Y-mAbs Therapeutics, Inc.

Y-mAbs reported Q1 2025 DANYELZA net product revenue of $20.9 million, versus $19.4 million in Q1 2024, an 8% increase. U.S. revenue was $13.4 million, down 28% year over year, while Ex-U.S. revenue was $7.5 million versus $0.8 million a year ago, an 816% increase. The company reported a net loss of $5.2 million, or $(0.12) per basic and diluted share, versus a net loss of $6.6 million, or $(0.15), in Q1 2024. R&D expense was $11.4 million, down from $13.3 million, and SG&A was $13.1 million, up from $11.4 million. Cash and cash equivalents were $60.3 million at March 31, 2025, and management said current operations support a runway into 2027. For Q2 2025, the company guided to total revenue of $17 million to $19 million. Management also reiterated full-year 2025 total revenue, operating expense, and cash investment guidance, and said it still expects to fund operations into 2027.

Mike Rossi framed the quarter as solid execution after the January business realignment into DANYELZA and Radiopharmaceuticals. He said the structure is intended to maximize DANYELZA while accelerating SADA PRIT development, and emphasized that the company is advancing both the GD2-SADA and CD38-SADA programs. His tone was confident but measured, stressing prudent spending, a strong cash position, and a May 28 radiopharmaceutical event that should provide more detail on data and pipeline plans.

Pete Pfreundschuh highlighted the financial mix: DANYELZA revenue of $20.9 million, R&D of $11.4 million, SG&A of $13.1 million, and a net loss of $5.2 million. He said the Ex-U.S. revenue increase was driven by the Western Asia named patient program launched in late 2024 plus growth in Eastern Asia and Latin America, while U.S. revenue was pressured by prior stocking patterns and slower starts. He also noted cash and cash equivalents of $60.3 million, down from $67.2 million at year-end 2024, representing $6.9 million of cash investment in Q1, and said the company is currently operating below its full-year cash investment guidance. He added that potential tariff increases should have a minimal impact and that Medicaid/340B gross-to-net adjustments appear to be stabilizing.

Analysts focused on the Q2 revenue guide, asking why it implies a sequential decline; management pointed to seasonality, the lack of prior-year stock-in orders, and the fact that some Q1-treated international patients will not recur in Q2. Questions on DANYELZA’s U.S. competition and switching dynamics were met with comments that the company is targeting larger, underpenetrated accounts and expects the NCCN guideline inclusion to help reopen clinical discussions. On the radiopharmaceutical side, management said CD38-SADA Part A is smaller than GD2-SADA, with roughly 12 to 15 patients planned, and that a bridging study will be needed before Part B after the new linker-chelator change. The team also said the new COG-based investigator-initiated DANYELZA study should start in Q2, likely within days rather than weeks, with most enrollment completed in 2025.