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Travere Therapeutics, Inc. (TVTX)·Q3 2025 Earnings Summary

Executive Summary

  • Travere delivered a standout quarter: total revenue $164.9M (+162% Y/Y) on FILSPARI U.S. sales of $90.9M (+155% Y/Y) and $51.7M licensing revenue; non-GAAP EPS $0.59 vs S&P Global consensus -$0.09, a major beat driven by continued FILSPARI momentum and a $40M EU market-access milestone .
  • Operating leverage inflected: GAAP operating income $24.9M and net income $25.7M (GAAP EPS $0.29); non-GAAP net income $52.8M (EPS $0.59), reflecting strong gross-to-net execution and disciplined opex despite launch prep for FSGS .
  • Structural tailwinds strengthened: FDA streamlined REMS (quarterly LFTs, removed embryo-fetal monitoring), and 2025 KDIGO guidelines position FILSPARI as foundational first-line therapy in IgAN, supporting earlier use and broader adoption .
  • 2026 catalysts: FDA canceled planned AdCom; FSGS sNDA has a January 13, 2026 PDUFA. Management is preparing for a rapid launch upon approval; new DUPLEX/RaDaR data at ASN reinforce proteinuria thresholds linked to 5-year kidney failure risk reduction, supporting the FSGS case .

What Went Well and What Went Wrong

What Went Well

  • Commercial momentum: FILSPARI U.S. sales $90.9M (+155% Y/Y); 731 PSFs despite summer seasonality, with the strongest daily PSF rate in September continuing into October .
  • Quality of beat: Non-GAAP EPS $0.59 vs S&P Global consensus -$0.09*; revenue $164.9M vs $106.1M* consensus, supported by a $40M market-access milestone and improved pull-through, compliance, and persistence .
  • Strategic tailwinds: FDA REMS simplification and KDIGO guidelines elevate FILSPARI as foundational, enabling earlier treatment and easier monitoring; management calls it a “paradigm shift” among nephrologists .

What Went Wrong

  • PSFs dipped sequentially (745 in Q2 → 731 in Q3), attributed to seasonality; management flagged higher gross-to-net in Q4 (~20% FY) which could temper near-term flow-through .
  • SG&A rose to $86.5M (vs $65.6M Y/Y) as the company invests ahead of potential FSGS launch; further increases expected into Q4 and launch .
  • Cash declined to $254.5M at 9/30 (excludes $40M milestone received in Oct) due to retiring the remaining ~$69M 2025 converts; reduces flexibility near-term until milestone receipts are recognized in cash .

Financial Results

P&L and EPS vs prior periods

MetricQ1 2025Q2 2025Q3 2025
Total Revenue ($M)$81.7 $114.4 $164.9
U.S. Net Product Sales ($M)$75.9 $94.8 $113.2
FILSPARI U.S. Sales ($M)$55.9 $71.9 $90.9
Tiopronin Products ($M)$20.0 $23.0 $22.3
License & Collaboration Rev. ($M)$5.9 $19.6 $51.7
GAAP EPS (Basic)$(0.47) $(0.14) $0.29
Non-GAAP EPS$(0.19) $0.13 $0.59
EBIT Margin %(52.2%)*(11.1%)*15.1%*
EBITDA Margin %(36.5%)*1.2%*24.7%*
Net Income Margin %(50.4%)*(11.1%)*15.6%*

Notes: Margins marked * are from S&P Global (GetFinancials). Values retrieved from S&P Global.

Q3 2025 actuals vs S&P Global consensus

MetricConsensusActualDelta
Total Revenue ($M)$106.1*$164.9 +$58.8 (+55%)
Primary EPS (Adj)$(0.09)*$0.59 +$0.68
EBITDA ($M)$10.8*$40.7*+$29.9

Notes: Consensus/EBITDA marked * from S&P Global. Values retrieved from S&P Global.

Segment/Product and Revenue Mix Detail

Revenue Component ($M)Q1 2025Q2 2025Q3 2025
FILSPARI U.S. Sales$55.9 $71.9 $90.9
Tiopronin Products$20.0 $23.0 $22.3
License & Collaboration$5.9 $19.6 $51.7
Total Revenue$81.7 $114.4 $164.9

KPI – Patient Start Forms (PSFs)

KPIQ1 2025Q2 2025Q3 2025
New PSFs703 745 731

Balance Sheet Liquidity

MetricQ1 2025 (3/31)Q2 2025 (6/30)Q3 2025 (9/30)
Cash, Cash Eq., Mkt. Sec. ($M)$322.2 $319.5 $254.5 (excl. $40M milestone received Oct)

Drivers/Context:

  • Q3 includes a $40M EU market-access milestone and $9.3M non-cash license revenue related to Renalys; $40M was received in October (cash not in 9/30 balance) .
  • CFO noted < $2M one-time FILSPARI gross-to-net benefit in Q3 and reiterated higher Q4 GTN; FY25 GTN around 20% .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FSGS sNDA status1Q26PDUFA Jan 13, 2026; AdCom planned (Q2) PDUFA Jan 13, 2026; FDA no longer needs AdCom (Sept) Improved regulatory visibility
SG&A (Launch Prep)2H25–LaunchInvesting for FSGS; incremental ramp expected Incremental SG&A in Q4; higher at launch to ensure strong start Raised
Gross-to-Net (FILSPARI)FY25Back half higher GTN; ~20% FY Reiterated: Q4 higher; ~20% FY Maintained
Liquidity/Capital needsNear-termNot specified“No near-term need for additional capital” Clarified
FILSPARI REMSAug-2025Monthly LFTs + EFT REMS Quarterly LFTs; EFT REMS removed Eased monitoring

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Regulatory (REMS/KDIGO)Anticipated REMS change; expected KDIGO final in 2H25 FDA REMS streamlined; KDIGO final guidelines elevate FILSPARI to foundational/first-line IgAN Positive structural tailwind
Product performance (IgAN)FILSPARI momentum; Q2 U.S. $71.9M; PSFs 745 FILSPARI U.S. $90.9M; PSFs 731; September daily PSF peak; strong pull-through and persistence Continued growth; slightly lower PSFs Q/Q due to seasonality
Competitive landscapeLaunches not disrupting trajectory Demand “very consistent”; little competitive impact; broader uptake at lower proteinuria Stable/constructive
FSGS pathwaysNDA accepted; AdCom planned AdCom canceled; PDUFA 1/13/26; ASN DUPLEX/RaDaR data support clinical relevance of proteinuria thresholds Improved visibility; data reinforcement
R&D execution (Pegtibatinase)On track to restart in 2026 First commercial-scale batches completed; restart expected 2026 Operational progress
Commercial economicsGTN commentary emerging with Part D true-ups < $2M one-time GTN Q3; Q4 GTN higher; ~20% FY; improved pull-through More clarity on durability

Management Commentary

  • “We delivered outstanding commercial performance… reflecting the growing role of FILSPARI as a foundational therapy in IgAN.” – Eric Dube, CEO .
  • “KDIGO… includes FILSPARI as a first-line option… the only therapy with proven efficacy versus optimized RAS inhibition… nephrologists describe the new KDIGO framework as a true paradigm shift.” – Jula Inrig, CMO .
  • “FILSPARI net sales reached approximately $91M… 731 PSFs… September recorded our highest daily PSF rate since launch… demand remains robust.” – Peter Heerma, CCO .
  • “We repaid our remaining 2025 convertible notes… total revenue of $164.9M… non-GAAP EPS $0.59… no near-term need for additional capital.” – Chris Cline, CFO .

Q&A Highlights

  • REMS/KDIGO impact: Management sees REMS simplification and KDIGO publication as tailwinds broadening eligible patients (especially lower-proteinuria) and easing monitoring burden; awareness is spreading beyond KOLs to community nephrologists .
  • Competitive dynamics: Demand “very consistent” despite new entrants; FILSPARI preferred for proteinuria efficacy and once-daily oral regimen; continued penetration in patients <1.5 g/g UPCR .
  • PSFs and GTN: Sequential PSF dip attributed to seasonality; September/October trends strong; < $2M one-time GTN benefit in Q3; Q4 GTN higher; FY ~20% .
  • FSGS communication: Company will enter a quiet period approaching PDUFA; no labeling updates expected pre-decision .
  • SG&A outlook: Incremental investment in Q4 and around potential FSGS launch; leveraging overlapping prescriber base .

Estimates Context

  • Q3 2025 delivered a decisive beat: revenue $164.9M vs $106.1M consensus*; Primary EPS (non-GAAP) $0.59 vs -$0.09 consensus*; EBITDA $40.7M* vs $10.8M* consensus .
  • Prior quarters:
    • Q2 2025: revenue $114.4M vs $100.2M*; EPS $0.13 vs $0.04* .
    • Q1 2025: revenue $81.7M vs $76.9M*; EPS $(0.19) vs $(0.39)* .
  • Mix considerations: Q3 included a $40M milestone and $9.3M non-cash license revenue; analysts should adjust recurring revenue run-rate for modeling .
  • Outlook implication: Expect upward revisions to FILSPARI revenue and non-GAAP profitability trajectories; however, model higher Q4 GTN and SG&A ramp into potential FSGS launch .

Notes: Consensus and EBITDA figures marked * are from S&P Global. Values retrieved from S&P Global.

Guidance Changes

(See table above.)

  • No formal quantitative revenue/EPS guidance was issued. Management reiterated qualitative guideposts: Q4 gross-to-net higher with FY ~20%, incremental SG&A into FSGS launch, and sufficient liquidity post-convert repayment with milestone cash receipts in Q4 .

Key Takeaways for Investors

  • Core growth intact: FILSPARI demand, prescriber breadth, and persistence remain strong; KDIGO and REMS changes expand the addressable base and ease use, supporting sustained growth .
  • Quality beat, but lumpy items: Adjust for the $40M milestone and $9.3M non-cash license revenue when setting recurring run-rate; still, underlying FILSPARI trends are robust .
  • Operating inflection: Non-GAAP profitability achieved with improving margins; monitor Q4 GTN headwinds and SG&A ramp into FSGS .
  • FSGS catalyst: Jan 13, 2026 PDUFA (no AdCom) is the next major stock driver; recent DUPLEX/RaDaR data strengthen the case that deeper proteinuria reductions translate into long-term kidney protection .
  • Competitive risk manageable: Management reports limited share impact to date; FILSPARI’s profile and positioning under KDIGO support leadership in IgAN .
  • Liquidity: $254.5M at 9/30 excludes $40M milestone received in October; remaining converts retired; no near-term capital need .
  • Trading setup: Near-term sentiment anchored on durable FILSPARI growth vs. Q4 GTN and PSF seasonality; medium-term skewed to FSGS approval/launch execution and continued evidence generation at major congresses .

Appendix: Additional Relevant Press Releases (Q3 timeframe)

  • FDA approves REMS modification (Aug 27, 2025): quarterly LFT monitoring and removal of embryo-fetal REMS requirements, simplifying access .
  • Q2 2025 results (Aug 6, 2025): FILSPARI U.S. $71.9M; TRx momentum; sNDA for FSGS accepted; milestone revenue noted .
  • Q1 2025 results (May 1, 2025): FILSPARI U.S. $55.9M; sNDA submitted; early IgAN evidence and EU/UK approvals .