
Financial Data and Key Metrics Changes - The company reported net sales of TAVALISSE at $22.3 million for Q1 2023, representing a 38% year-over-year increase compared to the same quarter last year [31][41] - REZLIDHIA generated net sales of $1.5 million in Q1 2023, with total product sales since launch reaching $2.3 million [15][42] - Total cost and expenses decreased to $38.8 million from $43 million in the same period for 2022, primarily due to reduced research and development costs [46] Business Line Data and Key Metrics Changes - TAVALISSE achieved a record shipment of 2,256 bottles in Q1 2023, marking a 23% growth over Q1 2022 [29] - REZLIDHIA shipped 109 bottles to patients in clinics during Q1, with a total of 111 bottles shipped since its launch [13][41] - The company shipped 113 bottles of REZLIDHIA to its distribution network, resulting in gross product sales of $1.8 million [41] Market Data and Key Metrics Changes - The American Cancer Society estimates over 20,000 patients will be diagnosed with AML in 2023, with 6% to 9% having the IDH1 mutation, representing a near-term opportunity for REZLIDHIA [11][12] - Approximately 90% of Medicare lives have confirmed published coverage for REZLIDHIA, indicating strong market access [22] Company Strategy and Development Direction - The company is focused on expanding its hematology-oncology business through internal development programs and in-licensing opportunities [8][35] - The launch of REZLIDHIA is being supported by a specialized institutional team targeting key leukemia treaters and academic accounts [76] - The company aims to continue growing TAVALISSE sales while executing the launch of REZLIDHIA [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong start to 2023, highlighting the continued momentum for TAVALISSE and the successful launch of REZLIDHIA [5][49] - The company is optimistic about achieving cash flow breakeven and is focused on revenue growth [57][58] Other Important Information - The company ended the quarter with cash, cash equivalents, and short-term investments of $58.7 million, having accessed an additional $20 million term loan [48] - The gross to net adjustment for TAVALISSE and REZLIDHIA was approximately 29% and 20% of gross product sales, respectively [42][44] Q&A Session Summary Question: Changes in partnered program with Eli Lilly regarding RIPK1 inhibitor - Management clarified that Eli Lilly has always been interested in multiple indications for the RIPK1 inhibitor, with a current focus on rheumatoid arthritis due to market opportunities [52][53] Question: Future cash burn expectations - The company ended Q1 with $58.7 million in cash and is focused on achieving cash flow breakeven, with a path towards that goal [56][58] Question: Progress on REZLIDHIA prescriber base and expectations - Management reported approximately 29 prescribers for REZLIDHIA and expressed optimism about increasing prescriber breadth as awareness grows [71][73] Question: Key factors for sustaining momentum in TAVALISSE - Management highlighted the importance of ongoing awareness efforts among clinicians and the potential for continued growth as patients fail other therapies [80][81]