On January 4, 2013, Biogen Idec announced the company recently submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. rFIXFc is the first product candidate in a new class of long-lasting clotting factor therapies that are being developed with the goals of reducing the burden of treatment for this condition and enhancing protection from bleeding. The regulatory submission was based on results from B-LONG, the largest registrational Phase 3 clinical study in hemophilia B to date.
On January 3, 2013, Biogen Idec reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS). The trial did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival. The trial also failed to show efficacy in its key secondary endpoints. Additional analyses of multiple subpopulations failed to demonstrate any efficacy among these groups. Based on these results, Biogen Idec has discontinued development of dexpramipexole in ALS.
2013 Financial Guidance
Biogen Idec also announced its full year 2013 financial guidance. This guidance consists of the following components:
- Revenue growth is expected to be approximately 10%.
- Cost of Sales is expected to be approximately 8% to 10% of total revenue.
- R&D expense is expected to be approximately 22% to 23% of total revenue.
- SG&A expense is expected to be approximately 24% to 26% of total revenue.
- Tax expense is expected to be approximately 24% to 26% of pretax income.
- Non-GAAP diluted EPS is expected to be between $7.15 and $7.25.
- GAAP diluted EPS is expected to be between $6.45 and $6.55.
- Capital expenditures are expected to be in the range of $250 to $270 million.