EX-99.3 5 a2108628zex-99_3.htm EXHIBIT 99.3
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Exhibit 99.3

For Immediate Release
April 16, 2003
  Media Contact
Maria Foley
617-591-5690
  Investor Contact
Carol Miceli
617-761-8935


Genzyme Molecular Oncology Reports First Quarter 2003 Results
Kidney Cancer Clinical Trial Enrolling Patients/Treatment Underway

        FRAMINGHAM, Mass.—Genzyme Corp. today reported first quarter financial results for its Genzyme Molecular Oncology division (Nasdaq:GZMO).

        Revenues to Genzyme Molecular Oncology for the first quarter of 2003 were $2.2 million, down from $2.4 million in the first quarter of 2002.

        Expenditures on total research and development, including collaborator-funded expenses, were $5.4 million ($4.2 million in research and development and $1.2 million in collaborator-funded research) for the first quarter, down from $6.4 million ($5.3 million in research and development and $1.1 million in collaborator-funded research) in the first quarter of 2002.

        The decrease reflects Genzyme Molecular Oncology's planned reduction in research and development activities in order to manage its cash position. The division is focused on pursuing only the programs that it believes have the most potential for product commercialization and valuable collaborations.

        Net loss allocated to Genzyme Molecular Oncology stock for the first quarter of 2003 was $4.8 million, or $0.28 per share, compared to a net loss of $6.0 million, or $0.36 per share, for the first quarter of 2002.

        "We are managing our finances very closely, while we continue to advance our clinical programs and engage in partnering discussions," stated Gail Maderis, president, Genzyme Molecular Oncology. "We are maintaining good momentum and are on track to achieve our projected milestones this year."

        Genzyme Molecular Oncology ended the first quarter with $6.8 million in cash and marketable securities. It also has access to $11 million through its financing arrangement with Genzyme General and additional funding through Genzyme Corporation's revolving credit facility.

Progress in the Clinic

        Genzyme Molecular Oncology expects to complete patient enrollment by the end of the summer in its ongoing Phase I/II clinical trial in advanced kidney cancer. This trial uses a patient-specific, electrofusion vaccine approach. Up to twenty patients will be enrolled in the multi-center trial. Genzyme Molecular Oncology expects that a majority of patients will complete their treatment in the trial by the end of the year.

        Genzyme Molecular Oncology announced data last month from its Phase I/II patient-specific clinical trials in melanoma and kidney cancer. Data from its breast cancer trial was announced last December. These studies used a chemical fusion approach to produce the therapeutic vaccine. The aggregate data established that the vaccine could induce measurable clinical and immunologic reactions following vaccination in a small group of patients, with mild side-effects or toxicity.

        In keeping with its selective approach to clinical development, Genzyme Molecular Oncology will evaluate these data, along with findings from the electrofusion study, to determine if either has significant commercial potential. Similarly, it will evaluate data from its two antigen-specific clinical trials in melanoma to determine future direction with this approach.

        Positive final data were reported by Genzyme Molecular Oncology earlier this year from its ex vivo study in melanoma. Data from its in vivo clinical trial is now being analyzed and is expected to be announced at the spring meeting of the American Society of Clinical Oncology.



Program Updates

        Genzyme Molecular Oncology received U.S. patent protection in the first quarter of 2003 covering a novel peptide discovered using its proprietary SPHERE™ (Solid Phase Epitope Recovery) screening technology. This peptide has potential application in the treatment of breast and ovarian cancers, and could be used as an active immunotherapy that attacks and destroys cancer cells expressing the HER-2 antigen.

        Genzyme Molecular Oncology also continues research on its first group of patented SPHERE peptides directed at melanoma, with the expectation of moving them into the clinic next year. Three U.S. patents have now been issued related to SPHERE, covering the method and various, novel peptides.

        Genzyme Molecular Oncology is making strong progress in advancing its antigen discovery collaboration with Purdue Pharma. More than three dozen candidate antigens that are prevalent across a variety of cancer indications have now been presented to Purdue for consideration. Purdue has chosen several of these antigens for validation and launched a formal program to advance specific ones from this group into preclinical research.

        Genzyme Molecular Oncology's advances in its discovery and antiangiogenesis programs were to have been highlighted at the American Association of Cancer Research (AACR) meeting that was cancelled earlier this month due to concern regarding severe acute respiratory syndrome (SARS). Genzyme Molecular Oncology was scheduled to present eight posters at the conference illustrating the strength of these programs. Among those to be featured was a poster unveiling six previously unknown antigens that lie in biological pathways regarded to be important in cancer.

        Genzyme Molecular Oncology and its antiangiogenesis research collaborator, Kirin Brewery of Japan, also were to present several posters at AACR highlighting their work with tumor endothelial markers, or TEMs. This research illustrates that tumor blood vessels are unique from normal vasculature and highlights the importance of the TEMs as targets. Genzyme Molecular Oncology's research in this area has also yielded new targets and new model systems that are more representative of human disease for use in developing therapeutic agents to treat cancer.

        "We're very excited about the progress we are making in our antiangiogenesis research," stated Maderis. "We are seeing biologic activity in some of our TEMs, and are on track to achieve research milestones from Kirin and select an antibody as a clinical candidate before the end of the year. We also have fifteen targets not included in this collaboration that are in various stages of validation."

        AACR is currently investigating whether the cancelled conference will be rescheduled. Genzyme Molecular Oncology is awaiting guidance from the organization before deciding how to release data from its eight posters.

About Genzyme Molecular Oncology

        Genzyme Molecular Oncology is developing a new generation of cancer products focusing on cancer vaccines and angiogenesis inhibitors. It is shaping these new therapies through the integration of its genomics, gene and cell therapy, small-molecule drug discovery, and protein therapeutic capabilities. Genzyme Molecular Oncology is a division of Genzyme Corporation. For more information on Genzyme Molecular Oncology, please visit its website at www.genzymemolecularoncology.com

        This press release contains forward-looking statements, including the statements regarding Genzyme Molecular Oncology's ability to meet its projected milestones for the year; the time at which patient enrollment and treatment in the patient-specific, electrofusion vaccine trial will be completed; the reporting of clinical data from the antigen-specific, in vivo vaccine trial; the application of SPHERE peptides in making clinically-relevant cancer vaccines and the initiation of clinical trials of the

2



melanoma SPHERE peptides; and the ability to achieve research milestones from Kirin and the selection of an antibody candidate under the Kirin collaboration. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the ability to attract, enroll and successfully treat patients in the patient-specific, electrofusion vaccine trial and the ability to manufacture sufficient supply of product, the actual timing for data analysis and presentation for the antigen-specific, in vivo vaccine trial; the results of research and preclinical activities directed to the SPHERE peptides and the content and timing of decisions made by the FDA regarding the clinical development of these peptides; the ability to develop successfully an active immunotherapy product using SPHERE peptides; the results and timing of research activities under the Kirin collaboration; and the factors contained under the caption "Factors Affecting Future Operating Results" in Exhibit 99.2 to Genzyme Corporation's 2002 Annual Report on Form 10-K. Genzyme Molecular Oncology Division common stock is a series of common stock of Genzyme Corporation. Therefore, holders of Genzyme Molecular Oncology Division common stock are subject to all of the risks and uncertainties described in those reports. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and we undertake no obligation to update or revise the statements.

        Genzyme® is a registered trademark and SPHERE is a trademark of Genzyme Corporation. All rights reserved.

# # #

Conference Call Information

        There will be a conference call today at 1:00 p.m. ET to discuss Genzyme Molecular Oncology's first quarter financial results. If you would like to participate in the call, please dial 719-457-2642. A replay of this call will be available from 3:00 p.m. ET through midnight on April 23 by dialing 719-457-0820. Please reference reservation number 249502. This call will also be webcast live over the Internet at http://www.genzyme.com/corp/investors/events_home.asp

Upcoming Events

        Genzyme Corporation will report second quarter 2003 financial results on July 16. If you would like to participate in any of these calls, please dial 719-457-2642 at 11:00 a.m. for Genzyme General, at 1:00 p.m. for Genzyme Molecular Oncology, and 3:00 p.m. for Genzyme Biosurgery. There is no passcode necessary. Please refer to www.genzyme.com one week prior to the financial reporting date for any updates to this information. These calls will also be webcast live over the Internet at http://www.genzyme.com/corp/investors/events_home.asp

        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 1-703-797-1866 outside the United States.

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GENZYME MOLECULAR ONCOLOGY (A Division of Genzyme Corporation)

Combined Statements of Operations

(Unaudited, amounts in thousands, except per share amounts)

 
  Three Months Ended
March 31,

 
 
  2003
  2002
 
Total revenues   $ 2,188   $ 2,422  
Operating costs and expenses:              
Cost of revenues     1,172     1,254  
Selling, general and administrative     1,734     2,069  
Research and development     4,191     5,298  
   
 
 
Total operating costs and expenses     7,097     8,621  
   
 
 
Operating loss     (4,909 )   (6,199 )
   
 
 
Other income (expenses):              
Interest income     114     188  
Interest expense     (20 )   (20 )
   
 
 
Total other income (expenses)     94     168  
   
 
 
Division net loss and net loss allocated to Molecular Oncology Stock   $ (4,815 ) $ (6,031 )
   
 
 
Net loss per share of Molecular Oncology Stock—basic and diluted   $ (0.28 ) $ (0.36 )
   
 
 
Weighted average shares outstanding     16,939     16,763  
   
 
 


Condensed Combined Balance Sheets
(Unaudited, amounts in thousands)

 
  March 31,
2003

  December 31, 2002
Cash and all marketable securities   $ 6,751   $ 13,112
Other current assets     661     843
Equipment, net     16     26
   
 
Total assets   $ 7,428   $ 13,981
   
 
Current liabilities   $ 8,670   $ 10,427
Division equity     (1,242 )   3,554
   
 
Total liabilities and division equity   $ 7,428   $ 13,981
   
 

Genzyme Molecular Oncology (A Division of Genzyme Corporation)
Analyst Schedule
(Unaudited, amounts in thousands, except percentage and per share amounts)

 
  Q1-02
  Q2-02
  Q3-02
  Q4-02
  Q1-03
  Q1-03
vs.
Q1-02
% B/(W)

  FY 2001
  FY 2002
  YTD 3/31/03
 
Total revenues   $ 2,422   $ 2,346   $ 2,282   $ 2,339   $ 2,188   (10 %) $ 6,562   $ 9,389   $ 2,188  
Gross profit     1,168     1,011     1,131     1,224     1,016   (13 %)   3,486     4,534     1,016  
SG&A expense     2,069     2,124     1,746     1,463     1,734   16 %   7,552     7,402     1,734  
R&D expense     5,298     5,323     5,876     5,060     4,191   21 %   26,540     21,557     4,191  
   
 
 
 
 
 
 
 
 
 
Operating loss     (6,199 )   (6,436 )   (6,491 )   (5,299 )   (4,909 ) 21 %   (30,606 )   (24,425 )   (4,909 )
Other income (expenses):                                                      
  Interest income     188     219     206     178     114   (39 %)   945     791     114  
  Interest expense     (20 )   (20 )   (20 )   (20 )   (20 ) 0 %   (57 )   (80 )   (20 )
   
 
 
 
 
 
 
 
 
 
Loss before income taxes     (6,031 )   (6,237 )   (6,305 )   (5,141 )   (4,815 ) 20 %   (29,718 )   (23,714 )   (4,815 )
Tax benefit                                      
   
 
 
 
 
 
 
 
 
 
Net loss allocated to Molecular Oncology Stock   $ (6,031 ) $ (6,237 ) $ (6,305 ) $ (5,141 ) $ (4,815 ) 20 % $ (29,718 ) $ (23,714 ) $ (4,815 )
   
 
 
 
 
 
 
 
 
 
Net loss per share of Molecular Oncology Stock—basic and diluted   $ (0.36 ) $ (0.37 ) $ (0.37 ) $ (0.30 ) $ (0.28 ) 22 % $ (1.82 ) $ (1.41 ) $ (0.28 )
   
 
 
 
 
 
 
 
 
 
Weighted average shares outstanding     16,763     16,801     16,847     16,897     16,939   1 %   16,350     16,827     16,939  
   
 
 
 
 
 
 
 
 
 

Genzyme Molecular Oncology (A Division of Genzyme Corporation)
Analyst Schedule
(Unaudited, amounts in thousands, except percentage amounts)

 
  Q1-02
  Q2-02
  Q3-02
  Q4-02
  Q1-03
  FY 2001
  FY 2002
  YTD 3/31/03
 
Total revenues   $ 2,422   $ 2,346   $ 2,282   $ 2,339   $ 2,188   $ 6,562   $ 9,389   $ 2,188  
Gross margin     48 %   43 %   50 %   52 %   46 %   53 %   48 %   46 %
SG&A expense as % of total revenue     85 %   91 %   77 %   63 %   79 %   115 %   79 %   79 %
R&D expense as % of total revenue     219 %   227 %   257 %   216 %   192 %   404 %   230 %   192 %
Operating loss as % of total revenue     (256 %)   (274 %)   (284 %)   (227 %)   (224 %)   (466 %)   (260 %)   (224 %)
 
  Q1-02
  Q2-02
  Q3-02
  Q4-02
  Q1-03
  FY 2001
  FY 2002
  Q1-03
 
Other selected financial data:                                                  
  Cash and all marketable securities   $ 32,564   $ 25,477   $ 18,021   $ 13,112   $ 6,751   $ 41,135   $ 13,112   $ 6,751  
  Working capital     11,337     (271 )   8,846     3,528     (1,258 )   28,807     3,528     (1,258 )
  Equipment, net     88     59     38     26     16     119     26     16  
  Total assets     33,315     26,157     18,460     13,981     7,428     42,419     13,981     7,428  
  Division equity     20,694     14,809     8,693     3,554     (1,242 )   26,813     3,554     (1,242 )


GENZYME CORPORATION

Consolidated Statements of Operations

(Unaudited, amounts in thousands, except per share amounts)

 
  Three Months Ended
March 31,

 
 
  2003
  2002
 
Total revenues   $ 381,859   $ 297,940  
   
 
 
Operating costs and expenses:              
  Cost of products and services sold     111,812     87,172  
  Selling, general and administrative     114,224     102,958  
  Research and development     75,631     82,141  
  Amortization of intangibles     17,505     17,597  
   
 
 
      Total operating costs and expenses     319,172     289,868  
   
 
 
Operating income     62,687     8,072  
   
 
 
Other income (expenses):              
  Equity in net loss of unconsolidated affiliates     (4,194 )   (4,094 )
  Gain on investments in equity securities         166  
  Other     750     (864 )
  Investment income     11,614     13,437  
  Interest expense     (6,490 )   (6,806 )
   
 
 
      Total other income (expenses)     1,680     1,839  
   
 
 
Income before income taxes     64,367     9,911  
Provision income taxes     (18,998 )   (3,138 )
   
 
 
Net income (loss) before cumulative effect of change in accounting for goodwill     45,369     6,773  
Cumulative effect of change in accounting for goodwill (1)         (98,270 )
   
 
 
Net income (loss) (1)   $ 45,369   $ (91,497 )
   
 
 
Net income (loss) per share:              
  Allocated to Genzyme General Stock:              
    Genzyme General division net income   $ 57,793   $ 24,309  
    Tax benefit allocated from Genzyme Biosurgery     2,322     4,299  
    Tax benefit allocated from Genzyme Molecular Oncology     1,763     2,130  
   
 
 
    Net income allocated to Genzyme General Stock   $ 61,878   $ 30,738  
   
 
 
    Net income per share of Genzyme General Stock:              
      Basic   $ 0.29   $ 0.14  
   
 
 
      Diluted (2)   $ 0.28   $ 0.14  
   
 
 
    Weighted average shares outstanding:              
      Basic     215,091     213,332  
   
 
 
      Diluted (2)     220,432     221,064  
   
 
 
Allocated to Biosurgery Stock:              
  Genzyme Biosurgery net loss before cumulative effect of change in accounting for goodwill   $ (14,102 ) $ (20,382 )
  Cumulative effect of change in accounting for goodwill (1)         (98,270 )
   
 
 
  Genzyme Biosurgery division net loss     (14,102 )   (118,652 )
  Allocated tax benefit     2,408     2,448  
   
 
 
  Net loss allocated to Biosurgery Stock (1)   $ (11,694 ) $ (116,204 )
   
 
 
  Net loss per share of Biosurgery Stock—basic and diluted:              
    Net loss per share before cumulative effect of change in accounting for goodwill   $ (0.29 ) $ (0.46 )
    Per share cumulative effect of change in accounting for goodwill (1)         (2.48 )
   
 
 
  Net loss per share of Biosurgery Stock—basic and diluted (1)   $ (0.29 ) $ (2.94 )
   
 
 
  Weighted average shares outstanding     40,578     39,564  
   
 
 
Allocated to Molecular Oncology Stock:              
  Net loss   $ (4,815 ) $ (6,031 )
   
 
 
  Net loss per share of Molecular Oncology Stock-basic and diluted   $ (0.28 ) $ (0.36 )
   
 
 
  Weighted average shares outstanding     16,939     16,763  
   
 
 

(1)
Effective January 1, 2002, in connection with the provisions of SFAS No. 142, "Goodwill and Other Intangible Assets," we ceased amortizing goodwill. In connection with the adoption of SFAS No. 142, we tested the goodwill of our cardiothoracic reporting unit for impairment and, as a result, reduced goodwill by recording a cumulative effect impairment charge of $98.3 million in our consolidated statements of operations and the combined statements of operations of Genzyme Biosurgery for the three months ended March 31, 2002.
(2)
Net income per share allocated to Genzyme General Stock on a diluted basis and weighted average shares-diluted for both periods presented includes the dilutive effect of options, stock purchase rights and warrants, but excludes the effect of the convertible subordinated debentures allocated to Genzyme General as the effect would be anti-dilutive in each period.


GENZYME CORPORATION

Condensed Consolidated Balance Sheets

(Unaudited, amounts in thousands)

 
  March 31,
2003

  December 31,
2002

Cash and all marketable securities   $ 1,234,318   $ 1,195,004
Other current assets     693,277     676,231
Property, plant and equipment, net     831,040     802,448
Intangibles, net     1,309,049     1,326,553
Other assets     93,115     82,813
   
 
  Total assets   $ 4,160,799   $ 4,083,049
   
 
Current liabilities   $ 616,028   $ 607,800
Noncurrent liabilities     770,703     777,402
Stockholders' equity     2,774,068     2,697,847
   
 
  Total liabilities and stockholders' equity   $ 4,160,799   $ 4,083,049
   
 



QuickLinks

Genzyme Molecular Oncology Reports First Quarter 2003 Results Kidney Cancer Clinical Trial Enrolling Patients/Treatment Underway
GENZYME MOLECULAR ONCOLOGY (A Division of Genzyme Corporation) Combined Statements of Operations (Unaudited, amounts in thousands, except per share amounts)
Condensed Combined Balance Sheets (Unaudited, amounts in thousands)
GENZYME CORPORATION Consolidated Statements of Operations (Unaudited, amounts in thousands, except per share amounts)
GENZYME CORPORATION Condensed Consolidated Balance Sheets (Unaudited, amounts in thousands)