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Travere Therapeutics, Inc. (TVTX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $81.73M, a clear beat versus Wall Street consensus of $76.86M; non-GAAP EPS of $(0.19) beat consensus $(0.39), while GAAP EPS was $(0.47). Strength was driven by FILSPARI net sales and license/collaboration revenue from CSL Vifor’s EU launch . Consensus values retrieved from S&P Global.*
  • FILSPARI U.S. net product sales reached $55.9M, up 13% sequentially and 182% year-over-year; 703 new patient start forms (PSFs) sustained demand following full approval and broadened label .
  • EU and UK converted FILSPARI to full approval in April, triggering an expected $17.5M milestone payment in Q2 and strengthening ex-U.S. access via CSL Vifor .
  • Management highlighted higher 2025 gross-to-net (low 20s, stickier due to Part D redesign) but reiterated demand durability, payer access improvements, and maintained confidence in growth trajectory .
  • Regulatory catalyst: FSGS sNDA submitted in March with expected FDA acceptance notice in May; potential priority review and launch as early as September if approved .

What Went Well and What Went Wrong

What Went Well

  • FILSPARI commercial momentum: $55.9M net sales, +13% q/q; “March being our strongest month since launch” with April continuing the trend .
  • Demand broadening and earlier intervention: 703 PSFs; physicians targeting lower proteinuria consistent with KDIGO draft; “nephrologists…prescribing FILSPARI earlier…to lower targeted proteinuria thresholds” .
  • Ex-U.S. approvals enabling milestones and access: EU and UK conversions to standard approvals; “expect to receive a $17.5 million milestone…in Q2 2025” .

Specific quotes:

  • “Net sales of FILSPARI grew 182% year-over-year and 13% versus the prior quarter” .
  • “Our latest market research shows that approximately 75% of nephrologists are now targeting proteinuria below 0.5 g/g” .
  • “We expect to receive a $17.5 million milestone payment from CSL Vifor…in the second quarter” .

What Went Wrong

  • Continued losses despite revenue growth: GAAP net loss $(41.23)M; GAAP EPS $(0.47), reflecting higher SG&A investment post full approval .
  • Gross-to-net headwinds: 2025 GtN guided to low 20s versus mid-to-high teens last year; stickier impact from Part D redesign throughout the year .
  • Tiopronin pressure: management “anticipate more generic competition…in the coming quarters,” implying incremental headwinds within legacy products .

Financial Results

Consolidated Revenue and EPS (GAAP and non-GAAP)

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$62.90 $74.79 $81.73
GAAP Net Loss ($USD Millions)$(54.81) $(60.26) $(41.23)
GAAP EPS ($USD)$(0.70) $(0.73) $(0.47)
Non-GAAP Net Loss ($USD Millions)$(35.63) $(39.03) $(16.89)
Non-GAAP EPS ($USD)$(0.46) $(0.47) $(0.19)

Actual vs Wall Street Consensus (S&P Global) – Q3 2024 to Q1 2025

MetricQ3 2024Q4 2024Q1 2025
Revenue Actual ($USD Millions)$62.90 $74.79 $81.73
Revenue Consensus ($USD Millions)$60.83*$72.38*$76.86*
Primary EPS Actual ($USD)$(0.46)*$(0.47)*$(0.19)*
Primary EPS Consensus ($USD)$(0.54)*$(0.38)*$(0.39)*

Values retrieved from S&P Global.*

Margin Trends

Margin MetricQ3 2024Q4 2024Q1 2025
Operating Margin %(Operating Loss $56.15M / Revenue $62.90M) = −89.3% (Operating Loss $60.74M / Revenue $74.79M) = −81.2% (Operating Loss $42.67M / Revenue $81.73M) = −52.2%
Net Income Margin %(Net Loss $54.81M / Revenue $62.90M) = −87.1% (Net Loss $60.26M / Revenue $74.79M) = −80.6% (Net Loss $41.23M / Revenue $81.73M) = −50.5%

Segment and Revenue Mix – Q1 2025

ComponentQ1 2025
FILSPARI Net Product Sales (U.S.) ($USD Millions)$55.88
Tiopronin Products ($USD Millions)$19.98
License & Collaboration Revenue ($USD Millions)$5.87
Total Revenue ($USD Millions)$81.73

Commercial KPIs – Q1 2025

KPIQ1 2025
New PSFs703
FILSPARI U.S. Net Product Sales YoY Growth+182%
Sequential FILSPARI Sales Growth+13%
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$322.2
Expected EU Milestone – Q2 2025 ($USD Millions)$17.5

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Gross-to-Net (FILSPARI)FY 2025Mid-to-high teens (2024 baseline) Low 20s; highest in Q1; “stickier” due to Part D redesign Raised discounts
REMS (Liver Monitoring Frequency)Aug 28, 2025 PDUFAsNDA filed; PDUFA Aug 28, 2025 Continues to expect PDUFA Aug 28, 2025 Maintained timeline
REMS (Embryo-Fetal Monitoring)2025 amendment—FDA notified embryo-fetal REMS is no longer necessary; amendment planned to remove monitoring (part of REMS sNDA) Easing requirements
FSGS sNDA Status2025On track to submit around end of Q1 2025 sNDA submitted (March); FDA acceptance notice expected in May; potential priority review Advanced to review
EU/UK FILSPARI ApprovalQ2 2025 milestoneCMA to full approval anticipated Converted to standard approval; $17.5M milestone expected in Q2 Achieved & monetizing

Earnings Call Themes & Trends

TopicQ3 2024 (Prior-2)Q4 2024 (Prior-1)Q1 2025 (Current)Trend
FILSPARI foundational positioningFull approval; education on 2-year kidney preservation; draft KDIGO push for earlier, lower targets Strong demand inflection; broadened label, payer adoption Sustained momentum; majority prescribers targeting <0.5 g/g; strong compliance/persistence Strengthening utilization and earlier use
REMS modificationsNDA to quarterly liver monitoring; safety package pooled (no Hy’s law) PDUFA Aug 28, 2025; two-step plan to modify then remove On track; embryo-fetal monitoring removal planned via amendment Easing compliance burden
FSGS regulatory pathPARASOL outcome supports proteinuria as surrogate; planning Type C On track to sNDA in Q1 2025 sNDA submitted; acceptance expected May; potential priority review Advancing toward approval
Competitive dynamics (IgAN)Early combination positioning; data with SGLT2/steroids Discussion of Novartis/atrasentan; confidence in dual-pathway efficacy & convenience April demand continued despite atrasentan launch; reps see confidence in FILSPARI Resilient vs new entrants
Payer access & GTNExpansion of coverage post full approval; removal of thresholds GTN high teens/low 20s guided Low 20s with Part D stickiness; broad coverage maintained Manageable headwind
Ex-U.S. expansionLaunches in DE/AT/CH Anticipated EU conversion and milestones in 2025 EU/UK full approvals; milestone expected in Q2 Executing on EU rollout
R&D execution (SPARTAN/DUPLEX/DUET)SPARTAN: ~70% proteinuria reduction; anti-inflammatory signals Continued evidence generation NKF: remission earlier and more frequent; ~50% u-sCD163 reduction; expanded studies Clinical evidence broadening

Management Commentary

  • “FILSPARI remains uniquely positioned as the only fully approved non-immunosuppressive kidney-targeted therapy that has shown superiority over the historical standard of care” (Eric Dube) .
  • “Treatment with FILSPARI resulted in approximately 70% proteinuria reduction…nearly 60% achieved complete remission” (Jula Inrig, SPARTAN data) .
  • “We received 703 new patient start forms in the first quarter…March being our strongest month since launch, and demand in April continued this trend” (Peter Heerma) .
  • “Gross to nets…in the low 20s…with Part D redesign…stickier than last year” (Chris Cline) .

Q&A Highlights

  • FSGS sNDA review: Interactions consistent with IgAN; FDA feedback supportive of proteinuria as approval endpoint; potential indication to include ages 8+ across FSGS subtypes (primary, genetic) .
  • Competitive landscape: Early atrasentan launch did not dent April demand; FILSPARI’s long-term kidney preservation and convenience underpin prescriber confidence .
  • GTN and payer dynamics: Highest discounts in Q1; more even across the year; payer criteria easing post full approval with removal of proteinuria thresholds in multiple plans .
  • PSF cadence sustainability: Chronic treatment, strong compliance/persistence supports revenue durability; PSFs sourcing increasingly from patients below 1.5 g/g .
  • FSGS launch readiness: Overlap with IgAN prescribers >80%; pricing value justified by dose and unmet need; expectation of rapid uptake if approved .

Estimates Context

  • Q1 2025 delivered a revenue and EPS beat: Revenue $81.73M vs $76.86M consensus; Primary EPS $(0.19) vs $(0.39) consensus, reflecting stronger demand and license/collaboration revenue from CSL Vifor’s EU launch . Consensus values retrieved from S&P Global.*
  • With GTN a headwind, estimate models may need to raise FILSPARI quarterly sales run-rate assumptions and incorporate EU milestone timing in Q2, offsetting GTN impacts .

Q1 2025 Actual vs Consensus Detail

MetricActualConsensusSurprise
Revenue ($USD Millions)$81.73 $76.86*+$4.87
Primary EPS ($USD)$(0.19)*$(0.39)*+$0.20

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • FILSPARI’s U.S. growth is accelerating post full approval; sequential momentum and PSF strength suggest durable trend even amid new competitive entries—supporting near-term revenue upside .
  • Near-term catalysts: EU/UK approvals monetized via $17.5M Q2 milestone; FSGS sNDA acceptance in May; potential priority review with launch as early as September—material stock catalysts .
  • Estimate revisions likely higher for FILSPARI sales and lower for normalized EPS given operating leverage and milestone contribution, despite GTN running in the low 20s .
  • Risk management: GTN and generic Tiopronin pressure persist; monitor payer criteria changes and competitive detailing as atrasentan uptake evolves .
  • Strategic positioning: Dual pathway inhibition, long-term kidney preservation, and broadened IgAN label reinforce FILSPARI as foundational therapy—creating a defensible moat versus single-pathway competitors .
  • Ex-U.S. optionality: CSL Vifor ramp in Europe plus Renalys Japan Phase 3 data in 2H 2025 extend the global opportunity; milestone and OUS sales provide incremental buffers .
  • Trading lens: Into Q2, watch for milestone receipt, continued PSF momentum, and any FSGS review updates; a positive FDA acceptance and priority review designation could re-rate the name on potential first-to-market FSGS approval .