POZEN Reports Second Quarter Results.Business Editors CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 5, 2003 POZEN Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :POZN), a pharmaceutical company developing therapeutic advancements in a cost effective manner, today announced results for the second quarter ended June 30, 2003. Second-Quarter Results POZEN is a development-stage company that did not record revenues for the second quarter of 2003 or 2002. For the second quarter of 2003, the company reported total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. of $4.8 million compared to $6.9 million in the second quarter of 2002. Operating expenses excluding the non-cash amortization of deferred compensation were $4.7 million in the second quarter of 2003 compared to $6.2 million in the second quarter of 2002. The non-cash amortization of deferred compensation in connection with employee stock option grants was $143,000 and $736,000 for the 2003 and 2002 three-month periods, respectively. The 2003 second quarter decrease in operating expenses was due primarily to a reduced level of research and development activities for MT 300 and MT 400, offset by an increase in costs associated with the licensing of MT 400 and pre-marketing activities for MT 100 and MT 300. POZEN's net loss attributable to common stockholders was $4.7 million, or $0.17 per common share, for the quarter ended June 30, 2003 compared to $6.6 million, or $0.24 per common share, for the 2002 quarter. At June 30, 2003, the company had approximately $42 million in cash and cash equivalents. Six Month Results POZEN is a development-stage company that did not record revenues for the six months ended June 30, 2003 or during 2002. For the first six months of 2003, the company reported total operating expenses of $9.8 million compared to $14.2 million for the same period of 2002. Operating expenses excluding the non-cash amortization of deferred compensation were $9.4 million compared to $12.7 million for the same period of 2002. The non-cash amortization of deferred compensation in connection with employee stock option grants was $422,000 and $1.5 million for the 2003 and 2002 six-month periods, respectively. The decrease in operating expenses was due primarily to a reduced level of research and development activities for MT 100, MT 300, and MT 400, offset by an increase in costs associated with the licensing of MT 400 and pre-marketing activities for MT 100 and MT 300. POZEN's net loss attributable to common stockholders was $9.5 million, or $0.34 per common share, for the six-month period ended June 30, 2003 as compared to $13.6 million, or $0.49 per common share, for the same period of 2002. Business Highlights POZEN submitted a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in July 2003 for MT 100. The FDA has agreed to review the NDA and accept POZEN's filing of the results of the rat carcinogenicity carcinogenicity /car·ci·no·ge·nic·i·ty/ (kahr?si-no-je-nis´i-te) the ability or tendency to produce cancer. carcinogenicity the ability or tendency to produce cancer. study in early 2004. MT 100 is being developed as an oral first-line therapy for the treatment of migraine migraine (mī`grān), headache characterized by recurrent attacks of severe pain, usually on one side of the head. It may be preceded by flashes or spots before the eyes or a ringing in the ears, and accompanied by double vision, nausea, . 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 European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. triptan trip·tan n. Any of a class of drugs that act as agonists of serotonin, result in cranial vasoconstriction, and are used for the prophylaxis and treatment of migraine headaches. market on a Euro basis. POZEN and GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) announced in June 2003 that they signed an agreement for the development and commercialization of proprietary combinations of a triptan and a long-acting non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. (NSAID NSAID: see nonsteroidal anti-inflammatory drug. ) that may improve the effectiveness of acute treatment and provide sustained relief for patients suffering from migraine headaches Migraine Headache Definition Migraine is a type of headache marked by severe head pain lasting several hours or more. Description Migraine is an intense and often debilitating type of headache. . The combinations covered by the agreement are among the combinations that POZEN has referred to as MT 400 technology. More recently, POZEN announced in July 2003, that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R. has expired ex·pire v. ex·pired, ex·pir·ing, ex·pires v.intr. 1. To come to an end; terminate: My membership in the club has expired. 2. , allowing the GSK and POZEN migraine collaboration to proceed, and triggering POZEN's right to receive $25 million in initial payments by GSK, of which approximately $3.6 million will be recognized by POZEN as revenue in the second half of 2003. POZEN strengthened its intellectual property position and announced that it recently received a new patent in July 2003 for its MT 400 technology. The patent provides additional claims relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc pharmaceutical compositions and treatment methods that can be used for migraine patients. In an effort 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, an NSAID. POZEN will explore the development of novel product candidates containing lornoxicam alone or in combination with other active ingredients An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. for pain or other indications. In June 2003, POZEN presented data at the American Headache headache Pain in the upper portion of the head. Episodic tension headaches are the most common, usually causing mild to moderate pain on both sides. They result from sustained contraction of face and neck muscles, often due to fatigue, stress, or frustration. Society's 45th Annual Scientific Meeting. One of the presentations highlighted data from a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA study, demonstrating that MT 300 is effective in providing sustained pain relief for the acute treatment of migraine. MT 300 is being developed as a new, improved formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of dihydroergotamine (DHE DHE Dihydroergotamine (anti-migraine drug) DHE Design Human Engineering DHE Dependable Highway Express (Los Angeles, CA) DHE dihematoporphyrin ether DHE Dehacked (Doom game utility) ) in a convenient pre-filled syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. that is suitable for at-home use. "Over the last several months, we signed two major development and commercialization deals with GSK and Nycomed for our novel migraine product candidates, submitted an NDA for MT 100, and signed an exclusive option agreement for lornoxicam, which may allow us to broaden our portfolio of medicines and move into a new therapeutic area," said John R. Plachetka, Pharm.D., chairman, president, and chief executive officer of POZEN. "These achievements demonstrate our ability to deliver and will drive growth for POZEN. I am extremely proud of our team for their hard work and dedication." Financial Guidance For the third quarter of 2003, POZEN expects total revenue to be approximately $1.8 million. POZEN expects total operating expenses for the third quarter of 2003 to be in the range of $5.6 million to $6.6 million, including non-cash deferred compensation of $66,000. For the 2003 year, POZEN expects total revenue to be approximately $3.6 million. POZEN expects total operating expenses for the 2003 year to be in the range of $19.5 million to $21.5 million, including non-cash deferred compensation of $510,000. Second-Quarter Results Conference Call POZEN will hold a conference call to discuss second-quarter results and management's outlook at 11:00 a.m. Eastern time on Tuesday, August 5, 2003. The call can be accessed live and will be available for replay over the Internet via www.pozen.com. About POZEN POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. Product development efforts are focused on diseases with unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs where POZEN can improve efficacy, safety, and/or patient convenience. POZEN has development and commercial alliances with GlaxoSmithKline and Nycomed. The company's common stock is traded on The Nasdaq Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " within the meaning of the "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 FDA approval of our product candidates, 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 Form 10-Q See 10-Q. for the quarterly period ended March 31, 2003 under "Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial 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. Financial Tables to Follow.
POZEN Inc.
Statement of Operations
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------ -------------------------
2003 2002 2003 2002
----------- ----------- ----------- ------------
Operating
expenses:
General and
administrative $ 2,921,052 $ 1,683,405 $ 4,784,203 $ 3,440,906
Research and
development 1,882,944 5,223,281 4,995,808 10,802,725
----------- ----------- ----------- ------------
Total operating
expenses 4,803,996 6,906,686 9,780,011 14,243,631
Interest income,
net 123,292 281,937 266,561 598,609
----------- ----------- ----------- ------------
Net loss
attributable to
common
stockholders $(4,680,704) $(6,624,749) $(9,513,450) $(13,645,022)
=========== =========== =========== ============
Basic and diluted
net loss per
common share $ (0.17) $ (0.24) $ (0.34) $ (0.49)
=========== =========== =========== ============
Shares used in
computing basic
and diluted net
loss per common
share 28,270,902 28,077,945 28,210,610 28,058,130
=========== =========== =========== ============
POZEN Inc.
Balance Sheet
(Unaudited)
June 30, December 31,
2003 2002
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 41,938,347 $ 50,056,251
Prepaid expenses and other current
assets 1,298,000 553,371
------------- -------------
Total current assets 43,236,347 50,609,622
Equipment, net of accumulated
depreciation 376,947 425,369
------------- -------------
Total assets $ 43,613,294 $ 51,034,991
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 403,033 $ 179,374
Accrued expenses 2,308,195 1,657,074
------------- -------------
Total current liabilities 2,711,228 1,836,448
Long-term liabilities:
Deferred revenue 500,000 -
------------- -------------
Total liabilities 3,211,228 1,836,448
Total stockholders' equity 40,402,066 49,198,543
------------- -------------
Total liabilities and stockholders'
equity $ 43,613,294 $ 51,034,991
============= =============
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