Intra-Cellular Therapies(US:ITCI)2021-02-25 19:47Financial Data and Key Metrics Changes - In Q4 2020, net product revenues of CAPLYTA were $12.4 million, up from $7.4 million in Q3 2020, with total revenues for the year at $22.8 million [36][37] - Research and development expenses decreased to $14.3 million in Q4 2020 from $19.1 million in Q4 2019, while selling, general and administrative expenses increased to $58.3 million from $22.8 million in the same period [36][38] - The net loss for Q4 2020 was $60.7 million, compared to a net loss of $40.6 million in Q4 2019, with a total net loss for the year of $227 million or $3.23 per share [39] Business Line Data and Key Metrics Changes - CAPLYTA experienced a 77% growth in prescriptions in Q4 2020 compared to Q3 2020, indicating strong market performance despite COVID-19 challenges [16][30] - The company is pursuing label expansion for CAPLYTA to include indications for bipolar depression, with a supplemental new drug application submitted [11][19] Market Data and Key Metrics Changes - CAPLYTA's market access position is strong, with coverage exceeding 95% of covered lives in Medicare Part D and state Medicaid, representing a significant portion of schizophrenia prescriptions [28] - The overall antipsychotic market remained flat due to COVID-19, yet CAPLYTA's prescription growth continued, suggesting resilience in its market performance [30] Company Strategy and Development Direction - The company aims to expand its CAPLYTA label for bipolar depression and continue late-stage development programs for Lumateperone in depressive disorders [11][20] - The company is also advancing its Long Acting Injectable formulation of Lumateperone and exploring new programs such as ITI-1284 for elderly patients [22][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of CAPLYTA and anticipates a strong build in revenues throughout 2021, particularly in the second half as COVID-19 disruptions improve [71] - The company highlighted the significant unmet medical need in neuropsychiatric conditions and the potential of Lumateperone to address these needs [15][94] Other Important Information - The company ended 2020 with approximately $659 million in cash, cash equivalents, and investments, providing a strong financial position for future growth [26][39] - The company is preparing for potential label expansion in bipolar depression and is optimistic about the reception of its products in the market [34][62] Q&A Session Summary Question: Could you give us some color on the data package for the bipolar depression sNDA? - Management confirmed that updated information on UGT interaction was submitted and no interactions were observed, which is positive news [43][44] Question: What are your goals for new prescribers versus deepening existing prescriber use? - The company aims to extend both the breadth of prescribers and deepen existing prescriber use of CAPLYTA, supported by positive feedback from patients and physicians [50] Question: How comfortable are you with consensus numbers for 2021 revenue? - Management expressed comfort with consensus numbers around $110 million, anticipating strong revenue growth as COVID disruptions improve [71] Question: What is the expected timeline for the MDD program? - The company expects to initiate clinical studies for major depressive disorder this year, with a typical two-year enrollment and readout timeline [87] Question: How does the PK profile of 1284 compare with lumateperone? - Management indicated that 1284 has advantages for elderly patients due to its rapid absorption and metabolic stability, which are beneficial for the targeted indications [72]