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 ...

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 ...