Staff Writer

Celgene Corp., the poster child of what a big biotech growth story should be, delivered yet another happy ending in the second quarter.

The Summit, N.J.-based firm reported total revenue of $1.18 billion, a 38 percent increase over the second quarter of 2010 and ahead of the $1.12 billion analysts had expected.

As always, most of those revenues came from sales of multiple myeloma drug Revlimid (lenalidomide), which garnered $795 million in the second quarter, beating analyst estimates of $773 million and representing 35 percent growth over the same period in 2010. Oppenheimer and Co. Inc. analyst Bret Holley wrote in a research note that the strong Revlimid sales "imply minimal/no headwinds" due to concerns about secondary malignancies, which had troubled the stock late last year. (See BioWorld Today, Dec. 7, 2010.)

Also beating analyst expectations were myelodysplastic syndrome drug Vidaza (azacitidine), breast cancer drug Abraxane (nab-paclitaxel) and multiple myeloma drug Thalomid (thalidomide).

Vidaza, with second-quarter sales of $162 million vs. street estimates of $148 million, posted a 23 percent gain over the same period in 2010. The drug's orphan drug exclusivity period expired this month, which means generic competition may soon be on the way, but Holley said "every month that goes by without a [generic] launch is unexpected upside for Celgene."

Abraxane sales were $95 million, well above the $79 million the street had expected. Celgene still has a long way to go to achieve its goal of pushing the drug to blockbuster status by 2015, but it's only been a year since the big biotech picked up Abraxane in its $2.9 billion acquisition of Abraxis BioScience Inc. (See BioWorld Today, July 1, 2010.)

Thalomid sales were $88 million, a decrease of 10 percent from 2010, but still above analyst estimates of $83 million.

Piper Jaffray analyst Ian Somaiya noted that while investors have sometimes complained that Celgene's strong top-line performance has not translated into bottom-line upside, the company reported second quarter non-GAAP net income of $417 million, or 89 cents per share, a 29 percent improvement over last year and above the 85 cents analysts had expected. Yet Celgene also managed to increase its non-GAAP research and development expenditures to $306 million, up from $202 million in the second quarter of 2010.

Celgene reported cash, equivalents and marketable securities of $2.79 billion at June 30.

All the good news pushed shares (NASDAQ:CELG) up 48 cents, to close at $59.96 on Thursday.

And it didn't stop there. Celgene added icing to the cake by upping its full year 2011 guidance. The biotech said revenues will be $4.6 billion to $4.7 billion rather than $4.45 billion to $4.55 billion and non-GAAP earnings per share will be $3.45 to $3.55 rather than $3.35 to $3.40.

Holley said Celgene "remains the premier growth story in large-cap biotech," and that growth looks sustainable thanks to label expansion plans and a strong pipeline.

In the second half of the year, Celgene plans to apply for FDA approval of Revlimid in newly diagnosed multiple myeloma (the drug is currently cleared for second-line), and programs are ongoing for prostate cancer, mantle cell lymphoma, and other new indications. Meanwhile, Abraxane is being studied for melanoma, pancreatic cancer, bladder cancer and ovarian cancer, and an approval filing in lung cancer is expected.

Autoimmune drug apremilast also is making its way onto the radar, with six Phase III trials for psoriatic arthritis and psoriasis more than halfway enrolled, and other programs under way for arthritis and ankylosing spondylitis.