POZEN Reports Fourth Quarter and Full-Year 2003 Results; POZEN Books Revenue and Achieves Positive Cash Flow in 2003.Business Editors/Health/Medical Writers CHAPEL HILL, N.C.--(BUSINESS WIRE)--Feb. 18, 2004 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), today announced results for the fourth quarter and year ended December 31, 2003. POZEN reported a net loss of $1.6 million, or $0.06 per share, for the fourth quarter of 2003 compared with a net loss of $5.7 million, or $0.20 per share, for the fourth quarter of 2002. POZEN's net loss was $14.9 million, or $0.52 per common share for 2003, as compared to $24.6 million or $0.87 per common share for 2002. For the fourth quarter of 2003, POZEN reported revenue of $1.8 million. Revenue for the twelve months ended December 31, 2003 totaled $3.7 million. POZEN did not report any revenue during 2002. Revenue for the fourth quarter and the twelve months ended December 31, 2003, resulted from the amortization of payments received under the licensing agreements for MT 100(TM), MT 300(TM), and MT 400(TM). 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. for the fourth quarter of 2003 were $3.6 million as compared to $5.9 million for the same period in 2002. The decrease in operating expenses was due primarily to a reduced level of research and development activities for MT 300 and MT 400. Operating expenses for 2003 decreased 25% to $19.1 million. The decrease in operating expenses for the year was due primarily to a reduced level of research and development activities for MT 300 and MT 400, offset by increased general and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. . The non-cash amortization of deferred compensation in connection with employee stock option grants was $0.5 million and $2.9 million for 2003 and 2002, respectively. At December 31, 2003, cash and cash equivalents totaled $60.5 million compared to $50.0 million at December 31, 2002. The increase in cash and cash equivalents resulted primarily from positive net cash provided by operating activities, or cash flow, for the year ended December 31, 2003. POZEN received $27.5 million in cash in 2003 from licensing agreements, of which $23.8 million will be recognized as revenue in future periods. "POZEN made considerable progress in 2003. We booked revenue and achieved positive cash flow for the first time in our company history. We submitted a New Drug Application for MT 100 and have secured commercial partnerships for several product candidates," said John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN. "We look forward to an equally exciting 2004 as we move our product candidates through development and the regulatory process, continue to work on securing commercial partnerships, and introduce new product candidates into our pipeline." Business Highlights MT 100 In January 2004, POZEN announced the results of a two-year 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 for MT 100. The Company believes the results of the study provided no evidence that the concomitant concomitant /con·com·i·tant/ (kon-kom´i-tant) accompanying; accessory; joined with another. concomitant adjective Accompanying, accessory, joined with another administration of maximum tolerated doses of metoclopramide metoclopramide /met·o·clo·pra·mide/ (met?o-klo´prah-mid) a dopamine receptor antagonist and prokinetic that stimulates gastric motility, used as the hydrochloride salt as an antiemetic, an adjunct in gastrointestinal radiology and and naproxen naproxen and naproxen sodium, potent nonsteroidal anti-inflammatory drugs (NSAID) used to alleviate the minor pain of arthritis, menstruation, headaches, and the like, and to reduce fever. produced any statistically significant differences in findings from those seen with metoclopramide alone. None of the tumors observed in the study were considered to be directly related to the administration of metoclopramide or naproxen; all were considered to be secondary to metoclopramide. The study report was submitted 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. ) and completes the MT 100 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 ) made by POZEN in July 2003. The NDA was accepted for filing by the FDA in October 2003 and is currently in review. MT 100 is being developed as an oral first-line therapy for the acute 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 October 2003, POZEN announced that it received a letter of comments from an advisory group to the Medicines and Healthcare Products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Marketing Authorization The right or permission to use a system resource; the process of granting access. See access control. Application for MT 100. POZEN plans to submit a response in the first quarter of 2004, including providing additional support for the benefits of the combination, to the comments raised by the advisory group. MT 300 In October 2003, POZEN announced that it received a not-approvable letter from the FDA related to its NDA for MT 300. POZEN is committed to working with the FDA and is preparing a complete response to address the issues raised in the letter. MT 300 is being developed as a new formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of dihydroergotamine mesylate dihydroergotamine mesylate D.H.E. 45, Dihydroergotamine-Sandoz (CA), Migranal Pharmacologic class: Alpha-adrenergic blocker Therapeutic class: Vasoconstrictor, vascular headache suppressant (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 prefilled syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. for the acute treatment of migraine. Financial Guidance For the first quarter of 2004, POZEN expects total revenue resulting from amortization of deferred revenue to be approximately $1.9 million. POZEN expects total operating expenses for the first quarter of 2004 to be in the range of $4 million to $5 million. For the 2004 year, POZEN expects total revenue from existing licensing agreements to be in the range of $23 million to $25 million. POZEN expects total operating expenses for the 2004 year to be in the range of $30 million to $34 million. These estimates of revenue and expenses reflect the expected commencement of Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. for MT 400 in 2004. Fourth-Quarter Results Webcast POZEN will hold a webcast to present fourth-quarter results and management's outlook on Wednesday, February 18, 2004 at 11:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay over the Internet Internet Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the 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 un·met adj. Not satisfied or fulfilled: unmet demands. 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 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/or FDA approval, or the failure to obtain such approval 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 Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarterly period ended September 30, 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.
POZEN Inc.
Statement of Operations
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
----------------------- -------------------------
2003 2002 2003 2002
----------------------- -------------------------
Revenue:
Licensing revenue $ 1,830,002 $ -- $ 3,717,000 $ --
Operating expenses:
General and
administrative 1,899,280 1,937,873 9,211,341 6,833,336
Research and
development 1,689,124 3,934,553 9,904,347 18,761,630
----------- ----------- ------------ ------------
Total operating
expenses 3,588,404 5,872,426 19,115,688 25,594,966
Other Income:
Interest income,
net 140,500 196,466 535,370 1,040,056
----------- ----------- ------------ ------------
Net loss attributable
to common
stockholders $(1,617,902)$(5,675,960)$(14,863,318)$(24,554,910)
=========== =========== ============ ============
Basic and diluted
net loss per
common share $ (0.06)$ (0.20)$ (0.52)$ (0.87)
=========== =========== ============ ============
Shares used in
computing basic and
diluted net loss
per common share 28,489,043 28,131,485 28,414,020 28,110,352
=========== =========== ============ ============
POZEN Inc.
Balance Sheet
(Unaudited)
December 31, December 31,
2003 2002
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 60,480,690 $ 50,056,251
Prepaid expenses and other current assets 698,209 553,371
------------- -------------
Total current assets 61,178,899 50,609,622
Equipment, net of accumulated depreciation 334,096 425,369
------------- -------------
Total assets $ 61,512,995 $ 51,034,991
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 579,903 $ 179,374
Accrued expenses 1,519,675 1,657,074
------------- -------------
Total current liabilities 2,099,578 1,836,448
Long-term liabilities:
Deferred revenue 23,782,978 --
------------- -------------
Total liabilities 25,882,556 1,836,448
Total stockholders' equity 35,630,439 49,198,543
------------- -------------
Total liabilities and stockholders'
equity $ 61,512,995 $ 51,034,991
============= =============
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