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 2024


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, 333-253519, 333-262970 and 333-277273) 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 08, 2024


EXHIBIT INDEX

A

Exhibit

Description of Exhibit

99.1

Interim Report Dated August 08, 2024

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Extension Labels Linkbase Document

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document


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Exhibit 99.1

Graphic

Genmab Announces Financial Results for the First Half of 2024

August 8, 2024 Copenhagen, Denmark;

Interim Report for the First Six Months Ended June 30, 2024

Highlights

Completed acquisition of ProfoundBio Inc (ProfoundBio), granting Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate technology platforms  
The U.S. Food and Drug Administration (U.S. FDA) approved EPKINLY® (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of conditional marketing authorization of TEPKINLY® (epcoritamab) for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy
Tivdak® (tisotumab vedotin-tftv) received full U.S. FDA approval to treat recurrent or metastatic cervical cancer
Genmab submitted a Japan New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan for Tivdak (tisotumab vedotin) for the treatment of adult patients with advanced or recurrent cervical cancer that has progressed on or after chemotherapy
Genmab revenue increased 36% compared to the first six months of 2023, to DKK 9,545 million
Genmab 2024 financial guidance updated

“In the second quarter of 2024, we reached a number of significant milestones for the company. The acquisition of ProfoundBio, along with the regulatory approvals for EPKINLY and Tivdak, further solidify our commitment to the development of differentiated antibody therapies and will advance Genmab towards our ambitious 2030 vision of transforming the lives of patients with our innovative antibody medicines,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2024

Revenue was DKK 9,545 million for the first six months of 2024 compared to DKK 7,003 million for the first six months of 2023. The increase of DKK 2,542 million, or 36%, was primarily driven by higher DARZALEX® (daratumumab) and Kesimpta® (ofatumumab) royalties achieved under our collaborations with Janssen Biotech, Inc. (Janssen) and Novartis Pharma AG (Novartis), respectively, and increased EPKINLY net product sales.
Royalty revenue was DKK 7,673 million in the first six months of 2024 compared to DKK 5,886 million in the first six months of 2023, an increase of DKK 1,787 million, or 30%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX, including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), by Janssen were USD 5,570 million in the first six months of 2024 compared to USD 4,695 million in the first six months of 2023, an increase of USD 875 million or 19%.
Total costs and operating expenses were DKK 7,104 million in the first six months of 2024 compared to DKK 5,118 million in the first six months of 2023. The increase of DKK 1,986 million,

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 53

Carl Jacobsens Vej 30

www.genmab.com

Page 1/47

2500 Valby, Denmark

CVR no. 2102 3884

Graphic

Genmab Announces Financial Results for the First Half of 2024

or 39%, was driven by the expansion of our product pipeline, EPKINLY post-launch activities in the U.S. and Japan, the continued development of Genmab’s broader organizational capabilities and related increase in team members to support these activities, as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating profit was DKK 2,441 million in the first six months of 2024 compared to DKK 1,885 million in the first six months of 2023.
Net financial items resulted in income of DKK 1,402 million for the first six months of 2024 compared to DKK 75 million in the first six months of 2023. The increase of DKK 1,327 million was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab’s USD denominated cash and cash equivalents and marketable securities, with strengthening of the USD/DKK rate in the first six months of 2024 compared to the weakening of the USD/DKK rate in the first six months of 2023.

Significant Event Post-quarter End

August: Genmab announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech SE (BioNTech) has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. The companies’ long-standing collaboration in antibody science remains in place, and both parties will continue with the existing programs under development under their existing agreements, which were expanded in 2022.

Outlook

As announced in Company Announcement No. 52, Genmab is updating its 2024 financial guidance.

Revised

Revised

Guidance

Guidance

(DKK million)

ex. Acquisition and Integration related charges

    

incl. Acquisition and Integration related charges

    

Previous Guidance

Revenue

20,500 - 21,700

 

20,500 - 21,700

 

18,700 - 20,500

Royalties

16,600 - 17,400

16,600 - 17,400

15,600 - 16,700

Net product sales/Collaboration revenue*

2,000 - 2,200

2,000 - 2,200

1,700 - 2,200

Milestones/Reimbursement revenue

1,900 - 2,100

1,900 - 2,100

1,400 - 1,600

Gross profit**

19,600 - 20,800

19,600 - 20,800

18,000 - 19,500

Operating expenses**

(13,700) - (14,300)

 

(14,100) - (14,700)

 

(12,400) - (13,400)

Operating profit

5,300 - 7,100

 

4,900 - 6,700

 

4,600 - 7,100


*Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab’s share of net profits) in the U.S.

**Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range

Conference Call

Genmab will hold a conference call to discuss the results for the first half of 2024 today, August 8, 2024, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. 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

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 53

Carl Jacobsens Vej 30

www.genmab.com

Page 2/47

2500 Valby, Denmark

CVR no. 2102 3884

Graphic

Genmab Announces Financial Results for the First Half of 2024

personal PIN: https://register.vevent.com/register/BI61134ed097674233a89964e3bc06a69e. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.

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. 53

Carl Jacobsens Vej 30

www.genmab.com

Page 3/47

2500 Valby, Denmark

CVR no. 2102 3884

Graphic

Interim Report for the First Half of 2024

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 53

Carl Jacobsens Vej 30

www.genmab.com

Page 4/47

2500 Valby, Denmark

CVR no. 2102 3884

Graphic

Interim Report for the First Half of 2024

CONSOLIDATED KEY FIGURES

  

Three Months Ended

Six Months Ended

(DKK million)

June 30, 

June 30, 

Full Year

Income Statement

2024

2023

2024

2023

2023

Revenue

 

5,402

4,169

9,545

7,003

16,474

Cost of product sales

(190)

(21)

(375)

(21)

(226)

Research and development expenses

 

(2,502)

(1,853)

(4,801)

(3,594)

(7,630)

Selling, general and administrative expenses

 

(894)

(827)

(1,676)

(1,503)

(3,297)

Acquisition and integration related charges

(176)

(252)

Total costs and operating expenses

 

(3,762)

(2,701)

(7,104)

(5,118)

(11,153)

Operating profit

 

1,640

1,468

2,441

1,885

5,321

Net financial items

 

487

226

1,402

75

316

Net profit

 

1,408

1,335

2,733

1,545

4,352

Balance Sheet

 

Marketable securities

 

11,402

14,010

11,402

14,010

13,268

Cash and cash equivalents

4,331

10,874

4,331

10,874

14,867

Total non-current assets

 

16,682

2,229

16,682

2,229

2,150

Total assets

 

38,619

31,781

38,619

31,781

35,289

Shareholders' equity

 

30,969

28,558

30,969

28,558

31,610

Share capital

 

66

66

66

66

66

Cash Flow Statement

 

Cash flow from operating activities

 

1,513

436

3,026

3,671

7,380

Cash flow from investing activities

 

(8,772)

(1,835)

(10,213)

(1,848)

(1,282)

Cash flow from financing activities

 

(3,051)

7

(3,646)

(604)

(606)

Investment in intangible assets

(10)

(10)

(10)

Investment in tangible assets

 

(27)

(97)

(55)

(201)

(366)

Financial Ratios and Other Information

 

 

Basic net profit per share

 

21.85

20.46

42.13

 

23.66

66.64

Diluted net profit per share

 

21.70

20.28

41.85

 

23.45

66.02

Period-end share market price

 

1,745

2,580

1,745

 

2,580

2,155

Price / book value

 

3.72

5.96

3.72

 

5.96

4.50

Shareholders' equity per share

 

469.23

432.70

469.23

 

432.70

478.94

Equity ratio

 

80

%

90

%

80

%

90

%

90

%

Shares outstanding

66,136,909

66,038,425

66,136,909

66,038,425

66,074,535

Average number of employees (FTE*)

 

2,449

1,968

2,358

 

1,882

2,011

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

 

2,526

2,015

2,526

 

2,015

2,204

* Full-time equivalent or team members

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 53

Carl Jacobsens Vej 30

www.genmab.com

Page 5/47

2500 Valby, Denmark

CVR no. 2102 3884

Graphic

Interim Report for the First Half of 2024

OUTLOOK

Revised

Revised

Guidance

Guidance

(DKK million)

ex. Acquisition and Integration related charges

    

incl. Acquisition and Integration related charges

    

Previous Guidance

Revenue

20,500 - 21,700

 

20,500 - 21,700

 

18,700 - 20,500

Royalties

16,600 - 17,400

16,600 - 17,400

15,600 - 16,700

Net product sales/Collaboration revenue*

2,000 - 2,200

2,000 - 2,200

1,700 - 2,200

Milestones/Reimbursement revenue

1,900 - 2,100

1,900 - 2,100

1,400 - 1,600

Gross profit**

19,600 - 20,800

19,600 - 20,800

18,000 - 19,500

Operating expenses**

(13,700) - (14,300)

 

(14,100) - (14,700)

 

(12,400) - (13,400)

Operating profit

5,300 - 7,100

 

4,900 - 6,700

 

4,600 - 7,100

*Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab’s share of net profits) in the U.S.

**Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range

As announced in Company Announcement No. 52, Genmab is updating revenue, operating expenses and operating profit guidance for 2024. The revised guidance reflects an updated revenue outlook, incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S, as well as acquisition and integration related charges.

Revenue

Genmab currently expects 2024 revenue to be in the range of DKK 20.5 – 21.7 billion. Our projected increase in revenue for 2024 as compared to our previous guidance is driven by higher royalties and reimbursement revenue.

Royalty growth relates mainly to DARZALEX and Kesimpta net sales growth. DARZALEX royalties of DKK 13.3 – 13.8 billion are based on Genmab’s estimate of DARZALEX 2024 net sales of USD 11.4 – 11.8 billion. DARZALEX royalties are partly offset by Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with SC net sales as well as royalty reduction in countries and territories where there are no Genmab patents.

Operating Expenses

Genmab now anticipates its 2024 operating expenses (excluding acquisition and integration related charges) to be in the range of DKK 13.7 – 14.3 billion, an increase to the previous guidance of DKK 12.4 – 13.4 billion. The increase primarily relates to the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S as well as a revenue and expense classification change for programs that remain in Genmab’s collaboration with BioNTech. This classification change has resulted in Genmab increasing both cost reimbursement revenue and operating expense by approximately DKK 600 million, resulting in no impact on operating profit. Excluding the DKK 600 million related to the classification change and the acquisition and integration charges, the underlying operating expense range remains within the directional financial guidance provided at the time we announced the ProfoundBio acquisition.

Including acquisition and integration related charges, Genmab expects operating expenses for 2024 to be in the range of DKK 14.1 – 14.7 billion.

Genmab A/S

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Carl Jacobsens Vej 30

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Interim Report for the First Half of 2024

Operating Profit

Genmab now expects its 2024 operating profit excluding acquisition and integration related charges to be in the range of DKK 5.3 – 7.1 billion, compared to the previous guidance of DKK 4.6 – 7.1 billion, primarily driven by the items described above.

Including acquisition and integration related charges, Genmab expects operating profit for 2024 to be in the range of DKK 4.9 – 6.7 billion.

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, TALVEY and TEPKINLY net sales and royalties paid to Genmab; changing rates of inflation; and currency exchange rates (the 2024 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 2024 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 2024 Guidance and Key 2024 Priorities.

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.

KEY 2024 PRIORITIES

Bring Our Own Medicines to Patients

EPKINLY1

Initiate three Phase 3 trials
Expand label to include relapsed/refractory FL 

Tivdak2

Initiate Phase 3 study in head and neck cancer

Execute successful launches and growth in key markets

Build World-class Differentiated Pipeline   

Acasunlimab (GEN1046, DuoBody®-PD-L1x4-1BB)

Initiate Phase 3 study (second line non-small cell lung cancer (NSCLC))

GEN1042 (DuoBody-CD40x4-1BB)3

Phase 2 data and determine next steps

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. Co-development w/ Pfizer Inc. (Pfizer); 3. Co-development w/ BioNTech SE (BioNTech)

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PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2024

At the end of the first half of 2024, Genmab’s proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of thirteen antibody products 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 Pfizer, 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 six approved medicines powered by Genmab’s technology and innovations. Beyond the investigational medicines in clinical development, our pipeline includes multiple preclinical programs. An overview of the development status of our approved medicines and each of our investigational medicines is provided in the following section, including updates for the second quarter of 2024. For events that occurred during the first quarter of 2024, please refer to Genmab’s Q1 2024 report. 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) 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

EPKINLY

(epcoritamab-bysp, epcoritamab)

TEPKINLY

(epcoritamab)

CD3xCD20

Co-development

Genmab/AbbVie

Approved in multiple territories including in the U.S. and Europe for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy and in Japan for adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy2

Approved in the U.S. for adult patients with relapsed or refractory FL after two or more lines of systemic therapy2

Tivdak

(tisotumab vedotin-tftv)

Tissue factor (TF)

Co-development Genmab/Pfizer

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

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.

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Interim Report for the First Half of 2024

Pipeline, Including Further Development for Approved Medicines

Graphic

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

EPKINLY/TEPKINLY (epcoritamab) – First and only bispecific antibody approved in the U.S. to treat both relapsed or refractory FL and DLBCL after two or more lines of systemic therapy

SC bispecific antibody targeting CD3 and CD20, created using Genmab’s DuoBody technology platform
Epcoritamab (approved as EPKINLY and TEPKINLY) has received regulatory approvals in multiple territories including 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 therapy. EPKINLY has also been approved in the U.S. for the treatment of adults with relapsed or refractory FL after two or more lines of systemic therapy. See local prescribing information for specific indications and safety information
Regulatory submissions for epcoritamab for the treatment of relapsed or refractory FL after two or more lines of systemic therapy are currently under review in Europe and Japan
Multiple clinical trials are ongoing across different settings and histologies, including four Phase 3 trials, with more trials in planning
Co-developed and co-commercialized in collaboration with AbbVie

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 Inc. (Medarex) to generate the CD20 antibody forming part of epcoritamab. Epcoritamab is marketed as EPKINLY in the U.S., Japan, and other regions, and as TEPKINLY in Europe and other regions. 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 commercialization responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab records sales in the U.S. and Japan and receives tiered royalties between 22% and 26% on remaining global sales outside of

Genmab A/S

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these territories, subject to certain royalty reductions. The companies have a broad clinical development program for epcoritamab including four 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.

Second Quarter 2024 Updates

June: The U.S. FDA approved EPKINLY (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. The approval was supported by data from the FL cohort of the EPCORE™ NHL-1 trial (NCT03625037).
June: The EMA’s CHMP adopted a positive opinion recommending the granting of conditional marketing authorization of TEPKINLY (epcoritamab) for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.
June: Multiple data presentations were featured at the 2024 American Society of Clinical

Oncology (ASCO) Annual Meeting including two rapid oral presentations. These presentations highlighted data from the pivotal and cycle 1 dose optimization cohorts of the EPCORE NHL-1 clinical trial, which was subsequently selected for presentation at the Best of ASCO conference, and epcoritamab in combination with rituximab and lenalidomide in patients with previously untreated FL from the EPCORE NHL-2 (NCT04663347) clinical trial.

June: Multiple data presentations were featured at the 2024 European Hematology Association (EHA) Congress including three oral presentations. These presentations highlighted data from the pivotal and cycle 1 dose optimization cohorts of the EPCORE NHL-1 clinical trial, epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone as a potential first-line treatment regimen for patients with DLBCL from the EPCORE NHL-5 (NCT05283720) clinical trial, and primary results of epcoritamab in patients with Richter’s Transformation from the EPCORE CLL-1 (NCT04623541) clinical trial.
June: Data published in The Lancet Haematology, “Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study.”
May: Epcoritamab monotherapy was added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for “B-cell Lymphomas” (Version 2.2024) for third-line and subsequent therapy for patients with FL as a Category 2A, preferred regimen.

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
Full approval granted by the U.S. FDA for tisotumab vedotin-tftv, marketed as Tivdak, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy; Tivdak is the first ADC with demonstrated overall survival data to be granted full U.S. FDA approval in this patient population
Regulatory submissions for tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer are currently under review in both Japan and Europe
Clinical trials in other solid tumors are ongoing
Co-developed globally and co-promoted in the U.S. in collaboration with Pfizer

Tisotumab vedotin is an ADC composed of Genmab’s human monoclonal antibody directed to TF and Pfizer’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

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licensed from 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 Pfizer. Under a joint commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and will lead commercial operational activities in Japan. Pfizer 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 profit split. In other markets, Pfizer 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. Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety information, including the boxed warning.

Second Quarter 2024 Updates

June: Two data presentations were featured at the 2024 ASCO Annual Meeting including a rapid oral presentation of data from the Phase 2 innovaTV 207 (NCT03485209) trial, evaluating tisotumab vedotin in pretreated patients with relapsed/metastatic head and neck squamous cell carcinoma.
April: Genmab submitted a J-NDA to the MHLW in Japan for Tivdak for the treatment of adult patients with advanced or recurrent cervical cancer that has progressed on or after chemotherapy.
April: The U.S. FDA granted full approval for Tivdak (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This U.S. FDA action converted the September 2021 accelerated approval of Tivdak to a full approval.

Acasunlimab (GEN1046) – Bispecific next-generation immunotherapy

Bispecific antibody targeting PD-L1 and 4-1BB, created using Genmab’s DuoBody technology platform
Clinical trials in solid tumors ongoing
Genmab to assume sole responsibility for the continued development and potential commercialization of acasunlimab
In August 2024, BioNTech opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement

Acasunlimab (GEN1046, DuoBody-PD-L1x4-1BB) is a proprietary bispecific antibody, created using Genmab’s DuoBody technology platform. It was being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for acasunlimab on a 50:50 basis. In August 2024, Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech has opted not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. While the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it has taken this decision for reasons relating to its portfolio strategy. Acasunlimab 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. Acasunlimab is currently in Phase 2 clinical development. Based on encouraging data from the Phase 2 trial in NSCLC (NCT05117242), a Phase 3 trial is expected to start before the end of 2024.

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Second Quarter 2024 Update

June: Data from the Phase 2 trial of acasunlimab as a single agent or in combination with pembrolizumab for the treatment of relapsed/refractory metastatic NSCLC after treatment with standard of care therapy with an immune checkpoint inhibitor was presented as a poster at the 2024 ASCO Annual Meeting.

Rinatabart Sesutecan (Rina-S, GEN1184) – Potential best-in-class folate receptor alpha (FRα)-targeted TOPO1 ADC

FRα-targeted TOPO1 ADC being evaluated for potential treatment of FRα-expressing cancers
Phase 1/2 clinical trial (NCT05579366) in advanced solid tumors ongoing

Rina-S is a novel FRα-targeted TOPO1 ADC being evaluated for the potential treatment of ovarian cancer and other FRα-expressing cancers. Dose escalation data suggests that Rina-S has robust single agent activity in various cancers across a broad range of FRα expression levels. In January 2024, Rina-S was granted Fast Track Designation by the U.S. FDA for the treatment of FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. A Phase 1/2 trial of Rina-S in advanced solid tumors is ongoing. Based on encouraging data from this trial, a Phase 3 trial in second line plus platinum resistant ovarian cancer is expected to start before the end of 2024.

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

Bispecific antibody targeting CD40 and 4-1BB, created using Genmab’s DuoBody technology platform
Multiple Phase 1/2 clinical trials in solid tumors ongoing
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 activation of both dendritic cells and antigen-dependent T-cells. Three clinical trials of GEN1042 in solid tumors are ongoing.

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

Antibody targeting CD38, created using Genmab’s HexaBody technology platform
Phase 1/2 clinical trial (NCT04824794) in relapsed/refractory multiple myeloma and other hematological malignancies ongoing
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. GEN3014 is a second generation CD38-targeting lgG1 antibody with a hexamerization-enhancing modification. GEN3014 is designed to induce antitumor activity through highly potent complement-dependent cytotoxicity (CDC) and antitumor activity, which is enhanced compared to daratumumab as demonstrated in previously presented preclinical data and is effective at a wider range of target expression levels. 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 a cohort comparing GEN3014 to daratumumab in CD38 monoclonal antibody-naïve relapsed or refractory multiple myeloma patients.

Genmab A/S

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GEN1047 – Bispecific antibody with potential in solid tumors

Bispecific antibody targeting CD3 and B7H4, created using Genmab’s DuoBody technology platform
Phase 1/2 clinical trial (NCT05180474) in malignant solid tumors ongoing

GEN1047 (DuoBody-CD3xB7H4) is a bispecific antibody-based investigational medicine created using Genmab’s DuoBody technology platform. B7H4 is a tumor-associated antigen expressed on malignant cells in various solid cancers including breast, ovarian and lung cancer. In preclinical 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 and currently in the dose-expansion phase.

GEN3017 – DuoBody-based investigational therapy in the clinic

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

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 preclinical studies, GEN3017 induced potent T-cell mediated cytotoxicity of CD30-expressing tumor cells, 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.

GEN1059 (BNT314) – Bispecific antibody with potential in solid tumors

Bispecific antibody targeting epithelial cell adhesion molecule (EpCAM) and 4-1BB, created using Genmab’s DuoBody technology platform
Phase 1/2 clinical trial (NCT06150183) in solid tumors ongoing
Co-developed in collaboration with BioNTech

GEN1059 (DuoBody-EpCAMx4-1BB, BNT314), jointly owned by Genmab and BioNTech and created using Genmab’s DuoBody technology platform, is a proprietary bispecific antibody aimed at boosting antitumor immune responses through EpCAM-dependent 4-1BB agonistic activity. GEN1059 is being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs and future potential profits for GEN1059 on a 50:50 basis. A Phase 1/2 clinical trial of GEN1059 in solid tumors is ongoing.

GEN1055 (BNT315) – HexaBody-based antibody with potential in solid tumors

Antibody targeting OX40, created using Genmab’s HexaBody technology platform
Phase 1/2 clinical trial (NCT06391775) in malignant solid tumors ongoing
Co-developed in collaboration with BioNTech

GEN1055 (HexaBody-OX40, BNT315), jointly owned by Genmab and BioNTech and created using Genmab’s HexaBody technology platform, is an immune-modulating OX40 agonist antibody that promotes immunity by inducing T-cell responses through FcγR-independent OX40 clustering on T cells. GEN1055 is being co-developed by Genmab and BioNTech under an agreement in which the companies

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share all costs and future potential profits for GEN1055 on a 50:50 basis. A Phase 1/2 clinical trial of GEN1055 in solid tumors is ongoing.

Second Quarter 2024 Update

June: The first patient was treated in the first-in-human Phase 1/2 trial of GEN1055 in malignant solid tumors.

GEN1160 – ADC with potential in both solid tumors and hematological malignancies

CD70-targeted ADC being evaluated in advanced solid and liquid tumors
Phase 1/2 clinical trial (NCT05721222) in advanced solid and liquid tumors ongoing

GEN1160 is a CD70-targeted ADC. CD70 is a protein expressed on both solid tumors and hematological malignancies. A Phase 1/2 clinical study of GEN1160 in advanced renal cell carcinoma, nasopharyngeal carcinoma and NHL is ongoing.

GEN1107 – ADC with potential in solid tumors

PTK7-targeted ADC being evaluated in advanced solid tumors
Phase 1/2 clinical trial (NCT06171789) in advanced solid tumors ongoing

GEN1107 is a PTK7-targeted ADC. PTK7 is a clinically validated ADC target with broad solid tumor expression, particularly in tumor-initiating cells. A Phase 1/2 clinical study of GEN1107 in advanced solid tumors is ongoing.

GEN1056 (BNT322)

Phase 1 clinical trial (NCT05586321) in solid tumors ongoing
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. A first-in-human Phase 1 clinical study of GEN1056 in patients with advanced solid tumors is ongoing.

GEN1053 (BNT313) – HexaBody-based investigational medicine

Antibody targeting CD27, created using Genmab’s HexaBody technology platform
Co-developed in collaboration with BioNTech

GEN1053 (HexaBody-CD27, BNT313) is a CD27 antibody that utilizes Genmab’s HexaBody technology, specifically engineered to induce CD27 clustering on T cells and thus to enhance T cell activation. It was being co-developed by Genmab and BioNTech under an agreement in which the companies share all costs for GEN1053 on a 50:50 basis. Following a strategic evaluation of GEN1053 within the context of Genmab’s and BioNTech’s portfolios, a decision was made to discontinue the Phase 1/2 clinical trial (NCT05435339) of GEN1053 in solid tumors. Preclinical activities remain ongoing.

Preclinical Programs

Broad preclinical 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 the coming years
Genmab has entered multiple strategic collaborations to support the expansion of our innovative pipeline

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Our preclinical pipeline includes immune effector function enhanced antibodies developed with our HexaBody technology platform, bispecific antibodies created with our DuoBody technology platform and ADCs created with our ADC technology platforms. We are also collaborating with our partners to generate additional new antibody-based product concepts. A number of the preclinical programs are conducted in cooperation with our collaboration partners.

Programs Incorporating Genmab’s Innovation and Technology1

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 information in this section includes those therapies that have been approved by regulatory agencies in certain territories. Under the agreements for these medicines Genmab is entitled to certain potential milestones and royalties.

Approved Medicines1

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 myeloma2

Light-chain (AL) Amyloidosis2

Kesimpta

(ofatumumab)

Novartis (Royalties to Genmab on net global sales)

Relapsing multiple sclerosis (RMS)2

TEPEZZA

(teprotumumab-trbw)

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

Thyroid eye disease (TED)2

RYBREVANT

(amivantamab/amivantamab-vmjw)

Janssen (Royalties to Genmab on net global sales)

NSCLC2

TECVAYLI

(teclistamab/teclistamab-cqyv)

Janssen (Royalties to Genmab on net global sales)

Relapsed and refractory multiple myeloma2

TALVEY

(talquetamab/talquetamab-tgvs)

Janssen (Royalties to Genmab on net global sales)

Relapsed and refractory multiple myeloma2

1Approved and investigational medicines created by Genmab or created by collaboration partners leveraging Genmab’s DuoBody technology platform, under development, and where relevant, commercialized by a third party.
2See local prescribing information for precise indication and safety information.

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Pipeline, Including Further Development for Approved Medicines, ≥ Phase 2 Development

Graphic

*UltiMAb 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) formulation 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 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 5,570 million in the first six months of 2024

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 receives royalties between 12% and 20% with Janssen reducing such royalty payments for Genmab’s share of Janssen’s royalty payments made to Halozyme; payments are further reduced in countries and territories where there are no relevant patents. Daratumumab (marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the U.S. 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.

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Prescribing Information for DARZALEX and DARZALEX FASPRO for the labeled indication and safety information.

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 multiple territories including the U.S., Europe 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 receives a 10% royalty on net sales of Kesimpta, and Genmab pays a royalty to Medarex based on Kesimpta sales. 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

Developed and commercialized 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 Therapeutics plc (Horizon) under a sublicense from Roche. In October 2023, Amgen completed its acquisition of Horizon, including the rights to all commercialization and development of teprotumumab. Under the terms of Genmab’s agreement with Roche, Genmab receives a mid-single digit royalty on net sales (as defined) 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, and as amended in December 2013, 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 by Genmab. In collaboration with Janssen, the antibody pair used to

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create amivantamab was co-discovered. Amivantamab, marketed as RYBREVANT, is approved in certain territories for the treatment of certain adult patients with NSCLC. Janssen is responsible for the development and commercialization of amivantamab. Under the agreement with Janssen, Genmab is eligible to receive milestones and receives royalties between 8% and 10% on net sales of RYBREVANT subject to a reduction of such royalty payments in countries and territories where there are no relevant patents, among other reductions. Genmab pays a royalty to Medarex based on RYBREVANT net sales. 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, and as amended in December 2013, 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. Teclistamab, marketed as TECVAYLI, is approved in certain territories for the treatment of certain adult patients with relapsed or refractory multiple myeloma. Janssen is responsible for the development and commercialization of TECVAYLI. Under our agreement with Janssen, Genmab is eligible to receive milestones and receives a mid-single digit royalty on net sales of TECVAYLI subject to a reduction of such royalty payments in countries and territories where there are no relevant patents, among other reductions. 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 is eligible to receive milestones and royalties on net sales of TALVEY

In July 2012, and as amended in December 2013, 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 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. Talquetamab, marketed as TALVEY, is approved in certain territories for the treatment of certain adult patients with relapsed or refractory multiple myeloma. Janssen is responsible for the development and commercialization of TALVEY. Under our agreement with Janssen, Genmab is eligible to receive milestones and receives a mid-single digit royalty on net sales of TALVEY subject to a reduction of such royalty payments in countries and territories where there are no relevant patents, among other reductions. Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for TALVEY for the labeled indication and safety information.

Genmab A/S

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Interim Report for the First Half of 2024

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.

With the acquisition of ProfoundBio, Genmab has an increased operating presence in China. This increased presence subjects Genmab to risks specific to conducting business in China such as being subject to changes in the political, economic and tax policies of the Chinese government or in relationships between China and Demark, the United States or other governments. In addition, the Chinese government has discretion and oversight over the conduct of the business operations of Genmab’s Chinese subsidiaries. Genmab mitigates these risks through the monitoring of the activities of our Chinese subsidiaries as well as geopolitical activities as they pertain to our global operations.

For further information about risks and uncertainties that Genmab faces, refer to the 2023 Annual Report filed with the Nasdaq Copenhagen and the Form 20-F filed with the U.S. SEC, both of which were filed in February 2024. 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, other than those additional risks in regard to our Chinese subsidiaries stated above. See Genmab’s Form 20-F for a detailed summary of risks related to our collaborations.

Genmab A/S

Tel: +45 7020 2728

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Carl Jacobsens Vej 30

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Interim Report for the First Half of 2024

FINANCIAL REVIEW

The interim report is prepared on a consolidated basis for Genmab A/S (parent company) and its subsidiaries. The Genmab financial statements are published in Danish Kroner (DKK). The Genmab consolidated Group is referenced herein as “Genmab” or the “Company”. On May 21, 2024 (Acquisition Date), Genmab completed the previously announced acquisition of all of the outstanding shares of ProfoundBio, resulting in ProfoundBio becoming a wholly-owned subsidiary of Genmab. From the Acquisition Date through the second quarter of 2024, ProfoundBio’s financial results have been incorporated into Genmab’s Consolidated Financial Statements.

Revenue

Genmab’s revenue was DKK 9,545 million for the first six months of 2024 compared to DKK 7,003 million for the first six months of 2023. The increase of DKK 2,542 million, or 36%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis, respectively, and increased EPKINLY net product sales.

    

Three Months Ended

Six Months Ended

June 30, 

June 30, 

(DKK million)

2024

2023

2024

2023

Royalties

 

4,569

 

3,478

7,673

 

5,886

Reimbursement revenue

 

289

 

228

569

 

483

Milestone revenue

 

 

351

343

 

455

Collaboration revenue

113

73

206

140

Net product sales

431

39

754

39

Total revenue

 

5,402

 

4,169

9,545

 

7,003

Royalties

Royalty revenue amounted to DKK 7,673 million in the first six months of 2024 compared to DKK 5,886 million in the first six months of 2023. The increase of DKK 1,787 million, or 30%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our daratumumab collaboration with Janssen and ofatumumab collaboration with Novartis. The table below summarizes Genmab’s royalty revenue by product.

Three Months Ended

Six Months Ended

June 30, 

June 30, 

(DKK million)

2024

2023

2024

2023

DARZALEX

 

3,731

 

2,923

6,113

 

4,855

Kesimpta

553

334

990

600

TEPEZZA

 

161

 

170

342

 

336

Other

124

51

228

95

Total royalties

 

4,569

 

3,478

7,673

 

5,886

Net sales of DARZALEX by Janssen were USD 5,570 million in the first six months of 2024 compared to USD 4,695 million in the first six months of 2023. The increase of USD 875 million, or 19%, was driven by market share gains in all regions. Royalty revenue on net sales of DARZALEX was DKK 6,113 million in the first six months of 2024 compared to DKK 4,855 million in the first six months of 2023, an increase of DKK 1,258 million. The percentage increase in royalties of 26% is higher than the percentage increase in the underlying net sales primarily due to a higher effective royalty rate and a higher average exchange rate between the USD and DKK.

Genmab A/S

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Interim Report for the First Half of 2024

Net sales of Kesimpta by Novartis were USD 1,436 million in the first six months of 2024 compared to USD 873 million in the first six months of 2023. The increase of USD 563 million, or 64%, was primarily driven by increased demand and strong access. Royalty revenue on net sales of Kesimpta was DKK 990 million in the first six months of 2024 compared to DKK 600 million in the first six months of 2023, an increase of DKK 390 million, or 65%.

Net sales of TEPEZZA by Amgen were USD 903 million in the first six months of 2024 compared to USD 843 million in the first six months of 2023. Royalty revenue on net sales of TEPEZZA was DKK 342 million in the first six months of 2024 compared to DKK 336 million in the first six months of 2023, an increase of DKK 6 million, or 2%.

Other royalties consist of royalties from net sales of RYBREVANT, TECVAYLI, TALVEY and TEPKINLY. These royalties were not material for the first six months of 2024 or 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, Genmab’s share of Janssen’s royalty payments to Halozyme in connection with SC product net sales and the level of royalty deductions on net sales in countries and territories where there is no patent protection.

Reimbursement Revenue

Reimbursement revenue amounted to DKK 569 million in the first six months of 2024 compared to DKK 483 million in the first six months of 2023. The increase of DKK 86 million, or 18%, was primarily driven by higher activities under our collaboration agreements with BioNTech for acasunlimab and DuoBody-CD40x4-1BB.

Milestone Revenue

Milestone revenue was DKK 343 million in the first six months of 2024 compared to DKK 455 million in the first six months of 2023, a decrease of DKK 112 million, or 25%, primarily driven by milestones of DKK 104 million achieved under our Janssen DuoBody collaboration in 2023.

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 206 million in the first six months of 2024 compared to DKK 140 million in the first six months of 2023, an increase of DKK 66 million, or 47%, primarily driven by an increase in net sales of Tivdak.

Net Product Sales

Net product sales were DKK 754 million in the first six months of 2024 compared to DKK 39 million in the first six months of 2023. EPKINLY was approved in the U.S. in May 2023 and in Japan in September 2023.

Net sales of TEPKINLY in territories where Genmab receives royalty revenue were USD 12 million in the first six months of 2024, with no net sales in the first six months of 2023 due to regulatory approvals in such territories not occurring until late 2023.

Genmab A/S

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Carl Jacobsens Vej 30

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Interim Report for the First Half of 2024

Refer to Financial Statement Note 3 in this interim report for further details about revenue.

Key Developments to Revenue – Second Quarter of 2024

Genmab’s revenue was DKK 5,402 million for the second quarter of 2024 compared to DKK 4,169 million for the second quarter of 2023. The increase of DKK 1,233 million, or 30%, was primarily driven by higher

DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis,

respectively, and increased EPKINLY net product sales, partly offset by a decrease in milestone revenue achieved during the second quarter of 2024 as compared to the second quarter of 2023.

Cost of Product Sales

Genmab recognized cost of product sales of DKK 375 million in the first six months of 2024 compared to DKK 21 million in the first six months of 2023. Cost of product sales related to EPKINLY sales is primarily comprised of profit-sharing amounts payable to AbbVie of DKK 352 million as well as product costs. EPKINLY was approved in the U.S. in May 2023 and in Japan in September 2023.

Key Developments to Cost of Product Sales – Second Quarter of 2024

Cost of product sales were DKK 190 million for the second quarter of 2024 compared to DKK 21 million for the second quarter of 2023. EPKINLY was approved in the U.S. in May 2023 and in Japan in September 2023.

Research and Development Expenses

Research and development expenses amounted to DKK 4,801 million in the first six months of 2024 compared to DKK 3,594 million in the first six months of 2023. The increase of DKK 1,207 million, or 34%, was driven by the increased and accelerated advancement of epcoritamab under our collaboration with AbbVie, increased activities of DuoBody-CD40x4-1BB and acasunlimab under our collaboration with BioNTech and DuoBody-CD3xCD30, 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 74% of total research and development expenses & selling, general and administrative expenses in the first six months of 2024 compared to 71% in the first six months of 2023.

Key Developments to Research and Development Expenses – Second Quarter of 2024

Research and development expenses were DKK 2,502 million for the second quarter of 2024 compared to DKK 1,853 million for the second quarter of 2023. The increase of DKK 649 million, or 35%, was primarily driven by the increased and accelerated advancement of epcoritamab under our collaboration with AbbVie, increase in team members to support the continued expansion of our product portfolio, and the addition of ProfoundBio related research and development expenses.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were DKK 1,676 million in the first six months of 2024 compared to DKK 1,503 million in the first six months of 2023. The increase of DKK 173 million, or 12%, was driven by the continued expansion of Genmab’s commercialization capabilities through the increase in team members to support EPKINLY in the U.S. and Japan post-launch, and the investment in Genmab’s broader organizational capabilities.

Selling, general and administrative expenses accounted for 26% of total research and development expenses & selling, general and administrative expenses in the first six months of 2024 compared to 29% for the first six months of 2023.

Genmab A/S

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Interim Report for the First Half of 2024

Key Developments to Selling, General and Administrative Expenses – Second Quarter of 2024

Selling, general and administrative expenses were DKK 894 million for the second quarter of 2024 compared to DKK 827 million for the second quarter of 2023. The increase of DKK 67 million, or 8%, was primarily driven by the continued expansion of Genmab’s commercialization capabilities through the increase in team members to support Epkinly in the U.S. and Japan post-launch, and the investment in Genmab’s broader organizational capabilities.

Acquisition and Integration Related Charges

Acquisition and integration related charges for the acquisition of ProfoundBio were DKK 252 million in the first six months of 2024.

Key Developments to Acquisition and Integration Related Charges – Second Quarter of 2024

Acquisition and integration related charges for the acquisition of ProfoundBio were DKK 176 million for the second quarter of 2024. There were no acquisition and integration related charges for the second quarter of 2023.

Operating Profit

Operating profit was DKK 2,441 million in the first six months of 2024 compared to DKK 1,885 million in the first six months of 2023.

Net Financial Items

Net financial items include the following:

    

Three Months Ended

Six Months Ended

June 30, 

June 30, 

(DKK million)

2024

2023

2024

2023

Interest and other financial income

 

292

227

609

428

Gain on marketable securities

85

86

218

248

Gain on other investments

114

33

121

62

Foreign exchange rate gain

 

395

1,045

Total financial income

 

886

346

1,993

 

738

Interest and other financial expenses

 

(19)

(25)

(48)

(40)

Loss on marketable securities

(39)

(82)

(129)

(159)

Loss on other investments

(85)

(3)

(98)

(25)

Foreign exchange rate loss

(256)

(10)

(316)

(439)

Total financial expenses

 

(399)

 

(120)

(591)

 

(663)

Net financial items

 

487

 

226

1,402

 

75

Interest Income

Interest income was DKK 609 million in the first six months of 2024 compared to DKK 428 million in the first six months of 2023. The increase of DKK 181 million was primarily driven by higher cash and cash equivalents and marketable securities, as well as higher interest rates on USD denominated marketable securities in 2024 versus 2023.

Foreign Exchange Rate Gains and Losses

Foreign exchange rate gain, net was DKK 729 million, comprised of DKK 1,045 million foreign exchange rate gains, offset by DKK 316 million foreign exchange rate losses in the first six months of 2024 compared to foreign exchange rate loss of DKK 439 million in the first six months of 2023. The USD

Genmab A/S

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Interim Report for the First Half of 2024

strengthened against the DKK in the first six months of 2024, positively impacting our USD denominated securities and cash holdings. The USD weakened against the DKK in the first six months of 2023, negatively impacting our USD denominated securities and cash holdings.

    

June 30, 2024

December 31, 2023

June 30, 2023

December 31, 2022

USD/DKK Foreign Exchange Rates

6.9664

6.7447

6.8539

6.9722

% Increase/(decrease) from prior year-end

3.3%

(1.7)%

Refer to Financial Statement Note 6 in this interim report for further details about the net financial items.

Key Developments to Net Financial Items – Second Quarter of 2024

Foreign Exchange Rate Gains and Losses

Foreign exchange rate gain, net was DKK 139 million, comprised of DKK 395 million foreign exchange rate gains, offset by DKK 256 million foreign exchange rate losses in the second quarter of 2024 compared to the foreign exchange rate loss of DKK 10 million in the second quarter of 2023. The USD strengthened against the DKK in the second quarter of 2024, positively impacting our USD denominated securities and cash holdings. The USD weakened against the DKK in the second quarter of 2023, negatively impacting our USD denominated securities and cash holdings.

Interest Income

Interest Income was DKK 292 million for the second quarter of 2024 compared to DKK 227 million for the second quarter of 2023. The increase of DKK 65 million was primarily driven by higher cash and cash equivalents and marketable securities, as well as higher interest rates on USD denominated marketable securities in 2024 versus 2023.

Corporate Tax

Corporate tax expense for the first six months of 2024 was DKK 1,110 million compared to DKK 415 million for the first six months of 2023. The increase in corporate tax expense is primarily the result of Genmab’s higher net profit before tax and an increase in the estimated annual effective tax rate in the first six months of 2024 to 28.9% from 21.2% in the first six months of 2023. The increase in Genmab’s effective tax rate was mainly driven by the increase in the deferred provision attributable to losses in relation to EPKINLY commercial expenses in the U.S. and ProfoundBio operational losses in the U.S. for which tax benefit cannot be recognized.

With the acquisition of ProfoundBio, Genmab is currently evaluating the integration of ProfoundBio operations from a tax perspective. As a result, Genmab’s effective tax rate may experience some volatility as integration activities progress, but is anticipated to normalize within the next 12-18 months.

Key Developments to Corporate Tax – Second Quarter of 2024

Corporate tax expense for the second quarter of 2024 was DKK 719 million compared to DKK 359 million for the second quarter of 2023. The increase in corporate tax expense is primarily the result of Genmab’s higher net profit before tax and an increase in the estimated annual effective tax rate, driven by an increase in the deferred provision attributable to nondeductible losses in relation to EPKINLY commercial expenses in the U.S. and ProfoundBio operational losses in the U.S.

Genmab A/S

Tel: +45 7020 2728

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Carl Jacobsens Vej 30

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Interim Report for the First Half of 2024

Net Profit

Net profit for the first six months of 2024 was DKK 2,733 million compared to DKK 1,545 million in the first six months of 2023. The increase was driven by the items described above.

Liquidity and Capital Resources

(DKK million)

    

June 30, 2024

    

December 31, 2023

Marketable securities

 

11,402

 

13,268

Cash and cash equivalents

 

4,331

 

14,867

Shareholders' equity

 

30,969

 

31,610

Six Months Ended

June 30, 

Cash Flow (DKK million)

 

2024

    

2023

Cash provided by operating activities

3,026

 

3,671

Cash (used in) investing activities

(10,213)

 

(1,848)

Cash provided by (used in) financing activities

(3,646)

(604)

Increase (decrease) in cash and cash equivalents

(10,833)

 

1,219

Exchange Rate adjustments

297

(238)

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. The DKK 645 million decrease in net cash provided by operating activities is driven by the unfavorable impact on cash flow of DKK 1,168 million of net foreign exchange rate gains in the first six months of 2024 compared to the first six months of 2023 as well as significant AbbVie milestones achieved with related cash received during the first six months of 2023, with no material milestones in the first six months of 2024. This impact was offset by an increase in net profit before tax of DKK 1,883 million in the first six months of 2024 compared to the first six months of 2023.

Net cash used in investing activities primarily reflects cash used in making acquisitions, differences between the proceeds received from the sale and maturity of our investments and amounts invested, and the cash paid for investments in tangible assets. The increase in net cash used in investing activities is primarily driven by the acquisition of ProfoundBio, partly offset by the sales and maturities of marketable securities exceeding purchases in the first six months of 2024, compared to purchases exceeding sales and maturities in the first six 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 increase in net cash (used in) financing activities between the periods is primarily driven by higher purchases of treasury shares of DKK 3,585 million in the first six months of 2024 related to the share buy-back programs initiated in March 2024 and completed in June 2024 compared to DKK 564 million in the first six months of 2023.

Genmab’s USD denominated marketable securities represented 78% of Genmab’s total marketable securities as of June 30, 2024, compared to 81% as of December 31, 2023. The decrease was primarily attributable to the liquidation of USD denominated marketable securities to fund the acquisition of ProfoundBio and the purchase of treasury shares.

Genmab A/S

Tel: +45 7020 2728

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Carl Jacobsens Vej 30

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Interim Report for the First Half of 2024

Cash and cash equivalents included short-term marketable securities of DKK 13 million as of June 30, 2024, compared to DKK 1,353 million as of December 31, 2023. 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 5 in this interim report for further details about our marketable securities.

Balance Sheet

As of June 30, 2024, total assets were DKK 38,619 million compared to DKK 35,289 million on December 31, 2023. As of June 30, 2024, assets were mainly comprised of intangible assets of DKK 12,011 million, primarily made up of intangible assets acquired in the ProfoundBio acquisition, marketable securities of DKK 11,402 million, current receivables of DKK 6,168 million, cash and cash equivalents of DKK 4,331 million and DKK 2,518 million of goodwill related to the acquisition of ProfoundBio. The current receivables consist primarily of amounts related to royalties from our collaboration agreements.

As of June 30, 2024, total liabilities were DKK 7,650 million compared to DKK 3,679 million on December 31, 2023. The increase in total liabilities of DKK 3,971 million was primarily driven by the deferred tax liability assumed in the acquisition of ProfoundBio, accruals related to the expansion of our product pipeline, an increase in corporate taxes payable due to Genmab’s net profit before tax and increase in Genmab’s effective tax rate, and an increase in lease liabilities for the commencement of a lease in the U.S. with respect to office and laboratory space.

Shareholders’ equity as of June 30, 2024, was DKK 30,969 million compared to DKK 31,610 million on December 31, 2023. The decrease of DKK 641 million, or 2%, was primarily driven by Genmab’s purchase of treasury shares, partly offset by the net profit for the period and share-based compensation expenses. The decrease in Genmab’s equity ratio, which was 80% as of June 30, 2024, compared to 90% as of December 31, 2023, was primarily attributable to assets acquired in the acquisition of Profoundbio, net of cash paid, in addition to a decrease in shareholder’s equity due to the share buy-back completed in June 2024. 

Team Members

As of June 30, 2024, the total number of team members was 2,526 compared to 2,015 as of June 30, 2023. 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 EPKINLY in the U.S. and Japan post launch activities, and broader organizational capabilities and the acquisition of ProfoundBio.

Six Months Ended

June 30, 

Team Members

    

2024

    

2023

Research and development team members

 

1,774

1,396

Selling, general and administrative team members

 

752

619

Total team members

 

2,526

 

2,015

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

Genmab A/S

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Interim Report for the First Half of 2024

the binding arbitration of the two matters in favor of Janssen. Genmab did not seek a review of the award, and the award is 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 filed a request for review of the award, which was denied on January 23, 2024. As a result, the dismissal of Genmab’s claims in the second arbitration is now final.

Chugai Patent Infringement Complaint

In June 2024, Chugai Pharmaceutical Co., Ltd. filed a lawsuit in the Tokyo District Court, Japan against AbbVie’s and Genmab’s subsidiaries in Japan asserting that their activities with EPKINLY (epcoritamab) in Japan infringe two Japanese patents held by Chugai, JP6278598 and JP6773929. Chugai is claiming damages and injunctive relief.

Genmab and AbbVie believe that the two Japanese patents are invalid and not infringed and intend to vigorously defend against the lawsuit, and thus no provision has been recorded related to this matter.

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Interim Report for the First Half of 2024

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

    

Three Months Ended

Six Months Ended

June 30, 

June 30, 

Note

 

2024

2023

2024

2023

(DKK million)

 

Revenue

3

5,402

4,169

9,545

7,003

Cost of product sales

(190)

(21)

(375)

(21)

Research and development expenses

 

(2,502)

(1,853)

(4,801)

(3,594)

Selling, general and administrative expenses

 

(894)

(827)

(1,676)

(1,503)

Acquisition and integration related charges

2

(176)

(252)

Total costs and operating expenses

 

(3,762)

(2,701)

(7,104)

(5,118)

Operating profit

 

1,640

 

1,468

2,441

1,885

Financial income

6

 

886

346

1,993

738

Financial expenses

6

(399)

(120)

(591)

(663)

Net profit before tax

 

2,127

1,694

3,843

1,960

Corporate tax

 

(719)

(359)

(1,110)

(415)

Net profit

 

1,408

1,335

2,733

1,545

Other comprehensive income:

  

 

  

 

  

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

  

 

  

 

  

Exchange differences on translation of foreign operations

126

(5)

174

14

Total comprehensive income

1,534

1,330

2,907

1,559

Basic net profit per share

 

21.85

20.46

42.13

23.66

Diluted net profit per share

 

21.70

20.28

41.85

23.45

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Interim Report for the First Half of 2024

CONDENSED CONSOLIDATED BALANCE SHEETS

    

    

June 30, 

    

December 31, 

Note

2024

2023

(DKK million)

ASSETS

 

  

 

  

 

  

Intangible assets

 

4

 

12,011

 

101

Property and equipment

 

  

 

952

 

955

Right-of-use assets

 

9

 

928

 

686

Receivables

 

  

 

77

 

62

Deferred tax assets

 

  

 

 

212

Other investments

5

196

134

Goodwill

4

2,518

Total non-current assets

 

  

 

16,682

 

2,150

Inventories

36

57

Receivables

 

  

 

6,168

 

4,947

Marketable securities

 

5

 

11,402

 

13,268

Cash and cash equivalents

 

  

 

4,331

 

14,867

Total current assets

 

  

 

21,937

 

33,139

Total assets

 

  

 

38,619

 

35,289

SHAREHOLDERS’ EQUITY AND LIABILITIES

 

  

 

  

 

  

Share capital

 

  

 

66

 

66

Share premium

 

  

 

12,536

 

12,461

Other reserves

 

  

 

234

 

60

Retained earnings

 

  

 

18,133

 

19,023

Total shareholders' equity

 

  

 

30,969

 

31,610

Lease liabilities

 

9

 

925

 

680

Deferred revenue

3

480

480

Deferred tax liabilities

1,853

Other payables

 

  

 

28

 

35

Total non-current liabilities

 

  

 

3,286

 

1,195

Corporate tax payable

837

54

Lease liabilities

 

9

 

94

 

90

Deferred revenue

3

33

33

Other payables

 

  

 

3,400

 

2,307

Total current liabilities

 

  

 

4,364

 

2,484

Total liabilities

 

  

 

7,650

 

3,679

Total shareholders' equity and liabilities

 

  

 

38,619

 

35,289

Share-based payments

 

7

 

  

 

  

Related parties

 

8

 

  

 

  

Contingency

10

Subsequent events to the balance sheet date

 

11

 

  

 

  

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Interim Report for the First Half of 2024

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended

June 30, 

    

Note

    

2024

    

2023

(DKK million)

Net profit before tax

3,843

1,960

Financial income

(1,993)

(738)

Financial expenses

591

663

Adjustments for non-cash transactions

Share-based compensation expense

7

349

271

Depreciation