-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Vt/x6+xQspvlwLMH4SrvXhCZVWlbZajOHT3/VI5CkOReYKwMtV5N3+c4NAX49GjW Zo/kPxYeTg31e68kSwtKDA== 0001193125-07-173720.txt : 20070807 0001193125-07-173720.hdr.sgml : 20070807 20070807162213 ACCESSION NUMBER: 0001193125-07-173720 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070807 DATE AS OF CHANGE: 20070807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOMARIN PHARMACEUTICAL INC CENTRAL INDEX KEY: 0001048477 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 680397820 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26727 FILM NUMBER: 071031898 BUSINESS ADDRESS: STREET 1: 105 DIGITAL DRIVE CITY: NOVATO STATE: CA ZIP: 94949 BUSINESS PHONE: 4155066700 MAIL ADDRESS: STREET 1: 105 DIGITAL DRIVE CITY: NOVATO STATE: CA ZIP: 94949 8-K 1 d8k.htm FORM 8-K Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 8-K

 


CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 7, 2007

 


BioMarin Pharmaceutical Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware   000-26727   68-0397820

(State or other jurisdiction of

incorporation or organization)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

105 Digital Drive, Novato, California   94949
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (415) 506-6700

 

(Former name or former address, if changed since last report)

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 2.02. Results of Operations and Financial Condition.

On August 7, 2007, BioMarin Pharmaceutical Inc. (the “Company”) announced financial results for its second quarter ended June 30, 2007. The Company’s press release issued on August 7, 2007 is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

  (a) Financial Statements of Business Acquired.

Not Applicable.

 

  (b) Pro Forma Financial Information.

Not Applicable.

 

  (c) Shell Company Transactions.

Not Applicable.

 

  (d) Exhibits.

 

Exhibit 99.1

   Press Release of the Company dated August 7, 2007.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    BioMarin Pharmaceutical Inc., a Delaware corporation
    (Registrant)

Date:    August 7, 2007

   

/s/ G. Eric Davis

    G. Eric Davis
    Vice President, General Counsel


EXHIBIT INDEX

 

Exhibit No.

 

Description

Exhibit 99.1

  Press Release of the Registrant dated August 7, 2007
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

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

 

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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  
                

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