A new treatment from Amylyx Pharmaceuticals crushed Wall Street's fourth-quarter expectations, sending AMLX stock soaring.
In the first reporting period following its launch, Amylyx's amyotrophic lateral sclerosis drug, Relyvrio, brought in $21.9 million in sales. That was far above even the most bullish expectations for $14 million to $15 million in sales. Analysts polled by FactSet expected only $4.7 million.
Also known as Lou Gehrig's disease, amyotrophic lateral sclerosis, or ALS, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Patients experience worsening muscle weakness over time. The Food and Drug Administration approved Relyvrio in September.
"There has been a ton of noise and confusion heading into the print, but Amylyx has and continues to launch extremely well," Evercore ISI analyst Umer Raffat said in a note to clients. "By my math, Amylyx could perhaps even come fairly close to a break-even in the first quarter (i.e., second quarter of launch)."
On today's stock market, AMLX stock surged 9.4% and closed at 34.10. Shares briefly topped their 50-day moving average, according to MarketSmith.com. Amylyx stock has a strong Relative Strength Rating of 95 out of a best-possible 99, IBD Digital shows. This puts shares in the top 5% of all stocks in terms of 12-month performance.
AMLX Stock: Inventory Buildup Is Key
There were about 1,300 patients on Relyvrio at the end of the fourth quarter, Raffat said.
"Company expects to double that in the first quarter," he said. "I think they will do better than that."
Some $7 million of the fourth-quarter sales are due to two weeks of inventory buildup, he noted. This suggests the ALS treatment could pull in $3.5 million a week. That puts Relyvrio at a run rate of $42 million for the first quarter. But Raffat expects Relyvrio to top that at $60 million.
He has an outperform rating on AMLX stock.
Approval In Europe, Additional Testing
SVB Securities analyst Marc Goodman says a third of commercial policies in the U.S. now reimburse for Relyvrio. The drug also is approved in Canada under the brand name Albrioza, and Amylyx expects a regulatory decision in Europe by midyear with an approval decision in the third quarter.
Meanwhile, Amylyx is still running final-phase testing of the ALS treatment to examine whether it has a benefit on patients' survival long term. Goodman expects that final survival data won't be available until 2025, at the earliest. That gives Relyvrio a strong commercial start while those results are pending.
"We believe (this) should be viewed as positive news to investors as we believe that management will probably wait to see the survival data before determining success of the study (i.e., the product probably has another year to ramp before management determines what to do with the asset)," he said in a note.
He has an outperform rating on AMLX stock.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
