half of 2011.
6
In October 2009, Novartis waived its option to license IDX184 under the development and
commercialization agreement. As a result, we retain the worldwide rights to develop, manufacture,
commercialize and license IDX184. We are currently seeking a partner who will assist in the future
development and commercialization of this drug candidate.
We believe that
nucleosides/nucleotides will have a significant role in a combination DAA
strategy for the treatment of HCV and therefore we are currently concentrating a substantial amount
of our discovery efforts on this class of drugs. We believe we have strong nucleoside/nucleotide
scientific expertise within our organization and should be able to leverage our intellectual patent
portfolio to discover multiple follow-ons and novel nucleoside/nucleotide drug candidates.
Protease Inhibitors Development
IDX320 is a non-covalent macrocyclic inhibitor with nanomolar potency, broad genotypic
coverage and a favorable toxicological and preclinical pharmacokinetic profile supporting the
potential for once-daily dosing in patients.
We completed a phase I healthy volunteer clinical study in the first quarter of 2010. This
double-blind, placebo-controlled study demonstrated favorable safety and pharmacokinetic data. In
June 2010, we initiated a proof-of-concept trial in HCV-infected patients. The study evaluated four
doses of IDX320, ranging from 50 mg to 400 mg QD, and one 200 mg BID administered for three days.
Each cohort of the study evaluated eight patients randomized six to IDX320 and two to
placebo. This three-day clinical trial demonstrated that IDX320 had potent HCV antiviral
activity. Patients had mean HCV viral load reductions of 0.04, 2.6, 3.1, 3.1, 3.3 and 3.8
log10 IU/mL in the placebo, 50 mg, 100 mg, 200 mg, 400 mg QD and 200 mg BID cohorts,
respectively. There were asymptomatic grade 1 and grade 2 elevations of total bilirubin in the 200
mg BID cohort due to increased direct bilirubin. There were no other discernable patterns of
adverse events or laboratory abnormalities.
The IDX320 program was discontinued following the three serious adverse events of liver injury
in the 14-day phase I drug-drug interaction study of IDX184 and IDX320, discussed above.
We have follow-on drug candidates in the protease inhibitor class that are currently in
preclinical development. We anticipate selecting a clinical candidate with broad genotypic activity
in 2011.
Non-Nucleoside Polymerase Inhibitors Development
IDX375 is a novel palm-binding polymerase inhibitor that has demonstrated a favorable
preclinical pharmacokinetic profile in several species, high liver to plasma concentrations in
rodents and adequate safety in animal studies.
In September 2009, we submitted a CTA for a choline salt form of our lead clinical candidate,
IDX375. We initiated a single ascending dose phase I clinical study evaluating the safety,
tolerability and pharmacokinetics of IDX375 in healthy volunteers in November 2009. The study was a
randomized, double-blind, placebo-controlled study with five dosing regimens of IDX375 ranging from
25 mg QD to 200 mg BID for one day. Each cohort of the study evaluated eight subjects randomized
six to IDX375 and two to placebo. The data demonstrated favorable plasma exposure of IDX375 with a
long elimination half-life of approximately 30 to 40 hours suggesting the potential for once- or
twice-daily dosing in patients. IDX375 was well tolerated and demonstrated a favorable safety
profile. There were no significant laboratory abnormalities. The most common adverse event was mild
diarrhea (3/30 subjects).
In the first quarter of 2010, we submitted a CTA for a free acid form of IDX375. The active
pharmaceutical ingredient, or API, as a free acid allows improved manufacturing processes and
long-term stability of the drug product, providing more diverse formulation options. During 2010,
we continued the phase I clinical study evaluating single and multiple doses of the free acid form
of IDX375 in healthy volunteers. This clinical study was completed in the fourth quarter of 2010
and demonstrated favorable safety and pharmacokinetics properties. In the fourth quarter of 2010,
we initiated a three-day proof-of-concept clinical trial in treatment-naïve genotype 1-infected
patients. Patients received twice daily doses of IDX375 or placebo plus Peg-IFN/RBV for three days.
All patients in the study had the option to continue Peg-IFN/RBV for up to 48 weeks. Three dosing
regimens of IDX375 of 100 mg, 200 mg and 400 mg BID were evaluated. Each cohort of the study
evaluated 10 patients randomized eight to IDX375 and two to placebo. After three days of dosing
with 100 mg, 200 mg and 400 mg BID of IDX375 with Peg-IFN/RBV, mean HCV viral load reductions were
1.3, 2.3 and 2.7 log10 IU/mL, respectively, whereas patients who received placebo
experienced an increase of 0.1 log10 IU/mL. In this three-day study of IDX375, the
exposure in HCV-infected patients was comparable to healthy volunteers and IDX375 was safe and well
tolerated.
NS5A Inhibitors Development
During 2010, we selected two lead candidates from our NS5A discovery program. We anticipate
selecting a clinical candidate with broad genotypic activity and submitting an IND or a CTA in
2011, assuming positive results from IND-enabling preclinical studies.
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HIV
In addition to our HCV discovery and development program, we have also developed an NNRTI drug
candidate, IDX899, for the treatment of HIV/AIDS for use in combination therapy. In 2008, we
successfully completed a proof-of-concept clinical trial of IDX899 in treatment-naïve HIV-infected
patients. In February 2009, we granted GSK an exclusive worldwide license to develop, manufacture
and
commercialize our NNRTI compounds, including IDX899, for the treatment of human diseases,
including HIV/AIDS. In 2009, GSK performed long-term chronic toxicology studies and drug-drug
interaction studies in healthy volunteers with IDX899, now known as 761, which demonstrated a
favorable safety and drug-drug profile. In the fourth quarter of 2010, GSK initiated a phase IIb
clinical study of 761 in HIV-infected patients. In February 2011, GSK informed us that the FDA
placed 761 on clinical hold. GSK has full responsibility for the development of 761, including
any regulatory interactions.
Hepatitis B
In collaboration with Novartis, we developed telbivudine (Tyzeka®/Sebivo®) through
commercialization for the treatment of patients with HBV. In October 2006, the FDA approved Tyzeka®
in the United States and Sebivo® was approved in 2007 in more than 50 countries outside the United
States, including major Asian countries and several countries included in the European Union. In
October 2007, we transferred to Novartis our worldwide development, commercialization and
manufacturing rights and obligations related to telbivudine in exchange for royalty payments equal
to a percentage of net sales, with such percentage increasing according to specified tiers of net
sales. Since the fourth quarter of 2007, Novartis has been solely responsible for clinical trial
costs and related expenditures associated with telbivudine.
Antiviral Research
Our scientists have a highly developed set of skills in compound generation, target selection,
screening and pharmacology, preclinical development and lead optimization. We are utilizing these
skills and capabilities in our discovery and development of antiviral drug candidates.
Our Scientists
Our scientists are engaged in drug discovery and development. Our scientists have expertise in
the areas of medicinal chemistry, molecular virology and pharmacology. They also have substantial
experience in applying this expertise to the discovery and development of nucleoside/nucleotide,
protease, non-nucleoside and NS5A inhibitors which target the viral replication cycle.
Focused Compound Library
Our focused compound library contains a diverse set of structures, which have been synthesized
for the principal purpose of targeting and inhibiting viral replication. These structures consist
of various nucleosides, nucleoside analogs, nucleotides, selected non-nucleosides and other small
molecule compounds, including protease and NS5A inhibitors. In addition to our focused library, we
have engaged with other entities to obtain rights to libraries comprised of a significant number of
compounds that may have utility targeting and inhibiting viral replication.
Target Selection
We focus on viral diseases representing large and growing market opportunities with
significant unmet medical needs. Our selection of a particular therapeutic target within those
viral diseases takes into consideration the experience and expertise of our scientific management
team, and the potential that our nucleoside analog, nucleotide, non-nucleoside, protease inhibitor
and NS5A inhibitor libraries, and those libraries to which we have access, could yield a small
molecule lead. The final selection is based on the possibility of being able to generate robust
medicinal chemistry structure-activity relationships to assist lead optimization and secure
relevant intellectual property rights.
Screening
We believe that our efficiency in selecting a lead chemical structure from our focused
library, and the libraries which we access, distinguishes us from our competitors. Our ability to
synthesize multiple compounds with antiviral activity in our Montpellier, France facility enhances
early progress toward lead optimization in our Cambridge, Massachusetts facilities.
Pharmacology, Preclinical Development and Lead Optimization
Once we have identified lead compounds, they are tested using in vitro and in vivo
pharmacology studies and in vivo animal models of antiviral efficacy. Using in vitro studies, our
scientists are able to ascertain the relevance of intracellular activation, metabolism and protein
binding. The in vivo pharmacokinetic studies identify the percentage of oral bioavailability and
whole body metabolism of the compound. The animal models provide data on the efficacy of the
compound and firmly establish a proof-of-concept in a biologically relevant system.
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Collaborations
Novartis Collaboration
On May 8, 2003, we entered into a collaboration with Novartis, which included the following
agreements and transactions:
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the development and commercialization agreement, under which we
collaborate with Novartis to develop, manufacture and commercialize
our drug candidates which it licenses from us; |
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the manufacturing and supply agreement, under which Novartis
manufactured for us the API for the clinical development and
commercial supply of drug candidates it licensed from us and the
finishing and packaging of licensed products for commercial sale; |
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the stockholders agreement, which was subsequently amended and
restated in July 2004 in connection with the closing of our initial
public offering; and |
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the stock purchase agreement, under which Novartis purchased
approximately 54% of our outstanding capital stock from our then
existing stockholders for $255.0 million in cash, with an additional
aggregate amount of up to $357.0 million contingently payable to these
stockholders if we achieve predetermined milestones with respect to
the development of specific HCV drug candidates, including
valopicitabine, which we ceased developing in July 2007, and prodrugs. |
In July 2004 and October 2005, in connection with our public offerings, Novartis purchased
from us additional shares of our common stock to maintain its equity interest following each
offering. Specifically, Novartis purchased 5.4 million shares of our common stock for an aggregate
purchase price of $75.6 million in connection with our July 2004 initial public offering and
approximately 3.9 million shares of common stock for an aggregate purchase price of $81.2 million
in connection with our October 2005 public offering. Additionally, in connection with the
consummation of our initial public offering, we sold to Novartis 1.1 million shares of common stock
for a purchase price of $0.001 per share in exchange for the termination of certain stock
subscription rights held by Novartis. Novartis did not purchase shares of our common stock pursuant
to our underwritten offerings in August 2009 and in April 2010 and Novartis ownership was
subsequently diluted from approximately 53% prior to the August 2009 offering to approximately 43%
as of February 15, 2011.
Development and Commercialization Agreement
Designation of Products
As part of the development and commercialization agreement with Novartis, Novartis has an
option to license any of our development-stage drug candidates after demonstration of activity and
safety in a proof-of-concept clinical trial so long as Novartis maintains at least 40% ownership of
our common stock. The terms of these options, including license fees, milestone payments and
payments in reimbursement of development expenses, vary according to the disease which the drug
candidate treats, the stage of development of the drug candidate and the projected product
valuation based on market research and sales forecasts.
In 2003, Novartis licensed telbivudine from us for the treatment of HBV. In September 2007, we
entered into an amendment to the development and commercialization agreement, which we refer to as
the 2007 amendment. Pursuant to the 2007 amendment, we transferred to Novartis worldwide
development, commercialization and manufacturing rights and obligations pertaining to telbivudine
(Tyzeka®/Sebivo®). Subsequently, we began receiving royalty payments equal to a percentage of net
sales of Tyzeka®/Sebivo®. The royalty percentage varies based on the specified territory and the
aggregate dollar amount of net sales.
In February 2009, Novartis waived its option to license any of our NNRTI compounds, including
IDX899, which allowed us to enter into the GSK license agreement. As part of the GSK transaction,
we amended the development and commercialization agreement with Novartis such that Novartis retains
the exclusive option to license other drug candidates developed by us, or in some cases licensed to
us, so long as Novartis maintains ownership of 40% of our voting stock rather than ownership of 51%
of our voting stock, as was initially agreed to by the parties in 2003.
In October 2009, Novartis waived its option to license IDX184 and as a result, we retain the
worldwide rights to develop, manufacture, commercialize and license IDX184. We are currently
seeking a partner who will assist in the future development and commercialization of this drug
candidate.
Development of Products and Regulatory Activities
For the drug candidates Novartis chooses to license, Novartis will have the right to approve,
in its reasonable discretion, the corresponding development budget. Each licensed product will be
developed in accordance with a development plan approved by a joint steering committee, which is
comprised of an equal number of representatives from Idenix and Novartis. Novartis will also be
responsible for certain development expenses incurred in accordance with approved development
budgets for the licensed products. The development and commercialization agreement has several
joint committees in which we and Novartis participate. We participate in these committees as a
means to govern or protect our interests. The committees span the period from early development
through commercialization of drug candidates licensed by Novartis.
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We have primary responsibility for preparing and filing regulatory submissions with respect to
any licensed product in the United States and Novartis has primary responsibility in all other
countries in the world. Under certain circumstances, primary responsibilities for all or
certain regulatory tasks in a particular country may be switched from one party to the other.
Product Sales Arrangement
In connection with the drug candidates that Novartis licenses from us, with the exception of
Tyzeka®/Sebivo®, we have retained the right to co-promote or co-market in the United States, United
Kingdom, France, Germany, Italy and Spain. In the United States, we would act as the lead
commercial party, record revenue from product sales and share equally the resulting net benefit
from co-promotion from the date of product launch. In the United Kingdom, France, Germany, Italy
and Spain, Novartis would act as the lead commercial party, record revenue from product sales and
would share with us the net benefit from co-promotion and co-marketing. The net benefit is defined
as net product sales minus related cost of sales. In the United Kingdom, France, Germany, Italy and
Spain, the net benefit that would be shared with us would increase incrementally during the first
three years from the date of product launch, such that we would share equally with Novartis
beginning in the third year from the date of product launch. In other countries, we would
effectively sell products to Novartis for their further sale to third-parties. Novartis would pay
us for such products at a price that is determined under the terms of our manufacturing and supply
agreement with Novartis and we would receive a royalty payment from Novartis on net product sales.
Under the terms of the development and commercialization agreement, Novartis has the right to
market, sell or promote any product that competes with the products that Novartis licenses from us.
Indemnification
Under the development and commercialization agreement, we have agreed to indemnify Novartis
and its affiliates against losses suffered as a result of our breach of representations and
warranties in that agreement. We made numerous representations and warranties to Novartis regarding
our HBV and HCV drug candidates, including representations regarding our ownership of the
inventions and discoveries associated with such candidates. If one or more of the representations
or warranties were not true at the time they were made to Novartis, we would be in breach of this
agreement. In the event of a breach by us, Novartis has the right to seek indemnification from us
for damages suffered as a result of such breach. The amounts for which we could be liable to
Novartis could be substantial. For additional information on such indemnification rights, see
Stock Purchase Agreement, Risk Factors Factors Related to Our Relationship with Novartis and
Risk Factors Factors Related to Patents and Licenses.
Termination
Novartis may terminate, in its sole discretion, the development and commercialization
agreement with respect to a particular product, drug candidate or country by providing us with six
months written notice. In addition, if either we or Novartis materially breach the development and
commercialization agreement and do not cure such breach within 30 days, or under certain
circumstances, 120 days, or if such breach is incurable, the non-breaching party may terminate the
development and commercialization agreement with respect to: a) the particular product, drug
candidate or country to which the breach relates; or b) in its entirety, if the material breach is
not limited to a particular product, drug candidate or country.
Each party may also terminate the development and commercialization agreement in its entirety
upon 30 days written notice if the other party files for bankruptcy, insolvency, reorganization or
the like. If Novartis terminates the agreement for material breach by us or for bankruptcy,
insolvency or reorganization on our part, then Novartis may elect to retain licenses to drug
candidates or products, in which case it will remain obligated to make payments to us in amounts to
be negotiated in good faith at the time of termination. If we terminate part or all of the
agreement for material breach by Novartis or for bankruptcy, insolvency or reorganization on the
part of Novartis, or if Novartis terminates the agreement unilaterally in the absence of a breach
by us, we may be obligated to make payments to Novartis in amounts to be negotiated in good faith
at the time of termination.
Manufacturing and Supply Agreement
Under the master manufacturing and supply agreement, dated May 8, 2003, with Novartis, we
appointed Novartis to manufacture or have manufactured the clinical supply of the API for each drug
candidate licensed under the development and commercialization agreement and certain other drug
candidates. The cost of the clinical supply will be treated as a development expense, allocated
between us and Novartis in accordance with the agreement. We have the ability to appoint Novartis
or a third-party to manufacture the commercial supply of the API based on a competitive bid process
under which Novartis has the right to match the best third-party bid. Novartis will perform the
finishing and packaging of the API into the final form for sale.
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Stockholders Agreement
In connection with Novartis purchase of our stock from our then existing stockholders, we and
substantially all of our stockholders entered into the stockholders agreement with Novartis, which
was amended and restated in 2004 in connection with our initial public offering. Under the terms of
the amended and restated stockholders agreement, we have:
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granted Novartis, together with certain other holders of our common
stock, rights to cause us to register, under the Securities Act of
1933, as amended, such shares of common stock; |
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agreed to use our reasonable best efforts to nominate for election as
directors at least two designees of Novartis for so long as Novartis
and its affiliates own at least 35% of our voting stock and at least
one designee of Novartis for so long as Novartis and its affiliates
own at least 19.4% of our voting stock; and |
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granted Novartis approval rights over a number of corporate actions
that we or our subsidiaries may take as long as Novartis and its
affiliates continue to own at least 19.4% of our voting stock. |
Novartis Stock Subscription Rights
Novartis has certain rights to acquire shares of our capital stock. Such rights are further
described below under the heading Managements Discussion and Analysis of Financial Condition and
Results of Operations Critical Accounting Policies and Estimates.
Stock Purchase Agreement
On March 21, 2003, Novartis, substantially all holders of our capital stock as of May 8, 2003
and Idenix entered into the stock purchase agreement. Under the stock purchase agreement, Novartis
purchased approximately 54% of our outstanding capital stock from our stockholders for $255.0
million in cash, with an additional aggregate amount of up to $357.0 million contingently payable
to these stockholders if we achieve predetermined development milestones with respect to specific
HCV drug candidates. The future contingent payments are payable in cash or, under certain
circumstances, Novartis AG American Depository Shares.
Under the stock purchase agreement, we agreed to indemnify Novartis and its affiliates against
losses suffered as a result of our breach of representations and warranties in that agreement. In
the stock purchase agreement, we and our stockholders who sold shares to Novartis, which include
certain of our directors and officers, made numerous representations and warranties. The
representations and warranties we made to Novartis regarding our HCV and HBV drug candidates and
our ownership of related inventions and discoveries are substantially the same as the
representations and warranties we made to Novartis in the development and commercialization
agreement. If one or more of our representations or warranties were subsequently determined not to
be true at the time we made them to Novartis, we would be in breach of this agreement. In the event
of such a breach, Novartis has the right to seek indemnification for damages suffered by Novartis
as a result of such breach, from us and, under certain circumstances, us and our stockholders who
sold shares to Novartis. The amounts for which we could be liable to Novartis could be substantial.
For additional information on such indemnification rights, see Development and Commercialization
Agreement, Risk Factors Factors Related to Our Relationship with
Novartis and Risk Factors
Factors Related to Patents and Licenses.
GlaxoSmithKline Collaboration
In February 2009, we entered into the GSK license agreement and granted GSK an exclusive
worldwide license to develop, manufacture and commercialize our NNRTI compounds, including IDX899,
for the treatment of human diseases, including HIV/AIDS. In February 2009, we also entered into a
stock purchase agreement, which we refer to as the GSK stock purchase agreement. Under this
agreement, GSK purchased approximately 2.5 million shares of our common stock at an aggregate
purchase price of $17.0 million, or a per share price of $6.87. These agreements became effective
in March 2009.
In March 2009, we received a $34.0 million payment from GSK, which consisted of a $17.0
million license fee payment under the GSK license agreement and $17.0 million under the GSK stock
purchase agreement. In 2010, we received a $6.5 million milestone payment for the achievement of a
preclinical operational milestone and a $20.0 million milestone payment for the initiation of a
phase IIb clinical study related to the development of 761. Pursuant to the GSK license agreement,
we could also potentially receive up to $390.0 million in additional milestone payments as well as
double-digit tiered royalties on worldwide product sales.
In February 2011, GSK informed us that the FDA placed 761 on clinical hold. GSK has full
responsibility for the development of 761, including regulatory interactions.
The parties have agreed that if GSK, its affiliates or its sublicensees desire to develop
IDX899 for an indication other than HIV, or if GSK intends to develop any other licensed compound
for any indication, the parties will mutually agree on a separate schedule of milestone and royalty
payments prior to the start of development.
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Under the terms of the GSK stock purchase agreement, we have agreed to cooperate in one
underwritten offering of the purchased shares, including the entry into an underwriting agreement
with customary terms, provided that such underwritten offering occurs after the first anniversary
of the closing date. The GSK stock purchase agreement may be terminated by mutual written agreement
of the parties.
GSK may terminate the license agreement, in its sole discretion, by providing us with 90 days
written notice. If either we or GSK materially breach the GSK license agreement and do not cure
such breach within 60 days, the non-breaching party may terminate the license agreement in its
entirety. Either party may also terminate the license agreement, effective immediately if the other
party files for bankruptcy,
is dissolved or has a receiver appointed for substantially all of its property. We may
terminate the license agreement if GSK, its affiliates or its sublicensees challenges the validity
or enforceability of the patents licensed to GSK under the GSK license agreement.
Under the license agreement and the stock purchase agreement, we have agreed to indemnify GSK
and its affiliates against losses suffered as a result of our breach of representations and
warranties in these agreements. We made numerous representations and warranties to GSK regarding
our NNRTI program, including IDX899, including representations regarding our ownership of
inventions and discoveries. If one or more of these representations or warranties were subsequently
determined not to be true at the time we made them to GSK, we would be in breach of these
agreements. In the event of such a breach, GSK has the right to seek indemnification from us for
damages suffered as a result of such breach. The amounts for which we may be liable to GSK could be
substantial.
As part of the transaction with GSK, Novartis waived certain rights under the development and
commercialization agreement. Specifically, subject to certain retained rights, Novartis waived its
rights to the intellectual property that covers the compounds licensed to GSK. Novartis also agreed
that the compounds licensed to GSK are deemed rejected compounds under the development and
commercialization agreement. In addition, we represented and warranted to Novartis that neither we
nor our affiliates or licensees (or their successors and assigns) would assert infringement claims
against Novartis or certain of its related entities (or their successors and assigns) if such
entities exercise limited rights under a subset of the patent rights licensed to GSK.
Pursuant to the amended and restated stockholders agreement with Novartis, Novartis also
executed a waiver and consent whereby Novartis:
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consented to the sale by us of approximately 2.5 million shares of our common stock to GSK; |
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approved our entering into the GSK license agreement; |
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waived its rights to buy a pro rata portion of the shares of our common stock issued to GSK; |
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approved our granting of registration rights to GSK and waived its rights to participate in such registration; and |
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waived, until a certain time, its rights to request that we file a registration statement on Novartis behalf or
include shares of our common stock owned by Novartis in any such registration statement filed on behalf of GSK. |
In January 2009, we amended the development and commercialization agreement to provide that
Novartis retains the exclusive option to obtain rights to drug candidates developed by us, or in
some cases licensed to us, for so long as Novartis maintains ownership of 40% of our common stock,
rather than ownership of 51% of our common stock, as was the requirement prior to the execution of
this amendment.
Additionally, in January 2009, we amended an agreement with Novartis providing that so long as
Novartis and its affiliates own at least 40% of our common stock, Novartis consent is required for
the selection and appointment of our chief financial officer. Prior to this amendment, the
ownership requirement was 51%. If in Novartis reasonable judgment our chief financial officer is
not satisfactorily performing his or her duties, we are required to terminate his or her
employment.
Lastly, as part of the transaction with GSK, GSK became a party to the cooperative research
program and exclusive license agreement we have with the Universita degli Studi di Cagliari, or the
University of Cagliari, the co-owner of certain patents and patent applications licensed by us to
GSK under the GSK license agreement. Under these arrangements, we are liable for certain payments
to the University of Cagliari if we receive license fees or milestone payments with respect to such
technology. We have made certain payments to the University of Cagliari based on the payments
received from GSK related to the development of 761. Although certain patent rights licensed to
GSK are owned solely by us and do not fall under the arrangements with the University of Cagliari,
we have entered into an arrangement whereby if it is ever deemed that any patent owned solely by us
and licensed to GSK was co-developed by anyone on the faculty of the University of Cagliari, such
co-development would fall within our existing arrangements with the University of Cagliari and no
additional payments would be due by us.
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Cooperative Laboratory Agreement
University of Cagliari
We have entered into two agreements with the University of Cagliari, the co-owner of the
patent applications covering some of our HCV and certain HIV technology. One agreement covers our
cooperative research program and the other agreement is an exclusive license under these patent
applications to develop and sell jointly created drug candidates. In May 2003 and February 2009,
Novartis and GSK, respectively, became parties to each of these agreements. The cooperative
research agreement includes provisions with respect to cost sharing, ownership and
commercialization of the technology which is discovered or obtained as part of the collaboration.
Under the terms of the cooperative research agreement, we made payments to the University of
Cagliari for use of the facilities and for supplies consumed in connection with the research
activities. This agreement terminated in December 2010.
Under the terms of the license agreement with the University of Cagliari, we have the
exclusive worldwide right to make, use and sell certain HCV and HIV technologies and the right to
sublicense any of those rights. Under the terms of the agreement, we assume the costs and
responsibility for filing, prosecuting, maintaining and defending the jointly owned patents. If we
receive license fees or milestone payments with respect to technology licensed to us by the
University of Cagliari, we must provide payments to the University of Cagliari. In addition, we
will be liable to the University of Cagliari for a fixed royalty payment on worldwide sales of
licensed drug products that derive from the specified patents. The license agreement terminates at
the expiration of all royalty payment obligations, unless terminated earlier by us, by the mutual
agreement of the parties or by a material breach of the terms of the agreement.
Research and Development Expenses
Research and development expenses for the years ended December 31, 2010, 2009 and 2008 were
$44.5 million, $41.9 million and $53.9 million, respectively, and represented 61%, 62% and 65%,
respectively, of our total operating expenses in such years.
Manufacturing
We have internally developed the capacity to synthesize compounds in quantities ranging from
milligrams to grams. Our medicinal chemists focus on small-scale synthesis that leads to the
discovery of new compounds and the analysis of structure-activity relationships for each identified
compound series. In addition, our development chemists aim to design efficient synthetic routes
suitable for process chemistry scale up to the level of one-kilogram batches of the lead molecule.
This material supports key preclinical studies, including proof-of-principle studies in animal
models, early pharmacokinetic assays, initial toxicology studies and formulation development. The
process chemistry facility we maintain in Cambridge, Massachusetts allows us to accelerate these
key studies. This facility also allows us to provide non-current good manufacturing practices
materials in multi-kilogram quantities to support early toxicological studies and the initial
development of formulations. Clinical materials are then manufactured using current good
manufacturing practices, or cGMP, by third-parties.
To reduce costs and preserve manufacturing proprietary rights, we provide third-party
manufacturers with only the required portion of the synthetic method and a sufficient quantity of
the starting or intermediate material to prepare the quantity and quality of material necessary for
the conduct of our clinical trials and related nonclinical toxicology studies. We currently rely
upon a number of third-party manufacturers for the supply of our drug candidates in bulk
quantities.
We have selected manufacturers that we believe comply with cGMP and other regulatory
standards. We have established a quality control and quality assurance program, including a set of
standard operating procedures, analytical methods and specifications, designed to ensure that our
drug candidates are manufactured in accordance with cGMP and other domestic and foreign
regulations.
Sales and Marketing
In accordance with our development and commercialization agreement with Novartis, we have the
right to co-promote or co-market with Novartis in the United States, United Kingdom, France,
Germany, Italy and Spain any products that Novartis licenses from us. If we co-promote or co-market
in the markets outside of the United States, Novartis will be primarily responsible for the
marketing, distribution and sale of products which it licenses from us.
Patents and Licenses
Our policy is to pursue patents and to otherwise protect our technology, inventions and
improvements that are important to the development of our business. We also rely upon trade secrets
that may be important to the development of our business.
Hepatitis C Patent Portfolio
Our HCV patent portfolio includes at least 22 issued U.S. patents, at least 11 pending U.S.
patent applications, at least 32 granted foreign patents and at least 24 pending foreign patent
applications. These patents are directed to treatment of HCV and other Flaviviridae infections.
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The HCV patent portfolio includes nine issued United States patents that will expire in 2021,
absent a patent term extension: U.S. Patent Nos. 6,812,219, 6,914,054, 7,105,493, 7,101,861,
7,148,206, 7,163,929, 7,169,766, 7,157,441 and 7,608,597. We co-own these nine patents with the
University of Cagliari, which has exclusively licensed its interest in the patents to us under an
agreement described under the heading Cooperative Laboratory Agreement. The HCV patent portfolio
also includes the following 10 issued U.S. patents that will expire in 2023, absent a patent term
extension: U.S. Patent Nos. 7,662,798, 7,456,155, 7,192,936, 7,384,924, 7,365,057, 7,547,704,
7,582,618, 7,608,600, 7,625,875 and 7,635,689. We co-own these 10 patents with the University of
Cagliari, the Universite Montpellier II, or the University of Montpellier, and Le Centre National
de la Recherche Scientifique, or CNRS, which have exclusively licensed their interest in the
patents to us under an agreement described in the footnotes to the financial statements to this
Annual Report on Form 10-K. In addition, the HCV patent portfolio includes U.S. Patent No.
7,138,376, which will expire in 2022, absent a patent term extension. We co-own this patent with
CNRS, which has exclusively licensed its interest in the patents to us under an agreement described
in the footnotes to the financial statements to this Annual Report on Form 10-K. The HCV patent
portfolio further includes U.S. Patent No. 7,824,851, which will expire in 2023, absent a patent
term extension. We co-own this patent with the University of Cagliari, which has exclusively
licensed its
interest in the patent to us under an agreement described under the heading Cooperative
Laboratory Agreement. The HCV patent portfolio also includes U.S. Patent No. 7,598,373, which will
expire in 2023, absent a patent term extension, and is owned exclusively by us.
Hepatitis B Patent Portfolio and Licenses
As a result of the transfer of all our development, commercialization and manufacturing rights
to Novartis relating to telbivudine, we also assigned to Novartis certain patent rights relating to
telbivudine.
Our HBV patent portfolio includes at least 10 issued U.S. patents, at least one pending U.S.
patent application, at least 49 granted foreign patents and at least 12 pending foreign patent
applications, including patents pertaining to telbivudine.
Five issued U.S. patents are directed to methods of using telbivudine for the treatment of
HBV: U.S. Patent Nos. 6,395,716, 6,569,837, 6,444,652, 6,566,344 and 7,795,238. These five U.S.
patents are co-owned by us, CNRS and the University of Montpellier. Under an agreement with these
entities described in the footnotes to the financial statements to this Annual Report on Form 10-K,
CNRS and the University of Montpellier have exclusively licensed their interest in the patents to
us. The term of U.S. Patent No. 6,569,837 has been extended and will expire in 2020 and the other
four patents will expire in 2019.
Two issued U.S. patents are directed to valtorcitabine, as well as pharmaceutical compositions
that include valtorcitabine: U.S. Patent Nos. 6,875,751 and 7,585,851, each entitled 3-Prodrugs
of 2-Deoxy-ß-L-Nucleosides. These patents will expire in 2021, absent a patent term extension.
Pursuant to the license agreement between us and the University of Alabama at Birmingham, or
UAB, we were granted an exclusive license to the rights that the University of Alabama at
Birmingham Research Foundation, or UABRF, an affiliate of UAB, Emory University and CNRS have to a
1995 U.S. patent application and progeny thereof and counterpart patent applications in Europe,
Canada, Japan and Australia that cover the use of certain synthetic nucleosides for the treatment
of HBV.
In July 2008, we entered into a settlement agreement with UAB, UABRF and Emory University
relating to our telbivudine technology. Pursuant to this settlement agreement, all contractual
disputes relating to patents covering the use of certain synthetic nucleosides for the treatment of
HBV and all litigation matters relating to patents and patent applications related to the use of
ß-L-2-deoxy-nucleosides for the treatment of HBV assigned to one or more of Idenix, CNRS and the
University of Montpellier and which cover the use of telbivudine (Tyzeka®/Sebivo®) for the
treatment of HBV have been resolved. Under the terms of the settlement agreement, we paid UABRF (on
behalf of UAB and Emory University) a $4.0 million upfront payment and will make additional
payments to UABRF equal to 20% of all royalty payments received by us from Novartis from worldwide
sales of telbivudine, subject to minimum payment obligations aggregating $11.0 million. Our payment
obligations under the settlement agreement expire on August 10, 2019. The settlement agreement was
effective on June 1, 2008 and included mutual releases of all claims and covenants not to sue among
the parties. It also included a release from a third-party scientist who had claimed to have
inventorship rights in certain Idenix/CNRS/University of Montpellier patents.
HIV Patent Portfolio
Our HIV patent portfolio includes at least five issued U.S. patents, at least three pending
U.S. applications, at least 58 granted foreign patents and at least 46 pending foreign patent
applications.
Of these five issued U.S. patents, U.S. Patent No. 6,635,636 will expire in 2019, absent a
patent term extension, and is owned exclusively by us. Absent patent term extensions, U.S. Patent
Nos. 6,545,007, 6,710,068 and 7,365,090 will expire in 2021, 2022 and 2023, respectively, and are
co-owned by us with the University of Cagliari, which has exclusively licensed its rights to us
under an agreement described under the heading Cooperative Laboratory Agreement. U.S. Patent No.
7,534,809 will expire in 2025, absent a patent term extension, and is owned exclusively by us.
Competition
Our industry is highly competitive and subject to rapid technological changes. Significant
competitive factors in our industry include product effectiveness, safety, timing and scope of
regulatory approvals, price of products, availability of supply, patent protection and sales and
marketing capabilities and resources.
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Many of the companies competing against us have substantially greater financial, technical and
other resources than we do. In addition, many of our competitors have significantly greater
experience in testing pharmaceutical and other therapeutic drug candidates as well as obtaining FDA
and other regulatory approvals of products in order to market and sell those products. Accordingly,
our competitors may be more successful than we may be in obtaining regulatory approval for products
and achieving widespread market acceptance. We also may compete with respect to manufacturing
efficiency and marketing capabilities, areas in which we have substantially less experience than
our competitors.
Tyzeka®/Sebivo®, and any future products that we successfully develop, will compete with
existing and future therapies. The key
competitive factors affecting the commercial success of our products are likely to be
efficacy, safety profile, convenience of dosing and price in comparison with available therapies.
Many organizations, including large pharmaceutical and biopharmaceutical companies as well as
academic and research organizations and government agencies, are commercializing or pursuing novel
drug therapies targeting the treatment of HCV, HBV and HIV. Companies we expect to compete with in
the HCV market include Abbott Laboratories, Boehringer Ingelheim International GmbH, F.
Hoffman-LaRoche & Co., Johnson & Johnson, Merck & Co., Inc., Pfizer, Inc., Bristol-Myers Squibb
Company, InterMune, Inc., Gilead Sciences, Inc., Vertex Pharmaceuticals, Inc., Anadys
Pharmaceuticals, Inc., Pharmasset, Inc., Achillion Pharmaceuticals, Inc., Inhibitex, Inc., Enanta
Pharmaceuticals, Inc., and Presidio Pharmaceuticals, Inc. We are aware of at least four small
molecule products that are currently marketed in the United States and elsewhere for the treatment
of HBV, excluding telbivudine, interferon alpha and pegylated interferon. The four approved
therapies are lamivudine, marketed by GlaxoSmithKline plc as Epivir-HBV®; adefovir dipoxil,
marketed by Gilead Sciences, Inc. as Hepsera®; entecavir, marketed by Bristol-Myers Squibb Company
as Baraclude®; and tenofovir disoproxil fumerate, marketed by Gilead Sciences, Inc. as Viread®.
Pegylated interferon alpha 2-a marketed by F. Hoffman-LaRoche & Co. is also approved for the
treatment of HBV. Currently, there are approximately 25 antiviral therapies approved for commercial
sale in the United States for the treatment of HIV. In addition to those companies listed above,
our competitors include smaller privately-held companies.
We believe that a significant number of clinical candidates are currently under development
and will become available in the future for the treatment of HCV, HBV and HIV. We anticipate that
we will face intense and increasing competition as new products enter the market and advanced
technologies become available. Our competitors products may be more effective, or more effectively
marketed and sold, than any product we may commercialize. Competitive products may render our
products obsolete or non-competitive before we can recover the expenses of developing and
commercializing any of our drug candidates. We are also aware that the development of a cure or new
treatment methods for the diseases we are targeting could render our products non-competitive or
obsolete.
Pharmaceutical Pricing and Reimbursement
In both domestic and foreign markets, sales of our products will depend in part upon the
availability of reimbursement from third-party payers. Third-party payers include government health
agencies, managed care providers, private health insurers and other organizations. These
third-party payers are increasingly challenging drug prices and are examining the
cost-effectiveness of medical products and services. In addition, significant uncertainty exists as
to the reimbursement status of newly approved healthcare products. We may need to conduct
pharmacoeconomic studies to demonstrate the cost-effectiveness of our products. Any drug candidates
we successfully develop may not be considered cost-effective. Adequate third-party reimbursement
may not be available to enable us to maintain price levels sufficient to realize an appropriate
return on our investment in product development. The United States and foreign governments continue
to propose and pass legislation designed to reduce the cost of healthcare. Accordingly, legislation
and regulations affecting the pricing of pharmaceutical products may change before our drug
candidates are approved for marketing. Adoption of new legislation could further limit
reimbursement for pharmaceutical products. Regulations that may be enacted are likely to affect
access to and reimbursement for pharmaceutical products. It is unclear precisely how new
regulations will impact the availability of new and emerging drug products, including any products
we may develop, alone or with a collaboration partner.
The marketability of any products we successfully develop may suffer if the government and
third-party payers fail to provide adequate coverage and reimbursement rates for such products. In
addition, an increasing emphasis on managed care in the United States has and will continue to
increase the pressure on pharmaceutical pricing.
Regulatory Matters
In October 2006, we received approval from the FDA to market Tyzeka® in the United States. In
2007, Sebivo® was approved in more than 50 countries outside the United States, including major
Asian countries and several countries included in the European Union. As previously mentioned, in
October 2007, we transferred to Novartis our worldwide regulatory, development, commercialization
and manufacturing rights and obligations related to telbivudine (Tyzeka®/Sebivo®) in exchange for
royalty payments.
In June 2008, we submitted an IND with the FDA for IDX184, our lead nucleotide polymerase
inhibitor drug candidate. In September 2009, we submitted a CTA for IDX375, our lead non-nucleoside
polymerase inhibitor drug candidate. In December 2009, we submitted a CTA for IDX320, our lead
protease inhibitor drug candidate.
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In September 2010, the FDA placed two of our HCV drug candidates, IDX184 and IDX320, on
clinical hold. The hold was imposed due to three serious adverse events of elevated liver function
tests that were detected during post drug exposure safety visits following a 14-day drug-drug
interaction study of a combination of IDX184 and IDX320 in healthy volunteers. The liver function
tests returned to normal levels in the three subjects during follow-up visits. We believe the
hepatotoxicity observed in this drug-drug interaction study was caused by IDX320 and therefore
discontinued the clinical development of this drug candidate. We filed a complete response to the
FDA and in February 2011, the full clinical hold on IDX184 was removed. The program was placed on
partial clinical hold, which allows us to initiate a phase IIb 12-week clinical trial of IDX184 in
combination with Peg-IFN/RBV with safety evaluations of the patients that will be shared with the
FDA at certain intervals in the trial. We anticipate initiating this clinical trial in the second
half of 2011.
FDA Requirements for Approval of Drug Products
The research, testing, manufacturing and marketing of drug products are extensively regulated
by numerous governmental authorities in the United States and other countries. In the United
States, drugs are subject to rigorous oversight by the FDA. The federal Food, Drug and Cosmetic Act
and other federal and state statutes and regulations govern, among other things, the research,
development, testing, manufacture, storage, record keeping, labeling, promotion, marketing and
distribution of pharmaceutical products. If we fail to comply with applicable regulatory
requirements, we may be subject to a variety of administrative or judicially imposed sanctions,
including:
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voluntary or mandatory recalls; |
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voluntary or mandatory patient and physician notification; |
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withdrawal of product approvals; |
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prohibitions against or restrictions on the marketing of our products, if approved for commercial sale; |
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fines; |
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restrictions on importation of our products; |
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injunctions; |
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debarment; |
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civil and criminal penalties; and |
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suspension of review and/or refusal to approve pending applications. |
The steps ordinarily required before a new pharmaceutical product may be marketed in the
United States include preclinical studies, animal tests and formulation studies, the submission to
the FDA of an IND, which must become effective before human clinical trials may commence in the
United States, and adequate and well-controlled human clinical trials to establish the safety and
effectiveness of the drug for each indication for which it is being tested. Satisfaction of FDA
pre-market approval requirements typically takes several years and the actual time required may
vary substantially based upon the type, complexity and novelty of the drug candidate or disease.
Government regulation may delay or prevent marketing of potential drug candidates for a
considerable period of time and impose costly procedures upon a manufacturers activities. Success
in early stage clinical trials does not assure success in later stage clinical trials. Data
obtained from clinical activities is not always conclusive and may be susceptible to varying
interpretations that could delay, limit or prevent regulatory approval. Even if a product receives
regulatory approval, later discovery of previously unknown problems with a product may result in
restrictions on the product or even complete withdrawal of the product from the market.
Preclinical studies include laboratory evaluation of product chemistry and formulation, as
well as in vitro and animal studies to assess the potential safety and efficacy of the drug
candidate. The conduct of preclinical studies and formulation of compounds for testing must comply
with federal regulations and requirements. The results of preclinical studies are submitted to the
FDA, as part of the IND to justify the administration of the drug candidate to human subjects in
the proposed clinical trial.
A 30-day waiting period after the filing of each IND is required prior to the commencement of
clinical testing in humans. If the FDA has not commented on or questioned the IND within this
30-day period, the proposed clinical trial may begin. If the FDA has comments or questions, the
questions must be answered to the satisfaction of the FDA before initial clinical testing can
begin.
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After the commencement of clinical trials, the FDA may, at any time, impose a clinical hold on
ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot commence or
recommence without FDA authorization and then only under terms authorized by the FDA. Additionally,
if a clinical hold is imposed on an ongoing clinical trial, further administration of the
investigational agent to patients would not be permitted unless specifically allowed by the FDA. In
some instances, the IND process can result in substantial delay and expense. Clinical trials
involve the administration of the drug candidate to healthy volunteers or patients under the
supervision of a qualified principal investigator. Clinical trials must be conducted in compliance
with federal regulations and requirements, under protocols detailing the objectives of the clinical
trial, the parameters to be used in monitoring safety and the effectiveness criteria to be
evaluated. Each protocol must be submitted to the FDA as part of the IND. The clinical trial
protocol and informed consent information for patients to be enrolled in the clinical trial must
also be approved by the institutional review board at each institution where the clinical trials
will be conducted.
Clinical trials to support new drug applications, or NDAs, for marketing approval are
typically conducted in three sequential phases, but the phases may overlap. In phase I, the initial
introduction of a drug candidate into healthy human subjects, a drug candidate is tested to
assess metabolism, pharmacokinetics and pharmacological activity and safety, including side
effects associated with increasing doses. Phase II usually involves clinical trials in a limited
subset of the intended patient population to determine dosage tolerance and optimum dosage,
identify possible adverse effects and safety risks and provide preliminary support for the efficacy
of the drug candidate in the indication being studied. If a drug candidate demonstrates promising
preliminary safety and efficacy profiles in phase II evaluations, phase III clinical trials are
undertaken to further evaluate clinical efficacy and to further test for safety within an expanded
patient population at geographically dispersed clinical trial sites. There can be no assurance that
phase I, phase II or phase III testing of our drug candidates will be completed successfully within
any specified time period, if at all.
After completion of the required clinical testing, generally an NDA is prepared and submitted
to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the
United States. The NDA must include, among other things, the results of extensive clinical and
preclinical studies and the compilation of data relating to the products chemistry, pharmacology,
manufacture, safety and effectiveness. The cost of an NDA is substantial, both in terms of studies
required to generate and compile the requisite data, as well as the mandatory user fees submitted
with the application.
The FDA has 60 days from its receipt of the NDA to determine whether the application will be
accepted for filing based on the agencys threshold determination that the NDA is sufficiently
complete to permit substantive review. Once the submission is accepted for filing, the FDA may
designate the submission for priority review. Priority review is granted to drug candidates that
demonstrate a potential for significant improvement to approved products in terms of safety or
efficacy in the treatment, diagnosis or prevention of serious or life-threatening conditions. The
FDAs decision to grant priority review is driven solely by the data submitted and cannot be
assured in advance. Under the Prescription Drug User Fee Act, drug candidates that are given a
priority review designation have a six month FDA review timeline.
After a submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under
federal law, the FDA has 180 days in which to review the application and respond to the applicant.
The review timeline is often significantly extended by FDA requests for additional information or
clarification regarding information already provided in the submission. The FDA may also refer the
application to an appropriate advisory committee, typically a panel that includes clinicians,
statisticians and other experts for review, evaluation and a recommendation as to whether the
application should be approved. The FDA is not bound by the recommendation of an advisory
committee.
If FDA evaluations of the NDA and the manufacturing facilities are favorable, the FDA may
issue an approval letter. If the NDA will not be approved by the FDA in its current form, the FDA
will issue a complete response letter describing the NDA deficiencies and the required actions
needed for approval, if appropriate. When and if those conditions have been met to the FDAs
satisfaction, the FDA may then issue an approval letter. The approval letter authorizes commercial
marketing of the drug for specific indications. As a condition of the NDA approval, the FDA may
require post-marketing testing and surveillance to monitor the drugs safety or efficacy, or impose
other conditions. Once granted, product approvals may be withdrawn if compliance with regulatory
standards is not maintained or problems occur following initial marketing.
Once the NDA is approved, a product will be subject to certain post-approval requirements,
including requirements for adverse event reporting and submission of periodic reports and/or
supplemental new drug applications for approval of changes to the originally approved prescribing
information, product formulation, and manufacturing and testing requirements. Following approval,
drug products are required to be manufactured and tested for compliance with the NDA and/or
compendial specifications prior to release for commercial distribution. The manufacture and testing
must be performed in approved manufacturing and testing sites complying with cGMP requirements and
subject to FDA inspection authority.
Approved drug products must be promoted in a manner which is consistent with their terms and
conditions of approval. In addition, the FDA requires substantiation of any claims of superiority
of one product over another including, in many cases, requirements that such claims be proven by
adequate and well controlled head-to-head clinical trials. To the extent that market acceptance of
our drug candidates may depend on their superiority over existing therapies, any restriction on our
ability to advertise or otherwise promote claims of superiority, or requirements to conduct
additional expensive clinical trials to provide proof of such claims, could negatively affect the
sales of our products and/or our expenses.
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From time to time, legislation is drafted and introduced that could significantly change the
statutory provisions governing the approval, manufacturing and marketing of drug products. In
addition, FDA regulations and guidance are often revised or reinterpreted by the FDA or the courts
in ways that may significantly affect our business and our drug candidates. It is impossible to
predict whether legislative changes will be enacted, or FDA regulations, guidance or
interpretations will be changed, or what the impact of such changes, if any, may be.
If the FDAs evaluation of the NDA submission or manufacturing facilities is not favorable,
the FDA may decide that the application does not satisfy the regulatory criteria for approval.
Foreign Regulation of Drug Product Approval in Europe
In the European Union, investigational products are subject to extensive regulatory
requirements. Prior to the initiation of clinical trials with investigational drug products,
sponsor companies must file CTAs in the individual European Union countries in which subjects or
patients will be enrolled. CTAs are similar to United States INDs and provide the local health
authority and ethics committee with the study protocol, informed consent form, summaries of the
manufacturing process as well as the preclinical animal toxicology results. Approval for the study
can take from one to three months depending on the country, health authority and ethics committee.
As in the United States, the marketing of medicinal products is subject to the granting of
marketing authorizations by relevant regulatory agencies. The granting of these marketing
authorizations can involve additional testing as compared to the FDA requirements. Also, the time
required may differ from that required for FDA approval. In the European Union, approval of new
pharmaceutical products can be granted either through a mutual recognition procedure and
decentralized approval or through a centralized procedure. Our drug candidates fall under the
centralized procedure category.
Centralized Procedure
The centralized procedure is currently mandatory for products developed by means of a
biotechnological process and medicinal products which contain new active substances and for which
the indication is treatment of AIDS, cancer, neurodegenerative disorder, diabetes, autoimmune
diseases and other immune dysfunctions and viral diseases.
Under the centralized procedure, an application is submitted to the European Medicines Agency,
or EMEA. Two European Union member states are appointed to conduct an initial evaluation of each
application, the so-called rapporteur and co-rapporteur countries. The regulatory authorities in
both the rapporteur and co-rapporteur countries each prepare an assessment report. These reports
become the basis of a scientific opinion of the Committee for Medicinal Products for Human Use. If
this opinion is favorable, it is sent to the European Commission which drafts a decision. After
consulting with the member states, the European Commission adopts a decision and grants a marketing
authorization which is valid throughout the European Union and confers the same rights and
obligations in each of the member states as a marketing authorization granted by that member state.
Several other European countries outside the European Union, such as Norway and Iceland, accept
European Union review and approval as a basis for their own national approval.
Foreign Regulation of Drug Product Approval in Asia
Until recently, submissions to regulatory authorities in Asia for marketing authorization have
been primarily based on using prior approvals in either the United States or countries in the
European Union as well as small, locally conducted studies. Recently an increasing number of
companies are conducting phase III clinical trials in several major Asian countries such as Japan,
China, Taiwan and South Korea. To conduct clinical trials in these regions, local clinical trial
applications, equivalent to INDs, must be filed in the country. Upon completion of all clinical
trials, marketing applications, similar to the United States NDA, may be submitted to and approved
by the appropriate regulatory authorities prior to commercialization.
Marketing Applications Format
As part of the International Conference on Harmonization, or ICH, standardization initiatives
spearheaded by the United States, European Union and Japan, future marketing applications in these
regions will be submitted as a core global dossier known as the Common Technical Document, or CTD.
While the FDA has not mandated that submissions be made in the CTD format, it has indicated that
this is its preferable submission format. In the European Union and Japan, the CTD is the required
submission format. Electronic CTDs are currently being used and are the manner of submission now
preferred by the regulatory agencies requiring and recommending the CTD format. Non-ICH regions
such as Eastern and Central Europe, Latin America and China have indicated that the CTD will be an
acceptable submission format.
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Hazardous Materials
Our research and development processes involve the controlled use of numerous hazardous
materials, chemicals and radioactive materials and produce waste products. We are subject to
federal, state and local laws and regulations governing the use, manufacture, storage, handling and
disposing of hazardous materials and waste products, including certain regulations promulgated by
the U.S. Environmental Protection Agency, or EPA. The EPA regulations to which we are subject
require that we register with the EPA as a generator of hazardous waste. We do not expect the cost
of complying with these laws and regulations to be material. While we maintain insurance, it is
possible that costs for which we may become liable as a result of any environmental liability or
toxic tort claims that may be asserted against us in connection with our use or disposal of
hazardous materials, chemicals and radioactive materials, may exceed or otherwise be excluded from
such insurance coverage. Such amounts could be substantial.
Employees
As of December 31, 2010, we had 109 full time employees. We had 85 employees engaged in
research, development and manufacturing functions, 33 of whom hold Ph.D. degrees. We also had 24
employees engaged in administration and finance activities.
Available Information
Our website address is www.idenix.com. We make available, free of charge, on or through our
website our annual reports on Form 10-K, quarterly reports on Form 10-Q, periodic reports on Form
8-K and all amendments to those reports as soon as reasonably practicable after such material is
electronically filed with or furnished to the Securities and Exchange Commission, or SEC. We are
not, however, including the information contained on our website, or information that may be
accessed through links on our website, as part of, or incorporating it by reference into, this
Annual Report on Form 10-K. In addition, copies of our reports filed electronically with the SEC
may be accessed on the SECs website at www.sec.gov. The public may also read and copy any
materials filed with the SEC at the SECs Public Reference Room at 100 F Street, NE, Washington, DC
20549. Information on the operation of the Public Reference Room may be obtained by calling the SEC
at 1-800-SEC-0330. We intend to disclose on our website any amendments to, or waivers from, our
code of business conduct and ethics that are required to be disclosed pursuant to rules and
regulations promulgated by the SEC.
Corporate Information
We are a Delaware corporation. Our principal offices are located at 60 Hampshire Street,
Cambridge, Massachusetts 02139. The telephone number of our principal executive offices is
617-995-9800. Idenix is one of our registered trademarks or service marks. All other trademarks,
service marks or tradenames referenced in this Annual Report on Form 10-K are the property of their
respective owners.
Our business faces many risks. The risks described below may not be the only risks we face.
Additional risks we do not yet know of or we currently believe are immaterial may also impair our
business operations. If any of the events or circumstances described in the following risks
actually occurs, our business, financial condition or results of operations could suffer and the
trading price of our common stock could decline. The following risks should be considered, together
with all of the other information in our Annual Report on Form 10-K for the year ended December 31,
2010, before deciding to invest in our securities.
Factors Related to Our Business
The FDA placed one of our drug candidates, IDX184 on partial clinical hold and our business may be
adversely affected if we are not able to continue to pursue development of IDX184 or if we are
significantly delayed in developing IDX184.
Our primary research and development focus is the treatment of patients with HCV. Our most
advanced compound under development is IDX184, a nucleotide polymerase inhibitor. Our other drug
candidates for the treatment of HCV are in preclinical and early clinical stages of development. In
the third quarter of 2010, we completed a dose-ranging phase IIa trial evaluating IDX184 in
combination with pegylated interferon and ribavirin. Following a 14-day drug-drug interaction study
of a combination of IDX184 and IDX320 in healthy volunteers. in September 2010, the FDA placed
IDX184 and IDX320 on clinical hold due to three serious adverse events of elevated liver function
tests that were detected during post drug exposure safety visits. We believe the hepatotoxicity
observed in this drug-drug interaction study was caused by IDX320 and therefore discontinued the
clinical development of this drug candidate. In February 2011, the full clinical hold on IDX184 was
removed. The program was placed on partial clinical hold, which allows us to initiate a phase IIb
12-week clinical trial of IDX184 in combination with pegylated interferon and ribavirin with safety
evaluations of the patients that will be shared with the FDA at certain intervals in the trial. We
anticipate initiating this clinical trial in the second half of 2011. If we are not able to
continue development of IDX184, or if our progress in development of IDX184 is slowed
significantly, our business may be adversely affected.
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Our product candidates may exhibit undesirable side effects when used alone or in combination with
other approved pharmaceutical products or investigational agents, which may delay or preclude their
further development or regulatory approval, or limit their use if approved.
Throughout the drug development process, we must continually demonstrate the safety and
tolerability of our product candidates in order to obtain regulatory approval to advance their
clinical development or to market them. Even if our product candidates demonstrate biologic
activity and clinical efficacy, any unacceptable adverse side effects or toxicities, when
administered alone or in the presence of other pharmaceutical products or investigational agents,
which can arise at any stage of development, may outweigh their potential benefit. For
instance, in September 2010, two of our drug candidates, IDX184 and IDX320,
were placed on clinical hold by the FDA due to three serious adverse events of elevated
liver function tests that were detected during post drug exposure safety visits following a 14-day
drug-drug interaction study of a combination of IDX184 and IDX320 in healthy volunteers. In
future preclinical studies and clinical trials our product candidates may demonstrate unacceptable
safety profiles or unacceptable drug-drug interactions, which could result in the delay or
termination of their development, prevent regulatory approval or limit their market acceptance if
they are ultimately approved.
We have a limited operating history and have incurred a cumulative loss since inception. If we do
not generate significant revenues, we will not be profitable.
We have incurred significant losses each year since our inception in May 1998. Telbivudine
(Tyzeka®/Sebivo®), our only product to reach commercialization, is marketed
by Novartis, and we receive royalty payments associated with sales of this product. We have
generated limited revenue from the sales of Tyzeka®/Sebivo® to date. Due to
our limited Tyzeka®/Sebivo® sales history, there is risk in determining the
potential future revenue associated with potential sales of this product or any other product that
reaches commercialization. We will not be
able to generate additional revenues from other product sales until we successfully complete
clinical development and receive regulatory approval for one of our other drug candidates, and we
or a collaboration partner successfully introduce such product commercially. We expect to incur
annual operating losses over the next several years as we continue to expand our drug discovery and
development efforts. We also expect that the net loss we will incur will fluctuate from quarter to
quarter and such fluctuations may be substantial. To generate product revenue, regulatory approval
for products we successfully develop must be obtained and we and/or one of our existing or future
collaboration partners must effectively manufacture, market and sell such products. Even if we
successfully commercialize drug candidates that receive regulatory approval, we may not be able to
realize revenues at a level that would allow us to achieve or sustain profitability. Accordingly,
we may never generate significant revenue and, even if we do generate significant revenue, we may
never achieve profitability.
We will need additional capital to fund our operations, including the development, manufacture and
potential commercialization of our drug candidates. If we do not have or cannot raise additional
capital when needed, we will be unable to develop and ultimately commercialize our drug candidates
successfully.
Our cash and cash equivalents balance was $46.1 million at December 31, 2010. We believe that
in addition to this balance the anticipated royalty payments associated with product sales of
Tyzeka®/Sebivo® and our ability and intent to manage expenditures will be
sufficient to satisfy our cash needs for at least the next 12 months from December 31, 2010. Our
drug development programs and the potential commercialization of our drug candidates will require
substantial cash to fund expenses that we will incur in connection with preclinical studies and
clinical trials, regulatory review and future manufacturing and sales and marketing efforts.
Our need for additional funding will depend in part on whether:
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with respect to 761, GSK is able to continue clinical development of this drug candidate, following the clinical hold imposed by the
FDA in February 2011, such that we receive certain clinical development milestone payments within the next 24 months; |
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with respect to our other drug candidates, Novartis exercises its option to license any such drug candidates, and we receive related
license fees, milestone payments and development expense reimbursement payments from Novartis; with respect to any of our drug
candidates not licensed by Novartis, we receive related license fees, milestone payments and development expense reimbursement
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with respect to Tyzeka®/Sebivo®, whether the level of royalty payments received from Novartis is significant; and |
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the terms of a development and commercialization agreement, if any, that we enter into with respect to our drug candidate, IDX184, for
the treatment of HCV. We are currently seeking a partner who will assist in the future development and commercialization of IDX184.
Our efforts to find a partner may be slowed because the FDA has placed this drug candidate on partial clinical hold as a result of
serious adverse events related to elevated liver function tests that were detected during post drug exposure safety visits following a
14-day drug-drug interaction study of a combination of IDX184 and IDX320 in healthy volunteers. |
In addition, although Novartis has agreed to pay for certain development expenses incurred
under development plans it approves for products and drug candidates that it has licensed from us,
Novartis has the right to terminate its license and the related funding obligations with respect to
any such product or drug candidate by providing us with six months written notice. Furthermore, GSK
has the right to terminate the GSK license agreement by providing us with 90 days written notice.
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Our future capital needs will also depend generally on many other factors, including:
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the amount of revenue that we may be able to realize from commercialization and sale of drug candidates, if any,
which are approved by regulatory authorities; |
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the scope and results of our preclinical studies and clinical trials; |
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the progress of our current preclinical and clinical development programs for HCV; |
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the cost of obtaining, maintaining and defending patents on our drug candidates and our processes; |
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the cost, timing and outcome of regulatory reviews; |
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any costs associated with changes in rules and regulations promulgated by the FDA related to the drug development
process and/or clinical trials; |
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the commercial potential of our drug candidates; |
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the rate of technological advances in our markets; |
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the cost of acquiring or in-licensing new discovery compounds, technologies, drug candidates or other business assets; |
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the magnitude of our general and administrative expenses; |
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any costs related to litigation in which we may be involved or related to any claims made against us; |
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any costs we may incur under current and future licensing arrangements; and |
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the costs of commercializing and launching other products, if any, which are successfully developed and approved for
commercial sale by regulatory authorities. |
We expect that we will incur significant costs to complete the clinical trials and other
studies required to enable us to submit regulatory applications with the FDA and/or the EMEA for
our drug candidates as we continue development of each of our drug candidates. The time and cost to
complete clinical development of our drug candidates may vary as a result of a number of factors.
We may seek additional capital through a combination of public and private equity offerings,
debt financings and collaborative, strategic alliance and licensing arrangements. Such additional
financing may not be available when we need it or may not be available on terms that are favorable
to us. Moreover, any financing requiring the issuance of additional shares of capital stock must
first be approved by Novartis so long as Novartis continues to own at least 19.4% of our voting
stock. In May 2009, we received approval from Novartis to issue additional shares pursuant to a
financing under our existing shelf registration so long as the issuance of additional shares did
not reduce Novartis interest in Idenix below 43%. As of February 15, 2011, Novartis owned
approximately 43% of our outstanding common stock.
If we raise additional capital through the sale of our common stock, existing stockholders,
other than Novartis, which has the right to maintain a certain level of ownership, will experience
dilution of their current level of ownership of our common stock and the terms of the financing may
adversely affect the holdings or rights of our stockholders. If we are unable to obtain adequate
financing on a timely basis, we could be required to delay, reduce or eliminate one or more of our
drug development programs or to enter into new collaborative, strategic alliances or licensing
arrangements that may not be favorable to us. More generally, if we are unable to obtain adequate
funding, we may be required to scale back, suspend or terminate our business operations.
Our research and development efforts may not result in additional drug candidates being discovered
on anticipated timelines, which could limit our ability to generate revenues.
Some of our research and development programs are at preclinical stages. Additional drug
candidates that we may develop or acquire will require significant research, development,
preclinical studies and clinical trials, regulatory approval and commitment of resources before any
commercialization may occur. We cannot predict whether our research will lead to the discovery of
any additional drug candidates that could generate revenues for us.
Our failure to successfully acquire or develop and market additional drug candidates or approved
drugs would impair our ability to grow.
As part of our strategy, we intend to establish a franchise in the HCV market by developing
multiple drug candidates for this therapeutic indication. The success of this strategy depends upon
the development and commercialization of additional drug candidates that we successfully discover,
license or otherwise acquire. In September 2010, the FDA placed two of our HCV drug candidates,
IDX184 and IDX320, on clinical hold. The hold was imposed due to three serious adverse events of
elevated liver function tests that were detected during post drug exposure safety visits following
a 14-day drug-drug interaction study of a combination of IDX184 and IDX320 in healthy volunteers.
We believe the hepatotoxicity observed in this drug-drug interaction study was caused by IDX320 and
therefore discontinued the clinical development of this drug candidate. In February 2011, the full
clinical hold on IDX184 was removed by the FDA and the program was placed on partial clinical hold.
21
Drug candidates we discover, license or acquire will require additional and likely substantial
development, including extensive clinical testing and approval by the FDA and applicable foreign
regulatory authorities. All drug candidates are prone to the risks of failure which are inherent in
pharmaceutical drug development, including the possibility that the drug candidate will not be
shown to be sufficiently safe and effective for approval by regulatory authorities.
Proposing, negotiating and implementing acquisition or in-license of drug candidates may be a
lengthy and complex process. Other companies, including those with substantially greater financial,
marketing and sales resources, may compete with us for the acquisition of drug candidates. We may
not be able to acquire the rights to additional drug candidates on terms that we find acceptable.
Our investments are subject to general credit, liquidity, market and interest rate risks, which may
be exacerbated by the volatility in the United States credit markets.
As of December 31, 2010, our cash and cash equivalents were invested in government agency and
treasury money market instruments.
Our investment policy seeks to manage these assets to achieve our goals of preserving
principal and maintaining adequate liquidity. The distress in the financial markets over the past
two years has caused previously held investments to become less liquid and decline in value. To
mitigate the risk presented by holding illiquid securities, beginning in 2008, we shifted our
investments to instruments that carry less exposure to market volatility and liquidity pressures.
Should our investments cease paying or reduce the amount of interest paid to us, our interest
income would suffer. In addition, general credit, liquidity, market and interest risks associated
with our investment portfolio may have an adverse effect on our financial condition.
The commercial markets which we intend to enter are subject to intense competition. If we are
unable to compete effectively, our drug candidates may be rendered noncompetitive or obsolete.
We are engaged in segments of the pharmaceutical industry that are highly competitive and
rapidly changing. Many large pharmaceutical and biotechnology companies, academic institutions,
governmental agencies and other public and private research organizations are commercializing or
pursuing the development of products that target viral diseases, including the same diseases we are
targeting.
We face intense competition from existing products and we expect to face increasing
competition as new products enter the market and advanced technologies become available. For the
treatment of HBV, we are aware of six other drug products, specifically, lamivudine, entecavir,
adefovir dipivoxil, tenofovir, pegylated interferon and interferon alpha, which are approved by the
FDA and commercially available in the United States or in foreign jurisdictions. Five of these
products have preceded Tyzeka®/Sebivo® into the marketplace and have gained
acceptance with physicians and patients. For HCV, the current treatment is pegylated interferon in
combination with ribavirin, a nucleoside analog. Two drug products, telaprevir and boceprevir, have
been submitted for NDAs and could be approved for the treatment of HCV in combination with
pegylated interferon and ribavirin in the coming year. Currently, there are approximately 25
antiviral therapies approved for commercial sale in the United States for the treatment of HIV.
We believe that a significant number of drug candidates that are currently under development
may become available in the future for the treatment of HBV, HCV and HIV. Our competitors products
may be more effective, have fewer side effects, have lower costs or be better marketed and sold
than any of our products. Additionally, products that our competitors successfully develop for the
treatment of HCV and HIV may be marketed prior to any HCV or HIV product we or our collaboration
partners successfully develop. Many of our competitors have:
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significantly greater financial, technical and human resources than we have and may be better
equipped to discover, develop, manufacture and commercialize products; |
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more extensive experience in conducting preclinical studies and clinical trials, obtaining
regulatory approvals and manufacturing and marketing pharmaceutical products; |
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products that have been approved or drug candidates that are in late-stage development; and |
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collaborative arrangements in our target markets with leading companies and research institutions. |
Novartis and GSK have the right to market and sell products that compete with the drug
candidates and products that we license to them and any competition by Novartis or GSK could have a
material adverse effect on our business.
Competitive products may render our products obsolete or noncompetitive before we can recover
the expenses of developing and commercializing our drug candidates. Furthermore, the development of
new treatment methods and/or the widespread adoption or increased utilization of vaccines for the
diseases we are targeting could render our drug candidates noncompetitive, obsolete or
uneconomical.
22
With respect to Tyzeka®/Sebivo® and other products, if any, we may
successfully develop and obtain approval to commercialize, we will face competition based on the
safety and effectiveness of our products, the timing and scope of regulatory approvals, the
availability and cost of supply, marketing and sales capabilities, reimbursement coverage, price,
patent position and other factors. Our competitors may develop or commercialize more effective or
more affordable products or obtain more effective patent protection than we do. Accordingly, our
competitors may commercialize products more rapidly or effectively than we do, which could
adversely affect our competitive position and business.
Biotechnology and related pharmaceutical technologies have undergone and continue to be
subject to rapid and significant change. Our future will depend in large part on our ability to
maintain a competitive position with respect to these technologies.
If we are not able to attract and retain key management and scientific personnel and advisors, we
may not successfully develop our drug candidates or achieve our other business objectives.
The growth of our business and our success depends in large part on our ability to attract and
retain key management and research and development personnel. Our key personnel include our senior
officers, many of whom have very specialized scientific, medical or operational knowledge. The loss
of the service of any of the key members of our senior management team may significantly delay or
prevent our
discovery of additional drug candidates, the development of our drug candidates and
achievement of our other business objectives. Our ability to attract and retain qualified
personnel, consultants and advisors is critical to our success.
We face intense competition for qualified individuals from numerous pharmaceutical and
biotechnology companies, academic institutions, governmental entities and other research
institutions. We may be unable to attract and retain these individuals and our failure to do so
would have an adverse effect on our business.
Our business has a substantial risk of product liability claims. If we are unable to obtain or
maintain appropriate levels of insurance, a product liability claim against us could adversely
affect our business.
Our business exposes us to significant potential product liability risks that are inherent in
the development, manufacturing and marketing of human therapeutic products. Product liability
claims could result in a recall of products or a change in the therapeutic indications for which
such products may be used. In addition, product liability claims may distract our management and
key personnel from our core business, require us to spend significant time and money in litigation
or to pay significant damages, which could prevent or interfere with commercialization efforts and
could adversely affect our business. Claims of this nature would also adversely affect our
reputation, which could damage our position in the marketplace.
For Tyzeka®/Sebivo®, product liability claims could be made against us
based on the use of our product prior to October 1, 2007, at which time we transferred to Novartis
our worldwide development, commercialization and manufacturing rights and obligations related to
Tyzeka®/Sebivo® in exchange for royalty payments equal to a percentage of net
sales. For Tyzeka®/Sebivo® and our drug candidates, product liability claims
could be made against us based on the use of our drug candidates in clinical trials. We have
obtained product liability insurance for Tyzeka®/Sebivo® and maintain
clinical trial insurance for our drug candidates in development. Such insurance may not provide
adequate coverage against potential liabilities. In addition, clinical trial and product liability
insurance is becoming increasingly expensive. As a result, we may be unable to maintain or increase
current amounts of product liability and clinical trial insurance coverage, obtain product
liability insurance for other products, if any, that we seek to commercialize, obtain additional
clinical trial insurance or obtain sufficient insurance at a reasonable cost. If we are unable to
obtain or maintain sufficient insurance coverage on reasonable terms or to otherwise protect
against potential product liability claims, we may be unable to commercialize our products or
conduct the clinical trials necessary to develop our drug candidates. A successful product
liability claim brought against us in excess of our insurance coverage may require us to pay
substantial amounts in damages. This could adversely affect our cash position and results of
operations.
Our insurance policies are expensive and protect us only from some business risks, which will leave
us exposed to significant, uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. We
currently maintain general liability, property, workers compensation, products liability,
directors and officers and employment practices insurance policies. We do not know, however, if
we will be able to maintain existing insurance with adequate levels of coverage. Any significant
uninsured liability may require us to pay substantial amounts, which would adversely affect our
cash position and results of operations.
If the estimates we make, and the assumptions on which we rely, in preparing our financial
statements prove inaccurate, our actual results may vary from those reflected in our projections
and accruals.
Our financial statements have been prepared in accordance with generally accepted accounting
principles in the United States of America. The preparation of these financial statements requires
us to make estimates and judgments that affect the reported amounts of our assets, liabilities,
revenues and expenses, the amounts of charges accrued by us and related disclosures of contingent
assets and liabilities. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable under the circumstances. There can be no assurance,
however, that our estimates, or the assumptions underlying them, will not change.
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One of these estimates is our estimate of the development period over which we amortize
non-refundable payments from Novartis, which we review on a quarterly basis. In the second quarter
of 2010, we adjusted the period over which we amortize the deferred payments to be through May 2021
based on current judgments related to the product development timeline of our licensed drug
candidates. When the estimated development period changes, we adjust periodic revenue that is being
recognized and record the remaining unrecognized non-refundable payments over the remaining
development period during which our performance obligations are completed. Significant judgments
and estimates are involved in determining the estimated development period and different
assumptions could yield materially different financial results. This, in turn, could adversely
affect our stock price.
If we fail to design and maintain an effective system of internal controls, we may not be able to
accurately report our financial results or prevent fraud. As a result, current and potential
stockholders could lose confidence in our financial reporting, which could harm our business and
the trading price of our common stock.
As directed by Section 404 of the Sarbanes-Oxley Act of 2002, the SEC adopted rules requiring
public companies to include a report in Annual Reports on Form 10-K that contains an assessment by
management of the effectiveness of the companys internal controls over financial reporting. In
addition, the companys registered independent public accounting firm must attest to the
effectiveness of our internal
controls over financial reporting.
We have completed an assessment and will continue to review in the future our internal
controls over financial reporting in an effort to ensure compliance with the Section 404
requirements. The manner by which companies implement, maintain and enhance these requirements
including internal control reforms, if any, to comply with Section 404, and how registered
independent public accounting firms apply these requirements and test companies internal controls,
is subject to change and will evolve over time. As a result, notwithstanding our efforts, it is
possible that either our management or our registered independent public accounting firm may in the
future determine that our internal controls over financial reporting are not effective.
A determination that our internal controls over financial reporting are ineffective could
result in an adverse reaction in the financial marketplace due to a loss of investor confidence in
the reliability of our financial statements, which ultimately could negatively impact the market
price of our stock, increase the volatility of our stock price and adversely affect our ability to
raise additional funding.
Our business is subject to international economic, political and other risks that could negatively
affect our results of operations or financial position.
Our business is subject to risks associated with doing business internationally, including:
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changes in a specific countrys or regions political or economic conditions, including Western Europe, in particular; |
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potential negative consequences from changes in tax laws affecting our ability to repatriate profits; |
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difficulty in staffing and managing widespread operations; |
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unfavorable labor regulations applicable to our European or other international operations; |
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changes in foreign currency exchange rates; and |
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the need to ensure compliance with the numerous regulatory and legal requirements applicable to our business in each
of these jurisdictions and to maintain an effective compliance program to ensure compliance. |
Our operating results are impacted by the health of the North American, European and Asian
economies. Our business and financial performance may be adversely affected by current and future
economic conditions that cause a decline in business and consumer spending, including a reduction
in the availability of credit, rising interest rates, financial market volatility and recession.
We may be required to relocate one of our principal research facilities, which could interrupt our
business activities and result in significant expense.
We have been involved in a dispute with the City of Cambridge, Massachusetts and its License
Commission pertaining to the level of noise emitted from certain rooftop equipment at our research
facility located at 60 Hampshire Street in Cambridge. The License Commission has claimed that we
are in violation of the local noise ordinance pertaining to sound emissions, based on a complaint
from neighbors living adjacent to the property. We have contested this alleged violation before the
License Commission, as well as the Middlesex County, Massachusetts, Superior Court. In July 2010,
the License Commission granted us a special variance from the requirements of the local noise
ordinance for a period of one-year, effective as of July 1, 2010. We may, however, be required to
cease certain activities at the building if: a) the noise emitted from certain rooftop equipment at
our research facility exceeds the levels permitted by the special variance; b) the parties are
unable to resolve this matter through negotiations and remedial action; or c) our legal challenge
to the position of the City of Cambridge and the License Commission is unsuccessful. In any such
event, we could be required to relocate to another facility which could interrupt some of our
business activities and could be time consuming and costly.
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Factors Related to Development, Clinical Testing and Regulatory Approval of Our Drug Candidates
All of our drug candidates are in development. Our drug candidates remain subject to clinical
testing and regulatory approval. If we are unable to develop our drug candidates, we will not be
successful.
To date, we have limited experience marketing, distributing and selling any products. The
success of our business depends primarily upon Novartis ability to commercialize
Tyzeka®/Sebivo®, GSKs ability to successfully develop and commercialize our
NNRTI compounds, including IDX899, and our ability, or that of any future collaboration partner, to
successfully commercialize other products we may successfully develop. We received approval from
the FDA in the fourth quarter of 2006 to market and sell Tyzeka® for the treatment of
HBV in the United States. In April 2007, Sebivo® was approved in the European Union for
the treatment of patients with HBV. Effective October 1, 2007, we transferred to Novartis our
worldwide development, commercialization and manufacturing rights and obligations related to
telbivudine (Tyzeka®/Sebivo®) in exchange for royalty payments equal to a
percentage of net sales. The royalty percentage varies based on the specified territory and the
aggregate dollar amount of net sales. In February 2009, we entered into the GSK license agreement
whereby
GSK is solely responsible for the worldwide development, manufacture and commercialization of
our NNRTI compounds, including IDX899, now known as 761, for the treatment of human diseases,
including HIV/AIDS. In February 2011, GSK informed us that the FDA placed 761 on clinical hold.
GSK has full responsibility for the development of 761, including any regulatory interactions. If
GSK is unable to successfully develop 761 or any other compound licensed to it, we will not
receive additional milestone or royalty payments from GSK.
Our other drug candidates are in various earlier stages of development. All of our drug
candidates require regulatory review and approval prior to commercialization. Approval by
regulatory authorities requires, among other things, that our drug candidates satisfy rigorous
standards of safety, including efficacy and assessments of the toxicity and carcinogenicity of the
drug candidates we are developing. To satisfy these standards, we must engage in expensive and
lengthy testing. Notwithstanding the efforts to satisfy these regulatory standards, our drug
candidates may not:
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offer therapeutic or other improvements over existing drugs; |
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be proven safe and effective in clinical trials; |
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meet applicable regulatory standards; |
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be capable of being produced in commercial quantities at acceptable costs; or |
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be successfully commercialized. |
Commercial availability of our drug candidates is dependent upon successful clinical
development and receipt of requisite regulatory approvals. Clinical data often are susceptible to
varying interpretations. Many companies that have believed that their drug candidates performed
satisfactorily in clinical trials in terms of both safety and efficacy have nonetheless failed to
obtain approval for such drug candidates. Furthermore, the FDA and other regulatory authorities may
request additional information including data from additional clinical trials, which may
significantly delay any approval and these regulatory agencies ultimately may not grant marketing
approval for any of our drug candidates. For example, in September 2010, the FDA placed on clinical
hold two of our HCV drug candidates, IDX184 and IDX320. The hold was imposed due to three serious
adverse events of elevated liver function tests that were detected during post drug exposure safety
visits following a 14-day drug-drug interaction study of a combination of IDX184 and IDX320 in
healthy volunteers. We believe the hepatotoxicity observed in this drug-drug interaction study was
caused by IDX320 and therefore discontinued the clinical development of this drug candidate. In
February 2011, the full clinical hold on IDX184 was removed. The program was placed on partial
clinical hold, which allows us to initiate a phase IIb 12-week clinical trial of IDX184 in
combination with Peg-IFN/RBV with safety evaluations of the patients that will be shared with the
FDA at certain intervals in the trial.
If our clinical trials are not successful, we will not obtain regulatory approval for the
commercial sale of our drug candidates.
To obtain regulatory approval for the commercial sale of our drug candidates, we will be
required to demonstrate through preclinical studies and clinical trials that our drug candidates
are safe and effective. Preclinical studies and clinical trials are lengthy and expensive and the
historical rate of failure for drug candidates is high. The results from preclinical studies of a
drug candidate may not predict the results that will be obtained in human clinical trials.
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We, the FDA or other applicable regulatory authorities may prohibit the initiation or suspend
clinical trials of a drug candidate at any time if we or they believe the persons participating in
such clinical trials are being exposed to unacceptable health risks or for other reasons. The
observation of adverse side effects in a clinical trial may result in the FDA or foreign regulatory
authorities refusing to approve a particular drug candidate for any or all indications of use.
Additionally, adverse or inconclusive clinical trial results concerning any of our drug candidates
could require us to conduct additional clinical trials, result in increased costs, significantly
delay the submission of applications seeking marketing approval for such drug candidates, result in
a narrower indication than was originally sought or result in a decision to discontinue development
of such drug candidates. Even if we successfully complete our clinical trials with respect to our
drug candidates, we may not receive regulatory approval for such candidate.
Clinical trials require sufficient patient enrollment, which is a function of many factors,
including the size of the patient population, the nature of the protocol, the proximity of patients
to clinical sites, the availability of effective treatments for the relevant disease, the
eligibility criteria for the clinical trial and other clinical trials evaluating other
investigational agents for the same or similar uses, which may compete with us for patient
enrollment. Delays in patient enrollment can result in increased costs and longer development
times.
We cannot predict whether we will encounter additional problems with any of our completed,
ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend
our clinical trials, delay or suspend patient enrollment into our clinical trials or delay the
analysis of data from our completed or ongoing clinical trials. Delays in the development of our
drug candidates would delay our ability to seek and potentially obtain regulatory approvals,
increase expenses associated with clinical development and likely increase the volatility of the
price of our common stock. Any of the following could suspend, terminate or delay the completion of
our ongoing, or the initiation of our planned, clinical trials:
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discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials; |
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delays in obtaining, or the inability to obtain, required approvals from, or suspensions or termination by, institutional review
boards or other governing entities at clinical sites selected for participation in our clinical trials; |
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delays in enrolling participants into clinical trials; |
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lower than anticipated retention of participants in clinical trials; |
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insufficient supply or deficient quality of drug candidate materials or other materials necessary to conduct our clinical trials; |
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serious or unexpected drug-related side effects experienced by participants in our clinical trials; or |
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negative results of clinical trials. |
If the results of our ongoing or planned clinical trials for our drug candidates are not
available when we expect or if we encounter any delay in the analysis of data from our preclinical
studies and clinical trials:
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we may be unable to commence human clinical trials of any drug candidates; |
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GSK may be unable to continue human clinical trials of 761 or commence human clinical trials of any
other licensed compound due to the clinical hold imposed by the FDA on 761 in February 2011; |
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Novartis may choose not to license our drug candidates and we may not be able to enter into other
collaborative arrangements for any of our other drug candidates; or |
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we may not have the financial resources to continue the research and development of our drug candidates. |
If our drug candidates fail to obtain United States and/or foreign regulatory approval, we and our
partners will be unable to commercialize our drug candidates.
Each of our drug candidates is subject to extensive governmental regulations relating to
development, clinical trials, manufacturing and commercialization. Rigorous preclinical studies and
clinical trials and an extensive regulatory approval process are required in the United States and
in many foreign jurisdictions prior to the commercial sale of any drug candidates. Before any drug
candidate can be approved for sale, we, or GSK, in the case of an NNRTI, including 761, or other
collaboration partners, must demonstrate that it can be manufactured in accordance with the FDAs
cGMP requirements. In addition, facilities where the principal commercial supply of a product is to
be manufactured must pass FDA inspection prior to approval. Satisfaction of these and other
regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays.
It is possible that none of the drug candidates we are currently developing, or have licensed to
GSK to develop, will obtain the appropriate regulatory approvals necessary to permit commercial
distribution.
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The time required for FDA review and other approvals is uncertain and typically takes a number
of years, depending upon the complexity of the drug candidate. Analysis of data obtained from
preclinical studies and clinical trials is subject to confirmation and interpretation by regulatory
authorities, which could delay, limit or prevent regulatory approval. We or one of our partners may
also encounter unanticipated delays or increased costs due to government regulation from future
legislation or administrative action, changes in FDA policy during the period of product
development, clinical trials and FDA regulatory review.
Any delay in obtaining or failure to obtain required approvals could materially adversely
affect our ability or that of a partner to generate revenues from a particular drug candidate. For
example, in September 2010, the FDA placed a clinical hold on IDX184 and IDX320, two of our drug
candidates for the treatment of HCV. We discontinued the clinical development of IDX320 and in
February 2011, the full clinical hold on IDX184 was removed by the FDA and the program was placed
on partial clinical hold. In February 2011, GSK informed us that the FDA placed 761 on clinical
hold and we do not know whether or when the FDA will allow GSK to continue development of 761.
Furthermore, any regulatory approval to market a product may be subject to limitations on the
indicated uses for which we or a partner may market the product. These restrictions may limit the
size of the market for the product. Additionally, drug candidates we or our partners successfully
develop could be subject to post market surveillance and testing.
We are also subject to numerous foreign regulatory requirements governing the conduct of
clinical trials, and we, with our partners, are subject to numerous foreign regulatory requirements
relating to manufacturing and marketing authorization, pricing and third-party reimbursement. The
foreign regulatory approval processes include all of the risks associated with FDA approval
described above as well as risks attributable to the satisfaction of local regulations in foreign
jurisdictions. Approval by any one regulatory authority does not assure approval by regulatory
authorities in other jurisdictions. Many foreign regulatory authorities, including those in the
European Union and in China, have different approval procedures than those required by the FDA and
may impose additional testing requirements for our drug candidates. Any failure or delay in
obtaining such marketing authorizations for our drug candidates would have a material adverse
effect on our business.
Our products will be subject to ongoing regulatory review even after approval to market such
products is obtained. If we or our partners fail to comply with applicable United States and
foreign regulations, we or our partners could lose approvals that we or our partners have been
granted and our business would be seriously harmed.
Even after approval, any drug product that we or our collaboration partners successfully
develop will remain subject to continuing regulatory review, including the review of clinical
results, which are reported after our product becomes commercially available. The marketing claims
we or our collaboration partners are permitted to make in labeling or advertising regarding our
marketed drugs in the United States will be limited to those specified in any FDA approval, and in
other markets such as the European Union, to the corresponding regulatory approvals. Any
manufacturer we or our collaboration partners use to make approved products will be subject to
periodic review and inspection by the FDA or other similar regulatory authorities in the European
Union and other jurisdictions. We and our collaboration partners are required to report any serious
and unexpected adverse experiences and certain quality problems with our products and make other
periodic reports to the FDA or other similar regulatory authorities in the European Union and other
jurisdictions. The subsequent discovery of previously unknown problems with the drug, manufacturer
or facility may result in restrictions on the drug manufacturer or facility, including withdrawal
of the drug from the market. We do not have, and currently do not intend to develop, the ability to
manufacture material at commercial scale or for our clinical trials. Our reliance on third-party
manufacturers entails risks to which we would not be subject if we manufactured products ourselves,
including reliance on such manufacturers for regulatory compliance. Certain changes to an approved
product, including the way it is manufactured or promoted, often require prior approval from
regulatory authorities before the modified product may be marketed.
If we or our collaboration partners fail to comply with applicable continuing regulatory
requirements, we or our collaboration partners may be subject to civil penalties, suspension or
withdrawal of any regulatory approval obtained, product recalls and seizures, injunctions,
operating restrictions and criminal prosecutions and penalties.
If we or our partners fail to comply with ongoing regulatory requirements after receipt of approval
to commercialize a product, we or our partners may be subject to significant sanctions imposed by
the FDA, EMEA or other United States and foreign regulatory authorities.
The research, testing, manufacturing and marketing of drug candidates and products are subject
to extensive regulation by numerous regulatory authorities in the United States and other
countries. Failure to comply with these requirements may subject a company to administrative or
judicially imposed sanctions. These enforcement actions may include, without limitation:
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warning letters and other regulatory authority communications
objecting to matters such as promotional materials and requiring
corrective action such as revised communications to healthcare
practitioners; |
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civil penalties; |
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criminal penalties; |
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injunctions; |
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product seizure or detention; |
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product recalls; |
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total or partial suspension of manufacturing; and |
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FDA refusal to review or approve pending new drug applications or
supplements to new drug applications for previously approved products
and/or similar rejections of marketing applications or supplements by
foreign regulatory authorities. |
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The imposition of one or more of these sanctions on us or one of our partners could have a
material adverse effect on our business.
If we do not comply with laws regulating the protection of the environment and health and human
safety, our business could be adversely affected.
Our research and development activities involve the controlled use of hazardous materials,
chemicals and various radioactive compounds. Although we believe that our safety procedures for
handling and disposing of these materials comply with the standards prescribed by state and federal
laws and regulations, the risk of accidental contamination or injury from these materials cannot be
eliminated. If an accident occurs, we could be held liable for resulting damages, which could be
substantial. We are also subject to numerous environmental, health and workplace safety laws and
regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and
the handling of biohazardous materials. Although we maintain workers compensation insurance to
cover us for costs we may incur due to injuries to our employees resulting from the use of these
materials and environmental liability insurance to cover us for costs
associated with environmental or toxic tort claims that may be asserted against us, this
insurance may not provide adequate coverage against all potential liabilities. Additional federal,
state, foreign and local laws and regulations affecting our operations may be adopted in the
future. We may incur substantial costs to comply with these laws or regulations. Additionally, we
may incur substantial fines or penalties if we violate any of these laws or regulations.
Growing availability of specialty pharmaceuticals may lead to increased focus of cost containment.
Specialty pharmaceuticals refer to medicines that treat rare or life-threatening conditions
that have smaller patient populations, such as certain types of cancer, multiple sclerosis, HBV,
HCV and HIV. The growing availability and use of innovative specialty pharmaceuticals, combined
with their relative higher cost as compared to other types of pharmaceutical products, is beginning
to generate significant payer interest in developing cost containment strategies targeted to this
sector. While the impact on our payers efforts to control access and pricing of specialty
pharmaceuticals has been limited to date, our portfolio of specialty products, combined with the
increasing use of health technology assessment in markets around the world and the deteriorating
finances of governments, may lead to a more significant adverse business impact in the future.
Factors Related to Our Relationship with Novartis
Novartis has substantial control over us and could delay or prevent a change in corporate control.
As of February 15, 2011, Novartis owned approximately 43% of our outstanding common stock. For
so long as Novartis owns 19.4% of our voting stock, Novartis has the ability to delay or prevent a
change in control of Idenix that may be favored by other stockholders and otherwise exercise
substantial control over all corporate actions requiring stockholder approval including:
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the election of our directors; |
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any amendment of our restated certificate of incorporation or amended and restated by-laws; |
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the approval of mergers and other significant corporate transactions, including a sale of substantially all of our assets; or |
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the defeat of any non-negotiated takeover attempt that might otherwise benefit our other stockholders. |
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Novartis has the right to exercise control over certain corporate actions, strategic direction, our
research and development focus and other material decisions that may not otherwise require
stockholder approval as long as it holds at least 19.4% of our voting stock.
As long as Novartis and its affiliates own at least 19.4% of our voting stock, which we define
below, we cannot take certain actions without the consent of Novartis. These actions include:
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the authorization or issuance of additional shares of our capital stock or the capital stock of our subsidiaries, except for a
limited number of specified issuances; |
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any change or modification to the structure of our board of directors or a similar governing body of any of our subsidiaries; |
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any amendment or modification to any of our organizational documents or those of our subsidiaries; |
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the adoption of a three-year strategic plan; |
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the adoption of an annual operating plan and budget, if there is no approved strategic plan; |
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any decision that would result in a variance of total annual expenditures, capital or expense, in excess of 20% from the
approved three-year strategic plan; |
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any decision that would result in a variance in excess of the greater of $10.0 million or 20% of our profit or loss target in
the strategic plan or annual operating plan; |
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the acquisition of stock or assets of another entity that exceeds 10% of our consolidated net revenue, net income or net assets; |
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the sale, lease, license or other disposition of any assets or business which exceeds 10% of our net revenue, net income or net
assets; |
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the incurrence of any indebtedness by us or our subsidiaries for borrowed money in excess of $2.0 million; |
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any material change in the nature of our business or that of any of our subsidiaries; |
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any change in control of Idenix or any subsidiary; and |
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any dissolution or liquidation of Idenix or any subsidiary, or the commencement by us or any subsidiary of any action under
applicable bankruptcy, insolvency, reorganization or liquidation laws. |
Pursuant to the amended and restated stockholders agreement, dated July 27, 2004, among us,
Novartis and certain of our stockholders, we are obligated to use our reasonable best efforts to
nominate for election as directors at least two designees of Novartis for so long as Novartis and
its affiliates own at least 35% of our voting stock and at least one designee of Novartis for so
long as Novartis and its affiliates own at least 19.4% of our voting stock. In June 2009, we
elected a third representative from Novartis to our board of directors. This election was not
required by or subject to the stockholders agreement. We currently have two Novartis designees on
our board of directors as a result of one designee resigning from Novartis and therefore from our
board in August 2010.
Under the stockholders agreement, voting stock means our outstanding securities entitled to
vote in the election of directors, but does not include securities issued in connection with our
acquisition of all of the capital stock, or all or substantially all of the assets of another
entity, and shares of common stock issued upon exercise of stock options or stock awards pursuant
to compensation and equity incentive plans. Notwithstanding the foregoing, voting stock includes up
to approximately 1.4 million shares that were reserved as of May 8, 2003 for issuance under our
1998 equity incentive plan.
In January 2009, we amended the development and commercialization agreement to provide that
Novartis retains the exclusive option to obtain rights to drug candidates developed by us, or in
some cases licensed to us, so long as Novartis maintains ownership of 40% of our common stock,
rather than ownership of 51% of our common stock, as was the requirement prior to the execution of
this amendment.
Additionally, in January 2009, we amended an agreement with Novartis providing that so long as
Novartis and its affiliates own at least 40% of our common stock, Novartis consent is required for
the selection and appointment of our chief financial officer. Prior to this amendment, the
ownership requirement was 51%. If in Novartis reasonable judgment our chief financial officer is
not satisfactorily performing his or her duties, we are required to terminate his or her
employment.
Furthermore, under the terms of the stock purchase agreement, dated as of March 21, 2003,
among us, Novartis and substantially all of our then existing stockholders, Novartis is required to
make future contingent payments of up to $357.0 million to these stockholders if we achieve
predetermined development milestones with respect to specific HCV drug candidates. As a result, in
making determinations as to our annual operating plan and budget for the development of our drug
candidates, the interests of Novartis may be different than the interests of our other stockholders
and Novartis could exercise its approval rights in a manner that may not be in the best interests
of all of our stockholders.
29
We currently depend on Novartis for a significant portion of our revenues, for the continuing
commercialization of Tyzeka®/Sebivo®and for support in the development of
drug candidates Novartis could license from us in the future. If our development and
commercialization agreement with Novartis terminates, our business, in particular, the development
of our drug candidates and the commercialization of any products that we successfully develop could
be harmed.
In May 2003, we received a $75.0 million license fee from Novartis in connection with the
license of our then HBV drug candidates, telbivudine and valtorcitabine. In April 2007, we received
a $10.0 million milestone payment for regulatory approval of Sebivo® in China and in
June 2007, we received an additional $10.0 million milestone payment for regulatory approval of
Sebivo® in the European Union. Pursuant to the development and commercialization
agreement, as amended, Novartis also acquired options to license valopicitabine and additional drug
candidates from us. In March 2006, Novartis exercised its option and acquired a license to
valopicitabine. As a result, we received a $25.0 million license fee and the right to receive up to
an additional $45.0 million in license fee payments upon advancement of a specified HCV drug
candidate into phase III clinical trials. Assuming we successfully develop and commercialize our
drug candidates licensed by Novartis, under the terms of the development and commercialization
agreement, we are entitled to receive reimbursement of expenses we incur in connection with the
development of these drug candidates and additional milestone payments from Novartis. Additionally,
if any of the drug candidates we have licensed to Novartis are approved for commercialization, we
anticipate receiving proceeds in connection with the sales of such products. If Novartis exercises
the option to license other drug candidates that we discover, or in some cases, acquire, we are
entitled to receive license fees and milestone payments as well as reimbursement of expenses we
incur in the development of such drug candidates in accordance with development plans mutually
agreed with Novartis.
Under the existing terms of the development and commercialization agreement, we have the right
to co-promote and co-market with Novartis in the United States, United Kingdom, Germany, Italy,
France and Spain any products licensed by Novartis, excluding
Tyzeka®/Sebivo®. For Tyzeka®/Sebivo®, we acted as the
lead commercial party in the United States. Effective on October 1, 2007, we transferred to
Novartis our worldwide development, commercialization and manufacturing rights and obligations
related to telbivudine (Tyzeka®/Sebivo®). We receive royalty payments equal
to a percentage of net sales of Tyzeka®/Sebivo®, with such percentage
increasing according to specified tiers of net sales. The royalty percentage varies based on the
specified territory and the aggregate dollar amount of net sales.
Novartis may terminate the development and commercialization agreement in any country or with
respect to any product or drug candidate licensed under the development and commercialization
agreement for any reason with six months written notice. If the development and commercialization
agreement is terminated in whole or in part and we are unable to enter similar arrangements with
other collaborators or partners, our business would be materially adversely affected.
Novartis has the option to license from us drug candidates we discover or, in some cases, acquire.
If Novartis does not exercise its option or disputes the adequacy of the notice provided by us
pertaining to the drug candidate, or after we provide notice, delays its decision to exercise such
option with respect to a drug candidate, our development, manufacture and/or commercialization of
such drug candidate may be substantially delayed or limited.
Our drug development programs and potential commercialization of our drug candidates will
require substantial additional funding. In addition to its license of
Tyzeka®/Sebivo®, valtorcitabine and valopicitabine, Novartis has the option
under the development and commercialization agreement to license our other drug candidates.
Furthermore, under the development and commercialization agreement, we must provide Novartis
with notice and a data package as part of Novartis consideration to license a drug candidate from
us. This notice includes information regarding the efficacy, safety and such other related material
information from the final data set for the relevant clinical trial for the drug candidate, as well
as a proposed development plan and proposed licensing terms. The development and commercialization
agreement is not specific as to the exact content of the information required in such notice. If
Novartis disputes the adequacy of the notice or data package, Novartis may argue that it is
entitled to additional information or data, which would likely lead to a delay in its review of our
drug candidate. Potential disputes over the adequacy of the notice and data package we provide
Novartis may cause delays in our development programs in order to resolve any disputes with
Novartis over the adequacy of such material. This could require substantial financial resources and
could take a significant amount of time to complete.
If Novartis elects not to exercise such option, we may be required to seek other collaboration
arrangements to provide funds necessary to enable us to develop such drug candidates. In October
2009, Novartis waived its option to license IDX184. As a result, we retain the worldwide rights to
develop, manufacture, commercialize and license IDX184. We are currently seeking a partner who will
assist in the future development and commercialization of this drug candidate. We may not be
successful in our efforts to enter into a collaboration arrangement with respect to a drug
candidate not licensed by Novartis and we may not have sufficient funds to develop such drug
candidate internally. As a result, our business would be adversely affected. In addition, the
negotiation of a collaborative agreement is time consuming and could, even if successful, delay the
development, manufacture and/or commercialization of a drug candidate and the terms of the
collaboration agreements may not be favorable to us.
30
If we breach any of the numerous representations and warranties we made to Novartis under the
development and commercialization agreement or the stock purchase agreement, Novartis has the right
to seek indemnification from us for damages it suffers as a result of such breach. These amounts
could be substantial.
We have agreed to indemnify Novartis and its affiliates against losses suffered as a result of
our breach of representations and warranties in the development and commercialization agreement and
the stock purchase agreement. Under the development and commercialization agreement and stock
purchase agreement, we made numerous representations and warranties to Novartis regarding our HCV
and HBV drug candidates, including representations regarding our ownership of and licensed rights
to the inventions and discoveries relating to such drug candidates. If one or more of our
representations or warranties were subsequently determined not to be true at the time we made them
to Novartis, we would be in breach of these agreements. In the event of a breach by us, Novartis
has the right to seek indemnification from us and, under certain circumstances, us and our
stockholders who sold shares to Novartis, which include many of our directors and officers, for
damages suffered by Novartis as a result of such breach. The amounts for which we could become
liable to Novartis could be substantial.
In May 2004, we entered into a settlement agreement with UAB, relating to our ownership of our
former chief executive officers, Jean-Pierre Sommadossi, Ph.D., inventorship interest in certain
of our patents and patent applications, including patent applications covering our HCV drug
candidates. Under the terms of the settlement agreement, we agreed to make payments to UAB,
including an initial payment made in 2004 in the amount of $2.0 million, as well as regulatory
milestone payments and payments relating to net sales of certain products. Novartis may seek to
recover from us and, under certain circumstances, us and our stockholders who sold shares to
Novartis, which include many of our officers and directors, the losses it suffers as a result of
any breach of the representations and warranties we made relating to our HCV drug candidates and
may assert that such losses include the settlement payments.
In July 2008, we, our former chief executive officer, in his individual capacity, the
University of Montpellier and CNRS entered into a settlement agreement with UAB, UABRF, and Emory
University. Pursuant to this settlement agreement, all contractual disputes relating to patents
covering the use of certain synthetic nucleosides for the treatment of HBV and all litigation
matters relating to patents and patent applications related to the use of ß-L-2-deoxy-nucleosides
for the treatment of HBV assigned to one or more of Idenix, CNRS, and the University of Montpellier
and which cover the use of telbivudine (Tyzeka®/Sebivo®) for the treatment of
HBV have been resolved. Under the terms of the settlement, we paid UABRF (on behalf of UAB and
Emory University) a $4.0 million upfront payment and will make additional payments to UABRF equal
to 20% of all royalty payments received by us from Novartis based on worldwide sales of
telbivudine, subject to minimum payment obligations aggregating $11.0 million. Novartis may seek to
recover from us and, under certain circumstances, us and
those of our officers, directors and other stockholders who sold shares to Novartis, such
losses and other losses it suffers as a result of any breach of the representations and warranties
we made relating to our HBV drug candidates and may assert that such losses include the settlement
payments.
If we materially breach our obligations or covenants arising under the development and
commercialization agreement with Novartis, we may lose our rights to develop or commercialize our
drug candidates.
We have significant obligations to Novartis under the development and commercialization
agreement. The obligations to which we are subject include the responsibility for developing and,
in some countries, co-promoting or co-marketing the products licensed to Novartis in accordance
with plans and budgets subject to Novartis approval. The covenants and agreements we made when
entering into the development and commercialization agreement include covenants relating to
payments of our required portion of development expenses under the development and
commercialization agreement, compliance with certain third-party license agreements, the conduct of
our clinical studies and activities relating to the commercialization of any products that we
successfully develop. If we materially breach this agreement and are unable within an agreed time
period to cure such breach, the agreement may be terminated and we may be required to grant
Novartis an exclusive license to develop, manufacture and/or sell such products. Although such a
license would be subject to payment of a royalty by Novartis to be negotiated in good faith, we and
Novartis have stipulated that no such payments would permit the breaching party to receive more
than 90% of the net benefit it was entitled to receive before the agreement was terminated.
Accordingly, if we materially breach our obligations under the development and commercialization
agreement, we may lose our rights to develop our drug candidates or commercialize our successfully
developed products and may receive lower payments from Novartis than we had anticipated.
If we issue capital stock, in certain situations, Novartis will be able to purchase shares at par
value to maintain its percentage ownership in Idenix and, if that occurs, this could cause
dilution. In addition, Novartis has the right, under specified circumstances, to purchase a pro
rata portion of other shares that we may issue.
Under the terms of the stockholders agreement, Novartis has the right to purchase, at par
value of $0.001 per share, such number of shares of our capital stock that would be required to
maintain its percentage ownership of our voting stock if we issue shares of capital stock in
connection with the acquisition or in-licensing of technology through the issuance of up to 5% of
our stock in any 24-month period. If Novartis elects to maintain its percentage ownership of our
voting stock under the rights described above, Novartis will be buying such shares at a price, that
is substantially below market value, which would cause dilution. This right of Novartis will remain
in effect until the earlier of:
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the date that Novartis and its affiliates own less than 19.4% of our voting stock; or |
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the date that Novartis becomes obligated under the stock purchase agreement to make
the additional future contingent payments of $357.0 million to our stockholders who
sold shares to Novartis in May 2003. |
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In addition to the right to purchase shares of our common stock at par value as described
above, Novartis has the right, subject to limited exceptions noted below, to purchase a pro rata
portion of shares of capital stock that we issue. The price that Novartis pays for these securities
would be the price that we offer such securities to third-parties, including the price paid by
persons who acquire shares of our capital stock pursuant to awards granted under stock compensation
or equity incentive plans. Novartis right to purchase a pro rata portion does not include:
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securities issuable in connection with any stock split, reverse stock split,
stock dividend or recapitalization that we undertake that affects all holders
of our common stock proportionately; |
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shares that Novartis has the right to purchase at par value, as described above; |
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shares of common stock issuable upon exercise of stock options and other awards
pursuant to our 1998 equity incentive plan; and |
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securities issuable in connection with our acquisition of all the capital stock
or all or substantially all of the assets of another entity. |
Novartis right to purchase shares includes a right to purchase securities that are
convertible into, or exchangeable for, our common stock, provided that Novartis right to purchase
stock in connection with options or other convertible securities issued to any of our directors,
officers, employees or consultants pursuant to any stock compensation or equity incentive plan will
not be triggered until the underlying equity security has been issued to the director, officer,
employee or consultant. Novartis has waived its right to purchase additional shares of our common
stock as a result of the shares of common stock we issued to GSK. Additionally, Novartis did not
purchase shares of our common stock pursuant to our underwritten offerings in August 2009 and in
April 2010 and Novartis ownership was subsequently diluted from approximately 53% prior to the
August 2009 offering to approximately 43% as of February 15, 2011.
If Novartis terminates or fails to perform its obligations under the development and
commercialization agreement, we may not be able to successfully commercialize our drug candidates
licensed to Novartis and the development and commercialization of our other drug candidates could
be delayed, curtailed or terminated.
Under the amended development and commercialization agreement, Novartis is solely responsible
for the worldwide development, commercialization and manufacturing rights to telbivudine. We expect
to co-promote or co-market with Novartis other products, if any, that Novartis has licensed or will
license from us which are successfully developed and approved for commercialization. As a result,
we will depend upon the success of the efforts of Novartis to manufacture, market and sell
Tyzeka®/Sebivo® and our other products, if any, that we successfully develop
and license to Novartis. However, we have limited control over the resources that Novartis may
devote to such manufacturing and commercialization efforts and, if Novartis does not devote
sufficient time and resources to such efforts, we may not realize the commercial or financial
benefits we anticipate, and our results of operations may be adversely affected.
In addition, Novartis has the right to terminate the development and commercialization
agreement with respect to any product, drug candidate or country with six months written notice to
us. If Novartis were to breach or terminate this agreement with us, the development or
commercialization of the affected drug candidate or product could be delayed, curtailed or
terminated because we may not have sufficient resources or capabilities, financial or otherwise, to
continue development and commercialization of the drug candidate, and we may not be successful in
entering into a collaboration with another third-party.
Novartis has the right to market and sell products that compete with the drug candidates and
products that we license to it and any competition by Novartis could have a material adverse effect
on our business.
Novartis may market, sell, promote or license competitive products. Novartis has significantly
greater financial, technical and human resources than we have and is better equipped to discover,
develop, manufacture and commercialize products. In addition, Novartis has more extensive
experience in preclinical studies and clinical trials, obtaining regulatory approvals and
manufacturing and marketing pharmaceutical products. In the event that Novartis competes with us,
our business could be materially and adversely affected.
Factors Related to Our Dependence on Third-Parties Other Than Novartis
If we seek to enter into collaboration agreements for any drug candidates other than those licensed
to Novartis and GSK and we are not successful in establishing such collaborations, we may not be
able to continue development of those drug candidates.
Our drug development programs and product commercialization efforts will require substantial
additional cash to fund expenses to be incurred in connection with these activities. While we have
entered into the development and commercialization agreement with Novartis in May 2003 and the GSK
license agreement in February 2009, we may seek to enter into additional collaboration agreements
with other pharmaceutical companies to fund all or part of the costs of drug development and
commercialization of drug candidates that Novartis does not license. We are currently seeking a
partner who will assist in the future development and commercialization of our drug candidate,
IDX184, for the treatment of HCV. We may not be able to enter into collaboration agreements and the
terms of any such collaboration agreements may not be favorable to us. If we are not successful in
our efforts to enter into a collaboration arrangement with respect to a drug candidate, we may not
have sufficient funds to develop such drug candidate or any other drug candidate internally.
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If we do not have sufficient funds to develop our drug candidates, we will not be able to
bring these drug candidates to market and generate revenue. As a result, our business will be
adversely affected. In addition, the inability to enter into collaboration agreements could delay
or preclude the development, manufacture and/or commercialization of a drug candidate and could
have a material adverse effect on our financial condition and results of operations because:
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we may be required to expend our own funds to advance the drug candidate to commercialization; |
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revenue from product sales could be delayed; or |
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we may elect not to develop or commercialize the drug candidate. |
Our license agreement with GSK is important to our business. The milestone payments and royalties
we could receive under our license agreement with GSK could be delayed, reduced or terminated if
GSK terminates or fails to perform its obligations under its agreement with us or if GSK is
unsuccessful in its sales efforts.
In February 2009, we entered into the GSK license agreement under which we granted GSK an
exclusive worldwide license to develop, manufacture and commercialize our NNRTI compounds,
including IDX899, now known as 761, for the treatment of human diseases, including HIV/AIDS. In
February 2011, GSK informed us that the FDA placed 761 on clinical hold. Our potential revenues
under this license agreement will consist primarily of development and sales milestones and royalty
payments based on worldwide annual net sales, if any, of an NNRTI compound, including 761, by GSK,
its affiliates and sublicensees. Milestone payments and royalties under this agreement will depend
solely on GSKs efforts, including development and sales efforts and enforcement of patents, which
we cannot control. If GSK does not devote sufficient time and resources to its license agreement
with us or focuses its efforts in countries where we do not hold patents, we may not receive any
such milestone or royalty payment and our results of operations may be adversely affected.
If GSK were to breach or terminate its agreement with us or fail to perform its obligations to
us in a timely manner, the milestone payments and royalties we could receive under the GSK license
agreement could decrease or cease. Any delay or termination of this type
could have a material adverse effect on our financial condition and results of operations
because we may lose technology rights and milestone or royalty payments from GSK and/or revenues
from product sales, if any, could be delayed, reduced or terminated.
Our collaborations with outside scientists may be subject to restriction and change.
We work with chemists and biologists at academic and other institutions that assist us in our
research and development efforts. Many of our drug candidates were discovered with the research and
development assistance of these chemists and biologists. Many of the scientists who have
contributed to the discovery and development of our drug candidates are not our employees and may
have other commitments that would limit their future availability to us. Although our scientific
advisors and collaborators generally agree not to do competing work, if a conflict of interest
between their work for us and their work for another entity arises, we may lose their services.
We have depended on third-party manufacturers to manufacture products for us. If in the future we
manufacture any of our products, we will be required to incur significant costs and devote
significant efforts to establish these capabilities.
We have relied upon third-parties to produce material for preclinical and clinical studies and
may continue to do so in the future. Although we believe that we will not have any material supply
issues, we cannot be certain that we will be able to obtain long-term supply arrangements of those
materials on acceptable terms. We also expect to rely on third-parties to produce materials
required for clinical trials and for the commercial production of certain of our products if we
succeed in obtaining necessary regulatory approvals. If we are unable to arrange for third-party
manufacturing, or to do so on commercially reasonable terms, we may not be able to complete
development of our products or market them.
Reliance on third-party manufacturers entails risks to which we would not be subject if we
manufactured products ourselves, including reliance on the third-party for regulatory compliance
and quality assurance, the possibility of breach by the third-party of agreements related to supply
because of factors beyond our control and the possibility of termination or nonrenewal of the
agreement by the third-party, based on its own business priorities, at a time that is costly or
damaging to us.
In addition, the FDA and other regulatory authorities require that our products be
manufactured according to cGMP regulations. Any failure by us or our third-party manufacturers to
comply with cGMPs and/or our failure to scale up our manufacturing processes could lead to a delay
in, or failure to obtain, regulatory approval. In addition, such failure could be the basis for
action by the FDA to withdraw approvals for drug candidates previously granted to us and for other
regulatory action.
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Factors Related to Patents and Licenses
If we are unable to adequately protect our patents and licenses related to our drug candidates, or
if we infringe the rights of others, it may not be possible to successfully commercialize products
that we develop.
Our success will depend in part on our ability to obtain and maintain patent protection both
in the United States and in other countries for any products we successfully develop. The patents
and patent applications in our patent portfolio are either owned by us, exclusively licensed to us,
or co-owned by us and others and exclusively licensed to us. Our ability to protect any products we
successfully develop from unauthorized or infringing use by third-parties depends substantially on
our ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards
relating to the patentability, validity and enforceability of patents covering pharmaceutical
inventions and the scope of claims made under these patents, our ability to obtain and enforce
patents is uncertain and involves complex legal and factual questions. Accordingly, rights under
any issued patents may not provide us with sufficient protection for any products we successfully
develop or provide sufficient protection to afford us a commercial advantage against our
competitors or their competitive products or processes. In addition, we cannot guarantee that any
patents will be issued from any pending or future patent applications owned by or licensed to us.
Even if patents have been issued or will be issued, we cannot guarantee that the claims of these
patents are, or will be, valid or enforceable, or provide us with any significant protection
against competitive products or otherwise be commercially valuable to us.
We may not have identified all patents, published applications or published literature that
may affect our business, either by blocking our ability to commercialize our drug candidates, by
preventing the patentability of our drug candidates by us, our licensors or co-owners, or by
covering the same or similar technologies that may invalidate our patents, limiting the scope of
our future patent claims or adversely affecting our ability to market our drug candidates. For
example, patent applications in the United States are maintained in confidence for up to 18 months
after their filing. In some cases, however, patent applications remain confidential in the U.S.
Patent and Trademark Office, which we refer to as the U.S. Patent Office, for the entire time
prior to issuance of a U.S. patent. Patent applications filed in countries outside the United
States are not typically published until at least 18 months from their first filing date.
Similarly, publication of discoveries in the scientific or patent literature often lags behind
actual discoveries. Therefore, we cannot be certain that we or our licensors or co-owners were the
first to invent, or the first to file, patent applications on our product or drug candidates or for
their uses. In the event that a third-party has also filed a U.S. patent application covering our
product or drug candidates or a similar invention, we may have to participate in an adversarial
proceeding, known as an interference, declared by the U.S. Patent Office to determine priority of
invention in the United States. The costs of these proceedings could be substantial and it is
possible that our efforts could be unsuccessful, potentially resulting in a loss of our U.S. patent
position. The laws of some foreign jurisdictions do not protect intellectual property rights to the
same extent as in the United States and many companies have encountered significant difficulties in
protecting and defending such rights in foreign jurisdictions. If we
encounter such difficulties in protecting, or are otherwise precluded from effectively
protecting, our intellectual property rights in foreign jurisdictions, our business prospects could
be substantially harmed.
Since our HBV product, telbivudine, was a known compound before the filing of our patent
applications covering the use of this drug candidate to treat HBV, we cannot obtain patent
protection on telbivudine itself. As a result, we have obtained and maintain patents granted on the
method of using telbivudine as a medical therapy for the treatment of HBV.
In July 2008, we entered into a settlement agreement with UAB, UABRF and Emory University
relating to our telbivudine technology. Pursuant to this settlement agreement, all contractual
disputes relating to patents covering the use of certain synthetic nucleosides for the treatment of
HBV and all litigation matters relating to patents and patent applications related to the use of
ß-L-2-deoxy-nucleosides for the treatment of HBV assigned to one or more of Idenix, CNRS and the
University of Montpellier and which cover the use of telbivudine
(Tyzeka®/Sebivo®) for the treatment of HBV have been resolved. UAB also
agreed to abandon certain continuation patent applications it filed in July 2005. Under the terms
of the settlement, we paid UABRF (on behalf of UAB and Emory University) a $4.0 million upfront
payment and will make additional payments to UABRF equal to 20% of all royalty payments received by
us from Novartis based on worldwide sales of telbivudine, subject to minimum payment obligations in
the aggregate of $11.0 million.
In accordance with our patent strategy, we are attempting to obtain patent protection for our
HCV nucleoside/nucleotide polymerase inhibitor drug candidate, IDX184. We have filed U.S. and
foreign patent applications related to IDX184 itself, as well as to methods of treating HCV with
IDX184. Further, we are prosecuting U.S. and foreign patent applications, and have been granted
U.S. and foreign patents, claiming methods of treating HCV with nucleoside polymerase inhibitors
including compounds that relate to IDX184.
We are aware that a number of other companies have filed patent applications attempting to
cover broad classes of compounds and their use to treat HCV or infection by any member of the
Flaviviridae virus family to which HCV belongs. These classes of compounds might relate to
nucleoside polymerase inhibitors associated with IDX184. The companies include Merck & Co., Inc.,
Isis Pharmaceuticals, Inc., Ribapharm, Inc. (a wholly-owned subsidiary of Valeant Pharmaceuticals
International), Genelabs Technologies, Inc., Pharmasset, Inc. and Biota, Inc. (a subsidiary of
Biota Holdings Ltd.). A foreign country may grant patent rights covering our drug candidates to one
or more other companies. If that occurs, we may need to challenge the third-party patent rights,
and if we do not challenge or are not successful with the challenge, we will need to obtain a
license that might not be available on commercially reasonable terms or at all. The U.S. Patent
Office may grant patent rights covering our drug candidates to one or more other companies. If that
occurs, we may need to challenge the third-party patent rights, and if we do not challenge or are
not successful with the challenge, we will need to obtain a license that might not be available at
all or on commercially reasonable terms.
34
In accordance with our patent strategy, we are attempting to obtain, and in some jurisdictions
have obtained, patent protection for our HIV drug candidate IDX899, which we licensed to GSK in
2009. We have filed and are prosecuting U.S. and foreign patent applications directed to IDX899
itself, as well as methods of treating HIV with IDX899.
A number of companies have filed patent applications and have obtained patents covering
general methods for the treatment of HBV, HCV and HIV that could materially affect the ability to
develop and commercialize Tyzeka®/Sebivo® and other drug candidates we may
develop in the future. For example, we are aware that Apath, LLC has obtained broad patents
covering HCV proteins, nucleic acids, diagnostics and drug screens. If we need to use these
patented materials or methods to develop any of our HCV drug candidates and the materials or
methods fall outside certain safe harbors in the laws governing patent infringement, we will need
to buy these products from a licensee of the company authorized to sell such products or we will
require a license from one or more companies, which may not be available to us on commercially
reasonable terms or at all. This could materially affect or preclude our ability to develop and
sell our HCV drug candidates.
If we find that any drug candidates we are developing should be used in combination with a
product covered by a patent held by another company or institution, and that a labeling instruction
is required in product packaging recommending that combination, we could be accused of, or held
liable for, infringement or inducement of infringement of certain third-party patents claims
covering the product recommended for co-administration with our product. In that case, we may be
required to obtain a license from the other company or institution to provide the required or
desired package labeling, which may not be available on commercially reasonable terms or at all.
Litigation and disputes related to intellectual property matters occur frequently in the
biopharmaceutical industry. Litigation regarding patents, patent applications and other proprietary
rights may be expensive and time consuming. If we are unsuccessful in litigation concerning patents
or patent applications owned or co-owned by us or licensed to us, we may not be able to protect our
products from competition or we may be precluded from selling our products. If we are involved in
such litigation, it could cause delays in bringing drug candidates to market and harm our ability
to operate. Such litigation could take place in the United States in a federal court or in the U.S.
Patent Office. The litigation could also take place in a foreign country, in either the courts or
the patent office of that country.
Our success will depend in part on our ability to uphold and enforce patents or patent
applications owned or co-owned by us or licensed to us, which cover products we successfully
develop. Proceedings involving our patents or patent applications could result in adverse decisions
regarding:
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ownership of patents and patent applications; |
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the patentability of our inventions relating to our products and drug candidates; and/or |
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the enforceability, validity or scope of protection offered by our patents relating to our products and drug candidates. |
Even if we are successful in these proceedings, we may incur substantial costs and divert
managements time and attention in pursuing these proceedings, which could have a material adverse
effect on us.
In May 2004, we and our former chief executive officer, Jean-Pierre Sommadossi, Ph.D., entered
into a settlement agreement with UAB resolving a dispute regarding ownership of inventions and
discoveries made by our former chief executive officer during the period from November 1999 to
November 2002, at which time our former chief executive officer was on sabbatical and then unpaid
leave from his position at UAB. The patent applications we filed with respect to such inventions
and discoveries include the patent applications covering valopicitabine and IDX184.
Under the terms of the settlement agreement, we agreed to make a $2.0 million initial payment
to UAB, as well as other contingent payments based upon the commercial launch of other HCV products
discovered or invented by our former chief executive officer during his sabbatical and unpaid
leave. In addition, UAB and UABRF have each agreed that neither of them has any right, title or
ownership interest in these inventions and discoveries. Under the development and commercialization
agreement and stock purchase agreement, we made numerous representations and warranties to Novartis
regarding our HCV program, including representations regarding our ownership of the inventions and
discoveries. If one or more of our representations or warranties were subsequently determined not
to be true at the time we made them to Novartis, we would be in breach of these agreements. In the
event of a breach by us, Novartis has the right to seek indemnification from us and, under certain
circumstances, us and our stockholders who sold shares to Novartis, which include many of our
directors and officers, for damages suffered by Novartis as a result of such breach. The amounts
for which we could be liable to Novartis could be substantial.
Our success will also depend in part on our ability to avoid infringement of the patent rights
of others. If it is determined that we do infringe a patent right of another, we may be required to
seek a license (which may not be available on commercially reasonable terms or at all), defend an
infringement action or challenge the validity of the patents in court. Patent litigation is costly
and time consuming. We may not have sufficient resources to bring these actions to a successful
conclusion. In addition, if we are not successful in infringement litigation and we do not license
or develop non-infringing technology, we may:
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incur substantial monetary damages; |
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encounter significant delays in bringing our drug candidates to market; and/or |
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|
be precluded from participating in the manufacture, use or sale of our drug
candidates or methods of treatment requiring licenses. |
35
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade
secrets and other proprietary information.
To protect our proprietary technology and processes, we also rely in part on confidentiality
agreements with our corporate collaborators, employees, consultants, outside scientific
collaborators and sponsored researchers and other advisors. These agreements may not effectively
prevent disclosure of confidential information and may not provide an adequate remedy in the event
of unauthorized disclosure of confidential information. In addition, others may independently
discover our trade secrets and confidential information and in such cases we could not assert any
trade secret rights against such parties. Costly and time consuming litigation could be necessary
to enforce and determine the scope of our proprietary rights and failure to obtain or maintain
trade secret protection could adversely affect our competitive business position.
If any of our agreements that grant us the exclusive right to make, use and sell our drug
candidates are terminated, we and/or our collaboration partners may be unable to develop or
commercialize our drug candidates.
We, together with Novartis, entered into an amended and restated agreement with CNRS and the
University of Montpellier, co-owners of the patents and patent applications covering
Tyzeka®/Sebivo® and valtorcitabine. This agreement covers both the
cooperative research program and the terms of our exclusive right to exploit the results of the
cooperative research, including Tyzeka®/Sebivo® and valtorcitabine. The
cooperative research program with CNRS and the University of Montpellier ended in December 2006
although many of the terms remain in effect for the duration of the patent life of the affected
products. We, together with Novartis, and in 2009 with GSK, have also entered into two agreements
with the University of Cagliari, the co-owner of the patents and patent applications covering some
of our HCV drug candidates and certain HIV drug candidates. One agreement with the University of
Cagliari covers our cooperative research program and the other agreement is an exclusive license to
develop and sell jointly created drug candidates. Under the amended and restated agreement with
CNRS and the University of Montpellier and the license agreement, as amended, with the University
of Cagliari, we obtained from our co-owners the exclusive right to exploit these drug candidates.
Subject to certain rights afforded to Novartis and to GSK as they relate to the
license agreement with the University of Cagliari, these agreements can be terminated by
either party in circumstances such as the occurrence of an uncured breach by the non-terminating
party. The termination of our rights, including patent rights, under the agreement with CNRS and
the University of Montpellier or the license agreement, as amended, with the University of Cagliari
would have a material adverse effect on our business and could prevent us from developing a drug
candidate or selling a product. In addition, these agreements provide that we pay certain costs of
patent prosecution, maintenance and enforcement. These costs could be substantial. Our inability or
failure to pay these costs could result in the termination of the agreements or certain rights
under them.
Under our amended and restated agreement with CNRS and the University of Montpellier and our
license agreement, as amended, with the University of Cagliari, we and Novartis have the right to
exploit and license our co-owned drug candidates. Under our license agreement, as amended, with the
University of Cagliari, we and GSK have the right to exploit and license our co-owned drug
candidates. However, our agreements with CNRS and the University of Montpellier and with the
University of Cagliari are currently governed by, and will be interpreted and enforced under,
French and Italian law, respectively, which are different in substantial respects from United
States law and which may be unfavorable to us in material respects. Under French law, co-owners of
intellectual property cannot exploit, assign or license their individual rights without the
permission of the co-owners. Similarly, under Italian law, co-owners of intellectual property
cannot exploit or license their individual rights without the permission of the co-owners.
Accordingly, if our agreements with the University of Cagliari terminate based on a breach, we may
not be able to exploit, license or otherwise convey to Novartis, GSK or other third-parties our
rights in our products or drug candidates for a desired commercial purpose without the consent of
the co-owner, which could materially affect our business and prevent us from developing our drug
candidates and selling our products.
Under United States law, a co-owner has the right to prevent the other co-owner from suing
infringers by refusing to join voluntarily in a suit to enforce a patent. Our amended and restated
agreement with CNRS and the University of Montpellier and our license agreement, as amended, with
the University of Cagliari provide that such parties will cooperate to enforce our jointly owned
patents on our products or drug candidates. If these agreements terminate or the parties
cooperation is not given or is withdrawn, or they refuse to join in litigation that requires their
participation, we may not be able to enforce these patent rights or protect our markets.
36
Factors Related to Our Common Stock
Our common stock may have a volatile trading price and low trading volume.
The market price of our common stock could be subject to significant fluctuations. Some of the
factors that may cause the market price of our common stock to fluctuate include:
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realization of license fees and achievement of milestones under our development and commercialization agreement with
Novartis; |
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realization of license fees, achievement of preclinical and clinical milestones and sales thresholds under the GSK license
agreement; |
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reductions in proceeds associated with Novartis right to maintain its percentage ownership of our voting stock when we
issue shares at a price below fair market value; |
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adverse developments regarding the safety and efficacy of Tyzeka®/Sebivo® or our other drug candidates; |
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the results of ongoing and planned clinical trials of our drug candidates; |
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|
developments in the market with respect to competing products or more generally the treatment of HBV, HCV or HIV; |
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the results of preclinical studies and planned clinical trials of our other discovery-stage programs; |
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future sales of, and the trading volume in, our common stock; |
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the timing and success of the launch of products, if any, we successfully develop; |
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|
future royalty payments received by us associated with sales of Tyzeka®/Sebivo®; |
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|
the entry into key agreements, including those related to the acquisition or in-licensing of new programs, or the
termination of key agreements; |
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|
the results and timing of regulatory actions relating to the approval of our drug candidates, including any decision by the
regulatory authorities to place a clinical hold on our drug candidates; |
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|
the initiation of, material developments in or conclusion of litigation to enforce or defend any of our intellectual
property rights; |
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the initiation of, material developments in or conclusion of litigation to defend products liability claims; |
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the failure of any of our drug candidates, if approved, to achieve commercial success; |
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the results of clinical trials conducted by others on drugs that would compete with our drug candidates; |
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issues in manufacturing our drug candidates or any approved products; |
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the loss of key employees; |
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adverse publicity related to our company, our products or our product candidates; |
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changes in estimates or recommendations by securities analysts who cover our common stock; |
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future financings through the issuance of equity or debt securities or otherwise; |
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changes in the structure of health care payment systems; |
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our cash position and period-to-period fluctuations in our financial results; |
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general and industry-specific economic conditions; and |
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the decision by Novartis to license a drug candidate that has completed a proof-of-concept clinical trial. |
Moreover, the stock markets in general have experienced substantial volatility that has often
been unrelated to the operating performance of individual companies. These broad market
fluctuations may also adversely affect the trading price of our common stock.
37
We do not anticipate paying cash dividends, so you must rely on stock price appreciation for any
return on your investment.
We anticipate retaining any future earnings for reinvestment in our research and development
programs. Therefore, we do not anticipate paying cash dividends in the future. As a result, only
appreciation of the price of our common stock will provide a return to stockholders. Investors
seeking cash dividends should not invest in our common stock.
Sales of additional shares of our common stock could result in dilution to existing stockholders
and cause the price of our common stock to decline.
Sales of substantial amounts of our common stock in the public market or the availability of
such shares for sale, could adversely affect the price of our common stock. In addition, the
issuance of common stock upon exercise of outstanding options could be dilutive and may cause the
market price for a share of our common stock to decline. As of February 15, 2011, we had 73,106,487
shares of common stock issued and outstanding, together with outstanding options to purchase
approximately 7,039,343 shares of common stock with a weighted average exercise price of $7.30 per
share.
Novartis and other holders of shares of common stock have rights, subject to certain
conditions, to require us to file registration statements covering their shares or to include their
shares in registration statements that we may file for ourselves or other stockholders.
An investment in our common stock may decline in value as a result of announcements of business
developments by us or our competitors.
The market price of our common stock is subject to substantial volatility as a result of
announcements by us or other companies in our industry. As a result, purchasers of our common stock
may not be able to sell their shares of common stock at or above the price at which they purchased
such stock. Announcements which may subject the price of our common stock to substantial volatility
include:
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our collaboration with Novartis; |
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our collaboration with GSK; |
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the results of our clinical trials pertaining to any of our drug candidates; |
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the results of discovery, preclinical studies and clinical trials by us or our competitors; |
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the acquisition of technologies, drug candidates or products by us or our competitors; |
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the development of new technologies, drug candidates or products by us or our competitors; |
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regulatory actions with respect to our drug candidates or products or those of our competitors, including those
relating to clinical trials, such as clinical holds imposed by regulatory authorities, marketing authorizations,
pricing and reimbursement; |
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the timing and success of launches of any product we successfully develop; |
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future royalty payments received by us associated with sales of Tyzeka®/Sebivo®; |
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the market acceptance of any products we successfully develop; |
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significant changes to our existing business model; |
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the initiation of, material developments in or conclusion of litigation to enforce or defend any of our
intellectual property rights; and |
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significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors. |
In addition, if we fail to reach an important research, development or commercialization
milestone or result by a publicly expected deadline, even if by only a small margin, there could be
a significant impact on the market price of our common stock. Additionally, as we approach the
announcement of important clinical data or other significant information and as we announce such
results and information, we expect the price of our common stock to be particularly volatile and
negative results would have a substantial negative impact on the price of our common stock.
38
We could be subject to class action litigation due to stock price volatility, which, if such
litigation occurs, will distract our management and could result in substantial costs or large
judgments against us.
The stock market frequently experiences extreme price and volume fluctuations. In September
2010, we experienced a significant decline in our stock price based on the FDAs decision to place
a clinical hold on IDX184 and IDX320, two of our drug candidates for the treatment of HCV. In
addition, the market prices of securities of companies in the biotechnology and pharmaceutical
industry have been extremely volatile and have experienced fluctuations that have often been
unrelated or disproportionate to the operating performance of these companies. These fluctuations
could adversely affect the market price of our common stock. In the past, securities class action
litigation has often been brought against companies following periods of volatility in the market
prices of their securities. Due to the volatility in our stock price, we may be the target of
similar litigation in the future.
Securities litigation could result in substantial costs and divert our managements attention
and resources, which could cause serious harm to our business, operating results and financial
condition.
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Item 1B. |
|
Unresolved Staff Comments |
None.
As of December 31, 2010, we leased approximately 111,000 square feet of office and laboratory
space. Our major leased properties are described below:
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Approximate Square |
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Property Location |
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Feet |
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Use |
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Lease Expiration Date |
Cambridge, MA |
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36,513 sq. ft. |
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Office Headquarters |
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December 2013 |
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39,014 sq. ft. |
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Office and Laboratory |
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December 2013 |
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Montpellier, France |
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35,215 sq. ft. |
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Office and Laboratory |
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April 2017 |
During 2010 and 2009, we subleased portions of our office headquarters in Cambridge, MA
to two third-parties. These sublease agreements expired in March 2010.
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Item 3. |
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Legal Proceedings |
None.
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Item 4. |
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[Removed and Reserved] |
PART II
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Item 5. |
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Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
Market Information
Our common stock has been traded on the NASDAQ Global Market under the symbol IDIX. On
February 15, 2011 the closing price of our common stock, as reported on the NASDAQ Global Market,
was $3.02 per share. The following table sets forth for the periods indicated the high and low
sales prices per share of our common stock, as reported by the NASDAQ Global Market.
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High |
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Low |
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2010 |
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First quarter |
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$ |
3.15 |
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$ |
2.12 |
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Second quarter |
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|
5.34 |
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|
|
2.80 |
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Third quarter |
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|
6.11 |
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|
2.57 |
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Fourth quarter |
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|
5.37 |
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|
3.07 |
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2009 |
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|
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|
First quarter |
|
$ |
6.78 |
|
|
$ |
1.86 |
|
Second quarter |
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|
4.15 |
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|
|
3.00 |
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Third quarter |
|
|
5.45 |
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|
|
2.75 |
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Fourth quarter |
|
|
3.22 |
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|
1.81 |
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39
Stockholders
On February 15, 2011, we had approximately 60 stockholders of record.
Dividends
We have never declared or paid cash dividends on our common stock. We currently intend to
reinvest our future earnings, if any, for use in the business and do not expect to declare or pay
cash dividends.
Repurchase of Securities
None.
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Item 6. |
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Selected Consolidated Financial Data |
The following selected financial data are derived from our audited consolidated financial
statements. This data should be read in conjunction with our audited consolidated financial
statements and related notes which are included elsewhere in this Annual Report on Form 10-K, and
Managements Discussion and Analysis of Financial Condition and Results of Operations included in
Item 7 below.
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Years Ended December 31, |
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2010 |
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2009 |
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2008 |
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2007 |
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2006 |
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|
|
(In Thousands, Except per Share Data) |
|
Consolidated Statements of Operations Data: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
10,222 |
|
|
$ |
12,616 |
|
|
$ |
10,049 |
|
|
$ |
68,028 |
|
|
$ |
67,377 |
|
Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
2,765 |
|
|
|
2,210 |
|
|
|
1,745 |
|
|
|
2,001 |
|
|
|
62 |
|
Research and development |
|
|
44,506 |
|
|
|
41,867 |
|
|
|
53,887 |
|
|
|
85,839 |
|
|
|
96,080 |
|
General and administrative |
|
|
23,439 |
|
|
|
21,467 |
|
|
|
27,130 |
|
|
|
63,348 |
|
|
|
56,954 |
|
Restructuring and impairment charges |
|
|
2,238 |
|
|
|
1,506 |
|
|
|
297 |
|
|
|
8,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
72,948 |
|
|
|
67,050 |
|
|
|
83,059 |
|
|
|
159,932 |
|
|
|
153,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(62,726 |
) |
|
|
(54,434 |
) |
|
|
(73,010 |
) |
|
|
(91,904 |
) |
|
|
(85,719 |
) |
Other income, net |
|
|
1,131 |
|
|
|
1,266 |
|
|
|
2,848 |
|
|
|
6,135 |
|
|
|
10,719 |
|
Gain on sale of equity securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,500 |
|
|
|
|
|
Income tax benefit (expense) |
|
|
40 |
|
|
|
(51 |
) |
|
|
(44 |
) |
|
|
(246 |
) |
|
|
(87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(61,555 |
) |
|
$ |
(53,219 |
) |
|
$ |
(70,206 |
) |
|
$ |
(82,515 |
) |
|
$ |
(75,087 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.87 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.24 |
) |
|
$ |
(1.47 |
) |
|
$ |
(1.34 |
) |
Shares used in computing basic and diluted
net loss per common share |
|
|
70,715 |
|
|
|
61,498 |
|
|
|
56,403 |
|
|
|
56,169 |
|
|
|
56,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
|
(In Thousands) |
|
Consolidated Balance Sheets Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,115 |
|
|
$ |
46,519 |
|
|
$ |
41,509 |
|
|
$ |
48,260 |
|
|
$ |
55,892 |
|
Working capital |
|
|
29,496 |
|
|
|
33,236 |
|
|
|
30,465 |
|
|
|
72,985 |
|
|
|
110,159 |
|
Total assets |
|
|
69,884 |
|
|
|
76,650 |
|
|
|
79,780 |
|
|
|
160,540 |
|
|
|
228,465 |
|
Deferred revenue |
|
|
2,623 |
|
|
|
1,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, related party |
|
|
3,036 |
|
|
|
6,155 |
|
|
|
5,965 |
|
|
|
8,372 |
|
|
|
13,490 |
|
Deferred revenue, net of current portion |
|
|
40,340 |
|
|
|
19,393 |
|
|
|
4,272 |
|
|
|
4,272 |
|
|
|
4,272 |
|
Deferred revenue, related party, net of current portion |
|
|
28,588 |
|
|
|
30,776 |
|
|
|
35,790 |
|
|
|
41,861 |
|
|
|
40,471 |
|
Other long-term liabilities |
|
|
12,058 |
|
|
|
13,590 |
|
|
|
12,789 |
|
|
|
14,835 |
|
|
|
2,251 |
|
Accumulated deficit |
|
|
(623,736 |
) |
|
|
(562,181 |
) |
|
|
(508,962 |
) |
|
|
(438,756 |
) |
|
|
(355,941 |
) |
Total stockholders equity (deficit) |
|
|
(31,096 |
) |
|
|
(5,453 |
) |
|
|
7,353 |
|
|
|
68,838 |
|
|
|
142,025 |
|
40
|
|
|
Item 7. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
Overview
Idenix Pharmaceuticals, Inc., which we reference together with our wholly owned subsidiaries
as Idenix, we, us or our, is a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral diseases with operations in the United States
and Europe. Currently, our primary research and development focus is on the treatment of patients
with hepatitis C virus, or HCV. Our HCV discovery program is focused on multiple classes of drugs,
which include nucleoside/nucleotide polymerase inhibitors, protease inhibitors, non-nucleoside
polymerase inhibitors and NS5A inhibitors. Our strategic goal is to develop all oral combinations
of direct-acting antiviral, or DAA, drug candidates that should eliminate the need for interferon
and/or ribavirin as the current treatment for HCV. Our objective is to develop low dose, once- or
twice-daily agents with broad genotypic activity that have low potential for drug-drug interaction,
high tolerability and are designed for use in multiple combination regimens. We will seek to build
a combination development strategy, both internally and with partners, to advance the future of HCV
treatments. We believe that nucleosides/nucleotides will have a significant role in a combination
DAA strategy for the treatment of HCV and therefore we are currently concentrating a substantial
amount of our discovery efforts on this class of drugs. We believe we have strong
nucleoside/nucleotide scientific expertise within our organization and should be able to leverage
our intellectual patent portfolio to discover multiple follow-ons and novel nucleoside/nucleotide
drug candidates.
In addition to our strategy of developing drugs for the treatment of HCV, we have also
developed products and drug candidates for the treatment of hepatitis B virus, or HBV, human
immunodeficiency virus type-1, or HIV, and acquired immune deficiency syndrome, or AIDS. We
successfully developed and received worldwide marketing approval for telbivudine
(Tyzeka®/Sebivo®), a drug for the treatment of HBV that
we licensed to Novartis Pharma AG, or Novartis. In 2007, we began receiving royalties from Novartis
based on a percentage of net sales of Tyzeka®/Sebivo®.
We also discovered and developed, through proof-of-concept clinical testing IDX899, a drug
candidate from the class of compounds known as non-nucleoside reverse transcriptase inhibitors, or
NNRTIs, for the treatment of HIV/AIDS. We licensed our NNRTI compounds, including IDX899, now known
as GSK2248761, or 761, to GlaxoSmithKline in February 2009. This agreement was assigned to ViiV
Healthcare Company, an affiliate of GlaxoSmithKline, which we refer to collectively as GSK. In
February 2011, GSK informed us that the U.S. Food and Drug Administration, or FDA, placed 761 on
clinical hold. GSK has full responsibility for the development of 761, including any regulatory
interactions.
In September 2010, the FDA placed two of our HCV drug candidates, IDX184 and IDX320, on
clinical hold. The hold was imposed due to three serious adverse events of elevated liver function
tests that were detected during post drug exposure safety visits following a 14-day drug-drug
interaction study of a combination of IDX184 and IDX320 in 20 healthy volunteers. We believe the
hepatotoxicity observed in this drug-drug interaction study was caused by IDX320 and therefore
discontinued the clinical development of this drug candidate. In February 2011, the full clinical
hold on IDX184 was removed. The program was placed on partial clinical hold, which allows us to
initiate a phase IIb 12-week clinical trial of IDX184 in combination with pegylated interferon and
ribavirin with safety evaluations of the patients that will be shared with the FDA at certain
intervals in the trial. We anticipate initiating this clinical trial in the second half of 2011.
41
The following table summarizes key information regarding our pipeline of HCV drug candidates
as well as Tyzeka®/Sebivo® and IDX899:
|
|
|
|
|
|
|
Product/Drug |
|
|
Indication |
|
Candidates/Programs |
|
Description |
|
|
|
|
|
HCV
|
|
Nucleoside/Nucleotide Polymerase Inhibitors
(IDX184)
|
|
Following a successfully completed proof-of-concept clinical
trial in treatment-naïve HCV genotype 1-infected patients, we
initiated a 14-day dose-ranging phase IIa clinical trial
evaluating IDX184 in combination with pegylated interferon and
ribavirin in treatment-naïve HCV genotype 1-infected patients.
This clinical trial was completed in the third quarter of 2010
and demonstrated that IDX184 is safe, well tolerated and has
potent HCV antiviral activity. We anticipate initiating a
phase IIb 12-week clinical trial in the second half of 2011.
Currently, our discovery efforts are concentrated on this
class of drugs to develop multiple follow-ons and novel
nucleoside/nucleotide drug candidates. |
|
|
|
|
|
|
|
Protease Inhibitors
(IDX320)
|
|
In the first quarter of 2010, we completed a double-blind, placebo-controlled
phase I clinical study evaluating single and multiple ascending doses of
IDX320 in healthy volunteers. Based on the favorable safety and
pharmacokinetic data from the phase I clinical study, we initiated a three-day
proof-of-concept clinical trial in treatment-naïve HCV genotype 1-infected
patients, which was completed in the third quarter of 2010. This three-day
clinical trial demonstrated that IDX320 had potent HCV antiviral activity. The
IDX320 program was discontinued following the three serious adverse events of
liver injury in the 14-day phase I drug-drug interaction study of IDX184 and
IDX320, discussed above. We have follow-on
drug candidates in the protease inhibitor class that are
currently in preclinical development. We anticipate selecting
a clinical candidate with broad genotypic activity in 2011. |
|
|
|
|
|
|
|
Combination DAA Study
(IDX184 and IDX320)
|
|
In the third quarter of 2010, we conducted a 14-day phase I
drug-drug interaction study of IDX184 and IDX320 in 20 healthy
volunteers. In September 2010, the FDA placed these drug
candidates on clinical hold due to three serious adverse
events of elevated liver function tests that were detected
during post drug exposure safety visits following this
drug-drug interaction study. We believe the hepatotoxicity
observed in this drug-drug interaction study was caused by
IDX320 and therefore discontinued the clinical development of
IDX320. In February 2011, the full clinical hold on IDX184 was
removed, which is described in more detail above. |
|
|
|
|
|
|
|
Non-Nucleoside Polymerase Inhibitor
(IDX375)
|
|
In the first quarter of 2010, we submitted a clinical trial
application, or CTA, for a free acid form of IDX375. In the
fourth quarter of 2010, we completed a phase I clinical study
evaluating single and multiple doses of IDX375 in healthy
volunteers. Based on the favorable safety and pharmacokinetic
data from the phase I clinical study, we initiated a three-day
proof-of-concept clinical trial in treatment-naïve genotype
1-infected patients in the fourth quarter of 2010. After three
days of dosing with 100 mg, 200 mg and 400 mg of IDX375
administered twice a day, mean HCV viral load reductions were
1.3, 2.3 and 2.7 log10 IU/mL, respectively. |
|
|
|
|
|
|
|
NS5A Inhibitors
|
|
During 2010, we selected two lead candidates from our NS5A
discovery program. We anticipate selecting a clinical
candidate with broad genotypic activity and submitting an
investigational new drug, or IND, or a CTA in 2011, assuming
positive results from IND-enabling preclinical studies. |
|
|
|
|
|
HBV
|
|
Tyzeka®/Sebivo®
(telbivudine)
(L-nucleoside)
|
|
Novartis has worldwide development, commercialization and
manufacturing rights and obligations related to telbivudine
(Tyzeka®/Sebivo®).
We receive royalty payments equal to a percentage of net sales
of
Tyzeka®/Sebivo®. |
|
|
|
|
|
HIV
|
|
Non-Nucleoside
Reverse Transcriptase Inhibitor
(IDX899 or 761)
|
|
In February 2009, we granted GSK an exclusive worldwide
license to develop, manufacture and commercialize IDX899, now
known as 761. This drug candidate has progressed through
long-term chronic toxicology studies and drug-drug interaction
studies in healthy volunteers. In the fourth quarter of 2010,
GSK initiated a phase IIb clinical study of 761 in
HIV-infected patients. In February 2011, GSK informed us that
the FDA placed 761 on clinical hold. GSK has full
responsibility for the development of 761, including any
regulatory interactions. |
All of our drug candidates are currently in preclinical or clinical development. To
commercialize any of our drug candidates, we will be required to obtain marketing authorization
approvals after successfully completing preclinical studies and clinical trials of such drug
candidates. We anticipate that we will incur significant additional third-party research and
development expenses that range from $200.0 million to $500.0 million for each drug candidate prior
to commercial launch. Our current estimates of additional third-party research and development
expenses do not include the cost of phase IIIb/IV clinical trials and other clinical trials that
are not required for regulatory approval. We use our employees and our infrastructure resources
across several projects, including our product discovery efforts. We do not allocate our
infrastructure costs on a project-by-project basis. As a result, we are unable to estimate the
internal costs incurred to date for our drug candidates on a project-by-project basis.
42
Set forth below were the third-party research and development expenses incurred in connection
with our significant preclinical studies and clinical trials:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disease |
|
|
|
Years Ended December 31, |
|
Indication |
|
Product/Drug Candidate |
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HCV |
|
Nucleotide Polymerase Inhibitors |
|
$ |
8,412 |
|
|
$ |
6,052 |
|
|
$ |
7,004 |
|
HCV |
|
Protease Inhibitors |
|
|
5,468 |
|
|
|
2,665 |
|
|
|
3,397 |
|
HCV |
|
Non-Nucleoside Polymerase Inhibitor |
|
|
3,678 |
|
|
|
3,537 |
|
|
|
2,308 |
|
HCV |
|
Combination DAA study |
|
|
747 |
|
|
|
|
|
|
|
|
|
HCV |
|
Preclinical discovery program and other |
|
|
513 |
|
|
|
517 |
|
|
|
1,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HBV |
|
Telbivudine (Tyzeka®/Sebivo®) and other |
|
|
|
|
|
|
15 |
|
|
|
286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HIV |
|
Non-Nucleoside Reverse Transcriptase Inhibitor |
|
|
(26 |
) |
|
|
(325 |
) |
|
|
3,978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
18,792 |
|
|
$ |
12,461 |
|
|
$ |
18,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
As noted in the table above, our current research and development is focused on the treatment
of HCV. In 2010, we had three drug candidates in clinical trials ranging from phase I to phase IIa
as well as a combination DAA study with two of our drug candidates. These clinical trials resulted
in a $6.0 million increase of HCV related third-party expenses as compared to 2009.
Novartis has the option to license our development-stage drug candidates after demonstration
of activity and safety in a proof-of-concept clinical trial so long as Novartis maintains at least
40% ownership of our common stock pursuant to our development, license and commercialization
agreement with Novartis, which we refer to as the development and commercialization agreement. If
Novartis licenses any of our drug candidates, Novartis is obligated to fund development expenses
that we incur in accordance with development plans agreed upon by us and Novartis. In October 2009,
Novartis waived its option to license IDX184. As a result, we retain the worldwide rights to
develop, manufacture, commercialize and license IDX184. We are currently seeking a partner who will
assist in the future development and commercialization of this drug candidate.
Pursuant to the license agreement we entered into with GSK in February 2009, which we refer to
as the GSK license agreement, described more fully below, GSK is solely responsible for the
worldwide development, manufacture and commercialization of our NNRTI compounds, including IDX899,
for the treatment of human diseases, including HIV/AIDS. Subject to certain conditions, GSK is also
responsible for the prosecution of our patents licensed to GSK under the GSK license agreement. We
do not expect to incur any additional development costs related to our NNRTI program, including
IDX899.
We have incurred significant losses each year since our inception in May 1998 and at December
31, 2010, we had an accumulated deficit of $623.7 million. We expect such losses to continue in the
foreseeable future. Historically, we have generated losses principally from costs associated with
research and development activities, including clinical trial costs, and general and administrative
activities. As a result of planned expenditures for future discovery and development activities, we
expect to incur additional operating losses for the foreseeable future. We believe that our current
cash and cash equivalents, the expected royalty payments associated with product sales of
Tyzeka®/Sebivo® and our ability and intent to manage
expenditures will be sufficient to satisfy our cash needs for at least the next 12 months from
December 31, 2010.
On October 28, 2010, Jean-Pierre Sommadossi, Ph.D., resigned from his positions as chairman of
the board of directors, president and chief executive officer. In connection with Dr. Sommadossis
resignation, he will receive severance payments of approximately $2.3 million, an option grant of
approximately 0.3 million shares and acceleration of all unvested options. Additionally, on October
28, 2010, the board of directors appointed Ronald C. Renaud, Jr., to serve as president and chief
executive officer.
Novartis Collaboration
In May 2003, we entered into a collaboration with Novartis relating to the worldwide
development and commercialization of our drug candidates. In May 2003, Novartis also purchased
approximately 54% of our common stock. Since this date, Novartis has had the ability to exercise
control over our strategic direction, research and development activities and other materials
business decisions.
We derived the majority of our total revenues from Novartis in 2010, 2009 and 2008 through the
recognition of license fees, milestone payments, research and development expense reimbursements
and royalty payments. Under the collaboration, Novartis paid us $117.2 million of non-refundable
payments that have been recorded as deferred revenue. These deferred payments are being recognized
over the development period of the licensed drug candidates, which represents the period of our
continuing obligations. Additionally, we also receive royalty payments from Novartis based on net
sales of Tyzeka®/Sebivo®.
We will continue to recognize revenue related to Novartis associated with the non-refundable
payments as well as the royalty payments. We also anticipate recognizing additional revenues from
our collaboration with Novartis, which may include license fees, development expense funding for
our drug candidates that Novartis may elect to subsequently license from us, as well as, regulatory
milestones and, if products are approved for sale, commercialization milestones and revenues
derived from sales, by us or Novartis, of our licensed drug candidates.
43
GlaxoSmithKline Collaboration
In February 2009, we entered into the GSK license agreement. In October 2009, GlaxoSmithKline
assigned the GSK license agreement to ViiV Healthcare Company, an affiliate of GlaxoSmithKline. The
GSK license agreement granted GSK an exclusive worldwide license to develop, manufacture and
commercialize our NNRTI compounds, including IDX899, for the treatment of human diseases, including
HIV/AIDS. In February 2009, we also entered into a stock purchase agreement with GSK, which we
refer to as the GSK stock purchase agreement. Under this agreement, GSK purchased approximately
2.5 million shares of our common stock at an aggregate purchase price of $17.0 million, or a per
share price of $6.87. These agreements became effective in March 2009.
In March 2009, we received a $34.0 million payment from GSK, which consisted of a $17.0
million license fee payment under the GSK license agreement and $17.0 million under the GSK stock
purchase agreement. In 2010, we received a $6.5 million milestone payment for the achievement of a
preclinical operational milestone and a $20.0 million milestone payment for the initiation of a
phase IIb clinical study related to the development of 761. We could also potentially receive up
to $390.0 million in additional milestone payments as well as double-digit tiered royalties on
worldwide product sales.
In February 2011, GSK informed us that the FDA placed 761 on clinical hold. GSK has full
responsibility for the development of 761, including any regulatory interactions.
Results of Operations
Comparison of Years Ended December 31, 2010 and 2009
Revenues
Revenues for the years ended December 31, 2010 and 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(In Thousands) |
|
Collaboration revenue related party: |
|
|
|
|
|
|
|
|
License fee revenue |
|
$ |
2,431 |
|
|
$ |
7,968 |
|
Royalty revenue |
|
|
3,800 |
|
|
|
3,704 |
|
Reimbursement of research and development costs |
|
|
|
|
|
|
45 |
|
|
|
|
|
|
|
|
|
|
|
6,231 |
|
|
|
11,717 |
|
Other revenue: |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
3,954 |
|
|
|
854 |
|
Government grants |
|
|
37 |
|
|
|
45 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
10,222 |
|
|
$ |
12,616 |
|
|
|
|
|
|
|
|
Collaboration
revenue related party consisted of revenue associated with our collaboration
with Novartis for the worldwide development and commercialization of our drug candidates. During
the years ended December 31, 2010, 2009 and 2008, collaboration
revenue related party was
comprised of the following:
|
|
|
license and other fees received from Novartis for the license of HBV and HCV drug
candidates, net of reductions for Novartis stock subscription rights, which is being
recognized over the development period of our licensed drug candidates; |
|
|
|
|
royalty payments associated with product sales of Tyzeka®/Sebivo® made by Novartis; and |
|
|
|
|
reimbursement by Novartis for expenses we incurred in connection with the development
and registration of our licensed products and drug candidates, net of certain
qualifying costs incurred by Novartis. |
Collaboration revenue related party was $6.2 million in 2010 as compared to $11.7 million
in 2009. The $5.5 million decrease in license fee revenue was primarily due to $3.7 million
related to the impact of Novartis stock subscription rights and $1.8 million due to adjusting the
expected development period of our licensed drug candidates, which represents the period over which
we recognize license fee revenue.
44
Collaboration revenue recognized under the GSK license agreement was $4.0 million in 2010 as
compared to $0.9 million in 2009. The increase of $3.1 million was primarily due to the recognition
of additional revenue related to the $6.5 million and $20.0 million milestone payments received
from GSK in 2010. A cumulative catch-up of $0.5 million was recognized related to the $6.5 million
milestone payment
in the second quarter of 2010 and $2.2 million related to the $20.0 million milestone payment
in the fourth quarter of 2010.
Cost of Revenues
Cost of revenues were $2.8 million in 2010 as compared to $2.2 million in 2009. The increase
of $0.6 million was primarily a result of higher royalty payments due by us to a third-party
related to the $6.5 million and $20.0 million milestone payments received from GSK in 2010.
Research and Development Expenses
Research and development expenses were $44.5 million in 2010 as compared to $41.9 million in
2009. The increase of $2.6 million was primarily due to $5.9 million of additional expenses in 2010
for a phase IIa clinical trial of IDX184, which was initiated in the fourth quarter of 2009, the
phase I and proof-of-concept clinical studies of IDX320 and a combination phase I clinical study of
IDX184 and IDX320, which were initiated in 2010. These costs were offset by $2.4 million in lower
salaries and personnel related costs, mainly related to reduced headcount as a result of the
restructurings in the United States and Europe.
We expect our research and development expenses for 2011 to be higher than the amount incurred
in 2010 mainly related to our plans to initiate a phase IIb clinical trial for IDX184 in 2011. We
plan to seek a partner that will assist in the further development and commercialization of IDX184,
which would reduce future costs associated with IDX184.
We will continue to devote substantial resources to our research and development activities,
expand our research pipeline and engage in future development activities as we continue to advance
our drug candidates and explore collaborations with other entities that we believe will create
shareholder value.
General and Administrative Expenses
General and administrative expenses were $23.4 million in 2010 as compared to $21.5 million in
2009. The increase of $1.9 million was primarily due to $5.0 million of severance expense and
share-based compensation expense related to Dr. Sommadossis resignation in October 2010. These
costs were offset by $2.8 million lower consulting fees, salaries and personnel related costs,
mainly related to reduced headcount as a result of the restructuring in the United States.
We expect general and administrative expenses in 2011 to be lower than expenses incurred in
2010 mainly due to the absence of the severance expense related to Dr. Sommadossis resignation.
Restructuring Charges
Restructuring charges were $2.2 million in 2010 as compared to $1.5 million in 2009. During
the first quarter of 2010, we initiated a plan to restructure our operations at our research
facility in Montpellier, France to reduce its workforce by approximately 17 positions in connection
with our ongoing cost saving initiatives. In the first quarter of 2010, we recorded charges of $2.2
million for employee severance costs related to the restructuring of our Montpellier facility
together with charges related to an earlier reduction of our United States workforce by 13
positions in January 2010. Of this amount, $2.1 million of the severance costs were paid and the
remaining balance of $0.1 million continued to be accrued as of December 31, 2010.
In June 2009, we closed our lab facility in Cagliari, Italy and eliminated 18 employee
positions as a result of continuing cost saving initiatives. The $1.5 million restructuring charge
recognized in 2009 consisted of $1.2 million of employee severance costs and $0.3 million contract
termination costs associated with closing the lab facility. There was no remaining amount accrued
related to this restructuring as of December 31, 2010.
Other Income, Net
Other income, net was $1.1 million in 2010 which was substantially unchanged as compared to
2009.
Income Tax Benefit (Expense)
Income tax benefit was less than $0.1 million in 2010 which was substantially unchanged as
compared to 2009.
45
Comparison of Years Ended December 31, 2009 and 2008
Revenues
Revenues for the years ended December 31, 2009 and 2008 were as follows:
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|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(In Thousands) |
|
Collaboration revenue related party: |
|
|
|
|
|
|
|
|
License fee revenue |
|
$ |
7,968 |
|
|
$ |
5,561 |
|
Royalty revenue |
|
|
3,704 |
|
|
|
2,885 |
|
Reimbursement of research and development costs |
|
|
45 |
|
|
|
1,369 |
|
|
|
|
|
|
|
|
|
|
|
11,717 |
|
|
|
9,815 |
|
Other revenue: |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
854 |
|
|
|
|
|
Government grants and other revenue |
|
|
45 |
|
|
|
234 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
12,616 |
|
|
$ |
10,049 |
|
|
|
|
|
|
|
|
Collaboration revenue related party was $11.7 million in 2009 as compared to $9.8 million
in 2008. The majority of the increase was due to $2.4 million in additional license fee revenue
recognized, mainly related to the impact of Novartis stock subscription rights, as well as $0.8
million in additional royalty payments associated with product sales of Tyzeka®/Sebivo® as compared
to 2008. These amounts were partially offset by a $1.3 million decrease in the reimbursement of
research and development costs from Novartis.
In 2009, we also recognized $0.9 million of collaboration revenue under the GSK license
agreement.
Cost of Revenues
Cost of revenues were $2.2 million in 2009 as compared to $1.7 million in 2008. The increase
of $0.5 million was primarily a result of higher royalty payments due by us to a third-party based
on net sales of Tyzeka®/Sebivo® made by Novartis.
Research and Development Expenses
Research and development expenses were $41.9 million in 2009 as compared to $53.9 million in
2008. The decrease of $12.0 million was primarily due to $4.3 million in lower expenses related to
the transfer of the development of IDX899 to GSK pursuant to the GSK license agreement, which we
entered into in February 2009. We also had $3.0 million in lower salaries and personnel related
costs, mainly related to reduced headcount as a result of employee attrition in the United States
and Europe as well as the elimination of 18 employee positions associated with the closing of our
lab facility in Cagliari, Italy in June 2009. Additionally, lab operating costs decreased $2.1
million and preclinical expenses decreased $1.6 million due to cost saving initiatives.
General and Administrative Expenses
General and administrative expenses were $21.5 million in 2009 as compared to $27.1 million in
2008. The decrease of $5.6 million was primarily due to $2.3 million in lower consulting fees and
$1.8 million in lower salaries and personnel related costs, mainly related to reduced headcount as
a result of employee attrition in the United States. Additionally, depreciation expense decreased
$0.6 million, which was primarily a result of the recognition of accelerated depreciation in March
2008 for assets that were no longer in use.
Restructuring Charges
Restructuring charges were $1.5 million in 2009 as compared to $0.3 million in 2008. In June
2009, we closed our lab facility in Cagliari, Italy and eliminated 18 employee positions as a
result of continuing cost saving initiatives. The $1.5 million restructuring charge recognized in
2009 consisted of $1.2 million of employee severance costs and $0.3 million of contract termination
costs associated with closing the lab facility. As of December 31, 2009, $1.2 million of severance
costs and $0.1 million of contract termination costs were paid and the remaining balance of $0.2
million continued to be accrued for contract termination costs.
Other Income, Net
Other income, net was $1.3 million in 2009 as compared to $2.8 million in 2008. The majority
of the decrease was due to a lower amount of research and development credits that our French
subsidiary was expected to receive as a result of incurring lower expenses in
2009 as compared to 2008.
46
Income Tax Expense
Income tax expense was less than $0.1 million in 2009 which was substantially unchanged as
compared to 2008.
Liquidity and Capital Resources
Since our inception in 1998, we have financed our operations with proceeds obtained in
connection with license and development arrangements and equity financings. The proceeds include:
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license, milestone, royalty and other payments from Novartis; |
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|
|
license, milestone and stock purchase payments from GSK; |
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|
|
reimbursements from Novartis for costs we have incurred subsequent to May 8, 2003 in connection with the
development of Tyzeka®/Sebivo®, valtorcitabine and valopicitabine; |
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|
|
sales of Tyzeka® in the United States through September 30, 2007; |
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|
|
net proceeds from Sumitomo Pharmaceuticals Co., Ltd., or Sumitomo, for reimbursement of development costs; |
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|
|
|
net proceeds from private placements of our convertible preferred stock; |
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|
net proceeds from public or underwritten offerings in July 2004, October 2005, August 2009 and April 2010; |
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|
|
net proceeds from private placements of our common stock concurrent with our 2004 and 2005 public offerings; and |
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|
proceeds from the exercise of stock options granted pursuant to our equity compensation plans. |
In September 2008, we filed a shelf registration statement with the Securities and Exchange
Commission, or SEC, for an indeterminate number of shares of common stock, up to an aggregate of
$100.0 million, for future issuance. Any financing requiring the issuance of additional shares of
capital stock must first be approved by Novartis for so long as Novartis continues to own at least
19.4% of our voting stock. In May 2009, we received approval from Novartis to issue capital shares
pursuant to financing transactions under our existing shelf registration statement so long as the
issuance of shares did not reduce Novartis interest in Idenix below 43%. Pursuant to this shelf
registration, in August 2009 and in April 2010, we issued approximately 7.3 million and
approximately 6.5 million shares, respectively, of our common stock pursuant to underwritten
offerings and received $21.2 million and $26.3 million in net proceeds, respectively. Novartis did
not participate in either of these offerings and its ownership was diluted from approximately 53%
prior to the August 2009 offering to approximately 43% as of February 15, 2011.
We have incurred losses in each year since our inception and at December 31, 2010, we had an
accumulated deficit of $623.7 million. We expect to incur annual operating losses over the next
several years as we continue to expand our drug discovery and development efforts. We anticipate
initiating a phase IIb 12-week clinical trial of IDX184 in combination with pegylated interferon
and ribavirin in the second half of 2011, which will likely require committing funds in the first
half of 2011. As a result, we may seek additional funding through a combination of public or
private financing, collaborative relationships or other arrangements and are currently seeking a
partner who will assist in the future development and commercialization of IDX184. Such additional
financing may not be available when we need it or may not be available on terms that are favorable
to us. Moreover, any financing requiring the issuance of additional shares of capital stock must
first be approved by Novartis so long as Novartis continues to own at least 19.4% of our voting
stock, as described above. We believe that our current cash and cash equivalents, the expected
royalty payments associated with product sales of
Tyzeka®/Sebivo® and our ability and intent to manage
expenditures will be sufficient to sustain operations for at least 12 months from December 31,
2010. However, if we are unable to obtain adequate financing on a timely basis, we could be
required to delay, reduce or eliminate one or more of our drug development programs, enter into new
collaborative, strategic alliances or licensing arrangements that may not be favorable to us and
reduce the number of our employees. More generally, if we are unable to obtain adequate funding, we
may be required to scale back, suspend or terminate our business operations.
As a result of Dr. Sommadossis resignation on October 28, 2010, he will receive severance
payments of approximately $2.3 million, an option grant of approximately 0.3 million shares and
acceleration of all unvested options. This amount is expected to be paid in 2011.
We had total cash, cash equivalents and marketable securities of $46.1 million and $48.1
million as of December 31, 2010 and 2009, respectively. As of December 31, 2010, we had $46.1
million in cash and cash equivalents. As of December 31, 2009, we had $46.5 million in cash and
cash equivalents and $1.6 million in non-current marketable securities. Our investment policy seeks
to manage these assets to achieve our goals of preserving principal and maintaining adequate
liquidity. Due to the distress in the financial markets over the past few
years certain investments have become less liquid and declined in value. To mitigate the risk
presented by holding illiquid securities, beginning in 2008, we shifted our investments to
instruments that carry less exposure to market volatility and liquidity pressures. As of December
31, 2010, all of our investments were in government agency and treasury money market instruments.
47
Net cash used in operating activities was $28.1 million, $36.0 million and $62.8 million in
2010, 2009 and 2008, respectively. The decrease in cash used in operating activities in 2010
compared to 2009 was primarily due to the receipt of payments from GSK pursuant to the GSK license
agreement. In 2010, we received $26.5 million in milestone payments as compared to $17.0 million in
license fee payments in 2009. The decrease in cash used in operating activities in 2009 compared to
2008 was due primarily to less expenses in 2009 related to the transfer of the development of
IDX899 to GSK and $17.0 million received from GSK pursuant to the GSK license agreement.
Additionally, we incurred less operating expenses in 2009 as compared to 2008 due to reduced
headcount and cost saving initiatives.
Net cash provided by investing activities was $0.7 million, $2.1 million and $55.3 million in
2010, 2009 and 2008, respectively. The decrease in cash provided by investing activities in 2010
and 2009 was due primarily to lower net proceeds from sales and maturities of our marketable
securities as compared to 2008. This was attributable to lower cash balances invested in marketable
securities in 2010 and 2009 due to the use of cash to fund operations.
Net cash provided by financing activities was $26.9 million, $38.3 million and $0.8 million in
2010, 2009 and 2008, respectively. The change in cash provided by financing activities in 2010 was
primarily due to $17.0 million received in proceeds related to the issuance of stock to GSK
pursuant to the stock purchase agreement in March 2009. This amount is offset by $5.1 million in
additional net proceeds we received in 2010 as compared to 2009 from the issuance of our common
stock pursuant to underwritten agreements. The net cash provided by financing activities in 2008
was primarily due to the exercise of stock options by employees.
Contractual Obligations and Commitments
Set forth below is a description of our contractual obligations as of December 31, 2010:
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less Than |
|
|
|
|
|
|
|
|
|
|
After 5 |
|
Contractual Obligations |
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
4-5 Years |
|
|
Years |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
$ |
11,606 |
|
|
$ |
3,133 |
|
|
$ |
5,718 |
|
|
$ |
1,702 |
|
|
$ |
1,053 |
|
Settlement payments and other agreements |
|
|
1,413 |
|
|
|
1,249 |
|
|
|
164 |
|
|
|
|
|
|
|
|
|
Long-term obligations |
|
|
8,478 |
|
|
|
|
|
|
|
1,199 |
|
|
|
|
|
|
|
7,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
21,497 |
|
|
$ |
4,382 |
|
|
$ |
7,081 |
|
|
$ |
1,702 |
|
|
$ |
8,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in the table above is $9.3 million related to a settlement agreement we entered into
in July 2008 with the University of Alabama at Birmingham, or UAB, the University of Alabama at
Birmingham Research Foundation, or UABRF, an affiliate of UAB, and Emory University relating to our
telbivudine technology. Pursuant to this settlement agreement, all contractual disputes relating to
patents covering the use of certain synthetic nucleosides for the treatment of HBV and all
litigation matters relating to patents and patent applications related to the use of
ß-L-2-deoxy-nucleosides for the treatment of HBV assigned to one or more of Idenix, Le Centre
National de la Recherche Scientifique, or CNRS, and the Universite Montpellier II, or the
University of Montpellier, and which cover the use of Tyzeka®/Sebivo®
(telbivudine) for the treatment of HBV have been resolved. Under the terms of the settlement
agreement, we paid UABRF (on behalf of UAB and Emory University) a $4.0 million upfront payment and
will make additional payments to UABRF equal to 20% of all royalty payments received by us from
Novartis based on worldwide sales of telbivudine, subject to minimum payment obligations
aggregating $11.0 million. Our payment obligations under the settlement agreement will expire in
August 2019. The settlement agreement was effective on June 1, 2008 and included mutual releases of
all claims and covenants not to sue among the parties. It also included a release from a
third-party scientist who had claimed to have inventorship rights in certain Idenix/CNRS/University
of Montpellier patents.
In connection with certain of our operating leases, we have two letters of credit with a
commercial bank totaling $1.2 million which expire at varying dates through December 31, 2013.
As of December 31, 2010, we had $3.0 million of other long-term liabilities recorded. These
liabilities and certain potential payment obligations relating to our HBV and HCV product and drug
candidates that are described below are excluded from the contractual obligations table above as we
cannot make a reliable estimate of the period in which the cash payments may be made.
In May 2004, we entered into a settlement agreement with UAB which provides for a milestone
payment of $1.0 million to UAB upon receipt of regulatory approval in the United States to market
and sell certain HCV products invented or discovered by our former chief
executive officer during the period from November 1, 1999 to November 1, 2000. This settlement
agreement also provides that we will pay UAB an amount equal to 0.5% of worldwide net sales of such
HCV products with a minimum sales-based payment equal to $12.0 million. Currently, there are no
such HCV products approved and therefore there was no related liability recorded as of December 31,
2010.
48
We have potential payment obligations under the license agreement with the Universita degli
Studi di Cagliari, or the University of Cagliari, pursuant to which we have the exclusive worldwide
right to make, use and sell certain HCV and HIV technologies. We made certain payments to the
University of Cagliari under these arrangements based on the payments we received from GSK under
the GSK license agreement. We are also liable for certain payments to the University of Cagliari if
we receive license fees or milestone payments with respect to such technology from Novartis, GSK or
another collaborator.
In May 2003, we and Novartis entered into an amended and restated agreement with CNRS and the
University of Montpellier pursuant to which we worked in collaboration with scientists from CNRS
and the University of Montpellier to discover and develop technologies relating to antiviral
substances, including telbivudine. This cooperative agreement expired in December 2006, but we
retain rights to exploit the patents derived from the collaboration. Under the cooperative
agreement, we are obligated to make royalty payments for products derived from such patents.
In March 2003, we entered into a final settlement agreement with Sumitomo under which the
rights to develop and commercialize telbivudine in Japan, China, South Korea and Taiwan previously
granted to Sumitomo were returned to us. This agreement with Sumitomo became effective upon
consummation of our collaboration with Novartis in May 2003. The settlement agreement which we
entered into with Sumitomo provides for a $5.0 million milestone payment to Sumitomo if and when
the first commercial sale of telbivudine occurs in Japan. As part of the development and
commercialization agreement, Novartis will reimburse us for any such payment made to Sumitomo.
In December 2001, we retained the services of Clariant (subsequently acquired by Archimica
Group), a provider of manufacturing services in the specialty chemicals industry, in the form of a
multiproject development and supply agreement. Under the terms of the agreement with Clariant, we
would, on an as needed basis, utilize the Clariant process development and manufacture services
in the development of certain of our drug candidates, including telbivudine. After reviewing
respective bids from each of Novartis and Clariant, the joint manufacturing committee of Idenix and
Novartis decided to proceed with Novartis as the primary manufacturer of telbivudine. In late 2007,
we transferred full responsibility to Novartis for the development, commercialization and
manufacturing of telbivudine. As a result, in January 2008, we exercised our right under the
agreement with Clariant to terminate the relationship effective July 2008. In February 2008,
Clariant asserted that they should have been able to participate in the manufacturing process for
telbivudine as a non-primary supplier and therefore are due an unspecified amount. We do not agree
with Clariants assertion and therefore have not recorded a liability associated with this
potential contingent matter. Clariant has not initiated legal proceedings. If legal proceedings are
initiated, we intend to vigorously defend against such lawsuit.
Off-Balance Sheet Transactions
We currently have no off-balance sheet transactions.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on
our financial statements, which have been prepared in accordance with generally accepted accounting
principles in the United States of America, or GAAP. The preparation of the financial statements
requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments,
including those related to revenue recognition, accrued expenses and share-based compensation. We
base our estimates on historical experience and on various other assumptions that we believe to be
reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying value of assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting policies are more fully described in Note 2 to our consolidated
financial statements included in this Annual Report on Form 10-K for the year ended December 31,
2010. However, we believe that the following critical accounting policies are important to the
understanding and evaluating of our reported financial results.
Revenue Recognition
Revenue is recognized in accordance with SEC Staff Accounting Bulletin No. 101, Revenue
Recognition in Financial Statements, or SAB No. 101, as amended by SEC Staff Accounting Bulletin
No. 104, Revenue Recognition, and, for revenue arrangements entered into after June 30, 2003, in
accordance with the revenue recognition guidance of the Financial Accounting Standards Board, or
FASB. We record revenue provided that there is persuasive evidence that an arrangement exists,
delivery has occurred or services have been rendered, the price is fixed or determinable and
collectability is reasonably assured.
Our revenues are generated primarily through collaborative research, development and/or
commercialization agreements. The terms of
these agreements typically include payments to us for non-refundable license fees, milestones,
collaborative research and development funding and royalties received from our collaboration
partners.
49
Non-Refundable License Fee Payments
Where we have continuing performance obligations under the terms of a collaborative
arrangement, non-refundable license fees are recognized as revenue over the expected development
period as we complete our performance obligations. When our level of effort is relatively constant
over the performance period or no other performance pattern is evident, the revenue is recognized
on a straight-line basis. The determination of the performance period involves judgment on the part
of management. Payments received from collaboration partners for research and development efforts
by us are recognized as revenue over the contract term as the related costs are incurred, net of
any amounts due to the collaboration partner for costs incurred during the period for shared
development costs.
Where we have no continuing involvement or obligations under a collaborative arrangement, we
record non-refundable license fee revenue when we have a contractual right to receive the payment,
in accordance with the terms of the license agreement.
Milestone Payments
Revenues from milestones related to an arrangement under which we have continuing performance
obligations, if deemed substantive, are recognized as revenue upon achievement of the milestone.
Milestones are considered substantive if all of the following conditions are met: a) the milestone
is non-refundable; b) achievement of the milestone was not reasonably assured at the inception of
the arrangement; c) substantive effort is involved to achieve the milestone; and d) the amount of
the milestone appears reasonable in relation to the effort expended. If any of these conditions is
not met, the milestone payment is deferred and recognized as revenue as we complete our performance
obligations.
Where we have no continuing involvement or obligations under a collaborative arrangement, we
record milestones when we receive appropriate notification of achievement of the milestones by the
collaboration partner.
Collaboration Revenue Related Party
In May 2003, we entered into a collaboration with Novartis relating to the worldwide
development and commercialization of our drug candidates. This agreement has several joint
committees in which we and Novartis participate. We participate in these committees as a means to
govern or protect our interests. The committees span the period from early development through
commercialization of drug candidates licensed by Novartis. As a result of applying the provisions
of SAB No. 101, which was the applicable revenue guidance at the time the collaboration was entered
into, our revenue recognition policy attributes revenue to the development period of the drug
candidates licensed under the development and commercialization agreement. We have not attributed
revenue to our involvement in the committees following the commercialization of the licensed
products as we have determined that our participation on the committees as such participation
relates to the commercialization of drug candidates is protective. Our determination is based in
part on the fact that our expertise is, and has been, the discovery and development of drugs for
the treatment of human viral diseases. Novartis, on the other hand, has the considerable
commercialization expertise and infrastructure necessary for the commercialization of such drug
candidates. Accordingly, we believe our obligation post commercialization is inconsequential.
We recognize non-refundable payments received from Novartis over the performance period of our
continuing obligations. In the second quarter of 2010, we adjusted the period over which we
amortize the deferred payments to be through May 2021 based on current judgments related to the
product development timeline of our licensed drug candidates. We review our assessment and judgment
on a quarterly basis with respect to the expected duration of the development period of our
licensed drug candidates. If the estimated performance period changes, we will adjust the periodic
revenue that is being recognized and will record the remaining unrecognized non-refundable payments
over the remaining development period during which our performance obligations will be completed.
Significant judgments and estimates are involved in determining the estimated development period
and different assumptions could yield materially different results.
Upon the grant of options and stock awards under stock incentive plans, with the exception of
the 1998 equity incentive plan, the fair value of our common stock that would be issuable to
Novartis, less the exercise price, if any, payable by the option or award holder, is recorded as a
reduction of the non-refundable payments associated with the Novartis collaboration. The amount is
attributed proportionately between cumulative revenue recognized through the current date and the
remaining amount of deferred revenue. These amounts will be adjusted through the date that Novartis
elects to purchase the shares to maintain its percentage ownership based upon changes in the value
of our common stock and in Novartis percentage ownership. As of December 31, 2010, the aggregate
impact of Novartis stock subscription rights has reduced the non-refundable payments by $18.3
million, which has been recorded as additional paid-in capital. Of this amount, $4.9 million has
been recorded as a reduction of deferred revenue with the remaining amount of $13.4 million as a
reduction of license fee revenue. For the year ended December 31, 2010, the impact of Novartis
stock subscription rights has increased additional paid-in capital by $2.9 million, decreased
deferred revenue by $0.9 million and decreased license fee revenue by $2.0 million.
Royalty revenue consists of revenue earned under our license agreement with Novartis for sales
of Tyzeka®/Sebivo®, which is
recognized when reported from Novartis. Royalty revenue is equal to a percentage of
Tyzeka®/Sebivo® net sales, with such percentage increasing according to specified tiers of net
sales. The royalty percentage varies based on the specified territory and the aggregate dollar
amount of net sales.
50
Other Revenue
In February 2009, we entered into the GSK license agreement and granted GSK an exclusive
worldwide license to develop, manufacture and commercialize our NNRTI compounds, including IDX899,
for the treatment of human diseases, including HIV/AIDS. Under this agreement, in March 2009, we
received a $17.0 million non-refundable license fee payment. In May 2010, we received a $6.5
million milestone payment from GSK for the achievement of an operational preclinical milestone
related to the development of 761. In November 2010, we received a $20.0 million milestone payment
from GSK for the initiation of a phase IIb clinical study of 761. This agreement has performance
obligations, including joint committee participation and GSKs right to license other NNRTI
compounds that we may develop in the future, that we have assessed under the FASB guidance related
to multiple element arrangements. We concluded that this arrangement should be accounted for as a
single unit of accounting and recognized as revenue using the contingency adjusted performance
method. The $43.5 million payments received from GSK were recorded as deferred revenue and are
being recognized as revenue over the life of the agreement, which is estimated to be 17 years. A
cumulative catch-up is recognized for the period from the execution of the license agreement in
March 2009 through the period in which the milestone payments are received. In February 2011, GSK
informed us that the FDA placed 761 on clinical hold. GSK has full responsibility for the
development of 761, including any regulatory interactions.
Deferred Revenue
In March 2003, we entered into a final settlement agreement with Sumitomo under which the
rights to develop and commercialize telbivudine in Japan, China, South Korea and Taiwan previously
granted to Sumitomo were returned to us. This agreement with Sumitomo became effective upon
consummation of our collaboration with Novartis in May 2003. We repurchased these product rights
for $5.0 million. The repurchase of these rights resulted in a $4.6 million reversal of revenue
that we previously recognized under our original arrangements with Sumitomo. We recorded the
remaining amount of $0.4 million as a reduction of deferred revenue. We have also included $4.3
million as deferred revenue, net of current portion in our consolidated balance sheets at December
31, 2010 and 2009 representing amounts received from Sumitomo that we have not included in our
revenue to date. We are required to pay an additional $5.0 million to Sumitomo if and when the
first commercial sale of telbivudine occurs in Japan. This payment will be recorded first as a
reduction of the remaining $4.3 million of deferred revenue, with the excess recorded as an
expense. As part of the development and commercialization agreement, Novartis will reimburse us for
any such payment made to Sumitomo. If regulatory approval is not received for telbivudine in Japan,
we would have no further obligations under the settlement agreement with Sumitomo and, therefore,
the $4.3 million of remaining deferred revenue would be recognized as revenue at that time.
Accrued Expenses
As part of the process of preparing our financial statements, we are required to estimate
accrued expenses. This process involves estimating the level of service performed by third-parties
on our behalf and the associated cost incurred for these services as of each balance sheet date in
our financial statements. Examples of estimated accrued expenses in which subjective judgments may
be required include services provided by contract organizations for preclinical development,
clinical trials and manufacturing of clinical materials. Accruals for amounts due to clinical
research organizations are among our most significant estimates. In connection with these service
fees, our estimates are most affected by our understanding of the status and timing of services
provided relative to the actual level of services incurred by the service providers. The date on
which certain services commence, the level of services performed on or before a given date and the
cost of services is often subject to our judgment. We make these judgments based upon the facts and
circumstances known to us. In the event that we do not identify certain costs that have been
incurred or we underestimate or overestimate the level of services or the costs of such services,
our reported expenses for a reporting period could be overstated or understated. To date, our
estimates have not differed significantly from the actual costs incurred.
Share-Based Compensation
We account for share-based compensation for employees and directors using a fair value based
method that results in expense being recognized in our financial statements. We make assumptions
related to the expected volatility of our stock and the expected term of the awards granted in
order to value and expense our share-based compensation. The expected option term and expected
volatility are determined by examining the expected option term and volatility of our own stock as
well as those of similarly sized biotechnology companies. We review these assumptions periodically.
The amounts recognized for share-based compensation expense could vary depending upon changes in
these assumptions.
Share-based compensation expense is recognized based on awards ultimately expected to vest and
should be reduced for estimated forfeitures. During 2010, 2009 and 2008, because substantially all
of our stock option grants vest monthly, no forfeiture assumption was applied.
For purposes of our consolidated statements of operations, we have allocated share-based
compensation to expense categories based on the nature of the service provided by the recipients of
the stock option grants. We expect to continue to grant options to purchase common stock in the
future.
51
Recent Accounting Pronouncements
In October 2009, the FASB issued Accounting Standard Update, or ASU, No. 2009-13,
Multiple-Deliverable Revenue Arrangements. This ASU eliminates the requirement to establish the
fair value of undelivered products and services and instead provides for separate revenue
recognition based upon managements estimate of the selling price for an undelivered item when
there is no other means to determine the fair value of that undelivered item. This ASU also
eliminates the use of the residual method and instead requires an entity to allocate revenue using
the relative selling price method. Additionally, the guidance expands disclosure requirements with
respect to multiple-deliverable revenue arrangements. This ASU is effective prospectively for
revenue arrangements entered into or materially modified in fiscal years beginning on or after June
15, 2010. Although we are still evaluating the impact of this standard, we do not expect its
adoption to have a material impact on our financial position or the results of our operations. This
standard may impact us in the event we complete future transactions or modify existing
collaborative relationships.
In April 2010, the FASB issued ASU No. 2010-17, Revenue Recognition Milestone Method. This
ASU provides guidance on the criteria that should be met for determining whether the milestone
method of revenue recognition is appropriate. Under the milestone method of revenue recognition,
consideration that is contingent upon achievement of a milestone in its entirety can be recognized
as revenue in the period in which the milestone is achieved only if the milestone meets all
criteria to be considered substantive. This standard provides the criteria to be met for a
milestone to be considered substantive which includes that: a) performance consideration earned by
achieving the milestone be commensurate with either performance to achieve the milestone or the
enhancement of the value of the item delivered as a result of a specific outcome resulting from
performance to achieve the milestone; and b) it relates to past performance and be reasonable
relative to all deliverables and payment terms in the arrangement. This standard is effective on a
prospective basis for milestones achieved in fiscal years beginning on or after June 15, 2010.
Although we are still evaluating the impact of this standard, we do not expect its adoption to have
a material impact on our financial position or the results of our operations.
|
|
|
Item 7A. |
|
Quantitative and Qualitative Disclosure About Market Risk |
Interest Rate Risk
Our exposure to market risk for changes in interest rates relates primarily to our investment
portfolio. Our investment policy seeks to manage our assets to achieve our goals of preserving
principal and maintaining adequate liquidity. The distress in the financial markets over the past
few years has caused certain investments to diminish liquidity and decline in value. Due to the
failed auctions related to our auction rate security and the continued uncertainty in the credit
markets, the market value of our securities may decline further and may prevent us from liquidating
our holdings. To mitigate this risk, beginning in 2008, we began to shift our investments to
instruments that carry less exposure to market volatility and liquidity pressures. As of December
31, 2010, all of our investments were in government agency and treasury money market instruments.
Due to the conservative nature of these instruments, we do not believe that we have a material
exposure to interest rate risk.
Foreign Currency Exchange Rate Risk
Our foreign currency transactions include agreements denominated, wholly or partly, in foreign
currencies, European subsidiaries that are denominated in foreign currencies and royalties earned
based on worldwide product sales of Sebivo® by Novartis. As a result of these foreign currency
transactions, our financial position, results of operations and cash flows can be affected by
market fluctuations in foreign currency exchange rates. We have not entered into any derivative
financial instruments to reduce the risk of fluctuations in currency exchange rates.
|
|
|
Item 8. |
|
Financial Statements and Supplementary Data |
The financial statements required by this item are incorporated by reference to the financial
statements listed in Item 15(a) of Part IV of this Annual Report on Form 10-K.
|
|
|
Item 9. |
|
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure |
None.
52
|
|
|
Item 9A. |
|
Controls and Procedures |
Disclosure Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer and interim chief
financial officer, evaluated the effectiveness of our disclosure controls and procedures as of
December 31, 2010. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934, or Exchange Act, means controls and other
procedures of a company that are designed to ensure that information required to be disclosed by a
company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the SECs rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure
that information required to be disclosed by a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the companys management, including its
principal executive officer and principal financial officer, as appropriate to allow timely
decisions regarding required disclosure. Management recognizes that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure
controls and procedures as of December 31, 2010, our chief executive officer and interim chief
financial officer concluded that, as of such date, our disclosure controls and procedures were
effective at the reasonable assurance level.
Managements Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and
15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of,
our principal executive officer and principal financial officer and effected by our 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 GAAP and
includes those policies and procedures that:
|
|
|
pertain to the maintenance of records that in reasonable detail
accurately and fairly reflect the transactions and dispositions of our
assets; |
|
|
|
|
provide reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in accordance
with GAAP, and that our receipts and expenditures are being made only
in accordance with authorizations of our management and directors; and |
|
|
|
|
provide reasonable assurance regarding prevention or timely detection
of unauthorized acquisition, use or disposition of our assets that
could have a material effect on the financial statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. 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.
Our management assessed the effectiveness of our internal control over financial reporting as
of December 31, 2010. In making this assessment, our management used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated
Framework.
Based on our assessment, management concluded that, as of December 31, 2010, our internal
control over financial reporting was effective based on those criteria.
The effectiveness of our internal control over financial reporting as of December 31, 2010 has
been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as
stated in their report, which is included herein.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended December 31,
2010 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
|
|
|
Item 9B. |
|
Other Information |
None.
53
PART III
Certain information required by Part III of this Form 10-K is omitted because we plan to file
a definitive proxy statement pursuant to Regulation 14A not later than 120 days after the end of
the fiscal year covered by this Annual Report on Form 10-K, and certain information to be included
therein is incorporated herein by reference.
|
|
|
Item 10. |
|
Directors, Executive Officers and Corporate Governance |
The response to this Item is incorporated herein by reference to our Proxy Statement for our
2011 Annual Meeting of Stockholders (the 2011 Proxy Statement) under the captions Proposal 1
Election of Directors, Corporate Governance, Compensation of Directors and Sections 16(a)
Beneficial Ownership Reporting and Compliance.
Codes of Business Conduct
We have adopted a Code of Business Conduct and Ethics that applies to all of our directors,
officers and employees, including our principal executive officer, principal financial officer, and
principal accounting officer or controller, and persons performing similar functions. The Code of
Business Conduct and Ethics is posted on our website, www.idenix.com, and is available in print to
any shareholder upon request to the General Counsel at our headquarter offices at 617-995-9800.
Information regarding any amendments to the Code of Business Conduct and Ethics will also be posted
on our website.
|
|
|
Item 11. |
|
Executive Compensation |
The response to this Item is incorporated herein by reference to our 2011 Proxy Statement
under the captions Compensation of Executive Officers, Compensation Interlocks and Insider
Participation and Compensation Committee Report.
The Compensation Committee Report contained in the Proxy Statement under the caption
Executive Compensation shall not be deemed soliciting material or filed with the SEC or
otherwise subject to the liabilities of Section 18 of the Exchange Act nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended, or the
Securities Act, or the Exchange Act, except to the extent we specifically request that such
information be treated as soliciting material or specifically incorporate such information by
reference into a document filed under the Securities Act or the Exchange Act.
|
|
|
Item 12. |
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
The response to this Item is incorporated herein by reference to our 2011 Proxy Statement
under the captions Stock Ownership of Certain Beneficial Owners and Management and Compensation
of Executive Officers Equity Compensation Plan Information.
|
|
|
Item 13. |
|
Certain Relationships, Related Transactions and Director Independence |
The response to this Item is incorporated herein by reference to our 2011 Proxy Statement
under the captions Certain Relationships and Related Transaction, Employment Agreements and
Corporate Governance Director Independence.
|
|
|
Item 14. |
|
Principal Accountant Fees and Services |
The response to this Item is incorporated herein by reference to our 2011 Proxy Statement
under the captions Audit Fees, Audit-Related Fees, All Other Fees and Pre-Approval
Policies.
54
PART IV
|
|
|
Item 15. |
|
Exhibits and Financial Statement Schedules |
(a)(1) Financial Statements: The financial statements required to be filed as part of this
Annual Report on Form 10-K are as follows:
(a)(2) Financial Statement Schedules. The financial statement schedules have been omitted as
the information required is not applicable or the information is presented in the consolidated
financial statements or the related notes.
(a)(3) Exhibits. The Exhibits have been listed in the Exhibit Index immediately preceding the
Exhibits filed as part of this Annual Report on Form 10-K and incorporated herein by reference.
55
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Idenix Pharmaceuticals, Inc.:
In our opinion, the
accompanying consolidated balance sheets and the related consolidated
statements of operations, of stockholders deficit and comprehensive loss and of cash flows
present
fairly, in all material respects, the financial position of Idenix Pharmaceuticals, Inc. and its
subsidiaries at December 31, 2010 and 2009, and the results of their operations and their cash
flows for each of the three years in the period ended December 31, 2010 in conformity with
accounting principles generally accepted in the United States of America. Also in our opinion, the
Company maintained, in all material respects, effective internal control over financial reporting
as of December 31, 2010, based on criteria established in Internal Control Integrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The
Companys management is responsible for these financial statements, for maintaining effective
internal control over financial reporting and for its assessment of the effectiveness of internal
control over financial reporting, included in Managements Annual Report on Internal Control Over
Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on these
financial statements and on the Companys internal control over financial reporting based on our
integrated 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
audits to obtain reasonable assurance about whether the financial statements are free of material
misstatement and whether effective internal control over financial reporting was maintained in all
material respects. Our audits of the financial statements included examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by management, and evaluating the overall
financial statement presentation. Our audit of internal control over financial reporting included
obtaining an understanding of internal control over financial reporting, assessing the risk that a
material weakness exists, and testing and evaluating the design and operating effectiveness of
internal control based on the assessed risk. Our audits also included performing such other
procedures as we considered necessary in the circumstances. We believe that our audits provide a
reasonable basis for our opinions.
A 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 generally accepted accounting
principles. A companys internal control over financial reporting includes those policies and
procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately
and fairly reflect the transactions and dispositions of the assets of the company; (ii) 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 (iii) 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 its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. 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.
/s/ PRICEWATERHOUSECOOPERS LLP
Boston, Massachusetts
March 7, 2011
56
IDENIX PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE DATA)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
ASSETS
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,115 |
|
|
$ |
46,519 |
|
Restricted cash |
|
|
411 |
|
|
|
411 |
|
Receivables from related party |
|
|
840 |
|
|
|
1,049 |
|
Other receivables |
|
|
|
|
|
|
1,505 |
|
Other current assets |
|
|
2,124 |
|
|
|
2,096 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
49,490 |
|
|
|
51,580 |
|
Intangible asset, net |
|
|
9,843 |
|
|
|
11,069 |
|
Property and equipment, net |
|
|
7,179 |
|
|
|
10,091 |
|
Restricted cash |
|
|
750 |
|
|
|
750 |
|
Marketable securities |
|
|
|
|
|
|
1,584 |
|
Other assets |
|
|
2,622 |
|
|
|
1,576 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
69,884 |
|
|
$ |
76,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,558 |
|
|
$ |
1,941 |
|
Accrued expenses |
|
|
11,472 |
|
|
|
8,779 |
|
Deferred revenue |
|
|
2,623 |
|
|
|
1,025 |
|
Deferred revenue, related party |
|
|
3,036 |
|
|
|
6,155 |
|
Other current liabilities |
|
|
305 |
|
|
|
444 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
19,994 |
|
|
|
18,344 |
|
Other long-term liabilities |
|
|
12,058 |
|
|
|
13,590 |
|
Deferred revenue, net of current portion |
|
|
40,340 |
|
|
|
19,393 |
|
Deferred revenue, related party, net of current portion |
|
|
28,588 |
|
|
|
30,776 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
100,980 |
|
|
|
82,103 |
|
Commitments and contingencies (Note 15) |
|
|
|
|
|
|
|
|
Stockholders deficit: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 125,000,000 shares authorized at
December 31, 2010
and 2009; 73,091,514 and 66,365,976 shares issued and outstanding at
December 31, 2010 and 2009, respectively |
|
|
73 |
|
|
|
66 |
|
Additional paid-in capital |
|
|
591,884 |
|
|
|
555,692 |
|
Accumulated other comprehensive income |
|
|
683 |
|
|
|
970 |
|
Accumulated deficit |
|
|
(623,736 |
) |
|
|
(562,181 |
) |
|
|
|
|
|
|
|
Total stockholders deficit |
|
|
(31,096 |
) |
|
|
(5,453 |
) |
|
|
|
|
|
|
|
Total liabilities and stockholders deficit |
|
$ |
69,884 |
|
|
$ |
76,650 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
57
IDENIX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue related party |
|
$ |
6,231 |
|
|
$ |
11,717 |
|
|
$ |
9,815 |
|
Other revenue |
|
|
3,991 |
|
|
|
899 |
|
|
|
234 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
10,222 |
|
|
|
12,616 |
|
|
|
10,049 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
2,765 |
|
|
|
2,210 |
|
|
|
1,745 |
|
Research and development |
|
|
44,506 |
|
|
|
41,867 |
|
|
|
53,887 |
|
General and administrative |
|
|
23,439 |
|
|
|
21,467 |
|
|
|
27,130 |
|
Restructuring charges |
|
|
2,238 |
|
|
|
1,506 |
|
|
|
297 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
72,948 |
|
|
|
67,050 |
|
|
|
83,059 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(62,726 |
) |
|
|
(54,434 |
) |
|
|
(73,010 |
) |
Other income, net |
|
|
1,131 |
|
|
|
1,266 |
|
|
|
2,848 |
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(61,595 |
) |
|
|
(53,168 |
) |
|
|
(70,162 |
) |
Income tax benefit (expense) |
|
|
40 |
|
|
|
(51 |
) |
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(61,555 |
) |
|
$ |
(53,219 |
) |
|
$ |
(70,206 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.87 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.24 |
) |
Shares used in computing basic and diluted net loss per common share |
|
|
70,715 |
|
|
|
61,498 |
|
|
|
56,403 |
|
The accompanying notes are an integral part of these consolidated financial statements.
58
IDENIX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) AND COMPREHENSIVE LOSS
DECEMBER 31, 2010, 2009 and 2008
(IN THOUSANDS, EXCEPT SHARE DATA)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders |
|
|
Comprehensive |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income |
|
|
Deficit |
|
|
Equity (Deficit) |
|
|
Loss |
|
Balance at December 31, 2007 |
|
|
56,189,467 |
|
|
$ |
56 |
|
|
$ |
506,800 |
|
|
$ |
738 |
|
|
$ |
(438,756 |
) |
|
$ |
68,838 |
|
|
|
|
|
Issuance of common stock upon exercise of
stock options |
|
|
339,067 |
|
|
|
1 |
|
|
|
729 |
|
|
|
|
|
|
|
|
|
|
|
730 |
|
|
|
|
|
Issuance of common stock with related party |
|
|
10,325 |
|
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
35 |
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
5,402 |
|
|
|
|
|
|
|
|
|
|
|
5,402 |
|
|
|
|
|
Antidilution shares contingently issuable to
related party |
|
|
|
|
|
|
|
|
|
|
2,917 |
|
|
|
|
|
|
|
|
|
|
|
2,917 |
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(70,206 |
) |
|
|
(70,206 |
) |
|
$ |
(70,206 |
) |
Net change in unrealized holding loss on
marketable securities, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63 |
|
|
|
|
|
|
|
63 |
|
|
|
63 |
|
Cumulative translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(426 |
) |
|
|
|
|
|
|
(426 |
) |
|
|
(426 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(70,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
56,538,859 |
|
|
$ |
57 |
|
|
$ |
515,883 |
|
|
$ |
375 |
|
|
$ |
(508,962 |
) |
|
$ |
7,353 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock upon exercise of
stock options |
|
|
90,987 |
|
|
|
|
|
|
|
150 |
|
|
|
|
|
|
|
|
|
|
|
150 |
|
|
|
|
|
Issuance of common stock with related party |
|
|
11,466 |
|
|
|
|
|
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
28 |
|
|
|
|
|
Issuance of common stock to GlaxoSmithKline |
|
|
2,475,728 |
|
|
|
2 |
|
|
|
16,998 |
|
|
|
|
|
|
|
|
|
|
|
17,000 |
|
|
|
|
|
Issuance of common stock, net of offering
costs |
|
|
7,248,936 |
|
|
|
7 |
|
|
|
21,163 |
|
|
|
|
|
|
|
|
|
|
|
21,170 |
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
4,614 |
|
|
|
|
|
|
|
|
|
|
|
4,614 |
|
|
|
|
|
Antidilution shares contingently issuable to
related party |
|
|
|
|
|
|
|
|
|
|
(3,144 |
) |
|
|
|
|
|
|
|
|
|
|
(3,144 |
) |
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(53,219 |
) |
|
|
(53,219 |
) |
|
$ |
(53,219 |
) |
Net change in unrealized holding gain on
marketable securities, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
|
|
|
|
|
|
31 |
|
|
|
31 |
|
Cumulative translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
564 |
|
|
|
|
|
|
|
564 |
|
|
|
564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(52,624 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
66,365,976 |
|
|
$ |
66 |
|
|
$ |
555,692 |
|
|
$ |
970 |
|
|
$ |
(562,181 |
) |
|
$ |
(5,453 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
59
IDENIX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) AND COMPREHENSIVE LOSS (CONTINUED)
DECEMBER 31, 2010, 2009 and 2008
(IN THOUSANDS, EXCEPT SHARE DATA)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders |
|
|
Comprehensive |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income |
|
|
Deficit |
|
|
Equity (Deficit) |
|
|
Loss |
|
Issuance of common stock upon exercise of
stock options |
|
|
207,346 |
|
|
|
|
|
|
|
494 |
|
|
|
|
|
|
|
|
|
|
|
494 |
|
|
|
|
|
Issuance of common stock with related party |
|
|
57,520 |
|
|
|
|
|
|
|
145 |
|
|
|
|
|
|
|
|
|
|
|
145 |
|
|
|
|
|
Issuance of common stock, net of offering
costs |
|
|
6,460,672 |
|
|
|
7 |
|
|
|
26,259 |
|
|
|
|
|
|
|
|
|
|
|
26,266 |
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
6,417 |
|
|
|
|
|
|
|
|
|
|
|
6,417 |
|
|
|
|
|
Antidilution shares contingently issuable to
related party |
|
|
|
|
|
|
|
|
|
|
2,877 |
|
|
|
|
|
|
|
|
|
|
|
2,877 |
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,555 |
) |
|
|
(61,555 |
) |
|
$ |
(61,555 |
) |
Cumulative translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(287 |
) |
|
|
|
|
|
|
(287 |
) |
|
|
(287 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(61,842 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010 |
|
|
73,091,514 |
|
|
$ |
73 |
|
|
$ |
591,884 |
|
|
$ |
683 |
|
|
$ |
(623,736 |
) |
|
$ |
(31,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
60
IDENIX PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(61,555 |
) |
|
$ |
(53,219 |
) |
|
$ |
(70,206 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
4,576 |
|
|
|
5,186 |
|
|
|
5,403 |
|
Share-based compensation expense |
|
|
6,417 |
|
|
|
4,614 |
|
|
|
5,402 |
|
Revenue adjustment for contingently issuable shares |
|
|
1,956 |
|
|
|
(1,813 |
) |
|
|
1,714 |
|
Other |
|
|
161 |
|
|
|
295 |
|
|
|
1,166 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Receivables from related party |
|
|
209 |
|
|
|
(155 |
) |
|
|
10,302 |
|
Other receivables |
|
|
1,610 |
|
|
|
3,959 |
|
|
|
(287 |
) |
Other current assets |
|
|
(79 |
) |
|
|
(599 |
) |
|
|
2,001 |
|
Other assets |
|
|
(1,112 |
) |
|
|
(524 |
) |
|
|
(279 |
) |
Accounts payable |
|
|
620 |
|
|
|
(1,927 |
) |
|
|
(1,502 |
) |
Accrued expenses and other current liabilities |
|
|
2,581 |
|
|
|
(980 |
) |
|
|
(7,173 |
) |
Deferred revenue |
|
|
22,545 |
|
|
|
16,146 |
|
|
|
|
|
Deferred revenue, related party |
|
|
(4,387 |
) |
|
|
(6,155 |
) |
|
|
(7,274 |
) |
Other liabilities |
|
|
(1,593 |
) |
|
|
(788 |
) |
|
|
(2,021 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(28,051 |
) |
|
|
(35,960 |
) |
|
|
(62,754 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(727 |
) |
|
|
(671 |
) |
|
|
(2,250 |
) |
Purchases of marketable securities |
|
|
|
|
|
|
|
|
|
|
(15,641 |
) |
Sales and maturities of marketable securities |
|
|
1,476 |
|
|
|
2,722 |
|
|
|
73,211 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
749 |
|
|
|
2,051 |
|
|
|
55,320 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise of common stock options |
|
|
494 |
|
|
|
150 |
|
|
|
730 |
|
Proceeds from issuance of common stock to related party |
|
|
145 |
|
|
|
28 |
|
|
|
35 |
|
Proceeds from issuance of common stock, net of offering costs |
|
|
26,266 |
|
|
|
38,170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
26,905 |
|
|
|
38,348 |
|
|
|
765 |
|
Effect of changes in exchange rates on cash and cash equivalents |
|
|
(7 |
) |
|
|
571 |
|
|
|
(82 |
) |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(404 |
) |
|
|
5,010 |
|
|
|
(6,751 |
) |
Cash and cash equivalents at beginning of year |
|
|
46,519 |
|
|
|
41,509 |
|
|
|
48,260 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
46,115 |
|
|
$ |
46,519 |
|
|
$ |
41,509 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Taxes paid |
|
$ |
25 |
|
|
$ |
57 |
|
|
$ |
132 |
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Change in value of shares of common stock contingently issuable or issued
to related party |
|
|
2,877 |
|
|
|
(3,144 |
) |
|
|
2,917 |
|
The accompanying notes are an integral part of these consolidated financial statements.
61
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. Organization
Idenix Pharmaceuticals, Inc., which we refer to as Idenix, we, us or our, is a
biopharmaceutical company engaged in the discovery and development of drugs for the treatment of
human viral diseases with operations in the United States and Europe. Currently, our primary
research and development focus is on the treatment of hepatitis C virus, or HCV.
In September 2010, the U.S. Food and Drug Administration, or FDA, placed two of our HCV drug
candidates, IDX184 and IDX320, on clinical hold. The hold was imposed due to three serious adverse
events of elevated liver function tests that were detected during post drug exposure safety visits
following the 14-day drug-drug interaction study. We believe the hepatotoxicity observed in this
drug-drug interaction study was caused by IDX320 and therefore discontinued the clinical
development of this drug candidate. In February 2011, the full clinical hold on IDX184 was removed.
The program was placed on partial clinical hold, which allows us to initiate a phase IIb 12-week
clinical trial of IDX184 in combination with pegylated interferon and ribavirin, or Peg-IFN/RBV,
with safety evaluations of the patients that will be shared with the FDA at certain intervals in
the trial. We anticipate initiating this clinical trial in the second half of 2011.
In addition to our strategy of developing drugs for the treatment of HCV, we have also
developed products and drug candidates for the treatment of hepatitis B virus, or HBV, human
immunodeficiency virus type-1, or HIV, and acquired immune deficiency syndrome, or AIDS. We
successfully developed and received worldwide marketing approval for telbivudine (Tyzeka®/Sebivo®),
a drug for the treatment of HBV that we licensed to Novartis Pharma AG, or Novartis. In 2007, we
began receiving royalties from Novartis based on a percentage of net sales of Tyzeka®/Sebivo®. We
also discovered and developed through proof-of-concept clinical testing IDX899, a drug candidate
from the class of compounds known as non-nucleoside reverse transcriptase inhibitors, or NNRTIs,
for the treatment of HIV/AIDS. We licensed our NNRTI compounds, including IDX899, or 761, to
GlaxoSmithKline in February 2009. In October 2009, GlaxoSmithKline assigned this agreement to ViiV
Healthcare Company, an affiliate of GlaxoSmithKline, which we refer to collectively as GSK. In
February 2011, GSK informed us that the FDA placed 761 on clinical hold. GSK has full
responsibility for the development of 761, including any regulatory interactions.
On October 28, 2010, Jean-Pierre Sommadossi, Ph.D. resigned from his positions as chairman of
the board of directors, president and chief executive officer. In connection with Dr. Sommadossis
resignation, he will receive severance payments of approximately $2.3 million, an option grant of
approximately 0.3 million shares and acceleration of all unvested options. Additionally, on October
28, 2010, the board of directors appointed Ronald C. Renaud, Jr., to serve as president and chief
executive officer.
We are subject to risks common to companies in the biopharmaceutical industry including, but
not limited to, the successful development of products, clinical trial uncertainty, regulatory
approval, fluctuations in operating results and financial risks, potential need for additional
funding, protection of proprietary technology and patent risks, compliance with government
regulations, dependence on key personnel and collaboration partners, competition, technological and
medical risks and management of growth.
We have incurred losses in each year since our inception and at December 31, 2010, we had an
accumulated deficit of $623.7 million. We expect to incur annual operating losses over the next
several years as we continue to expand our drug discovery and development efforts. We anticipate
initiating a phase IIb 12-week clinical trial of IDX184 in combination with Peg-IFN/RBV in the
second half of 2011, which will likely require committing funds in the first half of 2011. As a
result, we may seek additional funding through a combination of public or private financing,
collaborative relationships or other arrangements and are currently seeking a partner who will
assist in the future development and commercialization of IDX184. Such additional financing may not
be available when we need it or may not be available on terms that are favorable to us. Moreover,
any financing requiring the issuance of additional shares of capital stock must first be approved
by Novartis so long as Novartis continues to own at least 19.4% of our voting stock. In May 2009,
we received approval from Novartis to issue additional shares pursuant to a financing under our
existing shelf registration so long as the issuance of additional shares did not reduce Novartis
interest in Idenix below 43%. As of February 15, 2011, Novartis owned approximately 43% of our
outstanding common stock. We believe that our current cash and cash equivalents, the expected
royalty payments associated with product sales of
Tyzeka®/Sebivo® and our ability and intent to manage
expenditures will be sufficient to sustain operations for at least 12 months from December 31,
2010. However, if we are unable to obtain adequate financing on a timely basis, we could be
required to delay, reduce or eliminate one or more of our drug development programs, enter into new
collaborative, strategic alliances or licensing arrangements that may not be favorable to us and
reduce the number of our employees. More generally, if we are unable to obtain adequate funding, we
may be required to scale back, suspend or terminate our business operations.
62
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
2. Summary of Significant Accounting Policies
Significant accounting policies applied by us in the preparation of our consolidated financial
statements were as follows:
Principles of Consolidation
The accompanying consolidated financial statements reflect the operations of Idenix and our
wholly owned subsidiaries. All
intercompany accounts and transactions have been eliminated in consolidation.
We evaluated all events or transactions that occurred after December 31, 2010.
Certain amounts in prior years consolidated financial statements have been
reclassified to conform to the current presentation. The
reclassifications had no effect on the reported net loss.
Recent Accounting Pronouncements
In October 2009, the Financial Accounting Standards Board, or FASB, issued Accounting Standard
Update, or ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU No. 2009-13. This
ASU eliminates the requirement to establish the fair value of undelivered products and services and
instead provides for separate revenue recognition based upon managements estimate of the selling
price for an undelivered item when there is no other means to determine the fair value of that
undelivered item. This ASU also eliminates the use of the residual method and instead requires an
entity to allocate revenue using the relative selling price method. Additionally, the guidance
expands disclosure requirements with respect to multiple-deliverable revenue arrangements. This ASU
is effective prospectively for revenue arrangements entered into or materially modified in fiscal
years beginning on or after June 15, 2010. Although we are still evaluating the impact of this
standard, we do not expect its adoption to have a material impact on our financial position or the
results of our operations. This standard may impact us in the event we complete future transactions
or modify existing collaborative relationships.
In April 2010, the FASB issued ASU No. 2010-17, Revenue Recognition Milestone Method. This
ASU provides guidance on the criteria that should be met for determining whether the milestone
method of revenue recognition is appropriate. Under the milestone method of revenue recognition,
consideration that is contingent upon achievement of a milestone in its entirety can be recognized
as revenue in the period in which the milestone is achieved only if the milestone meets all
criteria to be considered substantive. This standard provides the criteria to be met for a
milestone to be considered substantive which includes that: a) performance consideration earned by
achieving the milestone be commensurate with either performance to achieve the milestone or the
enhancement of the value of the item delivered as a result of a specific outcome resulting from
performance to achieve the milestone; and b) it relates to past performance and be reasonable
relative to all deliverables and payment terms in the arrangement. This standard is effective on a
prospective basis for milestones achieved in fiscal years beginning on or after June 15, 2010.
Although we are still evaluating the impact of this standard, we do not expect its adoption to have
a material impact on our financial position or the results of our operations.
Use of Estimates and Assumptions
The preparation of consolidated financial statements in accordance with generally accepted
accounting principles requires management to make estimates and judgments that may affect the
reported amounts of assets, liabilities, revenues and expenses, and related disclosures of
contingent assets and liabilities. On an on-going basis, we evaluate our estimates, judgments and
methodologies, including those related to revenue recognition, our collaborative relationships,
clinical trial expenses, impairment and amortization of long-lived assets including intangible
assets, share-based compensation, income taxes including the valuation allowance for deferred tax
assets, contingencies, litigation and restructuring charges. We base our estimates on historical
experience and on various other assumptions that are believed to be reasonable, the results of
which form the basis for making judgments about the carrying values of assets and liabilities.
Actual results may differ from these estimates under different assumptions or conditions.
Cash and Cash Equivalents
We consider all highly liquid investments purchased with a maturity date of 90 days or less at
the date of purchase to be cash equivalents.
In connection with certain of our operating lease commitments (Note 15), we issued letters of
credit collateralized by cash deposits that are classified as restricted cash on the consolidated
balance sheets. Restricted cash amounts have been classified as current or non-current based on the
expected release date of the restrictions.
Concentration of Credit Risk
Financial instruments that potentially subject us to concentrations of credit risk primarily
consist of cash and cash equivalents, marketable securities and receivables from related party. We
invest our excess cash, cash equivalents and marketable securities in interest bearing accounts at
major United States financial institutions. Management mitigates credit risk by limiting the
investment type and maturity to securities that preserve capital, maintain liquidity and have a
high credit quality.
At December 31, 2010 and 2009, all of our receivables from related party were due from
Novartis. Included in the receivables from related party balances were royalties associated with
the sales of Tyzeka®/Sebivo® under the collaborative agreement with Novartis in the normal course
of business. Revenue from Novartis represented the majority of our revenues for the years ended
December 31, 2010, 2009 and 2008.
63
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Marketable Securities
We invest our excess cash balances in short-term and long-term marketable debt securities. We
classify our marketable securities with remaining final maturities of 12 months or less based on
the purchase date as current marketable securities, exclusive of those categorized as cash
equivalents. We classify our marketable securities with remaining final maturities greater than 12
months as non-current marketable securities to the extent we do not expect to be required to
liquidate them before maturity. We classify all of our marketable debt securities as
available-for-sale. We report available-for-sale investments at fair value as of each balance sheet
date and include any unrealized gains and, to the extent deemed temporary, unrealized losses in
other comprehensive loss. Realized gains and losses are determined using the specific
identification method and are included in other income, net in our consolidated financial
statements.
Investments are considered to be impaired when a decline in fair value below cost basis is
determined to be other-than-temporary. We evaluate whether a decline in fair value below cost basis
is other-than-temporary using available evidence regarding our investments. In the event that the
cost basis of a security significantly exceeds its fair value, we evaluate, among other factors,
the duration of the period that, and extent to which, the fair value is less than cost basis, the
financial health of and business outlook for the issuer, including industry and sector performance,
and operational and financing cash flow factors, overall market conditions and trends, our intent
to sell the investment and if it is more likely than not that we would be required to sell the
investment before its anticipated recovery. Once a decline in fair value is determined to be
other-than-temporary, a write-down is recorded in the consolidated statement of operations and a
new cost basis in the security is established.
Fair Value Measurements
Our assets and liabilities that are measured at fair value on a recurring basis as of December
31, 2010 and December 31, 2009 are measured in accordance with FASB guidance. Fair values
determined by Level 1 inputs utilize observable data such as quoted prices in active markets. Fair
values determined by Level 2 inputs utilize data points other than quoted prices in active markets
that are observable either directly or indirectly. Fair values determined by Level 3 inputs utilize
unobservable data points in which there is little or no market data, which require the reporting
entity to develop its own assumptions.
Our money market investments have calculated net asset values and are therefore classified as
Level 2. We had one security classified as Level 3 as of December 31, 2009, which was an auction
rate security that did not actively trade. We determined the fair value of the security based on a
discounted cash flow model which incorporated a discount period, coupon rate, liquidity discount
and coupon history. We also considered in determining the fair value the rating of the security by
investment rating agencies and whether or not the security was backed by the United States
government. This auction rate security was sold in June 2010.
Intangible Asset
Our intangible asset relates to a settlement agreement entered into by and among us along with
our former chief executive officer in his individual capacity, the Universite Montpellier II, or
the University of Montpellier, Le Centre National de la Recherche Scientifique, or CNRS, the Board
of Trustees of the University of Alabama on behalf of the University of Alabama at Birmingham, or
UAB, the University of Alabama at Birmingham Research Foundation, or UABRF, and Emory University as
described more fully in Note 15. The settlement agreement, entered into in July 2008 and effective
as of June 1, 2008, includes a full release of all claims, contractual or otherwise, by the
parties.
Pursuant to the settlement agreement, we paid UABRF (on behalf of UAB and Emory University) a
$4.0 million upfront payment and will make additional payments to UABRF equal to 20% of all royalty
payments received by us from Novartis based on worldwide sales of telbivudine, subject to minimum
payment obligations aggregating $11.0 million. We are amortizing $15.0 million related to this
settlement payment to UAB and related entities over the life of the agreement, or August 2019.
The following table is a rollforward of our intangible asset as shown in our consolidated
balance sheets:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
Beginning balance |
|
$ |
11,069 |
|
|
$ |
12,387 |
|
Amortization expense |
|
|
(1,226 |
) |
|
|
(1,318 |
) |
|
|
|
|
|
|
|
Ending balance |
|
$ |
9,843 |
|
|
$ |
11,069 |
|
|
|
|
|
|
|
|
64
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
As of December 31, 2010, accumulated amortization was $5.2 million. Amortization expense
for this asset is anticipated to be $1.1
million per year through December 31, 2015 and $4.3 million through the remaining term of the
expected economic benefit of the asset.
Property and Equipment
Property and equipment are recorded at cost. Depreciation is calculated using the
straight-line method over the estimated useful life of each of the assets, except for leasehold
improvements which are amortized using the straight-line method over the shorter of the asset life
or the related lease term. Upon disposal of property and equipment, the related cost and
accumulated depreciation is removed from the asset accounts and any resulting gain or loss is
included in the consolidated statements of operations. Repair and maintenance costs are expensed as
incurred.
Impairment of Long-Lived Assets
We evaluate the recoverability of our property and equipment and other long-lived assets when
circumstances indicate that an event of impairment may have occurred in accordance with FASB
guidance. Determination of recoverability is based on an estimate of undiscounted future cash flows
resulting from the use of the asset and its eventual disposition. In the event that such cash flows
are not expected to be sufficient to recover the carrying amount of the assets, the assets are
written-down to their estimated fair values. Long-lived assets and certain identifiable intangible
assets to be disposed of are reported at the lower of carrying amount or fair value less cost to
sell.
No impairment charges were recognized for the years ended December 31, 2010, 2009 and 2008.
Revenue Recognition
Revenue is recognized in accordance with the Securities and Exchange Commission, or SEC, Staff
Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, or SAB No. 101, as
amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition, and, for revenue
arrangements entered into after June 30, 2003, in accordance with the revenue recognition guidance
of the FASB. We record revenue provided that there is persuasive evidence that an arrangement
exists, delivery has occurred or services have been rendered, the price is fixed or determinable
and collectability is reasonably assured.
Our revenues are generated primarily through collaborative research, development and/or
commercialization agreements. The terms of these agreements typically include payments to us for
non-refundable license fees, milestones, collaborative research and development funding and
royalties received from our collaboration partners.
Non-Refundable License Fee Payments
Where we have continuing performance obligations under the terms of a collaborative
arrangement, non-refundable license fees are recognized as revenue over the expected development
period as we complete our performance obligations. When our level of effort is relatively constant
over the performance period or no other performance pattern is evident, the revenue is recognized
on a straight-line basis. The determination of the performance period involves judgment on the part
of management. Payments received from collaboration partners for research and development efforts
by us are recognized as revenue over the contract term as the related costs are incurred, net of
any amounts due to the collaboration partner for costs incurred during the period for shared
development costs.
Where we have no continuing involvement or obligations under a collaborative arrangement, we
record non-refundable license fee revenue when we have a contractual right to receive the payment,
in accordance with the terms of the license agreement.
Milestone Payments
Revenues from milestones related to an arrangement under which we have continuing performance
obligations, if deemed substantive, are recognized as revenue upon achievement of the milestone.
Milestones are considered substantive if all of the following conditions are met: a) the milestone
is non-refundable; b) achievement of the milestone was not reasonably assured at the inception of
the arrangement; c) substantive effort is involved to achieve the milestone; and d) the amount of
the milestone appears reasonable in relation to the effort expended. If any of these conditions is
not met, the milestone payment is deferred and recognized as revenue as we complete our performance
obligations.
Where we have no continuing involvement or obligations under a collaborative arrangement, we
record milestone revenue when we receive appropriate notification of achievement of the milestones
by the collaboration partner.
65
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Collaboration Revenue Related Party
We entered into a collaboration with Novartis relating to the worldwide development and
commercialization of our drug candidates in May 2003, which we refer to as the development and
commercialization agreement. Under this arrangement, we have received non-refundable license fees,
milestones, collaborative research and development funding and royalties. This arrangement has
several joint committees in which we and Novartis participate. We participate in these committees
as a means to govern or protect our interests. The committees span the period from early
development through commercialization of drug candidates licensed by Novartis. As a result of
applying the provisions of SAB No. 101, which was the applicable revenue guidance at the time the
collaboration was entered into, our revenue recognition policy attributes revenue to the
development period of the drug candidates licensed under the development and commercialization
agreement. We have not attributed revenue to our involvement in the committees following the
commercialization of the licensed products as we have determined that our participation on the
committees as such participation relates to the commercialization of drug candidates is protective.
Our determination is based in part on the fact that our expertise is, and has been, the discovery
and development of drugs for the treatment of human viral diseases. Novartis, on the other hand,
has the considerable commercialization expertise and infrastructure necessary for the
commercialization of such drug candidates. Accordingly, we believe our obligation post
commercialization is inconsequential.
We recognize non-refundable payments over the performance period of our continuing
obligations. This period is estimated based on current judgments related to the product development
timeline of our licensed drug candidates and is currently estimated to be through May 2021. This
policy is described more fully in Note 3.
Royalty revenue consists of revenue earned under our license agreement with Novartis for sales
of Tyzeka®/Sebivo®, which is recognized when reported from Novartis. Royalty revenue is equal to a
percentage of Tyzeka®/Sebivo® net sales, with such percentage increasing according to specified
tiers of net sales. The royalty percentage varies based on the specified territory and the
aggregate dollar amount of net sales.
Other Revenue
In February 2009, we entered into a license agreement with GSK, which we refer to as the GSK
license agreement. Under the GSK license agreement, we granted GSK an exclusive worldwide license
to develop, manufacture and commercialize our NNRTI, compounds, including IDX899, for the treatment
of human diseases, including HIV/AIDS. Under this agreement, in March 2009, we received a $17.0
million non-refundable license fee payment. In May 2010, we received a $6.5 million milestone
payment from GSK for the achievement of an operational preclinical milestone related to the
development of 761. In November 2010, we received a $20.0 million milestone payment from GSK for
the initiation of a phase IIb clinical study of 761. This agreement has performance obligations,
including joint committee participation and GSKs right to license other NNRTI compounds that we
may develop in the future, that we have assessed under the FASB guidance related to multiple
element arrangements, prior to the implementation of ASU No. 2009-13. We concluded that this
arrangement should be accounted for as a single unit of accounting and recognized using the
contingency adjusted performance method. The $43.5 million payments received from GSK were recorded
as deferred revenue and are being recognized as revenue over the life of the agreement, which is
estimated to be 17 years. A cumulative catch-up is recognized for the period from the execution of
the license agreement in March 2009 through the period in which the milestone payments are
received. In February 2011, GSK informed us that the FDA placed 761 on clinical hold. GSK has full
responsibility for the development of 761, including any regulatory interactions.
Government research grants that provide for payments to us for work performed are recognized
as revenue when the related expense is incurred and we have obtained governmental approval to use
the grant funds for these expenses.
Deferred Revenue
In March 2003, we entered into a final settlement agreement with Sumitomo Pharmaceuticals Co.,
Ltd., or Sumitomo, under which the rights to develop and commercialize telbivudine in Japan, China,
South Korea and Taiwan previously granted to Sumitomo were returned to us. This agreement with
Sumitomo became effective upon consummation of our collaboration with Novartis in May 2003. We
repurchased these product rights for $5.0 million. The repurchase of these rights resulted in a
$4.6 million reversal of revenue that we previously recognized under our original arrangements with
Sumitomo. We recorded the remaining amount of $0.4 million as a reduction of deferred revenue. We
have also included $4.3 million as deferred revenue, net of current portion in our consolidated
balance sheets at December 31, 2010 and 2009 representing amounts received from Sumitomo that we
have not included in our revenue to date. We are required to pay an additional $5.0 million to
Sumitomo if and when the first commercial sale of telbivudine occurs in Japan. This payment will be
recorded first as a reduction of the remaining $4.3 million of deferred revenue, with the excess
recorded as an expense. As part of the development and commercialization agreement, Novartis will
reimburse us for any such payment made to Sumitomo. If regulatory approval is not received for
telbivudine in Japan, we would have no further obligations under the settlement agreement with
Sumitomo and, therefore, the $4.3 million of remaining deferred revenue would be recognized as
revenue at that time.
66
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Deferred Expenses
We have entered into cooperative agreements in which we have co-developed or acquired licenses
for certain of our antiviral technology from third-parties. These cooperative agreements generally
require royalty or other payments to be paid by us to the co-developers or licensors when we
out-license rights to or commercialize these certain technologies to our collaboration partners.
These payments to the co-developers or licensors are deferred and are recognized as expense over
the same period that we recognize the related revenue under our collaborative arrangements. These
amounts are recognized as other assets in our consolidated balance sheets.
Research and Development Expenses
All costs associated with internal research and development and external research and
development services, including preclinical and clinical trial studies are expensed as incurred.
Research and development expenses include costs for salaries, employee benefits, subcontractors,
facility related expenses, depreciation, license fees and share-based compensation.
Patents
All costs to secure and defend patents are expensed as incurred.
Share-Based Compensation
We recognize share-based compensation for employees and directors using a fair value based
method that results in expense being recognized in our consolidated financial statements.
Foreign Currency
The functional currencies of our foreign subsidiaries are the local currency or the U.S.
dollar. When the functional currency of the foreign subsidiary is the local currency, assets and
liabilities of the foreign subsidiary are translated into U.S. dollars at the rates of exchange in
effect at the end of the accounting period. Income and expense items are translated at the average
exchange rates for the period. Net gains and losses resulting from foreign currency translation are
included in other comprehensive loss which is a separate component of stockholders deficit. When
the functional currency of the foreign subsidiary is the U.S. dollar, a combination of current and
historical exchange rates are used in remeasuring the local currency transactions of the foreign
subsidiary. Nonmonetary assets and liabilities, including equity, are remeasured using historical
exchange rates. Monetary assets and liabilities are remeasured at current exchange rates. Income
and expense amounts are remeasured using the average exchange rate for the period. Net realized
gains and losses from foreign currency transactions are included in the consolidated statements of
operations. Gains and losses resulting from foreign currency remeasurements are included in the
consolidated statements of operations.
Income Taxes
Deferred tax assets and liabilities are recognized based on the expected future tax
consequences, using current tax rates, of temporary differences between the financial statement
carrying amounts and the income tax basis of assets and liabilities. A valuation allowance is
applied against any net deferred tax asset if, based on the weighted available evidence, it is more
likely than not that some or all of the deferred tax assets will not be realized.
For uncertain tax positions that meet a more likely than not threshold, we recognize the
benefit of uncertain tax positions in our consolidated financial statements.
Comprehensive Loss
Comprehensive loss is comprised of net loss and certain changes in stockholders deficit that
are excluded from net loss. We include foreign currency translation adjustments for subsidiaries in
which the functional currency is not the U.S. dollar and unrealized gains and losses on marketable
securities in other comprehensive loss. The consolidated statements of stockholders deficit and
comprehensive loss reflect total comprehensive loss for the years ended December 31, 2010, 2009 and
2008.
Net Loss per Common Share
Basic net loss per common share is computed by dividing net loss available to common
stockholders by the weighted average number of common shares outstanding during the period. Diluted
net loss per common share is computed by dividing net loss available to common stockholders by the
weighted average number of common shares and other potential common shares then outstanding.
Potential common shares consist of common shares issuable upon the assumed exercise of outstanding
stock options (using the treasury stock method), issuance of contingently issuable shares subject
to Novartis stock subscription rights (Note 3) and restricted stock awards.
67
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Segment Reporting
Our management, which uses consolidated financial information in determining how to allocate
resources and assess performance, has determined that it operates in only one reportable segment.
3. Novartis Relationship
Overview
In May 2003, we entered into a collaboration with Novartis relating to the worldwide
development and commercialization of our drug candidates. In May 2003, Novartis also purchased
approximately 54% of our common stock. Since this date, Novartis has had the ability to exercise
control over our strategic direction, research and development activities and other material
business decisions.
Pursuant to the development and commercialization agreement, we have granted Novartis the
option to license any of our development-stage drug candidates, so long as Novartis maintains at
least 40% ownership of our common stock. If Novartis exercises this option, financial terms will be
based upon certain contractual obligations and future negotiations. Novartis may exercise this
option generally after demonstration of activity and safety in a proof-of-concept clinical trial.
If Novartis licenses a drug candidate, it is obligated to fund a portion of the development
expenses that we incur in accordance with development plans agreed upon by us and Novartis. Under
the development and commercialization agreement, we have granted Novartis an exclusive worldwide
license to market and sell drug candidates that Novartis chooses to license from us. The
commercialization rights under the development and commercialization agreement also include our
right to co-promote or co-market all licensed products in the United States, United Kingdom,
France, Germany, Italy and Spain. Under the development and commercialization agreement, we granted
Novartis an exclusive worldwide license to market and sell Tyzeka®/Sebivo®, valtorcitabine and
valopicitabine.
In 2003, Novartis licensed telbivudine from us under the development and commercialization
agreement. In September 2007, we entered into an amendment to the development and commercialization
agreement, which we refer to as the 2007 amendment. Pursuant to the 2007 amendment, we
transferred to Novartis our worldwide development, commercialization and manufacturing rights and
obligations, including ongoing related expenses to telbivudine (Tyzeka®/Sebivo®). We do not expect
to receive any additional regulatory milestones for telbivudine. In October 2007, we began
receiving royalty payments equal to a percentage of net sales of Tyzeka®/Sebivo®, with such
percentage increasing according to specified tiers of net sales. The royalty percentage varies
based on the specified territory and the aggregate dollar amount of net sales. We recognized $3.8
million, $3.7 million and $2.9 million as royalty revenue from Novartis sales of Tyzeka®/Sebivo®
during the years ended December 31, 2010, 2009 and 2008, respectively.
In October 2009, Novartis waived its right to license IDX184, a nucleotide prodrug for the
treatment of HCV. As a result, we retain the worldwide rights to develop, manufacture,
commercialize and license IDX184. We are currently seeking a partner who will assist in the future
development and commercialization of this drug candidate.
To date, we have received $117.2 million of non-refundable payments from Novartis that have
been recorded as deferred revenue. The $117.2 million received from Novartis consisted of a $25.0
million license fee for valopicitabine, a $75.0 million license fee for telbivudine
(Tyzeka®/Sebivo®) and valtorcitabine, offset by $0.1 million in interest costs, a $5.0 million
reimbursement for reacquiring product rights from Sumitomo to develop and commercialize Sebivo® in
certain markets in Asia, $2.3 million in reimbursement costs associated with the development of
valopicitabine prior to Novartis licensing valopicitabine and a $10.0 million milestone payment for
the regulatory approval of Sebivo® in the European Union. These payments are being recognized over
the development period of the licensed drug candidates, which represents the period of our
continuing obligations. In the second quarter of 2010, we adjusted the period over which we
amortize the deferred payments to be through May 2021 based on current judgements related to the
product development timeline of our licensed drug candidates. We review our assessment and judgment
on a quarterly basis with respect to the expected duration of the development period of our
licensed drug candidates. If the estimated performance period changes, we will adjust the periodic
revenue that is being recognized and will record the remaining unrecognized non-refundable payments
over the remaining development period during which our performance obligations will be completed.
Significant judgments and estimates are involved in determining the estimated development period
and different assumptions could yield materially different results. Related to the deferred
revenue, we recognized $4.4 million, $6.2 million and $7.3 million as revenue during the years
ended December 31, 2010, 2009 and 2008, respectively. These amounts are impacted by Novartis stock
subscription rights described below.
As mentioned above, in addition to the collaboration, in May 2003, Novartis purchased
approximately 54% of our outstanding capital stock from our then existing stockholders. The
stockholders received $255.0 million in cash from Novartis with an additional aggregate amount of
up to $357.0 million contingently payable to these stockholders if we achieve predetermined
development milestones relating to specific HCV drug candidates. As of February 15, 2010, Novartis
owned approximately 43% of our outstanding stock.
68
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Stockholders Agreement
In connection with Novartis purchase of stock from our stockholders, we, Novartis and
substantially all of our stockholders at that time entered into a stockholders agreement, which we
refer to as the stockholders agreement. The stockholders agreement was amended and restated in
2004 in connection with our initial public offering of our common stock. The stockholders
agreement provides, among other things, that we will use our reasonable best efforts to nominate
for election as directors at least two designees of Novartis for so long as Novartis and its
affiliates own at least 35% of our voting stock and at least one designee of Novartis for so long
as Novartis and its affiliates own at least 19.4% of our voting stock. As long as Novartis and its
affiliates continue to own at least 19.4% of our voting stock, Novartis will have approval rights
over a number of corporate actions that we may take, including the authorization or issuance of
additional shares of capital stock and significant acquisitions and dispositions.
Novartis Stock Subscription Rights
Under our stock purchase agreement with Novartis, which we refer to as the stock purchase
agreement, Novartis has the right to purchase, at par value of $0.001 per share, such number of
shares as is required to maintain its percentage ownership of our voting stock if we issue shares
of capital stock in connection with the acquisition or in-licensing of technology through the
issuance of up to 5% of our stock in any 24-month period. These purchase rights of Novartis remain
in effect until the earlier of: a) the date that Novartis and its affiliates own less than 19.4% of
our voting stock; or b) the date that Novartis becomes obligated to make the additional contingent
payments of $357.0 million to holders of our stock who sold shares to Novartis on May 8, 2003.
In addition to the right to purchase shares of our stock at par value as described above, if
we issue any shares of our capital stock, other than in certain situations, Novartis has the right
to purchase such number of shares required to maintain its percentage ownership of our voting stock
for the same consideration per share paid by others acquiring our stock. In September 2008, we
filed a shelf registration statement with the SEC for an indeterminate number of shares of common
stock, up to an aggregate of $100.0 million, for future issuance. Any financing requiring the
issuance of additional shares of capital stock must first be approved by Novartis so long as
Novartis continues to own at least 19.4% of our voting stock. In May 2009, we received approval
from Novartis to issue capital shares pursuant to a financing under our existing shelf registration
statement so long as the issuance of shares did not reduce Novartis interest in Idenix below 43%.
Pursuant to this shelf registration, in August 2009 and in April 2010, we issued approximately 7.3
million and approximately 6.5 million shares, respectively, of our common stock pursuant to
underwritten offerings and received $21.2 million and $26.3 million in net proceeds, respectively.
Novartis did not participate in either of these offerings and its ownership was diluted from
approximately 53% prior to the August 2009 offering to approximately 43% as of February 15, 2011.
In connection with the closing of our initial public offering in July 2004, Novartis
terminated a common stock subscription right with respect to approximately 1.4 million shares of
common stock issuable by us as a result of the exercise of stock options granted after May 8, 2003
pursuant to the 1998 equity incentive plan, as amended, or the 1998 plan. In exchange for Novartis
termination of such right, we issued 1.1 million shares of common stock to Novartis for a purchase
price of $0.001 per share. The fair value of these shares was determined to be $15.4 million at the
time of issuance. As a result of the issuance of these shares, Novartis rights to purchase
additional shares as a result of future option grants and stock issuances under the 1998 plan were
terminated and no additional adjustments to revenue and deferred revenue will be required. Prior to
the termination of the stock subscription rights under the 1998 plan, as we granted options that
were subject to this stock subscription right, the fair value of our common stock that would be
issuable to Novartis, less par value, was recorded as an adjustment of the non-refundable payments
received from Novartis. We remain subject to potential revenue adjustments with respect to grants
of options and stock awards under our stock incentive plans other than the 1998 plan.
Upon the grant of options and stock awards under stock incentive plans, with the exception of
the 1998 plan, the fair value of our common stock that would be issuable to Novartis, less the
exercise price, if any payable by the option or award holder, is recorded as a reduction of the
non-refundable payments associated with the Novartis collaboration. The amount is attributed
proportionately between cumulative revenue recognized through the current date and the remaining
amount of deferred revenue. These amounts will be adjusted through the date that Novartis elects to
purchase the shares to maintain its percentage ownership based upon changes in the value of our
common stock and in Novartis percentage ownership.
As of December 31, 2010, the aggregate impact of Novartis stock subscription rights has
reduced the non-refundable payments by $18.3 million, which has been recorded as additional paid-in
capital. Of this amount, $4.9 million has been recorded as a reduction of deferred revenue with the
remaining amount of $13.4 million as a reduction of license fee revenue. For the year ended
December 31, 2010, the impact of Novartis stock subscription rights has increased additional
paid-in capital by $2.9 million, decreased deferred revenue by $0.9 million and decreased license
fee revenue by $2.0 million. For the year ended December 31, 2009, the impact of Novartis stock
subscription rights has reduced additional paid-in capital by $3.1 million, increased deferred
revenue by $1.3 million and increased license fee revenue by $1.8 million. For the year ended
December 31, 2008, the impact of Novartis stock subscription rights has increased additional
paid-in capital by $2.9 million, reduced deferred revenue by $1.2 million and reduced license fee
revenue by $1.7 million.
69
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Manufacturing and Supply Agreement
Under the master manufacturing and supply agreement, dated May 8, 2003, with Novartis, which
we refer to as the manufacturing and supply agreement, we appointed Novartis to manufacture or
have manufactured the clinical supply of the active pharmaceutical ingredient, or API, for each
drug candidate licensed under the development and commercialization agreement and certain other
drug candidates. The cost of the clinical supply will be treated as a development expense,
allocated between us and Novartis in accordance with the agreement. We have the ability to appoint
Novartis or a third-party to manufacture the commercial supply of the API based on a competitive
bid process under which Novartis has the right to match the best third-party bid. Novartis will
perform the finishing and packaging of the API into the final form for sale.
Product Sales Arrangement
In connection with the drug candidates that Novartis licenses from us, with the exception of
Tyzeka®/Sebivo®, we have retained the right to co-promote or co-market in the United States, United
Kingdom, France, Germany, Italy and Spain. In the United States, we would act as the lead
commercial party and record revenue from product sales and share equally the net benefit from
co-promotion from the date of product launch. In the United Kingdom, France, Germany, Italy and
Spain, Novartis would act as the lead commercial party, record revenue from product sales and would
share with us the net benefit from co-promotion and co-marketing. The net benefit is defined as net
product sales minus related cost of sales. The amount of the net benefit that would be shared with
us would start at 15% for the first 12-month period following the date of launch, increasing to 30%
for the second 12-month period following the date of launch and 50% thereafter. In other countries,
we would effectively sell products to Novartis for their further sale to third-parties. Novartis
would pay us for such products at a price that is determined under the terms of our manufacturing
and supply agreement with Novartis and we would receive a royalty payment from Novartis on net
product sales.
4. Net Loss per Common Share
The following sets forth the computation of basic and diluted net loss per common share:
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Years Ended December 31, |
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2010 |
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2009 |
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2008 |
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(In Thousands, Except per Share Data) |
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Basic and diluted net loss per common share: |
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Net loss |
|
$ |
(61,555 |
) |
|
$ |
(53,219 |
) |
|
$ |
(70,206 |
) |
Basic and diluted weighted average number
of common shares
outstanding |
|
|
70,715 |
|
|
|
61,498 |
|
|
|
56,403 |
|
Basic and diluted net loss per common share |
|
$ |
(0.87 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.24 |
) |
The following common shares were excluded from the calculation of diluted net loss per common
share because their effect was antidilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options |
|
|
7,032 |
|
|
|
5,560 |
|
|
|
5,678 |
|
Contingently issuable shares to related party |
|
|
1,735 |
|
|
|
|
|
|
|
1,871 |
|
70
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
5. Marketable Securities and Fair Value Measurements
We invest our cash in accounts held at large U.S. based financial institutions and consider
our investment portfolio as marketable securities available-for-sale. The fair values of
available-for-sale investments by type of security were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Gross Unrealized |
|
|
|
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Market Value |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Type of security: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
17,719 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
17,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,719 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
17,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Gross Unrealized |
|
|
|
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Market Value |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Type of security: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
40,806 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
40,806 |
|
Auction rate security |
|
|
1,584 |
|
|
|
|
|
|
|
|
|
|
|
1,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
42,390 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
42,390 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended
December 31, 2010 and 2009, $17.7 million and
$40.8 million, respectively, of our
investments were classified as cash equivalents and included as part of cash and cash equivalents
in the consolidated balance sheets. For the year ended December 31, 2009, we held an auction rate
security valued at $1.6 million. This investment was classified as marketable securities,
non-current on our consolidated balance sheet and had a maturity date of greater than ten years.
The following table is a rollforward of our assets whose fair value is determined on a
recurring basis using significant unobservable inputs (Level 3):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
Beginning balance |
|
$ |
1,584 |
|
|
$ |
1,710 |
|
Purchases, sales and settlements |
|
|
(1,476 |
) |
|
|
|
|
Total realized/unrealized losses recognized in earnings |
|
|
(108 |
) |
|
|
(126 |
) |
|
|
|
|
|
|
|
Ending balance |
|
$ |
|
|
|
$ |
1,584 |
|
|
|
|
|
|
|
|
For the years ended December 31, 2010 and 2009, our cash equivalents were classified as Level
2 assets. At December 31, 2009, we held one investment in an auction rate security, which did not
actively trade. This security was classified as Level 3 and represented 3.7% of total assets that
were measured on a recurring basis as of December 31, 2009. We determined the fair value of this
security based on a cash flow model which incorporated a three-year discount period, a 1.97% per
annum coupon rate, a 0.519% per coupon payment discount rate (which integrated a liquidity discount
rate, 3-year swap forward rate and credit spread), as well as coupon history as of December 31,
2009. We also considered in determining the fair value that our holding in the auction rate
security was backed by the United States government and that the security was rated A3 at December
31, 2009. Due to our intent to sell the investment and the calculated fair value being less than
the cost basis, we deemed the decline of the securitys estimated valuation to be
other-than-temporary and recorded an impairment charge of $0.1 million in the year ended December
31, 2009. The fair value of the security was estimated to be $1.6 million at December 31, 2009. In
the six months ended June 30, 2010, we sold this security for $1.5 million and recognized a
realized loss of $0.1 million.
71
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
6. Property and Equipment, Net
Property and equipment consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
Useful Life |
|
December 31, |
|
|
|
(Years) |
|
2010 |
|
|
2009 |
|
|
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
Scientific equipment |
|
7 |
|
$ |
6,740 |
|
|
$ |
8,243 |
|
Computer equipment and software |
|
2 |
|
|
4,021 |
|
|
|
3,972 |
|
Enterprise software |
|
5 |
|
|
2,599 |
|
|
|
2,599 |
|
Office furniture and equipment |
|
5 7 |
|
|
1,386 |
|
|
|
1,546 |
|
Leasehold improvements |
|
* |
|
|
10,287 |
|
|
|
11,488 |
|
Construction-in-progress |
|
|
|
|
94 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,127 |
|
|
|
27,884 |
|
Less accumulated depreciation |
|
|
|
|
(17,948 |
) |
|
|
(17,793 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,179 |
|
|
$ |
10,091 |
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Shorter of asset life or lease term |
Depreciation and amortization expense related to property and equipment for the years ended
December 31, 2010, 2009 and 2008 was $3.4 million, $3.9 million and $4.2 million, respectively.
7. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
Research and development contract costs |
|
$ |
1,948 |
|
|
$ |
1,342 |
|
Payroll and benefits |
|
|
3,232 |
|
|
|
3,930 |
|
Professional fees |
|
|
797 |
|
|
|
647 |
|
Short-term portion of accrued settlement payment |
|
|
1,086 |
|
|
|
710 |
|
Restructuring costs |
|
|
147 |
|
|
|
416 |
|
Severance payments |
|
|
2,297 |
|
|
|
|
|
Other |
|
|
1,965 |
|
|
|
1,734 |
|
|
|
|
|
|
|
|
|
|
$ |
11,472 |
|
|
$ |
8,779 |
|
|
|
|
|
|
|
|
On October 28, 2010, Jean-Pierre Sommadossi, Ph.D., resigned from his positions as chairman of
the board of directors, president and chief executive officer. In connection with Dr. Sommadossis
resignation, he will receive severance payments of approximately $2.3 million that was included in
severance payments above.
8. Restructuring Charges
During the first quarter of 2010, we initiated a plan to restructure our operations at our
research facility in Montpellier, France to reduce its workforce by approximately 17 positions in
connection with our ongoing cost saving initiatives. In the first quarter of 2010, we recorded
charges of $2.2 million for employee severance costs related to the restructuring of our
Montpellier facility together with charges related to an earlier reduction of our United States
workforce by 13 positions in January 2010. Of this amount, $2.1 million of the severance costs were
paid and the remaining balance of $0.1 million continued to be accrued as of December 31, 2010.
In June 2009, we closed our lab facility in Cagliari, Italy and eliminated 18 employee
positions as a result of continuing cost saving initiatives. We recognized a charge of $1.5 million
for the quarter ended June 30, 2009. This amount consisted of $1.2 million of severance costs and
$0.3 million of contract termination costs associated with closing the lab facility. At December
31, 2009, the $0.4 million accrued expense related to restructuring costs included $0.2 million
related to the closing of our facility in Cagliari, Italy in 2009 and $0.2 million related to
exiting space at our Montpellier, France research facility. There was no amount accrued as of
December 31, 2010 related to this restructuring.
72
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
9. Equity Incentive Plans and Share-Based Compensation
In May 1998, we adopted the 1998 plan, which provides for the grant of incentive stock
options, nonqualified stock options, stock awards and stock appreciation rights. We initially
reserved approximately 1.5 million shares of common stock for issuance pursuant to the 1998 plan.
We subsequently amended the 1998 plan and reserved an additional 3.6 million shares of common stock
for issuance under the 1998 plan. No stock options, stock awards or stock appreciation rights may
be granted under the 1998 plan after June 29, 2008.
In July 2004, we adopted the 2004 stock incentive plan, or the 2004 plan. The 2004 plan
provided for the grant of incentive stock options, non-qualified stock options, stock appreciation
rights, performance share awards and restricted and unrestricted stock awards for the purchase of
an aggregate of 0.8 million shares of common stock.
In June 2005, we adopted the 2005 stock incentive plan, or the 2005 plan. The 2005 plan allows
for the granting of incentive stock options, non-qualified stock options, stock appreciation
rights, performance share awards and restricted stock awards, or awards. The 2005 plan, as approved
by our stockholders, provided for the authorization of awards covering an aggregate of 2.2 million
shares of common stock plus 0.8 million shares previously authorized for issuance under the 2004
plan. In connection with our public offering in October 2005, our board of directors reduced the
number of shares of common stock reserved for issuance under the 2005 plan to 1.4 million shares.
In March 2006, our board of directors authorized the restoration of the reserve of 1.6 million
shares for issuance under the 2005 plan. In May 2007, our stockholders approved an amendment to the
2005 plan increasing the number of shares of common stock from 3.0 million to 6.0 million shares.
In June 2010, our stockholders approved an amendment to the 2005 plan increasing the number of
shares of common stock from 6.0 million to 9.0 million shares.
The equity incentive plans are administered by the compensation committee of the board of
directors. The compensation committee determines the type and term of each award, the award
exercise or purchase price, if applicable, the number of shares underlying each award granted and
the rate at which each award becomes vested or exercisable. Incentive stock options may be granted
only to our employees at an exercise price per share of not less than the fair market value per
share of common stock as determined by the board of directors on the date of grant (not less than
110% of the fair market value in the case of holders of more than 10% of our voting common stock)
and with a term not to exceed ten years from date of grant (five years for incentive stock options
granted to holders of more than 10% of our voting common stock). Nonqualified stock options may be
granted to any officer, employee, director, consultant or advisor at a per share exercise price in
such amount as the compensation committee may determine. The compensation committee may also grant
restricted stock and other share-based awards on such terms and conditions as it may determine.
The following table shows share-based compensation expense as included in our consolidated
statements of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,214 |
|
|
$ |
1,546 |
|
|
$ |
2,005 |
|
General and administrative |
|
|
5,203 |
|
|
|
3,068 |
|
|
|
3,397 |
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation
expense |
|
$ |
6,417 |
|
|
$ |
4,614 |
|
|
$ |
5,402 |
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense is based on awards ultimately expected to vest. During the
years ended December 31, 2010, 2009 and 2008, because substantially all of our stock option grants
vest monthly, share-based employee compensation expense includes the actual impact of forfeitures.
The table below illustrates the fair value per share and Black-Scholes option pricing model
with the following assumptions used for grants issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average fair value of options |
|
$ |
2.03 |
|
|
$ |
3.12 |
|
|
$ |
2.99 |
|
Risk-free interest rate |
|
|
1.97 |
% |
|
|
1.94 |
% |
|
|
2.83 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected option term (in years) |
|
|
5.1 |
|
|
|
5.1 |
|
|
|
5.1 |
|
Expected volatility |
|
|
70.9 |
% |
|
|
70.2 |
% |
|
|
63.2 |
% |
No dividend yield was assumed as we do not pay dividends on our common stock. The risk-free
interest rate is based on the yield of United States Treasury securities consistent with the
expected term of the option. The expected option term and expected volatility were determined by examining the expected option term and expected volatilities of similarly sized
biotechnology companies as well as expected term and expected volatility of our stock.
73
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
The following table summarizes option activity under the equity incentive plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise Price |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
Shares |
|
|
per Share |
|
|
Contractual Term |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In Thousands) |
|
Options outstanding at December 31, 2009 |
|
|
5,559,727 |
|
|
$ |
7.72 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,280,721 |
|
|
$ |
3.67 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(601,366 |
) |
|
$ |
7.23 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(207,346 |
) |
|
$ |
2.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at December 31, 2010 |
|
|
7,031,736 |
|
|
$ |
6.61 |
|
|
|
5.13 |
|
|
$ |
4,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2010 |
|
|
5,465,719 |
|
|
$ |
7.35 |
|
|
|
4.11 |
|
|
$ |
3,184 |
|
Options vested and expected to vest at
December 31, 2010 |
|
|
6,832,069 |
|
|
$ |
6.69 |
|
|
|
5.01 |
|
|
$ |
4,711 |
|
The aggregate intrinsic value in the table above represents the total pre-tax amount, net of
exercise price, which would have been received by option holders if all option holders had
exercised all options with an exercise price lower than the market price on December 31, 2010,
based on the closing price of our common stock of $5.04 on that date.
The total intrinsic value of stock options exercised, which represents the amount by which the
fair market value exceeded the exercise price, during 2010, 2009 and 2008 was $0.5 million, $0.2
million and $1.3 million, respectively.
On October 28, 2010, Jean-Pierre Sommadossi, Ph.D., resigned from his positions as chairman of
the board of directors, president and chief executive officer. In connection with Dr. Sommadossis
resignation, he was granted approximately 0.3 million options and acceleration of all unvested
options. The related share-based compensation expense recognized in 2010 was $2.7 million.
We had an aggregate of $3.7 million of share-based compensation expense as of December 31,
2010 remaining to be amortized over a weighted average expected term of 2.43 years.
10. Income Taxes
Our effective income tax rate differs from the statutory federal income tax rate was as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal statutory rate benefit |
|
|
(34 |
)% |
|
|
(34 |
)% |
|
|
(34 |
)% |
State tax benefit, net of federal
expense (benefit) |
|
|
(2 |
) |
|
|
2 |
|
|
|
1 |
|
Permanent items |
|
|
1 |
|
|
|
(1 |
) |
|
|
1 |
|
Other |
|
|
1 |
|
|
|
(3 |
) |
|
|
|
|
Valuation allowance |
|
|
34 |
|
|
|
36 |
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
Effective income tax rate |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
74
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
The components of our net deferred taxes were as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
$ |
1,672 |
|
|
$ |
1,340 |
|
Development contracts |
|
|
1,233 |
|
|
|
1,436 |
|
Nonqualified stock options |
|
|
7,202 |
|
|
|
5,450 |
|
Deferred licensing income |
|
|
16,916 |
|
|
|
13,020 |
|
Accrued expenses and other |
|
|
2,669 |
|
|
|
3,137 |
|
Capitalized research costs |
|
|
58,661 |
|
|
|
51,838 |
|
Research and development credits |
|
|
9,632 |
|
|
|
9,143 |
|
Foreign tax credit carryforward |
|
|
877 |
|
|
|
877 |
|
Net operating carryforwards |
|
|
90,656 |
|
|
|
82,063 |
|
Valuation allowance |
|
|
(189,518 |
) |
|
|
(168,304 |
) |
|
|
|
|
|
|
|
Deferred tax asset |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
As of December 31, 2010, we had United States federal and state net operating loss
carryforwards of $244.0 million and $145.2 million, respectively, which may be available to offset
future federal and state income tax liabilities. The federal net operating loss carryforwards begin
to expire in 2022 and the state net operating loss carryforwards begin to expire in 2011.
Approximately $9.0 million of the net operating loss carryforwards available for federal and state
income tax purposes relate to exercises of employee stock options, the tax benefit of which, if
realized, will be credited to additional paid-in capital. We have federal and state research and
development credits of $7.6 million and $3.1 million, respectively. The federal research and
development credits begin to expire in 2022 and the state credits begin to expire in 2021. We also
have foreign credit carryforwards of $0.9 million, which begin to expire in 2016.
Ownership changes, as defined in the Internal Revenue Code, may limit the amount of net
operating loss carryforwards that can be utilized annually to offset future taxable income.
Subsequent ownership changes could further affect the limitation in future years.
Our management has evaluated the positive and negative evidence bearing upon the realization
of our deferred tax assets, which are comprised principally of net operating loss carryforwards,
deferred licensing income, capitalized research costs and research and development credit
carryforwards. Management has determined that it is more likely than not that we will not realize
the benefits of federal, state and foreign deferred tax assets and, as a result, a valuation
allowance of $189.5 million has been established at December 31, 2010.
There were no significant changes to the balance of unrecognized tax benefits in 2010 or 2009
as compared to 2007 when we adopted FASB guidance related to unrecognized tax benefits. The total
amount of unrecognized tax benefits was $1.5 million at December 31, 2010. Of this amount, $0.4
million will impact the effective tax rate if ultimately realized and $1.1 million would be offset
by an increase in the valuation allowance on deferred tax assets.
Our policy is to classify interest and penalties associated with uncertain tax positions as
other income, net in our consolidated statements of operations. As of December 31, 2010, we have
accrued $0.5 million related to interest and penalties for uncertain tax positions. Of this amount,
less than $0.1 million, $0.2 million and $0.1 million was included in other income, net for the
years ended December 31, 2010, 2009 and 2008, respectively.
The open tax years by major jurisdiction are: a) the years ended December 31, 2007 through
2009 for the United States; and b) the years ended December 31, 2008 and 2009 for France.
11. Employee Benefit Plans
We maintain a retirement savings plan under Section 401(k) of the Internal Revenue Code, or
the 401(k) plan. The 401(k) plan allows participants to defer a portion of their annual
compensation on a pre-tax basis and covers substantially all of our United States employees who
meet minimum age and service requirements.
We match 25% of employee contributions up to 6% of participants annual compensation. We made
contributions to the 401(k) plan of $0.1 million in each of the years ended December 31, 2010, 2009
and 2008.
We are required by statute to maintain a defined benefit plan for our employees in France. We
have recorded $0.3 million and $0.4 million in other long-term liabilities related to this benefit
plan as of December 31, 2010 and 2009, respectively.
75
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
12. Related Party Transactions
In connection with the development and commercialization agreement, we have generated revenues
from Novartis related to royalty revenue associated with the sale of Tyzeka®/Sebivo®, license
payments and reimbursements of certain research and development expenses in the amount of $6.2
million, $11.7 million and $9.8 million for the years ended December 31, 2010, 2009 and 2008,
respectively. All amounts included in receivables from related party at December 31, 2010 and 2009
are due from Novartis. We also included $31.6 million and $36.9 million as deferred revenue as of
December 31, 2010 and 2009, respectively, relating to non-refundable payments received from
Novartis.
13. Segment Reporting
We operate in a single segment, we have no organizational structure dictated by product lines,
geography or customer type and all significant revenues are generated from operations in the United
States. The following table presents total long-lived assets by geographic area:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
5,301 |
|
|
$ |
7,346 |
|
France |
|
|
1,878 |
|
|
|
2,745 |
|
|
|
|
|
|
|
|
|
|
$ |
7,179 |
|
|
$ |
10,091 |
|
|
|
|
|
|
|
|
14. Collaborative Agreements and License Agreements
Our collaborative agreement with Novartis is fully described in Note 3 to the consolidated
financial statements.
GlaxoSmithKline Collaboration
In February 2009, we entered into the GSK license agreement. In October 2009, GlaxoSmithKline
assigned the GSK license agreement to ViiV Healthcare Company, an affiliate of GlaxoSmithKline. The
GSK license agreement granted GSK an exclusive worldwide license to develop, manufacture and
commercialize our NNRTI compounds, including IDX899, for the treatment of human diseases, including
HIV/AIDS. We also entered into a stock purchase agreement with GSK in February 2009, which we refer
to as the GSK stock purchase agreement. Under the GSK stock purchase agreement, GSK purchased
approximately 2.5 million shares of our common stock at an aggregate purchase price of $17.0
million, or a per share price of $6.87. These agreements became effective in March 2009.
In March 2009, we received $34.0 million from GSK, which consisted of a $17.0 million license
fee payment under the GSK license agreement and $17.0 million under the GSK stock purchase
agreement. In May 2010, we received a $6.5 million related to the achievement of a preclinical
operational milestone and in November 2010, we received a $20.0 million milestone payment for the
initiation of a phase IIb clinical study related to the development of 761. Pursuant to the GSK
license agreement, we could also potentially receive up to $390.0 million in additional milestone
payments as well as double-digit tiered royalties on worldwide product sales. The parties have
agreed that if GSK, its affiliates or its sublicensees desire to develop 761 for an indication
other than HIV, or if GSK intends to develop any other licensed compound for any indication, the
parties will mutually agree on a separate schedule of milestone and royalty payments prior to the
start of development.
The GSK license agreement has performance obligations, including joint committee participation
and GSKs right to license other NNRTI compounds that we may develop in the future, that we have
assessed under the FASB guidance related to multiple element arrangements. We concluded that this
arrangement should be accounted for as a single unit of accounting and recognized using the
contingency adjusted performance method. The $43.5 million payments from GSK were recorded as
deferred revenue and are being recognized as revenue over the life of the agreement, which is
estimated to be 17 years. A cumulative catch-up was recognized for the period from the execution of
the license agreement in March 2009 through the period in which the milestone payments are
received. We recognized $4.0 million and $0.9 million of collaboration revenue for the years ended
December 31, 2010 and 2009, respectively, and recorded $38.7
million and $16.1 million of deferred revenue as of December 31, 2010 and 2009, respectively,
relating to payments received from GSK.
In February 2011, GSK informed us that the FDA placed 761 on clinical hold. GSK has full
responsibility for the development of 761, including any regulatory interactions.
Under the terms of the GSK stock purchase agreement, in June 2009, we filed a registration
statement with the SEC covering the shares GSK purchased from us. We have also agreed to cooperate in one underwritten offering of the
purchased shares, including the entry into an underwriting agreement with customary terms, provided
that such underwritten offering occurs after the first anniversary of the closing date. The GSK
stock purchase agreement may be terminated by mutual agreement of the parties.
76
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
GSK has also become a party to the cooperative research program and exclusive license
agreement we have with the Universita degli Studi di Cagliari, or the University of Cagliari, which
is more fully described below under the University of Cagliari heading.
In connection with the GSK license agreement and stock purchase agreement, Novartis waived and
amended certain rights under the development and commercialization agreement and amended a letter
agreement related to the selection and appointment of our chief financial officer. Novartis also
executed a waiver and consent under the amended and restated stockholders agreement. These waivers
and amendments are more fully described in Part I. Item 1 of this Annual Report on Form 10-K under
the heading GlaxoSmithKline Collaboration.
University of Cagliari
In January 1999, we entered into a cooperative antiviral research activity agreement, as
amended with the Dipartimento di Biologia Sperimentale Bernardo Loddo dellUniversita di Cagliari
pursuant to which we acquired an exclusive license to certain antiviral technology. We are required
to make royalty payments to the University of Cagliari upon commercialization of any products
resulting from the licensed technology. We were also required to make payments to the University of
Cagliari for use of the facilities and for supplies consumed in connection with the research
activities. This agreement terminated in December 2010. We incurred expenses of approximately $0.1
million and $0.2 million for the years ended December 31, 2009 and 2008, respectively, in
connection with this agreement. There were no significant expenses incurred during 2010.
In December 2000, we and the University of Cagliari also entered into a license agreement
pursuant to which we were granted an exclusive license under certain patent rights resulting from
specified research activities. In May 2003, we, the University of Cagliari and Novartis entered
into an amendment of these agreements, pursuant to which Novartis was granted the right, under
certain circumstances, to prosecute and enforce patents resulting from the research activities, and
to assume our rights under the agreement if the agreement terminates due to an uncured breach of
the agreement by us. In October 2005, we and the University of Cagliari amended such agreements in
a manner that will require certain payments to the University of Cagliari if we receive license
fees or milestone payments in connection with a sublicense by us of technology covered by the
agreements between the University of Cagliari and us.
In March 2009, GSK became a party to the cooperative research program and exclusive license
agreement we have with the University of Cagliari, the co-owner of certain patents and patent
applications licensed by us to GSK under the GSK license agreement. Under these arrangements, we
are liable for certain payments to the University of Cagliari if we receive license fees or
milestone payments with respect to such technology. We have made certain payments to the University
of Cagliari based on the payments we received from GSK. Although certain patent rights licensed to
GSK are owned solely by us and do not fall under the arrangements with the University of Cagliari,
we have entered into an arrangement whereby if it is ever deemed that any patent owned solely by us
and licensed to GSK was co-developed by anyone on the faculty of the University of Cagliari, such
co-development will fall within the existing arrangements with the University of Cagliari and no
additional payments would be due by us.
Sumitomo Pharmaceuticals Co., Ltd.
We entered into collaborative agreements with Sumitomo in 2001, in connection with the
development and commercialization in Japan, China, Taiwan, and South Korea of telbivudine, a drug
for the treatment of HBV. In connection with this arrangement, we and Sumitomo agreed to share
certain direct third-party expenses of development of telbivudine.
In March 2003, we entered into a final settlement agreement with Sumitomo under which the
rights to develop and commercialize telbivudine in Japan, China, South Korea and Taiwan previously
granted to Sumitomo were returned to us. This agreement with Sumitomo became effective upon
consummation of our collaboration with Novartis in May 2003. We repurchased these product rights
for $5.0 million and as a result of this payment, we reversed approximately $4.6 million of revenue
previously recognized in original arrangements with Sumitomo with the remaining amount recorded as
a reduction of deferred revenue.
We also have recorded $4.3 million included as deferred revenue, net of current portion in our
consolidated balance sheets at each of December 31, 2010 and 2009 representing amounts received
from Sumitomo that have not been included in revenue to date. We are required to pay an additional
$5.0 million to Sumitomo if and when the first commercial sale of telbivudine occurs in Japan. This
payment will be recorded first as a reduction of the remaining $4.3 million of deferred revenue,
with the excess recorded as an expense. As part of the development and commercialization agreement,
we will be reimbursed by Novartis for any such payment made to Sumitomo. If regulatory approval is
not received for telbivudine in Japan, we would have no further obligations under the settlement
agreement with Sumitomo and therefore, the $4.3 million of remaining deferred revenue would be recognized as revenue at that
time.
77
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
15. Commitments and Contingencies
Lease Arrangements
We lease our facilities and certain equipment under operating leases. Our lease arrangements
have terms through the year 2017. Total rent expense under operating leases was approximately $3.3
million, $3.0 million and $3.2 million for the years ended December 31, 2010, 2009 and 2008,
respectively. Future minimum payments under lease arrangements at December 31, 2010 were as
follows:
|
|
|
|
|
|
|
Operating |
|
Years Ending December 31, |
|
Leases |
|
|
|
(In Thousands) |
|
|
|
|
|
|
2011 |
|
$ |
3,133 |
|
2012 |
|
|
2,921 |
|
2013 |
|
|
2,797 |
|
2014 |
|
|
857 |
|
2015 |
|
|
845 |
|
2016 and thereafter |
|
|
1,053 |
|
|
|
|
|
Total |
|
$ |
11,606 |
|
|
|
|
|
In October 2003, we entered into an operating lease commitment for office and laboratory space
in Cambridge, Massachusetts. The term of the lease is for ten years, expiring in December 2013. The
lease agreement provided for a landlord allowance of $1.6 million to be paid to us to finance a
portion of capital improvements to the facility. This landlord allowance was recorded as deferred
rent which is being amortized as a reduction of rent over the ten year lease term. In connection
with this operating lease commitment, a commercial bank issued a letter of credit in October 2003
for $0.8 million collateralized by cash held with that bank. The letter of credit expires in
December 2013.
In April 2005, we entered into a lease agreement for office and laboratory space in
Montpellier, France. The term of the lease is for 12 years, expiring in April 2017 but is
cancellable by either party after six years. The lease agreement also includes an option entitling
us to purchase the building at any time after April 16, 2011. The purchase option extends until the
expiration of the lease term. In January 2011, we amended this lease agreement to terminate the
lease of certain floors in the building.
In June 2005, we entered into a lease agreement for additional office space in Cambridge,
Massachusetts. We entered into amendments to this lease agreement to lease additional office space
in the same building. The term of the lease for all office space being rented under this lease
agreement and its amendments expired in March 2010. In 2010, we extended the term of the lease
through December 2013 for certain floors of the building under the same conditions of the original
agreement. We also have been provided allowances totaling $1.2 million to finance a portion of
capital improvements to the facility. These allowances have been recorded as deferred rent which is
being amortized as a reduction of rent over the lease term. In connection with this operating lease
commitment, a commercial bank issued a letter of credit in May 2005 for $0.4 million collateralized
by cash we have on deposit with that bank. The letter of credit expires in May 2011. In 2010 and
2009, we subleased portions of our Cambridge office space to two third-parties. As of December 31,
2010 and 2009, we received less than $0.1 million and $0.3 million in sublease payments,
respectively. The sublease income reduced the rental expense through March 2010 when the sublease
agreements expired.
Contingencies
Hepatitis C Drug Candidates
In connection with the resolution of matters relating to certain of our HCV drug candidates,
in May 2004, we entered into a settlement agreement with UAB which provides for a milestone payment
of $1.0 million to UAB upon receipt of regulatory approval in the United
States to market and sell certain HCV products invented or discovered by our former chief
executive officer during the period from November 1, 1999 to November 1, 2000. This settlement
agreement also provides that we will pay UAB an amount equal to 0.5% of worldwide net sales of such
HCV products with a minimum sales-based payment equal to $12.0 million. Currently, there are no
such HCV products approved and therefore there was no related liability recorded as of December 31,
2010.
78
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
We have potential payment obligations under the license agreement with the University of
Cagliari, pursuant to which we have the exclusive worldwide right to make, use and sell certain HCV
and HIV technologies. We made certain payments to the University of Cagliari
under these arrangements based on the payments we received from GSK under the GSK license
transaction. We are also liable for certain payments to the University of Cagliari if we receive
license fees or milestone payments with respect to such technology from Novartis, GSK or another
collaborator.
Hepatitis B Product
Pursuant to the license agreement between us and UAB, we were granted an exclusive license to
the rights that UABRF, an affiliate of UAB, Emory University and CNRS have to a 1995 U.S. patent
application and progeny thereof and counterpart patent applications in Europe, Canada, Japan and
Australia that cover the use of certain synthetic nucleosides for the treatment of HBV. In July
2008, we entered into a settlement agreement with UAB, UABRF and Emory University relating to our
telbivudine technology. Pursuant to this settlement agreement, all contractual disputes relating to
patents covering the use of certain synthetic nucleosides for the treatment of HBV and all
litigation matters relating to patents and patent applications related to the use of
ß-L-2-deoxy-nucleosides for the treatment of HBV assigned to one or more of Idenix, CNRS and the
University of Montpellier and which cover the use of telbivudine (Tyzeka®/Sebivo®) for the
treatment of HBV have been resolved. UAB also agreed to abandon certain continuation patent
applications it filed in July 2005. Under the terms of the settlement agreement, we paid UABRF (on
behalf of UAB and Emory University) a $4.0 million upfront payment and will make additional
payments to UABRF equal to 20% of all royalty payments received by us from Novartis from worldwide
sales of telbivudine, subject to minimum payment obligations aggregating $11.0 million. Our payment
obligations under the settlement agreement expire in August 2019. The settlement agreement was
effective on June 1, 2008 and included mutual releases of all claims and covenants not to sue among
the parties. It also included a release from a third-party scientist who had claimed to have
inventorship rights in certain Idenix/CNRS/University of Montpellier patents.
In May 2003, we and Novartis entered into an amended and restated agreement with CNRS and the
University of Montpellier pursuant to which we worked in collaboration with scientists from CNRS
and the University of Montpellier to discover and develop technologies relating to antiviral
substances, including telbivudine. This cooperative agreement expired in December 2006, but we
retain rights to exploit the patents derived from the collaboration. Under the cooperative
agreement, we are obligated to make royalty payments for products derived from such patents.
Legal Contingency
In December 2001, we retained the services of Clariant (subsequently acquired by Archimica
Group), a provider of manufacturing services in the specialty chemicals industry, in the form of a
multiproject development and supply agreement. Under the terms of the agreement with Clariant, we
would, on an as needed basis, utilize the Clariant process development and manufacture services
in the development of certain of our drug candidates, including telbivudine. After reviewing
respective bids from each of Novartis and Clariant, the joint manufacturing committee of Idenix and
Novartis decided to proceed with Novartis as the primary manufacturer of telbivudine. In late 2007,
we transferred full responsibility to Novartis for the development, commercialization and
manufacturing of telbivudine. As a result, in January 2008, we exercised our right under the
agreement with Clariant to terminate the relationship effective July 2008. In February 2008,
Clariant asserted that they should have been able to participate in the manufacturing process for
telbivudine as a non-primary supplier and therefore are due an unspecified amount. We do not agree
with Clariants assertion and therefore have not recorded a liability associated with this
potential contingent matter. Clariant has not initiated legal proceedings. If legal proceedings are
initiated, we intend to vigorously defend against such lawsuit.
Other Legal Contingency
We have been involved in a dispute with the City of Cambridge, Massachusetts and its License
Commission pertaining to the level of noise emitted from certain rooftop equipment at our research
facility located at 60 Hampshire Street in Cambridge. The License Commission has claimed that we
are in violation of the local noise ordinance pertaining to sound emissions, based on a complaint
from neighbors living adjacent to the property. We have contested this alleged violation before the
License Commission, as well as the Middlesex County, Massachusetts, Superior Court. In July 2010,
the License Commission granted us a special variance from the requirements of the local noise
ordinance for a period of one-year, effective as of July 1, 2010. We may, however, be required to
cease certain activities at the building if: a) the noise emitted from certain rooftop equipment at
our research facility exceeds the levels permitted by the special variance; b) the parties are
unable to resolve this matter through negotiations and remedial action; or c) our legal challenge
to the position of the City of Cambridge
and the License Commission is unsuccessful. In any such event, we could be required to
relocate to another facility which could interrupt some of our business activities and could be
time consuming and costly.
79
IDENIX PHARMACEUTICALS, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS CONTINUED
Indemnification
We have agreed to indemnify Novartis and its affiliates against losses suffered as a result of
any breach of representations and warranties in the development and commercialization agreement and
the stock purchase agreement. Under these agreements with Novartis, we made
numerous representations and warranties to Novartis regarding our HBV and HCV drug candidates,
including representations regarding our ownership of the inventions and discoveries. If one or more
of these representations or warranties were subsequently determined not to be true at the time they
were made to Novartis, we would be in breach of one or both of these agreements. In the event of
such a breach, Novartis has the right to seek indemnification from us and, under certain
circumstances, us and our stockholders who sold shares to Novartis, which include many of our
directors and officers, for damages suffered by Novartis as a result of such breach. While it is
possible that we may be required to make payments pursuant to the indemnification obligations we
have under these agreements, we cannot reasonably estimate the amount of such payments or the
likelihood that such payments would be required.
Under the GSK license agreement and the GSK stock purchase agreement, we have agreed to
indemnify GSK and its affiliates against losses suffered as a result of our breach of
representations and warranties in these agreements. We made numerous representations and warranties
to GSK regarding our NNRTI program, including IDX899, as well as representations regarding our
ownership of inventions and discoveries. If one or more of these representations or warranties were
subsequently determined not to be true at the time we made them to GSK, we would be in breach of
these agreements. In the event of such a breach, GSK has the right to seek indemnification from us
for damages suffered as a result of such breach. While it is possible that we may be required to
make payments pursuant to the indemnification obligations we have under these agreements, we cannot
reasonably estimate the amount of such payments or the likelihood that such payments would be
required.
16. Quarterly Financial Data
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First |
|
|
Second |
|
|
Third |
|
|
Fourth |
|
|
Total |
|
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Quarter |
|
|
Year |
|
|
|
(In Thousands, Except per Share Data) |
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
2,683 |
|
|
$ |
1,316 |
|
|
$ |
3,788 |
|
|
$ |
2,435 |
|
|
$ |
10,222 |
|
Total operating expenses |
|
|
19,335 |
|
|
|
17,915 |
|
|
|
16,643 |
|
|
|
19,055 |
|
|
|
72,948 |
|
Net loss |
|
|
(16,212 |
) |
|
|
(16,256 |
) |
|
|
(12,930 |
) |
|
|
(16,157 |
) |
|
|
(61,555 |
) |
Basic and diluted net loss per common share |
|
|
(0.24 |
) |
|
|
(0.23 |
) |
|
|
(0.18 |
) |
|
|
(0.22 |
) |
|
|
(0.87 |
) |
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
4,011 |
|
|
$ |
2,449 |
|
|
$ |
3,107 |
|
|
$ |
3,049 |
|
|
$ |
12,616 |
|
Total operating expenses |
|
|
17,326 |
|
|
|
18,755 |
|
|
|
15,102 |
|
|
|
15,867 |
|
|
|
67,050 |
|
Net loss |
|
|
(12,926 |
) |
|
|
(16,314 |
) |
|
|
(11,667 |
) |
|
|
(12,312 |
) |
|
|
(53,219 |
) |
Basic and diluted net loss per common share |
|
|
(0.23 |
) |
|
|
(0.28 |
) |
|
|
(0.18 |
) |
|
|
(0.19 |
) |
|
|
(0.87 |
) |
80
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
IDENIX PHARMACEUTICALS, INC.
|
|
Date: March 7, 2011 |
/s/ Ronald C. Renaud, Jr.
|
|
|
Ronald C. Renaud, Jr. |
|
|
President and Chief Executive Officer |
|
Pursuant to the requirements of the Securities Act of 1934, this report has been signed below
by the following persons on behalf of the registrant and in the capacities and on the dates
indicated.
|
|
|
|
|
Name |
|
Title |
|
Date |
|
|
|
|
|
/s/ Ronald C. Renaud, Jr.
Ronald C. Renaud, Jr.
|
|
President and Chief Executive Officer and
Director (Principal Executive Officer)
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Daniella Beckman
Daniella Beckman
|
|
Interim Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Charles Cramb
Charles Cramb
|
|
Director
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Wayne Hockmeyer
Wayne Hockmeyer
|
|
Director
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Thomas Hodgson
Thomas Hodgson
|
|
Director
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Tamar Howson
Tamar Howson
|
|
Director
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Robert Pelzer
Robert Pelzer
|
|
Director
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Denise Pollard-Knight
Denise Pollard-Knight
|
|
Director
|
|
March 7, 2011 |
|
|
|
|
|
/s/ Anthony Rosenberg
Anthony Rosenberg
|
|
Director
|
|
March 7, 2011 |
81
EXHIBIT INDEX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
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|
Exhibit |
|
Filing |
|
SEC |
Number |
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Description |
|
Form |
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No. |
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Date |
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File Number |
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Articles of Incorporation and By-Laws |
|
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3.1
|
|
|
Restated Certificate of Incorporation of the Registrant
|
|
S-1
|
|
|
3.1 |
|
|
12/15/2003
|
|
333-111157 |
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3.2
|
|
|
Certificate of Amendment of Restated Certificate of Incorporation
|
|
10-Q for 6/30/2004
|
|
|
3.1 |
|
|
8/26/2004
|
|
000-49839 |
|
|
|
|
|
|
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|
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|
3.3
|
|
|
Certificate of Amendment of Restated Certificate of Incorporation
|
|
10-K for 12/31/2005
|
|
|
3.3 |
|
|
3/16/2006
|
|
000-49839 |
|
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|
|
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|
3.4
|
|
|
Certificate of Amendment of Restated Certificate of Incorporation
|
|
10-K for 12/31/2007
|
|
|
3.4 |
|
|
3/14/2008
|
|
000-49839 |
|
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3.5
|
|
|
Amended and Restated By-Laws
|
|
10-Q for 6/30/2004
|
|
|
3.2 |
|
|
8/26/2004
|
|
000-49839 |
|
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|
4.1
|
|
|
Specimen Certificate evidencing the Common Stock, $.001 par value
|
|
S-1 Amendment 2
|
|
|
4.1 |
|
|
1/27/2004
|
|
333-111157 |
|
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Material contracts real estate |
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10.1
|
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|
Lease Agreement, dated as of October 15, 1998, by and between
Idenix (Massachusetts) Inc. and CambridgePark One Limited
Partnership, as amended by the First Amendment to Lease dated as
of September 1, 2001
|
|
S-1
|
|
|
10.2 |
|
|
12/15/2003
|
|
333-111157 |
|
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|
10.2
|
|
|
Lease Agreement, dated as of August 22, 2001, by and between
Idenix (Massachusetts) Inc. and West Cambridge Sciences Park
|
|
S-1
|
|
|
10.3 |
|
|
12/15/2003
|
|
333-111157 |
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10.3
|
|
|
Amended and Restated Lease of Premises at 60 Hampshire Street,
Cambridge, Massachusetts, dated as of October 28, 2003, by and
between Idenix (Massachusetts) Inc. and BHX, LLC, as trustee of
205 Broadway Realty Trust
|
|
S-1
|
|
|
10.4 |
|
|
12/15/2003
|
|
333-111157 |
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10.4
|
|
|
Administrative Lease Hotel DEnterprises Cap Gamma dated April
18, 2005 by and among Idenix SARL, Societe DEquipment de la
Region Montpellieraine and the Communate DAgglomeration de
Montpellier (English Translation)
|
|
8-K
|
|
|
10.1 |
|
|
4/20/2005
|
|
000-49839 |
82
|
|
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|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
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|
10.5
|
+ |
|
Offer of Sale Hotel
|
|
8-K
|
|
|
10.2 |
|
|
4/20/2005
|
|
000-49839 |
|
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|
10.6
|
|
|
Joint Guarantee made as of December 15, 2005 between the
Registrant and Societe DEquipment de la Region
Montpellieraine
|
|
8-K
|
|
|
10.3 |
|
|
4/20/2005
|
|
000-49839 |
|
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|
10.7
|
|
|
Indenture of Lease, dated June 8, 2005, by and between
the Registrant and One Kendall Square Associates LLC
|
|
8-K
|
|
|
10.1 |
|
|
6/13/2005
|
|
000-49839 |
|
|
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|
|
|
|
|
|
|
|
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|
|
10.8
|
|
|
First Amendment of Lease dated July 24, 2006 by and
between the Registrant and RB Kendall Fee, LLC
|
|
10-Q for 6/30/2006
|
|
|
10.3 |
|
|
8/8/2006
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
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|
|
10.9
|
|
|
Second Amendment of Lease dated September 7, 2006 by and
between the Registrant and RB Kendall Fee, LLC
|
|
10-Q for 9/30/2006
|
|
|
10.1 |
|
|
11/8/2006
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.10
|
|
|
Third Amendment of Lease, dated July 23, 2009, between
RB Kendall Fee, LLC and the Registrant
|
|
10-Q for 9/30/2009
|
|
|
10.1 |
|
|
10/29/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.11
|
|
|
Fourth Amendment of Lease, dated June 29, 2010, between
RB Kendall Fee, LLC and the Registrant
|
|
10-Q for 6/30/2010
|
|
|
10.3 |
|
|
7/27/2010
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Material contracts Novartis Pharma AG and GlaxoSmithKline |
|
|
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|
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|
|
10.12
|
|
|
Letter Agreement, dated as of March 21, 2003, by and
between the Registrant and Novartis Pharma AG
|
|
S-1
|
|
|
10.28 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.13
|
|
|
Amendment No. 1 to Letter Agreement, dated on or about
January 28, 2009, by and between the Registrant and
Novartis Pharma AG
|
|
8-K
|
|
|
10.3 |
|
|
2/6/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.14
|
+ |
|
Restated and Amended Cooperative Agreement dated as of
May 8, 2003, by among Idenix SARL and Le Centre National
de la Recherche Scientifique, LUniversite Montpellier
II and Novartis Pharma AG
|
|
S-1
|
|
|
10.14 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.15
|
|
|
Letter Agreement, dated May 8, 2003, by and among the
Registrant, Idenix SARL, Novartis Pharma AG and the
University of Cagliari, amending the Cooperative
Agreement and License Agreement
|
|
S-1
|
|
|
10.19 |
|
|
12/15/2003
|
|
333-111157 |
83
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.16
|
+ |
|
Development,
License and
Commercialization
Agreement, dated as
of May 8, 2003, by
and among the
Registrant, Idenix
(Cayman) Limited
and Novartis Pharma
AG, as amended on
April 30, 2004
|
|
S-1 Amendment 3
|
|
|
10.24 |
|
|
7/6/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.17
|
+ |
|
Master
Manufacturing and
Supply Agreement,
dated as of May 8,
2003, by and
between Idenix
(Cayman) Limited
and Novartis Pharma
AG
|
|
S-1
|
|
|
10.25 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.18
|
+ |
|
Second Amendment,
dated as of
December 21, 2004,
to the Development,
License and
Commercialization
Agreement, by and
among the
Registrant, Idenix
(Cayman) Limited
and Novartis Pharma
AG, as amended on
April 30, 2004
|
|
10-K for 12/31/2004
|
|
|
10.16 |
|
|
3/17/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.19
|
+ |
|
Amendment No. 3 to
the Development,
License and
Commercialization
Agreement,
effective as of
February 27, 2006,
by and among the
Registrant, Idenix
(Cayman) Limited
and Novartis Pharma
AG
|
|
10-K for 12/31/2005
|
|
|
10.14 |
|
|
3/16/2006
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.20
|
+ |
|
Amendment No. 4 to
the Development,
License and
Commercialization
Agreement, dated as
of September 28,
2007, by and among
the Registrant,
Idenix (Cayman)
Limited and
Novartis Pharma AG
|
|
10-Q for 9/30/2007
|
|
|
10.1 |
|
|
11/8/2007
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.21
|
|
|
Amendment No. 5 to
the Development
License and
Commercialization
Agreement, dated on
or about January
28, 2009, between
the Registrant,
Idenix (Cayman)
Limited and
Novartis Pharma AG
|
|
8-K
|
|
|
10.2 |
|
|
2/6/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.22
|
+ |
|
Transition Services
Agreement, dated as
of September 28,
2007, by and among
the Registrant,
Idenix (Cayman)
Limited and
Novartis Pharma AG
|
|
10-Q for 9/30/2007
|
|
|
10.2 |
|
|
11/8/2007
|
|
000-49839 |
84
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.23
|
|
|
Amended and Restated
Stockholders
Agreement, dated July
27, 2004, by and
among the Registrant,
Novartis and the
stockholders
identified on the
signature pages
thereto
|
|
10-K for
12/31/2004
|
|
|
10.20 |
|
|
3/17/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.24
|
|
|
Par Value Stock
Purchase Agreement,
dated July 27, 2004,
by and between the
Registrant and
Novartis Pharma AG
|
|
10-K for
12/31/2004
|
|
|
10.21 |
|
|
3/17/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.25
|
+ |
|
Stock Purchase
Agreement, dated as
of March 21, 2003, by
and among the
Registrant, Novartis
and the stockholders
identified on the
signature pages
|
|
S-1 Amendment 3
|
|
|
10.27 |
|
|
7/6/2004
|
|
333-11115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.26
|
|
|
Concurrent Private
Placement Stock
Purchase Agreement,
dated July 27, 2004,
by and between the
Registrant and
Novartis Pharma AG
|
|
10-K for
12/31/2004
|
|
|
10.22 |
|
|
3/17/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.27
|
+ |
|
Commercial
Manufacturing
Agreement dated as of
June 22, 2006 by and
between the
Registrant and
Novartis Pharma AG
|
|
10-Q for
6/30/2006
|
|
|
10.1 |
|
|
8/8/2006
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.28
|
+ |
|
Packaging Agreement
dated as of June 22,
2006 by and between
the Registrant and
Novartis Pharma AG
|
|
10-Q for
6/30/2006
|
|
|
10.2 |
|
|
8/8/2006
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.29
|
|
|
Stock Purchase
Agreement, dated
February 4, 2009,
between the
Registrant and
SmithKline Beecham
Corporate
|
|
8-K
|
|
|
10.1 |
|
|
2/6/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.30
|
+ |
|
License Agreement,
dated February 4,
2009, between the
Registrant and
SmithKline Beecham
Corporate |
|
10-K for 12.31.2008
|
|
|
10.28 |
|
|
3/4/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.31
|
+ |
|
First Amendment of
License Agreement,
dated May 20, 2010,
between the
Registrant and ViiV
Healthcare Company,
successor to
SmithKline Beecham
Corporation |
|
10-Q for 6/30/2010
|
|
|
10.2 |
|
|
7/27/10
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
University of Cagliari |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.32
|
+ |
|
Cooperative Antiviral
Research Activity
Agreement (the
Cooperative
Agreement), dated
January 4, 1999, by
and between Idenix
SARL and the
University of
Cagliari
|
|
S-1
|
|
|
10.16 |
|
|
12/15/2003
|
|
333-111157 |
85
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.33
|
+ |
|
License Agreement,
dated as of December
14, 2000, between the
Registrant and the
University of Cagliari
|
|
S-1
|
|
|
10.17 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.34
|
+ |
|
Letter Agreement, dated
April 10, 2002, by and
between Idenix SARL and
the University of
Cagliari, amending the
Cooperative Agreement
and License Agreement
|
|
S-1
|
|
|
10.18 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.35
|
+ |
|
Agreement, dated June
30, 2004, by and among
the Registrant, Idenix
SARL and the University
of Cagliari
|
|
S-1 Amendment 3
|
|
|
10.18.1 |
|
|
7/6/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.36
|
|
|
Collaborative Activities
|
|
S-1
|
|
|
10.18.2 |
|
|
7/6/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.37
|
+ |
|
Agreement, dated
October 24, 2005, by
and among the
Registrant, Idenix SARL
and the Universita
degli Studi di Cagliari
|
|
10-Q for
9/30/2005
|
|
|
10.1 |
|
|
11/08/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.38
|
+ |
|
Amendment Agreement,
dated February 4, 2009,
by and among the
Registrant, Idenix
SARL, SmithKline
Beecham Corporate,
Universita degli Studi
di Cagliari and Paolo
LaColla
|
|
10-K for
12/31/2008
|
|
|
10.35 |
|
|
3/4/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Miscellaneous |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.39
|
|
|
License Agreement dated
as of June 20, 1998 by
and between the
Registrant and the UAB
Research Foundation, as
amended by that First
Amendment Agreement,
dated as of June 20,
1998, and by that
Second Amendment
Agreement, dated as of
July 16, 1999
|
|
S-1 Amendment 2
|
|
|
10.31 |
|
|
6/1/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.40
|
+ |
|
Master Services
Agreement, dated
February 25, 2003, by
and between the
Registrant and
Quintiles, Inc.
|
|
S-1
|
|
|
10.21 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.41
|
|
|
Master Services
Agreement, dated May
27, 1999, between
Idenix (Massachusetts),
Inc. and Quintiles
Scotland Ltd
|
|
S-1
|
|
|
10.20 |
|
|
12/15/2003
|
|
333-111157 |
86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.42
|
|
|
Multiproject
Development and
Supply Agreement,
dated as of
December 20, 2001,
by and among the
Registrant, Idenix
SARL and Clariant
Life Science
Molecules
(Missouri) Inc.
|
|
S-1
|
|
|
10.22 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.43
|
+ |
|
Agreement, dated as
of May 1, 2003,
between Idenix
(Cayman Limited and
Microbiologica
Quimica E
Farmaceutica Ltda.
|
|
S-1 Amendment 3
|
|
|
10.23 |
|
|
7/6/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.44
|
|
|
Final Settlement
Agreement, dated
March 26, 2003, by
and between the
Registrant and
Sumitomo
Pharmaceuticals
Co., Ltd.
|
|
S-1
|
|
|
10.13 |
|
|
12/15/2003
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.45
|
|
|
Settlement
Agreement, dated as
of May 28, 2004, by
and between the
Registrant,
Jean-Pierre
Sommadossi, the
University of
Alabama at
Birmingham and the
University of
Alabama Research
Foundation
|
|
S-1 Amendment 2
|
|
|
10.34 |
|
|
6/1/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.46
|
|
|
Settlement
Agreement,
effective June 1,
2008, by and among
the Registrant,
Jean-Pierre
Sommadossi, the
University of
Montpellier II, Le
Centre National de
la Recherche
Scientifique, the
Board of Trustees
of the University
of Alabama on
behalf of the
University of
Alabama at
Birmingham, the
University of
Alabama Research
Foundation and
Emory University
|
|
8-K
|
|
|
10.1 |
|
|
8/5/2008
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.47
|
|
|
Master Service
Agreement, dated
April 1, 2008, by
and between the
Registrant and
Parexel
International LLC
|
|
10-Q for
6/30/2008
|
|
|
10.1 |
|
|
8/7/2008
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.48
|
+ |
|
Agreement, dated
December 3, 2008,
by and between the
Registrant and
Paolo LaColla
|
|
10-K for
12/31/2008
|
|
|
10.46 |
|
|
3/4/2009
|
|
000-49839 |
87
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.49
|
+ |
|
Master Agreement for Clinical Trial Management
Services, dated September 16, 2009, between
Pharmaceutical Research Associates, Inc. and the
Registrant
|
|
10-Q for
9/30/2009
|
|
|
10.2+ |
|
|
10/29/2009
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.50
|
|
|
Master Agreement for Clinical Research Services, dated
January 30, 2009, by and
between Registrant and
ACLIRES International, Ltd.
|
|
10-K for 12/31/2009
|
|
|
10.49 |
|
|
3/9/2010
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Material contracts management contracts and
compensatory plans |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.51 |
#
|
|
Form of Incentive Stock Option Agreement for awards
granted pursuant to the 2005 Stock Incentive Plan, as
amended
|
|
8-K
|
|
|
10.2 |
|
|
6/13/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.52 |
#
|
|
Form of Non-Statutory Stock Option Agreement for
awards granted pursuant to the 2005 Stock Incentive
Plan, as amended
|
|
8-K
|
|
|
10.3 |
|
|
6/13/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.53 |
#
|
|
Form of Incentive Stock Option Agreement for awards
granted pursuant to the 2004 Stock Incentive Plan
|
|
10-K for
12/31/2004
|
|
|
10.28 |
|
|
3/17/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.54 |
#
|
|
Form of Non-Statutory Stock Option Agreement for
awards granted pursuant to the 2004 Stock Incentive
Plan
|
|
10-K for
12/31/2004
|
|
|
10.29 |
|
|
3/17/2005
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.55 |
#
|
|
2005 Stock Incentive Plan, as amended
|
|
10-Q for
6/30/2010
|
|
|
10.1 |
|
|
7/27/2010
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.56 |
#
|
|
2004 Stock Incentive Plan
|
|
S-1 Amendment 2
|
|
|
10.32 |
|
|
5/28/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.57 |
#
|
|
Amended and Restated 1998 Equity Incentive Plan
|
|
S-1 Amendment 2
|
|
|
10.1 |
|
|
6/1/2004
|
|
333-111157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.58 |
#
|
|
Separation and General Release Agreement, dated as of
December 23, 2010, by and between the Registrant and
Jean-Pierre Sommadossi
|
|
8-K
|
|
|
10.1 |
|
|
12/30/2010
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.59 |
#
|
|
Employment Letter, dated December 1, 2010, by and
between the Registrant and Ronald C. Renaud, Jr.
|
|
8-K
|
|
|
10.1 |
|
|
12/6/2010
|
|
000-49839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.60 |
#
|
|
Employment Letter, dated December 8, 2010, by and
between the Registrant and Douglas L. Mayers, M.D.
|
|
* |
|
|
|
|
|
|
|
|
88
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporated by Reference to |
Exhibit |
|
|
|
|
|
Exhibit |
|
Filing |
|
SEC |
Number |
|
Description |
|
Form |
|
No. |
|
Date |
|
File Number |
|
|
|
|
|
|
|
|
|
|
|
|
10.61 |
#
|
|
Employment Letter,
dated December 9,
2010, by and between
the Registrant and
David N. Standring,
PH.D.
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.62 |
#
|
|
Employment Letter,
dated November 30,
2010, by and between
the Registrant and
Maria Stahl
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional Exhibits |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21.1
|
|
|
Subsidiaries of the Company |
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23.1
|
|
|
Consent of
PricewaterhouseCoopers
LLP, an independent
registered public
accounting firm
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.1
|
|
|
Certification of Chief
Executive Officer
pursuant to Rule
13a-14(a)/15d-14(a) of
the Securities
Exchange Act of 1934,
as amended
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.2
|
|
|
Certification of
Interim Chief
Financial Officer
pursuant to Rule
13a-14(a)/15d-14(a) of
the Securities
Exchange Act of 1934,
as amended
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.1
|
|
|
Certification of Chief
Executive Officer
pursuant to 18 U.S.C.
§1350, as adopted
pursuant to Section
906 of the
Sarbanes-Oxley Act of
2002
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.2
|
|
|
Certification of
Interim Chief
Financial Officer
pursuant to 18 U.S.C.
§1350, as adopted
pursuant to Section
906 of the
Sarbanes-Oxley Act of
2002
|
|
* |
|
|
|
|
|
|
|
|
|
* |
|
Filed herewith |
|
# |
|
Management contract or compensatory plan or arrangement filed as an exhibit to this report
pursuant to Items 15(a) and 15(c) of Form 10-K |
|
+ |
|
Confidential treatment requested as to certain portions, which portions have been separately
filed with the Securities and Exchange Commission |
89