|POZEN Inc. Second-Quarter Results Meet Expectations|
CHAPEL HILL, N.C., July 26 /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 second quarter and six months ended June 30, 2001. The financial performance met management's expectations.
POZEN is a development-stage company that did not record revenues for the second quarter of 2001 or 2000.
For the second quarter of 2001, the company had operating expenses of $4.6 million compared with $5.4 million for the 2000 second quarter, excluding the non-cash amortization of deferred compensation. The non-cash amortization of deferred compensation in connection with employee stock option grants was $787,000 and $652,000 for the 2001 and 2000 periods, respectively.
POZEN's net loss attributable to common stockholders was $4.4 million, or $0.16 per common share, for the quarter ended June 30, 2001 compared with $5.8 million, or $0.98 per common share, for the 2000 quarter, excluding dividends on preferred stock of $391,000.
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 second quarter of 2000, excluding dividends on preferred stock, would have been $0.31 per common share.
POZEN did not record revenues for the six months ended June 30, 2001 or during 2000.
For the first six months of 2001, the company had operating expenses of $9.6 million compared with $8.0 million for the 2000 six-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 $1.6 million and $1.3 million for the 2001 and 2000 periods, respectively. The increased operating expenses during the first six months of 2001 compared to 2000 resulted from the increased clinical development costs associated with MT 300 and MT 400, and increased operational infrastructure, offset by decreased MT 100 clinical trial costs.
POZEN's net loss attributable to common stockholders was $8.9 million, or $0.32 per common share, for the six months ended June 30, 2001 compared with $9.0 million, or $1.54 per common share, for the 2000 six-month period, excluding a charge related to preferred stock sold in March 2000 and dividends on preferred stock of $391,000. The charge related to the preferred stock sales was a non-cash charge of $16.9 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 six months of 2000 would have been $1.56 per common share. Excluding the charge related to preferred stock sold in March 2000 and dividends on preferred stock, POZEN's pro forma net loss per share would have been $0.54 for the six months ended June 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 following schedule.
John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive officer, noted that the company's performance was in line with management's expectations. ``As we anticipated, our quarter-over-quarter expenses were lower due to the completion of several large Phase III clinical trials for MT 100 that were underway in the second quarter of 2000. We expected that our operating expenses during the second quarter, excluding the non-cash amortization of deferred compensation, would run between $4.5 million and $5.5 million for the quarter, and they fell within that range.''
POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.0 billion this year. The company has four products in development. Its lead product candidate, MT 100, is intended to be a first-line, oral treatment. MT 300 is being developed for relief of severe migraine. MT 400 is designed to provide fast and long lasting relief for migraine sufferers, while MT 500 is a product candidate for the prophylactic treatment of migraine. This portfolio serves distinct segments of the migraine market.
MT 100 has completed all planned Phase III pivotal clinical trials. MT 300 is expected to enter Phase III clinical testing in the third quarter of 2001. MT 400 has completed one Phase II clinical study and MT 500 is in initial clinical trials.
Dr. Plachetka noted that POZEN has submitted data from four additional genotoxicity studies in support of its request that the Food and Drug Administration reconsider the need for the company to conduct a two-year carcinogenicity study of the effects of MT 100 prior to approval of the MT 100 New Drug Application.
With respect to MT 500, Dr. Plachetka announced that POZEN had commenced its Phase I Tolerance study in June as scheduled.
Dr. Plachetka also noted that POZEN continues to evaluate new product opportunities using both its ``license back'' model as well as new, self- invented combination products.
Dr. Plachetka stated that POZEN believes it has sufficient cash to fund the development of its current product portfolio. ``At June 30, 2001, we had $83.3 million in cash and equivalents. For the third quarter, we expect our cash operating expenses will be in the range of $5.0 to $6.0 million. For the year we now expect that our cash operating expenses are more likely to be slightly below $25.0 million.''
Second-Quarter Conference Call
POZEN will hold a conference call to discuss second-quarter results and management's outlook for the remainder of the year at 11:00 a.m. EDT on Thursday, July 26, 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. The company's initial focus is migraine, where it has built a robust portfolio of four product candidates through a combination of innovation and in-licensing. 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 Annual Report
on Form 10-K/A 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-
POZEN is on the Internet at www.pozen.com . POZEN Inc. Statement of Operations (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2001 2000 2001 2000 Operating expenses: General and administrative $1,586,608 $1,185,985 $3,089,126 $2,083,482 Research and development 3,795,135 4,848,279 8,051,769 7,263,556 Total operating expenses 5,381,743 6,034,264 11,140,895 9,347,038 Interest income, net 972,825 255,737 2,198,517 304,812 Net loss (4,408,918) (5,778,527) (8,942,378) (9,042,226) Non-cash preferred stock charge - - - 16,875,115 Preferred stock dividends - 390,575 - 390,575 Net loss attributable to common stockholders $(4,408,918) $(6,169,102) $(8,942,378) $(26,307,916) Basic and diluted net loss per common share $(0.16) $(1.05) $(0.32) $(4.48) Shares used in computing basic and diluted net loss per common share 27,915,699 5,872,699 27,877,138 5,866,269 Pro forma net loss per common share- basic and diluted $(0.33) $(1.56) Pro forma weighted average common shares outstanding- basic and diluted 18,746,830 16,810,821 POZEN Inc. Balance Sheet (Unaudited) June 30, December 31, 2001 2000 ASSETS Current assets: Cash and cash equivalents $83,334,264 $92,350,583 Prepaid expenses 220,564 198,144 Accrued interest receivable 6,714 113,160 Other current assets 8,000 9,091 Total current assets 83,569,542 92,670,978 Equipment, net of accumulated depreciation 155,156 158,780 Total assets $83,724,698 $92,829,758 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $125,097 $128,329 Accrued expenses 1,777,311 3,633,531 Total current liabilities 1,902,408 3,761,860 Total stockholders' equity 81,822,290 89,067,898 Total liabilities and stockholders' equity $83,724,698 $92,829,758