Vera’s TRUTAKNA launch posts $10.3 million in first sales

By Grace Kim

What do the launch numbers show?

$10.3 million in third-quarter TRUTAKNA sales marked Vera Therapeutics’ first partial quarter of commercial revenue, while the net loss widened to $93.7 million, or $1.30 a share, from $80.3 million, or $1.26, a year earlier.

Chief Commercial Officer Matt Skelton said roughly half of revenue reflected demand and half reflected inventory stocking. That mix means early bookings combined patient demand with inventory stocking, rather than showing recurring demand alone.

Selling, general and administrative expenses rose to $61.4 million from $27.5 million, primarily reflecting launch investment. Research and development expense fell to $41.3 million from $56.5 million.

Chief Financial Officer Sean Grant said the decline was "primarily due to lower contract manufacturing expenses" recorded in R&D. Grant said that, following approval, commercial-supply manufacturing costs are capitalized as inventory rather than recorded as R&D expense.

Vera ended September with $384 million in cash equivalents and marketable securities. It borrowed $75 million from its debt facility in late October, lifting pro forma cash to $459 million when adjusted only for that draw. Up to $350 million remained available, subject to conditions.

Takeaway: Vera had $459 million in pro forma liquidity after the October draw, but the launch drove expenses sharply higher while sales remained in their first partial commercial quarter.

What do patient demand and insurance access show?

Through the Nov. 5 earnings call, Chief Executive Officer Marshall Fordyce said Vera had received "approximately 700 Patient Start Forms since TRUTAKNA’s launch." He called the forms the best early measure of demand.

Fordyce said net product revenue would become the primary progress indicator alongside quarterly form totals. Future updates would cover completed quarters rather than the period through each call, making comparisons cleaner.

Matt Skelton said it was too early to identify a demand inflection after final ORIGIN 3 results at the ASN Kidney Week meeting in October. He said the 700 forms did not come from a small group of physicians and represented patients with both more and less than 1 gram of proteinuria, or excess protein in urine.

Most forms came from the existing pool of diagnosed patients already receiving other treatments. Vera’s sales teams have focused on high-volume physicians and academic centers.

Skelton said Vera was on track to meet its goal of covering 50% of lives by year-end. He said payer requirements to try another branded treatment first applied to the B-cell modulator class, or drugs that target B cells, and typically involved FILSPARI or VANRAFIA.

Takeaway: Patient interest looked broad, but payer requirements still determine how much of it reaches covered sales.

What does ORIGIN 3 show?

The Food and Drug Administration granted TRUTAKNA accelerated approval on July 7 to reduce proteinuria in adults with primary IgA nephropathy at risk of progression. The disease is autoimmune and can progressively impair kidney function.

Vera has submitted a supplemental Biologics License Application, or BLA, seeking full U.S. approval based on final ORIGIN 3 results.

Chief Medical Officer Robert Brenner said ORIGIN 3 randomized and dosed 428 adults and met all prespecified endpoints in its final efficacy analysis. At 52 weeks, the placebo-adjusted difference in the change in estimated glomerular filtration rate, a measure of kidney function, was 5.6 mL/min.

The final results showed:

• Through 104 weeks, annualized kidney-function decline was 0.6 mL/min per year with TRUTAKNA versus 5.6 mL/min per year with placebo, both on top of background therapy.
• TRUTAKNA cut the risk of a composite, or combined, kidney-disease progression endpoint by 76% versus placebo.
• Sustained kidney-function decline of at least 30% occurred in 11 patients, or 5%, receiving TRUTAKNA and 38 patients, or 18%, receiving placebo.
• No TRUTAKNA patients reached dialysis, kidney transplantation or death, versus seven placebo patients.

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 a potential full U.S. approval in mid-2027. It plans to submit a European marketing application in the first quarter of 2027 using the same final results.

Takeaway: The final data strengthened the full-approval case; local reactions were the clearest adverse-event difference.

What comes next?

Vera Therapeutics (NASDAQ:VERA) is a clinical-stage biotechnology company focused on immunological diseases. Vera is studying atacicept, TRUTAKNA’s active ingredient and the company’s lead product candidate, in broader patient populations and has investigated its potential in other immune-mediated diseases. The biologic inhibits the B-cell survival factors BLyS and APRIL. Vera says its research targets underlying causes of autoimmune conditions rather than primarily addressing symptoms.

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.

Vera expected 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 were expected in the second quarter of 2027.

Takeaway: The next tests are commercial and clinical: recurring sales, full approval and whether monthly dosing offers another treatment option.