Group 1 - Israel's stock market has outperformed the U.S. market since October 7, 2023, with significant gains in U.S.-traded companies such as Teva Pharmaceutical, Elbit Systems, and Tower Semiconductor [4] - The Dow Jones Industrial Average and other stock indexes are experiencing mixed trading, with companies like Caterpillar, Genmab, KLA, and Penumbra being highlighted as key stocks to watch [5] - Taiwan Semiconductor is leading a rebound among AI-related stocks, with Genmab and JPMorgan also noted as stocks to monitor [6] Group 2 - IBM has made an $11 billion acquisition of Confluent, which is expected to enhance its AI initiatives [7] - The market trend remains bullish, with a focus on tech stocks such as Penumbra, Vertiv, and JPMorgan [8] - Genmab is leveraging an $8 billion deal to drive its next growth phase, indicating strong relative strength in the stock market [10]

Core Insights - Genmab A/S announced new data from the Phase 1b/2 EPCORE CLL-1 trial evaluating epcoritamab-bysp for treating Richter transformation (RT) in chronic lymphocytic leukemia (CLL) patients, highlighting its potential as a therapeutic option [2][11] Group 1: Epcoritamab Monotherapy (Arm 2A) - In Arm 2A, 42 patients with RT received epcoritamab monotherapy, achieving an overall response rate (ORR) of 57% in first-line settings and 38% in second- or later-line settings [3][4] - The median overall survival (OS) was 27.5 months for first-line patients, while second- or later-line patients had a median OS of 9.8 months [3] - Cytokine release syndrome (CRS) occurred in 86% of patients, with 79% experiencing Grade 1/2 events, and most CRS events resolved within a median of three days [4] Group 2: Epcoritamab and Lenalidomide Combination (Arm 2B) - In Arm 2B, 11 previously-treated RT patients received epcoritamab combined with lenalidomide, resulting in an ORR of 82% and a complete response (CR) rate of 73% [5][6] - The median progression-free survival (PFS) was 5.7 months, with median OS not reached at nine months [5] - CRS events were primarily low grade, resolving in a median of four days, with one patient discontinuing due to CRS [6] Group 3: Epcoritamab and R-CHOP Combination (Arm 2C) - In Arm 2C, 30 previously untreated RT patients received epcoritamab combined with R-CHOP, achieving an ORR of 77% and a CR rate of 63% [8][9] - The median OS was 16.4 months, and the median PFS was 16.0 months [9] - CRS events were primarily low grade, with a median resolution time of 2.0 days, and no patients discontinued due to CRS [10] Group 4: Safety Profile - Across all arms, common treatment-emergent adverse events (TEAEs) included infection (74%), anemia (50%), and thrombocytopenia (48%) in Arm 2A [12] - In Arm 2B, 100% of patients experienced CRS, with serious TEAEs occurring in 10 out of 11 patients [12] - Arm 2C reported 90% of patients experiencing Grade ≥3 TEAEs, with three treatment-related Grade 5 events [12] Group 5: Background on Richter Transformation - Richter transformation (RT) is a rare and aggressive evolution of CLL, often leading to poor prognosis with complete remission rates around 20% and median survival less than one year following standard treatments [13] Group 6: Trial Overview - The EPCORE CLL-1 trial is a global, Phase 1b/2 study assessing the safety and preliminary efficacy of epcoritamab in patients with relapsed/refractory CLL, SLL, and RT [14]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE® FL-1 study, demonstrating that the combination of EPKINLY® (epcoritamab) with rituximab and lenalidomide significantly reduces the risk of disease progression or death by 79% compared to standard care [2][3] - The overall response rate (ORR) for patients treated with EPKINLY + R2 was 95%, compared to 79% for those receiving R2 alone, indicating a substantial improvement in treatment efficacy [2][3] - The U.S. FDA has approved the EPKINLY + R2 combination for patients with relapsed or refractory follicular lymphoma after one or more lines of systemic therapy, marking a significant advancement in treatment options [4][5] Study Results - The EPCORE FL-1 study included patients with relapsed or refractory follicular lymphoma, showing that 83% of patients achieved a complete response (CR) with EPKINLY + R2, compared to 50% with R2 alone [3][5] - The duration of response (DOR) at 12 months was 89% for EPKINLY + R2 versus 49% for R2, highlighting the long-term benefits of the new treatment [3][5] - The safety profile of EPKINLY + R2 was consistent with known safety profiles, with 90.1% of patients experiencing Grade 3 or 4 treatment-emergent adverse events (TEAEs) [3][4] Industry Context - Follicular lymphoma is a common form of non-Hodgkin lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new diagnoses in the U.S. annually [7] - Current standard treatments are often ineffective over time, leading to relapses and shorter remission periods, which underscores the need for innovative therapies like EPKINLY [7] - Epcoritamab, developed using Genmab's DuoBody technology, is designed to target both T cells and B cells, enhancing the immune response against cancer cells [8][9] Future Developments - Genmab and AbbVie are continuing to explore the use of epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials assessing its efficacy as a monotherapy and in combination with other treatments [9] - The companies aim to expand regulatory approvals for epcoritamab in additional indications, including relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [8][9] - Genmab's vision is to transform cancer treatment through innovative antibody medicines, with a focus on improving patient outcomes [10]

Core Insights - Genmab A/S announced updated results from two clinical trials evaluating epcoritamab-bysp for treating diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), showing high overall response rates (ORR) and promising survival outcomes [2][8][11]. Trial Results Summary - In the EPCORE NHL-2 trial, Arm 8 demonstrated an ORR of 93% and a complete response (CR) rate of 86% in elderly patients with newly diagnosed DLBCL, with 79% of responders maintaining their response at two years [4][6]. - Arm 1 of the same trial showed an ORR of 98% and an 85% CR rate in patients with newly diagnosed DLBCL, with 74% of CRs ongoing after a median follow-up of 44.2 months [7][9]. - The EPCORE DLBCL-3 trial reported a 73% ORR and 62% CR rate in elderly patients unable to receive standard chemotherapy, with 54% progression-free and 65% alive at one year [3][14]. Safety Profile - Treatment-emergent adverse events (TEAEs) were consistent with previous studies, with Grade ≥3 infections occurring in 32% of patients, primarily in the first six cycles [5][10]. - Serious TEAEs included Grade 5 events, but no new serious infections were reported post-treatment [10][15]. Epcoritamab Overview - Epcoritamab is a bispecific antibody designed to engage T-cells and target B-cells, showing potential as a core therapy for various B-cell malignancies [23][24]. - The drug has received regulatory approval in certain lymphoma indications and is co-developed by Genmab and AbbVie [24][25]. Industry Context - DLBCL is the most common type of non-Hodgkin lymphoma, accounting for 25-30% of cases, with approximately 25,000 new cases diagnosed annually in the U.S. [17]. - Follicular lymphoma, accounting for 20-30% of NHL cases, is considered incurable with current therapies, highlighting the need for effective treatment options [18].

Core Viewpoint - Baylin Technologies has announced the acquisition of Kaelus, marking a significant milestone in its growth strategy and operational transformation [1][2]. Group 1: Company Overview - Baylin Technologies has transitioned through different phases, with Baylin 1.0 characterized by four business units and financial struggles, including a negative adjusted EBITDA of $15 million and $40 million in debt for the first half of 2021 [2]. - The company has successfully divested its non-core mobile business, leading to sustained profitable growth and a more focused operational strategy [2]. Group 2: Financial Performance - As part of its transformation to Baylin 2.0, the company has reduced its debt by approximately 50% and improved its gross margins to around 43% [2].

Core Viewpoint - Genmab has made significant progress in its late-stage programs, particularly with three key assets that have received FDA breakthrough therapy designations, indicating strong potential for future growth and product launches [2]. Group 1: Company Progress - Genmab's late-stage programs include EPKINLEY, Rina-S, and peto, all of which have received at least one FDA breakthrough therapy designation [2]. - The company has observed significant clinical data developments in 2025 that have bolstered confidence in these programs [2]. - Looking ahead to 2026, Genmab anticipates meaningful registrational data that could lead to important product launches in 2027 [2].

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]

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]

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]

Core Viewpoint - Genmab A/S has successfully closed an offering of $1.5 billion in senior secured notes and $1.0 billion in senior unsecured notes to fund the acquisition of Merus N.V. and related expenses [1][2]. Group 1: Offering Details - The offering includes $1.5 billion of 6.250% senior secured notes due 2032 and $1.0 billion of 7.250% senior unsecured notes due 2033 [1]. - The net proceeds from the offering will be used alongside new credit facilities totaling $3.5 billion to finance the acquisition of Merus N.V. and associated costs [2]. Group 2: Security and Guarantees - Prior to the acquisition closing, the notes will be secured by segregated accounts holding the gross proceeds [3]. - After the acquisition, the secured notes will be backed by a first priority security interest in certain assets of Genmab and its subsidiaries [3]. Group 3: Covenants and Restrictions - The indentures governing the notes include customary covenants that restrict Genmab and its subsidiaries from incurring additional debt, paying dividends, and engaging in significant asset disposals or mergers [4]. Group 4: Regulatory Compliance - The notes have not been registered under the Securities Act and are offered only to qualified institutional buyers or non-U.S. persons outside the United States [5].