CAMBRIDGE, Mass., July 23 /PRNewswire-FirstCall/ -- Genzyme Corporation today reported strong sales and profit growth in the second quarter, along with significant progress in its commercial and clinical programs.
Revenue increased 25 percent to approximately $1.171 billion from $933.4 million in last year’s second quarter. The increase was driven by growth across all areas of the business.
GAAP net income was $69.6 million, or $0.25 per diluted share, compared with $83.8 million, or $0.31 per diluted share, in the second quarter a year ago. GAAP net income reflects the fee for the license to mipomersen, a highly promising cholesterol-lowering drug in late-stage development.
Non-GAAP net income increased to $268.5 million from $238.7 million in last year’s second quarter. Non-GAAP earnings increased to $0.98 per diluted share from $0.88.
Genzyme continues to reinvest cash from operations to build a foundation for long-term growth. In the second quarter, the company generated approximately $329 million in cash from net income prior to one-time events and proceeds from the issuance of common stock. The company made a $175 million payment to Isis Pharmaceuticals to secure the rights to mipomersen, significantly strengthening its late-stage pipeline. Genzyme also invested approximately $130 million in capital projects, predominantly focused on expanding manufacturing capacity to meet current and anticipated product demand. To reduce the dilutive effect of equity compensation, the company used a portion of its cash to repurchase 1 million shares under its three-year stock buyback program.
“It was a strong and highly productive quarter,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We delivered solid financial results, set in place a number of catalysts that will drive near-term growth, and continued to build the company to grow beyond 2011.”
Over the next 12 months, Genzyme anticipates six potential approvals for new products or broader indications for existing products. These catalysts will provide significant near term momentum:
-- Genzyme expects FDA approval by the end of this year for alglucosidase alfa (Myozyme(R)) produced at the 2000L bioreactor scale, following the submission of a BLA on May 30. European approval of Myozyme produced at the 4000L scale is expected in the first half of next year.
-- The company anticipates that the labeling for Renvela(R) (sevelamer carbonate) will be expanded by mid-2009 to include the treatment of chronic kidney disease patients with elevated phosphorus levels who are not on dialysis. Genzyme, along with two other companies, submitted a position paper to the FDA in May regarding this expanded use of phosphate binders.
-- Genzyme also expects that the labeling for Clolar(R) (clofarabine) will be expanded by the middle of next year to include its use in treating adult patients with acute myelogenous leukemia. The company plans to file supplemental marketing applications this year to broaden Clolar’s indication.
-- Genzyme expects to launch Mozobil(TM) (plerixafor) in the United States and Europe during the first half of next year, following regulatory approval. The company submitted marketing applications for the product last month. Mozobil is intended to enable patients with certain types of cancers to successfully receive a stem-cell transplantation.
-- FDA action on Genzyme’s marketing application for Synvisc-ONE(R) (hylan G-F 20) is anticipated this year. The company submitted a response to the agency in June that included additional analysis and data requested in a November 2007 letter.
Genzyme continues to expect non-GAAP earnings for this year of approximately $3.90 per diluted share. GAAP earnings in 2008 are expected to be approximately $2.20 per diluted share. The GAAP estimate now reflects Genzyme’s equity investment in Isis Pharmaceuticals, the mipomersen licensing fee, along with anticipated amortization, stock-compensation expenses and the effect of contingent convertible debt.
Second-Quarter Product Sales
Within the Therapeutics business, Myozyme revenue rose 65 percent compared with last year’s second quarter, despite the constraint on U.S. sales resulting from the delay in approval of 2000L-scale production. Revenue increased to $77.2 million from $46.7 million in the same period a year ago. The FDA is expected to convene an advisory committee meeting in October to discuss the BLA for alglucosidase alfa produced at the 2000L-scale, as required for all new drug and biologics license applications under the FDA Amendments Act enacted last year. FDA approval of 2000L-scale production is needed to provide broader access to product for adult patients in the United States.
The launch of Myozyme has been more rapid than the launch of any of Genzyme’s other treatments for lysosomal storage disorders, driven by faster than expected adoption by physicians and patients and consistent support from health authorities in more than 40 countries. To meet the global demand for Myozyme, Genzyme is working to secure approval of production at its 4000L bioreactor scale manufacturing plant in Belgium, which would significantly expand capacity. The company is conducting process validation runs for Myozyme produced at the 4000L-scale, which it expects to complete this year and subsequently file for EMEA approval. The company expects that European authorities will approve Myozyme production at the facility during the first half of 2009. Approval of 4000L-scale production in Belgium will be necessary to meet the anticipated global demand for Myozyme. Product supply in 2009 is expected to be particularly tight until the Belgium plant is approved.
Genzyme’s other treatments for lysosomal storage disorders also continue to experience strong, double-digit growth. Second-quarter Cerezyme(R) (imiglucerase for injection) sales rose 13 percent to $319.4 million, compared with $283.0 million in the previous second quarter. Sales of Fabrazyme(R) (agalsidase beta) grew 21 percent, rising to $126.6 million from $104.3 million. Sales of Aldurazyme(R) (laronidase) increased 33 percent to $38.8 million, compared with $29.1 million in the second quarter last year when the product’s sales were recorded under the joint venture with BioMarin Pharmaceutical Inc.
The company also reported preliminary results from a Phase 2 trial of its investigational oral therapy for Gaucher disease Genz-112638. The results were consistent with those observed for patients beginning enzyme replacement therapy, and they highlight the potential of this compound to provide a convenient treatment alternative for patients and a broader range of treatment options for physicians. Genzyme is developing protocols for two Phase 3 trials that it expects to initiate early next year.
Sales of Thyrogen(R) (thyrotropin alfa for injection) remained strong, increasing 34 percent to $39.4 million from $29.5 million. The use of Thyrogen in ablation procedures is contributing to the product’s growth in the United States, while its growth in Europe is being driven by increasing diagnosis of thyroid cancer and its international adoption is being driven by expansion into new geographic markets.
Within the Renal business, sales of sevelamer therapies Renagel(R) (sevelamer hydrochloride) and Renvela grew 16 percent to $168.6 million from $144.9 million in the second quarter last year. Genzyme launched Renvela in the United States in March, and the product is now included in more than 85 percent of health plan formularies. Formulary access equal to that of Renagel is expected by the end of the third quarter, ahead of Genzyme’s expectations.
Within the Transplant business, second-quarter sales of Thymoglobulin(R) (Anti-thymocyte Globulin [Rabbit]) and Lymphoglobuline(R) (Anti-thymocyte Globulin [Equine]) rose 10 percent to $45.6 million from $41.4 million in the second quarter last year. Worldwide demand for Thymoglobulin continues to grow, and Genzyme is working to build inventory to meet anticipated demand following resolution of a manufacturing issue during 2007 that affected product appearance in some lots. The company has begun construction of a new manufacturing plant for Thymoglobulin in France to support the long-term growth of the product.
Genzyme continues to prepare for the U.S. and European launch of Mozobil next year, and it is also planning to seek regulatory approvals globally. The company anticipates peak annual sales of Mozobil in the transplant setting of $400 million. More than 900 patients have already received the product through a compassionate use program in the United States, and similar compassionate use programs have recently begun in Europe. Genzyme continues to invest in studies exploring additional potential applications for Mozobil, including its use in conjunction with chemotherapy.
Within the Biosurgery business, sales of Synvisc(R) (hylan G-F 20) and Synvisc-ONE rose to $70.9 million from $64.9 million, an increase of 9 percent. The growth was driven by the increasing strength of Synvisc in the U.S. market and the initiation of direct sales of the product in Latin America. Genzyme is introducing Synvisc-ONE in a growing number of European and Southeast Asian countries. The product is designed to simplify osteoarthritis pain management and thereby reach a broader set of patients.
Also within the Biosurgery business, sales of Sepra(R) products have remained consistently strong over recent quarters. Sales rose 39 percent in this year’s second quarter to $34.8 million from $25.1 million in the same quarter a year ago. This growth is being driven by the expanded U.S. sales force for Seprafilm(R) adhesion barrier, which is helping to expand the product’s use in gynecologic and colorectal surgery and C-section procedures.
Second-quarter revenue for the Genetics business increased 7 percent to $78.5 million from $73.7 million. This growth was driven in part by the continuing demand for prenatal screening for genetic conditions. Additionally, Genzyme experienced increased demand for its KRAS mutation testing for colorectal cancer, as recent studies have shown that identifying KRAS mutations can assist oncologists in selecting treatment for patients with colorectal cancer. This increasing recognition of the value of diagnostics in personalized medicine will continue to fuel organic growth in the Genetics business.
Oncology revenue rose in the second quarter to $33.3 million from $17.4 million based on increasing sales of Clolar and Campath(R) (alemtuzumab). The increase also reflects the addition of European sales of Clolar, which Genzyme began recording following its acquisition of Bioenvision Inc. late last year. Genzyme is working to introduce Clolar worldwide as well as expand its indications. The product is currently approved in the United States and Europe as a third-line treatment for pediatric patients with acute lymphoblastic leukemia. Genzyme is developing Clolar for use globally as a first-line therapy for adult AML and myelodysplastic syndromes, significantly larger indications that the company estimates will drive peak annual sales of the product to approximately $600 million. Last month, Genzyme reported encouraging results from its pivotal CLASSIC II trial evaluating the use of Clolar to treat older adult patients with acute myeloid leukemia. Oncology revenue also reflects growing first-line use of Campath in the treatment of patients with B-cell chronic lymphocytic leukemia.
Genzyme took a number of major steps during the second quarter to create opportunities for growth beyond 2011 by significantly strengthening its pipeline and expanding its global infrastructure:
-- The company secured exclusive worldwide rights to mipomersen, an innovative cholesterol-lowering drug in Phase 3 development that has the potential to change the standard of care for severely ill patients whose needs cannot be addressed by current therapies.
-- Genzyme also formed a collaboration this month with PTC Therapeutics to develop and commercialize PTC124, a novel oral therapy under development initially for Duchenne muscular dystrophy and cystic fibrosis. The product has broad potential in a range of other inherited disorders.
-- Genzyme continued to enroll patients in two ongoing Phase 3 trials of alemtuzumab for the treatment of multiple sclerosis. Final, three-year efficacy and safety data from the Phase 2 trial comparing alemtuzumab with Rebif(R) (interferon beta-1a) for the treatment of relapsing-remitting multiple sclerosis were presented during the quarter as part of a scientific platform session at the American Academy of Neurology. The company is awaiting publication of these results.
-- Genzyme announced plans for a research and development center in China and also began building a commercial organization in India, initiatives that reflect the company’s commitment to establishing a long-term presence in both countries.
This press release contains forward-looking statements regarding Genzyme’s financial outlook and business plans and strategies, including without limitation: its 2008 earnings guidance; its expectations for approval of Myozyme produced at the 2000L and 4000L-scale capacities, the timing thereof and its assessment of product supply; its plans to seek regulatory approvals of existing products for use in new indications, including Renvela for CKD and Clolar for adult AML, the timetables therefore and the impact of such approvals on the company; its plans and estimated timetables for new and next- generation product filings, approvals and launches, including for Mozobil, Genz-112638, and Synvisc-ONE, its estimates of the sales potential of Clolar and Mozobil; its anticipated growth drivers for certain products and businesses, including Genetics; and its expectations for Renvela formulary access. 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: Genzyme’s ability to obtain and maintain regulatory approvals for products and manufacturing facilities, including Myozyme produced at the 2000L scale in the US and at the 4000L scale in Europe and the timing of receipt of such approvals; Genzyme’s ability to successfully complete preclinical and clinical development of its products and product candidates, including Mozobil and Genz-112638; Genzyme’s ability to expand the use of current and next-generation products in existing and new indications, including Renvela, Clolar and Synvisc-ONE; Genzyme’s ability to manufacture its products, including Thymoglobulin and its LSD therapies in a timely and cost effective manner and in sufficient quantities to meet demand; 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 2008 Quarterly Report on Form 10-Q for the quarter ended March 31, 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(R), Myozyme(R), Fabrazyme(R), Cerezyme(R), Thyrogen(R), Renagel(R), Renvela(R), Thymoglobulin(R), Synvisc(R), Campath(R) and Clolar(R) are registered trademarks of and Mozobil(TM) and Synvisc-ONE(TM) are unregistered trademarks of Genzyme or its subsidiaries. Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC. All rights reserved.
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 more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 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 nearly 90 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 diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, cardiovascular disease, and other areas of unmet medical need.
Conference Call Information
Genzyme will host a conference call today at 11:00 a.m. Eastern to discuss results for the second quarter of 2008. To participate in the call, please dial 1-773-799-3828 and refer to passcode “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 July 30, 2008.
Upcoming Events
Genzyme will host a conference call on October 22, 2008 at 11: 00 a.m. Eastern to discuss financial results for the third quarter of 2008. 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 October 29, 2008.
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.
CONTACT: Media, Bo Piela, +1-617-768-6579, or Investors, Patrick Flanigan,
+1-617-768-6563
Web site: http://www.genzyme.com/
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