Continuing its strong earnings for 2005, Genzyme Corp. reported a 24 percent jump in revenues for the third quarter due to significant sales growth across all of its product areas.
The Cambridge, Mass.-based company brought in revenues of $708.1 million for the three months ending Sept. 30, up from $569.2 million for the same quarter in 2004. Analysts had projected revenue of $699.15 million. The company's non-GAAP net income was $160.5 million, or 61 cents per share, beating consensus estimates of 58 cents per share.
It was an "absolutely excellent quarter," Genzyme's Chairman and CEO Henri Termeer said during a conference call. "It's very clear now that we will end the year well on the high end of our guidance."
GAAP net income was $115.7 million, or 43 cents per share, compared to last year's figures of $97.8 million, or 41 cents per share. GAAP income includes pretax charges of $50.8 million for amortization, and $12.7 million associated with the acquisition of Bone Care International Inc. (See BioWorld Today, May 5, 2005.)
Termeer attributed the growth to the increasing sales of its top products, including Renagel and Fabrazyme, as well as the company's expansion. Since 2003, Genzyme has "fundamentally transformed" itself by focusing on product diversification, manufacturing and reaching new global markets.
On the manufacturing end, Genzyme is building up its infrastructure to handle manufacturing all of its products. Last month, it opened a new manufacturing plant in Belgium for the production of Campath and other monoclonal antibodies and proteins, and it has finished expanding its Allston Landing facility to manufacture Myozyme, expected to launch next year.
"We have a presence in Japan," Termeer said, and the company is working to gain a foothold in China, looking at the Shanghai and Beijing markets.
"We're also looking to become an active participant in the Indian market," he added.
Product sales for the quarter were in line with expectations, reported Bear, Stearns & Co., of New York, with the exception of Hectorol, a vitamin D2 product gained through the acquisition of Madison, Wis.-based Bone Care International. Hectorol (doxercalciferol) is approved to treat secondary hyperparathyroidism in patients on dialysis, and those with earlier stages of chronic kidney disease. Third-quarter sales totaled $14.1 million.
Genzyme completed the $600 million Bone Care transaction during the third quarter, and began reducing product inventory levels for Hectorol, while working to establish arrangements with wholesale distributors of Hectorol, as it did earlier with its own renal disease drug, Renagel. Once those arrangements are in place, analysts said, Hectorol sales should begin increasing. The company already beefed up its sales force to reach both the end-stage renal disease and chronic kidney disease markets.
Sales of Renagel, the centerpiece of Genzyme's renal disease focus, increased by 15 percent during the third quarter with revenues of $106.9 million, compared to $93.3 million during the same quarter in 2004. Renagel (sevelamer hydrochloride) is a phosphate binder for patients with end-stage renal disease who are on hemodialysis.
Genzyme's therapeutics all grew in the third quarter. Fabrazyme (agalsidase beta), an enzyme-replacement therapy for Fabry's disease, recorded sales of $79.1 million, a 36 percent increase over sales of $58 million one year ago. Sales of Cerezyme (imiglucerase for injection) for Type I Gaucher's disease were $238.3 million, a 14 percent increase over the $208.4 million last year. And the company's enzyme-replacement therapy for MPS I, Aldurazyme (laronidase), which reported sales of $10.3 million during the third quarter of 2004, nearly doubled to $20.1 million.
Genzyme's biosurgery drug, Synvisc more than doubled its revenue from a year ago, from $24.6 million last year to $57.7 million this year. Synvisc is a viscosupplementation product for the treatment of knee pain due to osteoarthritis.
Transplant drugs Thymoglublin (antithymocyte globulin, rabbit) and Lymphoglobuline (antithymocyte globulin, equine) increased 14 percent for a combined total of $32.4 million, up from sales of $28.3 million during the third quarter a year ago.
The company's diagnostic and genetics business reported sales of $87.4 million, a 9 percent increase over the $77.6 million for the same period last year. In that area, Genzyme recently launched a lab test for epidermal growth factor receptor mutations associated with non-small-cell lung cancer that is designed to identify patients likely to respond to treatments.
Oncology revenue for the quarter totaled $12.2 million. That figure includes profits and royalties from Campath, which is marketed by Berlin-based Schering-Plough AG to treat B-cell chronic lymphocytic leukemia. The companies expect to begin a Phase III trial next year to evaluate Campath in multiple sclerosis. Results from an interim Phase II analysis showed the drug to have a large treatment effect in comparison with Rebif (interferon beta-1a) from Geneva-based Serono SA.
For the third quarter, overall research and development expenses grew 18 percent over last year, from $92.2 million to $128 million. In addition to Myozyme, which is before the U.S. and European regulatory agencies for approval in Pompe disease, the company has an ongoing pivotal trial of hylastan, a next-generation viscosupplementation product to treat osteoarthritic pain, and expects to begin Phase III work with DX-88, in development for hereditary angiodema with Cambridge, Mass.-based Dyax Corp.
As of Sept. 30, it had about $950 million in cash and marketable securities.