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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 AUGUST 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 

Exhibit 99.1 to this report on Form 6-K shall be deemed to be incorporated by reference in Genmab A/S’s registration statement on Form S-8 (File No. 333-232693) and in the outstanding prospectus contained in such registration statement.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

GENMAB A/S

BY:

/s/ Anthony Pagano

Name: Anthony Pagano

Title: Executive Vice President & Chief Financial Officer

DATE: August 11, 2021

EXHIBIT INDEX

A

Exhibit

Description of Exhibit

99.1

Interim Report Dated August 11, 2021

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

Exhibit 99.1

Graphic

Genmab Announces Financial Results for the First Half of 2021

August 11, 2021; Copenhagen, Denmark;

Interim Report for the First Half of 2021

Highlights

The U.S. FDA accepted for Priority Review the tisotumab vedotin Biologics License Application (BLA), for patients with recurrent or metastatic cervical cancer
DARZALEX® net sales increased 52% compared to the first half of 2020 to USD 2,798 million, resulting in royalty income of DKK 2,360 million
Following a positive CHMP opinion, Janssen-Cilag International NV received European Marketing Authorization for DARZALEX SC (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed light-chain (AL) amyloidosis
Genmab improves its 2021 financial guidance

“Genmab’s antibody expertise and innovation were on display during the second quarter of 2021 with the U.S. FDA’s acceptance for priority review of the BLA for tisotumab vedotin, which we are developing with Seagen, and with the approval of Janssen’s RYBREVANT™ (amivantamab-vmjw), the first regulatory approval for a product created using Genmab’s proprietary DuoBody® technology platform. The majority of Genmab’s clinical stage products are based on our DuoBody technology, and we hope that the approval of RYBREVANT is just the first validation of many of the potential for this technology to create effective treatments for patients with cancer,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2021

Net sales of DARZALEX by Janssen Biotech, Inc. (Janssen) were USD 2,798 million in the first half of 2021 compared to USD 1,838 million in the first half of 2020, an increase of USD 960 million, or 52%.
Royalty revenue was DKK 2,595 million in the first half of 2021 compared to DKK 1,738 million in the first half of 2020, an increase of DKK 857 million, or 49%. The increase was driven by higher net sales of DARZALEX, TEPEZZA® and Kesimpta® resulting in higher royalties.
Total revenue for the first half of 2021 was DKK 3,553 million. In addition to the royalty revenue described above, Genmab also recognized DKK 731 million of milestone revenue during the first half of 2021. Revenue for the first half of 2020 was DKK 6,343 million and included the one-time upfront payment of DKK 4,398 million recognized as license revenue from AbbVie Inc. (AbbVie) pursuant to our collaboration announced in June 2020.
Operating expenses were DKK 2,234 million in the first half of 2021 compared to DKK 1,775 million in the first half of 2020. The increase of DKK 459 million, or 26%, was driven by the continued advancement of multiple pipeline projects, and the increase in new employees to support the expansion of our product pipeline and building our commercialization capabilities and broader organizational infrastructure.
Operating result was DKK 1,319 million in the first half of 2021 compared to DKK 4,568 million in the first half of 2020. The decrease of DKK 3,249 million, or 71%, was driven by lower revenue as a result of the non-recurring license revenue in 2020 and increased operating expenses.

Outlook

Genmab is improving its 2021 financial guidance published on February 23, 2021, driven primarily by increased royalty revenue related to the net sales of DARZALEX.

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CVR no. 2102 3884

Graphic

Genmab Announces Financial Results for the First Half of 2021

Revised

Previous

(DKK million)

    

Guidance

    

Guidance

    

Revenue

 

7,300 - 7,900

 

6,800 - 7,500

 

Operating expenses

 

(5,500) - (5,800)

 

(5,500) - (5,800)

 

Operating result

 

1,500 - 2,400

 

1,000 - 2,000

 

Conference Call

Genmab will hold a conference call to discuss the results for the first half of 2021 today, Wednesday, August 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial

+1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 78377092.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

Contact:

Marisol Peron, Senior Vice President, Global Investor Relations and Communications

T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com

Genmab A/S

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CVR no. 2102 3884

Graphic

Interim Report for the First Half of 2021

CONTENTS

M

MANAGEMENT‘S REVIEW

CONSOLIDATED KEY FIGURES

4

OUTLOOK

5

KEY 2021 PRIORITIES

6

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2021

6

SIGNIFICANT RISKS AND UNCERTAINTIES

15

FINANCIAL REVIEW

16

FINANCIAL STATEMENTS

STATEMENT OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2021

21

STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2021

22

BALANCE SHEET AS OF JUNE 30, 2021

23

STATEMENT OF CASH FLOWS FOR THE FIRST HALF OF 2021

24

STATEMENT OF CHANGES IN EQUITY FOR THE FIRST HALF OF 2021

25

NOTES TO THE FINANCIAL STATEMENTS

26

ABOUT GENMAB

34

DIRECTORS’ AND MANAGEMENT’S STATEMENT ON THE INTERIM REPORT

35

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CVR no. 2102 3884

Graphic

Interim Report for the First Half of 2021

CONSOLIDATED KEY FIGURES

  

2nd Quarter of

  

2nd Quarter of

6 Months Ended

  

6 Months Ended

Full Year

2021

2020

June 30, 2021

June 30, 2020

2020

(DKK million)

Income Statement

 

  

  

 

  

Revenue

 

1,972

5,451

3,553

6,343

10,111

Research and development expenses

 

(921)

(775)

(1,769)

(1,490)

(3,137)

General and administrative expenses

 

(264)

(179)

(465)

(285)

(661)

Operating expenses

 

(1,185)

(954)

(2,234)

(1,775)

(3,798)

Operating result

 

787

4,497

1,319

4,568

6,313

Net financial items

 

(365)

(169)

527

114

(409)

Net result

 

306

3,378

1,402

3,647

4,758

Balance Sheet

 

Cash position*

 

17,875

12,782

17,875

12,782

16,079

Total non-current assets

 

2,179

1,542

2,179

1,542

2,352

Total assets

 

22,483

20,683

22,483

20,683

21,143

Shareholders' equity

 

20,252

17,871

20,252

17,871

19,121

Share capital

 

66

65

66

65

66

Cash Flow Statement

 

Cash flow from operating activities

 

355

239

1,540

2,153

6,433

Cash flow from investing activities

 

1,545

919

966

928

(2,351)

Cash flow from financing activities

 

(240)

4

(460)

19

71

Cash and cash equivalents

 

9,477

6,605

9,477

6,605

7,260

Cash position increase/(decrease)

 

(208)

(178)

1,796

1,811

5,108

Investment in tangible assets

 

(79)

(145)

(107)

(203)

(307)

Financial Ratios

 

 

Basic net result per share

 

4.68

51.88

21.44

 

56.07

73.00

Diluted net result per share

 

4.64

51.35

21.25

 

55.52

72.21

Period-end share market price

 

2,566

2,220

2,566

 

2,220

2,463

Price / book value

 

8.36

8.07

8.36

 

8.07

8.50

Shareholders' equity per share

 

306.85

274.94

306.85

 

274.94

289.71

Equity ratio

 

90

%

86

%

90

%

86

%

90

%

Shares outstanding

65,620,740

65,346,580

65,620,740

65,346,580

65,545,748

Average number of employees (FTE**)

 

969

614

906

 

591

656

Number of employees at the end of the period

 

1,029

636

1,029

 

636

781

*  Cash, cash equivalents, and marketable securities.

** Full-time equivalent

Genmab A/S

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CVR no. 2102 3884

Graphic

Interim Report for the First Half of 2021

OUTLOOK

Revised

Previous

(DKK million)

    

Guidance

    

Guidance

    

Revenue

 

7,300 - 7,900

 

6,800 - 7,500

 

Operating expenses

 

(5,500) - (5,800)

 

(5,500) - (5,800)

 

Operating result

 

1,500 - 2,400

 

1,000 - 2,000

 


Genmab is improving its 2021 financial guidance published on February 23, 2021, driven primarily by increased royalty revenue related to the net sales of DARZALEX.

Revenue

Genmab expects its 2021 revenue to be in the range of DKK 7,300–7,900 million, an increase compared to previous guidance of DKK 6,800-7,500 million, driven primarily by the continued strong growth of DARZALEX net sales. Genmab’s projected revenue for 2021 primarily consists of DARZALEX royalties of DKK 5,300–5,700 million. Such royalties are based on Genmab’s revised estimate of DARZALEX 2021 net sales of USD 5.6–5.9 billion compared to Genmab’s previous estimate of USD 5.2-5.6 billion. Since the second quarter of 2020, Janssen has reduced 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 (SC) sales. Given the ongoing arbitration, Genmab has reflected this as a reduction to estimated 2021 revenue. The remainder of Genmab’s revenue consists of royalties from TEPEZZA and Kesimpta, reimbursement revenue, milestones for epcoritamab and daratumumab, and other milestones.

Operating Expenses

Genmab anticipates its 2021 operating expenses to be in the range of DKK 5,500–5,800 million, which is in line with previous guidance. Operating expenses continue to be driven by the advancement of Genmab’s clinical programs, continued investment in research and development, as well as building Genmab’s commercial organization and broader organizational infrastructure.

Operating Result

Genmab now expects its 2021 operating result to be in the range of DKK 1,500–2,400 million, an increase compared to previous guidance of DKK 1,000-2,000 million, driven primarily by the increase in royalty revenue related to the net sales of DARZALEX.

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 Genmab’s collaboration agreements; ongoing binding arbitration of two matters under Genmab’s license agreement with Janssen relating to daratumumab; the timing and variation of development activities (including activities carried out by Genmab’s collaboration partners) and related income and costs; DARZALEX, Kesimpta, TEPEZZA and RYBREVANT 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 new agreements are entered into during the remainder of 2021 that could materially affect the results. Refer to the section “Significant Risks and Uncertainties” in this interim report. Additionally, the COVID-19 pandemic could potentially have a material adverse impact on Genmab’s business and financial performance, including clinical trials, projected regulatory approval timelines, supply chain and revenues, and cause Genmab’s actual results to differ materially from 2021 Guidance and Key 2021 Priorities in this interim report.

The global outbreak of COVID-19 may have long-term impacts on the development, regulatory approval and commercialization of Genmab’s product candidates and on net sales of approved products created by

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CVR no. 2102 3884

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Interim Report for the First Half of 2021

Genmab and developed and marketed by Genmab’s collaboration partners. The longer the pandemic continues, the more severe the impacts described below will be on Genmab’s 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 the workplace and on our communities, and ensures business continuity. Genmab is also actively monitoring the potential impact on Key 2021 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. The full extent and nature of the impact of the COVID-19 pandemic and related containment measures on Genmab’s business and financial performance is uncertain as the situation continues to evolve. The factors discussed above, as well as other factors which are currently unforeseeable, may result in further and other unforeseen material adverse impacts on Genmab’s business and financial performance, including on the net sales of DARZALEX, Kesimpta, TEPEZZA and RYBREVANT, by Genmab’s partners and on Genmab’s royalty and milestone revenue therefrom.

KEY 2021 PRIORITIES

Priority

Targeted Milestones

Bring our own medicines to patients

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

X

*

Tisotumab vedotin – JNDA submission in cervical cancer

Epcoritamab2 – acceleration and maximization of development program by advancing expansion cohorts and initiating additional Phase 3 trials

Build world-class differentiated product

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. Co-development w/ Seagen Inc. (Seagen); 2. Co-development w/ AbbVie; 3. Co-development w/ BioNTech SE (BioNTech)

*Potential JNDA filing timeline postponed to include Phase 3 InnovaTV301 data

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2021

As of the end of the second quarter, Genmab’s proprietary pipeline of product candidates, where we are responsible for at least 50% of development costs, consisted of eight clinical stage antibodies. In addition to our own pipeline, there are also 15 products in development by third-party companies, including four approved products, which incorporate Genmab technology and innovation. Beyond the antibodies in clinical development, our pipeline also includes around 20 in-house and partnered preclinical programs. An overview of the development status of each of our products 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 and may also be found in Genmab’s filings with the U.S. Securities and Exchange Commission (SEC). Additional information is available on Genmab’s website, www.genmab.com. The information accessible through our website is not part of and is not incorporated by reference herein.

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CVR no. 2102 3884

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Interim Report for the First Half of 2021

Genmab Proprietary Products1 in Development

Chart

Description automatically generated

1Product candidates where Genmab has ≥50% ownership. Certain products in co-development, partners as indicated

2Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen

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, which is associated with poor prognosis
Based on data from the innovaTV 204 (NCT03438396) Phase 2 single-arm clinical study evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer, a BLA was submitted to the U.S. Food and Drug Administration (U.S. FDA); potential Japanese New Drug Application (JNDA) filing timeline postponed to include Phase 3 innovaTV 301 (NCT04697628) data
U.S. FDA accepted the BLA with Priority Review; under the Prescription Drug User Fee Act (PDUFA), the U.S. FDA set a target action date of Oct 10, 2021
Phase 3 study in recurrent or metastatic cervical cancer and multiple Phase 2 clinical studies in other solid tumors ongoing
Developed in collaboration with Seagen

Tisotumab vedotin is an ADC targeted to TF, a protein involved in tumor signaling and angiogenesis. It is composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. 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. Under a joint commercialization agreement, Genmab will co-

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promote tisotumab vedotin in the U.S. and lead commercial operational activities in Japan. 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 commercialize 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.

Second Quarter 2021 Updates

May: innovaTV 204 data published in The Lancet Oncology, “Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study.”
April: The U.S. FDA accepted for Priority Review the BLA seeking accelerated approval for tisotumab vedotin. The BLA requests U.S. FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The FDA has set a target action date of Oct 10, 2021.

First Quarter 2021 Updates

February: Genmab and Seagen submitted a BLA to the U.S. FDA seeking accelerated approval for tisotumab vedotin for patients with recurrent or metastatic cervical cancer with disease progression on or after first line standard of care. The submission is based on the results of the innovaTV 204 (NCT03438396) Phase 2 single-arm clinical study evaluating tisotumab vedotin as monotherapy in this setting.
January: A Phase 3 study of tisotumab vedotin versus chemotherapy in recurrent or metastatic cervical cancer (innovaTV 301 (NCT04697628)) was announced.

Epcoritamab (DuoBody-CD3xCD20) – Potential Best-in-class Product Candidate

Proprietary bispecific antibody created with Genmab’s DuoBody technology
Five ongoing clinical studies across different settings and histologies, including a Phase 3 study (NCT04628494) in relapsed / refractory diffuse large B-cell lymphoma (DLBCL) with more studies in planning
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 (NCT04628494) of epcoritamab in relapsed / refractory DLBCL is ongoing. In addition, Phase 1/2 clinical studies in B-cell non-Hodgkin lymphoma (B-NHL) including chronic lymphocytic leukemia (CLL) (NCT04623541) and in combination with standard of care therapies for B-NHL (NCT04663347) are ongoing.

Second Quarter 2021 Update

June: Updated dose escalation data, including progression free survival, from the Phase 1/2 study of epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NCT03625037) presented during an oral session at the International Conference on Malignant Lymphoma and poster sessions at the American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Congress.

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First Quarter 2021 Updates

February: “Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment” published in Blood Cancer Journal.
January: The first patient was dosed in the Phase 3 study (NCT04628494) of SC epcoritamab versus investigator’s choice of chemotherapy in patients with relapsed or refractory DLBCL. This triggered a DKK 245 million (USD 40 million) milestone to Genmab under the collaboration with AbbVie.

DuoBody-PD-L1x4-1BB (GEN1046) – Bispecific Next Generation Checkpoint Immunotherapy

Bispecific antibody created with Genmab’s DuoBody technology
Clinical studies in solid tumors ongoing
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. Two clinical studies (NCT03917381, NCT04937153) in solid tumors are ongoing.

DuoBody-CD40x4-1BB (GEN1042) – Potential First-in-Class Bispecific Agonistic Antibody

Bispecific antibody created with Genmab’s DuoBody technology
Phase 1/2 clinical study (NCT04083599) in solid tumors ongoing
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.

Second Quarter 2021 Update

April/May: Preclinical data was presented at the American Association for Cancer Research Annual Meeting.

HexaBody-DR5/DR5 (GEN1029) – First HexaBody® Program in Clinical Development

Proprietary antibody therapeutic 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 (NCT03576131) in solid tumors ongoing

HexaBody-DR5/DR5 (GEN1029) is a product comprising a mixture of two non-competing HexaBody molecules that target two distinct epitopes on death receptor 5 (DR5), a cell surface receptor that 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 (NCT03576131) in solid tumors is ongoing.

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DuoHexaBody-CD37 (GEN3009) – First DuoHexaBody® Program in the Clinic

Antibody product created with Genmab’s DuoHexaBody technology
Phase 1/2 clinical study (NCT04358458) in hematologic malignancies ongoing
Developed in collaboration with AbbVie

DuoHexaBody-CD37 (GEN3009) is a bispecific 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. DuoHexaBody-CD37 is being co-developed by Genmab and AbbVie on a 50:50 basis and a Phase 1/2 clinical study (NCT04358458) in hematologic malignancies is ongoing.

DuoBody-CD3x5T4 (GEN1044) – Promising Novel Product Candidate

Bispecific antibody product created with Genmab’s DuoBody technology
Phase 1/2 clinical study (NCT04424641) in solid tumors ongoing
Developed in collaboration with AbbVie

DuoBody-CD3x5T4 (GEN1044) is a bispecific antibody created with Genmab’s proprietary DuoBody technology platform. DuoBody-CD3x5T4 induces T-cell mediated cytotoxicity of 5T4-positive cells by crosslinking CD3 on T cells with the tumor-associated antigen 5T4 on tumor cells. The broad expression of 5T4 across solid tumors and limited expression in normal cells makes DuoBody-CD3x5T4 a promising novel product candidate. DuoBody-CD3x5T4 is being co-developed by Genmab and AbbVie on a 50:50 basis and a Phase 1/2 clinical study (NCT04424641) in solid tumors is ongoing.

HexaBody-CD38 (GEN3014) – Latest Proprietary Program in the Clinic

Proprietary antibody therapeutic created with Genmab’s HexaBody technology
Potential in hematological malignancies; first patient dosed in the first-in-human study (NCT0482479) in March 2021
Developed in an exclusive worldwide license and option agreement with Janssen Biotech, Inc. (Janssen)

HexaBody-CD38 (GEN3014) is a human CD38 monoclonal antibody product incorporating our HexaBody technology. In preclinical models of hematological malignancies, as presented at ASH in December 2019, HexaBody-CD38 demonstrated enhanced CDC and had shown potent anti-tumor activity. In June 2019, Genmab entered into an exclusive worldwide license and option agreement with Janssen to develop and commercialize HexaBody-CD38. An Investigational New Drug (IND) application was submitted to the U.S. FDA for HexaBody-CD38 in October 2020 followed by Clinical Trial Application submissions in Europe in November 2020. The first patient was dosed in the first-in-human study (NCT0482479) in March 2021 and the study is ongoing.

First Quarter 2021 Update

March: First patient dosed in first-in-human study (NCT0482479) of HexaBody-CD38.

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Products Created by Genmab or Incorporating Genmab’s Innovation

In addition to Genmab’s own pipeline of product candidates, our innovations are applied in the pipelines of other companies that are running clinical development programs with antibodies created by Genmab or created using Genmab’s DuoBody bispecific antibody technology. Under these agreements, Genmab is entitled to certain potential milestones and royalties.

Approved Medicines

Table

Description automatically generated with medium confidence

*See local country prescribing information for precise indications

DARZALEX (daratumumab)

– Redefining the Treatment of Multiple Myeloma

First-in-class human CD38 monoclonal antibody
Developed by Janssen under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab
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 SC CD38-directed antibody approved in territories including the U.S., Europe and Japan for the treatment of certain multiple myeloma indications, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., and DARZALEX SC in Europe
SC daratumumab is the first and only approved therapy for AL amyloidosis in the U.S. and Europe
Net sales of DARZALEX by Janssen were USD 2,798 million in the first half of 2021

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 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

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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. Under the terms of the agreement, Genmab is entitled to double digit royalties between 12% and 20%. Daratumumab (marketed as DARZALEX for intravenous administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for SC administration) is approved in certain territories for the treatment of adult patients with certain multiple myeloma indications and is the only approved therapy in the U.S. and Europe for the treatment of adult patients with AL amyloidosis.

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 of the labeled safety information.

Second Quarter 2021 Updates

June: Janssen received approval from the European Commission for the daratumumab SC formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX SC in the European Union, in two indications: in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic AL amyloidosis and in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. The approvals follow positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2021. The approvals were based on the Phase 3 ANDROMEDA (AMY3001 / NCT03201965) and APOLLO (MMY3013 / NCT03180736) studies, respectively.
June: Overall survival results from Janssen’s Phase 3 MAIA (MMY3008 / NCT02252172) study of daratumumab in combination with lenalidomide and dexamethasone (D-Rd) versus Rd alone in patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplant (ASCT) were presented during the late-breaking oral session at EHA.
April: Janssen received approval in China based on the Phase 3 LEPUS (MMY3009, NCT03234972) study of daratumumab in combination with bortezomib and dexamethasone in Chinese patients with relapsed or refractory multiple myeloma.

First Quarter 2021 Update

January: Janssen was granted U.S. FDA approval for the use of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with VCd for the treatment of adult patients with newly diagnosed AL amyloidosis. The approval was based on data from the Phase 3 ANDROMEDA study (AMY3001 / NCT03201965)).

Kesimpta (ofatumumab) – Approved in RMS in the U.S.

Human CD20 monoclonal antibody developed by Novartis under a license agreement with Genmab
Approved in territories including the U.S., EU and Japan 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

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the CD20 antibody forming part of ofatumumab. A SC formulation of ofatumumab was investigated in two Phase 3 ASCLEPIOS clinical studies (NCT02792218, NCT02792231) in RMS. The studies compared the efficacy and safety of SC ofatumumab versus teriflunomide in patients with RMS and were comprised of approximately 900 patients each. Based on these studies, Kesimpta (ofatumumab) was approved by the U.S. FDA in August 2020 and the European Commission (EC) in March 2021 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. Under the terms of the agreement, Genmab is entitled to 10% royalties on net sales of Kesimpta.

Please consult the full U.S. Prescribing Information and the full European Summary of Product Characteristics for the labeled safety information for Kesimpta (ofatumumab).

First Quarter 2021 Updates

March: The EC granted Novartis marketing authorization for the use of Kesimpta (ofatumumab) in the treatment of RMS in adults with active disease defined by clinical or imaging features. This was preceded in January 2021 by a positive opinion from the CHMP of the EMA recommending marketing authorization in the same indication.

TEPEZZA (teprotumumab-trbw) – First U.S. FDA-approved medicine for the treatment of thyroid eye disease

Developed and commercialized 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 sublicense from Roche. Under the terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on sales of TEPEZZA. In December 2020, Horizon announced that there was a supply disruption related to the production of TEPEZZA due to U.S. government-mandated COVID-19 vaccine production requirements. Subsequently, in March 2021, Horizon announced its plans to resupply the market beginning in April 2021.

Please consult the full U.S. Prescribing Information for all of the labeled safety information for TEPEZZA (teprotumumab-trbw).

RYBREVANT (amivantamab-vmjw)

– First regulatory approval for a DuoBody product

Part of Genmab and Janssen DuoBody research and license agreement
First U.S. FDA approved product created using Genmab’s proprietary DuoBody technology platform
Under the agreement with Janssen, Genmab will receive royalties on net sales of RYBREVANT

Janssen’s RYBREVANT (amivantamab-vmjw) is a fully human bispecific antibody that targets EGFR and cMet, two validated cancer targets. In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. The two antibody libraries used to produce amivantamab were both generated by Genmab. The antibody pair used to create

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Amivantamab was selected in collaboration between Genmab and Janssen. Subsequent development work was led by Janssen.

In 2021, Janssen received approval from the U.S. FDA for RYBREVANT for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. This is the first regulatory approval for a therapy that was created using Genmab’s proprietary DuoBody bispecific technology platform.

Please consult the full U.S. Prescribing Information for RYBREVANT (amivantamab-vmjw) for all of the labeled indication and safety information.

Second Quarter 2021 Update

May: Janssen was granted U.S. FDA approval for the use of RYBREVANT (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Clinical Stage Product Candidates

Janssen’s bispecific program applying the proprietary DuoBody technology platform accounts for approximately half of the clinical stage product candidates incorporating Genmab’s innovation that are in development with other companies. Janssen received Breakthrough Therapy Designation (BTD) by the U.S. FDA for teclistamab for the treatment of relapsed or refractory multiple myeloma in June 2020. Multiple abstracts related to Janssen’s DuoBody programs were also presented at the 2021 ASCO annual meeting.

Graphical user interface, application

Description automatically generated

*UltiMab® transgenic mouse technology licensed from Medarex, Inc., a wholly owned subsidiary of Bristol Myers Squibb.


Preclinical Programs

Broad preclinical pipeline of around 20 programs
Preclinical 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

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Genmab has entered multiple strategic collaborations to support the expansion of our innovative pipeline, including a broad oncology collaboration with AbbVie

Our preclinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody technology and bispecific antibodies created with our DuoBody platform. We are also working with our partners, including AbbVie, BioNTech, Immatics, CureVac N.V. (CureVac) and Bolt Biotherapeutics, Inc. (Bolt), to generate additional new product concepts. A number of the preclinical programs are carried out in cooperation with our collaboration partners.

Second Quarter 2021 Update

May: Genmab and Bolt entered into an oncology research and development collaboration. The companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with Bolt’s proprietary Boltbody™ immune-stimulating antibody conjugate (ISAC) technology platform, with the goal of discovering and developing next-generation, immune-stimulatory, antibody-based conjugate therapeutics for the treatment of cancer. The research collaboration will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through clinical proof of concept. Under the terms of the agreement, Genmab paid Bolt an upfront payment of USD 10 million and a USD 15 million equity investment in Bolt in June 2021. Bolt is eligible to receive total potential milestone payments of up to USD 285 million per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties. Genmab will fully fund preclinical and early clinical development of all candidates. If a candidate is co-developed, development costs will be split 50:50 between the two companies, and the companies will be solely responsible for commercialization costs in their respective territories and shall pay each other royalties on product sales.

SIGNIFICANT RISKS AND UNCERTAINTIES

As a biotech company, Genmab faces a number of risks and uncertainties. These are common for the industry and relate to operations, intellectual property, research and development, commercial and financial activities. For further information about risks and uncertainties, which the Genmab group faces, refer to the 2020 Annual Report filed with NASDAQ Copenhagen in February 2021 and the Form 20-F filed with the U.S. SEC in March 2021. At the date of this interim report, there have been no significant changes to Genmab’s overall risk profile since the publication of the Form 20-F; however, 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. See Genmab’s Form 20-F for a detailed summary of risks related to our collaborations as well as risks related to the COVID-19 pandemic.

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FINANCIAL REVIEW

The interim report is prepared on a consolidated basis for the Genmab group. The financial statements are published in Danish Kroner (DKK).

Revenue

Genmab’s revenue was DKK 3,553 million for the first half of 2021 compared to DKK 6,343 million for the first half of 2020. The decrease of DKK 2,790 million, or 44%, was primarily driven by the one-time upfront payment of DKK 4,398 million recognized as license revenue from AbbVie pursuant to our collaboration announced in June 2020, partly offset by higher DARZALEX royalties as well as milestone revenue from various collaboration partners.

(DKK million)

    

H1 2021

    

H1 2020

Royalties

 

2,595

 

1,738

Reimbursement revenue

 

227

 

175

Milestone revenue

 

731

 

32

License revenue

4,398

Total revenue

 

3,553

 

6,343

Royalties

Royalty revenue amounted to DKK 2,595 million in the first half of 2021 compared to DKK 1,738 million in the first half of 2020. The increase of DKK 857 million, or 49%, was primarily driven by higher DARZALEX royalties achieved under our daratumumab collaboration with Janssen.

Net sales of DARZALEX by Janssen were USD 2,798 million in the first half of 2021 compared to USD 1,838 million in the first half of 2020. The increase of USD 960 million, or 52%, was driven by the continued strong uptake of DARZALEX. Royalty revenue on net sales of DARZALEX was DKK 2,360 million in the first half of 2021 compared to DKK 1,652 million in the first half of 2020, an increase of DKK 708 million. The percentage increase in royalties of 43% is lower than the percentage increase in the underlying net sales primarily due to the lower exchange rate between the USD and DKK in the first half of 2021 compared to the first half of 2020 and the impact of Janssen’s continued withholding of a portion of the royalty payments owed to Genmab. Since the second quarter of 2020, Janssen has reduced its quarterly royalty payments to Genmab by what Janssen claims to be Genmab’s share of Janssen’s royalty payments to Halozyme in connection with SC sales. Given the ongoing arbitration, Genmab has reflected this reduction in its royalty revenues each quarter. The impact to royalties in the first half of 2021 is estimated to be DKK 146 million.

TEPEZZA (teprotumumab-trbw) was launched by Horizon in the first quarter of 2020. In December 2020, Horizon announced that there was a supply disruption related to the production of TEPEZZA due to U.S. government-mandated COVID-19 vaccine production requirements. Subsequently, in March 2021, Horizon announced its plans to resupply the market beginning in April 2021. Royalties, which are based on net sales, amounted to DKK 162 million during the first half of 2021 compared to DKK 77 million during the first half of 2020. The increase of DKK 85 million was driven by the strong uptake of TEPEZZA.

Novartis was granted U.S. FDA approval for Kesimpta (ofatumumab) in relapsing multiple sclerosis and Genmab started recognizing royalties on net sales of Kesimpta during the third quarter of 2020.

Royalties, which are based on net sales, amounted to DKK 72 million for the first half of 2021.

Janssen was granted U.S. FDA approval for RYBREVANT (amivantamab-vmjw) (ofatumumab), a fully human bispecific antibody that targets EGFR and cMet, and Genmab started recognizing royalties on net sales of RYBREVANT during the second quarter of 2021. Royalties for the quarter were not material.

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Royalty revenue fluctuations from period to period are due primarily to the level of product net sales as well as foreign currency exchange rates.

Reimbursement Revenue

Reimbursement revenue amounted to DKK 227 million in the first half of 2021 compared to DKK 175 million in the first half of 2020. The increase of DKK 52 million, or 30%, was primarily driven by higher activities under our collaboration agreement with BioNTech for DuoBody-PD-L1x4-1BB.

Milestone Revenue

Milestone revenue was DKK 731 million in the first half of 2021 compared to DKK 32 million in the first half of 2020, an increase of DKK 699 million, primarily driven by the following:

AbbVie milestone of DKK 245 million (USD 40 million) triggered by the first patient dosed in the Phase 3 study of epcoritamab,
DARZALEX FASPRO milestone of DKK 184 million (USD 30 million) driven by the first commercial sale in the U.S. for patients with newly diagnosed AL amyloidosis,
Janssen DuoBody milestone of DKK 152 million (USD 25 million) driven by U.S. FDA approval for RYBREVANT, and
DARZALEX SC milestone of DKK 125 million (USD 20 million) driven by the first commercial sale in the EU for patients with newly diagnosed AL amyloidosis.

Milestone revenue may fluctuate significantly from period to period due to both the timing of achievements and the varying amount of each individual milestone under our license and collaboration agreements.

License Revenue

There was no license fee income during the first half of 2021. License revenue was DKK 4,398 million during the first half of 2020, which was driven by the delivery of licenses for three programs under the AbbVie collaboration.

Refer to Financial Statement Note 2 in this interim report for further details about revenue.

Research and Development Costs

Research and development costs amounted to DKK 1,769 million in the first half of 2021 compared to DKK 1,490 million in the first half of 2020. The increase of DKK 279 million, or 19%, was driven by the continued advancement of epcoritamab and DuoBody-PD-L1x4-1BB under our collaborations with AbbVie and BioNTech, respectively, and the increase in new employees to support the expansion of our product pipeline. During the first half of 2021, Genmab recorded DKK 331 million as compared to DKK 45 million during the first half of 2020 as a reduction to research and development costs for reimbursement related to the collaboration agreement with AbbVie. Pursuant to this agreement, which was entered into during the second quarter of 2020, Genmab and AbbVie share equally in both research and development costs.

Research and development costs accounted for 79% of total operating expenses in the first half of 2021 compared to 84% in the first half of 2020.

General and Administrative Expenses

General and administrative expenses were DKK 465 million in the first half of 2021 compared to DKK 285 million in the first half of 2020. The increase of DKK 180 million, or 63%, was driven by the increase in new employees as Genmab builds its commercialization capabilities and broader organizational infrastructure.

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Interim Report for the First Half of 2021

General and administrative expenses accounted for 21% of total operating expenses in the first half of 2021 compared to 16% in the first half of 2020.

Operating Result

Operating result was DKK 1,319 million in the first half of 2021 compared to DKK 4,568 million in the first half of 2020. The decrease of DKK 3,249 million, or 71%, was driven by lower revenue and increased operating expenses as described above.

Net Financial Items

Net financial items for the first half of 2021 were a gain of DKK 527 million compared to a gain of DKK 114 million in the first half of 2020. The increase of DKK 413 million was primarily driven by the strengthening of the USD against the DKK on Genmab’s U.S. denominated portfolio and cash holdings, partly offset by losses on marketable securities driven by movements in interest rates in the United States and Europe. Refer to Financial Statement Note 4 in this interim report for further details about the net financial items.

Corporate Tax

Corporate tax expense for the first half of 2021 was DKK 444 million compared to DKK 1,035 million for the first half of 2020. The decrease in corporate tax expense is primarily the result of Genmab’s lower net result before tax. The effective tax rate in the first half of 2021 was 24% compared to 22% in the first half of 2020.

Net Result

Net result for the first half of 2021 was DKK 1,402 million compared to DKK 3,647 million in the first half of 2020. The decrease was driven by the items described above.

Cash Position

Cash Position (DKK million)

    

June 30, 2021

    

December 31, 2020

Marketable securities

 

8,398

 

8,819

Cash and cash equivalents

 

9,477

 

7,260

Cash position

 

17,875

 

16,079

As of June 30, 2021, cash, cash equivalents and marketable securities (cash position) amounted to DKK 17,875 million, an increase of DKK 1,796 million, or 11%, from the beginning of 2021. The increase was primarily driven by Genmab’s operating result of DKK 1,319 million, net exchange rate gains of DKK 573 million due to the strengthening of the USD, and proceeds received of DKK 438 million from the sale of a portion of Genmab’s CureVac shares during the first half of 2021, partly offset by cash payments for the purchase of treasury shares of DKK 437 million during the first half of 2021. Refer to Financial Statement Note 3 in this interim report for further details about the sale of CureVac shares. Refer to Financial Statement Note 5 in this interim report for further details about the purchase of treasury shares.

As of June 30, 2021, Genmab’s USD denominated cash, cash equivalents and marketable securities represents 85% of Genmab’s cash position compared to 83% as of December 31, 2020.

Cash and cash equivalents included short-term marketable securities of DKK 2,569 million at the end of June 2021, compared to DKK 2,206 million at the end of December 2020. In accordance with our accounting policy, securities purchased with a maturity of less than three months at the date of acquisition are classified as cash and cash equivalents. Refer to Financial Statement Note 3 in this interim report for further details about our marketable securities.

Genmab A/S

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Cash Flow

Cash Flow (DKK million)

    

H1 2021

    

H1 2020

Cash provided by operating activities

 

1,540

 

2,153

Cash provided by investing activities

 

966

 

928

Cash (used in) provided by financing activities

 

(460)

 

19

Net cash provided by operating activities is primarily related to our operating result, changes in operating assets and liabilities, reversal of net financial items, and adjustments related to non-cash transactions. In the first half of 2021, as compared to the first half of 2020, the primary driver of lower cash provided by operating activities was due to decreased changes in operating assets and liabilities related to non-recurring DARZALEX milestones of DKK 1.7 billion achieved in the fourth quarter of 2019 that were received in 2020.

The change in cash provided by investing activities primarily reflects differences between the proceeds received from sale and maturity of our investments and amounts invested, and the investment in tangible assets. Sales and maturities of marketable securities exceeded purchases in both periods, but to a greater extent in the first half of 2020. For the first half of 2021, investing activities also includes the proceeds from the sale of CureVac shares of DKK 438 million.

Net cash used in financing activities is primarily related to the exercise of warrants, purchase of treasury shares, lease payments, and payment of withholding taxes on behalf of employees on net settled Restricted Stock Units (RSUs). In the first half of 2021, the primary driver of the cash used in financing activities was related to cash payments for the purchase of treasury shares of DKK 437 million.

Balance Sheet

As of June 30, 2021, total assets were DKK 22,483 million compared to DKK 21,143 million on December 31, 2020. As of June 30, 2021, assets are mainly comprised of a cash position of DKK 17,875 million and current receivables of DKK 2,429 million. The current receivables consist primarily of amounts related to royalties and milestones from our collaboration agreements.

As of June 30, 2021, total liabilities were DKK 2,231 million compared to DKK 2,022 million on December 31, 2020. The increase in total liabilities of DKK 209 million, or 10%, was primarily driven by corporate tax payable of DKK 186 million and an increase in lease liabilities of DKK 124 million related to the commencement of leases in Japan and the United States.

Shareholders’ equity as of June 30, 2021 was DKK 20,252 million compared to DKK 19,121 million on December 31, 2020. The increase of DKK 1,131 million, or 6%, was primarily driven by Genmab’s net result and the issuance of shares related to the share-based compensation plans, partly offset by the purchase of treasury shares. Genmab’s equity ratio remained unchanged at 90% as of June 30, 2021 compared to December 31, 2020.

As of June 30, 2021, the total number of employees was 1,029 compared to 636 employees as of June 30, 2020. The increase in employees was primarily driven by the expansion and acceleration of our pipeline, as well as investment in commercialization capabilities and broader organizational infrastructure.

Employees

    

June 30, 2021

    

June 30, 2020

Research and development employees

 

793

537

General and administrative employees*

 

236

99

Total employees

 

1,029

 

636

*Includes commercialization capabilities

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Legal Matter – Janssen Binding Arbitration

In September 2020, Genmab commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab. Under the license agreement, Genmab is, among other things, entitled to royalties from Janssen on sales of daratumumab (marketed as DARZALEX for intravenous administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for SC administration). The arbitration first 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 SC formulation of daratumumab. The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of SC daratumumab sales. 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 beginning in the second quarter of 2020 and has continued to do so through June 30, 2021. Given the ongoing arbitration, Genmab has reflected this reduction in its royalty revenues each quarter. The impact to the first half of 2021 royalties is estimated to be DKK 146 million. The impact to the first half of 2020 royalties is not material. The arbitration is also to settle 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 the product, as further defined and described in the license agreement.

Genmab A/S

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STATEMENT OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2021

Income Statement

2nd Quarter of

    

2nd Quarter of

2021

2020

(DKK million)

Revenue

1,972

5,451

Research and development expenses

(921)

(775)

General and administrative expenses

(264)

(179)

Operating expenses

(1,185)

 

(954)

Operating result

787

 

4,497

Financial income

65

42

Financial expenses

(430)

(211)

Net result before tax

422

 

4,328

Corporate tax

(116)

(950)

Net result

306

 

3,378

Basic net result per share

4.68

51.88

Diluted net result per share

4.64

51.35

Statement of Comprehensive Income

  

 

  

Net result

306

 

3,378

Other comprehensive income:

  

 

  

Amounts which will be re-classified to the income statement:

  

 

  

Adjustment of foreign currency fluctuations on subsidiaries

(13)

(9)

Total comprehensive income

293

 

3,369

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STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2021

Income Statement

    

    

6 Months Ended

    

6 Months Ended

 

Note

 

June 30, 2021

June 30, 2020

(DKK million)

 

 

Revenue

 

2

 

3,553

6,343

Research and development expenses

 

 

(1,769)

(1,490)

General and administrative expenses

 

 

(465)

(285)

Operating expenses

 

 

(2,234)

(1,775)

Operating result

 

 

1,319

4,568

Financial income

 

4

 

700

119

Financial expenses

4

(173)

(5)

Net result before tax

 

 

1,846

4,682

Corporate tax

 

 

(444)

(1,035)

Net result

 

 

1,402

3,647

Basic net result per share

 

 

21.44

56.07

Diluted net result per share

 

 

21.25

55.52

Statement of Comprehensive Income

 

 

  

  

Net result

 

 

1,402

3,647

Other comprehensive income:

 

  

 

Amounts which will be re-classified to the income statement:

 

  

 

Adjustment of foreign currency fluctuations on subsidiaries

28

Total comprehensive income

1,430

3,647

Genmab A/S

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BALANCE SHEET

    

    

June 30, 

    

December 31, 

Note

2021

2020

(DKK million)

ASSETS

 

  

 

  

 

  

Intangible assets

 

  

 

297

 

338

Property, plant and equipment

 

  

 

535

 

453

Right-of-use assets

 

7

 

384

 

283

Receivables

 

  

 

33

 

20

Deferred tax assets

 

  

 

177

 

177

Other investments

3

753

1,081

Total non-current assets

 

  

 

2,179

 

2,352

Corporate tax receivable

249

Receivables

 

  

 

2,429

 

2,463

Marketable securities

 

3

 

8,398

 

8,819

Cash and cash equivalents

 

  

 

9,477

 

7,260

Total current assets

 

  

 

20,304

 

18,791

Total assets

 

  

 

22,483

 

21,143

SHAREHOLDERS’ EQUITY AND LIABILITIES

 

  

 

  

 

  

Share capital

 

  

 

66

 

66

Share premium

 

  

 

11,940

 

11,894

Other reserves

 

  

 

82

 

54

Retained earnings

 

  

 

8,164

 

7,107

Shareholders' equity

 

  

 

20,252

 

19,121

Provisions

 

  

 

8

 

4

Lease liabilities

 

7

 

384

 

277

Deferred revenue

487

487

Other payables

 

  

 

1

 

1

Total non-current liabilities

 

  

 

880

 

769

Corporate tax payable

 

  

 

186

 

Lease liabilities

 

7

 

59

 

42

Deferred revenue

26

26

Other payables

 

  

 

1,080

 

1,185

Total current liabilities

 

  

 

1,351

 

1,253

Total liabilities

 

  

 

2,231

 

2,022

Total shareholders' equity and liabilities

 

  

 

22,483

 

21,143

Share-based instruments

 

5

 

  

 

  

Related parties

 

6

 

  

 

  

Subsequent events to the balance sheet date

 

8

 

  

 

  

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STATEMENT OF CASH FLOWS

6 Months Ended

6 Months Ended

    

Note

    

June 30, 2021

    

June 30, 2020

(DKK million)

Net result before tax

1,846

4,682

Reversal of financial items, net

(527)

(114)

Adjustments for non-cash transactions

227

182

Changes in operating assets and liabilities

(105)

(2,570)

Cash flow from operating activities before financial items

1,441

2,180

Interest received

107

77

Interest elements of lease payments

7

(6)

(3)

Interest paid

(4)

Corporate taxes paid

(2)

(97)

Cash flow from operating activities

1,540

2,153

Investment in tangible assets

(107)

(203)

Marketable securities bought

(7,410)

(3,006)

Marketable securities sold

8,137

4,137

Other investments bought

3

(92)

Other investments sold

3

438

Cash flow from investing activities

966

928

Warrants exercised

46

54

Principal elements of lease payments

(29)

(17)

Purchase of treasury shares

(437)

Payment of withholding taxes on behalf of employees on net settled RSUs

(40)

(18)

Cash flow from financing activities

(460)

19

Change in cash and cash equivalents

2,046

3,100

Cash and cash equivalents at the beginning of the period

7,260

3,552

Exchange rate adjustments

171

(47)

Cash and cash equivalents at the end of the period

9,477

6,605

Cash and cash equivalents include:

Bank deposits

6,908

3,602

Short-term marketable securities

2,569

3,003

Cash and cash equivalents at the end of the period

9,477

6,605

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STATEMENT OF CHANGES IN EQUITY

    

Share

    

Share

    

Translation

    

Retained

    

Shareholders'

capital

premium

reserves

earnings

equity

(DKK million)

 

Balance at December 31, 2019

 

65

 

11,755

 

98

 

2,130

 

14,048

Net result

 

3,647

 

3,647

Other comprehensive income

 

 

Total comprehensive income

 

 

 

 

3,647

 

3,647

Transactions with owners:

 

  

 

  

 

  

 

  

 

  

Exercise of warrants

 

71

 

71

Share-based compensation expenses

 

98

 

98

Net settlement of RSUs

(18)

(18)

Tax on items recognized directly in equity

 

25

 

25

Balance at June 30, 2020

 

65

11,826

98

5,882

17,871

Balance at December 31, 2020

 

66

 

11,894

 

54

 

7,107

 

19,121

Net result

 

1,402

 

1,402

Other comprehensive income

 

28

 

28

Total comprehensive income

 

 

 

28

 

1,402

 

1,430

Transactions with owners:

 

  

 

  

 

  

 

  

 

  

Exercise of warrants

 

46

 

46

Purchase of treasury shares

 

(447)

 

(447)

Share-based compensation expenses

 

142

 

142

Net settlement of RSUs

 

(40)

 

(40)

Balance at June 30, 2021

 

66

11,940

82

8,164

20,252

Genmab A/S

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Interim Report for the First Half of 2021

NOTES TO THE FINANCIAL STATEMENTS

Note 1 – Basis of Presentation

Accounting Policies

These interim statements of the Genmab group (Genmab or the Company) have been prepared in accordance with IAS 34 as issued by the International Accounting Standards Board (IASB) and in accordance with IAS 34 as endorsed by the EU and additional Danish disclosure requirements for interim reports of listed companies. The interim report has not been reviewed or audited by Genmab’s external auditors.

The interim report has been prepared using the same accounting policies as outlined in Section 1 – Basis of Presentation in the financial statements in the Genmab 2020 Annual Report (Annual Report). A number of new or amended standards became applicable for the current reporting period. Genmab was not required to change its accounting policies as a result of adopting these standards. These interim financial statements should be read in conjunction with the Annual Report.

Management Judgments and Estimates under IFRS

In preparing interim reports, certain provisions under IFRS require management to make judgments (various accounting estimates and assumptions) which may significantly impact the group’s financial statements. For a description of significant judgments and estimates, refer to Note 1.3 in the Annual Report.

Information about Geographical Areas

Genmab is managed and operated as one business unit, which is reflected in the organizational structure and internal reporting. No separate lines of business or separate business entities have been identified with respect to any licensed products, product candidates or geographical markets and no segment information is currently prepared for internal reporting. Refer to Note 2.2 in the Annual Report for further details.

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Note 2 – Revenue

Genmab enters into license and collaboration agreements that are within the scope of IFRS 15, under which it licenses certain rights to its product candidates to third parties and also may participate in the development of the product candidates. The terms of these arrangements typically include payment to Genmab of one or more of the following: non-refundable, upfront license fees; exclusive designation fees; annual license maintenance fees; additional target fees; development, regulatory and commercial milestone payments; reimbursements for research and development services; and royalties on net sales of licensed products. Each of these payments results in revenue from contracts with customers.

In September 2020, Genmab commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab. Under the license agreement, Genmab is, among other things, entitled to royalties from Janssen on sales of daratumumab (marketed as DARZALEX for intravenous administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for SC administration). The arbitration first 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 SC formulation of daratumumab. The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of SC daratumumab sales. 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 beginning in the second quarter of 2020 and has continued to do so through June 30, 2021. Given the ongoing arbitration, Genmab has reflected this reduction in its royalty revenues each quarter. The impact to the first half of 2021 royalties is estimated to be DKK 146 million. The impact to the first half of 2020 royalties is not material. The arbitration is also to settle 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 the product, as further defined and described in the license agreement.


The table below summarizes Genmab’s revenue by type and collaboration partner under Genmab’s agreements. This information provides the reader additional information regarding the nature, amount, timing and uncertainty of Genmab’s revenue and how cash flows might be affected by economic factors.

    

6 Months Ended

    

6 Months Ended

June 30, 2021

June 30, 2020

(DKK million)

Revenue by type:

 

 

  

Royalties

 

2,595

 

1,738

Reimbursement revenue

 

227

 

175

Milestone revenue

 

731

 

32

License revenue

 

 

4,398

Total

 

3,553

 

6,343

Revenue by collaboration partner:

 

 

Janssen

 

2,846

 

1,652

AbbVie

 

245

 

4,398

Roche

162

83

Seagen