Release Date: July 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- FDA approval of Fanapt for the treatment of bipolar I disorder, expanding its commercial potential.
- Significant expansion of the sales force, tripling in size to support the commercial launch of Fanapt and Ponvory.
- Positive early indicators of new Fanapt starts, showing promising trends in new prescriptions.
- Introduction of Ponvory revenue following its acquisition, contributing to revenue diversification.
- Strong cash position with $387.7 million in cash, cash equivalents, and marketable securities as of June 30, 2024.
Negative Points
- Total revenues for the first six months of 2024 decreased by 10% compared to the same period in 2023.
- Fanapt net product sales decreased by 7% for the first six months of 2024 compared to the same period in 2023.
- Hetlioz net product sales decreased by 37% for the first six months of 2024 due to the introduction of generic versions.
- Reported a net loss of $8.7 million for the first six months of 2024 compared to net income of $4.8 million for the same period in 2023.
- Operating expenses increased by $7.9 million for the first six months of 2024, driven by higher SG&A expenses and legal activities.
Q & A Highlights
Q: Can you share any feedback from prescribers following the recent label expansion of Fanapt?
A: Despite competition, there is significant unmet medical need for bipolar I disorder. Early signs from IQVIA data show positive trends in new patient starts. Full marketing operations are expected to be in place by Q4 2024, and we anticipate revenue growth, although it may take a few months to see clear effects. - Mihael Polymeropoulos, CEO
Q: How do you plan to respond to the potential approval of KarXT, a new entrant in the psychosis treatment market?
A: We welcome new mechanisms of action and believe Fanapt's well-known tolerability profile will differentiate it. Fanapt has been in the market for 15 years, providing familiarity and a new utility for prescribers. - Mihael Polymeropoulos, CEO
Q: Regarding tradipitant, how do you view its potential in gastroparesis versus motion sickness?
A: Tradipitant has shown significant efficacy in treating gastroparesis, with strong patient testimonials. For motion sickness, we have a complete efficacy and safety package and plan to seek FDA approval later this year. - Mihael Polymeropoulos, CEO
Q: What assumptions are behind the wide revenue guidance range for the second half of 2024?
A: The range accounts for the trajectory of Fanapt and Ponvory launches. Quick results could place us at the high end, while slower uptake might position us in the middle or lower end of the range. - Kevin Moran, CFO
Q: Can Vanda be cash flow positive by the end of 2024?
A: At the high end of our revenue range, we could be around cash breakeven or slightly positive. The midpoint suggests a smaller cash burn. Future revenue growth could necessitate additional investments or convert efficiently into positive EPS. - Kevin Moran, CFO
Q: What is your launch strategy for tradipitant if approved for gastroparesis?
A: We have a well-prepared launch plan, including understanding the target population, cultivating relationships with key opinion leaders, and planning sales force size, speakers programs, and direct-to-consumer campaigns. - Mihael Polymeropoulos, CEO
Q: How many sales reps did you have earlier in the year, given the sales force is now three times larger?
A: We had about 50 sales reps earlier in the year, and now we have a little north of 150. - Kevin Moran, CFO
Q: What are the early indicators of new Fanapt starts?
A: Early indicators from IQVIA data show positive trends in new patient starts (NBRx), which typically lead to new prescriptions (NRx) and total prescriptions (TRx). - Mihael Polymeropoulos, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
