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Travere Therapeutics, Inc. (TVTX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered record revenue of $114.4M and non-GAAP EPS of $0.13, driven by FILSPARI momentum and a $17.5M CSL Vifor milestone; GAAP EPS was -$0.14 .
  • FILSPARI U.S. net product sales reached $71.9M (+165% YoY) with 745 new PSFs; U.S. net product sales for total products were $94.8M .
  • Post-quarter, FDA approved REMS modifications for FILSPARI (quarterly LFTs; removal of embryo‑fetal monitoring), a tangible access catalyst; FSGS sNDA accepted with PDUFA Jan 13, 2026 and an AdCom planned .
  • Consensus was handily beaten on revenue and EPS; EBITDA missed versus consensus (likely mix of milestone and operating leverage), setting up estimate revisions focused on sustained top-line trajectory and margin normalization (see Estimates Context).

What Went Well and What Went Wrong

What Went Well

  • FILSPARI commercial execution: “This quarter marked our strongest commercial performance to date, with increased momentum for FILSPARI…” — Eric Dube, CEO .
  • Robust demand KPIs: 745 new PSFs (+~43% YoY) reflecting expanding prescriber base and earlier use in treatment journey .
  • Ex-U.S. progress and monetization: EU/UK full approvals triggered $17.5M milestone; Renalys Japan Phase 3 topline expected 2H 2025 .

What Went Wrong

  • SG&A inflation: GAAP SG&A $76.2M (+$11.4M YoY) reflecting higher amortization of royalties and launch prep for FSGS, pressuring operating margins .
  • Tiopronin softness and generic risk: Tiopronin net product sales fell YoY to $23.0M in Q2; management anticipates more generic competition near term .
  • EBITDA below consensus: EBITDA actual of $1.37M* vs $3.13M* consensus, indicating operating cost intensity and milestone accounting dynamics weighed on near-term profitability*.

Financial Results

Quarterly Trend vs Prior Quarters

MetricQ4 2024Q1 2025Q2 2025
Total Revenue ($USD Millions)$74.787 $81.732 $114.449
GAAP EPS ($USD)-$0.73 -$0.47 -$0.14
Non-GAAP EPS ($USD)-$0.47 -$0.19 $0.13
Gross Margin %96.6% (Rev, COGS) 94.3% (Rev, COGS) 98.7% (Rev, COGS)
Operating Income ($USD Millions)-$60.737 -$42.674 -$12.650
EBIT Margin %-81.2% (Op/Rev) -52.2% (Op/Rev) -11.1% (Op/Rev)

Note: Gross Margin % calculated as (Revenue − COGS) / Revenue; EBIT Margin % calculated as Operating Income / Revenue (sources cited per components).

Year-over-Year Comparison (Q2 2024 vs Q2 2025)

MetricQ2 2024Q2 2025
Total Revenue ($USD Millions)$54.116 $114.449
Total Net Product Sales ($USD Millions)$52.176 $94.842
GAAP EPS ($USD)-$0.91 -$0.14
Non-GAAP EPS ($USD)-$0.65 $0.13
FILSPARI U.S. Net Product Sales ($USD Millions)$27.125 $71.887

Product and Revenue Mix by Quarter

MetricQ4 2024Q1 2025Q2 2025
FILSPARI Net Product Sales ($USD Millions)$49.644 $55.881 $71.887
Tiopronin Products Net Product Sales ($USD Millions)$23.902 $19.980 $22.955
License & Collaboration Revenue ($USD Millions)$1.241 $5.871 $19.607

KPIs

KPIQ4 2024Q1 2025Q2 2025
New Patient Start Forms (PSFs)693 703 745
FILSPARI U.S. Net Product Sales ($USD Millions)$49.6 $55.9 $71.9
Gross-to-Net CommentaryN/AEarly-year dynamics elevated “Low 20%” maintained for FY (CFO)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FILSPARI REMS monitoring frequency & EFT monitoringIgAN Label (Post-Q2)Monthly LFTs; embryo-fetal toxicity monitoring required Quarterly LFTs; EFT monitoring removed (FDA approval 8/27/25) Eased (access catalyst)
Gross-to-Net Discount (FILSPARI)FY 2025“Low 20%” implied/maintained “Low 20%” reiterated Maintained
FSGS sNDA/TimelineFSGSSubmission in Q1; acceptance awaited sNDA accepted; PDUFA 1/13/2026; AdCom planned Timeline set
Revenue, Margin, OpEx, OI&E, Tax RateFY 2025Not providedNot providedN/A

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
FILSPARI commercial performanceQ4: $49.6M FILSPARI; 693 PSFs; full approval reinforcing adoption Record U.S. FILSPARI $71.9M; 745 PSFs; earlier use; high persistence; no stocking Strengthening
Regulatory/legal (REMS and FSGS)Plan to submit FSGS sNDA; IgAN REMS modification PDUFA 8/28/25 sNDA accepted; AdCom expected Q4; Jan 13, 2026 PDUFA Advancing
R&D execution (SPARTAN/PROTECT/DUPLEX)NKF data: ~70% proteinuria reduction; disease-modifying biomarker signals ERA/IPC data reinforce nephroprotection; remission linked to lower kidney failure risk Reinforcing
Ex‑U.S. expansionEU/UK full approvals anticipated; CSL launches DACH markets EU/UK full approvals achieved; $17.5M milestone received Monetizing
Gross-to-net dynamicsQ1: early-year pressure easing “Low 20%” for FY; some 2H discount variability Normalizing
Competition & market growthExpect broader treatment options to expand market urgency Confident FILSPARI remains foundational amid new entrants; endothelin market grows Expanding

Management Commentary

  • “This quarter marked our strongest commercial performance to date, with increased momentum for FILSPARI resulting in significant growth in a dynamic IgAN market.” — Eric Dube, CEO .
  • “VILSPARI’s unique ability to target two pathways… provides patients with IgA nephropathy a non‑immunosuppressive treatment option to help preserve kidney function.” — Jula Inrig, CMO .
  • “FILSPARI net product sales reached approximately $72 million in the U.S. in the second quarter… driven by strong demand… and solid therapy compliance and persistence.” — Peter Heerma, CCO .
  • “Net loss for the second quarter was $12.8 million… On a non‑GAAP adjusted basis, net income for the second quarter was $11.9 million.” — Chris Cline, CFO .

Q&A Highlights

  • FSGS AdCom scope: Team will educate panel on proteinuria as validated surrogate; DUPLEX/DUET evidence and Parasol analyses support approval framework .
  • REMS path: Two-step approach; FDA historically anchored to PMR 3,000 patients/2 years; dialogue ongoing for full removal following quarterly LFT modification .
  • Demand sustainability and competition: Highest-ever quarter; fundamentals strong; endothelin market likely expands; FILSPARI positioned as market leader .
  • eGFR in FSGS: Not a focus given proteinuria surrogate; curves show expected acute decline then relative stability .
  • Ex-U.S. royalties: Ramp as CSL secures reimbursement market-by-market; milestone already realized .

Estimates Context

MetricQ2 2025 ConsensusQ2 2025 ActualResult
Revenue ($USD Millions)$100.175*$114.449 Beat
Primary/Normalized EPS ($USD)$0.04*$0.13 (non-GAAP) Beat
EBITDA ($USD Millions)$3.128*$1.367*Miss
Primary EPS - # of Estimates5*N/A—
Revenue - # of Estimates14*N/A—
Target Price Consensus Mean ($USD)$41.5*$41.5*—

Values with asterisks (*) retrieved from S&P Global.

Implications: The top-line and EPS beats underscore stronger-than-modeled FILSPARI uptake and milestone contribution; the EBITDA miss suggests operating expense intensity and mix effects. Expect upward revisions to revenue/EPS trajectories and scrutiny on SG&A leverage beyond 2025.

Key Takeaways for Investors

  • FILSPARI adoption is accelerating with earlier-line use and rising PSFs, producing sequential revenue step-ups and near-break-even GAAP operating performance trajectory .
  • Post-quarter REMS simplification (quarterly LFTs; EFT monitoring removed) is a clear access tailwind likely to deepen use in lower-proteinuria segments and streamline clinic workflows .
  • FSGS PDUFA in January and an expected Q4 AdCom represent binary catalysts; management prepared to defend proteinuria as validated surrogate with DUPLEX/DUET data and Parasol precedent .
  • Ex-U.S. monetization has commenced (EU/UK full approvals; $17.5M milestone), with royalties to ramp as reimbursement spreads — a diversification lever .
  • Watch SG&A intensity and Tiopronin erosion from generics; sustained gross-to-net in “low 20%” supports margin normalization as volume scales .
  • Consensus beats on revenue/EPS set positive estimate momentum; focus shifts to durability of demand, persistence, and ability to convert PSFs at the “top-end best practice” rare disease benchmark .
  • Near-term trading: positive REMS and beat/raise narrative; medium-term thesis hinges on foundational positioning in IgAN and first-to-approve potential in FSGS.