Vanda Pharmaceuticals (VNDA) Conference Summary Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on innovating to enhance people's happiness [4][5] - The company has three commercial products: - **Fanapt**: Approved for schizophrenia and bipolar disorder [5] - **Hetlioz and Hetlioz LQ**: Approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-McGinniss syndrome [5] - **Pomvori**: Approved for multiple sclerosis [5] Financial Position - As of the end of Q2, Vanda had approximately **$325 million** in cash and no debt [7] - Revenue guidance for the year is between **$210 million and $250 million**, with a midpoint of **$230 million** [7] - Expected year-end cash is between **$280 million and $320 million**, with a midpoint of **$300 million** [7] Product Pipeline and Regulatory Updates - Upcoming regulatory submissions include: - **Tradipitant**: NDA for motion sickness with a PDUFA date of **December 30, 2025** [6] - **Basanti**: PDUFA date in **February 2026** for bipolar disorder and schizophrenia [6] - **Imsidolumab**: BLA submission expected later this year for general postural psoriasis (GPP) [6] - Vanda is also developing a long-acting injectable formulation of Fanapt, currently in Phase III for schizophrenia [9] Market Dynamics and Competition - **Hetlioz** faces generic competition since late 2022 but has maintained a majority market share due to patient loyalty [10] - **Pomvori** has seen increased patient demand in Q2 2025 compared to Q1 2025, indicating a positive trend [11] - The company is focused on increasing revenue from existing products and exploring business development opportunities [12] Strategic Focus - Vanda aims to grow revenue organically from existing products and leverage its commercial presence in psychiatry and neurology [12] - The company is committed to increasing access and affordability for patients [13] Fanapt and Basanti Insights - Fanapt has seen a resurgence in prescription growth, particularly after the approval for bipolar disorder [22] - The sales force for Fanapt has doubled from **150 to 300** to enhance market presence [26] - Basanti is expected to provide a significant revenue boost due to its exclusivity and pricing dynamics compared to Fanapt [27][28] Challenges and Considerations - The company acknowledges challenges with Medicaid and commercial coverage but does not see significant hurdles currently [34] - The transition from Fanapt to Basanti is anticipated to be supported by promotional efforts and prescriber engagement [48] Regulatory and Clinical Expectations - Vanda is optimistic about the upcoming PDUFA dates and believes the submission packages are robust [42][44] - The company is preparing for a potential commercial launch of Tradipitant and is focused on restoring Pomvori's growth [14][15] Conclusion - Vanda Pharmaceuticals is positioned for growth with a strong pipeline and strategic focus on expanding its market presence while navigating challenges in the competitive landscape [12][22]