Genzyme (NASDAQ:GENZ)

“Results for the second quarter showed the strength of our diversified business, with many newer products, such as Synvisc-One, contributing to our growth,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are working through the Allston manufacturing interruption in a constructive way. At the same time, we are continuing to build the company for the future, making progress in our late-stage pipeline and bringing new products to patients.”

Genzyme last month announced that it had detected a virus that impairs cell growth in a bioreactor used for Cerezyme production at its Allston facility. The company decided to temporarily interrupt production at the plant – which was manufacturing Cerezyme, Fabrazyme and Myozyme – to sanitize the facility.  Genzyme has now completed the sanitization and is on-track to resume production at Allston this month.

Genzyme is adjusting its previously announced 2009 financial guidance based on the estimated impact of the temporary Allston shutdown and revised assumptions about the timing of the expected availability of Lumizyme in the United States.

^a The above forecasts reflect the Company's current and preliminary views and are therefore subject to change. Please refer to the Company's Safe Harbor Statement (usually in press releases) for the factors that could cause actual results to differ materially from those contained in any forward-looking statement.

^b Non-GAAP EPS figures generally exclude certain non-operating gains and losses as well as certain non-cash items. Non-GAAP information should not be viewed in isolation or as a substitute for reported, or GAAP information . For a more complete explanation of the company's definition of non- GAAP please refer to its financial press releases. The GeoTeam® non-GAAP figures may, from time to time, differ from company supplied figures.

“We came through the first quarter well despite the weak economy and unfavorable exchange rates, and we are on track to meet our financial objectives this year,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “Our broad geographic and product diversification, as well as the clinical value of our products, position us to manage through this period and continue to grow. We will see further progress and results over the coming months from our R&D investment in late-stage programs.”

Based on the expected growth rates of the company’s businesses and the anticipated impact of several key growth drivers, Genzyme reaffirmed its revenue and earnings guidance for 2009.

Source: Business Wire (April 22, 2009)

Guidance Report:

Genzyme is on-track to achieve its goal of 20 percent compound average non-GAAP earnings growth from 2006 – 2011. Non-GAAP earnings are projected to rise to approximately $7.00 per diluted share by 2011.

Non-GAAP earnings in the first quarter of 2009 are expected to be similar to earnings for the fourth quarter of 2008. Genzyme anticipates that its non-GAAP earnings will accelerate starting in the second quarter, as two key regulatory approvals for Myozyme® (alglucosidase alfa) are secured: E.U. approval of Myozyme produced at the 4000 L scale, which will help provide the capacity to meet the strong global demand for the product; and U.S. approval of Myozyme produced at the 2000 L scale, which will be called Lumizyme™ (alglucosidase alfa), giving the company the ability to promote the Pompe disease therapy produced at this scale in the U.S. market. Mozobil™ (plerixafor injection), which was launched last month, will also help drive earnings growth.

Full Year Fiscal 2009 Guidance Ending December

Genzyme is on-track to achieve its goal of 20 percent compound average non-GAAP earnings growth from 2006 – 2011. Non-GAAP earnings are projected to rise to approximately $7.00 per diluted share by 2011

Non-GAAP earnings in the first quarter of 2009 are expected to be similar to earnings for the fourth quarter of 2008. Genzyme anticipates that its non-GAAP earnings will accelerate starting in the second quarter, as two key regulatory approvals for Myozyme® (alglucosidase alfa) are secured: E.U. approval of Myozyme produced at the 4000 L scale, which will help provide the capacity to meet the strong global demand for the product; and U.S. approval of Myozyme produced at the 2000 L scale, which will be called Lumizyme™ (alglucosidase alfa), giving the company the ability to promote the Pompe disease therapy produced at this scale in the U.S. market. Mozobil™ (plerixafor injection), which was launched last month, will also help drive earnings growth.

*Non-GAAP EPS Figures exclude non-operating gains and losses. 

Source: Business Wire (February 11, 2009)