#United States #Washington #Vanda Pharmaceuticals #Fanapt #BIosanti

Vanda Pharmaceuticals Achieves Significant Financial Milestone in Q3 2025

Vanda Pharmaceuticals Inc. has reported a strong financial performance for the third quarter of 2025, marking a pivotal moment for the company and its stakeholders. The quarter ended on September 30, 2025, reflects a robust 31% increase in net product sales of Fanapt®, reaching $31.2 million compared to Q3 2024. This growth is part of a wider trend as Vanda's total net product sales soared to $56.3 million, an 18% increase year-over-year, driven by impressive sales across its product range including HETLIOZ® and PONVORY®.

Leadership Insights

Dr. Mihael H. Polymeropoulos, President and CEO of Vanda, noted the positive market reception, stating, "This quarter demonstrates our effective commercial strategies, leading to a substantial 35% rise in prescriptions and stable performance from HETLIOZ, which generated $18.0 million in sales. We remain optimistic about our expanding pipeline with several significant regulatory milestones on the horizon."

Pipeline Developments

Vanda is actively pursuing several key product developments currently under review by the FDA. Notably, the Bysanti™ New Drug Application (NDA) for bipolar I disorder and schizophrenia has a target action date set for February 21, 2026. Additionally, the NDA for Tradipitant, designed for motion sickness, is under FDA review with a decision anticipated by December 30, 2025. Moreover, the company is preparing to submit a Biologics License Application (BLA) for Imsidolimab aimed at treating generalized pustular psoriasis in the upcoming quarter.

Financial Highlights

In-depth examination of Vanda's financials reveals significant insights:

• - Total Net Product Sales: In Q3 2025, sales totaled $56.3 million, up from $47.7 million in Q3 2024.
• - Fanapt® Sales: Specifically surged to $31.2 million, illustrating a 31% increase from the previous year.
• - HETLIOZ® and PONVORY® Sales: Achieved $18.0 million and $7.0 million, respectively, indicating steady demand.
• - Year-to-Date Sales: Over the first nine months of 2025, net product sales rose to $158.9 million, surpassing the $145.6 million recorded in the same period of 2024.

While Vanda celebrates these victories, it also contends with a net loss of $22.6 million for the third quarter, a significant shift from the $5.3 million loss reported in Q3 2024. The increase in net losses, primarily due to expanded operational costs and substantial investments into R&D, raises essential questions about future profitability.

Strategic Investments and Future Guidance

Vanda is not just resting on its laurels; it is also strengthening its commercial infrastructure by enhancing brand visibility through strategic sponsorships and direct-to-consumer campaigns, which have already yielded fruitful results. Looking forward, the company is adjusting its financial guidance for 2025, now projecting total revenues between $210 and $230 million and ending cash between $260 and $290 million.

Concluding Thoughts

With its clear focus on innovation and strategic growth, Vanda Pharmaceuticals is positioning itself not only for immediate success but for long-term leadership in the biopharmaceutical industry. The anticipated regulatory decisions, coupled with the company's expanding product offerings, inspire optimism for what lies ahead in 2026 and beyond. Investors, along with stakeholders across the industry, will no doubt be watching closely as these developments unfold.

In summary, Vanda Pharmaceuticals is at a significant juncture, with strong sales performance and a promising pipeline underscoring its commitment to meeting the medical needs of patients while navigating the complexities of modern healthcare challenges.