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Biogen Idec Inc. (NASDAQ: BIIB) today reported full year and fourth quarter 2013 results, including revenue of $6.9 billion, a 26% increase compared to the prior year. Full year 2013 non-GAAP diluted earnings per share (EPS) were $8.96, an increase of 37% over 2012. Non-GAAP net income attributable to Biogen Idec for the year was $2.1 billion, an increase of 36% over the year prior.
On a reported basis, GAAP diluted EPS for 2013 were $7.81, an increase of 36% over 2012. GAAP net income attributable to Biogen Idec for 2013 was $1.9 billion, an increase of 35% versus 2012. (A reconciliation of GAAP to Non-GAAP year-end and quarterly financial results and 2014 guidance can be found in Table 3 at the end of this release).
“2013 was a great year for Biogen Idec and the patients we serve,” said Chief Executive Officer George A. Scangos. “Our existing products continued to perform well and the rapid growth of TECFIDERA – from launch to its position today as the number one prescribed oral MS therapy in the US – is a testament to our ability to develop and effectively bring new drugs to patients.”
Dr. Scangos added, “We are entering an exciting period as we plan for three new potential product launches this year, including two treatments for patients with hemophilia and the first pegylated interferon for MS -- as well as the potential approval and launch of TECFIDERA in Europe. We also are looking forward to multiple clinical readouts this year that, if successful, may support bringing forward therapies that could have a meaningful impact for patients in areas where there are currently few or no treatment options.”
In 2014, Biogen Idec expects six data read-outs for several compounds currently in early-to-mid stage clinical trials. These include data from trials on the effectiveness of potential therapies for neurodegenerative and immunological diseases, including Alzheimer’s disease,
idiopathic pulmonary fibrosis, multiple sclerosis, spinal muscular atrophy and lupus.
Full Year 2013 Performance Highlights
AVONEX ® (interferon beta-1a) revenues increased 3% over 2012 to $3.0 billion. The total was comprised of $1.9 billion in U.S. sales and $1.1 billion in sales outside the U.S.
TYSABRI ® (natalizumab) revenues increased 34% year-over-year to $1.5 billion due to our recording of 100% of TYSABRI revenues following our acquisition of complete rights in TYSABRI from Elan in the second quarter of 2013. Global in-market sales of TYSABRI totaled $1.7 billion, increasing 3% when compared to the prior year. Total in-market sales included $958 million in the U.S. and $712 million in sales outside the U.S.
TECFIDERA ® (dimethyl fumarate) revenues totaled $876 million, consisting of $864 million in U.S. sales and $12 million in sales in Canada and Australia.
RITUXAN ® (rituximab) and GAZYVA TM (obinutuzumab) net revenues from our unconsolidated joint business arrangement were $1.1 billion a decrease of 1% compared to 2012.
Fourth Quarter 2013 Performance Highlights
Fourth quarter revenues increased 39% to $2.0 billion, compared to the fourth quarter of 2012.
AVONEX revenues were flat compared to the fourth quarter of 2012 at $751 million. The total was comprised of $475 million in U.S. sales and $277 million in sales outside the U.S.
TYSABRI revenues increased by 45% to $427 million as a result of recording 100% of TYSABRI revenues following our acquisition of complete rights for the therapy in the second quarter of 2013. Global in-market sales for TYSABRI for the fourth quarter decreased 1% compared to the fourth quarter of 2012. The final ratification of the settlement of our dispute with the Italian National Medicines Agency relating to TYSABRI sales did not occur during the fourth quarter and is still pending.
TECFIDERA revenues were $398 million. The total was comprised of $390 million in U.S. sales and approximately $7 million in sales outside the U.S. The Company estimates that approximately $42 million of U.S. TECFIDERA revenues represented incremental inventory in the channel. As a result, revenue generated in the U.S. from underlying patient demand was approximately $348 million.
RITUXAN and GAZYVA net revenues from our unconsolidated joint business arrangement were $269 million, a decrease of 4% compared to the fourth quarter of 2012.
GAAP diluted EPS were $1.92, an increase of 56% over the fourth quarter of 2012. GAAP net income attributable to Biogen Idec for the quarter was $457 million, an increase of 57% from the fourth quarter of 2012.
Non-GAAP diluted EPS were $2.34, an increase of 67% over the fourth quarter of 2012. Non-GAAP net income attributable to Biogen Idec for the fourth quarter of 2013 was $557 million, an increase of 66% from the fourth quarter of 2012.
Other Financial Highlights
Revenues for FAMPYRA ® and FUMADERM™ totaled $31 million in the fourth quarter of 2013 and $134 million for the full year, compared to $26 million in the fourth quarter of 2012 and $117 million for the full year 2012.
Royalty revenues totaled $61 million in the fourth quarter of 2013, compared to $56 million in the fourth quarter of 2012. For the full year, royalty revenues were $186 million, compared to $169 million for the full year 2012.
Corporate partner revenues totaled $29 million in the fourth quarter of 2013 compared to $6 million in the fourth quarter of 2012. For the full year, corporate partner revenues were $78 million compared to $44 million in 2012.
As of December 31, 2013, Biogen Idec had cash, cash equivalents and marketable securities totaling approximately $1.8 billion.
2014 Financial Guidance
Biogen Idec also announced its full year 2014 financial guidance. This guidance consists of the following components:
Revenue growth is expected to be approximately 22% to 25%.
R&D expense is expected to be approximately 20% to 22% of total revenue.
R&D expense includes over $200 million earmarked for potential new business development deals.
SG&A expense is expected to be approximately 22% to 23% of total revenue.
Non-GAAP diluted EPS is expected to be between $11.00 and $11.20.
GAAP diluted EPS is expected to be between $9.74 and $9.94.
GAAP diluted EPS is expected to include amortization of acquired intangible assets of approximately $415 million.
Capital expenditures are expected to be approximately $300 million.
Biogen Idec may incur charges, realize gains or experience other events in 2014 that could cause actual results to vary from this guidance.