“We made great progress during 2008 in a number of areas,” said chief executive officer Henri A. Termeer. “We delivered strong financial results, continued to grow our existing products, secured new product approvals, advanced pivotal clinical trials, and significantly strengthened our late-stage pipeline.”
Termeer today detailed Genzyme’s outlook for continued strong growth in 2009 and the catalysts that will drive near and long-term momentum. This year, the company expects to:
Obtain regulatory approvals for larger-scale production of Myozyme(alglucosidase alfa), which will help enable Genzyme to meet the rapidly increasing demand for the treatment, and provide capacity for the realization of the product’s significant long-term potential.
Launch Mozobil (plerixafor injection) in the US and Europe, and Clolar (clofarabine) for adult acute myelogenous leukemia in the United States, substantially expanding the company’s hematologic oncology presence.
Obtain US approval of a label expansion for Renvela® (sevelamer carbonate) to include the treatment of patients with chronic kidney disease who are not on dialysis, as well as E.U. approval of the treatment, significantly increasing the product’s market size and long-term growth potential.
Move key late-stage products forward by completing a pivotal study of mipomersen in homozygous familial hypercholesterolemia; advancing pivotal studies of alemtuzumab for MS; initiating pivotal studies of an oral therapy for Gaucher disease; and advancing late-stage studies of Prochymal for graft vs. host disease and PTC124 for Duchenne muscular dystrophy.
Delivering Sustainable Growth
Genzyme is on track to meet its goal of 20 percent compound average non-GAAP earnings growth from 2006 through 2011. For 2009, the company expects non-GAAP earnings to increase to approximately $4.70 per diluted share. Revenues for 2009 are expected to be between $5.2 and $5.4 billion. Non-GAAP earnings are projected to rise to approximately $7.00 per diluted share by 2011, and revenue that year is expected to reach $7 billion. Genzyme expects a total of 16 new regulatory approvals from 2009 through 2012, which will contribute to the company’s growth beyond 2011.
Genzyme currently has 12 number one products and has built its leadership role by pioneering a patient-focused, personalized medicine approach. This begins with clearly identified patient populations that have serious unmet medical needs, combined with the development of effective therapeutics, resulting in high-value products that become the standard of care.
The company has built a broad global infrastructure, with its products available in approximately 100 countries, 17 manufacturing sites in 9 countries, and more than 50 percent of its revenues coming from outside the United States. The geographic diversification of Genzyme’s commercial and manufacturing operations provides competitive advantages and enables the company to manage the impact of exchange rate fluctuations. Genzyme has no debt and generates more than $1 billion in cash annually. The company utilizes this cash flow to make substantial investments in its global infrastructure, to repurchase shares and to complete strategic transactions.
2008 Performance & Long-Term Business Outlook
The genetic disease segment has formed the core of Genzyme’s business to date, and the growth potential for this segment remains strong. Genzyme expects sales of enzyme replacement therapy products to grow at a compound average of approximately 15% over the five-year period from 2006-2011. At the same time, the emerging franchises of Genzyme’s portfolio are expected to make an increasingly greater contribution to the company’s growth, underscoring the beneficial impact of diversification. Revenue from these emerging franchises is expected to grow at a compound average of approximately 19% from 2006-2011.