Amylyx Pharmaceuticals impressed Wall Street on Monday with an earnings report that showed the company’s recently approved ALS drug is off to a strong start.
In its first full quarter on the U.S. market, the drug, known as Relyvrio, generated just shy of $22 million. That figure is above analyst forecasts from a month ago, which, according to a note from SVB Securities analyst Marc Goodman, had total Relyvrio sales hovering around $4 million.
Amylyx executives said the results were due in large part to the company’s ability to get buy-in from doctors and insurance providers. “We are proud of the progress we’ve made to date, and encouraged by the early success of our commercial launch,” Justin Klee, one of Amylyx’s co-founders and co-CEOs, said during a Monday afternoon call with investors.
Shares of Amylyx rose by more than 20% in after-hours trading, adding more than $400 million to the company’s market value if those gains hold into Tuesday.
The Food and Drug Administration approved Relyvrio in late September based on data from a clinical trial of about 140 patients with ALS, or amyotrophic lateral sclerosis. The trial showed that participants given Amylyx’s drug had somewhat slower functional decline compared to those on placebo, and appeared to live about five months longer.
While still considered modest by some experts, the study’s findings made Relyvrio a closely watched and sought-after option for many ALS patients and healthcare providers. Almost every experimental treatment for the disease has failed. And, to date, the FDA has approved just two other medicines specifically for ALS, both of which have limited benefit on either function or survival.
A progressive disorder marked by the death of nerve cells, ALS eventually causes patients to lose their ability to perform essential functions like walk, talk, eat and breathe. Typically, the disease is fatal two to five years after symptoms first show.
Since its approval, doctors as well as analysts have been keenly interested in whether insurance companies will pay for Relyvrio, which Amylyx priced at $158,000 for a year’s supply.
Multiple times in the past, insurers have balked at expensive medications for rare disorders like ALS. Indeed, Cigna, one of the nation’s largest health insurance providers, made the controversial decision earlier this year to change its policy and severely restrict which of its customers would be able to access Relyvrio.
“Right now, there is not enough clear clinical evidence to support Relyvrio’s effectiveness so it is not currently covered on our standard formularies,” Cigna said last month.
Yet, Amylyx has argued that policy is an outlier. Executives said during the call Monday that U.S. insurers representing approximately one-third of the country’s ALS patients have published formal coverage policies for Relyvrio, with the “vast majority” providing broad access.
Amylyx noted, too, that at this point in the launch, more patients than expected have gained access to Relyvrio through their insurance. The company estimates over 1,300 U.S. patients were taking its drug at the end of last year, and that it’s on pace to double that total by the end of March.
Ultimately, Amylyx executives hope to have at least 10,000 ALS patients in the U.S. on Relyvrio at any given time. “There’s still significant room for growth,” said Margaret Olinger, the company’s chief commercial officer.
In a note to clients, Evercore ISI analyst Umer Raffat wrote that first quarter Relyvrio sales could reach $60 million.
Moving forward, Amylyx aims to widen the pool of doctors prescribing its drug. Roughly half of all the Relyvrio prescriptions written last quarter came from 70 or so healthcare providers, most of whom work at large ALS treatment centers. But by Amylyx’s estimates, the U.S. has about 2,700 potential prescribers of ALS therapies.
“As we expand our education efforts, we have an opportunity to see broader and deeper uptake among the key providers,” Olinger said.
In Canada, which has about 3,000 patients living with ALS, Amylyx says it has negotiated agreements with all of the largest private insurers. As for the country’s public insurance program, the company continues to work with officials but notes the reimbursement process can take up to a year. Canadian regulators first approved Albrioza last June.
European regulators, meanwhile, are currently reviewing a marketing authorization application for Amylyx’s drug.