Drugmaker Biogen said Wednesday that Aduhelm, its new Alzheimer’s drug, generated $ 300,000 in revenue between July and September. falls far short of the company’s goals and Wall Street expectations.
The sales figures that Biogen disclosed in their financial statements for the third quarter, the first full period of drug availability, represent an extremely slow start to treatment that was introduced with an annual price of $ 56,000 and expectations that this would overload Medicare’s budget within some years. The drug’s popularity has slowed significantly due to fears by insurance companies, doctors and families that the drug has little evidence of effectiveness, but carries a significant risk of potentially serious side effects.
“This is a huge disappointment,” said Brian Skorney, an analyst at Robert W. Baird & Company.
“For a while, people talked about it being potentially the biggest drug in history,” he added. “There are no drugs that are so successful that really start off so slowly.”
Wall Street analysts predicted the drug would bring in at least $ 12 million in the third quarter, although expectations were moderate after news organization STAT reported last month that just over 100 patients received treatment in the first few months of its availability. Biogen shares were up about 0.3% on Wednesday.
Biogen did not disclose how many patients were treated between July and September. In the first few weeks of availability in June, the treatment generated $ 1.6 million in revenue, most of which came from stock. Biogen said Wednesday it expects Aduhelm to continue to generate marginal revenue for the rest of the year, damaging the company, which had counted on the drug to offset declines in revenue from other products.
Biogen chief executive Michel Vounatsos told analysts that the company “did not panic” about low sales and continued to “believe in the long-term potential of Aduhelm.” He blamed the low sales for the lack of clarity about whether insurance companies would pay for the drug.
The federal agency that runs Medicare said in July that it began a month-long survey to determine whether drug coverage should be standardized across the country, a move that could limit the number of patients getting it. The draft decision is expected in January, the final decision – by April.
Several well-known academic medical centers, including the Cleveland Clinic and Mount Sinai Health System in New York, have decided not to give the drug to patients. Several Blue Cross Blue Shield regional health plans refused to cover it, and in August the Department of Veterans Affairs decided not to add the drug to its list of available drugs.
In June, the FDA decided to approve Aduhelm, which is administered as a monthly intravenous infusion, despite conflicting clinical trial results and internal disagreement among its reviewers and advisers. In one study that was positive, the high dose of the drug slowed the decline by 0.39 on an 18-point scale. Usually mild but potentially serious side effects, such as cerebral edema or bleeding, were observed in 40 percent of clinical trial participants.
The agency’s independent advisory group and many outside academics opposed the approval decision. Several members of the commission left in protest. The FDA itself later called for a federal investigation into the process that led to approval.