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Investor releaseQuarter not tagged2026-07-31Madrigal Pharmaceuticals (MDGL) Beat Earnings Estimates, Is It Still Below Fair Value?
Simply Wall St.
Madrigal Pharmaceuticals (MDGL) Beat Earnings Estimates, Is It Still Below Fair Value?
Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Madrigal Pharmaceuticals (MDGL) drew attention after its second quarter 2026 earnings release, which highlighted Rezdiffra sales growth, stronger patient uptake, a smaller than expected quarterly loss, and revenue ahead of market estimates. See our latest analysis for Madrigal Pharmaceuticals. Despite solid interest in Rezdiffra and pipeline updates, Madrigal Pharmaceuticals’ share price has slipped recently, with the 30 day share price return down 8.16% and the year to date share price return down 16.97%, while the 1 year total shareholder return is 63.01%. If you are thinking beyond a single MASH focused stock, this could be a good moment to broaden your search to other healthcare opportunities through 41 healthcare AI stocks The recent pullback leaves Madrigal Pharmaceuticals trading below some valuation models, even after a strong run. Is more of Rezdiffra’s potential already reflected in the price, or does the current setup still point to meaningful upside ahead? The most followed valuation narrative for Madrigal Pharmaceuticals sets a fair value well above the last close of $493.11, framing the recent pullback as a discount to that estimate and anchoring expectations firmly on Rezdiffra’s long term role in MASH. Read the complete narrative. Want to see what sits behind that confidence in Madrigal Pharmaceuticals? The core of this narrative is an aggressive ramp in revenue, a sharp swing to strong margins, and a future earnings base that needs to support a higher valuation multiple than many biotech peers. Result: Fair Value of $678.71 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this Madrigal Pharmaceuticals narrative still hinges on Rezdiffra staying on track, and on competition or reimbursement pushback not biting harder than expected. Find out about the key risks to this Madrigal Pharmaceuticals narrative. With sentiment around Madrigal Pharmaceuticals clearly split, this is a good time to move quickly and weigh the facts yourself. To understand what investors see as the brighter spots in the story, start with the 3 key rewards. If you stop with Madrigal Pharmaceuticals, you might miss other stocks that fit your style. Let the Simply Wall St Screener s…Read full documentShow less
Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Madrigal Pharmaceuticals (MDGL) drew attention after its second quarter 2026 earnings release, which highlighted Rezdiffra sales growth, stronger patient uptake, a smaller than expected quarterly loss, and revenue ahead of market estimates. See our latest analysis for Madrigal Pharmaceuticals. Despite solid interest in Rezdiffra and pipeline updates, Madrigal Pharmaceuticals’ share price has slipped recently, with the 30 day share price return down 8.16% and the year to date share price return down 16.97%, while the 1 year total shareholder return is 63.01%. If you are thinking beyond a single MASH focused stock, this could be a good moment to broaden your search to other healthcare opportunities through 41 healthcare AI stocks The recent pullback leaves Madrigal Pharmaceuticals trading below some valuation models, even after a strong run. Is more of Rezdiffra’s potential already reflected in the price, or does the current setup still point to meaningful upside ahead? The most followed valuation narrative for Madrigal Pharmaceuticals sets a fair value well above the last close of $493.11, framing the recent pullback as a discount to that estimate and anchoring expectations firmly on Rezdiffra’s long term role in MASH. Read the complete narrative. Want to see what sits behind that confidence in Madrigal Pharmaceuticals? The core of this narrative is an aggressive ramp in revenue, a sharp swing to strong margins, and a future earnings base that needs to support a higher valuation multiple than many biotech peers. Result: Fair Value of $678.71 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this Madrigal Pharmaceuticals narrative still hinges on Rezdiffra staying on track, and on competition or reimbursement pushback not biting harder than expected. Find out about the key risks to this Madrigal Pharmaceuticals narrative. With sentiment around Madrigal Pharmaceuticals clearly split, this is a good time to move quickly and weigh the facts yourself. To understand what investors see as the brighter spots in the story, start with the 3 key rewards. If you stop with Madrigal Pharmaceuticals, you might miss other stocks that fit your style. Let the Simply Wall St Screener surface ideas that match your checklist. Target potential mispriced opportunities by reviewing companies flagged in our 56 high quality undervalued stocks. Strengthen your focus on financial resilience by checking stocks in the solid balance sheet and fundamentals stocks screener (46 results). Spot future standouts early by scanning the screener containing 20 high quality undiscovered gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include MDGL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-07-30Madrigal Pharmaceuticals Q2 Earnings Call Highlights
MarketBeat
Madrigal Pharmaceuticals Q2 Earnings Call Highlights
Interested in Madrigal Pharmaceuticals, Inc.? Here are five stocks we like better. Rezdiffra sales rose 71% year over year to $364.3 million in Q2 2026, with nearly $1.3 billion in trailing 12-month sales and more than 49,000 active patients. Madrigal said demand remains strong, while the diagnosed U.S. specialist-addressable market continues to expand. Madrigal reported a $57.9 million quarterly net loss, pressured by a $25 million Arrowhead licensing payment and higher commercial spending. Cash, restricted cash and marketable securities declined to $838.9 million from $988.6 million at year-end 2025. The company expects its F4C cirrhosis Phase III trial to read out in 2027 and is advancing additional MASH programs, including MGL-2086, ervogastat and MGL0795 combinations. New Rezdiffra patents could extend protection into the 2040s, with existing F2-F3 protection extending to 2045. MarketBeat Week in Review – 09/08 - 09/12 Madrigal Pharmaceuticals (NASDAQ:MDGL) reported second-quarter 2026 net sales of $364.3 million for Rezdiffra, up 71% from a year earlier, as the company continued to expand the number of patients receiving its treatment for metabolic dysfunction-associated steatohepatitis, or MASH. The company said Rezdiffra had generated nearly $1.3 billion in trailing 12-month net sales and ended the quarter with more than 49,000 active patients, more than double the level reported a year earlier. Madrigal said it surpassed 50,000 active patients earlier in July. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now CoreWeave and Madrigal's Insider Trades Flash Bullish Signals “Demand for Rezdiffra remains strong,” Chief Executive Officer Bill Sibold said during the company’s earnings call. He said prescriptions continue to be driven primarily by hepatologists and gastroenterologists, while the company is still early in its effort to reach endocrinologists, which began in the fourth quarter of 2025. Madrigal said the U.S. addressable market for diagnosed F2/F3 MASH patients treated by its target specialists grew to approximately 460,000 patients at the end of 2025, compared with 315,000 at the end of 2023. Sibold attributed the expansion to increased disease awareness, diagnosis, referrals to specialists and urgency to treat patients. → 3 Value ETFs to Consider as Growth Stocks Lag Behind Novo Nordisk: A New Boost for GLP-1 Sales on the Horizon The…Read full documentShow less
Interested in Madrigal Pharmaceuticals, Inc.? Here are five stocks we like better. Rezdiffra sales rose 71% year over year to $364.3 million in Q2 2026, with nearly $1.3 billion in trailing 12-month sales and more than 49,000 active patients. Madrigal said demand remains strong, while the diagnosed U.S. specialist-addressable market continues to expand. Madrigal reported a $57.9 million quarterly net loss, pressured by a $25 million Arrowhead licensing payment and higher commercial spending. Cash, restricted cash and marketable securities declined to $838.9 million from $988.6 million at year-end 2025. The company expects its F4C cirrhosis Phase III trial to read out in 2027 and is advancing additional MASH programs, including MGL-2086, ervogastat and MGL0795 combinations. New Rezdiffra patents could extend protection into the 2040s, with existing F2-F3 protection extending to 2045. MarketBeat Week in Review – 09/08 - 09/12 Madrigal Pharmaceuticals (NASDAQ:MDGL) reported second-quarter 2026 net sales of $364.3 million for Rezdiffra, up 71% from a year earlier, as the company continued to expand the number of patients receiving its treatment for metabolic dysfunction-associated steatohepatitis, or MASH. The company said Rezdiffra had generated nearly $1.3 billion in trailing 12-month net sales and ended the quarter with more than 49,000 active patients, more than double the level reported a year earlier. Madrigal said it surpassed 50,000 active patients earlier in July. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now CoreWeave and Madrigal's Insider Trades Flash Bullish Signals “Demand for Rezdiffra remains strong,” Chief Executive Officer Bill Sibold said during the company’s earnings call. He said prescriptions continue to be driven primarily by hepatologists and gastroenterologists, while the company is still early in its effort to reach endocrinologists, which began in the fourth quarter of 2025. Madrigal said the U.S. addressable market for diagnosed F2/F3 MASH patients treated by its target specialists grew to approximately 460,000 patients at the end of 2025, compared with 315,000 at the end of 2023. Sibold attributed the expansion to increased disease awareness, diagnosis, referrals to specialists and urgency to treat patients. → 3 Value ETFs to Consider as Growth Stocks Lag Behind Novo Nordisk: A New Boost for GLP-1 Sales on the Horizon The company said it expects the MASH market to continue growing at a double-digit rate for the foreseeable future. Sibold said Madrigal estimates the market remains at an early stage, with roughly 10% diagnosis and about 10% penetration among diagnosed patients. Chief Financial Officer Mardi Dier said the company was comfortable with consensus quarterly growth rates for the remainder of 2026 and expects continued steady patient additions through the third and fourth quarters. Madrigal maintained its expectation that its full-year gross-to-net discount will remain in the mid- to high-30% range. → 5 AI Stocks Are Pulling Back—Which Growth Catalysts Still Look Strongest? International revenue made a negligible contribution during the quarter, according to Sibold. The company has launched Rezdiffra in Germany, begun an early-access program in France and received approval in the United Kingdom. However, he said reimbursement remains a challenge amid uncertainty surrounding most-favored-nation pricing policies and related discussions with governments. Madrigal reported a second-quarter net loss of $57.9 million, compared with a net loss of $42.3 million in the prior-year period. The quarterly loss included a $25 million one-time upfront business-development expense tied to the in-licensing of MGL0795, an siRNA program from Arrowhead Pharmaceuticals. Cost of sales was $40 million, compared with $9.1 million a year earlier, primarily reflecting higher royalties payable to Roche and a write-down of certain work-in-process inventory. Research and development expense rose to $91.2 million from $54.1 million, driven largely by the Arrowhead upfront payment. Selling, general and administrative expense increased to $289.4 million from $196.9 million, reflecting commercial investment in Rezdiffra, including the endocrinology field-force expansion and direct-to-consumer marketing. Stock-based compensation expense totaled $35.4 million, up from $25.2 million in the prior-year quarter. The company ended the quarter with $838.9 million in cash equivalents, restricted cash and marketable securities, down from $988.6 million at the end of 2025. Dier said Madrigal expects full-year R&D spending to be roughly in line with 2025, including announced business-development upfront payments, while SG&A spending is expected to increase as the company supports Rezdiffra’s launch. Madrigal is conducting the event-driven Phase III MAESTRO-NASH OUTCOMES trial in patients with well-compensated MASH cirrhosis, known as F4C. The company expects the study to read out in 2027 and said events are accruing in line with that timeframe, though management did not provide a more specific date or confirm the final target number of events. Chief Medical Officer Dave Allegretti said the company has enriched the trial population for risk of clinically significant portal hypertension using measures including platelet counts, liver stiffness and magnetic resonance elastography. He said any statistically significant risk reduction that supports approval could be clinically meaningful because no approved therapy currently exists for F4C MASH. At the European Association for the Study of the Liver meeting, Madrigal presented an analysis of a 122-patient open-label cohort from the MAESTRO-NAFLD-1 trial. Using the ANTICIPATE-MASH risk model, the company said the proportion of patients considered at higher risk for clinically significant portal hypertension declined from 75% at baseline to 55% after two years of resmetirom treatment. Madrigal also cited real-world data from one large gastroenterology practice, where nearly half of patients achieved at least a 25% reduction in liver stiffness over an average follow-up of about nine months. The company said it has built a MASH pipeline of more than 10 programs, including four clinical-stage assets. Madrigal began dosing its oral GLP-1 candidate, MGL-2086, in a Phase I single-ascending-dose study in June. Results from the single-ascending-dose and multiple-ascending-dose work are expected to inform a planned Phase II combination study with resmetirom in 2027. Madrigal also plans to initiate Phase II studies in 2027 evaluating its DGAT2 inhibitor, ervogastat, with resmetirom and evaluating a combination of resmetirom and MGL0795, the PNPLA3-targeting siRNA licensed from Arrowhead. The company’s F2-F3 MAESTRO-NASH Phase III study is expected to report data in 2028. Sibold said Madrigal recently received three additional patents related to Rezdiffra, including two patents supporting protection in F2-F3 MASH and one supporting a potential F4C indication. He said the company’s previously secured F2-F3 patent extends to 2045, while the newer F4C patent extends into the 2040s. Madrigal Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the development of innovative therapies for cardiovascular, metabolic and liver diseases. The company's pipeline centers on novel, liver-directed agents designed to address significant unmet medical needs, with an emphasis on nonalcoholic steatohepatitis (NASH) and related metabolic disorders. The lead product candidate, resmetirom (MGL-3196), is an orally administered, selective thyroid hormone receptor-β agonist in Phase 3 development for the treatment of NASH. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Madrigal Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.
Investor releaseQuarter not tagged2026-07-30Madrigal Pharmaceuticals Reports Second-Quarter 2026 Financial Results and Provides Corporate Updates
GlobeNewswire
Madrigal Pharmaceuticals Reports Second-Quarter 2026 Financial Results and Provides Corporate Updates
Second-quarter 2026 Rezdiffra® (resmetirom) net sales of $364.3 million, representing year-over-year growth of 71% As of June 30, 2026, more than 49,000 patients on Rezdiffra, more than doubling from 2Q25 reflecting continued strong physician adoption and high patient demand Strengthened IP portfolio with 3 new resmetirom patents, including F4c patent MGL-2086 (oral GLP-1) Phase 1 trial dosing initiated in June 2026 as part of Rezdiffra/MGL-2086 combination program in MASH Reports cash, cash equivalents, restricted cash and marketable securities of $838.9 million as of June 30, 2026 Company to host conference call today, July 30, 2026, at 8 a.m. EDT CONSHOHOCKEN, Pa., July 30, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports second-quarter 2026 financial results and provides corporate updates. Bill Sibold, Chief Executive Officer of Madrigal, stated: “Madrigal delivered another outstanding quarter driven by exceptional execution and market fundamentals. We have the foundational MASH medicine, Rezdiffra, in a rapidly expanding, high unmet need market that has remarkable potential for growth, given today’s low diagnosis and treatment rates. Earlier this month, we surpassed 50,000 active patients on Rezdiffra, an important milestone which reflects the strength of our launch and the significant need for an effective MASH treatment. Rezdiffra has already achieved nearly $1.3 billion in trailing-12-month net sales, and we’re still at the beginning of one of the largest opportunities in biotechnology.” Sibold continued: “Our strategy is straightforward: maximize the long-term value of Rezdiffra while building the industry-leading MASH pipeline. This quarter we strengthened Rezdiffra's intellectual property portfolio, advanced MGL-2086 into the clinic, and continued to generate compelling clinical and real-world evidence that reinforces Rezdiffra as the foundational therapy in MASH that demonstrates efficacy across all patient subgroups. We're investing from a position of strength and building the next generation of MASH therapies designed to extend our leadership for the long term.” Second Quarter 2026 and Recent Corporate Updates Strengthened IP portfolio with 3 new resmetirom patents Advanced MGL-20…Read full documentShow less
Second-quarter 2026 Rezdiffra® (resmetirom) net sales of $364.3 million, representing year-over-year growth of 71% As of June 30, 2026, more than 49,000 patients on Rezdiffra, more than doubling from 2Q25 reflecting continued strong physician adoption and high patient demand Strengthened IP portfolio with 3 new resmetirom patents, including F4c patent MGL-2086 (oral GLP-1) Phase 1 trial dosing initiated in June 2026 as part of Rezdiffra/MGL-2086 combination program in MASH Reports cash, cash equivalents, restricted cash and marketable securities of $838.9 million as of June 30, 2026 Company to host conference call today, July 30, 2026, at 8 a.m. EDT CONSHOHOCKEN, Pa., July 30, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reports second-quarter 2026 financial results and provides corporate updates. Bill Sibold, Chief Executive Officer of Madrigal, stated: “Madrigal delivered another outstanding quarter driven by exceptional execution and market fundamentals. We have the foundational MASH medicine, Rezdiffra, in a rapidly expanding, high unmet need market that has remarkable potential for growth, given today’s low diagnosis and treatment rates. Earlier this month, we surpassed 50,000 active patients on Rezdiffra, an important milestone which reflects the strength of our launch and the significant need for an effective MASH treatment. Rezdiffra has already achieved nearly $1.3 billion in trailing-12-month net sales, and we’re still at the beginning of one of the largest opportunities in biotechnology.” Sibold continued: “Our strategy is straightforward: maximize the long-term value of Rezdiffra while building the industry-leading MASH pipeline. This quarter we strengthened Rezdiffra's intellectual property portfolio, advanced MGL-2086 into the clinic, and continued to generate compelling clinical and real-world evidence that reinforces Rezdiffra as the foundational therapy in MASH that demonstrates efficacy across all patient subgroups. We're investing from a position of strength and building the next generation of MASH therapies designed to extend our leadership for the long term.” Second Quarter 2026 and Recent Corporate Updates Strengthened IP portfolio with 3 new resmetirom patents Advanced MGL-2086 (oral GLP-1) into Phase 1 to support Madrigal’s strategy to develop innovative combination treatments for MASH anchored by Rezdiffra Data presentations at EASL Congress in May reinforced Rezdiffra as the foundational MASH therapy MASH Across America initiative to expand disease awareness Second-Quarter 2026 Financial Results Total Revenues: Second-quarter 2026 net revenues were $364.3 million, an increase of 71% compared to $212.8 million in the comparable prior year period, driven by increased demand for Rezdiffra in the U.S. in 2026. Operating Expenses: Second-quarter 2026 operating expenses were $420.6 million, inclusive of $35.4 million in non-cash stock-based compensation expense, compared to operating expenses of $260.0 million, inclusive of $25.2 million in non-cash stock-based compensation expense for the prior year period. Net Loss: Second-quarter 2026 net loss was $57.9 million or $1.99 per share (basic and diluted) compared to a net loss of $42.3 million or $1.50 per share (basic and diluted) in the comparable prior year period. Net loss in the second quarter of 2026 was inclusive of one-time, upfront business development expenses of $25.0 million, or $0.86 per share. Cash, Cash Equivalents, Restricted Cash and Marketable Securities: As of June 30, 2026, Madrigal had cash, cash equivalents, restricted cash, and marketable securities of $838.9 million, compared to $988.6 million as of Dec. 31, 2025. Conference Call and WebcastAt 8 a.m. EDT today, July 30, 2026, Madrigal will host a webcast to review its financial and operating results and provide a general business update. To access the webcast, please visit the investor relations section of the Madrigal website or click here to register. An archived webcast will be available on the Madrigal website following the event. About MASHMetabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, the need for liver transplantation, and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S. It is the fastest-growing indication for liver transplantation in Europe. Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10 to 17 times higher risk of liver-related mortality as compared to patients without fibrosis. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients. As disease awareness improves and disease prevalence increases, the number of diagnosed patients with F2 to F4c MASH is growing. About MadrigalMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com. Forward Looking StatementsThis press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the expected growth of Rezdiffra, expected growth of the MASH market, expectations regarding patent protection for resmetirom, Madrigal’s clinical development plans and timelines for its pipeline, Madrigal’s leadership position in the MASH sector, the potential benefit of resmetirom in patients with compensated MASH cirrhosis, Rezdiffra’s ability to potentially improve cardiovascular outcomes in patients with MASH and the potential benefit of Madrigal’s pipeline candidates for the treatment of MASH. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; our ability to successfully commercialize Rezdiffra in the U.S. and Europe; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of our clinical trials, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for our trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action or of any other product candidate; market demand for and acceptance of Rezdiffra; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; our ability to protect our intellectual property rights; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by applicable law, Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s reports filed with the U.S. Securities and Exchange Commission (SEC) for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part 1, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2025, and as updated from time to time by Madrigal’s other filings with the SEC. Madrigal may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Madrigal’s website in addition to following its press releases, filings with the SEC, public conference calls, and webcasts. Madrigal Pharmaceuticals, Rezdiffra® and associated logos are trademarks of Madrigal Pharmaceuticals, Inc. Investor Contact Tina Ventura, [email protected] Media ContactChristopher Frates, [email protected] (tables follow)
Investor releaseQuarter not tagged2026-07-30Madrigal: Q2 Earnings Snapshot
Associated Press
Madrigal: Q2 Earnings Snapshot
WEST CONSHOHOCKEN, Pa. (AP) — WEST CONSHOHOCKEN, Pa. (AP) — Madrigal Pharmaceuticals Inc. (MDGL) on Thursday reported a loss of $57.9 million in its second quarter. The West Conshohocken, Pennsylvania-based company said it had a loss of $1.99 per share. The results exceeded Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of $2.55 per share. The biopharmaceutical company posted revenue of $364.3 million in the period, which also topped Street forecasts. Four analysts surveyed by Zacks expected $349.3 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on MDGL at https://www.zacks.com/ap/MDGL
TranscriptFY2026 Q22026-07-30FY2026 Q2 earnings call transcript
Earnings source - 126 paragraphs
FY2026 Q2 earnings call transcript
Good morning, thank you for standing by. Welcome to Madrigal Pharmaceuticals' Second Quarter 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will have to press star one one on your telephone. You will hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.
Good morning, everyone, thank you for joining us to discuss Madrigal's second quarter 2026 results. We issued a press release this morning and posted a 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 Allegretti, Chief Medical Officer, and Mardi Dier, Chief Financial Officer. They will provide prepared remarks, followed by Q&A. Please note on slide two, 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. I will now turn the call over to Bill on slide three.
Thanks, Tina, thank you all for joining. Before we review our second quarter results, let me remind you why we're so excited about MASH and why we believe Madrigal is uniquely positioned to lead this market. The market fundamentals are exceptional. MASH is a high unmet need disease with the potential for decades of growth, given today's low diagnosis and treatment rates and a rapidly expanding patient population. We are at the forefront of one of the most attractive growth opportunities in the industry. We also have what we believe is the foundational therapy. Rezdiffra is the first approved medicine for MASH, a liver-directed, once-daily oral medication with demonstrated efficacy across each MASH subgroup and an outstanding real-world profile. Add to that our commercial execution, our experienced team, and our industry-leading pipeline.
We believe Madrigal is exceptionally well-positioned to lead in MASH today and define where this market goes over the long term. Slide four summarizes how we're executing on our two strategic growth priorities, maximizing the value of Rezdiffra and advancing our pipeline. Rezdiffra continues to exceed expectations as we steadily add patients quarter-over-quarter. Over the last 12 months, Rezdiffra has generated nearly $1.3 billion in net sales, reinforcing its mega blockbuster potential. We're also strengthening the long-term value of the franchise. A key pillar of that strategy has been to build a robust patent estate. Last year, we secured our pivotal 2045 F2-F3 patent. This month, we build on that foundation with three additional patents, two that reinforce our protection in F2-F3 and one supporting our potential F4-C indication. As we've done successfully to date, we'll continue pursuing IP that protects the future of Rezdiffra.
Because we believe Rezdiffra is the foundational therapy in what will become a large specialty market, we're investing behind it. In less than a year, we've built what we believe is the industry-leading MASH pipeline, adding more than 10 programs. We now have four clinical-stage assets following the initiation of the phase I study of our oral GLP-1 last month. Each of our programs is designed to build on Rezdiffra's foundation and extend our leadership in MASH for years to come. We've accomplished a tremendous amount in a short period of time. We're just getting started. Our team continues to execute on these priorities to strengthen the leadership position we've established. Let's move to our Q2 results, where I'll provide an update on Rezdiffra. Dave will discuss our pipeline, and Mardi will close with a review of our financials.
Turning to slide six and net sales, we are continuing to see strong demand for Rezdiffra. Second quarter 2026 net sales were $364 million, representing year-over-year growth of 71%. This performance continues to reinforce that Rezdiffra is tracking in line with, and in many cases exceeding, the best-in-class specialty launches we compare ourselves to. Our strong performance is a result of successful launch execution. It's driving our near-term results and building the foundation for the long-term growth. Importantly, prescribers continue to tell us that Rezdiffra is performing even better in the real world, and that experience is translating into action. Today, our target specialists are prescribing Rezdiffra more often, which is driving greater depth across our prescriber base.
That growing depth, combined with broad first-line commercial access, Rezdiffra's differentiated profile, and strong patient adherence, continues to drive patient growth. 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. Importantly, momentum remains strong as we progress through the third quarter, where we surpassed the 50,000-patient milestone earlier this month, a significant accomplishment in any launch. One of the things we're most excited about is how quickly this market is developing, as shown on slide eight. From year-end 2023 to year-end 2025, the U.S. addressable market has grown nearly 50%, from 315,000 diagnosed F2/F3 patients at our target specialists to 460,000.
That's remarkable growth in just two years. It's being driven by exactly what you'd expect in a new therapeutic category, greater disease awareness, increasing diagnosis, more patients being referred to specialists, a growing urgency to treat, and increased investment by multiple companies. We have continued to see strong market growth again this year and expect the MASH market to expand at a double-digit pace for the foreseeable future. In fact, we see parallels between MASH and other large chronic disease markets like rheumatoid arthritis, IBD, and psoriasis, as shown on slide nine. Each started with one or two therapies and evolved into markets supporting more than a dozen products and more than $20 billion in annual sales. We believe that MASH will follow the same path and that Rezdiffra has a stronger profile than the first products that launched in any of those categories.
Today, we're only about 10% penetrated in a market with a roughly 10% diagnosis rate. Think about that. 10% of 10%, that's 1% of the total potential market. Yet even from that starting point, as shown on slide 11, Rezdiffra is already generating north of $1 billion in trailing 12-month net sales. That's why we're so excited about the future. We are still at the beginning of what we believe will become one of the largest specialty markets in the industry, where we have a first-to-market medicine with a best-in-disease profile. Everything I've discussed so far speaks to the strength and opportunity of Rezdiffra in F2-F3 MASH, but there is another significant unmet need ahead of us in well-compensated MASH cirrhosis, or F4C, as noted on slide 12. It's an untapped market with no approved therapies and a much higher urgency to treat.
With approximately 245,000 patients under specialist care in the U.S., we believe F4C could double Rezdiffra's opportunity. We have an event-driven outcome trial underway in F4C that, if positive, is expected to support expansion into this indication and support full approval across F2 to F4C. We see the market evolving beyond these initial stages, as noted on slide 13. Like other complex chronic diseases, treatment will evolve to include multiple mechanisms, combination regimens, and increasingly personalized approaches. That's why we've strategically invested in building the industry-leading MASH pipeline. Rezdiffra gives us a foundation no one else has, allowing us to thoughtfully add complementary mechanisms that can provide even more efficacy, broaden patient reach, and define the next generation of MASH therapies. One of the reasons we believe Rezdiffra is foundational is what we've heard consistently from prescribers over the last two years of launch.
They not only value its liver-directed efficacy, well-tolerated profile, and once-daily dosing, but appreciate that Rezdiffra works across each patient subgroup and clinical practice. That breadth and consistency across patient subgroups is exactly what you want in a foundational medicine, and it's unique to Rezdiffra. Dave will talk more about this in his section and share key data demonstrating Rezdiffra's broad efficacy. With that, I'll turn it over to Dave.
Thanks, Bill. As Bill just mentioned, for a therapy to be truly foundational, it should work effectively across patient subgroups. This is especially true in a heterogeneous disease like MASH. The forest plot on slide 14 with data from our phase III MAESTRO-MASH clinical trial demonstrates exactly that. Patients on Rezdiffra consistently demonstrated improvements across key subgroups, including fibrosis stage, diabetes status, BMI, and genetic background, risk factors that may expedite disease progression. This is another way in which we are differentiating ourselves from the competition and why healthcare providers overwhelmingly prescribe Rezdiffra when a patient is diagnosed with F2 or F3 MASH. We're not standing still. Leadership means continuing to advance the science and generating evidence that supports Rezdiffra's clinical benefit well beyond approval. It's an ongoing effort to better understand Rezdiffra, answer important clinical questions, and continue to raise the bar for what's possible in MASH.
At EASL this year, we presented more MASH abstracts than any other company. I'll highlight three presentations that reinforce our belief that Rezdiffra is the foundational therapy in MASH. First is our F4-C analysis on slide 15 using the ANTICIPATE-MASH risk model. ANTICIPATE-MASH is a validated model developed specifically for patients with MASH cirrhosis. It estimates a patient's likelihood of developing clinically significant portal hypertension, or CSPH, and future liver-related events. The MASH field is rapidly evolving. This model has become an increasingly accepted tool for assessing risk in patients with compensated MASH cirrhosis. This is an emerging area of science. We are an early adopter of this new tool. That's an important part of how we approach leadership at Madrigal. We're not simply following the evolution of the field, but we're helping pioneer new ways to understand treatment response and disease progression.
We applied the ANTICIPATE-MASH model to the 122-patient, two-year open label cohort from our phase III MAESTRO-NAFLD-1 trial. The proportion of patients classified as higher risk for CSPH declined from 75% at baseline to 55% at two years of resmetirom treatment. Why is this important? The development of portal hypertension is the key pathophysiological inflection point in compensated cirrhosis. Once patients progress to CSPH, their risk of decompensation and other serious liver-related events increases by approximately fivefold. These findings further strengthen our confidence that resmetirom has the potential to delay disease progression and improve long-term outcomes in patients with F4-C MASH. The second data set extends our understanding of Rezdiffra beyond the liver. Patients with F2-F3 MASH don't just have liver disease, they also carry substantial cardiometabolic risk.
In fact, cardiovascular disease remains the leading cause of death in this population. MASH itself is an independent driver of cardiovascular risk. Our secondary analysis from MAESTRO-MASH and MAESTRO-NAFLD-1 showed significant reductions in the ApoB, including Lp and LDL, regardless of baseline statin use. Taken together, these data suggest Rezdiffra may positively impact both liver disease and cardiovascular risk. Slide 17 highlights Rezdiffra's performance in the real world. Clinical trials establish efficacy, real-world experience builds prescriber confidence. After treating tens of thousands of patients, prescribers continue to tell us Rezdiffra is performing even better than they expected. The data at EASL support those observations. In one large gastroenterology practice, over a mean follow-up period of approximately nine months, nearly half the patients achieved at least a 25% reduction in liver stiffness, a key measure of treatment response.
Real-world evidence like this complements what we've already seen in our clinical trials and reinforces Rezdiffra's best-in-disease profile. To deepen our understanding of Rezdiffra's full clinical potential, we're broadening our evidence generation efforts across real-world studies, investigator-initiated research, and company-sponsored trials. We will continue to pursue the questions that matter most to physicians and patients. Work to generate new data that can further inform how MASH is diagnosed, treated, and managed. Putting it all together on slide 19, we've translated our leadership into action. In just one year, we've built the industry's leading MASH pipeline with more than 10 programs, including 4 clinical stage assets, all anchored by Rezdiffra. This momentum will continue into 2027 when we expect to initiate 3 phase II trials. The first will evaluate MGL-2086, our oral GLP-1 in combination with resmetirom. Our goal is to potentiate resmetirom's anti-fibrotic effect.
We began dosing MGL-2086 in a phase I single ascending dose study in June. Results from this first-in-human study will inform the phase II trial. We also plan to initiate a phase II study of our DGAT2 inhibitor, ervogastat, in combination with resmetirom, and we'll engage with regulatory authorities on the design of a phase II trial combining resmetirom with MGL0795, our siRNA targeting PNPLA3, in-licensed from Arrowhead in May. We're also progressing one of the six preclinical siRNA assets that we in-licensed from Ribocure. We recently nominated the first candidate to move into IND-enabling studies. All of this is advancing alongside our two ongoing phase III Rezdiffra trials. First, our F4-C MAESTRO Outcomes study, which is an event-driven trial that we expect to read out in 2027. Second, the F2-F3 MAESTRO-NASH study, which is primarily histology-driven, with data expected in 2028.
We've made significant progress in a very short period of time. With Rezdiffra as the foundation and long-term patent protection providing the runway to invest and innovate, we have an opportunity to define the future of MASH care and meaningfully improve the lives of patients. With that, I'll hand it over to Mardi.
Thank you, David. Turning to slide 20 and a summary of our financial results. We delivered another strong quarter, with second quarter 2026 net sales of $364.3 million, representing 71% growth year-over-year. Demand for Rezdiffra remains strong. We once again steadily added patients, more than doubling patients on Rezdiffra compared to a year ago. We also continue to effectively manage growth to net and continue to expect our growth to net discount to be in the mid to high 30s for this year. Taken together, these fundamentals support our expectation for continued steady patient adds and robust net sales growth. Moving to operating expenses, which included a total of $35.4 million of non-cash stock-based compensation expense in the quarter, compared to $25.2 million in the prior year period.
Cost of sales for the second quarter of 2026 was $40 million, compared to $9.1 million for the prior year period. Cost of sales was primarily driven by an increase in royalties payable to Roche and a write-down of certain work-in-process inventory. R&D expenses for the second quarter of 2026 were $91.2 million, compared to $54.1 million for the prior year period. The increase was primarily due to a one-time upfront business development expense of $25 million related to the in-licensing of MGL0795, a clinical stage siRNA program from Arrowhead. SG&A expenses for the second quarter of 2026 were $289.4 million, compared to $196.9 million for the prior year period. The increase was primarily due to continued investment in commercial activities for Rezdiffra, including headcount for the endocrinology field force expansion that occurred in the fourth quarter of 2025, as well as marketing efforts, including our DTC campaign.
Looking ahead, we expect full year 2026 R&D expenses to be roughly the same as 2025, which is inclusive of the one-time upfront payments we've announced for strategic business development investments in both periods. We expect full year 2026 SG&A expenses to increase compared to 2025 with the annualization of the Endo sales force as we continue to support the launch of Rezdiffra and build the foundation for long-term growth. Net loss for the second quarter of 2026 was $57.9 million compared to $42.3 million for the prior year period. Net loss for the second quarter was inclusive of a one-time upfront business development expense of $25 million. While our focus remains on supporting our top-line growth and building our pipeline, we are also preparing for profitability.
Turning to our balance sheet, we ended the second quarter of 2026 with $838.9 million in cash equivalents, restricted cash and marketable securities, compared to $988.6 million at year-end 2025. With a strong cash position, we continue to be well resourced to support the ongoing launch of Rezdiffra, the advancement of multiple pipeline programs and continued business development. To conclude on Slide 21, we believe Madrigal is exceptionally well positioned for continued value creation. With nearly $1.3 billion in trailing 12-month net sales, Rezdiffra is on its way to mega blockbuster status. As Bill said, the third quarter is off to a great start.
We've more than doubled the number of patients on therapy over the past year, while the addressable MASH market itself has expanded by nearly 50% in just two years, and we believe it's still in the early stages of what will be decades of growth. We're building on Rezdiffra's foundation with the industry-leading pipeline of more than 10 programs. We look forward to multiple future data readouts, including our phase III F4-C trial. We're investing from a position of strength with an R&D strategy designed to extend our leadership and create long-term value. Taken together, we believe Madrigal is exceptionally well-positioned, not only for continued growth in 2026, but for sustained value creation for many years to come. I'll now turn the call back over to Tina to begin the Q&A session.
Thanks, Marty. Let's move into the Q&A portion of the call. Operator, please go ahead and provide instructions for the Q&A session.
Thank you very much. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Prakhar Agrawal of Cantor Fitzgerald. Your line is open.
Hi. Congrats on the quarter, thank you so much for taking my questions. I had two. Firstly, wanted to ask about the 3Q trends. What are you seeing in expectations for net patient adds for remainder of the year? Just wanted to get a little bit of a better color on what segments are going to drive further growth here, and how do you feel about where the consensus is sitting for 3Q and full year 2026? Second question, you had started targeting endocrinologists last year. Any initial thoughts on what you are seeing on the uptake among endocrinologists? Could that be a meaningful growth segment or is it more niche right now? Thank you.
Thanks for the question, Prakhar. It's Bill. Maybe just a comment on where we are year to date here. We had really, I think, an exceptional quarter in Q2 that was driven by exceptional execution, exceptional market dynamics, and I think that is really the best indicator of where we're headed for the future. The fundamentals of the business are terrific. We have great access. 2026 is going to be another great year. As you know, we exceeded Q2 expectations. Q3 is off to a great start. We have said, We continue to steadily add patients with over 49,000 patients at the end of Q2, more than doubling year-over-year patient numbers. We did announce this 50,000 milestone, which that is a really remarkable number in any launch. I don't care whether you're in a specialty launch, non-specialty launch, 50,000 represents great progress.
That's something that we got across in July. 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. I think we're set up really well for 2026. Mardi, do you want to talk maybe a little bit about some of the specifics?
Yes, absolutely. Hi, Prakhar. Good morning, everyone. As Bill said, we're off to a great start in third quarter and we're going to expect to steadily add patients as he just discussed. With respect to third quarter and fourth quarter, what we'd like to say is that, yes, we're comfortable with the consensus quarterly growth rates for the rest of the year. Would that mean from going the consensus growth rate from second quarter to third quarter, and then again, the consensus growth rate from third quarter to fourth quarter. Taken together, just as we've said, robust sales growth for 2026.
Prakhar, just to talk about the segments where it's coming from. This continues to be driven by Hepatitis C and GIs, for the most part. That's just where the prescriptions happen, where we would expect that they're going to continue. You also asked about endocrinology. Endocrinology was a fourth quarter 2025 focus of ours. We're still really early into that. You have to remember, endocrinologists, just I'll make two real quick points about them. Number one, they've been using GLP-1s for over a decade, and they still are seeing lots of MASH and want to talk about Rezdiffra. Check that box. Number two, they just got started really in the fourth quarter of last year.
They're in kind of that first year of launch and hep and GI, they have to take their own time to wire the system, know how they're going to access their NITs, what's the pathway they have for their practice. Lots of potential in endocrinology in time, but you have to just know where they are. They're kind of nine months into the launch really at this point. Certainly very promising. Thanks.
Great. Thanks, Prakhar. Corey, next question, please.
Thank you very much. Our next question comes from the line of Ellie Merli of Barclays. Your line is open.
Hey, guys. Thanks for taking the question. Congrats on the strong performance. Just in terms of patient growth, it seemed to accelerate, versus the first quarter, I guess, what are the drivers of this and your expectations for patient growth from here? Then just in terms of F4C, I guess, how is the event rate tracking in that study? Any clarity on when in 2027 you might expect to release the data? I recognize you might not comment, but figured I would try. Thanks.
Thanks, Ellie. Thanks for the question. On the patient growth. Now I just want to make sure, just to level set, the way we report patient numbers is the number of patients that are on Rezdiffra on the last day of the quarter. That is the net of patients that are coming in the top of the funnel. Patients that are going out the bottom of the funnel, right? As you get a bigger and bigger denominator, you have more and more patients exposed to potentially dropping off. Now, the great news this year is that we've continued to steadily add patients, as I've said. We don't see that slowing down at all. Remember, you really have to do work a lot harder on the top of the funnel as you have a bigger denominator that patients can fall out of.
We're seeing persistency like a well-tolerated oral. A well-tolerated oral at the one-year mark is in that 60%-70% range. No changes there. Product's been performing exceptionally well. When we talk to the community, we hear stories of persistence, which are even higher than that. We have focused our efforts with our internal teams on how do you address persistency to have more patients stay on longer. Then how do we work with specialty pharmacies, et cetera, to get that same result. It's a real focus of ours to drive the top of the funnel, adding new patients, to keep patients on. Then we get to that net number. We think that we have a really good approach. That's why we continue to say we expect to steadily add. Maybe, Dave, I'll turn to you.
Sure, yeah.
On, F4C.
Yeah, sure. Hi, Ellie. A quick update. Clearly, MAESTRO-NASH OUTCOMES is an important trial for the field, given the unmet medical need and the fact that this is going to be the first outcomes trial in an F4C to read out with outcomes, which is a big thing for the field. The good news is we're seeing events accrue in the trial. However, as we've said in the past, this isn't, for example, a cardiovascular outcome study where you have a large number of target events. In this case, precision is very difficult and when we can be more precise, we'll provide you an update at that point. Right now we're tracking to 2027, as we've said.
Great. Thanks, Ellie. Corey, next question, please.
Thank you very much. Our next question comes from the line of Thomas Smith. Thomas, your line is open.
Hey, guys. Good morning. Congrats on the nice quarter here and thanks for taking our questions. I was wondering if you could clarify and maybe expand on the comments regarding gross to net and inventory dynamics in the quarter and how you see those evolving through the balance of 2026. Could you also clarify the contribution of Europe to the worldwide revenues and patient numbers? We saw there was an early access program that launched in France during the quarter. Anecdotally from some KOLs, it sounded like there's been some nice early uptake there. Can you just comment on that program and how you think about Europe contribution for the year? Thanks so much.
Great, Tom. Thanks. Mardi, do you want to talk about gross to net?
Yeah, absolutely. Gross to net, as we said last quarter, our gross to net projected for 2026 is in the mid to high 30s. We are right in that zone for 2Q, and that's what we expect for the rest of the year. That's really balanced with a high-demand quarter, with respect to inventory, just as we have with every quarter. No big changes there. Overall, everything's going well for the rest of the year in 2026 as we've discussed what we believe the growth rate is for the rest of the year. In Europe, do you want me to.
Yeah, I'll talk about Europe.
Go ahead. Why don't you talk about Europe?
Thanks for the question, Tom. Look, contribution of Europe is negligible in the quarter, and we would expect that to be for the year. Now let me just talk a little bit just with ex-U.S. in general. We've launched in Germany and as you say, we have the early access program in France, and we received approval in the U.K. Couple observations. This is not a U.S. disease. It's a global disease. There's a high unmet need. Interest is really high from prescribers and from patients. Reimbursement is a challenge. You have to remember we're in an MFN context here where there is still uncertainty about where that all lands. I think we're going to be in a period in the next 12, 18 months where things are still settling down.
Systems have not, when I say systems, other countries, have not yet adopted what the ask is of the administration in MFN, which is paying U.S. prices. That's something that we're at the table, we're talking with all of the governments there about this. I'm really hopeful for a long-term solution. As I said, in this time where it's just kind of really dynamic and a lot of uncertainty as to where policy lands and so forth, that's why we say it's going to be negligible. Remember, we've only launched in Germany. That's where we've done our build. We've been extremely disciplined about the build and the spend there. More to come in the following quarters. As I said, there certainly is a high unmet need. It's just we've got to solve the reimbursement piece. This isn't a Madrigal specific issue.
This is an industry issue overall.
Great. Thanks, Tom. Corey, next question, please.
Thank you very much. Our next question comes from the line of Ritu Baral of TD Cowen. Your line is open.
Good morning, guys. Thanks for taking the question. I wanted to drill down a little further on outcomes F4C, timing and sort of the drivers there for the data. Can you guys confirm that, per your design publication, that you're still aiming for that 92-event threshold? Or is there a possibility that you might want to boost powering based on what you're seeing? Further, just based on our conversations with KOLs, they indicate to us that events in F4 tend to be almost more asymptotic in the sense that they accumulate much, much more rapidly and barely at all in the first part of the trial versus more sort of linear cardiac outcome study event accumulation. Can you comment on what the natural history tells you on that event accumulation curve and how that contributes to how you're approaching giving us additional clarity and narrowing of data timing guidance?
Thanks.
Great. Thanks, Ritu. I'll pass that over to Dave.
Yeah. Thanks, Ritu. How are you doing today?
Hey.
I think the first thing to comment on is we haven't actually confirmed the target number of events. What we've said generally is there's a publication by Harrison that's a few years old that was sort of evaluating an earlier version of the protocol, and we've heard other numbers out there. What we said in general is that most of these numbers are in the ballpark, but we haven't confirmed the actual number. I think to your point about accumulation events, look, we're pioneering in this space. As we've said many times before, this is really the first well-controlled F4C outcomes trial with a therapeutic agent. We've heard the same thing from KOLs, that the possibility is that events accelerate over time as patients sort of age through the F4C pathophysiology and the development of , for example.
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. When we can be more precise, we'll provide more precision. I think what you're highlighting is one of the questions that's out there, right? It's how does the placebo sort of evolve over time within a controlled trial?
Great. Thanks.
Thanks, Ritu.
Thank you very much.
Corey, next question. Oh, yeah, go ahead. Corey, next question.
Thank you very much. Our next question comes from the line of Andy Chen of Wolfe Research. Your line is open.
Hey. Thank you for taking the question. We noticed that you provided a timeline guidance on the oral GLP-1 and the DGAT2. Just curious, can you maybe tell us a bit more about the Arrowhead asset? When is phase II going to begin? With the oral GLP-1, the SAD has initiated. Is it reasonable to maybe predict that maybe we're going to get data next year? Thank you.
Great. Thanks, Andy. Dave?
Yeah. Well, first of all, thanks for the question, Andy, on the pipeline. I love it. It's one of the main reasons why I came to Madrigal, sort of the opportunity to build a pipeline in a space where there's so much potential and so much need. What I love about our pipeline is that we have a diversity of mechanisms, and yet all of the mechanisms we know a lot about already, right? There's a lot of data on GLP-1, there's a lot of data on DGAT, there's a lot of data on PNPLA3. Specifically with respect to the programs, all of these programs have been chosen because there's a strong scientific rationale for complementarity with thyroid hormone receptor beta agonism with resmetirom.
Specifically for the oral GLP-1, as you'll 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. As you pointed out, we started our SAD last month, and we'll be running the SAD and the MAD sort of through this year, is our plan. The data from that trial will then inform the phase II study, which, after we talk to health authorities, would start in 2027. With respect to timing, we haven't given a specific date to expect phase I, but that study will sort of proceed through this year. Similar story with DGAT. We've talked about running a pretty straightforward drug-drug interaction study later this year with resmetirom and ervogastat. Again, we know a lot about ervogastat because Pfizer took the compound through phase II.
We know it provides a lot of PDFF reduction in patients with MASH, and that PDFF reduction could also potentiate resmetirom's efficacy. Once we finish that drug-drug interaction study, again, go to health authorities, talk about our phase II plan and estimate to start that in 2027. Same story with PNPLA3- That siRNA program that we licensed from Arrowhead, we start with some very good phase I data where we have a good understanding of dose range with the molecule as a monotherapy. Again, we'd have to go to health authorities to talk about the combination program and again, estimating a start in 2027. We'll provide more of an update on the specific plans in phase II as we get closer to the initiation. Right now, just based on where the programs are in their life cycle, we'd expect them to start phase II in '27.
Yeah. Just maybe just a point on the pipeline. We've brought in these assets to be used in combination with Rezdiffra. As Dave pointed out in the presentation, as I said, Rezdiffra is a foundational therapy. You see it working across various groups within MASH consistently. Our objective is to find even more efficacy, either in a subgroup or in the total MASH population. You think about that in comparison to the rest of the industry or those that are participating in MASH. They have single assets that they're hoping still to read out maybe positive data and maybe get approved and then be able to launch. They're going to be doing that, and we're going to be already moving forward with our combo strategy, which is going to raise the bar for the entire field. There's only going to be one company that has Rezdiffra.
I think that's a point that sometimes just doesn't get quite picked up or understood. We are starting from that foundational therapy, which is the building block for MASH. Thanks for the question.
Great. Thanks, Corey. Next question, please.
Thank you very much. Our next question comes from the line of Yasmeen Rahimi of Piper Sandler. Your line is open.
Good morning, team. Congrats on a great quarter and all the color. Maybe would love to get color as you guys have been, and I'm sure you're tracking sort of event rates in the real world in the F2, F3 population, which is the indication, but maybe to the extent that you're seeing if there is any off-label use in F4s, any observations that are being made there, whether it's consistent with the MAESTRO-OLE data, which you reminded us of earlier today. Just would love to get sort of real-world experience, and I know it's limited and it's probably occurring at a less extent, but appreciate any color around that. Thank you. It seems like probably if you could quantify your confidence that the data is in 2027 and the likelihood that it could get pushed out into 2028, that could also be really helpful.
Sorry for the very long-winded question.
Yes. Thanks for the question. Maybe just a comment on the real world, what we're seeing in F2, F3. You never know what's going to happen in the real world. You have your clinical studies. They read out. They're well-controlled. Everything is controlled for patients stay on drug, and you do your readout, and you create a bar chart, and everyone starts comparing against the bar chart. You get to the real world, and that's really what counts. How does the product perform? What we're hearing overwhelmingly from patients and prescribers is that Rezdiffra is performing exceptionally well. I don't hear stories of Rezdiffra not working. I speak, as you know, to hundreds of physicians, hundreds of prescribers, and I have not heard anyone say, "Bill, it isn't working." What I hear is that this is working better than I even thought it would.
It is effective, well-tolerated, safe, easy to use, supported by a great patient support program that we have here. We really take care of patients, take care of prescribers. Early feedback, and we're seeing it also in real-world evidence that's being reported, the product is performing really well, and that's exciting. You never know that. As you think about, as I said, you can compare products on a bar chart, but what really counts is when you move into the real world. You didn't ask the question about semaglutide, but semaglutide, I think is on the opposite side of that. Well-controlled clinical trial looks good in a clinical trial. In the real world, though, you have to stay on a drug, get to a high enough dose, and be on it long enough for it to actually work.
I think that's a really great example, and I think that as we look into the future, profiles really matter, and we've got a great profile. I like to call it a holy grail profile. Having been in the industry 35 years, this is what the industry's always wanted to have, a once-a-day pill that works. Maybe that's the place just to give you some context on what we're hearing in the real world. Now, regarding off-label use, look, we've been crystal clear from day one, do not use Rezdiffra in F4C patients until we have the trial complete and we know that it works. I think that is just the responsible thing to do. Also, look, it makes sense.
What you don't want to do is have a product used in an area where there could be any kind of adverse event that then carries back to your already indicated population. I think there is some use. We can't quantify it, and there isn't a lot of data to suggest what the experience has been with people. Maybe Dave, can I turn it over to you?
Just a quick add. You made a comment about the open-label experience. We didn't talk about it this time around, but we have in the past where the event rate in that 122-patient cohort over a two-year period is quite low. It's a 2%-3% annualized rate. Even though it's an open-label population, it's a well-controlled and well-characterized population with F4-C that looks very much like the MAESTRO-NASH OUTCOMES phase III population. That low event rate is some of the basis for our confidence that resmetirom could be effective in F4 as well. I think with respect to timing, as we've said, when we have more precision on the estimate, we'll provide you with an update. At this point, we're still projecting into 2027.
Great.
Okay, thanks.
Next question, please.
Thank you very much. Our next question comes from the line of Akash Tewari of Jefferies. Your line is open.
Hey, this is Manoj on for Akash. Just one on the F4-C OUTCOMES trial. Given the mean baseline platelet count in open label was around 125,000, somewhat higher than the baseline of 150,000 in the F4-C trial, do you view the event rates observed in the OLE as the realistic guide for what we should expect in the F4-C? Also, are the blinded event rates in the OUTCOMES trial tracking in line with what we would expect from the OLE data? Just a rough estimate on that point.
Dave, do you want to?
Yeah, sure. I think with reference to the platelet count, there's going to be some variability, as you know, in the measure of platelets. In general, we enriched both populations by having a very low exclusion criterion for platelet count, greater than 70,000 in the study. The distribution, as we've talked about, of patients with CSPH is pretty similar when you look at the open-label population compared to the MAESTRO-NASH OUTCOMES phase III study. If you recall, ANTICIPATE-NASH scoring and Baveno criteria are the combination of liver stiffness measurements by VCTE and platelet count. When you combine the two, you get a risk of CSPH.
I think the fact that we've sort of pushed the population towards the higher CSPH risk is one of the reasons why we're seeing events and maybe in other programs at other sponsor companies are maybe not seeing as robust accrual of events. We think we've enriched this trial in a particularly effective way, both in terms of CSPH and using other markers like MRE. I think that's the key point. Your second question was?
Whether the-
Oh, on the-
Yeah, if it is tracking in line with the expectation. Yeah.
Yeah. As we've said, the events are tracking in a way that would estimate a delivery of the data in 2027. When we're able to provide more precision on that estimate, we'll give you an update, but right now, 2027.
Great.
Okay, got it. Yeah.
Thanks, Manoj. Next question, please.
Thank you very much. Our next question comes from the line of Ash Verma of UBS. Your line is open, Ash.
Great. Thanks for taking our question. I got two on F4 also. Just maybe, can you talk about what type of relative risk reduction on the composite would position Rezdiffra as a drug that can have broad adoption based on the feedback that you're getting from physicians that use it? Realistic 50% type outcome, or can we get even a broader adoption with a lower risk reduction? That's first. Secondly, a lot of discussion on just the event rates here. Maybe just if you can help us understand on the placebo events in this study, why would this be any different than this study versus the prior 5%-10% annualized event rate that you've seen? I believe your stat plans assume to annualize 10%, but if it's more like a 5%, is it still a 2027 readout? Thank you.
All right, Dave?
I think, look, first of all, what's a clinically relevant reduction in hazard in F4-C? The reality is, I think anything that's statistically significant and yields an approval would be clinically relevant. This is a disease where there is no treatment, and these patients are really on the cusp of end-stage liver disease and either death or a transplant. I think one of the really important things is getting a medicine to these patients, and any risk reduction is going to be a big change in the field for patients. With respect to the placebo rate, we've sort of guided to the 5%-10% range based on the natural history. As you pointed out, in the earlier Harrison paper, which again was done, sort of drafted using an earlier version of the protocol, the estimate of the placebo rate was about 10%.
The 10% placebo rate, as you know, determines sort of the duration of the trial. It doesn't really affect trial powering. The hazard reduction is the key thing that determines trial powering. Those two things together, the placebo rate and the drug effect, determine the blinded event rate. As we've said, the blinded event rate is tracking in line with delivery in 2027. When we have more data, we'll provide you more precision on that estimate.
Thanks. Thanks, Ash. Corey, next question, please.
Thank you very much. Our next question comes from the line of Michael DiFiore of Evercore ISI. Michael, your line is open.
Thank you. Thanks so much for taking my question, guys. Two for me. The first regarding Rezdiffra patient growth and underlying demand. Can you separate 2Q patient growth into new starts versus reactivations following first quarter insurance disruptions versus discontinuations? My second question is, you've already reached over 10,000 prescribers and have indicated that the commercial focus is increasingly shifting towards prescription depth. My question is, what % of 2Q new prescriptions came from existing prescribers versus first-time riders, and how is that mix changing? Thank you.
Hey, thanks, Mike, for the question. Maybe let me start a little with that. You mentioned the 10,000 prescribers. That is another really significant milestone to cross in a launch. In my experience, you exceed 10,000 and you've really got your base of prescribers that can drive your future into, in this case, a mega blockbuster. That's something which hasn't sit still. We haven't reported on that number in a while, but it continues to grow. We have new prescribers all the time. When you think about that mix, you're always going to have more of your scripts on a monthly basis coming from the existing pool of prescribers. Think about it. If you add 10 prescribers on the 10,000, disproportionately, there's so many. That's not the right number, adding 10. We're adding more than that, I can assure you.
It's always going to be weighted towards the current prescribers, and that's why depth becomes much more important than breadth once you cross that 10,000 threshold. We're continuing to see across all of the prescribers just increased depth of prescriptions. Why is that? Well, because they're having good results. Why is that? Because they're diagnosing more patients and they're learning the product. They're wiring their system. They're setting up their pathways. They're making sure they have access to or have their own NITs. That is what takes time in a launch, and that's why products typically don't go from zero to 100. It takes years to get to full penetration because people just get more comfortable and work down through their deck of patients, if you will.
We're seeing exactly that, and we're tracking exactly like we had hoped and what we had thought we would. How does that translate now back to your question about monthly adds. Oh, you had said the mix. We haven't reported out on the mix of prescribers and so forth. If you think about HEPs and GIs are the predominant writers. GIs outnumber HEPs just in the country by about 10 to 1. That's where the volume is going to be, because they just have more patients and more prescribers. Okay? What about patient adds? That net number that we show, we don't break it out into what's coming in the top of the funnel, what's going out the bottom of the funnel and net. As you can see, that steadily adding, when you look back over the quarters, that's our definition of steadily adding.
Most importantly, we expect to continue to do so going forward. We're going to do everything we can to accelerate adding to the top and decelerate leaving from the bottom. That's what we do. That continues to make it a great launch. That's what I'll leave it now, Mike, and we'll update in the future. We are in really great shape on all key metrics and really the one at the end of the day that counts is patients, and that's the one that I think that is this 50,000 milestone. That is a big number. That's why we pulled that one ahead. We didn't want to wait another quarter and we knew everyone would be doing, "Well, what day of the month was it that it happened?" Let me assure you that 50,000 is consistent with the steadily adding patients.
It's a big number that the world should know about. Thanks.
Great. Thanks, Corey.
Thank you.
Next question, please.
Thank you very much. Our next question comes from the line of Jay Olson of Oppenheimer. Jay, your line is open.
Oh, hey, guys. Congrats on all the progress, and thank you for providing this update. Since you have a number of new patents and multiple levers available to drive Rezdiffra sales growth, including potential combinations, how are you thinking about the peak sales magnitude and timeline to achieve peak sales? What's your vision of how the MASH market dynamics may evolve in the next 10 years in terms of patient segmentation? Which genotypes or phenotypes do you suspect might be appropriate to target for a more personalized approach to treating MASH with precision medicine? Thank you.
Yeah. Jay, thanks for the question. Let me start with the market dynamics, because I think this is something which is really so remarkable about MASH. I'll go back, first of all, to when we communicated what the approachable patient number in F2, F3 was at the end of 2023. That was the 315,000. We did that same analysis at the end of 2025, and that was 460,000. Almost 50% growth in patients. Now, you would say, "Well, gee, how sustainable is that?" Well, here's why it's really sustainable. It's about 10% diagnosed today, the disease. We have about 10% penetration. We're about 1% into the journey. That is a setup where all the demographics, everything that we're looking at is driving towards MASH continuing to be a challenge, not just for the next three, five, 10 years, but decades.
That's the backdrop that we're against. We had almost 50% growth in two years. We expect double-digit growth for the foreseeable future, and you heard me say that Q3 is off to a strong start, but that we are expecting and seeing patient growth in the market in 2026, consistent with what we've communicated before. That growth of the market is where the real opportunity lies. As great as Rezdiffra is, as I said, in my opinion, holy grail profile, we're looking for even more efficacy in either the whole population or segments of the population. A real specific use that, how do you kind of personalize medicine? This is where the PNPLA3 deal that we did with Arrowhead, we are so excited about.
That is a very specific, identifiable patient population that could benefit from having not only a foundational therapy like Rezdiffra, where we work really well in that if you look at our presentation, but if you add to that this targeted siRNA, could we get even more efficacy? We look at there's going to be these segments that open up in time, partially driven by the data, partially driven by just natural market evolution. That's why we're not only optimistic about Rezdiffra, but a whole franchise and having a solution for patients that cover really the gamut of MASH.
We haven't commented on peak and we're not, but you have heard us say that we think that Rezdiffra has mega blockbuster potential, and that's even before we start to add these next-generation products that we're working on, which again, I'll remind you, as we have combo products, others will be still fighting for their first product in a pathway that we probably already got a combo in.
Great. Thanks, Jay. Corey, next question, please.
Thank you very much. Our next question comes from the line of Kripa Devarakonda of Truist Securities. Your line is open.
Hey, guys. Thank you so much for taking my question and congratulations on the quarter. Wanted to ask about the competitive landscape. As we get closer to a competitor phase III data in 4Q of this year, I was wondering if you can comment on how you view any potential impact on Rezdiffra if the trial were to be successful and MASH patients get another oral option. I think it also takes back to the prior question regarding fragmentation because some of our KOL checks have suggested that this drug could target specific subsegments or drugs in general could target different subsegments. Would love to hear your comments on that. Also, wanted to just ask about also the recent patents issued for resmetirom. You already had a previously issued patent extending resmetirom till 2045.
Can you just talk about the impact of the recently issued ones and how that strengthens the profile of the drug? Thank you.
Look, thank you very much for the question. There's a lot there. Maybe just starting with IP. Last July, actually, we secured our pivotal F2-F3 patent, which is the weight threshold dosing, which gives us out to 2045. The reason that patent was so important is it allows us to think about our pipeline and portfolio a little differently. We have a lot of time with Rezdiffra, so we can place a bet on earlier-stage programs or later-stage programs. We don't have a short-term problem. That's really good. The patents that we announced just, I guess this month, was it? We secured two new F2-F3 patents, and those cover important safety information in our label. Generics have to include that type of language in their label, so them trying to do a skinny label really makes it challenging for them.
These are both Orange Book-listed patents. That's just further reinforcing the 2045 patent that we have. We now have a new F4C patent. I'm really excited about this because remember, 2045 came out of the approved label, and we don't have a label yet in F4C, but we've already secured a use patent, which gets us into the 2040s as well. That's before a label where there's potentially other opportunities to generate IP. I feel like we've said all along that IP's really important, and we've made it a focus, and I think we've made really significant progress with our IP strategy. Now, I think you're probably referring to lanifibranor. That's what it was, right? Look, what we've always said, and you've heard me say before, this is going to be a big market. It can support multiple products.
The new entrants, we think, help us if there are new entrants. You still have to have a successful product, you have to get it approved and all those minor details, build a big commercial organization launch. If you get to market one day eventually, it can really help to drive growth. I think we've seen that with Wegovy. I think their being here has really helped us. You heard me say a little bit earlier, though, this isn't about comparing bar graphs anymore. It's really about the real world. We're over two years on the market, over 50,000 patients. We have high satisfaction by prescribers and patients, and it's just continuing to press. Against that backdrop, it's kind of hard to see where lanifibranor will fit. It comes down to profiles, as you heard me say many times, and we've got a great profile.
Lanifibranor, 1,200-mg pill. It's a PPAR associated with weight gain and edema. This is at a time when the world is obsessed with weight loss. We don't see weight gain as a real benefit, particularly in MASH. We did some market research with prescribers, and 80% of prescribers said they wouldn't use lanifibranor because of the weight gain. If they get here, look, MASH is a big market. We've got lots of room for more product. That's why we're building our pipeline. We think it overall helps, they got a long way to go, and we wish them luck. I think that's where I'll leave it.
Great. Thanks. Actually, we're past the top of the hour, Corey, I think we'll conclude today's call. Thank you all for your time and interest. This now concludes our call. A replay of the webcast will be available on our website in approximately two hours. Thanks for joining us.
Thank you, ladies and gentlemen, for your participation in today's conference. You may now disconnect. Have a wonderful day
Investor releaseQuarter not tagged2026-07-29Corcept Therapeutics (CORT) Q2 Earnings and Revenues Surpass Estimates
Zacks
Corcept Therapeutics (CORT) Q2 Earnings and Revenues Surpass Estimates
Corcept Therapeutics (CORT) came out with quarterly earnings of $0.36 per share, beating the Zacks Consensus Estimate of a loss of $0.04 per share. This compares to earnings of $0.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +1,000.00%. A quarter ago, it was expected that this drug developer would post a loss of $0.3 per share when it actually produced a loss of $0.3, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Corcept, which belongs to the Zacks Medical - Drugs industry, posted revenues of $256.15 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 18.38%. This compares to year-ago revenues of $194.43 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Corcept shares have added about 170.7% since the beginning of the year versus the S&P 500's gain of 8.5%. While Corcept has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Corcept was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks h…Read full documentShow less
Corcept Therapeutics (CORT) came out with quarterly earnings of $0.36 per share, beating the Zacks Consensus Estimate of a loss of $0.04 per share. This compares to earnings of $0.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +1,000.00%. A quarter ago, it was expected that this drug developer would post a loss of $0.3 per share when it actually produced a loss of $0.3, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Corcept, which belongs to the Zacks Medical - Drugs industry, posted revenues of $256.15 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 18.38%. This compares to year-ago revenues of $194.43 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Corcept shares have added about 170.7% since the beginning of the year versus the S&P 500's gain of 8.5%. While Corcept has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Corcept was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.31 on $272.69 million in revenues for the coming quarter and $0.53 on $986.45 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Madrigal (MDGL), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on July 30. This biopharmaceutical company is expected to post quarterly loss of $2.55 per share in its upcoming report, which represents a year-over-year change of -34.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Madrigal's revenues are expected to be $349.34 million, up 64.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report Madrigal Pharmaceuticals, Inc. (MDGL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-16Madrigal Pharmaceuticals to Release Second-Quarter 2026 Financial Results and Host Webcast on July 30, 2026
GlobeNewswire
Madrigal Pharmaceuticals to Release Second-Quarter 2026 Financial Results and Host Webcast on July 30, 2026
CONSHOHOCKEN, Pa., July 16, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) announced today that it will release its second-quarter 2026 financial results on Thursday, July 30, 2026, prior to the open of the U.S. financial markets. Following the announcement, Madrigal’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results. The live webcast may be accessed at the Investor Relations section of the Madrigal Pharmaceuticals website. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. The webcast will be available approximately two hours after the live webcast. About Madrigal PharmaceuticalsMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com. Investor ContactTina Ventura, Madrigal Pharmaceuticals, Inc., [email protected] Media ContactChristopher Frates, Madrigal Pharmaceuticals, Inc., [email protected]
Investor releaseQuarter not tagged2026-06-05Madrigal (MDGL) Down 7.9% Since Last Earnings Report: Can It Rebound?
Zacks
Madrigal (MDGL) Down 7.9% Since Last Earnings Report: Can It Rebound?
A month has gone by since the last earnings report for Madrigal (MDGL). Shares have lost about 7.9% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Madrigal due for a breakout? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Madrigal Pharmaceuticals, Inc. before we dive into how investors and analysts have reacted as of late. Madrigal reported first-quarter 2026 loss of $3.25 per share, narrower than the Zacks Consensus Estimate of a loss of $3.61. In the same quarter last year, the company had incurred a loss of $2.61 per share. In the first quarter, MDGL generated total revenues of $311.3 million, up significantly year over year, entirely from product sales of Rezdiffra. The metric beat the Zacks Consensus Estimate of $301 million. Rezdiffra is the first marketed drug in MDGL’s portfolio and posted significant year-over-year growth, driven by increased demand. In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the MASH indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra has also received conditional approval as the first and only therapy in the EU to treat adults with noncirrhotic MASH with moderate-to-advanced liver fibrosis. Per Madrigal, more than 42,250patients are receiving the treatment as of March 31, 2026, up 2.5 times from first-quarter 2025, reflecting continued strong physician adoption and high patient demand. During the quarter, research and development expenses more than doubled to $108.7 million in the first quarter of 2026. The massive increase can be primarily attributed to one-time, upfront business development expenses of $54.3 million. Selling, general and administrative expenses also nearly doubled in the reported quarter to $268.5 million. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant increases in headcount to support marketing efforts. Madrigal had cash, cash equivalents and marketable securities worth $817.9 million as of March 31, 2026, compared with $988.6 million as of Dec. 31, 2025. In the past month, investors have witnessed a downward tre…Read full documentShow less
A month has gone by since the last earnings report for Madrigal (MDGL). Shares have lost about 7.9% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Madrigal due for a breakout? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Madrigal Pharmaceuticals, Inc. before we dive into how investors and analysts have reacted as of late. Madrigal reported first-quarter 2026 loss of $3.25 per share, narrower than the Zacks Consensus Estimate of a loss of $3.61. In the same quarter last year, the company had incurred a loss of $2.61 per share. In the first quarter, MDGL generated total revenues of $311.3 million, up significantly year over year, entirely from product sales of Rezdiffra. The metric beat the Zacks Consensus Estimate of $301 million. Rezdiffra is the first marketed drug in MDGL’s portfolio and posted significant year-over-year growth, driven by increased demand. In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the MASH indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra has also received conditional approval as the first and only therapy in the EU to treat adults with noncirrhotic MASH with moderate-to-advanced liver fibrosis. Per Madrigal, more than 42,250patients are receiving the treatment as of March 31, 2026, up 2.5 times from first-quarter 2025, reflecting continued strong physician adoption and high patient demand. During the quarter, research and development expenses more than doubled to $108.7 million in the first quarter of 2026. The massive increase can be primarily attributed to one-time, upfront business development expenses of $54.3 million. Selling, general and administrative expenses also nearly doubled in the reported quarter to $268.5 million. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant increases in headcount to support marketing efforts. Madrigal had cash, cash equivalents and marketable securities worth $817.9 million as of March 31, 2026, compared with $988.6 million as of Dec. 31, 2025. In the past month, investors have witnessed a downward trend in estimates review. The consensus estimate has shifted -68.41% due to these changes. At this time, Madrigal has a average Growth Score of C, though it is lagging a lot on the Momentum Score front with an F. Charting a somewhat similar path, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Madrigal has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Madrigal Pharmaceuticals, Inc. (MDGL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-05-11A Look At Madrigal Pharmaceuticals (MDGL) Valuation After Strong Q1 2026 Earnings And Rezdiffra Sales Growth
Simply Wall St.
A Look At Madrigal Pharmaceuticals (MDGL) Valuation After Strong Q1 2026 Earnings And Rezdiffra Sales Growth
Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. Madrigal Pharmaceuticals (MDGL) is back in focus after its first quarter 2026 earnings, where Rezdiffra delivered 127% year over year net sales growth to US$311.3 million, while the company still reported a US$94.4 million net loss. See our latest analysis for Madrigal Pharmaceuticals. The stock has been volatile, with a 1-day share price decline of 0.90%, a 90-day share price return of 11.99%, and a 1-year total shareholder return of 78.54% as Rezdiffra sales and pipeline updates remain in focus. If you are looking for more ideas in healthcare as MASH treatments gain attention, it may be a good time to scan for other opportunities using our 35 healthcare AI stocks With Madrigal trading around US$534.86 and analysts setting a wide range of higher targets, the key question for you is simple: is the current price still attractive, or is the market already factoring in most of the future growth? Against Madrigal Pharmaceuticals' last close of $534.86, the most followed narrative pegs fair value at $671.07, framing the stock as materially mispriced based on future cash flows. Read the complete narrative. Curious what supports that higher fair value? The narrative leans heavily on rapid top line expansion, rising margins and a richer future earnings multiple. The exact mix of growth, profitability and discounting quietly does the heavy lifting. Result: Fair Value of $671.07 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this story can change quickly if competition from GLP 1 drugs eats into Rezdiffra uptake or if payer pushback compresses pricing and margins. Find out about the key risks to this Madrigal Pharmaceuticals narrative. With sentiment split between strong Rezdiffra momentum and real execution risks, it makes sense to move quickly and weigh the trade off for yourself using 3 key rewards and 1 important warning sign If you stop with just one stock, you risk leaving better opportunities on the table. Use curated screeners to quickly surface ideas that genuinely fit your style. Target potential mispricings by scanning companies that look attractively valued using the 51 high quality undervalued stocks. Strengthen your income side b…Read full documentShow less
Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. Madrigal Pharmaceuticals (MDGL) is back in focus after its first quarter 2026 earnings, where Rezdiffra delivered 127% year over year net sales growth to US$311.3 million, while the company still reported a US$94.4 million net loss. See our latest analysis for Madrigal Pharmaceuticals. The stock has been volatile, with a 1-day share price decline of 0.90%, a 90-day share price return of 11.99%, and a 1-year total shareholder return of 78.54% as Rezdiffra sales and pipeline updates remain in focus. If you are looking for more ideas in healthcare as MASH treatments gain attention, it may be a good time to scan for other opportunities using our 35 healthcare AI stocks With Madrigal trading around US$534.86 and analysts setting a wide range of higher targets, the key question for you is simple: is the current price still attractive, or is the market already factoring in most of the future growth? Against Madrigal Pharmaceuticals' last close of $534.86, the most followed narrative pegs fair value at $671.07, framing the stock as materially mispriced based on future cash flows. Read the complete narrative. Curious what supports that higher fair value? The narrative leans heavily on rapid top line expansion, rising margins and a richer future earnings multiple. The exact mix of growth, profitability and discounting quietly does the heavy lifting. Result: Fair Value of $671.07 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this story can change quickly if competition from GLP 1 drugs eats into Rezdiffra uptake or if payer pushback compresses pricing and margins. Find out about the key risks to this Madrigal Pharmaceuticals narrative. With sentiment split between strong Rezdiffra momentum and real execution risks, it makes sense to move quickly and weigh the trade off for yourself using 3 key rewards and 1 important warning sign If you stop with just one stock, you risk leaving better opportunities on the table. Use curated screeners to quickly surface ideas that genuinely fit your style. Target potential mispricings by scanning companies that look attractively valued using the 51 high quality undervalued stocks. Strengthen your income side by focusing on companies with higher yields and resilient payouts through the 12 dividend fortresses. Dial down portfolio stress by concentrating on financially steady companies using the 71 resilient stocks with low risk scores. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include MDGL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-05-07Madrigal (MDGL) Q1 2026 Earnings Transcript
Motley Fool
Madrigal (MDGL) Q1 2026 Earnings Transcript
Image source: The Motley Fool. Wednesday, May 6, 2026 at 8 a.m. ET Chief Executive Officer — William Sibold Chief Medical Officer — David Soergel Chief Financial Officer — Mardi Dier Head of Investor Relations — Tina Ventura Operator Need a quote from a Motley Fool analyst? Email [email protected] William Sibold: 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 together, the future growth opportunity is quite remarkable. Competition has helped grow the market but not at the expense of Rezdiffra. Beyond F2/F3 MASH, we're advancing our F4C outcomes trial, where an indication expansion could double the opportunity for Rezdiffra. And because we believe this is one of the most compelling opportunities in the industry, we've moved quickly to build the leading pipeline in MASH. We added to it yesterday with a new siRNA asset that targets a mutation in the PNPLA3 gene, a genetically validated driver of disease in a meaningful subset of patients. When you step back, it is hard to find another opportunity with this combination of market fundamentals and product strength. We have a first-in-disease approval a foundational therapy, a rapidly expanding market, and we are building an industry-leading pipeline. We believe Madrigal is exceptionally well positioned to win here and continue to shape the future of MASH. I'll begin with an update on the Rezdiffra launch, hand it to Dave to discuss our pipeline and R&D strategy, and Mardi will wrap up with a review of our financials. Turning to Slide 5 and net sales. first quarter 2026 net sales were $311 million, representing year-over-year growth of 127%. This performance continues to reinforce that Rezdiffra is tracking in line with and, in many cases, exceeding the best-in-class specialty launches we compare ourselves to. Over the last 2 years, we have wired the system to drive Rezdiffra's growth. We built a large and growing prescriber ba…Read full documentShow less
Image source: The Motley Fool. Wednesday, May 6, 2026 at 8 a.m. ET Chief Executive Officer — William Sibold Chief Medical Officer — David Soergel Chief Financial Officer — Mardi Dier Head of Investor Relations — Tina Ventura Operator Need a quote from a Motley Fool analyst? Email [email protected] William Sibold: 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 together, the future growth opportunity is quite remarkable. Competition has helped grow the market but not at the expense of Rezdiffra. Beyond F2/F3 MASH, we're advancing our F4C outcomes trial, where an indication expansion could double the opportunity for Rezdiffra. And because we believe this is one of the most compelling opportunities in the industry, we've moved quickly to build the leading pipeline in MASH. We added to it yesterday with a new siRNA asset that targets a mutation in the PNPLA3 gene, a genetically validated driver of disease in a meaningful subset of patients. When you step back, it is hard to find another opportunity with this combination of market fundamentals and product strength. We have a first-in-disease approval a foundational therapy, a rapidly expanding market, and we are building an industry-leading pipeline. We believe Madrigal is exceptionally well positioned to win here and continue to shape the future of MASH. I'll begin with an update on the Rezdiffra launch, hand it to Dave to discuss our pipeline and R&D strategy, and Mardi will wrap up with a review of our financials. Turning to Slide 5 and net sales. first quarter 2026 net sales were $311 million, representing year-over-year growth of 127%. This performance continues to reinforce that Rezdiffra is tracking in line with and, in many cases, exceeding the best-in-class specialty launches we compare ourselves to. Over the last 2 years, we have wired the system to drive Rezdiffra's growth. We built a large and growing prescriber base, secured first-line access with commercial payers and establish Rezdiffra as the foundational therapy in MASH. Combined with Rezdiffra's differentiated profile and strong patient adherence, our execution has enabled us to steadily add patients quarter-over-quarter as shown on Slide 6. We ended the first quarter with more than 42,250 active patients on Rezdiffra. On a year-over-year basis, patients on therapy increased by 2.5x compared to the first quarter of 2025. That is a significant achievement by any standard, but especially in a market that didn't exist before Rezdiffra's approval. This momentum reflects strong execution by the team the clear unmet need in MASH and continued demand from both prescribers and patients. And importantly, we are seeing that momentum carried into the second quarter. Slide 7 shows how quickly the MASH market is expanding. Since launch, we've seen the U.S. addressable market grow nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025. These are diagnosed F2/F3 patients seen by our target specialists. Rezdiffra's approval, together with increased industry investment has helped transform the market by driving greater awareness, referrals, diagnosis, specialist involvement and more patients seeking care. And yet, this market is still in its earliest stages. The diagnosis rate is just over 10%, and Rezdiffra penetration remains just under 10% of the 460,000 addressable patients. The MASH market has expanded rapidly and the opportunity ahead is substantial. That gives us a clear path to peak sales, and we believe no company is better positioned than Madrigal to capitalize on it. But being first in a large and growing market is only part of the story. We have established this leadership position because Rezdiffra delivering what the MASH market wants. And that is what Slide 8 highlights. After 2 years on the market, 3 things are clear. First, profile matters. Rezdiffra is the only approved liver-directed therapy in me. It has broad proven efficacy across all patient subtypes and is an oral, once-daily, well-tolerated medicine with no titration requirements. In a chronic disease, this profile is a key reason why we continue to see strong persistence and increasing depth of prescribing. Second, real-world performance matters. Pinnacle trials get a drug approved, but real-world experience determines a product success. With tens of thousands of patients treated, we've received overwhelming feedback from the community that Rezdiffra's efficacy continues to exceed expectations in the real world. This includes improvements across liver stiffness, liver fat, liver enzymes, LDL-cholesterol and Lp(a). This is the kind of real-world experience that builds confidence with prescribers and helps establish a true standard of care. And third, we have built not only a leading product but a leading MASH company. We have the right team, the right model and the right start in a market we developed from the ground up. We have executed one of the best launches in the industry where our differentiated specialty model has set a high bar for anyone launching in this space. And we have learned, refined and improved our approach along the way. We were first to market and now have a pipeline with more than 10 programs designed to extend our leadership over time. Our leadership is also reflected in our presence at key hepatology, gastroenterology and endocrinology-focused medical meetings this month where more than 40 Rezdiffra abstracts -- with more than 40 Rezdiffra extracts being presented. This includes a poster presented at DDW this week where nearly 70% of Rezdiffra prescribers surveyed said Rezdiffra has improved their patient's quality of life and nearly 70% expect to increase their Rezdiffra's use over the next 6 months. Later this month at EASL in Barcelona, we will present additional data that reinforce the breadth of Rezdiffra's effect. That includes a secondary analysis from our Maestro NASH and NAFLD 1 trials showing that reduced Lp(a) and LDL-C in patients with MASH supporting its potential to reduce cardiovascular risk independent of baseline statin use along with 2 real-world data sets that demonstrate Rezdiffra's benefit in everyday clinical practice. We believe evidence generation is a strategic advantage for Madrigal. The more we can show prescribers and payers about Rezdiffra's performance across clinically relevant endpoints, the more it's solidified as the foundational therapy. Everything we've discussed so far speaks to the strength of Rezdiffra in F2-F3 match, but there is another significant opportunity ahead of us in well-compensated mash cirrhosis or F4 C, as noted on Slide 10. It's an untapped market with no approved therapies and a much higher urgency to treat. We believe F4C to double Rezdiffra's opportunity with approximately 245,000 patients under specialist care in the U.S. We have an event-driven outcomes trial underway in 4 that, if positive, is expected to support expansion into this indication as well as support full approval across F2 to F4C. So before I turn it over to Dave to talk about our pipeline, let me reiterate how rare an opportunity Magical has. We were first to launch, we rapidly achieved blockbuster status and we are still at the very beginning of the development of this market. It's hard to find a comparable opportunity in the industry where the fundamentals are this attractive. And from that position of strength, we are now investing in the next wave of innovation to extend our leadership and define the future of MASH. With that, I'll turn it over to Dave. David Soergel: Thanks a lot, Bill. Our objective in R&D is straightforward: deliver the industry-leading pipeline in MASH to make better therapies for patients with Rezdiffra as the foundation. As shown on Slide 11, we're doing that through targeted business development and smart clinical execution, leveraging the expertise of an R&D team that pioneered modern mash drug development. Our strategy has 4 goals: first, deliver outcomes data and full approval for Rezdiffra from F2 through F4C. Second, advanced complementary mechanisms for combination with Rezdiffra to deliver the best efficacy across the mass spectrum. Third, remain modality-agnostic with development of the best combination regimens as our strategic gain. The recent addition of siRNA assets to our pipeline underscores that approach. And fourth, leverage our experience to design smarter, more informative clinical trials and use capital efficiently, taking more shots on goal and advancing only programs that serve patients' needs more effectively. The first pillar of this strategy is delivering outcomes data in FC on Slide 12. our confidence in the Maestro MASH outcomes trial is informed by the 2-year open-label experience in 122 F 4C patients from our Maestro NAFLD-1 trial. Those data are best understood in the context of how mash progresses to cirrhosis. The critical inflection point in this process is the development of clinically significant portal hypertension or CSH. It marks the transition from well-compensated disease towards decompensation when the most serious complications begin to occur. The literature is clear that patients with CFPH have meaningfully higher rates of liver-related events, and reducing CSP risk lowers those event rates. That's why the 2-year data are so important. 65% of patients with CFPH at baseline shifted into lower-risk categories by year 2. We also saw a favorable movement in other biomarkers, including liver stiffness and fibrosis-related measures. Taken together, these results support riders potential in F4C and reinforce confidence in our event-driven outcomes trial. The second pillar of our R&D strategy is advancing combination therapies anchored by Rezdiffra, which we know works broadly across patient subtypes. Slide 13 highlights our newest addition, ARO-PNPLA3, a clinical stage siRNA that we recently in-licensed from Arrowhead. We're especially excited about this asset for a couple of reasons. One, PML is a well-understood and known target for MASH based on extensive epidemiological and genome-wide association studies. Two, this is a clinical stage asset that has completed Phase I studies. And three, we know Rezdiffra works well across all patient subtypes, including PNPLA3. So a combo including Rezdiffra and this asset has the potential for improved efficacy in a subset of patients that are especially vulnerable due to their genetics. The PNPLA3 mutation is particularly prevalent among Hispanic patients. Compared to those with wild-type PNPLA3, [indiscernible] patients homozygous for the I148M mutation of PNPLA3 have a twofold higher risk of liver-related events. Approximately 30% of F2-F3 MASH patients are homozygous carriers of the PNPLA3 mutation making it a meaningful target for our development efforts. This asset is completed Phase I studies and demonstrated 2 important things. First, it's selectively effective in the genetically defined population of PNPLA3 homozygote. Second, after a single dose, it reduced liver fat by up to 46% at 12 weeks at the highest dose. We know from Maestro NASH that greater reductions in MRI-PDFF are associated with better fibrosis reductions with is different. So the goal here is straightforward. Combine a foundational therapy, Rezdiffra, that works broadly with a targeted agent that may move more patients into a high response category and potentially improve antifibrotic efficacy with a genetically tailored approach. Stepping back on Slide 14. Our pipeline now includes more than 10 programs. Rezdiffra continues in 2 Phase III outcomes-based trials. First, our F4C study, which is an event-driven trial that we expect to read out in 2027, and second, the F2/F3 study, which is primarily histology driven with data expected in 2028. These trials would make Rezdiffra the first fully approved drug with outcomes data, well ahead of other competitors. Moving down the pipeline for [indiscernible] Stat, or D2 inhibitor, the drug-drug interaction study with resmetirom remains on track to begin in the fourth quarter of this year, and we expect to initiate a Phase II combination study in 2027 following regulatory discussions. For MGL-2086, our oral GLP-1, the Phase I single ascending dose study remains on track to initiate later this quarter. For ARO-PNPLA3, our next step will be to engage with regulatory authorities on the Phase II combination trial. And our 6 siRNA targets are progressing at various stages of preclinical development. Our approach is consistent. We're building around a foundational therapy and prioritizing mechanisms that we believe are complementary mechanistically sound and capable of improving outcomes either broadly across the population or in important patient subgroups. Our goal is to ensure Madrigal is engaging with the community and driving the science, so we are delivering meaningful advances for patients. With Rezdiffra's long-term patent protection, we have the runway to invest, innovate and define the future of mash care. With that, I'll hand it over to Mardi. Mardi Dier: Thank you, Dave. Turning to Slide 15 and a summary of our financials. First quarter 2026 net sales totaled $311.3 million, up 127% year-over-year. We're off to a strong start in 2026. As we discussed on the last call, our results reflect the typical Q1 effect due to benefit plan changes in insurance reverifications plus a step-up in gross to net related to our commercial contracting efforts for first-line access. The team did an excellent job managing all the moving parts in the quarter. We were able to steadily add patients and our gross to net came in better than we anticipated. We now expect our gross to net discount to be in the mid- to high 30s for the rest of 2026. Looking ahead, the fundamentals of the business are strong. And as Bill discussed, Q2 is off to a great start. For the rest of 2026, we expect to steadily add patients and generate robust net sales growth. Moving to operating expenses, which include a total of $34 million of noncash stock-based compensation expense in the quarter. Cost of sales for the first quarter of 2026 was $26.8 million compared to $4.5 million in the prior year period. Cost of sales at this point primarily reflects royalties owed to Roche. R&D expenses for the first quarter of 2026 were $108.7 million compared to $44.2 million in the prior year period. The increase was primarily due to onetime upfront business development expenses of $54.3 million. As a reminder, the $25 million upfront payment and related expenses for ARO-PNPLA3 will be recorded in the second quarter. SG&A expenses for the first quarter of 2026 were $268.5 million compared to $167.9 million in the prior year period. The increase was primarily due to continued investment in commercial activities for Rezdiffra, including head count for the endocrinology field force expansion that occurred in the fourth quarter of 2025, as well as marketing efforts, including our DTC campaign. Looking ahead, we expect full year 2026 R&D expenses to be roughly the same as 2025 which is inclusive of the onetime upfront payments we've announced for strategic business development investments in both periods. We expect full year 2026 SG&A expenses to increase compared to 2025 with the annualization of the Endo sales force as we continue to support the launch of Rezdiffra and build the foundation for our expected long-term growth. This includes some choppiness with higher Q2 SG&A expenses in 2026 due to timing of certain marketing expenses, including DTC, then studies for the rest of the year. Net loss for the first quarter of 2026 was $94.4 million compared to $73.2 million for the prior year period. Net loss for the first quarter was inclusive of onetime upfront business development expenses of $54.3 million. While our focus remains on supporting our top line growth and building our pipeline, we are also preparing for profitability. Turning to our balance sheet. We ended the first quarter of 2026 with $817.9 million in cash, cash equivalents, restricted cash and marketable securities compared to $988.6 million at the end of 2025. The balance reflects several quarter specific uses of cash, including onetime upfront business development payments and timing of API purchases to support future Rezdiffra manufacturing. With this strong cash position, we continue to be well resourced to support the ongoing launch of Rezdiffra and the advancement of multiple pipeline programs and continued business development. So to close, Slide 16 captures what we've discussed this morning. Rezdiffra continues to deliver incredible commercial performance with a trailing 12-month net sales now exceeding $1.1 billion, and demand remained strong with patient growth more than doubling since Q1 2025. We are leading in a market that is still in the early stages of development, but has already expanded nearly 50% in the last 2 years. This reinforces both the scale and the opportunity and the runway that remains ahead of us. We also see significant upside beyond F2-F3 with F4C representing an important next phase of growth in an indication where there are currently no approved therapies. And importantly, we're not standing still. We're investing in our pipeline of more than 10 programs designed to build on Rezdiffra's foundation and extend our leadership across the full spectrum of MASH. Taken together, this is a company built for sustainable value creation. We believe Madrigal is exceptionally well positioned in 2026 and beyond. I'll now turn the call back over to Tina and open the Q&A session. Tina Ventura: Thanks, Mardi. Let's move into the Q&A portion of the call. Brilla, please go ahead and provide instructions for the Q&A session. Operator: [Operator Instructions] Our first question comes from the line of Prakhar Agarwal with Cantor Fitzgerald. Prakhar Agrawal: Congrats on the quarter. Maybe just on Rezdiffra. What are you seeing on the 2Q trends so far and the expectations for patient adds for the rest of the year? And as a follow-up, now that [indiscernible] has been on the market for MASH for a few quarters, what are you seeing on the impact to rise in the market, if any? William Sibold: Thanks for the question, Prakhar. Look, as we take a look at the Q2 trends, I mean stepping -- first of all, they're great. So I'll get to that in a second. Context over 42,250 patients on drug as we exit Q1, 2.5x growth over last year at this time, really impressive. And in the context of we are at the very beginning of a market. We fully expect this is going to be a mega blockbuster, $1.1 billion in the last 4 quarters, we're in a really great space. So to put in perspective, how are things going in the second quarter, we're off to a strong start. We're carrying that momentum. We're steadily adding patients. Maybe it's best to put it in the context of Wegovy that you mentioned as well. Wegovy had now 3/4 of launch that we've been out there. It's being used, but certainly not to the detriment of Rezdiffra. We continue to steadily add patients through it. You have to think Wegovy and GLP-1s are really becoming a background therapy. In fact, most of the doctors that we talk to say they're already on a GLP-1 when they come into the office. So they're coming into the office on a GLP-1 and they have F2-F3 MASH. So our profile looks really, really strong there. So it's out there. We're seeing them, but we're not seeing any real difference. And maybe as a final proof point as I talked about us having our best MBRx week in the last quarter. And 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] Operator: The next question comes from the line of Ash Verma with UBS. Ashwani Verma: Congrats on the quarter. So maybe just can you talk about the breadth of prescribing right now? And how do you think that would evolve? Is it fair to assume that bulk of the prescribing right now is coming from gastroenterologists. And when do you start to get traction from hepatology, which is kind of like a smaller patient audience and then endos when does that become a big source. And then on the 1Q new patient ad dynamic. So it seems like of 36,000 new patients that you added, which is lower than some of the recent quarters. We saw this dynamic in the first quarter of last year as well when you have 5,000 and then kind of doubled from there. So is it primarily the New Year insurance deductible reset that's driving that? And how does the rest of the year shake out on a new patient dynamic? William Sibold: Great. Thanks, Ash. Let me start there. 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. And remember, what we are presenting is the number of patients that are on drug on the last day of the quarter, right? So you have patients that are coming in the top and then the patients that are on drug. So it is a -- that's the Q1 effect that you have since everyone is exposed to it. So as I said in the last question, we expect to steadily add patients throughout the rest of the year. Q2 is off to a strong start. Maybe the discussion then about breadth of prescriber. We have over 10,000 prescribers now, which is plenty of breadth for us, though we continue to add new prescribers every day. When you think about just the numbers of physicians, gastroenterologists, outnumber hepatologists, 10:1. So you're going to see the majority of prescriptions that are flowing through them. hepatologists, they were out of the gates a little faster. They have treated the disease longer, probably a little bit better prepared. In fact, we know they were better prepared. We had to wire the system practice by practice with the others. Endocrinology, they're just coming on board. It was really fourth quarter that we started our efforts there. And you have to think about endocrinologists as being where gastroenterologists were about 2.5 years ago, right? So it's something that they've been seeing some match, but they haven't really thought about it. Now they're starting to more actively look and we're wiring the system for each of those endocrinologists as well. So we see them as in the future being a really productive specialty for us. As I said, they see all these patients with background -- on background GLP-1s, yet they're still seeing F2F3 MASH. So we think that in the future, that becomes a valuable specialty for us as well. Operator: The next question comes from the line of Kripadwar Kunda with Truist Securities. Unknown Analyst: I have a question about patient mix. I think you just mentioned that GLPs are likely going to be backbone therapy. But you had also previously talked about how 25% of refer patients are on a combo. Can you talk about how that has evolved over the last few quarters? And also, some of the KOL tracks, not all that we've done, say that they prefer [indiscernible] for F2 would be helpful to understand the F2/F3 split that you are seeing in the real world? William Sibold: Yes. Thanks for the question. And you're right. 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. So we expect that trend to continue. We expect that most patients that are going to come in, in the future will have had experience with the GLP-1. So those dynamics seem to be in place. Now your second question, was it's about? Tina Ventura: 50-50 still. William Sibold: And I know some people have thought, well, wouldn't prescribers want to clear the F3s first. And I think it has to do with you have a patient sitting in front of you that's 1 to 2 steps away from cirrhosis. Are you going to wait to treat an F2, not knowing how fast they're going to progress to F3 or to cirrhosis? And no, you're not going to wait. You're going to make the call on that patient what you think their risk factors are and initiate therapy. So we still see -- and that's been pretty consistent since the start of launch, about a 50-50 split between F2/F3. Operator: The next question comes from the line of Ritu Baral with TD Cowen. Ritu Baral: I have a more sort of high-level question on diagnostic growth as you see it, Bill, through the rest of the year and next year. Do you think that you could be that it could be worthwhile to spend more on disease awareness. Now that competitive diagnostic awareness programs may be slowing with the maturity of the GLP-1 launches in MASH, and how you think about maybe stepping up SG&A to support top line growth versus clinical development, versus your approach to profitability. And then if you have -- there's some client questions coming in on how you think about estimates for the full year, which still sit at 1.48, I think, but this change in gross to net. William Sibold: Okay. So let me start off with on the diagnostic growth question, Ritu. Thanks for the question. So look, I think the proof is in the market sizing that we've seen. In just 2 years, the market grew almost 50% from 315,000 addressable patients to 460,000 addressable patients. And we think that -- and remember, diagnosis went from 1.5 million to 1.9 million. What you're seeing there is that there are more patients that are being diagnosed. And most importantly, they're getting into the specialist offices that were calling on it so that there is a potential for them to get a Rezdiffra prescription. So I think our efforts -- and this is where we believe Novo's helped as well by creating more awareness of the disease. So I think that we've already seen the proof point that by having a product, by having more than one company, the market is growing. Now specifically on diagnostics, what we're also seeing is more and more interest by practices purchasing NITs and being able to do point-of-care diagnosis. And that's another good trend that we expect to continue over time. So I think that will also facilitate staging of patients and then the ability to treat and then most importantly, to see how the patients are doing over time. So maybe what I'll do now is turn it over to Mardi to answer the rest of the questions. Mardi Dier: Yes. Thanks, Ritu. And I think you had a number of questions embedded in there, so I'll pick through them. Starting with SG&A. Yes. So clearly, we want to support this what we think is going to be a mega blockbuster brand through the efforts of our sales force and our commercial efforts, including marketing campaign and DTC. And we talked about that -- and we talked about SG&A for the rest of the year, you're going to see an increase in Q2 and then steadies for the rest of the year. But absolutely, we want to be in front of the growth and support the brand as best we can. And then that leads to a question about gross to net for the year as well. So how did that look? So gross to net, as we said, we believe we have some favorability going into the rest of the year. We now have better clarity after we got through Q2. Remember, we -- this is a new brand. So we get clarity every quarter. This was a Q1 quarter that we look at what the various components are. And I would say the team did an excellent job managing gross to net for the quarter and set us up for the rest of the year. So we believe we'll be in the mid- to high 30s for the rest of the year. And I would say, for Q1, we were even a little bit more favorable to that, but we're in good shape on the gross to net side. So that leads us to now SG&A and gross to net, what we think for the full year. So 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. And then the last point that you brought up was about profitability. As we look at it, profitability, we believe is inevitable. We're going to be a profitable company, and that's why we're preparing for profitability now. If we look at 2026 specifically, we're not going to be profitable in 2026. And specifically in Q2, with the PNPLA3 acquisition, we will not be profitable in Q2 either. Could there be other quarters where we tip into profitability perhaps, but it's really going to depend on our onetime spend. But beyond 2026 without specifics, profitability is inevitable, and we're planning for that. Operator: The next question comes from the line of Yasmeen Rahimi with Piper Sandler. Yasmeen Rahimi: Congrats to a strong quarter and also really great news on hearing gross tomato go down with one of our favorite questions. But let we transition to MAESTRO outcome. I mean we're almost halfway through the year. Would love to understand at what point do you really get visibility on how the events are tracking and fine-tuning guidance? And sort of also helping understand expectations. I know you take point that looks at the event rate you've been consistent saying they're tracking. Would love to kind of get sort of color on how you're thinking about what we could learn more around [indiscernible] outcome and the upcoming between now and sort of year-end to kind of crop us for a very important pipeline expansion opportunity. William Sibold: Great, Yas. Thank you very much for the question. And it represents a huge opportunity for us. This is a really high unmet . Dave, could you -- could I pass it over to you to answer the specific questions, please? David Soergel: Sure. Yes. Thanks, Yas. Yes, I mean, obviously, a critical study for us. And as we said, we're seeing events track in range of our expectations. -- and we continue to project the trial to deliver in 2027. With these smaller-sized trials, precision is sometimes difficult, and we want to give you a good estimate of when to expect that. And so when we have that precision, we'll provide you an update. But right now, we're still saying '27 events are tracking and we're excited to see the results. Operator: The next question comes from Eli -- more with Barclays. Eliana Merle: Bill, you alluded to this with patients coming in already on GLP-1, but can you elaborate on what you're seeing in terms of combination use with GLP-1 specifically, maybe the latest in terms of the proportion of risk creation also -- and then, I guess, what does payer coverage for combination looked like since [indiscernible] got the formal label for MASH? William Sibold: Great. Thanks, Ellie. We're still seeing around 25% of patients that are concomitantly on GLP-1 with Rezdiffra. And we think that's going to increase. That's our belief is that it's just inevitable. I mean there's just really so many patients that are on a GLP. Regarding access, we have great access. I have to say. I mean, since day 1 of launch, we have had, I would call it even exceptional access. And as we moved into 2026 with the contracting that we bid, we maintain that great access. I think it's like everything else, it's a subtlety. You can use a GLP-1 in combination with Rezdiffra if the GLP-1s prescribed for one of the other indications that GLP-1 is indicated in. Now what we haven't seen and don't have good data on is just if there's any that have a double mass prescription, we don't think payers would allow that, but they're certainly allowing a GLP-1 to be used for another indication and then Rezdiffra being used for MASH. And I think from what we're hearing more and more from prescribers is that having the combination makes sense in a lot of ways. And certainly, we believe that based upon us going out and getting an oral GLP-1 last year, we think that it is a combination that could make sense. If you recall, if we saw a greater than 5% weight loss in patients that were not on the GLP-1 and our Maestro NASH trial, that it led to an improved effect on fibrosis for Rezdiffra. So we're going to pharmacologically induce that, so to speak, with the GLP-1. That's the hope, and that's the study that, as Dave said, or we said previously, we have that Phase I study of our oral GLP-1 kicking off in the next weeks. Operator: The next question comes from Thomas Smith with Leerink Partners. Thomas Smith: Congrats on the quarter. Your pipelines expanded substantially here over the last 12 months, multiple [indiscernible] programs. The oral lift that you got 2 inhibitor. It sounds like a lot of optionality, but can you just provide some updated thoughts on the clinical strategy and positioning across these doublet or triplet combos, maybe the criteria you're going to use to advance these programs beyond proof of concept. And then can you also comment on your appetite for additional deals in BD following the string of recent deals? William Sibold: Thanks, Tom. Let me just provide maybe some context about how we're thinking about our pipeline. And then Dave, if you could jump into the specifics. It goes back to this opportunity that we have. We're at the very beginning of the treatment of the disease that's had no therapies and is an incredibly high unmet need, #1 cause of liver transplants for women in America, #2 for men. We have the foundational therapy and we expect that this market is really set up for decades of growth. We're at the front end with a foundational therapy that is really effective, and we're seeing that in the real world. Feedback has just been truly impressive from what we're hearing from prescribers that are using the product and from patients as well. So when you've got this opportunity with a product that's already a blockbuster to think about long-term leadership, you take that opportunity based on the success of Rezdiffra and the future dynamics of the market and the fact that so many people have decided to step out of the market. Pfizer steps out, J&J steps out, BMS steps out, et cetera, et cetera, based on failure with some of the mining Pfizer actually just -- they just can't bring it -- they couldn't bring it forward. So it was better in our hands. So what we've done is we've gone out and looked for mechanisms of action that we think make sense in combination with Rezdiffra. Those mechanisms may not have been strong enough, good enough to compete as a monotherapy. But if we can put them together with Rezdiffra and get even more efficacy across the whole population or a subpopulation, that is a step to long-term leadership. Either as a fixed-dose combination, if it's oral or is a regimen where you've got a once-a-day pill and in every 3- to 6-month siRNA, just like the deal that we did with Arrowhead, which we think is fantastic. We've also been able to do this in an incredibly capital-efficient manner. For under $300 million, we have assembled a leading pipeline. You just don't see that. I haven't seen that in any other therapeutic area. And we -- because of our leadership position, I think, have been able to access opportunities that others it probably wouldn't make sense for. So that's how we're thinking about it. And yes, we've done a really good amount of BD in the last 10 months now, I guess it is. what's our appetite going forward? Look, we're still constantly looking at everything out there that is potential in MASH. And where we see an opportunity that could make sense with the mechanism that we like and we don't have we would look at that opportunity and bring it in. But again, Think about how we've done it already, which is extremely efficiently, and we will keep that discipline going forward. So maybe with that, I'll just pass it over to Dave to comment on any specifics. David Soergel: Yes. That's a great summary, Bill. I mean I think the one way to think about it, as Bill was highlighting, is we have the foundational therapy, right? So we Rezdiffra to look for combination partners with to improve efficacy and improve outcomes for patients. So it's the idea. And our approach has been, we look for validated targets with complementary biology, and we're modality agnostic. So that's how we built the pipeline. We have small molecules. We have siRNAs, anything that could potentially work more effectively with Rezdiffra, that's great. Now it's important to start off with -- Rezdiffra also sets a high bar. Rezdiffra works very well across all subpopulations as we've seen from MAESTRO NASH. So our bar for bringing products forward when we conduct Phase II studies is that they have to be meaningfully that could deliver an potential meaningful benefit to patients at the end of Phase II. But our decisions will all be data-driven. And we've talked about a couple of different examples where we talk about, for example, PNPLA3, where there's a very specific patient population that we're targeting. So patients who are homozygous for I148M, PNPLA3 mutations, again, highly prevalent mutation, highly burdensome in terms of clinical outcome. But we believe that with Rezdiffra as the foundation, adding PNPLA3 may provide an even greater benefit for those patients. And as Bill was just highlighting for GLP-1, it's a different strategy, right? So that's to produce modest but important weight loss for patients that can drive Rezdiffra's antifibrotic effect. So what we're looking for in early clinical development in these sort of initial combination studies are primarily will be biomarkers like changes in MRI-PDFF, but also other biomarkers of fibrosis and other blood-based and imaging biomarkers to help us make decisions about what to move forward into Phase III. But that Phase III transition has to be underpinned by data that leads us to believe that these products are going to be meaningful additions to the therapeutic armamentarium. And in every case, we believe that these programs all have that potential. William Sibold: Right. And just maybe to put a finer point on it as well. If they show a benefit, move them forward fast, if they don't, kill them fast. And that is a little bit of a -- again, another difference at Magical because we're not beholden to a single pipeline asset performing for the company to actually be something, we can be ruthless in our prosecution of these trials and we will. If it works, great. If it doesn't, I mean, great, we move on because we're already starting with the product that we have, which is Rezdiffra, which is the enabler of this strategy. Operator: The next question comes from Akash Tewari with Jeffries. Unknown Analyst: This is Manoj on for Akash. Just one on from [indiscernible] So master outcome baseline post show around 150,000 mean platelet count in the population. While this seems lower than the around 180 in the symmetry Phase II, it still seems to be higher than the FC, the LA data you were showing like which was, I think, around 120,000. So -- in the oil data you saw around 2% to 3% of [indiscernible] even, but given this outcome that baseline population platelet count is above that data. Do you expect to see some difference in the even rate there based on this platelet count difference, mean platelet count difference? William Sibold: Great. Thanks for the question. Dave, I'm going to pass it over to you. David Soergel: You got it. Yes, so you're highlighting a really important point, which is in these F4c trials, you have to ensure that you enroll the right patient population within the F4c population. F4c is not a monolithic disease, right? So patients who've just transitioned, for example, from F3 to F4 might take them a while to progress to decompensation, whereas patients who have CSPH, plenty significant portal hypertension are right on the cusp of having a decompensation event -- and those are the patients that are more likely to drive events in the near term. So as you're highlighting, one way that you measure clinically significant portal hypertension is including platelet counts, along with liver stiffness measurements, using the Baveno criteria. And as we've talked about before, in our -- both in our open-label extension study and in MAESTRO outcomes, we've allowed patients with low platelet counts, so greater than or equal to 70,000 to enroll in the study. So there are patients with quite low platelet counts. And that's not uniform across all Phase III protocols. So we believe that our outcomes trial is enriched exactly the right way. So using a variety of criteria to enrich the population to make sure that we see the outcomes as we are and yet have an opportunity to bring these patients back from the brink of big on the cusp of decompensation and bring them into less urgent stage of their disease. So I think on that basis, if you look across the open-label extension period -- open-label extension study and MAESTRO outcomes, the populations are broadly comparable. There are going to be some differences just because the sample sizes are very different. But the inclusion criteria are very similar and we are seeing rates of CS PH in both studies that give us confidence. Paul, I think we'll leave it there. Operator: The next question comes from Michael DiFiore with Evercore ISI. Unknown Analyst: Congrats on all the progress. Two for me. First, on PNPLA3, that was previously partnered and later returned to Arrowhead. And without asking you to speak for J&J, can you walk us through what Madrigal saw in the asset that made it attractive today? And what diligence gave you confidence in the program? And then I have a follow-up. William Sibold: Great. Look, maybe just a general statement, and I start with that, then I'll pass it to Dave. A lot of companies, big pharma have opted out of match, right? They either had failures or they thought they have a single asset, maybe it's not enough, which is a little bit different than us. But Dave, I'll pass it over to you to ask a specific question about why we're so excited about this asset. David Soergel: Yes. Look, I think -- I mean, you touched on it before, Bill. I mean, I think starting with the fact that we have Rezdiffra we think in our hands, adding a PNPLA3 targeted agent could deliver even better efficacy of patients who are homozygous. So again, coming back to the strategy, so validated targets complementary biology to Rezdiffra and being modality-agnostic, so why did this asset sort of fit into this? So well, clearly, it's a validated genetic target. PNPLA3 is a validated genetic target clearly linked to more rapid and progression of disease of mash and emergence of liver-related events in patients who are homozygous versus those who are wild type. And I think second, it's a proven modality. So siRNA as we've seen with other products getting to the products -- siRNA getting to the market, it's a safe modality that you can deliver once every 3 to 6, even up to 12 months. So a highly attractive modality with great tolerability. And then last, there are clinical data, right? So we had we had Phase I data in patients where we could see reductions of liver fat. So we had a proof of concept in Phase I and as we've seen with the Maestro NASH data with Rezdiffra, if you can reduce more liver fat, we can see more efficacy with [ resmetirom. ] So again, the complementarity of these 2 mechanisms was particularly compelling as well. So I think for all those reasons, we bring in a clinical stage asset, advance our pipeline and have a potential offering for patients who really need a therapy. William Sibold: Yes. And I mean, look, it was a 46% reduction in liver fat. So I mean, that's pretty impressive efficacy from our perspective. And let's see what happens when you put it in combination. I think it's a really exciting question to ask. And look, it's been through Phase I, right? This is an acceleration of our siRNA efforts. Operator: The next question comes from Andy Chan with Wolfe Research. Unknown Analyst: This is Brandon on for Andy. We're curious to know if you can rank order the different NASH combos that you have, which one are you most excited about clinically? Thanks for the question. I'll pass it over to my view is it's whichever one works the best is going to be the one that we like the best or those that work the best. But Dave, how are you thinking about it? David Soergel: Pick amongst our children. I mean I think they're -- look, we brought them in. We brought each of these assets in for the reasons that we've talked about because they all have the potential to significantly move the needle on efficacy for a subpopulation or within the broader group. The decision is about which to move forward into Phase III programs and ultimately to registration, depends on the combination data. So as we've outlined, we have -- because we're focused on MASH and we have experience in this field, a lot of experience running clinical trials in MASH. We know the sites well. We know how to run the trials. So we're going to be able to be efficient, run these studies and deliver the data that helps us make that decision. But as I said, the data have to be meaningfully different. So for PNPLA3, like Bill said, 46% reduction in MRI-PDFF is great. combined with Rezdiffra, if that's even more, we push more patients into that super responder category, amazing. We're going to bring that program into Phase III. And that's true for all of these programs. So it's really will come Phase II, and we'll move the programs forward in a way that's going to make sense to build the pipeline and to deliver value to patients. Operator: The next question comes from Jon Wolleben with Citizens. Jonathan Wolleben: Congrats on the progress. Bill, you made a comment about, I think, a path to peak sales. And I'm wondering if you could talk a little bit about what that path looks like in terms of timing, how long you get there and how big you think reefer could be down the road? William Sibold: Thanks, Jon. You noticed. Look, I think that in our belief, this is going to be a mega blockbuster. How do we get there? We continue to do what we're doing. We have the diagnosis rates increasing. We have more patients get on drug, we steadily add patients and we build our path to feed sales. I think it's pretty straightforward. We just continue to do the hard work we're doing. There's plenty of patients. The market is growing penetration rated low diagnosis rate at the moment is low. All of these things are increasing. So there's literally years and years and years ahead of this market expanding. And as I said earlier, as more companies come in, it actually helps us because it drives market expansion. Our initial focus was always on that 315,000 just who was sitting in those prescribers' offices, at the moment. Fortunately now, we even have more potential with the advent of other companies coming in and driving diagnosis, et cetera. So keep doing what we're doing, steadily add and we'll find our path to peak. Tina Ventura: Great. Thanks, Jon. Operator, we have time for 1 more question, please. Operator: And the next question comes from William Wood with B. Riley Securities. William Wood: Congrats on a very nice quarter. Just thinking about in terms of your pipeline, as you said, you've got about 10 pipeline assets as is. should we expect any more add-ons to your pipeline? And if so, what might you be looking for, whether it's more oral options, more siRNAs or maybe something that we're not really discussing here. And then also in terms of just sort of in terms of that go, no-go situation, I was curious if any projects that you've sort of brought on or been developing internally has sort of hit that threshold that you've already called and maybe speak to anything might have changed where you're looking in the future or if you're pretty content with what you're guiding now you're just looking to execute. William Sibold: William, thank you very much for the question. Look, we have assembled, I think, the leading pipeline in NASH, and we've done it for less than $300 million. again, as I said a few things, it says a lot of people still aren't interested in mesh, which is great because we are, and we're in a better position to lead the innovation based on our ability to use Rezdiffra's foundational backbone therapy. So yes, we're still looking. Clearly, we've taken quite a bit off the table for us to pursue. But it will be very mechanistic-driven is there something that we think looks particularly interesting. There's still I would say a couple of mechanisms out there, which look interesting. Then the question becomes finding one and finding one that's transactable. So expect that there may be additional. Certainly, we'd like to kind of round out the pipeline, if you will, with our -- with the remaining -- some remaining mechanisms, but we're a big way through it now. Efforts are really focused towards now getting these in the clinic generating data and being able to make decisions. So that's how we're thinking about it. But it's really, again, in less than a year's time to have come from a single asset company, that has an incredibly promising future growing into a mega blockbuster to now, because of that success, be able to build that next stage of leadership, which we think is really long-term focused. Tina Ventura: Great. Thanks, Bill. And thank you, Brilla, and thank you all for your time and interest today. This now concludes our call. A replay of this webcast will be available on our website in about 2 hours. Thanks for joining us. Operator: Ladies and gentlemen, thank you for your participation in today's conference. You may now disconnect. Have a wonderful day. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Madrigal (MDGL) Q1 2026 Earnings Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-07Madrigal Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary
Moby
Madrigal Pharmaceuticals, Inc. Q1 2026 Earnings Call Summary
Rezdiffra achieved blockbuster status with over $1.1 billion in trailing 12-month net sales, driven by its position as the first-in-disease foundational therapy. Management attributes growth to a 50% expansion of the addressable U.S. market since 2023, fueled by increased diagnosis rates and specialist involvement. Real-world performance is exceeding clinical trial expectations, with prescribers reporting significant improvements in liver stiffness, fat, and enzymes. The company has secured first-line commercial access, which management views as a critical competitive moat against emerging therapies. Strategic positioning focuses on Rezdiffra as a 'backbone' for combinations, assuming that GLP-1s will become a standard background therapy for MASH patients. Operational execution included wiring the system practice-by-practice, moving from hepatologists to a broader base of over 10,000 prescribers including gastroenterologists and endocrinologists. Management expects to steadily add patients throughout 2026, noting that April 2026 was the best month for new patient starts since launch. The F4C outcomes trial is projected to read out in 2027, potentially doubling the addressable market by expanding the label to include well-compensated cirrhosis. Guidance for gross-to-net discounts is set at the mid-to-high 30s for the remainder of 2026, reflecting stabilized commercial contracting. The R&D strategy is now 'modality-agnostic,' prioritizing the development of combination regimens like the newly licensed siRNA asset for genetically vulnerable populations. Profitability is described as 'inevitable' beyond 2026, though the company will prioritize top-line growth and pipeline investment in the near term. Q1 2026 results were impacted by typical seasonal insurance re-verifications and deductible resets, which management successfully navigated to maintain patient growth. The company recorded $54.3 million in one-time upfront business development expenses in Q1, with an additional $25 million payment for the Arrowhead asset expected in Q2. SG&A expenses are expected to increase in 2026 due to the annualization of the endocrinology sales force and timed marketing campaigns. Management noted that while GLP-1 competition exists, it has not come at the expense of Rezdiffra, as most patients are already on GLP-1s before seeking MASH-specific treatment. Our analysts just ide…Read full documentShow less
Rezdiffra achieved blockbuster status with over $1.1 billion in trailing 12-month net sales, driven by its position as the first-in-disease foundational therapy. Management attributes growth to a 50% expansion of the addressable U.S. market since 2023, fueled by increased diagnosis rates and specialist involvement. Real-world performance is exceeding clinical trial expectations, with prescribers reporting significant improvements in liver stiffness, fat, and enzymes. The company has secured first-line commercial access, which management views as a critical competitive moat against emerging therapies. Strategic positioning focuses on Rezdiffra as a 'backbone' for combinations, assuming that GLP-1s will become a standard background therapy for MASH patients. Operational execution included wiring the system practice-by-practice, moving from hepatologists to a broader base of over 10,000 prescribers including gastroenterologists and endocrinologists. Management expects to steadily add patients throughout 2026, noting that April 2026 was the best month for new patient starts since launch. The F4C outcomes trial is projected to read out in 2027, potentially doubling the addressable market by expanding the label to include well-compensated cirrhosis. Guidance for gross-to-net discounts is set at the mid-to-high 30s for the remainder of 2026, reflecting stabilized commercial contracting. The R&D strategy is now 'modality-agnostic,' prioritizing the development of combination regimens like the newly licensed siRNA asset for genetically vulnerable populations. Profitability is described as 'inevitable' beyond 2026, though the company will prioritize top-line growth and pipeline investment in the near term. Q1 2026 results were impacted by typical seasonal insurance re-verifications and deductible resets, which management successfully navigated to maintain patient growth. The company recorded $54.3 million in one-time upfront business development expenses in Q1, with an additional $25 million payment for the Arrowhead asset expected in Q2. SG&A expenses are expected to increase in 2026 due to the annualization of the endocrinology sales force and timed marketing campaigns. Management noted that while GLP-1 competition exists, it has not come at the expense of Rezdiffra, as most patients are already on GLP-1s before seeking MASH-specific treatment. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management clarified that GLP-1s like Wegovy are acting as background therapy rather than competitors, with 25% of Rezdiffra patients currently on a combination. April 2026 was confirmed as the strongest month for new prescriptions (NBRx) since the product's launch. The asset targets a specific mutation prevalent in 30% of F2-F3 patients, particularly Hispanic populations, who face a twofold higher risk of liver events. Phase I data showed a 46% reduction in liver fat, which Madrigal believes will synergize with Rezdiffra's antifibrotic effects. The patient mix remains a consistent 50-50 split between F2 and F3 stages. Management noted that doctors are not waiting for patients to progress to F3 before initiating therapy due to the risk of rapid progression to cirrhosis. Mardi Dier confirmed the company is comfortable with the full-year revenue consensus mentioned by analysts, citing improved gross-to-net visibility. While 2026 will not be profitable due to heavy R&D and SG&A investment, the company is 'preparing for profitability' as a near-term milestone. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.
Investor releaseQuarter not tagged2026-05-07Madrigal Q1 Earnings Beat, MASH Drug Sales Drive Top Line, Stock Up
Zacks
Madrigal Q1 Earnings Beat, MASH Drug Sales Drive Top Line, Stock Up
Madrigal Pharmaceuticals MDGL reported first-quarter 2026 loss of $3.25 per share, narrower than the Zacks Consensus Estimate of a loss of $3.61. In the same quarter last year, the company had incurred a loss of $2.61 per share. In the first quarter, MDGL generated total revenues of $311.3 million, up significantly year over year, entirely from product sales of its metabolic dysfunction-associated steatohepatitis (MASH) drug Rezdiffra (resmetirom), which was approved in 2024. The metric beat the Zacks Consensus Estimate of $301 million. Rezdiffra is the first marketed drug in MDGL’s portfolio, which was launched in April 2024 and posted significant year-over-year growth, driven by increased demand. Madrigal shares gained 7.4% on Wednesday, as investors were impressed by the better-than-expected earnings results. In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the MASH indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra has also received conditional approval as the first and only therapy in the EU to treat adults with noncirrhotic MASH with moderate-to-advanced liver fibrosis. Per Madrigal, more than 42,250patients are receiving the treatment as of March 31, 2026, up 2.5 times from first-quarter 2025, reflecting continued strong physician adoption and high patient demand. During the quarter, research and development expenses more than doubled to $108.7 million in the first quarter of 2026. The massive increase can be primarily attributed to one-time, upfront business development expenses of $54.3 million. Year to date, Madrigal shares have lost 7.3% against the industry’s 0.9% growth. Image Source: Zacks Investment Research Selling, general and administrative expenses also nearly doubled in the reported quarter to $268.5 million. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant increases in headcount to support marketing efforts. Madrigal had cash, cash equivalents and marketable securities worth $817.9 million as of March 31, 2026, compared with $988.6 million as of Dec. 31, 2025. As the FDA and EU approved Rezdiffra under the accelerated pathway, the continued approval will be based on promising long-term safety and efficacy data…Read full documentShow less
Madrigal Pharmaceuticals MDGL reported first-quarter 2026 loss of $3.25 per share, narrower than the Zacks Consensus Estimate of a loss of $3.61. In the same quarter last year, the company had incurred a loss of $2.61 per share. In the first quarter, MDGL generated total revenues of $311.3 million, up significantly year over year, entirely from product sales of its metabolic dysfunction-associated steatohepatitis (MASH) drug Rezdiffra (resmetirom), which was approved in 2024. The metric beat the Zacks Consensus Estimate of $301 million. Rezdiffra is the first marketed drug in MDGL’s portfolio, which was launched in April 2024 and posted significant year-over-year growth, driven by increased demand. Madrigal shares gained 7.4% on Wednesday, as investors were impressed by the better-than-expected earnings results. In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the MASH indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra has also received conditional approval as the first and only therapy in the EU to treat adults with noncirrhotic MASH with moderate-to-advanced liver fibrosis. Per Madrigal, more than 42,250patients are receiving the treatment as of March 31, 2026, up 2.5 times from first-quarter 2025, reflecting continued strong physician adoption and high patient demand. During the quarter, research and development expenses more than doubled to $108.7 million in the first quarter of 2026. The massive increase can be primarily attributed to one-time, upfront business development expenses of $54.3 million. Year to date, Madrigal shares have lost 7.3% against the industry’s 0.9% growth. Image Source: Zacks Investment Research Selling, general and administrative expenses also nearly doubled in the reported quarter to $268.5 million. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant increases in headcount to support marketing efforts. Madrigal had cash, cash equivalents and marketable securities worth $817.9 million as of March 31, 2026, compared with $988.6 million as of Dec. 31, 2025. As the FDA and EU approved Rezdiffra under the accelerated pathway, the continued approval will be based on promising long-term safety and efficacy data from the pivotal phase III MAESTRO-NASH biopsy study. This late-stage study, which provided the data for the drug's accelerated approval for MASH, is ongoing as an outcomes study, with data expected in 2028. The goal is to generate confirmatory 54-month data to verify the drug's clinical benefits and support full approval for the noncirrhotic MASH indication. In addition to the study, a second phase III outcomes study (MAESTRO-NASH OUTCOMES) is underway, evaluating the progression to liver decompensation events in patients with compensated MASH cirrhosis treated with Rezdiffra compared with placebo. Top-line data is expected in 2027. A positive outcome from this study is also expected to support the full approval of Rezdiffra for noncirrhotic MASH and expand the eligible patient population for Rezdiffra with an additional indication. The open-label extension (OLE) arm of the MAESTRO-NAFLD-1 study is also currently evaluating the drug in patients with compensated MASH cirrhosis. In 2025, Madrigal reported positive two-year data from the OLE arm. The results reinforce Rezdiffra’s potential benefit for patients with compensated MASH cirrhosis and support the ongoing MAESTRO-NASH OUTCOMES study's potential success. Earlier in 2026, Madrigal also added six preclinical siRNA programs to strengthen its pipeline and advance next-generation, genetically targeted MASH therapies alongside Rezdiffra. Such efforts demonstrate MDGL’s commitment to establishing the drug as the standard-of-care treatment for MASH. Recently, Madrigal expanded its MASH pipeline through a licensing agreement with Arrowhead Pharmaceuticals for global rights to ARO-PNPLA3, a clinical-stage siRNA candidate targeting the genetically validated PNPLA3 mutation linked to MASH. The asset is aimed at a genetically defined patient population representing roughly 30% of moderate-to-advanced fibrosis cases, with phase I data showing up to a 46% reduction in liver fat after a single high dose in PNPLA3 homozygous patients. Madrigal Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Madrigal Pharmaceuticals, Inc. Quote Madrigal currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals CPRX, Immatics IMTX and Inovio Pharmaceuticals INO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have declined from $2.82 to $2.79. CPRX shares have gained 30.8% year to date. Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%. Over the past 60 days, estimates for Immatics’ 2026 loss per share have narrowed from $1.61 to $1.49. IMTX shares have gained 9.6% year to date. Immatics’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average negative surprise of 8.06%. Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 28.8% year to date. Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Catalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report Inovio Pharmaceuticals, Inc. (INO) : Free Stock Analysis Report Madrigal Pharmaceuticals, Inc. (MDGL) : Free Stock Analysis Report Immatics N.V. (IMTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

