Ardelyx Inc (ARDX) 2023 Q4 法說會逐字稿

(audio in progress) and welcome to the Ardelyx fourth-quarter and full year 2023 financial results conference call. (Operator Instructions) Please note this event is being recorded.

（音訊正在進行中）歡迎參加 Ardelyx 第四季和 2023 年全年財務業績電話會議。（操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Caitlin Lowie, Vice President of Corporate Communications and Investor Relations at Ardelyx. Please go ahead.

我現在想將會議交給 Ardelyx 企業傳播和投資者關係副總裁 Caitlin Lowie。請繼續。

Thank you. Good afternoon and welcome to our fourth-quarter and full year 2023 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 2023 年第四季和全年財務業績電話會議。在本次電話會議中，我們將參考今天稍早發布的新聞稿，該新聞稿可在該公司網站 ardelyx.com 的投資者部分取得。

During this call, we will be making forward-looking statements that are subject to risk and uncertainty. Our actual results may differ materially from those described. We encourage you to review the risk factors and our most recent annual report on Form 10-K that was filed today. It 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描述的結果有重大差異。我們鼓勵您查看風險因素以及我們今天提交的 10-K 表中的最新年度報告。您可以在我們的網站 ardelyx.com 上找到它。雖然我們可能選擇在未來更新這些前瞻性陳述，但我們特別聲明不承擔任何這樣做的義務，即使我們的觀點改變。

Our President and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's progress during the fourth quarter of 2023 and the full year 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the performance of IBSRELA and XPHOZAH. Our Chief Medical Officer, Dr. Laura Williams, will then discuss and expose a real-world evidence study announced today. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's performance during the fourth quarter and full year ended December 31, 2023, 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 2023 年第四季和 2023 年全年的進展。接下來，首席商務官 Susan Rodriguez 將提供 IBSRELA 和 XPHOZAH 業績的最新資訊。我們的首席醫療官勞拉威廉斯博士隨後將討論並揭露今天宣布的一項真實世界證據研究。財務和營運長賈斯汀·倫茨 (Justin Renz) 將在今天準備好的演講結束時回顧公司截至 2023 年 12 月 31 日的第四季度和全年業績，然後再開始提問。

With that, let me pass the call over to Mike. Good afternoon, everyone, and thank you for joining us on the call. I feel like I've said this every quarter, but we are really excited to be here to discuss our progress and performance.

接下來，讓我把電話轉給麥克。大家下午好，感謝您加入我們的電話會議。我覺得我每季都會這麼說，但我們真的很高興能在這裡討論我們的進展和績效。

The fourth quarter was significant, as was all of 2023, as we continue our evolution as an integrated biotech company, bringing two first-in-class products to patients. IBSRELA and XPHOZAH are demonstrating favorable market response with high healthcare practitioner interest and continuously expanding adoption.

第四季和 2023 年全年一樣意義重大，我們作為一家綜合生物技術公司繼續發展，為患者帶來了兩種一流的產品。IBSRELA 和 XPHOZAH 表現出良好的市場反應，醫療保健從業者對此表現出濃厚的興趣，並不斷擴大採用範圍。

In November of last year, we launched XPHOZAH, and the market response, both in terms of treatment uptake and direct feedback we received from the field, has validated what has always been clear to us, that physicians and patients have been waiting for a novel mechanism option to help control serum phosphorus.

去年 11 月，我們推出了 XPHOZAH，市場反應，無論是治療採用率還是我們從現場收到的直接反饋，都證實了我們一直很清楚的一點：醫生和患者一直在等待一種新的藥物有幫助於控制血清磷的機制選擇。

As you will hear from Susan, all the indicators we track early in launch point to a strong uptake. Additionally, as we announced today, as part of our commitment to continually build our understanding of the clinical utility of our products, we are conducting a real-world evidence study designed to capture the impact that an XPHOZAH-based regimen can have on the treatment of hyperphosphatemia. Laura will review more details about the study during our call today.

正如您將從蘇珊那裡聽到的那樣，我們在發布初期跟踪的所有指標都表明了強勁的採用。此外，正如我們今天所宣布的那樣，作為我們不斷加深對產品臨床效用的理解的承諾的一部分，我們正在進行一項真實世界的證據研究，旨在捕捉基於 XPHOZAH 的方案對治療的影響高磷血症。勞拉將在今天的電話會議上回顧有關該研究的更多細節。

Turning to IBSRELA, in January, we shared our enthusiasm for our commercial progress we are making and that our expectations for IBSRELA are high. We shared that we believe IBSRELA has the potential to become a billion-dollar drug. The patients are there, they need relief, and many of them continue to experience symptoms despite treatment with incumbent therapies, clearly reinforcing the need for novel treatment options like IBSRELA.

談到 IBSRELA，一月份，我們分享了對我們正在取得的商業進展的熱情，以及我們對 IBSRELA 的期望很高。我們認為 IBSRELA 有潛力成為一種價值十億美元的藥物。患者就在那裡，他們需要緩解，儘管使用現有療法進行治療，但其中許多人仍然出現症狀，這顯然加強了對 IBSRELA 等新型治療方案的需求。

IBSRELA's mechanism of action, solid clinical data, and a growing user base of positive experience is resonating, driving expanding consideration and adoption by more and more healthcare practitioners. With patients' positive experiences with IBSRELA, HCPs are beginning to change how they engage with and treat their IBS-C patients as they are expanding their use of the therapy.

IBSRELA 的作用機制、可靠的臨床數據以及不斷增長的積極體驗用戶群引起了共鳴，推動了越來越多的醫療保健從業者的考慮和採用。隨著患者對 IBSRELA 的積極體驗，HCP 開始改變他們與 IBS-C 患者接觸和治療的方式，同時擴大療法的使用。

In addition, the path for access is established. These are the fundamentals of our commercial strategy, and they are working. As we noted in January, we will always look to expand the opportunity and to ensure our medicines get to those patients who need it. Thus, we are thoughtfully investing in expanding our commercial reach.

此外，也建立了存取路徑。這些是我們商業策略的基礎，而且它們正在發揮作用。正如我們在一月份指出的那樣，我們將始終尋求擴大機會並確保我們的藥物到達那些需要它的患者手中。因此，我們正在深思熟慮地投資擴大我們的商業範圍。

We are also thinking about what the future of Ardelyx will look like, and we find ourselves in a unique and enviable position. We have options. With both XPHOZAH and IBSRELA approved in the US and doing well, we are engaging potential international partners to bring these products to patients in other global markets.

我們也在思考 Ardelyx 的未來會是什麼樣子，我們發現自己處於一個獨特且令人羨慕的位置。我們有選擇。XPHOZAH 和 IBSRELA 都已在美國獲得批准且表現良好，我們正在與潛在的國際合作夥伴合作，將這些產品帶給全球其他市場的患者。

In addition, with our established and proven commercial organization, we are merging as a partner of choice for development-stage assets in therapeutic areas where patients continue to have unmet needs. And with our successful track record of discovery, development, and regulatory approvals, we also have the opportunity to develop earlier-stage assets ourselves.

此外，憑藉我們成熟且經過驗證的商業組織，我們正在合併成為患者需求仍未得到滿足的治療領域開發階段資產的首選合作夥伴。憑藉我們在發現、開發和監管批准方面的成功記錄，我們還有機會自行開發早期資產。

These activities are ongoing, and we look forward to sharing more information when appropriate. In the meantime, our top priority is to focus on sustaining the commercial momentum of IBSRELA and XPHOZAH.

這些活動正在進行中，我們期待在適當的時候分享更多資訊。同時，我們的首要任務是專注於維持 IBSRELA 和 XPHOZAH 的商業動能。

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

我現在將電話轉給蘇珊，分享我們商業表現的最新情況。蘇珊？

Thank you, Mike. It is great to be here today to share a commercial update on both IBSRELA and XPHOZAH. Let me start with IBSRELA.

謝謝你，麥克。很高興今天能在這裡分享 IBSRELA 和 XPHOZAH 的商業更新。讓我從 IBSRELA 開始。

IBSRELA has established a unique position within the IBS-C treatment paradigm and is changing the way the HCP community treats patients with IBS-C. HCPs that we have reached with our messaging are responding favorably to the differentiated mechanism of action and clinical data profile, adopting IBSRELA, and continuously expanding their use based on the patient responses they are seeing.

IBSRELA 在 IBS-C 治療範式中確立了獨特的地位，並正在改變 HCP 社區治療 IBS-C 患者的方式。我們透過資訊連結到的 HCP 對差異化的作用機制和臨床數據資料做出了積極的反應，採用了 IBSRELA，並根據他們所看到的患者反應不斷擴大其使用範圍。

Significant opportunity exists to continue to expand awareness, knowledge, and uptake across our target market. Our research has demonstrated that when HCPs become aware of IBSRELA and its first-in-class mechanism, they begin prescribing. And the more they see, hear, and learn about IBSRELA, the more they prescribe and expand their thinking of patients who are candidates for IBSRELA.

我們存在著繼續擴大目標市場意識、知識和吸收的重大機會。我們的研究表明，當 HCP 意識到 IBSRELA 及其一流機制時，他們就會開始處方。他們對 IBSRELA 看到、聽到和了解的越多，他們對 IBSRELA 候選患者的處方和想法就越多。

The fundamentals driving IBSRELA's growth momentum are strong. IBS-C is a condition of multifactorial pathophysiology, and patients need multiple mechanism therapies to improve treatment outcomes and provide additional relief. Prior to the launch of IBSRELA, there was a single class of drugs available for patients with a large unmet need across patients whose symptoms persisted despite treatment with these therapies.

推動 IBSRELA 成長動能的基本面強勁。IBS-C 是一種多因素病理生理學病症，患者需要多種機制療法來改善治療結果並提供額外的緩解。在 IBSRELA 推出之前，只有一類藥物可供大量未滿足需求的患者使用，儘管接受了這些療法的治療，但症狀仍然存在。

IBS-C prescriptions are concentrated across an accessible group of HCPs who have demonstrated to be very responsive to both our field-based sales team as well as our omni-channel digital engagement program. A favorable access profile is established. Interest is high. Response to the IBSRELA profile is driving adoption. Favorable treatment experiences are driving expanded use, which in turn is driving a continuously expanding view of patients who are candidates for IBSRELA therapy.

IBS-C 處方集中在一群可以接觸到的 HCP 中，他們對我們的現場銷售團隊以及我們的全通路數位參與計畫非常敏感。建立有利的存取設定檔。興趣很高。對 IBSRELA 設定檔的回應正在推動採用。良好的治療體驗正在推動使用範圍的擴大，這反過來又推動了對 IBSRELA 治療候選患者的不斷擴大的認識。

We continue to see consistent, persistent growth of IBSRELA across all key performance metrics. New prescriptions are growing. Refill prescriptions are growing. New riders are growing and use across the existing rider base is persistently growing. These foundational elements will be leveraged and built upon as we increase our investment in IBSRELA in 2024. You can expect to see continued steady growth throughout the year.

我們繼續看到 IBSRELA 在所有關鍵績效指標上的持續成長。新處方不斷增加。續配處方正在增加。新的騎手不斷增長，現有騎手基礎的使用量也在持續增長。當我們在 2024 年增加對 IBSRELA 的投資時，將利用並建立這些基本要素。您可以預期全年將持續穩定成長。

Turning to XPHOZAH, at just three months since launch in November, we are very pleased to see the market responding as we anticipated. The high level of awareness, interest, and intent to adopt has translated into strong initial product uptake. The $2.5 million in revenue we reported during the fourth quarter, but really from mid-November through the end of December, validate that there were patients and physicians who were waiting for first-in-class phosphate absorption inhibitor XPHOZAH as a much-needed option for patients who were not able to achieve target serum phosphorus levels with phosphate binders alone or who were intolerant of phosphate binders.

談到 XPHOZAH，自 11 月推出以來僅三個月，我們很高興看到市場的反應符合我們的預期。高度的認知度、興趣和採用意願已轉化為強大的初始產品採用率。我們在第四季度報告的 250 萬美元收入（實際上是從 11 月中旬到 12 月底）證實，有患者和醫生正在等待一流的磷酸鹽吸收抑製劑 XPHOZAH 作為急需的選擇適用於僅使用磷酸鹽結合劑無法達到目標血清磷水平或對磷酸鹽結合劑不耐受的患者。

We are continually hearing from physicians who say that patients who are on an XPHOZAH-based regimen are experiencing positive results. Additionally, patients are responding favorably to the single-tablet, twice-daily dosing profile of XPHOZAH, both when it's being added to their binder regimen or when the HCP chooses to discontinue their binder therapy and initiate treatment with XPHOZAH.

我們不斷聽到醫生說，接受基於 XPHOZAH 的治療方案的患者正在經歷積極的結果。此外，無論是將XPHOZAH 添加到他們的黏合劑治療方案中，還是當HCP 選擇停止其黏合劑治療並開始使用XPHOZAH 治療時，患者都對XPHOZAH 的單片、每日兩次給藥方案反應良好。

In addition to a positive therapeutic response and patient experience reported by physicians, we are rapidly establishing a favorable access landscape for XPHOZAH. Payers are establishing coverage policies which provide access to XPHOZAH via a prior authorization for patients who are not adequately responding to binder therapy or are intolerant of binder therapy.

除了醫生報告的積極治療反應和患者體驗之外，我們正在迅速為 XPHOZAH 建立有利的准入環境。付款人正在製定承保政策，透過事先授權為對黏合劑療法沒有充分反應或不耐受黏合劑療法的患者提供 XPHOZAH 的使用權。

Nephrologists report to us that a large subset of their patients meet these criteria and nephrologists are demonstrating a willingness to engage in the administrative PA process to secure access to therapy for these patients as they believe they are in need of a novel mechanism approach. At this point, we are seeing patients access XPHOZAH across all commercial and government payers. In addition, we are seeing patients take advantage of the resources available through our patient services programs, including our copay pay down program and patient assistance program for qualifying patients.

腎臟病專家向我們報告，他們的很大一部分患者符合這些標準，腎臟專家表示願意參與行政 PA 流程，以確保這些患者獲得治療，因為他們認為他們需要一種新穎的機制方法。目前，我們看到患者透過所有商業和政府付款人造訪 XPHOZAH。此外，我們看到患者利用我們的患者服務計劃提供的資源，包括我們的共付額付款計劃和針對符合條件的患者的患者援助計劃。

Finally, we are also seeing strong market interest and responsiveness to our in-market messaging centered on the novel phosphate blocking mechanism and clinical profile of XPHOZAH. Our XPHOZAH-dedicated sales force of 60 are finding nephrology offices across the country welcoming and eager to learn more. Our digital and in-person educational sessions are highly attended, and our various omni-channel digital communications are seeing high levels of engagement. These are all positive launch indicators that we believe will result in continued, consistent, and persistent uptake.

最後，我們也看到了市場對我們以 XPHOZAH 的新型磷酸鹽阻斷機制和臨床概況為中心的市場資訊的強烈興趣和反應。我們的 60 位 XPHOZAH 銷售團隊發現全國各地的腎臟科辦事處都很歡迎我們，並渴望了解更多資訊。我們的數位和麵對面的教育課程出席率很高，我們的各種全通路數位通訊也得到了很高的參與度。這些都是正面的啟動指標，我們相信這些指標將帶來持續、一致和持久的採用。

The foundational elements of the Ardelyx commercial approach are all working together and we are incredibly pleased with the performance thus far. What we see is consistent and persistent growth driven by the market need, favorable market access, and key demand creation fundamentals that are delivering on the mission of Ardelyx to bring a novel mechanism therapy to patients who, despite treatment with available therapies, are in great need of a new option.

Ardelyx 商業方法的基本要素都在協同工作，我們對迄今為止的表現非常滿意。我們看到的是由市場需求、有利的市場准入和關鍵的需求創造基本面驅動的持續增長，這些基本面正在履行Ardelyx 的使命，即為儘管接受現有療法治療但仍處於良好狀態的患者帶來一種新穎的機制療法。需要一個新的選擇。

It is an exciting time for our team and for Ardelyx. The growth momentum we are seeing for both IBSRELA and XPHOZAH is exciting. The team is laser focused on sustaining this momentum with the strategic intent to reach all patients in need of our first-in-class therapies.

對於我們的團隊和 Ardelyx 來說，這是一個令人興奮的時刻。我們看到 IBSRELA 和 XPHOZAH 的成長勢頭令人興奮。團隊專注於維持這一勢頭，其戰略意圖是惠及所有需要我們一流療法的患者。

I look forward to continuing to share updates with you in the future. With that, I will hand it to Laura.

我期待將來繼續與您分享最新動態。這樣，我就把它交給蘿拉。

Thank you, Susan. I'm really pleased to join you today. In addition to all the great work that Susan shared with you in support of IBSRELA and XPHOZAH, we also continue to expand our medical and clinical understanding of our products. Medical education for patients and HCPs, as well as data dissemination via abstract presentations and publications, continue to provide valuable insight and enhance the science around our products and, more generally, within these therapeutic areas, which brings me to one of the data gathering programs that I'm extremely excited about.

謝謝你，蘇珊。我很高興今天能加入你們的行列。除了 Susan 與您分享的支援 IBSRELA 和 XPHOZAH 的所有出色工作外，我們還繼續擴大對我們產品的醫學和臨床了解。對患者和HCP 的醫學教育，以及透過摘要演示和出版物傳播數據，繼續提供有價值的見解並增強圍繞我們產品的科學，更廣泛地說，在這些治療領域內，這讓我參與了其中一項資料收集計劃我對此感到非常興奮。

Today, we announced that we will be initiating a real-world evidence study of XPHOZAH. As we know in clinical development, gaining a real-world understanding of our therapies can vastly increase our knowledge of how these drugs are impacting patients outside of the more controlled clinical setting, complementing our overall understanding of the treatment paradigms for our patients.

今天，我們宣布將啟動 XPHOZAH 的現實世界證據研究。正如我們在臨床開發中所知，獲得對我們的療法的真實理解可以極大地增加我們對這些藥物如何在更受控制的臨床環境之外影響患者的了解，補充我們對患者治療範例的整體理解。

Real-world evidence studies can shine additional light on the safety, tolerability, and effectiveness of a therapy and provide greater insight into epidemiology, disease burden, treatment patterns, treatment adherence, impact on quality of life, and, importantly, how a new drug like XPHOZAH integrates into a patient's lived experience.

真實世界的證據研究可以進一步闡明治療的安全性、耐受性和有效性，並更深入地了解流行病學、疾病負擔、治療模式、治療依從性、對生活品質的影響，以及更重要的是，新藥如何就像 XPHOZAH 融入患者的生活體驗。

We anticipate that these types of data will provide Ardelyx with additional insights to help us support the patient and physician community as they integrate XPHOZAH into their treatment practices. It will also help us develop educational materials for patients to maximize their understanding of the drug and potentially enhance their experience while continuing to highlight the favorable benefit-risk profile of XPHOZAH, and it will also support ongoing discussions with payers.

我們預計這些類型的數據將為 Ardelyx 提供更多見解，幫助我們支持患者和醫生社群將 XPHOZAH 融入他們的治療實踐。它還將幫助我們為患者開發教育材料，以最大限度地提高他們對藥物的了解，並有可能增強他們的體驗，同時繼續強調XPHOZAH 有利的獲益風險概況，並且還將支持與付款人正在進行的討論。

This will be a real-world, long-term, prospective observational cohort study designed to capture the impact of XPHOZAH-based regimens in patients with hyperphosphatemia on maintenance dialysis who were either not controlled on or intolerant of binder therapy. To that end, patients on the XPHOZAH-based regimen will include those who are using XPHOZAH in combination with phosphate binders as well as those who are taking XPHOZAH as monotherapy.

這將是一項真實世界、長期、前瞻性觀察隊列研究，旨在了解基於XPHOZAH 的治療方案對維持性透析的高磷血症患者的影響，這些患者要么無法控制黏合劑治療，要么不能耐受黏合劑治療。為此，接受基於 XPHOZAH 方案的患者將包括那些將 XPHOZAH 與磷酸鹽結合劑聯合使用的患者以及那些將 XPHOZAH 作為單一療法的患者。

We will follow these patients over a period of up to three years to understand the persistence of treatment effectiveness in achieving and maintaining serum phosphors within the guideline-recommended range. This extended analysis period will allow us to also examine changes in treatment patterns, discontinuation rates across treatment regimens, and the impact of an XPHOZAH-based regimen on patient satisfaction.

我們將對這些患者進行長達三年的跟踪，以了解治療效果在實現和維持血清磷在指南建議範圍內的持續性。延長的分析期將使我們能夠檢查治療模式的變化、治療方案的停藥率以及基於 XPHOZAH 的方案對患者滿意度的影響。

I am very excited about what XPHOZAH may be able to do for our patients, and capturing data in a real-world setting will not only supplement the insights we've gained in our clinical trials, but more importantly, will further expand our understanding and enhance our ability to support the patients and the physician communities who are constantly striving to manage serum phosphorous in the setting of end-stage kidney disease.

我對 XPHOZAH 能夠為我們的患者做的事情感到非常興奮，在現實世界中捕獲數據不僅會補充我們在臨床試驗中獲得的見解，更重要的是，將進一步擴大我們的理解和增強我們為患者和醫生團體提供支持的能力，他們不斷努力在終末期腎病的情況下控制血清磷。

I look forward to sharing more detail and results from this trial in the future. I will now pass it to Justin.

我期待將來分享該試驗的更多細節和結果。我現在將其傳遞給賈斯汀。

Thank you, Laura. Earlier in January, we pre-announced our product revenue, so I'll use this as an opportunity to review that material and highlight additional key financials from the fourth quarter in full year 2023. What I believe you will hear from the information we have provided today is we find ourselves in a strong financial position. We are well-resourced, we have multiple revenue streams, and we are thoughtfully investing in continued growth.

謝謝你，勞拉。一月初，我們預先公佈了我們的產品收入，因此我將藉此機會回顧資料並重點介紹 2023 年第四季的其他關鍵財務數據。我相信您將從我們今天提供的資訊中聽到的是，我們發現我們的財務狀況強勁。我們資源充足，擁有多種收入來源，並且正在深思熟慮地投資於持續成長。

We have total revenues of $34.4 million in the fourth quarter of 2023, driven by growth in net product sales revenue. On a full-year basis, we reported total revenues of $124.5 million in 2023, compared to $52.2 million in 2022. Our significant year-over-year growth was driven primarily by the strong performance of IBSRELA.

在淨產品銷售收入成長的推動下，2023 年第四季我們的總營收為 3,440 萬美元。從全年來看，我們報告 2023 年的總收入為 1.245 億美元，而 2022 年為 5,220 萬美元。我們的年比顯著成長主要是由 IBSRELA 的強勁表​​現所推動的。

I will now take a moment to walk through the relative contributions of our revenue components during the fourth quarter and full year. First, we had US net product sales revenue of IBSRELA in the quarter ended December 31, 2023, of $28.1 million, a 26% quarter-over-quarter increase from the $22.3 million we reported in the third quarter. On an annual basis, we recorded $80.1 million of IBSRELA US net product sales revenue in 2023, compared to $15.6 million in 2022, as a result of consistent and persistent growth in all key metrics.

我現在將花點時間介紹第四季度和全年我們收入組成部分的相對貢獻。首先，截至 2023 年 12 月 31 日的季度，IBSRELA 在美國的產品淨銷售收入為 2,810 萬美元，比我們第三季報告的 2,230 萬美元成長了 26%。以年度計算，由於所有關鍵指標持續成長，我們在 2023 年的 IBSRELA 美國產品淨銷售收入為 8,010 萬美元，而 2022 年為 1,560 萬美元。

We also reported $2.5 million in US net product sales revenue of XPHOZAH in the fourth quarter following the launch in November. Second, we reported $3 million in licensing revenue in the fourth quarter, bringing our full-year licensing revenue total to $35.8 million, which is comparable to the $35 million in licensing revenue that we recognized in 2022. Finally, we reported product supply revenue of approximately $800,000 in the fourth quarter and $6.1 million for the full year of 2023, compared to $1.5 million during the full year of 2022.

我們也報告了 XPHOZAH 在 11 月推出後第四季在美國的產品淨銷售收入為 250 萬美元。其次，我們報告第四季度的授權收入為 300 萬美元，使我們的全年授權收入總額達到 3,580 萬美元，這與我們在 2022 年確認的 3,500 萬美元的授權收入相當。最後，我們報告第四季的產品供應收入約為 80 萬美元，2023 年全年的產品供應收入為 610 萬美元，而 2022 年全年的產品供應收入為 150 萬美元。

Research and development expenses were $9.5 million in the fourth quarter of 2023, compared to $9.1 million for the same quarter of 2022. In 2023 and 2022, R&D expenses were $35.5 million and $35.2 million, respectively.

2023 年第四季的研發費用為 950 萬美元，而 2022 年第四季的研發費用為 910 萬美元。2023年及2022年，研發費用分別為3,550萬美元及3,520萬美元。

Selling, general, and administrative expenses were $47.7 million in the fourth quarter of 2023, an increase of $28 million from the $19.7 million we reported for the same period of 2022. The increase was due to the costs associated with the continued commercialization and growth of IBSRELA, as well as the launch activities for XPHOZAH. On a full-year basis, total SG&A expenses were $134.4 million, compared to $76.6 million in 2022.

2023 年第四季的銷售、一般和管理費用為 4,770 萬美元，比我們報告的 2022 年同期的 1,970 萬美元增加了 2,800 萬美元。這一增長是由於 IBSRELA 的持續商業化和增長以及 XPHOZAH 的推出活動相關的成本。以全年計算，SG&A 支出總額為 1.344 億美元，而 2022 年為 7,660 萬美元。

We had a net loss of approximately $28.8 million, or $0.12 per share, in the fourth quarter of 2023, compared to net income of $10.7 million, or $0.06 per fully diluted share in the same period of 2022. The net loss for the fourth quarter of 2023 includes $5 million in combined non-cash expenses from share-based compensation and non-cash interest expense related to the sale of future royalties.

2023 年第四季度，我們的淨虧損約為 2,880 萬美元，即每股 0.12 美元，而 2022 年同期的淨利潤為 1,070 萬美元，即每股完全稀釋後的每股 0.06 美元。2023 年第四季的淨虧損包括來自股權激勵的 500 萬美元的合併非現金支出以及與出售未來特許權使用費相關的非現金利息支出。

Our net loss for the full year 2023 was $66.1 million, or $0.30 per share, which included $17.9 million of non-cash expenses from share-based compensation, non-cash interest expense related to the sale of future royalties, and impairment of a right of lease use asset. In 2022, we reported a net loss of $67.2 million, or $0.42 per share, for the full year.

我們 2023 年全年的淨虧損為 6,610 萬美元，即每股 0.30 美元，其中包括來自股權激勵的 1,790 萬美元非現金支出、與出售未來特許權使用費相關的非現金利息支出以及權利減損租賃使用資產。2022 年，我們報告全年淨虧損 6,720 萬美元，即每股 0.42 美元。

As of December 31, 2023, we had total cash, cash equivalents, and short-term investments of $184.3 million, as compared to $123.9 million at the end of 2022. This includes $22.4 million in net proceeds that we drew in mid-October from our term loan agreement with SLR Capital, which we announced following the approval of XPHOZAH.

截至 2023 年 12 月 31 日，我們的現金、現金等價物及短期投資總額為 1.843 億美元，而 2022 年底為 1.239 億美元。這包括我們在 10 月中旬從與 SLR Capital 的定期貸款協議中提取的 2,240 萬美元淨收益，該協議是我們在 XPHOZAH 批准後宣布的。

In addition to our cash as of December 31, 2023, in January, we received a $3 million milestone payment from Fosun Pharma following the US approval of XPHOZAH. We also intend to draw the next $50 million tranche from our term loan agreement with SLR prior to the expiry of this option on March 15, 2024.

除了截至 2023 年 12 月 31 日的現金外，1 月份，XPHOZAH 在美國獲得批准後，我們還收到了復星醫藥的 300 萬美元里程碑付款。我們還打算在 2024 年 3 月 15 日該選項到期之前，從與 SLR 的定期貸款協議中提取下一筆 5000 萬美元。

Now, let me take a few minutes to give you some insights into what we currently expect for 2024. First, as it relates to IBSRELA, our strong performance in 2023 was driven by consistent uptake for IBSRELA across each of our key measures, including new riders and repeat riders, as well as new and repealed prescriptions. IBSRELA's performance to date and, as Susan shared earlier, the continued insight from our infield experience has strengthened our confidence in the potential for this product. As a result, in January, we announced we currently expect IBSRELA's US net product sales revenue for the full year 2024 to be between $140 million and $150 million. As a reminder, our guidance does not include any anticipated XPHOZAH, partner milestone payments, or product supply revenues.

現在，讓我花幾分鐘時間向您介紹我們目前對 2024 年的預期。首先，就 IBSRELA 而言，我們 2023 年的強勁表現是由於我們每項關鍵指標（包括新附加險和重複附加險，以及新處方和廢止處方）對 IBSRELA 的持續採用。IBSRELA 迄今為止的表現，以及正如 Susan 之前分享的那樣，我們從現場經驗中獲得的持續洞察增強了我們對該產品潛力的信心。因此，我們在 1 月宣布，目前預計 IBSRELA 2024 年全年的美國產品淨銷售收入將在 1.4 億美元至 1.5 億美元之間。提醒一下，我們的指導不包括任何預期的 XPHOZAH、合作夥伴里程碑付款或產品供應收入。

As we have continually done since the launch of IBSRELA, we have thoughtfully increased our investment as our internal expectations evolved. We began additional planned investments into our sales and marketing in January, including the expansion of our field presence from 64 to 124 dedicated to IBSRELA, as well as increasing our spending in marketing initiatives, including additional engagement, product sampling, and our patient support services. As a result, by the third quarter of 2024, we anticipate incurring incremental operating expenses, averaging approximately $20 million more per quarter when compared to our fourth quarter of 2023.

正如我們自 IBSRELA 推出以來不斷所做的那樣，隨著我們內部期望的變化，我們深思熟慮地增加了投資。我們從一月開始對銷售和行銷進行額外的計劃投資，包括將我們專門用於IBSRELA 的現場服務從64 個擴大到124 個，以及增加我們在行銷計劃上的支出，包括額外的參與、產品抽樣和病患支援服務。因此，到 2024 年第三季度，我們預計會產生增量營運費用，與 2023 年第四季相比，每季平均增加約 2,000 萬美元。

We feel confident that our current cash position will support our expected spend, including these investments. We are excited about IBSRELA's performance, the early days of XPHOZAH, and the strength of our cash position. We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value.

我們相信，我們目前的現金狀況將支持我們的預期支出，包括這些投資。我們對 IBSRELA 的表現、XPHOZAH 的早期發展以及我們的現金狀況感到興奮。我們將繼續深思熟慮如何配置資本，同時專注於股東價值最大化。

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

說完，我會把它交還給麥克。

Thanks, Justin. We accomplished a lot in 2023, and we're not yet done, and we're not looking back. 2024 is going to be yet another important and exciting year for Ardelyx. We are looking ahead, and our team is more aligned than ever on the company's path forward.

謝謝，賈斯汀。2023 年我們取得了許多成就，但我們尚未完成，我們不會回頭。對 Ardelyx 來說，2024 年將是另一個重要且令人興奮的一年。我們放眼未來，我們的團隊比以往任何時候都更加堅定地致力於公司的前進道路。

I will now open the call to questions. Danielle?

我現在開始提問。丹妮爾？

We will now begin the question-and-answer session. (Operator Instructions) Dennis Ding, Jefferies.

我們現在開始問答環節。（操作員說明）Dennis Ding，Jefferies。

Hi. Thanks for taking our questions, and congratulations on all the progress. So, two questions for me. For XPHOZAH's growth to net, can you remind us your guidance on that and the various pushes and pulls that could take place in Q1, given you guys have made some comments on things like co-pay assistance and patient assistance programs?

你好。感謝您提出我們的問題，並祝賀所有的進展。那麼，有兩個問題問我。對於 XPHOZAH 的淨增長，考慮到您對共同支付援助和患者援助計劃等問題發表了一些評論，您能否提醒我們您對此的指導以及第一季度可能發生的各種推動和拉動？

And then question number two is also on XPHOZAH, but around HR 5074. I appreciate this is sort of out of your control, but can you elaborate on some of the different scenarios that could come out of this and that you're confident in your ability to manage the business in each of these scenarios? Thank you.

第二個問題也在 XPHOZAH 上，但大約在 HR 5074 左右。我知道這有點超出您的控制範圍，但是您能否詳細說明可能會出現的一些不同場景，以及您對自己在每種場景中管理業務的能力充滿信心嗎？謝謝。

Sure, Dennis. Let me address the second question first, and then I'll pass it off to Justin for some discussion on growth to net.

當然，丹尼斯。讓我先解決第二個問題，然後我會將其轉交給賈斯汀，以討論淨成長問題。

You hit the nail on the head. We can't predict what's going to happen in Washington. We're very confident with the approach that we're taking in the business with XPHOZAH, and obviously continue to monitor and participate as much as is practicable in what's trying to be accomplished in DC.

你擊中了要害。我們無法預測華盛頓會發生什麼事。我們對與 XPHOZAH 開展業務所採取的方法非常有信心，並且顯然會繼續盡可能地監控和參與 DC 試圖實現的目標。

Obviously, the broader questions there in terms of the continued resolution, the government functioning is what the priority is there in DC, and we will continue to update you and everyone else as when anything changes with the work that's being done there.

顯然，在持續解決方面更廣泛的問題、政府運作是華盛頓特區的首要任務，當那裡正在進行的工作發生任何變化時，我們將繼續向您和其他人通報最新情況。

Justin?

賈斯汀？

Thanks, Mike. Hi, Dennis. So for the fourth quarter, our growth to net deduction was in line with our expectations at approximately 21%. Generally speaking, at this stage, it's too early to tell what we can expect with any high level of specificity or detail.

謝謝，麥克。嗨，丹尼斯。因此，第四季的淨扣除額成長符合我們的預期，約為 21%。一般來說，在現階段，現在判斷我們可以預期什麼高水準的特異性或細節還為時過早。

What we can say is, generally speaking, we expect that we may see a higher percentage of XPHOZAH patients on Medicare compared to IBSRELA. So due to the government segment rebate dynamics, we expect that the growth to net deduction may be slightly unfavorable for XPHOZAH compared to IBSRELA when it's somewhat early, and of course, we haven't really experienced the seasonality yet because it's obviously the first time we've watched and started selling XPHOZAH in the first quarter of the calendar year.

我們可以說的是，一般來說，我們預期與 IBSRELA 相比，參加 Medicare 的 XPHOZAH 患者的比例可能會更高。因此，由於政府部門的回扣動態，我們預計，與IBSRELA 相比，XPHOZAH 的淨扣除成長可能稍微不利，因為現在還為時過早，當然，我們還沒有真正經歷過季節性，因為這顯然是第一次我們在今年第一季觀察並開始販售 XPHOZAH。

Chris Raymond, Piper Sandler.

克里斯·雷蒙德，派珀·桑德勒。

Hey, thanks, and congrats from us, too, on the progress. Maybe two questions, and they're both on XPHOZAH. So, just on this three-year observational study, at least in terms of the [SPIRX] data that we get, and I know you guys get that, too, intent to prescribe is really robust. Awareness, almost universal, and there's just a ton of evidence that doctors, at least initially, you're very satisfied with the drug, and it seems like the pinch point really is access, as you might expect right now. So, I guess the question is, maybe what commercial itch does this trial scratch with that kind of reception you've already had, or is there a regulatory commitment that this fulfills? And then I've got a follow-up.

嘿，謝謝，我們也祝賀你們取得的進展。也許有兩個問題，它們都在 XPHOZAH 上。因此，就這項為期三年的觀察性研究而言，至少就我們獲得的 [SPIRX] 數據而言，我知道你們也明白，開處方的意圖非常強勁。意識幾乎是普遍的，並且有大量證據表明醫生，至少在最初，您對這種藥物非常滿意，而且似乎關鍵點確實是可及性，正如您現在所期望的那樣。所以，我想問題是，也許這個試驗會在你已經獲得的這種接待中觸及什麼商業渴望，或者這是否履行了監管承諾？然後我有一個後續行動。

Yeah, and let me just quickly address that, and then I'll pass on to Laura for any other comments. No regulatory commitment for this. This is, as Laura said in her comments, our continued commitment to understanding the clinical utility and where and how a product like XPHOZAH can be used. And it's certainly curiosity, but it's also understanding that as this continues to grow, there's going to be questions and thoughts from payers and others that we want to be prepared to answer, and the only time to start is before you get those questions. So, it's better to have these data than not, and it has as much to do with our belief in the clinical utility and capturing the data, demonstrating that.

是的，讓我快速解決這個問題，然後我將轉給勞拉徵求任何其他意見。對此沒有監管承諾。正如 Laura 在她的評論中所說，這是我們對了解臨床效用以及如何使用 XPHOZAH 這樣的產品的持續承諾。這當然是好奇心，但也理解，隨著這種情況的持續增長，付款人和其他人將會提出問題和想法，我們希望準備好回答，而唯一開始的時間是在你收到這些問題之前。因此，擁有這些數據總比沒有好，這與我們對臨床效用的信念以及捕獲數據並證明這一點有很大關係。

Laura, anything to add?

蘿拉，有什麼要補充的嗎？

Yeah, Mike, I think the only other piece to add is, again, this, as you said, no regulatory commitment. This really reflects our desire to better understand the impact that a drug like XPHOZAH could have on patients. We think that impact will be positive.

是的，麥克，我認為唯一需要補充的是，正如您所說，沒有監管承諾。這確實反映了我們希望更了解 XPHOZAH 這樣的藥物可能對患者產生的影響。我們認為這種影響將是正面的。

And I think the other piece of it is we also want to get a sense of patient satisfaction. You launch these drugs, you obviously have an objective to address unmet needs, and I think the ability to capture data on how patients are experiencing these drugs in their lived day-to-day sort of quality-of-life settings is really, really important.

我認為另一件事是我們也希望獲得患者的滿意度。你推出這些藥物，顯然你的目標是解決未滿足的需求，我認為能夠捕獲患者在日常生活中如何體驗這些藥物的數據，以提高生活質量，這真的非常非常重要。重要的。

Okay, great. Thanks, and maybe a follow-up. Yeah, Susan, in your comments, you mentioned out of the gate, working through prior offs, expecting that out of the gate, but again, back to the SPIRX data that -- it looks like about 20% or so of patients do not involve prior offs. Can you give a little bit of color, I guess, on maybe the dynamic going forward? Is it the goal to reduce the number of patients requiring prior offs, reduce the sort of lead time or the turnaround time for those or both, or any sort of comment on the dynamic and what your focus items are as you try to streamline the process for access?

好的，太好了。謝謝，也許還有後續行動。是的，蘇珊，在您的評論中，您提到了從一開始就完成了之前的工作，期待這一點，但再次回到 SPIRX 數據——看起來大約 20% 左右的患者沒有這樣做涉及之前的休息。我想，您能否對未來的動態進行一些說明？目標是減少需要提前休息的患者數量，減少這些或兩者的交付時間或週轉時間，還是在嘗試簡化流程時對動態和重點項目進行任何評論用於訪問？

Yeah, thanks, Chris. Yeah, we have been engaged with payers really months in advance of the approval, post-approval, now with the final label, and they're defining their coverage policies really exactly as we anticipated, very consistent with our labels, providing a path to access via a prior authorization, requiring the patient to have been treated on binders previously inadequately responding or intolerant binders.

是的，謝謝，克里斯。是的，我們在批准前幾個月就與付款人進行了接觸，批准後，現在有了最終標籤，他們正在定義他們的承保政策，與我們的預期完全一致，與我們的標籤非常一致，提供了一條途徑透過事先授權進行訪問，要求患者已經接受過先前反應不足或不耐受的黏合劑治療。

So, that is really our go-to-market strategy because we, at this time, do not intend to engage in contracting with the payers. XPHOZAH is the only non-binder available. It is the first-in-class faucet absorption inhibitor, the only option now for patients that have been treated on binders and have been found to be inadequate.

所以，這確實是我們的進入市場策略，因為我們目前不打算與付款人簽約。XPHOZAH 是唯一可用的非黏合劑。它是一流的龍頭吸收抑制劑，對於已經接受黏合劑治療但發現效果不充分的患者來說，這是目前的唯一選擇。

So, we really are not going to be contracting. There is no path forward for a formulary position that is going to be first before treatment with binders.

所以，我們真的不會簽訂合約。對於在使用黏合劑治療之前首先採用的處方位置，沒有前進的道路。

So, the prior off path is the direction that we're on. So, what's critical for our commercial success is the comprehensive patient services support in the office to enable that prior off process and getting the physician and the office comfortable with that process. And what we're finding exactly is with ISBRELA, once they run through the process a few times and they get more and more comfortable with it and realize that when they go through that administrative process, the patient ends up having access to XPHOZAH because of all of our patient assistance programs and ability to buy down their commercial copay. So, both from an access and affordability standpoint, our patient services really enable the physician to successfully navigate that PA process.

因此，先前的偏離路徑就是我們目前的方向。因此，我們商業成功的關鍵是辦公室內全面的患者服務支持，以實現優先處理流程，並使醫生和辦公室對該流程感到滿意。我們在 ISBRELA 中發現，一旦他們完成該流程幾次，他們就會越來越適應，並意識到當他們完成該管理流程時，患者最終可以使用 XPHOZAH，因為我們所有的患者援助計劃以及購買其商業共付額的能力。因此，從可近性和可負擔性的角度來看，我們的患者服務確實使醫生能夠成功地完成 PA 流程。

So, for us, the success and the access path is really continuing to support that nephrology interest and wanting to go through the process because they believe the patient's in need of XPHOZAH and supporting them through that process. What we're finding so far is that when they do so, we're getting those prior offs approved and patients are gaining access to XPHOZAH.

因此，對我們來說，成功和獲取途徑實際上是繼續支持腎臟病學的興趣並希望完成這個過程，因為他們相信患者需要 XPHOZAH 並支持他們完成這個過程。到目前為止我們發現，當他們這樣做時，我們就獲得了那些先前的治療批准，而患者可以使用 XPHOZAH。

Great. Thanks so much.

偉大的。非常感謝。

Laura Chico, Wedbush.

勞拉·奇科，韋德布希。

Hey, good afternoon. Thanks very much for taking my question. One on XPHOZAH and then one on IBSRELA. For XPHOZAH, could you just talk a little bit more about at what point you would move to secure [CDAPA] for XPHOZAH? And how should we think about the base case in terms of duration in which that would be active? I'm not sure if the [calcium] and medic experience would be a relevant proxy here.

嘿，下午好。非常感謝您提出我的問題。一張在 XPHOZAH 上，然後一張在 IBSRELA 上。對於 XPHOZAH，您能否多談談您將在什麼時候為 XPHOZAH 採取安全 [CDAPA] 措施？我們應該如何考慮基本情況的活躍持續時間？我不確定[鈣]和醫療經驗是否可以作為此處的相關代理人。

Yeah. So, Laura, I think we're still trying to determine that as well. Obviously, if we go into that, but we've got to go through getting the proper codes and doing that. So, I think as we get closer to that and get more clarity, we'll provide that commentary.

是的。所以，勞拉，我認為我們仍在努力確定這一點。顯然，如果我們進入這一點，但我們必須獲得正確的程式碼並執行此操作。因此，我認為，當我們越來越接近這一點並變得更加清晰時，我們將提供評論。

Okay. And then back to IBSRELA, I think Susan made the comment that you had kind of a changing view on who might be a good patient for this drug as you're getting more experience and exposure. Could you just expand on that a little bit further? And I guess specifically, I'm trying to understand a little bit more about how you're thinking about utilization earlier in the disease process. Are you seeing signs of earlier utilization with IBSRELA? Thank you.

好的。然後回到 IBSRELA，我認為 Susan 說過，隨著您獲得更多的經驗和接觸，您對誰可能是這種藥物的良好患者的看法發生了變化。能進一步擴展一下嗎？我想具體來說，我想更多地了解您如何考慮在疾病過程的早期利用。您是否看到了 IBSRELA 早期使用的跡象？謝謝。

Yeah. Actually, it's really an expanding view. So, what we're finding is that now that the HCPs who treat IBS-C have a novel mechanism option, they're increasingly identifying and aware of the patients that they had treated with GCC agonists, but are having persistent symptoms and really could benefit from a novel approach.

是的。事實上，這確實是一個擴展的觀點。因此，我們發現，現在治療 IBS-C 的 HCP 有了一種新的機制選擇，他們越來越多地識別和意識到他們曾使用 GCC 激動劑治療但症狀持續存在的患者，並且確實可能從新穎的方法中受益。

So, it's really the patients they treat every day, particularly these high-riding HCPs that we're focused on. Every patient that they see has likely been tried on a GCC agonist or is on a GCC agonist. And what we're finding, so those patients implicitly meet the prior authorization criteria. And what we're finding is that physicians are increasingly identifying them, engaging them in dialogue and saying, hey, there is a new therapy option available now that I really think you could benefit from. So, they're just expanding their view on patients now that actually could benefit from a novel approach since they've seen the good results for IBSRELA in the patients they initially tried it on.

因此，我們真正關注的是他們每天治療的患者，尤其是這些地位高的醫護人員。他們接診的每一位患者都可能已經嘗試過 GCC 激動劑或正在服用 GCC 激動劑。我們發現，這些患者隱含地符合事先授權標準。我們發現，醫生越來越多地識別他們，與他們進行對話，並說，嘿，現在有一種新的治療選擇，我真的認為你可以從中受益。因此，他們現在只是擴大了對實際上可以從一種新方法中受益的患者的看法，因為他們在最初嘗試的患者中看到了 IBSRELA 的良好效果。

Thank you.

謝謝。

Louise Chen, Cantor Fitzgerald.

路易絲·陳，坎托·菲茨杰拉德。

Hi. Congratulations on all the progress and thanks for taking my questions. So, I wanted to ask you, including the drawdown that you expect in March, what do you estimate your cash runway to be? And then also on tenapanor, I saw that you have a potential regulatory action coming in China. So, just curious how big that opportunity could potentially be for you? And then same question for Japan with the launch, how should we think about revenues in Japan in first-quarter '24 and beyond? Thank you.

你好。恭喜您取得的所有進展，並感謝您提出我的問題。所以，我想問您，包括您預計 3 月的回撤，您預計您的現金跑道是多少？然後在 Tenapanor 上，我看到中國可能會採取監管行動。那麼，只是好奇這個機會對您來說可能有多大？對日本來說，同樣的問題是，我們應該如何考慮 24 年第一季及以後在日本的營收？謝謝。

Sure. Let me address a couple of those things and then I'll pass it off to Justin. Recall that what we did with our relationship with KKC in Japan is we monetized those royalties, right? So, you shouldn't expect anything more coming from our partnership in Japan and it's up to KKC to speak to what kind of revenues they would expect out of their market.

當然。讓我解決一些問題，然後我會將其轉交給賈斯汀。回想一下，我們在日本與 KKC 的關係中所做的就是將這些版稅貨幣化，對嗎？因此，您不應該對我們在日本的合作夥伴關係產生任何更多期望，這取決於 KKC 來談論他們期望從市場中獲得什麼樣的收入。

With our relationship in China, certainly there's some regulatory actions that can happen there. We've not really spoken a whole lot about what the opportunity is and I think we'll hold off on that as well.

鑑於我們在中國的關係，那裡肯定會發生一些監管行動。我們還沒有真正談論過機會是什麼，我想我們也會推遲這一點。

In terms of the drawdown in March, we're probably not going to give you any specific numbers in terms of runway and what that provides, but if you can address that, Justin.

就三月的縮編而言，我們可能不會向您提供有關跑道及其提供的任何具體數字，但如果您能解決這個問題，賈斯汀。

Sure. Thank you, Louise, and thank you, Mike. We are overall starting to move towards what we'll call steady-state spending. So, this drawdown, of course, we're very mindful of how we bring in additional capital and we try to be thoughtful and measured in how we approach our spending and our planning. And so, on top of the $184.3 million we had at the end of the year, this really does put us in good shape and we are obviously always trying to balance need or fund our operations with other considerations.

當然。謝謝你，路易絲，謝謝你，麥克。我們整體上開始走向所謂的穩態支出。因此，當然，在這次縮減中，我們非常注意如何引入額外資本，並且我們在如何處理支出和規劃方面嘗試深思熟慮和衡量。因此，除了年底我們擁有的 1.843 億美元之外，這確實使我們處於良好的狀態，而且我們顯然一直在努力平衡需求或為我們的營運提供資金與其他考慮因素。

So, for us, we're taking it thoughtfully and measured, and we mentioned the increased activities we look to add to the commercial team this year and once we get into steady state, as I mentioned, we'll be able to give you more precise numbers. We're not really positioned to give you an exact date now, other than we're in really good shape in the near term.

因此，對我們來說，我們正在深思熟慮和衡量，我們提到了今年我們希望向商業團隊添加的更多活動，一旦我們進入穩定狀態，正如我提到的，我們將能夠為您提供更精確的數字。我們現在還不能給你一個確切的日期，除非我們在短期內處於非常好的狀態。

Okay. Thank you.

好的。謝謝。

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

Hi, Mike and team. Thank you. On the observational trial that you talked about, can you just talk a little bit more? Is there a fixed number of patients that can enroll or is it more open-ended? Will the patients that go into that trial be getting free drug? Are they still considered commercial patients?

嗨，麥克和團隊。謝謝。關於您談到的觀察性試驗，您能多談談嗎？可以參加的患者數量是固定的還是更開放？參加該試驗的患者會獲得免費藥物嗎？他們還被視為商業患者嗎？

And also just, you obviously had approval back in October. Just curious as to why the study's starting now versus, you know, right after when the drug was approved. Thanks.

而且，你顯然在 10 月就獲得了批准。只是好奇為什麼這項研究現在開始，而不是在藥物批准後立即開始。謝謝。

Sure. Laura?

當然。勞拉？

Yeah, sure. I mean, thanks, Yigal. I mean, the first question in terms of the number of patients, it is more open. I mean, obviously, it's a real-world study where, again, we're looking at patients who are being prescribed the drug in a real-world clinical setting.

好，當然。我的意思是，謝謝，伊格爾。我的意思是，第一個問題就患者數量而言，它更加開放。我的意思是，顯然，這是一項現實世界的研究，我們再次觀察在現實世界的臨床環境中服用該藥物的患者。

And so it's not free drug. It's basically patients who are, again, are either intolerant to phosphate binders or have not gotten to their treatment goal on binders alone. And so it's more of an open sort of enrollment piece. But again, the investigators that are looking to enroll patients will make that decision based on the normal shared decision-making between patients and physicians.

所以它不是免費的藥物。基本上，這些患者要么對磷酸鹽結合劑不耐受，要么僅依靠結合劑未達到治療目標。所以它更像是一種開放式的招生作品。但同樣，尋求招募患者的研究人員將根據患者和醫生之間正常的共同決策做出決定。

Yigal, to address your question about its commencement, is -- it takes time to get these things going and figuring out which investigators we'll work with. So nothing about that timeframe that -- relevant.

Yigal，要回答你關於其啟動的問題，是——讓這些事情進行下去並弄清楚我們將與哪些調查人員合作需要時間。因此，與該時間範圍無關。

Okay. And then I was doing some math on the guidance. So $140 million to $150 million works out to 9% to 12% quarter-on-quarter growth. So just curious about how you arrived at that. And then actually, if you carry that out into the future, and then you look at what happened with LINZESS. LINZESS, it launched December 2012, it got to $1 billion in 2021. It took nine years. If you take the low end of your guidance on quarter-on-quarter, you will get to $1 billion in, I guess, somewhere around 2029, 2030. So just curious what you think about that timetable.

好的。然後我根據指導做了一些數學計算。因此，1.4 億至 1.5 億美元相當於季增 9% 至 12%。所以只是好奇你是如何做到這一點的。事實上，如果你將這一點落實到未來，你會看到 LINZESS 發生了什麼事。LINZESS於2012年12月推出，2021年銷售額達10億美元。花了九年時間。如果你採用季度環比指引的下限，我猜你將在 2029 年、2030 年左右達到 10 億美元。所以只是好奇你對這個時間表的看法。

Well, I think your math is very good. But what we've said is that we see this as a billion-dollar opportunity. We haven't given a timeframe within which we will accomplish that. I think, I hope what you've learned about us, we're very measured in the way that we do this. And certainly if we see opportunity to give you more specificity around the timeframe of hitting those numbers, we will. But we're very confident with what we've guided for this year between$ 140 million, $150 million, certainly gets us on the kind of trajectory that you just described.

嗯，我認為你的數學很好。但我們所說的是，我們認為這是一個價值十億美元的機會。我們還沒有給出實現這一目標的時間表。我想，我希望您對我們的了解是，我們做事的方式非常謹慎。當然，如果我們看到機會為您提供有關達到這些數字的時間範圍的更多具體信息，我們會的。但我們對今年 1.4 億至 1.5 億美元的指導非常有信心，這肯定會讓我們走上您剛才描述的那種軌跡。

Okay, great. Thank you.

好的，太好了。謝謝。

Ryan Deschner, Raymond James.

瑞恩‧德施納，雷蒙德‧詹姆斯。

Hi there. My question is -- from our recent discussions with nephrologists over the last few weeks, we're hearing a heavy interest actually in the perceived compliance benefit associated with XPHOZAH for patient subpopulations, actually both with and without adequately controlled serum phosphorous. So my questions are, how big of a market segment is represented by patients who are failing phosphate binders largely due to poor compliance? And how are you thinking about potentially addressing the market segment represented by patients with controlled serum phosphorous who have strong desire to reduce pill burden in the future?

你好呀。我的問題是——從我們最近幾週與腎臟病專家的討論中，我們聽到人們對 XPHOZAH 對患者亞群的依從性益處非常感興趣，實際上無論是否有充分控制血清磷。所以我的問題是，主要因為依從性差而未能使用磷酸鹽結合劑的患者代表了多大的市場領域？您如何考慮潛在地解決以控制血清磷且強烈希望減少未來藥物負擔的患者為代表的細分市場？

Yeah, I mean, I'll let -- ask Susan to address some of this too, but that second population, that falls potentially within a definition of intolerance. If you think about how these patients have had to take these handfuls of pills every day, multiple meals, every meal and snack, that's a tolerance issue, not necessarily an efficacy issue. So we think that the indication that we were ultimately able to get from the FDA allows a physician to attest to either one of those two.

是的，我的意思是，我會讓——請蘇珊也解決其中的一些問題，但是第二個群體，這可能屬於不寬容的定義範圍。如果你想想這些患者如何每天服用這些藥片，多餐，每餐和零食，這是一個耐受性問題，不一定是療效問題。因此，我們認為我們最終能夠從 FDA 獲得的指示允許醫生證明這兩者中的任何一個。

Susan, anything to add?

蘇珊，有什麼要補充的嗎？

Yeah, I would just add that it's really important to note that consistently we see approximately 70% of patients, despite treatment with binders, are unable to achieve or maintain the global guideline target levels within a six-month period. So, and what we're finding now on the market in front of nephrologists is that they believe that the majority of their patients are unable to achieve or maintain target levels with binder therapy.

是的，我想補充一點，值得注意的是，我們一直看到大約 70% 的患者儘管接受了黏合劑治療，但仍無法在六個月內達到或維持全球指南目標水平。因此，我們現在在市場上擺在腎臟病專家面前的發現是，他們相信大多數患者無法透過黏合劑治療達到或維持目標水準。

So the population that aligned with our indication is really quite large. And I think it's -- and that's why we're seeing the enthusiasm on the part of the nephrology community to now finally have another option for those patients. And with the novel mechanism of XPHOZAH as a first-in-class phosphate absorption inhibitor, there's broad application to be used for those patients that are inadequately managed despite binder therapy.

因此，符合我們指示的人口數量確實相當大。我認為，這就是為什麼我們看到腎臟病學界的熱情，現在終於為這些患者提供了另一種選擇。憑藉 XPHOZAH 作為一流磷酸鹽吸收抑制劑的新穎機制，它可以廣泛應用於那些儘管進行了黏合劑治療但治療效果不佳的患者。

On top of that, the intolerance consideration, is another opportunity for use of XPHOZAH. So clearly, the compliance benefit is something that people speak to. I mean, one small pill twice a day, especially if it's being added to a therapy regimen, the patients are responding really favorably, like, wow, I could take this. Or if the physician decides to discontinue the binders, now they're on one pill twice a day.

最重要的是，不耐受性的考量是使用 XPHOZAH 的另一個機會。很明顯，合規性好處是人們談論的話題。我的意思是，每天兩次服用一顆小藥片，特別是如果將其添加到治療方案中，患者的反應非常好，就像，哇，我可以服用這個。或者，如果醫生決定停止使用黏合劑，現在他們每天服用兩次一粒藥。

Yeah, that's really resonating with physicians and with patients. And it's really part of the momentum driving the use of XPHOZAH. And ultimately, the compliance is so intermingled with why patients have been unable to reach target levels.

是的，這確實引起了醫生和患者的共鳴。這確實是推動 XPHOZAH 使用的動力的一部分。最終，依從性與患者無法達到目標水準的原因如此複雜。

So we're quite confident that there's a really strong opportunity within the labeled claim. And we're seeing that in the enthusiasm in the marketplace.

因此，我們非常有信心，標籤聲明中蘊藏著巨大的機會。我們從市場的熱情中看到了這一點。

Thanks so much. I appreciate it.

非常感謝。我很感激。

Joseph Thome, TD Cowen.

約瑟夫·托姆，TD·考恩。

Hi there. Good afternoon. Congrats on the progress. And thank you for taking my questions, everyone, on XPHOZAH. And I'll have a follow-up on ISBRELA if possible.

你好呀。午安.祝賀取得的進展。感謝大家在 XPHOZAH 上回答我的問題。如果可能的話，我將對 ISBRELA 進行後續追蹤。

But maybe first on XPHOZAH, are you able to provide any sort of information on the number of prescribers that have maybe written since launch? Or I guess if you can, going forward, what sort of metrics do you anticipate providing to kind of gauge how launch is progressing? And then I'll have a follow-up.

但也許首先在 XPHOZAH 上，您能否提供有關自推出以來可能已寫信的處方者數量的任何資訊？或者我想如果可以的話，您預計會提供什麼樣的指標來衡量發布的進度？然後我會跟進。

Hey, Joe. Thanks for the question. Obviously, understandable question given some of the data that you're accustomed to isn't available. But we're not going to be in a position to count physicians and do that. I think as we begin, as we did with IBSRELA, getting the comfort of a number of quarters underneath our belt, ultimately, the revenue guidance that we are going to give is going to be the most important thing for all of you to follow. And presumably, there will be some resolution as to how you can access script data, whether it's through outlets like you have in the past or acquiring those data as well.

嘿，喬。謝謝你的提問。顯然，鑑於您習慣的一些數據不可用，這是可以理解的問題。但我們無法統計醫生的數量並做到這一點。我認為，當我們開始時，就像我們對IBSRELA 所做的那樣，在我們的腰帶下獲得多個季度的舒適感，最終，我們將提供的收入指導將成為你們所有人遵循的最重要的事情。據推測，關於如何存取腳本數據，無論是透過像過去那樣的管道還是獲取這些數據，都會有一些解決方案。

And what's your question on IBSRELA?

您對 IBSRELA 有什麼問題？

And then on IBSRELA, I had a question on our ally study, the phase three in pediatric patients with IVSC. I guess, how important are data from this study? Kind of how is this progressing? And when you think about that expanded $1 billion market opportunity, does that include patients or a meaningful number of patients at all under age 18? Or would this be an expansion to that number if you're able to kind of get that on a label? Thanks.

然後在 IBSRELA 上，我對我們的盟友研究提出了一個問題，即 IVSC 兒科患者的第三階段研究。我想，這項研究的數據有多重要？這件事進展如何？當您考慮擴大後的 10 億美元市場機會時，這是否包括患者或大量 18 歲以下的患者？或者如果你能在標籤上得到這個數字，這會是這個數字的擴展嗎？謝謝。

Yeah, I think very basically, it'd be an expansion. But Laura, if you want to address the question about the trial.

是的，我認為基本上，這將是一個擴展。但是勞拉，如果你想解決有關審判的問題。

Yeah, in terms of the pediatric study, I mean, again, we've got an ongoing study in patients who are age 12 to 18. And that study is progressing nicely. And we have another study that is planned in pediatric patients age 6 to 11. So in terms of those studies, we see them progressing as planned.

是的，就兒科研究而言，我的意思是，我們正在對 12 至 18 歲的患者進行一項正在進行的研究。這項研究進展順利。我們計劃在 6 至 11 歲的兒科患者中進行另一項研究。因此，就這些研究而言，我們看到它們正在按計劃取得進展。

In terms of -- Mike, maybe you want to address the other part of the question in relationship to how that pertains to additional revenue.

就麥克而言，也許您想解決問題的另一部分，即與額外收入的關係。

Yeah, there's obviously a population there that we would -- that would benefit from a product like IBSRELA. I think quantifying that is going to, it's not something that we've done, but it's potentially something that we would think is an expansion.

是的，顯然那裡有一群人會從 IBSRELA 這樣的產品中受益。我認為量化這將是，這不是我們已經做過的事情，但它可能是我們認為是一種擴張的事情。

Great, thank you very much.

太好了，非常感謝。

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Hi, good afternoon. This is Thomas Yip asking a couple of questions for Ed. Thank you for the kind of questions.

嗨，下午好。我是 Thomas Yip，向 Ed 問了幾個問題。謝謝你提出這樣的問題。

So first on IBSRELA, can you provide some details on a plan that was previously announced to expand US sales scores, both in terms of scale and timing of the increase. Should we expect an incremental increase throughout the year or is it contingent on certain criteria for expansion?

首先，關於 IBSRELA，您能否提供一些有關先前宣布的擴大美國銷售分數計劃的詳細信息，無論是規模還是增加時間。我們是否應該預期全年會出現增量成長，還是取決於某些擴張標準？

Yeah, I think as you heard in our opening comments, we're taking the IBSRELA dedicated team from 64 to 124. And as Justin said in his commentary, steady-state spend on that we expect would be in evidenced by the third quarter of this year.

是的，我想正如您在我們的開場白中所聽到的，我們正在將 IBSRELA 專門團隊的人數從 64 人減少到 124 人。正如賈斯汀在評論中所說，我們預計今年第三季的穩態支出將得到證實。

Got it. Thank you. And then perhaps one more question on the XPHOZAH. When should we expect first time to provide revenue guidance? Should we expect something along the line of the [square hour]? In other words, about 12 months of sales before we see a guidance?

知道了。謝謝。也許還有一個關於 XPHOZAH 的問題。我們應該什麼時候首次提供收入指導？我們是否應該期待類似的事情發生？[平方小時]？換句話說，大約需要 12 個月的銷售量才能看到指導？

Yeah, I mean, I think that's prudent. When we see in some of the questions on this call, what the impact is of seasonality, the first quarter. All those things with IBSRELA, it was 4, 4.5, 5 quarters underneath our belt before we came out with any guidance.

是的，我的意思是，我認為這是謹慎的。當我們在這次電話會議的一些問題中看到，第一季的季節性影響是什麼。IBSRELA 的所有這些事情，在我們給出任何指導之前，我們已經進行了 4、4.5、5 個季度了。

All right, sounds good. Thank you again for your taking my questions.

好吧，聽起來不錯。再次感謝您回答我的問題。

Of course. Thank you.

當然。謝謝。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hey, guys. Thanks for taking the questions. Just wanted to stick on IBSRELA for a minute. What are you seeing, I guess, for IBSRELA with respect to its use in terms of duration on therapy and are our patients using it in a cyclical fashion, kind of come on and come off the drug?

大家好。感謝您提出問題。只是想堅持 IBSRELA 一分鐘。我想，您對 IBSRELA 在治療持續時間方面的使用有何看法？我們的患者是否以周期性方式使用它，有點開始和停藥？

Susan, you want to address that?

蘇珊，你想解決這個問題嗎？

Sure. Yes, Matt. So the feedback that we're getting from the physicians treating patients with IBSRELA is really highly favorable in terms of the patient response to therapy and satisfaction with therapy.

當然。是的，馬特。因此，我們從治療 IBSRELA 患者的醫生那裡得到的回饋在患者對治療的反應和對治療的滿意度方面確實非常有利。

Overall, we're finding that, as you have noted, IBS-C patients overall, when they're feeling better, tend to want to maybe stop taking the drug, knowing that if the symptoms come back, they would reinitiate therapy. So, at this point, we're finding that that overall behavior is probably consistent, regardless of the treatments that are prescribed.

總的來說，我們發現，正如您所指出的，IBS-C 患者總體來說，當他們感覺好些時，往往希望停止服藥，因為他們知道如果症狀復發，他們會重新開始治療。因此，在這一點上，我們發現無論採用何種治療方法，整體行為可能都是一致的。

But the good news from the marketplace is that physicians are keeping them on the drug and really believe that the drug is working.

但來自市場的好消息是，醫生讓他們繼續服用該藥物，並且確實相信該藥物有效。

Okay, that's helpful. And then, and then with respect to XPHOZAH, what are you seeing in terms of the current mixture of patients on XPHOZAH in terms of using it in a combo setting versus a monotherapy? And I guess, how would you -- how do you think that evolves over time?

好的，這很有幫助。然後，關於 XPHOZAH，您對目前使用 XPHOZAH 的患者組合在組合療法與單一療法中使用它的情況有何看法？我想，你認為隨著時間的推移，情況會如何演變？

I'm not sure we have exact visibility into other prescriptions, right? So, this is a -- we have a closed system with our with our adult assist program that helps the prior authorization process. Susan, do we have perspective on that?

我不確定我們對其他處方有確切的了解，對吧？所以，這是一個——我們有一個封閉的系統，我們的成人協助計劃可以幫助事先授權過程。蘇珊，我們對此有看法嗎？

Yeah, actually, it's a great question, Matt. So, I think that there isn't a quantitative answer, but what we could say is based on our experience now in the offices that we're seeing physicians adding XPHOZAH to the current regimen and seeing a nice response in phosphorus reduction, we're seeing patients reducing the binder dose and adding XPHOZAH and also having a favorable experience. And we're seeing physicians just eliminate the binders and initiate use of XPHOZAH and seeing a response or if they, and then potentially adding back the binder if they need it.

是的，實際上，這是一個很好的問題，馬特。所以，我認為沒有定量的答案，但我們可以說的是，根據我們現在在辦公室的經驗，我們看到醫生將 XPHOZAH 添加到當前的治療方案中，並看到磷減少的良好反應，我們'我們看到患者減少了黏合劑劑量並添加XPHOZAH，並且也獲得了良好的體驗。我們看到醫生只是消除黏合劑並開始使用 XPHOZAH 並看到反應或如果他們需要，然後可能會在需要時重新添加黏合劑。

So, so I think early in the launch, what we're finding is that because of the novel phosphate blocking mechanism and one small pill twice a day, it really gives the physician a lot of flexibility in terms of how to use the product. And then overall, they're telling us that the patients are responding favorably and satisfied and they're seeing reductions in phosphorus levels.

因此，我認為在推出之初，我們發現，由於新穎的磷酸鹽阻斷機制和每天兩次一顆小藥丸，它確實為醫生在如何使用產品方面提供了很大的靈活性。總的來說，他們告訴我們，患者的反應良好且滿意，並且他們看到磷水平下降。

So, so it's all very encouraging. Over time, we'll do our own -- as we contract this and market research, it would have to be custom work. It's not really something available through the script data. We'll have a better understanding on how that cuts. But overall, it really just leads to a broad-based use and I, and seeing XPHOZAH as applicable to a broad range of patients and that they can customize.

所以，這一切都非常令人鼓舞。隨著時間的推移，我們將自己做——當我們承包這個和市場研究時，它必須是定制工作。它並不是真正可以透過腳本資料獲得的東西。我們將對如何削減有更好的理解。但總的來說，它確實帶來了廣泛的使用，我認為 XPHOZAH 適用於廣泛的患者，而且他們可以客製化。

And Matt, I think that's why we refer -- why we're referring to this as an XPHOZAH-based regimen is it allows the flexibility for clinicians to do exactly what Susan just described.

馬特，我認為這就是我們提到的原因 - 為什麼我們將其稱為基於 XPHOZAH 的治療方案，因為它允許臨床醫生靈活地執行蘇珊剛才描述的操作。

Great. Well, congrats on the progress and thanks for taking the questions.

偉大的。好吧，祝賀您取得的進展，並感謝您提出問題。

Thanks, Matt.

謝謝，馬特。

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

我們的問答環節到此結束。我想將會議轉回 Ardelyx 總裁兼執行長 Mike Raab 致閉幕詞。

Thank you everyone for joining us this evening and especially to those many shareholders who've been on this wild ride with us, whether for the past few years, the past few months, or even the past few weeks. I hope that what you've seen and heard from us today is that we are thoughtful and measured in how we build our business, that we focus on executing on our priorities, and that we have the right team in place.

感謝大家今晚加入我們，特別是感謝那些與我們一起經歷這瘋狂旅程的股東，無論是過去幾年、過去幾個月，甚至是過去幾週。我希望您今天從我們這裡看到和聽到的是，我們在如何建立業務方面是深思熟慮和謹慎的，我們專注於執行我們的優先事項，並且我們擁有合適的團隊。

And to that team, team Ardelyx, I would like to extend a special and heartfelt thanks to all of you for what you do every day to further our efforts, to deliver on our mission, and most importantly, to support patients.

對於 Ardelyx 團隊，我要向你們所有人表示特別和衷心的感謝，感謝你們每天所做的一切，以進一步推動我們的努力，實現我們的使命，最重要的是，為患者提供支持。

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

這樣，我們就可以結束通話了。謝謝你，丹妮爾。