Pozen Inc. First-Quarter Results Meet Expectations; Initiates Six-Month Mouse Carcinogenicity Study; Announces Positive Results for Mt 400 Study

Apr 30, 2001, 01:00 ET from POZEN Inc.

    CHAPEL HILL, N.C., April 30 /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 first quarter ended
 March 31, 2001.  The financial performance met management's expectations.
     POZEN is a development-stage company that did not record revenues for the
 first quarter of 2001 or during 2000.
     For the first quarter of 2001, the company had operating expenses of
 $5.0 million compared with $2.7 million for the 2000 first quarter, excluding
 the non-cash amortization of deferred compensation.  The non-cash amortization
 of deferred compensation in connection with employee stock options grants was
 $802,000 and $657,000 for the 2001 and 2000 periods, respectively.
     POZEN's net loss attributable to common stockholders was $4.5 million, or
 $0.16 per common share, for the quarter ended March 31, 2001 compared with
 $3.3 million, or $0.56 per common share, for the 2000 quarter, excluding a
 charge related to preferred stock sold in March 2000.  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 quarter of 2000 would have been $1.36 per common share.  Excluding the
 charge related to preferred stock sold in March 2000, POZEN's pro forma net
 loss per share would have been $0.22 for the quarter ended March 31, 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
 operating expenses were higher due to increased clinical trial activities.  We
 expected that our operating expenses, 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."
 
     Company Update
     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 longer-lasting relief
 for migraine sufferers, while MT 500 is a product candidate for the
 prophylactic treatment of migraine.
     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.
     "We continue to be pleased by the clinical performance of MT 100," Dr.
 Plachetka said.  "Because we see a substantial market opportunity with MT 100,
 we intend to commence at least one additional study that has the potential to
 expand labeling regarding MT 100's efficacy relative to other approved
 migraine treatments."
     Dr. Plachetka also announced that the FDA has agreed to accept, and POZEN
 has just initiated, a six-month P53 transgenic mouse carcinogenicity study
 with MT 100 in lieu of the standard two-year mouse study.  Dr. Plachetka added
 that the company is continuing discussions with the FDA regarding additional
 carcinogenicity testing requirements.
     With respect to MT 400, Dr. Plachetka stated that the data analyses from
 the 900-patient Phase II study should be completed soon.  However, the initial
 evaluation indicates that the substantial advantage seen with MT 400 over
 triptan therapy in a pilot study has been confirmed with a high degree of
 statistical significance.
     Dr. Plachetka confirmed that discussions continue with parties interested
 in commercializing MT 100 and MT 300 with the goal of finalizing a deal during
 2001.  Dr. Plachetka also noted that POZEN is continuing to evaluate new
 product opportunities in other therapeutic areas using its "license back"
 model and continuing to explore the feasibility of 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 March 31, 2001 we had
 $87.7 million in cash and equivalents.  For the second quarter, we expect our
 cash operating expenses will be in the range of $4.5 to $5.5 million.  We
 continue to expect that our cash operating expenses during 2001 will exceed
 $25 million for the year."
 
     First-Quarter Conference Call
     POZEN will hold a conference call to discuss first-quarter results and
 management's outlook for the year at 11:00 a.m. EDT on Monday, April 30, 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-
 looking statements.
 
                   POZEN is on the Internet at www.pozen.com
 
 
                                   POZEN Inc.
                            Statements of Operations
                                  (Unaudited)
 
 
                                                      Three Months Ended
                                                            March 31,
                                                     2001            2000
     Operating expenses:
       General and administrative                  $1,502,518       $897,497
       Research and development                     4,256,634      2,415,277
     Total operating expenses                       5,759,152      3,312,774
     Interest income, net                           1,225,692         49,075
     Net loss                                      (4,533,460)    (3,263,699)
 
     Non-cash preferred stock charge                       --     16,875,115
 
     Net loss attributable to
       common stockholders                        $(4,533,460)  $(20,138,814)
 
     Basic and diluted net loss
       per common share                               $(0.16)         $(3.44)
 
     Shares used in computing basic and
       diluted net loss per common share           27,838,577      5,856,422
 
     Pro forma net loss per common shares --
       basic and diluted                                $  --        $(1.36)
 
     Pro forma weighted average common
       shares outstanding--basic and diluted               --     14,822,456
 
 
                                   POZEN Inc.
                                 Balance Sheet
                                  (Unaudited)
 
                                                   March 31,     December 31,
                                                      2001           2000
                                       ASSETS
     Current assets:
       Cash and cash equivalents                 $ 87,701,155   $ 92,350,583
       Prepaid expenses                               317,289        198,144
       Accrued interest receivable                      5,764        113,160
       Other current assets                             9,091          9,091
        Total current assets                       88,033,299     92,670,978
     Equipment, net of
       accumulated depreciation                       174,555        158,780
         Total assets                            $ 88,207,854   $ 92,829,758
 
 
 
         LIABILITIES AND STOCKHOLDERS' EQUITY
     Current liabilities:
       Accounts payable                              $449,604       $128,329
       Accrued expenses                             2,337,598      3,633,531
         Total current liabilities                  2,787,202      3,761,860
     Total stockholders' equity                    85,420,652     89,067,898
       Total liabilities and
         shareholders' equity                    $ 88,207,854   $ 92,829,758
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X46077574
 
 

SOURCE POZEN Inc.
    CHAPEL HILL, N.C., April 30 /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 first quarter ended
 March 31, 2001.  The financial performance met management's expectations.
     POZEN is a development-stage company that did not record revenues for the
 first quarter of 2001 or during 2000.
     For the first quarter of 2001, the company had operating expenses of
 $5.0 million compared with $2.7 million for the 2000 first quarter, excluding
 the non-cash amortization of deferred compensation.  The non-cash amortization
 of deferred compensation in connection with employee stock options grants was
 $802,000 and $657,000 for the 2001 and 2000 periods, respectively.
     POZEN's net loss attributable to common stockholders was $4.5 million, or
 $0.16 per common share, for the quarter ended March 31, 2001 compared with
 $3.3 million, or $0.56 per common share, for the 2000 quarter, excluding a
 charge related to preferred stock sold in March 2000.  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 quarter of 2000 would have been $1.36 per common share.  Excluding the
 charge related to preferred stock sold in March 2000, POZEN's pro forma net
 loss per share would have been $0.22 for the quarter ended March 31, 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
 operating expenses were higher due to increased clinical trial activities.  We
 expected that our operating expenses, 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."
 
     Company Update
     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 longer-lasting relief
 for migraine sufferers, while MT 500 is a product candidate for the
 prophylactic treatment of migraine.
     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.
     "We continue to be pleased by the clinical performance of MT 100," Dr.
 Plachetka said.  "Because we see a substantial market opportunity with MT 100,
 we intend to commence at least one additional study that has the potential to
 expand labeling regarding MT 100's efficacy relative to other approved
 migraine treatments."
     Dr. Plachetka also announced that the FDA has agreed to accept, and POZEN
 has just initiated, a six-month P53 transgenic mouse carcinogenicity study
 with MT 100 in lieu of the standard two-year mouse study.  Dr. Plachetka added
 that the company is continuing discussions with the FDA regarding additional
 carcinogenicity testing requirements.
     With respect to MT 400, Dr. Plachetka stated that the data analyses from
 the 900-patient Phase II study should be completed soon.  However, the initial
 evaluation indicates that the substantial advantage seen with MT 400 over
 triptan therapy in a pilot study has been confirmed with a high degree of
 statistical significance.
     Dr. Plachetka confirmed that discussions continue with parties interested
 in commercializing MT 100 and MT 300 with the goal of finalizing a deal during
 2001.  Dr. Plachetka also noted that POZEN is continuing to evaluate new
 product opportunities in other therapeutic areas using its "license back"
 model and continuing to explore the feasibility of 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 March 31, 2001 we had
 $87.7 million in cash and equivalents.  For the second quarter, we expect our
 cash operating expenses will be in the range of $4.5 to $5.5 million.  We
 continue to expect that our cash operating expenses during 2001 will exceed
 $25 million for the year."
 
     First-Quarter Conference Call
     POZEN will hold a conference call to discuss first-quarter results and
 management's outlook for the year at 11:00 a.m. EDT on Monday, April 30, 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-
 looking statements.
 
                   POZEN is on the Internet at www.pozen.com
 
 
                                   POZEN Inc.
                            Statements of Operations
                                  (Unaudited)
 
 
                                                      Three Months Ended
                                                            March 31,
                                                     2001            2000
     Operating expenses:
       General and administrative                  $1,502,518       $897,497
       Research and development                     4,256,634      2,415,277
     Total operating expenses                       5,759,152      3,312,774
     Interest income, net                           1,225,692         49,075
     Net loss                                      (4,533,460)    (3,263,699)
 
     Non-cash preferred stock charge                       --     16,875,115
 
     Net loss attributable to
       common stockholders                        $(4,533,460)  $(20,138,814)
 
     Basic and diluted net loss
       per common share                               $(0.16)         $(3.44)
 
     Shares used in computing basic and
       diluted net loss per common share           27,838,577      5,856,422
 
     Pro forma net loss per common shares --
       basic and diluted                                $  --        $(1.36)
 
     Pro forma weighted average common
       shares outstanding--basic and diluted               --     14,822,456
 
 
                                   POZEN Inc.
                                 Balance Sheet
                                  (Unaudited)
 
                                                   March 31,     December 31,
                                                      2001           2000
                                       ASSETS
     Current assets:
       Cash and cash equivalents                 $ 87,701,155   $ 92,350,583
       Prepaid expenses                               317,289        198,144
       Accrued interest receivable                      5,764        113,160
       Other current assets                             9,091          9,091
        Total current assets                       88,033,299     92,670,978
     Equipment, net of
       accumulated depreciation                       174,555        158,780
         Total assets                            $ 88,207,854   $ 92,829,758
 
 
 
         LIABILITIES AND STOCKHOLDERS' EQUITY
     Current liabilities:
       Accounts payable                              $449,604       $128,329
       Accrued expenses                             2,337,598      3,633,531
         Total current liabilities                  2,787,202      3,761,860
     Total stockholders' equity                    85,420,652     89,067,898
       Total liabilities and
         shareholders' equity                    $ 88,207,854   $ 92,829,758
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X46077574
 
 SOURCE  POZEN Inc.