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]