Madrigal Pharmaceuticals: The GLP-1 Threat May Be Overcooked

seekingalpha06-12

Madrigal Pharmaceuticals, Inc. stock has enjoyed peaks and troughs as it has pursued its path to the approval of NASH drug Rezdiffra.The company's stock was buoyant yesterday, enjoying a 15% gain ...

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href=https://seekingalpha.com/article/4698855-madrigal-pharmaceuticals-the-glp-1-threat-may-be-overcooked><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Madrigal Pharmaceuticals, Inc. stock has enjoyed peaks and troughs as it has pursued its path to the approval of NASH drug Rezdiffra.The company's stock was buoyant yesterday, enjoying a 15% gain ...</p>\n\n<a href=\"https://seekingalpha.com/article/4698855-madrigal-pharmaceuticals-the-glp-1-threat-may-be-overcooked\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1267930730.SGD","symbol_name":"富兰克林美国机遇基金AS Acc SGD 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Madrigal has a significant first mover advantage, an orally available drug, and every chance to develop Rezdiffra into a \"blockbuster\" drug.Despite challenges, Madrigal's strong financial position, experienced CEO, and potential market expansion make it a compelling investment opportunity.   Tom Werner/DigitalVision via Getty Images Investment Overview - Madrigal Stock's Pattern Of Highs And Lows I have been covering Madrigal Pharmaceuticals (NASDAQ:MDGL) for Seeking Alpha since February 2021, when I published my first note, and if I had stuck with my \"buy\" recommendation made back then I would be looking at a 142% return on investment in a little over 3 years - a handsome return by anybody's standards. That doesn't quite tell the full story, however - Madrigal's only drug of note is Resmetirom, a once-daily, oral, liver-directed thyroid hormone receptor-β (THR-β) agonist, indicated to treat patients with nonalcoholic steatohepatitis (\"NASH\"), now known by a different name, metabolic dysfunction-associated steatohepatitis (\"MASH\") - we will stick with NASH for the purposes of this post, however. In 2018, the company released positive Phase 2 data suggesting resmetirom may effectively treat patients with NASH - the drug demonstrated statistical significance in the primary endpoint (p<0.0001), the relative reduction of liver fat compared with baseline on magnetic resonance imaging-estimated proton density fat fraction, or MRI-PDFF, at 12-weeks. Madrigal's share price soared from $115, to ~$280 practically overnight, but it would be four long years before the company finally shared pivotal Phase 3 data, in December 2022, by which time the market had more or less given up on the company's chances of winning the \"NASH Dash,\" and the share price had sunk as low as $70. The almost impossibly late positive Phase 3 data sent the stock price skyrocketing once again, however, to >$300 per share, and set resmetirom on a path to a historic first approval of any drug in the indication of NASH - a 1.5m patient population, and a double-digit billion market-in-waiting. The 52-week, 1,759 patient study had two primary endpoints - NASH resolution with no worsening of fibrosis, and an improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score - and both were met. Still, the market fretted over whether Madrigal's data would be sufficient to meet the FDA's stringent criteria for approval - in October 2023, the share price had dipped <$130 once again. Finally, on March 14th 2014, Madrigal management was able to announce: the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. It is important to note that last sentence - accelerated approval will only be converted to full approval pending positive data from a post-marketing study, currently being conducted by Madrigal. Should the data not meet study endpoints, Rezdiffra risks being withdrawn from the market. Madrigal stock responded by trading >$250 per share, yet now fears began to surface about the newly approved drugs' commercial prospects - and most notably, the threat of a new class of drug in the form of GLP-1 agonists. Madrigal Shrugs Off GLP-1 Threat As Analysts Back The First Mover For Success The best known GLP-1 drugs are Eli Lilly's (LLY) tirzepatide, marketed and sold in the indication of Type 2 diabetes as Mounjaro, and in the indication of obesity as Zepbound, and Novo Nordisk's (NVO) semaglutide, marketed and sold in the same two indications as tirzepatide, as Ozempic, and Wegovy. The mechanism of action of these drugs allows them to interfere with receptors in the brain which control how full a person feels, and as such, they have been found to have miraculous weight loss qualities - tirzepatide achieving ~21% mean weight loss in patients in a pivotal study in obesity, and semaglutide achieving ~15%. As many people will be aware, these two drugs are expected to largely dominate an obesity treatment market that Wall Street believes can grow >$130bn per annum in size by 2030, and have underpinned astonishing gains in the share prices of Eli Lilly and Novo - both are up ~250% on a 3-year basis. Rezdiffra does not have the same weight loss qualities as the GLP-1 agonist class of drugs, and the market's fear has been that tirzepatide / semaglutide will soon gain approval in the field of NASH treatment, and \"eat Rezdiffra's lunch\" - after all, how can a company with no prior experience in commercial markets take on the world's two largest pharmaceutical companies and a \"miracle\" drug class with peak sales expectation of >$130bn per annum? In reality, however, the situation may be a little more nuanced than that, and the odds arguably not as heavily stacked against Rezdiffra / Madrigal as many analysts believe. For example, semaglutide has, in fact, flunked a Phase 2, 71 patient study in NASH according to data published in the Lancet in 2023, failing to significantly improve fibrosis or achievement of NASH resolution versus placebo. Tirzepatide has admittedly had much more success - Lilly reported positive data from a 190 patient NASH study just a few days ago as follows:  The efficacy estimand showed 51.8%, 62.8% and 73.3% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology compared to 13.2% of participants on placebo at 52 weeks of treatment, meeting the study's primary endpoint. In a secondary endpoint, the efficacy estimand showed 59.1%, 53.3% and 54.2% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved a 1-stage or greater fibrosis improvement without worsening of MASH compared to 32.8% of participants on placebo.  In Madrigal's pivotal MAESTRO study, ~29% of patients using the highest dose achieved NASH Resolution (according to an approval presentation), versus 9% of the placebo arm, and 27% achieved fibrosis improvement, versus 16% on placebo. Arguably, Lilly's data looks superior, but we should qualify that by noting Madrigal's study was far larger, with >850 patients compared to Lilly's 157, and the placebo response significantly different. It is rarely a good idea to directly compare two different clinical studies, as patient populations may also be significantly different, and the studies powered for different endpoints. For example, a co-moderator of Lilly's study was quoted in Medscape as stating: In terms of fibrosis, the results look numerically strong but are somewhat more puzzling to interpret, as there was no dose-response relationship and no data on NITs [noninvasive tests] that could support the results,\" he added. Patients with no-end-of-treatment biopsies were handled differently than in previous trials, which makes it difficult to appreciate antifibrotic potency. The moderator added that \"such a strong effect on MASH should translate into a reduction in fibrosis,\" but Lilly has admitted the study was not powered to test the fibrotic effect. Therefore, this would need to be established in a pivotal study, with liver biopsies conducted in every patient, potentially, which could take a number of years. Yesterday, Madrigal stock was buoyant, gaining 15% for the day, as analysts at Wolfe Research initiated coverage with an outperform rating, noting that prior authorization requirements to prescribe the drugs were \"benign\" - for example, a liver biopsy may not be necessary according to at least two major insurers - that Lilly's tirzepatide faced challenges proving its mettle in fibrosis reduction, and that Rezdiffra's closest challenger in terms of approvable data, Akero Therapeutics (AKRO) efruxifermin, may not win approval for another four years. More (Pragmatic) Reasons To Be Cheerful On Madrigal's Rezdiffra Prospects After securing accelerated approval for Rezdiffra, Madrigal moved quickly to complete a $690m fundraising, at $260 per share, giving the company a cash position of $1.1bn as of the end of Q1 2024 - a substantial war chest with which to fund its commercial push into a field in which it has no current competitors. In September last year, Madrigal appointed Bill Sibold as its new CEO. Sibold was formerly Executive Vice President, Specialty Care of French Pharma giant Sanofi (SNY) and President, Sanofi North America, where he played an instrumental role in the launch of Dupixent, an immunology drug that has gone on to earn ~$12bn of revenues in 2023. In short, Sibold has the commercial nous that Madrigal's mainly R&D focused team lacked, and has been charged with the successful launch of Rezdiffra. The new CEO appears to be relishing the challenge - while Madrigal understandably reported no Rezdiffra revenues in Q1, Sibold says his team has reached >80% of its top targets for physician education, who write 75% of all prescriptions, and has secured reimbursement coverage for 30% of covered lives so far, with the target being 80%. Madrigal cites independent, and its own, market research as suggesting physicians are enthusiastic about prescribing Rezdiffra - 75% of independent survey respondents said they expect to prescribe the brand (according to Madrigal's Q1 2024 investor presentation). At present, based on its label, Rezdiffra has a market opportunity of ~315k patients, Madrigal believes, and having set a list price of $47.4k per annum for the drug, there is a theoretical total addressable market (\"TAM\") opportunity of ~$15bn in play. Madrigal is conducting a further study, however, MAESTRO-NASH OUTCOMES, which, if successful, could expand Rezdiffra's label to NASH patients with cirrhosis, doubling the market opportunity, according to CEO Sibold (speaking on the Q1 2024 earnings call with analysts). Data from the study is due in 2026. Madrigal is also pushing for approval of Rezdiffra in Europe - Sibold told investors on the earnings call that \"we submitted Rezdiffra for approval in Europe, our MAA was validated, and we expect a decision in the first half of 2025.\" This also has the potential to substantially increase the addressable market. Finally, while we should not dismiss the threat of GLP-1 agonists, we should be cognizant of the fact that both semaglutide and tirzepatide are being affected by global supply shortages, with both Lilly and Novo scrambling to build more manufacturing plants to dope with demand. In that context, it is tempting to wonder if NASH is a genuine priority for Lilly, despite its promising results. It can already sell more tirzepatide than it can make in its existing two indications - is there a pressing need for the company to aggressively chase down approval in NASH as well? Concluding Thoughts - After A Surge In Share Price & Valuation, Does Madrigal Remain A Compelling \"Buy\" Opportunity? Madrigal Pharmaceuticals currently boasts a market cap of $6.22bn. Analysts have shared peak revenue expectations from ~$2.5bn by 2027, to $3.5bn, and many carry share price targets of >$375 per share, based on such figures. A quick scan of pharmaceutical companies generating ~$2 - $3bn in annual revenues in 2023 reveals that, for example, United Therapeutics (UTHR) enjoys a market cap valuation of >$12bn, BioMarin (BMRN) >$15bn, and Genmab (GMAB) >$18bn, DexCom (DXCM) >$40bn, and Alnylam, >$19bn. With a potential three or four more years of market exclusivity in play, and a drug that satisfies all criteria for successful treatment of a disease that can become life-threatening over time, and is an orally available drug, as opposed to an injectable like tirzepatide, with a strong safety profile, there do appear to be plenty of reasons to believe that Madrigal's share price may have substantially more upside to realize. Management has indicated that Q2 2024 will not be a revenue rich quarter, and that most sales will occur in the back end of 2024, so investors may need to be patient, and be prepared for Madrigal's share price to take hits if or when the likes of Lilly and Novo release later stage, positive NASH data. My own conviction is that Rezdiffra seems very likely to achieve blockbuster sales, and I think a figure of $3bn revenues per annum may be achievable before the end of the decade. Treatment of NASH is likely to vary from patients to patient, so irrespective of whether GLP-1's, or the Fc-FGF21 fusion proteins being developed by Akero, and 89bio (ETNB) make it to market, there will always be a call for various treatment options. With its recent fundraising and appointment of a CEO with genuine commercial knowhow, involved with one of the most successful drug launches recently, although it may have taken Madrigal longer than anyone believed possible to make it to market after sharing its Phase 2 data back in 2018, the company appears to be making up for lost time now. Under the right conditions, it may not be outlandish to suggest the company can challenge for a double-digit billion market cap within 2–3 years. Perhaps a more realistic target is a market cap rise >$7.5bn in 2024, which represents an attractive short-term gain of ~20%.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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