ベラ・セラピューティクス（VERA）2026年第3四半期決算説明会：TRUTAKNA上市とORIGIN 3結果

要点

• Vera Therapeuticsは、7月7日の米食品医薬品局（FDA）による迅速承認を受けて初の商業販売期間（四半期の一部）となった2026年第3四半期において、TRUTAKNAの製品純売上高が1,030万ドルに達したと発表した。
• 同社は11月5日時点で約700件の治療開始申請書を受領した。経営陣は、処方が一部の医師に偏ることなく普及しており、蛋白尿が1グラム超および1グラム未満の双方の患者が含まれていると述べた。
• ORIGIN 3試験では、104週時点での年間eGFR傾斜値がプラセボ群のマイナス5.6 mL/分/年に対し、TRUTAKNA群ではマイナス0.6 mL/分/年となった。また、TRUTAKNAは腎疾患の進行リスクをハザード比0.24、76%低減させた。
• Veraは米国での本承認（正式承認）を目指し、生物製剤承認一部変更申請（sBLA）を提出した。経営陣は2027年半ばにFDAからの本承認取得を見込んでおり、2027年第1四半期には欧州での販売承認申請（MAA）を計画している。
• 主にTRUTAKNAの商業化立ち上げへの投資に伴い販売費および一般管理費（SG&A）が6,140万ドルに増加したことから、第3四半期の純損失は9,370万ドル（1株当たり1.30ドル）に拡大した。
• Veraの9月末時点の現金同等物および有価証券の残高は3億8,400万ドルとなった。10月に実施した7,500万ドルの借入を含めたプロフォルマ残高は4億5,900万ドルであった。

主要財務データ

事業および業務の業績

TRUTAKNAは、病勢進行リスクのある原発性IgA腎症の成人患者において蛋白尿を減少させる、BAFFとAPRILの双方を標的とした米国初の承認治療薬となった。Veraは7月7日の発売から11月5日までの間に、約700件の治療開始申請書を受領した。

経営陣によると、初期の使用は主に、ステロイド、ACE阻害薬またはARB、SGLT2阻害薬などの基礎治療を受けている既存の確定診断患者群によるものであった。また、多くの患者が以前にFILSPARIまたはTARPEYOの投与を受けていた。医師らは、蛋白尿が1グラム未満の患者を含む幅広い患者層にTRUTAKNAを処方した。

同社は2万9,000件超の営業訪問（セールスコール）を完了した。商業展開の初期の注力対象には、処方数の多い腎臓病専門医や大学・研究機関などのアカデミックセンターが含まれる。また、Veraは「TRUTAKNA Tru Support」を通じて、保険給付の確認、事前承認、不服申し立て、経済的支援のサポートも行っている。

経営陣は、第3四半期の製品売上高の約半分が実需であり、残り半分が流通在庫によるものであったと説明した。同社は、その後の四半期においては実需の割合が拡大すると見込んでいる。

ORIGIN 3試験の臨床結果

ORIGIN 3試験の最終有効性解析は成人患者428人を対象とし、事前に規定されたすべての主要・副次評価項目を達成した。52週時点におけるプラセボ調整後のeGFRの改善効果（ベネフィット）は5.6 mL/分であり、変化量はプラセボ群のマイナス5.7に対し、TRUTAKNA群はマイナス0.1であった。

104週までの期間において、プラセボ調整後の年間eGFR傾斜値の改善効果は5.0 mL/分/年であった。それぞれの傾斜値は、TRUTAKNA群がマイナス0.6、プラセボ群がマイナス5.6であった。

TRUTAKNAは、複合腎疾患進行評価項目のリスクをハザード比0.24、76%低減させた。30%以上の持続的なeGFR低下は、TRUTAKNA群の5%に対し、プラセボ群では18%に認められた。また、透析、腎移植または死亡へと進行した患者は、プラセボ群の7人に対し、TRUTAKNA投与群では皆無であった。

104週時点で、プラセボ調整後のUPCR（尿蛋白/クレアチニン比）減少率は60%に達し、ベースライン時に血尿を有していたTRUTAKNA投与患者の97%で血尿の消失が認められた。

全有害事象の発現率は、プラセボ群の78%に対し、TRUTAKNA群では75%であった。重篤な有害事象はそれぞれ15%および7%で報告され、有害事象による投与中止は10%および2%であった。感染症の発生率は同等であり、同社によるとTRUTAKNA群では日和見感染症、臨床的に問題となる低ガンマグロブリン血症、または死亡例は報告されなかった。

パイプラインの拡充

第II相PIONEERバスケット試験において、アタシセプト（atacicept）は24週時点で、より広範なIgA腎症患者集団において蛋白尿をベースラインから52%減少させた。これには、eGFRが20 mL/分と低い患者、蛋白尿が1グラム未満の患者、腎炎を伴うIgA血管炎患者、および腎移植後の再発患者が含まれていた。

抗PLA2R抗体陽性の原発性膜性腎症の成人患者16人において、4週目までに抗体の減少が確認され、最初の12週の間に蛋白尿が減少した。Veraはまた、10歳以上の小児患者の登録も進めており、今後は2歳から10歳の小児へと登録を拡大する見込みである。

経営陣の見通し

• Veraは、最近提出したsBLAに対する規制当局の審査次第で、2027年半ばにFDAからTRUTAKNAの本承認を取得できる可能性があると見込んでいる。
• 欧州医薬品庁（EMA）のヒト用医薬品委員会（CHMP）との協議を経て、同社は2027年第1四半期に欧州での販売承認申請（MAA）を提出する予定である。
• 経営陣は、2026年末までに保険適用対象者（covered lives）の50%をカバーする保険適用の獲得を目標としている。
• Veraは、月1回投与のアタシセプト用量設定試験における新規（de novo）コホートのデータを2026年第4四半期後半に評価する予定である。週1回から月1回投与への切り替えコホートの結果については、2027年第2四半期に評価される見込みである。
• 決算説明会時点で、所定の条件を満たすことを前提に、同社の融資枠（デット・ファシリティ）の下で最大3億5,000万ドルが引き続き利用可能であった。

リスクと注視すべき点

商業的な導入・普及は依然として初期段階にある。経営陣は、腎臓病専門医が適格患者を特定し、保険アクセスの要件を満たし、TRUTAKNAの使用経験を積むには時間が必要だと述べた。また、IgA腎症の診断率や病名コーディングが増加したかどうかを判断するには時期尚早であった。

保険会社の適用基準（ペイヤー・ポリシー）は現在も策定が進められている。一部の基準ではFILSPARIやVANRAFIAなどのブランド薬によるステップ治療が義務付けられているが、経営陣はこれらの要件はB細胞調節薬クラス全体に同様の影響を与えると述べている。

初期の製品売上高の約半分は実需ではなく在庫によるものであったため、今後の処方への転換および新規治療開始数が、市場投入の進捗を測る重要な指標となる。

月1回投与プログラムは引き続き評価中である。経営陣は、詳細を公表する前に薬物動態、薬力学、有効性および安全性のデータを社内で精査すると述べた。また、本承認取得時の添付文書（ラベル）の最終的な文言もFDAの審査対象となっている。

アナリスト質疑応答の要点

• ASN後の需要： 経営陣は、米国腎臓学会（ASN）キドニー・ウィーク後も需要は順調なペースで推移しているものの、転換点を特定するには時期尚早であると述べた。同社は、ORIGIN 3試験の発表が第4四半期の活動を後押しすると見込んでいる。
• 処方医層の広がり： 約700件の治療開始申請書は、一部の医師グループのみによって牽引されたものではない。Veraは導入の広がりに手応えを感じているとしつつも、詳細を説明するにはもう1四半期分のデータが必要であると述べた。
• 反復処方： 経営陣は、治療開始申請書の再提出のタイミングは、IgA腎症患者が腎臓病専門医を受診する頻度に一部依存すると述べた。初期のフォローアップ受診や検査結果は、追加処方を後押ししていると説明された。
• 免疫グロブリンのモニタリング： Veraは、TRUTAKNAには免疫グロブリンのモニタリングは不要であると述べた。ORIGIN 3試験では、IgG値が200未満となった測定が2回続いた場合に投与中止と規定されていたが、その基準に達した患者はいなかった。
• 本承認時の添付文書の文言： 経営陣は、本承認が付与された場合、GFRおよび腎機能への影響が確立されていないとする記載が削除されると予想している。FDAの審査が進行中であるため、それ以上の見通しについての言及は控えた。
• 将来の情報開示： Veraは今後の治療開始申請書について、決算説明会の当日時点までではなく、完了した各四半期末時点までの数値を報告する予定である。

決算説明会 文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.