CHAPEL HILL, N.C., April 30 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, today announced results for the first quarter ended
March 31, 2001. The financial performance met management's expectations.
POZEN is a development-stage company that did not record revenues for the
first quarter of 2001 or during 2000.
For the first quarter of 2001, the company had operating expenses of
$5.0 million compared with $2.7 million for the 2000 first quarter, excluding
the non-cash amortization of deferred compensation. The non-cash amortization
of deferred compensation in connection with employee stock options grants was
$802,000 and $657,000 for the 2001 and 2000 periods, respectively.
POZEN's net loss attributable to common stockholders was $4.5 million, or
$0.16 per common share, for the quarter ended March 31, 2001 compared with
$3.3 million, or $0.56 per common share, for the 2000 quarter, excluding a
charge related to preferred stock sold in March 2000. The charge related to
the preferred stock sales was a non-cash charge of $16.9 million that
recognized the difference between the deemed fair value of the preferred stock
and the fair value of the common stock.
On a pro forma basis that assumes the conversion of all outstanding stock
into common stock as of the date of the original issuance, the loss for the
first quarter of 2000 would have been $1.36 per common share. Excluding the
charge related to preferred stock sold in March 2000, POZEN's pro forma net
loss per share would have been $0.22 for the quarter ended March 31, 2000.
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.
John R. Plachetka, Pharm.D., POZEN's chairman, president and chief
executive officer, noted that the company's performance was in line with
management's expectations. "As we anticipated, our quarter-over-quarter
operating expenses were higher due to increased clinical trial activities. We
expected that our operating expenses, excluding the non-cash amortization of
deferred compensation, would run between $4.5 million and $5.5 million for the
quarter, and they fell within that range."
POZEN's initial focus is on developing products for migraine therapy, a
global market expected to exceed $2.0 billion this year. The company has four
products in development. Its lead product candidate, MT 100, is intended to
be a first-line, oral treatment. MT 300 is being developed for relief of
severe migraine. MT 400 is designed to provide fast and longer-lasting relief
for migraine sufferers, while MT 500 is a product candidate for the
prophylactic treatment of migraine.
MT 100 has completed all planned Phase III pivotal clinical trials. MT
300 is expected to enter Phase III clinical testing in the third quarter of
2001. MT 400 has completed one Phase II clinical study and MT 500 is in
initial clinical trials.
"We continue to be pleased by the clinical performance of MT 100," Dr.
Plachetka said. "Because we see a substantial market opportunity with MT 100,
we intend to commence at least one additional study that has the potential to
expand labeling regarding MT 100's efficacy relative to other approved
Dr. Plachetka also announced that the FDA has agreed to accept, and POZEN
has just initiated, a six-month P53 transgenic mouse carcinogenicity study
with MT 100 in lieu of the standard two-year mouse study. Dr. Plachetka added
that the company is continuing discussions with the FDA regarding additional
carcinogenicity testing requirements.
With respect to MT 400, Dr. Plachetka stated that the data analyses from
the 900-patient Phase II study should be completed soon. However, the initial
evaluation indicates that the substantial advantage seen with MT 400 over
triptan therapy in a pilot study has been confirmed with a high degree of
Dr. Plachetka confirmed that discussions continue with parties interested
in commercializing MT 100 and MT 300 with the goal of finalizing a deal during
2001. Dr. Plachetka also noted that POZEN is continuing to evaluate new
product opportunities in other therapeutic areas using its "license back"
model and continuing to explore the feasibility of new, self-invented
Dr. Plachetka stated that POZEN believes it has sufficient cash to fund
the development of its current product portfolio. "At March 31, 2001 we had
$87.7 million in cash and equivalents. For the second quarter, we expect our
cash operating expenses will be in the range of $4.5 to $5.5 million. We
continue to expect that our cash operating expenses during 2001 will exceed
$25 million for the year."
First-Quarter Conference Call
POZEN will hold a conference call to discuss first-quarter results and
management's outlook for the year at 11:00 a.m. EDT on Monday, April 30, 2001.
The call can be accessed live and will be available for replay over the
Internet via www.streetevents.com . A replay will also 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; 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 Annual Report
on Form 10-K/A under "Management's Discussion and Analysis of Financial
Condition and Results of Operations." We do not intend to update any of these
factors or to publicly announce the results of any revisions to these forward-
POZEN is on the Internet at www.pozen.com
Statements of Operations
Three Months Ended
General and administrative $1,502,518 $897,497
Research and development 4,256,634 2,415,277
Total operating expenses 5,759,152 3,312,774
Interest income, net 1,225,692 49,075
Net loss (4,533,460) (3,263,699)
Non-cash preferred stock charge -- 16,875,115
Net loss attributable to
common stockholders $(4,533,460) $(20,138,814)
Basic and diluted net loss
per common share $(0.16) $(3.44)
Shares used in computing basic and
diluted net loss per common share 27,838,577 5,856,422
Pro forma net loss per common shares --
basic and diluted $ -- $(1.36)
Pro forma weighted average common
shares outstanding--basic and diluted -- 14,822,456
March 31, December 31,
Cash and cash equivalents $ 87,701,155 $ 92,350,583
Prepaid expenses 317,289 198,144
Accrued interest receivable 5,764 113,160
Other current assets 9,091 9,091
Total current assets 88,033,299 92,670,978
Equipment, net of
accumulated depreciation 174,555 158,780
Total assets $ 88,207,854 $ 92,829,758
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $449,604 $128,329
Accrued expenses 2,337,598 3,633,531
Total current liabilities 2,787,202 3,761,860
Total stockholders' equity 85,420,652 89,067,898
Total liabilities and
shareholders' equity $ 88,207,854 $ 92,829,758
Chief Financial Officer, of POZEN
Kathy Brunson of FRB Weber Shandwick