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
========== ========== ========== ==========