Exhibit 99.1
NEWS
Contacts:
Joshua A. Grass (investors) Francesca DeVellis (media)
Manager, Investor and Financial Relations Vice President
BioMarin Pharmaceutical Inc. Feinstein Kean Healthcare
(415) 884-6777 (617) 761-6703
jgrass@biomarinpharm.com francesca.devellis@fkhealth.com
BioMarin Announces First Quarter 2003 Financial Results
Conference Call and Webcast to be Held Today at 1:00 PM ET (1900 CET)
Novato, CA, May 5th, 2003 - BioMarin Pharmaceutical Inc. (Nasdaq and Swiss SWX
New Market: BMRN) today announced financial results for its first quarter ended
March 31, 2003. The company incurred a loss of $19.7 million ($0.35 per share)
in the first quarter of 2003 compared to a loss of $26.6 million ($0.51 per
share) in the first quarter of 2002. The company received net proceeds of $87.0
million from financing activities in the first quarter of 2003. BioMarin had
$148.6 million in cash, cash equivalents and short-term investments as of March
31, 2003.
Recent Achievements
Fredric D. Price, BioMarin's Chairman and Chief Executive Officer, said "The
recent FDA approval of Aldurazyme represents a critical milestone in the
development of BioMarin as a company. This accomplishment solidifies our place
among an elite group of biotechnology companies that have been able to bring an
important product to market while building a valuable pipeline of additional
product candidates."
o On April 30th, 2003 BioMarin and Genzyme announced that they received
approval from the U.S. Food and Drug Administration to market
Aldurazyme(R) (laronidase), in the United States. As a result, BioMarin
will receive a $12.1 million milestone payment from its joint venture
partner Genzyme Corporation. The companies are also expecting a final
response from the European Union (EU) in the second quarter of 2003.
BioMarin manufactures Aldurazyme in its Novato facility and Genzyme is
responsible for sales and marketing of Aldurazyme to physicians who
treat patients with MPS I.
o On March 31, 2003 BioMarin announced that it completed its Phase 1a
clinical trial of Vibrilase, a topical enzyme product candidate for
serious burns. BioMarin is currently enrolling patients in a Phase 1b
trial, which it expects to complete in the middle of 2003.
o On March 14, 2003 BioMarin announced positive results from its Phase II
open-label study of Aryplase, recombinant human arylsulfatase B, an
investigational enzyme replacement therapy for the treatment of
mucopolysaccharidosis VI (MPS VI). MPS VI (also known as Maroteaux-Lamy
Syndrome) is a debilitating, life-threatening genetic disease, for
which no drug therapies are currently available, that is caused by a
deficiency of the enzyme arylsulfatase B.
o On February 21, 2003 BioMarin and Genzyme announced that the Committee
for Proprietary Medicinal Products (CPMP) of the EU issued a positive
opinion on the companies' marketing application for Aldurazyme. The
positive CPMP opinion is the final step before formal approval to
market Aldurazyme in the 15 countries of the EU. The European
Commission generally follows the advice of the CPMP, but it is not
obliged to do so.
o In the first quarter of 2003 BioMarin announced the completion of a
public offering of 7.5 million shares of common stock to the public at
price of $10.00 per share. BioMarin also announced that the
underwriters of the offering, UBS Warburg LLC, CIBC World Markets Corp.
and SG Cowen Securities Corporation exercised their option to purchase
the entire over-allotment option of 1,125,000 shares of common stock at
$10.00 per share. Separately, BioMarin completed sales of common stock
totaling 500,000 shares at a price of $10.00 per share to Acqua
Wellington North American Fund Equities Ltd. under its existing equity
facility. The gross proceeds from the follow-on offering, the
over-allotment, and the sale of stock through the equity facility
totaled $91.25 million.
BioMarin will host a conference call and webcast to discuss first quarter
financial results today at 1:00 PM ET (1900 CET). This event can be accessed on
the BioMarin website at: http://investor.biomarinpharm.com.
Date: May 5th, 2003
Time: 1:00 PM ET (1900 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 #: 290620
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, without limitation,
statements about: expectations and actions of regulatory authorities, including
the European authorities with respect to Aldurazyme and Vibrilase; the final
results of past clinical trials of Vibrilase; the expected timing, progress,
enrollment and conduct of current and future trials of Vibrilase and the
expected payment from Genzyme. 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 final analysis of results of past clinical trials; results and
timing of current and future clinical trials; enrollment rates of current and
future clinical trials, the content and timing of decisions by the European
Commission and other regulatory authorities concerning Aldurazyme and Vibrilase;
actions by Genzyme; 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 10Q and 8K. 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 is available at
http://www.biomarinpharm.com. Information on BioMarin's website is not
incorporated by reference into this press release.
Aldurazyme is a trademark of BioMarin/Genzyme LLC. All rights reserved
BioMarin Pharmaceutical Inc.
Consolidated Balance Sheets
(In thousands, except share and per share data)
December 31, March 31,
2002 2003
------------------------ ------------------------
------------------------ ------------------------
Assets (unaudited)
Current assets:
Cash and cash equivalents $ 33,638 $ 125,835
Short-term investments 40,340 22,743
Investment in and advances to BioMarin/Genzyme LLC 4,955 5,003
Other current assets 2,139 1,214
------------------------ ------------------------
Total current assets 81,072 154,795
Property and equipment, net 28,206 26,338
Other assets 1,338 1,984
------------------------ ------------------------
Total assets $ 110,616 $ 183,117
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Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 3,930 $ 9,532
Other current liabilities 2,917 3,187
------------------------ ------------------------
Total current liabilities 6,847 12,719
Long-term liabilities 5,226 4,496
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Total liabilities 12,073 17,215
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Stockholders' equity:
Common stock, $0.001 par value: 75,000,000
shares authorized, 53,782,426 and 63,103,286
shares issued and outstanding December 31,
2002 and March 31, 2003, respectively 54 63
Additional paid-in capital 319,038 406,059
Warrants 5,219 5,219
Deferred compensation (47) -
Notes receivable from stockholders (468) (475)
Accumulated other comprehensive income 327 299
Deficit accumulated during the development stage (225,580) (245,263)
------------------------ ------------------------
Total stockholders' equity 98,543 165,902
------------------------ ------------------------
Total liabilities and stockholders' equity $ 110,616 $ 183,117
======================== ========================
BioMarin Pharmaceutical Inc.
Consolidated Statements of Operations
(In thousands, except per share data, unaudited)
Three Months Ended March 31,
------------------------------------------
------------------------------------------
2002 2003
Revenue from BioMarin/Genzyme LLC $ 3,792 $ 3,496
-------------------- ------------------
Operating expenses:
Research and development 13,218 17,758
General and administrative 3,926 3,024
In-process research and development 11,223 -
Loss of BioMarin /Genzyme LLC 2,298 3,257
-------------------- ------------------
Total operating expenses 30,665 24,039
-------------------- ------------------
Loss from operations (26,873) (20,543)
Interest income 380 413
Interest expense (91) (130)
-------------------- --------------------
Net loss from continuing operations (26,584) (20,260)
Income (loss) from discontinued operations 122 -
Gain (loss) on disposal of discontinued operations (141) 577
-------------------- ------------------
-------------------- ------------------
Net loss $ (26,603) $ (19,683)
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Net loss per share, basic and diluted:
Net loss from continuing operations $ (0.51) $ (0.36)
Gain (loss) on disposal of discontinued
operations - 0.01
-------------------- ------------------
Net loss $ (0.51) $ (0.35)
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Weighted average common shares outstanding 52,535 56,964
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