|POZEN First-Quarter Results Meet Expectations|
CHAPEL HILL, N.C., Apr 25, 2002 /PRNewswire-FirstCall via COMTEX/ -- 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, 2002. The financial performance met management's expectations.
POZEN is a development stage company that did not record revenues for the first quarter of 2002 or during 2001.
For the first quarter of 2002, the company had operating expenses of $6.6 million compared with $5.0 million for the 2001 first quarter, excluding the non-cash amortization of deferred compensation. The non-cash amortization of deferred compensation in connection with employee stock option grants was $744,000 and $802,000 for the 2002 and 2001 periods, respectively. The growth in operating expenses was mainly due to increased costs associated with Phase III clinical trials for MT 300. At March 31, 2002, the company had $68.3 million in cash and equivalents to fund operations.
POZEN's net loss attributable to common stockholders was $7.0 million, or $0.25 per common share, for the quarter ended March 31, 2002, as compared to $4.5 million, or $0.16 per common share, for the 2001 quarter.
POZEN believes it has the largest portfolio of drugs in development for the treatment of migraine. The migraine market remains significantly underserved, as evidenced by a recently published study by Dr. Richard B. Lipton of the Albert Einstein College of Medicine. Notably, this study found that fewer than half of the migraine sufferers who took part in the study group sought medical attention. There are an estimated 27 million migraine sufferers in the U.S.
MT 100, an oral tablet designed for first-line migraine therapy, has consistently demonstrated its effectiveness in treating migraine with less risk of cardiovascular side effects compared to leading products on the market. The company successfully completed its second study comparing MT 100 to the leading migraine product in the U.S., Imitrex(R) 50 mg. The trial results indicated that a single tablet dose of MT 100 provided comparable efficacy to Imitrex 50 mg., confirming the results of a previously completed Phase III trial. The company also submitted the final results of its six- month mouse carcinogenicity study to the Food and Drug Administration (FDA). These results indicated that MT 100 was not carcinogenic in the test species, p53 transgenic mice. The in-life portion of the two-year rat carcinogenicity study will be completed in August 2003, with submission of the results to the FDA as soon as possible thereafter.
MT 300, an injectable product for the treatment of severe migraine, is undergoing its second and final planned Phase III clinical trial. Results from the recently completed first Phase III clinical trial are expected to be available in the second quarter of 2002. The company plans to submit a New Drug Application for MT 300 to the FDA by the end of the year.
MT 400, the company's next generation product candidate for the treatment of migraine, is being moved into full development this year by initiating key activities in toxicology and pharmaceutical development, and launching clinical trials.
"We have gotten off to a strong start in 2002. We continue to make significant progress in our clinical development programs and remain focused on completing the development of our initial migraine product candidates by finalizing clinical activities, filing appropriate registration applications in select countries, and securing the best partners to help us commercialize what we created," said John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN.
For the second quarter, POZEN expects that cash operating expenses will be in the range of $6.5 million to $7.5 million. This range excludes non-cash deferred compensation. For the year, the company continues to expect that operating expenses, excluding non-cash deferred compensation, will be between $23 million and $25 million.
First-Quarter Conference Call
POZEN will hold a conference call to discuss first-quarter results and management's outlook for the current quarter at 11:00 a.m. Eastern time on Thursday April 25, 2002. The call can be accessed live and will be available for replay over the Internet via www.ccbn.com. A replay will also be available on the company's website, www.pozen.com .
POZEN Inc. is a pharmaceutical development company committed to building a portfolio of products with significant commercial potential in select therapeutic areas. POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.8 billion this year. 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 our products; costs and delays in the development and FDA approval of our 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 for the twelve month period ended December 31, 2001 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 is on the Internet at www.pozen.com POZEN Inc. Statements of Operations (Unaudited) Three Months Ended March 31, 2002 2001 Operating expenses: General and administrative $1,757,501 $1,502,518 Research and development 5,579,444 4,256,634 Total operating expenses 7,336,945 5,759,152 Interest income, net 316,672 1,225,692 Net loss attributable to common stockholders $(7,020,273) $(4,533,460) Basic and diluted net loss per common share $(0.25) $(0.16) Shares used in computing basic and diluted net loss per common share 28,038,315 27,838,577 POZEN Inc. Balance Sheets (Unaudited) March 31, December 31, 2002 2001 ASSETS Current assets: Cash and cash equivalents $ 68,332,825 $ 73,958,724 Prepaid expenses 149,332 67,498 Other current assets 8,000 8,688 Total current assets 68,490,157 74,034,910 Equipment, net of accumulated depreciation 185,423 109,014 Total assets $ 68,675,580 $ 74,143,924 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $115,117 $194,138 Accrued expenses 4,068,113 3,328,881 Total current liabilities 4,183,230 3,523,019 Total stockholders' equity 64,492,350 70,620,905 Total liabilities and stockholders' equity $ 68,675,580 $ 74,143,924