CONSHOHOCKEN, Pa., June 02, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) today announced that the company will participate in the 46th Annual Global Goldman Sachs Health Care Conference on Wednesday, June 11, 2025 at 10:40 A.M. EDT. The presentation will be webcast live and may be accessed here or by visiting Madrigal’s Investor Relations Events and Presentations page. A replay of the webcast will be available after the event. About MadrigalMadrigal Pharmaceuticals, Inc. (Nasdaq: M ...

Core Insights - Madrigal Pharmaceuticals has successfully launched Rezdiffra (resmetirom) for nonalcoholic steatohepatitis (NASH) in April 2024, achieving net sales of $137.3 million in Q1, surpassing the $100 million per quarter threshold [1] Company Performance - The drug Rezdiffra has shown strong market performance shortly after its launch, indicating a robust demand in the NASH treatment space [1] Market Context - The success of Rezdiffra reflects the growing interest and investment in biotech stocks, particularly those focused on FDA-regulated industries and significant health conditions like NASH [1]

Madrigal Pharmaceuticals (MDGL) Update / Briefing May 13, 2025 08:00 AM ET Speaker0 Good day. Thank you for standing by. Welcome to Montreal Pharmaceuticals' Residra Two Year Compensated Mascidrosis Data and EASL twenty twenty five 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. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relat ...

Core Insights - Madrigal Pharmaceuticals announced positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra, showing significant improvements in liver health metrics among patients with compensated MASH cirrhosis [1][2][3] Group 1: Study Results - The study involved 122 patients, with 113 completing two years of treatment, demonstrating a mean reduction of 6.7 kPa in liver stiffness, which is statistically significant [5][8] - 65% of patients with clinically significant portal hypertension (CSPH) at baseline moved to lower risk categories by year two, indicating a positive shift in patient outcomes [4][8] - Among patients with probable CSPH at baseline, 57% transitioned to the no/low CSPH category, further supporting the efficacy of Rezdiffra [4] Group 2: Safety and Tolerability - Rezdiffra was well-tolerated, with a low discontinuation rate due to adverse events; the most common side effects included diarrhea, COVID-19, and nausea [6][8] - Safety data were consistent with previous studies, reinforcing the drug's favorable safety profile [6] Group 3: Mechanism and Future Trials - Rezdiffra acts as a THR-β agonist, which is mechanistically supported to improve outcomes in patients with compensated MASH cirrhosis [7] - A larger placebo-controlled study is anticipated to confirm the benefits of Rezdiffra in this high-risk population, with ongoing trials expected to provide further insights [2][14] Group 4: Market Context - MASH is projected to become the leading cause of liver transplantation in the U.S., highlighting the urgent need for effective treatments [10][11] - An estimated 1.5 million patients have been diagnosed with MASH in the U.S., with Madrigal targeting approximately 315,000 patients with moderate to advanced fibrosis [12]

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Core Viewpoint - Madrigal Pharmaceuticals reported a narrower loss in Q1 2025 compared to the previous year and exceeded revenue expectations due to strong sales of its newly launched drug Rezdiffra for metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Financial Performance - The company reported a loss of $3.32 per share, better than the Zacks Consensus Estimate of a loss of $3.62, and significantly improved from a loss of $7.38 per share in the same quarter last year [1] - Total revenues for the quarter reached $137.3 million, all from Rezdiffra sales, surpassing the Zacks Consensus Estimate of $114 million [2] - Research and development expenses decreased by 38% to $44.2 million due to reduced clinical study costs and changes in inventory accounting [4] - Selling, general and administrative expenses rose to $167.9 million from $80.8 million year-over-year, attributed to increased commercial activities for Rezdiffra [5] - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $848.1 million, down from $931.3 million at the end of 2024 [5] Product and Market Updates - Rezdiffra received accelerated FDA approval in March 2024, becoming the first approved therapy for MASH, with over 17,000 patients currently receiving treatment [3] - Madrigal has submitted a regulatory filing in the EU for Rezdiffra, with a decision expected in mid-2025 [8] - Ongoing studies, including the pivotal phase III MAESTRO-NASH biopsy study, aim to provide long-term safety and efficacy data to support full approval of Rezdiffra [9][10] - Positive two-year data from the MAESTRO-NAFLD-1 study indicated a significant reduction in liver stiffness among treated patients, reinforcing the drug's potential benefits [11][12][13] Stock Performance - Year-to-date, Madrigal shares have increased by 8.2%, outperforming the industry, which has seen a decline of 2.2% [6]

Madrigal (MDGL) came out with a quarterly loss of $3.32 per share versus the Zacks Consensus Estimate of a loss of $3.62. This compares to loss of $7.38 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8.29%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $4.12 per share when it actually produced a loss of $2.71, delivering a surprise of 34.22%.Over the last four quarters, the company ha ...

Financial Performance - For the three months ended March 31, 2025, the company recorded $137.3 million in product revenue, net, representing a 100% increase compared to the previous year[134]. - The cost of sales for the same period was $4.5 million, also reflecting a 100% increase due to the sales of Rezdiffra[135]. - Selling, general and administrative expenses increased by 108% to $167.9 million compared to $80.8 million in the previous year[133]. - The total operating expenses for the three months ended March 31, 2025, were $216.6 million, a 42% increase from $152.0 million in the same period last year[133]. - The net loss for the quarter was $73.2 million, a 50% improvement from a net loss of $147.5 million in the prior year[133]. Research and Development - Research and development expenses decreased by 38% to $44.2 million from $71.2 million in the prior year[133]. - Research and development expenses decreased to $44.2 million for the three months ended March 31, 2025, down 38% from $71.2 million in 2024[136]. - The company intends to selectively in-license or acquire rights to programs at all stages of development to diversify its portfolio and enhance its drug development capabilities[118]. Product Approval and Market Potential - The FDA approved Rezdiffra in March 2024, making it the first therapy for patients with MASH, and it became commercially available in April 2024[112]. - The company estimates approximately 1.5 million patients in the U.S. have been diagnosed with MASH, with about 525,000 having moderate to advanced fibrosis[115]. - The company plans to commercialize Rezdiffra in Europe, with a regulatory decision expected in mid-2025 and a potential launch starting in Germany in the second half of 2025[117]. Cash Flow and Financing - Cash, cash equivalents, restricted cash, and marketable securities totaled $848.1 million as of March 31, 2025, down from $931.3 million at the end of 2024, reflecting funding of operations[141]. - Net cash used in operating activities was $88.9 million in Q1 2025, a decrease of 40.3% from $149.2 million in Q1 2024[155]. - Net cash provided by investing activities was $163.9 million in Q1 2025, compared to $98.1 million in Q1 2024, primarily from sales and maturities of marketable securities[156]. - Net cash provided by financing activities was $8.6 million in Q1 2025, a significant drop from $573.7 million in Q1 2024, which included proceeds from a public offering[157]. - As of March 31, 2025, the outstanding principal under the Loan Facility was $115.0 million, with an interest rate of 9.95%[149]. - As of March 31, 2025, the company had drawn $115.0 million under the $250.0 million Loan Facility[160]. Future Outlook and Risks - The company anticipates continued significant losses until sufficient revenue is generated from Rezdiffra and other future products[142]. - The company has the ability to delay certain commercial and research activities due to liquidity concerns until those concerns are alleviated[142]. - There have been no material changes to market risks since December 31, 2024, and no near-term changes are anticipated[164]. - No significant changes to contractual obligations and commitments occurred during the three months ended March 31, 2025, compared to the previous fiscal year[163]. - The company received FDA approval for Rezdiffra in March 2024, with a tiered single-digit royalty payable to Roche on net sales[161]. - The company had approximately $89.1 million of obligations under agreements related to active pharmaceutical ingredients, expected to be paid through December 2027[162].

Madrigal Pharmaceuticals (MDGL) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Company Participants Tina Ventura - Chief Investor Relations OfficerBill Sibold - CEO & DirectorMardi Dier - CFOAndrea Newkirk - Biotechnolgy Equity ResearchAkash Tewari - Managing DirectorLiisa Bayko - Managing DirectorMayank Mamtani - Senior Managing DirectorEmma Gutstein - Equity Research Associate Conference Call Participants Eliana Merle - AnalystRitu Baral - MD & Senior Biotechnology AnalystYasmeen Rahimi - Sr. Research Ana ...

Madrigal Pharmaceuticals (MDGL) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good day, and thank you for standing by. Welcome to Magical Pharmaceuticals First Quarter twenty twenty five 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. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ah ...