-----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, Ilop4aTtFpYhFNRL1HXfX/ySZNWjIewO3spZ0Lug7u1MooDbuT977Vl9JQvESSgU ZKZq/wonAGbv/O18VgPpsA== 0001048477-02-000061.txt : 20020802 0001048477-02-000061.hdr.sgml : 20020802 20020801185238 ACCESSION NUMBER: 0001048477-02-000061 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020731 ITEM INFORMATION: Other events FILED AS OF DATE: 20020802 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: 02717751 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 bmrn8kfinancials.txt PRESS RELEASE: Q2 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): August 1, 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 August 1, 2002, BioMarin Pharmaceutical Inc. (the "Registrant") announced its financial results for the quarter ended June 30, 2002 in a press release, dated August 1, 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 August 1, 2002 related to the announcement of second 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: August 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 August 1, 2002 related to the announcement of second quarter 2002 financial results. EX-99 3 exhibit991080102.txt PRESS RELEASE: Q2 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 Second Quarter 2002 Financial Results Conference Call and Webcast to be Held Today at 4:15 PM ET (2215 CET) Novato, CA, August 1, 2002 - BioMarin Pharmaceutical Inc. (Nasdaq and Swiss SWX New Market: BMRN) today announced financial results for its second quarter ended June 30, 2002. The net loss was $14.4 million ($0.27 per share) for the second quarter of 2002 compared to $12.0 million ($0.30 per share) for the second quarter of 2001. The net loss was $41.0 million ($0.77 per share) for the six months ended June 30, 2002 compared to $21.7 million ($0.57 per share) for the six months ended June 30, 2001. BioMarin had $100.6 million in cash, cash equivalents and short-term investments as of June 30, 2002. The net loss in the second 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 Achievements Fredric D. Price, BioMarin's Chairman and Chief Executive Officer, commented, "Since May, we have made significant progress in our clinical development programs. I am pleased to highlight the following recent achievements and upcoming events:" o BioMarin received a U.S. patent covering AldurazymeTM for the treatment of MPS I. Aldurazyme is a specific form of purified recombinant human alpha-L-iduronidase that is being investigated as an enzyme replacement therapy for MPS I, a life-threatening genetic disease for which no specific drug treatments currently exist. The patent claims unique characteristics of the pharmaceutical composition of Aldurazyme. This patent, which protects a highly purified form of alpha-L-iduronidase, supports the intellectual property position for using Aldurazyme to treat MPS I. o BioMarin and Genzyme submitted the final portion of their "rolling" Biologics License Application (BLA) for Aldurazyme to the U.S. Food and Drug Administration (FDA). The final portion of the BLA includes clinical data from the six-month, placebo-controlled Phase 3 trial of Aldurazyme, six months of data from the ongoing open-label Phase 3 extension study, and three years of data from the Phase 1 trial and extension study. As part of the BLA submission, BioMarin and Genzyme have formally requested Priority Review. o BioMarin appointed a new Chief Financial Officer and elected three new members to its Board of Directors. Louis Drapeau joined BioMarin as Vice President, Finance & Chief Financial Officer, and Secretary. In addition, Franz Cristiani, retired Partner of Arthur Andersen, LLP, Elaine Heron, PhD, Chairman and CEO of Picoliter Inc., and Vijay Samant, President and CEO of Vical Incorporated, were elected to the Board. o BioMarin established a Science Advisory Board (SAB) comprised of leading scientists and physicians who will provide management with critical scientific and strategic input as the Company continues to develop its pipeline of enzyme therapeutics. o The principal investigator from the Phase 1 clinical trial of Aryplase for MPS VI presented positive findings from the trial's extension study that indicate Aryplase continues to be well-tolerated at both dose levels by the five patients who have received treatment for a total of 48 weeks. In addition, the 1.0 mg/kg dose continued to produce a greater sustained reduction than the 0.2 mg/kg dose in the excretion of urinary glycosaminoglycans (GAGs) over 48 weeks. The reduction in urinary GAGs indicates that Aryplase is breaking down the complex carbohydrate materials that otherwise accumulate in patients with MPS VI and lead to the debilitating and life-threatening symptoms of the disease. o Investigators from the Phase 3 clinical trial of Aldurazyme for MPS I presented detailed results from the double-blind portion of the trial and preliminary six-month findings from the trial's ongoing open-label extension study. Data from the extension study indicate patients who received Aldurazyme for twelve months continued to improve upon the results seen in the first six months of treatment. o BioMarin commenced preclinical studies of NeuroTransTM and initiated key steps to continue building the technology's intellectual property position. NeuroTrans is the proprietary brain delivery technology that BioMarin is developing to treat neurological problems associated with many lysosomal storage disorders. Upcoming Events o BioMarin will hold its annual stockholders' meeting on August 13, 2002 at 10:00 a.m. The annual meeting will be held at the Embassy Suites Hotel, located at 101 McInnis Parkway in San Rafael, CA. At this year's annual meeting, BioMarin stockholders will vote on, among other items, the Company's planned acquisition of all the outstanding shares of Glyko Biomedical Ltd. Glyko Biomedical's principal asset is an approximate 21% ownership interest in the capital stock of BioMarin. o BioMarin and Genzyme expect a decision regarding FDA's acceptance of the Aldurazyme BLA and its Priority Review status by the end of September 2002. o BioMarin plans to initiate the first of two Phase 3 clinical trials of NeutralaseTM for the reversal of heparin following Coronary Artery Bypass Graft (CABG) surgery during the third quarter of this year. BioMarin will host a conference call and webcast to discuss second quarter financial results today at 4:15 PM ET (2215 CET). This event can be accessed on the BioMarin website at: http://investor.biomarinpharm.com. Date: August 1st, 2002 Time: 4:15 PM ET (2215 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 #: 973-709-2089 Replay Code #: 254590 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, Neutralase for the reversal of anticoagulants, Aryplase for the treatment of MPS VI, and NeuroTrans for the delivery of enzymes across the blood-brain barrier. 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 and the Marketing Authorization Application, the closing of the planned acquisition of Glyko Biomedical Ltd., 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 Pharmaceutical Inc. Condensed Consolidated Balance Sheets (in thousands) December 31, June 30, 2001 2002 --------------- ------------- (unaudited) Assets Current assets: Cash and cash equivalents $ 12,528 $ 19,363 Short-term investments 118,569 81,195 Due from BioMarin/Genzyme LLC 3,096 2,135 Current assets of discontinued operations of Glyko, Inc. 668 687 Other current assets 1,922 2,175 --------------- ------------- Total current assets 136,783 105,555 Investment in BioMarin/Genzyme LLC 1,145 2,356 Property, plant and equipment, net 32,560 32,704 Other non-current assets 1,323 1,358 --------------- ------------- Total assets $ 171,811 $ 141,973 --------------- ------------- --------------- ------------- Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 4,284 $ 2,014 Accrued liabilities 2,198 3,348 Current liabilities of discontinued operations of Glyko, Inc. 229 158 Other short-term liabilities 1,591 2,211 --------------- ------------- Total current liabilities 8,302 7,731 Long-term liabilities 3,961 3,463 --------------- ------------- Total liabilities 12,263 11,194 --------------- ------------- Stockholders' equity: Common stock 52 53 Additional paid-in capital 305,230 316,813 Common stock warrants 5,134 5,219 Deferred compensation (699) (281) Notes receivable from stockholders (2,037) (2,108) Accumulated other comprehensive income (13) 216 Accumulated deficit (148,119) (189,133) --------------- ------------- Total stockholders' equity 159,548 130,779 --------------- ------------- Total liabilities and stockholders' equity $ 171,811 $ 141,973 --------------- ------------- --------------- -------------
BioMarin Pharmaceutical Inc. Consolidated Statements of Operations (in thousands, except per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, --------------------------- ------------------------- 2001 2002 2001 2002 ------------- ------------- ------------ ------------ Revenues Revenues from BioMarin/Genzyme LLC $ 2,852 $ 3,423 $ 5,542 $ 7,215 Revenues - other 160 - 160 - ------------- ------------- ------------ ------------ Total revenues 3,012 3,423 5,702 7,215 Operating Costs and Expenses Research and development 11,506 13,336 21,163 26,554 General and administrative 1,536 3,062 3,010 6,988 In-process research and development - - - 11,223 ------------- ------------- ------------ ------------ Total operating costs and expenses 13,042 16,398 24,173 44,765 Loss from operations (10,030) (12,975) (18,471) (37,550) Interest income 436 1,024 904 1,404 Interest expense (1) (161) (3) (252) Equity in loss of BioMarin/Genzyme LLC (1,736) (2,461) (2,844) (4,759) ------------- ------------- ------------ ----------- Net loss from continuing operations (11,331) (14,573) (20,414) (41,157) Income (loss) from discontinued operations (638) 172 (1,255) 294 Loss from disposal of discontinued operations - (10) - (151) ------------- ------------- ------------ ----------- Net loss $ (11,969) $ (14,411) $ (21,669) $(41,014) ------------- ------------- ------------ ----------- ------------- ------------- ------------ ----------- Net loss per share, basic and diluted Loss from continuing operations $ (0.28) $ (0.27) $ (0.54) $ (0.78) ------------- ------------- ------------ ----------- Income (loss) from discontinued operations $ (0.02) $ - $ (0.03) $ 0.01 ------------- ------------- ------------ ----------- Loss on disposal of discontinued operations $ - $ - $ - $ - ------------- ------------- ------------ ----------- Net loss $ (0.30) $ (0.27) $ (0.57) $ (0.77) ------------- ------------- ------------ ----------- Weighted average common shares outstanding 39,587 53,407 38,313 52,973 ------------- ------------- ------------ -----------
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