Madrigal Pharmaceuticals: Eli Lilly's NASH Data Threatens Resmetirom's Potential

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Madrigal Pharmaceuticals is leading the race to secure approval for its drug Resmetirom to treat NASH, now known as MASH, a form of fatty liver disease.Eli Lilly's drug tirzepatide, which has already ...

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href=https://seekingalpha.com/article/4667987-madrigal-pharmaceuticals-eli-lillys-nash-data-threatens-resmetiroms-potential><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Madrigal Pharmaceuticals is leading the race to secure approval for its drug Resmetirom to treat NASH, now known as MASH, a form of fatty liver disease.Eli Lilly's drug tirzepatide, which has already ...</p>\n\n<a href=\"https://seekingalpha.com/article/4667987-madrigal-pharmaceuticals-eli-lillys-nash-data-threatens-resmetiroms-potential\">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":"LU2237438978.USD","symbol_name":"Amundi Funds US Pioneer A2 (C) 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market.Lilly's Phase 2 data for tirzepatide in NASH / MASH established the drug as a major threat to resmetirom.Resmetirom's peak revenue opportunity, once thought to be $5-$10bn, is now estimated to be ~$1bn by some analysts.Even that figure may prove hard to reach - Resmetirom's PDUFA date - when the FDA rules on whether to approve it for commercial use - arrives next month.   Daniel Christel/iStock via Getty Images Investment Overview Madrigal Pharmaceuticals (NASDAQ:MDGL), the Conshohocken, Pennsylvania based biotech, is the current leader of the \"NASH Dash\", that is, the race to secure a first approval for a drug developed to treat nonalcoholic steatohepatitis, or \"NASH\" an advanced form of non-alcoholic fatty liver disease (\"NAFLD\"), where buildups of fat in the liver begin to cause inflammation, fibrosis, followed by cirrhosis, which can cause life-threatening morbidities or necessitate a liver transplant. Nevertheless, the NASH treatment landscape has been shifting - in fact, the disease is no longer even referred as nonalcoholic steatohepatitis, or NASH, it is now referred to, as per a press release from the American Association for the Study Of Liver Diseases (\"AASLD\"), as \"MASH\":  Nonalcoholic fatty liver disease (NAFLD) will now be metabolic dysfunction-associated steatotic liver disease (MASLD). MASLD encompasses patients who have hepatic steatosis and have at least one of five cardiometabolic risk factors. A new category, outside of pure MASLD, termed MetALD (pronunciation: Met A-L-D) was selected to describe those with MASLD who consume greater amounts of alcohol per week (140 g/week and 210 g/week for females and males respectively). Those with no metabolic parameters and no known cause have cryptogenic SLD. Metabolic dysfunction-associated steatohepatitis (MASH) is the replacement term for nonalcoholic steatohepatitis (NASH).  Of far greater concern than a name change to Madrigal however - who expect to hear on the 14th March whether its \"MASH\" candidate Resmetirom, a proprietary, liver-directed, selective thyroid hormone receptor-ß (\"THR-ß\"), agonist taken orally, once daily, will be approved by the Food and Drug Agency (\"FDA\") - is the looming threat of a new type of all-conquering drug class, that is looking increasingly likely to derail Madrigal's carefully laid plans for the commercialisation of Resmetirom. The threat in question is tirzepatide, a drug developed by Eli Lilly (LLY), the world's largest Pharmaceutical company by market cap valuation, thanks largely to tirzepatide, which is a dual - that is GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) - hormone receptor activating, injectable therapy, that has secured two approvals, in the indications of Type 2 diabetes, under the brand name Mounjaro, and Obesity, under the brand name Zepbound. After Zepbound secured approval back in November last year, Lilly stock had reached a value of ~$600, up >450% across a five year period - almost unprecedented growth for a company in the \"Big Pharma\" sector - and it has continued to grow, reaching a value of $700 in trading today, as the company released its Q423 and FY23 earnings. Revenues grew to $9.4bn in Q4, up 28% year-on-year, with net income rising to $2.2bn, up 13% year-on-year. Mounjaro revenues grew to $5.2bn, shattering analysts' most optimistic forecasts, while Zepbound drove $176m of revenues barely a month after launch. Why Tirzepatide Threatens To Ruin Resmetirom's Coming Out Party As I discussed in a post on Madrigal for Seeking Alpha back in March last year, after releasing promising data from a Phase 2 study of Resmetirom in May 2018, Madrigal's share price rocketed to a value of $280, having traded at just $17 a few months prior, but after waiting almost four years for Phase 3 \"MAESTRO\" study data, the market had all but concluded the drug had flunked its pivotal study, and shares had sunk to <$65 in value, until Madrigal management announced otherwise at the end of December, 2022. The MAESTRO study met both of its primary endpoints, as determined by liver biopsy at 52 weeks of NASH resolution with ≥2-point reduction in NAS (NAFLD Activity Score), and with no worsening of fibrosis, OR a 1-point decrease in fibrosis with no worsening of NAFLD Activity Score (\"NAS\").   MAESTRO study results (Madrigal presentation) With a safety profile apparently comparable to placebo, the study data - when it was eventually released - made Resmetirom the leading candidate to win the newly termed \"MASH Dash\" and sent Madrigal's stock soaring back over $300 per share. The FDA accepted Madrigal's New Drug Application (\"NDA\") on September 13th last year, granting it a priority review, meaning the review period is shortened to six months as opposed to the standard nine months. There are ~1.5m people in the US suffering from MASH, and 525k diagnosed with MASH plus significant fibrosis, although Madrigal's initial target - according to an investor presentation - is the ~315k patients with MASH stages F2 or F3 - as per the National Institutes of Health: The stages of NASH-associated fibrosis range from absent (stage F0) to cirrhosis (stage 4), with stages F2-F4 considered to be clinically significant and stages F3-F4 considered to be advanced fibrosis Madrigal notes that the Institute for Clinical and Economic Review (\"ICER\"), which analyses drug pricing believes Resmetirom would prove cost effective at a cost of between ~$39k - $50k, so if take the midpoint of these two figures and multiply by 315k patients, we have an initial market opportunity in the region of ~$14bn, by my calculation. Even when shares were priced ~$300 , Madrigals' market cap did not exceed $5bn, which, given the prize on offer, may be considered a low value - particularly with no current competition in the marketplace. In the Pharmaceutical industry, there is always competition, however, and that was ok when Madrigal's competition consisted of a handful of >$1bn market cap biotechs - 89bio (ETNB), Akero Therapeutics (AKRO) and their fibroblast growth factor 21 (\"FGF21\") analog drugs, Intercept Pharma (ICPT), farnesoid X receptor (FXR) agonist Ocaliva, an drugs with a similar mechanism of action (\"MoA\") to resmetirom, developed by Viking Therapeutics (VKTX) and Terns Pharmaceuticals (TERN) to name a few. Madrigal's share price has begun to drift downward, however, ever since when it became clear that Eli Lilly was targeting MASH with its wonder drug Tirzepatide. Tirzepatide, alongside Novo Nordisk's semaglutide, another GLP-1 agonist, marketed and sold as Ozempic to treat Type 2 diabetes, and as Wegovy to treat obesity (with combined revenues of ~$12.5bn across the first nine months of 2023), has simply blown away expectations around what may can be achieved in the treatment of cardiometabolic diseases, and most notably, weight loss. In its pivotal study, tirzepatide - which mimics the action of incretin, a peptide hormone released after eating that targets receptors in the brain, making us feel more full - achieved weight loss in obese patients of 21% at the highest dose, while on the lowest dose, the figure was 15%. As Lilly (and Novo Nordisk's) inflated market cap suggests, peak sales of tirzepatide could reach >$50bn, it has been speculated. Besides obesity and diabetes, however, Lilly has also been running studies of its wonder drug in MASH, and today, announcing Q4 earnings, Lilly was able to announce: Positive results from SYNERGY-NASH, a Phase 2 study of tirzepatide in adults with nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), which met its primary endpoint where up to 74% of participants achieved an absence of MASH with no worsening of fibrosis at 52 weeks, compared to nearly 13% of participants on placebo. These results appear to be superior to the 30% MASH clearance achieved by resmetirom, although clinical trials are never directly comparable - in this case, Lilly focused on overweight patients, whereas Resmetirom enrolled a wider variety of patients. Furthermore, Resmetirom appears to have a greater ability to reduce fibrosis, although Lilly has argued that its study was not geared towards analysing fibrosis, and that reduction in fat is likely to result in reduced inflammation, and therefore reduced fibrosis. Pressure Ramping Up On Resmetirom - But Drug Still Likely To Make It To Market First The threat of tirzepatide - and to a lesser extent semaglutide, which flunked a Phase 2 study in MASH last year, failing to significantly reduce fibrosis or NASH resolution versus placebo - has been putting pressure on Madrigal's share price, which had sunk to a low of ~$120 by October last year, although the upcoming PUFA date sparked a mini-revival, with shares rising to >$235, before today's news. It is arguably hard to see how Madrigal - even after completing a $500m public offering to aid a commercial launch, and appointing a new CEO, Bill Sibold, formerly Executive Vice President, Specialty Care of Pharma giant Sanofi (SNY) and President, Sanofi North America, who brings commercial experience - can take on the might of Lilly in a commercial setting, especially if, as looks likely, tirzepatide establishes itself as the \"best-in-class\" drug. As such, expectations for peak sales of Resmetirom have been tempered. Initially, some analysts have speculated that peak sales of Resmetirom could reach ~$5bn in the US, and $1.5bn in Europe, and given Resmetirom a 90% chance of being approved. Others have set a figure of ~$9bn, but recently, analysts at Mizuho set a peak sales target of $1bn per annum. All of this is bad news for Madrigal, which is more or less \"all-in\" on resmetirom, with no other pipeline assets of note. Adding to the company's problem is the threat posed by Viking Therapeutics, whose VK2809 drug candidate has shown a superior ability to reduce liver fat by 48% at the highest dose, versus Resmetirom's figure of 23%. The one major advantage that Madrigal and Resmetirom do maintain over the competition is the \"first-mover\" advantage, given tirzepatide has not yet entered a pivotal Phase 3 study, and VK2809 is also yet to enter a pivotal study. Concluding Thoughts - Will Madrigal Rue 4-Year Gap Between Release Of Phase 2 and 3 Results For Resmetirom? When reconsidering the investment case for Madrigal in light of the Lilly data, it is hard to be quite as optimistic about an inevitable large share price spike should resmetirom be approved next month, as seems likely. The market has been overwhelmingly positive on GLP-1 agonists, pushing Lilly's market cap valuation to >$665bn, despite the company guiding for ~$40.4bn - $41.6bn of revenues in 2023, a forward price to sales ratio of >16x, when the Big Pharma sector average is closer to ~5x. Nevertheless, were Resmetirom to achieve \"blockbuster\" revenues (>$1bn per annum), the company would arguably deserve a higher valuation than it enjoys today, although if we apply the Big Pharma sector average of 5x forward revenues, the uplift may not be much more than 25%, and blockbuster sales might be considered a best case scenario - the worst case being the drug is completely sidelined by the emergence of tirzepatide. As such, even with the approval catalyst in play, I would consider remaining on the sidelines, as a drug approval is not always a guarantee of share price upside - witness the recent approval of CRISPR Therapeutics (CRSP) and Vertex (VRTX) Casgevy, which despite offering a historic \"one and done\" cure for Sickle Cell Disease, failed to lift Crispr's share price, owing to doubts around patient uptake. This may be the difficult reality that Madrigal now faces - a share price under pressure amid a remote prospect of blockbuster revenues while Lilly, despite its astronomical - by Big Pharma standards - valuation, could end up becoming the world's first ever $1 trillion dollar Pharma business. In a sentence I never thought I would write, the latter now seems more likely than the former (blockbuster sales for resmetirom.  Only time will tell, and tirzepatide still has hurdles to overcome before it can target approval in MASH / DASH, but Madrigal management must be rueing the delay in releasing its pivotal MAESTRO data, as not only has the NASH Dash been renamed, winning it is no longer the guarantee of triple digit share price returns it once was.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.26.4","shortVersion":"4.26.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2409251869"}