Group 1 - Genmab A/S is recognized as a global leader in antibody-based therapies, with significant commercial successes and advancements in late-stage clinical trials in 2025 [1][4] - The company markets therapies such as Tivdak for cervical cancer and Epkinly for lymphoma, while also developing a strong pipeline focused on high-need oncology indications [1][4] - A notable achievement for Genmab this year is the FDA's Breakthrough Therapy Designation for rinatabart sesutecan (Rina-S), which is aimed at treating recurrent or progressive endometrial cancer [2][4] Group 2 - Genmab's bispecific antibody epcoritamab shows promising results as an outpatient therapy for diffuse large B-cell lymphoma (DLBCL), with 92% of patients able to receive their first full dose in an outpatient setting [3] - The company is expanding the global reach of its marketed therapies, Tivdak and Epkinly, while utilizing its KYSO antibody platform to enhance its pipeline [4]

Core Insights - Genmab is currently represented by Jan and Anthony, who will provide an overview of the company's revenue sources and future expectations [2] Group 1 - Genmab's history and current revenue sources will be discussed, along with anticipated changes in these sources over the coming years [2]

PresentationJudah FrommerEquity Analyst Good morning, everyone. Welcome to this session of the Morgan Stanley Global Healthcare Conference Day 2. Let me just read a quick disclosure before we get started with Genmab here. For important disclosures, please see the Morgan Stanley Research Disclosures website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. So with that, I'm very excited to welcome the Genmab team. We have Ja ...

Summary of Genmab FY Conference Call - September 09, 2025 Company Overview - **Company**: Genmab (NasdaqGS: GMAB) - **Focus**: Differentiated antibody therapeutics with a history of successful product development, including Tivdak and EPKINLY, and ongoing late-stage clinical trials for new products [2][3][4] Key Points Revenue Sources and Growth Strategy - Genmab has a strong pipeline with eight approved antibody therapeutics based on its science, with two commercialized products: Tivdak and EPKINLY [2] - The company aims to expand its product offerings through internal development and external opportunities, ensuring sustainable growth for decades [2] EPKINLY Development and Market Potential - EPKINLY is currently in phase III trials for first-line diffuse large B-cell lymphoma (DLBCL), with recruitment completed ahead of schedule and results expected by the end of next year [3][4] - The second-line follicular lymphoma trial showed a hazard ratio of 0.21, indicating a 79% lower risk of disease progression, which is unprecedented [5] - EPKINLY is positioned to become a backbone therapy for B-cell cancers due to its efficacy, safety profile, and ease of administration [8][24] RINASCE and Competitive Positioning - RINASCE utilizes unique linker technology and a drug-to-antibody ratio of eight, allowing for effective treatment of platinum-resistant ovarian and endometrial cancers [10][11] - The company plans to initiate phase III trials for RINASCE in both platinum-resistant and platinum-sensitive ovarian cancer, targeting a market of approximately 25,000 patients [16] - RINASCE is expected to broaden its application to non-small cell lung cancer and other indications, leveraging its differentiated characteristics [11][18] Commercialization Strategy - Genmab is focused on expanding EPKINLY's presence in community healthcare settings, which is crucial for early treatment lines [30][31] - The company reported $211 million in global sales for EPKINLY in H1 2025, indicating strong market performance [34] - Genmab's commercialization strategy includes leveraging its existing capabilities to support the launch of RINASCE and other products [36] Capital Allocation and R&D Focus - The capital allocation strategy prioritizes investment in late-stage programs (EPKINLY, RINASCE, Akasunimab) while maintaining a focus on early-stage research and innovation [38][39] - Genmab is open to external opportunities but emphasizes careful evaluation and integration of potential acquisitions [40] AI and Innovation - Genmab is actively leveraging AI across its operations, including drug discovery and clinical trial optimization, aiming to accelerate the development process [50][51] - The company has established a dedicated team for data science and AI initiatives to enhance its capabilities [52] Regulatory Landscape - Genmab is closely monitoring regulatory changes and geopolitical dynamics, with a proactive approach to adapt to potential impacts on its business [54][55] Additional Insights - The company is expanding its footprint in the Chinese biotech landscape through its acquisition of Profound Bio, which enhances its innovation capabilities [47][48] - Genmab is also exploring the potential of its technologies in other therapeutic areas, including autoimmune diseases and hemophilia [26][29] This summary encapsulates the key insights from the Genmab FY Conference Call, highlighting the company's strategic focus on oncology, product development, and market expansion.

Core Insights - Genmab A/S announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the investigational epcoritamab for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in an outpatient setting [2][4] - The trial demonstrated the feasibility of outpatient treatment, with 92% of patients receiving the first full dose in this setting, and showed consistent safety and efficacy profiles compared to previous studies [3][4] Study Results - A total of 88 patients received the first full dose (48 mg) of epcoritamab, with 81 patients (92%) treated as outpatients [3] - The overall response rate (ORR) was 64.3% and the complete response (CR) rate was 47.6% in patients who had received one prior line of systemic therapy [4] - In patients treated after two or more lines of therapy, the ORR was 60.0% and the CR rate was 38.0% [4] Safety Profile - Cytokine release syndrome (CRS) occurred in 40.2% of patients during the trial, primarily low grade (Grade 1-2), with a median resolution time of two days [3] - Immune cell-associated neurotoxicity syndrome (ICANS) was observed in 7.6% of patients, also primarily low grade, resolving within a median of three days [3] Industry Context - DLBCL is the most common type of non-Hodgkin lymphoma, accounting for approximately 25-30% of all NHL cases, with around 25,000 new cases diagnosed annually in the U.S. [7][8] - The EPCORE NHL-6 trial results are significant as they suggest a shift towards outpatient treatment options for DLBCL patients, potentially increasing access to therapies [4]

Company Overview - Genmab A/S is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics [2][3] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific [3] Upcoming Events - Genmab's CEO Jan Van de Winkel and CFO Anthony Pagano will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:45 AM EDT [1] Strategic Vision - By 2030, Genmab aims to transform the lives of patients with cancer and other serious diseases through its proprietary pipeline, which includes bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators [2]

Core Perspective - Genmab A/S announced that the U.S. FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S) for treating adult patients with recurrent or progressive endometrial cancer who have experienced disease progression after prior treatments [2][7] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform the lives of patients with cancer and other serious diseases by 2030 [10][11] Product Development - Rina-S is an investigational antibody-drug conjugate targeting folate receptor alpha (FRα) and is currently undergoing late-stage development, including ongoing Phase 1/2 and Phase 3 trials for various cancers [4][8] - The Breakthrough Therapy Designation is supported by results from the Phase 1/2 RAINFOL™-01 trial, which showed encouraging responses in heavily pretreated endometrial cancer patients [3][7] Clinical Trial Insights - The RAINFOL™-01 trial is an open-label, multicenter study designed to evaluate the safety and efficacy of Rina-S in solid tumors expressing FRα, with multiple cohorts focusing on different cancer types [5][8] - The trial's B2 cohort included 64 patients with advanced or recurrent endometrial cancer who had progressed after anti-PD-(L)1 and platinum-based chemotherapy [3][6] Market Context - Endometrial cancer is the second most prevalent gynecologic cancer globally, with increasing incidence and limited treatment options for advanced cases, highlighting the need for innovative therapies like Rina-S [6][8]

Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]

Core Viewpoint - Genmab A/S Sponsored ADR (GMAB) has seen a 3.8% increase in share price over the past four weeks, closing at $22.69, with a potential upside of 33.8% based on Wall Street analysts' mean price target of $30.36 [1] Price Targets - The average price target consists of seven estimates ranging from a low of $20.00 to a high of $46.00, with a standard deviation of $8.82, indicating variability among analysts [2] - The lowest estimate suggests an 11.9% decline from the current price, while the highest estimate indicates a 102.7% upside [2] Analyst Sentiment - Analysts show a consensus that GMAB will report better earnings than previously estimated, which historically correlates with stock price increases [4][11] - The Zacks Consensus Estimate for the current year has increased by 0.1% over the past month, with one estimate rising and no negative revisions [12] Zacks Rank - GMAB holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for upside [13] Conclusion on Price Targets - While the consensus price target may not be a reliable measure of the extent of GMAB's potential gains, it does provide a useful indication of the expected direction of price movement [14]

Financial Data and Key Metrics Changes - Total revenue grew by 19% in the first half of 2025, driven by increased recurring revenue [5][30] - Operating profit increased by 56%, reflecting strong financial performance despite strategic investments [6][35] - Cash reserves at the end of the first half were approximately $3 billion, providing flexibility for growth and expansion [6][30] - Recurring revenues represented 97% of total revenue, up from 90% in the same period last year [33] Business Line Data and Key Metrics Changes - Sales for Epkinley and TIVDAC increased by 60% year over year, contributing to 31% of total revenue growth [22][30] - Epkinley achieved $211 million in global sales, a 74% increase year over year [23] - TIVDAC sales totaled $78 million, reflecting a 30% increase compared to the previous year [27] Market Data and Key Metrics Changes - Epkinley received regulatory approvals in over 60 countries, with nearly 50 countries approving it for both DLBCL and FL indications [25] - The launch of Epkinley in Japan for third-line follicular lymphoma began in May, showing encouraging uptake [24][27] Company Strategy and Development Direction - The company aims to accelerate the development of its late-stage pipeline and maximize the potential of its commercialized medicines [5][39] - Plans to broaden the reach of RINA S with three Phase III trials expected to be underway by the end of the year [11][39] - The company is focused on expanding its pipeline both organically and inorganically to ensure sustainable long-term growth [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting strong financial foundations and disciplined capital allocation strategies [38][39] - The company anticipates continued growth for Epkinley and TIVDAC, with further data expected to support their market positions [39] Other Important Information - The FDA accepted the supplemental BLA for epiritamab with a target action date of November 30, 2025 [9][56] - The company is actively engaging with the FDA regarding regulatory submissions and believes there is no significant risk of pushback [56] Q&A Session Summary Question: Positioning of EPCO versus other CD20 bispecifics - Management feels confident about their broad and aggressive development plan, with a head start in second-line follicular lymphoma [44][45] - The company has received positive feedback from physicians and is encouraged by its leading sales position globally [48] Question: Confidence in filing RAINFALL-one for accelerated approval - Management is optimistic about filing for accelerated approval based on strong data and ongoing engagement with the FDA [55][56] Question: Initial launch strategy for Epkinley - The focus will be on earlier lines of therapy, particularly in the community setting, where uptake has been accelerating [63] Question: Development plans for RINA S outside ovarian cancer - The company is exploring RINA S in non-small cell lung cancer, with a Phase II study planned to assess both monotherapy and combination therapy [91][92] Question: Role of ADC combinations in lymphoma - Management sees potential for ADC combinations in diffuse large B cell lymphoma and believes bispecifics will become a backbone for novel combinations [87][88]