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Incyte Study Shows Lymphoma Drug Combo Slows Aggressive Blood Cancer
Benzinga· 2026-01-05 16:59
Incyte Corporation (NASDAQ:INCY) on Monday shared topline results from the pivotal Phase 3 frontMIND trial of tafasitamab (Monjuvi/Minjuvi) combo as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL).The trial evaluated tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) compared to R-CHOP alone.The trial met its primary endpoint of progression-free survival (PFS). The trial also met its key seco ...
Here’s Why Genmab A/S (GMAB) Rose in Q3
Yahoo Finance· 2025-12-31 13:43
Core Insights - Chautauqua Capital Management's third-quarter 2025 investor letter indicates that global equity markets performed well due to the resolution of trade conflicts and a dovish shift in U.S. monetary policy [1] - The Baird Chautauqua International Growth Fund and the Baird Chautauqua Global Growth Fund both underperformed their respective benchmarks, primarily due to poor stock selection in the information technology, financials, and industrials sectors [1] Fund Performance - The Baird Chautauqua International Growth Fund underperformed the MSCI ACWI ex-U.S. Index - ND in Q3 2025 [1] - The Baird Chautauqua Global Growth Fund also trailed the MSCI ACWI Index – ND in the same quarter [1] Stock Highlights - Genmab A/S (NASDAQ:GMAB) is highlighted as a key stock, focusing on antibody-based products for cancer treatment [2] - Genmab A/S had a one-month return of -0.69% and a 52-week gain of 50.89%, closing at $31.49 per share with a market capitalization of $19.522 billion on December 30, 2025 [2] - Genmab A/S reported solid earnings and positive clinical trial results, receiving FDA Breakthrough Therapy Designation for its product candidate Rina-S [3] Hedge Fund Interest - At the end of Q3 2025, 20 hedge fund portfolios held Genmab A/S, an increase from 19 in the previous quarter [3] - Despite the potential of Genmab A/S, the analysis suggests that certain AI stocks may offer greater upside potential with less downside risk [3]
ABBV vs. AZN: Which Pharma Stock is the Better Investment Now?
ZACKS· 2025-12-23 16:56
Key Takeaways AbbVie is rebounding post-Humira, with Skyrizi and Rinvoq sales up 53% Y/Y and expected to top $25B in 2025.AZN's newer drugs are driving growth as it targets $80B in revenues by 2030.Both face pressures: ABBV from aesthetics softness, AZN from China policy impacts and biosimilar erosion.AbbVie (ABBV) and AstraZeneca (AZN) are both global healthcare companies with diversified drug portfolios. Both companies have strong leadership positions in immunology and oncology areas.While AbbVie also has ...
Here's How AbbVie's Oncology Drugs are Aiding Top-line Growth
ZACKS· 2025-12-11 13:51
Core Insights - AbbVie is significantly expanding its oncology presence, moving from a two-drug franchise to include solid tumors, with new drugs like Epkinly, Elahere, and Emrelis contributing to over 11% of total revenues in the first nine months of 2025, reflecting a 3% year-over-year growth [1][9] Expansion Strategies - The expansion is driven by both organic and inorganic strategies, with Emrelis being AbbVie's first internally developed solid tumor drug, while Epkinly and Elahere were acquired through collaborations [2] - Sales from newer drugs and rising Venclexta sales have offset the decline in Imbruvica sales due to competition from novel therapies [2] Pipeline Development - AbbVie has a diverse pipeline of new therapies for blood cancers and solid tumors, including antibody-drug conjugates (ADCs), which are seen as a disruptive innovation in cancer treatment [3] - A regulatory filing for the ADC therapy pivekimab sunirine is under FDA review for treating a rare blood cancer, which could add a third ADC to AbbVie's portfolio [4] - The company is also developing Temab-A for metastatic colorectal cancer and other cancers in various stages of clinical trials [4][5] Competitive Landscape - Major competitors in the oncology space include AstraZeneca, Merck, and Pfizer, with AstraZeneca's oncology sales accounting for 43% of total revenues and growing 16% year-over-year [6] - Merck's Keytruda accounted for about 48% of its total revenues, while Pfizer's oncology revenues grew 7%, making up over 27% of its total revenues [7] Financial Performance - AbbVie shares have outperformed the industry year to date, trading at a slight discount with a P/E ratio of 15.87 compared to the industry average of 16.31 [8][11] - EPS estimates for 2025 and 2026 have declined in the past 60 days, indicating potential challenges ahead [13]
Genmab(GMAB) - 2025 FY - Earnings Call Transcript
2025-12-04 15:47
Financial Data and Key Metrics Changes - Total revenue growth for the first nine months of the year was 21%, with recurring revenue growth of 26% [3][4] - The company is focused on maintaining financial discipline while achieving strong financial performance [4] Business Line Data and Key Metrics Changes - The late-stage programs, including Epkinly, RENA-S, and PETO, are expected to have meaningful registrational data and potential launches in 2027 [3][4] - Epkinly has been approved in third-line DLBCL and third-line follicular lymphoma, with ongoing efforts to expand into earlier lines of therapy [22][23] Market Data and Key Metrics Changes - The total addressable market for Epkinly in second-line follicular lymphoma is approximately 9,000 patients across major markets, contributing to a larger total addressable market of around 146,000 [26] - The company anticipates that PETO could exceed $1 billion in sales by 2029, indicating strong market potential [20] Company Strategy and Development Direction - The company has transitioned from a technology and out-licensing model to owning and marketing its own assets, focusing on growth through internal product development and strategic acquisitions [5][6] - The acquisition of Maris is aimed at enhancing capabilities in antibody development, particularly in oncology, and is seen as a natural evolution of the business [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the clinical data for PETO, highlighting its breakthrough therapy designation and strong efficacy in combination therapies [12][13] - The company is optimistic about the upcoming clinical readouts and potential launches, with a focus on maintaining a competitive edge in a crowded market [15][17] Other Important Information - The company is planning to start a phase 2 trial for non-small cell lung cancer, indicating a proactive approach to exploring new indications [46][48] - Aclasunamab is also progressing well in phase 3 trials, with potential to be a significant product in the non-small cell lung cancer market [49] Q&A Session Summary Question: What is the strategy for continuing growth of own products? - The company aims to own at least 50% of new products entering the clinic and has been building out development and commercialization capabilities since 2019 [6][7] Question: What is the rationale behind the Maris acquisition? - The acquisition is focused on enhancing capabilities in antibody development, particularly in oncology, and is expected to add substantial value post-deal close [9][10] Question: How does PETO compare to competition? - Management believes PETO has a strong product profile that could lead to a best-in-class designation, with plans to expand beyond current trials [15][16] Question: What are the expectations for Epkinly's market performance? - The company is confident in Epkinly's potential to reach $3 billion in peak year sales, contingent on successful expansion into earlier lines of therapy [23][27] Question: How does the company plan to manage operating expenses? - The company will invest in areas with clear return opportunities while maintaining efficiency in resource allocation [53][54]
Genmab(GMAB) - 2025 FY - Earnings Call Transcript
2025-12-04 15:47
Financial Data and Key Metrics Changes - Total revenue growth for the first nine months of the year was 21%, with recurring revenue growth of 26% [3][4] - The company is focused on maintaining financial discipline while achieving strong financial performance [4] Business Line Data and Key Metrics Changes - The late-stage programs, including Epkinly, RENA-S, and PETO, are expected to have meaningful registrational data and potential launches in 2027 [2][3] - Epkinly has been approved in third-line DLBCL and third-line follicular lymphoma, with ongoing phase three trials aimed at earlier lines of therapy [22][23] Market Data and Key Metrics Changes - The total addressable market for Epkinly is around 146,000 patients across major markets, with a specific focus on expanding into earlier lines of therapy [26][27] - The company anticipates that PETO could exceed $1 billion in sales by 2029, with significant readouts expected next year [20] Company Strategy and Development Direction - The company has transitioned from a technology and out-licensing model to owning and developing its own assets, focusing on antibody therapies in oncology [5][6] - The acquisition of Merus is part of a strategy to enhance capabilities and expand the oncology portfolio, particularly in head and neck cancer [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the clinical data for PETO, highlighting its breakthrough therapy designation and strong efficacy in combination therapies [12][13] - The company is optimistic about the upcoming clinical readouts and potential launches, which are expected to drive growth [20][39] Other Important Information - The company is committed to investing in its late-stage programs while managing leverage, aiming to be below three times gross leverage within 24 months of the Merus acquisition [51] - The focus remains on maximizing the potential of existing products while exploring new opportunities for growth [52] Q&A Session Summary Question: What is the strategy for continuing growth of own products? - The company aims to own at least 50% of new products entering the clinic and has been building out development and commercialization capabilities since 2019 [6][7] Question: What is the rationale behind the Merus acquisition? - The acquisition is intended to leverage existing capabilities in antibody therapies and enhance the oncology portfolio, particularly with PETO [9][10] Question: How does PETO compare to competitors? - Management believes PETO has a strong product profile and plans to expand its clinical trials to enhance its competitive position [15][16] Question: What is the expected timeline for data readouts and launches? - The company expects one or both ongoing phase three trials for PETO to read out next year, with a potential commercial launch in 2027 [20] Question: How is Epkinly positioned in the market? - Epkinly is currently approved for third-line therapies, with ongoing trials aimed at earlier lines, which are crucial for achieving its peak sales target [22][23]
Genmab(GMAB) - 2025 FY - Earnings Call Transcript
2025-12-04 15:45
Financial Data and Key Metrics Changes - Total revenue growth for the first nine months of the year was 21%, with recurring revenue growth of 26% [3][4] - The company is focused on maintaining financial discipline while achieving strong financial performance [4] Business Line Data and Key Metrics Changes - The late-stage programs, including Epkinly, RENA-S, and PETO, are expected to have meaningful registrational data and potential launches in 2027 [3][4] - Epkinly has been approved in third-line DLBCL and third-line follicular lymphoma, with ongoing efforts to expand into earlier lines of therapy [24][28] Market Data and Key Metrics Changes - The total addressable market for Epkinly in second-line follicular lymphoma is around 9,000 patients across major markets, contributing to a larger total addressable market of approximately 146,000 [27][28] - The company anticipates that PETO could exceed $1 billion in sales by 2029, indicating strong market potential [21] Company Strategy and Development Direction - The company has transitioned from a technology and out-licensing model to owning and developing its own assets, focusing on building capabilities in the U.S. and Japan [6][7] - The acquisition of Merus is part of a strategy to enhance capabilities in antibody development, particularly in oncology [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the clinical data for PETO, highlighting its breakthrough therapy designation and strong efficacy in combination therapies [12][13] - The company is optimistic about the upcoming clinical readouts and potential launches, particularly in 2026 and 2027 [21][42] Other Important Information - The company is committed to investing in its late-stage programs while managing leverage, aiming to be below three times gross leverage within 24 months of the Merus acquisition [52] - The focus remains on maximizing the potential of existing products while exploring new opportunities for growth [53] Q&A Session Summary Question: What is the strategy for continuing growth of own products? - The company aims to own at least 50% of new products entering the clinic and has been building out development and commercialization capabilities since 2019 [6][7] Question: What is the rationale behind the Merus acquisition? - The acquisition is intended to leverage existing expertise in antibodies and oncology, enhancing the company's growth trajectory [9][10] Question: How does PETO compare to competitors? - PETO is positioned as a potential best-in-class product with strong efficacy data, and the company plans to expand its clinical trials [15][16] Question: What are the expectations for Epkinly's market performance? - The company expects Epkinly to achieve peak year sales of $3 billion, contingent on successful expansion into earlier lines of therapy [24][28] Question: How will the company manage operating expenses with upcoming launches? - The company plans to invest strategically in areas with clear return opportunities while maintaining operational efficiency [55]
Genmab (NasdaqGS:GMAB) 2025 Conference Transcript
2025-11-19 13:02
Summary of Genmab's Conference Call Company Overview - **Company**: Genmab - **Event**: Jefferies London Healthcare Conference - **Key Speakers**: CEO Jan van de Winkel, CFO Anthony Pagano Key Focus Areas Late-Stage Programs - Genmab is focusing on late-stage programs including: - **Epkinly** - **Rinatabart sesutecan** - **Acasunlimab** - **Patu Centamab** (acquisition of Merus) [2][3][4] Patu Centamab - **Description**: A bispecific antibody targeting EGFR, showing significant tumor shrinkage in clinical trials. - **Clinical Data**: - In frontline head and neck cancer, a **63% overall response rate** when combined with Pembrolizumab, tripling the benchmark response [9]. - In second-line settings, a **36% overall response rate** with impressive median progression-free survival of **11.4 months** [9]. - **Safety Profile**: New dosing schedules have improved infusion-related reactions, and a subcutaneous version is in development to further mitigate these issues [11]. - **Potential**: Beyond head and neck cancer, Patu Centamab is expected to have applications in other EGFR-positive tumors [6][12]. Epkinly - **Launch Performance**: Launched in May 2023, with potential to become a **$3 billion-plus global brand**. - **Recent Developments**: Positive data in second-line follicular lymphoma, with a significant hazard ratio of **0.21**, indicating a **79% risk reduction** for disease progression [21]. - **Commercial Strategy**: Focus on subcutaneous delivery and maintaining a balance of safety and efficacy [20]. Rinatabart sesutecan - **Characteristics**: Combines a good antibody with a hydrophilic linker, allowing for multiple toxin attachments without compromising pharmacodynamics [23]. - **Clinical Data**: Expected to have a clean safety profile with no ocular toxicity or interstitial lung disease observed [24]. - **Market Potential**: Peak year sales guidance upgraded to **$2 billion**, with a launch expected in **2027** [28]. Acasunlimab - **Clinical Development**: Ongoing studies in second-line plus lung cancer, with follow-up data expected to bolster confidence in its efficacy [30]. - **Sales Guidance**: Projected peak sales of around **$1 billion**, reflecting a conservative approach due to competition in the lung cancer market [31]. Financial Considerations - **Investment Strategy**: 2026 is expected to be an investment year, focusing on late-stage pipeline and commercialization capabilities [14][15]. - **EBITDA Growth**: Anticipated meaningful growth in EBITDA by **2027**, with projections of over **$1 billion** in sales for Patu Centamab by **2029** [16][17]. Other Considerations - **Pipeline Focus**: Genmab remains primarily focused on oncology, with over **90%** of activities in this area, while maintaining some preclinical work in immunology and inflammation [34][35]. - **Future Developments**: Plans to advance two bispecifics and one ADC from the organic pipeline by the end of the year [36]. Conclusion - Genmab is strategically positioned with a robust late-stage pipeline and a clear focus on maximizing the potential of its key assets, particularly Patu Centamab, Epkinly, and Rinatabart sesutecan, while managing investments and operational efficiencies to drive future growth.
Genmab(GMAB) - 2025 Q3 - Earnings Call Transcript
2025-11-06 18:00
Financial Data and Key Metrics Changes - Total revenue grew by 21% year-over-year, driven by increased recurring revenue, with recurring revenue up 26% [5][22][24] - Operating profit increased by 52%, reflecting strong financial performance despite strategic investments [5][25] - The company ended the first half of 2025 with approximately $3.4 billion in cash, providing flexibility for growth and expansion [5] Business Line Data and Key Metrics Changes - Sales from Epkinly and TIVDAK increased by 54% year-over-year, contributing 25% to total revenue growth [15][22] - Epkinly sales reached $333 million through Q3, representing a 64% year-over-year increase, establishing it as a leader in the third-line setting for diffuse large B-cell lymphoma and follicular lymphoma [17][19] - TIVDAK sales totaled $120 million year-to-date, with strong performance in both new and established markets [20] Market Data and Key Metrics Changes - Epkinly has received regulatory approvals in over 65 countries, with more than 50 countries now having dual indications [19] - The company is preparing for the launch of Epkinly in earlier lines of therapy, particularly in second-line follicular lymphoma, with an estimated 9,000 patients in this segment [42] Company Strategy and Development Direction - The proposed acquisition of Merus is seen as a transformative opportunity, advancing the company's evolution into a global biotech leader and expanding its revenue base [6][30] - The company aims to maximize the potential of its commercialized medicines while accelerating the development of its late-stage pipeline [5][6] - The focus remains on high-impact programs, with ongoing phase 3 trials for rinatabart sesutecan and Petosemtamab expected to drive future growth [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of rinatabart sesutecan and Petosemtamab as key growth drivers, with expectations for significant market opportunities [7][36] - The company anticipates continued strong performance and is on track to achieve double-digit revenue and profit growth for 2025 [26][28] Other Important Information - The company has initiated additional phase 3 clinical trials for rinatabart sesutecan, reinforcing its commitment to advancing its innovative pipeline [11][29] - The annual R&D updates and data review will be held virtually on December 11, 2025 [31] Q&A Session Summary Question: Competitive landscape of Petosemtamab and Rinatabart sesutecan - Management remains confident in the positioning of both drugs as best-in-class assets, with ongoing phase 3 trials supporting their development [34][36] Question: Commercial dynamics of Epkinly - The dual indication of Epkinly is beneficial for operationalization, and the company expects significant growth opportunities in earlier lines of therapy [40][41] Question: Termination of clinical development for 1042 - The decision was based on data not meeting internal development standards, leading to a halt in the program [51][52] Question: Confidence in Epkinly's upcoming PDUFA - Management expressed high confidence in the approval process, with no indications suggesting otherwise [55][57] Question: OpEx and profitability outlook for 2026 - The company maintains a disciplined investment approach, with expectations for significant profitability and operational efficiency [62][66]
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]