Ardelyx Inc (ARDX) 2025 Q1 法說會逐字稿

Good day, everyone, and welcome to the Ardelyx first quarter 2025 earnings call. (Operator Instructions)

大家好，歡迎參加 Ardelyx 2025 年第一季財報電話會議。（操作員指示）

Now, I'd like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations. Caitlin, you may begin.

現在，我想將會議交給企業傳播和投資者關係副總裁凱特琳·洛伊 (Caitlin Lowie)。凱特琳，你可以開始了。

Thank you. Good afternoon, and welcome to our first quarter 2025 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。下午好，歡迎參加我們的 2025 年第一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 的投資者部分查閱。

During this call, we'll be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ significantly from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q, those 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，我們將做出具有風險和不確定性的前瞻性陳述。我們的實際結果可能與所描述的結果有很大差異。我們建議您查閱我們最新季度報告中的10-Q表格中的風險因素，該報告已於今日提交，並可在我們的網站ardelyx.com上查閱。雖然我們未來可能會選擇更新這些前瞻性陳述，但我們明確聲明，即使我們的觀點發生變化，我們也不承擔任何更新義務。

Our President and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's performance during the first quarter of 2025. Next, Chief Commercial Officer, Eric Foster, will provide an update on the performance of IBSRELA and XPHOZAH. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the first quarter ended March 31, 2025, before we open the call to questions.

我們的總裁兼執行長 Mike Raab 將在今天的電話會議上致開幕詞並概述公司 2025 年第一季的業績。接下來，首席商務長 Eric Foster 將介紹 IBSRELA 和 XPHOZAH 的最新業績。在我們開始提問之前，財務和營運長賈斯汀·倫茨 (Justin Renz) 將在今天的準備好的演講結束時回顧公司截至 2025 年 3 月 31 日的第一季度的財務業績。

With that, I'll hand the call over to Mike.

說完這些，我就把電話交給麥克。

Good afternoon, and thank you for joining us today. We're pleased to share an outstanding start to the year at Ardelyx. We've made excellent progress across all of our priorities and continue to build significant momentum while navigating a rapidly changing and dynamic marketplace.

下午好，感謝您今天加入我們。我們很高興與大家分享 Ardelyx 今年的出色開端。我們在所有優先事項上都取得了優異的進展，並在快速變化和充滿活力的市場中繼續保持強勁發展勢頭。

As compared to the same period last year, we generated revenue growth of 61%, totaling $74 million. This is noteworthy. Our teams are building clinical conviction for our therapies and serving more and more patients with these two important therapeutic options. We've successfully launched two products during the last three years and we're delivering on our mission.

與去年同期相比，我們的營收成長了 61%，達到 7,400 萬美元。這是值得注意的。我們的團隊正在為我們的療法建立臨床信心，並透過這兩種重要的治療選擇為越來越多的患者提供服務。在過去三年中，我們成功推出了兩款產品，並且正在履行我們的使命。

Now, starting with IBSRELA. IBSRELA's exciting growth trajectory continues. We delivered one of the highest prescription demand quarters to date during the first quarter, reinforcing our confidence in IBSRELA as a differentiated, important, and valuable treatment for patients.

現在，從 IBSRELA 開始。IBSRELA 令人興奮的成長軌跡仍在繼續。我們在第一季實現了迄今為止處方需求最高的季度之一，這增強了我們對 IBSRELA 作為一種對患者俱有差異化、重要性和價值的治療方法的信心。

IBSRELA's significant long-term potential is supported by a large and growing market and continued unmet need among patients remain inadequately served by secretagogues. Our commercial team is effectively driving prescriber adoption by building clinical conviction among high value targets, while our expanded field access management team is enhancing patient access and pull through.

IBSRELA 的巨大長期潛力受到龐大且不斷增長的市場以及促泌劑無法充分滿足的患者未滿足需求的支持。我們的商業團隊透過在高價值目標中建立臨床信念來有效地推動處方者的採用，而我們擴大的現場訪問管理團隊正在增強患者的訪問和通過。

Together, these efforts are positioning the drill for sustained growth and deeper market penetration. We are on track to meet our 2025 guidance of $240 million to $250 million in net sales, and we have a clear path to achieving peak annual net sales revenue of over $1 billion.

這些努力共同為鑽機的持續成長和更深層的市場滲透奠定了基礎。我們預計將實現 2025 年 2.4 億至 2.5 億美元的淨銷售額目標，並且我們有明確的途徑實現年淨銷售收入高峰超過 10 億美元。

Now turning to XPHOZAH. During the first quarter, XPHOZAH grew by 30% compared to last year, not including the one-time gross net adjustments for return, reserve, release. This performance reflects the clear unmet need that exists for patients, the growing role for XPHOZAH's playing in helping patients achieve and maintain target phosphorus levels, and the remarkable momentum our team built in 2024.

現在轉向 XPHOZAH。第一季度，XPHOZAH 與去年同期相比成長了 30%，這還不包括退還、儲備和釋放的一次性淨額調整。這項績效反映了患者明顯未滿足的需求、XPHOZAH 在幫助患者達到和維持目標磷水平方面發揮的日益重要的作用，以及我們團隊在 2024 年建立的顯著勢頭。

It is important to recognize that with the loss of Medicare Part D coverage for phosphate lowering therapies, the dialysis market is undergoing significant disruption, and it is causing increased frustration among both nephrologists and patients. Our decisions around XPHOZAH remain firmly grounded in a commitment to patient care.

重要的是要認識到，隨著聯邦醫療保險 D 部分不再涵蓋降磷療法，透析市場正在經歷重大混亂，這導致腎臟病專家和患者都越來越沮喪。我們圍繞 XPHOZAH 做出的決定仍然堅定地基於對患者護理的承諾。

Amid this uncertainty, we're encouraged by early signals. Patients across both Medicare and non-Medicare segments are successfully accessing the therapy, and real-time feedback from the field reinforces XPHOZAH clinical value.

在這種不確定性中，早期訊號令我們感到鼓舞。醫療保險和非醫療保險領域的患者都成功地獲得了治療，來自現場的即時回饋強化了 XPHOZAH 的臨床價值。

As the environment remains fluid, we are not yet providing formal revenue guidance at this time. Instead, we are closely monitoring uptake and market dynamics, and we will provide further updates as the landscape continues to evolve.

由於環境仍然不穩定，我們目前尚未提供正式的收入指引。相反，我們正在密切監測吸收量和市場動態，並將隨著情況的不斷發展提供進一步的更新。

Across the Board, Ardelyx continues to execute with resolve, discipline, and agility, and we're making progress in our strategic priorities, driving strong commercial execution for IBSRELA, navigating the access complexities and generating important commercial momentum with XPHOZAH, building a pipeline to unlock long-term growth, and continually delivering on a strong financial performance.

總體而言，Ardelyx 繼續以決心、紀律和敏捷性執行，我們在戰略重點方面取得了進展，為 IBSRELA 推動了強大的商業執行，解決了訪問複雜性並通過 XPHOZAH 創造了重要的商業動力，建立了釋放長期增長的渠道，並繼續實現強勁的財務業績。

Our high performing team, differentiated products, and commitment to patient-centric innovation, positioned us to lead and grow in a rapidly evolving healthcare environment, and we remain steadfast as we build long-term value for our shareholders.

我們擁有高效的團隊、差異化的產品以及以患者為中心的創新承諾，這使我們能夠在快速發展的醫療保健環境中引領和發展，並且我們堅定不移地為股東創造長期價值。

Thank you for your continued support and confidence in our Ardelyx, and I will now hand it over to Eric to share his perspectives on our commercial performance during the first quarter. Eric?

感謝大家對我們Ardelyx的持續支持和信任，現在我會把時間交給Eric，分享他對我們第一季商業表現的看法。艾瑞克？

Thanks, Mike, and it's great to be with you all again. Q1 was another great quarter for both products. IBSRELA and XPHOZAH delivered meaningful year-over-year growth. Consistent with prior Q1's, we saw the IBS-C market contract, and as you know, the hyperphosphatemia market was impacted by the elimination of Medicare Part D coverage for phosphate lowering therapies.

謝謝，麥克，很高興再次和你們在一起。對於這兩款產品來說，第一季又是個出色的季度。IBSRELA 和 XPHOZAH 實現了顯著的同比增長。與先前的第一季一致，我們看到 IBS-C 市場萎縮，如您所知，高磷血症市場受到醫療保險 D 部分取消對降磷療法覆蓋的影響。

Despite these headwinds, we saw strong prescription demand for IBSRELA and demonstrated that both Medicare and non-Meddicare patients are able to access XPHOZAH, as we continue to meet the unmet need in the market. The team is focused on execution and building on our Q1 momentum as we enter an important second quarter in a position of strength.

儘管有這些不利因素，我們仍然看到對 IBSRELA 的處方需求強勁，並證明醫療保險和非醫療保險患者都可以獲得 XPHOZAH，因為我們將繼續滿足市場上未滿足的需求。隨著我們以強勁地位進入重要的第二季度，團隊專注於執行並鞏固第一季的勢頭。

Let me start with IBSRELA. IBSRELA grew 57% over last year. This is incredible growth as we enter our third full year of post-approval. We saw increases across key demand indicators, including new and total riders and new and refill prescription.

讓我從 IBSRELA 開始。IBSRELA 比去年增長了 57%。在我們進入批准後的第三個完整年度時，這是令人難以置信的增長。我們看到關鍵需求指標均增加，包括新乘客和總乘客數量以及新處方和續約數量。

As I mentioned before, the IBS-C market historically contracts during the first quarter, and we saw clear evidence of it in Q1, especially early on. Despite that contraction, IBSRELA demonstrated strong prescription demand consistent with Q4 and exited the quarter with very strong momentum. This is further evidence of the confidence that HCPs have in IBSRELA and the value this medicine can bring patients.

正如我之前提到的，IBS-C 市場通常在第一季萎縮，我們在第一季度，尤其是在早期，看到了明顯的證據。儘管出現萎縮，但 IBSRELA 表現出與第四季度一致的強勁處方需求，並以非常強勁的勢頭結束了本季。這進一步證明了 HCP 對 IBSRELA 的信心以及該藥物能為患者帶來的價值。

As we look ahead, we remain focused on making progress against our strategic imperatives to drive growth and help more patients with IBS-C. Which include raising awareness and favorable perception of IBSRELA, expanding target HCP's view of potential IBSRELA patients, positioning IBSRELA as the first action for appropriate patients who are not getting adequate relief or are not satisfied on a secretagogue, and encouraging HCPs to send prescriptions to one of our specialty pharmacy partners or ArdelyxAssist.

展望未來，我們將繼續專注於實現策略目標，推動成長並幫助更多 IBS-C 患者。其中包括提高對 IBSRELA 的認識和良好看法，擴大目標 HCP 對潛在 IBSRELA 患者的看法，將 IBSRELA 定位為未獲得足夠緩解或對促泌劑不滿意的適當患者的首要行動，並鼓勵 HCP 將處方發送給我們的一個專業藥房合作夥伴或 ArdelyxAssist。

These strategic imperatives are allowing us to create opportunities across all aspects of the physician and patient journey to improve HCP perception, drive consideration, and support prescription pull-through. Our expanded skill-based teams and our omni-channel marketing initiatives are focused on these areas, and we continue to see improvement. IBSRELA is an important treatment option for patients with IBS-C, and we remain confident in our path to greater than $1 billion peak-year net sales revenue.

這些策略要務使我們能夠在醫生和患者旅程的各個方面創造機會，以改善 HCP 的看法、推動考慮並支持處方的執行。我們擴大的基於技能的團隊和全通路行銷計劃都集中在這些領域，我們繼續看到進步。IBSRELA 是 IBS-C 患者的重要治療選擇，我們對實現超過 10 億美元的峰值年淨銷售收入充滿信心。

Now on to XPHOZAH. XPHOZAH had another very strong performance, delivering 30% revenue growth compared to last year when you exclude the returns reserve release. This demonstrates that XPHOZAH continues to be an important medicine to help patients achieve and maintain target phosphorus levels, despite the turmoil and disruption in the market.

現在轉到 XPHOZAH。XPHOZAH 再次表現強勁，如果不回報儲備金釋放，其收入與去年相比增長了 30%。這表明，儘管市場動盪不安，XPHOZAH 仍然是幫助患者達到和維持目標磷水平的重要藥物。

It also gives us confidence that XPHOZAH strategy is working. Most importantly, the operational plan has allowed patient access to continue. We're driving a clear message to healthcare providers that is resonating. Prescribe as you always have, based on the patient need, and we will support access through our patient services programs.

這也讓我們相信 XPHOZAH 策略正在發揮作用。最重要的是，該營運計劃允許患者繼續就醫。我們正在向醫療保健提供者傳達一個引起共鳴的明確訊息。根據患者的需求，像往常一樣開處方，我們將透過患者服務計劃支持患者就醫。

As we look at XPHOZAH's performance during the quarter, there were several positive indicators that gives us confidence as we move forward. We saw new riders prescribing during the quarter as well as both new and refill prescriptions continue. In addition, our internal market research indicates that the vast majority of surveyed nephrologists recognize they are the decision makers for XPHOZAH prescriptions, and that they continue to believe that at least 30% of the patients are candidates for XPHOZAH.

當我們回顧 XPHOZAH 在本季的表現時，我們發現了一些正面的指標，讓我們對未來充滿信心。我們看到本季有新的附加處方，並且新處方和續處方也持續進行。此外，我們的內部市場研究表明，絕大多數受訪的腎臟病專家承認他們是 XPHOZAH 處方的決策者，並且他們仍然相信至少 30% 的患者適合使用 XPHOZAH。

To maintain the momentum that the team has established, we must remain focused on the factors that influence our ability to drive demand. There is a high unmet need among dialysis patients for tools to achieve and maintain target phosphorus levels. Physician satisfaction with XPHOZAH remains high. Access to XPHOZAH has been protected.

為了保持團隊已經建立的勢頭，我們必須繼續專注於影響我們推動需求能力的因素。透析患者對達到和維持目標磷水平的工具有著很高的未滿足需求。醫生對 XPHOZAH 的滿意度仍然很高。對 XPHOZAH 的存取已受到保護。

And lastly, we have a strong share voice in the market. The commercial team and all of team Ardelyx have been steadfast in our commitment to bring these first-in-class medicines to patients who continue to struggle with their conditions. We have a winning position in two markets with a high unmet need and a high performing team that consistently drives results, and we are eager to achieve our potential as quickly as we can. We are focused on executing our plan and maintaining the growth momentum for the remainder of the year.

最後，我們在市場上擁有強大的話語權。商業團隊和 Ardelyx 團隊始終堅定不移地致力於為那些仍在與疾病作鬥爭的患者提供一流的藥物。我們在兩個市場中佔據優勢地位，擁有大量未滿足的需求，並且擁有一支高績效團隊，不斷推動成果，我們渴望盡快發揮我們的潛力。我們專注於執行我們的計劃並保持今年剩餘時間的成長勢頭。

I will now turn it over to Justin. Justin?

現在我會把麥克風交給賈斯汀。賈斯汀？

Thank you, Eric. We were very pleased with the financial performance we reported earlier today, which demonstrated significant year-over-year revenue growth, careful management of expenses to support continued commercial excellence, and a strong cast position to continue building the business.

謝謝你，埃里克。我們對今天早些時候報告的財務業績感到非常滿意，這表明收入同比大幅增長，費用管理謹慎以支持持續的商業卓越，並且擁有強大的演員地位以繼續發展業務。

We had total revenues of $74.1 million in the first quarter of 2025, an increase of 61% compared to the $46 million we reported last year. The growth was driven primarily by strong performances and significant increases in net product sales revenue from both of our commercial products in the first quarter of 2025 compared to the same period of 2024.

2025 年第一季度，我們的總收入為 7,410 萬美元，與去年報告的 4,600 萬美元相比增長了 61%。成長主要得益於 2025 年第一季我們兩種商業產品的強勁表現以及與 2024 年同期相比的淨產品銷售收入的大幅成長。

During the first quarter of 2025, we recorded IBSRELA net sales revenue of $44.4 million an increase of 57% over the same period of last year. Our growth was driven by strong patient demand and the continued focus on commercial execution from clinical consideration to prescription pull through. As we've consistently shared with you in the past, our net sales were impacted during the quarter due to normal Q1 market dynamics.

2025 年第一季度，IBSRELA 淨銷售收入為 4,440 萬美元，較去年同期成長 57%。我們的成長受到強勁的患者需求以及從臨床考慮到處方的商業執行的持續關注的推動。正如我們過去一直與您分享的那樣，由於第一季的正常市場動態，我們的淨銷售額在本季度受到了影響。

In line with our expectations, the gross net deduction for IBSRELA for the quarter was 34.8%, and as we've experienced, we expect this to improve throughout the course of the year. We expect continued growth for IBSRELA. We reaffirm our 2025 guidance of $240 million to $250 million in net product sales revenue.

與我們的預期一致，IBSRELA 本季的總淨扣除額為 34.8%，根據我們的經驗，我們預計這種情況將在全年有所改善。我們預計 IBSRELA 將持續成長。我們重申 2025 年淨產品銷售收入目標為 2.4 億至 2.5 億美元。

We also recorded $23.4 million in net product sales revenue of XPHOZAH in the first quarter of 2025, an increase of approximately 55% compared to $15.2 million in the first quarter of last year. As you saw in our press release, XPHOZAH net sales revenue includes a one-time $3.8 million release of our returns reserve. Excluding this returns reserve release, our year-over-year growth for XPHOZAH was 30%.

我們也記錄了 2025 年第一季 XPHOZAH 的淨產品銷售收入 2,340 萬美元，與去年第一季的 1,520 萬美元相比成長了約 55%。正如您在我們的新聞稿中看到的，XPHOZAH 淨銷售收入包括一次性釋放的 380 萬美元退貨儲備金。不計入此次回報儲備釋放，XPHOZAH 的年成長率為 30%。

Our returns reserve considers our returns policy and the passage of time since launch. When coupled with zero product returns to date in our open return window in the very low number of bottles in our downstream distribution channel, it was clear that a returns reserve is unnecessary. As a result, our gross net deduction for XPHOZAH during the first quarter was approximately 18%. Excluding the impact of this release, it was approximately 32%.

我們的退貨儲備考慮了我們的退貨政策以及自推出以來的時間推移。到目前為止，在我們開放的退貨窗口中，下游分銷管道中極少量的瓶子退貨量為零，因此，顯然退貨儲備是不必要的。因此，我們第一季 XPHOZAH 的總淨扣除額約為 18%。除去此次發布的影響，約32%。

In addition to product revenue, we earned a $5 million milestone from our partner in China following the approval of tenapanor for hyperphosphatemia. We received payment from Fosun Pharma in April. We also recorded $1 million in non-cash royalty revenue during the first quarter of 2025 compared to $370,000 in the same period last year.

除了產品收入外，隨著替尼帕諾（tenapanor）獲準用於治療高磷血症，我們還從中國合作夥伴那裡獲得了 500 萬美元的里程碑收入。我們在四月收到了復星醫藥的付款。2025 年第一季度，我們也實現了 100 萬美元的非現金特許權使用費收入，而去年同期為 37 萬美元。

Research and development expenses were $14.9 million for the first quarter of 2025, compared to $10.6 million for the same quarter of the prior year. The increase in R&D expenses reflects increased engagement with the scientific and medical communities.

2025 年第一季研發費用為 1,490 萬美元，而去年同期為 1,060 萬美元。研發費用的增加反映了與科學界和醫學界的合作日益增加。

Selling, general and administrative expenses for the quarter were in line with our expectations at $83.2 million compared to $53 million that were reported for the same period in the prior year. The increase was related to commercial activities for IBSRELA, XPHOZAH, including the IBSRELA salesforce expansion, as well as growth of the overall corporate infrastructure to support our strategy.

本季的銷售、一般及行政開支符合我們的預期，為 8,320 萬美元，去年同期為 5,300 萬美元。這一成長與 IBSRELA、XPHOZAH 的商業活動有關，包括 IBSRELA 銷售隊伍的擴張，以及為支持我們的策略而增加的整體公司基礎設施的成長。

In the first quarter of 2025, we also had $12.1 million in non-cash stock compensation expense and $2.1 million in non-cash interest expense. We had a net loss of approximately $41.1 million or $0.17 per share in the first quarter compared to a net loss of $26.5 million or $0.11 per share in the same period of last year.

2025 年第一季度，我們也出現了 1,210 萬美元的非現金股票薪資支出和 210 萬美元的非現金利息支出。第一季我們的淨虧損約為 4,110 萬美元或每股 0.17 美元，而去年同期的淨虧損為 2,650 萬美元或每股 0.11 美元。

As of March 31, 2025, our total cash, cash equivalents, and short-term investments was $214 million. The first quarter demonstrated strong demand for IBSRELA and clear evidence that the XPHOZAH strategy is working. We remain confident that there is a significant opportunity for both of our medicines that we are on track to achieving our peak sales expectations, more than $1 billion for IBSRELA and $750 million for XPHOZAH. We are building a great company and focused on delivering shareholder value.

截至 2025 年 3 月 31 日，我們的現金、現金等價物及短期投資總額為 2.14 億美元。第一季顯示對 IBSRELA 的強勁需求，有明顯證據表明 XPHOZAH 策略正在發揮作用。我們仍然相信，我們的兩種藥物都有很大的機會實現我們的峰值銷售預期，IBSRELA 的銷售額將超過 10 億美元，XPOZAH 的銷售額將超過 7.5 億美元。我們正在打造一家偉大的公司，並致力於實現股東價值。

With that, I'll hand it back to Mike.

說完這些，我就把話還給麥克。

Thanks, Justin. It's been quite an eventful first quarter, and through all of it, we executed and created opportunities. That will continue to be our focus moving forward.

謝謝，賈斯汀。今年第一季發生了很多事，透過這一切，我們執行並創造了機會。這將繼續是我們未來的重點。

I will now open the call to questions. Operator?

我現在開始提問。操作員？

(Operator Instructions)

（操作員指示）

Louise Chen, Scotiabank.

加拿大豐業銀行的 Louise Chen。

Congratulations on all the progress this quarter. I wanted to ask you two questions here. First, for the IBS-C market, do you expect this to improve as you go through second quarter and beyond versus the contraction that you historically see in the first quarter and how should we see that play out?

恭喜本季取得的所有進展。我想在這裡問你兩個問題。首先，對於 IBS-C 市場，您是否預期隨著第二季及以後的情況會有所改善，而不是像第一季度那樣出現歷史性的萎縮，我們應該如何看待這種情況？

And then secondly, could you explain in more detail the return reserve and how that impacts the sales and what that could look like going forward? Thank you.

其次，您能否更詳細地解釋一下退貨準備金以及它對銷售的影響以及未來可能的情況？謝謝。

Sure, let me ask Justin to start with the second question first.

當然，我先請賈斯汀回答第二個問題。

Thanks, Louise. Yes, so as part of our gross net, we have a returns reserve and our returns reserve, again, as contemplated from the beginning of launch. When you couple our progress over the last five or six quarters where we've had zero returns and very limited [bonds] in our downstream distribution, it was no longer appropriate to carry this reserve on our balance sheet. So we will no longer be doing this prospectively, and this, of course, would have modest improvement to our gross net prospectively.

謝謝，路易絲。是的，作為我們總淨收入的一部分，我們有一個回報儲備，而且我們的回報儲備也是從推出之初就考慮到的。如果將我們過去五、六個季度的進展與零回報以及下游分銷中非常有限的[債券]結合起來，那麼在我們的資產負債表上保留這筆儲備就不再合適了。因此，我們將不再進行前瞻性的此類行動，當然，這將會適度改善我們的未來總淨收入。

Eric?

艾瑞克？

Yeah, thanks, Louise, for the question. With regard to the IBS-C market improving as we go through the year, the short answer to that is yes. The IBS-C market in the first quarter, we know traditionally contracts, and that's exactly what we saw early on in Q1. But we continue to remain very optimistic, given that we had our highest prescription demand quarter in Q1. We were able to -- I'm sorry, in Q4, and we were able to see that consistent in Q1. And certainly, we're able to finish the quarter with strong momentum that gives us a lot of confidence as we move into Q2 in the rest of the year that we'll continue to see that improve.

是的，謝謝路易絲提出這個問題。關於 IBS-C 市場是否會隨著今年的到來而改善，簡短的答案是肯定的。我們知道，第一季的 IBS-C 市場通常會萎縮，而這正是我們在第一季初看到的情況。但考慮到第一季我們的處方需求最高，我們仍然保持非常樂觀的態度。抱歉，在第四季度，我們能夠看到這一點在第一季是一致的。當然，我們能夠以強勁的勢頭結束本季度，這給了我們很大的信心，因為我們將在今年剩餘時間進入第二季度，我們將繼續看到這種情況的改善。

Thank you.

謝謝。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Hi, thanks for the question. Just wanted to ask a little bit more about the 1Q contraction. What are you attributing this sort of the level of overall contraction in 1Q? And looking different from prior 1Q situations? And then, I have a follow up. Thank you.

你好，謝謝你的提問。我只是想多問一些關於第一季收縮的問題。您認為第一季整體經濟出現如此程度的萎縮是為什麼？與之前第一季的情況有何不同？然後，我有一個後續行動。謝謝。

Sure, thanks for the question, Ryan. I think just for some context is, the market has consistently contracted. I think in their first two years on the market, given the volume that we were generating, probably not as much of an impact, but as this business grows, as Eric, I'll ask him to address it, it's something that we are expecting as we move forward. I think if you compare us to others within that market basket, I'm pleased with the performance that we saw out of IBSRELA. Eric?

當然，謝謝你的提問，Ryan。我認為就某些背景而言，市場一直持續萎縮。我認為，在他們進入市場的頭兩年，考慮到我們生產的數量，可能不會產生太大的影響，但隨著業務的增長，正如埃里克所說，我會請他解決這個問題，這是我們在前進過程中所期待的事情。我認為，如果將我們與該市場籃子中的其他公司進行比較，我對 IBSRELA 的表現感到滿意。艾瑞克？

Yeah, I would just add as we continue to grow, volume, we're starting to see a bit of a response similar to that of the market in the first quarter. But it's still a very healthy market continuing to grow double-digit growth as it has over the past few years. And as I mentioned just a minute ago, we expect that to continue to grow in 2025 for the rest of the year.

是的，我想補充一點，隨著銷量的不斷增長，我們開始看到與第一季市場類似的反應。但它仍然是一個非常健康的市場，像過去幾年一樣繼續保持兩位數的成長。正如我剛才提到的，我們預計 2025 年剩餘時間內這一數字將繼續增長。

Got it. And then, what are you targeting for your long-term gross to net if you're disclosing a level for XPHOZAH at steady state? And also, do you have any color or a status update on the launch in in China now that it's approved? Thanks.

知道了。那麼，如果您揭露 XPHOZAH 在穩定狀態下的水平，那麼您對長期毛利與淨利的目標是多少？另外，現在該技術已獲批准在中國推出，您是否有任何消息或狀態更新？謝謝。

Yeah. So the China first, once we get more perspective from our partner, we can share that. So probably not much to talk about there, and Justin, if you could address the gross net?

是的。因此，首先是中國，一旦我們從合作夥伴那裡獲得更多的觀點，我們就可以分享。所以可能沒有什麼好談的，賈斯汀，你能談談總淨值嗎？

Sure. It's still early because we're in the new treatment paradigm, if you will, the coverage mix where is changing in 2025 compared to 2024. So we're not really fully there yet. I would say, we had 32% irrespective of the gross to net change we made for the returns reserve in Q1.

當然。現在還為時過早，因為我們正處於新的治療模式，如果你願意的話，2025 年的覆蓋範圍與 2024 年相比將發生變化。所以我們還沒有完全實現這個目標。我想說的是，無論我們在第一季對回報儲備做出的總額到淨額的變化如何，我們都達到了 32%。

I think it's fair to say, Ryan, and Justin, correct me if I'm wrong, is that generally our guidance for both the 30%, plus or minus 5%, is likely to hold true continually going forward.

我覺得可以公平地說，Ryan 和 Justin，如果我錯了，請糾正我，一般來說，我們對 30% 以及正負 5% 的指導可能會在未來持續有效。

It's a great place to start modeling.

這是開始建模的好地方。

It's very helpful. Thank you very much.

這非常有幫助。非常感謝。

Dennis Ding, Jeffries.

丹尼斯丁，傑弗里斯。

Hi, thanks for taking our questions. Two for me. On IBSRELA, I mean, how do you guys reconcile what's being reported through IMS and the $44 million in revenue that you guys reported? Because based on scripts and I think through some reasonable assumptions, I think people were expecting around $52 million. So the $44 million was quite a surprise to us.

您好，感謝您回答我們的問題。對我來說是兩個。關於 IBSRELA，我的意思是，你們如何協調透過 IMS 報告的內容和你們報告的 4,400 萬美元收入？因為根據劇本並且經過一些合理的假設，我認為人們預計票房收入約為 5200 萬美元。因此，4400萬美元對我們來說是一個相當大的驚喜。

And then, question number two is on the CMS litigation on XPHOZAH. When do you expect the decision on the appeal? And I guess hypothetically, if there were a positive decision and XPHOZAH was given back Part D, how quickly can things be restored back to 2024 levels in terms of the underlying structural logistics at the DOC? Thank you.

然後，第二個問題是關於 CMS 對 XPHOZAH 的訴訟。您預計什麼時候能得到上訴結果？我想，假設做出了積極的決定，XPHOZAH 被歸還了 D 部分，那麼就 DOC 的底層結構物流而言，情況多快能恢復到 2024 年的水平？謝謝。

Well, I'll address the last question first. I mean, it's probably not healthy to get into hypotheticals, just given everything that we're seeing going on in Washington. All of the briefs that need to be filed are filed, and we're just waiting for the courts to set a date. And we will navigate through that and as we learn more, we will certainly bring it to your attention.

好吧，我先回答最後一個問題。我的意思是，考慮到我們在華盛頓看到的一切，進行假設可能並不健康。所有需要提交的簡報都已提交，我們只是在等待法院確定日期。我們將努力解決這個問題，隨著我們了解更多信息，我們一定會提請您注意。

I'll ask Eric to talk a little bit about your question around scripts. But remember, as we talked about this over the years, that there are going to be fluctuations in scripts, which is why what we said consistently is you need to hold us to account for the guidance that we give you. And as you heard all of us say, we are confident that $240 million to $250 million. And the perturbations in the first quarter are part of the reason that we encourage you to look at it as such.

我會讓 Eric 稍微談談你關於劇本的問題。但請記住，正如我們多年來所談論的那樣，劇本會出現波動，這就是為什麼我們一直說你需要讓我們對我們給你的指導負責。正如大家所說，我們有信心達到 2.4 億至 2.5 億美元。第一季的擾動是我們鼓勵您這樣看待它的原因之一。

Eric, any thought?

艾瑞克，有什麼想法嗎？

Yeah, thanks, Dennis. Good question. As we think about demand, we were very pleased with what we saw in Q1. As I noted, consistent with what we saw in Q4, which was our highest demand quarter to date. Certainly, when you look at net sales, it can be impacted by market dynamics.

是的，謝謝，丹尼斯。好問題。當我們考慮需求時，我們對第一季看到的情況感到非常滿意。正如我所指出的，這與我們在第四季度看到的情況一致，這是我們迄今為止需求最高的一個季度。當然，當你查看淨銷售額時，它可能會受到市場動態的影響。

When we think about Q1, we typically see things like the IBS-C market contract. We've got prior authorization renewals, insurance coverage resets, wholesaler buying patterns, and higher patient co-pays, and all that needs to be taken into consideration. But what gives us confidence is we've seen that in the past. We also see that it normalizes, and we feel like we really ended the quarter with strong momentum and certainly feel very confident as we go into Q2.

當我們考慮第一季時，我們通常會看到像 IBS-C 市場合約這樣的東西。我們有事先授權續約、保險範圍重置、批發商購買模式和更高的患者共同支付，所有這些都需要考慮。但讓我們有信心的是，我們過去已經看到過這種情況。我們也看到它正在正常化，我們覺得我們確實以強勁的勢頭結束了本季度，並且對進入第二季度充滿信心。

And Dennis, I think what's important about that strong momentum, Q1 was our second highest generation of demand to date, right? So what Eric just described certainly is I'm sure from the perspective that you're bringing frustrating, given the numbers that you thought. But we're extremely happy with the performance that we saw, particularly since this is the second highest demand. And we were not impacted by the contraction the way other products were in the IBS-C market basket.

丹尼斯，我認為這種強勁勢頭的重要意義在於，第一季是我們迄今為止需求量第二高的時候，對嗎？因此，我確信從你的角度來看，埃里克剛才所描述的情況肯定會令人沮喪，因為你想到了這些數字。但我們對所看到的表現感到非常滿意，特別是因為這是第二高的需求。而且我們並沒有像 IBS-C 市場籃子中的其他產品那樣受到收縮的影響。

Got it, thanks.

明白了，謝謝。

Laura Chico, Wedbush Securities.

勞拉‧奇科（Laura Chico），韋德布希證券公司。

Thank you very much for taking our question. This is Dylan on for Laura Chico. I was just wondering what metrics are you monitoring to assess the impact of the newly expanded IBSRELA of field force? And what gives you confidence that you're on a trajectory to meet the peak peak revenue expectations?

非常感謝您回答我們的問題。這是 Dylan 為 Laura Chico 表演的。我只是想知道您正在監控哪些指標來評估新擴展的 IBSRELA 對現場力量的影響？那麼，什麼讓您有信心您能夠達到高峰收入預期呢？

Sure. First of all, is I think the caliber of the people that we've hired and what we're seeing already coming out of the first -- the fourth quarter, excuse me, fully on board and trained, gives us that confidence. As I just said, Dylan, that this was the second largest quarter of demand generation that we've seen since launch. That is part of the confidence I get in it.

當然。首先，我認為我們所聘用人員的素質以及我們在第一季（對不起，在第四季度）已經看到的表現，完全加入並接受過培訓，這給了我們信心。正如我剛才所說，迪倫，這是我們自推出以來看到的第二大需求成長季度。這是我對此產生的信心的一部分。

In the midst of that market contraction, as I said, we contracted less than the others. That gives me confidence. The incredible unmet need that's out there and the better access that we have with the larger sales organization, I think all comes together.

正如我所說，在市場萎縮期間，我們的萎縮幅度比其他公司小。這給了我信心。我認為，市場上存在的大量未滿足需求，以及我們與大型銷售組織之間的更好聯繫，所有這些都結合在一起了。

Eric, other thoughts?

艾瑞克，還有其他想法嗎？

Yeah. For me, I mean, what I think about it is really three things. Are we seeing an increase in activity? Are we seeing an increase in writers, whether it be total riders or new writers? And then, are we seeing that lead to new and refill prescriptions? And as it relates to year over year, we certainly see significant increase in activity, we see an increase in new and total riders, and then we also see an increase in the new and the refill prescriptions.

是的。對我來說，我對此的想法實際上有三件事。我們是否看到活動增加？我們是否看到作家數量增加，無論是總騎手還是新作家？那麼，我們是否看到這會導致新的處方和補充處方？與去年同期相比，我們確實看到活動量顯著增加，我們看到新乘客數量和總乘客數量有所增加，然後我們也看到新處方和續約數量有所增加。

As Mike mentioned, Q1 is the second highest demand -- prescription demand quarter to date. And there we saw an increase in total riders as well as new and refill prescriptions looked really good coming off of what Mike said was, our highest demand quarter in Q4.

正如麥克所提到的，第一季是迄今為止處方需求第二高的季度。我們看到，乘客總數以及新處方和續處方的數量都有所增加，這看起來非常好，正如麥克所說，這是我們第四季需求最高的一個季度。

So those are some of the basic metrics that we look at to make sure that we're getting the activity that we need. It's generating new and total riders that's leading to new and refill prescriptions, so that we can help the higher number of patients out there that need this treatment for their IBS-C.

這些是我們關注的一些基本指標，以確保我們獲得所需的活動。它正在產生新的和總的附加條款，從而帶來新的和補充的處方，這樣我們就可以幫助更多需要這種治療 IBS-C 的患者。

Thank you.

謝謝。

Joseph Thome, TD Cowen.

約瑟夫·托米（Joseph Thome），考恩（Cowen）TD。

Hi, there, good afternoon. Thank you for taking our questions. Maybe the first one, can you comment a little bit on the demand specifically in the commercial channel, and how that changed from Q4 to Q1 for XPHOZAH, just to kind of get an idea of growth in that segment.

大家好，下午好。感謝您回答我們的問題。也許是第一季度，您能否具體評論一下商業管道的需求，以及 XPHOZAH 從第四季度到第一季的需求變化，以便了解該領域的成長情況。

And then a question on the financials, when we look at the R&D and SG&A spend for this quarter, should we use this as sort of a new base going forward? And maybe relatedly, how much wiggle room do you have in the spend for exposure to make sure, that business stays profitable going forward depending on what we see this year? Thank you.

然後是關於財務的一個問題，當我們查看本季的研發和銷售、一般及行政費用支出時，我們是否應該將其用作未來的新基礎？也許與此相關的是，根據我們今年的觀察，您在曝光支出方面有多少迴旋餘地，以確保業務在未來保持盈利？謝謝。

Sure. Let me ask Justin to address the second part of your question first.

當然。我先請賈斯汀回答你問題的第二部分。

Great. So thanks, Joe. Yes, we have a modest increase in our SG&A in Q1 compared to Q4, so you might have seen an increase from $76 million to $83 million. And we expect to -- that will rise over the course of 2025 to around $90 million by the end of the year, making sure we have all the appropriate team members to support the commercial team, and to your point, make sure XPHOZAH and all the patient access and everything else is available through our either our patient assistance program, our field managers and everything between.

偉大的。謝謝喬。是的，我們第一季的銷售、行政及管理費用（SG&A）與第四季度相比略有增加，所以你可能已經看到從7600萬美元增加到了8300萬美元。我們預計，到 2025 年，這一數字將上升到年底的 9000 萬美元左右，確保我們擁有所有合適的團隊成員來支持商業團隊，並且正如您所說，確保 XPHOZAH 和所有患者訪問以及其他一切都可以通過我們的患者援助計劃、我們的現場經理以及介於兩者之間的一切獲得。

So we feel like that is in good shape and some modest increase over the next few quarters. From an R&D perspective, we were approximately $15 million in the first quarter and we expect modest growth in that over the course of the year. So we're in great shape again. We finished the quarter with $214 million, and we're in good shape for financial position.

因此，我們認為情況良好，未來幾季將略有成長。從研發角度來看，第一季我們的研發支出約為 1,500 萬美元，我們預計全年研發支出將適度成長。所以我們又恢復了良好的狀態。本季我們的利潤為 2.14 億美元，財務狀況良好。

And Joe, just to clarify, your question is more than just commercial, it's the non-Meddicare segment, right?

喬，我只是想澄清一下，你的問題不僅僅是商業問題，還涉及非醫療保險領域，對嗎？

Correct, yeah.

正確，是的。

Okay. Yeah, Eric, if you could address that?

好的。是的，艾瑞克，你能解決這個問題嗎？

Yeah. Thanks, Joe. What we saw in Q1 was we saw that Medicare had about a weighted average of around 13% of the total payer mix. We think about that, we saw that it was primarily in the first few weeks. Unfortunately, these patients had the benefit of a one-time transitional fill through CMS, and we saw that take place.

是的。謝謝，喬。我們在第一季看到，Medicare 的加權平均佔總支付方比例的 13% 左右。我們考慮了一下，發現這主要發生在最初的幾週。不幸的是，這些患者可以透過 CMS 獲得一次性過渡填充的好處，而且我們看到了這種情況的發生。

And like I said, it was primarily in the first few weeks. But what we saw as the quarter continued to move was the rest of the mix was really predominantly through the commercial and the Medicaid side, which, as you know, as is the non-Medicare mix.

正如我所說的，這主要發生在最初的幾週。但隨著本季度的持續變化，我們看到其餘組合實際上主要透過商業和醫療補助方面，正如你所知，非醫療保險組合也是如此。

So we were able to see a good momentum there as the quarter continued and feel really good about where things ended at the end of Q1, and that's given us continued confidence as we move forward. And really focusing on being able to allow all patients, regardless of whether it's Medicare or non-Meddicare, be able to have access moving forward.

因此，隨著本季度的繼續，我們能夠看到良好的勢頭，並且對第一季末的情況感到非常滿意，這給了我們繼續前進的信心。真正專注於讓所有患者，無論是醫療保險或非醫療保險，都能獲得治療。

Yeah. I guess I just want to follow up to the financial question is it's not that we're necessarily looking for wiggle room. I think we have incredible confidence on the trajectory that we're on with XPHOZAH in the way that we've approached the market. So it's not that we're looking for wiggle room, I think we're on track with what we anticipate, which is why we reaffirm the $750 million peak. And the hope is an expectation that in the not too distant future, we can give you more perspectives of what our views are for this year.

是的。我想我只是想跟進財務問題，我們不一定在尋找迴旋餘地。我認為，我們對 XPHOZAH 的發展軌跡以及我們進入市場的方式充滿信心。因此，我們並不是在尋找迴旋餘地，我認為我們已經達到了預期目標，這就是我們重申 7.5 億美元高峰的原因。我們希望在不久的將來能夠為您提供更多關於我們對今年的看法的觀點。

Great. Thank you very much, very helpful.

偉大的。非常感謝，非常有幫助。

Thanks, Joe.

謝謝，喬。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

Hey, afternoon, everyone. Follow up about XPHOZAH. I'm just curious, do you have any updates on the how the patient assistance program is operating right now and some of your plans to keep going forward into 2Q and 3Q?

大家下午好。追蹤 XPHOZAH。我只是好奇，您是否有任何關於患者援助計劃目前運作情況的最新消息，以及您在第二季度和第三季度繼續推進的一些計劃？

And the second part of it is I was also curious off the last question, thinking about commercial and non-Medicare, how are those trends, possibly tracking into exiting 1Q and thinking about 2Q and 3Q?

第二部分是，我對最後一個問題也很好奇，考慮商業和非醫療保險，這些趨勢如何，可能追蹤到第一季並考慮第二季和第三季？

Sure. Let me ask Eric to address those for you.

當然。讓我請艾瑞克為您解答這些問題。

Yeah. So thank you. So with regards to PAP or the patient assistance program, we're very pleased with how the ArdelyxAssist is being able to help patients in need, particularly those Medicare patients. We saw patients that were on XPHOZAH for Medicare Part D and Q4, they were able to continue accessing XPHOZAH in Q1 through our patient assistance program. So I would say, we were very pleased with being able to help those patients out and certainly new patients as they come on in first quarter.

是的。所以謝謝你。因此，關於 PAP 或患者援助計劃，我們對 ArdelyxAssist 能夠幫助有需要的患者，特別是那些醫療保險患者感到非常高興。我們看到，正在接受 Medicare D 部分和 Q4 的 XPHOZAH 治療的患者，他們能夠透過我們的患者援助計劃在 Q1 繼續接受 XPHOZAH 治療。所以我想說，我們非常高興能夠幫助這些患者，當然還有第一季到來的新患者。

We are in this for the long term. For us, it's paramount that we are able to provide access for those patients in need. And so we're not looking at it on a quarterly basis. It's not a Q2, Q3, Q4 decision for us. We're continuing to move forward so that all patients, regardless of Medicare and non-Meddicare have coverage for XPHOZAH.

我們將長期致力於此。對我們來說，最重要的是我們能夠為有需要的患者提供治療。因此我們不會按季度來看待這個問題。對我們來說，這不是第二季、第三季、第四季的決定。我們將繼續努力，以便所有患者，無論是否參加醫療保險，都能享有 XPHOZAH 的保障。

With regards to the commercial business, again, very pleased with what we're seeing there on the non-Medicare segments. As I noted, we saw really the vast majority of the Medicare transitional fields within the first few weeks, but really that dissipated.

關於商業業務，我們對非醫療保險領域的表現感到非常滿意。正如我所指出的，我們在最初幾週內確實看到了絕大多數醫療保險過渡領域，但實際上這些領域已經消失了。

And we really aren't factoring that into our models as we look at things and forecast moving forward. It's really focused on driving that non-Meddicare business primarily through commercial, Medicaid, and the VA business that we saw really increase in that latter half of Q1, and that's what's given us confidence as we move into the remainder of the year.

當我們觀察事物並預測未來發展時，我們並沒有將這一點納入我們的模型中。它真正專注於推動非醫療保險業務，主要透過商業、醫療補助和 VA 業務，我們看到這些業務在第一季後半段確實有所成長，這給了我們對今年剩餘時間的信心。

I mean, just a couple of comments on that, Roanna, is if you -- the confidence that we have coming from January where, everything, everyone was wondering how this was going to work. And then as it progressed through to March, the strategy is working. I think no one can underestimate the impact on these patients of the turmoil that they're facing and suddenly having to get their binders through the DOs.

羅安娜，我想對這個問題發表幾點看法，那就是——我們的信心來自於一月份，當時每個人都在想這將如何進行。而隨著三月的進展，這項策略開始發揮作用。我認為沒有人可以低估這些患者所面臨的混亂以及突然必須透過 DO 獲得黏合劑對他們的影響。

Some of the binders that they've been on for a long time aren't available, and ultimately, us having to work and choosing to work with the nephrologist at the center of the decision making as they were before in the midst of all this turmoil. I'm very pleased the way that the team has actually helped them navigate through it and the strength of the ArdelyxAssist team in the program there in particular is paying dividends.

他們長期使用的某些黏合劑現在無法使用了，最終，我們不得不與腎臟病專家合作，選擇他們作為決策的中心，就像之前在這場混亂中所做的那樣。我很高興看到團隊確實幫助他們解決了這個問題，尤其是 ArdelyxAssist 團隊在這個專案中所展現出的優勢。

Got it. Thanks for the help.

知道了。謝謝你的幫忙。

Thank you.

謝謝。

Julian Harrison, BTIG.

朱利安·哈里森（Julian Harrison），BTIG。

Hi, thank you for taking my questions. When you look at high volume IBS-C prescribers, are you left with the impression that they generally know who the best candidates are for IBSRELA? And I asked this because I am aware of some recent survey data you guys have suggesting a disconnect between prescribers and patients on how large the unmet need is. And I'm also just wondering how you expect maybe the gap to narrow there going forward?

你好，謝謝你回答我的問題。當您查看大量 IBS-C 處方時，您是否留下這樣的印象：他們通常知道誰是 IBSRELA 的最佳候選人？我之所以問這個問題，是因為我知道你們最近的一些調查數據表明，醫生和患者對於未滿足需求的大小存在分歧。我還想知道您認為未來差距會如何縮小？

Yeah. I mean, just one quick comment. I'll ask Eric to address it. A disconnect between prescriber and patients is probably a pretty traditional phenomenon across many therapeutic areas. And to me, at least with what I see, the significant untapped potential that's out there is remarkable. Don't forget that all of our clinical work was first line therapy. And the fact that a new mechanism like this given payer dynamics is what forces you into making the decision we did, because we didn't want to negotiate with payers that we would be second line is what gets us to where we are.

是的。我的意思是，我只想說一句。我會讓 Eric 來解決這個問題。處方醫生和患者之間的脫節可能是許多治療領域中相當傳統的現象。對我來說，至少就我所見，那裡還存在著巨大的未開發潛力。不要忘記，我們所有的臨床工作都是第一線治療。事實上，考慮到付款人的動態，這種新機制迫使我們做出我們所做的決定，因為我們不想與付款人談判，讓我們成為第二線，這就是我們走到今天這一步的原因。

The dissatisfaction when you talk to patients with what they have with GCC agonist is kind of hard when a physician doesn't yet understand this new mechanism and what it is that we can provide that they may see a disconnect between the patients thing. But that's the work and why we expanded the field and the yields that we're seeing from that effort. Eric?

當醫生還不了解這種新機制以及我們能提供什麼時，當你與患者談論他們對 GCC 激動劑的感受時，他們會感到不滿意，這很困難，因為他們可能會發現患者的情況與醫生的描述存在脫節。但這就是工作，也是我們擴大領域和從努力中看到的利益的原因。艾瑞克？

Yeah. I would just add there, there's certainly is plenty of opportunity out there. You mentioned the disconnect and we're very much aware of that and really take it very seriously and our responsibility to help connect the physician and the patient. I think, patients -- physicians, they do recognize who these patients are. It's actually -- when we talk to physicians, it's patients that are diagnosed with IBS-C. They're currently on a secretagogue therapy, and yet they're not satisfied or they're not getting that relief.

是的。我只想補充一點，那裡肯定有很多機會。您提到了脫節，我們非常清楚這一點，並且非常重視這個問題，並有責任幫助醫生和患者建立聯繫。我認為，病人－醫生，他們確實知道這些病人是誰。事實上——當我們與醫生交談時，患者被診斷出患有 IBS-C。他們目前正在接受促分泌療法，但並不滿意或沒有得到緩解。

For us, it's really trying to get the physician to act with urgency. They've been writing secretagogue now for a decade. And so we need to continue to try to break these habits. It's getting them to recognize the appropriate patient. I think we feel like we're getting traction there. But then it's really acting with urgency, so that they can be the first choice once that patient really is not satisfied or they're not getting adequate relief.

對我們來說，這實際上是試圖讓醫生緊急採取行動。他們寫 secretagogue 已經有十年了。因此我們需要繼續努力改掉這些習慣。它讓他們識別出合適的病人。我想我們感覺我們正在獲得進展。但它確實採取了緊急行動，以便當患者真的不滿意或沒有得到足夠的緩解時，他們可以成為首選。

And we know that's quite a few patients because we know about a third of those patients out there are satisfied. So that leaves quite a few patients out there that are currently diagnosed on a treatment, not satisfied and getting adequate relief, that we're seeing IBSRELA being used really second line for those patients.

我們知道有相當多的患者，因為我們知道其中大約三分之一的患者感到滿意。因此，有相當多的患者目前被診斷接受某種治療，但對治療結果並不滿意，也沒有得到足夠的緩解，因此我們看到 IBSRELA 真正被用作這些患者的二線治療。

Aydin Huseynov, Ladenburg.

拉登堡的艾登‧胡賽諾夫 (Aydin Huseynov)。

Hi, good afternoon, everyone. Congratulations with this quarter. I got a couple of questions. So appreciate XPHOZAH's long-term guidance confirmation $750 million. So could you provide some dynamic of sort of how you plan to get there, sort of ramp up curve? And If possible, any 2025 sort of soft guidance kind of hints? And does the long-term guidance not include Medicare? And in case you'll be able to sort of include Medicare, further on would -- how would that actually affect the upside of XPHOZAH sales, peak sales?

大家好，下午好。恭喜本季。我有幾個問題。因此感謝 XPHOZAH 的 7.5 億美元長期指導確認。那麼，您能否提供一些關於您計劃如何實現這一目標的動態信息，例如上升曲線？如果可能的話，有任何 2025 年類型的軟指導提示嗎？長期指導不包括醫療保險嗎？如果您能夠將醫療保險納入其中，那麼這實際上會對 XPHOZAH 的銷售、高峰銷售產生什麼影響？

Sure. Let me address that for you is, we assume Medicare is not part of the mix in terms of paying for XPHOZAH for those patients. That's roughly 60% of the dialysis population is Medicare. Non-Meddicare is primarily Medicaid and commercial. And the comments from both both Eric and I that what we see already in the first quarter makes us feel confident that, that is going to be what we are able to confidently get to $750 million.

當然。讓我來為您解釋一下，我們假設醫療保險不屬於為這些患者支付 XPHOZAH 費用的範疇。這意味著大約 60% 的透析人口都享有醫療保險。非醫療保險主要是醫療補助和商業醫療保險。艾瑞克和我都表示，我們在第一季看到的情況讓我們充滿信心，我們有信心達到 7.5 億美元。

As we said last year, as we were entering this year and reaffirmed in my opening comments, it's too early for us to be giving you guidance as to what 2025 is going to look like. We are -- once we have confidence, and I believe it will happen in the not-too-distant future, we will provide you some perspective as to what we think 2025 will turn out to be.

正如我們去年所說的那樣，當我們進入今年時，並在開場白中重申，現在就為大家提供 2025 年將會是什麼樣子的指導還為時過早。一旦我們有了信心，我相信這將在不久的將來發生，我們將為您提供一些關於我們認為 2025 年將會是什麼樣子的觀點。

Thank you. I appreciate that. And one follow-on question. How much of the decision making by nephrologists may affect the insurance coverage? And have you seen any pushback from payers so far for XPHOZAH, given your sort of ongoing negotiations with CMS?

謝謝。我很感激。還有一個後續問題。腎病專家的決策有多大程度上會影響保險範圍？鑑於您與 CMS 正在進行的談判，到目前為止，您是否看到付款人對 XPHOZAH 有任何反對意見？

Sure. Well, [payer and CMS] probably not correlated, two very separate things. The nephrologist and the HCPs are extremely important as it relates to getting prior authorizations through. Eric, other thoughts?

當然。嗯，[付款人和 CMS] 可能不相關，是兩件截然不同的事情。腎臟病專家和 HCP 非常重要，因為這關係到獲得事先授權。艾瑞克，還有其他想法嗎？

Yeah. I would just say, right now, we're really not seeing any pushback on the commercial side. And it's good to see that the nephrologist still has the ownership and really is at the center of the decision making. And for those patients that need it, if they have commercial coverage, then certainly, the physician can write for it, and we've got confidence that the patient can get it on the commercial side.

是的。我只想說，目前我們確實沒有看到商業上的任何阻力。很高興看到腎臟病專家仍然擁有所有權並且真正處於決策的中心。對於那些需要它的患者，如果他們有商業保險，那麼當然，醫生可以為它寫，我們有信心患者可以在商業方面獲得它。

And our ArdelyxAssist program is extremely helpful in navigating that process.

我們的 ArdelyxAssist 課程對於指導此過程非常有幫助。

All right. Thank you. Thanks so much.

好的。謝謝。非常感謝。

Thank you.

謝謝。

Allison Bratzel, Piper Sandler.

艾莉森‧布拉澤爾，派珀‧桑德勒。

Hi, thanks for taking the question. This is Ashley on for Allie Bratzel. I have two questions. First one being related to XPHOZAH. It seems like we haven't really heard much about the Kidney PATIENT Act. It seems like this is kind of shaping up to be what you would call a call option. Do you have any updated color on that front, anything you've heard?

你好，謝謝你回答這個問題。這是艾莉·布拉澤爾的艾希莉。我有兩個問題。第一個與 XPHOZAH 有關。似乎我們並沒有真正聽說過太多有關腎病患者法案的事情。這看起來有點像你所謂的看漲期權。您對此有什麼更新的顏色嗎？您聽過什麼嗎？

And then my second question is related to potentially bringing in a GI or renal adjacent external asset. You guys previously signaled some interest in doing that. Is that still the plan? Do you have any color on when we might hear about this? Are you kind of focused more on the ongoing launches with your commercial products? Anything on that phone would be really helpful. Thank you.

我的第二個問題與引入胃腸道或腎臟鄰近外部資產的可能性有關。你們之前曾表示過對此有興趣。這還是計劃嗎？您能告訴我們什麼時候可以聽到這個消息嗎？您是否更關注商業產品的持續推出？手機上的任何東西都會非常有用。謝謝。

Sure, thanks for the questions. In terms of bringing in assets as we've described, we've recently built out a team with Mike Kelliher to look at corporate development, in-licensing, acquisition of assets, certainly in direct -- in our spaces in renal and GI and adjacent spaces as appropriate.

當然，謝謝你的提問。正如我們所描述的，在引入資產方面，我們最近與 Mike Kelliher 組建了一個團隊，負責研究企業發展、許可、資產收購，當然是直接收購——在腎臟和胃腸道領域以及鄰近領域酌情進行。

And that work continues. We're excited about progress is being made. When there's something to talk about both in terms of internal development of some of the approaches we could have with programs that we have developed, we will announce that as anything that we bring in from the outside. So it's an incredibly important part of our efforts to build this enterprise as we believe we can.

這項工作仍在繼續。我們對正在取得的進展感到非常興奮。當我們在內部開發方面需要討論一些有關我們已開發程序的方法時，我們會宣布我們從外部引入任何內容。因此，這是我們努力建立這個企業的一個極其重要的一部分，我們相信我們能夠做到這一點。

As it relates to the Kidney PATIENT Act, you hit the nail on the head. Think of it as a free call option. What we -- at the end of last year, we communicated is that you should hold our feet to the fire around the $750 million and that comes from 40% of the dialysis patients, which is roughly [$220,000] would be our our TAM. So free call option is exactly what you think about it.

就其與《腎臟病患者法案》的關係而言，您說得一針見血。將其視為免費通話選項。我們在去年年底傳達的訊息是，您應該向我們施加壓力，要求我們支付 7.5 億美元的費用，這筆費用來自 40% 的透析患者，大約是 [220,000 美元]，這將是我們的 TAM。因此，免費看漲期權正是您所想的那樣。

Great. Thank you so.

偉大的。非常感謝。

Thank you.

謝謝。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Hi, this is (inaudible) on for Prakhar. Trying to get a better sense of the strategy around expanding XPHOZAH uptake in non-Medicare channels. And when we expect to see the stronger uptake materialized within these non-Medicare channels?

大家好，這是 Prakhar 的（聽不清楚）。試圖更了解擴大非醫療保險管道中 XPHOZAH 吸收的策略。我們何時才能預期這些非醫療保險管道內會出現更強勁的成長動能？

I'm sorry, I couldn't hear the the entire question. Expanding XPHOZAH to Medicare, did you say?

抱歉，我沒聽清楚整個問題。您說的是將 XPHOZAH 擴展到醫療保險嗎？

Non-Medicare channels. What is the strategy around expanding XPHOZAH of taking non-Medicare channels?

非醫療保險管道。XPHOZAH 擴大非醫療保險管道的策略是什麼？

Yeah. So with non-Medicare, that's going to be Medicaid, as I said, and commercial are the two main components of non-Medicare, and that is 40% of the patient population. They are seen by nephrologists, which are the people that we call on. And one of the important aspects of the way that we do it is we don't tell the nephrologist to discern who's Medicare and non-Medicare.

是的。因此，對於非醫療保險，正如我所說，那就是醫療補助和商業是非醫療保險的兩個主要組成部分，佔患者總數的 40%。他們由腎臟科醫師看診，也就是我們請來的人。我們這樣做的一個重要方面是，我們不會告訴腎臟病專家要辨別誰有醫療保險，誰沒有醫療保險。

We have a closed distribution system that goes through ArdelyxAssist program, so that we adjudicate those who are Medicare and those who aren't Medicare. And those who are Medicare, transition into our patient assistance program. And if they qualify, they get free drug. If they aren't Medicare, then we work with them through the system if there's prior office or not to get their prescriptions filled.

我們有一個透過 ArdelyxAssist 計劃的封閉分發系統，以便我們裁決哪些人享有醫療保險，哪些人不享有醫療保險。那些享有醫療保險的人將轉入我們的患者援助計劃。如果他們符合條件，他們就可以獲得免費藥物。如果他們沒有醫療保險，那麼我們會透過系統與他們合作，無論是否有預先辦公室來配藥。

That concludes our question-and-answer session. Now I'll turn the call over to our host for any additional or closing remarks.

我們的問答環節到此結束。現在我將把電話轉給主持人，請他發表任何補充或結束語。

Thank you all for joining us this afternoon, and a special shout out goes to team Ardelyx, who I know is listening. Your hard work is invaluable in bringing our essential medicine to our patients. Thanks also to our shareholders. We are building a great company and focused on doing what is right for patients and creating long-term value. With that, we can conclude the call.

感謝大家今天下午加入我們，特別感謝 Ardelyx 團隊，我知道他們正在傾聽。您的辛勤工作對於我們為患者提供必需的藥物具有無價的價值。也感謝我們的股東。我們正在打造一家偉大的公司，專注於為患者做正確的事情並創造長期價值。這樣，我們就可以結束通話了。

Thank you, operator.

謝謝您，接線生。

That concludes today's meeting. Thank you for joining and have a pleasant day.

今天的會議到此結束。感謝您的加入並祝您有個愉快的一天。