Biogen Idec Reports First Quarter 2010 Results Tysabri Revenues Increase 32% Year over Year
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 20, 2010 - Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its first quarter 2010 results.
First Quarter 2010 Highlights:
First quarter GAAP and non-GAAP results include a $14 million charge resulting from the impairment of our investment in AVEO Pharmaceuticals following its initial public offering in March of this year. First quarter results were also impacted by a $13 million charge due to the recently approved Patient Protection and Affordable Care Act. This is the result of expanded 340(B) pricing and increased Medicaid rebates mandated by this legislation.
As of March 31, 2010 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.2 billion.
“We continue to execute on our strategy and actively position Biogen Idec for future growth,” said James C. Mullen, Biogen Idec's President and CEO. “We have several efforts underway that have the potential to drive long-term TYSABRI adoption, including the JC virus assay and SURPASS comparative study, our pipeline has great prospects with six programs in registrational trials, and we have solid financial fundamentals with strong cash flow.”
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other third-party sources, Biogen Idec estimates that as of the end of March 2010 approximately 50,300 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 67,700 patients have ever been treated with TYSABRI in the post-marketing setting.
Other Products and Royalties
Revenues from other products in the first quarter of 2010 were $13 million, the same as in the first quarter of 2009.
Table 4 provides individual product revenues.
Royalties were $26 million in the first quarter of 2010 compared to $24 million in the first quarter of 2009.
Share Repurchase Programs
During the first quarter of 2010, Biogen Idec completed the $1 billion share repurchase program announced during the fourth quarter of 2009. The Company repurchased and retired 10.5 million shares at a total cost of $577.6 million during the quarter.
In April 2010, the Board of Directors authorized an additional $1.5 billion share repurchase program with the objective of returning excess cash to shareholders. The shares repurchased under this authorization will be retired. The authorization is open-ended and we expect that repurchases will be made over a longer period than our recently completed $1 billion share repurchase program.
Conference Call and Webcast
Biogen Idec's earnings conference call for the first quarter will be broadcast via the Internet at 8:30 a.m. ET on April 20, 2010, and will be accessible through the Investors section of 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 through May 21, 2010.
TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.
Data from the Phase 3 AFFIRM trial highlights TYSABRI's powerful efficacy. According to that data, which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54% (p<0.001). In post-hoc analyses of the Phase 3 AFFIRM trial and as published in The Lancet Neurology, 37% of TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures, compared to seven percent of placebo-treated patients.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use with limited experience beyond three years of treatment. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide, with nearly 140,000 patients on therapy. It is used worldwide as a treatment for relapsing forms of MS to slow the progression of physical disability and reduce relapses. AVONEX is also approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS.
The most common side effects associated with AVONEX MS treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.axonex.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
In addition to historical information, this press release contains forward-looking statements that are based on our current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those which we expect. Important factors which could cause actual results to differ from our expectations and which could negatively impact our financial position and results of operations include our dependence on our three principal products, AVONEX, RITUXAN and TYSABRI, the importance of TYSABRI's sales growth, competitive pressures, uncertainty of success in commercializing other products, the occurrence of adverse safety events with our products, changes in the availability of reimbursement for our products, our dependence on collaborations over which we may not always have full control, failure to execute our growth initiatives, failure to comply with government regulation and possible adverse impact of changes in such regulation, problems with our manufacturing processes and our reliance on third parties, charges and other costs relating to our properties, fluctuations in our effective tax rate, our ability to attract and retain qualified personnel, the risks of doing business internationally, proxy contests and representation of activist shareholders on our board of directors, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, fluctuations in our operating results, credit and financial market conditions, the market, interest and credit risks associated with our portfolio of marketable securities, our level of indebtedness, environmental risks, aspects of our corporate governance and collaborations and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC. Forward-looking statements, like all statements in this press release, speak only as of the date of this press release (unless another date is indicated). Unless required by law, we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
|Biogen Idec Inc.|
|March 31, 2010|
|Consolidated Statements of Income|
|(in thousands, except per share amounts)|
|Three Months Ended|
|Unconsolidated joint business||254,928||278,818|
|COST AND EXPENSES|
|Cost of sales||97,055||98,197|
|Research and development||307,030||279,478|
|Selling, general and administrative||248,664||221,830|
|Amortization of acquired intangible assets||48,889||89,248|
|Collaboration profit sharing||63,557||42,773|
|Acquired in-process research and development||39,976||-|
|Total cost and expenses||805,171||731,526|
|Income from operations||303,689||304,958|
|Other (expense), income net||(8,386||)||6,846|
|INCOME BEFORE INCOME TAX EXPENSE||295,303||311,804|
|Income tax expense||75,310||65,225|
|Less: Net income attributable to noncontrolling interest, net of tax||2,551||2,592|
|NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC.||$||217,442||$||243,987|
|BASIC EARNINGS PER SHARE||$||0.80||$||0.85|
|DILUTED EARNINGS PER SHARE||$||0.80||$||0.84|
|WEIGHTED-AVERAGE SHARES USED IN CALCULATING:|
|BASIC EARNINGS PER SHARE||269,922||287,703|
|DILUTED EARNINGS PER SHARE||272,703||289,744|
|Biogen Idec Inc.|
|March 31, 2010|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and marketable securities||$||1,152,674||$||1,263,724|
|Accounts receivable, net||560,777||551,208|
|Other current assets||415,523||371,713|
|Total current assets||2,409,012||2,480,595|
|Property, plant and equipment, net||1,604,573||1,637,083|
|Intangible assets, net||1,822,133||1,871,078|
|Investments and other assets||210,761||230,397|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Current portion of notes payable and line of credit||$||19,115||$||19,762|
|Other current liabilities||663,215||695,180|
|Long-term deferred tax liability||248,898||240,618|
Posted: April 2010