Delaware | 0-19311 | 33-0112644 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
Exhibit Number | Description |
99 | Biogen's press release dated July 24, 2015. |
• | Total multiple sclerosis product sales were $2.1 billion compared to $2.0 billion in the same quarter last year. |
• | TECFIDERA revenues were $883 million compared to $700 million in the same quarter last year. These results consisted of $721 million in U.S. sales and $163 million in sales outside the U.S. compared to $585 million and $115 million, respectively, in the second quarter of 2014. |
◦ | TECFIDERA revenues in the second quarter of 2015 increased 7% from $825 million in the first quarter of 2015. In the U.S., TECFIDERA revenues increased 11%, which was partially offset by an 8% decrease outside the U.S. The decrease outside the U.S. was primarily due to lower pricing in Germany, as unit volume increased 14%. |
• | Interferon revenues, including AVONEX® and PLEGRIDY, were $690 million compared to $774 million in the same quarter last year. These results consisted of $455 million in U.S. sales and $235 million in sales outside the U.S. compared to $498 million and $276 million, respectively, in the second quarter of 2014. |
◦ | Interferon revenues in the second quarter of 2015 decreased 9% from $755 million in the first quarter of 2015. Interferon revenues decreased 12% in the U.S. and 1% outside the U.S. versus the first quarter of 2015. The Company believes the majority of the U.S. decrease is due to an inventory reduction in the wholesale channel. |
• | TYSABRI revenues were $463 million compared to $533 million in the same quarter last year. These results consisted of $269 million in U.S. sales and $195 million in sales outside the U.S. compared to $250 million and $284 million, respectively, in the second quarter of 2014. TYSABRI revenues outside the U.S. decreased 31% versus the second quarter of 2014, due primarily to the recognition of $54 million of previously deferred revenues in Italy in the second quarter of 2014 following a pricing agreement with AIFA. |
• | Net revenues relating to RITUXAN® and GAZYVA® from our unconsolidated joint business arrangement were $338 million compared to $303 million in the same quarter last year. |
• | ELOCTATE® revenues were $74 million and ALPROLIX® revenues were $54 million. |
• | Revenues for FAMPYRA® and FUMADERM™ were $34 million compared to $38 million in the same quarter last year. |
• | Royalty revenues were $9 million compared to $40 million in the same quarter last year. The decrease is primarily due to the cessation of ANGIOMAX® royalty payments following the expiration of applicable U.S. patent rights in December 2014. |
• | Corporate partner revenues were $47 million compared to $22 million in the same quarter last year. |
• | Foreign exchange, offset by hedging, weakened total revenues by approximately $79 million compared to the second quarter of 2014. |
• | Non-GAAP SG&A expense was $492 million compared to $540 million in the same quarter last year. GAAP SG&A expense was $492 million compared to $577 million in the same quarter last year. |
• | Non-GAAP R&D expense was $491 million compared to $446 million in the same quarter last year. GAAP R&D expense was $491 million compared to $447 million in the same quarter last year. |
• | As of June 30, 2015, Biogen had cash, cash equivalents and marketable securities totaling approximately $4.5 billion. |
• | In May 2015, Biogen announced that its Board of Directors authorized a program to repurchase up to $5 billion of the Company’s common stock. Biogen currently expects that purchases will be executed within a period of up to five years. |
• | Revenue growth is expected to be approximately 6% to 8% compared to 2014, a decrease from prior guidance based largely on revised expectations for the growth of TECFIDERA. |
• | R&D expense is expected to be approximately 19% to 20% of total revenue, unchanged from prior guidance. |
• | SG&A expense is expected to be approximately 20% to 21% of total revenue, unchanged from prior guidance. |
• | GAAP diluted EPS is expected to be between $14.25 and $14.70, a decrease from prior guidance. |
• | Non-GAAP diluted EPS is expected to be between $15.50 and $15.95, a decrease from prior guidance. |
• | In April 2015, the U.S. Food and Drug Administration accepted for review the Biologics License Application for ZINBRYTA™ for the treatment of relapsing forms of multiple sclerosis. ZINBRYTA is being jointly developed by Biogen and AbbVie. |
• | In June 2015, Biogen’s collaboration partner Isis Pharmaceuticals announced additional data from two Phase 2 studies of ISIS-SMNRx for the treatment of spinal muscular atrophy in infants and children. Available data to date continues to support further development, and two Phase 3 studies are active and currently enrolling patients. |
• | In July 2015, Biogen and Applied Genetic Technologies Corporation (AGTC) announced a broad collaboration and license agreement to develop gene therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. |
• | In July 2015, Biogen presented new data from the Phase 1b PRIME study of aducanumab at the Alzheimer’s Association International Conference®. Consistent with previously reported results, the one-year data from the 6 mg/kg arm demonstrated a statistically significant reduction of beta amyloid in the brain. In exploratory analyses, the 6 mg/kg dose showed an improvement in the slowing of clinical decline, as measured by the Mini Mental State Examination (MMSE) and Clinical Dementia Rating sum of boxes (CDR-SB) scales, which was not statistically significant. In a pre-specified analysis across placebo and all doses of aducanumab, the slowing of clinical decline was shown to be dose-dependent, and this dose-dependence achieved statistical |
• | Biogen recently initiated clinical sites for two global Phase 3 studies, EMERGE and ENGAGE, for aducanumab in Alzheimer’s disease. EMERGE and ENGAGE are each planned to enroll 1,350 patients with early Alzheimer’s disease. |
• | Plans are underway to continue the development of TYSABRI (natalizumab) for acute ischemic stroke following the Company’s Phase 2 study. While the Phase 2 results did not demonstrate an impact on change in infarct volume, the primary endpoint, secondary and exploratory clinical endpoints suggest that TYSABRI did have a beneficial impact on patient functional deficits. |
• | Biogen has ceased development of Neublastin in moderate to severe sciatica after Phase 2 study results failed to meet the Company’s targeted product profile. |
• | In June 2015, Biogen presented 23 Company-sponsored platform and poster presentations at the International Society on Thrombosis and Haemostasis 2015 Congress. The data presented included full results from the Kids B-LONG study of ALPROLIX in children with hemophilia B as well as interim results on the long-term safety and efficacy of ELOCTATE in hemophilia A from the ASPIRE extension study. |
• | In June 2015, Biogen and Swedish Orphan Biovitrum AB (Sobi) announced that the European Medicines Agency accepted the Marketing Authorization Application of ALPROLIX for the treatment of hemophilia B. In July 2015, Sobi exercised its opt-in right to assume final development and commercialization responsibilities for ALPROLIX for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. |
• | In June 2015, Biogen and Samsung Bioepis Co., Ltd presented results from their anti-TNF biosimilar portfolio at the European League Against Rheumatism Annual Congress (EULAR 2015). |
• | In June 2015, Biogen announced that it has achieved carbon neutrality, a milestone reached through a multi-year initiative to reduce its own emissions and by investing in environmental projects to offset the remaining carbon associated with its business. |
• | In June 2015, Biogen announced that it intends to build a new, next generation manufacturing facility in Solothurn, Switzerland to support its emerging pipeline. Biogen also recently entered into a definitive agreement with Eisai Co., Ltd. to transfer ownership of Eisai’s Research Triangle Park manufacturing campus to Biogen. |
• | In July 2015, Biogen announced that Douglas Williams, Ph.D., Executive Vice President of Research & Development, will leave the Company at the end of July to become chief executive officer of a start-up biotechnology company. |
For the Three Months | For the Six Months | ||||||||||||||
Ended June 30, | Ended June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Revenues: | |||||||||||||||
Product, net | $ | 2,198,566 | $ | 2,056,292 | $ | 4,370,888 | $ | 3,799,057 | |||||||
Unconsolidated joint business | 337,510 | 303,296 | 668,121 | 600,181 | |||||||||||
Royalty | 8,583 | 40,344 | 28,397 | 78,200 | |||||||||||
Corporate partner | 46,983 | 21,520 | 79,199 | 73,765 | |||||||||||
Total revenues | 2,591,642 | 2,421,452 | 5,146,605 | 4,551,203 | |||||||||||
Cost and expenses: | |||||||||||||||
Cost of sales, excluding amortization of acquired intangible assets | 286,120 | 291,887 | 598,551 | 571,132 | |||||||||||
Research and development | 490,728 | 447,273 | 951,277 | 976,157 | |||||||||||
Selling, general and administrative | 491,895 | 576,622 | 1,052,256 | 1,088,296 | |||||||||||
Amortization of acquired intangible assets | 92,004 | 116,826 | 187,907 | 260,084 | |||||||||||
(Gain) loss on fair value remeasurement of contingent consideration | (2,201 | ) | 4,019 | 5,643 | 3,220 | ||||||||||
Total cost and expenses | 1,358,546 | 1,436,627 | 2,795,634 | 2,898,889 | |||||||||||
Gain on sale of rights | — | 3,900 | — | 7,759 | |||||||||||
Income from operations | 1,233,096 | 988,725 | 2,350,971 | 1,660,073 | |||||||||||
Other income (expense), net | (10,889 | ) | 4,861 | (25,875 | ) | (740 | ) | ||||||||
Income before income tax expense and equity in loss of investee, net of tax | 1,222,207 | 993,586 | 2,325,096 | 1,659,333 | |||||||||||
Income tax expense | 292,501 | 268,521 | 574,382 | 446,935 | |||||||||||
Equity in loss of investee, net of tax | 4,881 | 1,933 | 5,715 | 9,538 | |||||||||||
Net income | 924,825 | 723,132 | 1,744,999 | 1,202,860 | |||||||||||
Net income (loss) attributable to noncontrolling interests, net of tax | (2,451 | ) | 8,626 | (4,818 | ) | 8,398 | |||||||||
Net income attributable to Biogen Inc. | $ | 927,276 | $ | 714,506 | $ | 1,749,817 | $ | 1,194,462 | |||||||
Net income per share: | |||||||||||||||
Basic earnings per share attributable to Biogen Inc. | $ | 3.94 | $ | 3.02 | $ | 7.44 | $ | 5.05 | |||||||
Diluted earnings per share attributable to Biogen Inc. | $ | 3.93 | $ | 3.01 | $ | 7.42 | $ | 5.03 | |||||||
Weighted-average shares used in calculating: | |||||||||||||||
Basic earnings per share attributable to Biogen Inc. | 235,286 | 236,661 | 235,122 | 236,729 | |||||||||||
Diluted earnings per share attributable to Biogen Inc. | 235,718 | 237,401 | 235,671 | 237,634 |
As of | As of | ||||||
June 30, 2015 | December 31, 2014 | ||||||
ASSETS | |||||||
Cash, cash equivalents and marketable securities | $ | 2,368,673 | $ | 1,845,384 | |||
Accounts receivable, net | 1,310,821 | 1,292,445 | |||||
Inventory | 865,738 | 804,022 | |||||
Other current assets | 1,073,753 | 730,822 | |||||
Total current assets | 5,618,985 | 4,672,673 | |||||
Marketable securities | 2,101,796 | 1,470,652 | |||||
Property, plant and equipment, net | 1,837,670 | 1,765,683 | |||||
Intangible assets, net | 4,294,791 | 4,028,507 | |||||
Goodwill | 2,154,341 | 1,760,249 | |||||
Investments and other assets | 751,588 | 618,795 | |||||
TOTAL ASSETS | $ | 16,759,171 | $ | 14,316,559 | |||
LIABILITIES AND EQUITY | |||||||
Current portion of notes payable | $ | 3,262 | $ | 3,136 | |||
Other current liabilities | 2,552,570 | 2,216,570 | |||||
Notes payable | 576,207 | 582,061 | |||||
Long-term deferred tax liability | 138,403 | 50,656 | |||||
Other long-term liabilities | 915,731 | 650,096 | |||||
Equity | 12,572,998 | 10,814,040 | |||||
TOTAL LIABILITIES AND EQUITY | $ | 16,759,171 | $ | 14,316,559 |
For the Three Months | For the Six Months | ||||||||||||||
Ended June 30, | Ended June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
GAAP earnings per share - Diluted | $ | 3.93 | $ | 3.01 | $ | 7.42 | $ | 5.03 | |||||||
Adjustments to GAAP net income attributable to Biogen Inc. (as detailed below) | 0.29 | 0.48 | 0.62 | 0.93 | |||||||||||
Non-GAAP earnings per share - Diluted | $ | 4.22 | $ | 3.49 | $ | 8.04 | $ | 5.96 | |||||||
An itemized reconciliation between net income attributable to Biogen Inc. on a GAAP basis and on a non-GAAP basis is as follows: | |||||||||||||||
For the Three Months | For the Six Months | ||||||||||||||
Ended June 30, | Ended June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
GAAP net income attributable to Biogen Inc. | $ | 927.3 | $ | 714.5 | $ | 1,749.8 | $ | 1,194.5 | |||||||
Adjustments: | |||||||||||||||
Amortization of acquired intangible assets | 86.8 | 113.0 | 179.3 | 252.8 | |||||||||||
(Gain) loss on fair value remeasurement of contingent consideration | (2.2 | ) | 4.0 | 5.6 | 3.2 | ||||||||||
SG&A: Stock option expense | — | 1.5 | — | 4.0 | |||||||||||
R&D: Stock option expense | — | 1.2 | — | 3.5 | |||||||||||
Donation to Biogen Foundation | — | 35.0 | — | 35.0 | |||||||||||
Income tax effect related to reconciling items | (17.1 | ) | (40.1 | ) | (39.7 | ) | (77.1 | ) | |||||||
Non-GAAP net income attributable to Biogen Inc. | $ | 994.8 | $ | 829.1 | $ | 1,895.0 | $ | 1,415.9 | |||||||
2015 Full Year Guidance: GAAP to Non-GAAP Reconciliation | |||||||||||||||
An itemized reconciliation between projected net income attributable to Biogen Inc. and diluted earnings per share on a GAAP basis and on a non-GAAP basis is as follows: | |||||||||||||||
$ | Shares | Diluted EPS | |||||||||||||
Projected GAAP net income attributable to Biogen Inc. | $ | 3,411.6 | 235.7 | $ | 14.48 | ||||||||||
Adjustments: | |||||||||||||||
Amortization of acquired intangible assets | 358.8 | ||||||||||||||
(Gain) loss on fair value remeasurement of contingent consideration | 15.8 | ||||||||||||||
Income tax effect related to reconciling items | (80.5 | ) | |||||||||||||
Projected Non-GAAP net income attributable to Biogen Inc. | $ | 3,705.7 | 235.7 | $ | 15.73 |
For the Three Months | For the Six Months | ||||||||||||||
Ended June 30, | Ended June 30, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
PRODUCT REVENUES | |||||||||||||||
Multiple Sclerosis (MS): | |||||||||||||||
TECFIDERA | $ | 883.3 | $ | 700.4 | $ | 1,708.2 | $ | 1,206.1 | |||||||
AVONEX | 615.2 | 773.8 | 1,307.9 | 1,535.3 | |||||||||||
PLEGRIDY | 74.5 | — | 136.3 | — | |||||||||||
TYSABRI | 463.1 | 533.4 | 925.7 | 974.4 | |||||||||||
FAMPYRA | 21.1 | 22.3 | 41.1 | 41.3 | |||||||||||
Hemophilia: | |||||||||||||||
ALPROLIX | 54.4 | 10.4 | 97.5 | 10.4 | |||||||||||
ELOCTATE | 74.3 | — | 127.9 | — | |||||||||||
Other product revenues: | |||||||||||||||
FUMADERM | 12.7 | 16.0 | 26.3 | 31.6 | |||||||||||
Total product revenues, net | $ | 2,198.6 | $ | 2,056.3 | $ | 4,370.9 | $ | 3,799.1 |