approval timeline and strategy, impact of REMS modification on commercial performance, gross to net discounts and their impact on revenue, FSGS FDA interaction and label expectations, and patient start form growth and seasonality are the key contradictions discussed in Travere Therapeutics' latest 2025Q1 earnings call.
Strong Financial Performance of FILSPARI:
-
reported
net product sales of
$56 million for FILSPARI in Q1, reflecting a
182% year-over-year and
13% quarter-over-quarter increase.
- This growth was driven by strong demand and uptake following full FDA approval, leading to high compliance rates and expanding patient and prescriber bases.
Progress in Pipeline and Regulatory Submissions:
- The company made significant progress towards approving FILSPARI for FSGS, submitting a supplemental new drug application (sNDA) in March.
- This submission aligns with the FDA's plan to grant a priority review, potentially enabling approval and launch by September.
Gross-to-Net Discount Impact and Strategy:
- Travere Therapeutics experienced a higher gross-to-net discount in the first quarter, attributed to insurance coverage changes and Part D redesign.
- Despite these challenges, the company expects strong demand and high compliance rates to drive significant growth in FILSPARI sales throughout the year.
Market Expansion and Product Label Expansion:
- FILSPARI's label expansion to include patients without proteinuria limitations has led to more aggressive treatment, with physicians prescribing at lower proteinuria levels.
- This expansion is supported by updated draft KDIGO guidelines, which recommend earlier intervention and ambitious treatment goals to optimize long-term outcomes.
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