By this point in Biogen’s highly scrutinized rollout of Alzheimer’s drug Aduhelm, market watchers expected that thousands of U.S. patients would be on the treatment. That reportedly hasn’t been the case, and some analysts are now concerned that Biogen doesn’t have enough pipeline prospects to shield it against potentially disappointing Aduhelm sales.
In a Wednesday note from Mizuho following Biogen’s R&D day—an opportunity for the drugmaker to highlight its prospects beyond Aduhelm—analyst Salim Syed wrote that the key Alzheimer's drug remains "remains commercially volatile at best."
Biogen spent 4 hours and 133 slides laying out its pipeline at the event, but didn't present a "clear case for growth" outside of its key Alzheimer's drug, the analyst wrote.
That could be a problem for Biogen’s growth prospects in case Aduhelm underwhelms estimates, which are still as high as $10 billion in peak sales, Syed said. That compares to Mizuho’s more conservative $6 billion peak sales expectations.
Even Biogen has acknowledged that its rollout has been even more gradual than the Cambridge, Massachusetts-based company had predicted. At a Morgan Stanley healthcare event earlier this month, CEO Michel Vounatsos said there's "clearly too much confusion, misinformation and controversy surrounding our data and the approval process." The launch has been "even more gradual than we had expected," he added.
How gradual? Well, it turns out just over 100 patients have been infused with the amyloid plaque-targeting antibody, far short of the roughly 10,000 patients that would need to be on the drug by year’s end to reach Wall Street’s revenue forecasts, Stat News reported Wednesday, citing a person familiar with the company’s efforts.
That could result in cost-cutting measures at the company, including layoffs, Stat reports.
A Biogen spokesperson told Fierce Pharma that the company is making "steady progress, including new site activations," and has "appropriately set expectations" surrounding Aduhelm's launch.
"Upgrading the infrastructure and establishing access pathways for a first of its kind medicine takes time," Biogen said in an emailed statement. Biogen also defended its "diversified pipeline of 33 programs with 12 of these in Phase 3 or filed for approval."
One key hurdle Biogen has faced has been the reluctance from payers. The company will have to wait until early next year for the Centers for Medicare & Medicaid Services' pivotal coverage decision that will determine whether federal insurance programs reimburse the treatment.
In the meantime, the Department of Veteran's Affairs decided last month against adding Aduhelm to its formulary. A spokesperson said the agency made the decision "due to the risk of significant adverse drug events and to the lack of evidence of a positive impact on cognition."
In another local example, Syed’s Mizuho note pointed out The Neurology Center in Washington D.C., which has taken a stringent stance on Aduhelm. Given its hefty price tag—an average of $56,000 annually per patient—and its murky clinical benefits, the clinic’s physicians have agreed to avoid administering the drug until its controversies are clarified, according to a note on its website.
When asked about the note, Biogen suggested that patients who have been denied access to Aduhelm contact the company.
RELATED: Biogen's controversial Alzheimer's med Aduhelm turned away by VA on efficacy and safety worries
Not all analysts see reason to panic. In another Wednesday note following Biogen’s investor day, Jefferies analysts called the company’s pipeline, which includes meds targeting Alzheimer’s, ALS and lupus, among others, “underappreciated.” Those candidates could be worth over $1 billion each, the analysts said.
To be sure, some of those programs may not work out given that they’re mostly high risk, high reward opportunities, Jefferies said. But they could prove to yield “lots of upside,” as long as investors are patient and can tolerate some pipeline risk, according to the note.
As for Alzheimer’s, the company has another mid-stage amyloid drug, known as lecanemab, in the works, as well as a tau-targeting hopeful BIIB080, Jefferies pointed out. Aduhelm has key regulatory decisions set in the UK and Japan in the coming months, as well, the team wrote.