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Vanda Pharmaceuticals Inc. (VNDA)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $52.6M, up 4% year over year, but below Wall Street consensus; diluted EPS was -$0.46 and net loss widened to $27.2M as SG&A and R&D stepped up to fund Fanapt and Ponvory launches and pipeline programs . Q2 revenue missed consensus ($54.8M*) and EPS missed (-$0.36*) as higher commercial spend and declining HETLIOZ weighed on results. Values retrieved from S&P Global.
  • Fanapt net product sales grew 27% YoY to $29.3M; TRx rose ~24% YoY and ~13% QoQ, with NBRx up >200% YoY and >50% QoQ, reflecting launch momentum in Bipolar I .
  • Ponvory sales rose 26% QoQ to $7.1M, but were down 18% YoY due to price/deductions; HETLIOZ fell 13% YoY to $16.2M amid ongoing generic pressure .
  • Guidance maintained: 2025 total revenues $210–$250M and year-end cash $280–$320M; management reiterated revenue back-weighting from Fanapt/Ponvory growth and flagged potential variability/decline in HETLIOZ .
  • Catalysts: Bysanti (milsaperidone) NDA accepted (PDUFA Feb 21, 2026); Tradipitant NDA for motion sickness accepted (PDUFA Dec 30, 2025); Imsidolimab BLA in GPP expected in 2025; an August appeals court decision remanded FDA’s jet lag sNDA denial, potentially reopening HETLIOZ expansion .

What Went Well and What Went Wrong

What Went Well

  • Fanapt momentum: net product sales +27% YoY to $29.3M; “accelerated growth…alongside a broad direct to consumer brand awareness campaign and we expect this trend to continue” — CEO Mihael Polymeropoulos .
  • Demand indicators: Fanapt TRx +24% YoY and +13% QoQ; NBRx +200% YoY and +50% QoQ; “Fanapt was one of the fastest growing atypical antipsychotics…through the first half of 2025” — CFO Kevin Moran .
  • Ponvory uptake: new patient prescriptions reached a record high since Vanda’s launch; QoQ revenue +26% as specialty channel inventory and demand improved .

What Went Wrong

  • Profitability: net loss widened to $27.2M (vs. $4.5M YoY), diluted EPS -$0.46 (vs. -$0.08 YoY), driven by SG&A and R&D investment (opex $91.1M vs. $60.6M YoY) .
  • HETLIOZ headwinds: net product sales down 13% YoY; management warned future declines and variability due to generics and specialty pharmacy inventory normalization .
  • Ponvory pricing/deductions and dispute: YoY decline (-18%) due to lower price net of deductions; $3M variable consideration from 4Q24 remains under gross‑to‑net dispute .

Financial Results

Aggregate Results vs Prior Periods

MetricQ3 2024Q1 2025Q2 2025
Revenue ($USD Millions)$47.651 $50.041 $52.590
Diluted EPS ($USD)-$0.09 -$0.50 -$0.46
Net Loss ($USD Millions)-$5.324 -$29.494 -$27.207
Operating Expenses ($USD Millions)$58.651 $91.069 $91.093
Cash & Marketable Securities ($USD Millions)$376.3 $340.9 $325.6

Segment Breakdown

MetricQ2 2024Q1 2025Q2 2025
Fanapt Net Product Sales ($USD Millions)$23.150 $23.545 $29.294
HETLIOZ Net Product Sales ($USD Millions)$18.708 $20.872 $16.192
Ponvory Net Product Sales ($USD Millions)$8.616 $5.624 $7.104
Total Revenues ($USD Millions)$50.474 $50.041 $52.590

KPIs

KPIQ1 2025Q2 2025
Fanapt TRx YoY Change+14% +24%
Fanapt TRx QoQ Change—+13%
Fanapt NBRx YoY ChangeNearly threefold >200%
Fanapt NBRx QoQ Change—>50%
Ponvory New Patient PrescriptionsRecord high since launch Record high since launch

Actuals vs Consensus

MetricQ1 2025 ConsensusQ1 2025 ActualQ2 2025 ConsensusQ2 2025 Actual
Revenue ($USD)$45.134M*$50.041M $54.767M*$52.590M
Primary EPS ($USD)-$0.597*-$0.50 -$0.357*-$0.46

Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenues ($USD)FY 2025$210–$250M $210–$250M Maintained
Year-end Cash ($USD)FY 2025$280–$320M $280–$320M Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q1 2025)Current Period (Q2 2025)Trend
Fanapt demand and launchQ3 2024 launch in Bipolar I; initial NBRx +90% YoY . Q1 2025: TRx +14% YoY; NBRx nearly threefold; weekly TRx >2,000 .TRx +24% YoY, +13% QoQ; NBRx +200% YoY, +50% QoQ; “one of the fastest growing atypical antipsychotics” .Improving
Ponvory commercializationQ1 2025: specialty neurology build-out; record new patients in April .Q2: QoQ revenue +26%; record new patients; inventory dynamics above historic levels; dispute persists .Improving (steady)
HETLIOZ trajectoryQ3 2024 slight growth but generics; mgmt cautioned variability . Q1: constrained revenue to avoid reversal; warned declines .Q2: -13% YoY; variability and potential significant decline reiterated .Worsening
Pricing/gross-to-net policyQ1: Medicare benefit redesign to pressure gross-to-net in 2025 .Q2: Vasanti Medicaid reset could halve gross-to-net vs Fanapt (25–30% vs ~50%) .Mixed (near-term pressure; future tailwind)
Regulatory pipelineQ1: Bysanti and Tradipitant NDAs accepted; Imsidolimab BLA expected 2025 .Q2: Same milestones; reiterated timelines; Vasanti MDD Phase III ongoing .On track
Legal/regulatoryQ3 2024: pursuing jet lag/insomnia approvals, litigation ongoing .Aug 18, 2025: Appeals court remanded FDA’s denial for jet lag sNDA, requiring meaningful engagement with evidence .Positive external development

Management Commentary

  • “We have witnessed accelerated growth of Fanapt revenue…alongside a broad direct to consumer brand awareness campaign and we expect this trend to continue in the coming quarters.” — Mihael H. Polymeropoulos, CEO .
  • “Fanapt was one of the fastest growing atypical antipsychotics in the market through the first half of 2025 based on prescription metrics.” — Kevin Moran, CFO .
  • “Vasanti…could result in a significant gross‑to‑net favorability…Fanapt gross‑to‑net ~50%, and Vasanti…about half that number at 25%–30%.” — Kevin Moran, CFO .
  • “Revenue is expected to be back‑weighted…Fanapt will grow on a quarterly basis…potentially offset by variability and/or a decline in HETLIOZ revenue.” — Kevin Moran, CFO .

Q&A Highlights

  • Vasanti launch readiness: Management expects minimal incremental commercial spend given Fanapt infrastructure; positioning may be a product switch post-approval .
  • Vasanti NDA pathway: Filed as 505(b)(1) at FDA’s direction because it’s a new molecule; evidence based on bioequivalence PK studies (single and multiple dose, low/high dose) .
  • Ponvory dispute: ~$3M gross‑to‑net variable consideration from 4Q24 remains in dispute; management guided to steady growth as relationships/hub processing build .
  • Tradipitant motion sickness: Review ongoing; earliest market entry Jan 1, 2026 if approved Dec 30, 2025; expanded access ongoing with strong patient stories .

Estimates Context

  • Q2 2025: Revenue missed ($52.6M vs $54.8M*) and EPS missed (-$0.46 vs -$0.36*), reflecting elevated SG&A/R&D and HETLIOZ pressure despite Fanapt strength . Values retrieved from S&P Global.
  • Q1 2025 context: Revenue beat ($50.0M vs $45.1M*), EPS beat (-$0.50 vs -$0.60*), aided by Fanapt growth; however, opex step-up reduced profitability . Values retrieved from S&P Global.
  • Implication: Consensus may need to lower near-term EPS on higher opex and HETLIOZ variability, while raising out‑quarters for Fanapt ramp and potential Vasanti gross‑to‑net reset upon approval .

Key Takeaways for Investors

  • Fanapt is the growth engine; prescriptions and new starts point to accelerating trajectory into 2H, supporting back‑weighted revenue despite Q2 miss vs consensus .
  • Near‑term EPS pressure likely persists as SG&A and R&D investments continue; watch for operating leverage as Fanapt revenue scales .
  • HETLIOZ remains a drag with generic competition and inventory normalization; model additional variability/decline risk .
  • Ponvory is building steadily; expect measured growth as neurology coverage and hub processes mature; pricing/deductions remain a watch item .
  • Regulatory catalysts: Tradipitant (Dec 30, 2025 PDUFA), Bysanti (Feb 21, 2026 PDUFA), Imsidolimab BLA submission in 2025; Vasanti Medicaid reset could materially improve net revenue capture upon launch .
  • Legal upside optionality: Appeals court remand on HETLIOZ jet lag sNDA increases probability of approval or hearing; potential revenue diversification if successful .
  • Trading lens: Balance Fanapt momentum and pipeline optionality vs near‑term opex intensity and HETLIOZ headwinds; catalysts into 4Q25–1Q26 could re-rate stock on regulatory outcomes .