Vanda narrows 2025 revenue guidance to $210M-$230M as Fanapt grows and investments pay off
Strong Commercial Performance and Strategic Pipeline Advancements
Vanda Pharmaceuticals Inc. (VNDA) reported impressive results during its Q3 2025 earnings call, highlighting strong commercial execution and continued progress in its late-stage pipeline. The company’s CEO, Mihael Polymeropoulos, emphasized that total net product sales reached $56.3 million, reflecting an 18% year-over-year increase. This growth was primarily driven by a 31% rise in Fanapt sales and a 35% increase in prescriptions.
Fanapt's expansion was fueled by the recent launch of the bipolar I indication, which has significantly contributed to its performance. Additionally, HETLIOZ maintained stable sales at $18 million for the quarter, demonstrating consistent demand despite market challenges. The CEO also outlined several key developments in the company’s pipeline, including the ongoing FDA review of the tradipitant NDA with a PDUFA date of December 30, 2025, and the Bysanti NDA with a PDUFA date of February 21, 2026. A planned submission of the imsidolimab BLA for generalized pustular psoriasis is expected in Q4.
The company is also investing heavily in commercial infrastructure, focusing on increasing brand visibility and targeted sponsorships to support long-term market leadership and future product launches. These efforts are designed to strengthen Vanda’s position in the competitive pharmaceutical landscape.
Financial Highlights and Outlook
The CFO, Kevin Moran, provided an overview of the company’s financial performance, noting that total revenues for the first nine months of 2025 reached $158.9 million, a 9% increase compared to the same period in 2024. This growth was largely attributed to the success of Fanapt, which saw net product sales of $31.2 million in Q3 2025—up 31% year-over-year and 7% from the previous quarter. Total prescriptions for Fanapt increased by 35% year-over-year and 11% sequentially, with new patient starts rising by 147% year-over-year and 14% from Q2 2025.
HETLIOZ experienced a 1% year-over-year increase in net product sales, reaching $18 million for the quarter, while PONVORY generated $7 million in sales, up 20% from Q3 2024 but slightly lower than Q2 2025. Despite this, underlying patient demand for PONVORY continued to grow for the second consecutive quarter.
Vanda reported a net loss of $22.6 million for Q3 2025, compared to a net loss of $5.3 million in the same period in 2024. Operating expenses rose to $87.5 million, driven by higher SG&A and R&D costs related to commercial launches and new product development. Cash, cash equivalents, and marketable securities were $293.8 million as of September 30, 2025, down $31.8 million from June 30, 2025.
Updated Guidance and Strategic Focus
Management revised its 2025 financial guidance, projecting total revenues from Fanapt, HETLIOZ, and PONVORY between $210 million and $230 million, with year-end 2025 cash between $260 million and $290 million. This guidance reflects a narrowing of the previous range, which had been $210 million-$250 million for revenue and $280 million-$320 million for cash. The adjustment accounts for strong Fanapt growth, which is expected to continue on a quarterly basis, as well as the impact of significant investments in R&D and commercial infrastructure.
Analysts raised questions about the variability in HETLIOZ sales, with management acknowledging that factors such as inventory shifts and generic competition can influence quarterly results. The company also discussed the potential approval of tradipitant, with the CEO expressing optimism about a possible approval by the end of 2025. Regarding imsidolimab, management expects a 6-month priority review and anticipates results by the end of next year.
Regulatory Progress and Market Challenges
The earnings call also covered regulatory updates, with discussions around the Bysanti NDA and the commercial strategy for switching from Fanapt. Management highlighted positive interactions with the FDA and emphasized leveraging the highly promotionally sensitive nature of the antipsychotic class through incentives such as starter packs and co-pay programs.
In terms of marketing strategies for upcoming approvals, the CEO outlined a consumer-centric approach, including plans for concierge services aimed at supporting market entry in the first half of 2026. Analysts remained focused on regulatory timelines, guidance implications, and the impact of strategic investments on future growth.
Risks and Future Outlook
Despite the strong performance, management acknowledged several risks, including variability in HETLIOZ sales due to specialty pharmacy inventory and ongoing generic competition. The company also noted that a change in the need for a valuation allowance against deferred tax assets could result in a noncash income tax expense.
Looking ahead, Vanda remains focused on expanding its commercial capacity, advancing its pipeline, and preparing for strategic product launches in 2026. While the company faces challenges, its confidence in commercial momentum and regulatory progress underscores its commitment to long-term growth.
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