Ardelyx Inc (ARDX) 2024 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Ardelyx third-quarter 2024 earnings call. Our host for today's call is Caitlin Lowie, Vice President of Corporate Communications and Investor Relations at Ardelyx. (Operator Instructions)

女士們、先生們，下午好，歡迎參加 Ardelyx 2024 年第三季財報電話會議。今天電話會議的主持人是 Ardelyx 企業傳播和投資者關係副總裁 Caitlin Lowie。 （操作員指令）

I would now like to turn the call over to your host. Caitlin, you may begin.

現在我想將電話轉給主持人。凱特琳，你可以開始了。

Thank you. Good afternoon, and welcome to our third-quarter 2024 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investors section of the company's website at ardelyx.com.

謝謝。下午好，歡迎參加我們的 2024 年第三季財務業績電話會議。在本次電話會議中，我們將參考今天稍早發布的新聞稿，該新聞稿可在公司網站 ardelyx.com 的投資者部分查閱。

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

在本次電話會議中，我們將做出受風險和不確定性影響的前瞻性陳述。我們的實際結果可能與描述的結果有重大差異。我們鼓勵您查看我們今天提交的最新 10-Q 表季度報告中的風險因素，您可以在我們的網站 ardelyx.com 上找到。雖然我們可能選擇在未來更新這些前瞻性陳述，但我們明確表示，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; Chief Commercial Officer, Eric Foster; and Chief Financial and Operations Officer, Justin Renz, will share prepared remarks before we open the call to questions.

我們的總裁兼執行長 Mike Raab；首席商務長 Eric Foster；財務和營運長賈斯汀·倫茨 (Justin Renz) 將在我們開始提問之前發表準備好的演講。

I will now hand the call over to Mike.

我現在將電話交給麥克。

Good afternoon, everyone, and thank you for spending part of your Halloween with us this year. It was a busy third quarter, and Eric, Justin, and I will bring you up to speed on the latest developments and provide some insight into what you can expect in the months ahead.

大家下午好，感謝大家今年與我們一起度過萬聖節。第三季非常繁忙，Eric、Justin 和我將向您通報最新進展，並對未來幾個月的預期提供一些見解。

IBSRELA is making a difference. We continue to hear from treating healthcare providers and patients that IBSRELA is delivering meaningful and important benefits to IBS-C patients who, despite treatment with established therapies, have continued to suffer from the symptoms of this debilitating condition.

IBSRELA 正在發揮作用。我們不斷從治療醫療保健提供者和患者那裡聽說，IBSRELA 為 IBS-C 患者帶來了有意義且重要的益處，儘管他們接受了既定療法治療，但仍然繼續遭受這種使人衰弱的疾病的症狀的困擾。

As you can see from the performance this quarter, demand for this effective first-in-class therapy continues to grow. We are excited about the future of IBSRELA. And with the latest expansion of our field force complete, our confidence that IBSRELA is a billion-dollar drug before patent expiry is as strong as ever.

從本季的表現可以看出，對這種有效的同類首創療法的需求持續成長。我們對 IBSRELA 的未來感到興奮。隨著我們實地力量的最新擴張，我們對 IBSRELA 在專利到期前成為價值 10 億美元的藥物的信心比以往任何時候都更加堅定。

XPHOZAH's launch continues at a phenomenal pace, demonstrating the clear unmet medical need among dialysis patients. We have said it before, and it continues to be true. There is a dire need for innovative therapies like XPHOZAH for dialysis patients.

XPHOZAH 的推出繼續以驚人的速度進行，顯示透析患者明顯存在未滿足的醫療需求。我們以前就說過這一點，而且現在仍然如此。透析患者迫切需要像 XPHOZAH 這樣的創新療法。

For almost 50 years, binders have been the only prescription therapy available to lower phosphorus levels. In under a year since launch, XPHOZAH's demonstrating the critical role it has in helping patients manage their hyperphosphatemia. Physicians are prescribing XPHOZAH because it works, and it is helping patients achieve serum phosphorus levels that have previously been unattainable.

近 50 年來，黏合劑一直是唯一可用於降低磷含量的處方療法。自推出以來不到一年的時間，XPHOZAH 就展示了其在幫助患者控制高磷血症方面發揮的關鍵作用。醫生開出 XPHOZAH 的處方是因為它有效，而且它可以幫助患者達到以前無法達到的血清磷水平。

The positive results they see in our patients drives this adoption. We, along with you, recognize that there is uncertainty around coverage for XPHOZAH for Medicare patients. This is why we've deployed multiple strategies with a goal to provide uninterrupted access to XPHOZAH for all patients.

他們在我們的患者身上看到的正面成果推動了我們的採用。我們和您一樣認識到，醫療保險患者對 XPHOZAH 的覆蓋範圍存在不確定性。這就是為什麼我們部署了多種策略，目標是讓所有患者都能不間斷地獲得 XPHOZAH。

Please allow me a moment to discuss how we got here. With the establishment of the end-stage renal disease prospective payment system, or bundle, CMS proposed to include in the bundle all drugs and biologics furnished during dialysis services. Their expectation was that the bundled payment would increase patient access to innovation and care while more efficiently managing the costs associated with dialysis.

請容許我花點時間來討論一下我們是如何到達這裡的。隨著末期腎病預付費系統（或稱為套餐）的建立，CMS 提議將透析服務期間提供的所有藥物和生物製劑都納入套餐中。他們的期望是捆綁支付可以增加患者獲得創新和護理的機會，同時更有效地管理與透析相關的費用。

The sad reality is that is not how it has turned out. Rather, as you've heard me say many times during our calls is that the unintended consequence of this policy is that patients end up with limited access to innovation, the complete opposite of what was the original intent.

可悲的現實並非如此。相反，正如您在我們通話中多次聽到我所說的那樣，這項政策的意外後果是患者最終無法獲得創新，這與最初的意圖完全相反。

Due to this erroneous way of thinking, access to much needed innovative drugs is significantly restricted, if not prohibited, causing some of those innovative therapies to effectively be removed from the market and a dearth of new innovative medications being developed for dialysis patients. This policy has resulted in negative patient experiences and poorer health outcomes.

由於這種錯誤的思維方式，人們急需的創新藥物的取得受到嚴重限制，甚至被禁止，導致一些創新療法實際上被排除在市場之外，並且針對透析患者開發的新型創新藥物也十分匱乏。這項政策導致了患者的不良體驗和較差的健康結果。

Historically, since the establishment of the bundle, oral-only therapies have not been included in the bundled payment for Medicare patients, but rather have been paid on a Medicare Part D. However, CMS continues on the path to eliminating coverage for oral-only therapies under Part D on January 1.

從歷史上看，自從捆綁治療建立以來，純口服療法就沒有被納入醫療保險患者的捆綁支付中，而是透過醫療保險 D 部分支付。 然而，CMS 繼續在 1 月 1 日取消 D 部分中對純口服療法的覆蓋範圍內。

Recall that we have been fighting for oral-only phosphate learning therapies to retain Part D coverage for Medicare patients since the potential benefit XPHOZAH could have for patients became apparent more than half a decade ago.

回想一下，自從五年多前 XPHOZAH 可能為患者帶來的潛在益處顯而易見以來，我們一直在爭取僅口服磷酸鹽學習療法，以保留醫療保險患者的 D 部分覆蓋範圍。

XPHOZAH is clinically proven to be a safe and effective medicine that offers something fundamentally different for the hundreds of thousands of dialysis patients who cannot tolerate phosphate binders or for whom a binder alone does not work well enough to achieve and maintain target phosphorus levels. We continue to fight on every front possible.

XPHOZAH 經臨床證明是一種安全有效的藥物，它為數十萬不能耐受磷酸鹽結合劑或單獨使用磷酸鹽結合劑無法達到和維持目標磷水平的透析患者提供了根本性的幫助。我們將繼續在一切可能的戰線上進行戰鬥。

We are partnered with a broad coalition of patient, physician, trade, community organizations and minority groups who are disproportionately impacted by kidney disease and dialysis, all of whom support the kidney Patient Act, bipartisan and bicameral legislation that we hope will be passed before the end of the year. There is tremendous support behind this bill with 38 co-sponsors in the house and 2 sponsors on the companion Senate bill.

我們與受腎臟疾病和透析影響特別嚴重的患者、醫生、貿易、社區組織和少數群體建立了廣泛的合作，他們都支持《腎臟病患者法案》和兩黨兩院立法，我們希望該法案能在年底前獲得通過。該法案獲得了巨大支持，眾議院有 38 位共同提案人，參議院配套法案也有 2 位提案人。

Separately, we in partnership with the American Association of kidney patients and the National Minority Quality Forum, have filed a lawsuit claiming that CMS' actions to include oral-only therapies in the bundle are outside of its statutory and regulatory authority. We are in the early stages of that lawsuit and hope that before the end of the year, the court will grant a preliminary injunction to enjoy CMS from proceeding with this plan.

另外，我們與美國腎臟病患者協會和全國少數族裔品質論壇合作，提起訴訟，聲稱 CMS 將僅口服療法納入捆綁治療的行為超出了其法定和監管權限。我們正處於該訴訟的早期階段，希望法院能在今年年底前頒發初步禁令，以阻止 CMS 繼續執行該計劃。

There's a third and essential element to our strategy. and that is the actions that we have taken to help protect access for patients and our business even if the legal or legislative options are unsuccessful. Importantly, we elected after significant research and discussion and careful consideration that the best way for Ardelyx to preserve the opportunity for broad access to XPHOZAH for all patients was to not apply for TDAPA.

我們的策略還有第三個也是最重要的要素。即使法律或立法選擇失敗，我們也採取了這些行動來幫助保護患者和我們業務的取得途徑。重要的是，經過大量研究、討論和仔細考慮後，我們決定，Ardelyx 為所有患者保留廣泛獲得 XPHOZAH 的機會的最佳方法是不申請 TDAPA。

We determined that by not applying for TDAPA, we would help preserve the shared decision-making process between patients and providers to ascertain the best course of therapy to manage hyperphosphatemia and to help ensure patients are not subject to a protocol that limits that critical relationship. Momentarily, Eric will share with you how the XPHOZAH team has begun to educate and communicate this approach.

我們決定，透過不申請 TDAPA，我們將有助於維護患者和醫療服務提供者之間的共同決策過程，以確定治療高血磷症的最佳療法，並有助於確保患者不會受到限制這種關鍵關係的協議的約束。稍後，Eric 將與您分享 XPHOZAH 團隊如何開始教育和傳播這種方法。

A short two months from now, by the end of 2024, we will know much more than we do today. I know that there are important truths that have brought Ardelyx to where we are today and will continue to drive us in the future.

短短兩個月後，到 2024 年底，我們將比今天了解更多。我知道，有一些重要的事實讓 Ardelyx 取得了今天的成就，並將繼續推動我們走向未來。

First, there are many patients who continue to struggle to manage their phosphorus. Second, XPHOZAH is an important medicine that we know is helping patients achieve target phosphorus levels. And third, Ardelyx is committed to ensuring that patients who are prescribed our medicines have access to treatment.

首先，許多患者仍在努力控制體內的磷含量。其次，我們知道 XPHOZAH 是一種重要的藥物，它可以幫助患者達到目標磷水平。第三，Ardelyx 致力於確保服用我們藥物的患者能夠得到治療。

We believe that the decision to pursue and support legal legislative and commercial strategies has positioned us to help ensure that XPHOZAH is available for all patients regardless of the scenario we find ourselves in on January 1. We believe there is an important and substantive business for XPHOZAH in all scenarios. As we learn more over the ensuing months, we will be able to provide you with greater clarity.

我們相信，追求和支持合法立法和商業策略的決定使我們能夠幫助確保所有患者都可以使用 XPHOZAH，無論我們在 1 月 1 日遇到何種情況。隨著我們在接下來的幾個月中了解更多信息，我們將能夠為您提供更清晰的說明。

Critical to our success will be the work that Eric and his team are doing. I'm really excited to welcome Eric not only to this call but to Ardelyx. In a short time, Eric has brought a fresh perspective to our team and deep knowledge and insight to help lead us through the uncertainty we face with Medicare reimbursement for XPHOZAH, and the opportunities to accelerate the growth of IBSRELA and XPHOZAH while positioning our commercial organization to take advantage of other products we may develop, in-license or acquire as we continue to build an important patient-centric enterprise.

埃里克和他的團隊所做的工作對於我們的成功至關重要。我非常高興歡迎 Eric 不僅參加這次電話會議，也歡迎他加入 Ardelyx。在短時間內，Eric 為我們的團隊帶來了全新的視角以及深厚的知識和洞察力，幫助我們解決 XPHOZAH 醫療保險報銷所面臨的不確定性，以及加速 IBSRELA 和 XPHOZAH 增長的機會，同時使我們的商業組織能夠利用我們可能開發、許可或收購的其他產品，繼續打造一個以患者為中心的重要企業。

Eric will review the third quarter's performance and provide more detail on how we are advancing our commercial strategies for the future. Eric?

艾瑞克將回顧第三季的表現，並詳細介紹我們如何推進未來的商業策略。埃里克？

Thanks, Mike, for that kind introduction. I'm thrilled to join you all today and to be a part of Ardelyx and the remarkable growth story that I see ahead. Before I speak to the successes from the quarter, I'd like to share a patient story like so many that we hear every day that reinforces why we do what we do.

謝謝 Mike 的熱情介紹。我很高興今天能和大家在一起，成為 Ardelyx 的一部分，見證我所預見的非凡成長故事。在談到本季的成功之前，我想先分享一個患者的故事，就像我們每天都會聽到的許多故事一樣，這個故事進一步證明了我們這樣做的原因。

Recently, a patient's caregiver contacted us because her mother, a long-time IBS-C suffer had been given a sample of IBSRELA. This patient had suffered with the symptoms of IBS-C for a long time and had tried many treatment options. She spoke about how her mother wanted to live a full life, but our GI issues continue to take over. They were excited about IBSRELA because they heard it was a different option, and they were eager to get started on treatment.

最近，一位患者的照顧者聯繫了我們，因為她的母親，一位長期患有 IBS-C 的患者，已經獲得了 IBSRELA 的樣本。這位患者長期患有 IBS-C 症狀並嘗試過多種治療方法。她說，她的母親想要過著充實的生活，但我們的胃腸道問題一直困擾著我們。他們對 IBSRELA 感到非常興奮，因為他們聽說這是一個不同的選擇，並且他們渴望開始治療。

It's stories like this one that attracted me to Ardelyx. IBSRELA is a unique and different option for patients suffering from IBS-C and we are deeply committed to supporting patients to access therapy.

正是像這樣的故事吸引了我關注 Ardelyx。對於患有 IBS-C 的患者來說，IBSRELA 是一種獨特且不同的選擇，我們致力於支持患者接受治療。

For nearly 25 years, I have dedicated my career to bringing meaningful medicines to patients, and I have seen firsthand how innovative therapies can dramatically improve patients' lives. And it is evident that IBSRELA and XPHOZAH medicines discovered and developed by Ardelyx, offer much needed and truly different options for patients. After spending time recently in the field and engaging directly with providers as well as working closely with the commercial leadership team, it is clear that we have a solid foundation in place.

近 25 年來，我致力於為患者提供有意義的藥物，並親眼目睹創新療法如何大幅改善患者的生活。顯然，Ardelyx 發現和開發的 IBSRELA 和 XPHOZAH 藥物為患者提供了急需的、真正不同的選擇。經過最近在現場花費的時間、直接與供應商接觸以及與商業領導團隊密切合作之後，很明顯我們已經打下了堅實的基礎。

First, there are so many patients with IBS-C and hyperphosphatemia, these conditions are not well managed and now have different options with IBSRELA and XPHOZAH. Second, patients have a defined path to access, they are receiving treatment, and they are having positive benefits, resulting in more physicians adopting IBSRELA and XPHOZAH.

首先，患有 IBS-C 和高磷血症的患者非常多，這些病症無法得到良好的控制，現在可以使用 IBSRELA 和 XPHOZAH 來治療。其次，患者有明確的獲取途徑，他們正在接受治療，並且獲得了積極的好處，從而導致更多醫生採用 IBSRELA 和 XPHOZAH。

And third, we have a high-performing and committed team that is focused on removing barriers and bringing these medicines to patients as quickly as possible. As a result of our commercial approach, we delivered consistent growth for both medicines during the third quarter.

第三，我們擁有一支高效、敬業的團隊，致力於消除障礙，盡快將這些藥物送到患者手中。由於我們採取商業化方式，我們在第三季度實現了兩種藥物的持續成長。

Let me first start with IBSRELA. Growth continued at a very strong pace, recording a 15% increase in net sales over the second quarter. We continue to see significant demand for IBSRELA reflected in continued growth across all of our key demand metrics including new and refill prescriptions and new and repeat riders.

讓我先從 IBSRELA 開始。成長持續保持強勁，第二季淨銷售額成長 15%。我們繼續看到對 IBSRELA 的巨大需求，這反映在我們所有關鍵需求指標（包括新處方和補充處方以及新附加條款和重複附加條款）的持續增長中。

We also began to see encouraging indicators of the impact of the sales team that we hired early in the expansion process. Recently, I returned from the American College of Gastroenterology Annual Scientific Meeting and the response from the GI community to IBSRELA was incredible.

我們也開始看到令人鼓舞的跡象，顯示我們在擴張過程早期聘用的銷售團隊產生了影響。最近，我剛從美國胃腸病學會年度科學會議回來，胃腸病學界對 IBSRELA 的反應令人難以置信。

IBSRELA is well established as a meaningful treatment for healthcare providers who now have a different option to treat this complex condition. We also used the conference as an opportunity to highlight key data. We recently collected as part of the IBS and America 2024 supplemental survey related to the impact that IBS-C has on the lives of patients. 90% of those patients surveyed indicated that their conditions had a negative impact on their life with a majority indicating they feel a negative impact on their mental and emotional health, intimacy, relationships and sense of independence.

IBSRELA 已被證實是一種對醫療保健提供者有意義的治療方法，他們現在可以透過不同的選擇來治療這種複雜的疾病。我們也利用這次會議的機會強調了關鍵數據。作為 IBS 和美國 2024 補充調查的一部分，我們最近收集了與 IBS-C 對患者生活的影響相關的數據。 90% 的受訪患者表示，他們的病情對他們的生活產生了負面影響，其中大多數人表示，他們感覺自己的心理和情緒健康、親密關係、人際關係和獨立性感受到了負面影響。

More than one-third surveyed patients describe their quality of life as poor or fair. These results further reinforce our recognition that there are a significant number of patients who continue to experience the symptoms of their condition and could benefit from IBSRELA. Our team is focused on driving demand for IBSRELA supported by the expansion of our field sales team, which I'm happy to tell you was completed towards the end of the third quarter.

超過三分之一的受訪患者認為他們的生活品質較差或普通。這些結果進一步強化了我們的認識，即有相當多的患者繼續經歷其病情的症狀，並且可以從 IBSRELA 中受益。我們的團隊致力於推動 IBSRELA 的需求，並透過擴大我們的現場銷售團隊來提供支持，我很高興地告訴您，這項工作已在第三季末完成。

Moving forward, our team is trained, ready and they are in the field. we expect to see increased effort and impact from this expansion. The team is focused on driving broad adoption and accelerating growth by helping our target HCPs expand their view the appropriate IBSRELA patient.

展望未來，我們的團隊已訓練有素、準備就緒，並且正在實地工作。我們期望看到此次擴張帶來的更多努力和影響。該團隊致力於透過幫助我們的目標 HCP 擴大對合適的 IBSRELA 患者的看法來推動廣泛採用並加速成長。

We remain uniquely positioned as the only non-secretagogue option in a different class with clinically proven efficacy and safety for IBS-C patients. We continue to be encouraged by the success of IBSRELA and are confident in our path to $1 billion. I look forward to sharing more details on our expectations and plans for IBSRELA in the future.

我們仍然佔據著獨特的地位，是不同類別中唯一經過臨床驗證對 IBS-C 患者有效且安全的非促泌劑選擇。 IBSRELA 的成功持續鼓舞著我們，我們對實現 10 億美元目標充滿信心。我期待未來分享更多有關我們對 IBSRELA 的期望和計劃的細節。

Now moving to XPHOZAH. XPHOZAH continues to deliver an exceptional launch recording a 39% increase in net sales revenue growth quarter over quarter, anchored by key foundational elements. There is a large population of patients whose hyperphosphatemia is not well managed despite treatment with a phosphate binder. XPHOZAH provides a nonbinder option that is clinically proven to be safe and effective. This is an established market with a targeted call point for our sales team and nephrologists are receptive to XPHOZAH's clinical profile and messaging.

現在轉向 XPHOZAH。 XPHOZAH 繼續實現出色的發布，在關鍵基礎要素的推動下，淨銷售收入環比增長 39%。大量患者的高磷血症儘管接受了磷酸鹽結合劑治療，但仍未得到很好的控制。 XPHOZAH 提供非黏合劑選擇，經臨床證明是安全有效的。這是一個成熟的市場，為我們的銷售團隊提供了目標呼叫點，腎臟病專家也樂於接受 XPHOZAH 的臨床概況和資訊。

And finally, there is a defined path to access. The strong performance and response for the nephrology community reflects the need among patients for XPHOZAH to help lower and manage phosphate levels to target.

最後，有一個定義的存取路徑。腎臟病學界的強勁表現和反應反映了患者需要 XPHOZAH 來幫助降低和控制磷酸鹽水平。

Since launch, patients are getting on treatment and seeing phosphorus levels come down and remain at target levels. We consistently hear stories of patients who are now seeing the benefits of XPHOZAH after struggling for years to control their phosphorus on binders alone. Their sentiment was clear at last week's Annual Kidney Week held by the American Society of Nephrology.

自推出以來，患者接受治療後磷水平下降並保持在目標水平。我們不斷聽到這樣的病患故事：他們多年來一直難以僅透過黏合劑控制磷，現在透過 XPHOZAH 看到了好處。在上周美國腎臟病學會舉辦的年度腎臟週活動上，他們的情緒表現得非常明顯。

As Mike discussed earlier, irrespective of the uncertainty related to Part D coverage for Medicare patients, we are not changing what we are doing today. Our field-based team continues to encourage nephrologists to prescribe just as they do today based on a patient's clinical need. We are helping the nephrology community and care teams to understand that even in the event that Medicare Part D coverage is eliminated, their ability to prescribe XPHOZAH remains unchanged.

正如麥克之前所討論的，無論與醫療保險患者的 D 部分覆蓋範圍相關的不確定性如何，我們都不會改變今天正在做的事情。我們的實地團隊繼續鼓勵腎臟科醫師根據患者的臨床需求開出處方，就像他們今天所做的那樣。我們正在幫助腎臟病學社區和護理團隊了解，即使在 Medicare Part D 覆蓋範圍被取消的情況下，他們開立 XPHOZAH 的能力仍然保持不變。

The XPHOZAH team remains steadfast on driving demand today and demonstrating the benefit that XPHOZAH brings to patients.

XPHOZAH 團隊如今仍堅定不移地推動需求並展示 XPHOZAH 為患者帶來的好處。

Today, just three months in, I'm even more excited about Ardelyx future and our ability to help the patients that we serve. We are just scratching the surface and the potential for IBSRELA and XPHOZAH is significant, and it is up to us to capture that opportunity and to capture it as quickly as possible.

今天，僅僅三個月過去了，我對 Ardelyx 的未來以及我們幫助患者的能力感到更加興奮。我們才剛剛觸及表面，IBSRELA 和 XPHOZAH 的潛力是巨大的，我們必須抓住這個機會，並儘快抓住它。

I will now hand it over to Justin, who will walk you through the financials from the third quarter. Justin?

現在我將話題交給賈斯汀，他將向大家介紹第三季的財務狀況。賈斯汀？

Thank you, Eric, and it's great to have you on these calls and at our Ardelyx. We recorded an exceptionally strong performance during the third quarter, focusing on driving our top-line growth, managing our expenses, and adding to our cash position. We entered the fourth quarter with positive momentum and expectations of continued growth and a strong balance sheet to support future opportunities.

謝謝你，Eric，很高興你能參加這些電話會議並來到我們的 Ardelyx。我們在第三季取得了異常強勁的業績，重點是推動我們的營收成長、管理我們的費用並增加我們的現金狀況。我們進入第四季時勢頭良好，預計將繼續成長，強勁的資產負債表將為未來機會提供支援。

Now let's walk through the financials, starting with revenue. We reported $98.2 million in total revenue during the third quarter compared to $56.4 million in total revenue during the same period in 2023, driven by significant growth in net product sales for both products. For the third quarter of 2024, net product sales revenue for IBSRELA was $40.6 million, nearly double our revenue from the same period of 2023 and 15% quarter-over-quarter growth compared to the second quarter of this year, driven by strong demand.

現在讓我們來看看財務狀況，從收入開始。我們報告第三季的總收入為 9,820 萬美元，而 2023 年同期的總收入為 5,640 萬美元，這得益於兩種產品的淨產品銷售額的大幅增長。 2024 年第三季度，在強勁需求的推動下，IBSRELA 的淨產品銷售收入為 4,060 萬美元，幾乎是 2023 年同期收入的兩倍，與今年第二季度相比增長了 15%。

Our third-quarter gross to net deduction for IBSRELA was 30.0%, consistent with our prior quarter. As a result of the strong performance in the third quarter as well as the expected impact of the expanded sales force, we are narrowing our guidance and expect full year 2024 IBSRELA U.S. net product sales revenue to be between $145 million and $150 million.

我們第三季的 IBSRELA 毛淨扣除額為 30.0%，與上一季一致。由於第三季的強勁表現以及擴大銷售隊伍的預期影響，我們縮小了預期範圍，預計 2024 年全年 IBSRELA 美國淨產品銷售收入將在 1.45 億美元至 1.5 億美元之間。

Now turning to XPHOZAH. XPHOZAH continued its exceptional launch, reporting $51.5 million in third quarter net product sales revenue, up from $37.1 million we reported in the second quarter of 2024. This was driven by strong demand from healthcare providers who clearly need a new and different option for dialysis patients to help them achieve target phosphorus levels.

現在轉向 XPHOZAH。 XPHOZAH 繼續其出色的發布，報告第三季度淨產品銷售收入為 5150 萬美元，高於我們在 2024 年第二季度報告的 3710 萬美元。

In addition to strong demand for XPHOZAH, our gross to net deduction improved from 21.4% in the second quarter to 19.3% for the third quarter. We are pleased with our top-line results and expect continued growth in the fourth quarter. Our commercial approach is working, and our teams are executing at the highest level to build and maintain the momentum we have established for both IBSRELA and XPHOZAH.

除了對 XPHOZAH 的強勁需求外，我們的總淨扣除額從第二季的 21.4% 提高到第三季的 19.3%。我們對我們的營業業績感到滿意，並預計第四季度將繼續成長。我們的商業方法正在發揮作用，我們的團隊正在以最高水平執行，以建立和維持我們為 IBSRELA 和 XPHOZAH 建立的勢頭。

In addition to product revenue, we also had $5.3 million in partner product supply revenue as well as just over $800,000 in noncash royalty revenue during the third quarter of 2024.

除了產品收入外，2024 年第三季我們還獲得了 530 萬美元的合作夥伴產品供應收入以及略高於 80 萬美元的非現金特許權使用費收入。

And now for the expense and cash side. Research and development expenses were $15.3 million in the third quarter of 2024 compared to $8.6 million during the same period of last year, reflecting increased medical engagement with scientific communities and pediatric clinical trial activities.

現在談談費用和現金方面。 2024 年第三季的研發費用為 1,530 萬美元，而去年同期為 860 萬美元，這反映了醫學界與科學界以及兒科臨床試驗活動的參與度增加。

Selling, general, and administrative expenses were $65.0 million for the third quarter compared to $32.7 million for the same period of 2023. The increase was related to commercial activities for IBSRELA and XPHOZAH as well as the expansion of the IBSRELA sales team. Substantial top-line growth combined with thoughtful expense management resulted in a net loss of approximately $800,000 or less than $0.01 per share.

第三季的銷售、一般和行政費用為 6500 萬美元，而 2023 年同期為 3,270 萬美元。大幅的營收成長加上周到的費用管理導致淨虧損約 80 萬美元，即每股不到 0.01 美元。

In addition, our third-quarter 2024 results included $11.1 million in combined non-cash expenses from share-based compensation and non-cash interest expense related to the sale of future royalties.

此外，我們 2024 年第三季的業績包括來自股權激勵的綜合非現金支出 1,110 萬美元以及與出售未來特許權使用費相關的非現金利息支出。

We finished the third quarter in a strong cash position. As of September 30, 2024, we had total cash, cash equivalents, and short-term investments of $190.4 million as compared to $184.3 million at the end of 2023 and $186 million at the end of the second quarter.

我們以強勁的現金狀況結束了第三季。截至 2024 年 9 月 30 日，我們的現金、現金等價物及短期投資總額為 1.904 億美元，而 2023 年底為 1.843 億美元，第二季末為 1.86 億美元。

As we continue to thoughtfully strengthen our balance sheet, we announced today that we drew $50 million and amended our debt agreement with SLR Capital. This amendment allows us to draw an additional $50 million sets the interest rates from the tranche we drew today and the additional $50 million of committed capital at SOFR plus 4.02% and following extended the interest-only period to July 1, 2028, for all borrowings.

隨著我們繼續深思熟慮地加強我們的資產負債表，我們今天宣布提取 5000 萬美元並修改了與 SLR Capital 的債務協議。這項修正案允許我們額外提取 5000 萬美元，將我們今天提取的部分和額外的 5000 萬美元承諾資本的利率設定為 SOFR 加 4.02%，然後將所有借款的僅付息期延長至 2028 年 7 月 1 日。

The strong cash position we finished the third quarter with combined with the addition of $50 million gives us a pro forma cash balance of over $240 million, providing optionality as we pursue our goal of building a patient-centric enterprise that Mike mentioned earlier.

我們在第三季結束時擁有強勁的現金狀況，再加上新增的 5,000 萬美元，使我們的預計現金餘額超過 2.4 億美元，為我們追求 Mike 之前提到的建立以患者為中心的企業的目標提供了選擇權。

To recap, we have once again delivered a remarkable performance. we drove substantial top-line growth across our product lines, and we expect continued growth in the fourth quarter. We managed our operating expenses, maintained a strong balance sheet and always, as always, focus on maximizing shareholder value.

總而言之，我們再次取得了卓越的成績。我們推動了所有產品線的營收大幅成長，預計第四季將繼續成長。我們管理了營運費用，保持了強勁的資產負債表，並始終一如既往地專注於實現股東價值最大化。

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

說完這些，我就把麥克風交還給麥克。

Thank you, Justin and Eric. The third quarter was another exceptional one. We focused on executing our key priorities, including maintaining our commercial momentum, supporting efforts to preserve patient access to XPHOZAH, strengthen our cash position and envision the next phase of growth for the company. The result is another quarter of excellent progress, consistent growth and most importantly, doing what is right for the patients we serve. Because we believe that if we serve patients, we will serve shareholders.

謝謝你，賈斯汀和艾瑞克。第三季又是一個異常的季度。我們專注於執行我們的關鍵優先事項，包括保持我們的商業勢頭、支持努力保持患者獲得 XPHOZAH 的機會、加強我們的現金狀況以及展望公司下一階段的成長。結果是，本季度取得了優異的進展，持續的成長，最重要的是，我們為患者做了正確的事情。因為我們相信，如果我們服務於患者，我們就會服務股東。

Before I open the call to questions, I want to thank our shareholders who have followed and supported us on this journey. We will learn much in the weeks and months ahead together. You have our commitment that we will continue to make decisions that are in the best interest of patients, employees and you, our shareholders.

在我開始提問之前，我想感謝我們的股東們在這一歷程中一直關注和支持我們。在未來的幾週和幾個月裡，我們將一起學習很多東西。我們向您承諾，我們將繼續做出符合病人、員工和您（我們的股東）最佳利益的決策。

And as always, I want to express a special thanks to team Ardelyx and the patients and physicians we serve. You are the driving force behind what we do.

像往常一樣，我要向 Ardelyx 團隊以及我們服務的患者和醫生表示特別的感謝。您是我們所做的一切的推動力量。

I will now open the call to questions. Operator?

我現在開始回答提問。操作員？

(Operator Instructions). Louise Chen, Cantor Fitzgerald.

（操作員指令）。路易絲陳，菲茨傑拉德領唱者。

Congratulations on the quarter. So I had a few for you. I wanted to ask you what percent of XPHOZAH sales are not part of the Medicare bundle. And then how do you think about expanding your product portfolio? You talked about that a few times today.

恭喜本季取得佳績。所以我幫你準備了一些。我想問您 XPHOZAH 銷售額中有多少百分比不屬於醫療保險套餐的一部分。那麼您考慮如何擴大您的產品組合呢？您今天已經談過幾次了。

And last question I had for you was the peak sales for IBSRELA being $1-plus billion, how long do you think it will take to achieve that?

我要問您的最後一個問題是，IBSRELA 的峰值銷售額將超過 10 億美元，您認為需要多長時間才能實現這一目標？

Louise, great questions. So first, in terms of percentages, I think what we've shared in the past is the general numbers of 60% Medicare, 40% non-Medicare. And that moves around a little bit, but that's a good general way to think about it.

路易絲，很棒的問題。首先，就百分比而言，我認為我們過去分享的一般數字是 60％ 為醫療保險，40％ 為非醫療保險。這有點不太對勁，但這是一種很好的思考方式。

In terms of your second question of how we expand beyond. Now that's the reason that we brought on Mike Kelleher, and those efforts are beginning now and ongoing. We now have the luxury of the strong balance sheet that we've been able to build and continue to doing that going forward. So more news I expect coming from those efforts in the future.

關於你的第二個問題，我們要如何擴展。這就是我們聘請麥克凱萊赫的原因，這些努力現在已經開始並持續進行。我們現在已經擁有了強勁的資產負債表，並且能夠繼續保持下去。因此我期待未來這些努力能帶來更多新消息。

And I'm sorry, the third question?

抱歉，第三個問題？

The third question was just on your peak sales for IBSRELA.

第三個問題是關於 IBSRELA 的峰值銷售情況。

Yeah. I mean, I think at this stage, it's probably a little bit too early to give a specific number on that. We just finished the expansion. And as Eric mentioned in his comments, they're trained in the field, ACG was a phenomenal turn out for that team, and let's hold off on that until we see the performance with the addition.

是的。我的意思是，我認為現階段，給出具體的數字可能還為時過早。我們剛剛完成擴建。正如 Eric 在評論中提到的那樣，他們接受過實地訓練，ACG 的表現對於該隊來說是一個非凡的成績，我們暫且不談這個，直到我們看到新隊員的表現。

Our next question comes from Dennis Ding of Jefferies.

我們的下一個問題來自 Jefferies 的 Dennis Ding。

Few from me. So for XPHOZAH in 2025, given it's been a few months since you announced you won't apply for TDAPA, like what are the different options on the table in terms of commercial strategy? And if you could be a little bit lower more granular.

我很少有這樣的。那麼對於 2025 年的 XPHOZAH，考慮到距離您宣布不會申請 TDAPA 已經有幾個月了，那麼在商業策略方面有哪些不同的選擇？如果您可以更詳細地了解一下的話。

And then on IBSRELA, just talk on the pushes and pulls on the guidance. It seems a little bit conservative. Was there anything one-timer or anything that you see on the ground?

然後在 IBSRELA 上，只談論指導上的推動和拉動。這似乎有些保守。有沒有什麼一次性的東西或是你在地面上看到的東西？

Yeah. So let me address the second one first. As you've heard me say probably too many times, I don't want to get over my skis. And we just finished the expansion with the additional adds to the IBSRELA team. So I'm very encouraged by what we see.

是的。因此讓我先解決第二個問題。正如你可能聽我說過很多次的那樣，我不想摔倒我的滑雪板。我們剛剛完成了擴展，並增加了 IBSRELA 團隊的成員。我對我們所看到的結果感到非常鼓舞。

And I think narrowing the guidance gives you some sense in terms of our confidence. So there's not there, there that's negative. I see only positives in terms of the expansion of what we saw in ACG.

我認為縮小指導範圍會讓我們對我們的信心產生一些認識。所以那裡沒有，那裡是負面的。從我們在 ACG 中看到的擴展來看，我只看到積極的一面。

In terms of what it looks like going forward, I think we really pay attention to what Eric said. The objective here is for physicians not to change what they're doing today. This is a coverage issue is the way to simply think about it. And our objective is clearly with everything that we do and have done is to ensure the opportunity for access for all patients, which we believe we're doing with the three approaches I described.

對於未來的發展，我認為我們確實應該關注艾瑞克所說的話。這裡的目標是讓醫生不要改變他們今天的工作。這是一個覆蓋問題，可以簡單地這麼想。我們的目標顯然是，我們所做的和已經做的一切是為了確保所有患者都有機會獲得治療，我們相信我們正在透過我所描述的三種方法來實現這一目標。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

So a couple for me. I was curious if you could elaborate a bit more on your plans around possible education and outreach to prescribers of XPHOZAH ahead of January 1. And I know there's a lot of moving pieces, but I was also curious if what you're thinking about in terms of engaging with different payers, particularly the non-Medicare side as well?

所以對我來說這是一對。我很好奇，您是否可以詳細說明一下在 1 月 1 日之前對 XPHOZAH 處方人員進行教育和推廣的計劃。

Yeah. So I'll ask Eric to comment a little bit on that. It's really kind of a simple message, don't change what you're doing, right? And going into next year, if we aren't successful with that third leg of the stool in the strategy, is that they continue doing what they're doing.

是的。因此我想請埃里克對此發表一點評論。這真的是一個簡單的訊息，不要改變你正在做的事情，對嗎？進入明年，如果我們不能成功地實施策略中的第三條腿，他們就會繼續做他們正在做的事情。

And I think as the message is beginning to resonate, I'll ask Eric to comment on his experiences at ASN, which just happened as well as this message began to percolate.

我認為，隨著這個消息開始引起共鳴，我會請艾瑞克評論一下他在 ASN 的經歷，這件事恰好發生在這個消息開始傳播的時候。

Yeah. Thanks, Mike. So what we know physicians are very interested in XPHOZAH and this treatment to address the unmet need that's out there. Just like we're thinking for 2025, physicians don't differentiate between the Medicare population and the non-Medicare population. So we're going to continue to message the clinical benefits today as well as access to therapy and continue that in 2025, keeping the nephrologist at the center of the decision making.

是的。謝謝，麥克。因此，我們知道醫生對 XPHOZAH 非常感興趣，而這種治療方法可以解決尚未滿足的需求。正如我們對 2025 年的設想，醫生不會區分醫療保險族群和非醫療保險族群。因此，我們將繼續宣傳當今的臨床益處以及獲得治療的機會，並在 2025 年繼續這樣做，讓腎臟病專家成為決策的中心。

And I can tell you, just coming off of ASN, there continues to be a tremendous amount of excitement on XPHOZAH and the opportunity ahead -- and like I said, the physicians aren't really differentiating between Medicare and non-Medicare. So we need to continue to be steadfast in our execution in delivering those clinical messages so that physicians can make the best choice for their patients based on clinical needs.

我可以告訴你，剛從 ASN 回來，人們對 XPHOZAH 和未來的機會仍然非常興奮——而且就像我說的，醫生們並沒有真正區分醫療保險和非醫療保險。因此，我們需要繼續堅定不移地傳遞這些臨床訊息，以便醫生能夠根據臨床需求為患者做出最佳選擇。

And to your -- the latter part of your question is there's nothing unique in any communication that we have with payers, right? It is status quo in the way that we're operating through our ArdelyxAssist to have those patients go through the prior authorization process. So we don't have -- I mean it sounds funny, but it's keep doing what you've been doing, which the decisions we've made allows that to occur.

對於您問題的後半部分，我們與付款人的溝通並沒有什麼獨特之處，對嗎？我們透過 ArdelyxAssist 的運作方式目前是讓這些患者經過事先授權流程。所以我們沒有——我的意思是這聽起來很有趣，但你會繼續做你一直在做的事情，我們所做的決定允許這種情況發生。

Yigal, Citigroup.

伊加爾，花旗集團。

This is Reena on for Yigal. I was just wondering if you've made any progress with regard to the injection to temporarily hold implementation of including orals in the dialysis bundle in 2025. Like any additional color there would be much appreciated.

這是 Reena 代替 Yigal 上場。我只是想知道，在註射方面是否取得了任何進展，暫時推遲在 2025 年將口服藥物納入透析組合的實施。

Yeah. I think as you heard in my opening comments, we hope that there would be some action on that before the end of the year. Otherwise, there's not really any additional insight that we can provide.

是的。我想正如你在我的開場白中聽到的那樣，我們希望在今年年底之前採取一些行動。否則，我們實際上無法提供任何額外的見解。

Laura Chico, Wedbush Securities.

勞拉‧奇科（Laura Chico），韋德布希證券公司。

Just one, Justin, I think I missed what you said on the gross to net improvement in the quarter for XPHOZAH and then with respect to IBSRELA, what would be appropriate timing for 2025 guidance?

只有一個問題，賈斯汀，我想我錯過了你所說的 XPHOZAH 本季度毛利與淨利的改善，然後關於 IBSRELA，2025 年指引的適當時間是什麼時候？

Yeah. So Laura, is the latter part first. As we look at the performance of the addition of the sales force [new AVD], let that settle in a bit before we give guidance, but it will be in the early part of the next year. We won't leave you hanging too long. Justin?

是的。那麼勞拉，首先是後者。當我們觀察新增銷售團隊（新 AVD）的表現時，我們會讓它穩定下來，然後再給予指導，但這將是在明年年初。我們不會讓您久等。賈斯汀？

Thank you, Laura. In the third quarter, our gross to net deduction improved from 21.4% to 19.3% in the third quarter. So this improvement was primarily dependent on our patient payer mix. The utilization of our commercial co-pay and mild changes there.

謝謝你，勞拉。第三季度，我們的總淨扣除額從 21.4% 提高到 19.3%。因此，這種改善主要取決於我們的患者付款人組合。我們的商業共同支付的利用率和那裡的輕微變化。

As you might imagine, we're pleased with the results to date. And as we learn more about the patient mix and the co-pay claims and the amount of the claims will give you more guidance going forward like we do for IBSRELA where we mentioned 30 plus or minus 5% is the general role.

正如您可能想像的那樣，我們對迄今為止的結果感到滿意。隨著我們對患者結構、共同支付索賠和索賠金額的了解越來越多，我們將為您提供更多指導，就像我們對 IBSRELA 所做的那樣，我們提到 30 加減 5% 是一般規定。

Joseph Thome, TD Cowen.

約瑟夫·托米（Joseph Thome），TD Cowen 公司。

Maybe just going into the fourth quarter, do you expect any differing dynamics in terms of stocking of XPHOZAH or any pull forward of prescriptions or anything that might be possible, I guess, for either the patients or the physicians to almost prepare for a potential bundle scenario -- or you -- do you think there will be anything to point out there?

也許只是進入第四季度，您是否預計 XPHOZAH 的庫存方面會有任何不同的動態，或者處方的提前，或者任何可能的情況，我想，無論是患者還是醫生，幾乎都要為潛在的捆綁情景做好準備 - 或者您 - 您認為有什麼需要指出的嗎？

And then second, just on the XPHOZAH court case, obviously, the legislation side is a little bit more maybe straightforward if that's able to go through. But if the injunction is granted by the end of the year, what's the next step? Then kind of how much visibility would you have after that standpoint on next steps?

其次，就 XPHOZAH 法庭案件而言，如果能夠通過，立法方面顯然會更加簡單。但如果禁令在年底前獲得批准，下一步該怎麼做？那麼從這個角度來看，您對下一步的行動有多少預見性？

Joe, thanks. I think if that were to occur, we'll provide more perspective what that then means if we get that. It's premature at this point to give any more information than that. As it relates to pulling things forward. What I would say is what the team has put in place is a continuity of care program, which I think is very important to not have stuff like that occur, where if you are prescribing for a Medicare patient, you can come into a continuative care program until things resolved.

喬，謝謝。我認為，如果發生這種情況，我們將提供更多的觀點來解釋這意味著什麼。目前提供更多資訊還為時過早。因為它與推動事物向前發展有關。我想說的是，團隊已經實施了持續護理計劃，我認為這對於避免類似事件發生非常重要，如果您為醫療保險患者開處方，您可以參加持續護理計劃，直到問題得到解決。

So I wouldn't anticipate that. I don't know, Eric, any comments that you would like to share on that?

所以我不會預料到這一點。我不知道，艾瑞克，你對此有什麼評論嗎？

No, I agree. I think we've got a great program with continuity of care, and we've got really good relationships with wholesalers and distributors and there really hasn't been any conversations about that.

不，我同意。我認為我們有一個很棒的持續護理計劃，並且我們與批發商和分銷商保持著良好的關係，而且我們確實沒有就此進行過任何對話。

Great. And then maybe just one more question for me. I guess, does it seem like the dialysis centers are even preparing, I guess, for this change January 1. It seems like this would be a big change for just like a light switch on and off. I guess, are you seeing anything at the dialysis centers themselves that would indicate that the preparing or not preparing one way or the other?

偉大的。那也許我還有一個問題。我猜，透析中心似乎正在為 1 月 1 日的變化做準備。我想，您是否在透析中心看到任何東西，表明正在進行準備或未進行準備？

No. I think, Joe, one of the biggest challenges for all dialysis providers. And certainly, the independents, the rural and the small and nonprofits is the infrastructure that must be put in place to manage pills and everything that's going to come from this is going to be debilitating for many. And that is one of the fundamental risks honestly, of what this policy is ultimately going to do is further make dialysis a difficult thing for patients to get access to.

不。當然，獨立機構、農村機構、小型和非營利組織是必須建立的管理藥物的基礎設施，而由此產生的一切都會對許多人造成損害。說實話，這是該政策的根本風險之一，最終將使患者更難以獲得透析治療。

We certainly know rural communities where people three times a week are having to drive hours to be dialyzed. They need that to live. So yes, there are efforts they have to underway, which is the basis of an awful lot of those providers supporting the kidney patient at it's a catastrophe and it's bad policy and it's bad for patients, which is why we're working so diligently both on the Patient Act and the legal front.

我們當然知道，在農村地區，人們每週三次必須開車幾個小時去做透析。他們需要這個才能生存。所以是的，他們必須做出努力，這是許多服務提供者為腎臟病患者提供支援的基礎，這是一場災難，是一項糟糕的政策，對患者不利，這就是為什麼我們在《患者法案》和法律方面都如此努力地工作。

Ryan Deschner, Raymond James

瑞安德施納、雷蒙德詹姆斯

Congrats on another strong quarter for both IBSRELA and XPHOZAH. My question is, how much of the uptick we are seeing in IBSRELA scripts over the past few months? Are you directly attributing to getting the expanded sales team online versus other factors? As every member of this team now up fully trained and deployed. And then also a follow-up question.

恭喜 IBSRELA 和 XPHOZAH 又一個季度表現強勁。我的問題是，在過去幾個月中，我們看到 IBSRELA 腳本的上漲幅度有多大？您是否將其直接歸因於擴大銷售團隊的線上化而不是其他因素？因為這支隊伍的每一位成員現在都已經接受過全面訓練並部署到位。還有一個後續問題。

Sure. Let me just briefly address the first question, and I'll ask Eric to comment on it, too, is in Eric's comments, you heard him say that we're beginning to see some impact from those who came on early in the expansion, but likely not the majority that came on and are now in the field and train.

當然。讓我簡單回答第一個問題，我也請艾瑞克對此發表評論，在艾瑞克的評論中，您聽到他說，我們開始看到那些在擴張初期加入的人產生了一些影響，但可能不是大多數現在在現場接受訓練的人。

So Eric, any color you want to add to that?

那麼 Eric，你想添加什麼顏色嗎？

No, I think that's right. We started the expansion a little bit earlier in the year, and we certainly have seen impact from those individuals that have come up. And that's what gives me confidence as we move forward now having a full team in place, completely trained and in the field. So plenty of opportunity that's out there and looking forward to having a full team in place for fourth quarter.

不，我認為是這樣。我們在今年早些時候就開始了擴張，我們確實看到了那些新成員帶來的影響。這讓我對未來充滿信心，因為我們現在已經擁有一支完整的、經過全面訓練的、在現場工作的團隊。所以，這裡有很多機會，我期待在第四季度擁有一支完整的團隊。

Fantastic. And just a quick follow-up. Do you have any updates on partnerships in Europe or Rest of the World for XPHOZAH or a time line with more resolution on the approval of the Chinese market.

極好的。接下來是快速的跟進。您是否能揭露 XPHOZAH 在歐洲或世界其他地區的合作夥伴關係的最新進展，或有關中國市場批准的更明確時間表？

Yeah. So for the Chinese approval, we still anticipate that will be before the end of the year. And no updates or news on other partnering.

是的。因此，對於中國方面的批准，我們仍然預計將在今年年底前完成。並且沒有關於其他合作的更新或訊息。

Ed Arce, HC Wainwright.

埃德阿爾斯、HC溫賴特。

This is Thomas asking a couple of questions for Ed. Perhaps first question is for Justin. Can you give the -- can you discuss the latest Bruce and Matt for IBSRELA? And then also, how much improvement can we expect from current level? And what will it take?

這是湯瑪斯向艾德問的幾個問題。也許第一個問題是問賈斯汀的。您能否提供—您能討論一下 Bruce 和 Matt 為 IBSRELA 所做的最新工作嗎？而且，我們可以期待當前水準有多大的提升？這需要什麼呢？

So for IBSRELA, as we've said before, our gross net deduction is around 30%, plus or minus 5%. And so our third quarter was in line with that precisely. And then again, going forward, we'll give updates obviously in the early part of the year as a general premise in the first quarter of 2025, gross center is higher when plans reset insurance policies reset some folks get new coverages and there may be new Medicare rebates taking effect in January '25 as well.

因此對於 IBSRELA，正如我們之前所說，我們的總淨扣除額約為 30%，正負 5%。因此，我們的第三季恰恰符合這一點。然後再次展望未來，我們顯然會在年初提供更新，作為 2025 年第一季的一般前提，當計劃重置、保險政策重置、一些人獲得新的保險範圍時，毛中心會更高，並且新的醫療保險退款也可能會於 2025 年 1 月生效。

Got it. And then I guess for XPHOZAH, you mentioned earlier, IBSRELA sales guidance kind of expected in early next year. Can you also expect slow the sales guide for next year around the same time frame?

知道了。然後我想對於您之前提到的 XPHOZAH，IBSRELA 的銷售指引預計在明年年初。您是否也能預期明年的銷售指南也會在同一時間內放緩？

Well, with all the moving parts of XPHOZAH, I think it would be premature for me to say when we would give guidance. It would be nice to have steady state predictable things. So if we're able to, we'll do as soon as we can, but I think expecting it at the beginning of next year, maybe a little bit premature.

好吧，考慮到 XPHOZAH 的所有活動部件，我認為現在說我們何時會提供指導還為時過早。如果事情能夠保持穩定並可預測那就太好了。因此，如果我們能夠的話，我們會盡快這樣做，但我認為預計在明年年初可能有點為時過早。

Got it. And then one final question, perhaps this one is for Eric. You mentioned earlier in the call you're really seeing early impacts especially from the sales rep that are earlier on in the expansion process. What metrics can we focus on the near and long-term and what we consider to be a successful expansion?

知道了。最後一個問題，也許是問艾瑞克的。您早些時候在電話中提到，您確實看到了早期的影響，尤其是來自擴展過程早期的銷售代表的影響。我們可以關注哪些短期和長期指標以及我們認為成功的擴張是什麼？

Yeah. So for me, what I look at is with the increased individuals in the field, they continue to have an increase in their call activity. We certainly are seeing that simply, which is having more representatives out there in the field. I'm very proud of the team this year to be able to show an increase in new and new and total riders as well as new and total refill prescription.

是的。所以對我來說，我所看到的是，隨著該領域的個人數量增加，他們的呼叫活動也持續增加。我們確實看到了這一點，那就是在該領域擁有更多的代表。我為今年的團隊感到非常自豪，新騎士數量和總騎士數量以及新補充處方和總補充處方數量都有所增加。

So for me, those are the indicators that we're focused on, and we've shown good growth this quarter versus last quarter, so continuing to have that solid quarter-over-quarter growth.

所以對我來說，這些都是我們關注的指標，與上一季相比，本季我們表現出了良好的成長，因此繼續保持穩健的環比成長。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭、拉登堡塔爾曼。

Congrats on the really strong quarter. Just to dig in a little bit more to what you're seeing or what you're hearing in terms of the progress and moving forward with the Kidney Care Act. Any detail you can share on what you're hearing on the legislative front?

恭喜您本季業績表現強勁。我想更深入地了解您所看到或聽到的有關《腎臟保健法》的進展和推進的情況。您能分享一下在立法方面所聽到的任何細節嗎？

Yeah. I mean, if you do what I do and watch congress.gov, you can see all the cosponsors that are signing up in the house, right? As I said in my opening statement, we now have 38, 2 in the companion bill in the Senate. So it is progress and exciting progress at that plus all of the coalition has been built around the patient act.

是的。我的意思是，如果你像我一樣關注 congress.gov，你就可以看到所有在眾議院簽署的共同提案人，對嗎？正如我在開場陳述中所說，我們現在有 38 票贊成、2 票反對參議院的配套法案。所以這是一個進步，而且是令人興奮的進步，而且整個聯盟都是圍繞著患者法案建立的。

So it is we're punching above our weight class. I don't know what other kind of analogies that you can use or metaphors, but we have a lot of attention. Now our system needs to work to get the bill approved in the past.

所以，我們正在發揮超越自己能力水準的作用。我不知道您還可以使用什麼其他的類比或隱喻，但我們非常關注。現在我們的系統需要努力確保該法案獲得批准。

That's good. And then with respect to the APA lawsuit and CMS, are there any specific time lines that the court asked to get back to you and with respect to issuing a potential preliminary injunction?

那挺好的。然後關於 APA 訴訟和 CMS，法院是否要求在特定的時間內回覆您，以及是否發布潛在的初步禁令？

Yeah. I mean, so that needs to occur before the end of the year. So that's why we're hopeful that we will all know something before that.

是的。我的意思是，這需要在年底之前完成。所以我們希望我們都能在此之前了解一些事情。

Okay. The court must decide by the end of the year.

好的。法院必須在年底前做出裁決。

Yes.

是的。

Okay, okay. And then, I guess, lastly on XPHOZAH, I guess, you guys recently, I guess, got back from the ASN meeting. Any feedback that you're hearing from doctors out there with respect to how they're utilizing XPHOZAH right now in the -- to treat their patients.

好的，好的。最後，關於 XPHOZAH，我想，你們最近剛從 ASN 會議回來。您從醫生那裡聽到關於他們目前如何使用 XPHOZAH 治療患者的任何回饋。

Yeah, thanks for that. Listen, I was incredibly impressed with the team this year at ASN. And in talking with physicians, they're using it on label in addition to the binders, and they're really seeing significant results with these patients out there that aren't well managed on their phosphate binders. So it continues to give me confidence in the direction that we're headed and most importantly, the opportunity in front of us.

是的，謝謝。聽著，今年 ASN 的團隊給我留下了深刻的印象。在與醫生交談時，他們除了使用黏合劑外，還在標籤上使用它，並且他們確實看到了那些磷酸鹽黏合劑管理不佳的患者獲得顯著的效果。因此，它繼續讓我對我們前進的方向充滿信心，最重要的是，對我們面前的機會充滿信心。

Chris Raymond, Piper Sandler.

克里斯雷蒙德、派珀桑德勒。

I know this question has been asked a couple of ways already, and I know you're not guiding on XPHOZAH. And Mike, I heard what you said about your messaging to nephrologists to just keep doing what you're doing. But I have to ask, if 60% of your patient base is likely to not be covered come January 1, again, without any legislative or legal progress on your part, how do docs not start to pull back use?

我知道這個問題已經被問過好幾次了，而且我知道你沒有指導 XPHOZAH。麥克，我聽到了你對腎臟科醫師說的話，讓他們繼續做你正在做的事情。但我不得不問，如果到 1 月 1 日，你們 60% 的患者可能都無法獲得保障，同樣，在你們方面沒有任何立法或法律進展的情況下，醫生們怎麼還不開始減少使用呢？

And in particular, I think there could be an argument for this we did -- okay. I'll call earlier this month where the KOL was kind of resisting the notion that there would be a bifurcated treatment that they had find a way to get to keep patients on therapy. And I'm kind of flexed as to how that could be. Any sort of thinking there that you could help maybe align in?

特別是，我認為我們這樣做是有爭議的——好的。本月初我曾打過電話，當時 KOL 有點反對分叉治療的想法，他們必須找到一種方法讓患者繼續接受治療。我對這怎麼可能實現還有些困惑。有什麼想法可以幫忙嗎？

Very simply, this is about access, not reimbursement. So what does that mean is if you, as a nephrologist continue doing what you're doing and you send prescriptions into our ArdelyxAssist, it will be adjudicated whether or not it is a prescription that has reimbursement. And if it doesn't, you're -- as it is today, your patient will be able to potentially meet the benefit requirements of our patient assistance program.

很簡單，這關乎存取權，而非報銷。那麼，這意味著如果您作為腎臟科醫生繼續做您正在做的事情，並將處方發送到我們的 ArdelyxAssist，我們將裁定該處方是否可以報銷。如果沒有，那麼就像今天一樣，您的患者將有可能滿足我們的患者援助計劃的福利要求。

So the objective, as I said in my opening statement was that our objective is to make sure our patients have access to the drugs that we've created. And that's why the message to nephrologist is keep doing what you're doing. We don't anticipate or expect them to determine and bifurcate. That's absolutely what we're trying to avoid. That's not their job.

因此，正如我在開場白中所說，我們的目標是確保我們的患者能夠獲得我們開發的藥物。這就是為什麼我們要向腎臟科醫生傳達的訊息是，繼續做你正在做的事情。我們不預期或期望它們會確定和分叉。這絕對是我們試圖避免的。這不是他們的工作。

Let us do it on the back end with ArdelyxAssist and identify those that still have reimbursement. And for those that qualify, they could have access to the patient systems program.

讓我們使用 ArdelyxAssist 在後端進行此操作並識別那些仍有報銷的人。對於符合條件的患者，他們可以存取患者係統程式。

Okay. So then the way it would show up then, I guess, on the P&L would be, again, barring any sort of progress on all the efforts that you guys have would just be this large free drug expense? Is that a fair statement?

好的。那麼，我猜，它在損益表中的顯示方式將是，再一次，除非你們的所有努力取得任何進展，否則就只是這筆巨額的免費藥品費用？這是一個公正的說法嗎？

There would be a free drug expense in marketing as there is now.

就像現在一樣，行銷會有免費的藥品費用。

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

我們的問答環節到此結束。我想將會議交還給總裁兼執行長 Mike Raab)，請他作最後發言。

And thank you, everyone, for joining us this evening. As always, we remain focused on our priorities, and we'll provide information updates when we can. In the meantime, we remain steadfast in our commitment to patients and to maintaining our commercial momentum.

感謝大家今晚參加我們的活動。像往常一樣，我們將繼續專注於我們的優先事項，並將在可能的情況下提供資訊更新。同時，我們仍然堅定不移地履行對患者的承諾並保持我們的商業發展勢頭。

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

這樣我們就可以結束通話了。謝謝您，接線生。