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BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) today announced financial results for the third quarter of the fiscal year 2004. The company incurred a net loss of $29.5 million ($0.46 per share) for the third quarter ended September 30, 2004 compared to $21.3 million ($0.33 per share) for the third quarter ended September 30, 2003. The net loss was $105.0 million ($1.63 per share) for the nine months ended September 30, 2004 compared to $50.1 million ($0.81 per share) for the nine months ended September 30, 2003.
BioMarin's net loss for the quarter ended September 30, 2004 included $3.8 million in non-cash charges related to the acquisition of the Ascent Pediatrics business. The non-cash charges related to the acquisition for the nine months ended September 30, 2004 were $41.4 million.
Louis Drapeau, Acting Chief Executive Officer of BioMarin commented, "The Board of Directors and senior management team have set specific goals for improving our financial position and strengthening our business without slowing the progress of our key product development programs. First, we are intensely focused on product outlicensing activities designed to bolster our cash position and reduce our development expenses while retaining the rights to market our products in the United States. Secondly, we are initiating strategic marketing campaigns for Orapred(R) in anticipation of new generic competition. Lastly, we have implemented company-wide cost reduction strategies that will reduce expenses in 2005."
Mr. Drapeau continued, "In the next two months, we anticipate passing two important product development milestones. We expect to file for approval of Aryplase(TM) in the United States and European Union. Additionally, we plan to initiate a Phase 2 study of Phenoptin(TM) in phenylketonuria (PKU) patients and to discuss key elements of our PKU clinical development plan with the FDA. On a final note, the Board of Directors has interviewed several highly qualified candidates for the permanent CEO position at BioMarin."
BioMarin recorded $0.2 million in net sales of Orapred(R) (prednisolone sodium phosphate oral solution) for the third quarter and $4.7 million for the nine months ended September 30, 2004. BioMarin began recording sales of Orapred after the close of the acquisition of the Ascent Pediatrics business from Medicis Pharmaceutical Corporation, which occurred on May 18, 2004. Prescriptions of Orapred for the first nine months of the 2004 increased 6 percent over the same period in 2003 (IMS; NPA).
Net sales of Aldurazyme(R) (laronidase) recorded by BioMarin/Genzyme LLC were $10.3 million for the third quarter ended September 30, 2004 compared to $3.4 million for the third quarter ended September 30, 2003. Aldurazyme was launched by Genzyme Corporation in the United States in May 2003 and in the European Union in June 2003. Net sales recorded by BioMarin/Genzyme LLC for the nine months ended September 30, 2004 were $27.0 million compared to $4.9 million for the same period in 2003. BioMarin's 50 percent share of the loss from BioMarin/Genzyme LLC for the third quarter ended September 30, 2004 was $0.5 million.
BioMarin's net loss in the third quarter of 2004 included: $12.8 million in selling, general and administrative expenses; $3.8 million in non-cash expenses related to the acquisition of the Ascent Pediatrics business from Medicis Pharmaceutical; $5.7 million in ongoing research and development expenses related to Aryplase(TM) (galsulfase) for the treatment of mucopolysaccharidosis VI; and research and development expenses of $2.6 million related to the advancement of the company's PKU clinical development program.
Third Quarter Program Highlights
Investigational New Drug Application (IND) Filed With the U.S. Food and Drug Administration (FDA) for Phenoptin(TM) (6R-BH4) for PKU
On August 24, 2004, BioMarin announced it had filed an IND with the FDA for Phenoptin, a proprietary oral formulation of 6R-BH4. The company expects to initiate a Phase 2 clinical trial of Phenoptin based on this IND by the end of 2004.
Positive Phase 1b Clinical Data on Vibrilase(TM) (Vibriolysin) for Serious Burns
On August 25, 2004, BioMarin announced positive results from its Phase 1b clinical trial for Vibrilase, a topical enzyme for the treatment of serious burns. Data from the trial suggest that treatment with Vibrilase is generally safe and well-tolerated, and effective in debriding partial-thickness burns.
BioMarin will host a conference call and webcast to discuss third quarter financial results today at 12:00 PM EST (18:00 CET). This event can be accessed on the BioMarin website at: http://investor.biomarinpharm.com/ .
Date: November 3, 2004 Time: 12:00 PM EST (18:00 CET) U.S. & Canada Toll-free Dial in #: 800-706-7741 International Dial in #: 617-614-3471 Participant Pass Code: 34306670 Replay Toll-free Dial in #: 888-286-8010 Replay International Dial in #: 617-801-6888 Replay Code #: 98459011
BioMarin Pharmaceutical Inc. develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the performance of BioMarin's product Orapred and BioMarin/Genzyme LLC's product Aldurazyme; the financial performance of the company as a whole; the continued development and commercialization of Aldurazyme, Aryplase and Phenoptin; and actions by regulatory authorities. 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: our joint venture partner's success in continuing the commercialization or Aldurazyme; results and timing of current and planned preclinical studies and clinical trials; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities concerning each of the described products; the market for each of these products and particularly Aldurazyme and Orapred; actual sales of Aldurazyme and Orapred; the possible development of competing products; the effect on sales of Orapred following the recent approval of a generic product that is therapeutically equivalent to Orapred; 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 2003 Annual Report on Form 10-K and the factors contained in BioMarin's reports on Forms 10-Q and 8-K. 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.
NOTE: Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.
Orapred(R) and Ascent(R) are registered trademarks of Medicis Pediatrics, Inc., and are used under license.
Contacts:
Joshua A. Grass
Sr. Manager, Investor & Financial Relations
BioMarin Pharmaceutical Inc.
415-506-6777
Susan Ferris
Manager, Corporate Communications
BioMarin Pharmaceutical Inc.
415-506-6701
Consolidated Balance Sheets
(In thousands, except share and per share data)
December 31, September 30,
2003 2004
(unaudited)
Assets
Current assets:
Cash and cash equivalents $121,406 $34,981
Short-term investments 84,951 51,570
Restricted cash -- 25,198
Accounts receivable -- 119
Inventory -- 3,090
Investment in and advances to
BioMarin/Genzyme LLC 16,058 22,650
Other current assets 2,854 3,079
Total current assets 225,269 140,687
Property and equipment, net 25,154 35,620
Acquired intangible assets, net -- 99,123
Goodwill -- 32,250
Other assets 5,917 4,550
Total assets $256,340 $312,230
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $10,098 $24,541
Current portion of acquisition obligation,
net of discount -- 48,747
Other current liabilities 2,717 2,427
Total current liabilities 12,815 75,715
Convertible debt 125,000 125,000
Equipment and facility loan -- 6,986
Long-term portion of acquisition obligation,
net of discount -- 90,076
Other long-term liabilities 672 290
Total liabilities 138,487 298,067
Stockholders' equity:
Common stock, $0.001 par value: 150,000,000
shares authorized; 64,156,285 and
64,388,138 shares issued and outstanding
December 31, 2003 and September 30, 2004,
respectively 64 64
Additional paid-in capital 414,110 420,758
Warrants 5,219 --
Deferred compensation (145) --
Accumulated other comprehensive loss (17) (260)
Accumulated deficit (301,378) (406,399)
Total stockholders' equity 117,853 14,163
Total liabilities and stockholders' equity $256,340 $312,230
Consolidated Statements of Operations
For the Three and Nine Months Ended September 30, 2003 and 2004
(In thousands, except per share data, unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2003 2004 2003 2004
Net product sales $-- $181 $-- $4,744
Milestone revenue -- -- 12,100 --
Total revenue -- 181 12,100 4,744
Operating expenses:
Cost of sales (excludes
amortization of
developed product
technology) -- 35 -- 648
Research and
development 14,211 11,806 36,784 37,670
Selling, general and
administrative 1,956 12,761 9,364 24,304
Amortization of acquired
intangible assets -- 1,694 -- 2,513
Acquired in-process
research and development -- -- -- 35,444
Equity in the loss of
BioMarin/Genzyme LLC 4,503 507 16,642 3,965
Total operating
expenses 20,670 26,803 62,790 104,544
Loss from operations (20,670) (26,622) (50,690) (99,800)
Interest income 781 573 1,787 1,997
Interest expense (1,402) (3,429) (1,745) (7,218)
Net loss from continuing
operations (21,291) (29,478) (50,648) (105,021)
Gain on disposal of
discontinued operations -- -- 577 --
Net loss $(21,291) $(29,478) $(50,071) $(105,021)
Net loss per share,
basic and diluted:
Net loss from
continuing operations $(0.33) $(0.46) $(0.82) $(1.63)
Gain on disposal
of discontinued
operations -- -- 0.01 --
Net loss $(0.33) $(0.46) $(0.81) $(1.63)
Weighted average
common shares
outstanding, basic
and diluted 63,815 64,384 61,450 64,316
SOURCE: BioMarin Pharmaceutical Inc.
CONTACT: Joshua A. Grass, Sr. Manager, Investor & Financial Relations,
+1-415-506-6777, or Susan Ferris, Manager, Corporate Communications,
+1-415-506-6701, both of both of BioMarin Pharmaceutical Inc.
Web site: http://www.bmrn.com/