Release Date: February 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: With regard to Fanapt, where do you think you're picking up traction, and what types of prescribers? Also, will the 50% growth in the sales force be sufficient to compete with larger pharma companies? A: The growth is coming from prescribers treating patients with bipolar disorder, distinct from those treating schizophrenia. The sales force expansion to 300 reps is likely on the lower side, but it's crucial to balance rapid growth with quality training. While larger companies like BMS and J&J may focus on schizophrenia and major depression, respectively, our focus remains on bipolar disorder. - Mihael Polymeropoulos, CEO
Q: Regarding the direct-to-consumer (DTC) advertising for Fanapt, do you think bipolar patients will respond to the messaging and discuss it with their prescribers? A: Yes, the DTC campaign targets bipolar I disorder patients. Previous campaigns in this category have increased awareness and confidence among patients and prescribers. Vanda has a strong track record in launching efficient DTC campaigns, and we are prepared to make significant investments based on ROI. - Mihael Polymeropoulos, CEO
Q: Can you provide insights into the rationale behind the Phase III study for Bysanti as a once-a-day adjunctive treatment for major depressive disorder (MDD)? A: Based on our experience with Fanapt and the pharmacokinetics of Bysanti, we believe a once-a-day administration is feasible and potentially more convenient for MDD patients. Our studies suggest that a 12 mg once-a-day dose does not present significant peak-to-trough issues. - Mihael Polymeropoulos, CEO
Q: Regarding the iloperidone long-acting injectable, when do you anticipate enrolling the first patient, and how do you view the competitive landscape? A: We are ready to initiate the program imminently. The initial treatment period is about 12 weeks, followed by re-randomization for relapse prevention. We are in discussions with the FDA regarding study design due to IRB concerns about placebo-controlled studies. We expect results by 2027. The injectable antipsychotic market presents a significant opportunity. - Mihael Polymeropoulos, CEO
Q: Does the 2025 revenue guidance include projected contributions from tradipitant or imsidolimab? A: No, the guidance range is based solely on currently commercialized products and indications. Any positive developments with Fanapt or PONVORY could push us toward the upper end of the range. - Mihael Polymeropoulos, CEO
Q: What impact do you anticipate from broader reimbursement changes in 2025? A: The main change is the Medicare benefit redesign, which affects the catastrophic portion of coverage, requiring a manufacturer contribution. This change is factored into our 2025 projections. - Kevin Moran, CFO
Q: What compelled you to provide 2030 revenue guidance, and how much of the $750 million psychiatry target is based on yet-to-be-approved products? A: The guidance reflects our confidence in the growth of Fanapt and the potential approval of Bysanti for bipolar I disorder and schizophrenia, as well as its label expansion to MDD. The economics of Bysanti are expected to be favorable compared to Fanapt. - Kevin Moran, CFO
Q: Regarding HETLIOZ, how much sales are generated from formulations or indications not facing generic competition? A: We haven't provided a breakout by geography or indication, so I can't offer further details on that. - Kevin Moran, CFO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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