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Earnings

Vera Books First TRUTAKNA Sales After July Launch

Net product revenue was $10.3 million in the third quarter as the company posted a $93.7 million net loss and filed for full FDA approval.

Vera Therapeutics, Inc. (VERA), a commercial-stage biotechnology company, reported net product revenue of $10.3 million for the quarter ended September 30, 2026, after receiving FDA accelerated approval for TRUTAKNA (atacicept-vymj) on July 7 and launching the drug in the United States.

The year-ago quarter had no product revenue. The company said it had received approximately 700 Patient Start Forms to date following the launch.

Net loss widened to $93.7 million, or $1.30 a share, from $80.3 million, or $1.26 a share, a year earlier. Cost of sales was $3.3 million.

Selling, general and administrative expenses rose to $61.4 million from $27.5 million a year earlier, which the company said reflected investment in the commercial launch. Research and development expenses fell to $41.3 million from $56.5 million, primarily because manufacturing costs for TRUTAKNA commercial supply, previously categorized as research and development, were capitalized as inventory after accelerated approval.

Founder and Chief Executive Officer Marshall Fordyce said the company was “excited by the early momentum of the TRUTAKNA launch.” Chief Commercial Officer Matt Skelton said the team was “executing on the launch priorities we established for TRUTAKNA” and was “encouraged by the payer coverage policies taking shape.”

Vera presented final efficacy results from the ORIGIN 3 trial at ASN Kidney Week 2026, with a simultaneous publication in The New England Journal of Medicine. Through 104 weeks, the annualized eGFR slope was -0.6 mL/min/1.73m²/year with TRUTAKNA compared with -5.6 mL/min/1.73m²/year with placebo, a treatment difference of 5.0 mL/min/1.73m²/year (p<0.0001). The company said the analysis demonstrated stabilization of kidney function and a 76% reduction in risk of composite kidney disease progression versus placebo through two years.

On November 3, 2026, Vera completed a supplemental Biologics License Application submission to the FDA for full approval of TRUTAKNA in adults with primary IgAN, based on that analysis. The company said potential full approval, subject to FDA review, is expected in mid-2027. It also said a Marketing Authorisation Application to the European Medicines Agency is planned for the first quarter of 2027.

The accelerated indication is to reduce proteinuria in adults with primary IgAN at risk for disease progression. The company said continued approval may be contingent upon verification of clinical benefit in a confirmatory trial. It cited approximately 160,000 diagnosed IgAN patients in the U.S., roughly 75% of whom are commercially insured.

Cash, cash equivalents and marketable securities were $384.0 million as of September 30, 2026, down from $714.6 million at December 31, 2025. In late October the company drew $75 million under its debt facility. On a pro forma basis adjusting solely for that borrowing as if it had occurred on September 30, the cash balance would have been $459 million. As of November 5, up to $350 million remained available under the facility, subject to certain conditions.

During the nine months ended September 30, 2026, net cash used in operating activities was $305.9 million, compared with $171.1 million a year earlier, which the company said was primarily due to increased investment in the TRUTAKNA launch.

Vera also presented interim results from the adult IgAN and primary membranous nephropathy cohorts of the Phase 2 PIONEER basket trial of atacicept at ASN Kidney Week and outlined the trial’s evaluation of pediatric patients with IgAN. The company said those interim results support continued investigation of atacicept in antibody-mediated glomerular diseases.

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