The U.S. Food and Drug Administration (U.S. FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) for EPKINLY® (epcoritamab-bysp) aimed at treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The Prescription Drug User Fee Act (PDUFA) target action date is set for June 28, 2024. Additionally, an additional Phase 3 clinical trial has been initiated to evaluate epcoritamab in combination with rituximab and lenalidomide compared to chemoimmunotherapy in previously untreated follicular lymphoma.
Furthermore, the U.S. FDA has accepted for Priority Review the sBLA seeking to convert the accelerated approval of Tivdak® (tisotumab vedotin-tftv) to full approval. This is for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. Genmab also announced the resolution of its arbitration appeal under its daratumumab license agreement with Janssen Biotech, Inc. (Janssen).
In terms of financial performance, Genmab reported a 46% increase in revenue compared to the first quarter of 2023, reaching DKK 4,143 million. This growth was primarily driven by higher royalties from DARZALEX® and Kesimpta® under collaborations with Janssen and Novartis Pharma AG, respectively, as well as EPKINLY net product sales and a milestone achieved under the collaboration with AbbVie.
However, total costs and operating expenses also increased by 38% to DKK 3,342 million in the first three months of 2024 compared to the same period in 2023. This was attributed to pipeline expansion, EPKINLY post-launch activities, organizational capabilities development, and profit-sharing amounts payable to AbbVie related to EPKINLY sales.
Genmab’s operating profit reached DKK 801 million in the first three months of 2024 compared to DKK 417 million in the first three months of 2023. Net financial items resulted in income of DKK 915 million for the first three months of 2024, compared to an expense of DKK 151 million in the first three months of 2023, primarily driven by foreign exchange rate movements.
In a subsequent event, Genmab announced the acquisition of ProfoundBio, Inc. for USD 1.8 billion in cash, which is expected to close in the first half of 2024. This acquisition will provide Genmab with worldwide rights to three candidates in clinical development and ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms.
Despite the acquisition, Genmab is maintaining its 2024 financial guidance, although operating expenses before expenses incurred in connection with the acquisition are anticipated to be at or moderately above the upper end of the previously disclosed guidance range. This reflects incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. The revenue guidance remains unchanged and is expected to be in the previously disclosed range.
For more information, Genmab will hold a conference call to discuss the results for the first quarter of 2024. Contact details for Marisol Peron and Andrew Carlsen are provided for further inquiries.
