Biogen's Tecfidera drives rosy Q3 results, higher forecast

Biogen Idec CEO George Scangos

The third-quarter numbers are in for Biogen Idec's multiple sclerosis pill Tecfidera, and once again, they're higher than anyone predicted. In its second quarter on the market, the drug handily beat out analyst expectations, making it 2-for-2 in that department and allowing Biogen ($BIIB) to hike its full-year guidance. And analysts don't expect it to stop there.

Sales for Tecfidera reached $286 million for the quarter, far higher than the $205 million or so that analysts forecast. That revenue mark pushed net profit up 22% to $488 million, up from $398 million last year. It also helped Biogen raise its outlook, and the company now predicts $8.65 to $8.85 a share rather than the $8.25 to $8.50 a share it announced in July. Biogen expects revenue growth of 23% to 25% for the year.

"We believe the continued growth of Tecfidera is a testament to its value to patients and physicians, and we are pleased with how it has complemented our robust portfolio of MS therapies," CEO George Scangos said in a statement.

Tecfidera has so far vastly outshone those counterparts in Biogen's MS lineup, including Avonex and Tysabri. After rolling out in April, it posted $192.1 million in sales in its first quarter on the market, breezing past analyst expectations on the way to one of the most successful launches this year. Solid trial data showing the drug's ability to cut the annual relapse rate and slow progression to disability helped propel it as it started its quest for peak sales of $3.78 billion.

Tecfidera has also handled competition from rival MS pills with ease. It has already eclipsed Sanofi's ($SNY) Aubagio and Novartis' ($NVS) Gilenya--its oral predecessors--in terms of market share, commanding 13% on its own compared with their combined 12.3%. It lacks the liver and heart-rate concerns that have plagued those two drugs, respectively, and Biogen priced it below Gilenya's $58,000 sticker at $54,900 per year.

Last week, data from a new reimbursement study suggested Tecfidera may not be relinquishing that market share any time soon. Leerink Swann analyst Marko Kozul noted that insurers had established "robust coverage" for the drug unusually quickly, which could keep patients coming its way. Those who have been denied reimbursement can get a year's worth of the drug for free from Biogen, another factor that could help the company hold onto patients at Sanofi and Novartis' expense.

- read Biogen's release
- see the WSJ's take (sub. req.)

Special Report: Top 15 Drug Launch Superstars - Tecfidera | 20 Highest-Paid Biopharma CEOs - George Scangos

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