UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF FEBRUARY 2023
COMMISSION FILE NUMBER 001-38976
Genmab A/S
(Exact name of Registrant as specified in its charter)
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
+45 70 20 27 28
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ⌧ Form 40-F ◻
This report on Form 6-K shall be deemed to be incorporated by reference in Genmab A/S’s registration statements on Form S-8 (File No. 333-232693) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GENMAB A/S | |
| | |
| BY: | /s/ Anthony Pagano |
| | Name: Anthony Pagano |
| | Title: Executive Vice President & Chief Financial Officer |
DATE: February 22, 2023
EXHIBIT INDEX
Exhibit | Description of Exhibit |
| |
99.1 | |
99.1 (a) | |
101.INS | Inline XBRL Instance Document |
101.SCH | Inline XBRL Taxonomy Extension Schema Document |
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
Exhibit 99.1
GENMAB 2022 ANNUAL REPORT
Table of Contents
Management’s Review | |
2 | |
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3 | |
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6 | |
9 | |
11 | |
13 | |
14 | |
15 | |
Enhancing Commercialization Capabilities to Bring Our Innovations to Patients | 16 |
17 | |
17 | |
Corporate Social Responsibility and Sustainability Commitments | 37 |
Genmab’s Task Force on Climate-related Financial Disclosures | 40 |
44 | |
46 | |
48 | |
58 | |
63 | |
64 | |
66 | |
69 | |
71 | |
74 | |
131 | |
150 | |
151 | |
155 | |
155 | |
157 | |
158 |
Our Reporting Suite
Our Corporate Responsibility, Corporate Governance and Compensation Reports for 2022 can be found on our website, Genmab.com.
GENMAB 2022 ANNUAL REPORT
Our 2030 Vision
By 2030, our KYSO (knock-your-socks-off) antibody medicines are fundamentally transforming the lives of people with cancer and other serious diseases.
Our Core purpose: Supporting our 2030 Vision is our core purpose – our unstoppable team will improve the lives of patients through innovative and differentiated antibody therapeutics.
Chair’s Statement
Dear Shareholder,
At Genmab, we strive to be innovative and forward-thinking in everything we do, not just in our approach to discovering and developing differentiated antibody therapeutics. As a result, in 2022 the unstoppable team at Genmab built on our already solid foundation with progress throughout our business.
COMMITMENT TO SUSTAINABILITY AND THE ENVIRONMENT
Over the past year, we continued our business-driven corporate responsibility strategy with an emphasis on measuring our carbon footprint, setting climate ambitions and targets, and improving our climate-related disclosures. We remained committed to our three previously selected United Nations Sustainable Development Goals (UNSDGs), and added an additional UNSDG, Goal 13: Climate Action.
We are also dedicated to transparency and the continued improvement of our climate disclosures. We have included in our Annual Report our disclosures in accordance with the Task Force on Climate-related Financial Disclosures (TCFD) recommendations. In addition, we have an intention to commit to a climate target to reduce our greenhouse gas (GHG) emissions in line with the Paris Agreement. Because of our focus on sustainability, Genmab scores well on external benchmarking for environmental, social and governance (ESG) and we continually seek ways to improve and remain compliant with existing and new requirements. In 2023, we will continue our commitment to environmental responsibility and sustainability and will look for opportunities to further integrate this commitment into our business. I encourage you to read our 2022 Corporate Responsibility Report for more information.
EXPERIENCED LEADERSHIP
In 2022, we further strengthened our Senior Leadership team with the appointments of Birgitte Stephensen to Chief Legal Officer and Chris Cozic to Chief People Officer. Both leaders have experience in their fields, within and outside of Genmab. Birgitte Stephensen joined Genmab in 2002 and previously served as Genmab’s Senior Vice President, Intellectual Property Rights and Legal. Chris Cozic joined Genmab in 2017 and most recently served as Senior Vice President, Global Human Resources.
We also saw a change to our Board of Directors with the election of Elizabeth O’Farrell at Genmab’s 2022 Annual General Meeting. During her 24-year career at Eli Lilly, Ms. O’Farrell served as CFO of some of the company’s largest businesses, including as Head of Global Finance Operations. She has solid financial
GENMAB 2022 ANNUAL REPORT
experience including strategic, operational and financial decision-making and reporting across the value chain as well as expertise in driving global change initiatives.
On behalf of the Board of Directors, I would like to thank Genmab’s dedicated team members, CEO Jan van de Winkel and the entire global leadership team for their inspiration and extraordinary leadership as well as our shareholders for their continued support.
Sincerely,
Deirdre P. Connelly
Board Chair
Letter from the CEO
Dear Shareholder,
A SUCCESSFUL STRATEGY
When I became CEO of Genmab in 2010 there was an imperative to outline a new strategy – one that would reposition the company to become financially sustainable and allow us to invest in our world-class antibody products and technologies. That three-pronged strategy – to turn science into medicine, build a profitable and successful biotech and focus on our core competence – led quickly to success. Just two years after we unveiled this strategy, we entered into two agreements with Janssen Biotech, Inc. (Janssen) that subsequently resulted in multiple approved medicines: DARZALEX® (daratumumab) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and the first approved DuoBody®-based antibody therapies RYBREVANT® (amivantamab) and TECVAYLI® (teclistamab). There is potential for an additional DuoBody-based medicine from this collaboration, as Janssen submitted a Biologics License Application (BLA) in December to the U.S. Food and Drug Administration (U.S. FDA) for talquetamab.
The approved medicines form part of the recurring revenue streams that we use to invest back into our company’s pipeline, technology and people. The results of this investment were on display in 2022. We celebrated the first full year of Genmab’s first approved medicine, Tivdak® (tisotumab vedotin-tftv), co-developed with Seagen Inc. (Seagen), being available for certain cervical cancer patients in the U.S. We submitted applications for our own DuoBody-based investigational medicine, epcoritamab, for approval in the U.S. and Japan and our partner AbbVie Inc. (AbbVie) followed suit in Europe. We expanded and advanced our clinical and pre-clinical portfolios, including an expansion of our successful collaboration with BioNTech SE (BioNTech), and we further scaled our organization to be aligned with our portfolio growth and potential future product launches.
A VISION ROOTED IN SCIENCE, INSPIRED BY PATIENTS
Soon after we launched our successful strategy, we articulated an ambitious vision for the company – that by 2025, our own product has transformed cancer treatment, and we have a pipeline of KYSO antibodies. To support this vision, we outlined how we would build our capabilities and teams, and we aligned on a series of goals and milestones that we committed to reaching by 2025. These ambitious goals were a roadmap to becoming the company that we knew we could be. I am proud that we have met most of those goals and many more are within reach, giving us an extremely solid foundation on which to continue to build Genmab. With these achievements, we felt that it was time to look beyond our 2025 Vision to continue impacting the
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GENMAB 2022 ANNUAL REPORT
lives of patients and the healthcare community into the future. Together with members of Genmab’s leadership team and colleagues throughout the organization, we discussed what would make us feel proud in 2030. We have captured our aspirations for the future with a new vision, that by 2030, our KYSO antibody medicines are fundamentally transforming the lives of people with cancer and other serious diseases.
Our 2030 Vision is not a reimagining of what Genmab is, but a bold expansion of what Genmab can be and how our unstoppable team aspires to use our innovation in antibody therapeutics to fundamentally transform the lives of patients. We know that our antibody know-how, assets and technologies can be applied to diseases outside cancer – the approvals of Novartis AG (Novartis)’s Kesimpta® (ofatumumab) in relapsing multiple sclerosis (RMS) and Horizon Therapeutics, plc (Horizon)’s TEPEZZA® (teprotumumab-trbw) in thyroid eye disease (TED) are proof of this. While we will continue to create and develop new treatment concepts in oncology, we will apply a rigorous approach in identifying areas outside of oncology where our science and expertise may potentially make the biggest difference for patients, with the ultimate goal of improving the lives of as many people as possible.
an unstoppable team, a kyso future
As a co-founder of Genmab, I am extremely motivated by the progress we have made, both since I became CEO and over the past year. As a scientist and immunologist, I am truly excited by the potential of our antibodies and by the possibilities for Genmab in 2023, 2030 and beyond.
I can say with confidence that this is not my story alone or the story of our global leadership team – it is the story of our talented and unstoppable Genmab team, of our collaboration partners who believe in the power of antibody therapies, of our supportive Board of Directors, the patients who participate in our clinical trials and their families, the investigators who help us trailblaze innovations, and our shareholders who believe in our vision. We are at the beginning of a fantastic KYSO future that we are creating together, and I thank you for your continued support.
Sincerely yours,
Jan van de Winkel, Ph.D.
President & Chief Executive Officer
2022 at a Glance
Operational
| ● | U.S. FDA granted orphan-drug designation to epcoritamab for the treatment of follicular lymphoma (FL) |
| ● | Publication by Genmab and collaboration partner AbbVie of topline results from the large B-cell lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 epcoritamab study |
| ● | New Phase 3 study for epcoritamab initiated |
| ● | Regulatory submissions for subcutaneous (SC) epcoritamab in the U.S. and Japan by Genmab and in Europe by AbbVie |
| ● | Epcoritamab BLA accepted for Priority Review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) target action date of May 21, 2023 |
| ● | Epcoritamab Marketing Authorization Application (MAA) validated by the European Medicines Agency (EMA) |
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| ● | First full year of Tivdak, co-development with Seagen, available for certain cervical cancer patients in the U.S. |
| ● | Continued development of commercialization capabilities and Genmab’s broader organizational infrastructure with the addition of 448 new colleagues |
| ● | Expansion of global strategic collaboration with BioNTech, including investigational medicine HexaBody®-CD27 (GEN1053/BNT313) |
| ● | Second DuoBody-based medicine to receive regulatory approval: Janssen’s TECVAYLI |
Financial
| ● | DKK 194B |
o | 2022 year-end market cap |
| ● | DKK 14,595M |
o | 2022 revenue |
| ● | DKK 8,238M |
o | 2022 operating expenses |
| ● | Liquidity and Capital Resources |
| o | Marketable securities – DKK 12,431M |
| o | Cash and cash equivalents – DKK 9,893M |
| o | Shareholders’ equity – DKK 27,441M |
2020 Operating Profit impacted by one-time AbbVie upfront payment.
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Consolidated Key Figures
(DKK million) | |||||||||
Income Statement | 2018* | 2019 | 2020 | 2021 | 2022 | ||||
Revenue | 3,025 | 5,366 | 10,111 | 8,482 | 14,595 | ||||
Research and development expenses | (1,431) | (2,386) | (3,137) | (4,181) | (5,562) | ||||
Selling, general and administrative expenses | (214) | (342) | (661) | (1,283) | (2,676) | ||||
Operating expenses | (1,645) | (2,728) | (3,798) | (5,464) | (8,238) | ||||
Operating profit | 1,380 | 2,638 | 6,313 | 3,018 | 6,357 | ||||
Net financial items | 232 | 221 | (409) | 965 | 678 | ||||
Net profit | 1,472 | 2,166 | 4,758 | 3,008 | 5,522 | ||||
Balance Sheet | |||||||||
Marketable securities | 5,573 | 7,419 | 8,819 | 10,381 | 12,431 | ||||
Cash and cash equivalents | 533 | 3,552 | 7,260 | 8,957 | 9,893 | ||||
Total non-current assets | 1,028 | 1,183 | 2,352 | 1,891 | 1,901 | ||||
Total assets | 8,461 | 15,144 | 21,143 | 24,627 | 30,278 | ||||
Shareholders' equity | 8,014 | 14,048 | 19,121 | 22,196 | 27,441 | ||||
Share capital | 61 | 65 | 66 | 66 | 66 | ||||
Cash Flow Statement | |||||||||
Cash flow from operating activities | 1,015 | 1,326 | 6,433 | 2,228 | 3,912 | ||||
Cash flow from investing activities | (1,778) | (1,983) | (2,351) | (961) | (2,761) | ||||
Cash flow from financing activities | (71) | 3,660 | 71 | (420) | (789) | ||||
Investments in intangible and tangible assets | (478) | (111) | (307) | (252) | (317) | ||||
Financial Ratios and Other Information | |||||||||
Basic net profit per share | 24.03 | 34.40 | 73.00 | 46.00 | 84.45 | ||||
Diluted net profit per share | 23.73 | 34.03 | 72.21 | 45.54 | 83.65 | ||||
Year-end share market price | 1,067.50 | 1,481.50 | 2,463.00 | 2,630.00 | 2,941.00 | ||||
Price / book value | 8.19 | 6.85 | 8.50 | 7.82 | 7.07 | ||||
Shareholders' equity per share | 130.32 | 216.12 | 289.71 | 336.30 | 415.77 | ||||
Equity ratio | 95% | 93% | 90% | 90% | 91% | ||||
Shares outstanding | 61,497,571 | 65,074,502 | 65,545,748 | 65,718,456 | 65,961,573 | ||||
Average number of employees (FTE)** | 313 | 471 | 656 | 1,022 | 1,460 | ||||
Number of employees (FTE) at year-end | 377 | 548 | 781 | 1,212 | 1,660 |
* Prior period amounts have not been adjusted under the modified retrospective method to adopt International Financial Reporting Standards (IFRS) 16 as of January 1, 2019
** Full-time equivalent (FTE) or team members
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2023 Outlook
(DKK million) | 2023 Guidance | 2022 Actual Result |
Revenue | 14,600 - 16,100 | 14,595 |
Operating expenses | (9,800) - (10,600) | (8,238) |
Operating profit | 3,900 - 6,200* | 6,357 |
*Operating profit does not sum due to rounding
Revenue
Genmab expects its 2023 revenue to be in the range of DKK 14,600 – 16,100 million, compared to DKK 14,595 million in 2022. Our revenue in 2022 was driven primarily by DARZALEX royalties due to the continued strong growth of DARZALEX net sales, favorable exchange rate movements between the USD and DKK and the positive impact of applying the DARZALEX contractual annual Currency Hedge Rate.
Genmab’s projected revenue growth for 2023 is driven by recurring revenues related to DARZALEX, TEPEZZA and Kesimpta royalties from net sales growth, partly offset by negative exchange rate movements between the USD and DKK due to a lower assumed USD/DKK exchange rate.
Genmab’s projected revenue for 2023 primarily consists of DARZALEX royalties of DKK 10,400 – 11,100 million. Such royalties are based on estimated DARZALEX 2023 net sales of USD 9.4 – 10.0 billion compared to actual net sales in 2022 of approximately USD 8.0 billion. DARZALEX royalties are partly offset by Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with SC net sales. The remainder of Genmab’s revenue consists of increasing royalties from TEPEZZA, Kesimpta, RYBREVANT and TECVAYLI, reimbursement revenue, milestones including those for epcoritamab and collaboration revenue with Seagen for Tivdak.
Operating Expenses
Genmab anticipates its 2023 operating expenses to be in the range of DKK 9,800 – 10,600 million, compared to DKK 8,238 million in 2022. The growth in operating expenses is to support Genmab’s continued portfolio advancement and investing for future product launches, including epcoritamab.
Operating Profit
Genmab expects our operating profit to be in the range of DKK 3,900 – 6,200 million in 2023, compared to DKK 6,357 million in 2022.
Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change for 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 and TECVAYLI net sales and royalties paid to Genmab; changing rates of inflation; and currency exchange rates (the 2023 guidance assumes a USD/DKK exchange rate of 6.8). The financial
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guidance assumes that no significant new agreements are entered into during 2023 that could materially affect the results. Additionally, depending on trends related to the coronavirus and future variants, the COVID-19 pandemic could potentially have a material adverse impact on Genmab’s business and financial performance, including clinical trials, projected regulatory approval timelines, supply chain and revenues, and cause Genmab’s actual results to differ materially from 2023 Guidance and Key 2023 Priorities in this annual report.
While global health authorities and global vaccination efforts alleviated some of the adverse impacts of the COVID-19 pandemic, should the global outbreak of COVID-19 persist, it may have long-term impacts on the development, regulatory approval and commercialization of Genmab’s investigational medicines and on net sales of approved medicines created by Genmab or that leverage Genmab’s DuoBody technology, which are developed and marketed by Genmab or Genmab’s collaboration partners. The factors discussed above, as well as other factors that are currently unforeseeable, may result in further and other unforeseen material adverse impacts on Genmab’s business and financial performance, including on the sales of Tivdak and on the net sales of DARZALEX, Kesimpta, TEPEZZA, RYBREVANT and TECVAYLI by Genmab’s collaboration partners and on Genmab’s royalties, collaboration revenue and milestone revenue therefrom.
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Our Strategy | |||
Business Strategy | Priorities in 2022 | Priorities for 2023 | Link to Risk |
Build a profitable and successful biotech ● Maintain a flexible and capital-efficient model ● Maximize relationships with partners ● Retain ownership of select products | Further scale organization aligned with growing product portfolio and brand needs ● Further scale organization aligned with differentiated antibody product portfolio growth and future launches ● Use solid financial base to grow and broaden antibody product and technology portfolio | Invest in our people and culture ● Further scale organization aligned with differentiated antibody product portfolio growth and future launches Become a leading integrated biotech innovation powerhouse ● Use solid financial base to grow and broaden antibody product and technology portfolio | Please refer to the risks included in this Annual Report. |
Focus on core competence ● Identify the best disease targets ● Develop unique first-in-class or best-in-class antibodies ● Develop next-generation technologies | Growth and development of differentiated early-stage product candidates ● DuoBody-PD-L1x4-1BB1 & DuoBody-CD40x4-1BB1 o Data from clinical expansion cohorts to progress to next steps ● Expand and advance proprietary clinical product portfolio | Build a world-class differentiated pipeline ● DuoBody-PD-L1x4-1BB o Establish proof of concept data in solid tumor indication ● DuoBody-CD40x4-1BB o Establish efficacy and safety data in solid tumor indication o Progress towards late-stage clinical development ● Expand and advance proprietary clinical product portfolio | Please refer to the risks included in this Annual Report. |
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Turn science into medicine ● Create differentiated antibody therapeutics with significant commercial potential | Broad and rapid development of late-stage clinical pipeline and further build U.S. country organization ● Epcoritamab2 o Expand clinical development program with multiple Phase 3 trials initiated and submission of first BLA (subject to supportive U.S. FDA feedback) ● Tivdak3 o Establish Tivdak as a clear choice for second-line (2L) + recurrent or metastatic cervical cancer patients ● Broaden clinical development program including Phase 2 evaluation of combination therapy in earlier line treatment for cervical cancer and other solid tumors | Bring our own medicines to patients ● Epcoritamab o Launch in relapsed/refractory diffuse large B-cell lymphoma (DLBCL)4 o Submit a supplemental BLA (sBLA)5 o Broaden clinical development program ● Tivdak o Progress successful uptake in 2L+ recurrent or metastatic cervical cancer patients o Progress clinical development program | Please refer to the risks included in this Annual Report. |
CSR Strategy | Priorities in 2022 | Priorities for 2023 | Link to Risk |
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Commitment to our business-driven Corporate Social Responsibility (CSR) strategy, which focuses on four pillars: ◾ Science-driven health innovations for patients ◾ Employee well-being and vitality ◾ Ethics and transparency ◾ Environmental and community sustainability | ◾ Continue strong commitment to being a responsible and sustainable biotech ◾ Look for opportunities to further integrate ESG into our strategic planning and risk management processes ◾ Monitor ESG matters of relevance to our business operations ◾ Establish clear goals to measure our performance ● Establish climate ambitions, targets, and emissions reductions and integrate climate-related financial risks into Genmab’s Enterprise Risk Management (ERM) program | ◾ Continue strong commitment to being a sustainable and responsible company ◾ Further integrate ESG into our strategic planning, operations and risk management processes ◾ Further formalize total CO2 emissions mapping ◾ Further define and communicate Genmab’s commitment to successfully attract, motivate, retain and reward top talent ◾ Enhance Diversity, Equity and Inclusion (DE&I) processes and efforts ◾ Monitor regulatory landscape and prepare for new ESG-related reporting requirements | Please refer to the risks included in Genmab’s 2022 Corporate Responsibility report, https://ir.genmab.com/static-files/72218610-90a6-4fd3-a76a-d4a7c9c6ef01 |
1. Co-development with BioNTech; 2. Co-development with AbbVie; 3. Co-development with Seagen; 4. Subject to regulatory approvals; 5. Subject to supportive U.S. FDA feedback
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 |
Genmab’s Growing Organization and Growing Presence
| ● | Copenhagen, DK |
| o | Headquarters |
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| o | Chemistry, Manufacturing and Controls (CMC) Operations |
| o | Clinical Operations |
| o | Corporate Functions |
| ● | Utrecht, NL |
| o | Research |
| o | Translational Research |
| o | Antibody Product Creation |
| o | Corporate Functions |
| ● | Princeton, USA |
| o | Translational Research |
| o | Development |
| o | U.S. Market Operations |
| o | Corporate Functions |
| ● | Tokyo, JP |
| o | Japan Clinical Operations |
| o | Japan Market Operations |
| o | Corporate Functions |
Our Key Accomplishments
Each of our achievements stands as evidence of our unyielding determination, including:
| ● | Tivdak, Genmab’s first approved medicine, co-developed and co-promoted in the U.S. in partnership with Seagen |
| ● | Five medicines that were created by Genmab, or that leverage Genmab’s DuoBody technology, are being developed and marketed by global pharmaceutical and biotechnology companies |
| ● | Inventors of four proprietary antibody technologies |
| ● | Growing proprietary clinical programs |
| ● | Pioneers of a robust pre-clinical pipeline |
| ● | Forty investigational new drug applications (INDs) filed by Genmab and/or partners, based on Genmab’s innovations and technology, since 1999 |
| ● | World-class team with deep antibody know-how, and R&D and commercial expertise |
| ● | Partnerships with industry leaders and innovators |
| ● | Solid financial foundation |
| ● | Building and expanding our capabilities with more than 1,600 team members across our international locations |
Business Model
At Genmab, we have built a profitable and successful biotech that creates value for our stakeholders.
Our Strengths and Differentiators
| ● | World-class antibody biology knowledge and deep insight into disease targets |
| ● | Discovery and development engine with proprietary technologies that allow us to build a world-class pipeline |
| ● | In-house expertise with a solid track record of building successful strategic partnerships |
| ● | Robust pipeline of potential best-in-class and first-in-class therapies |
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| ● | Experienced, diverse leadership team |
Building a Fully Integrated Biotech Innovation Powerhouse
| ● | Team: flexible and adaptive infrastructure |
| ● | Translational research and data science: key to accelerating development and ensuring the right therapies get to the right patients |
| ● | Collaboration: across innovation ecosystem of pharma, biotech and academia, drives our business forward |
| ● | Strong financials: growing recurring revenues and focused investments |
Research: track record of success and investing for tomorrow
Development: scaling up capabilities to expand from early- to late-stage development
Commercialization: building the next step in our evolution
Enabling functions: supporting growth and managing risk
The value we create for stakeholders
Patients
25 ongoing or announced clinical trials with Genmab owned (≥50%) products
Our People
448 new full-time jobs created in 2022
Investors
12% increase in market capitalization in 2022
Collaborations
Research agreements and collaborations in place across innovation ecosystem of pharma, biotech and academia
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 human antibody-based products. Our teams have established a fully integrated R&D enterprise and streamlined process to coordinate the activities of antibody product discovery, pre-clinical testing, manufacturing, clinical trial design and execution, and regulatory submissions across Genmab’s international operations. 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®.
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To connect patients with the right medicine at the right dose, we are also transforming Genmab; building on our world-class research in antibodies to expand our capabilities beyond the lab. We have expanded our scientific focus to use data science and artificial intelligence to aid in the discovery of new targets and biomarkers and bolster our in-depth translational medicine laboratory capabilities.
Sustainable and State-of-the-Art Facilities
The Netherlands
Genmab’s discovery and pre-clinical research is conducted at our R&D Center in Utrecht, the Netherlands, one of the first Building Research Establishment Environmental Assessment Method (BREEAM) Excellent laboratory buildings in the Netherlands. The R&D Center is located in close proximity to other life sciences companies and a world-class research university. It houses state-of-the-art laboratories including an advanced robotics lab, a modern auditorium, science café, and innovative brainstorming and meeting rooms. The space provides a bright, open and collaborative atmosphere to enable the Genmab team to continue to innovate and find new ways to help patients.
To accommodate Genmab’s growth, we will occupy most of the new “Accelerator” multi-tenant building, connected directly to the Genmab R&D Center. It is designed to achieve the same BREEAM Excellent high sustainability standard. Expansion into this building, which will contain both offices and laboratories, is expected in 2023.
United States
Genmab opened its new U.S. facility in 2020. This space, modeled on the open and collaborative spirit of the R&D Center in Utrecht, includes both offices and laboratories. The U.S. translational research laboratories allow Genmab to expand our translational pre-clinical and clinical drug development research expertise and are part of the strategic growth of the Company. As with the construction and design of 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. Additionally, 75% of the construction waste created when building out the facility was recycled, rather than being sent to a landfill.
As Genmab continues to grow our geographical footprint, we will endeavor to do so with minimal impact to the environment and with sustainability as a key area of focus.
Enhancing Commercialization Capabilities to Bring Our Innovations to Patients
Our 2030 Vision is for Genmab’s KYSO antibody medicines to fundamentally transform the treatment of cancer and other serious diseases. We are becoming an integrated end-to-end biotech innovation powerhouse that discovers, develops, and delivers next-generation antibody-based medicines to patients. Through the addition of key talent and the purposeful and strategic growth of our capabilities, we have never been in a better position to achieve our Vision.
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Key to our ability to bring our medicines to patients is commercialization. Over the past few years, we have made tremendous progress in building and establishing this important capability, first in the U.S. and Japan, through a disciplined and integrated approach.
| ● | In the third quarter of 2021, together with our partner Seagen, we launched our first marketed medicine, Tivdak, in the U.S. Since its launch, Tivdak is on the way to becoming the clear second-line choice for women with recurrent or metastatic cervical cancer with more than 900 women estimated to have received treatment as of December 2022. |
| ● | We continue to expand our capabilities as we prepare for the potential launch of epcoritamab in the U.S. and Japan, pending regulatory approvals, by deepening our talent base, focusing on impactful approaches and optimal access for all appropriate patients. |
| ● | Our commercialization team is anchored in highly experienced leaders and teams across functions: medical affairs, marketing, market access, insights and analytics as well as field-based teams in the U.S. to ensure the best possible experience for care teams and their patients treated with our medicines. |
| ● | We have built a global commercial team to help shape our development and go-to-market strategy in close partnership with R&D. Building a deep understanding of the potential and evolution of markets/segments will help ensure a thoughtful approach to advancing our pipeline. |
At Genmab, commercialization is an integrated approach guided by our commitment to the patients we serve; everyone doing their part to ensure patients get the most from our next-generation differentiated antibody-based medicines.
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 with the commercialization and launch of our first medicine, co-owned with Seagen, in 2021, and we are preparing for the potential launch of our second medicine in 2023 under our collaboration with AbbVie.
Products and Technologies
Pipeline
At the end of 2022, Genmab’s proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of nine antibodies in clinical development. These include Genmab’s first U.S. FDA approved medicine, Tivdak, which Genmab is co-developing with Seagen and co-promoting in the U.S. In addition to our own pipeline, there are multiple investigational medicines in development by global pharmaceutical and biotechnology companies, including five approved medicines powered by Genmab’s technology and innovations. Beyond the investigational medicines in clinical development, our pipeline also includes multiple pre-clinical programs. An overview of the development status of our approved medicine and of each of our 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 A/S (Nasdaq Copenhagen) stock exchange and may also be found in Genmab’s filings with the U.S. Securities and Exchange Commission (SEC). Additional
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information is available on Genmab’s website, www.genmab.com. The information accessible through our website is not part of and is not incorporated by reference herein.
Genmab’s Proprietary Pipeline (≥50% Genmab ownership)*
Approved Medicine
Tivdak (tisotumab vedotin-tftv)
Clinical Stage Investigational Medicines
Epcoritamab
DuoBody-PD-L1x4-1BB (GEN1046/BNT311)
DuoBody-CD40x4-1BB (GEN1042/BNT312)
DuoHexaBody-CD37 (GEN3009)
HexaBody-CD38 (GEN3014)
DuoBody-CD3xB7H4 (GEN1047)
HexaBody-CD27 (GEN1053/BNT313)
GEN1056 (BNT322)
* Tisotumab vedotin co-development with Seagen; epcoritamab co-development with AbbVie; DuoBody-PD-L1x4-1BB, DuoBody-CD40x4-1BB, HexaBody-CD27 and GEN1056 co-development with BioNTech; Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen.
Programs Incorporating Genmab’s Innovations and Technology in Phase 2 Development or Later
Approved Medicines
DARZALEX/DARZALEX FASPRO (daratumumab/daratumumab and hyaluronidase-fihj, Janssen)
Kesimpta (ofatumumab, Novartis)
TEPEZZA (teprotumumab-trbw, Horizon)
RYBREVANT (amivantamab, Janssen)
TECVAYLI (teclistamab, Janssen)
≥ Phase 2 Clinical Stage Investigational Medicines
Talquetamab (Janssen)
Inclacumab (Global Blood Therapeutics, now owned by Pfizer)
Mim8 (Novo Nordisk A/S (Novo Nordisk))
Camidanlumab tesirine (ADC Therapeutics)
PRV-015 (Provention Bio)
Lu AF82422 (Lundbeck)
Additional investigational medicines are in early-stage clinical development.
Genmab’s Proprietary1 Products
Approved Medicine
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Approved Product | Target | Developed By | Disease Indication |
Tivdak (tisotumab vedotin-tftv) | Tissue factor (TF) | Co-development Genmab/Seagen | Adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy2 |
1Approved and investigational medicines where Genmab has ≥50% ownership, in co-development with partners as indicated.
2Refer to local country prescribing information for precise indication and safety information.
Pipeline, Including Further Development for Approved Medicine
1In June 2022, AbbVie decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of the 180-day notice period on December 24, 2022, Genmab became solely responsible for the further development of DuoHexaBody-CD37 against low-single digit royalty payments to AbbVie, up to an agreed maximum total royalty amount, based on future potential sales of the product.
2Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen.
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Programs Incorporating Genmab’s Innovation and Technology1
Approved Medicines
Approved Product | Discovered and/or Developed & Marketed By | Disease Indication(s) |
DARZALEX (daratumumab)/DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) | Janssen (Royalties to Genmab on net global sales) | Multiple myeloma2 |
Light-chain (AL) Amyloidosis | ||
Kesimpta (ofatumumab) | Novartis (Royalties to Genmab on net global sales) | RMS2 |
TEPEZZA (teprotumumab-trbw) | Horizon (under sublicense from Roche, royalties to Genmab on net global sales) | TED2 |
RYBREVANT (amivantamab/amivantamab-vmjw) | Janssen (Royalties to Genmab on net global sales) | NSCLC2 |
TECVAYLI (teclistamab/teclistamab-cqyv) | Janssen (Royalties to Genmab on net global sales) | Relapsed and refractory multiple myeloma2 |
1Approved and investigational medicines created by Genmab or created by collaboration partners leveraging Genmab’s DuoBody technology platform, under development, and where relevant, commercialized by a third party.
2See local prescribing information for precise indication and safety information.
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Pipeline, Including Further Development for Approved Medicines, ≥Phase 2 Development
*UltiMab transgenic mouse technology licensed from Medarex, Inc. (Medarex), a wholly owned subsidiary of Bristol-Myers Squibb
Genmab’s Proprietary Pipeline
Programs where Genmab has ≥50% ownership.
Tivdak (tisotumab vedotin-tftv)
First and Only U.S. FDA Approved Antibody-drug Conjugate (ADC) for Recurrent or Metastatic Cervical Cancer
| ● | An ADC directed to TF, a protein highly prevalent on solid tumors, including cervical cancer, which is associated with poor prognosis |
| ● | Accelerated approval granted by the U.S. FDA for Tivdak, the first and only approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy |
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| ● | U.S. FDA approval was based on data from the innovaTV 204 (NCT03438396) Phase 2 single-arm clinical study evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer |
| ● | In addition to a Phase 3 study in recurrent or metastatic cervical cancer (innovaTV 301, NCT04697628), clinical studies in other solid tumors are ongoing |
| ● | Co-developed globally and co-promoted in the U.S. in collaboration with Seagen |
Tisotumab vedotin is an ADC composed of Genmab’s human monoclonal antibody directed to TF and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E 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 U.S. FDA approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin is being co-developed by Genmab and Seagen. Under a joint commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and will lead commercial operational activities in Japan. Seagen is leading commercial operational activities in the U.S. and will lead commercial operational activities in Europe and China. In these four markets there will be a 50:50 cost and profit split. In other markets, Seagen will commercialize Tivdak and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. 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 Seagen. The companies have a broad clinical development program for tisotumab vedotin, including a confirmatory Phase 3 study in recurrent or metastatic cervical cancer.
Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety information, including the boxed warning.
KEY ONGOING clinical TRIALS
About Cervical Cancer1
· | Cancer that originates in the cells lining the cervix |
· | Fourth most frequently diagnosed and fourth most deadly cancer in women worldwide2 |
· | In developing regions, ranked second in incidence and mortality in women2 |
| ● | In 2022, an estimated 14,100 new cases of invasive cervical cancer will be diagnosed, and 4,280 women will die from the disease in the U.S.3 |
| ● | Up to 16% of women initially present with metastatic cervical cancer3 |
| ● | Among women who present with earlier stage disease, 15%-61% will go on to develop metastatic cervical cancer, most commonly within the first two years following completion of therapy4 |
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| ● | 5-year survival rate for women in the U.S. and Japan with recurrent or metastatic cervical cancer is only 17.1% and 19.5%, respectively, highlighting an urgent unmet need for effective treatment3 |
1 General statistics include all stages of cervical cancer.
2 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians. 2018;68(6):394-424.
3 Institute NC. SEER Cancer Stat Facts: Cervical Cancer. 2022. https://seer.cancer.gov/statfacts/html/cervix.html. Accessed November 21, 2022.
4 Pfaendler KS, Tewari KS. Changing paradigms in the systemic treatment of advanced cervical cancer. Am J Obstet Gynecol. 2016;214(1):22-30.
UPDATES FROM FIRST QUARTER TO THIRD QUARTER
| ● | June: Genmab and Seagen presented multiple tisotumab vedotin abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting, including interim data from the Phase 1b/2 innovaTV 205 (NCT03786081) study of tisotumab vedotin, which was presented during an oral session. The ongoing innovaTV 205 study is evaluating tisotumab vedotin as monotherapy and in combination with other agents in recurrent or metastatic cervical cancer. |
| ● | March: Genmab and Seagen presented interim data from two cohorts of the Phase 1b/2 innovaTV 205 study of tisotumab vedotin as a virtual oral presentation at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. |
| ● | February: Genmab and Seagen presented preliminary data from the Phase 2 innovaTV 207 (NCT03485209) study of tisotumab vedotin as part of a plenary session at the American Society for Radiation Oncology (ASTRO) 2022 Multidisciplinary Head and Neck Cancers Symposium. The ongoing innovaTV 207 study is evaluating the activity, safety and tolerability of tisotumab vedotin in selected solid tumors with high TF expression. The data presented at ASTRO was from the squamous cell carcinoma of the head and neck (SCCHN) cohort of the study, which is evaluating tisotumab vedotin as monotherapy in patients with SCCHN who experienced disease progression on or after a first-line platinum-containing regimen and a checkpoint inhibitor. |
Epcoritamab (DuoBody-CD3xCD20)
Potential Best-in-Class Investigational Medicine
| ● | Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology |
| ● | Multiple ongoing clinical studies across different settings and histologies, including Phase 3 studies in DLBCL (EPCORE DLBCL-1, NCT04628494) and FL (EPCORE FL-1, NCT05409066) with more studies in planning |
| ● | In the second half of 2022, Genmab submitted a BLA to the U.S. FDA and a Japan New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan for SC epcoritamab for the treatment of patients with relapsed/refractory LBCL. AbbVie submitted an MAA to the EMA for SC epcoritamab for the treatment of patients with relapsed/refractory DLBCL. The BLA was subsequently accepted for Priority Review by the U.S. FDA and the MAA was validated by the EMA. The U.S. FDA set a PDUFA date of May 21, 2023 |
| ● | The regulatory submissions were supported by results from the LBCL cohort of the pivotal EPCORE NHL-1 (NCT03625037) trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including DLBCL |
| ● | Co-developed in collaboration with AbbVie |
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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. In 2020, Genmab entered into a broad oncology collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab will book sales in the U.S. and Japan and receive tiered royalties on remaining global sales outside of these territories. Please refer to Note 5.6 of the financial statements for further details regarding the epcoritamab collaboration with AbbVie. The companies have a broad clinical development program for epcoritamab, including two Phase 3 studies ongoing, and additional studies in planning.
FOURTH QUARTER UPDATES
| ● | December: Publication in the Journal of Clinical Oncology, “Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell–Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial.” |
| ● | December: Genmab submitted to the MHLW a JNDA for SC epcoritamab for the treatment of patients with relapsed/refractory LBCL after two or more lines of systemic therapy. |
| ● | December: Multiple presentations at the 64th American Society of Hematology (ASH) Annual Meeting, including four oral presentations. |
| ● | November: The U.S. FDA accepted the BLA for SC epcoritamab for Priority Review. The U.S. FDA set a PDUFA date of May 21, 2023. Based on Genmab’s agreement with AbbVie this event triggered a milestone payment of USD 80 million to Genmab. |
| ● | October: AbbVie submitted an MAA to the EMA for SC epcoritamab for the treatment of patients with relapsed/refractory DLBCL after two or more lines of systemic therapy. This was subsequently validated by the EMA, an event that triggered a milestone payment of USD 60 million to Genmab. |
UPDATES FROM FIRST QUARTER TO THIRD QUARTER
| ● | September: Genmab submitted a BLA to the U.S. FDA for SC epcoritamab for the treatment of patients with relapsed/refractory LBCL after two or more lines of systemic therapy. |
| ● | June: Genmab and AbbVie presented multiple epcoritamab abstracts at both the ASCO Annual Meeting and the 27th Annual Meeting of the European Hematology Association (EHA). Data from the first cohort of the EPCORE NHL-1 trial of epcoritamab in relapsed/refractory LBCL was presented as a late-breaking oral presentation during the Presidential Symposium at EHA. |
| ● | April: Genmab and AbbVie announced topline results from the first cohort of the Phase 1/2 EPCORE NHL-1 trial of epcoritamab in relapsed/refractory LBCL. |
| ● | March: The U.S. FDA granted orphan-drug designation to epcoritamab for the treatment of FL. |
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Key ongoing clinical Trials
About Diffuse Large B-cell Lymphoma
| ● | DLBCL is an aggressive type of NHL that develops from B cells1 |
| ● | DLBCL is the most common type of NHL in the U.S. and worldwide1 |
| ● | 64.6% 5-year survival rate2 |
| ● | Prognosis for relapsed or refractory DLBCL patients is poor, especially for those with high-risk factors3 |
| ● | For most patients with refractory DLBCL there are no curative treatment options3 |
1Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/ Accessed December 2, 2022.
2National Institutes of Health. SEER Cancer Stat Facts: DLBCL. https://seer.cancer.gov/statfacts/html/dlbcl.html. Accessed November 21, 2022.
3Crump, Michael, et al. “Outcomes in Refractory Diffuse Large B-Cell Lymphoma: Results from the International SCHOLAR-1 Study.” Blood, American Society of Hematology, 19 Oct. 2017, www.ncbi.nlm.nih.gov/pmc/articles/PMC5649550/.
DuoBody-PD-L1x4-1BB (GEN1046/BNT311)
Bispecific Next-Generation Immunotherapy
| ● | Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology platform |
| ● | Clinical studies in solid tumors ongoing, including a Phase 2 study in NSCLC (NCT05117242) |
| ● | Co-developed in collaboration with BioNTech |
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DuoBody-PD-L1x4-1BB is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for DuoBody-PD-L1x4-1BB on a 50:50 basis. DuoBody-PD-L1x4-1BB is designed to induce an antitumor immune response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation using an inert DuoBody format. Three clinical studies in solid tumors are ongoing including a Phase 2 study of DuoBody-PD-L1x4-1BB as monotherapy or in combination with pembrolizumab in patients with recurrent metastatic NSCLC.
DuoBody-CD40x4-1BB (GEN1042/BNT312)
Potential First-in-Class Bispecific Agonistic Antibody
| ● | Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology platform |
| ● | Phase 1/2 clinical study (NCT04083599) in solid tumors ongoing |
| ● | Co-developed in collaboration with BioNTech |
DuoBody-CD40x4-1BB is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for DuoBody-CD40x4-1BB on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells and antigen-dependent T-cell activation, using an inert DuoBody format. A Phase 1/2 clinical study of DuoBody-CD40x4-1BB in solid tumors is ongoing.
FOURTH QUARTER UPDATE
| ● | December: Combination safety data and early encouraging anti-tumor activity in SCCHN patients treated with chemotherapy, pembrolizumab and DuoBody-CD40x4-1BB was presented at the European Society for Medical Oncology Immuno-Oncology Annual Congress. |
DuoHexaBody-CD37 (GEN3009)
First DuoHexaBody Program in Clinical Development
| ● | Antibody-based investigational medicine created with Genmab’s DuoHexaBody technology platform |
| ● | Phase 1/2 clinical study (NCT04358458) in hematologic malignancies ongoing |
DuoHexaBody-CD37 is a bispecific antibody that targets two non-overlapping CD37 epitopes, created using Genmab’s DuoHexaBody technology platform. The DuoHexaBody technology platform combines the dual targeting of our DuoBody technology platform with the enhanced potency of our HexaBody technology platform, creating bispecific antibodies with target-mediated enhanced hexamerization. A Phase 1/2 clinical study in hematologic malignancies, including the potential for combination with epcoritamab, is ongoing.
UPDATE FROM FIRST QUARTER TO THIRD QUARTER
| ● | June: AbbVie decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of the 180-day notice period on December 24, 2022, Genmab became solely responsible for the further |
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| development of DuoHexaBody-CD37 against low-single digit royalty payments to AbbVie, up to an agreed maximum total royalty amount, based on future potential sales of the product. |
HexaBody-CD38 (GEN3014)
HexaBody-based Investigational Medicine with Potential in Hematological Malignancies
| ● | Antibody-based investigational medicine created with Genmab’s HexaBody technology platform |
| ● | Phase 1/2 clinical study (NCT04824794) in hematological malignancies ongoing |
| ● | Developed in an exclusive worldwide license and option agreement with Janssen |
HexaBody-CD38 is a human CD38 monoclonal antibody-based investigational medicine created using Genmab’s HexaBody technology platform. In pre-clinical models of hematological malignancies, HexaBody-CD38 demonstrated highly potent complement-dependent cytotoxicity and showed potent anti-tumor activity. In June 2019, Genmab entered into an exclusive worldwide license and option agreement with Janssen to develop and commercialize HexaBody-CD38. A Phase 1/2 clinical study in hematologic malignancies is ongoing and includes an arm comparing HexaBody-CD38 to daratumumab in anti-CD38 monoclonal antibody-naïve relapsed or refractory multiple myeloma patients.
FOURTH QUARTER UPDATE
| ● | December: Poster presentation of preliminary dose-escalation results presented at the 64th ASH Annual Meeting. |
DuoBody-CD3xB7H4 (GEN1047)
Bispecific with Potential in Solid Tumors
| ● | Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology platform |
| ● | Phase 1/2 clinical study (NCT05180474) in malignant solid tumors ongoing |
DuoBody-CD3xB7H4 is a bispecific antibody-based investigational medicine created using Genmab’s DuoBody technology platform. B7H4 is an immune checkpoint protein expressed on malignant cells in various solid cancers including breast, ovarian and lung cancer. In pre-clinical studies, DuoBody-CD3xB7H4 induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. DuoBody-CD3xB7H4 is being developed for the potential treatment of solid cancer indications known to express B7H4. A Phase 1/2 clinical study of DuoBody-CD3xB7H4 in malignant solid tumors is ongoing.
UPDATE FROM FIRST QUARTER TO THIRD QUARTER
| ● | January: The first patient was dosed in the first-in-human Phase 1/2 study of DuoBody-CD3xB7H4 in patients with malignant solid tumors. |
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HexaBody-CD27 (GEN1053/BNT313)
HexaBody-based Investigational Medicine with Potential in Solid Tumors
| ● | Antibody-based investigational medicine created with Genmab’s HexaBody technology platform |
| ● | Phase 1/2 clinical study (NCT05435339) in solid tumors ongoing |
| ● | Co-developed in collaboration with BioNTech |
HexaBody-CD27 is a CD27 antibody that utilizes Genmab’s HexaBody technology, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of T cells. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for HexaBody-CD27 on a 50:50 basis. A Phase 1/2 clinical study of HexaBody-CD27 in solid tumors is ongoing.
FOURTH QUARTER UPDATEs
| ● | November: The first patient was dosed in the first-in-human Phase 1/2 study of HexaBody-CD27 in patients with malignant solid tumors. |
| ● | November: First pre-clinical disclosure during the Society for Immunotherapy of Cancer 37th Annual Meeting. |
UPDATE FROM FIRST QUARTER TO THIRD QUARTER
| ● | May: IND application and first Clinical Trial Application (CTA) submitted for HexaBody-CD27. |
GEN1056 (BNT322)
First-in-Human Study Recruiting
| ● | Phase 1 clinical study (NCT05586321) in solid tumors ongoing |
| ● | Co-developed in collaboration with BioNTech |
GEN1056 is an antibody product being co-developed by Genmab and BioNTech for the treatment of solid tumors and for use in combination with other products. A first-in-human Phase 1 clinical study of GEN1056 in patients with advanced solid tumors is ongoing.
FOURTH QUARTER UPDATE
| ● | November: The first patient was dosed in the first-in-human Phase 1 study of GEN1056. |
UPDATE FROM FIRST QUARTER TO THIRD QUARTER
| ● | July: The first CTA was submitted for GEN1056. |
Pre-clinical Programs
| ● | Broad pre-clinical pipeline that includes both partnered products and in-house programs based on our proprietary technologies and/or antibodies |
| ● | Multiple new INDs expected to be submitted over the coming years |
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| ● | Genmab has entered multiple strategic collaborations to support the expansion of our innovative pipeline |
Our pre-clinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody technology platform and bispecific antibodies created with our DuoBody technology platform. We are also collaborating with our partners to generate additional new antibody-based product concepts. A number of the pre-clinical programs are conducted in cooperation with our collaboration partners.
UPDATE FROM FIRST QUARTER TO THIRD QUARTER
| ● | August: Genmab and BioNTech expanded the companies’ global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients. Under the expansion, the companies will jointly develop and commercialize, subject to regulatory approval, other formats including monospecific antibodies leveraging Genmab’s proprietary HexaBody technology platform. |
Approved Medicines Incorporating Genmab’s Innovations and Technology
In addition to Genmab’s own pipeline of investigational medicines, our innovations and proprietary technology platforms are applied in the pipelines of global pharmaceutical and biotechnology companies. These companies are running clinical development programs with antibodies created by Genmab or created using Genmab’s DuoBody bispecific antibody technology platform. The programs run from Phase 1 development to approved medicines.
The information in this section includes those medicines that have been approved by regulatory agencies in certain territories. Under the agreements for these medicines Genmab is entitled to certain potential milestones and royalties.
DARZALEX (daratumumab)
Redefining the Treatment of Multiple Myeloma
| ● | First-in-class human CD38 monoclonal antibody |
| ● | Developed and commercialized by Janssen under an exclusive worldwide license from Genmab |
| ● | Intravenous (IV) formulation approved in combination with other therapies and as monotherapy for certain multiple myeloma indications |
| ● | First and only SC CD38-directed antibody approved for the treatment of certain multiple myeloma indications, known as DARZALEX FASPRO in the U.S., and as DARZALEX SC in Europe |
| ● | SC daratumumab is the first and only approved therapy for AL amyloidosis in the U.S., Europe and Japan |
| ● | 2022 net sales of DARZALEX by Janssen were USD 7,977 million |
Daratumumab is a human monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells and is also expressed by AL amyloidosis plasma
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cells. Genmab used technology licensed from Medarex to generate the CD38 antibody. Daratumumab is being developed by Janssen under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab. Under the terms of the agreement, Genmab is entitled to double digit royalties between 12% and 20% with Janssen reducing such royalty payments for Genmab’s share of Janssen’s royalty payments made to Halozyme. Please refer to Note 5.6 of the financial statements for further details regarding the daratumumab collaboration with Janssen. Daratumumab (marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the U.S. and as DARZALEX SC in Europe for SC administration) is approved in a large number of territories for the treatment of adult patients with certain multiple myeloma indications and is the only approved therapy in the U.S., Europe and Japan for the treatment of adult patients with AL amyloidosis.
Please consult the European Summary of Product Characteristics for DARZALEX and DARZALEX SC and the U.S. Prescribing Information for DARZALEX and DARZALEX FASPRO for the labeled indication and safety information.
Kesimpta (ofatumumab)
Approved in the Treatment of RMS
| ● | Human CD20 monoclonal antibody developed and commercialized by Novartis under a license agreement with Genmab |
| ● | Approved in territories including the U.S., EU and Japan for treatment of RMS in adults |
| ● | First B-cell therapy that can be self-administered by patients at home or anywhere using the Sensoready® autoinjector pen |
Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. Genmab used technology licensed from Medarex to generate the CD20 antibody. Ofatumumab, marketed as Kesimpta, is approved in territories including the U.S., Europe and Japan for the treatment of certain adult patients with RMS. Kesimpta is the first B-cell therapy that can be self-administered by patients at home or anywhere using the Sensoready autoinjector pen, once monthly after starting therapy. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis. Under the terms of the agreement, Genmab is entitled to 10% royalties on net sales of Kesimpta. Please refer to Note 5.6 of the financial statements for further details regarding the ofatumumab collaboration with Novartis.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for the labeled indication and safety information for Kesimpta.
TEPEZZA (teprotumumab-trbw)
First U.S. FDA Approved Medicine for the Treatment of TED
| ● | Developed and commercialized by Horizon for the treatment of TED |
| ● | First and only U.S. FDA approved medicine for the treatment of TED |
| ● | Also being explored in a clinical trial for the treatment of diffuse cutaneous systemic sclerosis (dcSSC) |
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Teprotumumab, approved by the U.S. FDA under the trade name TEPEZZA, is a human monoclonal antibody that targets the Insulin-like Growth Factor 1 Receptor (IGF-1R), a validated target. Genmab used technology licensed from Medarex to generate the IGF-1R antibody. The antibody was created by Genmab under a collaboration with Roche and development and commercialization of the product is now being conducted by Horizon under a sublicense from Roche. Under the terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on net sales of TEPEZZA. Please refer to Note 5.6 of the financial statements for further details regarding the teprotumumab collaboration.
Please consult the U.S. Prescribing Information for the labeled indication and safety information for TEPEZZA.
RYBREVANT (amivantamab)
First Regulatory Approvals for a DuoBody-based Medicine
| ● | Part of Genmab and Janssen DuoBody research and license agreement |
| ● | First approved medicine created using Genmab’s proprietary DuoBody technology platform |
| ● | Under the agreement with Janssen, Genmab will receive milestones and royalties on net sales of RYBREVANT |
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of these, Janssen’s amivantamab, is a fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and cMet, two validated cancer targets. The two antibody libraries used to produce amivantamab were both generated by Genmab. In collaboration with Janssen, the antibody pair used to create amivantamab was selected. Janssen is responsible for the development and commercialization of amivantamab.
In 2021, Janssen received approvals in the U.S., Europe and other markets for amivantamab, marketed as RYBREVANT, for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations. These were the first regulatory approvals for a therapy that was created using Genmab’s proprietary DuoBody bispecific technology platform. Under our agreement with Janssen, Genmab will receive milestones and royalties between 8% and 10% on net sales of RYBREVANT. Please refer to Note 5.6 of the financial statements for further details regarding the DuoBody collaboration with Jansen.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for RYBREVANT for the labeled indication and safety information.
TECVAYLI (teclistamab)
Bispecific Antibody Approved for the Treatment of Relapsed and Refractory Multiple Myeloma
| ● | Part of Genmab and Janssen DuoBody research and license agreement |
| ● | Second approved medicine created using Genmab’s proprietary DuoBody technology platform |
| ● | Under the agreement with Janssen, Genmab will receive milestones and royalties on net sales of TECVAYLI |
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In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of the products subsequently discovered and developed by Janssen is teclistamab, a bispecific antibody that targets CD3, which is expressed on T-cells and B-cell maturation antigen (BCMA), which is expressed on mature B lymphocytes.
In August 2022, Janssen received conditional marketing authorization from the European Commission for subcutaneously administered teclistamab, marketed as TECVAYLI, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and a CD38 antibody and have demonstrated disease progression on the last therapy. In October 2022, Janssen received U.S. FDA approval of TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
TECVAYLI is the second therapy created using Genmab’s proprietary DuoBody bispecific technology platform to receive regulatory approval. Under our agreement with Janssen, Genmab will receive milestones and a mid-single digit royalty on net sales of TECVAYLI. Please refer to Note 5.6 of the financial statements for further details regarding the DuoBody collaboration with Jansen.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for TECVAYLI for the labeled indication and safety information.
Antibody Technologies
Antibodies are Y-shaped proteins that play a central role in immunity against bacteria and viruses (also known as pathogens). As we develop immunity, our bodies generate antibodies that bind to pathogen structures (known as antigens), which are specific to the pathogen. Once bound, the antibodies attract other parts of the immune system to eliminate the pathogen. In modern medicine, we have learned how to create and develop specific antibodies against antigens associated with diseased human cells for use in the treatment of diseases such as cancer and autoimmune disease. Genmab uses several types of technologies to create antibodies to treat disease and has developed proprietary antibody technologies including the DuoBody, HexaBody, DuoHexaBody and HexElect technology platforms. Information about these technologies can be found in the following sections and at www.genmab.com/research-innovation/antibody-technology-platforms/.
We also use or license several other technologies to generate diverse libraries of high-quality, functional antibodies. In addition, we use or license technologies to increase the potency of some of our antibody therapeutics on a product-by-product basis, including ADCs. ADCs are antibodies with potent cytotoxic agents coupled to them. By using antibodies that recognize specific targets on tumor cells, these cytotoxic agents are preferentially delivered to the tumor cells.
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Our Proprietary Technology Platform Suite
Platform | Principle | Applications | |
DuoBody |
| Bispecific antibodies | Dual-targeting: · Recruitment (e.g., T cells) · Tumor heterogeneity |
HexaBody |
| Target-mediated enhanced hexamerization | Enhanced potency: · Complement-dependent cytotoxicity (CDC) · Target clustering, outside-in signaling, apoptosis |
DuoHexaBody |
| Bispecific antibodies with target-mediated enhanced hexamerization | Dual-targeting + enhanced potency: · CDC · Target clustering, outside-in signaling, apoptosis |
HexElect |
| Two co-dependent antibodies with target-mediated enhanced hexamerization | Dual-targeting + enhanced potency and selectivity: · Co-dependent unlocking of potency · New target space, previously inaccessible |
DuoBody Technology Platform
Innovative Technology for Bispecific Antibody Therapeutics
| ● | Bispecific antibody technology platform |
| ● | Potential in cancer, autoimmune, infectious, cardiovascular, central nervous system diseases and hemophilia |
| ● | Commercial collaborations with AbbVie, Janssen and BioNTech among others, plus multiple research collaborations |
| ● | First regulatory approvals for medicines created using the DuoBody technology platform – Janssen’s RYBREVANT and TECVAYLI |
| ● | In the second half of 2022, Genmab submitted a BLA to the U.S. FDA and a JNDA to the MHLW for SC epcoritamab for the treatment of patients with relapsed/refractory LBCL. AbbVie submitted an MAA to the EMA for SC epcoritamab for the treatment of patients with relapsed/refractory DLBCL |
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The DuoBody technology platform is Genmab’s innovative platform for the discovery and development of bispecific antibodies. Bispecific antibodies bind to two different epitopes (or “docking” sites) either on the same or on different targets (also known as dual-targeting). Dual-targeting may improve binding specificity and enhance therapeutic efficacy or bring two different cells together (for example, engaging a T cell to kill a tumor cell). Bispecific antibodies generated with the DuoBody technology platform can be used for the development of therapeutics for diseases such as cancer, autoimmune, infectious, cardiovascular, central nervous system diseases and hemophilia. DuoBody molecules combine the benefits of bispecificity with the strengths of conventional antibodies, which allows DuoBody molecules to be administered and dosed the same way as other antibody therapeutics. Genmab’s DuoBody technology platform generates bispecific antibodies via a versatile and broadly applicable process that is easily performed at high throughput, standard bench, as well as at commercial manufacturing scale. Genmab uses the DuoBody technology platform to create its own bispecific antibody programs and the technology is also available for licensing. Genmab has numerous alliances for the DuoBody technology platform including commercial collaborations with AbbVie, Janssen, Novo Nordisk, BioNTech and Immatics.
Genmab’s proprietary DuoBody technology platform has been applied to a variety of bispecific antibody products in development, both in our own pipeline and in programs being developed by collaboration partners. The technology has been validated by the continued advancement of these investigational medicines through clinical development, including two medicines approved in both the U.S. and in Europe.
The innovative DuoBody technology platform generates bispecific antibodies via a fast, versatile and broadly applicable process called controlled Fab-arm exchange. With only minimal protein engineering, the technology allows the binding arms of two distinct monoclonal antibodies to exchange, combining into one stable bispecific antibody, thereby retaining regular immunoglobulin structure and function. The DuoBody technology platform is also highly suitable for high throughput generation, screening and discovery of bispecific antibodies in final therapeutic format. |
DuoBody Collaborations
Advancing Our Pipeline
AbbVie
On June 10, 2020, Genmab entered into a broad oncology collaboration agreement with AbbVie to jointly develop and commercialize products including epcoritamab (DuoBody-CD3xCD20), and subsequently into a discovery research collaboration for up to four future differentiated antibody therapeutics for cancer. The companies will share commercial responsibilities for epcoritamab in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab will be the principal for net sales in the U.S. and Japan and will receive tiered royalties on remaining global sales outside of these territories. For any product candidates developed as a result of the companies’ discovery research collaboration, Genmab and AbbVie will share responsibilities for global development and commercialization in the U.S. and Japan. Genmab retains the right to co-commercialize these products, along with AbbVie, outside of the U.S. and Japan.
Under the terms of the agreement, Genmab has the potential to receive regulatory and sales milestone payments, as well as tiered royalties between 22% and 26% on net sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales, the parties will share in pre-tax profits from the potential sale of epcoritamab on a 50:50 basis. If all four next-generation antibody product candidates developed as a
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result of the discovery research collaboration are successful, Genmab is eligible to receive up to USD 2.0 billion in option exercise and success-based milestones. Genmab and AbbVie split 50:50 the development costs related to epcoritamab, while Genmab will be responsible for 100% of the costs for the discovery research programs up to opt-in. Please refer to Note 5.6 of the financial statements for further details regarding the collaboration with AbbVie.
BioNTech
In May 2015, Genmab entered an agreement with BioNTech to jointly research, develop and commercialize bispecific antibody-based investigational medicines using Genmab’s DuoBody technology platform. Under the terms of the agreement, BioNTech will provide proprietary antibodies against key immunomodulatory targets, while Genmab provides proprietary antibodies and access to its DuoBody technology platform. Genmab paid an upfront fee of USD 10 million to BioNTech. If the companies jointly select any antibody-based product candidates for clinical development, development costs and product ownership will be shared equally going forward. If one of the companies does not wish to move an antibody product forward, the other company is entitled to continue developing it on predetermined licensing terms. The agreement also includes provisions which will allow the parties to opt out of joint development at key points. Genmab and BioNTech selected two antibody products for clinical development, DuoBody-CD40x4-1BB (GEN1042/BNT312) and DuoBody-PD-L1x4-1BB (GEN1046/BNT311), both of which are now in clinical trials.
Our Innovative Technology in Action
Janssen
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using our DuoBody technology platform. Under this original agreement, Janssen had the right to use the DuoBody technology platform to create panels of bispecific antibodies (up to 10 DuoBody programs) to multiple disease target combinations.
As of December 31, 2022, three DuoBody-based investigational medicines created under this collaboration were in the clinic. Two of these, amivantamab and teclistamab, are the first medicines created using the DuoBody technology platform to receive regulatory approval. In December 2022, Janssen submitted a BLA to the U.S. FDA for the third investigational medicine in active clinical development, talquetamab, for the treatment of patients with relapsed or refractory multiple myeloma. Genmab is entitled to milestone payments as well as royalties on sales of each commercialized DuoBody medicine. Please refer to Note 5.6 of the financial statements for further details regarding the DuoBody collaboration with Janssen.
Novo Nordisk
In August 2015, Genmab entered an agreement to grant Novo Nordisk commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs that would target a disease area outside of cancer therapeutics. After an initial period of exclusivity for both target combinations, Novo Nordisk extended exclusivity of the commercial license for one target combination in 2018, now in clinical development as Mim8. Under the exclusive license agreement, Genmab is entitled to potential milestones and will be entitled to single digit royalties on sales of Mim8, should it receive regulatory approval.
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Collaborations Across the Pharma and Biotech Ecosystem
Immatics
In July 2018, Genmab entered into a research collaboration and exclusive license agreement with Immatics to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. Genmab received an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. Under the terms of the agreement, Genmab paid Immatics an upfront fee of USD 54 million and Immatics is eligible to receive up to USD 550 million in development, regulatory and commercial milestone payments for each antibody product, as well as tiered royalties on net sales.
HexaBody Technology Platform
Creating Differentiated Therapeutics
| ● | Enhanced potency antibody technology platform |
| ● | Broadly applicable technology that builds on natural antibody biology |
| ● | HexaBody-based investigational medicines in clinical development; HexaBody-CD38 (GEN3014) and HexaBody-CD27 (GEN1053/BNT313) |
The HexaBody technology platform is a proprietary Genmab technology that is designed to increase the potency of antibodies. The HexaBody technology platform builds on natural biology and strengthens the natural killing ability of antibodies while retaining regular structure and specificity. The technology allows for the creation of potent therapeutics by inducing antibody hexamer formation (clusters of six antibodies) after binding to their target antigen on the cell surface. We have used the HexaBody technology platform to generate antibodies with enhanced complement-mediated killing, allowing antibodies with limited or absent killing capacity to be transformed into potent, cytotoxic antibodies. In addition to complement-mediated killing, the clustering of membrane receptors by the HexaBody technology platform can lead to subsequent outside-in signaling leading to cell death. The HexaBody technology platform creates opportunities to explore new antibody-based product candidates and repurpose drug candidates unsuccessful in previous clinical trials due to insufficient potency. The HexaBody technology platform is broadly applicable and can be combined with Genmab’s DuoBody technology platform (DuoHexaBody technology platform) as well as other antibody technologies. The technology has the potential to enhance antibody therapeutics for a broad range of applications including cancer and infectious diseases. Genmab is using the HexaBody technology platform for its own antibody programs and the technology is also available for licensing. Two HexaBody-based investigational medicines are currently in clinical development. Genmab entered into an exclusive worldwide license and option agreement with Janssen to develop and commercialize HexaBody-CD38 (GEN3014), a next-generation CD38 monoclonal antibody-based investigational medicine. In 2022, Genmab and BioNTech expanded their global strategic collaboration to include co-development of monospecific antibody candidates leveraging the HexaBody technology. The first antibody in the clinic under this collaboration is HexaBody-CD27 (GEN1053/BNT313).
DuoHexaBody Technology Platform
Combining Dual-Targeting and Enhanced Potency
| ● | Antibody technology that combines DuoBody and HexaBody technology platforms |
| ● | Creates bispecific antibodies with target-mediated enhanced potency |
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| ● | First DuoHexaBody-based investigational medicine in the clinic - DuoHexaBody-CD37 (GEN3009) |
The DuoHexaBody technology platform is a proprietary technology that combines the dual targeting of our DuoBody technology platform with the enhanced potency of our HexaBody technology platform, creating bispecific antibodies with target-mediated enhanced hexamerization. We currently have one investigational medicine created with the DuoHexaBody technology platform in the clinic, DuoHexaBody-CD37 (GEN3009). DuoHexaBody-CD37 is a bispecific antibody that targets two non-overlapping CD37 epitopes. It entered the clinic in 2020 and is currently being investigated in relapsed/refractory B-NHL, including potentially in combination with epcoritamab.
HexElect Technology Platform
Enhancing Selectivity and Potency
| ● | Antibody technology platform inspired by the HexaBody technology platform |
| ● | Combines dual-targeting with enhanced selectivity and potency |
The HexElect antibody technology platform is Genmab’s newest proprietary antibody technology. This technology combines two HexaBody molecules designed to effectively and selectively hit only those cells that express both targets by making the activity of complexes of HexaBody molecules dependent on their binding to two different targets on the same cell. The HexElect technology platform maximizes efficacy while minimizing possible toxicity, potentially leading to more potent and safer investigational medicines.
Corporate Social Responsibility and Sustainability Commitments
We are committed to being a sustainable, socially responsible biotech company. This commitment is anchored in our vision, core purpose and values, focused for impact through our CSR strategy, and lived every day by our team. It is fundamental to the way we do business.
Our Core Purpose and Vision
Our commitment to CSR is anchored in our company’s core purpose “to improve the lives of patients by creating and developing innovative antibody products” and our vision that “by 2030, our KYSO antibody medicines will fundamentally transform the lives of people with cancer and other serious diseases.” Our vision inspires and motivates us. Our unstoppable team is focused on developing innovative and differentiated antibody therapeutics that will improve the lives of patients.
How We Carry Out Our CSR Initiatives
We are committed to complying with all laws, codes, and standards applicable to our business and operations. We also prioritize the well-being and vitality of our teams and actively seek to minimize our impact on the environment. We have high ethical standards and aim to conduct business with companies and within countries that share our ethical commitment including our support for the protection of internationally proclaimed human rights. We strive to conduct clinical trials in markets where a medicine is planned to become available.
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We track trends, benchmark and examine our ESG activities, policies and disclosures to build a sustainable, socially responsible biotech company.
We are committed to transparency and continued improvement of our climate disclosures. To this end, we support the TCFD recommendations as we believe they provide a useful framework to increase transparency on climate-related risks and opportunities. We want to reduce our environmental footprint and aim to provide additional disclosures on climate-related topics in the future as we incorporate the TCFD recommendations into our business. Please refer to “Genmab’s Task Force on Climate-related Financial Disclosures” in this report for more information.
We follow the Sustainability Accounting Standards Board (SASB) framework to disclose critical measurements on ESG activities relevant to our business.
We are committed to ensuring our actions benefit our direct stakeholders (patients, customers, team members, collaboration partners and shareholders) and society as a whole.
To this end, our CSR strategy focuses on four key pillars:
| ● | Science-Driven Health Innovations for Patients |
| ● | Employee Well-Being and Vitality |
| ● | Ethics and Transparency |
| ● | Environmental and Community Sustainability |
As we further execute our CSR strategy and build programs that have an impact on our stakeholders, we will be guided by the following tenets, which support our four CSR pillars:
| ● | We use our world-class knowledge in antibody biology and deep expertise in innovative antibody technology to develop cancer treatments to have a positive impact on society. |
| ● | We care for our employees’ health, well-being, safety and development and promote a collaborative culture that fosters passion for innovation, integrity and respect. |
| ● | We believe that DE&I are fundamental to achieving our vision and are committed to championing a corporate culture that accepts and promotes uniqueness and empowers each team member to bring their authentic self to work in a safe, open and respectful environment. |
| ● | We operate our business with the utmost integrity, seeking to do the right thing in all aspects of our business and integrating compliance, ethics and transparency into our business practices, policies and procedures. |
| ● | We maintain a highly ethical organization, promoting our Code of Conduct to employees and engaging with partners and suppliers committed to the same level of ethics in their operations. |
| ● | We aim to reduce our impact on the environment by refining our processes and incorporating best practices into our operations as we strive to reduce our environmental footprint, minimize waste and decrease use of hazardous material. |
| ● | We monitor and evaluate targets for ESG activities, measure our impact and communicate our progress. |
| ● | We engage with and support the communities in which we operate. |
Our Approach
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Our approach is designed to ensure we carry out our CSR commitments as a core part of our business and in line with international best practice.
| ● | Guided by our vision, purpose and core values |
| ● | Focused on four CSR pillars |
| ● | Underpinned by our commitment to the UNSDGs |
| ● | Supported by the Board of Directors and Executive Management |
| ● | Aligned with ESG priorities and disclosures |