0001048477-01-500052.txt : 20011030 0001048477-01-500052.hdr.sgml : 20011030 ACCESSION NUMBER: 0001048477-01-500052 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20011026 ITEM INFORMATION: Other events FILED AS OF DATE: 20011026 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: 1767364 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 form8k102601.txt -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- 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 26, 2001 (October 26, 2001) BioMarin Pharmaceutical Inc. (Exact name of registrant as specified in its charter) Delaware 000-26727 68-0397820 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 371 Bel Marin Keys Boulevard, 94949 Suite 210 (Zip Code) Novato, California (Address of principal executive offices) (415) 884-6700 (Registrant's telephone number, including area code) -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Item 5. Other Events On October 26, 2001, we announced our financial results for the quarter ended September 30, 2001 in a press release, dated October 26, 2001. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. Item 7. Financial Statements and Exhibits EXHIBIT NO. DESCRIPTION OF DOCUMENT -------------------------------------------------------------------------------- 99.1 Press Release Dated October 26, 2001 related to announcement of third quarter 2001 financial results. SIGNATURES 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. By: /s/ Raymond W. Anderson -------------------------------------------- Raymond W. Anderson Chief Operating Officer, Chief Financial Officer, Secretary and Vice President Finance and Administration Date: October 26, 2001 Exhibit Index EXHIBIT NO. DESCRIPTION OF DOCUMENT -------------------------------------------------------------------------------- 99.1 Press Release Dated October 26, 2001 related to announcement of third quarter 2001 financial results. EX-99 3 pressrelease.txt EXHIBIT 99.1 NEWS Contacts: Jeremy T. Price Sharon Karlsberg Financial and Investor Relations Vice President BioMarin Pharmaceutical Inc. Feinstein Kean Healthcare (415) 884-6777 (617) 577-8110 FOR IMMEDIATE RELEASE BioMarin Announces Third Quarter 2001 Financial Results Novato, CA, October 26th, 2001 - BioMarin Pharmaceutical Inc. (Nasdaq and SWX New Market: BMRN) today announced financial results for its third quarter ended September 30, 2001. Revenues for the third quarter of 2001 were $3.7 million compared to $2.8 million in the third quarter of 2000. The net loss was $11.0 million ($0.26 per share, both basic and diluted) in the third quarter of 2001 compared to $8.1 million ($0.23 per share, both basic and diluted) for the third quarter of 2000. The net loss in the third quarter of 2001 was primarily the result of expenses incurred to advance BioMarin's two lead enzyme replacement therapy clinical programs: AldurazymeTM (recombinant human alpha-L-iduronidase) for MPS I and rhASB (recombinant human arylsulfatase B) for MPS VI. Recent Achievements Fredric D. Price, BioMarin's Chairman and Chief Executive Officer, said, "I am pleased to highlight the following recent corporate and clinical developments:" o On October 10th, we announced the signing of a definitive agreement to acquire NeutralaseTM and Phenylase from IBEX Technologies, Inc (TSE: IBT). Neutralase is an injectable heparinase that reverses the anticoagulation of blood by heparin and other new heparin-like anticoagulants. BioMarin plans to initiate a Phase III trial of Neutralase in Coronary Artery Bypass Graft (CABG) surgery in 2002. Phenylase is an early development stage, orally active enzyme with the potential to treat Phenylketonuria (PKU), a genetic disease caused by an enzyme deficiency that can lead to progressive, severe, and irreversible mental retardation. o In October, we initiated a Phase I study of Vibriolysin Topical for burn debridement (cleaning) in the United Kingdom. o On September 6th, we reported positive results from our Phase I study of rhASB, an investigational enzyme replacement therapy for the treatment of MPS VI. Paul Harmatz, M.D., the study's principal investigator, presented the study data at the American Society of Human Genetics annual meeting in San Diego on October 14th. BioMarin plans to initiate a Phase II trial of rhASB in the first quarter of 2002. o In August, we completed the six-month patient evaluation stage of our Phase III trial of Aldurazyme, an investigational enzyme replacement therapy for the treatment of MPS I. Aldurazyme is being developed in a joint venture with Genzyme General (Nasdaq: GENZ). Mr. Price concluded, "The IBEX product acquisition underscores our dedication to developing novel enzyme therapies for serious conditions and simultaneously broadens our target patient populations beyond those of our ongoing clinical programs. In addition, the Company's two enzyme replacement therapy programs for MPS diseases remain on track, and we look forward to reporting the results of the Aldurazyme Phase III trial in the near future." BioMarin specializes in the development and commercialization of therapeutic enzyme products to treat serious, life-threatening diseases and conditions. Additional information on BioMarin can be found by visiting our corporate website at: http://www.biomarinpharm.com. 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, rhASB for MPS VI, Vibriolysin Topical for burn debridement, Neutralase for the reversal of anticoagulants, and Phenylase for PKU. 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, 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. Aldurazyme is a trademark of BioMarin/Genzyme LLC. All rights reserved. BioMarin Pharmaceutical Inc. Consolidated Balance Sheets (US$ Thousands) September 30 December 31 2001 2000 ----------------------------------------- (unaudited) Assets Current assets: Cash and cash equivalents US$ 7,230 US$ 16,530 Short-term investments 36,675 23,671 Accounts receivable, net 996 1,135 Due from BioMarin/Genzyme LLC 3,855 1,799 Inventories 525 436 Prepaid expenses 1,361 970 ---------------- ---------------- Total current assets 50,642 44,541 Investment in BioMarin/Genzyme LLC 2,164 1,482 Property, plant and equipment, net 27,996 20,715 Note receivable from officer 878 - Goodwill and other intangibles, net 8,314 9,862 Deposits 408 333 ----------------- ---------------- Total assets US$ 90,402 US$ 76,933 ================= ================ Liabilities and Stockholders' Equity Current liabilities: Accounts payable US$ 3,923 US$ 4,747 Accrued liabilities 2,072 2,109 Notes payable - short term 30 27 Current portion of capital lease obligations 65 - ----------------- ---------------- Total current liabilities 6,090 6,883 ================= ================ Long-term liabilities: Long-term portion of notes payable 32 56 Long-term portion of capital lease obligations 114 - ----------------- ---------------- Total long-term liabilities 146 56 Total liabilities 6,236 6,939 Stockholders' equity: Common stock 42 37 Additional paid in capital 195,104 153,940 Common stock warrants 5,134 - Deferred compensation (903) (1,530) Notes from stockholders (2,014) (1,940) Accumulated deficit (113,197) (80,513) ----------------- ---------------- Total stockholders' equity 84,166 69,994 ----------------- ---------------- ----------------- ---------------- Total liabilities and stockholders' equity US$ 90,402 US$ 76,933 ================= ================
BioMarin Pharmaceutical Inc. Consolidated Statements of Operations (US$ Thousands, except per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, -------------------------------- ------------------------------- Revenues 2001 2000 2001 2000 -------------------------------- ------------------------------- Revenues - products US$ 572 US$ 662 US$ 1,760 US$ 1,749 Revenues - services 71 9 245 177 Revenues from BioMarin/Genzyme LLC 3,079 2,136 8,621 7,262 Revenues - other 22 - 182 - -------------------------------- ------------------------------- Total revenues 3,744 2,807 10,808 9,188 Operating Costs and Expenses Cost of products 234 188 719 480 Cost of services 47 6 141 59 Research and development 10,143 8,529 31,842 25,109 Selling, general and administrative 2,993 2,331 7,505 6,517 Carson Street closure - - - 4,423 -------------------------------- ------------------------------- Total operating costs and expenses 13,417 11,054 40,207 36,588 Loss from operations (9,673) (8,247) (29,399) (27,400) Interest income 530 691 1,434 2,281 Interest expense (8) (2) (11) (6) Equity in loss of BioMarin/Genzyme LLC (1,864) (590) (4,708) (1,845) -------------------------------- ------------------------------- Net loss US$ (11,015) US$ (8,148) US$ (32,684) US$ (26,970) ================================ =============================== Loss per share, basic and diluted US$ (0.26) US$ (0.23) US$ (0.83) US$ (0.76) ================================ =============================== Weighted average common shares outstanding, basic and diluted 42,136 36,064 39,601 35,493 ================================ ===============================