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GENMAB 2022 ANNUAL REPORT
| Management's Review | |
| Our Vision | 2 |
| Chair's Statement | 2 |
| Letter from the CEO | 3 |
| 2022 at a Glance | 4 |
| Consolidated Key Figures | 6 |
| 2023 Outlook | 9 |
| Our Strategy | 11 |
| Who We Are | 13 |
| Business Model | 14 |
| Research and Development Capabilities | 15 |
| Enhancing Commercialization Capabilities to Bring Our Innovations to Patients | 16 |
| Antibody Discovery and Development | 17 |
| Products and Technologies | 17 |
| Corporate Social Responsibility and Sustainability Commitments | 37 |
| Genmab's Task Force on Climate-related Financial Disclosures | 40 |
| Stakeholder Engagement | 44 |
| Human Capital Management | 46 |
| Financial Review | 48 |
| Risk Management | 58 |
| Enterprise Risk Management | 63 |
| Corporate Governance | 64 |
| Board of Directors | 66 |
| Senior Leadership | 69 |
| Shareholders and Share Information | 71 |
| FINANCIAL STATEMENTS FOR THE GENMAB GROUP | 74 |
| FINANCIAL STATEMENTS FOR THE PARENT COMPANY | 131 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE ANNUAL REPORT | 150 |
| INDEPENDENT AUDITOR'S REPORT S | 151 |
| Other information | 155 |
| Glossary | 155 |
| Forward Looking Statement | 157 |
| Contact Information | 158 |
2022 Corporate Responsibility Report (https://ir.genmab.com/static-files/72218610-90a6-4fd3-a76a-d4a7c9c6ef01)
2022 Corporate Governance Report
2022 Compensation Report
Our Corporate Responsibility, Corporate Governance and Compensation Reports for 2022 can be found on our website, Genmab.com.
GENMAB 2022 ANNUAL REPORT
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.
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
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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.
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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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.
Jan van de Winkel, Ph.D.
President & Chief Executive Officer
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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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| (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
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.
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.
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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| Tokyo, JapanTokyo, Japanur Strategy | |||
| 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 I dentify 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-L1x4-1BB 1 & DuoBody-CD40x4-1BB 1 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 Epcoritamab 2 o Expand clinical development program with multiple Phase 3 trials initiated and submission of first BLA (subject to supportive U.S. FDA feedback) Tivdak 3 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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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
In our quest to turn science into medicine, we use these guideposts to transform the future of cancer treatment:
Genmab's Growing Organization and Growing Presence
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Our Key Accomplishments
Each of our achievements stands as evidence of our unyielding determination, including:
At Genmab, we have built a profitable and successful biotech that creates value for our stakeholders.
Our Strengths and Differentiators
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Building a Fully Integrated Biotech Innovation Powerhouse
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
25 ongoing or announced clinical trials with Genmab owned ( 50%) products
448 new full-time jobs created in 2022
12% increase in market capitalization in 2022
Research agreements and collaborations in place across innovation ecosystem of pharma, biotech and academia
Research and Development Capabilities
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
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 caf , 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.