Genmab Reports Q1 2024 Financial Results

On May 2, 2024, Genmab A/S, headquartered in Copenhagen, Denmark, announced its Interim Report for the first quarter ending March 31, 2024. 

Key Highlights:
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). This application pertains to treating adult patients with relapsed or refractory follicular lymphoma (FL) who have previously undergone two or more lines of systemic therapy. The target action date under the Prescription Drug User Fee Act (PDUFA) is set for June 28, 2024. 

Additionally, a new Phase 3 clinical trial was initiated to evaluate the efficacy of epcoritamab in combination with rituximab and lenalidomide, compared to chemoimmunotherapy in patients with previously untreated follicular lymphoma. The U.S. FDA has also accepted an sBLA for Priority Review, seeking to convert the accelerated approval of Tivdak® (tisotumab vedotin-tftv) to full approval. This treatment is intended for patients with recurrent or metastatic cervical cancer who have experienced disease progression after first-line therapy.

Genmab also reported a decision on its arbitration appeal under its daratumumab license agreement with Janssen Biotech, Inc. (Janssen).

Financial Performance:
For the first quarter of 2024, Genmab reported a revenue of DKK 4,143 million, a 46% increase compared to DKK 2,834 million in the same period in 2023. This growth was driven primarily by higher royalties from DARZALEX® and Kesimpta®, collaborations with Janssen and Novartis Pharma AG (Novartis), net product sales of EPKINLY, and a milestone achieved under their collaboration with AbbVie. 

Royalty revenue stood at DKK 3,104 million, marking a 29% increase from DKK 2,408 million in the first quarter of 2023. This rise was attributed to higher net sales of DARZALEX and Kesimpta. DARZALEX's net sales, including its subcutaneous product sold under the tradename DARZALEX FASPRO® in the U.S., reached USD 2,692 million, up by USD 428 million or 19% from USD 2,264 million in the first quarter of 2023.

Total costs and operating expenses for the first three months of 2024 were DKK 3,342 million, a 38% rise from DKK 2,417 million in the same period the previous year. This increase was driven by the expansion of Genmab's product pipeline, post-launch activities of EPKINLY in the U.S. and Japan, the growth of broader organizational capabilities, and related profit-sharing amounts payable to AbbVie associated with EPKINLY sales.

Operating profit for the first quarter of 2024 was DKK 801 million, compared to DKK 417 million in the same period in 2023. Net financial items resulted in an income of DKK 915 million for the first three months of 2024, a significant rise from an expense of DKK 151 million in the first quarter of 2023. This increase was largely due to movements in the USD to DKK foreign exchange rates, which impacted Genmab’s USD denominated cash and cash equivalents and marketable securities.

Subsequent Event:
In April, Genmab announced a definitive agreement to acquire ProfoundBio, Inc. in an all-cash transaction valued at USD 1.8 billion. This acquisition will provide Genmab with worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), along with ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms. The transaction is expected to close in the first half of 2024, subject to customary closing conditions.

Outlook:
Genmab is maintaining its 2024 financial guidance as published on February 14, 2024. Following the proposed acquisition of ProfoundBio, operating expenses before costs related to the transaction are anticipated to be at or above the upper end of the previously disclosed range of DKK 12.4 - 13.4 billion. This reflects increased R&D investment to advance ProfoundBio’s clinical programs, primarily Rina-S. Revenue guidance remains unchanged and is expected to be within the previously disclosed range of DKK 18.7 – 20.5 billion. Updated guidance will be provided by the second quarter of 2024.

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