Rigel Pharmaceuticals, Inc. Q2 FY2025 earnings call

• Rigel had a strong quarter with net product sales of over $58 million, a 76% YOY growth, the best quarter ever. Total revenue was $101.7 million.
• Commercial portfolio performance: TAVALISSE had record sales due to new patient demand and carryover; GAVRETO saw 32% sequential revenue growth; REZLIDHIA had 36% YOY growth.
• Development pipeline: R289 Phase 1b study in lower-risk MDS completed dose escalation in July, expects updated data later; olutasidenib being evaluated in IDH1 mutated cancers via collaborations.
• Financial discipline: Generated $59.6 million net income and increased cash balance to over $108 million.

In the second quarter of 2025, Rigel Pharmaceuticals achieved net product sales of $58.9 million, a 76% year-over-year increase. The commercial portfolio includes three products: TAVALISSE generated $40.1 million (52% YOY growth), GAVRETO contributed $11.8 million, and REZLIDHIA had $7 million (36% YOY growth). Total revenue for the quarter was $101.7 million, including $42.7 million in contract revenues, with $40 million from the collaboration with Lilly being noncash revenue.

• Raised total revenue guidance for 2025 to $270 million to $280 million from $200 million to $210 million.
• Net product sales guidance revised to $210 million to $220 million from $185 million to $192 million.
• Anticipate positive net income for full year 2025 while funding clinical development programs.

Forward-looking statements are subject to risks and uncertainties, detailed in SEC filings such as the most recent annual report on Form 10-K and subsequent filings.

Q: Can you split the growth percentages for TAVALISSE's new patient demand and carryover?

A: Dave Santos mentioned higher new patient starts in the first half due to improved patient affordability from the Inflation Reduction Act.

Q: Was the growth in TAVALISSE surprising, and is there a risk of steady state?

A: Dave Santos stated they planned for TAVALISSE growth, and the elimination of the coverage gap in 2025 due to IRA helped, with no expectation of steady state yet.

Q: Discussion on CAGR and future trajectory?

A: Raul Rodriguez and Dave Santos noted the strong start to the year with confluence of factors driving growth, expecting continued growth with laser-focused targeting of new patients.

Q: On glioma and oluta development study design?

A: Lisa Rojkjaer said details on recurrent glioma study design would be disclosed later, and for CONNECT study, further discussion needed with CONNECT and agency on filing support.

Q: Impact of 3Q numbers and IRA on guidance?

A: Dave Santos mentioned they expect continued growth, with midpoint of guidance projecting double-digit growth, and IRA impact less significant in the second half.

Q: Clinically meaningful transfusion reduction in lower-risk MDS?

A: Lisa Rojkjaer noted approvals of luspatercept and imetelstat had 8-week transfusion independence rates around 38-40%, with room for improvement as current therapies have associated toxicities and administration issues.