Q1 Released ! Better than we thought!
CHAPEL HILL, N.C., Apr 29, 2010 (BUSINESS WIRE) -- POZEN Inc. (NASDAQ: POZN),
today announced results for the first quarter ended March 31, 2010.
First Quarter Results
POZEN reported a net loss of $(3.0) million, or $(0.10) per share on a diluted
basis, for the first quarter of 2010, compared to a net loss of $(3.5) million,
or $(0.12) per share on a diluted basis, for the first quarter of 2009.
For the first quarter of 2010, POZEN reported revenue of $6.9 million resulting
from royalty on sales of Treximet(R) (sumatriptan / naproxen sodium) of $3.8
million and the amortization of upfront payments received pursuant to the
collaboration agreement with AstraZeneca of $3.1 million. Revenue for the first
quarter ended March 31, 2009 totaled $8.8 million, resulting from royalty on
sales of Treximet of $1.0 million, $4.7 million of revenue for development work
performed under our collaboration agreement and the amortization of upfront
payments of $3.1 million.
Operating expenses for the first quarter of 2010 totaled $9.9 million as
compared to $12.5 million for the comparable period in 2009. The decrease in
operating expenses was primarily due to a decrease in costs associated with the
development program for VIMOVO(TM) (naproxen / esomeprazole magnesium),
partially offset by increases in the PA32540 development program and patent
litigation expenses.
At March 31, 2010, cash, cash equivalents and short-term investments totaled
$36.7 million compared to $46.7 million at December 31, 2009. The Company has an
accounts receivable balance of $3.8 million from GlaxoSmithKline at March 31,
2010.
Corporate Highlights
Treximet(R)
Net sales of Treximet(R) totaled $21.0 million for GlaxoSmithKline in the first
quarter of 2010, generating royalty revenue of $3.8 million for POZEN. Total
prescriptions increased approximately 7.9% according to IMS Health data in the
first quarter, compared to the first quarter of 2009.*
* Note: This information is an estimate derived from the use of information
under license from the following IMS Health information service: NPA(TM) Plus
for the period January 2009 -- March 2010. IMS expressly reserves all rights,
including rights of copying, distribution and republication.
VIMOVO(TM), formerly PN 400
The NDA for VIMOVO(TM) was submitted on June 30, 2009 and is under review by the
U.S. Food and Drug Administration (FDA). We expect a response from the FDA on or
about April 30, 2010. Pursuant to the collaboration agreement with AstraZeneca,
POZEN will earn a $20 million milestone payment from AstraZeneca upon FDA
approval of VIMOVO. Results from the pivotal trials for VIMOVO were presented at
the American College of Rheumatology Scientific Session in Philadelphia in
October 2009. AstraZeneca submitted a Marketing Authorization Application (MAA)
to the European Union via the Decentralized Procedure for VIMOVO in October
2009.
PA Program
POZEN is creating a safer form of aspirin family of product candidates -- the PA
product platform. The first candidate, PA32540, is a coordinated-delivery tablet
combining immediate-release omeprazole, a PPI, layered around pH-sensitive
aspirin. It utilizes the same multi-layer, sequential delivery technology as
VIMOVO in that the gastro-protective agent, omeprazole, is deployed prior to the
dissolution of the gastric-offending agent, aspirin. This novel, patented
product is administered orally once a day and is under investigation for use for
the secondary prevention of cardiovascular disease. The Company initiated the
two Phase 3 pivotal trials for PA32540 in October 2009, in addition to a one
year long safety study. The primary endpoint for the pivotal trials is the
cumulative incidence of gastric ulcers over the six-month treatment period for
PA32540 versus 325 mg of enteric-coated aspirin.
An estimated 80 million U.S. adults have some form of cardiovascular disease,
and the disease remains the #1 cause of death for men and women alike. PA32540
is being developed to deliver the cardio-protective benefits of aspirin while
reducing the GI toxicity. If approved, it will offer a new therapeutic option to
patients with cardiovascular disease and to doctors who treat them.
The POZEN PA pipeline also includes earlier-stage work evaluating the
application of aspirin combinations for pain and pain-related conditions. POZEN
is advancing commercialization plans for the PA franchise within the U.S. For
markets outside the U.S., the company plans to seek strong global commercial
partners.
Financial Guidance
POZEN will earn a $20 million milestone payment upon the U.S. Food and Drug
Administration (FDA) approval of VIMOVO and will start to earn royalty revenue
when AstraZeneca begins commercial sales. We plan to provide financial guidance
for the 2010 fiscal year when we can determine the timing of these important
events.
First Quarter Results Webcast
POZEN will host a webcast to present first quarter 2010 results and management's
outlook on Thursday, April 29, 2010 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 Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company
committed to transforming medicine that transforms lives. Since its founding in
1996, POZEN has successfully created novel pharmacologic agents primarily for
pain and pain-related conditions by combining existing drug therapies that
result in superior patient outcomes. Moving forward, POZEN is poised to become a
model 21st century pharmaceutical company dedicated to ensuring that they
produce cost-effective, evidence-based medicines; take a fresh approach to
sales, marketing and medical education; and deliver high-quality, affordable
pharmaceuticals to their customers. The Company's common stock is traded on The
NASDAQ Stock Market under the symbol "POZN". For more detailed company
information, including copies of this and other press releases, please visit:
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 VIMOVO), 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, including our dependence on
GlaxoSmithKline for the sales and marketing of Treximet; 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, 2009. We do not
intend to update any of these factors or to publicly announce the results of any
revisions to these forward-looking statements.
P
OZEN Inc.
Statements of Operations
(Unaudited)
Three Months Ended
March 31,
--------------------------
2010 2009
----------- -----------
Revenue:
Licensing revenue $ 6,857,302 $ 4,103,620
Development revenue 68,077 4,654,762
----------- -----------
Total revenue 6,925,379 8,758,382
Operating expenses:
General and administrative 5,206,669 4,427,992
Research and development 4,718,231 8,025,356
----------- -----------
Total operating expenses 9,924,900 12,453,348
Other Income:
Interest and other income, net 32,895 231,707
----------- -----------
Loss before income tax benefit (2,966,626) (3,463,259)
Income tax benefit - -
----------- -----------
Net loss attributable to common stockholders $ (2,966,626) $ (3,463,259)
=========== ===========
Basic net loss per common share $ (0.10) $ (0.12)
=========== ===========
Shares used in computing basic net loss per common share 29,833,553 29,778,310
=========== ===========
Diluted net loss per common share $ (0.10) $ (0.12)
=========== ===========
Shares used in computing diluted net loss per common share 29,833,553 29,778,310
=========== ===========
P
OZEN Inc.
Balance Sheets
(Unaudited)
March 31, December 31,
2010 2009
---------- ------------
ASSETS
Current assets:
Cash and cash equivalents $ 23,139,839 $ 23,278,353
Short-term investments 13,560,397 23,432,100
Accounts receivable 3,848,680 1,146,072
Prepaid expenses and other current assets 1,070,700 1,259,255
---------- ------------
Total current assets 41,619,616 49,115,780
Equipment, net of accumulated depreciation 51,972 43,830
---------- ------------
Total assets $ 41,671,588 $ 49,159,610
========== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,988,229 $ 2,412,335
Accrued compensation 535,650 2,287,200
Accrued expenses 3,288,014 3,501,262
Deferred revenue 4,114,903 7,201,080
---------- ------------
Total current liabilities 9,926,796 15,401,877
Long-term liabilities:
Deferred revenue - -
---------- ------------
Total liabilities 9,926,796 15,401,877
Total stockholders' equity 31,744,792 33,757,733
---------- ------------
Total liabilities and stockholders' equity $ 41,671,588 $ 49,159,610
========== ============
SOURCE: POZEN Inc.
CONTACT:
POZEN Inc.
Bill Hodges, Chief Financial Officer
919-913-1030
Copyright Business Wire 2010
-0-
KEYWORD: United States
North America
North Carolina
INDUSTRY KEYWORD: Health
Pharmaceutical
SUBJECT CODE: Advisory
Earnings
Conference Call
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