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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]
Apogee Therapeutics(APGE) - 2025 FY - Earnings Call Transcript
2025-12-03 15:45
Financial Data and Key Metrics Changes - The company anticipates 2026 to be a transformative year with important clinical readouts, including data points for their lead program 777 in atopic dermatitis (AD) and asthma [5][6] - The market for atopic dermatitis is expected to grow at approximately 25% annually, indicating a significant opportunity for the company [40][58] Business Line Data and Key Metrics Changes - The company is focusing on the biologic penetration in the AD space, which is currently around 10%, significantly lower than other inflammatory diseases, presenting a large opportunity for growth [11][30] - The company plans to test both lower and higher doses in their Part B trial to optimize dosing strategies for their product 777 [14][35] Market Data and Key Metrics Changes - The asthma market is also underpenetrated, with significant growth potential, and the company expects to leverage its existing presence in allergist offices to expand into this market [40][47] - The company is looking to achieve a FeNO reduction of 15-20 parts per billion in their asthma trials, which would be competitive with existing treatments [37][45] Company Strategy and Development Direction - The company aims to be a serial innovator in atopic dermatitis, focusing on establishing a strong foundation before expanding into other indications [53][56] - The strategy includes launching with monotherapy and following up with combination therapies to address broader patient populations [42][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product profile of 777, highlighting its preferred status among physicians and patients, which is expected to facilitate favorable payer access [60][61] - The company believes that the AD market needs new options, as many patients do not achieve satisfactory results with existing treatments, indicating a strong demand for their product [59][62] Other Important Information - The company is preparing for a phase 3 trial by the end of 2026, with plans to include biologic experienced patients to better understand the market dynamics [32][35] - The company is also exploring combination therapies to enhance efficacy and address diverse drivers of diseases like asthma and COPD [42][46] Q&A Session Summary Question: What are the opportunities for differentiation in the Part B study? - The company aims to replicate strong data from Part A and test a dose-response curve to optimize dosing strategies [13][14] Question: What challenges exist in moving to less frequent dosing? - The company has confidence in their pharmacokinetic modeling and plans to adjust dosing based on efficacy observed in trials [19][20] Question: How does the company plan to secure payer access? - The company believes that strong physician preference and patient need for new options will facilitate favorable access with payers [60][61] Question: What is the expected market landscape by the time 777 launches? - The market is expected to continue growing, with new-to-brand prescriptions increasing significantly, indicating a robust opportunity for the company [57][58]
Beyond GLP-1: Eli Lilly's Expanding Drug Portfolio Lifts Sales
ZACKS· 2025-11-20 13:06
Core Insights - Eli Lilly and Company's stock reached $1000 per share for the first time on November 12, indicating strong market performance and nearing a $1 trillion market cap, primarily driven by the success of GLP-1 drugs like Mounjaro and Zepbound [1][8] Drug Approvals and Revenue Contributions - Lilly has received approvals for several new drugs, including Omvoh, Jaypirca, Ebglyss, and Kisunla, which are contributing to revenue growth alongside GLP-1 drugs [2][5] - In the first nine months of 2025, Omvoh generated $176.9 million, while Ebglyss, Kisunla, and Jaypirca contributed $274.1 million, $140.6 million, and $358.2 million, respectively, totaling $950 million from these new drugs [3][10] Ongoing Studies and Future Potential - New drugs are being evaluated for additional indications, with Ebglyss in phase III trials for chronic rhinosinusitis and Jaypirca being studied for broader use in CLL and MCL [4][8] - Lilly anticipates launching new drugs in the fourth quarter of 2025 and throughout 2026, which will further enhance revenue [5][8] M&A Strategy - To diversify its portfolio beyond GLP-1 drugs, Lilly is pursuing M&A opportunities in cardiovascular, oncology, and neuroscience sectors, including the acquisition of Verve Therapeutics and Adverum Biotechnologies [6][7] Competitive Landscape - Omvoh faces competition from AbbVie’s and J&J’s products, while Kisunla competes with Eisai/Biogen's Leqembi, and Jaypirca competes with older BTK inhibitors [9][11] Stock Performance and Valuation - Lilly's stock has increased by 35.8% this year, outperforming the industry average of 14.4% [12] - The stock trades at a price/earnings ratio of 33.83, significantly higher than the industry average of 16.84, but below its 5-year mean of 34.54 [14] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has risen from $22.94 to $23.78, and for 2026 from $30.79 to $32.06 over the past 30 days [16]
Apogee Therapeutics (NasdaqGM:APGE) Conference Transcript
2025-11-13 18:30
Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Date**: November 13, 2025 - **Key Speakers**: Michael Henderson (CEO), Carl Dambkowski (CMO), Jeff Hartness (CCO), Jane Pritchett Henderson (CFO) Key Industry and Company Insights Asthma Data and APG777 - **APG777 Phase 1 Readout**: Expected in Q1 2026, focusing on asthma data [2][4] - **Comparison with Ebglyss**: Ebglyss failed due to underdosing (20% of effective dose) and lack of targeting type 2 disease [2][3] - **Targeting Type 2 Disease**: Apogee aims to enroll high FeNO patients, expecting a change in FeNO similar to Dupixent (15-20 parts per billion) [3][4] - **Loading Dose**: APG777 will use a loading dose of 720 mg, compared to Ebglyss's 500 mg [5][7] Future Plans in Asthma - **Expansion Plans**: If successful, Apogee plans to initiate Phase 2B studies in asthma and EoE, contingent on atopic dermatitis data [8][9] - **Overlap with Atopic Dermatitis**: Approximately 30% overlap between atopic dermatitis and asthma patients [9] Atopic Dermatitis Phase 2 Program - **Part A Results**: Positive results reported, with 52-week maintenance data expected in Q1 2026 [10][11] - **Success Metrics**: Aiming for maintenance of EC75 response at week 52, with a benchmark of 72% for Dupixent [11][12] - **Dosing Strategy**: Plans for every three-month and six-month dosing regimens, with data expected to inform Phase 3 studies [12][13] Mechanistic Insights - **Differentiation from Competitors**: APG777 targets IL-13 and IL-4 receptors, potentially leading to better durability of response compared to competitors [16][17] Part B Study Design - **Dose Optimization**: Part B will explore three doses versus placebo, aiming to fully understand the dose-response curve [19][20] - **Market Research**: Positive feedback from physicians, with 60% preferring APG777 over competitors [37][38] Market Positioning - **Market Disruption Potential**: Ebglyss and Nemluvio are currently strong competitors, but Apogee believes it can capture significant market share [38][39] - **Combination Therapy**: Plans to explore combinations with APG990, aiming for additive efficacy [32][33] Financial Position - **Cash Reserves**: Apogee has $913 million in cash, providing a runway into the second half of 2028 [30] Timeline for Future Trials - **Phase 3 Trials**: Expected to start next year, with a potential market launch in 2029 [27] Additional Insights - **Conjunctivitis Rates**: Lower rates observed in higher exposure groups, aligning with Dupixent's data [26] - **Combination with TSLP**: Future plans to explore combinations with TSLP based on upcoming data [41][44] Conclusion Apogee Therapeutics is positioned to make significant advancements in the treatment of asthma and atopic dermatitis with its APG777 product. The company is focused on differentiating its therapies through targeted dosing and mechanistic advantages, while also preparing for future market competition and expansion into additional indications.
Apogee Therapeutics (NasdaqGM:APGE) FY Conference Transcript
2025-11-11 19:30
Summary of Apogee Therapeutics FY Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Industry**: Biopharmaceuticals, specifically focusing on antibody development for various indications including atopic dermatitis, asthma, and other conditions Core Strategy and Differentiation - Apogee is focused on developing best-in-class antibodies targeting large markets, with a lead program being a fully optimized IL-13 antibody for atopic dermatitis [4][5] - The company aims to improve dosing and efficacy through both monotherapies and combination approaches, with a goal of three to six-month dosing and optimized efficacy [5][6] - Apogee plans to initiate phase three trials next year, positioning itself ahead of competitors in the market [7][8] Market Dynamics and Competitive Landscape - The atopic dermatitis biologic market is growing at over 25% annually, with new-to-brand prescriptions increasing by 49% year-over-year [10][11] - Current biologic penetration in atopic dermatitis is only about 10%, indicating significant growth potential compared to other conditions like plaque psoriasis (25-30% penetration) and inflammatory bowel disease (60% penetration) [11] - Recent launches of competitors like Nemluvio and Ebglyss have shown promising sales, with Nemluvio annualizing at $500 million and Ebglyss at $650 million in their first year [10] Payer Environment and Access - Payers are providing first-line access to new biologics, with Nemluvio and Ebglyss achieving 80% and 90% coverage, respectively [13][14] - Apogee anticipates that its product will be preferred by both physicians and patients, driving prescription volume and payer access [14] Clinical Data and Product Development - Apogee's lead asset, APG 777, has shown promising phase 2a data, with a higher response rate (EASI 75) compared to competitors [16][17] - The company is exploring both three-month and six-month dosing regimens, with plans to gather data to inform phase three trials starting in the second half of 2026 [22][23] - The company is also investigating the efficacy of APG 777 in asthma, with a focus on FeNO as a biomarker for response [27][28] Combination Therapies and Future Directions - Apogee is developing combination therapies with TSLP and OX40L, aiming for co-formulation to enhance dosing frequency and efficacy [31][32] - The company is cautious about the crowded landscape for TSLP therapies and is focusing on combination approaches rather than monotherapy [30][31] - Apogee's strategy includes running active comparator studies to establish its products as frontline therapies [36][37] Conclusion - Apogee Therapeutics is positioned for a busy 2026 with multiple catalysts on the horizon, including phase three trials and potential product launches [40]
Lilly Beats on Q3 Earnings, Ups View, Mounjaro, Zepbound Drive Sales
ZACKS· 2025-10-30 18:01
Core Insights - Eli Lilly and Company (LLY) reported third-quarter 2025 adjusted earnings per share (EPS) of $7.02, exceeding the Zacks Consensus Estimate of $6.02 per share, and significantly up from $1.18 per share in the same quarter last year [1][9] - Revenues reached $17.60 billion, a 54% increase year over year, driven by strong sales of GLP-1 drugs, Mounjaro and Zepbound, surpassing the Zacks Consensus Estimate of $16.01 billion [2][9] Revenue and Sales Performance - Mounjaro sales were $6.52 billion, up 109% year over year, beating the Zacks Consensus Estimate of $5.48 billion [3] - Zepbound recorded sales of $3.59 billion, a 185% increase year over year, exceeding the Zacks Consensus Estimate of $3.45 billion [4] - Trulicity generated revenues of $1.05 billion, down 19% year over year, in line with estimates [6] - Jardiance sales rose 40% to $959 million, surpassing the Zacks Consensus Estimate of $687 million [6] - Taltz brought in sales of $901.5 million, up 2% year over year, but missed the Zacks Consensus Estimate [7] - Verzenio generated sales of $1.47 billion, up 7% year over year, but also missed estimates [7] - Emgality revenues were $175.7 million, down 13% year over year, while Olumiant sales were $268.9 million, up 7% [8] Market Dynamics and Competition - Mounjaro and Zepbound are gaining market share from Novo Nordisk's Ozempic and Wegovy, despite facing strong competition [5] - The company is investing in obesity treatments and has several new molecules in clinical development, including orforglipron and retatrutide [14] Guidance and Future Outlook - Lilly raised its 2025 revenue guidance to $63.0 billion to $63.5 billion, up from a previous range of $60.0 billion to $62.0 billion, and increased EPS guidance to $23.00 to $23.70 [11][13] - The company is expanding its portfolio beyond GLP-1 drugs into cardiovascular, oncology, and neuroscience areas, with recent acquisitions to enhance its pipeline [17][18] Stock Performance - Following the strong third-quarter results and guidance increase, Lilly's shares rose more than 5% in pre-market trading, with a year-to-date increase of 5.3% compared to the industry average of 3.3% [13]
Lilly(LLY) - 2025 Q3 - Earnings Call Presentation
2025-10-30 14:00
Financial Performance - Total revenue reached $17601 million, a 54% increase compared to Q3 2024[12, 17] - Key product revenue grew by 104%, reaching $12 billion[12] - Non-GAAP earnings per share (EPS) increased by $584 to $702[12] - The company raised the midpoint of full-year revenue guidance by over $2 billion[10] Product Highlights - Lilly's U S incretin analogs market share increased to 579% of total prescriptions, with market growth of 36% versus prior year[10, 26] - Mounjaro U S sales were $36 billion, and international sales were $30 billion[56] - Zepbound U S sales were $36 billion, and international sales were $20 million[59] - Verzenio U S sales were $880 million, and international sales were $590 million[62] - Jaypirca Q3 2025 sales were $143 million, with U S TRx increasing 61% vs Q3 2024[24] - Ebglyss Q3 2025 sales were $127 million, with U S TRx growing 41% vs Q2 2025[24] - Omvoh Q3 2025 sales were $65 million[24] - Kisunla Q3 2025 sales were $70 million[24] Strategic Investments - Year-to-date capital investments totaled $53 billion[12] - Research & Development investment was $35 billion, representing 27% of revenue[12] - Marketing, selling & administrative expenses were $27 billion, a 31% increase[12] - $13 billion was distributed via dividends and $07 billion in share repurchases[14] Regulatory and Clinical Updates - Inluriyo (imlunestrant) received U S FDA approval for ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer[11] - Kisunla received marketing authorization in Europe for early symptomatic Alzheimer's disease[11] - Orforglipron showed positive results in four additional Phase 3 trials[11] - Jaypirca significantly improved progression-free survival in treatment-naïve CLL/SLL[11]
Guggenheim Initiates Rapt Therapeutics With Buy Rating and $70 Price Target
Financial Modeling Prep· 2025-10-27 20:57
Core Viewpoint - Guggenheim initiated coverage of Rapt Therapeutics Inc. with a Buy rating and a $70 price target, driven by optimism regarding the company's lead anti-IgE antibody program and growth potential in the food allergy treatment market [1] Company Highlights - Rapt's long-acting anti-IgE monoclonal antibody, RPT-904, is highlighted as a key differentiator, featuring a YTE mutation that extends its half-life to approximately three times that of Roche's Xolair, the first-generation anti-IgE treatment recently approved for food allergies [2] - RPT-904 is expected to provide a significant convenience advantage due to its less frequent dosing, which is particularly beneficial for the pediatric population, as most food allergy patients are children [3] Market Potential - Guggenheim estimates that RPT-904 could address 20–30% of the patient population currently ineligible for Xolair due to high IgE levels or weight restrictions [4] - A Phase IIb trial with around 100 participants is anticipated to start in 2026, with data expected in the first half of 2027 [4] - If approved, peak sales for RPT-904 in food allergy indications are projected to be approximately $2.1 billion, indicating substantial upside potential given Rapt's enterprise value near $765 million [4]
What's in Store for These 5 Pharma Bigwigs This Earnings Season?
ZACKS· 2025-10-27 16:06
Core Insights - The third-quarter 2025 reporting cycle for the Medical sector is commencing, with major firms expected to release earnings results in the coming weeks, particularly in pharma/biotech and medical devices [1] - Johnson & Johnson has set a positive tone for the earnings season by exceeding estimates and raising its sales expectations for 2025 [1] - Roche has reported solid growth in the first nine months of 2025, driven by high demand for key drugs, leading to an upward revision of its earnings per share growth expectations for 2025 [2] Earnings Trends - As of October 22, 13.3% of Medical sector companies, representing 26.8% of the sector's market capitalization, have reported earnings, with 87.5% exceeding earnings estimates and the same percentage surpassing revenue expectations [3] - Year-over-year earnings increased by 7.4%, while revenues rose by 9.8%. However, third-quarter earnings for the Medical sector are projected to decrease by 4.3%, with sales expected to rise by 8.1% compared to the previous year [3] Company Performance Expectations - Eli Lilly is expected to report strong results driven by demand for GLP-1 drugs and other oncology and immunology products, with a consensus estimate of $16.01 billion in sales and $6.02 per share in earnings [7][8] - Merck is anticipated to see growth from its cancer drug Keytruda, with estimates of $17.06 billion in sales and $2.36 per share in earnings [12] - AbbVie is projected to benefit from sales of Rinvoq, Skyrizi, and newer drugs, with estimates of $15.59 billion in sales and $1.80 per share in earnings [13][14] - Bristol Myers is expected to report revenues influenced by growth portfolio sales, with estimates of $11.83 billion in sales and $1.51 per share in earnings [15][16] - Gilead Sciences is likely to see revenue support from its HIV therapies, with estimates of $7.46 billion in sales and $2.15 per share in earnings, although impacted by changes in Medicare Part D [19][20]
Lilly Up 10% in a Month: Should You Buy, Sell or Hold the Stock?
ZACKS· 2025-10-23 15:40
Core Insights - Eli Lilly and Company's stock has increased by 9.5% in a month, driven by a recovery in the pharma sector, with major players like Pfizer and AstraZeneca entering drug pricing agreements with the Trump administration [1][2][11] Company Performance - Lilly's top line is significantly supported by the strong growth of its diabetes and obesity treatments, particularly the GLP-1 therapies Mounjaro and Zepbound, which together account for approximately 50% of the company's total revenues [4][5][11] - The company has committed over $50 billion for domestic manufacturing expansion, positioning itself for potential agreements with the U.S. government similar to those signed by Pfizer and AstraZeneca [2][11] Product Pipeline - Lilly is actively investing in its obesity pipeline, with several new molecules in clinical development, including orforglipron and retatrutide, which are expected to enhance its market position [7][8][9] - The company has received approvals for multiple new therapies, including Omvoh, Jaypirca, Ebglyss, and Kisunla, contributing to revenue growth [12][13] Market Dynamics - The obesity market is projected to reach $100 billion by 2030, leading to increased competition, particularly from Novo Nordisk, which poses a challenge for Lilly's Mounjaro and Zepbound [14][18] - U.S. President Trump's indication of potential price cuts for GLP-1 drugs raises concerns about pricing pressures on Lilly's products, although formal negotiations have not yet begun [15][16] Financial Outlook - Lilly's stock is currently trading at a price/earnings ratio of 27.72, higher than the industry average of 15.54, but below its five-year mean of 34.54 [23][29] - The company anticipates revenues between $60 billion and $62 billion in 2025, reflecting a year-over-year growth of over 30% [29]