RIGEL PHARMACEUTICALS INC Q3 FY2024 earnings call

Commercial Portfolio Growth - Generated $38.9M net sales in Q3, up 44% y-o-y. Driven by GAVRETO's $7.1M in first full quarter with Rigel, TAVALISSE and REZLIDHIA achieving record quarters. - Expanded REZLIDHIA presence outside US with Kissei agreement, including $10M upfront. ### Pipeline Advancement - R289 dual IRAK1/4 inhibitor in Phase 1b study in lower risk-MDS, with initial safety/efficacy data in ASH abstract. - Olutasidenib collaborations progressing, including Phase 1b2 trial in IDH1 mutated AML with MD Anderson. - RIPK1 inhibitor programs advancing, with Phase 2a trial in rheumatoid arthritis and preclinical CNS penetrant program. ### Financial Discipline - Achieved positive third quarter and YTD net income, with cash, cash equivalents, and short-term investments at $61.1M as of quarter end.

In the third quarter, Rigel's total net sales were $38.9 million, up 44% from Q3 2023. TAVALISSE had net product sales of $26.3 million, an 8% increase y-o-y, with 2,797 bottles shipped, an 16% increase. REZLIDHIA had net product sales of $5.5 million, a 107% increase y-o-y, with 444 bottles shipped, more than doubling. GAVRETO had net product sales of $7.1 million in its first full quarter with Rigel, with 717 bottles shipped. Contract revenues from collaborations were $16.4 million, including $10 million upfront from Kissei for REZLIDHIA in Japan, Korea, and Taiwan, with potential for up to $152 million in milestone payments.

- Continue to execute on expanding commercial portfolio for topline growth. ### - Advance pipeline development, including internal plans for R289 in 2025. ### - Maintain financial discipline, aiming to reinvest in own development pipeline and remain self-sustaining.

- Risks associated with forward-looking statements, where actual results may differ from forecasts. ### - Uncertainties in clinical development and regulatory approvals for pipeline assets. ### - Potential challenges in transitioning products and maintaining distribution channel arrangements.

Q: Joe Pantginis asked about TAVALISSE's mix of refills and new prescriptions and GAVRETO's early traction.

A: Dave Santos said majority of TAVALISSE business is carryover from existing patients, with new patient starts contributing to growth. For GAVRETO, majority of business is through specialty pharmacies, with some direct accounts yet to place orders.

Q: Ashiq asked about GAVRETO's stocking benefit and growth trajectory.

A: Dave Santos and Dean Schorno explained that Q3 had true patient demand with some inventory build in channels, expecting continued demand growth.

Q: Kalpit Patel asked about R289's Grade 3/4 adverse events and data at ASH.

A: Lisa Rojkjaer said detailed data would be shared at ASH in December, with updated data from October 25 cutoff.

Q: Farzin Haque asked about R289's success bar and GAVRETO's infection risk.

A: Lisa Rojkjaer discussed R289's potential in lower-risk MDS with preliminary positive data, and Dave Santos noted oncologists are familiar with managing infections in GAVRETO's patient population.

Q: Kalpit Patel asked about R289's differentiation vs other IRAK inhibitors.

A: Raul Rodriguez and Lisa Rojkjaer noted R289 is a dual IRAK1/4 inhibitor, unlike others that are IRAK4 inhibitors, providing more profound cytokine inhibition.