On May 2, 2024 Genmab reported Interim Report for the First Quarter Ended March 31, 2024 (Press release, Genmab, MAY 2, 2024, View Source [SID1234642585]).

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

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 capabilities and related increase in team members to support these activities, as well as profit-sharing amounts payable to AbbVie related to EPKINLY sales.
Operating profit was 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. The increase of DKK 1,066 million was primarily driven by movements in USD to DKK foreign exchange rates impacting Genmab’s USD denominated cash and cash equivalents and marketable securities, with strengthening of the USD/DKK rate in the first three months of 2024 compared to the weakening of the USD/DKK rate in the first three months of 2023.
Subsequent Event

April: Genmab and ProfoundBio, Inc. (ProfoundBio) announced that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. The acquisition will give Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses). The proposed transaction is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.

Outlook
Genmab is maintaining its 2024 financial guidance published on February 14, 2024.

Following the announcement of the proposed acquisition of ProfoundBio, Genmab’s operating expenses before expenses incurred by it in connection with the proposed transaction are now anticipated to be at or moderately above the upper end of the previously disclosed guidance range of DKK 12.4 -13.4 billion. The anticipated increase reflects the incremental R&D investment to support the advancement of ProfoundBio’s clinical programs, primarily Rina-S. Genmab’s revenue guidance is unchanged and expected to be in the previously disclosed guidance range of DKK 18.7 – 20.5 billion.

We expect to update our guidance no later than in connection with our second quarter 2024 earnings.

Conference Call
Genmab will hold a conference call to discuss the results for the first quarter of 2024 today, Thursday, May 2, 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/BIcaf0da755ddb4d7f81f4dd2c0229135e. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.