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BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) today announced financial results for the third quarter ended September 30, 2007. The net loss was $5.2 million ($0.05 per share) for the third quarter of 2007, compared to a net loss of $7.0 million ($0.08 per share) for the third quarter of 2006. The net loss for the nine months ended September 30, 2007 was $18.4 million ($0.19 per share), compared to a net loss of $18.1 million ($0.22 per share) for the same period last year. Non-cash stock compensation expense for the three and nine months ended September 30, 2007 was $5.0 million and $12.8 million, respectively, compared to $2.7 million and $6.5 million, respectively, for the three and nine months ended September 30, 2006.
As of September 30, 2007, BioMarin had cash, cash equivalents, and short-term investments totaling $586.7 million.
"Our financial position is shaping up nicely with revenues from Naglazyme and Aldurazyme sales contributing to a reduced net loss for the third quarter of 2007 compared to our net loss for the third quarter of 2006," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We continue to advance our preclinical programs and are on track to file the IND for Phenylase in the current quarter. Additionally, our cash position remains strong and we will continue to pursue new growth opportunities to further augment our pipeline and long-term growth prospects."
Kuvan Regulatory Update
Based on BioMarin's NDA filing for Kuvan that was received on May 25, 2007, the FDA granted BioMarin priority review with a PDUFA date of November 25, 2007. Over the last several months, the FDA has expeditiously reviewed the application and as of October 23, initiated labeling discussions with the company. On Tuesday, October 30, the FDA notified BioMarin that, solely due to an unanticipated staffing constraint at the FDA and not due to any identified issues in the NDA, the action date has been moved to December 14.
"The FDA has assured us that the change of the action date is solely due to a staffing constraint," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "The FDA has committed to help us minimize the impact of the delay and to continue label discussions without interruption. We do not expect this minor change in the timeline to significantly impact our target launch date of mid-December."
Product Sales
Net sales of Naglazyme(R) (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), were $21.3 million for the third quarter of 2007, an increase of approximately 65.1 percent compared to net sales of $12.9 million for the third quarter of 2006. Net sales of Naglazyme for the nine months ended September 30, 2007 were $60.6 million, an increase of $30.4 million from net sales of $30.2 million for the nine months ended September 30, 2006. BioMarin is commercializing Naglazyme in the United States, Europe, and Latin America, 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 by approximately 29.2 percent to $32.3 million for the third quarter of 2007, compared to $25.0 million in the third quarter of 2006. Net sales of Aldurazyme for the nine months ended September 30, 2007 were $88.3 million, an increase of 26.3 percent compared to net sales of $69.9 million for the nine months ended September 30, 2006. BioMarin's share of the profit of BioMarin/Genzyme LLC was $8.4 million for the third quarter of 2007, compared to a profit of $5.1 million for the third quarter of 2006. For the nine months ended September 30, 2007, BioMarin's share of the profit of BioMarin/Genzyme LLC was $21.2 million, compared to a profit of $13.6 million for the nine months ended September 30, 2006.
Royalty and License Revenues
Royalty and license revenues for the third quarter of 2007 were $0.6 million, and include royalties on net product sales of the Orapred product line, including Orapred(R) (prednisolone sodium phosphate oral solution) and Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets). Royalty and license revenues for the third quarter of 2006 were $5.4 million. Royalty and license revenues for the nine months ended September 30, 2007 were $5.4 million and included a $4.0 million milestone payment related to the one-year anniversary of FDA approval of the marketing application for Orapred ODT. Royalty and license revenues for the nine months ended September 30, 2006 were $15.0 million and included a $7.5 million milestone payment received in June 2006 related to FDA approval of the marketing application for Orapred ODT and a $4.0 million milestone payment received in September 2006 related to the commercial launch of Orapred ODT.
2007 Financial Guidance Improved
BioMarin estimates 2007 net sales of Naglazyme to be in the range of $82 million to $84 million from a previous range of $76 million to $82 million. Sales of Aldurazyme by the joint venture for 2007 are still expected to be in the range of $115 million to $125 million. BioMarin estimates its GAAP net loss for the fiscal year ending December 31, 2007 to be in the range of $13 million to $18 million from a previous range of $18 million to $23 million. This includes approximately $18 million in non-cash stock compensation expense.
Anticipated Upcoming Milestones
* Q407: Receipt of $15 million milestone payment related to the acceptance
of Merck Serono's MAA filing
* Q407: FDA decision on Kuvan NDA
* Q407: Phenylase IND filing
* Q407/Q108: Kuvan launch in the U.S.
* Q108: Initiation of Phenylase Phase I patient study
Upcoming Investor Conferences
* November 5-7: Rodman & Renshaw 9th Annual Healthcare Conference -- New
York City
* November 12: Citigroup Biotech Day -- New York City
* November 13-15: Credit Suisse Healthcare Conference -- Phoenix
BioMarin will host a conference call and webcast to discuss second quarter 2007 financial results today, Thursday, November 1, at 5:00 p.m. ET (22:00 CET). This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.
Date: November 1, 2007 Time: 5:00 p.m. ET (22:00 CET) U.S. / Canada Dial-in Number: 866.713.8307 International Dial-in Number: 617.597.5307 Participant Code: 48736710 Replay Dial-in Number: 888.286.8010 Replay International Dial-in Number: 617.801.6888 Replay Code: 41531207 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(R) (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 Kuvan(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 peripheral arterial disease and sickle cell disease. For additional information, please visit www.BMRN.com. Information on BioMarin's website 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 product Naglazyme and BioMarin/Genzyme LLC's product Aldurazyme; Sciele Pharma's commercialization of Orapred ODT; the financial performance of the BioMarin as a whole; the timing of BioMarin's clinical trials of 6R-BH4 for other indications; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, and 6R-BH4 for other indications; actions by regulatory authorities, including actions related to Kuvan, and 6R-BH4 for other indications; and expectations regarding actions by Merck Serono related to filing the marketing authorization application for Kuvan. 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 the continued commercialization of Naglazyme; our joint venture partner's success in continuing the commercialization of Aldurazyme; Sciele Pharma's success in commercializing Orapred ODT; results and timing of current and planned preclinical studies and clinical trials; our ability to successfully manufacture our products and product candidates; 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 ODT; actual sales of Aldurazyme, Naglazyme and Orapred ODT; Merck Serono's activities related to Kuvan; 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 2006 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.
BioMarin(R) and Naglazyme(R) are a registered trademarks of BioMarin Pharmaceutical Inc.
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.
Contact:
Investors Media
Eugenia Shen Susan Berg
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 506-6570 (415) 506-6594
Net Product Sales of BioMarin Pharmaceutical Inc. and BioMarin/Genzyme LLC
For the Three and Nine Months Ended September 30, 2006 and 2007
(In millions, unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2006 2007 2006 2007
Aldurazyme (as reported
by BioMarin/Genzyme LLC)(1) $25.0 $32.3 $69.9 $88.3
Naglazyme 12.9 21.3 30.2 60.6
(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.
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three and Nine Months Ended, September 30, 2006 and 2007
(In thousands, except for per share data, unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2006 2007 2006 2007
Revenues:
Net product sales $14,660 $21,325 $33,297 $60,600
Collaborative agreement
revenues 4,908 3,107 13,857 10,758
Royalty and license
revenues 5,359 574 15,036 5,369
Total revenues 24,927 25,006 62,190 76,727
Operating expenses:
Cost of sales 2,612 4,460 5,124 13,135
Research and development 18,105 17,241 46,163 54,585
Selling, general and
administrative 12,292 19,713 35,059 53,647
Amortization of acquired
intangible assets 1,093 1,093 2,558 3,278
Total operating expenses 34,102 42,507 88,904 124,645
Loss from operations (9,175) (17,501) (26,714) (47,918)
Equity in the income of
BioMarin/Genzyme LLC 5,059 8,446 13,604 21,159
Interest income 4,003 7,948 8,738 18,549
Interest expense (3,608) (4,109) (10,455) (10,163)
Debt conversion expense (3,315) - (3,315) -
Net loss $(7,036) $(5,216) $(18,142) $(18,373)
Net loss per share, basic
and diluted $(0.08) $(0.05) $(0.22) $(0.19)
Weighted average common
shares outstanding, basic
and diluted 86,269 96,199 82,232 95,523
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, 2006 and September 30, 2007
(In thousands, except for share and per share data)
December 31, September 30,
2006 2007
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $89,162 $291,825
Short-term investments 199,685 294,861
Accounts receivable, net 14,670 15,968
Advances to BioMarin/Genzyme LLC 1,596 1,953
Inventory 25,075 31,551
Other current assets 4,036 5,076
Total current assets 334,224 641,234
Investment in BioMarin/Genzyme LLC 31,457 35,516
Property, plant and equipment, net 55,466 66,249
Acquired intangible assets, net 11,655 8,377
Goodwill 21,262 21,262
Restricted cash 1,731 3,632
Other assets 7,641 14,786
Total assets $463,436 $791,056
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $32,166 $35,874
Current portion of acquisition obligation,
net of discount 6,787 6,549
Current portion of deferred revenue 7,092 6,639
Total current liabilities 46,045 49,062
Convertible debt 223,940 497,375
Long-term portion of acquisition obligation,
net of discount 68,548 66,946
Deferred revenue, net of current portion 5,023 274
Other long-term liabilities 2,078 2,854
Total liabilities 345,634 616,511
Stockholders' equity:
Common stock, $0.001 par value: 150,000,000
and 250,000,000 shares authorized at
December 31, 2006 and September 30, 2007,
respectively; 91,725,528 and 96,644,549
shares issued and outstanding at December 31,
2006 and September 30, 2007, respectively 92 97
Additional paid-in capital 709,359 784,317
Accumulated other comprehensive loss (25) 128
Accumulated deficit (591,624) (609,997)
Total stockholders' equity 117,802 174,545
Total liabilities and stockholders'
equity $463,436 $791,056
First Call Analyst:
FCMN Contact: eshen@bmrn.com
SOURCE: BioMarin Pharmaceutical Inc.
CONTACT: Investors, Eugenia Shen, +1-415-506-6570, or Media, Susan Berg,
+1-415-506-6594, both of BioMarin Pharmaceutical Inc.
Web site: http://www.bmrn.com/