Financial Data and Key Metrics Changes - Total revenue for the full year 2024 was USD 87.7 million, within the guidance range of USD 87 million to USD 95 million [11] - DANYELZA net product revenues for the full year 2024 were USD 85.2 million, with a fourth quarter revenue of USD 24.5 million, representing a 5% increase compared to the same period in 2023 [22][41] - The company ended 2024 with cash and cash equivalents of USD 67.2 million, a decrease of USD 11.4 million from the previous year [47] - The net loss for the fourth quarter 2024 was USD 6.8 million, compared to a net loss of USD 1 million in the same quarter of 2023 [46] Business Line Data and Key Metrics Changes - DANYELZA maintained a steady market share of 15% to 17% in the U.S. anti-GD2 market [11][23] - International DANYELZA net product revenues in Q4 2024 were USD 7.7 million, a 78% increase compared to Q4 2023, driven by the launch of a named patient program in Western Asia [26][42] - The company recorded USD 2 million in licensing revenue for Q4 2024, compared to no licensing revenue in Q4 2023 [43] Market Data and Key Metrics Changes - DANYELZA's estimated total share of the U.S. anti-GD2 market remained steady, with 69 accounts ordering the product as of December 31, 2024 [23] - The company faced competition from new market entrants and ongoing clinical trials, impacting U.S. revenues [22][41] Company Strategy and Development Direction - The company announced a strategic realignment into two distinct business units: DANYELZA and Radiopharmaceuticals, aimed at accelerating the development of the SADA PRIT platform [14][16] - The focus is on expanding radiopharmaceutical capabilities and improving capital efficiencies while maximizing DANYELZA's potential [15][16] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from competition but expressed confidence in DANYELZA's growth potential and the strength of its international markets [12][22] - The company anticipates total net revenue for 2025 to be between USD 75 million and USD 90 million, with a first quarter guidance of USD 18 million to USD 21 million [48][49] Other Important Information - Research and development expenses decreased to USD 49 million for the year ended December 31, 2024, from USD 54.2 million in 2023 [44] - Selling and general administrative expenses increased to USD 54.6 million for the year ended December 31, 2024, primarily due to legal settlements and personnel costs [45] Q&A Session Summary Question: Should we expect a flat trajectory for DANYELZA revenue in 2025? - Management indicated plans to accelerate growth, with some ramp-up expected as they support clinical trials and seek additional market penetration [54][55] Question: What tissues will be important for dose selection in the upcoming SADA update? - Key areas include the kidney, liver, and bone marrow, with a focus on potential dose-limiting toxicities [62][63] Question: Can you provide a breakdown of the 2025 OpEx guidance? - The OpEx guidance of USD 116 million to USD 121 million excludes cost of goods, with SG&A costs expected to grow slightly from the previous year [68][72] Question: How will investigator-sponsored studies impact DANYELZA revenue? - Continued investment in investigator-sponsored trials is expected to increase market penetration and support additional indications [76][78] Question: What are the market dynamics in neuroblastoma with the introduction of DFMO? - DFMO may provide temporary solutions, but patients will likely return to anti-GD2 therapies as their condition progresses [112][113] Question: What drives fluctuations in cost of goods sold? - Variations in batch costs and inventory write-offs contribute to fluctuations in COGS [116][117]