Release Date: May 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Y-mAbs Therapeutics Inc (YMAB, Financial) reported DANYELZA net product revenues of $20.9 million for Q1 2025, representing an 8% increase from the same period last year.
- The company successfully completed Part A of the GD2-SADA Phase 1 clinical trial and dosed the first patient in the CD38 SADA Phase 1 clinical trial.
- Y-mAbs Therapeutics Inc (YMAB) has a strong financial position with $60.3 million in cash, providing an anticipated runway into 2027.
- DANYELZA has been added to the NCCN guidelines for the treatment of relapsed or refractory neuroblastoma, which is expected to boost its market presence.
- The company is actively expanding its market reach with new partnerships and investigator-sponsored trials, particularly in high-volume centers and new indications.
Negative Points
- US DANYELZA net product revenues decreased by 28% compared to the prior year period, due to competitive pressures and changes in ordering patterns.
- The company did not record any licensing revenue for Q1 2025, compared to $0.5 million in the same period last year.
- Research and development expenses decreased by $1.9 million, indicating potential scaling back in certain areas.
- Selling and general administrative expenses increased by $1.7 million, partly due to personnel costs and business realignment charges.
- The company reported a net loss of $5.2 million for Q1 2025, although this was an improvement from the previous year's loss.
Q & A Highlights
Q: Can you help us understand the US and ex-US revenue dynamics for DANYELZA and what factors could lead to higher revenue?
A: Doug Gentilcore, Senior Vice President, Head of DANYELZA Business Unit, explained that ex-US markets are seeing steady growth, particularly in Asia and the Middle East, despite not having the stocking orders seen in previous quarters. In the US, there was a slow start to the quarter, but an uptick in enrollments was observed towards the end of Q1 and into Q2. Michael Rossi, CEO, added that they expect the revenue split to continue following the 80-20 or 70-30 rule between US and ex-US markets.
Q: How do you see the competitive dynamics in the US affecting DANYELZA, and what are the switching dynamics with competitors?
A: Michael Rossi, CEO, stated that they are focusing on expanding within current accounts and targeting large accounts that have not yet used DANYELZA. Clinical trials are expected to increase experience within new accounts, providing a tailwind for capturing market share.
Q: Your Q2 revenue guidance suggests a downtrend compared to Q1. Can you elaborate on the factors influencing this?
A: Michael Rossi, CEO, noted that there is seasonality in the product, and the strong start in ex-US markets in Q1 is not expected to repeat in Q2. Peter Pfreundschuh, CFO, added that the absence of stocking orders in Q2, which were present in Q2 2024, contributes to the guidance range of $17 million to $19 million. They aim to provide realistic guidance and remain confident in their full-year revenue target.
Q: What are the current plans for naxitamab in osteosarcoma?
A: Michael Rossi, CEO, mentioned that they continue to support investigator-initiated studies in osteosarcoma and are working on developing a better diagnostic for GD2 expression. Insights from their GD2-SADA trial will help accelerate development with better patient selection.
Q: Can you provide details on the CD38 SADA trial, including patient enrollment and timeline expectations?
A: Michael Rossi, CEO, stated that the CD38 SADA trial is a smaller study than the GD2 trial, focusing on relapsed/refractory non-Hodgkin's lymphoma. It aims to enroll 12 to 15 patients and is primarily a platform safety study. They plan to accelerate the study, with a deeper dive into the Radiopharmaceutical platform scheduled for May 28.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
