Exhibit 99.1
NEWS
Contacts:
Jeremy T. Price Sharon Karlsberg
Manager, Investor Relations Vice President
BioMarin Pharmaceutical Inc. Feinstein Kean Healthcare
(415) 884-6777 (617) 577-8110
jprice@biomarinpharm.com skarlsberg@fkhealth.com
For Immediate Release:
BioMarin Announces First Quarter 2002 Financial Results
Conference Call and Webcast to be Held Today at 4:15 PM ET (2215 CET)
Novato, CA, May 7th, 2002 - BioMarin Pharmaceutical Inc. (Nasdaq and Swiss SWX
New Market: BMRN) today announced financial results for its first quarter ended
March 31, 2002. The net loss was $26.6 million ($0.51 per share) in the first
quarter of 2002 compared to $9.7 million ($0.26 per share) for the first quarter
of 2001. BioMarin had $114.8 million in cash, cash equivalents and short-term
investments as of March 31, 2002.
The net loss in the first quarter of 2002 was primarily due to the continued
advancement of the Company's lead product development programs as well as a
non-routine charge of approximately $11.2 million as an in-process research and
development expense for the costs related to the acquisition of Synapse
Technologies Inc. This amount includes the purchase price (a non-cash charge of
$10.2 million) and the expenses associated with the transaction ($1.0 million).
Recent Achievements
Fredric D. Price, BioMarin's Chairman and Chief Executive Officer, commented,
"During the first four months of 2002, we made significant progress in all of
our clinical development programs. I am pleased to highlight the following
recent achievements and upcoming events:"
o On April 12, BioMarin and Genzyme filed the first portion of a
`rolling' Biologics License Application (BLA) with the U.S. Food and
Drug Administration (FDA) for approval to market Aldurazyme(TM).
Aldurazyme is an investigational enzyme replacement therapy for
patients with mucopolysaccharidosis I (MPS I), a life-threatening
genetic disease.
o On March 29, BioMarin began dosing patients in a Phase 2 clinical trial
of Aryplase(TM), an investigational enzyme replacement therapy for the
treatment of MPS VI, another life-threatening genetic disease.
o On March 21, BioMarin acquired Synapse Technologies Inc. for a purchase
price of approximately $10.2 million payable in 885,240 shares of its
common stock. BioMarin may also be required to make future contingent
payments in either cash or BioMarin stock of up to approximately $6.0
million.
o On March 1, BioMarin and Genzyme submitted a Marketing Authorization
Application (MAA) to the European Agency for the Evaluation of
Medicinal Products (EMEA) for approval to market Aldurazyme in the
European Union. The Agency has accepted the MAA and validated that it
is complete and ready for scientific review.
o On February 25, BioMarin announced that the Company's catalog business
(Glyko, Inc.) is being discontinued, and certain operating assets may
be offered for sale. Consequently, the financial results of Glyko are
being accounted for as a discontinued business. As a result, all of
BioMarin's resources are now focused exclusively on the development of
its novel therapeutic programs.
Upcoming Events
o BioMarin and Glyko Biomedical Ltd. (a separate entity and unrelated
to Glyko, Inc.) will vote at their respective annual shareholder
meetings on BioMarin's planned acquisition of all the outstanding
shares of Glyko Biomedical Ltd. Glyko Biomedical's principal asset
is a 21% ownership interest in the capital stock of BioMarin. While
both annual meetings were originally scheduled to be held by the end
of May, the need for postponement has arisen following notice that,
as part of its routine procedures, the United States Securities and
Exchange Commission (SEC) has selected for review the joint proxy
circular prepared by BioMarin and Glyko Biomedical. The joint proxy
circular will ultimately be delivered to shareholders of both
companies in connection with meetings to be held to approve the
transaction. Although implementation will be delayed, the companies
remain committed to completing the transaction in accordance
with the terms of the definitive agreement for the transaction
executed by the parties. BioMarin and Glyko Biomedical will provide
guidance as to the new annual meeting dates as soon as possible.
o During the 7th International Symposium on Mucopolysaccharide and
Related Diseases and 3rd Scientific Lysosomal Storage Disorders
Congress from June 20 to June 23 in Paris, investigators will present
detailed results from the six-month, double-blind, placebo-controlled
Phase 3 clinical trial of Aldurazyme.
o In the third quarter of this year, BioMarin and Genzyme plan to
complete the Aldurazyme `rolling' BLA filing. The BLA will include six
months of data from the ongoing open-label Phase 3 extension study in
addition to the six-month data from the placebo-controlled portion of
the Phase 3 trial. Following discussions with the FDA, BioMarin and
Genzyme believe that including longer-term clinical results from the
extension study will provide additional evidence in support of
Aldurazyme's approval in the United States. BioMarin and Genzyme
anticipate responses from the FDA and the EMEA regarding the
applications to market Aldurazyme in the United States and Europe
during the first half of 2003.
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 second half of this year.
BioMarin will host a conference call and webcast to discuss first 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: May 7th, 2002
Time: 4:15 PM ET (2215 CET)
U.S. & Canada Toll-free Dial in #: 1-888-224-3260
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 #: 241367
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, and Aryplase for the treatment of MPS VI. 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.
Aldurazyme is a trademark of BioMarin/Genzyme LLC. All rights reserved.
BioMarin Pharmaceutical Inc.
Consolidated Balance Sheets
($ Thousands)
March 31, December 31,
2002 2001
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Assets (unaudited)
Current assets:
Cash and cash equivalents $ 18,202 $ 12,528
Short-term investments 96,596 118,569
Due from BioMarin/Genzyme LLC 5,888 3,096
Current assets of discontinued operations of Glyko, Inc. 852 668
Note receivable from officer 301 -
Other current assets 1,587 1,922
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Total current assets 123,426 136,783
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Property, plant and equipment, net 33,059 32,560
Investment in BioMarin/Genzyme LLC (512) 1,145
Note receivable from officer 899 889
Deposits 434 434
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Total assets $ 157,306 $ 171,811
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Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 3,188 $ 4,284
Accrued liabilities 4,375 2,198
Current liabilities of discontinued ops. of Glyko, Inc. 154 229
Current portion of capital lease obligations 193 66
Short-term portion of notes payable 1,525 1,525
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Total current liabilities 9,435 8,302
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Long-term portion of notes payable 3,421 3,864
Long-term portion of capital lease obligations 82 97
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Total liabilities 12,938 12,263
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Stockholders' equity:
Common stock 52 52
Additional paid in capital 316,470 305,230
Warrants 5,219 5,134
Deferred compensation (490) (699)
Notes receivable from stockholders (2,087) (2,037)
Foreign currency translation adjustment (74) (13)
Deficit accumulated during development stage (174,722) (148,119)
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Total stockholders' equity 144,368 159,548
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Total liabilities and stockholders' equity $ 157,306 $ 171,811
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BioMarin Pharmaceutical Inc. and Subsidiaries
Consolidated Statements of Operations
($ Thousands, except per share data)
Three Months Ended March 31,
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2002 2001
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(unaudited)
Revenues:
BioMarin/Genzyme LLC $ 3,792 $ 2,691
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Total revenues 3,792 2,691
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Operating Costs and Expenses:
Research and development 13,218 9,149
General and administrative 3,926 1,965
In-process research and development 11,223 -
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Total operating costs and expenses 28,367 11,114
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Loss from operations (24,575) (8,423)
Interest income 380 454
Interest expense (91) (2)
Equity in loss from BioMarin/Genzyme LLC (2,298) (1,108)
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Net loss from continuing operations (26,584) (9,079)
Income (Loss) from discontinued operations 122 (617)
Loss from disposal of discontinued operations (141) -
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Net loss $ (26,603) $ (9,696)
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Net loss per share, basic and diluted:
Loss from continuing operations
$ (0.51) $ (0.24)
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Income (Loss) from discontinued operations
$ (0.00) $ (0.02)
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Loss on disposal of discontinued operations
$ (0.00) $ (0.00)
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Net loss
$ (0.51) $ (0.26)
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Weighted average common shares outstanding 52,535 37,052
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