On November 7, 2023 Genmab reported Interim Results for the First Nine Months Ended September 30, 2023 (Press release, Genmab, NOV 7, 2023, View Source [SID1234637137]).

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Highlights

Epcoritamab (TEPKINLY) was granted conditional marketing authorization by the European Commission (EC) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Epcoritamab (EPKINLY) was approved by the Japan Ministry of Health, Labour and Welfare to treat adults with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
Genmab and Seagen Inc. (Seagen) announced that the Phase 3 innovaTV 301 confirmatory trial of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer met its primary endpoint of improved overall survival (OS) at a predetermined, independent interim analysis
Genmab revenue increased 26% compared to the first nine months of 2022, to DKK 11,796 million
Genmab 2023 financial guidance updated
"With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY is the first Genmab-owned medicine to become available to patients outside of the United States. In addition to being an important milestone for Genmab, these approvals mark an important milestone for patients in these territories who are in need of alternative therapeutic options," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to continue to work with our partner, AbbVie Inc. (AbbVie), to further explore epcoritamab as a potential future core therapy across B-cell malignancies."

Financial Performance First Nine Months of 2023

Net sales of DARZALEX by Janssen Biotech, Inc. (Janssen) were USD 7,194 million in the first nine months of 2023 compared to USD 5,894 million in the first nine months of 2022, an increase of USD 1,300 million, or 22%.
Royalty revenue was DKK 9,803 million in the first nine months of 2023 compared to DKK 8,207 million in the first nine months of 2022, an increase of DKK 1,596 million, or 19%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta, partly offset by negative foreign exchange rate impacts due to a lower average exchange rate between the USD and DKK.
Revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368 million for the first nine months of 2022. The increase of DKK 2,428 million, or 26%, 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 8,045 million in the first nine months of 2023 compared to DKK 5,676 million in the first nine months of 2022. The increase of DKK 2,369 million, or 42%, 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 3,651 million in the first nine months of 2023 compared to DKK 3,692 million in the first nine months of 2022.
Net financial items resulted in income of DKK 1,060 million for the first nine months of 2023 compared to DKK 2,681 million in the first nine months of 2022. The decrease of DKK 1,621 million, or 60%, 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
Genmab is updating the lower end of its revenue and operating expenses of its 2023 financial guidance driven by higher total royalty revenues from DARZALEX and other marketed products and increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Revised Previous
(DKK million) Guidance Guidance
Revenue 15,900 – 16,500 15,500 – 16,500
Operating expenses (10,600) – (10,900) (10,400) – (10,900)
Operating profit* 4,800 – 5,750 4,500 – 6,000
*Operating profit includes DKK~0.2 billion of cost of product sales, which is not classified within operating expenses

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2023 today, Tuesday, November 7, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. 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/BIa45c5d7cd5384835a879e0ab083d0577. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.