Attached files
| file | filename |
|---|---|
| 8-K - BIOMIMETIC THERAPEUTICS, INC. | v177133_8k.htm |
| EX-99.3 - BIOMIMETIC THERAPEUTICS, INC. | v177133_ex99-3.htm |
| EX-99.2 - BIOMIMETIC THERAPEUTICS, INC. | v177133_ex99-2.htm |
Exhibit
99.1
Contact:
Kearstin
Patterson
Director,
Corporate Communications
615-236-4419
(office)
615-517-6112
(mobile)
kpatterson@biomimetics.com
BioMimetic
Therapeutics Reports 2009 Fourth Quarter and
Year
End Earnings Results
Additional
Pivotal Clinical Data Presented at AAOS Demonstrates Comparable Clinical,
Functional and Radiologic Outcomes and Improved Safety in Augment Patients
Compared to Patients Treated With Autograft
Franklin, Tenn. – March 11,
2010 – BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its
financial results as of and for the three and twelve months ended December 31,
2009. For the three months ended December 31, 2009, the Company
reported a net income of $1.1 million, or $0.05 per diluted share, compared to a
net loss of $12.2 million, or $0.65 per diluted share, for the same period in
2008. For the twelve months ended December 31, 2009, the Company
reported a net loss of $21.2 million, or $1.03 per diluted share, compared to a
net loss of $8.0 million, or $0.43 per diluted share, for the same period in
2008. The Company ended the year with $75.1 million of cash and cash
equivalents and investments.
Presentation
of Additional Phase III Pivotal Study Data
The lead
investigator for the Augment™ Bone Graft North American pivotal clinical trial,
Dr. Christopher DiGiovanni, professor and chief, division of foot and ankle
surgery at The Warren Albert School of Medicine presented additional data from
the pivotal human clinical study during the American Academy of Orthopedic
Surgeons (AAOS) meeting. Highlights of the additional results have
been summarized and presented in table form below. These data are based on the
“modified intent-to-treat” (mITT) patient population, which is the pre-specified
primary study population. The results are shown for the full
complement of joints in which all treated joints within a patient must meet the
success criteria as well as on an individual joint basis in which each treated
joint is scored separately.
|
Augment™
Bone Graft
(N=260)
|
Autologous
Bone Graft (N=137)
|
Non-inferiority
test p-value
|
||||||||||
|
Subjects
(N=397)
Individual
joints [All Joints] (N=597)
|
(N=260)
(N=394)
|
(N=137)
(N=203)
|
||||||||||
|
CT
Fusion Rates†
|
||||||||||||
|
Full
Complement of Joints:
|
61.2 | % | 62.0 | % | 0.038 | |||||||
|
All
Joints (assessed individually):
|
66.5 | % | 62.6 | % |
<0.001
|
|||||||
|
Clinical Healing
(Physician Evaluation)
|
||||||||||||
|
Patient Level:†
|
83.1 | % | 83.9 | % | 0.010 | |||||||
|
Full
Complement of Joints:
|
82.3 | % | 83.2 | % | 0.011 | |||||||
|
All
Joints (assessed individually):
|
83.5 | % | 83.3 | % |
<0.001
|
|||||||
|
Non-union/delayed
union:†
|
8.8 | % | 10.2 | % | 0.008 | |||||||
|
Plain Film
Radiographic Union Rates (3 Aspects)
|
||||||||||||
|
Full
Complement of Joints:
|
30.8 | % | 32.8 | % | 0.054 | |||||||
|
All
Joints (assessed individually):
|
38.3 | % | 37.9 | % | 0.007 | |||||||
|
|
||||||||||||
|
Plain Film
Radiographic Union Rates (2 Aspects)
|
||||||||||||
|
Full
Complement of Joints:
|
60.8 | % | 66.4 | % | 0.194 | |||||||
|
All
Joints (assessed individually):
|
67.5 | % | 70.9 | % | 0.049 | |||||||
|
|
||||||||||||
|
Clinical Healing
(Aggregate Measures)
|
||||||||||||
|
Composite
Success Rate:
|
66.9 | % | 66.4 | % | 0.017 | |||||||
|
Clinical
Success Rate:
|
74.6 | % | 78.1 | % | 0.071 | |||||||
|
Therapeutic
Failure:
|
9.2 | % | 10.9 | % |
<0.001
|
|||||||
|
|
||||||||||||
|
Functional/QoL
|
||||||||||||
|
SF-12
Mean PCS:
|
39.9 | 41.4 |
<0.001
|
|||||||||
|
FFI
Mean Total Score:
|
27.4 | 22.3 | 0.012 | |||||||||
|
AOFAS
Mean Total Score:
|
73.9 | 75.9 |
<0.001
|
|||||||||
|
|
||||||||||||
|
Pain
|
||||||||||||
|
Fusion
Site Pain:
|
18.9 | 16.5 | 0.001 | |||||||||
|
Weight-bearing
Pain:
|
23.5 | 19.3 | 0.016 | |||||||||
|
Graft
Harvest Site Pain:
|
n/a | 8.1 |
<0.001
|
|||||||||
|
|
||||||||||||
Therapeutic
failures are patients who were assessed as having non-union or delayed union at
24 weeks, or required secondary therapeutic intervention for non-union or
delayed union
Composite
Success represents a pre-specified combination of radiographic, clinical and
functional measures
Clinical
Success is defined as improvement in pain from baseline with no need for
revision surgery
†
Indicates previously reported data
Secondary endpoints not previously
reported included additional radiographic (Plain Film Union for 2 and 3
aspects), clinical (Clinical Healing by joint, Composite Success, Clinical
Success, Therapeutic Failure), functional (SF-12, Foot Function Index, AOFAS
scores) and patient indicated pain (Fusion Site, Weight-Bearing, Graft Harvest
Site) evaluations. Out of a total of 15 additional secondary endpoints, twelve
met the test for non-inferiority at a statistically significant
level.
New data were also reported relating to
the safety of Augment compared to the autograft control. The Augment
group exhibited a lower rate of serious treatment emergent adverse events, a
lower rate of overall and surgery-related complications, a lower rate of serious
complications, fewer surgery-related complications and a lower rate of infection
when compared with the autograft group. A summary of the key safety results for
all treated
patients is presented
below. P-values
greater than 0.05 indicate that the treatments are not statistically
different.
2
|
Augment™
Bone Graft (N=272)
|
Autologous
Bone Graft (N=142)
|
Fisher
Exact Test p-value
|
|
|
Pre-Treatment
Signs and Symptoms
|
3.7%
|
2.8%
|
p=0.779
|
|
Treatment
Emergent Adverse Events (TEAE)
|
72.4%
|
70.4%
|
p=0.730
|
|
Serious
Treatment Emergent Adverse Events (TEAE)
|
7.7%
|
14.1%
|
p=0.055
|
|
Overall
complications
|
33.5%
|
38.0%
|
p=0.386
|
|
Complications
associated with surgical procedure
|
23.5%
|
29.6%
|
p=0.193
|
|
Serious
complications
|
4.4%
|
6.3%
|
p=0.480
|
|
Serious
surgical complications
|
4.0%
|
6.3%
|
p=0.337
|
|
Infections†
|
7.7%
|
9.9%
|
p=0.462
|
† Indicates previously reported
data
“We have
now seen the full 24 week data set and believe it demonstrates that Augment is
as effective as autograft for these fusion indications, while having the
advantage of reducing serious complications from the
procedure. Moreover, the use of Augment has the additional benefit of
sparing patients the pain and potential morbidity resulting from an autograft
harvest surgery,” said Dr. Samuel Lynch, president and CEO of BioMimetic
Therapeutics. “The complete PMA is currently under review by the FDA,
and we look forward to the Orthopedic Advisory Panel meeting later this
year.”
2009
and Recent Product Development and Corporate Highlights
Augment
Bone Graft
|
|
·
|
The Company recently filed an application with the
Therapeutic Goods Administration (TGA) for approval of Augment in foot and
ankle fusion indications in Australia. BioMimetic submitted to TGA pivotal
trial data from both the Canadian and North American studies, which the Company expects will be suitable for approval in
Australia.
|
|
|
·
|
In
October 2009, the Company announced positive top-line results from
its North American pivotal (Phase III) randomized, controlled
trial comparing Augment to autograft for use in hindfoot and ankle fusion
surgery(see data tables above). The study goal was to establish
non-inferiority of Augment compared to autograft, which has the limitation
that it must be obtained and transplanted from another bone in the
patient’s body, often requiring a second surgical
procedure. These positive top-line results indicate that, with
the use of Augment, patients can expect a treatment outcome comparable to
autograft while being spared the pain and potential morbidity associated
with traditional autograft bone harvesting and
transplantation.
|
|
|
·
|
In February 2010, the Company
submitted to the FDA the third PMA module, which supplements the
pre-clinical pharmacology/toxicology and quality/manufacturing
modules submitted in the second quarter of 2009. This third PMA
module contains
the 24
week data from the
North American Augment pivotal trial, and completes our PMA seeking FDA
approval of Augment in the United
States.
|
|
|
·
|
In
November 2009, the Company announced that it received approval from Health
Canada to begin the marketing of its lead orthopedic product, Augment, as
an alternative to the use of autograft in foot and ankle fusion
indications in Canada. Clinical specialists were deployed in
the Canadian market, which is approximately 5% the size of the U.S.
market, to work collaboratively with the Joint Solutions team, the
exclusive distributor of the Augment product in Canada. The
product was made available to customers in Canada in January
2010. The Company is working with distributor personnel to gain
product approval at individual institutions through review by the
hospitals’ new product evaluation committees, a process that can take
several months to complete.
|
3
|
|
·
|
In
November 2008, the Company completed enrollment in the EU clinical study
with Augment for the treatment of foot and ankle fusions with a total
enrollment of 108 patients. The Company is compiling the data from
the study and anticipates it will be available around mid-year
2010. The Company expects to submit the trial data, in
conjunction with data from the North American pivotal trial, to European
regulatory authorities in the third quarter of this
year.
|
Augment
Injectable™ Bone Graft
|
|
·
|
In
the fourth quarter of 2009, the Company initiated Canadian patient
enrollment in the North American pivotal study to assess the safety and
efficacy of Augment Injectable Bone Graft as a substitute for autograft in
foot and ankle fusion procedures. This randomized, controlled
study is intended to support Augment Injectable product registration in
the United States and Canada.
|
|
|
·
|
The
Company is finalizing the details of the protocol and the statistical plan
of the Augment Injectable North American pivotal study with the FDA and
will not begin patient enrollment in the United States until the details
of the protocol and the statistical plan are complete. The
Company expects to receive a final decision on its IDE around the middle
of 2010 and anticipates initiating patient enrollment in the United States
shortly thereafter.
|
Sports
Medicine
|
|
·
|
At
the Orthopedic Research Society meeting in March 2010, the Company’s
sports medicine team presented results of two pre-clinical studies
demonstrating that rhPDGF-BB, in combination with tissue specific matrix
materials, promotes healing in Achilles and rotator cuff injuries in sheep
models. In addition, in vitro data supporting rhPDGF-BB’s
ability to influence tenocytes was also presented. Based on
these positive results, the Company intends to initiate a pilot clinical
trial in sports medicine by the end of this
year.
|
Corporate
|
|
·
|
In December 2009, the Company sold
all of the remaining auction-rate securities (ARS) at issue in an
arbitration proceeding which the Company filed in
February 2009 with the Financial Industry Regulatory Authority, Inc.
(FINRA). In addition, following receipt of
a payment in the amount of $7.2 million from the respondent in the
arbitration, BioMimetic settled the arbitration claim and dismissed the
case. With the redemptions and sales of all remaining ARS
investments during 2009, BioMimetic repaid in full the balance on its time
promissory note credit facility, under which the Company had borrowed
$39.1 million in October 2008.
|
|
|
·
|
In December 2009, the Company amended and restated
its manufacturing and supply agreement with Novartis Vaccines and
Diagnostics, Inc. for the supply of bulk rhPDGF-BB to
BioMimetic. The agreement strengthens the mutual exclusivity whereby
Novartis shall manufacture rhPDGF-BB exclusively for BioMimetic for
therapeutic applications covering bone, cartilage, tendon and
ligaments.
|
|
|
·
|
The Company announced in January 2010
that the European Patent Office (EPO) intends to grant patent application
No. 05803356 titled “Platelet-Derived Growth Factor Compositions and
Methods of Use Thereof”. The allowed claims will cover compositions of platelet
derived growth factor (PDGF) combined with matrix materials having defined
characteristics, which will cover the Company’s novel
recombinant protein-device combination product candidates, including
Augment and Augment Injectable, as well as GEMESIS™, which the Company previously
sold to Luitpold Pharmaceuticals, Inc. After the new patent is formally issued, it will provide protection against
the marketing of similar or generic versions of Augment, Augment
Injectable, and GEMESIS in Europe until 2025.
|
4
“During
2009 and the beginning of 2010 we have made strong progress in the advancement
of BioMimetic as a premier company in the orthobiologics space,” continued Dr.
Lynch. “We have submitted our Augment PMA to the FDA and believe the clinical
data, pre-clinical pharmacology/toxicology and quality/manufacturing modules
comprise a very strong package. We are working toward marketing
approvals for Augment in Australia and Europe. We’ve also advanced
our Augment Injectable product candidate into a pivotal clinical trial and are
encouraged by the pre-clinical data that we recently reported in the sports
medicine area. Lastly, we were able to reach a satisfactory conclusion on our
remaining auction-rate securities helping to strengthen our balance sheet prior
to commercialization of Augment. We have high expectations for 2010 and look
forward to meeting our upcoming milestones and creating even more value for our
shareholders and customers.”
Additional
Financial Results
As of
December 31, 2009, the Company had approximately $21.6 million of cash and cash
equivalents and $53.5 million of investments in U.S. government sponsored
enterprise (“GSE”) securities and U.S. Treasury Notes. During the
twelve months ended December 31, 2009, all of the Company’s investments in
auction rate securities were sold at a discount or redeemed by the issuers at
par, resulting in total cash proceeds of $52.4 million and a $5.8 million
realized gain recorded to earnings on the Company’s consolidated statement of
operations as of December 31, 2009. In addition, in December 2009,
the Company received a $7.2 million payment from the settlement of an
arbitration claim relating to the investments in ARS made on its
behalf. With the sales and redemptions of all its ARS investments,
the Company has repaid in full the balance on its Time Promissory Note (“Note”)
and the original promissory note has been returned to the Company marked “paid
in full.” In addition, the issuer of the Note has released the Company
from the Note, and has terminated the Company’s security and pledge agreement
and securities account control agreement and terminated any UCC filings made
with respect to the Note and security agreements.
The net
loss for the twelve months ended December 31, 2009 includes a $5.8 million
realized gain on investments and a $7.2 million gain on arbitration settlement,
both of which are related to the Company’s investments in auction rate
securities previously held. Comparatively, the net loss for the
twelve months ended December 31, 2008 included a $13.4 million non-cash
impairment charge on the Company’s investments in auction rate securities and a
$39.3 million gain resulting from the January 2008 sale of the Company’s
orofacial therapeutic business. Excluding these items, the Company’s
net loss for the twelve months ended December 31, 2009 and 2008 would have been
$34.2 million, or $1.67 per diluted share, and $33.9 million, or $1.83 per
diluted share, respectively.
For the
three and twelve months ended December 31, 2009, the Company reported total
revenues of $0.4 million and $1.6 million, respectively, consisting of product
sales, royalty income and sublicense fee income. Product sales
revenues of $0.1 million were recorded in December 2009 based on the Company’s
December 2009 shipment of Augment to Joint Solutions in
Canada. Comparatively, total revenues were $1.8 million and $3.1
million, respectively, for the same periods in 2008, which includes $1.6 million
of royalty income recorded in December 2008 based on a reimbursement received in
2008 for minimum royalty expenses that were contractually paid by the Company to
independent third parties. There was no minimum royalty expense or reimbursement
in 2009.
Research
and development expenses totaled $5.6 million for the three months ended
December 31, 2009, compared to $5.9 million for the same period in
2008. For the twelve months ended December 31, 2009, research and
development expenses totaled $21.1 million, compared to $24.6 million for the
same period in 2008. Research and development expenses result
primarily from clinical trials of the Company’s orthopedic product candidates in
the United States, Canada and the European Union, as well as continuing expenses
associated with new and ongoing pre-clinical studies and regulatory
filings. The decrease in 2009 research and development expenses was
partially due to contract manufacturing costs, which decreased by $0.1 million
and $1.8 million, respectively, for the three and twelve months ended December
31, 2009, since certain clinical trials came to a close in 2009. In
addition, professional services costs for clinical, validation consulting,
regulatory and outside research and development, milestone expenses, salary
& benefits and recruiting and relocation costs decreased by approximately
$0.3 million and $1.7 million, respectively, for the three and twelve months
ended December 31, 2009.
5
General
and administrative expenses totaled $4.0 million for the three months ended
December 31, 2009, compared to $4.2 million for the same period in
2008. For the twelve months ended December 31, 2009, general and
administrative expenses totaled $11.5 million, compared to $11.3 million for the
same period in 2008. The increase in 2009 general and administrative
expenses resulted primarily from increases in salaries, wages and related
benefits, professional services and legal fees, as well as rent, utility and
maintenance costs for the Company’s facilities, offset partially by a $1.8
million decrease in royalty expense resulting from minimum royalty expenses
contractually paid by the Company in 2008 to independent third
parties. There were no minimum royalty expenses in 2009.
2010
Financial Guidance
Based on
current operating plans, forecasted timing and costs of clinical trials and
other product development programs, the Company anticipates its 2010 year-end
balance of cash, cash equivalents and investments to range from $36.0 to $43.0
million, and anticipates that its net cash use will be between $32.0 and $39.0
million. Net loss for the year ending December 31, 2010 is forecasted
to be in the range of $36.0 to $43.0 million.
Conference
Call and Webcast
As
previously announced, BioMimetic will be hosting a conference call and webcast
on Friday, March 12, 2010 at 8:30 a.m. EST to discuss the fourth quarter and
year end 2009 financial results. A live webcast of the conference
call will be available on the Investor Relations section of BioMimetic’s website
at www.biomimetics.com. The
webcast will be archived on the website for at least 30 days.
The
conference call may be accessed on March 12, 2010 by dialing (877) 224-4059
(passcode: 58839507) for U.S. and Canada. The international dial in
number is (706) 902-2069, and the same passcode
applies. Participants should dial in 10 minutes prior to the
call.
About BioMimetic
Therapeutics
BioMimetic
Therapeutics is a biotechnology company utilizing purified recombinant
human platelet-derived growth factor (rhPDGF-BB) in combination with tissue
specific matrices as its primary technology platform for promotion of tissue
healing and regeneration. rhPDGF-BB is a synthetic form of one of the
body's principal agents to stimulate and direct healing and regeneration.
The mechanism of action of this platform technology suggests it may be effective
in a broad array of musculoskeletal applications, including the repair of bone,
ligament, tendon and cartilage. Through the commercialization of this
technology, BioMimetic seeks to become the leading company in the field of
orthopedic regenerative medicine. In 2005, BioMimetic received marketing
approval from the FDA for its first product, GEM 21S®, as a grafting
material for bone and periodontal regeneration. Additionally, BioMimetic
Therapeutics has completed and ongoing clinical trials with its product
candidates Augment™ Bone Graft and Augment™ Injectable in multiple orthopedic
bone healing indications including the treatment of foot and ankle fusions and
the stimulation of healing of fractures of the wrist. In November
2009, BioMimetic received approval from Health Canada to begin marketing Augment
as an alternative to the use of autograft in foot and ankle fusion indications
in Canada. In February 2010, the Company submitted its Pre-Marketing Approval
(PMA) application to the FDA for the approval of Augment Bone
Graft.
6
GEM 21S is a trademark of
Luitpold Pharmaceuticals, Inc., who now owns this dental related product and
markets it through its Osteohealth Company in the United States and
Canada.
For further information, visit
www.biomimetics.com or contact Kearstin Patterson, corporate
communications, at 615-236-4419.
Forward-looking
Statements
This
press release contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements are based on the current intent and expectations of the management of
BioMimetic. These statements are not guarantees of future performance and
involve risks and uncertainties that are difficult to predict. There
are many important factors that could cause actual results to differ materially
from those indicated in the forward-looking statements. BioMimetic’s
actual results and the timing and outcome of events may differ materially from
those expressed in or implied by the forward-looking statements because of risks
associated with the marketing of BioMimetic’s product and product candidates,
unproven preclinical and clinical development activities, regulatory oversight,
and other risks detailed in BioMimetic’s filings with the Securities and
Exchange Commission. Except as required by law, BioMimetic undertakes no
responsibility for updating the information contained in this press release
beyond the published date, whether as a result of new information, future events
or otherwise, or for changes made to this document by wire services or Internet
services.
###
7
|
BIOMIMETIC THERAPEUTICS,
INC.
|
||||||||
|
CONSOLIDATED BALANCE
SHEETS
|
||||||||
|
December
31,
|
||||||||
|
2009
|
2008
|
|||||||
|
ASSETS
|
||||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents
|
$ | 21,543,347 | $ | 17,534,963 | ||||
|
Investments
- short term
|
47,001,504 | 33,218,233 | ||||||
|
Receivables
- trade
|
78,000 | 1,084 | ||||||
|
Receivables
- other
|
612,020 | 11,635,778 | ||||||
|
Inventory
|
1,044,305 | - | ||||||
|
Prepaid
expenses
|
647,156 | 503,032 | ||||||
|
Total
current assets
|
70,926,332 | 62,893,090 | ||||||
|
Investments
- long term
|
6,513,975 | 46,624,040 | ||||||
|
Inventory
|
- | 1,261,987 | ||||||
|
Prepaid
expenses - long term
|
5,418 | 58,673 | ||||||
|
Property
and equipment, net
|
8,156,842 | 7,014,262 | ||||||
|
Capitalized
patent license fees, net
|
2,924,614 | 4,983,729 | ||||||
|
Deposits
|
385,000 | 2,284,608 | ||||||
|
Total
assets
|
$ | 88,912,181 | $ | 125,120,389 | ||||
|
|
||||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 2,255,748 | $ | 4,325,907 | ||||
|
Accrued
payroll, employee benefits and payroll taxes
|
2,299,237 | 2,304,016 | ||||||
|
Other
accrued expenses
|
135,070 | 2,392,236 | ||||||
|
Current
portion of capital lease obligations
|
56,520 | 18,187 | ||||||
|
Deferred
revenue
|
971,188 | 971,188 | ||||||
|
Total
current liabilities
|
5,717,763 | 10,011,534 | ||||||
|
Accrued
rent - related party
|
418,305 | 399,256 | ||||||
|
Capital
lease obligations
|
174,818 | 34,713 | ||||||
|
Deferred
revenue
|
15,549,678 | 16,520,866 | ||||||
|
Note
payable
|
- | 39,100,000 | ||||||
|
Total
liabilities
|
21,860,564 | 66,066,369 | ||||||
|
|
||||||||
|
Stockholders’
equity:
|
||||||||
|
Preferred
stock, $0.001 par value; 15,000,000 shares authorized;
|
||||||||
|
no
shares issued and outstanding as of December 31, 2009 and
2008
|
- | - | ||||||
|
Common
stock, $0.001 par value; 37,500,000 shares authorized;
|
||||||||
|
21,825,028
shares issued and outstanding as of December 31, 2009;
|
||||||||
|
18,714,067
shares issued and outstanding as of December 31, 2008
|
21,825 | 18,714 | ||||||
|
Additional
paid-in capital
|
160,532,625 | 131,262,570 | ||||||
|
Accumulated
other comprehensive income
|
17,387 | 135,542 | ||||||
|
Accumulated
deficit
|
(93,520,220 | ) | (72,362,806 | ) | ||||
|
Total
stockholders’ equity
|
67,051,617 | 59,054,020 | ||||||
|
Total
liabilities and stockholders’ equity
|
$ | 88,912,181 | $ | 125,120,389 | ||||
8
|
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS
|
||||||||||||||||
|
(Unaudited)
|
||||||||||||||||
|
Three
months ended
|
Twelve
months ended
|
|||||||||||||||
|
December
31,
|
December
31,
|
|||||||||||||||
|
2009
|
2008
|
2009
|
2008
|
|||||||||||||
|
Revenues:
|
||||||||||||||||
|
Product
sales
|
$ | 78,000 | $ | - | $ | 78,000 | $ | - | ||||||||
|
Royalty
income
|
121,927 | 1,539,222 | 522,038 | 2,144,234 | ||||||||||||
|
Sublicense
fee income
|
244,792 | 244,793 | 971,188 | 973,849 | ||||||||||||
|
Other
revenue
|
- | - | - | 30,301 | ||||||||||||
|
Total
revenues
|
444,719 | 1,784,015 | 1,571,226 | 3,148,384 | ||||||||||||
|
Costs
and expenses:
|
||||||||||||||||
|
Cost
of sales (exclusive of depreciation and
|
||||||||||||||||
|
amortization
shown separately below)
|
5,666 | - | 5,666 | - | ||||||||||||
|
Research
and development
|
5,557,345 | 5,929,895 | 21,095,429 | 24,560,975 | ||||||||||||
|
General
and administrative
|
3,977,296 | 4,196,231 | 11,511,619 | 11,252,445 | ||||||||||||
|
Depreciation
and capital lease amortization
|
317,457 | 356,132 | 1,332,881 | 1,423,341 | ||||||||||||
|
Patent
license fee amortization
|
550,715 | 765,031 | 2,569,159 | 2,663,299 | ||||||||||||
|
Total
costs and expenses
|
10,408,479 | 11,247,289 | 36,514,754 | 39,900,060 | ||||||||||||
|
Loss
from operations
|
(9,963,760 | ) | (9,463,274 | ) | (34,943,528 | ) | (36,751,676 | ) | ||||||||
|
Interest
(expense) income, net
|
(43,828 | ) | (180,592 | ) | (308,127 | ) | 247,134 | |||||||||
|
Investment
income (loss), net
|
3,872,180 | (2,646,140 | ) | 6,863,834 | (10,796,893 | ) | ||||||||||
|
Gain
on disposal of equipment and other
|
11,137 | - | 11,137 | 5,025 | ||||||||||||
|
Gain
on arbitration settlement
|
7,219,270 | - | 7,219,270 | - | ||||||||||||
|
Gain
on disposal of orofacial therapeutic business
|
- | 99 | - | 39,291,413 | ||||||||||||
|
Income
(loss) before income taxes
|
1,094,999 | (12,289,907 | ) | (21,157,414 | ) | (8,004,997 | ) | |||||||||
|
Income
taxes
|
- | (122,500 | ) | - | - | |||||||||||
|
Net
income (loss)
|
$ | 1,094,999 | $ | (12,167,407 | ) | $ | (21,157,414 | ) | $ | (8,004,997 | ) | |||||
|
Net
income (loss) per common share:
|
||||||||||||||||
|
Basic
|
$ | 0.05 | $ | (0.65 | ) | $ | (1.03 | ) | $ | (0.43 | ) | |||||
|
Diluted
|
$ | 0.05 | $ | (0.65 | ) | $ | (1.03 | ) | $ | (0.43 | ) | |||||
|
Weighted
average shares used to compute
|
||||||||||||||||
|
net income (loss) per common share:
|
||||||||||||||||
|
Basic
|
21,794,645 | 18,671,073 | 20,510,132 | 18,529,068 | ||||||||||||
|
Diluted
|
22,532,128 | 18,671,073 | 20,510,132 | 18,529,068 | ||||||||||||
9