Core Insights - Vanda Pharmaceuticals reported strong commercial execution in Q3 2025, with total net product sales reaching $56.3 million, an 18% increase year-over-year, driven by a 31% increase in Fanapt sales and a 35% growth in prescriptions [2][7] - The company is advancing its pipeline with multiple near-term regulatory milestones, including the NDA for tradipitant and Bysanti, both under FDA review, and the anticipated submission of the imsidolimab BLA [2][6] Financial Highlights - In Q3 2025, Vanda reported a net loss of $22.6 million, compared to a net loss of $5.3 million in Q3 2024, with diluted net loss per share at $0.38 [4][7] - For the first nine months of 2025, the net loss was $79.3 million, compared to $14.0 million in the same period of 2024, with diluted net loss per share at $1.35 [5][7] Operational Highlights – Commercial - Fanapt net product sales increased by 31% to $31.2 million in Q3 2025 compared to Q3 2024, while HETLIOZ sales were stable at $18.0 million, a 1% increase [7][6] - The direct-to-consumer campaign launched in Q1 2025 has significantly improved brand awareness for Fanapt and PONVORY [7] Operational Highlights – Regulatory & Clinical Development - The NDA for tradipitant for motion sickness is under FDA review with a PDUFA target action date of December 30, 2025, and the Bysanti NDA for bipolar I disorder and schizophrenia has a PDUFA target action date of February 21, 2026 [6][7] - A clinical study of tradipitant in preventing vomiting induced by Wegovy is complete, with results expected in Q4 2025 [7]

Financial Data and Key Metrics Changes - For the full year 2025, the company projects total revenues between $210 million and $250 million, with a midpoint of $230 million [23] - In the second quarter of 2025, the company reported revenue of $52.6 million, with net product sales from Fanapt at $29.3 million, Hetlioz at $16.2 million, and Ponvory at $7.1 million [23] - For the six months ended June 30, 2025, total revenue was approximately $103 million, with Fanapt being the lead revenue generator at approximately $53 million [23] - Operating expenses for the same period were approximately $182 million, resulting in a net loss of approximately $57 million [23] - The company ended the second quarter with approximately $325 million in cash and no debt [4][24] Business Line Data and Key Metrics Changes - Fanapt has seen significant prescription growth, reaching approximately 2,300 TRXs per week in mid-August 2025, compared to 1,300 to 1,400 TRXs per week around the same time last year [5] - New-to-brand prescriptions for Fanapt increased to about 240 NBRXs per week recently, up from about 40 NBRXs per week at the same time last year [5] - Hetlioz continues to face revenue erosion due to generic competition but maintains the majority of its patient population [6][7] - Ponvory, acquired from Johnson & Johnson, has shown higher patient demand in the second quarter of 2025 compared to the first quarter post-acquisition [9] Market Data and Key Metrics Changes - The company is focused on expanding its commercial footprint in the U.S. for Fanapt, increasing its sales representatives from approximately 150 to about 300 [4] - The company is pursuing FDA approval for Bysanti, with a PDUFA date set for February 21, 2026, and is also working on a clinical program for major depressive disorder [5][11] Company Strategy and Development Direction - The company aims to increase revenue both organically through existing products and through business development opportunities, as evidenced by the acquisition of Ponvory and in-licensing of imsidolumab [9][10] - The strategic focus includes advancing the pipeline with upcoming regulatory milestones that could increase the number of commercialized products from three to potentially six by the end of next year [10] - The company is committed to enhancing patient access and affordability for its medications while engaging directly with consumers [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming regulatory milestones and the potential for increased commercial presence [10] - The company remains focused on retaining market share for Hetlioz despite generic competition and is pursuing additional indications for the product [11] - Management highlighted the significant unmet medical need for gastroparesis and the potential market opportunity for tradipitant if approved [17] Other Important Information - The company has a robust pipeline with several products at various stages of development, including tradipitant for gastroparesis and motion sickness, with PDUFA dates approaching [12][16] - The company is also pursuing additional treatments for Ponvory in ulcerative colitis and psoriasis [12] Q&A Session Summary Question: What is the expected revenue for 2025? - The company projects total revenues between $210 million and $250 million for 2025, with a midpoint of $230 million [23] Question: How is the commercial launch of Ponvory progressing? - The company noted that patient demand for Ponvory in the second quarter was higher than in the first quarter post-acquisition, indicating positive momentum [9] Question: What are the plans for Hetlioz in light of generic competition? - Management stated that they are focused on retaining market share and pursuing additional indications for Hetlioz, particularly in the Smith-Magenis syndrome market [11]