On August 3, 2023 Genmab reported Interim Results for the First Six Months Ended June 30, 2023 (Press release, Genmab, AUG 3, 2023, View Source [SID1234633745]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.