Delivers Solid Financial Performance While Building for the Future

CAMBRIDGE, Mass., July 23 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) today reported strong sales and profit growth in the second quarter, along with significant progress in its commercial and clinical programs.

Revenue increased 25 percent to approximately $1.171 billion from $933.4 million in last year's second quarter. The increase was driven by growth across all areas of the business.

GAAP net income was $69.6 million, or $0.25 per diluted share, compared with $83.8 million, or $0.31 per diluted share, in the second quarter a year ago. GAAP net income reflects the fee for the license to mipomersen, a highly promising cholesterol-lowering drug in late-stage development.

Non-GAAP net income increased to $268.5 million from $238.7 million in last year's second quarter. Non-GAAP earnings increased to $0.98 per diluted share from $0.88.

Genzyme continues to reinvest cash from operations to build a foundation for long-term growth. In the second quarter, the company generated approximately $329 million in cash from net income prior to one-time events and proceeds from the issuance of common stock. The company made a $175 million payment to Isis Pharmaceuticals to secure the rights to mipomersen, significantly strengthening its late-stage pipeline. Genzyme also invested approximately $130 million in capital projects, predominantly focused on expanding manufacturing capacity to meet current and anticipated product demand. To reduce the dilutive effect of equity compensation, the company used a portion of its cash to repurchase 1 million shares under its three-year stock buyback program.

'It was a strong and highly productive quarter,' said Henri A. Termeer, Genzyme's chairman and chief executive officer. 'We delivered solid financial results, set in place a number of catalysts that will drive near-term growth, and continued to build the company to grow beyond 2011.'

Over the next 12 months, Genzyme anticipates six potential approvals for new products or broader indications for existing products. These catalysts will provide significant near term momentum:

-- Genzyme expects FDA approval by the end of this year for alglucosidase alfa (Myozyme(R)) produced at the 2000L bioreactor scale, following the submission of a BLA on May 30. European approval of Myozyme produced at the 4000L scale is expected in the first half of next year.

-- The company anticipates that the labeling for Renvela(R) (sevelamer carbonate) will be expanded by mid-2009 to include the treatment of chronic kidney disease patients with elevated phosphorus levels who are not on dialysis. Genzyme, along with two other companies, submitted a position paper to the FDA in May regarding this expanded use of phosphate binders.

-- Genzyme also expects that the labeling for Clolar(R) (clofarabine) will be expanded by the middle of next year to include its use in treating adult patients with acute myelogenous leukemia. The company plans to file supplemental marketing applications this year to broaden Clolar's indication.

-- Genzyme expects to launch Mozobil(TM) (plerixafor) in the United States and Europe during the first half of next year, following regulatory approval. The company submitted marketing applications for the product last month. Mozobil is intended to enable patients with certain types of cancers to successfully receive a stem-cell transplantation.

-- FDA action on Genzyme's marketing application for Synvisc-ONE(R) (hylan G-F 20) is anticipated this year. The company submitted a response to the agency in June that included additional analysis and data requested in a November 2007 letter.

Genzyme continues to expect non-GAAP earnings for this year of approximately $3.90 per diluted share. GAAP earnings in 2008 are expected to be approximately $2.20 per diluted share. The GAAP estimate now reflects Genzyme's equity investment in Isis Pharmaceuticals, the mipomersen licensing fee, along with anticipated amortization, stock-compensation expenses and the effect of contingent convertible debt.

Second-Quarter Product Sales

Within the Therapeutics business, Myozyme revenue rose 65 percent compared with last year's second quarter, despite the constraint on U.S. sales resulting from the delay in approval of 2000L-scale production. Revenue increased to $77.2 million from $46.7 million in the same period a year ago. The FDA is expected to convene an advisory committee meeting in October to discuss the BLA for alglucosidase alfa produced at the 2000L-scale, as required for all new drug and biologics license applications under the FDA Amendments Act enacted last year. FDA approval of 2000L-scale production is needed to provide broader access to product for adult patients in the United States.

The launch of Myozyme has been more rapid than the launch of any of Genzyme's other treatments for lysosomal storage disorders, driven by faster than expected adoption by physicians and patients and consistent support from health authorities in more than 40 countries. To meet the global demand for Myozyme, Genzyme is working to secure approval of production at its 4000L bioreactor scale manufacturing plant in Belgium, which would significantly expand capacity. The company is conducting process validation runs for Myozyme produced at the 4000L-scale, which it expects to complete this year and subsequently file for EMEA approval. The company expects that European authorities will approve Myozyme production at the facility during the first half of 2009. Approval of 4000L-scale production in Belgium will be necessary to meet the anticipated global demand for Myozyme. Product supply in 2009 is expected to be particularly tight until the Belgium plant is approved.

Genzyme's other treatments for lysosomal storage disorders also continue to experience strong, double-digit growth. Second-quarter Cerezyme(R) (imiglucerase for injection) sales rose 13 percent to $319.4 million, compared with $283.0 million in the previous second quarter. Sales of Fabrazyme(R) (agalsidase beta) grew 21 percent, rising to $126.6 million from $104.3 million. Sales of Aldurazyme(R) (laronidase) increased 33 percent to $38.8 million, compared with $29.1 million in the second quarter last year when the product's sales were recorded under the joint venture with BioMarin Pharmaceutical Inc.

The company also reported preliminary results from a Phase 2 trial of its investigational oral therapy for Gaucher disease Genz-112638. The results were consistent with those observed for patients beginning enzyme replacement therapy, and they highlight the potential of this compound to provide a convenient treatment alternative for patients and a broader range of treatment options for physicians. Genzyme is developing protocols for two Phase 3 trials that it expects to initiate early next year.

Sales of Thyrogen(R) (thyrotropin alfa for injection) remained strong, increasing 34 percent to $39.4 million from $29.5 million. The use of Thyrogen in ablation procedures is contributing to the product's growth in the United States, while its growth in Europe is being driven by increasing diagnosis of thyroid cancer and its international adoption is being driven by expansion into new geographic markets.

Within the Renal business, sales of sevelamer therapies Renagel(R) (sevelamer hydrochloride) and Renvela grew 16 percent to $168.6 million from $144.9 million in the second quarter last year. Genzyme launched Renvela in the United States in March, and the product is now included in more than 85 percent of health plan formularies. Formulary access equal to that of Renagel is expected by the end of the third quarter, ahead of Genzyme's expectations.

Within the Transplant business, second-quarter sales of Thymoglobulin(R) (Anti-thymocyte Globulin [Rabbit]) and Lymphoglobuline(R) (Anti-thymocyte Globulin [Equine]) rose 10 percent to $45.6 million from $41.4 million in the second quarter last year. Worldwide demand for Thymoglobulin continues to grow, and Genzyme is working to build inventory to meet anticipated demand following resolution of a manufacturing issue during 2007 that affected product appearance in some lots. The company has begun construction of a new manufacturing plant for Thymoglobulin in France to support the long-term growth of the product.

Genzyme continues to prepare for the U.S. and European launch of Mozobil next year, and it is also planning to seek regulatory approvals globally. The company anticipates peak annual sales of Mozobil in the transplant setting of $400 million. More than 900 patients have already received the product through a compassionate use program in the United States, and similar compassionate use programs have recently begun in Europe. Genzyme continues to invest in studies exploring additional potential applications for Mozobil, including its use in conjunction with chemotherapy.

Within the Biosurgery business, sales of Synvisc(R) (hylan G-F 20) and Synvisc-ONE rose to $70.9 million from $64.9 million, an increase of 9 percent. The growth was driven by the increasing strength of Synvisc in the U.S. market and the initiation of direct sales of the product in Latin America. Genzyme is introducing Synvisc-ONE in a growing number of European and Southeast Asian countries.