Madrigal Pharmaceuticals is “making great progress” on the rollout of its NASH drug Rezdiffra, executives said less than a month post-launch.
Rezdiffra was approved in March as the first treatment for NASH, a debilitating liver disease now also referred to as metabolic dysfunction-associated steatohepatitis, or MASH. Madrigal CEO Bill Sibold told investors on Tuesday that it’s too early to disclose prescription data, as the first shipments went out in April. But, he added, “What we’ve seen to date is really encouraging.”
“I’m really encouraged by the early progress so far and even more confident today in the blockbuster potential of this medicine,” Sibold said.
Jefferies analysts on Tuesday predicted Rezdiffra sales could reach $3.4 billion across the US and Europe.
Sibold, who led Sanofi’s specialty drug business before joining Madrigal, has repeatedly said that Rezdiffra’s first year on the market will be about “wiring the system.” He touted early progress with insurers on Tuesday, with coverage in place for 30% of commercial patients. By the end of the year, Sibold hopes to achieve coverage for 80% of commercial patients. He expects “many of the larger plans” to begin coverage in the coming months.
“Our reimbursement team continues to have active dialogue with payers with a focus on the comprehensive Rezdiffra clinical dataset and the use of non-invasive tests or NITs as a means for patient identification and monitoring,” Sibold said.
While the US Department of Veterans Affairs has listed a liver biopsy among its criteria for use for Rezdiffra released last month, Sibold said Madrigal is “working with the VA to have that corrected.”
When asked by an analyst about whether the VA’s criteria could impact other coverage decisions, Sibold said “these payers all make their own independent decisions.”
Mardi DierMadrigal recorded $81 million in selling, general and administrative expenses in the first quarter of 2024, up from $60 million in the same period last year, driven by its commercial scale-up ahead of Rezdiffra’s launch. Sibold said the company’s field teams are educating providers on NASH and Rezdiffra, adding that he received “overwhelmingly positive” feedback in his interactions with more than 100 prescribers.
“We are fully resourced to support a successful multiyear launch of Rezdiffra,” said CFO Mardi Dier, who joined Madrigal earlier this year.