BioMarin Announces First Quarter 2001 Financial Results

Apr 27, 2001, 01:00 ET from BioMarin Pharmaceutical Inc.

    NOVATO, Calif., April 27 /PRNewswire/ -- BioMarin Pharmaceutical Inc.
 (Nasdaq and SWX New Market: BMRN) today announced financial results for its
 first quarter ended March 31, 2001.  Revenues for the first quarter 2001 were
 $3.4 million, as compared to $3.3 million in the first quarter of 2000.  The
 net loss was $9.7 million ($0.26 per share, both basic and diluted) in the
 first quarter of 2001 compared to $11.7 million ($0.34 per share) for the
 first quarter of 2000.
     The net loss in the first quarter of 2001 was primarily the result of
 expenses due to the continued progress of BioMarin's three most advanced
 clinical and development programs: Aldurazyme (TM) for MPS-I, rhASB for MPS-
 VI, and Vibriolysin for burns.  The net loss in the first quarter of 2000
 included a $4.4 million charge associated with the closure of one of the
 Company's facilities.  The Company had $29.8 million in cash, cash equivalents
 and short-term investments at March 31, 2001.
 
     Recent Achievements
     Fredric D. Price, BioMarin's Chairman and Chief Executive Officer said,
 "Since the beginning of 2001, we have made significant progress in the
 development of our three lead product candidates.  I am pleased to highlight
 the following achievements."
     By April 25, 2001, all 45 MPS-I patients enrolled in the Phase III
 clinical trial of Aldurazyme had received at least eight of their planned 26
 weekly infusions, and all six MPS-VI patients enrolled in the Phase I clinical
 trial of rhASB had received at least 12 of their planned 24 weekly infusions.
     BioMarin completed the last major manufacturing milestone for Aldurazyme
 prior to the submission of a Biologics License Application (BLA) in the U.S.
 and Marketing Authorization Application (MAA) in Europe.  This key step
 involved the manufacture of the five required process qualification lots of
 Aldurazyme.
     The Company increased the amount of Aldurazyme that is produced at its
 cGMP manufacturing facility, implemented improved quality plant systems, and
 reduced the cost of formulated bulk enzyme.
     An article in the New England Journal of Medicine reported on positive
 clinical results from the first Aldurazyme clinical trial, which we believe
 suggest that Aldurazyme has potential to alleviate the primary symptoms of
 MPS-I.
     The European Commission designated Aldurazyme and rhASB for the treatment
 of MPS-I and MPS-VI, respectively, as orphan medicinal products in the
 European Community.  In the United States, the FDA previously granted BioMarin
 orphan drug as well as fast track designations for both Aldurazyme and rhASB.
     BioMarin exercised its option to acquire an exclusive worldwide license to
 intellectual property in relation to Vibriolysin, an enzyme that has
 demonstrated promising preclinical efficacy related to debridement (cleaning)
 of dead tissue associated with serious burns.
     Mr. Price concluded, "These accomplishments solidify our position as we
 prepare for the unblinding of data from our Phase III Aldurazyme and Phase I
 rhASB clinical trials in the second half of 2001 and the submission of an
 application to begin a Vibriolysin clinical trial by mid-year."
     BioMarin specializes in the development and commercialization of
 therapeutic enzyme products.  Since inception in 1997, BioMarin has applied
 its proprietary enzyme technology to develop products for lysosomal storage
 diseases and for the treatment of serious burns.  Glyko, Inc., a BioMarin
 subsidiary, provides analytical and diagnostic products and services in the
 area of carbohydrate biology.
 
     This press release contains forward-looking statements about the business
 prospects of BioMarin Pharmaceutical Inc., including the following potential
 future products:  Aldurazyme for MPS-I (including manufacturing performance),
 rhASB for MPS-VI and Vibriolysin for burn debridement.  These forward looking
 statements are predictions and involve risks and uncertainties such that
 actual results may differ materially from these statements.  Results may
 differ materially depending on the progress of BioMarin's product programs,
 the actual results of the current clinical trials, actions of regulatory
 authorities, including actions related to the application for the commencement
 of a clinical trial of Vibriolysin, availability of capital, future actions in
 the pharmaceutical market and developments by competitors, and those factors
 detailed in BioMarin's filings with the Securities and Exchange Commission
 such as 10Q, 10K and 8K reports.  Stockholders are urged not to place undo
 reliance on forward-looking statements, which speak only as of the date
 hereof.  BioMarin is under no obligation, and expressly disclaims any
 obligation, to update or alter any forward-looking statement, whether as a
 result of new information, future events or otherwise.
 
     Aldurazyme is a trademark of BioMarin/Genzyme LLC.  All rights reserved.
 
                         BioMarin Pharmaceutical Inc.
                          Consolidated Balance Sheet
 
                                 ($ Thousands)
 
                                                    March 31     December 31
                                                      2001          2000
    Assets                                        (unaudited)
     Current assets:
      Cash and cash equivalents                      $ 19,722       $ 16,530
      Short-term investments                           10,044         23,671
      Accounts receivable, net                            754          1,135
      Due from BioMarin/Genzyme LLC                     3,386          1,799
      Inventories                                         439            436
      Prepaid expenses                                  1,516            970
       Total current assets                            35,861         44,541
     Investment in BioMarin/Genzyme LLC                 (217)          1,482
     Property, plant and equipment, net                19,983         20,715
     Goodwill and other intangibles, net                9,333          9,862
     Deposits                                             483            333
       Total assets                                  $ 65,443       $ 76,933
 
     Liabilities and Stockholders' Equity
     Current liabilities:
      Accounts payable                                $ 1,616        $ 4,747
      Accrued liabilities                               1,992          2,109
      Notes payable - short-term                           29             27
       Total current liabilities                        3,637          6,883
 
     Long-term liabilities:
      Notes payable - long-term                            47             56
       Total long-term liabilities                         47             56
 
       Total liablities                                 3,684          6,939
 
     Stockholders' equity:
      Common stock                                         37             37
      Additional paid in capital                      155,220        153,940
      Common stock warrants and options                     -              -
      Deferred compensation                           (1,321)        (1,530)
      Notes from stockholders                         (1,964)        (1,940)
      Accumulated deficit                            (90,213)       (80,513)
       Total stockholders' equity                      61,759         69,994
       Total liabilities and stockholders' equity    $ 65,443       $ 76,933
 
 
                         BioMarin Pharmaceutical Inc.
                     Consolidated Statements of Operations
                                  (Unaudited)
 
                     ($ Thousands, except per share data)
 
                                                  Three Months Ended March 31,
    Revenues                                            2001           2000
      Revenues - products                               $ 692          $ 469
      Revenues - services                                  17             50
      Revenues from BioMarin/Genzyme LLC                2,691          2,756
      Revenues - other                                      -             23
       Total revenues                                   3,400          3,298
 
     Operating Costs and Expenses
      Cost of products                                    266            148
      Cost of services                                      5             33
      Research and development                          9,984          8,663
      Selling, general and administrative               2,203          1,996
      Carson Street closure                                 -          4,423
       Total operating costs and expenses              12,458         15,263
 
     Loss from operations                             (9,058)       (11,965)
 
     Interest income                                      468            788
     Interest expense                                     (2)            (2)
     Equity in loss of BioMarin/Genzyme LLC           (1,108)          (557)
 
     Net loss                                       $ (9,700)     $ (11,736)
 
     Loss per share, basic and diluted               $ (0.26)       $ (0.34)
 
     Weighted average common shares outstanding,
      basic and diluted                                37,052         35,015
 
 
      Contacts:
      Fredric D. Price
      Chairman and Chief Executive Officer
      BioMarin Pharmaceutical Inc.
      (415) 884-6700
 
      Investor Relations
      (415) 884-6777
 
      Sharon Karlsberg
      Director
      Feinstein Kean Healthcare
     (617) 577-8110
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X37781277
 
 

SOURCE BioMarin Pharmaceutical Inc.
    NOVATO, Calif., April 27 /PRNewswire/ -- BioMarin Pharmaceutical Inc.
 (Nasdaq and SWX New Market: BMRN) today announced financial results for its
 first quarter ended March 31, 2001.  Revenues for the first quarter 2001 were
 $3.4 million, as compared to $3.3 million in the first quarter of 2000.  The
 net loss was $9.7 million ($0.26 per share, both basic and diluted) in the
 first quarter of 2001 compared to $11.7 million ($0.34 per share) for the
 first quarter of 2000.
     The net loss in the first quarter of 2001 was primarily the result of
 expenses due to the continued progress of BioMarin's three most advanced
 clinical and development programs: Aldurazyme (TM) for MPS-I, rhASB for MPS-
 VI, and Vibriolysin for burns.  The net loss in the first quarter of 2000
 included a $4.4 million charge associated with the closure of one of the
 Company's facilities.  The Company had $29.8 million in cash, cash equivalents
 and short-term investments at March 31, 2001.
 
     Recent Achievements
     Fredric D. Price, BioMarin's Chairman and Chief Executive Officer said,
 "Since the beginning of 2001, we have made significant progress in the
 development of our three lead product candidates.  I am pleased to highlight
 the following achievements."
     By April 25, 2001, all 45 MPS-I patients enrolled in the Phase III
 clinical trial of Aldurazyme had received at least eight of their planned 26
 weekly infusions, and all six MPS-VI patients enrolled in the Phase I clinical
 trial of rhASB had received at least 12 of their planned 24 weekly infusions.
     BioMarin completed the last major manufacturing milestone for Aldurazyme
 prior to the submission of a Biologics License Application (BLA) in the U.S.
 and Marketing Authorization Application (MAA) in Europe.  This key step
 involved the manufacture of the five required process qualification lots of
 Aldurazyme.
     The Company increased the amount of Aldurazyme that is produced at its
 cGMP manufacturing facility, implemented improved quality plant systems, and
 reduced the cost of formulated bulk enzyme.
     An article in the New England Journal of Medicine reported on positive
 clinical results from the first Aldurazyme clinical trial, which we believe
 suggest that Aldurazyme has potential to alleviate the primary symptoms of
 MPS-I.
     The European Commission designated Aldurazyme and rhASB for the treatment
 of MPS-I and MPS-VI, respectively, as orphan medicinal products in the
 European Community.  In the United States, the FDA previously granted BioMarin
 orphan drug as well as fast track designations for both Aldurazyme and rhASB.
     BioMarin exercised its option to acquire an exclusive worldwide license to
 intellectual property in relation to Vibriolysin, an enzyme that has
 demonstrated promising preclinical efficacy related to debridement (cleaning)
 of dead tissue associated with serious burns.
     Mr. Price concluded, "These accomplishments solidify our position as we
 prepare for the unblinding of data from our Phase III Aldurazyme and Phase I
 rhASB clinical trials in the second half of 2001 and the submission of an
 application to begin a Vibriolysin clinical trial by mid-year."
     BioMarin specializes in the development and commercialization of
 therapeutic enzyme products.  Since inception in 1997, BioMarin has applied
 its proprietary enzyme technology to develop products for lysosomal storage
 diseases and for the treatment of serious burns.  Glyko, Inc., a BioMarin
 subsidiary, provides analytical and diagnostic products and services in the
 area of carbohydrate biology.
 
     This press release contains forward-looking statements about the business
 prospects of BioMarin Pharmaceutical Inc., including the following potential
 future products:  Aldurazyme for MPS-I (including manufacturing performance),
 rhASB for MPS-VI and Vibriolysin for burn debridement.  These forward looking
 statements are predictions and involve risks and uncertainties such that
 actual results may differ materially from these statements.  Results may
 differ materially depending on the progress of BioMarin's product programs,
 the actual results of the current clinical trials, actions of regulatory
 authorities, including actions related to the application for the commencement
 of a clinical trial of Vibriolysin, availability of capital, future actions in
 the pharmaceutical market and developments by competitors, and those factors
 detailed in BioMarin's filings with the Securities and Exchange Commission
 such as 10Q, 10K and 8K reports.  Stockholders are urged not to place undo
 reliance on forward-looking statements, which speak only as of the date
 hereof.  BioMarin is under no obligation, and expressly disclaims any
 obligation, to update or alter any forward-looking statement, whether as a
 result of new information, future events or otherwise.
 
     Aldurazyme is a trademark of BioMarin/Genzyme LLC.  All rights reserved.
 
                         BioMarin Pharmaceutical Inc.
                          Consolidated Balance Sheet
 
                                 ($ Thousands)
 
                                                    March 31     December 31
                                                      2001          2000
    Assets                                        (unaudited)
     Current assets:
      Cash and cash equivalents                      $ 19,722       $ 16,530
      Short-term investments                           10,044         23,671
      Accounts receivable, net                            754          1,135
      Due from BioMarin/Genzyme LLC                     3,386          1,799
      Inventories                                         439            436
      Prepaid expenses                                  1,516            970
       Total current assets                            35,861         44,541
     Investment in BioMarin/Genzyme LLC                 (217)          1,482
     Property, plant and equipment, net                19,983         20,715
     Goodwill and other intangibles, net                9,333          9,862
     Deposits                                             483            333
       Total assets                                  $ 65,443       $ 76,933
 
     Liabilities and Stockholders' Equity
     Current liabilities:
      Accounts payable                                $ 1,616        $ 4,747
      Accrued liabilities                               1,992          2,109
      Notes payable - short-term                           29             27
       Total current liabilities                        3,637          6,883
 
     Long-term liabilities:
      Notes payable - long-term                            47             56
       Total long-term liabilities                         47             56
 
       Total liablities                                 3,684          6,939
 
     Stockholders' equity:
      Common stock                                         37             37
      Additional paid in capital                      155,220        153,940
      Common stock warrants and options                     -              -
      Deferred compensation                           (1,321)        (1,530)
      Notes from stockholders                         (1,964)        (1,940)
      Accumulated deficit                            (90,213)       (80,513)
       Total stockholders' equity                      61,759         69,994
       Total liabilities and stockholders' equity    $ 65,443       $ 76,933
 
 
                         BioMarin Pharmaceutical Inc.
                     Consolidated Statements of Operations
                                  (Unaudited)
 
                     ($ Thousands, except per share data)
 
                                                  Three Months Ended March 31,
    Revenues                                            2001           2000
      Revenues - products                               $ 692          $ 469
      Revenues - services                                  17             50
      Revenues from BioMarin/Genzyme LLC                2,691          2,756
      Revenues - other                                      -             23
       Total revenues                                   3,400          3,298
 
     Operating Costs and Expenses
      Cost of products                                    266            148
      Cost of services                                      5             33
      Research and development                          9,984          8,663
      Selling, general and administrative               2,203          1,996
      Carson Street closure                                 -          4,423
       Total operating costs and expenses              12,458         15,263
 
     Loss from operations                             (9,058)       (11,965)
 
     Interest income                                      468            788
     Interest expense                                     (2)            (2)
     Equity in loss of BioMarin/Genzyme LLC           (1,108)          (557)
 
     Net loss                                       $ (9,700)     $ (11,736)
 
     Loss per share, basic and diluted               $ (0.26)       $ (0.34)
 
     Weighted average common shares outstanding,
      basic and diluted                                37,052         35,015
 
 
      Contacts:
      Fredric D. Price
      Chairman and Chief Executive Officer
      BioMarin Pharmaceutical Inc.
      (415) 884-6700
 
      Investor Relations
      (415) 884-6777
 
      Sharon Karlsberg
      Director
      Feinstein Kean Healthcare
     (617) 577-8110
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X37781277
 
 SOURCE  BioMarin Pharmaceutical Inc.