Release Date: October 30, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- CAPLYTA's net sales increased by 39% year-over-year, reaching $175.2 million in Q3 2024.
- The company raised its 2024 full-year net sales guidance to $665 million to $685 million.
- CAPLYTA demonstrated strong efficacy and safety in Phase 3 studies for major depressive disorder (MDD), expanding its potential market.
- The company has a robust pipeline, including promising programs like ITI-1284 for generalized anxiety disorder (GAD) and Alzheimer's disease.
- Intra-Cellular Therapies Inc (ITCI, Financial) has a strong financial position with $1 billion in cash and investments as of September 30, 2024.
Negative Points
- Increased selling, general, and administrative expenses, rising to $132.1 million in Q3 2024 from $105.2 million in the same period in 2023.
- Research and development expenses also increased significantly, reaching $66.8 million in Q3 2024 compared to $41.6 million in Q3 2023.
- The company faces competition in the antipsychotic market, with new entrants like KarXT potentially impacting market dynamics.
- The long-term success of CAPLYTA in MDD and other indications is contingent on future regulatory approvals and market acceptance.
- The expansion of the sales force and commercialization efforts may take time to fully optimize and yield results, particularly in primary care settings.
Q & A Highlights
Q: Congrats on the quarter and the strong execution. My question is around your sales opportunity comment for CAPLYTA, $5 billion over the next 10 years. Are you expecting MDD sales to be meaningfully larger than bipolar, and is it fair to assume CAPLYTA will be prescribed more than other branded antipsychotics?
A: Mark Neumann, Chief Commercial Officer: The forecast reflects our confidence that CAPLYTA will become a leading treatment option across mood disorders, primarily driven by bipolar depression and MDD, with schizophrenia contributing less. We expect significant market share gains in bipolar depression and a market-leading share among branded antipsychotics in MDD.
Q: Can you touch on what prompted you to unveil this $5 billion long-term target for CAPLYTA now?
A: Sharon Mates, CEO: We are continuously asked about the market opportunity for CAPLYTA. As we mature, it's time to share our internal forecasts, which are based on market research and internal confidence. The results of Studies 501 and 502, along with our primary care sales force expansion, have increased our confidence in CAPLYTA's long-term potential.
Q: How important is the long-acting injectable (LAI) for the lumateperone franchise versus other pipeline candidates like ITI-1284?
A: Sharon Mates, CEO: The LAI is being developed to provide another option for patients. We are testing four formulations and will prioritize those with the best profiles. The LAI is separate from our CAPLYTA franchise, which we expect to grow substantially. ITI-1284 is also a separate pipeline with significant opportunities, particularly in GAD.
Q: Regarding the guide, what are the tailwinds for the expected acceleration in growth in Q4?
A: Sanjeev Narula, CFO: We had strong Q3 growth despite summer seasonality. We expect Q4 to be stronger, with some impact from the primary care sales force expansion. We anticipate sequential growth of 11% at the midpoint, which is reasonable and supports our guidance.
Q: What are your expectations for demand for the long-acting lumateperone formulation?
A: Sharon Mates, CEO: It's too soon to tell, but we don't expect a huge impact on our oral franchise. Current penetration of LAIs in schizophrenia is low, around 5-10%. Given CAPLYTA's safety and tolerability, we believe patients prefer the oral formulation.
Q: Can you elaborate on the differentiation of ITI-1284 from CAPLYTA, particularly regarding the somnolence rate?
A: Sharon Mates, CEO: In Phase 1 studies, ITI-1284 showed a good safety profile with decreased somnolence in elderly volunteers. The deuterated form expresses more of the parent compound than lumateperone, and we are exploring its implications for efficacy and dosing.
Q: Regarding your GAD program, what kind of market research have you done on the use of atypical antipsychotics for GAD?
A: Mark Neumann, Chief Commercial Officer: GAD is highly prevalent, and many patients do not respond to first-line therapies. Although no antipsychotics are currently approved for GAD, there is off-label use, especially in patients with comorbid conditions. We believe ITI-1284 could penetrate both the comorbid and standalone GAD markets.
Q: On the expectation of CAPLYTA reaching $5 billion in sales, what kind of changes in pricing over time are built into that projection?
A: Mark Neumann, Chief Commercial Officer: We've assumed moderate improvement in net selling price over time, incorporating potential impacts from the Inflation Reduction Act.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
