EXHIBIT 99.1
POZEN Reports Fourth Quarter and Year End 2004 Results;
Completes First Trexima Phase III Study
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Feb. 28, 2005--POZEN Inc. (NASDAQ:
POZN), today announced results for the fourth quarter and twelve months ended
December 31, 2004.
Fourth-Quarter Results
POZEN reported a net loss of $8.4 million, or $0.29 per share on a fully
diluted basis, for the fourth quarter of 2004, compared to a net loss of $1.6
million, or $0.06 per share on a fully diluted basis, for the fourth quarter of
2003.
Revenue for the quarters ended December 31, 2004 and December 31, 2003
totaled $2.4 and $1.8 million, respectively. Revenue resulted from the
amortization of upfront payments received in 2003 pursuant to collaboration
agreements for MT 100(TM), MT 300(TM), and Trexima(TM), and revenue earned for
conducting additional FDA required Trexima Phase I studies.
Total operating expenses for the quarter ended December 31, 2004 were $11.1
million as compared to $3.6 million for the same period in 2003. The increase in
operating expenses was due to product development, primarily Trexima Phase III
clinical costs, and general and administrative costs, primarily legal fees,
Sarbanes-Oxley auditing and marketing research.
At December 31, 2004, cash and cash equivalents totaled $51.8 million
compared to $60.5 million at December 31, 2003.
Twelve-Month Results
POZEN reported a net loss of $5.3 million, or $0.18 per share on a fully
diluted basis, for the twelve-month period ended December 31, 2004, compared to
a net loss of $14.9 million, or $0.52 per share on a fully diluted basis, for
the same period of 2003.
For the twelve months ended December 31, 2004, POZEN reported revenue of
$23.1 million as compared to $3.7 million for the same period of 2003. Revenue
for the period ended December 31, 2004 resulted from the amortization of
payments received under collaboration agreements for MT 100, MT 300, and
Trexima, the receipt of a $15.0 million milestone payment from GlaxoSmithKline
(GSK) for commencement of Phase III clinical trial activities for Trexima and
revenue earned for conducting additional FDA required Trexima Phase I studies.
Total operating expenses for the twelve months ended December 31, 2004 were
$29.1 million as compared to $19.1 million for the same period in 2003. The
increase in operating expenses was due to higher product development costs,
primarily Trexima Phase III costs.
Corporate Highlights
POZEN completed the first of two Phase III pivotal trials for Trexima for
the treatment of migraine headaches. Trexima is GSK's proposed brand name for
the combination of sumatriptan formulated with RT Technology(TM) and naproxen
sodium in a single tablet. GSK and POZEN are collaborating on the development of
Trexima.
Trexima demonstrated superiority over the individual components measured by
sustained pain-free response (p less than .001) and, with the exception of the
incidence of nausea-free at two hours, all other regulatory endpoints were met
(p less than .001). Trexima did reach statistical significance for the nausea
endpoint compared to placebo after two hours and maintained superiority through
twenty-four hours. All of the active treatments (Trexima, sumatriptan and
naproxen) had a similar incidence of nausea at two hours compared to placebo.
Submission of the new drug application (NDA) with the U.S. Food and Drug
Administration is planned for the second half of 2005.
POZEN has received a letter from the advisory group (Committee on Safety of
Medicines (CSM)) to the Medicines and Healthcare Products Regulatory Agency
(MHRA) in the United Kingdom agreeing to advise the MHRA that a marketing
authorization be granted for MT 100 in the U.K., provided that POZEN supplies
additional information and meets certain conditions specified in the letter.
POZEN has sent the required information to the U.K.
POZEN is scheduled to present MT 100 to an FDA Advisory Committee for
consideration, with particular emphasis on the potential risk of tardive
dyskinesia. A tentative date in May 2005 has been proposed.
POZEN has been issued a European patent covering its MT 400(TM) technology
for proprietary combinations of a triptan (5-HT agonist) and a non-steroidal
anti-inflammatory drug (NSAID) for use in the acute treatment of migraine. The
European patent designates 18 countries in Europe.
POZEN's board of directors approved the adoption of a stockholder rights
plan, which is similar to plans adopted by many other public companies. The plan
was adopted by the board of directors on January 12, 2005.
Financial Guidance
For the first quarter of 2005, POZEN expects total revenues to be
approximately $2.1 million, and total operating expenses to be in the range of
$6 million to $8 million.
For the 2005 year, POZEN expects total revenue to be approximately $28
million, and total operating expenses to be in the range of $28 million to $32
million. These estimates of revenue and expenses reflect the expected completion
of Trexima Phase III clinical trials and the submission of the resulting NDA.
Fourth-Quarter Results Webcast
POZEN will hold a webcast to present fourth quarter results and
management's outlook on Monday, February 28, 2005 at 11:00 a.m. Eastern time.
The webcast can be accessed live and will be available for replay 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
focused its efforts primarily on the development of pharmaceutical products for
the treatment of migraine. POZEN is also exploring the development of product
candidates in other pain-related therapeutic areas. 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 of our
product candidates, including as a result of the need to conduct additional
studies, or the failure to obtain such approval of our product candidates;,
including as a result of changes in regulatory standards or the regulatory
environment during the development period of any 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, 2004 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 Twelve Months Ended
December 31, December 31,
----------------------- ------------------------
2004 2003 2004 2003
----------------------- ------------------------
Revenue:
Licensing revenue $ 2,417,409 $ 1,830,002 $23,087,908 $ 3,717,000
Operating expenses:
General and
administrative 2,589,357 1,899,280 8,660,832 9,211,341
Research and
development 8,495,466 1,689,124 20,398,748 9,904,347
----------- ----------- ----------- ------------
Total operating
expenses 11,084,823 3,588,404 29,059,580 19,115,688
Interest income, net 247,858 140,500 711,200 535,370
----------- ----------- ----------- ------------
Net income (loss)
attributable to
common stockholders (8,419,556)$(1,617,902)$(5,260,472)$(14,863,318)
=========== =========== =========== ============
Basic net income
(loss) per common
share $ (0.29)$ (0.06)$ (0.18)$ (0.52)
=========== =========== =========== ============
Shares used in
computing basic net
income (loss) per
common share 28,852,743 28,489,043 28,748,540 28,329,339
=========== =========== =========== ============
POZEN Inc.
Balance Sheet
(Unaudited)
Dec. 31, Dec. 31,
2004 2003
----------- -----------
ASSETS
Current assets:
Cash and cash equivalents $51,764,129 $60,480,690
Prepaid expenses and other current assets 1,064,032 698,209
----------- -----------
Total current assets 52,828,161 61,178,899
Equipment, net of accumulated depreciation 467,688 334,096
----------- -----------
Total assets $53,295,849 $61,512,995
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,330,349 $ 579,903
Accrued compensation 1,182,848 416,053
Accrued expenses 1,626,829 1,103,622
Deferred revenue 8,680,092 7,562,000
----------- -----------
Total current liabilities 13,820,118 9,661,578
Long-term liabilities:
Deferred revenue 7,764,978 16,220,978
----------- -----------
Total liabilities 21,585,096 25,882,556
Total stockholders' equity 31,710,753 35,630,439
----------- -----------
Total liabilities and stockholders'
equity $53,295,849 $61,512,995
=========== ===========
CONTACT: POZEN Inc.
Chief Financial Officer
Bill Hodges, 919-913-1030
or
Director, Investor Relations
Fran Barsky, 919-913-1044