-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, P4a1xipe2o9nKuP+GSCvXQITRVr9ICQFCn4zt8fUh7YWwn/MSUy/EHIX1Y93Gpbi Sz0N1T9N1uVa/OUJdaUQwA== 0001048477-02-000086.txt : 20021101 0001048477-02-000086.hdr.sgml : 20021101 20021101170641 ACCESSION NUMBER: 0001048477-02-000086 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20021031 ITEM INFORMATION: Other events FILED AS OF DATE: 20021101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOMARIN PHARMACEUTICAL INC CENTRAL INDEX KEY: 0001048477 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 680397820 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26727 FILM NUMBER: 02807103 BUSINESS ADDRESS: STREET 1: 371 BEL MARIN KEYS BLVD STREET 2: STE 210 CITY: NOVATO STATE: CA ZIP: 94949 BUSINESS PHONE: 4158846700 MAIL ADDRESS: STREET 1: 371 BEL MARIN KEYS BLVD STREET 2: STE 210 CITY: NOVATO STATE: CA ZIP: 94949 8-K 1 bmrn8k103102.txt PRESS RELEASE Q3 FINANCIALS ================================================================================ SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 31, 2002 BioMarin Pharmaceutical Inc. (Exact name of registrant as specified in its charter) Delaware 000-26727 68-0397820 (State or other jurisdiction of (Commission (IRS Employer incorporation or organization) File Number) Identification No.) 371 Bel Marin Keys Boulevard, Suite 210, Novato, California 94949 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (415) 884-6700 Not Applicable ------------------------------------------------------------- (Former name or former address, if changed since last report) ================================================================================ Item 5. Other Events. On October 31, 2002, BioMarin Pharmaceutical Inc. ( the "Registrant") announced its financial results for the quarter ended September 30, 2002 in a press release, dated October 31, 2002. A copy of the Registrant's press release is attached hereto as Exhibit 99.1. Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits. (a) Financial Statements of Business Acquired. Not Applicable. (b) Pro Forma Financial Information. Not Applicable. (c) Exhibits. Exhibit 99.1 Press Release of the Registrant dated October 31, 2002 related to the announcement of third quarter 2002 financial results. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BioMarin Pharmaceutical Inc., a Delaware corporation Date: November 1, 2002 By: /s/ Fredric D. Price -------------------- Fredric D. Price Chairman and Chief Executive Officer EXHIBIT INDEX Exhibit No. Description Exhibit 99.1 Press Release of the Registrant dated October 31, 2002 related to the announcement of third quarter 2002 financial results. EX-99 3 exhibit991110102.txt Q3 FINANCIALS Exhibit 99.1 Contacts: Joshua Grass Fredda Malkoff Manager, Investor and Financial Relations Account Director BioMarin Pharmaceutical Inc. Feinstein Kean Healthcare (415) 884-6777 (617) 577-8110 jgrass@biomarinpharm.com fmalkoff@fkhealth.com For Immediate Release: BioMarin Announces Third Quarter 2002 Financial Results Conference Call and Webcast to be Held on November 1st at 2:00 PM ET (2000 CET) Novato, CA, October 31, 2002 - BioMarin Pharmaceutical Inc. (Nasdaq and Swiss SWX New Market: BMRN) today announced financial results for its third quarter ended September 30, 2002. The net loss was $17.1 million ($0.32 per share) for the third quarter of 2002 compared to $11.0 million ($0.26 per share) for the third quarter of 2001. The net loss was $58.1 million ($1.10 per share) for the nine months ended September 30, 2002 compared to $32.7 million ($0.83 per share) for the nine months ended September 30, 2001. BioMarin had $86.5 million in cash, cash equivalents and short-term investments as of September 30, 2002. The net loss in the third quarter of 2002 was primarily due to the continued development of the company's lead product programs: AldurazymeTM for MPS I, AryplaseTM for MPS VI, and NeutralaseTM for heparin reversal. Recent Announcements The following recent announcements by BioMarin highlight some of the company's continuing development efforts: o On October 28, 2002, BioMarin and Genzyme announced that the U.S. Food and Drug Administration (FDA) informed the companies that the Aldurazyme (laronidase) Biologics License Application (BLA) had been scheduled for review by the Endocrinologic and Metabolic Drugs Advisory Committee on January 15, 2003. Aldurazyme is an investigational enzyme replacement therapy being developed by BioMarin and Genzyme for patients with mucopolysaccharidosis I (MPS I), a life-threatening genetic disease for which no specific drug treatments currently exist. The companies anticipate a response from the FDA regarding the application to market Aldurazyme in the U.S. by the end of January 2003. o On September 30, 2002, BioMarin announced that it completed critical steps to begin patient enrollment for its Phase 3 trial of Neutralase for reversal of heparin in Coronary Artery Bypass Graft (CABG) surgery. Neutralase is an enzyme that specifically cleaves heparin, a carbohydrate used as an anticoagulant in CABG surgery. Clinical data also suggests that Neutralase may be a valuable heparin reversal agent in angioplasty and may shorten time to patient ambulation. Preclinical experiments indicate that Neutralase may also reverse the newer classes of anticoagulants, such as the Low Molecular Weight Heparins (LMWH) and the pentasaccharide, fondiparinux. o On September 16, 2002, BioMarin announced that the FDA accepted the Aldurazyme BLA and granted the application priority review status. Priority review status specifies that the FDA will respond to the filing within six months from the date of the completed BLA filing, which was July 29, 2002. o On September 12, 2002, BioMarin announced the adoption of a stockholder rights plan. The plan was adopted to better protect BioMarin stockholders and assure they receive full value of their investment in the event of any proposed takeover of the company. The plan was not adopted in response to any specific proposal or attempt to gain control of the company. o On August 22, 2002, BioMarin announced the completion of the acquisition of Glyko Biomedical Ltd. Glyko Biomedical's principal asset was an approximate 21% ownership interest in the capital stock of BioMarin. As a result of the transaction, Glyko Biomedical became an indirect, wholly owned, subsidiary of BioMarin with the number of outstanding shares of BioMarin's common stock remaining the same. BioMarin will host a conference call and webcast to discuss third quarter financial results on November 1, 2002 at 2:00 PM ET (2000 CET). This event can be accessed on the BioMarin website at: http://investor.biomarinpharm.com. Date: November 1st, 2002 Time: 2:00 PM ET (2000 CET) U.S. & Canada Toll-free Dial in #: 1-800-915-4836 International Dial in #: 1-973-317-5319 Replay Toll-free Dial in #: 1-800-428-6051 Replay International Dial in #: 1-973-709-2089 Replay Code #: 265833 BioMarin specializes in the development and commercialization of therapeutic enzyme products to treat serious, life-threatening diseases and other conditions. This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including the following potential future products: Aldurazyme for the treatment of MPS I, Aryplase for the treatment of MPS VI, and Neutralase for the reversal of anticoagulants. 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 and planned clinical trials, actions of regulatory authorities, including actions related to the Biologics License Application for Aldurazyme, 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 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. AldurazymeTM is a trademark of BioMarin/Genzyme LLC. All rights reserved. BioMarin's press releases and other company information are available online at http://www.biomarinpharm.com. Information on BioMarin's website is not incorporated by reference into this press release. BioMarin Pharmaceutical Inc. Consolidated Balance Sheets (in thousands) December 31, September 30, 2001 2002 ------------ ------------- Assets (unaudited) Current assets: Cash and cash equivalents $ 12,528 $ 32,405 Short-term investments 118,569 54,063 Due from BioMarin/Genzyme LLC 3,096 2,332 Current assets of discontinued operations of Glyko, Inc. 668 - Other current assets 1,922 2,570 ------------ ------------- Total current assets 136,783 91,370 Property, plant and equipment, net 32,560 30,994 Investment in BioMarin/Genzyme LLC 1,145 3,750 Other non-current assets 1,323 1,355 ------------ ------------- Total assets $ 171,811 $ 127,469 ============ ============= Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 4,284 $ 763 Accrued liabilities 2,198 5,332 Current liabilities of discontinued operations of Glyko, Inc. 229 5 Other current liabilities 1,591 2,247 ------------ ------------- Total current liabilities 8,302 8,347 Long-term liabilities 3,961 2,912 ------------ ------------- Total liabilities 12,263 11,259 Stockholders' equity: Common stock 52 54 Additional paid-in capital 305,230 318,410 Warrants 5,134 5,219 Deferred compensation (699) (138) Notes receivable from stockholders (2,037) (1,057) Accumulated other comprehensive loss (13) (28) Deficit accumulated during the development stage (148,119) (206,250) ------------ ------------- Total stockholders' equity 159,548 116,210 ------------ ------------- Total liabilities and stockholders' equity $ 171,811 $ 127,469 ============ =============
BioMarin Pharmaceutical Inc. Consolidated Statements of Operations (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, ----------------------- ----------------------- 2001 2002 2001 2002 ---------- ---------- ---------- ---------- Revenue Revenue from BioMarin/Genzyme LLC $ 3,079 $ 3,569 $ 8,621 $ 10,784 Operating expenses Research and development 10,039 14,675 31,042 41,229 General and administrative 2,340 3,940 5,350 10,928 In-process research and development - - - 11,223 ---------- ---------- ---------- ---------- Total operating expenses 12,379 18,615 36,392 63,380 Loss from operations (9,300) (15,046) (27,771) (52,596) Interest income 530 629 1,434 2,033 Interest expense (8) (123) (11) (375) Equity in loss of BioMarin/Genzyme LLC (1,864) (2,350) (4,708) (7,109) ---------- ---------- ---------- ---------- Net loss from continuing operations (10,642) (16,890) (31,056) (58,047) Income (loss) from discontinued operations (373) (219) (1,628) 75 Loss on disposal of discontinued operations - (8) - (159) ---------- ---------- ---------- ---------- Net loss $ (11,015) $ (17,117) $ (32,684) $ (58,131) ========== ========== ========== ========== Net loss per share, basic and diluted Loss from continuing operations $ (0.25) $ (0.32) $ (0.79) $ (1.10) Income (loss) from discontinued operations (0.01) - (0.04) - Loss on disposal of discontinued operations - - - - ---------- ---------- ---------- ---------- Net loss $ (0.26) $ (0.32) $ (0.83) $ (1.10) ========== ========== ========== ========== Weighted average common shares outstanding 42,136 53,446 39,601 53,011 ========== ========== ========== ==========
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