Travere Therapeutics Inc (TVTX) 2024 Q2 法說會逐字稿

Good day, and welcome to the Travere Therapeutics second quarter 2024 financial results and corporate update conference call.

美好的一天，歡迎參加 Travere Therapeutics 2024 年第二季財務業績和公司更新電話會議。

Today's call is being recorded.

今天的通話正在錄音。

At this time, I would like to turn the conference call over to the Vice President of Corporate Communications and Investor Relations, Nivi Nehra.

現在，我想將電話會議轉交給企業傳播和投資者關係副總裁 Nivi Nehra。

Please go ahead, Nivi.

請繼續吧，尼維。

Thank you, Rachel.

謝謝你，雷切爾。

Good afternoon and welcome to Travere Therapeutics second quarter 2024 financial results and corporate update call.

下午好，歡迎參加 Travere Therapeutics 2024 年第二季財務業績和公司更新電話會議。

Thank you all for joining.

感謝大家的加入。

Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube.

今天的電話會議將由我們的總裁兼執行長 Eric Dube 博士主持。

Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer; Peter Heerma, our Chief Commercial Officer; and Chris Cline, our Chief Financial Officer.

我們的首席醫療官 Jula Inrig 博士將與 Eric 一起發表準備好的演講； Peter Heerma，我們的首席商務官；和我們的財務長克里斯克萊恩。

Dr. Bill Rote, Senior Vice President of Research and Development will join us for the Q&A session.

研發資深副總裁 Bill Rote 博士將參加我們的問答環節。

Before we begin, I'd 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.

在我們開始之前，我想提醒大家，在這次電話會議中就非歷史事實的事項所做的陳述屬於 1995 年《私人證券訴訟改革法案》安全港條款範圍內的前瞻性陳述。

Forward-looking statements are not guarantees of performance.

前瞻性陳述並不保證業績。

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 statements.

它們涉及已知和未知的風險、不確定性和假設，可能導致實際結果、績效和成就與聲明中明示或暗示的結果、績效和成就有重大差異。

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.

請參閱今天稍早發布的公司新聞稿中的前瞻性聲明免責聲明以及我們向 SEC 提交的 10-Q 和 10-K 表格中的風險因素部分。

In addition, any forward-looking statements represent our views only as of the date such statements are made, August 1, 2024, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances.

此外，任何前瞻性陳述僅代表我們截至此類陳述發布之日（2024 年 8 月 1 日）的觀點，Travere 特別聲明不承擔更新此類陳述以反映未來資訊、事件或情況的義務。

With that, let me now turn the call over to Eric.

現在讓我把電話轉給艾瑞克。

Eric?

艾瑞克？

Thank you, Nivi, and good afternoon, everyone.

謝謝你，尼維，大家下午好。

In the second quarter, we continued to make significant progress on our key priorities.

第二季度，我們繼續在關鍵優先事項上取得重大進展。

At the center of our growth is FILSPARI, which is becoming a foundational therapy for IgA nephropathy, giving patients hope for a better future.

我們發展的核心是 FILSPARI，它正在成為 IgA 腎病的基礎療法，為患者帶來更美好未來的希望。

Our launch performance continues to strengthen.

我們的發布業績持續增強。

During the second quarter, we set new highs in demand and revenue, and we are on track to outperform benchmark launches in year two.

在第二季度，我們的需求和收入創下了新高，並且我們預計在第二年超越基準推出的產品。

FILSPARI is the only rare renal launch to consistently deliver quarter-over-quarter growth in new patient start forms through the first six quarters of launch, which speaks to high demand from physicians to patients and our ability to achieve our goals.

FILSPARI 是唯一一款在上市前六個季度持續實現新患者啟動形式持續季度增長的罕見腎臟產品，這說明了醫生對患者的高需求以及我們實現目標的能力。

This strength is being driven by positive trends in all of our key growth factors, including increasing breadth and depth of prescribers, strong payer coverage, and continuing improvements in our pull-through process.

這種優勢是由我們所有關鍵增長因素的積極趨勢推動的，包括處方醫生的廣度和深度的增加、強大的付款人覆蓋範圍以及我們拉動流程的持續改進。

From a regulatory perspective, our sNDA review process for full approval in IgAN continues as planned, and we are eagerly preparing for full potential approval next month.

從監管角度來看，我們在 IgAN 中獲得全面批准的 sNDA 審查流程仍在按計劃進行，我們正在熱切地為下個月的全面批准做好準備。

To date, our educational and promotional focus has been on the rapid and profound impact on proteinuria and the results from our interim readout from PROTECT.

到目前為止，我們的教育和宣傳重點一直是對蛋白尿的快速而深遠的影響以及我們從 PROTECT 中讀出的臨時結果。

We are excited about the opportunity to build further momentum in the launch that an updated label would provide, including the ability to educate on two-year data from the most rigorous study conducted in IgAN.

我們很高興有機會在更新標籤的發布中進一步增強動力，包括利用 IgAN 進行的最嚴格研究的兩年數據進行教育的能力。

We anticipate that a broader label would enable us to reach more patients.

我們預計更廣泛的標籤將使我們能夠接觸到更多患者。

Specifically, we estimate FILSPARI's addressable IgAN patient population in the future could nearly double over the time from the current level.

具體來說，我們估計 FILSPARI 未來可尋址的 IgAN 患者人數可能會比目前水準增加近一倍。

And the two-year data should build even more conviction in prescribing FILSPARI since it will potentially provide an opportunity for our teams to clearly highlight long-term durable proteinuria reduction, long-term kidney function preservation, and two-year safety data, and our teams are ready.

兩年的數據應該讓人們更確信 FILSPARI 的處方，因為它可能為我們的團隊提供一個機會，明確強調長期持久的蛋白尿減少、長期腎功能保存和兩年的安全數據，以及我們的研究結果。團隊已準備就緒。

We also continue to make progress in bringing FILSPARI to IgAN patients in other parts of the world.

我們也在將 FILSPARI 帶給世界其他地區的 IgAN 患者方面不斷取得進展。

Our partner in Europe, CSL Vifor is preparing for the first launch of FILSPARI in that region very soon.

我們在歐洲的合作夥伴 CSL Vifor 正在準備很快在該地區首次推出 FILSPARI。

In Japan, Renalys recently dosed the first patient in their pivotal study, which is expected to have results in the second half of 2025, and to support a submission to Japanese regulators for approval.

在日本，Renalys 最近在其關鍵研究中對第一位患者進行了給藥，預計該研究將於 2025 年下半年得出結果，並支持向日本監管機構提交申請以獲得批准。

As for the additional priorities to expand our growth, we are encouraged by the ongoing work regarding FSGS endpoints by the PARASOL Group.

至於擴大我們成長的其他優先事項，我們對 PARASOL 集團正在進行的有關 FSGS 端點的工作感到鼓舞。

And we remain hopeful that we will be able to identify a regulatory path to bring FILSPARI to patients diagnosed with FSGS.

我們仍然希望能夠找到一條監管途徑，將 FILSPARI 用於診斷為 FSGS 的患者。

We plan to engage with regulators later this year and to provide an update following those discussions.

我們計劃在今年稍後與監管機構進行接觸，並在討論後提供最新情況。

And finally, pegtibatinase continues enrollment activities in furtherance of a planned top-line readout in 2026.

最後，聚乙二醇化酶繼續進行招募活動，以促進 2026 年計劃實現的頂線讀數。

As we outlined at the start of the year, 2024 is a year of execution for Travere.

正如我們在年初所概述的，2024 年是 Travere 的執行年。

As we move into the second half of the year, I am proud of our teams and how they have continued to execute exquisitely across our priorities, all while keeping the needs of patients front of mind.

隨著我們進入下半年，我為我們的團隊以及他們如何繼續出色地執行我們的優先事項而感到自豪，同時始終將患者的需求放在首位。

I'll now turn the call over to Jula for an update on our development activities.

我現在將把電話轉給 Jula，以了解我們開發活動的最新情況。

Jula?

朱拉？

Thank you, Eric.

謝謝你，埃里克。

From a medical perspective, we continue to be focused on achieving full approval of FILSPARI and providing the education and support to enable FILSPARI to replace RAS inhibitors as foundational care for IgA nephropathy.

從醫學角度來看，我們繼續致力於實現 FILSPARI 的全面批准，並提供教育和支持，使 FILSPARI 能夠取代 RAS 抑制劑，作為 IgA 腎病的基礎護理。

I'm very pleased with the progress that we have made on both of these priorities during the quarter.

我對本季度我們在這兩個優先事項上取得的進展感到非常滿意。

We have long held the belief that the future of treatment in IgA nephropathy will be combination therapy, designed to address the overactivation in both the kidney and the immune system.

我們長期以來一直堅信 IgA 腎病的未來治療將是聯合治療，旨在解決腎臟和免疫系統的過度活化問題。

FILSPARI is unique in being a single pill that directly blocks two harmful pathways, endothelin and angiotensin, which are overactivated in the kidney and lead to kidney injury and IgA nephropathy.

FILSPARI 的獨特之處在於它是一種單一藥丸，可以直接阻斷兩種有害途徑：內皮素和血管緊張素，這兩種途徑在腎臟中過度激活，導致腎損傷和 IgA 腎病。

And we believe that FILSPARI, with its superior clinical profile addressing the overactivation in the kidney and providing long-term nephro protection will ultimately replace the use of RAS inhibitors, which have been the standard for addressing the damage in the kidney for decades.

我們相信，FILSPARI 以其卓越的臨床特徵解決腎臟過度活化問題並提供長期腎保護，最終將取代 RAS 抑制劑的使用，而 RAS 抑制劑幾十年來一直是解決腎臟損傷的標準。

We are seeing tangible signs of this evolution and a growing excitement within the nephrology community and among patients with IgA nephropathy.

我們看到了這種演變的明顯跡象，腎臟病學界和 IgA 腎病患者越來越興奮。

We recently attended an IgA nephropathy patient and caregiver conference and heard hope and inspiration through personal stories from patients on FILSPARI who now feel they have better control of their disease and a brighter outlook for the future.

我們最近參加了 IgA 腎病患者和護理人員會議，透過 FILSPARI 患者的個人故事聽到了希望和靈感，他們現在感覺自己可以更好地控制自己的疾病，並對未來有了更光明的前景。

We've seen a substantial shift this year in how nephrologists are speaking about and using FILSPARI for patients with IgA nephropathy.

今年，我們看到腎科醫生談論和使用 FILSPARI 治療 IgA 腎病患者的方式發生了重大轉變。

We hear more nephrologists referencing FILSPARI as foundational care in their practice, including initiating treatment with FILSPARI as a first-line therapy.

我們聽到越來越多的腎臟科醫生在實踐中將 FILSPARI 作為基礎護理，包括開始將 FILSPARI 作為一線治療。

At the heart of this momentum is our data.

這一勢頭的核心是我們的數據。

We have incredibly strong results from the most rigorous Phase 3 study completed in IgAN, one in which FILSPARI demonstrated superior results over an active comparator arm that significantly outperformed the placebo arm in other studies.

我們從IgAN 中完成的最嚴格的3 期研究中獲得了令人難以置信的強勁結果，其中FILSPARI 表現出優於活性比較組的結果，而活性比較組在其他研究中顯著優於安慰劑組。

And we've continued to generate additional data showing that if treated early with FILSPARI, patients can achieve proteinuria reductions of about 80% and stabilization of eGFR, and that FILSPARI can be used safely in combination with SGLT2 inhibitors.

我們持續產生更多數據，顯示如果早期使用 FILSPARI 治療，患者可以實現蛋白尿減少約 80% 和 eGFR 穩定，並且 FILSPARI 可以安全地與 SGLT2 抑制劑聯合使用。

This is why we're seeing physicians continue to upgrade their patients from RAS inhibitors to FILSPARI.

這就是為什麼我們看到醫生繼續將患者的 RAS 抑制劑升級為 FILSPARI。

And for those that need an additional treatment, they're combining FILSPARI with an SGLT2 inhibitor or steroid.

對於需要額外治療的患者，他們將 FILSPARI 與 SGLT2 抑制劑或類固醇結合。

This is aligned with the increasing recommendations in treatment guidelines and algorithms to replace RAS inhibitor therapy with FILSPARI in patients who remain at risk for progression.

這與治療指南和演算法中越來越多的建議一致，即在仍有進展風險的患者中以 FILSPARI 取代 RAS 抑制劑治療。

We believe the future for effective treatment of IgAN will call for diagnosing patients earlier and treating them with the goal of getting them into complete remission of their disease.

我們相信，未來 IgAN 的有效治療需要儘早診斷患者並進行治療，目標是讓他們的疾病完全緩解。

This will require simultaneous therapy, addressing both the overactivation in the kidney and the immune system.

這需要同時治療，解決腎臟和免疫系統的過度活化問題。

We expect FILSPARI will be part of the foundational kidney targeted therapy in that algorithm.

我們預計 FILSPARI 將成為此演算法中基礎腎臟標靶治療的一部分。

From a regulatory perspective, the sNDA process has been collaborative and is moving according to our expectations.

從監管角度來看，sNDA 流程一直是協作性的，並且正在按照我們的預期進行。

We are pleased with the interactions, and we look forward to our PDUFA date early next month.

我們對互動感到滿意，並期待下月初我們的 PDUFA 日期。

Upon full approval, we would anticipate a broader label for FILSPARI.

一旦獲得完全批准，我們預計 FILSPARI 將獲得更廣泛的標籤。

This would be grounded in the two-year PROTECT data that showed significant and durable reductions in proteinuria, kidney function preservation, including the slowest eGFR decline seen in a Phase 3 study, and an accrual of eGFR benefits, as well as robust safety data seen in our PROTECT study.

這將基於兩年的PROTECT 數據，該數據顯示蛋白尿顯著且持久地減少，腎功能得以保留，包括3 期研究中看到的最慢的eGFR 下降，以及eGFR 益處的累積，以及所看到的可靠的安全數據在我們的保護研究中。

Pending full approval, we believe these data will only further reinforce the nephroprotective effects of FILSPARI, providing further context and conviction for nephrologists to prescribe FILSPARI to more of their patients and to continue our progress towards FILSPARI achieving foundational care.

在等待完全批准之前，我們相信這些數據只會進一步加強 FILSPARI 的腎保護作用，為腎臟科醫生向更多患者開立 FILSPARI 處方並繼續我們在 FILSPARI 實現基礎護理方面取得進展提供進一步的背景和信念。

Now let me briefly discuss our efforts with FSGS.

現在讓我簡要討論一下我們與 FSGS 所做的努力。

As a reminder, in our Phase 3 DUPLEX trial, sparsentan demonstrated a statistically significant difference on the modified partial remission proteinuria endpoint and clinically meaningful improvements in kidney function and the composite kidney failure endpoints compared to irbesartan.

提醒一下，在我們的3 期DUPLEX 試驗中，與厄貝沙坦相比，sparsentan 在改進的部分緩解蛋白尿終點以及腎功能和複合腎衰竭終點方面具有臨床意義的改善方面顯示出統計學上的顯著差異。

And while we demonstrated a 0.9 mL per minute per year favorable treatment effect on chronic eGFR slope, there was considerable variability, so the eGFR endpoint was not achievable.

雖然我們證明了每年每分鐘 0.9 mL 對慢性 eGFR 斜率有良好的治療效果，但存在相當大的變異性，因此無法達到 eGFR 終點。

These data are important because a benefit on eGFR can't be statistically shown within a reasonable timeframe and sample size in a Phase 3 FSGS trial than another endpoint such as proteinuria needs to be proposed and validated.

這些數據很重要，因為在 3 期 FSGS 試驗中，無法在合理的時間範圍和樣本量內統計顯示 eGFR 的益處，而需要提出和驗證另一個終點（例如蛋白尿）。

With this background, NephCure, the FDA, EMA, and academia created an initiative called PARASOL with the goal of defining a better pathway to bring medicines to people living with FSGS.

在此背景下，NephCure、FDA、EMA 和學術界發起了一項名為 PARASOL 的計劃，其目標是確定更好的途徑，為 FSGS 患者提供藥物。

In order to accomplish this, PARASOL is compiling and analyzing data sets to define what should be the right endpoint in FSGS for regulatory approval.

為了實現這一目標，PARASOL 正在編譯和分析資料集，以確定 FSGS 中正確的終點以供監管部門批准。

We are grateful for the work this group is taking on and we continue to be optimistic that we can identify a path to approval for FILSPARI and FSGS.

我們感謝該小組正在進行的工作，並且我們仍然樂觀地認為我們能夠找到 FILSPARI 和 FSGS 的批准途徑。

We plan to engage with the FDA once the PARASOL results are available and expect to provide an update on our program later this year.

一旦 PARASOL 結果出來，我們計劃與 FDA 合作，並預計在今年稍後提供我們計劃的最新資訊。

Briefly, let me discuss our pegtibatinase program for patients with HCU.

簡而言之，讓我討論一下我們針對 HCU 患者的聚乙二醇化酶計劃。

We are excited about our potential to deliver pegtabatinase as the first disease modifying therapy for classical HCU.

我們對提供聚乙二醇化酶作為經典 HCU 的第一種疾病修飾療法的潛力感到興奮。

Our team recently attended an HCU patient summit and consistently heard encouragement and hope from patients and their caregivers around the pegtibatinase program.

我們的團隊最近參加了 HCU 患者高峰會，不斷聽到患者及其照護者對聚乙二醇化酶計畫的鼓勵和希望。

We remain on track with our enrollment targets to enable top line data in 2026.

我們仍將繼續實現我們的招生目標，以便在 2026 年實現營收數據。

In parallel, we continue to work on manufacturing scale-up to support the full Phase III program and commercial launch.

同時，我們繼續致力於擴大生產規模，以支援完整的第三階段計畫和商業啟動。

Let me now turn it over to Peter for a commercial update.

現在讓我把它交給彼得進行商業更新。

Peter?

彼得？

Thanks, Jula, and good afternoon, everyone.

謝謝朱拉，大家下午好。

In the first half of this year, we have been focused on delivering strong execution on FILSPARI launch, and I'm very proud of the progress that our teams has made across the board.

今年上半年，我們一直致力於為 FILSPARI 的發布提供強有力的執行力，我對我們的團隊在各方面取得的進展感到非常自豪。

We continue to see strong demand from physicians and their patients.

我們繼續看到醫生及其患者的強勁需求。

In the second quarter, we again achieved quarter-over-quarter growth and generated 521 new patient start forms or PSFs.

第二季度，我們再次實現了環比成長，並產生了 521 份新的患者起始表格或 PSF。

We have now demonstrated continued growth in new PSFs each and every quarter since the beginning of our launch and we are continuing to build momentum as we head towards our early September PDUFA date for full approval, which we believe will further accelerate FILSPARI's growth.

自推出以來，我們現在每個季度的新 PSF 都在持續成長，我們正在繼續增強勢頭，朝著 9 月初 PDUFA 獲得全面批准的日期邁進，我們相信這將進一步加速 FILSPARI 的成長。

Notably, new PSFs were generated both by a broadening of the prescriber base, as well as by further deepening of prescriptions by nephrologists.

值得注意的是，新的 PSF 是透過擴大處方者基礎以及腎臟科專家進一步深化處方而產生的。

By the end of the second quarter, approximately 2,400 nephrologists were REMS certified and we are exceeding recent rare nephrology benchmarks for the number of total prescribers after 18 months.

截至第二季末，大約 2,400 名腎臟病專家獲得了 REMS 認證，18 個月後我們的處方醫師總數超過了最近罕見的腎病學基準。

We believe one of the key drivers of this continued growth is that, we are continuing to hear from FILSPARI prescribers that their patients are experiencing what we saw in clinical trials, the rapid and sustained reduction in proteinuria with a well-tolerated safety profile.

我們相信，這種持續增長的關鍵驅動力之一是，我們不斷從FILSPARI 處方者那裡聽到，他們的患者正在經歷我們在臨床試驗中看到的情況，蛋白尿快速持續減少，且安全性良好。

As more nephrologists adopt FILSPARI, they are having this positive experience with their patients, and we are pleased that they then become advocates for using FILSPARI with their peers.

隨著越來越多的腎臟科醫生採用 FILSPARI，他們在患者身上獲得了這種積極的體驗，我們很高興他們隨後成為與同行一起使用 FILSPARI 的倡導者。

Product access and reimbursement is strong with 96% of the US lives having a pathway to FILSPARI reimbursement, and we are very pleased with the claims approval rates we are seeing, also reflecting the strong authorization criteria for FILSPARI payer plans and formularies.

產品取得和報銷能力很強，96% 的美國人可以透過 FILSPARI 報銷途徑，我們對所看到的索賠批准率感到非常滿意，這也反映了 FILSPARI 付款人計劃和處方集的嚴格授權標準。

We are also driving additional efficiencies in our pull-through process, which is supporting our increasing prescriber base and the growing number of patients initiating therapy having a positive experience with FILSPARI.

我們也正在提高拉動流程中的效率，這支持了我們不斷增加的處方者基礎以及越來越多開始治療並獲得 FILSPARI 積極體驗的患者。

All of these efforts have resulted in $27.1 million of net FILSPARI sales in the second quarter, an increase of 37% over the first quarter.

所有這些努力使得 FILSPARI 第二季淨銷售額達到 2,710 萬美元，比第一季成長 37%。

I am really pleased with this inflection in revenue as it positions us to outperform recent rare nephrology revenue benchmarks in the second year of launch, especially with strong catalysts ahead of us.

我對收入的這種變化感到非常高興，因為它使我們能夠在推出的第二年超越最近罕見的腎臟病收入基準，特別是在我們面前有強大的催化劑的情況下。

As we look ahead, the most important catalyst is our upcoming PDUFA date next month.

展望未來，最重要的催化劑是下個月即將到來的 PDUFA 日期。

As Jula mentioned, we are preparing for a full approval with a broadening of the FILSPARI label, which if granted, we believe will allow for an acceleration of demand based on two factors.

正如 Jula 所提到的，我們正在準備擴大 FILSPARI 標籤的全面批准，如果獲得批准，我們相信基於兩個因素將加速需求。

We believe that a potential wider indication statement coupled with our further data initiatives and nephrologist evolution towards earlier treatment of IgAN patients will have the potential over time to increase the addressable IgAN patient population from approximately 30,000 to 50,000 patients to up to 70,000 patients.

我們相信，潛在更廣泛的適應症聲明，加上我們進一步的數據措施和腎病專家對IgAN 患者早期治療的發展，隨著時間的推移，有可能將可尋址的IgAN 患者人數從約30,000 至50,000名患者增加到多達70,000 名患者。

Alongside this, with a full approval and updated label, we would expect to finally be able to educate physicians on our exciting two-year data from the most rigorous pivotal trial conducted in IgA nephropathy to date.

除此之外，透過全面批准和更新標籤，我們希望最終能夠向醫生提供迄今為止在 IgA 腎病中進行的最嚴格的關鍵試驗中令人興奮的兩年數據。

Thus far, our uptake has been largely driven by the results from the interim analysis, so we expect the two-year confirmatory data will further support foundational use of FILSPARI in daily practice.

到目前為止，我們的採用很大程度上是由中期分析結果推動的，因此我們預計兩年的驗證性數據將進一步支持 FILSPARI 在日常實踐中的基礎使用。

We are ready, prepared, and fully energized to leverage this anticipated milestone to elevate FILSPARI.

我們已做好準備並充滿活力，利用這一預期的里程碑來提升 FILSPARI。

Preparations are underway to position our teams to engage with patients and physicians to amplify the profile of FILSPARI on full approval.

我們的團隊正在準備與患者和醫生接觸，以在完全批准後擴大 FILSPARI 的知名度。

Additionally, we anticipate that the new KDIGO guidelines will become available soon, timing that is potentially lining up quite nicely.

此外，我們預計新的 KDIGO 指南將很快推出，時機可能會非常好。

We anticipate that for the first time they will include FILSPARI as part of the treatment paradigm, that they will emphasize the urgency to diagnose and treat IgA nephropathy patients earlier with a more ambitious proteinuria treatment targets.

我們預計他們將首次將 FILSPARI 作為治療範例的一部分，他們將強調透過更雄心勃勃的蛋白尿治療目標儘早診斷和治療 IgA 腎病患者的緊迫性。

This would provide an opportunity to broaden the addressable patient population.

這將為擴大可尋址患者群體提供機會。

I couldn't be more proud of the progress that our talented and dedicated teams have made in the first half of this year.

我對我們才華橫溢、敬業的團隊在今年上半年的進步感到無比自豪。

These accomplishments provide a solid framework to strengthening the FILSPARI profile and broadening the addressable patient population in the second half of the year.

這些成就為加強 FILSPARI 形象並擴大下半年的可治療患者群體提供了堅實的框架。

We are driven by the prospects of serving even more patients moving forward by establishing FILSPARI as the foundation therapy for IgA nephropathy patients.

我們希望透過將 FILSPARI 確立為 IgA 腎病患者的基礎療法，為更多患者提供服務。

Let me now turn the call over to Chris for a financial update.

現在讓我把電話轉給克里斯，了解最新的財務狀況。

Chris?

克里斯？

Thank you, Peter, and good afternoon, everyone.

謝謝你，彼得，大家下午好。

During the second quarter, we continue to have strong operational performance led by a significant increase in net product sales and reduced operating cash use.

在第二季度，由於淨產品銷售額大幅成長和營運現金使用減少，我們繼續保持強勁的營運業績。

Net product sales for the second quarter of 2024 grew to $52.2 million compared to $29.5 million for the same period in 2023.

2024 年第二季的產品淨銷售額成長至 5,220 萬美元，而 2023 年同期為 2,950 萬美元。

This increase of approximately 77% is attributable to growth in net product sales from the ongoing US launch of FILSPARI and IgA nephropathy.

約 77% 的成長歸因於 FILSPARI 和 IgA 腎病變在美國的持續上市帶來的產品淨銷售額的成長。

During the quarter, we also recognized $1.9 million of licensing collaboration revenue, which results in $54.1 million in total revenue reported for the period, compared to $32.2 million in the same period in 2023.

在本季度，我們也確認了 190 萬美元的授權合作收入，這使得該期間報告的總收入為 5,410 萬美元，而 2023 年同期為 3,220 萬美元。

Research and development expenses for the second quarter of 2024 were $54.3 million, compared to $66.5 million for the same period in 2023.

2024 年第二季的研發費用為 5,430 萬美元，而 2023 年同期為 6,650 萬美元。

On a non-GAAP adjusted basis, R&D expenses were $50.6 million for the second quarter of 2024, compared to $59.5 million for the same period in 2023.

根據非公認會計原則調整後的基礎上，2024 年第二季的研發費用為 5,060 萬美元，而 2023 年同期為 5,950 萬美元。

Selling, general and administrative expenses for the second quarter of 2024 were $64.8 million, compared to $68.2 million for the same period in 2023.

2024 年第二季的銷售、一般及管理費用為 6,480 萬美元，而 2023 年同期為 6,820 萬美元。

On a non-GAAP adjusted basis, SG&A expenses were $48.3 million for the second quarter of 2024, compared to $49.7 million for the same period in 2023.

根據非公認會計準則調整後的基礎上，2024 年第二季的銷售、管理及行政費用為 4,830 萬美元，而 2023 年同期為 4,970 萬美元。

The decline in year-over-year operating expenses is attributable to the restructuring enacted at the end of 2023 and reduced clinical expense as the sparsentan Phase 3 studies advance towards completion.

營運費用較去年同期下降的原因是 2023 年底實施的重組以及隨著 Spasentan 3 期研究接近完成而臨床費用的減少。

Total other expense net for the second quarter 2024 was $1.9 million compared to total other net income -- other income net of $2.1 million in the same period of 2023.

2024 年第二季的其他支出淨額總額為 190 萬美元，而 2023 年同期的其他淨收入總額為 210 萬美元。

The difference is largely attributable to a $3.4 million noncash charge to other expense related to the Renalys collaboration announced earlier this year.

差異主要歸因於今年稍早宣布的與 Renalys 合作相關的其他費用 340 萬美元的非現金費用。

Net loss, including from discontinued operations for the second quarter of 2024 was $70.4 million, or $0.91 per basic share, compared to a net loss of $85.6 million, or $1.13 per basic share for the same period in 2023.

2024 年第二季的淨虧損（包括終止經營業務）為 7,040 萬美元，即每股基本股 0.91 美元，而 2023 年同期的淨虧損為 8,560 萬美元，即每股基本股 1.13 美元。

On a nonadjusted basis, net loss, including from discontinued operations from the second quarter 2024 was $50.1 million, or $0.65 per basic share, compared to a net loss of $60.1 million, or $0.79 per basic share for the same period 2023.

在未經調整的基礎上，淨虧損（包括自2024 年第二季起終止營運的業務）為5,010 萬美元，即每股基本股0.65 美元，而2023 年同期的淨虧損為6,010 萬美元，即每股基本股0.79 美元。

As of June 30, 2024, the Company cash, cash equivalents and marketable securities of $325.4 million.

截至2024年6月30日，公司現金、現金等價物及有價證券為3.254億美元。

Cash used during the second quarter included approximately $71 million of previously disclosed milestone payments and approximately $45 million of operating cash use.

第二季使用的現金包括先前揭露的約 7,100 萬美元的里程碑付款和約 4,500 萬美元的營運現金使用。

Importantly, operating cash use declined by approximately $20 million in the quarter, and further declines in the second half of the year are expected, as well as throughout 2025 and beyond.

重要的是，本季營運現金使用量減少了約 2,000 萬美元，預計下半年以及 2025 年及以後將進一步下降。

This is driven by expected growth in FILSPARI sales, continued contribution from Thiola, and declining R&D investment in sparsentan over time as the supporting studies complete.

這是由於 FILSPARI 銷售額的預期成長、Thiola 的持續貢獻，以及隨著支持研究的完成，sparsentan 的研發投資隨著時間的推移而下降。

We also anticipate multiple incoming milestone payments from CSL Vifor upon conversion of FILSPARI to full approval in Europe and market access achievements.

我們也預計，在 FILSPARI 轉換為歐洲完全批准並取得市場准入成果後，CSL Vifor 將收到多項里程碑付款。

With these elements, we continue to believe that our balance sheet can support current operations into 2028.

有了這些因素，我們仍然相信我們的資產負債表可以支援目前的營運直至 2028 年。

I'll add one administrative note, alongside the filing of our 10-Q today, we're also filing a new shelf registration statement with the SEC.

我將添加一份行政說明，除了今天提交的 10-Q 之外，我們還將向 SEC 提交一份新的擱置註冊聲明。

This is a housekeeping measure as our current shelf registration statement is set to expire on September 3.

這是一項內部管理措施，因為我們目前的貨架登記聲明將於 9 月 3 日到期。

With that, I'll now turn it back to Eric for his closing comments.

現在，我將把它轉回給埃里克，讓他發表結束語。

Eric?

艾瑞克？

Thank you, Chris.

謝謝你，克里斯。

Through the first half of 2024, we've delivered meaningful growth in FILSPARI, continued the collaborative engagements with regulators and payers, and have made meaningful progress in bringing both FILSPARI and pegtibatinase to patients.

到 2024 年上半年，我們實現了 FILSPARI 的顯著增長，繼續與監管機構和付款人合作，並在將 FILSPARI 和聚乙二醇化酶帶給患者方面取得了有意義的進展。

We know that they are waiting for us.

我們知道他們在等我們。

It's for this reason that I and my colleagues at Travere have executed with focus and passion this year.

正是出於這個原因，我和我在 Travere 的同事們今年專注且熱情地執行工作。

We are well-positioned to achieve further progress in the remainder of the year, which should position Travere for meaningful growth now and in years to come.

我們有能力在今年剩餘時間內取得進一步進展，這將使 Travere 在現在和未來幾年實現有意義的成長。

Now, let me turn the call over to Nivi for Q&A.

現在，讓我將電話轉給 Nivi 進行問答。

Nivi?

尼維？

Thank you, Eric.

謝謝你，埃里克。

We can now open up the line for Q&A.

我們現在可以開通問答熱線。

Rachel?

雷切爾？

(Operator Instructions) Tyler Van Buren, TD Cowen.

（操作員說明）Tyler Van Buren，TD Cowen。

Hey, guys.

嘿，夥計們。

Thanks very much for taking the question and congratulations on the quarter.

非常感謝您提出問題並對本季表示祝賀。

Regarding a potential removal or modification of the REMS upon a full approval next month, can you just remind us what you guys suggested to the FDA as we think about the potential scenarios and outcomes?

關於下個月完全批准後可能刪除或修改 REMS，您能否提醒我們，在我們考慮潛在的情況和結果時，你們向 FDA 提出了哪些建議？

Well, certainly, Tyler, thank you for the question.

嗯，當然，泰勒，謝謝你的提問。

I'd say, first, let me share that we believe that this is the first natural opportunity for us to engage with the FDA with the additional data for reviewing for full approval.

我想說，首先，讓我分享一下，我們相信這是我們與 FDA 合作並獲得額外數據以進行全面批准審查的第一個自然機會。

And there is, as you know, no precedent for something being changed this early in approval, and that the process requires us engaging with multiple divisions within the agency.

如您所知，在批准過程中如此早期進行更改是沒有先例的，並且該過程需要我們與該機構內的多個部門合作。

And I think with that said, we certainly are looking at multiple scenarios, including a modification, potential removal.

我認為話雖如此，我們當然正在考慮多種方案，包括修改、可能的刪除。

But again, both of those -- there is not much precedent this early or that there would be a continuation for liver monitoring as it stands.

但同樣，這兩點——這麼早就沒有太多先例，也沒有多少先例可以繼續進行肝臟監測。

What we've guided previously is that, we're committed to putting our best foot forward during this sNDA review and to provide an update at full approval.

我們先前的指導是，我們致力於在 sNDA 審查期間盡最大努力，並在完全批准後提供更新。

And what I'd say with regard to the scenarios is, we're ready for anything.

關於場景我想說的是，我們已經做好了一切準備。

If we take a step back and independent of where we are with this process, I'm really proud of our ability to demonstrate strong growth and performance in FILSPARI with the REMS.

如果我們退一步，不管我們在這個過程中處於什麼位置，我真的很自豪我們有能力透過 REMS 在 FILSPARI 中展示強勁的成長和業績。

So regardless of where we land with this process in the near-term, we can expect significant growth moving forward given that FILSPARI is now becoming the foundational therapy for the treatment of IgAN.

因此，無論我們短期內這一進程的進展如何，鑑於 FILSPARI 目前正在成為 IgAN 治療的基礎療法，我們都可以預期未來會顯著增長。

Anupam Rama, JPMorgan.

阿努帕姆‧拉瑪，摩根大通。

Hey, guys, thanks so much for taking the question.

嘿，夥計們，非常感謝您提出這個問題。

Just a quick one for me.

對我來說只是一個快速的。

When you think about patient start forms and what you're seeing, how much of that can you attribute to, say, new prescribers versus repeat prescribers?

當您考慮患者開始表格和您所看到的情況時，您可以將其中的多少歸因於新處方者與重複處方者？

And how has that changed over time?

隨著時間的推移，情況又發生了怎樣的變化？

Thanks so much.

非常感謝。

Great.

偉大的。

Thanks, Anupam, for the question.

謝謝阿努潘提出的問題。

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

彼得，我會把那個交給你。

Yes, overall, I think we see a nice continuation of growth, both from -- both the broadening of the prescriber base, as well as the deepening.

是的，總的來說，我認為我們看到了良好的持續成長，既來自於處方者基礎的擴大，也來自於處方者基礎的深化。

I think that's exactly what you would expect.

我認為這正是您所期望的。

I would say, it's almost equal on if you look at like the increase in patient start forms where it comes from new prescribers, as well as existing prescribers.

我想說，如果你看看來自新處方者和現有處方者的患者起始表格的增加，這幾乎是相同的。

So I think a very nice trajectory, and I think very much in line with the best practices I've seen in the past for successful launches.

所以我認為這是一個非常好的軌跡，而且我認為非常符合我過去看到的成功發布的最佳實踐。

Joseph Schwartz, Leerink Partners.

約瑟夫‧施瓦茨，Leerink Partners。

Thank you.

謝謝。

Congrats on a strong quarter.

恭喜季度表現強勁。

Based on the sales for the quarter and our estimate for price, it seems like there's just over 1,100 patients on therapy by the end of the quarter.

根據本季的銷售額和我們對價格的估計，到本季末似乎只有 1,100 多名患者正在接受治療。

I was wondering, is that estimate reasonable.

我想知道，這個估計合理嗎？

And given the company has received over 2,400 PSFs since -- or as of the end of the quarter, could you talk a bit about how much success you're having converting PSFs to scripts?

鑑於該公司自此以來（或截至本季末）已收到超過 2,400 個 PSF，您能否談談您在將 PSF 轉換為腳本方面取得了多大成功？

How long does that take?

這需要多長時間？

And how should we think about that cadence of conversions over the balance of the year?

我們該如何看待今年剩餘時間的轉換節奏？

Joe, thanks so much for the question.

喬，非常感謝你的提問。

And Peter, I'll turn this one also over to you.

彼得，我也把這個交給你。

Yes.

是的。

Thank you, Joe. I think it's a good question.

謝謝你，喬。我認為這是一個好問題。

I would say, first, our strong inflection in growth in net revenue in the second quarter is a reflection of the continuing efficiencies that we're making in the fulfillment process.

我想說，首先，我們第二季淨收入成長的強勁變化反映了我們在履行流程中持續提高效率。

What you're speaking to is like the cumulative number of patients start forms.

你所說的就像是患者開始表格的累積數量。

And as we mentioned at the earlier call, last summer we observed a pocket of patients that required additional support and education, in particular in the REMS certification process.

正如我們在早些時候的電話會議中提到的，去年夏天我們觀察到一些患者需要額外的支持和教育，特別是在 REMS 認證過程中。

But the measures we made and implemented allow for better patient engagement on this REMS certification process.

但我們制定和實施的措施可以讓患者更好地參與 REMS 認證流程。

And I would say within that context, I'm really pleased with the progress we are making.

我想說，在這種情況下，我對我們正在取得的進展感到非常滿意。

And see, we are well within the rare disease benchmarks, both on the amount of patients that we are serving, as well as the time to fill two paid shipments.

看吧，無論是在我們服務的患者數量上，還是在填充兩批付費貨物的時間上，我們都完全符合罕見疾病的基準。

Thanks, Peter.

謝謝，彼得。

And Joe, I'll just reiterate that I'm really pleased with how those efficiencies have been going and how Peter's team has been executing.

喬，我只想重申，我對這些效率的進展以及彼得團隊的執行方式感到非常滿意。

I think the fundamentals that we're seeing in Q2 and into Q3 are exactly where I'd hope to be going into full approval, where we really are seeing those operational efficiencies of pull through and conversion happening.

我認為我們在第二季和第三季看到的基本面正是我希望得到完全批准的地方，我們確實看到了拉動和轉換發生的營運效率。

Great.

偉大的。

That's very helpful.

這非常有幫助。

Thanks.

謝謝。

And then a question on pegtibatinase, if I could, how has site activation been going and enrollment up until this point?

然後是關於聚乙二醇化酶的問題，如果可以的話，到目前為止網站激活和註冊進展如何？

Jula, why don't you take that one?

朱拉，你為什麼不拿那個？

Thank you.

謝謝。

So we're pleased to have the first patient dosed earlier this year.

因此，我們很高興今年早些時候對第一位患者進行了給藥。

And as I mentioned on the call, we really have a strong interest from patients in the community, and this is both in the US and abroad.

正如我在電話中提到的，社區患者確實對我們產生了濃厚的興趣，無論是在美國還是國外。

As I've previously mentioned in the past, we're metering enrollment to ensure we have strong quality and can scale up for CMC for the full study and commercial launch.

正如我之前提到的，我們正在計量註冊人數，以確保我們具有強大的質量，並可以擴大 CMC 的規模，以進行全面的研究和商業發布。

We've said before we're not going to provide specific patient numbers along the way, but our goal and we're planning for top line data in 2026.

我們之前說過，我們不會一路提供具體的患者人數，但我們的目標和計劃是在 2026 年提供頂線數據。

Thank you.

謝謝。

(Operator Instructions) Carter Gould, Barclays.

（操作員說明）Carter Gould，巴克萊銀行。

Great.

偉大的。

Thanks for taking the question.

感謝您提出問題。

Maybe to tackle the guidelines from a little bit of a different angle.

也許可以從不同的角度來處理這些指導方針。

Upon the guidelines being announced, what's your expectation that then like the timeframe from that announcement to payer policy and language being updated?

準則公佈後，您對從公告到付款人政策和語言更新的時間範圍有何期望？

Thank you.

謝謝。

Carter, thanks for the question.

卡特，謝謝你的提問。

Peter, I'll hand that one over to you.

彼得，我會把那個交給你。

Yes, thanks, Carter.

是的，謝謝，卡特。

First of all, I think you're referring to the KDIGO guidelines and (inaudible) actually part of the script that we are expecting that soon.

首先，我認為您指的是 KDIGO 指南，並且（聽不清楚）實際上是我們預期的腳本的一部分。

And I would say timing could be better.

我想說時機可能會更好。

Lowering the proteinuria target really positioned FILSPARI well, given our strong proteinuria efficacy data, 50% absolute reduction, as well as our complete remission data.

鑑於我們強大的蛋白尿療效數據、50% 的絕對降低率以及我們的完全緩解數據，降低蛋白尿目標確實使 FILSPARI 處於有利位置。

And additionally, this lower treatment will also allow to broaden the patient population.

此外，這種較低的治療也將擴大患者群體。

So we are really excited about the momentum that this generates for FILSPARI.

因此，我們對 FILSPARI 所產生的動力感到非常興奮。

With regards to the second part of your question, how fast will payers adopt this in their plans?

關於你問題的第二部分，付款人將多快在他們的計劃中採用這一點？

Well, we are ready to go with our updated value proposition with payers from under the FILSPARI profile.

好吧，我們已準備好向 FILSPARI 設定檔下的付款人提出更新的價值主張。

And when payers are in their payer plans are not only referring to the label, but also to guidelines.

當付款人參與其付款計劃時，不僅參考標籤，還參考指導方針。

So I'm really excited that those are coinciding quite nicely in the time.

所以我真的很興奮，因為這些在當時非常吻合。

I think it provides a great opportunity for our clinical national account managers to have that conversation with payers and to update the authorization criteria very quickly.

我認為這為我們的臨床國民客戶經理提供了一個與付款人進行對話并快速更新授權標準的絕佳機會。

Jason Zemansky, Bank of America

傑森‧澤曼斯基，美國銀行

Good afternoon.

午安.

This is Pavan Patel on for Jason Zemansky.

我是帕萬·帕特爾 (Pavan Patel) 為傑森·澤曼斯基 (Jason Zemansky) 配音。

Congrats on the quarter.

恭喜本季。

And thanks so much for taking our questions.

非常感謝您回答我們的問題。

With the PROTECT data in hand, could you please highlight the feedback that you've been getting from prescribers?

有了 PROTECT 數據，您能否強調一下您從處方者那裡得到的回饋？

What's thus far been the biggest hurdles to uptake in the community and academic settings?

迄今為止，社區和學術環境中最大的障礙是什麼？

And then, as you think about the likely potential label update, what factors do you think could be the most critical or impactful in terms of driving uptake?

然後，當您考慮可能的潛在標籤更新時，您認為哪些因素在推動採用方面可能是最關鍵或最有影響力的？

And then in terms of the sales trajectory for FILSPARI, do you expect patient inflection to be immediate in conjunction with the label -- the broader label update, or more gradual without seeing an early bullish?

然後就 FILSPARI 的銷售軌跡而言，您是否預期患者的變化會與標籤一起立即發生——更廣泛的標籤更新，還是在沒有看到早期看漲的情況下更加漸進？

Thank you.

謝謝。

All right.

好的。

Thank you for those questions.

謝謝你提出這些問題。

And Peter, why don't you take those?

彼得，你為什麼不拿走那些？

Yes, I'm happy to take those.

是的，我很高興接受這些。

And the first question is really, like, what are PROTECT is resonating most?

第一個問題是，PROTECT 最能引起共鳴的是什麼？

If full disclosure, like, given that we don't have the full label, we are not able to talk commercially about eGFR and long-term kidney preservation data.

如果完全揭露，例如，考慮到我們沒有完整的標籤，我們就無法就 eGFR 和長期腎臟保存數據進行商業討論。

So that's really Jula seen in the medical science result that had the conversation in the field.

這確實是朱拉在現場討論的醫學結果中看到的。

In personal conversation that I've had with physicians is they're excited about the continuation of proteinuria reduction.

在我與醫生的私人談話中，他們對蛋白尿的持續減少感到興奮。

And if you saw, if you look at the data and you look after two year proteinuria production, then you see that about two-thirds of the irbesartan, the active control arm, proteinuria effect was waning, while FILSPARI actually continued to hold quite nicely.

如果你看一下數據並觀察兩年蛋白尿的產生，你會發現大約三分之二的厄貝沙坦（活性對照組）的蛋白尿效應正在減弱，而 FILSPARI 實際上繼續保持得很好。

And that gives thought leaders confidence that there will be that long-term continued kidney preservation.

這讓思想領袖相信，腎臟將會得到長期持續的保存。

I mean, we measured this up to two years.

我的意思是，我們測量了長達兩年的時間。

So given that you impact one of the main damaging factors in proteinuria is a marker of damage.

因此，考慮到影響蛋白尿的主要損害因素之一是損害的跡象。

If you really are able to continuously reduce that, there is a translation to long-term kidney preservation.

如果你真的能夠不斷減少這一點，就可以實現長期腎臟保存。

So that's why I'm most excited about.

這就是我最興奮的原因。

Maybe Jula can talk about

也許朱拉可以談談

(inaudible)

（聽不清楚）

Thanks, Peter.

謝謝，彼得。

Well, our teams have been in hand with the PROTECT data and being able to engage both community and academic leaders, and they continue to hear a change in the momentum from when we first released the data and people didn't understand it.

嗯，我們的團隊一直在處理保護數據，並能夠讓社區和學術領袖參與進來，他們繼續聽到我們第一次發布數據時的勢頭髮生了變化，而人們並不理解它。

But we're doing things like journal clubs and engagement, where they really have a full understanding of the magnitude and durability of proteinuria reduction, the preservation of kidney function, which gets better year-over-year combined with long-term safety.

但我們正在做期刊俱樂部和參與等活動，讓他們真正充分了解蛋白尿減少的程度和持久性、腎功能的保護，這些功能逐年變得更好，並且長期安全。

And as I mentioned on the call, we are starting to hear back that this should be a foundational treatment for patients with IgA nephropathy.

正如我在電話中提到的，我們開始收到回饋，這應該成為 IgA 腎病患者的基礎治療方法。

And as we have full approval, a full label, and the commercial team also able to discuss this, I believe that we're going to have an even incremental role across the spectrum, being able to treat patients with IgA nephropathy.

由於我們獲得了充分批准、完整的標籤，而且商業團隊也能夠對此進行討論，我相信我們將在整個領域發揮更重要的作用，能夠治療 IgA 腎病患者。

So for the next part of the question.

那麼對於問題的下一部分。

Yes, Peter, why don't you take the next part of the question on what parts of the label do you think are going to drive uptake?

是的，彼得，為什麼不回答問題的下一部分，也就是你認為標籤的哪些部分會推動採用？

Yes, I was going to get there, and I think the question was really like, how fast update do you expect?

是的，我正打算到達那裡，我認為問題實際上是，您期望更新多快？

Yes, I think given -- I mean, we spoke about it at the launch call last week.

是的，我認為考慮到——我的意思是，我們在上週的發布會上談到了這一點。

In general, the nephrologists are a relatively conservative audience.

一般來說，腎病專家是相對保守的受眾。

I don't think things go quickly in general.

我不認為事情進展得很快。

But having said that, we are really excited about like the full data that we can now communicate with physicians, and we really allow for that uptake as well.

但話雖如此，我們對現在可以與醫生溝通的完整數據感到非常興奮，而且我們也確實允許這種吸收。

The strengthening of the FILSPARI label, the strengthening of the profile, all the elements that Jula was talking about, the long-term kidney preservation and safety data, and the long-term proteinuria benefit that will have an impact.

FILSPARI 標籤的強化、形象的強化、Jula 談論的所有要素、長期腎臟保存和安全數據以及將產生影響的長期蛋白尿益處。

But I wouldn't say it's a onetime step.

但我不會說這是一次性的步驟。

I think it's a continuation of growth that we anticipate moving forward.

我認為這是我們預期的持續成長。

Thank you.

謝謝。

Yigal Nochomovitz, Citi

伊格爾·諾霍莫維茨，花旗銀行

Hi, this is [Raena] on for Yigal.

大家好，我是 Yigal 的 [Raena]。

Thanks for taking my question.

感謝您提出我的問題。

Just wanted to ask, on the inclusion of the KDIGO guidelines, what are your expectations around where FILSPARI will fit?

只是想問一下，對於納入 KDIGO 指南，您對 FILSPARI 的適用範圍有何期望？

Do you see it being used as an independent frontline option only after failure or in combination?

您認為它是在失敗後才被用作獨立的前線選項還是組合使用？

Do you have any additional detail on physician-payer perspective for this?

您對此有關於醫生付款人觀點的任何其他詳細資訊嗎？

All right, Jula, why don't you take that one?

好吧，朱拉，你為什麼不拿那個？

And Peter, you can add anything on the payer perspective.

彼得，你可以從付款人的角度添加任何內容。

So given that we've published the PROTECT data and we have approval of FILSPARI, both in U.S. and Europe, FILSPARI, we know, are included in the KDIGO guidelines.

因此，鑑於我們已經發布了 PROTECT 數據，並且我們在美國和歐洲都獲得了 FILSPARI 的批准，我們知道 FILSPARI 已包含在 KDIGO 指南中。

And consistent with other guidelines and recent publications, we anticipate FILSPARI will be included as part of the foundational care for treatment of kidney injury that we know occurs and leads to diagnosis of patients with IgA nephropathy.

與其他指南和最近出版物一致，我們預計 FILSPARI 將被納入治療腎損傷的基礎護理的一部分，我們知道腎損傷會發生並導致 IgA 腎病患者的診斷。

The other aspect that Peter started to discuss is, we know that there's evidence that patients remain at risk for kidney failure with even low levels of proteinuria.

彼得開始討論的另一個方面是，我們知道有證據表明，即使蛋白尿水平較低，患者仍然面臨腎衰竭的風險。

So we anticipate the guidelines will push for earlier diagnosis and treatment to even lower levels of proteinuria.

因此，我們預計該指南將推動早期診斷和治療，以降低蛋白尿水平。

So these two components, FILSPARI and the guidelines as foundation for treating the kidney injury, as well as diagnose and treat the lower levels of proteinuria, we believe the KDIGO guidelines can really help expand the population of patients who would be treated with FILSPARI as a foundational treatment.

因此，FILSPARI 和指南這兩個部分作為治療腎損傷以及診斷和治療較低水平蛋白尿的基礎，我們相信 KDIGO 指南確實可以幫助擴大接受 FILSPARI 作為治療藥物的患者群體。

Building on that, I think to Jula's point, it's really about two categories, one, like really the natural protective medicine that acts within the kidney.

在此基礎上，我認為就朱拉的觀點而言，它實際上涉及兩類，一類是真正在腎臟內起作用的天然保護藥物。

And then the second category is more the immune mediation.

第二類更多的是免疫介導。

And to the point that you make like why we see FILSPARI, I think that will be reflected in the KDIGO guidelines as well, is really replacing large inhibition, in particular age inhibitors and AMDs.

至於您所說的為什麼我們會看到 FILSPARI，我認為這也將反映在 KDIGO 指南中，它確實正在取代大量的抑製作用，特別是年齡抑制劑和 AMD。

And that's the case already today.

今天的情況就是這樣。

And that's also how FILSPARI is being affected in the payer plans.

這也是 FILSPARI 在付款人計畫中受到影響的方式。

I think it was the second part of your question.

我認為這是你問題的第二部分。

Yes, that's right.

是的，沒錯。

I mean, I think if we take a step back and we think about how the KDIGO guidelines are going to help in driving what we're already seeing within the treatment paradigm.

我的意思是，我認為如果我們退一步思考 KDIGO 指南將如何幫助推動我們在治療範式中已經看到的情況。

One, we now have the opportunity to reach for complete remission, and we know that most patients on ACE or ARB and steroids don't achieve or sustain complete remission.

第一，我們現在有機會達到完全緩解，而且我們知道大多數接受 ACE 或 ARB 和類固醇治療的患者無法實現或維持完全緩解。

And so there is going to be the ability to reach that, but it's going to require for most patients, combination therapy.

因此，我們將有能力實現這一目標，但對於大多數患者來說，這將需要聯合治療。

So while we don't yet have the KDIGO draft guidelines, I think we fully expect that the underlying trend that we're seeing within this space is increased combination.

因此，雖然我們還沒有 KDIGO 指南草案，但我認為我們完全預期我們在這個領域看到的基本趨勢是增加組合。

And as we're already seeing, FILSPARI is going to be a core part of that, because we have the superior profile for that action in the kidney and the proteinuria reduction.

正如我們已經看到的，FILSPARI 將成為其中的核心部分，因為我們在腎臟作用和減少蛋白尿方面擁有卓越的表現。

So I think fundamentally the KDIGO guidelines and whatever they shape are going to help in driving more aggressive therapy, because remission is now within reach for many of these patients.

因此，我認為從根本上說，KDIGO 指南及其製定的任何內容都將有助於推動更積極的治療，因為對於許多此類患者來說，緩解現在是可以實現的。

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑弗里斯。

Hi, congrats on the quarter and thanks for taking my question.

您好，恭喜本季度，感謝您提出我的問題。

I'll shift gears and ask about FSGS.

我會換個話題，詢問 FSGS 的狀況。

For the PARASOL Group's work to establish alternative FSGS endpoints, do you have a sense of what the outcomes could entail?

對於 PARASOL Group 建立替代 FSGS 終點的工作，您是否了解其結果可能會帶來什麼？

And can DUPLEX potentially satisfy those endpoints in post-hoc analyses or in a subgroup of FSGS patients?

DUPLEX 能否在事後分析或 FSGS 患者亞群中滿足這些終點？

Or do you expect you would have to run a new supplemental study?

或者您預計必須進行一項新的補充研究？

All right, Maury, thanks for the questions.

好的，莫里，謝謝你的提問。

Jula, why don't you take these?

朱拉，你為什麼不拿走這些？

Yes.

是的。

So PARASOL is continuing their efforts, and while I can't speak for PARASOL, we do know from the DUPLEX study, as I earlier mentioned on the call, eGFR is not an appropriate endpoint for FSGS.

因此，PARASOL 正在繼續努力，雖然我不能代表 PARASOL，但我們確實從 DUPLEX 研究中知道，正如我之前在電話中提到的，eGFR 不是 FSGS 的合適終點。

There's too much variability.

變化太大了。

So the next reasonable endpoint to look at is proteinuria, how you measure that other different aspects.

因此，下一個要考慮的合理終點是蛋白尿，以及如何測量其他不同方面。

And importantly, within DUPLEX, we saw a meaningful effect that was statistically significant on the modified partial remission endpoint.

重要的是，在 DUPLEX 中，我們看到了一個有意義的效果，這種效果在修改後的部分緩解終點上具有統計顯著性。

Now, PARASOL was created to establish new endpoints.

現在，PARASOL 的誕生是為了建立新的端點。

And what we've heard from public commentary and what they've analyzed so far is that similar to what we saw with DUPLEX, eGFR is not suitable.

我們從公眾評論中聽到的以及他們迄今為止的分析表明，與我們在 DUPLEX 中看到的類似，eGFR 並不合適。

So then what they're moving to next is what is the right endpoint.

那麼他們下一步要做的就是什麼是正確的端點。

And they are looking at measures of proteinuria and other aspects, and they're making very good progress on these alternative endpoints with a plan to read out at ASN, and they're on track for that.

他們正在研究蛋白尿和其他方面的測量，他們在這些替代終點方面取得了非常好的進展，並計劃在 ASN 上公佈，他們正在朝著這個目標邁進。

What that translates to us is a very exciting place to be for FSGS patients and a potential path forward for FILSPARI and FSGS, based on the work that they've done to date.

這對我們來說意味著對於 FSGS 患者來說是一個非常令人興奮的地方，並且基於 FILSPARI 和 FSGS 迄今為止所做的工作，這也是他們潛在的前進道路。

More to come, and we'll give you more of an update later this year.

未來還會有更多內容，我們將在今年稍後為您提供更多更新。

Got it.

知道了。

Okay.

好的。

Thank you.

謝謝。

Laura Chico, Wedbush Securities.

勞拉·奇科，韋德布希證券。

Hi, thank you very much for taking the question.

您好，非常感謝您提出問題。

This is [Dylan] on for Laura Chico.

這是勞拉·奇科 (Laura Chico) 的[迪倫]。

So when you consider the setup for the second half of 2024, what is more impactful to FILSPARI uptake?

那麼，當您考慮 2024 年下半年的安排時，什麼對 FILSPARI 的採用影響更大？

Would it be the potential KDIGO guideline revisions?

這會是 KDIGO 指南的潛在修訂嗎？

Or would it be a potentially updated FILSPARI prescribing label?

或者它會是一個可能更新的 FILSPARI 處方標籤嗎？

Yes, Dylan, thanks for the question.

是的，迪倫，謝謝你的提問。

I would say that we are in such a great position because the timing for us could not be better.

我想說，我們處於如此有利的位置，因為我們的時機再好不過了。

It's really the synergy of both.

這確實是兩者的協同作用。

To be able to have KDIGO guidelines that could potentially lower the target, to be able to reach more patients that need better therapy at a time where we're able to expand our label and reach more patients, we're really excited about both of those occurring near simultaneously to drive further uptake of FILSPARI as a foundational therapy.

為了能夠制定可能降低目標的 KDIGO 指南，能夠在我們能夠擴大標籤並覆蓋更多患者的同時覆蓋更多需要更好治療的患者，我們對這兩者感到非常興奮這些幾乎同時發生，以推動FILSPARI 作為基礎療法的進一步應用。

So I don't know that we really parse them out as either.

所以我不知道我們是否真的將它們解析為兩者之一。

We're seeing that they're going to really influence each other in the treatment paradigm.

我們看到他們將在治療模式中真正相互影響。

Thank you.

謝謝。

Alex Thompson, Stifel.

亞歷克斯湯普森，斯蒂菲爾。

Hey, thanks for taking our question.

嘿，感謝您提出我們的問題。

I just want to follow-up again on PARASOL.

我只是想再次跟進 PARASOL。

I think you had mentioned in the past that there was an initial meeting, I believe in June.

我想你過去曾提到有一次初步會議，我相信是在六月。

Can you -- were you in attendance?

你能——你出席了嗎？

Someone from Travere in attendance.

來自特拉維雷的某人出席了會議。

And was this discussion of moving towards a proteinuria endpoint really the topic of the conversation?

關於邁向蛋白尿終點的討論真的是對話的主題嗎？

Any color on the meeting itself would be helpful.

會議本身的任何顏色都會有幫助。

Thank you.

謝謝。

All right.

好的。

Jula, why don't you take that one?

朱拉，你為什麼不拿那個？

Yes, thanks for the question.

是的，謝謝你的提問。

So PARASOL is a partnership with academics, FDA, EMA, industry was invited, and yes, we were in attendance.

所以 PARASOL 是與學術界、FDA、EMA、工業界的合作夥伴，我們也參加了。

And there is discussion, as I mentioned, around what is the appropriate endpoint.

正如我所提到的，圍繞著什麼是適當的終點進行了討論。

But that work remains ongoing with a plan to publicize that work later.

但這項工作仍在進行中，並計劃稍後公佈這項工作。

I would say that we're very encouraged by the analyses and the data that has been put forward, which gives us increased confidence around a potential path forward.

我想說的是，我們對所提出的分析和數據感到非常鼓舞，這讓我們對潛在的前進道路更有信心。

But we need to wait for the full readout, the full alignment across the different organizations and groups to say, yes, these are the appropriate endpoints to analyze.

但我們需要等待完整的讀數，不同組織和團體之間的全面協調，然後說，是的，這些是需要分析的適當終點。

And importantly, as I said earlier, we feel solid about the DUPLEX data and about a path forward for FILSPARI for the treatment of FSGS, not only because of our data, but also the unmet need.

重要的是，正如我之前所說，我們對 DUPLEX 數據以及 FILSPARI 治療 FSGS 的前進道路充滿信心，不僅因為我們的數據，還因為未滿足的需求。

Great.

偉大的。

Just to clarify, I guess, your focus today talking about proteinuria, is that based on the discussion explicitly?

我想澄清一下，您今天討論的重點是蛋白尿，這是基於明確的討論嗎？

Or is just your view of DUPLEX?

還是只是您對 DUPLEX 的看法？

Thanks.

謝謝。

So that is based on the discussion that the work has been going on, and this is public.

這是基於這項工作一直在進行的討論，而且是公開的。

If you look, the PARASOL says defining a new endpoint, either based on kidney function, GFR, and predicting preservation of kidney function, which is avoiding of dialysis long-term.

如果你仔細觀察，PARASOL 會說定義一個新的終點，要麼基於腎功能、GFR，要麼預測腎功能的保存，從而避免長期透析。

So we increasingly feel encouraged, based on the fact and the analysis that they've done around eGFR, saying, this is a difficult endpoint, let's move past eGFR and look at other measurements, of which proteinuria is the top of the list.

因此，基於事實和他們圍繞 eGFR 所做的分析，我們越來越感到鼓舞，他們說，這是一個困難的終點，讓我們超越 eGFR，看看其他測量值，其中蛋白尿是最重要的。

Great.

偉大的。

Thank you.

謝謝。

Yes, I think the only thing we had, Alex, is our perspective is also informed by the work that we've done over the number of years, both in looking at identifying an endpoint like the FSGS partial remission endpoint, as well as subsequent analyses from our Phase 2 DUET study, where patients were followed for many years, showing that those patients that were able to achieve complete remission really had a better trajectory for their disease.

是的，Alex，我認為我們唯一的觀點是我們多年來所做的工作，包括確定像 FSGS 部分緩解終點這樣的終點，以及後續的研究我們對患者進行多年隨訪的2 期DUET 研究的分析表明，那些能夠實現完全緩解的患者確實有更好的疾病軌跡。

So I think it's informed by the gestalt of all of the data that we've been doing and also what we're hearing from PARASOL at this point.

所以我認為這是由我們一直在做的所有數據以及我們目前從 PARASOL 聽到的數據得出的。

But as Jula mentioned, really, we've got to wait till they report out later this fall.

但正如朱拉所提到的，實際上，我們必須等到他們今年秋天晚些時候發布報告。

Great.

偉大的。

Thanks, Jula and Eric.

謝謝朱拉和埃里克。

(Operator Instructions) Tim Lugo, William Blair.

（操作員說明）蒂姆·盧戈，威廉·布萊爾。

Hi, team.

大家好。

This is John on for Tim.

這是約翰替提姆發言。

So I was wondering if you could give us an idea of, say, if the REMS requirements for the current FILSPARI label were not adjusted with the upcoming PDUFA, what are some of the timelines or data updates we could be looking to -- for when you'll be looking to reengage with the FDA to discuss amending the REMS again?

因此，我想知道您是否能給我們一個想法，例如，如果當前 FILSPARI 標籤的 REMS 要求未隨即將推出的 PDUFA 進行調整，我們可能會關注哪些時間表或數據更新 - 何時進行您會尋求與FDA重新接觸以討論再次修改REMS 嗎？

Sure.

當然。

Well, I think what we can say is consistent with how we've shared our perspective on REMS update and providing FDA with additional safety along the way, both from the completion of our trials such as DUPLEX, as well as the post-marketing exposure that we've had now that FILSPARI is used commercially.

嗯，我認為我們可以說的是，我們如何分享我們對 REMS 更新的看法，並一路向 FDA 提供額外的安全性，無論是從 DUPLEX 等試驗的完成，還是上市後的暴露來看。知道FILSPARI 已用於商業用途。

Of course, all of that will be shared with FDA.

當然，所有這些都將與 FDA 共享。

The first opportunity that we saw to engage the FDA on a potential modification of the REMS was in the sNDA process, and obviously, we're in the midst of that.

我們看到的第一個讓 FDA 參與對 REMS 進行潛在修改的機會是在 sNDA 流程中，顯然，我們正處於其中。

And we have a practice of not discussing updates along the way in that process, which is why we feel that the first opportunity is at full approval to share that.

我們的做法是在此過程中不討論更新，這就是為什麼我們認為第一個機會是在完全批准的情況下分享的。

But we also believe that there are multiple opportunities along the way after approval to continue to bolster the safety package and continued review of the label with FDA along the way.

但我們也相信，在獲得批准後，還有很多機會可以繼續加強安全方案，並繼續與 FDA 一起審查標籤。

So more to come very soon.

所以很快就會有更多。

Thank you.

謝謝。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

This is [Fadi] on for Mohit.

這是 Mohit 的 [Fadi]。

Thanks for taking our questions.

感謝您回答我們的問題。

So with a complement inhibitor expected to be approved soon, I wanted to get your view on how FILSPARI and the ERA class would fit into a future treatment paradigm in IgAN with complement inhibitors and also the new B cell agents coming to market?

因此，由於補體抑制劑預計很快就會獲得批准，我想了解您對 FILSPARI 和 ERA 類藥物如何適應補體抑制劑以及即將上市的新型 B 細胞藥物的 IgAN 未來治療範例的看法？

Do you think there will be a lot of combination use?

你覺得組合使用會很多嗎？

And do you think doctors right now understand the potential for combination use with these various agents?

您認為醫生現在了解這些不同藥物合併使用的潛力嗎？

And do you think costs of these drugs would be a limitation as far as combination use?

您認為這些藥物的成本是否會成為合併使用的限制？

Thanks.

謝謝。

Okay, great.

好的，太好了。

Jula, why don't you start and Peter, certainly add anything further from your perspective.

Jula，為什麼不開始，Peter，當然可以從你的角度進一步補充一些東西。

Thanks.

謝謝。

So I want to highlight the treatment algorithm has really always been two-pronged.

所以我想強調治療演算法其實一直是雙管齊下的。

You target the kidney injury with RAS inhibitors and maybe SGLT2s, and then you may also add immunosuppressants to block the immune system activation.

您可以使用 RAS 抑制劑和 SGLT2 來針對腎損傷，然後您也可以添加免疫抑制劑來阻止免疫系統活化。

So this two-pronged approach, target the kidney, target the immune system.

因此，這種雙管齊下的方法，針對腎臟，針對免疫系統。

But increasingly now and over time, we're going to have superior safer medicines for each of those buckets.

但現在以及隨著時間的推移，我們將為每個類別提供更優質、更安全的藥物。

And you're right, likely combination therapy is going to be needed in the future.

你是對的，未來可能需要聯合治療。

But I want to highlight, FILSPARI is the only medicine approved or in development that has shown superiority to be able to replace the standard of care role of RAS inhibitors on that side of targeting kidney injury.

但我想強調的是，FILSPARI 是唯一已批准或正在開發的藥物，它顯示出能夠取代 RAS 抑制劑在針對腎損傷方面的標準治療作用的優勢。

Now, when you target immune system overactivation, we're excited that there's going to be a replacement for steroids on the horizon, whether it's going to be B cell BAFF complement inhibitors, and it's clearly going to be that we're going to need multiple medications because no one drug now or in development can get all patients into complete remission, which is ultimately the goal.

現在，當你針對免疫系統過度活化時，我們很高興即將出現類固醇的替代品，無論是 B 細胞 BAFF 補體抑制劑，而且顯然我們將需要多種藥物治療，因為現在或正在開發的藥物沒有一種可以使所有患者完全緩解，這是最終的目標。

And Eric mentioned this, but we have very strong data around complete remission.

艾瑞克提到了這一點，但我們有關於完全緩解的非常強大的數據。

One-third of patients in PROTECT got there.

PROTECT 計畫中有三分之一的患者到達了那裡。

Two-thirds of patients when they were started earlier gotten to complete remission in sparsentan.

三分之二的患者在早期開始服用稀疏坦後獲得完全緩解。

But you're still going to need combination.

但你仍然需要組合。

And increasingly we're hearing that we're not going to wait over time.

我們越來越多地聽說我們不會再等待。

We're likely going to be using therapies early on after diagnosis and in combination really to optimize long-term outcomes for patients with IgA nephropathy.

我們可能會在診斷後儘早使用治療方法並結合起來真正優化 IgA 腎病患者的長期結果。

Peter, anything you want to add?

彼得，你還有什麼要補充的嗎？

Yes.

是的。

From a pricing perspective, first of all, let me reiterate that Jula said, I mean, complement space in a different category than FILSPARI from this.

從定價角度來看，首先讓我重申 Jula 所說的，我的意思是，從這個角度補充與 FILSPARI 不同類別的空間。

FILSPARI is really nephroprotective within the kidney, replacing large inhibition and taking mind.

FILSPARI 對腎臟具有真正的腎臟保護作用，可取代大量的抑製作用和注意事項。

All new modalities are always being studied on top of RAS inhibition.

所有新療法始終在 RAS 抑制的基礎上進行研究。

With regards from a payer perspective and how they will think about innovative combination therapies?

從付款人的角度來看，他們將如何考慮創新的聯合療法？

You have to take into consideration that FILSPARI is priced for broad use and broad utilization, really allowing to position it as a foundational care.

您必須考慮到 FILSPARI 的定價適合廣泛使用和廣泛使用，確實可以將其定位為基礎護理。

It's priced at a very different level than the complement inhibitor that you were referring to that already has an indication in BMS.

它的價格水平與您提到的補體抑制劑有很大不同，補體抑制劑已在 BMS 中顯示。

Additionally, I also want to say like we have a very strong update at the payer side and we are now already included in over 1,250 formularies across the nation.

此外，我還想說，我們在支付方方面進行了非常強大的更新，我們現在已經被納入全國 1,250 多個處方集。

So a very strong positioning in formula for FILSPARI.

因此，FILSPARI 的配方定位非常強大。

So I feel quite good about it.

所以我對此感覺很好。

But again, it's based in a different category and FILSPARI strives for broad utilization.

但同樣，它基於不同的類別，FILSPARI 力求廣泛使用。

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Great.

偉大的。

Thanks for taking my question.

感謝您提出我的問題。

So just one going back to the patient start forms for FILSPARI.

因此，只需填寫一份 FILSPARI 患者起始表格即可。

So it looks like you've had steady increases in the number of patients start forms, but the increase in actual sales is much more significant this quarter or even over the last few quarters relative to the percentage increase on the PSF side.

因此，看起來患者開始表格的數量穩步增加，但相對於 PSF 方面的百分比增長，本季甚至過去幾個季度的實際銷售額增長要顯著得多。

So just curious, what's driving that?

所以只是好奇，是什麼推動了這一點？

Is that better conversion of people getting PSFs getting started on therapy?

獲得 PSF 的人開始接受治療是否會更好？

Is it maybe something more on the net pricing side that's driving that, where you're getting more net sales per script?

是否有更多的淨定價方面的因素推動了這一趨勢，即每個腳本獲得了更多的淨銷售？

Or maybe it's just a timing thing where there were PSFs written earlier that just took some time to get bills?

或者也許這只是一個時間問題，之前寫的 PSF 只是花了一些時間才收到帳單？

So maybe just a little bit of more visibility there would be helpful to get a sense of what to expect going forward.

因此，也許稍微多一點的可見度就會有助於了解未來的預期。

All right.

好的。

Peter, why don't you take that one?

彼得，你為什麼不拿那個？

Yes.

是的。

First of all, I mean, it was a continuation of growth in both sectors, both patients start forms that speaks to continued demand, but in particular also on the progress that we have made on revenue.

首先，我的意思是，這兩個領域都在持續成長，兩位患者都開始填寫表格，這顯示了持續的需求，但特別是我們在收入方面取得的進展。

And I think the revenue growth, where you're going at, like, why do you see a much stronger growth percentage on revenue relative to demand?

我認為收入成長，你的意思是，為什麼你認為收入相對於需求的成長百分比要高得多？

I think it's really like a reflection of the continuation of efficiencies we have in our fulfillment process.

我認為這確實反映了我們在履行流程中持續提高效率。

And I think an earlier question today was about the pocket of patients that we saw last year that are part of the cumulative amount of patient starts that caused a little slower uptake in the transition to paid shipments.

我認為今天早些時候的一個問題是關於我們去年看到的部分患者，這些患者是患者開始累積數量的一部分，導致向付費運送的過渡稍慢。

We have made our modifications there, and we see now much faster REMS certifications early on that allows them to pull patients through and get them to paid shipments early on.

我們已經在那裡進行了修改，我們現在看到早期的 REMS 認證速度要快得多，這使他們能夠幫助患者渡過難關，並讓他們儘早付款。

And I think that's really the reflection, the efficiencies in the portfolio, that's the reflection that you see in that revenue growth.

我認為這確實是投資組合效率的反映，這就是您在收入成長中看到的反映。

Yes, I think -- Peter, thanks.

是的，我想──彼得，謝謝。

The only thing that I would add, Vamil, is that, we have a very high rate of compliance and persistence with this medication.

Vamil，我唯一要補充的是，我們對這種藥物的依從性和堅持率非常高。

These patients get good support for the chronic use of FILSPARI.

這些患者對長期使用 FILSPARI 得到了良好的支持。

But I think the one thing that's impressed me so much with this launch are the personal stories that we hear on a weekly basis about patients that finally, for the first time since their diagnosis, oftentimes for decades, they finally on FILSPARI feel like they're winning and that their proteinuria is under control.

但我認為這次發布給我留下深刻印象的一件事是我們每週都會聽到有關患者的個人故事，這些故事是自診斷以來（通常是幾十年來）第一次，他們終於在FILSPARI上感覺自己「重新獲勝並且他們的蛋白尿得到控制。

That drives so much of the high compliance rate that we see.

這在很大程度上推動了我們看到的高合規率。

And that's what one of the things that gets me really excited about the long-term outlook for FILSPARI.

這就是讓我對 FILSPARI 的長期前景感到非常興奮的事情之一。

Okay.

好的。

Thank you.

謝謝。

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Hi, good afternoon, everyone.

嗨，大家下午好。

This is Thomas Yip asking a couple of questions for Ed. Thank you so much for taking our question.

我是 Thomas Yip，向 Ed 問了幾個問題。非常感謝您提出我們的問題。

So one from us.

所以我們就來一份吧。

Can you discuss the average persistent rates of patients on FILSPARI?

您能討論一下 FILSPARI 患者的平均持續率嗎？

And what is the average time to convert PSFs to drug fulfillment for FILSPARI?

將 PSF 轉換為 FILSPARI 藥物履行的平均時間是多少？

Thank you so much.

太感謝了。

All right.

好的。

Thanks, Thomas.

謝謝，托馬斯。

So Peter, why don't you take those questions?

那麼彼得，你為什麼不回答這些問題呢？

Yes, I was referring to the high persistency and compliance rates, which are at the high end, what you would expect for chronic therapy like FILSPARI, we haven't disclosed the specific numbers.

是的，我指的是高持久性和依從性，這是您對 FILSPARI 這樣的慢性療法所期望的高端水平，我們尚未透露具體數字。

With regards to the time to get to paid shipments, I think at the launch call last year I mentioned that in my experience, in average, you see in rare disease fulfillment time between 20 and 60 days.

關於付款發貨的時間，我想在去年的發布會上我提到過，根據我的經驗，罕見疾病的平均履行時間在 20 到 60 天之間。

I think we are well within the benchmark.

我認為我們完全在基準範圍內。

We were initially at the higher end, and now we are at the more efficient part of the fulfillment.

我們最初處於較高的一端，現在我們處於履行過程中更有效的部分。

So I think we are making really good progress in the time to fill.

所以我認為我們在填補時間方面取得了非常好的進展。

And to my earlier answer, I think that's also reflected in the revenue growth this quarter.

對於我先前的回答，我認為這也反映在本季的營收成長中。

Thank you.

謝謝。

Ladies and gentlemen, this concludes the question-and-answer session of today's conference call.

女士們、先生們，今天電話會議的問答環節到此結束。

I'll hand the call back over to Nivi.

我會把電話轉回給 Nivi。

Great.

偉大的。

Thank you, everyone, for joining us for our second quarter 2024 financial results call.

感謝大家參加我們的 2024 年第二季財務業績電話會議。

We look forward to providing additional updates on our progress.

我們期待提供有關我們進展的更多最新資訊。

Have a great rest of your day.

祝您有個愉快的一天。

This does conclude today's call.

今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。