On September 26, 2016 Biogen Inc. (NASDAQ: BIIB) reported third quarter 2016 financial results, including:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Total revenues of $3.0 billion, a 6% increase versus the same quarter in the prior year (Press release, Biogen, OCT 26, 2016, View Source [SID1234516018]).
Growth was driven by a 10% increase in worldwide TECFIDERA revenues as well as increased revenues from TYSABRI,
ELOCTATE, ALPROLIX, and BENEPALI. Revenues were partially offset by a decrease in worldwide interferon sales.
In the U.S., Biogen estimates that TECFIDERA benefited by approximately $40 million to $50 million versus prior quarter due to inventory build in the channel. Outside the U.S., third quarter 2016 TECFIDERA revenue decreased versus second quarter primarily due to parallel trade dynamics.
Foreign exchange negatively impacted total revenues by approximately $54 million compared with the third quarter of 2015, driven by changes in hedge results.
GAAP net income attributable to Biogen Inc. of $1.0 billion, a 7% increase versus the same quarter in the prior year.
GAAP diluted earnings per share (EPS) of $4.71, a 13% increase versus the same quarter in the prior year.
Non-GAAP net income attributable to Biogen Inc. of $1.1 billion, a 9% increase versus the same quarter in the prior year.
Non-GAAP diluted EPS of $5.19, a 16% increase versus the same quarter in the prior year.
(In millions, except per share amounts) Q3 ‘16 Q2 ‘16 Q3 ‘15 Q3 ‘16 v. Q2 ‘16 Q3 ‘16 v. Q3 ‘15
Total revenues $ 2,956 $ 2,894 $ 2,778 2 % 6 %
GAAP net income* $ 1,033 $ 1,050 $ 966 (2 %) 7 %
GAAP diluted EPS $ 4.71 $ 4.79 $ 4.15 (2 %) 13 %
Non-GAAP net income* $ 1,138 $ 1,142 $ 1,042 (0 %) 9 %
Non-GAAP diluted EPS $ 5.19 $ 5.21 $ 4.48 (0 %) 16 %
*Net income attributable to Biogen Inc.
A reconciliation of GAAP to Non-GAAP quarterly financial results can be found in Table 3 at the end of this release.
"This quarter we saw solid performance from our leading multiple sclerosis business as an increasing number of patients globally are benefiting from our diverse portfolio of therapies," said Chief Executive Officer George A. Scangos, Ph.D. "We are also excited to be offering patients a new treatment option with the introduction of ZINBRYTATM, a new therapy for multiple sclerosis. In our biosimilars business, we are pleased to have launched two new treatments in Europe: FLIXABI, a biosimilar of infliximab, and BENEPALI, a biosimilar of etanercept."
"We also made significant progress in several important pipeline programs," Dr. Scangos continued. "We completed the rolling submission of a New Drug Application to the FDA for nusinersen within two months of receiving the positive interim results from the ENDEAR study – Biogen’s fastest filing time in our 38 year history. Earlier this month, we also filed a Marketing Authorization Application with the European Medicines Agency. If approved, nusinersen would be the first treatment for patients with spinal muscular atrophy, a leading genetic cause of death in infants. In addition, we believe aducanumab, our Phase 3 candidate for early Alzheimer’s disease, continues to show promise, and we are encouraged by both the growing body of data from the Phase 1b PRIME study as well as the Fast Track designation it recently received from the FDA."
Revenue Highlights
(In millions) Q3 ‘16 Q2 ‘16 Q3 ‘15 Q3 ‘16 v. Q2 ‘16 Q3 ‘16 v. Q3 ‘15
Multiple Sclerosis:
TECFIDERA $ 1,034 $ 987 $ 937 5 % 10 %
Total Interferon $ 708 $ 728 $ 785 (3 %) (10 %)
AVONEX $ 580 $ 606 $ 685 (4 %) (15 %)
PLEGRIDY $ 128 $ 123 $ 100 4 % 28 %
TYSABRI $ 515 $ 497 $ 480 4 % 7 %
FAMPYRA $ 21 $ 22 $ 21 (3 %) (0 %)
ZINBRYTA $ 2 - - NMF NMF
Hemophilia:
ELOCTATE $ 132 $ 125 $ 91 6 % 46 %
ALPROLIX $ 85 $ 80 $ 66 6 % 30 %
Other Product Revenues:
FUMADERM $ 11 $ 12 $ 12 (4 %) (9 %)
Biosimilars $ 31 $ 15 $ - 101 % NMF
Total Product Revenues: $ 2,540 $ 2,466 $ 2,392 3 % 6 %
Anti-CD20 Revenues $ 318 $ 349 $ 337 (9 %) (6 %)
Other Revenues $ 99 $ 79 $ 49 25 % 101 %
Total Revenues $ 2,956 $ 2,894 $ 2,778 2 % 6 %
Note: Numbers may not foot due to rounding
Expense Highlights
(In millions) Q3 ‘16 Q2 ‘16 Q3 ‘15 Q3 ‘16 v. Q2 ‘16 Q3 ‘16 v. Q3 ‘15
GAAP cost of sales $ 417 $ 370 $ 310 (13 %) (34 %)
Non-GAAP cost of sales $ 396 $ 354 $ 310 (12 %) (28 %)
GAAP R&D $ 529 $ 473 $ 520 (12 %) (2 %)
Non-GAAP R&D $ 529 $ 473 $ 520 (12 %) (2 %)
GAAP SG&A $ 463 $ 492 $ 478 6 % 3 %
Non-GAAP SG&A $ 461 $ 489 $ 478 6 % 4 %
Note: Percent changes represented as favorable & (unfavorable)
Cost of sales for the third quarter of 2016 was negatively impacted by approximately $25 million due to a mid-single digit royalty on US sales of AVONEX and PLEGRIDY.
R&D expense for the third quarter of 2016 includes a $75 million payment to Ionis Pharmaceuticals in connection with Biogen’s exercise of its opt-in right to develop and commercialize nusinersen globally.
During the third quarter of 2016, Biogen recognized $13 million in restructuring charges primarily related to organizational changes associated with the anticipated spin-off of Bioverativ, as well as additional cost saving measures.
Other Financial Highlights
For the third quarter of 2016, the Company’s weighted average diluted shares were 219 million.
As of September 30, 2016, Biogen had cash, cash equivalents and marketable securities totaling approximately $7.4 billion, and $6.5 billion in notes payable and other financing arrangements.
During the third quarter of 2016, Biogen repurchased 1.1 million shares of the Company’s common stock for a total value of $349 million.
Recent Events
In October 2016, Biogen and Ionis Pharmaceuticals presented new data from the clinical program for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), at the 2016 World Muscle Society Congress in Granada, Spain. Initial data from the Phase 3 ENDEAR study in infantile-onset (consistent with Type 1) SMA demonstrated a favorable safety profile, and analysis of the ongoing Phase 2 open-label NURTURE study demonstrated a beneficial effect in infants prior to the onset of symptoms. These presentations followed the announcement in August 2016 that nusinersen met the primary endpoint pre-specified for the interim analysis of ENDEAR, which showed that infants receiving nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared with those who did not receive treatment.
In October 2016, Biogen filed a Marketing Authorization Application with the European Medicines Agency, which had already granted Accelerated Assessment status to nusinersen. Earlier in September 2016, Biogen completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of nusinersen. Biogen has also applied for Priority Review which, if granted, would shorten the review period of nusinersen following the FDA’s acceptance of the NDA.
In September 2016, Biogen presented updated clinical findings from its broad portfolio of multiple sclerosis (MS) therapies at the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London. Presentations included real-world data and new clinical evidence demonstrating that TECFIDERA consistently delivers strong, sustained efficacy in relapsing-remitting MS while affirming its well-characterized safety profile. Also presented were a new analysis from the pivotal DECIDE study that further supports the positive impact of ZINBRYTA on "no evidence of disease activity" (NEDA) and detailed results evaluating opicinumab (anti-LINGO-1) in people with relapsing forms of MS from the Phase 2 SYNERGY study.
In September 2016, Biogen announced that aducanumab, an investigational treatment for early Alzheimer’s disease, was granted Fast Track designation by the FDA. Biogen also announced that in a recently completed interim analysis from PRIME, the ongoing Phase 1b study of aducanumab in early Alzheimer’s disease, efficacy and safety data were consistent with results previously reported. These data support the design of the ongoing Phase 3 ENGAGE and EMERGE studies, and Biogen plans to share detailed information about these results at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego on December 9, 2016.
In August 2016, results from pre-clinical research and the Phase 1b PRIME study for aducanumab in early Alzheimer’s disease were published in Nature. The full manuscript titled "The Antibody Aducanumab Reduces Aβ Plaques in Alzheimer’s Disease" can be found in the September 1, 2016 issue of Nature View Source
In August 2016, Biogen announced that Bioverativ will be the name of the independent, publicly-traded global biotechnology company that it expects to spin off in early 2017. Bioverativ will be focused on the discovery, development and commercialization of treatments for hemophilia and other blood disorders. Following completion of the spin-off, Bioverativ plans to trade under the symbol "BIVV" on the NASDAQ Stock Market.
Biogen has discontinued development of amiselimod (MT-1303).