Ardelyx Inc (ARDX) 2025 Q2 法說會逐字稿

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

大家好，歡迎參加 Ardelyx 2025 年第一季（原文如此 - 第二季）財報電話會議。（操作員指示）

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

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

Thank you. Good afternoon, and welcome to our second-quarter 2025 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investor section of the company's website at ardelyx.com.

謝謝。下午好，歡迎參加我們的 2025 年第二季財務業績電話會議。在本次電話會議中，我們將參考今天稍早發布的新聞稿，該新聞稿可在公司網站 ardelyx.com 的投資者部分查閱。

During this call, we 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 recently -- our most recent quarterly report on Form 10-Q that will be filed today and can be found on our website at ardelyx.com. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change.

在本次電話會議中，我們將做出具有風險和不確定性的前瞻性陳述。我們的實際結果可能與所描述的結果有很大差異。我們鼓勵您閱讀我們最新的10-Q表季度報告中的風險因素，該報告將於今日提交，可在我們的網站ardelyx.com上查閱。雖然我們未來可能會選擇更新這些前瞻性陳述，但我們明確聲明，即使我們的觀點發生變化，我們也不承擔任何更新這些前瞻性陳述的義務。

Our President and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's progress during the second quarter of 2025. Next, Chief Commercial Officer, Eric Foster will provide an update on the performance of IBSRELA and XPHOZAH. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the second quarter ended June 30, 2025, before we open the call to questions.

我們的總裁兼執行長 Mike Raab 將在今天的電話會議上致開幕詞並概述公司在 2025 年第二季度的進展情況。接下來，首席商務長 Eric Foster 將介紹 IBSRELA 和 XPHOZAH 的最新表現。在我們開始提問之前，財務和營運長賈斯汀·倫茨 (Justin Renz) 將在今天的準備好的演講結束時回顧公司截至 2025 年 6 月 30 日的第二季度的財務業績。

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

說完這些，讓我把電話轉給麥克。

Good afternoon. It's a pleasure to be with you today to share our second-quarter 2025 results, a quarter that reflects the strength of our strategy, the momentum behind our products, and exceptional execution by our team. We're proud to report a standout quarter for both IBSRELA and XPHOZAH, reinforcing the power of our commercial model and the real world impact our differentiated therapies are having for patients with IBS-C and CKD on dialysis. These results validate our strategy and highlight our ability to deliver on our priorities.

午安.今天很高興與大家分享我們 2025 年第二季的業績，這一季度反映了我們策略的實力、我們產品背後的動力以及我們團隊的卓越執行力。我們很自豪地報告 IBSRELA 和 XPHOZAH 在本季度均表現出色，這增強了我們商業模式的力量以及我們的差異化療法對接受透析的 IBS-C 和 CKD 患者的現實影響。這些結果驗證了我們的策略，並凸顯了我們實現優先事項的能力。

In the second quarter, we generated $97.7 million in total revenue, representing 33% year-over-year growth, a strong signal of accelerating demand across our portfolio. IBSRELA continues to perform, with net sales revenue of $65 million during the second quarter, up 84% year over year and 46% quarter over quarter.

第二季度，我們的總收入為 9,770 萬美元，年增 33%，這強烈表明我們的整個產品組合的需求正在加速成長。IBSRELA 繼續表現出色，第二季淨銷售收入為 6,500 萬美元，較去年同期成長 84%，較上季成長 46%。

IBSRELA demand growth is broad-based, with record highs across all our key indicators. Our Ardelyx team has done an exceptional job expanding reach, deepening prescriber engagement, conviction, and prescription pull through. Given this outstanding momentum, we are raising our full-year 2025 net sales revenue guidance for IBSRELA to $250 million to $260 million, a meaningful step forward as we scale the opportunity ahead for this important medicine.

IBSRELA 需求成長基礎廣泛，我們所有關鍵指標均創歷史新高。我們的 Ardelyx 團隊在擴大覆蓋範圍、深化處方者參與度、信念和處方通過率方面做得非常出色。鑑於這一出色的勢頭，我們將 IBSRELA 2025 年全年淨銷售收入預期上調至 2.5 億至 2.6 億美元，這對於我們擴大這一重要藥物的未來機會而言是一個有意義的進步。

XPHOZAH posted a very encouraging quarter as well. With a changed market landscape, XPHOZAH recorded net sales revenue of $25 million, up 7% compared to the first quarter of this year, and when adjusted for the one-time reserve that was released in Q1, net sales grew 27%. This performance speaks volumes about the strength and agility of the XPHOZAH team as they help guide healthcare providers to this changed landscape.

XPHOZAH 也發布了一個非常令人鼓舞的季度業績。隨著市場格局的變化，XPHOZAH 的淨銷售收入達到 2,500 萬美元，比今年第一季成長 7%，經調整第一季釋放的一次性儲備後，淨銷售額成長了 27%。這一表現充分說明了 XPHOZAH 團隊的實力和敏捷性，他們幫助醫療保健提供者適應這一變化的情況。

Our Q2 results further strengthens our conviction for the significant opportunity we have ahead as we drive continued growth for XPHOZAH. Notably, our strong commercial execution and continued discipline investments in our business has resulted in a meaningful quarter-over-quarter improvement in net loss as well.

我們第二季的業績進一步增強了我們的信心，讓我們相信在推動 XPHOZAH 持續成長的過程中，我們擁有巨大的機會。值得注意的是，我們強大的商業執行力和對業務持續的紀律投資也導致淨虧損較上季顯著改善。

Additionally, we strengthened our balance sheet and further enhanced our financial flexibility by drawing an additional $50 million of debt. As we progressed, we've also thoughtfully scaled the organization and we've been deliberate in strengthening our leadership team to match the opportunity ahead.

此外，我們還透過額外借入 5,000 萬美元的債務來加強我們的資產負債表並進一步提高我們的財務靈活性。隨著我們的進步，我們也深思熟慮地擴大了組織規模，並有意加強我們的領導團隊以適應未來的機會。

Over the past 18 months we've added transformative talent that will help guide us into our next phase of growth. We recently promoted Mike Kelliher to Chief Business Officer and appointed Laura Williams as Chief Patient Officer. We also welcome three dynamic and experienced leaders to our executive team, Ed Conner as Chief Medical Officer; John Bishop as Chief Technical Operations Officer; and Jamie Brady as Chief Human Resources officer. This group brings deep expertise, vision, and executional excellence, exactly what we need as we execute on our ambition to create a significant enterprise and build a company of lasting impact.

在過去的 18 個月裡，我們增加了變革人才，這將有助於我們進入下一階段的成長。我們最近提升 Mike Kelliher 為首席商務官，並任命 Laura Williams 為首席病患官。我們也歡迎三位充滿活力且經驗豐富的領導者加入我們的執行團隊，Ed Conner 擔任首席醫療官；John Bishop 擔任首席技術營運長；Jamie Brady 擔任首席人力資源長。這個團隊擁有深厚的專業知識、遠見卓識和卓越的執行力，這正是我們實現創建重要企業和打造具有持久影響力的公司的雄心壯誌所需要的。

As you also saw in the press release we issued early today, Justin Renz, our Chief Financial and Operations Officer, will be leaving the company. Justin has been instrumental in Ardelyx's journey, leading with strength, goodwill, and purpose through periods of both challenge and transformation. He has built a world-class finance organization and positioned us to thrive going forward. We are incredibly grateful to Justin and that he will remain with us to ensure a seamless leadership transition. Justin, thank you for your partnership, your leadership, and your unwavering commitment to our mission.

正如您在我們今天早些時候發布的新聞稿中看到的，我們的財務和營運長賈斯汀·倫茨 (Justin Renz) 將離開公司。賈斯汀在 Ardelyx 的發展歷程中發揮了重要作用，在挑戰和轉型時期以力量、善意和目標引領公司發展。他建立了一個世界級的金融機構，並為我們未來的蓬勃發展奠定了基礎。我們非常感謝賈斯汀，希望他能繼續留在我們身邊，確保領導層的順利過渡。賈斯汀，感謝您的合作、領導以及對我們使命的堅定承諾。

Ardelyx is stronger, more focused, and energized by the opportunities ahead. We're united by a deep commitment to patients backed by best-in-class science and guided by a team that knows how to execute. Our therapies are making a real difference. Our strategy is working and we're well positioned to deliver even greater impact moving forward.

Ardelyx 更強大、更專注，並因未來的機會而充滿活力。我們團結一致，對患者做出堅定承諾，以一流的科學為後盾，並由一支懂得如何執行的團隊指導。我們的療法確實發揮了作用。我們的策略正在發揮作用，我們已做好準備，在未來發揮更大的影響力。

With that, I'll hand it over to Eric, to walk us through our second-quarter commercial performance and how his team will drive continued success in the second half of 2025, and into the future. Eric?

接下來，我將把時間交給 Eric，他將會向我們介紹我們第二季的商業表現，以及他的團隊將如何在 2025 年下半年及未來繼續取得成功。艾瑞克？

Thank you, Mike. It's great to be with you today, and I'm excited to share insights into the performance we delivered during the second quarter and how we plan to maintain that momentum for the remainder of the year.

謝謝你，麥克。很高興今天能和大家在一起，我很高興與大家分享我們在第二季度的業績表現，以及我們計劃如何在今年剩餘時間內保持這種勢頭。

Let me start with IBSRELA. IBSRELA recorded an impressive $65 million in net sales revenue for Q2, demonstrating 84% year-over-year growth and 46% quarter-over-quarter growth. We saw a clear acceleration in demand, delivering our strongest quarter since launch, supported by growth across all key demand indicators compared to the first quarter of this year. This performance was driven by focused commercial execution, which generated growth in both breadth and depth of prescribing and an improvement in prescription pull through.

讓我從 IBSRELA 開始。IBSRELA 第二季的淨銷售收入達到了驚人的 6,500 萬美元，較去年同期成長 84%，較上季成長 46%。我們看到需求大幅加速，創下自推出以來最強勁的一個季度，與今年第一季相比，所有關鍵需求指標均有所成長。這一業績是由專注的商業執行所推動的，這帶來了處方廣度和深度的增長以及處方通過率的提高。

Let me dive into it a bit more, starting with commercial execution. During the quarter, the team drove significant increases in new and total prescriptions through increased field activities to targeted HCPs. We also deployed highly effective marketing activities, including peer-to-peer HCP education programs and digital HCP and consumer engagement. By focusing on increasing the breadth of writers, we generated growth in new writers, new prescriptions, and new patient starts. In addition, existing writers expanded their view of patients they consider candidates for IBSRELA and in turn increased their depth of prescribing.

讓我更深入地探討一下，從商業執行開始。在本季度，該團隊透過增加針對目標 HCP 的現場活動，推動了新處方和總處方的大幅成長。我們也部署了高效的行銷活動，包括點對點 HCP 教育計畫以及數位 HCP 和消費者參與。透過專注於擴大作者的廣度，我們促進了新作者、新處方和新患者數量的成長。此外，現有的作者擴大了他們對 IBSRELA 候選患者的視野，進而增加了他們的處方深度。

We were also pleased to see that refills made up a greater proportion of prescriptions in Q2, which means new prescriptions are spinning off more refills. Both new and refill prescriptions reached all-time highs. We also saw early evidence that the investment in the field access manager team is having a positive impact on our prescription pull through. The team focused on educating offices to ensure that providers can navigate the access landscape if needed.

我們也很高興地看到，第二季續藥佔處方的比例更大，這意味著新處方正在產生更多的續藥。新處方和續處方均創歷史新高。我們也看到了早期證據表明，對現場訪問管理團隊的投資對我們的處方處理產生了積極的影響。該團隊專注於對辦公室進行培訓，以確保提供者在需要時能夠瀏覽訪問環境。

We're seeing early indicators that approval rates and resubmission rates are improving. It is still early for the field access manager team, but we are pleased with the progress and results to date. It has been three full quarters since we completed our sales force expansion, and the field team is hitting their stride. In the second half, they will continue their focus on target HCPs and reinforce IBSRELA's unique and differentiated position as the next choice therapy after trial with a secretagogue. We know that only a quarter of patients on the secretagogue are satisfied, and there remains significant opportunity in the market.

我們看到早期跡象表明批准率和重新提交率正在提高。對於現場訪問經理團隊來說，現在還為時過早，但我們對迄今為止的進展和結果感到滿意。我們完成銷售隊伍擴張已經過了整整三個季度，現場團隊正處於巔峰狀態。下半年，他們將繼續關注目標 HCP，並鞏固 IBSRELA 作為促分泌劑試驗後的下一個選擇療法的獨特和差異化地位。我們知道，只有四分之一的促泌劑患者感到滿意，市場上仍存在著巨大的機會。

We will continue the sales and marketing activities that drove increased demand during the first half of 2025 with the aim of continuing to expand both depth and breadth of the prescribing base. Additionally, our expanded field access team will maintain their focus on improving prescription pull-through to help ensure that all appropriate patients prescribed IBSRELA [and] on treatment.

我們將繼續進行推動 2025 年上半年需求成長的銷售和行銷活動，旨在繼續擴大處方基礎的深度和廣度。此外，我們擴大的現場訪問團隊將繼續專注於改善處方處理，以幫助確保所有合適的患者都開立 IBSRELA 處方並接受治療。

Working with ArdelyxAssist, our team is focused on supporting HCPs to understand the channels that are best equipped to handle prescriptions. The field access manager team also works closely with HCPs to provide prior authorization support to improve patient pull-through.

與 ArdelyxAssist 合作，我們的團隊致力於支持 HCP 了解最適合處理處方的管道。現場訪問管理團隊還與 HCP 密切合作，提供事先授權支持，以提高患者的治癒率。

Coming off a strong Q2 performance, I have full confidence in our team. IBSRELA is an important medicine that delivers meaningful benefits to patients, and our commercial strategy is working. As we look to the second half of the year, we remain focused on executing at a high level and expect our strong momentum to continue. We are raising our guidance for this year. We are confident in our ability to deliver peak sales of more than $1 billion.

由於第二季表現強勁，我對我們的團隊充滿信心。IBSRELA 是一種為患者帶來有意義益處的重要藥物，我們的商業策略正在發揮作用。展望下半年，我們將繼續專注於高水準的執行，並預期強勁勢頭將持續下去。我們正在提高今年的指導。我們有信心實現超過 10 億美元的高峰銷售額。

Now on to XPHOZAH. We are very pleased with the performance that XPHOZAH delivered in the second quarter, delivering $25 million in net product sales revenue. a 27% increase over the first quarter of this year when the onetime Q1 reserve release is excluded, driven by meaningful demand growth. XPHOZAH is an important medicine to help patients achieve target phosphorus levels and our strategy, providing broad-based patient access to XPHOZAH regardless of payer and increasing support for prescription pull-through, is working in the new market environment for phosphate management.

現在轉到 XPHOZAH。我們對 XPHOZAH 在第二季度的業績感到非常滿意，實現了 2500 萬美元的淨產品銷售收入，比今年第一季增長了 27%（不包括一次性第一季儲備釋放），這得益於顯著的需求增長。XPHOZAH 是一種幫助患者達到目標磷水平的重要藥物，我們的策略是讓廣大患者能夠獲得 XPHOZAH，無論付款人是誰，並增加對處方藥的支持，這在磷酸鹽管理的新市場環境中發揮了作用。

We are seeing growth across all key demand indicators, including improved access for patients on both patient assistance and paid prescriptions as well as growth in our non-Medicare payer segments, the total number of writers and new and refill prescriptions. Demand accelerated during the quarter, and we are confident we have the right strategy in place to continue to drive growth in the second half of 2025.

我們看到所有關鍵需求指標都在增長，包括患者獲得患者援助和付費處方的機會改善，以及非醫療保險支付方部門、開藥員總數以及新處方和續處方數量的增長。本季需求加速成長，我們相信我們已製定正確的策略，將在 2025 年下半年繼續推動成長。

Taking a closer look at some of the factors beyond the Q2 results. This market, like IBSRELA, is responsive to the promotional messaging from our film-based area of business directors and our marketing efforts. Since the beginning of the year, the field and marketing teams have been focused on ensuring HCPs understand the access path for XPHOZAH, and we are seeing positive signs that this messaging is resonating.

仔細研究第二季業績以外的一些因素。與 IBSRELA 一樣，這個市場對我們電影領域業務總監的宣傳訊息和我們的行銷努力做出了積極回應。自今年年初以來，現場和行銷團隊一直致力於確保 HCP 了解 XPHOZAH 的獲取途徑，我們看到了這種資訊正在引起共鳴的積極跡象。

Total dispenses, including both patient assistance and paid prescriptions, have increased from the prior quarter as well as the total number of writers. These are positive indicators that give us confidence that our strategy and messaging are generating clarity and confidence in prescribing. Core to our strategy is driving prescriptions to our ArdelyxAssist in order to support patients and providers as they navigate the access landscape in this new environment.

與上一季相比，包括患者協助和付費處方在內的總配藥量以及開藥總人數均有所增加。這些都是正面的指標，讓我們相信我們的策略和訊息傳遞正在為處方帶來清晰度和信心。我們策略的核心是推動處方進入我們的 ArdelyxAssist，以支持患者和提供者在新環境中找到合適的就醫途徑。

During the second quarter, we saw growth in the percentage of prescriptions going through our ArdelyxAssist and a number of target HCPs who have had a patient successfully accessed XPHOZAH through ArdelyxAssist. Both are strong indicators that we are gaining momentum in this new environment.

在第二季度，我們看到透過 ArdelyxAssist 開出的處方比例有所增長，並且有越來越多的目標 HCP 的患者透過 ArdelyxAssist 成功獲得了 XPHOZAH。這兩個跡像都強烈表明，我們正在新環境中獲得發展動力。

We have grown the total number of paid prescriptions month over month since March, and we are focused on continuing that steady and consistent growth for the remainder of the year by generating greater depth and breadth in prescribing among XPHOZAH writers. To support patient access, we will continue to engage and partner with leadership teams and dialysis providers on ways to educate and support access to XPHOZAH.

自 3 月以來，我們的付費處方總數逐月成長，我們致力於在今年剩餘時間內繼續保持穩定、持續的成長，透過提高 XPHOZAH 執業醫師的處方深度和廣度。為了支持患者獲得治療，我們將繼續與領導團隊和透析提供者合作，以教育和支持患者獲得 XPHOZAH。

Finally, on patient pull-through, we will continue to support HCPs and patients in their prior authorization and pull-through needs. ArdelyxAssist plays an integral role regardless of payer, and we remain committed to patient access for the long term. As you can see, the XPHOZAH team is focused in the right areas, and we are delivering strong results. We know there continues to be a significant unmet need among patients with elevated phosphorus despite treatment with binders, and we seek to deliver on that opportunity. As such, we remain confident in our ability to achieve peak sales of $750 million.

最後，在患者延緩治療方面，我們將持續支持 HCP 和患者的事先授權和延緩治療需求。無論付款人是誰，ArdelyxAssist 都發揮著不可或缺的作用，我們始終致力於長期為患者提供醫療服務。如您所見，XPHOZAH 團隊專注於正確的領域，並且取得了強勁的成果。我們知道，儘管使用黏合劑治療，磷升高患者仍然存在大量未滿足的需求，我們尋求抓住這一機會。因此，我們仍然有信心實現 7.5 億美元的峰值銷售額。

It was a strong quarter for both IBSRELA and XPHOZAH. The team is focused and executing at the highest level, generating increased demand and improvements in patient pull-through. We are optimistic about the remainder of 2025, and we look forward to continued growth throughout the year.

對於 IBSRELA 和 XPHOZAH 來說，這是一個強勁的季度。團隊高度集中精力並以最高水準執行，從而增加了需求並改善了患者的治療效果。我們對 2025 年剩餘時間持樂觀態度，並期待全年繼續成長。

I will now turn it over to Justin. Justin?

現在我將把發言權交給賈斯汀。賈斯汀？

Thanks, Eric. Before jumping into the financials for the quarter, I want to take a moment to share my thoughts on leaving Ardelyx later this year. I have had the privilege of seeing the evolution of Ardelyx over the past five years. As many of you who have followed us for a long time now, there have been some challenges, but there have been many more successes.

謝謝，埃里克。在討論本季的財務狀況之前，我想花點時間分享我對今年稍後離開 Ardelyx 的想法。我有幸見證了 Ardelyx 過去五年的發展。正如許多長期關注我們的人一樣，我們遇到了一些挑戰，但也取得了更多的成功。

During my time at Ardelyx, I've had the opportunity to help launch two drugs, build the supply chain and support systems designed to ensure the product was always available for patients, navigate challenging financial markets and, what I'm most proud of, build the team capable and equipped to support the future operations for this company.

在 Ardelyx 任職期間，我有機會幫助推出兩種藥物，建立供應鏈和支持系統，以確保產品始終可供患者使用，應對充滿挑戰的金融市場，以及最讓我自豪的是，建立一支有能力和裝備支持該公司未來運營的團隊。

After establishing the infrastructure required to be a successful commercial company, Ardelyx is in a strong position, and it seems like the right time for me to make a transition. I look forward to staying on the help of the smooth transition of the finance leadership for the company. Ardelyx is a great company with an exciting future, and I look forward to continuing to follow the company's future successes after my departure.

在建立了成為成功的商業公司所需的基礎設施之後，Ardelyx 處於強勢地位，現在似乎是我轉型的最佳時機。我期待繼續幫助公司財務領導層的順利過渡。Ardelyx 是一家擁有令人興奮前景的偉大公司，我期待在我離開後繼續關注公司未來的成功。

Now on to the strong financial performance we delivered during the second quarter ended June 30, 2025. As Mike and Eric both shared, we generated significant patient demand during the second quarter. We have continued to thoughtfully invest in our business to support that growth and finished Q2 with improvement in net loss on a quarter-over-quarter basis. This performance reinforces our confidence in our ability to continue to generate significant revenue and carefully structure and manage our cost base.

現在來看看我們在截至 2025 年 6 月 30 日的第二季所取得的強勁財務業績。正如 Mike 和 Eric 所分享的，我們在第二季度產生了大量患者需求。我們繼續對我們的業務進行深思熟慮的投資以支持這一成長，並且在第二季結束時淨虧損較上一季有所改善。這項業績增強了我們對繼續創造可觀收入以及精心建構和管理成本基礎的能力的信心。

We shared our full financials in the press release and 8-K issued earlier today. I will not go into all of the individual items, but instead focus on the key drivers during the quarter, starting with revenue. For the period ended June 30, 2025, we reported total revenue of $97.7 million, an increase of 33% compared to the $73.2 million we reported in Q2 of last year. The growth was driven by significant increases in revenue by IBSRELA and product supply sales to our collaboration partners.

我們在今天早些時候發布的新聞稿和 8-K 中分享了我們的全部財務狀況。我不會深入討論所有個別項目，而是專注於本季度的關鍵驅動因素，首先是收入。截至 2025 年 6 月 30 日的期間，我們報告的總收入為 9,770 萬美元，與去年第二季報告的 7,320 萬美元相比增長了 33%。這一增長得益於 IBSRELA 的收入大幅增加以及我們合作夥伴的產品供應銷售。

During the second quarter of 2025, we recorded IBSRELA net product sales revenue of $65 million, an increase of 84% over the same period last year. IBSRELA has demonstrated consistent growth since launch and our strong performance in the second quarter was a reflection of the continued patient demand. We also saw an improvement in our gross to net deductions during Q2 compared to the first quarter due to decreased costs associated with our commercial co-pay program.

2025 年第二季度，我們記錄的 IBSRELA 淨產品銷售收入為 6,500 萬美元，比去年同期成長 84%。IBSRELA 自推出以來一直保持持續成長，我們在第二季度的強勁表現反映了持續的患者需求。由於與商業共同支付計劃相關的成本降低，我們第二季的總扣除額與淨扣除額與第一季相比也有所改善。

We finished the second quarter with a gross net deduction of approximately 32.2%. We expect IBSRELA to continue its strong performance for the remainder of 2025. And as such, we are raising our guidance and currently expect to finish the year with between $250 million and $260 million in net product sales revenue. We expect this growth to be driven by patient demand and improved prescription pull-through as well as modest improvements in our gross to net deduction.

我們第二季的淨扣除總額約為 32.2%。我們預計 IBSRELA 將在 2025 年剩餘時間內持續保持強勁表現。因此，我們提高了預期，目前預計今年的淨產品銷售收入將在 2.5 億美元至 2.6 億美元之間。我們預計這一增長將受到患者需求、處方藥使用率提高以及總扣除額與淨扣除額適度改善的推動。

XPHOZAH also had a very encouraging performance, recording $25 million in sales during the second quarter of 2025, which we delivered despite the loss of our largest payer, Medicare, compared to $37.1 million we recorded during the second quarter of last year.

XPHOZAH 的業績也非常令人鼓舞，2025 年第二季的銷售額達到 2,500 萬美元，儘管失去了最大的付款人 Medicare，但我們仍然實現了這一目標，而去年第二季的銷售額為 3,710 萬美元。

The $25 million for XPHOZAH we reported for Q2 reflects a 7% increase in net sales revenue from Q1 of 2025, driven by patient demand. As a reminder, our first-quarter XPHOZAH net sales revenue included a $3.8 million returns reserve release. Excluding the reserve release, we delivered a 27% increase in net sales revenue compared to Q1 of 2025. Our gross to net deduction was 29% for XPHOZAH, in line with our first-quarter gross to net of approximately 31% when one excludes the Q1 returns reserve release.

我們報告的 XPHOZAH 第二季銷售額為 2,500 萬美元，這反映了受病患需求推動，淨銷售收入較 2025 年第一季成長 7%。提醒一下，我們第一季 XPHOZAH 淨銷售收入包括 380 萬美元的退貨準備金。不包括儲備釋放，我們的淨銷售收入與 2025 年第一季相比成長了 27%。XPHOZAH 的毛淨扣除率為 29%，與第一季約 31% 的毛淨扣除率（不包括第一季的回報儲備釋放）一致。

Looking ahead, the signals we are seeing are very encouraging. The XPHOZAH strategy is working. We've established its place in the new market environment and the business is positioned for further growth in the second half of the year, driven by patient demand. In addition to product sales, we also recorded more than $6 million in product supply revenue related to sales to our international commercialization partners.

展望未來，我們看到的訊號非常令人鼓舞。XPHOZAH 策略正在發揮作用。我們已經在新的市場環境中站穩了腳跟，在患者需求的推動下，業務預計將在下半年進一步成長。除了產品銷售外，我們還記錄了與向國際商業化合作夥伴銷售相關的超過 600 萬美元的產品供應收入。

Now turning to expenses. R&D expenses were $15.7 million for the second quarter of 2025 compared to $12.8 million for the same quarter of the prior year. And SG&A expenses were in line with our expectations at $84 million compared to $64.7 million we reported in the second quarter of last year.

現在談談費用。2025 年第二季的研發費用為 1,570 萬美元，去年同期為 1,280 萬美元。銷售、一般及行政費用符合我們的預期，為 8,400 萬美元，而去年第二季我們報告的費用為 6,470 萬美元。

The increase in SG&A was related to our continued investment in commercial activities for IBSRELA and XPHOZAH, including the IBSRELA sales force expansion as well as growth of the overall corporate infrastructure to support our strategy. We expect our SG&A run rate to increase to approximately $90 million on a quarterly basis for the remainder of the year, with incremental increases each quarter.

銷售、一般及行政費用的增加與我們對 IBSRELA 和 XPHOZAH 商業活動的持續投資有關，包括 IBSRELA 銷售隊伍的擴張以及為支持我們的策略而增加的整體公司基礎設施。我們預計，今年剩餘時間內，銷售、一般及行政費用的季度運行率將增加至約 9,000 萬美元，每季都會逐步增加。

In the second quarter of 2025, we also had $11.7 million in noncash stock compensation expense and $2.2 million in noncash interest expense. I would also note that we satisfied our $75 million total royalty obligation to AstraZeneca during the second quarter. This obligation is now complete, and we've already seen an improvement to our gross margin since May.

2025 年第二季度，我們的非現金股票薪資支出為 1,170 萬美元，非現金利息支出為 220 萬美元。我還要指出的是，我們在第二季履行了對阿斯特捷利康總計 7,500 萬美元的特許權使用費義務。這項義務現已完成，自五月以來我們已經看到毛利率有所提高。

We had a net loss of approximately $19.1 million or $0.08 per share in the second quarter compared to a net loss of $16.5 million or $0.07 per share in the same period of last year. It should be noted that this is a significant improvement compared to the first quarter of 2025, when we reported a net loss of $41 million or $0.17 per share.

第二季我們的淨虧損約為 1,910 萬美元，即每股 0.08 美元，而去年同期的淨虧損為 1,650 萬美元，即每股 0.07 美元。值得注意的是，與 2025 年第一季相比，這是一個顯著的改善，當時我們報告的淨虧損為 4,100 萬美元，即每股 0.17 美元。

With respect to cash, we ended the second quarter with $238.5 million of cash, cash equivalents and short-term investments. This includes $48.7 million of incremental debt for our partners at SLR Capital. At a favorable interest rate of 8.7%, we believe this was a prudent opportunity to further strengthen our balance sheet and brings our current outstanding debt to $200 million with a blended interest rate of approximately 9.67% interest only through June 30, 2028. We also have the option for an additional $100 million in two $50 million tranches through next year.

就現金而言，我們第二季末的現金、現金等價物和短期投資為 2.385 億美元。其中包括為 SLR Capital 的合作夥伴提供的 4,870 萬美元增量債務。在 8.7% 的優惠利率下，我們認為這是一個進一步加強資產負債表的謹慎機會，並將使我們目前的未償債務達到 2 億美元，截至 2028 年 6 月 30 日的混合利率約為 9.67%。我們也可以選擇在明年分兩次各 5,000 萬美元的金額再投入 1 億美元。

We believe that the performance in the second quarter demonstrates our commitment to growing the top line while focusing on the bottom line. We remain committed to achieving the peak net sales revenue opportunities that we see for both of our commercial products totaling more than $1.75 billion, thoughtfully investing in our business and maximizing shareholder value.

我們相信，第二季的業績反映了我們致力於增加營業收入的同時也注重獲利。我們將繼續致力於實現我們兩種商業產品的淨銷售收入高峰機會，總額超過 17.5 億美元，精心投資於我們的業務並最大化股東價值。

And 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, Eric, and thank you, Justin. I hope that what you've taken away from our call today is that the performance is an indication of what you can expect from us: a focus on execution, continued momentum and delivering on our priorities. I'd like to say a note of thanks to everyone on team Ardelyx for your hard work and commitment to bring our important medicines to patients. Thank you also to our shareholders for your continued trust and support.

謝謝，艾瑞克，謝謝你，賈斯汀。我希望您從我們今天的電話會議中了解到，我們的表現表明了您對我們的期望：專注於執行、保持動力並實現我們的優先事項。我想向 Ardelyx 團隊的每一個人表示感謝，感謝你們的辛勤工作和承諾，為患者帶來我們的重要藥物。也感謝我們的股東一直以來的信任與支持。

I will now turn the call to questions. Ellis?

我現在開始提問。艾利斯？

(Operator Instructions) Louise Chen, Scotiabank.

（操作員指示）Louise Chen，豐業銀行。

Hi, congratulations on the quarter. Thanks for taking my question here. I had two for you. Number one, I wanted to ask you if there was any update on a potential EU partner? And then secondly, I wanted to ask you how you're thinking about getting to cash flow positive? Is it a near-term or medium-term goal for you? Thank you.

嗨，恭喜本季。感謝您在這裡回答我的問題。我幫你準備了兩份。首先，我想問一下，關於歐盟潛在合作夥伴，是否有任何最新消息？其次，我想問您如何考慮實現現金流為正？對您來說，這是一個近期目標還是中期目標？謝謝。

Hi, Louise, how are you? Listen, second part of your questions first is, obviously, we always look at cash flow breakeven and free cash flow in order to reinvest in the business. That's clearly an important thing. I think you can do the math within the guidance that we've given and see that it's not that far off on the horizon.

嗨，路易絲，你好嗎？聽著，你問題的第二部分首先是，顯然，我們總是專注於現金流損益平衡和自由現金流，以便對業務進行再投資。這顯然是一件重要的事情。我認為，您可以根據我們提供的指導進行計算，並發現它距離目標並不遙遠。

In terms of EU, we're going to continue to evaluate opportunities. If you look at both of these businesses as it relates to Europe, and let's not even think about the halo -- negative halo of MFN over making those decisions, there's nothing really substantive to talk about in terms of those opportunities at this stage.

就歐盟而言，我們將繼續評估機會。如果你把這兩項業務都與歐洲聯繫起來看，我們甚至不要考慮最惠國待遇對做出這些決定帶來的負面影響，那麼就這些機會而言，現階段還沒有什麼實質性的東西可談。

Dennis Ding, Jefferies & Company.

丹尼斯丁，傑富瑞公司。

I have two, if I may. One is on IBSRELA. So talk about the new guidance and what's factored into that? It seems a little bit conservative given the demand in scripts that we're seeing and also the fact that $8 million of that $10 million raise came from the Q2 [beat]. So I'm wondering if there's anything that we are not thinking about, but you're seeing on the ground?

如果可以的話，我有兩個。一個是關於 IBSRELA 的。那麼，請談談新的指導方針以及其中考慮的因素是什麼？考慮到我們看到的劇本需求，以及 1000 萬美元融資中的 800 萬美元來自第二季度，這個數字似乎有點保守。所以我想知道是否有一些我們沒有想到但您親眼看到的事情？

And then my second question is on XPHOZAH. Can you remind us what the gross to net was in Q2? I think you may have said 29%, which is surprising given that's better than Q1, but you are booking only commercial and Medicaid revenue in Q2, which have worse gross to net than Medicare. So how are you thinking about gross to net for the second half of the year for IBSRELA?

我的第二個問題是關於 XPHOZAH 的。您能提醒我們第二季的毛利率與淨利率是多少嗎？我認為您可能說過 29%，考慮到這比第一季要好，這是令人驚訝的，但您在第二季度只記錄了商業和醫療補助收入，而這兩個季度的毛收入與淨收入之比比醫療保險要差。那麼您如何看待 IBSRELA 下半年的毛利率與淨利率？

IBSRELA. Sure. I'll have Justin address that. Sure. Thank you, Dennis, for the questions. I'll have Justin address the second in a minute. With the first, you should know us well enough by now that when we give numbers, we are thoughtful and deliberate about what we say. Nothing to read into this, except that that $10 million increase in our guidance is a meaningful step in the right direction of what this opportunity is.

IBSRELA。當然。我會讓賈斯汀解決這個問題。當然。謝謝丹尼斯提出的問題。我會讓賈斯汀馬上解決第二個問題。首先，您現在應該足夠了解我們了，當我們給出數字時，我們會經過深思熟慮並慎重考慮。對此沒什麼好解讀的，只是我們的指導金額增加了 1000 萬美元，這是朝著這個機會的正確方向邁出的重要一步。

And I think should put little doubt in people's minds about our long-term projections, the opportunity for this business. So I would focus on that. And with opportunity to give you more perspective on how we believe this year will play out, we certainly will provide that.

我認為人們應該對我們的長期預測和這項業務的機會毫不懷疑。所以我會集中精力於此。我們一定會為您提供更多有關我們認為今年將如何發展的視角。

Justin, do you want to provide some perspective on Q2 gross to net?

賈斯汀，你想對第二季的毛利率和淨利率提供一些看法嗎？

Thanks, Dennis. So you're correct. In Q1, when one excludes that onetime returns reserve release we did, our gross net would have been approximately 31%, and for Q2, it was approximately 29%. It does pertain to product mix, right patient mix and who the payer is. So those are pretty close to each other. There's really mild differences. We did have an improvement in commercial co-pay, that was the primary driver. Again, co-pay for both of our products typically improves over the course of the year.

謝謝，丹尼斯。所以你是對的。在第一季度，如果不包括我們一次性釋放的回報儲備，我們的總淨利潤約為 31%，而在第二季度，這一數字約為 29%。它確實涉及產品組合、正確的患者組合以及付款人是誰。所以它們彼此非常接近。確實存在細微的差別。我們在商業共同支付方面確實有所改善，這是主要驅動力。再次，我們兩種產品的共同支付通常在一年內會有所改善。

Many of our patients are on what I call calendar year health care plans. So if they're commercial patients, they may have a higher deduct from the beginning part of the year and improves for them as a patient over time. So the primary difference between Q1 and Q2 is on the amount of commercial co-pay that we need to, again, help the patient-to-patient assistance. I would look for it to be in that 30% range in general for the rest of this year. Again, 29% to 31% is a reasonable range. And we're still working in a new environment. There might be minor changes here and there, but I expect it to be in that general range.

我們的許多患者都參與了我所說的日曆年醫療保健計劃。因此，如果他們是商業患者，他們可能從年初開始獲得更高的扣除額，並且隨著時間的推移，他們作為患者的扣除額會有所提高。因此，Q1 和 Q2 之間的主要區別在於我們需要的商業共同支付金額，以再次幫助患者對患者的援助。我預計今年剩餘時間內該數字將總體上維持在 30% 左右。再次強調，29%到31%是合理的範圍。我們仍在新的環境中工作。這裡或那裡可能會有細微的變化，但我預計它會在大致範圍內。

Ryan Deschner, Raymond James.

瑞安‧德施納、雷蒙‧詹姆斯。

Congrats on the quarter. I'm curious how much of -- this quarter's IBSRELA sales growth, do you attribute to expanded sales team now that it's firing on all cylinders and you've got three full quarters in? Do you expect continued meaningful pull-through acceleration into 2026 due to this expanded field team? Or will that start to taper off around that time? Thanks.

恭喜本季取得佳績。我很好奇，本季 IBSRELA 的銷售成長有多少是歸功於擴大的銷售團隊，因為現在銷售團隊正全力以赴，而且已經過去了整整三個季度？您是否預計，由於現場團隊的擴大，到 2026 年，拉動成長將繼續顯著加速？或者到那時這種情況會開始逐漸減少？謝謝。

Thanks for the question, Ryan. Let me ask Eric to address that. And certainly, it's not only on the sales side with the APDs, but the field access managers that Eric has spoken on that you can address that, too.

謝謝你的提問，Ryan。讓我請埃里克來解決這個問題。當然，這不僅是 APD 的銷售方面，而且 Eric 提到的現場訪問經理也可以解決這個問題。

Yeah. Thanks, Ryan, for the question. As I said in my earlier comments, we're three full quarters post completion of the expansion. So obviously, with increased call activity, we're seeing significant increase in terms of number of writers leading to increase in new and refill prescriptions. We expect that to continue.

是的。謝謝 Ryan 提出這個問題。正如我在先前的評論中所說，我們已經完成了擴建的整整三個季度。因此，顯然，隨著呼叫活動的增加，我們看到寫藥者的數量顯著增加，從而導致新處方和續處方增加。我們預計這種情況將會持續下去。

Just to remind you, I mean, there's significant opportunity in this market. Only a quarter of patients we know are satisfied in this large market with -- being on therapy with the secretagogue. So we feel very confident in the opportunity that's in front of us. With this increased activity, we certainly expect it to continue for the remainder of the year.

只是想提醒你，這個市場存在著巨大的機會。據我們所知，在這個龐大的市場中，只有四分之一的患者對使用促泌劑進行治療感到滿意。因此，我們對眼前的機會充滿信心。隨著活動的增加，我們當然預計這種情況將在今年剩餘時間內持續下去。

Thank you very much. And just a quick follow up. Just wanted to see how you're thinking about one quarter sort of seasonality going forward, how we should think about that over the next few years. Thanks.

非常感謝。並進行快速跟進。只是想看看您如何看待未來一個季度的季節性，以及我們應該如何看待未來幾年的季節性。謝謝。

Sure. I'll ask Eric to provide some more perspective on it. But I think as we spoke about in the first quarter, it's the first time we saw it in the way that we did. And as this business grows and the magnitude of that impact is there, I think it's something that's prudent to have in there. Eric?

當然。我會請 Eric 對此提供更多的看法。但我認為，正如我們在第一季談到的那樣，這是我們第一次以這種方式看待它。隨著業務的成長和影響的擴大，我認為將其納入其中是明智之舉。艾瑞克？

Yeah. Like I said, we're very confident in our results at this point. We want to make sure we're mindful of the summer months, and we don't get ahead of ourselves. So really confident about our performance at this point in the year and certainly look forward to being able to move into back half of this year. We know that primarily, we do see that seasonality in Q1.

是的。正如我所說的，我們對目前的結果非常有信心。我們要確保自己留意夏季的幾個月，並且不要操之過急。因此，我們對今年此時的表現非常有信心，並且非常期待能夠進入今年下半年。我們知道，首先，我們確實在第一季看到了季節性。

I think for us, as we move into the back half of this year, it's more just being -- making sure that we're recognizing what's going on during the summer months where you have more vacations, physicians are taking vacations, patients are taking vacations. You've got return to school that happens in August.

我認為，對我們來說，隨著我們進入今年下半年，更重要的是——確保我們了解夏季發生的事情，因為夏季有更多的假期，醫生正在休假，病人正在休假。你將於八月返校。

And then really things start to pick back up towards the end of the quarter as they move into fourth quarter. So for us, we're very confident of things at this point in time. We'll be mindful of those events as we go through this quarter and feel really confident about how we're going to be able to finish things up.

然後，隨著進入第四季度，情況在本季末開始回升。因此，對我們來說，目前我們對事情非常有信心。在本季中，我們會留意這些事件，並對如何完成任務充滿信心。

Julian Harrison, BTIG.

朱利安·哈里森（Julian Harrison），BTIG。

Hi, congrats on the quarter and thanks for taking the questions. On XPHOZAH, apologies if I missed it. Wondering if there was any contribution from transitional scripts in 2Q? Or are we completely past that now? And then on IBSRELA, do you have any sense for how uptake in the first-line setting is trending? Are you seeing any traction there? Did you promote use at all in that setting? Or is that something typically just happening on its own right now?

您好，恭喜本季取得佳績，感謝您回答問題。在 XPHOZAH 上，如果我錯過了，請見諒。想知道第二季度過渡腳本是否有任何貢獻？或者我們現在已經完全過去了？那麼關於 IBSRELA，您是否了解第一線治療的吸收趨勢如何？您看到那裡有任何吸引力嗎？在那種環境下您是否提倡使用？或者這只是現在自然發生的事情？

Sure. Let me address the first part of your question on IBSRELA to transition scripts. There was an inconsequential amount there and how long that lasts. That's something we're not really taking a whole lot of stance on. So generally, it's about 50-50 and the overall mix between Medicaid and commercial is the way to think about it.

當然。讓我來回答您關於 IBSRELA 過渡腳本的問題的第一部分。那裡有一個無關緊要的數額，並且持續了多長時間。我們對此並沒有採取太多立場。所以一般來說，比例大約是 50-50，而醫療補助和商業之間的整體組合就是思考的方式。

In terms of first-line therapy --

就一線治療而言--

Yeah. Good question. Thank you for that, Julian. Yeah. First-line therapy, certainly, we are aware of some of that. I think as you look at our positioning kind of post use with a secretagogue and having significant opportunity there, we feel very confident in our positioning there. I think as physicians continue to get confident in IBSRELA and the impact that it can have for patients, certainly, they may go to that earlier than what they're used to going -- they're used to going to.

是的。好問題。謝謝你，朱利安。是的。一線治療，當然，我們知道其中的一些。我認為，當您看到我們與分泌者合作的定位類型崗位使用情況以及在那裡的重大機會時，我們對我們的定位非常有信心。我認為，隨著醫生對 IBSRELA 及其對患者的影響越來越有信心，他們當然可能會比以前更早開始使用 IBSRELA — — 他們習慣於這樣做。

And it is important to note, our indication is for first-line use. So it's more than appropriate for physicians to go to that first line. And for us, it's about making sure that we have patient access. So if they're able to get it first line and they have confidence in the product for the patient, and it's the right choice, they should be able to get it. If it's post use for the secretagogue, again, we've got focus there on patient pull-through and very confident in the improvements that we're seeing there and expect that to continue for the remainder of the year.

值得注意的是，我們的適應症是用於第一線用途。因此，醫生前往第一線是再合適不過的了。對我們來說，這是為了確保患者能夠獲得治療。因此，如果他們能夠首先獲得該產品，並且對該產品對患者有信心，並且這是正確的選擇，那麼他們就應該能夠獲得它。如果是促分泌劑的後期使用，我們再次將重點放在患者的康復上，並對我們所看到的改善非常有信心，並預計這種情況將在今年剩餘時間內持續下去。

Okay. Excellent. Thank you and congrats again.

好的。出色的。再次感謝並恭喜你。

Joseph Thome, TD Cowan.

約瑟夫·托米 (Joseph Thome)，考恩 (Cowan) TD。

Congrats on the progress and best wishes to Justin on his next steps. Maybe on the pull down of the $50 million. Can you go into a little bit more detail as to what triggered that outside of the favorable interest rate dynamics? And maybe when you think about that remaining $100 million, what would be sort of the triggers to pull the reps down? Obviously, you instituted the new CMO. Should we be thinking about this as sort of opportunistic BD or kind of building up the pipeline at all? Or kind of what would you be using this cash for? Thank you.

恭喜賈斯汀的進步，並祝他接下來一切順利。也許是 5000 萬美元的縮水。除了有利的利率動態之外，您能否更詳細地說明引發這現象的因素是什麼？也許當您考慮剩下的 1 億美元時，什麼因素會降低代表的聲譽？顯然，您設立了新的 CMO。我們是否應該將此視為一種機會主義的 BD 或一種管道建設？還是你會用這筆現金做什麼？謝謝。

Just a quick comment, and then I'll ask Justin to mention. SLR [solar] has been a phenomenal partner of ours. And with the opportunity to get this, it's something that just made sense to strengthen the balance sheet, as I said in my opening comments.

只是一個簡短的評論，然後我會請賈斯汀提及。SLR [solar] 一直是我們優秀的合作夥伴。正如我在開場白中所說的那樣，有了這樣的機會，加強資產負債表就變得有意義了。

Justin, anything [you'd like to] add?

賈斯汀，你還有什麼要補充的嗎？

Yeah. Thanks, Mike, and thanks, Joe. Again, hopefully, you've seen, over time, we try to be very thoughtful and strategic with any of our fundraising initiatives, debt equity and otherwise. So cost of capital is always important to us and be mindful of our shareholders. The debt presented itself at a very favorable interest rate.

是的。謝謝麥克，也謝謝喬。希望你們已經看到，一直以來，我們都會非常周到地、有策略地對待我們的任何融資計劃，包括債務股權融資等等。因此，資本成本對我們來說始終很重要，我們要時時關注我們的股東。這筆債務的利率非常優惠。

And so we thought it was a prudent opportunity for us to take advantage of that and give us some near-term flexibility. So looking ahead, again, it's always important for us to have optionality for our team. So we will never do anything just to do anything, but it's nice to have that flexibility and optionality going forward.

因此，我們認為這是一個謹慎的機會，我們可以利用這一點並為我們提供一些短期靈活性。因此，展望未來，為我們的團隊提供選擇權對我們來說始終很重要。因此，我們絕不會為了做某事而做某事，但未來擁有這種靈活性和可選性是件好事。

And maybe just one more, if I may. Do you think that both of the sales teams are now rightsized to meet your peak guidance that you've set out for both XPHOZAH and IBSRELA? Or when is the right time to reassess if you're at the right time? Thank you.

如果可以的話，也許我還可以再說一個。您是否認為這兩個銷售團隊現在都已達到您為 XPHOZAH 和 IBSRELA 設定的峰值指引？或是什麼時候才是重新評估自己是否處於正確時機的最佳時機？謝謝。

Yeah. Just one quick one for me and I'll ask Eric to step in is we are always assessing how best to optimize our footprint and what we're doing. So that should never stop. I think we are pretty confident in terms of where we are in right size.

是的。我只想快速說一句，我會請 Eric 介入，我們一直在評估如何最好地優化我們的足跡和我們正在做的事情。所以這永遠不應該停止。我認為我們對於自己的合適規模非常有信心。

But Eric, anything to add?

但 Eric，還有什麼要補充的嗎？

Yeah. Thanks, Joe. Yeah, pretty confident in terms of where we are with IBSRELA. Just a reminder, we're coming off our three highest quarters of demand. So we feel like the team is really hitting their stride in addition to the expansion of build access manager. So focusing on improvements in the middle of the funnel to be able to improve access. So I think right now, as we look at the sizing of our teams, we feel very confident where it is.

是的。謝謝，喬。是的，我們對 IBSRELA 的現況很有信心。提醒一下，我們剛剛經歷了需求最高的三個季度。因此，我們覺得除了擴展建置存取管理器之外，團隊確實正在取得進展。因此，重點關注漏斗中間的改進，以便能夠提高訪問量。所以我認為現在，當我們審視我們團隊的規模時，我們感到非常有信心。

To Mike's point, we are always assessing to look for opportunities to be able to drive incremental demand. But we also have our marketing activities that are out there. As I mentioned earlier, highly impactful marketing activities that supplement the field force activity, right, that's out there.

正如麥克所說，我們一直在評估尋找能夠推動增量需求的機會。但我們也開展了行銷活動。正如我之前提到的，具有高度影響力的行銷活動可以補充現場活動，對的，這就是存在的。

On the XPHOZAH side, as we said since the beginning of the year, it's about patient access and physicians now differentiate between Medicare or non-Medicare segments. And so we're focused on the same number of nephrologists that we were focused on last year. And as you can see by some of the numbers and the improvements in the demand indicators from Q1 to Q2, certainly feel like their efforts are appropriate and having impact to those physicians that we're targeting. And so right now, I feel really good about the sizing that we have for that team as well.

在 XPHOZAH 方面，正如我們今年年初所說的那樣，這關乎患者的就醫機會，醫生現在區分醫療保險和非醫療保險部分。因此，我們關注的腎臟病專家數量與去年相同。從第一季到第二季的一些數字和需求指標的改善可以看出，他們的努力是適當的，並且對我們所針對的醫生產生了影響。所以現在，我對我們為該團隊所製定的規模感到非常滿意。

Yigal, Citigroup.

花旗集團的伊加爾。

Hi, this is [Johan joining in] for Yigal. Congrats on the quarter and thanks for taking my question. Maybe just two quick ones from us. We were wondering if there's any color at all you can provide on the breakdown of new patients versus refills and prescriptions for IBSRELA?

大家好，我是 Yigal 的 [Johan]。恭喜本季取得佳績，感謝您回答我的問題。也許我們只想快速回答兩個問題。我們想知道您是否可以提供關於 IBSRELA 新患者與續藥和處方的詳細情況？

Yeah, we've not historically given a whole lot of detail around that. I think as you heard in Eric's comments, we have seen a good amount of increase in refill, which is exactly [what these] these patients be sticky and with the benefit of these medicines are providing. So we like to see that trend. I mean, the specifics we have not historically given those details.

是的，我們過去並沒有提供過有關這方面的詳細資料。我想正如你在 Eric 的評論中聽到的那樣，我們已經看到補充量大幅增加，這正是這些患者堅持服用這些藥物並從中受益的原因。所以我們喜歡看到這種趨勢。我的意思是，我們過去並沒有提供過這些具體細節。

Anything to add?

還有什麼要補充的嗎？

No. Nothing more to add there, just about making sure that the patient is going to the right channel to be able to get the product. And with that, we saw more refills this quarter than we have seen in the past, certainly versus new prescriptions. And that, again, is just another indicator that gives us confidence in terms of what we're able to achieve with IBSRELA.

不。沒有什麼可補充的，只需確保患者透過正確的管道獲得產品。因此，本季我們看到的續藥量比過去要多，當然與新處方量相比也是如此。而這再次表明，我們對 IBSRELA 所能取得的成就充滿信心。

Got you. Very encouraging. And if I may, just one more question. Is there any update -- or what is the latest update in terms of the ongoing CMS legal proceedings?

明白了。非常令人鼓舞。如果可以的話，我還有一個問題。有任何更新嗎——或者正在進行的 CMS 法律訴訟方面的最新進展是什麼？

Yeah. I mean, as you can imagine, we've gotten out of the business of trying to predict the administration and government, but we have -- our case will be -- arguments will be September 25. There's no statutory requirement for when we get a response back. And as soon as we know anything of substance, we certainly will provide that for all of you.

是的。我的意思是，正如你所想像的，我們不再試圖預測政府和政府的行動，但我們的辯論將在 9 月 25 日進行。對於我們何時收到回复，沒有法定要求。一旦我們知道任何實質性的信息，我們一定會向大家提供。

Great. Congrats on the quarter again, and thanks so much.

偉大的。再次恭喜本季取得佳績，非常感謝。

Laura Chico, Wedbush Securities.

勞拉‧奇科 (Laura Chico)，韋德布希證券公司。

I've got to start out with a shout-out to Justin. Best of luck, Justin. Sorry to see you leaving. But congrats on the quarter. And I guess one on XPHOZAH. Now there's been a couple of quarters in the new reimbursement environment. Just wondering, Mike, if you can recalibrate it for us and just tell us what gives you confidence in the new peak estimate for XPHOZAH that you're seeing now in this reimbursement environment. And when will you be in a position to restore guidance for XPHOZAH? Thanks very much.

首先我要向賈斯汀致敬。祝你好運，賈斯汀。很遺憾看到你離開。但還是要祝賀本季。我猜 XPHOZAH 上有一個。現在新的報銷環境已經持續了幾個季度。只是想知道，麥克，你是否可以為我們重新校準它，並告訴我們是什麼讓你對現在在這個報銷環境中看到的 XPHOZAH 的新峰值估計值有信心。您什麼時候能夠恢復對 XPHOZAH 的指導？非常感謝。

Yeah. Thanks for the question, Laura. And thank you for the shout-out to Justin. Clearly, that is well earned and appropriate. In terms of guidance for XPHOZAH, we will provide it. As we said in our comments, we saw a month-over-month growth since March, and I would like a little bit more consistency before we get out there with numbers for you.

是的。謝謝你的提問，勞拉。感謝您對賈斯汀的稱讚。顯然，這是當之無愧且恰當的。關於 XPHOZAH 的指導，我們將提供。正如我們在評論中所說，自 3 月以來，我們看到了月度環比增長，在我們向您提供數字之前，我希望看到更多的一致性。

As you can imagine, we continue to be thoughtful about what we say and when we say it. For me, that question that you asked at the beginning in terms of what gives me confidence is with a total available market of 220,000 patients, which is basically what we are now, given that's the non-Medicare segment, the math is pretty straightforward.

正如您所想的，我們會繼續認真考慮我們說什麼以及何時說話。對我來說，您一開始就提出的那個讓我有信心的問題是，總可用市場有 220,000 名患者，這基本上就是我們現在的情況，考慮到這是非醫療保險部分，數學計算非常簡單。

As you look at our guidance of $750 million with a number of scripts, if you use binder script refills, you would use our WACC with modest price increases over time, it's substantively less than 100,000 patients that gets you to that $750 million. So I've got great confidence in this trajectory and the performance that we're seeing here and our commitment to the patients. I have great faith in the XPHOZAH team and, Eric, the pull-through work that the [fans] are doing across the board, marketing efforts, the entire XPHOZAH team is focused on what's doing right for these patients. And as a result, we at large have great confidence in that number that we provided.

當您看到我們對 7.5 億美元的指導以及大量處方時，如果您使用活頁夾處方補充，您將使用我們的 WACC，並且隨著時間的推移價格會適度上漲，那麼實際上只需不到 100,000 名患者就能達到 7.5 億美元。因此，我對這一軌跡、我們在這裡看到的表現以及我們對患者的承諾充滿信心。我對 XPHOZAH 團隊和 Eric 充滿信心，[粉絲] 正在全力以赴地進行行銷工作，整個 XPHOZAH 團隊都專注於為這些患者做正確的事情。因此，我們對所提供的數字總體上非常有信心。

That's helpful, Mike. And maybe just one last one. On IBSRELA, I don't know if you'll be able to answer this, but what is the average duration on treatment now for a patient there? Thanks very much, guys.

這很有幫助，麥克。也許這只是最後一個。關於 IBSRELA，我不知道您是否能夠回答這個問題，但是現在那裡的患者接受治療的平均時間是多久？非常感謝大家。

Sure. I mean, I think the average duration for IBS-C scripts is about five. We're trending the same, if not a little bit better. So I feel very good about the refill rates that we're seeing here just given this tends to be a disease of -- the experience the patients have is somewhat [waxing, remitting] and that has been historically case, and we'll see if that is the case with us or if it's a tachyphylaxis you see with the GCC agonist. That's the sort of thing that we pay close attention to.

當然。我的意思是，我認為 IBS-C 腳本的平均持續時間約為五分鐘。我們的趨勢是一樣的，甚至更好一點。因此，我對我們在這裡看到的補充率感到非常滿意，因為這往往是一種疾病 - 患者的經歷在某種程度上是[加劇，緩解]，並且這是歷史上的情況，我們將看看我們的情況是否如此，或者這是否是 GCC 激動劑的快速耐受性。這是我們密切關注的事情。

Prakhar Agrawal, Cantor Fitzgerald.

普拉哈·阿格拉沃爾，坎托·菲茨杰拉德。

Congrats on the quarter. So first, on IBSRELA, you commented on typical summer seasonality, but it seems like the 3Q script trends are also being good. So maybe just comment on how do you see IBSRELA trends for the rest of the year and just the market overall? If you look at some of the prior year trends, second half in aggregate tends to be much stronger than first half. So should this year be any different? And just had a quick follow-up.

恭喜本季取得佳績。首先，關於 IBSRELA，您評論了典型的夏季季節性，但似乎第三季的劇本趨勢也很好。那麼，也許您只是評論一下您如何看待今年剩餘時間的 IBSRELA 趨勢以及整個市場？如果你看一下前幾年的一些趨勢，你會發現下半年整體上比上半年強勁得多。那麼今年會有什麼不同嗎？並進行了快速跟進。

Yeah, Prakhar, thank you for the question. As I said at the start, with the first question I got was, what do we think about this [$250 million to $260 million] compared to performance and exactly what you just described. With an opportunity to provide you more perspective as we go through the rest of the year, we certainly will do that. This is a meaningful step for us to give a $10 million increase in our guidance. We haven't done that before in this way. So we are going to take mindful and thoughtful steps as we see the performance show itself. And the data that you look at historically that you just described, sure, I can't argue against that. And we will provide more perspective as we can going forward.

是的，Prakhar，謝謝你的提問。正如我在開始時所說的那樣，我收到的第一個問題是，與業績和您剛才的描述相比，我們對這筆錢（2.5 億到 2.6 億美元）有何看法？在接下來的一年裡，我們有機會為您提供更多的觀點，我們一定會這樣做。對我們來說，將指導金額提高 1000 萬美元是一個有意義的舉措。我們以前沒有以這種方式做過這件事。因此，當我們看到表演本身時，我們將採取謹慎而周到的措施。當然，對於您剛才描述的歷史數據，我無法反駁。我們將盡可能提供更多的觀點。

Thank you. And on XPHOZAH, I realize you're not providing the guidance, but consensus is sitting at $99 million for the full year. So maybe just if you could comment on your comfort on where the Street estimates are for XPHOZAH for the full year? And would you expect sequential quarterly growth for XPHOZAH for the rest of the year? Thank you.

謝謝。關於 XPHOZAH，我知道您沒有提供指導，但大家一致認為全年預算為 9900 萬美元。那麼，您是否可以評論一下，您對 XPHOZAH 全年的市場預期是否滿意？您預計 XPHOZAH 在今年剩餘時間內將實現季度連續成長嗎？謝謝。

Yeah, nice question. You cornered me into giving you guidance. But I won't bite on all of it. What I will bite on is we just scored a $25 million quarter that we've said is based upon true real demand on the non-Medicare population. And do the math, if it was flat and not much gets us to exactly the kind of modest growth that you would need. So I feel very good about the trajectory that we're on.

是的，好問題。你逼我給你指導。但我不會全部接受。我要強調的是，我們剛剛實現了 2500 萬美元的季度收入，我們表示這是基於非醫療保險人口的真正需求。算一算，如果它持平並且沒有什麼能讓我們達到我們所需要的那種適度增長。所以我對我們的發展軌跡感到非常滿意。

And I feel confident that we will, in the not-too-distant future, be able to provide you some guidance. With growth since March, I am going to be thoughtful about doing that because I don't want to get ahead of myself or any of us ahead of our skis and what we're trying to do. So that's why we're sticking to our guns and not providing guidance yet, but we will.

我相信，在不久的將來，我們將能夠為您提供一些指導。自從三月以來，隨著業務的成長，我會認真考慮這樣做，因為我不想超越自己或任何人，超越我們的滑雪板和我們正在嘗試做的事情。所以這就是為什麼我們堅持自己的立場並且暫時不提供指導，但我們會提供的。

Aydin Huseynov, Ladenburg Thalmann.

艾丁‧侯賽諾夫，拉登堡‧塔爾曼。

Congratulations with a strong quarter, actually a record quarter for IBSRELA, I think. So let me ask a general question first. So you're now like almost on track to generate $400 million a year and you only traded at $1 billion valuation. So one can imagine that you might be pushed by larger players. And if you do, where do you see the potential acquirers interest more? In GI space or on the renal space? And this is obviously a very hypothetical question, but do you think you are valid more on GI or on the renal side? Thank you.

恭喜您本季業績強勁，我認為對於 IBSRELA 來說這實際上是一個創紀錄的季度。因此，我首先要問一個一般性的問題。所以，您現在幾乎有望實現每年 4 億美元的收入，但您的估值僅為 10 億美元。因此可以想像，你可能會被更強大的玩家所推動。如果您這樣做，您認為潛在收購者對哪些方面更感興趣？在胃腸道還是腎臟空間？這顯然是一個非常假設性的問題，但您認為您對胃腸道還是腎臟的回答更有效？謝謝。

You guys are the sell side. You tell me. I clearly think we're undervalued on both sides of the equation. Whether $750 million peak for XPHOZAH or $1 billion or more on IBSRELA, we're undervalued. And whether it's because people find -- show me story for XPHOZAH, and I think we're showing everyone, or that IBSRELA in the GI market is hard to understand. I can't understand that because it's pretty straightforward with what we're doing in our performance.

你們是賣方。你告訴我。我顯然認為我們在等式的兩邊都被低估了。無論 XPHOZAH 的峰值為 7.5 億美元，還是 IBSRELA 的峰值為 10 億美元或更多，我們都被低估了。是因為人們發現——給我看 XPHOZAH 的故事，我想我們正在向所有人展示，或者 GI 市場上的 IBSRELA 很難理解。我無法理解這一點，因為這與我們在表演中所做的事情非常直接相關。

So our objective here is to build a great company and a sustainable enterprise. And I'm less interested in how other people think of us in terms of bigger companies out there versus ultimately the patients that we're here to serve.

因此，我們的目標是建立一家偉大的公司和一個可持續發展的企業。我不太關心別人如何看待我們，只關心我們是外面的大公司，更關心我們最終服務的對像是病人。

Allison Bratzel, Piper Sandler.

艾莉森‧布拉澤爾，派珀‧桑德勒。

Hi. This is Ashley on for Allison. Congrats on a great quarter, guys. I just had two questions. One for XPHOZAH. I know this is already asked in terms of guidance, but if there's anything that you can point us to in terms of what you're hoping to see in terms of any specific metrics or indicators that would give you the confidence to provide guidance maybe in the second half of the year? That would be really helpful.

你好。這是艾希莉 (Ashley) 代替艾莉森 (Allison)。各位，恭喜你們取得了出色的季度業績。我只有兩個問題。一個是 XPHOZAH。我知道這已經是在指導方面提出的問題了，但是您是否可以向我們指出您希望看到的任何具體指標或指標，這些指標會讓您有信心在下半年提供指導？那將會非常有幫助。

And then second, on your licensing revenue and tax supply revenue and noncash royalty revenue from your partners, we're seeing some really good growth on that front. So just wondering what that could look like in the second half of the year or if you have any expectations. Thanks.

其次，關於您的授權收入、稅收收入以及來自合作夥伴的非現金特許權使用費收入，我們看到了非常好的成長。所以我只是想想知道下半年的情況會是什麼樣子，或者您是否有什麼期望。謝謝。

Sure. Justin will address the second question in a minute. For your first one, it's frankly more of the same right? If you look at what we've done, Q1 without peculiarities we saw there and uncertainties that people had. I think what we've shown everyone in Q2 is they trust us, our strategy is right and we're serving these patients who really need better phosphorus control. So I think that's unequivocal.

當然。賈斯汀將在一分鐘內回答第二個問題。對於您的第一個，坦白說，它與第一個大同小異，對嗎？如果你看看我們所做的事情，你會發現第一季並沒有出現我們所看到的特殊情況以及人們所存在的不確定性。我認為我們在第二季度向所有人展示的是他們信任我們，我們的策略是正確的，我們正在為真正需要更好地控制磷的患者提供服務。所以我認為這是毫無疑問的。

I'm thoughtful we are conservative and mindful of the way we give guidance. And I think it's [seen] more of the same, honestly, as we navigate this quarter and into next to gain the confidence to provide you some guidance.

我認為我們是保守的，並且注意我們提供指導的方式。老實說，我認為，隨著我們在本季度和下一季取得進展，我們將有信心為您提供一些指導，這種情況將繼續發生。

Justin?

賈斯汀？

Yes. Thank you. So we do generate product supply revenue from our three international collaborative partners. We did have a good second quarter, as you noted, just over $6 million. So our partners ordered from us quasi regularly, but not quarterly.

是的。謝謝。因此，我們確實從我們的三個國際合作夥伴那裡獲得了產品供應收入。正如您所說，我們的第二季業績確實不錯，收入略高於 600 萬美元。因此，我們的合作夥伴定期向我們訂購，但不是按季度訂購。

So we do expect some additional revenue from our partners in the fourth quarter of this year and be relatively comparable to the quarter we just had. So I would model limited in Q3. And then 2026, we haven't gotten to yet because they haven't placed their orders yet.

因此，我們確實預計今年第四季我們的合作夥伴將帶來一些額外收入，並且與我們剛剛過去的季度相比相對可比。所以我會在第三季進行有限的建模。而到 2026 年，我們還沒有到達，因為他們還沒有下訂單。

And then on the -- our partners are going to do well. Kyowa Kirin is doing well in Japan with their sales for hyperphosphatemia. We did monetize that royalty stream with our partners with HealthCare Royalty Partners. And so I do expect that to grow throughout the -- every quarter, hopefully, as Kyowa Kirin does well in penetrating their space. They've had a very good launch. But that money is primarily passed through in full to HealthCare Royalty Partners. So any modest increase you see in noncash royalty revenue is offset by a corresponding debit, if you will, into our P&L.

然後——我們的合作夥伴將會做得很好。協和麒麟在日本高血磷治療藥物的銷售量很好。我們確實與 HealthCare Royalty Partners 的合作夥伴一起將該特許權使用費流貨幣化。因此，我確實希望它能夠在每個季度都實現成長，因為協和麒麟在其領域滲透方面做得很好。他們的發布會非常順利。但這筆錢主要全部轉給了 HealthCare Royalty Partners。因此，如果您願意的話，非現金特許權使用費收入的任何適度增長都會被我們的損益表中的相應借方所抵消。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

Hi, all. This is [Maisy] on for Roanna. Just one from us, I'm sorry if it's been asked already, but can you provide more granular detail on the current prescription mix between Medicare PAP and revenue-generating non-Medicare patients for XPHOZAH? And how do you expect this to evolve throughout the remainder of '25?

大家好。這是 [Maisy] 為 Roanna 主持的。我們只想問一個問題，如果這個問題已經被問過了，我很抱歉，但是您能否提供更多關於 Medicare PAP 和為 XPHOZAH 創收的非 Medicare 患者之間的當前處方組合的詳細信息？您預計這種情況在 2025 年剩餘時間內會如何發展？

Great question. So we don't talk about the number of scripts that are non-revenue, is we've not done that historically. But for Medicaid and commercial for XPHOZAH, roughly 50-50 is turning out the way we expected it to.

好問題。因此，我們不會談論非收入劇本的數量，因為我們歷史上沒有這樣做過。但對於 XPHOZAH 的醫療補助和商業補助來說，大約 50-50 的結果正如我們預期的那樣。

That concludes our question-and-answer session. Mike, we'll turn things back over to you for any additional or closing comments.

我們的問答環節到此結束。麥克，我們會把問題交還給您，以便您發表任何補充或結束評論。

Excellent. And thank you all for joining us this afternoon. We are as ever focused on our vision of a healthier tomorrow for patients and to maximizing shareholder value. With that, we can close the call. Thank you, Ellis.

出色的。感謝大家今天下午加入我們。我們一如既往地專注於為患者創造更健康的未來並最大化股東價值的願景。這樣，我們就可以結束通話了。謝謝你，埃利斯。

That concludes our meeting today. You may now disconnect.

今天的會議到此結束。您現在可以斷開連線。