Akebia Therapeutics Inc (AKBA) 2024 Q2 法說會逐字稿

Thank you for standing by. My name is Andrea, and I will be your conference operator today. At this time, I would like to welcome everyone to the Akebia's second quarter 2024 financial results. (Operator Instructions) I would now like to turn the call over to Mercedes Carrasco, Senior Director, Investor Relation banking. Please go.

謝謝你的支持。我叫安德里亞，今天我將擔任你們的會議操作員。在此，我歡迎大家關注 Akebia 2024 年第二季財務表現。（操作員指示）我現在想將電話轉給投資者關係銀行業務高級總監 Mercedes Carrasco。請走吧。

Thank you, and welcome to Akebia's second quarter 2024 financial results and business update conference call. Please note that a press release was issued earlier today, Thursday, August 8, detailing our second quarter financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will be available on our website after we conclude.

謝謝，歡迎參加 Akebia 2024 年第二季財務表現與業務更新電話會議。請注意，今天早些時候（即 8 月 8 日星期四）發布了一份新聞稿，詳細介紹了我們第二季度的財務業績，該新聞稿可在我們網站的投資者部分獲取。為了您的方便，今天的電話會議結束後，我們將在我們的網站上提供重播。

Joining me for today's call, we have John Butler, Chief Executive Officer, Nik Grund, Chief Commercial Officer, and Erik Ostrowski, Chief Financial and Business Officer.

與我一起參加今天的電話會議的有首席執行官約翰·巴特勒(John Butler)、首席商務官尼克·格倫德(Nik Grund) 以及首席財務和業務官埃里克·奧斯特羅夫斯基(Erik Ostrowski)。

I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on August 8, as well in the risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC.

我想提醒大家，這次電話會議包含前瞻性陳述。本次電話會議中的每項前瞻性聲明都存在風險和不確定性，可能導致實際結果與這些聲明中所述的結果有重大差異。描述這些風險的更多資訊包含在我們 8 月 8 日發布的財務業績新聞稿中，以及我們向 SEC 提交的最新年度和季度報告的風險因素和管理層討論與分析部分。

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

接下來，我想介紹一下執行長約翰·巴特勒。

Thanks, Mercedes, and thanks, everyone, for joining us today. Since the Vafseo FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. And Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives, which are, first, driving prescriber demand; second, contracting effectively with dialysis organizations; and third, advancing plans to generate clinical data that could demonstrate potential additional benefits of Vafseo.

謝謝梅賽德斯，謝謝大家今天加入我們。自 3 月底 Vafseo FDA 批准以來，幾乎整個公司都在努力專注於其商業發布。尼克將很快向您介紹詳細信息，但重點是，自我們上次與您交談以來的四個星期內，我們在關鍵啟動計劃方面取得了重大進展，這些計劃首先推動了處方醫生的需求；其次，與透析組織有效簽訂合約；第三，推進產生臨床數據的計劃，這些數據可以證明 Vafseo 潛在的額外好處。

As recently announced, we filed our TDAP application in June and are now about five months away from making Vafseo available in the market. Our entire organization is incredibly energized by this upcoming event. We're encouraged by the strong reception to Vafseo from the medical community. The excitement around Vafseo was evident in two physician advisory boards we recently hosted.

正如最近宣布的，我們在 6 月提交了 TDAP 申請，距離 Vafseo 上市還有大約五個月的時間。我們整個組織都因這次即將舉行的活動而充滿活力。醫學界對 Vafseo 的強烈歡迎令我們深受鼓舞。我們最近主辦的兩個醫生諮詢委員會對 Vafseo 的興奮之情顯而易見。

What's especially interesting is that these are physicians we haven't worked with in the past and are new to the Vafseo story. The overwhelming response was that they're ready for a new choice in anemia management for dialysis patients. Our medical affairs team has been supporting dialysis organizations as they work to put Vafseo clinical protocols in place ahead of TDAPA.

特別有趣的是，這些醫生是我們過去沒有合作過的醫生，而且對 Vafseo 的故事還很陌生。壓倒性的反應是他們已經準備好為透析患者的貧血管理提供新的選擇。我們的醫療事務團隊一直在支持透析組織，努力在 TDAPA 之前製定 Vafseo 臨床方案。

Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data, including the vadadustat Phase 3 New England journal publications as well as the additional data we've generated to support health care providers' understanding and utilization of the product.

如今，我們擁有一整套積極從事醫師教育的 MSL，擁有豐富的臨床數據，包括 vadadustat 第 3 期新英格蘭期刊出版物以及我們為支持醫療保健提供者而產生的其他數據對產品的理解和使用。

Similarly, our commercial team has also been making good progress. Our field sales team is connecting with prescribers to drive awareness and demand. As we expand these discussions, physicians 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 ESAs. These are the segments where physicians attribute the greatest unmet need and they total more than 200,000 patients.

同樣，我們的商業團隊也取得了良好的進步。我們的現場銷售團隊正在與處方醫生聯繫，以提高意識和需求。當我們擴大這些討論時，醫生們對於最初期望使用該產品的地方非常一致。重點是家庭患者以及服用最高劑量 ESA 的患者。這些是醫生認為未滿足需求最多的細分市場，總共有超過 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. We're also very focused on the longer term growth for Vafseo. Generating new data to potentially expand the benefits of the product is critical. A key component of our strategy is to continue to generate this clinical data in collaboration with dialysis organizations.

我們相信，在獲得產品經驗並看到 Vafseo 對這些初始患者的好處後，處方者將將 Vafseo 的使用範圍擴大到這些患者群體之外。我們也非常關注 Vafseo 的長期成長。產生新數據以潛在地擴大產品的優勢至關重要。我們策略的關鍵組成部分是繼續與透析組織合作產生這些臨床數據。

We're deeply engaged with DOs in study design and believe these studies may meaningfully contribute to continued growth of Vafseo post TDAPA in the dialysis population. We need to continue to generate important clinical data for Vafseo to continue to move towards our goal of becoming a new standard of care.

我們與 DO 深入參與研究設計，並相信這些研究可能對 TDAPA 後 Vafseo 在透析人群中的持續成長做出有意義的貢獻。我們需要繼續為 Vafseo 產生重要的臨床數據，以繼續實現成為新護理標準的目標。

Think of it this way today, we're targeting the TDAPA patient population with a premium price. Once TDAPA ends in 2027 will have a price consistent with ESAs, full target the entire dialysis market over 500,000 patients and approximately $1 billion today. New data, along with the positive experience over the TDAPA period will be central to meeting our goal. The market for vascular and dialysis is significant, but let's also talk about potential expansion.

今天這樣想，我們以高價瞄準 TDAPA 患者族群。一旦 TDAPA 於 2027 年結束，價格將與 ESA 一致，全面瞄準整個透析市場，覆蓋超過 50 萬名患者，目前價值約 10 億美元。新數據以及 TDAPA 期間的積極經驗對於實現我們的目標至關重要。血管和透析市場很大，但我們也談談潛在的擴張。

Circling back to physician interest in Vafseo and unsurprising additional point continues to come up both in the advisory boards I mentioned earlier and in virtually every conversation we have with prescribers. Physicians see a clear and obvious unmet need in the treatment of anemia in CKD patients, not on dialysis. We agree. Accordingly, we've prioritized Vafseo label expansion for non-dialysis CKD patients. As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year.

回到醫生對 Vafseo 的興趣，在我之前提到的諮詢委員會以及我們與處方醫生的幾乎每一次對話中，繼續出現不足為奇的額外觀點。醫生發現，慢性腎臟病患者的貧血治療（而非透析）有明顯未被滿足的需求。我們同意。因此，我們優先考慮針對非透析 CKD 患者擴展 Vafseo 標籤。正如我們之前所說，我們預計將在今年年底之前提供有關該計劃的更詳細的最新資訊。

Now let me turn it over to Nic to talk about our commercial progress.

現在請Nic談談我們的商業進展。

Thanks, John, and thanks for those joining us on the call today. Our Vafseo launch activities continue to ramp and evolve, and we are making significant progress across all of our key initiatives, targeting both the high end makers as well as the doctors who are directly involved in patient care. The feedback we are getting on Vafseo has been positive and doctors are enthusiastic about using the drug to help their dialysis patients, especially in patients who receive in-home dialysis, patients on high dose of the [ESAIs] or patients not achieving appropriate hemoglobin levels.

謝謝約翰，也謝謝今天加入我們電話會議的人。我們的 Vafseo 發布活動不斷擴大和發展，我們的所有關鍵舉措都取得了重大進展，目標既包括高端製造商，也包括直接參與患者護理的醫生。我們從 Vafseo 獲得的回饋是正面的，醫生熱衷於使用該藥物來幫助透析患者，尤其是接受居家透析的患者、服用高劑量 [ESAI] 的患者或未達到適當血紅素水平的患者。

We're also making strong advances on the contracting front, where we are discussing our entire product portfolio, which strengthens our dialogue with dialysis organizations. We have had contract conversations with dialysis organizations covering nearly 90% of patient lives with many more to come in the next several months.

我們也在合約方面取得了重大進展，我們正在討論我們的整個產品組合，這加強了我們與透析組織的對話。我們已經與透析組織進行了合約對話，涵蓋了近 90% 的患者生命，並且在接下來的幾個月中還將進行更多對話。

I can tell you that dialysis organizations are looking for partners, partners who can help maximize the opportunity to incorporate innovative medications into their centers made possible by the TDAPA and also navigate the changes that are necessary considering the high likelihood that phosphate binders will be added to the bundle. Akebia has been and will be that partner. Our national accounts team has been busy and every day the pace is accelerating.

我可以告訴您，透析組織正在尋找合作夥伴，這些合作夥伴可以幫助最大限度地利用TDAPA 將創新藥物納入其中心的機會，並考慮到磷酸鹽結合劑很可能被添加到透析中心，從而引導必要的變革。木通一直是並將繼續成為這樣的合作夥伴。我們的國民帳團隊一直很忙碌，而且節奏每天都在加快。

We have also heard uniformly about high degree of chains associated with binders in the bundle. This change in reimbursement dynamics for phosphate binders could be associated with a change in distribution channels. And as a result, in the traditional inventory purchasing patterns for this category, including Auryxia. As such, dialysis organizations are reviewing their supply chain logistics to optimize their economics, both ahead of and during that TDAPA period. We're in the process of evaluating many new supply partners to minimize any disruption.

我們也一致聽說與束中的黏合劑相關的高度鏈。磷酸鹽結合劑報銷動態的這種變化可能與分銷管道的變化有關。因此，在該類別的傳統庫存採購模式中，包括 Auryxia。因此，透析組織正在審查其供應鏈物流，以在 TDAPA 之前和期間優化其經濟效益。我們正在評估許多新的供應合作夥伴，以盡量減少任何干擾。

That said, the change in distribution channel is not expected to impact overall demand for phosphate binders or Auryxia market share. And we therefore anticipate similar revenue trends in 2024 as compared to last year, though the supply chain could see some fluctuation as these changes roll out. We have leveraged Auryxia contracting discussions to simultaneously engage in Vafseo contracting. There is significant value to us as a company to have a portfolio of products promoted in the same space. And it allows for meaningful operational and potential financial benefits to be realized.

也就是說，分銷管道的變化預計不會影響磷酸鹽結合劑的整體需求或 Auryxia 市場份額。因此，我們預計 2024 年的收入趨勢將與去年類似，儘管隨著這些變化的推出，供應鏈可能會出現一些波動。我們利用 Auryxia 合約討論同時參與 Vafseo 合約。作為一家公司，在同一空間推廣一系列產品對我們來說具有重大價值。它可以實現有意義的營運和潛在的經濟效益。

The Vafseo wholesale acquisition cost of approximately $15,500 per patient per year has been well received by our customers and stakeholders operating in the tough environment who want to use assets. We expect our product supply contracts with dialysis organizations will include an off-invoice discount and a volume-based rebate. We also continue to work towards having all contracts complete by January.

Vafseo 的批發採購成本約為每位患者每年 15,500 美元，受到我們在惡劣環境中營運、想要使用資產的客戶和利害關係人的好評。我們預計我們與透析組織的產品供應合約將包括發票外折扣和基於數量的回扣。我們也將繼續努力在一月之前完成所有合約。

Before I turn it back to John, I wanted to quickly note progress from our international partner, Medice. Vafseo is now available in Germany and Austria, Medice just recently launched in the Netherlands. It is still early days for the European launch, but we are encouraged by our partners' enthusiasm and execution and their launch. John?

在我將其轉回約翰之前，我想快速介紹一下我們的國際合作夥伴 Medice 的進展。Vafseo 現已在德國和奧地利上市，Medice 最近剛在荷蘭上市。雖然在歐洲推出還處於初期階段，但我們對合作夥伴的熱情、執行力以及他們的推出感到鼓舞。約翰？

Thanks, Nick. And now I'd like to introduce you to Erik Ostrowski, who joined Akebia in June as our Chief Financial Officer and Chief Business Officer. Eric has an impressive track record in corporate finance and financial team leadership. His skill set is highly complementary to our executive leadership team and is already adding value to the business.

謝謝，尼克。現在我想向您介紹 Erik Ostrowski，他於 6 月加入 Akebia，擔任我們的財務長和商務長。艾瑞克（Eric）在企業財務和財務團隊領導方面擁有令人印象深刻的記錄。他的技能與我們的執行領導團隊高度互補，並且已經為公司增加了價值。

Eric, over to you to talk about our financial position.

艾瑞克，請您談談我們的財務狀況。

Thanks, John. I'm extremely pleased to join Akebia. I firmly believe this is a transformational time for the company. Now a month into the job, my conviction is strengthened. With the Vafseo product launch and established revenue generating business in Auryxia in a promising late-stage pipeline, I believe Akebia is well positioned for growth. And as importantly, I am happy to be working with a dedicated and hard-working team with such strong knowledge of and relationships in the renal space.

謝謝，約翰。我非常高興加入 Akebia。我堅信這是公司的轉型時期。現在工作一個月了，我的信念更堅定了。隨著 Vafseo 產品的推出以及在 Auryxia 在前景光明的後期管道中建立的創收業務，我相信 Akebia 已經做好了增長的準備。同樣重要的是，我很高興能與一支敬業、勤奮的團隊合作，他們在腎臟領域擁有如此豐富的知識和關係。

Now let's review the quarterly financials. Total revenue was $43.6 million in the second quarter of 2024. Of this amount, $41.2 million was derived from Auryxia net product revenue as compared to $42.2 million in Auryxia net product revenue during the second quarter of 2023. The remainder of our revenues during the quarter were derived from license collaboration and other revenues, which totaled $2.4 million as compared to $14.1 million in the second quarter of 2023. Of note, last year's second quarter licensing collaboration revenues included a one-time $10 million upfront payment related to our Medice licensing.

現在讓我們回顧一下季度財務數據。2024 年第二季總營收為 4,360 萬美元。其中，4,120 萬美元來自 Auryxia 淨產品收入，而 2023 年第二季 Auryxia 淨產品收入為 4,220 萬美元。本季的其餘收入來自授權合作和其他收入，總計 240 萬美元，而 2023 年第二季為 1,410 萬美元。值得注意的是，去年第二季的授權合作收入包括與 Medice 許可相關的一次性 1,000 萬美元預付款。

Cost of goods sold was $17 million in the second quarter of 2024 compared to $17.3 million in the second quarter of 2023. Akebia continues to carry a non-cash intangible amortization charge of $9 million per quarter in COGS through the fourth quarter of 2024. Research and development expenses were $7.6 million in the second quarter of 2024 compared to $20.2 million in the second quarter of 2023. This decrease was driven by the completion of certain clinical trial activities, a reduction in consulting expenses, and lower headcount related costs.

2024 年第二季的銷售成本為 1,700 萬美元，而 2023 年第二季為 1,730 萬美元。到 2024 年第四季度，Akebia 將繼續承擔每季 900 萬美元的非現金無形攤銷費用。2024 年第二季的研發費用為 760 萬美元，而 2023 年第二季的研發費用為 2,020 萬美元。這一下降是由於某些臨床試驗活動的完成、諮詢費用的減少以及人員相關成本的減少所致。

Selling, general, and administrative expenses were $26.9 million in the second quarter of 2024 compared to $27 million in the second quarter of 2023. And lastly, net loss was $8.6 million in the second quarter of 2024 compared to a net loss of $11.2 million in the second quarter of 2023. Cash and cash equivalents as of June 30, 2024 were $39.5 million, and I'm pleased to say we expect to have at least two years of cash runway. Our cash position continues to be supported by revenue from Auryxia and careful expense manage.

2024 年第二季的銷售、一般和管理費用為 2,690 萬美元，而 2023 年第二季為 2,700 萬美元。最後，2024 年第二季的淨虧損為 860 萬美元，而 2023 年第二季的淨虧損為 1,120 萬美元。截至 2024 年 6 月 30 日，現金和現金等價物為 3,950 萬美元，我很高興地說，我們預計至少有兩年的現金跑道。我們的現金狀況繼續得到 Auryxia 的收入和謹慎的費用管理的支持。

With that, we welcome questions.

因此，我們歡迎提問。

(Operator Instructions)

（操作員說明）

Julian Harrison, BTIG.

朱利安·哈里森，BTIG。

Thank you for my question and congrats on all the progress. Sorry if I missed it, but just want to confirm that it's still your expectation that you don't need to build out your sales force beyond what you already have for Auryxia and you probably don't need to manufacture additional API to meet initial demand for your Vafseo launch expected January next year?

感謝您提出問題並祝賀所有進展。抱歉，如果我錯過了，但只是想確認您仍然期望您不需要在 Auryxia 現有的基礎上建立銷售隊伍，並且您可能不需要製造額外的 API 來滿足初始需求您預計明年 1 月推出 Vafseo？

And so Nick, do you want to talk about sales force?

尼克，你想談談銷售人員嗎？

Absolutely. Julian, thanks for the question. Yes, we've had a team in place for our for the entire year that's already been calling on dialysis organizations and providers. While there may be some small tweaking around the edges, I don't think there's going to be anything that I would regard as significant or material in how we approach the marketplace from a headcount perspective.

絕對地。朱利安，謝謝你的提問。是的，我們已經組建了一個團隊，全年都在呼籲透析組織和提供者。雖然可能會有一些細微的調整，但我認為從員工數量的角度來看，我們進入市場的方式不會有任何我認為重要或實質的事情。

I think the bigger and change that we had was adding to the medical affairs group. We had skinnied down that group because medical affairs wasn't as impactful on Auryxia. But they're incredibly important for protocol development for the dialysis providers. So we did expand that group. As I said, they're -- it is fully staffed now and them and they're out there being very effective with physicians.

我認為我們最大的變化是增加了醫療事務小組。我們已經精簡了該小組，因為醫療事務對 Auryxia 的影響不大。但它們對於透析提供者的方案開發非常重要。所以我們確實擴大了這個群體。正如我所說，他們現在人員齊全，而且他們在醫生那裡非常有效。

And then your second question was around API, and that's correct, we have product in place. And Eric, maybe you want to kind of talk to that?

然後你的第二個問題是關於 API 的，這是正確的，我們已經有產品了。艾瑞克，也許你想談談這個？

Yeah, we do, we have projects in place, as discussed on prior calls, we do have -- it will be effectively zero cost inventory because it was previously expensed to R&D. And so yeah, just to reiterate, we're well positioned from an inventory perspective for the launch.

是的，我們確實有，我們有項目，正如之前電話中討論的那樣，我們確實有——這實際上將是零成本庫存，因為它之前已用於研發。所以，是的，重申一下，從庫存角度來看，我們為這次發布做好了準備。

Our quality team did a great job of generating data to expand the dating for the product. So everything we have on the shelf will -- that we had for two years ago for the launch we were expecting, we can use now and it's a great place to be in. Just from the perspective that you don't have significant cash outlay as for manufacturer. And but of course, you do like to manufacture some product and keep your CDMOs at current on the process. But it is helpful from a cash perspective.

我們的品質團隊在產生數據以擴展產品的日期方面做得非常出色。因此，我們貨架上的所有東西都將——兩年前我們期待的發佈時所擁有的一切，我們現在都可以使用，這是一個很棒的地方。只是從製造商沒有大量現金支出的角度來看。當然，您確實希望生產一些產品並讓您的 CDMO 掌握最新的流程。但從現金角度來看，這是有幫助的。

Okay, great. Thank you. And then one more, if I may. It's great to hear that you're engaging dialysis providers representing, I think you said 90% of the addressable market already. I'm wondering how much of that you expect to be enabled through your recently updated relationship with CSLV4?

好的，太好了。謝謝。如果可以的話，再來一張。很高興聽到您正在聘請透析提供者代表，我想您已經說過 90% 的目標市場。我想知道您希望透過最近更新的與 CSLV4 的關係實現多少目標？

No, it's a great question. It is frankly, we were already engaging with them around Auryxia. And if you remember, some of the catalysts for Auryxia was the proposed rule that came out around binders in the bundle, that help dialysis organizations really understand that it was coming, which was a catalyst for their urgency to meet with us earlier in the year. And really, the 90% is since the Vifor announcement we've met with them providers representing 90%, approximately 90% of the patients. So the Vifor catalyst becomes additional reasons for them to want to get us back in the room in order to discuss contracting and the process.

不，這是一個很好的問題。坦白說，我們已經在 Auryxia 周圍與他們進行了接觸。如果你還記得的話，Auryxia 的一些催化劑是圍繞捆綁包中的粘合劑提出的擬議規則，這有助於透析組織真正了解它即將到來，這也是他們在今年早些時候與我們會面的緊迫性的催化劑。事實上，這 90% 是自 Vifor 宣布以來我們與他們會面的供應商，代表了 90%，大約 90% 的患者。因此，Vifor 催化劑成為他們想讓我們回到房間討論合約和流程的額外原因。

Nick talked about us becoming a partner. I think we've considered ourselves a partner for some time, but when you have to contract directly with the dialysis providers, and now we're doing that on two products. And particularly, with phosphate binders, where there's going to be a lot of work for them to incorporate those into -- they're now purchasing the phosphate binder.

尼克談到我們成為合作夥伴。我認為我們已經將自己視為合作夥伴一段時間了，但是當你必須直接與透析提供者簽訂合約時，現在我們正在兩種產品上這樣做。特別是對於磷酸鹽結合劑，他們需要做很多工作才能將這些結合劑融入其中 - 他們現在正在購買磷酸鹽結合劑。

I mean managing that with their patients out of work in that. And they really want to work with companies as closely as possible on a lot of operational aspects, not just contractual aspects. And that's where -- it's one of those reasons why it's so powerful to have both products that we're talking to them about. It just increases the partnership between Akebia and dialysis providers on some really core areas of their business.

我的意思是在患者失業的情況下進行管理。他們確實希望在許多營運方面與公司盡可能密切合作，而不僅僅是合約方面。這就是我們正在與他們談論的這兩種產品如此強大的原因之一。它只是加強了 Akebia 和透析提供者之間在其業務的一些真正核心領域的合作夥伴關係。

The only thing I'll probably add to that is our history in dialysis allows those conversations to be one with a knowledge of their operational concerns, right? If you don't -- if you walk into these conversations without the knowledge of how they think about their business and what's important to them, it does become a conversation that can appear very one-sided and out for Akebia only and in a partnership, if they don't have an opportunity to be able to use the product successfully, then it's really not a partnership. And so creating that environment is really important.

我可能要補充的唯一一件事是我們在透析方面的歷史使得這些對話能夠成為了解其操作問題的對話，對嗎？如果你不這樣做——如果你在不了解他們如何看待自己的業務以及什麼對他們來說重要的情況下介入這些對話，那麼這確實會成為一場看起來非常片面的對話，並且只適合Akebia和合作夥伴，如果他們沒有機會能夠成功地使用該產品，那麼這真的不是合作夥伴關係。因此，創造這樣的環境非常重要。

We've been saying for years how important knowing the dialysis business is. Eric here for a month is learning how different and complicated and dialysis can be, and that is a real competitive advantage for us. Thanks for the questions, Julian.

多年來我們一直在強調了解透析業務的重要性。艾瑞克在這裡待了一個月，了解透析有多麼不同和複雜，這對我們來說是一個真正的競爭優勢。謝謝你的提問，朱利安。

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Hi, good morning. Thanks for taking my questions. Congrats on the progress towards the launch next year. Couple of questions for me first on the [VAT] price that you announced. Wondering if you could give a little details around some of the criteria as you thought through working to optimize the price, not only for TDAPA but afterwards and what sort of key aspects came into that thought process?

嗨，早安。感謝您回答我的問題。祝賀明年的發射取得進展。首先問我幾個關於你們宣布的[增值稅]價格的問題。想知道您在考慮優化價格時是否可以圍繞一些標準提供一些細節，不僅是針對 TDAPA，而且是在之後，以及在該思考過程中考慮了哪些關鍵方面？

Secondly, with Medice, wondering if you can disclose what proportion of the collaborative sales this quarter came from Germany, I think it was Germany and Australia, which launched in June. If there's any other further countries that you expect to come online between now and the end of the year? Thanks so much.

其次，Medice，想知道您是否可以透露本季的合作銷售中有多少比例來自德國，我認為是德國和澳大利亞，這是六月推出的。您預計從現在到今年年底還有其他國家上線嗎？非常感謝。

So Erik, you want to handle?

那麼埃里克，你想處理嗎？

That's a quick one, yes. So no revenues from the DC in this quarter, as you pointed out, that was (inaudible)

這是一個很快的，是的。因此，正如您所指出的，本季 DC 沒有收入（聽不清楚）

Yes, they just started. So we look forward to seeing that progress. I don't know if we have -- do you know any other countries you're expecting to?

是的，他們才剛開始。因此，我們期待看到這一進展。我不知道我們是否有——你知道你還希望去哪些其他國家嗎？

I know there's Netherlands, just VAT.

我知道有荷蘭，只是增值稅。

(multiple speakers) Some of the other Nordic countries already are in the balance of the year.

（多名發言者）其他一些北歐國家已經進入了今年的剩餘時間。

Yes. I mean, the larger countries that is where they have to do the price negotiation, which I think we'll start to see them come online next year. But the smaller countries like Netherlands and now the Nordic countries will come on sooner.

是的。我的意思是，較大的國家必須進行價格談判，我認為我們明年將開始看到它們上線。但像荷蘭和現在的北歐國家這樣的小國會更早出現。

Nick, you want to walk through the thought around VAT pricing?

尼克，您想了解一下有關增值稅定價的想法嗎？

Yes. So really VAT pricing coupled a couple of different things is when we thought about it as one, what price would allow for dialysis organizations to be successful during the TDAPA period. And so how do you set up your contract? What is the lag prices, your reimbursement for the first several quarters of TDAPA, and allowing to depot, which really supports innovative products being utilized that VAT price and then how do we make it a price that is mix, our dialysis organizations and Akebia successful was a consideration.

是的。因此，當我們將其視為一個整體時，增值稅定價實際上與幾個不同的因素相結合，即什麼價格可以讓透析組織在 TDAPA 期間取得成功。那你如何制定合約呢？滯後價格是多少，您對 TDAPA 前幾季的報銷以及允許倉庫，這確實支持使用增值稅價格的創新產品，然後我們如何使其成為混合價格，我們的透析組織和 Akebia 成功是一個考慮因素。

Two, how do we make sure we manage that price over the TDAPA periods. So that post TDAPA, when we talk about ESA like the pricing, we can manage ES-like pricing to make the product sustainable post TDAPA. Remember, it's a $1 billion market today at ESA pricing. And thereforem creating that predictability posted alpha that the dialysis organizations wanted is critically important.

第二，我們如何確保在 TDAPA 期間管理該價格。因此，在 TDAPA 後，當我們像定價一樣談論 ESA 時，我們可以管理類似 ES 的定價，以使產品在 TDAPA 後可持續發展。請記住，按照 ESA 定價，目前的市場價值為 10 億美元。因此，創造透析組織想要的可預測性阿爾法至關重要。

And then lastly, but importantly, the non-dialysis population. Less than 25% of patients today in the non-dialysis space our on anemia management product are being treated for their anemia. And when they enter into dialysis, the outcomes associated with folks that have been treated versus those not, is enormous. And some the value of having a product like Vafseo in the non-dialysis space is very, very high. And therefore, making sure we're pricing for that dynamic and that innovative value in that subset of population is important as well.

最後但也很重要的是非透析族群。目前，在非透析領域，我們的貧血管理產品中只有不到 25% 的患者正在接受貧血治療。當他們進入透析時，接受治療的人和未接受治療的人相比，結果是巨大的。在非透析領域擁有像 Vafseo 這樣的產品的價值非常非常高。因此，確保我們針對該族群的動態和創新價值進行定價也很重要。

Yes, I that last point is just can't be emphasized enough. And frankly, I think it really was a challenge balancing and what's right for the dialysis market today, versus what's possible and the benefit we would bring to the non-dialysis patient population. I hope we've struck the balance here. And particularly, as Nic pointed out, that whack reimbursement for the first few quarters of TDAPA is critical exists. And it is a real operational costs for the dialysis providers to add a new product to us and to put protocols in place, storage, et cetera, and they have to see the business rationale for them to do that. You also want to be very cognizant of the optics around kind of how pricing is viewed.

是的，我對最後一點的強調再怎麼強調也不為過。坦白說，我認為這確實是一個挑戰，平衡什麼對當今的透析市場是正確的，與什麼是可能的以及我們將為非透析患者群體帶來的好處。我希望我們已經在這裡取得了平衡。特別是，正如 Nic 指出的那樣，TDAPA 前幾季的巨額報銷至關重要。對於透析提供者來說，為我們添加新產品並落實方案、儲存等是真正的營運成本，他們必須了解這樣做的商業理由。您還需要非常了解如何看待定價的光學原理。

So it's quite the balance we have to strike. We did a lot -- had a lot of conversations folks from before making that decision. And as Nick pointed out in his remarks, I think we did hit the right balance for the dialysis population. Folks are reacting quite well and are very willing to contract and put the product as part of their formulary.

所以這是我們必須達到的平衡。在做出這個決定之前，我們做了很多事情——與人們進行了​​很多對話。正如尼克在演講中指出的那樣，我認為我們確實為透析人群達到了正確的平衡。人們的反應非常好，並且非常願意簽訂合約並將該產品作為其處方的一部分。

The only additional context I'll add, Ed, is I've been with a lot of customers over the last month. And as you go through the VAT price and to understand how to operationalize it, what it means in the context of the contract structure that we've talked about it off invoice discounts and volume-based rebates, which we've talked about, again, as volume goes up, their price goes down, which means their economics improve. They've looked at and said that, makes a lot of sense. That's what you really want from your customers is that that makes a lot of sense, that reinforcement that you've done the right thing for them, which is important.

艾德，我要補充的唯一額外背景是，上個月我與許多客戶打交道。當您了解增值稅價格並了解如何實施它時，它在我們已經討論過的發票折扣和基於數量的回扣的合約結構背景下意味著什麼，我們已經再次討論過這些，隨著數量的增加，他們的價格下降，這意味著他們的經濟狀況改善。他們看了之後說，很有道理。這就是你真正希望從客戶那裡得到的，那就是這很有意義，強化你為他們做了正確的事情，這很重要。

And it really creates an environment where physicians can drive (inaudible) As you said, you can have a great contract in place. But if you don't have physician demand, they're not going to force that. Our sales force is driving that demand. And we know that if physicians have access and are able to use it, which we create through the contracting that physicians will like using the product, they'll see the benefits of using the product, and they'll expand their use of the product, and that's what positions us well, even though post TDAPA, we're going to have to take this price cut, if you will. We're now going to be targeting the entire dialysis market and people will be open to that.

它確實創造了一個醫生可以開車的環境（聽不清楚）正如你所說，你可以簽訂一份很好的合約。但如果你沒有醫生的要求，他們就不會強迫你這麼做。我們的銷售團隊正在推動這項需求。我們知道，如果醫生能夠訪問並能夠使用它（我們透過合約創建了醫生會喜歡使用該產品），他們就會看到使用該產品的好處，並且會擴大該產品的使用範圍，這就是我們的有利位置，即使在TDAPA 之後，我們也將不得不接受這次降價，如果你願意的話。我們現在將瞄準整個透析市場，人們對此持開放態度。

And that's a $1 billion market today. So that's a significant opportunity. And then hopefully, as shortly as possible thereafter, we introduce the product into the non-dialysis market with a label in non-dialysis, and then you'll start to have patients starting dialysis on Vafseo. So this is how you become standard of care. It's a process first step in dialysis is you've got to have that contract in place that allows physicians to access the product. And that VAT Pricing decision was very, very central to that, to making that possible.

如今，這是一個價值 10 億美元的市場。所以這是一個重要的機會。希望此後盡快將該產品引入非透析市場，並貼上非透析標籤，然後您將開始讓患者開始使用 Vafseo 進行透析。這就是您成為標準護理的方式。這是透析過程的第一步，您必須簽訂允許醫生使用產品的合約。增值稅定價決定對於實現這一目標至關重要。

Very helpful. Thanks so much.

非常有幫助。非常感謝。

Thanks, Ed.

謝謝，艾德。

Thank you. There are no questions. I will now turn the conference back over to John Butler, CEO, for closing remarks.

謝謝。沒有問題。現在我將把會議轉回執行長約翰巴特勒 (John Butler) 致閉幕詞。

Thanks, Andrea. We remain extremely energized by our contracting process and the upcoming Vafseo market availability, which is now only a few months away. We're on target with all of our internal time lines and believe we will have all the pieces in place for a successful launch. I really look forward to seeing many of you at the fall investor conferences and hopefully at the ASN Kidney Week in October.

謝謝，安德里亞。我們對合約流程和即將推出的 Vafseo 市場仍然充滿活力，距離現在只有幾個月的時間了。我們的所有內部時間表都達到了目標，並相信我們將準備好成功發布的所有部件。我真的很期待在秋季投資者會議上見到你們，並希望能在 10 月的 ASN 腎臟週上見到你們。

Thanks, everyone, enjoy the rest of your summer.

謝謝大家，祝大家暑假愉快。

Thank you. Ladies and gentlemen, that concludes today's call and thank you all for joining You may now disconnect.

謝謝。女士們先生們，今天的電話會議到此結束，感謝大家的加入。