Genzyme Corp. (NASDAQ: GENZ) today reported that second-quarter revenue was $1.08 billion, compared with $1.23 billion in the same period last year, reflecting limited shipments of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) due to product supply constraints in 2010. The company expects to be able to increase shipments of Cerezyme and Fabrazyme during the second half of the year.
“Genzyme Corporation Reconciliation of GAAP to Non-GAAP Earnings”
GAAP net income was $23,000, or $0.00 per diluted share, compared with net income of $187.6 million, or $0.68 per diluted share, in the second quarter of 2009. Non-GAAP net income was $47.6 million, or $0.18 per diluted share, compared with $226.6 million, or $0.82 per diluted share, in the same period last year.
GAAP and non-GAAP figures include pre-tax manufacturing write-offs of $21.9 million, or $0.06 per diluted share, primarily for material that had to be discarded following the interruption in operations at the Allston facility late in the first quarter and for costs associated with the temporary shutdown of the company's Haverhill, U.K., facility in December 2009. These figures also include a pre-tax write-down of $32.3 million, or $0.08 per diluted share, for the company's 2008 equity investment in Isis Pharmaceuticals, reflecting the extent to which the share price paid exceeds the current market value. Non-GAAP net income excludes stock compensation expenses and costs associated with the acquisition of oncology products from Bayer.
"This was a difficult quarter as reflected in our financial results, but based on the progress we've made with our recovery efforts, the outlook for the second half of 2010 is promising," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "We are encouraged by the improvements in Cerezyme and Fabrazyme manufacturing. We expect that increasing sales of these products combined with reductions in our operating costs will produce an increase in earnings during the second half of the year."
During the second quarter, Genzyme continued to make progress in transforming its manufacturing operations, maximizing the potential of its product portfolio, and advancing key pipeline programs to ensure sustainable long-term growth. Major operational milestones included FDA approval of Lumizyme™ (alglucosidase alfa) for late-onset Pompe disease patients in the United States; progress in moving fill/finish operations out of the Allston manufacturing facility; and the strongest quarter to date in the ongoing U.S. launch of Synvisc-One.
The company also continues to make progress in executing its plan for shareholder value creation announced in May. The plan builds on the series of operational and organizational changes the company has made over the past year.
- Last month, Genzyme completed a debt offering of $1 billion. This debt was used to enter into an accelerated stock buyback for the first half of a $2 billion share repurchase. The full impact of this buyback on the company's weighted average share count will be seen in the third and fourth quarters.
- The company has made progress in its efforts to find strategic alternatives for its Genetics, Diagnostics, and Pharmaceuticals businesses, and is on-track to complete transactions by the end of this year.
- Genzyme has retained independent consultants and has begun identifying potential efficiencies and cost reductions to improve its operating margins. The company is in the process of evaluating its global organization and cost structure to develop a multi-year action plan which will be implemented beginning this fall.
In the area of corporate governance, Genzyme settled its proxy contest and shareholders re-elected all of the company's directors. In addition, Genzyme's board appointed Steven Burakoff, M.D., Eric Ende, M.D., and Dennis Fenton, Ph.D., as directors.
Product Supply Update
Production of Cerezyme is now in-line with historical averages and the Allston facility remains fully operational. With production proceeding successfully, Genzyme will begin increasing shipments in August. The company expects that patients will be able to begin increasing their doses in September and return to normal dosing in the fourth quarter. Genzyme will increasingly look to make therapy available to new patients in need during the fourth quarter as supply becomes available.
Genzyme continues its efforts to improve the productivity of the Fabrazyme manufacturing process, and has received both FDA and EMA approval to use the new working cell bank. As previously communicated, the current shipping allocations will remain in place for the third quarter. Shipments of Fabrazyme are expected to increase in the fourth quarter.
Since levels of demand, ordering patterns and dose regimens vary by region, Genzyme staff in countries around the world will provide patients and physicians with more information on the local impact of this guidance for each product. Because inventories remain limited, any manufacturing disruptions or delays in shipping can impact availability of Cerezyme and Fabrazyme.
At the company's new Framingham manufacturing facility, two bioreactors are currently operational and Fabrazyme engineering runs are planned for September. The facility is on-track for approval, anticipated in late 2011.
During the second quarter, Genzyme began implementing changes to address requirements of the FDA consent decree, including transitioning fill/finish operations out of its Allston facility. The company signed a new agreement with Hospira Worldwide Inc., which will provide fill/finish manufacturing services for some of the company's products. Genzyme has transitioned fill/finish for Cerezyme and Myozyme to its Waterford, Ireland facility, and is in the process of transferring Thyrogen® (thyrotropin alfa for injection) and Fabrazyme fill/finish to Hospira. Process validation runs for Thyrogen and Fabrazyme are underway at Hospira, and the company is on-track to meet its late November 2010 deadlines to complete this transition for all Thyrogen and Fabrazyme that is sold in the United States.
2010 Financial Guidance
Genzyme is providing new 2010 financial guidance based on several factors, including: updated information regarding Cerezyme and Fabrazyme supply; the consent decree; and the estimated impact of foreign exchange, health care reform in the United States, and new product pricing being implemented in the European Union. Please see the attached guidance sheet for additional detail and a reconciliation to the company's previous guidance.
Cerezyme revenue is expected to be $725 million - $775 million and Fabrazyme revenue is expected to be $200 million - $220 million. Total 2010 revenue is expected to be $4.4 billion - $4.5 billion. Non-GAAP EPS is expected to be $0.40 - $0.50 per diluted share in the third quarter, $0.90 - $1.00 per diluted share in the fourth quarter, and $1.90 - $2.00 per diluted share for the full year. This new guidance excludes revenue and expenses in the second half of the year for the three businesses that are expected to be divested.
Second Quarter Results and Business Updates
Within the Personalized Genetic Health segment, second-quarter sales of Myozyme® (alglucosidase alfa) increased 16 percent to $92.1 million from $79.3 million in the same period in 2009. Second-quarter revenue reflects a negative $3.7 million impact of foreign exchange. Genzyme on May 24 received FDA approval for Lumizyme, and has implemented a Risk Evaluation and Mitigation Strategy (called the Lumizyme ACE Program) to ensure that the appropriate patients receive Lumizyme commercially.
Genzyme has initiated this program with the health care professionals involved in the Alglucosidase Alfa Temporary Access Program (ATAP), the program created in 2007 through which Genzyme has provided therapy free of charge to nearly 200 patients prior to commercial approval of Lumizyme. Genzyme will keep ATAP open until August 20, 2010 to ensure that patients have uninterrupted therapy while working to enroll participants in the Lumizyme ACE Program. Genzyme has also begun working with U.S. health care professionals to enable those adult patients who have been waiting to access treatment to begin Lumizyme therapy.
Second-quarter sales of Cerezyme were $138.7 million compared with $298.1 million in the second quarter of last year and sales of Fabrazyme were $39.5 million, compared with $134.3 million in the same period last year. Due to supply constraints, Cerezyme was shipped at 50 percent of demand and Fabrazyme was shipped at 30 percent of demand for the entire second quarter.
Within the Biosurgery segment, sales of Synvisc® (hylan G-F 20) increased 31 percent to $107.7 million from $82.4 million in last year's second quarter, driven by Synvisc-One, which was launched in the United States in March 2009. Growth is resulting both from gains in market share and from overall expansion of the U.S. viscosupplement market, which grew approximately 14 percent in the first half of 2010 compared with the same period last year. Synivsc-One now represents two-thirds of all U.S. Synvisc revenue.
Within the Renal and Endocrinology segment, sales of Genzyme's sevelamer therapies, Renvela® (sevelamer carbonate) and Renagel® (sevelamer hydrochloride), were $170.1 million, compared with $175.4 million during the second quarter of 2009, reflecting increased U.S. sales volume offset by price decreases being implemented by some E.U. countries. The ongoing launch of Renvela in Europe continues to progress well, with launches in the key markets of France, Spain, Italy and the U.K. expected to take place during the second half of 2010.
Sales of Thyrogen increased 8 percent to $46.3 million from $42.9 million in the second quarter of 2009. In accordance with terms of the consent decree, a Dear Healthcare Provider letter describing the patients for whom FDA considers Thyrogen to be medically necessary is currently being included in all U.S. shipments of Thyrogen. Genzyme has limited its promotional activities in the United States to be consistent with the requirements of the consent decree. Once fill/finish operations are transferred to Hospira, the criteria will no longer be in effect and Genzyme will resume normal U.S. promotional work.
Total revenue for the Hematology and Oncology segment, including the oncology products acquired from Bayer in May 2009, increased 58 percent to $176.5 million from $112.0 million in last year's second quarter.
Within this segment, sales of Mozobil® (plerixafor injection) nearly doubled to $22.1 million from $11.7 million in the second quarter last year, reflecting a 23 percent increase in U.S. sales and the robust launch in Europe. Sales of Thymoglobulin® (anti-thymocyte globulin, rabbit) increased 9 percent to $58.2 million compared with $53.6 million in the second quarter of 2009, with significant growth coming from the Asia-Pacific region.
Second-quarter growth in this segment was also driven by sales of Clolar® (clofarabine injection), which increased 29 percent to $25.5 million from $19.7 million in the same period a year ago, with volume growth occurring in all major markets. Data from the phase 3 trial of Clolar in combination with an approved therapy in second-line adult acute myeloid leukemia are expected in the fourth quarter, and positive findings would support regulatory filings for a label expansion in this indication.
Other revenue - which includes the company's Genetics, Diagnostics, and Pharmaceuticals businesses - was $130.0 million in the second quarter of 2010 compared with $143.1 million in the same period last year.
Genzyme's GAAP SG&A was $402.5 million, compared with $354.1 million in the second quarter of 2009. Non-GAAP SG&A was $375.9 million compared with $316.3 million in the same period last year. SG&A reflects expenses associated with the acquisition of the Bayer oncology products, the proxy contest, and consent decree legal fees.
The company's GAAP R&D was $225.6 million compared with $210.5 million in last year's second quarter; non-GAAP R&D was $211.5 million compared with $190.7 million in the second quarter of 2009.
Late-Stage R&D Programs
Genzyme has a strong late-stage pipeline that is expected to help drive long-term growth:
- Five-year follow-up data from Genzyme's phase 2 trial of alemtuzumab in multiple sclerosis have been accepted for presentation at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting in October. Two phase 3 studies are ongoing and data are expected next year. Genzyme has finalized its regulatory filing strategy, and now plans to await results of both phase 3 studies and file with data from the two trials to provide the most robust submission. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this submission.
- Enrollment is underway in three global, multi-center, phase 3 trials of eliglustat tartrate, Genzyme's investigational oral therapy for patients with Gaucher disease type 1. There are currently a total of 48 active sites for these trials, with additional sites preparing to begin enrollment. This therapy has the potential to transform the treatment experience for patients by providing a daily oral capsule option instead of bi-weekly infusions.
- Genzyme and Isis Pharmaceuticals Inc. expect to report data this quarter from two phase 3 studies of mipomersen: one includes patients with severe hypercholesterolemia and the other includes hypercholesterolemic patients at high risk for coronary heart disease. These two studies are the last of the four phase 3 trials that will contribute to the initial U.S. and E.U. regulatory filings for the product, which will seek approval for the treatment of patients with the genetic disease homozygous familial hypercholesterolemia. These two filings may also include patients with severe hypercholesterolemia, and are anticipated in the first half of 2011.