Denmark · Delayed Price · Currency is DKK Genmab Earnings Call Transcripts
Fiscal Year 2026
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Q1 2026 saw 25% revenue growth and 23% operating profit growth, led by strong EPKINLY and TIVDAK sales. Rina-S phase III enrollment finished early, supporting accelerated filings, while guidance for 14% revenue growth and substantial profitability in 2026 was reaffirmed.
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Three late-stage assets are set for pivotal readouts in 2026, with strong commercial and financial prospects driven by robust clinical data and expansion into broader patient populations. Direct commercialization in key markets and ongoing R&D are expected to sustain growth beyond the loss of major royalties.
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Strong financial performance and late-stage pipeline progress set the stage for major 2026 milestones, including pivotal trial readouts for EPKINLY, Rina-S, and petosemtamab. Commercial infrastructure is ready for launches in 2027, with each program targeting multi-billion dollar opportunities.
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Strong recurring revenue growth and disciplined OpEx management are expected to continue through 2027, with EPKINLY driving near-term growth and new launches for Rina-S and Petosemtamab anticipated to contribute meaningfully from 2028. Peak sales targets for late-stage assets are set to offset potential royalty declines, while deleveraging and profitability remain key priorities.
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A diversified late-stage pipeline and disciplined capital allocation position the business for sustainable growth, with 2026 expected to deliver pivotal data readouts for Epkinly, Rina-S, and petosemtamab. Integration of Merus assets and operational efficiencies support multiple high-impact launches in 2027.
Fiscal Year 2025
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Revenue grew 19% to $3.7B in 2025, with proprietary medicines up 54% and operating profit at $1.26B. EPKINLY, TIVDAK, and Rina-S drove growth, while the Merus acquisition added petosemtamab. 2026 guidance targets 14% revenue growth and continued investment in late-stage assets.
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Transformative data for epcoritamab-based regimens in lymphoma drive regulatory approvals and commercial expansion. Strategic acquisitions and late-stage pipeline growth position for multiple pivotal readouts and new product launches in 2026–2027.
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Late-stage oncology programs are advancing with key data readouts in 2026 and potential launches in 2027, supported by strong financial growth and disciplined capital allocation. The Merus acquisition and robust clinical pipeline position the business for significant expansion, with Epkinly, RENA-S, and PETO targeting multi-billion dollar peak sales.
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Late-stage assets Epkinly, Rina-S, Acasunlimab, and Petosemtamab are prioritized, with strong clinical data supporting their advancement. 2026 will be an investment year, targeting major launches in 2027 and significant EBITDA growth by 2029, driven by robust sales projections for Peto and Rina-S.
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Revenue grew 21% and operating profit 52% year-over-year, driven by strong recurring revenue and product sales. Late-stage pipeline advanced, with Epkinly and TIVDAK sales up 54% and a proposed Merus acquisition to diversify the portfolio. Guidance for double-digit growth remains on track.
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The acquisition of Merus for $8 billion brings a high-potential, FDA-designated breakthrough therapy (PETO) into the late-stage pipeline, accelerating the shift to a fully integrated biotech model. PETO is expected to launch in 2027, driving multibillion-dollar revenue and long-term growth.
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Strong 2025 performance is driven by late-stage oncology assets EPKINLY and Rina-S, with both showing compelling clinical data and upgraded peak sales targets. EPKINLY's phase III readouts and Rina-S's expansion in gynecological cancers are key near-term catalysts.
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The conference highlighted robust late-stage clinical progress for EPKINLY and RINASCE, with strong commercial momentum and plans for global expansion. Strategic capital allocation, AI integration, and a focus on innovation and partnerships position the company for sustained growth.
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Revenue grew 19% and operating profit 56% in H1 2025, driven by strong sales of EPKINLY and Tivdak, robust royalties, and disciplined investment in late-stage programs. Upgraded guidance reflects continued momentum, with key clinical milestones achieved for epcoritamab and Rina-S.
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Strong Q1 results and ASCO data highlight robust growth, with Epkinly and Rina-S leading a diverse pipeline. Multiple late-stage trials and new indications support upgraded sales guidance, while risk management and capital allocation remain key priorities.
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Significant progress was highlighted across late-stage oncology assets, with Rina-S showing strong efficacy in ovarian and endometrial cancers and EPKINLY advancing in lymphoma. Key data updates and regulatory milestones are expected by year-end and into 2026.
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Rinatabart Sesutecan showed strong efficacy and durable responses in ovarian and endometrial cancers, with a favorable safety profile and activity across all folate receptor alpha expression levels. Multiple pivotal trials are ongoing or planned, with broad expansion into solid tumors and peak sales projected above $2 billion.
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Revenue grew 19% year-over-year, driven by EPKINLY and Tivdak, with operating profit up 62%. Strong recurring revenues, robust pipeline progress, and new regulatory approvals support a positive outlook, with 2025 guidance reaffirmed and a share buyback underway.
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Portfolio focus shifts away from HexaBody-CD38, with strategic emphasis on late-stage assets EPKINLY, Rina-S, and Acasunlimab, all expected to drive significant revenue growth. The HexaBody platform is validated for future programs, and financial guidance for 2025 remains unchanged.
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Capital allocation is focused on late-stage R&D, with significant investment in EPKINLY, Rina-S, and Acasunlimab. Commercial expansion in Europe and Japan is underway, leveraging TIVDAK rights and preparing for Rina-S launches. Multiple phase 3 trials and new pipeline assets are advancing, with strong financial growth and a robust royalty business supporting future innovation.
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A robust pipeline, strong financials, and recent acquisitions position the company to accelerate growth and innovation, with a focus on late-stage oncology assets and a trend toward greater ownership. Partnerships and disciplined investment remain central to achieving the 2030 vision.
Fiscal Year 2024
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Achieved 31% revenue growth and 26% operating profit growth in 2024, driven by strong sales of EPKINLY, Tivdak, and DARZALEX. Guidance for 2025 projects continued double-digit growth, with major investments in late-stage R&D and a new $370 million share buyback.
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Significant regulatory and clinical milestones were achieved, including multiple approvals and robust late-stage trial progress for Epkinly and Rina-S. Clinical data showed high response rates and durable remissions across lymphoma and ovarian cancer indications, with manageable safety. Key 2025 milestones include regulatory decisions, data updates, and pipeline expansion.
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Focused on antibody-based oncology, the company advances seven phase 3 trials across key assets, with Epkinly, Rina-S, and Axonimab driving future growth. Strategic investments in commercialization and disciplined capital allocation support expansion, while a robust royalty portfolio underpins long-term prospects.
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Epkinly continues to outperform in key markets, with broad expansion plans and multiple phase III trials underway. Acasunlimab advances to phase III with full ownership, while the ProfoundBio acquisition strengthens the ADC pipeline. Financial discipline and program prioritization remain central for 2025.
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Strong revenue and profit growth driven by EPKINLY, Tivdak, and royalty streams, with expanded late-stage pipeline and strategic portfolio prioritization. Guidance for 2024 was raised, and significant new approvals and clinical milestones were achieved.
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The business is evolving into an integrated innovation leader, accelerating late-stage development and commercialization, especially for ADCs like Rina-S and immune activators. Key milestones ahead include pivotal trial starts, broadening indications, and major data releases for Rina-S, acasunlimab, and GEN3014.
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ProfoundBio acquisition and strong H1 revenue growth drove raised full-year guidance. Key products like DARZALEX, Kesimpta, Epkinly, and Tivdak delivered robust performance, while two wholly owned assets advance to late-stage development.
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The event highlighted robust commercial growth, pipeline advancements, and strategic integration of ProfoundBio, with key data updates and registration trials for Rina-S and GEN1046 expected in the second half of 2024. EPKINLY and TIVDAK continue to drive revenue, while DARZALEX maintains a strong market position.
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Tisotumab vedotin, epcoritamab, and acasunlimab all showed promising efficacy and safety in mid- to late-stage trials, with regulatory submissions and phase III initiations underway. Acasunlimab plus pembrolizumab achieved unprecedented survival in NSCLC, and mitigation strategies have improved safety.