Amylyx’s ALS drug sales beat Wall Street expectations in first full quarter

The sales numbers are in for Amylyx’s first full quarter as a commercial-stage biotech, and by and large they beat the Street’s expectations.

Amylyx’s ALS drug Relyvrio pulled in nearly $22 million in the fourth quarter of last year, surpassing analyst estimates and suggesting high demand from patients and advocates’ long-running campaign leading up to last September’s approval. SVB Securities’ Marc Goodman wrote last month the sales consensus was about $4 million.

The vast majority of those sales came from the US, but the drug is also approved in Canada. Shares of Amylyx $AMLX were up nearly 20% in pre-market trading Tuesday.

The higher-than-expected sales come as the company saw physicians prescribe Relyvrio to 1,300 US patients as of Dec. 31. Amylyx estimates there are about 30,000 ALS patients in the country, and co-CEO Josh Cohen said on an earnings call Monday evening that the goal is at least 10,000 patients will be taking the drug at any given time due to the nature of the disease.

James Frates

CFO James Frates added the company hopes to double the number of patients by the end of the first quarter to roughly 2,600. But he cautioned the Relyvrio dosing regimen — one sachet a day for three weeks followed by two per day — makes extrapolating revenue not as easy as it looks.

Last September, the FDA approved Relyvrio after two adcomms and the agency’s reversal over whether it would accept Phase II data and long-term survival analyses as adequate evidence for a green light. The approval proved a huge win for patient advocacy groups who rallied behind the drug after the Phase II data showed a modest, yet statistically significant, impact on patient function.

That campaign has now translated into Amylyx revenue, and execs said they saw encouraging buy-in from doctors and prescribers as well. But the company’s decision to price Relyvrio similarly to edaravone, an older ALS drug approved in 2017, set off a firestorm of criticism from ICER, bioethicists and some patients. Relyvrio’s annual price tag is about $158,000.

The company’s next steps are to continue to up prescription sites, complete the drug’s Phase III study and get Relyvrio approved in Europe. Amylyx announced last month the late-stage study was fully enrolled, and Cohen noted Monday the trial has 664 participants. Topline function data are expected in mid-2024, but survival data may take “another year or more to mature,” he said.

European regulators are also not finished reviewing the application. Amylyx said in an earnings release that “certain major objections remain” and the CHMP is looking to submit another round of questions. Co-CEO Justin Klee remained tight-lipped on Monday’s call, saying the company believes it’s made the “right scientific arguments” for approval but added, “We’ll have to wait and see.”

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