CHAPEL HILL, N.C.--(BUSINESS WIRE)--April 27, 2006--POZEN Inc.
(NASDAQ: POZN), today announced results for the first quarter ended
March 31, 2006.
POZEN reported a net loss of $6.4 million, or $0.22 per share on a
diluted basis, for the first quarter of 2006, compared to a net loss
of $5.4 million, or $0.19 per share on a diluted basis, for the first
quarter of 2005.
For the first quarter of 2006, POZEN reported revenue of $2.2
million resulting from the amortization of upfront payments received
pursuant to collaboration agreements for MT 300(TM) and Trexima(TM).
Revenue for the first quarter ended March 31, 2005 was $2.1 million.
Operating expenses for the first quarter of 2006 totaled $9.1
million as compared to $7.7 million for the comparable period in 2005.
The increase in operating expenses was primarily due to a $1.9 million
charge for non-cash stock-based compensation expenses, related to
stock options and other stock-based awards, associated with the
adoption of Statement of Financial Accounting Standard No. 123(R) on
January 1, 2006. Of this amount, $1.2 million was charged to general
and administrative expense and $0.7 million was charged to research
and development expense.
At March 31, 2006, cash, cash equivalents and short-term
investments totaled $39.6 million compared to $45.8 million at
December 31, 2005.
New data from the Trexima Phase III pivotal trials was presented
at the American Academy of Neurology scientific meeting in San Diego
on April 4-5, 2006. The data presented included poster presentations
on satisfaction, productivity and long-term safety, and a podium
presentation on the superior clinical benefits of Trexima.
POZEN reached agreement with the U.S. Food and Drug Administration
(FDA) on a Special Protocol Assessment (SPA) for the pivotal Phase III
clinical trial for its product candidate PN 200, the combination of
omeprazole and naproxen, for the treatment of the signs and symptoms
of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in
patients at risk for developing NSAID-associated gastric ulcers.
POZEN announced the appointment of Donald H. Namm and James J.
Mauzey to its Board of Directors in March 2006. Ted G. Wood and James
R. Butler have elected to resign from the Board of Directors effective
May 16, 2006, the date of the annual meeting of shareholders.
For the second quarter of 2006, POZEN expects total revenues to be
approximately $2.2 million, and total operating expenses to be in the
range of $9.2 million to $11.2 million. The amount of operating
expenses reflects estimated non-cash stock-based compensation expenses
of approximately $1.7 million, associated with the adoption of
Statement of Financial Accounting Standard No. 123(R) on January 1,
For the 2006 year, POZEN expects total revenue to be in the range
of $26 million to $30 million, which includes two anticipated $10
million milestone payments from GSK in connection with the Trexima
collaboration. Total operating expenses for the 2006 year are expected
to be in the range of $39 million to $43 million and will vary
depending upon the timing and pace of our development programs,
particularly the PPI/NSAID Phase III programs. The expected total
operating expenses reflects estimated non-cash stock-based
compensation expenses in the range of $7.0 million to $7.2 million,
associated with the adoption of Statement of Financial Accounting
Standard No. 123(R) on January 1, 2006.
First-Quarter Results Webcast
POZEN will hold a webcast to present first quarter 2006 results
and management's outlook on Thursday, April 27, 2006 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. Since its
inception, POZEN has focused its efforts primarily on the development
of pharmaceutical products for the treatment of acute and chronic
pain, migraine, and other pain-related conditions. 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 Annual Report on
Form 10-K for the period ended December 31, 2005. 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...
Statement of Operations
Three Months Ended
Licensing revenue $ 2,237,000 $ 2,052,490
General and administrative 3,652,470 2,396,586
Research and development 5,488,178 5,327,785
Total operating expenses 9,140,648 7,724,371
Interest and other income 458,857 271,673
Net loss attributable to common
Basic and diluted net loss per common
share $ (0.22)$ (0.19)
Shares used in computing basic and
diluted net loss per common share 29,114,570 28,912,721
March 31, Dec. 31,
Cash and cash equivalents $15,161,995 $27,467,789
Investments 24,409,925 18,370,701
Prepaid expenses and other current assets 551,923 613,682
Total current assets 40,123,843 46,452,172
Equipment, net of accumulated depreciation 222,970 234,839
Total assets $40,346,813 $46,687,011
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $ 1,437,087 $ 1,443,676
Accrued compensation 369,657 2,591,633
Accrued expenses 1,662,026 1,201,023
Deferred revenue 4,315,000 6,552,000
Total current liabilities 7,783,770 11,788,332
Deferred revenue 1,000,000 1,000,000
Total liabilities 8,783,770 12,788,332
Total stockholders' equity 31,563,043 33,898,679
Total liabilities and stockholders' equity $40,346,813 $46,687,011
CONTACT: POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
Fran Barsky, 919-913-1044
Director, Investor Relations
SOURCE: POZEN Inc.