NOVATO, Calif., Aug. 2 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. today announced results for its second quarter ended June 30, 2006. The net loss was $1.3 million ($0.02 per share) for the second quarter of 2006, compared to $21.3 million ($0.33 per share) for the second quarter of 2005. The net loss was $11.1 million ($0.14 per share) for the six months ended June 30, 2006, compared to $43.8 million ($0.68 per share) for the six months ended June 30, 2005.
“Our launch of Naglazyme is going very well and is exceeding our prior expectations,” stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. “As a result, we expect 2006 net product sales of Naglazyme to be about 30 percent greater than we had previously projected and our net loss for 2006 to be substantially lower as well.” Mr. Bienaime continued, “With regard to our product pipeline, we remain on track to file a New Drug Application for Phenoptin for PKU at the end of the first quarter of 2007 and to announce data from the Phase 2 study of 6R-BH4 for the treatment of poorly controlled hypertension in early 2007.”
Product Sales
Net sales of Naglazyme(TM) (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), for the second quarter of 2006 were $10.3 million and $17.3 million for the six months ended June 30, 2006. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) on May 31, 2005, and by the European Commission in late January 2006. BioMarin is commercializing Naglazyme in the United States and Europe and through distributors in other international markets.
Net sales of Aldurazyme(R) (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I, (MPS I) by BioMarin/Genzyme LLC increased 23 percent to $23.5 million for the second quarter of 2006, compared to $19.2 million in the second quarter of 2005. Net sales for the six months ended June 30, 2006 were $44.9 million, compared to $35.1 million for the same period in 2005, representing an increase of approximately 28 percent. BioMarin’s share of the profit of BioMarin/Genzyme LLC was $4.7 million for the second quarter of 2006, compared to a profit of $3.3 million for the second quarter of 2005. BioMarin’s share of the profit from BioMarin/Genzyme LLC for the six months ended June 30, 2006 was $8.5 million, compared to $5.4 million for the six months ended June 30, 2005.
Royalty and License Revenues
Royalty and license revenues for the second quarter and six months of 2006 were $9.4 million and $9.7 million, respectively, and include receipt of a one-time milestone payment of $7.5 million from Alliant Pharmaceuticals, following FDA approval of Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets), amortization of the $2.5 million upfront license payment received from Alliant in March 2006, and royalties on net product sales of the Orapred product line, including Orapred(R) (prednisolone sodium phosphate oral solution) and authorized generic products. Pursuant to a licensing and acquisition agreement entered into with Alliant Pharmaceuticals on March 15, 2006, BioMarin will receive additional milestone payments contingent on the launch of Orapred ODT, which is expected to occur in early September of 2006, and on the first anniversary of FDA-approval of Orapred ODT in June 2007.
As of June 30, 2006 BioMarin had cash, cash equivalents and short-term investments totaling $305.9 million.
Financial Guidance 2006 Projected Net Product Sales
BioMarin has updated its net sales guidance for Naglazyme for the fiscal year ending December 31, 2006. BioMarin estimates 2006 net sales of Naglazyme to be in the range of $40 million to $44 million, compared to the previously estimated range of $31 million to $34 million.
BioMarin and Genzyme Corporation reconfirm estimated sales of Aldurazyme through the joint venture for 2006 to be in a range of $90 million to $100 million.
2006 Projected Net Loss
BioMarin has improved its estimated GAAP net loss for the fiscal year ending December 31, 2006 from a range of $42 million to $45 million to a range of $33 million to $37 million, which includes $8.4 million of expenses related to the 2004 acquisition of Orapred and $8.3 million of stock compensation expense.
Recent Events and Second Quarter 2006 Highlights -- On July 6, BioMarin announced that it had initiated a Phase 2 clinical study of 6R-BH4 for the treatment of poorly controlled hypertension. The company expects to announce data from this trial in early 2007. -- On June 1, BioMarin and Alliant Pharmaceuticals announced that the FDA had granted marketing approval for Orapred ODT, the first orally disintegrating tablet form of prednisolone available in the United States. Alliant expects to begin marketing Orapred ODT in the United States in early September. Presentations at Upcoming Scientific Conferences
Researchers will present data pertaining to BioMarin’s marketed products and clinical-stage programs, namely Phenoptin(TM) (sapropterin dihydrochloride) for the treatment of phenylketonuria (PKU) and 6R-BH4 for the treatment of cardiovascular indications, at the scientific conferences listed below:
-- Tetrahydrobiopterin and Alternative Treatments for Phenylketonuria, Cardiovascular Diseases and Diabetes Satellite Meeting to the 2006 International Congress on Inborn Errors of Metabolism September 10 - 11, 2006, Sendai, Japan http://www.pku-bh4.com -- 10th International Congress of Inborn Errors of Metabolism September 12 - 16, 2006, Chiba, Japan http://www.iciem2006.org -- 56th Annual Meeting of the American Society of Human Genetics October 9 - 13, 2006, New Orleans, Louisiana http://www.ashg.org
BioMarin will host a conference call and webcast to discuss second quarter financial results today, Wednesday, August 2, at 5:00 p.m. EDT (23:00 CEST). This event can be accessed on the investor section of the BioMarin website at www.BMRN.com .
Date: August 2, 2006 Time: 5:00 p.m. EDT (23:00 CEST) U.S. & Canada Toll-free Dial in #: 866-271-0675 International Dial in #: 617-213-8892 Participant Code: 93530506 Replay Toll-free Dial in #: 888-286-8010 Replay International Dial in #: 617-801-6888 Replay Code: 52624487 About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio is comprised of two 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, and Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation. Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU), and 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of poorly controlled hypertension. For additional information, please visit www.BMRN.com . Information on BioMarin’s website is not incorporated by reference into this press release.
The websites indicated in this press release are provided by BioMarin as additional information for interested parties. With the exception of its own websites, BioMarin does not endorse any particular organization or the content contained on their website.
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 product Naglazyme and BioMarin/Genzyme LLC’s product Aldurazyme; Alliant Pharmaceuticals’ commercialization of Orapred ODT; the financial performance of the BioMarin as a whole; the timing of BioMarin’s clinical trials of Phenoptin and 6R-BH4 for other indications; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Phenoptin, and 6R-BH4 for other indications; and actions by regulatory authorities, including actions related to Naglazyme, Phenoptin, and 6R-BH4 for other indications. 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; our joint venture partner’s success in continuing the commercialization of Aldurazyme; Alliant Pharmaceuticals’ success in commercializing Orapred ODT; results and timing of current and planned preclinical studies and clinical trials, including the Phase 3 clinical trial of Phenoptin and 6R-BH4 for other indications; 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; product returns of Orapred; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s 2005 Annual Report on Form 10-K, as amended, and the factors contained in BioMarin’s reports on 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. NOTE: 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 Pharmaceutical Inc. and BioMarin/Genzyme LLC For the Three and Six Months Ended June 30, 2005 and 2006 (In millions, except per share data, unaudited) Three Months Ended Six Months Ended June 30, June 30, 2005 2006 2005 2006 Aldurazyme (as reported by BioMarin/Genzyme LLC) (1) $19.2 $23.5 $35.1 $44.9 Naglazyme 0.1 10.3 0.1 17.3 Orapred (2) 1.3 (0.6) 6.3 1.3 (1) The Company recognizes its 50% share of the net income of BioMarin/Genzyme LLC as Equity in the income of BioMarin/Genzyme LLC in the Company’s consolidated statements of operations. (2) For the three months ended June 30, 2006, the Company recognized net Orapred product return expense of $0.6 million. BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS For the Three and Six Months Ended, June 30, 2005 and 2006 (In thousands, except for per share data, unaudited) Three Months Ended Six Months Ended June 30, June 30, 2005 2006 2005 2006 Revenues: Net product sales $1,437 $9,657 $6,426 $18,636 Collaborative agreement revenues 2,189 4,435 2,189 8,949 Royalty and license revenues -- 9,358 -- 9,677 Total revenues 3,626 23,450 8,615 37,262 Operating expenses: Cost of sales (excludes amortization of developed product technology) 478 789 1,137 2,512 Research and development 14,822 15,779 29,814 28,058 Selling, general and administrative 10,117 11,871 20,684 22,767 Amortization of acquired intangible assets 286 1,093 572 1,466 Total operating expenses 25,703 29,532 52,207 54,803 Equity in the income of BioMarin/Genzyme LLC 3,303 4,745 5,378 8,545 Loss from operations (18,774) (1,337) (38,214) (8,996) Interest income 374 4,034 615 4,736 Interest expense (2,940) (4,022) (6,199) (6,846) Net loss $(21,340) $(1,325) $(43,798) $(11,106) Net loss per share, basic and diluted $(0.33) $(0.02) $(0.68) $(0.14) Weighted average common shares outstanding, basic and diluted 64,605 85,341 64,558 80,181 BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands, except for share and per share data) December 31, June 30, 2005 (1) 2006 (unaudited) ASSETS Current assets Cash and cash equivalents $38,092 $285,990 Short-term investments 9,700 19,910 Accounts receivable, net 5,860 10,946 Advances to BioMarin/Genzyme LLC 1,071 926 Inventory 10,898 24,247 Other current assets 3,320 2,788 Total current assets 68,941 344,807 Cash balances related to long-term debt 17,049 -- Investment in BioMarin/Genzyme LLC 31,983 28,528 Property and equipment, net 37,321 51,615 Acquired intangible assets, net 15,306 13,841 Goodwill 21,262 21,262 Other assets 3,441 8,661 Total assets $195,303 $468,714 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities: Accounts payable and accrued liabilities $20,934 $23,073 Current portion of acquisition obligation, net of discount 7,477 6,705 Current portion of deferred revenue 8,096 8,226 Current portion of equipment and facility loans 3,860 -- Total current liabilities 40,367 38,004 Convertible debt 125,000 297,500 Long-term portion of acquisition obligation, net of discount 70,873 69,811 Deferred revenue, net of current portion 11,825 7,990 Equipment and facility loan, net of current portion 17,049 -- Other long-term liabilities 7,651 6,522 Total liabilities 272,765 419,827 Stockholders’ equity (deficit): Common stock, $0.001 par value: 150,000,000 shares authorized; 74,301,610 and 85,470,948 shares issued and outstanding at December 31, 2005 and June 30, 2006, respectively 75 85 Additional paid-in capital 485,570 623,048 Accumulated other comprehensive loss (16) (49) Accumulated deficit (563,091) (574,197) Total stockholders’ equity (deficit) (77,462) 48,887 Total liabilities and stockholders’ equity (deficit) $195,303 $468,714 (1) December 31, 2005 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, both of BioMarin Pharmaceutical Inc.
Web site: http://www.bmrn.com/
