Summary of Genmab's ASH 2025 Update Company Overview - **Company**: Genmab - **Event**: ASH 2025 update and R&D review Key Highlights 1. **Strategic Acquisitions and Growth** - Genmab proposed the acquisition of Mirus and added Pathosentomab to its portfolio, positioning for sustained growth and long-term value creation [3][4] - The integration of Mirus is a key priority for 2026, with expectations for the transaction to close in Q1 2026 [4] 2. **Pipeline Developments** - Significant progress in the development of RINA-S, with three phase three trials and two phase two potentially registrational trials ongoing [5] - Epcoritamab has shown promising results in various lymphoma settings, with 31 abstracts accepted at ASH, including seven oral presentations [9][10] 3. **Epcoritamab Data** - In the EPCORE FL-1 study, the addition of epcoritamab to R squared resulted in a 79% risk reduction in progression or death, with a hazard ratio of 0.21 [17] - Overall response rate was 95% for the combination versus 79% for R squared alone, with a complete response rate of 83% compared to 50% [18] - The study demonstrated a significant improvement in duration of response, with a hazard ratio of 0.19 [19] 4. **Regulatory Approvals** - Epcoritamab received FDA approval for the treatment of follicular lymphoma after at least one line of therapy [25] - Ongoing global regulatory submissions are expected to be positively received [25] 5. **Future Expectations** - 2026 is anticipated to be a year of important catalysts, including multiple potential registrational data sets for EPCORE, RINA-S, and beta centromere [34] - Genmab aims to advance its evolution into a global biotech leader with a diversified, fully integrated model [35] Industry Context - **Oncology Market** - The oncology community is seeing a shift towards bispecific antibodies like epcoritamab, which offer off-the-shelf solutions and are easier to administer compared to CAR-T therapies [46] - Epcoritamab's subcutaneous administration and manageable safety profile are key differentiators for adoption in community settings [37] Additional Insights - **Safety and Tolerability** - Epcoritamab's safety profile showed manageable adverse events, with no severe cytokine release syndrome reported [21][22] - Proactive management of infections is emphasized, particularly in outpatient settings [23][40] - **Comparative Efficacy** - The discussion around sequencing CAR-T and bispecific therapies indicates that bispecifics may serve as effective bridging therapies before CAR-T cell collection [44] - The potential for improved overall survival with epcoritamab in comparison to existing therapies is a focal point for future studies [51] This summary encapsulates the key points from Genmab's ASH 2025 update, highlighting the company's strategic direction, pipeline advancements, and the evolving landscape of oncology treatments.

Core Insights - Genmab has made significant advancements in its late-stage portfolio, with Epcoritamab nearing availability for earlier treatment lines in follicular lymphoma and Rina-S receiving Breakthrough Therapy Designation for advanced endometrial cancer [2][6] - The proposed acquisition of Merus is expected to enhance Genmab's late-stage pipeline by adding petosemtamab, which has two Breakthrough Therapy Designations, and is anticipated to drive sustained growth into the next decade [2][8] Financial Performance - Genmab's revenue for the first nine months of 2025 reached $2,662 million, a 21% increase from $2,198 million in the same period of 2024, primarily driven by higher royalties from DARZALEX and Kesimpta, as well as increased net product sales of EPKINLY [6][7] - Royalty revenue increased to $2,219 million in the first nine months of 2025, up from $1,802 million in the same period of 2024, marking a 23% rise [7] - Operating profit for the first nine months of 2025 was $1,007 million, compared to $662 million in the same period of 2024 [7] Strategic Outlook - Genmab is maintaining its financial guidance for 2025 as published on August 7, 2025 [4] - The company has transitioned its functional and presentation currency from DKK to USD effective January 1, 2025, with retrospective adjustments made to prior periods [5] Acquisition Details - Genmab intends to acquire Merus for $97.00 per share in an all-cash transaction valued at approximately $8.0 billion, funded through cash on hand and $5.5 billion of non-convertible debt financing [8] - The acquisition is expected to close by early Q1 2026, subject to customary closing conditions [8]

Summary of Genmab's Conference Call on Proposed Acquisition of Merus N.V. Company and Industry - **Company**: Genmab (NasdaqGS: GMAB) - **Industry**: Biotechnology, specifically focused on antibody-based therapies Core Points and Arguments 1. **Proposed Acquisition**: Genmab announced a transformative acquisition of Merus N.V. for $97 per share, totaling approximately $8 billion, expected to close in early Q1 2026, pending regulatory approvals [3][14][21] 2. **Strategic Importance**: The acquisition aligns with Genmab's vision to transition from a royalty-dependent model to a fully integrated biotech company that owns, develops, and commercializes its own medicines [4][5][19] 3. **Pipeline Enhancement**: The addition of petosemtamab (PETO) to Genmab's late-stage pipeline is expected to strengthen its position, with PETO having received two breakthrough therapy designations from the FDA [4][6][12] 4. **Market Potential**: PETO is anticipated to have multibillion-dollar peak sales potential, with an initial launch expected in 2027 [5][19] 5. **Clinical Development**: Genmab is confident in PETO's efficacy, with clinical trials showing a 36% response rate in second-line settings and a 63% response rate in first-line settings when combined with pembrolizumab [11][12] 6. **Financial Outlook**: The acquisition is projected to be accretive to EBITDA by 2029, with expectations of significant profitability in 2026 and meaningful growth in 2027 [16][19] 7. **Investment Strategy**: Genmab plans to invest in R&D and commercialization for PETO while maintaining profitability, with a commitment to rapid deleveraging post-acquisition [15][17][19] 8. **Long-term Vision**: The acquisition is seen as a key step towards achieving Genmab's 2030 vision of improving patient lives through innovative therapies [4][21] Additional Important Content 1. **Clinical Trials**: Two phase 3 trials for PETO are ongoing, with expected top-line data readouts in 2026 [10][60] 2. **Safety Profile**: PETO has shown a manageable safety profile, with infusion-related reactions primarily occurring during the first cycle [13][12] 3. **Competitive Landscape**: The potential for PETO to transform treatment in head and neck cancer is emphasized, particularly in settings where current therapies have limited efficacy [10][62] 4. **Platform Acquisition**: The acquisition of Merus N.V. is not just about PETO but also about integrating Merus's bispecific antibody technology platform, which complements Genmab's existing capabilities [90][92] 5. **Future Development**: Discussions on potential expansion into colorectal cancer are premature until more data is available, but the mechanism of action for PETO shows promise across different cancer types [52][84] This summary encapsulates the key points from Genmab's conference call regarding the acquisition of Merus N.V. and the strategic implications for the company's future in the biotechnology sector.

Core Insights - Genmab has made significant progress in the first eight months of 2025, particularly with its late-stage programs EPKINLY and Rina-S, showcasing promising data and product profiles [3][4]. Group 1: Product Development - The company is excited about the emerging target product profiles for its late-stage programs, especially Rina-S, which has shown strong proof-of-concept data in second-line endometrial cancer and platinum-resistant ovarian cancer [3]. - Rina-S is demonstrating a compelling product profile across various dimensions, including activity at different expression levels, response rates, duration of response, and safety [4]. - There is a clear line of sight to potential registrational data for Rina-S moving into 2026, indicating strong future prospects for the product [4].

Core Insights - Genmab has made significant progress in its strategic priorities, focusing on expanding access to innovative therapies and maximizing the potential of its commercialized medicines [2] - The company has updated its revenue and operating profit guidance for 2025, driven by increased royalty revenues from DARZALEX [4] Financial Performance - Revenue for the first half of 2025 reached $1,640 million, a 19% increase from $1,382 million in the same period of 2024, primarily due to higher royalties from DARZALEX and Kesimpta, as well as increased EPKINLY net product sales [6][7] - Royalty revenue was $1,378 million in the first half of 2025, up 24% from $1,111 million in the first half of 2024, attributed to higher net sales of DARZALEX and Kesimpta [7] - Operating profit for the first half of 2025 was $548 million, compared to $352 million in the first half of 2024 [7] 2025 Full Year Outlook - Revised revenue guidance for 2025 is set between $3,500 million and $3,700 million, with a midpoint of $3,600 million, an increase from the previous guidance of $3,340 million to $3,660 million [5] - Royalties are expected to be between $2,945 million and $3,090 million, with a midpoint of $3,017 million, up from the previous guidance of $2,785 million to $3,015 million [5] - Net product sales/collaboration revenue is projected to be between $425 million and $465 million, with a midpoint of $445 million [5] Pipeline Developments - Epcoritamab is advancing to earlier lines of therapy with a supplemental Biologics License Application (sBLA) submitted to the FDA for use in patients with relapsed or refractory follicular lymphoma [6] - Rina-S continues to show promising antitumor activity in endometrial cancer, with data presented at the 2025 ASCO Annual Meeting [6] Other Matters - Genmab has changed its functional currency and presentation currency from DKK to USD effective January 1, 2025, with retrospective adjustments made to prior periods [9]

Core Insights - Genmab demonstrated significant progress in advancing its late-stage programs, with EPKINLY and Tivdak receiving approvals in additional territories, and Rina-S showing potential as a treatment for advanced ovarian cancer [2][7] Financial Performance - Genmab reported a revenue increase of 19% in Q1 2025, reaching $715 million compared to $603 million in Q1 2024, driven by higher royalties from DARZALEX and Kesimpta, as well as EPKINLY net product sales [7][8] - Royalty revenue rose to $589 million in Q1 2025, up 30% from $452 million in Q1 2024, attributed to increased net sales of DARZALEX and Kesimpta [8] - Net sales of DARZALEX reached $3,237 million in Q1 2025, a 20% increase from $2,692 million in Q1 2024 [8] - Total costs and operating expenses were $527 million in Q1 2025, an 8% increase from $487 million in Q1 2024, primarily due to product pipeline expansion and profit-sharing with AbbVie [8] - Operating profit for Q1 2025 was $188 million, compared to $116 million in Q1 2024 [8] - Net financial items resulted in income of $56 million in Q1 2025, down from $133 million in Q1 2024, mainly due to foreign exchange impacts from the change in functional currency [8] Outlook - Genmab is maintaining its 2025 financial guidance as published on February 12, 2025 [4] Other Matters - The functional currency of Genmab A/S has changed from DKK to USD effective January 1, 2025, with the presentation currency also changed to USD, affecting comparative figures for prior periods [5]