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Vanda Pharmaceuticals Inc. (VNDA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue beat consensus by ~11% as Fanapt growth offset PONVORY softness and HETLIOZ variability; operating loss widened on commercial build-out and a $15M imsidolimab license payment, driving a net loss of $29.5M . Revenue: $50.0M vs S&P Global $45.1M*; EPS: -$0.50 vs -$0.60* (beat) .
  • Management reiterated 2025 total revenue guidance of $210–$250M and added year-end cash guidance of $280–$320M, noting back-half weighting from Fanapt and PONVORY ramps and Medicare benefit redesign pressure on gross-to-net .
  • Commercial KPIs inflected: Fanapt TRx +14% YoY; NBRx nearly tripled; weekly TRx surpassed 2,000 in late April; psychiatry sales force expanding to ~300; PONVORY new patient prescriptions reached a record in April .
  • Near-term regulatory catalysts: Bysanti NDA accepted (PDUFA Feb 21, 2026); tradipitant NDA for motion sickness accepted (PDUFA Dec 30, 2025); imsidolimab BLA for GPP expected 2025; EMA MAAs pending for Fanapt and HETLIOZ LQ .

What Went Well and What Went Wrong

What Went Well

  • Fanapt momentum: “weekly prescriptions surpassing 2,000 at the end of April,” with TRx +14% YoY and NBRx nearly tripled; sales force scaling to ~300 reps .
  • Revenue beat and guidance maintained: Q1 revenue $50.0M beat S&P Global consensus $45.1M*; 2025 revenue guide reiterated at $210–$250M; cash guidance introduced at $280–$320M .
  • Pipeline/regulatory progress: Bysanti NDA accepted with 2/21/26 PDUFA; tradipitant (motion sickness) accepted with 12/30/25 PDUFA; imsidolimab license closed with BLA planned in 2025 .

What Went Wrong

  • Profitability deterioration: Operating loss widened to -$41.0M (op margin ~-82%) on higher SG&A for launches and $15M imsidolimab payment in R&D; net loss -$29.5M (net margin ~-59%) .
  • HETLIOZ variability and downside risk: mix- and inventory-driven variability; potential significant future declines amid ongoing generic competition and variable consideration constraints .
  • PONVORY YoY down: Q1 sales $5.6M (-18% YoY) on lower volume; though April new patient prescriptions hit record, ramp remains early .

Financial Results

Headline P&L vs prior quarters and estimates

MetricQ3 2024Q4 2024Q1 2025
Revenue ($M)$47.7 $53.2 $50.0
Diluted EPS ($)-0.09 -0.08 -0.50
Loss from Operations ($M)-$11.0 -$10.3 -$41.0
Operating Margin (%)-23.1% (calc from )-19.3% (calc from )-82.0% (calc from )
Net Income (Loss) ($M)-$5.3 -$4.9 -$29.5
Net Margin (%)-11.2% (calc from )-9.2% (calc from )-59.0% (calc from )

Performance vs S&P Global consensus

MetricQ3 2024Q4 2024Q1 2025
Revenue Actual ($M)$47.7 $53.2 $50.0
Revenue Consensus ($M)$49.2*$52.3*$45.1*
Rev Beat/(Miss)-$1.5M (-3.1%)*+$0.9M (+1.8%)*+$4.9M (+10.9%)*
EPS Actual ($)-0.09 -0.08 -0.50
EPS Consensus ($)-0.16*-0.11*-0.60*
EPS Beat/(Miss)+$0.07*+$0.03*+$0.10*

Note: *Values retrieved from S&P Global.

Segment/product revenue ($M)

ProductQ3 2024Q4 2024Q1 2025
Fanapt$23.9 $26.6 $23.5
HETLIOZ$17.9 $20.0 $20.9
PONVORY$5.9 $6.5 $5.6
Total$47.7 $53.2 $50.0

KPIs and Operating Drivers

KPIQ3 2024Q4 2024Q1 2025 / Early Q2
Fanapt TRx YoY+90% NBRx; TRx rising (lead indicator) NBRx +160% YoY; TRx +7% QoQ TRx +14% YoY; weekly TRx >2,000 (wk of Apr 25)
Fanapt NBRx YoY>+90% >+160% Nearly 3x
Sales force (Psychiatry)~150 reps >200; targeting 300 ~250 now; expanding to ~300
PONVORY new patientsLaunch initiated; destocking impacted Q3 +11% QoQ; distribution normalized Record new patient Rx in April; SF to ~40
HETLIOZ dynamicsDurability; EMA MAA pending Variability; elevated inventories Retains largest share; variability persists

Guidance Changes

MetricPeriodPrevious Guidance (as of Q4 2024)Current Guidance (Q1 2025)Change
Total RevenuesFY 2025$210–$250M $210–$250M Maintained
Year-end CashFY 2025Not provided $280–$320M Introduced
CommentaryFY 2025IRA Medicare redesign headwind to gross-to-net; back-half weighting expected Same themes reiterated; back-half growth from Fanapt/PONVORY, HETLIOZ variability risk Emphasized

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Fanapt commercializationLaunch build-out; NBRx >+90%; sales force to 200 TRx +14% YoY; NBRx ~3x; weekly TRx >2,000; DTC running; SF to ~300 Accelerating
HETLIOZ outlookDurability but destocking; generics pressure Largest market share; variability; potential declines Cautious/Variable
PONVORY rampLaunch; destocking resolved; build SF ~30 April new Rx record; SF to ~40; exploring UC/psoriasis Improving
IRA/Medicare impactWarned for 2025 Gross-to-net headwind emphasized Ongoing headwind
Bysanti (milsaperidone)NDA targeted early 2025; MDD Ph3 plan NDA accepted; PDUFA 2/21/26; MDD Ph3 ongoing De-risking
Fanapt LAIPivotal plan; study design alignment with FDA IRB pushback on placebo; exploring alternatives; timing likely 2027 data Path being adjusted
TradipitantGastroparesis CRL; motion sickness NDA planned Motion sickness NDA accepted; PDUFA 12/30/25; gastroparesis hearing delayed Mixed (MS progress; GP legal)
Imsidolimab (GPP)N/ALicensed; BLA planned 2025 New growth vector

Management Commentary

  • “Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April” — CEO Mihael Polymeropoulos .
  • “The implementation of the [Medicare] benefit redesign is expected to negatively impact gross to net… more significantly on Fanapt and HETLIOZ” — CFO Kevin Moran .
  • On DTC: “Direct-to-consumer awareness campaigns are fruitful” in bipolar disorder; campaigns running for Fanapt and PONVORY .
  • On HETLIOZ: “Net product sales may decline in future periods, potentially significantly, related to continued generic competition” .
  • On pipeline breadth: “Vanda could have 6 products commercially available in 2026” (Fanapt, HETLIOZ, PONVORY, tradipitant, Bysanti, imsidolimab) .

Q&A Highlights

  • DTC ROI and scope: Management launched DTC for bipolar and PONVORY; measured, ROI-driven spend; early feedback positive .
  • Bysanti bioequivalence dataset: Two crossover bioequivalence studies (single and multiple dose) underpinning NDA; data presented at ASCP .
  • EMA filings: D120 questions received; focus initially on Germany for reimbursement dynamics .
  • Fanapt LAI design: IRB objections to placebo-controlled relapse prevention; working with FDA on alternative design/bridging; 2027 timing for results discussed .
  • Payer dynamics: Medicare redesign quantified qualitatively as headwind to gross-to-net; mix effects by product explained .

Estimates Context

  • Q1 2025 beat S&P Global on both revenue and EPS: $50.0M vs $45.1M*, and -$0.50 vs -$0.60*, driven by Fanapt prescription growth and NBRx acceleration; SG&A and R&D investment widened losses as expected .
  • Prior quarters show consistent EPS outperformance and mixed revenue performance (Q4 beat; Q3 miss), suggesting sell-side underappreciated Fanapt trajectory and launch timing variability .
  • Implications: Street models likely raise 2025 revenue within the guide, shift revenue to back half, lower HETLIOZ contribution, and carry higher SG&A for commercial expansion; GAAP EPS likely trimmed near term on opex.
    Note: *Values retrieved from S&P Global.

Key Takeaways for Investors

  • Fanapt momentum is the core driver; KPIs (TRx/NBRx, weekly TRx >2,000) support sustained growth as sales force ramps and DTC scales .
  • 2025 is back-half weighted; model IRA gross-to-net pressure and HETLIOZ variability, offset by Fanapt ramp and early PONVORY traction .
  • Regulatory catalysts stack through 2025–2026: tradipitant (12/30/25), Bysanti (2/21/26), imsidolimab BLA 2025—each a potential re-rating event .
  • Expense intensity remains elevated near term (commercial build + pipeline), keeping GAAP losses high; watch for operating leverage into 2H25 as Fanapt grows .
  • HETLIOZ remains a risk factor (generic erosion, inventory normalization); treat upside as optionality rather than base case .
  • Stock reaction catalysts: continued Fanapt TRx/NBRx cadence, DTC efficacy, PONVORY new patient trends, clarity on LAI study design, and any visibility on tradipitant hearing/gastroparesis .
  • Valuation sensitivity likely shifts toward psychiatry portfolio optionality (Bysanti/MDD, Fanapt LAI) versus legacy assets; monitor EMA outcomes and pricing dynamics .

Appendix: Additional Detail

  • Q1 2025 cash/marketable securities: $340.9M; sequential decrease reflects $15M imsidolimab license payment .
  • Product details: Fanapt sales $23.5M (+14% YoY), HETLIOZ $20.9M (+4% YoY), PONVORY $5.6M (-18% YoY) .
  • Non-recurring/adjustments: HETLIOZ revenue constrained for variable consideration; PONVORY prior-quarter variable consideration noted; these may cause period-to-period variability .