EX-99.1 8 dex991.htm BIOMARIN/GENZYME LLC CONSOLIDATED FINANCIAL STATEMENTS BioMarin/Genzyme LLC Consolidated Financial Statements

Exhibit 99.1

 

BioMarin/Genzyme LLC

 

Index to Consolidated Financial Statements

 

     Page(s)  

Report of Independent Auditors

     1   

Consolidated Balance Sheets as of December 31, 2010 and 2009

     2   

Consolidated Statements of Operations for the Years Ended December 31, 2010, 2009 and 2008 (unaudited)

     3   

Consolidated Statements of Cash Flows for the Years Ended December 31, 2010, 2009 and 2008 (unaudited)

     4   

Consolidated Statements of Changes in Venturers’ Capital for each of the Years Ended December 31, 2008 (unaudited), 2009 and 2010

     5   

Notes to Consolidated Financial Statements

     6 - 9   


Report of Independent Auditors

 

To the Steering Committee of BioMarin/Genzyme LLC:

 

In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations, of cash flows and of changes of venturers’ capital present fairly, in all material respects, the financial position of BioMarin/Genzyme LLC and its subsidiaries (the “Joint Venture”) at December 31, 2010 and December 31, 2009, and the results of their operations and their cash flows for the years ended December 31, 2010 and December 31, 2009 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Joint Venture’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
February 24, 2011

 

1


BioMarin/Genzyme LLC

 

Consolidated Balance Sheets

(Amounts in thousands)

 

     December 31,  
     2010      2009  
ASSETS      

Current assets:

     

Cash and cash equivalents

   $ 3,702       $ 2,088   
                 

Total assets

   $ 3,702       $ 2,088   
                 
LIABILITIES AND VENTURERS’ CAPITAL      

Current liabilities:

     

Due to BioMarin Companies

   $ 147       $ 123   

Due to Genzyme Corporation

     1,338         1,051   

Accrued expenses

     47         —     
                 

Total liabilities

     1,532         1,174   
                 

Commitments and contingencies (Note F)

     —           —     

Venturers’ capital:

     

Venturers’ capital—BioMarin Companies

     1,085         457   

Venturers’ capital—Genzyme Corporation

     1,085         457   
                 

Total Venturers’ capital

     2,170         914   
                 

Total liabilities and Venturers’ capital

   $ 3,702       $ 2,088   
                 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

2


BioMarin/Genzyme LLC

 

Consolidated Statements of Operations

(Amounts in thousands)

 

     For the Years Ended December 31,  
     2010     2009     2008  
                 (unaudited)  

Operating costs and expenses:

      

Selling, general and administrative

     78        —          180   

Research and development

     5,937        5,079        4,452   
                        

Total operating costs and expenses

     6,015        5,079        4,632   
                        

Loss from operations

     (6,015     (5,079     (4,632

Interest income

     7        7        198   
                        

Net Loss

   $ (6,008   $ (5,072   $ (4,434
                        

Net Loss attributable to each Venturer:

      

BioMarin Companies

   $ (3,004   $ (2,536   $ (2,217
                        

Genzyme Corporation

   $ (3,004   $ (2,536   $ (2,217
                        

 

The accompanying notes are an integral part of these consolidated financial statements.

 

3


BioMarin/Genzyme LLC

 

Consolidated Statements of Cash Flows

(Amounts in thousands)

 

     For the Years Ended December 31,  
     2010     2009     2008  
                 (unaudited)  

Cash Flows from Operating Activities:

      

Net Loss

   $ (6,008   $ (5,072   $ (4,434

Reconciliation of net loss to net cash used in operating activities:

      

Charge for impaired assets

     —          —          138   

Increase (decrease) in cash from working capital changes:

      

Prepaid expenses and other current assets

     —          —          42   

Due from (to) BioMarin Companies

     24        (134     257   

Due from (to) Genzyme Corporation

     287        63        988   

Accrued expenses

     47        —          —     
                        

Cash flows used in operating activities

     (5,650     (5,143     (3,009

Cash Flows from Financing Activities:

      

Capital distribution to BioMarin Companies

     —          —          (18,770

Capital distribution to Genzyme Corporation

     —          —          (6,595

Capital contribution from BioMarin Companies

     3,632        2,120        1,750   

Capital contribution from Genzyme Corporation

     3,632        2,120        1,750   
                        

Cash flows provided by (used in) financing activities

     7,264        4,240        (21,865
                        

Increase (decrease) in cash and cash equivalents

     1,614        (903     (24,874

Cash and cash equivalents at beginning of period

     2,088        2,991        27,865   
                        

Cash and cash equivalents at end of period

   $ 3,702      $ 2,088      $ 2,991   
                        

 

The accompanying notes are an integral part of these consolidated financial statements.

 

4


BioMarin/Genzyme LLC

 

Consolidated Statements of Changes in Venturers’ Capital

(Amounts in thousands)

 

     Venturers’ Capital     Total
Venturers’
Capital
 
     BioMarin
Companies
    Genzyme
Corporation
   

Balance at December 31, 2007

   $ 45,005      $ 45,004      $ 90,009   

2008 capital distributions (unaudited)

     (43,665     (43,664     (87,329

2008 capital contributions (unaudited)

     1,750        1,750        3,500   

2008 net loss (unaudited)

     (2,217     (2,217     (4,434
                        

Balance at December 31, 2008 (unaudited)

     873        873        1,746   

2009 capital contributions

     2,120        2,120        4,240   

2009 net loss

     (2,536     (2,536     (5,072
                        

Balance at December 31, 2009

     457        457        914   

2010 capital contributions

     3,632        3,632        7,264   

2010 net loss

     (3,004     (3,004     (6,008
                        

Balance at December 31, 2010

   $ 1,085      $ 1,085      $ 2,170   
                        

 

The accompanying notes are an integral part of these consolidated financial statements.

 

5


BioMarin/Genzyme LLC

 

Notes to Consolidated Financial Statements

 

A. Nature of Business and Organization

 

BioMarin/Genzyme LLC, or the Joint Venture, is a limited liability company organized under the laws of the State of Delaware. The Joint Venture is owned:

 

   

50% by BioMarin Pharmaceutical Inc., which is referred to as BioMarin, and BioMarin Genetics, Inc., a wholly-owned subsidiary of BioMarin. BioMarin and its subsidiary are referred to as the BioMarin Companies; and

 

   

50% by Genzyme Corporation, which is referred to as Genzyme.

 

The BioMarin Companies and Genzyme are collectively referred to as the Venturers and individually as a Venturer. The Joint Venture was organized in September 1998 to develop and commercialize Aldurazyme®, a recombinant form of the human enzyme alpha-L-iduronidase, used to treat a lysosomal storage disorder known as mucopolysaccharidosis I, or MPS I. The Joint Venture commenced operations as of September 4, 1998.

 

The Joint Venture, BioMarin Companies and Genzyme entered into a Collaboration Agreement dated as of September 4, 1998. Under the terms of the Collaboration Agreement, Genzyme and the BioMarin Companies granted to the Joint Venture a world-wide, exclusive, irrevocable, royalty-free right and license or sublicense to develop, manufacture and market Aldurazyme for the treatment of MPS I and other alpha-L-iduronidase deficiencies. All program-related costs are equally funded by BioMarin, on behalf of the BioMarin Companies, and Genzyme. BioMarin and Genzyme are required to make monthly capital contributions to the Joint Venture to fund budgeted operating costs, as necessary. If either BioMarin or Genzyme fails to make two or more of the monthly capital contributions, and the other party does not exercise its right to terminate the Collaboration Agreement or compel performance of the funding obligation, the defaulting party’s (or, in the case of default by BioMarin, the BioMarin Companies’) percentage interest in the Joint Venture and future funding responsibility will be adjusted proportionately. In 2010, both Venturers contributed $3.6 million and in 2009, both Venturers contributed $2.1 million and in 2008 (unaudited), both Venturers contributed $1.8 million to the Joint Venture.

 

The Steering Committee of the Joint Venture serves as the governing body of the Joint Venture and is responsible for determining the overall strategy for the program, coordinating activities of the Venturers as well as performing other such functions as appropriate. The Steering Committee is comprised of an equal number of representatives of each Venturer.

 

On April 30, 2003, the United States Food and Drug Administration, commonly referred to as the FDA, granted marketing approval for Aldurazyme as an enzyme replacement therapy for patients with the Hurler and Hurler-Scheie forms of MPS I, and Scheie patients with moderate to severe symptoms. Aldurazyme has been granted orphan drug status in the United States, which generally provides seven years of market exclusivity. On June 11, 2003, the European Commission granted marketing approval for Aldurazyme to treat the non-neurological manifestations of MPS I in patients with a confirmed diagnosis of the disease. Aldurazyme has been granted orphan drug status in the European Union, which generally provides ten years of market exclusivity. In October 2006, Japan’s Health, Labor and Welfare Ministry granted marketing approval for Aldurazyme, the first specific treatment approved in Japan for patients with MPS I. Aldurazyme has been granted orphan drug status in Japan, which generally provides ten years of market exclusivity. To date, Aldurazyme has received marketing approval in over fifty countries. Aldurazyme is sold directly to physicians, hospitals, treatment centers, pharmacies and government agencies through a specalized sales force, as well as through distributors or wholesalers.

 

On January 1, 2008, the BioMarin Companies and Genzyme restructured the Joint Venture. Instead of sharing all costs and profits equally, Genzyme will record sales of Aldurazyme and will pay BioMarin a tiered

 

6


BioMarin/Genzyme LLC

 

Notes to Consolidated Financial Statements (Continued)

 

A. Nature of Business and Organization (Continued)

 

payment ranging from approximately 39.5% to 50% of worldwide net product sales, which will be recorded by BioMarin as product revenue. Certain research and development activities related to Aldurazyme and intellectual property will continue to be managed by the Joint Venture on an equal basis.

 

B. Summary of Significant Accounting Policies

 

Basis of Presentation

 

The consolidated financial statements have been prepared under the accrual method of accounting in conformity with accounting principles generally accepted in the United States of America.

 

The Joint Venture is considered a partnership for federal and state income tax purposes. As such, items of income, loss, deductions and credits flow through to the Venturers. The Venturers have responsibility for the payment of any income taxes on their proportionate share of the taxable income of the Joint Venture.

 

The consolidated financial statements for the years ended December 31, 2009 and December 31, 2010 have been audited. The financial statements for the year ended December 31, 2008 are unaudited, and reflect all adjustments (consisting of normal recurring accruals) which are, in management’s opinion, necessary to present a fair statement of results for the year ended December 31, 2008.

 

Basis of Consolidation

 

The accompanying consolidated financial statements include the accounts of the Joint Venture and its subsidiaries. All inter-company accounts and transactions have been eliminated.

 

Fiscal Year End

 

The Venturers have determined that the fiscal year end of the Joint Venture is December 31.

 

Use of Estimates

 

Under accounting principles generally accepted in the United States of America, the Joint Venture is required to make certain estimates and assumptions that affect reported amounts of assets, liabilities, revenues, expenses, and disclosure of contingent assets and liabilities in its consolidated financial statements. The Joint Venture’s actual results could differ from these estimates.

 

Cash and Cash Equivalents

 

Cash and cash equivalents, consisting principally of money market funds with initial maturities of three months or less, are valued at cost plus accrued interest, which the Joint Venture believes approximates their fair market value. Money market funds are typically classified as Level 1 investments as these products do not require a significant degree of judgment. All of the Joint Venture’s cash is held on deposit at one financial institution.

 

Comprehensive Income

 

The Joint Venture reports comprehensive income in accordance with Financial Accounting Standards Board Accounting Standards Codification, or ASC, 220, “Comprehensive Income.” Comprehensive income for the years ended December 31, 2010, 2009 and 2008 does not differ from the reported net income.

 

7


BioMarin/Genzyme LLC

 

Notes to Consolidated Financial Statements (Continued)

 

B. Summary of Significant Accounting Policies (Continued)

 

Transactions with Affiliates

 

The majority of the Joint Venture’s operating expenses consist of project expenses incurred by the Venturers, either for internal operating costs or for third-party obligations incurred by the Venturers on behalf of the Joint Venture which are then charged to the Joint Venture. All charges to the Joint Venture are subject to approval by the Steering Committee. The determination of the amount of internal operating costs incurred by each Venturer on behalf of the Joint Venture requires significant judgment by each Venturer. As a result, the consolidated financial statements for the Joint Venture may not be indicative of the results that would have occurred had the Joint Venture obtained all of its manufacturing, commercialization and research and development services from unrelated third-party entities. The Joint Venture owed Genzyme Corporation $1.3 million at December 31, 2010 and $1.1 million at December 31, 2009 for project expenses incurred on behalf of the Joint Venture. The Joint Venture owed BioMarin Companies $0.1 million at December 31, 2010 and $0.1 million at December 31, 2009 for project expenses incurred on behalf of the Joint Venture.

 

Translation of Foreign Currencies

 

In 2008, 2009 and 2010 all expenses incurred on behalf of the Joint Venture were in U.S. dollars and no foreign currency transaction gains or losses were incurred.

 

Research and Development

 

Research and development costs are expensed in the period incurred. These costs are primarily comprised of development efforts performed by the Venturers or payments to third parties made by the Venturers, both on behalf of the Joint Venture, during the respective periods.

 

Income Taxes

 

The Joint Venture is organized as a pass-through entity and accordingly, the consolidated financial statements do not include a provision for income taxes. Taxes, if any, are the liability of the BioMarin Companies and Genzyme, as Venturers.

 

C. Technology License Fees

 

In 2005, the Joint Venture paid $0.4 million for technology license fees. In 2008, as a result of the restructuring, the license fees which had a book value of $138,000 were written off.

 

D. Venturers’ Capital

 

Venturers’ capital is comprised of capital contributions made by the Venturers to fund expenses of the Joint Venture in accordance with the Collaboration Agreement, and income (losses) allocated to the Venturers, net of cash distributions to the Venturers. All funding is shared equally by the two Venturers. As of December 31, 2010, the BioMarin Companies and Genzyme have each provided a total of $74.8 million of funding to the Joint Venture, net of $39.9 million of cash distributed by the Joint Venture to each Venturer.

 

On January 1, 2008 as part of the restructuring, the Joint Venture distributed the majority of its net assets to the Venturers. The BioMarin Companies received $24.9 million in non-cash assets and $18.8 million in cash. Genzyme received $37.1 million in non-cash assets and $6.6 million in cash. In 2008, 2009 and 2010, each Venturer contributed $1.8 million (unaudited), $2.1 million and $3.6 million respectively, to cover the operating expenses.

 

8


BioMarin/Genzyme LLC

 

Notes to Consolidated Financial Statements (Continued)

 

E. Commitments and Contingencies

 

Legal Proceedings

 

Under the Joint Venture’s Operating Agreement, the Joint Venture indemnifies its affiliates for acts performed under the agreement on behalf of the Joint Venture, including amounts paid by affiliates in connection with legal proceedings related to the Joint Venture or its operations.

 

There have been several lawsuits filed in Brazil alleging that an affiliate of a member of the Joint Venture is contractually obligated to provide drugs at no cost to several patients. The affiliate is vigorously defending against these actions. Management of the Joint Venture is not able to predict the outcome of these cases or estimate with certainty the amount or range of any possible loss the Joint Venture might incur if the affiliate does not prevail in the final, non-appealable determination of any or all of these matters and the Joint Venture has to indemnify the affiliate for amounts paid related to settlement of any of these lawsuits.

 

The Joint Venture periodically becomes subject to legal proceedings and claims arising in connection with its business. The Joint Venture is not able to predict the outcome of any legal proceedings, to which it may become subject in the normal course of business, or estimate the amount or range of any reasonably possible loss the Joint Venture might incur if it does not prevail in the final, non-appealable determinations of such matters. Therefore, the Joint Venture has no current accruals for these potential contingencies. The Joint Venture can provide no assurance that legal proceedings will not have a material adverse impact on its financial condition or results of operations.

 

F. Subsequent Events

 

The Joint Venture has performed an evaluation of subsequent events through February 24, 2011, which is the date the financial statements were issued.

 

9