Amylyx’s ALS drug again surpasses Wall Street expectations

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Amylyx Pharmaceuticals has again impressed Wall Street, disclosing Thursday a new earnings report in which product revenue was significantly higher than many analyst forecasts.

The Cambridge, Massachusetts-based biotechnology company said product revenue from January through the end of March totaled $71.4 million, up from the nearly $22 million generated during the final three months of last year.

Amylyx has one product, an ALS medicine sold as Relyvrio in the U.S. and Albrioza in Canada. The company is now profitable less than a year into the drug’s launch, having posted nearly $1.6 million in net income during its latest quarter.

In March, Amylyx executives told investors Relyvrio’s launch was going better than expected. They estimated that more than 1,300 U.S. patients with ALS, or amyotrophic lateral sclerosis, were taking the drug at the end of last year, and that the company was on pace to double this total by the end of the first quarter.

As such, analysts were already anticipating a significant revenue increase ahead of the latest earnings report. Graig Suvannavejh of Mizuho Securities had predicted sales of $61 million, which, according to the investment firm, was above the average analyst estimate of $59 million.

“During the first quarter, we made significant progress on our commercial launches,” Joshua Cohen, an Amylyx co-founder and one of its co-CEOs, said in a statement. “We continue to see strong engagement and interest from physicians and the ALS community and are encouraged that the vast majority of payers who have published formal policy decisions are providing broad access to Relyvrio.”

Amylyx’s share price rose in after-hours trading Thursday.

Margaret Olinger, Amylyx’s chief commercial officer, told investors on a call Thursday that payers covering half of the ALS patients in the U.S. have formal policies for Relyvrio. She said more than 3,000 patients in the U.S. are now on the drug. Amylyx believes Relyvrio can become the new standard of care for ALS, and its long-term aim is to have at least 10,000 people in the country taking the drug at any given time.

In the U.S., Amylyx set Relyvrio’s price at $158,000 for a year’s supply. James Frates, Amylyx’s chief financial officer, said the bulk of first quarter product revenue came from the U.S. and that around 10% of the patients are receiving the drug for free via assistance programs.

The Food and Drug Administration approved Relyvrio based on a trial that enrolled about 140 ALS patients and found those on the drug declined a bit slower functionally than those given placebos. The drug-treated group also lived a median of five months longer than the control arm.

There is currently no cure for ALS, a disease marked by the progressive decay of nerve cells. Even with the few therapies available, patients typically live just two to five years after symptoms start to show. There are an estimated 30,000 or so people with the disease in the U.S.

Amylyx is also trying to show its drug can provide a benefit in other brain and nervous system disorders. The company already sponsored a mid-stage clinical trial evaluating the drug as potential treatment for Alzheimer’s disease, and expects to initiate a new, late-stage study targeting progressive supranuclear palsy later this year.

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Amylyx’s ALS drug again surpasses Wall Street expectations

International Biopharmaceutical Industry