Blockbuster Net Sales and Strong Quarterly Revenue
Trailing 12-month net sales for Rezdiffra exceeded $1.1 billion. First quarter 2026 net sales were $311.3 million, representing year-over-year growth of 127%.
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The call conveyed a strongly positive commercial and scientific momentum: Rezdiffra has achieved blockbuster status with rapid patient growth, a materially expanding addressable market, and an increasingly diverse pipeline (including a promising siRNA asset). These positives are balanced by elevated operating expenses, one‑time business development costs, a material gross‑to‑net discount, and near‑term non‑profitability with cash modestly reduced by strategic uses. Management emphasized durable long‑term opportunity, upcoming outcomes milestones (2027–2028), and disciplined, data‑driven pipeline advancement.
The company reiterated growth and financial guidance for 2026: Q1 net sales were $311.3M (+127% YoY) and trailing 12‑month net sales exceed $1.1B, with >42,250 active patients on therapy at quarter end (2.5x YoY) and the U.S. addressable F2/F3 market having grown ~50% from 315,000 (end‑2023) to 460,000 (end‑2025) while diagnosis is just over 10% and Rezdiffra penetration is just under 10%; management expects to steadily add patients through 2026, F4C represents ~245,000 specialists’ patients and the event‑driven outcomes readout is expected in 2027 (F2/F3 histology readout in 2028); financials include Q1 cost of sales $26.8M, R&D $108.7M (including $54.3M one‑time BD expense), SG&A $268.5M, $34M noncash stock‑based comp, and a Q1 net loss of $94.4M; they expect gross‑to‑net in the mid‑ to‑high‑30s% for the rest of 2026, full‑year R&D roughly flat with 2025, higher full‑year SG&A (with a Q2 spike tied to DTC/timing), a Q2 recording of the $25M ARO‑PNPLA3 upfront, ending Q1 cash of $817.9M, and do not expect profitability in 2026 (though they say profitability is “inevitable” thereafter).
Trailing 12-month net sales for Rezdiffra exceeded $1.1 billion. First quarter 2026 net sales were $311.3 million, representing year-over-year growth of 127%.
Active patients on Rezdiffra exceeded 42,250 at quarter end, a ~2.5x increase year-over-year. U.S. addressable diagnosed F2/F3 population expanded from ~315,000 (end 2023) to ~460,000 (end 2025), an increase of ~46% (described as nearly 50%).
Pipeline now includes more than 10 programs and the in‑license of ARO‑PNPLA3 (clinical‑stage siRNA). ARO‑PNPLA3 Phase I showed up to a 46% reduction in liver fat at 12 weeks (single dose) in the genetically defined PNPLA3 homozygote population (~30% of F2–F3 patients are homozygous carriers).
Rezdiffra is running an event‑driven F4C outcomes trial expected to read out in 2027 and a F2/F3 histology‑driven Phase III with data expected in 2028. Open‑label data showed 65% of patients with clinically significant portal hypertension (CSPH) shifted into lower‑risk categories by year 2, supporting the F4C program.
More than 10,000 prescribers; established first‑line payer access; strong real‑world feedback across multiple endpoints (liver stiffness, MRI‑PDFF, enzymes, LDL‑C, Lp(a)). Company reported best MBRx week last quarter and best NBRx month since launch in April; >40 Rezdiffra abstracts presented at meetings.
Ending cash, cash equivalents, restricted cash and marketable securities of $817.9 million, providing runway to support launch, pipeline advancement and ongoing business development.
Good morning, and thank you for standing by. Welcome to Madrigal Pharmaceuticals First Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.
Thanks, Brilla. Good morning, everyone, and thank you for joining us to discuss Madrigal's First Quarter 2026 earnings. We issued a press release this morning and put the slide deck to accompany this webcast on the Investor Relations section of our website. On the call with me today is Bill Sibold, Chief Executive Officer; Dave Sergel, Chief Medical Officer; and Mardi Dier, Chief Financial Officer. They will provide prepared remarks followed by Q&A. Please note on Slide 2. We will be making certain forward-looking statements today. We refer you to our SEC filings for a discussion of the risks that may cause actual results to differ from the forward-looking statements.
With that, I will now turn the call over to Bill on Slide 3.
Thanks, Tina. Good morning, and thanks for joining us. 2026 is off to a terrific start. We've made impressive progress towards our strategic growth priorities to maximize the value of Rezdiffra and build our pipeline. Rezdiffra has achieved blockbuster status generating more than $1.1 billion in net sales in the last 12 months. That's a $1 billion run rate in a market that's still in its infancy. Penetration is low, the diagnosis rate is low, unmet need is high and the market is expanding at a double-digit pace. When you put those fundamentals togeth...
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