Akebia Therapeutics Inc (AKBA) 2025 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to the Akebia's second-quarter 2025 financial results. (Operator Instructions)

您好，感謝您的支持。歡迎閱讀 Akebia 2025 年第二季財務表現。（操作員指示）

Please be advised that today's call is being recorded. I would now like to hand the conference over to your speaker, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

請注意，今天的通話正在錄音。現在，我想將會議交給發言人、投資者關係高級總監 Mercedes Carrasco。請繼續。

Thank you and welcome to Akebia's second-quarter 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, August 7, detailing our second quarter of 2025 financial results, and that release is available on the Investor Sections of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer; Nick Grund, Chief Commercial Officer; and Eric Ostrowski, Chief financial and Chief Business Officer.

感謝您並歡迎參加 Akebia 2025 年第二季財務業績和業務更新電話會議。請注意，今天早些時候（8 月 7 日星期四）發布了一份新聞稿，詳細介紹了我們 2025 年第二季度的財務業績，該新聞稿可在我們網站的投資者部分查閱。為了您的方便，我們結束後還將在我們的網站上提供今天電話會議的重播。參加今天電話會議的還有執行長約翰·巴特勒 (John Butler)、首席商務官尼克·格倫德 (Nick Grund) 和首席財務官兼首席商務官埃里克·奧斯特羅夫斯基 (Eric Ostrowski)。

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 August 7, as well as in the risk factors and management discussion and analysis section of our most recent annually -- annual and quarterly report filed with the SEC.

我想提醒大家，本次電話會議包含前瞻性陳述。本次電話會議中的每個前瞻性陳述都受到風險和不確定性的影響，這些風險和不確定性可能導致實際結果與這些陳述中描述的結果有重大差異。描述這些風險的其他資訊包含在我們於 8 月 7 日發布的財務業績新聞稿中，以及我們向美國證券交易委員會提交的最新年度和季度報告中的風險因素和管理層討論與分析部分中。

With that, I'd like to introduce our CEO, John Butler.

接下來，我想介紹我們的執行長約翰·巴特勒 (John Butler)。

Thanks, Mercedes, and thanks to everyone for joining us this morning. Since Vafseo vadadustat’s approval and even prior, I’ve spoken about our goal to make Vafseo a standard of care for patients with anemia due to chronic kidney disease. From my perspective, this endeavour has three parts. First, successfully launch Vafseo in dialysis during the TDAPA period. Second, continued growth in dialysis post TDAPA, potentially supported by the data, creating additional areas of differentiation.

謝謝，梅賽德斯，也謝謝大家今天早上加入我們。自從 Vafseo vadadustat 獲得批准以來，甚至更早之前，我就一直在談論我們的目標是讓 Vafseo 成為慢性腎臟病貧血患者的治療標準。從我的角度來看，這項努力包含三個部分。首先，在TDAPA期間成功推出Vafseo透析治療產品。其次，TDAPA 之後透析業務的持續成長可能得到數據的支持，從而創造出更多差異化的領域。

And third, approval and launch of Vafseo to treat anemia of CKD in patients who are not on dialysis. That’s the journey we’re on, and I’m proud to report the progress we’ve made in each area during the second quarter and to date in Q3. I continue to be incredibly pleased with the progress of our launch. We generated over $13 million in vascular revenue in Q2, with approximately $12 million in demand sales, a 55% increase over Q1.

第三，核准並推出Vafseo，用於治療未接受透析的CKD患者的貧血。這就是我們正在經歷的旅程，我很自豪地報告我們在第二季和第三季迄今為止在各個領域取得的進展。我對我們的發布進度感到非常高興。我們在第二季創造了超過 1,300 萬美元的血管收入，其中需求銷售額約為 1,200 萬美元，比第一季成長 55%。

In Q2, US Renal Care continued to represent the vast majority of our revenue. We appreciate their foresight partnership and ongoing commitment to delivering innovative therapies to patients. But we have to broaden that access to achieve our goals. While we’re pleased with the first two quarters of launch, we really only had access to about 40,000 dialysis patients during those months through USRC and other smaller dialysis organizations that operationalized the protocol to easily enable prescribing. In Q2, we had expected to have broader access at the other two midsized dialysis providers, DCI and IRC, the fourth and fifth largest dialysis provider. Today, I’m pleased to report that both are now completing their processes to make Vafseo available.

在第二季度，美國腎臟護理業務繼續占我們收入的絕大部分。我們感謝他們的遠見卓識的合作以及為患者提供創新療法的持續承諾。但我們必須拓寬這項管道才能實現我們的目標。雖然我們對發布的前兩個季度感到滿意，但在那幾個月裡，我們實際上只透過 USRC 和其他較小的透析組織接觸了大約 40,000 名透析患者，這些組織實施了該協議以輕鬆實現處方。在第二季度，我們預計將在其他兩家中型透析提供者 DCI 和 IRC（第四和第五大透析提供者）中獲得更廣泛的訪問。今天，我很高興地報告，兩家公司現在都已完成其使 Vafseo 可用的流程。

As of September, we expect the physicians at these dialysis organizations will be able to write a prescription for Vafseo without restriction, bringing the total patients with access to over 75,000. We believe this will enable a significant step up in growth. Even more significant from a volume and patient access perspective, DaVita, one of the largest dialysis providers, is completing preparations for its operational pilot for Vafseo. They've placed an initial order and expect patients to receive the drug starting in the middle of August.

截至 9 月，我們預計這些透析機構的醫生將能夠不受限制地開立 Vafseo 處方，使可以使用該藥物的患者總數達到 75,000 多人。我們相信這將推動成長取得顯著進步。從數量和患者訪問的角度來看，更重要的是，最大的透析提供者之一 DaVita 正在完成針對 Vafseo 的營運試點的準備工作。他們已經下了首批訂單，預計患者將從 8 月中旬開始收到該藥物。

Upon the successful completion of the pilot, we expect to increase patient access by more than sixfold from 40,000 patients in Q1 and Q2 to at least 275,000 patients later in Q4. Nick will give you more color on all of this launch progress and metrics. The second focus to drive Vafseo to become standard of care is to enhance the environment for growth post TDAPA. I'm very pleased to report the VOICE trial being conducted in collaboration with USRC has been fully enrolled as of late June.

在試驗成功完成後，我們預計患者就診人數將增加六倍以上，從第一季和第二季的 40,000 名患者增加到第四季度的至少 275,000 名患者。尼克將向您詳細介紹此次發布的進展和指標。推動 Vafseo 成為護理標準的第二個重點是增強 TDAPA 之後的成長環境。我很高興地報告，與 USRC 合作進行的 VOICE 試驗截至 6 月底已全部招募完畢。

Over 2,100 patients enrolled in only seven months. I believe this clearly speaks to investigators' interest in the potential benefits Vafseo may bring their patients and a desire to prove that dosing when administered during dialysis may be beneficial as well. The timing of enrolment completion is important, as it means the study will complete in late 2026 with data available in early 2027, shortly after the end of TDAPA. A VOICE and outcomes trial looking at all-cause mortality and all cause hospitalization. While its primary endpoint is non inferiority, it's power to demonstrate potential superiority for vadadustat for all cause hospitalization.

光是七個月就有超過 2,100 名患者報名。我相信這清楚地表明了研究人員對 Vafseo 可能為患者帶來的潛在益處的興趣，以及希望證明在透析期間給藥也可能有益。完成註冊的時間很重要，因為這意味著研究將於 2026 年底完成，數據將於 2027 年初（TDAPA 結束後不久）提供。VOICE 和結果試驗關注全因死亡率和全因住院率。雖然其主要終點是非劣效性，但它有能力證明 vadadustat 對於全因住院治療的潛在優勢。

We believe any data demonstrating a positive clinical outcome will be critical in establishing Vafseo as the standard of care. We're also pleased to have initiated VOCAL, a study looking at dosing of Vafseo three times a week, being performed in 18 DaVita dialysis facilities. This study will enroll about 350 patients. An important and exciting sub study will look at characteristics of red blood cells in patients treated with Vafseo. Now, previous studies have shown that other HIF-PHIs can improve the lifespan of red blood cell.

我們相信，任何證明積極臨床結果的數據對於確立 Vafseo 作為護理標準都至關重要。我們也很高興啟動了 VOCAL，這是一項研究每週三次使用 Vafseo 劑量的研究，目前在 18 家 DaVita 透析機構進行。這項研究將招募約350名患者。一項重要且令人興奮的子研究將觀察接受 Vafseo 治療的患者的紅血球特徵。現在，先前的研究顯示其他 HIF-PHI 可以延長紅血球的壽命。

I believe showing a potential positive impact on red blood cell characteristics size, lifespan, oxygen carrying capacity with Vafseo in a dialysis population can demonstrate the tangible differences, a more physiologic approach to treating anemia can yield. The third area of focus is securing an indication for non-dialysis patients in the Vafseo label. Recall that while the stage 4 and 5 non-dialysis population with anemia is roughly the same size as dialysis about 550,000 patients, it doesn't have the same pricing complexity that dialysis has in a post-TDAPA setting, making it potentially 4 to 5 times larger than the $1 billion addressable market size of the dialysis market.

我相信，Vafseo 對透析族群的紅血球特徵、大小、壽命、攜氧能力具有潛在的正面影響，可以證明明顯的差異，從而可以產生更符合生理的貧血治療方法。第三個重點領域是確保 Vafseo 標籤適用於非透析患者。回想一下，雖然患有貧血的 4 期和 5 期非透析人群的規模與透析患者的規模大致相同，約為 550,000 名患者，但它並不像 TDAPA 後透析那樣具有定價複雜性，因此它可能比透析市場 10 億美元的潛在市場規模大 4 到 5 倍。

We've continued to work to move this initiative forward. We completed a Type B meeting with the FDA in May. The meeting addressed a single focused written question to the agency related to the comparator arm for the VALOR trial in MDD CKD. Based on FDA written feedback, we’re now planning for an active ESA comparator. We believe this design will simplify the pooling of data with our prior Phase III US PROTECT program.

我們將繼續努力推動這項倡議向前發展。我們在五月與 FDA 完成了 B 類會議。會議向該機構提出了一個重點書面問題，該問題與 MDD CKD 中 VALOR 試驗的對照組有關。根據 FDA 的書面回饋，我們現在正在計劃開發一種活性 ESA 比較器。我們相信，這種設計將簡化我們先前的第三階段 US PROTECT 計畫的資料匯集。

We recently submitted a Type C meeting request to further discuss the study design, statistical analysis and both pooling strategy and we’re working to initiate VALOR by the end of the year. The team at Akebia believes strongly that patients not on dialysis would benefit from access to Vafseo and we’re working hard toward our goal to gain alignment with the FDA and be in a position to enroll the trial quickly.

我們最近提交了 C 類會議請求，以進一步討論研究設計、統計分析和匯總策略，我們正在努力在今年年底前啟動 VALOR。Akebia 團隊堅信，未接受透析的患者將受益於 Vafseo，我們正在努力實現與 FDA 保持一致的目標，並能夠迅速進行試驗。

With the launch of Vafseo and continued strong performance of Auryxia, we had over $60 million in net product revenue in Q2, the highest level in the history of the company. In a moment, Erik will talk to you about our strong second quarter financial results and solid financial position.

隨著 Vafseo 的推出和 Auryxia 的持續強勁表現，我們在第二季度實現了超過 6000 萬美元的淨產品收入，創下公司歷史上的最高水平。稍後，埃里克將與您討論我們強勁的第二季財務業績和穩固的財務狀況。

But first, let me turn it over to Nick to give more color on the Vafseo launch and what we’re learning in the field.

但首先，讓我把主題交給尼克，讓他更詳細地介紹一下 Vafseo 的發布以及我們在該領域的學習成果。

Thanks, John. Good morning, folks. As we work to build a new standard of care in treating CKD anemia in dialysis patients, we are taking a comprehensive and long-term view on how to establish a successful brand in a large category. To this end, we are rapidly advancing efforts across multiple work streams; which include building patient access, broadening physician prescribing and continuing physician education. We are making great progress on all fronts.

謝謝，約翰。大家早安。在我們致力於建立治療透析患者 CKD 貧血的新護理標準的同時，我們正在以全面和長遠的眼光看待如何在一個大的類別中建立一個成功的品牌。為此，我們正在迅速推進多個工作流程的努力，包括建立患者訪問權限、擴大醫生處方和繼續醫生教育。我們在各方面都取得了巨大進展。

Let me begin with some updates on prescription volumes. During the launch, we are focusing on breadth, the number of physicians prescribing and depth, the amount they are prescribing. We are very pleased to have 725 prescribers write within quarter two, up from approximately 640 in the first quarter.

首先，讓我介紹一下處方量的最新消息。在發布期間，我們關注的是廣度，即開處方的醫生數量，以及深度，即他們開處方的數量。我們非常高興地看到，第二季有 725 名開立處方的醫生，比第一季的約 640 名有所增加。

The prescribers are now writing an average of 13.3 prescriptions each, which is also an increase from the 12 prescriptions we reported in the first quarter. The breadth and depth of prescriptions are growing, but there is still more to do. I also want to touch on refills and average doses of Vafseo over time. Refills represented greater than 80% of prescriptions in quarter two and the average dose of those refills is up 28% from the starting dose.

現在，每位處方員平均開出 13.3 張處方，這也比我們第一季報告的 12 張處方有所增加。處方的廣度和深度正在不斷增長，但仍有許多工作要做。我還想談談 Vafseo 的補充和平均劑量隨時間的變化。在第二季度，續藥佔處方的 80% 以上，續藥的平均劑量比起始劑量增加了 28%。

We believe this reflects that physicians are getting comfortable treating patients at an optimal therapeutic dose and as a result, each of our prescriptions becomes more valuable. Upon market availability, we had expected the frequency and intensity of dialysis patient care would have resulted in a higher than typical adherence rate for Vafseo.

我們相信，這反映出醫生越來越習慣以最佳治療劑量治療患者，因此，我們的每張處方都變得更有價值。一旦市場有庫存，我們預計透析患者護理的頻率和強度將導致 Vafseo 的依從率高於典型水平。

As we have now been out in the field since January, we have observed adherence rates consistent with the industry at 70% to 80%. As we saw in our clinical trials, some patients, especially those on higher doses of ESAs, experienced a hemoglobin drop on transitioning to 300 milligram starting dose of Vafseo. This is a departure from the experience with today’s standard of care and anemia managers are conditioned to react as quickly as possible to a hemoglobin drop.

自一月份以來，我們一直在該領域工作，觀察到遵守率與行業一致，為 70% 至 80%。正如我們在臨床試驗中看到的那樣，一些患者，尤其是那些服用較高劑量 ESA 的患者，在轉換為 300 毫克起始劑量的 Vafseo 時會出現血紅蛋白下降。這與當今的護理標準經驗不同，貧血管理人員習慣對血紅蛋白下降盡快做出反應。

In some cases, anemia managers did not detect a titrate for the protocol and patients were moved back to their prior ESAs. I am proud of how quickly the Akebia team and our partners reacted to improve adherence. We quickly revamped and highlighted our messaging focusing on dosing and titration, we worked with existing customers to adjust protocols and we educated dialysis organizations who are developing protocols to consider this in their protocol design.

在某些情況下，貧血管理人員沒有檢測到方案的滴定，因此患者被轉移回先前的 ESA。我為 Akebia 團隊和我們的合作夥伴為提高依從性所做的快速反應感到自豪。我們迅速修改並強調了以劑量和滴定為重點的信息，我們與現有客戶合作調整協議，並教育正在製定協議的透析組織在其協議設計中考慮到這一點。

We believe our messages on improving adherence are getting out there and taking effect. Our focus ahead is to accelerate growth by increasing utilization and additional deals by enabling nephrologists with access to write prescriptions. I would like to spend a minute providing more detail on our progress. As we have discussed previously, we have commercial contracts in place with all key dialysis organizations and group purchasing organizations covering nearly 100% of dialysis patients. That was step one.

我們相信，我們關於提高依從性的信息正在傳播並產生效果。我們未來的重點是透過提高利用率和增加交易來加速成長，使腎病專家能夠開處方。我想花一點時間來詳細介紹我們的進展。正如我們之前所討論的，我們與所有主要的透析組織和團體採購組織簽訂了商業合同，涵蓋了幾乎 100% 的透析患者。這是第一步。

We are also supporting dialysis organizations in the creation and operationalization of Vafseo treatment protocols. I will refer to this as prescribing access. As John mentioned, we have prescribing access to over 40,000 dialysis patients in the first half of the year resulting in most of our orders since launch coming from USRC.

我們也支持透析組織創建和實施 Vafseo 治療方案。我將把這稱為規定存取權限。正如約翰所提到的，今年上半年我們已經為超過 40,000 名透析患者提供了處方，因此自推出以來我們的大部分訂單都來自 USRC。

Within the next month, we will have prescribing access to over 75,000 dialysis patients, an increase of over 85% which includes DCI, IRC and many independent and small dialysis organizations. Momentum around protocol development and implementation is picking up further in the third quarter as DaVita physicians will begin prescribing Vafseo as part of its operational pattern at more than 100 dialysis clinics. With large complex systems, it always makes sense to do a test run to ensure a smooth rollout.

下個月內，我們將為超過 75,000 名透析患者提供處方，成長超過 85%，其中包括 DCI、IRC 和許多獨立和小型透析組織。隨著 DaVita 醫生開始在 100 多家透析診所開立 Vafseo 作為其營運模式的一部分，第三季協議制定和實施的勢頭將進一步增強。對於大型複雜系統，進行試運行以確保順利推出總是有意義的。

That’s exactly what DaVita is doing. Activity around the pilot has already begun as DaVita notified the selected pilot sites, ordered product in July to support early pilot prescribing and began training their staff. The pilot is expected to conclude within approximately three months, which we believe will increase total prescribing access for Vafseo to over 275,000 dialysis patients and enable the opportunity for a significant uptick in ordering in the fourth quarter of the year within DaVita.

這正是 DaVita 正在做的事情。隨著 DaVita 通知選定的試點地點、在 7 月訂購產品以支持早期試點處方並開始培訓其員工，圍繞試點的活動已經開始。預計試點將在大約三個月內完成，我們相信這將使 Vafseo 的總處方覆蓋範圍擴大到超過 275,000 名透析患者，並使 DaVita 內部在今年第四季度的訂購量有機會大幅增加。

One additional important note on patient access. In discussions with dialysis organizations with protocols in place and a review of claims data, we’ve confirmed that a significant number of Medicare Advantage plans are covering Vafseo. As a reminder, patients covered by Medicare fee-for-service represent 35% to 40% of dialysis patients and Medicare Advantage another 35% to 40% of patients. Therefore, depending on the dialysis organization, the addressable patient population for Vafseo could be double and potentially up to 80% of all dialysis patients having reimbursement for Vafseo. Looking at the totality of our efforts, we’re happy with the progress on growing breadth and depth of prescribing, increasing patient access and physician education.

關於患者訪問的另一個重要注意事項。在與制定了協議的透析組織進行討論並審查索賠數據後，我們確認大量 Medicare Advantage 計劃涵蓋了 Vafseo。提醒一下，享有醫療保險按服務收費的患者佔透析患者的 35% 至 40%，而享有醫療保險優勢計劃的患者佔透析患者的另外 35% 至 40%。因此，根據透析機構的不同，Vafseo 可覆蓋的患者群體可能會增加一倍，並且可能佔所有透析患者的 80%，所有透析患者都可以透過 Vafseo 獲得報銷。縱觀我們所做的全部努力，我們對擴大處方廣度和深度、增加患者就醫機會和醫生教育方面的進展感到滿意。

We have increased demand 55% quarter-over-quarter. We expect to meaningfully increase prescribing access from approximately 40,000 patients to over 75,000 patients in the third quarter. And we are on track to access DaVita, which we expect to lead to prescribing access to over 275,000 dialysis patients in quarter four. We’re still in the early stages of our goal to build a new standard of care, but we believe we are on track to make our goal a reality.

我們的需求較上季成長了 55%。我們預計第三季獲得處方的患者數量將從約 40,000 名大幅增加至超過 75,000 名。我們正在按計劃接入 DaVita，預計第四季度將為超過 275,000 名透析患者提供處方服務。我們仍處於建立新護理標準目標的早期階段，但我們相信我們正朝著實現目標的方向前進。

Let me now turn it over to Erik.

現在讓我把它交給艾瑞克。

Thanks, Nick. We’re happy to report another strong quarter driven by the top line performance of both Vafseo and Auryxia. I will now provide an overview of our results as compared to the second quarter of last year.

謝謝，尼克。我們很高興地報告，在 Vafseo 和 Auryxia 的營收表現的推動下，本季又迎來了強勁成長。現在我將概述我們與去年第二季相比的業績。

Total revenues, which are comprised primarily of net product revenues and also include license collaboration and other revenues, were $62.5 million this quarter as compared to $43.6 million in Q2 of last year representing an increase of $18.9 million. Of these amounts, net product revenues increased to $60.5 million this quarter from $41.2 million in Q2 of last year. This was driven by sales of Vafseo which, as mentioned, were $13.3 million in the quarter as well as by an increase in Auryxia sales, which were $47.2 million this quarter as compared to $41.2 million in Q2 of last year.

總收入主要包括淨產品收入，也包括許可合作和其他收入，本季總收入為 6,250 萬美元，而去年第二季為 4,360 萬美元，增加了 1,890 萬美元。其中，淨產品收入從去年第二季的 4,120 萬美元增至本季的 6,050 萬美元。這是由於 Vafseo 的銷售額（如上所述）本季為 1,330 萬美元，以及 Auryxia 銷售額的成長，本季為 4,720 萬美元，而去年第二季為 4,120 萬美元。

As a reminder, Auryxia lost IP exclusivity in March and there is an authorized generic for Auryxia on the market though no generics have been approved by the FDA at this time. We are pleased with this quarter’s strong Auryxia results though caution future Auryxia sales levels are challenging to predict due to the uncertainty around the timing of potential additional generic competition. Cost of goods sold decreased to $9.9 million this quarter as compared to $17 million in Q2 of last year.

提醒一下，Auryxia 在 3 月失去了 IP 獨佔權，市場上已經有 Auryxia 的授權仿製藥，儘管目前 FDA 尚未批准任何仿製藥。我們對本季度 Auryxia 的強勁業績感到滿意，但由於潛在的額外仿製藥競爭時機的不確定性，未來 Auryxia 的銷售水平難以預測。本季銷售成本下降至 990 萬美元，去年第二季為 1,700 萬美元。

The key driver of this COGs reduction is that we are no longer reporting a $9 million quarterly noncash amortization charge related to the acquired development product rights for Auryxia, which is now fully emphasized. Also of note, Vafseo sales in the quarter were derived from prelaunch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related costs were previously expensed to R&D prior to Vafseo’s FDA approval. R&D expenses increased to $11 million this quarter from $7.6 million in Q2 of last year driven by increased clinical trial activities related to Vafseo as well as our other programs. SG&A expenses decreased slightly to $26.6 million this quarter from $26.9 million in Q2 last year.

降低 COG 的關鍵驅動因素是我們不再報告與收購 Auryxia 開發產品權利相關的 900 萬美元季度非現金攤銷費用，現在該費用已得到充分強調。另外值得注意的是，Vafseo 本季的銷售額來自上市前庫存，其中不包括全部製造成本，因為在 Vafseo 獲得 FDA 批准之前，這些庫存相關成本的一部分已計入研發費用。由於與 Vafseo 以及我們的其他項目相關的臨床試驗活動增加，研發費用從去年第二季的 760 萬美元增加到本季的 1,100 萬美元。銷售、一般及行政費用 (SG&A) 從去年第二季的 2,690 萬美元略微下降至本季的 2,660 萬美元。

Turning to the bottom line, we generated $247,000 of net income this quarter as compared to a net loss of $8.6 million in Q2 of last year. This quarter’s net income was driven by the increase in revenues, which was partially offset by $5.4 million of interest expense related to the Vifor settlement royalty liability as well as $7 million in noncash expense related to the change in fair value of our warrant liability, which was driven by the increase in our stock price in Q2 over the prior quarter.

談到底線，本季我們創造了 247,000 美元的淨收入，而去年第二季的淨虧損為 860 萬美元。本季的淨收入是由收入增加所推動的，但部分被與 Vifor 結算特許權使用費負債相關的 540 萬美元利息費用以及與認股權證負債公允價值變動相關的 700 萬美元非現金費用所抵消，而認股權證負債的公允價值變動是由我們第二季的股價變動較上一季度上漲所推動的股價。

We ended Q2 with $137.3 million in cash and cash equivalents. We believe our existing cash resources and the cash we expect to generate for product, royalty, supply and license revenues are sufficient to fund our current operating plan to profitability, including to pursue label expansion for Vafseo and advance our other pipeline programs.

我們第二季結束時的現金和現金等價物為 1.373 億美元。我們相信，我們現有的現金資源以及我們預計將從產品、特許權使用費、供應和許可收入中產生的現金足以支持我們目前的營運計劃以實現盈利，包括追求 Vafseo 的標籤擴張和推進我們的其他管道計劃。

In closing, our Q2 financials reflect increased uptake of Vafseo, continued resilience of the Auryxia revenue stream and careful attention to operating expenses, which resulted in our strengthened financial position. As John and Nick mentioned, the team is dedicating significant energy towards continuing to expand both the breadth and depth of Vafseo utilization and we look forward to discussing the results of these efforts on our next earnings call.

最後，我們的第二季財務狀況反映出 Vafseo 的吸收量增加、Auryxia 收入流的持續彈性以及對營運費用的密切關注，這導致我們的財務狀況得到加強。正如約翰和尼克所提到的，團隊正在投入大量精力繼續擴大 Vafseo 利用的廣度和深度，我們期待在下次財報電話會議上討論這些努力的成果。

With that, we welcome questions.

我們歡迎您提出問題。

(Operator Instructions)

（操作員指示）

Roger Song, Jefferies.

傑富瑞的羅傑‧宋 (Roger Song)。

Congrats for the quarter. You gave us a lot of good numbers here. Just want to get a sense of some of the key metrics here. So first is the patient segment. So in terms of the home use and high ESA, what do you see this quarter and how this changed over last quarter?

恭喜本季。您在這裡給了我們很多好的數字。只是想了解這裡的一些關鍵指標。首先是患者部分。那麼就家庭使用和高 ESA 而言，您對本季有何看法？與上一季相比有何變化？

And then also how do you forward looking when you have more larger DO coming online, including DaVita in 4Q, you see the patient segment will change? Similarly for the payer, you say the Medicare Advantage seems to be a significant amount of the patient. Can you quantify compared to the fee-for-service? And I have a follow-up. Thank you.

那麼，當有更多更大的 DO 上線時，包括第四季度的 DaVita，您如何看待患者群體的變化？同樣，對於付款人來說，您說醫療保險優勢計劃似乎佔了患者的很大一部分。與按服務收費相比，您能量化嗎？我還有一個後續問題。謝謝。

Nick, I think that’s for you.

尼克，我想這很適合你。

Yes. So when we think about the patient segmentation, it’s a great question, and where USRC who is a vast majority of our prescriptions, their protocol is broad. They’re allowing PD use for both in-center patients and home patients. And we see usage that is very much similar to the market segmentation between PD and home patients being about 12% of the total scripts and the remainder being for in-center patients.

是的。因此，當我們考慮患者細分時，這是一個很好的問題，而 USRC 占我們處方的絕大多數，他們的方案很廣泛。他們允許中心患者和家庭患者使用 PD。我們發現使用情況與 PD 和家庭患者之間的市場細分非常相似，約佔總處方的 12%，其餘的則是中心患者。

The second part of that is how do we see that moving forward when we add on DaVita and others in the third and fourth quarter. When we look at all of the protocols that they’re putting in place, whether it be IRC, ECI or DaVita, they’re all broad protocols that allow for both in-center and home use. When physicians think about patients top of mind that will benefit from Vafseo, they go to two important segments first.

第二部分是，當我們在第三和第四季增加 DaVita 和其他人時，我們如何看待未來的發展。當我們查看他們實施的所有協議時，無論是 IRC、ECI 還是 DaVita，它們都是允許在中心和家庭使用的廣泛協議。當醫生考慮最能從 Vafseo 中受益的患者時，他們首先會考慮兩個重要部分。

They go to the home patient where it makes really good sense to use an oral therapy for those patients to avoid injections as well as consistent visits to the dialysis unit and they also think about higher dose ESA patients who have a higher increased mortality and cardiovascular risk associated with this higher dose of ESA. And so, we expect to have continued broad uses. It may tip a little bit higher towards the PD section or the home section, but expect consistency moving forward given those broad protocols.

他們去到家庭病人那裡，對那些病人來說，使用口服療法是非常有意義的，這樣可以避免注射以及經常去透析室，他們還考慮到高劑量 ESA 的患者，這些患者的死亡率和心血管風險會因高劑量 ESA 而增加。因此，我們期望其能夠繼續得到廣泛的應用。它可能會向 PD 部分或家庭部分傾斜一點，但考慮到這些廣泛的協議，預計未來會保持一致。

The second part of your question was on market access and Medicare Advantage. To date, we’re seeing about 20% of total prescriptions being filled in the Medicare Advantage segment of the population where 80% is Medicare fee-for-service. But as we look going forward, in our discussions with again, IRC and BCI, and DaVita, they have all indicated to have significant Medicare Advantage contracts already in place that will support Vafseo through additional TDAPA coverage.

問題的第二部分是關於市場准入和醫療保險優勢計劃。到目前為止，我們看到大約 20% 的總處方是由醫療保險優勢人群填寫的，其中 80% 是醫療保險按服務收費的。但展望未來，在我們與 IRC、BCI 和 DaVita 的討論中，他們都表示已經簽訂了重要的 Medicare Advantage 合同，這些合同將通過額外的 TDAPA 保險為 Vafseo 提供支持。

And so, that’s a great sign. That means that those populations are growing over our initial expectations of fee-for-service and they’re growing at a faster rate. We always thought they would add Medicare Advantage plans over time. It’s happened much earlier than we could have anticipated. I think even with US Renal where they started with mostly a focus on fee-for-service, as that Medicare Advantage coverage has grown, they’ve kind of pushed those patient needs out to the dialysis centers as well, right? So there’s still growth to be had clearly within US Renal.

所以，這是一個好兆頭。這意味著這些人群的成長速度超過了我們最初對按服務收費的預期，而且成長速度更快。我們一直認為他們會隨著時間的推移增加醫療保險優勢計劃。這件事發生得比我們預期的早得多。我認為，即使美國腎臟病中心最初主要側重於按服務收費，但隨著醫療保險優勢計劃覆蓋範圍的擴大，他們也已經將患者的需求轉移到了透析中心，對嗎？因此，美國腎臟病領域顯然仍有成長空間。

That’s correct. When I think about US Renal, over 80% of US Renal care physicians are writing, which is an important metric especially when new coverage becomes available. When that new coverage becomes available, those physicians have the opportunity to treat Vafseo to a broader population that is in need of Vafseo that previously didn’t have coverage. So we’re looking forward to continued access increases and look forward to driving deeper penetration within all accounts.

沒錯。當我想到美國腎臟病時，超過 80% 的美國腎臟護理醫生都在寫作，這是一個重要的指標，尤其是在有新的保險覆蓋時。當新的保險覆蓋範圍可用時，這些醫生就有機會為更廣泛的需要 Vafseo 治療但以前沒有保險的人群提供 Vafseo 治療。因此，我們期待訪問量持續增加，並期待推動所有帳戶的更深層次滲透。

Just a quick one. And then what’s the current average dose strength for your prescription because you see a higher dose level in the recent trend. Thank you.

只是快速的。那麼，您處方的當前平均劑量強度是多少，因為您看到最近的趨勢是劑量水平較高。謝謝。

Nick, I think that's you again.

尼克，我想那又是你。

Yes. And so as I referred to in my script, we’re seeing refill scripts being at about a 28% increase over the 300 milligram starting dose, which is great. We saw in our INNOVATE clinical trial that folks got to approximately an average of 420 milligrams per script and so that would be, call it a 40% increase. We’re at 25% increase or 28% increase to date.

是的。正如我在處方中提到的，我們發現續藥處方比 300 毫克的起始劑量增加了約 28%，這很好。我們在 INNOVATE 臨床試驗中發現，人們平均每份處方的劑量約為 420 毫克，也就是說增加了 40%。到目前為止，我們的增幅為 25% 或 28%。

So we see as people progress through their prescriptions from first prescription to second prescription, third prescription, those doses continue to titrate up. As you recall, our label has people titrating up at 150 milligrams after four weeks and every four weeks thereafter. Therefore, it’s going to take the second or third refill to get them to the appropriate dose in some cases.

因此，我們看到，隨著人們從第一個處方到第二個處方、第三個處方的進展，這些劑量不斷增加。您還記得，我們​​的標籤上寫著，四周後劑量增加到 150 毫克，之後每四周增加一次。因此，在某些情況下，需要第二次或第三次補充才能達到適當的劑量。

And I think when you mentioned the adherence changes, I mean, what some providers are doing is actually allowing titration at week two, which we saw in the modified trial as well. So I mean, the one thing to be aware of as you bring on new dialysis providers and they bring on more new patients and we see the step-up in patients, you may actually see a bit of a step down in dose because you have more patients at that starting dose. That’s exactly what we would hope to see. But as they stay on the drug, they’ll titrate to that average dose. And that’s obviously, as you can see, an important component of our growth in the quarter.

我認為，當您提到依從性變化時，我的意思是，一些提供者實際上正在做的是允許在第二週進行滴定，我們在修改後的試驗中也看到了這一點。所以我的意思是，要注意的一件事是，當你引入新的透析提供者並且他們帶來更多的新患者時，我們看到患者數量的增加，你實際上可能會看到劑量略有下降，因為你有更多的患者處於起始劑量。這正是我們希望看到的。但隨著他們繼續服用該藥物，他們會逐漸增加劑量至平均劑量。如您所見，這顯然是我們本季成長的重要組成部分。

Julian Harrison, BTIG

朱利安·哈里森（Julian Harrison），BTIG

On the operationalized protocol you’re expecting from DaVita, is that expected to be implemented in early or late fourth quarter? Are you able to provide any granularity there? And when we start to think about the other large dialysis organization of comparable size to DaVita, should we also expect that corresponding protocol to be preceded by a pilot study as well?

關於您期望 DaVita 實施的實施協議，預計在第四季初還是末期實施？您能提供任何詳細資訊嗎？當我們開始考慮與 DaVita 規模相當的其他大型透析組織時，我們是否也應該期望相應的協議在試點研究之前進行？

Yes. Great question, Julian. So the DaVita operational pilot is they are preparing for it now and they’ve ordered the product, they’re training at the sites. And we expect in the next couple of weeks, I think the 18th of the month is when they expect to go live with it and that pilot will last three months. So up to three months, obviously it could go sooner. But I think the expectation should be around the middle of November is when they basically open that up to the entire DaVita network.

是的。好問題，朱利安。因此，他們現在正在為 DaVita 營運試點做準備，他們已經訂購了產品，並正在現場進行培訓。我們預計在接下來的幾週內，我想他們預計將在本月 18 日開始實施該功能，並且該試點將持續三個月。所以最多三個月，顯然也可以更早。但我認為預計應該在 11 月中旬左右向整個 DaVita 網路開放。

And as you mentioned the other large providers Fresenius of course. We continue to talk to Fresenius, present them clinical data, et cetera. We have not been able to progress yet. I think as DaVita comes on and all of these other providers come on, it becomes more and more difficult for them to keep access from their physicians and patients for this innovative product.

當然，正如您所提到的，其他大型供應商還有費森尤斯 (Fresenius)。我們繼續與費森尤斯進行溝通，向他們提供臨床數據等等。我們尚未取得進展。我認為，隨著 DaVita 和所有其他供應商的出現，他們將越來越難以阻止醫生和患者獲得這種創新產品。

My expectation, Nick can correct me if I’m wrong, is they would probably do a similar kind of operational pilot before they get broad access.

我的期望是，他們可能會在獲得廣泛使用權之前進行類似的操作試點，如果我錯了，尼克可以糾正我。

And then a follow-up, if I may. On nondialysis-dependent CKD, it sounds like you’re very close to finalizing the Phase III trial design for VALOR. Are you able to give us an approximate sense for how soon this label expansion opportunity could come online for Vafseo? What does the timeline look like after that study starts around year-end?

如果可以的話，我接下來再進行跟進。關於非透析依賴性 CKD，聽起來您已經非常接近完成 VALOR 的 III 期試驗設計。您能否大致告訴我們，Vafseo 多久能迎來這個品牌擴展機會？該研究在年底開始後，時間表是什麼樣的？

So the timeline is going to be driven significantly by how quickly we can enroll the study, right? I mean it’s an outcome study. We still expect -- again, all of these details are somewhat to be determined. But the numbers we’ve been giving in the past about a 1,500 patient trial now with an active comparator versus Vafseo vadadustat and doing it strictly in the US with US patients.

因此時間表將很大程度上取決於我們進行研究的速度，對嗎？我的意思是這是一項結果研究。我們仍然期待——再次強調，所有這些細節都有待確定。但我們過去給出的數據是，現在對 1,500 名患者進行了試驗，並使用活性對照藥物與 Vafseo vadadustat 進行比較，並且嚴格地在美國對美國患者進行試驗。

So we can do that pooling of VALOR with the US PROTECT data to enhance the comfort that there isn’t an increased MACE risk, which of course we didn’t see in the US patients with PROTECT. It’s really all about how quickly we can enroll and getting a sense of that before we know what the final protocol looks like. I mean this is one of the activities that we’re doing to prepare is working on feasibility.

因此，我們可以將 VALOR 與美國 PROTECT 數據匯總，以增強人們的信心，確保 MACE 風險不會增加，當然，我們在接受 PROTECT 治療的美國患者中沒有看到這種情況。這實際上取決於我們能多快地進行註冊，並在我們知道最終協議是什麼樣子之前了解這一點。我的意思是，這是我們正在進行的準備活動之一，旨在實現可行性。

How many sites, how many patients per site and that will help us to better inform you but I don’t want to get ahead of that data yet. But obviously our goal would be to enroll as quickly as possible.

有多少個站點，每個站點有多少患者，這將有助於我們更好地通知您，但我還不想領先這些數據。但顯然我們的目標是盡快招生。

Mazi Ali Mohamed, Leerink Partners

Mazi Ali Mohamed，Leerink Partners

This is Mazi on for Roanna Ruiz. So Auryxia revenues actually grew year from year. So I guess one question is with the only one authorized generic currently in the market, what’s your outlook for competitive dynamics over the remainder of 2025? And I guess how are you thinking about positioning for additional generic entrants in the future?

這是 Mazi 為 Roanna Ruiz 表演的。因此，Auryxia 的收入實際上逐年增長。所以我想問一個問題是，目前市場上只有一種授權仿製藥，您對 2025 年剩餘時間的競爭動態有何展望？我想問一下，您如何考慮未來針對其他通用藥物的定位？

Thanks for the question. Nick, maybe you can kind of talk about the market dynamics and why we’re seeing that growth.

謝謝你的提問。尼克，也許你可以談談市場動態以及我們為什麼會看到這種成長。

Yes. The market dynamics, it’s great news for Auryxia. It’s really built on the back of Auryxia is a 10-year-old product and physicians are very comfortable with the clinical profile and the benefits of Auryxia as we’ve been kind of working with physicians for the last 10 years. When we think about Auryxia prebundle, the market or the access for Auryxia was actually extremely limited in prior years. Physicians often had to do a prior auth.

是的。市場動態對 Auryxia 來說是個好消息。它實際上是建立在 Auryxia 的基礎上的，Auryxia 是一款已有 10 年歷史的產品，醫生對 Auryxia 的臨床概況和益處非常滿意，因為我們在過去 10 年裡一直與醫生合作。當我們考慮 Auryxia 捆綁前期時，Auryxia 的市場或訪問管道在前幾年實際上極其有限。醫生通常必須事先進行授權。

In some cases, they had to do a medical exception and they didn’t want to really do the work consistently for their patients. Now that the bundle has been implemented, access for Auryxia is actually at one of its greatest points in its history. And so the physicians who are very comfortable using the product to understand its benefits and patients are taking the opportunity with that increased access to put more patients on Auryxia, which is great news for Auryxia.

在某些情況下，他們不得不做出醫療例外，而且他們不想真正持續地為患者做這項工作。現在，該捆綁包已經實施，Auryxia 的訪問實際上正處於其歷史上最偉大的時刻之一。因此，非常樂意使用該產品的醫生了解其益處，而患者則利用這一機會讓更多的患者使用 Auryxia，這對 Auryxia 來說是個好消息。

And so when we think about that trend continuing maybe for the AG pieces, I’ll pass it over to Erik or back to John to go into that piece.

因此，當我們考慮這種趨勢可能繼續適用於 AG 作品時，我會將其交給 Erik 或交還給 John 來討論作品。

Well, I mean I think, as you said, we have one AG on the market. We know exactly how much product we’re supplying to Viatris and how long that supply agreement really only goes through this year. So we really need to see what happens with FDA. We’ve always had to be very careful about how we think about the long term with Auryxia because ultimately we believe that the product will be approved.

嗯，我的意思是，我認為，正如你所說，我們在市場上有一個 AG。我們清楚地知道我們向 Viatris 供應了多少產品，以及該供應協議今年實際上只有效多長時間。所以我們真的需要看看 FDA 會發生什麼。我們始終必須非常謹慎地考慮 Auryxia 的長期發展，因為我們相信該產品最終會獲得批准。

We’ve been saying for years that the slope of that curve post generic availability isn’t necessarily that patent cliff that you always see. If you use Sevelamer as an example, it took years before the generics took the lion’s share of the market because of the volume that you have to manufacture here. But we look at it in a very conservative way. And maybe I’ll pass that to Erik to talk about it more.

多年來，我們一直在說，仿製藥上市後的曲線斜率不一定是我們經常看到的專利懸崖。如果以 Sevelamer 為例，由於生產量龐大，仿製藥需要花費數年時間才能佔據市場的最大份額。但我們以非常保守的方式看待它。也許我會把這個轉達給艾瑞克，讓他進一步討論。

Yes. No, I totally agree with John. From an internal perspective due to the reasons we alluded to in the script as well in my comments, new generic competition could come up at any time. So we budget conservatively and the longer we go without that incremental generic competition is really just upside to our internal.

是的。不，我完全同意約翰的觀點。從內部角度來看，由於我們在腳本中以及我的評論中提到的原因，新的通用競爭可能隨時出現。因此，我們保守地制定預算，越長時間沒有這種漸進式的通用競爭，對我們的內部來說實際上就越有利。

Yes. And when we talk about our kind of the cash runway, et cetera, of being able to finance our pipeline, it’s using a very conservative view of where Auryxia lands over time. But we’re four months post when we had originally planned to have generics available. So we’re pleased every day to continue to be able to deliver the product to patients.

是的。當我們談論我們的現金流等等，談論我們能夠為我們的管道提供資金的能力時，我們對 Auryxia 未來發展方向的看法非常保守。但我們比原計劃推出仿製藥的時間晚了四個月。因此，我們很高興每天都能夠繼續向患者提供產品。

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

謝謝。我目前沒有其他問題。我想把發言權交還給約翰·巴特勒，請他做最後的總結發言。

Thanks, Victor, and thanks, everyone, for joining us this morning. We’re focused on our goal of making Vafseo standard of care for treating anemia due to CKD. We’re making important progress across all components of that strategy. Our launch is accelerating. We’re executing the studies in dialysis patients to continue to build evidence of potential benefits and we’re planning to initiate our MDD study VALOR this year.

謝謝維克多，也謝謝大家今天早上加入我們。我們專注於使 Vafseo 成為治療 CKD 引起的貧血的標準護理目標。我們在該戰略的所有組成部分上都取得了重要進展。我們的發布正在加速進行。我們正在對透析患者進行研究，以繼續收集潛在益處的證據，並計劃今年啟動 MDD 研究 VALOR。

Our revenue performance and cash balance allow us to execute the strategy and advance our early pipeline from a position of financial strength. We look forward to continuing to update you on our progress. Have a great day.

我們的收入表現和現金餘額使我們能夠執行該策略，並從財務實力的角度推進我們的早期管道。我們期待繼續向您通報我們的進展。祝你有美好的一天。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。祝大家有個愉快的一天。