Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its full year and fourth quarter 2009 results.
“non-GAAP net income attributable to Biogen Idec, Inc.”
Full Year 2009 Highlights:
- Total revenues in 2009 were $4.4 billion, an increase of 7% versus 2008. The increase was driven primarily by the continued growth of TYSABRI® (natalizumab) revenues, which increased 32% to $776 million, and AVONEX® (interferon beta-1a) revenues, which increased 5% to $2.3 billion. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement decreased 3% to $1.1 billion for the year due to the expiration of royalties on sales outside the United States.
- Global in-market 2009 TYSABRI net sales were $1.1 billion, an increase of 30% over 2008. The total was comprised of $509 million in U.S. sales and $551 million in sales to rest of world markets.
- On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full-year 2009 diluted earnings per share (EPS) were $3.35, an increase of 26% over 2008. GAAP net income attributable to Biogen Idec for 2009 was $1.0 billion, an increase of 24% over 2008.
- Non-GAAP diluted EPS for 2009 were $4.12, an increase of 13% over 2008. Non-GAAP net income attributable to Biogen Idec for 2009 was $1.2 billion, an increase of 11% over 2008. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
“Biogen Idec delivered strong financial and operational performance in 2009. We recorded our sixth consecutive year of double-digit EPS growth, TYSABRI became Biogen Idec’s third blockbuster product and we advanced two programs into registrational trials,” said James C. Mullen, Biogen Idec’s President and CEO. “We are confident that our continued focus on our products, robust pipeline and disciplined use of cash will fuel future earnings growth and drive value for Biogen Idec shareholders.”
Fourth Quarter 2009 Highlights:
- Fourth quarter revenues were $1.1 billion, an increase of 5% over the fourth quarter of 2008, driven primarily by the continued growth of TYSABRI revenues, which increased 39% to $216 million in the quarter, and AVONEX revenues, which increased 5% to $596 million. RITUXAN revenues decreased 15% to $257 million.
- Global in-market net sales of TYSABRI in the fourth quarter of 2009 were $296 million, an increase of 37% over the fourth quarter of 2008, of which $137 million were in the U.S. and $159 million were in rest of world markets.
- Fourth quarter 2009 GAAP diluted EPS were $1.06, an increase of 51% over the fourth quarter of 2008. GAAP net income attributable to Biogen Idec for the quarter was $306 million, an increase of 48% over the fourth quarter of 2008.
- Fourth quarter 2009 non-GAAP diluted EPS were $1.20, an increase of 29% over the fourth quarter of 2008. Non-GAAP net income attributable to Biogen Idec for the quarter was $345 million, an increase of 26% over the fourth quarter of 2008. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As of December 31, 2009 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.5 billion.
During the fourth quarter of 2009, Biogen Idec repurchased 14.8 million shares of stock at a total cost of $694 million. Two share repurchase authorizations accounted for the activity as follows:
- Biogen Idec repurchased the 6.0 million shares remaining from its 2006 share repurchase authorization at a cost of $271 million. The 2006 share repurchase program was used principally for share stabilization.
- In October 2009 the Board authorized a $1 billion share repurchase program; Biogen Idec purchased 8.8 million shares for a total of $422 million under this authorization. These shares have been retired.
During the first quarter of 2010 to February 5, 2010, we purchased an additional 5.4 million shares for a total of $289 million under the October 2009 share repurchase authorization. There is $288 million remaining under this program.
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other third-party sources as of the end of December 2009, we estimate that approximately 48,800 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 64,600 patients have ever been treated with TYSABRI in the post-marketing setting.
Other Products and Royalties
Revenues from other products in the fourth quarter of 2009 were $14 million, as compared to $10 million in the fourth quarter of 2008. Revenues from other products for the full year of 2009 were $54 million as compared to $49 million in 2008.
Table 4 provides individual product revenues.
Royalties were $41 million in the fourth quarter of 2009 compared to $29 million in the fourth quarter of 2008. Royalties for the full year 2009 were $124 million as compared to $116 million in 2008.
Biogen Idec also outlined its 2010 financial guidance. This guidance excludes any significant business development activities and consists of the following components:
- Revenue growth in 2010 is expected to be in the mid single digits.
- Core operating expense growth is expected to be in the low single digits.
- R&D is expected to be approximately 24% to 27% of total revenue.
- SG&A is expected to be approximately 20% to 22% of total revenue.
- GAAP EPS is expected to be above $3.71.
- Non-GAAP diluted EPS is expected to be above $4.55.
- We expect capital expenditures in the range of $170 to $200 million.
Biogen Idec may incur charges, realize gains or experience other events in 2010 that could cause actual results to vary from this guidance.
- On February 8, 2010, Biogen Idec announced that John R. Richert, M.D., and Nancy D. Richert, M.D., Ph.D., will be joining the company. Dr. John Richert joins Biogen Idec from the National Multiple Sclerosis Society, where he served as executive vice president for Research and Clinical Programs. Dr. Nancy Richert M.D., Ph.D., most recently served as a staff clinician at the National Institute of Neurological Disorders and Stroke and on the consulting staff at the Children's National Medical Center.
- On January 28, 2010, Biogen Idec reported that it had received a notice from Icahn Partners LP and certain of its affiliates for the nomination of three individuals, Thomas F. Deuel, Eric K. Rowinsky and Richard A. Young, to Biogen Idec’s Board of Directors at the company’s 2010 annual meeting of stockholders. The notice also includes a proposal to amend Biogen Idec’s bylaws to set the size of the Board of Directors at 12.
- On January 25, 2010, Biogen Idec and Swedish Orphan Biovitrum announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies' long-acting, recombinant Factor IX Fc fusion protein in hemophilia B patients.
- On January 12, 2010, Biogen Idec announced the submission of a marketing authorization application to the European Medicines Agency for Fampridine Prolonged Release tablets, a novel oral therapy for the improvement of walking ability in adult patients with multiple sclerosis (MS). The company announced it had also filed a New Drug Submission to Health Canada.
- On January 11, 2010, Biogen Idec and its partner Elan Pharmaceuticals, Inc. announced that Baron Baptiste, bestselling author and founder of Baptiste Power Vinyasa Yoga, and Dr. Elliot Frohman, one of the world’s leading authorities on MS, had teamed up to develop My MS Yoga, a new program created especially for people with MS.
- On January 7, 2010, Biogen Idec announced that Francesco Granata had been named Executive Vice President of Global Commercial Operations. In addition, Tony Kingsley was appointed Senior Vice President of U.S. Commercial Operations, and Dr. Frederick Munschauer was named Vice President of U.S. Medical Affairs. Dr. Granata most recently served as a Group Vice President at Schering-Plough Corp. Mr. Kingsley most recently served as Senior Vice President and General Manager, GYN Surgical Products at Hologic, Inc. Dr. Munschauer, a distinguished neurologist and professor, joins Biogen Idec from SUNY at Buffalo School of Medicine.
- On January 4, 2010, Biogen Idec announced that James C. Mullen, President and CEO, will retire from his position effective June 8, 2010. Mr. Mullen will also retire from Biogen Idec’s Board of Directors upon the completion of his current term as a Director at Biogen Idec’s 2010 Annual Stockholders Meeting. Biogen Idec also announced it had initiated a search for Mr. Mullen's successor.
- On January 4, 2010, Biogen Idec announced the appointment of Caroline Dorsa, Executive Vice President and Chief Financial Officer of Public Service Enterprise Group (PSEG) and former Senior Vice President, Global Human Health, Strategy and Integration at Merck & Co., Inc., to its Board of Directors.
- On December 10, 2009, Biogen Idec announced that William D. Young would become Chairman of Biogen Idec’s Board of Directors, effective January 1, 2010. The appointment followed the decision by Bruce R. Ross, 68, Biogen Idec’s Chairman since December 2005, to step down as Chairman, effective January 1, 2010.
- On December 10, 2009, Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec announced that a Phase 3 study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by criteria, known as the ACR 20 response, established by the American College of Rheumatology) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks.
- On December 7, 2009, Genentech and Biogen Idec announced that a three-year follow up of the pivotal Phase 3 CLL8 trial showed RITUXAN plus fludarabine and cyclophosphamide (FC) chemotherapy helped patients in the trial with previously untreated chronic lymphocytic leukemia (CLL) live longer than FC alone.
- On November 18, 2009, Genentech and Biogen Idec announced that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for RITUXAN plus FC for the treatment of CLL. The FDA did not request any new data to complete its review of these applications. Genentech and Biogen Idec have engaged in final label discussions with the FDA and expect to finalize these discussions during the first quarter of 2010.
- On October 17, 2009, Genentech and Biogen Idec announced that the companies received a complete response letter from the FDA for a supplemental Biologics License Application (sBLA) for RITUXAN plus MTX in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX. The FDA approved an additional sBLA submission to include updated safety and efficacy data in the label that provides guidance on how later-stage patients, those who have inadequately responded to tumor necrosis factor (TNF)-antagonist therapies, can be retreated with RITUXAN. The prescribing information now includes language that subsequent courses of the standard RITUXAN regimen (two doses at 1,000 mg each) can be administered every 24 weeks or based on clinical evaluation. Subsequent courses should not be administered sooner than 16 weeks. RITUXAN’s ability to improve physical function and slow joint damage for up to two years as demonstrated in clinical studies was also added.
Conference Call and Webcast
The company's earnings conference call for the fourth quarter will be broadcast via the internet at 8:30 a.m. ET on February 9, 2010, and will be accessible through the Investors section of Biogen Idec's homepage, http://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 earnings conference call and will be available on our web site subsequently through March 19, 2010.