Vera Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported net product revenue of $10.3 million for the quarter ended September 30, 2026, compared to $0 in the prior-year period.
• Reported a net loss of $93.7 million ($1.30 per share) for the quarter, compared to a net loss of $80.3 million ($1.26 per share) in the prior-year quarter.
• Research and development expenses were $41.3 million for the quarter, a decrease from $56.5 million in the prior-year period, primarily due to the capitalization of manufacturing costs for TRUTAKNA commercial supply as inventory following accelerated approval.
• Selling, general and administrative (SG&A) expenses were $61.4 million for the quarter, an increase from $27.5 million in the prior-year period, reflecting investment in the commercial launch.
• For the nine months ended September 30, 2026, net cash used in operating activities was $305.9 million, compared to $171.1 million in the prior-year period.
• Reported $384.0 million in cash, cash equivalents, and marketable securities as of September 30, 2026.
• On a pro forma basis adjusting for a $75 million debt facility draw in late October, cash, cash equivalents, and marketable securities would have totaled $459 million as of September 30, 2026.
• Long-term debt increased to $75.4 million as of September 30, 2026, from $74.8 million as of December 31, 2025.
• Inventory balance was $7.1 million as of September 30, 2026, compared to $0 in the prior period.

Guidance and Future Outlook:

• Anticipates potential full approval of TRUTAKNA in adults with primary IgAN subject to FDA review of the supplemental Biologics License Application (sBLA), expected in mid-2027.
• Plans to submit a Marketing Authorisation Application to the European Medicines Agency in Q1 2027 for standard marketing authorization.
• Management expressed confidence that TRUTAKNA has the potential to become a foundational therapy in IgAN and change the course of the disease.

Business Segments and Product Lines:

• TRUTAKNA (atacicept-vymj) received accelerated FDA approval on July 7, 2026, to reduce proteinuria in adults with primary IgAN at risk for disease progression.
• The U.S. launch has generated approximately 700 Patient Start Forms (PSFs) to date.
• ORIGIN 3 final efficacy analysis demonstrated stabilization of kidney function and a 76% reduction in the risk of composite kidney disease progression versus placebo through two years.
• ORIGIN 3 results showed an annualized eGFR slope of -0.6 mL/min/1.73m²/year with TRUTAKNA compared to -5.6 mL/min/1.73m²/year with placebo (treatment difference of 5.0 mL/min/1.73m²/year).
• Completed sBLA submission to the FDA on November 3, 2026, for full approval of TRUTAKNA in adults with primary IgAN.
• Presented interim results from the Phase 2 PIONEER basket trial for adult IgAN and primary membranous nephropathy cohorts, supporting continued investigation in antibody-mediated glomerular diseases.
• Evaluated pediatric patients with IgAN in the PIONEER trial.
• Approximately 160,000 diagnosed IgAN patients exist in the U.S., with roughly 75% commercially insured.

Market and Competitive Landscape:

• TRUTAKNA is the first approved therapy targeting both BAFF and APRIL for IgAN.
• Management noted growing interest from the IgAN community and encouraged payer coverage policies taking shape.
• The company is focusing on expanding access and providing education to nephrologists to help eligible patients begin treatment.
• TRUTAKNA TRU SUPPORT patient program offers insurance coverage assistance and financial assistance, with eligible commercially insured patients potentially paying as little as $0 out of pocket.

Risks and Challenges:

• Accelerated approval is contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
• TRUTAKNA is contraindicated in patients with serious hypersensitivity to atacicept-vymj or excipients.
• Warnings include increased risk of infections (32% of patients vs. 28% placebo) and immunosuppression; live vaccines are not recommended within 30 days prior to initiation or during treatment.
• Safety and effectiveness in pediatric patients have not been established.
• Data on use in pregnant women is insufficient to evaluate risks of major birth defects or miscarriage.
• Forward-looking statements involve risks related to regulatory approval, commercial launch, market acceptance, payer coverage, and macroeconomic/geopolitical events.

Management Commentary and Tone:

• CEO Marshall Fordyce, M.D., expressed excitement over early launch momentum and stated the transition to a commercial-stage company marks a new chapter.
• CCO Matt Skelton highlighted execution on launch priorities, growing payer coverage, and the focus on expanding access and nephrologist education.
• Management emphasized that ORIGIN 3 data strengthens the clinical foundation for TRUTAKNA and reinforces its potential to change the course of IgAN.

Other Key Points:

• Management hosted a live investor webcast on November 5, 2026, to discuss results.
• Up to $350 million remains available under the debt facility, subject to conditions.
• TRUTAKNA is a self-administered, at-home, 150 mg once-weekly autoinjector.
• The company is a commercial-stage biotechnology firm focused on autoimmune diseases, specifically kidney diseases, founded in 2016 and based in Brisbane, California.