Nuvation Bio Inc. Q3 FY2025 earnings call

• David Hung: Highlighted IBTROZI's full FDA approval on June 11, 2025, with 204 new patients starting IBTROZI in Q3 (over 15 new patient starts per week). Discussed durable efficacy, robust intracranial activity, and excellent tolerability of IBTROZI. Mentioned TRUST-I and TRUST-II studies showing a 50-month median duration of response in TKI-naive patients. Also talked about safusidenib's potential in IDH1-mutant glioma, ongoing studies, and FDA interactions.
• Colleen Sjogren: Shared IBTROZI launch momentum with 204 new patients in Q3, focus on deepening adoption in the U.S. and raising awareness of oncogenic driver testing. Discussed usage across academic/community settings, TKI-naive and pretreated patients.
• Philippe Sauvage: Reported $13.1 million total revenue in Q3, with $7.7 million from IBTROZI. R&D expenses $28.8 million, SG&A $37.4 million. Cash balance $549 million, term loan $50 million available. Discussed collaboration with Nippon Kayaku and potential European partnerships for IBTROZI.

The main product segment is IBTROZI. In the third quarter, IBTROZI generated $7.7 million in net product revenue. There is no significant revenue contribution percentage provided for IBTROZI specifically as it's the lead product in the commercial stage. The safusidenib segment is in the pipeline with ongoing clinical studies and no reported revenue yet.

No net revenue guidance provided yet. Annualized net revenue from Q3 new patients in IBTROZI is over $55 million if patients remain on therapy for 12 months. Anticipates submitting a supplemental NDA (sNDA) for IBTROZI by the end of the week. Believes there is a larger commercial opportunity ahead with IBTROZI's 50-month median duration of response.

• Clinical trial timelines for safusidenib studies are long, with the high-grade glioma study expected to be completed in 2029. - Regulatory approvals for safusidenib face challenges, such as demonstrating PFS benefit in randomized studies. - Payer mix and reimbursement challenges affecting gross to net margins. - Competition from other ROS1 TKIs and potential future competitors in the market.

Q: Could you provide guidance on sales for this year?

A: We are not going to provide any guidance on our numbers, but we are very comfortable with the level of consensus today.

Q: How do you see the current and future trends in usage between treatment-naive or first-line and second-line settings relative to your expectations?

A: We're seeing an uptake in all lines of patients. Over time, as we get turnover of patients, we anticipate the proportion of first-line patients to grow.

Q: Can you tell us how many patients were on the expanded access program?

A: Only 6 patients were on the expanded access program, and we expect growth as more patients are treated.

Q: What is the timeline for submitting the supplemental NDA to update the label for IBTROZI?

A: We anticipate submitting that by the end of the week.

Q: Could you give guidance on new patients per week and growth trends?

A: We expect continuous growth as there are new cancer patients every day and IBTROZI is the best drug for ROS1 positive lung cancer. Growth will come from organic penetration and increased testing awareness.

Q: What is the consensus for next year's revenue?

A: We think consensus for 2026 is about $115 million.

Q: How are you preparing for competitors coming to the market?

A: We feel extremely confident as our metrics are unmatched, and our sales force is built up with no plans for increase.