-----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, Di7ftk9uRRUITb6yLsQ8QMGZwq71VOXoPPq0brPx6WbcmwzDmxVOMkGznhmSv6h8 V6ngUEuUTqVeEKQWHgj6+A== 0001048477-03-000072.txt : 20030923 0001048477-03-000072.hdr.sgml : 20030923 20030922215302 ACCESSION NUMBER: 0001048477-03-000072 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030922 ITEM INFORMATION: Other events FILED AS OF DATE: 20030923 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: 03905084 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 form8k.txt FORM 8-K =============================================================================== 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): September 22, 2003 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 September 22, 2003, BioMarin Pharmaceutical Inc. (the "Company"), issued a press release announcing the termination of it Phase 3a study of Neutralase and the termination of the Neutralase program for all indications. The Company's press release issued on September 22, 2003 is attached hereto as Exhibit 99.1. The press release included an estimate of "cash burn" (a non-GAAP financial measure) for the years ending December 31, 2003 and 2004. The Company estimates that cash burn for 2003 and 2004 will be between $74-78 million and $69-73 million, respectively. The Company defines cash burn as net cash flow for a fiscal year (determined in accordance with generally accepted accounting principles) less all proceeds from capital markets financing activities. The Company estimates total net increase in cash for the year ending December 31, 2003 to be approximately $131 million to $135 million and the aggregate net proceeds from its public offering of common stock, sales of common stock to an institutional investor and convertible debt offering to be approximately $209 million. The Company does not anticipate any additional capital market financing activities in 2004 or for the remainder of 2003. Therefore, the estimated cash burn for 2004 is equal to the estimated total net decrease in cash for 2004. The Company believes that cash burn, although a non-GAAP financial measure, provides useful information to investors by showing the net cash expended in most aspects of its activities. The Company also believes that the presentation of this non-GAAP financial measure is consistent with the Company's past practice, as well as industry practice in general, and will enable investors and analysts to compare current non-GAAP measures with non-GAAP measures presented in prior periods. Any non-GAAP financial measure used by the Company should not be considered in isolation or as a substitute for measures of performance prepared in accordance with GAAP. 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 Company dated September 22, 2003. 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: September 22, 2003 By: /s/ Louis Drapeau ----------------- Louis Drapeau Chief Financial Officer EXHIBIT INDEX Exhibit No. Description Exhibit 99.1 Press Release of the Company dated September 22, 2003. EX-99 3 pressrelease.txt EXHIBIT 99.1 Exhibit 99.1 Contacts: Joshua A. Grass Susan Ferris Manager, Investor Relations Manager, Corporate Communications BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. (415) 506-6777 (415) 506-6701 For Immediate Release: BioMarin Halts Phase 3a Study of Neutralase in CABG and Terminates the Neutralase Drug Development Program BioMarin Spending Projected to Decrease in Both 2003 and 2004 Conference Call at 9:00 AM ET (15:00 CET) Novato, CA, September 22, 2003 - BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced that it halted its Phase 3a study of NeutralaseTM for the reversal of anticoagulation by heparin in primary Coronary Artery Bypass Graft (CABG) surgery and that it has terminated its Neutralase program for all indications. The decision to halt the Phase 3 study resulted from a recommendation from an independent Data Safety Monitoring Board (DSMB) and was based on a review of data from enrolled patients, which indicated with high probability that Neutralase would not demonstrate favorable safety and efficacy. Given the expected risk/benefit profile for Neutralase, BioMarin has decided to stop development of the drug for all indications. As a result of the planned reductions in spending related to the discontinuation of Neutralase development, BioMarin has lowered its projected net loss by $5 million for 2003 and by $13 million for 2004. Revised estimates for both net loss and cash burn for 2003 and 2004 are included below, as are previous forecasts for purposes of comparability: Changes to 2003 and 2004 Forecast ($ in millions) 2003 2004 ---- ---- Forecast Current Previous Current Previous Net Loss $76-$78 $81-$83 $68-$70 $81-$83 Cash Burn $74-$78 $80-$84 $69-$73 $80-$84 As of June 30, 2003, BioMarin had approximately $265 million in cash and cash equivalents. - More - Fredric D. Price, Chairman and Chief Executive Officer of BioMarin stated, "While we are disappointed that Neutralase will not become a successful product, it is better to have learned this relatively early in its development at BioMarin. We have planned BioMarin's product portfolio carefully, and have adequate resources for our other promising product opportunities, including AryplaseTM, which is in a pivotal Phase 3 trial." BioMarin's portfolio includes product candidates for genetic diseases, including Aryplase for mucopolysaccharidosis VI that is in a Phase 3 clinical trial expected to be completed at the end of the first quarter of 2004, and a product candidate for Phenylketonuria (PKU) that the company expects to advance into clinical-stage development in 2004. VibrilaseTM, an enzyme product candidate for treatment of serious burns, is nearing completion of a Phase 1b study, and NeuroTransTM is in preclinical testing as a method to deliver both enzymes and other therapeutic molecules to the brain via traditional intravenous infusion. Aldurazyme(R) for mucopolysaccharidosis I is approved in both the United States and European Union. Aldurazyme is manufactured by BioMarin and is marketed by BioMarin's joint venture partner, Genzyme Corporation. BioMarin will host a conference call and webcast to discuss the decision to terminate Neutralase development today at 9:00 AM ET (15:00 CET). This event can be accessed on the BioMarin website at: http://investor.biomarinpharm.com. Date: September 22, 2003 Time: 9:00 AM ET (15:00 CET) U.S. & Canada Toll-free Dial-in #: 1-888-391-0090 International Dial-in #: 415-537-1988 Replay Toll-free Dial-in #:1-800-633-8625 Replay International Dial-in #: 402-977-9141 Replay Code #: 21161394 BioMarin develops and commercializes therapeutic enzyme products to treat serious, life-threatening diseases and conditions. BioMarin defines cash burn as net cash flow for a fiscal year (determined in accordance with generally accepted accounting principles) less all proceeds from capital markets financing activities. BioMarin's proceeds from all capital markets financing activities in its fiscal year 2003 through the date of this release are $209.4 million. Forward-Looking Statement This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the net loss and cash burn of BioMarin for fiscal years 2003 and 2004, the cessation of clinical trials of Neutralase and the cessation of the development program for Neutralase for all indications, resources for product candidates, results of clinical trials of Aryplase as well as trials for a product for PKU and for Vibrilase, and expected timing and progress of current and future trials. 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: the actual results of - More - operations of BioMarin for its fiscal years 2003 and 2004, including without limitation actual revenues and expenses and cash flows; the final analysis of results of past clinical trials; results and timing of current and future clinical trials; the content and timing of decisions by regulatory authorities; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Factors That May Affect Future Results" in BioMarin's 2002 Annual Report on Form 10-K and the factors contained in BioMarin's reports on Forms 10-Q and 8-K. 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's press releases and other company information are available online at http://www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release. # # # -----END PRIVACY-ENHANCED MESSAGE-----