Akebia Therapeutics Inc (AKBA) 2024 Q3 法說會逐字稿

Good day. And thank you for standing by. Welcome to the Akebia's third quarter, 2024 financial results conference call at this time. (Operator Instructions)

再會。感謝您的支持。歡迎參加 Akebia 2024 年第三季財務業績電話會議。（操作員指令）

now I'd like to hand the conference over to your speaker today. Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

現在我想把會議交給今天的發言人。投資者關係高級總監 Mercedes Carrasco。請繼續。

Thank you and welcome to Akebia's third quarter, 2024 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 7th, detailing our third quarter financial results. And that release is available on the investor section of our website for your convenience.

感謝您並歡迎參加 Akebia 2024 年第三季財務業績和業務更新電話會議。請注意，今天早些時候（11 月 7 日星期四）發布了一份新聞稿，詳細介紹了我們的第三季財務業績。為方便您的閱讀，您可以在我們網站的投資者部分查閱該新聞稿。

A replay of today's call will also be available on our website after we conclude. Joining me today, we have

會議結束後，我們網站上也將提供今天電話會議的重播。今天和我一起的還有

John Butler Chief Executive Officer, Nicholas Grund, Chief Commercial Officer and

John Butler 執行長、Nicholas Grund 首席商務長和

President, Chief Executive Officer & Director Erik John Ostrowski, chief Financial and Business Officer.

總裁、執行長兼董事 Erik John Ostrowski 兼財務與業務長。

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.

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。

Additional information describing these risks is included in the financial results press release that we issued on November 7th, 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 CEO John Butler.

描述這些風險的其他資訊包含在我們於 11 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。現在，我想介紹執行長約翰·巴特勒 (John Butler)。

Thanks Mercedes and thanks everyone for joining us today. You know, the AQB team has spent the past 15 years working to bring Vafseo to patients. So I have to say I get excited every time I have the opportunity to give an update on the progress we're making in the home stretch of that journey.

感謝梅賽德斯，也感謝大家今天的參與。您知道，AQB 團隊過去 15 年一直致力於將 Vafseo 帶給患者。因此我必須說，每次有機會報告我們在這段旅程的最後階段所取得的進展時，我都感到很興奮。

We're building significant momentum as we prepare for us, market availability of Vafseo that do that expected in January of '25 our team's work has yielded tremendous progress on each of our three launch initiatives.

我們正在為 Vafseo 的市場供應做準備，預計 25 年 1 月我們團隊的工作在我們的三個發布計劃上都取得了巨大進展。

First, at the prescriber level, we're driving demand. Second, we're focused on contracting effectively with dialysis organizations to have meaningful and have meaningful progress to share.

首先，在處方者層面，我們正在推動需求。其次，我們專注於與透析組織簽訂有效合同，以取得有意義的進展並進行分享。

And third, we've launched clinical initiatives to generate data that could demonstrate potential additional benefits of Vafseo for patients.

第三，我們已經啟動臨床計劃，以產生數據，證明 Vafseo 可以為患者帶來潛在的額外益處。

I recently returned from the American Society of Nephrology or ASN Kidney Week. As I mentioned previously, I considered this our coming out party, Tachia had a formidable presence focused on engagement across the kidney community, building awareness and advocacy for Vafseo.

我最近從美國腎臟病學會或 ASN 腎臟週回來。正如我之前提到的，我認為這是我們的亮相派對，Tachia 以強大的影響力致力於腎臟社區的參與，為 Vafseo 建立知名度和倡導。

It was impossible to miss us.

我們不可能不被注意到。

Here are my takeaways over and over again. I heard from nephrologists that they're ready for a new choice in anemia management for their, for their dialysis patients. And they want to ensure their patients have access considering the traffic to our medical affairs booth. The interest in reviewing our existing clinical data and analyses on Vafseo is at an all time high.

以下是我反覆總結的要點。我從腎臟科專家那裡聽說，他們已經準備好為透析患者提供新的貧血管理選擇。考慮到我們醫療事務展位的交通狀況，他們希望確保患者能夠順利就診。人們對審查我們現有的 Vafseo 臨床數據和分析的興趣空前高漲。

We presented six posters on Vafseo O data and our authors and partners spent their time delving into the findings and responding to physician questions.

我們展示了六張有關 Vafseo O 數據的海報，我們的作者和合作夥伴花時間深入研究研究結果並回答醫生的問題。

Now let Nick share more detail on prescriber demand and commercial efforts. But overall, I'm extremely encouraged by the optimism that I felt amongst our team and within the broader kidney community from caregivers and investigators, representatives from dialysis organizations and patient advocacy groups.

現在讓 Nick 分享更多有關處方者需求和商業努力的細節。但總的來說，我對我們團隊以及整個腎臟社區的護理人員和研究人員、透析組織的代表和患者權益團體所表現出的樂觀情緒感到非常鼓舞。

Akebia is committed to the kidney community and we believe we have widespread support to make Vafseo successful.

Akebia 致力於腎臟社區服務，我們相信我們得到廣泛的支持，以使 Vafseo 取得成功。

Now, prior to ASN Kidney Week, we also shared important updates regarding reimbursement contracting and access.

現在，在 ASN 腎臟週之前，我們也分享了有關報銷合約和取得的重要更新。

In October, we secured TDAPA reimbursement from CMS and we also received health care common procedure coding system or HPIS codes which allows dialysis organizations to submit for bafs reimbursement in January of 25.

10 月份，我們從 CMS 獲得了 TDAPA 報銷，同時我們也收到了醫療保健通用程序編碼系統 (HPIS) 代碼，這使得透析機構可以在 2015 年 1 月提交 bafs 報銷申請。

And just to remind everyone CMF created TDAPA reimbursement system to encourage the use of innovative products for patients on dialysis TDAPA creates positive economics for dialysis organizations that makes Vafseo a desirable addition to their formularies while receiving TDAPA reimbursement payment was our expectation. We're pleased to have the assurance provided by this program as we engage in further contracting discussions.

需要提醒大家的是，CMF 創建了 TDAPA 報銷系統，以鼓勵透析患者使用創新產品。我們很高興在進行進一步的合約討論時得到該計劃提供的保證。

Now that we have the hicks picks codes. Our key account managers can begin to educate dialysis organizations to ensure that these codes are known at each site to facilitate efficient Vafseo reubsument this quarter, we've also made progress on our effort to secure access to Vafseo through commercial supply contracts with dialysis providers and group purchasing organizations.

現在我們有了 Hicks 選秀代碼。我們的重要客戶經理可以開始培訓透析組織，確保每個站點都知道這些代碼，以促進本季度有效地重新使用 Vafseo，我們還在透過與透析提供者和團體採購組織簽訂商業供應合約來確保使用 Vafseo 方面取得了進展。

Nick will provide more details and speak to our goal of securing coverage for nearly 100% of patients on dialysis by the end of the year.

尼克將提供更多細節，並談到我們的目標，即在今年年底確保覆蓋近 100% 的透析患者。

Finally, we're progressing on plans to generate new clinical data in September. We initiated our vas outcomes in center experience or voice trial in partnership with us renal care, which we use three times per week dosing of Vafseo and allow us to generate important data on key endpoints such as mortality and hospitalization that can further educate the physician community and support vaso utilization.

最後，我們正在推進九月份產生新臨床數據的計畫。我們與腎臟護理部門合作，在中心體驗或語音試驗中啟動了血管結果，我們每週使用三次 Vafseo 劑量，這使我們能夠產生有關關鍵終點（例如死亡率和住院率）的重要數據，這些數據可以進一步教育醫生社區並支持血管利用。

This study intends to enroll 2,200 patients across us RC sites and we expect the first patient to be enrolled in the next few weeks.

這項研究計劃在美國 RC 站點招募 2,200 名患者，我們預計第一位患者將在未來幾週內招募。

Additionally, we're evaluating in initiating complementary trials at other dialysis organizations.

此外，我們正在評估在其他透析組織啟動補充試驗。

The interest among dos is also encouraging as it suggests, they're eager to understand how Vafseo can improve care for their patients as they gain real world experience, we believe generating additional clinical data will help further our objective for Vafseo to become the new oral standard of care for the treatment of anemia due to chronic kidney disease.

醫生們的興趣也令人鼓舞，因為這說明他們渴望了解 Vafseo 在獲得現實世界經驗後如何改善對患者的護理，我們相信生成額外的臨床數據將有助於進一步實現我們的目標，即讓 Vafseo 成為治療慢性腎病引起貧血的新的口服護理標準。

We look forward to working closely with us SRC and other dialysis organizations to advance our understanding of additional potential benefits Vafseo treatment can bring to dialysis patients.

我們期待與 SRC 和其他透析組織密切合作，以加深我們對 Vafseo 治療可以為透析患者帶來的其他潛在益處的了解。

Now, one final thought, I'll share regarding ASN kidney week based on conversations we continue to have with nephrologists.

現在，我將根據我們與腎臟病專家的持續對話，分享 ASN 腎臟週的最後一個想法。

And that is that the unmet need for anemia treatment for patients with CKD who are not on dialysis is more significant than ever and represents an additional multibillion dollar opportunity beyond the dialysis population.

這意味著，對於未接受透析的 CKD 患者來說，貧血治療的未滿足需求比以往任何時候都更為顯著，除了透析人群之外，還代表著數十億美元的額外機會。

That is a resounding message from physicians and at a sn we reiterated our commitment to exploring a path for Vafseo label expansion into the non dialysis patient population.

這是來自醫生的響亮訊息，我們重申了我們致力於探索將 Vafseo 標籤擴展到非透析患者群體的途徑。

As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year.

正如我們之前所說，我們預計將在今年年底前提供有關該計劃的更詳細的更新資訊。

Now, let me turn it over to Nick to talk more about our commercial activities.

現在，讓我讓尼克進一步談談我們的商業活動。

Thanks John, good morning folks. We continue to execute on our market readiness plans to foster and enable a strong market reception for Vafseo upon market availability. In fact, our sales team is focused nearly exclusively on Vafseo awareness and more importantly, demand is building building through our AC P education and patient identification efforts. We are also hard at work to complete commercial supply contracts, facilitate processes at dialysis center business level and set up our distribution network. The significant commercial contracts that we have established for VFU to date along with the Tadapa and Hicks picks codes we recently received, we believe will enable us to drive update within a significant percentage of the dialysis market. Immediately upon launch to recap. Our current commercial supply contracts include engagements with us, renal care.

謝謝約翰，大家早安。我們將繼續執行我們的市場準備計劃，以在市場有供應時促進 Vafseo 獲得強勁的市場接受度。事實上，我們的銷售團隊幾乎只專注於 Vafseo 知名度，更重要的是，透過我們的 AC P 教育和患者識別工作，需求正在增加。我們也正在努力完成商業供應合同，促進透析中心業務層面的流程並建立我們的分銷網絡。我們相信，迄今為止我們為 VFU 簽訂的重要商業合約以及我們最近收到的 Tadapa 和 Hicks 選擇代碼將使我們能夠在相當大比例的透析市場中推動更新。發射後立即進行回顧。我們目前的商業供應合約包括與我們合作的腎臟護理。

A dialysis organization serving 36,000 patients, one of the leading dialysis organizations in the US, serving more than 200,000 patients and thousands of dialysis centers. And most recently, an engagement with renal purchasing group, a specialty group purchasing organization that serves many of the independent and small dialysis organizations through our contracts with D OS and GB OS. Approximately 60% of patients on dialysis have access to vas the dialysis organizations and group purchasing organizations have been active participants in the contracting process and it's clear that leaders within the organizations share our commitment to delivering innovative treatments to people living with kidney disease.

一家服務於36,000名患者的透析組織，美國領先的透析組織之一，服務超過200,000名患者和數千個透析中心。最近，我們與腎臟採購集團進行了合作，該集團是一個專業的集團採購組織，透過與 D OS 和 GB OS 簽訂的合約為許多獨立和小型透析組織提供服務。大約 60% 的透析患者可以使用 VA，透析組織和團體採購組織一直積極參與承包過程，很明顯，組織內的領導者與我們一樣致力於為腎臟病患者提供創新治療。

We previously announced the Vafseo whack of approximately $15,500 per year. Our commercial supply contracts are coming together as we expected and include an off invoice discount and volume based rebates through the volume based rebates. As Vafseo use increases, the price will decline from an akebia perspective. This is a dynamic we welcome as it implies that if the price decreases the utilization and market share of vio is growing.

我們之前宣布過 Vafseo 的年薪將達到約 15,500 美元。我們的商業供應合約正如我們預期的那樣，包括發票外折扣和透過基於數量的回扣實現的基於數量的回扣。隨著 Vafseo 的使用量增加，從木通的角度來看，其價格將會下降。我們歡迎這種動態，因為這意味著如果價格下降，vio 的利用率和市場份額就會成長。

In addition, within the contracts, GEOS are assured of predictability of price post TDAPA when we expect the price of Vafseo to be essentially in line with the price of ESAs this pricing strategy. And our commitment to access, we believe will enable akebia to have a strong launch.

此外，在合約範圍內，當我們預計 Vafseo 的價格與 ESA 的價格基本一致時，GEOS 可以確保 TDAPA 之後價格的可預測性。我們相信，我們對資訊的承諾將使 akebia 獲得強勁發展。

We expect to generate revenue within the first two years of market availability by targeting the DAPA eligible patient population and other populations where access is enabled while we expect a price decrease post TDAPA in 2027. Again, we expect it will be offset by a potential volume increase as we will then be targeting the entire dialysis patient population. Not just those who were previously eligible for TDAPA .

我們預計透過瞄準符合 DAPA 條件的患者群體和其他可以獲得該藥物的群體，在市場上市後的頭兩年內創造收入，同時我們預計 2027 年 TDAPA 上市後價格會下降。再次，我們預計它將被潛在的數量增長所抵消，因為我們將針對整個透析患者群體。不僅限於那些先前已符合 TDAPA 資格的人士。

The anemia management market in dialysis alone today is approximately $1 billion in just the US.

目前光是在美國，透析貧血管理市場的規模就約 10 億美元。

Our intent is to enable broad access to baccio from dialysis organizations. With the goal of having agreements in place with dialysis organizations covering nearly 100% of dialysis patients.

我們的目的是使透析組織能夠廣泛地使用 baccio。目標是與透析組織達成協議，涵蓋幾乎 100% 的透析患者。

We continue to work on additional commercial supply contracts and with over 25% of patients not getting to go. We believe there is a compelling need to have an alternative therapy available.

我們繼續致力於額外的商業供應合同，但超過 25％ 的患者未能前往。我們堅信我們迫切需要一種替代療法。

I'll note that having the vio TDAPA in place along with Orix is upcoming TDAPA for, for the phosphate binder class. They're both additional levers that we can pull as we pursue additional commercial supply contracts.

我要指出的是，vio TDAPA 與 Orix 即將推出的 TDAPA 一起用於磷酸鹽結合劑類。它們都是我們在尋求更多商業供應合約時可以利用的額外槓桿。

Dialysis organizations are preparing for this distribution change. And as such, there are advantages of contracting across the akebia portfolio of products as demonstrated by 100% of our contracts to date include both products.

透析組織正在為這種分佈變化做準備。因此，簽訂涵蓋 akebia 產品組合的合約具有許多優勢，迄今為止我們 100% 的合約都包含這兩種產品。

We will continue to approach our commercial supply contract discussions accordingly.

我們將繼續相應地進行商業供應合約討論。

So contracting provides the access reimbursement ensures the coverage. But it's the caregivers who will determine what patients are appropriate for Vafseo and importantly, write the prescriptions for Vafseo.

因此，簽訂合約提供了報銷管道，確保了覆蓋範圍。但護理人員將決定哪些患者適合使用 Vafseo，重要的是，為 Vafseo 開出處方。

To that end. Our team has also been making good progress connecting with prescribers to drive awareness and demand. As a result, we have seen significant increases in awareness and importantly, 92% of physicians surveyed intended to use the product with a robust 27% of physicians intending to use the product within the first three months of launch with our field sales team. Now devoting nearly 100% of their time to vio.

為了這個目的。我們的團隊在與處方人員的聯繫以提高認識和需求方面也取得了良好的進展。結果，我們看到認知度顯著提高，更重要的是，92%接受調查的醫生打算使用該產品，27%的醫生打算在我們的現場銷售團隊推出產品後的前三個月內使用該產品。現在幾乎把 100% 的時間都投入了 vio 上。

We expect these measures to continue to grow.

我們預計這些措施將繼續推廣。

Nephrologists are very consistent in where they expect to use the product. Initially, the focus is on home patients as well as patients on the highest doses of E SAS.

腎臟科專家對於該產品的使用場合有著非常一致的期望。最初，重點是家庭患者以及服用最高劑量 E SAS 的患者。

These are segments where physicians attribute the greatest unmet need and they total more than 200,000 patients.

這些是醫生認為未滿足需求最大的領域，總計超過 20 萬名患者。

We believe prescribers will expand utilization of Vafseo beyond these patient groups. After gaining experience with the product and seeing the benefits of Vafseo for these initial patients.

我們相信，處方人員將會擴大 Vafseo 的使用範圍，使其不再局限於這些患者群體。在獲得了產品經驗並看到 Vafseo 為這些初始患者帶來的好處後。

The only additional insight to John's comments on A SN is regarding the high level of engagement whether it was in the booth in meetings with me, medical experts and do business personnel or in broader product theater type presentation. The thoughtfulness, excitement and quality demonstrated by the Akebia team allow for meaningful dialogue that progressed our goals.

對約翰對 A SN 的評論的唯一額外見解是關於高水準的參與度，無論是在展位上與我、醫學專家和商務人員會面，還是在更廣泛的產品劇院類型的演示中。Akebia 團隊所表現出的體貼、熱情和品質使得有意義的對話得以實現，從而推動了我們的目標。

And I got to say there's nothing more reassuring to a commercial person than walking into a trade show and seeing attendees a couple deep waiting to engage with our people and our content.

我想說，對於一個商業人士來說，沒有什麼比走進一個貿易展會，看到與會者排長隊等待與我們的員工和我們的內容進行交流更令人安心的了。

Overall, we are pleased with our progress in shaping the environment from Vafseo and are looking forward to putting revenue numbers on the board in quarter one.

總體而言，我們對 Vafseo 塑造環境的進展感到滿意，並期待在第一季公佈營收數字。

Let me now turn it over to Eric.

現在讓我把話題交給 Eric。

Hey Nick, as John and Nick have expressed, the team has been working incredibly diligently across a number of initiatives and excitement is building both internally and externally for availability of AC in the US. I'll now provide an overview of our third quarter. Financial results total revenue was $37.4 million in the third quarter of 2024 compared to $42 million in the third quarter of 2023. This consisted of $35.6 million of AURYXIA net product revenue.

嘿，尼克，正如約翰和尼克所表達的那樣，團隊一直在非常努力地開展多項計劃，內部和外部都對在美國推出空調感到興奮不已。我現在將概述我們的第三季。財務業績 2024 年第三季總營收為 3,740 萬美元，而 2023 年第三季總營收為 4,200 萬美元。其中包括 3,560 萬美元的 AURYXIA 淨產品收入。

As compared to $40.1 million of AURYXIA net product revenue. During the third quarter. On '23 the decrease was primarily due to a reduction in volume, partially offset by price increases and execution of our contracting strategy with third party payers looking forward. Despite the fact that we believe overall market demand for Oryx and other phosphate binders has been steady throughout this year. We expect Oryx net product revenue in fourth quarter of 2024 will be around the level of our net product revenue from Q2 of this year which is lower than the fourth quarter of 2023.

相比之下，AURYXIA 的淨產品收入為 4,010 萬美元。在第三季。23日的下降主要是由於銷量減少，但部分被價格上漲和與第三方付款人執行的合約策略所抵消。儘管我們相信，今年 Oryx 和其他磷酸鹽結合劑的整體市場需求一直保持穩定。我們預計 Oryx 2024 年第四季的淨產品收入將與今年第二季的淨產品收入水準大致相同，低於 2023 年第四季。

This is being driven by the anticipated disruption to the supply chain for the drive phosphate finder class in late 2024 ahead of 2025 to adapt a reimbursement for this category. More specifically, we expect distribution will largely shift away from wholesalers to dialysis organizations which will in turn decrease wholesaler inventory stocking license, collaboration and other revenue was steady at $1.8 million in the third quarter of 2024. As compared to $1.9 million in the third quarter of 2023 cost of goods sold was $14.2 million in the third quarter of 2024. Compared to $18 million. In the third quarter of 2023. The decrease was driven by a $3.7 million benefit due to our ability to commercially sell inventory previously written down as excess inventory research and development expense decreased to $8.5 million in the third quarter of 24 as compared to $13.3 million in the third quarter of 2023 which was driven by the completion of activities related to certain clinical trials, lower head count related costs and decreased professional service and consulting expense.

這是由於預計 2024 年底驅動磷酸鹽查找器類的供應鏈將中斷，以便在 2025 年之前適應此類別的報銷。更具體地說，我們預計分銷將主要從批發商轉移到透析組織，這反過來又會減少批發商庫存，許可證、合作和其他收入在 2024 年第三季穩定在 180 萬美元。與 2023 年第三季的 190 萬美元相比，2024 年第三季的銷售成本為 1,420 萬美元。相比之下，為 1800 萬美元。2023年第三季。減少的主要原因是，我們能夠商業銷售先前減記為過剩庫存的庫存，從而獲得了 370 萬美元的收益，研發費用從 2024 年第三季度的 1,330 萬美元減少至 2024 年第三季度的 850 萬美元，而 2023 年第三季的 1,330 萬美元

SG&A expense was $26.5 million in the third quarter of 2024 an increase from $22.7 million in the third quarter of 2023. This increase was driven by costs incurred in connection with pre launch activities related to that product availability in the US.

2024 年第三季的銷售、一般及行政費用為 2,650 萬美元，高於 2023 年第三季的 2,270 萬美元。這一增長是由於與該產品在美國上市相關的預發布活動所產生的成本。

And lastly net loss was $20 million in the third quarter of 2024. Compared to a net loss of $14.5 million in the third quarter of 2023. The increase in net loss included $4.4 million in non cash interest expense related to the settlement royalty liability. In connection with the D four termination.

最後，2024 年第三季的淨虧損為 2,000 萬美元。相比之下，2023 年第三季的淨虧損為 1,450 萬美元。淨虧損的增加包括與和解特許權使用費責任相關的440萬美元非現金利息支出。與 D4 終止有關。

We ended the quarter with $34 million in cash and cash equivalents and consistent with prior guidance have at least two years of cash, runway post Q3. We raised $9.7 million in net proceeds from our ATM facility bringing pro Forma end of QQ three cash to $43.7 million with an established sales force and supply of bas inventory in hand. I am pleased to say we stand well positioned from a financial point of view for bas us product availability in January and with that, we welcome questions.

本季結束時，我們的現金和現金等價物為 3,400 萬美元，與先前的指引一致，我們至少擁有兩年的現金儲備，可供第三季後使用。我們從 ATM 設施籌集了 970 萬美元的淨收益，使 QQ 三現金的預計期末金額達到 4,370 萬美元，同時擁有一支成熟的銷售隊伍和充足的庫存供應。我很高興地說，從財務角度來看，我們在 1 月份的產品供應方面處於有利地位，因此，我們歡迎您提出問題。

(Operator Instructions)

（操作員指令）

Allison Bratzel , Piper Sandler. Your line is open.

艾莉森‧布拉澤爾，派珀‧桑德勒。您的線路已開通。

Hey, good morning guys. And thanks for taking the questions. Just a couple for me. Just on the potential for label expansion and non non dialysis. Could you sort of frame kind of what kind of update on the regulatory interactions? You know, we can be expecting and just kind of what are the potential range of outcomes from those, those regulatory interactions in the, in the terms of, in terms of defining a path to non dialysis approval. And then I think you covered this in the prepared remarks but a little bit, but it seems like AKI I did have a really big presence at a sn just hoping you could characterize the kind of feedback you've been getting from docs on that, you know, are there any themes that stand out that you'd like to call out?

嘿，大家早安。感謝您回答這些問題。對我來說只有一對。僅就標籤擴展和非非透析的潛力而言。您能否概括一下監理互動方面的更新？您知道，我們可以預期，在定義非透析核准途徑方面，這些監管互動可能產生哪些結果。然後我認為您在準備好的評論中稍微涉及了這一點，但似乎 AKI 我在 sn 中確實有很大的存在感，只是希望您能夠描述一下您從文檔中得到的反饋類型，您知道，是否有任何突出的主題您想要指出？

Thank you.

謝謝。

Great, thanks, Ally. So the first question on NDD label expansion. So, you know, as we've said, we expect to engage with FDA this year, you know, it, it's kind of hard to say what the outcome will be of that until we have the engagement. And you know, so, but our expectation is and what we want is we know we have to do clinical work to get an NDD label.

太好了，謝謝，Ally。第一個問題是關於NDD標籤擴展。所以，正如我們所說的，我們希望今年與 FDA 合作，你知道，在我們合作之前很難說結果會是什麼。你知道，但我們的期望是，我們想要的是，我們知道我們必須做臨床工作才能獲得 NDD 標籤。

That's, you know, that was clear in the, in the CRL. You know, as we've said before, they were open to, you know, said in the CRL, come back and discuss your patient group that, that makes sense for where the benefit risk is positive, right? So, you know, we believe we've outlined that and are looking to engage with them on that conversation and what a protocol would look like, what a study would look like to get there, you know, as well as I and you know, it's not like the FDA is going to say, yeah, that's great.

您知道，這在 CRL 中已經說得很清楚了。您知道，正如我們之前所說的那樣，他們願意，您知道，在 CRL 中說過，回來討論您的患者群體，這對於收益風險為正的情況來說是有意義的，對嗎？所以，你知道，我們相信我們已經概述了這一點，並希望與他們就這一對話進行交流，以及協議是什麼樣的，研究是什麼樣的，你知道，正如我和你知道的，這並不意味著 FDA 會說，是的，那太好了。

Do that and, and you'll get approved, right? I mean, everything will always be a review issue but you want to know that you have alignment that you're delivering a protocol study that they will view positively and that's, that's our hope and that's what we hope to be able to to describe to folks that, you know, we have a clinical path that makes sense for us that we can do and, you know, for a reasonable amount of money and a reasonable amount of time that will deliver to FDA the data that they need to to approve the product for, for non dialysis. Again. I mean, they recognize that there's a high end that need, I mean, sort of, leaking into your second question.

這樣做你就會獲得批准，對嗎？我的意思是，所有事情都終歸是審查問題，但您要知道，您提供的方案研究是一致的，他們會積極看待的，這是我們的希望，也是我們希望能夠向人們描述的，您知道，我們有一個對我們來說有意義的臨床路徑，我們可以以合理的金錢和合理的時間向 FDA 提供他們批准非透析產品所需的數據。再次。我的意思是，他們認識到存在一個高端需求，我的意思是，這有點滲透到你的第二個問題。

You know, every patient group that I spoke to, at a SN and we spoke to them all, individually, you know, they talked about the non dialysis, opportunity. So, you know, I'd expect them to engage with the FDA as well. But it will be a little bit of, you know, when we get the feedback, we, we'll know exactly what we'll be able to share with you, but we do expect it will be and give some clarity about kind of how we'll move forward.

您知道，我在 SN 與之交談過的每個患者群體，我們都與他們單獨交談過，您知道，他們談到了非透析的機會。所以，你知道，我希望他們也能與 FDA 合作。但當我們收到回饋時，我們就會確切地知道我們能夠與你們分享什麼，但我們確實期待它會，並明確我們將如何前進。

And it's never just one interaction, right? That first interaction, you know, gives you a path and then you continue to to interact with them to make sure you're delivering them what they need to facilitate the, the the approval.

而且它從來不只是一次互動，對嗎？您知道，第一次互動會為您提供一條路徑，然後您可以繼續與他們互動，以確保您向他們提供了他們所需的信息，以促進他們獲得批准。

And the second question I'll start and I'll pass it to Nick. But, you know, we had so many interactions over the the course of the week. And, you know, one of the things that I we tried to make come through in the script was just the optimism from folks who've been working with us for years to make this product available. I mean, we, you know, our roots are so deep in this community and, you know, so many folks have worked hard to to help us bring Vafseo to this, to this point.

我先提出第二個問題，並將其交給尼克。但您知道，我們在這一周中進行了非常多次的互動。你知道，我們在劇本中嘗試表現出來的一件事就是那些多年來一直與我們合作讓這款產品面世的人們所抱持的樂觀態度。我的意思是，你知道，我們在這個社區的根基非常深厚，你知道，很多人都努力幫助我們將 Vafseo 帶到這一點。

I think everyone was excited for us and for themselves that they have this opportunity to, you know, to make the product available for sure. That doesn't mean, you know, no one's written a prescription yet. Right. I mean, we still have to execute. Absolutely.

我想每個人都為我們和他們自己感到興奮，因為他們有這個機會可以確保產品能夠供應。但這並不代表還沒有人開出處方。正確的。我的意思是，我們還得執行。絕對地。

But, you know, I think it starts with that, that level of positivity, whether it was the Kmes who've been part of our steering committee or the patient groups that I referenced investigators who you know came up to me at the reception that we had, you know on the Wednesday night and you know when we talked about our commitment to NDD, they came up and talked about wanting to be part of that study because they've been part of studies we've done in the past. You know really feel strongly about the drug.

但是，你知道，我認為一切都始於那種積極性，無論是作為我們指導委員會成員的 Kmes 還是我提到的患者團體研究人員，他們在我們星期三晚上的招待會上向我走來，當我們談到對 NDD 的承諾時，他們走上前來，表示希望參與這項研究，因為他們曾參與過我們過去所做研究。您確實對這種藥物有強烈的感覺。

I mean all of those, I think just puts us in a really positive spot and a really differentiated spot versus you know other, his products that have launched without that kind of commitment and excitement and, but I know Nick have a lot of interactions as well, so I'll pass it to him.

我的意思是，我認為所有這些，都讓我們處於一個非常積極的位置，一個與其他產品截然不同的位置，你知道，他的其他產品推出時都沒有那種承諾和興奮，但我知道尼克也有很多互動，所以我會把它傳遞給他。

Yeah. No, it's a great question is, you know, my takeaways are really three early in the year while people were interested in Vafseo the urgency was much less than you see. Now, now it's a, when can I get it? Is it contracted? Do I have access? What does the distribution look like very specific granular questions? That mean they're on the verge of implementing something within their center?

是的。不，這是一個很好的問題，你知道，我的收穫實際上只有三點，在今年年初，雖然人們對 Vafseo 感興趣，但緊迫性卻比你看到的要低得多。現在，現在是，我什麼時候可以得到它？簽約了嗎？我可以訪問嗎？分佈看起來像是什麼非常具體的細粒度問題？這是否意味著他們即將在中心實施某項措施？

Second John mentioned it in his prepared remarks. The level of clinical questions we're getting now, aren't you know so much of hey who do you think I should use it in? It's what's the dose? How do I start them? When do I stop the prior therapy? Very specific that indicate a desire to write the prescription for patients in need.

約翰二世在他準備好的演講中提到了這一點。我們現在遇到的臨床問題的水平，難道您不知道嗎，您認為我應該在誰身上使用它？它的劑量是多少？我該如何啟動它們？我什麼時候應該停止之前的治療？非常具體，顯示願意為有需要的患者開處方。

And lastly, many of the physicians I talked to, we're really highlighting the need for an alternative therapy. They look at that at us as potentially a standard of care. But they're also second to that realizing the shortcomings of their current es A therapies. And so that need is, is really brought forward in that not only is there a patient need, there's also a product need. So those are my three takeaways.

最後，與我交談過的許多醫生確實強調了替代療法的必要性。他們認為這對我們來說是一種潛在的護理標準。但他們也意識到了現行 es A 療法的缺點。所以這種需求其實是不僅存在患者需求，還存在產品需求。這就是我的三個收穫。

Yeah, honestly I mean, sometimes you have physicians who are naming numbers, right? I mean, I, and it's, you know, we've all been associated with nephrology launches before, right? I mean, they'll, will name numbers, but it still takes them a long time to do things. And we, that's why it's been so nice to have this time pre product availability to kind of wade through some of that inactivity and, and get to the place where, where Nick just described. Does that help?

是的，說實話，有時候醫生會說出數字，對嗎？我的意思是，你知道，我們之前都參與過腎臟病學的發布，對吧？我的意思是，他們會說出數字，但仍然需要很長時間才能完成事情。這就是為什麼我們很高興能在產品上市前的這段時間裡渡過一些難關，並到達 Nick 剛剛描述的地方。這樣有幫助嗎？

Yeah, that helps a lot. Thanks guys.

是的，這很有幫助。謝謝大家。

Thank you.

謝謝。

Ed Arce , HC Wainwright. Your line is open.

艾德阿爾斯、HC溫賴特。您的線路已開通。

Hi guys. Good morning. And congrats on all the and all the good work at San Diego recently. Couple questions for me and then maybe a follow up. Firstly, you, you mentioned on your release that you're now at approximately 60% of the dialysis centers with supply contracts. I'm wondering if if you had a certain goal in mind by launch date in January. And, and how much further do you think you can get by then?

嗨，大家好。早安.並祝賀最近聖地亞哥的所有出色工作。問我幾個問題，然後也許進行後續跟進。首先，您在發布會上提到，您現在與大約 60% 的透析中心簽訂了供應合約。我想知道您是否在 1 月發布日期之前設定了特定的目標。那麼，您認為到那時您還能走多遠呢？

And then secondly, around the voice trial, I know you said you're, you're looking to start enrollment here in a few weeks. I wondering if you could discuss sort of the timeline of that trial and as you get data, how that could impact actual prescribing and administration of the drug once launched. Thank you.

其次，關於語音試驗，我知道您說過您希望在幾週後開始在這裡註冊。我想知道您是否可以討論該試驗的時間表，以及當您獲得數據時，這將如何影響該藥物上市後的實際處方和管理。謝謝。

Thanks, Ed. So I'm going to do the second first and then I'm going to hand it to Nick to talk about the and the dialysis center. So, the voice trial and again, which is a collaborative research study with us Renal care. And, and Jeff Block is the, the lead investigator on that. And you know we've worked with Jeff, I've worked with Jeff for 20 something years.

謝謝，埃德。所以我將首先做第二個，然後將把它交給尼克來討論透析中心。因此，再次進行聲音試驗，這是與我們的腎臟護理合作的研究。傑夫‧布洛克 (Jeff Block) 是這項研究的首席研究員。你知道我們和傑夫合作過，我和傑夫合作了 20 多年。

He's an amazing trialist and, you know, he gets studies enrolled incredibly efficiently and, you know, I couldn't be happier that he was very excited about about working on this trial with us. I've seen some of the materials he's put together to help with enrollment and it really runs a professional organization. But so, you know, I guess as I said, we expect to see the first patient enrolled within the next few weeks and we hope that this is a quick enrollment. I mean, it's very broad inclusion criteria. You know patients on dialysis, very few exclusions for that.

他是一位出色的試驗者，你知道，他以極其高效的效率開展研究，你知道，他對於和我們一起進行這項試驗感到非常興奮，我對此感到非常高興。我看過他為幫助入學而整理的一些材料，它確實是一個專業的組織。但是，正如我所說的，我們預計將在接下來的幾週內看到第一位患者入組，我們希望這是一個快速的入組。我的意思是，它的納入標準非常廣泛。您知道，接受透析治療的病人很少被排除在外。

You know, the goal is you know we haven't talked about when we expect it to be you know, fully enrolled or completed, but it is an outcome study, right? So, you know, there's a an amount of follow up after the last patient enrolled that everyone every patient in the study will have at least you know a set amount of follow up. So, but the goal is we think about study is a it's using three times weekly dosing, right? So, you know, that gives us RC a significant amount of experience using that dosing regimen, makes the investigators com comfortable with that. And, you know we think that will impact how they think about protocols at us RC and probably beyond us RC. When others you know see that this very significant dialysis provider is is using that dosing regimen successfully.

你知道，我們還沒有談論我們期望它何時能夠完全入學或完成，但這是一項結果研究，對嗎？因此，您知道，在最後一位患者入組後，會進行一定量的跟進，研究中的每一位患者都會至少接受一定量的跟進。所以，但我們考慮研究的目標是每週使用三次劑量，對嗎？所以，您知道，這為我們 RC 使用該給藥方案提供了豐富的經驗，使研究人員對此感到滿意。而且，您知道，我們認為這將影響他們對美國 RC 以及美國 RC 以外的協議的看法。當您認識的其他人看到這家非常重要的透析服務提供者正在成功地使用該給藥方案時。

So we think that will have a very important near term impact. But the reason that we're doing the study is to generate this data and you know, that we believe will show a benefit and, and you know, think about it, we've got two years of TDAPA reimbursement.

因此我們認為這將產生非常重要的短期影響。但我們進行這項研究的原因就是為了產生這些數據，你知道，我們相信這些數據會顯示出好處，而且你知道，想想看，我們有兩年的 TDAPA 報銷。

At the end of those two years, we have to lower the price of of VC. But now we, we get to fish in the entire pond if you will, right? I mean, the entire dialysis population will be available to us. We, the way we think about it is physicians get experience using it in those patients where there's a TDAPA benefit, they like the product. You know, they, they see how well it works for patients, then you generate additional positive data and you know, that allows that next step of becoming standard of care, really penetrating that market quite significantly.

兩年後，我們必須降低 VC 的價格。但是現在，如果你願意的話，我們可以在整個池塘釣魚，對嗎？我的意思是，所有接受透析治療的人都可以為我們服務。我們的想法是，醫生在那些具有 TDAPA 益處的患者身上獲得了使用它的經驗，他們喜歡該產品。你知道，他們看到它對病人的效果有多好，然後你產生額外的正面數據，你知道，這使得下一步成為護理標準，真正滲透到那個市場。

And the third step is you have non dialysis approval and then when patients arrive on dialysis, they arrive on Vafseo. So getting data from voice as soon as possible after the TDAPA period ends or before again, it really depends on how quickly we enroll. But this isn't a study that's supposed to last, you know, five or six years. This is one that, that we expect will move quite quickly and, the dialysis contracting there.

第三步是您獲得非透析批准，然後當患者進行透析時，他們就會到達 Vafseo。因此，在 TDAPA 期限結束後或之前盡快取得語音數據，這實際上取決於我們註冊的速度。但這項研究預計不會持續五、六年。我們預計，這項計畫將進展相當快，透析也將在那裡進行。

Yeah, as you said we're at about 60% now. Goal, this might sound like it's lacking humility. Our goal is to hit 100%. And it's based on really three important things. One, there's a reimbursement mechanism in place from C MS cap that supports the use of innovative drugs during the two year period. Second, our pricing strategy, we've created a pricing strategy that should allow for the D OS to have good economics during the TDAPA period around our product.

是的，正如您所說，我們現在已完成約 60%。目標，這聽起來可能缺乏謙遜。我們的目標是達到100%。它實際上是基於三件重要的事情。一是，C MS cap 有一個報銷機制，支持在兩年期間使用創新藥物。第二，我們的定價策略，我們已經制定了一個定價策略，可以讓 D OS 在 TDAPA 期間圍繞我們的產品獲得良好的經濟效益。

And importantly, we've created predictability post TDAPA through matching or very, very similar to ES A pricing. And then lastly, none of those things really matter. Unless there's a clinical need, there is a clinical need. Over 25% of patients still are not getting to goal on today's quote unquote standard of care. And we believe that vas gives those patients an opportunity to get to goal.

重要的是，我們透過匹配或非常類似於 ES A 定價，創建了 TDAPA 後的可預測性。最後，這些事情都不重要了。除非有臨床需要，否則就有臨床需要。超過 25% 的患者仍然沒有達到當今所謂的標準治療。我們相信 vas 為這些患者提供了實現目標的機會。

So 100% is absolutely our goal. Remember, you know, there are two providers, one of whom we have under contract already who represent, you know, about 70%. So, you know, where a lot of our efforts are focused. And just to, to one quick follow up to clarify on on the voice study you know we have recall we have the focus study which we expect to be published any day but accepted for publication.

所以 100% 絕對是我們的目標。請記住，有兩家供應商，其中一家我們已經簽訂了合同，其份額約為 70%。所以，你知道，我們很多的努力都集中在那裡。只是為了快速跟進語音研究，您知道我們記得我們有重點研究，我們預計它會在任何一天發布，但已被接受發表。

You know we expect it to be online any day. Now. We think that, that work is sufficient to go to the FDA and, and have the TIW dosing added to our label, recall.

您知道我們期待它每天都能上線。現在。我們認為，只要向 FDA 提交申請並將 TIW 劑量添加到我們的標籤中，就可以了。

You know, we've made the strategic decision to focus on NDD first and then go do and talk to them about Tiw after, you know as we will have the focus, publication and dialysis providers will be you know getting that experience. But we don't, we don't think we need the voice study for for FDA approval. We, we really think about that as a way to generate more data to help expand access to the product, post to APA.

您知道，我們已經做出了戰略決策，首先關注 NDD，然後再去做並與他們討論 Tiw，您知道，我們將重點關注出版物和透析提供商，您將獲得這種經驗。但是我們不認​​為我們需要透過聲音研究來獲得 FDA 的批准。我們確實認為這是產生更多數據的一種方式，有助於擴大對產品的訪問，並發佈到 APA。

All right, great. And then just one follow up. I noticed you made the point that right now 100% of the contracts that you, you've signed with the, the DO s include both that Vio and AURYXIA.

好的，太好了。然後只需進行一次跟進。我注意到你指出，目前你與 DO 簽署的所有合約 100% 都包括 Vio 和 AURYXIA。

And A as we, you know look to generics of AURYXIA are coming in pretty soon. I'm wondering if you can discuss, you know, the efforts you, you, you've mentioned previously around maintaining those revenue levels as, as close to as what they are now as possible.

正如我們所知，AURYXIA 的仿製藥很快就會上市。我想知道您是否可以討論一下您之前提到的為盡可能維持當前收入水平而做出的努力。

Yeah, it's, you know, AURYXIA has been such an important part of the past year for us. You know, Nick kind of referenced it. I, you know, dialysis providers allowed us in, you know, to talk about contracting vaio because they needed to get contracts for, for AIIA put in place. And, it really has enabled a lot of these contracting discussions and has been incredibly important for us.

是的，你知道，AURYXIA 對我們來說是過去一年非常重要的一部分。您知道，尼克曾經提到過這一點。你知道，透析服務提供者允許我們談論簽訂合同，因為他們需要與 AIIA 簽訂合約。它確實促進了很多合約討論，對我們來說非常重要。

You know, we are again, we have those risk contracts in place. We know that, you know, that providers are looking at that addition of the, of the binders to the bundle and thinking about that process that happened with Calce and Parsabiv and, you know, using those branded products for two years so that, you know, they have kind of there, there's a larger number added to the bundle at the end of of that two year process.

您知道，我們再次簽訂了這些風險合約。我們知道，供應商正在考慮將黏合劑添加到捆綁包中，並思考 Calce 和 Parsabiv 所經歷的流程，並且使用這些品牌產品兩年，這樣，在兩年流程結束時，捆綁包中添加了更多的黏合劑。

We do not know exactly what's going to happen with the, the and the filers for for AIIA, right? I mean, there's, there were six ANDA filers, there's no andas that have been conditionally approved at this point in time. So, you know, we don't know who's going to introduce products at the end of, at the end of March. If anyone, of course, you know, you've got your, your first filer generally and an authorized generics.

我們並不確切知道 AIIA 的申報者會發生什麼事情，對嗎？我的意思是，有六個 ANDA 申請人，目前還沒有獲得有條件批准的 ANDA。所以，你知道，我們不知道誰會在三月底推出產品。當然，如果有人知道，你通常有你的第一個文件和授權的仿製藥。

So it'll be limited competition for most of 2025. I think that allows us to to maintain, you know, stronger access for AIIA on a branded basis, all of those pieces put together for 25 we're very conservative as we think about 26 and even towards the end of 25.

因此，2025 年的大部分時間裡競爭都會有限。我認為這使我們能夠在品牌基礎上維持對 AIIA 的更強大的訪問權限，將所有這些部分放在一起，對於 25 年來說，我們在考慮 26 年，甚至 25 年末時非常保守。

You know, call it the fourth quarter of 25. But before that, we think there's great opportunity and the way we've built our, our contracts, we're able to maintain revenue. You know, even if at a lower price, if we choose to and, you know, that is, that's important because there is power in that, in that portfolio. And Nick, I know if there's anything to add there.

您知道，稱之為 25 的第四季。但在此之前，我們認為有很大的機會，而且我們建立合約的方式能夠維持收入。你知道，即使價格較低，如果我們選擇這樣做，那很重要，因為這個投資組合中有權力。尼克，我知道還有什麼需要補充。

No, I think you had it all. I mean, again, it's the predictability that being with the branded manufacturer that we can provide and having that opportunity to reduce our price if needed be due to generic competition. It allows them not to have to spend the operational cost to switch and enter a generic formulation into their protocol and generics come and go into the marketplace over time.

不，我認為你已經擁有了一切。我的意思是，這是可以預見的，我們可以與品牌製造商合作，並有機會在必要時降低價格，這是由於通用產品的競爭。這使得他們不必花費營運成本來轉換並將通用配方納入他們的協議中，並且仿製藥會隨著時間的推移而進入市場。

I think it provides the DOS with a bit of peace of mind that we have the ability to be there throughout the generic process if you will.

我認為它為 DOS 提供了一點安心，因為如果你願意的話，我們有能力在整個通用過程中參與其中。

And we're there as a partner for the dialysis providers with AURYXIA. Again, I mean AURYXIA long term, we know that the the growth of of, of AKI and the value we're driving is is being driven by Vafseo , right? Long term, I mean, this is, you know, I hate to say it this way but II I think of AI as a tool to enable that Vafseo growth, right? I mean, it is something, it's a great product, a product they want on formulary. They want to be able to use, they needed to to have contracts in place.

我們是 AURYXIA 透析服務提供者的合作夥伴。再說一次，我的意思是從長遠來看，我們知道 AKI 的成長和我們推動的價值是由 Vafseo 推動的，對嗎？從長遠來看，我的意思是，你知道，我不想這樣說，但我認為人工智慧是實現 Vafseo 成長的工具，對嗎？我的意思是，它是一款很棒的產品，是他們想要列入處方的產品。他們希望能夠使用，他們需要簽訂合約。

And and we're there to support them through that and we believe that will help them to make the decision to incorporate bio as well. So it's a very important part of our commercial thinking but not part of our strategic growth story. Longer term.

我們會盡力為他們提供支持，並相信這也會幫助他們做出納入生物技術的決定。因此，這是我們商業思維中非常重要的一部分，但不是我們策略成長故事的一部分。更為長期。

Got it. Thanks so much.

知道了。非常感謝。

Julian Harrison ,BT IG. Your line is open.

朱利安·哈里森，BT IG。您的線路已開通。

Hi, good morning. Congrats on all the momentum and thank you for taking my questions. It's great to see the progress on the contracting front for BC. I'm wondering if you're able to share approximately what percent of the home dialysis segment is contracted at this time. Is it approximately 60% higher or lower than that? And then also for your earlier stage programs like acute kidney injury. Are you giving any guidance now for how soon you plan to be in the clinic for those efforts? If you could talk about the remaining steps of first in DS, that would be helpful as well.

嗨，早安。恭喜您取得的所有進展，並感謝您回答我的問題。很高興看到 BC 在承包方面取得的進展。我想知道您是否可以分享目前家庭透析領域的簽約比例大約是多少。大約是高出還是低出 60% 左右？然後也適用於早期項目，例如急性腎損傷。現在您能否就計劃何時在診所進行這些工作給予任何指導？如果您能談談 DS 中剩下的第一步，那也會很有幫助。

Nick the home.

尼克的家。

Yeah. And so while you know, the percent home in each dialysis organization changes a little bit, both the home as well as the in center population are included in all of our contracts. So none of our contracts excluded. Ultimately, it'll come down to as we suggested writing the protocol. But the two populations that come to mind when we talk to physicians is certainly the home PD population and the high dose esa And so in reality, there's probably very little difference between the percentage, 60% approximately that we have on the overall and how that splits up between home and in center.

是的。因此，儘管您知道，每個透析組織的家庭百分比會略有變化，但家庭和中心人口都包含在我們所有的合約中。因此我們的合約均未被排除。最終，它將歸結為我們建議的編寫協議。但是，當我們與醫生交談時首先想到的兩個人群肯定是家庭 PD 人群和高劑量 esa，因此實際上，總體百分比（大約 60%）與家庭和中心之間的分配百分比之間可能差別很小。

Thanks for that. So, Julian, thanks so much for the question on our early programs. I know that you know, everyone's focus is on vaio launch and, and it's, it's our focus as well, right? We know we need to do that that incredibly well. But at the same time, we're really excited about about our early stage programs and, you know, we really think a lot about, you know, kind of the future growth of the company and, you know, what will fuel our growth in the future.

謝謝。所以，朱利安，非常感謝您就我們早期的專案提出的問題。我知道，每個人的注意力都集中在 Vaio 的發布上，這也是我們的重點，對嗎？我們知道我們需要做得非常好。但同時，我們對我們的早期專案感到非常興奮，我們確實考慮了許多公司未來的發展，以及什麼將推動我們未來的發展。

And, and so, a TB 9090, which is the, the A K I program that you referenced we're in you know, kind of pre IND development now, you know, doing tax work, etcetera. And, you know, our goal is to have it in the clinic before the end of next year, as we've said before. And we seem to be on track for that. And, you know, it's an early stage program.

所以，TB 9090，也就是您提到的 A K I 計劃，我們現在處於 IND 前期開發階段，從事稅務工作等等。而且，您知道，我們的目標是在明年年底之前將其投入臨床，正如我們之前所說的那樣。我們似乎正在朝著這個目標前進。而且您知道，這是一個早期階段的專案。

So, you always have to kind of hold on tight. But you know, we're, we're quite excited about that and then of course, 10108, our program in redtop of prematurity, which I'm equally if not more excited about. You know, is behind 9090.

所以，你必須時時堅持下去。但你知道，我們對此感到非常興奮，當然，10108 是我們的早產紅頂計劃，我對此同樣感到興奮，甚至更加興奮。你知道，後面是9090。

But we are, we're moving that product forward doing C MC work, etcetera. You know, we had an advisory board meeting on one on 18 on written off the prematurity couple of months ago, I guess now. And you know, I remember texting Steve Burke our CMO during the meeting and just talking about how we have to move faster.

但我們正在透過 C MC 工作等推動該產品的發展。您知道，幾個月前，我們於 18 日召開了一次顧問委員會會議，討論取消早產的問題，我想現在就是這樣了。你知道，我記得在會議期間給我們的首席營銷官史蒂夫·伯克發短信，談論我們必須加快行動。

You know, these, these folks were just so excited about the opportunity that product could could have and in that population of neonates. So we're really excited about moving that one forward, but that one clearly is, is not going to be in the clinic next year. But, you know, hopefully, as soon after 9,090 as, as we can move it. But I appreciate that question.

您知道，這些人對於該產品可能為新生兒群體帶來的機會感到非常興奮。因此，我們對這項研究的進展感到非常興奮，但很明顯，這項研究明年不會在臨床上進行。但是，您知道，希望在 9,090 之後我們能夠盡快移動它。但我很感謝這個問題。

Thank you. This concludes the question and answer session. I would now like to turn it back to John Butler CEO for closing remarks.

謝謝。問答環節到此結束。現在我想請執行長約翰·巴特勒 (John Butler) 致最後總結。

Thanks, operator.

謝謝，接線生。

In summary, our contracting is going extremely well and we're very well positioned for a running start when VAS is available in January, the near and long term commercial success of AIO hinges. On our ability to execute on these initiatives we discussed today, but I'm pleased to say we've been hitting on every internal metric.

總而言之，我們的承包進展非常順利，我們已經做好了充分準備，可以在 1 月 VAS 上市時搶佔先機，這是 AIO 鉸鏈的近期和長期商業成功。關於我們今天討論的執行這些舉措的能力，但我很高興地說我們已經達到了每一個內部指標。

We look forward to seeing many of you during our investor meetings later this year. And then in San Francisco in January, we look forward to updating you on our progress then. Thanks everyone. Have a great day.

我們期待在今年稍後的投資者會議上見到你們。然後，我們期待於一月份在舊金山嚮您通報我們的進展。謝謝大家。祝你有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。