Genzyme Corp. (NASDAQ: GENZ) reported that preliminary fourth-quarter revenue grew 23 percent to $1.15 billion from $938 million in the fourth quarter of 2009. For the year, revenue was $4.1 billion compared with $4.0 billion in 2009. Fourth-quarter revenue from the Personalized Genetic Health business grew 46 percent compared with the same period in 2009, and 26 percent from the third quarter of 2010. This growth reflects increasing supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta), and the U.S. launch of Lumizyme® (alglucosidase alfa).
Genzyme reported these and other preliminary, unaudited revenue figures in conjunction with a presentation by Chairman and Chief Executive Officer Henri A. Termeer at the J.P. Morgan 29th Annual Healthcare Conference in San Francisco. The company will provide full 2010 financial results and 2011 guidance on February 16.
Genzyme's fourth-quarter non-GAAP diluted earnings per share (EPS) is expected to be $0.80 - $0.85, approximately double the third quarter non-GAAP diluted EPS of $0.42. Fourth-quarter non-GAAP diluted EPS guidance was $0.90 - $0.95. Cerezyme revenue for the quarter was lower than anticipated and gross margins were reduced due to costs associated with manufacturing operation improvements. Cerezyme revenue was impacted by the delay of orders in Brazil; a late lot release that was exacerbated by shipping delays due to December weather issues in Europe; and the loss of a specific lot for Japan. Manufacturing operation costs were impacted by consent decree compliance measures, and expenses associated with the simultaneous start-up of three operations: the new Framingham plant, the fill/finish expansion in Waterford, and the transfer of fill/finish work to a third-party manufacturer.
Based on this run rate, Genzyme now expects non-GAAP diluted EPS of $4.10 - $4.35 in 2011 and approximately $5 billion in revenue, compared with previous guidance of $4.30 - $4.60 and $5.1 billion, respectively. EPS in the first quarter of 2011 is expected to be similar to the fourth quarter of 2010. For the three-year period from 2008 to 2011, the company expects the compound annual growth rate of its non-GAAP EPS to be approximately 30 percent.
"We achieved record revenue in the fourth quarter and approximately doubled our earnings from the third quarter, returning to pre-disruption levels experienced in the first half of 2009," said Mr. Termeer. "We expect to maintain this earnings level in the first quarter and grow from there beginning in the second quarter, as we continue to execute on the opportunities provided by our core businesses and reduce our operating expenses."
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 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; and fully supplying existing patient demand for Fabrazyme and receiving approval for the treatment's production at the new Framingham plant, both expected during the second half of 2011.
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, and diagnostic testing. 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.