On October 23, 2018 Biogen Inc. (Nasdaq: BIIB) reported third quarter 2018 financial results, including (Press release, Biogen, OCT 23, 2018, View Source [SID1234530371]):

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 $3.4 billion, a 12% increase versus the prior year.

Multiple sclerosis (MS) revenues were $2.3 billion, including approximately $137 million in royalties on the sales of OCREVUS, relatively stable versus the third quarter of 2017.

Revenue growth was driven in part by SPINRAZA, which contributed $468 million in global revenues.

GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. of $1.4 billion and $7.15, respectively, compared to $1.2 billion and $5.79 in the third quarter of 2017, respectively.

Non-GAAP net income and diluted EPS attributable to Biogen Inc. of $1.5 billion and $7.40, respectively, compared to $1.3 billion and $6.31 in the third quarter of 2017, respectively

Biogen performed well against our strategic and operational priorities in the most recent quarter," said Michel Vounatsos, Biogen’s chief executive officer. "Reported revenues grew at a double-digit rate boosted by strong gains from SPINRAZA, our biosimilars business, and OCREVUS royalties versus a year ago. Net income and earnings per share both increased at double-digit rates supported by a lower tax rate and a lower share count. Our core MS business was relatively resilient during the quarter. For SPINRAZA, in the U.S. we saw increased new patient demand among adults. Outside of the U.S., SPINRAZA revenues benefitted from strong patient uptake across a number of geographies, as well as broadening approvals and solid reimbursement patterns."

"Biogen continued to advance our pipeline beyond our industry leading portfolios in MS and Alzheimer’s," Mr. Vounatsos continued. "In the third quarter, we made notable progress in stroke, progressive supranuclear palsy, and ALS. As ever, we remain focused on allocating our capital properly and efficiently with the goal of maximizing returns on behalf of our shareholders over the long-term."

In the third quarter of 2018 channel inventory levels in the U.S. were relatively stable for TECFIDERA, AVONEX, and PLEGRIDY combined. This compares to a decrease of approximately $45 million in the second quarter of 2018 and relatively stable inventory levels in the third quarter of 2017.

In the third quarter of 2018 SPINRAZA revenues comprised $224 million in sales in the U.S. and $244 million in sales outside the U.S. The number of commercial patients receiving SPINRAZA grew approximately 11% in the U.S. and approximately 29% outside the U.S. versus the second quarter of 2018. In the third quarter of 2018 Biogen recorded SPINRAZA revenues in over 30 countries.

Other Financial Highlights

In the third quarter of 2018 GAAP amortization of acquired intangibles was $282 million, including impairment charges totaling $189 million related to updates in the development status of vixotrigine (BIIB074), which are discussed below. The effects of these impairments were partially offset by a $90 million reduction in our contingent consideration liability.

In the third quarter of 2018 GAAP other net income was $115 million. This includes a gain of approximately $141 million related to changes in the fair value of certain equity investments, including shares of Ionis Pharmaceuticals, Inc., as of September 30, 2018. Non-GAAP other net expense was $26 million.

For the third quarter of 2018 the Company’s effective GAAP tax rate was 20%, and the Company’s effective non-GAAP tax rate was 21%.

In the third quarter of 2018 Biogen’s board of directors authorized a program to repurchase up to $3.5 billion of the Company’s common stock.

As of September 30, 2018, Biogen had cash, cash equivalents, and marketable securities totaling approximately $5.7 billion, and approximately $5.9 billion in notes payable.

In the third quarter of 2018 the Company generated $1.7 billion in net cash flows from operations.

For the third quarter of 2018 the Company’s weighted average diluted shares were 202 million.

Recent Events

This week Biogen will present data from its Alzheimer’s disease (AD) clinical development portfolio at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting in Barcelona, Spain (October 24-27). Biogen will share a late-breaking oral presentation and a late-breaking poster on the efficacy of aducanumab, Biogen’s anti-amyloid beta antibody candidate for early AD, as well as cumulative safety data from the Phase 1b PRIME long-term extension study of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild AD dementia. These results are generally consistent with previous interim analyses, and there were no changes to the risk-benefit profile of aducanumab. In addition, Samantha Budd Haeberlein, vice president, Alzheimer’s disease, dementia, and movement disorders, late stage clinical development at Biogen, will deliver a keynote address focused on lessons learned from clinical research into AD. The oral presentation, keynote address, and an investor Q&A call, will be webcast on Biogen’s website at investors.biogen.com. The poster presentations will also be available on Biogen’s website.

Wednesday, October 24, 7:15 a.m. ET / 1:15 p.m. CEST – Poster Presentations: Cumulative Aducanumab Safety Data from PRIME: A Randomized, Double-blind, Placebo-controlled, Phase 1b Study and Aducanumab 48-Month Analyses from PRIME, a Phase 1b Study in Patients with Early Alzheimer’s Disease

Thursday, October 25, 7:30-8:00 a.m. ET / 1:30-2:00 p.m. CEST – Keynote: What Have We Learned from Aducanumab?

Thursday, October 25, 4:15 p.m. ET / 10:15 p.m. CEST – Investor Q&A call with Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen, and Samantha Budd Haeberlein, Ph.D., vice president, Alzheimer’s disease, dementia and movement disorders, late stage clinical development at Biogen
◦
Friday, October 26, 9:15-9:30 a.m. ET / 3:15-3:30 p.m. CEST – Oral Presentation: Aducanumab Titration Dosing Regimen: 36-Month Analyses from PRIME, a Phase 1b Study in Patients with Early Alzheimer’s Disease

At CTAD, Biogen’s collaborator Eisai Co., Ltd. (Eisai) will also present clinical and biomarker updates from the Phase 2 study of BAN2401, an anti-amyloid beta antibody, along with safety and efficacy data for elenbecestat (development code: E2609), an investigational oral beta-amyloid cleaving enzyme (BACE) inhibitor, from the Phase 2 study in MCI to moderate AD. The BAN2401 presentation will be webcast live on Eisai’s website on Thursday, October 25, 8:30-9:30 a.m. ET / 2:30-3:30 p.m. CEST.

Today Biogen and UCB announced top-line results from a Phase 2b study evaluating the safety and efficacy of dapirolizumab pegol (DZP), an anti-CD40L pegylated Fab, in adults with moderately-to-severely active systemic lupus erythematosus (SLE) despite receiving standard-of-care treatment such as corticosteroids, anti-malarials and non-biological immunosuppressants. The primary endpoint of the study to demonstrate a dose response at 24 weeks on the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) was not met (p=0.06). The study did demonstrate consistent and potentially meaningful improvements for the majority of clinical endpoints in patients treated with DZP compared with placebo. In addition, biomarker data demonstrated evidence of proof of biology. DZP was well tolerated and demonstrated an acceptable safety profile. Biogen and UCB continue to further evaluate these data while assessing potential next steps. The companies expect to present this data at a future scientific forum.

In October 2018 Biogen and Samsung Bioepis Co. Ltd. announced the European launch of IMRALDI, an adalimumab biosimilar referencing Humira. IMRALDI is approved in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, and uveitis.

In October 2018 Biogen presented data in more than 70 oral and poster presentations at the 34th Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Berlin, Germany. Key updates included clinical data and real-world evidence that further support the long-term efficacy and well-characterized safety of Biogen’s leading MS therapies, including data supporting the use of TECFIDERA and TYSABRI early within the disease course. Additional data highlighted the potential utility of serum neurofilament light (sNfL) as a biomarker of MS disease activity and updates on Biogen’s efforts to improve monitoring of cognition and other key MS outcomes through MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions).

In October 2018 Biogen presented new interim results from NURTURE, an ongoing open-label, single-arm efficacy and safety study of SPINRAZA in 25 presymptomatic infants with spinal muscular atrophy (SMA) at the Annual Congress of the World Muscle Society (WMS) held in Mendoza, Argentina. As of May 2018 all NURTURE study participants were alive and none required permanent ventilation, in contrast to the natural history of SMA. In addition, 100% of study participants achieved the motor milestone of sitting independently, 88% were able to walk with assistance, and 77% were able to walk independently. All NURTURE study participants were older than 15 months at the time of the analysis.

In October 2018 Biogen presented data from its movement disorders portfolio at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Hong Kong. Data presented included safety data from the Phase 1 long-term extension study of BIIB092, an anti-tau antibody, in progressive supranuclear palsy (PSP), baseline demographics from the BIIB092 Phase 2 PASSPORT study in PSP, and the design of the BIIB054 Phase 2 SPARK study in Parkinson’s disease.

In September 2018 Biogen received results from the Phase 2b study of vixotrigine (BIIB074) in painful lumbosacral radiculopathy (PLSR). The study did not meet its primary or secondary efficacy endpoints, and the Company will discontinue development in this indication. The safety data were consistent with the profile reported in previous studies. In addition, the Company has delayed the initiation of the Phase 3 studies of vixotrigine in trigeminal neuralgia as it awaits the outcome of ongoing interactions with the U.S. Food and Drug Administration regarding the design of the Phase 3 studies, a more detailed review of the Phase 2b PLSR data, and insights from the ongoing Phase 2 study in small fiber neuropathy.

In September 2018 Biogen completed enrollment in the Phase 2b AFFINITY study, evaluating opicinumab as an add-on therapy in MS patients who are adequately controlled on their anti-inflammatory disease-modifying therapy (DMT), versus the DMT alone. Opicinumab is a first-in-class human monoclonal antibody directed against LINGO-1 and is being evaluated to determine its potential for improving pre-existing disability in relapsing MS patients through remyelination.

In September 2018 Biogen enrolled the first patient in the Phase 2b study evaluating BG00011 (STX-100) in idiopathic pulmonary fibrosis.

In September 2018 Biogen completed enrollment in the Phase 2 study of BIIB092 in PSP.

In September 2018 Biogen enrolled the first patient in the Phase 1 study evaluating BIIB078 (IONIS-C9Rx), an antisense oligonucleotide drug candidate, in adults with C9ORF72-associated amyotrophic lateral sclerosis.

In August 2018 Biogen enrolled the first patient in the global Phase 3 CHARM study, designed to evaluate BIIB093 (intravenous (IV) glibenclamide) for the prevention and treatment of severe cerebral edema in large hemispheric infarction, one of the most severe types of ischemic stroke.

In July 2018 Eisai presented detailed results from the Phase 2 study (Study 201) of BAN2401, as well as detailed results from the Phase 2 study (Study 202) of elenbecestat, at the 2018 Alzheimer’s Association International Conference (AAIC) in Chicago.

Conference Call and Webcast
The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:00 a.m. ET on October 23, 2018, and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least one month.

Note about Earnings Releases and Calls
Starting with the second quarter 2018 earnings release, Biogen has ceased publishing press releases relating to future earnings calls, earnings releases, and investor events via newswire services. The Company will post these materials on the Investors section of Biogen’s website, www.biogen.com, and issue a statement on Twitter (@biogen) when they become available.