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, 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 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
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 Half 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
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