|POZEN Inc. Releases Third-Quarter Results; Begins Two Clinical Trials|
CHAPEL HILL, N.C., Oct. 25 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, today announced results for the third quarter and nine months ended September 30, 2001.
POZEN is a development-stage company that did not record revenues for the third quarter of 2001 or 2000.
For the third quarter of 2001, the company had operating expenses of $4.7 million compared with $7.9 million for the 2000 third quarter, excluding the non-cash amortization of deferred compensation. The non-cash amortization of deferred compensation in connection with employee stock option grants was $785,000 and $869,000 for the 2001 and 2000 periods, respectively. The decrease in operating expenses was due primarily to lower costs associated with the development of MT 100, which were at their highest historical level during the three months ended September 30, 2000 as a result of three Phase III clinical trials nearing completion.
POZEN's net loss attributable to common stockholders was $4.8 million, or $0.17 per common share, for the quarter ended September 30, 2001, compared with $8.6 million, or $1.45 per common share, for the 2000 third quarter, excluding a non-cash charge related to preferred stock sold in August 2000 and dividends payable on preferred stock of $439,000. The charge related to the preferred stock sales was a non-cash charge of $10.7 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 stock into common stock as of the date of the original issuance, the loss for the third quarter of 2000, excluding dividends on preferred stock, would have been $1.00 per common share. Excluding the charge related to preferred stock sold in August 2000 and dividends on preferred stock, POZEN's pro forma net loss per share would have been $0.43 for the quarter ended September 30, 2000.
POZEN did not record revenues for the nine months ended September 30, 2001 or during the same period of 2000.
For the first nine months of 2001, the company had operating expenses of $14.3 million compared with $15.9 million for the 2000 nine-month period, excluding the non-cash amortization of deferred compensation. The non-cash amortization of deferred compensation in connection with employee stock option grants was $2.4 million and $2.2 million for the 2001 and 2000 periods, respectively. The decreased operating expenses for the first nine months of 2001 compared to the first nine months of 2000 reflect the quarter's lower clinical trial costs associated with MT 100.
POZEN's net loss attributable to common stockholders was $13.7 million, or $0.49 per common share, for the nine months ended September 30, 2001 compared with $17.6 million, or $3.01 per common share, for the 2000 nine-month period, excluding non-cash charges related to preferred stock sold in March and August 2000 and dividends payable on preferred stock of $830,000. 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 stock into common stock as of the date of the original issuance, the loss for the first nine months of 2000 would have been $2.59 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 $0.99 for the nine months ended September 30, 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.
John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive officer, announced that the company commenced two significant clinical trials in the third quarter -- an additional comparator trial for potential expanded labeling for MT 100 and the first Phase III pivotal trial for MT 300.
Dr. Plachetka confirmed that POZEN is on schedule to complete the six- month, in-life portion of the P53 transgenic mouse carcinogenicity study for MT 100 during November and to submit the report to the Food and Drug Administration (FDA) in the first quarter of 2002.
Dr. Plachetka also announced that during the third quarter Paul A. Ossi joined POZEN as Senior Vice President for Regulatory and Project Management. "Having been involved with the approval of over 25 drugs while employed at, among others, PPD, Rhone Poulenc and Glaxo, Paul brings POZEN a wealth of experience in guiding products through all phases of the regulatory process," said Dr. Plachetka.
In addition, Dr. Plachetka stated that POZEN believes it has sufficient cash to fund the development of its current product portfolio. "At September 30, 2001, we had $80.2 million in cash and equivalents. We expect that our cash operating expenses for the 2001 fiscal year will be slightly in excess of $20 million."
Third-Quarter Conference Call
POZEN will hold a conference call to discuss third-quarter results and its management's outlook for the remainder of the year at 11:00 a.m. EDT on Thursday, October 25, 2001. 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 $2.0 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 June 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. Statement of Operations (Unaudited)
Three Months Ended Nine Months Ended September 30, September 30, 2001 2000 2001 2000 Operating expenses: General and administrative $1,465,360 $1,238,735 $4,554,486 $3,288,752 Research and development 4,059,084 7,550,640 12,110,853 14,847,661 Total operating expenses 5,524,444 8,789,375 16,665,339 18,136,413 Interest income, net 718,458 235,237 2,916,975 540,049 Net loss (4,805,986) (8,554,138) (13,748,364) (17,596,364) Deemed dividend to preferred stockholders - 10,741,990 - 27,617,105 Preferred stock dividends - 439,307 - 829,882 Net loss attributable to common stockholders $(4,805,986) $(19,735,435) $(13,748,364) $(46,043,351) Basic and diluted net loss per common share $(0.17) $(3.35) $(0.49) $(7.87) Shares used in computing basic and diluted net loss per common share 27,964,435 5,887,246 27,906,237 5,850,520 Pro forma net loss per common share-basic and diluted $(1.00) $(2.59) Pro forma weighted average common shares outstanding -basic and diluted 19,737,305 17,790,301 POZEN Inc. Balance Sheet (Unaudited)
September 30, December 31, 2001 2000 ASSETS Current assets: Cash and cash equivalents $80,208,331 $92,350,583 Prepaid expenses 139,924 198,144 Accrued interest receivable 1,399 113,160 Other current assets 8,000 9,091 Total current assets 80,357,654 92,670,978 Equipment, net of accumulated depreciation 171,085 158,780 Total assets $80,528,739 $92,829,758 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $71,994 $128,329 Accrued expenses 2,655,269 3,633,531 Total current liabilities 2,727,263 3,761,860 Total stockholders' equity 77,801,476 89,067,898 Total liabilities and stockholders' equity $80,528,739 $92,829,758