Exhibit 99.1
POZEN Reports Fourth Quarter and Full-Year 2003 Results;
POZEN Books Revenue and Achieves Positive Cash Flow in 2003
Business Editors/Health/Medical Writers
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Feb. 18, 2004--POZEN Inc.
(NASDAQ: POZN), today announced results for the fourth quarter and
year ended December 31, 2003.
POZEN reported a net loss of $1.6 million, or $0.06 per share, for
the fourth quarter of 2003 compared with a net loss of $5.7 million,
or $0.20 per share, for the fourth quarter of 2002. POZEN's net loss
was $14.9 million, or $0.52 per common share for 2003, as compared to
$24.6 million or $0.87 per common share for 2002.
For the fourth quarter of 2003, POZEN reported revenue of $1.8
million. Revenue for the twelve months ended December 31, 2003 totaled
$3.7 million. POZEN did not report any revenue during 2002. Revenue
for the fourth quarter and the twelve months ended December 31, 2003,
resulted from the amortization of payments received under the
licensing agreements for MT 100(TM), MT 300(TM), and MT 400(TM).
Total operating expenses for the fourth quarter of 2003 were $3.6
million as compared to $5.9 million for the same period in 2002. The
decrease in operating expenses was due primarily to a reduced level of
research and development activities for MT 300 and MT 400. Operating
expenses for 2003 decreased 25% to $19.1 million. The decrease in
operating expenses for the year was due primarily to a reduced level
of research and development activities for MT 300 and MT 400, offset
by increased general and administrative costs. The non-cash
amortization of deferred compensation in connection with employee
stock option grants was $0.5 million and $2.9 million for 2003 and
2002, respectively.
At December 31, 2003, cash and cash equivalents totaled $60.5
million compared to $50.0 million at December 31, 2002. The increase
in cash and cash equivalents resulted primarily from positive net cash
provided by operating activities, or cash flow, for the year ended
December 31, 2003. POZEN received $27.5 million in cash in 2003 from
licensing agreements, of which $23.8 million will be recognized as
revenue in future periods.
"POZEN made considerable progress in 2003. We booked revenue and
achieved positive cash flow for the first time in our company history.
We submitted a New Drug Application for MT 100 and have secured
commercial partnerships for several product candidates," said John R.
Plachetka, Pharm.D., chairman, president and chief executive officer
of POZEN. "We look forward to an equally exciting 2004 as we move our
product candidates through development and the regulatory process,
continue to work on securing commercial partnerships, and introduce
new product candidates into our pipeline."
Business Highlights
MT 100
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 findings from those seen with
metoclopramide alone. None of the tumors observed in the study were
considered to be directly related to the administration of
metoclopramide or naproxen; all were considered to be secondary to
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 an oral first-line therapy for the acute
treatment of migraine.
In October 2003, POZEN announced that it received a letter of
comments from an advisory group to the Medicines and Healthcare
Products Regulatory Agency relating to the Marketing Authorization
Application for MT 100. POZEN plans to submit a response in the first
quarter of 2004, including providing additional support for the
benefits of the combination, to the comments raised by the advisory
group.
MT 300
In October 2003, POZEN announced that it received a not-approvable
letter from the FDA related to its NDA for MT 300. POZEN is committed
to working with the FDA and is preparing a complete response to
address the issues raised in the letter. MT 300 is being developed as
a new formulation of dihydroergotamine mesylate (DHE) in a prefilled
syringe for the acute treatment of migraine.
Financial Guidance
For the first 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 first
quarter of 2004 to be in the range of $4 million to $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 3 clinical trials
for MT 400 in 2004.
Fourth-Quarter Results Webcast
POZEN will hold a webcast to present fourth-quarter results and
management's outlook on Wednesday, February 18, 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 developing therapeutic
advancements in a cost effective manner. Product development efforts
are focused on diseases with unmet medical needs where POZEN can
improve efficacy, safety, and/or patient convenience. Since its
inception, POZEN has developed the largest and most advanced product
pipeline 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 Quarterly Report
on Form 10-Q for the quarterly period ended September 30, 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 Twelve Months Ended
December 31, December 31,
----------------------- -------------------------
2003 2002 2003 2002
----------------------- -------------------------
Revenue:
Licensing revenue $ 1,830,002 $ -- $ 3,717,000 $ --
Operating expenses:
General and
administrative 1,899,280 1,937,873 9,211,341 6,833,336
Research and
development 1,689,124 3,934,553 9,904,347 18,761,630
----------- ----------- ------------ ------------
Total operating
expenses 3,588,404 5,872,426 19,115,688 25,594,966
Other Income:
Interest income,
net 140,500 196,466 535,370 1,040,056
----------- ----------- ------------ ------------
Net loss attributable
to common
stockholders $(1,617,902)$(5,675,960)$(14,863,318)$(24,554,910)
=========== =========== ============ ============
Basic and diluted
net loss per
common share $ (0.06)$ (0.20)$ (0.52)$ (0.87)
=========== =========== ============ ============
Shares used in
computing basic and
diluted net loss
per common share 28,489,043 28,131,485 28,414,020 28,110,352
=========== =========== ============ ============
POZEN Inc.
Balance Sheet
(Unaudited)
December 31, December 31,
2003 2002
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 60,480,690 $ 50,056,251
Prepaid expenses and other current assets 698,209 553,371
------------- -------------
Total current assets 61,178,899 50,609,622
Equipment, net of accumulated depreciation 334,096 425,369
------------- -------------
Total assets $ 61,512,995 $ 51,034,991
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 579,903 $ 179,374
Accrued expenses 1,519,675 1,657,074
------------- -------------
Total current liabilities 2,099,578 1,836,448
Long-term liabilities:
Deferred revenue 23,782,978 --
------------- -------------
Total liabilities 25,882,556 1,836,448
Total stockholders' equity 35,630,439 49,198,543
------------- -------------
Total liabilities and stockholders'
equity $ 61,512,995 $ 51,034,991
============= =============
CONTACT: POZEN Inc.
Lisa Barthelemy, Director, Investor Relations
919-913-1044
John Barnhardt, Vice President, Finance and
Administration, 919-913-1030