베라 테라퓨틱스(VERA) 2026년 3분기 실적 콘퍼런스콜: TRUTAKNA 출시 및 ORIGIN 3 결과

핵심 내용

• 베라 테라퓨틱스는 7월 7일 미국 식품의약국(FDA)의 가속 승인을 획득한 이후 첫 일부 분기 상업 판매가 반영된 2026년 3분기 TRUTAKNA 순제품 매출이 1,030만 달러를 기록했다고 발표했다.
• 회사는 11월 5일 기준 약 700건의 환자 시작 양식을 접수했다. 경영진은 처방 채택이 소수 의사에게 집중되지 않았으며, 1g 이상 및 1g 미만의 단백뇨 환자가 모두 포함됐다고 밝혔다.
• ORIGIN 3 임상시험에서 104주 차까지 연간화된 eGFR 기울기는 TRUTAKNA 투여군이 연간 -0.6mL/min, 위약군이 연간 -5.6mL/min으로 나타났다. TRUTAKNA는 신장 질환 진행 위험을 76% 낮췄으며 위험비는 0.24였다.
• 베라는 미국 내 완전 승인을 목표로 보완적 생물의약품 허가신청(sBLA)을 제출했다. 경영진은 2027년 중반에 FDA의 완전 승인을 받을 가능성이 있다고 보고 있으며, 2027년 1분기에는 유럽 판매허가신청을 제출할 계획이다.
• 3분기 순손실은 주로 TRUTAKNA 상업화 출시에 대한 투자로 인해 판매관리비가 6,140만 달러로 증가하면서 9,370만 달러(주당 1.30달러)로 확대됐다.
• 베라의 9월 말 기준 현금성 자산 및 시장성 유가증권은 3억 8,400만 달러였다. 10월 차입금 인출액 7,500만 달러를 포함한 프로포마 잔액은 4억 5,900만 달러였다.

주요 재무 데이터

사업 및 운영 실적

TRUTAKNA는 질환 진행 위험이 있는 성인 원발성 IgA 신증 환자의 단백뇨 감소를 위해 BAFF와 APRIL을 모두 표적하는 치료제로는 미국에서 최초로 승인받았다. 베라는 7월 7일 출시 이후 11월 5일까지 약 700건의 환자 시작 양식을 접수했다.

경영진은 초기 사용이 스테로이드, ACE 억제제 또는 ARB, SGLT2 억제제 등 기저 치료를 받던 기존 진단 환자군에서 주로 발생했다고 밝혔다. 다수의 환자는 이전에 FILSPARI 또는 TARPEYO를 투여받은 이력도 있었다. 의사들은 단백뇨 1g 미만 환자를 포함해 광범위한 환자군에 걸쳐 TRUTAKNA를 처방했다.

회사는 2만 9,000회 이상의 영업 방문을 완료했다. 초기 상업화 집중 대상은 처방량이 많은 신장내과 전문의와 대학병원 등 학술 기관이다. 또한 베라는 'TRUTAKNA 트루 서포트(TRUTAKNA Tru Support)'를 통해 보험 혜택 확인, 사전 승인, 이의 신청 및 재정 지원을 뒷받침하고 있다.

경영진은 3분기 제품 매출의 약 절반은 기저 수요, 나머지 절반은 재고 비축분에서 비롯됐다고 밝혔다. 회사는 향후 분기에서 수요 비중이 더 커질 것으로 예상하고 있다.

ORIGIN 3 임상 결과

성인 428명을 대상으로 한 ORIGIN 3 최종 유효성 분석은 사전에 지정된 모든 평가지표를 충족했다. 52주 차에 위약 보정 eGFR 이점은 5.6mL/min이었으며, 수치 변화는 TRUTAKNA 투여군이 -0.1mL/min, 위약군이 -5.7mL/min이었다.

104주 차까지 위약 보정 연간화 eGFR 기울기 이점은 5.0mL/min/year였다. 각 투여군의 기울기는 TRUTAKNA 투여군이 -0.6, 위약군이 -5.6이었다.

TRUTAKNA는 복합 신장 질환 진행 평가지표 위험을 76% 낮췄으며 위험비는 0.24였다. 30% 이상의 지속적인 eGFR 감소는 TRUTAKNA 투여 환자의 5%, 위약군 환자의 18%에서 나타났다. 위약군에서는 7명의 환자가 투석, 신장 이식 또는 사망으로 진행된 반면, TRUTAKNA 투여 환자 중에서는 해당 상태로 진행된 사례가 없었다.

104주 차에 위약 보정 UPCR 감소율은 60%였으며, 베이스라인에서 혈뇨가 있었던 TRUTAKNA 투여 환자의 97%에서 혈뇨가 소실됐다.

전반적인 이상반응 발생률은 TRUTAKNA 투여군이 75%, 위약군이 78%였다. 중대한 이상반응은 각각 7%와 15%로 보고됐으며, 이상반응으로 인한 투약 중단율은 각각 2%와 10%였다. 감염률은 유사한 수준이었고, TRUTAKNA 투여군에서 기회감염, 임상적으로 유의미한 저감마글로불린혈증 또는 사망 사례는 보고되지 않았다고 회사는 밝혔다.

파이프라인 확장

임상 2상 PIONEER 바스켓 임상시험에서 아타시셉트는 더 광범위한 IgA 신증 환자군에 걸쳐 24주 차에 단백뇨를 베이스라인 대비 52% 감소시켰다. 여기에는 eGFR이 20mL/min으로 낮은 환자, 단백뇨 1g 미만 환자, 신염을 동반한 IgA 혈관염 환자, 신장 이식 후 질환 재발 환자가 포함됐다.

항 PLA2R 양성 원발성 막성 신증 성인 환자 16명에서는 4주 차에 항체 감소가 확인됐으며, 초기 12주 동안 단백뇨가 감소했다. 베라는 또한 10세 이상 소아 환자를 등록 중이며, 향후 2~10세 아동으로 등록 대상을 확대할 계획이다.

경영진 전망

• 베라는 최근 제출한 sBLA의 규제 심사 결과에 따라 2027년 중반에 TRUTAKNA의 FDA 완전 승인이 가능할 것으로 예상하고 있다.
• 유럽의약품청(EMA) 산하 약물사용자문위원회와의 논의를 거쳐, 회사는 2027년 1분기에 유럽 판매허가신청을 제출할 계획이다.
• 경영진은 2026년 말까지 전체 보험 적용 대상 인구의 50%에 달하는 보험 급여 적용 확보를 목표로 하고 있다.
• 베라는 2026년 4분기 후반에 월 1회 아타시셉트 용량 설정 연구의 신규 코호트 데이터를 검토할 예정이다. 주 1회에서 월 1회로 투여 방식을 전환한 코호트의 결과는 2027년 2분기에 검토될 것으로 예상된다.
• 실적 발표 컨퍼런스 콜 기준, 특정 조건 충족을 전제로 회사의 대출 한도 중 최대 3억 5,000만 달러를 추가로 이용할 수 있는 상태다.

위험 요인 및 주시 분야

상업적 도입은 여전히 초기 단계다. 경영진은 신장내과 전문의들이 적격 환자를 식별하고 처방 접근 요건을 완료하며 TRUTAKNA 사용 경험을 쌓는 데 시간이 필요하다고 밝혔다. 또한 IgA 신증의 진단율이나 상병 코드 부여가 증가했는지 판단하기에는 아직 이르다.

보험자 정책은 지속적으로 수립되고 있다. 일부 정책은 FILSPARI나 VANRAFIA 같은 제품을 먼저 거치도록 요구하고 있으나, 경영진은 이러한 요건이 B세포 조절제 계열 약물 전반에 유사하게 적용된다고 설명했다.

초기 제품 매출의 약 절반은 실제 수요가 아닌 유통 재고에서 발생했으므로, 향후 처방 전환과 환자 치료 시작 건수가 출시 진행 상황을 가늠하는 중요한 지표가 될 것이다.

월 1회 투여 프로그램은 현재 평가 중이다. 경영진은 추가적인 세부 정보를 제공하기 전에 약동학, 약력학, 유효성 및 안전성 데이터를 내부적으로 검토할 것이라고 밝혔다. 아울러 향후 완전 승인 시 제품 라벨의 최종 문구 역시 FDA 심사 결과에 달려 있다.

애널리스트 Q&A 주요 내용

• ASN 이후 수요: 경영진은 ASN 키드니 위크 이후에도 견조한 속도로 수요가 지속되었으나, 변곡점을 확인하기에는 이르다고 말했다. 회사는 ORIGIN 3 발표가 4분기 활동을 뒷받침할 것으로 기대하고 있다.
• 처방의 저변: 약 700건의 환자 시작 양식은 소수 의사 집단에 의해 주도된 것이 아니었다. 베라는 처방 저변이 넓어진 점을 긍정적으로 평가하면서도, 더 구체적인 내용을 제공하기 전에 한 분기 데이터를 더 지켜보기를 희망한다고 밝혔다.
• 재처방 추이: 경영진은 재처방 환자 시작 양식 접수 시점이 IgA 신증 환자의 신장내과 내원 빈도에 부분적으로 달려 있다고 말했다. 초기 추적 관찰 내원과 검사 결과는 추가 처방을 뒷받침하는 요인으로 설명됐다.
• 면역글로불린 모니터링: 베라는 TRUTAKNA가 면역글로불린 모니터링을 필요로 하지 않는다고 밝혔다. ORIGIN 3 임상시험에서는 IgG 수치가 200 미만으로 2회 측정될 경우 투약을 중단하도록 되어 있었으나, 해당 기준치에 도달한 환자는 없었다.
• 향후 완전 승인 시 라벨 문구: 경영진은 완전 승인을 획득할 경우 GFR 및 신기능에 미치는 영향이 입증되지 않았다는 문구가 삭제될 것으로 예상하고 있다. 다만 FDA 심사가 진행 중인 만큼 그 이상의 구체적 전망에 대해서는 말을 아꼈다.
• 향후 공시 계획: 베라는 향후 실적 발표 컨퍼런스 콜 당일 기준이 아닌 마감된 각 분기 말 기준으로 환자 시작 양식 건수를 보고할 계획이다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good day, and welcome to the Vera Therapeutics Business Update and Financial Results Webcast for the quarter ended September 30. [Operator Instructions] As a reminder, this webcast is being recorded. If you have any objections, please disconnect at this time. I would now like to turn the call over to Josh Qin, Vice President of Corporate Finance and Investor Relations at Vera. Please go ahead.

Joshua Qin

Thank you, operator, and thank you, everyone, for joining us. Earlier today, we issued a press release announcing our business highlights and financial results for the quarter ended September 30, 2026. A copy of the press release is available in the Investors and Media section of our website at ir.veratx.com.

Before we begin, I would like to remind everyone that we will be making various remarks about future expectations, plans, and prospects, which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The company cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the SEC, including without limitation the company's most recent Form 10-K and Form 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

In addition, today's discussion includes results from ongoing clinical trials of atacicept in investigational uses that have not been approved by the FDA or any other regulatory authority. The full prescribing information for TRUTAKNA, including important safety information, is available on our website. Furthermore, the content of this webcast contains time-sensitive information that is accurate only as of the date of the live broadcast, November 5, 2026. Vera undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this broadcast. This webcast is being recorded and an archive will be available on our website for 30 days.

With that, I will turn the call over to Dr. Marshall Fordyce, Founder and Chief Executive Officer. Marshall?

Marshall Fordyce

Thank you, Josh, and welcome, everyone. Joining me today are Dr. Robert Brenner, our Chief Medical Officer; Matt Skelton, our Chief Commercial Officer; and Sean Grant, our Chief Financial Officer. The third quarter marked a major turning point for Vera. Following accelerated approval from the FDA in July, we launched TRUTAKNA, the first therapy approved in the U.S. that targets both BAFF and APRIL to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.

Since the accelerated approval of TRUTAKNA on July 7, we have received approximately 700 patient start forms to date. This early momentum exemplifies our longstanding confidence in TRUTAKNA's potential to become a foundational therapy for IgA nephropathy, and it represents an important first step in delivering on our commitment to people living with this disease. We're sharing this figure today because we believe it's the best measure of demand at this early stage of launch.

Moving forward, we expect net product revenue to become the primary indicator of progress in addition to quarterly patient start forms. The ORIGIN 3 final efficacy results presented at ASN Kidney Week in October strengthens the clinical foundation for this next phase of growth. As Rob will discuss, in the ORIGIN 3 final efficacy analysis, TRUTAKNA held the rate of kidney function decline to a physiologic level and reduced the risk of kidney disease progression by 76% compared with placebo through 104 weeks. We are pleased with the overall product profile and believe that we have one of the most robust data packages in the B-cell modulator class. These findings build on the proteinuria reduction at 36 weeks that supported accelerated approval.

This week, we submitted a supplemental biologics licensing application to the FDA, seeking full approval of TRUTAKNA in adults with primary IgA nephropathy based on the ORIGIN 3 final efficacy analysis. In addition, following a meeting with the Committee for Medicinal Products for Human Use at the European Medicines Agency, we plan to submit a marketing authorization application in the first quarter of 2027 for standard marketing authorization. Importantly, this application will leverage the same results presented at Kidney Week. These are important regulatory milestones as we advance toward potential full FDA approval in mid-2027, with potential approvals in other regions to follow.

Alongside the U.S. launch and our pursuit of full approval in the U.S. and other regions, we are advancing the ongoing development program to expand the opportunity for atacicept. This includes the Phase II PIONEER basket trial in broader IgA nephropathy populations and other antibody-mediated kidney diseases, including encouraging interim results presented at ASN, as well as the once-monthly dose range finding study. This integrated program reflects our ambition to build on our progress in adult IgA nephropathy and bring new treatment options to more patients over time.

With the early launch progress and expanding clinical evidence, Vera is now viewed as a leading kidney disease company. We are entering this next phase with enthusiasm and a clear focus on execution, bringing TRUTAKNA to more eligible patients today while developing opportunities to improve care for more patients in the future.

With that, I'll turn the call over to Dr. Robert Brenner for a recap of ASN and an update on our development activities. Rob?

Robert Brenner

Thank you, Marshall. Having spent the past few years working to advance atacicept through clinical development and U.S. regulatory approval, it is deeply rewarding to now see TRUTAKNA reaching patients. I want to recognize our colleagues across the organization for the strong start to the product launch and their commitment to helping patients access treatment. Vera is advancing the ongoing clinical development program with the objective to bring atacicept to more patients and broaden its potential across autoimmune kidney diseases. That work begins with pursuing full approval in adults with primary IgA nephropathy at risk for disease progression, supported by the ORIGIN 3 final efficacy results.

Two weeks ago, Dr. Jonathan Barratt presented the ORIGIN 3 final efficacy analysis as a late-breaking oral presentation in the opening plenary session of ASN Kidney Week with simultaneous publication in the New England Journal of Medicine. ORIGIN 3 randomized and dosed 428 adults with IgA nephropathy, and the final efficacy analysis met all prespecified endpoints. On the key secondary endpoint, the placebo-adjusted eGFR change from baseline at 52 weeks was 5.6 mL per minute. eGFR was minus 0.1 mL per minute with TRUTAKNA compared with minus 5.7 with placebo on top of background therapy. Through 104 weeks, the placebo-adjusted annualized eGFR slope was 5.0 mL per minute per year with minus 0.6 with TRUTAKNA versus minus 5.6 with placebo. The eGFR benefit observed with TRUTAKNA was preserved across all prespecified subgroups.

These data demonstrate that patients treated with TRUTAKNA lose kidney function at a physiologic rate of approximately minus 1 mL per minute per year, while patients on placebo and background therapy continue to lose eGFR at a pathologic rate and a high probability of developing kidney failure during their lifetime. TRUTAKNA also reduced the risk of the composite kidney disease progression endpoint by 76% compared with placebo through 104 weeks with a hazard ratio of 0.24, 11 patients on TRUTAKNA, or 5%, had a sustained decline in eGFR of 30% or more, compared with 38 patients, or 18%, on placebo. Zero patients on TRUTAKNA progressed to dialysis, kidney transplantation, or death compared with 7 patients on placebo.

At 52 weeks, the placebo-adjusted reduction in UPCR was 51%, and in galactose-deficient IgA1 was 67%, and hematuria resolved in 81% of TRUTAKNA-treated patients who had hematuria at baseline. And at 104 weeks, the placebo-adjusted reduction in UPCR was 60%, and hematuria resolved in 97% of TRUTAKNA-treated patients who had hematuria at baseline.

In the ORIGIN 3 final efficacy analysis, TRUTAKNA was well tolerated with a safety profile generally comparable to placebo. Overall adverse events occurred in 75% of patients on TRUTAKNA versus 78% on placebo. Serious adverse events occurred in 7% of patients on TRUTAKNA versus 15% on placebo, and adverse events leading to discontinuation occurred in 2% versus 10%, respectively. The most common adverse events associated with TRUTAKNA and placebo, respectively, were infections 51% versus 52%, and local administration reactions 30% versus 8% (sic) [ 5% ]. Infection rates were similar between the 2 arms. There were no opportunistic infections or clinically relevant hypogammaglobulinemia, and no deaths occurred in the TRUTAKNA group.

In the final efficacy analysis, 93% of TRUTAKNA-treated patients remained on therapy compared with 79% on placebo. These results form the basis of the recently submitted sBLA seeking full approval of TRUTAKNA in adults with primary IgA nephropathy, which is anticipated in mid-2027. ORIGIN 3 placebo participants are transitioning to open-label TRUTAKNA for the remainder of the trial. We reiterate our gratitude to the patients, investigators, employees, and collaborators who helped make this trial possible.

Next, I'll turn to PIONEER, a Phase II basket trial evaluating atacicept in broader IgA nephropathy populations and in other antibody-mediated kidney diseases. At ASN Kidney Week, Dr. Richard Lafayette presented interim results from the adult IgA nephropathy and primary membranous nephropathy cohorts as a late-breaking oral presentation. At the time of this interim analysis, the IgA nephropathy cohorts enrolled 101 adults with baseline characteristics distinct from what is studied in Phase III IgA nephropathy trials, including patients with eGFR as low as 20 mL per minute, patients with proteinuria below 1 gram, patients with IgA vasculitis with nephritis, and patients with recurrent IgA nephropathy after kidney transplantation. In these populations, atacicept reduced proteinuria by 52% from baseline at week 24, similar to the results from ORIGIN 3. Reductions were consistent across cohorts with low baseline eGFR, low baseline proteinuria, and IgA vasculitis with nephritis.

At the time of this interim analysis, the primary membranous nephropathy cohort had enrolled 16 adults with anti-PLA2R-positive disease, most of whom had nephrotic-range proteinuria. Reductions in anti-PLA2R antibody levels were detectable as early as week 4, and proteinuria declined over the first 12 weeks of treatment. These early data are consistent with what we would expect from a mechanism that acts upstream of autoantibody production.

In this interim analysis of PIONEER, the safety profile was consistent with the broader atacicept experience, with no adverse events leading to discontinuation and no opportunistic infections. We believe these results support continued investigation of atacicept in antibody-mediated glomerular diseases. Finally, in a separate poster, we outlined the PIONEER investigation of pediatric patients with IgA nephropathy. The trial is currently enrolling children aged 10 and older, and we expect to open enrollment to children aged 2 to 10 in the future. We will also be reviewing data from the ongoing monthly dose range finding study of atacicept later this quarter. Our goal is to build on the evidence in adult IgA nephropathy while pursuing the most promising opportunities to bring this important therapy to additional patient populations.

I'll now turn the call over to Matt Skelton to discuss our commercial progress. Matt?

Matt Skelton

Thank you, Rob. The TRUTAKNA launch is off to a strong start. As Marshall mentioned, we have received approximately 700 start forms since launch to date. We are encouraged by this early demand, which reflects both the significant unmet need in IgA nephropathy and the receptivity to the TRUTAKNA product profile. At the same time, we are just scratching the surface of the large potential for TRUTAKNA. As we have said from the outset, adoption will build over time as nephrologists identify appropriate patients, work through access requirements, and gain experience with TRUTAKNA. Our sales, market access, and patient support teams are working together to help eligible patients move from a treatment decision to starting therapy.

Beyond the safety and efficacy data, we believe that the experience of once-weekly self-administration at home with a small-volume autoinjector adds to TRUTAKNA's appeal for patients and physicians. Based on field feedback and over 29,000 sales calls to date, many patients like the ease of weekly at-home administration, while many physicians like the flexibility of weekly dosing should an adjustment be needed based on clinical judgment.

Helping eligible patients access treatment is a key launch priority. We are encouraged by the payer coverage policies taking shape. Our focus is on securing coverage that allows eligible patients to begin treatment without unnecessary delay. Through TRUTAKNA Tru Support, our patient support program, we are helping TRUTAKNA patients navigate insurance coverage, including benefit verification, prior authorization, and appeals, and are working to connect them with financial assistance options. Eligible commercially insured patients may pay as little as $0 out of pocket through our copay assistance program. And finally, our patient assistance program may provide TRUTAKNA at no cost to eligible uninsured or underinsured patients.

We are building a strong foundation for sustained growth by broadening adoption and expanding access for eligible patients. We are encouraged by the progress so far and confident in the opportunity ahead for TRUTAKNA. I'll now turn the call over to Sean to review our financial results. Sean?

Sean Grant

Thank you, Matt. I'll provide an overview of our financial results for the third quarter ended September 30, 2026. Additional details are available in today's press release and our Form 10-Q. Net product revenue from sales of TRUTAKNA was $10.3 million for the third quarter of 2026, our first partial quarter of commercial sales. Cost of sales was $3.3 million. Research and development expenses were $41.3 million for the third quarter of 2026, compared with $56.5 million for the same period in 2025. The decrease was primarily due to a reduction in contract manufacturing expenses recorded in research and development.

Following accelerated approval on July 7, 2026, manufacturing costs for TRUTAKNA commercial supply are now capitalized as inventory, whereas they were previously expensed as research and development. Selling, general and administrative expenses were $61.4 million compared with $27.5 million for the prior year period. The increase primarily reflected investment in the commercial launch of TRUTAKNA. Net loss for the quarter was $93.7 million, or $1.30 per share, compared with a net loss of $80.3 million, or $1.26 per share for the prior year period.

For the 9 months ended September 30, 2026, net cash used in operating activities was $305.9 million compared with $171.1 million for the prior year period, primarily reflecting increased investment in the commercial launch of TRUTAKNA. As of September 30, 2026, we had $384 million in cash equivalents, and marketable securities. In late October, we drew $75 million on our debt facility. On a pro forma basis, adjusting solely to reflect the October borrowing as if it had occurred on September 30, our balance of cash, cash equivalents, and marketable securities would have been $459 million.

As of today, up to $350 million remain available under our debt facility, subject to the satisfaction of certain conditions. Together, our cash resources and borrowing capacity provide the financial flexibility to support the TRUTAKNA launch and our ongoing trials. This concludes our prepared remarks. Operator, we are ready to open the call for questions.

Operator

[Operator Instructions] Our first question comes from Anupam Rama with J.P. Morgan.

질의응답

Joyce Zhou

Can you hear me now? Sorry.

Operator

Yes, indeed.

Joyce Zhou

This is Joyce on for Anupam. I know it's only been 2 weeks since ASN, but we were just wondering if there's been any early signs of pull-through in terms of demand or patient start forms after the final ORIGIN 3 presentation?

Marshall Fordyce

Yes. Matt, maybe you could answer that question for us.

Matt Skelton

Yes. The demand continues at a nice pace since ASN. It would be probably too early to see an inflection at this point. But we were super pleased with the Vera showing at ASN and think that, that's going to be a catalyst for us in Q4.

Operator

Our next question comes from Gavin Clark-Gartner with Evercore ISI.

Gavin Clark-Gartner

On the monthly data, so Rob, you noted in your prepared remarks that you will be seeing monthly data later this quarter. Are you expecting to present that data publicly? Or are you waiting for some additional data next year? Or are you waiting to have some more regulatory clarity before giving an update here? Really just overall, what is your level of confidence on the monthly program at this point?

Robert Brenner

Yes. Thanks for the question. The atacicept dose range finding study is ongoing. The study includes 3 different de novo monthly dose cohorts, a cohort switching from weekly to monthly dosing, and a control weekly cohort. We're going to be looking at all the data -- PK/PD, efficacy measures, and safety -- from the de novo cohorts with the analysis forthcoming with this quarter. And we'll be looking at the results from the switch cohort in Q2 of 2027. We're not very far away from having those data in hand. I think we'll stare into them internally, and then we'll have more to say after we've looked at the results.

Operator

Our next question comes from Ritu Baral with TD Cowen.

Ritu Baral

Can you hear me okay?

Marshall Fordyce

Yes, indeed.

Ritu Baral

I wanted to ask about -- questions for Matt specifically. What are you seeing now and maybe retrospectively in the last 3 months or so on trends of diagnosis in IgAN, now that there's 2 players in the market and disease awareness by at least 1 more? Are you seeing rising trends, increased diagnostic codes being utilized? And then my second question has to do about the current prescriber characteristics and call points. Can you walk us through how you're prioritizing call points and prescribers? Like, do you have tiering based on whether they're at centers of excellence versus community? Just that sequencing.

Matt Skelton

Sure. Ritu, yes, I think it would be too early for us to comment on if we're seeing increased diagnosis rates or coding. I think right now what we're seeing is we know that there's a large prevalent pool of patients that are already diagnosed with IgAN that are already receiving backbone treatments of IgAN. Those are the patients that we're seeing that are being moved to TRUTAKNA, and those are the ones we're discussing with nephrologists. As far as what the prescribers look like, what our call points are, in these early months, we're spending our time where the business is with the high decile physicians, 8, 9, 10 deciles. Also, we're in the academic centers as well. So that's been a real emphasis in these early months of launch.

Operator

Our next question comes from Pete Stavropoulos with Cantor Fitzgerald.

Unknown Analyst

Marshall, Sean, Rob, and Matt, this is [ Samantha ] on the line for Pete. Congrats on the early commercialization updates. Could you give us some more granularity on the types of patients represented in the patient start forms received to date? Are physicians initiating TRUTAKNA in a broad population or sticking to higher-risk patients? Trying to understand how broad of a population you are seeing adoption with, including patients closer to the KDIGO threshold of 0.5 grams per day.

Marshall Fordyce

Thanks for the question, [ Samantha ]. We're thrilled with the early momentum. And Matt, maybe I'd have you reiterate the indication statement breadth and maybe some color on what we're seeing early here.

Matt Skelton

I think we are seeing the benefits of the broad indication statement, Samantha. We're seeing patients with more than 1 gram of protein, and we're seeing patients prescribed that have less than 1 gram of protein. So we're pleased. I think it's a pretty broad swath we're seeing, and I think that mix will continue. And hopefully, we're tapping into what is currently viewed as less severe patients. So yes, but right now, a good mix.

Operator

Our next question comes from Rami Katkhuda with LifeSci Capital.

Rami Katkhuda

Congrats on the progress. I know it's still early, but what are you guys seeing in terms of prescriber breadth and depth? Are early TRUTAKNA prescriptions concentrated among a smaller number of high-volume nephrologists? Or are you seeing broader adoption with fewer prescriptions per physician?

Marshall Fordyce

Matt?

Matt Skelton

Yes, happy to take that. I'd like to get another quarter under my belt before we really start diving into depth and breadth, but we are pleased so far. The 700 patient start forms are not being driven by a small cohort of physicians. We feel good about the breadth to date.

Operator

Our next question comes from Mohit Bansal with Wells Fargo.

Mohit Bansal

A couple of questions, if I may. One is, have you disclosed out of the $10 million, how much was stocking versus the demand-driven sales? That's number one. And number two, you mentioned that there were no cases of clinically relevant hypogamma in Phase III trial. Would you be able to explain how it was defined and if there were cases falling below 300 during this trial. Congrats on the quarter.

Marshall Fordyce

Thanks so much, Mohit. Maybe Matt, first on the stocking question and then Rob, on the hypogamma handling.

Matt Skelton

Yes, I can start. Mohit, yes, about half of that is demand, about half is inventory. And we fully expect that ratio to go much higher for demand in the next quarters.

Robert Brenner

Yes. And in terms of hypogammaglobulinemia, we haven't seen clinically relevant hypogammaglobulinemia in the program. In ORIGIN 3, patients received their drug assignment without interruption and were not withheld due to their IgG levels. In the Phase III protocol, we used an IgG threshold below 200, and if there were 2 values below 200, there would be discontinuation of treatment. No patient reached that threshold. There has been no imbalance of infections across the program and no opportunistic infections.

Operator

Our next question comes from Vamil Divan with Guggenheim Securities.

Vamil Divan

Maybe just following up on that last question around immunoglobulin levels. Can you just share what you're seeing in terms of doctors as they start patients on this, or maybe broadly on these new B-cell modulators? Are they monitoring their patients' immunoglobulin levels? I know it's not required or mandated by the FDA, but I'm just curious if in the real world, if you're seeing any doctors doing that just as they get used to using these new products.

And then, Marshall, I just have a quick clarification question I'm getting from a couple of people. It sounds like going forward on the earnings updates, we should expect you'll give PSFs through the end of the prior quarter, not to the date of the call. Can you just clarify that's what you meant, and would you be providing any updates intra-quarter? Just getting a couple of people asking me that question. So maybe you can clarify.

Marshall Fordyce

Yes, happy to clarify that. Going forward, we'll use the quarter definitively moving forward. We think in this early stage, it's important to give an up-to-date view of demand in the early stage of launch. I would clarify that there is no monitoring required for the use of TRUTAKNA, and that's been true both in clinical as well as our experience out in the field with commercial utilization.

Operator

Our next question comes from Farzin Haque.

Farzin Haque

I wanted to get some more color on the PSFs. Like what is the split between the treatment-naive patients versus like switches off an existing agent? And within the switches, how much is coming off FILSPARI, TARPEYO and even VOYXACT for that matter?

Marshall Fordyce

Yes. Matt, I'll have you take that and just clarify what we mean by switch versus standard of care out there.

Matt Skelton

Farzin, these 700 PSFs are almost all from the prevalent patient pool. So these patients are on the backbone of therapy, be that steroids, ACE/ARB, SGLT2s. Many have been on FILSPARI and our TARPEYO. So that really is the patient that physicians are choosing to move onto TRUTAKNA at this point. I wouldn't -- and Marshall said it, I wouldn't call it switching. I think it's just almost a graduation and a move to a truly disease-modifying agent like TRUTAKNA.

Operator

Our next question comes from Dina Ramadane with Bank of America.

Dina Ramadane

Congrats on all the progress this quarter and the updates. Just 2 quick ones from us. Among physicians who have submitted 1 patient start form, what determines whether they progress to a second, third and so forth patient? Are repeat prescribers responding primarily to ease of access, patient experience with the autoinjector, early proteinuria measurements or confidence created by the final ORIGIN 3 data?

And second one, you guys previously described your access objective as parity with other products in the market. What does that mean in operational terms today, specifically across covered commercial lives? Like, what proportion of policies are permitting TRUTAKNA without a branded product step edit? And do those requirements differ from VOYXACT?

Marshall Fordyce

Matt, could you take that?

Matt Skelton

I'm happy to take that. I'll handle. On the covered lives, we're progressing well there. We're on track to meet a goal of 50% of covered lives by the end of the year. Any branded step-throughs that are out there with payers impact the B-cell class in the same way, and some of the branded step-throughs that are out there usually involve FILSPARI or VANRAFIA. But on the payer front, as each week goes by, we're seeing improvements, and we feel good about our progress there.

Regarding the physicians that have written or submitted a PSF, keep in mind, Dina, that a busy nephrologist for us in the community has 6, 7 IgAN patients. So one patient's start form, they may have just seen one of their IgAN patients since we've been on the market, right? So it's the rate at which IgAN patients are coming to the office. But there's nothing stopping them from writing that second. I think it's just the opportunity to use the product to get it.

What is a really rewarding part of -- we've been out there long enough now where many patients have come back in for a second visit once they've been on TRUTAKNA and are seeing fantastic results from the lab values. That is certainly a validation to the nephrologist and the patient of what TRUTAKNA can provide and certainly is a great stimulus for that second, third, and fourth patient start form.

Marshall Fordyce

I'll just add that this is a transformative product profile, and just presented at ASN and published in the New England Journal, looking at renal endpoints. These are data that we expect will be very impactful in terms of the launch going forward. So very encouraged by these early signs of a successful launch.

Operator

Our final question comes from Ryan Deschner with Raymond James.

Ryan Deschner

Congrats on the sBLA submission and strong early launch data. Curious on label expectations now that you've submitted your sBLA for full approval, how you're thinking about what data might make it onto the label, and what differences on the first page of the label you're expecting versus your accelerated approval label and how that thinking has evolved over time?

Marshall Fordyce

Yes. Rob, I'll have you take that.

Robert Brenner

Yes. So the accelerated approval is based on a proteinuria reduction endpoint, and the label calls out that the impact of TRUTAKNA on GFR and kidney function has not yet been established. Expectation is that with full approval now based on the GFR results, that language will be removed, and so the indication will be based on the impact on GFR and kidney function. There is precedent in product labels that have used composite kidney progression endpoints for that information to be in the label, and so we are thrilled that we've been able to move so quickly to submit the sBLA this month to the FDA, and we're eager to go through the review cycle with them. I really don't want to make any other comments about what the label might look like until we get further into that process.

Operator

This concludes our Q&A session. I will now turn the call back to Dr. Fordyce for closing remarks.

Marshall Fordyce

Thank you, operator. Just to close, we are proud of the progress we've made to date as a commercial-stage company. As we look ahead, our focus is on continuing to build out the TRUTAKNA launch, to advance toward potential full approval and developing atacicept for additional patients who need new treatment options. With that, I want to thank the patients, investigators, physicians, and the Vera employees who have made this progress possible. We're excited about the opportunity ahead and are committed to executing with urgency and with discipline. Thank you for your time and have a good day. We'll close the call now.