Vanda Pharmaceuticals Inc. (VNDA)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 revenue was $56.3M, up 18% YoY and 7% QoQ, driven by Fanapt strength; diluted EPS was -$0.38, better than consensus EPS of -$0.45, but revenue missed the $58.7M consensus, reflecting Helios variability and inventory dynamics .*
• Guidance narrowed: total 2025 revenues cut to $210–$230M (from $210–$250M) and year-end cash lowered to $260–$290M (from $280–$320M), citing increased SG&A and R&D investments to support commercial and pipeline execution .
• Commercial KPIs inflected: Fanapt TRx +35% YoY and NBRx +147% YoY; sales force expanded to ~300 reps, supporting sequential script growth and QoQ revenue acceleration .
• Near-term regulatory catalysts: tradipitant PDUFA 12/30/2025; Bysanti PDUFA 2/21/2026; HETLIOZ jet lag sNDA re-review by 1/7/2026 under a collaborative FDA framework—key stock-reaction drivers into 4Q–1Q .

What Went Well and What Went Wrong

What Went Well

• Fanapt outperformance: “total net product sales reaching $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions” .
• Commercial execution: “face-to-face calls in the third quarter of 2025 were more than 20% higher than… Q2 2025, and more than twice… Q3 2024,” with a ~300-rep sales force post Q2 expansion .
• Pipeline momentum and FDA framework: tradipitant and Bysanti under active NDA reviews; imsidolimab BLA submission targeted for Q4; collaborative path with FDA to resolve HETLIOZ jet lag and tradipitant hold disputes .

What Went Wrong

• Profitability pressure: net loss widened to -$22.6M vs -$5.3M YoY; operating expenses rose to $87.5M (from $58.7M), driven by SG&A and R&D tied to launches and imsidolimab license costs .
• Helios revenue variability and potential declines: inventory stocking swings at specialty pharmacies/distributors; management cautions future periods may reflect lower unit sales due to elevated inventory reduction and ongoing generic pressure .
• Cash draw: cash, equivalents, and marketable securities fell by $31.8M QoQ to $293.8M, reflecting net losses and timing of working-capital cash receipts/payments .

Financial Results

Consolidated Financials vs Prior Periods

Margins

Values retrieved from S&P Global.*

Segment Breakdown (Net Product Sales)

KPIs

Guidance Changes

Management attributes the lower ranges to stepped-up SG&A for commercial build-out and higher R&D spend (e.g., imsidolimab license), while maintaining Fanapt revenue growth expectations .

Earnings Call Themes & Trends

Management Commentary

• “This quarter reflects strong commercial execution, with total net product sales reaching $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions.” — CEO Mihael H. Polymeropoulos .
• “We believe that these milestones, combined with our collaborative framework with the FDA, will position Vanda for sustained growth and expanded therapeutic impact in 2026 and beyond.” — CEO .
• “Face-to-face calls in the third quarter of 2025 were more than 20% higher than… Q2 2025, and… more than twice… Q3 2024.” — CFO Kevin Moran .
• “Vanda could have six products commercially available in 2026.” — CFO .

Q&A Highlights

• Approval timelines: Management “optimistic” on tradipitant motion sickness by 12/30/2025; HETLIOZ jet lag re-review by early January 2026, under an FDA collaborative framework; if partial hold lifted, tradipitant path to approval strengthened .
• PONVORY growth trajectory: Underlying demand increased in back-to-back quarters; recent commercial build (50 reps) should support continued growth though quarterly revenue may be impacted by SP/SD purchase timing .
• Imsidolimab review: Expect a six-month priority review given rare/orphan indication; BLA submission targeted for Q4 .
• Guidance clarifications: Revenue range narrowed due to Helios purchase timing variability; Fanapt underpins sequential growth; cash lowered due to elevated SG&A and R&D investment cadence .
• Bysanti transition strategy: Atypical antipsychotic class is promotion-sensitive and high-switch; starter/titration packs and copay programs envisioned to facilitate transition from Fanapt; once-daily adjunct MDD indication aims to differentiate .

Estimates Context

Values retrieved from S&P Global.*

Implications: Q3 delivered an EPS beat and revenue miss; the pattern across 2025 shows revenue beats in Q1, misses in Q2–Q3, consistent with Helios purchase timing and inventory commentary, while EPS is leveraged by mix and expense timing .

Key Takeaways for Investors

• Fanapt is the core growth engine; sequential script and revenue momentum should persist as the expanded sales force normalizes its cadence .
• Revenue visibility is partially constrained by Helios inventory dynamics; expect quarter-to-quarter variability and potential declines amid generics .
• 2025 guidance lowered to reflect investment phase; watch SG&A efficiency and R&D milestones to gauge operating leverage into 2026 .
• Near-term catalysts: tradipitant PDUFA (12/30/2025) and HETLIOZ jet lag re-review (by 1/7/2026); any positive decisions can re-rate revenue trajectory and narrative .
• Bysanti strategy aims to leverage promotion-sensitive, high-switch dynamics; subsequent MDD adjunct opportunity (once-daily) could extend franchise and support a Fanapt-to-Bysanti transition .
• Cash runway remains ample at $293.8M, but monitor deferred tax valuation allowance risk (non-cash) and burn tied to commercial build-out and pipeline execution .
• Trading setup: EPS resilience vs consensus and upcoming FDA decisions form the core catalysts; revenue misses vs consensus tied to Helios may cap near-term upside absent regulatory wins .