Full Press Release Details
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
"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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 1/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Genmab Announces Financial Results for the First Nine Months of 2023
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
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.
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 |
Interim Report for the First Nine Months of 2023
| MANAGEMENT'S REVIEW | |
| CONSOLIDATED KEY FIGURES | 4 |
| OUTLOOK | 5 |
| KEY 2023 PRIORITIES | 6 |
| PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2023 | 6 |
| SIGNIFICANT RISKS AND UNCERTAINTIES | 17 |
| FINANCIAL REVIEW | 17 |
| FINANCIAL STATEMENTS | 25 |
| NOTES TO THE FINANCIAL STATEMENTS | 29 |
| ABOUT GENMAB | 39 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT | 40 |
| 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 |
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 | www.genmab.com | Page 4/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
| 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.
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.
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.
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 | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 5/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
| Bring Our Own Medicines to Patients | Epcoritamab 1 Launch in relapsed/refractory DLBCL Submit a Supplemental Biologics License Application (sBLA) 2 Broaden clinical development program |
| Tivdak 3 Progress successful uptake in second line+ recurring or metastatic cervical cancer patients Progress clinical development program | |
| Build World-class Differentiated Pipeline | DuoBody-CD40x4-1BB 4 Establish efficacy and safety data in solid tumor indication Progress towards late-stage clinical development |
| DuoBody-PD-L1x4-1BB 4 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 | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 6/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
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 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 chemotherapy 2 |
| 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 therapy 2 |
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 | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 7/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
Pipeline, Including Further Development for Approved Medicines
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
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 | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 8/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
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
EPKINLY/TEPKINLY (epcoritamab) - Approved in U.S., Europe and Japan
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 9/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
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
GEN1046 (BNT311) - Bispecific next-generation immunotherapy
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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 10/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
GEN1042 (BNT312) - Potential first-in-class bispecific agonistic antibody
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
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-na ve relapsed or refractory multiple myeloma patients.
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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 44 |
| Carl Jacobsens Vej 30 | www.genmab.com | Page 11/40 |
| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
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
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
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
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
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| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
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
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 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 myeloma 1 |
| Light-chain (AL) Amyloidosis 1 | ||
| 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) | NSCLC 1 |
| TECVAYLI (teclistamab/teclistamab-cqyv) | Janssen (Royalties to Genmab on net global sales) | Relapsed and refractory multiple myeloma 1 |
| TALVEY (talquetamab/talquetamab-tgvs) | Janssen (Royalties to Genmab on net global sales) | Relapsed and refractory multiple myeloma 1 |
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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| 2500 Valby, Denmark | CVR no. 2102 3884 |
Interim Report for the First Nine Months of 2023
Phase 2 Development, Including Further Development for Approved Medicines
2UltiMAb transgenic mouse technology licensed from Medarex, a wholly owned subsidiary of Bristol Myers Squibb.
DARZALEX (daratumumab) - Redefining the treatment of multiple myeloma
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.