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8-K - FORM 8-K - GENZYME CORPb85002e8vk.htm
EX-2.1 - EX-2.1 - GENZYME CORPb85002exv2w1.htm
EX-99.2 - EX-99.2 - GENZYME CORPb85002exv99w2.htm
EX-10.1 - EX-10.1 - GENZYME CORPb85002exv10w1.htm
Exhibit 99.1
(GENZYME LOGO)
         
For Immediate Release
  Media Contact:   Investor Contact:
February 16, 2011
  Erin Emlock
(617) 768-6923
  Patrick Flanigan
(617) 768-6563
Genzyme Reports Financial Results for Fourth Quarter of 2010 and Full Year
 
Recovery Continues with Growth Across All Businesses
CAMBRIDGE, Mass. — Genzyme Corp. (NASDAQ: GENZ) today reported fourth-quarter 2010 results that reflect increasing supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta), revenue growth across all major product lines, and reductions in operating expenses. Earlier today Genzyme and sanofi-aventis announced that they have reached a definitive agreement under which sanofi-aventis will acquire Genzyme for $74 per share plus a contingent value right. This news is covered in a separate press release.
Fourth-quarter GAAP net income was $471.9 million, or $1.76 per diluted share, compared with $23.2 million, or $0.09 per diluted share, in the same period in 2009. Non-GAAP net income was $221.1 million, or $0.82 per diluted share, compared with $78.1 million, or $0.29 per diluted share, in the fourth quarter of 2009. Non-GAAP 2010 income excludes items associated with business divestitures, Bayer oncology product acquisition expenses, and stock compensation expenses.
Full-year 2010 GAAP net income was $422.1 million, or $1.57 per diluted share, compared with $422.3 million, or $1.54 per diluted share, in 2009. Non-GAAP net income was $478.5 million, or $1.78 per diluted share, compared with $611.5 million, or $2.23 per diluted share, in 2009. Genzyme exited 2010 with $1.9 billion in cash and equivalents.
Fourth-quarter GAAP revenue grew 23 percent to $1.15 billion from $938.3 million in the fourth quarter of 2009; non-GAAP revenue was $1.13 billion. For the year, GAAP revenue was $4.05 billion compared with $3.98 billion in 2009; non-GAAP revenue was $4.03 billion. Non-GAAP revenue figures exclude the pharmaceuticals and cell therapy businesses, which Genzyme intends to divest.
“Strong growth in the fourth quarter demonstrates that our recovery is fully underway,” said Henri A. Termeer, Genzyme’s chairman and CEO. “By executing on the opportunities provided by our core businesses and reducing our operating expenses, we were able to nearly double our earnings from the third quarter to the fourth.”
Genzyme expects to achieve several important manufacturing and product-related milestones during 2011, including:
    Ceasing the remaining fill/finish activities at the Allston facility for all products and transferring those operations to a contract manufacturer during the first half of the year;
 
    Announcing top-line data from the first phase 3 trial of alemtuzumab for multiple sclerosis mid-year and from the second trial in the second half of the year;

 


 

    Fully supplying existing patient demand for Fabrazyme and receiving approval for its production at the new Framingham plant, both expected during the second half of 2011; and
 
    Maintaining the existing full supply of Cerezyme.
The company is continuing to make progress in implementing its plan to increase shareholder value, which includes the divestitures of non-core businesses. In the fourth quarter, Genzyme completed the sale of its Genetics business, and the company this quarter completed the sale of its Diagnostics business and entered into an agreement to sell its Pharmaceuticals business.
As part of the company’s initiative to improve its operating margins, Genzyme last year implemented a program focused on identifying sustainable cost savings opportunities across the organization. This resulted in $26 million in savings during the fourth quarter and is expected to create $275 million in savings in 2011.
Along with the expected 2011 milestones, Genzyme expects that supply recovery, business growth and the company’s late-stage pipeline will serve as growth drivers this year.
Supply Recovery of Cerezyme and Fabrazyme
The recovery of Cerezyme supply is on track, with currently treated patients back to full supply and bioreactor performance at the higher end of historical experience. Fabrazyme supply is improving and allocations increased 82 percent from the third quarter to the fourth.
Genzyme is ahead of schedule in its plans to expand its biologics and fill/finish manufacturing capacity. Fabrazyme process validation runs at the company’s new Framingham manufacturing facility have begun, and the material created through these runs will become commercial product inventory upon regulatory approval of Fabrazyme production at this facility. This approval is expected during the second half of this year and will enable the company to provide full, sustainable product supply.
During the fourth quarter, Genzyme ceased fill/finish operations at its Allston facility for products sold in the United States, and the company plans to transfer the remaining fill/finish operations to a contract manufacturer during the first half of this year. An expansion of fill/finish operations at the Waterford site creating a four-fold capacity increase is expected to be approved in late 2011.
Business Unit Revenue Growth
Record revenue in the fourth quarter shows strength across each of Genzyme’s businesses. In 2011, the company expects double-digit revenue growth, driven primarily by Cerezyme and Fabrazyme. In addition, Genzyme expects strong growth from its Pompe disease treatments Myozyme® (alglucosidase alfa) and Lumizyme® (alglucosidase alfa); its viscosupplement treatments Synvisc® (hylan G-F 20) and Synvisc-One® (hylan G-F 20); and its Hematology and Oncology business.
Personalized Genetic Health
Fourth-quarter revenue from the Personalized Genetic Health business grew 45 percent to $505.6 million from $348.0 million in same period in 2009, and 25 percent from $404.2 million in

 


 

the third quarter of 2010. This growth reflects increasing supplies of Cerezyme and Fabrazyme, and the U.S. launch of Lumizyme.
The company’s Pompe disease treatments represent an opportunity that is comparable to that of Cerezyme for Gaucher disease. The company estimates that there are about 10,000 Pompe patients worldwide; approximately 1,400 Pompe patients are currently treated with either Myozyme or Lumizyme, which are the only treatments approved for the disease.
Fourth-quarter revenue of Myozyme/Lumizyme grew 39 percent to $127.5 million compared with $91.9 million in the same period in 2009. Full-year sales increased 27 percent to $411.8 million compared with $324.5 million in 2009. Increases in both fourth-quarter and full-year revenue reflect, in part, sales of Lumizyme following FDA approval in May 2010. U.S. sales of Myozyme/Lumizyme in the fourth quarter were $30.3 million. Myozyme is currently available in 48 markets worldwide and Genzyme expects to increase this to 60 markets by the end of this year.
Fourth-quarter sales of Cerezyme were $222.0 million compared with $105.4 million in the same period in 2009, and full-year sales were $719.6 million compared with $793.0 million in 2009. Genzyme recently won a six-month tender for Cerezyme in Brazil that covers the first half of 2011. Sales of Fabrazyme in the fourth quarter were $61.6 million compared with $58.0 million in the fourth quarter of 2009; full-year sales were $188.2 million compared with $429.7 million in 2009.
Biosurgery
GAAP revenue from Genzyme’s Biosurgery business grew to $628.8 million in 2010 from $561.8 million in 2009, driven by its viscosupplement treatments Synvisc and Synvisc-One. Non-GAAP 2010 revenue was $615.8 million. GAAP fourth-quarter 2010 revenue was $170.7 million compared with $157.3 million in the same period in 2009; non-GAAP revenue was $157.7 million. Non-GAAP revenue figures exclude the cell therapy business, which Genzyme intends to divest.
Synvisc-One, which was launched in the first quarter of 2009, is the only single-injection viscosupplement approved for the treatment of osteoarthritis (OA) knee pain in the United States, a market that is large, growing and under-penetrated. The percentage of the approximately 9 million eligible OA patients in the United States who are currently treated with viscosupplements grew last year from 14 to 16 percent.
Fourth-quarter sales of Synvisc and Synvisc-One grew 11 percent to $105.9 million compared with $95.4 million in the fourth quarter of 2009, and full-year sales increased 19 percent to $393.1 million compared with $328.5 million in 2009. Genzyme in the fourth quarter received approval of Synvisc in Japan, the largest market in the world for viscosupplements.
Hematology and Oncology
Full-year revenue from Genzyme’s Hematology and Oncology business grew 32 percent to $678.8 million in 2010 from $512.9 in 2009, primarily driven by the ongoing launch of Mozobil® (plerixafor injection), the significant growth of Clolar® (clofarabine) in the U.S. and Europe and a full year of sales for the products acquired from Bayer. Fourth quarter revenue was $178.7 million compared with $168.8 million in the same period in 2009.

 


 

In 2011, Genzyme expects growth in this business to be driven primarily by Mozobil, Thymoglobulin® (anti-thymocyte globulin (rabbit)) and Clolar through increased penetration in key segments of the U.S. and mature European markets, and expansion in emerging markets such as China. During the second half of this year, the company expects data from a clinical trial of Clolar in adult patients with acute myelogenous leukemia, which if positive could potentially support regulatory filings for an expanded indication for the product.
Renal and Endocrinology
The company’s Renal and Endocrinology business performed extremely well in the fourth quarter, delivering 12 percent growth with revenue of $288.9 million compared with $258.2 million in the fourth quarter of 2009. This was driven by strong Renvela® (sevelamer carbonate) performance in the United States, where it remains the market leading phosphate binder; the launch of Renvela in major EU markets including France and Italy; and the new tender in Brazil. Full-year 2010 revenue from the business was $1.07 billion, compared with $1.01 billion in 2009.
Genzyme recently completed a pivotal study of Renvela in Chinese patients with chronic kidney disease (CKD) on dialysis. The study met its primary endpoint, and the company anticipates filing for approval of Renvela’s use in treating hyperphosphatemic dialysis patients in China during the first half of 2011. The company expects sustainable growth of Renvela in 2011 as it continues to launch the product in Europe, where the company has marketing approval for the product’s use in hyperphosphatemic CKD patients who are on dialysis, and in those who are not on dialysis.
Promising Late-Stage Pipeline
Within Genzyme’s late-stage product pipeline, three approvals are expected by the end of 2013: alemtuzumab for multiple sclerosis, mipomersen for familial hypercholesterolemia, and eliglustat tartrate for Gaucher disease type 1.
    Based on promising phase 2 data, alemtuzumab has the potential to become a new standard of care for multiple sclerosis treatment, a market that is expected to reach $13 billion by 2012. Two phase 3 trials are fully enrolled; results of the trial in treatment-naïve patients are expected mid-year, and results of the trial in treatment-experienced patients are expected during the second half of this year. Genzyme anticipates U.S. approval of the treatment in the second half of 2012.
 
    Genzyme is partnering with Isis Pharmaceuticals Inc. on the development of mipomersen for familial hypercholesterolemia (FH) patients who are unable to achieve healthy LDL-cholesterol levels with current treatments. The companies have completed four phase 3 trials of the novel treatment, all of which met their primary endpoints. Genzyme plans to file for EU approval of the treatment for patients with homozygous FH (HoFH) in the first half of this year. This filing may also include severe heterozygous FH (HeFH). Following recent FDA feedback, Genzyme is determining the timing of the U.S. HoFH filing, which may shift to the second half of this year.
 
    Three-year follow-up data from the phase 2 study of eliglustat tartrate, Genzyme’s investigational oral therapy for patients with Gaucher disease type 1, will be presented this week at the Lysosomal Disease Network WORLD Symposium. At the three-year

 


 

      timepoint, sustained or further improvements were observed across all endpoints, including bone disease, compared with baseline. Eliglustat tartrate, which is currently in phase 3 trials, has the potential to transform the treatment experience for patients with Gaucher disease by providing an oral capsule option instead of bi-weekly infusions.
About Genzyme
One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with approximately 10,000 employees in locations spanning the globe.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.
This press release contains forwarding-looking statements regarding Genzyme’s financial results and outlook and business plans and strategies including, without limitation: expectations regarding revenue growth; the expected completion and timing of ceasing fill/finish operations at the Allston facility and the transfer of those operations; the anticipated receipt and timing of alemtuzumab clinical trial data results; expectations regarding Fabrazyme supply and meeting patient demand; expectations regarding the timing and results of validation runs at, and receipt and timing of regulatory approval of, the new Framingham facility; expectations regarding the supply of Cerezyme; the expected receipt and timing of regulatory approval of the expanded fill/finish operations at the Waterford facility; expectations regarding Myozyme/Lumizyme commercial opportunities and future growth; plans to divest additional businesses, including the cell therapy business, and the timing of such divestitures; the expected amount of savings resulting from cost-saving efforts and opportunities; the expected receipt, timing and results of clinical trial data for Clolar; the anticipated timing of filing for regulatory approval for Renvela in China; the expected receipt and timing of regulatory approvals for alemtuzumab, mipomersen and eliglustat tartrate; the expected size of the MS market and expectations regarding submissions, including scope and timing, of regulatory filings for mipomersen. These statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks and uncertainties include, among others: that production and shipment of Fabrazyme and Cerezyme does not continue as planned due to any reason, including contamination, equipment malfunctions, cell growth at lower than expected levels, fill-finish inefficiencies, power outages, human error or regulatory issues; that Genzyme’s business is negatively impacted by adverse events or circumstances, including further manufacturing issues, lower than expected product demand due to competition or higher than expected operating expenses; that Genzyme cannot obtain on expected timetables or maintain regulatory approvals for its products and manufacturing facilities, including the Allston manufacturing facility, the new Framingham facility, and the expanded fill/finish operations in Waterford; that Genzyme is unable to successfully transition fill/finish operations out of the Allston facility on

 


 

planned timelines; that Genzyme is not able to successfully complete clinical development and obtain regulatory approvals of its pipeline products within anticipated timeframes and for anticipated indications, including alemtuzumab-MS, mipomersen and eliglustat tartrate for any reason, including trial results that are not as favorable as expected and safety profiles that reduce the potential target patient population; that Genzyme is unable to complete the sale of its pharmaceuticals business or sell other businesses as planned or on anticipated timeframes; that Genzyme will not be able to implement its plan to increase shareholder in a manner consistent with expectations, including an inability to reduce operating expenses or sustain any achieved cost savings as expected; that Genzyme is unable to accurately assess, estimate or forecast patient populations and product demand; and the risks and uncertainties described in Genzyme’s SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption “Risk Factors” in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Genzyme’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Genzyme undertakes no obligation to update or revise them.
Genzyme®, Cerezyme®, Fabrazyme®, Myozyme®, Lumizyme®, Synvisc®, Synvisc-One®, Renvela®, Mozobil®, Clolar® and Thymoglobulin® are registered trademarks of Genzyme Corporation or its subsidiaries. All rights reserved.
Important Information
Genzyme has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer by sanofi-aventis. Genzyme shareholders are advised to read the company’s Solicitation/Recommendation Statement on Schedule 14D-9 because it contains important information. Shareholders may obtain a free copy of the Solicitation/Recommendation Statement on Schedule 14D-9, as well as any other documents filed by Genzyme in connection with the tender offer, free of charge at the SEC’s website at http://www.sec.gov. In addition, investors can obtain free copies of these documents from Genzyme by directing a request to Genzyme at 500 Kendall Street, Cambridge, MA 02142, Attention: Shareholder Relations Department, or by calling 617-252-7500 and asking for the Shareholder Relations Department.
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GENZYME CORPORATION (GENZ)  
Consolidated Statements of Operations   Three Months Ended     Year Ended  
(Unaudited, amounts in thousands, except per share amounts)   December 31,     December 31,  
    2010     2009(1)     2010     2009(1)  
 
Total revenues
  $ 1,151,853     $ 938,290     $ 4,048,708     $ 3,977,288  
 
                       
 
                               
Operating costs and expenses:
                               
Cost of products and services sold
    335,067       296,136       1,191,540       1,070,347  
Selling, general and administrative
    350,002       340,374       1,553,921       1,244,398  
Research and development
    202,097       224,918       847,284       833,853  
Amortization of intangibles
    67,927       70,237       262,254       253,507  
Restructuring charges
    28,260             28,260        
Contingent consideration expense
    33,310             102,746        
Charge for impaired assets
    26,873       28,297       26,873       65,584  
 
                       
Total operating costs and expenses
    1,043,536       959,962       4,012,878       3,467,689  
 
                       
Operating income (loss)
    108,317       (21,672 )     35,830       509,599  
 
                       
 
                               
Other income (expenses):
                               
Equity in loss of equity method investments
    (795 )           (3,004 )      
Gains (losses) on investments in equity securities, net
    (3,583 )     1,276       (30,334 )     (57 )
Gain on acquisition of business
                      24,159  
Other
    1,109       700       465       (1,646 )
Investment income
    2,595       3,605       11,382       17,642  
Interest expense
    (3,668 )           (7,026 )      
 
                       
Total other income (expenses)
    (4,342 )     5,581       (28,517 )     40,098  
 
                       
Income (loss) from continuing operations before taxes
    103,975       (16,091 )     7,313       549,697  
(Provision for) benefit from income taxes
    (32,968 )     37,608       24,750       (122,766 )
 
                       
Income (loss) from continuing operations, net of tax
    71,007       21,517       32,063       426,931  
Income (loss) from discontinued operations, net of tax
    400,904       1,728       390,081       (4,631 )
 
                       
Net income (loss)
  $ 471,911     $ 23,245     $ 422,144     $ 422,300  
 
                       
 
                               
Net income (loss) per share-basic:
                               
Income (loss) from continuing operations, net of tax
  $ 0.27     $ 0.08     $ 0.12     $ 1.59  
Income (loss) from discontinued operations, net of tax
  $ 1.55     $ 0.01     $ 1.49     $ (0.02 )
 
                       
Net income (loss)
  $ 1.82     $ 0.09     $ 1.61     $ 1.57  
 
                       
 
                               
Net income (loss) per share-diluted:
                               
Income (loss) from continuing operations, net of tax
  $ 0.27     $ 0.08     $ 0.12     $ 1.56  
Income (loss) from discontinued operations, net of tax
  $ 1.49     $ 0.01     $ 1.45     $ (0.02 )
 
                       
Net income (loss)
  $ 1.76     $ 0.09     $ 1.57     $ 1.54  
 
                       
 
                               
Weighted average shares outstanding:
                               
Basic
    259,245       265,596       261,531       268,841  
Diluted
    268,513       270,241       268,601       274,071  
                 
GENZYME CORPORATION (GENZ)  
Condensed Consolidated Balance Sheets   December 31,     December 31,  
(Unaudited, amounts in thousands)   2010     2009  
 
 
               
Cash and all marketable securities
  $ 1,950,022     $ 1,049,700  
Assets held for sale-current
    77,690        
Other current assets
    2,235,383       1,896,927  
Property, plant and equipment, net
    2,925,585       2,809,349  
Intangibles, net
    3,181,797       3,716,625  
Assets held for sale-noncurrent
    91,836        
Other noncurrent assets
    678,762       588,123  
 
           
Total assets
  $ 11,141,075     $ 10,060,724  
 
           
 
               
Liabilities associated with assets held for sale-current
  $ 21,368     $  
Other current liabilities
    1,444,555       1,080,130  
Noncurrent liabilities
    2,033,305       1,296,942  
Stockholders’ equity
    7,641,847       7,683,652  
 
           
Total liabilities and stockholders’ equity
  $ 11,141,075     $ 10,060,724  
 
           
 
All amounts herein are presented in accordance with GAAP and are provided for quantitative analysis only and should be read in conjunction with the text of the Earnings Release. Please refer to our Form 10-Q’s and Form 10-K’s for an in-depth discussion and analysis of our results of operations and financial position and for detailed information regarding specific material transactions in a particular period.
In addition, we believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’s past financial performance and its prospects for the future. Please refer to our GAAP to Non-GAAP Reconciliations attached to the Earnings Releases for the above respective periods, which are filed on Form 8-K with the Securities and Exchange Commission at www.sec.gov. The Non-GAAP financial measures are provided with the intent of providing investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators management uses for planning and forecasting purposes and measuring the company’s performance.
(1) 2009 consolidated statements of operations have been revised to reflect discontinued operations. Discontinued operations represents the operations of Genzyme Genetics and Genzyme Diagnostics, net of tax.


 

                                                                             
Genzyme Corporation (GENZ)  
Analyst Schedule  
(Amounts in thousands, except percentage amounts)  
PRIOR PERIODS REVISED FOR DISCONTINUED OPERATIONS - UNAUDITED       Q4-10                      
                                              vs.                      
                                              Q4-09                      
    Q4-09     Q1-10     Q2-10     Q3-10     Q4-10       % B/(W)       FY 2008     FY 2009     FY 2010  
Total revenues:
                                                                           
Personalized Genetic Health
                                                                           
Cerezyme
  $ 105,368     $ 179,147     $ 138,736     $ 179,781     $ 221,966         111 %     $ 1,238,977     $ 793,024     $ 719,630  
Fabrazyme
    58,026       53,241       39,484       33,882       61,603         6 %       494,260       429,690       188,210  
Myozyme
    91,900       86,059       92,054       106,223       127,467         39 %       296,176       324,545       411,803  
Aldurazyme
    38,706       39,897       43,651       40,766       42,466         10 %       151,664       155,064       166,780  
Other Personalized Genetic Health
    54,042       34,160       36,619       43,531       52,052         (4 %)       114,950       147,285       166,362  
 
                                                           
Total Personalized Genetic Health product and service revenue
    348,042       392,504       350,544       404,183       505,554         45 %       2,296,027       1,849,608       1,652,785  
R&D Revenue
                                              110              
 
                                                           
Total Personalized Genetic Health
    348,042       392,504       350,544       404,183       505,554         45 %       2,296,137       1,849,608       1,652,785  
 
                                                           
Renal and Endocrinology
                                                                           
Renagel and Renvela (including Sevelamer)
    178,891       164,607       170,066       178,755       184,222         3 %       677,729       706,590       697,650  
Hectorol
    31,877       42,025       41,863       49,285       56,705         78 %       128,153       130,757       189,878  
 
                                                           
Subtotal
    210,768       206,632       211,929       228,040       240,927         14 %       805,882       837,347       887,528  
Thyrogen
    47,267       45,625       46,300       42,257       47,772         1 %       148,448       170,644       181,954  
Other Renal and Endocrinology
                                                    30        
 
                                                           
Total Renal and Endocrinology product and service revenue
    258,035       252,257       258,229       270,297       288,699         12 %       954,330       1,008,021       1,069,482  
R&D revenue
    155       166       150       134       178         15 %       90       331       628  
 
                                                             
Total Renal and Endocrinology
    258,190       252,423       258,379       270,431       288,877         12 %       954,420       1,008,352       1,070,110  
 
                                                           
Biosurgery
                                                                           
Synvisc
    95,419       79,507       107,686       99,998       105,885         11 %       263,094       328,533       393,076  
Sepra products
    40,365       37,177       38,935       40,858       44,026         9 %       133,663       148,538       160,996  
Other Hyaluronic Acid products
    6,698       8,984       4,818       5,908       6,937         4 %       45,587       34,597       26,647  
 
                                                           
Total Hyaluronic Acid product and service revenue
    142,482       125,668       151,439       146,764       156,848         10 %       442,344       511,668       580,719  
Cell Based Therapy
    14,081       10,645       11,837       9,510       12,996         (8 %)       42,547       45,789       44,988  
Other Biosurgery
    343       494       300       258       360         5 %       3,564       1,866       1,412  
 
                                                           
Total Biosurgery product and service revenue
    156,906       136,807       163,576       156,532       170,204         8 %       488,455       559,323       627,119  
R&D revenue
    414       559       404       200       468         13 %       2,645       2,493       1,631  
 
                                                           
Total Biosurgery
    157,320       137,366       163,980       156,732       170,672         8 %       491,100       561,816       628,750  
 
                                                           
Hematology and Oncology
                                                                           
Mozobil
    19,267       18,966       22,141       23,630       27,284         42 %       639       54,650       92,021  
Thymoglobulin
    58,265       52,910       58,232       56,891       61,885         6 %       183,296       215,964       229,918  
Clolar
    22,230       24,688       25,520       26,129       27,564         24 %       64,044       81,280       103,901  
Other Hematology and Oncology
    68,977       59,727       70,597       60,645       61,858         (10 %)       47,120       158,658       252,827  
 
                                                           
Total Hematology and Oncology product and service revenue
    168,739       156,291       176,490       167,295       178,591         6 %       295,099       510,552       678,667  
R&D revenue
    24       19       7       1       80         233 %       14,439       2,367       107  
 
                                                             
Total Hematology and Oncology
    168,763       156,310       176,497       167,296       178,671         6 %       309,538       512,919       678,774  
 
                                                           
Multiple Sclerosis R&D revenue
    110                                 (100 %)       21,709       12,467        
 
                                                           
Other
                                                                           
Other product and service revenue
    5,137       3,099       3,397       2,848       7,841         53 %       51,473       29,442       17,185  
 
                                                           
Total Other product and service revenue
    5,137       3,099       3,397       2,848       7,841         53 %       51,473       29,442       17,185  
R&D revenue
    728       189       367       310       238         (67 %)       3,048       2,684       1,104  
 
                                                             
Total Other
    5,865       3,288       3,764       3,158       8,079         38 %       54,521       32,126       18,289  
 
                                                           
Total revenues
  $ 938,290     $ 941,891     $ 953,164     $ 1,001,800     $ 1,151,853         23 %     $ 4,127,425     $ 3,977,288     $ 4,048,708  
 
                                                           
All amounts herein are presented in accordance with GAAP and are provided for quantitative analysis only and should be read in conjunction with the text of the Earnings Release and our audited financial statements filed with the Securities and Exchange Commission. Please refer to our Form 10-Q’s and Form 10-K’s for an in-depth discussion and analysis of our results of operations and financial position and for detailed information regarding specific material transactions in a particular period.


 

GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
For the Year Ended December 31, 2010
(Amounts in thousands, except percentage and per share data)
UNAUDITED
                                                                                                                         
                                                                                                    OTHER DISCRETE ITEMS  
                                                                                                    (included in GAAP and Non-GAAP results)  
                                Bayer     Stock                                                                
      GAAP       Consent     Acquisition     Compensation     Exit     Genzyme     Cell Based     Discontinued                         Manufacturing     Genzyme     Investment  
      As Reported       Decree     Related     Expense     Activities     Pharmaceuticals(5)     Therapy     Operations(3)       NON-GAAP(1)       Related(2)     Pharmaceuticals(5)     Impairment(4)  
                                 
Income Statement Classification:
                                                                                                                       
Total revenues
            $ 4,048,708       $     $     $     $     $ (5,658 )   $ (12,995 )   $               $ 4,030,055       $     $ (3,082 )   $  
Cost of products and services sold
            $ (1,191,540 )     $     $ 35,854     $ 19,041     $     $ 8,247     $ 15,037     $               $ (1,113,361 )     $ 44,938     $ 3,200     $  
 
                                                                                               
Gross margin
      71 %   $ 2,857,168       $     $ 35,854     $ 19,041     $     $ 2,589     $ 2,042                 72 %   $ 2,916,694       $ 44,938     $ 118     $  
Selling, general and administrative
            $ (1,553,921 )     $ 175,000     $     $ 89,575     $ 3,207     $ 2,169     $ 4,312     $               $ (1,279,658 )     $     $ 625     $  
Research and development
            $ (847,284 )     $     $     $ 54,470     $ 1,094     $ 938     $ 4,467     $               $ (786,315 )     $     $ 686     $  
Amortization of intangibles
            $ (262,254 )     $     $     $     $     $     $ 329     $               $ (261,925 )     $     $     $  
Restructuring charges
            $ (28,260 )     $     $     $     $ 28,260     $     $     $               $       $     $     $  
Contingent consideration expense
            $ (102,746 )     $     $ 102,746     $     $     $     $     $               $       $     $     $  
Charge for impaired assets
            $ (26,873 )             $     $     $     $ 26,873     $     $               $       $     $     $  
Equity in loss of equity method investments
            $ (3,004 )     $     $     $     $     $     $     $               $ (3,004 )     $     $     $  
Other
            $ (29,869 )     $     $     $     $     $     $     $               $ (29,869 )     $     $     $ 32,250  
Investment income
            $ 11,382       $     $     $     $     $     $     $               $ 11,382       $     $     $  
Interest expense
            $ (7,026 )     $     $     $     $     $     $ 2     $               $ (7,024 )     $     $     $  
                                 
 
                                                                                                                       
Summary:
                                                                                                                       
Income (loss) from continuing operations before income taxes
            $ 7,313       $ 175,000     $ 138,600     $ 163,086     $ 32,561     $ 32,569     $ 11,152     $               $ 560,281       $ 44,938     $ 1,429     $ 32,250  
(Provision for) benefit from income taxes
      -338.44 %   $ 24,750       $ (51,299 )   $ 6,120     $ (45,436 )   $ (8,214 )   $ (3,482 )   $ (4,240 )   $         14.60 %   $ (81,801 )     $ (12,633 )   $ (362 )   $ (11,909 )
 
                                                                                               
Income (loss) from continuing operations
            $ 32,063       $ 123,701     $ 144,720     $ 117,650     $ 24,347     $ 29,087     $ 6,912     $               $ 478,480       $ 32,305     $ 1,067     $ 20,341  
Income (loss) from discontinued operations, net of tax
            $ 390,081       $     $     $     $     $     $     $ (390,081 )             $       $     $     $  
 
                                                                                               
Net income (loss)
            $ 422,144       $ 123,701     $ 144,720     $ 117,650     $ 24,347     $ 29,087     $ 6,912     $ (390,081 )             $ 478,480       $ 32,305     $ 1,067     $ 20,341  
 
                                                                                               
 
                                                                                                                       
Net income (loss) per share-basic:
                                                                                                                       
Income (loss) from continuing operations, net of tax
            $ 0.12       $ 0.47     $ 0.55     $ 0.45     $ 0.09     $ 0.11     $ 0.03     $               $ 1.83       $ 0.12     $ 0.00     $ 0.08  
Income (loss) from discontinued operations, net of tax
            $ 1.49       $     $     $     $     $     $     $ (1.49 )             $       $     $     $  
 
                                                                                               
Net income (loss)
            $ 1.61       $ 0.47     $ 0.55     $ 0.45     $ 0.09     $ 0.11     $ 0.03     $ (1.49 )             $ 1.83       $ 0.12     $ 0.00     $ 0.08  
 
                                                                                               
 
                                                                                                                       
Net income (loss) per share-diluted:
                                                                                                                       
Income (loss) from continuing operations, net of tax
            $ 0.12       $ 0.46     $ 0.54     $ 0.44     $ 0.09     $ 0.11     $ 0.03     $               $ 1.78       $ 0.12     $ 0.00     $ 0.08  
Income (loss) from discontinued operations, net of tax
            $ 1.45       $     $     $     $     $     $     $ (1.45 )             $       $     $     $  
 
                                                                                               
Net income (loss)
            $ 1.57       $ 0.46     $ 0.54     $ 0.44     $ 0.09     $ 0.11     $ 0.03     $ (1.45 )             $ 1.78       $ 0.12     $ 0.00     $ 0.08  
 
                                                                                               
 
                                                                                                                       
Weighted average shares outstanding:
                                                                                                                       
Basic
              261,531         261,531       261,531       261,531       261,531       261,531       261,531       261,531                 261,531         261,531       261,531       261,531  
Diluted
              268,601         268,601       268,601       268,601       268,601       268,601       268,601       268,601                 268,601         268,601       268,601       268,601  
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme Corporation for the applicable period. We believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’s past financial performance and its prospects for the future. The Non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators management uses for planning and forecasting purposes and measuring the company’s performance. Such Non-GAAP financial measures should not be considered in isolation or used as a substitute for GAAP. Earnings per share are calculated as net income (loss) divided by weighted average shares outstanding. Therefore, earnings per share may not add across due to rounding.
(2) Represents write-offs of inventory that did not meet the necessary quality specifications.
(3) Discontinued Operations represents the operations of Genzyme Genetics and Genzyme Diagnostics, net of tax.
(4) Represents a write-down of our investment in the common stock of ISIS Pharmaceuticals, Inc., to the extent our cost exceeds the market value, in accordance with GAAP.
(5) Genzyme Pharmaceuticals was treated as a discrete item for Q3 2010 and a Non-GAAP item for Q4 2010.


 

GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
For the Three Months Ended December 31, 2010
(Amounts in thousands, except percentage and per share data)
UNAUDITED
                                                                                       
                        Bayer     Stock                                  
      GAAP       Acquisition     Compensation     Exit     Genzyme     Cell Based     Discontinued          
      As Reported       Related     Expense     Activities     Pharmaceuticals     Therapy     Operations(2)       NON-GAAP(1)  
                   
Income Statement Classification:
                                                                                     
Total revenues
            $ 1,151,853       $     $     $     $ (5,658 )   $ (12,995 )   $               $ 1,133,200  
Cost of products and services sold
            $ (335,067 )     $ 8,560     $ 4,842     $     $ 8,247     $ 15,037     $               $ (298,381 )
 
                                                                     
Gross margin
      71 %   $ 816,786       $ 8,560     $ 4,842             $ 2,589     $ 2,042                 74 %   $ 834,819  
Selling, general and administrative
            $ (350,002 )     $     $ 19,123     $     $ 2,169     $ 4,312     $               $ (324,398 )
Research and development
            $ (202,097 )     $     $ 13,103     $ 1,094     $ 938     $ 4,467     $               $ (182,495 )
Amortization of intangibles
            $ (67,927 )     $     $     $     $     $ 329     $               $ (67,598 )
Restructuring charges
            $ (28,260 )     $     $     $ 28,260     $     $     $               $  
Contingent consideration expense
            $ (33,310 )     $ 33,310     $     $     $     $     $               $  
Charge for impaired assets
            $ (26,873 )     $     $     $     $ 26,873     $     $               $  
Equity in loss of equity method investments
            $ (795 )     $     $     $     $     $     $               $ (795 )
Other
            $ (2,474 )     $     $     $     $     $     $               $ (2,474 )
Investment income
            $ 2,595       $     $     $     $     $     $               $ 2,595  
Interest expense
            $ (3,668 )     $     $     $     $     $ 2     $               $ (3,666 )
                   
 
                                                                                     
Summary:
                                                                                     
Income (loss) from continuing operations before income taxes
            $ 103,975       $ 41,870     $ 37,068     $ 29,354     $ 32,569     $ 11,152     $               $ 255,988  
(Provision for) benefit from income taxes
      31.71 %   $ (32,968 )     $ 21,514     $ (8,085 )   $ (7,610 )   $ (3,482 )   $ (4,240 )   $         13.62 %   $ (34,871 )
 
                                                                     
Income (loss) from continuing operations
            $ 71,007       $ 63,384     $ 28,983     $ 21,744     $ 29,087     $ 6,912     $               $ 221,117  
Income (loss) from discontinued operations, net of tax
            $ 400,904       $     $     $     $     $     $ (400,904 )             $  
 
                                                                     
Net income (loss)
            $ 471,911       $ 63,384     $ 28,983     $ 21,744     $ 29,087     $ 6,912     $ (400,904 )             $ 221,117  
 
                                                                     
 
                                                                                     
Net income (loss) per share-basic:
                                                                                     
Income (loss) from continuing operations, net of tax
            $ 0.27       $ 0.24     $ 0.11     $ 0.08     $ 0.11     $ 0.03     $               $ 0.85  
Income (loss) from discontinued operations, net of tax
            $ 1.55       $     $     $     $     $     $ (1.55 )             $  
 
                                                                     
Net income (loss)
            $ 1.82       $ 0.24     $ 0.11     $ 0.08     $ 0.11     $ 0.03     $ (1.55 )             $ 0.85  
 
                                                                     
 
                                                                                     
Net income (loss) per share-diluted:
                                                                                     
Income (loss) from continuing operations, net of tax
            $ 0.27       $ 0.24     $ 0.11     $ 0.08     $ 0.11     $ 0.03     $               $ 0.82  
Income (loss) from discontinued operations, net of tax
            $ 1.49       $     $     $     $     $     $ (1.49 )             $  
 
                                                                     
Net income (loss)
            $ 1.76       $ 0.24     $ 0.11     $ 0.08     $ 0.11     $ 0.03     $ (1.49 )             $ 0.82  
 
                                                                     
 
                                                                                     
Weighted average shares outstanding:
                                                                                     
Basic
              259,245         259,245       259,245       259,245       259,245       259,245       259,245                 259,245  
Diluted
              268,513         268,513       268,513       268,513       268,513       268,513       268,513                 268,513  
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme Corporation for the applicable period. We believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’s past financial performance and its prospects for the future. The Non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators management uses for planning and forecasting purposes and measuring the company’s performance. Such Non-GAAP financial measures should not be considered in isolation or used as a substitute for GAAP. Earnings per share are calculated as net income (loss) divided by weighted average shares outstanding. Therefore, earnings per share may not add across due to rounding.
(2) Discontinued Operations represents the operations of Genzyme Genetics and Genzyme Diagnostics, net of tax.


 

GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
For the Year Ended December 31, 2009
(Amounts in thousands, except percentage and per share data)
REVISED FOR DISCONTINUED OPERATIONS — UNAUDITED
                                                               
                        Bayer     Stock                
      GAAP       Acquisition     Compensation     Discontinued          
      As Reported       Related     Expense     Operations(2)       NON-GAAP(1)  
                   
Income Statement Classification:
                                                             
Total revenues
            $ 3,977,288       $     $     $               $ 3,977,288  
Cost of products and services sold
            $ (1,070,347 )     $ 36,822     $ 22,273     $               $ (1,011,252 )
 
                                                   
Gross margin
      73 %   $ 2,906,941       $ 36,822     $ 22,273     $         75 %   $ 2,966,036  
Selling, general and administrative
            $ (1,244,398 )     $     $ 100,741     $               $ (1,143,657 )
Research and development
            $ (833,853 )     $     $ 60,118     $               $ (773,735 )
Amortization of intangibles
            $ (253,507 )     $     $     $               $ (253,507 )
Contingent consideration expense
            $ (65,584 )     $ 65,584     $     $               $  
Gains (losses) on investments in equity securities
            $ (57 )     $     $     $               $ (57 )
Gain on acquisition of business
            $ 24,159       $ (24,159 )   $     $               $  
Other
            $ (1,646 )     $     $     $               $ (1,646 )
Investment income
            $ 17,642       $     $     $               $ 17,642  
                   
Summary:
                                                             
Income (loss) from continuing operations before income taxes
            $ 549,697       $ 78,247     $ 183,132     $               $ 811,076  
(Provision for) benefit from income taxes
      22.33 %   $ (122,766 )     $ (29,780 )   $ (46,987 )   $         24.60 %   $ (199,533 )
 
                                                   
Income (loss) from continuing operations
            $ 426,931       $ 48,467     $ 136,145     $               $ 611,543  
Income (loss) from discontinued operations, net of tax
            $ (4,631 )     $     $     $ 4,631               $  
 
                                                   
Net income (loss)
            $ 422,300       $ 48,467     $ 136,145     $ 4,631               $ 611,543  
 
                                                   
Net income (loss) per share-basic:
                                                             
Income (loss) from continuing operations, net of tax
            $ 1.59       $ 0.18     $ 0.51     $               $ 2.27  
Income (loss) from discontinued operations, net of tax
            $ (0.02 )     $     $     $ 0.02               $  
Net income (loss)
            $ 1.57       $ 0.18     $ 0.51     $ 0.02               $ 2.27  
 
                                                   
 
                                                             
Net income (loss) per share-diluted:
                                                             
Income (loss) from continuing operations, net of tax
            $ 1.56       $ 0.18     $ 0.50     $               $ 2.23  
Income (loss) from discontinued operations, net of tax
            $ (0.02 )     $     $     $ 0.02               $  
Net income (loss)
            $ 1.54       $ 0.18     $ 0.50     $ 0.02               $ 2.23  
 
                                                   
 
                                                             
Weighted average shares outstanding:
                                                             
Basic
              268,841         268,841       268,841       268,841                 268,841  
Diluted
              274,071         274,071       274,071       274,071                 274,071  
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme Corporation for the applicable period. We believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’s past financial performance and its prospects for the future. The Non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators management uses for planning and forecasting purposes and measuring the company’s performance. Such Non-GAAP financial measures should not be considered in isolation or used as a substitute for GAAP. Earnings per share are calculated as net income (loss) divided by weighted average shares outstanding. Therefore, earnings per share may not add across due to rounding.
(2) Discontinued Operations represents the operations of Genzyme Genetics and Genzyme Diagnostics, net of tax.


 

GENZYME CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP EARNINGS
For the Three Months Ended December 31, 2009
(Amounts in thousands, except percentage and per share data)
REVISED FOR DISCONTINUED OPERATIONS — UNAUDITED
                                                               
                        Bayer     Stock                
      GAAP       Acquisition     Compensation     Discontinued          
      As Reported       Related     Expense     Operations(2)       NON-GAAP(1)  
                   
Income Statement Classification:
                                                             
Total revenues
            $ 938,290       $     $     $               $ 938,290  
Cost of products and services sold
            $ (296,136 )     $ 19,082     $ 7,388     $               $ (269,666 )
 
                                                   
Gross margin
      68 %   $ 642,154       $ 19,082     $ 7,388     $         71 %   $ 668,624  
Selling, general and administrative
            $ (340,374 )     $     $ 21,767     $               $ (318,607 )
Research and development
            $ (224,918 )     $     $ 13,657     $               $ (211,261 )
Amortization of intangibles
            $ (70,237 )     $     $     $               $ (70,237 )
Contingent consideration expense
            $ (28,297 )     $ 28,297     $     $               $  
Gains (losses) on investments in equity securities
            $ 1,276       $     $     $               $ 1,276  
Other
            $ 700       $     $     $               $ 700  
Investment income
            $ 3,605       $     $     $               $ 3,605  
                   
 
                                                             
Summary:
                                                             
Income (loss) from continuing operations before income taxes
            $ (16,091 )     $ 47,379     $ 42,812     $               $ 74,100  
(Provision for) benefit from income taxes
      233.72 %   $ 37,608       $ (22,232 )   $ (11,391 )   $         -5.38 %   $ 3,985  
 
                                                   
Income (loss) from continuing operations
            $ 21,517       $ 25,147     $ 31,421     $               $ 78,085  
Income (loss) from discontinued operations, net of tax
            $ 1,728       $     $     $ (1,728 )             $  
 
                                                   
Net income (loss)
            $ 23,245       $ 25,147     $ 31,421     $ (1,728 )             $ 78,085  
 
                                                   
 
                                                             
Net income (loss) per share-basic:
                                                             
Income (loss) from continuing operations, net of tax
            $ 0.08       $ 0.09     $ 0.12     $               $ 0.29  
Income (loss) from discontinued operations, net of tax
            $ 0.01       $     $     $ (0.01 )             $  
 
                                                   
Net income (loss)
            $ 0.09       $ 0.09     $ 0.12     $ (0.01 )             $ 0.29  
 
                                                   
 
                                                             
Net income (loss) per share-diluted:
                                                             
Income (loss) from continuing operations, net of tax
            $ 0.08       $ 0.09     $ 0.12     $               $ 0.29  
Income (loss) from discontinued operations, net of tax
            $ 0.01       $     $     $ (0.01 )             $  
 
                                                   
Net income (loss)
            $ 0.09       $ 0.09     $ 0.12     $ (0.01 )             $ 0.29  
 
                                                   
 
                                                             
Weighted average shares outstanding:
                                                             
Basic
              265,596         265,596       265,596       265,596                 265,596  
Diluted
              270,241         270,241       270,241       270,241                 270,241  
Notes:
(1) Represents the Non-GAAP results of operations for Genzyme Corporation for the applicable period. We believe that certain Non-GAAP financial measures, when considered together with the GAAP figures, can enhance the overall understanding of the company’s past financial performance and its prospects for the future. The Non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the trends underlying our operating results and financial position and are among the primary indicators management uses for planning and forecasting purposes and measuring the company’s performance. Such Non-GAAP financial measures should not be considered in isolation or used as a substitute for GAAP. Earnings per share are calculated as net income (loss) divided by weighted average shares outstanding. Therefore, earnings per share may not add across due to rounding.
(2) Discontinued Operations represents the operations of Genzyme Genetics and Genzyme Diagnostics, net of tax.