Travere Therapeutics (TVTX) investor relations material

FDA approval and clinical significance

• FILSPARI (sparsentan) received FDA approval to reduce proteinuria in adults and pediatric patients aged eight and older with FSGS without nephrotic syndrome, marking it as the first and only approved therapy for this condition.

• Approval is based on phase III DUPLEX study data, showing significant reductions in proteinuria, improved eGFR, and kidney outcomes in the defined patient population.

• FILSPARI demonstrated a 48% reduction in proteinuria versus 27% for irbesartan at week 108, with favorable eGFR outcomes and lower progression to kidney failure.

• FILSPARI achieved more than three times higher complete remission rates at key proteinuria thresholds versus irbesartan.

• FILSPARI was generally well-tolerated, with a safety profile consistent with IgAN, and common adverse reactions included peripheral edema, hypotension, hyperkalemia, dizziness, anemia, and transaminase elevations; liver monitoring is required.

Patient population and disease burden

• FSGS is a rare, severe, and progressive kidney disease with the lowest 7-year kidney survival rate among primary glomerular diseases and a high unmet need.

• Less than 20% of FSGS patients have active nephrotic syndrome at a single point in time; the majority are eligible for FILSPARI.

• The addressable US patient population for FILSPARI now exceeds 100,000, including over 30,000 biopsy/genetically confirmed FSGS patients without nephrotic syndrome and over 70,000 with IgAN.

• Over 4,000 people in the U.S. are on the kidney transplant waitlist due to FSGS, and up to 55% of transplant patients experience disease recurrence.

• Median time to kidney failure is 5–10 years for 30–60% of patients, highlighting the urgency for effective treatments.

DUPLEX study results: efficacy

• FILSPARI showed a 29% greater reduction in proteinuria (UPCR) from baseline compared to irbesartan in FSGS patients without nephrotic syndrome (p=0.0075).

• FILSPARI demonstrated a clinically meaningful effect on eGFR, with a slower decline in kidney function compared to irbesartan (chronic eGFR slope difference: 2.5 mL/min/1.73m²/year, p=0.015).

• The risk of kidney failure was significantly reduced in the FILSPARI group (RR: 0.19, p=0.018) in patients without nephrotic syndrome.