Biogen notes a slow start for Alzheimer’s drug
Biogen’s stock plunged Tuesday after the Cambridge biotech reported that the launch of its new Alzheimer’s treatment was off to a slow start and its earnings for the fourth quarter were weaker than expected.
Biogen stock lost more than 7 percent in trading Tuesday, closing at $226.65 per share on the NASDAQ exchange.
Seven months after US drug regulators fully approved Biogen’s treatment for Alzheimer’s disease, only about 2,000 patients are taking the medicine nationwide, the company said Tuesday.
Biogen’s chief executive, Christopher A. Viehbacher, told reporters ahead of an earnings call that he had expected the slow uptake and sees considerable demand for the medication. He said that 3,800 patients with early-stage Alzheimer’s have signed up on multiple registries to receive the drug, called Leqembi, as of last month.
Biogen and its Japanese business partner, Eisai, had previously said they hoped to have 10,000 patients on the drug by April. But Viehbacher said that was only an estimate and he always knew it would take time for patients to clear the necessary hurdles to receive Leqembi.
Before patients can get the drug, which costs $26,500 a year, they must undergo a brain scan or a spinal tap to confirm that they have built up deposits of a sticky toxic protein called beta-amyloid, which is a hallmark of the disease.
“The 10,000 isn’t really hard,” Viehbacher said, “and I think we are now focusing on commercial plans – how do we get to the next 100,000. There’s plenty of demand from patients.”
The key, he added, is the health care system “being able to accommodate these new patients.”
Patients receive the drug every two weeks through an hourlong intravenous infusion at hospitals or clinics, after which they must stay a few more hours to see if side effects emerge. The medicine carries risks of potentially serious complications, including brain swelling and tiny hemorrhages, but has also given hope to millions affected by the memory-ravaging disease.
Biogen and Eisai hope regulators will eventually approve an injectable form of Leqembi, which demonstrated encouraging preliminary results in a clinical trial in October and would be more convenient for patients.
The Food and Drug Administration gave full approval to Leqembi on July 6. It was the first time regulators had cleared a drug that medical experts agreed modestly slowed cognitive decline in people with early Alzheimer’s.
After the closely watched decision by the FDA, Medicare administrators swiftly indicated the federal government would cover the costs of the medicine for enrollees who met the insurer’s criteria: They must be diagnosed with mild Alzheimer’s and have documented evidence of beta-amyloid, which forms plaques in the brains of patients.
On Tuesday, Biogen also reported that fourth-quarter revenue and profit declined from a year ago, as the firm recorded charges stemming from its abandonment of an earlier controversial Alzheimer’s drug, Aduhelm. In addition, sales slumped in Biogen’s multiple sclerosis medications, long the firm’s biggest drug category.
Biogen recorded total sales of $2.39 billion for the quarter, down 6 percent from the same period a year ago. For the current year, Biogen expects total revenue to decline by a low- to mid-single digit percentage, while core pharmaceutical revenue is expected to be flat, the firm said in an earnings release.
Myles Minter, an analyst with William Blair, also said Biogen’s fourth-quarter results were lower than expected. Contributing factors included lower than estimated revenue for drugs such as Spinraza, Biogen’s treatment for spinal muscular atrophy, a rare genetic disease that kills more infants than any other inherited disorder.
In a note to investors, Minter said Biogen’s decision to stop marketing Aduhelm was a “prudent move to preserve capital and focus on Leqembi and the Alzheimer’s pipeline.”