Madrigal Pharmaceuticals (MDGL) Q2 FY26 earnings call: guidance and Q&A

What are the Q3 trends and expectations for net patient adds for the rest of the year? How is endocrinologist uptake progressing, and is it a meaningful growth segment?

Madrigal expects to continue to steadily add patients through Q3 and the rest of the year, having surpassed 50,000 active patients in early July. The company is comfortable with consensus quarterly growth rates for Q3 and Q4. Endocrinologist uptake is still early, about 9 months into the launch focus, but shows promising long-term potential despite requiring time to wire their systems.

“We continue now looking forward to Q3 and beyond to steadily add patients. We've been steadily adding. We're going to continue to steadily add patients through third quarter and through the rest of the year.”

asked by Prakhar Agrawal · answered by William Sibold

What are the drivers of patient growth acceleration in Q2, and what are the expectations for future growth? How is the event rate tracking in the F4c study, and can you provide more clarity on the 2027 readout?

Patient growth is a net result of new starts and discontinuations, with a focus on driving the top of the funnel and maintaining persistency, which is 60-70% at the 1-year mark for well-tolerated orals. Events are accruing in the F4c MAESTRO outcomes trial in line with a 2027 readout, but precision on the exact timing is difficult due to the nature of the event-driven study.

“The good news is we're seeing events accrue in the trial. However, as we said in the past, this isn't like, for example, a cardiovascular outcome study where you have a large number of target events. So in this case, precision is very difficult. And when we can be more precise, we'll provide an update at that point. But right now, we're tracking to 2027, as we said.”

asked by Eliana Merle · answered by David Soergel

Can you clarify gross-to-net and inventory dynamics for the rest of 2026? What is Europe's contribution to revenues and patients, especially with the early access program in France?

Gross-to-net is expected to remain in the mid-to-high 30s for FY26, with no significant changes in inventory dynamics. Europe's contribution is negligible for the quarter and year due to challenged reimbursement, particularly in the context of Most Favored Nation (MFN) policies and ongoing uncertainty about policy changes. Madrigal is engaging with governments for a long-term solution.

“Reimbursement is challenged. You have to remember, we're in an MFN context here, where there is still uncertainty about where that all lands. And I think we're going to be in a period in the next 12, 18 months where things are still settling down.”

asked by Thomas Smith · answered by William Sibold

Can you confirm the 92-event threshold for the F4c trial, or is there a possibility of boosting powering? How does the natural history of F4c event accumulation compare to linear cardiac outcome studies?

Madrigal has not confirmed a specific event threshold, stating that previously published numbers are in the ballpark. Events are accruing in line with the projected 2027 completion date. The company acknowledges that F4c events may accelerate over time as patients progress, but the trial design has effectively enriched the population for events.

“I think the good news is, like I said, we're seeing events accrue. They're in line with our projected completion date in 2027. So when we can be more precise, we'll provide more precision.”

asked by Ritu Baral · answered by David Soergel

When will the Phase II for the Arrowhead asset begin? Is it reasonable to expect data from the oral GLP-1 SAD study next year?

The oral GLP-1 (MGL-2086) SAD study initiated in June and will run through this year, with results informing a Phase II study expected to start in 2027. Similarly, a drug-drug interaction study for the DGAT-2 inhibitor (Ervogastat) will precede its Phase II initiation in 2027, and the PNPLA3 siRNA (Arrowhead asset) Phase II is also estimated for 2027 after regulatory discussions.

“So specifically for the oral GLP-1, as you recall, we're developing the oral GLP-1 ultimately in combination with resmetirom to dial in a little bit of weight loss to potentiate resmetirom's efficacy. So as you pointed out, we started our SAD last month. And we'll be running the SAD in the math sort of through this year is our plan. And the data from that trial will then inform the Phase II study, which after we talk to health authorities would start in 2027.”

asked by Andy Chen · answered by David Soergel

How do you view the potential impact of a competitor like lanifibranor, if successful, on Rezdiffra? Can you elaborate on the impact of the recently issued patents?

Madrigal believes the MASH market is large enough for multiple products, but Rezdiffra has a superior profile. Lanifibranor's association with weight gain and edema makes it less attractive, with market research indicating 80% of prescribers would not use it. The new patents reinforce the existing 2045 F2/F3 protection and include a new F4c use patent, strengthening the franchise's long-term IP.

“The patents that we announced just, I guess, this month was that we secured [indiscernible] patents, and those cover important safety information in our label. So generics have to include that type of language in their label, so them trying to do a single label really makes it challenging for them.”

asked by Kripa Devarakonda · answered by William Sibold