Exhibit 99.1
Pozen Reports Third Quarter 2005 Results;
Trexima(TM) NDA Accepted for Filing by FDA in October
CHAPEL HILL, N.C.--(BUSINESS WIRE)--October 27, 2005--POZEN Inc.
(NASDAQ: POZN), today announced results for the third quarter ended
September 30, 2005.
Third-Quarter Results
POZEN reported a net loss of $4.7 million, or $0.16 per share on a
fully diluted basis, for the third quarter of 2005, compared to a net
loss of $5.8 million, or $0.20 per share on a fully diluted basis, for
the third quarter of 2004.
For the third quarter of 2005, POZEN reported revenue of $2.4
million as compared to $1.9 million for the third quarter of 2004.
Revenue for the quarters ended September 30, 2005 and September 30,
2004 resulted from the amortization of upfront payments received
pursuant to collaboration agreements for MT 100(TM), MT 300(TM) and
Trexima.
Operating expenses for the third quarter of 2005 totaled $7.4
million as compared to $7.9 million for the comparable period in 2004.
The decrease in operating expenses was primarily due to a decrease in
development costs associated with Trexima.
At September 30, 2005, cash, cash equivalents and short-term
investments totaled $31.3 million compared to $51.8 million at
December 31, 2004.
Nine-Month Results
POZEN reported a net loss of $14.2 million, or $0.49 per share on
a fully diluted basis, for the nine-month period ended September 30,
2005, compared with net income of $3.2 million, or $0.11 per share on
a fully diluted basis, for the same period in 2004.
For the nine months ended September 30, 2005, POZEN reported
revenue of $6.4 million compared to $20.7 million for the same period
in 2004. The higher revenue in 2004 was due to a $15 million milestone
payment from GlaxoSmithKline(GSK).
Operating expenses for the nine months ended September 30, 2005
were $21.4 million as compared to $18.0 million for the comparable
period in 2004. The increase in operating expenses was due primarily
to costs associated with the PPI/NSAID exploratory development
program, an increase in personnel related expenses for our research
and development activities and an increase in costs associated with
public company activities.
Corporate Highlights
The Trexima New Drug Application (NDA) was filed in August, 2005
and accepted by the FDA in October, 2005. POZEN received a $20 million
milestone payment from GSK in October.
Results of the 14-day proof-of-concept study with its drug
candidate PN 100 have been selected for platform presentation at the
Annual Scientific Meeting of the American College of Gastroenterology
in November. POZEN received a patent on the "Pharmaceutical
Composition for the Coordinated Delivery of NSAID" during August 2005.
The company's PN/PA product platform is covered under this patent.
Financial Guidance
For the fourth quarter of 2005, POZEN expects total revenues to be
approximately $22 million, and total operating expenses to be in the
range of $6.5 million to $8.5 million.
For the 2005 year, POZEN expects total revenue to be approximately
$28 million, which includes the $20 million milestone payment from
GSK. Total operating expenses for the 2005 year are expected to be in
the range of $28 million to $30 million.
Third-Quarter Results Webcast
POZEN will hold a webcast to present third quarter results and
management's outlook on Thursday, October 27, 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 a development and
commercialization alliance with GlaxoSmithKline. 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 period ended June 30, 2005 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 Nine Months Ended
September 30, September 30,
----------------------- ------------------------
2005 2004 2005 2004
----------------------- ------------------------
Revenue $ 2,399,000 $ 1,891,499 $ 6,410,374 $20,670,499
Operating expenses:
General and
administrative 2,473,439 2,065,869 7,198,656 6,071,475
Research and
development 4,900,642 5,859,319 14,231,894 11,903,282
----------- ----------- ------------ -----------
Total operating
expenses 7,374,081 7,925,188 21,430,550 17,974,757
Interest and other
income 289,303 202,369 846,507 463,342
----------- ----------- ------------ -----------
Net income (loss)
attributable to
common stockholders $(4,685,778)$(5,831,320)$(14,173,669)$ 3,159,084
=========== =========== ============ ===========
Basic net income
(loss) per common
share $ (0.16)$ (0.20)$ (0.49)$ 0.11
=========== =========== ============ ===========
Shares used in
computing basic net
income (loss) per
common share 28,929,503 28,779,277 28,919,245 28,713,806
=========== =========== ============ ===========
Diluted net income
(loss) per common
share $ (0.16) (0.20)$ (0.49) 0.11
=========== =========== ============ ===========
Shares used in
computing diluted
net income (loss)
per common share 28,929,503 28,779,277 28,919,245 29,666,989
=========== =========== ============ ===========
POZEN Inc.
Balance Sheet
(Unaudited)
September 30, December 31,
2005 2004
------------- ------------
ASSETS
Current assets:
Cash and cash equivalents $ 11,545,728 $ 51,764,129
Investments 19,778,456 -
Prepaid expenses and other current assets 74,773 1,064,032
------------- ------------
Total current assets 31,398,957 52,828,161
Equipment, net of accumulated depreciation 267,656 467,688
------------- ------------
Total assets $ 31,666,613 $ 53,295,849
============= ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 580,580 $ 2,330,349
Accrued compensation 2,432,372 1,182,848
Accrued expenses 1,119,001 1,626,829
Deferred revenue 8,789,000 8,680,092
------------- ------------
Total current liabilities 12,920,953 13,820,118
Long-term liabilities:
Deferred revenue 1,000,000 7,764,978
------------- ------------
Total liabilities 13,920,953 21,585,096
Total stockholders' equity 17,745,660 31,710,753
------------- ------------
Total liabilities and stockholders'
equity $ 31,666,613 $ 53,295,849
============= ============
CONTACT: POZEN Inc.
Bill Hodges, Chief Financial Officer, 919-913-1030
or
Fran Barsky, Director, Investor Relations, 919-913-1044