In its first full quarter on the market, Madrigal Pharmaceuticals’ Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), achieved sales of $14.6 million. The company also reported that by the end of the second quarter, there were 2,000 patients on Rezdiffra, in a promising launch for the liver disease drug.
The sales figure nearly tripled the consensus expectations of analysts, but Madrigal's share price fell by 13% on Wednesday, as the company anticipates headwinds into the next few quarters.
While Rezdiffra is "strong outta the gates," according to ISI Evercore, the analysts expect "some bumpiness for 2024," as "net pricing comes down compared to lower than anticipated usage of copay assistance in 2Q."
The analysts noted Madrigal's reluctance to reveal how many new patient start forms have been submitted. The company's spending also was higher than anticipated and will only increase with an expected launch next year in Europe.
As for that launch, which is expected in the middle of next year, CEO Bill Sibold said during a conference call that Madrigal is “fully committed” to commercializing the drug on its own and is not seeking a local partner.
“I’ve commercialized multiple products in Europe. We have a team that has done that as well. We feel like we’re extremely well positioned to do so,” said Sibold, who took over at Madrigal 11 months ago after serving 12 years at Sanofi.
Sibold also said he anticipates uptake in Europe will progress quicker than it has in the U.S., primarily because there is more certainty that it will be approved and physicians are already planning as such.
“There’s real excitement in Europe for this drug,” Sibold said. “In the U.S., because there’s been so many failures (in MASH) before, there was this question: Will Rezdiffra get approved? And a lot of the physicians didn’t take action until post approval.”
Aside from sales, Madrigal’s metrics indicate the launch is going well. The company is targeting 6,000 hepatologists and gastroenterologists, with 20% of them having written a prescription for Rezdiffra during the second quarter, which is “aligned with the penetration level often seen in launches of blockbuster medicines,” Sibold said.
Additionally, by the end of the second quarter, more than 50% of commercial lives had coverage in place, which is up from 30% at the end of the first quarter. The company plans to have 80% of commercial lives covered by the end of the year. Medicaid coverage is in place in all 50 states.
Madrigal also plans to expand Rezdiffra’s label to treat patients with a more advanced form of MASH, compensated cirrhosis, which would double its eligible population. A phase 3 trial is event-driven and will likely not read out until 2026 or 2027.
Madrigal is in a strong position financially with its launch as it ended the second quarter with $1.1 billion on its balance sheet.
Sibold declined to answer a question on the call about the peak sales potential of Rezdiffra. But he did emphasize Madrigal’s edge against potential competitors, including Eli Lilly’s GLP-1/GIP dual-action drug tirzepatide, which posted strong results from a phase 2 trial of MASH patients two months ago.
“MASH overall, we’re talking about billions,” Sibold said. “We don’t think anyone is as good as us, and none of them are pills. You ask patients, especially these patients, they have a lot of other stuff that they have to take. A pill is a lot easier add than if you’re going to add another injectable.”