トラベア・セラピューティクス（TVTX）2026年第3四半期決算説明会：FILSPARIの売上高は2億20万ドルに到達

主要なポイント

• Travere Therapeuticsの2026年第3四半期の総売上高は、米国の製品売上高（純額）2億2,020万ドルを含めて2億2,460万ドルとなりました。
• FILSPARIの米国での製品売上高（純額）は、IgA腎症向け需要の継続および局所分節性糸球体硬化症（FSGS）適応症からの初の大きな貢献により、前年同期比約120%増の2億20万ドルに達しました。
• 同社はIgA腎症およびFSGS全体で、1,932件の新規患者開始フォーム（処方申し込み）を受領しました。経営陣は、順調な処方への移行と高い患者の服薬継続率（アドヒアランス）を挙げています。
• 第3四半期のFILSPARIの売上高のうち約800万ドルは専門薬局の在庫増加を反映したものでした。経営陣は、在庫の適正化に伴い、第4四半期の売上高が同程度減少すると予想しています。
• Travereは、2033年までにFILSPARIの年間売上高30億ドル以上を達成するという目標を維持しました。
• 2026年9月30日時点の現金、現金同等物および有価証券の残高は計4億7,180万ドルとなりました。経営陣は、現在の手元資金と拡大する収益基盤により、商業化およびパイプラインへの継続的な投資が可能であると述べています。

主要財務データ

事業・業績の動向

FILSPARIは引き続き成長の中心的ドライバーとなりました。経営陣によると、有料処方への移行と患者の服薬継続に支えられ、IgA腎症およびFSGSの両分野で堅調な需要がみられました。また同社は、FILSPARIがIgA腎症に対して最も多く処方されている承認薬であり続けていると述べています。

IgA腎症の新規治療開始の需要は第2四半期からわずかに減少しましたが、経営陣はこれを夏の季節性要因、前四半期の繰越需要、およびより動きの活発な治療市場によるものとしています。同社は引き続き、FILSPARIを免疫指向型治療に置き換わるものではなく、それらと併用可能な基礎的な腎臓標的療法として位置付けています。

FSGSの市販化は拡大を続けています。経営陣は、FSGS需要の前期比でのゆるやかな増加、処方医師の裾野の広がり、保険償還の進展を報告しました。当四半期に初めてFSGS向けに処方した医師の約40%は、IgA腎症に対してもFILSPARIを処方していました。FSGS向けにFILSPARIを処方した腎臓専門医の約3分の2は、発売以来1人のFSGS患者しか治療しておらず、既存の診療施設において更なる処方拡大の可能性があることを示しています。

小児患者はFSGSの商業的処方使用の最大約10%を占めており、これはDUPLEX試験の結果と一致しています。経営陣は、小児患者と成人患者の間でアクセス（薬剤の入手性）に実質的な差はないと報告しました。

米国腎臓学会（ASN）キドニー・ウィークにおいて、TravereはSPARTAN試験の2年間のデータを発表し、一次治療としてFILSPARI投与を受けた新規診断患者の75%が少なくとも1回は完全寛解を達成し、免疫抑制剤を使用せずに2年間にわたり腎機能が安定していたことを示しました。また、PROTECT試験およびDUPLEX試験の追加解析により、対象集団において対照療法と比較して蛋白尿の減少およびeGFR低下の緩やかさが裏付けられました。

FILSPARIにとどまらず、pegtibatinaseの第III相HARMONY試験における治験参加者の登録は大きく進展しました。Travereは引き続き2027年後半にトップライン結果を得ることを目指しています。また同社は、免疫介在性腎疾患における追加の用量評価および開発計画を支援するため、年内にcivorebrutinibの米国新薬臨床試験申請（IND）を提出する見込みです。

業績予想（ガイダンス）

経営陣は、IgA腎症およびFSGSにおける期待需要、有料処方への移行率、服薬継続率に基づき、2033年までにFILSPARIの年間売上高で少なくとも30億ドルを達成するという目標を維持しています。

2026年第4四半期のFILSPARI売上高は、約800万ドルの在庫適正化による逆風を受けると見込まれています。また同社は、第4四半期に割引率が上昇すると予想しており、通期のFILSPARIのグロス・ツー・ネット割引率は20%台半ばになると見込んでいます。

Travereは2027年にSPARX試験のデータを期待しており、2026年末までに第IV相SPARLGHT試験を開始する計画です。経営陣は、第III相HARMONY試験が2027年後半にトップライン結果を提供できると引き続き確信しています。

リスクおよび注視事項

• 動きが一段と活発化する市場の中で腎臓専門医が治療シーケンス（治療順序）や併用療法を評価するなか、経営陣はIgA腎症の新規患者開始数において四半期ごとの変動が生じると予想しています。
• 腎臓専門医の診療時間の奪い合いが新規患者開始のペースに影響を与える可能性がありますが、経営陣はFILSPARIの長期的な位置付けに自信を維持しています。
• 第3四半期のFILSPARIの売上高は、専門薬局における約800万ドルの高水準な在庫の恩恵を受けたため、第4四半期には同程度の売上減少が見込まれます。
• 第4四半期の割引率の上昇はFILSPARIの純売上高に影響を与え、通期のグロス・ツー・ネット割引率は20%台半ばになると見込まれます。
• FSGS市場での展開はまだ初期段階にあり、さらなる普及は医師の処方経験、保険支払者のポリシー更新、新規患者開始フォームから有料処方への移行にかかっています。
• エリック・デューブ（Eric Dube）CEOは12月に退任する予定であり、ブラッドリー氏（Bradley）が12月1日にTravereに入社する予定です。

アナリスト質疑応答の要点

経営陣は、FSGSにおける有料治療への移行がIgA腎症の初期ローンチ時よりも早く進んでおり、現在はIgA腎症の現在の移行タイムラインに近い水準にあると述べました。ほとんどの保険支払者は、すでにFSGS専用の給付対象方針にFILSPARIを組み込んでいます。

治療シーケンスについて、経営陣はIgA腎症患者を患者の約30%を占める高リスク群と、約70%を占める低リスク群に分類しました。高リスクの患者ほど併用療法を必要とする頻度が高くなると予想される一方、低リスク患者や未治療患者では、FILSPARIが腎標的療法としてより早期に使用される可能性があるとしています。

Travereは、新たな市場参入者が存在するにもかかわらず、FILSPARIからの切り替え率は一貫して低い水準にとどまっていると述べました。経営陣は、B細胞標的療法について、直接的な代替品ではなく、FILSPARIに追加される補完的な治療法と捉えています。

同社はまた、1日1錠の単一剤形と効果プロファイルに関する医師からのフィードバックを引き合いに出し、FILSPARIがIgA腎症において依然として優先的な位置付けにあるエンドセリン受容体拮抗薬であると述べました。経営陣は、患者に持続性の蛋白尿が認められる場合に、FILSPARIと免疫指向型療法を併用することに対して、保険支払者側からの実質的な抵抗感は報告されていないと述べました。

決算説明会文字起こし全文

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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 afternoon, and welcome to the Travere Therapeutics Third Quarter 2026 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to Ryan Hayes, Investor Relations Analyst. Please go ahead, Ryan.

Unknown Executive

Thank you, operator. Good afternoon, and welcome to Travere Therapeutics' Third Quarter 2026 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Peter Heerma, our Chief Commercial Officer; Dr. Jula Inrig, our Head of R&D and Chief Medical Officer; and Chris Cline, our Chief Financial Officer. Dr. Bill Roe, our Chief Research Officer, will join us for the Q&A.

Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement.

Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, November 2, 2026. and Travere specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. With that, let me now turn the call over to Eric.

Eric Dube

Good afternoon, and thank you for joining us today as we discuss another quarter of excellent execution and continued momentum across Travere's commercial business and pipeline.

Before turning to our results, I'd like to briefly reflect on my upcoming transition that was announced during the quarter. As I prepare to step down in December, I've been reflecting on the people and purpose that have shaped my time at Travere. Being part of this company has been the greatest privilege in my career, and I am deeply proud of what we've accomplished. I have never been more confident that Travere's best days are ahead with an exceptional executive team, life-changing therapies and a growing pipeline and an organization committed to delivering for patients.

I've been in regular communication with Bradley as we plan for him joining Travere on December 1. This time together has only strengthened my conviction that he is the perfect fit to lead Travere into its next chapter. He shares our commitment to patients and brings the experience, perspective and leadership to build on our momentum. We are approaching this transition from a position of strength, and you'll hear that reflected in the progress we're sharing today.

With that, let's turn to the advancements we've made for the quarter. The third quarter was marked by excellent execution across our business and continued progress against our 4 key pillars of our strategy to drive both near and long-term growth. As we enter the final months of the year and look ahead to 2027, I am very pleased with the momentum we have built and the increasingly durable growth profile of our company.

At the center of this momentum is FILSPARI, where strong patient demand, growing conversion and consistent commercial execution supported significant revenue growth across IgA nephropathy and FSGS. Quarterly net product sales surpassed $200 million for the first time, marking an important milestone as we continue to reach more patients. In IgA nephropathy, FILSPARI continues to demonstrate its foundational role with strong demand, steady conversion to paid prescriptions and consistently high patient adherence despite new market entrants.

Importantly, we are not simply adding new patients each quarter. We are building on a growing base of patients who remain on therapy over time. This dynamic is a powerful driver of recurring revenue and reinforces our confidence in FILSPARI's long-term growth potential. In FSGS, we remain encouraged by the early launch performance with high adoption trends consistent with our expectations. We're still at the beginning of this opportunity and see substantial potential to reach more eligible patients as nephrologists gain experience with FILSPARI, and Peter will provide additional details shortly.

This continued commercial momentum reinforces our confidence in achieving or exceeding more than $3 billion in annual FILSPARI sales by 2033. We've also made important progress strengthening FILSPARI's U.S. patent portfolio, including a recently issued patent directed at certain methods of use in IgA nephropathy and a notice of allowance for a patent application directed to certain methods of use in FSGS. The IgAN patent and upon issuance, the FSGS patent carry terms extending into 2037. Taken together, this commercial momentum and progress in our patent portfolio reinforce our belief in FILSPARI's potential to reach more patients and continue growing beyond 2033.

An important part of that long-term opportunity is reaching more patients earlier in their disease journey. We are also encouraged that earlier diagnosis and treatment of IgA nephropathy and FSGS are being recognized within the federal government through the recently published landmark HHS Kidney Care National Plan. For these rare kidney diseases, timely diagnosis can help physicians and patients consider appropriate treatment options earlier in the patient journey, reflecting more proactive kidney care. These developments reinforce our broader ambition to build a leading rare disease company with multiple opportunities for the long term.

Beyond FILSPARI, we are making tangible progress advancing the next growth opportunities for Travere. With the potential to become the first disease-modifying therapy for classical HCU, pegtibatinase represents an important opportunity to improve the lives of the estimated 7,000 to 10,000 people in the U.S. living with this devastating disease. Jim will share more on the progress of this important program shortly. We're also advancing our newest pipeline asset, civorebrutinib.

During the quarter, our licensing and collaboration agreement with Everest became effective, and our teams are making progress. Its potential differentiated profile and opportunity across multiple immune-mediated kidney diseases, representing more than 130,000 prevalent patients adds another compelling dimension to our long-term growth strategy.

As I look at Travere today, I see a company with a proven ability to execute, a growing and increasingly durable commercial franchise and a pipeline with multiple opportunities to deliver meaningful innovation. We have built the capabilities, relationships and expertise to lead in rare kidney disease, and we are only beginning to realize the opportunity ahead. With that, I'll turn the call over to Peter for an update on our commercial performance. Peter?

Peter Heerma

[Audio Gap] Sorry about that. Thank you, Eric. In the first quarter, we received 1,932 new patient start forms across IgA nephropathy and FSGS, reflecting continued strong and steady demand during a period when we typically see summer seasonality. We are pleased with this performance and the underlying dynamics of our business. We also continue to see strong conversion of new prescriptions to paid therapy and high patient adherence, allowing us to add meaningful numbers of new patients to an already substantial and growing base of patients on FILSPARI. The combination of our expected new patient demand, strong conversion and patient persistence now across two indications puts us well on track to achieve or exceed $3 billion in FILSPARI sales by 2033.

Let me start with providing some further color on IgA nephropathy. FILSPARI remains the most prescribed medicine approved for IgA nephropathy, reflecting its differentiated profile and foundational role in treatment. As additional therapies become available and this market evolves, physicians are increasingly considering how to sequence and combine treatment options. We believe FILSPARI is well positioned to remain an important part of these evolving treatment strategies. We continue to see new patient start forms coming from repeat prescribers as well as new physician activation.

The vast majority of FILSPARI prescriptions are for patients that have no prior experience with branded therapies. And market research indicate that FILSPARI is considered appropriate for more patients than any other branded IgAN medicine. This reflects the confidence that physicians have in FILSPARI's differentiated profile and how it is broadly applicable for their IgAN patients.

Within the dynamic and rapidly evolving treatment paradigm, we believe FILSPARI is well established as kidney-targeted treatment, replacing RAS inhibitors, consistent with the KDIGO guidelines. As new immune-directed therapies replace historical options, we expect these to address the immune-mediated processes upstream in the disease manifestation, while FILSPARI continues to provide kidney protection superior to maximally tolerated RAS inhibition. We believe these approaches will continue to be complementary for patients requiring proteinuria reduction and slowing disease progression.

Our conversations with physicians, most recently at the ASN Kidney Week reinforced their view of FILSPARI as a preferred kidney targeted medicine and a strong foundation for combination therapy, a pattern we are beginning to see in prescribing practice. We left ASN with even greater confidence in this positioning, and Jula will discuss the supporting clinical evidence shortly. We also see a particular opportunity among patients with proteinuria below 1.5 gram per gram. This segment represents approximately 70% of the IgAN population, and FILSPARI is well positioned to continue to penetrate this segment. This is also where we expect to see increasing biopsies, resulting in earlier diagnosis and a growing number of patients that can benefit from FILSPARI.

As the IgAN market is continuing to expand and as more companies increase their commercial activities, nephrologists are evaluating how to sequence and combine therapies amidst greater demands on their time and attention. We expect these dynamics to contribute in quarter-over-quarter variability in new IgA nephropathy patient starts, but we see an enduring fundamental role for FILSPARI, which reinforces our confidence in the substantial long-term opportunity in this patient population.

Turning to FSGS. We remain encouraged by the performance of the launch as we saw further strong demand during the third quarter. Our prescriber base expanded and nephrologists began treating additional patients within their practices. Approximately 40% of the first time FSGF prescribers during the quarter renewed to FILSPARI, expanding the brand's reach and creating additional opportunities in IgA nephropathy as well. We also see substantial opportunity to deepen prescribing within practices. Approximately 2/3 of the nephrologists who have prescribed FILSPARI for FSGS have treated just FSGS patient since launch.

FILSPARI's potential use spans eligible adults and children aged 8 and older without nephrotic syndrome, including patients with primary, secondary, genetic and unknown cause FSGS. Early prescribing has focused on patients with higher proteinuria across the segments. And as nephrologists gain experience, we expect broader use within practices, including among eligible patients with lower proteinuria similar to the evolution we have seen in IgA nephropathy. Our conviction is reinforced by what we hear from nephrologists about the important and broad role that FILSPARI should play in the treatment of FSGS. We expect that the availability of an approved treatment can encourage greater diagnostic evaluation, including biopsy and genetic testing when appropriate, helping to identify more patients who may benefit over time.

Access is advancing as most payers have already updated their coverage policies to include FILSPARI for FSGS, and we expect further progress through the end of the year. With strong demand and conversion since launch, we reported approximately $200 million in FILSPARI net product sales for the third quarter. Orders from our specialty pharmacy partners increased inventory above historical levels, and this contributed to approximately $8 million of the third quarter net sales. We expect fourth quarter net sales to be reduced by approximately the same amount as the specialty pharmacies will dispense existing stock to get back to normal levels.

Looking ahead, we see significant opportunities for FILSPARI as we remain in the early stages of reaching the more than 100,000 addressable patients with IgA nephropathy and FIGS. Our commercial focus remains on continuing to strengthen FILSPARI's position as kidney-targeted treatment, broadening our prescriber base and supporting physicians as they gain experience with FILSPARI to incorporate it more broadly into their practices. I am incredibly proud of our team and the impact they continue to have on patients and their physicians. With that, I'll turn the call over to Jula for the medical update. Jula?

Jula Inrig

Thank you, Peter. I'll start with FILSPARI, where new data presented at ASN builds on years of preclinical and clinical research, strengthening our understanding of its differentiated mechanism and foundational role across IgA nephropathy and FSGS.

Beginning with our preclinical work, we demonstrated that dual endothelin and angiotensin receptor blockade reduces pathogenic IgA deposition and mesangial cell proliferation while also protecting the glomerular endothelial glycolic and podocytes, key structures involved in maintaining the kidney filtration barrier. These findings have been supported by our clinical development program. In the randomized Phase III PROTECT study in IgA nephropathy, FILSPARI demonstrated superior proteinuria reduction and slower eGFR decline compared with maximally dosed irbesartan. Similarly, our new analysis of DUPLEX in patients with FSGS without nephrotic syndrome demonstrated greater proteinuria reduction and nominally significant slowing of eGFR decline.

At ASN, we also presented the final two-year results from SPARTAN, where newly diagnosed patients treated with FILSPARI as first-line therapy achieved substantial and sustained proteinuria reductions with 75% achieving complete remission at least once and stable kidney function over two years without immunosuppression. Biomarker analyses from SPARTAN also clearly demonstrated reductions in markers associated with inflammation and fibrosis.

Importantly, new analysis from the randomized Phase III PROTECT study confirmed the activity seen in SPARTAN. The results demonstrated reductions in biomarkers associated with macrophage activation, inflammatory and immune-mediated cytokines and complement-related pathways compared with irbesartan. Taken together, this growing body of evidence supports a broader understanding of FILSPARI's kidney targeted and disease-modifying mechanism, one that extends to address multiple pathways involved in kidney injury and disease progression without systemic immunosuppression.

Our recent interactions with nephrologists at scientific congresses reinforce the clinical importance of these findings. We are hearing growing recognition of FILSPARI's differentiated dual mechanism, particularly as treatment goals evolve towards complete remission of proteinuria and long-term preservation of kidney function. In FSGS, there's also increasing appreciation for FILSPARI's potential podocyte protective effects across different forms of the disease. Our new patient-reported outcomes analysis from DUPLEX further reinforce the clinical relevance of these goals, demonstrating an association between lower proteinuria and improvements in measurements of quality of life.

Looking ahead, we are advancing additional studies to further strengthen FILSPARI's evidence base across IgA nephropathy and FSGS. Enrollment is complete in SPARX, our study evaluating FILSPARI in patients with recurrent FSGS and IgA nephropathy following kidney transplantation, and we anticipate sharing data in 2027. We are also on track to initiate SPARLGHT later this year, a Phase IV study evaluating FILSPARI in adult and pediatric patients of African ancestry with FSGS who are at risk of disease progression.

Turning to pegtibatinase. Our medical affairs and clinical teams have expanded engagements with metabolic centers and investigators to support patient identification and enrollment in our Phase III HARMONY study. We have made substantial progress with enrollment, reinforcing our confidence in delivering top line results in the second half of 2027. Our conviction in pegtibatinase is supported by the Phase I/II COMPOSE study, which demonstrated approximately a 67% mean relative reduction in total homocysteine, the key toxic metabolite responsible for the multisystem complications of classical HCU. By addressing the underlying metabolic defect associated with CBS enzyme deficiency, pegtibatinase has the potential to become the first disease-modifying therapy for classical HCU, which would offer a meaningful new treatment option for patients living with this rare disease.

Finally, turning to civorebrutinib. We are making good progress advancing this exciting program towards U.S. clinical development. What attracted us to civorebrutinib is its potential to offer a differentiated approach to treating immune-mediated kidney diseases. While many current and emerging treatment strategies rely on broad immunosuppression or B-cell depletion, often requiring IV administration, civorebrutinib targets BTK signaling, a key pathway involved in B-cell activation and autoantibody production without directly depleting B cells. civorebrutinib is an oral, highly selective covalent reversible BTK inhibitor with the potential for rapid and sustained immune modulation.

Importantly, we've already seen encouraging clinical proof of concept in primary membranous nephropathy with rapid and substantial reductions in anti-PLA-2R antibodies, followed by meaningful reductions in proteinuria. We believe this combination of target mechanism, convenient oral administration and early clinical activity provides a compelling foundation for development across multiple immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS and minimal change disease.

We anticipate submitting a U.S. IND by year-end to support additional dose evaluation and inform our development strategy. In parallel, we're conducting study feasibility assessments and planning for future late-stage clinical studies with FDA engagement expected to help shape global development pathways across our priority indications. I'll now turn it over to Chris for the financial update. Chris?

Chris Cline

Thank you, Jula. Our third quarter results reflect continued strong execution with net product sales reaching a new high as we bring FILSPARI to more patients with IgA nephropathy and FSGS. Alongside this commercial progress, we continue to advance our pipeline during the quarter, building additional opportunities to serve patients and create long-term value alongside and beyond FILSPARI.

Starting with commercial performance. We generated $220.2 million in total U.S. net product sales in the third quarter. The significant increase in net product sales was driven by FILSPARI performance in the U.S. with building revenue from IgA nephropathy and the first significant contributions from the recently approved FSGS indication. U.S. net product sales of FILSPARI grew approximately 120% year-over-year to $200.2 million. From a gross to net perspective, FILSPARI had a onetime benefit of less than $2 million during the quarter.

And looking ahead, we continue to anticipate higher discounts in the fourth quarter and full year gross to net discounts for FILSPARI to be in the mid-20% range. THIOLA and THIOLA EC also contributed $20 million in U.S. net product sales during the third quarter. From a license and collaboration revenue perspective, we recognized $4.4 million for the quarter, resulting in $224.6 million in total revenue for the third quarter. Total GAAP R&D and SG&A expenses for the quarter were $168.7 million, which includes approximately $23.8 million in noncash stock-based compensation and depreciation expense. The year-over-year increase in R&D expense is primarily driven by increased enrollment in the Phase III HARMONY study and manufacturing activities for pegtibatinase during the quarter.

For SG&A, the year-over-year increase is primarily attributable to investments in FILSPARI's launch in FSGS, including the expanded field team as well as investments in our foundational positioning in IgA nephropathy. During the quarter, we recognized $113.1 million in IP R&D expense. This was related to the upfront payment of $112.5 million and related costs for the closing of the Everest licensing agreement that occurred in the third quarter. Royalty expense for the quarter was approximately $8 million, which reflects Thiola royalties expense for the quarter as well as the amortization associated with contractual milestones and royalty payments related to FILSPARI that are capitalized to intangible assets and amortized on a straight-line basis over the accounting line.

As of September 30, 2026, we had cash, cash equivalents and marketable securities of approximately $471.8 million. Our growing revenue base and strong cash position provide a solid foundation to support FILSPARI's continued growth and advance our pipeline with current resources. We will continue to invest with discipline, prioritizing opportunities that can make the greatest difference for patients and creating lasting value for our stakeholders.

Before turning the call back to Eric, I'd like to take a moment on behalf of the executive team to recognize his leadership and the strong foundation he has built at Travere. Eric, thank you for your partnership and your unwavering commitment to patients and a privilege to work with you. I'll now turn the call over to Eric for his closing remarks. Eric?

Eric Dube

Thanks, Bruce. As I reflect on the progress we've made this year, I am incredibly proud of what our teams have accomplished and the consistency with which they continue to execute. We have built a company with a growing commercial franchise, an exciting pipeline and the capabilities to deliver meaningful progress for patients. As Travere enters its next chapter, I have tremendous confidence in my colleagues and their ability to build on this momentum, creating a stronger future for the company and most importantly, for the rare disease communities we serve.

I want to close by returning to the HHS Kidney Care National Plan, which I believe reflects an important shift in how we approach kidney disease in this country. For the first time, rare kidney disease is receiving this level of federal attention with a focus on earlier detection and intervention. If we can translate that ambition into action, more patients with diseases like IgA nephropathy and FSGS could be diagnosed earlier and have the opportunity to benefit from treatment before irreversible damage occurs.

For Travere, this represents another potential source of long-term growth. But for patients and families, it represents something far more important, the possibility of earlier answers, more treatment options and a better future. That is what has always inspired our work at Travere, and it is why I am so confident in the company's chapter ahead. Thank you for your continued interest in Travere. And with that, operator, we can open the call up for Q&A.

Operator

[Operator Instructions] We will now take the first question from the line of Anupam Rama with JPMorgan.

質疑応答

Anupam Rama

This is Joyce on for Anupam. Congrats on the quarter. I know you've talked about conversion of patient start form to paid scripts in FSGS benefiting from having the IgAN approval, but naturally still taking a bit of time since it's still early in the launch. Could you talk about what you're seeing in terms of time to paid script for FSGS this quarter? And how is that tracking relative to your expectations?

Eric Dube

Great. Thank you so much for the question. And Peter, I'll turn that one over to you.

Peter Heerma

Yes, to take that question. What I had mentioned during the approval call of FSGS that we were expecting a faster uptake in conversion relative to the IgA nephropathy launch, and that's certainly what we are seeing. Very happy with that most of the payers have already included FILSPARI now in FSGS-specific formularies. And also, if I look at the time to conversion, we're almost at the same level as IgA nephropathy today. So very rapid progress. And I think the team is doing a fantastic job here.

Operator

Your next question comes from the line of Tyler Van Buren with TD Cowen.

Tyler Van Buren

Great. And Eric, congratulations on an incredible career and all of your accomplishments. With respect to the question, just -- so FILSPARI sales obviously look great. And obviously, that's of most importance. The seasonality of PSFs in Q3 was forecasted. But what have you seen in September, October? And what do you envision PSF growth to look like moving forward as you think about that translating to long-term sales growth and being a driver of revenue? And how do you envision the sequencing of new treatments in the IgAN market to progress?

Eric Dube

All right. Tyler, first, thank you very much for your kind words. And I think there are 3 questions. So I'm going to cover them first. We'll start with sort of the most recent. What are we seeing in October? What I would say for October is it's still early in the FSGS launch, and we're obviously seeing a lot of increased dynamism within the IgAN market, both of which we believe not only favor better treatment for patients, but also we think that we are very well suited for continued demand.

We're not going to be providing intra-quarter trends. What I would say is that we continue to see strong demand in both indications. And our metrics overall continue to support what we're hearing from nephrologists around their enthusiasm that continues for FILSPARI, even with the dynamics in the IgA nephropathy market. And importantly, as we look longer term, everything that we're seeing, including in October, are aligned with our long-term goals of achieving $3 billion by 2033. I think your second question, and Tyler, please correct me if I didn't capture it correctly, is what do we foresee in terms of demand moving forward? Is that right?

Tyler Van Buren

Yes.

Eric Dube

Okay. Yes. So as we think about moving forward, what I would say is just reinforcing the same aspect of the FSGS market, we're just getting started in terms of reaching these patients, educating nephrologists, activating patients. And also, there's a lot of evolution within IgA nephropathy. We're not going to be providing projections on patient start forms. What I can say is that we are very confident in our ability to continue to generate strong demand in both indications. If we look specifically at FSGS, we saw and expected a very rapid uptake that was not just some of the pent-up demand that we saw earlier. This was very much around the excitement of reaching patients and treating them with FILSPARI.

And we expect that, that accelerated adoption curve and then a sustained demand moving forward is very in line with our expectations. With IgA nephropathy, it's a very dynamic market. FILSPARI will maintain its foundational positioning. And we do expect that we're going to continue to see strong demand moving forward. But there will be some variability as nephrologists time just to meet with more companies is going to be constrained. These are all things that we've anticipated, but they do not undermine the strength and the outlook for FILSPARI. So I hope, Tyler, that gives you a sense of sort of how we're thinking about the evolution and the demand, and I'm sure Peter will speak more to that in the Q&A.

The third question was around patient segment. Is that right?

Tyler Van Buren

Yes, sequencing of new treatments.

Eric Dube

Yes. Okay. Patient sequencing. So this, I think, is maybe the most important that I want to convey because I've been doing this for decades. And I understand physician behavior and how they absorb new information and how that translates into behavior change. If there's one thing as I reflect on my career, I come at this very uniquely as a behavioral scientist. This is something that I really understand.

So let me share with you my perspective, and then I'll invite Peter and Jula to give any further color. When we look specifically at IgA nephropathy because sequencing really is around IgA nephropathy -- we look at two segments of patients. Those patients that are higher risk, and we've characterized that as about 30% of patients that are higher risk, oftentimes characterized by higher proteinuria levels above 1.5 grams and oftentimes have more rapid progression of eGFR.

Historically, those patients have been started initially with steroids or immunosuppressants because that's how nephrologists think about making sure that they can get these patients under control. Once they have that, that's where they begin to optimize kidney-directed care like FILSPARI and SGLT2s. That's been the sequencing that has taken place to date. And that likely is going to be the same, but B-cell therapies will replace and are replacing the historic roles of steroids.

When we look at the need for something like FILSPARI in the segment, these are the patients that need combination most. So ultimately, many of these patients as we forecasted and are starting to see are on that combination. And we hear the same thing probably that many of you do, that investors are hearing from nephrologists that the ideal combination moving forward is FILSPARI and SGLT2 and a B-cell therapy. These are the patients that need it most.

When we look at the second segment of patients, that's about 70% of patients, and they're lower risk, but still at risk of progression to kidney failure. This is where we've been growing most. And this is really where we are excited about the new evidence that Jula's team have generated showing that when you can reach patients earlier with FILSPARI, you have astounding results. 75% of patients get to complete remission if you can get these patients on FILSPARI before seeing a RAS inhibitor. And so we really do see that, that's likely going to be the sequence moving forward is getting patients kidney-directed care, get them under control. And for those patients that may need more, that may be where they're adding an immune suppressive therapy like a B-cell therapy.

But if we take a step back and we look at the outlook for FILSPARI in both of those segments, the sequencing may be different for some patients or how some nephrologists sequence differently. But at the end of the day, the combination of a B-cell therapy and FILSPARI is fully aligned with what the KDIGO guidelines now recommend and it gives us great confidence that we will play a very important role in better care for IgA nephropathy patients. Tyler, I know that was a very long question. Hopefully, I answer. Hopefully, I addressed your questions.

Operator

Our next question comes from the line of Laura Chico with Wedbush Securities.

Laura Chico

Congratulations, Eric. definitely going to miss you there. I guess, one, just related to the PSS question, a follow-up. Could you just clarify if you were seeing sequential growth in the IgAN segment on the PSS? And then Peter made a number of comments about the durability of patients on FILSPARI. Could you expand on perhaps how treatment duration looks like in FSGS thus far compared to IgAN at that point in the launch?

Eric Dube

Thanks so much, Laura. Yes, I'll hand those questions over to Peter.

Peter Heerma

Yes. Thanks, Laura, for that question. And we have commented earlier that we are not breaking out the performance by indication. Having said that, I want to give a little more color here. On FSGS, we saw a slight sequential growth from the second quarter to the third quarter. And while IgAN demand remained high, we saw a small decrease relative to Q2. I think that is consistent to our expectations, one, because of the summer seasonality, but also since we saw a little bit pent-up demand in the second quarter, and that's why I'm really pleased with the continuation of the sequential growth that we saw in the third quarter for FSGS.

I think Eric was talking earlier about the dynamic market of IgA nephropathy, where physicians are increasingly considering the sequencing and the combination therapy. And I think Eric clearly outlined the different patient segments that we see and how we think about the continuing opportunity for FILSPARI as a fundamental part of the treatment paradigm. And in FSGS, it's early in the launch. And we are seeing that across the different segments, I was mentioning in the prepared remarks, primary, secondary, unknown CARs, but also genetic that we see utilization across the different segments.

And as we saw in the initial IgAN launch, we also see the initial utilization in FSGS is for the higher proteinuria targets. But we see slowly moving that towards the left to like less high proteinuria targets. So very consistent to our expectations. And overall, I'm really happy with the strong demand that we saw in the third quarter.

Eric Dube

And the durability, Peter, do you want to talk a little bit more about what you're seeing in terms of the durability of patients on both.

Peter Heerma

Yes. I'm sorry, I missed that question, Laura. So overall, what I've spoken about in the past is the high compliance rate as well as the consistency and the persistence of patients on FILSPARI. We don't see changes in trends there, as you would expect because like other therapies are complementary and not competing with FILSPARI. With regards to the B cells, we often hear that this is added on top of FILSPARI rather than instead of FILSPARI, very consistent to the KDIGO guidelines and very consistent to our expectations.

Eric Dube

Yes. Thank you, Peter. And maybe one thing that I'll just add there because it's implicit, but I want to make it very explicit. We do not see a change in trend of switching away from FILSPARI. So you may have some baseline rate of switches, et cetera, over time. This has been consistently low even with the new entrants, which further reinforces that the likely sequencing and treatment algorithm is going to be combination, not switching from a kidney directed to immune, et cetera.

Operator

Your next question comes from the line of Joe Schwartz with Leerink Partners.

Joseph Schwartz

Thanks for the great leaders, Eric. Given the FILSPARI label goes down to age 8, we were wondering what share of FSGS start forms are pediatric now? And is pediatric access proving to be any different from adults on anything such as the gross to net or REMS logistics?

Eric Dube

Great question. Thanks, Joe. Peter, I'll turn those over to you.

Peter Heerma

Yes. Overall, I would say the utilization in pediatric patients is consistent to what we saw in the DUPLEX trial, up to 10% of the patients are pediatric, and that's what we see in the commercial utilization so far as well.

Joseph Schwartz

Yes. Any difference in access, Peter, or access to PNS?

Peter Heerma

No difference in access between pediatric and adult patients. I would say, overall, very happy with the rapid progress that our national account team has been made with payers, and we see utilization consistent to the label. And like I said, there's no difference between pediatric patients and adult patients.

Operator

Your next question comes from the line of Gavin Clark-Gartner with Evercore ISI.

Gavin Clark-Gartner

I'll add my congrats and well wishes to Eric as well. So we're just trying to back solve versus the revenue you reported. We're calculating around 80%, maybe a bit above 80% conversion rate for the FSGS PSS, which seems to be in line with other rare disease analogs. I know you're not reporting explicitly, but are you able to say if we're in the right range there?

Eric Dube

Yes. It's tough to be able to give you specifics because we are not commenting on some of those. But I would say it's largely within the range, and those things could evolve over time as we look at continuing growing access, et cetera. So what I would say just taking a step back is we are very pleased, and I'll just reinforce, Peter, I think what you said, which is the conversion rate that we're seeing now and time to conversion is close to reaching what we're seeing with IgAN. -- still some room to improve. We want to do everything possible, but largely in line. So maybe what you assume for IgAN is close to what we have for FSGS.

Operator

Your next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald.

Prakhar Agrawal

Congrats, Eric as well and my wishes to you. So maybe on 4Q as well, the trends that you're seeing, it seems like you have used dynamic and evolving IgAN market a few times in prepared remarks and Q&A. So, maybe if you can just comment on given what you're seeing in IgAN plus FSGS still early in the launch, do you still expect PFS to grow sequentially in 4Q? If you could just comment on that, that would be super helpful. And maybe secondly, on the pipeline, can you talk about sibeprenlimab and the next steps there and the indications that you are trying to prioritize?

Eric Dube

Sure. Thanks, Prakhar. I'll take the first one around what we are expecting for Q4. I'll have Jula talk about next steps for sibeprenlimab. Prakhar, I just want to remind that we don't provide guidance on PFS. I think with regard to -- which I know you're not specifically asking, but with regard to what's the magnitude of growth, we do believe that we have strong opportunity to continue to reach more patients, both with IgA nephropathy and with FSGS -- as I mentioned, we see strong demand in October.

Our teams, most importantly, this is about execution. How do we make sure that we continue every day to reach nephrologists and help them reach their patients, whether it's with IgA nephropathy or FSGS. So we've got two months to go. Peter's team is absolutely ready to make sure that we're doing all we can. And the opportunity is there and the trends are there. So I will leave it at that in terms of what our expectations are is our expectations are very strong for continued demand. But it's important also as we have a durable business that we continue to convert quickly and we keep these patients on.

All three of those things are very, very important as we think about the strong revenue outlook that we have for FILSPARI. I will reiterate that we could see variability quarter-to-quarter. But everything that we see thus far is very aligned with our internal planning assumptions. Peter, anything else that you want to comment on?

Peter Heerma

No, I think you commented well.

Eric Dube

Okay. Thanks, Peter. Jula?

Jula Inrig

Yes. Sibeprenlimab, our next step is to open the U.S. IND, and that's planned for this quarter. We're also planning and what that would enable us to do is to generate additional bridging PK/PD data and subsequently to align with the FDA on the development plans going forward. As I mentioned on the call, we're also working on feasibility and plans for our late-stage programs. And as we've said, membranous is likely going to be the first program because we have preclinical data. We're also prioritizing FSGS and minimal change disease. And based on the mechanism of action, we do have plans to develop an additional indications, but we haven't released those yet.

Operator

Your next question comes from the line of Yigal Nochomovitz with Citi.

Yigal Nochomovitz

This is Carolyn on for Yigal. You touched on KOL feedback regarding the ASN updates. Can you tell us more about how nephrologists are reacting to the 2-year SPARTAN results specifically? Do you believe these data increase the likelihood FILSPARI is used earlier following diagnosis?

Eric Dube

Thanks, Carolyn. Jula, why don't you take that question?

Jula Inrig

Yes. We were really pleased about the data we were able to present at ASN because it really supports the kidney targeted and disease-modifying effects of FILSPARI. And as you commented, the data resonated really well with nephrologists because they previously asked the research questions, where should we use different agents? Where should be FILSPARI be used? And this helps to support the utilization of FILSPARI earlier in the treatment paradigm with great outcomes.

As I mentioned on the call, you use FILSPARI in treatment-naive patients, even about 75% of patients to complete remission and stabilization of eGFR. That, in combination with the biomarker data, both from SPARTAN as well as PROTECT further solidifies you use FILSPARI earlier, you tend to have better outcomes in these patients. And that really does, as you've heard from Eric, use early, particularly in treatment-naive patients, you see even better outcomes, and that resonated quite well at ASN.

Operator

Your next question comes from the line of Sadia Rahman with Wells Fargo.

Sadia Rahman

Congrats on a great quarter and I also want to add my congratulations on your career, Eric. So my question is on the free drug programs for FILSPARI, the Quick Start and bridge programs that are being used, how they're being used in FSGS. And I think there was a recent change with extending that program to now 12 months. So just trying to understand how we should think about the rate of conversions with that program in place. Are you expecting that change to help convert more patients to paid drug?

Eric Dube

Thanks. Peter, I'll turn that one over to you.

Peter Heerma

Yes, happy to provide some further color on that one. We do have a free drug program, especially for patients early on in the launch as payers may not have yet evaluated the formularies for FSGS. This is consistent with how we have done for IgA nephropathy. To my earlier point, I mean, we see high levels of conversion to paid products. So -- but we also have a paradigm that no patient left behind. So every patient, we want to make sure that they have access to the drug and that it doesn't take too long because time is kidney. So we do have that program. But overall, I would say we see a strong trend of converting patient start forms to paid scripts. And yes, very pleased with that.

Operator

Your next question comes from the line of Alex Thompson with Stifel.

Alexander Thompson

Maybe another one about membranous nephropathy. I guess Parasol had a meeting back in September to discuss membranous nephropathy. I'm curious if Jula, you could provide some color on what was discussed and sort of what the next steps are for membrane nephropathy for Parasol.

Eric Dube

I'll turn it over to you.

Jula Inrig

Yes. Similar to the other Parasol projects, really the goal is to understand what biomarkers are associated with really the long-term kidney outcomes, whether it's GFR decline or kidney failure and essentially looking at proteinuria and then ideally to look at other biomarkers, phospholipase A2 antibodies, for example, -- it is earlier in the stage of this program with regards to looking at that. What they've seen is that clearly, proteinuria, as we know that's an agreed-upon endpoint with the agency does predict future declines in GFR decline and kidney failure. It's too early to say other biomarkers. That's partly because the data sets, they still need to aggregate them and bring them together to look at other endpoints that potentially could be used either for accelerated or for full approval. So more to come over time as more people generously donate some data to be able to look at this further.

Operator

Your next question comes from the line of Vamil Divan with Guggenheim Securities.

Vamil Divan

I hope you can hear me a little loud. The first question is on the IgAN space. And I'm just curious if you can talk about the ERA market share as we think about FILSPARI versus atrasentan and how that's evolved in the past year or so? And then my second question, one thing we were impressed by at ASN was just how even the patients on the APRIL/BAFF pretty significant residual proteinuria post after nine months or two years. So maybe you could just talk about how you see that evolving in terms of the need to keep giving something like FILSPARI on top of the APROLVAF over time on the proteinuria side?

Eric Dube

Thanks so much for the questions. Peter, why don't you take the first one on evolution of the ERA. And Julie, you can take one on the combination B-cell residual proteinuria. Peter?

Peter Heerma

Yes. Thanks, Ariel. I would say, overall, FILSPARI remains the preferred endothelin inhibitor across the IgA nephropathy patient population. What I frequently hear from physicians, most recently at the ASN Kidney Week is that one pill versus an add-on matters for patients and also the efficacy profile of FILSPARI versus atrasentan, I think, is beneficial for FILSPARI. So we see continued more utilization for FILSPARI relative to the alternative.

Eric Dube

Thanks, Peter. Jula?

Jula Inrig

Yes. And Vamil, thanks for that commentary. We know that proteinuria is bad. That's why it's agreed with the agency to be utilized as a biomarker for approval for patients with IgA nephropathy. And the RADR data says any proteinuria is bad. So that's why we -- the KDIGO guidelines have evolved to say, ideally, you get patients to complete remission of proteinuria to less than 0.3 grams per day.

And we know that no agent gets all patients there. As you commented, sibeprenlimab data at 2 years, about 22% of patients got to complete remission, at least a fair number of patients who still have residual proteinuria that puts them at risk for longer-term outcomes as well as the cardiovascular risk associated with having proteinuria. As I said earlier, if you use sibeprenlimab FILSPARI early in the treatment paradigm like we saw in SPARTAN, you get nearly 75% of patients into complete remission. But again, that's not 100%.

So the future paradigm, which is aligned with KDIGO is you're likely going to need to use combination therapies for these patients to reduce their lifetime risk of kidney failure as well as our long-term cardiovascular risk. So it is going to be important, and Eric highlighted the potential sequencing that may change over time and evolve, but it's really not that different. Patients at high risk and has residual proteinuria, they're likely going to need multiple agents to reduce their risk and FILSPARI offers the kidney-targeted nephroprotective benefit compared to a maximum dose irbesartan.

Operator

Your next question comes from the line of Jason Zemansky with Bank of America.

Jason Zemansky

Congrats on the progress. And Eric, it's been a pleasure working with you and best wishes on what's next. Maybe to connect a few of the previous thoughts on the sequential IAN trends you noted. appreciating no details, but qualitatively, can you speak to how much of this reflects seasonality and pent-up second quarter demand versus the multiple BAFAPRIL companies competing for a nephrologist time with new patients, including those below 1.5 grams who start on a APRIL/BAFF? And then maybe secondarily, for those patients who do need the added benefit of a kidney-sparing regimen, how challenging is it adding FILSPARI on top of the APRIL/BAFF, especially with payers? And is this going to be a barrier moving forward? And when does it sort of alleviate?

Eric Dube

Thanks so much for the comments, Jason, and the questions. Peter, why don't we go through the first, how are we seeing with regard to the Q3 versus Q2 on seasonality versus competing for time?

Peter Heerma

Yes. Very good, Jason. Thanks for the question. And I did write down 3 different questions. Let me try to answer that in the right order. So I mean, seasonality is a fact. We know that less FSGS and IgA patients see their physician during the summer months. We have seen it in the past. And so in that context, I think the number that we had on patient start forms, I'm actually very pleased with that. The other part of your question was like how many patients below 1.5 do you see FILSPARI relative to April and APRIL/BAFF. I would say where we see most utilization of the B cells is in the higher proteinuria levels.

And I think Eric was speaking to that earlier on as well. I think Jula was commenting on that. That means that in the sequencing as physicians are considering like how do I sequence and when do I combine -- some of those patients, a physician may decide to go initially to a B-cell, which doesn't mean that, that patient is not a FILSPARI candidate over time because to Jula's point, the vast majority of those patients still have residual high proteinuria. More specifically on your question, below 1.5, I think that's where FILSPARI has really made its inroads.

I mentioned in the prepared remarks that the vast majority of patients on FILSPARI, FILSPARI is the first branded therapy. So they are naive to therapies approved for IgA nephropathy. If you compare that to B cells, it's about half. So B cells are mostly added after they have tried other branded therapies. Your third part of the question was with regards to the payer and how does the payer have an appetite to reimburse FILSPARI after a B-cell, I would turn that around because you build upon a strong base of FILSPARI patients already.

And what I'm hearing, what I heard clearly at ASN, many of the B cells are actually added on top of FILSPARI. FILSPARI is still the preferred kidney-targeted medicine. And especially when you think about like early in the disease when FILSPARI is added, but they still don't have residual -- they still have residual proteinuria, they could add a B cell. So overall, I think reinforces what Eric said earlier about the patient segment, the sicker patient population, you may see initial sequencing on B cells. Those patients still remain a candidate for FILSPARI. We see that in practice, and we don't really see a pushback from payers. But more importantly, in the lower proteinuria target where most of the patients reside, over 70% of the patient population, FILSPARI has a very strong established position. And the first change physician makes is to change RAS inhibitor for FILSPARI. So I feel that we are strongly positioned there.

Operator

And our final question comes from the line of Maurice Raycroft with Jefferies.

Maurice Raycroft

I'll add my congrats, Eric, on your great tenure at Travere and wishing you all the best going forward. For FSGS, wondering if you can comment on the share of your FSGS patients who are on the 800 mg dose? And how quickly are patients titrating up to that dose? And what proportion of patients are able to maintain the 800 mg dose?

Eric Dube

Maury, thanks so much for the comments and the questions. Peter, I'll turn that last question to you.

Peter Heerma

Thanks, Eric, and Maury, thanks for that question. I would say it's still early in the launch, but what we are seeing so far and really pleased with like the compliance and the persistence, including the titration up to the 800 milligram where appropriate. Having said that, we also know that not all patients will stay on the 800. But overall, very pleased where we are, and I would say, consistent to what we saw in the DUPLEX study.

Operator

Ladies and gentlemen, this concludes the question-and-answer session of today's conference call. I'll hand the call back over to Ryan.

Unknown Executive

Thanks all for joining today's call. Have a great rest of your day.

Operator

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.