|POZEN Inc. Releases Fourth-Quarter and Full-Year Results That Meet Expectations|
CHAPEL HILL, N.C., Feb 7, 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 fourth quarter and year ended December 31, 2001. The financial performance met management's expectations.
POZEN is a development-stage company that did not record revenues for the fourth quarter of 2001 or 2000.
For the fourth quarter of 2001, the company had operating expenses of $7.6 million compared with $5.2 million for the 2000 fourth quarter, excluding the non-cash amortization of deferred compensation. The non-cash amortization of deferred compensation in connection with employee stock option grants was $771,000 and $881,000 for the 2001 and 2000 periods, respectively. The increase in operating expenses was due primarily to increased costs associated with MT 300, which commenced Phase III clinical testing during the third quarter of 2001.
POZEN's net loss attributable to common stockholders was $8.0 million, or $0.28 per common share, for the fourth quarter of 2001, compared with a net loss of $4.8 million, or $0.20 per common share, for the 2000 fourth quarter, excluding dividends payable on preferred stock of $105,000.
On a pro forma basis that assumes the conversion of all outstanding preferred stock into common stock as of the date of the original issuance, the loss for the fourth quarter of 2000, excluding dividends on preferred stock, would have been $0.18 per common share.
Full-Year ResultsFor 2001 and prior years, POZEN did not record revenues.
Operating expenses for 2001 were $21.9 million compared with $21.2 million for 2000, excluding the non-cash amortization of deferred compensation. The non-cash amortization of deferred compensation in connection with employee stock option grants was $3.1 million for both the 2001 and 2000 periods.
POZEN's net loss attributable to common stockholders was $21.7 million, or $0.78 per common share, for 2001 compared with $22.4 million, or $2.17 per common share, for 2000, excluding non-cash charges related to preferred stock sold in March and August 2000 and dividends payable on preferred stock of $934,000. The charge related to the preferred stock sales was a non-cash charge of $27.6 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 preferred stock into common stock as of the date of the original issuance, the loss for 2000 would have been $2.56 per common share. Excluding the charge related to preferred stock sold in March and August 2000 and dividends payable on preferred stock, POZEN's pro forma net loss per share would have been $1.12 for 2000. POZEN's basic and diluted net loss per common share and pro forma net loss per common share are set forth in the schedule following this release.
POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.6 billion this year.
MT 100, POZEN's lead product candidate, is being developed as an oral, first-line treatment for migraine pain and associated symptoms. POZEN has completed all planned Phase III pivotal clinical trials for MT 100, which have consistently demonstrated its effectiveness. According to John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive officer, the company intends to submit the results of its six-month p53 mouse carcinogenicity study to the Food and Drug Administration in the next several weeks. POZEN announced recently that preliminary results of the six-month study indicate that MT 100 is not carcinogenic in the test species, transgenic p53 mice. Results from the ongoing two-year rat carcinogenicity study will be available in 2003.
Dr. Plachetka also confirmed that POZEN expects to complete its second comparator trial for potential expanded labeling for MT 100 in the clinic in the first quarter of 2002. In a clinical trial that was completed in August 2000, results showed that MT 100 provided comparable efficacy with fewer side effects when tested against Imitrex(R), the worldwide market leader.
MT 300, the company's injectable product for the treatment of severe migraine, is currently in two Phase III clinical trials. Dr. Plachetka confirmed that POZEN expects to complete its first Phase III trial in the clinic in the first quarter, with the second trial being completed in the clinic in the second quarter.
MT 400 is being developed for the acute treatment of migraine. Dr. Plachetka confirmed that POZEN expects to commence two Phase II dose ranging trials for MT 400 during 2002.
Dr. Plachetka also noted that the company continues to have active discussions with potential licensees for its product candidates. He also stated that POZEN continues to evaluate new product opportunities in other therapeutic areas.
In addition, Dr. Plachetka stated that POZEN believes it has sufficient cash to fund the development of its current product candidate portfolio. "At December 31, 2001, we had $74.0 million in cash and cash equivalents. For the first quarter of 2002, we expect our operating expenses will be in the range of $6.5 million to $7.5 million, depending upon when we start various trials. This range excludes non-cash deferred compensation. For the year, we expect that our operating expenses, again excluding non-cash deferred compensation, will be between $23.0 million and $25.0 million, given our expected completion of work on New Drug Applications for MT 100 and MT 300 and our planned expanding development activities relating to MT 400."
Fourth-Quarter Conference Call
POZEN will hold a conference call to discuss fourth-quarter results and management's outlook for the current quarter at 11:00 a.m. Eastern time on Thursday, February 7, 2002. 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. POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.6 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 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 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 Twelve Months Ended December 31, December 31, 2001 2000 2001 2000 Operating expenses: General and administrative $1,900,678 $1,533,350 $6,455,164 $4,822,102 Research and development 6,516,396 4,551,243 18,627,249 19,398,904 Total operating expenses 8,417,074 6,084,593 25,082,413 24,221,006 Interest income, net 462,930 1,304,329 3,379,905 1,844,378 Net loss (7,954,144) (4,780,264) (21,702,508) (22,376,628) Deemed dividend to preferred stockholders -- -- -- 27,617,105 Preferred stock dividends -- 104,596 -- 934,478 Net loss attributable to common stockholders $(7,954,144) $(4,884,860) $(21,702,508) $(50,928,211) Basic and diluted net loss per common share $(0.28) $(0.21) $(0.78) $(4.95) Shares used in computing basic and diluted net loss per common share 27,969,327 23,622,858 27,954,697 10,293,605 Pro forma net loss per common shares-basic and diluted* $(0.19) $(2.56) Pro forma weighted average common shares outstanding -basic and diluted* 26,328,444 19,915,147 *Assumes conversion of all outstanding preferred stock into common stock as of the date of the original issuance. POZEN Inc. Balance Sheet (Unaudited) December 31, December 31, 2001 2000 ASSETS Current assets: Cash and cash equivalents $73,958,724 $92,350,583 Prepaid expenses 67,498 198,144 Accrued interest receivable 688 113,160 Other current assets 8,000 9,091 Total current assets 74,034,910 92,670,978 Furniture and fixtures, net of accumulated depreciation 109,014 158,780 Total assets $74,143,924 $92,829,758 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $194,138 $128,329 Accrued expenses 3,328,881 3,633,531 Total current liabilities 3,523,019 3,761,860 Total stockholders' equity 70,620,905 89,067,898 Total liabilities and stockholders' equity $74,143,924 $92,829,758