Despite the distraction of unsuccessfully putting itself up for sale, Biogen Idec Inc. beat analyst estimates for earnings and revenues in the fourth quarter and full-year 2007, thanks to strong sales of Avonex (interferon beta-1a), Tysabri (natalizumab) and Rituxan (rituximab).
The Cambridge, Mass.-based company reported fourth-quarter non-GAAP net income of $266 million, up 45 percent over the fourth quarter of 2006. Earnings of $0.89 per share beat analyst expectations of $0.80 per share and represented a 68 percent increase over the fourth quarter of last year.
For the full year, non-GAAP net income was $879 million, up 13 percent over 2006. Earnings of $2.74 per share were up 22 percent over 2006 and beat analyst expectations of $2.66 per share.
Better-than-expected revenues contributed to the solid financials. Fourth-quarter revenues of $893 million were up 26 percent over the fourth quarter last year and beat analyst estimates of $836 million. Meanwhile full-year revenues of $3.17 billion were up 18 percent over 2006 and topped analyst estimates of $3.11 billion.
The majority of those revenues came from Biogen Idec's multiple sclerosis franchise, which includes Avonex and Tysabri. Market-leader Avonex posted sales of $1.87 billion in 2007, up 9 percent over 2006. With more than a million patients, it remains the most prescribed MS drug in the world.
But Tysabri seems to be gaining ground. After being pulled from the market in 2005 due to concerns about progressive multifocal leukoencephalopathy (PML), the drug was re-approved for MS in mid-2006. Biogen Idec said no cases of PML have surfaced since then, and Tysabri posted full-year 2007 sales of $229.8 million, with fourth-quarter revenues of $90 million representing a significant increase over fourth-quarter 2006 revenues of $17.6 million. (See BioWorld Today, June 6, 2006.)
Biogen Idec has big plans for Tysabri moving forward. The company intends to increase the number of patients on the drug from 21,000 in late December to 100,000 by the end of 2010. Some analysts have voiced concerns about that target and Tysabri's potential cannibalization of Avonex sales, which Biogen Idec's Senior Vice President of U.S. Neurology Bill Sibold addressed during the company's conference call. Sibold offered a chart showing that just 21 percent of U.S. Tysabri patients have switched from Avonex, while 44 percent have switched from other MS drugs and 35 percent are new to the MS treatment market.
Last month, Tysabri picked up an approval for moderate to severe Crohn's disease, and Biogen Idec expects to launch the drug in that indication this month. (See BioWorld Today, Jan. 15, 2008.)
Biogen Idec's other major source of revenue in 2007 was Rituxan, which brought the company $926 million. The drug is marketed for non-Hodgkin's lymphoma and rheumatoid arthritis through a partnership with Genentech Inc., and Phase III data expected later this year in multiple sclerosis, lupus and chronic lymphocytic leukemia could lay the groundwork for label expansions.
Additional long-term growth may come from Biogen Idec's ongoing pivotal programs with lumiliximab for chronic lymphocytic leukemia, galiximab for non-Hodgkin's lymphoma, and BG-12 for multiple sclerosis.
Drugs slated to begin pivotal trials this year include lixivaptan, the vasopressin antagonist for hyponatremia that Biogen Idec licensed from Cardiokine Inc., and Adentri, an adenosine A1 antagonist for heart failure.
Altogether, Biogen Idec has 15 products in Phase II or later clinical trials.
In the near term, Biogen Idec reiterated its 2008 guidance of non-GAAP earnings in the range of $3.20 to $3.35 per share and revenues running 15 percent to 20 percent higher than in 2007. Looking further out, Biogen Idec's CEO James Mullen predicted revenue growth of 15 percent and non-GAAP earnings growth of 20 percent between 2007 and 2010.
That four-year goal is exactly the same as the one Mullen set four years ago, when Biogen Inc. and IDEC Pharmaceuticals Inc. first merged. At the time, most analysts were less than excited about the deal, but Mullen said the company has "essential achieved its long-term growth goals," posting a 14.4 percent increase in revenues and a 22.4 percent increase in earnings during the past four years. (See BioWorld Today, June 24, 2003.)
Those results demonstrated that "the future of Biogen Idec is extremely bright" and that the company's business strategy is working, Mullen said. That's the conclusion the company's board of directors reached late last year after putting itself up for sale, completing a strategic review and deciding to remain an independent company. (See BioWorld Today, Oct. 16, 2007, and Dec. 14, 2007.)
On the subject of Biogen Idec's proposed sale, Mullen added that "despite all the Monday morning quarterbacking going on around this or that decision . . . the basic fact remains that no company put a bid on the table."
Shares of Biogen Idec (NASDAQ:BIIB) closed flat at $60.52 on Wednesday.