Core Insights - Madrigal Pharmaceuticals reported second-quarter 2024 net sales of $14.6 million from the launch of Rezdiffra, marking the first product sales recognized by the company [1][5] - Rezdiffra is now covered for over 50% of commercial lives in the U.S., with less than 5% of those requiring biopsy for diagnosis, indicating strong market acceptance [1][3] - The company plans to commercialize Rezdiffra in Europe following an expected EMA decision in mid-2025, aiming to expand its leadership in the NASH market [1][3] Financial Performance - Total revenues for Q2 2024 were $14.6 million, with a cost of sales of $0.6 million, leading to a significant increase in operating expenses to $177.2 million compared to $86.5 million in the prior year [5] - Research and development expenses were $71.1 million, while selling, general, and administrative expenses surged to $105.4 million due to prelaunch and launch activities for Rezdiffra [5] - As of June 30, 2024, the company reported cash, cash equivalents, restricted cash, and marketable securities totaling $1.1 billion, a substantial increase from $634.1 million at the end of 2023 [5][17] Market and Product Updates - Rezdiffra is positioned as the first-line therapy for patients with F2/F3 NASH/MASH according to updated expert guidelines, highlighting its efficacy in improving liver stiffness by 91% over three years [2][3] - The company is actively engaging with healthcare practices to establish patient care pathways and increase the number of prescribers for Rezdiffra [3][4] - Recent studies presented at the EASL Congress indicate that interventions like Rezdiffra can reduce the risk of progression in NASH patients, which is critical given the rising incidence of liver transplants due to NASH [4][7] Industry Context - NASH is a leading cause of liver-related mortality and is increasingly recognized as a significant healthcare burden, particularly among women in the U.S. [7][8] - Approximately 1.5 million patients in the U.S. are diagnosed with NASH, with around 525,000 having moderate to advanced liver fibrosis, representing a substantial market opportunity for Rezdiffra [9][10]

CONSHOHOCKEN, Pa., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced the appointment of Shannon Kelley as General Counsel, effective August 5, 2024. Bill Sibold, Chief Executive Officer of Madrigal, stated, "Shannon is an outstanding leader who brings a wealth of expertise to her new role as General Counsel. She joined the Madrigal team in 2024 as Chief ...

Core Insights - Madrigal Pharmaceuticals, Inc. is focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with significant unmet medical needs [1] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily oral THR-β agonist aimed at addressing the underlying causes of NASH [1] Financial and Operational Updates - Madrigal Pharmaceuticals will release its second-quarter 2024 financial results on August 7, 2024, before the U.S. financial markets open [5] - Following the announcement, a live webcast will be hosted by the company's management at 8 a.m. Eastern Time to review the financial and operating results [3][5] Webcast Information - The live webcast can be accessed through the Investor Relations section of the Madrigal Pharmaceuticals website, with a recommendation for participants to register at least 15 minutes prior to the scheduled time [6]

Core Viewpoint - Madrigal Pharmaceuticals has a significant opportunity to grow its market cap from approximately $5.8 billion to $58 billion or more by capitalizing on its unique medicine, Rezdiffra, which treats metabolic-associated steatohepatitis (MASH) [3][10]. Company Overview - Madrigal's product, Rezdiffra, is the only approved treatment for MASH, positioning the company to capture a large share of a potentially lucrative market valued at around $20 billion annually [10][12]. - The company is currently engaged in post-approval R&D to expand the drug's indications, which is crucial for accessing a larger addressable market [10]. Market Potential - The average biotech company's price-to-sales (P/S) multiple is 6.3, suggesting that if Madrigal captures a significant market share, its market cap could reach approximately $126 billion [4]. - There are at least 1.5 million diagnosed cases of MASH in the U.S., with a serious progression rate leading to cirrhosis and liver failure, highlighting the urgent need for effective treatments [17]. Investment Considerations - For an investment to potentially grow to $1 million, a starting investment of around $48,260 would be required, assuming a 10X return, which is still a considerable amount for most investors [11]. - The global market for MASH drugs could be worth between $12 billion and $35 billion, with a conservative estimate of $20 billion being used for analysis [18]. Competitive Landscape - Madrigal faces competition from major players like Eli Lilly and Novo Nordisk, which may eventually enter the market, impacting Madrigal's ability to capture the full market value [15]. - The company must continue to innovate and maintain efficacy in its R&D efforts to stay ahead of competitors [15].

Madrigal Pharmaceuticals (MDGL 0.21%) is in a position that most other biotechs envy. Its first medicine just hit the market, sales are due to start rolling in, and there aren't any other companies that can slow it down -- for now, that is. It'll be growing, and likely quickly While Rezdiffra is only indicated to treat patients with moderate-to-severe fibrosis (scarring) of the liver, the company plans to continue with its research and development (R&D) activities to test its helpfulness in the context of m ...

Now, the picture is shifting, and the odds are good that one of these players will pull ahead of the other, thereby becoming the better biotech-stock investment. The only questions are, which will it be, and for how long will it last? Let's dive in. In the future, the company hopes to pick up an indication for more severe forms of fibrosis as well as cirrhosis, and it's currently pursuing clinical trials on that front. Being able to treat cirrhosis would expand its addressable market significantly, but inve ...

Core Insights - Rezdiffra shows potential in treating patients with NASH and moderate to advanced liver fibrosis by reversing fibrosis and preventing disease progression [1][28] - The Phase 3 MAESTRO-NASH trial demonstrated that Rezdiffra achieved both primary endpoints of fibrosis improvement and NASH resolution [10][28] - Rezdiffra treatment resulted in significant improvements in health-related quality of life (HRQL) for patients with NASH [4][5][28] Group 1: Treatment Efficacy - Noninvasive test data over three years indicate a durable treatment response to Rezdiffra, with 91% of treated patients showing improved or stable liver stiffness compared to placebo [2][28] - Both doses of Rezdiffra (80 mg and 100 mg) demonstrated similar improvements in liver stiffness and fat content, predicting fibrosis improvement and NASH resolution [3][28] - In patients with MetALD, Rezdiffra achieved fibrosis improvement rates of 88% for the 100 mg dose and 81% for the 80 mg dose, compared to 14% in the placebo group [7][28] Group 2: Health-Related Quality of Life - Patients receiving Rezdiffra showed significant improvements in HRQL scores, particularly in the Worry domain of the Chronic Liver Disease Questionnaire-NASH [5][28] - Biopsy responders with stage F3 fibrosis at baseline experienced more pronounced HRQL improvements compared to those with lower fibrosis stages [5][28] Group 3: Study Design and Future Directions - The MAESTRO-NASH trial enrolled 1,759 patients with biopsy-confirmed NASH, with ongoing studies to confirm clinical benefits over a 54-month period [8][11][28] - The trial's primary endpoints included NASH resolution without worsening fibrosis and improvement in fibrosis by at least one stage [9][28] - Continued approval for Rezdiffra may depend on the verification of clinical benefits in ongoing confirmatory trials [28]

It's not the most prominent biotech, but it has an important claim to fame. Madrigal Pharmaceuticals' (MDGL -0.79%) shares are down by 27% over the past year, while the S&P 500 is up by 26%. However, this poor performance hardly reflects the progress the biotech has made. Madrigal recently earned regulatory approval for Rezdiffra, a therapy for non-alcoholic steatohepatitis (NASH). Not only was Rezdiffra Madrigal's first product on the market, but it is also the first and only approved by the U.S. Food and ...

Financial Data and Key Metrics Changes - The company recorded no revenue from Rezdiffra in the first quarter of 2024 as initial shipments began in April [51] - The net cash balance as of March 31, 2024, stood at $1.1 billion, bolstered by a public offering that raised $690 million [53][32] - SG&A expenses increased to $81 million compared to $16 million in the first quarter of 2023, reflecting the scale-up of commercial operations [59] Business Line Data and Key Metrics Changes - The company is focused on establishing Rezdiffra as the foundational therapy for NASH patients with moderate to advanced fibrosis, with a strong product profile and first-to-market advantage [23][34] - The launch strategy includes targeting the right physicians, with 75% of prescriptions coming from top targets [38][44] Market Data and Key Metrics Changes - The company expects full Medicare coverage to be in place by early next year, which will facilitate patient flow through physician offices [36] - Coverage is currently in place for 30% of commercial lives, with a target of 80% by year-end [42] Company Strategy and Development Direction - The company aims to be the leading player in NASH, with plans for geographic expansion and a robust pipeline beyond Rezdiffra [9][31] - The strategy includes building care pathways for NASH patients and engaging with payers to ensure coverage [39][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Rezdiffra, citing overwhelming positive feedback from prescribers and a significant unmet need in the NASH market [21][58] - The company is optimistic about the potential for Rezdiffra to alleviate the financial burden of NASH, with a focus on patient education and support [47][48] Other Important Information - The company is advancing the MAESTRO-NASH outcomes trial, which could provide first-in-disease outcomes data years ahead of competitors [32][40] - The company has established a comprehensive patient support program to assist patients with co-pay assistance and access to the medication [108] Q&A Session Summary Question: Can you discuss the early payer coverage and the VA decision? - Management indicated that there is no read-through from the VA decision to other payers, as each makes independent decisions [88] Question: What proportion of top physician targets have written prescriptions? - Most prescriptions are coming from the top 6,000 target physicians, with many going through medical exceptions due to the lack of established pathways [64][65] Question: How is the company addressing patient services and free drug availability? - The company has a comprehensive patient support program, including co-pay assistance and potential free drug for underinsured patients [108][103] Question: What are the expectations for revenue in 2024? - Revenue is expected to be back-end loaded for the year, with modest sales anticipated in the second quarter due to the time required to wire the system [92][51]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Table of Contents OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 _________________________ MADRIGAL PHARMACEUTICALS, INC. (Exact name of regis ...