Genmab A/S (GMAB) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights strong future revenue projections, significant product pipeline developments, and strategic market expansions, which are positive indicators. The Q&A section reveals management's optimism about trial outcomes and market strategies, despite some vagueness in responses. The company's focus on strategic acquisitions and disciplined financial management further supports a positive outlook. However, the lack of interim trial details could cause some uncertainty. Overall, the strong revenue and product potential, combined with strategic growth plans, suggest a positive stock price movement in the short term.
Key Financial Performance
Total Revenue $3.7 billion, a 19% increase year-over-year, driven by strong execution across the royalty portfolio and progress in commercialized medicines.
Operating Profit $1.26 billion, reflecting an increase due to strong execution and increasing operating leverage as the business scales.
Sales of Proprietary Medicines $632 million, a 54% increase year-over-year, accounting for approximately 28% of total revenue growth.
EPKINLY Sales $468 million, a 67% increase year-over-year, driven by growth across geographies and its dual indication approval in diffuse large B-cell lymphoma and follicular lymphoma.
TIVDAK Sales $164 million, a 26% increase year-over-year, attributed to its recognition as the global standard of care in recurrent or metastatic cervical cancer.
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Operating Highlights
EPKINLY: Continued momentum as a core therapy in B-cell lymphomas, FDA approval in second-line follicular lymphoma, and unprecedented data in this indication. Positioned to become a best-in-class option in second-line plus follicular lymphoma.
Rina-S: Expanded development with 3 Phase III trials across PROC, endometrial cancer, and PSOC. Designed to broaden eligibility beyond high folate receptor alpha expressers, potentially tripling the addressable population.
Petosemtamab: Acquisition of Merus added this late-stage asset. Demonstrated compelling data in first-line and later-line recurrent/metastatic head and neck cancer, with a 63% response rate in combination with pembro in first-line setting.
Geographic Expansion: Expanded operations to Germany, the U.K., and France. TIVDAK approved in the EU, U.K., and Japan for recurrent/metastatic cervical cancer. EPKINLY approved in over 65 countries with dual indications.
Commercialization Model: Successfully executed 4 key launches, 2 led entirely by Genmab. Built infrastructure in Europe, Japan, and the U.S., demonstrating capability to scale in new markets.
Revenue Growth: Total revenue grew by 19% to $3.7 billion in 2025, driven by royalty portfolio and proprietary medicines. Proprietary medicines accounted for $632 million, a 54% year-over-year increase.
Profitability: Operating profit expanded to $1.26 billion despite strategic investments. Maintained substantial profitability while funding growth.
Pipeline Development: Focused on advancing late-stage assets (EPKINLY, Rina-S, and petosemtamab) with multiple registrational data readouts expected in 2026, setting the stage for 2027 launches.
Capital Allocation: Invested in commercialization capabilities and late-stage pipeline while maintaining profitability. Targeting gross leverage below 3x by 2027.
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Risk or Challenges
Delayed or unsuccessful development projects: The company acknowledges that actual results may differ materially due to delayed or unsuccessful development projects, which could impact their ability to meet strategic objectives.
Regulatory hurdles: The company faces challenges in engaging with global regulatory authorities for approvals and next steps, particularly for EPKINLY and other therapies.
Economic uncertainties: The company is exposed to economic uncertainties, including the potential impact of COVID-19 and the increasing availability of novel anti-lymphoma therapies, which could affect trial outcomes and market dynamics.
Supply chain and operational risks: The company is expanding its footprint in new markets, which involves building infrastructure and scaling operations, posing risks related to execution and operational efficiency.
Competitive pressures: The company faces competitive pressures from other therapies in the oncology space, particularly in the areas of B-cell malignancies and cervical cancer.
Strategic execution risks: The company is making significant investments in late-stage development and launch readiness activities, which require disciplined execution to ensure profitability and long-term growth.
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Guidance & Outlook
Revenue Growth: 2026 guidance reflects a 14% total revenue growth, driven by continued momentum in EPKINLY and the royalty portfolio. DARZALEX net sales are expected to range between $15.6 billion to $16.4 billion.
Product Launches and Data Readouts: 2026 will feature up to 6 potentially registrational data readouts for EPKINLY, Rina-S, and petosemtamab, setting the stage for multiple product launches and line extensions in 2027.
EPKINLY Development: Key data readouts in 2026 for EPKINLY include Phase III trials in diffuse large B-cell lymphoma (DLBCL) and second-line follicular lymphoma (FL). The addressable patient population for EPKINLY is expected to grow from 27,000 to 150,000 by early next decade.
Rina-S Development: Phase II data for Rina-S in platinum-resistant ovarian cancer is expected in the second half of 2026.
Petosemtamab Development: Phase III trials for petosemtamab in first-line and later-line head and neck cancer are anticipated to deliver top-line data in the second half of 2026.
Profitability and Investments: 2026 guidance includes a planned increase in operating expenses to support late-stage development and launch readiness for petosemtamab and Rina-S, while maintaining substantial profitability with $1.15 billion operating profit at the midpoint.
Market Expansion: EPKINLY is expected to achieve approvals in second-line FL in Europe and Japan in 2026, further strengthening its market position.
Long-term Growth: The company is targeting sustainable growth into the 2030s, supported by strategic investments and a diversified late-stage pipeline.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you discuss what the next steps are for EPKINLY following the results of the EPCORE DLBCL-1 study? Can you still get the second line plus label with the EPCORE DLBCL-4 combination study? And what was the rationale behind using the monotherapy DLBCL-1 study as the confirmatory study?
A:The next steps involve discussions with the FDA, European, and global health authorities regarding the data set, which was positive for PFS but confounded on OS due to COVID and access to bispecifics. The rationale for using the DLBCL-1 study as the confirmatory study was its initiation as the first Phase III study, meeting the requirement for accelerated approval. Discussions are ongoing for other Phase III studies, including the EPCORE DLBCL-4 combination study, which is expected to read out this year and was initiated after the Omicron wave.
Q:You presented EPCORE outpatient data late last year. How has this data been adapted to change in practice in the U.S.? What proportion of community clinics are still sending DLBCL patients to large centers for step-up dose monitoring? What is the likelihood of convincing regulatory agencies to consider other EPCORE Phase III study readouts as confirmatory studies?
A:The outpatient study was designed to facilitate administration in community settings and modify the label language. The company is confident in the likelihood of regulatory agencies considering other Phase III study readouts as confirmatory studies, given the precedent set by other programs and the ongoing Phase III studies.
Q:Given the pivotal Phase II for Rina-S is due to come out this year, what determines when you can decide to have a readout? Can you confirm whether the EPKINLY frontline DLBCL trial has passed the interim?
A:The pivotal Phase II for Rina-S is designed for ORR and duration of response, which are validated endpoints for clinical benefit. The EPKINLY frontline DLBCL trial is expected to read out in 2026, and no further details on interim results were provided.
Q:What are your expectations for the EPCORE DLBCL-4 trial? What do you think is a clinically meaningful outcome, especially relative to LUNSUMIO and POLIVY?
A:The expectation is that the trial will be positive and lead to registration in second and third lines. It is differentiated by being a registrational trial with a combination regimen initiated after the Omicron wave, addressing confounders seen in other studies.
Q:What are your thoughts on the pembro approval in PROC and its implications for Rina-S? What are your high-level thoughts on the DARZALEX trajectory over the coming years?
A:The pembro approval in PROC is seen as a good option for patients but limited to PD-L1 positive CPS ≥1% and includes chemotherapy. Rina-S is expected to be more transformative, serving a broader population. DARZALEX is expected to continue its positive trajectory, supported by data in combination with bispecifics.
Q:What are you hoping to see in the EPKINLY first-line DLBCL trial in terms of OS benefit? What is the efficacy bar relative to POLIVY and MONJUVI?
A:The primary endpoint is PFS, with expectations of transformative results based on robust Phase II data. OS is a secondary endpoint, and the company anticipates exceeding current reported Phase III data sets for other agents.
Q:Can you clarify the events tracking for the EPKINLY first-line DLBCL trial? Have you spoken to the FDA about the trial design for the ongoing Phase III trials for the Merus acquisition?
A:No specific details on events tracking were provided. The company is confident in the dual endpoints (ORR and OS) for the ongoing Phase III trials and believes they align with regulatory standards for areas of unmet medical need.
Q:Should we expect a Phase I/II data update for peto in head and neck cancer this year? What are your expectations for duration metrics and survival?
A:The last readout for the peto-pembro combination was informative, showing 79% 12-month OS. The company believes the data already presented is sufficient to inform the probability of success for the Phase III trial.
Q:Would you consider a trial design for peto similar to OrigAMI-5, combining KEYTRUDA and chemo in first-line non-small cell lung cancer?
A:The company stands by the chemo-free combination of peto and pembro, which has shown unprecedented ORR and CR rates. While other directions may be explored, the current strategy is seen as a strong value proposition for patients.
Q:Is the petosemtamab Phase II trial in first-line non-small cell lung cancer a new trial? What are your expectations for this study?
A:The trial is a signal-seeking study targeting EGFR in lung cancer, leveraging the synergy between peto and pembro. Updates will be provided as data becomes available.
Q:Is the additional Phase III for peto in 2026 the locally advanced trial? Will there be updates on the colorectal cancer cohorts?
A:Yes, the additional Phase III is the locally advanced head and neck trial. The colorectal cancer cohorts are growing, and updates will be shared as the data matures.
Q:What are your priorities for the early-stage pipeline, and do you have enough candidates in-house? Should we expect early-stage M&A?
A:The company has filed 3 INDs recently, including bispecifics and ADCs, and is focused on next-generation platforms. While internal capabilities are prioritized, external innovation and early-stage M&A remain possibilities.
Q:What additional information is needed to specify the peak sales potential for peto?
A:The company reiterates the multibillion-dollar potential for peto, with pivotal readouts expected in 2026. Further data and refined clinical development plans will inform future updates on sales potential.
Q:What is the size of the opportunity for Rina-S, and can you clarify the terms of the debt offering?
A:Rina-S has a peak sales potential of $2 billion+, supported by ongoing Phase III trials in multiple indications. The debt offering totals $5.5 billion, with a weighted average effective interest rate of 6.6%, and the company aims to reduce gross leverage below 3x by 2027.
Q:What are your thoughts on sales and marketing investments ahead of potential launches?
A:The company is disciplined on OpEx and strategically investing in commercialization efforts. Current teams in the U.S., Japan, and Europe are strong, with plans to scale as needed.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on events tracking for the EPKINLY first-line DLBCL trial and did not clarify interim results. Additionally, they did not specify what constitutes a 'positive' outcome for certain trials, using vague language like 'transformative' and 'exciting' without concrete metrics.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
EPKINLY Rina
Europe Japan
III trial
Jan
Japan traction
Merus
Phase III
Rina petosemtamab
TIVDAK Japan
TIVDAK market
UK
availability
base
brand
capital allocation
commercialization model
footprint
framework
improvement progression
increase investment
leverage
line FL
lymphoma indication
market opportunity
market presence
milestone
model Japan
momentum EPKINLY
monotherapy result
patient foundation
population
product launch
program slide
readiness
readout
royalty portfolio
sale medicine
stage portfolio
survival
today expansion
traction line
trajectory
GMAB Transcript
Genmab A/S (GMAB) Q4 2025 Earnings Call Transcript
Positive2-17
The earnings call highlights strong future revenue projections, significant product pipeline developments, and strategic market expansions, which are positive indicators. The Q&A section reveals management's optimism about trial outcomes and market strategies, despite some vagueness in responses. The company's focus on strategic acquisitions and disciplined financial management further supports a positive outlook. However, the lack of interim trial details could cause some uncertainty. Overall, the strong revenue and product potential, combined with strategic growth plans, suggest a positive stock price movement in the short term.
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