Daratumumab/Hyaluronidase-fihj

The FDA on Thursday handed an accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide) to treat certain patients with multiple myeloma (MM), marking several firsts. The drug is the first in a new class of next-generation immunomodulatory drugs (IMiDs), called cereblon E3 ligase modulators (CELMoDs), to be greenlit by the US regulator. Specifically, the drug was cleared in combination with the subcutaneous formulation of Johnson & Johnson's CD38-directed antibody, Darzalex Faspro (daratumumab and hyaluronidase-fihj), and dexamethasone for adults with MM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.Zenbexus was approved based on data from the Phase II EXCALIBER-RRMM trial — and BMS's accompanying announcement was the first time specific findings from the study have been disclosed. In September, the pharma shared that Zenbexus met one of its dual primary endpoints in EXCALIBER-RMM by significantly improving the rate of minimal residual disease (MRD)-negativity compared with a regimen including Darzalex, bortezomib and dexamethasone (DVd). While BMS didn't disclose many details, experts were confident in Zenbexus because of its potency as a CELMoD (see – Spotlight On: US approval nears for Bristol Myers Squibb's new myeloma drug).Now, BMS has shared to what degree the drug improved MRD-negativity. At a median follow-up of 16 months in the EXCALIBER-RRMM trial, 85 of the 207 patients (41%) taking the Zenbexus regimen achieved a MRD-negative complete response (CR), compared with 44 of 213 participants (21%) in the DVd arm, a statistically significant result (p < 0.0001). In regards to safety, Zenbexus features a boxed warning for embryo-fetal toxicity and venous and arterial thromboembolism. BMS noted that the oral drug can cause serious, life-threatening, or fatal infections and severe neutropenia, though the most common adverse events (AEs) occurring in 20% or more of patients were fatigue, musculoskeletal pain, pneumonia, diarrhoea, motor dysfunction, rash, sleep disorder, and hypogammaglobulinemia. Fatal adverse reactions occurred in 10 patients who received Zenbexus, while several serious AEs were reported, including pneumonia (26%), upper respiratory tract infection (6.4%), second primary malignancy (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%) and sepsis (2.9%).MRD-negativity The FDA OK for Zenbexus is also the agency's first approval based on MRD-negative CR. According to BMS, MRD-negativity — which measures how thoroughly cancer cells are eradicated — is "among the deepest measures of response" for MM and could be predictive of progression-free survival. An FDA advisory panel last year unanimously backed MRD as a feasible surrogate, and a subsequent FirstWord survey found nearly 90% of US oncologists consider it a reliable predictor of long-term outcomes.Behind Zenbexus, BMS has another CELMoD under review with the FDA for MM, with a PDUFA date of May 13, 2027.At this year's American Society of Clinical Oncology (ASCO) meeting, BMS reported that mezigdomide achieved a significant 52% reduction in the risk of disease progression or death in patients with relapsed or refractory MM.

August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million Genmab 2026 financial guidance updated “The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S® (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2026 Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties and higher EPKINLY® net product sales. Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY® were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%. Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales. Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches. Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026. Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform. Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025. Outlook Genmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY. 2026 FULL YEAR OUTLOOK 1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak® ex-U.S. net product sales plus Genmab's share of U.S. gross profits. 2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million. 3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million. Non-IFRS Financial Measures Our Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Conference Call Genmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, 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-conf.media-server.com/register/BId9cf2ff8aa3c489ca2ad2007d64a1964. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations. 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 www.genmab.com 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 www.sec.gov. 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®; KYSO®, RAINFOL™, ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Biclonics® and BIZENGRI® are registered trademarks of Merus N.V. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, RYBREVANT FASPRO™,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 Half of 2026 on attachment or at www.genmab.com/investor-relations CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 060826_CA34_Genmab Interim Report H1 2026