Positive results from the MAESTRO-NASH OUTCOMES study could make resmetirom the first medication approved for patients with compensated NASH cirrhosis, a population at high risk of progressing to adverse liver-related outcomesStudy may also support full approval of RezdiffraTM (resmetirom) in noncirrhotic NASH CONSHOHOCKEN, Pa., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis ...

CONSHOHOCKEN, Pa., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) announced today that it will release its third-quarter 2024 financial results on Thursday, Oct. 31, 2024, 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 webs ...

CONSHOHOCKEN, Pa., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) today announced the company will participate in a fireside chat at the H.C. Wainwright 8th Annual MASH Virtual Investor Conference at 2:00 P.M. ET on Monday, Oct. 7, 2024. The fireside chat will be webcast live and may be accessed here or by visiting Madrigal's website's Investor Relations Events page. A replay of the webcast will be available after the event. About Madrigal Pharmaceuticals Madrigal Pharmaceut ...

It has been about a month since the last earnings report for Madrigal (MDGL) . Shares have added about 1% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Madrigal due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. Madrigal Q2 Earnings Top, NASH Drug Drives Top Lin ...

Global Research and Evidence Lab 14 August 2024 Madrigal Pharmaceuticals Inc Rezdiffra Formulary Coverage Tracker Rezdiffra coverage substantially improves in July update (50% commercial coverage, consistent w/mgmt commentary). See inside for an overview of the data on coverage and formulary status plan by plan and how Rezdiffra coverage is changing over time. We update our proprietary monthly formulary coverage tracker for MDGL's Rezdiffra using Evidence Lab's US drug formulary monitor (access data here). ...

One player's minor pain is another's moderate gain. It's not often that a biotech wins when a big pharma stumbles, but Madrigal Pharmaceuticals (MDGL 0.64%) is now in a better place than before because of a setback at Danish drug giant Novo Nordisk (NVO 2.83%). The two cardiometabolic drug developers will avoid direct competition for the time being, and now, any head-tohead match up in the future could favor Madrigal a bit more than before. But is the biotech still a buy? Let's clarify the question by looki ...

11 1 15 F H H t I P T Ti I i 1 I T n H Klaus Vedfelt Introduction Madrigal Pharmaceutical's (NASDAQ:MDGL) stock is essentially unchanged since my last look in June, when I expressed concern over GLP-1s, like Eli Lilly's (LLY) Zepbound, popping up in treatment guidelines for metabolic dysfunction-associated steatohepatitis (MASH), effectively limiting the market for Rezdiffra, the first drug indicated for MASH. Rezdiffra reported Q2 '24 earnings on Wednesday, the company's first quarter since its launch (via ...

Madrigal Pharmaceuticals (MDGL) reported a loss of $7.10 per share in second-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of $7.55. In the year-ago quarter, the company reported a loss of $4.69. During the quarter, the company generated total revenues of $14.6 million — entirely from product sales of its recently approved nonalcoholic steatohepatitis (NASH) drug Rezdiffra, which was commercially launched this April. The metric beat the Zacks Consensus Estimate of $3.8 million. Since th ...

Financial Data and Key Metrics Changes - U.S. net product sales for Q2 2024 were $14.6 million, primarily driven by demand rather than inventory stocking [18][21] - R&D expenses increased to $71.1 million from $68.6 million in Q2 2023, with expectations for steady levels for the rest of the year [18] - SG&A expenses rose to $105.4 million from $17.8 million in Q2 2023 due to the scale-up of commercial operations following the approval of Rezdiffra [18] Business Line Data and Key Metrics Changes - Over 2,000 patients were on Rezdiffra by the end of Q2 2024, with approximately 20% of targeted prescribers writing prescriptions [4][15] - Coverage for Rezdiffra increased from 30% to over 50% of commercial lives, with nearly all plans accepting non-invasive tests (NITs) [6][15] - The time to fill prescriptions improved from an initial expectation of 60 days to closer to 30 days [5][46] Market Data and Key Metrics Changes - The company is targeting a significant NASH patient population, with 315,000 diagnosed F2/F3 patients in the U.S. [11][60] - The European market presents a substantial opportunity, with a projected increase in NASH-related hepatocellular carcinoma cases expected to rise by over 100% from 2016 to 2030 [11] Company Strategy and Development Direction - The company plans to directly launch Rezdiffra in Europe following an EMA decision expected next year, aiming to preserve the asset's full value and create a platform for future growth [10][11] - The strategy includes expanding the use of Rezdiffra to patients with compensated cirrhosis, potentially doubling the market opportunity [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in building a blockbuster medicine, emphasizing the importance of educating physicians and patients about NASH and Rezdiffra [10][15] - The company is about one-third of the way through its plan to wire the system for efficient prescription processing, with expectations for steady growth in patient and prescriber numbers [17][27] Other Important Information - The company has a strong cash position of $1.1 billion, providing resources to support the multi-year launch of Rezdiffra [19] - The gross-to-net ratio was favorable, with lower-than-expected co-pay assistance usage in Q2 2024 [18][40] Q&A Session Summary Question: Can you elaborate on the $14.6 million in net revenues, specifically the breakdown between demand and inventory? - Management indicated that the majority of the $14.6 million was driven by demand, with inventory expected to run between 2 to 4 weeks moving forward [21][22] Question: What is the update on patient numbers exiting July? - Management refrained from providing month-to-month progression but confirmed steady additions of patients and prescribers [24] Question: Will there be a significant acceleration in launch trajectory next year? - Management stated that the launch will be gradual, with expectations for improved reimbursement and physician comfort by Q1 2025 [26][27] Question: What proportion of patients are on GLP-1s? - Management noted that approximately 14% of patients in clinical trials had prior exposure to GLP-1s, but current data on patient experience is limited [30] Question: How is the uptake among gastroenterologists compared to hepatologists? - Management confirmed that hepatologists are adopting Rezdiffra more quickly, but gastroenterologists are also making progress [32][34] Question: What are the plans for commercialization in Europe? - Management confirmed a commitment to self-commercialization in Europe, starting with Germany, leveraging prior experience in the region [36][37] Question: What is the expected normalization of COGS? - Management indicated that COGS is expected to normalize in about 1.5 to 2 years, depending on demand [48]

Madrigal (MDGL) came out with a quarterly loss of $7.10 per share versus the Zacks Consensus Estimate of a loss of $7.55. This compares to loss of $4.69 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 5.96%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $6.06 per share when it actually produced a loss of $7.38, delivering a surprise of -21.78%. Over the last four quarters, the company ...