Post by icemandios on Oct 20, 2021 15:21:48 GMT
Updated: Biogen sells just $300K worth of Aduhelm in Q3, as questions on long-term viability remain
Zachary Brennan
Senior Editor
Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.
Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.
“The potential uptake of Aduhelm in the US is delayed, but we continue to believe in its long-term potential,” Biogen CEO Michel Vounatsos said in a statement Wednesday. He also said on the earnings call that he’s “obviously disappointed with the delayed uptake,” and Biogen’s financial guidance assumes minimal Aduhelm revenue in 2021, but “ramping thereafter.” How much that revenue ramps up remains an open question.
Alisha Alaimo
Biogen’s US president Alisha Alaimo said on its earnings call that so far about 120 sites have infused at least one patient with Aduhelm, but several hundred sites are still in the queue. Morgan Stanley previously predicted about 14,000 patients will access Aduhelm by the end of 2022, but again, it’s unclear if Biogen will hit that goal.
“We’re not panicking because it’s a long way to go,” Vounatsos added.
Part of the reason the numbers remain so small currently is that insurers are still waiting on the CMS’ national coverage decision for Aduhelm, so reimbursement for the treatment is not happening on a wide scale. A draft of the NCD is expected in January and a final version is set for April.
But the NCD also isn’t just for Aduhelm, but for all monoclonal antibodies that target amyloid, which may be to Biogen’s advantage. The company said it’s responding to CMS data requests and noted on Wednesday’s earnings call that of the 12 NCDs performed by CMS in its history, only 1 didn’t end up with coverage.
So far, the numbers have not been anywhere close to Wall Street’s expectations. SVB Leerink recently lowered its Q3 Aduhelm sales projections from ~$11M to ~$6M. The investment bank also lowered its 2021 Aduhelm sales from ~$68M to ~$31M, and from ~$1.1B to ~$525M in 2022. Evercore ISI analysts on Wednesday also took issue with the $1 billion consensus estimate for 2022 Aduhelm sales, which implies more than 75,000 patients on Aduhelm in 2022.
“It’s my opinion that 2022 US revs should be closer to ~$200M,” Evercore ISI’s Umer Raffat wrote.
Al Sandrock
Another analyst asked Biogen on its earnings call why it doesn’t lower the $56,000 price tag for Aduhelm, given the slow initial rollout. But neither Vounatsos nor Alaimo seemed to suggest that was an option.
And beyond the dismal early sales, Biogen still has to run a confirmatory trial to show the FDA that Aduhelm really does work.
Al Sandrock, head of R&D at Biogen, said on Wednesday’s earnings call that the company aims to complete the confirmatory study ahead of its nine-year deadline, and it has submitted a draft protocol of of its confirmatory study for aducanumab to the FDA.
Sandrock also said Biogen still plans to publish its aducanumab data from the clinical trials used for the FDA’s accelerated approval in a major peer-reviewed journal soon, according to a spokesperson’s notes. The company said the same on the last earnings call in July.
Aducanumab is still under regulatory review in the EU.
Editor’s note: Article updated to note that Al Sandrock said Biogen still plans to publish the Phase 3 results for aducanumab.
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Zachary Brennan
Senior Editor
Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.
Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.
“The potential uptake of Aduhelm in the US is delayed, but we continue to believe in its long-term potential,” Biogen CEO Michel Vounatsos said in a statement Wednesday. He also said on the earnings call that he’s “obviously disappointed with the delayed uptake,” and Biogen’s financial guidance assumes minimal Aduhelm revenue in 2021, but “ramping thereafter.” How much that revenue ramps up remains an open question.
Alisha Alaimo
Biogen’s US president Alisha Alaimo said on its earnings call that so far about 120 sites have infused at least one patient with Aduhelm, but several hundred sites are still in the queue. Morgan Stanley previously predicted about 14,000 patients will access Aduhelm by the end of 2022, but again, it’s unclear if Biogen will hit that goal.
“We’re not panicking because it’s a long way to go,” Vounatsos added.
Part of the reason the numbers remain so small currently is that insurers are still waiting on the CMS’ national coverage decision for Aduhelm, so reimbursement for the treatment is not happening on a wide scale. A draft of the NCD is expected in January and a final version is set for April.
But the NCD also isn’t just for Aduhelm, but for all monoclonal antibodies that target amyloid, which may be to Biogen’s advantage. The company said it’s responding to CMS data requests and noted on Wednesday’s earnings call that of the 12 NCDs performed by CMS in its history, only 1 didn’t end up with coverage.
So far, the numbers have not been anywhere close to Wall Street’s expectations. SVB Leerink recently lowered its Q3 Aduhelm sales projections from ~$11M to ~$6M. The investment bank also lowered its 2021 Aduhelm sales from ~$68M to ~$31M, and from ~$1.1B to ~$525M in 2022. Evercore ISI analysts on Wednesday also took issue with the $1 billion consensus estimate for 2022 Aduhelm sales, which implies more than 75,000 patients on Aduhelm in 2022.
“It’s my opinion that 2022 US revs should be closer to ~$200M,” Evercore ISI’s Umer Raffat wrote.
Al Sandrock
Another analyst asked Biogen on its earnings call why it doesn’t lower the $56,000 price tag for Aduhelm, given the slow initial rollout. But neither Vounatsos nor Alaimo seemed to suggest that was an option.
And beyond the dismal early sales, Biogen still has to run a confirmatory trial to show the FDA that Aduhelm really does work.
Al Sandrock, head of R&D at Biogen, said on Wednesday’s earnings call that the company aims to complete the confirmatory study ahead of its nine-year deadline, and it has submitted a draft protocol of of its confirmatory study for aducanumab to the FDA.
Sandrock also said Biogen still plans to publish its aducanumab data from the clinical trials used for the FDA’s accelerated approval in a major peer-reviewed journal soon, according to a spokesperson’s notes. The company said the same on the last earnings call in July.
Aducanumab is still under regulatory review in the EU.
Editor’s note: Article updated to note that Al Sandrock said Biogen still plans to publish the Phase 3 results for aducanumab.
RELATED ARTICLES