
Genmab Announces Financial Results for the First Quarter of 2024
Company Announcement no. 33
May 2, 2024 Copenhagen, Denmark;
Interim Report for the First Quarter Ended March 31, 2024
Highlights
• The U.S. Food and Drug Administration (U.S. FDA) granted Priority Review for the
supplemental Biologics License Application (sBLA) for EPKINLY
®
(epcoritamab-bysp) for
the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after
two or more lines of systemic therapy, with a Prescription Drug User Fee Act (PDUFA)
target action date of June 28, 2024
• An additional Phase 3 clinical trial was initiated, evaluating epcoritamab in combination
with rituximab and lenalidomide compared to chemoimmunotherapy in previously
untreated follicular lymphoma
• The U.S. FDA accepted for Priority Review the sBLA seeking to convert the accelerated
approval of Tivdak
®
(tisotumab vedotin-tftv) to full approval, for the treatment of patients
with recurrent or metastatic cervical cancer with disease progression on or after first-line
therapy
• Genmab announced the decision of its arbitration appeal under its daratumumab license
agreement with Janssen Biotech, Inc. (Janssen)
• Genmab revenue increased 46% compared to the first quarter of 2023, to DKK 4,143
million
“The acceptance for Priority Review by the U.S. FDA of the sBLAs for EPKINLY and Tivdak that we
received in the first quarter are important events that support our commitment to continue to deliver
innovative treatment options that have the potential to profoundly impact the lives of patients. These
regulatory acceptances for priority review also reflect our dedication to working with our partners, AbbVie
Inc. (AbbVie) and Pfizer Inc. (Pfizer) to expand the labels for EPKINLY and Tivdak, respectively, in order
to maximize the potential of both medicines and bring them to as many patients in need of alternative
therapeutic options as possible,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter of 2024
• Revenue was DKK 4,143 million for the first three months of 2024 compared to DKK 2,834 million
for the first three months of 2023. The increase of DKK 1,309 million, or 46%, was primarily
driven by higher DARZALEX
®
and Kesimpta
®
royalties achieved under our collaborations with
Janssen and Novartis Pharma AG (Novartis), respectively, EPKINLY net product sales, and a
milestone achieved under our collaboration with AbbVie.
• Royalty revenue was DKK 3,104 million in the first three months of 2024 compared to DKK 2,408
million in the first three months of 2023, an increase of DKK 696 million, or 29%. The increase in
royalties was driven by higher net sales of DARZALEX and Kesimpta.
• Net sales of DARZALEX (daratumumab), 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 2,692 million in the first three months of 2024 compared to USD
2,264 million in the first three months of 2023, an increase of USD 428 million or 19%.
• Total costs and operating expenses were DKK 3,342 million in the first three months of 2024
compared to DKK 2,417 million in the first three months of 2023. The increase of DKK 925
million, or 38%, 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