Exhibit 99.1
POZEN Reports Second Quarter Results
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 5, 2003--POZEN Inc.
(NASDAQ:POZN), a pharmaceutical company developing therapeutic
advancements in a cost effective manner, today announced results for
the second quarter ended June 30, 2003.
Second-Quarter Results
POZEN is a development-stage company that did not record revenues
for the second quarter of 2003 or 2002.
For the second quarter of 2003, the company reported total
operating expenses of $4.8 million compared to $6.9 million in the
second quarter of 2002. Operating expenses excluding the non-cash
amortization of deferred compensation were $4.7 million in the second
quarter of 2003 compared to $6.2 million in the second quarter of
2002. The non-cash amortization of deferred compensation in connection
with employee stock option grants was $143,000 and $736,000 for the
2003 and 2002 three-month periods, respectively. The 2003 second
quarter decrease in operating expenses was due primarily to a reduced
level of research and development activities for MT 300 and MT 400,
offset by an increase in costs associated with the licensing of MT 400
and pre-marketing activities for MT 100 and MT 300.
POZEN's net loss attributable to common stockholders was $4.7
million, or $0.17 per common share, for the quarter ended June 30,
2003 compared to $6.6 million, or $0.24 per common share, for the 2002
quarter. At June 30, 2003, the company had approximately $42 million
in cash and cash equivalents.
Six Month Results
POZEN is a development-stage company that did not record revenues
for the six months ended June 30, 2003 or during 2002.
For the first six months of 2003, the company reported total
operating expenses of $9.8 million compared to $14.2 million for the
same period of 2002. Operating expenses excluding the non-cash
amortization of deferred compensation were $9.4 million compared to
$12.7 million for the same period of 2002. The non-cash amortization
of deferred compensation in connection with employee stock option
grants was $422,000 and $1.5 million for the 2003 and 2002 six-month
periods, respectively. The decrease in operating expenses was due
primarily to a reduced level of research and development activities
for MT 100, MT 300, and MT 400, offset by an increase in costs
associated with the licensing of MT 400 and pre-marketing activities
for MT 100 and MT 300.
POZEN's net loss attributable to common stockholders was $9.5
million, or $0.34 per common share, for the six-month period ended
June 30, 2003 as compared to $13.6 million, or $0.49 per common share,
for the same period of 2002.
Business Highlights
POZEN submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) in July 2003 for MT 100. The FDA has agreed
to review the NDA and accept POZEN's filing of the results of the rat
carcinogenicity study in early 2004. MT 100 is being developed as an
oral first-line therapy for the treatment of migraine.
In July 2003, POZEN and Nycomed announced that they signed a
licensing agreement to commercialize MT 100 in four Nordic countries -
Denmark, Sweden, Norway, and Finland. The Nordic countries account for
approximately 18% of the European triptan market on a Euro basis.
POZEN and GlaxoSmithKline (GSK) announced in June 2003 that they
signed an agreement for the development and commercialization of
proprietary combinations of a triptan and a long-acting non-steroidal
anti-inflammatory drug (NSAID) that may improve the effectiveness of
acute treatment and provide sustained relief for patients suffering
from migraine headaches. The combinations covered by the agreement are
among the combinations that POZEN has referred to as MT 400
technology. More recently, POZEN announced in July 2003, that the
waiting period required under the Hart-Scott-Rodino Antitrust
Improvements Act has expired, allowing the GSK and POZEN migraine
collaboration to proceed, and triggering POZEN's right to receive $25
million in initial payments by GSK, of which approximately $3.6
million will be recognized by POZEN as revenue in the second half of
2003.
POZEN strengthened its intellectual property position and
announced that it recently received a new patent in July 2003 for its
MT 400 technology. The patent provides additional claims relating to
pharmaceutical compositions and treatment methods that can be used for
migraine patients.
In an effort to expand into new therapeutic areas, POZEN announced
in July 2003 that it signed an exclusive option agreement with
Nycomed, under which POZEN may acquire a license to certain rights
related to lornoxicam, an NSAID. POZEN will explore the development of
novel product candidates containing lornoxicam alone or in combination
with other active ingredients for pain or other indications.
In June 2003, POZEN presented data at the American Headache
Society's 45th Annual Scientific Meeting. One of the presentations
highlighted data from a Phase III study, demonstrating that MT 300 is
effective in providing sustained pain relief for the acute treatment
of migraine. MT 300 is being developed as a new, improved formulation
of dihydroergotamine (DHE) in a convenient pre-filled syringe that is
suitable for at-home use.
"Over the last several months, we signed two major development and
commercialization deals with GSK and Nycomed for our novel migraine
product candidates, submitted an NDA for MT 100, and signed an
exclusive option agreement for lornoxicam, which may allow us to
broaden our portfolio of medicines and move into a new therapeutic
area," said John R. Plachetka, Pharm.D., chairman, president, and
chief executive officer of POZEN. "These achievements demonstrate our
ability to deliver and will drive growth for POZEN. I am extremely
proud of our team for their hard work and dedication."
Financial Guidance
For the third quarter of 2003, POZEN expects total revenue to be
approximately $1.8 million. POZEN expects total operating expenses for
the third quarter of 2003 to be in the range of $5.6 million to $6.6
million, including non-cash deferred compensation of $66,000.
For the 2003 year, POZEN expects total revenue to be approximately
$3.6 million. POZEN expects total operating expenses for the 2003 year
to be in the range of $19.5 million to $21.5 million, including
non-cash deferred compensation of $510,000.
Second-Quarter Results Conference Call
POZEN will hold a conference call to discuss second-quarter
results and management's outlook at 11:00 a.m. Eastern time on
Tuesday, August 5, 2003. The call can be accessed live and will be
available for replay over the Internet via www.pozen.com.
About POZEN
POZEN is a pharmaceutical company developing therapeutic
advancements in a cost effective manner. Since its inception, POZEN
has developed the largest and most advanced product pipeline in the
field of migraine. Product development efforts are focused on diseases
with unmet medical needs where POZEN can improve efficacy, safety,
and/or patient convenience. POZEN has development and commercial
alliances with GlaxoSmithKline and Nycomed. The company's common stock
is traded on The Nasdaq Stock Market under the symbol "POZN". For
detailed company information, including copies of this and other press
releases, see POZEN's website: www.pozen.com.
Statements included in this press release that are not historical
in nature are "forward-looking statements" within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are subject
to a number of risks and uncertainties, including, but not limited to,
our failure to successfully commercialize our product candidates;
costs and delays in the development and FDA approval of our product
candidates, resulting in, among other things, our failure to achieve
milestones that would have provided us with revenue; our inability to
maintain or enter into, and the risks resulting from our dependence
upon, collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and
distribution of any products; competitive factors; our inability to
protect our patents or proprietary rights and obtain necessary rights
to third party patents and intellectual property to operate our
business; our inability to operate our business without infringing the
patents and proprietary rights of others; general economic conditions;
the failure of any products to gain market acceptance; our inability
to obtain any additional required financing; technological changes;
government regulation; changes in industry practice; and one-time
events, including those discussed herein and in our Quarterly Report
on Form 10-Q for the quarterly period ended March 31, 2003 under
"Management's Discussion and Analysis of Financial Condition and
Results of Operations." We do not intend to update any of these
factors or to publicly announce the results of any revisions to these
forward-looking statements.
Financial Tables to Follow.
POZEN Inc.
Statement of Operations
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------ -------------------------
2003 2002 2003 2002
----------- ----------- ----------- ------------
Operating
expenses:
General and
administrative $ 2,921,052 $ 1,683,405 $ 4,784,203 $ 3,440,906
Research and
development 1,882,944 5,223,281 4,995,808 10,802,725
----------- ----------- ----------- ------------
Total operating
expenses 4,803,996 6,906,686 9,780,011 14,243,631
Interest income,
net 123,292 281,937 266,561 598,609
----------- ----------- ----------- ------------
Net loss
attributable to
common
stockholders $(4,680,704) $(6,624,749) $(9,513,450) $(13,645,022)
=========== =========== =========== ============
Basic and diluted
net loss per
common share $ (0.17) $ (0.24) $ (0.34) $ (0.49)
=========== =========== =========== ============
Shares used in
computing basic
and diluted net
loss per common
share 28,270,902 28,077,945 28,210,610 28,058,130
=========== =========== =========== ============
POZEN Inc.
Balance Sheet
(Unaudited)
June 30, December 31,
2003 2002
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 41,938,347 $ 50,056,251
Prepaid expenses and other current
assets 1,298,000 553,371
------------- -------------
Total current assets 43,236,347 50,609,622
Equipment, net of accumulated
depreciation 376,947 425,369
------------- -------------
Total assets $ 43,613,294 $ 51,034,991
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 403,033 $ 179,374
Accrued expenses 2,308,195 1,657,074
------------- -------------
Total current liabilities 2,711,228 1,836,448
Long-term liabilities:
Deferred revenue 500,000 -
------------- -------------
Total liabilities 3,211,228 1,836,448
Total stockholders' equity 40,402,066 49,198,543
------------- -------------
Total liabilities and stockholders'
equity $ 43,613,294 $ 51,034,991
============= =============
CONTACT: POZEN Inc., Chapel Hill
Matt Czajkowski, 919-913-1030
Chief Financial Officer
or
Lisa Barthelemy, 919-913-1044
Director, Investor Relations