Ardelyx Inc (ARDX) 2024 Q4 法說會逐字稿

Welcome to the Ardelyx fourth quarter and fiscal year 2024 earnings call. (Operator Instructions)

歡迎參加 Ardelyx 第四季和 2024 財年財報電話會議。（操作員指令）

I would now 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 morning and welcome to our fourth quarter in full year 2024 financial results call. During this call, we will refer to the press release issued early earlier today, which is available on the investor section of the company's website at ardelyx.com.

謝謝。早上好，歡迎參加我們 2024 年全年第四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 的投資者專區查閱。

During this call, we will 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 annual report on Form 10-K 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，我們將做出受風險和不確定性影響的前瞻性陳述。我們的實際結果可能與所描述的結果有很大差異。我們鼓勵您查看我們今天提交的最新 10-K 表年度報告中的風險因素，您可以在我們的網站 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，但我們明確表示不承擔任何義務，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 fourth quarter of 2024. Next, Eric Foster, Chief Commercial Officer, 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 fourth quarter and full year ended December 31, 2024, 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在 2024 年第四季度的進展。接下來，首席商務長 Eric Foster 將介紹 IBSRELA 和 XPHOZAH 的業績更新。在我們開始提問之前，財務和營運長賈斯汀·倫茨 (Justin Renz) 將以對公司第四季度和截至 2024 年 12 月 31 日的全年財務業績的回顧來結束今天的準備好的發言。

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

說完這些，讓我把電話轉給麥克。

Thank you, Caitlin, and good morning, everyone. I'm pleased to be here today to discuss our fourth quarter and full year 2024 performance.

謝謝你，凱特琳，大家早安。我很高興今天能在這裡討論我們的第四季和 2024 年全年業績。

In the past year, our team's dedication to outstanding commercial execution led to numerous significant achievements. Its relative growth continued throughout 2024 with an acceleration in the fourth quarter as we began to see the positive impact of our expanded sales team.

在過去的一年裡，我們團隊致力於出色的商業執行，並取得了許多重大成就。隨著我們開始看到擴大銷售團隊帶來的正面影響，其相對成長持續貫穿整個 2024 年，並在第四季加速。

It is evident that patients are benefiting from IBSRELA, as this important medication provides rapid and lasting relief from the symptoms of IBS-C-, which can significantly disrupt patients' lives. For XPHOZAH, our team successfully executed one of the best product launches in recent years.

顯然，患者正在受益於 IBSRELA，因為這種重要的藥物可以快速且持久地緩解 IBS-C 的症狀，而這種症狀可能會嚴重擾亂患者的生活。對於XPOZAH，我們的團隊成功執行了近年來最好的產品發布之一。

In the first year of sales, we demonstrated that XPHOZAH is a crucial medication for dialysis patients, enabling them to achieve and maintain target phosphorus levels. In the midst of this outstanding performance, we confidently tackle the challenging reimbursement environment.

在銷售的第一年，我們證明了 XPHOZAH 是透析患者的關鍵藥物，使他們能夠達到並維持目標磷水平。在取得優異成績的同時，我們有信心應付充滿挑戰的報銷環境。

Our commitment to prioritizing patient needs has never wavered. We've taken strong, decisive actions, and we're dedicated to ensuring that patients continue to have access to XPHOZAH as they always have, regardless of the coverage changes made by CMS. Our commitment to protecting patient access guarantees that at a minimum, we will continue to serve dialysis patients as we aim to grow the exposed business to at least $750 million before patent expiring.

我們優先考慮患者需求的承諾從未動搖。我們採取了強有力的果斷行動，並致力於確保患者能夠繼續像往常一樣獲得 XPHOZAH，無論 CMS 對覆蓋範圍做出何種更改。我們致力於保護患者的治療機會，這至少保證了我們將繼續為透析患者提供服務，我們的目標是在專利到期前將業務規模擴大到至少 7.5 億美元。

Building on the impressive performance of both IBSRELA and XPHOZAH, we successfully reinforced our cash reserves, finishing 2024 with a strong cash position, paving the way for future growth. These accomplishments established the foundation for our growth in '25 and beyond, and we're poised to execute our strategic priorities with determination, firmly anchored in our commitment to commercial excellence.

基於 IBSRELA 和 XPHOZAH 的出色表現，我們成功加強了現金儲備，並在 2024 年底擁有強勁的現金狀況，為未來成長鋪平了道路。這些成就為我們在25年及以後的發展奠定了基礎，我們準備堅定地執行我們的策略重點，堅定地致力於商業卓越。

IBSRELA's growth momentum is continuing as the commercial team builds clinical conviction among prescribers, which alongside our exceptional patient services team, ensures that prescriptions are filled and reach patients. IBSRELA is an outstanding product, and patients deserve access to this treatment and the benefit it provides.

隨著商業團隊在處方人員中建立臨床信念，IBSRELA 的成長勢頭持續下去，這與我們卓越的患者服務團隊一起確保處方得到配製並送達患者。IBSRELA 是一款出色的產品，患者應該接受這種治療並享受其帶來的好處。

Despite the coverage changes, the CKT community is navigating, preliminary evidence clearly indicates that our exposure strategy is effective and that patients across all access paths are successfully receiving treatment. We're extremely proud of our team's performance and the strong initial indicators we're observing, which Eric will share with you momentarily.

儘管覆蓋範圍發生了變化，CKT 社區仍在探索，初步證據清楚地表明我們的暴露策略是有效的，並且所有訪問路徑的患者都成功地接受了治療。我們對團隊的表現以及我們觀察到的強勁初步指標感到非常自豪，Eric 稍後會與大家分享。

Our exceptional commercial execution has demonstrated our ability to establish a sustainable and resilient company. Our corporate development team is focused on building a robust pipeline and are actively identifying and evaluating a range of internal and external opportunities. Their efforts leverage, our proven strength and development, regulatory affairs, and commercial excellence to drive our next phase of growth.

我們卓越的商業執行力證明了我們有能力建立一家可持續發展且有韌性的公司。我們的企業發展團隊專注於建立強大的管道，並積極識別和評估一系列內部和外部機會。他們的努力利用我們已證實的實力和發展、監管事務和商業卓越來推動我們下一階段的成長。

Our focus on serving our patients and driving exceptional commercial and financial performance is at the core of who we are and what we do. We're extremely proud to have generated over $330 million in revenue last year and finished the year with a robust $250 million on our balance sheet.

我們專注於服務患者並推動卓越的商業和財務業績，這是我們的身份和工作的核心。我們非常自豪去年創造了超過 3.3 億美元的收入，並以 2.5 億美元的強勁資產負債表結束了這一財年。

This strong financial position empowers us as we build our company for the future. Rest assured, we will be diligent stewards of our capital, strategically investing in areas where we have confidence in our ability to generate significant value for shareholders. We are building an exceptional company, one that stands out in the industry. Our future is incredibly promising, and we are poised for great success.

強勁的財務狀況為我們打造公司的未來提供了強大的力量。請放心，我們將勤勉地管理我們的資本，在我們有信心能為股東創造重大價值的領域進行策略性投資。我們正在打造一家卓越的公司，一家在業界脫穎而出的公司。我們的未來充滿希望，我們已準備好獲得巨大的成功。

I will now hand the call to Eric to share an update on our commercial performance.

現在我將把電話交給 Eric，讓他分享我們商業表現的最新情況。

Thank you, Mike. It's great to be with you all again.

謝謝你，麥克。很高興能再次和大家在一起。

Across our portfolio, we had a great fourth quarter driven by strong demand from prescribers for these first-in-class medicines that are demonstrating the clinical benefits they can offer patients. Every day we hear success stories of patients with IBS-C whose quality of life has improved thanks to IBSRELA, or CKD patients who have struggled for years to achieve target phosphorus levels are now coming into range thanks to XPHOZAH.

在我們的產品組合中，我們在第四季度取得了出色的成績，這得益於處方醫生對這些同類首創藥物的強勁需求，這些藥物正在展示出可以為患者帶來的臨床益處。每天，我們都會聽到 IBS-C 患者的成功故事，他們的生活品質由於 IBSRELA 而得到改善，或者 CKD 患者多年來一直努力達到目標磷水平，現在由於 XPHOZAH 而恢復正常。

We had a strong momentum throughout 2024 and will look to maintain that momentum in 2025 with strategic investments in areas where we believe we can drive further demand and share. Let me start with IBSRELA.

我們在 2024 年全年都保持著強勁勢頭，並將透過在我們認為可以進一步推動需求和份額的領域進行策略性投資，在 2025 年保持這一勢頭。讓我從 IBSRELA 開始。

We reported an incredibly strong quarter with more than 32% growth quarter over quarter from Q3. We completed our salesforce expansion at the end of Q3, and they were trained and in the field for all of Q4, driving that accelerated growth. Importantly, we saw growth from all our key indicators in the fourth quarter, including new and repeat writers and new and refill prescriptions. We particularly saw a notable increase in the growth of new writers. We are pleased to see that because it aligns with the expanded targeting that we implemented with the growth of our sales team.

我們報告了一個非常強勁的季度，與第三季度相比增長了 32% 以上。我們在第三季末完成了銷售隊伍的擴張，並在整個第四季度接受了培訓並在現場工作，推動了銷售團隊的加速成長。重要的是，我們看到第四季度所有關鍵指標均有所增長，包括新開處方和復開處方以及新處方和續開處方。我們特別看到新作家數量的顯著增長。我們很高興看到這一點，因為這與我們隨著銷售團隊的成長而實施的擴大目標一致。

Not only has the team focused on high riding gastroenterologists, but we've been able to expand the number of high riding non-GIs as well as a number of advanced practice providers, or APPs, which includes nurse practitioners or PAs who are heavily involved in IBS-C management for patients. We're excited about the exit trajectory coming into 2025, and as we look to maintain the momentum, we're focused on maximizing our pull through across the patient journey.

團隊不僅專注於高級胃腸病學家，而且我們還能夠擴大高級非胃腸病學家的數量以及高級執業提供者或 APP 的數量，其中包括深度參與患者 IBS-C 管理的執業護士或 PA。我們對 2025 年的退出軌跡感到興奮，並且為了保持這一勢頭，我們專注於最大限度地發揮我們在整個患者旅程中的拉動動作。

Starting with the top of the funnel, our sales team will continue to focus on driving clinical conviction and patient identification among our expanded HCP list. At the same time, we are thoughtfully increasing our investments in omnichannel communication to engage and drive action among prescribers and patients.

從漏斗頂部開始，我們的銷售團隊將繼續致力於在擴大的 HCP 名單中推動臨床信念和患者識別。同時，我們正在深思熟慮地增加對全通路溝通的投資，以吸引和推動處方人員和患者採取行動。

Initially, our marketing efforts focused on the prescribers, and we saw early on that they were highly responsive to IBSRELA's safety and efficacy profile and our marketing messages. We have also learned that IBSC patients are incredibly engaged, seeking new information and connecting with patients alike, while also exploring options to manage their condition.

最初，我們的行銷工作重點是處方人員，我們很早就發現他們對 IBSRELA 的安全性和有效性概況以及我們的行銷訊息反應非常積極。我們也了解到，IBSC 患者的參與度非常高，他們尋求新的資訊並與患者建立聯繫，同時也探索管理病情的選擇。

We will be increasing our investment in direct to patient communication in 2025 to empower patients to learn more about their condition and the different options to treat their symptoms of IBSC. At the same time that we are driving more patients at the top of the funnel, we will be increasing our focus on pulling those patients through to the bottom of the funnel so more patients can access IBSRELA.

2025 年，我們將增加對直接與患者溝通的投資，使患者能夠更多地了解他們的病情以及治療 IBSC 症狀的不同選擇。在我們推動更多患者進入漏斗頂端的同時，我們將更加重視將這些患者拉到漏斗底端，以便更多患者能夠使用 IBSRELA。

We've got an incredible patient services program with our Ardelyx Assist, and it performed phenomenally in the fourth quarter. We believe that we can do more, and so in 2025, we'll be investing in our patient services programs and notably expanding our access manager team. This is a field-based team that is part of Ardelyx Assist that will focus on pulling through those appropriately identified patients. This team will work with physicians' offices to help understand the process for prior authorizations and make sure that barriers are addressed so patients can have access to our medicines.

我們透過 Ardelyx Assist 推出了一項令人難以置信的患者服務計劃，該計劃在第四季度表現出色。我們相信我們可以做得更多，因此在 2025 年，我們將投資於我們的患者服務計劃，並專注於擴大我們的訪問經理團隊。這是一支現場團隊，是 Ardelyx Assist 的一部分，其工作重點是救治那些已被適當識別的患者。團隊將與醫生辦公室合作，幫助了解事先授權的流程，並確保消除障礙，以便患者可以獲得我們的藥物。

We have always had pull through rates that are in line with our industry. However, we recognize that we can do more, and we have the unique ability to address this opportunity because of the Ardelyx Assist program that helps connect healthcare providers, pharmacies, patients, and payers. I'm excited about the incredible potential that IBSRELA has to help many more patients with IBSC and the continued growth we expect in 2025.

我們的拉動率始終與我們的行業保持一致。然而，我們認識到我們可以做得更多，並且我們有獨特的能力來抓住這個機會，因為 Ardelyx Assist 計劃可以幫助連接醫療保健提供者、藥房、患者和付款人。我很高興 IBSRELA 能夠幫助更多 IBSC 患者，我們預計 2025 年將繼續成長。

Moving on to XPHOZAH, the performance that we delivered in 2024 demonstrates just how important this medicine is for patients. XPHOZAH's differentiated mechanism of action and strong safety and efficacy profile were attractive to prescribing physicians since launch in late 2023, but the real world experience that physicians have with XPHOZAH demonstrates the significant impact that it can have.

說到 XPHOZAH，我們在 2024 年的表現證明了這種藥物對患者的重要性。XPHOZAH 的差異化作用機制和強大的安全性和有效性自 2023 年底推出以來就吸引了開處方的醫生，但醫生對 XPHOZAH 的實際經驗證明了它可以產生的重大影響。

More patients are now able to achieve target phosphorus levels thanks to the addition of XPHOZAH to their treatment regimen for hyperphosphatemia, an innovation that came nearly 50 years after the introduction of phosphate binders.

由於 XPHOZAH 在高磷血症治療方案中添加，更多患者現在能夠達到目標磷水平，這是磷酸鹽結合劑問世近 50 年後出現的一項創新。

We recognize that the question everyone is asking is what is going to happen to XPHOZAH in 2025. This is what we know today. First and most importantly, dialysis patients who are in need of XPHOZAH to lower their serum phosphorus levels have access to treatment. Today, XPHOZAH is available as it always has been, as a prescription written by a healthcare provider. The only thing that has changed is that XPHOZAH is no longer covered by Medicare Part D.

我們體認到，每個人都在問的問題是 2025 年 XPHOZAH 會發生什麼事。這就是我們今天所知道的。首先，最重要的是，需要使用 XPHOZAH 降低血清磷水平的透析患者可以接受治療。如今，XPHOZAH 仍像往常一樣，以醫療保健提供者開出的處方形式提供。唯一改變的是 XPHOZAH 不再受 Medicare Part D 的保障。

Second, our commercial approach is unchanged from last year. As with IBSRELA, our XPHOZAH team is focused on driving clinical conviction and patient identification and pulling prescriptions through to the patient. At the same time, they're helping the nephrology community and care teams to understand that their ability to prescribe XPHOZAH remains unchanged and that for the best experience, prescriptions should be sent to the Ardelyx Assist specialty pharmacy.

第二，我們的商業方式與去年相比沒有改變。與 IBSRELA 一樣，我們的 XPHOZAH 團隊專注於推動臨床信念和患者識別並將處方發送給患者。同時，他們正在幫助腎臟病學界和護理團隊了解，他們開立 XPHOZAH 處方的能力保持不變，為了獲得最佳體驗，處方應發送到 Ardelyx Assist 專科藥房。

Most importantly, we do not want physicians to change their prescribing habits based on patient coverage. Our message is to prescribe as you always have, based on the patient need, and we will adjudicate patient access and affordability on our end. That directive will ultimately support our long-term growth expectations.

最重要的是，我們不希望醫生根據患者的覆蓋範圍來改變他們的開藥習慣。我們的訊息是，根據患者的需要，像往常一樣開處方，我們將在我們這邊裁定患者的治療機會和可負擔性。該指令最終將支持我們的長期成長預期。

For us, ensuring patients have access to therapies is both a moral obligation and a strategic opportunity. We have seen the benefit that XPHOZAH offers, and we are fortunate that the business we've structured and the approach that we have taken allows us to ensure access to our medicines regardless of fare. With this approach, we are confident that we can deliver significant growth on our path to $750 million at peak.

對我們來說，確保患者能夠獲得治療既是道德義務，也是策略機會。我們已經看到了 XPHOZAH 帶來的好處，而且我們很幸運，我們所建立的業務和所採取的方法使我們能夠確保無論票價如何都能獲得我們的藥品。透過這種方法，我們有信心在通往 7.5 億美元的巔峰道路上實現顯著成長。

It is too early for us to share any meaningful commentary on the first quarter, but I can share a few thoughts. The first thing that I looked for when we entered January was if our processes were operating as planned, and there are 4 key patient paths that we have been monitoring.

現在我們就第一季發表任何有意義的評論還為時過早，但我可以分享一些想法。進入一月份，我首先要關注的是我們的流程是否按計劃進行，我們一直在監控 4 條關鍵的患者路徑。

First, is an existing patient who was covered by Medicare still on therapy through our patient assistance program in 2025 if they qualify? Second, is an existing non-Medicare patient still receiving a revenue generating script? Third is a new qualifying Medicare patient able to access XPHOZAH through our patient assistance program. And fourth is a new non-Medicare patient receiving a revenue generating script. The answer in all 4 of these scenarios is yes. So, the systems and processes that we put in place in anticipation of this change are working as designed.

首先，如果符合條件，現有享有醫療保險的患者在 2025 年是否仍可以透過我們的病患援助計畫接受治療？其次，現有的非醫療保險患者是否仍在接受創收處方？第三位是符合資格的新醫療保險患者，他們可以透過我們的患者援助計劃獲得 XPHOZAH。第四是新的非醫療保險患者接受創收處方。這 4 種情形的答案都是肯定的。因此，我們為應對這項變化而建立的系統和流程正在按設計運作。

At this point we're staying very close to all the stakeholders to quickly learn and address any concerns that may arise. We are connecting with prescribers through every avenue we can to reinforce our message that the access path for XPHOZAH is unchanged. Our early indicators are in line with our expectations, and we'll share more in the months ahead as we have additional data available.

此時，我們與所有利害關係人保持密切聯繫，以便快速了解並解決可能出現的任何問題。我們正在透過一切可能的管道與處方人員聯繫，以強調我們的訊息：XPHOZAH 的獲取路徑沒有改變。我們的早期指標符合我們的預期，隨著我們獲得更多數據，我們將在未來幾個月分享更多資訊。

I have a tremendous amount of confidence in our team's ability to deliver on our priorities for this year. They are focused, empowered, and a high performing team. We are investing across the commercial organization to strengthen our position in the market, support patients along their journey, and accelerate our growth momentum in the years ahead.

我對我們團隊完成今年任務的能力充滿信心。他們是一支專注、有權力且有效率的團隊。我們正在對整個商業組織進行投資，以加強我們在市場上的地位，為患者提供全程支持，並在未來幾年加速我們的成長勢頭。

I will now turn it over to Justin.

現在我會把話題交給賈斯汀。

Thank you, Eric.

謝謝你，埃里克。

Earlier in January, we announced our product revenue and cash position. So I use this as an opportunity to review that material and highlight additional key financials from both the fourth quarter and full year 2024, as well as offer some thoughts on 2025.

今年一月初，我們公佈了我們的產品收入和現金狀況。因此，我利用這個機會回顧這些資料，並重點介紹 2024 年第四季和全年的其他關鍵財務數據，並對 2025 年提出一些想法。

We had total revenues of $116.1 million in the fourth quarter of 2024, driven by growth in product sales. On a full year basis, we reported total revenues of $333.6 million in 2024 compared to $124.5 million in the prior year. Our performance was driven by strong year to year growth for IBSRELA and the exceptional launch of XPHOZAH.

受產品銷售成長的推動，我們在 2024 年第四季的總營收為 1.161 億美元。以全年計算，我們報告 2024 年的總收入為 3.336 億美元，而上一年為 1.245 億美元。我們的業績得益於 IBSRELA 的逐年強勁成長以及 XPHOZAH 的出色推出。

During the fourth quarter of 2024, we recorded IBSRELA net product sales revenue of $53.8 million, nearly double the same period of 2023, and an increase of over 32% quarter over quarter from Q3. Our growth was driven by several factors including strong patient demand, the completion of our field-based sales team expansion, and an improvement in our gross and net deduction, which was 28.5% for the fourth quarter. On an annual basis, we recorded $158.3 million of IBSRELA net product sales revenue in 2024 compared to $80.1 million in the prior year.

2024 年第四季度，我們記錄的 IBSRELA 淨產品銷售收入為 5,380 萬美元，幾乎是 2023 年同期的兩倍，較上季成長超過 32%。我們的成長受到多種因素的推動，包括強勁的患者需求、我們現場銷售團隊擴張的完成以及我們的毛利和淨扣除額的改善（第四季度為 28.5%）。以年度計算，我們在 2024 年錄得 1.583 億美元的 IBSRELA 淨產品銷售收入，而前一年為 8,010 萬美元。

We also recorded $57.2 million in net product sales of XPHOZAH in the fourth quarter, the increase of 11% over Q3, driven by continued demand for its first-in-class medicine. Our gross and net deductions remain consistent at 20.3% for the fourth quarter. On an annual basis, we recorded $160.9 million of US net exposure sales in 2024 compared to $2.5 million during a partial fourth quarter of 2023 following launch.

我們也記錄了第四季度 XPHOZAH 的淨產品銷售額為 5,720 萬美元，較第三季成長 11%，這得益於對其同類首創藥物的持續需求。我們第四季的總扣除額和淨扣除額保持不變，為 20.3%。以年計算，我們在 2024 年錄得 1.609 億美元的美國淨曝光銷售額，而推出後的 2023 年第四季部分銷售額為 250 萬美元。

In addition to product revenue, we also had $4.2 million in product supply and licensing revenue in the fourth quarter and $11.7 million for the full year 2024 compared to $3.8 million during the fourth quarter and $41.9 million for the full year of 2023.

除了產品收入外，我們第四季的產品供應和授權收入為 420 萬美元，2024 年全年為 1,170 萬美元，而第四季為 380 萬美元，2023 年全年為 4,190 萬美元。

As a reminder, we received non-recurring regulatory milestone payments from our collaboration partners in the fourth quarter of last year. We also recorded just over $900,000 in non-cash royalty revenue during the fourth quarter of 2024 and $2.7 million for the full year 2024.

提醒一下，我們在去年第四季從合作夥伴那裡收到了非經常性監管里程碑付款。我們也記錄了 2024 年第四季略高於 90 萬美元的非現金特許權使用費收入，以及 2024 年全年 270 萬美元的非現金特許權使用費收入。

Research and development expenses were $13.7 million for the fourth quarter of 2024 compared to $9.5 million for the same quarter of the prior year. In 2024 and 2023, R&D expenses were $52.3 million and $35.5 million respectively. The increase in R&D expenses reflects increased medical engagement with scientific communities and pediatric clinical trial activities.

2024 年第四季的研發費用為 1,370 萬美元，而去年同期為 950 萬美元。2024年及2023年，研發費用分別為5,230萬美元及3,550萬美元。研發費用的增加反映了醫學界與科學界以及兒科臨床試驗活動的參與度增加。

Selling, general administrative expenses were $76.1 million for the fourth quarter of 2024 compared to $47.8 million that were reported for the same period in the prior year. On a full year basis, total SG&A expenses were $258.7 million compared to $134.4 million in 2023. The increase was related to commercial activities for IBSRELA and XPHOZAH, including the aforementioned salesforce expansion, as well as growth of the overall corporate infrastructure to support our strategy.

2024 年第四季的銷售、一般管理費用為 7,610 萬美元，去年同期為 4,780 萬美元。全年總銷售、一般及行政開支為 2.587 億美元，而 2023 年為 1.344 億美元。這一成長與 IBSRELA 和 XPHOZAH 的商業活動有關，包括前面提到的銷售隊伍擴張，以及為支持我們策略而增加的整體公司基礎設施的成長。

We had net income of approximately $4.6 million or $0.02 per share in the fourth quarter of 2024 compared to a net loss of $28.8 million or $0.12 per share in the same period of the prior year. The net income for the fourth quarter of 2024 included $10.8 million in combined non-cash expenses from share-based compensation and net non-cash expense related to the monetization of hyperphosphatemia sales royalties in Japan.

2024 年第四季度，我們的淨收入約為 460 萬美元或每股 0.02 美元，而去年同期的淨虧損為 2,880 萬美元或每股 0.12 美元。2024 年第四季的淨收入包括 1,080 萬美元的股權激勵非現金支出以及與日本高血磷症銷售特許權使用費貨幣化相關的淨非現金支出。

Our net loss for the full year 2024 was $39.1 million or $0.17 per share, which included $41.8 million for non-cash expenses from share-based compensation and net non-cash expense related to the monetization of hyperphosphatemia sales royalties in Japan.

我們 2024 年全年淨虧損為 3,910 萬美元，即每股 0.17 美元，其中包括股權激勵產生的非現金費用 4,180 萬美元以及與日本高磷血症銷售特許權使用費貨幣化相關的淨非現金費用。

As of December 30, 2024, our total cash, cash equivalents, and short-term investments increased to $250.1 million as compared to $184.3 million at the end of 2023. This includes $49.7 million in net proceeds that we drew in October from our term loan agreement with SLR Capital, as well as operating cash flows generated during the second half of the year.

截至 2024 年 12 月 30 日，我們的現金、現金等價物和短期投資總額從 2023 年底的 1.843 億美元增加至 2.501 億美元。這包括我們 10 月從與 SLR Capital 簽訂的定期貸款協議中獲得的 4,970 萬美元淨收益，以及今年下半年產生的營運現金流。

Before I close, I want to share some of our financial expectations for 2025 and beyond. From a revenue perspective, we anticipate continued long-term growth for both IBSRELA and XPHOZAH.

最後，我想分享一下我們對 2025 年及以後的一些財務預期。從收入角度來看，我們預計 IBSRELA 和 XPHOZAH 都將繼續長期成長。

We continue to expect IBSRELA to achieve greater than $1 billion in net product sales annually prior to patent expiry. As we announced in January, we expect to deliver between $240 MILLION and $250 million in net product sales revenue for IBSRELA in 2025, driven by our expanded sales force, as well as investments in patient pull through in our omnichannel communications efforts. We also expect our gross and net deduction to follow a similar trend that we have seen over the past two years, being 30%, plus or minus 5% and less favorable in the first quarter and more favorable by the fourth quarter.

我們繼續預期 IBSRELA 在專利到期前每年的淨產品銷售額將超過 10 億美元。正如我們在一月份宣布的那樣，我們預計 2025 年 IBSRELA 的淨產品銷售收入將達到 2.4 億至 2.5 億美元，這得益於我們擴大的銷售隊伍以及對全通路溝通工作中患者拉動的投資。我們也預計，我們的總扣除額和淨扣除額將與過去兩年的趨勢類似，為 30%，上下浮動 5%，第一季的扣除額較少，而第四季度的扣除額較多。

As we relate to XPHOZAH, as you have heard from Mike and Eric, we continue to have significant expectations for XPHOZAH, driven by the clear unmet need for CKD patients to have another option to lower their serum phosphorus to target levels. We expect that XPHOZAH will achieve $750 million in annual net sales revenue prior to patent expiry.

就 XPHOZAH 而言，正如您從 Mike 和 Eric 那裡聽到的，我們繼續對 XPHOZAH 抱有很大的期望，這是因為 CKD 患者明顯需要另一種選擇來將血清磷降低到目標水平。我們預計，XPHOZAH 在專利到期前將實現 7.5 億美元的年淨銷售收入。

As I think we have demonstrated in the past, we provide guidance that is thoughtful and reflects our expectations of the business. We also only give information when we feel that we are in a position to give an accurate view. As such, we will not be sharing 2025 XPHOZAH revenue guidance at this time. One thing I can share is that we expect to XPHOZAH gross debt deduction in 2025 to be less favorable than we saw in 2024 due to the change in our payer mix.

我認為，正如我們過去所展示的那樣，我們提供的指導是深思熟慮的，並反映了我們對業務的期望。我們也僅當我們認為能夠給予準確的觀點時才會提供資訊。因此，我們目前不會分享 2025 年 XPHOZAH 收入指引。我可以分享的一件事是，由於付款人結構的變化，我們預計 2025 年 XPHOZAH 總債務扣除額將不如 2024 年那麼有利。

We will also be increasing our SG&A expenses by approximately $10 million per quarter in 2025 as compared to the fourth quarter of 2024's run rate to grow both IBSRELA and XPHOZAH. Those investments include the additional market access team members and the omni-channel communications that Eric spoke to, as well as increased costs associated with our patient assistance program following the elimination of Medicare Part D coverage for XPHOZAH.

與 2024 年第四季的運行率相比，我們還將在 2025 年每季增加約 1,000 萬美元的銷售、一般和行政費用，以促進 IBSRELA 和 XPHOZAH 的成長。這些投資包括 Eric 談到的額外的市場准入團隊成員和全通路溝通，以及在取消 XPHOZAH 的 Medicare Part D 保險後與我們的患者援助計劃相關的成本增加。

You should note that our royalty obligation payable to AstraZeneca is expected to be fully satisfied in 2025, which should generate some gross margin favorability in the second half of this year. We are excited to be making these investments to grow our business, and we will do so based on a strong cast position of over $250 million. We feel very confident we are in a position to fund our expected operations from our current cast position. We are building a great company and expect to create significant shareholder value this year by delivering on our key strategic priorities.

您應該注意到，我們向阿斯特捷利康支付的特許權使用費義務預計將在 2025 年完全履行，這將在今年下半年產生一些毛利率優勢。我們很高興能夠進行這些投資來發展我們的業務，而且我們將以超過 2.5 億美元的強大實力為基礎來實現這一目標。我們非常有信心，憑藉我們目前的資產狀況，我們能夠為預期的營運提供資金。我們正在打造一家偉大的公司，並期望今年透過實現我們的關鍵策略重點來創造顯著的股東價值。

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

說完這些，我就把麥克風交還給麥克。

Thanks Justin.

謝謝賈斯汀。

Since our founding in 2007, every year, no matter the challenges we've encountered, has made us better and more resolute in our mission. 2024 was an incredible year for Ardelyx, and the patients we serve are benefiting from our medicines.

自 2007 年成立以來，每年，無論我們遇到什麼挑戰，都會讓我們變得更好，更堅定地完成我們的使命。 2024 年對 Ardelyx 來說是不可思議的一年，我們服務的患者正在從我們的藥物中受益。

We protected patient access to XPHOZAH. We doubled down on our commitment to IBS-C patients with IBSRELA. We strengthened our financial foundation to ensure future growth, and most importantly, we never deviated from our values.

我們保護患者對 XPHOZAH 的存取。我們加倍致力於為 IBS-C 患者提供 IBSRELA 服務。我們加強了財務基礎以確保未來的成長，最重要的是，我們從未偏離我們的價值觀。

The path ahead is clear and filled with promise. We are fully committed to our priorities, driving as well as growth, executing on the exposing strategy, building a pipeline of impactful medicines, and achieving strong financial and commercial performance. I'm truly excited about our future. We'll keep you informed about our progress in the quarters ahead.

前方的道路清晰且充滿希望。我們全力致力於我們的優先事項、推動成長、執行曝光策略、建立有影響力的藥物管道，並實現強勁的財務和商業業績。我對我們的未來感到非常興奮。我們將隨時向您通報未來幾季的進度。

I will now in the call to questions operator.

我現在將接聽電話並回答問題。

(Operator Instructions)

（操作員指令）

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

So my question relates to the IBSRELA guidance. So $240 million to $250 million, if you do the math, I mean it seems quite conservative, about 5% on quarter growth at the midpoint. I mean, I can understand the low end being conservative, but the high end, I mean, even if you were to assume modest decrease versus what you saw in '24, the 32%. It seems like the upper end of the guidance could be quite a bit higher, so I'm just curious if you could comment on the thinking around the $240 million to $250 million.

我的問題與 IBSRELA 指導有關。因此，如果你算一下，2.4 億到 2.5 億美元似乎相當保守，中間值季度成長率約為 5%。我的意思是，我可以理解低端是保守的，但高端，我的意思是，即使你假設與 24 年相比有所下降，也是 32%。看起來指導價的上限可能會高出不少，所以我很好奇您是否可以對 2.4 億至 2.5 億美元左右的想法發表評論。

I think as we've seen this business grow and the overall contraction that we see in the IBS-C market writ large in the first quarter, we want to see the impact of that. Historically, if you look at IBS-C scripts, they go down about 10%. We've not experienced that historically, and that's probably more due to volume compared to the growth that we have now, so we really want to navigate that first before we give you anything that's any different than the $240 million to $250 million. Again, as Justin said in his comments, and you know I think you've experienced our guidance in the past, we'll give you numbers that we're confident that we're going to hit.

我認為，隨著我們看到這項業務的成長以及第一季 IBS-C 市場整體萎縮的現象，我們希望看到其影響。從歷史上看，如果你看看 IBS-C 腳本，它們會下降約 10%。我們以前沒有經歷過這種情況，這可能更多的是由於數量而不是我們現在的增長，所以在給你任何不同於 2.4 億到 2.5 億美元的東西之前，我們真的希望先解決這個問題。再說一次，正如賈斯汀在他的評論中所說的那樣，你知道我認為你過去已經體驗過我們的指導，我們會給你我們有信心達到的數字。

And then on the on the $750 million with XPHOZAH, so can you just clarify, is this based on using 2033 Hatch-Waxman 14 years from 2019 approval, or is it based on an earlier date without Hatch-Waxman just based on the core IP? Can you just clarify what timeline you're referencing there please?

然後關於 XPHOZAH 的 7.5 億美元，您能否澄清一下，這是基於使用 2019 年批准後的 14 年後的 2033 年 Hatch-Waxman 法案，還是基於沒有 Hatch-Waxman 法案的更早日期，僅基於核心 IP？您能否澄清一下您所參考的時間表？

Yeah, it includes the extension of the Hatch-Waxman.

是的，它包括 Hatch-Waxman 的擴展。

And then last one on the on the BD front, is should we have an expectation that we could see some sort of a licensing of a new product this year or that's to be determined?

然後關於 BD 方面的最後一個問題是，我們是否應該預期今年可以看到某種新產品的授權，或者這是否還有待確定？

To be determined. We're going to bring in the team that we've built, we talked about Mike Kelleher and the team that he's established and what they're looking at now. Certainly, our objective is to continue to build the pipeline and for the right opportunity, but if it's here this year, we certainly would announce that.

有待確定。我們將引入我們已經建立的團隊，我們討論了麥克凱萊赫和他建立的團隊以及他們現在正在關注的事情。當然，我們的目標是繼續建立管道並尋找合適的機會，但如果今年就能實現，我們肯定會宣布這一點。

Dennis Ding, Jefferies.

丹尼斯·丁（Dennis Ding），傑富瑞（Jefferies）。

We have one on XPHOZAH and another follow up on IBSRELA. So for XPHOZAH, thanks for your comments and prepared remarks, it's very encouraging to hear. So we're seeing scripts potentially bottoming out, but curious what you're seeing real time in the field now that we're towards the end of February and if doctors are broadly prescribing XPHOZAH in the same way as they did in 2024. I guess the key question is from a volume perspective, do you think we are at the bottom and then as a follow up?

我們有一篇關於 XPHOZAH 的文章，還有一篇關於 IBSRELA 的後續文章。因此，對於 XPHOZAH，感謝您的評論和準備好的評論，聽到這些非常令人鼓舞。因此，我們看到處方藥數量可能觸底，但我很好奇，現在已接近 2 月底，您在該領域的實時情況如何，以及醫生是否像 2024 年一樣廣泛開具 XPHOZAH 處方。我想關鍵問題是從數量的角度來看，您是否認為我們已經處於底部，然後進行後續行動？

Sure, just a brief comment from me then. I'll comment is the entire process management market has been challenged disrupted as binders move into the bundle. And how that operates within the DOs getting the patients, all those things. So we're working within that context, right, so think about that. And the message is Eric said in his comments that we're trying to enforce with physicians, the directive that keep doing what you've been doing historically, and we will adjudicate on our end all the issues that we're coverage for Medicare patients.

當然，我只是想簡單評論一下。我想說的是，隨著活頁夾進入捆綁領域，整個流程管理市場受到了挑戰和乾擾。以及它在 DO 內部如何運作以獲取患者等所有這些事情。所以我們是在這樣的背景下工作的，對的，所以想想吧。艾瑞克在評論中表示，我們正試圖向醫生們強制執行指令，繼續做你們過去一直在做的事情，我們將在我們這邊裁決所有我們為醫療保險患者提供的保障問題。

Whether or not we're at the bottom, I think I certainly wouldn't be in a position to predict that. We feel really good about the performance, and I think if Eric can comment a little bit more on the sort of four areas that he's been tracking to ensure that confidence continues.

無論我們是否處於谷底，我認為我肯定無法預測這一點。我們對錶現感到非常滿意，我認為埃里克是否可以就他一直關注的四個領域再多發表一些評論，以確保這種信心能夠持續下去。

Yeah, thanks, Dennis. I agree with Mike. I think it is too early to say whether or not we've been at the bottom. What I can say is our message has certainly been well received with regards to access continuing for XPHOZAH for these patients.

是的，謝謝，丹尼斯。我同意麥克的觀點。我認為現在說我們是否已經觸底還為時過早。我可以說的是，關於讓這些患者繼續獲得 XPHOZAH 治療，我們的資訊確實受到了熱烈歡迎。

And again, it was really important that we make sure that we were confident that the plan that we have and those four patient groups and pathways that they being able to kind of flow through and receive access. And very early on, we saw that those 4 patient paths, they were successful and that patients were able to have access. So, we're continuing to see that as we saw from the beginning part of this quarter, and we just continue to be encouraged that we're continuing to see that flow through.

再次強調，我們必須確保我們的計劃以及這四個患者群體和途徑能夠順利通過並獲得治療，這一點非常重要。我們很早就發現，這 4 條患者治療路徑都取得了成功，患者能夠獲得治療。因此，正如我們從本季度初看到的那樣，我們繼續看到這種情況，我們繼續感到鼓舞，我們繼續看到這種流動。

As Mike said, there is a lot of activity right now with regards to the binders being in the bundles and the DOs having to work through that. So we're certainly empathetic to the challenges that they're going through, and we just continue to remain focused on ourselves and making sure that physicians are confident that there continues to be access for XPHOZAH and those patients out there in need can have access to it. So we're encouraged by seeing that and we're just going to continue to push forward from there.

正如 Mike 所說，目前有很多與文件捆綁以及 DO 必須處理的文件相關的活動。因此，我們當然同情他們所經歷的挑戰，我們只是繼續關注自己，並確保醫生們相信 XPHOZAH 能夠繼續使用，並且有需要的患者能夠使用。看到這一點我們感到很受鼓舞，我們會繼續努力向前邁進。

And then my follow up on this, it's a 3-parter, so I apologize for that, but you started two Phase 2 trials in Parkinson's and CF associated constipation, you talk about the rationale behind those two very specific populations and if they are part of your $1 billion dollar peak sales guidance, or if these are incremental opportunities and perhaps help us size those markets for us.

然後我對此進行跟進，這是一個三部分的問題，所以我對此表示歉意，但是您啟動了帕金森氏症和 CF 相關便秘的兩項 2 期試驗，您討論了這兩個非常特殊的人群背後的理由，以及他們是否是您 10 億美元峰值銷售指導的一部分，或者這些是否是增量機會，也許可以幫助我們確定這些市場的規模。

Sure. And those are investigator-sponsored trials which are certainly common in the industry, so those are not ones that we sponsor. And I think if you look at it, constipation is many different ideologies, Parkinson's being one that's common, and you know, we're excited to see what those results will look like. And no, that's not part of the billion.

當然。這些都是由研究者發起的試驗，這在業界很常見，所以這些不是我們贊助的。我認為，如果你看一下，你會發現便秘有很多不同的症狀，帕金森氏症是其中一個常見的症狀，你知道，我們很高興看到這些結果會是什麼樣的。不，這並不在十億之內。

Laura Chico, Wedbush Securities.

勞拉‧奇科（Laura Chico），韋德布希證券公司。

One on XPHOZAH, apologies if I missed this. Are there any quantitative metrics you could share just with respect to kind of the retention of patients now in 2025 and any possibility you can kind of frame context around the quantification of free drugs in the quarter so far.

一篇關於 XPHOZAH 的文章，如果我錯過了，請見諒。您能否分享一些關於 2025 年患者保留情況的定量指標，以及您是否可以對迄今為止本季度免費藥品的量化情況進行概括。

Yeah, I think the latter question it's too early for that, Laura, as people are going through this process that we described in our prepared remarks. I think I'll ask Eric to talk about sort of the first two groups of patients that came in from '24 into '25 and seeing that they're still on therapy. That's probably the only thing that we can comment on at this stage.

是的，勞拉，我認為後一個問題現在回答還為時過早，因為人們正在經歷我們在準備好的發言中描述的這個過程。我想我會請艾瑞克談談 2024 年至 2025 年入院的前兩組患者的情況，以及他們目前仍在接受治療的情況。這可能是我們現階段唯一可以評論的事情。

Yeah. As Mike said, we're not going to be able to get into specifics in terms of quantifying it, but I can confirm that we had patients that were on XPHOZAH in 2024 covered by Medicare Part D. And as they came into 2025, and obviously, we re-verified their benefits and they are able to qualify for our patient assistance program, they have been given access to XPHOZAH. So those patients that receiving it through Medicare Part D in 2024 now have access to our patient assistance program if they qualify and are continuing to have access in 2025.

是的。正如麥克所說，我們無法具體量化，但我可以確認，2024 年我們有患者使用 XPHOZAH，並且享有 Medicare Part D 的保障。到了 2025 年，我們顯然重新驗證了他們的福利，他們有資格參加我們的患者援助計劃，並且他們可以使用 XPHOZAH。因此，那些在 2024 年透過 Medicare Part D 獲得援助的患者如果符合條件，現在就可以享受我們的患者援助計劃，並將在 2025 年繼續享受該計劃。

And then those patients that were receiving it through their commercial or their non-Medicare benefit, again, going through that re-verification process in the January time frame. If their coverage does continue, we've been able to confirm that they still continue to have access to XPHOZAH in 2025.

然後，那些透過商業或非醫療保險福利獲得治療的患者將在 1 月再次經歷重新驗證過程。如果他們的保險能夠繼續，我們可以確認他們在 2025 年仍然可以繼續獲得 XPHOZAH。

And then maybe just one for Justin, and I think I missed this. With the SLR term loan draw, I think it's about $50 million, where are the primary proceeds going to be applied? Is it more for infrastructure, SDA expansion, any other commentary there?

然後也許只給賈斯汀一個，我想我錯過了這個。透過 SLR 定期貸款提取，我認為金額約為 5000 萬美元，主要收益將用在何處？它是否更多地用於基礎設施、SDA 擴展，還有其他評論嗎？

Sure. We've always been very prudent in our capital raising strategies, and so we had an opportunity with SLR Capital in October to add that $49.7 million to our balance sheet to give us over $250 million. So we are very well resourced. It's at a very competitive interest rate, and so we want to take advantage of that as well as extend the runway of our interest only period until July of 2028.

當然。我們在融資策略上一直非常謹慎，因此我們在 10 月與 SLR Capital 合作，將 4,970 萬美元添加到我們的資產負債表中，使我們的資產負債表超過 2.5 億美元。因此我們的資源非常充足。它的利率非常有競爭力，因此我們希望利用這一點，並將只付利息的期限延長至 2028 年 7 月。

So it's somewhat of a strategic move to give us plenty of opportunity to give Eric the ability to do what he needs to do to expand the team, to grow a business, and to give our company the opportunity to build a pipeline which we've touched on in the past, but we're going to be methodical and patient. But again, with a strong balance sheet now, with plenty of runway, we have that flexibility to build a great company.

因此，這在某種程度上是一種策略性舉措，為我們提供充足的機會，讓艾瑞克有能力做他需要做的事情，以擴大團隊，發展業務，並讓我們的公司有機會建立我們過去曾涉及過的管道，但我們會循序漸進、耐心等待。但現在我們擁有強勁的資產負債表，充足的發展空間，我們有彈性來打造一家偉大的公司。

Joseph Thome, TD Cowen.

約瑟夫·托米（Joseph Thome），TD Cowen。

Maybe on the first one, on XPHOZAH, I guess just how familiar are the treating physicians with the bundling dynamics? I guess when we do our (inaudible) calls, some physicians are acutely aware of reimbursement dynamics and others seemingly aren't at all. They just kind of write the prescription that goes off. So how often are you finding that you're having to correct physician behaviors and kind of remind them just kind of keep doing things as normal?

也許在第一個問題上，關於 XPHOZAH，我猜治療醫生對捆綁動態有多熟悉？我想，當我們打電話時，有些醫生會敏銳地意識到報銷動態，而其他醫生似乎根本沒有意識到。他們只是開了一些不合適的處方。那麼您發現您需要多久糾正一次醫生的行為並提醒他們繼續正常做事呢？

And then maybe second on the BDPs, what sort of assets are you looking for? You've had good progress with the prior authorization, commercially with some of your assets. Would you look for a commercial agent or you want to expand the development plan?

然後也許第二個關於 BDP 的問題，您正在尋找什麼樣的資產？您在先前授權方面已在部分資產的商業化方面取得了良好進展。您會尋找商業代理嗎或您想擴大發展計劃嗎？

Let me address the second first and I'll ask Eric to speak to what you just articulating in terms of the turmoil that we see out there is exactly what you pointed to. But in terms of what we're looking at, obviously, staying within our therapeutic areas is the first strategic consideration that Mike and the team are looking at. And you know, whether the specific types that we're going to be looking at, I think, is premature to address that we're going to look at something that makes sense within our team with the skill sets that we have across the organization and the commercial team, but building a broad and robust pipeline is the objective.

讓我先談談第二個問題，然後我會請艾瑞克談談你剛才所說的關於我們所看到的動盪的情況正是你所指出的。但就我們所考慮的問題而言，顯然，留在我們的治療領域是麥克和團隊考慮的首要策略因素。而且您知道，我認為，現在討論我們將要研究的具體類型還為時過早，我們將研究在我們的團隊中有意義的東西，以及我們整個組織和商業團隊所擁有的技能，但建立廣泛而強大的管道是我們的目標。

Yeah, and then with regards to your first question, Joe, I think it's a good one. You know what we have learned is the vast majority of the physicians are aware of the bundle situation. But to your point, it's really the DOs that have absorbed -- that really have absorbed this as we moved into 2025.

是的，關於你的第一個問題，喬，我認為這是一個很好的問題。您知道，我們了解到的是，絕大多數醫生都知道捆綁的情況。但正如您所說，實際上是 DO 在我們進入 2025 年時真正吸收了這一點。

And for us, it really allows us to keep a very simple message to the physicians. We know that they do not discern between Medicare or non-Medicare or based on payer coverage. So for us, our message continues to be simple and straightforward as it was in 2024, that regardless of coverage that they can feel confident that they will have access to XPHOZAH, and that's exactly what we're seeing in 2025.

對我們來說，它確實使我們能夠向醫生傳達一個非常簡單的訊息。我們知道他們無法區分醫療保險和非醫療保險，也無法根據付款人的保障範圍進行區分。因此對我們來說，我們的資訊仍然像 2024 年一樣簡單明了，那就是無論覆蓋範圍如何，他們都可以確信他們能夠獲得 XPHOZAH，而這正是我們在 2025 年所看到的。

(Operator Instructions)

（操作員指令）

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

So quick on XPHOZAH, given the new reimbursement dynamic, I was curious what factors could allow you to meet or even exceed the $750 million peak sales guide for this product and also wanted to know if you could elaborate a bit more on some of the strategies and resources you're using to make sure Medicare patients continue to stay on XPHOZAH therapy if they qualify.

關於 XPHOZAH，鑑於新的報銷動態，我很好奇哪些因素可以讓您達到甚至超過該產品 7.5 億美元的峰值銷售指南，也想知道您是否可以詳細說明一下您用來確保符合條件的醫療保險患者繼續接受 XPHOZAH 治療的一些策略和資源。

Sure, I mean, to the last part first is that is up to the physician, right. And the strong messaging that Eric has been talking about keep doing what you're doing and the clear clinical benefit that XPHOZAH therapy is demonstrated in helping patients reach their target levels, which had previously many have not been able to do, but with XPHOZAH, they are. And in terms of the first part of your question, I'll ask Eric to address that.

當然，我的意思是，最後一部分首先取決於醫生，對吧。Eric 一直在強調的強有力的信息是繼續做你正在做的事情，XPHOZAH 療法在幫助患者達到目標水平方面表現出明顯的臨床益處，以前許多人都無法做到這一點，但透過 XPHOZAH，他們做到了。關於你問題的第一部分，我會請艾瑞克來回答。

Yeah, so we -- as we think about for the patient's journey, we're very proud of our Ardelyx Assist team and the service that they're able to provide for physicians and for patients out there, and that's one of the reasons why we decided to expand that to be more of a field facing team in 2025.

是的，所以當我們考慮患者的旅程時，我們為我們的 Ardelyx Assist 團隊以及他們能夠為醫生和患者提供的服務感到非常自豪，這也是我們決定在 2025 年將其擴展為更面向現場的團隊的原因之一。

So, we think about the levers for us, again, it's very simple messaging that we continue to have access regardless of payer coverage or patients continue to have access regardless of payer coverage. We continue to make sure that we've got a solid marketing plan. We're out there with physicians. We're in the community, peer to peer programming, meeting them at conferences where we know that they like to receive information and they like to engage with the teams.

因此，我們考慮了對我們來說的槓桿，再次強調，這是一個非常簡單的信息，即無論付款人是否覆蓋，我們都將繼續享有訪問權，或者無論付款人是否覆蓋，患者都將繼續享有訪問權。我們將繼續確保我們有一個完善的行銷計劃。我們和醫生們一起在那裡。我們身處社區，進行點對點編程，在會議上與他們會面，我們知道他們喜歡接收訊息，並且喜歡與團隊互動。

And then again, the Ardelyx Assist to be able to work with the offices to help triage those patients as they work through their journey to able to have access, and you know, we're confident that works and we're seeing a lot of traction there and access is flowing through in 2025. So that's what's really giving us the confidence that we'll be able to achieve that, whether it's having access in the non-Medicare segments and then also patients being able to qualify for a patient assistance program if they're Medicare patients.

再次，Ardelyx Assist 能夠與辦公室合作，幫助對這些患者進行分類，使他們能夠在整個旅程中獲得治療，你知道，我們相信這是有效的，我們看到了很多進展，到 2025 年，治療服務將會順利開展。所以這才真正讓我們有信心實現這一目標，無論是在非醫療保險領域獲得醫療服務，還是如果患者是醫療保險患者，那麼他們也能有資格享受患者援助計劃。

And last one for me, I noticed you're getting solid traction with the recent IBSRELA field force expansion. Just thinking ahead, are there any triggers or milestones that might encourage you to do additional field force expansion either for ISBRELA or XPHOZAH?

對我來說最後一個是，我注意到您最近在 IBSRELA 實地部隊擴張方面獲得了堅實的推動力。只是展望未來，是否存在任何觸發因素或里程碑可能會鼓勵您為 ISBRELA 或 XPHOZAH 進行額外的現場部隊擴展？

I mean, we always considered all opportunities to do and deliver more and better to our patients. I think, as Eric mentioned, increasing the access team with the field-based access managers is a critical next step. Maybe you can talk a little bit more about that, Eric, with the pull through.

我的意思是，我們始終考慮所有機會，為我們的患者提供更多更好的服務。我認為，正如 Eric 所提到的，增加由現場訪問經理組成的訪問團隊是下一步的關鍵。艾瑞克，也許你可以就此再多談一談。

Yeah. And also just to recognize that you know we just completed at the end of Q3 expansion, so we're still fairly early on in that expansion. Q4 was the first full quarter having the team there, so we still feel like there's plenty of opportunity based on the sizing that we have to get to the 124 that's out in the field right now, so we have plenty of opportunity there.

是的。另外，您要知道，我們剛完成第三季末的擴張，所以我們還處於擴張的早期階段。Q4 是球隊在那裡的第一個完整季度，因此我們仍然覺得，根據我們必須達到的規模，現在在場上的 124 人，我們在那裡有很多機會。

And then for us, it's really about how do we pull through those patients and make sure that the teams are focused in terms of their core areas of responsibility and it really felt like we could do more with regards to the field access manager team. And so, we're excited to be able to expand that team.

對我們來說，真正的問題是我們如何拯救這些病人，並確保團隊專注於他們的核心責任領域，我們真的覺得我們可以為現場訪問經理團隊做更多的事情。因此，我們很高興能夠擴大這個團隊。

That's taking place in Q1, and they will be out there in the field working with their ABD partners on the sales side starting in Q2. So, feeling very confident that we've got the right resources across the patient journey whether it's through driving clinical conviction, patient identification with the HCPs, or pulling through those patients with the officers and the payer teams.

這項工作將在第一季進行，從第二季開始，他們將在現場與 ABD 合作夥伴一起進行銷售方面的合作。因此，我們非常有信心，我們在整個患者旅程中都擁有正確的資源，無論是透過推動臨床信念、透過 HCP 進行患者識別，還是透過官員和付款人團隊來幫助這些患者。

Julian Harrison, BTIG.

朱利安·哈里森（Julian Harrison），BTIG。

On XPHOZAH, I'm wondering if you're able to share the approximate public versus private reimbursement split for the fourth quarter. Was it approximately 60 to 40 or was it notably different than that? And then, also curious if private payer access is where you want it to be for 2025 or maybe there's some near-term opportunities to grow the coverage on that side.

關於 XPHOZAH，我想知道您是否可以分享第四季度公共和私人報銷份額的大致情況。大約是 60 比 40 嗎，或與此有明顯差異？然後，同樣好奇的是，您是否希望在 2025 年實現私人付款人訪問，或者是否存在一些近期機會來擴大這方面的覆蓋範圍。

What I think is a confident number that we can say is a 60/40 split between Medicare and non-Medicare. The non-Medicare is more than commercial rents. Medicare, it's Medicaid Commercial, TriCare, VA, and Native American Affairs. So that's -- those are the five pillars of non-Medicare.

我認為可以肯定地說，醫療保險和非醫療保險的比例是 60/40。非醫療保險費用高於商業租金。醫療保險，包括商業醫療補助、TriCare、退伍軍人事務部和美國原住民事務部。這就是非醫療保險的五大支柱。

In terms of expanding access on the commercial side, remember given that we don't have rebates, we don't have discounts, and that's why we've embraced the prior [op] process. So any specificity around expanding that, it's certainly something that we would always consider, but don't see that as a strategy in the short term.

在擴大商業方面的准入方面，請記住，鑑於我們沒有回扣，我們沒有折扣，這就是我們採用先前的 [op] 流程的原因。因此，對於擴大此範圍的任何具體措施，我們當然會一直考慮，但不會將其視為短期策略。

Eric, got anything you'd add to that?

艾瑞克，你還有什麼要補充嗎？

I would just say, I mean, to your point, following on from the prior authorization standpoint, the PA approval rate is very high. And I think you can see that with the uptake that we had in 2024 and certainly reflects the innovation and really the real value that it provides to patients.

我只想說，我的意思是，就你的觀點而言，從事先授權的角度來看，PA 批准率非常高。我認為您可以看到我們在 2024 年的採用，這無疑反映了創新以及它真正為患者提供的價值。

Ryan Deschner, Raymondja.

瑞安‧德施納、雷蒙德‧賈。

I wanted to ask about, what the level of promotion sensitivity for XPHOZAH looks like compared to what you're seeing at IBSRELA at this point in the launch? And then, I have a follow up.

我想問一下，與 IBSRELA 在發布階段相比，XPHOZAH 的促銷敏感度等級如何？然後，我有一個後續行動。

Sure. Yeah, right now, I would say the team is very focused. We've not expanded the team. We feel like we've got the right number, still continue to focus on the same targets that we did in 2024 and continuing to get receptivity.

當然。是的，現在我想說的是團隊非常專注。我們還沒有擴大團隊。我們覺得我們得到了正確的數字，仍然繼續關注我們在 2024 年所做的相同目標並繼續獲得接受度。

As Mike mentioned, obviously a lot of activity in the market and so the team continues to be focused on working with nephrologists, obviously working with the dialysis organizations as well. And right now from a promotional sensitivity standpoint, we feel like it's just as it was in 2024, and we still have the same confidence that we had coming into the year.

正如麥克所提到的，顯然市場上有很多活動，因此團隊繼續專注於與腎臟病專家合作，顯然也與透析組織合作。現在，從促銷敏感性的角度來看，我們感覺它與 2024 年一樣，我們仍然對今年抱有同樣的信心。

And then how are you thinking about expectations for gross to net further down the line of steady state for XPHOZAH now that you're 4 full quarters into the launch?

那麼，現在 XPHOZAH 的發布已經進行了整整 4 個季度，您如何看待其毛利率與淨利率在達到穩定狀態後的預期？

It's still relatively early, as you might imagine, the launch and with the payer dynamic change that we're seeing in 2025 and expect to see prospectively be truly to give precision. We try to give information when we have it. So as I said in my prepared remarks, we expect it to be less favorable in 2025 compared to 2024 because of the Medicaid and commercial related discounts, if you will, are higher than Medicare, but we'll give more color as things progress. It's just too early for us to give guidance.

正如您可能想像的那樣，現在還為時過早，我們將在 2025 年看到該技術的推出以及付款人的動態變化，並且預計未來將真正實現精確度。一旦獲得信息，我們就會盡力提供。因此，正如我在準備好的發言中所說的那樣，我們預計 2025 年的情況將不如 2024 年那麼有利，因為醫療補助和商業相關的折扣高於醫療保險，但隨著事態的發展，我們會提供更多細節。現在我們給出指導還為時過早。

Ed Arce, H.C. Wainright.

埃德阿爾塞，H.C.溫賴特。

This is Thomas here asking a couple of questions for Ed.

這是湯瑪斯，我向艾德問了幾個問題。

So first question, also an XPHOZAH, I just wonder if we can discuss the estimated, bottom line impact of XPHOZAH now being filled by transitional fantasy as well as the (inaudible) patient assistance program. Perhaps as a worst percentage of net sales, and also will this be reflected and cost of sales and starting in the first quarter?

所以第一個問題，也是 XPHOZAH，我只是想知道我們是否可以討論一下 XPHOZAH 現在被過渡幻想以及（聽不清楚）患者援助計劃所填充的估計底線影響。也許是淨銷售額中最差的百分比，這是否會反映在第一季的銷售成本中？

Yeah, so I just -- I believe I understand your question. Transition pharmacy is the Ardelyx Assist pharmacy. We have a closed distribution network with XPHOZAH as compared to IBSRELA, so there's no change that is different with transition being the pharmacy with whom we work. So I wouldn't expect a change in that. I know, Justin, you can address that as well.

是的，所以我只是——我相信我明白你的問題。過渡藥房是 Ardelyx Assist 藥房。與 IBSRELA 相比，我們與 XPHOZAH 擁有封閉的分銷網絡，因此與我們合作的藥房過渡沒有什麼不同。所以我並不期望這一點會改變。我知道，賈斯汀，你也可以解決這個問題。

But as Justin just said in the previous question, we do anticipate some change to gross to net due to the change in patient mix, which would be different that you will see going forward and we'll give you more clarity as things evolve.

但正如賈斯汀在上一個問題中所說的那樣，由於患者結構的變化，我們確實預計毛收入和淨收入會有一些變化，這將與您未來看到的情況有所不同，我們會隨著事態的發展為您提供更清晰的說明。

Just to reiterate what both Mike and Eric said earlier that our patient mix was approximately 60% Medicare, 40% non-Medicare in 2024. And so, that is, again, with patients losing Medicare Part D benefit coverage in 2025, that will be a change that we are working through in 2025 but still believe there's a significant population that we will build from.

只是想重申 Mike 和 Eric 之前所說的話，到 2024 年，我們的病患結構大約是 60％ 醫療保險，40％ 非醫療保險。因此，也就是說，由於患者在 2025 年將失去 Medicare Part D 福利保障，這將是我們正在努力在 2025 年實現的一項變革，但我們仍然相信，我們將從大量人口中實現這一變革。

And then on the, I believe you may be referring to the cost of our patient assistance program. So as a reminder, costs related to our patient assistance program do not run through cost of goods sold but rather are part of our SG&A expenditures. And again, they're somewhat modest, and that's been included in the guidance that we gave where we believe SG&A will increase approximately $10 million per quarter over the course of '25 compared to Q4 of 2024.

然後，我相信您可能指的是我們的患者援助計劃的成本。因此需要提醒的是，與我們的病患援助計畫相關的成本不計入銷售成本，而是屬於銷售、一般和行政費用 (SG&A) 支出的一部分。再次重申，這些數字還是比較溫和的，這已經包含在我們給出的指導中，我們認為與 2024 年第四季相比，2025 年銷售、一般及行政費用每季將增加約 1000 萬美元。

And then perhaps one more question from us with IBSRELA. Based on your methods guidance, $240 million in 2025 and you outline a number of initiatives this year, what other programs, strategy do you have in place in order for well to reach towards the $1 billion net sales goal?

然後也許我們還有一個關於 IBSRELA 的問題。根據您的方法指導，到 2025 年將實現 2.4 億美元銷售額，並且您今年概述了多項舉措，您還制定了哪些其他計劃和策略，以便實現 10 億美元的淨銷售額目標？

Sure, I'll ask Eric to comment a little bit more. But he said in his prepared remarks, the omnichannel efforts that we have underway, patient communication that is going to expand a number of other initiatives like that part of the omnichannel efforts.

當然，我會請 Eric 再多發表一些評論。但他在準備好的發言中表示，我們正在進行的全通路努力、病患溝通將擴大一系列其他舉措，就像全通路努力的這一部分一樣。

Yeah, I would -- as we come into 2025, we've got the continued expansion of the salesforce, so we've got a full team in place there. The team, the marketing team has done a great job. We've had the evolution of the campaign in Q4 of last year and continue to expand our patient initiatives and our patient marketing efforts.

是的，隨著我們進入 2025 年，我們的銷售團隊將繼續擴大，因此我們已經擁有一支完整的團隊。這個團隊、行銷團隊做得非常出色。我們在去年第四季度對活動進行了改進，並繼續擴大我們的患者計劃和患者行銷力度。

This is a devastating disease for these patients, and we need to continue to amplify the impact of the disease and the patient voice. We know we've got an engaged patient population, and we want to meet them where they are to make sure that they feel empowered and confident when they run or when they get into the office, and the marketing team is working very hard to really pull that through in 2025.

對於這些患者來說，這是一種毀滅性的疾病，我們需要繼續擴大這種疾病的影響和患者的聲音。我們知道我們擁有一群積極參與的患者，我們希望在他們所在的地方與他們見面，以確保他們在跑步時或進入辦公室時感到有力量和自信，行銷團隊正在努力在 2025 年真正實現這一目標。

And then from an access standpoint, we talked a bit about the field access managers. So again, as you think about that patient journey really from coming into the physician's office, talking about their disease and the impact on their life, and really raising their voice and being impactful with the physician to be able to get the right treatment for them. We feel that we've got the right insights, and we've got the right strategy that we're going to be able to amplify that in 2025. And then again, with the field access manager team to really help those patients be able to pull through so that they can continue to have access to IBSRELA.

然後從訪問的角度，我們討論了一下現場訪問管理器。所以，再說一次，當您真正思考病人的整個旅程時，從走進醫生辦公室，談論他們的疾病及其對他們生活的影響，並真正提高他們的聲音並與醫生產生影響，以便為他們提供正確的治療。我們認為我們已經獲得了正確的見解，並且制定了正確的策略，我們將能夠在 2025 年進一步擴大這一範圍。然後再次與現場訪問經理團隊合作，真正幫助那些患者渡過難關，以便他們可以繼續使用 IBSRELA。

Chris Raymond, Piper Sandler.

克里斯雷蒙德、派珀桑德勒。

Just on the commercial pay market for XPHOZAH, I know it's early, but as you guys have done scenario planning with such a large segment of the market getting free drug going forward, have you thought about when you might start to see private payers coming back to you for more discounts, if at all?

僅就 XPHOZAH 的商業付費市場而言，我知道現在還為時過早，但既然你們已經為未來如此大的市場份額獲得免費藥物做好了情景規劃，那麼你們有沒有想過什麼時候你們會開始看到私人付款人回來向你們索取更多折扣，如果有的話？

Ask maybe another way. I know XPHOZAH already has a decent discount off of the list price, but is there a point in time where maybe you'll feel comfortable that you won't see any more significant pricing pressure from the commercial market?

也許可以用其他方法詢問。我知道 XPHOZAH 已經對標價進行了相當大的折扣，但是否會有那麼一個時候，您會感到放心，不會再看到來自商業市場的更大價格壓力？

We actually don't discount to payers. That's the whole decision that we made to embrace the prior authorization process. And you know, if and when they come to us, that means that we have come to their radar and generating sufficient revenue that we're, they're going to ask us those questions when or even if that happens, I think it's hard to predict. Eric, any thoughts?

我們實際上並未向付款人提供折扣。這就是我們所做的採用事先授權流程的全部決定。你知道，如果他們來找我們，那就意味著我們進入了他們的視線，並且產生了足夠的收入，他們會問我們這些問題，即使這種情況發生了，我也認為很難預測。艾瑞克，有什麼想法嗎？

Yeah, I would say our primary objective is access to XPHOZAH. And in the current market, patients can have access, we're seeing that, certainly on the commercial side and the other non-Medicare segments. Should that change and should we start to engage in communications, again, our primary goal is access to XPHOZAH, and we will engage in those conversations. And if we need to shift and pivot, then we certainly have the flexibility to do so. But right now, we continue to see that the access is maintained in those non-Medicare segments, and we're going to continue to push forward.

是的，我想說我們的主要目標是造訪 XPHOZAH。在當前市場中，我們看到患者可以獲得服務，當然在商業方面和其他非醫療保險領域。如果情況發生變化並且我們開始進行溝通，那麼我們的主要目標是訪問 XPHOZAH，我們將參與這些對話。如果我們需要轉變和調整，那麼我們當然可以靈活地這樣做。但目前，我們持續看到非醫療保險領域的服務仍得以維持，我們將繼續前進。

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。我想將會議交還給總裁兼執行長 Mike Raab)，請他作最後發言。

Thank you all for joining us this morning. A special shoutout goes to (inaudible), who I know is listening. Your hard work is invaluable in bringing our essential medicines to patients, and we wouldn't be where we are without you. I also want to acknowledge our shareholders for their support on this journey.

感謝大家今天早上參加我們的活動。特別感謝（聽不清楚），我知道他正在聽。你們的辛勤工作對於我們為患者提供基本藥物具有無價的價值，沒有你們，我們就不會取得今天的成就。我還要感謝我們的股東在這一歷程中給予的支持。

We're building a significant company, having successfully developed our medicines from initial concept through development and now, into commercialization. This achievement is not just noteworthy, it's a testament to our capabilities, and we're excited to seize the opportunity and to do it again.

我們正在建立一家重要的公司，成功地開發了我們的藥物，從最初的概念到開發，再到現在的商業化。這項成就不僅值得注意，也證明了我們的能力，我們很高興抓住機會再次做到這一點。

With that, we can conclude the call. Thank you, operator.

至此，我們就可以結束通話了。謝謝您，接線生。

This concludes today's conference call. Thank you for attending.

今天的電話會議到此結束。感謝您的參加。