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Travere Therapeutics, Inc. (TVTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 delivered accelerating top-line with total revenue of $74.79M, up 19% QoQ and 66% YoY, led by FILSPARI net sales of $49.64M; revenue modestly beat external consensus, but GAAP EPS of -$0.73 missed, driven by ongoing SG&A/R&D investment and lower other income vs prior year .
  • Commercial KPIs inflected: 693 FILSPARI patient start forms (PSFs) in Q4 vs 505 in Q3 (+37%), reflecting full-approval tailwinds and broader label utilization; FILSPARI full-year sales reached $132.2M .
  • 2025 catalysts: sNDA for FSGS targeted around end of Q1 (first potential approval in FSGS), PDUFA Aug 28, 2025 for REMS liver monitoring modification (monthly→quarterly year 1), European full approval conversion for FILSPARI with expected $17.5M milestone; management expects continued IGAN sales growth in 2025, albeit with higher gross-to-net (high-teens to low-20s) .
  • Balance sheet strengthened by November equity raise (gross $125M; net proceeds ~$134.7M included in year-end cash/marketables of $370.7M), supporting launch and pipeline priorities; pegtibatinase Phase 3 HARMONY enrollment restart now targeted for 2026 after process improvements .

What Went Well and What Went Wrong

What Went Well

  • Strong commercial execution: “we received 693 new patient start forms… a 37% increase from the prior quarter,” with FILSPARI Q4 net sales ~$50M and continued high compliance/persistence, reinforcing adoption breadth and depth .
  • Label expansion tailwind and payer traction: full approval enabled broader use (removal of 1.5 g/g threshold) and “excellent coverage,” with formularies updating authorization criteria to reflect the broader label, easing access for patients with lower proteinuria .
  • Strategic pipeline momentum: Type C meeting completed; sNDA for FSGS planned near end of Q1 2025, potentially first-ever FDA approval in FSGS; KDIGO final guidelines and REMS-modification PDUFA could further de-risk adoption .

Selected quotes

  • “We saw a meaningful inflection in demand following full approval” .
  • “We received 693 new patient start forms… 37% increase from the prior quarter” .
  • “We plan to submit our sNDA… for FSGS around the end of the first quarter of twenty twenty five” .

What Went Wrong

  • EPS miss and persistent losses: GAAP EPS -$0.73 vs external consensus -$0.58 amid continued operating loss and lower other income; non-GAAP EPS -$0.47; total other income fell to $0.4M vs $5.7M in prior year quarter .
  • Tiopronin (Thiola) headwinds: Q4 Tiopronin net sales declined modestly YoY (-5.2% YoY) with management highlighting generic dynamics and expecting further headwinds in 2025 for this smaller segment .
  • Gross-to-net pressure outlook: CFO guides to higher 2025 gross-to-net (high-teens to low-20s), front-loaded early in the year—this will temper net revenue realization despite demand growth .

Financial Results

Headline P&L vs Prior Periods and External Estimates

MetricQ2 2024Q3 2024Q4 2024External Consensus (Q4)
Total Revenue ($M)$54.12 $62.90 $74.79 $73.44 (Zacks/Nasdaq)
GAAP EPS-$0.91 -$0.70 -$0.73 -$0.58 (Zacks/Nasdaq)
Non-GAAP EPS-$0.65 -$0.46 -$0.47 n/a
Gross Profit Margin %96.2% (calc from $54.12M rev; $2.06M COGS) 97.4% (calc from $62.90M; $1.63M COGS) 96.6% (calc from $74.79M; $2.55M COGS) n/a

Notes: Gross margin calculated as (Revenue-COGS)/Revenue using reported totals (see citations).

Segment/Line-Item Breakdown

MetricQ2 2024Q3 2024Q4 2024Q4 2023
FILSPARI Net Product Sales ($M)$27.13 $35.62 $49.64 $14.70
Tiopronin (Thiola) Net Sales ($M)$25.05 $25.38 $23.90 $25.22
Total Net Product Sales ($M)$52.18 $61.00 $73.55 $39.92
License & Collaboration Rev ($M)$1.94 $1.90 $1.24 $5.14
Total Revenue ($M)$54.12 $62.90 $74.79 $45.06

KPIs and Balance Sheet

KPIQ2 2024Q3 2024Q4 2024
FILSPARI Patient Start Forms (PSFs)521 505 693
Cash, Cash Equivalents & Marketable Securities ($M)$325.4 $277.4 $370.7 (includes ~$134.7M net Nov equity)

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
FILSPARI (IgAN) net sales trajectory2025No numeric prior“Grow significantly in 2025 and continue to outpace benchmark launches” Raised qualitatively
Gross-to-net (FILSPARI)2025Mid-to-high teens in 2024 High-teens to low-20s; largest impact early in year Higher vs 2024
Operating cash use2025+Declining trend discussed in 2H24 “Operating cash use will continue to decline over time” Reaffirmed/extended
FSGS sNDA timing2025Update by Q4 call (planned) Submit around end of Q1 2025 Formalized timing
FILSPARI REMS modification (liver monitoring)IgAN labelsNDA submitted; PDUFA set PDUFA Aug 28, 2025 Timetable specified
EU FILSPARI approval status2025EU launches began; CMA granted Expect CMA conversion to full approval in 2025; $17.5M milestone expected Milestone visibility

Earnings Call Themes & Trends

TopicQ2 2024 (Q-2)Q3 2024 (Q-1)Q4 2024 (Current)Trend
IgAN launch momentumSequential PSF growth (521); positioning for full approval; strong payer access Full approval drove higher demand; $35.6M FILSPARI in Q3; 505 PSFs; EU launches 693 PSFs (+37% QoQ); ~$50M FILSPARI sales; strong persistency/compliance Accelerating
KDIGO guidelinesExpected soon; foundational role for FILSPARI anticipated Draft published (Aug) recommending FILSPARI as foundational therapy Final guidelines expected 2025; continue to drive earlier initiation and lower targets Supportive tailwind
REMS modificationExplored at full approval; scenarios considered sNDA submitted PDUFA Aug 28, 2025; first step monthly→quarterly yr1; eventual removal plan De-risking adherence
FSGS regulatory pathPARASOL endpoint work; plan to engage FDA Type C meeting planned sNDA submission targeted around end of Q1 2025; potential first approval Closer to filing
Competition/combination therapyExpect combinations (kidney-targeted + immune) Full approval strengthens profile vs new entrants Confident vs new ERA entrants; combinations expected; payer readiness Balanced confidence
Gross-to-netNoted dynamics; improving pull-through n/a2025 GTN high-teens/low-20s; front-loaded Some headwind
Pegtibatinase (HCU)Phase 3 underway; 2026 topline Enrollment pause to 2026 restart earliest CMC improvements; restart enrollment in 2026 Pushed to 2026

Management Commentary

  • CEO on demand inflection: “In the fourth quarter, net sales [of FILSPARI] grew by nearly 40% compared to the third quarter and we saw a meaningful inflection in demand following full approval” .
  • CCO on access and label: “We continue to have excellent coverage… updates of authorization criteria reflecting the broader… label… will further ease access for patients with lower proteinuria levels” .
  • CMO on foundational role: “Foundational treatment is defined as non immunosuppressive, kidney targeted and nephroprotective… with efficacy based on superior kidney function preservation from a head to head comparison” .
  • CFO on 2025 setup: “We believe net product sales of [FILSPARI]… will grow significantly in 2025… [but] expect a moderate increase in gross to net… high teens to low 20s, greatest impact early in the year” .
  • Program update: “On track to submit an sNDA for an FSGS indication around the end of the first quarter of 2025” .

Q&A Highlights

  • Competitive landscape: Management emphasized FILSPARI’s dual pathway blockade and head-to-head superiority vs irbesartan, noting likely segmentation for new entrants and confidence in dosing flexibility and payer positioning .
  • REMS path: First step targeted is monthly→quarterly liver monitoring in year 1; agency has discussed ~3,000 patients over two years exposure before considering full removal .
  • PSF conversion and persistence: Company reports strong fulfillment and high compliance/persistence; improved REMS process has reduced leakage, aiding revenue conversion .
  • FSGS launch readiness and pricing: ~80% prescriber overlap with IgAN; preparation focused on physician education and value story; pricing strategy to ensure broad access, with doubled dose potentially implying higher regimen cost though details TBD .
  • Gross-to-net framework: Expect GTN in high-teens/low-20s in 2025, front-loaded in Q1, then more even through the year .

Estimates Context

  • S&P Global consensus via our SPGI feed was unavailable at the time of analysis (tool limit). Values retrieved from S&P Global were unavailable.
  • External consensus (Zacks/Nasdaq): Revenue $73.44M; EPS -$0.58. Actual Q4 revenue $74.79M (beat), GAAP EPS -$0.73 (miss). Segment beats: FILSPARI $49.64M vs ~$45.31M external; Tiopronin $23.90M vs ~$24.03M .

Key Takeaways for Investors

  • FILSPARI demand and breadth accelerated post-full approval (PSFs +37% QoQ), with ~$50M Q4 sales; adoption into lower-proteinuria patients and payer alignment support continued growth into 2025 .
  • 2025 IGAN revenue growth should remain strong, but model a higher gross-to-net (high-teens/low-20s), especially weighted to Q1 seasonality .
  • Multiple near-term catalysts could unlock value: FSGS sNDA filing (end of Q1), REMS-mod PDUFA (Aug 28), EU full approval conversion ($17.5M milestone), and KDIGO finalization—all pointing to reduced friction and greater access .
  • Tiopronin is a manageable headwind amid generics and is a shrinking percent of mix; the story is increasingly FILSPARI-driven .
  • Liquidity is solid post-November raise (year-end cash/marketables $370.7M); management expects operating cash use to decline over time as revenues scale and milestone inflows arrive .
  • Watch competitive ERA entries and complement/B-cell agents: Management frames combinations as likely, with FILSPARI as the foundational nephroprotective agent; payer positioning and pricing strategy appear prepared for evolving combination paradigms .
  • Execution risk remains on regulatory (FSGS endpoint acceptance, REMS changes) and manufacturing (pegtibatinase scale-up to 2026 restart), but core commercial trajectory and guideline tailwinds are supportive .