2025 Annual Report
Leading Antibody Science for Better Futures
CVR No. 21 02 38 84 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 2
Table of Contents
1 The Sustainability Statements are part of Management's Review
Management's Review
Our 2030 Vision
Chair's Statement
Letter from the CEO
2025 at a Glance
Consolidated Key Figures
2026 Outlook
Who We Are
Business Model
Value Chain
Research and Development Capabilities
16 Expanding the Reach of Our Medicines
18 Antibody Discovery and Development
20 Products and Technologies
37 Financial Review
48 Risk Management
49 Enterprise Risk Management
54 Corporate Governance
56 Executive Management
57 Board of Directors
60 Shareholders and Share Information
Sustainability Statements163 General information
73 Environmental
81 Social
98 Governance
103 Appendix A
Financial Statements
105 Financial Statements for The Genmab Group
158 Financial Statements of The Parent Company
173 Directors' and Management's Statement on the Annual Report
174 Independent Auditor's Reports
Other Information180 Forward Looking Statement
181 Contact Information
Our Reporting Suite
2025 Corporate Governance Report 2025 Compensation Report
Our Corporate Governance and Compensation Reports for 2025 can also be found on our website Genmab.com.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 3
Management's Review
In this section Sustainability Statements
4 | Our 2030 Vision | 63 | General information |
5 | Chair's Statement | 73 | Environmental |
6 | Letter from the CEO | 81 | Social |
8 | 2025 at a Glance | 98 | Governance |
9 | Consolidated Key Figures | 103 | Appendix A |
10 | 2026 Outlook | ||
11 | Who We Are | ||
12 | Business Model | ||
13 | Value Chain | ||
14 | Research and Development Capabilities | ||
16 | Expanding the Reach of Our Medicines | ||
18 | Antibody Discovery and Development | ||
20 | Products and Technologies | ||
37 | Financial Review | ||
48 | Risk Management | ||
49 | Enterprise Risk Management | ||
54 | Corporate Governance | ||
56 | Executive Management | ||
57 | Board of Directors | ||
60 | Shareholders and Share Information |
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 4
Our 2030 Vision
By 2030, our KYSO antibody medicines® are fundamentally transforming the lives of people with cancer and other serious diseases.
Our Core Purpose, Supporting Our 2030 Vision
Our unstoppable team will improve the lives of patients through innovative and differentiated antibody therapeutics.
Over 25 Years of Innovation
1999 - 2009 2010 - 2020 2021 - 2025
Genmab founded
Nasdaq Copenhagen A/S (Nasdaq Copenhagen) Initial Public Offering (IPO)
First partnership (F. Hoffmann-La Roche AG (Roche))
Ofatumumab program announced
Daratumumab selected
Arzerra®1 (ofatumumab) first approval
DuoBody® technology platform announced
Collaboration with Seagen Inc. (Seagen)
DuoBody research and license agreement with Johnson & Johnson (J&J, legal entity Janssen Biotech, Inc.)
Daratumumab agreement with J&J
DARZALEX®2 (daratumumab) approval and launch
U.S. IPO under Nasdaq Global Select Market; dual listed as GMAB
Japan Operations established under Genmab K.K.
AbbVie Inc. (AbbVie) partnership
DARZALEX FASPRO®2 (daratumumab and hyaluronidase fihj) approval and launch
Kesimpta®3 (ofatumumab) approval and launch
TEPEZZA®4 (teprotumumab) approval and launch
Tivdak®5 (tisotumab vedotin-tftv) initial approval and launch in the US for recurrent or metastatic cervical cancer
DuoBody-based bispecifics RYBREVANT®2 (amivantamab), TECVAYLI®2 (teclistamab) and TALVEY®2 (talquetamab) approval and launch
DuoBody-based bispecific EPKINLY®6 (epcoritamab-bysp)/ TEPKINLY®6 (epcoritamab) initial approvals and launches in relapsed/ refractory diffuse large B-cell lymphoma (DLBCL) in US, Europe and Japan
ProfoundBio Inc. (ProfoundBio) acquisition, including rinatabart sesutecan (Rina-S®)
Rina-S moves into Phase 3 development in platinum resistant ovarian cancer (PROC)
Rina-S granted Breakthrough Therapy designation (BTD) by the
U.S. Food and Drug Administration (FDA) in advanced endometrial cancer
EPKINLY approval and launch in relapsed/refractory follicular lymphoma (FL) in US, Europe and Japan
Tivdak approved in Europe and Japan for recurrent or metastatic cervical cancer
EPKINLY approval in US in combination with rituximab and lenalidomide (R2) for relapsed/ refractory FL
Rina-S expands Phase 3 development into endometrial cancer and platinum sensitive ovarian cancer (PSOC)
Genmab acquisition of Merus
N.V. (Merus), including petosemtamab
1. Developed and commercialized by GlaxoSmithKline (GSK); 2. Developed and commercialized by J&J; 3. Developed and commercialized by Novartis AG (Novartis); 4. Developed and commercialized by Amgen Inc. (Amgen); 5. Co-developed and commercialized with Pfizer Inc. (Pfizer); 6. Co-developed and commercialized with AbbVie
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 5
Chair's Statement
Deirdre P. Connelly
Board Chair Dear Shareholder,
As we close another successful year, we reflect on our progress and growth. The past year
has been one of intentional transformation, marked by a strengthening pipeline and meaningful steps toward our long-term goals. Genmab remains committed to its purpose: to improve the lives of patients with cancer
and other serious diseases through innovative and differentiated antibody therapeutics.
Genmab's EvolutionGenmab is celebrating another transformational year. With the acquisition of Merus, a clinical-stage biotechnology company with late-stage breakthrough asset petosemtamab, Genmab has taken another important step - this strategic move accelerates our transition to a fully integrated biotech company. We continue to strengthen our position as a global leader in antibody therapeutics, driven by the strength
of our science and our unstoppable team.
Empowering Our PeopleIn this exciting time of change, it is crucial that Genmab maintains and grows our team to create value for the years to come. Our colleagues are the foundation of our achievements and sustain our innovation.
This year, Genmab surpassed 3,000 employees in eight countries, reflecting our commitment
to building a diverse, multicultural and high-performing organization.
Experienced LeadershipIn 2025 Genmab further strengthened its Executive Management team with the
appointment of Greg Mueller as General Counsel and Chief Legal Officer. Mr. Mueller will lead global legal affairs, intellectual property rights, corporate secretary and global compliance and risk functions. Bringing more than 20 years of experience, Greg joins a robust leadership team, guiding Genmab through its next phase of growth to a fully integrated biotech company.
Our Board of Directors, comprised of experts in their fields, also saw a change this year. Michael Kavanagh was elected to the Board by fellow employees at Genmab's 2025 Annual General Meeting, linking the workforce and Genmab's governing body.
Looking AheadThe year ahead will bring new opportunities and challenges, but with our talented team, strong leadership, and clear strategic vision, we are well positioned to continue making
a meaningful difference.
On behalf of the Board, I thank Genmab's dedicated team members, Chief Executive Officer Jan van de Winkel and the global leadership team for their extraordinary contributions, and our shareholders for your continued support.
Sincerely,
Deirdre P. ConnellyBoard Chair
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 6
Letter from the CEO
Jan van de Winkel
Ph.D. President & CEO Dear Shareholder,
As we look back on 2025, I am proud of how Genmab advanced our strategy, strengthened our foundation, and stayed true to our purpose: improving the lives of patients through innovative, differentiated antibody medicines. We entered the year focused on disciplined execution and ended it poised for our next decade of sustainable growth.
Acquisition of MerusA pivotal step on that journey is our acquisition of Merus. This transaction enhances our late-stage portfolio with petosemtamab, a potential
first-in-class bispecific for head and neck cancer with two BTDs from the FDA, reflecting its potential to meaningfully improve outcomes
for patients.
Importantly, Merus strengthens, not changes, our strategy as it accelerates our shift toward a fully integrated, 100%-owned medicines model. The addition of petosemtamab to
our pipeline diversifies our sources of future revenue, reduces our dependence on royalties over time, and enhances our flexibility to invest in the "next winners" emerging from
our research and development (R&D) engine. With petosemtamab joining EPKINLY (epcoritamab) and Rina-S, we have a strong pipeline of late-stage assets that will provide us with multiple value-creating catalysts in the coming years.
Transforming Science Into MedicineOur late-stage portfolio made meaningful strides in 2025. EPKINLY continued to demonstrate
the potential to become a core therapy in B-cell lymphomas with its FDA approval in second-line FL in combination with R2, as well as the unprecedented data in this indication, highlighted during an oral presentation at the 2025 prestigious American Society of Hematology (ASH) Annual Meeting. Together, these milestones move treatment into earlier lines of therapy and expand our impact for people living with FL.
Our other commercialized medicine, Tivdak (tisotumab vedotin), was approved in Europe and Japan for recurrent or metastatic cervical cancer after prior therapy, and these became our first independent Genmab launches.
These launches, and the offices we have now opened in Germany, the United Kingdom (UK) and France, lay the groundwork for a broader Genmab commercial footprint and deepen our commitment to the gynecologic oncology community.
We will further build on this commitment with our advancement of Rina-S. In addition
to encouraging clinical data presented in both PROC and endometrial cancer, the FDA granted BTD for Rina-S in 2025, in recurrent or progressive endometrial cancer. This support from the FDA provides confidence for our expanded development for Rina-S, as we
ended the year with three Phase 3 trials across PROC, endometrial cancer and PSOC.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 7
Letter from the CEO
A Strong Financial Foundation To Enable Our EvolutionOur financial performance this year has been a testament to the strength of our strategy. Revenue grew significantly, driven by royalties from our collaborations as well as sales of our own medicines. We anticipate this trend will continue into the future. We look forward to both expanded indications for EPKINLY and the potential for Rina-S and petosemtamab
to launch in 2027, as well as due to the expansion of our royalty medicines. In 2025, J&J's subcutaneous (SC) DARZALEX (daratumumab and hyaluronidase fihj) became the first and only treatment approved in both the US and Europe for patients with high-risk smoldering multiple myeloma. The landmark approvals support earlier intervention before the disease progresses to active multiple myeloma. Also this year Novo Nordisk A/S (Novo Nordisk) submitted a Biologics License Application (BLA) to the FDA for Mim8, also known as denecimig, a DuoBody-based investigational prophylaxis treatment for people living with hemophilia A
with or without inhibitors. If approved, denecimig
would become the ninth approved medicine created using Genmab's technology and innovation.
Acknowledgments and OutlookLooking ahead, our priorities are clear:
Integrate Merus to preserve momentum on the petosemtamab program and prepare for potential launch in 2027.
Accelerate the development of our late-stage pipeline, delivering key clinical readouts across our late-stage portfolio, especially
for epcoritamab and Rina-S, while preparing for potential label expansions and launches.
Continue to deliver on our capital allocation priorities, maintaining financial discipline while focusing our investments on the highest-growth opportunities.
With EPKINLY, Rina-S and petosemtamab, we believe Genmab is positioned to deliver
multiple potential launches and label expansions over the next several years, deepen our leadership in antibody innovation, and create durable, long-term value.
Our progress this year reflects the passion of our people, the strength of our partnerships, and the confidence of our shareholders. Looking ahead, we are energized by the opportunities before us.
With a resilient financial foundation, a
world-class team, and a differentiated late-stage pipeline, we believe Genmab is positioned to deliver durable growth and, most importantly, better futures for patients in the years ahead.
Sincerely yours,
Jan van de Winkel, Ph.D.President & CEO
2025 at a Glance
Operational
EPKINLY (epcoritamab-bysp) moves into earlier lines of therapy in FL with FDA approval in combination with R2, based on Phase 3 EPCORE® FL-1
Epcoritamab Phase 3 EPCORE FL-1 trial met dual primary endpoints of overall response rate (ORR) and progression free survival (PFS), demonstrating statistically significant and clinically meaningful differences in both endpoints, basis for global regulatory submissions
Acquisition of Merus, including its late-stage breakthrough therapy asset petosemtamab, which provides additional transformational opportunity
Tivdak (tisotumab vedotin) approved in Europe and Japan for recurrent or metastatic cervical cancer, first independent Genmab launches, laying groundwork for future
Rina-S expands Phase 3 development beyond PROC, into endometrial cancer and PSOC
Rina-S granted BTD by the FDA
Approvals in the US and Europe for J&J therapy, SC DARZALEX in smoldering multiple myeloma
Submission of BLA for Novo Nordisk's DuoBody-based denecimig
Continued development of Genmab's broader organizational infrastructure with the addition of over 300 new colleagues
Sustainability
EnvironmentalAchieved a 56% reduction in Scope 1 and market-based Scope 2 greenhouse gas (GHG) emissions
Achieved 99% renewable electricity across all sites
Developed a sustainability roadmap to meet both short- and long-term GHG emission reduction targets
SocialMet life sciences industry benchmark for favorability rate and exceeded for participation rate for Global Employee Engagement Survey
Rate of recordable work-related accidents
Financial Operating Profit
USD USD USD (USD Million)
20.5B 3,720M 2,219M
2025 year-end market cap 2025 revenue 2025 adjusted operating expenses1, 72% invested in
972
1,065
(accidents per million hours worked) at 0.4
100% of eligible team members with access to year-end performance process
Training available to all team members at varying degrees
GovernanceLiquidity and Capital Resources
USD USD
1,715M 5,847M
Cash and cash equivalents Shareholders' equity
R&D
469
865
772
Code of Conduct applies to all Genmab team members
2021 2022 2023 2024 2025
1. Operating Expenses exclude 2025 charges related to: 1) acquisition and integration-related charges of $185 million and 2) amortization of intangible assets acquired through acquisitions of $13 million.
Consolidated Key Figures
Revenue
(USD million)
3,720
3,121
2,031
2,390
1,337
2021
2022
2023
2024
2025
Operating Expenses
(USD million)
868
204
664
1,166
379
787
2021
2022
2023
2024
2025
Research and development ◼ Selling, general and
expenses
administrative expenses
Acquisition and integration
related charges
FTE at Year End
3,029
2,204
2,682
1,212
1,660
2021
2022
2023
2024
2025
Income Statement | |||||
Revenue | 1,337 | 2,031 | 2,390 | 3,121 | 3,720 |
Cost of product sales | - | - | (33) | (143) | (238) |
Research and development expenses | (664) | (787) | (1,107) | (1,414) | (1,606) |
Selling, general and administrative expenses | (204) | (379) | (478) | (549) | (626) |
Acquisition and integration related charges | - | - | - | (43) | (185) |
Total costs and operating expenses | (868) | (1,166) | (1,618) | (2,149) | (2,655) |
Operating profit | 469 | 865 | 772 | 972 | 1,065 |
Net financial items | 153 | 96 | 45 | 354 | 139 |
Net profit | 470 | 750 | 631 | 1,133 | 963 |
Balance Sheet | |||||
Total non-current assets | 300 | 273 | 320 | 2,514 | 9,988 |
Marketable securities | 1,650 | 1,783 | 1,967 | 1,574 | - |
Cash and cash equivalents | 1,423 | 1,419 | 2,204 | 1,380 | 1,715 |
Total assets | 3,899 | 4,321 | 5,232 | 6,414 | 12,873 |
Borrowings | - | - | - | - | 5,274 |
Share capital | 10 | 10 | 10 | 10 | 10 |
Shareholders' equity | 3,405 | 3,915 | 4,687 | 5,137 | 5,847 |
Cash Flow Statement | |||||
Investment in acquisitions, net of cash acquired | - | - | - | (1,783) | (7,215) |
Cash flow from operating activities | 354 | 555 | 1,071 | 1,126 | 1,186 |
Cash flow from investing activities | (153) | (392) | (185) | (1,447) | (5,643) |
Cash flow from financing activities | (67) | (110) | (89) | (566) | 4,789 |
Investments in intangible assets | - | - | (1) | (17) | (18) |
Investments in tangible assets | (40) | (45) | (53) | (27) | (37) |
Financial Ratios and Other | |||||
Basic net profit per share | 7.19 | 11.47 | 9.67 | 17.66 | 15.50 |
Diluted net profit per share | 7.12 | 11.36 | 9.58 | 17.53 | 15.37 |
Year-end share market price | 2,630.00 | 2,941.00 | 2,155.00 | 1,492.50 | 2,027.00 |
Price/book value | 7.72 | 7.51 | 4.60 | 2.91 | 3.47 |
Shareholders' equity per share | 340.50 | 391.50 | 468.70 | 513.70 | 584.70 |
Equity ratio | 87 % | 91 % | 90 % | 80 % | 45 % |
Shares outstanding | 65,718,456 | 65,961,573 | 66,074,535 | 66,187,186 | 64,238,408 |
Average number of employees (FTE)¹ | 1,022 | 1,460 | 2,011 | 2,535 | 2,694 |
Number of employees (FTE) at year-end | 1,212 | 1,660 | 2,204 | 2,682 | 3,029 |
(USD Millions) 2021 2022 2023 2024 2025
2,417 | ||||
2,006 | 185 | |||
1,585 | 43 549 | 626 | ||
478 | ||||
1,107 | 1,414 | 1,606 | ||
1. Full-time equivalent (FTE) or team member
(USD millions) | 2025 Actual Result | 2025 Adjusted Result2 | 2026 Guidance2 | 2026 Guidance Mid-Point2 |
Revenue | 3,720 | 3,720 | 4,065 - 4,395 | 4,230 |
Royalties | 3,102 | 3,102 | 3,440 - 3,685 | 3,563 |
Net product sales/ Collaboration revenue1 | 468 | 468 | 490 - 555 | 522 |
Milestones/ Reimbursement revenue | 150 | 150 | 135 - 155 | 145 |
Gross profit | 3,482 | 3,482 | 3,810 - 4,110 | 3,960 |
Operating expenses | (2,417) | (2,219) | (2,710) - (2,910) | (2,810) |
Operating profit | 1,065 | 1,263 | 900 - 1,400 | 1,150 |
2026 Outlook
Net product sales and collaboration revenue consists of EPKINLY net product sales in the US and Japan, and Tivdak ex-US net product sales plus Genmab's share of US gross profits.
Operating expenses and operating profit exclude 2026 and 2025 charges related to: 1) acquisition and integration-related charges of $65 million and $185 million, respectively, and 2) amortization of intangible assets acquired through acquisitions of $45 million and $13 million, respectively.
Revenue
Genmab expects its 2026 revenue to be in the range of $4.1 - 4.4 billion, compared to $3.7 billion in 2025.
Genmab's projected revenue growth for 2026 is driven by higher royalties, net product sales and collaboration revenue. Royalty growth relates mainly to DARZALEX and Kesimpta net sales growth. Net product sales and collaboration revenue growth is driven by strong performance for both EPKINLY and Tivdak. Net product sales and collaboration revenue consists of EPKINLY net product sales in the US and Japan, and Tivdak ex-US net product sales plus Genmab's share of US gross profits.
Genmab's projected revenue for 2026 primarily consists of DARZALEX royalties of approximately
$2.7 billion at the midpoint. Such royalties are based on estimated DARZALEX 2026 net sales of
$15.6 - 16.4 billion compared to actual net sales in 2025 of $14.3 billion. DARZALEX royalties are partly offset by Genmab's share of J&J's royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with SC net sales as well as royalty reduction in countries and territories where there is no Genmab patent coverage.
The remainder of Genmab's revenue consists primarily of royalties from Kesimpta, TEPEZZA, RYBREVANT, TECVAYLI, TALVEY and TEPKINLY,
net product sales and collaboration revenue from EPKINLY and Tivdak, reimbursement revenue and milestones.
Operating ExpensesGenmab anticipates its 2026 operating expenses to be in the range of $2.7 - 2.9 billion, compared
to $2.2 billion in 2025. The increase in operating expenses is primarily related to investments in late-stage programs and launch readiness in key markets.
Operating ProfitGenmab expects its 2026 operating profit to be in the range of $0.9 - 1.4 billion, compared to
$1.3 billion.
Outlook: Risks and AssumptionsIn addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to: the achievement of certain milestones associated with Genmab's collaboration agreements; the timing and variation of development activities (including activities carried out by Genmab's collaboration partners) and related income and costs; DARZALEX, DARZALEX FASPRO, Kesimpta, TEPEZZA, RYBREVANT, TECVAYLI, TALVEY and
TEPKINLY net sales and royalties paid to Genmab; changing rates of inflation; and currency exchange rates (the 2026 guidance assumes a USD/DKK exchange rate of 6.2). The financial guidance assumes that no significant new agreements are entered into during 2026 that could materially affect the results.
The factors discussed above, as well as other factors that are currently unforeseeable, may result in further material adverse impacts on Genmab's business and financial performance, including unfavorable impacts on the sales of Tivdak and EPKINLY/TEPKINLY, and on the net sales of DARZALEX, Kesimpta, TEPEZZA, RYBREVANT,
TECVAYLI, and TALVEY by Genmab's collaboration partners and on Genmab's royalties, collaboration revenue and milestone revenue therefrom.
Who We Are
Our Core Values
In our quest to turn science into medicine, we use these guideposts to transform the future of cancer treatment:
Passion for innovation
Determination - being the best at what we do
Integrity - we do the right thing
We work as one team and respect each other
Our Key Accomplishments
Each of our achievements stands as evidence of our unyielding determination, including:
Two Genmab co-owned medicines on the market: Tivdak with Pfizer and EPKINLY/ TEPKINLY with AbbVie
Six additional medicines that were created by Genmab, or that leverage Genmab's DuoBody technology, are being developed and marketed by global pharmaceutical and biotechnology companies
Late-stage pipeline with high potential: EPKINLY, Rina-S and petosemtamab
Suite of proprietary antibody technologies including bispecifics and antibody-drug conjugate (ADC) platform technologies fueling future innovations
Robust clinical and preclinical pipeline fueling future growth
Over 45 Investigational New Drugs (IND) filed by Genmab and/or partners, based on Genmab's innovations and technology, since 1999
Industry-leading team with antibody know-how, and expertise in R&D and commercial fields
Partnerships with industry leaders and innovators across the innovation ecosystem of pharma, biotech and academia
Partnership with ChatGPT to launch "AI Everywhere," providing ChatGPT access to our teams
Solid financial foundation enabling our evolution to a fully integrated biotech
Building and expanding our capabilities with more than 3,000 team members across our international locations
Genmab's Growing Organization and Presence
Utrecht, The Netherlands
Discovery and Antibody Research
Translational and Quantitative Sciences
Development Operation
Princeton, US
Translational and Quantitative Sciences
Clinical development
Development Operations
U.S. Market Operations
Cambridge, US
Late-stage clinical development
Enabling functions
Copenhagen, Denmark
Headquarters
Chemistry, Manufacturing and Controls (CMC) Operations
Development Operations
Quality Control (QC) Laboratory
European Union (EU) Market Offices
Munich
Paris
London
Suzhou and Shanghai, China
Early-stage R&D
CMC Operations
Tokyo, Japan
Development Operations
Japan Market Operations
Business Model
At Genmab, we have built a profitable and successful biotech that creates value for our stakeholders.
Building a Fully Integrated Biotech Innovation Powerhouse
Team Translational and precision medicine, dataOur Strengths and Differentiators
World-class antibody biology knowledge
and insight into disease targets
Discovery and development engine
with proprietary technologies that allow us to build a differentiated pipeline
In-house expertise with a solid track record of building successful strategic partnerships
Pipeline of potential best-in-class and/or first-in-class therapies
Experienced, diverse leadership team
Business StrategyDeeply driven
One Genmab team rooted in science and inspired by patients
ResearchTrack record of success and investing for tomorrow
DevelopmentScaled up capabilities to expand from early- to late-stage development
science and artificial intelligence (AI)Key to accelerating development and ensuring the right therapies get to the right patients
Technical Operations and CommercializationCapabilities in place to support commercialized medicines
Build a profitable and successful biotech
Maintain a flexible and capital-efficient model
Maximize relationships with partners
Retain ownership of select products
Focus on core competence
Identify the best disease targets
Strong financialsGrowing revenues,
Enabling functions: Supporting growth and managing risk
CollaborationReaches across the innovation ecosystem
Develop unique first-in-class or best-in-class antibodies
Develop next-generation technologies
Turn science into medicine
Create differentiated antibody therapeutics with significant commercial potential
strategic prioritization and
focused investments
of pharma, biotech and
academia, and drives our business forward
Value Chain
Genmab's value chain encompasses the full journey from discovery to global
commercialization of innovative antibody-based therapies. Each stage is designed to drive scientific excellence, ensure product quality, and deliver value to patients, partners, and shareholders.
Research & Development
Our value chain begins with research and discovery, where disease-related targets-primarily in oncology-are identified and proprietary antibody technologies, including DuoBody, HexaBody®, and ADC platforms, are applied to design and optimize novel antibody candidates. These candidates progress to preclinical development, where they are rigorously evaluated for safety, efficacy, and therapeutic potential prior to advancement
into human studies. Clinical development then assesses safety, dosage, and efficacy in
patients and achieve Proof of Concept. Where appropriate, we engage strategic partners to co-develop and co-fund clinical programs, enabling risk sharing across the value chain.
Technical Operations
In manufacturing, Genmab focuses on developing scalable efficient, and sustainable production processes. While we partner with contract manufacturing organizations (CMOs) for manufacturing and production, we maintain strict oversight and quality control to ensure product consistency and compliance with global standards.
Commercialization
Genmab pursues regulatory approval with authorities such as the European Medicines Agency (EMA), FDA, and the Ministry of Health, Labor
and Welfare (MHLW), paving the way for product launch.
Our commercialization activities include market access strategies, engagement with payors and healthcare professionals, and distribution through our own network or in collaboration with partners.
Continuous pharmacovigilance ensures the ongoing safety and effectiveness of our marketed therapies.
Partnerships and Alliances
Partnerships and alliances are integral to our value chain. Through licensing of our proprietary technologies, co-development arrangements, and strategic collaborations. Genmab expands
its innovative ecosystem, advances its pipeline, and generates sustainable revenue through upfront payments, milestones, and royalties.
Refer to section SBM-2 in the sustainability statements for details of key stakeholders including a mapping to Genmab's value chain.
Refer to the Sustainability Statements within this Annual Report for material topics identified as part of Genmab's Double Materiality Assessment (DMA). The visual maps the material topics to Genmab's value chain.
Refer to the Who We Are section for Genmab's presence.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 14
Research and Development Capabilities
Inspired by Nature
At Genmab, we are inspired by nature and understand how antibodies work. We are deeply knowledgeable about
antibody biology and our scientists harness this expertise to create and develop differentiated investigational antibody medicines. We utilize a sophisticated and highly automated process to efficiently generate, select, produce, and evaluate antibody-based products. Our teams have established a fully integrated R&D enterprise and streamlined process to coordinate the activities of antibody product discovery, preclinical testing, manufacturing, clinical trial design and execution, and regulatory submissions across Genmab's international operations. We have expanded our scientific focus to use data science and AI to aid in the discovery of new targets and biomarkers and bolster our in-depth precision medicine and translational laboratory capabilities. Through our expertise in antibody drug development, we pioneer technologies that allow us to create differentiated and potentially first-in-class or best-in-class investigational medicines with the potential to improve patients' lives. Our antibody expertise has enabled us to create our cutting-edge technology platforms: DuoBody, HexaBody, DuoHexaBody® and HexElect®. With our acquisition of ProfoundBio we gained novel ADC technology platforms.
We gained additional proprietary technology platforms as part of
our acquisition of Merus. Additional information about our technologies is available on Genmab's website, genmab.com/ antibody-science/antibody-technology-platforms.
Research and Development Capabilities
Sustainable and State-of-the-Art Facilities
The NetherlandsIn the Netherlands, Genmab operates from two adjoined state-of-the-art buildings at the Utrecht Science Park-the Genmab research and Development Center (GRDC) and the Accelerator. Mainly discovery, translational and CMC research is conducted at these facilities, which house state-of-the-art laboratories,
including a new chemistry lab that opened at the GRDC in 2024. The GRDC was one of the first Building Research Establishment Environmental Assessment Method (BREEAM) Excellent laboratory buildings in the Netherlands. The Accelerator, a multi-tenant ultra-modern R&D facility, was opened in 2023, enabling our continued R&D growth trajectory. These two spaces are located in close proximity to premier universities, academic medical centers and other life science companies. They accommodate modern auditoriums, and innovative brainstorming and meeting rooms. They provide a bright, open, and collaborative atmosphere and enable the Genmab team to continue to innovate and create new ways to help patients.
DenmarkDenmark, with its rich history of scientific achievement and innovation, has been home to Genmab's headquarters for more than 25 years. We are surrounded by a vibrant ecosystem of talent, with multiple biotech and pharma peers, academia and research centers, knowledge, and resources. Genmab opened our new headquarters in Valby, Denmark in 2023, a space designed specifically for Genmab. In addition, Genmab introduced our own Good Manufacturing Practice (GMP) QC laboratory in 2023. The new space insources certain business-critical processes and capabilities for our early clinical development. With our growing pipeline and commercial ambitions, we are taking control of processes, prioritization, people, and timing and taking another tremendous step toward becoming an end-to-end biotech innovation powerhouse.
United StatesGenmab opened a new US facility in 2020, which was subsequently expanded in 2025. This space, modeled on the open and collaborative spirit of the R&D labs and offices in Utrecht, includes both offices and laboratories. The U.S. translational and quantitative laboratories allow Genmab to expand our preclinical and clinical drug development expertise and are part of the strategic growth of the Company. As with our Utrecht facilities, our U.S. office and laboratories were designed and built with sustainability in mind and meet the requirements for Leadership in Energy and Environmental Design (LEED) Gold certification for sustainable design features.
JapanGenmab's Japan office is located in Roppongi, an international business district in the center of Tokyo. It offers an open and collaborative environment that fosters Genmab's culture
of innovation and teamwork.
ChinaAs part of our acquisition of ProfoundBio, Genmab expanded our presence with state-of-the-art ADC research and CMC capabilities in Suzhou, China.
EuropeIn 2025 and 2026 we opened Market offices in Munich, Germany, London, UK and Paris, France.
As Genmab continues to grow our geographical footprint, we will endeavor to do so with minimal impact to the environment and with a focus on sustainable practices.
Expanding the Reach of Our Medicines
A fully integrated biotech delivering for patients around the world
This year, we accelerated our transformation into a fully integrated biotechnology company-one designed to deliver meaningful, antibody-based medicines to patients at scale. We reached more patients than ever before, reflecting the growing global impact of our science and our ability to reliably bring innovation to the people who
need it most.
Our medicines have achieved leading positions worldwide, reaching more than 13,000 patients through 2025. We also celebrated a major milestone with our first independently led launches, and expanded our operations into France, Germany, and the UK, supported by extra[not]ordinary® talent and capabilities that position us to extend our reach and impact even further in the years ahead.
Driving Meaningful Progress in Lymphoma
EPKINLY (epcoritamab) continued to redefine what's possible for patients as the only bispecific antibody with indications in both FL and DLBCL in the U.S., Europe, and Japan.
In February, EPKINLY became the first bispecific therapy approved in Japan for 3L+ relapsed/ refractory FL, marking the medicine's second indication in the country and reinforcing its growing global presence.
In November, EPKINLY in combination with R2 became the first bispecific-based therapy to enter earlier lines of FL treatment with FDA approval in relapsed/refractory FL. This approval has the potential to broaden access to this bispecific-based treatment across sites of care, including community settings closer to where patients live. A submission for this indication was also filed in Japan in November.
Building on its established role as a later-line monotherapy option, this progress underscores EPKINLY's potential to become a core therapy for B-cell malignancies, demonstrating meaningful benefit both as a single agent and in combination, as well as in earlier stages of disease.
With regulatory approvals now in more than 65 countries and ongoing Phase 3 studies across multiple lymphoma histologies and lines of therapy, EPKINLY is well-positioned to continue expanding its reach to more patients around the world.
Working to Improve Outcomes in Gynecologic Cancers
Cervical Cancer Support: CeMe™
The CeMe campaign in the U.S., created with Pfizer, creates connection and community for those affected by cervical cancer.
"To be diagnosed with cervical cancer… knocked the wind out of me," said Karen. "Sharing your story… lets people know that there are other people out there that can support you."
youtube.com/cemestories
Follicular Lymphoma
Follicular lymphoma is the second most common non-Hodgkin lymphoma and is considered incurable, underscoring the need for new treatments.
Genmab's commitment to patients with gynecologic cancers is rooted in a simple belief: people facing these diseases deserve better options. We are working to deliver on that promise by expanding access to Tivdak (tisotumab vedotin) today, while advancing a pipeline of potential therapies for tomorrow.
Cervical cancer remains the fourth leading cause of cancer-related death among women worldwide.
The need for improved treatments is particularly urgent in Japan, where both incidence and mortality have risen in recent years, especially among women under 50. In Europe, despite advances in prevention and early detection, there remains a significant unmet need for effective treatments for advanced-stage disease.
Approved in the U.S. in 2021, Tivdak transformed the treatment landscape for advanced cervical cancer, offering a new standard of care where options were limited. In 2025, Tivdak achieved additional regulatory approvals in the EU, Japan, and the UK, marking the start of a new chapter in its global reach.
Tivdak also continues to catalyze our evolution into a fully integrated, end-to-end company. It was the first medicine we launched in partnership and continues to set the course for how we bring medicines to patients. The launch of Tivdak in Japan, the first executed independently by Genmab, represents a major step toward our ambition to bring our own medicines to market.
Expanding the Reach of Our Medicines
In September, Tivdak became available in Germany, marking our first commercial launch in Europe and establishing the foundation for our expanding regional footprint, including new operations in France, Germany, and the
United Kingdom.
With increasing global access to Tivdak and strong patient uptake, Genmab is building a robust foundation for broader impact across gynecologic cancers as we continue to advance our innovative pipeline with investigational assets like Rina-S that could broaden our reach to areas including ovarian and endometrial cancers.
Ensuring Rapid and Sustainable Access to Our Medicines
We are focused on our pursuit to turn innovative science into medicines that create value and provide meaningful impact to patients and health systems.
Tivdak
Tivdak is the first and only ADC approved in the US, Europe, and Japan for the treatment of recurrent or metastatic cervical cancer after prior therapy and is the only ADC with demonstrated overall survival data in this setting compared to chemotherapy.
Ultimately, we positively impact the lives of people with cancer when our science becomes medicine, our medicine creates value, and the value of our medicine is realized by patients who can benefit. Patient access and affordability are key components of this.
We aim to ensure patients have timely access to our medicines, regardless of their socioeconomic or insurance status. Our pricing approach balances this commitment to access with the value of our innovations and our ability to invest in the breakthrough science of the future.
Together with our partners, we work with local country regulatory and payer authorities in the U.S., Japan, and throughout Europe to facilitate registration and reimbursement to help enable patient access to our medicines around the
world. At the same time, we fundamentally
believe that global, sustainable access requires fair contribution among developed nations towards innovation costs. For the global innovation ecosystem to thrive and for patients to benefit, value and pricing mechanisms must recognize the different healthcare infrastructures and economic contexts of individual markets.
We understand that true patient impact happens when our medicines reach the patients who need them. In the U.S., MyNavCare Patient Support® by Genmab was created to offer support services to patients prescribed Genmab medicines to help them navigate each step of their unique
Elevating Patient Voices
Our Patient Advisory Council gives patients a seat at the table, ensuring their insights and experiences will help guide our work, from trial design to how we support and deliver our medicines.
"Serving on Genmab's Patient Advisory Council means the patient voice will have a direct influence on what comes next," said Jim Zervanos. "It's empowering and inspiring to know my experience will help shape decisions that can benefit others like me."
treatment journey.
Our Approach to Value, Access, and Pricing
Value: The value of our medicines is driven by our innovative science.
Access: Patient impact happens when our medicines reach the people who need them and help them live better.
Pricing: The price of our medicines reflects the innovation behind our science, its impact on patients, and our commitment to bringing that science
to patients.
Antibody Discovery and Development
We are experts in antibody discovery and development. Our appreciation for, and understanding of, the power of the human immune system gives us a unique perspective on how to respond to the constant challenges of oncology drug development. We entered a new chapter in Genmab's evolution with the commercialization and launch of our first medicine, Tivdak, co-owned with Pfizer,
in 2021, and we successfully launched our second medicine, EPKINLY/TEPKINLY, in 2023 under our collaboration with AbbVie. As part of our shift into a fully integrated biotech we also have wholly owned programs in Phase 3 development.
ADC/Immunocytokine Designer Polyclonals/
Bispecifics
Half-Life Extended/Inert/ Fc-Enhanced/Isotypes
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 19
Products and Technologies
Pipeline
At the end of 2025, Genmab's proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of five antibody products in active clinical development. Our approved medicines are EPKINLY/TEPKINLY, which Genmab is co-developing and
co-commercializing in the US and Japan in collaboration with AbbVie and Tivdak, which Genmab is co-developing globally and co-promoting in the US in collaboration with Pfizer and exclusively by Genmab outside of the US and China. In addition to our own pipeline, there are multiple investigational medicines in development by global pharmaceutical and biotechnology companies and six approved medicines powered by Genmab's technology and innovations. BIZENGRI® (zenocutuzumab-zbco) was also added to our portfolio of royalty medicines as part of our acquisition of Merus. Beyond the investigational medicines in active clinical development, our pipeline includes multiple promising preclinical programs. An overview of the development status of our approved medicines and our late-stage investigational medicines is provided in the following sections. Detailed descriptions of dosing and efficacy and safety data from certain clinical trials have been disclosed in company announcements and media releases published via the Nasdaq Copenhagen stock exchange and may also be found in Genmab's filings with the U.S. Securities and Exchange Commission (SEC). Additional information is available on Genmab's website, genmab.com. The information accessible through our website is not part of and is not incorporated by reference herein.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 20
Products and Technologies
Genmab's Proprietary1 Products
Approved Medicines
Approved Product Target Developed By Disease Indication(s)2
EPKINLY
(epcoritamab-bysp, epcoritamab) TEPKINLY
(epcoritamab)
Tivdak
(tisotumab vedotin-tftv, tisotumab vedotin)
CD3xCD20 Co-development Genmab/AbbVie
TF Co-development Genmab/ Pfizer
Approved in multiple territories including the US and Europe for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy and in Japan for adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
Approved in multiple territories including the US, Europe and Japan for adult patients with relapsed or refractory FL after two or more lines of systemic therapy
Approved in multiple territories including the US in combination with R2 for the treatment of adult patients with relapsed or refractory FL, following at least one prior systemic therapy
Approved in territories including the US, Europe and Japan for adult patients with recurrent/metastatic cervical cancer with disease progression on or after chemotherapy
Approved and investigational medicines where Genmab has ≥50% ownership, in co-development with partners as indicated.
Refer to local country prescribing information for precise indication and safety information.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 21
Products and Technologies
Pipeline in Active Clinical Development, Including Further Development for Approved Medicines
Product Developed By Target(s) Technology Disease Indications Most Advanced Development Phase
Preclinical 1 2 3
Epcoritamab | Co-development | CD3, CD20 | DuoBody | Relapsed/refractory DLBCL | |||||
Genmab/AbbVie | Relapsed/refractory FL | ||||||||
First line DLBCL | |||||||||
First line FL | |||||||||
Non-Hodgkin lymphoma (NHL) | |||||||||
Relapsed/refractory chronic lymphocytic leukemia (CLL) & Richter's Syndrome | |||||||||
Aggressive mature B-cell neoplasms in pediatric patients | |||||||||
Rinatabart | Genmab | Folate receptor alpha | ADC | PROC | |||||
Sesutecan | (FRα) | ||||||||
Endometrial cancer | |||||||||
(Rina-S, | PSOC | ||||||||
GEN1184) | |||||||||
NSCLC | |||||||||
Solid tumors | |||||||||
Petosemtamab | Genmab | Epidermal growth factor receptor (EGFR), leucine-rich repeat-containing G-protein coupled receptor 5 ( LGR5) | Biclonics® | Recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) | |||||
Advanced solid tumors including metastatic colorectal cancer (mCRC) | |||||||||
First line NSCLC with pembrolizumab | |||||||||
GEN1059 | Co-development | Epithelial cell adhesion | DuoBody | Solid tumors | |||||
(BNT314) | Genmab/BioNTech | molecule (EpCAM), 4-1BB | |||||||
mCRC, in combination with pumitamig/chemo | |||||||||
SE (BioNTech) | |||||||||
GEN1057 | Genmab | Fibroblast activation protein alpha (FAPα), death receptor 4 (DR4) | DuoBody | Malignant solid tumors | |||||
In the fourth quarter of 2025, further development of acasunlimab was discontinued as part of Genmab's strategic focus on the most value-creating opportunities in its late-stage portfolio and following a thorough assessment of the evolving competitive landscape.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 22
Products and Technologies
Royalty Medicines Portfolio1
Approved Medicines
Approved Product Discovered and/or Developed/Marketed By Disease Indication(s)2
DARZALEX
hyaluronidase-fihj) | Light-chain (AL) Amyloidosis | |
Kesimpta | Novartis (Royalties to Genmab on global net sales) | Relapsing multiple sclerosis (RMS) |
(ofatumumab) | ||
TEPEZZA (teprotumumab-trbw) | Amgen (under sublicense from Roche, royalties to Genmab on global net sales) | Thyroid eye disease (TED) |
RYBREVANT | J&J (Royalties to Genmab on global net sales) | Advanced NSCLC with certain EGFR mutations |
(amivantamab/amivantamab-vmjw)/RYBREVANT FASPROTM (amivantamab and hyaluronidase-lpuj) | ||
TECVAYLI | J&J (Royalties to Genmab on global net sales) | Relapsed and refractory multiple myeloma |
(teclistamab/teclistamab-cqyv) | ||
TALVEY | J&J (Royalties to Genmab on global net sales) | Relapsed and refractory multiple myeloma |
(talquetamab/talquetamab-tgvs) | ||
BIZENGRI | Partner Therapeutics, Inc. (part of Genmab's acquisition of Merus, | Pancreatic adenocarcinoma and NSCLC that are advanced, |
(zenocutuzumab-zbco) | royalties to Genmab on U.S. net sales) | unresectable or metastatic and harbor NRG1 gene fusions |
(daratumumab)/DARZALEX FASPRO (daratumumab and
J&J (Royalties to Genmab on global net sales) Multiple myeloma
Approved and investigational medicines under development, and where relevant, commercialized by a company other than Genmab for which we receive royalties.
See local prescribing information for precise indication and safety information.
Pipeline, Including Further Development for Approved Medicines, ≥Phase 2 Development
Product Technology Discovered and/or Developed By Disease Indications Most Advanced Development Phase
Preclinical 1 2 3
Daratumumab | UltiMAb1 | J&J | Multiple myeloma | |||||
AL Amyloidosis | ||||||||
Teprotumumab | UltiMAb | Amgen | TED | |||||
Amivantamab | DuoBody | J&J | NSCLC | |||||
Advanced or mCRC | ||||||||
Recurrent/metastatic head and neck cancer | ||||||||
Teclistamab | DuoBody | J&J | Multiple myeloma | |||||
Talquetamab | DuoBody | J&J | Multiple myeloma | |||||
Mim8 (denecimig) | DuoBody | Novo Nordisk | Hemophilia A | |||||
Amlenetug (Lu AF82422) | UltiMAb | H. Lundbeck A/S (Lundbeck) | Multiple system atrophy | |||||
1. UltiMab transgenic mouse technology licensed from Medarex, Inc. (Medarex), a wholly owned subsidiary of Bristol-Myers Squibb.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 23
Genmab's Late-stage Proprietary Pipeline
Approved and Phase 3 Programs where Genmab has ≥50% ownership.
EPKINLY/TEPKINLY
(epcoritamab)
The only bispecific antibody approved to treat multiple B-cell malignancies in the US, Europe and Japan
Epcoritamab (approved as EPKINLY and TEPKINLY) has
received regulatory approvals in multiple territories including in the US and Europe for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy, and in Japan for adult patients with certain types of relapsed or refractory LBCL after two or more lines of systemic therapy
EPKINLY/TEPKINLY has also been approved in multiple territories including the US, Japan and Europe for the treatment of adults with relapsed or refractory FL after two or more lines of systemic therapy
In 2025 EPKINLY plus R2 became the first bispecific antibody combination regimen available in the US as a treatment option for patients with relapsed/refractory FL
More than 40 clinical trials are ongoing across different treatment settings, lines of therapy and in combination regimens across histologies, including five
Phase 3 trials
Two BTDs granted by the FDA for relapsed/refractory FL: as monotherapy after two or more therapies and in combination with R2 following at least one prior systemic therapy
SC bispecific antibody targeting CD3 and CD20, created using Genmab's DuoBody technology platform
Co-developed and
co-commercialized in collaboration with AbbVie
Epcoritamab is a proprietary bispecific antibody created using Genmab's DuoBody technology platform. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically validated target on malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab.
Epcoritamab is marketed as EPKINLY in the US, Japan, and other regions, and as TEPKINLY in Europe and other regions.
See local prescribing information for specific indications and safety information. In 2020, Genmab entered into a collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab. The companies share commercialization responsibilities in the US and Japan, with AbbVie responsible for further global commercialization.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 24
Genmab's Late-stage Proprietary Pipeline
Genmab records sales in the US and Japan and receives tiered royalties between 22% and 26% on remaining global sales outside of these territories, subject to certain royalty reductions. The companies have a broad clinical development program for epcoritamab including five ongoing Phase 3 trials and additional trials in planning. Please refer to Note 5.6 of the financial statements for further details regarding the epcoritamab collaboration with AbbVie.
Please consult the U.S. Prescribing Information for EPKINLY and the European Summary of Product Characteristics forTEPKINLY for the labeled indication and safety information.
EPKINLY/TEPKINLY (CON'T)Fourth Quarter Updates December: Epcoritamab-bysp in combination with R2 was added to the National Comprehensive Cancer Network® (NCCN®)
Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for "B-Cell lymphomas" (Version 1.2026) for second-line FL therapy as a Category 1, preferred regimen, the only bispecific antibody listed in this setting.
November: FDA approval of EPKINLY in combination with R2 for the treatment of adult patients with relapsed or refractory FL, following at least one prior systemic therapy.
The approval was based on data from the first interim analysis of the Phase 3 EPCORE FL-1 (NCT05409066) trial. With the results from this study the FDA also converted the June 2024 accelerated approval of EPKINLY monotherapy for the treatment of relapsed/refractory FL following two or more lines of systemic therapy into a full approval.
October: Epcoritamab-bysp monotherapy
was added to the NCCN Guidelines for "Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma" (Version 1.2026) for Richter's transformation as a Category 2A, preferred regimen.
Key Updates From First Quarter To Third QuarterAugust: In a second pre-planned interim analysis the Phase 3 EPCORE FL-1 trial met its dual primary endpoints of ORR and PFS. The safety profile of epcoritamab in combination with R2 was consistent with the known safety profiles of the individual regimens and as presented in the U.S. prescribing information for epcoritamab. These results will serve as the basis for global regulatory submissions. The data was selected for an oral presentation at the 67th Annual Meeting and Exposition of ASH in December 2025.
September: Updated results from the Phase 2 EPCORE NHL-6 trial (NCT05451810) were
presented as a poster at the 13th Society of Hematologic Oncology Annual Meeting. These results demonstrated the feasibility of treating and monitoring patients in an outpatient setting
following the first dose of epcoritamab and showed that the incidence and severity of adverse events associated with epcoritamab were consistent with previous epcoritamab studies in patients with relapsed/refractory DLBCL.
February: Epcoritamab-bysp in combination with gemcitabine and oxaliplatin (GemOx) was added to the NCCN Clinical Practice Guidelines in
Oncology for "B-cell Lymphomas" (Version 2.2025) for second-line patients with DLBCL who are ineligible for transplant as a Category 2A, preferred regimen.
January: The Japan MHLW approved EPKINLY (epcoritamab) for the treatment of patients with relapsed or refractory FL who have received two or more lines of therapy.
About Diffuse Large B-cell LymphomaDLBCL is the most common type of NHL worldwide, accounting for approximately 25-30% of all NHL cases.1 In the US there are approximately 25,000 new cases of DLBCL diagnosed each year.2
DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.3,4 DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.5,6
NHL Subtypes. Leukemia & Lymphoma Society. lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes. Accessed December 2025.
Diffuse large B-cell lymphoma (DLBCL) research. Blood Cancer United. bloodcancerunited.org/research/blood-cancer-research-development-progress/lymphoma/ diffuse-large-b-cell-lymphoma-dlbcl.
Accessed December 2025.
Sehn LH, Salles G. N Engl J Med. 2021;384:842-858.
Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63.
Sehn LH, Salles G. N Engl J Med. 2021;384:842-858.
Crump M, Neelapu SS, Farooq U, et al. Blood. 2017;130(16):1800-1808.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 25
Genmab's Late-stage Proprietary Pipeline
EPKINLY/TEPKINLY (CON'T)Ongoing Clinical Trials
B-NHL Type Stage Development Phase
DLBCL | Relapsed/Refractory | EPCORE DLBCL-1 | |||
Front-line + R-CHOP | EPCORE DLBCL-2 | ||||
Relapsed/Refractory + lenalidomide, ASCT ineligible | EPCORE DLBCL-4 | ||||
Front-line +/- lenalidomide | EPCORE DLBCL-3 | ||||
FL | Relapsed/Refractory (Combo) | EPCORE FL-1 | |||
Front-line +R2 | EPCORE FL-2 | ||||
DLBCL & FL Outpatient | EPCORE NHL-6 | ||||
B-NHL | Relapsed/Progressive/Refractory | EPCORE NHL-1 | |||
Relapsed/Progressive/Refractory (Japan) | EPCORE NHL-3 | ||||
Relapsed/Refractory Pediatric | EPCORE Peds-1 | ||||
Previously Untreated/Relapsed/Refractory (Combo) | EPCORE NHL-2 | ||||
Previously Untreated/Relapsed/Refractory (China) | EPCORE NHL-4 | ||||
Previously Untreated/Relapsed/Refractory (Combo) | EPCORE NHL-5 | ||||
CLL/Richter's Syndrome Relapsed/Refractory | EPCORE CLL-1 | ||||
Preclinical 1 2 3
R-CHOP = rituximab-cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone; ASCT = autologous stem cell transplant
~15,000
FL accounts for
20%-30%
people develop FL
About Follicular LymphomaFL is typically an indolent (or slow-growing) form of NHL that arises from B-lymphocytes and is the second most common form of NHL accounting for 20 - 30% of all cases.1 About 15,000 people develop FL each year in the US2 and it is considered incurable with current standard of care therapies.3 Patients often relapse and, with each relapse the remission and time to next treatment is shorter.4 Over time, transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.5
Lymphoma Research Foundation official website. lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 4, 2025.
Leukemia & Lymphoma Society. lls.org/ research/follicular-lymphoma-fl. Accessed November 4, 2025.
Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/ refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.
Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/
JCO.2008.16.0283. Epub 2008 Oct 6.
PMID: 18838711.
Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.
of all NHL cases each year in the US
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 26
Genmab's Late-stage Proprietary Pipeline
Tivdak
(tisotumab vedotin-tftv)
First and Only ADC for Recurrent or Metastatic Cervical Cancer in the US, Europe and Japan
An ADC directed to tissue factor (TF), a protein highly prevalent on solid tumors, including cervical cancer, which is associated with poor prognosis
Tisotumab vedotin, approved as Tivdak, is the first and only ADC approved in the US, Europe and Japan for the treatment of recurrent or metastatic cervical cancer with disease progression on or after prior therapy and is the only ADC with demonstrated overall survival data in this setting compared to chemotherapy
Co-developed globally and co-promoted in the US in collaboration with Pfizer, exclusively by Genmab outside of the US and China
Tisotumab vedotin is an ADC composed of Genmab's human monoclonal antibody directed to TF and Pfizer's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl
auristatin E (MMAE) to the antibody. Genmab used technology licensed from Medarex to generate the TF antibody forming part of tisotumab vedotin.
Tisotumab vedotin, marketed as Tivdak, is the first and only ADC approved for the treatment of adult patients with recurrent or metastatic cervical cancer after prior therapy in territories including the US,
Europe and Japan. Tisotumab vedotin is being co-developed by Genmab and Pfizer. Under a joint commercialization agreement, Genmab is co-promoting Tivdak in the US and is leading commercial operational activities in Japan, Europe and all other regions globally, excluding the United States and China. Pfizer is leading commercial operational activities in the US and
will lead commercial operational activities in China once approved in connection with the sublicense of its rights to develop and commercialize tisotumab vedotin in China to Zai Lab. Genmab records sales for Europe, Japan and rest of world markets (excluding the US and China), and provides royalties in the low teens to Pfizer on net sales.
The companies have joint decision-making on the worldwide development and commercialization strategy for Tivdak.
Please refer to Note 5.6 of the financial statements for further details regarding the tisotumab vedotin collaboration with Pfizer.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for Tivdak for thelabeled indication and safety information, including the boxed warning.
Key Updates From First Quarter To Third QuarterSeptember: Tivdak became available for prescribing in Germany. This is the first European country where this medicine is commercially available following approval by the European Commission (EC) in March 2025.
March: The EC granted marketing authorization for Tivdak (tisotumab vedotin) as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. Tivdak is the first and only ADC to
be granted EU marketing authorization for people living with recurrent or metastatic cervical cancer.
March: The Japan MHLW approved Tivdak (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. Tivdak is the first and only ADC to be approved for people living with cervical
cancer in Japan.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 27
Genmab's Late-stage Proprietary Pipeline
Tivdak (CON'T)January: Genmab and Pfizer agreed to amend the License and Collaboration Agreement and the Joint Commercialization Agreement for Tivdak, assigning Genmab sole responsibility for the development and commercialization
of Tivdak for second line plus recurrent or metastatic cervical cancer in Europe and all other regions globally, excluding the US and China.
About Cervical CancerCervical cancer remains a disease with high unmet need despite advances in effective vaccination and screening practices to prevent and diagnose pre-/early-stage cancers for curative treatment. Recurrent and/or metastatic cervical cancer is a particularly devastating and mostly incurable disease; up to 15% of adults with cervical cancer present with metastatic disease at diagnosis1,2 and, for adults diagnosed at earlier stages who receive treatment, up to 61%3 will experience disease recurrence.
Cervical cancer is the fourth most common cause of cancer death among women globally4.
National Cancer Institute. SEER Cancer Stat Facts: Cervical Cancer. 2023. seer.cancer.gov/statfacts/ html/cervix.html. Accessed November 4, 2025.
McLachlan J, Boussios S, Okines A, et al. The impact of systemic therapy beyond first-line treatment for advanced cervical cancer. Clin Oncol (R Coll Radiol). 2017;29(3):153-60
Pfaendler KS, Tewari KS. Changing paradigms in the systemic treatment of advanced cervical cancer. Am J Obstet Gynecol. 2016;214(1):22-30
Wu, Jie, and Qianyun Jin. "Global Burden of Cervical Cancer: Current Estimates, Temporal Trend and Future Projections Based on the Globocan 2022." Journal of the National Cancer Center, 23 Jan. 2025, sciencedirect.com/science/ article/pii/S2667005425000134.
4th
most common cause of cancer death among women globally
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 28
Genmab's Late-stage Proprietary Pipeline
Rinatabart Sesutecan
(Rina-S, GEN1184)
Folate Receptor Alpha (FRα)-targeted Type I Topoisomerase (TOPO1) inhibitor ADC with FDA Fast Track and Breakthrough Therapy Designations
FRα-targeted TOPO1 ADC being evaluated for potential treatment of FRα-expressing cancers
FDA granted Fast Track Designation (FTD) for FRα-expressing high-grade serous or endometrioid PROC and
BTD for recurrent or progressive endometrial cancer
Potentially registrational Phase 2 clinical trials (expansion
arms of RAINFOLTM-01,
NCT05579366) in PROC
and second line plus endometrial cancer are ongoing
Three Phase 3 clinical trials recruiting; PROC, PSOC, endometrial cancer as well as a Phase 2 signal seeking trial in NSCLC
Rina-S is a novel FRα-targeted TOPO1 ADC being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. Dose escalation data suggests that Rina-S has robust single agent activity in various cancers across a broad range of FRα expression levels. In January 2024, Rina-S was granted FTD by the FDA for the treatment of FRα-expressing high-grade serous
or endometrioid PROC. In August 2025 the FDA granted BTD for recurrent or progressive endometrial cancer. Three Phase 3 trials are
currently recruiting: RAINFOL-02 (NCT06619236) in PROC, RAINFOL-03 (NCT07166094) in second
line plus endometrial cancer and RAINFOL-04 (NCT07225270) in second line PSOC. In addition, a Phase 2 trial (RAINFOL-05, NCT07288177) has been initiated.
Fourth Quarter UpdatesDecember: The Phase 2 RAINFOL-05 was initiated to evaluate Rina-S in NSCLC.
November: The Phase 3 RAINFOL-04 trial was initiated to evaluate Rina-S with or without bevacizumab, versus bevacizumab or observation as a maintenance treatment after second-line platinum-based doublet
chemotherapy in patients with recurrent PSOC.
October: The Phase 3 RAINFOL-03 trial was initiated to evaluate Rina-S versus investigator's choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and PD(L)-1 therapy.
Key Updates From First Quarter to Third QuarterAugust: The FDA granted BTD to Rina-S for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
June: The first disclosure of data from the Phase 1/2 RAINFOL-01 trial (NCT05579366,
B2 cohort) in patients with recurrent/advanced endometrial cancer was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated results, consistent with the favorable results presented at ASCO, were subsequently presented at the European Society for Medical Oncology (ESMO) in October.
March: Encouraging updated data from the Phase 1/2 RAINFOL-01 trial
(NCT05579366, B1 cohort) was presented during an oral presentation at the 2025 Society of Gynecologic Oncology Annual Meeting on Women's Cancer®.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 29
Genmab's Late-stage Proprietary Pipeline
Petosemtamab
EGFRxLGR5 bispecific antibody with FTD and Two BTDs from the FDA
EGFRxLGR5 bispecific antibody being evaluated for potential treatment of EGFR-expressing cancers, focusing on HNSCC
FDA granted FTD for r/m HNSCC and BTD for both first line and second line plus r/m HNSCC indications
Potential for accelerated approval in the US, both first line and second/third line r/m HNSCC
Two Phase 3 trials ongoing in first line and second/third line r/m HNSCC, potential topline interim readout of one or both in 2026
Expansion opportunity in locally advanced HNSCC
Petosemtamab was added to Genmab's portfolio with the acquisition of Merus. Petosemtamab is an EGFRxLGR5 bispecific antibody being evaluated for the potential treatment of HNSCC and other solid tumors including mCRC. Petosemtamab has demonstrated a significant clinical benefit in both first line and later line HNSCC settings. The FDA has granted FTD in r/ m HNSCC and BTD for both first line PD-L1 positive and second line plus r/m HNSCC. Two Phase 3 trials are currently recruiting; LiGeR-HN1 (NCT06525220) in first line r/m PD-L1 positive HNSCC and LiGeR-HN2 (NCT06496178)
in second/third line r/m HNSCC. Petosemtamab
is also being evaluated in a Phase 2 study (NCT03526835) of other advanced solid tumors, including mCRC, and a Phase 2 study (NCT07353957) in first line NSCLC. In November 2025, Merus announced that they had entered a global collaboration and license agreement with Halozyme to develop a subcutaneous formulation of petosemtamab.
Management's Review Financial Statement Other Information Genmab 2025 Annual Report 30
Preclinical Programs
Broad preclinical pipeline that includes both partnered products and in-house programs based on our proprietary technologies and/ or antibodies
Multiple new IND applications expected to be submitted over the coming years
Genmab has entered multiple strategic collaborations to support the expansion of our innovative pipeline, including our acquisition of ProfoundBio in 2024 and Merus in 2025
Our preclinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody technology platform, bispecific antibodies created with our DuoBody technology platform and ADCs created with our ADC technology platforms. We are also collaborating
with our partners to generate additional new antibody-based product concepts. A number of the preclinical programs are conducted in cooperation with our collaboration partners.
Fourth Quarter UpdatesNovember: IND submitted for GEN1079
November: IND submitted for GEN1106
Attachments
- Original document
- Permalink
Disclaimer
Genmab A/S published this content on February 17, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on February 17, 2026 at 16:08 UTC.
