July 15, 2004
GENZYME RECORDS STRONG REVENUE GROWTH IN SECOND QUARTER, DRIVEN BY FABRAZYME, RENAGEL SALES
Genzyme Corp. recognized a 58 percent increase in revenue in the second quarter of 2004, driven by strong gains in sales of its pharma name Fabrazyme (agalsidase beta) Fabry disease therapy and its Renagel (sevelamer hydrochloride), which is used to control serum phosphorus levels in patients with kidney disease.
Overall revenue in the quarter reached $549.6 million, up from the $347.7 million achieved in the comparable period of last year. Fabrazyme sales more than tripled from $15.4 million in the prior-year period to $49.6 million, while Renagel sales jumped 33 percent in the quarter to $87.6 million.
For the full year, Genzyme now expects to generate revenue in the range of $2.07 to $2.19 billion.
The company's net income in this year's second quarter totaled $78.2 million, or $0.34 per diluted share, compared with $70.8 million, or $0.32 per share, in the second quarter of 2003. Excluding special items and amortization, net income rose 36 percent to $102.2 million, or $0.44 per share, compared with $75.3 million, or $0.34 per share,
For fiscal 2004, Genzyme expects to report earnings on a Generally Accepted Accounting Principles basis of between $1.35 and $1.40 per share. Non-GAAP earnings are anticipated to be in the range of $1.65 to $1.75 per share.
Genzyme said the guidance reflects six months of the anticipated impact of its merger with ILEX Oncology Inc., which is expected to close this summer.
"Genzyme had a very strong first two quarters and is moving forward into the second half of the year with significant momentum," said Henri Termeer, Genzyme's chief executive. "The strength of our top and bottom lines continues to allow us to build and diversify the company by investing in [research and development] and completing transactions that add important programs."
Genzyme shares closed at $50.00, up $5.50, or 12.4 percent, in heavy trading on the Nasdaq.
April 16, 2004
GENZYME REPORTS GAINS IN Q1 REVENUE, EARNINGS, DRIVEN BY GROWTH OF KEY THERAPIES
Genzyme Corp. reported increases in revenue and earnings for the first quarter of 2004, aided by strong growth in sales of its key pharma name therapies.
For the period, the company generated $491.3 million in revenue, up from $314 million in the same period of last year. Genzyme's net income in the first quarter totaled $67.9 million, or $0.29 per diluted share, compared with $61.9 million, or $0.28 per share, in the prior-year quarter.
Excluding special items and amortization, the company achieved net income of $85.6 million, or $0.37 per share, compared with $68 million, or $0.31 per share, in the first quarter of 2002. Special items included a $1.8 million charge associated with the sale of inventory acquired from SangStat Medical Corp., while amortization charges associated with the acquisitions of SangStat and Alfigen Inc. totaled $26.2 million
During the quarter, Genzyme benefited from sales growth for three of its key drugs. Sales of enzyme replacement therapy Cerezyme (imiglucerase) for type 1 Gaucher disease totaled $203 million, a 21 percent increase from $167.2 million in 2003. Renagel (sevelamer hydrochloride), indicated to control serum phosphorus levels in patients with kidney disease, generated $83.5 million in sales, up 42 percent from $58.8 million in the comparable period of the previous year, while revenue from sales of the Fabry disease treatment Fabrazyme (agalsidase beta) totaled $38.1 million compared with $11.8 million for the pharmaceutical brand in the first quarter of 2003.
Genzyme said it expects to earn between $0.32 and $0.34 per share in the second quarter on a Generally Accepted Accounting Principles basis. Excluding $26.2 million in amortization charges, earnings are anticipated to be in the range of $0.39 to $0.41 per share.
Genzyme shares closed at $46.64, down $0.28, or 0.6 percent, in heavy Nasdaq trading.
April 25, 2003
FDA GRANTS MARKETING APPROVAL FOR FIRST FABRY DISEASE TREATMENT
Shares of Genzyme Corp. soared 8.3 percent after the Food and Drug Administration approved the company's Fabry disease treatment Fabrazyme (agalsidase beta).
Fabrazyme will receive seven years of market exclusivity under the orphan drug rule, which was enacted by the government to encourage companies to develop drugs for rare disorders.
Genzyme said that Fabrazyme is the first treatment approved in the United States for people with Fabry disease.
Fabry disease is caused by a deficiency of an enzyme that leads to a build-up of fat deposits within cells of the kidneys, heart and other organs, subsequently causing pain and often death. Genzyme's agent is injected in patients in order to replace the deficient enzyme.
The drug was approved under the FDA's accelerated approval process, which was established for serious or life-threatening disorders. Approval can be granted under this program if studies show early favorable outcomes that are likely to predict clinical benefit.
As a requirement for accelerated approval, the Cambridge, Mass.-based company is conducting an ongoing Phase IV trial involving 70 patients, with the aim of demonstrating that Fabrazyme measurably improves kidney function.
Genzyme shares closed at $39.38, up $3.00, in heavy trading on the Nasdaq.
Transkaryotic Therapies Inc. is also seeking FDA approval for an enzyme replacement therapy, Replagal (agalsidase alfa), intended to treat Fabry disease. TKT shares closed at $5.59, down $0.88, or 13.6 percent, in heavy trading on the Nasdaq.
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