-- First Quarter Non-GAAP Diluted EPS Rose 41% and GAAP Diluted EPS Up 43% --
-- TECFIDERA™ (Dimethyl Fumarate) Approved and Launched in the US as a First-Line Oral Treatment for Relapsing Forms of Multiple Sclerosis; EU Approval Pending --
-- Gained Full Strategic, Commercial and Decision-Making Rights to TYSABRI® --
First quarter 2013 GAAP diluted EPS were
Revenue gains were led by the performance of our marketed therapies:
AVONEX® (interferon beta-1a) with revenues increasing 13%
“2013 is off to an exciting start for
“We also are preparing for the potential launches in 2014 of our long-lasting clotting factor therapies for hemophilia, rFVIIIFc and rFIXFc,” he continued. “We believe these therapies have the potential to transform the standard of care for hemophilia patients around the world. Our entire organization is aligned behind our focused mission and executing well in every aspect of the business – from launching new products to advancing our deep early-stage pipeline.”
Other Financial Highlights
During the first quarter of 2013, we received updated technical
guidance from the
IRSconcerning our U.S. federal manufacturing deduction related to our unconsolidated joint business. Based on this guidance, we reevaluated our manufacturing deduction and recorded a $33 millionbenefit, which is net of ancillary federal and state tax effects, related to the years 2005 through 2012, in the first quarter of 2013. We also experienced modest favorability due to the reinstatement of the federal R&D tax credit and the award of a state life science tax credit. As a result, Biogen Idecbenefited from low GAAP and non-GAAP tax rates of 13.2% and 14.0%, respectively. These unusually low tax rates benefited our non-GAAP EPS by approximately $0.17and GAAP EPS by approximately $0.16.
Our share of RITUXAN revenues from our unconsolidated joint business
was reduced by approximately
$42 millionduring the first quarter of 2013 as a result of damages awarded against Genentech in its arbitration with Hoechst GmbH.
Revenues for FAMPYRA® and FUMADERM™ totaled
$38 millionin the first quarter of 2013, compared to $28 millionin the first quarter of 2012.
$33 millionin the first quarter of 2013, an increase of 14% compared to the first quarter of 2012.
Corporate partner revenues in the first quarter of 2013 were
$22 million, compared to $3 millionin the first quarter of 2012.
March 31, 2013, Biogen Idechad Cash, Cash Equivalents and a Reverse Repurchase Agreement totaling approximately $3.6 billion, of which we used $3.25 billionto fund our acquisition of TYSABRI rights from Elan on April 2, 2013.
April 17, 2013, Standard & Poor’s raised Biogen Idec’s credit rating to A- from BBB+ reflecting the launch of TECFIDERA, greater TYSABRI revenue due to the close of the transaction with Elan, low leverage and strong and growing cash flow generation.
2013 Financial Guidance
- Revenue growth is expected to be approximately 16% to 18%.
- Cost of Sales is expected to be approximately 13% to 15% of total revenue.
- R&D expense is expected to be approximately 22% to 23% of total revenue.
R&D expense includes up to
$75 millionearmarked for potential new business development deals.
- SG&A expense is expected to be approximately 24% to 26% of total revenue.
- Tax expense is expected to be approximately 22% to 23% of pretax income.
Non-GAAP diluted EPS is expected to be between
$7.80 and $7.90.
GAAP diluted EPS is expected to be between
$6.69 and $6.79.
Capital expenditures are expected to be in the range of
$250 to $270 million.
Company anticipates an ending 2013 cash balance greater than
$1 billion, of which the majority will be located in the U.S.
“In the first quarter, we continued to drive solid performance while
making substantial progress moving our late-stage programs towards
approvals and launch,” said
Multiple Sclerosis (MS) Franchise Highlights
TECFIDERA (dimethyl fumarate)
The U.S. Food and Drug Administration’s (
TYSABRI revenues increased 9% year-over-year to
Based on data available to us through the TOUCH® prescribing
program and other third-party sources, as of the end of
AVONEX (interferon beta-1a)
AVONEX revenues increased 13% year-over-year to
Additional Pipeline Development Highlights
During the first quarter
March 2013, Biogen Idecsubmitted a Biologics License Application (BLA) to the FDAfor the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. Recombinant FVIIIFc is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of reducing the burden of treatment for this condition.
March 4, 2013, Biogen Idecannounced that the FDAaccepted the Company’s BLA for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the Company a standard review timeline.
February 8, 2013, Biogen Idecand Swedish Orphan Biovitrum(Sobi) released data at the 6th Annual Congress of the European Association for Haemophilia and Allied Disorders(EAHAD) in Warsaw, Poland. Data presented confirmed the ability of investigational rFVIIIFc and rFIXFc to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with hemophilia.
Conference Call and Webcast
The Company's earnings conference call for the first quarter will be
broadcast via the internet at
Through cutting-edge science and medicine,
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 full
TYSABRI is approved in more than 65 countries. TYSABRI is approved in
TYSABRI has advanced the treatment of MS patients with its established
efficacy. Data from the Phase 3 AFFIRM trial, which was published in the
TYSABRI increases the risk of PML, an opportunistic viral infection of the brain which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. 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 also been reported in the post-marketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved.
For additional important safety information, and the full TYSABRI prescribing information, please see www.TYSABRI.com.
TECFIDERA delayed-release capsules are indicated for the treatment of patients with relapsing forms of MS. TECFIDERA has been proven to reduce MS relapses, progression of disability and MS brain lesions. The efficacy and safety of TECFIDERA has been studied in a large, global clinical program with more than 3,600 MS patients, which includes an ongoing long-term extension study. It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in nature, and GI events (i.e., diarrhea, nausea, abdominal pain). These events are most common at the start of therapy and usually decrease over time.
TECFIDERA may decrease lymphocyte counts. Before starting treatment with TECFIDERA, a recent CBC (i.e., within six months) should be available. A CBC is recommended annually and as clinically indicated.
There are no adequate and well-controlled studies in pregnant women. TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
For additional important safety information, and the full TECFIDERA prescribing information, please see www.TECFIDERA.com.
This press release contains forward-looking statements, including statements about potential product launches, 2013 financial guidance, growth prospects, regulatory submissions and agency actions, and the development, commercialization and therapeutic impact of new and potential treatments. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including our dependence on our three principal products, AVONEX,
TYSABRI and RITUXAN, the importance of TYSABRI’s sales growth,
uncertainty of success in executing our commercial launch of TECFIDERA,
uncertainty of success in commercializing and developing other products,
product competition, the occurrence of adverse safety events with our
products, changes in the availability of reimbursement for our products,
adverse market and economic conditions, our dependence on collaborations
and other third parties over which we may not always have full control,
problems with our manufacturing processes and our reliance on third
parties, failure to comply with government regulation, our ability to
protect our intellectual property rights and have sufficient rights to
market our products together with the cost of doing so, the risks of
doing business internationally, failure to manage our growth and execute
our growth initiatives, charges and other costs relating to our
properties, fluctuations in our effective tax rate, our ability to
attract and retain qualified personnel, product liability claims,
fluctuations in our operating results, the market, interest and credit
risks associated with our portfolio of marketable securities,
environmental risks, change of control provisions in our 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
These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.
|Biogen Idec Inc. and Subsidiaries|
|Condensed Consolidated Statements of Income|
|(unaudited, in thousands, except per share amounts)|
|For the Three Months|
|Ended March 31,|
|Unconsolidated joint business||264,606||284,552|
|Cost and expenses:|
|Cost of sales, excluding amortization of acquired intangible assets||133,749||133,197|
|Research and development||284,340||355,962|
|Selling, general and administrative||352,598||300,089|
|Collaboration profit sharing||85,357||85,894|
|Amortization of acquired intangible assets||51,301||45,961|
|Fair value adjustment of contingent consideration||2,277||1,258|
Total cost and expenses
|Gain on sale of rights||5,051||-|
|Income from operations||510,525||369,370|
|Other income (expense), net||(14,457||)||15,144|
|Income before income tax expense and equity in loss of investee, net of tax||496,068||384,514|
|Income tax expense||65,508||82,148|
|Equity in loss of investee, net of tax||3,811||-|
|Net income (loss) attributable to non-controlling interests, net of tax||-||(295||)|
|Net income attributable to Biogen Idec Inc.||$||426,749||$||302,661|
|Net income per share:|
|Basic earnings per share attributable to Biogen Idec Inc.||$||1.80||$||1.26|
|Diluted earnings per share attributable to Biogen Idec Inc.||$||1.79||$||1.25|
|Weighted-average shares used in calculating:|
|Basic earnings per share attributable to Biogen Idec Inc.||236,837||239,754|
|Diluted earnings per share attributable to Biogen Idec Inc.||238,304||241,828|
|Biogen Idec Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets|
|(unaudited, in thousands)|
|As of||As of|
|March 31,||December 31,|
Cash, cash equivalents, reverse repurchase
|Accounts receivable, net||753,611||686,848|
|Other current assets||437,368||404,406|
|Total current assets||5,328,838||3,244,337|
|Property, plant and equipment, net||1,736,811||1,742,226|
|Intangible assets, net||1,581,511||1,631,547|
|Investments and other assets||306,839||274,054|
|LIABILITIES AND EQUITY|
|Current portion of notes payable and line of credit||$||203,317||$||453,379|
|Other current liabilities||1,078,345||1,204,010|
|Long-term deferred tax liability||156,667||217,272|
|Notes payable, line of credit and other financing arrangements||711,831||687,396|
|Other long-term liabilities||674,951||604,266|
|TOTAL LIABILITIES AND EQUITY||$||10,164,717||$||10,130,118|
|Biogen Idec Inc. and Subsidiaries|
|GAAP to Non-GAAP Reconciliation: Net Income and Net Income Per Share|
|(unaudited, in millions, except per share amounts)|
For the Three Months
Ended March 31,
|EARNINGS PER SHARE||2013||2012|
|GAAP earnings per share - Diluted||$||1.79||$||1.25|
|Adjustments to net income attributable to Biogen Idec Inc. (as detailed below)||0.18||0.15|
|Non-GAAP earnings per share - Diluted||$||1.97||$||1.40|
|An itemized reconciliation between net income attributable to Biogen Idec Inc. on a GAAP basis and net income attributable to Biogen Idec Inc. on a non-GAAP basis is as follows:|
|GAAP net income attributable to Biogen Idec Inc.||$||426.7||$||302.7|
|Amortization of acquired intangible assets||48.6||43.3|
|Fair value adjustment of contingent consideration||2.3||1.3|
|SG&A: Stock option expense||1.9||0.4|
|R&D: Stock option expense||1.6||1.0|
|R&D: Restructuring and other||-||1.3|
|2010 Restructuring initiatives||-||0.3|
|Income tax effect related to reconciling items||(11.7||)||(11.6||)|
|Non-GAAP net income attributable to Biogen Idec Inc.||$||469.4||$||338.4|
|2013 Full Year Guidance GAAP to non-GAAP adjustments|
|An itemized reconciliation between projected EPS on a GAAP basis and on a non-GAAP basis is as follows:|
|Projected GAAP net income attributable to Biogen Idec Inc.||$||1,608||239||$||6.74|
|Stock option expense||8|
|Restructuring and other||-|
|Amortization of acquired intangible assets||314|
|Fair value adjustment of contingent consideration||16|
|Income tax expense: Income tax effect related to reconciling items||(74||)|
|Projected Non-GAAP net income attributable to Biogen Idec Inc.||$||1,872||239||$||7.85|
Use of Non-GAAP Financial Measures
We supplement our consolidated financial statements presented on a GAAP
basis by providing additional measures which may be considered
“non-GAAP” financial measures under applicable
Our “Non-GAAP net income attributable to Biogen Idec Inc.” and “Non-GAAP
earnings per share - Diluted” financial measures exclude the following
items from GAAP net income attributable to
1. Purchase accounting and merger-related adjustments.
We exclude certain purchase accounting related items associated with the acquistion of businesses, assets and amounts in relation to the consolidation of variable interest entities for which we are the primary beneficiary. These adjustments include charges for in-process research and development, the amortization of certain acquired intangible assets and adjustments to the fair value of our contingent consideration obligations. The exclusion of these charges provides management and investors with a supplemental measure of performance which the Company believes better reflects the underlying economics of the business.
2. Stock option expense recorded in accordance with the accounting standard for share-based payments.
We believe that excluding the impact of expensing stock options better reflects the recurring economic characteristics of our business.
3. Other items.
We evaluate other items on an individual basis, and consider both the
quantitative and qualitative aspects of the item, including (i) its size
and nature, (ii) whether or not it relates to our ongoing business
operations, and (iii) whether or not we expect it to occur as part of
our normal business on a regular basis. We also include an adjustment to
reflect the related tax effect of all reconciling items within our
reconciliation of our GAAP to Non-GAAP net income attributable to
Numbers may not foot due to rounding.
|Biogen Idec Inc. and Subsidiaries|
|(unaudited, in thousands)|
|For the Three Months|
|Ended March 31,|
|Total product revenues||$||1,095,779||$||975,488|
Biogen Idec Media Contact:
Amanda Galgay, 781-464-3260
Senior Manager, Public Affairs
Daniel McIntyre, 781-464-3260
Senior Vice President, Public Affairs
Biogen Idec Investor Contacts:
Ben Strain, 781-464-2442
Senior Manager, Investor Relations
Claudine Prowse, Ph.D., 781-464-2442
Vice President, Investor Relations