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Genmab(GMAB) - 2025 Q3 - Earnings Call Presentation
2025-11-06 17:00
Quarter End Results As part of Genmab's First Nine Months 2025 Financial Results presentation, we will discuss several products developed in collaboration with strategic partners or that are the result of product or technology licenses with other companies. This slide is an acknowledgement of those relationships. Period Ended September 30, 2025 © Genmab 2025 Forward looking statement This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and s ...
Genmab(GMAB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 16:00
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]
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity
Prnewswire· 2025-06-03 14:45
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]