Core Insights - Genmab A/S published its Annual Report for 2025, highlighting significant business progress, financial performance, and outlook for 2026 [1] Business Progress - Epcoritamab (EPKINLY®) received FDA approval for earlier lines of therapy in follicular lymphoma, based on successful Phase 3 EPCORE® FL-1 trial results [6] - Acquisition of Merus N.V. adds a late-stage breakthrough therapy asset, petosemtamab, enhancing growth opportunities [6] - Tivdak® was approved in Europe and Japan for recurrent or metastatic cervical cancer, marking Genmab's first independent product launch [6] - Rina-S® expanded its Phase 3 development into endometrial cancer and platinum-sensitive ovarian cancer, receiving Breakthrough Therapy Designation from the FDA [6] - Continued development of organizational infrastructure with over 300 new hires [6] Financial Performance - Net sales of DARZALEX® reached $14,351 million in 2025, a 23% increase from $11,670 million in 2024 [6] - Global net sales of EPKINLY/TEPKINLY were $468 million in 2025, up 67% from $281 million in 2024, driven by growth in diffuse large B-cell lymphoma and follicular lymphoma [6] - Genmab's total revenue for 2025 was $3,720 million, a 19% increase from $3,121 million in 2024, primarily due to higher royalties from DARZALEX and Kesimpta [6] 2026 Outlook - Genmab projects 2026 revenue between $4,065 million and $4,395 million, with a midpoint guidance of $4,230 million [7] - Expected royalty revenue for 2026 is projected to be between $3,440 million and $3,685 million, with a midpoint of $3,563 million [7] - Anticipated operating expenses for 2026 are expected to range from $2,710 million to $2,910 million, reflecting investments in late-stage programs [13] - Projected operating profit for 2026 is estimated to be between $900 million and $1,400 million [14]

Financial Performance - Total revenue grew by 21% to USD 2,662 million for the first nine months of 2025 [43] - Operating profit increased by 52% to USD 1,007 million for the first nine months of 2025 [12, 43] - Recurring revenue grew by 26% for the first nine months of 2025 [43] - Combined commercialized medicines sales increased by 54% to USD 453 million for the first nine months of 2025 [28] Product Performance - EPKINLY net sales reached USD 333 million, a 64% increase year-over-year for the first nine months of 2025 [31] - TIVDAK net sales reached USD 120 million, a 30% increase year-over-year for the first nine months of 2025 [36] Strategic Initiatives - The company is planning to acquire Merus to deliver the next decade of sustainable growth [12, 14] - The company anticipates a first launch for petosemtamab in 2027 [17] Rina-S® Data - Rina-S® 100mg/m2 led to a confirmed ORR of 50% and a DCR of 100% in patients with advanced or recurrent endometrial cancer [26]

Financial Performance - Total revenue increased by 19% from USD 1382 million to USD 1640 million[39] - Operating profit increased by 56% from USD 352 million to USD 548 million[39] - Recurring revenue grew by 27%[38] - Combined commercialized medicines sales increased by 60% from USD 181 million to USD 289 million[23] - Cash reserves stand at USD 29 billion[12] Product Performance - EPKINLY net sales increased by 74% to USD 211 million[27] - TIVDAK net sales increased by 30% to USD 78 million[32] - Rina-S® showed a confirmed ORR of 500% in endometrial cancer patients[17] Pipeline Development - EPCORE® FL-1 clinical trial met dual primary endpoints of ORR and PFS, reducing the risk of disease progression or death by 79%[14] - sBLA for EPKINLY® in 2L FL accepted with a PDUFA date of November 30, 2025[13] Guidance - Revenue guidance improved to USD 3500-3700 million, representing a 15% year-over-year growth[41] - Operating profit guidance improved to USD 1055-1405 million, representing a 26% year-over-year growth[41]

Core Insights - Johnson & Johnson announced significant findings from two Phase 3 studies demonstrating that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based regimens lead to deep and sustained minimal residual disease (MRD) negativity and improved long-term progression-free survival (PFS) in newly diagnosed multiple myeloma patients, regardless of transplant eligibility [1][2][3] Group 1: Study Findings - In the Phase 3 PERSEUS study, over half of the patients maintained MRD negativity for 24 months or longer with the DARZALEX FASPRO® regimen [1][2] - The addition of DARZALEX FASPRO® to the standard treatment regimen (bortezomib, lenalidomide, and dexamethasone) resulted in a 55.8% sustained MRD negativity rate at the 10⁻⁵ threshold compared to 22.6% with the standard regimen alone [2][4] - The Phase 3 CEPHEUS study showed a 60% overall MRD negativity rate at the 10⁻⁵ threshold in transplant-ineligible patients, indicating significant treatment benefits across different patient populations [1][3] Group 2: Long-term Outcomes - At a median follow-up of 47.5 months, the PFS rate was 95.3% at 48 months for patients receiving the DARZALEX FASPRO® regimen, highlighting its effectiveness in delaying disease progression [2] - The study results indicated that 69% of patients treated with the DARZALEX FASPRO® regimen remained progression-free at 54 months, compared to 48% with the standard regimen [4][5] - The overall survival (OS) favored the DARZALEX FASPRO® group, with a hazard ratio of 0.66, suggesting a potential survival benefit [4] Group 3: Safety and Efficacy - The safety profiles of DARZALEX FASPRO® in the PERSEUS and CEPHEUS studies were consistent with previously known safety data, indicating a manageable safety profile [5] - The studies included diverse patient populations, including those considered high-risk for cytogenetic abnormalities, reinforcing the broad applicability of DARZALEX FASPRO® in treating multiple myeloma [3][5] - The consistent results across different studies support the role of DARZALEX FASPRO® as a cornerstone of frontline therapy for multiple myeloma [5]