Did Travere Therapeutics beat or miss consensus estimates last quarter?

What is the revenue and EPS growth rate for Travere Therapeutics year over year?

What were the key takeaways from Travere Therapeutics’s earnings call?

What is Travere Therapeutics's latest dividend and current dividend yield?

What is Travere Therapeutics's gross profit margin?

What were the key takeaways from Travere Therapeutics's earnings call?

What guidance did Travere Therapeutics's management provide for the next earnings period?

What factors drove the changes in Travere Therapeutics's revenue and profit?

- **IgA Nephropathy Dominance**: Q4 FILSPARI sales up 144% YoY, with record 908 new patient starts, solidifying leadership amid competition.
- **FSGS Regulatory Watch**: PDUFA date extended to April 13, 2026, with FDA focused on proteinuria endpoint. FDA engagement reinforces confidence in FILSPARI's FSGS potential.
- **Pipeline Catalysts**: Pegtibatinase Phase III resumes, targeting first disease-modifying therapy for homocystinuria. Q1 2026 demand trends support $1B+ IgA nephropathy peak sales.

**【CEO Summary Section】**
- **Record Growth in IgA Nephropathy**: FILSPARI achieved $103 million in Q4 net sales, up 144% YoY, driven by 908 new patient starts in Q4, the highest quarterly demand to date.
- **FSGS Regulatory Momentum**: sNDA for FSGS treatment received a new PDUFA date of April 13, 2026, with FDA engagement focused on clinical benefit characterization. Conviction remains strong in FILSPARI's proteinuria reduction profile.
- **Pipeline Expansion**: Pegtibatinase Phase III HARMONY study resumed site activation, targeting classical homocystinuria with potential to become first disease-modifying therapy.

**【CFO Financial Commentary】**
- **Revenue Performance**: Full-year 2025 net product sales reached $410.5 million, with FILSPARI contributing $322 million. Q4 gross to net discounts expected to rise modestly to mid-20% range.
- **Balance Sheet Strength**: $322.8 million in cash as of Q4, supported by $40 million milestone from CSL and $10 million from Chugai acquisition. No near-term capital needs anticipated.
- **Expense Management**: R&D expenses $57.9 million (Q4 2025), SG&A $101.7 million, driven by FSGS launch readiness and pipeline advancement.

**【Q&A Highlights】**
- **Market Penetration**: FILSPARI penetration in IgA nephropathy under 10% of addressable population, with 80% prescriber overlap with FSGS. Q1 2026 demand continues strong post-FDA sNDA update.
- **Competitive Landscape**: Otsuka's APRIL blocker launch shows early momentum, but FILSPARI maintains leadership as foundational therapy. No evidence of switching from FILSPARI to new entrants.
- **FDA Interactions**: FDA focused on proteinuria as validated endpoint for FSGS. Label expectations include broad applicability across FSGS forms, pending PDUFA decision.
- **Pegtibatinase Trial Design**: HARMONY study powered for ≥67% homocysteine reduction, with secondary analysis on clinically meaningful thresholds (e.g., <12 µmol/L).

Travere Therapeutics, Inc. (TVTX) Q4 2025 Earnings Call Transcript

- **Revenue Surge**: FILSPARI sales up 155% YoY to $90.9M, driven by guideline adoption and REMS simplification.
- **FSGS Approval Path**: FDA clears way for January 2026 approval, with no advisory committee needed.
- **Global Expansion**: Japan's Chugai acquisition of Renalys accelerates sparsentan trials; Europe sees expanded access via CSL Vifor.
- **Financial Strength**: $254.5M cash, no near-term capital needs, and non-GAAP net income up 48% YoY.
- **Pipeline Momentum**: Pegtibatinase manufacturing complete; HARMONY study restarts in 2026 for classical HCU.

**【CEO Summary Section】**
- **Revenue Growth**: U.S. net product sales for FILSPARI reached $90.9 million in Q3, up 155% YoY, driven by strong demand and new prescribers. Global partners like CSL Vifor and Renalys (acquired by Chugai) are expanding access in Europe, Japan, and beyond.
- **FILSPARI Expansion**: FDA removed REMS embryo-fetal toxicity restrictions, aligning monitoring with clinical practice. KDIGO guidelines now recommend FILSPARI as a first-line therapy for IgA nephropathy (IgAN), reinforcing its nephroprotective role.
- **FSGS Milestone**: FDA no longer requires an advisory committee for the sNDA in FSGS, advancing potential approval in January 2026. FILSPARI is the only dual ERA-RAS inhibitor with 2-year data showing 50% proteinuria reduction.
- **Pipeline Progress**: Pegtibatinase manufacturing scale-up complete, enabling HARMONY study restart in 2026 for classical HCU. Japan's PMDA approved Phase III trials for sparsentan in FSGS and Alport syndrome.

**【CFO Financial Commentary】**
- **Top Line**: Total revenue $164.9 million (Q3), including $90.9M FILSPARI sales and $40M milestone from CSL Vifor. Non-GAAP net income $52.8M ($0.59 EPS), up from $35.6M ($0.46) YoY.
- **Cost Management**: R&D $51.9M (flat YoY), SG&A $86.5M (+32% YoY) due to FSGS launch prep. Cash balance $254.5M post-convertible note repayment, with no near-term capital needs.
- **Gross to Net**: <2% benefit in Q3, expecting higher discounts in Q4. Full-year gross to net ~20%.

**【Q&A Key Highlights】**
- **REMS Impact**: Physicians welcomed quarterly liver monitoring, boosting access for lower-risk patients. Q3 saw highest daily patient starts, with 731 new prescribers despite summer seasonality.
- **Competitive Dynamics**: FILSPARI outperformed despite launches of iptacopan and atrasentan, driven by guideline alignment and real-world evidence.
- **FSGS Launch Prep**: 30% of IgAN prescribers also treat FSGS. Teams ready for January 2026 launch, with incremental SG&A investments for targeted outreach.
- **PEGtibatinase Supply**: First commercial batches manufactured, with FDA interactions planned for 2026 study restart.
- **Japan Expansion**: Renalys' acquisition by Chugai accelerates sparsentan trials, with Phase III data expected in Q4 2025 for IgAN.


Travere Therapeutics, Inc. (TVTX) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: U.S. net product sales of FILSPARI surged 82% YoY to $71.9 million, driven by 43% YoY increase in new patient starts.
- **FSGS Breakthrough**: sNDA for FILSPARI in FSGS targets January 2026 approval, with potential to address 70,000+ FSGS patients with no alternative therapies.
- **Financial Strength**: $319.5 million cash balance and $11.9 million non-GAAP net income support expansion into FSGS and HCU pipeline.
- **Regulatory Momentum**: REMS modifications expected in August 2025, with FSGS Advisory Committee likely in Q4 2025.

**【CEO Summary Section】**
- **Outstanding Q2 Performance**: FILSPARI achieved record U.S. net product sales of $71.9 million, driven by strong demand and new prescriber expansion. The company highlighted FILSPARI's positioning as the foundational therapy for IgA nephropathy (IgAN), with 745 new patient start forms in Q2, a 43% YoY increase.
- **FSGS Expansion Momentum**: The sNDA for FILSPARI in FSGS is on track for a January 2026 PDUFA date. If approved, FILSPARI would be the first treatment for FSGS, targeting an underserved patient population with no alternative therapies.
- **Pipeline Progress**: The HARMONY study for pegtibatinase in classical homocystinuria is expected to restart enrollment next year, supported by manufacturing scale-up.

**【CFO Financial Commentary】**
- **Revenue Growth**: Total revenue reached $114.4 million, with U.S. net product sales up 82% YoY to $94.8 million. FILSPARI contributed $71.9 million, while THIOLA/THIOLA EC sales were $23 million, though facing generic competition.
- **Financial Health**: Cash balance stood at $319.5 million, bolstered by a $17.5 million milestone payment from CSL Vifor. Non-GAAP net income was $11.9 million, reflecting improved profitability despite increased SG&A expenses for FSGS preparation.

**【Q&A Key Highlights】**
- **Regulatory Updates**: The FDA's PDUFA date for REMS modifications (August 28, 2025) and FSGS approval (January 13, 2026) are key milestones. The company anticipates an Advisory Committee meeting in Q4 2025 for FSGS.
- **Market Dynamics**: Despite new competitors, FILSPARI maintains leadership in IgAN, with 70% of addressable patients in the sub-1.5g proteinuria range. Conversion rates to therapy remain strong, with persistence rates unchanged.
- **FSGS Strategy**: The sNDA leverages PARASOL findings validating proteinuria as a surrogate endpoint. DUPLEX study data showed FILSPARI-treated patients had a 67%-77% lower risk of kidney failure compared to irbesartan.


Travere Therapeutics, Inc. (TVTX) Q2 2025 Earnings Call Transcript

- **FILSPARI Growth Accelerates**: Q1 sales $55.9M (+182% YoY), 703 new starts, 13% QoQ growth. European full approvals expand global reach.
- **FSGS Regulatory Momentum**: sNDA submitted March 2025, potential approval September 2025 as first-ever FSGS treatment.
- **PEG T Clinical Progress**: Phase III restart planned 2026; Phase 1/2 data published in top journal validates disease-modifying potential.
- **Financial Strength**: $322M cash, 2025 FILSPARI sales >90% growth, outpacing rare disease peers.
- **Market Leadership**: 90% patient satisfaction, 75% nephrologists targeting <0.5g proteinuria post-KDIGO guidelines.

**【CEO Summary Section】**
- FILSPARI Q1 net sales reached $55.9M, up 182% YoY, driven by 703 new patient starts and 13% QoQ growth. Expansion into FSGS with sNDA submission in March, targeting approval by September 2025. PEG T Phase III restart planned for 2026 with potential disease-modifying impact in HCU.
- FILSPARI's unique dual pathway inhibition (endothelin-1 and angiotensin-II) delivers 70% proteinuria reduction vs. irbesartan, with 60% achieving remission in SPARTAN study. European and UK full approvals expand global reach.

**【CFO Financial Update】**
- Total revenue $81.7M (Q1 2025), including $55.9M FILSPARI net sales. Gross to net discounts 20% vs. 17% prior year due to Part D redesign. R&D expenses $46.9M (-5% YoY), SG&A $72.8M (+13% YoY) reflecting launch investments.
- Cash balance $322.2M, with $17.5M milestone from CSL Vifor for European approvals. FILSPARI 2025 net sales projected to grow >90% YoY, outpacing rare disease benchmarks.

**【CMO Clinical Highlights】**
- FILSPARI SPARTAN study shows 70% proteinuria reduction and 60% remission rates. Anti-inflammatory effects (50% CD163 reduction) validate chronic kidney disease benefit. FSGS sNDA supported by consistent proteinuria response across all subtypes, including genetic and pediatric patients.
- PEG T Phase 1/2 data accepted in Genetics in Medicine, demonstrating potential to reduce homocysteine levels in HCU. Phase III restart planned post-IND submission.

**【CCO Commercial Execution】**
- 90% patient satisfaction with Travere Total Care services, 70% of 70,000 IgAN patients now addressable below 1.5g proteinuria threshold. FSGS launch prep underway with 30,000 addressable patients, leveraging existing nephrology network.
- Payer coverage expanded with REMS easing, 75% of nephrologists targeting <0.5g proteinuria post-KDIGO guideline alignment.

**【Q&A Key Takeaways】**
- FDA feedback on FSGS sNDA consistent with IgAN process, priority review expected. FILSPARI pricing for FSGS likely double IgAN rate due to disease severity. Novartis sparsentan launch not impacting demand; FILSPARI's 24-week kidney function data differentiates adherence rates.
- PEG T enrollment restart timeline tied to IND submission and manufacturing progress. Gross to net headwinds easing in 2H2025 as Part D redesign effects diminish.

Travere Therapeutics (TVTX)-1 May 25-2025 Q1 Earnings call transcript

- **FILSPARI Growth Accelerates**: Q4 2024 sales up 39.9% YoY, driven by 37% new patient starts
- **FSGS Expansion**: sNDA submission planned for end-Q1 2025, targeting 30,000 US patients
- **REMS Simplification**: Quarterly liver monitoring request under review for August 2025 PDUFA date
- **Pegtibatinase Momentum**: Manufacturing progress on track for 2026 Phase III restart
- **Financial Strength**: $370.7M cash balance post-2024 financing

**【CEO Opening Remarks】**
- Achieved a remarkable year with FDA full approval of FILSPARI for IgA nephropathy in September 2024.
- Q4 net sales of FILSPARI grew 39.9% YoY, driven by 37% increase in new patient starts and broader label adoption.
- Strategic focus on: 
  1. Solidifying FILSPARI as foundational therapy in IgAN
  2. Submitting sNDA for FSGS by end-Q1 2025
  3. Restarting pegtibatinase Phase III in 2026
- Well-capitalized with $370.7M cash post-2024 financing

**【CFO Financial Update】**
- Q4 2024 net product sales: $73.5M (FILSPARI: $49.6M, Thiola: $23.9M)
- Full year 2024 net product sales: $226.7M (+79.8% YoY)
- R&D expenses: $62.1M (Q4 2024) vs $59.7M (Q4 2023)
- SG&A expenses: $69.5M (Q4 2024) vs $63.6M (Q4 2023)
- Cash balance: $370.7M as of Dec 31, 2024
- Expect moderate increase in FILSPARI gross-to-net discounts in 2025

**【Q&A Key Highlights】**
1. **Competitive Landscape**
- FILSPARI maintains strong position despite Novartis/Fabhalta launch
- Differentiated profile: dual angiotensin/endothelin inhibition vs single pathway competitors
- Early proteinuria targets (0.3g/g) vs competitors' 1.5g/g thresholds

2. **FSGS Launch Preparation**
- 80% overlap in IgAN/FSGS prescribers
- Potential 30,000 addressable FSGS patients in US
- sNDA submission planned for end-Q1 2025
- Regulatory discussions indicate strong clinical data support

3. **REMS Modification**
- FDA PDUFA date set for August 2025 to review quarterly liver monitoring request
- Long-term goal: full REMS removal after 3,000 patient exposure
- Current compliance rates >85%, no material impact on conversion

4. **Pegtibatinase Update**
- Manufacturing scale-up progressing with CDMO partners
- Enrollment restart in HARMONY Phase III study expected in 2026
- Focus on optimizing CMC process for HCU disease-modifying therapy

Actual												-0.2	-0.58	-0.44	-2.37	-0.96	-0.64	-0.59	-0.84	-1.2	-1.05	-1.09	-1.03	-1.27	-1.13	1.97	-1.18	-1.76	-0.91	-0.7	-0.73	-0.47	-0.14	0.28	0.03
Forecast												-0.562	-0.46	-0.5157	-0.43	-0.522	-0.6833	-0.5617	-0.7357	-0.87	-0.9389	-0.9478	-1.134	-1.2007	-1.0886	-1.0644	-1.1576	-0.9586	-0.791	-0.6691	-0.562	-0.567	-0.3117	-0.3037	0.0024
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+64.41%	-26.09%	+14.68%	-451.16%	-83.91%	+6.34%	-5.04%	-14.18%	-37.93%	-11.83%	-15.00%	+9.17%	-5.77%	-3.80%	+285.08%	-1.94%	-83.60%	-15.04%	-4.62%	-29.89%	+17.11%	+55.09%	+192.20%	+1150.00%

TVTX

TVTX fundamentals

TVTX Q4 2025 Earnings

Earnings Call

You can ask Aime

TVTX

TVTX fundamentals

TVTX Q4 2025 Earnings

Earnings Call

TVTX Earnings Call Summary for Q4/20254:30 PM on Feb 19, 2026

TVTX Earnings Call Summary for Q3/20254:30 PM on Oct 30, 2025

TVTX Earnings Call Summary for Q2/20254:30 PM on Aug 6, 2025

TVTX Earnings Call Summary for Q1/20254:30 PM on May 1, 2025

TVTX Earnings Call Summary for Q4/20244:30 PM on Feb 20, 2025

You can ask Aime