-----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, I1wg+72qe6Rhg1jdAy6l3SYs0Ojpoh0UlwLbZ1IKMqPP9VmjO0sdx1RNF2OmhrAF 7F+9Jprb0wQMIZLnDfnsbA== 0001193125-07-034773.txt : 20070220 0001193125-07-034773.hdr.sgml : 20070219 20070220101944 ACCESSION NUMBER: 0001193125-07-034773 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070220 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070220 DATE AS OF CHANGE: 20070220 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: 07633937 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): February 20, 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 February 20, 2007, BioMarin Pharmaceutical Inc. (the “Company”) announced financial results for its fourth quarter and year ended December 31, 2006. The Company’s press release issued on February 20, 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 February 20, 2007.

 

-2-


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   February 20, 2007  

/s/ G. Eric Davis

   

G. Eric Davis

Vice President, General Counsel

 

-3-


EXHIBIT INDEX

 

Exhibit No.   

Description

Exhibit 99.1    Press Release of the Registrant dated February 20, 2007

 

-4-

EX-99.1 2 dex991.htm PRESS RELEASE OF THE REGISTRANT DATED FEBRUARY 20, 2007 Press Release of the Registrant dated February 20, 2007

Exhibit 99.1

LOGO

Contact:

Investors and Media

Eugenia Shen

BioMarin Pharmaceutical Inc.

(415) 506-6570

For Immediate Release:

BioMarin Announces Fourth Quarter and Full Year 2006 Financial Results

Positive Outlook for 2007 Driven by Increasing Revenue

and Advancing Product Pipeline

Conference Call and Webcast to Be Held Today at 11:00 a.m. ET (17:00 CET)

Novato, Calif., February 20, 2007 – BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) today announced financial results for its fourth quarter and year ended December 31, 2006. The net loss was $10.4 million ($0.11 per share) for the fourth quarter of 2006, compared to a net loss of $15.0 million ($0.20 per share) for the fourth quarter of 2005. The net loss for the year ended December 31, 2006 was $28.5 million ($0.34 per share), compared to a net loss of $74.3 million ($1.08 per share) for the year ended December 31, 2005, representing a reduction of $45.8 million, or approximately 61.6 percent.

As of December 31, 2006, BioMarin had cash, cash equivalents, and short-term investments totaling $288.8 million.

Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin commented, “In 2006, we continued to improve our financial profile by increasing product revenue, reducing the net loss, and strengthening the balance sheet. We also advanced our product pipeline by completing the Phenoptin Phase 3 clinical trials with very positive results and making significant progress in the pre-clinical development of Phenylase for PKU. Looking ahead in 2007, we expect continuing growth of Naglazyme and Aldurazyme sales to substantially offset research and development spending for ongoing clinical programs. In addition, we are hopeful that Phenoptin will be approved by the FDA as the first treatment option for PKU patients by the end of the year.”

Product Sales

Net sales of Naglazyme® (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), were $16.3 million for the fourth quarter of 2006, compared to $12.9 million for the third quarter of 2006, representing a sequential increase of approximately 26.4 percent. Naglazyme net sales were $46.5 million for the year ended December 31, 2006. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) in late May 2005, and by the European Commission in late January 2006. Naglazyme net sales for the three months and year ended December 31, 2005 were $3.7 million and $6.1 million, respectively. 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 25.0 percent to $26.5 million for the fourth quarter of 2006, compared to $21.2 million in the fourth quarter of 2005. Net sales for the year ended December 31, 2006 increased by approximately 26.0 percent to $96.3 million, compared to $76.4 million for the year ended December 31, 2005. BioMarin’s share of the profit of BioMarin/Genzyme LLC was $5.7 million for the fourth quarter of 2006, compared to a profit of $3.1 million for the fourth quarter of 2005. BioMarin’s share of the profit from BioMarin/Genzyme LLC for the year ended December 31, 2006 was $19.3 million, compared to $11.8 million for the year ended December 31, 2005.

 

Page 1 of 6


Royalty and License Revenues

Royalty and license revenues for the fourth quarter and full year 2006 were $0.8 million and $15.9 million, respectively, 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). BioMarin expects to receive an additional milestone payment of $4.0 million on the first anniversary of FDA approval of Orapred ODT in June 2007.

Financial Guidance

2007 Projected Net Product Sales

BioMarin estimates 2007 net sales of Naglazyme to be in the range of $74 million to $78 million and sales of Aldurazyme by the joint venture for 2007 to be in a range of $115 million to $125 million.

2007 Projected Net Loss

BioMarin estimates its GAAP net loss for the fiscal year ending December 31, 2007 to be in the range of $20 million to $25 million, which includes approximately $16 million to $18 million in non-cash stock compensation expense.

Recent Events and Fourth Quarter 2006 Highlights

 

- On January 29, BioMarin announced that the remaining $51.4 million of convertible notes due 2008 was converted into common stock.

 

- On January 16, BioMarin announced positive results from the Phase 3 diet study of Phenoptin for PKU.

 

- On January 4, BioMarin announced the initiation of the Phase 2 clinical study of 6R-BH4 in peripheral arterial disease.

 

- On December 18, BioMarin announced positive results from the Phase 3 extension study of Phenoptin for PKU.

BioMarin will host a conference call and webcast to discuss fourth quarter and full year 2006 financial results today, Tuesday, February 20, at 11:00 a.m. ET (23:00 CET). This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.

Date: February 20, 2007

Time: 11:00 a.m. ET (17:00 CET)

U.S. & Canada Toll-free Dial in #: 800.901.5217

International Dial in #: 617.786.2964

Participant Code: 35915200

Replay Toll-free Dial in #: 888.286.8010

Replay International Dial in #: 617.801.6888

Replay Code: 94899251

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

 

Page 2 of 6


Phenoptin™ (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 and 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; 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; actions by regulatory authorities, including actions related to Naglazyme, Phenoptin, and 6R-BH4 for other indications; and expectations regarding actions by Merck Serono related to filing the marketing authorization application for 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: 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; 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 Phenoptin; 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.

Naglazyme® is a registered trademark 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 Months and Years Ended December 31, 2005 and 2006

(In millions, unaudited)

 

    

Three Months Ended

December 31,

  

Year Ended

December 31,

   2005    2006    2005    2006

Aldurazyme (as reported by BioMarin/Genzyme LLC) (1)

   $ 21.2    $ 26.5    $ 76.4    $ 96.3

Naglazyme

     3.7      16.3      6.1      46.5

Orapred (2)

     0.4      —        6.9      3.1

(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) Effective with the sublicense of the Orapred North American rights in March 2006, BioMarin no longer reports net sales of Orapred. Orapred royalty revenue is included in Royalty and License Revenues on the consolidated statements of operations.

 

Page 4 of 6


BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three Months and Years Ended, December 31, 2005 and 2006

(In thousands, except for per share data, unaudited)

 

    

Three Months Ended

December 31,

   

Year Ended

December 31,

 
     2005     2006     2005     2006  

Revenues:

        

Net product sales

   $ 4,157     $ 16,310     $ 13,039     $ 49,606  

Collaborative agreement revenues

     5,317       4,882       12,630       18,740  

Royalty and license revenues

     —         827       —         15,863  
                                

Total revenues

     9,474       22,019       25,669       84,209  
                                

Operating expenses:

        

Cost of sales (excludes amortization of developed product technology)

     1,327       3,616       2,629       8,740  

Research and development

     12,682       20,572       56,391       66,735  

Selling, general and administrative

     11,076       13,971       41,556       49,030  

Amortization of acquired intangible assets

     286       1,093       1,144       3,651  
                                

Total operating expenses

     25,371       35,636       101,720       128,156  
                                

Equity in the income of BioMarin/Genzyme LLC

     3,072       5,670       11,838       19,274  
                                

Loss from operations

     (12,825 )     (11,563 )     (64,213 )     (24,673. )

Interest income

     685       4,129       1,861       12,866  

Interest expense

     (2,856 )     (2,957 )     (11,918 )     (16,726 )
                                

Net loss

   $ (14,996 )   $ (10,391 )   $ (74,270 )   $ (28,533 )
                                

Net loss per share, basic and diluted

   $ (0.20 )   $ (0.11 )   $ (1.08 )   $ (0.34 )
                                

Weighted average common shares outstanding, basic and diluted

     74,048       91,552       68,830       84,582  
                                

 

Page 5 of 6


BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

December 31, 2005 and 2006

(In thousands, except for share and per share data)

 

     2005     2006  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 38,092     $ 89,162  

Short-term investments

     9,700       199,685  

Accounts receivable, net

     5,860       14,670  

Advances to BioMarin/Genzyme LLC

     1,071       1,596  

Inventory

     10,898       25,075  

Other current assets

     3,320       4,036  
                

Total current assets

     68,941       334,224  

Cash balances related to long-term debt

     17,049       —    

Investment in BioMarin/Genzyme LLC

     31,983       31,457  

Property, plant and equipment, net

     37,321       55,466  

Acquired intangible assets, net

     15,306       11,655  

Goodwill

     21,262       21,262  

Other assets

     3,441       9,372  
                

Total assets

   $ 195,303     $ 463,436  
                

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

    

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 20,934     $ 32,166  

Current portion of acquisition obligation, net of discount

     7,477       6,787  

Current portion of deferred revenue

     8,096       7,092  

Current portion of equipment and facility loans

     3,860       —    
                

Total current liabilities

     40,367       46,045  

Convertible debt

     125,000       223,940  

Long-term portion of acquisition obligation, net of discount

     70,873       68,548  

Deferred revenue, net of current portion

     11,825       5,023  

Equipment and facility loan, net of current portion

     17,049       —    

Other long-term liabilities

     7,651       2,078  
                

Total liabilities

    
                

Stockholders’ equity (deficit):

    

Common stock, $0.001 par value: 150,000,000 shares authorized; 74,301,610 and 91,725,528 shares issued and outstanding at December 31, 2005 and December 31, 2006, respectively

     75       92  

Additional paid-in capital

     485,570       709,359  

Accumulated other comprehensive loss

     (16 )     (25 )

Accumulated deficit

     (563,091 )     (591,624 )
                

Total stockholders’ equity (deficit)

     (77,462 )     117,802  
                

Total liabilities and stockholders’ equity (deficit)Total liabilities and stockholders’ equity (deficit)

   $ 195,303     $ 463,436  
                

###

 

Page 6 of 6

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