Sector News

Still reeling from aducanumab flop, Biogen executives lay their cards on the table

April 25, 2019
Life sciences

When drugmakers report their quarterly numbers, executives like to accentuate the positive. But sometimes, calamity forces them to do the opposite.

Biogen’s top brass squared up to that task Wednesday, in the wake of a spectacular phase 3 failure for aducanumab, its closely watched late-stage Alzheimer’s candidate. But that drug’s demise wasn’t the only problem executives hashed out during their first-quarter earnings call.

The multiple sclerosis med Tecfidera—Biogen’s top drug by sales—faces numerous intellectual property challenges, and its MS franchise as a whole fell short for the quarter. The company’s up-and-comer Spinraza, a fast-growing treatment for spinal muscular atrophy, faces impending competition from Novartis’ gene therapy Zolgensma. And though Biogen generated $3.5 billion in Q1 revenue, up 11% year-over-year, analysts on Wednesday’s call were less interested in its financial performance than in its pipeline and strategy looking forward.

Biogen has the “opportunity and obligation” to rebound, CEO Michel Vounatsos assured the analysts and reminded them that the company will continue buying back shares to keep investors interested in the meantime. After the aducanumab flop cratered the stock, Biogen announced a $5 billion buyback plan.

That’ll leave less money for M&A, but Biogen does plan to continue scouting for deals in its focus areas, Vounatsos said, following up on comments at the J.P. Morgan Healthcare Conference in January.

Meanwhile, multiple threats loom over Biogen’s big-selling MS med Tecfidera, which chipped in $999 million in the first quarter. The U.S. Patent and Trademark Office plans to review its patents, while the company defends its IP in federal court. Meanwhile, Vountasos said, Biogen should have the chance to launch Vumerity, a follow-up oral MS med up for an FDA decision by year’s end. Bernstein analysts have said the drug could generate $734 million by 2022 as Tecfidera sales sink.

Then there’s fast-launching Spinraza, the company’s pricey spinal muscular atrophy med, which has trounced expectations so far. It pulled in $518 million for the quarter, but Novartis’ AveXis unit is expected to roll out its rival, Zolgensma, later this year, and market-watchers worry how Spinraza will fare.

After all, as a gene therapy, Zolgensma is designed as a one-time cure. But as pricey as Spinraza is—$750,000 for the first year and $375,000 annually after that—Zolgensma will be far more expensive as a lump sum, with prospective price tags that range from $2 million to $4 million and beyond. And Biogen execs said they believe Spinraza will “remain the standard of care for years to come.”

Biogen has doubled down on biosimilars as competitive threats mount elsewhere; last year it opted to boost its investment in BioEpis, its biosim-focused joint venture with Samsung. And for Q1, Biogen’s biosims pulled in $175 million, partly in thanks to its BioEpis-partnered Humira copycat Imraldi, which is the top biosim to that med by market share in Europe after launching in October.

Looking ahead, Biogen aims to keep advancing its pipeline and scouting new drug candidates, execs said Wednesday. The company now focuses on multiple sclerosis, SMA and biosims, but it’s planning to advance into ophthalmology, movement disorders, neuromuscular diseases, stroke and more in the 2020s, the company said in an investor presentation. It’s still fanning its ambitions in pain, Alzheimer’s and neurocognitive disorders as well.

By Eric Sagonowsky

Source: Fierce Pharma

comments closed

Related News

September 25, 2022

Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences

Life sciences

Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence.

September 25, 2022

Mount Sinai AI uncovers new brain analysis method to predict dementia, Alzheimer’s disease

Life sciences

Current methods for diagnosing Alzheimer’s disease rely on a complex combination of self- and caregiver-reported symptoms, a physical examination and either a PET scan or a spinal tap to look for evidence of amyloid plaque build-ups in the brain. But a new artificial intelligence-based method may make the diagnostic process a much more objective one.

September 25, 2022

New AstraZeneca-backed report finds big money behind diverse owners and entrepreneurs in Europe

Life sciences

There is lots of talk about diversity and inclusion in business, including in pharma and medtech. A new report by the Open Political Economy Network (OPEN), a think tank focusing on migration and diversity, released its “Minority Businesses Matter: Europe” report highlighting the successes and challenges of ethnic minority-owned businesses in Europe.