Rigel(US:RIGL)2021-11-03 00:59Financial Data and Key Metrics Changes - The company reported net product sales of TAVALISSE at $16 million for Q3 2021, a 2% decrease compared to Q3 2020 [51] - Gross product sales were $20.5 million, with 1,657 bottles shipped to specialty distributors [51] - The gross to net adjustment was approximately 22.1% of gross product sales [51] Business Line Data and Key Metrics Changes - Demand for TAVALISSE grew by 5% year-over-year, with over 1,700 total bottles shipped [17] - New patient starts for TAVALISSE were the strongest since 2019, indicating potential for future growth [11] - Despite the growth in demand, total bottle volume decreased by 4% due to inventory impacts [19] Market Data and Key Metrics Changes - The company expanded its hem-onc commercial organization by adding 16 new sales representatives [10] - Internationally, TAVALISSE was launched in France, Italy, and Spain, with plans for further rollout across Europe [25] Company Strategy and Development Direction - The company aims to leverage its experience in ITP to capitalize on the potential first-mover advantage in warm autoimmune hemolytic anemia [27] - Plans to initiate a Phase 1b/2 study with IRAK1/4 molecule R289 in low-risk MDS and a Phase 2 study with RIP1 inhibitor in autoimmune indications [62] - The company is preparing for pivotal data from its Phase 3 trial in warm AIHA expected in mid-2022 [60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about regaining a good trajectory in growing ITP sales as access to physicians improves [60] - The company anticipates that 2022 will be a transformative year with significant clinical milestones [62] - Management highlighted the ongoing need for effective treatment options for hospitalized COVID-19 patients [39] Other Important Information - The company ended the quarter with cash, cash equivalents, and short-term investments of $143.1 million [57] - Total costs and expenses increased to $41.3 million in Q3 2021, primarily due to R&D costs related to the COVID-19 trial [56] Q&A Session Summary Question: Can you talk about the bar you need to meet on the primary endpoint of durable hemoglobin response rate compared to placebo for the Phase 3 trial to be positive? - The primary endpoint criteria were modeled based on Phase 2 data, indicating a high bar for statistical significance [66] Question: Why did the growth in bottles shipped to patients and clinics seem lighter than prior expectations? - The company noted that new patient starts were among the highest levels since the pandemic began, contributing to a positive outlook despite inventory fluctuations [70][72] Question: Have the inventory levels normalized after the first three quarters? - The company indicated that inventory levels are dynamic and will adjust based on demand growth, expecting higher bottles shipped in Q4 [76][78] Question: What promotional efforts will the new sales force undertake? - The new sales force will focus on increasing interactions with prescribers and promoting the efficacy of TAVALISSE [80] Question: Is there any off-label use of TAVALISSE in COVID-19? - There has been limited off-label use of TAVALISSE in COVID-19 due to lack of approval or EUA [98] Question: Why did enrollment take so long for Phase 3 for warm AIHA? - Enrollment was affected by the pandemic, which slowed down patient recruitment due to safety concerns [100][101]