NOVATO, Calif., Nov. 1 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. today announced results for its third quarter ended September 30, 2005. The net loss was $15.5 million ($0.21 per share) for the third quarter of 2005 compared to $29.5 million ($0.46 per share) for the third quarter of 2004. The net loss was $59.3 million ($0.88 per share) for the nine months ended September 30, 2005, compared to $105.0 million ($1.63 per share) for the nine months ended September 30, 2004.
“We are pleased with the continued sales and profitability growth of Aldurazyme through the BioMarin/Genzyme LLC joint venture and with the progress we have made recently in getting MPS VI patients onto commercial therapy with Naglazyme,” stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. “We have improved our financial guidance for 2005 and remain committed to managing our resources judiciously as we continue to advance our product pipeline.” Mr. Bienaime continued, “Enrollment in the Phase 3 trial of Phenoptin for PKU is going well and we remain on track to announce data from the double-blind portion of the trial in late March of 2006.”
Net sales of Aldurazyme(R) (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I, (MPS I) by BioMarin/Genzyme LLC increased 95 percent to $20.1 million for the third quarter of 2005, compared to $10.3 million in the third quarter of 2004. Net sales for the nine months ended September 30, 2005 were $55.2 million compared to $27.0 million for the same period in 2004, representing an increase of 104 percent. BioMarin’s share of the profit from BioMarin/Genzyme LLC was $3.4 million for the third quarter of 2005, compared to a loss of $0.5 million for the third quarter of 2004. BioMarin’s share of the profit from BioMarin/Genzyme LLC for the nine months ended September 30, 2005, was $8.8 million, compared to a loss of $4.0 million for the nine months ended September 30, 2004.
Net sales of Naglazyme(TM) (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), were $2.3 million for the third quarter of 2005, and $2.4 million for the nine months ended September 30, 2005. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) on May 31, 2005 and launched by BioMarin’s U.S.-based sales force on June 20, 2005. The FDA has designated Naglazyme an orphan drug, which grants it seven years of market exclusivity in the United States. In mid-September 2005, the scientific committee of the European Medicines Agency (EMEA) issued a positive opinion on the Marketing Authorization Application (MAA) for Naglazyme. BioMarin plans to commercialize Naglazyme in the European Union on its own with a small and efficient E.U.-based sales force, pending final approval by the European Commission.
Net sales of Orapred(R) (prednisolone sodium phosphate oral solution), including the branded and authorized generic products, of $0.2 million for the third quarter of 2005 were flat compared to net sales in the same period of 2004. Orapred net sales recorded by BioMarin for the nine months ended September 30, 2005 were $6.5 million compared to $4.7 million for the same period in 2004. BioMarin began recording sales of Orapred in May 2004 at the time the product was acquired.
As of September 30, 2005, BioMarin had cash, cash equivalents, short-term investments and cash balances related to long-term debt of approximately $83.9 million.
Financial Guidance
2005 Projected Net Product Sales
BioMarin has revised its 2005 product revenue guidance for the fiscal year ending December 31, 2005:
-- Aldurazyme for MPS I: A range of $74 million to $77 million (increased from a range of $70 million to $75 million) -- Naglazyme for MPS VI: A range of $4 million to $6 million (unchanged) -- Orapred for inflammatory conditions: A range of $7 million to $8 million (decreased from a range of $8 million to $10 million) 2005 Projected Net Loss and End of Year Cash Balance
BioMarin has revised its 2005 financial guidance for projected net loss and end of year cash balance for the fiscal year ending December 31, 2005:
-- GAAP net loss: A range of $73 million to $78 million, which includes $6.7 million of Orapred deal-related expenses (decreased from a range of $75 million to $80 million) -- End of year cash balance: A range of $59 million to $64 million in cash, cash equivalents, short-term investments and cash balances related to long-term debt (increased from a range of $55 million to $60 million) Recent Events and Third Quarter 2005 Highlights -- On September 15, BioMarin announced that it had received a positive opinion from the EMEA on the MAA for Naglazyme for MPS VI. -- On August 22, Brazilian regulatory authorities approved Aldurazyme for the treatment of MPS I. -- On October 19, BioMarin announced that the FDA had accepted for filing the New Drug Application for Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets) for the treatment of inflammatory conditions. The company expects to receive a response from the FDA by mid-2006. -- On August 23, BioMarin announced the promotion of Jeffrey Cooper to the position of Chief Financial Officer. Mr. Cooper succeeds Louis Drapeau who retired at the end of October 2005. Upcoming Company Events
On Tuesday, December 6, 2005, BioMarin will host a “Research and Development Day” to discuss the company’s products and product pipeline. The event, which will be held at the Four Seasons Hotel located in New York City, New York, will take place from 7:30 a.m. to 10:30 a.m. ET. Interested parties can access a live audio web cast of the event via the investor section of the BioMarin website, www.BMRN.com.
Upcoming Company Milestones
BioMarin expects to continue to advance its product and clinical-stage product portfolio in the coming months. The following is a list of the company’s projected near-term milestones:
-- Announce the outcome of the European Commission’s review of the MAA for Naglazyme (first quarter of 2006) -- Announce data from the Phase 3 clinical trial of Phenoptin(TM) (sapropterin dihydrochloride) for the treatment of PKU (late March of 2006)
BioMarin will host a conference call and webcast to discuss third quarter financial results Wednesday, November 2, at Noon ET (18:00 CET). This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.
Date: November 2, 2005 Time: Noon ET (18:00 CET) U.S. & Canada Toll-free Dial in #: 866.700.0133 International Dial in #: 617.213.8831 Participant Code: 78103268 Replay Toll-free Dial in #: 888.286.8010 Replay International Dial in #: 617.801.6888 Replay Code: 32265695 About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio is comprised of three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme(TM) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin, Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), and Orapred(R) (prednisolone sodium phosphate oral solution) for inflammatory conditions. Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU). For additional information, please visit www.BMRN.com.
Information on BioMarin’s website, www.BMRN.com, is not incorporated by reference into this press release.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the sales expectations of BioMarin’s products Naglazyme and Orapred (including its branded and authorized generic products) and BioMarin/Genzyme LLC’s product Aldurazyme; the financial performance of the BioMarin as a whole; the timing of BioMarin’s clinical trials of Phenoptin; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Orapred, and Phenoptin; and actions by regulatory authorities, including actions related to Naglazyme, Orapred and Phenoptin. 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 success in continuing commercialization of Naglazyme and Orapred; our joint venture partner’s success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical trials, including the Phase 3 clinical trial of Phenoptin; 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 and product candidates; the market for each of these products and particularly Aldurazyme, Naglazyme and Orapred; actual sales of Aldurazyme, Naglazyme and 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 2004 Annual Report on Form 10-K, as amended, and the factors contained in BioMarin’s reports on Form 10-Q and Form 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.
Orapred(R) is a registered trademark of Medicis Pediatrics, Inc. and is used under license. Contacts: Investors Media Joshua A. Grass Susan Ferris BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. 415-506-6777 415-506-6701 NET PRODUCT SALES OF BIOMARIN AND BIOMARIN/GENZYME LLC For the Three and Nine Months Ended September 30, 2004 and 2005 (in millions, unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2004 2005 2004 2005 Aldurazyme (as reported by Bio/Marin/Genzyme LLC) (1) $10.3 $20.1 $27.0 $55.2 Orapred 0.2 0.2 4.7 6.5 Naglazyme -- 2.3 -- 2.4
(1) The company recognizes its 50% share of the net income/loss of BioMarin/Genzyme LLC as Equity in the loss/(income) of BioMarin/Genzyme LLC in the company’s consolidated statements of operations.
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS For the Three and Nine Months Ended September 30, 2004 and 2005 (In thousands, except for per share data, unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2004 2005 2004 2005 Revenues: Net product sales $181 $2,456 $4,744 $8,881 Collaborative agreement revenues -- 5,123 -- 7,313 Total revenues 181 7,579 4,744 16,194 Operating expenses: Cost of sales (excludes amortization of developed product technology) 35 164 648 1,301 Research and development 11,806 13,894 37,670 43,708 Selling, general and administrative 12,761 9,797 24,304 30,480 Amortization of acquired intangible assets 1,694 286 2,513 858 Acquired in-process research and development -- -- 35,444 -- Total operating expenses 26,296 24,141 100,579 76,347 Equity in the loss/ (income) of BioMarin/ Genzyme LLC 507 (3,388) 3,965 (8,766) Loss from operations (26,622) (13,174) (99,800) (51,387) Interest income 573 561 1,997 1,177 Interest expense (3,429) (2,863) (7,218) (9,064) Net loss $(29,478) $(15,476) $(105,021) $(59,274) Net loss per share, basic and diluted $(0.46) $(0.21) $(1.63) $(0.88) Weighted average common shares outstanding, basic and diluted 64,384 71,996 64,316 67,047 BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands, except for share and per share data) December 31, September 30, 2004(1) 2005 (unaudited) ASSETS Current assets: Cash and cash equivalents $13,081 $56,213 Short-term investments 35,734 9,700 Restricted cash 25,180 -- Accounts receivable, net 4,047 5,328 Advances to BioMarin/Genzyme LLC 2,160 852 Inventory 2,316 7,720 Other current assets 2,641 2,375 Total current assets 85,159 82,188 Cash balances related to long-term debt 16,406 18,014 Investment in BioMarin/Genzyme LLC 23,129 30,411 Property and equipment, net 42,501 37,799 Acquired intangible assets, net 16,451 15,592 Goodwill 45,053 21,262 Other assets 4,267 3,576 Total assets $232,966 $208,842 LIABILITIES AND STOCKHOLDERS’ DEFICIT Current liabilities: Accounts payable and accrued liabilities $27,249 $22,936 Current portion of acquisition obligation, net of discount 39,122 7,812 Current portion of equipment and facility loans 3,683 3,884 Current portion of deferred revenue -- 9,592 Total current liabilities 70,054 44,224 Convertible debt 125,000 125,000 Long-term portion of acquisition obligation, net of discount 86,632 71,433 Equipment and facility loan, net of current portion 16,406 18,014 Deferred revenue, net of current portion -- 12,500 Other long-term liabilities 2,852 3,050 Total liabilities 300,944 274,221 Stockholders’ deficit: Common stock, $0.001 par value: 150,000,000 shares authorized; 64,501,159 and 73,860,139 shares issued and outstanding at December 31, 2004 and September 30, 2005, respectively 65 74 Additional paid-in capital 421,141 482,658 Accumulated other comprehensive loss (363) (16) Accumulated deficit (488,821) (548,095) Total stockholders’ deficit (67,978) (65,379) Total liabilities and stockholders’ deficit $232,966 $208,842 (1) December 31, 2004 balances were derived from the audited consolidated financial statements.
BioMarin Pharmaceutical Inc.
CONTACT: investors, Joshua A. Grass, +1-415-506-6777, or media, SusanFerris, +1-415-506-6701, or BioMarin Pharmaceutical Inc.
Web site: http://www.bmrn.com/
