Full Press Release Details
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GENMAB 2021 ANNUAL REPORT
Using Science to Turn Insights into Medicine
To improve the lives of patients with cancer by creating and developing innovative and differentiated antibody medicines. It is our reason for being.
| Management's Review | |
| About Genmab | 3 |
| Who We Are | 3 |
| Timeline | 5 |
| 2021 at a Glance | 6 |
| Our World-class Team | 7 |
| Commercialization | 8 |
| Chair's Statement | 9 |
| Letter from the CEO | 11 |
| Consolidated Key Figures | 13 |
| 2022 Outlook | 15 |
| Business Model | 16 |
| Our Strategy | 18 |
| Our Business | 20 |
| Research and Development Capabilities | 20 |
| Antibody Discovery and Development | 21 |
| Products and Technologies | 23 |
| Risk and Financial Review | 47 |
| Risk Management | 48 |
| Enterprise Risk Management | 54 |
| Financial Review | 56 |
| Shareholders and Share Information | 65 |
| Corporate Responsibility | 68 |
| Corporate Social Responsibility and Sustainability Commitments | 68 |
| Genmab's Task Force on Climate-related Financial Disclosures | 72 |
| Human Capital Management | 76 |
| Stakeholder Engagement | 77 |
| Corporate Governance | 80 |
| Board of Directors | 82 |
| Senior Leadership | 85 |
| FINANCIAL STATEMENTS FOR THE GENMAB GROUP | 87 |
| FINANCIAL STATEMENTS FOR THE PARENT COMPANY | 158 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE ANNUAL REPORT | 179 |
| INDEPENDENT AUDITOR'S REPORT S | 180 |
| Other information | 185 |
| Glossary | 185 |
| Forward Looking Statement | 187 |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 05 |
| Kalvebod Brygge 43 | Page 1/188 | |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
GENMAB 2021 ANNUAL REPORT
Our World-Class Team
At the heart of Genmab is our world-class team of dedicated employees. In this report we will feature four of these team members, one from each of our international sites, who exemplify who we are and how we work.
Vir g Muladi-Szab , HR Operations Associate, Denmark
Aran Labrijn, Director, Antibody Format Discovery Lead, the Netherlands
Ibrahima Soumaoro, Senior Medical Director, Solid Tumors, United States
Mika Takaki, General Manager, Japan
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 05 |
| Kalvebod Brygge 43 | Page 2/188 | |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
GENMAB 2021 ANNUAL REPORT
Genmab is evolving into a fully integrated biotechnology innovation powerhouse, driven by its mission to impact patients' lives.
Our world-class team: Vir g Muladi-Szab , HR Operations Associate, Denmark
I chose to work at Genmab because I feel that here I can truly contribute to an amazing purpose every day; and what a journey it has been! It is inspiring to welcome numerous new colleagues every month and participate in one success after another as one team.
By 2025, our own product has transformed cancer treatment, and we have a pipeline of knock-your-socks-off antibodies.
Genmab's Growing Organization and Growing Presence
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GENMAB 2021 ANNUAL REPORT
In our quest to turn science into medicine, we use these guideposts to transform the future of cancer treatment:
Our Key Accomplishments
Each of our achievements stands as evidence of our unyielding determination, including:
Creators of the DuoBody Technology Platform - Innovative Technology for Bispecific Antibody Therapeutics
Genmab is a scientific leader in antibody technology, inspired by the power of the human immune system to fight disease and with the goal of developing a robust portfolio of investigational medicines with the potential to improve the lives of patients. 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 one medicine approved in both the U.S. and in Europe.
Approved Medicines that Incorporate Genmab's Innovations and Technology
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Differentiated Pipeline
* Tisotumab vedotin co-development with Seagen; epcoritamab and DuoHexaBody-CD37 co-development with AbbVie Inc. (AbbVie); DuoBody-PD-L1x4-1BB and DuoBody-CD40x4-1BB co-development with BioNTech SE (BioNTech); Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen.
Key Events in Genmab's over 20-year Journey
A history of accomplishments rooted in science: From our start in Copenhagen in 1999, our continued commitment to improving patients' lives has given us purpose and drive as we focus on the creation and development of innovative and differentiated antibody products. We strive to achieve this goal by working together as one team and building on our world-class research in antibodies to expand our capabilities beyond the lab.
While we are proud of our past accomplishments for getting us to this point, we keep our eyes and minds focused on what is next. Our history has been powered by a dedication to developing antibody-based therapeutics. It is this same spirit that will guide us into the future.
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1Developed and commercialized by Janssen; 2Co-development Genmab and AbbVie;
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GENMAB 2021 ANNUAL REPORT
2020 Operating Profit impacted by one-time AbbVie upfront payment.
Our World-class Team: Rooted in Science, Inspired by Patients
Inspired by nature: At Genmab's core is an integrated R&D organization that uses its deep understanding of antibodies and the human immune system to develop next-generation antibody technology platforms and a robust pipeline of differentiated antibody-based investigational medicines.
Data-driven decisions: Genmab's teams, including Translational Research and Data Science, work together to create an analytics ecosystem that includes technology, processes and people working together to
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integrate data, allowing for a fast and transparent decision making process. Data-driven decisions ensure that we are able to focus on investigational medicines with the highest potential for meeting patients' needs.
Expanding world-class team: All four state-of-the-art Genmab facilities have grown, from 781 total team members at the end of 2020 to 1,212 at the end of 2021.
Employee well-being: We care for our team members' health, well-being, safety and development and promote a collaborative culture that fosters passion for innovation, integrity and respect. We believe that diversity, equity and inclusion are fundamental to achieving our vision.
Commercialization - the next step in our evolution into an end-to-end biotech: At Genmab we have a thoughtful, focused and deliberate approach to bringing our medicines to patients.
Enhancing Commercialization Capabilities to Bring Our Innovations to Patients
Our 2025 Vision is for Genmab's own medicine to transform cancer treatment. We are becoming an integrated end-to-end biotech innovation powerhouse that discovers, develops and makes next-generation antibody-based medicines available 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 this Vision.
Key to our ability to bring our medicines to patients is commercialization. Over the past few years, we have made tremendous progress building and establishing this important capability, through a disciplined and integrated approach.
At Genmab, commercialization is an integrated approach; everyone doing their part to ensure patients get the most from our next generation of differentiated antibody-based medicines.
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GENMAB 2021 ANNUAL REPORT
I am very proud of how Genmab has continued to evolve over the past year while remaining true to its core purpose of improving the lives of patients through the creation and development of innovative and differentiated antibody-based medicines.
CORE VALUES SUPPORTED BY A STRONG COMPANY CULTURE
Genmab has been able to maintain a focus on its core purpose - to improve the lives of patients - due to the strength of the Company's core values and unique Company culture. Our core values of passion for innovation, determination, integrity and working as one team are fully supported by a culture where patients come first, and our ideas and decisions are rooted in science. Genmab also fosters a culture where colleagues respect and celebrate differences and have the freedom to speak up and empower one another. The approval of Tivdak, a first for Genmab, would not have been possible without our inspiring team members who are dedicated to bringing our core values and culture to life.
COMMITMENT TO CORPORATE GOVERNANCE, SUSTAINABILITY AND THE ENVIRONMENT
Over the past two years we embarked upon a more focused, business-driven corporate social responsibility (CSR) strategy, including a commitment to three United Nations Sustainable Development Goals (SDGs) that are most closely aligned with our business and that our teams can positively impact. We also updated our CSR governance structure.
As Genmab monitors new developments, regulations and industry practices, we carefully consider initiatives that could further enhance our operations as a sustainable and socially responsible biotech. As such, Genmab is committed to help reduce our environmental footprint. Motivated by organizational growth and corresponding stakeholder focus on climate and environment, society and governance (ESG), Genmab evaluated its climate-related risks and opportunities. I'm pleased to report that we have implemented the Task Force on Climate-related Financial Disclosures (TCFD) recommendations, which for the first time are part of this Annual Report. Additionally, Genmab plans to calculate its carbon footprint and set climate ambitions and targets. Genmab acknowledges its responsibility to contribute to the Paris Agreement goals by fulfilling its duty to reduce CO2 emissions. By strategically considering climate-related financial risks and opportunities, Genmab is beginning a journey to further protect long-term value for our operations and build resilience.
As a company we also work diligently to continually improve our guidelines and policies for corporate governance, always taking into account trends in international and domestic requirements and recommendations. This commitment to corporate governance, like our dedication to CSR and the environment, is based on ethics and integrity. Our commitment to corporate governance also impacts our effort to strengthen the confidence that existing and future shareholders, partners, team members and other stakeholders have in Genmab. The role of shareholders and their interaction with Genmab is important, and open and transparent communication is paramount to maintain the confidence of Genmab's shareholders. As such, we continue to conduct regular outreach and engage with our shareholders throughout the year and appreciate their open and candid feedback.
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EXPERIENCED LEADERSHIP
In February of 2021 we further strengthened our Executive Management team with the appointment of Tahamtan Ahmadi as Chief Medical Officer. Dr. Ahmadi joined Genmab in 2017 and prior to his appointment served as Genmab's Senior Vice President, Head of Oncology. In this new role, Dr. Ahmadi leads research, discovery, regulatory and medical activities.
We also saw a change to our Board of Directors as Jonathan Peacock stepped down due to increased responsibilities in connection with his other board commitments. We thank Jonathan for his service to Genmab and are in the process of identifying the best possible candidate to fill this position on Genmab's Board of Directors.
EVOLUTION INTO A FULLY INTEGRATED BIOTECH
In anticipation of the potential regulatory approval and launch of Genmab's first medicine, Genmab took a focused and disciplined approach to further build its teams and strengthen our capabilities across the value chain. In 2021 we took the next step into becoming a fully integrated end-to-end biotech with the launch and co-promotion of our first U.S. FDA approved medicine.
On behalf of the Board of Directors, I would like to thank Genmab's dedicated team members, CEO Jan van de Winkel and the rest of the senior leadership team for their inspiration and extraordinary leadership and all of our shareholders for their continued support.
United Nations Sustainable Development Goals (SDGs)
Genmab embraces its responsibility to society and is pleased to join the effort to progress the United Nations SDGs. In 2021 we continued our commitment to the SDGs most closely aligned with our business: Goals 3, 5 and 8. Refer to Genmab's 2021 Corporate Responsibility report for further details, https://ir.genmab.com/static-files/3a18c1bc-d3ee-401f-a721-c01704b23d98
Goal 3 - Good Health and Well-Being: Ensure healthy lives and promote well-being for all at all ages
Goal 5 - Gender Equality: Achieve gender equality and empower all women and girls
Goal 8 - Decent Work and Economic Growth: Promote sustained, inclusive and sustainable economic growth, full and productive employment and decent work for all
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Over the course of the past few years we have been working to strategically accelerate Genmab's evolution into an end-to-end, fully integrated biotech innovation powerhouse. The initial goal of this growth has been to achieve our ambitious 2025 Vision of having our own cancer treatment on the market and a pipeline of knock-your-socks-off antibodies. I am now extremely proud to say that, with the events of 2021, we have moved closer to realizing our vision and have further strengthened our foundation as we continue to work toward transforming the future of cancer treatment.
Genmab has always been at the forefront of innovation with all of our decisions rooted in cutting-edge science and driven by data. These values are reflected in the status of our proprietary pipeline. Of key importance is the U.S. FDA's accelerated approval of Tivdak, which we are developing with Seagen, making it the first and only antibody-drug conjugate (ADC) approved for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. This approval is a landmark event for Genmab and more importantly, for patients with recurrent or metastatic cervical cancer who have limited treatment options. We and Seagen have a robust development plan for Tivdak including in other solid tumors as well as a randomized Phase 3 study, also announced in 2021, which is intended to confirm Tivdak's benefit in recurrent or metastatic cervical cancer and to support global regulatory applications.
Our investigational medicine in development with AbbVie, epcoritamab, also made strides in 2021 with the first patients dosed in the first Phase 3 study for the bispecific antibody. Epcoritamab data was presented at multiple prestigious conferences and was also published in The Lancet. We are very excited for 2022 as we anticipate not only the start of additional Phase 3 studies but also the filing of the first BLA for epcoritamab, pending supportive feedback from the U.S. FDA.
In 2021 the first patient was dosed with HexaBody-CD38 and an IND was submitted for DuoBody-CD3xB7H4. The first preclinical data for DuoBody-CD3xB7H4 was presented in November at the Society for Immunotherapy of Cancer's (SITC) 36th Anniversary Annual Meeting. Also presented at SITC were expansion cohort data from the Phase 1/2 study of DuoBody-PD-L1x4-1BB in solid tumors and initial dose-escalation data from the Phase 1/2 study of DuoBody-CD40x4-1BB in solid tumors, both of which are in development with BioNTech. These programs advanced as well with the first Phase 2 study of DuoBody-PD-L1x4-1BB and the initiation of multiple expansion cohorts in the Phase 1/2 study of DuoBody-CD40x4-1BB.
validation for genmab's proprietary duobody technology PLATFORM
In addition to our own pipeline, Genmab's innovations were applied in the pipelines of global pharmaceutical and biotechnology companies. In particular, our DuoBody technology platform has powered a variety of bispecific antibody therapies in development. The most advanced of these, amivantamab and teclistamab, are the result of our DuoBody collaboration with Janssen. In 2021 amivantamab was approved, as RYBREVANT, in the U.S., Europe and other markets for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations. These are the first regulatory approvals for a therapy that was created using the DuoBody bispecific technology platform. Subsequently, at the end of 2021 Janssen
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submitted a BLA to the U.S. FDA for teclistamab for the treatment of relapsed or refractory multiple myeloma. Earlier in the year the U.S. FDA granted Janssen Breakthrough Therapy Designation (BTD) for teclistamab in this indication. These events provided further validation for our DuoBody technology platform, which also powers the majority of our own pipeline.
Genmab's Response to the COVID-19 PANDEMIC
The COVID-19 pandemic continued to provide challenges in 2021, though as in 2020 our talented team not only met those challenges but used them as opportunities to help the communities in which we operate. Within Genmab our COVID-19 response team, led by me, developed and implemented a host of precautionary measures to help limit the impact of COVID-19 at our workplaces.
Externally our teams sought out ways to provide assistance to our local communities. Our U.S. office was awarded the 2021 New Good Neighbor Award by NJ Business Magazine in part due to our support of numerous local relief efforts. I am also extremely proud of the way our teams used their specialized expertise to get involved in COVID-19 testing in the Netherlands. In an unprecedented all digital collaboration, Genmab and the Hubrecht Institute, along with later additional partners, developed the STRIP-Robot (Systematic Testing using Robotics and Innovation in Pandemics). This robot, nicknamed "The Beast," rapidly processes large numbers of COVID-19 polymerase chain reaction (PCR) tests, outperforming any other robot known, and at a lower cost per test than other methods. The dramatically increased testing capacity is benefiting our community in the Netherlands both now, during the COVID-19 pandemic, and in any future pandemics. This remarkable achievement was the winner of the prestigious Netherlands Prix Galien Excellence COVID-19 Award. This award reflects both Genmab's position as an innovation powerhouse and our ability to use our expertise to support our communities.
Working to transform the future of cancer treatment
I believe Genmab's success can be judged based on the impact that we have on patients' lives. There are currently five medicines on the market that incorporate our innovations. As we continue to grow and our collaboration partners continue to leverage our technologies, we anticipate that additional medicines based on our science will become available for even more patients. Our near-term vision for the Company may evolve over time as Genmab itself grows and evolves, but our passion for innovating antibody therapeutics with the potential to improve and transform patients' lives will always remain at the heart of Genmab.
As always, none of our achievements over the past year would have been possible without the dedication and talent of our unstoppable world-class team, the support of our 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. Thank you all for your continued support as we look forward to another inspiring year.
Jan van de Winkel, Ph.D.
President & Chief Executive Officer
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GENMAB 2021 ANNUAL REPORT
Consolidated Key Figures
| 2017* | 2018* | 2019 | 2020 | 2021 | |||||
| (DKK million) | |||||||||
| Income Statement | |||||||||
| Revenue | 2,365 | 3,025 | 5,366 | 10,111 | 8,482 | ||||
| Research and development expense | (874) | (1,431) | (2,386) | (3,137) | (4,181) | ||||
| Selling, general and administrative expense | (147) | (214) | (342) | (661) | (1,283) | ||||
| Operating expenses | (1,021) | (1,645) | (2,728) | (3,798) | (5,464) | ||||
| Operating profit | 1,344 | 1,380 | 2,638 | 6,313 | 3,018 | ||||
| Net financial items | (280) | 232 | 221 | (409) | 965 | ||||
| Net profit | 1,104 | 1,472 | 2,166 | 4,758 | 3,008 | ||||
| Balance Sheet | |||||||||
| Marketable securities | 4,075 | 5,573 | 7,419 | 8,819 | 10,381 | ||||
| Cash and cash equivalents | 1,348 | 533 | 3,552 | 7,260 | 8,957 | ||||
| Non-current assets | 544 | 1,028 | 1,183 | 2,352 | 1,891 | ||||
| Assets | 6,603 | 8,461 | 15,144 | 21,143 | 24,627 | ||||
| Shareholders' equity | 6,272 | 8,014 | 14,048 | 19,121 | 22,196 | ||||
| Share capital | 61 | 61 | 65 | 66 | 66 | ||||
| Cash Flow Statement | |||||||||
| Cash flow from operating activities | 1,589 | 1,015 | 1,326 | 6,433 | 2,228 | ||||
| Cash flow from investing activities | (668) | (1,778) | (1,983) | (2,351) | (961) | ||||
| Cash flow from financing activities | 215 | (71) | 3,660 | 71 | (420) | ||||
| Investments in intangible and tangible assets | (89) | (478) | (111) | (307) | (252) | ||||
| Financial Ratios | |||||||||
| Basic net profit per share | 18.14 | 24.03 | 34.40 | 73.00 | 46.00 | ||||
| Diluted net profit per share | 17.77 | 23.73 | 34.03 | 72.21 | 45.54 | ||||
| Year-end share market price | 1,029.00 | 1,067.50 | 1,481.50 | 2,463.00 | 2,630.00 | ||||
| Price / book value | 10.04 | 8.19 | 6.85 | 8.50 | 7.82 | ||||
| Shareholders' equity per share | 102.51 | 130.32 | 216.12 | 289.71 | 336.30 | ||||
| Equity ratio | 95% | 95% | 93% | 90% | 90% | ||||
| Shares outstanding | 61,185,674 | 61,497,571 | 65,074,502 | 65,545,748 | 65,718,456 | ||||
| Average number of employees (FTE)** | 235 | 313 | 471 | 656 | 1,022 | ||||
| Number of employees (FTE) at year-end | 257 | 377 | 548 | 781 | 1,212 |
* Prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 16 as of January 1, 2019. Further, 2017 and prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 15 as of January 1, 2018, and in accordance with the transitional provisions of IFRS 9, comparative figures for 2017 and prior have not been restated.