GLP - 1 therapies
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OneSource, Hikma get approval for generic Ozempic in Saudi Arabia
BusinessLine· 2026-02-11 05:18
OneSource Specialty Pharma has received Saudi Food and Drug Authority (SFDA) approval for its generic Ozempic (semaglutide) in Saudi Arabia, paving the way for its commercialisation with Hikma Pharmaceuticals PLC (Hikma), their exclusive partner for the Middle East and North Africa (MENA), the company said.The approval marks OneSource’s entry—a contract development and manufacturing organisation—into Saudi Arabia, one of the largest markets for GLP-1 therapies. The partnership aims to increase access to aff ...
Novo Nordisk Stock Whipsawed by GLP-1 Pill Fears: Relief Ahead?
ZACKS· 2026-02-09 15:56
Core Insights - Novo Nordisk's shares faced significant pressure due to a disappointing 2026 outlook, overshadowing a strong fourth-quarter performance [1] - Hims & Hers Health's announcement to launch a compounded oral semaglutide pill intensified competition in the weight-loss market, posing a threat to Novo Nordisk's flagship product, Wegovy [2][3] - The FDA's intervention against non-FDA-approved compounded GLP-1 drugs provided a temporary relief for Novo Nordisk's stock, which rebounded sharply [6] Company Performance - Novo Nordisk's stock has declined by 4.5% over the past six months, underperforming the industry growth of 34.5% [11] - The company's shares are trading at a price/earnings ratio of 14.31, lower than the industry average of 18.76 and significantly below its five-year mean of 29.25 [14] Market Dynamics - The obesity treatment market is becoming increasingly competitive, with Eli Lilly also advancing its GLP-1-based drugs and seeking approval for an oral GLP-1 pill [8] - The introduction of lower-priced alternatives, such as Hims' $49 compounded pill, raises concerns about pricing power and demand for Novo Nordisk's products [4][9] Regulatory Environment - The FDA has issued warnings against misleading marketing of compounded GLP-1 drugs, which could impact companies like Hims & Hers Health [6] - Novo Nordisk has indicated potential legal actions to protect its intellectual property and patient safety in response to the competitive threat [5] Earnings Estimates - Earnings estimates for Novo Nordisk have declined, with 2026 estimates dropping from $3.55 to $3.32 per share and 2027 estimates from $3.65 to $3.39 [17]
Analysts Project Eli Lilly (LLY) to Deliver 21%+ Revenue Growth and 40%+ Adjusted Earnings Growth in 2026
Yahoo Finance· 2026-02-08 15:26
Eli Lilly and Company (NYSE:LLY) is one of the 13 Best Extremely Profitable Stocks to Invest in Now. Analysts Project Eli Lilly (LLY) to Deliver 21%+ Revenue Growth and 40%+ Adjusted Earnings Growth in 2026 Pixabay/Public Domain On February 2, 2026, Reuters reported that long-standing expectations that the global obesity drug market would reach $150 billion over the next decade are being reconsidered amid declining U.S. prices for GLP-1 therapies and intensifying competition. The new projections indicat ...
How Will Mounjaro and Zepbound Sales Aid LLY's Upcoming Q4 Results?
ZACKS· 2026-01-15 16:21
Core Insights - Eli Lilly (LLY) has established a strong position in the cardiometabolic market, primarily due to the success of its GLP-1 therapies, Mounjaro and Zepbound, which generated $24.8 billion in sales, representing 54% of total revenues in the first nine months of 2025 [1][10] Group 1: Product Performance - Mounjaro and Zepbound's sales growth is attributed to improved domestic supply and expansion into new international markets, prompting Eli Lilly to raise its sales and earnings guidance twice in 2025 [2] - Sales estimates for Mounjaro and Zepbound for the upcoming quarter are projected at $6.55 billion and $3.62 billion, respectively, driven by stronger market penetration in the U.S. and international adoption [3] Group 2: Broader Portfolio Growth - Eli Lilly's portfolio, including oncology drug Verzenio and immunology drug Taltz, continues to show steady growth, with new launches like Omvoh, Ebglyss, Jaypirca, and Kisunla contributing to overall revenue [4] Group 3: Competitive Landscape - Eli Lilly and Novo Nordisk (NVO) are the leading players in the obesity market, with Mounjaro and Zepbound competing against NVO's semaglutide products, Ozempic and Wegovy [5] - Novo Nordisk received FDA approval for its oral Wegovy pill, enhancing its competitive edge, while Eli Lilly is seeking FDA approval for its own oral GLP-1 pill, orforglipron [6] Group 4: Market Dynamics - The obesity market is gaining attention due to its significant growth potential, with smaller biotech firms like Viking Therapeutics and Structure Therapeutics developing competing GLP-1 therapies [7][8] Group 5: Stock Performance and Valuation - Eli Lilly's stock has increased by 35.9% over the past six months, outperforming the industry average of 20.9% [11] - The stock is currently trading at a price/earnings ratio of 31.58, which is higher than the industry average of 17.86, but below its five-year mean of 34.56 [14] - Earnings estimates for 2025 have improved from $23.69 to $23.85 per share, and for 2026 from $32.06 to $33.25 [18]
Apyx Medical Corporation Reports Preliminary, Unaudited, Fourth Quarter and Full Year 2025 Revenue Results
Globenewswire· 2026-01-12 13:00
Core Viewpoint - Apyx Medical Corporation reported preliminary revenue results for Q4 and full year 2025, highlighting strong growth driven by the commercial launch of the AYON Body Contouring System and increased demand in the surgical aesthetics market [1][4]. Preliminary Fourth Quarter 2025 Revenue Summary - Total revenue for Q4 2025 is expected to be in the range of approximately $19.0 to $19.2 million, representing an increase of approximately 34% year-over-year [7]. - Surgical Aesthetics revenue for Q4 2025 is expected to be in the range of approximately $16.6 to $16.8 million, reflecting an increase of approximately 38% year-over-year [7]. - OEM revenue for Q4 2025 is expected to be approximately $2.4 million, indicating an increase of approximately 13% year-over-year [7]. Preliminary Full Year 2025 Revenue Summary - Total revenue for the full year 2025 is expected to be in the range of approximately $52.7 to $52.9 million, representing an increase of approximately 10% year-over-year [7]. - Surgical Aesthetics revenue for the full year 2025 is expected to be in the range of approximately $45.2 to $45.4 million, showing an increase of approximately 17% year-over-year [7]. - OEM revenue for the full year 2025 is expected to be approximately $7.5 million, reflecting a decrease of 21% year-over-year [7]. Industry Context - The commercial launch of AYON has generated immediate momentum, contributing to a strong fourth quarter performance, with a noted increase in aesthetic surgical procedures in the U.S. driven by the adoption of GLP-1 therapies leading to significant patient weight loss [4]. - The company is positioned to capitalize on the positive industry momentum in the surgical aesthetics market [4]. Company Overview - Apyx Medical Corporation specializes in surgical aesthetics, offering innovative products such as Renuvion® and the AYON Body Contouring System™ [5]. - The AYON Body Contouring System is an FDA-cleared, surgeon-designed platform that integrates various capabilities for comprehensive body contouring treatments [5]. - The effectiveness of Renuvion and J-Plasma is supported by over 90 clinical documents, showcasing the company's commitment to innovation in the cosmetic surgery market [5].
Pfizer Plays Catchup In Obesity Market, Licenses Weight-loss Drug From Fosun
Benzinga· 2025-12-18 11:58
Core Insights - Pfizer has acquired global rights to an oral weight-loss drug from Fosun Pharma, aiming to enhance its position in the competitive weight management market [1][4] - The collaboration is potentially valued at over $2 billion, highlighting the growing interest in innovative medications developed in China, particularly GLP-1 drugs [5][12] Group 1: Licensing Deal Details - Fosun Pharma's subsidiary, Yao Pharma, has granted Pfizer an exclusive worldwide license for the oral GLP-1 receptor agonist YP05002, which is still in early-stage development [6][8] - The deal includes an upfront payment of $150 million, with additional potential payments of up to $350 million tied to clinical and commercial milestones, and sales-related payments that could total $1.59 billion, leading to a maximum deal value of approximately $2.09 billion [7][12] Group 2: Market Context and Competition - GLP-1 therapies have become a significant focus for global pharmaceutical companies, with Novo Nordisk's semaglutide generating $25.46 billion in sales and Eli Lilly's tirzepatide achieving $24.84 billion in sales in the first three quarters of 2025 [10] - The oral version of GLP-1 drugs, like YP05002, could offer advantages over injectables, potentially improving patient compliance due to convenience [11] Group 3: Fosun Pharma's Performance - Fosun Pharma reported an 18.09% increase in revenue from innovative drugs in the first three quarters, despite an overall revenue decline of 4.91% to 29.39 billion yuan ($4.17 billion) due to price pressures in China's drug procurement [14] - The partnership with Pfizer is seen as a significant milestone in Fosun Pharma's strategy for innovation and internationalization, potentially enhancing its global market presence [15] Group 4: Future Outlook - Fosun Pharma's focus on innovative drugs is expected to drive growth, as it continues to divest non-core assets and allocate resources to research and development [16] - The company's current price-to-earnings ratio of around 17 times suggests potential for multiple expansion compared to other established Chinese drugmakers [16]
Eli Lilly and Company (LLY): A Bull Case Theory
Yahoo Finance· 2025-12-04 16:44
Core Thesis - Eli Lilly and Company (LLY) presents a compelling BUY opportunity due to its leadership in addressing major health issues, particularly obesity and Alzheimer's, despite a recent stock price decline [2][5] Financial Performance - As of November 28th, LLY's share price was $1,075.47, with trailing and forward P/E ratios of 52.69 and 33.90, respectively [1] - Mounjaro sales increased by 68% year-over-year, while Zepbound sales surged by 172%, indicating strong momentum in the company's weight loss drug segment [2] - The company has gross margins above 80% and EBITDA margins at 46.5%, reflecting high profitability [4] Market Position - LLY dominates the cardiometabolic health segment, which constitutes nearly 73% of its revenue, driven by GLP-1 therapies [3] - The U.S. market accounts for 67% of revenues, benefiting from new Medicare/Medicaid coverage for anti-obesity drugs, while Europe and Asia present growth opportunities [3] Industry Outlook - The global anti-obesity drug market is projected to exceed $95 billion by 2030, driven by rising obesity rates and chronic metabolic diseases [4] - Recent policy and regulatory changes enhance LLY's pricing power and market control, positioning the company favorably against competitors like Novo Nordisk [4] Valuation and Growth Potential - A DCF analysis indicates a three-year price target of $1,317 for LLY, supported by strong pipeline growth and industry tailwinds [5] - The company's scale, diversification, and strong R&D capabilities mitigate key risks such as policy shifts and macroeconomic factors [5]
As Eli Lilly Cuts Zepbound Prices, Should You Buy, Sell, or Hold LLY Stock?
Yahoo Finance· 2025-12-03 19:14
Core Insights - Eli Lilly and Company is a global pharmaceutical leader focused on areas such as diabetes, obesity, oncology, neuroscience, and immunology, known for landmark therapies and significant investment in R&D to meet unmet medical needs worldwide [1][5] Company Overview - Founded in 1876 by Colonel Eli Lilly, the company is headquartered in Indianapolis, Indiana, and operates in over 100 countries globally [2] Stock Performance - Eli Lilly's stock has shown strong performance in 2025, with a minor decline of approximately 7% over the past five days, a one-month gain of around 15%, a six-month rise of about 38%, and year-to-date gains exceeding 34% [3] - Compared to the S&P 500, which saw a 13% gain in the same period, Eli Lilly significantly outperformed with 52-week returns at 27% [4] Financial Performance - In Q3 2025, Eli Lilly reported revenue of $17.6 billion, up 54% year-over-year, surpassing analyst estimates [5] - Adjusted EPS reached $7.02, beating consensus forecasts by 16% to 19%, driven by volume growth from Mounjaro and Zepbound amid strong demand for GLP-1 therapies [5][6] - Gross margin improved to 82.9%, reflecting a favorable product mix despite pricing pressures, with U.S. revenue up 45% [6] Future Guidance - For full-year 2025, Eli Lilly raised its revenue guidance to $63 to $63.5 billion and adjusted EPS to $23 to $23.70, emphasizing sustained GLP-1 momentum and pipeline progress [7]
Can Lilly's Next-Gen Obesity Drugs Help Sustain Its Market Dominance?
ZACKS· 2025-11-14 15:02
Core Insights - Eli Lilly and Company (LLY) is a leading player in the diabetes and obesity market, primarily due to its GLP-1 therapies, Mounjaro and Zepbound, which utilize tirzepatide [1][2] - The obesity market is projected to reach $100 billion by 2030, intensifying competition among major players like Lilly and Novo Nordisk [2] - Lilly is actively developing new obesity treatments, including orforglipron and retatrutide, to maintain its competitive edge [3][10] Company Developments - Lilly is investing in a diverse range of obesity treatments, with several candidates in clinical development, including orforglipron, a daily oral GLP-1 medication, and retatrutide, a triple-acting incretin [3][4][7] - Positive data from six studies on orforglipron has been reported, with regulatory applications planned for later this year, potentially leading to a launch in 2026 [5][6] - Retatrutide is expected to provide significant weight loss benefits, with key phase III data anticipated from 2025 to 2027 [8][10] Competitive Landscape - The competition in the obesity treatment market is heating up, with other companies like Amgen and Viking Therapeutics also developing advanced GLP-1-based therapies [11][12] - Novo Nordisk has filed for an oral version of Wegovy and is advancing several next-generation candidates, which could challenge Lilly's market position [12][13] - Lilly's strategic investments in next-generation obesity treatments position it well to lead in innovation within the weight management sector [15] Financial Performance - Lilly's stock has increased by 32.6% this year, outperforming the industry average of 14.0% [16] - The current price/earnings ratio for Lilly is 33.37, significantly higher than the industry average of 16.73, although it is below its 5-year mean of 34.54 [18] - The Zacks Consensus Estimate for 2025 earnings per share has risen from $23.01 to $23.60, indicating positive market sentiment [20]
Lilly Up 18% in a Month: Should You Buy, Sell or Hold the Stock?
ZACKS· 2025-11-11 16:10
Core Insights - Eli Lilly and Company's stock has increased by 18% in a month, primarily due to strong third-quarter performance and price-cut agreements for GLP-1 therapies with the Trump administration [1][30] Financial Performance - Lilly reported solid third-quarter results, surpassing estimates for both earnings and sales, with key drugs Mounjaro, Zepbound, and Jardiance performing well [2] - The company raised its revenue expectations for 2025 from $60 billion to a range of $62 billion to $63.5 billion, and EPS expectations from $21.75-$23.00 to $23.00-$23.70 [3] Product Performance - Mounjaro and Zepbound have become significant revenue drivers, accounting for over 50% of total revenues, with Mounjaro sales at $6.52 billion (up 109% YoY) and Zepbound at $3.59 billion (up 185% YoY) in Q3 [5][6] - The cardiometabolic division is the strongest segment for Lilly, driven by the success of GLP-1 therapies [4] Pipeline and Future Growth - Lilly is expanding its obesity pipeline with several new molecules in clinical development, including orforglipron and retatrutide, which are expected to enhance sales further [8][10] - The company has also secured approvals for new therapies, contributing to revenue growth, including Omvoh and Kisunla [14][15] Market Competition - The obesity market is projected to reach $100 billion by 2030, leading to increased competition, particularly from Novo Nordisk and emerging candidates from other companies [16][18] - Lilly faces competition from other firms developing oral GLP-1-based treatments, which could impact its market share [17][19] Stock Performance and Valuation - Lilly's stock has outperformed the industry, rising 25.2% this year compared to the industry's 6.3% increase [20] - The stock is currently trading at a price/earnings ratio of 31.62, significantly higher than the industry average of 15.57, but below its 5-year mean of 34.54 [23] Analyst Sentiment - The Zacks Consensus Estimate for 2025 EPS has increased from $23.10 to $23.60, indicating a positive outlook from analysts [26] - Despite challenges, Lilly's strong product portfolio and growth prospects make it a favorable investment option [29]