POZEN Inc. (NASDAQ: POZN), today announced results for the second
quarter ended June 30, 2008.
Second-Quarter Results
POZEN reported net income of $13.3 million, or $0.43 per share on
a diluted basis, for the second quarter of 2008, compared to a net
loss of ($3.8) million, or ($0.13) loss per share on a diluted basis,
for the second quarter of 2007.
For the second quarter of 2008, POZEN reported revenue of $33.1
million as compared to $11.9 million for the second quarter of 2007.
The increase in revenue was primarily due to the receipt of $20
million in milestone payments from GlaxoSmithKline (GSK).
Operating expenses for the second quarter of 2008 totaled $20.3
million as compared to $16.5 million for the comparable period in
2007. The increase in operating expenses was primarily due to an
increase in costs associated with the PN program.
At June 30, 2008, cash, cash equivalents and short-term
investments totaled $72.2 million compared to $73.9 million at
December 31, 2007. POZEN has a $9.4 million receivable balance due
from AstraZeneca and GSK at June 30, 2008.
Six-Month Results
POZEN reported net income of $6.0 million, or $0.19 per share on a
diluted basis, for the six-month period ended June 30, 2008, compared
with a net loss of ($5.9) million, or ($0.20) loss per share on a
diluted basis, for the same period in 2007.
For the six months ended June 30, 2008, POZEN reported revenue of
$41.0 million compared to $19.6 million for the same period in 2007.
The increase in revenue was primarily due to the receipt of $20
million in milestone payments from GSK.
Operating expenses for the six months ended June 30, 2008 were
$36.2 million as compared to $27.1 million for the comparable period
in 2007. The increase in operating expenses was primarily due to
increase in costs associated with the PN program.
Corporate Highlights
Treximet(TM) (sumatriptan and naproxen sodium) tablets were
launched by GlaxoSmithKline in mid-May for the acute treatment of
migraine, with or without aura, in adults. POZEN accrued $0.8 million
for royalties in the quarter based on estimated Treximet net sales.
Treximet has already overtaken the three smallest products in the
category and achieved 3.7% of new migraine prescriptions for the month
of June 2008, according to IMS.
A podium presentation on the PN 200 (immediate release omeprazole
20 mg, and enteric coated naproxen 500 mg) concept trial was presented
at Digestive Disease Week on May 18, 2008 by Dr. Jay Goldstein,
Professor of Medicine with the Department of Medicine, University of
Illinois at Chicago. The results demonstrated a clinically significant
benefit (p less than 0.001) for PN 200 versus enteric coated naproxen
through the six-month treatment period, and showed a cumulative
incidence of gastric ulcers (the primary endpoint) of 8.3% for PN 200
vs. 29.4% for 500 mg enteric coated naproxen.
POZEN filed a Special Protocol Assessment (SPA) for PA32540 in
June 2008. As part of the submission, POZEN provided data indicating
that PA32540 is bioequivalent to 325 mg enteric coated aspirin.
Financial Guidance
For the 2008 year, POZEN continues to expect total revenue to be
in the range of $62 to $68 million. Expected revenue includes the $20
million in milestone payments already received from GSK in April 2008.
Total operating expenses are expected to be in the range of $67 to $71
million, including $5 to $6 million of non-cash stock-based
compensation expense.
Second-Quarter Results Webcast
POZEN will hold a webcast to present second quarter results and
management’s outlook on Tuesday, July 29, 2008 at 10:00 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. 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 Treximet, which was recently
approved by the United States Food and Drug Administration for the
acute treatment of migraine attacks, with or without aura, in adults,
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, 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 Quarterly Report on Form 10-Q for the
period ended March 31, 2008. 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.
Statements of Operations
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
———————– ———————–
2008 2007 2008 2007
———- ———— ———- ————
Revenue:
Licensing
revenue $24,519,015 $ 3,701,000 $28,370,096 $ 7,402,000
Development
revenue 8,605,038 8,233,383 12,582,946 12,188,387
———- ———– ———- ———–
Total revenue 33,124,053 11,934,383 40,953,042 19,590,387
Operating expenses:
General and
administrative 3,142,869 2,924,565 5,991,842 6,155,104
Research and
development 17,144,221 13,603,599 30,256,753 20,908,017
———- ———– ———- ———–
Total operating
expenses 20,287,090 16,528,164 36,248,595 27,063,121
Other income:
Interest and
other income,
net 497,140 746,706 1,258,404 1,536,019
Net income (loss)
attributable to
common stockholders $13,334,103 $(3,847,075) $ 5,962,851 $(5,936,715)
========== =========== ========== ===========
Basic net income
(loss) per common
share $ 0. flonase. 45 $ (0.13) $ 0.20 $ (0.20)
========== =========== ========== ===========
Shares used in
computing basic net
income (loss) per
common share 29,759,250 29,502,372 29,741,406 29,485,882
========== =========== ========== ===========
Diluted net income
(loss) per common
share $ 0.43 (0.13) $ 0.19 (0.20)
========== =========== ========== ===========
Shares used in
computing diluted
net
income (loss) per
common share 30,707,710 29,502,372 30,636,529 29,485,882
========== =========== ========== =========== POZEN Inc.
Balance Sheets
(Unaudited)
June 30, December 31,
2008 2007
———- ————
ASSETS
Current assets:
Cash and cash equivalents $31,202,497 $ 37,660,068
Investments 41,025,121 36,282,108
Accounts Receivable 9,429,038 2,129,003
Prepaid expenses and other current assets 662,020 1,198,397
———- ————
Total current assets 82,318,676 77,269,576
Equipment, net of accumulated depreciation 84,668 117,485
———- ————
Total assets $82,403,344 $ 77,387,061
========== ============
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 5,387,048 $ 2,536,040
Accrued compensation 983,855 1,392,849
Accrued expenses 5,132,885 3,796,164
Deferred revenue 15,780,058 15,936,125
———- ————
Total current liabilities 27,283,846 23,661,178
Long-term liabilities:
Deferred revenue 11,085,044 18,475,074
———- ————
Total liabilities 38,368,890 42,136,252
Total stockholders’ equity 44,034,454 35,250,809
———- ————
Total liabilities and stockholders’
equity $82,403,344 $ 77,387,061
========== ============
*T