STIFEL 2026 HEALTHCARE CONFERENCE - TRAVERE THERAPEUTICS INC

Explicit Guidance:

• No specific quantitative financial guidance (revenue, earnings, margins, capex, cash flow) provided for FY2025 or beyond.
• Qualitative outlook: "Definitely a path to profitability" cited as a future trajectory.
• Spend outlook: Expectation of an "increase in SG&A" in the upcoming year to support a full year of FSGS/IGAN operations and advancement of Pegdebatinase and SIVOR.
• Share count/dividends: No mention.

Business-Segment Outlook:

• FSGS (Focal Segmental Glomerulosclerosis): Uptake expected to be "sustained over time" following rapid acceleration; no evidence of a "bolus" effect. Net price trajectory remains "on an upward trajectory" as patients titrate from 400mg to 800mg target dose; strong adherence to titration protocol expected to lead to majority of patients reaching target dose.
• IGAN (IgA Nephropathy): Focus shifting to "continuing patients" rather than new starts; demand expected to remain strong despite seasonality. Management anticipates continued positioning and strength of Filspary despite the entry of competitor B-cell therapies (ciboprenolamab, atacicep).
• Pipeline (SIVOR - BTK inhibitor): Goal to submit IND to FDA "this year." Next steps include additional PK/PD and dosing work to confirm target dose for global populations. Planned to advance into "immune-driven FSGS" and "minimal change disease" (timing not specified).
• Pipeline (Pegdebatinase): Phase 3 trial "well on track" to replicate Phase 2 findings (67% reduction in homocysteine). Trial duration extended to 24 weeks for durability; primary endpoint (total homocysteine reduction) agreed upon with FDA. Sub-study on patient protein intake capability will generate data, potentially available by BLA submission next year.

Market and Competitive Outlook:

• IGAN Treatment Landscape: Anticipates "dynamism" in the market as nephrologists manage time constraints from six to seven new companies. Believes the shift to B-cell therapies will drive market growth via earlier treatment initiation rather than displacing Filspary.
• Combination Therapy Trends: Expecting "Filspari plus SGLT2s" to become the kidney-directed standard, with immune-targeted therapies (B-cell/complement inhibitors) added on top. Payers are showing receptivity to this combination strategy.
• Competitive Positioning: In FSGS, competitors (e.g., Fanerine, BTK inhibitors) viewed as complementary or focused on specific genotypes rather than a direct replacement for Filspary as foundational therapy. FSGS label exclusions (nephrotic syndrome) not seen as material impediment to use in non-nephrotic population.
• Payer Dynamics: Payers increasingly aligning with KDIGO guidelines; observing "step edits" where access to immune-targeted therapies requires prior use of Filspary.

Macro / Industry Outlook:

• Regulatory Environment: FDA's push for better evidence and endpoints driving a "renaissance" in rare kidney disease. Anticipates continued regulatory alignment on biomarkers (e.g., proteinuria, LPA reductions) for faster approval pathways.
• Clinical Guidelines: KDIGO guidelines shifting treatment goals to "complete remission" and stabilized eGFR, necessitating aggressive early treatment which favors the combination of Filspary and other agents.
• Dietary Factors: Recognized as a significant variable in homocysteine management; Phase 3 trials will manage diet stability closely.

Strategic Initiatives:

• Leadership Transition: CEO Eric Dubé transitioning to a role where incoming CEO Bradley Campbell will set future vision and specific guidance; Campbell will focus heavily on the Pegdebatinase opportunity.
• Pipeline Expansion: Advancement of SIVOR (bask-inhibitor) into multiple renal indications beyond primary membranous nephropathy.
• Data Collaboration: Independent work on endpoint validation for FSGS/membranous nephropathy to parallel industry efforts (e.g., Paradigm), not waiting for competitor readouts to proceed.
• Commercial Infrastructure: Continued investment in patient services hub to ensure adherence to Filspary titration protocols.

Risks and Headwinds to Outlook:

• Seasonality vs. Market Shift: While seasonality is the primary driver of Q3/Q4 demand dips in IGAN, uncertainty remains regarding long-term prescriber behavior and potential trade-offs to newer B-cell therapies.
• Regulatory/Endpoint Uncertainty: For Pegdebatinase, while homocysteine is the agreed primary endpoint, final approval could depend on demonstrating functional benefits (e.g., protein intake capability), though this is not currently required for full approval.
• Supply Chain/Manufacturing: Past manufacturing delays occurred; while currently "back on track" with commercial scale manufacturing, this remains a historical risk factor to watch.
• Payer Step Edits: Dependence on payers adopting step-edit requirements for immune therapies on top of Filspary introduces execution risk.

Management Tone on the Future:

• Confidence: High confidence in "phenomenal performance" of Filspary, "strong" adherence to dosing, and "encouraging" safety profile of SIVOR (150+ patients treated).
• Forward-Looking Optimism: Describes 2025/next year as "really exciting" with a focus on changing lives in HCU and expanding the Filspary franchise.
• Strategic Caution: Management explicitly defers specific financial guidance to the incoming CEO, citing the need for the new leadership to set the vision and evaluate the pivot point between new patient starts and patient retention.

Miscellaneous:

• Pipeline Synergies: SIVOR mechanism (reducing lipoprotein A and proteinuria) viewed as complementary to Filspary's mechanism.
• Market Size: IGAN addressable population noted as "more than two times" the size of the FSGS population, though FSGS patients show higher "sense of urgency."
• Pricing Strategy: Pegdebatinase pricing will be determined post-Phase 3 data release, aiming for a "broad range" to ensure patient access.