BIOGEN IDEC 2013 TOTAL REVENUES INCREASE 26 PERCENT TO $6.9 BILLION
- 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 GAZYVATM (obinutuzumab) net revenues from our unconsolidated joint business arrangement were $1.1 billion a decrease of 1% compared to 2012.
- 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.
- 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.
- 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.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency determined that the dimethyl fumarate in TECFIDERA qualifies as a new active substance. This designation will provide 10 years of regulatory exclusivity for TECFIDERA in the European Union. This determination follows a positive opinion for TECFIDERA by the CHMP in March 2013 as a first line oral treatment for people with relapsing-remitting multiple sclerosis, the most common form of multiple sclerosis. The CHMP's determination has now been referred to the European Commission, which grants marketing authorization for medicines in the EU.
- Biogen Idec and its partner Swedish Orphan Biovitrum AB made three announcements including:
- Biogen Idec announced that it exercised its right to enter into an agreement with joint venture partner Samsung Bioepis to commercialize anti-TNF biosimilar product candidates in Europe, including biosimilars for widely used therapies to treat conditions such as rheumatoid arthritis and Crohn's disease. Under the agreement, Biogen Idec will be responsible for commercialization of these product candidates across Europe.
- Subsequent to the end of 2013, Biogen Idec entered into an exclusive worldwide collaboration and license agreement with Sangamo BioSciences focused on the development of therapeutics for hemoglobinopathies, inherited conditions that result from the abnormal structure or underproduction of hemoglobin. The agreement will enable Biogen Idec to further enhance its expertise in non-malignant hematology by leveraging Sangamo's proprietary genome-editing technology platform to develop treatments targeting sickle cell disease and beta-thalassemia. This transaction is subject to customary closing conditions.
- In November 2013, Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved GAZYVA (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia. GAZYVA is the first medicine approved with the FDA's Breakthrough Therapy Designation. Under Biogen Idec's agreement with Genentech, Biogen Idec is responsible for 35% of the development and commercialization expenses of GAZYVA and receives between 35% and 39% of the profits of GAZYVA based upon the achievement of certain sales milestones.
TABLE 1 | |||||||||||||||||||||||||
Biogen Idec Inc. and Subsidiaries | |||||||||||||||||||||||||
Condensed Consolidated Statements of Income | |||||||||||||||||||||||||
(unaudited, in thousands, except per share amounts) | |||||||||||||||||||||||||
For the Three Months | For the Twelve Months | ||||||||||||||||||||||||
Ended December 31, | Ended December 31, | ||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Product, net | $ | 1,607,080 | $ | 1,074,676 | $ | 5,542,331 | $ | 4,166,074 | |||||||||||||||||
Unconsolidated joint business | 269,416 | 280,948 | 1,126,017 | 1,137,923 | |||||||||||||||||||||
Royalty | 60,613 | 56,170 | 185,689 | 168,679 | |||||||||||||||||||||
Corporate partner | 28,741 | 6,147 | 78,162 | 43,785 | |||||||||||||||||||||
Total revenues | 1,965,850 | 1,417,941 | 6,932,199 | 5,516,461 | |||||||||||||||||||||
Cost and expenses: | |||||||||||||||||||||||||
Cost of sales, excluding amortization of acquired intangible assets | 258,553 | 133,828 | 857,726 | 545,494 | |||||||||||||||||||||
Research and development | 422,233 | 345,180 | 1,444,053 | 1,334,919 | |||||||||||||||||||||
Selling, general and administrative | 522,857 | 375,977 | 1,712,051 | 1,277,465 | |||||||||||||||||||||
Amortization of acquired intangible assets | 109,424 | 50,948 | 342,948 | 202,204 | |||||||||||||||||||||
Collaboration profit sharing | - | 77,944 | 85,357 | 317,895 | |||||||||||||||||||||
(Gain) loss on fair value remeasurement of contingent consideration | 2,436 | 3,630 | (547 | ) | 27,202 | ||||||||||||||||||||
Restructuring charge | - | - | - | 2,225 | |||||||||||||||||||||
Total cost and expenses | 1,315,503 | 987,507 | 4,441,588 | 3,707,404 | |||||||||||||||||||||
Gain on sale of rights | 7,579 | 15,073 | 24,898 | 46,792 | |||||||||||||||||||||
Income from operations | 657,926 | 445,507 | 2,515,509 | 1,855,849 | |||||||||||||||||||||
Other income (expense), net | (5,405 | ) | (14,290 | ) | (34,930 | ) | (744 | ) | |||||||||||||||||
Income before income tax expense and equity in loss of investee, net of tax | 652,521 | 431,217 | 2,480,579 | 1,855,105 | |||||||||||||||||||||
Income tax expense | 190,261 | 136,341 | 601,014 | 470,554 | |||||||||||||||||||||
Equity in loss of investee, net of tax | 4,954 | 2,749 | 17,224 | 4,518 | |||||||||||||||||||||
Net income | 457,306 | 292,127 | 1,862,341 | 1,380,033 | |||||||||||||||||||||
Net income attributable to non-controlling interests, net of tax | - | - | - | - | |||||||||||||||||||||
Net income attributable to Biogen Idec Inc. | $ | 457,306 | $ | 292,127 | $ | 1,862,341 | $ | 1,380,033 | |||||||||||||||||
Net income per share: | |||||||||||||||||||||||||
Basic earnings per share attributable to Biogen Idec Inc. | $ | 1.94 | $ | 1.23 | $ | 7.86 | $ | 5.80 | |||||||||||||||||
Diluted earnings per share attributable to Biogen Idec Inc. | $ | 1.92 | $ | 1.23 | $ | 7.81 | $ | 5.76 | |||||||||||||||||
Weighted-average shares used in calculating: | |||||||||||||||||||||||||
Basic earnings per share attributable to Biogen Idec Inc. | 236,283 | 236,612 | 236,919 | 237,938 | |||||||||||||||||||||
Diluted earnings per share attributable to Biogen Idec Inc. | 237,627 | 238,324 | 238,308 | 239,740 | |||||||||||||||||||||
TABLE 2 | ||||||||||||
Biogen Idec Inc. and Subsidiaries | ||||||||||||
Condensed Consolidated Balance Sheets | ||||||||||||
(unaudited, in thousands) | ||||||||||||
As of | As of | |||||||||||
December 31, | December 31, | |||||||||||
2013 | 2012 | |||||||||||
ASSETS | ||||||||||||
Cash, cash equivalents and marketable securities | $ | 1,222,729 | $ | 1,705,710 | ||||||||
Accounts receivable, net | 824,406 | 686,848 | ||||||||||
Inventory | 659,003 | 447,373 | ||||||||||
Other current assets | 478,796 | 404,406 | ||||||||||
Total current assets | 3,184,934 | 3,244,337 | ||||||||||
Marketable securities | 625,772 | 2,036,658 | ||||||||||
Property, plant and equipment, net | 1,750,710 | 1,742,226 | ||||||||||
Intangible assets, net | 4,474,653 | 1,631,547 | ||||||||||
Goodwill | 1,232,916 | 1,201,296 | ||||||||||
Investments and other assets | 594,350 | 274,054 | ||||||||||
TOTAL ASSETS | $ | 11,863,335 | $ | 10,130,118 | ||||||||
LIABILITIES AND EQUITY | ||||||||||||
Current portion of notes payable and line of credit | $ | 3,494 | $ | 453,379 | ||||||||
Other current liabilities | 1,754,785 | 1,204,010 | ||||||||||
Notes payable and other financing arrangements | 592,433 | 687,396 | ||||||||||
Long-term deferred tax liability | 232,554 | 217,272 | ||||||||||
Other long-term liabilities | 659,231 | 604,266 | ||||||||||
Equity | 8,620,838 | 6,963,795 | ||||||||||
TOTAL LIABILITIES AND EQUITY | $ | 11,863,335 | $ | 10,130,118 | ||||||||
TABLE 3 | |||||||||||||||||||
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 | For the Twelve Months | ||||||||||||||||||
Ended December 31, | Ended December 31, | ||||||||||||||||||
EARNINGS PER SHARE | 2013 | 2012 | 2013 | 2012 | |||||||||||||||
GAAP earnings per share - Diluted | $ | 1.92 | $ | 1.23 | $ | 7.81 | $ | 5.76 | |||||||||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) | 0.42 | 0.17 | 1.15 | 0.77 | |||||||||||||||
Non-GAAP earnings per share - Diluted | $ | 2.34 | $ | 1.40 | $ | 8.96 | $ | 6.53 | |||||||||||
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. | $ | 457.3 | $ | 292.1 | $ | 1,862.3 | $ | 1,380.0 | |||||||||||
Adjustments: | |||||||||||||||||||
Amortization of acquired intangible assets | 105.5 | 49.1 | 330.7 | 194.3 | |||||||||||||||
(Gain) loss on fair value remeasurement of contingent consideration |
2.4 | 3.6 | (0.6 | ) | 27.2 | ||||||||||||||
SG&A: Stock option expense | 1.1 | 1.3 | 5.3 | 4.1 | |||||||||||||||
R&D: Stock option expense | 0.8 | 0.8 | 4.4 | 3.4 | |||||||||||||||
R&D: Restructuring and other | - | - | - | 8.6 | |||||||||||||||
Weston exit costs | 27.2 | - | 27.2 | - | |||||||||||||||
2010 Restructuring initiatives | - | - | - | 2.2 | |||||||||||||||
Income tax effect related to reconciling items | (37.3 | ) | (12.3 | ) | (93.0 | ) | (53.2 | ) | |||||||||||
Non-GAAP net income attributable to Biogen Idec Inc. | $ | 557.0 | $ | 334.6 | $ | 2,136.3 | $ | 1,566.6 | |||||||||||
2014 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: | |||||||||||||||||||
$ | Shares | Diluted EPS | |||||||||||||||||
Projected GAAP net income attributable to Biogen Idec Inc. | 2,338 | 238 | $ | 9.84 | |||||||||||||||
Adjustments: | |||||||||||||||||||
Stock option expense | 8 | ||||||||||||||||||
Amortization of acquired intangible assets | 402 | ||||||||||||||||||
(Gain) loss on fair value remeasurement of contingent consideration |
14 | ||||||||||||||||||
Income tax expense: Income tax effect related to reconciling items | (125 | ) | |||||||||||||||||
Projected Non-GAAP net income attributable to Biogen Idec Inc. | 2,637 | 238 | $ | 11.10 | |||||||||||||||
Numbers may not foot due to rounding. | |||||||||||||||||||
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 SEC rules. We believe that the disclosure of these non-GAAP financial measures provides additional insight into the ongoing economics of our business and reflects how we manage our business internally, set operational goals and forms the basis of our management incentive programs. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be viewed in isolation or as a substitute for reported, or GAAP, net income attributable to Biogen Idec Inc. and diluted earnings per share.
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 Biogen Idec Inc. and diluted earnings per share:
1. Purchase accounting and merger-related adjustments.
We exclude certain purchase accounting related items associated with the acquisition 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 fair value remeasurements 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. Weston Exit Costs.
As a result of our decision to relocate our headquarters to Cambridge, MA, we vacated a portion of our Weston, MA facility in the fourth quarter of 2013. This charge represents our remaining lease obligation for the vacated portion of our Weston facility, net of sublease income.
4. 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 Biogen Idec Inc.
TABLE 4 |
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Biogen Idec Inc. and Subsidiaries |
||||||||||
Product Revenues | ||||||||||
(unaudited, in thousands) | ||||||||||
For the Three Months | ||||||||||
Ended December 31, | ||||||||||
2013 | 2012 | |||||||||
PRODUCT REVENUES | ||||||||||
AVONEX® |
$ | 751,496 | $ | 753,212 | ||||||
TYSABRI® |
426,621 | 295,171 | ||||||||
TECFIDERA® |
397,612 | - | ||||||||
FAMPYRA® |
17,301 | 10,509 | ||||||||
FUMADERM ™ |
14,050 | 15,784 | ||||||||
Total product revenues, net | $ | 1,607,080 | $ | 1,074,676 |
For the Twelve Months | ||||||||||
Ended December 31, | ||||||||||
2013 | 2012 | |||||||||
PRODUCT REVENUES | ||||||||||
AVONEX® |
$ | 3,005,459 | $ | 2,913,105 | ||||||
TYSABRI® |
1,526,527 | 1,135,896 | ||||||||
TECFIDERA® |
876,112 | - | ||||||||
FAMPYRA® |
74,006 | 57,398 | ||||||||
FUMADERM ™ | 60,227 | 59,675 | ||||||||
Total product revenues, net | $ | 5,542,331 | $ | 4,166,074 | ||||||
Biogen Idec
Biogen Idec Media Contact:
Jason Glashow, 781-464-3260
Senior Director, Public Affairs
or
Biogen Idec Investor Contacts:
Claudine Prowse, Ph.D., 781-464-2442
Vice President, Investor Relations
or
Ben Strain, 781-464-2442
Senior Manager, Investor Relations