Vanda Pharmaceuticals Conference Call Summary Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on innovating to enhance people's happiness [2][3] - The company has three commercialized products: - **Fanapt**: Approved for bipolar disorder and schizophrenia in the U.S. - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome in both adults and pediatric populations, with approvals in Europe as well [2][3] - **Ponvory**: Approved for multiple sclerosis, acquired from Johnson & Johnson at the end of 2023 [3] Financial Position - As of Q3 2025, Vanda has approximately $294 million in cash and no debt [3] - 2025 revenue guidance is set between $210 million and $230 million, with Q3 2025 revenue reported at $56.3 million [12][13] Product Pipeline and Regulatory Updates - **Fanapt**: - Pursuing FDA approval for **Basanti**, the active metabolite of Fanapt, with a PDUFA target action date of February 21, 2026 [3][10] - Phase three program for major depressive disorder (MDD) expected to yield results in 2026 [4][10] - Long-acting injectable formulation of Fanapt is in phase three trials [11] - **Hetlioz**: - Re-review of the jet lag supplemental new drug application (SNDA) with an FDA decision expected by January 7, 2026 [4][10] - Pursuing additional indications for Hetlioz, including jet lag and maintaining market share against generics [6][7] - **Ponvory**: - Commercial launch is progressing well, with increased patient demand noted [7][8] - Ongoing phase three programs for psoriasis and ulcerative colitis [12] - **Tradipitant**: - Upcoming PDUFA date for motion sickness on December 30, 2025 [9][12] - Phase two study for nausea in patients taking GLP-1 medications is underway, with results expected in Q4 2025 [9][46] - **Imsidolumab**: - Biologics License Application (BLA) for generalized pustular psoriasis (GPP) expected to be submitted by the end of the year [10] Strategic Focus - Vanda aims to grow revenue organically through existing products and through potential business development opportunities [5] - Focus on increasing access and affordability for patients while engaging directly with consumers [5] Market Dynamics and Competitive Landscape - The antipsychotic market is evolving with new entrants like Kobenphy, which presents both opportunities and challenges [25][26] - The treatment landscape remains promotionally sensitive, with a high switch rate among patients seeking effective medications [27][28] Upcoming Milestones and Expectations - The company is optimistic about the upcoming PDUFA dates and the potential for positive results in ongoing trials [20][32] - The MDD trial is seen as a significant opportunity, with a large addressable market [34][35] - The motion sickness and jet lag markets are expected to be driven by consumer demand, with potential insurance coverage as well [38][40] Conclusion - Vanda Pharmaceuticals is well-positioned with a strong financial foundation and a robust pipeline of products and regulatory submissions. The company is focused on maximizing the potential of its existing products while navigating the competitive landscape and addressing unmet medical needs in various therapeutic areas.

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]