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 2021


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 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1)

Yes  No 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7)

Yes  No 

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Form S-8 (File No. 333-232693) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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.

nthony

GENMAB A/S

BY:

/s/ Anthony Pagano

Name: Anthony Pagano

Title: Executive Vice President & Chief Financial Officer

DATE: February 23, 2021


EXHIBIT INDEX

O

Exhibit

Description of Exhibit

99.1

Company Announcement Dated February 23, 2021

99.1 (a)

Appendix – Genmab A/S Annual Report 2020

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Extension Labels Linkbase Document

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document


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GENMAB 2020 ANNUAL REPORT

Using Science to Turn Insights into Medicine

Our Purpose

To improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products. It is our reason for being.

Table of Contents

Management’s Review

About Genmab

3

Timeline

5

2020 at a Glance

7

Progress Toward our 2025 Vision

8

Chair’s Statement

9

Letter from the CEO

11

Market Overview

14

2020 Achievements

16

Consolidated Key Figures

18

2021 Outlook

21

Key 2021 Priorities

22

Business Model

22

Our Strategy

25

Our Business

27

Research and Development Capabilities

27

Antibody Discovery and Development

28

Product Pipeline

29

Antibody Technologies

57

Risk Management

65

Financial Review

71

Shareholders and Share Information

80

Environmental, Social, and Governance

83

Commitment to Building a Sustainable and Socially Responsible Biotech

83

Corporate Social Responsibility and Sustainability Commitments

84

Human Capital Management

87

Stakeholder Engagement

88

Corporate Governance

90

Board of Directors

92

Senior Leadership

95

FINANCIAL STATEMENTS FOR THE GENMAB GROUP

98

FINANCIAL STATEMENTS FOR THE PARENT COMPANY

164

DIRECTORS’ AND MANAGEMENT’S STATEMENT ON THE ANNUAL REPORT

187

INDEPENDENT AUDITOR’S REPORT

188

Glossary

193

Forward Looking Statement

194

Contact Information

196

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GENMAB 2020 ANNUAL REPORT

Our Vision

By 2025, our own product has transformed cancer treatment, and we have a pipeline of knock-your-socks-off antibodies

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GENMAB 2020 ANNUAL REPORT

Management’s Review

Genmab is at an inflection point in a transformational journey as the company evolves into a fully integrated biotechnology innovation powerhouse, driven by its mission to impact patients’ lives.

About Genmab

Our Purpose

To improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products. It is our reason for being.

Genmab’s Growing Organization and Growing Presence

Copenhagen, DK
oHQ
oCMC Operations
oClinical Operations
oCorporate Functions
Utrecht, NL
oResearch
oTranslational Research
oAntibody Product Creation
oCorporate Functions
Princeton, USA
oTranslational Research
oDevelopment
oCommercial
oCorporate Functions
Tokyo, JP
oJapan Clinical
oCommercial
oCorporate Functions

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

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GENMAB 2020 ANNUAL REPORT

Determination­ — being the best at what we do
Integrity — we do the right thing
We work as one team and respect each other

Our Key Accomplishments

Each of our achievements stands as evidence of our unyielding determination, including:

Creators of multiple marketed products*
Inventors of four proprietary antibody technologies
Growing multiple proprietary clinical programs
Pioneers of a robust pre-clinical pipeline
World-class team with antibody and R&D expertise
Partnerships with industry leaders and innovators
Solid financial foundation
Building and expanding our capabilities with more than 750 employees across our four international locations

*Products developed and marketed by others incorporating Genmab technology and innovation

Focused on Cancer

Millions of people are diagnosed with cancer each year. Cancer is the second leading cause of death worldwide, with about one in six deaths attributed to cancer. We believe antibody therapies are one of the keys to improving the lives of patients living with cancer. Our antibodies target two main categories of cancer: solid tumors and hematological cancers.

SOLID TUMORS

A solid tumor is an abnormal mass of tissue that usually does not contain any liquid or cysts. Solid tumors may be malignant (cancerous) or benign (non-cancerous). Solid tumors can occur in several places in the body, including the bones, muscles and organs. Sarcomas and carcinomas are examples of solid tumors.

HEMATOLOGICAL CANCERS

Hematological cancers, also called blood cancers, begin in the tissues that form blood, such as the bone marrow, or in the cells of the immune system. The three main types of blood cancers are leukemia, lymphoma and myeloma.

Approved Medicines Created by Genmab*

DARZALEX® (daratumumab)

Approved for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan

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A subcutaneous (SubQ) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX FASPRO® in the U.S., is approved for the treatment of certain multiple myeloma indications in the U.S. and Europe
Marketed by Janssen Biotech Inc. (Janssen)

Kesimpta® (ofatumumab)

Approved in 2020 in the U.S. in relapsing forms of multiple sclerosis (RMS)
Marketed by Novartis International AG (Novartis)

TEPEZZA® (teprotumumab)

Approved in 2020 in the U.S. in thyroid eye disease (TED)
Marketed by Horizon Therapeutics plc (Horizon)

*Products developed and marketed by others incorporating Genmab technology and innovation

Please see pages 28-37 of this Annual Report for detailed indication and safety information

Our Pipeline

Genmab is building a strong pipeline of proprietary antibody products that have the potential to make a real impact on the lives of cancer patients. When we consider which programs to develop, we look for differentiated antibodies that are first-in-class, offer better efficacy than current treatments, or are better tolerated, and have the potential to improve outcomes for cancer patients. In this way we are building a knock-your-socks-off pipeline that offers multiple possibilities for success and the potential to meet our 2025 Vision, while balancing the risks inherent in drug development. We are also working on an extensive portfolio of pre-clinical programs to fuel our pipeline of the future and bring us closer to achieving our 2025 Vision.

7 Genmab-owned ≥50% products in clinical development

3 approved medicines in collaboration

15 product candidates built on Genmab’s innovation in clinical development by other companies

4 proprietary antibody technologies

Timeline

Key Events in Genmab’s 22-year Journey

A history of accomplishments rooted in science: From our start in Copenhagen in 1999, our continued commitment to oncology has given us purpose and a drive to improve the lives of patients with cancer. 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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GENMAB 2020 ANNUAL REPORT

1999 – 2002
oGenmab founded
oCopenhagen IPO
oFirst partnership (Roche)
oOfatumumab program announced
2003 – 2007
oCD38 MAbs generated
oDaratumumab selected
oGSK agreement ofatumumab
2008 – 2011
oArzerra® first U.S. and EU approvals
oDuoBody® platform
oStrategy update
oFirst collaboration with Seattle Genetics (Seagen Inc.)
2012 – 2015
oJanssen DuoBody® Research and License Agreement
oJanssen agreement daratumumab
oHexaBody® platform
oDARZALEX® first U.S approval
oBioNTech SE (BioNTech) agreement
2016 – 2018
oDARZALEX® first EU and Japan approvals
oHexElect® platform
oImmatics Biotechnologies GmbH (Immatics) agreement
2019
oU.S. IPO
oOfatumumab RMS sBLA
oCureVac AG agreement
oHexaBody-CD38 agreement (Janssen)
2020
oAbbVie Inc. (AbbVie) partnership
oFirst Phase 3 epcoritamab1 study announced
oFirst clinical data presented for DuoBody-PD-L1x4-1BB2
oVery favorable topline results in tisotumab vedotin3 Phase 2 innovaTV 204 study
oU.S. approvals for:
Kesimpta®4
DARZALEX FASPRO®5
TEPEZZA®6
oFirst regulatory submissions for product candidate created using DuoBody® technology7

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1Epcoritamab 5:50 partnership with AbbVie; 2DuoBody-PD-L1x4-1BB 50:50 partnership with BioNTech; 3Tisotumab vedotin 50:50 partnership with Seagen; 4 Kesimpta® (ofatumumab) developed by Novartis; 5DARZALEX® (daratumumab) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) developed by Janssen; 6TEPEZZA® (teprotumumab) developed by Horizon; 7Amivantamab, developed by Janssen

2020 at a Glance

Operational

3 approved medicines in collaboration

o

DARZALEX® marketed by Janssen in the U.S., Europe, Japan and multiple other countries

o

Kesimpta® marketed by Novartis in the U.S.

oTEPEZZA® marketed by Horizon in the U.S.
7 proprietary* antibody products in clinical development
oTisotumab vedotin, Epcoritamab, DuoBody-PD-L1x4-1BB (GEN1046), DuoBody-CD40x4-1BB (GEN1042), HexaBody-DR5/DR5 (GEN1029), DuoHexaBody-CD37 (GEN3009) and DuoBody-CD3x5T4 (GEN1044)
4 proprietary technologies

o

DuoBody® platform, HexaBody® platform, DuoHexaBody® platform, HexElect® platform

Dual-listed
oin Denmark and in the U.S.
2 categories of cancer

o

Generate products to treat solid tumors and hematological cancers

~20 pre-clinical projects

o

Extensive partnered and own pre-clinical pipeline

38 INDs

o

Investigational new drug applications (INDs) filed by Genmab and partners, based on Genmab’s innovation, since 1999

Financial

DKK 161B

o

2020 year-end market cap

DKK 10,111M

o

2020 revenue
88% increase versus 2019

DKK 3,798M

o

2020 operating expenses
83% invested in R&D

DKK 16,079M

o

2020 year-end cash position

* Tisotumab vedotin 50:50 partnership with Seagen; Epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4 50:50 partnership with AbbVie; DuoBody-PD-L1x4-1BB and DuoBody-CD40x4-1BB 50:50 partnership with BioNTech, See Consolidated Key Figures, page 18

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Progress Toward Our 2025 Vision

Driving Toward Transformational Success

A point of inflection: With two potential product launches in the coming years, we have never been in a better position to achieve our vision of transforming the lives of cancer patients.

Making our 2025 Vision a reality: Genmab is a world-class antibody innovation powerhouse. We built a strong foundation that includes a robust pipeline built on our proprietary technology, partnerships with innovators and industry leaders and a solid financial base with growing recurring revenues. Genmab’s proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

From clinical to commercial - evolution into a fully integrated biotech: We are building and expanding internal capabilities such as medical affairs, safety, regulatory and data sciences, and are strengthening our R&D teams with key talent. We are also building commercialization excellence as we plan for the first Genmab-labeled medicine. Taken together, we are growing our internal competencies to become an end-to-end biotech.

Broad oncology collaboration with AbbVie: A landmark event in Genmab’s history, this collaboration sets us on a path to accelerate, broaden and maximize the development and commercialization of some of our promising bispecific antibody products, with the ultimate goal to bring new potential therapies much faster to cancer patients.

2020 has further strengthened Genmab’s position as a world-class innovation powerhouse in oncology: We further built up and evolved all areas of our business with now more than 750 employees.

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Chair’s Statement

Dear Shareholder,

In March of this year I was honored to be elected to the position of Chair of Genmab’s Board of Directors. When I first joined the Board, Genmab was a completely different company than it is today. In just three years we have grown our pipeline, our capabilities and our ambitions as a dual-listed company with more than 750 employees across four global sites.

A SUCCESSFUL STRATEGY

This phenomenal growth begins with our core purpose – to improve the lives of patients by creating and developing innovative antibody products. This purpose is linked to a laser-sharp three-pronged strategy: We focus on our core competence – combining our deep insight into antibody biology and disease targets to develop next-generation technologies and identify the best disease targets, leading to the development of differentiated best-in-class and first-in-class antibodies. Some of these innovations have led to medicines that, in turn, have allowed us to build a profitable and successful biotech. Our Vision is that by 2025 this strategy will have provided us with a pipeline of “knock-your-socks-off” antibodies, and our own product will have transformed cancer treatment. We are ahead of schedule in achieving this 2025 Vision and we are confident that our strategy will position us for continued success in the future.

COMMITMENT TO CORPORATE GOVERNANCE AND CSR

The Board of Directors and Genmab’s Senior Leadership are also committed to an integrated Corporate Social Responsibility (CSR) strategy, focusing on employee well-being, ethics and compliance in relation to our research, the environment and business ethics and transparency. In 2020 we embarked upon a more focused, business-driven CSR strategy to steer our efforts and build a foundational CSR program. A key part of this effort included our commitment to three United Nations Sustainable Development Goals (SDGs) that were most closely aligned with our business and that our teams can positively impact. We also benchmarked and examined our environmental, social and governance (ESG) activities, policies and disclosures to build a sustainable organization that meets ESG criteria of relevance to our business operations. We have adopted the Sustainability Accounting Standards Board (SASB) framework and will follow its guidelines to disclose key metrics on ESG activities of relevance to our business operations.

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, is based on ethics and integrity. Our commitment to corporate governance also forms the basis of our effort to strengthen the confidence that existing and future shareholders, partners, employees 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 conduct regular outreach and engage with our shareholders throughout the year.

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GENMAB 2020 ANNUAL REPORT

EXPERIENCED LEADERSHIP

In February of 2020 our long-tenured Chief Financial Officer (CFO), David Eatwell, retired from the company, and we welcomed Anthony Pagano into this position. Mr. Pagano joined Genmab in 2007 and even prior to becoming CFO, he played a key role in Genmab’s success and corporate development.

We further strengthened our Executive Management team in March with the appointment of Anthony Mancini as Chief Operating Officer (COO). Mr. Mancini brought to Genmab, and to this newly created role, strategic and operational leadership as well as a consistent track record of growth across North America, Europe and Australia.

We also welcomed a new member to our Board, Jonathan Peacock. Previously CFO at both Novartis and Amgen, he brings with him extensive experience in corporate finance, strategy and international expansion in the pharmaceutical industry.

In 2020 we continued to successfully execute our strategy to achieve our vision; we are progressing toward launching our own products so that patients with cancer may benefit from our innovations; and we are on a trajectory to become a fully integrated biotech and global oncology leader.

On behalf of the Board, I would like to thank Genmab’s dedicated employees for their commitment to the company during this challenging year, 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.

Sincerely,

Deirdre P. Connelly
Board Chair

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 2020 we reviewed our CSR focus areas and related activities to determine which SDGs were most closely aligned with our business and determined to commit to Goals 3, 5 and 8. See Genmab’s 2020 CSR report for further details

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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GENMAB 2020 ANNUAL REPORT

Letter from the CEO

Dear Shareholder,

The past year was like no other in the history of Genmab. The challenges posed by the global COVID-19 pandemic were extraordinary, but so, too, are Genmab’s passionate and talented employees. I am proud to say that as an organization, we not only rose to meet the global challenges presented by 2020; we made tremendous strides in our evolution into a leading, fully integrated innovation powerhouse, and are closer than ever to achieving our 2025 Vision of transforming cancer treatment.

A TRANSFORMATIONAL YEAR

Genmab has a strong foundation of innovative science and an unparalleled history of repeated success in research and development. Over the course of the past few years, we strategically built on this foundation with the goal of evolving into a fully integrated end-to-end biotech. In 2020 we reached an inflection point in this evolution, created by a series of key events, including our broad oncology collaboration with AbbVie, the opening of our cutting-edge laboratories in the U.S. and the strategic development of our internal capabilities across our global sites — including our latest location in Tokyo, Japan.

By itself, the collaboration with AbbVie is a landmark achievement for Genmab. Both companies share a deep commitment to making a difference for patients, as well as a solid track record of innovation. The agreement put us on a path to accelerate, broaden and maximize the development of some of our promising bispecific antibody products, with the ultimate goal of bringing new potential medicines much faster to cancer patients. Genmab and AbbVie are equal partners, and we are working together to jointly make all strategy, development and commercialization decisions for three Genmab bispecific antibody products – epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4 – as well as potential novel differentiated cancer therapies created under our discovery research collaboration.

Maturing AND EXPANDING Pipeline

A key component of our collaboration with AbbVie is the development of epcoritamab. The first patient was treated with epcoritamab in 2018, and by the end of 2020 we announced the first Phase 3 study. At the beginning of 2021 the first patient was treated in the Phase 3 epcoritamab study and we announced the first Phase 3 study for tisotumab vedotin, our product candidate in development with Seagen. Based on the very favorable Phase 2 innovaTV 204 study results in metastatic cervical cancer, we anticipate, along with Seagen, filing our first Biologics License Application (BLA) for tisotumab vedotin in the first quarter of 2021.

In addition to these later-stage studies, our pipeline expanded in 2020 as we filed two INDs for HexaBody-CD38 and DuoBody-CD3x5T4. Subsequently, DuoBody-CD3x5T4 as well as DuoHexaBody-CD37 progressed into clinical development. We were also extremely pleased to present the first clinical data for DuoBody-PD-L1x4-1BB, one of our programs in development with BioNTech, at the Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary Annual Meeting.

SIGNIFICANT EVOLUTION FOR GENMAB CREATED ANTIBODIES

In addition to the development of our own pipeline, there were great leaps forward with antibodies created by Genmab that are now being developed and marketed by other companies. Chief among these is

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DARZALEX® (daratumumab), developed and commercialized by Janssen. DARZALEX® has already revolutionized the treatment of multiple myeloma, and in 2020 it became the first and only subcutaneously administered CD38 antibody approved in the world. This route of administration significantly reduces treatment burden, as the fixed-dose injection is administered in approximately three to five minutes, offering patients a more convenient treatment experience.

An additional highly anticipated approval in 2020 was that of subcutaneous (SubQ) ofatumumab, as Kesimpta®, in the U.S. for relapsing forms of multiple sclerosis (RMS). Kesimpta®, which is being developed and marketed by Novartis, is the first B-cell therapy that can be self-administered by patients at home, using the Sensoready® autoinjector pen, once monthly after starting therapy.

A third Genmab-created antibody was approved in 2020, with the U.S. Food and Drug Administration (U.S. FDA) approval of TEPEZZA® (teprotumumab), developed and commercialized by Horizon Therapeutics, for thyroid eye disease (TED). TEPEZZA® is the first and only U.S. FDA approved medicine for the treatment of TED, and it has had an incredibly successful launch, despite the impact of COVID-19.

It is also worth noting that Janssen submitted applications for approval for amivantamab in both the U.S. and in Europe in December. These are the first regulatory submissions for a product candidate that was created using Genmab’s proprietary DuoBody® technology platform. Amivantamab is also the first DuoBody® to receive Breakthrough Therapy Designation (BTD) from the U.S. FDA. These events, in addition to the advancement of epcoritamab into Phase 3, underscore the potential of our DuoBody® technology platform to create innovative and differentiated antibody therapeutics.

Genmab’s Response to the COVID-19 PANDEMIC

The COVID-19 pandemic highlighted the importance of science-driven innovation to help solve the world’s most pressing issues and revealed just how interconnected we are as a society. This interdependence reinforces how critically important it is for Genmab to operate with a laser-sharp focus in our response to this unprecedented pandemic.

Genmab continues to closely monitor developments related to the pandemic and follows recommendations from various authorities, including governments and global and local health agencies. Genmab established a COVID-19 response team, which I lead, that closely monitors the evolving situation, develops and implements precautionary measures to help limit the impact of COVID-19 at our workplace and on our communities and ensures business continuity.

Genmab is actively monitoring the potential impact on our key priorities and assessing the situation on an ongoing basis in close contact with clinical trial sites, physicians and contract research organizations (CROs) to evaluate the impact and challenges posed by the COVID-19 situation and manage them accordingly.

DELIVERING ON GENMAB’S COMMITMENT

I believe that 2020 was a turning point for Genmab, with events that turbocharged our evolution into a fully integrated biotech innovation powerhouse. This evolution will allow us to deliver on our commitment to patients and shareholders not only through successful partnered products, but with our own products that may revolutionize cancer treatment. None of our achievements – especially during this incredibly turbulent

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year - would be possible without our dedicated world-class team, the support of our Board of Directors, the patients who participate in our clinical trials, the investigators who help us trailblaze innovations and our shareholders who believe in our 2025 Vision. Thank you all for your continued support as we move into another exciting year.

Sincerely yours,

Jan van de Winkel, Ph.D.

President & Chief Executive Officer

Our Broad Oncology Collaboration with AbbVie

On June 10, 2020, Genmab entered into a broad oncology collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4 and a discovery research collaboration for future differentiated antibody therapeutics for cancer. For epcoritamab, the companies will share commercial responsibilities 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 receive tiered royalties on remaining global sales. For DuoHexaBody-CD37, DuoBody-CD3x5T4 and 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. For the discovery research collaboration, which combines proprietary antibodies from both companies along with Genmab’s DuoBody® technology and AbbVie’s payload and ADC technology, the companies will select and develop up to four additional differentiated next-generation antibody-based product candidates, potentially across both solid tumors and hematological malignancies. Genmab will conduct Phase 1 studies for these programs and AbbVie retains the right to opt-in to program development.

Under the terms of the agreement, Genmab received a USD 750 million upfront payment from AbbVie with the potential for Genmab to receive up to USD 3.15 billion in additional development, regulatory and sales milestone payments for all programs, 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 share in pre-tax profits from the sale of products on a 50:50 basis. Included in these potential milestones are up to USD 1.15 billion in payments related to clinical development and commercial success across the three existing bispecific antibody programs. In addition, and also included in these potential milestones, if all four next-generation antibody product candidates developed as a 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, DuoHexaBody-CD37 and DuoBody-CD3x5T4, while Genmab will be responsible for 100% of the costs for the discovery research programs up to opt-in.

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Market Overview

Oncology: A Critical and Growing Market

Each year, millions of people are diagnosed with cancer, the second leading cause of death worldwide.1 One in six deaths is cancer-related. The time to transform how cancer is treated is now.

What is Driving Change?

Global innovation in oncology is rapidly accelerating within an ever-evolving and progressing biopharmaceutical industry. An increase in the development and availability of monoclonal antibodies (MAbs) has fueled another wave of innovation, which includes multi-specific drugs that have the potential to reframe how we think about targeted therapies. This focus on specific molecular therapies, coupled with technological and diagnostic advancements, has provided important tools to offer greater promise of personalized therapies. In addition, continued commitment to data science, predictive analytics and translational medicine will help biotech companies like ours develop smarter, more efficacious cancer treatments. Through partnerships and collaborations with academia, pharma and other biotechs, we are seeking ways to accelerate development of cancer therapies via robust clinical development programs and more efficient clinical trials that may rapidly provide activity signals and lead to breakthrough therapies that may reach patients.

What is the Outlook?

By 2040, the global burden of cancer is expected to grow to more than 27 million new cases and more than 16 million deaths due to the growth and aging of the population.2

Improved understanding and treatment of cancer, coupled with innovation and collaboration, will continue to have a meaningful and transformative potential for patient outcomes. As science continues to unravel the interplay between cancer and anticancer immunity, increased investment in immuno-oncology research has yielded promising therapies poised to revolutionize cancer treatment. In addition, as competition for key oncology targets has intensified, development timelines have accelerated significantly, potentially opening up quicker paths to regulatory submissions and approvals, and eventually to patients who need new options.

At Genmab, we believe in the power of antibody therapeutics to disrupt traditional approaches to treating cancer. In fact, MAbs have experienced explosive growth to become some of the most successful and widely used treatments in oncology, with bispecific antibodies specifically emerging as promising candidates for differentiated therapies.3 Our pipeline’s focus on these unique multi-specific antibody products places us in an excellent position to transform cancer treatment. Continued growth of antibody therapeutics in the coming years is expected to be a significant growth driver in the oncology market.

Genmab’s Position in Oncology

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Genmab is a biotechnology innovation powerhouse, pioneering the discovery, development and future commercialization of a new frontier of transformative antibody cancer medicines. Through our 22-year history, we have been unyielding in our efforts to better understand cancer and its impact on patients’ lives. To do so, we have had a laser-sharp focus on harnessing the power of human antibodies to develop differentiated cancer therapeutics.

We turn our deep understanding of antibody biology into inventive technology platforms, including DuoBody®, HexaBody®, DuoHexaBody® and HexElect® that fuel a transformative pipeline. Through our data-driven translational approach, we are continuing to uncover more about novel cancer pathways, biomarkers and targets that drive our research forward to transform the future of cancer treatment.

Our strong pipeline includes a number of potentially best-in-class or first-in-class product candidates, including two products in Phase 3 clinical development for patients with high unmet medical needs. We are excited by the prospect of potentially launching two of our own product candidates in the coming years with a focus on the U.S. and Japan.

We also have a depth and breadth of experience forging effective partnerships to bring therapies to patients faster. Our successful track record of over 20 key partnerships include three Genmab-created and approved antibody therapeutics commercialized by our partners. Our innovation- and collaboration-based culture has always been part of our DNA and is a major factor of our overall success.

We do not take our responsibility to help more patients through science lightly. As we look to the future of cancer care, we are working to identify the best disease targets, discover unique best- or first-in-class antibodies and develop next-generation antibody product candidates. As we work toward our vision of becoming a fully integrated biotechnology company, we will continue to strive to improve the lives of patients with cancer.

What Markets do We Operate In?

Our global footprint includes our headquarters in Copenhagen and world-class research and development facilities in Utrecht, Princeton and Tokyo. We are also building commercialization excellence as we plan for the first Genmab-labeled medicine, focusing our efforts, initially, on two priority markets, the U.S. and Japan. Through science, innovation and drug discovery and development, we are determined to positively impact the lives of people with cancer throughout the world.

1 https://www.who.int/health-topics/cancer#tab=tab_1
2“Global Cancer Facts & Figures 4th Edition.” Global Cancer Facts & Figures, American Cancer Society, www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-4th-edition.pdf.
3Research and Markets, “Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030” published January 2020.

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2020 Achievements

Priority

Achieved

Targeted Milestone

Genmab proprietary* products

»
Tisotumab vedotin1 - Phase 2 innovaTV 204 safety and efficacy analysis in recurrent/metastatic cervical cancer and engage U.S. FDA for BLA submission subject to trial results

»
Tisotumab vedotin - data on other solid tumor types

»
Enapotamab vedotin – data to support late-stage development

»
Epcoritamab (DuoBody-CD3xCD20)2 Phase 1/2 – decision on recommended Phase 2 dose and initiate expansion cohorts

»
HexaBody-DR5/DR5 Phase 1/2 - advance dose escalation

»
DuoBody-PD-L1x4-1BB3 Phase 1/2 – initiate expansion cohorts

»
DuoBody-PD-L1x4-1BB initial data in H2 2020

»
File INDs and/or CTAs for 2 new products

Daratumumab4

»
U.S. FDA and EMA decision on Phase 3 COLUMBA multiple myeloma SubQ submission
»
sBLA and MAA Submission Phase 3 ANDROMEDA amyloidosis
»
sBLA and MAA submission Phase 3 APOLLO multiple myeloma

Ofatumumab5

»
U.S. FDA decision on regulatory dossier submission in multiple sclerosis

Teprotumumab6

»
U.S. FDA decision on Phase 3 OPTIC active thyroid eye disease submission

*Certain product candidates in development with partners, as noted

Now anticipated in 2021

Announced on November 24, 2020 that development would not advance

1. 50:50 partnership w/ Seagen; 2. 50:50 partnership w/ AbbVie; 3. 50:50 partnership w/ BioNTech; 4. In dev. by Janssen; 5. In dev. by Novartis; 6. In dev. by Horizon

Financial Performance

·

Revenue was DKK 10,111 million in 2020 compared to DKK 5,366 million in 2019. The increase of DKK 4,745 million, or 88%, was primarily driven by the upfront payment from AbbVie pursuant to our new collaboration announced in June and higher DARZALEX® royalties.

·

Operating expenses increased by DKK 1,070 million, or 39%, from DKK 2,728 million in 2019 to DKK 3,798 million in 2020 driven by the advancement of epcoritamab (DuoBody-CD3xCD20) and

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DuoBody-PD-L1x4-1BB, additional investments in our product pipeline and the increase in new employees to support the expansion of our product pipeline.

·

Operating result was DKK 6,313 million in 2020 compared to DKK 2,638 million in 2019. The improvement of DKK 3,675 million, or 139%, was driven by higher revenue, which was partly offset by increased operating expenses.

·

2020 year-end cash position of DKK 16,079 million, an increase of DKK 5,108 million, or 47%, from DKK 10,971 million as of December 31, 2019.

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Consolidated Key Figures

2016*

2017*

2018*

2019

2020

(DKK million)

Income Statement

Revenue

1,816

2,365

3,025

5,366

10,111

Research and development expense

(661)

(874)

(1,431)

(2,386)

(3,137)

General and administrative expense

(102)

(147)

(214)

(342)

(661)

Operating expenses

(763)

(1,021)

(1,645)

(2,728)

(3,798)

Operating result

1,053

1,344

1,380

2,638

6,313

Net financial items

77

(280)

232

221

(409)

Net result

1,187

1,104

1,472

2,166

4,758

Balance Sheet

Cash position**

3,922

5,423

6,106

10,971

16,079

Non-current assets

341

544

1,028

1,183

2,352

Assets

5,238

6,603

8,461

15,144

21,143

Shareholders' equity

4,827

6,272

8,014

14,048

19,121

Share capital

60

61

61

65

66

Cash Flow Statement

Cash flow from operating activities

328

1,589

1,015

1,326

6,433

Cash flow from investing activities

(1,015)

(668)

(1,778)

(1,983)

(2,351)

Cash flow from financing activities

91

215

(71)

3,660

71

Cash and cash equivalents

307

1,348

533

3,552

7,260

Cash position increase

429

1,501

683

4,865

5,108

Investments in intangible and tangible assets

(33)

(89)

(478)

(111)

(307)

Financial Ratios

Basic net result per share

19.83

18.14

24.03

34.40

73.00

Diluted net result per share

19.22

17.77

23.73

34.03

72.21

Year-end share market price

1,173.00

1,029.00

1,067.50

1,481.50

2,463.00

Price / book value

14.67

10.04

8.19

6.85

8.50

Shareholders' equity per share

79.98

102.51

130.32

216.12

289.71

Equity ratio

92%

95%

95%

93%

90%

Average number of employees (FTE)***

196

235

313

471

656

Number of employees (FTE) at year-end

205

257

377

548

781

*     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.

**   Cash, cash equivalents and marketable securities

***  Full-time equivalent

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2021 Outlook

(DKK million)

2021 Guidance

2020 Actual Result

Revenue

6,800 - 7,500

10,111

Operating expenses

(5,500) - (5,800)

(3,798)

Operating result

1,000 - 2,000

6,313

Revenue

We expect our 2021 revenue to be in the range of DKK 6,800 – 7,500 million, compared to DKK 10,111 million in 2020. Our revenue in 2020 was significantly impacted by the AbbVie collaboration and included DKK 4,398 million related to the portion of the upfront payment that was allocated to the license grants and recognized as revenue in 2020.

Our projected revenue for 2021 primarily consists of DARZALEX® royalties of DKK 4,900 – 5,300 million. Such royalties are based on estimated DARZALEX® 2021 net sales of USD 5.2 – 5.6 billion compared to actual net sales in 2020 of approximately USD 4.2 billion. Janssen has started reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme in connection with subcutaneous sales beginning in the second quarter of 2020. Given the ongoing arbitration, Genmab has reflected this as a reduction to estimated 2021 revenue. The remainder of our revenue consists of royalties from TEPEZZA® and Kesimpta®, reimbursement revenue, milestones for epcoritamab under our AbbVie collaboration, and other milestones.

Operating Expenses

We anticipate our 2021 operating expenses to be in the range of DKK 5,500 – 5,800 million, compared to DKK 3,798 million in 2020. The increase is driven by the advancement of our clinical programs, continued investment in research and development, as well as building our commercial organization and infrastructure.

Operating Result

We expect our operating result to be in the range of DKK 1,000 – 2,000 million in 2021, compared to DKK 6,313 million in 2020.

Outlook: Risks and Assumptions

In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to, the achievement of certain milestones associated with our collaboration agreements; our ongoing binding arbitration of two matters under our license agreement with Janssen relating to daratumumab; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX®, Kesimpta® and TEPEZZA® net sales and royalties paid to Genmab; and currency exchange rates (the 2021 guidance assumes a USD/DKK exchange rate of 6.0). The financial guidance assumes that no significant agreements are entered into during 2021 that could materially affect the results. Additionally, the COVID-19 pandemic could potentially materially adversely impact our business and financial performance, including our clinical trials, projected regulatory approval timelines, supply chain and revenues, and cause our actual results to differ materially from our 2021 Guidance and Key 2021 Priorities in this annual report.

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The global outbreak of COVID-19 may have long-term impacts on the development, regulatory approval and commercialization of our product candidates and on net sales of our approved products by our collaboration partners. The longer the pandemic continues, the more severe the impacts described below will be on our business. The extent, length and consequences of the pandemic are uncertain and impossible to predict. Genmab has established a COVID-19 response team, led by the CEO, that closely monitors the evolving situation, develops and implements precautionary measures to help limit the impact of COVID-19 at our workplace and on our communities and ensures business continuity. Genmab is also actively monitoring the potential impact on our Key 2021 Priorities and assessing the situation on an ongoing basis in close contact with clinical trial sites, physicians and contract research organizations to evaluate the impact and challenges posed by the COVID-19 situation and manage them accordingly. The full extent and nature of the impact of the COVID-19 pandemic and related containment measures on our business and financial performance is uncertain as the situation continues to develop. The factors discussed above, as well as other factors which are currently unforeseeable, may result in further and other unforeseen material adverse impacts on our business and financial performance, including on the net sales of DARZALEX®, Kesimpta® and TEPEZZA®, by our partners and on our royalty and milestone revenue therefrom.

Key 2021 Priorities

Priority

Targeted Milestone

Bring our own medicines to patients

·

Tisotumab vedotin1 – U.S. FDA decision on BLA and progress to market

·

Tisotumab vedotin – JNDA submission in cervical cancer

·

Epcoritamab2 - acceleration and maximization of development program by advancing expansion cohort and initiating additional Phase 3 trials

Build world-class differentiated product pipeline

·

DuoBody-PD-L1x4-1BB3 – expansion cohort data

·

DuoBody-CD40x4-1BB3 – dose escalation data

Tisotumab vedotin – data in other tumor indication

·

Earlier-stage products – progress and expand innovative product pipeline

Become leading integrated innovation powerhouse

·

Operational commercialization model in U.S. and Japan

Further strengthen solid financial foundation

1. 50:50 partnership w/ Seagen; 2. 50:50 partnership w/ AbbVie; 3. 50:50 partnership w/ BioNTech

Business Model

At Genmab we have built a profitable and successful biotech that creates value for all our stakeholders

Our Strengths and Differentiators

World-class antibody biology knowledge and deep insight into disease targets

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Discovery and development engine with proprietary technologies that allow us to build a world-class pipeline
In-house expertise with solid track record of building successful strategic partnerships
Robust pipeline of potential best-in-class and first-in-class therapies
Experienced, diverse management team

Building a Fully Integrated Biotech Powerhouse

Team: Flexible and adaptive infrastructure
Translational research and data sciences: key to accelerating development and ensuring the right therapies get to the right patients
Collaboration across ecosystem of pharma, biotech and academia to drive our business forward
Strong financials with growing recurring revenues and focused investment

Research: track record of success and investing for tomorrow

Development: Scaling up capabilities to expand from early- to late-stage

Commercialization: next step in our evolution

Enabling functions: support growth and manage risk

The value we create for stakeholders

Patients

230 ongoing clinical trials with Genmab-created antibodies

Our people

>220 number of new full-time jobs created in 2020; among 50 EU companies in Goldman Sachs Womenomics Index

Investors

67% increase in market capitalization in 2020

Collaborations:

8 DuoBody® products in clinical development by other companies

Our Purpose

To improve the lives of patients with cancer by creating and developing innovative and differentiated antibody products

Our Vision

By 2025, our own product has transformed cancer treatment, and we have a pipeline of knock-your-socks-off antibodies

Our Values

Passion for innovation

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Determination—being the best at what we do

Integrity—we do the right thing

We work as one team and respect each other

Where We Operate

Copenhagen, Denmark

Utrecht, the Netherlands

Princeton, United States

Tokyo, Japan

Our Strategy

Focus on core competence

Turn science into medicine

Build a profitable and successful biotech

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Our Strategy

Our Strategy

Business Strategy

Progress in 2020

Priorities for 2021

Link to Risk

Focus on core competence

Identify the best disease targets
Develop unique first-in-class or best-in-class antibodies
Develop next-generation technologies
Epcoritamab1 Phase 1/2 – decision on recommended Phase 2 dose and initiate expansion cohorts
DuoBody-PD-L1x4-1BB2 Phase 1/2 – initiate expansion cohorts
DuoBody-PD-L1x4-1BB initial data in H2 2020
File INDs and/or CTAs for 2 new products
DuoBody-PD-L1x4-1BB – expansion cohort data
DuoBody-CD40x4-1BB – dose escalation data
Tisotumab vedotin – data in other tumor indication
Earlier-stage products – progress and expand innovative product pipeline

See “Risk related to Business” on page 60

Turn science into medicine

Create differentiated antibody therapeutics with significant commercial potential

Daratumumab3

U.S. FDA and EMA decision on Phase 3 COLUMBA multiple myeloma SubQ submissions
sBLA and MAA Submission Phase 3 ANDROMEDA amyloidosis
sBLA and MAA submission Phase 3 APOLLO multiple myeloma

Ofatumumab4

U.S. FDA decision on regulatory dossier submission in multiple sclerosis

Teprotumumab5

U.S. FDA decision on Phase 3 OPTIC active thyroid eye disease submission
Tisotumab vedotin – U.S. FDA decision on BLA and progress to market
Tisotumab vedotin – JNDA submission in cervical cancer
Epcoritamab - acceleration and maximization of development program by advancing expansion cohort and initiating additional Phase 3 trials

See “Risk related to Strategic collaborations” on page 61

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Build a profitable and successful biotech

Maintain a flexible and capital-efficient model
Maximize relationships with partners
Retain ownership of select products
Tisotumab vedotin6 - Phase 2 innovaTV 204 safety and efficacy analysis in recurrent/metastatic cervical cancer and engage U.S. FDA for BLA submission subject to trial results
AbbVie collaboration
8th year of profitability with recurring revenue growth and focused investment in pipeline and capabilities
Operational commercialization model in U.S. and Japan
Further strengthen solid financial foundation

See “Risk related to Finances” on page 62

CSR Strategy

Genmab is committed to our business-driven CSR strategy, which focuses on four main areas:

1.
Employee well-being, including health, safety and development
2.
Ethics and compliance in relation to pre-clinical and clinical studies
3.
Business ethics and transparency
4.
Environment, including waste management and recycling

Progress in 2020

Defined more focused, business-driven CSR strategy to steer our efforts. Commitment to three United Nations SDGs

Determining the key ESG-related activities and disclosures important to our business,

Launched our first sustainability working group

Priorities for 2021

Continue to advance Genmab’s CSR strategy and activities focused on four main areas

Further integrate ESG into our strategic planning and risk management processes, monitor ESG matters of relevance to our business operations and establish clear goals to measure our performance

Use SASB framework and follow its guidelines to disclose critical measurements

Please refer to the risks included in Genmab’s 2020 CSR report.

1. 50:50 partnership w/ AbbVie; 2. 50:50 partnership w/ BioNTech; 3. In dev. by Janssen; 4. In dev. by Novartis; 5. In dev. by Horizon 6. 50:50 partnership w/ Seagen

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Our Business

Our world-class insight into antibody biology and disease targets, differentiated proprietary antibody technologies and strong collaborations position us well to create novel first-in-class or best-in-class therapeutic candidates.

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 exploit this expertise to create and develop differentiated antibody product candidates. We utilize a sophisticated and highly automated process to efficiently generate, select, produce and evaluate human antibody product candidates. Our research and development teams have established a fully integrated R&D enterprise and streamlined process to coordinate the activities of 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 antibody products with the capacity for improving patients’ lives. Our antibody expertise has also enabled us to create our cutting-edge technology platforms: DuoBody®, HexaBody®, DuoHexaBody® and HexElect®. We are also transforming ourselves by 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 discover new targets and biomarkers and bolster our in-depth translational medicine laboratory capabilities. All of this is in an effort to get the right antibody product to the right patient at the right dose.

Genmab’s discovery and pre-clinical research is conducted at its Research and Development Center in Utrecht, the Netherlands. The building is one of the first BREEAM (Building Research Establishment Environmental Assessment Method) Excellent laboratory buildings in the Netherlands. The R&D Center houses state-of-the-art laboratories including an advanced robotics lab, a modern auditorium, science café, and innovative brainstorm and meeting rooms. Located in close proximity to other life science companies and a world-class university, this space provides a bright, open and collaborative atmosphere to enable the Genmab team to continue to innovate and find new ways to help cancer patients. In order to accommodate Genmab’s growth, we also signed an agreement to occupy the first and second floors of the new “Accelerator” building, a multi-tenant building that will be connected directly to the R&D Center and that will be built to achieve the same BREEAM Excellent high sustainability standard. Completion of this building, which will contain both offices and laboratories, is expected in early 2022.

In addition, Genmab opened its new U.S. facility in 2020. This new space, which was modeled on the open and collaborative spirit of the R&D Center in Utrecht, includes both offices and laboratories. The opening of the Princeton translational research laboratories allows Genmab to expand its translational pre-clinical and clinical drug development research expertise and is part of the strategic growth of the company.

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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.

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Products and Technologies

Product Pipeline

At the end of 2020, Genmab’s proprietary pipeline of product candidates, where Genmab owns at least 50% of the program, consisted of seven clinical-stage antibodies*. Combined with product candidates being developed by other companies that were either created by Genmab or that incorporate Genmab’s innovation, our pipeline consists of over 20 antibodies in clinical development, including three approved products. In addition to the antibodies in clinical development, Genmab’s pipeline includes around 20 in-house and partnered pre-clinical programs. An overview of the development status of each of our clinical-stage product candidates is provided in the following sections. Detailed descriptions of dosing, efficacy and safety data from certain clinical trials have been disclosed in company announcements and media releases published via the Nasdaq Copenhagen stock exchange. Additional information is available on Genmab’s website, www.genmab.com.

*On November 24, 2020, Genmab announced that it would not advance the development of the clinical-stage antibody drug conjugate, enapotamab vedotin. While enapotamab vedotin showed some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Approved Medicines Created by Genmab

DARZALEX® / DARZALEX FASPRO® (daratumumab / daratumumab and hyaluronidase-fihj, Janssen)

Kesimpta® (ofatumumab, Novartis)

TEPEZZA® (teprotumumab, Horizon)

Proprietary Products in Development (≥50% Genmab ownership)

Tisotumab vedotin

Epcoritamab

DuoBody-PD-L1x4-1BB

DuoBody-CD40x4-1BB

HexaBody-DR5/DR5

DuoHexaBody-CD37

DuoBody-CD3x5T4

Programs Incorporating Genmab’s Innovation

Amivantamab (Janssen)

Teclistamab (Janssen)

Mim8 (Novo Nordisk)

Camidanlumab tesirine (ADC Therapeutics)

PRV-015 (Provention Bio)

HuMax-IL8 (BMS)

Talquetamab (Janssen)
JNJ-70218902 (Janssen)

JNJ-63709178 (Janssen)

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JNJ-67571244 (Janssen)

JNJ-63898081 (Janssen)

Lu AF82422 (Lundbeck)

Pre-clinical Programs

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Approved Medicines Created by Genmab1

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1Products developed and marketed by others incorporating Genmab technology and innovation

2See local country prescribing information for precise indications

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Proprietary3 Products in Development

Table

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3Certain product candidates in development with partners, as noted
4Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen

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Programs Incorporating Genmab’s Innovation5

Table

Description automatically generated

5Products under development by a third-party incorporating Genmab technology and innovation

Approved Medicines Created by Genmab

Products developed and marketed by others incorporating Genmab technology and innovation

DARZALEX® (daratumumab)

Redefining the Treatment of Multiple Myeloma

First-in-class human CD38 monoclonal antibody
Intravenous (IV) formulation approved in combination with other therapies for frontline and for relapsed/refractory multiple myeloma in territories including the U.S., Europe and Japan and as monotherapy for heavily pretreated or double-refractory multiple myeloma in territories including the U.S. and Europe
First and only SubQ CD38-directed antibody approved in the U.S. and Europe for the treatment of certain multiple myeloma indications, known as DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S.

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Developed by Janssen under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab
2020 net sales of DARZALEX® by Janssen were USD 4,190 million

DARZALEX® (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 light-chain (AL) amyloidosis plasma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). Genmab used technology licensed from Medarex to generate the CD38 antibody forming part of daratumumab. Daratumumab is being developed by Janssen under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab (see Daratumumab Collaboration with Janssen Biotech, Inc. section for more information). DARZALEX® (daratumumab) intravenous infusion and DARZALEX® SubQ administration (daratumumab and hyaluronidase-fihj) are approved in certain territories for the treatment of adult patients with certain multiple myeloma indications as indicated on the following page.

As of December 31, 2020, DARZALEX® (daratumumab) is indicated for the treatment of adult patients:

Jurisdiction

Approval

Key Underlying
Clinical Trial(s)

United States: IV infusion

Relapsed / Refractory MM

November 2015

Monotherapy for patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent

SIRIUS (MMY2002)

November 2016

In combination with Rd or Vd, for patients who have received at least one prior therapy

CASTOR (MMY3004); POLLUX (MMY3003)

June 2017

In combination with Pd for patients who have received at least two prior therapies, including lenalidomide and a PI

EQUULEUS (MMY1001)

August 2020

In combination with Kd for patients with RRMM who have received one to three previous lines of therapy

CANDOR

EQUULEUS (MMY1001)

Frontline MM

May 2018

In combination with VMP for newly diagnosed patients who are ineligible for ASCT

ALCYONE (MMY3007)

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June 2019

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

MAIA (MMY3008)

September 2019

In combination with VTd for newly diagnosed patients who are eligible for ASCT

CASSIOPEIA (MMY3006)

Split Dosing Regimen

February 2019

Option to split first infusion over two consecutive days

EQUULEUS (MMY1001)

European Union: IV infusion or SubQ administration

Relapsed / Refractory MM

IV: April 2016

SubQ: June 2020

Monotherapy for patients whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy

IV: SIRIUS (MMY2002)

SubQ: COLUMBA/

PLEIADES

IV: February 2017

SubQ: June 2020

In combination with Rd or Vd for patients who have received at least one prior therapy

IV: CASTOR (MMY3004); POLLUX (MMY3003)

SubQ: COLUMBA/

PLEIADES

Frontline MM

IV: July 2018

SubQ: June 2020

In combination with VMP for newly diagnosed patients who are ineligible for ASCT

IV: ALCYONE (MMY3007)

SubQ: COLUMBA/

PLEIADES

IV: November 2019

SubQ: June 2020

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

IV: MAIA (MMY3008)

SubQ: COLUMBA/

PLEIADES

IV: January 2020

SubQ: June 2020

In combination with VTd for newly diagnosed patients who are eligible for ASCT

IV: CASSIOPEIA (MMY3006)

SubQ: COLUMBA/

PLEIADES

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Split Dosing Regimen

December 2018

Option to split first infusion over two consecutive days

EQUULEUS (MMY1001)

Japan: IV Infusion

Relapsed / Refractory MM

September 2017

In combination with Rd or Vd

CASTOR (MMY3004); POLLUX (MMY3003)

November 2020

In combination with Kd for patients with RRMM who have received one to three previous lines of therapy

CANDOR

Frontline MM

August 2019

In combination with VMP for newly diagnosed patients ineligible for ASCT

ALCYONE (MMY3007)

December 2019

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

MAIA (MMY3008)

As of December 31, 2020, DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) SubQ administration is indicated for the treatment of adult patients in the U.S.:

Approval

Key Underlying Clinical Trial(s)

United States: SubQ Administration

Relapsed / Refractory MM

May 2020

In combination with Rd or Vd, for patients who have received at least one prior therapy

Monotherapy for patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent

COLUMBA/

PLEIADES

Frontline MM

May 2020

In combination with VMP for newly diagnosed patients who are ineligible for ASCT

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

COLUMBA/

PLEIADES

PI = proteasome inhibitor; Rd = lenalidomide and dexamethasone; Vd = bortezomib and dexamethasone; VMP = bortezomib, melphalan and prednisone; VTd = bortezomib, thalidomide and dexamethasone; ASCT = autologous stem cell transplant; Pd = pomalidomide and dexamethasone; Kd = carfilzomib and dexamethasone

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A comprehensive clinical development program for daratumumab is ongoing, including studies in AL amyloidosis and smoldering, maintenance and frontline multiple myeloma settings. Daratumumab has received two BTDs from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

Safety Information for DARZALEX®

The warnings and precautions for DARZALEX® (daratumumab) include infusion reactions, interference with serological testing and interference with determination of complete response. The most frequently reported adverse reactions (incidence ≥20%) in clinical trials were: infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy and upper respiratory tract infection.

Safety Information for DARZALEX FASPRO®
The warnings and precautions for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) include hypersensitivity and other administration reactions, neutropenia, thrombocytopenia, embryo-fetal toxicity and interference with cross-matching and red blood cell antibody screening. The most frequently reported adverse reaction (incidence ≥20%) in clinical trials with DARZALEX FASPRO® monotherapy was upper respiratory tracts infection.

Please consult the full U.S. Prescribing Information and the full European Summary of Product Characteristics for DARZALEX® (daratumumab) and the full U.S. Prescribing Information for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for all the labeled safety information.

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About Multiple Myeloma

A blood cancer that occurs when malignant plasma cells grow uncontrollably in bone marrow and for which there is no cure at present

·

53.9% 5-year survival rate in the U.S.1

·

32,270 people estimated newly diagnosed and 12,830 estimated to have died from multiple myeloma in the U.S. in 20202

·

176,404 people estimated diagnosed and 117,077 estimated to have died from multiple myeloma worldwide in 20203

1 Surveillance, Epidemiology and End Results Program (SEER). Cancer Stat Facts: Myeloma. Available at http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed December 2020. 2 American Cancer Society. Available at https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html Accessed December 2020. 3 World Health Organization. Available at https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf Accessed December 2020.

About Amyloidosis

A very rare disease caused by the buildup of an abnormal protein called amyloid, which is made by plasma cells, in the tissues or organs

·

4,000 approximate number of new cases diagnosed annually, making AL amyloidosis the most common type of amyloidosis in the U.S.1

·

12-15% of multiple myeloma patients develop light chain (AL) amyloidosis2

1 Cancer.net https://www.cancer.net/cancer-types/amyloidosis/statistics Accessed December 2020.

2 Cancer.Net Guide to Amyloidosis. https://www.cancer.net/cancer-types/amyloidosis/risk-factors Accessed December 2020.

FOURTH QUARTER UPDATES

November: Janssen submitted regulatory applications to the U.S. FDA, the European Medicines Agency (EMA) and the Ministry of Health, Labour and Welfare (MHLW) in Japan seeking approval of the daratumumab SubQ formulation, known as DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® SC in the EU, in combination with cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients newly diagnosed with AL amyloidosis. The U.S. FDA is reviewing the sBLA for this indication under their Real-Time Oncology Review (RTOR) pilot program and Project Orbis. The submissions were based on positive topline data from the Phase 3 ANDROMEDA (NCT03201965) study, which were announced in May 2020.
November: Janssen submitted regulatory applications to the U.S. FDA and EMA seeking approval of the daratumumab SubQ formulation, known as DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® SC in the EU, with pomalidomide and dexamethasone (Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The submissions were based on positive results from the Phase 3 APOLLO study (NCT03180736), which were announced in July 2020.
October: Genmab announced that at a pre-planned interim analysis, the second part of the Phase 3 CASSIOPEIA study (NCT02541383) of daratumumab as maintenance treatment for patients with

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newly diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT), met the primary endpoint of progression-free survival (PFS) (Hazard Ratio (HR) = 0.53 (95% CI 0.42 – 0.68), p < 0.0001), resulting in a 47% reduction in the risk of progression or death in patients treated with daratumumab. The safety profile observed in this study was consistent with the known safety profile of daratumumab, and no new safety signals were observed.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

September: Genmab commenced binding arbitration of two matters arising under the license agreement with Janssen relating to daratumumab.
August: The U.S. FDA approved the use of DARZALEX® (daratumumab) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. The approval was based on the Phase 3 CANDOR study (NCT03158688), which was sponsored by Amgen. In November 2020 the MHLW in Japan also approved daratumumab in this indication. In addition to the submissions by Janssen, in February 2020 Amgen submitted an application for approval in Europe based on CANDOR.
June: Janssen submitted a regulatory application in China for daratumumab in combination with bortezomib and dexamethasone (Vd) adult patients with relapsed or refractory multiple myeloma, based on the Phase 3 LEPUS (NCT03234972) study.
June: The European Commission (EC) granted marketing authorization for the SubQ formulation of DARZALEX® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with multiple myeloma in all currently approved daratumumab IV formulation indications in frontline and relapsed / refractory settings.
May: The U.S. FDA approved the use of the SubQ formulation of daratumumab, known in the U.S. as DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), for the treatment of adult patients with multiple myeloma in certain indications as noted in the previous table.
April: Janssen submitted a New Drug Application (NDA) to the MHLW in Japan for the SubQ formulation of daratumumab.
January: The EC granted marketing authorization for DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for ASCT. The approval was supported by data from the first part of the Phase 3 CASSIOPEIA (NCT02541383) study.

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DARATUMUMAB DEVELOPMENT COVERING ALL STAGES OF MULTIPLE MYELOMA AND BEYOND – KEY ONGOING* TRIALS

Graphical user interface

Description automatically generated

*Does not include trials that may still be ongoing but have clinical data with published results and/or are the basis for an existing approval

 Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson, entered a global license and development agreement for daratumumab. Genmab received an upfront license fee of USD 55 million and Johnson and Johnson Development Corporation (JJDC) invested USD 80 million to subscribe for 5.4 million new Genmab shares. Genmab could also be entitled to up to USD 1,015 million in development, regulatory and sales milestones, in addition to tiered double digit royalties between 12% and 20%. To date Genmab has recorded USD 835 million in milestone payments from Janssen and could be entitled to receive up to USD 180 million in further payments if certain additional milestones are met. The following royalty tiers apply for net sales in a calendar year: 12% on net sales up to USD 750 million; 13% on net sales between USD 750 million and USD 1.5 billion; 16% on net sales between USD 1.5 billion and USD 2.0 billion; 18% on net sales between USD 2.0 billion and USD 3.0 billion; and 20% on net sales exceeding USD 3.0 billion. Janssen is fully responsible for developing and commercializing daratumumab and all costs associated therewith.

Daratumumab Collaboration with Janssen Biotech, Inc.

In 2012, Genmab and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, entered a global license and development agreement for daratumumab. Genmab received an upfront license fee of USD 55 million, and Johnson & Johnson Development Corporation (JJDC) invested USD 80 million to subscribe for 5.4 million new Genmab shares. Genmab could also be entitled to up to USD 1,015 million in development, regulatory and sales milestones, in addition to tiered double digit royalties between 12% and 20%. To date Genmab has recorded USD 850 million in milestone payments from Janssen and could be entitled to receive up to USD 165 million in further payments if certain additional milestones are met. The following royalty tiers apply for net sales in a calendar year: 12% on net sales up to and including USD 750 million; 13% on net sales above USD 750 million and up to and including USD 1.5 billion; 16% on net sales above USD 1.5 billion and up to and including USD 2.0 billion; 18% on net sales above USD 2.0 billion and up to and including USD 3.0 billion; and 20% on net sales exceeding USD 3.0 billion. Janssen is fully responsible for developing and commercializing daratumumab and all costs associated therewith. In September 2020, Genmab commenced binding arbitration of two matters arising under the license agreement with Janssen relating to daratumumab. The arbitration is to settle whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc., for the Halozyme enzyme technology used in the subcutaneous formulation of daratumumab and whether Janssen’s obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering daratumumab. Please refer to “Legal Matter – Janssen Binding Arbitration” on page 128.

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Kesimpta® (ofatumumab)

Approved in RMS in the U.S.

Human CD20 monoclonal antibody developed and commercialized by Novartis under a license agreement with Genmab
Approved by the U.S. FDA for treatment of relapsing forms of multiple sclerosis (RMS) in adults
First B-cell therapy that can be self-administered by patients at home 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 forming part of ofatumumab. A SubQ formulation of ofatumumab was investigated in two Phase 3 ASCLEPIOS clinical studies in RMS. The studies compared the efficacy and safety of SubQ ofatumumab versus teriflunomide in patients with RMS and were comprised of approximately 900 patients each. Based on these studies and data from the Phase 2 APLIOS study, which evaluated the bioequivalence of SubQ administration of ofatumumab via pre-filled syringe in August 2020, Kesimpta® (ofatumumab) was approved by the U.S. FDA for the treatment of RMS in adults. Kesimpta® is the first B-cell therapy that can be self-administered by patients at home using the Sensoready® autoinjector pen, once monthly after starting therapy. Additional studies with RMS patients are ongoing. Ofatumumab in RMS is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG. (See Ofatumumab Collaboration with Novartis Pharma AG section for more information.)

Please consult the full U.S. Prescribing Information for all the labeled safety information for Kesimpta®.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

August: The U.S. FDA approved the use of Kesimpta® (ofatumumab) injection for subcutaneous use for the treatment of RMS in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In February 2020 the sBLA submitted by Novartis was accepted by the U.S. FDA with Priority Review, and at the end of January 2020 a Marketing Authorization Application (MAA) was accepted by the EMA. In July 2020 Novartis submitted an application for approval in this indication in Japan. The submissions were based on data from the Phase 3 ASCLEPIOS I and II (NCT02792218 and NCT02792231) and the Phase 2 APLIOS (NCT03560739) studies. The filing in Japan was also based on the Phase 2 COMB157G1301 (NCT03249714) study.
May: Data from the Phase 3 ASCLEPIOS I and II studies and the Phase 2 APLIOS study were presented virtually at the 6th Congress of the European Academy of Neurology (EAN). Data from the ASCLEPIOS studies were also published in the August 6, 2020 issue of The New England Journal of Medicine. Updated data was subsequently presented at the 8th Joint Americas / European Committees for Treatment and Research in Multiple Sclerosis (ACTRIMS –ECTRIMS) Meeting in September 2020.
February: Positive data from the Phase 2 APLIOS study, which evaluated the bioequivalence of SubQ administration of ofatumumab via pre-filled syringe, as used in the Phase 3 ASCLEPIOS I and

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II studies, and an autoinjector pen in patients with RMS, was presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in Florida.

About Multiple Sclerosis

· Chronic disorder of the central nervous system that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss

·

85% of MS cases are relapsing remitting multiple sclerosis (RRMS), characterized by unpredictable recurrent attacks1

·

2.3M people affected worldwide1

1 Healthline https://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic. Updated August 2020.

Ofatumumab Collaboration with Novartis Pharma AG (Novartis)

Genmab and GlaxoSmithKline (GSK) entered a co-development and collaboration agreement for ofatumumab in 2006. The full rights to ofatumumab were transferred from GSK to Novartis in 2015. Novartis is now fully responsible for the development and commercialization of ofatumumab in all potential indications, including autoimmune diseases. Genmab is entitled to a 10% royalty payment of net sales for non-cancer treatments. In 2020 subcutaneous ofatumumab was approved by the U.S. FDA, as Kesimpta®, for the treatment of RMS in adults. Ofatumumab was also previously approved as Arzerra® for certain chronic lymphocytic leukemia (CLL) indications. In 2019, the marketing authorization for Arzerra® was withdrawn in the EU and several other territories. In August 2020, Genmab announced that Novartis planned to transition Arzerra® to an oncology access program for CLL patients in the U.S. Genmab recognized USD 30 million lump sum from Novartis as payment for lost potential royalties. Ofatumumab is no longer in development for CLL.

TEPEZZA® (teprotumumab)

First U.S. FDA-approved medicine for the treatment of TED

Developed and manufactured by Horizon Therapeutics, plc (Horizon) for thyroid eye disease (TED)
First and only U.S. FDA-approved medicine for the treatment of TED
Also being explored in diffuse cutaneous systemic sclerosis (dcSSC)

Teprotumumab, approved by the U.S. FDA in January 2020 under the trade name TEPEZZA®, is a human monoclonal antibody that targets the Insulin-like Growth Factor-1 Receptor (IGF-1R), a well-validated target. Genmab used technology licensed from Medarex to generate the IGF-1R antibody forming part of teprotumumab. TEPEZZA® is being developed and is commercialized by Horizon. 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 license from Roche. Under the terms of Genmab’s agreement with

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Roche, Genmab will receive mid-single digit royalties on sales of TEPEZZA®. Please consult the full U.S. Prescribing Information for all the labeled safety information for TEPEZZA®.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

July: A Phase 1 study (NCT04478994) to explore teprotumumab for patients with dcSSC was published on www.clinicaltrials.gov.
January: The U.S. FDA approved TEPEZZA® for the treatment of TED.

Rare, progressive and vision-threatening autoimmune disease1

Associated with thyroid disease, affecting the ocular and orbital tissues1

Misalignment of the eyes (strabismus) and double vision (diplopia) are reported in about 50% of people with TED2

Annual incidence is approximately 3 out of 100,000 men and 16 out of 100,000 women3

Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
2 Horizon Therapeutics, Understanding Thyroid Eye Disease (TED), https://www.horizontherapeutics.com/PDFs/TED_fact_sheet.pdf, Accessed February 2020
3 Bahn RS. Graves’ ophthalmopathy. N Engl J Med. 2010;362:726-738.

About TED

·

Rare, progressive and vision-threatening autoimmune disease1

·

Associated with thyroid disease, affecting the ocular and orbital tissues1

·

Misalignment of the eyes (strabismus) and double vision (diplopia) are reported in about 50% of people with TED2

·

Annual incidence is approximately 3 out of 100,000 men and 16 out of 100,000 women3

1 Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
2 Horizon Therapeutics, Understanding Thyroid Eye Disease (TED), https://www.horizontherapeutics.com/PDFs/TED_fact_sheet.pdf. Accessed February 2020.
3 Bahn RS. Graves’ ophthalmopathy. N Engl J Med. 2010;362:726-738.

Proprietary Products in Development

Product candidates where Genmab has ≥50% ownership.

Tisotumab vedotin

A Next-generation Therapeutic

An investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a protein highly prevalent in solid tumors, including cervical cancer, and is associated with poor prognosis
Very favorable topline results announced for the Phase 2 potential registration study in metastatic cervical cancer (mCC); a BLA submission is planned to support a potential accelerated approval pathway with the U.S. FDA
Phase 2 clinical studies in ovarian and other solid tumors ongoing
Developed in collaboration with Seagen

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Tisotumab vedotin is an ADC targeted to TF, a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF is a suitable target for an ADC approach. Genmab used technology licensed from Medarex to generate the TF antibody forming part of tisotumab vedotin. Tisotumab vedotin is in clinical development for solid tumors. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

KEY TRIALS

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Cancer that originates in the cells lining the cervix

65.8% 5-year survival rate in the U.S.2

13,170 women estimated diagnosed with and 4,250 estimated to have died from cervical cancer in the U.S. in 20192

570,000 women estimated diagnosed with and 311,000 estimated to have died from cervical cancer in 2018, the vast majority in the developing world3

Statistics include all stages of cervical cancer. Tisotumab vedotin is in clinical trials for recurrent or metastatic cervical cancer

National Cancer Institute SEER. “Cancer Stat Facts: Cervical Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html. Accessed December 2019.

Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2019.

About Cervical Cancer1

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Cancer that originates in the cells lining the cervix

·

4th most frequently diagnosed and 4th most deadly cancer in women worldwide2

·

In developing regions, ranked 2nd in incidence and mortality in women2

In 2018, nearly 570,000 women were newly diagnosed with cervical cancer and 311,000 women were estimated to have died worldwide,2 with the majority of the deaths occurring in the developing world3
Up to 16% of women initially present with metastatic cervical cancer, and those who present with earlier-stage disease may experience recurrency following treatment4,5
Among women who present with earlier-stage disease, 15-61% will go on to develop metastic cervical cancer6

1 General statistics include all stages of cervical cancer. Tisotumab vedotin is in clinical trials for recurrent or metastatic 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 Organization WH. Early diagnosis and screening: cervical cancer. 2019. https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/. Accessed 27 Sep, 2019.

4 Insititute NC. SEER Cancer Stat Facts: Cervical Cancer. 2020. https://seer.cancer.gov/statfacts/html/cervix.html. Accessed July 27, 2020.

5 McLachlan J, Boussios S, Okines A, et al. The impact of systemic therapy beyond first-line treatment for advanced cervical cancer. Clinical oncology (Royal College of Radiologists (Great Britain)). 2017;29(3):153-160.

6 Pfaendler KS, Tewari KS. Changing paradigms in the systemic treatment of advanced cervical cancer. Am J Obstet Gynecol. 2016;214(1):22-30.

FOURTH QUARTER UPDATE

October: Genmab and Seagen entered into a joint commercialization agreement. Refer to note 5.8 for details of the joint commercialization agreement.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

September: Data from the Phase 2 innovaTV 204 (NCT03438396) study of tisotumab vedotin for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer featured in a late-breaking proffered paper oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
June: Announced very favorable topline results from the Phase 2 single-arm innovaTV 204 study. Results from the study showed a 24% confirmed objective response rate (ORR) by independent central review (95% Confidence Interval: 15.9% - 33.3%) with a median duration of response (DOR) of 8.3 months. The most common treatment-related adverse events (greater than or equal to 20%) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye.

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Tisotumab Vedotin Collaboration with Seagen

In September 2010, Genmab and Seagen entered into an ADC collaboration, and a commercial license and collaboration agreement was executed in October 2011. Under the agreement, Genmab was granted rights to utilize Seagen’s ADC technology with its human monoclonal TF antibody. Seagen was granted rights to exercise a co-development and co-commercialization option at the end of Phase 1 clinical development for tisotumab vedotin. In August 2017, Seagen exercised its option to co-develop and co-commercialize tisotumab vedotin with Genmab. Under the agreement, Seagen and Genmab will each be responsible for leading tisotumab vedotin commercialization activities in certain territories. In October 2020, Genmab and Seagen entered into a joint commercialization agreement. Genmab will co-promote tisotumab vedotin in the U.S., and we will lead commercial operational activities and book sales in Japan, while Seagen will lead operational commercial activities in the U.S., Europe and China with a 50:50 cost and profit split in those markets. In any other markets, Seagen will be responsible for commercializing tisotumab vedotin and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. The companies will continue the practice of joint decision-making on the worldwide development and commercialization strategy for tisotumab vedotin.

Epcoritamab (DuoBody-CD3xCD20)

Potential Best-in-class Product Candidate

Proprietary bispecific antibody product created with Genmab’s DuoBody® technology
Ongoing clinical studies include: Phase 3 in relapsed / refractory diffuse large B-cell lymphoma (DLBCL); Phase 2 expansion part in patients with relapsed, progressive or refractory B-cell lymphoma; Phase 1b exploring combinations with multiple standard of care treatments
Developed in collaboration with AbbVie

Epcoritamab is a proprietary bispecific antibody created using Genmab’s DuoBody® technology. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically well-validated target on malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab. Epcoritamab is being co-developed by Genmab and AbbVie. The first Phase 3 clinical study of epcoritamab in relapsed / refractory DLBCL was announced in November 2020. In addition, Phase 1/2 clinical studies in B-cell non-Hodgkin lymphoma (B-NHL) including CLL and in combination with standard of care therapies for B-NHL are ongoing.

FOURTH QUARTER UPDATES

December: Updated data from the dose escalation part of the first in human trial of epcoritamab in B-NHL, including results for patients treated at the recommended Phase 2 dose, was presented during an oral session of the 62nd American Society of Hematology (ASH) Virtual Annual Meeting.
November: The first Phase 3 study (NCT04628494) of epcoritamab in relapsed / refractory DLBCL was announced.
November: Two Phase 1/2 studies announced; monotherapy in CLL (NCT04623541) and in combination with standard of care in B-NHL (NCT04663347).

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UPDATES FROM FIRST QUARTER TO THIRD QUARTER

July: The first patient was dosed in the expansion part of the Phase 1/2 study of epcoritamab for patients with relapsed, progressive or refractory B-cell lymphoma.
June: Included in the broad oncology collaboration between Genmab and AbbVie. See below and “AbbVie Collaboration Agreement” on page 96 for more details.

Key Trials

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Cancer that originates in the cells lining the cervix

65.8% 5-year survival rate in the U.S.2

13,170 women estimated diagnosed with and 4,250 estimated to have died from cervical cancer in the U.S. in 20192

570,000 women estimated diagnosed with and 311,000 estimated to have died from cervical cancer in 2018, the vast majority in the developing world3

Statistics include all stages of cervical cancer. Tisotumab vedotin is in clinical trials for recurrent or metastatic cervical cancer

National Cancer Institute SEER. “Cancer Stat Facts: Cervical Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html. Accessed December 2019.

Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2019.

About Diffuse Large B-cell Lymphoma

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide1
DLBCL is an aggressive NHL that develops from B cells2
DLBCL accounts for ~1/3 of all NHLs3,4
63.8% 5-year survival rate3
Prognosis for relapsed or refractory DLBCL patients is poor, especially for those with high-risk factors5
For most patients with refractory DLBCL there are no curative treatment options5

1Li S, et al. Pathology. 2018;50(1):74-87.

2Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed December 2020.

3National Institutes of Health. SEER Cancer Stat Facts: DLBCL. https://seer.cancer.gov/statfacts/html/dlbcl.html. Accessed January 23, 2020.

4Gouveia GR, et al. Rev Bras Hematol Hemoter. 2012; 34(6): 447–451.

5Crump, 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/.

Epcoritamab Collaboration with AbbVie

In June 2020, Genmab entered into a broad collaboration agreement to jointly develop and commercialize epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4, and a discovery research collaboration for future differentiated antibody therapeutics for cancer. For epcoritamab, the companies will share commercial responsibilities 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 receive tiered royalties on remaining global net sales.

Under the terms of the agreement, Genmab received a USD 750 million upfront payment with the potential for Genmab to receive up to USD 3.15 billion in additional development, regulatory and net sales milestone revenue for all programs, 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 net sales, the parties share in pre-tax profits from the sale of products on a 50:50 basis. Included in these potential milestones are up to USD 1.15 billion in milestone payments related to clinical development and commercial success across the three existing bispecific antibody programs. Genmab and AbbVie split 50:50 the development costs related to epcoritamab. See “AbbVie Collaboration Agreement” on page 96 for more details.

DuoBody-PD-L1x4-1BB (GEN1046)

Potential First-in-Class Bispecific Next-generation Checkpoint Immunotherapy

Bispecific antibody product created with Genmab’s DuoBody® technology

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Phase 1/2 clinical study in solid tumors ongoing
Created and developed in collaboration with BioNTech

DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody® technology. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for the product on a 50:50 basis. DuoBody-PD-L1x4-1BB targets PD-L1 and 4-1BB, selected to block inhibitory PD-1 / PD-L1 axis and simultaneously conditionally activate essential co-stimulatory activity via 4-1BB using inert DuoBody® antibody format. A Phase 1/2 clinical study of DuoBody-PD-L1x4-1BB in solid tumors is ongoing.

FOURTH QUARTER UPDATE

November: First preliminary clinical data presented at the SITC 35th Anniversary Annual Meeting.

UPDATE FROM FIRST QUARTER TO THIRD QUARTER

Q1: Expansion cohort initiated in Phase 1/2 (NCT03917381) study in solid tumors.

DuoBody-CD40x4-1BB (GEN1042)

Potential First-in-Class Bispecific Agonistic Antibody

Bispecific antibody product created with Genmab’s DuoBody® technology
Phase 1/2 clinical study in solid tumors ongoing
Created and developed in collaboration with BioNTech

DuoBody-CD40x4-1BB (GEN1042) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody® technology. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and profits for the product on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells (DC) and antigen-dependent T-cell activation, using an inert DuoBody® format. A Phase 1/2 clinical study (NCT04083599) of DuoBody-CD40x4-1BB in solid tumors is ongoing.

HexaBody-DR5/DR5 (GEN1029)

First HexaBody® Program in Clinical Development

Proprietary antibody product created with Genmab’s HexaBody® technology
Composed of two non-competing HexaBody® antibody molecules that target two distinct DR5 epitopes
Phase 1/2 clinical study in solid tumors ongoing

HexaBody-DR5/DR5 (GEN1029) is a product comprising a mixture of two non-competing HexaBody® antibody molecules that target two distinct epitopes on death receptor 5 (DR5), a cell surface receptor that

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mediates a process called programmed cell death. Increased expression of DR5 has been reported in several types of tumors. The product was created with our HexaBody® technology and DR5 antibodies acquired from IDD Biotech. HexaBody-DR5/DR5 is fully owned by Genmab and a Phase 1/2 clinical study in solid tumors is ongoing.

UPDATE FROM FIRST QUARTER TO THIRD QUARTER

June: Pre-clinical data was presented at the 25th European Hematology Association (EHA25) Virtual Congress 2020.

DuoHexaBody-CD37 (GEN3009)

First DuoHexaBody® Program in Clinical Development

Antibody product created with Genmab’s DuoHexaBody® technology
Developed in collaboration with AbbVie
Phase 1/2 clinical study in hematologic malignancies ongoing

DuoHexaBody-CD37 (GEN3009) is a bispecific IgG1 antibody created with Genmab’s proprietary DuoHexaBody® technology platform. The DuoHexaBody® platform combines the dual targeting of our DuoBody® technology with the enhanced potency of our HexaBody® technology, creating bispecific antibodies with target-mediated enhanced hexamerization. In pre-clinical settings, DuoHexaBody-CD37 has been shown to induce potent in vitro and in vivo anti-tumor activity. This suggests that DuoHexaBody-CD37 is a promising candidate for B-cell malignancies. An IND was submitted to the U.S. FDA in November 2019 and the first patient was dosed with DuoHexaBody-CD37 in March 2020. DuoHexaBody-CD37 is being co-developed by Genmab and AbbVie.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

June: Pre-clinical data was presented at the EHA25 Virtual Congress 2020.
June: Included in the broad oncology collaboration between Genmab and AbbVie. See “AbbVie Collaboration Agreement” on page 96 for more details.
March: First patient dosed in the first-in-human trial (NCT04358458) in hematologic malignancies.

DuoBody-CD3x5T4 (GEN1044)

Most Recent Program in the Clinic

Bispecific antibody product created with Genmab’s DuoBody® technology
Phase 1/2 clinical study in malignant solid tumors ongoing
Developed in collaboration with AbbVie

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DuoBody-CD3x5T4 (GEN1044) is a bispecific IgG1 antibody created with Genmab’s proprietary DuoBody® technology platform. In pre-clinical settings, DuoBody-CD3x5T4 showed potent antitumor activity in vitro and in vivo in a range of cancer indications. In addition, the broad expression of 5T4 across cancer indications and limited expression in normal cells makes DuoBody-CD3x5T4 a promising novel drug candidate. The first CTAs were submitted for DuoBody-CD3x5T4 in Europe in January 2020 and the first patient was dosed with DuoBody-CD3x5T4 in August 2020. DuoBody-CD3x5T4 is being co-developed by Genmab and AbbVie.

FOURTH QUARTER UPDATE

November: Pre-clinical data presented at the SITC 35th Anniversary Annual Meeting.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

August: First patient dosed in first-in-human trial (NCT04424641) in solid tumors.
June: Included in the broad oncology collaboration between Genmab and AbbVie. See “AbbVie Collaboration Agreement” on page 96 for more details.
January: First CTAs submitted in Europe.

Product Candidates Incorporating Genmab’s Innovation

In addition to Genmab’s own pipeline of product candidates, our innovations are found in the pipelines of other companies that are running clinical development programs with antibodies created by Genmab or created using our DuoBody® bispecific antibody technology.

Amivantamab (JNJ-61186372)

DuoBody® product targeting epidermal growth factor receptor (EGFR) and cMET
Janssen submitted applications for approval to U.S. and European authorities seeking approval for amivantamab in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy – first regulatory submissions for a DuoBody® product candidate
Developed by Janssen under the DuoBody® Research and License Agreement

Amivantamab (JNJ-61186372) is a bispecific antibody that targets EGFR and cMet, two validated cancer targets. Amivantamab was created under a collaboration with Genmab and Janssen using Genmab’s DuoBody® technology. The two antibodies used to generate amivantamab were both created by Genmab and further optimized and developed by Janssen, who is investigating amivantamab in Phase 2 and Phase 3 clinical studies to treat NSCLC. Janssen’s BLA and MAA submissions for amivantamab are the first for a product candidate created using Genmab’s proprietary DuoBody® technology platform.

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FOURTH QUARTER UPDATE

December: Janssen submitted a BLA to U.S. FDA and an MAA to the EMA seeking approval for amivantamab for patients with metastatic NSCLC with EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

September: Janssen presented data in NSCLC at the ESMO Virtual Congress 2020.
Q3: Janssen published two Phase 3 studies in NSCLC indications (PAPILLON (NCT04538664) and MARIPOSA (NCT04487080)) on www.clinicaltrials.gov.
June: Janssen presented results from the Phase 1 CHRYSALIS study in advanced NSCLC with EGFR Exon20 insertion mutations at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.
March: The U.S. FDA granted Janssen a BTD for amivantamab for the treatment of patients with NSCLC with EGFR Exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Teclistamab (JNJ-64007957)

DuoBody® product targeting BCMA and CD3
Multiple clinical studies in multiple myeloma ongoing
Developed by Janssen under the DuoBody® Research and License Agreement

Teclistamab (JNJ-64007957) is a bispecific antibody that targets BCMA, which is expressed in mature B lymphocytes, and CD3, which is expressed on T-cells. Teclistamab was created by Janssen using Genmab’s DuoBody® technology and is being investigated in Phase 1 and Phase 2 clinical studies for the treatment of multiple myeloma, including in combination with daratumumab.

FOURTH QUARTER UPDATEs

December: Janssen presented data during an oral session of the 62nd ASH Virtual Annual Meeting.
October: Janssen published a Phase 1 study (NCT04586426) combining teclistamab and talquetamab in relapsed or refractory multiple myeloma on www.clinicaltrials.gov.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

September: Janssen published the first Phase 2 study (NCT04557098) in patients with relapsed or refractory multiple myeloma on www.clinicaltrials.gov. Progress in the program triggered a milestone to Genmab.
June: Janssen presented results from the Phase 1 first-in-human study in relapsed or refractory multiple myeloma at the ASCO20 Virtual Scientific Program.

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Mim8

DuoBody® product in development by Novo Nordisk for hemophilia
First DuoBody® product candidate in indication outside of oncology
Phase 2 clinical study in hemophilia A ongoing

Mim8 is a bispecific antibody created under a collaboration between Genmab and Novo Nordisk using Genmab’s DuoBody® technology. Novo Nordisk is investigating Mim8 in a Phase 2 study of patients with hemophilia A with or without Factor VIII inhibitors.

FOURTH QUARTER UPDATE

November: Mim8 moved into Part 2 of the Phase 1/2 (NCT04204408) study. The first part of the study, which was initiated in January 2020, investigated Mim8 in healthy subjects and the second part of the study is examining patients with hemophilia A with or without Factor VIII inhibitors.

PRV-015 (AMG 714)

Antibody targeting IL-15
Phase 2 clinical study in non-responsive celiac disease (NRCD) ongoing

PRV-015 (AMG 714) is a human monoclonal antibody that binds to Interleukin-15 (IL-15), a cytokine molecule appearing early in the cascade of events that ultimately leads to inflammatory disease. AMG 714 was created under a collaboration with Amgen. In November 2018, Amgen entered into a licensing and co-development agreement with Provention Bio, Inc. to run a Phase 2b clinical study of AMG 714, now known as PRV-015, for the treatment of gluten-free diet NRCD.

UPDATE FROM FIRST QUARTER TO THIRD QUARTER

August: Initiation of a Phase 2b (NCT04424927) study in NRCD.

Camidanlumab tesirine (ADCT-301)

Phase 2 clinical study in relapsed or refractory Hodgkin lymphomas and Phase 1 clinical study in solid tumors ongoing
Genmab and ADC Therapeutics executed amended agreement for ADC Therapeutics to continue the development and commercialization of camidanlumab tesirine against royalty payments to Genmab

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Camidanlumab tesirine is an ADC that combines Genmab’s HuMax-TAC antibody and ADC Therapeutics’ PBD-based warhead and linker technology. Camidanlumab tesirine targets CD25, which is expressed on a variety of hematological tumors and shows limited expression on normal tissues, making it an attractive target for antibody-payload approaches. Camidanlumab tesirine is in clinical development with ADC Therapeutics. In October 2020, Genmab and ADC Therapeutics executed an amended agreement for ADC Therapeutics to continue the development and commercialization of camidanlumab tesirine. Under the terms of the amended and restated license agreement, Genmab and ADC Therapeutics agreed to eliminate the defined divestment process, which was agreed in 2013 and that envisaged, among other things, offering the opportunity for third parties to continue the development and commercialization of camidanlumab tesirine. With the amendment Genmab converted its economic interest, which included 25% of the product rights, into a mid-to-high single-digit tiered royalty on net sales. A Phase 2 study of camidanlumab tesirine to treat relapsed or refractory Hodgkin lymphoma and a Phase 1 study of camidanlumab tesirine to treat solid tumors are ongoing.

FOURTH QUARTER UPDATES

December: Data was presented during an oral session of the 62nd ASH Virtual Annual Meeting.
October: Genmab and ADC Therapeutics executed amended agreement.

UPDATE FROM FIRST QUARTER TO THIRD QUARTER

September: Data from the Phase 1b (NCT03621982) study of camidanlumab tesirine for patients with selected locally advanced or metastatic solid tumors was presented at the ESMO Virtual Congress 2020.

HuMax-IL8

Human antibody in clinical development by Bristol-Myers Squibb (BMS-986253)
Phase 1/2 clinical study in advanced cancers ongoing

HuMax-IL8 is a high affinity fully human antibody directed toward IL-8. IL-8 has been shown to be involved in several aspects of tumor development including tumor spread (metastasis), cancer stem cell renewal and tumor immune-suppression. HuMax-IL8 has been shown to inhibit these processes and to inhibit tumor growth in pre-clinical tumor models. HuMax-IL8 was created by Genmab and is in development for the treatment of advanced cancers with Bristol-Myers Squibb.

Talquetamab (JNJ-64407564)

DuoBody® product targeting GPRC5D and CD3
Multiple clinical studies in multiple myeloma announced and ongoing
Developed by Janssen under the DuoBody® Research and License Agreement

Talquetamab (JNJ-64407564) is a bispecific antibody that targets GPRC5D, which is highly expressed on multiple myeloma cells and CD3, which is expressed on T-cells. Talquetamab was created by Janssen using

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Genmab’s DuoBody® technology. Talquetamab is being investigated in Phase 1 and Phase 2 clinical studies for the treatment of multiple myeloma, including in combination with daratumumab.

FOURTH QUARTER UPDATEs

December: Janssen presented data during an oral session of the 62nd ASH Virtual Annual Meeting.
November: Jansen published the first Phase 2 study (NCT04634552) in patients with relapsed or refractory multiple myeloma on www.clinicaltrials.gov.
October: Janssen published a Phase 1 study (NCT04586426) combining teclistamab and talquetamab in relapsed or refractory multiple myeloma on www.clinicaltrials.gov.

JNJ-70218902

Phase 1 clinical study in advanced-stage solid tumors ongoing
Developed by Janssen under the DuoBody® Research and License Agreement

JNJ-70218902 is a bispecific antibody created by Janssen using Genmab's DuoBody® technology. It is being investigated in a Phase 1 clinical study for the treatment of advanced-stage solid tumors.

UPDATE FROM FIRST QUARTER TO THIRD QUARTER

September: Janssen initiated a Phase 1 (NCT04397276) study of JNJ-70218902 in patients with advanced solid tumors.

JNJ-63709178

DuoBody® product targeting CD123 and CD3
Phase 1 clinical study in relapsed or refractory AML ongoing
Developed by Janssen under the DuoBody® Research and License Agreement

JNJ-63709178 is a bispecific antibody that targets CD3, which is expressed on T-cells, and CD123, which is overexpressed in various hematologic malignancies. JNJ-63709178 may redirect T-cells, resulting in T-cell mediated killing of CD123+ acute myeloid leukemia (AML) cells. JNJ-63709178 was created by Janssen using Genmab’s DuoBody® technology. JNJ-63709178 is being investigated in a Phase 1 clinical study for the treatment of AML.

JNJ-67571244

DuoBody® product targeting CD33 and CD3
Phase 1 clinical study for relapsed or refractory AML or MDS ongoing
Developed by Janssen under the DuoBody® Research and License Agreement

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JNJ-67571244 is a bispecific antibody that targets CD3, which is expressed on T-cells and CD33, which is frequently expressed in AML and myelodysplastic syndrome (MDS). JNJ-67571244 was created under a collaboration between Genmab and Janssen using Genmab’s DuoBody® technology. JNJ-67571244 is being investigated in a Phase 1 clinical study to treat relapsed or refractory AML or MDS.

JNJ-63898081

DuoBody® product targeting PSMA and CD3
Phase 1 clinical study for advanced solid tumors ongoing
Developed by Janssen under the DuoBody® Research and License Agreement

JNJ-63898081 is a bispecific antibody that targets prostate-specific membrane antigen (PSMA), which is highly expressed on prostate adenocarcinomas, and CD3, which is expressed on T-cells. JNJ-63898081 was created under a collaboration between Genmab and Janssen using Genmab’s DuoBody® technology. JNJ-63898081 is being investigated in a Phase 1 clinical study to treat advanced solid tumors.

Lu AF82422

Human monoclonal antibody product targeting alpha-synuclein in development by Lundbeck
Phase 1 study in healthy volunteers and patients with Parkinson’s disease ongoing

Lu AF82422 is a human antibody that targets the protein alpha-synuclein. Abnormal aggregation of alpha-synuclein is believed to play a pivotal role in the development and progression of neurodegenerative disorders with synucleinopathies, e.g., Parkinson’s disease, multiple system atrophy and dementia with Lewy bodies. Lu AF82422 targets the underlying biology and aims to slow or stop disease progression. Lu AF82422 was invented by Lundbeck in collaboration with Genmab. Lu AF82422 is being investigated in a Phase 1 clinical study in both healthy volunteers and patients with Parkinson’s disease.

Pre-clinical Programs

Broad pre-clinical pipeline of approximately 20 programs including HexaBody-CD38 (GEN3014)
Pre-clinical pipeline includes both partnered products and in-house programs based on our proprietary technologies or antibodies
Multiple new INDs expected to be submitted over coming years
Genmab has entered multiple strategic collaborations to support the expansion of our innovative pipeline, including a broad oncology collaboration with AbbVie

Our pre-clinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody® technology and bispecific antibodies created with our DuoBody® platform. We are also working

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with our partners, including AbbVie, Immatics and CureVac N.V., to generate additional new product concepts. A number of the pre-clinical programs are carried out in cooperation with our collaboration partners.

FOURTH QUARTER UPDATES

December: Pre-clinical data for HexaBody-CD38 was presented during an oral session of the 62nd ASH Virtual Annual Meeting.
October: IND was filed for HexaBody-CD38.

UPDATES FROM FIRST QUARTER TO THIRD QUARTER

June: Entered into a broad oncology collaboration with AbbVie, which includes a discovery research collaboration. See “AbbVie Collaboration Agreement” on page 96 for more details.

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® 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 such as the OmniAb® transgenic mouse and rat platforms from Ligand Pharmaceuticals, Inc. We also use or license technologies to increase the potency of some of our antibody therapeutics on a product-by-product basis such as the ADC technology from Seagen. 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 Platform Technology Suite

Platform

Principle

Applications

DuoBody®

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Bispecific antibodies

Dual-targeting:

·

Recruitment (e.g., T cells)

·

Tumor heterogeneity

HexaBody®

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Target-mediated enhanced hexamerization

Enhanced potency:

·

Complement-dependent cytotoxicity (CDC)

·

Target clustering, outside-in signaling, apoptosis

DuoHexaBody®

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Bispecific antibodies with target-mediated enhanced hexamerization

Dual-targeting + enhanced potency:

·

CDC

·

Target clustering, outside-in signaling, apoptosis

HexElect®

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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® 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 submissions for a product candidate that was created using the DuoBody® technology platform – amivantamab (Janssen)

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First Genmab-sponsored Phase 3 study for a product candidate that was created using the DuoBody® – epcoritamab (50:50 with AbbVie)

The DuoBody® 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® 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® platform generates bispecific antibodies via a versatile and broadly applicable process which is easily performed at high throughput, standard bench, as well as commercial manufacturing scale. Genmab uses the DuoBody® platform to create its own bispecific antibody programs and the technology is also available for licensing. Genmab has numerous alliances for the DuoBody® platform including commercial collaborations with AbbVie, Janssen, Novo Nordisk, BioNTech, BliNK Biomedical and Immatics.

 Inc.

July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using our DuoBody platform. Under this original agreement, Janssen had the right to use the DuoBody technology to create panels of bispecific antibodies (up to 10 DuoBody programs) to multiple disease target combinations. Genmab received an upfront payment of USD 3.5 million from Janssen and will potentially be entitled to milestone and license payments of up to approximately USD 175 million, as well as royalties for each commercialized DuoBody product.

December 2013 amendment, Janssen was entitled to work on up to 10 additional programs. Genmab received an initial payment of USD 2 million from Janssen. Under the terms of the original agreement, for each of the additional programs that Janssen successfully initiates, develops and commercializes, Genmab will potentially be entitled to receive average milestone and license payments of approximately USD 191 million. In addition, Genmab will be entitled to royalties on sales of any commercialized products. All research work is funded by Janssen.

December 31, 2018, Janssen had exercised 14 licenses under this collaboration. No further options remain for use by Janssen. As of December 31, 2019, six DuoBody product candidates created under this collaboration were in the clinic.

May 2015, Genmab entered an agreement with BioNTech AG to jointly research, develop and commercialize bispecific antibody products using Genmab’s DuoBody technology platform. Under the terms of the agreement, BioNTech will provide proprietary antibodies against key immunomodulatory targets, while Genmab provides antibodies and access to its DuoBody technology platform. Genmab paid an upfront fee of USD 10 million to BioNTech and an additional USD 2 million (out of a potential of USD 5 million) as certain BioNTech assets were selected for further development. If the companies jointly select any 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 a product candidate forward, the other company is entitled to continue developing the product 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 have selected two product candidates for clinical development, DuoBody-CD40x4-1BB (GEN1042) and DuoBody-PD-L1x4-1BB (GEN1046), both of which are now in Phase I clinical trials.

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. The bispecific antibodies will target a disease area outside of cancer therapeutics. Under the terms of the agreement, Genmab received an upfront payment of USD 2 million from Novo Nordisk. After an initial period of exclusivity for both target combinations, Novo Nordisk has extended exclusivity of the commercial license for one target combination in 2018. Under the exclusive license agreement, Genmab is entitled to potential development, regulatory and sales milestones of up to approximately USD 250 million. In addition, Genmab will be entitled to single-digit royalties on sales of any commercialized products. In December 2017, the collaboration was expanded to include an additional five potential target pair combinations and three commercial license options. Genmab received an upfront payment of USD 2 million from Novo Nordisk and will be entitled to milestones and single digit royalties on eventual product sales. The first clinical trial for Mim8, a DuoBody product candidate for hemophilia being developed by Novo Nordisk under this collaboration, was published on www.clinicaltrials.gov in December.

July 2019, Genmab entered into an agreement with BliNK Biomedical for an exclusive commercial license to certain antibodies targeting CD47, for potential development and commercialization into novel bispecific therapeutics created via Genmab’s proprietary DuoBody Platform technology. Under the terms of the agreement, Genmab paid BliNK Biomedical an upfront fee of USD 2.25 million. BliNK Biomedical is also eligible to receive up to approximately USD 200 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.

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Commercial DuoBody® Product Collaborations

AbbVie

On June 10, 2020, Genmab entered into a broad oncology collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4. For epcoritamab, the companies will share commercial responsibilities 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 receive tiered royalties on remaining global sales. For DuoHexaBody-CD37, DuoBody-CD3x5T4 and 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 received a USD 750 million upfront payment from AbbVie with the potential for Genmab to receive up to USD 3.15 billion in additional development, regulatory and sales milestone payments for all programs, 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 share in pre-tax profits from the sale of products on a 50:50 basis. Included in these potential milestones are up to USD 1.15 billion in payments related to clinical development and commercial success across the three existing bispecific antibody programs. Genmab and AbbVie split 50:50 the development costs related to epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4.

BioNTech

In May 2015, Genmab entered an agreement with BioNTech to jointly research, develop and commercialize bispecific antibody products 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 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 a product candidate forward, the other company is entitled to continue developing the product 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 have selected two product candidates for clinical development, DuoBody-CD40x4-1BB (GEN1042) and DuoBody-PD-L1x4-1BB (GEN1046), both of which are now in clinical trials.

Janssen

In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using our DuoBody® platform. Under this original agreement, Janssen had the right to use the DuoBody® technology to create panels of bispecific antibodies (up to 10 DuoBody® programs) to multiple disease target combinations. Genmab received an upfront payment of USD 3.5 million from Janssen and will potentially be entitled to milestone and license payments of up to approximately USD 175 million, as well as royalties for each commercialized DuoBody® product.

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Under the terms of a December 2013 amendment, Janssen was entitled to work on up to 10 additional programs. Genmab received an initial payment of USD 2 million from Janssen. Under the terms of the original agreement, for each of the additional programs that Janssen successfully initiates, develops and commercializes, Genmab will potentially be entitled to receive average milestone and license payments of approximately USD 191 million. In addition, Genmab will be entitled to royalties on sales of any commercialized products. All research work is funded by Janssen.

Janssen has exercised 14 licenses under this collaboration, not all of which are active, and no further options remain for use by Janssen. As of December 31, 2020, seven DuoBody® product candidates created under this collaboration were in the clinic. One of these, amivantamab, is the first product candidate created using the DuoBody® technology platform to be submitted for regulatory approval.

Novo Nordisk A/S

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. The bispecific antibodies will target a disease area outside of cancer therapeutics. After an initial period of exclusivity for both target combinations, Novo Nordisk has 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 development, regulatory and sales milestones of up to approximately USD 250 million. In addition, Genmab will be entitled to single-digit royalties on sales of any commercialized products. In December 2017, the collaboration was expanded with a new agreement for up to an additional five potential target pair combinations, which may be reserved on either an exclusive or non-exclusive basis, and three commercial license options. This agreement contained similar termination provisions as the initial agreement.

BliNK Biomedical SAS

In July 2019, Genmab entered into an agreement with BliNK Biomedical for an exclusive commercial license to certain antibodies targeting CD47, for potential development and commercialization into novel bispecific therapeutics created via Genmab’s proprietary DuoBody® Platform technology. Under the terms of the agreement, BliNK Biomedical is also eligible to receive up to approximately USD 200 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.

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 product, as well as tiered royalties on net sales.

Genmab A/S

Tel: +45 7020 2728

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