EX-99.1 2 dex991.htm PRESS RELEASE OF THE COMPANY DATED FEBRUARY 18, 2009 Press Release of the Company dated February 18, 2009

Exhibit 99.1

LOGO

Contact:

 

Investors

   Media

Eugenia Shen

   Susan Berg

BioMarin Pharmaceutical Inc.

   BioMarin Pharmaceutical Inc.

(415) 506-6570

   (415) 506-6594

For Immediate Release:

BioMarin Announces Fourth Quarter and Full Year 2008 Financial Results

2008 First Profitable Full Year

Conference Call and Webcast to Be Held Today at 5:00 p.m. ET (22:00 CET)

Financial Highlights ($ in millions, except per share data)

 

Item

  

FY 2008

  

FY 2007 Comparison

Total BioMarin Revenue

   $296.5    143.9% increase

Naglazyme Net Product Revenue

   $132.7    53.9% increase

Aldurazyme Net Sales by Genzyme

   $151.3    22.3% increase

Aldurazyme BioMarin Net Product Revenue

   $72.5    NA

Kuvan Net Product Revenue

   $46.7    $0.4

GAAP Net Income (Loss)

   $30.8    ($15.8)

GAAP Net Income (Loss) per share

   $0.31 (basic), $0.29 (diluted)    ($0.16) (basic and diluted)

Non-GAAP Net Income (Loss)

   $56.1    $2.5

Non-GAAP Net Income (Loss) per share

   $0.57 (basic), $0.52 (diluted)    $0.03 (basic and diluted)

Novato, Calif., February 18, 2009 – BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced financial results for the fourth quarter and year ended December 31, 2008. Net income was $24.5 million ($0.21 per fully diluted share) for the fourth quarter of 2008, compared to net income of $2.6 million ($0.03 per fully diluted share) for the fourth quarter of 2007. Non-GAAP net income was $31.9 million ($0.27 per fully diluted share) for the fourth quarter of 2008, compared to non-GAAP net income of $8.1 million ($0.08 per fully diluted share) for the fourth quarter of 2007. Non-GAAP net income/loss excludes non-cash stock compensation expense, which was $7.4 million for the three months ended December 31, 2008 and $5.5 million for the three months ended December 31, 2007.

Net income for the year ended December 31, 2008 was $30.8 million ($0.29 per fully diluted share), compared to a net loss of $15.8 million ($0.16 per fully diluted share) for the year ended December 31, 2007. Non-GAAP net income was $56.1 million ($0.52 per fully diluted share) for the year ended December 31, 2008, compared to non-GAAP net income of $2.5 million ($0.03 per fully diluted share) for the year ended December 31, 2007. Non-cash stock compensation expense for the year ended December 31, 2008 and December 31, 2007 was $25.3 million and $18.3 million, respectively.

As of December 31, 2008, BioMarin had cash, cash equivalents, and short-term investments totaling $559.8 million.

“We achieved our first profitable full year in 2008, with an increase of 144 percent in total revenue over 2007 driven by our three growing commercial products. We ended the year with a strong cash position and a promising development pipeline,” said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. “In 2009, we look forward to the advancement of several programs including PEG-PAL for PKU and GALNS for MPS IVA. We also plan to continue making investments in growth opportunities as we look for attractive in-licensing or acquisition opportunities.”

 

Page 1 of 7


Net Product Revenue

Net product revenue from Naglazyme (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), was $36.5 million for the fourth quarter of 2008, an increase of 43.1 percent compared to Naglazyme net product revenue of $25.5 million for the fourth quarter of 2007. Net product revenue from Naglazyme for the year ended December 31, 2008 was $132.7 million, an increase of 53.9 percent from Naglazyme net product revenue of $86.2 million for the year ended December 31, 2007.

Net sales of Aldurazyme (laronidase), an enzyme replacement therapy for mucopolysaccharidosis I (MPS I) recorded by Genzyme, were $37.6 million for the fourth quarter of 2008, an increase of 6.2 percent compared to net sales by Genzyme of $35.4 million for the fourth quarter of 2007. Net sales of Aldurazyme recorded by Genzyme for the year ended December 31, 2008 were $151.3 million, an increase of 22.3 percent compared to net sales by Genzyme of $123.7 million for the year ended December 31, 2007.

Net product revenue to BioMarin related to Aldurazyme was $14.4 million for the fourth quarter of 2008. This reflects a reduction in net product revenue from the royalty payable to BioMarin by Genzyme due to the timing of inventory transfers to Genzyme, which were less than units shipped to third party customers by Genzyme during the fourth quarter of 2008. Net product revenue to BioMarin related to Aldurazyme was $72.5 million for the year ended December 31, 2008, which included $12.4 million of net incremental product transfer revenue during 2008.

Beginning January 1, 2008, as a result of the restructuring of the joint venture with Genzyme, BioMarin receives a royalty of 39.5% to 50% of worldwide net sales. BioMarin recognizes a portion of this amount as product transfer revenue when product is released to Genzyme. This amount will eventually be credited against the calculated royalties earned when the product is sold by Genzyme to third parties.

Net product revenue from Kuvan (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), was $15.1 million for the fourth quarter of 2008 and $46.7 million for the year ended December 31, 2008.

Collaborative Agreement Revenues

Collaborative agreement revenues for the fourth quarter of 2008 were $31.5 million and included the $30 million milestone payment from Merck Serono for Kuvan marketing approval in the E.U., compared to $17.5 million for the fourth quarter of 2007 which included the $15 million milestone payment from Merck Serono for the filing of the MAA for Kuvan. Collaborative agreement revenues for the year ended December 31, 2008 were $38.9 million, compared to $28.3 million for the year ended December 31, 2007.

Impairment Loss on Investments

In the fourth quarter of 2008, BioMarin recorded an impairment charge of $4.1 million for the decline in the value of its equity investment in Summit Corporation plc. Based on the current market conditions, the low volume of trading in Summit securities and its current financial condition, BioMarin determined that its investment in Summit was impaired as of year end and adjusted the recorded amount of its investment to the stock’s market price on December 31, 2008. The remaining investment in Summit Corporation plc. of $1.6 million is reflected on the balance sheet as of December 31, 2008.

2009 Guidance

Revenue Guidance ($ in millions)

 

Item

   2009 Guidance    2008 Actual

Total BioMarin Revenues

   $ 307 to $336    $ 296.5

Total Net Product Revenues

   $ 300 to $329    $ 251.9

Naglazyme Net Product Revenue

   $ 160 to $175    $ 132.7

Kuvan Net Product Revenue

   $ 70 to $80    $ 46.7

Aldurazyme Net Product Revenue to BioMarin*

   $ 69 to $74    $ 72.5

 

* The 2009 Aldurazyme guidance, as compared to 2008, reflects increased royalties earned offset by a reduction of $7 million to $9 million in net incremental product transfer revenue, mostly related to the initial inventory transfer.

 

Page 2 of 7


Selected Income Statement Guidance ($ in millions)

 

Item

   Guidance

Cost of Sales (% of Total Revenue)

   19% to 21%

Selling, General and Admin. Expense

   $120 to $130

Research and Development Expense*

   $110 to $120

Costs Associated with Riquent Deal**

   Up to $15

Interest Income

   $5 to $7

Net Income (Loss) (GAAP)

   $(15) to $0

Stock Compensation Expense

   $32 to $35

Net Income (non-GAAP)

   $17 to $35

 

* Excludes upfront research and development expenses associated with the Riquent deal

 

** Represents upfront costs associated with the Riquent deal to be allocated between research and development expense and investment impairment

BioMarin estimates that top line product revenue will grow approximately 20% to 25% in 2010 and approximately 15% to 20% in 2011. These revenue estimates reflect growth from existing commercial products and do not include potential sales from additional new products. BioMarin expects GAAP net income in the range of $35 million to $40 million in 2010 and in the range of $60 million to $65 million in 2011. Excluding stock compensation expense, non-GAAP net income is projected to be in the range of $70 million to $80 million in 2010 and in the range of $95 million to $105 million in 2011. These estimates are based on BioMarin’s current business plan and do not include the effect of any significant business development transaction that the company may choose to do in the future.

Non-GAAP Financial Information and Reconciliation

The above results for the fourth quarter and full year of 2007 and 2008 and financial guidance for 2009, 2010 and 2011 include actual and Management’s 2009, 2010 and 2011 estimated net income, respectively, determined in accordance with GAAP and non-GAAP net income. As used in this release, non-GAAP income is net income calculated in accordance with GAAP, but excluding non-cash stock compensation expense, a non-GAAP financial measure. Stock compensation expense excluded in the calculation of non-GAAP net income was $7.4 million for the fourth quarter of 2008, $5.5 million for the fourth quarter of 2007, $25.3 million for the year ended December 31, 2008 and $18.3 million for the year ended December 31, 2007. Management estimates stock compensation expense of $32.0 million to $35.0 million in 2009, approximately $35.0 million to $40.0 million in 2010 and approximately $35.0 million to $40.0 million in 2011. The reconciliation of this measure to the estimated GAAP net income is as follows (in millions):

 

     Q4 2008    Q4 2007    Year Ended
December 31,
2008
   Year Ended
December 31,
2007
   2009 Guidance    2010 Guidance    2011 Guidance

GAAP net income (loss)

   $ 24.5    $ 2.6    $ 30.8      $(15.8)      $(15.0) -$0    $ 35.0 -$40.0    $ 60.0 - $65.0

Non-cash stock compensation expense

     7.4      5.5      25.3      18.3      32.0 -35.0      35.0 - 40.0      35.0 - 40.0
                                                

Non-GAAP net income

   $ 31.9    $ 8.1    $ 56.1    $ 2.5    $ 17.0 -$35.0    $ 70.0 -$80.0    $ 95.0 - $105.0
                                                

Management believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin’s GAAP information because Management uses such information internally for its operating, budgeting and financial planning purposes, and to enhance investors’ overall understanding of the company’s prospects for the future.

 

Page 3 of 7


Diluted Earnings Per Share Calculation

GAAP diluted earnings per share for the fourth quarter of 2008 and non-GAAP diluted earnings per share for the fourth quarter and full year 2008 includes 26.3 million shares related to the outstanding convertible debt. The calculation of GAAP diluted earnings per share for the fourth quarter of 2008 and non-GAAP diluted earnings per share for the fourth quarter and full year 2008 reflects the exclusion of the theoretical interest expense from net earnings that would no longer be incurred if the debt was converted into shares. For the full year 2008 GAAP diluted earnings per share and the fourth quarter and full year 2007 GAAP and non-GAAP diluted earnings per share, the 26.3 million shares related to the convertible debt are excluded from the diluted earnings per share calculation as their impact is considered anti-dilutive.

Anticipated Upcoming Milestones

 

   

1Q09: Results from BH4+Vitamin C study

 

   

1Q09: Results from Phase 2 PAH trial

 

   

1Q09/2Q09: Initiation of Phase 1 trial for GALNS for MPS IVA

 

   

2Q09: Results from proteinuria in chronic kidney disease trial

 

   

2Q09: Results from PEG-PAL Phase 1 trial

 

   

2Q09: Initiation of PEG-PAL Phase 2 trial

Upcoming Investor Conferences and Events

 

   

March 4-5: Credit Suisse Global Healthcare Conference

 

   

March 10-11: Barclays Healthcare Conference

 

   

March 16-18: Cowen Healthcare Conference

 

   

April 1: Citi Biotech Day

BioMarin will host a conference call and webcast to discuss fourth quarter and full year 2008 financial results today, Wednesday, February 18, at 5:00 p.m. ET (22:00 CET). This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.

Date: February 18, 2009

Time: 5:00 p.m. ET (22:00 CET)

U.S. / Canada Dial-in Number: 866.700.6293

International Dial-in Number: 617.213.8835

Participant Code: 35749059

Replay Dial-in Number: 888.286.8010

Replay International Dial-in Number: 617.801.6888

Replay Code: 73992450

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises three approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of sickle cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase 1 clinical development for the treatment of PKU. For additional information, please visit www.BMRN.com. Information on BioMarin’s website is not incorporated by reference into this press release.

 

Page 4 of 7


Forward-Looking Statement

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the expectations of revenue and sales related to Naglazyme, Kuvan, and Aldurazyme; the financial performance of the BioMarin as a whole; the timing of BioMarin’s clinical trials of 6R-BH4 for other indications, PEG-PAL, GALNS and other product candidates; the continued clinical development and commercialization of Aldurazyme, Naglazyme, Kuvan, and its product candidates; and actions by regulatory authorities. 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 and Kuvan; Genzyme Corporation’s success in continuing the commercialization of Aldurazyme; 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 Kuvan; actual sales of Aldurazyme, Naglazyme and Kuvan; Merck Serono’s activities related to Kuvan; the results of the final analysis of the ASPEN trial by La Jolla Pharmaceuticals; 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 2007 Annual Report on Form 10-K, and the factors contained in BioMarin’s reports on Form 10-Q. 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®, Naglazyme® and Kuvan® are registered trademarks of BioMarin Pharmaceutical Inc.

Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.

 

Page 5 of 7


BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

December 31, 2007 and 2008

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

 

     December 31,
2007
    December 31,
2008
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 228,343     $ 222,900  

Short-term investments

     357,251       336,892  

Accounts receivable, net

     16,976       54,298  

Advances to BioMarin/Genzyme LLC

     2,087       174  

Inventory

     32,445       73,162  

Other current assets

     7,195       50,270  
                

Total current assets

     644,297       737,696  

Investment in BioMarin/Genzyme LLC

     44,881       915  

Other investments

     —         1,633  

Property, plant and equipment, net

     76,818       124,979  

Intangible assets, net

     9,596       7,626  

Goodwill

     21,262       21,262  

Other assets

     18,425       12,584  
                

Total assets

   $ 815,279     $ 906,695  
                
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable and accrued liabilities

   $ 49,907     $ 58,851  

Current portion of acquisition obligation, net of discount

     6,309       70,741  

Deferred revenue

     5,327       307  

Other current liabilities

     —         182  
                

Total current liabilities

     61,543       130,081  

Convertible debt

     497,375       497,083  

Long-term portion of acquisition obligation, net of discount

     66,553       —    

Other long-term liabilities

     2,082       2,856  
                

Total liabilities

     627,553       630,020  
                

Stockholders’ equity:

    

Common stock, $0.001 par value: 250,000,000 shares authorized at December 31, 2007 and December 31, 2008; 97,114,159 and 99,868,145 shares issued and outstanding at December 31, 2007 and 2008, respectively

     97       100  

Additional paid-in capital

     794,917       852,947  

Company common stock held by deferred compensation plan

     —         (882 )

Accumulated other comprehensive income

     139       1,106  

Accumulated deficit

     (607,427 )     (576,596 )
                

Total stockholders’ equity

     187,726       276,675  
                

Total liabilities and stockholders’ equity

   $ 815,279     $ 906,695  
                

See accompanying notes to consolidated financial statements.

 

Page 6 of 7


BIOMARIN PHARMACEUTICAL INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three and Twelve Months Ended, December 31, 2007 and 2008

(In thousands, except per share data)

 

     Three Months Ended
December 31,
unaudited
    Twelve Months Ended
December 31,
 
     2007     2008     2007     2008  

Revenues:

        

Net product sales

   $ 26,202     $ 65,956     $ 86,802     $ 251,851  

Collaborative agreement revenues

     17,506       31,518       28,264       38,907  

Royalty and license fee revenues

     1,146       1,803       6,515       5,735  
                                

Total revenues

     44,854       99,277       121,581       296,493  

Operating expenses:

        

Cost of sales (excludes amortization)

     5,224       11,665       18,359       52,509  

Research and development

     24,015       25,733       78,600       93,291  

Selling, general and administrative

     23,891       28,730       77,539       106,566  

Amortization of intangible assets

     1,093       1,093       4,371       4,371  
                                

Total operating expenses

     54,223       67,221       178,869       256,737  
                                

Income (loss) from operations

     (9,369 )     32,056       (57,288 )     39,756  

Equity in the income (loss) of BioMarin/Genzyme LLC

     9,366       (579 )     30,525       (2,270 )

Interest income

     7,383       3,231       25,932       16,388  

Interest expense

     (4,080 )     (4,096 )     (14,243 )     (16,394 )

Impairment loss on investment

     —         (4,056 )     —         (4,056 )
                                

Income (loss) before income taxes

     3,300       26,556       (15,074 )     33,424  

Income Taxes

     729       2,050       729       2,593  

Net income (loss)

   $ 2,571     $ 24,506     $ (15,803 )   $ 30,831  
                                

Net income (loss) per share, basic

   $ 0.03     $ 0.25     $ (0.16 )   $ 0.31  
                                

Net income (loss) per share, diluted

   $ 0.03     $ 0.21     $ (0.16 )   $ 0.29  
                                

Weighted average common shares outstanding, basic

     96,931       99,777       95,878       98,975  
                                

Weighted average common shares outstanding, diluted

     101,193       128,296       95,878       103,572  
                                

The following is the stock-based compensation expense included in the respective captions of the consolidated statements of operations above:

  

     Three Months Ended
December 31,
unaudited
    Twelve Months Ended
December 31,
 
     2007     2008     2007     2008  

Cost of sales

   $ 162     $ 503     $ 578     $ 1,521  

Selling, general and administrative expense

     3,092       4,471       10,727       15,145  

Research and development expense

     2,211       2,466       6,978       8,584  
                                

Total stock-based compensation expense

   $ 5,465     $ 7,440     $ 18,283     $ 25,250  
                                

###

 

Page 7 of 7