Exhibit 99.1
Contact:
| | | | | | |
| Investors | | | | | | Media |
Eugenia Shen BioMarin Pharmaceutical Inc. (415) 506-6570 | | | | | | Susan Berg BioMarin Pharmaceutical Inc. (415) 506-6594 |
For Immediate Release:
BioMarin Announces Second Quarter 2007 Financial Results
Continued Naglazyme Momentum Drives Record Revenues
Conference Call and Webcast to Be Held Today at 5:00 p.m. ET (23:00 CET)
Novato, Calif., August 7, 2007 – BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) today announced financial results for its second quarter ended June 30, 2007. The net loss was $3.9 million ($0.04 per share) for the second quarter of 2007, compared to a net loss of $1.3 million ($0.02 per share) for the second quarter of 2006. The net loss during the second quarter of 2007 includes $4.3 million of non-cash stock compensation expense, compared to $2.1 million of non-cash stock compensation expense during the second quarter of 2006. The results also include Orapred milestone revenue of $4.0 million recognized in the second quarter of 2007, down from the $9.2 million in milestone and license revenue that was recognized in the second quarter of 2006. The reduced Orapred milestone and license revenue contributed to the increased net loss in the second quarter of 2007 as compared to the second quarter of 2006. The net loss for the six months ended June 30, 2007 was $13.2 million ($0.14 per share), compared to a net loss of $11.1 million ($0.14 per share) for the six months ended June 30, 2006. Non-cash stock compensation expense for the six months ended June 30, 2007 and June 30, 2006 was $7.8 million and $3.8 million, respectively.
As of June 30, 2007, BioMarin had cash, cash equivalents, and short-term investments totaling $587.7 million.
“Strong Naglazyme sales for first half of 2007 are driving bottom-line results and fueling the development of our pipeline,” said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. “Our Kuvan program is progressing on track, with three important milestones achieved recently: submission of the NDA filing, initiation of the expanded access program, and two weeks ago, receipt of priority review status. The expanded access program is actively enrolling patients, and we are hopeful that Kuvan will receive FDA approval by the end of November.”
Product Sales
Net sales of Naglazyme® (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), were $20.9 million for the second quarter of 2007, compared to $18.4 million for the first quarter of 2007, representing a sequential increase of approximately 13.6 percent. Naglazyme net sales for the second quarter of 2006 were $10.3 million. Net sales of Naglazyme for the six months ended June 30, 2007 were $39.3 million, an increase of $22.0 million from net sales of $17.3 million for the six months ended June 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® (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I, (MPS I) by BioMarin/Genzyme LLC increased by approximately 23.8 percent to $29.1 million for the second quarter of 2007, compared to $23.5 million in the second quarter of 2006. Aldurazyme net sales for the first quarter of 2007 were $26.8 million. Net sales of Aldurazyme for the six months ended June 30, 2007 were $55.9 million, compared to net sales of $44.9 million for the six months ended June 30, 2006. BioMarin’s share of the profit of
Page 1 of 6
BioMarin/Genzyme LLC was $6.6 million for the second quarter of 2007, compared to a profit of $4.7 million for the second quarter of 2006. For the six months ended June 30, 2007, BioMarin’s share of the profit of BioMarin/Genzyme LLC was $12.7 million, compared to a profit of $8.5 million for the six months ended June 30, 2006.
Royalty and License Revenues
Royalty and license revenues for the second quarter of 2007 were $4.4 million, and include royalties on net product sales of the Orapred product line, including Orapred® (prednisolone sodium phosphate oral solution) and Orapred ODT™ (prednisolone sodium phosphate orally disintegrating tablets). This also includes a milestone payment of $4.0 million on the first anniversary of FDA approval of Orapred ODT in June 2007. Royalty and license revenues for the second quarter of 2006 were $9.4 million and include a $7.5 million milestone payment related to FDA approval of the marketing application for Orapred ODT. Royalty and license revenues for the six months ended June 30, 2007 were $4.8 million, compared to $9.7 million for the six months ended June 30, 2006.
2007 Financial Guidance Maintained
BioMarin estimates 2007 net sales of Naglazyme to be in the range of $76 million to $82 million. Sales of Aldurazyme by the joint venture for 2007 are 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 $18 million to $23 million. This includes approximately $16 million to $18 million in non-cash stock compensation expense.
Anticipated Upcoming Milestones
| | • | | Q307: Initiation of investigator-sponsored pulmonary arterial hypertension study |
| | • | | Q407: Receipt of $15 million milestone payment related to Merck Serono Kuvan MAA filing |
| | • | | Q407: Decision on the Kuvan NDA by the FDA |
| | • | | Q407: Phenylase IND filing |
Upcoming Investor Conferences
| | • | | September 10-11: Bear Stearns 20th Annual Healthcare Conference – New York City |
| | • | | September 18-20: Merrill Lynch Global Pharma, Biotech, Medtech Conference – London |
BioMarin will host a conference call and webcast to discuss second quarter 2007 financial results today, Tuesday, August 7, at 5:00 p.m. ET (23:00 CET). This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.
Date: August 7, 2007
Time: 5:00 p.m. ET (23:00 CET)
U.S. / Canada Dial-in Number: 800.510.9836
International Dial-in Number: 617.614.3670
Participant Code: 92042653
Replay Dial-in Number: 888.286.80106
Replay International Dial-in Number: 617.801.6888
Replay Code: 30005812
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® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin, and Aldurazyme® (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™ (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU), and 6R-BH4 for cardiovascular
Page 2 of 6
indications, which is currently in Phase 2 clinical development for the treatment of peripheral arterial 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® and Naglazyme® are a registered trademarks of BioMarin Pharmaceutical Inc.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
Orapred® is a registered trademark of Medicis Pediatrics, Inc. and is used under license.
# # #
Page 3 of 6
Net Product Sales of BioMarin Pharmaceutical Inc. and BioMarin/Genzyme LLC
For the Three and Six Months Ended June 30, 2006 and 2007
(In millions, unaudited)
| | | | | | | | | | | | |
| | | Three Months Ended
June 30, | | Six Months Ended
June 30, |
| | | 2006 | | 2007 | | 2006 | | 2007 |
Aldurazyme (as reported by BioMarin/Genzyme LLC) (1) | | $ | 23.5 | | $ | 29.1 | | $ | 44.9 | | $ | 55.9 |
Naglazyme | | | 10.3 | | | 20.9 | | | 17.3 | | | 39.3 |
| (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. |
Page 4 of 6
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three and Six Months Ended, June 30, 2006 and 2007
(In thousands, except for per share data, unaudited)
| | | | | | | | | | | | | | | | |
| | | Three Months Ended June 30, | | | Six Months Ended June 30, | |
| | | 2006 | | | 2007 | | | 2006 | | | 2007 | |
Revenues: | | | | | | | | | | | | | | | | |
Net product sales | | $ | 9,657 | | | $ | 20,941 | | | $ | 18,636 | | | $ | 39,276 | |
Collaborative agreement revenues | | | 4,435 | | | | 3,505 | | | | 8,949 | | | | 7,652 | |
Royalty and license revenues | | | 9,358 | | | | 4,438 | | | | 9,677 | | | | 4,795 | |
| | | | | | | | | | | | | | | | |
Total revenues | | | 23,450 | | | | 28,884 | | | | 37,262 | | | | 51,723 | |
| | | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | |
Cost of sales (excludes amortization of developed product technology) | | | 789 | | | | 4,557 | | | | 2,512 | | | | 8,674 | |
Research and development | | | 15,779 | | | | 19,186 | | | | 28,058 | | | | 37,345 | |
Selling, general and administrative | | | 11,871 | | | | 17,649 | | | | 22,767 | | | | 33,935 | |
Amortization of acquired intangible assets | | | 1,093 | | | | 1,093 | | | | 1,466 | | | | 2,185 | |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 29,532 | | | | 42,485 | | | | 54,803 | | | | 82,139 | |
| | | | | | | | | | | | | | | | |
Loss from operations | | | (6,082 | ) | | | (13,601 | ) | | | (17,541 | ) | | | (30,416 | ) |
Equity in the income of BioMarin/Genzyme LLC | | | 4,745 | | | | 6,550 | | | | 8,545 | | | | 12,713 | |
Interest income | | | 4,034 | | | | 6,907 | | | | 4,736 | | | | 10,601 | |
Interest expense | | | (4,022 | ) | | | (3,720 | ) | | | (6,846 | ) | | | (6,055 | ) |
| | | | | | | | | | | | | | | | |
Net loss | | $ | (1,325 | ) | | $ | (3,864 | ) | | $ | (11,106 | ) | | $ | (13,157 | ) |
| | | | | | | | | | | | | | | | |
Net loss per share, basic and diluted | | $ | (0.02 | ) | | $ | (0.04 | ) | | $ | (0.14 | ) | | $ | (0.14 | ) |
| | | | | | | | | | | | | | | | |
Weighted average common shares outstanding, basic and diluted | | | 85,341 | | | | 95,796 | | | | 80,181 | | | | 95,180 | |
| | | | | | | | | | | | | | | | |
Page 5 of 6
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31, 2006 and June 30, 2007
(In thousands, except for share and per share data)
| | | | | | | | |
| | | December 31,
2006 | | | June 30, 2007 | |
| | | | | | (unaudited) | |
ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 89,162 | | | $ | 205,010 | |
Short-term investments | | | 199,685 | | | | 382,700 | |
Accounts receivable, net | | | 14,670 | | | | 15,900 | |
Advances to BioMarin/Genzyme LLC | | | 1,596 | | | | 1,302 | |
Inventory | | | 25,075 | | | | 30,714 | |
Other current assets | | | 4,036 | | | | 5,306 | |
| | | | | | | | |
Total current assets | | | 334,224 | | | | 640,932 | |
Investment in BioMarin/Genzyme LLC | | | 31,457 | | | | 33,269 | |
Property, plant and equipment, net | | | 55,466 | | | | 58,780 | |
Acquired intangible assets, net | | | 11,655 | | | | 9,470 | |
Goodwill | | | 21,262 | | | | 21,262 | |
Restricted cash | | | 1,731 | | | | 3,103 | |
Other assets | | | 7,641 | | | | 14,823 | |
| | | | | | | | |
Total assets | | $ | 463,436 | | | $ | 781,639 | |
| | | | | | | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable and accrued liabilities | | $ | 32,166 | | | $ | 30,604 | |
Current portion of acquisition obligation, net of discount | | | 6,787 | | | | 6,785 | |
Current portion of deferred revenue | | | 7,092 | | | | 7,154 | |
| | | | | | | | |
Total current liabilities | | | 46,045 | | | | 44,543 | |
Convertible debt | | | 223,940 | | | | 497,375 | |
Long-term portion of acquisition obligation, net of discount | | | 68,548 | | | | 67,332 | |
Deferred revenue, net of current portion | | | 5,023 | | | | 1,509 | |
Other long-term liabilities | | | 2,078 | | | | 3,278 | |
| | | | | | | | |
Total liabilities | | | 345,634 | | | | 614,037 | |
| | | | | | | | |
Stockholders’ equity: | | | | | | | | |
Common stock, $0.001 par value: 150,000,000 and 250,000,000 shares authorized at December 31, 2006 and June 30, 2007, respectively; 91,725,528 and 95,901,593 shares issued and outstanding at December 31, 2006 and June 30, 2007, respectively | | | 92 | | | | 96 | |
Additional paid-in capital | | | 709,359 | | | | 772,297 | |
Accumulated other comprehensive loss | | | (25 | ) | | | (7 | ) |
Accumulated deficit | | | (591,624 | ) | | | (604,784 | ) |
| | | | | | | | |
Total stockholders’ equity | | | 117,802 | | | | 167,602 | |
| | | | | | | | |
Total liabilities and stockholders’ equity | | $ | 463,436 | | | $ | 781,639 | |
| | | | | | | | |
###
Page 6 of 6
