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BioMarin Announces First Quarter 2006 Financial Results2006 Naglazyme Sales Guidance Increased and 2006 Net Loss Guidance Improved
NOVATO, Calif., May 3 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced results for its first quarter ended March 31, 2006. The net loss was $9.8 million ($0.13 per share) for the first quarter of 2006, compared to $22.5 million ($0.35 per share) for the first quarter of 2005. Total stock compensation costs during the first quarter of 2006 were $2.1 million, of which $1.7 million ($0.02 per share) was included in the net loss and $0.4 million was capitalized into inventory. "I am pleased with what we have accomplished in the first quarter of the year, especially the progress we have made with the commercial launch of Naglazyme," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "In the coming months, we look forward to initiating a Phase 2 clinical trial of 6R-BH4 for poorly controlled hypertension, a product opportunity that, if proven to be safe and effective, could provide BioMarin the opportunity to address an unmet medical need faced by a significant number of adults." Net sales of Naglazyme(TM) (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), for the first quarter of 2006 were $7.0 million. 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 currently commercializing Naglazyme in the United States and Europe. Net sales of Aldurazyme(R) (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I, (MPS I) by BioMarin/Genzyme LLC were $21.3 million for the first quarter of 2006, compared to $15.9 million for the same period of 2005, representing an increase of 34 percent. BioMarin's share of the profit of BioMarin/Genzyme LLC was $3.8 million for the first quarter of 2006, compared to $2.1 million for the first quarter of 2005. Net sales of Orapred(R) (prednisolone sodium phosphate oral solution), including the branded and authorized generic products, were $2.0 million for the first quarter of 2006, compared to $5.0 million for the first quarter of 2005. Royalties and license revenues for the first quarter of 2006 were $0.3 million and includes the amortization of the $2.5 million up-front license payment received from Alliant Pharmaceuticals, pursuant to the licensing and acquisition agreement entered into on March 15, 2006, and royalties on subsequent sales of Orapred. In accordance with the agreement, BioMarin will receive milestone payments primarily based on approval and launch of Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets) and royalties on sales from the Orapred product line. As of March 31, 2006, BioMarin had cash, cash equivalents and short-term investments of approximately $347.7 million. 2006 Projected Net Product Sales BioMarin has revised its previously estimated sales of Naglazyme for the fiscal year ending December 31, 2006 to be in a range of $31 million to $34 million, increased from a previously estimated range of $28 million to $32 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 lowered its estimated GAAP net loss for the fiscal year ending December 31, 2006 from a range of $49 million to $52 million to a range of $42 million to $45 million, which includes $8.7 million of expenses related to the 2004 acquisition of Orapred and $7.5 million of expenses related to stock option compensation. This guidance also reflects $14 million in milestone revenue, which is contingent upon the anticipated approval and launch of Orapred ODT in 2006. Recent Events and First Quarter 2006 Highlights
-- On January 10, 2006, BioMarin announced that it had established
operations for BioMarin Europe Ltd., positioning the company to launch
Naglazyme in the European Union and to partner with companies looking
to bring other products for rare diseases to the European marketplace.
-- On March 15, 2006, BioMarin and Serono (virt-x: SEO and NYSE: SRA)
announced positive results from a Phase 3 clinical study of
Phenoptin(TM) (sapropterin dihydrochloride) for the treatment of
phenylketonuria (PKU). All primary and secondary endpoints of the
study were met. Phenoptin was well tolerated and the type and
incidence of adverse events was similar in the Phenoptin and placebo
groups. Phenoptin has been designated an orphan drug in the United
States and Europe and Fast Track status in the United States.
-- On March 15, 2006, BioMarin and Alliant Pharmaceuticals announced the
formation of a licensing and acquisition agreement pertaining to
exclusive North American rights to the Orapred product line. Pursuant
to the agreement, Alliant will pay BioMarin a total of $18 million in
milestone payments, contingent primarily on the approval and launch of
Orapred ODT in the United States, and royalties on net product sales of
the Orapred product line.
-- On March 30, 2006, BioMarin announced the closing of a $295 million
concurrent public offering of common stock and senior convertible
notes.
-- On April 17, 2006, BioMarin extinguished its $19.9 million facility and
equipment loan with Comerica Bank, using proceeds from its March public
offering.
-- On April 18, 2006, BioMarin completed the purchase of its manufacturing
facility located at 46 Galli Drive, Novato, California, for a purchase
price of $17.0 million. Because of the amount raised in its March
public offering and the proposed terms of loans for the facility,
BioMarin elected to pay cash for the purchase.
-- On April 20, 2006, the last patient was enrolled in the 22-week Phase 3
extension study of Phenoptin for PKU.
Upcoming Company Milestones
BioMarin expects to continue to advance its clinical-stage product candidates in the coming months. The following is a list of the company's projected near-term milestones: -- initiate a Phase 2 clinical study of 6R-BH4 in poorly controlled
hypertension in the second quarter of 2006 and a Phase 2 clinical study
of 6R-BH4 in peripheral arterial disease and/or erectile dysfunction in
the fourth quarter of 2006;
-- announce the outcome of the FDA's review of the New Drug Application
for Orapred ODT for the treatment of inflammatory conditions as,
pursuant to the Prescription Drug User Fee Act (PDUFA), the FDA is
required to take action by June 1, 2006;
-- present results from the Phase 3 clinical study of Phenoptin for PKU at
genetic conferences being held in the fall, including: The 10th
International Congress on Inborn Errors of Metabolism (ICIEM), being
held in Chiba, Japan, September 12 to 16, and an associated meeting
entitled, "Tetrahydrobiopterin and Alternative Treatments for
Phenylketonuria, Cardiovascular Diseases and Diabetes," being held
September 10 to 11 in Sendai, Japan; a workshop at the 2006 Annual
Meeting of the American Society of Human Genetics (ASHG) being held in
New Orleans, Louisiana, October 10 to 14; and
-- support two physician-sponsored clinical studies of 6R-BH4, one in
pulmonary arterial hypertension and the other in endothelial
dysfunction in patients with coronary artery disease, both targeted to
begin in the second half of 2006.
Conference Call and Webcast Scheduled for Today, May 3 at 5:00 p.m. EDT
BioMarin will host a conference call and webcast to discuss first quarter 2006 financial results on Wednesday, May 3, at 5:00 p.m. EDT (23:00 CEST). This event can be accessed on the investor section of the BioMarin website at http://www.bmrn.com/. Date: May 3, 2006 Time: 5:00 p.m. EDT (23:00 CEST) U.S. & Canada Toll-free Dial in #: 800-798-2801 International Dial in #: 617-614-6205 Participant Code: 40714117 Replay Toll-free Dial in #: 888-286-8010 Replay International Dial in #: 617-801-6888 Replay Code: 28412863 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. Additionally, BioMarin has rights to receive payments and royalties related to Orapred(R). (prednisolone sodium phosphate oral solution) Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU). 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; the financial performance of BioMarin as a whole; the continued partial funding of the Phenoptin program by Serono; the timing of BioMarin's clinical trials of Phenoptin and 6R-BH4; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Orapred, Phenoptin and 6R-BH4; 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: BioMarin's success in continuing commercialization of Naglazyme; BioMarin's 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 and Naglazyme; actual sales of Aldurazyme, Naglazyme and Orapred; actions by Serono as permitted under BioMarin's license to it; the effect of the recent requirement to expense stock-based compensation; 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" BioMarin's 2005 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. Investors
Joshua A. Grass
Director, Business Development & Finance
BioMarin Pharmaceutical Inc.
415-506-6777
Media
Susan Ferris
Senior Manager, Corporate Communications
BioMarin Pharmaceutical Inc.
415-506-6701
BioMarin Pharmaceutical Inc. and Subsidiaries
Net Product Sales
For the Three Months Ended March 31, 2005 and 2006
(In thousands, unaudited)
Three Months Ended
March 31,
2005 2006
Aldurazyme (as reported by
BioMarin/Genzyme LLC) (1) $15,874 $21,332
Naglazyme -- 7,022
Orapred 4,989 1,957
(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 Months Ended, March 31, 2005 and 2006
(In thousands, except for per share data, unaudited)
Three Months Ended
March 31,
2005 2006
Net product sales $4,989 $8,979
Collaborative agreement revenues -- 4,514
Royalty and license revenues -- 319
Total revenues 4,989 13,812
Operating expenses:
Cost of sales (excludes
amortization of developed
product technology) 660 1,722
Research and development 14,992 12,279
Selling, general and administrative 10,567 10,896
Amortization of acquired intangible
assets 286 373
Total operating expenses 26,505 25,270
Equity in the income of
BioMarin/Genzyme LLC 2,076 3,800
Loss from operations (19,440) (7,658)
Interest income 241 699
Interest expense (3,259) (2,821)
Net loss $(22,458) $(9,780)
Net loss per share, basic and diluted $(0.35) $(0.13)
Weighted average common shares
outstanding, basic and diluted 64,511 74,963
BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except for share and per share data)
December 31, March 31,
2005 (1) 2006
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $38,092 $341,689
Short-term investments 9,700 6,000
Accounts receivable, net 5,860 7,493
Advances to BioMarin/Genzyme LLC 1,071 653
Inventory 10,898 18,137
Other current assets 3,320 4,787
Total current assets 68,941 378,759
Cash balances related to long-term debt 17,049 --
Investment in BioMarin/Genzyme LLC 31,983 27,783
Property and equipment, net 37,321 36,251
Acquired intangible assets, net 15,306 14,934
Goodwill 21,262 21,262
Other assets 3,441 9,240
Total assets $195,303 $488,229
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable and accrued
liabilities $20,934 $19,946
Current portion of acquisition
obligation, net of discount 7,477 7,104
Current portion of deferred revenue 8,096 9,893
Current portion of equipment and
facility loans 3,860 19,944
Total current liabilities 40,367 56,887
Convertible debt 125,000 297,500
Long-term portion of acquisition
obligation, net of discount 70,873 70,336
Deferred revenue, net of current portion 11,825 9,908
Equipment and facility loan, net of
current portion 17,049 --
Other long-term liabilities 7,651 7,593
Total liabilities 272,765 442,224
Stockholders' equity (deficit):
Common stock, $0.001 par
value: 150,000,000 shares
authorized; 74,301,610 and
85,171,044 shares issued and
outstanding at December 31, 2005
and March 31, 2006, respectively 75 85
Additional paid-in capital 485,570 618,806
Accumulated other comprehensive loss (16) (15)
Accumulated deficit (563,091) (572,871)
Total stockholders' equity (deficit) (77,462) 46,005
Total liabilities and stockholders'
equity (deficit) $195,303 $488,229
(1) December 31, 2005 balances were derived from the audited consolidated financial statements. Website: http://www.bmrn.com/ |
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