Can you discuss the breadth of prescribing across gastroenterologists, hepatologists, and endocrinologists, and explain the Q1 patient add dynamics, particularly regarding insurance deductible resets?

The company has over 10,000 prescribers. Gastroenterologists account for the majority due to their higher numbers. Hepatologists were early adopters. Endocrinologists are a growing segment, comparable to where gastroenterologists were 2.5 years ago. Q1 patient adds reflect a typical Q1 effect due to insurance changes, but momentum is strong into Q2. “So the Q1 adds, again, it falls into our steadily adding patients, and it is a Q1 effect. That's really it. I mean when you think about the Q1 effect, the Q1 effect applies to virtually 100% of your patients on therapy.”

How has the patient mix, specifically GLP-1 combo use, evolved, and what is the F2/F3 split among Rezdiffra patients?

Around 25%+ of Rezdiffra patients are concomitantly on a GLP-1, and over 50% have been previously exposed to a GLP-1. The F2/F3 split remains consistently about 50-50, as prescribers treat based on risk factors rather than waiting for progression. “We still continue to see 25-plus percent of patients that are on Rezdiffra also on a GLP-1 and over 50% have been previously exposed.”

Should Madrigal increase spending on disease awareness to drive diagnostic growth? How does SG&A spend balance with profitability goals, and what are the full-year estimates given gross-to-net changes?

The market has already seen significant diagnostic growth (50% in 2 years) due to Rezdiffra's approval and increased awareness. The company will continue to support the brand with SG&A, expecting an increase in Q2 then steadiness. Gross-to-net is expected to be mid- to high 30s for the rest of 2026. The company is comfortable with current full-year consensus estimates and expects profitability beyond 2026, but not in 2026 itself. “The full year, yes. We are good with the consensus that you mentioned for the full year. That sounds good, and we're also looking good for with the same analogy. So we seem to be right on track and feel good about the rest of the year.”

MDGL

Madrigal Pharmaceuticals (MDGL) Q1 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q1 FY26)· Health Care· May 6, 2026

Source: earnings call transcript

Executive summary

Madrigal Pharmaceuticals Q1 FY26 — Rezdiffra Blockbuster Status & Pipeline Expansion

Madrigal Pharmaceuticals reported a strong start to FY26, with Rezdiffra achieving blockbuster status and demonstrating significant patient growth. The company is strategically expanding its pipeline through targeted business development, aiming to solidify its leadership in the rapidly growing MASH market. While profitability is not expected in the current fiscal year due to investments, management anticipates it will be inevitable beyond 2026.

Highlights

Rezdiffra achieved blockbuster status, generating over $1.1 billion in net sales in the last 12 months.
First quarter 2026 net sales for Rezdiffra were $311 million, representing year-over-year growth of 127%.
The company ended Q1 FY26 with more than 42,250 active patients on Rezdiffra, a 2.5x increase compared to Q1 FY25.
The U.S. addressable MASH market expanded nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025.
Gross to net discount is now expected to be in the mid- to high 30s for the rest of 2026, better than anticipated.

Concerns

Net loss for the first quarter of 2026 was $94.4 million, inclusive of $54.3 million in one-time upfront business development expenses.
The company does not expect to be profitable in 2026, with Q2 SG&A expenses anticipated to be higher due to marketing timing.

Guidance & targets

Category	Target	Timeline	Confidence
Gross to net discount	mid- to high 30s medium materiality	Rest of FY26	High
Full year R&D expenses	roughly the same as 2025 medium materiality	Full Year FY26	High
Full year SG&A expenses	increase compared to 2025 medium materiality	Full Year FY26	High
Profitability	not profitable in 2026 high materiality	Full Year FY26	High
Profitability	inevitable beyond 2026 high materiality	Beyond FY26	High
Maestro MASH outcomes trial readout	2027 high materiality	CY27	High
Rezdiffra F2/F3 study data	2028 high materiality	CY28	High
D2 inhibitor drug-drug interaction study	on track to begin in the fourth quarter of this year medium materiality	Q4 · FY26	High
D2 inhibitor Phase II combination study	initiate in 2027 medium materiality	CY27	High
Oral GLP-1 Phase I single ascending dose study	initiate later this quarter medium materiality	Q2 · FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
F2/F3 MASH Market The U.S. addressable market for F2/F3 MASH patients seen by target specialists grew nearly 50% from end 2023 to end 2025. Diagnosis and Rezdiffra penetration rates remain low, indicating significant growth potential. Addressable patients (end 2025): 460,000Addressable patients (end 2023): 315,000Diagnosis rate: just over 10%Rezdiffra penetration: just under 10% of 460,000 addressable patients	—	—	—	—
F4C MASH Market This represents an untapped market with no approved therapies, offering a significant opportunity to double Rezdiffra's potential. Patients under specialist care in U.S.: 245,000	—	—	—	—

MDGL operating KPIs by quarter

MDGL operating KPIs stated on its earnings calls, by fiscal quarter
KPI	This call Mar 2026 Q1 FY26	Jun 2026 Q2 FY26	Change vs prior quarter
Patients Rezdiffra	42.25K+ We ended the first quarter with more than 42,250 active patients on Rezdiffra. Source: earnings call transcript	49K+ That's why we've steadily added patients ending the second quarter with more than 49,000 active patients on Rezdiffra, more than double a year ago. Source: earnings call transcript	—

Operating figures the company stated on at least two of the calls shown, checked against each call's transcript. Click a figure to read the sentence. A dash means it was not stated that quarter.

Deals & partnerships

Arrowhead In-licensing of ARO-PNPLA3, a clinical stage siRNA asset. $25M upfront payment

The asset targets a mutation in the PNPLA3 gene, a genetically validated driver of disease in a meaningful subset of patients. It has completed Phase I studies and demonstrated significant liver fat reduction.

Risks & headwinds

Q1 effect on patient adds Q1 FY26

Lower patient adds compared to some recent quarters

Mitigation:This is a typical Q1 effect due to benefit plan changes and insurance reverifications; momentum is strong into Q2.

Net loss due to business development expenses Q1 FY26

$94.4M net loss in Q1 FY26, inclusive of $54.3M one-time upfront BD expenses

Mitigation:These are strategic investments to build the pipeline; profitability is expected beyond 2026.

Higher SG&A expenses Q2 FY26

Q2 FY26 SG&A expenses expected to be higher

Mitigation:Due to timing of certain marketing expenses, including DTC, then steadies for the rest of the year. Part of supporting the Rezdiffra launch and long-term growth.

Unprofitability in current fiscal year FY26

Not profitable in 2026

Mitigation:Company is focused on supporting top-line growth and building its pipeline; profitability is believed to be inevitable beyond 2026.

What to watch in Q2 FY26

Rezdiffra Q2 patient adds and net sales growth

Q2 FY26

Current 42,250 active patients (end Q1 FY26), $311.3M net sales (Q1 FY26)

Target Continued steady patient adds and robust net sales growth

Why it matters

To confirm the strong momentum reported for Q2 and assess the impact of the typical Q1 effect on patient growth.

And importantly, we are seeing that momentum carried into the second quarter. [...] For the rest of 2026, we expect to steadily add patients and generate robust net sales growth.

Find out whether MDGL delivers this. Inve re-checks your case every morning.

Q&A highlights

What are the Q2 trends for Rezdiffra patient adds, and what impact is Wegovy having on Rezdiffra's market performance?

Q2 is off to a strong start with steady patient adds. Wegovy (GLP-1s) has not negatively impacted Rezdiffra; most patients are already on GLP-1s when they present with F2-F3 MASH. April saw the best NBRx month since launch, indicating continued strong momentum.

“As we exit April, it's been our best NBRx month since launch. So we're really excited about the rest of the year. We'll be steadily adding patients, just as we've said from [indiscernible]”

asked by Prakhar Agrawal · answered by William Sibold

2 min read 5 chapters

Detailed narrative

Rezdiffra Commercial Performance and Market Expansion

Rezdiffra has achieved blockbuster status with over $1.1 billion in net sales in the last 12 months, driven by strong Q1 FY26 sales of $311 million, a 127% year-over-year increase. The company ended Q1 with over 42,250 active patients, representing a 2.5x increase from Q1 FY25.

The U.S. addressable MASH market has grown nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025, with Rezdiffra penetration still under 10% and diagnosis rates just over 10%, indicating substantial future growth opportunity.

Strategic Pipeline Development and R&D Goals

Madrigal's R&D strategy focuses on delivering an industry-leading pipeline in MASH, with Rezdiffra as the foundational therapy. The strategy includes four key goals: delivering outcomes data and full approval for Rezdiffra across F2-F4C, advancing complementary mechanisms for combination therapies, remaining modality-agnostic (e.g., siRNA assets), and leveraging expertise for efficient clinical trials.

The company has assembled a pipeline of over 10 programs for under $300 million, demonstrating capital efficiency.

F4C Opportunity and Maestro Outcomes Trial

The F4C (well-compensated MASH cirrhosis) market represents a significant untapped opportunity, with approximately 245,000 patients under specialist care in the U.S. and no approved therapies. This indication could double Rezdiffra's market opportunity. The Maestro MASH outcomes trial in F4C is event-driven and expected to read out in 2027, with confidence informed by 2-year open-label data from the Maestro NAFLD-1 trial, which showed 65% of patients with clinically significant portal hypertension (CSPH) at baseline shifted into lower-risk categories by year 2.

ARO-PNPLA3 In-licensing and Combination Strategy

Madrigal in-licensed ARO-PNPLA3, a clinical-stage siRNA from Arrowhead, targeting the PNPLA3 gene mutation. This mutation is prevalent in approximately 30% of F2-F3 MASH patients, particularly Hispanic patients, and is associated with a twofold higher risk of liver-related events. Phase I data showed a single dose reduced liver fat by up to 46% at 12 weeks.

The strategy is to combine Rezdiffra with targeted agents like ARO-PNPLA3 to improve efficacy in specific patient subsets or broadly across the population.

Financial Performance and Outlook

First quarter 2026 net sales were $311.3 million. Operating expenses included $34 million in noncash stock-based compensation. R&D expenses increased to $108.7 million (from $44.2 million YoY), primarily due to $54.3 million in one-time upfront business development expenses. SG&A expenses rose to $268.5 million (from $167.9 million YoY) due to commercial activities and endocrinology field force expansion.

The company ended Q1 with $817.9 million in cash and equivalents, down from $988.6 million at year-end 2025, reflecting BD payments and API purchases. Madrigal expects to be unprofitable in 2026 but anticipates profitability beyond that.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.