Vera Therapeutics (NASDAQ:VERA) reported $10.3 million in third-quarter TRUTAKNA sales, its first partial quarter of commercial revenue, as the company pursues full U.S. approval for the kidney disease treatment.
Vera had received approximately 700 Patient Start Forms since TRUTAKNA’s launch through the Nov. 5 earnings call, Chief Executive Officer Marshall Fordyce said. Chief Commercial Officer Matt Skelton said roughly half of third-quarter revenue reflected demand and half reflected inventory stocking.
The Food and Drug Administration granted TRUTAKNA accelerated approval on July 7 to reduce proteinuria, or excess protein in urine, in adults with primary IgA nephropathy who are at risk of disease progression. Fordyce said Vera submitted a supplemental Biologics License Application seeking full approval based on final results from its ORIGIN 3 trial.
Launch and access
Fordyce described Patient Start Forms as the best early measure of demand, while saying net product revenue would become the primary indicator of progress alongside quarterly form totals. Future form updates will cover completed quarters rather than the period through each earnings call, he said.
Skelton said it was too early to identify an inflection in demand following the presentation of final ORIGIN 3 results at ASN Kidney Week in October. He said the 700 forms were not driven by a small group of physicians and represented patients with both more and less than 1 gram of proteinuria.
Most forms came from the existing pool of diagnosed patients already receiving other treatments, Skelton said. Vera’s sales teams have focused on high-volume physicians and academic centers during the launch.
On insurance coverage, Skelton said Vera was on track to meet its goal of covering 50% of lives by year-end. He said some payer requirements to try another branded treatment first applied to the B-cell modulator class and typically involved FILSPARI or VANRAFIA.
Trial results support full approval bid
Chief Medical Officer Robert Brenner said ORIGIN 3 randomized and dosed 428 adults with IgA nephropathy and met all prespecified endpoints in its final efficacy analysis. At 52 weeks, the placebo-adjusted difference in change in estimated glomerular filtration rate, a measure of kidney function, was 5.6 mL/min.
Through 104 weeks, the annualized rate of kidney function decline was 0.6 mL/min per year with TRUTAKNA, compared with 5.6 mL/min per year with placebo on top of background therapy, Brenner said. The treatment reduced the risk of a composite kidney disease progression endpoint by 76% versus placebo.
Eleven patients receiving TRUTAKNA, or 5%, had a sustained decline in kidney function of at least 30%, compared with 38 patients, or 18%, receiving placebo. No TRUTAKNA patients progressed to dialysis, kidney transplantation or death, compared with seven placebo patients, Brenner said.
Overall adverse events occurred in 75% of TRUTAKNA patients and 78% of placebo patients. Local administration reactions occurred in 30% and 8%, respectively. Brenner said there were no opportunistic infections or clinically relevant cases of hypogammaglobulinemia, a condition involving low antibody levels.
Vera anticipates potential full U.S. approval in mid-2027. Fordyce said the company also plans to submit a European marketing application in the first quarter of 2027 using the same final trial results.
Loss widens as launch spending rises
Vera reported a third-quarter net loss of $93.7 million, or $1.30 per share, compared with $80.3 million, or $1.26 per share, a year earlier. Selling, general and administrative expenses rose to $61.4 million from $27.5 million, primarily reflecting investment in the launch.
Research and development expenses fell to $41.3 million from $56.5 million. Chief Financial Officer Sean Grant said the decrease was primarily due to lower contract manufacturing expenses recorded in research and development; following approval, commercial supply manufacturing costs are capitalized as inventory.
Vera ended September with $384 million in cash equivalents and marketable securities. It drew $75 million from its debt facility in late October, bringing the pro forma balance to $459 million when adjusted solely for that borrowing. Grant said up to $350 million remained available under the facility, subject to conditions.
Additional studies continue
Vera is studying atacicept, TRUTAKNA’s active ingredient, in broader patient populations. Brenner said interim results from the phase 2 PIONEER trial showed a 52% reduction in proteinuria from baseline at 24 weeks in adult IgA nephropathy cohorts.
The company also expects to review data from new monthly-dose cohorts in an ongoing dose-range study later this quarter. Results from a cohort switching from weekly to monthly dosing are expected in the second quarter of 2027, Brenner said.
About Vera Therapeutics (NASDAQ:VERA)
Vera Therapeutics, Inc is a clinical-stage biotechnology company focused on developing treatments for immunological diseases. The company’s research is centered on therapies that target the underlying causes of autoimmune conditions rather than primarily addressing their symptoms.
Vera’s lead product candidate is atacicept, a biologic designed to inhibit the B-cell survival factors BLyS and APRIL. The company has been evaluating atacicept in IgA nephropathy, an autoimmune kidney disease that can lead to progressive loss of kidney function, and has also investigated its potential in other immune-mediated diseases.
