With $1.1 billion cash on Madrigal Pharmaceuticals’ balance sheet, CEO Bill Sibold believes the company can “fully resource” the launch of Rezdiffra, the first FDA-approved therapy for fatty liver disease.
Despite an FDA approval in March for metabolic dysfunction-associated steatohepatitis (MASH) with moderate or severe liver fibrosis, Rezdiffra did not produce revenue for Madrigal in the first quarter. Still, the drug has sparked “remarkable interest” among doctors, as Madrigal’s sales reps are getting access to physicians who typically don’t see reps, Sibold said Tuesday on the company’s first-quarter earnings conference call.
Sibold himself has met with more than 100 prescribers, and the feedback around Rezdiffra’s profile has been “overwhelmingly positive,” he added.
Madrigal’s market research shows that 90% of physicians who are familiar with Rezdiffra believe it offers high clinical utility, with most citing the drug’s efficacy, the lack of biopsy requirements and simple dosing as the top reasons for their enthusiasm. In Madrigal’s most recent survey, 78% of respondents said they have prescribed or plan to prescribe Rezdiffra in the next one or two months.
Madrigal is now focused on “wiring the system” to support what’s expected to be a blockbuster launch, Sibold said
“With a first-in-disease medicine, it’s about spending the necessary time upfront with physicians and their office staff to create the care pathways for patients,” he explained. “This work builds the strong foundation needed to support the future volume of prescriptions we expect.”
Madrigal’s sales team has reached more than 80% of its top physician targets, according to the company. The team is primarily targeting about 6,000 high-volume MASH-treating physicians out of a pool of 14,000 doctors. So far, 75% of Rezdiffra prescriptions have been from top targets, although the company didn’t give the specific number of scripts written to date. It plans to share more details on the number of patients in its next quarterly report. Overall, the company is targeting 315,000 MASH patients who are actively being treated by doctors in the U.S.
As payers approve coverage, and once physician offices become familiar with the treatment process and reimbursement requirements, the volume and pace of prescriptions will increase, Sibold said. Further, anticipated new treatment guidelines from the American Association for the Study of Liver Diseases could also facilitate Rezdiffra usage.
Commercial coverage for Rezdiffra is currently in place for 30% of U.S. lives, tracking in line with Madrigal’s goal to reach 80% by the year’s end, according to Sibold.
At this point, most patients are being processed under medical exceptions, which allow for coverage before formal policies are put in place. Madrigal expects large plans to begin covering Rezdiffra in the months ahead as they conduct internal evaluation processes and determine any potential prior authorization criteria. In early coverage decisions, the criteria Madrigal has seen are “generally aligned with” Rezdiffra’s label, Sibold said.
In one launch setback, the Veterans Affairs Department has implemented an extra hurdle, requiring a diagnosis from a liver biopsy for a patient to be eligible for Rezdiffra, according to an analyst on Tuesday’s call.
VA’s decision won’t have a large impact on the launch because the agency only covers a single-digit percentage of Rezdiffra’s current target patient population, Madrigal CFO Mardi Dier said on the call.
Sibold argued that the VA policy won’t affect commercial payers, who will make independent decisions. The CEO attributed the VA restriction to the agency's predetermined annual budget and said the company will push to change the policy next year.
“We think that certainly the guidelines, and the medical community, and certainly the patient community is on our side to have that happen," he said.
Rezdiffra came to the market as the first drug to have shown a statistically significant advantage over a placebo against liver scarring, or fibrosis. In a phase 3 trial, roughly 25% of patients on two different Rezdiffra doses enjoyed fibrosis improvement of at least one stage, with no worsening of fatty liver disease, after a year of treatment. The number was about 14% for placebo.
Other companies are also eying MASH, traditionally known as nonalcoholic steatohepatitis (NASH), including the GLP-1 class of meds for diabetes and weight loss. When asked by an analyst about the possible impact of Novo Nordisk’s popular Wegovy showing an anti-fibrosis benefit in an upcoming phase 3 readout, Sibold argued that “there’s a very compelling reason for patients to be on Rezdiffra.”
“It’s every drugmaker’s dream to have a once-a-day pill for a serious disease,” Sibold said of Rezdiffra. “I’ll take that profile, and we will compete against anyone, especially since we’re at the beginning of the market. We’re not talking about a zero-sum game here where market shares are all locked in place […] We’re hopeful that there’s going to be other products in NASH because it helps to grow the market.”
Madrigal also expects to reinforce Rezdiffra’s clinical profile—and potentially convert the current accelerated approval to a full nod—with patient outcomes data from the MAESTRO-NASH trial. That dataset is expected in 2028, and Sibold noted it will still be years ahead of other outcomes readouts from competitors.