CHAPEL HILL, N.C.--(BUSINESS WIRE)--May 2, 2007--POZEN Inc.
(NASDAQ: POZN), today announced results for the first quarter ended
March 31, 2007.
POZEN reported a net loss of $2.1 million, or $0.07 per share on a
diluted basis, for the first quarter of 2007, compared to a net loss
of $6.4 million, or $0.22 per share on a diluted basis, for the first
quarter of 2006.
For the first quarter of 2007, POZEN reported revenue of $7.7
million resulting from the amortization of upfront payments received
pursuant to collaboration agreements with AstraZeneca and
GlaxoSmithKline and revenue from development work performed under
those agreements. Revenue for the first quarter ended March 31, 2006
totaled $2.2 million.
Operating expenses for the first quarter of 2007 totaled $10.5
million as compared to $9.1 million for the comparable period in 2006.
The increase in operating expenses was primarily due to an increase in
costs associated with the PN and PA programs, partially offset by a
decrease in cost for the lornoxicam program.
At March 31, 2007, cash, cash equivalents and short-term
investments totaled $58.2 million compared to $62.6 million at
December 31, 2006.
Results from two pivotal efficacy studies for Trexima(TM)
(sumatriptan/naproxen sodium) were published in the Journal of the
American Medical Association (JAMA) in April 2007. The studies
demonstrated that Trexima provided superior headache relief at two
hours and four hours compared to placebo, and sustained pain-free
results from two through 24-hours after dosing versus sumatriptan or
Abstracts on Trexima are being presented today at the 59th Annual
Meeting of the American Academy of Neurology in Boston.
The Trexima amended response to the U.S. Food and Drug
Administration (FDA) approvable letter was accepted for review by the
FDA. The FDA notified POZEN that it considers the response a class 2
review (six months); therefore, the FDA action date is August 1, 2007.
For the second quarter of 2007, POZEN expects total revenue to be
in the range of $11.7 to $14.7 million, including $3.7 million from
the amortization of upfront payments from AstraZeneca and
GlaxoSmithKline and revenue of $8 to $11 million for work performed
under the AstraZeneca agreement. Total operating expenses are expected
to be in the range of $15 to $18 million, including $1.5 million of
non-cash stock-based compensation expense.
POZEN and AstraZeneca are currently in discussions on the timing
and scope of marketing studies to support the commercialization of PN
400. AstraZeneca will pay POZEN to conduct these studies. These
marketing studies may impact revenue and expenses for the 2007 year.
We expect to have more definitive information at the end of the second
quarter at which time we will provide updated guidance.
First-Quarter Results Webcast
POZEN will hold a webcast to present first quarter 2007 results
and management's outlook on Wednesday, May 2, 2007 at 11:00 a.m.
Eastern time. The webcast can be accessed live and will be available
for replay at www.pozen.com.
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. POZEN's
efforts are focused primarily on the development of pharmaceutical
products for the treatment of acute and chronic pain and other
pain-related conditions. POZEN has development and commercialization
alliances with GlaxoSmithKline for the proposed product candidate
Trexima(TM) combining sumatriptan, formulated with RT Technology(TM),
and naproxen sodium in a single tablet for the acute treatment of
migraine, which is currently under review by the United States Food
and Drug Administration, and with AstraZeneca for proprietary fixed
dose combinations of naproxen with the proton pump inhibitor
esomeprazole magnesium in a single tablet for conditions such as
osteoarthritis and rheumatoid arthritis in patients who are at risk
for developing NSAID-associated gastric ulcers. 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 Annual Report on
Form 10-K for the period ended December 31, 2006. We do not intend to
update any of these factors or to publicly announce the results of any
revisions to these forward-looking statements.
Statements of Operations
Three Months Ended
Licensing revenue $ 7,656,004 $ 2,237,000
General and administrative 3,230,539 3,652,470
Research and development 7,304,418 5,488,178
Total operating expenses 10,534,957 9,140,648
Interest and other income 789,313 458,857
Net loss attributable to common stockholders $(2,089,640) $(6,444,791)
Basic and diluted net loss per common share $ (0.07) $ (0.22)
Shares used in computing basic and diluted
net loss per common share 29,469,392 29,114,570
March 31, December 31,
Cash and cash equivalents $31,233,022 $26,296,884
Investments 26,950,846 36,285,102
Accounts Receivable 3,955,004 3,267,153
Prepaid expenses and other current
assets 715,652 1,108,506
Total current assets 62,854,524 66,957,645
Equipment, net of accumulated depreciation 170,213 183,468
Total assets $63,024,737 $67,141,113
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $1,345,426 $965,563
Accrued compensation 523,754 1,434,591
Accrued expenses 2,375,649 1,756,300
Deferred revenue 14,169,200 14,870,200
Total current liabilities 18,414,029 19,026,654
Deferred revenue 21,000,000 24,000,000
Total liabilities 39,414,029 43,026,654
Total stockholders' equity 23,610,708 24,114,459
Total liabilities and stockholders'
equity $63,024,737 $67,141,113
CONTACT: POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
Fran Barsky, 919-913-1044
Director, Investor Relations
SOURCE: POZEN Inc.