Aduhelm Falls Drastically Short of Projections as Biogen Spins Positives

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Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) reported only $300,000 in third-quarter sales compared to original analyst average estimates of $10.79 million. It’s not surprising, given report after report of the company’s inability to gain traction among payers and physicians for the drug.

The drug was approved by the U.S. Food and Drug Administration on June 7, the first new Alzheimer’s drug authorized in 20 years. It was approved by the agency against the recommendation of its own Peripheral and Central Nervous System Drugs Advisory Committee, which voted against recommending it in November 2020. Three members of the panel have since resigned in protest.

The FDA also leveraged an Accelerated Approval pathway, which requires follow-up studies for continued approval. The approval was ultimately based on a surrogate endpoint, clearance of beta-amyloid, instead of relief of symptoms. The advisory committee had asked if the agency planned on using surrogate endpoints and was told the agency did not expect to do so.

In addition, the drug has a price tag of approximately $56,000 per patient per year. Although nowhere near being the most expensive drug on the market, the number of Alzheimer’s patients in the U.S. exceeds 3 million. Although Biogen and the FDA have since modified the drug’s label to early-stage disease, that is a very high expense for a large population of patients, most of which would be on Medicare. Many insurers have declined to reimburse for the drug until the Centers for Medicare and Medicaid Services (CMS) makes a final recommendation, which isn’t expected until at least January 2022, and probably not a final decision until March.

In the company’s third-quarter report, Biogen Chief Executive Officer Michel Vounatsos stated, “the potential uptake of Aduhelm in the U.S. is delayed, but we continue to believe in its long-term potential. At the same time, Biogen has continued to execute well across its leading MS, SMA and biosimilars businesses, and we are particularly encouraged by the ongoing launch of Vumerity.”

Biogen reported total revenue for the quarter of $2.779 billion, a drop of 18% compared to the same period in 2020. Its multiple sclerosis (MS) revenue, including royalties on Ocrevus sales, dropped 19% to $1.820 billion compared to the same period a year ago. Spinraza sales for SMA dropped 10% to $444 million compared to the third quarter 2020, and even biosimilars dropped 2% to $203 million.

For the full year 2021, the company updated its guidance, which seems surprisingly optimistic given the third quarter. For total revenue, Biogen is projecting $10.8 to $10.9 billion, up from the previous guidance of $10.65 to $10.85 billion, and for non-GAAP diluted earnings per share (EPS), they are projecting $18.85 to $19.35 compared to previous guidance of $17.50 to $19.00 per share.

Biogen says the guidance assumes minimal Aduhelm revenue for this year but has it increasing afterwards. It also takes into account erosion of Tecfidera and Rituxan in the U.S.

However, today the company’s stock popped 2.2% in premarket trading, apparently after it reported adjusted $4.77 per share for the quarter compared to a consensus estimate of $4.11 per share.

It’s possible that has more to do with yesterday’s news that Biogen and partner Sage Therapeutics are planning to submit a New Drug Application to the FDA for zuranolone for major depressive disorder (MDD) and an additional filing for postpartum depression (PPD). The first NDA is expected in the second half of 2022, with the PPD indication expected in the first half of 2023.

Barry Greene, chief executive officer of Sage, said, “In the clinical development programs, zuranolone has shown remarkably consistent, rapid, and sustained reductions in depressive symptoms, including anxiety and sleep loss, in addition to a well-tolerated safety profile. We believe we have a solid filing package with four adequate and well-controlled trials now in hand and, if approved, zuranolone will fill a real unmet need and be welcomed by people living with depression.”

On the other hand, Biogen announced two days ago that tofersen, its candidate for a rare form of amyotrophic lateral sclerosis (ALS), failed to hit the primary endpoint in the Phase III VALOR study. Still, the company put a positive spin on the failure, emphasizing favorable trends in several secondary and exploratory markers.