The U.S. FDA approval of EPKINLY as the first bispecific antibody to treat adults with relapsed or refractory DLBCL was an important milestone both for Genmab and for patients in need of an innovative treatment option administered subcutaneously.
August 3, 2023 Copenhagen, Denmark;
Interim Report for the First Six Months Ended June 30, 2023
Highlights
- EPKINLY™ (epcoritamab-bysp) was approved by the U.S. Food and Drug Administration (U.S. FDA) as the first bispecific antibody to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
- Genmab and AbbVie Inc. (AbbVie) announced positive topline results from the Phase 1/2 EPCORE™ NHL-1 trial evaluating epcoritamab in patients with relapsed/refractory follicular lymphoma (FL)
- Genmab revenue increased 34% compared to the first six months of 2022, to DKK 7,052 million
- Genmab 2023 financial guidance updated
“The U.S. FDA approval of EPKINLY as the first bispecific antibody to treat adults with relapsed or refractory DLBCL was an important milestone both for Genmab and for patients in need of an innovative treatment option administered subcutaneously. We would like to thank the patients and investigators who took part in the EPCORE NHL-1 trial that was the basis of this approval, as well as the unstoppable team at Genmab responsible for the discovery, development and now commercialization of EPKINLY. We also thank our partners at AbbVie for their excellent collaboration as we work together to bring EPKINLY to cancer patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2023
- Net sales of DARZALEX® by Janssen Biotech, Inc. (Janssen) were USD 4,695 million in the first six months of 2023 compared to USD 3,842 million in the first six months of 2022, an increase of USD 853 million, or 22%.
- Royalty revenue was DKK 5,935 million in the first six months of 2023 compared to DKK 4,727 million in the first six months of 2022, an increase of DKK 1,208 million, or 26%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta®.
- Revenue was DKK 7,052 million for the first six months of 2023 compared to DKK 5,281 million for the first six months of 2022. The increase of DKK 1,771 million, or 34%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis Pharma AG (Novartis), respectively, a milestone achieved under our collaboration with AbbVie for the first commercial sale of EPKINLY in the United States, and higher reimbursement revenue driven by increased activities under our collaboration with BioNTech SE (BioNTech).
- Operating expenses were DKK 5,118 million in the first six months of 2023 compared to DKK 3,520 million in the first six months of 2022. The increase of DKK 1,598 million, or 45%, was driven by the expansion of our product pipeline, EPKINLY launch in the U.S., the continued development of Genmab’s broader organizational capabilities, and related increase in team members to support these activities.
- Operating profit was DKK 1,934 million in the first six months of 2023 compared to DKK 1,761 million in the first six months of 2022.
- Net financial items resulted in income of DKK 75 million for the first six months of 2023 compared to DKK 1,340 million in the first six months of 2022. The decrease of DKK 1,265 million, or 94%, was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab’s USD denominated cash and cash equivalents, and marketable securities in the respective periods.
Outlook
As announced in Company Announcement No. 36, Genmab updated its 2023 financial guidance driven by the continued strong growth of DARZALEX net sales and higher total royalty revenues from DARZALEX and other marketed products, partly offset by increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.
| Revised | Previous | |||
| (DKK million) | Guidance | Guidance | ||
| Revenue | 15,500 - 16,500 | 14,600 - 16,100 | ||
| Operating expenses | (10,400) - (10,900) | (9,800) - (10,600) | ||
| Operating profit | 4,500 - 6,000* | 3,900 - 6,200* |
*Operating profit does not sum due to rounding
Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2023 today, Thursday, August 3, 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/BI9658367403a443db8fda64d31a3cfbc5. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
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 pre-clinical 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®; and HexElect®. Tivdak® is a trademark of Seagen Inc.;EPCORE™ and EPKINLY™ are trademarks of AbbVie Biotechnology Ltd.; Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT® and TECVAYLI® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.
Download the full Interim Report for the First Half of 2023 on attachment or at www.genmab.com/investors.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark
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