- Rigel Pharmaceuticals Inc (RIGL, Financial) reported total revenue of $69.5 million for the third quarter of 2025, including record net product sales of $64.1 million, a 65% year-over-year increase.
- The company has raised its 2025 revenue guidance to $285 million to $290 million, reflecting anticipated growth of 55% to 59% compared to 2024.
- Rigel Pharmaceuticals Inc (RIGL) has completed enrollment in the dose escalation phase of its Phase 1B study of R289, with promising preliminary safety and efficacy data.
- The company is expanding access to its products internationally, with TAVALISSE now available in Japan, Europe, Canada, Israel, and South Korea.
- Rigel Pharmaceuticals Inc (RIGL) reported a net income of $27.9 million for the third quarter, significantly higher than the $12.4 million reported in the same period of 2024.
Negative Points
- The CNS disease program with Eli Lilly will be terminated, which may impact future collaboration opportunities in that area.
- There is uncertainty regarding the competitive positioning of R289 in lower-risk MDS, as it is still early to determine its potential against competitors like RYTELO.
- The company faces challenges in expanding its product portfolio through in-licensing and acquisitions, which are necessary for long-term growth.
- Rigel Pharmaceuticals Inc (RIGL) has not provided specific guidance on gross-to-net rates by product, which may lead to uncertainty in financial projections.
- The company is still evaluating options for a Rigel-led study in glioma, indicating potential delays in advancing this part of the development pipeline.
Q & A Highlights
Q: How do you see the competitive positioning of R289 in lower-risk MDS versus RYTELO, and would you consider a similar placebo-controlled study for a potential registrational study?
A: Lisa Rojkjaer, Executive Vice President, Chief Medical Officer, mentioned that it might be too early to speculate on this. The patient population for R289 is different from RYTELO's, as they are more heavily pretreated. The plan is to complete the dose expansion phase and then evaluate the activity in less heavily pretreated patients before deciding on the next steps. Raul Rodriguez, President and CEO, added that there is a broad range of opportunities for R289 in lower-risk MDS, both before and after Luspatercept.
Q: What level of data do you feel might be needed for priority review of R289, especially regarding reducing transfusions?
A: Lisa Rojkjaer explained that the fast track designation opens up potential for priority review. The data from the dose expansion part of the study will be crucial in determining the next steps.
Q: Can you provide benchmarks for the CONNECT study in glioma with IDH1 mutations?
A: Lisa Rojkjaer stated that this is a novel approach, focusing on maintenance therapy post-chemo radiation. The comparison will be against historical controls, as there is no specific data for this maintenance setting.
Q: What improvements in Q3 gross-to-net rates were observed, and what are the expectations for Q1 and Q4, especially under the Medicaid Part D redesign?
A: Dean Schorno, Chief Financial Officer, noted that favorable gross-to-net dynamics have been observed, driven by patient affordability and various factors like patient mix and legislation. Specific product-by-product guidance was not provided. David Santos, Chief Commercial Officer, added that improvements in patient services and distribution efficiency have also contributed to better gross-to-net outcomes.
Q: How are you setting expectations for the updated data at ASH for R289 in lower-risk MDS patients?
A: Lisa Rojkjaer mentioned that with the October 28 data cut-off, they will have 16 weeks of follow-up on all patients, including those in the 500-mg BID dose level. Raul Rodriguez added that they are eager to share this data set.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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