November 6, 2024 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2024
Highlights
- European Commission (EC) granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
- Genmab announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab
- Genmab revenue increased 29% compared to the first nine months of 2023, to DKK 15,085 million
- Genmab 2024 financial guidance updated
"The third quarter of 2024 presented Genmab with additional opportunities to progress towards our goal of fundamentally transforming the lives of people with cancer and other serious diseases. The additional approval for TEPKINLY, along with positive data presentations for our promising late-stage assets acasunlimab and rinatabart sesutecan (Rina-S), underscore the potential of our pipeline and our commitment to the development of innovative antibody-based therapeutics," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2024
- Revenue was DKK 15,085 million for the first nine months of 2024 compared to DKK 11,715 million for the first nine months of 2023. The increase of DKK 3,370 million, or 29%, 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® (epcoritamab) net product sales.
- Royalty revenue was DKK 12,367 million in the first nine months of 2024 compared to DKK 9,722 million in the first nine months of 2023, an increase of DKK 2,645 million, or 27%. 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 8,586 million in the first nine months of 2024 compared to USD 7,194 million in the first nine months of 2023, an increase of USD 1,392 million or 19%.
- Total costs and operating expenses were DKK 10,542 million in the first nine months of 2024 compared to DKK 8,145 million in the first nine months of 2023. The increase of DKK 2,397 million, or 29%, was driven by the expansion of our product pipeline, including the addition of ProfoundBio related research and development expenses, primarily Rina-S, 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 4,543 million in the first nine months of 2024 compared to DKK 3,570 million in the first nine months of 2023.
- Net financial items resulted in income of DKK 1,019 million for the first nine months of 2024 compared to DKK 1,060 million in the first nine months of 2023.
Outlook
Genmab is updating the lower end of its revenue range of 2024 financial guidance driven by higher total royalty revenues from DARZALEX. Genmab is also lowering the upper end of its operating expense range to reflect a continued focused and disciplined approach to investments and portfolio prioritization.
| (DKK million) | Revised Guidance | Previous Guidance | |
| Revenue | 21,100 - 21,700 | 20,500 - 21,700 | |
| Royalties | 17,000 - 17,400 | 16,600 - 17,400 | |
| Net product sales/Collaboration revenue* | 2,000 - 2,200 | 2,000 - 2,200 | |
| Milestones/Reimbursement revenue | 2,100 - 2,100 | 1,900 - 2,100 | |
| Gross profit** | 20,200 - 20,800 | 19,600 - 20,800 | |
| Operating expenses** | (13,700) - (14,000) | (13,700) - (14,300) | |
| Including Acquisition & Integration Related Charges | (14,100) - (14,400) | (14,100) - (14,700) | |
| Operating profit | 6,200 - 7,100 | 5,300 - 7,100 | |
| Including Acquisition & Integration Related Charges | 5,800 - 6,700 | 4,900 - 6,700 |
*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 nine of 2024 today, November 6, 2024, 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/BI6db06ed786914762a9dc001f798b7c1b. 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
The Interim Report contains forward looking statements. The words "believe," "expect," "anticipate," "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect® and KYSO®; Tivdak® is a trademark of Seagen Inc.; EPCORE, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.
Download the full Interim Report for the First Nine Months of 2024 on attachment or at www.genmab.com/investor-relations.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark
