Rigel(US:RIGL)2022-11-03 23:25Financial Data and Key Metrics Changes - The company reported total revenue of $22.4 million for Q3 2022, which includes net product sales from TAVALISSE of $19.2 million, reflecting a 20% increase compared to the same quarter last year [55][53] - The gross to net adjustment for TAVALISSE was approximately 28.9% for Q3 2022, with expectations for a 30% adjustment in Q4 2022 [53][54] - The company ended the quarter with cash, cash equivalents, and short-term investments of $81.6 million [57] Business Line Data and Key Metrics Changes - TAVALISSE achieved the highest quarterly net product sales since its launch, with 2,026 bottles shipped, representing nearly 19% growth year-over-year [40][41] - The company is excited about the potential of olutasidenib, which is nearing approval with a PDUFA date set for February 15, 2023 [9][60] - The Phase 2 registrational study of olutasidenib showed a 35% composite endpoint achievement, with over 90% of responders achieving complete remission [22][28] Market Data and Key Metrics Changes - The company noted that the market for AML treatments is significant, with over 20,000 new diagnoses expected in 2022 [14] - The company is focusing on the IDH1 mutation, which is present in 6% to 9% of AML patients, indicating a well-defined patient population for olutasidenib [16][32] Company Strategy and Development Direction - The company aims to expand its hematology-oncology portfolio with olutasidenib and is preparing for its launch [9][38] - The company is also exploring partnerships to create value, including collaborations for fostamatinib in COVID-19 and the RIP1 inhibitor program with Eli Lilly [12][50] - The company is committed to increasing awareness of TAVALISSE among prescribing clinicians to drive new patient starts [41][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of olutasidenib and its potential to positively impact the lives of patients with relapsed refractory IDH1 positive AML [35][60] - The company anticipates a significant decrease in operating expenses in 2023 due to completed Phase 3 studies and workforce reductions [57][92] - Management highlighted the importance of the upcoming ASH conference for increasing awareness of Rigel's hem-onc pipeline [42] Other Important Information - The company is exploring options for fostamatinib in COVID-19 but does not plan to commercialize it independently [12] - The company is preparing for a Phase 2 study of the RIP1 inhibitor R552 in collaboration with Eli Lilly, expected to start in the first half of 2023 [50] Q&A Session Summary Question: What drives the better durability seen with olutasidenib compared to TIBSOVO? - Management acknowledged the significant increase in duration of CR + CRh response and noted that better initial responses may contribute to longer-term outcomes [65][66][70] Question: What were the headwinds for TAVALISSE in Q3? - Management indicated that while there was flat growth compared to Q2, year-over-year growth was strong, driven by new patient starts [72][74] Question: What is the expected milestone payment from Kissei for TAVALISSE in Japan? - Management expects a $20 million milestone payment upon approval, likely in Q1 of next year [86][88] Question: What is the current size of the sales force and any potential changes? - The sales force remains at 54 territories, with no changes anticipated due to the focus on higher-tier targets [99][101] Question: Are there any concerns regarding QTC prolongation with olutasidenib? - Management confirmed no evidence of QTC prolongation with olutasidenib and noted that differentiation syndrome was managed effectively [105][106]