Ardelyx Inc (ARDX) 2025 Q3 法說會逐字稿

Good day, everyone, and welcome to the Ardelyx third-quarter 2025 earnings conference call. (Operator Instructions) Now I'd like to turn the call over to Caitlin Lowie, Vice President of Corporate Communications and Investor relations. Caitlin, please go ahead

大家好，歡迎參加 Ardelyx 2025 年第三季財報電話會議。（操作員指示）現在，我想把電話交給企業傳播和投資者關係副總裁凱特琳·洛維。凱特琳，請繼續。

Thank you. Good afternoon and welcome to our third-quarter 2025 financial results call. During this call, we were referred 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2025年第三季財務業績電話會議。在這次通話中，我們被告知今天早些時候發布的新聞稿，該新聞稿可在公司網站 ardelyx.com 的投資者關係部分找到。

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 that will be filed today and can be found on our website at our 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，我們將發表一些前瞻性聲明，這些聲明存在風險和不確定性。我們的實際結果可能與所述結果有顯著差異。我們建議您查閱我們今天將提交的最新季度報告（10-Q 表格），該報告可在我們的網站 ardelyx.com 上找到。儘管我們未來可能會更新這些前瞻性聲明，但我們明確聲明不承擔任何更新義務，即使我們的觀點發生變化。

Our President and CEO, Mike Raab, will begin today’s call with opening remarks and an overview of the company’s progress during Q3 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 Q3 ended September 30, 2025, before we open the call to questions.

我們的總裁兼執行長麥克拉布將在今天的電話會議上致開幕詞，並概述公司在 2025 年第三季的進展。接下來，首席商務官埃里克·福斯特將介紹 IBSRELA 和 XPHOZAH 的業績最新情況。財務與營運長賈斯汀·倫茨將在今天的準備好的演講中回顧公司截至 2025 年 9 月 30 日的第三季財務業績，之後我們將開放提問環節。

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

那麼，我把電話交給麥克吧。

Thanks, Caitlin. It’s great to be here with all of you today to share our Q3 2025 results, another standout quarter for both IBSRELA and XPHOZAH. This performance demonstrates the power of our commercial model, the momentum behind our products, the exceptional execution by our team, and the real-world impact that our differentiated therapies are having for both patients with IBS-C and for those with CKD on dialysis.

謝謝你，凱特琳。今天很高興能和大家一起分享我們 2025 年第三季的業績，對於 IBSRELA 和 XPHOZAH 來說，這又是一個出色的季度。這項業績證明了我們商業模式的強大實力、我們產品的強勁勢頭、我們團隊的卓越執行力，以及我們差異化療法對 IBS-C 患者和接受透析治療的 CKD 患者產生的實際影響。

We generated $105.5 million in product revenue during Q3, representing 15% YoY growth, a signal of strong demand across our portfolio. In January, I outlined four key priorities for Ardelyx this year: one, to accelerate IBSRELA’s momentum; two, to execute on our XPHOZAH strategy; three, to build a pipeline; and four, to continue delivering strong financial performance.

第三季度，我們的產品收入達到 1.055 億美元，年增 15%，這表明我們的產品組合需求強勁。今年一月，我為 Ardelyx 概述了四個關鍵優先事項：一、加快 IBSRELA 的發展勢頭；二、執行我們的 XPHOZAH 戰略；三、建立產品線；四、繼續取得強勁的財務業績。

Ten months later, it is clear that the team at Ardelyx is delivering on these key priorities, and as a result, we’re building real, sustainable momentum. I’d like to provide a bit more detail on each of these areas. IBSRELA continues to outperform and is the foundation of our portfolio and the main engine for Ardelyx’s future growth. IBSRELA set yet another record, generating $78.2 million during Q3, a 92% increase over last year.

十個月後，很明顯，Ardelyx 團隊正在實現這些關鍵優先事項，因此，我們正在建立真正的、可持續的發展勢頭。我想就這些方面提供更詳細的說明。IBSRELA 持續表現優異，是我們投資組合的基礎，也是 Ardelyx 未來成長的主要引擎。IBSRELA 再創佳績，第三季營收達 7,820 萬美元，比去年同期成長 92%。

Demand growth is broad-based and demonstrates how vital this therapy is for patients. The IBSRELA team is doing an exceptional job expanding reach and deepening prescriber engagement and conviction. Every driver that has fueled our success remains strong: a passionate patient community, an engaged prescriber base, and a novel commercial strategy.

需求成長基礎廣泛，這表明這種療法對患者至關重要。IBSRELA 團隊在擴大覆蓋範圍、加深處方醫生的參與和信念方面做得非常出色。推動我們成功的每一個因素仍然強勁：充滿熱情的患者群體、積極參與的處方醫生群體以及創新的商業策略。

We expect this momentum to continue through Q4 and beyond, and as a result, we are raising our guidance, and we expect to generate between $270 million and $275 million in IBSRELA revenue this year. XPHOZAH also had an incredibly strong quarter, generating $27.4 million in revenue, a 9% increase compared to Q2.

我們預計這一勢頭將持續到第四季度及以後，因此，我們提高了業績預期，預計今年 IBSRELA 的收入將在 2.7 億美元至 2.75 億美元之間。XPHOZAH 的本季業績也非常強勁，營收達到 2,740 萬美元，比第二季成長了 9%。

The XPHOZAH team is navigating this dynamic market with determination and agility as we execute on our strategy, ensuring patient access, strengthening clinical conviction among nephrologists, and driving prescription pull-through. XPHOZAH is a valuable component of our growth, and we expect its contribution to our business will only grow over time. Today’s announcement of RDX 10531, which we will refer to as 531, is the next-generation NHE3 inhibitor and marks an important milestone for Ardelyx as we reinvigorate our pipeline.

XPHOZAH 團隊正以堅定的決心和敏捷的行動來應對這個充滿活力的市場，執行我們的策略，確保患者獲得治療，增強腎臟科醫生的臨床信心，並推動處方推廣。XPHOZAH 是我們發展的重要組成部分，我們預期它對我們業務的貢獻只會隨著時間的推移而不斷增長。今天宣布的 RDX 10531（我們將稱之為 531）是下一代 NHE3 抑制劑，標誌著 Ardelyx 在重振產品線方面邁出了重要一步。

We at Ardelyx pioneered NHE3 inhibition, and with tenapanor, we have the only approved modulator of this pathway on the market. With 531, we may be able to unlock even greater benefit for patients. Early preclinical data demonstrates that 531 is a highly potent, highly soluble molecule that could open development opportunities across a broad range of therapeutic areas. Preclinical and manufacturing activities are underway in advance of a Phase I study.

Ardelyx 公司率先研發了 NHE3 抑制劑，而 tenapanor 是目前市場上唯一核准的該通路調節劑。有了 531，我們或許能為患者帶來更大的益處。早期臨床前數據表明，531 是一種高效、高溶解度的分子，可能在廣泛的治療領域開闢開發機會。臨床前研究和生產活動正在進行中，為 I 期研究做準備。

This investment in 531 reflects thoughtful stewardship of an important internal asset and is our first new development program in more than three years. We are committed to building a broad, sustainable pipeline, capitalizing first on an internal asset while, in parallel, we explore external opportunities. As we build this pipeline, we are taking a disciplined and forward-thinking approach, identifying opportunities where Ardelyx can win.

對 531 號大樓的這項投資體現了我們對一項重要內部資產的深思熟慮的管理，也是我們三年多來的第一個新開發項目。我們致力於建構廣泛、永續的研發管線，首先充分利用內部資源，同時探索外部機會。在建構這條產品線的過程中，我們採取了嚴謹且具有前瞻性的方法，尋找 Ardelyx 可以取得成功的機會。

We are going to leverage our expertise, assets, and scientific, clinical, and commercial leadership to unlock value. 531 is a reflection of that approach, and I look forward to sharing more information on our plans for this molecule as we advance through the development program. Finally, I want to highlight our financial strength.

我們將充分利用我們的專業知識、資源以及在科學、臨床和商業領域的領先地位來釋放價值。 531 正是這理念的體現，我期待隨著研發項目的推進，與大家分享更多關於該分子研發計畫的資訊。最後，我想強調一下我們的財務實力。

With the meaningful revenues we expect to generate in 2026 and beyond, we’re extremely well-positioned to thoughtfully invest our capital in current commercial endeavors and to grow our pipeline. We are delivering our four key priorities. We are driving meaningful impact for patients, and we are creating lasting value for shareholders. Before I hand the call over to Eric, I’d like to formally welcome Suhong Leitner to Ardelyx as our Chief Financial Officer.

憑藉我們預計在 2026 年及以後將產生的可觀收入，我們完全有能力將資金謹慎地投資於當前的商業活動，並拓展我們的產品線。我們正在推進四大重點優先事項。我們正在為患者帶來有意義的影響，並為股東創造持久的價值。在將電話交給 Eric 之前，我想正式歡迎 Suhong Leitner 加入 Ardelyx 擔任財務長。

She’s a remarkable leader who brings deep financial and strategic expertise to Ardelyx, and she’s already making her mark, challenging our thinking, strengthening our plans, and energizing our path forward. She’s joining a highly experienced leadership team with the technical expertise, vision, and enthusiasm to lead and write the next chapter for Ardelyx. With that, I’m pleased to turn the call over to Eric, who will share his perspectives on our commercial performance. Eric.

她是一位傑出的領導者，為 Ardelyx 帶來了深厚的財務和戰略專業知識，她已經嶄露頭角，挑戰著我們的思維，強化著我們的計劃，並為我們前進的道路注入了活力。她將加入一支經驗豐富的領導團隊，該團隊擁有技術專長、遠見卓識和滿腔熱情，能夠帶領 Ardelyx 開啟新的篇章。接下來，我很高興將電話交給艾瑞克，他將分享他對我們商業表現的看法。埃里克。

Thanks, Mike, and it’s great to be with you all once again. The commercial organization continues to operate at an exceptionally high level. Our commercial strategy is strong and continues to be the foundation of our success. We are focused on addressing areas of high unmet need, delivering first-in-class medicines, leveraging a targeted sales and marketing approach to both patients and prescribers, and investing in high-impact patient services programs to improve access. I’m excited to share with you today how this focus drove our performance during Q3. Starting with IBSRELA, the strong demand for IBSRELA continued during Q3, leading to our highest demand quarter since launch. Additionally, we delivered record highs in the following areas. Revenue was $78.2 million, posting 92% growth year-over-year.

謝謝你，麥克，很高興再次和大家聚在一起。該商業機構繼續保持極高的營運水準。我們的商業策略非常穩健，並且一直是公司成功的基石。我們專注於解決未被滿足的重大需求領域，提供一流的藥物，利用有針對性的銷售和行銷方法面向患者和處方醫生，並投資於具有重大影響的患者服務項目以改善醫療服務可及性。今天我很高興與大家分享這項重點是如何推動我們在第三季取得優異成績的。從 IBSRELA 開始，第三季對 IBSRELA 的強勁需求持續下去，使我們迎來了自上市以來需求最高的季度。此外，我們在以下領域也取得了歷史新高。營收達7,820萬美元，年增92%。

We continued to see the strength of our field sales force and the impact of our marketing initiatives, which drove us to new highs in new writers and total writers, reflecting growth in both depth and breadth of writing. This increase in writers also led to growth in new, refill, and total prescriptions. Once again, the increased and focused activity from our field access manager team resulted in improved pull-through rates.

我們繼續看到現場銷售團隊的實力和行銷舉措的影響，這推動我們在新作家和作家總數方面都達到了新高，反映出寫作的深度和廣度都在增長。處方藥使用者的增加也導致了新處方、續方和處方總量的成長。我們的現場准入管理團隊加強了工作力度，更加重視實效，再次提高了成交率。

These results clearly indicate that our strategies are working, and our strong momentum continues. We remain focused on the patient, the prescriber, and improving prescription pull-through so more patients can benefit from IBSRELA. First, the patient. IBS-C patients are incredibly engaged and consistently seek information and new options to address their unmet IBS-C symptoms. In fact, more than 75% of surveyed patients report that they continue to experience the symptoms of IBS-C despite treatment on a secretagogue.

這些結果清楚地表明，我們的策略是有效的，而且我們強勁的發展勢頭仍在繼續。我們始終關注患者、處方醫生以及提高處方轉換率，以便更多患者能夠從 IBSRELA 中受益。首先是病人。IBS-C 患者非常積極主動，不斷尋求資訊和新的解決方案來解決他們尚未滿足的 IBS-C 症狀。事實上，超過 75% 的受訪患者表示，儘管接受了促分泌劑治療，他們仍然會經歷 IBS-C 的症狀。

In contrast, patients report highly satisfied with IBSRELA. In a poster we presented earlier this week at the American College of Gastroenterology’s annual scientific meeting, 88% of surveyed IBSRELA patients reported treatment satisfaction. Further internal market research also suggests that when patients learn about IBSRELA, they are motivated to ask for the therapy by name; and when they do, physicians are highly likely to prescribe it. Our focus on the patient will continue, and in some areas, we will increase our investment in targeted patient marketing efforts to support our future growth expectations.

相較之下，患者對 IBSRELA 的滿意度很高。在本週稍早我們在美國胃腸病學會年度科學會議上展示的一張海報中，88% 的受訪 IBSRELA 患者表示對治療感到滿意。進一步的內部市場調查也表明，當患者了解 IBSRELA 時，他們會主動要求接受這種療法；而當他們這樣做時，醫生很可能會開這種藥。我們將繼續以患者為中心，並在某些領域加大對有針對性的患者行銷工作的投入，以支持我們未來的成長預期。

Next is the prescribing healthcare provider. The investments we have made in our field-based team and physician marketing efforts continue to demonstrate that HCPs are highly responsive to IBSRELA’s safety, efficacy, and tolerability profile and its differentiated mechanism of action. Once again, we saw increased targeted activity from our sales team, who drove expanded adoption and utilization.

接下來是開處方的醫療保健提供者。我們在現場團隊和醫生行銷工作方面的投入不斷證明，醫療保健專業人員對 IBSRELA 的安全性、有效性和耐受性以及其差異化的作用機制反應非常積極。我們的銷售團隊再次加大了針對性活動，推動了產品的廣泛採用和使用。

We maintain our focus on driving depth and breadth of prescribing among high-writing HCPs who are frequently seeing patients with IBS-C. Our messages are resonating, and the team will continue to drive clinical conviction and ultimately to identify and prescribe IBSRELA for those in need. Finally, prescription pull-through. The investments we are making in this area are delivering improvements across the patient journey.

我們將繼續致力於提高經常接診 IBS-C 患者的高處方量 HCP 的處方深度和廣度。我們的訊息引起了共鳴，團隊將繼續推進臨床實踐，最終為有需要的人識別並開立 IBSRELA 處方。最後，處方提取。我們在該領域的投資正在改善患者的就醫體驗。

Our field access manager team increased their call activity during Q3, translating into increased rates of prior authorization approvals and resubmission approvals. We continue to look for ways to improve the patient experience, lessen the burden on HCPs, and help ensure that every patient who is prescribed IBSRELA gets on treatment. We are focused on addressing critical aspects of the patient and physician journey and maintaining and building momentum as we enter Q4.

我們的現場准入管理團隊在第三季增加了電話活動，從而提高了事先授權批准率和重新提交批准率。我們將繼續尋找改善病患體驗、減輕醫護人員負擔的方法，並協助確保每位被處方 IBSRELA 的病患都能接受治療。我們專注於解決患者和醫生就醫過程中的關鍵問題，並在進入第四季度之際保持和增強發展勢頭。

As I mentioned earlier, my team and I just attended the ACG annual conference, and we heard directly from many HCPs about the impact of IBS-C and the important role that IBSRELA is playing for their patients. We are committed to the patient community, and we continue to bring important science to HCPs with three posters presented at the conference. I’m incredibly proud of all this team has accomplished, and I look forward to a strong close to 2025 on our path to more than $1 billion peak revenue.

正如我之前提到的，我和我的團隊剛剛參加了 ACG 年會，我們直接聽取了許多 HCP 的發言，了解了 IBS-C 的影響以及 IBSRELA 對他們的患者所發揮的重要作用。我們致力於服務患者群體，並繼續透過在會議上展示的三張海報，為醫療保健專業人員帶來重要的科學成果。我為團隊所取得的所有成就感到無比自豪，並期待在 2025 年實現超過 10 億美元的高峰收入目標。

Now turning to XPHOZAH. The team continues to execute and drive demand. In Q3, the team delivered $27.4 million in revenue, a solid 9% revenue growth compared to Q2. This demand-driven growth demonstrates a clear need among patients for XPHOZAH. Our strategy is anchored in access to XPHOZAH for all patients who receive a prescription, regardless of payer.

現在轉向 XPHOZAH。團隊持續執行並推動需求。第三季度，該團隊實現了 2,740 萬美元的收入，與第二季度相比實現了 9% 的穩健成長。這種需求驅動的成長顯示患者對 XPHOZAH 有明顯的需求。我們的策略是讓所有獲得處方的患者都能獲得 XPHOZAH，無論付款者是誰。

We are pleased that this strategy is working, and we remain confident in our long-term growth expectations. The team remains focused on driving clinical conviction among nephrologists to prescribe XPHOZAH for appropriate patients, encouraging prescriptions to be sent to Ardelyx Assist to ensure patients get on treatment, and providing important resources to support prescription pull-through. Our steady and consistent progress is evident in the growth we see across a number of key demand indicators.

我們很高興看到這項策略奏效，並且我們對長期成長預期仍然充滿信心。該團隊仍然致力於增強腎臟科醫生對 XPHOZAH 的臨床信心，鼓勵將處方發送到 Ardelyx Assist，以確保患者接受治療，並提供重要資源來支持處方的順利執行。從多項關鍵需求指標的成長可以看出，我們取得了穩定持續的進步。

Total writers grew quarter over quarter. We grew new and refilled prescriptions, which resulted in growth in total dispenses compared to Q2, including increased volume for both paid and patient-assisted prescriptions. In short, more patients have access to XPHOZAH today than ever before. We also saw continued improvement in prescription pull-through following our investment in the field access manager team. Importantly, we saw a second consecutive quarter of growth in the non-Medicare payer segments.

作者總數較上季成長。我們新增和續開的處方數量增加，與第二季度相比，總配藥量有所增長，包括付費處方和患者自費處方的數量均有所增加。簡而言之，如今比以往任何時候都有更多的患者能夠獲得 XPHOZAH 治療。我們對現場准入管理團隊進行投資後，處方取得率也持續提高。值得注意的是，非醫療保險支付方領域連續第二季實現了成長。

These are all very encouraging indicators, demonstrating that the momentum we experienced in Q2 continues through Q3 as a result of our strong commercial execution. We focused on expanding breadth and depth of XPHOZAH writing among healthcare providers and continue to place the nephrologist at the center of decision-making. We also connect with other stakeholders in the community, including the dialysis providers, renal dieticians, and advocacy organizations that are important to patient care.

這些都是非常令人鼓舞的指標，顯示由於我們強大的商業執行力，我們在第二季取得的動能在第三季得以延續。我們致力於擴大 XPHOZAH 在醫療保健提供者中的寫作廣度和深度，並繼續將腎臟科醫生置於決策的核心地位。我們也與社區中的其他利益相關者保持聯繫，包括透析服務提供者、腎臟營養師和對患者護理至關重要的倡導組織。

We have a broad-based team focused across the patient journey and continue to engage with all stakeholders about the importance of XPHOZAH. I will be joining the team on Tuesday at the American Society of Nephrology’s Kidney Week to engage directly with HCPs and learn from them about the value that XPHOZAH provides.

我們擁有一支涵蓋病患就醫全程的廣泛團隊，並持續與所有利害關係人溝通，強調 XPHOZAH 的重要性。我將於週二加入團隊，參加美國腎臟病學會的腎臟週活動，直接與醫療保健專業人員交流，並向他們了解 XPHOZAH 提供的價值。

We also have three posters being presented that will further support our efforts and will highlight the importance of XPHOZAH for patients with elevated phosphorus. Consistent progress will fuel a strong finish to 2025 for XPHOZAH and create a solid foundation for further growth next year and beyond. I am proud of this team and their efforts in this dynamic market. We remain confident in our long-term peak guidance of $750 million.

我們還有三張海報將進行展示，這將進一步支持我們的工作，並強調 XPHOZAH 對高磷患者的重要性。持續進步將推動 XPHOZAH 在 2025 年取得強勁的收官，並為明年及以後的進一步發展奠定堅實的基礎。我為這支團隊及其在這個充滿活力的市場中所付出的努力感到自豪。我們仍然對7.5億美元的長期高峰預期充滿信心。

Looking at Q4 and into next year across our portfolio of products, we will continue to execute our strategies at a high level and create new opportunities for growth. We have the right team and the right focus. We’re making a difference for patients and driving impact across the business, and we remain steadfast in our commitment to bring these important medicines to the many patients in need.

展望第四季及明年，我們將繼續高水準地執行我們的產品組合策略，並創造新的成長機會。我們擁有合適的團隊和正確的方向。我們正在為患者帶來改變，並推動整個業務的發展，我們將堅定不移地致力於為眾多需要這些重要藥物的患者提供服務。

I will now turn it over to Justin. Justin?

現在我會把任務交給賈斯汀。賈斯汀？

Thanks, Eric. Ardelyx delivered an impressive quarter with continued meaningful growth for both products and another record-setting quarter for IBSRELA. We thoughtfully invested to improve our commercial opportunities, restarted our pipeline, and strengthened our balance sheet through significant top-line growth. Starting with revenue.

謝謝你，埃里克。Ardelyx 的季度業績令人矚目，兩款產品均持續實現顯著成長，IBSRELA 也再次創下季度紀錄。我們進行了深思熟慮的投資，以改善我們的商業機會，重啟了我們的產品線，並透過顯著的營收成長增強了我們的資產負債表。首先從營收說起。

For the period ended September 30, 2025, we reported total revenue of $110.3 million, an increase of 12% compared to the $98.2 million we reported in Q3 of last year. The growth was primarily driven by an incredibly strong performance by IBSRELA, recording revenue of $78.2 million, an increase of 92% over the same period last year. The team’s focus on driving increased demand for IBSRELA and improving prescription pull-through continues to drive this momentum. The performance was also the result of expected improvement in our gross-to-net deduction, finishing the Q3 at approximately 31%, a slight improvement over Q2.

截至 2025 年 9 月 30 日止期間，我們報告的總營收為 1.103 億美元，比去年第三季報告的 9,820 萬美元成長了 12%。此次成長主要得益於 IBSRELA 的強勁表​​現，其營收達到 7,820 萬美元，比去年同期成長了 92%。該團隊專注於推動對 IBSRELA 的需求增加和提高處方轉換率，這繼續推動著這一勢頭。這項業績也得益於毛利與淨利扣除額的預期改善，第三季結束時比率約為 31%，比第二季略有改善。

We expect IBSRELA growth to continue, and as such, we are raising our guidance and currently expect to finish the year between $270 and $275 million in revenue. XPHOZAH delivered another solid quarter of growth, generating $27.4 million in revenue during the Q3 of 2025, an increase of 9% compared to the second quarter of this year. Our gross-to-net deduction of approximately 29% was consistent with the second quarter.

我們預計 IBSRELA 的成長將持續，因此，我們提高了預期，目前預計今年的營收將在 2.7 億美元至 2.75 億美元之間。XPHOZAH 又實現了穩健的季度成長，在 2025 年第三季創造了 2,740 萬美元的收入，比今年第二季成長了 9%。我們的毛利與淨利潤之比約為 29%，與第二季的情況一致。

Finally, you will note that we recorded $4.8 million in non-cash royalty and commercial milestone revenue during the quarter, a significant increase compared to previous quarters and last year. We are pleased to share that our partner in Japan, Kyowa Kirin, achieved year-to-date sales levels that triggered a $3.4 million payment, which we passed along to healthcare royalty partners later this quarter. Now turning to expenses.

最後，您會注意到，本季我們錄得 480 萬美元的非現金特許權使用費和商業里程碑收入，與前幾季和去年相比，這是一個顯著的成長。我們很高興地宣布，我們在日本的合作夥伴協和麒麟今年迄今為止的銷售額達到了觸發 340 萬美元付款的水平，我們將在本季度晚些時候將這筆款項轉交給醫療保健特許權使用費合作夥伴。現在來說說費用。

Q3 expenditures were up compared to the same period of 2024, reflecting our investment in growth, and spending levels were consistent with Q2 of this year. R&D expenses were $18.1 million for the Q3 of 2025 compared to $15.3 million for the same quarter of the prior year. SG&A expenses were in line with our expectation at $83.6 million compared to $65 million we reported in the Q3 of last year and reflects our continued investments in commercial activities to drive growth.

第三季支出較 2024 年同期增加，反映了我們對成長的投資，支出水準與今年第二季持平。2025 年第三季研發費用為 1,810 萬美元，去年同期為 1,530 萬美元。銷售、一般及行政費用符合我們的預期，為 8,360 萬美元，而去年第三季我們報告的為 6,500 萬美元，這反映了我們為推動成長而持續投資於商業活動。

Our net loss was approximately $1 million, or less than a penny per share in the Q3, compared to a net loss of approximately $800,000 in the same period of last year. In addition, our Q3 2025 results included $4.8 million in non-cash revenue, $12.7 million in non-cash stock compensation expense, and $2.2 million in non-cash interest expense.

第三季度，我們的淨虧損約為 100 萬美元，即每股虧損不到 1 美分，而去年同期淨虧損約 80 萬美元。此外，我們 2025 年第三季的業績包括 480 萬美元的非現金收入、1,270 萬美元的非現金股票補償支出和 220 萬美元的非現金利息支出。

We are pleased to report positive Q3 cash flow as a result of significant growth on the top line. We finished the quarter with a very strong balance sheet, including $242.7 million of cash, cash equivalents, and short-term investments. As I prepare to step away from the CFO role at Ardelyx, I would like to thank all the investors and analysts who I’ve had the pleasure to interact with over these past five-plus years.

我們很高興地報告，由於營收大幅成長，第三季現金流為正。本季末，我們的資產負債表非常穩健，其中包括 2.427 億美元的現金、現金等價物和短期投資。在我即將卸任 Ardelyx 財務長一職之際，我想感謝過去五年多來我有幸與之交流的所有投資者和分析師。

I would also like to thank all of the Ardelyx team members who I’ve had the privilege to work with. I’m delighted to welcome Sue to the team. We’ve had the opportunity to work together in transitioning the various tasks over these past couple of weeks, and you will find her to be a strong and capable financial leader. I look forward to following Ardelyx in the future as I begin my next journey.

我還要感謝所有與我共事過的 Ardelyx 團隊成員。我很高興歡迎蘇加入團隊。在過去的幾周里，我們有機會一起合作完成各項任務的交接，你會發現她是一位能力出眾、幹練的財務領導者。我期待在未來的旅程中繼續關注 Ardelyx 的發展。

With that, I’ll hand it back to Mike.

說完，我就把它還給麥克。

Thank you, Justin. Not just for the thoughtful commentary that you provided as you finished out your final quarter with us, but for your leadership, your partnership, and support of everyone at Ardelyx. Ardelyx’s Q3 performance was a continuation of consistently delivering on our priorities. IBSRELA’s strength is the foundation of our growth, and the opportunities ahead for this business are significant.

謝謝你，賈斯汀。不僅感謝您在我們公司最後一個季度結束時提供的深思熟慮的評論，還要感謝您的領導、合作以及對 Ardelyx 所有員工的支持。Ardelyx 第三季的業績延續了我們一貫以來優先履行的職責。IBSRELA 的實力是我們發展的基礎，而該業務未來的發展機會十分巨大。

XPHOZAH remains an important contributor to our business. 531 is our re-entry to product development, and our strong cash position demonstrates our focus on being prudent stewards of our resources while investing in growth. I look forward to sharing more updates on our progress in the quarters ahead. Elvis, you can now open the call to questions.

XPHOZAH 仍然是我們業務的重要貢獻者。 531 標誌著我們重返產品研發領域，而我們強勁的現金流也反映了我們在投資成長的同時，注重審慎管理資源。我期待在接下來的幾季與大家分享我們取得的更多進展。艾維斯，現在可以開始接受提問了。

(Operator Instructions) Chris Raymond, Raymond James.

（操作說明）克里斯·雷蒙德，雷蒙德·詹姆斯。

Hey, thanks for taking the question. Best of luck to you, Justin. It was great working with you and hope to in the future. Just some questions. First of all, on IBSRELA. Looking at the, I guess it’s the SpherX data that kind of sticks out to me the most. You guys have now sort of mid-teens share, I think, overall, in the IBS-C market, but first-line share looks like it’s also in the single digits.

嘿，謝謝你回答這個問題。祝你好運，賈斯汀。和您一起工作非常愉快，希望將來還能有機會合作。我有幾個問題。首先，關於 IBSRELA。縱觀這些數據，我覺得最讓我印象深刻的是 SpherX 數據。我認為，你們目前在 IBS-C 市場總體上擁有大約 15% 的份額，但一線市場份額似乎也只有個位數。

Mike, maybe. Obviously, you got a long way to go to compete with LINZESS for front-line share, but maybe just talk about how front-line use is factoring into your long-range sort of plans and what you guys are doing to try to make that more of a lever that you can pull.

或許是麥克。顯然，你們要與 LINZESS 爭奪一線市場份額還有很長的路要走，但或許可以談談一線使用情況是如何納入你們的長期計劃的，以及你們正在採取哪些措施來使之成為你們可以利用的槓桿。

And then maybe the next question then on the 10531. I guess you guys didn’t talk about indications for a reason. But just looking at the literature and potential targets for a potent soluble molecule here. There’s some pretty big indications: hypertension, heart failure, maybe some diabetes indications. Are you looking at something as more broad or more of a targeted indication?

接下來或許是關於 10531 的下一個問題。我想你們不討論指標是有原因的。但僅從文獻來看，這裡存在著一種強效可溶性分子，其潛在標靶也值得關注。有一些相當嚴重的症狀：高血壓、心臟衰竭，可能還有一些糖尿病症狀。您是著眼於更廣泛的適應症，還是更具針對性的適應症？

I think let me answer the second part first. We’ve got to take some baby steps before we go to the sprint and marathon. I mean, we understand how to develop NHE3 inhibitors exceedingly well. The characteristics of the molecules are extremely unique. And the fact that we’ve got one that’s as soluble and potent as this does open up the opportunity to consider things like what you just described.

我想先回答第二個問題。在進行短跑和馬拉松之前，我們必須先踏出一些小步伐。我的意思是，我們非常了解如何開發 NHE3 抑制劑。這些分子的特性極為獨特。而我們擁有了這種溶解性好、效力強的物質，這確實為我們考慮你剛才所描述的情況提供了機會。

It is premature for us to consider what indications until we go through these initial steps. As I said in my comments, the ability that we now have to invest in what we have created in NHE3 inhibition is an incredible strength. I’ll head off questions that I’m sure are going to come that this is well within our ability to spend and get it to the phases of development as we take advantage of the engine that IBSRELA is.

在我們完成這些初步步驟之前，考慮哪些跡象還為時過早。正如我在評論中所說，我們現在有能力投資於我們在 NHE3 抑制方面所取得的成就，這是一項巨大的優勢。我會先回答一些肯定會出現的問題，那就是我們完全有能力投入資金，並利用 IBSRELA 引擎將其推進到開發階段。

To your questions about IBSRELA, I’ll ask Eric to comment on it as well. I think as we’ve spoken in the past, Chris, the indication in our clinical work was first line. There is nothing in our label, nothing in our clinical work that says it cannot be first line; and the growth that you see in that is completely organic.

關於您提出的 IBSRELA 問題，我也會請 Eric 對此發表評論。我認為正如我們之前討論過的，克里斯，在我們的臨床工作中，其適應症是作為一線治療。我們的標籤上沒有任何內容，我們的臨床工作中也沒有任何內容表明它不能作為一線藥物；而你看到的增長完全是自然而然的。

When we started this effort to commercialize IBSRELA, we made the intentional decision to position it in a way that is second and third line because no matter what we did with PBMs and formularies, we would never be first-line because we wouldn’t generate the kind of revenue to supplant what they’re getting from current first-line therapies. We are seeing that organic growth because it is a good drug, and experience with physicians who are writing the scripts are being successful in driving those through.

當我們開始將 IBSRELA 商業化時，我們有意決定將其定位為二線和三線藥物，因為無論我們如何與藥品福利管理機構 (PBM) 和藥品目錄合作，我們都永遠無法成為一線藥物，因為我們無法產生足夠的收入來取代他們目前從一線療法中獲得的收入。我們看到這種自然增長是因為這是一種好藥，而且開處方的醫生們的經驗也成功地推動了這些處方的銷售。

There are millions of patients on GCC agonists right now, 80% or more of which are dissatisfied with their therapy. The market could grow no more, and we would still be able to meet our objectives and the projections that we’ve had. I think it’s a really important way to think about the business. Because the way that we’ve approached this, our target and our commitment to a billion dollars or more is based upon second-line therapy with the established patients that are there and the call points that Eric and the team are pursuing. Anything to add to that, Eric?

目前有數百萬患者正在接受 GCC 激動劑治療，其中 80% 或以上的患者對他們的治療效果不滿意。即使市場不再成長，我們仍然能夠實現我們的目標和預期。我認為這是一種非常重要的商業思維。因為我們採取的方法，我們實現十億美元或以上的目標和承諾，是基於對現有患者的二線治療，以及埃里克和他的團隊正在努力實現的目標。艾瑞克，還有什麼要補充的嗎？

Thanks, Chris, for the question. Yeah, the only thing that I would add to that, Mike, is we’re coming off a Q3 where we’ve got all-time highs in new writers and total writers. Clearly, we are doing a great job of expanding breadth and depth and utilization of IBSRELA. With that comes confidence in the product when they see the results and the impact that it can have with patients.

謝謝克里斯的提問。是的，麥克，我唯一要補充的是，我們剛剛結束了第三季度，該季度新簽約作家和作家總數都創下了歷史新高。顯然，我們在擴大 IBSRELA 的廣度、深度和利用方面做得非常出色。當他們看到產品的效果以及它對患者的影響時，就會對產品充滿信心。

As you mentioned, we know that more than 75% of the physicians or patients that are out there are continuing to experience symptoms, so they need something different. And so we remain committed to our strategy. We’re pleased to see that it does get some utilization first-line, as you noted, that we’re indicated from a first-line basis. But we remain committed and very confident with what we saw in Q3 and the momentum that we’re generating coming into Q4.

正如您所提到的，我們知道超過 75% 的醫生或患者仍在經歷症狀，因此他們需要一些不同的方法。因此，我們將繼續堅持我們的策略。我們很高興看到它確實在一線中得到了一些利用，正如您所指出的，我們被列為一線人員。但我們仍然堅定不移，並且對第三季度取得的成績以及進入第四季度的良好勢頭充滿信心。

Yigal, Citi.

Yigal，花旗銀行。

Hi, this is (inaudible) on for Yigal. Congrats on the quarter, and thanks for taking our question. Maybe just two quick ones for us. I know you had commented on solubility and potency, but just wondering if you could provide a little bit more color on what 531 is hoping to solve that was suboptimal versus tenapanor.

大家好，這裡是（聽不清楚）為Yigal主持節目。恭喜您本季取得佳績，感謝您回答我們的問題。或許我們只需要快速解決兩個問題。我知道您曾經評論過溶解度和效力，但我只是想知道您能否更詳細地說明一下 531 希望解決的哪些問題（與 tenapanor 相比，這些問題並不理想）。

So versus tenapanor is one way to look at it. When you have highly soluble, gut-restricted drugs, you may have better penetration into the target of NHE3. Solubility matters to have a molecule do what it needs to do where you’re trying to target it.

所以，與 tenapanor 相比，這是一種看待這個問題的方式。對於高度溶解、腸道限制性藥物，它們可能更容易滲透到 NHE3 標靶。溶解度對於分子能否在目標區域發揮其應有的作用至關重要。

Potency will bring you lower doses or better efficacy. And that’s exactly the preclinical work that we’re embarking upon, to understand how best to leverage those qualities of this molecule. As I said in the previous question, it’s premature for us to speak as to whether or not it is to answer questions that tenapanor can’t or if there are other indications that make more sense to pursue.

效力增強意味著更低的劑量或更好的療效。而這正是我們正在進行的臨床前研究工作，旨在了解如何最好地利用該分子的這些特性。正如我在上一個問題中所說，現在談論它是否是為了回答 tenapanor 無法回答的問題，或者是否有其他更有意義的跡象值得追查，還為時過早。

Got it. And maybe just one more, if I may. It seems like IBSRELA is really continuing to take off due in part to the investment into the Salesforce. I am just wondering, as you’re seeing that there’s still a big opportunity there, is there any consideration for perhaps increasing the Salesforce even further beyond what you had already done to reach that peak 750 as early as possible?

知道了。如果可以的話，也許再加一個吧。IBSRELA 的發展勢頭似乎持續強勁，部分原因在於對 Salesforce 的投資。我只是想知道，既然您認為那裡仍然有很大的機會，是否有可能在現有基礎上進一步擴大 Salesforce 規模，以便盡快達到 750 人的峰值？

I mean, the one is just a general comment. I’ll ask Eric to comment on the specifics. Every day, we think about where else we can invest in this growth and this opportunity because what we see here in terms of the benefits providing patients, the organic growth that the previous question had in terms of moving into first-line, this is a very good drug that’s helping a lot of people, and there are a lot of people that aren’t being helped by it yet because of the breadth, depth, and reach.

我的意思是，那條評論只是泛泛而談。我會請埃里克就具體細節發表評論。我們每天都在思考還能在哪些方面投資於這種增長和這種機遇，因為我們在這裡看到的是它為患者帶來的益處，以及之前提到的在進入一線治療領域方面的自然增長，這是一種非常好的藥物，它正在幫助很多人，但由於其廣度、深度和覆蓋範圍的限制，還有很多人尚未從中受益。

There are many ways to communicate with those HCPs and those patients, and that broad-based approach is what we will always consider. We will always look at new and better ways to penetrate but certainly investing those considerations and investing in whether it’s the fans, the Salesforce is something that Eric always considers.

與這些醫護人員和病患溝通的方式有很多種，而這種廣泛的溝通方式正是我們總是會考慮的。我們會不斷尋找新的、更好的方法來滲透市場，但當然，投資這些因素，以及投資是否能吸引粉絲，Salesforce 是 Eric 一直在考慮的事情。

Yeah, thanks for that question. As Mike said, we’re constantly looking at the data to see where we can continue to drive growth and value. As we’re looking at the Salesforce, just recall we’re now about three to four full quarters in with the expanded Salesforce, and what they’ve done is really raised the bar.

謝謝你的提問。正如麥克所說，我們一直在研究數據，看看我們可以在哪些方面繼續推動成長和創造價值。當我們審視 Salesforce 時，請記住，Salesforce 擴充版已經運行了大約三到四個季度，他們所做的一切確實提高了標準。

So right now, I’ve got great confidence in this team. We’re well on our path to achieve $1 billion peak year sales. And as we go into Q4, feel really confident about where the team is. We’ll continue to look at the size of the field team, but we remain confident there. I also just want to take the opportunity to remind you, it’s not just the field team.

所以現在，我對這支球隊充滿信心。我們正朝著實現年銷售額高峰10億美元的目標穩步前進。進入第四季度，我對團隊的現狀感到非常有信心。我們將繼續關注現場團隊的規模，但我們對此仍然充滿信心。我還想藉此機會提醒大家，這不只是現場團隊的事。

We’ve got great marketing initiatives out there. We’ve got a wonderful field access manager team that’s focused on pull-through. It’s really a team effort out there that’s driving the growth of IBSRELA.

我們有很多很棒的行銷活動。我們擁有一支優秀的現場准入管理團隊，專注於提升客戶轉換率。IBSRELA 的發展壯大，離不開團隊的共同努力。

Fantastic. Congrats on the quarter again, guys. Appreciate it.

極好的。再次恭喜各位取得佳績！謝謝。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

Hey, everyone. Good afternoon. A couple from me. One for thinking about IBSRELA. What pushes and pulls could impact your ability to reach the high versus low end of your new guidance? It did sound like you’re making great strides with new and repeat prescribers as well. Could you give us a little bit more color? What’s resonating there?

大家好。午安.我這裡也有一對。一個值得思考的 IBSRELA。哪些因素會影響您達到新指導目標的上限或下限的能力？聽起來您在與新舊處方醫生的溝通方面也取得了很大進展。能再詳細描述一下嗎？在那裡引起了哪些共鳴？

Yeah, I mean, I think the guidance reflects our confidence in what we are doing with all the questions you’ve heard previously. I think that increased guidance in the range that we’ve provided is to show you our confidence in what we’re going to deliver this year.

是的，我的意思是，我認為該指南體現了我們對自身工作的信心，也回應了你們之前聽到的所有問題。我認為，我們擴大預期範圍是為了向你們表明我們對今年將要實現的目標充滿信心。

I think Eric can go into some more of the specifics around it, but that should speak for itself. I think, Roanna, you’ve known us over the years that we’ve taken a pretty conservative approach in the way that we provide these numbers, and what we do is give you numbers that we are confident that we’re going to meet. That’s been consistently the way we’ve approached it over the years.

我認為艾瑞克可以就此做一些更具體的說明，但這應該足以說明問題了。羅安娜，我想，這些年來你也知道，我們在提供這些數據時一直採取相當保守的做法，我們所做的就是給你我們有信心能夠實現的數字。多年來，我們一直都是這樣處理這件事的。

Yeah, like I said earlier, I mean, we’re very confident in the strategy we have. If you think a little bit about what I mentioned earlier, we know that there are millions of patients out there that have been on or are on secretagogues. Again, more than 75% of those patients continue to experience symptoms of IBS-C, and what they need is something different.

是的，就像我之前說的，我們對我們的策略非常有信心。如果你稍微想想我前面提到的內容，我們就知道有數百萬患者曾經或正在服用促分泌劑。再次強調，超過 75% 的患者仍然會出現便秘型腸躁症 (IBS-C) 的症狀，他們需要的是不同的治療方法。

We know that this is a multifactorial disease, and they need something that potentially offers a different mechanism with a proven safety and efficacy profile. I mentioned the poster at the American College of Gastroenterology that was just presented showing that more than 85% of the patients out there were satisfied with IBSRELA. We have a great opportunity out there to address a high unmet need in this patient population, and we continue to be confident with the strategy.

我們知道這是一種多因素疾病，他們需要一種可能提供不同機制且具有已證實的安全性和有效性的藥物。我提到了剛剛在美國胃腸病學會上展示的海報，該海報顯示超過 85% 的患者對 IBSRELA 感到滿意。我們擁有一個絕佳的機會來滿足這群患者中尚未得到充分滿足的需求，我們對這項策略仍然充滿信心。

Got it. Thanks. One question on 531. It did sound like it’s just the beginning of building the pipeline. I was curious if there are any other targets or molecules that you’re interested in or would consider, and is external BD also an option?

知道了。謝謝。531號題有一個問題。聽起來這似乎只是管道建設的開始。我很好奇您是否還有其他感興趣或會考慮的目標或分子，外部業務拓展也是選項嗎？

To the second part first, as you know, just under two years ago, we brought in Mike Kelleher to lead our Corporate Development efforts, and he and his team are always looking and speaking to opportunities that are out there. We will pull the trigger on things when the right thing is there for us. As I said in my opening comments, we’re now at a place where we could look at these assets that we had sitting on the shelf because they’re really good. Are there other ones? There may be, but our focus at this point for our internal pipeline, generated pipeline is 531.

先說第二部分，如您所知，大約兩年前，我們聘請了麥克·凱萊赫來領導我們的企業發展工作，他和他的團隊一直在尋找和洽談各種機會。我們會等到適當的時機才會採取行動。正如我在開場白中所說，我們現在可以審視我們之前擱置的這些資產了，因為它們真的很好。還有其他的嗎？或許有，但目前我們內部管道的重點是 531。

Makes sense. Thanks.

有道理。謝謝。

Dennis Ding, Jefferies.

丹尼斯丁，傑富瑞集團。

Hey, guys. Congrats on the quarter. Two questions for me. One on IBSRELA. You guys are running trials in peds less than 18 years old. Can you help frame the size of that market versus the adults and if that is already accounted for in your $1 billion peak sales guidance? Also, maybe comment on the timing of clinical trials to go into CIC.

嘿，夥計們。恭喜你本季取得佳績。我有兩個問題。IBSRELA 上的一個。你們竟然在18歲以下的兒童身上進行試驗。您能否幫忙分析該市場規模與成年人市場規模的對比，以及這是否已包含在您 10 億美元的銷售高峰預期中？另外，或許可以談談臨床試驗進入CIC階段的時間安排。

Number two, on XPHOZAH. Congrats on the progress there, but there’s still quite a large gap between where XPHOZAH is now and the $750 million you guys are guiding. What are things that are within your control to really accelerate that? Thank you.

第二名，在 XPHOZAH。恭喜你們的進展，但 XPHOZAH 目前的規模與你們設定的 7.5 億美元目標之間仍然存在相當大的差距。有哪些事情是你能夠掌控的，可以真正加速這個進程？謝謝。

Sure. Thanks for the questions, Dennis. If you look at where we are with IBSRELA, the pediatric trials were a commitment that you have to make to the agency. I think if you look at the total prescriptions that are out there for IBS-C, it includes those. The market that we’re all penetrating is relatively small, but any IBS-C drug, those are included in the prescriptions there.

當然。謝謝你的提問，丹尼斯。如果你看看我們與 IBSRELA 的進展，你會發現兒科試驗是你必須對機構做出的承諾。我認為，如果你查看所有用於治療便秘型腸躁症 (IBS-C) 的處方，你會發現其中就包括這些。我們共同開拓的市場相對較小，但任何治療便秘型腸躁症的藥物，都包含在該市場的處方中。

We’ve not specified whether or not we are counting on that to get to the billion because we’re just looking at the total market as the market that we’re penetrating. For CIC, we’ve not spoken of doing anything there. It’s obviously, as I spoke in your last meeting in London, that is obviously one that we would consider. As we have the ability to pay for it, those are the sorts of things we will look at.

我們尚未具體說明是否指望透過這種方式達到十億的目標，因為我們只是將整個市場視為我們正在滲透的市場。至於CIC，我們還沒有討論過在那裡進行任何活動。正如我在上次倫敦會議上所說，這顯然是我們會考慮的。既然我們有能力支付，那麼這些就是我們會考慮的事情。

As it relates to XPHOZAH, I think as we’ve talked about this, it’s important to note that when we ended last year, we lost 60% of the revenue that was being generated by XPHOZAH in an incredibly tumultuous market for these patients that are depending upon effective phosphorus management to survive in many cases. That turmoil is real. It’s significant.

關於 XPHOZAH，我認為正如我們之前討論過的，需要指出的是，去年年底，我們失去了 XPHOZAH 60% 的收入，而對於許多依賴有效磷管理才能生存的患者來說，這是一個極其動蕩的市場。這種動盪是真實存在的。這意義重大。

We just put numbers on the board that are as good, if not better, even having lost that 60% of the revenue for the entire portfolio. The strength of this team and what we’ve done, I think, is what you see in the results that we’re speaking of today. We have great confidence in our ability to get to the $750 million. I will leave it at that because we’ve spoken about the specifics numerous times.

即使整個投資組合的收入損失了 60%，我們仍然取得了同樣好甚至更好的成績。我認為，我們今天所看到的成績，正是這支隊伍的實力和我們所取得的成就的體現。我們非常有信心達到 7.5 億美元的目標。我就說到這裡吧，因為我們已經討論過許多具體細節了。

It’s a third of the TAM that we now have of 220,000 patients is what is required to $750 million. If the need is as extensive and significant as we believe it is and demonstrated both by the paying and the patient assistance program patients, the turmoil that’s at that period is turmoil. Once you get past that, likely that’s going to change.

我們現在擁有的 TAM（22 萬名患者）的三分之一，就是所需的 7.5 億美元。如果需求像我們認為的那樣廣泛和重大，而付費患者和患者援助計劃患者都證明了這一點，那麼那段時間的混亂就是混亂。一旦你克服了這一點，情況很可能會改變。

Laura Chica, Wedbush Securities.

Laura Chica，Wedbush Securities。

Hi, good afternoon. This is Thomas from Laura Chico. Thank you so much for taking our questions today. Just one from us. You discussed gross-to-net for 3Q earlier for XPHOZAH. Any thoughts on gross-to-net dynamics heading into 2026, and how might this compare to 2025 levels?

您好，下午好。這是來自勞拉·奇科的托馬斯。非常感謝您今天回答我們的問題。我們只提供一份。您之前討論過 XPHOZAH 第三季的毛利潤與淨利潤之間的關係。對於2026年毛利潤與淨利的走勢，您有什麼看法？與2025年的水準相比，情況會如何？

Thank you, Thomas. Our growth in that was approximately 29% for Q3, and we do think that will be somewhat consistent going to Q4. We’re not in a position yet to discuss specifics around 2026. Look for us to update that in early 2026.

謝謝你，托馬斯。第三季我們的成長率約為 29%，我們認為第四季這一數字將保持相對穩定。我們目前還不具備討論 2026 年具體細節的條件。我們將在 2026 年初更新相關資訊。

Matthew Caulfield, H.C. Wainwright.

馬修·考菲爾德，H.C. 溫賴特。

Great. Hi. Thank you, guys. When we think about XPHOZAH and getting those prescriptions filled, should these essentially be primarily filled through Ardelyx Assist and the patient’s pharmacy at this stage, or are there scenarios where the drug could come through the dialysis center experience despite being external to the bundle, for example? Just trying to kind of best understand the patient journey there to access and growth. Thanks.

偉大的。你好。謝謝大家。當我們考慮 XPHOZAH 以及如何配藥時，這些處方是否應該主要透過 Ardelyx Assist 和患者的藥房來配藥，或者是否存在藥物可以透過透析中心獲得，即使它不在套餐內的情況？我只是想盡可能地了解患者在那裡獲得醫療服務和康復的歷程。謝謝。

Yeah, sure. That’s an important question, I think, to really understand how we can make sure that these patients have access. As we said earlier, we remain committed to access for these patients regardless of who the payer is.

當然可以。我認為這是一個重要的問題，我們需要真正了解如何確保這些患者能夠獲得醫療服務。正如我們之前所說，無論付款方是誰，我們都將繼續致力於保障這些病患的就醫權利。

On the non-Medicare side, it’s covered through their prescription benefit. Ardelyx Assist can adjudicate it, and they can also work with specialty pharmacies to deliver to the patient. On the Medicare side, Ardelyx Assist can fulfill that through our patient assistance program. Because we did not file for TDAPA, the dialysis organizations are not buying and billing it.

對於非健保人群，這筆費用由他們的處方藥福利支付。Ardelyx Assist 可以進行裁決，他們也可以與專科藥局合作，將藥品送到病人手中。在醫療保險方面，Ardelyx Assist 可以透過我們的患者援助計劃來滿足這一需求。由於我們沒有申請TDAPA，透析機構沒有購買和收取費用。

It is important to note, though, what we’ve seen is actually increased access when we think about patients, whether they’re Medicare or non-Medicare. So more patients today have access to XPHOZAH than they ever have before. I think it’s important to note that we’ve got a path to access for these patients, and we’re continuing to be able to address the unmet need for them.

不過值得注意的是，我們看到的其實是，無論患者是否參加醫療保險，他們的就醫機會都增加了。因此，如今比以往任何時候都有更多的患者能夠獲得 XPHOZAH 治療。我認為值得注意的是，我們已經為這些患者找到了就醫途徑，並且我們能夠繼續滿足他們未被滿足的需求。

Joseph Thome, TD Cowen

Joseph Thome，TD Cowen

Hi, there. Good evening. Congrats on the progress, and let me add my best of luck to Justin. Thank you for taking our questions.

你好呀。晚安.恭喜你的進展，也祝賈斯汀好運。感謝您回答我們的問題。

Maybe the first one on the new program. I guess anything that you can share on the profile of this drug, whether it’s extended release? Or is there a way to, I guess, improve tolerability? Obviously, the NHE3 mechanism does result in some diarrhea. I guess, is that able to be modulated given that it’s kind of (multiple speakers)

或許是新節目中的第一個。我想請您分享一下關於這種藥物的概況，例如它是否是緩釋劑型？或者，有沒有什麼辦法可以提高耐受性？顯然，NHE3 機制確實會導致一些腹瀉。我想，鑑於它某種程度上是可以調節的，那麼它是否能夠被調節呢？（多位發言者）

Great question. Those are obviously the things that you begin to explore in the preclinical work that you’re doing. We have obviously years and years of experience and knowledge around the translation of what you see in animal models all the way through to human experience. That’s one thing that we would look at. The benefit that we together have learned about what NHE3 inhibition does, right, it’s blocking sodium.

問得好。這些顯然是你在臨床前工作中開始探索的內容。我們顯然擁有多年經驗和知識，能夠將動物模型中的現象轉化成人類的經驗。這是我們會考慮的一個面向。我們共同了解到 NHE3 抑制劑的作用，對吧，它能阻斷鈉離子。

Fundamentally, that’s what it does. It’s tightening the junctions. That’s where it works in phosphorus. That was not predictable. It also has a benefit in pain, which one would never assume that that was the case until you started the IBS-C work.

從根本上講，它的作用就是這樣。它正在收緊連接處。這就是它在磷中起作用的地方。這出乎我的意料。它還能緩解疼痛，這一點在開始治療便秘型腸躁症之前，人們永遠不會想到。

Those three different things that this molecule, NHE3 inhibition, does open a vista for lots of things to consider, contemplate exactly around the lines of what you’ve questioned. Time will tell. It is early in the process, but we were excited to announce its development.

這種分子（NHE3 抑制劑）的這三個不同特性，為許多值得思考和考慮的事情打開了視野，正好與你提出的問題相關。時間會證明一切。雖然目前還處於早期階段，但我們很高興地宣布這項進展。

Yeah, a little bit related to that, I guess maybe can you talk a little bit about why now was the right time? I guess, did you see anything preclinically that you can share that kind of triggered the announcement or anything in the field? I guess, or is it just kind of continued progress and now is the time? I guess, anything around that?

是的，這有點關係到這個問題，我想您能談談為什麼現在是合適的時機嗎？我想問的是，您在臨床前研究中是否發現了什麼可以分享的訊息，促使您發布這份公告？或者您在研究領域中發現了什麼？我猜是這樣，或者說這只是持續進步，現在時機成熟了？我想，大概就是這個意思吧？

I kind of talked about it in a couple of previous questions. If you look at the balance sheet that we have, we’ve not raised any money for years, and it’s on the basis of what we’re driving with IBSRELA and XPHOZAH that the balance sheet is as strong as it is.

我在之前的幾個問題中已經稍微提到過這一點。如果你看一下我們的資產負債表，就會發現我們已經多年沒有籌集任何資金了，正是基於我們透過 IBSRELA 和 XPHOZAH 所取得的成就，我們的資產負債表才如此強勁。

We had a very short dip after the end of or the start of the TDAPA period, and we’re back with a balance that is what was prior to the start of the TDAPA period. That’s an incredible accomplishment. That then said to me and the team, we can begin to afford to explore other things that we might be able to do to build this company. 531 was an obvious choice because it was something we knew pretty well, and we began to pursue that.

在 TDAPA 時期結束或開始之後，我們經歷了非常短暫的下跌，現在我們的餘額已經恢復到 TDAPA 時期開始之前的水平。那真是一項了不起的成就。這讓我和團隊意識到，我們可以開始探索其他可能有助於公司發展的方向。 531 顯然是一個不錯的選擇，因為我們對它非常熟悉，所以我們開始著手研究它。

I think, as you heard in my comments, I think this demonstrates that we’ve been extremely good and thoughtful stewards of the capital that we have. I think this is an example of how we plan on deploying.

我認為，正如你從我的評論中聽到的那樣，這表明我們一直以來都是對我們所擁有的資本非常優秀和深思熟慮的管理者。我認為這是我們計劃如何部署的一個例子。

Julian Harrison, BTIG.

Julian Harrison，BTIG。

Hi. Thank you for taking my questions. It’s great to see another beat and raise for IBSRELA. You’re at more than 70% YoY growth at the lower end of the new range for 2025. Looking to next year and beyond, I’m curious to what extent you think this cadence of growth can persist.

你好。謝謝您回答我的問題。很高興看到 IBSRELA 再次取得佳績並籌集資金。你們的年成長率在 2025 年新目標範圍的下限超過了 70%。展望明年及以後，我很想知道您認為這種成長節奏能在多大程度上持續下去。

Looking towards the intellectual property state, are you at a point now where you can talk more about how you’re exploring extending exclusivity potentially beyond composition of matter? Are there any pending patent applications that you would highlight as potentially being Orange Book eligible?

展望知識產權現狀，您現在是否可以更詳細地談談您如何探索將獨佔權擴展到物質組成之外？您認為目前有哪些正在申請的專利有可能符合橙皮書的要求？

Yeah. Great questions. It is exactly what we are doing and should be doing to protect the franchise that we’re building. Yes, of course, those things are all the things that we will contemplate and talk about when we can. I think what’s important about your question is the growth that you see. As you described for IBSRELA, the potential is spectacular, right?

是的。問得好。這正是我們正在做，也應該做的，以保護我們正在建立的特許經營權。當然，這些都是我們有時間的時候會思考和討論的事情。我認為你問題的關鍵在於你所看到的成長。正如你對 IBSRELA 的描述，它的潛力是巨大的，對吧？

If you look at the number of scripts that we have compared to the market that’s out there and the growth that is being driven by the need that’s out there for the patients by LINZESS and others, that is to our benefit over time. Our belief is that reaching that $1 billion is something that’s well within our control, or we wouldn’t have said that we expect it to be there.

如果你看看我們擁有的處方數量與市場上的處方數量，以及LINZESS和其他公司為滿足患者需求而推動的增長，從長遠來看，這對我們來說是有利的。我們相信，達到 10 億美元的目標完全在我們掌控之中，否則我們不會說我們期望達到這個目標。

I think as we gain and continue to gain more perspectives and guidance, we can provide more guidance on when and how that is achieved. We’re excited about the future for IBSRELA and what we’re doing now, certainly with IBS-C and hyperphosphatemia with XPHOZAH. This mechanism, these drugs are making a huge difference. It’s the work that Eric and his team are doing to show that conviction in physicians and getting those prescriptions pulled through.

我認為，隨著我們獲得更多視角和指導，我們可以就何時以及如何實現這一目標提供更多指導。我們對 IBSRELA 的未來以及我們現在正在做的事情感到興奮，尤其是在 IBS-C 和 XPHOZAH 治療高磷血症方面。這種機制，這些藥物，正在產生巨大的影響。這是艾瑞克和他的團隊正在努力的工作，旨在向醫生們展現這種信念，並促使這些處方最終得以實施。

Aydin Huseynov, Ladenburg Thalmann.

艾丁‧侯賽諾夫，拉登堡‧塔爾曼。

Hi, good afternoon. Thanks for taking questions and congrats with a great commercial quarter. Regarding business development activities, just curious on the kind of assets you’re looking for. Is it more like a GI space, or is it more like an early-stage Phase 1 preclinical? Or would you prefer something like phase three, plug and play, or complementary to your commercial portfolio?

您好，下午好。感謝您回答問題，並祝賀您本季業績斐然。關於業務拓展活動，我很好奇您正在尋找哪一類資產。它比較像是胃腸道領域，還是比較像是早期第 1 期臨床前研究？或者您更傾向於第三階段、即插即用或與您的商業產品組合互補的產品？

The answer is yes to all of that at the right time, right? We’re going to take some baby steps as we can begin to afford to do more. The natural thing is to look at the therapeutic areas and the close adjacencies of the therapeutic areas that we’re currently in.

答案是肯定的，只要時機合適，對吧？我們將循序漸進，等到經濟條件允許時再逐步增加投入。很自然地，我們會審視我們目前所處的治療領域以及與這些治療領域密切相關的領域。

Like any biotech company, we’re going to be opportunistic as something demonstrates itself. Me too is not very interesting. Even me better, not very interesting. I think this very special and unique way that we approach commercialization is a really important driver of the considerations that we have for things to bring in. That’s the lens from which we look at things. I think in the coming year, for sure, you’re going to be hearing much more of that as we get our legs under us and look at opportunities that we are confident that we will bring in.

和其他生技公司一樣，一旦出現機會，我們就會抓住它。「我也是」這個話題沒什麼意思。連我都覺得沒意思。我認為我們這種非常特殊且獨特的商業化方式，是我們考慮引進產品時的重要驅動因素。這是我們看待事物的視角。我認為在未來一年裡，隨著我們站穩腳跟，並著眼於我們有信心能夠帶來的機遇，你們肯定會聽到更多這樣的消息。

Thank you, Mike. One more general question for me. You’re making almost $400 million in annual sales. You give about $7.5 billion long-term guidance, and yet you’re traded on a $1.2 billion market cap. What do you think the market is underestimating? The long-term guidance itself or the future after 2033? Just curious on your thoughts on this.

謝謝你，麥克。我還有一個比較一般性的問題。你們的年銷售額接近 4 億美元。你們給了約 75 億美元的長期業績指引，然而你們的市值卻只有 12 億美元。你認為市場低估了什麼？是指長期指導方針本身，還是指2033年以後的未來？只是好奇你對此有何看法。

I’ll be completely transparent with you. We’ve talked about this before. I think there’s an over-index on XPHOZAH, not giving this engine that we have at IBSRELA the attention that it’s due. What you see in terms of the growth and the benefit that it provides us in profit and operating cash for us to reinvest in the business, whether it is to expand our capacity and capabilities on the commercial side, we will be thoughtful and measured in that.

我會對你完全坦誠。我們之前討論過這個問題。我認為對 XPHOZAH 的關注度過高，沒有給予 IBSRELA 的這款引擎應有的關注。我們會認真考慮成長帶來的收益，以及利潤和營運現金流，以便我們能夠再投資於業務，無論是擴大我們在商業方面的產能和能力，我們都會謹慎行事。

Also, as we look at other things to bring in, it is something that we are looking forward to as we are on the cusp of generating that kind of free cash to build this company even further. I think we don’t get that credit I think if you look at many of the buy and the sell side, they are expecting at LOE, we may or may not make a billion. There’s no consistency even in the way that people look at this product or products and whether or not they’re giving them their due in the modeling that they do.

此外，當我們考慮引進其他產品時，我們非常期待，因為我們即將產生足夠的自由現金流，以進一步發展這家公司。我認為我們沒有得到應有的認可。我認為，如果你看看買賣雙方，他們預期在 LOE 階段，我們可能會也可能不會賺到 10 億美元。人們看待這款產品或這些產品的方式並不一致，他們是否在模特兒工作中給予這些產品應有的評價也存在分歧。

That’s our job, right, to also work with each of you to work on that. I think it’s a bunch of those things. I can tell you the truth that I hope by now we’re beginning to get out of the penalty box of we’re a show-me story. I think we’ve shown everyone again and again and again a meet and beat. And that this is a substantive, big, and important market, certainly for IBSRELA. As I said in my opening remarks, XPHOZAH is a contributor to that portfolio and will only continue to provide better contribution over time.

這就是我們的工作，對吧，也要和你們每個人一起努力。我覺得是這些因素的綜合。我可以坦誠地告訴你，我希望我們現在已經開始走出困境，不再只是「拿出真本事」的故事了。我認為我們已經一次又一次地向大家展示了我們的實力。而且，對 IBSRELA 來說，這無疑是一個實質的、規模龐大的、重要的市場。正如我在開場白中所說，XPHOZAH 是該投資組合的貢獻者，隨著時間的推移，它只會繼續做出更大的貢獻。

Pakar Agrawal, Cantor Fitzgerald.

帕卡·阿格拉瓦爾，坎托·菲茨杰拉德。

Hi, this (inaudible) on for Pakar. Could you comment on any potential tailwinds or headwinds in 2026 that we should be aware of for IBSRELA and XPHOZAH? Thank you.

嗨，這是帕卡爾的（聽不清楚）。您能否就 2026 年 IBSRELA 和 XPHOZAH 可能面臨的任何潛在利多或不利因素發表一些看法？謝謝。

I can't think of any. I think we’re looking forward to getting out of the auspices of what the bundle is doing for these patients and being able to help them to the degree that we believe we can and should. The turmoil is significant. I think that’s not a headwind. I think that’s a tailwind that ultimately is going to help us as we emerge from 2026 with this remarkable product. I think there are only tailwinds for both of them, not only because I’m an optimist, but I think everything that we’re sharing with you today says that we’ve got the wind in our sails that are going to help propel us to, at a minimum, the guidance that we’ve given for peak for both.

我想不出任何例子。我認為我們期待著擺脫目前這些患者所受到的照顧，並能夠盡我們所能地幫助他們。這場動盪意義重大。我認為這不算逆風。我認為這將是一股順風，最終將幫助我們帶著這款卓越的產品走出2026年的困境。我認為他們倆都只有順風，這不僅是因為我樂觀，而且我認為我們今天與你們分享的一切都表明，我們已經乘風破浪，這將至少幫助我們達到我們為兩者設定的巔峰目標。

That concludes our question-and-answer session. With that, I’ll turn the program back over to our host for any closing comments.

我們的問答環節到此結束。接下來，我將把節目交還給主持人，請他作總結發言。

Thank you, everyone, for joining the call today. We entered the fourth quarter with confidence in our strategy and enthusiasm for the future. We have the medicines, the focus on execution, and the team in place to deliver on our vision of a healthier tomorrow for patients.

感謝各位今天參加電話會議。我們帶著對自身戰略的信心和對未來的熱情進入了第四季。我們擁有所需的藥物、對執行的重視以及團隊，能夠實現我們為患者創造更健康未來的願景。

I’d like to recognize our employees, the people behind every number that we shared today. Their hard work, ingenuity, and resilience continue to drive our success. Together, team Ardelyx is determined to make a difference. I’d like to end by thanking our shareholders for your continued trust and support. We remain focused on driving sustainable growth and creating long-term value for you. With that, we can close the call.

我想感謝我們的員工，感謝他們為我們今天分享的每一個數字所做的貢獻。他們的辛勤工作、聰明才智和堅韌不拔的精神不斷推動著我們的成功。Ardelyx 團隊齊心協力，決心有所作為。最後，我要感謝各位股東一直以來的信任與支持。我們將繼續致力於推動永續成長，並為您創造長期價值。至此，我們可以結束通話了。