Investors are glued to Eli Lilly (LLY) shares this morning as the pharmaceutical behemoth became the world’s first trillion-dollar healthcare company. LLY has soared this year on the back of explosive demand for its obesity (Zepbound) and diabetes (Mounjaro) treatments, which together brought in over $10 billion in the company’s latest reported quarter. More News from Barchart At the time of writing, Eli Lilly stock is up a whopping 70% versus its low in early August. www.barchart.com How High Can Eli ...

What have been your key takeaways from your India roll out so far, and which strategic calls have worked for you in this market?One of the most important aspects to look at is the unmet need in India. There are nearly 100 million people living with obesity and diabetes who can potentially benefit from this medication.Coming to the launch of tirzepatide, a couple of things account for the success we've had to date. The first is the product itself. Tirzepatide (Mounjaro) offers a dual mechanism—it is the firs ...

Blood-thinning drugs that doctors often prescribe interchangeably after procedures to reopen narrowed heart arteries don't work equally well in patients with diabetes, a study from India found. ...

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its financial performance [5][21] - The guidance for top-line growth for 2025 has been narrowed to a range of 8%-11%, with corresponding adjustments to operating profit growth [21] Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from international operations (IO) and 24% from the U.S. [11] - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the U.S. [11] Market Data and Key Metrics Changes - The U.S. market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [12] - The company is currently addressing only 3-4 million patients in the obesity market, compared to an estimated 100 million potential patients [12] Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap of these conditions with other comorbidities [8][10] - The acquisition of Akero is part of the strategy to deepen its focus on metabolic diseases, particularly MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's commitment to expanding its product portfolio [9][14] - The company is preparing for the launch of oral semaglutide, which is expected to capture a significant portion of the market due to its unique profile [96][97] Other Important Information - The company is facing regulatory challenges regarding the Metsera acquisition, but remains confident in the quality of the portfolio and its potential [59][68] - There are ongoing discussions about the competitive landscape in the U.S. for GLP-1 products, with management noting a slight decline in Ozempic scripts but a belief in continued growth potential outside the U.S. [82][84] Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management indicated that they will not progress to phase III trials without clear differentiation in efficacy, safety, or scalability [25] Question: Can you explain the recent pricing trends for GLP-1 products? - Management confirmed that pricing for Ozempic is expected to decline by 10%-15% year-on-year, while Wegovy's pricing has also seen a decrease [27][28] Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of direct purchasing channels and expanding product offerings [31][36] Question: What is the outlook for revenue growth in 2026? - Management refrained from providing specific guidance for 2026 but highlighted the potential of the Wegovy pill launch and ongoing pipeline developments as future growth drivers [49][51] Question: What if the FTC blocks the Metsera acquisition? - Management expressed confidence in the acquisition's merits and readiness to discuss its benefits with the FTC [56][59] Question: Are there any supply limitations for the oral semaglutide? - Management reassured that there are no anticipated supply limitations for the oral semaglutide launch [101]

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its R&D pipeline and business development activities [4][20]. - The guidance for top-line growth for 2025 has been narrowed to a range of 8-11%, with corresponding adjustments to operating profit growth [20]. Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from International Operations (IO) and 24% from the US [10]. - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the US [10]. Market Data and Key Metrics Changes - The US market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [11]. - The company is addressing a market of approximately 100 million patients in the US for obesity treatment, with only 3-4 million currently being treated [11]. Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap with comorbidities such as MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [6][7]. - Recent acquisitions, including that of Akero, are aimed at deepening the company's focus on core therapy areas and addressing unmet needs in comorbidities associated with obesity and diabetes [7][15]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's strategic focus on expanding its product portfolio [11][13]. - The company acknowledged challenges in the US market, including pricing pressures and competition, but remains committed to leveraging its pipeline and product offerings to drive future growth [20][49]. Other Important Information - The company is preparing for the regulatory submission of new products, including the oral semaglutide and MyMADE for rare diseases, which are expected to contribute to future revenue growth [19][50]. - Management emphasized the importance of understanding patient behaviors and needs in the consumer market, particularly in relation to comorbidities and treatment formats [35][100]. Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management stated that they will not progress to phase three without clear differentiation in efficacy, safety, or scalability, and they are awaiting confirmation from phase two data [23]. Question: What are the pricing trends for GLP-1 medications? - Management indicated that pricing for Ozempic is expected to remain stable, with a year-on-year decrease of about 10-15%, while Wegovy's pricing has seen a decline in Q3 [26][27]. Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of product formats and direct purchasing channels [30][35]. Question: What is the outlook for the UK market? - Management noted that the UK market is competitive and price-sensitive, but they are seeing strong performance from their products despite pricing pressures [43]. Question: Can you discuss the Metsera acquisition and potential FTC challenges? - Management expressed confidence in the acquisition's merits and their readiness to discuss it with the FTC, emphasizing the quality of the portfolio [52][56]. Question: What is the expected impact of the oral semaglutide launch? - Management believes that the oral market represents a significant opportunity, with expectations of capturing a substantial share due to its unique profile [95][100].

The Multibillion-Dollar Battle For Metsera’s Obesity DrugsLearn how the battle between Novo Nordisk and Pfizer over Metsera, a three-year-old company working on treatments for obesity and diabetes, escalated this week. https://t.co/k1NQKNo2LG ...

Core Insights - Biomea Fusion, Inc. presented two late-breaking posters at ObesityWeek® 2025, showcasing preclinical data for its investigational drugs BMF-650 and icovamenib [1][2] Group 1: BMF-650 - BMF-650 is an oral small-molecule GLP-1 receptor agonist currently in Phase I study, with 28-day weight loss data expected in the first half of 2026 [5] - In preclinical studies, BMF-650 demonstrated potent weight loss effects, achieving a 12-15% body weight reduction in obese cynomolgus monkeys after 28 days of daily oral dosing [8] - The drug showed strong oral bioavailability of 33% in rats and 54% in monkeys, exceeding that of orforglipron under matched conditions [8] Group 2: Icovamenib - Icovamenib, a covalent menin inhibitor, was tested in combination with low-dose semaglutide in ZDF rats, showing superior weight loss and glycemic control compared to semaglutide alone [7] - The combination treatment resulted in a 60% lower fasting blood glucose compared to semaglutide alone and a greater improvement in insulin sensitivity, with a 75% lower HOMA-IR [9] - Clinical evaluation of icovamenib is set to begin in T2D patients currently on GLP-1 based treatment, with the first patient expected to be dosed in the first quarter of 2026 [10] Group 3: Company Overview - Biomea Fusion focuses on developing oral small molecule therapies for diabetes and obesity, targeting metabolic disorders affecting a significant portion of the global population [13] - The company's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [13]

Core Insights - Biomea Fusion, Inc. has made significant advancements in its diabetes and obesity programs, particularly with icovamenib showing durable results in a 52-week Phase II study and BMF-650 entering Phase I clinical trials [1][5][8] - The company raised approximately $68 million through public offerings, extending its cash runway into the first quarter of 2027 [1][6] Icovamenib Developments - Icovamenib, an oral small molecule menin inhibitor, demonstrated a sustained 1.5% mean reduction in HbA1c at Week 52 in patients with severe insulin-deficient diabetes [5] - The drug was well tolerated, with no serious adverse events reported during the 52-week observation period [5] - Preclinical data presented at the EASD Annual Meeting showed enhanced glycemic control and body weight reduction when icovamenib was combined with semaglutide in a T2D animal model [5] BMF-650 Progress - BMF-650, a next-generation oral small molecule GLP-1 receptor agonist, has dosed its first patient in a Phase I study, which will evaluate its weight loss potential in obese volunteers [1][4][8] - Preclinical findings indicated that BMF-650 led to significant reductions in food intake and body weight in obese nonhuman primates [5] Financial Performance - For Q3 2025, Biomea reported a net loss of $16.4 million, a decrease from a net loss of $32.8 million in Q3 2024 [11][12] - Research and development expenses were $14.4 million for Q3 2025, down from $27.2 million in the same period of 2024, reflecting a year-over-year decrease of over 50% in operating expenses [11][12] - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $47 million [11][19] Key Milestones - The initiation of Phase IIb trial (COVALENT-211) in severe insulin-deficient T2D patients is expected in Q4 2025, with the first patient expected to be dosed in Q1 2026 [10] - The ongoing Food Effect Study (COVALENT-121) aims to optimize dosing criteria for icovamenib and is expected to be completed by December 2025 [10]

Core Insights - Mounjaro has rapidly become the highest-selling drug in India, with total sales reaching Rs 450 crore by October, significantly outperforming its competitor Wegovy, which only achieved Rs 28 crore since its launch in June [3][21][22] - The drug's success is attributed to effective marketing strategies, superior patient experience, and timely market entry, as it was launched three months ahead of Wegovy [2][10][21] - Globally, Mounjaro's sales have reached $24.8 billion year-to-date, surpassing Merck's Keytruda [6][21] Sales Performance - Mounjaro's cumulative sales in India were Rs 235 crore by September, indicating strong market acceptance since its launch [3][21] - The drug's sales are driven by direct sourcing from allied specialties, which has led to higher actual sales than reported prescriptions [9][22] Marketing Strategy - Eli Lilly's decision to launch Mounjaro in vials rather than waiting for pen supplies allowed for a cost-effective trial for patients, enhancing initial uptake [10][11][12] - The repositioning of Mounjaro as a weight-loss therapy rather than a diabetes drug has improved its acceptance among consumers in India [17][22] Competitive Landscape - Mounjaro has a weight-loss efficacy of 20-22%, compared to Wegovy's 16-18%, contributing to its competitive edge [16][22] - Executional gaps in Novo Nordisk's rollout of Wegovy, including frequent changes in salesforce and limited local partnerships, have hindered its market penetration [18][19][22] Future Outlook - Experts predict that Mounjaro's growth may plateau with the anticipated entry of cheaper generics of semaglutide (Wegovy) into the Indian market by early 2026 [19][20][22] - While Mounjaro currently leads in market share, the long-term impact of generics and the stronger cardiovascular data associated with semaglutide may influence prescribing trends [20][22]

Core Insights - Eli Lilly reported adjusted earnings of $7.02 per share on $17.6 billion in third-quarter sales, exceeding analyst expectations of $5.89 per share and $16.05 billion in sales [1][2] - The company experienced significant growth in sales for its diabetes treatment Mounjaro, which generated $6.52 billion, and Zepbound, a weight-loss drug, which brought in $3.59 billion, both surpassing analyst projections [2] - Eli Lilly raised its full-year guidance, now expecting adjusted earnings of $23-$23.70 per share on sales of $63 billion-$63.5 billion, compared to the Street's expectations of $22.48 earnings per share and $61.74 billion in sales [2] Stock Performance - Eli Lilly's stock rose 3.9% to 845 in premarket trading, with a short-term high of 864.35 identified as a potential entry point for investors [3] - The stock is currently trading above key moving averages, although it has a low IBD Digital Relative Strength Rating of 33, indicating it ranks in the bottom third of stocks based on 12-month performance [3]