Akebia Therapeutics Inc (AKBA) 2022 Q4 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by, and welcome to Akebia's Fourth Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

女士們先生們，美好的一天。感謝您的支持，歡迎來到 Akebia 2022 年第四季度財務業績電話會議。 （操作員說明）請注意，今天的會議正在錄製中。我現在將把會議交給您的演講主持人，企業傳播高級總監梅賽德斯卡拉斯科。請繼續。

Thank you, and welcome to Akebia's Fourth Quarter and Full Year 2022 Financial Results and Business Update Conference Call. Today, we also celebrate World Kidney Day, an opportunity to raise awareness for kidney health and recognize all those in the kidney community who share in our purpose to better the lives of people impacted by kidney disease. Joining me for today's call, we have John Butler, Chief Executive Officer; and Dave Spellman, Chief Financial Officer. A press release was issued earlier today, Thursday, March 9, detailing our fourth quarter and full year 2022 financial results, and that release is available on the Investors section of our website.

謝謝，歡迎來到 Akebia 的第四季度和 2022 年全年財務業績和業務更新電話會議。今天，我們還慶祝世界腎臟日，這是一個提高腎臟健康意識的機會，並表彰腎臟界所有與我們有共同目標的人，即改善受腎臟疾病影響的人們的生活。與我一起參加今天的電話會議的有首席執行官 John Butler；首席財務官 Dave Spellman。今天（3 月 9 日，星期四）早些時候發布了一份新聞稿，詳細介紹了我們第四季度和 2022 年全年的財務業績，該新聞稿可在我們網站的投資者部分獲取。

For your convenience, a replay of today's call will also be available on our website after we conclude. Before we begin, 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.

為了您的方便，今天電話會議的重播也將在我們結束後在我們的網站上提供。在開始之前，我想提醒大家，本次電話會議包含前瞻性陳述。本次電話會議的每項前瞻性陳述都存在風險和不確定性，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存在重大差異。

Additionally, information describing these risks is included in the financial results press release that we issued on March 9 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. The forward-looking statements on this call speak only to the original date of this call, and except as required by law, we do not undertake any obligation to update or revise any of these statements. With that, I'd like to introduce our CEO, John Butler.

此外，描述這些風險的信息包含在我們 3 月 9 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的風險因素和管理層討論與分析部分。本次電話會議的前瞻性陳述僅針對本次電話會議的原始日期，除法律要求外，我們不承擔任何更新或修改這些陳述的義務。至此，我想介紹一下我們的首席執行官約翰巴特勒。

Thanks, Mercedes, and thank you all for joining us. Everyone at Akebia has entered 2023 with renewed optimism. Through the past year, our team's work and the strategic decisions we've made have put us in a position to thrive as a company. We continue to engage with the kidney community and support our patients on Auryxia. We've advanced the regulatory process for vadadustat in Europe to a point where we're now approaching a potential marketing authorization, and we're excited to look ahead as we evaluate and drive potential pipeline expansion opportunities, including developing hypoxia-inducible factor prolyl hydroxylase inhibitor compounds for potential indications of serious unmet need.

謝謝梅賽德斯，感謝大家加入我們。 Akebia 的每個人都以新的樂觀態度進入 2023 年。在過去的一年裡，我們團隊的工作和我們做出的戰略決策使我們能夠作為一家公司蓬勃發展。我們繼續與腎臟社區合作，並在 Auryxia 上為我們的患者提供支持。我們已經推進了歐洲 vadadustat 的監管程序，我們現在正在接近潛在的營銷授權，我們很高興展望未來，因為我們評估和推動潛在的管道擴張機會，包括開發缺氧誘導因子脯氨酰用於嚴重未滿足需求的潛在適應症的羥化酶抑製劑化合物。

We have a team that works with purpose, and I'm proud of their accomplishments as they've delivered a company today with a strong revenue base, multiple near-term catalysts and mid- and long-term product development opportunities. Now let's begin with Auryxia. In 2022, we reported net product revenue growth of nearly 25% over 2021, exceeding the revenue target guidance we established midyear.

我們有一個有目標的團隊，我為他們的成就感到自豪，因為他們今天交付了一家擁有強大收入基礎、多種近期催化劑和中長期產品開發機會的公司。現在讓我們從 Auryxia 開始。 2022 年，我們報告的淨產品收入比 2021 年增長近 25%，超過了我們在年中製定的收入目標指引。

Achieving net product revenue growth, while the phosphate binder market continued to decline, is a credit to our dedicated commercial team that works hard to ensure thousands of patients have access to Auryxia. Last year, we launched a new commercial model that aligns to customer objectives. We believe the model will enable our team to continue high-touch engagement with high-value individual prescribers and entities that are focused on delivering coordinated, cost-effective care for advanced CKD patients, including those receiving dialysis.

在磷酸鹽結合劑市場持續下滑的同時實現產品淨收入增長，這要歸功於我們敬業的商業團隊，他們努力工作以確保成千上萬的患者能夠使用 Auryxia 。去年，我們推出了一種符合客戶目標的新商業模式。我們相信，該模型將使我們的團隊能夠繼續與高價值的個體處方者和實體保持密切接觸，這些處方者和實體專注於為晚期 CKD 患者（包括接受透析的患者）提供協調、具有成本效益的護理。

Auryxia net product revenue is integral to our operating plan as we continue to support the regulatory processes for vadadustat globally and invest in our other drug research and development activities. Regarding vadadustat, we're quickly approaching a potential milestone. In late February, the Committee for Medicinal Products for Human Use, or CHMP, of the EMA adopted a positive opinion recommending that the European Commission approve Vafseo, vadadustat for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis.

Auryxia 淨產品收入是我們運營計劃不可或缺的一部分，因為我們繼續支持全球 vadadustat 的監管流程，並投資於我們的其他藥物研發活動。關於 vadadustat，我們正在快速接近一個潛在的里程碑。 2 月下旬，EMA 人用藥品委員會 (CHMP) 採納了一項積極意見，建議歐盟委員會批准 Vafseo，vadadustat 用於治療接受慢性維持性透析的成人 CKD 相關症狀性貧血。

We anticipate a potential marketing authorization for Vafseo to be granted by the EC in May of this year, which would be applicable to all 30 European Union member states and affiliated countries. Beyond the EU, we also anticipate a regulatory decision for vadadustat for ACCESS Consortium countries, the U.K., Switzerland and Australia later this year.

我們預計 EC 將於今年 5 月授予 Vafseo 潛在的營銷授權，這將適用於所有 30 個歐盟成員國和附屬國家。在歐盟之外，我們還預計今年晚些時候 ACCESS 聯盟國家、英國、瑞士和澳大利亞將對 vadadustat 做出監管決定。

We are dedicated to delivering an oral treatment option to patients with anemia due to chronic kidney disease and continue our efforts to select a potential partner in Europe to commercialize Vafseo if approved. We don't expect to formalize a partner engagement until sometime after Vafseo receives marketing authorization, but we're deeply engaged in the process to select a partner that can maximize the potential value of Vafseo while quickly reaching appropriate patients.

我們致力於為慢性腎病引起的貧血患者提供口服治療選擇，並繼續努力在歐洲選擇潛在的合作夥伴，如果獲得批准，將 Vafseo 商業化。在 Vafseo 獲得營銷授權後的某個時候，我們預計不會正式確定合作夥伴關係，但我們正在深入參與選擇合作夥伴的過程，以最大限度地發揮 Vafseo 的潛在價值，同時快速接觸到合適的患者。

A Vafseo marketing authorization in Europe would mean vadadustat would be approved in 31 countries as it's currently approved and marketed in Japan by MTPC for dialysis-dependent and non-dialysis-dependent adult patients. We believe in the favorable benefit risk profile of vadadustat. And to that end, we continue to pursue a potential path for approval in the U.S. for patients on dialysis.

Vafseo 在歐洲的上市許可意味著 vadadustat 將在 31 個國家獲得批准，因為它目前已由 MTPC 在日本批准和銷售，用於透析依賴和非透析依賴的成年患者。我們相信 vadadustat 有利的收益風險狀況。為此，我們繼續尋求在美國批准透析患者的潛在途徑。

Last year, we submitted a formal dispute resolution request with the FDA regarding the complete response letter for vadadustat, specifically related to adult patients on dialysis. In February of '23, we received the second interim response from the FDA indicating that due to agency resource constraints and staffing needs, Dr. Peter Stein, the Director of the Office of New Drugs or OND will serve as the deciding authority for the appeal.

去年，我們向 FDA 提交了一份正式的爭議解決請求，涉及 vadadustat 的完整回复函，特別是與接受透析的成年患者有關。 23 年 2 月，我們收到了 FDA 的第二次臨時答复，表明由於機構資源限制和人員配備需要，新藥辦公室主任或 OND 主任 Peter Stein 博士將擔任上訴的決定機構.

Dr. Stein has indicated he will seek internal consultation with nephrology, cardiology and liver safety experts in the OND to complete the review, and we expect to receive a response 30 days from when Dr. Stein completes his discussions. We continue to engage with Dr. Stein and the OND and we'll update investors on this process as appropriate. Now vadadustat is also being evaluated for other indications, notably acute respiratory distress syndrome or ARDS.

Stein 博士表示，他將與 OND 的腎髒病學、心髒病學和肝臟安全專家進行內部磋商以完成審查，我們預計將在 Stein 博士完成討論後 30 天內收到答复。我們將繼續與 Stein 博士和 OND 接觸，我們將酌情向投資者通報這一過程的最新情況。現在，vadadustat 也正在接受其他適應症的評估，特別是急性呼吸窘迫綜合徵或 ARDS。

Last year, we shared data from an investigator-sponsored clinical study with UT Health, evaluating vadadustat for the prevention and treatment of ARDS in patients with COVID-19 and hypoxia. Since that time, we've continued to work with UT Health to plan an adequate well-controlled study in a broad patient population beyond COVID-related ARDS in an acute setting, and we expect that study to begin enrolling patients this year.

去年，我們與 UT Health 共享了一項由研究者發起的臨床研究數據，評估了 vadadustat 在 COVID-19 和缺氧患者中預防和治療 ARDS 的效果。從那時起，我們一直與 UT Health 合作，計劃在急性環境中對 COVID 相關 ARDS 以外的廣泛患者群體進行充分的良好對照研究，我們預計該研究將於今年開始招募患者。

Within our 4 walls, we have the expertise to innovate and develop medicines to address patients' unmet needs. Further, our commercial team continues to keep us connected to patients while also enabling a product revenue stream to fund operations and pipeline expansion. To that end, we're also actively assessing regulatory and development paths for vadadustat in other acute treatment indications.

在我們的四壁之內，我們擁有創新和開發藥物以滿足患者未滿足需求的專業知識。此外，我們的商業團隊繼續讓我們與患者保持聯繫，同時也使產品收入流能夠為運營和管道擴張提供資金。為此，我們還在積極評估 vadadustat 在其他急性治療適應症中的監管和發展路徑。

This year, we also plan to advance preclinical development of multiple novel HIF-PHI compounds for serious disease areas with limited or no treatment options, such as acute kidney injury. Our patient focus drives us thoughtfully to invest in new programs to expand our pipeline. We're eager to do that as we look forward into 2023 and beyond.

今年，我們還計劃推進多種新型 HIF-PHI 化合物的臨床前開發，用於治療選擇有限或沒有治療選擇的嚴重疾病領域，例如急性腎損傷。我們對患者的關注促使我們深思熟慮地投資於新項目以擴大我們的渠道。展望 2023 年及以後，我們渴望做到這一點。

Again, we're able to do this because of the financial base we've strengthened through the past year. And to that end, I'll ask Dave to talk more about our operating plan and our financials.

同樣，我們之所以能夠做到這一點，是因為我們在過去一年中加強了財務基礎。為此，我會請戴夫更多地談談我們的運營計劃和財務狀況。

Thank you, John, and good morning, everyone. 2022 was an important year for Akebia, and we have developed an operating plan that will enable us to further build value as we capitalize on potential upcoming catalysts in 2023. Most immediately, assuming vadadustat gets approved by the EMA in May, we will have developed a second drug that will be approved in over 30 countries and has the potential to benefit thousands of patients.

謝謝約翰，大家早上好。 2022 年對 Akebia 來說是重要的一年，我們制定了一項運營計劃，使我們能夠在利用 2023 年即將到來的潛在催化劑時進一步創造價值。最直接的是，假設 vadadustat 在 5 月獲得 EMA 批准，我們將開發第二種藥物將在 30 多個國家/地區獲得批准，並有可能使成千上萬的患者受益。

Beyond the European approval for vadadustat, we could initiate our next ARDS study with UT Health in a non-COVID ARDS population, generate preclinical data for indications for vadadustat in acute settings, secure a potential approval for vadadustat in other countries, including the U.K., Switzerland and Australia, secure an ex U.S. licensing deal, resolve our FDRR process with the FDA, which would provide clarity to our expense profile and the potential revenue related to vadadustat in the U.S.

除了歐洲對 vadadustat 的批准外，我們還可以在非 COVID ARDS 人群中啟動我們與 UT Health 的下一個 ARDS 研究，為急性環境中 vadadustat 的適應症生成臨床前數據，確保 vadadustat 在其他國家（包括英國）的潛在批准，瑞士和澳大利亞獲得前美國許可協議，解決我們與 FDA 的 FDRR 流程，這將使我們的費用概況和與美國 vadadustat 相關的潛在收入變得清晰。

Beyond vadadustat, broader portfolio opportunities that may be added within our operating plan include potential to leverage our infrastructure, to build out our development and commercial portfolio with new external assets and maturation of our preclinical programs with the potential for multiple INDs over the coming years.

除了 vadadustat 之外，我們的運營計劃中可能會增加更廣泛的投資組合機會，包括利用我們的基礎設施的潛力，利用新的外部資產構建我們的開發和商業投資組合，以及我們的臨床前項目的成熟，並有可能在未來幾年內實現多個 IND。

Auryxia continues to perform well, which based on our guidance for 2023, will deliver net revenues in excess of $350 million over the 2022, 2023 time period. Our Auryxia guidance of $175 million to $180 million assumes inventories return to normal levels and that we realized an increase in net price per pill partially offset by a reduction in total units sold.

Auryxia 繼續表現良好，根據我們對 2023 年的指導，它將在 2022 年、2023 年期間實現超過 3.5 億美元的淨收入。我們 1.75 億美元至 1.8 億美元的 Auryxia 指導假設庫存恢復到正常水平，並且我們意識到每顆藥丸淨價的上漲部分被銷售總量的減少所抵消。

We also assume that the binder market continues to have challenges. Our cost management exercise has yielded important financial strength and stability for us. We expect to have cleared the going concern analysis upon filing of our 10-K, meaning that we have cash that will provide us the resources to fund our operating plan for at least 12 months.

我們還假設粘合劑市場繼續面臨挑戰。我們的成本管理活動為我們帶來了重要的財務實力和穩定性。我們希望在提交 10-K 時清除持續經營分析，這意味著我們擁有現金，可以為我們的運營計劃提供至少 12 個月的資金。

This is the result of 2 main focuses of the company which we have previously discussed in great detail, but given the significance of the event is worth reviewing again. First and most obvious is the commercial success that led to a nearly 25% increase in year-over-year net product revenue for Auryxia. Our commercial leadership team undertook a laborious process to look at each and every commercial contract and position the brand to deliver more revenue on fewer net tabs sold.

這是我們之前詳細討論過的公司 2 個主要關注點的結果，但鑑於該事件的重要性值得再次回顧。首先也是最明顯的是商業上的成功，使 Auryxia 的產品淨收入同比增長近 25%。我們的商業領導團隊進行了一項艱鉅的過程，以查看每一份商業合同，並定位品牌以通過售出更少的淨標籤來提供更多收入。

A few products achieved this type of growth, let alone those that are in their [APR] on the market. Many congrats are owed to our commercial team, including our key account managers. Second and just as important has been the narrowing of our strategic focus, which has enabled concentrated spend on items that will support our future growth.

一些產品實現了這種類型的增長，更不用說那些在市場上 [APR] 的產品了。許多祝賀都歸功於我們的商業團隊，包括我們的主要客戶經理。其次，同樣重要的是縮小了我們的戰略重點，這使得我們能夠將支出集中在支持我們未來增長的項目上。

We have exited several contracts that were not yielding the return we needed and have asked our people to do more with less and have stopped certain activities in order to push more money into our R&D pipeline. In addition, we reduced our debt balance and are paying less interest expense than otherwise would have. Overall, we are managing our working capital tightly.

我們已經退出了幾份沒有產生我們所需回報的合同，並要求我們的員工事半功倍，並停止了某些活動，以便將更多資金投入我們的研發渠道。此外，我們減少了債務餘額，支付的利息費用也比其他方式少。總體而言，我們正在嚴格管理營運資金。

We are not offering operating expense guidance at this time, but we'll continue to focus on extending our cash runway. Our focus on maximizing Auryxia revenue remains both pre and post LOE, and we will only look to reinvest in high-value areas we can afford to pursue. We will also look for areas to potentially grow our revenues with Auryxia, for example, by ensuring that we have a TDAPA strategy in place to maximize revenue during this period as well as potentially having revenue from vadadustat first with a European partnership.

我們目前不提供運營費用指導，但我們將繼續專注於擴大我們的現金跑道。我們對最大化 Auryxia 收入的關注仍然是在 LOE 之前和之後，我們只會尋求在我們能夠負擔得起的高價值領域進行再投資。我們還將尋找可能通過 Auryxia 增加收入的領域，例如，通過確保我們制定 TDAPA 戰略以在此期間最大化收入，以及可能首先通過歐洲合作夥伴關係從 vadadustat 獲得收入。

On that note, as you are all aware, we recently obtained a positive opinion for vadadustat from the CHMP and now anticipate a potential approval in May. As John mentioned, we have been actively pursuing a partnership to ensure a successful launch in a timely manner. We cannot, at this time, provide guidance on deal economics, but can say we are looking for a partner who will team with us to maximize the value of the asset and shares our goal of benefiting as many patients as possible within the approved indication.

關於這一點，眾所周知，我們最近從 CHMP 那裡獲得了對 vadadustat 的積極意見，現在預計可能會在 5 月份獲得批准。正如約翰所說，我們一直在積極尋求合作夥伴關係，以確保及時成功發布。目前，我們無法提供交易經濟學方面的指導，但可以說我們正在尋找一個合作夥伴，他將與我們合作以最大限度地提高資產價值，並分享我們的目標，即在批准的適應症範圍內使盡可能多的患者受益。

Finally, pivot into NASDAQ compliance. We have filed our definitive proxy and are on track to take the appropriate steps to regain compliance with the price criteria for continued listing on NASDAQ. On today's call, we will not be going through year-over-year fluxes of the financials beyond those provided in the press release, but are happy to dive into questions. With that, we'll open the line to questions. Operator?

最後，轉向納斯達克合規性。我們已經提交了最終委託書，並有望採取適當措施重新遵守繼續在納斯達克上市的價格標準。在今天的電話會議上，我們不會討論新聞稿中提供的財務數據的逐年變化，但很樂意深入探討問題。有了這個，我們將打開問題的熱線。操作員？

(Operator Instructions) And our first question coming from the line of Allison Bratzel with Piper Sandler.

（操作員說明）我們的第一個問題來自 Allison Bratzel 和 Piper Sandler。

So first, just one on the vadadustat appeal process. Could you just help us understand if you've had any additional communications with FDA since the interim response in late February? And just hoping you could walk us through the possible outcomes and expected kind of cadence of events there. Do you plan to communicate when the 30-day clock starts for Dr. Stein's review? And then I have a couple of follow-up questions after that.

首先，我只想談談 vadadustat 上訴流程。您能否幫助我們了解自 2 月下旬的臨時答復以來您是否與 FDA 進行了任何其他溝通？只是希望你能帶我們了解可能的結果和預期的事件節奏。您是否計劃在 Stein 博士審查的 30 天時鐘開始時進行溝通？然後我有幾個後續問題。

Sure. Thanks, Ally. So we are in regular conversation with the agency, usually administrative more than anything else. And again, just to stress, we don't understand -- we can't say what exactly the timing of this is going to be. It will be 30 days after he's finished his internal review. He has clearly communicated that he's looking to do that in an efficient manner. Exactly what that means, we can't say.

當然。謝謝，艾莉。因此，我們與該機構進行定期對話，通常是行政對話，而不是其他任何事情。再次強調，我們不明白——我們不能說出具體的時間安排。他完成內部審查後還有 30 天。他已經明確表示他希望以一種有效的方式做到這一點。這究竟意味著什麼，我們不能說。

So I can't guide you towards when that might be. But it seemed clear in the letter that there's not an expectation of dragging that review out. But I don't want to set an expectation that we can't meet because it takes a while longer to complete those conversations. But there is a regular kind of administrative communication through the process.

所以我無法引導你走向可能的時間。但信中似乎很清楚，沒有人期望拖延審查。但我不想設定一個我們無法滿足的期望，因為完成這些對話需要更長的時間。但是在這個過程中有一種常規的行政溝通。

There isn't a commitment that we'll know exactly when that 30-day clock will start, so it's hard to say. We will definitively tell you when it does. But as I said, we will clearly update as appropriate as we understand the process going forward without getting into that kind of -- that day-to-day communication. And so I think you asked about potential outcomes. And so there's a number of potential outcomes.

沒有承諾我們會確切知道 30 天的時鐘何時開始，所以很難說。我們會明確地告訴你什麼時候發生。但正如我所說，我們將根據我們對未來流程的了解，在不進行那種日常溝通的情況下進行適當的更新。所以我想你問過潛在的結果。因此，有許多潛在的結果。

There's the outcome of an appeal being denied and just being referred back to the CRL and then back to the division to talk about what a path forward would be. There is -- and a very common one is an appeal denied but identifying a path forward. This is not -- that's similar to what happened with tenapanor and Ardelyx, right? There was -- the appeal was denied, but there was an AdCom for the product that ultimately, I think, they're very much on a path for an approval now.

上訴被拒絕的結果只是被轉回 CRL，然後回到部門討論前進的道路。有 - 一個非常常見的是上訴被拒絕但確定了前進的道路。這不是——這類似於 tenapanor 和 Ardelyx 發生的事情，對吧？有 - 上訴被拒絕，但有一個產品的 AdCom，最終，我認為，他們現在非常希望獲得批准。

So that's quite common where they will deny the appeal, but give you a path that ultimately leads to an approval. And then there's the appeal granted in which case you are then going to refile your NDA and it could be a 2-month review clock or a 6-month review clock, that's part of the communication, but then you're kind of on the road to an approval based on a review of our NDA. So I think those are that kind of the universe of what we might hear. Within that appeal denied but a path forward, there's -- we don't know what other kind of things might come up from there, but I think there's a limited number of things like an Adcom. Do you have something else for that -- yes, that's it.

所以這很常見，他們會拒絕上訴，但會為您提供最終獲得批准的途徑。然後是批准的上訴，在這種情況下，您將重新提交您的 NDA，它可能是 2 個月的審查時鐘或 6 個月的審查時鐘，這是溝通的一部分，但你有點在基於對我們的 NDA 的審查獲得批准的道路。所以我認為這些就是我們可能聽到的那種宇宙。在那個被拒絕的上訴中，有一條前進的道路，有——我們不知道從那裡可能會出現什麼其他類型的事情，但我認為像 Adcom 這樣的事情數量有限。你還有別的東西嗎 - 是的，就是這樣。

You say you have follow-up questions?

你說你有後續問題？

Yes. No, that's helpful. Another question I wanted to ask about the daprodustat approval. Just hoping you could kind of share your thoughts on how that approval and also now that the FDA review documents have been published. Just how does that impact your thinking about the chances for a successful appeal outcome for vadadustat.

是的。不，那很有幫助。我想問的另一個問題是關於 daprodustat 的批准。只是希望您能分享您對批准的方式以及現在 FDA 審查文件已經發布的看法。這將如何影響您對 vadadustat 成功上訴結果的可能性的思考。

And also just for the potential vadadustat-label just noticing that the TDAPA label is specifically indicated for patients on dialysis for at least 4 months. Is that -- is it your sense that, that would reflect class labeling? Or is that more something specific to that produce that and understanding this might be a cart before the horse question, but just interested in your thoughts...

並且還只是針對潛在的 vadadustat 標籤，只是注意到 TDAPA 標籤專門針對透析至少 4 個月的患者。那是——你認為這會反映階級標籤嗎？或者是更多特定於產生的東西並理解這可能是本末倒置的問題，但只是對你的想法感興趣......

Yes. That's where I was going to start, Ally, I mean it'd be fantastic to be having that conversation with the FDA about what the label looks like. So of course, we haven't had that yet. So don't know -- I couldn't comment at all on what might be considered class labeling versus not. I mean I think there's no question that the FDA approving daprodustat, approving drug in the HIF-PHI class is a positive signal that they are willing to make products available from the class.

是的。這就是我要開始的地方，Ally，我的意思是與 FDA 就標籤的外觀進行對話真是太棒了。所以當然，我們還沒有。所以不知道——我根本無法評論什麼可以被認為是類標籤，什麼不是。我的意思是，我認為毫無疑問，FDA 批准 daprodustat，批准 HIF-PHI 類藥物是一個積極的信號，表明他們願意提供該類產品。

So I think that's -- there's no way to read that in a negative way from my perspective. Every product is an individual product, though, right? And -- so how our -- what our label might look like vis-a-vis there is impossible to predict what that would be now. Like I said, I can't wait to be in -- in those labeling discussions with the FDA. And we just do not know kind of what will come from the FDRR.

所以我認為那是——從我的角度來看，沒有辦法以消極的方式解讀它。但是，每個產品都是單獨的產品，對嗎？而且 - 那麼我們的 - 我們的標籤可能看起來像什麼 無法預測現在會是什麼。就像我說的，我迫不及待地想參與與 FDA 的標籤討論。我們只是不知道 FDRR 會帶來什麼。

But we continue to have a lot of confidence in the data, a European CHMP positive opinion. I think similarly, is nothing but a positive for kind of -- for the FDA as Dr. Stein looks at the label. 31 countries have now decided that the product is safe and effective. So -- but we'll all -- we'll do everything we can on our end to move the process effectively. And again, we'll communicate it as quickly as we can.

但我們繼續對數據充滿信心，這是歐洲 CHMP 的積極意見。我認為類似地，對於斯坦因博士查看標籤時的 FDA 來說，這不過是一種積極的態度。現已有 31 個國家認定該產品安全有效。所以——但我們都會——我們將竭盡所能有效地推動這一進程。同樣，我們會盡快傳達它。

Okay. Yes. Understood. And then maybe just a last question for me, just on the expense trajectory. I guess this came up a bit in the prepared remarks, but just wondering if there's any color you can provide to help us understand that expense trajectory for both R&D and SG&A and just expectations for cash burn over the course of '23? Or is that something you'll be able to describe more once you do get that answer from FDA?

好的。是的。明白了。然後也許只是我的最後一個問題，只是關於費用軌跡。我想這在準備好的評論中出現了一點，但只是想知道您是否可以提供任何顏色來幫助我們了解研發和 SG&A 的支出軌跡以及對 23 年期間現金消耗的預期？或者一旦你從 FDA 得到答案，你就可以描述更多？

Yes. So Ally, thanks for the question. So like I said in the prepared remarks, we're not going to provide the specific guidance, but we have done a lot of work to continue to bring down R&D and SG&A, and we continue to do so even this quarter. A lot of that focus is bring it down so that we can balance the Auryxia revenue and revenue growth with reinvesting in these pipeline opportunities.

是的。艾莉，謝謝你的提問。所以就像我在準備好的評論中所說的那樣，我們不會提供具體的指導，但我們已經做了很多工作來繼續減少研發和 SG&A，即使在本季度我們也會繼續這樣做。很多重點是降低它，以便我們可以通過對這些管道機會的再投資來平衡 Auryxia 的收入和收入增長。

I think the big thing I mentioned, the expectation to clear the going concern analysis that is our -- that's the strongest guidance that we can give that we plan to be able to manage our expenses within the cash that we have and the Auryxia revenue. So we're very excited about that. And I think long term, the 2 things that would just factor into the burn would be success in the pipeline. And to your point, vadadustat investment in a commercial launch is not something that we've got in our plan right now.

我認為我提到的一件大事，即清除我們的持續經營分析的期望——這是我們可以提供的最強有力的指導，我們計劃能夠在我們擁有的現金和 Auryxia 收入範圍內管理我們的開支。所以我們對此感到非常興奮。而且我認為從長遠來看，僅會影響燃燒的兩件事將在管道中取得成功。就您的觀點而言，vadadustat 對商業發布的投資並不是我們目前計劃中的內容。

So if we are fortunate enough to be having those conversations, we would definitely be reassessing the investment plan. But again, this is where going back to something we have been talking about for a long time, our leverage and our commercial expertise -- the model that we have right now, the focus on the dialysis center is -- so the relationship in the dialysis center is so strong and the relationship with Vifor to be able to partner with them on that potential launch, we don't expect that this is a major, major new investment. We -- leverage is going to be the name of the game there.

因此，如果我們有幸進行這些對話，我們肯定會重新評估投資計劃。但是，這又回到了我們已經討論了很長時間的事情，我們的影響力和我們的商業專長——我們現在擁有的模式，重點是透析中心——所以關係透析中心是如此強大，並且與 Vifor 的關係能夠與他們合作進行潛在的發射，我們不認為這是一項重大的新投資。我們 - 槓桿將成為那裡游戲的名稱。

Yes. Such an important point. I mean when we made the change to the commercial structure, it was with the thought of vadadustat launch in mind as well. And with the Vifor partnership, I mean that would be incredible leverage we get out of that organization. Yes, there is investment to be made in a launch. But in this case, it's not -- it's a very small investment in people, a couple of marketing people maybe.

是的。這麼重要的一點。我的意思是，當我們對商業結構進行更改時，也考慮到了 vadadustat 的發布。通過與 Vifor 的合作夥伴關係，我的意思是這將是我們從該組織中獲得的令人難以置信的影響力。是的，發射需要投資。但在這種情況下，它不是 - 這是對人員的非常小的投資，也許是幾個營銷人員。

But -- and we dusted off a launch plan that we had a year ago, and I think it would be -- obviously would be a phenomenal outcome for us. But again, as Dave said, I mean, we've built our budget without, right? We want the company to have the discipline of we want to drive to positive cash with Auryxia alone and a disciplined approach to the spending. And that the team has done a phenomenal job of delivering on that. And we expect to continue to deliver towards that in '23.

但是——我們重新制定了一年前的啟動計劃，我認為這對我們來說顯然是一個非凡的結果。但是，正如戴夫所說，我的意思是，我們已經建立了預算，對吧？我們希望公司有紀律，我們希望僅靠 Auryxia 就能獲得正現金，並有紀律地對待支出。而且團隊在實現這一目標方面做得非常出色。我們希望在 23 年繼續實現這一目標。

And our next question coming from the line of Ed Arce with H.C. Wainwright.

我們的下一個問題來自 Ed Arce 和 H.C.溫賴特。

Congrats on all the operational progress in 2022, including the strong growth of Auryxia. First question for me. I noticed you mentioned you have signed a European license agreement with Averoa for Auryxia in Europe. I'm wondering if you could just discuss what you expect there. What kind of communications we can expect going forward with that? And what's your expectations for the end of exclusivity in those markets?

祝賀 2022 年的所有運營進展，包括 Auryxia 的強勁增長。我的第一個問題。我注意到你提到你已經與 Averoa 在歐洲簽署了 Auryxia 的歐洲許可協議。我想知道你是否可以在那裡討論你的期望。我們可以期待什麼樣的溝通？您對這些市場的排他性結束有何期望？

Thanks for the question. So Averoa is a small European company. And again, with Auryxia, we've only had the product available in the U.S. And the idea of bringing this to European patients where we think there can be a benefit has always been attractive for us. We -- but we knew this is something we weren't going to execute on our own.

謝謝你的問題。所以 Averoa 是一家小型歐洲公司。再一次，對於 Auryxia，我們只在美國有這種產品。將這種產品帶給我們認為可能有益的歐洲患者的想法一直對我們很有吸引力。我們 - 但我們知道這是我們不會自己執行的事情。

So bringing in a partner to look at this and look at it a little bit differently. They've got to look at the market just a little bit differently, and they're working on that now and they're consulting with regulatory authorities, and we tried to put a contract in place here that created upside for us if they're successful with very, very little -- I won't say downside risk, but distraction for the organization.

因此，請一位合作夥伴來看待這個問題，並以不同的方式看待它。他們必須以稍微不同的方式看待市場，他們現在正在努力，他們正在與監管機構協商，我們試圖在這裡制定一份合同，如果他們“用非常非常少的東西獲得成功——我不會說下行風險，而是對組織的干擾。

And that was quite important. So again, we're living our purpose of bringing the products to patients where there is a need but doing it in a way that really just creates potential upside for us. Remember, in Europe, you have data exclusivity time frame, blanking on the amount of time it is. But that's what they'll be relying on rather than patent protection per se in the market. So there's an opportunity there.

這非常重要。因此，我們再次實現了將產品帶給有需要的患者的目標，但這樣做的方式確實為我們創造了潛在的好處。請記住，在歐洲，您有數據獨占時間框架，並在時間長度上消隱。但這就是他們將依賴的東西，而不是市場上的專利保護本身。所以那裡有機會。

This is a deal that -- obviously, a royalty-based deal for us, they're taking some risk, and we're taking very little, but the upside is if they're successful in the way they approach the EMA with this. So we'll see. I wouldn't say this is something that we put a significant amount of focus on as we think about building the company, but we're happy with Averoa as a partner and look forward to supporting them as necessary.

這是一筆交易 - 顯然，對我們來說，這是一筆基於版稅的交易，他們承擔了一些風險，而我們承擔的風險很小，但好處是如果他們以這種方式接近 EMA 的方式取得成功.所以我們拭目以待。我不會說這是我們在考慮建立公司時非常關注的事情，但我們很高興與 Averoa 成為合作夥伴，並期待在必要時支持他們。

Okay. And then you also mentioned in the release that you're working on certain initiatives to extend the revenues of Auryxia beyond March 2025. I wondered if you would care to expand upon that in any way and perhaps related -- I think I heard brief mention on your -- in your prepared remarks of TDAPA. I'm wondering if there is any opportunity for you to leverage that come 2025.

好的。然後你還在新聞稿中提到，你正在開展某些計劃，以將 Auryxia 的收入延長到 2025 年 3 月以後。我想知道你是否願意以任何方式和可能相關的方式擴展它——我想我聽到了簡短的提及在您準備好的 TDAPA 評論中。我想知道您是否有機會在 2025 年利用它。

Thanks, Ed. Yes, that's very much, I think, what -- where Dave really was focused in that comment. I mean there's 2 pieces. I mean, one, first and foremost, there is -- we have this ANDA settlements of March of '25. And -- but we do know that if you look at the analog of Sevelamer, given the volume of drug that has to be manufactured per patient, it took quite some time before there was significant generic entry into the market.

謝謝，埃德。是的，我想這就是 Dave 真正關注的地方。我的意思是有 2 件。我的意思是，首先，我們有 25 年 3 月的 ANDA 協議。而且 - 但我們確實知道，如果你看一下 Sevelamer 的類似物，考慮到每個患者必須生產的藥物量，在大量仿製藥進入市場之前需要相當長的時間。

And it wasn't a patent cliff. It was a patent slope. Ultimately, they did come in, but Sanofi at that time who's selling the drug had significant profitability from that. And so there's some opportunity that -- and here we have a product that's much smaller revenue product. That was $1 billion product, Sevelamer, at that time. So is it financially attractive for a number of generic manufacturers to bring the product in, that's an assessment they have to make.

這不是專利懸崖。這是一個專利斜坡。最終，他們確實進來了，但當時銷售這種藥物的賽諾菲從中獲得了可觀的利潤。因此，有一些機會——在這裡，我們的產品收入要小得多。那是當時價值 10 億美元的產品司維拉姆。因此，對於許多仿製藥製造商來說，引入該產品在經濟上是否具有吸引力，這是他們必須做出的評估。

But what's unique to the situation we're in today is, as you said, the TDAPA process that -- CMS has said that the phosphate binders will go into the bundle as of January 25, which has been the expectation. But in the last final rule, they made that clear -- and they made it clear that they were going to have a 2-year TDAPA process. I think a 3-year TDAPA process, which they did for cinacalcet would be more appropriate, we are talking to them about that.

但正如您所說，我們今天所處情況的獨特之處在於 TDAPA 流程—— CMS 表示磷酸鹽結合劑將於 1 月 25 日進入捆綁，這一直是預期的。但在最後一條最終規則中，他們明確表示他們將進行為期 2 年的 TDAPA 流程。我認為他們為西那卡塞所做的為期 3 年的 TDAPA 過程會更合適，我們正在與他們討論這個問題。

But with a 2-year TDAPA process, it means they're collecting data for those 2 years to see how the dialysis providers utilize phosphate binders, so they can make a decision about what to -- what dollar amount to add to the bundled payment come January of '27. So if you think about this from a dialysis provider standpoint, there's a lot of motivation to use. Obviously, they treat patients appropriately, but to use products like branded products so that they're not going to end up with a bundled payment that doesn't cover their costs ultimately.

但是有了 2 年的 TDAPA 流程，這意味著他們正在收集這 2 年的數據，以了解透析提供者如何利用磷酸鹽結合劑，這樣他們就可以決定要做什麼——在捆綁支付中增加多少美元27 年 1 月到來。因此，如果您從透析提供者的角度考慮這一點，就會有很大的使用動機。顯然，他們會適當地對待患者，但會使用品牌產品之類的產品，這樣他們就不會以最終無法支付費用的捆綁付款告終。

So there is clearly an opportunity for us with Auryxia over the course of '25 and '26 to work with them on utilizing the drug appropriately for patients, of course, but increasing -- continuing to increase the utilization and then helping with that switch over to generics beyond 2026. So there's some really, I think, some meaningful revenue opportunities there, and we're just now working with dialysis providers to see how that will be rolled out.

因此，在 25 年和 26 年的過程中，我們顯然有機會與 Auryxia 合作，為患者適當地使用這種藥物，當然，但增加 - 繼續增加利用率，然後幫助轉換到 2026 年以後彷製藥。所以我認為，那裡確實有一些有意義的收入機會，我們現在正在與透析供應商合作，看看將如何推出。

Okay. Great. And then one last question. I joined a bit late, so maybe you discussed this already, but I just wanted to clarify for vadadustat in the U.S. If that process were to ultimately result in an approval, commercially, what is your plan right now?

好的。偉大的。然後是最後一個問題。我加入有點晚，所以也許你已經討論過了，但我只是想為美國的 vadadustat 澄清一下。如果這個過程最終導致商業上的批准，你現在的計劃是什麼？

So the focus of the FDRR now is for patients -- it's for dialysis patients only. So that would be the expectation of what an approval would yield. And the commercial organization that we've put in place now -- the reorganization we did late last year, we think from a field perspective, we probably have to add a couple of marketing people. But from a field perspective, we have what we need for that launch because of the Vifor relationship, right? We have -- the Vifor relationship that we have, where they have, we'll sell directly to Fresenius and the other small and medium providers who have contracts. They have contracts that really allows us to have a much more efficient commercial focus and delivers a tremendous amount of leverage for us on our P&L if we're successful with that.

因此，FDRR 現在的重點是患者——它只針對透析患者。因此，這就是對批准結果的預期。我們現在已經建立的商業組織——我們去年年底進行的重組，我們認為從現場的角度來看，我們可能需要增加幾個營銷人員。但從現場的角度來看，由於與 Vifor 的關係，我們擁有了發布所需的東西，對嗎？我們有——我們擁有的 Vifor 關係，在他們擁有的地方，我們將直接出售給費森尤斯和其他有合同的中小型供應商。他們的合同確實使我們能夠更加有效地關注商業重點，並在我們成功實現這一目標的情況下為我們的損益提供巨大的影響力。

Our next question coming from the line Robert Hazlett with BTIG.

我們的下一個問題來自 BTIG 的 Robert Hazlett。

Congrats on the progress. Looking forward to more. Just a quick question on margins for this quarter. I think you mentioned it in the call -- in the release. But COGS had a benefit this quarter. I think there was some mention about contract termination fees. Could you go into a little bit more detail about how we should be thinking about the cost of goods and gross margin?

祝賀進步。期待更多。只是一個關於本季度利潤率的快速問題。我想你在電話中提到過——在發布中。但 COGS 在本季度有收益。我認為有人提到了合同終止費。您能否更詳細地說明我們應該如何考慮商品成本和毛利率？

Again, I know you're not commenting on expense guidance, but just in general, thinking about the operations of Auryxia and costs and gross margins and things in general.

同樣，我知道你不是在評論費用指導，而是在一般情況下，考慮 Auryxia 的運營、成本、毛利率和一般情況。

Yes. Thanks for the question, Bert. So as folks are aware, back in December, we [acted] a release on the termination of a supply contract that we had a multiyear supply contract between the different supply agreements that we had back then. We had in each quarter been providing updates on something that we call an excess purchase commitment. With the restructuring of the supply chain, we expect that those charges are going away, and we have reversed those charges in the fourth quarter.

是的。謝謝你的問題，伯特。因此，正如人們所知，早在 12 月，我們就終止供應合同發布了一份聲明，我們當時在不同的供應協議之間簽訂了多年供應合同。我們在每個季度都提供了我們稱之為超額購買承諾的更新。隨著供應鏈的重組，我們預計這些費用將會消失，我們已經在第四季度取消了這些費用。

So what you'll see going forward within that COGS line, you'll still see the amortization of intangible that is clearly in there and called out as a noncash expense. But what you'll see now is you'll see a much more normal cost of goods line, which would be just our cost to produce and sell Auryxia.

因此，您將在該 COGS 線中看到未來的發展，您仍然會看到無形資產的攤銷，這些攤銷顯然在那裡，並被稱為非現金支出。但你現在會看到的是，你會看到一條更正常的商品成本線，這只是我們生產和銷售 Auryxia 的成本。

And that will be -- again, we're not providing the specific numbers, but you can go back historically and look at what we've disclosed, whether it's excess purchase or inventory write-offs, take those to the side, and it will just be a much more normal rate.

那將是——同樣，我們沒有提供具體數字，但你可以回顧歷史，看看我們披露的內容，無論是超額採購還是庫存註銷，把它們放在一邊，然後它將只是一個更正常的速度。

And we're really, really happy about those contract terminations and reworks because it does save us a real significant amount on the cash flow. And again, a big, big contributor to us having this cash runway that we're talking about now has been changing of those contracts. It was in excess of $70 million that we reversed for those excess purchase commitments.

我們對那些合同終止和返工真的非常高興，因為它確實為我們節省了大量的現金流。再一次，我們現在談論的這條現金跑道的一個很大的貢獻者一直在改變這些合同。我們因這些超額購買承諾而撤銷的金額超過 7000 萬美元。

Terrific. Looking forward to cleaner numbers moving forward. That's great. A couple on -- I bet -- a couple of questions on vadadustat and in the U.S. is Dr. Stein seeking additional data from Akebia at all? Are you interacting with him directly in any way, shape or form?

了不起。期待更清潔的數字向前發展。那太棒了。關於——我敢打賭——關於 vadadustat 和美國的幾個問題，Stein 博士是否正在尋求 Akebia 的更多數據？您是否以任何方式、形式或形式直接與他互動？

So the focus of the letter is the internal discussions that he's having. If he requests anything from us, obviously, we'll be responsive to that. Part of the FDRR is that you can't actually give new data into the review, so we couldn't proactively give him anything new to look at. It's got to be all things that are included in the NDA. That's part of the rules of the FDRR. So I mean, I think his initial focus is certainly -- I don't want to speak for him, but coming up to speed, clearly from his letter, he's come up to speed a long way.

所以這封信的重點是他正在進行的內部討論。如果他向我們提出任何要求，顯然，我們會予以回應。 FDRR 的一部分是您實際上不能在審查中提供新數據，因此我們無法主動給他任何新數據以供查看。它必須是 NDA 中包含的所有內容。這是 FDRR 規則的一部分。所以我的意思是，我認為他最初的重點當然是——我不想代表他說話，但從他的信中可以清楚地看出，他已經加快了很長的路要走。

I mean he really was quite [adverse] in the issues at hand but wants to seek that internal guidance. So I think it's more about that. We are -- we will do everything we can to support him in that process and support a positive outcome. So having a direct communication with him on these issues is something we would be clearly welcome.

我的意思是他在手頭的問題上確實非常[不利]，但想尋求內部指導。所以我認為更重要的是。我們是——我們將竭盡所能在該過程中支持他並支持取得積極成果。因此，我們顯然歡迎就這些問題與他直接溝通。

Okay. Terrific. And then just thinking about -- again, there's a little bit of additional data coming up the focus study, the 3x weekly data. What does this give you? What should we expect in terms of data release for that study?

好的。了不起。然後再想想——再一次，重點研究中還有一些額外的數據，每週 3 倍的數據。這給你什麼？就該研究的數據發布而言，我們應該期待什麼？

Yes. So I mean we do expect that we'll be presenting that data at a scientific session or in a publication to be determined. It's an important study. It is the study that we feel will be the basis for having a 3 times weekly dose for vadadustat in our label. And obviously, with the -- in dialysis patients, right?

是的。所以我的意思是我們確實希望我們將在科學會議或出版物中展示這些數據。這是一項重要的研究。我們認為這項研究將成為我們標籤中每週 3 次 vadadustat 劑量的基礎。顯然，對於透析患者，對嗎？

So even with a negative outcome in the U.S., we have a positive outcome in Europe and having that ability for dialysis providers to deliver the drug when the patients on dialysis is just another option for them that can be very helpful and ensure compliance for their patients. And so it's important -- and I think it's important for patients, and it's important commercially too. It's giving physicians more of an option. So that study is completing, and we do expect that, that data will be presented this year.

因此，即使在美國出現負面結果，我們在歐洲也取得了積極的結果，並且透析提供者能夠在透析患者提供藥物時提供藥物，這對他們來說只是另一種選擇，這對他們非常有幫助並確保患者的依從性.所以這很重要——我認為這對患者很重要，在商業上也很重要。它為醫生提供了更多選擇。因此，該研究即將完成，我們確實預計，該數據將在今年公佈。

Okay, terrific. And just one more. I think you talked about this to some degree, but -- sorry to kind of come back to it. But I just -- maybe a little bit more formally. What would a label look like in the eve for vadadustat as Vafseo as we're moving forward. Just any kind of broad characterization you can do -- you can provide for the potential authorization may would be helpful.

好的，太棒了。還有一個。我認為你在某種程度上談到了這一點，但是 - 很抱歉回到它。但我只是——也許更正式一點。在我們前進的過程中，vadadustat 前夕的標籤會像 Vafseo 一樣。您可以做的任何一種廣泛的描述——您可以提供潛在的授權可能會有所幫助。

So obviously, until we have that marketing authorization, we don't want to kind of get ahead of that. But you obviously are talking about a label as you go through the CHMP. And we're very pleased from kind of -- at least I'm looking at it with a commercial eye. And I think it's a label that we absolutely can work with. There's nothing that's outside of what I would expect in there. And I mean, obviously, focused on dialysis patients alone. But when I look at the concerns expressed by the FDA, those are either -- those are all handled in a very appropriate way in the SmPC. So the anticipated SmPC. So we'll see the final when we have it. But I have no concerns from a commercial perspective based on what I've seen so far.

所以很明顯，在我們獲得營銷授權之前，我們不想領先於此。但是當您通過 CHMP 時，您顯然是在談論標籤。我們從某種程度上感到非常高興——至少我是用商業眼光來看待它的。我認為這是一個我們絕對可以合作的標籤。沒有什麼超出我的預期。我的意思是，很明顯，只關注透析患者。但是，當我查看 FDA 表達的擔憂時，這些擔憂都是——這些都在 SmPC 中以非常適當的方式處理。因此，預期的 SmPC。所以當我們有它時，我們會看到決賽。但根據我目前所見，從商業角度來看，我並不擔心。

Terrific. And just one more along those lines, how would you characterize the status of interactions for folks with additional commercial parties in the EU. You said pretty clearly that obviously nothing is going to happen until formal authorization. But I just love to get a sense of the temperament out there.

了不起。再說一個，你如何描述人們與歐盟其他商業團體的互動狀態。你說得很清楚，在正式授權之前顯然什麼都不會發生。但我只是喜歡感受那裡的氣質。

Yes. No, it's a very active process. It's getting clarity that it's dialysis versus dialysis and non-dialysis, obviously, it was important to the process. Having the CHMP positive opinion is very value-creating for us and having an authorization creates more value for us, ultimately, as you get to a deal. And creating -- we have an active process with multiple parties who are interested. And seeing that process through and maintaining multiple parties usually yields the best outcome for us and for the product. And if that takes a little bit more time, that's time that's usually very, very well spent. So we're very pleased with how this process is moving forward.

是的。不，這是一個非常活躍的過程。它越來越清楚，它是透析與透析和非透析，顯然，這對這個過程很重要。獲得 CHMP 的積極意見對我們來說非常創造價值，而獲得授權會為我們創造更多價值，最終，當您達成交易時。並創建 - 我們有一個與感興趣的多方的積極流程。並且通過多方維護該過程通常會為我們和產品產生最佳結果。如果這需要多一點時間，那通常是非常非常值得花的時間。所以我們對這個過程的進展感到非常高興。

Congrats on the progress. Looking forward to more.

祝賀進步。期待更多。

I'm showing no further questions at this time. I will now turn the call back over to Mr. John Butler for any closing remarks.

我現在沒有進一步的問題。我現在將把電話轉回給約翰·巴特勒先生，聽取任何結束語。

Thanks, operator, and thank you all for your attendance this morning. While we celebrate World Kidney Day today, our commitment to patients drives us forward every day. And I hope you got a sense of our excitement from this call. I just want to really summarize very quickly a few of the exciting developments we're expecting in 2023. We're going to continue to drive revenue growth for Auryxia and expect to deliver net product revenue of $175 million to $180 million.

謝謝接線員，感謝大家今天早上的出席。在我們今天慶祝世界腎臟日的同時，我們對患者的承諾每天都在推動我們前進。我希望您能從這次電話會議中感受到我們的興奮。我只想快速總結一下我們在 2023 年期待的一些令人興奮的發展。我們將繼續推動 Auryxia 的收入增長，並預計實現 1.75 億美元至 1.8 億美元的產品淨收入。

We received a positive opinion from the CHMP for vadadustat and anticipate marketing authorization in a couple of months. We expect a regulatory decision for the ACCESS Consortium countries. We anticipate engaging a partner to commercialize vadadustat in Europe. We expect a decision on the FDRR process with the FDA. We anticipate that UT Health will initiate an ARDS study with vadadustat in a broader patient population.

我們收到了 CHMP 對 vadadustat 的積極意見，並預計將在幾個月內獲得上市許可。我們期待對 ACCESS 聯盟國家做出監管決定。我們預計會聘請合作夥伴在歐洲將 vadadustat 商業化。我們期待與 FDA 就 FDRR 流程做出決定。我們預計 UT Health 將在更廣泛的患者群體中使用 vadadustat 啟動 ARDS 研究。

And we look forward to talking much more about our pipeline development for vadadustat and other novel HIF-PHI compounds as the year progresses. So it will be a very, very busy year for us, I think, an exciting year for Akebia, and we look forward to updating you further on it. Thanks again for joining us. Have a great day.

隨著時間的推移，我們期待著更多地討論我們對 vadadustat 和其他新型 HIF-PHI 化合物的管道開發。因此，我認為，對我們來說，這將是非常非常忙碌的一年，對 Akebia 來說，這是令人興奮的一年，我們期待為您提供進一步的更新。再次感謝您加入我們。祝你有美好的一天。

Ladies and gentlemen, that does conclude the conference for today. Thank you for your participation. You may now disconnect.

女士們，先生們，今天的會議到此結束。感謝您的參與。您現在可以斷開連接。