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Genmab Announces Financial Results for the First Nine Months of 2022

Key Takeaway: Genmab Announces Financial Results for the First Nine Months of 2022 November 9, 2022 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2022 "During the first nine months of the year we continued to build on Genmab's consistent track record of s

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Genmab Announces Financial Results for the First Nine Months of 2022
November 9, 2022 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2022
"During the first nine months of the year we continued to build on Genmab's consistent track record of success. We have strengthened our pipeline, our team and our financial foundation is even more robust. We are pleased with the recent U.S. and European regulatory submissions for epcoritamab. These submissions are an important step in potentially bringing epcoritamab to people living with certain hematologic malignancies who are in need of a new treatment option," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2022
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 1/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Genmab Announces Financial Results for the First Nine Months of 2022
Epcoritamab Regulatory Update
There were two regulatory submissions for epcoritamab in the second half of 2022. Genmab submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (U.S. FDA) for subcutaneous (SC) epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Additionally, AbbVie submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for SC epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, which has been validated by the EMA. Both submissions were supported by results from the LBCL cohort of the pivotal EPCORE NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL.
As announced in Company Announcement No. 54, Genmab is improving its 2022 financial guidance published on August 8, 2022, driven primarily by the positive foreign exchange rate impact on our royalty revenue, and the continued strong performance of DARZALEX net sales.
Revised Previous
(DKK million) Guidance Guidance
Revenue 13,500 - 14,500 12,000 - 13,000
Operating expenses (8,000) - (8,400) (7,600) - (8,200)
Operating profit 5,100 - 6,500 3,800 - 5,400
Genmab will hold a conference call in English to discuss the results for the first nine months of 2022 today, Wednesday, November 9, 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/BI2f752c494cf441f8b2fd8379c5219dc7. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
Marisol Peron, Senior Vice President, Communications and 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. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 2/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
MANAGEMENT'S REVIEW
CONSOLIDATED KEY FIGURES 4
OUTLOOK 5
KEY 2022 PRIORITIES 6
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2022 7
SIGNIFICANT RISKS AND UNCERTAINTIES 15
FINANCIAL REVIEW 15
FINANCIAL STATEMENTS 22
NOTES TO THE FINANCIAL STATEMENTS 26
ABOUT GENMAB 34
DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT 35
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 3/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
CONSOLIDATED KEY FIGURES
Three Months Ended Nine Months Ended
(DKK million) September 30, September 30, Full Year
Income Statement 2022 2021 2022 2021 2021
Revenue 4,087 2,310 9,368 5,863 8,482
Research and development expenses (1,486) (1,114) (3,921) (2,883) (4,181)
Selling, general and administrative expenses (670) (306) (1,755) (771) (1,283)
Operating expenses (2,156) (1,420) (5,676) (3,654) (5,464)
Operating profit 1,931 890 3,692 2,209 3,018
Net financial items 1,341 281 2,681 808 965
Net profit 2,582 890 4,938 2,292 3,008
Balance Sheet
Marketable securities 13,411 10,014 13,411 10,014 10,381
Cash and cash equivalents 10,377 8,729 10,377 8,729 8,957
Total non-current assets 1,947 2,031 1,947 2,031 1,891
Total assets 30,686 23,985 30,686 23,985 24,627
Shareholders' equity 26,657 21,285 26,657 21,285 22,196
Share capital 66 66 66 66 66
Cash Flow Statement
Cash flow from operating activities 1,968 447 3,514 1,987 2,228
Cash flow from investing activities (1,382) (1,621) (2,625) (655) (961)
Cash flow from financing activities (642) 24 (920) (436) (420)
Investment in tangible assets (82) (77) (207) (184) (252)
Financial Ratios and Other Information
Basic net profit per share 39.55 13.61 75.48 35.05 46.00
Diluted net profit per share 39.17 13.47 74.83 34.72 45.54
Period-end share market price 2,461 2,809 2,461 2,809 2,630
Price / book value 6.09 8.71 6.09 8.71 7.82
Shareholders' equity per share 403.89 322.50 403.89 322.50 336.30
Equity ratio 87 % 89 % 87 % 89 % 90 %
Shares outstanding 65,829,282 65,685,053 65,829,282 65,685,053 65,718,456
Average number of employees (FTE*) 1,516 1,089 1,402 967 1,022
Number of employees (FTE) at the end of the period 1,560 1,136 1,560 1,136 1,212
* Full-time equivalent or team members
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 4/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
Revised Previous
(DKK million) Guidance Guidance
Revenue 13,500 - 14,500 12,000 - 13,000
Operating expenses (8,000) - (8,400) (7,600) - (8,200)
Operating profit 5,100 - 6,500 3,800 - 5,400
Genmab is improving its 2022 financial guidance published on August 8, 2022, driven primarily by the positive foreign exchange rate impact on our royalty revenue, and the continued strong performance of DARZALEX net sales.
Genmab expects its 2022 revenue to be in the range of DKK 13,500 - 14,500 million, an increase to the previous guidance of DKK 12,000 - 13,000 million, driven primarily by the positive foreign exchange rate impact on our royalty revenue, and the continued strong performance of DARZALEX net sales. Genmab's projected revenue for 2022 primarily consists of DARZALEX royalties of DKK 10,000 - 10,300 million compared to the previous guidance of DKK 8,800 - 9,300 million. Such royalties are based on Genmab's revised estimate of DARZALEX 2022 net sales of USD 8.0 - 8.2 billion compared to the previous guidance of USD 7.8 - 8.2 billion. DARZALEX royalties are partly offset by Genmab's share of Janssen's royalty payments to Halozyme in connection with subcutaneous (SC) net sales. The upper end of the revenue guidance range now assumes a significant milestone associated with the potential acceptance by the U.S. FDA to review the BLA submission for epcoritamab. The remainder of Genmab's revenue primarily consists of royalties from TEPEZZA, Kesimpta and RYBREVANT , reimbursement revenue, milestones including those for epcoritamab and teclistamab as well as collaboration revenue with Seagen Inc. (Seagen) for Tivdak.
Genmab anticipates its 2022 operating expenses to be in the range of DKK 8,000 - 8,400 million, an increase to the previous guidance of DKK 7,600 - 8,200 million, primarily driven by the negative impact of the strong U.S. Dollar. Operating expenses continue to be driven by the advancement of Genmab's clinical programs, continued investment in research and development, as well as building Genmab's commercial organization and broader organizational infrastructure.
Genmab now expects its 2022 operating profit to be in the range of DKK 5,100 - 6,500 million, an increase to the previous guidance of DKK 3,800 - 5,400 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, Kesimpta, TEPEZZA, RYBREVANT and TECVAYLI net sales and royalties paid to Genmab; and currency exchange rates (the 2022 guidance assumes a USD / DKK exchange rate of 7.2 compared to 6.8 in the previous guidance). The financial guidance assumes that no significant new agreements are entered into during the remainder of 2022 that could materially affect the results. Refer to the section "Significant
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 5/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
Risks and Uncertainties" in this interim report. Additionally, depending on trends related to the coronavirus and future variants, the COVID-19 pandemic could potentially have a material adverse impact on Genmab's business and financial performance, including clinical trials, projected regulatory approval timelines, supply chain and revenues, and cause Genmab's actual results to differ materially from 2022 Guidance and Key 2022 Priorities in this interim report.
Should the global outbreak of COVID-19 persist, it may have long-term impacts on the development, regulatory approval and commercialization of Genmab's investigational medicines and on net sales of approved medicines created by Genmab and developed and marketed by Genmab or Genmab's collaboration partners. As the pandemic continues, there may be an impact on Genmab's business. Genmab has an established COVID-19 response team, led by the CEO, that closely monitors the evolving situation, maintains precautionary measures to help limit the impact of COVID-19 at the workplace and on our communities, and ensures business continuity. The full extent and nature of the impact of the COVID-19 pandemic and related containment measures on Genmab's business and financial performance is uncertain as the situation continues. 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 on net sales of DARZALEX, Kesimpta, TEPEZZA, RYBREVANT and TECVAYLI by Genmab's partners and on Genmab's royalty, milestone and collaboration revenue therefrom.
Priority Targeted Milestones
Broad and rapid development of late-stage clinical pipeline and further build US country organization Epcoritamab 1 Expand clinical development program with multiple Phase 3 trials initiated and submission of first BLA (subject to supportive FDA feedback)
Tivdak 2 Establish Tivdak as a clear choice for 2L+ r/m Cervical Cancer patients Broaden clinical development program including Phase 2 evaluation of combination therapy in earlier line treatment for cervical cancer and other solid tumors
Growth and development of differentiated early-stage product candidates DuoBody -PD-L1x4-1BB 3 & DuoBody-CD40x4-1BB 3 Data from clinical expansion cohorts to progress to next steps
Expand and advance proprietary clinical product portfolio
Further scale organization aligned with growing product portfolio and brand needs Further scale organization aligned with differentiated antibody product portfolio growth and future launches
Use solid financial base to grow and broaden antibody product and technology portfolio
1. Co-development w/ AbbVie; 2. Co-development w/ Seagen; 3. Co-development w/ BioNTech
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 6/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2022
At the end of the first nine months of 2022, Genmab's proprietary pipeline of investigational medicines, where we are responsible for at least 50% of development, consisted of eight antibody products in clinical development. These include Genmab's first U.S. FDA approved medicine, Tivdak, that Genmab is co-developing and co-promoting in the U.S. with Seagen. 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 preclinical programs. An overview of the development status of each of our investigational medicines is provided in the following sections, including updates for the third quarter of 2022. For events that occurred during the first and second quarters of 2022, please refer to Genmab's Q1 2022 and Q2 2022 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 stock exchange and may also be found in Genmab's filings with the U.S. Securities and Exchange Commission (SEC). Additional information is available on Genmab's website, www.genmab.com. The information accessible through our website is not part of this report and is not incorporated by reference herein.
Genmab Proprietary Investigational Medicines1 in Development
1Investigational medicines where Genmab has 50% ownership. Certain investigational medicines in co-development, partners as indicated
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 7/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
2See U.S. prescribing information for precise indication and safety information
3In June 2022, AbbVie decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of the notice period, Genmab will become solely responsible for the further development of DuoHexaBody-CD37 against low-single digit royalty payments to AbbVie, up to an agreed maximum total royalty amount, based on future potential sales of the product.
4Genmab 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
Tivdak 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 Tivdak. 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. Tivdak 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 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 on the worldwide development and commercialization strategy for Tivdak. The companies have a broad clinical development program for Tivdak, including a confirmatory Phase 3 study in recurrent or metastatic cervical cancer.
Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety information, including the boxed warning.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 8/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
Epcoritamab (DuoBody-CD3xCD20) - Potential Best-in-class Investigational Medicine
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 well-validated target on malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab. Epcoritamab is being co-developed by Genmab and AbbVie. The companies have a broad clinical development program for epcoritamab including two ongoing Phase 3 studies with multiple others in planning. The combination of epcoritamab and DuoHexaBody-CD37 (GEN3009) is also being explored in an arm of a Phase 1/2 clinical study (NCT04358458) of DuoHexaBody-CD37 in hematologic malignancies.
Third Quarter 2022 Updates
DuoBody-PD-L1x4-1BB (GEN1046/BNT311) - Bispecific Next Generation Checkpoint Immunotherapy
DuoBody-PD-L1x4-1BB 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 DuoBody-PD-L1x4-1BB on a 50:50 basis. DuoBody-PD-L1x4-1BB 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 studies in solid tumors are ongoing including a Phase 2 study of DuoBody-PD-L1x4-1BB as monotherapy or in combination with pembrolizumab in patients with recurrent metastatic NSCLC.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 9/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
DuoBody-CD40x4-1BB (GEN1042/BNT312) - Potential First-in-Class Bispecific Agonistic Antibody
DuoBody-CD40x4-1BB 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 DuoBody-CD40x4-1BB 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. A Phase 1/2 clinical study of DuoBody-CD40x4-1BB in solid tumors is ongoing.
HexaBody-CD27 (GEN1053/BNT313) - First-in-Human Study Recruiting
HexaBody-CD27 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 the 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 HexaBody-CD27 on a 50:50 basis. A Phase 1/2 clinical study of HexaBody-CD27 in solid tumors is recruiting.
DuoHexaBody-CD37 (GEN3009) - First DuoHexaBody Program in the Clinic
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. In June 2022 AbbVie decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of the notice period, Genmab will become solely responsible for the further development of DuoHexaBody-CD37 against low-single digit royalty payments to AbbVie, up to an agreed maximum total royalty amount, based on future potential sales of the product. A Phase 1/2 clinical study in hematologic malignancies, including an arm in combination with epcoritamab, is ongoing.
HexaBody-CD38 (GEN3014) - HexaBody Molecule with Potential in Hematological Malignancies
HexaBody-CD38 is a human CD38 monoclonal antibody-based investigational medicine created using Genmab's HexaBody technology platform. In preclinical models of hematological malignancies HexaBody-CD38 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
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 10/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
with Janssen to develop and commercialize HexaBody-CD38. A Phase 1/2 clinical study in hematologic malignancies is ongoing.
DuoBody-CD3xB7H4 (GEN1047) - Bispecific with Potential in Solid Tumors
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 preclinical studies, DuoBody-CD3xB7H4 induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. DuoBody-CD3xB7H4 is being developed for the potential treatment of solid cancer indications known to express B7H4. A Phase 1/2 clinical study of DuoBody-CD3xB7H4 in malignant solid tumors is ongoing.
Products 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.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 11/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
*See local country prescribing information for precise indications and safety information
DARZALEX (daratumumab) - Redefining the Treatment of Multiple Myeloma
DARZALEX 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 forming part of daratumumab. Daratumumab is being developed by Janssen under an exclusive worldwide license from Genmab to develop, manufacture and commercialize daratumumab. Under the terms of the agreement, Genmab is entitled to double digit royalties between 12% and 20% with Janssen reducing such royalty payments for Genmab's share of Janssen's royalty payments made to Halozyme Therapeutics, Inc. (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.
Kesimpta (ofatumumab) - Approved in treatment of relapsing forms of multiple sclerosis (RMS)
Kesimpta is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of Kesimpta. 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. Kesimpta is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis. Under the terms of the agreement, Genmab is entitled to 10% royalties on net sales of Kesimpta.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 12/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
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 thyroid eye disease (TED)
Teprotumumab, 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 well-validated target. Genmab used technology licensed from Medarex to generate the IGF-1R antibody forming part of teprotumumab. The antibody was created by Genmab under a collaboration with Roche and development and commercialization of the product is now being conducted by Horizon under a sublicense from Roche. Under the terms of Genmab's agreement with Roche, Genmab will receive mid-single digit royalties on net sales of TEPEZZA.
Please consult the U.S. Prescribing Information for the labeled indication and safety information for TEPEZZA.
RYBREVANT (amivantamab-vmjw) - First regulatory approvals for a DuoBody-based Medicine
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab's DuoBody technology platform. One of these, Janssen's RYBREVANT, is a fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and Met, 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 create amivantamab was selected. Janssen is responsible for the development and commercialization of amivantamab.
In 2021, Janssen received approvals in the U.S., Europe and other markets for RYBREVANT for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations. These were the first regulatory approvals for a therapy that was created using Genmab's proprietary DuoBody bispecific technology platform. Under our agreement with Janssen, Genmab will receive milestones and royalties between 8% and 10% on net sales of RYBREVANT.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics for RYBREVANT for the labeled indication and safety information.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 55
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 13/35
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the First Nine Months of 2022
TECVAYLI (teclistamab) - Approved in Europe for the treatment of relapsed and refractory multiple myeloma
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab's DuoBody technology platform. One of the products subsequently created, discovered and developed by Janssen is TECVAYLI, a bispecific antibody that targets CD3, which is expressed on T-cells and B-cell maturation antigen (BCMA), which is expressed in mature B lymphocytes.
In August 2022, Janssen received conditional marketing authorization from the European Commission for subcutaneously administered TECVAYLI as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. TECVAYLI is the second therapy created using Genmab's proprietary DuoBody bispecific technology platform to receive regulatory approval. Under our agreement with Janssen, Genmab will receive milestones and mid-single digit royalties on net sales of TECVAYLI.
Last updated: Nov 9, 2022