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 NOVEMBER 2023


COMMISSION FILE NUMBER 001-38976

Genmab A/S
(Exact name of Registrant as specified in its charter)

Carl Jacobsens Vej 30

2500 Valby

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 

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, 333-232693 and 333-262970) 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: November 7, 2023


EXHIBIT INDEX

A

Exhibit

Description of Exhibit

99.1

Interim Report Dated November 7, 2023  


Interim Report for the 6 months ended June 30, 2011

Exhibit 99.1

Graphic

Genmab Announces Financial Results for the First Nine Months of 2023

November 7, 2023 Copenhagen, Denmark;

Interim Report for the First Nine Months Ended September 30, 2023

Highlights

Epcoritamab (TEPKINLY®) was granted conditional marketing authorization by the European Commission (EC) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Epcoritamab (EPKINLY) was approved by the Japan Ministry of Health, Labour and Welfare to treat adults with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
Genmab and Seagen Inc. (Seagen) announced that the Phase 3 innovaTV 301 confirmatory trial of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer met its primary endpoint of improved overall survival (OS) at a predetermined, independent interim analysis
Genmab revenue increased 26% compared to the first nine months of 2022, to DKK 11,796 million
Genmab 2023 financial guidance updated

“With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY is the first Genmab-owned medicine to become available to patients outside of the United States. In addition to being an important milestone for Genmab, these approvals mark an important milestone for patients in these territories who are in need of alternative therapeutic options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to continue to work with our partner, AbbVie Inc. (AbbVie), to further explore epcoritamab as a potential future core therapy across B-cell malignancies.”

Financial Performance First Nine Months of 2023

Net sales of DARZALEX® by Janssen Biotech, Inc. (Janssen) were USD 7,194 million in the first nine months of 2023 compared to USD 5,894 million in the first nine months of 2022, an increase of USD 1,300 million, or 22%.
Royalty revenue was DKK 9,803 million in the first nine months of 2023 compared to DKK 8,207 million in the first nine months of 2022, an increase of DKK 1,596 million, or 19%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta®, partly offset by negative foreign exchange rate impacts due to a lower average exchange rate between the USD and DKK.
Revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368 million for the first nine months of 2022. The increase of DKK 2,428 million, or 26%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis Pharma AG (Novartis), respectively, a milestone achieved under our collaboration with AbbVie for the first commercial sale of EPKINLY in the United States, and higher reimbursement revenue driven by increased activities under our collaboration with BioNTech SE (BioNTech).
Operating expenses were DKK 8,045 million in the first nine months of 2023 compared to DKK 5,676 million in the first nine months of 2022. The increase of DKK 2,369 million, or 42%, was driven by the expansion of our product pipeline, EPKINLY launch in the U.S., the continued

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 44

Carl Jacobsens Vej 30

www.genmab.com

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2500 Valby, Denmark

CVR no. 2102 3884


Graphic

Genmab Announces Financial Results for the First Nine Months of 2023

development of Genmab’s broader organizational capabilities, and related increase in team members to support these activities.
Operating profit was DKK 3,651 million in the first nine months of 2023 compared to DKK 3,692 million in the first nine months of 2022.
Net financial items resulted in income of DKK 1,060 million for the first nine months of 2023 compared to DKK 2,681 million in the first nine months of 2022. The decrease of DKK 1,621 million, or 60%, was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab’s USD denominated cash and cash equivalents, and marketable securities in the respective periods.

Outlook

Genmab is updating the lower end of its revenue and operating expenses of its 2023 financial guidance driven by higher total royalty revenues from DARZALEX and other marketed products and increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

  

 

 

 

 

 

 

 

Revised 

 

Previous 

 

(DKK million) 

Guidance 

Guidance 

Revenue 

15,900 - 16,500

15,500 - 16,500

Operating expenses 

(10,600) - (10,900)

(10,400) - (10,900)

Operating profit* 

4,800 – 5,750

4,500 - 6,000

*Operating profit includes DKK~0.2 billion of cost of product sales, which is not classified within operating expenses

Conference Call

Genmab will hold a conference call in English to discuss the results for the first nine months of 2023 today, Tuesday, November 7, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BIa45c5d7cd5384835a879e0ab083d0577. 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 Communications & Corporate Affairs

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

Andrew Carlsen, Vice President, Head of Investor Relations

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

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 44

Carl Jacobsens Vej 30

www.genmab.com

Page 2/40

2500 Valby, Denmark

CVR no. 2102 3884


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Interim Report for the First Nine Months of 2023

CONTENTS

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 44

Carl Jacobsens Vej 30

www.genmab.com

Page 3/40

2500 Valby, Denmark

CVR no. 2102 3884


Graphic

Interim Report for the First Nine Months of 2023

CONSOLIDATED KEY FIGURES

  

Three Months Ended

Nine Months Ended

(DKK million)

September 30, 

September 30, 

Full Year

Income Statement

2023

2022

2023

2022

2022

Revenue

 

4,744

4,087

11,796

9,368

14,595

Cost of product sales

(100)

(100)

Research and development expenses

 

(2,088)

(1,486)

(5,682)

(3,921)

(5,562)

Selling, general and administrative expenses

 

(839)

(670)

(2,363)

(1,755)

(2,676)

Operating expenses

 

(2,927)

(2,156)

(8,045)

(5,676)

(8,238)

Operating profit

 

1,717

1,931

3,651

3,692

6,357

Net financial items

 

985

1,341

1,060

2,681

678

Net profit

 

2,129

2,582

3,712

4,938

5,522

Balance Sheet

 

Marketable securities

 

13,252

13,411

13,252

13,411

12,431

Cash and cash equivalents

14,273

10,377

14,273

10,377

9,893

Total non-current assets

 

2,211

1,947

2,211

1,947

1,901

Total assets

 

35,238

30,686

35,238

30,686

30,278

Shareholders’ equity

 

31,112

26,657

31,112

26,657

27,441

Share capital

 

66

66

66

66

66

Cash Flow Statement

 

Cash flow from operating activities

 

2,037

1,968

5,708

3,514

3,912

Cash flow from investing activities

 

1,008

(1,382)

(840)

(2,625)

(2,761)

Cash flow from financing activities

 

20

(642)

(584)

(920)

(789)

Investment in intangible assets

(10)

Investment in tangible assets

 

(98)

(82)

(299)

(207)

(317)

Financial Ratios and Other Information

 

 

Basic net profit per share

 

32.60

39.55

56.84

 

75.48

84.45

Diluted net profit per share

 

32.32

39.17

56.35

 

74.83

83.65

Period-end share market price

 

2,508

2,461

2,508

 

2,461

2,941

Price / book value

 

5.32

6.09

5.32

 

6.09

7.07

Shareholders’ equity per share

 

471.39

403.89

471.39

 

403.89

415.77

Equity ratio

 

88

%

87

%

88

%

87

%

91

%

Shares outstanding

66,067,481

65,829,282

66,067,481

65,829,282

65,961,573

Average number of employees (FTE*)

 

2,096

1,516

1,953

 

1,402

1,460

Number of employees (FTE) at the end of the period

 

2,132

1,560

2,132

 

1,560

1,660

* Full-time equivalent or team members

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 44

Carl Jacobsens Vej 30

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2500 Valby, Denmark

CVR no. 2102 3884


Graphic

Interim Report for the First Nine Months of 2023

OUTLOOK

Revised

Previous

(DKK million)

Guidance

    

Guidance

Revenue

15,900 - 16,500

 

15,500 - 16,500

Operating expenses

(10,600) - (10,900)

 

(10,400) - (10,900)

Operating profit*

4,800 - 5,750

 

4,500 - 6,000

*Operating profit includes DKK~0.2 billion of cost of product sales, which is not classified within operating expenses

Genmab is updating the lower end of its revenue and operating expenses of its 2023 financial guidance driven by higher total royalty revenues from DARZALEX and other marketed products and increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Revenue

Genmab expects its 2023 revenue to be in the range of DKK 15,900 – 16,500 million, an increase to the previous guidance of DKK 15,500 – 16,500 million, driven by higher total royalty revenues from DARZALEX and other marketed products. DARZALEX royalties of DKK 11.3 – 11.5 billion are based on Genmab’s estimate of DARZALEX 2023 net sales of USD 9.8 – 10.0 billion.

Operating Expenses

Genmab anticipates its 2023 operating expenses to be in the range of DKK 10,600 – 10,900 million, an increase to the previous guidance of DKK 10,400 – 10,900 million, primarily related to increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Operating Profit

Genmab now expects its 2023 operating profit to be in the range of DKK 4,800 – 5,750 million, compared to the previous guidance of DKK 4,500 – 6,000 million, driven primarily by the items described above.

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; the timing and variation of development activities (including activities carried out by Genmab’s collaboration partners) and related income and costs; DARZALEX, DARZALEX FASPRO®, Kesimpta, TEPEZZA®, RYBREVANT®, TECVAYLI® and TALVEY® net sales and royalties paid to Genmab; changing rates of inflation; and currency exchange rates (the 2023 guidance assumes a USD / DKK exchange rate of 6.8). The financial guidance assumes that no significant new agreements are entered into during the remainder of 2023 that could materially affect the results. Refer to the section “Significant Risks and Uncertainties” in this interim report for matters that may cause Genmab’s actual results to differ materially from 2023 Guidance and Key 2023 Priorities in this interim report.

The factors discussed above, as well as other factors that are currently unforeseeable, may result in further and other unforeseen material adverse impacts on Genmab’s business and financial performance, including on the sales of Tivdak and EPKINLY/TEPKINLY, and on the net sales of DARZALEX, Kesimpta, TEPEZZA, RYBREVANT, TECVAYLI and TALVEY by Genmab’s collaboration partners and on Genmab’s royalties, collaboration revenue and milestone revenue therefrom.

Genmab A/S

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Carl Jacobsens Vej 30

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Graphic

Interim Report for the First Nine Months of 2023

KEY 2023 PRIORITIES

Bring Our Own Medicines to Patients

Epcoritamab1

Launch in relapsed/refractory DLBCL
Submit a Supplemental Biologics License Application (sBLA)2 
Broaden clinical development program

Tivdak3

Progress successful uptake in second line+ recurring or metastatic cervical cancer patients
Progress clinical development program

Build World-class Differentiated Pipeline   

DuoBody-CD40x4-1BB4

Establish efficacy and safety data in solid tumor indication
Progress towards late-stage clinical development

DuoBody-PD-L1x4-1BB4

Establish proof of concept data in solid tumor indication

Expand and advance proprietary clinical 
product portfolio

Invest in Our People & Culture

Further scale organization aligned with 
differentiated antibody product portfolio 
growth and future launches

Become a Leading Integrated Biotech

Innovation Powerhouse

Use solid financial base to grow and broaden antibody product and technology portfolio

1. Co-development w/ AbbVie; 2. Subject to supportive U.S. FDA feedback; 3. Co-development w/ Seagen; 4. Co-development w/ BioNTech

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2023

At the end of the first nine months of 2023, Genmab’s proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of nine antibodies in clinical development. These include Genmab’s approved medicines, Tivdak, which Genmab is co-developing globally and co-promoting in the U.S. in collaboration with Seagen and EPKINLY/TEPKINLY, which Genmab is co-developing and co-commercializing in the U.S. and Japan in collaboration with AbbVie. In addition to our own pipeline, there are multiple investigational medicines in development by global pharmaceutical and biotechnology companies, including five approved medicines powered by Genmab’s technology and innovations. Beyond the investigational medicines in clinical development, our pipeline also includes multiple pre-clinical programs. An overview of the development status of our approved medicines and of each of our investigational medicines is provided in the following section, including updates for the third quarter of 2023. For events that occurred during the first and second quarters of 2023, please refer to Genmab’s Q1 2023 and Genmab’s Q2 2023 Interim Reports, respectively. 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 A/S (Nasdaq Copenhagen)

Genmab A/S

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Interim Report for the First Nine Months of 2023

stock exchange and may also be found in Genmab’s filings with the U.S. Securities and Exchange Commission (U.S. SEC). Additional information is available on Genmab’s website, www.genmab.com. The information accessible through our website is not part of this report and is not incorporated by reference herein.

Genmab Proprietary Products1

Approved Medicines

Approved Product

Target

Developed By

Disease Indication

Tivdak

(tisotumab vedotin-tftv)

Tissue factor (TF)

Co-development Genmab/Seagen

Approved in the U.S. for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy2

EPKINLY

(epcoritamab-bysp, epcoritamab)

TEPKINLY

(epcoritamab)

CD3xCD20

Co-development

Genmab/AbbVie

Approved in the U.S. and Europe for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy and in Japan for adult patients with certain types of relapsed or refractory LBCL after two or more lines of systemic therapy2

1Approved and investigational medicines where Genmab has ≥50% ownership, in co-development with partners as indicated.
2Refer to relevant local prescribing information for precise indication and safety information.

Genmab A/S

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Interim Report for the First Nine Months of 2023

Pipeline, Including Further Development for Approved Medicines

Graphic

3Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen.

Tivdak (tisotumab vedotin-tftv) – First and only U.S. FDA approved antibody-drug conjugate (ADC) for recurrent or metastatic cervical cancer

An ADC directed to TF, a protein highly prevalent in solid tumors, including cervical cancer, which is associated with poor prognosis
Accelerated approval granted by the U.S. FDA for tisotumab vedotin-tftv, marketed as Tivdak, as the first and only approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
U.S. FDA approval was based on data from the innovaTV 204 (NCT03438396) clinical trial
In addition to a confirmatory Phase 3 trial in recurrent or metastatic cervical cancer (innovaTV 301, NCT04697628), clinical trials in other solid tumors are ongoing
Co-developed globally and co-promoted in the U.S. in collaboration with Seagen

Tisotumab vedotin is an ADC composed of Genmab’s human monoclonal antibody directed to TF and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E to the antibody. Genmab used technology licensed from Medarex Inc. (Medarex) to generate the TF antibody forming part of tisotumab vedotin. Tisotumab vedotin-tftv, marketed as Tivdak, is the first and only U.S. FDA approved ADC for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin is being co-developed by Genmab and Seagen. Under a joint commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and will lead commercial operational activities in Japan. Seagen is leading commercial operational activities in the U.S. and will lead commercial operational activities in Europe and China. In these four markets there will be a 50:50

Genmab A/S

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Interim Report for the First Nine Months of 2023

cost and profit split. In other markets, Seagen will commercialize Tivdak and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties. The companies have joint decision-making power on the worldwide development and commercialization strategy for Tivdak. The companies have a number of additional ongoing clinical trials for Tivdak, including a confirmatory Phase 3 trial in recurrent or metastatic cervical cancer, which met its primary endpoint of improved OS at predetermined, independent interim analysis in September 2023.

Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety information, including the boxed warning.

Third Quarter 2023 Update

September: The Phase 3 innovaTV 301(ENGOT cx-12/GOG 3057) global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received tisotumab vedotin, compared with chemotherapy alone, met its primary endpoint of OS at predetermined, independent interim analysis. The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of tisotumab vedotin in innovaTV 301 is consistent with the known safety profile of Tivdak as presented in the U.S. prescribing information, and no new safety signals were observed. The results of the trial add to the previous results of innovaTV 204, which served as the basis for the accelerated approval of Tivdak in the U.S. Subject to discussions with regulatory authorities, the results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support other regulatory applications.

EPKINLY/TEPKINLY (epcoritamab) – Approved in U.S., Europe and Japan

Bispecific antibody-based medicine created with Genmab’s DuoBody technology
Accelerated approval granted by the U.S. FDA for epcoritamab-bysp, marketed as EPKINLY, as the first T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade Bcell lymphoma, after two or more lines of systemic therapy
Conditional marketing authorization granted by the EC for epcoritamab, marketed as TEPKINLY, as the first and only subcutaneous (SC) bispecific antibody approved as a monotherapy for the treatment of adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy
Approval granted by the Japan Ministry of Health, Labour and Welfare for epcoritamab, marketed as EPKINLY, as the first and only bispecific antibody approved in Japan to treat adult patients with certain types of relapsed or refractory LBCL, including DLBCL, high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy
Regulatory approvals were based on data from the pivotal EPCORE NHL-1 (NCT03625037) clinical trial. Approval in Japan was also based on the EPCORE NHL-3 (NCT04542824) clinical trial
Multiple ongoing clinical trials across different settings and histologies, such as Phase 3 trials in DLBCL, including a confirmatory trial and an ongoing trial in newly diagnosed DLBCL (EPCORE DLBCL-1, NCT04628494 and EPCORE DLBCL-2, NCT05578976) and a confirmatory trial in relapsed/refractory FL (EPCORE FL-1, NCT05409066) with more trials in planning
Co-developed and co-commercialized in collaboration with AbbVie

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Interim Report for the First Nine Months of 2023

Epcoritamab is a proprietary bispecific antibody created using Genmab’s DuoBody technology platform. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically validated target on malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab. Epcoritamab is marketed as EPKINLY in the U.S. and will be in Japan, and as TEPKINLY in Europe. See local prescribing information for precise indications. In 2020, Genmab entered into a collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab will record sales in the U.S. and Japan and receive tiered royalties on remaining global sales outside of these territories. The companies have a broad clinical development program for epcoritamab including three ongoing Phase 3 trials and additional trials in planning.

Please consult the U.S. Prescribing Information for EPKINLY and the European Summary of Product Characteristics for TEPKINLY for the labeled indication and safety information.

Third Quarter 2023 Updates

September: The EC granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. TEPKINLY is the first and only SC T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as Liechtenstein, Norway and Iceland.
September: The Japan Ministry of Health, Labour and Welfare approved EPKINLY (epcoritamab) as the first and only T-cell engaging bispecific antibody treatment in Japan for the treatment of adult patients with certain types of relapsed or refractory LBCL, including DLBCL, HBCL, PMBCL and FL3B, after two or more lines of systemic therapy.

GEN1046 (BNT311) – Bispecific next-generation immunotherapy

Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology targeting PD-L1, 4-1BB
Clinical trials in solid tumors ongoing, including a Phase 2 trial in NSCLC (NCT05117242) and a Phase 2 trial in endometrial cancer (NCT06046274)
Co-developed in collaboration with BioNTech

GEN1046 (DuoBody-PD-L1x4-1BB, BNT311) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for GEN1046 on a 50:50 basis. GEN1046 is designed to induce an antitumor immune response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation using an inert DuoBody format. Three clinical trials in solid tumors are ongoing, including a Phase 2 trial of GEN1046 as monotherapy or in combination with pembrolizumab in patients with recurrent metastatic NSCLC. An additional Phase 2 trial of GEN1046 in combination with pembrolizumab for the treatment of advanced endometrial cancer has also been initiated.

Third Quarter 2023 Update

September: A Phase 2 open-label trial to determine the safety and preliminary activity of GEN1046 in combination with pembrolizumab in patients with advanced endometrial cancer was initiated.

Genmab A/S

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Carl Jacobsens Vej 30

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2500 Valby, Denmark

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Interim Report for the First Nine Months of 2023

GEN1042 (BNT312) – Potential first-in-class bispecific agonistic antibody

Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology targeting CD40, 4-1BB
Phase 1/2 clinical trials in solid tumors ongoing (NCT04083599, NCT05491317)
Co-developed in collaboration with BioNTech


GEN1042 (DuoBody-CD40x4-1BB, BNT312) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology platform. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for GEN1042 on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells and antigen-dependent T-cell activation, using an inert DuoBody format. Phase 1/2 clinical trials of GEN1042 in solid tumors are ongoing.

GEN3014 – HexaBody-based investigational medicine with potential in hematological malignancies

Antibody-based investigational medicine created with Genmab’s HexaBody technology targeting CD38
Phase 1/2 clinical trial in relapsed/refractory multiple myeloma and other hematological malignancies ongoing (NCT04824794)
Developed in an exclusive worldwide license and option agreement with Janssen

GEN3014 (HexaBody-CD38) is a human CD38 monoclonal antibody-based investigational medicine created using Genmab’s HexaBody technology platform. In pre-clinical models of hematological malignancies, GEN3014 demonstrated highly potent complement-dependent cytotoxicity and showed potent anti-tumor activity. In June 2019, Genmab entered into an exclusive worldwide license and option agreement with Janssen to develop and commercialize GEN3014. A Phase 1/2 clinical trial in hematologic malignancies is ongoing and includes an arm comparing GEN3014 to daratumumab in anti-CD38 monoclonal antibody-naïve relapsed or refractory multiple myeloma patients.

GEN3009

Antibody-based investigational medicine created with Genmab’s DuoHexaBody technology targeting CD37
The program has been discontinued due to strategic evaluation within the context of Genmab’s portfolio

GEN3009 (DuoHexaBody-CD37) is a bispecific antibody that targets two non-overlapping CD37 epitopes, created using Genmab’s DuoHexaBody technology platform. The DuoHexaBody technology platform combines the dual targeting of our DuoBody technology platform with the enhanced potency of our HexaBody technology platform, creating bispecific antibodies with target-mediated enhanced hexamerization. The GEN3009 program, including the Phase 1/2 trial in B-cell NHLs (NCT04358458) was discontinued in the third quarter of 2023 due to a strategic evaluation of GEN3009 within the context of Genmab’s portfolio. The decision was not based on safety or regulatory concerns.

GEN1047 – Bispecific antibody with potential in solid tumors

Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology targeting CD3, B7H4

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Phase 1/2 clinical trial in malignant solid tumors ongoing (NCT05180474)

GEN1047 (DuoBody-CD3xB7H4) is a bispecific antibody-based investigational medicine created using Genmab’s DuoBody technology platform. B7H4 is an immune checkpoint protein expressed on malignant cells in various solid cancers including breast, ovarian and lung cancer. In pre-clinical studies, GEN1047 induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. GEN1047 is being developed for the potential treatment of solid cancer indications known to express B7H4. A Phase 1/2 clinical trial of GEN1047 in malignant solid tumors is ongoing.

GEN1053 (BNT313) – HexaBody-based investigational medicine with potential in solid tumors

Antibody-based investigational medicine created with Genmab’s HexaBody technology targeting CD27
Phase 1/2 clinical trial in solid tumors ongoing (NCT05435339)
Co-developed in collaboration with BioNTech

GEN1053 (HexaBody-CD27, BNT313) is a CD27 antibody that utilizes Genmab’s HexaBody technology, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of T cells. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for GEN1053 on a 50:50 basis. A Phase 1/2 clinical trial of GEN1053 in solid tumors is ongoing.

GEN1056 (BNT322) – First-in-human trial recruiting

Phase 1 clinical trial in solid tumors ongoing (NCT05586321)
Co-developed in collaboration with BioNTech

GEN1056 (BNT322) is an antibody product being co-developed by Genmab and BioNTech for the treatment of solid tumors and for use in combination with other products. A first-in-human Phase 1 clinical trial of GEN1056 in patients with advanced solid tumors is ongoing.

GEN3017 –DuoBody-based investigational therapy in the clinic

Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology targeting CD3, CD30
Phase 1 clinical trial in relapsed or refractory classical Hodgkin lymphoma and NHL ongoing (NCT06018129)

GEN3017 (DuoBody-CD3xCD30) is a bispecific antibody-based investigational medicine created using Genmab’s DuoBody technology platform. CD30 is highly expressed in multiple hematologic malignancies, including classical Hodgkin lymphoma and anaplastic large cell lymphoma. In pre-clinical studies, GEN3017 induced potent T-cell mediated cytotoxicity of CD30-expressing tumor cells in vitro, which was associated with induction of CD4+ and CD8+ T-cell activation, proliferation and cytokine production. GEN3017 is being developed for the potential treatment of certain hematological malignancies. A Phase 1/2 clinical trial of GEN3017 in relapsed or refractory classical Hodgkin lymphoma and NHL is ongoing.

Pre-clinical Programs

Broad pre-clinical pipeline that includes both partnered products and in-house programs based on our proprietary technologies and/or antibodies
Multiple new Investigational New Drug (IND) applications expected to be submitted over coming years

Genmab A/S

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Interim Report for the First Nine Months of 2023

Genmab has entered multiple strategic collaborations to support the expansion of our innovative pipeline

Our pre-clinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody technology platform and bispecific antibodies created with our DuoBody technology platform. We are also working with our partners to generate additional new antibody-based product concepts. A number of the pre-clinical programs are carried out in cooperation with our collaboration partners.

Third Quarter 2023 Update

August: An IND was submitted for GEN1059/BNT314 (DuoBody-EpCAMx4-1BB), which is being co-developed by Genmab and BioNTech.

Programs Powered by Genmab’s Technology and Innovations

In addition to Genmab’s own pipeline of investigational medicines, our innovations and proprietary technology platforms are applied in the pipelines of global pharmaceutical and biotechnology companies. These companies are running clinical development programs with antibodies created by Genmab or created using Genmab’s proprietary DuoBody bispecific antibody technology platform. The programs run from Phase 1 development to approved medicines. The tables in this section include those therapies that have been approved in certain territories as well as clinical stage investigational medicines in Phase 2 development or later. Under the agreements for these products Genmab is entitled to certain potential milestones and royalties.

Approved Medicines

Approved Product

Discovered and/or Developed & Marketed By

Disease Indication(s)

DARZALEX

(daratumumab)/DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)

Janssen (Royalties to Genmab on net global sales)

Multiple myeloma1

Light-chain (AL) Amyloidosis1

Kesimpta

(ofatumumab)

Novartis (Royalties to Genmab on net global sales)

Relapsing multiple sclerosis (RMS)1

TEPEZZA

(teprotumumab-trbw)

Amgen Inc. (Amgen)2 (under sublicense from Roche, royalties to Genmab on net global sales)

Thyroid eye disease (TED)1

RYBREVANT

(amivantamab/amivantamab-vmjw)

Janssen (Royalties to Genmab on net global sales)

NSCLC1

TECVAYLI

(teclistamab/teclistamab-cqyv)

Janssen (Royalties to Genmab on net global sales)

Relapsed and refractory multiple myeloma1

TALVEY

(talquetamab/talquetamab-tgvs)

Janssen (Royalties to Genmab on net global sales)

Relapsed and refractory multiple myeloma1

1See local prescribing information for precise indication and safety information; Previously Horizon Therapeutics plc (Horizon), acquired by Amgen in October 2023.

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Interim Report for the First Nine Months of 2023

≥ Phase 2 Development, Including Further Development for Approved Medicines

Graphic

2UltiMAb transgenic mouse technology licensed from Medarex, a wholly owned subsidiary of Bristol Myers Squibb.

DARZALEX (daratumumab) – Redefining the treatment of multiple myeloma

First-in-class human CD38 monoclonal antibody
Developed and commercialized by Janssen under an exclusive worldwide license from Genmab
Intravenous (IV) product approved in combination with other therapies and as monotherapy for certain multiple myeloma indications
First and only SC CD38-directed antibody approved for the treatment of certain multiple myeloma indications, known as DARZALEX FASPRO (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., Europe and Japan
Net sales of DARZALEX by Janssen were USD 7,194 million in the first nine months of 2023

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. Genmab used technology licensed from Medarex to generate the CD38 antibody. Daratumumab is being developed and commercialized by Janssen under an exclusive worldwide license from Genmab. Under the terms of the agreement, Genmab will receive double digit royalties between 12% and 20% with Janssen reducing such royalty payments for Genmab’s share of Janssen’s royalty payments made to Halozyme. Daratumumab (marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for SC administration) is approved in a large number of territories for the treatment of adult patients with certain multiple myeloma indications and is the only approved therapy in the U.S., Europe and Japan for the treatment of adult patients with AL amyloidosis.

Please consult the European Summary of Product Characteristics for DARZALEX and DARZALEX SC and the U.S. Prescribing Information for DARZALEX and DARZALEX FASPRO for the labeled indication and safety information.

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 44

Carl Jacobsens Vej 30

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Interim Report for the First Nine Months of 2023

Kesimpta (ofatumumab) – Approved for the treatment of RMS

Human CD20 monoclonal antibody developed and commercialized by Novartis under a license agreement with Genmab
Approved in territories including the U.S., EU and Japan for the treatment of 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. Ofatumumab, marketed as Kesimpta, is approved in territories including the U.S., Europe and Japan for the treatment of certain adult patients with RMS. Kesimpta is the first B-cell therapy that can be self-administered by patients at home using the Sensoready autoinjector pen, once monthly after starting therapy. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis. Under the terms of the agreement, Genmab will receive 10% royalties on net sales of Kesimpta.

Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for the labeled indication and safety information for Kesimpta.

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

Development and commercialization by Amgen for the treatment of TED
First and only U.S. FDA-approved medicine for the treatment of TED
Also being explored in a clinical trial for the treatment of diffuse cutaneous systemic sclerosis (dcSSC)

Teprotumumab-trbw, approved by the U.S. FDA under the trade name TEPEZZA, is a human monoclonal antibody that targets the Insulin-like Growth Factor 1 Receptor (IGF-1R), a validated target. Genmab used technology licensed from Medarex to generate the IGF-1R antibody. The antibody was created by Genmab under a collaboration with Roche. Development and commercialization of the product was subsequently conducted by Horizon under a sublicense from Roche. In October 2023, Amgen completed its acquisition of Horizon, including all commercialization and development of teprotumumab. Under the terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on net sales of TEPEZZA.

Please consult the U.S. Prescribing Information for the labeled indication and safety information for TEPEZZA.

RYBREVANT (amivantamab) – First regulatory approvals for a DuoBody-based medicine

Part of Genmab and Janssen DuoBody research and license agreement
First approved medicine created using Genmab’s proprietary DuoBody technology
Under the agreement with Janssen, Genmab is eligible to receive milestones and receives royalties on net sales of RYBREVANT

In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of these, Janssen’s amivantamab, is a fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and cMet, two validated cancer targets. The two antibody libraries used to produce amivantamab were both generated

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Interim Report for the First Nine Months of 2023

by Genmab. In collaboration with Janssen, the antibody pair used to create amivantamab was selected. Janssen is responsible for the development and commercialization of amivantamab.

In 2021, Janssen received approvals in the U.S., Europe and other markets for amivantamab, marketed as RYBREVANT, for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations. These were the first regulatory approvals for a therapy that was created using Genmab’s proprietary DuoBody bispecific technology platform. Under our agreement with Janssen, Genmab is eligible to receive milestones and receives royalties between 8% and 10% on net sales of RYBREVANT.

Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for RYBREVANT for the labeled indication and safety information.

TECVAYLI (teclistamab) – Bispecific antibody approved for the treatment of relapsed and refractory multiple myeloma

Part of Genmab and Janssen DuoBody research and license agreement
Second approved medicine created using Genmab’s proprietary DuoBody technology
Under the agreement with Janssen, Genmab is eligible to receive milestones and receives royalties on net sales of TECVAYLI

In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of the products subsequently discovered and developed by Janssen is teclistamab, a bispecific antibody that targets CD3, which is expressed on T-cells and B-cell maturation antigen (BCMA), which is expressed in mature B lymphocytes.

In August 2022, Janssen received conditional marketing authorization from the EC for subcutaneously administered teclistamab, marketed as TECVAYLI, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. In October 2022, Janssen received U.S. FDA approval of TECVAYLI (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Under our agreement with Janssen, Genmab is eligible to receive milestones and receives a mid-single digit royalty on net sales of TECVAYLI.

Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for TECVAYLI for the labeled indication and safety information.

TALVEY (talquetamab) – Bispecific antibody approved for the treatment of relapsed and refractory multiple myeloma

Part of Genmab and Janssen DuoBody research and license agreement
Fourth approved medicine created using Genmab’s proprietary DuoBody technology
Under the agreement with Janssen, Genmab will receive milestones and royalties on net sales of TALVEY

In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. One of the products subsequently discovered

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Interim Report for the First Nine Months of 2023

and developed by Janssen is talquetamab, a bispecific antibody that targets CD3, which is expressed on T-cells and G protein-coupled receptor, family C, group 5, member D (GPRC5D), an orphan receptor expressed in malignant plasma cells.

In August 2023, Janssen received accelerated approval from the U.S. FDA for subcutaneously administered talquetamab-tgvs, marketed as TALVEY, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Subsequently Janssen received conditional marketing authorization from the EC for TALVEY for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Under our agreement with Janssen, Genmab will receive milestones and a mid-single digit royalty on net sales of TALVEY.

Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for TALVEY for the labeled indication and safety information.

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, commercialization and financial activities. For further information about risks and uncertainties which Genmab faces, refer to the 2022 Annual Report filed with NASDAQ Copenhagen and the Form 20-F filed with the U.S. SEC, both of which were filed in February 2023. At the date of this interim report, there have been no significant changes to Genmab’s overall risk profile since the publication of these reports. See Genmab’s Form 20-F for a detailed summary of risks related to our collaborations.

FINANCIAL REVIEW

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

Genmab received regulatory approvals during 2023 for epcoritamab marketed as EPKINLY in the U.S. and Japan, and TEPKINLY in Europe. EPKINLY/TEPKINLY is the first Genmab-owned medicine to become available to patients outside of the United States.

Revenue

Genmab’s revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368 million for the first nine months of 2022. The increase of DKK 2,428 million, or 26%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis, respectively, a milestone achieved under our collaboration with AbbVie for the first commercial sale of EPKINLY in the United States, and higher reimbursement revenue driven by increased activities under our collaboration agreements with BioNTech.

Genmab A/S

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Carl Jacobsens Vej 30

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Interim Report for the First Nine Months of 2023

    

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

(DKK million)

2023

2022

2023

2022

Royalties

 

3,868

 

3,480

9,803

 

8,207

Reimbursement revenue

 

306

 

307

789

 

594

Milestone revenue

 

342

 

112

797

 

288

Collaboration revenue

78

182

218

273

License revenue

6

6

Net product sales

150

189

Total revenue

 

4,744

 

4,087

11,796

 

9,368

Royalties

Royalty revenue amounted to DKK 9,803 million in the first nine months of 2023 compared to DKK 8,207 million in the first nine months of 2022. The increase of DKK 1,596 million, or 19%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our daratumumab collaboration with Janssen and ofatumumab collaboration with Novartis, respectively, partly offset by negative foreign exchange rate impacts due to a lower average exchange rate between the USD and DKK. The table below summarizes Genmab’s royalty revenue by product.

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

(DKK million)

2023

2022

2023

2022

DARZALEX

 

3,177

 

3,049

8,081

 

7,073

Kesimpta

449

213

1,049

509

TEPEZZA

 

180

 

207

516

 

597

Other

62

11

157

28

Total royalties

 

3,868

 

3,480

9,803

 

8,207

Net sales of DARZALEX by Janssen were USD 7,194 million in the first nine months of 2023 compared to USD 5,894 million in the first nine months of 2022. The increase of USD 1,300 million, or 22%, was driven by share gains in all regions. Royalty revenue on net sales of DARZALEX was DKK 8,081 million in the first nine months of 2023 compared to DKK 7,073 million in the first nine months of 2022, an increase of DKK 1,008 million. The percentage increase in royalties of 14% is lower than the percentage increase in the underlying net sales primarily due to a lower average exchange rate between the USD and DKK for the first nine months of 2023, other foreign exchange impacts and the increase in Genmab’s Halozyme royalty deductions in connection with the increase in SC product net sales. Under our license agreement with Janssen for DARZALEX, for purposes of calculating royalties due to Genmab, net sales for non-U.S. denominated currencies are translated to U.S. dollars at a specific annual Currency Hedge Rate. This contractual agreement is the driver for the other foreign exchange rate impacts discussed above, which were significantly more favorable in the first nine months of 2022 compared to the first nine months of 2023.

Net sales of Kesimpta by Novartis were USD 1,530 million in the first nine months of 2023 compared to USD 723 million in the first nine months of 2022. The increase of USD 807 million, or 112%, was primarily driven by increased demand, strong access, and benefiting from a one-time revenue adjustment in Europe. Royalty revenue on net sales of Kesimpta was DKK 1,049 million in the first nine months of 2023 compared to DKK 509 million in the first nine months of 2022, an increase of DKK 540 million, or 106%.

Genmab A/S

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Interim Report for the First Nine Months of 2023

Royalty revenue on estimated net sales of TEPEZZA was DKK 516 million in the first nine months of 2023 compared to DKK 597 million in the first nine months of 2022, a decrease of DKK 81 million, or 14%.

Janssen was granted approval for TECVAYLI for the treatment of relapsed or refractory multiple myeloma during the third quarter of 2022 in Europe and in the fourth quarter of 2022 in the U.S. Royalties were not material for the first nine months of 2023. There were no royalties for the first nine months of 2022.

During the third quarter of 2023, Janssen was granted approval in the U.S. and in Europe for TALVEY for the treatment of relapsed or refractory multiple myeloma. Royalties were not material for the first nine months of 2023.

Royalty revenue fluctuations from period to period are driven by the level of product net sales, foreign currency exchange rate movements and more specifically to DARZALEX, the contractual arrangement related to annual Currency Hedge Rate, and Genmab’s share of Janssen’s royalty payments to Halozyme in connection with SC product net sales.

Reimbursement Revenue

Reimbursement revenue amounted to DKK 789 million in the first nine months of 2023 compared to DKK 594 million in the first nine months of 2022. The increase of DKK 195 million, or 33%, was primarily driven by higher activities under our collaboration agreements with BioNTech for DuoBody-CD40x4-1BB and DuoBody-PD-L1x4-1BB.

Milestone Revenue

Milestone revenue was DKK 797 million in the first nine months of 2023 compared to DKK 288 million in the first nine months of 2022, an increase of DKK 509 million primarily driven by an AbbVie milestone achieved related to the first commercial sale of EPKINLY in the U.S. and Janssen milestones achieved related to approvals of TALVEY in the U.S. and Europe.

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.

Collaboration Revenue

Collaboration revenue was DKK 218 million in the first nine months of 2023 compared to DKK 273 million in the first nine months of 2022, a decrease of DKK 55 million, or 20%, driven by a one-off payment in the first nine months of 2022 from Seagen of approximately USD 15 million (DKK 112 million) which reflects Genmab’s share (50%) of payments received by Seagen in connection with the sublicense of its rights to develop and commercialize tisotumab vedotin in China to Zai Lab Hong Kong, partly offset by an increase in net sales of TIVDAK.

Net Product Sales

Following the approval of EPKINLY in the U.S. on May 19, 2023, Genmab recognized net product sales of DKK 189 million through September 30, 2023. As EPKINLY is Genmab’s first commercialized product for which Genmab is recording net product sales, there were no net product sales recognized during the first nine months of 2022.

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

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Interim Report for the First Nine Months of 2023

Cost of Product Sales

Genmab recognized cost of product sales of DKK 100 million following the approval of EPKINLY in the U.S. on May 19, 2023 through September 30, 2023. Cost of product sales related to EPKINLY sales is primarily comprised of profit-sharing amounts payable to AbbVie of DKK 90 million as well as product costs. There were no cost of product sales recognized during the first nine months of 2022.

Key Developments to Revenue – Third Quarter of 2023

Genmab’s revenue was DKK 4,744 million for the third quarter of 2023 compared to DKK 4,087 million for the third quarter of 2022. The increase of DKK 657 million, or 16%, was primarily driven by higher Kesimpta and DARZALEX royalties achieved under our collaborations with Novartis and Janssen, respectively, and milestones achieved under our collaboration with Janssen for the approvals of TALVEY in the U.S. and Europe, partly offset by negative foreign exchange rate impacts due to a lower average exchange rate between the USD and DKK.

Research and Development Expenses

Research and development expenses amounted to DKK 5,682 million in the first nine months of 2023 compared to DKK 3,921 million in the first nine months of 2022. The increase of DKK 1,761 million, or 45%, was driven by the increased and accelerated advancement of epcoritamab under our collaboration with AbbVie, increased activities of DuoBody-CD40x4-1BB and DuoBody-PD-L1x4-1BB under our collaboration with BioNTech, further progression of pipeline products, and the increase in team members to support the continued expansion of our product portfolio.

Research and development expenses accounted for 71% of total operating expenses in the first nine months of 2023 compared to 69% in the first nine months of 2022.

Key Developments to Research and Development Expenses – Third Quarter of 2023

No significant key developments other than the items described above.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were DKK 2,363 million in the first nine months of 2023 compared to DKK 1,755 million in the first nine months of 2022. The increase of DKK 608 million, or 35%, was driven by the continued expansion of Genmab’s commercialization capabilities through the increase in team members to support the launch of EPKINLY in the U.S., and the investment in Genmab’s broader organizational capabilities.

Selling, general and administrative expenses accounted for 29% of total operating expenses in the first nine months of 2023 compared to 31% for the first nine months of 2022.

Key Developments to Selling, General and Administrative Expenses – Third Quarter of 2023

No significant key developments other than the items described above.

Operating Profit

Operating profit was DKK 3,651 million in the first nine months of 2023 compared to DKK 3,692 million in the first nine months of 2022. Operating profit was DKK 1,717 million in the third quarter of 2023 compared to DKK 1,931 million in the third quarter of 2022.

Net Financial Items

Net financial items includes the following:

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Interim Report for the First Nine Months of 2023

    

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

(DKK million)

2023

2022

2023

2022

Interest and other financial income

 

243

97

644

184

Gain on marketable securities, net

69

158

Gain on other investments, net

4

Foreign exchange rate gain, net

 

714

1,456

275

3,248

Total financial income

 

1,026

1,553

1,081

 

3,432

Interest and other financial expenses

 

(8)

(6)

(21)

(16)

Loss on marketable securities, net

(140)

(455)

Loss on other investments, net

(33)

(66)

(280)

Total financial expenses

 

(41)

 

(212)

(21)

 

(751)

Net financial items

 

985

 

1,341

1,060

 

2,681

Interest Income

Interest income was DKK 644 million in the first nine months of 2023 compared to DKK 184 million in the first nine months of 2022. The increase of DKK 460 million was driven by higher effective interest rates in the U.S., Europe and Denmark, and higher cash and cash equivalents and marketable securities.

Foreign Exchange Rate Gains and Losses

Foreign exchange rate gain, net was DKK 275 million in the first nine months of 2023 compared to DKK 3,248 million in the first nine months of 2022. The USD strengthened against the DKK in the first nine months of 2023 and 2022, positively impacting our USD denominated securities and cash holdings, but to a greater extent in 2022.

    

September 30, 2023

December 31, 2022

September 30, 2022

December 31, 2021

USD/DKK Foreign Exchange Rates

7.0390

6.9722

7.6287

6.5612

% Increase from prior year-end

1.0%

16.3%

Marketable Securities Gains and Losses

Gain on marketable securities, net was DKK 158 million in the first nine months of 2023 compared to loss on marketable securities, net of DKK 455 million in the first nine months of 2022. The increase of DKK 613 million was primarily driven by interest rate outlooks for the U.S. and Europe.

Other Investments

Gain on other investments, net was DKK 4 million in the first nine months of 2023 compared to loss on other investments, net of DKK 280 million in the first nine months of 2022. The change was primarily due to the significant decrease in fair value of Genmab’s investment in common shares of CureVac impacting the first nine months of 2022.

Refer to Financial Statement Note 4 in this interim report for further details about the net financial items.

Key Developments to Net Financial Items – Third Quarter of 2023

No significant key developments other than the items described above.

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Corporate Tax

Corporate tax expense for the first nine months of 2023 was DKK 999 million compared to DKK 1,435 million for the first nine months of 2022. The decrease in corporate tax expense is primarily the result of Genmab’s lower net profit before tax and a decrease in the estimated annual effective tax rate in the first nine months of 2023 to 21.2% from 22.5% in the first nine months of 2022. The decrease in Genmab’s effective tax rate was mainly driven by the ability to realize unrecognized deferred tax assets.

Key Developments to Corporate Tax – Third Quarter of 2023

No significant key developments other than the items described above.

Net Profit

Net profit for the first nine months of 2023 was DKK 3,712 million compared to DKK 4,938 million in the first nine months of 2022. Net profit for the third quarter of 2023 was DKK 2,129 million compared to DKK 2,582 million in the third quarter of 2022. The decrease was driven by the items described above.

Liquidity and Capital Resources

(DKK million)

    

September 30, 2023

    

December 31, 2022

Marketable securities

 

13,252

 

12,431

Cash and cash equivalents

 

14,273

 

9,893

Shareholders' equity

 

31,112

 

27,441

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

Cash Flow (DKK million)

    

2023

    

2022

 

2023

    

2022

Cash provided by operating activities

 

2,037

 

1,968

5,708

 

3,514

Cash provided by (used in) investing activities

 

1,008

 

(1,382)

(840)

 

(2,625)

Cash provided by (used in) financing activities

20

(642)

(584)

(920)

Increase (decrease) in cash and cash equivalents

 

3,065

 

(56)

4,284

 

(31)

Exchange Rate adjustments

334

617

96

1,451

Net cash provided by operating activities is primarily related to our operating profit, changes in operating assets and liabilities, reversal of net financial items, and adjustments related to non-cash transactions. Cash provided by operating activities increased in the first nine months of 2023 compared to the first nine months of 2022 primarily driven by significant AbbVie milestones achieved with related cash received during the first nine months of 2023 and cash received for DARZALEX royalties as a result of increasing net sales.

Net cash (used in) investing activities primarily reflects differences between the proceeds received from the sale and maturity of our investments and amounts invested, and the cash paid for investments in tangible and intangible assets. The decrease in net cash (used in) investing activities is primarily driven by purchases of marketable securities exceeding sales and maturities to a greater extent during the first nine months of 2022 compared to the first nine months of 2023.

Net cash (used in) financing activities is primarily related to the purchase of treasury shares, exercise of warrants, lease payments, and payment of withholding taxes on behalf of employees on net settled Restricted Stock Units (RSUs). The decrease in net cash (used in) financing activities between the

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periods is primarily driven by cash payments for the purchase of treasury shares of DKK 564 million in the first nine months of 2023 compared to DKK 908 million for the first nine months of 2022.

Genmab’s USD denominated cash and cash equivalents, and marketable securities represented 89% of Genmab’s total cash and cash equivalents, and marketable securities as of September 30, 2023 compared to 86% as of December 31, 2022.

There were no short-term marketable securities classified as cash and cash equivalents as of September 30, 2023. Cash and cash equivalents included short-term marketable securities of DKK 594 million as of December 31, 2022. In accordance with our accounting policy, securities purchased with a maturity of less than ninety days 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.

Key Developments to Cash Flows – Third Quarter of 2023

No significant key developments other than the items described above.

Balance Sheet

As of September 30, 2023, total assets were DKK 35,238 million compared to DKK 30,278 million on December 31, 2022. As of September 30, 2023, assets were mainly comprised of marketable securities of DKK 13,252 million, cash and cash equivalents of DKK 14,273 million and current receivables of DKK 5,432 million. The current receivables consist primarily of amounts related to royalties from our collaboration agreements.

As of September 30, 2023, total liabilities were DKK 4,126 million compared to DKK 2,837 million on December 31, 2022. The increase in total liabilities of DKK 1,289 million, or 45%, was primarily driven by accruals related to the expansion of our product pipeline, and the increase in corporate tax payable due to Genmab’s net profit before tax and timing of estimated tax payments.

Shareholders’ equity as of September 30, 2023 was DKK 31,112 million compared to DKK 27,441 million on December 31, 2022. The increase of DKK 3,671 million, or 13%, was primarily driven by Genmab’s net profit for the period and share-based compensation expenses, partly offset by the purchase of treasury shares. Genmab’s equity ratio was 88% as of September 30, 2023 compared to 91% as of December 31, 2022.

Team Members

As of September 30, 2023, the total number of team members was 2,132 compared to 1,560 as of September 30, 2022. The increase was primarily driven by the expansion and acceleration of our pipeline, as well as the investment in the expansion of Genmab’s commercialization capabilities, including support for the launch of EPKINLY in the U.S. and Japan, and broader organizational capabilities.

Nine Months Ended

September 30, 

Team Members

    

2023

    

2022

Research and development team members

 

1,484

1,129

Selling, general and administrative team members

 

648

431

Total team members

 

2,132

 

1,560

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Legal Matters – Janssen Binding Arbitrations

In September 2020, Genmab commenced binding arbitration of two matters arising under its license agreement with Janssen relating to daratumumab. In April 2022, the arbitral tribunal issued an award in the binding arbitration of the two matters in favor of Janssen. Genmab did not seek a review of the award, and the award is now final.

On June 9, 2022, Genmab announced the commencement of a second arbitration under the daratumumab license agreement with Janssen with claims for milestone payments for daratumumab SC of USD 405 million and a separate 13-year royalty term for daratumumab SC on a country-by-country basis, from the date of the first commercial sale of daratumumab SC in each such country. This second arbitration followed from the award in the prior arbitration, where the tribunal ruled in favor of Janssen on the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme for its technology used in the daratumumab SC product. The tribunal based its ruling on the finding that DARZALEX FASPRO constitutes a new licensed product under the license agreement.

On April 21, 2023, the arbitral tribunal dismissed Genmab’s claims regarding the second arbitration, on the basis that these claims should have been brought in the first arbitration. One arbitrator dissented. Genmab has filed a request for review of the award. See Company Announcement nos. 24 and 25.

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STATEMENTS OF COMPREHENSIVE INCOME

Income Statement

    

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

Note

 

2023

2022

2023

2022

(DKK million)

 

Revenue

2

4,744

4,087

11,796

9,368

Cost of product sales

(100)

(100)

Research and development expenses

 

(2,088)

(1,486)

(5,682)

(3,921)

Selling, general and administrative expenses

 

(839)

(670)

(2,363)

(1,755)

Operating expenses

 

(2,927)

(2,156)

(8,045)

(5,676)

Operating profit

 

1,717

 

1,931

3,651

3,692

Financial income

4

 

1,026

1,553

1,081

3,432

Financial expenses

4

(41)

(212)

(21)

(751)

Net profit before tax

 

2,702

3,272

4,711

6,373

Corporate tax

 

(573)

(690)

(999)

(1,435)

Net profit

 

2,129

2,582

3,712

4,938

Basic net profit per share

 

32.60

39.55

56.84

75.48

Diluted net profit per share

 

32.32

39.17

56.35

74.83

Statement of Comprehensive Income

 

  

 

  

  

  

Net profit

 

2,129

2,582

3,712

4,938

Other comprehensive income:

  

 

  

 

  

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

  

 

  

 

  

Exchange differences on translation of foreign operations

30

41

44

70

Total comprehensive income

2,159

2,623

3,756

5,008

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BALANCE SHEETS

    

    

September 30, 

    

December 31, 

Note

2023

2022

(DKK million)

ASSETS

 

  

 

  

 

  

Intangible assets

 

  

 

115

 

146

Property and equipment

 

  

 

943

 

799

Right-of-use assets

 

7

 

708

 

523

Receivables

 

  

 

37

 

48

Deferred tax assets

 

  

 

252

 

252

Other investments

3

156

133

Total non-current assets

 

  

 

2,211

 

1,901

Corporate tax receivable

143

Inventories

70

Receivables

 

  

 

5,432

 

5,910

Marketable securities

 

3

 

13,252

 

12,431

Cash and cash equivalents

 

  

 

14,273

 

9,893

Total current assets

 

  

 

33,027

 

28,377

Total assets

 

  

 

35,238

 

30,278

SHAREHOLDERS’ EQUITY AND LIABILITIES

 

  

 

  

 

  

Share capital

 

  

 

66

 

66

Share premium

 

  

 

12,452

 

12,309

Other reserves

 

  

 

142

 

98

Retained earnings

 

  

 

18,452

 

14,968

Total shareholders' equity

 

  

 

31,112

 

27,441

Lease liabilities

 

7

 

710

 

523

Deferred revenue

2

480

480

Other payables

 

  

 

34

 

11

Total non-current liabilities

 

  

 

1,224

 

1,014

Corporate tax payable

445

Lease liabilities

 

7

 

83

 

74

Deferred revenue

2

33

33

Other payables

 

  

 

2,341

 

1,716

Total current liabilities

 

  

 

2,902

 

1,823

Total liabilities

 

  

 

4,126

 

2,837

Total shareholders' equity and liabilities

 

  

 

35,238

 

30,278

Share-based instruments

 

5

 

  

 

  

Related parties

 

6

 

  

 

  

Subsequent events to the balance sheet date

 

8

 

  

 

  

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STATEMENTS OF CASH FLOWS

Nine Months Ended

September 30, 

    

Note

    

2023

    

2022

(DKK million)

Net profit before tax

4,711

6,373

Reversal of financial items, net

(1,060)

(2,681)

Adjustments for non-cash transactions

670

574

Changes in operating assets and liabilities

1,204

(454)

Cash flows from operating activities before financial items

5,525

3,812

Interest received

612

169

Interest elements of lease payments

7

(18)

(11)

Interest paid

(1)

Corporate taxes paid

(411)

(455)

Net cash provided by operating activities

5,708

3,514

Investment in intangible assets

(10)

Investment in tangible assets

(299)

(207)

Marketable securities bought

(8,382)

(7,238)

Marketable securities sold

7,868

4,850

Other investments bought

(17)

(30)

Net cash (used in) investing activities

(840)

(2,625)

Warrants exercised

143

112

Principal elements of lease payments

(66)

(47)

Purchase of treasury shares

5

(564)

(908)

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

(97)

(77)

Net cash (used in) financing activities

(584)

(920)

Change in cash and cash equivalents

4,284

(31)

Cash and cash equivalents at the beginning of the period

9,893

8,957

Exchange rate adjustments

96

1,451

Cash and cash equivalents at the end of the period

14,273

10,377

Cash and cash equivalents include:

Bank deposits

14,273

9,082

Short-term marketable securities

1,295

Cash and cash equivalents at the end of the period

14,273

10,377

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STATEMENTS OF CHANGES IN EQUITY

    

Share

    

Share

    

Translation

    

Retained

    

Shareholders'

capital

premium

reserves

earnings

equity

(DKK million)

 

Balance at December 31, 2021

 

66

 

12,029

 

81

 

10,020

 

22,196

Net profit

 

4,938

 

4,938

Other comprehensive income

 

70

 

70

Total comprehensive income

 

 

 

70

 

4,938

 

5,008

Transactions with owners:

 

  

 

  

 

  

 

  

 

  

Exercise of warrants

 

112

 

112

Purchase of treasury shares

(908)

(908)

Share-based compensation expenses

326

326

Net settlement of RSUs

 

(77)

 

(77)

Balance at September 30, 2022

 

66

12,141

151

14,299

26,657

Balance at December 31, 2022

 

66

 

12,309

 

98

 

14,968

 

27,441

Net profit

 

3,712

 

3,712

Other comprehensive income

 

44

 

44

Total comprehensive income

 

 

 

44

 

3,712

 

3,756

Transactions with owners:

 

  

 

  

 

  

 

  

 

  

Exercise of warrants

 

143

 

143

Purchase of treasury shares

 

(564)

 

(564)

Share-based compensation expenses

 

433

 

433

Net settlement of RSUs

 

(97)

 

(97)

Balance at September 30, 2023

 

66

12,452

142

18,452

31,112

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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.

Except as described below, 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 2022 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.

The below accounting policies have been implemented upon Genmab receiving U.S. FDA approval on May 19, 2023 for EPKINLY. As of September 30, 2023, product sales, cost of product sales and inventory relate entirely to EPKINLY.

Revenue Recognition - Product Sales

Revenue is recognized when control is transferred to the customer and it is probable that Genmab will collect the consideration to which it is entitled for transferring the products. Control of the products is transferred at a single point in time which occurs upon delivery to the customer. The amount of sales to be recognized is based on the consideration Genmab expects to receive in exchange for its goods. When sales are recognized, an estimate for a variety of sales deductions is also recorded such as cash discounts, government rebates, chargebacks, wholesaler fees, other rebates and administrative fees, sales returns and allowances and other sales discounts. Sales deductions are estimated and recognized as a reduction of gross product sales to arrive at net product sales, by assessing the expected value of the sales deductions (variable consideration).

Accounts Receivable – Product Sales

Accounts receivable arising from product sales are initially measured at transaction price and subsequently measured at amortized cost, which generally corresponds to nominal value less expected credit losses. Genmab utilizes a simplified approach to measuring expected credit losses and uses a lifetime expected loss allowance for all receivables. To measure the expected credit losses, accounts receivables have been grouped based on credit risk characteristics and the days past due.

Accounts receivable arising from product sales consists of amounts due from customers, net of customer allowances for chargebacks, cash and other discounts and estimated credit losses. Genmab’s contracts with customers have initial payment terms that range from 30 to 180 days.

Inventories

Inventories are stated at the lower of cost or net realizable value with costs determined on a first-in, first-out basis. Genmab assesses the recoverability of capitalized inventories during each reporting period and will write down excess or obsolete inventories to its net realizable value in the period in which the impairment is identified within Cost of product sales in the statements of comprehensive income.

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Included in inventories are materials used in the production of clinical products, which are charged to research and development expenses when shipped to the clinical packaging site. Inventory manufactured prior to regulatory approval of a product (prelaunch inventory) is capitalized but immediately written down to zero. The cost of this write down is recognized in the statements of comprehensive income as research and development expenses. Once there is a high probability of regulatory approval being obtained for the product, the write-down is reversed, up to no more than the original cost. The reversal of the write-down is recognized as an offset to research and development expenses in the statements of comprehensive income.

Prior to receiving regulatory approval of EPKINLY in the U.S. and Japan, Genmab had written down inventory costs relating to the manufacture of EPKINLY to a net realizable value of zero. Capitalization of inventory costs associated with certain products prior to regulatory approval of such products is only appropriate when management considered it highly probable that pre-approval inventory costs would be recoverable through future sales of the drug product. The determination to capitalize was based on the particular facts and circumstances related to the expected regulatory approval of the product. The write down was recorded as research and development expenses in Genmab’s statements of comprehensive income. Upon receiving regulatory approval for EPKINLY in the U.S and Japan, Genmab reversed previously recorded inventory write downs which were not material. The reversal of previously recorded inventory write downs was based on a number of factors existing at that time, including the existence of inventory on hand and estimated demand, as well as expiration dating. The reversal of these inventory write downs was recorded as a reduction to research and development expenses in Genmab’s statements of comprehensive income.

Cost of Product Sales

Cost of product sales includes direct and indirect costs relating to the manufacture of inventory mainly from third-party providers of manufacturing as well as costs related to internal resources and distribution and logistics. Inventory amounts written down as a result of excess or obsolescence are charged to cost of product sales in the statements of comprehensive income.

Additionally, cost of product sales includes net profit-sharing amounts owed to collaboration partners for the sale of commercial products when Genmab is determined to be the principal in sales to end customers. As of September 30, 2023, the only net profit-sharing amounts owed recorded as cost of product sales relate to sales of EPKINLY pursuant to the Collaboration Agreement with AbbVie. Refer to Note 5.6 in the Annual Report for detailed information regarding Genmab’s Collaboration Agreement with AbbVie.

Management Judgements and Estimates under IFRS

In preparing interim reports, certain provisions under IFRS require management to make judgements (various accounting estimates and assumptions), which may significantly impact Genmab’s financial statements. For a description of significant judgements and estimates, refer to Note 1.3 in the Annual Report. Additionally, upon Genmab receiving U.S. FDA approval of EPKINLY during the quarter ended June 30, 2023, management has determined that estimation of sales deductions related to product sales is an area that requires significant estimation. Refer below for further information on the key accounting estimates related to sales deductions utilized in preparation of the consolidated financial statements.

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Sales Deductions

Sales deductions are estimated and provided for at the time the related sales are recorded. Genmab’s estimates related to sales deductions require significant use of estimates as not all conditions are known at the time of sale. The estimates are based on analyses of existing contractual obligations, historical experience, drug product analogs and payer channel mix.

Genmab considers the provisions established for sales deductions to be reasonable and appropriate based on currently available information; however, the actual amount of deductions may differ from the amounts estimated by management as more information becomes available. Estimates will be assessed each period and adjusted as required based on updated information and actual experience.

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, product sales 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

The table below summarizes Genmab’s revenue by type and collaboration partner, and royalties by product, under Genmab’s agreements.

    

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

2023

2022

2023

2022

(DKK million)

Revenue by type:

 

 

 

  

Royalties

 

3,868

 

3,480

9,803

 

8,207

Reimbursement revenue

 

306

 

307

789

 

594

Milestone revenue

 

342