Tag Archives: obesity

Lilly Raises 2024 Guidance on Strong Mounjaro/Zepbound Performance; Lilly Q1 ’24 Earnings Update

Lilly hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Lilly raised its FY revenue guidance by $2.0B to $42.4B – $43.6B, primarily due to the strong performance of Mounjaro and Zepbound. Below, FENIX provides highlights and insights from the call, including thoughts on Lilly’s strategy to develop oral formulations for tirzepatide and retatrutide.

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Lilly Initiates Retatrutide CV and Renal Outcomes Study; Novo Initiates New Ph3 Cagrisema Maintenance Dose Study; US Senate Investigates Ozempic/Wegovy Pricing; Teladoc Q1 ’24 Earnings; Vance Swanson Joins Beta Bionics

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.

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Study on Eligible Wegovy Patients through Medicare; Roche Q1 ’24 Earnings

Two cardiometabolic-related news items have been observed: a recent study from Kaiser showed that approximately 3.6M overweight or obese patients with heart conditions insured under Medicare could be eligible for Wegovy (view article); and Roche hosted its Q1 ’24 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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Metsera Launches as Obesity Company; Lilly Initiates Ph2 Tizepatide+Mibavademab Obesity Trial; Skye Uplists to Nasdaq Global Market

Three cardiometabolic-related news items have been observed: Metsera announced its launch as an obesity company (view press release); Lilly initiated a Ph2 trial evaluating tirzepatide + mibavademab vs. tirzepatide monotherapy in obesity (view CT.gov record); and Skye Biosciences announced it received approval to list its common stock on the Nasdaq Global market stock exchange (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on the potential new obesity partnership between Lilly and Regeneron.

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Novo acquires Cardior Pharmaceuticals; Novo initiates Ph2 Dual Agonist Trials in T2DM and Obesity; Esperion CLEAR Outcomes Investor Call

Three cardiometabolic-related news items have been observed: Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for its heart failure asset (view press release); Novo initiated two trials evaluating its GLP-1/GIP dual agonist in obesity (view CT.gov record) and T2DM (view CT.gov record); and Esperion hosted an investor event to discuss the CLEAR Outcomes FDA approval (view presentation). Below, FENIX provides highlights and insights for the respective news items.

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Tirzepatide Obesity Indication Approved as “Zepbound” 

Lilly announced that FDA approved tirzepatide as “Zepbound” for adults with obesity or overweight that also have weight-related comorbidities such as hypertension, dyslipidemia, T2DM, OSA, or CVD (view label). Of note, FDA also made an announcement regarding the approval (view here). Tirzepatide remains under review in the EU, UK, China, and other markets. Lilly stated Zepbound is anticipated to be launched in the US by EOY 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg). In the press release, Lilly specifically disclosed the Zepbound WAC price of $1,059.87, which Lilly noted is 20% less expensive than Wegovy. FENIX will conduct a full label analysis of Zepbound in the coming days.

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FENIX Analysis: Thoughts on a Potential Zealand Acquisition

Following ADA 2023, FENIX conducted an analysis regarding a potential impending obesity development/commercialization partnership between two large pharma/biotech companies (view here); however, another compelling question has arisen: with all of the hype around the obesity market, has Zealand Pharma become a more attractive acquisition target? Below, FENIX provides insights and analysis for a potential Zealand acquisition by Boehringer Ingelheim, Novo Nordisk, AstraZeneca, or Amgen, as well as thoughts as to why Amgen could be the most likely suitor.

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SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. Below, FENIX provides highlights and insights from the call.

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New Non-invasive BGM; Amarin Updates Vascepa US Go-to-market Strategy; Welldoc Receives 510(k) Clearance for Bolus and Premixed Insulin Titration; CinFina Agreement with Janssen for QW Obesity Assets

A series of cardiometabolic-related news items have recently been observed: Know Labs announced the addition of KnowU, a portable Bio-RFID glucose monitoring device, to the company’s portfolio of non-invasive diagnostic technology; Amarin announced an update to its Vascepa go-to-market strategy, including US field force layoffs; Welldoc announced FDA 510(k) clearance for the BlueStar Insulin Adjustment Program for bolus and premixed insulin titration; and CinFina Pharma announced an agreement with Janssen Sciences Ireland Unlimited Company to acquire exclusive WW rights to four QW anorectic agents for the treatment fo obesity. Below, FENIX provides highlights and insights for the respective news items.

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