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Strong Fourth Quarter for Genzyme Concludes Productive Year
Non-GAAP EPS Reaches $1.04 in Fourth Quarter and $4.00 for 2008 Company Provides Confident Outlook for 2009 Genzyme Corp. (NASDAQ: GENZ) today announced solid fourth-quarter revenue and earnings growth and provided guidance for 2009 that underscored its positive outlook for the year. GAAP net income rose to $86.7 million, or $0.31 per diluted share, compared with $78.9 million, or $0.29 per diluted share, in the prior fourth quarter. Non-GAAP net income increased 16 percent to $288.5 million compared with $249.2 million in the fourth quarter of 2007. Non-GAAP earnings rose 14 percent to $1.04 per diluted share from $0.91 per diluted share in the same period in 2007. GAAP figures for the quarter include a non refundable upfront fee to Osiris Therapeutics Inc. for a late-stage product candidate, amortization and stock compensation expenses, and a charge to write off overhead and material associated with incomplete process validation runs at the company’s Belgium manufacturing facility. “We had an excellent year last year and exceeded our earnings expectations despite the economic environment and the challenges we faced with Myozyme,” said Henri A. Termeer, Genzyme chairman and chief executive officer. “We delivered on our financial objectives but did not ignore our future. We continued to expand and invest in our pipeline and now have seven exciting late-stage programs with the potential to sustain our growth over the long term. Genzyme is stronger today than it was a year ago, and we feel confident about our future.” As previously announced, fourth-quarter revenue rose 13 percent to $1.17 billion, reflecting an approximate $39 million negative impact of foreign exchange, compared with $1.04 billion in the same period in 2007. Individual product sales for the fourth quarter and the year, along with expectations for the longer-term growth of Genzyme’s business segments, were detailed in a January 13, 2009, press release coinciding with the company’s presentation at the JPMorgan Healthcare Conference. 2008 Results Total revenue in 2008 increased 21 percent to $4.6 billion from $3.8 billion in 2007. GAAP net income was $421.1 million, or $1.50 per diluted share, compared with $480.2 million, or $1.74 per diluted share, in 2007. Non-GAAP net income increased 18 percent to $1.1 billion, compared with $939.9 million in 2007. Non-GAAP earnings increased 15 percent to $4.00 per diluted share from $3.47 in 2007. Genzyme generated approximately $1.5 billion in cash predominantly from operations in 2008 and utilized this cash flow to substantially eliminate all debt, invest in its global infrastructure, repurchase shares, and complete strategic transactions that significantly strengthened its late-stage pipeline. Financial Guidance for 2009 Earnings
Revenue
Total revenue for the Genetic Disease segment is expected to reach $2.47 – $2.53 billion this year, compared with $2.23 billion in 2008.
The Cardiometabolic and Renal segment’s total revenue is expected to increase to $1.04 – $1.07 billion this year, compared with $956 million in 2008.
Total revenue for the Biosurgery segment is expected to reach $540 – $570 million this year, compared with $491 million in 2008.
The Hematologic Oncology segment’s total revenue is expected to rise to $185 – $210 million this year, compared with $117 million in 2008.
Other revenue is expected to reach $1.02 – $1.08 billion in 2009, compared with $814 million in 2008.
Gross Margin
Expenses
Tax Rate
Capital Expenditures
Development Programs Genzyme’s R&D pipeline includes seven major late-stage programs with the potential to sustain the company’s growth beyond 2011: Clolar for adult AML Genzyme has filed for FDA approval of Clolar as a first-line therapy for adult acute myeloid leukemia. If this application receives priority review, Clolar could be approved for this indication in the first half of 2009. An E.U. filing is anticipated in the second half of 2009, with approval expected in the first half of 2010. Clolar is currently approved in the United States and Europe for the treatment of acute lymphoblastic leukemia in relapsed and refractory pediatric patients. Alemtuzumab for multiple sclerosis Genzyme continues to enroll patients in two phase 3 trials of alemtuzumab, which has the potential to become a new standard of care in the treatment of multiple sclerosis. Enrollment in the study involving previously untreated patients is expected to conclude by mid year, and enrollment in the study involving treatment-experienced patients is expected to conclude in the first half of next year. The design of the latter study has been modified to eliminate its high-dose arm based on final phase 2 data showing that both the high and low doses of alemtuzumab were efficacious when compared to interferon beta-1a. Results for the treatment naïve study are expected in 2011, and Genzyme anticipates approval of alemtuzumab in 2012. Mipomersen for high-risk hypercholesterolemia Genzyme and Isis Pharmaceuticals Inc. formed a collaboration in 2008 to develop and commercialize the novel lipid-lowering drug mipomersen for patients with high cholesterol who are at high risk of cardiovascular disease. The companies have begun three late-stage studies of mipomersen during the past year, and a fourth is currently screening patients. The companies have also completed enrollment in a phase 3 trial involving patients with homozygous familial hypercholesterolemia. Top-line data are expected in mid-2009. The submission of a U.S. marketing application for this indication is anticipated during the second half of 2010, and the first approval is expected in 2011. An outcome study is expected to begin by mid-2010. Prochymal™ for graft vs. host disease and Crohn’s disease Genzyme and Osiris Therapeutics Inc. formed a collaboration last year to develop and commercialize the adult stem cell treatment Prochymal. Data from phase 3 studies of Prochymal in graft vs. host disease (GvHD) and Crohn’s disease are expected in 2009, and Osiris also expects to seek FDA approval for the GvHD indication this year. GENZ-112638 for Gaucher disease Genzyme is preparing to initiate two phase 3 studies of Genz-112638, a potential oral therapy for Gaucher disease, following the positive outcome of a recent meeting with the FDA to discuss study design. Patient enrollment is expected to begin during the first half of the year. Final results from the open-label phase 2 study will be presented February 20 at the Lysosomal Disease Network’s WORLD Symposium. Ataluren for Duchenne muscular dystrophy Genzyme and PTC Therapeutics Inc. formed a collaboration in 2008 to develop and commercialize ataluren (formerly known as PTC124), a novel oral therapy for the treatment of genetic disorders due to nonsense mutations, which is potentially applicable to hundreds of diseases. A pivotal phase 2b trial of ataluren in Duchenne muscular dystrophy (DMD) is fully enrolled and results are expected next year. A trial in cystic fibrosis (CF) is expected to begin during the first half of this year. Other Key Programs Genzyme expects to begin a pivotal trial of an advanced phosphate binder (APB) this year. The APB is designed to more effectively bind phosphate for a substantial improvement in potency over existing therapies while maintaining all the benefits of sevelamer. The company anticipates that the APB will be approved by the time the core patent estate for sevelamer expires in 2014. During the first half of 2010, Genzyme expects to file an IND for a potential second-generation enzyme replacement therapy for Pompe disease that in preclinical studies to date has demonstrated a five-fold greater substrate clearance vs. alglucosidase alfa.
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 more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. 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. This press release contains forward-looking statements regarding Genzyme financial outlook and business plans and strategies, including without limitation: its anticipated compound average earnings growth rate from 2006-2011; its Q1 2009, YE 2009 and YE 2011 EPS guidance and drivers of EPS growth; its projected 2009 revenues for the company, for each business segment, for certain products, including Myozyme, Fabrazyme, Cerezyme, Renagel/Renvela, and Mozobil, and all other revenues, as well as the anticipated drivers of such revenue growth; the expected timing of receipt of regulatory approvals for alglucosidase alfa produced at the 2000L scale in the US and 4000L scale in the EU; its regulatory approval plans and timetables for existing products, including EU approval of Renvela, US approval of Renvela for use in CKD patients not on dialysis, EU approval of Mozobil, US approval of Synvisc-One, US and EU approval of Clolar for use in adult patients with AML, and US approval of alemtuzumab-MS; its plans and estimated timetables for new and next-generation product filings and approvals, including for mipomersen, Genz-112638, Prochymal, Ataluren, and APB; its projected 2009 non-GAAP gross margin, SG&A and R&D expenses as a percentage of revenues; its expected 2009 GAAP and non-GAAP tax rates; and its projected 2009 capital expenditures. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: the ability of Genzyme and its collaboration partners to successfully complete preclinical and clinical development of new products, including mipomersen, Prochymal, Genz-112638, and Ataluren; Genzyme's ability to expand the use of current and next-generation products in existing and new indications, including Renvela, Synvisc-ONE, Mozobil, Clolar, alemtuzumab-MS and the APB; Genzyme's ability to obtain and maintain regulatory approvals for products and manufacturing facilities, including alglucosidase alfa produced at the 2000L and 4000L scales and the timing of receipt of such approvals; Genzyme's ability to manufacture products and product candidates in a timely and cost effective manner and in sufficient quantities to meet demand; Genzyme’s ability to maintain and enforce intellectual property rights; Genzyme's ability to successfully identify and market to new patients; the scope of third-party reimbursement coverage for Genzyme's products and services; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2008. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today’s date and Genzyme undertakes no obligation to update or revise the statements. Genzyme®, Myozyme®, Fabrazyme®, Cerezyme®, Renagel®, Renvela®, Synvisc®, and Clolar® are registered trademarks and Mozobil™, Synvisc-One™ and Lumizyme™ are trademarks of Genzyme Corporation or its subsidiaries. Prochymal™ is a trademark of Osiris Therapeutics Inc. All rights reserved. Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States. Conference Call Information Genzyme will host a conference call today at 11:00 a.m. Eastern. To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.” A replay of this call will be available by dialing 402-998-1342. This call will also be Webcast live on the investor events section of www.genzyme.com. Replays of the call and the Webcast will be available until midnight on February 18, 2009. Upcoming Events Genzyme will host a conference call on April 22 at 11:00 a.m. Eastern to discuss financial results for the first quarter of 2009. To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.” A replay of this call will be available by dialing 402-998-1342. This call will also be Webcast live on the investor events section of www.genzyme.com. Replays of the call and the Webcast will be available until midnight on April 29, 2009. |
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