Innovative therapeutics

Investors

BioMarin Announces Third Quarter 2008 Financial Results
Well-Positioned for Continued Long-Term Growth
Conference Call and Webcast to Be Held Today at 5:00 p.m. ET (22:00 CET)
Oct 28, 2008
PRNewswire-FirstCall
NOVATO, Calif.
  Financial Highlights ($ in millions, except per share data)

  Item                    Q3 2008                Q3 2007 Comparison
  Total BioMarin Revenue  $72.6                  190.5% increase
  Naglazyme Net
   Product Revenue        $33.3                  56.3% increase
  Aldurazyme Net Sales
   by Genzyme             $38.2                  18.3% increase
  Aldurazyme BioMarin
   Net Product Revenue    $20.7                  NA
  Kuvan Net Product
   Revenue                $13.8                  NA
  GAAP Net Income (Loss)  $0.8, $0.01 per share  ($5.2), ($0.05) per share
  Non-GAAP Net Income
   (Loss)                 $8.2, $0.08 per share  ($0.2), ($0.00) per share

   2008 Guidance Unchanged ($ in millions)

  Item                                          Guidance
  Total BioMarin Revenues*                      $288 to $326
  Total Net Product Revenues                    $247 to $285
  Naglazyme Net Product Revenue                 $130 to $140
  Aldurazyme Net Product Sales by Genzyme       $135 to $145
  Aldurazyme Net Product Revenue to BioMarin    $72 to $80
  Kuvan Net Product Revenue                     $45 to $65
  Net Income (GAAP)*                            $30 to $42
  Net Income (non-GAAP)*                        $54 to $69

*Assumes that the $30 million milestone for EU Kuvan approval will be earned in 2008

BioMarin Pharmaceutical Inc. today announced financial results for the third quarter ended September 30, 2008. Net income was $0.8 million ($0.01 per share) for the third quarter of 2008, compared to a net loss of $5.2 million ($0.05 per share) for the third quarter of 2007. Non- GAAP net income was $8.2 million ($0.08 per share) for the third quarter of 2008, compared to non-GAAP net loss of $0.2 million ($0.00 per share) for the third quarter of 2007. Non-GAAP net income/loss excludes non-cash stock compensation expense, which was $7.4 million for the three months ended September 30, 2008, compared to $5.0 million for the three months ended September 30, 2007. Net income for the nine months ended September 30, 2008 was $6.3 million ($0.06 per share), compared to a net loss of $18.4 million ($0.19 per share) for the nine months ended September 30, 2007. Non-GAAP net income was $24.1 million ($0.24 per share) for the nine months ended September 30, 2008, compared to non-GAAP net loss of $5.6 million ($0.06 per share) for the nine months ended September 30, 2007. Basic and diluted GAAP and non-GAAP earnings per share for the three and nine months ended September 30, 2008 were the same, except for non-GAAP diluted earnings per share for the nine months ended September 30, 2008, which was $0.23 per share. Non-cash stock compensation expense for the nine months ended September 30, 2008 and September 30, 2007 was $17.8 million and $12.8 million, respectively.

As of September 30, 2008, BioMarin had cash, cash equivalents, and short-term investments totaling $563.0 million.

"Our three growing commercial products contributed to healthy revenue growth during the third quarter of 2008 as compared to the third quarter of 2007. The international market for Naglazyme continues to expand at rates beyond our original expectations, with the largest increase in the absolute patient numbers in two years. The decline in sequential revenue resulted from ordering patterns from some customers outside the United States, and we still see tremendous potential in this product," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin.

Mr. Bienaime continued, "As of October 24, 208 patients have been referred through the Kuvan free drug program, including patients in the pilot program. We are supporting a number of investigator-sponsored trials to generate additional data to support the use of Kuvan, as well as various patient communication and online efforts. Also, our partner Merck Serono received a positive CHMP opinion for Kuvan in late September which bodes well for potential approval by the end of the year. We are well on our way to achieving our first fully profitable year with a strong cash position and a full development pipeline. Going forward, we remain focused on the Kuvan launch, the continued geographic expansion of Naglazyme, and the timely development of the PEG-PAL, GALNS for MPS IVA and other promising pipeline programs."

Net Product Revenue

Net product revenue from Naglazyme (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), was $33.3 million for the third quarter of 2008, an increase of 56.3 percent compared to Naglazyme net product revenue of $21.3 million for the third quarter of 2007. Net product revenue from Naglazyme for the nine months ended September 30, 2008 was $96.2 million, an increase of 58.7 percent from Naglazyme net product revenue of $60.6 million for the nine months ended September 30, 2007. BioMarin is directly commercializing Naglazyme in the United States, Western Europe, Brazil, and Turkey and through distributors in other international markets.

Net sales of Aldurazyme (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I (MPS I) recorded by Genzyme, were $38.2 million for the third quarter of 2008, an increase of 18.3 percent compared to net sales by Genzyme of $32.3 million for the third quarter of 2007. Net sales of Aldurazyme recorded by Genzyme for the nine months ended September 30, 2008 were $113.7 million, an increase of 28.8 percent compared to net sales by Genzyme of $88.3 million for the nine months ended September 30, 2007.

Net product revenue to BioMarin related to Aldurazyme was $20.7 million for the third quarter of 2008. This reflects an increase in net product revenue from the amounts payable to BioMarin by Genzyme due to incremental product transfer revenue as transfers of product to Genzyme exceeded the amount of product shipped to third party customers by Genzyme during the third quarter of 2008. Net product revenue to BioMarin related to Aldurazyme was $58.1 million for the nine months ended September 30, 2008.

Beginning January 1, 2008, as a result of the restructuring of the joint venture with Genzyme, BioMarin receives a royalty of 39.5% to 50% of worldwide net sales. BioMarin recognizes a portion of this amount as product transfer revenue when product is released to Genzyme. This amount will eventually be credited against the calculated royalties earned when the product is sold by Genzyme to third parties.

Net product revenue from Kuvan (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), was $13.8 million for the third quarter of 2008 and $31.6 million for the nine months ended September 30, 2008.

Collaborative Agreement Revenues

Collaborative agreement revenues for the third quarter of 2008 were $2.4 million, compared to $3.1 million for the third quarter of 2007. Collaborative agreement revenues for the nine months ended September 30, 2008 were $7.4 million, compared to $10.8 million for the nine months ended September 30, 2007. Collaborative agreement revenues decreased in 2008 compared to 2007 due to less reimbursable Kuvan development expenses during the third quarter and first nine months of 2008.

2008 Financial Guidance Maintained

BioMarin estimates 2008 net sales of Naglazyme will be in the range of $130 million to $140 million.

Net sales of Aldurazyme by Genzyme are estimated to be in the range of $135 million to $145 million. BioMarin's net product revenue related to Aldurazyme is estimated to be between $72 million and $80 million, which includes both the royalty earned on net sales by Genzyme and incremental product revenue related to the transfer of Aldurazyme inventory to Genzyme to meet future product demand.

BioMarin estimates 2008 Kuvan net sales to be in the range of $45 million to $65 million.

BioMarin estimates its Generally Accepted Accounting Principles (GAAP) net income for the fiscal year ending December 31, 2008 will be in the range of $30 million to $42 million, which assumes that the $30 million milestone for EU Kuvan approval will be earned in 2008. The net income estimate includes approximately $24 million to $27 million in non-cash stock compensation expense. Non-GAAP net income, excluding the impact of non-cash stock compensation expense, is estimated to be in the range of $54 million to $69 million.

Non-GAAP Financial Information and Reconciliation

The above results for the third quarter and first nine months of 2007 and 2008 and financial guidance for 2008 include actual and Management's 2008 estimated net income, respectively, determined in accordance with GAAP and non-GAAP net income. As used in this release, non-GAAP income is net income calculated in accordance with GAAP, but excluding non-cash stock compensation expense, a non-GAAP financial measure. Stock compensation expense excluded in the calculation of non-GAAP net income was $7.4 million for the third quarter of 2008, $5.0 million for the third quarter of 2007, $17.8 million for the nine months ended September 30, 2008, $12.8 million for the nine months ended September 30, 2007 and $24.0 million to $27.0 million for Management's estimate of 2008 net income. The reconciliation of this measure to the estimated GAAP net income is as follows (in millions):

                                        Nine       Nine
                                       months     months
                                        ended      ended
                                      September  September      2008
                    Q3       Q3          30,        30,      Management
                   2008     2007        2008       2007       Guidance
  GAAP net
   income (loss)   $0.8     $(5.2)      $6.3     $(18.4)   $30.0 - $42.0
  Non-cash
   stock
   compensation
   expense          7.4       5.0       17.8       12.8      24.0 - 27.0
  Non-GAAP net
   income (loss)   $8.2     ($0.2)     $24.1      $(5.6)   $54.0 - $69.0



Management believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin's GAAP information because Management uses such information internally for its operating, budgeting and financial planning purposes, and to enhance investors' overall understanding of the company's prospects for the future.

  Anticipated Upcoming Milestones

  -- 4Q08: Kuvan approval by EMEA and related $30 million milestone from
     Merck Serono
  -- 1Q09: Results from Phase 2 PAD trial
  -- 1Q09: Results from BH4+Vitamin C study
  -- 1Q09: Results from Phase 2 PAH trial
  -- 1Q09: Results from proteinuria in chronic kidney disease trial
  -- 1Q09: Initiation of Phase 1 trial for GALNS for MPS IVA
  -- 1Q09/2Q09: Results from PEG-PAL Phase 1 trial
  -- 1Q09/2Q09: Initiation of PEG-PAL Phase 2 trial


  Upcoming Investor Conferences and Events

  -- November 11-14: Credit Suisse Healthcare Conference
  -- December 2-3: Piper Jaffray Healthcare Conference


BioMarin will host a conference call and webcast to discuss third quarter 2008 financial results today, Tuesday, October 28, at 5:00 p.m. ET (22:00 CET). This event can be accessed on the investor section of the BioMarin website at http://www.bmrn.com/.

   Date: October 28, 2008
   Time: 5:00 p.m. ET (22:00 CET)
   U.S. / Canada Dial-in Number:  800.299.9630
   International Dial-in Number:  617.786.2904
   Participant Code: 70952576
   Replay Dial-in Number: 888.286.8010
   Replay International Dial-in Number: 617.801.6888
   Replay Code: 67493262


  About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises three approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of peripheral arterial disease and sickle cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase 1 clinical development for the treatment of PKU. For additional information, please visit http://www.bmrn.com/. Information on BioMarin's website is not incorporated by reference into this press release.

Forward-Looking Statement

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the expectations of revenue and sales related to Naglazyme, Kuvan, and Aldurazyme; the financial performance of the BioMarin as a whole; the timing of BioMarin's clinical trials of 6R-BH4 for other indications, PEG- PAL and other product candidates; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, and its product candidates; and actions by regulatory authorities. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: our success in the continued commercialization of Naglazyme and Kuvan; Genzyme Corporation's success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical trials; our ability to successfully manufacture our products and product candidates; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products and particularly Aldurazyme, Naglazyme and Kuvan; actual sales of Aldurazyme, Naglazyme and Kuvan; Merck Serono's activities related to Kuvan; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2007 Annual Report on Form 10-K, and the factors contained in BioMarin's reports on Form 10-Q. Stockholders are urged not to place undue 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.

BioMarin(R) , Naglazyme(R) and Kuvan(R) are a registered trademarks of BioMarin Pharmaceutical Inc.

  Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.

   Contact:

   Investors                       Media
   Eugenia Shen                    Susan Berg
   BioMarin Pharmaceutical Inc.    BioMarin Pharmaceutical Inc.
   (415) 506-6570                 (415) 506-6594



              BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES

                       CONSOLIDATED BALANCE SHEETS
           (In thousands, except for share and per share data)

                                                December 31,   September 30,
                                                  2007 (1)         2008
                                                                (unaudited)
                            ASSETS
  Current assets:
    Cash and cash equivalents                     $228,343       $271,217
    Short-term investments                         357,251        291,752
    Accounts receivable, net                        16,976         51,135
    Advances to BioMarin/Genzyme LLC                 2,087            206
    Inventory                                       32,445         68,094
    Other current assets                             7,195         14,609

      Total current assets                         644,297        697,013

    Investment in BioMarin/Genzyme LLC              44,881            343
    Other investments                                    -          4,659
    Property, plant and equipment, net              76,818        110,716
    Intangible assets, net                           9,596          6,068
    Goodwill                                        21,262         21,262
    Restricted cash                                  2,889          6,219
    Other assets                                    15,536         12,758


      Total assets                                $815,279       $859,038


           LIABILITIES AND STOCKHOLDERS' EQUITY
  Current liabilities:
    Accounts payable and accrued liabilities       $49,907        $47,982
    Current portion of acquisition obligation,
     net of discount                                 6,309         71,158
    Deferred revenue                                 5,327          1,443
    Other current liabilities                            -            152

      Total current liabilities                     61,543        120,735
  Convertible debt                                 497,375        497,240
  Long-term portion of acquisition obligation,
   net of discount                                  66,553              -
  Other long-term liabilities                        2,082          3,162

      Total liabilities                            627,553        621,137

  Stockholders' equity:
    Common stock, $0.001 par value: 250,000,000
     shares authorized at December 31, 2007 and
     September 30, 2008; 97,114,159 and 99,691,581
     shares issued and outstanding at December 31,
     2007 and September 30, 2008, respectively          97            100
    Additional paid-in capital                     794,917        841,657
    Company common stock held by deferred
     compensation plan                                   -           (939)
    Accumulated other comprehensive income (loss)      139         (1,818)
    Accumulated deficit                           (607,427)      (601,102)

      Total stockholders' equity                   187,726        237,901

      Total liabilities and stockholders' equity  $815,279       $859,038

  (1) December 31, 2007 balances were derived from the audited consolidated
      financials.



              BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES

                  CONSOLIDATED STATEMENTS OF OPERATIONS
     For the Three and Nine Months Ended September 30, 2007 and 2008
           (In thousands, except for per share data, unaudited)

                          Three Months Ended          Nine Months Ended
                             September 30,              September 30,
                           2007         2008          2007        2008

  Revenues:
    Net product revenues $21,325      $67,812      $60,600     $185,895
    Collaborative
     agreement revenues    3,107        2,414       10,758        7,389
    Royalty and license
     revenues                574        2,420        5,369        3,933

      Total revenues      25,006       72,646       76,727      197,217

  Operating expenses:
    Cost of sales          4,460       14,063       13,135       40,844
    Research and
     development          17,241       26,175       54,585       67,559
    Selling, general and
     administrative       19,521       28,964       53,075       77,836
    Amortization of
     acquired intangible
     assets                1,093        1,093        3,278        3,278

      Total operating
       expenses           42,315       70,295      124,073      189,517

  Income (loss) from
   operations            (17,309)       2,351      (47,346)       7,700
  Equity in the income
   (loss) of
   BioMarin/Genzyme LLC    8,446         (572)      21,159       (1,692)
  Interest income          7,948        3,407       18,549       13,157
  Interest expense        (4,109)      (4,105)     (10,163)     (12,297)
  Income (loss) before
   income taxes           (5,024)       1,081      (17,801)       6,868
  Provision for income
   taxes                     192          252          572          543

    Net income (loss)    $(5,216)        $829     $(18,373)      $6,325

    Net income (loss)
     per share, basic     $(0.05)       $0.01       $(0.19)       $0.06

    Net income (loss)
     per share, diluted   $(0.05)       $0.01       $(0.19)       $0.06

  Weighted average
   common shares
   outstanding, basic     96,199       99,537       95,523       98,705

  Weighted average
   common shares
   outstanding, diluted   96,199      103,403       95,523      103,916

  (1) The following is the stock-based compensation expense included in the
      respective captions of the condensed consolidated statements of
      operations above:



                           Three Months Ended         Nine Months Ended
                              September 30,             September 30,
                           2007          2008         2007         2008

    Cost of sales           $136         $430         $416       $1,019
    Selling, general
     and administrative
     expense               3,001        4,468        7,635       10,674
    Research and
     development           1,864        2,501        4,767        6,118

  Total stock-based
   compensation expense   $5,001       $7,399      $12,818      $17,811

FCMN Contact: eshen@bmrn.com

SOURCE: BioMarin Pharmaceutical Inc.

CONTACT: investors, Eugenia Shen, +1-415-506-6570, media, Susan Berg,
+1-415-506-6594, both of BioMarin Pharmaceutical Inc.
/First Call Analyst:


BioMarin

Diseases

Lysosomal Storage Disorders (MPS I, MPS IVA, MPS VI, CLN2 disease) PKU

Products

Palynziq®
Brineura®
Vimizim®
Kuvan®
Naglazyme®
Aldurazyme®

Patient/Physician Support Contact Information

BioMarin RareConnections
Tel: 866.906.6100
Fax: 888.863.3361
E-mail: support@biomarin-rareconnections.com

Global Medical Information

Contact Global Medical Information