Vera Therapeutics (VERA) investor relations material

Regulatory and clinical update

• Atacicept's BLA is under FDA priority review with a PDUFA date of July 7, and no major review issues have emerged so far.

• Label negotiations are expected later in the review cycle, with anticipation of a broad indication similar to recent competitors, potentially without proteinuria thresholds.

• GFR decline is now seen as the key efficacy endpoint for IgAN therapies, shifting focus from proteinuria.

• No CMC or supply chain issues are anticipated, and manufacturing partners are experienced with commercial products.

• The review team has remained consistent since the pre-NDA meeting.

Commercial strategy and market positioning

• The U.S. market is the primary focus, with over 70% of patients expected to have commercial insurance coverage.

• Early launches of similar IgAN therapies have shown strong demand, with 500 patient start forms in 11 weeks and projected $163M in first-year sales for a competitor.

• Atacicept will be offered as a once-weekly, low-volume auto-injector, aiming for a more patient-friendly experience than competitors.

• An 82-person sales force is fully hired and will be active pre-launch to educate prescribers and identify patients.

• Patient identification will leverage new ICD-10 codes and claims data, targeting about half of U.S. nephrologists.

Market access, reimbursement, and support

• Value and access teams have engaged payers for over eight months, conducting PIE presentations and preparing for launch.

• Early payer policies for similar drugs have been non-restrictive, with only ACE/ARB step edits observed.

• Distribution will be through specialty pharmacy, with gross-to-net benefits from a high proportion of commercial payers.

• A patient support hub is being developed with CoverMyMeds to ensure high-touch onboarding and compliance.