Akebia Therapeutics Inc (AKBA) 2026 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to Akebia's first quarter 2026 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco. Please go ahead.

各位早安，感謝您稍候。歡迎參加 Akebia 2026 年第一季財務業績電話會議。（接線員指示）請注意，今天的會議將被錄音。現在我想把會議交給今天的第一位講者 Mercedes Carrasco。請開始。

Thank you, and welcome to Akebia's first quarter 2026 financial results and business update conference call. Please note that a press release was issued earlier today, Thursday, May 7, detailing our first quarter 2026 financial results, and that release is available on the Investors section of our website. For your convenience, a replay of today's call will be available on our website after we conclude.

謝謝您，歡迎參加 Akebia 2026 年第一季財務業績與業務更新電話會議。請注意，我們已於今日（5 月 7 日，星期四）稍早發布新聞稿，詳述 2026 年第一季財務業績；該新聞稿可於我們網站的投資人（Investors）專區查閱。為方便各位，待本次會議結束後，今日電話會議的重播也將於我們網站提供。

Joining me for today's call, we have John Butler, Chief Executive Officer; Nick Grund, Chief Commercial Officer; and Erik Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer, will also be available during Q&A.

與我一同參與今天電話會議的有：執行長 John Butler；商務長 Nick Grund；以及財務長兼商務長 Erik Ostrowski。我們的醫務長 Steven Burke 醫師也將在問答環節（Q&A）期間待命。

I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on May 7 as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

我想提醒各位，本次電話會議包含前瞻性陳述。本次電話會議中的每一項前瞻性陳述均受風險與不確定性影響，可能導致實際結果與這些陳述所描述者存在重大差異。更多關於這些風險的資訊，載於我們於 5 月 7 日發布的財務業績新聞稿，以及我們最近向美國證券交易委員會（SEC）提交的年度與季度報告中的「風險因素」與「管理層討論與分析」章節。接下來，我想介紹我們的執行長 John Butler。

Thanks, Mercedes, and thanks to all of you for joining us this morning. We are very pleased and excited by the start to 2026. I want to focus on three key areas that we feel we need to execute on to create near- and long-term value for patients and shareholders. First, we have to drive the near-term launch performance of Vafseo; second, continue to build the clinical evidence to make Vafseo standard of care for patients on dialysis; and third, execute on our impressive kidney disease-focused clinical development pipeline.

謝謝你，Mercedes，也感謝各位今天早上加入我們。我們對 2026 年的開局感到非常滿意且振奮。我想聚焦三個我們認為必須落實執行、以為病患與股東創造短期與長期價值的關鍵領域。第一，推動 Vafseo 的短期上市表現；第二，持續建立臨床證據，使 Vafseo 成為透析病患的標準治療；第三，推進我們令人印象深刻、以腎臟疾病為核心的臨床開發產品線。

We've made important progress across each of these areas. Starting with the Vafseo launch, revenues were nearly $16 million in Q1, representing our highest quarter of Vafseo net product revenue to date and demonstrating the growth we expected over Q4 2025.

我們在上述各領域都取得了重要進展。先從 Vafseo 上市進展談起，第一季營收接近 1,600 萬美元，創下迄今 Vafseo 淨產品營收最高的單季表現，並展現出我們相較於 2025 年第四季所預期的成長。

We're pleased with the progress we're seeing within and across dialysis organizations as we expand the breadth and depth of prescribing and continue to educate the nephrology community on the benefits of Vafseo. We believe this growth is being driven by dialysis organizations that have chosen to implement an observed dosing protocol. Nick is going to expand on that important point and provide more detail on the quarter and trends we're seeing in 2026.

我們對於在各透析機構內部及跨機構所看到的進展感到滿意；隨著我們擴大處方的廣度與深度，並持續向腎臟科社群宣導 Vafseo 的效益。我們相信，這項成長主要由選擇導入「觀察給藥（observed dosing）」流程的透析機構所帶動。Nick 將就這個重要重點進一步說明，並提供本季表現與我們在 2026 年觀察到的趨勢細節。

Now we continue to work to take advantage of the TDAPA opportunity for the balance of '26. Of course, we're already planning for the beginning of 2027 when Vafseo will enter the dialysis bundle. The ESA market today for patients on dialysis is estimated to be approximately $1 billion. This is the market we're competing in, where we continue to work to become standard of care. This leads to the second area of focus - building clinical evidence.

接下來，我們也持續努力把握 2026 年剩餘期間的 TDAPA 機會。當然，我們也已在規劃 2027 年初，屆時 Vafseo 將納入透析支付組合（dialysis bundle）。目前透析病患的 ESA 市場規模估計約為 10 億美元。這就是我們競爭的市場，我們也將持續努力成為標準治療。這也引出第二個重點領域——建立臨床證據。

And that body of evidence supporting the potential benefits of Vafseo continues to grow. The post-hoc hierarchical composite endpoint analysis from our Phase III INNOVATE program in dialysis was recently published in the Journal of the American Society of Nephrology.

而支持 Vafseo 潛在效益的證據體系仍在持續累積。我們在透析領域的第三期 INNOVATE 計畫所做的事後（post-hoc）階層式複合終點分析，近期已發表於《美國腎臟學會期刊》（Journal of the American Society of Nephrology）。

The analysis demonstrated that patients treated with Vafseo in the INNOVATE trial experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator. Earlier in Q1, at the Annual Dialysis Conference, we presented an economic analysis on the cost of hospitalizations for patients treated with Vadadustat versus darbepoetin. That analysis showed that patients in the INNOVATE trial treated with Vadadustat had 7.7% fewer hospitalization events annually, a 16% reduction in hospitalization days and based on Medicare cost data, a 14.8% lower annual hospitalization cost.

該分析顯示，在 INNOVATE 試驗中接受 Vafseo 治療的病患，相較於接受 ESA 對照治療的病患，死亡或住院的風險較低。在第一季稍早的年度透析大會（Annual Dialysis Conference）上，我們也發表了 Vadadustat 相較於 darbepoetin 之住院成本的經濟分析。該分析顯示，在 INNOVATE 試驗中接受 Vadadustat 治療的病患，每年住院事件數減少 7.7%，住院天數減少 16%；並且根據 Medicare 成本資料，每年住院成本降低 14.8%。

We believe these data further supports the potential benefits of managing anemia with Vafseo and provide critical data to providers and prescribers making care decisions. We continue to share these important data with the medical and scientific community as we gear up for results from the VOCAL study expected by year-end. VOCAL is being conducted at DaVita clinics to evaluate Vafseo dosed 3 times weekly, and it contains a substudy of red blood cell characteristics, which we believe will further differentiate Vafseo's clinical profile versus ESAs. VOCAL top line data will be followed by results from the VOICE trial being run by US Renal Care, evaluating Vafseo versus standard of care on a hierarchical composite endpoint of all-cause mortality and hospitalization rates.

我們相信，這些數據進一步支持以 Vafseo 管理貧血的潛在效益，並為做出照護決策的醫療提供者與處方醫師提供關鍵資訊。隨著我們為預計於年底公布的 VOCAL 研究結果做準備，我們也持續與醫學與科學界分享這些重要數據。VOCAL 研究在 DaVita 診所進行，用以評估每週給藥 3 次的 Vafseo，並包含一項紅血球特性（red blood cell characteristics）的子研究；我們相信這將進一步凸顯 Vafseo 相較於 ESA 的臨床特徵差異。VOCAL 的主要（top line）數據之後，將接續由 US Renal Care 執行的 VOICE 試驗結果；該試驗以全因死亡率與住院率的階層式複合終點，評估 Vafseo 相較於標準治療的表現。

Top line data from VOICE are expected in early 2027; if positive, it further support the findings of the recently published Win statistics analysis.

VOICE 的主要數據預計於 2027 年初公布；若結果為正面，將進一步支持近期已發表的 Win statistics 分析之發現。

Both VOICE and VOCAL utilize a 3x weekly dosing regimen. Alliance organizations are systematically electing to move to an observed dosing protocol. We believe that shift is improving adherence and could lead to greater utilization over time. Now shifting from Vafseo to our third area of focus. Our R&D organization has been highly productive in advancing our kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward.

VOICE 與 VOCAL 皆採用每週 3 次的給藥方案。聯盟型機構正系統性地選擇轉向觀察給藥流程。我們相信，這項轉變正在改善用藥依從性，並可能隨時間推進帶來更高的使用量。接著從 Vafseo 轉到第三個重點領域。我們的研發（R&D）團隊在推進腎臟疾病產品線方面表現高度卓越；我們相信，這將成為公司未來另一項重要的價值驅動因素。

Strategically, this initiative is a natural extension for us as it leverages our expertise in kidney disease drug development, broadens our presence within the kidney community and aligns to our purpose to better the lives of people impacted by kidney disease.

在策略上，這項計畫對我們而言是自然的延伸，因為它運用我們在腎臟疾病藥物開發方面的專業，擴大我們在腎臟社群中的布局，並與我們「改善受腎臟疾病影響者生活」的使命一致。

In April, we hosted an R&D Day to review our pipeline with the investor community, and we were joined by leading medical experts, Dr. Jim Tumlin, Michael Holers and Jonathan Barratt. During that event, we reviewed the preclinical data in focal segmental glomerulosclerosis or FSGS models and prior clinical data in diabetic kidney disease for praliciguat, our soluble guanylate cyclase stimulator.

4 月，我們舉辦了研發日（R&D Day），向投資人社群回顧我們的產品線，並邀請到多位頂尖醫學專家：Jim Tumlin 醫師、Michael Holers 與 Jonathan Barratt。在該活動中，我們回顧了 praliciguat（我們的可溶性鳥苷酸環化酶刺激劑，soluble guanylate cyclase stimulator）在局灶節段性腎小球硬化症（focal segmental glomerulosclerosis，FSGS）模型中的臨床前數據，以及其在糖尿病腎病（diabetic kidney disease）中的既往臨床數據。

This is an indication that has received increased attention as there's now an approved treatment specifically for FSGS. We view this as a positive development for patients and the field. And we believe praliciguat could deliver a differentiated approach via a unique mechanism of action in this heterogeneous disease. Enrollment in our Phase II study is ongoing. We're targeting up to approximately 60 patients who are already on maximally tolerated background dose of ACEs or ARBs.

這是一個近來受到更多關注的適應症，因為目前已出現針對 FSGS 的核准治療。我們認為這對病患與整個領域而言都是正向發展。同時，我們相信 praliciguat 可透過其獨特的作用機轉，在這個異質性疾病中提供具差異化的治療方式。我們的第二期研究仍在持續收案中。我們的目標是最多約 60 名病患，且這些病患已在可耐受的最大背景劑量 ACE 抑制劑（ACEi）或 ARB（血管張力素受體阻斷劑）治療之上。

The study will evaluate change from baseline in UPCR at 24 weeks as the primary endpoint.

本研究將以第 24 週時 UPCR 相較於基線的變化作為主要終點。

AKB-097, whose generic name is Abribafisp or abri, is our tissue-targeted anti-C3D complement inhibitor. We believe this product candidate could have comparable efficacy to the most efficacious currently approved complement inhibitors in a well-characterized pathway.

AKB-097（其學名為 Abribafisp，或簡稱 abri）是我們的組織標靶型抗 C3D 補體抑制劑。我們相信，這項候選產品在一條已充分表徵的途徑中，可能具備與目前已核准且療效最強的補體抑制劑相當的療效。

Initial data suggests that abri quickly leaves the bloodstream, directly targeting the tissue of complement activation, in this case, the kidney. We believe this could avoid the increased infection risk you see with current products.

初步數據顯示，abri 會迅速離開血液循環，直接鎖定補體活化的組織，在此情況下為腎臟。我們相信這可避免目前產品所見的感染風險增加。

We also believe this will allow abri to be delivered at a lower dose in a more convenient dosing regimen. As Dr. Barratt articulated during our R&D Day presentation, abri is a second-generation complement inhibitor. We believe these characteristics support the potential for abri to be a uniquely differentiated product in the market.

我們也相信，這將使 abri 能以較低劑量、在更便利的給藥方案下投與。如 Barratt 醫師在我們研發日（R&D Day）簡報中所闡述，abri 是第二代補體抑制劑。我們相信這些特性支持 abri 有潛力成為市場上具獨特差異化的產品。

We expect to initiate a Phase II open-label basket trial in the second half of this year, evaluating abri in IgA nephropathy, lupus nephritis and C3 glomerulopathy. These indications represent a substantial market opportunity. And of course, we're evaluating additional indications to investigate as well. As part of the basket study, we'll be evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and effects on disease-relevant biomarkers such as proteinuria and kidney function.

我們預期將於今年下半年啟動一項第二期（Phase II）開放標籤的籃式試驗（basket trial），評估 abri 用於 IgA 腎病變、狼瘡性腎炎與 C3 腎小球病變。這些適應症代表可觀的市場機會。當然，我們也在評估其他可進一步研究的適應症。作為籃式研究的一部分，我們將評估安全性、耐受性、藥物動力學、藥效動力學，以及對疾病相關生物標誌物（如蛋白尿與腎功能）的影響。

Importantly, we expect the study to be designed to be able to demonstrate the efficacy and tissue targeting profile of abri. As a reminder, as the basket study is open label, we expect to begin reporting initial data in 2027.

重要的是，我們預期該研究的設計將能夠證明 abri 的療效與組織靶向特徵。提醒一下，由於籃式研究為開放標籤，我們預期將於 2027 年開始公布初步數據。

Lastly, this quarter, we were pleased to announce the initiation of a Phase I study of AKB-9090, our internally developed HIF-PH inhibitor product candidate with an expected initial indication for the prevention of acute kidney injury associated with cardiac surgery. This randomized double-blind, placebo-controlled SAD/MAD study is designed to evaluate safety, tolerability and pharmacodynamics in up to 70 healthy adult participants. And top line data from this program are expected in early 2027.

最後，本季我們很高興宣布啟動 AKB-9090 的第一期（Phase I）研究；AKB-9090 是我們內部開發的 HIF-PH 抑制劑產品候選藥物，預期初始適應症為預防與心臟手術相關的急性腎損傷。這項隨機、雙盲、安慰劑對照的 SAD/MAD 研究，旨在於最多 70 名健康成人受試者中評估安全性、耐受性與藥效動力學。該計畫的主要（top line）數據預期於 2027 年初取得。

Overall, we've had a strong start to the year, and we're making meaningful progress on both the commercial execution of Vafseo and the advancement of a pipeline that we believe can support long-term growth. Now let me turn it over to Nick for more granularity on the Vafseo launch.

整體而言，我們今年開局強勁，並在 Vafseo 的商業執行以及我們相信可支持長期成長的產品線（pipeline）推進方面取得實質進展。接下來我把時間交給 Nick，請他更細緻地說明 Vafseo 的上市進展。

Thanks, John. Good morning, folks. Like John, I am encouraged by the growth potential for Vafseo in 2026, which we believe is supported by our first quarter trends. While we ended 2025 with approximately 290,000 patients with prescribing access, the start of 2026 was when prescribing access translated to more widespread prescribing and more patients on therapy. I'll recap the quarterly results first and then explain what I believe is driving growth.

謝謝你，John。各位早安。和 John 一樣，我對 Vafseo 在 2026 年的成長潛力感到鼓舞，我們相信第一季的趨勢支持這一點。雖然我們在 2025 年底時約有 290,000 名病患具備處方可及性，但 2026 年初才是處方可及性轉化為更廣泛開立處方、以及更多病患接受治療的時點。我會先回顧季度結果，接著說明我認為推動成長的因素。

With the move to observed dosing protocols across multiple additional dialysis providers, we are no longer receiving as much detailed data as we have in the past, but I believe we can still provide a very good sense of Vafseo utilization and growth.

隨著多家新增透析服務提供者轉向「觀察給藥」（observed dosing）流程，我們不再像過去那樣收到同等程度的詳細數據，但我相信我們仍能對 Vafseo 的使用情況與成長提供非常清楚的概況。

Q1 brought a significant increase in the number of prescribers writing and patients on Vafseo. Approximately 1,025 prescribers wrote a prescription for Vafseo, which was approximately 28% higher than the number of prescribers in Q4 2025. Importantly, approximately 30% of those prescribers were from dialysis organizations other than USRC.

第一季（Q1）帶來開立處方的醫師數與使用 Vafseo 的病患數顯著增加。約有 1,025 位處方醫師為 Vafseo 開立處方，較 2025 年第四季（Q4）處方醫師數約高出 28%。重要的是，其中約 30% 的處方醫師來自 USRC 以外的透析機構。

Dialysis organizations inventory remained relatively flat from Q4 2025 to Q1 2026. As you know, we reported Vafseo inventory destocking in the fourth quarter of 2025 as a result of dialysis organizations transitioning to observed dosing protocols and the related shift in distribution from shipping bottles to patients' homes to stocking bottles at dialysis centers.

透析機構的庫存自 2025 年第四季至 2026 年第一季大致持平。如各位所知，我們曾在 2025 年第四季報告 Vafseo 的通路去庫存（inventory destocking），原因是透析機構轉向觀察給藥流程，以及相關的配送模式改變：從將藥瓶寄送至病患家中，轉為在透析中心備貨。

From a patient perspective, we note a 60% increase in the number of patients on Vafseo at the end of Q1 '26 over the number of patients at the end of Q4 2025 to nearly 7,500 patients. The number of new patient starts in quarter one was the highest in any quarter since the initial quarter of launch. The majority of new patients began in March, so Q1 revenue reflects at most only one month of treatment for these patients. We believe increases in number of prescribers writing and number of patients on Vafseo are important indicators that adoption is broadening as more organizations implement Vafseo treatment protocols that allow for greater access.

從病患角度來看，我們注意到 2026 年第一季末使用 Vafseo 的病患數，較 2025 年第四季末增加 60%，接近 7,500 名病患。第一季的新病患起始數為上市以來任何一季中最高。多數新病患於 3 月開始，因此第一季營收對這些病患而言，最多僅反映一個月的治療。我們相信，處方醫師數增加與使用 Vafseo 的病患數增加，是採用度正在擴大之重要指標，因為更多機構正在導入可提供更大可及性的 Vafseo 治療流程。

Finally, I want to spend some time on adherence and particularly the transition that dialysis organizations are making toward observed dosing protocol. By the end of the quarter, USRC had observed dosing protocols available in nearly all of their clinics as did IRC and DCI. In quarter one, approximately two thirds of all Vafseo patients were being treated three times weekly, which we expect to continue to grow in coming quarters due to these protocol decisions.

最後，我想花一些時間談談依從性（adherence），特別是透析機構正朝向觀察給藥流程的轉換。到本季末，USRC 幾乎所有診所都已提供觀察給藥流程，IRC 與 DCI 亦然。第一季約有三分之二的 Vafseo 病患採每週三次治療，我們預期在未來幾季會因這些流程決策而持續成長。

First refill adherence rates through the end of March were approximately 86% for patients treated under an observed dosing protocol. We believe this will reinforce the dialysis organization's decisions to provide access to Vafseo using observed dosing. Because of this expanded access, we anticipate the greatest opportunity for Vafseo revenue growth will be among dialysis organizations that have implemented observed dosing and expect nearly all in-center patients across DOs to be on an observed dosing protocol by the end of the year.

截至 3 月底，在觀察給藥流程下治療的病患，其首次續配（first refill）依從率約為 86%。我們相信這將強化透析機構以觀察給藥方式提供 Vafseo 可及性的決策。由於可及性擴大，我們預期 Vafseo 營收成長的最大機會將來自已導入觀察給藥的透析機構，並預期到年底，幾乎所有透析機構（DOs）的院內（in-center）病患都將採用觀察給藥流程。

We are clearly seeing more patients start at DaVita, though more slowly than at other dialysis organizations that have ramped up, and that remains our largest potential growth opportunity from a single dialysis organization. We believe DaVita will implement an observed dosing protocol in the second half of the year.

我們明顯看到在 DaVita 開始治療的病患增加，但增速較其他已加速推進的透析機構更慢；而這仍是我們來自單一透析機構的最大潛在成長機會。我們相信 DaVita 將於今年下半年導入觀察給藥流程。

To summarize, we are seeing encouraging signs in the underlying commercial indicators that matter most, including broader prescriber engagement, improved adherence in observing dosing patients and increased prescribing at dialysis organizations beyond USRC, which all lead to a significant increase in patients on Vafseo therapy. As prescribers continue to gain real-world experience with Vafseo and we generate and disseminate more data, we expect to further grow the breadth and depth of prescribing. Let me now turn it over to Erik.

總結來說，我們在最重要的底層商業指標上看到令人鼓舞的訊號，包括更廣泛的處方醫師參與、觀察給藥病患的依從性改善，以及 USRC 以外透析機構的處方增加；這些都帶動使用 Vafseo 治療的病患數大幅成長。隨著處方醫師持續累積 Vafseo 的真實世界使用經驗，且我們產出並傳播更多數據，我們預期將進一步擴大處方的廣度與深度。接下來我把時間交給 Erik。

Thanks, Nick. We're pleased to deliver Vafseo revenue growth this quarter as we continue our pursuit to make Vafseo standard of care for the treatment of anemia in dialysis patients with CKD. I'll now provide an overview of our Q1 '26 financial results as compared to the prior year. Total revenues, which are comprised of net product revenues and license and collaboration revenues were $53.5 million in Q1 '26 compared to $57.3 million in Q1 '25.

謝謝你，Nick。我們很高興本季實現 Vafseo 營收成長，並持續推進我們的目標：讓 Vafseo 成為治療慢性腎臟病（CKD）透析病患貧血的標準照護（standard of care）。我現在將概述我們 2026 年第一季（Q1 '26）相較於前一年的財務結果。總營收由產品淨營收以及授權與合作營收構成，2026 年第一季為 5,350 萬美元，較 2025 年第一季的 5,730 萬美元下降。

This decrease was driven by lower Auryxia revenues, which was partially offset by higher Vafseo revenues. Of these amounts, Vafseo net product revenues were $15.8 million in Q1 '26 compared to $12 million in Q1 '25, representing a 32% increase with an even larger increase in underlying demand as evidenced by the strong Q1 patient growth Nick described as well as by the fact that Q1 '25 revenues reflected initial customer inventory build. Auryxia net product revenues were $36.2 million in Q1 '26 compared to $43.8 million in Q1 '25, which was driven by lower Auryxia pricing.

此下降主要由 Auryxia 營收降低所致，部分被 Vafseo 營收增加所抵銷。在上述金額中，Vafseo 產品淨營收於 2026 年第一季為 1,580 萬美元，較 2025 年第一季的 1,200 萬美元增加 32%；而底層需求的增幅更大，從 Nick 所描述的第一季病患強勁成長，以及 2025 年第一季營收反映初期客戶庫存建立（inventory build）即可看出。Auryxia 產品淨營收於 2026 年第一季為 3,620 萬美元，較 2025 年第一季的 4,380 萬美元下降，主要由 Auryxia 定價較低所驅動。

Looking forward, we note that in addition to the authorized generic for Auryxia that has been on the market for the past year, an additional generic form of Auryxia has entered the market. This increased generic competition is consistent with our expectations and prior guidance. Accordingly, as we've previously communicated, we expect Auryxia revenues to decrease in 2026 as compared to 2025. Lastly, license collaboration and other revenues were $1.6 million in Q1 '26 compared to $1.5 million in Q1 '25.

展望未來，我們注意到，除了過去一年已在市場上的 Auryxia 授權學名藥之外，另一種 Auryxia 的學名藥也已進入市場。此一學名藥競爭加劇符合我們的預期與先前指引。因此，正如我們先前所溝通的，我們預期 2026 年 Auryxia 營收將較 2025 年下降。最後，授權合作及其他營收在 2026 年第一季為 160 萬美元，較 2025 年第一季的 150 萬美元增加。

Turning to expenses. Cost of goods sold was $12.3 million in Q1 '26 compared to $7.6 million in Q1 '25. This increase was primarily due to an increase in inventory write-downs, including as a result of excess and obsolescence and scrap, primarily related to Auryxia during Q1 '26. Of note, Vafseo-related COGS in both periods was derived from prelaunch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as R&D expenses in the period incurred prior to Vafseo's US approval.

接著談費用。2026 年第一季銷貨成本為 1,230 萬美元，較 2025 年第一季的 760 萬美元增加。此增幅主要來自存貨減記增加，包括因過量、過時及報廢所致，且主要與 2026 年第一季的 Auryxia 相關。值得注意的是，兩個期間與 Vafseo 相關的銷貨成本均源自上市前存貨，該存貨未包含完整製造成本，因為其中一部分與存貨相關的費用在 Vafseo 取得美國核准前、於發生當期已記錄為研發費用。

R&D expenses were $14.8 million in Q1 '26 compared to $9.8 million in Q1 '25. The increase in expenses was driven by increased clinical trial activities related to praliciguat, which we are evaluating in FSGS and AKB-9090, which we are evaluating for the prevention of cardiac surgery-related acute kidney injury as well as higher headcount-related costs.

研發費用在 2026 年第一季為 1,480 萬美元，較 2025 年第一季的 980 萬美元增加。費用增加主要由於與 praliciguat 相關的臨床試驗活動增加（我們正在 FSGS 中評估），以及 AKB-9090 相關的臨床試驗活動增加（我們正在評估其用於預防心臟手術相關急性腎損傷），並且人力編制相關成本也較高。

SG&A expense was $30.4 million in Q1 '26 compared to $25.7 million in Q1 '25. This increase was driven by higher headcount-related costs. Net loss was $9.1 million in Q1 '26 compared to net income of $6.1 million in Q1 '25. The change to a net loss in Q1 '26 resulted from lower Auryxia revenues along with higher expenses this quarter as compared to Q1 '25.

SG&A 費用在 2026 年第一季為 3,040 萬美元，較 2025 年第一季的 2,570 萬美元增加。此增幅主要由較高的人力編制相關成本所驅動。2026 年第一季淨損為 910 萬美元，相較之下 2025 年第一季淨利為 610 萬美元。2026 年第一季轉為淨損，係因 Auryxia 營收較低，且本季費用較 2025 年第一季更高所致。

Cash and cash equivalents as of March 31, 2026, were $162.6 million compared to $184.8 million as of December 31, 2025. The decrease in cash was driven by the net loss for the quarter, along with an increase in working capital. We expect our existing cash resources and cash from operations will be sufficient to fund our current operating plan for at least two years. With that, we welcome questions.

截至 2026 年 3 月 31 日，現金及約當現金為 1.626 億美元，較截至 2025 年 12 月 31 日的 1.848 億美元減少。現金下降主要由本季淨損以及營運資金增加所致。我們預期現有現金資源與營運產生的現金，將足以支應我們目前的營運計畫至少兩年。接下來我們歡迎提問。

(Operator Instructions)

（接線員指示）

Julian Harrison, BTIG.

Julian Harrison，BTIG。

Hi, good morning, and congrats on the progress. First, I'm wondering if you could talk more about the prominent increase of patients on Vafseo in March. Did you see follow-through of that trend into April? And was there may be a specific dialysis provider or providers accounting for most of that uptake? And then second, is Filspari's recent approval relevant at all to your enrollment efforts in FSGS?

嗨，早安，恭喜你們的進展。首先，我想請你們多談談 3 月 Vafseo 用藥病患數顯著增加的情況。這個趨勢在 4 月是否有延續？另外，是否可能有某一家或幾家特定的透析服務提供者貢獻了大部分的採用？第二，Filspari 近期獲批是否與你們在 FSGS 的收案工作有任何關聯？

Can you maybe walk us through how you're thinking about enrollment dynamics going forward for your Phase II trial?

你們能否帶我們了解一下，你們如何看待未來第二期試驗的收案動態？

Sure. Nick, do you want to take the first question?

當然。Nick，你要先回答第一個問題嗎？

Yes. Thanks, Julian, for the question. The increase in patients nearly 60% quarter-over-quarter really was across all of our DOs, the major ones. USRC continued to have increases as they've really moved to the observed dosing protocol in all of their clinics, which is really, as we've indicated in previous calls, allowed them to start adding new patients on without the complications of a lower adherence rate that we saw in the QD dosing scheme for in-center patients.

好的。謝謝你，Julian，提問。病患數季對季增加近 60%，確實是遍及我們所有主要的 DO（透析機構）。USRC 持續增加，因為他們已在所有診所真正轉向觀察給藥（observed dosing）流程；正如我們在先前電話會議中提到的，這讓他們能在不受我們在院內病患採用每日一次（QD）給藥方案時所見較低依從率所造成的複雜性影響下，開始納入更多新病患。

In addition, we've seen some restarts at USRC, which I think is an important characteristic. Patients that previously were on QD dosing fell off perhaps for compliance reasons. And now in a TIW, or observed dosing regimen that they're restarting them on therapy with Vafseo, which is really important.

此外，我們也在 USRC 看到一些重新開始用藥（restarts），我認為這是一個重要特徵。先前採用 QD 給藥的病患可能因依從性原因而停用。現在在每週三次（TIW）或觀察給藥的療程下，他們正讓這些病患重新以 Vafseo 開始治療，這非常重要。

IRC and DCI, really, once they got their dosing protocols in place, if you remember that was in Q4, what we saw was a very, very aggressive and accelerated adoption of the product within their physician base. That advocacy that we're seeing at IRC and DCI is strong. DaVita also had significant growth in the period. They're lagging a bit behind the others. They're still under a QD dosing protocol.

至於 IRC 與 DCI，一旦他們把給藥流程建立起來——如果你記得那是在第四季——我們看到的是在其醫師群體中非常、非常積極且加速的產品採用。我們在 IRC 與 DCI 看到的倡議力道很強。DaVita 在此期間也有顯著成長；他們相較其他機構稍微落後一些，仍採用 QD 給藥流程。

But we believe in the second quarter in the second half of the year, we'll see them moving to an observed dosing protocol as well. And so really great growth across a number of our DOs. We point to diversification. So the diversification away from USRC is an important measure to see how adoption is progressing at other dialysis organizations.

但我們相信在第二季、以及今年下半年，我們會看到他們也轉向觀察給藥流程。因此，我們在多家 DO 都看到非常好的成長。我們也強調多元化。因此，降低對 USRC 的依賴、走向多元化，是觀察其他透析機構採用進展的重要指標。

It's good to see we have significant room still to grow at USRC, DCI and IRC, where we have great momentum. We all know that DaVita needs to increase. And as Nick said, it's growing for sure. But I think it's that observed dosing protocol that's going to make all the difference in the world. So stay tuned.

很高興看到在 USRC、DCI 與 IRC 我們仍有很大的成長空間，且動能很強。大家都知道 DaVita 需要提升。正如 Nick 所說，確實在成長。但我認為觀察給藥流程將會帶來天壤之別。所以敬請期待。

But again, I mean, we we're really pleased with the growth that we're seeing in the USRC, DCI and IRC clinics and expect to see significant growth from them as the year progresses.

不過再說一次，我們對在 USRC、DCI 與 IRC 診所看到的成長非常滿意，並預期隨著年度推進，他們將帶來顯著成長。

And on the FSGS trial, yes, I mean, we think it's really a positive thing for patients. And from a regulatory perspective, you can see that FDA on this is on praliciguat, your second question, really is supportive of bringing new products for this patient population. We know while everyone is excited that sparsentan has been approved, we know this is not a product that's going to be all the difference in FSGS.

至於 FSGS 試驗，是的，我們認為這對病患而言確實是正面的事情。從法規角度來看，你可以看到 FDA 在這方面——針對 praliciguat，你的第二個問題——確實支持為這個病患族群帶來新產品。我們知道，雖然大家都對 sparsentan 獲批感到興奮，但我們也知道這不是一個能在 FSGS 上帶來決定性改變的產品。

So I'll let Steve comment, but I'll say Steve and I were down at an investigator meeting a few weeks ago, and I was incredibly pleased by how excited the physicians were about the opportunity for praliciguat and the unique mechanism of action there. And we're pleased with the progress we're making.

所以我讓 Steve 補充，但我先說，Steve 和我幾週前參加了一場研究者會議，我對醫師們對 praliciguat 機會以及其獨特作用機轉的興奮程度感到非常滿意。我們也對目前取得的進展感到高興。

There are multiple products in development there. So it is a competitive space. But we're very pleased that they're as excited as they are about praliciguat, and we think that enrollment will progress. I don't know, Steve, is there anything you want to add?

那裡有多個產品正在開發中，所以這是一個競爭激烈的領域。但我們很高興他們對 praliciguat 的興趣如此高，我們也認為收案將會持續推進。我不知道，Steve，你還想補充什麼嗎？

No, I'd just echo what you said, which is the bigger issue in conducting clinical trials is competing with other sponsors for patients. So I don't think the Filspari approval is going to have a significant we haven't heard that it's having a significant impact on enrollment. I don't anticipate it will just because it's slightly better than angiotensin receptor blockers or ACE inhibitors. And so the majority of patients are still not going to respond to that drug, and it's going to become basically just a background therapy like ACE and ARBs are.

沒有，我只是呼應你所說的：進行臨床試驗更大的問題在於要與其他贊助商競爭病患。所以我不認為 Filspari 的核准會對收案造成顯著影響——我們也沒有聽到它對收案有顯著影響。我不預期會有，因為它只比血管張力素受體阻斷劑（ARB）或 ACE 抑制劑稍好一些。因此，多數病患仍不會對該藥有反應，而它基本上會變成像 ACE 與 ARB 一樣的背景治療。

Very helpful. All around. Thanks again.

非常有幫助。各方面都是。再次感謝。

Thanks, Julian. And Steve is not here in the room with us because he's down at the NKF Spring Clinical Meeting. So I'm sure he's getting more feedback on our impressive pipeline as well. Sorry Lauren.

謝謝你，Julian。Steve 今天不在會議室裡，因為他在參加 NKF 春季臨床年會。所以我相信他也正在就我們令人印象深刻的產品線獲得更多回饋。抱歉，Lauren。

Roger Song, Jefferies.

Roger Song，Jefferies。

Hey, Tim, good morning. Thanks for the updates, and thanks for taking our questions. This is Nabil on for Roger. So great to hear about the step-up in patients and prescribers. And then regarding the first refill adherence at 86%, how should we think about that level as we dosing scales more broadly across DOs? And then I have a follow-up.

嗨，Tim，早安。謝謝更新，也謝謝你們回答我們的問題。我是代替 Roger 的 Nabil。很高興聽到病患數與開立處方的醫師數都有提升。關於首次續配（first refill）依從性達到 86%，當你們的觀察給藥（observed dosing）在各家 DO 更廣泛擴展時，我們應該如何看待這個水準？另外我還有一個追問。

Sure, Nick, you want to take that one?

當然。Nick，你要回答這題嗎？

Yes. In previous quarters, when we talked about first refill, the sample size was still relatively small. Now we're getting to the point where there are we've gotten to a sample size or penetration of observed dosing where we see a significant number of patients being utilizing protocols that have observed dosing regimen.

好的。前幾個季度我們談到首次續配時，樣本量仍相對較小。現在我們已經到了一個程度：在觀察到的給藥（observed dosing）樣本量或滲透率上，我們看到相當多病患正在採用具備觀察給藥療程的治療方案。

And so I feel pretty confident about 86% is going to stick around there. It may move a couple of points one direction or another direction. But there's no reason for us to believe at this point that it shouldn't apply as other DOs bring on. Now every DO has a little bit different protocol, whether it be starting at 900 milligrams daily, how often they titrate up, whether they're coming from Mircera or whether they're coming from Epogen. But we've seen this consistent number here, bouncing around between kind of 85 and 90 for the last couple of quarters.

因此我相當有信心 86% 會大致維持在這個水準。可能會上下波動幾個百分點，但目前沒有理由認為當其他 DO 加入時這個數字不適用。當然，每家 DO 的方案略有不同，例如是否從每日 900 毫克開始、多久上調一次劑量、是從 Mircera 轉換過來或是從 Epogen 轉換過來。但過去幾個季度我們看到這個數字相當一致，大約在 85% 到 90% 之間波動。

And so right now, we're really confident that that's how you should think about it moving forward.

所以目前我們非常有信心，你們未來就應該用這樣的方式來看待它。

Great. And then as we think about Vafseo throughout the remainder of 2026, should we expect the growth to be more linear from here or more back half weighted as the protocol adoption matures?

很好。那麼在看 2026 年剩餘時間的 Vafseo 表現時，我們應該預期成長會從現在起更線性，還是隨著方案採用成熟而更偏向下半年加速？

Thank you.

謝謝。

Yes. I mean I don't know that we can guide that granularly to how it's going to go. I mean we've as you see with 7,100 or 7,500 patients on the drug, there's lots of room to grow. We see great momentum, USRC. I mean I think particularly excited to see so many of the patients who were who went off of the drug last year with the adherence issues that they have being put back on.

是的。我想我們沒辦法把指引細到那種程度、去預測會怎麼走。你也看到目前大約有 7,100 或 7,500 名病患在用藥，成長空間很大。我們看到很好的動能，USRC。我想我們尤其很興奮的是，去年因依從性問題而停藥的許多病患，現在又被重新放回用藥。

And with the adherence rate staying on the drug, how quickly that will accelerate. These are all things that will influence it. But there's tremendous room to grow. I remember there's about 66,000 patients just between USRC, DCI and IRC. Not all of them have a TDAPA reimbursement, but the access is quite good.

再加上依從性維持在用藥上的比率，會以多快速度加速，這些都會影響走勢。但成長空間非常大。我記得光是 USRC、DCI 和 IRC 之間大約就有 66,000 名病患。並非所有人都有 TDAPA 給付，但可近性相當不錯。

So lots of room just to grow there. And then the question is, how quickly does DaVita move?

所以光是在那裡就有很大的成長空間。接下來的問題是，DaVita 會以多快速度推進？

And DaVita has really taken the strategy of allowing physicians to make the choice, whereas the others, it's more of a top-down push. Here are the patients that are available and you put them on, and they do that over time, as I said, systematically, but it is different. It's kind of a more traditional adoption curve, which it's harder to really kind of handicap exactly how quickly that's going to happen, but we know that pool is so much bigger that we need to tap into it.

而 DaVita 的策略確實是讓醫師自行做選擇；相較之下，其他機構更偏向自上而下的推動：這些病患符合條件，你就把他們納入用藥，並且如我所說，隨時間系統性地推進，但方式不同。這比較像傳統的採用曲線，因此更難精準評估會以多快速度發生；但我們知道那個池子大得多，我們需要切入。

So I don't think we could say, oh, it's going to be linear or there's going to be some hockey stick at the end of the year. But certainly, once DaVita goes to a TIW protocol, and we I mentioned like the JASN paper, the Wanab's paper. As I said, that was just published. Before it was published, our medical folks couldn't talk to physicians about it. Right now that it's published, they're out there talking about it.

所以我不認為我們能說它會是線性成長，或年底會出現某種「曲棍球棒」式的爆發。但可以確定的是，一旦 DaVita 採用 TIW（每週三次）方案，而且我提到像 JASN 的論文、Wanab 的論文——如我所說，那篇剛發表。發表之前，我們的醫學團隊不能跟醫師談這些；現在發表了，他們正在外面與醫師討論。

Those are the kinds of data that do change shapes of curve. So but exactly how quickly that happens, that's to be determined. But we really are pleased with the momentum that we have in the market today.

這類數據確實會改變曲線形狀。不過究竟會多快發生，還有待觀察。但我們對目前市場上的動能非常滿意。

Thank you for the color, and congrats on that data update.

謝謝你提供的補充說明，也恭喜這次數據更新。

Thanks very much.

非常感謝。

Matthew Caulfield, H.C. Wainwright & Co.

Matthew Caulfield，H.C. Wainwright & Co.。

Hi. Good morning, guys. For praliciguat development in FSGS, what do you view as the most clinically relevant change for the 24-week UPCR primary endpoint? Is there a certain delta that will be the most clinically relevant there in addition to preserving the podocyte health and just the overall reduced proteinuria?

嗨，早安，各位。關於 praliciguat 在 FSGS 的開發，對於 24 週 UPCR 主要終點，你們認為最具臨床意義的變化會是什麼？除了維持足細胞（podocyte）健康以及整體蛋白尿下降之外，是否有某個特定的差值（delta）會被視為最具臨床意義？

Thanks a lot.

非常感謝。

Sure. Steve, do you want to take that question?

當然。Steve，你要回答這個問題嗎？

Sure. I think we would like to see something that's on par with what we've seen with sparsentan. So something around a 20% improvement in the change in UPCR, so 20% over what's achievable with ACE and ARBs. I think the critical thing will be the proportion of patients who end up with a UPCR less than 0.7 grams per gram because that's the approvable endpoint now for FSGS. So that will be the really the key metric that will drive our decision to go into Phase III or not.

好的。我想我們希望看到的效果能與 sparsentan 的結果相當。也就是在 UPCR 變化上大約改善 20%，也就是相較於使用 ACE 與 ARB 所能達到的水準再多 20%。我認為關鍵會是最終 UPCR 低於每克 0.7 克的病患比例，因為這是目前 FSGS 可用於核准的終點。因此，這將是驅動我們是否進入第三期（Phase III）的關鍵指標。

Understood.

了解。

Thanks, Steve. Yes, I think that obviously, we're we think that's the bar, right, the sparsentan bar for approval. But as Steve said, I mean the PARASOL findings really is encouraging that we have this clarity from the FDA around what we need to do to get the product approved. And again, given the heterogeneity of the disease, the uniqueness of our mechanism, we really think that there's a place it's about 60,000 FSGS patients in the US The approval of sparsentan is great for patients, but there's significant room for new entrants. And again, hitting that clinical threshold will be critical for us.

謝謝，Steve。是的，我想很明顯地，我們認為那就是門檻，對吧，也就是 sparsentan 的核准門檻。但如 Steve 所說，PARASOL 的發現令人鼓舞，因為我們從 FDA 那裡得到明確指引，知道需要做什麼才能讓產品獲批。再者，考量疾病的異質性以及我們機轉的獨特性，我們確實認為仍有切入空間——美國大約有 60,000 名 FSGS 病患。sparsentan 的核准對病患是好事，但新進者仍有相當大的空間。而且，再次強調，達到那個臨床門檻對我們至關重要。

Thanks for the question, Matthew.

謝謝你的提問，Matthew。

Yeah, thanks, guys.

好的，謝謝各位。

Thank you. I'm showing no further questions at this time. I would now like to turn it back to John Butler for closing remarks.

謝謝。目前顯示沒有其他提問。我現在把時間交回 John Butler 做結語。

Thank you, Lauren, and thanks again to all of you for joining us this morning. We look forward to continuing to update you on the progress we're making in the launch of Vafseo, building the evidence to support Vafseo's long-term growth and the continued advancement of our robust kidney-focused pipeline. Have a great day, everybody.

謝謝你，Lauren，也再次感謝各位今天早上加入我們。我們期待持續向各位更新 Vafseo 上市推進的進展、建立支持 Vafseo 長期成長的證據，以及我們強健的腎臟聚焦產品線的持續推進。祝大家有美好的一天。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參與今天的會議。本次議程到此結束。您現在可以中斷連線。