Delaware | 0-19311 | 33-0112644 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
Exhibit Number | Description |
99 | Biogen Idec's press release dated January 28, 2013. |
Biogen Idec Media Contact: | Biogen Idec Investor Contacts: |
Banks Willis | Ben Strain |
Senior Manager, Public Affairs | Senior Manager, Investor Relations |
Biogen Idec | Biogen Idec |
Tel: (781) 464-3260 | Tel: (781) 464-2442 |
Claudine Prowse, Ph.D. | |
Vice President, Investor Relations | |
Biogen Idec | |
Tel: (781) 464-2442 |
• | Total revenues in 2012 increased 9% to $5.5 billion year-over-year. |
• | On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full year 2012 GAAP diluted EPS were $5.76, an increase of 14% versus 2011. GAAP net income attributable to Biogen Idec for the year was $1.4 billion, an increase of 12% versus 2011. |
• | Non-GAAP diluted EPS for 2012 were $6.53, an increase of 11% over 2011. Non-GAAP net income attributable to Biogen Idec for 2012 was $1.6 billion, an increase of 8% versus 2011. |
• | TYSABRI® (natalizumab) revenues increased 5% year-over-year to $1.1 billion while AVONEX® (interferon beta-1a) revenues increased 8% year-over-year to $2.9 billion. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $1.1 billion for the year, an increase of 14% versus prior year. |
• | Global in-market sales of TYSABRI for the full year of 2012 were $1.6 billion, an increase of 8% over 2011. The total was comprised of $886 million in U.S. sales and $745 million in sales outside the U.S. |
• | Based upon data available to us through the TOUCH® prescribing program and other third-party sources, as of the end of December 2012, the Company estimates that approximately 72,700 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 112,200 patients have ever been treated with TYSABRI in the post-marketing setting. |
• | For the full year, revenues from other products were $117 million, an increase of 67% versus 2011. |
• | Table 4 provides individual product revenues. |
• | Royalties in 2012 increased 6% to $169 million, versus 2011. |
• | Corporate partner revenues for the full year of 2012 were $44 million, compared to $57 million in 2011. |
• | Fourth quarter revenues increased 7% to $1.4 billion, compared to the fourth quarter of 2011. TYSABRI revenues increased 10% year-over-year to $295 million while AVONEX revenues increased 7% year-over-year to $753 million. RITUXAN revenues from our unconsolidated joint business arrangement were $281 million for the quarter, an increase of 9% over the prior year. |
• | Global in-market sales of TYSABRI in the fourth quarter of 2012 were $433 million, an increase of 14% over the fourth quarter of 2011. The total was comprised of $243 million in U.S. sales and $190 million in sales outside the U.S. |
• | Revenues from other products in the fourth quarter of 2012 were $26 million, compared to $24 million in the fourth quarter of 2011. |
• | Royalties were $56 million in the fourth quarter of 2012, an increase of 7% compared to the fourth quarter of 2011. |
• | For the fourth quarter of 2012, corporate partner revenues were $6 million, compared to $20 million in 2011. |
• | During the quarter, we corrected our accounting for taxes on capitalized interest at our Denmark facility. The error accumulated over several prior years and increased tax expense in the quarter by $29 million. GAAP and non-GAAP net income attributable to Biogen Idec and diluted EPS include the impact of our correction. This unfavorably impacted both GAAP and non-GAAP fourth quarter 2012 diluted EPS by 12 cents. |
• | Fourth quarter 2012 GAAP diluted EPS were $1.23, an increase of 1% over the fourth quarter of 2011. GAAP net income attributable to Biogen Idec for the quarter was $292 million, a decrease of 3% from the fourth quarter of 2011. |
• | Non-GAAP diluted EPS for the fourth quarter of 2012 were $1.40, a decrease of 7% over the fourth quarter of 2011. Non-GAAP net income attributable to Biogen Idec for the fourth quarter of 2012 was $335 million, a decrease of 10% from the fourth quarter of 2011. Table 3 includes a reconciliation of our GAAP to non-GAAP results. |
• | Revenue growth is expected to be approximately 10%. |
• | Cost of Sales is expected to be approximately 8% to 10% of total revenue. |
• | R&D expense is expected to be approximately 22% to 23% of total revenue. |
• | SG&A expense is expected to be approximately 24% to 26% of total revenue. |
• | Tax expense is expected to be approximately 24% to 26% of pretax income. |
• | Non-GAAP diluted EPS is expected to be between $7.15 and $7.25. |
• | GAAP diluted EPS is expected to be between $6.45 and $6.55. |
• | Capital expenditures are expected to be in the range of $250 to $270 million. |
• | On December 20, 2012, Biogen Idec announced it created a new research consortium in collaboration with several leading academic research centers that will leverage a range of scientific techniques and disciplines to identify new approaches to treating ALS. It is anticipated that coordinating research and sharing results across a number of different disciplines will greatly accelerate the understanding of the mechanism of ALS and the development of new targets and approaches to treatment. |
• | On December 12, 2012, Biogen Idec and Eisai Inc. announced a strategic alliance aimed at bolstering the manufacturing capabilities of both companies' Research Triangle Park (RTP)-based facilities. Under the terms of the agreement, Biogen Idec will lease a portion of the Eisai facility to manufacture oral solid dose products for both companies. Eisai will provide Biogen Idec with vial-filling services for biologic therapies and packaging services for oral solid dose products. The 10-year lease agreement, which is cancellable after five years and will become effective in February 2013, gives Biogen Idec the option to purchase the Eisai oral solid dose facility. |
• | On December 10, 2012, Biogen Idec and Isis Pharmaceuticals, Inc. announced they have entered into a global collaboration agreement under which the companies will discover and develop antisense drugs against three targets to treat neurological or neuromuscular disorders. Biogen Idec and Isis are also developing antisense drugs to treat spinal muscular atrophy and myotonic dystrophy type 1 under previously established collaborations. |
• | On November 29, 2012, Biogen Idec dedicated a new facility in RTP, consolidating its 300-person Patient Services operation within its RTP campus. The new 190,000 square foot building is anticipated to achieve LEED-Gold certified status in the coming months and will accommodate increasing levels of manufacturing activity at the site. The official groundbreaking for the building was in April 2011. |
• | On November 8, 2012, Biogen Idec, together with a coalition of leaders in hemophilia advocacy and treatment, announced a nationwide program that will offer free genetic testing to people with hemophilia and their families. The initiative, called My Life, Our Future: Genotyping for Progress in Hemophilia, is a partnership between the National Hemophilia Foundation, the American Thrombosis and Hemostasis Network, Puget Sound Blood Center and Biogen Idec. Designed to help uncover genetic information that can be used by physicians to individualize the care of people with hemophilia, the initiative will also work to generate data that may lead to new scientific discoveries. |
For the Three Months Ended December 31, | For the Twelve Months Ended December 31, | ||||||||||||||
2012 | 2011 | 2012 | 2011 | ||||||||||||
Revenues: | |||||||||||||||
Product, net | $ | 1,074,676 | $ | 996,555 | $ | 4,166,074 | $ | 3,836,117 | |||||||
Unconsolidated joint business | 280,948 | 257,543 | 1,137,923 | 996,597 | |||||||||||
Royalty | 56,170 | 52,686 | 168,679 | 158,497 | |||||||||||
Corporate partner | 6,147 | 19,926 | 43,785 | 57,423 | |||||||||||
Total revenues | 1,417,941 | 1,326,710 | 5,516,461 | 5,048,634 | |||||||||||
Cost and expenses: | |||||||||||||||
Cost of sales, excluding amortization of acquired intangible assets | 133,828 | 139,638 | 545,494 | 466,780 | |||||||||||
Research and development | 345,180 | 338,933 | 1,334,919 | 1,219,602 | |||||||||||
Selling, general and administrative | 375,977 | 283,916 | 1,277,465 | 1,056,133 | |||||||||||
Collaboration profit sharing | 77,944 | 73,453 | 317,895 | 317,771 | |||||||||||
Amortization of acquired intangible assets | 50,948 | 50,866 | 202,204 | 208,566 | |||||||||||
Fair value adjustment of contingent consideration | 3,630 | 30,165 | 27,202 | 36,065 | |||||||||||
Restructuring charge | - | 636 | 2,225 | 19,026 | |||||||||||
Total cost and expenses | 987,507 | 917,607 | 3,707,404 | 3,323,943 | |||||||||||
Gain on sale of rights | 15,073 | - | 46,792 | - | |||||||||||
Income from operations | 445,507 | 409,103 | 1,855,849 | 1,724,691 | |||||||||||
Other income (expense), net | (14,290 | ) | (3,973 | ) | (744 | ) | (13,477 | ) | |||||||
Income before income tax expense and equity in loss of investee, net of tax | 431,217 | 405,130 | 1,855,105 | 1,711,214 | |||||||||||
Income tax expense | 136,341 | 104,919 | 470,554 | 444,528 | |||||||||||
Equity in loss of investee, net of tax | 2,749 | - | 4,518 | - | |||||||||||
Net income | 292,127 | 300,211 | 1,380,033 | 1,266,686 | |||||||||||
Net income attributable to non-controlling interests, net of tax | - | (27 | ) | - | 32,258 | ||||||||||
Net income attributable to Biogen Idec Inc. | $ | 292,127 | $ | 300,238 | $ | 1,380,033 | $ | 1,234,428 | |||||||
Net income per share: | |||||||||||||||
Basic earnings per share attributable to Biogen Idec Inc. | $ | 1.23 | $ | 1.24 | $ | 5.80 | $ | 5.09 | |||||||
Diluted earnings per share attributable to Biogen Idec Inc. | $ | 1.23 | $ | 1.22 | $ | 5.76 | $ | 5.04 | |||||||
Weighted-average shares used in calculating: | |||||||||||||||
Basic earnings per share attributable to Biogen Idec Inc. | 236,612 | 242,959 | 237,938 | 242,395 | |||||||||||
Diluted earnings per share attributable to Biogen Idec Inc. | 238,324 | 245,382 | 239,740 | 245,033 |
As of December 31, 2012 | As of December 31, 2011 | ||||||
ASSETS | |||||||
Cash, cash equivalents and marketable securities | $ | 1,705,710 | $ | 1,690,657 | |||
Accounts receivable, net | 686,848 | 584,603 | |||||
Inventory | 447,373 | 326,843 | |||||
Other current assets | 404,406 | 373,324 | |||||
Total current assets | 3,244,337 | 2,975,427 | |||||
Marketable securities | 2,036,658 | 1,416,737 | |||||
Property, plant and equipment, net | 1,742,226 | 1,571,387 | |||||
Intangible assets, net | 1,631,547 | 1,608,191 | |||||
Goodwill | 1,201,296 | 1,146,314 | |||||
Investments and other assets | 274,054 | 331,548 | |||||
TOTAL ASSETS | $ | 10,130,118 | $ | 9,049,604 | |||
LIABILITIES AND EQUITY | |||||||
Current portion of notes payable and line of credit | $ | 453,379 | $ | 3,292 | |||
Other current liabilities | 1,204,010 | 909,597 | |||||
Long-term deferred tax liability | 217,272 | 248,644 | |||||
Notes payable, line of credit and other financing arrangements | 687,396 | 1,060,808 | |||||
Other long-term liabilities | 604,266 | 400,276 | |||||
Equity | 6,963,795 | 6,426,987 | |||||
TOTAL LIABILITIES AND EQUITY | $ | 10,130,118 | $ | 9,049,604 |
For the Three Months Ended December 31, | For the Twelve Months Ended December 31, | ||||||||||||||
2012 | 2011 | 2012 | 2011 | ||||||||||||
EARNINGS PER SHARE | |||||||||||||||
GAAP earnings per share - Diluted | $ | 1.23 | $ | 1.22 | $ | 5.76 | $ | 5.04 | |||||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) | 0.17 | 0.29 | 0.77 | 0.86 | |||||||||||
Non-GAAP earnings per share - Diluted | $ | 1.40 | $ | 1.51 | $ | 6.53 | $ | 5.90 | |||||||
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. | $ | 292.1 | $ | 300.2 | $ | 1,380.0 | $ | 1,234.4 | |||||||
Adjustments: | |||||||||||||||
R&D: Restructuring and other | - | - | 8.6 | - | |||||||||||
R&D: Stock option expense | 0.8 | 1.3 | 3.4 | 4.8 | |||||||||||
SG&A: Stock option expense | 1.3 | 2.0 | 4.1 | 7.5 | |||||||||||
Amortization of acquired intangible assets | 49.1 | 49.5 | 194.3 | 206.4 | |||||||||||
2010 Restructuring initiatives | - | 0.6 | 2.2 | 19.0 | |||||||||||
Fair value adjustment of contingent consideration | 3.6 | 30.2 | 27.2 | 36.1 | |||||||||||
Income tax effect related to reconciling items | (12.3) | (13.6) | (53.2) | (62.0) | |||||||||||
Non-GAAP net income attributable to Biogen Idec Inc. | $ | 334.6 | $ | 370.2 | $ | 1,566.6 | $ | 1,446.2 |
$ | Shares | Diluted EPS* | ||||||||
Projected GAAP net income attributable to Biogen Idec Inc. | $ | 1,550 | 238 | $ | 6.51 | |||||
Adjustments: | ||||||||||
Stock option expense | 8 | |||||||||
Restructuring and other | - | |||||||||
Amortization of acquired intangible assets | 194 | |||||||||
Fair value adjustment of contingent consideration | 16 | |||||||||
Income tax expense: Income tax effect related to reconciling items | (54 | ) | ||||||||
Projected Non-GAAP net income attributable to Biogen Idec Inc. | $ | 1,714 | 238 | $ | 7.20 |
For the Three Months Ended December 31, | |||||||
2012 | 2011 | ||||||
PRODUCT REVENUES | |||||||
AVONEX® | $ | 753,212 | $ | 703,226 | |||
TYSABRI® | 295,171 | 269,350 | |||||
FAMPYRA® | 10,509 | 10,433 | |||||
FUMADERM | 15,784 | 13,546 | |||||
Other | - | - | |||||
Total product revenues | $ | 1,074,676 | $ | 996,555 |
For the Twelve Months Ended December 31, | |||||||
2012 | 2011 | ||||||
PRODUCT REVENUES | |||||||
AVONEX® | $ | 2,913,105 | $ | 2,686,624 | |||
TYSABRI® | 1,135,896 | 1,079,448 | |||||
FAMPYRA® | 57,398 | 13,569 | |||||
FUMADERM | 59,675 | 54,728 | |||||
Other | - | 1,748 | |||||
Total product revenues | $ | 4,166,074 | $ | 3,836,117 |