Genmab(GMAB) - 2025 Q4 - Earnings Call Transcript

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]