Financial Data and Key Metrics Changes - Total revenue increased by 19% to $3.7 billion in 2025, driven by strong execution across the royalty portfolio and commercialized medicines [25][26] - Operating profit expanded to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales [26][30] - Sales of proprietary medicines totaled $632 million, up 54% year-over-year, accounting for approximately 28% of total revenue growth [16][25] Business Line Data and Key Metrics Changes - Epkinly achieved $468 million in sales for 2025, representing a 67% year-over-year increase, driven by its dual indication in diffuse large B-cell lymphoma and follicular lymphoma [17][19] - Tivdak generated $164 million in sales, a 26% year-over-year increase, maintaining market leadership in recurrent or metastatic cervical cancer [20][21] Market Data and Key Metrics Changes - Epkinly closed 2025 with regulatory approvals in over 65 countries, nearly all featuring the dual indication [17] - The U.S. market saw increased uptake for Epkinly, particularly in community settings, with a majority of health systems ordering from multiple sites [18] 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, with a focus on sustainable growth into the 2030s [5][6] - The acquisition of Merus is expected to enhance the late-stage portfolio with petosemtamab, providing multiple value-creating catalysts in 2026 and beyond [8][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027, emphasizing a disciplined approach to capital allocation [31] - The company anticipates continued momentum in Epkinly and its royalty portfolio, with a revenue growth guidance of 14% for 2026 [27][30] Other Important Information - The company has five combined breakthrough therapy designations for its late-stage programs, which have multi-billion dollar potential [9] - The company is committed to deleveraging, targeting gross leverage below 3x by the end of 2027 [30] Q&A Session Summary Question: Next steps for Epkinly following EPCORE DLBCL-1 study results? - Management confirmed that the study showed positive progression-free survival but missed overall survival, and discussions with regulatory agencies are ongoing regarding the next steps [34][36] Question: Update on outpatient data for Epkinly? - Management indicated that the outpatient study is crucial for modifying the label and facilitating administration in the community [43][46] Question: Expectations for Rina-S pivotal phase two readout? - Management stated that the study is designed to support accelerated approval based on overall response rate and duration of response [51][54] Question: Expectations for EPCORE DLBCL 4 trial? - Management expressed optimism that the trial will lead to registration in second-line and third-line settings, differentiating it from other studies [58][60] Question: Thoughts on pembro approval in PROC and implications for Rina-S? - Management acknowledged the approval as a good option for patients but believes Rina-S can be more transformative for a broader population [62][64] Question: Confirmation on interim results for Epkinly frontline DLBCL trial? - Management reiterated that the readout for the study is expected to happen in 2026 [55][68]

Genmab (NasdaqGS:GMAB) Q4 2025 Earnings call February 17, 2026 12:00 PM ET Company ParticipantsAnthony Pagano - CFOBenjamin Jackson - VP of Equity ResearchBrad Bailey - CCOJames Gordon - Director and Head of European Pharma and Biotech & Life Sciences Equity ResearchJan van de Winkel - CEOJudith Klimovsky - Chief Development OfficerMatthew Phipps - Group Head–BiotechnologyTahamtan Ahmadi - CMOVictor Floc'h - Equity Research of PharmaceuticalsXian Deng - Executive Director and Pharma and Biotech Equity Resea ...

Financial Data and Key Metrics Changes - Total revenue increased by 19% to $3.7 billion in 2025, driven by strong execution across the royalty portfolio and commercialized medicines [24][25] - Operating profit expanded to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales [25][27] - Sales of proprietary medicines totaled $632 million, up 54% year over year, accounting for approximately 28% of total revenue growth [14][24] Business Line Data and Key Metrics Changes - Epkinly achieved $468 million in sales for the year, representing a 67% year-over-year increase, driven by its dual indication in diffuse large B-cell lymphoma and follicular lymphoma [15][24] - Tivdak generated $164 million in sales, representing a 26% year-over-year increase, maintaining market leadership in recurrent or metastatic cervical cancer [19][20] Market Data and Key Metrics Changes - Epkinly closed 2025 with regulatory approvals in more than 65 countries, nearly all featuring the dual indication [15] - The U.S. market saw increased uptake for Epkinly, particularly following its approval in second-line follicular lymphoma [17][18] - Tivdak's launch in Germany showed strong uptake, with positive physician feedback [20] 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][24] - The acquisition of Merus is expected to enhance the late-stage portfolio with petosemtamab, contributing to sustainable growth [6][25] - The focus for 2026 includes advancing proprietary portfolio impact, expanding market footprint, and preparing for multiple product launches [22][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 [29] - The company anticipates continued revenue growth driven by Epkinly and its royalty portfolio, with a guidance of 14% total revenue growth for 2026 [26][28] - Management highlighted the importance of maintaining substantial profitability while investing in growth opportunities [27][28] Other Important Information - The company has five combined breakthrough therapy designations for its late-stage programs, indicating multi-billion dollar potential [7] - The anticipated data readouts in 2026 are expected to set the stage for multiple important product launches and line extensions in 2027 [8][10] Q&A Session Summary Question: Next steps for Epkinly following EPCORE DLBCL-1 study results - Management confirmed that the study showed positive progression-free survival but missed overall survival, with ongoing discussions with regulatory agencies about the data [31][33] Question: Update on outpatient data for Epkinly - Management indicated that the outpatient study is crucial for modifying the label and facilitating administration in the community [40][42] Question: Expectations for Rina-S pivotal phase two readout - Management stated that the study is designed to support accelerated approval based on overall response rate and duration of response [47][49] Question: Expectations for EPCORE DLBCL-4 trial outcomes - Management expressed optimism that the trial will lead to registration in second-line and third-line settings, differentiating it from other studies [53][55] Question: Thoughts on pembro approval in PROC and implications for Rina-S - Management acknowledged the approval as a good option for patients but believes Rina-S can be more transformative for a broader population [57][59] Question: Clarification on phase 3 for petosemtamab - Management confirmed that the phase 3 studies have dual endpoints of overall response rate and overall survival, which are standard in areas of unmet medical need [75]

Core Viewpoint - Genmab A/S has decided to discontinue the clinical development of acasunlimab to focus on more promising late-stage opportunities in its portfolio [1][2]. Group 1: Clinical Development Decision - The decision to halt acasunlimab's development follows a thorough assessment of the competitive landscape and aims to concentrate resources on programs with the highest potential impact [1][2]. - Acasunlimab was involved in four cancer trials, including a Phase 3 study in non-small cell lung cancer and two Phase 2 trials in melanoma and non-small cell lung cancer [4]. Group 2: Financial Implications - The discontinuation of acasunlimab does not affect Genmab's full-year 2025 financial guidance [3]. - Analyst estimates previously modeled peak sales of approximately $300 million for acasunlimab, which was considered a minimal contribution to the company's overall revenue potential [5]. Group 3: Focus on Other Programs - Genmab will redirect its focus to other late-stage programs, including Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S), which are advancing in development [2]. - The combined peak sales potential for these three lead assets is estimated at $8 billion, indicating significant upside for Genmab [5]. Group 4: Market Reaction - Following the announcement, Genmab shares experienced a decline of 2.05%, trading at $32.73 [6].

Core Viewpoint - Genmab A/S has decided to discontinue the clinical development of acasunlimab to focus on higher-value opportunities in its late-stage pipeline, despite encouraging clinical data observed to date [1][2][7]. Group 1: Decision and Strategic Focus - The decision to halt the acasunlimab program is part of Genmab's strategic focus on maximizing value in its late-stage portfolio [1][7]. - Genmab will redirect resources towards programs with higher potential impact, specifically EPKINLY (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S), which are currently in late-stage development [1][2]. Group 2: Financial Guidance - This decision will not affect Genmab's full-year 2025 financial guidance, indicating stability in the company's financial outlook despite the program discontinuation [3][7]. Group 3: Company Background - Genmab is an international biotechnology company focused on developing innovative antibody medicines for cancer and other serious diseases, with over 25 years of experience in advancing various antibody-based therapeutic formats [4][5]. - The company has a strong late-stage clinical pipeline and aims to deliver transformative medicines to patients [4].

Core Insights - Genmab A/S has successfully completed the tender offer to acquire all outstanding common shares of Merus N.V. for $97 per share, marking a significant step in its strategy to transition to a wholly owned model and enhance revenue diversification [1][4] - The acquisition is expected to bolster Genmab's position as a global biotechnology leader, particularly through the integration of Merus' lead asset, petosemtamab, which is anticipated to have a substantial impact on head and neck cancer treatment [2][3] - Genmab projects that petosemtamab will contribute to EBITDA with an annual sales potential of at least $1 billion by 2029, with expectations for multi-billion-dollar revenue potential thereafter [3][8] Transaction Details - As of the expiration time on December 11, 2025, 71,463,077 shares of Merus, representing 94.2% of its outstanding shares, were validly tendered [4] - A subsequent offering period of ten business days has been initiated, allowing additional shares to be purchased at the same price of $97 per share [5] - Following the completion of the subsequent offering period, Genmab plans to finalize the acquisition of 100% of Merus through additional transactions [6] Strategic Fit - The addition of petosemtamab aligns with Genmab's expertise in antibody therapy development and commercialization in oncology, enhancing its late-stage pipeline [3][8] - Genmab aims to launch petosemtamab in 2027, contingent on clinical results and regulatory approvals, with plans for further development in other therapeutic areas [3]

Core Insights - Merus N.V. and Halozyme Therapeutics, Inc. have entered into a global non-exclusive collaboration and license agreement to develop and potentially commercialize the subcutaneous administration of petosemtamab, an EGFR x LGR5 bispecific antibody [1][2][3] Company Overview - Halozyme is a biopharmaceutical company known for its ENHANZE drug delivery technology, which facilitates subcutaneous delivery of injected drugs, aiming to improve patient experience and treatment efficiency [4][5] - Merus specializes in developing innovative full-length multispecific antibodies and antibody drug conjugates, referred to as Multiclonics, which have shown promising results in clinical studies [7][8] Collaboration Details - Under the agreement, Merus will make an upfront payment to Halozyme, along with potential future milestone payments based on commercial and sales achievements, if approved [3] - Halozyme is entitled to receive low to mid-single digit royalties on net sales of petosemtamab formulated with the ENHANZE technology during the royalty term [3] Clinical Potential - Petosemtamab has shown encouraging results in clinical studies across various solid tumor cancers and is positioned to potentially become a first and best-in-class treatment for head and neck cancer and other indications [2][3]

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]

Core Insights - Merus N.V. announced interim clinical data for petosemtamab, a bispecific antibody, showing promising response rates in metastatic colorectal cancer (mCRC) patients [1][2][3] Group 1: Clinical Data Summary - In the ongoing phase 2 trial, petosemtamab demonstrated a 100% response rate in first-line (1L) left-sided mCRC patients (n=8) and a 62% response rate in second-line (2L) mCRC patients (n=13) [1][3] - The trial included 54 patients with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC, treated with petosemtamab in combination with FOLFOX/FOLFIRI or as monotherapy [3] - In the 1L treatment group, 10 patients were efficacy evaluable, with 8 left-sided patients showing an 80% response rate, including 1 confirmed complete response and 7 partial responses [3][7] Group 2: Mechanism of Action and Potential Impact - Petosemtamab targets both EGFR and LGR5, which may provide a new treatment option for patients with EGFR inhibitor-naïve mCRC [2] - The early results suggest that petosemtamab could become a transformational treatment and a new standard of care for various solid tumors [2] Group 3: Safety Profile - The safety profile of petosemtamab in mCRC appears consistent with its established profile in recurrent/metastatic head and neck squamous cell carcinoma, with no significant overlapping toxicities identified [7] - Infusion-related reactions were managed effectively, with no discontinuations due to these reactions [7]

Core Insights - The article discusses the promising interim clinical data for petosemtamab, a bispecific antibody, in combination with standard chemotherapy regimens FOLFOX/FOLFIRI for metastatic colorectal cancer (mCRC) and as a monotherapy for later lines of treatment [1][2] Clinical Trial Data - As of April 28, 2025, 36 patients with microsatellite stable mCRC received petosemtamab 1500 mg Q2W, either in combination with FOLFOX/FOLFIRI or as monotherapy [2] - In the 1L treatment group, 7 patients were treated, with 3 being efficacy evaluable, showing 1 unconfirmed complete response and 2 partial responses [2] - In the 2L treatment group, 10 patients were treated, with 8 being efficacy evaluable, resulting in 4 partial responses and 3 stable diseases [2] - In the 3L+ monotherapy group, 19 patients were treated, with 14 being efficacy evaluable, showing 1 unconfirmed partial response and 6 stable diseases [2] Safety Profile - No fatal treatment-related adverse events (TEAEs) were observed across all cohorts [2] - Common TEAEs for petosemtamab plus FOLFOX included dermatitis acneiform (71%), constipation (43%), fatigue (43%), and peripheral neuropathy (43%) [2] - Common TEAEs for petosemtamab plus FOLFIRI included diarrhea (70%), mucosal inflammation (50%), and fatigue (40%) [2] - For petosemtamab monotherapy, frequent TEAEs included rash (58%) and nausea (26%) [7] Upcoming Presentations - The updated clinical data will be presented in a plenary session on October 24, 2025, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [3]