Y-mAbs(YMAB) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company recorded total Danielza net product revenues of $20.9 million in Q1 2025, representing an 8% increase from $19.4 million in Q1 2024 [20][24] - The net loss for Q1 2025 was $5.2 million, or a negative $0.12 per share, compared to a net loss of $6.6 million, or a negative $0.15 per share in Q1 2024 [23][24] - Cash and cash equivalents at the end of Q1 2025 were $60.3 million, down from $67.2 million at the end of 2024, indicating an investment of $6.9 million in Q1 2025 [24][26] Business Line Data and Key Metrics Changes - Danielza's net product revenues in the U.S. for Q1 2025 were $13.4 million, down 28% from the prior year, while ex-U.S. revenues were $7.5 million, an increase of $6.7 million, driven by the named patient program in Western Asia [15][20] - The Danielza business unit achieved a segment profit from operations of $8.8 million, reflecting a 42% segment profit margin based on total revenues [24] - The radiopharmaceuticals business unit reported a segment loss from operations of $6.1 million for Q1 2025, compared to a loss of $6.0 million in Q1 2024 [24] Market Data and Key Metrics Changes - The company noted a slowdown in new patient enrollment in the U.S. due to competitive pressures and market dynamics, impacting revenue [16][18] - The addition of Danielza to the NCCN guidelines for treating relapsed or refractory neuroblastoma is expected to enhance its market position and drive future growth [18][100] Company Strategy and Development Direction - The company has established two distinct internal business units, Danielza and Radiopharmaceuticals, to maximize potential and accelerate development [6][24] - The focus is on enhancing advocacy, increasing new patient starts, and expanding into high-volume commercial accounts to improve Danielza's market share [12][71] - Upcoming updates on the radiopharmaceutical R&D event are scheduled for May 28, which will include data from clinical trials and pipeline updates [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations into 2027, despite current challenges [7][25] - The anticipated revenue guidance for Q2 2025 is between $17 million and $19 million, reflecting seasonal trends and historical performance [25][40] - Management remains optimistic about the potential for growth in the U.S. market, particularly with the recent inclusion of Danielza in treatment guidelines [100][102] Other Important Information - The company is monitoring potential tariff impacts on its supply chain, with expectations of minimal effects [26] - Research and development expenses decreased to $11.4 million in Q1 2025 from $13.3 million in Q1 2024, reflecting prudent spending [22][23] Q&A Session Summary Question: Understanding U.S. and ex-U.S. revenue dynamics for Danielza - Management noted steady growth outside the U.S. and a slower start in the U.S. due to competitive pressures, but an uptick in enrollments is expected [30][32] Question: Q2 revenue guidance and historical trends - Management explained that seasonality and previous stock ins influenced the guidance, projecting slight growth in U.S. sales [38][40] Question: Plans for naxitamab in osteosarcoma - The company continues to support research in osteosarcoma and aims to improve diagnostics for GD2 expression [46][47] Question: Details on CD38 SADA trial - The first patient has been dosed, with plans to enroll 12 to 15 patients in a safety study [50][52] Question: Medicaid reserve perspective - Management indicated stabilization in Medicaid gross to net elements, with no major adjustments anticipated for 2025 [55][58] Question: Impact of new construct for GD2 SADA on study timelines - A bridging study will be conducted to assess safety before moving forward with Part B of the study [61][62] Question: Long-term growth for Danielza - The focus is on advocacy development, financial messaging, and global expansion to drive long-term growth [71][72] Question: NCCN guidelines impact on Danielza growth - Inclusion in the guidelines is expected to remove a headwind and provide potential tailwinds for market discussions [99][100]