Vera Therapeutics (VERA) investor relations material

Key clinical results and implications

• Final efficacy analysis from pivotal phase III trial showed a 5 mL/min/year GFR benefit over placebo, normalizing kidney function decline in high-risk IgAN patients over two years.

• No patients on TRUTAKNA met hard clinical outcomes (dialysis, transplant, or death), compared to eight on placebo; composite kidney endpoint hazard ratio was 0.24, indicating a 76% risk reduction.

• TRUTAKNA is the first dual BAFF/APRIL B-cell modulator on the market, with a strong safety profile and a user-friendly weekly autoinjector.

• Data are being submitted for presentation at ASN and for publication, with an sBLA planned in Q4 targeting full approval by mid-2027.

• The broad Accelerated Approval label covers any patient at risk of disease progression, with plans to expand to additional patient populations and adjacent indications.

Competitive landscape and differentiation

• TRUTAKNA's efficacy delta (5.0) exceeds that of the main competitor (4.5), and it is the first to report composite kidney endpoint data among B-cell modulators.

• The dual mechanism (BAFF/APRIL) and autoinjector differentiate it from APRIL-only competitors; long-term outcomes and GFR data are expected to be key differentiators.

• Additional competitors are expected, but current resourcing and market strategy remain unchanged, with a focus on maintaining leadership and high data standards.

Commercial launch and market opportunity

• Over 350 patient start forms were generated in the first 10 weeks, indicating strong early demand and market growth.

• The U.S. market is estimated at 160,000 biopsy-confirmed IgAN patients, with a potential $10–$20 billion market size.

• Commercial infrastructure includes 82 sales reps targeting 6,000 nephrologists, with early telemetry supporting right-sized coverage.

• Objective is payer parity with other drugs, ensuring physician-driven prescribing decisions.

• Revenue and patient start forms will be reported quarterly, with the first revenue update expected in November.