Release Date: August 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- CAPLYTA net product sales increased to $161.3 million in Q2 2024, representing a 46% growth versus the same period in 2023.
- The company announced robust positive results from two Phase 3 clinical trials in major depressive disorder (MDD), supporting an expanded label for CAPLYTA.
- Intra-Cellular Therapies Inc (ITCI, Financial) is on track to submit a supplemental NDA for CAPLYTA for the adjunctive treatment of MDD later this year.
- The company is in a strong financial position, ending Q2 with approximately $1.025 billion in cash, cash equivalents, and investment securities, with no debt.
- The company is expanding its salesforce by approximately 150 representatives to capitalize on the growing opportunity in primary care for bipolar depression.
Negative Points
- Selling, general, and administrative expenses increased to $121.6 million in Q2 2024, up from $101 million in the same period in 2023.
- Research and development expenses rose to $56.2 million in Q2 2024, compared to $49.8 million in the same period in 2023.
- The company is increasing its full-year SG&A expense guidance range to $480 million to $510 million due to salesforce expansion.
- There is potential summer seasonality that could impact script growth in Q3, which is factored into the revised guidance.
- The pediatric program for lumateperone will take longer to yield results compared to adult studies, with no results expected until after 2025.
Q & A Highlights
Highlights from Intra-Cellular Therapies Inc (ITCI) Q2 2024 Earnings Call
Q: As we think about your revised guidance range, do you expect scripts in Q3 to grow at a similar pace or even a stronger pace than what you saw in Q2, or are you factoring in some potential slowdown due to summer seasonality, holidays, and occasions?
A: We typically see some summer seasonality during the third quarter and then a stronger fourth quarter. This is factored into our guidance for the year. We expect a significant increase in the trajectory of prescriptions if and when we get approved for MDD, similar to what we saw with bipolar depression.
Q: With respect to the salesforce expansion, can you confirm what that will bring your total salesforce size to? And what's the right way to think about the additional salesforce expansion plan for next year?
A: We will be adding approximately 150 sales representatives, bringing our total to over 500. We will invest behind the brand at a level that optimizes the launch and growth prospects for CAPLYTA. More details will be shared as we get closer to potential FDA approval.
Q: As we look to the presentations of the MDD data this fall, what are the key things you are looking to highlight to the community?
A: We will highlight the robust efficacy and safety profile of lumateperone, including its favorable metabolic profile and lack of movement disturbances. We will also emphasize the strong efficacy data from our Phase 3 studies.
Q: Do you view the Rexulti launch as a representative comp for an atypical launching into the Alzheimer's disease neuropsych space?
A: It is early days for the Rexulti launch. We believe there is a large opportunity for a product with the right profile, and we are confident in lumateperone's safety and tolerability profile. We will continue to monitor the market and adjust our strategy accordingly.
Q: Can you talk about how you're thinking about business development these days and leveraging your salesforce?
A: We constantly look at BD opportunities, especially those that fit into our current salesforce. We also evaluate earlier-stage opportunities to supplement our robust internal pipeline. We will keep you informed on our progress.
Q: For the MDD trial Study 505, any plan to shut this trial down? And how should we think about R&D spend throughout the balance of the year?
A: We are evaluating the fate of Study 505 and will update you soon. Our R&D spend is guided by the need to generate robust data to inform our decisions on advancing our pipeline.
Q: For 1284 in Alzheimer's disease psychosis, can you talk about your approach versus what others are doing for the indication and your confidence in 1284 for AD psychosis?
A: We believe in the efficacy of 1284 based on its mechanism of action affecting the dopamine, serotonin, and glutamate systems. Our study design includes the BEHAVE-AD psychosis subscale and CGI-S as key endpoints, ensuring we capture the right severity and symptomatology.
Q: How are you thinking about the path to profitability from here as you balance building out a commercial infrastructure and R&D efforts against the backdrop of continued revenue growth?
A: We are focused on becoming profitable while financing our R&D projects. We will keep you updated on our progress towards profitability as we continue to grow our revenue and manage our expenses.
Q: What proportion of bipolar depression patients are treated by primary care physicians, and what growth do you expect from the expanded salesforce?
A: Primary care physicians account for about 25% of all prescriptions for bipolar depression. The expansion allows us to go deeper into primary care and extend our reach, leveraging the growing opportunity in this segment.
Q: On the bipolar mania program, can you talk about how additive you think it is to the overall sales potential of CAPLYTA?
A: The bipolar mania program is part of our agreement with the FDA for pediatric exclusivity. We believe it will add significant value to CAPLYTA's overall sales potential by addressing an unmet need in both adult and pediatric populations.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
