Radiopharmaceutical R&D Update May 28, 2025 Mike Rossi President and Chief Executive Officer Natalie Tucker SVP, Radiopharmaceutical Business Unit Head Norman LaFrance, MD Chief Medical and Development Officer Additional Team Members Available During Q&A Disclaimer Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. The forward-looking statements involve substantial risks and uncertainties. All statem ...

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]