Ardelyx Inc (ARDX) 2023 Q3 法說會逐字稿

Good day, and welcome to the Ardelyx Third Quarter 2023 Earnings Conference Call. (Operator Instructions) After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note, this event is being recorded.

美好的一天，歡迎參加 Ardelyx 2023 年第三季財報電話會議。 （操作員說明）今天的演示結束後，將有機會提問。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations at Ardelyx. Please go ahead.

我現在想將會議交給 Ardelyx 企業傳播和投資者關係副總裁 Caitlin Lowie。請繼續。

Thank you. Good morning, and welcome to our third quarter financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investors section of the company's website at ardelyx.com.

謝謝。早上好，歡迎參加我們的第三季財務業績電話會議。在本次電話會議中，我們將參考今天稍早發布的新聞稿，該新聞稿可在公司網站 ardelyx.com 的投資者部分取得。

During this call, we'll be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q that was filed today and can be found on our website at ardelyx.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change.

在本次電話會議中，我們將做出前瞻性陳述，這些陳述存在風險和不確定性。我們的實際結果可能與描述的結果有重大差異。我們鼓勵您查看我們今天提交的最新季度報告 10-Q 表格中的風險因素，該報告可以在我們的網站 ardelyx.com 上找到。雖然我們可能選擇在未來更新這些前瞻性陳述，但我們特別聲明不承擔任何這樣做的義務，即使我們的觀點改變。

Our President and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's progress during the third quarter of 2023.

我們的總裁兼執行長 Mike Raab 將在今天的電話會議中致開幕詞並概述公司在 2023 年第三季的進展。

Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the performance of IBSRELA and the launch of XPHOZAH following its approval earlier this month.

接下來，商務長 Susan Rodriguez 將提供有關 IBSRELA 業績的最新資訊以及本月稍早獲得批准後 XPHOZAH 的推出情況。

Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the quarter ended September 30, 2023, before we open the call to questions.

在我們開始提問之前，財務和營運長賈斯汀·倫茨 (Justin Renz) 將回顧公司截至 2023 年 9 月 30 日的季度的財務業績，以總結今天準備好的發言。

With that, let me pass the call over to Mike.

接下來，讓我把電話轉給麥克。

Good morning, everyone, and thank you for joining us on the call. I'm very pleased to be here once again, just a short few weeks after we celebrated the approval of XPHOZAH. With this approval, we now have delivered on our mission to provide patients with medicines that matter for the second time. It is something I am immensely proud of.

大家早安，感謝您加入我們的電話會議。我很高興再次來到這裡，就在我們慶祝 XPHOZAH 獲得批准短短幾週後。憑藉這項批准，我們現在已經履行了我們的使命，第二次為患者提供重要的藥物。這是我感到非常自豪的事。

Today, Susan, Justin and I will share details on the performance from the third quarter, as well as important updates from the first couple of weeks following -- in the fourth quarter following the announcement of XPHOZAH's approval.

今天，蘇珊、賈斯汀和我將分享第三季度業績的詳細信息，以及在宣布 XPHOZAH 獲得批准後的第四季度的前幾週的重要更新。

Before I hand it over to them, let me share a few of my thoughts on the third quarter and what we expect in the near future for Ardelyx. First, IBSRELA momentum continues. Our quarter-over-quarter growth in Q3 was driven by a clear need patients have for new medicine to address the challenging and sometimes intractable symptoms experienced by patients with IBS-C.

在我將其交給他們之前，讓我分享一下我對第三季的一些想法以及我們對 Ardelyx 不久的將來的期望。首先，IBSRELA 勢頭仍在繼續。我們第三季的環比成長是由患者對新藥的明確需求推動的，以解決 IBS-C 患者所經歷的具有挑戰性的、有時是棘手的症狀。

IBSRELA is establishing a unique role in what has traditionally been thought to be a challenging market to penetrate. We are demonstrating that when you have a novel mechanism product, with a strong safety and efficacy profile that is benefiting patients and when you're thinking differently about marketing innovative products that you can disrupt markets.

IBSRELA 正在傳統上被認為是一個難以滲透的市場中發揮獨特的作用。我們正在證明，當您擁有一種新穎的機制產品，具有強大的安全性和有效性，可以使患者受益，並且當您以不同的方式行銷創新產品時，您就可以擾亂市場。

Second, XPHOZAH is ready for success. As Susan discussed on our approval call, awareness, interest and intent to adopt XPHOZAH are high among the nephrology community. The response to our approval has been nothing short of amazing. It is also humbling as we now have the responsibility to deliver for patients.

其次，XPHOZAH 已為成功做好了準備。正如 Susan 在我們的批准呼籲中所討論的那樣，腎臟病學界對採用 XPHOZAH 的認識、興趣和意願都很高。我們的批准得到的反應非常驚人。這也令人感到謙卑，因為我們現在有責任為病人提供服務。

We've received words of congratulations from across the kidney community with nephrologists expressing their excitement about having this novel therapy available to prescribe for their patients.

我們收到了來自整個腎臟界的祝賀，腎臟病專家表達了他們對能夠為患者開出這種新療法的興奮之情。

As we've shared, there is significant pent-up demand, and we expect strong uptake at launch. Our sales team is already in the field, and we expect to have XPHOZAH at our distributors shortly after the conclusion of ASN's Kidney Week. The new era for managing hyperphosphatemia among kidney patients is here.

正如我們所分享的，存在著大量被壓抑的需求，我們預計發佈時會有強勁的需求。我們的銷售團隊已經在現場，我們預計 ASN 腎臟週結束後不久就會在我們的經銷商處銷售 XPHOZAH。治療腎臟病患者高磷血症的新時代已經來臨。

Finally, we are well resourced for the foreseeable future. We carefully and thoughtfully financed the company and have a strong cash position as a result, sufficient to fund the commercialization of XPHOZAH and support the critical ongoing investment in IBSRELA. We will also begin investments in R&D in the coming quarters as we work towards the next phase of Ardelyx.

最後，我們在可預見的未來擁有充足的資源。我們精心、周到地為該公司提供資金，因此擁有強大的現金狀況，足以為 XPHOZAH 的商業化提供資金並支持對 IBSRELA 的關鍵持續投資。我們也將在未來幾季開始投資研發，努力邁向 Ardelyx 的下一階段。

I will now hand it to Susan, who will share more on IBSRELA's performance and additional details on the launch activities for XPHOZAH. Susan?

現在我將把它交給 Susan，她將分享更多有關 IBSRELA 的表現以及 XPHOZAH 啟動活動的更多細節。蘇珊？

Thank you, Mike. It is great to be back today, speaking about IBSRELA and now XPHOZAH. We continue to disrupt the established IBS-C market, with Q3 revenue for IBSRELA at $22.3 million, reflecting a 22% increase versus Q2. This first-in-class drug can offer meaningful benefit to patients who have been in need of a novel approach.

謝謝你，麥克。很高興今天回來談論 IBSRELA 和 XPHOZAH。我們繼續顛覆現有的 IBS-C 市場，IBSRELA 第三季營收為 2,230 萬美元，比第二季成長 22%。這種一流的藥物可以為需要新方法的患者帶來有意義的益處。

As I've noted on previous earnings calls, our growth is consistent and persistent. New prescriptions are growing, retail prescriptions are growing. We continue to grow new writers and existing writers are expanding their use. These results reflect the extent to which physicians continue to identify more and more of their patients as candidates for IBSRELA, that patients are getting access to IBSRELA, and that their treatment experience is favorable.

正如我在之前的財報電話會議上指出的那樣，我們的成長是一致且持久的。新處方不斷增長，零售處方不斷增長。我們不斷增加新的寫入器，現有寫入器正在擴大其使用範圍。這些結果反映了醫生繼續將越來越多的患者識別為 IBSRELA 候選人、患者正在接受 IBSRELA 以及他們的治療體驗良好的程度。

Our team's efforts are supported by the strong clinical data package for IBSRELA, which we continue to expand. Just recently, at the American College of Gastroenterology Meeting in Vancouver, we had a significant commercial and medical presence, which included a well-attended product theater, as well as 2 posters and an oral presentation on data analysis about symptom response during treatment with IBSRELA.

我們團隊的努力得到了 IBSRELA 強大的臨床資料包的支持，我們也持續擴展這些資料包。就在最近，在溫哥華舉行的美國胃腸病學會會議上，我們進行了重要的商業和醫療展示，其中包括一個出席人數眾多的產品劇院，以及2 張海報和關於IBSRELA 治療期間症狀反應數據分析的口頭示範。

Our research was incredibly well received. Our poster titled, Tenapanor Can Improve Abdominal Symptoms Independent of Changes in Bowel Movement Frequency in Adult Patients with IBS-C, authored by notable opinion leaders, Dr. Darren Brenner and Dr. Tony Lembo as well as Ardelyx scientists, was recognized with the Presidential Poster Award by the ACG Abstract Selection Committee. Awarded to less than 5% of all posters, this distinction recognizes high-quality, unique research.

我們的研究非常受歡迎。我們的海報題為《Tenapanor 可以改善 IBS-C 成人患者的腹部症狀，不受腸蠕動頻率變化的影響》，由著名意見領袖 Darren Brenner 博士和 Tony Lembo 博士以及 Ardelyx 科學家撰寫，獲得了總統府的認可ACG摘要評選委員會海報獎。該獎項僅頒發給不到 5% 的發文者，旨在表彰高品質、獨特的研究。

Our dedicated team is fully engaged with the physician community and carving out a meaningful role for IBSRELA among the IBS-C patient population. Based on the uptake we are seeing, it is clear that the potential for IBSRELA is high among this target group of patients who are in need of a novel option, and that IBSRELA is on pace to achieve a high single-digit market share position across this 5 million script market over time.

我們的專業團隊與醫生界充分互動，並為 IBSRELA 在 IBS-C 患者群體中發揮有意義的作用。根據我們所看到的應用情況，很明顯，IBSRELA 在需要新選擇的目標患者群體中具有很高的潛力，並且 IBSRELA 正在努力實現高個位數的市場份額地位隨著時間的推移，這個500 萬個腳本市場。

With the price point we established within this market, enabled by the value of its innovation and the favorable uptake dynamics driven by the patient need, we are well positioned for success with IBSRELA.

憑藉我們在這個市場中確立的價格點，以及其創新價值和患者需求驅動的有利吸收動力，我們已經做好了 IBSRELA 成功的準備。

Turning to XPHOZAH. During our call a few weeks ago, I characterized in detail the dynamics and our commercial approach. I will summarize those briefly before discussing our pricing and access strategy in more detail.

轉向 XPHOZAH。在幾週前的電話會議中，我詳細描述了動態和我們的商業方法。在更詳細地討論我們的定價和存取策略之前，我將簡要總結這些內容。

The market dynamics for XPHOZAH are favorable. Hyperphosphatemia is a well-established therapeutic area with treatment goal centered on globally recognized treatment guidelines. 80% of the estimated 550,000 patients with CKD on dialysis in the U.S. are treated with a prescription therapy in an effort to control their elevated levels of serum phosphorus. Of those being treated, it has been shown that 77% are unable to consistently maintain target levels of serum phosphorus over a 6-month period.

XPHOZAH 的市場動態是有利的。高磷血症是一個成熟的治療領域，其治療目標以全球公認的治療指南為中心。在美國，估計有 55 萬名接受透析的 CKD 患者，其中 80% 接受處方療法治療，以控制血清磷水平升高。研究表明，在接受治療的患者中，77% 的患者無法在 6 個月內持續維持血清磷的目標水準。

The market is primed and ready for XPHOZAH. Nearly 70% of surveyed nephrologists report a high or very high need for a new treatment option, and among nephrologists aware of new treatments for hyperphosphatemia, 3 quarters mentioned tenapanor by name.

市場已為 XPHOZAH 做好準備。近 70% 的受訪的腎臟科醫生表示非常需要新的治療方案，並且在了解高磷血症新療法的腎臟科醫生中，四分之三的人提到了特納帕諾的名字。

Surveyed nephrologists rate the novel mechanism, efficacy, tolerability and dosing attributes favorably, and 59% reported that they intend to adopt XPHOZAH within the first 6 months of product availability.

受訪的腎臟病專家對新機制、功效、耐受性和劑量屬性給予好評，59% 的人表示他們打算在產品上市的前 6 個月內採用 XPHOZAH。

Ardelyx is well positioned to capitalize on this opportunity. Positioning for XPHOZAH will center on integrating a novel blocking mechanism therapy for their binder treated patients who have an inadequate response or are intolerant to any dose of binder therapy. WAC pricing for XPHOZAH will be set at $2,960 per month of therapy, reflecting the value XPHOZAH brings to patients, in the context of the CKD market pricing landscape.

Ardelyx 已做好充分利用此機會的準備。 XPHOZAH 的定位將集中在為黏合劑治療反應不足或對任何劑量的黏合劑治療不耐受的患者整合一種新型阻斷機制療法。 XPHOZAH 的 WAC 定價將定為每月 2,960 美元，反映了 XPHOZAH 在 CKD 市場定價格局的背景下為患者帶來的價值。

We have built a dedicated nephrology sales force of 60 reps that cover the approximately 8,000 nephrology health care providers who write the majority of the hyperphosphatemia prescription. Our distribution network is also in place and will provide full coverage across the U.S. aligned optimally to our access strategy.

我們建立了一支由 60 名代表組成的專門腎臟病銷售隊伍，涵蓋約 8,000 名腎臟病醫療保健提供者，他們開出了大部分高磷血症處方。我們的分銷網絡也已就位，並將全面覆蓋美國各地，並與我們的准入策略保持最佳一致。

Our comprehensive patient services program, ArdelyxAssist, has gone live for XPHOZAH and is receiving calls. Product is on track to be in the channel following ASN's Kidney Week in early November.

我們的綜合患者服務計劃 ArdelyxAssist 已在 XPHOZAH 上線並正在接聽電話。該產品預計將在 11 月初的 ASN 腎臟週之後進入渠道。

As I outlined in our approval call, there are 3 foundational components to our go-to-market approach, centered on enabling nephrologists to integrate first-in-class phosphate absorption inhibitor XPHOZAH into the treatment regimen of their binder treated patients who have had an inadequate response or cannot tolerate any dose of binder therapy.

正如我在批准呼籲中概述的那樣，我們的上市方法有3 個基本組成部分，重點是使腎臟科醫生能夠將一流的磷酸鹽吸收抑製劑XPHOZAH 納入其接受粘合劑治療的患者的治療方案中。反應不足或不能耐受任何劑量的黏合劑治療。

First, XPHOZAH is novel. It is a first-in-class phosphate absorption inhibitor. It is not a binder. This is a significant innovation for patients who up until now have only had 1 treatment option for managing hyperphosphatemia.

首先，XPHOZAH 很新穎。它是一流的磷酸鹽吸收抑制劑。它不是黏合劑。對於迄今為止只有一種治療方案來控制高血磷症的患者來說，這是一項重大創新。

Second, patients are in need of innovation, the vast majority of the 550,000 CKD patients on dialysis who are treated with a phosphate binder to lower their phosphorus levels are unable to consistently achieve or maintain target levels.

其次，患者需要創新，在 55 萬名接受透析的 CKD 患者中，絕大多數接受磷酸鹽結合劑治療以降低磷水平，但無法持續達到或維持目標水平。

And third, Ardelyx's commitment to patient access and affordability. Patients prescribed XPHOZAH will have access to comprehensive prior authorization support and affordability program. ArdelyxAssist connects providers, payers and specialty services to help facilitate prior authorization and other administrative processes. For commercial patients, their co-pays will be covered at the level of 100%. Patients unable to afford XPHOZAH can apply for our patient assistance program that provides drug at no cost to patients who need the program's broad eligibility criteria.

第三，Ardelyx 對病人獲取和負擔能力的承諾。服用 XPHOZAH 的患者將可以獲得全面的事先授權支援和負擔能力計劃。 ArdelyxAssist 連結提供者、付款人和專業服務，以協助促進事先授權和其他管理流程。對於商業患者，他們的自付費用將達到 100%。無法負擔 XPHOZAH 的患者可以申請我們的患者援助計劃，該計劃為需要該計劃廣泛資格標準的患者免費提供藥物。

I'd like to further characterize the access landscape and our access strategy, as we received a number of questions following our approval call 2 weeks ago. XPHOZAH, like IBSRELA, will be available to patients through a prior authorization process. We have been engaged with payers for several months to educate them on XPHOZAH, its novel mechanism of action, clinical data, and now, the approved label.

我想進一步描述訪問環境和我們的訪問策略，因為我們在兩週前的批准電話會議後收到了許多問題。 XPHOZAH 與 IBSRELA 一樣，將透過事先授權流程向患者提供。我們已經與付款人接觸了幾個月，向他們介紹 XPHOZAH、其新穎的作用機制、臨床數據，以及現在批准的標籤。

Over the coming months, payers will issue their coverage policy. We anticipate that the requirement will be that physicians at test that patients have not had an adequate response to their binder treatment or that they are not able to tolerate binder therapy.

在接下來的幾個月裡，付款人將發布他們的核保政策。我們預計，要求醫生在測試中證明患者對其黏合劑治療沒有足夠的反應，或者他們不能耐受黏合劑治療。

While the specifics around the requirements will vary by plan, it is important to note that the majority of patients treated with binders today by nephrologists meet these criteria. What will be most important is that nephrologists prescribe XPHOZAH based on patient need and integrate the prior authorization work stream into their office practice so that patients prescribed XPHOZAH can access XPHOZAH.

雖然具體要求會因計劃而異，但值得注意的是，目前腎臟病專家使用黏合劑治療的大多數患者都符合這些標準。最重要的是，腎臟科醫師根據患者需求開出 XPHOZAH 處方，並將事先授權工作流程整合到他們的辦公室實踐中，以便開出 XPHOZAH 的患者可以使用 XPHOZAH。

Nephrologists are well accustomed to the prior authorization processes as several products commonly used for patients with CKD on dialysis require them. Given the limited agents available today to treat hyperphosphatemia, to recognize unmet patient needs and unopposed position of XPHOZAH as the only non-binder next line option for patients, we anticipate that XPHOZAH will be acceptable via the prior authorization pathway early in the launch.

腎臟科專家非常習慣事先授權流程，因為常用於透析 CKD 患者的幾種產品需要這些流程。鑑於目前可用於治療高磷血症的藥物有限，為了認識到未滿足的患者需求以及XPHOZAH 作為患者唯一的非粘合劑下一線選擇的無可爭議的地位，我們預計XPHOZAH 將在上市初期通過事先授權途徑獲得接受。

We do not intend to contract with payers, and anticipate a steady and persistent uptake of XPHOZAH by HCPs based on addressing the patient's unmet needs and effectively engaging in the prior authorization administrative process.

我們不打算與付款人簽訂合同，並預期 HCP 在解決患者未滿足的需求並有效參與事先授權管理流程的基礎上穩定、持續地採用 XPHOZAH。

The XPHOZAH's sales force has been in the field and will be joining the nephrology community this weekend at the ASN Kidney Week in Philadelphia.

XPHOZAH 的銷售人員一直在現場，並將於本週末在費城舉行的 ASN 腎臟週上加入腎臟病學社區。

In parallel, the IBSRELA sales team maintains their singular focus on disrupting the IBS-C market, also with a first-in-class therapy addressing important unmet patient needs. The Ardelyx commercial team is executing at the highest level with teams of experienced, dedicated and highly capable individuals who are delivering on Ardelyx admissions every day, addressing important unmet treatment needs through innovation.

同時，IBSRELA 銷售團隊繼續專注於擾亂 IBS-C 市場，並透過一流的療法來滿足重要的未滿足的患者需求。 Ardelyx 商業團隊正在以最高水準執行，團隊由經驗豐富、敬業且能力超群的人員組成，他們每天都在為 Ardelyx 入院提供服務，透過創新解決重要的未滿足的治療需求。

With that, I will hand it to Justin.

這樣，我會把它交給賈斯汀。

Thank you, Susan. Ardelyx has delivered on a number of key milestones since August. Continued growth of IBSRELA across all key measures. The approval and the imminent commercial launch of XPHOZAH. The expansion of our commercial organization to support XPHOZAH. The approval of tenapanor for hyperphosphatemia in Japan. The approval of IBSRELA in Hong Kong for IBS-C, which we announced this morning. And an amended loan agreement, which provides additional cash and flexibility to fund our future growth.

謝謝你，蘇珊。自 8 月以來，Ardelyx 已經實現了許多重要的里程碑。 IBSRELA 在所有關鍵指標上均持續成長。 XPHOZAH 的批准和即將商業啟動。擴大我們的商業組織以支持 XPHOZAH。 Tenapanor 在日本核准用於治療高血磷症。我們今天早上宣布了 IBSRELA 在香港批准治療 IBS-C。修訂後的貸款協議為我們未來的成長提供了額外的現金和靈活性。

We find ourselves with a very strong cash position, and we are well resourced to support our ongoing operations including the commercialization of both of our in-market products. With that backdrop, I will discuss the specifics of our financial performance.

我們發現自己擁有非常強大的現金狀況，我們有充足的資源來支持我們的持續運營，包括我們兩種市場產品的商業化。在此背景下，我將討論我們財務表現的具體情況。

In the third quarter of 2023, we had total revenues of $56.4 million, compared to $4.9 million in total revenues during the third quarter of 2022. The increase reflects IBSRELA's net product sales growth, as well as milestone and collaboration payments from our international partners.

2023 年第三季度，我們的總收入為5,640 萬美元，而2022 年第三季的總收入為490 萬美元。這一增長反映了IBSRELA 的淨產品銷售增長，以及我們國際合作夥伴的里程碑付款和合作付款。

Next, let me take you through the relative contributions of our revenue components during the quarter. First, as previously mentioned, we had U.S. net product sales of IBSRELA in the quarter ended September 30, 2023, of $22.3 million, a 22% increase from the $18.3 million we reported in the second quarter. As a reminder, in the third quarter of 2022, we reported IBSRELA net product sales of $4.9 million.

接下來，讓我帶您了解本季我們營收組成部分的相對貢獻。首先，如前所述，截至 2023 年 9 月 30 日的季度，我們的 IBSRELA 產品淨銷售額為 2,230 萬美元，比我們第二季度報告的 1,830 萬美元增長了 22%。提醒一下，我們報告的 2022 年第三季 IBSRELA 產品淨銷售額為 490 萬美元。

Second, we reported other IBSRELA net product supply revenue of $2.1 million related to our international partners. This is compared to 92,000 new product supply revenue in the third quarter of last year.

其次，我們報告了與我們的國際合作夥伴相關的其他 IBSRELA 淨產品供應收入 210 萬美元。相較之下，去年第三季新產品供應收入為 92,000 份。

Third, we recorded $30 million in licensing revenue as a result of milestone and contract amendment payments in Kyowa Kirin, following the approval of tenapanor for hyperphosphatemia in Japan in September.

第三，繼 9 月在日本批准用於治療高磷血症的 Tenapanor 後，由於 Kyowa Kirin 的里程碑付款和合約修訂付款，我們錄得 3000 萬美元的許可收入。

Fourth, we recorded a $2 million milestone payment from Fosun Pharma, following the NDA submission for hyperphosphatemia in China, which we announced back in July.

第四，繼我們於 7 月宣布提交針對中國高磷血症的 NDA 後，我們從復星醫藥中獲得了 200 萬美元的里程碑付款。

And finally, we recorded a small amount of royalty income from Knight Pharmaceuticals as we received a percentage of their IBSRELA net product sales in Canada.

最後，我們記錄了 Knight Pharmaceuticals 的少量特許權使用費收入，因為我們收到了他們在加拿大的 IBSRELA 產品淨銷售額的一定比例。

Overall, our revenues were in line with our expectations regarding U.S. net product sales from IBSRELA, as well as milestone payments related to our international collaboration partners.

總體而言，我們的收入符合我們對 IBSRELA 在美國產品淨銷售額以及與我們的國際合作夥伴相關的里程碑付款的預期。

Looking ahead, we currently expect net drill sales revenue in the U.S. for the full year of 2023 to be between $76 million and $78 million. Please note that this does not include any anticipated sales from XPHOZAH, partner milestone payments or product supply revenues.

展望未來，我們目前預計 2023 年全年美國鑽機淨銷售收入將在 7,600 萬美元至 7,800 萬美元之間。請注意，這不包括 XPHOZAH 的任何預期銷售額、合作夥伴里程碑付款或產品供應收入。

In addition, the FDA approval of XPHOZAH triggered a $3 million milestone payment from Fosun, which will be recognized as revenue, and is expected to be received in this current fourth quarter.

此外，XPHOZAH 的 FDA 批准觸發了復星集團支付的 300 萬美元里程碑付款，這筆款項將被確認為收入，預計將在當前第四季度收到。

At the end of Q3, we reported year-to-date 2023 net IBSRELA sales revenue of approximately $52 million. Our raised and narrowed full year guidance range of $76 million to $78 million represents our expectation of continued consistent growth.

截至第三季末，我們報告 2023 年迄今的 IBSRELA 淨銷售收入約為 5,200 萬美元。我們上調和縮小的全年指引範圍為 7,600 萬美元至 7,800 萬美元，代表了我們對持續持續成長的預期。

We are still early in our launch and unable to fully anticipate how seasonality may play to performance during the fourth quarter, so we will continue to take a measured approach as we guided in our expected sales performance.

我們仍處於推出初期，無法完全預測季節性因素對第四季業績的影響，因此我們將繼續在預期銷售業績的指導下採取謹慎的方法。

Research and development expenses were $8.6 million for the third quarter of 2023, which is an increase of $1.1 million from the $7.5 million in the same period last year.

2023年第三季的研發費用為860萬美元，比去年同期的750萬美元增加了110萬美元。

Selling, general and administrative expenses were $32.7 million in the third quarter of 2023, an increase of $14 million from the $18.7 million we reported for the same period of 2022. The increase was due to the cost associated with the continued commercialization and growth of IBSRELA, as well as launch preparation activities for XPHOZAH.

2023 年第三季的銷售、一般和管理費用為 3,270 萬美元，比我們報告的 2022 年同期的 1,870 萬美元增加了 1,400 萬美元。這一增長是由於 IBSRELA 的持續商業化和增長相關的成本，以及啟動XPHOZAH 的準備活動。

As we mentioned during our second quarter call in August, we anticipate the costs associated with XPHOZAH would be incremental $20 million per quarter, ramping up in the third quarter, and then being fully reflected in our SG&A expenses beginning in the fourth quarter this year.

正如我們在8 月第二季電話會議中所提到的，我們預計與XPHOZAH 相關的成本每季將增加2,000 萬美元，並在第三季增加，然後從今年第四季開始充分反映在我們的SG&A費用中。

We had net income of approximately $6.6 million or $0.03 per fully diluted share in the third quarter of 2023, compared to a net loss of $22.9 million or $0.14 per share in the same period last year.

2023 年第三季度，我們的淨利潤約為 660 萬美元，即完全稀釋後每股 0.03 美元，而去年同期淨虧損為 2,290 萬美元，即每股 0.14 美元。

Our net income in the third quarter resulted in a $30 million milestone, in collaboration amendment payments from Kyowa Kirin, as well as increased sales from IBSRELA.

我們第三季的淨收入達到了 3000 萬美元的里程碑，其中包括協和麒麟 (Kyowa Kirin) 的合作修正付款以及 IBSRELA 的銷售額增加。

From a cash perspective, we have never been in a stronger financial position at the company. Let me take a step back and tell you where we are, how we got here and what it means.

從現金角度來看，我們公司的財務狀況從未如此強勁。讓我退一步告訴你我們現在在哪裡、我們是如何到達這裡以及這意味著什麼。

First, as you saw in the press release this morning, as of September 30, 2023, we had total cash, cash equivalents and short-term investments of $165.1 million, as compared to $123.9 million at the end of 2022. This reflects $58.4 million in gross proceeds that we raised during the quarter through sales of approximately 14 million shares of common stock under our ATM program at an average selling price of $4.24 per share.

首先，正如您在今天早上的新聞稿中看到的那樣，截至2023 年9 月30 日，我們的現金、現金等價物和短期投資總額為1.651 億美元，而2022 年底為1.239 億美元。這反映了5840 萬美元我們在本季透過 ATM 計劃以每股 4.24 美元的平均售價出售約 1400 萬股普通股籌集了總收益。

We also received a $2 million milestone payment from Fosun, following the submission of an NDA for tenapanor for hyperphosphatemia in China, which we announced back in July.

繼我們於 7 月宣布提交 Tenapanor 在中國治療高磷血症的 NDA 後，我們還從復星獲得了 200 萬美元的里程碑付款。

In addition to our cash as of September 30, 2023, subsequent to quarter end, there are also 3 other contributing factors that I want to point out, that significantly strengthens our cash position.

除了截至 2023 年 9 月 30 日季度末後的現金之外，我想指出的還有其他 3 個影響因素，這些因素顯著增強了我們的現金狀況。

First, we have received payment from Kyowa Kirin for the $30 million receivable, associated with the approval in Japan. Second, also associated with that approval is a $5 million milestone payment we have received from HealthCare Royalty Partners. And finally, we drew $22.5 million from our loan agreement with SLR or SLR Capital.

首先，我們已收到 Kyowa Kirin 支付的與日本批准相關的 3,000 萬美元應收帳款。其次，與該批准相關的還有我們從 HealthCareRoyalty Partners 收到的 500 萬美元里程碑付款。最後，我們從與 SLR 或 SLR Capital 的貸款協議中提取了 2,250 萬美元。

Considering these items as well as the ongoing business in October, as of yesterday, October 30, our cash and investments amounted to approximately $218.1 million. When combined with access to additional capital or option via the loan agreement with SLR, and our continued financial discipline as a company, we believe that we are very well resourced in the foreseeable future.

考慮到這些項目以及 10 月正在進行的業務，截至昨天 10 月 30 日，我們的現金和投資總額約為 2.181 億美元。結合透過與 SLR 簽訂的貸款協議獲得額外資本或選擇權，以及我們作為一家公司持續的財務紀律，我們相信在可預見的未來我們擁有非常充足的資源。

We have taken a very thoughtful, disciplined and patient approach to how we fund the company. We are positioned to support continued investments in our in-market products as well as beginning investments in our pipeline programs. We will continue to make thoughtful decisions that maximize shareholder value.

我們對公司的融資方式採取了非常深思熟慮、紀律嚴明和耐心的方法。我們準備好支持對我們的市場產品的持續投資以及對我們的管道項目的開始投資。我們將繼續做出深思熟慮的決策，以最大限度地提高股東價值。

And with that, I'll turn it back to Mike.

說到這裡，我會把它轉回給麥克。

Thanks, Justin. This is an exciting time at Ardelyx. Within a couple of weeks, we will have XPHOZAH at our distributors and ready for fulfillment to patients alongside IBSRELA. We have focused on execution this year, and yet we are not done. We have a lot of work ahead of us, continuing the momentum we've established with IBSRELA, ensuring a successful launch of XPHOZAH, and looking ahead to next year, where we will begin investing for further growth.

謝謝，賈斯汀。這是 Ardelyx 激動人心的時刻。幾週內，我們的經銷商將擁有 XPHOZAH，並準備好與 IBSRELA 一起交付給患者。今年我們的重點是執行，但我們還沒完成。我們還有很多工作要做，要繼續保持與 IBSRELA 建立的勢頭，確保 XPHOZAH 的成功推出，並展望明年，我們將開始投資以實現進一步成長。

We have shown that we can deliver on our promises. We continue to strengthen our company and our balance sheet. We are well resourced and excited about what is to come.

我們已經證明我們能夠兌現我們的承諾。我們繼續加強我們的公司和資產負債表。我們資源充足，並對即將發生的事情感到興奮。

I want to thank the members of the investment community who have been alongside us on this interesting journey. However, none of this would have been possible without the dedication, the passion and the resilience of team Ardelyx. Thank you for what you do for patients every day.

我要感謝投資界的成員，他們在這段有趣的旅程中與我們並肩作戰。然而，如果沒有 Ardelyx 團隊的奉獻、熱情和韌性，這一切都不可能實現。感謝您每天為患者所做的一切。

I will now open the call to questions. Operator?

我現在開始提問。操作員？

We will now begin the question and answer session. (Operator Instructions) The first question today comes from Louise Chen from Cantor.

我們現在開始問答環節。 （操作員說明）今天的第一個問題來自Cantor 的Louise Chen。

Congratulations on a strong quarter. I wanted to ask you, how are you thinking about gross to net for XPHOZAH?

恭喜季度表現強勁。我想問您，您對 XPHOZAH 的毛淨比有何看法？

And then also, do you think there's a bolus of patients waiting for drug, just kind of curious how you think about how fast the uptake might be, especially in the last quarter of the year? Or do you expect more of the uptake to come in the first half of 2024.

另外，您是否認為有大量患者在等待藥物，只是有點好奇您如何看待藥物的吸收速度，特別是在今年最後一個季度？或者您預計 2024 年上半年會有更多的採用。

And then last question I wanted to ask you was, obviously, you have a very strong cash position. What do you think your cash runway takes you out to?

我想問你的最後一個問題是，顯然，你擁有非常強大的現金狀況。您認為您的現金跑道會帶您去做什麼？

Yes. So let me ask Justin to address the first and last question first. And then Susan, please, about the uptake.

是的。因此，讓我先請賈斯汀解決第一個問題和最後一個問題。然後，蘇珊，請談談接受情況。

Great. Louise, regarding our gross to net for XPHOZAH, our commercial strategy will be very similar to IBSRELA, which means that we don't expect significant rebating to payers other than the statutorily required rebates to certain government payers, which would obviously have a negative effect on our gross to net.

偉大的。 Louise，關於XPHOZAH 的毛淨額，我們的商業策略將與IBSRELA 非常相似，這意味著除了法定要求的某些政府付款人回扣之外，我們預計不會向付款人提供重大回扣，這顯然會產生負面影響就我們的毛淨額而言。

But in general, we expect it to be very similar to what we saw with IBSRELA. There may be some seasonality in our gross to net, our first quarter being, perhaps, less than the other quarters due to the resetting of commercial copayment programs. But otherwise, we're very confident that it will be in -- certainly in the early years comparable to IBSRELA.

但總的來說，我們預計它與我們在 IBSRELA 中看到的非常相似。我們的毛淨額可能存在一些季節性，由於商業共付計劃的重置，我們的第一季可能少於其他季度。但除此之外，我們非常有信心它將在早期實現——當然，與 IBSRELA 相當。

And then regarding our cash position, you may see in our 10-Q, which we filed early today that we no longer have a going concern, which means our auditors are confident we have more than a year of cash. For us, we believe that it is more than that. We have enough cash runway for quite a while. We can't specifically put on because we're waiting to see how successful we are being close to launch, but we're quite confident in our cash position. Susan?

關於我們的現金狀況，您可能會在我們今天早些時候提交的 10-Q 報告中看到，我們不再持續經營，這意味著我們的審計師相信我們擁有超過一年的現金。對我們來說，我們相信它的意義遠不止於此。我們有足夠的現金跑道來維持相當長的一段時間。我們不能具體推遲，因為我們正在等待發佈時的成功程度，但我們對我們的現金狀況非常有信心。蘇珊？

Yes, Louise, regarding the uptake of XPHOZAH, you're exactly right. There is a very large group of patients today who, despite treatment with binders, are unable to consistently maintain target levels, and patients that can't tolerate binder therapy. So there's clearly a nice opportunity there. And now, these patients will have a new option with XPHOZAH.

是的，Louise，關於 XPHOZAH 的吸收，您說得完全正確。如今，有很大一部分患者儘管使用黏合劑治療，但仍無法持續維持目標水平，而且患者無法耐受黏合劑治療。所以這顯然是一個很好的機會。現在，這些患者將有了 XPHOZAH 的新選擇。

I think what's important here is thinking about the integration of novel mechanism XPHOZAH into the nephrologist prescribing pattern. How exactly they're going to integrate use of XPHOZAH across their patient group. So it's always going to take some time for the physician community to adapt their practices, now that they have an expanded treatment armamentarium.

我認為這裡重要的是考慮將新機制 XPHOZAH 整合到腎臟病專家的處方模式中。他們究竟將如何在整個患者群體中整合 XPHOZAH 的使用。因此，既然醫生界已經擁有了擴大的治療設備，那麼他們總是需要一些時間來調整他們的做法。

So given that, and given our promotional presence with nephrologists, we believe that uptake of XPHOZAH is really going to be really quite steady and consistent as they identify patients early that they believe are most in need of XPHOZAH, and then based on their experience, proceed to expand their use to those additional patients that they're quite aware today are not meeting the target levels despite binder treatment.

因此，鑑於我們與腎臟病專家的促銷活動，我們相信 XPHOZAH 的使用確實會非常穩定和一致，因為他們儘早識別出他們認為最需要 XPHOZAH 的患者，然後根據他們的經驗，繼續將其用途擴大到那些他們今天很清楚儘管進行了黏合劑治療但仍未達到目標水平的其他患者。

The next question comes from Dennis (inaudible) with Jefferies.

下一個問題來自丹尼斯（聽不清楚）和傑弗里斯。

A few questions from me. Number 1, maybe on the congressional action to delay moving orals into the bundle. Can you comment if you haven't met with the CBO, and what can you disclose from those discussions as it relates to XPHOZAH pricing? And how the $3,000 a month price would impact their cost estimates for moving orals into the bundle versus keeping them out?

我有幾個問題。第一，也許是國會採取行動推遲將口頭發言納入捆綁中。如果您還沒有與 CBO 會面，您能否發表評論？您可以從這些討論中透露哪些與 XPHOZAH 定價相關的內容？每月 3,000 美元的價格將如何影響他們將口服藥物納入捆綁銷售與將其排除在外的成本估算？

And then number 2, on the IBSRELA guidance. It seems based of off of scripts, which continue to generally grow week over week, your guidance for the year seems a little bit conservative for Q4. So is there anything you could be expecting in the quarter that investors are missing?

然後是第二點，關於 IBSRELA 指南。這似乎是基於腳本，腳本通常每週都會繼續增長，您對今年第四季的指導似乎有點保守。那麼，本季有哪些你可以期待但投資人遺漏的事情呢？

Sure, Dennis. So with any congressional action and meeting with the CBO, we don't meet with them. I've never seen that companies actually meet with the Congressional Budget Office. Any build going through Congress needs to get scored best of standard fare. So that's our expectation that's going to be happening here. Whether or not our price has an impact on that, again, that is the process that CBO goes through, and that's not something that we have transparency to.

當然，丹尼斯。因此，對於國會採取的任何行動以及與國會預算辦公室的會議，我們都不會與他們會面。我從未見過公司真正與國會預算辦公室會面。任何通過國會的建築都需要獲得最佳標準評分。這就是我們對這裡將會發生的情況的期望。無論我們的價格是否對此產生影響，這都是 CBO 所經歷的過程，而這並不是我們透明的事情。

With IBSRELA, I think is in the guidance, as Justin said, and I think as you've seen, we take a very measured approach in the way that we have certainly financed the company and the guidance that we give. We're very confident with this range, and felt that raising it the way we did and narrowing it was giving you a perspective in terms of our confidence of where IBSRELA revenue and uptake is going.

對於 IBSRELA，我認為是在指導中，正如賈斯汀所說，我認為正如你所看到的，我們採取了非常謹慎的方法，我們確實為公司提供了資金，並提供了指導。我們對此範圍非常有信心，並認為按照我們的方式提高並縮小範圍可以讓您了解我們對 IBSRELA 收入和使用情況的信心。

The next question comes from Yigal with Citi.

下一個問題來自花旗銀行的 Yigal。

On the pricing for XPHOZAH, can you just give a little more insight into the thought process around the [$2,950]. If you look at the binders, obviously, they're priced around $20,000 a year back. You're about 75%, 75% to 80% premium. Obviously, you have a very significant value proposition with the unique mechanism of actions, and we don't have anything likely in the market. But nonetheless, maybe spend a little more time discussing the thinking around that type of premium.

關於 XPHOZAH 的定價，您能否更深入地了解一下 [2,950 美元] 的思考過程。如果你看看活頁夾，很明顯，它們一年前的售價約為 20,000 美元。你大約有 75%、75% 到 80% 的溢價。顯然，你有一個非常重要的價值主張和獨特的行動機制，而我們在市場上沒有任何可能的東西。但儘管如此，也許可以花更多時間討論有關此類溢價的想法。

Sure, Yigal. I think, what you just described as the significant difference in the opportunity and the benefit that XPHOZAH will bring to patients, that's really the differentiator here. It's looking at what we're thinking is the best thing and what's most appropriate for patients, especially in the context of other branded binders within the marketplace.

當然，伊格爾。我認為，您剛才所描述的 XPHOZAH 將為患者帶來的機會和利益的顯著差異，這確實是這裡的差異化因素。它著眼於我們認為最好的東西以及最適合患者的東西，特別是在市場上其他品牌黏合劑的背景下。

So we're very comfortable with where we've landed, and think the price is exactly where it needs to be, and it's appropriate for the patients and what we are going to be bringing for them.

因此，我們對我們的目標感到非常滿意，並認為價格正是需要的，並且適合患者以及我們將為他們帶來的東西。

And then maybe for Susan. Susan, if you could talk a little bit more about IBSRELA, (inaudible), but could you tell us what the refill rate is, and the number of scripts per writer so far, if that's data you have access to?

然後也許是蘇珊。 Susan，如果您能多談談 IBSRELA（聽不清楚），但是您能否告訴我們補充率是多少，以及到目前為止每個作者的腳本數量（如果這是您可以訪問的數據）？

Yes. Yes, we track that closely. We have not specifically disclosed those growth rates. But what I can tell you is that the refill rates are growing at comparable or greater than the new Rx rate. So both are showing very healthy growth, and that has been persistent. So reflecting that physicians are continuing to write new scripts for patients. And when those scripts are written, they're getting refilled. So it's very encouraging, looking at those rates.

是的。是的，我們密切跟踪。我們沒有具體披露這些成長率。但我可以告訴您的是，補充率的成長速度與新的治療率相當或更高。因此，兩者都表現出非常健康的增長，而且這種增長一直持續。這反映出醫生們正在繼續為患者編寫新的治療方案。當這些腳本寫完後，它們就會被重新填充。因此，看看這些比率，這是非常令人鼓舞的。

And in terms of the average script per writer, again, it's not a specific metric we have disclosed, but we track that very closely. And what's really encouraging is that every single month, we see a new cohort of writers joining the IBSRELA writing group. So we're persistently accumulating writers. And when you track existing writers, monthly on a persistent level, they're increasing their prescription volume for IBSRELA. So all of those fundamental demand indicators continue to be very strong.

就每個作家的平均劇本而言，這並不是我們披露的具體指標，但我們非常密切地追蹤它。真正令人鼓舞的是，每個月我們都會看到一群新作家加入 IBSRELA 寫作小組。所以我們一直在累積作家。當你每月持續追蹤現有的作家時，他們正在增加 IBSRELA 的處方量。因此，所有這些基本需求指標仍然非常強勁。

Okay. And then one quick one for Justin on the tax and the finances. Obviously, you highlighted a very strong cash position as of yesterday. I'm just curious, you also mentioned that you did report positive net income, although I know that these are driven by, perhaps, some onetime items. But nonetheless, I'm just curious, Justin, if you could kind of give us a sense as to the likelihood that you might need to take -- use the SLR credit line again? Or is that more of a backup plan, and it's not really something you're expecting to be done again?

好的。然後賈斯汀快速了解一下稅務和財務問題。顯然，您強調了截至昨天的現金狀況非常強勁。我只是好奇，你也提到你確實報告了正的淨利潤，儘管我知道這些可能是由一些一次性項目驅動的。但儘管如此，我只是很好奇，賈斯汀，您能否讓我們了解一下您可能需要再次使用 SLR 信用額度的可能性？或者這更像是一個後備計劃，而您實際上並不希望再次這樣做？

I'm sorry, I had trouble understanding the second part of your question. You asked about our cash runway because there was onetime items?

抱歉，我無法理解您問題的第二部分。您詢問我們的現金跑道是因為有一次性物品嗎？

And then whether we'd be accessing the credit that we have or financing the company in the future, how's that?

然後我們是否會在未來獲得現有的信貸或為公司提供融資，情況如何？

Yes. So we're very pleased with our third quarter. We're clearly not in a point yet where we can share where breakeven is, but we take a very measured approach to our funding, as you've seen. I do think with our internal projections, we can be very flexible and patient. We have until March 15 of next year to potentially draw the next tranche of debt.

是的。所以我們對第三季非常滿意。顯然，我們還沒有達到可以分享損益平衡的程度，但正如您所看到的，我們對融資採取了非常謹慎的方法。我確實認為，根據我們的內部預測，我們可以非常靈活和耐心。我們必須在明年 3 月 15 日之前提取下一批債務。

And so that's something that, as the team, we'll evaluate as we see how well XPHOZAH launches, and the continued growth of IBSRELA. So it's something that we want to have the flexibility on. We don't have any intentions to do a significant equity raise this time. We're always looking at all of our different ways to raise capital when appropriate.

因此，作為一個團隊，我們將在看到 XPHOZAH 的推出效果以及 IBSRELA 的持續成長時進行評估。所以我們希望在這方面具有靈活性。這次我們無意進行重大股權融資。我們一直在尋找各種不同的方式來在適當的時候籌集資金。

Yes. And Yigal, what I'd add to that is SLR has been a spectacular and unique partner in this whole process for us, right? I mean, you think about when we first established a relationship with them, the company was in a very different position.

是的。 Yigal，我要補充的是，SLR 在整個過程中一直是我們出色且獨特的合作夥伴，對吧？我的意思是，你想想當我們第一次與他們建立關係時，公司處於一個非常不同的位置。

And the terms around this loan are really favorable to us and what we're able to accomplish with it, which is why we drew down the 22.5%. The additional 50 at our discretion is nice to have. And we may, at some point in the future, take that down before the time frame that Justin just mentioned. But I think it's important that we have taken the approach that we have, and have strong partners like SLR to grow the company to where we want it to be.

這筆貸款的條款對我們以及我們能夠利用它實現的目標非常有利，這就是我們提取 22.5% 的原因。我們自行決定的額外 50 個是很好的。我們可能會在未來的某個時候，在賈斯汀剛才提到的時間範圍之前將其刪除。但我認為重要的是，我們必須採取現有的方法，並擁有像 SLR 這樣強大的合作夥伴，才能將公司發展到我們想要的目標。

The next question comes from Ed Arce with H.C. Wainright.

下一個問題來自 Ed Arce 和 H.C.溫賴特。

Congrats on the approval and the quarter. First, I wanted to ask about IBSRELA, given the guidance -- the new guidance range. If you could discuss sort of what you're continuing to see as drivers of additional uptake, both with new and existing writers.

恭喜您獲得批准並進入本季。首先，我想詢問 IBSRELA 的情況，以及新的指導範圍。您是否可以與新作家和現有作家討論一下您認為繼續增加閱讀量的驅動因素。

And then, turning to XPHOZAH. I'm wondering if, with initial sales in the fourth quarter, are you expecting to report quarterly metrics, say, fourth quarter or early next year, and sort of disclosing those and tracking those beyond scripts?

然後，轉向 XPHOZAH。我想知道，隨著第四季度的首次銷售，您是否期望報告季度指標，例如第四季度或明年初，並披露這些指標並追蹤腳本之外的指標？

And then finally on pricing, I know this was already brought off, but I wanted to ask how you came to that number as you think about balancing the ability to capture the differentiated value proposition with the patient access and affordability that you've mentioned is important for your launch?

最後在定價方面，我知道這已經實現了，但我想問一下，當您考慮平衡捕捉差異化價值主張的能力與您提到的患者訪問和負擔能力時，您是如何得出這個數字的對您的發布很重要嗎？

Sure. Let me make a couple of comments on all of those, Ed. Thank you for the question. And then I'll ask Susan to address all of them as well.

當然。讓我對所有這些發表一些評論，埃德。感謝你的提問。然後我也會請蘇珊對所有這些問題發表演說。

So the IBSRELA uptake dynamic, it's because the drug works, right? It is something that people are getting the samples and then their first prescription and the drug is doing something that they've never experienced before with the products that they've previously been utilizing. So that's really what's driving us, it's the experience is positive.

所以 IBSRELA 的吸收動態是因為藥物有效，對嗎？人們拿到樣品，然後開出第一個處方，藥物正在發揮他們以前使用過的產品從未經歷過的作用。這就是我們的動力，這種體驗是正面的。

And ArdelyxAssist program that facilitates access is extraordinarily important and a hallmark of what we do and the way that we help patients get access to the drugs that we develop.

促進獲取的 ArdelyxAssist 計劃非常重要，也是我們所做工作以及幫助患者獲取我們開發的藥物的方式的標誌。

With XPHOZAH metrics, we'd love to provide as much as we can, but we'll provide what we think is appropriate. Early in the launch, we want to make sure that as we did with IBSRELA, it's probably 4 to 5 quarters of these questions being asked and that we'll do the best to answer them before we're giving more solid metrics as we see as things evolve.

對於 XPHOZAH 指標，我們很樂意提供盡可能多的信息，但我們會提供我們認為合適的內容。在發布初期，我們希望確保，就像我們對IBSRELA 所做的那樣，可能有4 到5 個季度的問題被問到，並且我們將盡力回答這些問題，然後再提供我們所看到的更可靠的指標隨著事情的發展。

And with pricing, pricing is an art as well as a science. I think, what we have done here given the expansiveness of the entirety of what we do for patients, that this is a completely appropriate price for what this drug brings because there are no other drugs to manage phosphorus that our next line opportunities with a novel mechanism that may very well be the way that we can ultimately get a greater percentage of our patients to goal.

對定價來說，定價既是一門藝術，也是一門科學。我認為，考慮到我們為患者所做的全部工作的廣泛性，我們在這裡所做的事情對於這種藥物帶來的價格是完全合適的，因為沒有其他藥物可以控制磷，我們的下一條線有機會用一種新型藥物來控制磷。這種機制很可能是我們最終能夠讓更多患者實現目標的方式。

And that's what we should all be focused on is that we, with this approval and the field force out there already, next -- this week, with ASN is going to be spectacular. And we're all going to learn a lot about this together. And we feel very confident that we have prices appropriately and are going to be reflecting that in uptake over the ensuing quarters that we were together talking about this.

這就是我們大家應該關注的重點，在獲得批准和現場力量的支持下，下週——ASN 將會非常壯觀。我們將一起學習很多這方面的知識。我們非常有信心，我們有適當的價格，並將在接下來的幾個季度中反映出我們共同討論的這一點。

Susan, would you like to add anything?

蘇珊，你想補充什麼嗎？

Yes, thanks Mike. I think in terms of -- let me take the IBSRELA aspect of your question first, and then touch on the XPHOZAH pricing.

是的，謝謝邁克。我認為，讓我先考慮您問題的 IBSRELA 方面，然後再談談 XPHOZAH 定價。

I think for IBSRELA, what we're finding is -- I mean, there are many high-writing physicians who are just beginning to prescribe IBSRELA. And as we get in their offices with the frequency and the sampling, we continue to bring on more and more new writers. So that's really -- there is a lot of runway there. We continue to bring on new writers for IBSRELA. And then as I mentioned before, on top of that, the existing writers expanding their use across their patient population.

我認為對於 IBSRELA，我們發現的是——我的意思是，有許多高水平的醫生剛開始開 IBSRELA 處方。隨著我們進入他們的辦公室的頻率和抽樣，我們繼續引進越來越多的新作家。所以那確實是——那裡有很多跑道。我們繼續為 IBSRELA 引進新的作家。然後，正如我之前提到的，最重要的是，現有的作者將其用途擴大到患者群體。

And what we're finding, even at the third dimension is the growth driver is, as they gain the favorable experience with IBSRELA, they're expanding their view as they see patients daily in their office on patients who could benefit from IBSRELA. So we have very, very strong growth dimensions there in view for IBSRELA taking us into the future.

我們發現，即使在第三個維度，成長動力是，隨著他們獲得 IBSRELA 的良好體驗，他們每天在辦公室看到患者，了解可以從 IBSRELA 受益的患者，從而擴大了自己的視野。因此，我們有非常非常強勁的成長空間，IBSRELA 將帶領我們走向未來。

I think in terms of XPHOZAH pricing, as Mike mentioned, we consider multiple dynamics. Let's just talk a little bit about -- obviously, we talked about the novelty of the drug, the unmet need and our commitment to patient access. If you look at the CKD pricing landscape, there have been a few innovations launched recently, which is really encouraging for CKD patients on dialysis in high unmet need areas like nephropathy, IgA nephropathy, lupus nephritis, those products price in the range depending on -- which one, depending to $4,000 to $10,000 a month.

我認為就 XPHOZAH 定價而言，正如麥克所提到的，我們考慮了多種動態。讓我們簡單談談——顯然，我們討論了藥物的新穎性、未滿足的需求以及我們對患者使用的承諾。如果你看看CKD 的定價格局，你會發現最近推出了一些創新，這對於在腎病、IgA 腎病、狼瘡性腎炎等高未滿足需求領域接受透析的CKD 患者來說確實令人鼓舞，這些產品的價格範圍取決於 - - 哪一個，取決於每月 4,000 美元到 10,000 美元。

If you look at specifically hyperphosphatemia, I know Yigal had mentioned the branded pricing of the product. If you look at the number of cases that you're on, and it appears on which product they're on, the expense of granted binders is actually distributed across a pretty broad range, which ranges from $1,400 a month to, as we estimate around $2,400 a month.

如果你特別關注高磷酸鹽血症，我知道 Yigal 提到了該產品的品牌定價。如果您查看您所處理的案件數量，並查看它們所處理的產品，您會發現授予活頁夾的費用實際上分佈在相當廣泛的範圍內，範圍從每月1,400 美元到我們估計的1,400 美元不等。每月約2,400美元。

So in that context, to consider the overall CKD pricing landscape, the hyperphosphatemia branded binder range of cost per month, the novel innovation that XPHOZAH represents, we believe that it's an appropriate price point.

因此，在這種背景下，考慮到整體 CKD 定價格局、高磷血症品牌黏合劑每月的成本範圍、XPHOZAH 所代表的新穎創新，我們認為這是一個合適的價格點。

You had mentioned the commitment to access, Mike has emphasized this, both for IBSRELA and XPHOZAH, we are quite confident with the program we have in place that we're going to support the nephrology offices with this prior-authorization submissions so patients can gain access to XPHOZAH, and that XPHOZAH will be affordable, either because we can offset their co-pay for commercial patients. And for patients who can't afford the product, too, who don't have local pay program, they would be eligible for our patient assistance program.

您提到了訪問承諾，Mike 強調了這一點，對於 IBSRELA 和 XPHOZAH，我們對我們現有的計劃非常有信心，我們將通過預先授權提交來支持腎臟病辦公室，以便患者能夠獲得獲得XPHOZAH，並且XPHOZAH 將是負擔得起的，因為我們可以抵消他們對商業患者的自付費用。對於買不起該產品、沒有當地支付計劃的患者，他們將有資格參加我們的患者援助計劃。

So access and affordability really is our primary focus, and that's what's going to be important to bring XPHOZAH to these patients.

因此，取得和負擔能力確實是我們的首要關注點，這也是將 XPHOZAH 帶給這些患者的重要因素。

Next question comes from Joseph Thome with TD Cowen.

下一個問題來自 Joseph Thome 和 TD Cowen。

Maybe the 2 on IBSRELA uptake. I guess, are you seeing physicians -- obviously, the drug is launching well. Are you seeing physicians want to use the drug earlier in the treatment line of their patients? Or obviously, we talked about the target, post the (inaudible) market. But are you seeing them want to use it earlier?

也許 IBSRELA 的吸收率是 2。我想，你有去看醫生嗎——顯然，這種藥物的上市進展順利。您是否看到醫生希望在患者的治療過程中更早使用該藥物？或者顯然，我們討論了目標，即（聽不清楚）市場後的目標。但您是否看到他們想早點使用它？

And then second, we did see the Phase III trial in adolescent patients. I guess, what is the current uptake in adolescent patients between 12 and, I guess, 17, 18 years of age? And what's sort of the eventual goal of this study? Would it be just to remove that line on the label that said safety and efficacy of the drug aren't available in pediatric patients as of 18? Or is there something else that can be done with it -- out of the study readout?

其次，我們確實看到了青少年患者的 III 期試驗。我猜，12 歲到 17、18 歲之間的青少年患者目前的接受度是多少？這項研究的最終目標是什麼？難道只是刪除標籤上的一行字，說明該藥物自 18 歲起在兒童患者中無法獲得安全性和有效性嗎？或者除了研究讀數之外，還有其他可以用它來做的事情嗎？

Sure. And I'll ask Susan to speak to the IBSRELA uptake. But first, let me address the pediatric adolescent question. That was an interim look at some of the data that was presented. We are still indicated only for adults with IBS-C. So that hasn't changed. So any insights that we have, I can't think of any that say that we're treating adolescents because that's not indicated in our label nor is first-line therapy, right?

當然。我將請 Susan 談談 IBSRELA 的採用情況。但首先，讓我解決一下兒科青少年的問題。這是對所提供的一些數據的臨時觀察。我們仍然僅適用於患有 IBS-C 的成人。所以這並沒有改變。因此，我想不出我們正在治療青少年的任何見解，因為我們的標籤中沒有表明這一點，一線治療也沒有表明，對嗎？

I mean if you look at the way that we position this, it is a drug that's going to be used for patients that are no longer responding to the GCC agonist. Specific feedback as to whether or not people are using it earlier, Susan, do you want to address that?

我的意思是，如果你看看我們的定位方式，你會發現這是一種將用於不再對 GCC 激動劑產生反應的患者的藥物。關於人們是否更早使用它的具體回饋，蘇珊，你想解決這個問題嗎？

Yes. Actually, it's interesting for -- if you recall, we have a very focused approach calling on the highest writing physicians for IBS-C indicated prescription. For those physicians, the patients they see in their office is daily, have all been cycled -- have cycled through GCC agonist. So very important to think about the context on where we're focused with IBSRELA.

是的。事實上，如果你還記得的話，這很有趣，我們有一個非常集中的方法，呼籲最高級別的醫生撰寫 IBS-C 指示處方。對於那些醫生來說，他們每天在辦公室見到的患者都已經接受過循環治療——已經接受過 GCC 激動劑的循環治療。因此，考慮我們關注 IBSRELA 的背景非常重要。

So for those physicians, patient they see daily, typically have already been treated with these products. So it depends on how you define early. What we're finding is that, because the patients meet already the prior authorization criteria, it's really the physician's eagerness in identifying increasingly patients that they believe can benefit from a novel option.

因此，對於那些醫生來說，他們每天見到的患者通常已經接受過這些產品的治療。所以這取決於你早期如何定義。我們發現，由於患者已經滿足事先授權標準，因此醫生確實渴望識別越來越多的患者，他們認為這些患者可以從新的選擇中受益。

Remember that the overall label for IBSRELA does support (inaudible), but in our case, focusing on these high-writing physicians, it's really not an issue for the patients who walk into their office every day meet the prior of criteria.

請記住，IBSRELA 的整體標籤確實支持（聽不清楚），但在我們的案例中，重點關注這些高水平的醫生，對於每天走進辦公室的滿足先驗標準的患者來說，這實際上不是問題。

The next question comes from Matt Kaplan with Ladenburg Thalmann.

下一個問題來自馬特·卡普蘭和拉登堡·塔爾曼。

Congrats on the strong quarter. Just focusing on IBSRELA a little bit. Maybe Susan, can you talk about how patients are using IBSRELA in a real-world setting now versus the use in the long-term clinical studies?

恭喜季度表現強勁。只要稍微關心一下 IBSRELA。也許 Susan，您能談談患者現在在現實環境中使用 IBSRELA 與在長期臨床研究中的使用情況如何嗎？

Yes, Matt. Actually, what we're finding, I mean our clinical data package really shows a rapid response to IBSRELA and a sustained response to IBSRELA, which is really a piece of our overall product profile and clinical data profile that physicians respond very favorably to. And what we're finding in the real world is that, that has been their experience that patients have responded to IBSRELA. And when they respond to IBSRELA, they continue to have a sustained effect.

是的，馬特。實際上，我們的發現是，我們的臨床數據包確實顯示了對 IBSRELA 的快速反應和對 IBSRELA 的持續反應，這確實是我們整體產品概況和臨床數據概況的一部分，醫生對此反應非常積極。我們在現實世界中發現的是，這是他們的經驗，患者對 IBSRELA 有反應。當他們對 IBSRELA 做出反應時，他們會繼續產生持續的效果。

I mean obviously, you're not going -- it's not going to be the best -- the right drug for every single patient, but where -- the physician feedback really has been quite favorable on their treatment experience, consistent with their expectations based on the clinical data package. And (inaudible) has been tracking the launch over time, and persistently they're reporting either moderate or high satisfaction with treatment with IBSRELA and reporting low discontinuation rate.

我的意思是，顯然，你不會——這不會是最好的——適合每個患者的正確藥物，但是，醫生的反饋確實對他們的治療體驗非常有利，與他們的期望一致。臨床數據包上。並且（聽不清楚）隨著時間的推移一直在追蹤發布，並且持續報告對 IBSRELA 治療的中等或高度滿意度，並報告較低的停藥率。

All right. And then I guess, given the similarities between the IBS-C market and hyperphosphatemia market, in terms of going into these 2 markets with a novel mechanism of action, combined with the unmet need. Can you talk a little bit about the learnings that you've had in the launch of IBSRELA that you're going to apply to XPHOZAH?

好的。然後我想，考慮到 IBS-C 市場和高磷血症市場之間的相似性，以新穎的作用機制進入這兩個市場，並結合未滿足的需求。您能否談談您在推出 IBSRELA 過程中學到的知識並將其應用到 XPHOZAH 中？

Sure, Matt. Susan, please.

當然，馬特。蘇珊，請。

Yes. So yes, you're spot on in terms of the parallels between the 2 markets. And a very important learning is the physician interest, because of the limited options that they have had and the recognized unmet need, their interest in the novel mechanism profile, understanding the way the drug works uniquely and its clinical data package. So we're very much science-based, clinical-based cells, patient-based cell. And also learn the criticality of emphasizing our commitment to patient access and affordability.

是的。所以，是的，您對這兩個市場之間的相似之處是完全了解的。一個非常重要的學習是醫生的興趣，因為他們擁有的選擇有限，並且認識到未滿足的需求，他們對新穎的機制概況、了解藥物獨特的工作方式及其臨床數據包感興趣。所以我們是非常以科學為基礎、以臨床為基礎的細胞、以病人為基礎的細胞。也要了解強調我們對病人獲取和負擔能力的承諾的重要性。

So physicians, really, they prescribe based on patients needing a drug, and it's important that we encourage them that they do not have to have a concern around the prior authorization process, that we can support that. We can remind them that they have familiarity with that administrative process with other drugs they write, and this one is no different.

因此，醫生實際上是根據需要藥物的患者開藥，重要的是我們鼓勵他們不必擔心事先授權過程，我們可以支持這一點。我們可以提醒他們，他們熟悉自己編寫的其他藥物的管理流程，這種藥物也不例外。

And in this case, the patients that they're identifying, who are in need of our novel drug implicitly meet the prior authorization criteria. So all of that will be very critical in really supporting physician uptake, integrating novel mechanism XPHOZAH into their treatment patterns for these patients who have, for so long, have had no options outside of binders.

在這種情況下，他們正在識別的需要我們的新藥的患者隱含地滿足事先的授權標準。因此，所有這些對於真正支持醫生的採用，將新機制 XPHOZAH 整合到他們的治療模式中，對於長期以來除了黏合劑之外別無選擇的患者來說，都是非常關鍵的。

And Matt, what I would add to that is the power of ArdelyxAssist and the comprehensiveness of that program, when physicians utilize it in a way that it's been designed, I think they find an extraordinarily seamless program where they get confidence that if they're going to write a script, that their patient is going to get it, irrespective of whether or not it's a co-pay paydown, it's an affordability issue, Medicaid, Medicare, Ardelyx is there to accomplish an awful lot.

馬特，我要補充的是 ArdelyxAssist 的強大功能和該程序的全面性，當醫生按照設計的方式使用它時，我認為他們會發現一個非常無縫的程序，他們可以確信，如果他們寫一個腳本，讓他們的病人能夠得到它，不管它是否是共同支付的付款，這是一個負擔能力問題，醫療補助、醫療保險、Ardelyx 可以完成很多工作。

So it's really the -- that program and how physicians and ultimately the patients who are receiving, whether it's IBSRELA or XPHOZAH are finding that ArdelyxAssist is really doing the job that it's been designed to do.

所以，這確實是一個項目，以及醫生和最終接受治療的患者（無論是 IBSRELA 還是 XPHOZAH）如何發現 ArdelyxAssist 確實在完成其設計目的的工作。

Okay. Great. Great. And then last question. Can you provide a little bit more detail on the presence that you're going to have at the upcoming ASN meeting later this week?

好的。偉大的。偉大的。然後是最後一個問題。您能否提供更多有關您將出席本週稍後舉行的 ASN 會議的詳細資訊？

Sure, Susan?

當然可以，蘇珊？

Yes. So we will have a very strong presence for XPHOZAH at the upcoming ASN meeting. We will have a strong promotional booth presence, reflecting our whole launch campaign for XPHOZAH. As we mentioned earlier in the narrative, we have a sales force out and deployed calling on nephrology health care providers as we speak. So we'll have a strong promotional presence at ASN.

是的。因此，我們將在即將舉行的 ASN 會議上大力展示 XPHOZAH。我們將有一個強大的促銷展位，反映我們的 XPHOZAH 整個推出活動。正如我們在前面的敘述中提到的，我們已經派出了一支銷售隊伍，並在我們講話時呼叫腎臟病醫療保健提供者。因此，我們將在 ASN 上進行強有力的促銷活動。

Reminder at banners, I think anywhere you look across the ASN floor, you're going to see XPHOZAH and its novel blocking mechanism campaign. We also have a clinical scientific presence at ASN, we'll have a product theater where we have opinion leaders presenting on the novel product profile of XPHOZAH and its clinical data package. So we're quite encouraged about all of the events at ASN, and hopefully, look forward to seeing you there.

橫幅提醒，我想無論你在 ASN 地板上的任何地方，你都會看到 XPHOZAH 及其新穎的阻止機制活動。我們也在 ASN 上設有臨床科學部門，我們將擁有一個產品劇場，意見領袖將在其中介紹 XPHOZAH 的新穎產品簡介及其臨床資料包。因此，我們對 ASN 上的所有活動感到非常鼓舞，並希望期待在那裡見到您。

The next question comes from Laura Chico with Wedbush Securities.

下一個問題來自 Wedbush Securities 的 Laura Chico。

This is Ingrid on for Laura Chico. How should we be thinking about gross to net dynamics for exposure pricing over time? And what your steady-state rate expectations for gross to net discount? And then just our last question is, could you perhaps review why IBSRELA, as a competitor, makes sense?

這是勞拉·奇科 (Laura Chico) 的英格麗 (Ingrid)。我們應該如何考慮暴露定價隨時間的總淨動態變化？您對毛淨折扣的穩態利率預期是多少？我們的最後一個問題是，您能否回顧為什麼 IBSRELA 作為競爭對手有意義？

Let me start with the last one first. It's a great question, is why does IBSRELA as a competitor makes sense? I think Susan is the best one to address that, given what the experiences Ardelyx -- we're seeing in the field. And then I'll ask Justin to address gross net for XPHOZAH and discounts. Susan?

讓我先從最後一個開始。這是一個很好的問題，為什麼 IBSRELA 作為競爭對手有意義？考慮到我們在現場看到的 Ardelyx 的經歷，我認為 Susan 是解決這個問題的最佳人選。然後我會請賈斯汀解決 XPHOZAH 的總淨值和折扣問題。蘇珊？

Yes. So I think IBSRELA as a competitor, let's just take a step back, and I think it's some of the parallels that Matt alluded to.

是的。所以我認為 IBSRELA 作為競爭對手，讓我們退後一步，我認為這是馬特提到的一些相似之處。

So as a novel mechanism drug, a specialty drug, the gross to net components, take into account the distribution, the mandated government rebates and other considerations that Justin can touch on. Overall, (technical difficulty) between the 2 products, we're going to need to wait and see because the mix of patients -- the payer mix of patients also determines the extent to which the government mandated rebates become a part of your gross to net profile.

因此，作為一種新機制藥物、一種特殊藥物，從總成分到淨成分，要考慮到分配、政府強制回扣以及賈斯汀可以觸及的其他考慮因素。總的來說，這兩種產品之間的（技術難度），我們需要等等看，因為患者的組合——患者的付款人組合也決定了政府規定的回扣在多大程度上成為您總收入的一部分。網路設定檔。

But what is comparable between the 2, which is an important comparator, is that there will not be incremental rebates that we're providing payers for access to the drug. Access to the drug will be achieved by a prior authorization because for these patients, in both cases, they have limited options and physician prescribing our novel mechanism drug is because those options have not been adequate and they're in need of a new option.

但這兩者之間的可比性（這是一個重要的比較器）是，我們不會為支付者提供獲得該藥物的增量回扣。獲得該藥物將透過事先授權來實現，因為對於這些患者來說，在這兩種情況下，他們的選擇都是有限的，醫生開出我們的新機制藥物是因為這些選擇不夠充分，他們需要新的選擇。

So that's how patients will access our drug. And therefore, there will not be the incremental payer rebate gross to net item, which we get a lot of questions on that because I think for product launches, those are rebates that are negotiated over time, so they start to integrate themselves into your gross to net profile. That is one item that we can tell you today, is not going to be something that's going to show up on the profile for either product.

這就是患者獲得我們藥物的方式。因此，不會有增量付款人回扣毛額與淨額的比，我們對此有很多疑問，因為我認為對於產品發布，這些回扣是隨著時間的推移而協商的，因此它們開始將自己融入到您的毛額中到網路設定檔。這是我們今天可以告訴您的一項，不會出現在任一產品的設定檔中。

Just to follow up on the question, were you asking about the financial comparator or the clinical comparison to other drugs in the market?

只是為了跟進這個問題，您是在詢問財務比較還是與市場上其他藥物的臨床比較？

Financial comparator.

財務比較器。

Great. Justin, do you want to address those net for XPHOZAH and discounting?

偉大的。 Justin，您想向這些網路發送 XPHOZAH 和折扣嗎？

Sure. Susan briefly touched on it now, but just to elaborate. The most important thing for us is access and making sure the patients have access to it. And so our commercial strategy will be very similar to what we did with IBSRELA, which means, as Susan mentioned, we don't do significant rebating the payers, but we will have our same generous commercial co-pay, commercial buydown process, where if you have commercial coverage, we will take care of your co-pay to 100%. And so as a result, we may expect to see the seasonality that we saw with IBSRELA, where in the first quarter of the year, when many patients plans reset, there may be deductibles where we will help the patient meet that need, and then it may improve, if you will, over the course of the following subsequent quarters.

當然。蘇珊現在簡單地談到了這一點，但只是為了詳細說明。對我們來說最重要的是訪問並確保患者能夠訪問它。因此，我們的商業策略將與我們對IBSRELA 所做的非常相似，這意味著，正如Susan 所提到的，我們不會對付款人進行大量回扣，但我們將擁有同樣慷慨的商業共同支付、商業買斷流程，其中如果您有商業保險，我們將承擔您 100% 的自付費用。因此，我們可能會看到 IBSRELA 的季節性，即在今年第一季度，當許多患者計劃重置時，可能會有免賠額，我們將幫助患者滿足該需求，然後如果你願意的話，它可能會在接下來的幾個季度中得到改善。

So as a general premise, with IBSRELA, as you may have seen, our first quarter was just about 33%, and it's come down into the high 20s over the course of this year. And I think it's fair to say, at least initially, we expect similar gross to net margins for XPHOZAH.

因此，作為一般前提，對於 IBSRELA，正如您可能已經看到的那樣，我們第一季的比例僅為 33% 左右，而今年這一數字已降至 20% 左右。我認為可以公平地說，至少在最初，我們預計 XPHOZAH 的毛利率與淨利潤率相似。

This concludes our question-and-answer session. I would like to turn the conference back over to President and CEO, Mike Raab, for any closing remarks.

我們的問答環節到此結束。我想將會議轉回總裁兼執行長 Mike Raab 發表閉幕詞。

Thank you, everyone, for joining us this morning. Before I close the call, I want to recognize a member of the kidney community who we recently lost, Derek Forfang.

謝謝大家今天早上加入我們。在結束通話之前，我想向我們最近失去的一位腎臟界成員表示認可，他就是德里克·福方 (Derek Forfang)。

Derek was an incredible person and patient advocate who meant so much to so many people in the kidney community and beyond.

德里克（Derek）是一位令人難以置信的人和患者的倡導者，他對腎臟界內外的許多人來說意義重大。

For Ardelyx, Derek brought the patient voice to Ardelyx Scientific Advisory Board, and was the driving force behind the creation of the Ardelyx Patient Advisory Council.

對於 Ardelyx，Derek 將患者的聲音帶到了 Ardelyx 科學諮詢委員會，並且是創建 Ardelyx 患者諮詢委員會的推動力。

Derek was a warrior, who, despite his many health challenges, always persevered, put others first, and continued his mission to advocate for kidney patients with a smile.

德里克是一位戰士，儘管面臨許多健康挑戰，但他始終堅持不懈，將他人放在第一位，並微笑著繼續他為腎病患者辯護的使命。

Derek's passing is a reminder to all of us that our job is not done. There are so many patients with CKD who need innovation. And we need to continue investing in and developing innovations with urgency for this community of patients. With that, we can close the call. Thank you, operator.

德里克的去世提醒我們所有人，我們的工作尚未完成。有這麼多的 CKD 患者需要創新。我們需要繼續為這個患者群體緊急投資和開發創新。這樣，我們就可以結束通話了。謝謝你，接線生。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。