CHAPEL HILL, N.C., Nov. 8 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company whose lead product candidate for the
treatment of migraine is in late Phase III clinical trials, today announced
results for the first time as a public company. The financial performance met
management's expectations for the third quarter and nine months ended
September 30, 2000. After the quarter closed, POZEN completed its initial
public offering, selling 5.75 million shares including the overallotment
option.
Third-Quarter Results
POZEN is a development-stage company that has not recorded revenues. For
the third quarter, the company had operating expenses excluding non-cash
amortization of deferred compensation of $7.9 million compared with
$3.0 million for the 1999 third quarter. Non-cash deferred compensation in
connection with employee stock option grants was $869,000 and $198,000 for the
2000 and 1999 periods, respectively.
POZEN's net loss attributable to common stockholders was $7.7 million,
excluding non-cash deferred compensation, a charge related to preferred stock
sold in August 2000, and dividends on preferred stock, versus $3.4 million for
the comparable 1999 period. The charge related to the sale of preferred stock
was a non-cash charge of $10.7 million that recognized the difference between
the deemed fair market value of the preferred stock and the fair market value
of the common stock. The preferred stock dividends totaled $439,000.
Excluding these items, POZEN's net loss per share would have been $0.28 when
the $7.7 million is divided by the 27.4 million shares outstanding after
giving effect to the IPO and the exercise of the overallotment option.
POZEN's basic and diluted net loss per common share and pro forma net loss per
common share are set forth in the following schedule.
Nine-Month Results
Operating expenses, excluding non-cash deferred compensation, were
$16.0 million compared with $6.7 million for the 1999 period. Non-cash
deferred compensation in connection with employee stock option grants was
$2.2 million and $431,000 for the 2000 and 1999 periods, respectively.
POZEN's net loss attributable to common stockholders was $15.4 million,
excluding non-cash deferred compensation, a charge related to preferred stock
sold in August 2000 and March 2000, and dividends on preferred stock, versus
$7.1 million for the comparable 1999 period. The charge related to the
preferred stock sales was a non-cash charge of $27.6 million that recognized
the difference between the deemed fair market value of the preferred stock and
the fair market value of the common stock. The dividends on preferred stock
totaled $830,000. Excluding these items, POZEN's net loss per share would
have been $0.56 when the $15.4 million is divided by the 27.4 million shares
outstanding after giving effect to the IPO and the exercise of the
overallotment option.
John R. Plachetka, Pharm.D., POZEN's president and chief executive
officer, noted that the company's performance was in line with management's
expectations. "The increase in operating expenses was largely due to higher
levels of development activity. For the full year ending December 31, 2000,
we anticipate that our operating expenses, excluding non-cash deferred
compensation, will be between $21 million and $23 million."
Strong, Liquid Balance Sheet
According to the company, if the sale of 5.75 million shares in the IPO
had been completed by September 30, 2000, POZEN would have had $97.7 million
in cash on hand. The company has no debt. "We believe we have sufficient
cash to fund the development of our current product portfolio," Plachetka
commented.
Late-Stage Product Pipeline
POZEN's initial focus is on developing products for migraine therapy, a
market estimated to exceed $2.0 billion by 2001. The company currently has
four products in development. Its lead product candidate, MT 100, which is in
late Phase III clinical trials, is an oral, first-line treatment. Data from
clinical trials to date indicate that MT 100 provides rapid and sustained
migraine relief with minimal side effects. MT 300, which is being developed
for relief of severe migraines, is in Phase III testing. MT 400, which is
designed to provide faster relief and a reduced relapse rate for migraine
sufferers, and MT 500, a product candidate for the prophylactic treatment of
migraine, are in initial clinical trials.
"We are proceeding according to schedule with the Phase III trials for MT
100," Plachetka said. "We expect these trials to be completed in the clinic
by the end of this year. Our next step will be to file a New Drug Application
(NDA) with the Food and Drug Administration (FDA) by the end of 2001.
Recently, the FDA approved our Investigational New Drug (IND) for a Phase II
clinical trial of MT 400, which we will commence shortly." Additionally, he
noted that the company has targeted filing an NDA for MT 300 early in 2002.
Plachetka also discussed POZEN's plans to secure marketing partners to
commercialize its products. "Now that we have completed our IPO, we have
turned our attention to partnership discussions. Our goal is to have a
marketing partner for our lead product candidate, MT 100, by the end of 2001."
POZEN's longer-term goal is to use its license-back model to acquire and
develop additional therapeutic products with commercial potential. Plachetka
pointed out that members of management have significant experience developing
drugs for diseases of the gastrointestinal and respiratory tracts, oncology
and infectious diseases.
Third-Quarter Conference Call
POZEN will hold a conference call to discuss third-quarter results and
management's outlook for the fourth quarter and next year at 11:00 a.m. EST on
Wednesday, November 8, 2000. The call can be accessed live and will be
available for replay over the Internet via www.vcall.com and
www.streetevents.com. A replay will be available on the company's website,
www.pozen.com.
North Carolina-based POZEN Inc. is a pharmaceutical development company
committed to building a portfolio of products with significant commercial
potential in select therapeutic areas. The company's initial focus is
migraine, where it has built a robust portfolio of four product candidates
through a combination of innovation and in-licensing. The company's common
stock is traded on The Nasdaq Stock Market under the symbol "POZN."
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 MT
100 and our other products; unanticipated costs and delays in the development
of MT 100 and our other products; our inability to enter into or maintain, and
the risks resulting from our dependence upon, collaboration or contractual
arrangements necessary for the development, manufacture, commercialization,
marketing, sales and distribution of our 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
our 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 Registration Statement filed on Form S-1 (File No. 333-35930) under
"Business" or " Risk Factors." We do not intend to update any of these
factors or to publicly announce the results of any revisions to these forward-
looking statements.
POZEN is on the Internet at www.pozen.com
POZEN Inc.
Statements of Operations
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
Operating expenses:
General and
administrative $1,238,735 $681,284 $3,288,752 $1,442,933
Research and
development 7,550,640 2,527,138 14,847,661 5,674,693
Total operating
expenses 8,789,375 3,208,422 18,136,413 7,117,626
Interest income
(expense), net 235,237 (401,281) 540,049 (443,289)
Net loss (8,554,138) (3,609,703) (17,596,364) (7,560,915)
Deemed dividend to
preferred
stockholders 10,741,990 -- 27,617,105 --
Preferred stock
dividends 439,307 -- 829,882 --
Net loss
attributable to
common
stockholders $(19,735,435) $(3,609,703) $(46,043,351) $(7,560,915)
Basic and diluted
net loss per
common share $(3.35) $(0.62) $(7.87) $(1.29)
Shares used in
computing basic
and diluted net
loss per
common share 5,887,246 5,844,167 5,850,520 5,844,167
Pro forma net loss
per common
shares-basic
and diluted $(1.00) $(0.31) $(2.59) $(0.68)
Pro forma weighted
average
common shares
outstanding-basic
and diluted 19,737,305 11,552,118 17,790,301 11,171,796
CONTACT:
Matt Czajkowski
Chief Financial Officer, of POZEN
+1-919-913-1040
or
General Inquiries
Kathy Brunson of FRB Weber Shandwick
+1-312-640-6696
