With sales of $103 million in the fourth quarter and $180 million in its first nine months on the market, Madrigal Pharmaceuticals’ metabolic dysfunction-associated steatohepatitis (MASH) treatment Rezdiffra has all the earmarks of a soon-to-be blockbuster.
And other launch statistics, according to the Pennsylvania-based company in its fourth quarter earnings presentation, are pointing to the same conclusion as well.
By the end of last year, more than 11,800 patients were on Rezdiffra. In a conference call on Wednesday, Madrigal CEO Bill Sibold called the progress “an incredible accomplishment in just nine months.”
“Crossing the 10,000-patient threshold is a significant milestone and we continue to steadily add patients at a rate that’s consistent with other top tier specialty medicine launches,” Sibold added.
On the prescriber side, of the top 6,000 gastroenterologists and hepatologists that the company has targeted, 60% had written up an order for Rezdiffra by the end of 2024, compared with 40% at the end of September.
“Both (patient and prescriber) metrics are tracking exceptionally well with other successful blockbuster launches,” Sibold said.
Three months ago, in its third-quarter report, Madrigal pointed out that it achieved a key goal early by gaining 80% coverage of commercially insured lives in the U.S. It’s a milestone the company didn’t expect to reach until the fourth quarter.
“We’re tracking extremely well on all fronts,” Sibold said on Wednesday. “There’s no weakness here on any of them.”
Rezdiffra is a once-daily pill that is the first approved treatment for MASH, previously known as non-alcoholic steatohepatitis (NASH), an underdiagnosed condition which affects an estimated 5% of adults in the U.S.
Investors liked what they saw from Madrigal’s presentation as the company’s share price has increased 17% from the market’s close on Tuesday.
Madrigal is not providing revenue guidance for Rezdiffra sales in the first quarter or for 2025, as chief investor relations officer Tina Ventura said that it “gets a little tricky when you go from Q4 to Q1.” She did say, however, that the company expects analysts' consensus estimates to “narrow and go up a little bit as a result of what we’re seeing so far.”
In a note to investors, analysts at Evercore ISI are projecting Rezdiffra's 2025 sales at $593 million, which top the $520 million consensus.
When asked the likelihood of incretin treatments from Eli Lilly and Novo Nordisk to enter the MASH market soon, Sibold sounded unconcerned. He mentioned that 25% of those on Rezdiffra are already using the diabetes/obesity drugs.
“We expect that with our profile, we continue to be the product of choice in the space,” Sibold said. “We believe that given their profile and our profile, the majority of (patients) are going to end up on Rezdiffra anyways because they’re going to still need to treat the problem that they’re having, which is now a really severe liver disease.”
Madrigal also presented new, two-year data from a phase 3 trial of Rezdiffra, which pointed to positive outcomes that could eventually lead to a label expansion to treat liver cirrhosis.
“These results add to the growing body of evidence supporting Rezdiffra’s potential benefit in this high-risk patient population, for which there is no approved therapy,” Madrigal said.