Ofatumumab

Elevated levels of neurofilament light chain are also being studied across a range of neurological conditions, where damaged nerve cells serve as a hallmark of the disease, such as dementia, Alzheimer's and ALS. Siemens Healthineers received European approval for a blood test designed to help predict the risk of recurrence among patients with relapsing multiple sclerosis.  The company’s CE-marked in vitro diagnostic measures the amount of neurofilament light chain proteins found in serum and plasma, which are released into the bloodstream when the brain’s neurons are under siege. When combined with MRI brain scans and other clinical lab tests, it aims to predict which adult patients may have a higher or lower risk of MS disease activity within the following two years. “Neurofilament light chain, or NfL, has emerged as a leading biomarker of nerve cell damage,” Siemens Healthineers’ head of diagnostics R&D, Dennis Gilbert, said in a statement. “Having access to a test that measures this protein capable of crossing the blood-brain barrier to support earlier prognostication of disease activity would be a critical scientific advancement for MS patients.” The test—run on the company’s Atellica IM and the ADVIA Centaur analyzers—is the result of a years-long collaboration with Novartis, which launched in 2020 shortly after the drugmaker received an FDA approval for its Kesimpta therapy for relapsing-remitting and secondary progressive MS. Novartis would also go on to collect the first U.S. green light for a biosimilar MS drug, with its version of Biogen’s blockbuster Tysabri. “While there is no cure for MS, treatments exist to decrease the frequency of relapses, thought to be associated with nerve cell damage and disease progression,” Gilbert said. “What patients still need is an easily accessible, cost-effective, and accurate blood-based test that would indicate early signs of neuronal injury and disease activity.” Elevated levels of neurofilament light chain, in both the blood and cerebrospinal fluid, are also being studied across a range of neurological conditions where damaged nerve cells serve as a hallmark of the disease—such as dementia and amyotrophic lateral sclerosis, the motor neuron disease commonly known as ALS.  Meanwhile, NfL was incorporated into Labcorp’s blood test aimed at Alzheimer’s disease last fall, alongside measurements of hallmark amyloid and tau proteins. 

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 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, Inc. 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: . A live and archived webcast of the call and relevant slides will be available at . Contact Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs T: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com The Interim Report contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at . Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect® and KYSO®; Tivdak® is a trademark of Seagen Inc.;EPCORE™, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, TECVAYLI® and TALVEY®are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Quarter of 2024 on attachment or at . CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 020524_CA33_Genmab Q1 2024 Interim Report