Rigel Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Corporate strategy focuses on growing hematology and oncology business via commercial performance, pipeline expansion, and financial discipline.
• Reported strong third quarter with total revenue $69.5M, record net product sales $64.1M.
• Development pipeline: Ongoing Phase Ib study of R289 with enrollment in dose escalation phase completed, dose expansion phase started; olutasidenib has 4 posters at ASH meeting, 5th study with MD Anderson opened, first patient enrolled in CONNECT Phase II TarGeT-D study.
• Financial discipline led to $27.9M net income and cash balance $137.1M.
• Raised 2025 revenue guidance to $285M - $290M, net product sales to $225M - $230M.
• Commercial team focused on executing strategy, expanding access to products outside US for TAVALISSE and REZLIDHIA.

Total revenue for the third quarter was $69.5 million, including record net product sales of $64.1 million, a 65% year-over-year increase. Net product sales by product: TAVALISSE had $44.7 million, a 70% year-over-year increase; GAVRETO had $11.1 million, a 56% year-over-year increase; REZLIDHIA had $8.3 million, a 50% year-over-year increase. Revenue contribution: TAVALISSE was the cornerstone, GAVRETO became a stable business over $11M per quarter, REZLIDHIA saw increased demand with more prescribers.

• Raised 2025 total revenue guidance to $285 million to $290 million from prior $270 million to $280 million.
• New net product sales guidance is $225 million to $230 million.
• Anticipate positive net income for full year 2025 while funding clinical development opportunities.
• Enrollment in dose escalation phase of R289 Phase Ib study complete, dose expansion ongoing; olutasidenib collaborations advancing with ongoing enrollments.

Q: How see competitive positioning of R289 in lower-risk MDS versus RYTELO and plans for registrational study?

A: Lisa Rojkjaer says too early to speculate, but R289 in different patient population than imetelstat, will get through dose expansion, fix dose then look at less heavily pretreated patients. Raul adds there's broad opportunities for R289 in lower-risk MDS after ESAs.

Q: Views on priority review for R289 and parameters for data needed?

A: Lisa Rojkjaer says Fast Track designation opens potential for priority review, need to see data evolve in dose expansion part of study.

Q: Benchmarks for oluta in CONNECT study in glioma?

A: Lisa Rojkjaer says it's novel maintenance approach, comparison vs historical control, no specific data in this maintenance setting.

Q: Improvements in Q3 gross to net, rate by brand and expected Q1 and Q4 rates?

A: Raul says haven't provided specific by product, factors include mix, patient/payer, legislation like IRA, Dave adds made strides in patient services and distribution network to improve gross to net.

Q: Expectations for updated data at ASH for R289 in lower-risk MDS patients?

A: Lisa Rojkjaer says with October 28 data cutoff, 16 weeks of follow-up on 500-milligram BID dose level patients.