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StemCells submits milestone CNS filing in Batten disease

StemCells has filed its first investigational new drug application to the FDA, subject to approval of which the company plans to begin its first clinical investigation of its human brain stem cells in Batten disease.

Looking forward for the full year 2009, the company anticipates that its reported revenues will be between a 1% decline and 1% growth over 2008. Excluding a 4% unfavorable impact from changes in foreign currency, the company anticipates revenues will grow between 3 and 5%, which includes the impact from the company’s acquisition of Guava Technologies. Millipore is raising its outlook for non-GAAP earnings per share and expects non-GAAP EPS to be in a range between $3.75 and $3.90 per share in 2009, compared to its earlier outlook of $3.70 to $3.85 per share. The company is also raising its guidance for free cash flow, which it expects will total about $220 million for the full year, compared to its earlier outlook of $210 million.

“Our strong financial performance in the face of a difficult economic environment reflects the resiliency of our business model, the relative health of our customers, and our ability to deliver innovative solutions,” said Martin Madaus, chairman & chief executive offficer of Millipore. “More than ninety% of our revenues are derived from consumable products and services, which are being less affected by pullbacks in customer spending. Our business is well diversified across end-markets, product lines, and geographies. This diversity provides us important balance and flexibility in managing our business, especially during these challenging times.

“The exceptional revenue growth we generated in our Bioprocess Division this quarter was driven by a resurgence in spending from our large, North American biotechnology customers. Additionally, the division saw strength across a broad spectrum of customers and markets as it generated double-digit revenue growth in all three of its product categories and in both North America and Europe. Our Bioscience Division continued to deliver solid performance, as double-digit growth in Europe and strong demand for our consumable products used in cellular biology and protein research drove the division’s results.”

Madaus added, “While we are off to a strong start, we know that we are not immune to the downside risks created by the global economic recession. We expect to see a slowdown in spending from our pharmaceutical customers and weakness in certain Asian countries as we progress through the year. However, when we weigh these risks against our performance in the first quarter, we continue to believe that we will generate attractive operational results in 2009. As a result, we are raising our annual guidance for free cash flow and non-GAAP earnings per share.”

“Our strong revenue growth in the first quarter drove significant operating leverage, enabling us to generate a 33% increase in our non-GAAP earnings per share and a 154% increase in our free cash flow,” said Charles Wagner, Chief Financial Officer of Millipore. “A key driver of this operating leverage was the initiatives we put in place last year to align our cost structure and improve our efficiency. In addition to the strong fundamentals of our markets, our first quarter revenue growth also benefited from having four extra selling days compared to the first quarter of 2008 due to the timing of our quarter-end. The positive impact of these extra days will be offset in the fourth quarter when we will have five fewer selling days than we had in the previous year. Overall, despite these quarterly fluctuations, we believe 2009 will be a strong year of financial performance in a challenging environment.”