Biogen stock up some 5% premarket after first-quarter earnings beat

Biogen Reports First Quarter 2017 Revenues of $2.8 Billion

BUZ INVESTORS PRESS RELEASE Biogen first-quarter earnings   Biogen Inc. (NASDAQ: BIIB) today reported first quarter 2017 financial results, including:

BUZ INVESTORS PRESS RELEASE Biogen first-quarter earnings   Biogen Inc. (NASDAQ: BIIB) today reported first quarter 2017 financial results, including:

  • Total revenues of $2.8 billion, a 3% increase versus the prior year and an 8% increase excluding hemophilia revenues*.
    • TYSABRI® revenue grew 14% versus the prior year. Outside the U.S., TYSABRI revenues benefited by approximately $45 million due to reaching an agreement with the Price and Reimbursement Committee of the Italian National Medicines Agency (AIFA) related to TYSABRI sales in prior periods.
    • Versus Q4 2016, Biogen estimates TECFIDERA® U.S. revenues were negatively impacted by approximately $50 million to $60 million due to lower inventory levels in the channel.
    • Worldwide SPINRAZA® revenues were $47 million.
  • GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. of $748 million and $3.46, respectively.
    • GAAP net income and diluted EPS were negatively impacted by $263 million and $1.22, net of tax, respectively, related to the settlement and license agreement with Forward Pharma including consideration of the U.S. Patent and Trademark Office (USPTO) ruling in favor of Biogen in the interference proceeding.
  • Non-GAAP net income and diluted EPS attributable to Biogen Inc. of $1.1 billion and $5.20, respectively.

* Total Q1 2017 revenues include hemophilia revenues only for the month of January. The 8% increase in total revenues excludes all hemophilia revenues from Q1 2016 and January 2017. Hemophilia revenues include ELOCTATE® and ALPROLIX® product revenues as well as royalty and contract manufacturing revenue related to Sobi.

Biogen first-quarter earnings


(In millions, except per share amounts) Q1 ’17 Q4 ’16 Q1 ’16

Q1 ’17 v.
Q4 ’16

Q1 ’17 v.
Q1 ’16

Total revenues** $ 2,811 $ 2,872 $ 2,727 (2%)** 3%**
GAAP net income*** $ 748 $ 649 $ 971 15 % (23 %)
GAAP diluted EPS $ 3.46 $ 2.99 $ 4.43 16 % (22 %)
Non-GAAP net income*** $ 1,123 $ 1,093 $ 1,049 3 % 7 %
Non-GAAP diluted EPS $ 5.20 $ 5.04 $ 4.79 3 % 9 %

** Total revenues grew 4% versus Q4 2016 and 8% versus Q1 2016 excluding hemophilia.
***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 press release.

“I am very pleased with the results of the first quarter. We saw continued stability in our MS business, executed a strong launch of SPINRAZA, grew market share for our biosimilars business across Europe, and reinforced the intellectual property for TECFIDERA,” said Chief Executive Officer Michel Vounatsos. “Furthermore, we continued to build our neurology pipeline with the anticipated addition of our new Phase 2-ready anti-tau antibody.”

“We are encouraged by the progress we made launching SPINRAZA in the U.S., and, following the positive CHMP opinion, we are ramping up pre-launch activities in Europe. The value this therapy provides to patients is compelling, and we are working to accelerate patient access globally,” Vounatsos continued. “Overall, I believe we’re building positive momentum at the company, and I look forward to leading Biogen into a new and exciting era.”

Revenue Highlights

(In millions) Q1 ’17 Q4 ’16 Q1 ’16

Q1 ’17 v.
Q4 ’16

Q1 ’17 v.
Q1 ’16

Multiple Sclerosis:
TECFIDERA $ 958 $ 1,002 $ 946 (4 %) 1 %
Total Interferon $ 648 $ 688 $ 670 (6 %) (3 %)
AVONEX ® $ 537 $ 564 $ 564 (5 %) (5 %)
PLEGRIDY ® $ 112 $ 125 $ 106 (10 %) 5 %
TYSABRI $ 545 $ 474 $ 477 15 % 14 %
FAMPYRATM $ 20 $ 22 $ 20 (7 %) 1 %
ZINBRYTA ® $ 11 $ 6 $ 81 % NMF
ELOCTATE**** $ 48 $ 149 $ 108 (68 %) (55 %)
ALPROLIX**** $ 26 $ 93 $ 75 (72 %) (65 %)
Spinal Muscular Atrophy
Other Product Revenues:
Biosimilars $ 66 $ 53 $ 2 25 % NMF
FUMADERMTM $ 10 $ 11 $ 11 (15 %) (15 %)
Total Product Revenues: $ 2,380 $ 2,503 $ 2,309 (5 %) 3 %
Anti-CD20 Revenues $ 341 $ 318 $ 329 7 % 3 %
Other Revenues**** $ 90 $ 51 $ 88 77 % 2 %
Total Revenues** $ 2,811 $ 2,872 $ 2,727 (2%)** 3%**

Note: Numbers may not foot due to rounding; percent changes represented as favorable & (unfavorable)
**** Q1 2017 ELOCTATE and ALPROLIX revenues reflect only the month of January, prior to the spin-off of our hemophilia business. Other revenues include royalty and contract manufacturing revenue related to Sobi only for the month of January.

Expense Highlights

(In millions) Q1 ’17 Q4 ’16 Q1 ’16

Q1 ’17 v.
Q4 ’16

Q1 ’17 v.
Q1 ’16

GAAP cost of sales $ 385 $ 378 $ 313 (2 %) (23 %)
Non-GAAP cost of sales $ 385 $ 363 $ 313 (6 %) (23 %)
GAAP R&D $ 423 $ 534 $ 437 21 % 3 %
Non-GAAP R&D $ 421 $ 531 $ 437 21 % 4 %
GAAP SG&A $ 499 $ 496 $ 497 (1 %) (0 %)
Non-GAAP SG&A $ 483 $ 484 $ 497 0 % 3 %

Note: Percent changes represented as favorable & (unfavorable)

  • Biogen also recorded GAAP-only pre-tax charges in Q1 2017 of $354 million related to the settlement and license agreement with Forward Pharma including consideration of the USPTO ruling in favor of Biogen in the interference proceeding. These charges are included in amortization of acquired intangible assets and exceed the amounts anticipated in Biogen’s previously announced 2017 full year GAAP financial guidance related to this agreement.

Other Financial Highlights

  • As of March 31, 2017, Biogen had cash, cash equivalents and marketable securities totaling approximately $5.7 billion, and approximately $6.5 billion in notes payable and other financing arrangements.
  • For the first quarter of 2017, the Company’s weighted average diluted shares were approximately 216 million. The Company ended the quarter with approximately 214 million basic shares outstanding.
  • During the first quarter of 2017, Biogen repurchased approximately 2 million shares of the Company’s common stock for a total value of $584 million. Since the end of the quarter, the Company has repurchased an additional approximately 2 million shares for a total value of $543 million.

Business Development Highlights

  • In April 2017, Biogen announced an agreement with Bristol-Myers Squibb to exclusively license BMS-986168, an experimental medicine with potential in Alzheimer’s disease and progressive supranuclear palsy (PSP), a rare condition that affects movement, speech, vision, and cognitive function. Biogen plans to initiate Phase 2 studies for BMS-986168 in both of these indications. Biogen anticipates making an upfront payment of $300 million to Bristol-Myers Squibb in the second quarter of 2017 as well as a near-term $60 million milestone payment to the former stockholders of iPierian, Inc. upon initiation of a Phase 2 trial for BMS-986168. These amounts exceed the estimated $100 million in business development expense assumed in Biogen’s previously announced 2017 full year financial guidance. This agreement is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the second quarter of 2017.

Other Recent Events

  • At the 69th annual meeting of the American Academy of Neurology (AAN) being held in Boston from April 22 to April 28, 2017, Biogen is presenting data from its portfolio of treatments and investigational therapies for people with serious neurological and neurodegenerative diseases. Platform and poster presentations include new real-world evidence supporting TECFIDERA and TYSABRI, underscoring the importance of early and appropriate treatment for multiple sclerosis (MS); new data demonstrating the clinically meaningful efficacy and favorable benefit-risk profile of SPINRAZA for spinal muscular atrophy; and previously presented results from the Phase 1b studies of aducanumab, an investigational treatment for early Alzheimer’s disease.
  • In April 2017, Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorization in the European Union (EU) for SPINRAZA (nusinersen) to treat patients with spinal muscular atrophy. The CHMP reviewed SPINRAZA under an accelerated assessment procedure, which is a regulatory mechanism to facilitate earlier access to patients for medicines that fulfill unmet medical needs. SPINRAZA is the first treatment for spinal muscular atrophy to be recommended by the CHMP for approval in the EU.
  • In March 2017, the USPTO ruled against the Coalition for Affordable Drugs V LLC, an entity associated with a hedge fund, in the inter partes review of Biogen’s U.S. Patent No. 8,399,514 (the ‘514 patent). The ‘514 patent includes claims covering the treatment of MS with 480 mg of dimethyl fumarate as provided for in Biogen’s TECFIDERA label.
  • In March 2017, the USPTO ruled against Forward Pharma in the interference proceeding between Forward Pharma’s pending U.S. Patent Application No. 11/576,871 and the ‘514 patent.
  • In March 2017, Biogen presented data from its Alzheimer’s and Parkinson’s disease programs at the 13th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) in Vienna, Austria. The Biogen presentations included data from research of Alzheimer’s and Parkinson’s disease biomarkers; the investigational treatment for Alzheimer’s disease, aducanumab; and the investigational treatment for Parkinson’s disease, BIIB054.
  • In March 2017, Roche announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for the treatment of certain blood cancers. This new co-formulation includes the same monoclonal antibody as intravenous RITUXAN® (rituximab) and hyaluronidase, a molecule that helps to deliver medicine under the skin. The FDA is expected to make a decision on approval by June 26, 2017. Roche and Biogen collaborate on RITUXAN in the U.S.
  • In March 2017, Biogen appointed Anirvan Ghosh, Ph.D. as Senior Vice President, Research and Early Development (RED). Dr. Ghosh will lead Biogen’s RED organization in the discovery and development of drug candidates from idea through proof of concept.
  • In February 2017, Biogen announced the completion of the separation of its global hemophilia business. The new company, known as Bioverativ, is an independent, publicly traded global biotechnology company focused on hemophilia and other rare blood disorders. Bioverativ trades under the symbol “BIVV” on the NASDAQ Global Select Market.
  • In January 2017, Siemens Healthineers and Biogen announced plans to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of MS disease activity and progression.
  • In January 2017, Biogen initiated a Phase 1 trial of an anti-tau monoclonal antibody, BIIB076, in healthy volunteers and participants with Alzheimer’s disease. BIIB076 was derived from Neurimmune’s reverse translational medicine platform.

Conference Call and Webcast
The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:30 a.m. ET on April 25, 2017, and will be accessible through the Investors section of Biogen’s homepage, www.biogen.com . Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the conference call and will be subsequently available on the website for at least one month.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com . Follow us on social media – Twitter , LinkedIn , Facebook , YouTube .

Biogen first-quarter earnings

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Richard Dambrosi (JADTECNIC) Has Been Sharing FOREX INVESTORS ANALYSIS FORECAST since 2011. Editors and Founder of InvestorsBuz.com, has a passion for Forex Social Sharing analysis and Market Trends Such as Self Driving Cars, Electric Cars, Medical Marijuana, 3d printing and Cloud computing, Refers to Readers as BUZ INVESTORS.

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