Intra-Cellular Therapies(ITCI) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenues for Q3 2021 grew to $22.2 million, compared to $7.4 million in Q3 2020 [11][28] - CAPLYTA net product revenues reached $21.6 million, up from $19 million in Q2 2021 and $7.4 million in Q3 2020 [11][28] - Net loss for Q3 2021 was $76.9 million, compared to a net loss of $55.2 million in Q3 2020 [30] Business Line Data and Key Metrics Changes - Total prescriptions for CAPLYTA increased by 15% quarter-over-quarter and approximately 200% year-over-year [11][22] - CAPLYTA's prescription growth trajectory continued despite disruptions from COVID-19 [11][22] Market Data and Key Metrics Changes - The upcoming FDA PDUFA date for CAPLYTA's label expansion into bipolar depression is December 17, 2021 [10][12] - There are over 11 million Americans living with bipolar disorder, representing a significant market opportunity for CAPLYTA [12][14] Company Strategy and Development Direction - The long-term vision is to establish lumateperone as the treatment of choice across a broad range of depressive disorders, starting with bipolar depression [14][16] - The company is expanding its salesforce from 240 to 320 representatives to enhance market presence [25][75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial plan for CAPLYTA, anticipating strong uptake in prescriptions following the approval for bipolar depression [27][69] - The company noted that the COVID-19 pandemic has impacted patient engagement but is seeing improvements as vaccination rates increase [22][35] Other Important Information - The company ended Q3 2021 with $478.7 million in cash and equivalents, down from $658.8 million at the end of 2020 [30][21] - Research and Development expenses for Q3 2021 were $27 million, significantly higher than $10.3 million in Q3 2020 due to increased clinical trial costs [29] Q&A Session Summary Question: How is the commercial landscape shifting with COVID-19? - Management noted that as COVID-19 cases decrease and vaccination rates increase, more psychiatry offices are reopening, allowing for greater access for the salesforce [35] Question: What is the status of the PDUFA date? - Management confirmed that everything is on track for the PDUFA date of December 17, 2021 [37][41] Question: How will the launch dynamics for bipolar depression be affected by other launches? - Management indicated that they are focused on their launch and have a comprehensive commercial plan in place [44] Question: What are the expectations for the baseline MADRS scores in the depression study? - Management expects baseline scores to be in the range of 28 to 30 [49] Question: What is the gross to net ratio for CAPLYTA? - The gross to net ratio has been consistent, expected to remain in the mid-20s to low 30s range [58] Question: How will the company track prescriptions for schizophrenia versus bipolar depression? - Management stated that there are data sources available to track prescriptions by indication, although they are not perfect [66] Question: What are the expectations for the pace of the bipolar depression launch post-approval? - Management plans to launch immediately upon approval, although they do not expect a significant spike in prescriptions during the holiday weeks [78] Question: How does the company view xUS opportunities? - Management indicated that they will focus on the bipolar indication first before exploring xUS opportunities [90]