Akebia Therapeutics Inc (AKBA) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Akebia first quarter 2025 financial results conference call.

您好，感謝您的支持。歡迎參加 Akebia 2025 年第一季財務業績電話會議。

(Operator Instructions)

（操作員指示）

I would now like to hand the conference over to your first speaker for today, Ms. Mercedes Carrasco, Senior Director of Investor relations. Please go ahead.

現在，我想將會議交給今天的第一位發言者，投資者關係高級總監 Mercedes Carrasco 女士。請繼續。

Thank you and welcome to Akebia's first quarter 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, May 8th, detailing our first quarter 2025 financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude.

感謝您並歡迎參加 Akebia 2025 年第一季財務業績和業務更新電話會議。請注意，我們在今天早些時候（5 月 8 日星期四）發布了一份新聞稿，詳細介紹了我們 2025 年第一季的財務業績，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。

Joining me for today's call, we have John Butler, Chief Executive Officer, Nicholas Grund, Chief Commercial Officer, and Eric Ostrovsky, Chief Financial and Chief Business Officer.

參加今天電話會議的還有執行長約翰·巴特勒 (John Butler)、首席商務官尼古拉斯·格倫德 (Nicholas Grund) 和首席財務兼首席商務官埃里克·奧斯特洛夫斯基 (Eric Ostrovsky)。

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 are included in the financial results press release that we issued on May 8th as well as in the risk factors and management discussion and analysis section of our most annual report and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO John Butler.

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 5 月 8 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年度報告和季度報告中的風險因素和管理討論與分析部分中。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. Well, during our last call, we shared initial progress on our Vafseo vadadustat US product launch, and I'm extremely pleased to report we continued our strong performance. We delivered US net product revenues of $12 million versus our guidance of $10 to $11 million in the first quarter. I believe our strong early performance is a reflection of nephrologists' desire for a new treatment option to treat anemia in CKD patients on dialysis.

謝謝，梅賽德斯，也謝謝大家今天早上加入我們。嗯，在我們上次電話會議中，我們分享了 Vafseo vadadustat 美國產品發布的初步進展，我非常高興地報告我們繼續保持強勁的表現。我們第一季的美國淨產品收入為 1200 萬美元，而我們的預期為 1000 萬至 1100 萬美元。我相信我們早期的強勁表現反映了腎臟病專家對治療透析 CKD 患者貧血的新治療方案的渴望。

Though I continue to express caution that we're in the early stages of product introduction, it is one of the strongest launches I've ever seen in the dialysis market. I want to acknowledge the excellent job our commercial and medical affairs teams are doing, educating dialysis providers, prescribers, anemia managers, and other members of the patient care team about Vafseo.

儘管我仍然謹慎地表示我們正處於產品推出的早期階段，但這是我在透析市場上見過的最強勁的產品發布之一。我要承認我們的商業和醫療事務團隊所做的出色工作，他們向透析提供者、處方者、貧血管理人員和其他患者護理團隊成員介紹了 Vafseo。

The complexity of selling a product in the dialysis market should never be underestimated, but our strategy to build prescriber demand and quickly transition patients onto Vafseo is playing out as planned. Importantly, we're also encouraged to see that patients are staying on therapy as evidenced by the growing number of refills being written and as expected, we're also seeing the utilization of higher doses as patients' doses are titrated to achieve and maintain appropriate hemoglobin levels. As we've said in the past, we have commercial contracts in place with dialysis organizations covering nearly 100% of dialysis patients.

永遠不要低估在透析市場銷售產品的複雜性，但我們建立處方需求並快速讓患者轉向 Vafseo 的策略正在按計劃進行。重要的是，我們也很高興地看到，患者正在堅持接受治療，證據是續藥數量不斷增加，並且正如預期的那樣，隨著患者的劑量被滴定以達到並維持適當的血紅蛋白水平，我們也看到使用更高劑量。正如我們過去所說，我們與透析機構簽訂了商業合同，涵蓋了幾乎 100% 的透析患者。

The top five dialysis organizations have now ordered Vafseo. However, nearly all the revenues still coming from the small to mid-size dialysis organizations who treat approximately 150,000 patients collectively. One of the large dialysis providers is planning a large pilot to operationalize its protocol. We expect that pilot to begin in the third quarter. The other large provider is earlier in their process, but I'm encouraged that they're making the product available on an exception basis for patients.

目前，全球五大透析機構均已訂購 Vafseo。然而，幾乎所有的收入仍然來自總共治療約 15 萬名患者的中小型透析機構。一家大型透析服務提供者正在計劃進行大規模試點以實施其協議。我們預計該試點將於第三季開始。另一家大型供應商的流程較早，但我很高興他們能夠為患者提供例外產品。

Given that each LGO treats over 200,000 patients, bringing one on board with a broad protocol will more than double the number of patients with access to Bassio. Now shifting gears, the voice study in collaboration with US renal care continues to march towards full enrollment and now has about 75% of patients enrolled. As you recall, the target enrollment is approximately 2,200 subjects. In just five months of enrollment, this is tremendous progress.

鑑於每家 LGO 治療超過 20 萬名患者，因此，引入一家採用廣泛協議的 LGO 將使能夠接受 Bassio 治療的患者數量增加一倍以上。現在，與美國腎臟護理中心合作的聲音研究正在轉變方向，繼續向全面招募邁進，目前已有約 75% 的患者招募。您還記得，目標招生人數約 2,200 名。入學僅五個月，這是一個巨大的進步。

We believe voice could generate data on the benefits associated with Vafseo treatment, including potential improvements in hospitalization, which is critical information for prescribers and dialysis organizations. We also continue to pursue an approval of Vafseo in the non-dialysis patient population and remain on track with our goal to initiate our Phase III VALOR trial in NDD in the second half of 2025.

我們相信語音可以產生與 Vafseo 治療相關的益處的數據，包括住院治療的潛在改善，這對於處方者和透析組織來說是至關重要的訊息。我們也將繼續尋求 Vafseo 在非透析患者群體中的批准，並繼續朝著我們的目標前進，即在 2025 年下半年啟動 NDD 中的 III 期 VALOR 試驗。

We're planning to meet with the FDA to further discuss the VALOR trial, which will study the use of Vagadusta in treating anemia in CKD patients who are not on dialysis. We'll continue to update you on our progress as appropriate. While the Vafseo launch and initiating valor remain our top priorities, we'll also update you throughout 2025 about our plans to advance our pipeline of HIPH inhibitors and other assets. We are working towards having multiple product candidates enter the clinic this year. Akebia is an incredibly strong position the team has worked very hard to get us here.

我們計劃與 FDA 會面，進一步討論 VALOR 試驗，該試驗將研究 Vagadusta 在治療未接受透析的 CKD 患者貧血的應用。我們將適時繼續向您通報我們的進展。雖然 Vafseo 的推出和啟動勇氣仍然是我們的首要任務，但我們也將在 2025 年向您通報我們推進 HIPH 抑制劑和其他資產管道的計畫。我們正在努力讓多個候選產品今年進入臨床階段。Akebia 的地位非常穩固，團隊付出了很多努力才讓我們達到這個地位。

Now first, Nick is going to give you a detailed view of our launch progress, and then Eric will talk to you about our strong first quarter results and enhanced financial position.

現在，首先，尼克將向您詳細介紹我們的發布進度，然後埃里克將向您介紹我們強勁的第一季業績和增強的財務狀況。

Now let me turn it over to Nick to give you more color on the Vafseo launch.

現在讓我把話題交給尼克，讓他給你詳細介紹一下 Vafseo 的發布。

Thanks, John. Good morning, folks. I am also pleased with the strength of the Vafseo launch and the sales achieved through the first quarter. As we have discussed previously during the launch, we are focusing on breadth, the number of physicians prescribing, and depth, the amount physicians are prescribing. On those efforts, we see multiple indicators of strong demand from the field.

謝謝，約翰。大家早安。我對 Vafseo 的推出以及第一季的銷售表現也感到滿意。正如我們之前在發布會上討論過的，我們關注的是廣度，即開處方的醫生數量，以及深度，即醫生開處方的數量。在這些努力中，我們看到了來自該領域強勁需求的多個指標。

First, we ended the quarter with more than 640 prescribers, which represent a nearly 25% increase compared to the end of February when we last updated you. We are adding to the breadth of prescribers from various dialysis organizations, though still most are ordering for patients at USRC. While prescribers at other dialysis organizations are writing, USRC makes up the vast majority of prescriptions.

首先，在本季結束時，我們的處方員人數超過 640 人，與我們上次更新的 2 月底相比增加了近 25%。我們正在擴大來自各個透析組織的處方範圍，但大多數處方仍為 USRC 的患者開立。雖然其他透析組織的處方員也在開藥，但 USRC 佔了處方的絕大多數。

In order to continue to increase breadth, we will not only need to continue to grow within our current customers, but we must also continue to expand into new small to mid-sized dialysis organizations, many of which have protocols in place or have recently operationalized the protocols.

為了繼續擴大服務範圍，我們不僅需要在現有客戶中繼續發展，還必須繼續擴展到新的中小型透析組織，其中許多組織已經制定了協議或最近已開始實施這些協議。

John noted that we have now generated sales from the top five dialysis organizations who treat approximately 85% of patients. The orders from the top two dialysis organizations were to address patients with medical exceptions. We continue to work with large dialysis organizations and expect one of them to operationalize Vafseo in the third quarter of this year. This will allow us to continue to grow our breadth of prescribers substantially.

約翰指出，我們現在已經從治療約 85% 患者的前五名透析機構獲得了銷售額。兩大透析機構的命令是針對有醫療異常的病人。我們繼續與大型透析組織合作，預計其中一個組織將在今年第三季投入運作 Vafseo。這將使我們能夠繼續大幅擴大我們的處方範圍。

Second, depth of prescribing is tracked by looking at prescriptions per provider. Prescriptions per provider have grown to approximately twelve at the end of March from nearly eight at the end of February. The increase speaks to our focus on depth that I described during our last call. Our team has worked diligently to help prescribers identify appropriate patients and work through the ordering process. Though there is a broad range of utilization within the prescribers, we believe for some physician, it reflects a shift from initial trial to sustained use across a broader number of patients.

其次，透過查看每個提供者的處方來追蹤處方深度。每位醫療服務提供者的處方數量已從 2 月底的近 8 張增加到 3 月底的約 12 張。這一增長體現了我在上次電話會議中所描述的我們對深度的關注。我們的團隊一直努力幫助開藥者確定合適的患者並完成訂購流程。儘管處方人員的使用範圍很廣，但我們認為，對於一些醫生來說，這反映了從初步試驗到更廣泛患者持續使用的轉變。

Once a patient starts therapy, it's important for them to maintain on therapy. We measure this through the refill rate. Refills are coming in as expected. About 1/3 of all prescriptions written in quarter one were refills. Notably, the refill data demonstrate an increase in dose as prescribers titrate towards levels we observed in our clinical trial.

一旦患者開始接受治療，堅持治療就很重要。我們透過補充率來衡量這一點。補充裝正在如預期中進行。第一季開出的所有處方中約有三分之一是續藥。值得注意的是，補充數據顯示，隨著處方醫師逐漸將藥物劑量調整至我們在臨床試驗中觀察到的水平，劑量也會增加。

Lastly, we are closely monitoring purchasing patterns. At the end of the quarter, we have seen channel stocking at about four weeks of inventory, which is about one week higher than earlier in the quarter. As we move further through the launch, we should expect inventory fluctuations as we bring on more customers, and we believe inventory will settle between two to four weeks on hand.

最後，我們正在密切監測購買模式。截至本季末，我們發現通路庫存約為四周，比本季初高出約一週。隨著我們進一步推進產品發布，隨著我們吸引更多客戶，我們應該預期庫存會出現波動，並且我們相信庫存將在兩到四周穩定下來。

For clarity, we estimate Vafseo Q1 sales were composed of about 2/3 demand and 1/3 inventory. Anecdotally, many of our key account managers have commented on the positive reception among prescribers. Though just a small sample size, we are hearing that physicians and anemia managers are commenting on hemoglobin stability, ease of dose and festration, minimal dose adjustments, and efficacy in ESA hyper-responders. We are hopeful that this is an early sign that the health clinic staff will be able to maintain a patient's hemoglobin within the target range and be able to focus on other aspects of a patient's care.

為了清楚起見，我們估計 Vafseo Q1 的銷售額由約 2/3 的需求和 1/3 的庫存組成。有趣的是，我們的許多大客戶經理都對處方者的正面回饋發表了評論。儘管樣本量很小，但我們聽說醫生和貧血管理人員正在評論血紅蛋白穩定性、劑量和潰爛的簡易性、最小劑量調整以及 ESA 高反應者的療效。我們希望這是一個早期跡象，表明醫療診所工作人員能夠將患者的血紅蛋白維持在目標範圍內，並能夠專注於患者護理的其他方面。

We have also heard the disappointment and importantly, willingness to advocate from physicians affiliated with dialysis organizations that have yet to make Vafseo available for prescribing through a broad protocol. Physician advocacy is important as we continue to work closely with dialysis organizations to operationalize protocols. Reimbursement trends remain encouraging, as we previously discussed, we have been initially focused on the access for Medicare fee for service patients within the TDAPA reimbursement system.

我們也聽到了來自透析組織附屬醫生的失望之情，更重要的是，他們願意倡導尚未透過廣泛的協議提供 Vafseo 處方。當我們繼續與透析組織密切合作以實施協議時，醫生的倡議非常重要。報銷趨勢仍然令人鼓舞，正如我們之前所討論的，我們最初關注的是 TDAPA 報銷系統內服務患者獲得醫療保險費用的機會。

We also indicated that we expected Medicare Advantage coverage where dialysis organizations had contracted with Medicare Advantage plans for a TDAPA like or innovation payment. We continue to see reimbursement outside of Medicare fee for service. We believe that this is a signal that even early in the launch, prescribers want to use Vafseo for patients regardless of the health plan the patient is on, and that some Medicare advantage plans are also ready to cover Vafseo. The launch is proceeding as we planned. Demand continues to grow, and we are establishing a strong foundation for Vafseo.

我們還表示，我們預計透析機構將獲得醫療保險優勢計劃的覆蓋，該計劃已與醫療保險優勢計劃簽約，以獲得類似 TDAPA 或創新支付。我們繼續看到醫療保險服務費以外的報銷。我們認為，這是一個信號，表明即使在推出初期，處方人員也希望為患者使用 Vafseo，無論患者採用何種健康計劃，並且一些醫療保險優勢計劃也準備涵蓋 Vafseo。發射正在按照我們的計劃進行。需求持續成長，我們正在為 Vafseo 建立堅實的基礎。

Our team is highly focused on continuing to increase breadth and depth of prescribing at current customers, unlocking new customers, and supporting the largest dialysis organizations in protocol activation.

我們的團隊高度致力於持續增加現有客戶的處方廣度和深度，開拓新客戶，並支援最大的透析組織進行協議啟動。

Let me now turn it over to Eric.

現在讓我把它交給 Eric。

Thanks, Nick. As mentioned, we're very pleased with the initial quarter of sales, which, along with solid Q1 Auryxia sales performance, drove strong Q1 results. I will now provide an overview of those results. Total revenues, which are comprised primarily of net product revenues and also include licensing collaboration revenues, increased to $57.3 million in Q1 of this year as compared to $32.6 million in Q1 of last year.

謝謝，尼克。如上所述，我們對第一季的銷售情況非常滿意，再加上 Auryxia 第一季的穩健銷售業績，推動了第一季業績的強勁成長。我現在將概述這些結果。總收入主要包括淨產品收入，也包括授權合作收入，今年第一季總收入增至 5,730 萬美元，而去年第一季為 3,260 萬美元。

Of these amounts, net product revenues increased to $55.8 million in Q1 of this year as compared to $31 million in Q1 of last year, driven by the introduction of that this quarter, which generated $12 million in net revenues, as well as by an increase in Auryxia net product revenues which were $43.8 million in Q1 of this year as compared to $31 million in Q1 of last year. As a reminder, Auryxia lost IP exclusivity in March, and an authorized generic for Auryxia has now entered the market, though no other generics have been approved nor entered the market at this time. We are pleased with this quarter's strong Auryxia result. Though caution future Auryxia sales levels are challenging to predict due to the uncertainty around the timing of potential additional generic competition.

其中，今年第一季淨產品收入增至 5,580 萬美元，而去年第一季為 3,100 萬美元，這得益於本季度推出的該產品，產生了 1,200 萬美元的淨收入，以及 Auryxia 淨產品收入的增加，今年第一季 Auryxia 淨產品收入為 4,380 萬美元，而去年第一季為 300 萬美元。提醒一下，Auryxia 在 3 月失去了智慧財產權獨佔權，Auryxia 的授權仿製藥現已進入市場，但目前尚未有其他仿製藥獲得批准或進入市場。我們對 Auryxia 本季的強勁業績感到滿意。不過，由於潛在的額外仿製藥競爭時機的不確定性，未來 Auryxia 的銷售水準很難預測。

The costs of goods sold of $7.6 million in Q1 of this year was lower as compared to $11.6 million in Q1 of last year, even with higher sales levels in this year's quarter. A driver of this lower level of costs is that we are no longer recording a $9 million quarterly non-cash amortization charge related to the acquired developed product rights for, which was fully amortized as of the end of last year. Of note, Vafseo sales were derived from pre-launch inventory, which does not include the full cost of manufacturing, as a portion of those inventory-related costs were previously expensed prior to Vafseo's FDA approval.

儘管今年第一季的銷售額較高，但銷售成本為 760 萬美元，低於去年第一季的 1,160 萬美元。成本降低的一個原因是我們不再記錄與收購的開發產品權利相關的 900 萬美元季度非現金攤銷費用，該費用已於去年年底全部攤銷。值得注意的是，Vafseo 的銷售額來自於上市前的庫存，其中不包括製造的全部成本，因為這些庫存相關成本的一部分在 Vafseo 獲得 FDA 批准之前就已經計入費用。

Also, during Q1 of last year, we realized a $3.7 million dollar benefit due to our ability to sell inventory previously written down as excess inventory.

此外，去年第一季度，由於我們能夠出售先前減記為多餘庫存的庫存，我們實現了 370 萬美元的收益。

On the topic of inventory as related to tariffs, I want to highlight that we have at least 12 months of Vafseo inventory on hand in the US and do not expect any meaningful tariff-related impact on Vafseo or Auryxia at this time. We will continue to monitor developments in this area and we're to be ready to react to potential scenarios that could play out.

關於與關稅相關的庫存問題，我想強調的是，我們在美國至少有 12 個月的 Vafseo 庫存，目前我們預計關稅不會對 Vafseo 或 Auryxia 產生任何重大影響。我們將繼續關注該領域的發展，並準備對可能發生的潛在情況做出反應。

R&D expenses of $9.8 million and SG&A expenses of $25.7 million in Q1 of this year were essentially flat as compared to Q1 of last year. Turning to the bottom line, we generated net income of $6.1 million in Q1 of this year as compared to a net loss of $18 million in Q1 of last year. This quarter's net income was driven by the increase in net product revenues, which was partially offset by $5.4 million in interest expense related to the settlement royalty liability in connection with the July 2024 Q4 termination and settlement.

今年第一季的研發費用為 980 萬美元，銷售、一般及行政費用為 2,570 萬美元，與去年第一季相比基本持平。談到底線，我們今年第一季的淨收入為 610 萬美元，而去年第一季的淨虧損為 1,800 萬美元。本季度的淨收入是由淨產品收入的增長推動的，但與 2024 年 7 月第四季度終止和結算相關的和解特許權使用費負債相關的 540 萬美元利息費用部分抵消了這一增長。

We ended Q1 with $113.4 million in cash and cash equivalents. During the quarter, we bolstered our cash position via an underwritten public offering completed in March, which raised over $46 million in net proceeds and importantly also served to expand institutional investor support of Akebia.

我們第一季結束時的現金和現金等價物為 1.134 億美元。在本季度，我們透過 3 月完成的承銷公開發行增強了我們的現金狀況，籌集了超過 4,600 萬美元的淨收益，更重要的是，還擴大了機構投資者對 Akebia 的支持。

We believe we are financed to achieve profitability based on our current operating plan, which includes pursuing label expansion for Vafseo and advancing our other existing programs. In closing, we exited Q1 with strong initial Vafseo launch, solid financial position, and an overall positive business momentum. That said, our work is not done, and we will continue to diligently work to execute on our business plan.

我們相信，根據我們目前的營運計劃，我們有足夠的資金來實現盈利，其中包括擴大 Vafseo 的標籤業務和推進我們現有的其他項目。最後，我們在第一季結束時表現出強勁的 Vafseo 初始發布、穩固的財務狀況和整體積極的業務勢頭。話雖如此，我們的工作尚未完成，我們將繼續努力執行我們的商業計劃。

And with that we welcome.

我們對此表示歡迎。

Thank you. At this time, we will conduct the question and answer session.

謝謝。此時，我們將進行問答環節。

(Operator Instructions)

（操作員指示）

Your first question comes from the line of Roanna Ruiz from Leerink Partners. Your line is now open.

您的第一個問題來自 Leerink Partners 的 Roanna Ruiz。您的線路現已開通。

Hey, morning everyone. So, a couple for me for Vafseo, could you update us about your expected timelines for adding it to protocols and implementing them at the large dialysis organizations since it sounds like most of the growth has been driven by mid and small size ones right now. And when the LDOs do order and use Morvafcio, how do you expect that to increase the prescribing rates or other launch metrics over time?

大家早安。因此，對於 Vafseo 來說，您能否向我們介紹將其添加到協議中並在大型透析組織中實施的預期時間表，因為聽起來目前大部分增長都是由中型和小型透析組織推動的。當 LDO 確實訂購並使用 Morvafcio 時，您預計它會如何隨著時間的推移提高處方率或其他發布指標？

Great, Roanna, thanks so much for the question. So, the timelines for the LDOs, and I'm going to ask Nick to give more detail, but in the first, as I mentioned, they're starting a large pilot to operationalize their protocol. The protocols written but they need to ensure that, because they're so large that they can operationalize it across the across the system without issues and patients can continue to get drugged. Remember, they're going to be shipping drugs to patients' homes, so it's a different mechanism for treating anemia.

太好了，Roanna，非常感謝你提出這個問題。因此，LDO 的時間表，我將請 Nick 提供更多細節，但首先，正如我所提到的，他們正在啟動一個大型試點項目來實施他們的協議。協議已經寫好，但他們需要確保，由於協議規模很大，他們可以在整個系統中順利運行，並且患者可以繼續用藥。請記住，他們會將藥物運送到患者家中，因此這是一種治療貧血的不同機制。

So let, Nick talk more about that pilot because we're really excited that that's moving forward.

那麼，讓尼克更多地談論那個試點項目，因為我們真的很高興它正在向前推進。

Yeah, so this pilot is a large operational pilot, and again, to reiterate, this is not seeking efficacy data. It's to make sure patients can get their initial fill. The systems work to make sure they get formulary access. They can get refill data, and typically these pilots can be between 50 and 200 sites. You talk about a pilot of 200 sites that that's bigger than most dialysis organizations.

是的，這個試點計畫是一個大型營運試點項目，再次重申，這並不是為了尋求功效數據。這是為了確保患者能夠得到初步治療。這些系統確保他們能夠獲得處方集。他們可以獲得補充數據，通常這些試點可以在 50 到 200 個站點之間。您談到了 200 個站點的試點，其規模比大多數透析組織都要大。

We have a number of physicians that have raised their hand to be on that pilot. And we've heard back that many of our KMEs who we interact with have already heard that they'll be part of that pilot. So, this thing is the trainers roll it on this thing. And typically how these pilot work is that they roll it out through training their staff and so they'll probably spend a month or so training their staff on what to expect, as John mentioned, it's a little bit different way of treating anemia and so we want to make sure the staff is well trained and then they'll enroll the sites.

有許多醫生已表示願意參加此試點計畫。我們收到的回覆是，與我們互動的許多 KME 已經獲悉他們將參與該試點計畫。所以，這個東西是訓練員在這個東西上滾動的。這些試點計畫的典型工作方式是，透過培訓員工來推廣，因此他們可能會花一個月左右的時間培訓員工了解預期情況，正如約翰提到的，這是一種治療貧血的不同方法，因此我們要確保員工訓練有素，然後他們才會在站點進行登記。

They'll spend one to three months probably in the pilot, more like probably two to three months than one, because they want to make patients make sure that patients get a refill and once, they check the box that all the systems are working and everything's connected, they're going to roll it out more broadly. And so, when we think about that pilot in third quarter, broader roll out in fourth quarter.

他們可能會花一到三個月的時間進行試點，更可能是兩到三個月而不是一個月，因為他們想讓患者確保他們能得到補充藥物，一旦他們確認所有系統都正常運行並且一切都已連接，他們就會更廣泛地推廣它。因此，當我們考慮在第三季度進行試點時，將在第四季度進行更廣泛的推廣。

Right, that's and as we said, I mean not really.

是的，正如我們所說，我的意思並非如此。

Kind of doubles the number of patients who can access the product once that one LDO goes and when you think about how physicians will prescribe, I mean the folks at US Renal, the physicians who are writing now, what was the number next something over 50% also have patients at one of the large providers. So, you've already got.

一旦一個 LDO 失效，能夠使用該產品的患者數量就會增加一倍，當您考慮醫生如何開處方時，我的意思是美國腎臟病中心的人們，現在正在開處方的醫生，接下來的數字是多少？超過 50% 的人也在一家大型醫療供應商那裡有病患。所以，你已經得到了。

And physicians who are used to writing the product and want to write the product, so we think, and frankly, a lot of those are the ones who are raising their hands to be a part of the pilot, they'll start increasing their prescribing quickly.

我們認為，那些習慣於編寫產品並希望編寫產品的醫生，坦白說，其中許多人舉手參加試點，他們會開始迅速增加處方量。

Now the second LDL was earlier in their process. We are working with them to share data, etc. As I said in my remarks, I'm very encouraged that they've ordered product and they are allowing physicians on an exception basis to get the product, right? That's why we wanted to make sure we had that contract in place with them. But we clearly see that they're going to take longer before you get broad use from them. But of course, we're doing all that we can to move that as quickly as we can.

現在，第二個 LDL 已處於其治療過程的早期階段。我們正在與他們合作共享數據等。正如我在演講中所說，我很高興他們已經訂購了產品，並且允許醫生例外獲得產品，對嗎？這就是為什麼我們要確保與他們簽訂合約。但我們清楚地看到，它們還需要更長的時間才能得到廣泛的應用。但當然，我們正在盡一切努力盡快實現這一目標。

But the idea that if you think about Q2 will clearly still be driven by the small and medium providers. 150,000 patients at the small and medium providers. Lots of room to grow when you think about the number of patients we have on today. At the end of the end of the first quarter, something just over 5,000 patients, right? I think that in the context of 150,000 available patients, there's lots of room to grow at the small and medium providers, but we're incredibly excited to get the large provider, the first large provider up and running, because I think that's the function that comes into growth.

但是，如果你考慮第二季度，這個想法顯然仍將由中小型供應商推動。中小型供應商有 15 萬名患者。當你考慮到我們今天所接待的患者數量時，你會發現還有很大的成長空間。第一季末的時候，病人數量大概在 5,000 多人吧？我認為，在擁有 15 萬名可用患者的背景下，中小型供應商還有很大的成長空間，但我們非常高興大型供應商、第一家大型供應商能夠開始運營，因為我認為這是實現成長的功能。

Got it. It's really helpful. And quick follow up for me. It sounds also like the average prescriptions for Vafseo is increasing at a nice rate. How do you expect that to keep going or ramping into two based on some of the metrics you saw exiting first quarter?

知道了。這真的很有幫助。並快速跟進我的情況。聽起來 Vafseo 的平均處方量也以良好的速度成長。根據您在第一季看到的一些指標，您預計這一數字將如何繼續成長或成長至兩季？

Well, clearly, some of the increase in breath is refits, right? I mean, you're so the patients are staying on, and that's a really good thing.

嗯，顯然，一些氣息的增加是改裝的，對吧？我的意思是，病人會繼續留下來，這真是一件好事。

But I'll let Nick comment.

但我會讓尼克發表評論。

Yeah, I talked in my comments about we're seeing some physicians moving towards we'll call it standard utilization, where they're using in a broad set of patients. That being said, the range of utilization is still really broad. We have a number of prescribers that are still only in the early trial stage with one or two prescriptions for patients and so certainly there's a ton of growth still within the prescribing base as those physicians become comfortable with Vafseo and roll it out to broader patients. And then we have all the physicians who have yet to prescribe at some of the medium and smaller dialysis organizations that are poised to Protocols are in place. They're operationalizing those protocols, and certainly we expect the prescriber base to continue to expand and thus adding to the number of prescriptions per provider.

是的，我在評論中談到，我們看到一些醫生正在轉向我們稱之為標準利用的方法，他們在廣泛的患者群體中使用它。話雖如此，其利用範圍仍然非常廣泛。我們有許多開處方的醫生仍處於早期試驗階段，為患者開出一到兩張處方，因此，隨著這些醫生對 Vafseo 感到滿意並將其推廣到更廣泛的患者，處方基礎肯定會有很大的增長。然後，我們讓所有尚未在一些中型和小型透析機構開處方的醫生都準備好制定協議。他們正在實施這些協議，當然我們預計處方者基礎將繼續擴大，從而增加每個提供者的處方數量。

Yeah, Roanna, as I mean, the interesting thing about dialysis is, you normally think about a launch, and you have your early adopters who can start writing the drug and then you kind of march through. And what you have to do in dialysis is you add that layer of access at the dialysis providers. So, you got folks who are early adopters at a, DaVita Fresenius who just can't access the product yet.

是的，羅安娜，我的意思是，透析的有趣之處在於，你通常會考慮推出一種藥物，然後你有早期採用者可以開始編寫藥物，然後你就可以繼續前進。在透析中你需要做的是在透析提供者處添加該訪問層。所以，您會看到 DaVita Fresenius 的早期採用者還無法使用該產品。

Those are the people that we're using truly to advocate for that broadened access and to accelerate that, and I think that's paid off in, the speed with which the first LDO is moving towards their large scale pilot, but it does create that level of complexity.

這些人正是我們真正倡導擴大准入並加速這一進程的人，我認為，這已經得到了回報，第一個 LDO 正在快速走向大規模試點，但這確實帶來了一定程度的複雜性。

That you've got to go through that and as Nick said, I mean most of our prescriptions are coming from US renal, but we've got orders from the other mid-sized providers, but they're just at the early stages. So we're really excited about what they can yield in Q2 and Q3 and beyond.

你必須經歷這個過程，正如尼克所說，我的意思是我們的大部分處方都來自美國腎臟，但我們也收到了其他中型供應商的訂單，但他們還處於早期階段。因此，我們對他們在第二季、第三季及以後的業績感到非常興奮。

Got it, thanks very much.

明白了，非常感謝。

Thank you.

謝謝。

Thank you, and your next question comes from the line of Julian Harrison from BTIG. Your line is now open.

謝謝，您的下一個問題來自 BTIG 的 Julian Harrison。您的線路現已開通。

Hi, congrats on all the progress. This is Rayan for Julian and thanks for taking our question. Just one for us, have there been, has there been any material shift from Auryxia prescriptions to the currently authorized generic? Just curious how we should be thinking about generic penetration going forward.

嗨，恭喜你取得所有進展。我是朱利安的雷揚，感謝您回答我們的問題。只問我們一個問題，從 Auryxia 處方到目前授權的仿製藥，有沒有什麼實質的轉變？只是好奇我們應該如何看待未來的通用滲透。

Thanks so much for the question. So, as that the authorized generic only entered the market post March 20th, right? So in the quarter it was very little, and we know exactly how much product went into the market and how much, that the AG will receive over the course of the year. So, we know, certainly the first quarter that's minimal and, won't be a large percentage of the business, even in Q2, the real question will be.

非常感謝您的提問。那麼，授權仿製藥是在 3 月 20 日之後才進入市場的，對嗎？因此，本季的產品數量非常少，我們確切地知道有多少產品進入了市場，以及 AG 全年將收到多少產品。因此，我們知道，第一季的銷售額肯定很小，而且佔業務的比重也不會很大，即使在第二季度，真正的問題也是如此。

The next, the first file are getting approved, and we've always been, as you said in the past, been very cautious, as you know the way the dynamic works, you have the AG is out, the first filer has six months of exclusivity as well, and during that time, we think we can maintain a significant amount of revenue. We have the right to match prices within our contracts because having URIC in the bundle has changed things. But without a, an ANDA approval from the FDA, there's a great opportunity for us. We just have no idea how long that's going to last, but every day that it does, here we are on May 8th.

接下來，第一份文件正在獲得批准，正如你過去所說的那樣，我們一直非常謹慎，因為你知道動態的工作方式，你有 AG，第一個文件提交者也有六個月的獨家經營權，在此期間，我們認為我們可以保持大量的收入。我們有權在合約中匹配價格，因為捆綁包中的 URIC 改變了一切。但如果沒有 FDA 的 ANDA 批准，對我們來說就有很大的機會。我們只是不知道這種情況會持續多久，但每過一天，我們就到了 5 月 8 日。

And again, March 20th was the first day that, our contracts suggested ANDA filer, a generic, could answer the market, and no one's been approved yet. So, we're enjoying that situation and we have the product and we'll be able to service the market for as long as that lasts.

再說一次，3 月 20 日是我們的合約建議 ANDA 申請人（一種仿製藥）可以滿足市場的第一天，但​​目前還沒有人獲得批准。所以，我們很享受這種情況，我們有產品，只要這種情況持續，我們就能為市場提供服務。

Which I just can't give you guidance on when a generic might be approved.

我只是無法指導您何時可以批准仿製藥。

We're hoping it takes a while.

我們希望這需要一段時間。

Got it. Thank you.

知道了。謝謝。

Thank you. Please stand by for your next question.

謝謝。請等待回答您的下一個問題。

And our next question is from the line of Roger Song from Jefferies. Your line is open.

我們的下一個問題來自 Jefferies 的 Roger Song。您的線路已開通。

Excellent, thanks for taking the question, and for the update. Just a question related to the net price, given right now, you're focusing on the mid to, small to mid pro provider and then how this will change over time when you get, more patient from the large, deal.

非常好，感謝您提出這個問題並提供最新消息。這只是與淨價相關的一個問題，鑑於目前的情況，您關注的是中型到小型到中型專業供應商，那麼當您從大型交易中獲得更多耐心時，這種情況將如何隨著時間的推移而變化。

Thank you.

謝謝。

Yeah, no thanks, Roger, for the question. It's good to have you on the call. So, as it comes to net price, this is a very competitive environment that we are selling Vafseo in, so we're, obviously incredibly careful about, what we talk about, a couple of things just to remind you, the way the contracts are structured, it's an off invoice and then and then a rebate, but of course the net that Eric described includes that, the discount for that rebate, although it won't be paid until sometime in the future. But you know what we've also said is over time, we expect the net price per patient to decrease as volumes increase, but you really see as you think about the dynamic of the, kind of mid-size providers coming in, you just see lumpiness in the net price over some period of time and I will say you have that our net revenue, you have our number of prescribers, prescription per prescriber. I think you can get you can get pretty close to our net price per prescription in with the data that we've given you.

是的，羅傑，謝謝你的提問。很高興您能接聽電話。因此，就淨價而言，我們銷售 Vafseo 的環境競爭非常激烈，因此，我們顯然非常謹慎，我們談論的內容，有幾件事需要提醒您，合約的結構方式是先從發票中扣除，然後是回扣，但當然，Eric 描述的淨價包括了回扣的折扣，儘管它要到未來的某個時候才會支付。但你知道我們也說過，隨著時間的推移，我們預計每位患者的淨價格會隨著數量的增加而下降，但當你考慮中型供應商的動態時，你會看到淨價格在一段時間內出現波動，我會說你有我們的淨收入，你有我們的開處方者數量，每個開處方者的處方數。我認為，透過我們提供的數據，您可以獲得非常接近每張處方的淨價。

Great, that's helpful. And then I think you provided the new script versus repeat script as the 1/3 2/3, 2/3 to 1/3, and then how should we think about over time this will change, particularly when you have the launch, basically you have the broader roll out for the for the prescription.

太好了，很有幫助。然後我認為您提供了新的腳本與重複腳本作為 1/3 2/3、2/3 到 1/3，然後我們應該如何考慮隨著時間的推移這將發生變化，特別是當您推出時，基本上您對處方進行了更廣泛的推廣。

Thank you.

謝謝。

Great question, Nick. You want to take that one?

很好的問題，尼克。你想拿那個嗎？

Yeah, early in the launch, obviously most of our prescriptions are new patients as those are coming on, and those patients over time will continue to get refill rates. I wish compliance and dialysis were a little bit better, but you'll have an average compliance rate through market research at about kind of 65% range so you can expect those refills will grow as our percentage of total prescriptions, but again lumpiness will exist, right? So that lumpiness as new providers come on and for example an LDO in the second half, all those could be new prescribers for new patients. And so, when we think about that lumpiness will play out in the second half as well. The important thing about the refill is to get the dose right? When we think about dose titration in our clinical trials, we saw that the starting dose was obviously 300 mg and that the average dose once folks were fully titrated was about 50% above that number. So, when you think about refills, it's really important to pull in that dose increases, and we're seeing that in those prescriptions that are refills.

是的，在推出初期，顯然我們的大多數處方都是新患者，隨著時間的推移，這些患者將繼續獲得續藥率。我希望依從性和透析效果能好一點，但透過市場調查，平均依從率大約在 65% 左右，因此您可以預期這些續藥量佔總處方量的百分比會增長，但還是會存在不均等性，對嗎？因此，隨著新供應商的出現以及下半年的 LDO 等出現，所有這些都可能成為新患者的新處方者。因此，我們認為這種不平衡性在下半年也會出現。補充藥物最重要的是劑量要正確？當我們考慮臨床試驗中的劑量滴定時，我們發現起始劑量顯然為 300 毫克，而一旦人們完全滴定，平均劑量將比該數字高出約 50%。因此，當您考慮補充藥物時，引入劑量增加非常重要，我們在補充的處方中看到了這一點。

Yeah, that's a very important point. I mean that is going to be a little bit of a moving target as patients come on, but that ultimately most prescriptions are going to be closer to, I think the average was 430 mg in in innovate.

是的，這是非常重要的一點。我的意思是，隨著患者的增加，這將是一個有點移動的目標，但最終大多數處方將更接近，我認為創新的平均劑量是 430 毫克。

So that's probably where we'll land is somewhere I think in real life it's usually a little bit lower than, but when you think about that from a revenue perspective, you do have to factor that in, so we've talked about that $15,500 WACC, that's at 300 mg. So, once you start adding that increase in dose, thinking about that ratio between new and existing. You're going to see that whack price, that gross price increase to some extent. And I think as physicians become more comfortable with where patients are going to land and they understand the focus data for three times weekly dosing and the modified data, they may even be starting more patients at higher doses. So, you know we'll keep updating you on that, but that will take some time for it to develop.

所以這可能是我們最終的目標，我認為在現實生活中它通常會低一點，但是當你從收入角度考慮這個問題時，你必須考慮到這一點，所以我們討論了 15,500 美元的 WACC，即 300 毫克。因此，一旦開始增加劑量，請考慮新劑量和現有劑量之間的比例。你會看到價格暴漲，總價格會在某種程度上上漲。我認為，隨著醫生對患者的治療方案越來越熟悉，並且他們了解每週三次給藥的重點數據和修改後的數據，他們甚至可能會開始為更多患者提供更高劑量的治療。所以，您知道我們會繼續向您通報最新情況，但這需要一些時間來發展。

Wait, maybe just one last one quick one. In terms of the NDD trial, given all the changes happening on the background at the FDA side, how confident you are, given the trial design you have been guiding how confident you can start the trial second half with the design you proposed.

等一下，也許只剩下最後一個快速的了。就 NDD 試驗而言，考慮到 FDA 方面後台發生的所有變化，考慮到您一直指導的試驗設計，您有多大信心按照您提出的設計開始試驗的後半部分。

Thank you.

謝謝。

Yeah, it's a great question. I mean, there are clearly, things happening at the FDA. I mean, remember, we are regulated by CER, not CE. So, you know we've had a change in the division director for non-malignant hematology that happened, some, a few months ago. We know the division director who's there now, the interim, we think she's great.

是的，這是一個很好的問題。我的意思是，FDA 顯然正在發生一些事情。我的意思是，請記住，我們受 CER 監管，而不是 CE。您知道，幾個月前，我們的非惡性血液學部門主任發生了變動。我們認識現在的臨時部門主管，我們認為她很棒。

We've interacted with her on a number of occasions and found her very pragmatic. We haven't seen any other changes at this point to our review team, so we don't have any reason to believe that we can't do that. I mean, we are doing a lot of work to initiate this trial, I'll call it at risk, we're because we want to be ready to start dosing patients before the end of the year. Again, a lot of the comments that we're expecting in the discussion will be around the statistical analysis plan and how we're handling that versus, some of the more operational aspects of the trial. So, we think we can do that with very little risk. So, we still feel we're on target if that changes obviously, as appropriate, we're going to update you, but we're still working towards that end of year timeline.

我們曾多次與她互動，發現她非常務實。目前我們還沒有看到我們的審核團隊有任何其他變化，所以我們沒有理由相信我們不能做到這一點。我的意思是，我們正在做大量工作來啟動這項試驗，我稱之為有風險的，因為我們希望在年底之前準備好開始給患者用藥。再次，我們預計討論中的許多評論將圍繞統計分析計劃以及我們如何處理該計劃以及試驗的一些更具操作性的方面。因此，我們認為我們可以以很小的風險做到這一點。因此，我們仍然認為，如果情況發生明顯變化，我們會在適當的時候向您通報最新情況，但我們仍在努力實現年底的時間表。

Thanks for all the comments.

感謝大家的評論。

Thank you.

謝謝。

Thanks Roger.

謝謝羅傑。

(Operator Instructions)

（操作員指示）

Your next question is from the line of Allison Bratzel from Piper Sandler. Your line is now open.

您的下一個問題來自 Piper Sandler 的 Allison Bratzel。您的線路現已開通。

Hey, good morning, thanks for taking the questions. A couple from me.

嘿，早上好，感謝您回答問題。這是我的一些。

First, just, bigger picture, could you talk about what's driving demand so far for Bastio, the clinical profile versus, economic incentives, created by TDAPA. And then second, just a question on vast reimbursement trends, any detail on what you're seeing in terms of coverage at, Medicare Advantage plans, are you seeing innovation payments or just what does that look like? Any color or detail there would be helpful.

首先，從更大的角度來看，您能否談談迄今為止推動 Bastio 需求的因素，即臨床概況與 TDAPA 創造的經濟激勵措施。第二，關於廣泛的報銷趨勢的問題，您能詳細說明一下醫療保險優勢計劃的覆蓋範圍嗎？您是否看到了創新支付，或者它是什麼樣子的？任何顏色或細節都會有幫助。

Thank you.

謝謝。

I'm going to let Nich answer most, but from the demand perspective, I think just a broad statement is, we're seeing most of the sales today at US Renal and whether it's at US renal or the other dialysis providers, it's fundamentally driven by a belief in HIF, the opportunities that Vafseo, a HIF product can give to patients. The economic side is enabling, right? It allows the access. It's great when the business side of the dialysis provider is happy to see the product be used, but it's being driven, someone like Jeff Block, who's the principal investigator on the voice trial, and senior person at US Renal on the medical side. I mean, he's talking to Everyone, every physician, because he's a believer, right? And you know that kind of advocacy, we're seeing that at other dialysis providers, the smaller providers as well, but I probably answered too of it for Nick that much more to add there. But I, it is, if they don't believe in the clinical advantages, the economic doesn't hold. It might help you for a couple of years, right? But we're in this to make the standard of care, and they have to believe in the clinical benefit.

我會讓 Nich 來回答大部分問題，但從需求角度來看，我認為一個廣泛的說法是，我們今天看到 US Renal 的大部分銷售，無論是 US Renal 還是其他透析提供商，它的根本原因是對 HIF 的信念，以及 HIF 產品 V​​afseo 可以為患者帶來的機會。經濟方面是有利的，對吧？它允許訪問。當透析提供者的業務部門樂意看到產品被使用時，這很好，但它是由像 Jeff Block 這樣的人推動的，他是語音試驗的首席研究員，也是美國腎臟病學中心醫療方面的高級人員。我的意思是，他正在與每個人、每一位醫生交談，因為他是個信徒，對嗎？您知道，我們在其他透析提供者、規模較小的提供者那裡也看到了這種倡導，但我可能也為尼克回答了這個問題，還有很多要補充。但我認為，如果他們不相信臨床優勢，經濟效益就不大。它可能會幫助你幾年，對嗎？但我們這樣做是為了建立護理標準，他們必須相信其臨床益處。

Yeah, and I can always talk more. Don't worry about that.

是的，我可以講更多。別擔心。

Really, I went through kind of the anecdote, anecdotal feedback we're hearing from physicians at the end, to summarize that, they're finding value in the product, right? And you can see that in a couple different ways. One, if they didn't find value, patients might be one and done, right? They get a bad experience, they move them off of therapy, you wouldn't see a refill. Refills are tracking exactly as we thought they would. So that's one indication of the clinical profile. Two, they're continuing to broader into other patients. If they weren't seeing value in their initial patients they put on, they wouldn't have expanded their prescribing. And so that initial value a little still early in the launch, but it gives us that confidence that folks are seeing the clinical value, and they'll broaden their use. Course to TDAPA, nobody does anything if they lose money on it, and so there is an economic value there as well, and so that that's underpinning it, but without the clinical foundation, the economics doesn't matter if the product doesn't work.

真的，我最後回顧了醫生給的軼事、軼事回饋，總結一下，他們發現了產品的價值，對嗎？您可以透過幾種不同的方式來看到這一點。首先，如果他們沒有發現價值，患者可能就完了，對嗎？他們獲得了不好的體驗，因此他們停止了治療，你不會看到他們再次接受治療。補充情況正如我們想像的那樣。這是臨床特徵的一個指標。二是他們正在繼續擴大治療範圍，以治療其他患者。如果他們沒有看到最初接待的病人的價值，他們就不會擴大處方。因此，初始值在發佈時仍處於早期階段，但它讓我們有信心，人們看到了臨床價值，並且他們會擴大其用途。當然，對於 TDAPA 來說，如果虧錢了，沒人會做什麼，所以它也有經濟價值，這是它的基礎，但如果沒有臨床基礎，如果產品不起作用，經濟價值就無關緊要。

I mean for a short period of time, but it's not sustainable and that's not what we're seeing here.

我的意思是，在短時間內，但它是不可持續的，而這不是我們在這裡看到的。

The second part of your question was reimbursement. We've seen a number of Medicare Advantage plans frankly, there's been broad trial across a number of health plans. So, you see folks when they want to put a patient on. They'll do a trial balloon prescription to make sure it gets covered and reimbursed, and then they'll go broader. There are a number of Medicare Advantage plans that are seeing that broadening of prescribing. In other words, they're covering it.

你問題的第二部分是報銷。坦白說，我們已經看到了許多醫療保險優勢計劃，許多健康計劃都進行了廣泛的試驗。所以，當人們想要安置病人時，你就會看到他們。他們會進行試驗性處方，以確保其能夠被覆蓋和報銷，然後他們會擴大範圍。許多醫療保險優勢計劃都正在擴大處方範圍。換句話說，他們正在掩蓋它。

The dialysis organization has seen that they're covering and they're expanding. And so right now we're seeing roughly an 80/20 between fee for service and other plans. And so, as that evolves over time, we expect it to expand obviously. Also, the larger dialysis organizations have more negotiating leverage with the Medicare Advantage plans. So, as they begin their pilot in the second half of the year and then fully operationalize in the fourth quarter, that may shift favorably towards the end of the year.

透析組織已經看到他們正在覆蓋並且正在擴張。因此，目前我們看到服務費和其他計劃的費用約為 80/20。因此，隨著時間的推移，我們預計它會明顯擴大。此外，規模較大的透析機構在醫療保險優勢計劃的談判中擁有更大的籌碼。因此，隨著他們在下半年開始試點並在第四季度全面投入運營，情況可能會在年底出現有利轉變。

And to be clear, that that 80/20 split is better than what we had planned or expected. So, we're encouraged by that. I think that some of it is early trial balloon kind of prescriptions, but we haven't heard of pushback yet. So that's encouraging.

需要明確的是，80/20 的比例比我們計劃或預期的要好。因此，我們對此感到鼓舞。我認為其中一些是早期的試驗性措施，但我們還沒有聽說有任何阻力。這令人鼓舞。

Please stand by for your next question.

請等待回答您的下一個問題。

The next question is from Les Selowski from Truist Securities. Your line is open.

下一個問題來自 Truist Securities 的 Les Selowski。您的線路已開通。

Good morning. Thank you for taking my questions and congrats on the progress. Just first on the inventory stocking trends, perhaps maybe just comment on that. I know you put out there's potential week out there. But as far as the LDOs come on, do you expect the bolus for the inventory stocking to increase when they first on board and then maybe just provide an over, I guess a highlighted overview of the market landscape for the label expansion opportunities.

早安.感謝您回答我的問題並祝賀您的進展。首先談談庫存趨勢，也許只是對此進行評論。我知道您已經指出了那裡的潛在前景。但是就 LDO 的出現而言，您是否預計當它們首次投入使用時，庫存儲備的推力會增加，然後可能只是提供一個概覽，我想這是一個突出的標籤擴展機會的市場格局概述。

Thank you.

謝謝。

Nick, you want to? Yeah.

尼克，你想嗎？是的。

So, when we think of inventory, we talked about kind of a week higher at the end of the quarter versus when we were talking to you guys back in February. Still, four weeks of inventory is within the normal range of two to four weeks, USRC continues to grow the patient population, so four weeks on a forward-looking where there's growth expected in that next quarter isn't unusual for the product.

因此，當我們考慮庫存時，我們談到本季末的庫存量比二月份我們與你們交談時高出一周。儘管如此，四周的庫存量仍在兩到四周的正常範圍內，USRC 繼續增加患者數量，因此從前瞻性來看，預計下個季度該產品的庫存量將出現四周增長，這並不罕見。

We felt it was important to kind of highlight it as we did obviously. A beat the original guidance that we proposed, but we wanted to give you some flavor there still all within kind of normal ranges.

我們認為強調這一點很重要，我們顯然也這麼做了。這超出了我們最初的指導，但我們想給你一些提示，一切仍在正常範圍內。

When we think about as futures come on, what will happen, and let's just use the LDO that's going to start their large pilot is they'll stock for the pilot, and that pilot isn't broad utilization, but as they see that demand and see how physicians want to utilize the product, that'll give them a good insights to what that stock level needs. Be when they broaden it out.

當我們考慮期貨的到來時，會發生什麼，讓我們只使用將要啟動其大型試點的 LDO，他們將為試點儲備庫存，並且該試點並沒有廣泛利用，但是當他們看到需求並看到醫生希望如何利用該產品時，這將使他們對庫存水平的需求有很好的了解。當他們將其擴大時。

So, I don't expect it to be giant stocking and then kind of waiting around to see if the demand comes. I think they'll put some stock in to make sure they have the appropriate level. Then they'll see some demand and then they'll be able to gauge so they can kind of range accurately project the range between two and four weeks of usage. Now that being said, the distribution network for these LDOs is efficient. We spent a lot of time working on the distribution network in quarter four to allow for prescribed prescriptions to get to the patient's home with some efficiency, and we've seen that play out throughout the late part of Q1 that these prescriptions should be able to reach the patient's homes quickly and we can restock them very quickly. So, we don't anticipate even if they carry minimal inventory or under call the inventory to have any issues at all.

因此，我不希望出現大規模囤貨，然後等待需求到來的情況。我認為他們會投入一些資金以確保他們擁有適當的水平。然後他們會看到一些需求，然後他們就能進行衡量，這樣他們就能準確地預測出兩到四周的使用範圍。話雖如此，這些 LDO 的分銷網絡是高效的。我們在第四季度投入了大量時間改進分銷網絡，以便將處方藥高效地送到患者家中，並且我們在第一季後期看到，這些處方藥應該能夠快速送達患者家中，而且我們能夠非常快速地補充庫存。因此，我們預計即使他們庫存很少或庫存不足，也不會有任何問題。

Right? I mean, I think.

正確的？我是說，我認為。

I think focusing on, the prescriptions and the prescriber demand gives you that underlying sense of the demand for the product and the excitement about the product. Inventory is going to follow demand in a in a really tight way. It's not like we're shipping, thousands of bottles to retail pharmacies and you don't know what happens to them. You know exactly what's happening with all of these here.

我認為關注處方和處方者的需求可以讓您從根本上了解對產品的需求以及對產品的興奮感。庫存將以非常緊密的方式跟隨需求。這不像我們運送數千瓶藥物到零售藥局，而你不知道它們會發生什麼。您確切地知道這裡發生的一切。

Thanks, Nick. So, your other question was around label expansion and NDD, and I appreciate the opportunity to reiterate the excitement about that market for us and our desire, and such as our desire to get to that market. I mean, again, I say it every time, I think every time I'm out in the field meeting physicians, universally, they will tell me that they want to use this product in their non-dialysis patient population.

謝謝，尼克。所以，您的另一個問題是關於標籤擴展和 NDD，我很高興有機會重申我們對該市場的興奮和我們的願望，例如我們進入該市場的願望。我的意思是，我每次都這麼說，我想每次我在實地會見醫生時，他們普遍都會告訴我，他們希望在非透析患者群體中使用這種產品。

So, the demand is there that's an important and a wonderful place to start, and the market is there as well. So, the patient population, if you just look at stage four and stage five, non-dialysis patients who are anemic, it's roughly the same size as the dialysis market. It's about 550,000 patients. These are all patients who have, hemoglobin below ten who are anemic or are being treated with an ESA today, which is a small percentage.

所以，需求就在那裡，這是一個重要且極好的起點，市場也在那裡。因此，如果您只看第四階段和第五階段、患有貧血的非透析患者，其患者群體的規模大致與透析市場的規模相同。大約有55萬名患者。這些都是血紅蛋白低於 10 的患者，患有貧血或正在接受 ESA 治療，這只佔很小的比例。

You know what's important for us too from a business standpoint is recall, we have this TDAPA period where you know we have a higher price in the market, even if as that price declines as our volume grows, it's still higher than the average ESA price for dialysis.

您知道，從商業角度來看，對我們來說重要的是回想一下，我們有這個 TDAPA 時期，您知道我們在市場上有更高的價格，即使隨著我們銷售的成長價格下降，它仍然高於透析的平均 ESA 價格。

We have said in the past we do expect our average price post TDAPA to mirror that of the ESA, which is about $2500 per patient per year. Remember, that's a billion dollars dollar market in dialysis, so it's still a very substantive market that we can be very successful in.

我們過去曾說過，我們確實希望 TDAPA 之後的平均價格與 ESA 的價格相同，即每位患者每年約為 2500 美元。請記住，透析市場規模達十億美元，因此這仍然是一個非常實質的市場，我們可以在其中取得巨大成功。

You don't have that same kind of limitation in the non-dialysis market. It's more traditional market, 50% commercial payers, 50% government, Part D and Medicaid. And recall our average price our whack at 15,500 would be the starting price for non-dialysis as well, but the average dose there is a little lower than dialysis, about 400 mg from our PROTECT study, but that would be something around $20,000 on a WAC basis. You take, a discount, a kind of normal gross to net discount, a discount for compliance, you're still north of $10,000 per patient per year, which is 4X the price that you'd see in dialysis. So, that half a million patient population times 10,000 gives you the sense of how significant from a financial standpoint that non-dialysis market is. And again, we're the only oral product looking to bring a product into that space. So, it's a wonderful market opportunity for us.

在非透析市場中，並沒有同樣的限制。這是更傳統的市場，50％由商業付款人組成，50％由政府、D 部分和醫療補助組成。回想一下我們的平均價格，15,500 美元也是非透析的起始價格，但那裡的平均劑量比透析略低，根據我們的 PROTECT 研究約為 400 毫克，但按 WAC 計算，這大約是 20,000 美元。即使你採取折扣，一種正常的總額到淨額的折扣，一種合規折扣，你仍然需要花費每年每位患者 10,000 美元以上，這是透析價格的 4 倍。因此，將 50 萬名患者數量乘以 10,000，您就能從財務角度了解非透析市場有多重要。再說一次，我們是唯一一家希望將產品帶入該領域的口服產品公司。所以，這對我們來說是一個絕佳的市場機會。

Very helpful, thank you.

非常有幫助，謝謝。

But thanks for joining the call.

但感謝您加入電話會議。

I'm showing no further questions at this time. I would not like to turn it back to Mr. John Butler for closing remarks.

我目前沒有其他問題。我不想把最後發言交還給約翰·巴特勒先生。

Thank you so much, operator, and thanks everyone for your questions and your time this morning. Hopefully we effectively conveyed our enthusiasm about the progress of the Vafseo launch. We are absolutely striving to make Vafseo's standard of care to treat anemia due to CKD and to improve treatment alternatives for CKD patients. We look forward to updating on our progress in August on our Q2 call, and hopefully we'll see many of you during our investor meetings in the coming months.

非常感謝您，接線員，也感謝大家今天早上的提問和時間。希望我們能夠有效地傳達我們對 Vafseo 發布進度的熱情。我們絕對致力於使 Vafseo 成為治療 CKD 貧血的標準，並改善 CKD 患者的治療方案。我們期待在 8 月的第二季電話會議上更新我們的進展，並希望在未來幾個月的投資者會議上見到你們。

Thank you very much. Have a great day.

非常感謝。祝你有美好的一天。

Thank you for your participation in today's conference. (Operator Instructions)

感謝大家參加今天的會議。（操作員指示）

Goodbye.

再見。