Exhibit 99.1
POZEN Reports Third Quarter 2003 Results; POZEN Reports Revenue for
the First Time in Company History
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Oct. 30, 2003--POZEN Inc.
(NASDAQ: POZN), today announced results for the third quarter ended
September 30, 2003.
POZEN reported a net loss of $3.7 million, or $0.13 per share, for
the third quarter of 2003 compared with a net loss of $5.2 million, or
$0.19 per share, for the third quarter of 2002. The company reported a
net loss of $13.2 million, or $0.47 per share, for the nine months
ended September 30, 2003 compared with a net loss of $18.9 million, or
$0.67 per share, for the same period in 2002.
POZEN reported revenue for the first time in the history of the
company. Revenue for the third quarter of 2003 totaled $1.9 million
resulting from the amortization of up-front payments received under
the licensing agreements for MT 100(TM), MT 300(TM), and MT 400(TM).
These agreements have terms that include up-front payments upon
contract signing and additional payments if and when certain product
development milestones are reached. The up-front payments are being
amortized over the period ending on the anticipated date of regulatory
approvals, as specified in the agreements relating to the product
candidates.
Total operating expenses for the third quarter of 2003 were $5.7
million, as compared to $5.5 million for the same period in 2002. For
the nine-month period, total operating expenses decreased 21% to $15.5
million, due primarily to a reduced level of research and development
activities for MT 300 and MT 400.
At September 30, 2003, cash and cash equivalents totaled $65
million compared with $50 million at December 31, 2002. The increase
in cash and cash equivalents resulted primarily from licensing fees
offset by expenses associated with operating activities.
Business Highlights
MT 100
In October 2003, POZEN announced that the New Drug Application
(NDA) submitted to the U.S. Food and Drug Administration (FDA) in July
2003 for MT 100 was accepted for filing. The FDA has agreed to review
the NDA and accept POZEN's filing of the results of a rat
carcinogenicity study in early 2004. MT 100 is being developed as an
oral first-line therapy for the treatment of migraine.
POZEN previously announced that it received a letter of comments
from an advisory group to the Medicines and Healthcare Products
Regulatory Agency (MHRA), relating to the Marketing Authorization
Application (MAA) for MT 100. POZEN intends to submit a response to
the comments raised by the advisory group. The Company will need to
satisfactorily address the issues raised, including providing
additional support for the benefits of the combination, in order to
obtain approval.
Results from a recent Phase IIIb study showed that early treatment
with MT 100 improves efficacy. The rate of sustained pain relief for
migraine patients taking MT 100 in the study nears 50%. In addition,
data was presented at the XI Congress of the International Headache
Society showing that a two-tablet dose of MT 100 appears to be more
effective in providing pain relief at two hours than a single tablet
dose of Imitrex(R) 50mg in migraine patients with nausea or severe
pain at baseline. MT 100 was also shown to be well tolerated in a
long-term safety study.
In July 2003, POZEN and Nycomed announced that they signed a
licensing agreement to commercialize MT 100 in four Nordic countries -
Denmark, Sweden, Norway, and Finland. The Nordic countries account for
approximately 18% of the European triptan market on a Euro basis.
MT 300
POZEN and Xcel Pharmaceuticals announced in September 2003 that
they signed a licensing agreement for the commercialization of MT 300,
an injectable product candidate for the treatment of migrane.
In October, POZEN announced that it had received a not-approvable
letter from the FDA related to its NDA for MT 300. The letter was
issued based on the FDA's conclusion that while MT 300 achieved the
primary endpoint, it failed to achieve statistical significance versus
placebo for the relief at two hours of the ancillary symptoms of
migraine (nausea, sensitivity to light, and sensitivity to sound). No
clinical safety issues were identified in the letter, nor were any
non-clinical issues cited as impacting the FDA's decision to issue the
not-approvable letter. POZEN is committed to working with the FDA and
will seek to resolve the issues raised in the letter as soon as
possible.
Other
As part of its continuing efforts to expand into new therapeutic
areas, POZEN announced in July 2003 that it signed an exclusive option
agreement with Nycomed, under which POZEN may acquire a license to
certain rights related to lornoxicam, a non-steroidal
anti-inflammatory drug or NSAID. POZEN will explore the development of
novel product candidates containing lornoxicam alone or in combination
with other active ingredients for pain or other indications.
Financial Guidance
For the fourth quarter of 2003, POZEN expects total revenue to be
approximately $2.1 million. POZEN expects total operating expenses for
the fourth quarter of 2003 to be in the range of $4.0 million to $5.0
million.
For the 2003 year, POZEN expects total revenue to be approximately
$4.0 million. POZEN expects total operating expenses for the 2003 year
to be in the range of $19.5 million to $20.5 million.
Third-Quarter Results Webcast
POZEN will hold a webcast to present third-quarter results and
management's outlook at 11:00 a.m. Eastern time on Thursday, October
30, 2003. The webcast can be accessed live and will be available for
replay over the Internet at www.pozen.com.
About POZEN
POZEN is a pharmaceutical company developing therapeutic
advancements in a cost effective manner. Product development efforts
are focused on diseases with unmet medical needs where POZEN can
improve efficacy, safety, and/or patient convenience. Since its
inception, POZEN has developed the largest and most advanced product
pipeline in the field of migraine. POZEN has development and
commercial alliances with GlaxoSmithKline, Xcel Pharmaceuticals, and
Nycomed. 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, or the
failure to obtain such approval of our product candidates,
uncertainties in clinical trial results, resulting in, among other
things, 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 Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2003 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-looking statements.
POZEN Inc.
Statement of Operations
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
----------------------- -------------------------
2003 2002 2003 2002
----------------------- -------------------------
Revenue:
Licensing revenue $ 1,886,998 $ - $ 1,886,998 -
Operating expenses:
General and
administrative 2,527,858 1,454,558 7,312,061 4,895,463
Research and
development 3,219,415 4,024,353 8,215,224 14,827,078
----------- ----------- ------------ ------------
Total operating
expenses 5,747,273 5,478,911 15,527,285 19,722,541
Other Income:
Interest income,net 128,309 244,982 394,871 843,591
----------- ----------- ------------ ------------
Net loss attributable
to common
stockholders $(3,731,966)$(5,233,929)$(13,245,416)$(18,878,950)
=========== =========== ============ ============
Basic and diluted
net loss per common
share $ (0.13)$ (0.19)$ (0.47)$ (0.67)
=========== =========== ============ ============
Shares used in
computing basic and
diluted net loss
per common share 28,407,093 28,100,495 28,276,105 28,072,252
=========== =========== ============ ============
POZEN Inc.
Balance Sheet
(Unaudited)
Sept. 30, Dec. 31
2003 2002
----------- -----------
ASSETS
Current assets:
Cash and cash equivalents $65,362,275 $50,056,251
Prepaid expenses and other current assets 79,739 553,371
----------- -----------
Total current assets 65,442,014 50,609,622
Equipment, net of accumulated depreciation 354,991 425,369
----------- -----------
Total assets $65,797,005 $51,034,991
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 451,170 $ 179,374
Accrued expenses 2,540,716 1,657,074
----------- -----------
Total current liabilities 2,991,886 1,836,448
Long-term liabilities:
Deferred revenue 25,612,980 -
----------- -----------
Total liabilities 28,604,866 1,836,448
Total stockholders' equity 37,192,139 49,198,543
----------- -----------
Total liabilities and stockholders' equity $65,797,005 $51,034,991
=========== ===========
CONTACT: POZEN
Matt Czajkowski, Chief Financial Officer, 919-913-1030
Lisa Barthelemy, Director, Investor Relations,
919-913-1044