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 October 28, 2013. |
• | TECFIDERA revenues were $286 million during the third quarter, consisting of $284 million in U.S. sales and $2 million in sales in Canada. The Company estimates that approximately $12 million of U.S. TECFIDERA revenues in the third quarter represent incremental inventory in the channel. As a result, revenue generated in the U.S. from underlying patient demand was approximately $272 million in the third quarter. As of the end of the third quarter, we estimate U.S. inventory in the channel was in the 4 to 5 week range or approximately $92 million. TECFIDERA currently is approved in the United States, Canada and Australia. The Company continues to work to make TECFIDERA regulatory data protection clearer to all parties prior to approval from the European Medicines Agency (EMA). |
• | AVONEX third quarter revenues decreased slightly over the same period in the prior year to $733 million. The total was comprised of $457 million in U.S. sales and $277 million in sales outside the U.S. |
• | TYSABRI revenues, adjusted for the impact of hedging, increased 46% year-over-year to $401 million due to our recording 100 percent of TYSABRI revenues following our acquisition of full rights in TYSABRI from Elan in the second quarter of 2013. Global in-market sales of TYSABRI in the third quarter of 2013 totaled $403 million, remaining flat when compared to TYSABRI global in-market sales in the third quarter of 2012. The total in-market sales were comprised of $232 million in U.S. sales and $171 million in sales outside the U.S. |
• | RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $303 million for the quarter, an increase of 5% compared to the third quarter of 2012. |
• | Revenues for FAMPYRA® and FUMADERM™ totaled $33 million in the third quarter of 2013, compared to $28 million in the third quarter of 2012. |
• | Royalty revenues totaled $54 million in the third quarter of 2013, compared to $47 million in the third quarter of 2012. |
• | Corporate partner revenues totaled $17 million in the third quarter of 2013, compared to $12 million in the third quarter of 2012. |
• | As of September 30, 2013, Biogen Idec had cash, cash equivalents and marketable securities totaling approximately $1.0 billion. |
• | During the third quarter of 2013, Biogen Idec repurchased 1.7 million shares of stock at a total cost of approximately $360 million. |
• | Revenue growth is expected to be approximately 23% to 25%. |
• | Cost of Sales is expected to be approximately 12% to 14% of total revenue. |
• | R&D expense is expected to be approximately 21% 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 25% of pretax income. |
• | Non-GAAP diluted EPS is expected to be between $8.65 and $8.85. |
• | GAAP diluted EPS is expected to be between $7.50 and $7.70. |
• | Capital expenditures are expected to be in the range of $250 to $270 million. |
• | Interim analyses from the ENDORSE long-term extension study showing that TECFIDERA continues to offer consistent and strong efficacy combined with a favorable safety profile in a broad range of patients with relapsing-remitting multiple sclerosis in patients who had received TECFIDERA for up to six and a half years. |
• | New data on TYSABRI that reaffirmed the therapy’s efficacy in reducing multiple sclerosis disease activity. This effect was particularly significant in people with relapsing MS who initiated treatment when they had lower Expanded Disability Status Scale (EDSS) scores as well as in those who have been treated for more than two years. |
• | New clinical and MRI data from year one of the two-year, pivotal, Phase 3 ADVANCE study of PLEGRIDYTM (peginterferon beta-1a), which demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further supported the clinical efficacy profile of PLEGRIDY as a potential new treatment option for people with multiple sclerosis. |
• | On September 9, 2013, Biogen Idec announced a broad, multi-year collaboration with Isis Pharmaceuticals to leverage antisense technology to advance the treatment of neurological diseases. The agreement combines Biogen Idec's expertise in neurology with Isis' leadership in antisense technology to develop novel therapies to treat neurological disorders. Through this collaboration, Biogen Idec gains exclusive rights to the use of Isis’ antisense technology to develop therapies for a broad range of neurological targets. Targets discovered in this collaboration can be developed by Biogen Idec as biologic, small molecule, or antisense drugs. The agreement also provides Biogen Idec with the option to license ongoing antisense development programs against neurological targets. |
• | This month, Biogen Idec, along with other partners including the National Hemophilia Foundation (NHF), announced the national rollout of My Life, Our Future: Genotyping for Progress in Hemophilia, which offers genetic testing to people with hemophilia. Through genotyping, it is possible to identify the specific DNA mutation(s), or change(s), responsible for a person’s hemophilia and provide potentially useful information about bleeding severity or risk for inhibitors. The program will also work to create a central repository to enhance research to drive a better scientific understanding of the disorder. |
• | On September 24, 2013, Biogen Idec announced that it has been added to the prestigious Dow Jones Sustainability World Index (DJSI World) - becoming the first and only U.S. based biotech sector firm to make the list. The Company was also named to the Dow Jones Sustainability Index (DJSI) North America for the fourth consecutive year, one of only three biotech companies included. |
For the Three Months | For the Nine Months | ||||||||||||||
Ended September 30, | Ended September 30, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
Revenues: | |||||||||||||||
Product, net | $ | 1,453,554 | $ | 1,039,110 | $ | 3,935,251 | $ | 3,091,398 | |||||||
Unconsolidated joint business | 303,210 | 287,792 | 856,601 | 856,975 | |||||||||||
Royalty | 54,144 | 46,625 | 125,076 | 112,509 | |||||||||||
Corporate partner | 16,872 | 12,027 | 49,421 | 37,638 | |||||||||||
Total revenues | 1,827,780 | 1,385,554 | 4,966,349 | 4,098,520 | |||||||||||
Cost and expenses: | |||||||||||||||
Cost of sales, excluding amortization of acquired intangible assets | 234,696 | 139,358 | 599,173 | 411,666 | |||||||||||
Research and development | 410,017 | 304,217 | 1,021,820 | 989,738 | |||||||||||
Selling, general and administrative | 405,584 | 299,631 | 1,189,194 | 901,488 | |||||||||||
Amortization of acquired intangible assets | 99,998 | 53,013 | 233,524 | 151,256 | |||||||||||
Collaboration profit sharing | — | 75,545 | 85,357 | 239,951 | |||||||||||
(Gain) loss on fair value remeasurement of contingent consideration | (97 | ) | 9,456 | (2,983 | ) | 23,573 | |||||||||
Restructuring charges | — | 803 | — | 2,225 | |||||||||||
Total cost and expenses | 1,150,198 | 882,023 | 3,126,085 | 2,719,897 | |||||||||||
Gain on sale of rights | 6,949 | 31,719 | 17,319 | 31,719 | |||||||||||
Income from operations | 684,531 | 535,250 | 1,857,583 | 1,410,342 | |||||||||||
Other income (expense), net | (4,640 | ) | (4,548 | ) | (29,525 | ) | 13,546 | ||||||||
Income before income tax expense and equity in loss of investee, net of tax | 679,891 | 530,702 | 1,828,058 | 1,423,888 | |||||||||||
Income tax expense | 186,105 | 131,044 | 410,753 | 334,213 | |||||||||||
Equity in loss of investee, net of tax | 6,170 | 1,258 | 12,270 | 1,769 | |||||||||||
Net income | 487,616 | 398,400 | 1,405,035 | 1,087,906 | |||||||||||
Net income attributable to non-controlling interests, net of tax | — | — | — | — | |||||||||||
Net income attributable to Biogen Idec Inc. | $ | 487,616 | $ | 398,400 | $ | 1,405,035 | $ | 1,087,906 | |||||||
Net income per share: | |||||||||||||||
Basic earnings per share attributable to Biogen Idec Inc. | $ | 2.06 | $ | 1.68 | $ | 5.93 | $ | 4.56 | |||||||
Diluted earnings per share attributable to Biogen Idec Inc. | $ | 2.05 | $ | 1.67 | $ | 5.89 | $ | 4.53 | |||||||
Weighted-average shares used in calculating: | |||||||||||||||
Basic earnings per share attributable to Biogen Idec Inc. | 237,070 | 236,474 | 237,131 | 238,331 | |||||||||||
Diluted earnings per share attributable to Biogen Idec Inc. | 238,349 | 238,125 | 238,508 | 240,137 |
As of | As of | ||||||
September 30, | December 31, | ||||||
2013 | 2012 | ||||||
ASSETS | |||||||
Cash, cash equivalents and marketable securities | $ | 668,693 | $ | 1,705,710 | |||
Accounts receivable, net | 891,396 | 686,848 | |||||
Inventory | 614,483 | 447,373 | |||||
Other current assets | 469,100 | 404,406 | |||||
Total current assets | 2,643,672 | 3,244,337 | |||||
Marketable securities | 373,558 | 2,036,658 | |||||
Property, plant and equipment, net | 1,806,074 | 1,742,226 | |||||
Intangible assets, net | 4,580,199 | 1,631,547 | |||||
Goodwill | 1,210,718 | 1,201,296 | |||||
Investments and other assets | 636,028 | 274,054 | |||||
TOTAL ASSETS | $ | 11,250,249 | $ | 10,130,118 | |||
LIABILITIES AND EQUITY | |||||||
Current portion of notes payable and line of credit | $ | 3,385 | $ | 453,379 | |||
Other current liabilities | 1,515,326 | 1,204,010 | |||||
Notes payable and other financing arrangements | 694,894 | 687,396 | |||||
Long-term deferred tax liability | 302,483 | 217,272 | |||||
Other long-term liabilities | 608,473 | 604,266 | |||||
Equity | 8,125,688 | 6,963,795 | |||||
TOTAL LIABILITIES AND EQUITY | $ | 11,250,249 | $ | 10,130,118 |
For the Three Months | For the Nine Months | ||||||||||||||
Ended September 30, | Ended September 30, | ||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||
EARNINGS PER SHARE | |||||||||||||||
GAAP earnings per share - Diluted | $ | 2.05 | $ | 1.67 | $ | 5.89 | $ | 4.53 | |||||||
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) | 0.31 | 0.24 | 0.73 | 0.60 | |||||||||||
Non-GAAP earnings per share - Diluted | $ | 2.35 | $ | 1.91 | $ | 6.62 | $ | 5.13 | |||||||
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. | $ | 487.6 | $ | 398.4 | $ | 1,405.0 | $ | 1,087.9 | |||||||
Adjustments: | |||||||||||||||
Amortization of acquired intangible assets | 97.1 | 50.9 | 225.2 | 145.2 | |||||||||||
(Gain) loss on fair value remeasurement of contingent consideration | (0.1 | ) | 9.5 | (3.0 | ) | 23.6 | |||||||||
SG&A: Stock option expense | 1.3 | 1.4 | 4.2 | 2.8 | |||||||||||
R&D: Stock option expense | 1.2 | 1.0 | 3.6 | 2.6 | |||||||||||
R&D: Restructuring and other | — | 7.5 | — | 8.6 | |||||||||||
2010 Restructuring initiatives | — | 0.8 | — | 2.2 | |||||||||||
Income tax effect related to reconciling items | (26.0 | ) | (14.8 | ) | (55.7 | ) | (40.9 | ) | |||||||
Non-GAAP net income attributable to Biogen Idec Inc. | $ | 561.1 | $ | 454.7 | $ | 1,579.3 | $ | 1,232.0 |
$ | Shares | Diluted EPS | ||||||||
Projected GAAP net income attributable to Biogen Idec Inc. | $ | 1,810 | 238 | $ | 7.60 | |||||
Adjustments: | ||||||||||
Stock option expense | 9 | |||||||||
Loss on exit of Weston facility | 25 | |||||||||
Amortization of acquired intangible assets | 330 | |||||||||
(Gain) loss on fair value remeasurement of contingent consideration | 1 | |||||||||
Income tax expense: Income tax effect related to reconciling items | (90 | ) | ||||||||
Projected Non-GAAP net income attributable to Biogen Idec Inc. | $ | 2,085 | 238 | $ | 8.75 |
For the Three Months | |||||||
Ended September 30, | |||||||
2013 | 2012 | ||||||
PRODUCT REVENUES | |||||||
AVONEX® | $ | 733,449 | $ | 736,208 | |||
TYSABRI® | 400,995 | 274,769 | |||||
TECFIDERA® | 286,366 | — | |||||
FAMPYRA® | 16,691 | 12,168 | |||||
FUMADERMTM | 16,053 | 15,965 | |||||
Total product revenues | $ | 1,453,554 | $ | 1,039,110 |
For the Nine Months | |||||||
Ended September 30, | |||||||
2013 | 2012 | ||||||
PRODUCT REVENUES | |||||||
AVONEX® | $ | 2,253,963 | $ | 2,159,893 | |||
TYSABRI® | 1,099,906 | 840,725 | |||||
TECFIDERA® | 478,500 | — | |||||
FAMPYRA® | 56,705 | 46,889 | |||||
FUMADERMTM | 46,177 | 43,891 | |||||
Total product revenues | $ | 3,935,251 | $ | 3,091,398 |