Before Biogen won approval for controversial Alzheimer's disease drug Aduhelm, the company had been facing down competitive threats to key medicines. Now that Aduhelm is on the market and barely generating any sales, the company could be in an even more challenging position than it was before.
In fourth-quarter results released Tuesday, Biogen said Aduhelm generated just $1 million during the final three months of the year and $3 million for all of 2021. That pales in comparison to the $480 million Biogen reported in full-year selling, general and administrative (SG&A) expenses related to the drug. Of the SG&A total, Biogen's partner Eisai chipped in $135 million for U.S. expenses.
Biogen won an accelerated approval for Aduhelm in June 2021 based on questionable data. The drugmaker slapped a $56,000 price tag to start, prompting intense pushback that led it cut the price to $28,200 for a patient of average weight.
Still, with the Centers for Medicare & Medicaid Services (CMS) proposing to limit Medicare coverage to only patients on approved clinical trials, the company right now expects only "minimal" revenue contributions from Aduhelm in 2022.
Speaking with analysts Thursday, Biogen CEO Michel Vounatsos said CMS believes there are “gaps in the data” on the drug’s efficacy and wants to know more about risks of treatment with the medicine. Further, CMS wants additional data on the med's efficacy and safety in underrepresented populations.
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For its part, Biogen believes that because the drug is approved, the best place to collect these data is in the real-world treatment setting. Vounatsos argued that CMS' draft decision, if finalized, would be “prohibitive for patients, overly burdensome, costly for companies and duplicative of the data that would be generated from ongoing trials.” Biogen is running two phase 4 trials, ENVISION and ICARE-AD, that will together enroll up to 7,500 patients and aim to deliver more info on the medicine, he said.
In addition, Biogen's CEO has urged patients and advocates to submit comments to CMS during the agency's 30-day open comment period on the review. A final decision is expected in April. Biogen plans to submit its "in-depth" comments "in the coming days," the company's U.S. president Alisha Alaimo said Thursday.
Writing to clients after Biogen's conference call, Mizuho analyst Salim Syed said he planned to ask Biogen management at what point they would consider pulling the drug from the market. He wondered how long the company could market a drug with a negative net present value "before the fiduciary duty kicks in to shut down the program."
In all last year, Biogen pulled in $10.98 billion in revenues, a 19% decline from 2020 at constant currencies. The company recorded multiple sclerosis revenues of $7.09 billion, a 19% decline, as generics to Tecfidera continued to take a bite out of U.S. sales. Revenues for Spinraza, the company's blockbuster spinal muscular atrophy treatment, fell 9% to $1.9 billion as newer rivals fight for market share.
Biogen's biosimilars pulled in $831 million, a 1% increase at constant currencies. Biogen is planning to exit its biosimilars joint venture with Samsung Bioepis through a stake sale unveiled last week.
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Reflecting on the 2021 figures, Vounatsos said the results outline the company's ability to "execute well." Still, he acknowledged the challenges the company is facing and noted Biogen is planning $500 million in cost cuts. The company says it plans to take further cost-cutting measures if the CMS' final decision is not broader than the draft guidance.
For 2022, the company expects $9.7 billion to $10 billion in global sales. The guidance assumes "minimal" revenue from Aduhelm, the company said, and it assumes that the company won't have to write off any Aduhelm inventory this year. As of the end of 2021, that inventory is valued at about $225 million.
In the long run, Biogen assumes that CMS will allow more Aduhelm uptake over time. If the agency restricts coverage over several years, Biogen is working through scenarios about how it would respond, Chief Financial Officer Michael McDonnell said Thursday.
Editor's note: This story was updated with input from Mizuho analyst Salim Syed.