-- Non-GAAP Diluted EPS Rises 19%; GAAP Diluted EPS Up 17% --
-- Long-lasting Factor IX Hemophilia Candidate Reaches Primary Safety and Efficacy Endpoints in Phase 3 Trial --
-- Focus Remains on Commercial Execution, Investing in Future Success, Preparing for Upcoming Milestones --
WESTON, Mass.--(BUSINESS WIRE)-- Biogen Idec Inc. (NASDAQ: BIIB) today announced third quarter 2012 financial results, delivering revenue growth of 6 percent to $1.4 billion and non-GAAP diluted Earnings Per Share (EPS) growth of 19 percent.
Third Quarter 2012 Highlights:
- AVONEX® (interferon beta-1a) revenues increased 8 percent year-over-year to $736 million. TYSABRI® (natalizumab) revenues were $275 million, a decrease of 1 percent, compared to the third quarter of 2011. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $288 million for the quarter, an increase of 8 percent year-over-year.
- Global in-market sales of TYSABRI in the third quarter of 2012 were $404 million, an increase of 3 percent over the third quarter of 2011. The total was comprised of $230 million in United States sales and $173 million in sales outside the U.S.
- During the third quarter, Biogen Idec recognized a gain of $32 million in relation to the sale of our royalty and other rights related to BENLYSTA® (belimumab) to a DRI Capital managed fund (DRI). Under the terms of the agreement, Biogen Idec will receive a multiple on certain royalties payable to DRI for the period covering October 2011 through September 2014. The initial amount recognized covers the royalty period from October 1, 2011 through June 30, 2012.
- Third quarter 2012 GAAP diluted EPS was $1.67, an increase of 17 percent as compared to the third quarter of 2011. GAAP net income attributable to Biogen Idec for the quarter was $398 million, an increase of 13 percent as compared to the third quarter of 2011.
- Non-GAAP diluted EPS for the third quarter of 2012 was $1.91, an increase of 19 percent as compared to the third quarter of 2011. Non-GAAP net income attributable to Biogen Idec for the third quarter of 2012 was $455 million, an increase of 15 percent as compared to the third quarter of 2011. A reconciliation of our GAAP to non-GAAP results is included in Table 3 within this press release.
As of September 30, 2012, Biogen Idec had cash, cash equivalents and marketable securities of approximately $3.3 billion.
“Through the first three quarters of 2012, Biogen Idec is on track to accomplish what we set out to do at the beginning of the year,” said George A. Scangos, Ph.D., chief executive officer. “We have enhanced our leadership position in the multiple sclerosis market with strong results from AVONEX and TYSABRI; we have advanced our late-stage pipeline, with positive results from the registrational study for factor IX in hemophilia B; and we continue preparations for the potential launch of BG-12 next year. We look forward to data readouts for factor VIII in hemophilia A soon, followed by dexpramipexole in ALS and PEGylated interferon in relapsing MS in the coming months. Our hard work is reflected in this quarter’s results.”
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other third party sources, as of the end of September 2012, we estimate that approximately 71,100 patients are on commercial and clinical TYSABRI therapy worldwide, and that cumulatively, approximately 108,300 patients have been treated with TYSABRI in the post-marketing setting.
Other Products and Royalty Revenues
Revenues from other products in the third quarter of 2012 were $28 million, compared to $17 million in the third quarter of 2011.
Table 4 provides individual product revenues.
Royalty revenues were $47 million in the third quarter of 2012, compared to $52 million in the third quarter of 2011.
For the third quarter of 2012, corporate partner revenues were $12 million, compared to $16 million in the third quarter of 2011.
Updated 2012 Financial Guidance
Biogen Idec also updated its full year 2012 financial guidance. This guidance consists of the following components:
- Revenue growth is expected to be in the mid to high-single digits versus 2011.
- Cost of Sales is expected to be approximately 9 percent to 10 percent of total revenue.
- R&D expense is expected to be approximately 24 percent to 25 percent of total revenue. R&D expense is inclusive of approximately $20 to $30 million of a potential upfront payment in the fourth quarter earmarked for a discovery collaboration which we are in the process of negotiating.
- SG&A expense is expected to be approximately 22 percent to 23 percent of total revenue.
- Tax expense is expected to be approximately 23 percent to 25 percent of pretax income.
- Non-GAAP diluted EPS is expected to be between $6.40 and $6.50.
- GAAP diluted EPS is expected to be between $5.63 and $5.73.
- Capital expenditures are expected to be in the range of $230 to $250 million.
Biogen Idec may incur charges, realize gains or experience other events in 2012 that could cause actual results to vary from this guidance.
- On October 18, Biogen Idec announced the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The three month extension is a standard extension period. The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency did not ask for additional studies.
- On October 10, Biogen Idec presented extensive data from the company’s leading MS franchise during the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France. Fifty-three poster and platform presentations further showcased Biogen Idec’s commitment to advancing the treatment of MS and improving the lives of people living with the disease around the world. Approved and investigational therapies in Biogen Idec’s MS franchise presented at the conference included BG-12, daclizumab-HYP, anti-LINGO, TYSABRI, AVONEX and FAMPYRA® (prolonged-release fampridine tablets).
Third Quarter Events
- On September 26, Biogen Idec and Swedish Orphan Biovitrum (Sobi) announced positive top-line results from a Phase 3 study investigating long-lasting recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B. The primary efficacy and safety objectives were met and Biogen Idec plans to submit a Biologics License Application to the FDA by the first quarter of 2013.
- On September 19, Biogen Idec announced that the September 20, 2012 issue of the New England Journal of Medicine (NEJM) published detailed results from two pivotal clinical trials that evaluated oral BG-12 for the treatment of MS. Results of the Phase 3 DEFINE and CONFIRM studies support BG-12’s potential as a new oral option for MS treatment.
Conference Call and Webcast
The company's earnings conference call for the third quarter will be broadcast via the internet at 8:00 a.m. ET on October 25, 2012, and will be accessible through the Investors section of Biogen Idec's homepage, www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the conference call and will be subsequently available on the website for one month.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with MS in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with MS.
Symptoms of depression, suicidal ideation, or psychosis, and cases of suicide, have been reported with increased frequency with patients receiving AVONEX. Severe hepatic injury, including cases of hepatic failure has been reported rarely in patients. Rare cases of anaphylaxis have been reported. While beta interferons do not have any known direct cardiac toxicity, cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition. Decreased peripheral blood counts have been reported from postmarketing experience. Seizures have been reported in patients using AVONEX, including patients with no prior history of seizure. Autoimmune disorders of multiple target organs have been reported. Routine periodic blood chemistry, hematology, liver function, and thyroid function tests are recommended. There are no adequate and well-controlled studies in pregnant women. AVONEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The most common side effects associated with AVONEX treatment are flu-like symptoms, including chills, fever, myalgia, and asthenia.
For additional important safety information, and the complete United States full prescribing information, please visit www.AVONEX.com.
TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.
TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p