Vanda (VNDA) Q3 2025: FNAP Prescriptions Up 35% as Bipolar Indication Drives Commercial Surge

October 29, 2025 | By EarningsIQ Research

Vanda’s Q3 revealed a pivotal inflection in commercial execution, with FNAP’s bipolar launch sharply accelerating prescription growth and market reach. While Hetlios and Ponvori showed mixed trends, the company’s pipeline momentum and regulatory progress set up a potentially transformative 2026. Investors should monitor Vanda’s ability to translate expanded sales capacity and upcoming product launches into sustained revenue growth amid rising operating costs and ongoing generic threats.

Summary

• FNAP Bipolar Launch Unlocks Demand: FNAP prescription growth signals successful sales force expansion and new indication traction.
• Pipeline Milestones Approach: Multiple FDA reviews and submissions position Vanda for up to six marketed products in 2026.
• Cash Burn and Guidance Trim: Elevated investment narrows guidance, spotlighting execution risk as new launches ramp.

Performance Analysis

Vanda delivered 18% year-over-year revenue growth in Q3, powered by FNAP, atypical antipsychotic, as the bipolar disorder indication and sales force expansion drove a 31% rise in FNAP net sales and a 35% jump in total prescriptions (TRx) versus the prior year. New-to-brand prescriptions (NBRx) for FNAP surged 147% year-over-year, reflecting strong new patient uptake and the impact of a doubled sales force now reaching all 50 states. Hetlios, sleep disorder therapy, maintained market share leadership despite generic competition, though its revenue was flat year-over-year and management cautioned on potential future volatility due to inventory and payer dynamics. Ponvori, multiple sclerosis therapy, rebounded modestly with a 20% year-over-year revenue increase, but remains in early commercial stages after the recent sales force build-out.

Operating expenses rose sharply, up nearly 50% year-over-year, as Vanda invested heavily in commercial infrastructure, direct-to-consumer (DTC) campaigns, and R&D for both current and pipeline assets. The company recorded a net loss of $22.6 million for the quarter, with cash and equivalents declining by $31.8 million sequentially, ending at $293.8 million. Management narrowed full-year revenue guidance to the lower end of the prior range, reflecting strong FNAP momentum but cautioning on Hetlios variability and ongoing investment drag.

• FNAP Commercial Expansion: Sales force doubled to 300 reps, driving prescription and new patient growth across all states.
• Hetlios Market Share Resilience: Maintains leadership despite generics, but inventory and payer patterns inject revenue unpredictability.
• Ponvori Early Uptick: Underlying patient demand grows for second consecutive quarter, but revenue impact remains modest as launch matures.

Vanda’s commercial engine is gaining traction, but scaling costs and product mix headwinds highlight the importance of pipeline conversion and disciplined execution in coming quarters.

Executive Commentary

Strategic Positioning

1. FNAP Bipolar Indication: Market Penetration and Sales Force Leverage

FNAP’s bipolar disorder launch is the core commercial growth engine, with sales force expansion to 300 representatives and broad prescriber outreach driving a 35% increase in total prescriptions. The promotional sensitivity of the atypical antipsychotic class, combined with starter and copay programs, positions FNAP to capture further share ahead of potential generic entry. Management is prioritizing continued sales force productivity and targeted speaker programs to reinforce prescriber education.

2. Pipeline Progress: Regulatory Catalysts and Portfolio Diversification

Multiple near-term FDA milestones are set to transform Vanda’s portfolio, with tradipitant (motion sickness) and Bisanti (bipolar I and schizophrenia) under review and imcidolimab (generalized pustular psoriasis) BLA submission expected in Q4. Collaborative frameworks with the FDA are in place to expedite resolution of clinical holds and supplemental indications, while ongoing Phase III programs (e.g., Bisanti in MDD, iloperidone LAI) target further label expansion and lifecycle management.

3. Commercial Infrastructure and DTC Investment: Building Brand and Demand

Vanda is investing heavily in commercial infrastructure, including DTC campaigns and targeted sponsorships to support both current and future launches. The Ponvori sales force, now at 50 reps, is in early ramp, with underlying demand showing early signs of recovery. Management’s focus on brand visibility and consumer-centric strategies is designed to support rapid uptake of new approvals in 2026, particularly in consumer-facing indications like jet lag and motion sickness.

4. Portfolio Resilience Amid Generic and Pricing Pressure

Hetlios continues to hold majority market share despite three generics, but revenue is increasingly subject to specialty pharmacy inventory fluctuations and payer dynamics. Management flags potential for significant sales volatility as inventory levels normalize and generic competition persists. Ponvori, acquired from J&J, is still in relaunch mode, with revenue recognition impacted by prior underinvestment and ongoing payer disputes.

Key Considerations

Vanda’s Q3 underscores a company at a commercial and clinical inflection, balancing robust top-line growth from FNAP against rising operating costs and execution risk in the pipeline and legacy franchises.

Key Considerations:

• FNAP Prescription Momentum: Sustained double-digit script growth and new patient starts highlight effective sales execution, but future durability will hinge on payer access and competitive response.
• Pipeline Approvals as Growth Catalyst: FDA decisions for tradipitant and Bisanti could double the marketed portfolio and drive material revenue inflection in 2026.
• Cost Structure and Cash Burn: SG&A and R&D investments have materially increased losses and reduced cash, raising the bar for future commercial returns and requiring disciplined capital allocation.
• Hetlios and Ponvori Variability: Hetlios faces ongoing generic erosion and inventory-driven revenue volatility, while Ponvori’s trajectory depends on sales force maturation and payer engagement.

Risks

Vanda faces execution risk on both commercial and pipeline fronts, with high fixed costs and cash burn amplifying the need for successful product launches and regulatory wins. Hetlios is exposed to generic-driven volume and pricing pressure, while Ponvori’s revenue is still stabilizing post-acquisition. Regulatory timelines and FDA review outcomes remain key swing factors, and any delay or negative decision could materially impact growth and liquidity.

Forward Outlook

For Q4 2025, Vanda guided to:

• Total revenues from FNAP, Hetlios, and Ponvori between $210 million and $230 million (narrowed from prior $210 million to $250 million)
• Year-end 2025 cash of $260 million to $290 million (lowered from $280 million to $320 million)

For full-year 2025, management expects:

• Continued FNAP revenue growth with quarterly acceleration as expanded sales force gains traction
• Hetlios revenue variability due to specialty pharmacy inventory and generic competition

Management emphasized that FNAP’s growth trajectory and pipeline approvals will drive 2026 revenue potential, but flagged that cash guidance reflects ongoing investment in launches, DTC, and R&D.

Takeaways

• FNAP is delivering prescription-led growth, validating the sales force expansion and new indication strategy.
• Pipeline execution and regulatory clarity will determine whether Vanda can offset Hetlios and Ponvori volatility and achieve sustained multi-product growth in 2026.
• Investors should watch for: FDA decisions, FNAP script durability, cash burn trends, and commercial traction for new launches as critical drivers of future valuation.

Conclusion

Vanda’s Q3 marks a successful pivot toward commercial scale and pipeline-driven optionality, but the company’s rising cost base and narrowed guidance underscore the need for flawless execution in both product launches and regulatory navigation. 2026 will be a proving ground for whether FNAP’s momentum and pipeline catalysts can translate into durable, profitable growth.

Industry Read-Through

Vanda’s results highlight the importance of indication expansion and sales force leverage in specialty pharma, especially in competitive, promotionally sensitive categories like CNS and MS. Generic encroachment and inventory-driven revenue swings are persistent headwinds for legacy brands, underscoring the need for pipeline diversification and payer engagement. Direct-to-consumer investment and FDA collaboration frameworks are increasingly critical for companies seeking to accelerate launches in consumer-facing and orphan indications. The evolving regulatory landscape and commercial model will shape sector winners as the bar for both innovation and execution rises.

VNDA Healthcare Pharmaceuticals Pipeline Commercial Launch Direct-to-Consumer Specialty Pharma Regulatory