EXHIBIT 99.1
POZEN Reports First Quarter 2004 Results
CHAPEL HILL, N.C.--(BUSINESS WIRE)--xx--POZEN Inc. (NASDAQ: POZN),
today announced results for the first quarter ended March 31, 2004.
POZEN reported a net loss of $2.4 million, or $0.08 per share, for
the first quarter of 2004 compared with a net loss of $4.8 million, or
$0.17 per share, for the first quarter of 2003.
For the first quarter of 2004, POZEN reported revenue of $1.9
million. POZEN did not report any revenue for the first quarter of
2003. Revenue for the first quarter ended March 31, 2004, resulted
from the amortization of payments received in 2003 under the licensing
agreements for MT 100(TM), MT 300(TM), and MT 400(TM).
Total operating expenses for the first quarter of 2004 were $4.4
million as compared to $5.0 million for the same period in 2003. The
decrease in operating expenses was due primarily to a reduced level of
research and development activities for MT 100 and MT 300.
At March 31, 2004, cash and cash equivalents totaled $56.6 million
compared to $60.5 million at December 31, 2003.
Business Highlights
In January 2004, POZEN announced the results of a two-year rat
carcinogenicity study for MT 100. The Company believes the results of
the study provided no evidence that the concomitant administration of
maximum tolerated doses of metoclopramide and naproxen produced any
statistically significant differences in the occurrences and types of
tumors from those seen with metoclopramide alone. None of the tumors
observed in the study were considered to have been caused directly by
the administration of metoclopramide; all were considered to have been
caused by the chronic elevation of the hormone prolactin resulting
from administration of metoclopramide. The study report was submitted
to the U.S. Food and Drug Administration (FDA) and completes the MT
100 New Drug Application (NDA) made by POZEN in July 2003. The NDA was
accepted for filing by the FDA in October 2003 and is currently in
review. MT 100 is being developed as a preferred prescription therapy
for the acute treatment of migraine.
In March 2004, POZEN submitted a response to the FDA's
not-approvable letter for MT 300 and was notified in April 2004 that
the FDA considered the response incomplete because it did not include
sufficient information responsive to a question regarding the testing
procedures in the manufacturing process for MT 300. POZEN plans to
submit the additional information during the second quarter of 2004.
MT 300 is being developed as a new formulation of dihydroergotamine
mesylate(DHE) in a pre-filled syringe for the acute treatment of
migraine.
Financial Guidance
For the second quarter of 2004, POZEN expects total revenue
resulting from amortization of deferred revenue to be approximately
$1.9 million. POZEN expects total operating expenses for the second
quarter of 2004 to be in the range of $6.5 million to $7.5 million.
For the 2004 year, POZEN expects total revenue from existing
licensing agreements to be in the range of $23 million to $25 million.
POZEN expects total operating expenses for the 2004 year to be in the
range of $30 million to $34 million. These estimates of revenue and
expenses reflect the expected commencement of Phase III clinical
trials for MT 400 in 2004.
First-Quarter Results Webcast
POZEN will hold a webcast to present first-quarter results and
management's outlook on Thursday, April 29, 2004 at 11:00 a.m. Eastern
time. The webcast can be accessed live and will be available for
replay over the Internet at www.pozen.com.
About POZEN
POZEN is a pharmaceutical company committed to developing
therapeutic advancements for diseases with unmet medical needs where
it can improve efficacy, safety, and/or patient convenience. Since its
inception, POZEN has developed what it believes to be one of the
largest and most advanced product pipelines in the field of migraine.
POZEN has development and commercial alliances with GlaxoSmithKline,
Xcel Pharmaceuticals, 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/or FDA approval, or the
failure to obtain such approval of our product candidates;
uncertainties in clinical trial results or the timing of such trials,
resulting in, among other things, an extension in the period over
which we recognize deferred revenue or 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 Annual Report on
Form 10-K for the year ended December 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.
POZEN Inc.
Statement of Operations
(Unaudited)
Three Months Ended
March 31,
----------------------------
2004 2003
----------------------------
Revenue:
Licensing revenue $ 1,889,500 $ --
Operating expenses:
General and administrative 1,998,049 1,863,151
Research and development 2,371,967 3,112,864
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Total operating expenses 4,370,016 4,976,015
Other Income:
Interest income 126,150 143,269
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Net loss attributable to common
stockholders $ (2,354,366) $(4,832,746)
============= ===========
Basic and diluted net loss per common
share $ (0.08) $ (0.17)
============= ===========
Shares used in computing basic and
diluted net loss per common share 28,555,654 28,150,319
============= ===========
POZEN Inc.
Balance Sheet
(Unaudited)
March 31, December 31,
2004 2003
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ASSETS
Current assets:
Cash and cash equivalents $56,574,373 $ 60,480,690
Prepaid expenses and other current assets 664,150 698,209
----------- ------------
Total current assets 57,238,523 61,178,899
Equipment, net of accumulated depreciation 310,505 334,096
----------- ------------
Total assets $57,549,028 $ 61,512,995
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 590,879 $ 579,903
Accrued expenses 1,180,258 1,519,675
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Total current liabilities 1,771,137 2,099,578
Long-term liabilities:
Deferred revenue 21,893,478 23,782,978
----------- ------------
Total liabilities 23,664,615 25,882,556
Total stockholders' equity 33,884,413 35,630,439
----------- ------------
Total liabilities and stockholders'
equity $57,549,028 $ 61,512,995
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CONTACT: POZEN Inc.
Lisa Barthelemy
Director, Investor Relations, 919-913-1044
John Barnhardt
Vice President, Finance and Administration, 919-913-1030