Ardelyx Inc (ARDX) 2023 Q2 法說會逐字稿

Hello and welcome to the Ardelyx Second Quarter 2023 Conference Call. (Operator Instructions). Please note, this event is being recorded.

您好，歡迎參加 Ardelyx 2023 年第二季度電話會議。 （操作員說明）。請注意，此事件正在被記錄。

I'd now like to turn the conference over to Caitlin Lowie. Please go ahead, ma'am.

我現在想把會議交給凱特琳·洛伊。請繼續，女士。

Thank you. Good morning, and welcome to our second quarter 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. 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 our 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.

謝謝。早上好，歡迎參加我們的第二季度財務業績電話會議。在本次電話會議中，我們將參考今天早些時候發布的新聞稿，該新聞稿可在公司網站 ardelyx.com 的投資者部分獲取。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存在重大差異。我們鼓勵您查看我們今天提交的最新季度報告 10-Q 表格中的風險因素，該報告可以在我們的網站 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，但我們特別聲明不承擔任何這樣做的義務，即使我們的觀點發生變化。

Our President and CEO, Mike Raab will begin today's call with opening remarks and an overview of the company's progress during the second quarter of 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the launch of IBSRELA. Justin Renz, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the second quarter ended June 30, 2023, before we open the call to questions.

我們的總裁兼首席執行官 Mike Raab 將在今天的電話會議上致開幕詞並概述公司 2023 年第二季度的進展。接下來，首席商務官 Susan Rodriguez 將提供 IBSRELA 推出的最新信息。在我們開始提問之前，首席財務和運營官 Justin Renz 將回顧公司截至 2023 年 6 月 30 日的第二季度的財務業績，以總結今天準備好的發言。

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

接下來，讓我把電話轉給邁克。

Good morning, everyone, and thank you for joining us on the call. I'm really pleased to be here today and along with Susan and Justin to share with you the progress we've made over the past quarter. At the midway point of 2023, we are excited about the critical milestones we've achieved, the continued execution of our priorities and the important 2 quarters ahead of us. IBSRELA is making significant inroads in the IBS-C market as health care practitioners and patients recognize the benefits of its novel mechanism profile.

大家早上好，感謝您加入我們的電話會議。我很高興今天能與蘇珊和賈斯汀一起與大家分享我們在過去一個季度取得的進展。 2023 年已過半，我們對所實現的關鍵里程碑、對優先事項的持續執行以及接下來重要的兩個季度感到興奮。隨著醫療保健從業者和患者認識到 IBSRELA 新穎機制的優勢，IBSRELA 正在 IBS-C 市場取得重大進展。

Our growth rate accelerated with net sales revenue in the second quarter of $18.3 million, reflecting a 61% increase in net sales revenue over Q1. This performance is the result of the incredible efforts of the team that is fully engaged in the field, calling on HCPs and articulating the unique value proposition that IBSRELA offers patients who are in need of a new treatment option.

我們的增長率加快，第二季度淨銷售收入達到 1,830 萬美元，淨銷售收入比第一季度增長 61%。這一業績是團隊全力投入該領域的令人難以置信的努力的結果，他們呼籲 HCP 並闡明 IBSRELA 為需要新治療選擇的患者提供的獨特價值主張。

At this stage of our commercialization of IBSRELA, we're excited to provide revenue guidance for the very first time. We currently expect to draw a net sales revenue for 2023 to be in the range of $72 million to $77 million. Physician adoption, patient need and positive treatment experiences as well as a favorable access are the fundamentals driving our IBSRELA growth. And we believe the strength of these forces continues to predict expanded use of IBSRELA.

在 IBSRELA 商業化的現階段，我們很高興能夠首次提供收入指導。我們目前預計 2023 年的淨銷售收入將在 7200 萬美元至 7700 萬美元之間。醫生的採用、患者的需求、積極的治療體驗以及有利的獲取途徑是推動我們 IBSRELA 發展的基礎。我們相信，這些力量的力量將繼續預測 IBSRELA 的使用將會擴大。

As we've said, physicians are finding relatively an important treatment option for their patients with IBS-C. Patients are experiencing positive results and refilling their prescriptions. Access to IBSRELA is favorable enabled by our best-in-class patient services program, ArdelyxAssist. We are confident in the future performance of the IBSRELA, and we hope that this guidance will offer better insight into our expectations for this product in the market.

正如我們所說，醫生正在為 IBS-C 患者尋找相對重要的治療選擇。患者正在體驗積極的結果並重新配藥。我們一流的患者服務計劃 ArdelyxAssist 為獲得 IBSRELA 提供了便利。我們對 IBSRELA 的未來表現充滿信心，我們希望本指南能夠更好地了解我們對該產品在市場上的期望。

As it relates to XPHOZAH, meaningful progress has been made since we spoke in May. First, as we announced mid-May, the FDA had set the review -- goal review date for XPHOZAH of October 17, and we expect to launch XPHOZAH in the fourth quarter of this year as quickly as possible following approval. Market awareness, interest and intent to adopt XPHOZAH is high.

就 XPHOZAH 而言，自我們 5 月份講話以來已經取得了有意義的進展。首先，正如我們5月中旬宣布的那樣，FDA已將XPHOZAH的審評目標定為10月17日，我們預計在獲得批准後儘快在今年第四季度推出XPHOZAH。市場對採用 XPHOZAH 的認知度、興趣和意願很高。

We will have comprehensive sales, medical affairs, patient services, and payer access support in place at launch. And as we get closer to launch, we will share more details on our expectations for XPHOZAH and our launch plan to drive uptake and long-term success.

我們將在推出時提供全面的銷售、醫療事務、患者服務和付款人訪問支持。隨著發佈時間的臨近，我們將分享更多關於我們對 XPHOZAH 的期望的細節以及我們的發布計劃，以推動採用和長期成功。

Second, as you may have seen, a bipartisan bill was introduced last week in the House of Representatives by Buddy Carter, Carol Miller, Annie Kuster and Terri Sewell that would delay the implementation of the oral-only policy under the Medicare ESRD prospective payment system or PPS through January 1, 2033. The introduction of this bill is an important first step and extending the exclusion of the oral-only ESRD drugs from the PPS. Currently, oral-only phosphorus-lowering treatments, which exposed would be considered upon approval, are scheduled to enter the PPS beginning in January of 2025. Eliminating separate payment under Medicare Part D for the approximately 60% to 65% of CKD patients on dialysis who are covered by Medicare.

其次，正如您可能已經看到的，巴迪·卡特(Buddy Carter)、卡羅爾·米勒(Carol Miller)、安妮·庫斯特(Annie Kuster) 和特麗·休厄爾(Terri Sewell)上週在眾議院提出了一項兩黨法案，該法案將推遲Medicare ESRD 預期支付系統下僅口頭政策的實施或PPS 的有效期至2033 年1 月1 日。該法案的推出是重要的第一步，並將僅口服ESRD 藥物排除在PPS 之外。目前，純口服降磷治療計劃於 2025 年 1 月開始納入 PPS，經批准後將予以考慮。取消 Medicare D 部分中約 60% 至 65% 的透析 CKD 患者的單獨付款受醫療保險覆蓋的人。

We believe this important legislation is in the best interest of patients and we joined the entire kidney community, advocates, patients, nephrologists and dialysis providers that support the efforts to advance it. Congress taking action to extend this exclusion as it has done 3 previous occasions will ensure that CKD patients on dialysis continue to have access to personalized care and innovation.

我們相信這項重要的立法符合患者的最佳利益，我們與整個腎臟界、倡導者、患者、腎病專家和透析提供者一起支持推動這項立法的努力。國會將像之前 3 次那樣採取行動擴大這一排除範圍，這將確保接受透析的 CKD 患者繼續獲得個性化護理和創新。

Pending approval of XPHOZAH by the end of this year, within 2 years, Ardelyx will have launched 2 highly differentiated commercial products in markets for patients with significant unmet medical needs, twice delivering on the vision of Ardelyx. I see few biotechnology companies have ever accomplished. Susan will now talk through the market dynamics and key performance metrics that are driving our success and accelerated sales growth for IBSRELA. Susan?

待今年年底 XPHOZAH 獲得批准，兩年內，Ardelyx 將在市場上推出 2 款高度差異化的商業產品，面向醫療需求未得到滿足的患者，兩次實現 Ardelyx 的願景。我發現很少有生物技術公司能夠取得這樣的成就。 Susan 現在將討論推動我們成功並加速 IBSRELA 銷售增長的市場動態和關鍵績效指標。蘇珊？

Thank you, Mike. 15 months into the launch of IBSRELA, we are establishing a strong early market position disrupting the IBS-C market by addressing the need for novel mechanism treatment options. With a strong sales force of more than 60 reps having daily interaction with the top riding IBS-C HCP, we continue to focus on driving both breadth and depth of IBSRELA writing across HCPs for their patients who can benefit from a novel treatment approach.

謝謝你，邁克。 IBSRELA 推出 15 個月後，我們正在建立強大的早期市場地位，通過滿足對新機制治療方案的需求來擾亂 IBS-C 市場。我們擁有一支由60 多名銷售代表組成的強大銷售隊伍，每天與頂尖的IBS-C HCP 進行互動，我們將繼續專注於推動IBSRELA 跨HCP 撰寫的廣度和深度，讓患者能夠從新穎的治療方法中受益。

Our omnichannel digital tactics further amplify our commercial presence, enabling continuous engagement with existing writers as well as expanding awareness to cultivate new writers. With new writers continuously being added and existing writers increasing their prescribing, IBSRELA is redefining the treatment landscape.

我們的全渠道數字策略進一步擴大了我們的商業影響力，實現了與現有作家的持續接觸，並擴大了培養新作家的意識。隨著新作者的不斷增加和現有作者處方的增加，IBSRELA 正在重新定義治療格局。

Our Q2 sales performance and revenue growth over Q1 reflects the growing uptake of IBSRELA and the opportunity we believe this drug offers for a meaningful subset of patients that up until the launch of IBSRELA had limited treatment options. This market is highly promotion sensitive. Our market presence is strong and the value proposition of IBSRELA is resonating with HCPs and patients.

我們第二季度的銷售業績和較第一季度的收入增長反映了 IBSRELA 的使用量不斷增長，以及我們相信該藥物為一小部分患者提供的機會，在 IBSRELA 上市之前，這些患者的治療選擇有限。這個市場對促銷高度敏感。我們的市場影響力很強，IBSRELA 的價值主張引起了 HCP 和患者的共鳴。

The May 2023 launch dynamics tracking report published in Q2 by Spherix, an independent market research firm provides a view of the market response to IBSRELA based on a monthly launch tracking survey across a sample of GI. The May 2023 findings reported based on the 76 GI survey that 91% rated IBSRELA as an advance over existing therapy. Additionally, of the subset of respondents who reported using IBSRELA, 98% reported satisfaction with treatment.

獨立市場研究公司 Spherix 在第二季度發布的 2023 年 5 月發射動態跟踪報告根據對 GI 樣本的每月發射跟踪調查，提供了對 IBSRELA 的市場反應的看法。 2023 年 5 月的研究結果基於 76 名胃腸道調查報告，其中 91% 的人認為 IBSRELA 比現有療法有所進步。此外，在報告使用 IBSRELA 的受訪者中，98% 的人對治療表示滿意。

The May 2023 Spherix survey results also provide a view of the strength of our targeted commercial presence in high IBS-C writing HCP offices with 74% of survey TIs reporting seeing in IBSRELA reps, of which the majority reported being a rep within the last 3 months. These results align with the persistent growth that we are seeing in both new and refill prescriptions and the feedback we received daily from HCP.

2023 年 5 月的 Spherix 調查結果還顯示了我們在高 IBS-C 寫作 HCP 辦公室中的目標商業存在的強度，74% 的調查 TI 報告看到了 IBSRELA 代表，其中大多數報告是過去 3 年內的代表幾個月。這些結果與我們在新處方和補充處方中看到的持續增長以及我們每天從 HCP 收到的反饋一致。

HCPs are interested in IBSRELA are engaging actively with our sales team, responding to our omnichannel communications, adopting IBSRELA and continuously expanding their use across their practice based on their favorable treatment experience. Momentum is strong and the potential is high.

對 IBSRELA 感興趣的 HCP 正在積極與我們的銷售團隊合作，響應我們的全渠道溝通，採用 IBSRELA 並根據其良好的治療經驗不斷擴大其在整個實踐中的使用。勢頭強勁，潛力巨大。

We believe the opportunity for this drug to deliver sales for Ardelyx of $500 million or more at peak is very real. Our commercial presence is strong and making an impact. The novel mechanism and clinical profile resonate with physicians. Patients are gaining access to the drug and seeing positive results. The need is clear, the opportunity is clear. The product is performing and the team is executing at the highest level.

我們相信，這種藥物為 Ardelyx 帶來 5 億美元或更多峰值銷售額的機會是非常真實的。我們的商業影響力強大並產生影響。這種新穎的機制和臨床特徵引起了醫生的共鳴。患者正在獲得該藥物並看到積極的結果。需求很明確，機會也很明確。產品正在發揮作用，團隊正在以最高水平執行。

Commercial capabilities at Ardelyx are strong, prudent and mobilizing to be prepared to launch XPHOZAH if approved in the fourth quarter of this year. Marketing, distribution, payer access and patient services commercial ramp has been ongoing with the build-out of the nephrology sales team now underway. Upon its approval, XPHOZAH like IBSRELA will be a novel mechanism therapy entering into an established therapeutic area with limited treatment options that is highly accessible via targeted focus on a concentrated number of HCP.

Ardelyx 的商業能力強大、謹慎且積極，如果在今年第四季度獲得批准，就可以準備推出 XPHOZAH。營銷、分銷、付款人訪問和患者服務商業增長一直在進行，腎髒病銷售團隊的建設正在進行中。一旦獲得批准，XPHOZAH 與 IBSRELA 一樣，將成為一種新穎的機制療法，進入治療選擇有限的既定治療領域，通過有針對性地關注集中數量的 HCP，可以輕鬆實現這一領域。

Our strategy centers on treating nephrologists with a product positioning directed at patients with unmet medical needs and a path to access to bring this first-in-class phosphate absorption inhibitor XPHOZAH to patients. I look forward to continuing to report on our IBSRELA performance as well as sharing more detail on the XPHOZAH launch in the near future.

我們的戰略重點是通過針對醫療需求未得到滿足的患者的產品定位來治療腎病專家，並提供將這種一流的磷酸鹽吸收抑製劑 XPHOZAH 帶給患者的途徑。我期待在不久的將來繼續報告我們的 IBSRELA 表現，並分享有關 XPHOZAH 發布的更多細節。

With that, I will hand it to Justin.

這樣，我會把它交給賈斯汀。

Thank you, Susan. Our second quarter of 2023 reflects positive momentum on a number of financial metrics, accelerated sales growth, improvement to our gross to net margin as compared to last quarter, careful monitoring of cash expenditures and strengthening of our balance sheet and the methodical manner we have [faced] over the past several quarters. I will walk through those metrics now and then discuss the guidance we provided today for IBSRELA net product sales in 2023.

謝謝你，蘇珊。我們2023 年第二季度的業績反映了多項財務指標的積極勢頭、加速的銷售增長、毛利率與上季度相比的改善、對現金支出的仔細監控、資產負債表的加強以及我們的有條不紊的方式。過去幾個季度面臨]。我現在將介紹這些指標，然後討論我們今天為 2023 年 IBSRELA 產品淨銷售額提供的指導。

In the second quarter of 2023, we had total revenue of $22.3 million compared to $2.5 million in the second quarter of 2022, reflecting increases to both our net product sales of IBSRELA and our product supply and licensing-related revenues. As previously mentioned, we had net product sales of IBSRELA in Q2 2023 of $18.3 million, which is significant 61% quarter-over-quarter growth of the $11.4 million we reported in the first quarter.

2023 年第二季度，我們的總收入為 2230 萬美元，而 2022 年第二季度為 250 萬美元，反映出我們 IBSRELA 產品淨銷售額以及產品供應和許可相關收入的增長。如前所述，我們在 2023 年第二季度的 IBSRELA 產品淨銷售額為 1830 萬美元，與我們第一季度報告的 1140 萬美元相比，環比增長了 61%。

As a reminder, in the second quarter of 2022, our first full quarter scale following launch, we reported net product sales of $1.6 million. We also reported $4 million in product supply and licensing-related revenue in the second quarter of this year compared to $1 million in the second quarter of 2022.

提醒一下，在 2022 年第二季度，即我們推出後的第一個完整季度規模，我們報告的產品淨銷售額為 160 萬美元。我們還報告稱，今年第二季度的產品供應和許可相關收入為 400 萬美元，而 2022 年第二季度為 100 萬美元。

Research and development expenses were $8.3 million for the quarter ended June 30, 2023, which is a decrease of $1.4 million from $9.7 million for the same quarter last year. Expenses in the prior year reflects higher tenapanor manufacturing expenses as well as costs associated with our appeal of the FDA July 2021 complete response letter on the NDA for disposal.

截至 2023 年 6 月 30 日的季度，研發費用為 830 萬美元，比去年同期的 970 萬美元減少 140 萬美元。上一年的費用反映了較高的 Tenapanor 製造費用以及與我們呼籲 FDA 2021 年 7 月對 NDA 進行處置的完整答复函相關的費用。

We saw our gross to net margin improved in the second quarter when compared to the first quarter. As we expected, as health care plans reset a new calendar year, gross to net was somewhat higher in the first quarter than it had been in the third and fourth quarter of 2022. We were pleased to see that our gross to net improved in the second quarter of 2023 to be approximately 28%. We anticipate the gross to net margin to continue to be in the high 20s for the remainder of 2023.

與第一季度相比，我們看到第二季度的毛利率有所改善。正如我們預期的那樣，隨著醫療保健計劃重置新的日曆年，第一季度的毛淨值比2022 年第三季度和第四季度有所提高。我們很高興看到我們的毛淨值在2022 年有所改善。 2023 年第二季度約為 28%。我們預計 2023 年剩餘時間內毛利率與淨利潤率將繼續保持在 20 多歲左右。

Selling, general and administrative expenses were $27.2 million for the second quarter of 2023, an increase of $8.3 million when compared to the $18.9 million in the same period of 2022. The increase was primarily due to the increased costs associated with the continued commercialization and growth of IBSRELA.

2023 年第二季度的銷售、一般和管理費用為 2720 萬美元，比 2022 年同期的 1890 萬美元增加了 830 萬美元。這一增長主要是由於與持續商業化和增長相關的成本增加IBSRELA。

For the quarter ended June 30, 2022, we had net loss of approximately $17.1 million or $0.08 per fully diluted share compared to a net loss of $26.9 million or $0.19 per share in the second quarter of 2022.

截至2022 年6 月30 日的季度，我們的淨虧損約為1710 萬美元，即完全稀釋後每股虧損0.08 美元，而2022 年第二季度的淨虧損為2690 萬美元，即每股虧損0.19 美元。

The net loss for the quarter ended June 30, 2023, including $4.2 million in combined noncash expenses from share-based compensation and noncash interest expenses.

截至 2023 年 6 月 30 日的季度淨虧損，包括來自股權激勵和非現金利息支出的 420 萬美元合併非現金支出。

As of June 30, 2023, we had total cash, cash equivalents and short-term investments of $127.6 million as compared to $123.9 million at December 31, 2022. This reflects $11.6 million we weighed during the quarter through sales of approximately 3 million shares of common stock under our ATM program. We will continue to be patient and explore further opportunities to raise additional capital for the company.

截至2023 年6 月30 日，我們的現金、現金等價物和短期投資總額為1.276 億美元，而2022 年12 月31 日為1.239 億美元。這反映了我們在本季度通過出售約300 萬股股票獲得的1160 萬美元。我們的 ATM 計劃下的普通股。我們將繼續保持耐心，探索更多機會為公司籌集額外資金。

I'm now going to walk through some of the details of our financial expectations for the next 12 months. First, as you saw in our press release this morning and as you heard from Mike, for the first time, we shared full year net sales revenue guidance for IBSRELA. 15 months following the launch, we continue to see sales trends moving in a steady positive direction. Patients are refilling their prescriptions Previously writing HCPs are finding new patients, and we have new HCPs running every day. Our strategy to grow depth and breadth of providers is working. We are also gaining visibility to patterns and dynamics of its launch each day, enabling us to make more firm projections.

我現在將詳細介紹我們未來 12 個月的財務預期。首先，正如您在今天早上的新聞稿中看到的，以及您從邁克那裡聽到的，我們第一次分享了 IBSRELA 的全年淨銷售收入指引。推出 15 個月後，我們繼續看到銷售趨勢朝著穩定的積極方向發展。患者正在重新配藥 之前撰寫的 HCP 正在尋找新患者，我們每天都有新的 HCP 運行。我們擴大供應商深度和廣度的戰略正在發揮作用。我們還可以了解其每天發布的模式和動態，使我們能夠做出更堅定的預測。

We currently expect net IBSRELA sales revenue for full year 2023 to be between $72 million and $77 million. At the end of the second quarter, we recorded year-to-date 2023 net sales revenue of $29.7 million. This full year guidance range represents a thoughtful consideration of continued growth consistent with the volume of new prescriptions we've seen, a favorable growth trajectory for refill prescriptions and strong demand and interest for this novel treatment. We have confidence in IBSRELA's potential and we continue to believe IBSRELA can generate $500 million or more in net sales revenue at peak.

我們目前預計 2023 年全年 IBSRELA 淨銷售收入將在 7200 萬美元至 7700 萬美元之間。截至第二季度末，我們 2023 年迄今的淨銷售收入為 2970 萬美元。這一全年指導範圍代表了對與我們所看到的新處方量一致的持續增長的深思熟慮、續配處方的有利增長軌跡以及對這種新型治療的強烈需求和興趣。我們對 IBSRELA 的潛力充滿信心，並且仍然相信 IBSRELA 在高峰期可以產生 5 億美元或更多的淨銷售收入。

In addition, I wanted to address the question we received related to Symphony script tracking data. As we start to understand the differences between our reported revenue and the Symphony script data, we have identified that the numbers reported by Symphony include prescriptions from the pharmacy that will build prescriptions for our patient assistance program.

此外，我想解決我們收到的有關 Symphony 腳本跟踪數據的問題。當我們開始了解報告的收入與 Symphony 腳本數據之間的差異時，我們發現 Symphony 報告的數字包括來自藥房的處方，這些藥房將為我們的患者援助計劃制定處方。

Ardelyx does not receive revenue from patient assistance program prescriptions. And for this reason, the Symphony data is not directly tied (inaudible). In addition, as Susan shared, we will begin investing this quarter to prepare for the launch of XPHOZAH in the fourth quarter pending approval. When we launched XPHOZAH, if approved and as we ramp up, we expect incremental expenditures to be approximately $20 million per quarter. We hope to quickly drive uptake and establish a position for XPHOZAH in hyperphosphatemia treatment landscape.

Ardelyx 不從患者援助計劃處方中獲得收入。因此，Symphony 數據不直接關聯（聽不清）。此外，正如 Susan 所分享的，我們將於本季度開始投資，為第四季度推出 XPHOZAH 做準備，等待批准。當我們推出 XPHOZAH 時，如果獲得批准並且隨著我們的增加，我們預計每季度增量支出約為 2000 萬美元。我們希望快速推動 XPHOZAH 在高磷血症治療領域的應用並確立其地位。

Finally, as we have discussed in previous quarters, we will continue to strengthen our cash position by looking at all options available to them, including nonequity solutions. As a reminder, we expect to recognize a $2 million milestone payment in the third quarter from our partner in China, Fosun Pharma following the acceptance of the NDA for tenapanor for hyperphosphatemia, which we announced earlier in July.

最後，正如我們在前幾個季度所討論的那樣，我們將通過考慮他們可用的所有選擇（包括非股權解決方案）來繼續加強我們的現金狀況。提醒一下，繼我們於 7 月初宣布接受 Tenapanor 治療高磷血症的 NDA 後，我們預計將在第三季度從我們的中國合作夥伴復星醫藥那裡獲得 200 萬美元的里程碑付款。

In addition, assuming the approval of tenapanor for hyperphosphatemia in Japan, we will earn another milestone payment later this year from our Japanese partner, Kyowa Kirin Co. Led by the continued growth of IBSRELA, we are in excellent financial position as we prepare for the XPHOZAH launch. We are confident in our ability to fund our operations, and we will continue to make thoughtful decisions to maximize shareholder value.

此外，假設Tenapanor 在日本獲得批准用於治療高磷血症，我們將於今年晚些時候從我們的日本合作夥伴Kyowa Kirin Co. 那裡獲得另一筆里程碑式的付款。在IBSRELA 持續增長的帶動下，我們處於良好的財務狀況，為我們的XPHOZAH 發射。我們對自己為運營提供資金的能力充滿信心，並將繼續做出深思熟慮的決策，以最大限度地提高股東價值。

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

這樣，我就把它交給邁克了。

Thanks, Justin. Q2 was another quarter where our Ardelyx achieved important milestones, delivered on our priorities and strengthened our business. We are excited with IBSRELA's performance and are beginning to see upside for this product. The team behind IBSRELA is focused, dedicated and driven to help the patients that we serve. They have set a standard for the type of success and innovative thinking that can be expected from the Ardelyx commercial organization. Demand for XPHOZAH is high, and we believe we have the potential for a strong launch after approval. We continue to support our partners' regulatory submissions while engaging in discussions for further international expansion and looking at all the options available to us from a financing perspective. Before closing, I would like to take a moment, as I always do, to thank the incredible team Ardelyx, your talent, your passion and commitment are the driving force behind the performance that we've shared today.

謝謝，賈斯汀。第二季度是我們的 Ardelyx 實現重要里程碑、實現我們的優先事項並加強我們的業務的另一個季度。我們對 IBSRELA 的性能感到興奮，並開始看到該產品的優勢。 IBSRELA 背後的團隊專注、專注並致力於幫助我們所服務的患者。他們為 Ardelyx 商業組織的成功類型和創新思維設定了標準。 XPHOZAH 的需求很高，我們相信在獲得批准後我們有潛力大力推出。我們繼續支持合作夥伴提交監管申請，同時參與進一步國際擴張的討論，並從融資角度考慮我們可用的所有選擇。在結束之前，我想像往常一樣，花一點時間感謝令人難以置信的 Ardelyx 團隊，你們的才華、你們的熱情和奉獻精神是我們今天分享的業績背後的驅動力。

I will now open the call to questions. Operator?

我現在開始提問。操作員？

(Operator Instructions). And the first question comes from Yigal Nochomovitz with Citigroup.

（操作員說明）。第一個問題來自花旗集團的 Yigal Nochomovitz。

Could you just spend a little bit more time talking about the assumptions behind the newly introduced guidance range. Obviously, it implies a quarterly growth over -- quarter-over-quarter growth potentially lower than what you saw 2Q over 1Q for the back half of the year. So if you could just delve into that a little bit more. And then on the legislation with the bundling, can you talk about the likelihood that, that legislation will come to fruition? And keep the orals out of the bundle to 2033.

您能多花一點時間討論一下新引入的指導範圍背後的假設嗎？顯然，這意味著今年下半年的季度增長率可能低於第二季度和第一季度的增長率。所以如果你能再深入研究一下的話。然後關於捆綁銷售的立法，您能談談該立法取得成果的可能性嗎？並在 2033 年之前將口頭內容排除在捆綁之外。

Sure. Let me start with the last part first is I feel like starting to sing schoolhouse rock as to how the bill becomes a law. And so I can't give you any specific percentages on the probabilities. This is such an important first step. What we're focused on is making sure that the team is ready to launch in the fourth quarter, pending approval, and we'll take it step by step. I think this is such a strong message of what Congress has previously done 3 other times, that it gives me some hope and optimism, but I can't give you specific numbers.

當然。首先讓我從最後一部分開始，我想開始唱校舍搖滾來講述該法案如何成為法律。所以我不能給你任何具體的概率百分比。這是非常重要的第一步。我們的重點是確保團隊準備好在第四季度啟動，等待批准，我們將一步一步地進行。我認為這是國會之前三次所做的事情的強烈信息，它給了我一些希望和樂觀，但我不能給你具體的數字。

As it relates to the guidance, as I said and Justin, this is our first time giving guidance, we're going to take a very measured approach. I think as we look at how we performed since launch, there's different percentages growth quarter-to-quarter. So we're not going to just straight line thing. We're going to take these in a stepwise fashion as we have with this. And I think this is a measured and appropriate first step for guidance. Justin, anything to add to that?

由於它與指導有關，正如我和賈斯汀所說，這是我們第一次提供指導，我們將採取非常謹慎的方法。我認為，當我們審視自推出以來的表現時，會發現每個季度都有不同的百分比增長。所以我們不會只是直線的事情。我們將像現在這樣逐步採取這些措施。我認為這是一個謹慎且適當的指導第一步。賈斯汀，還有什麼要補充的嗎？

No, Mike, that's excellent. Again, we're really encouraged by Q2's quarter-over-quarter growth in the measured (inaudible) and really to the question (inaudible), and we'll keep you apprised with our progress.

不，邁克，那太好了。再次，我們對第二季度的季度環比增長感到非常鼓舞（聽不清），並且確實解決了這個問題（聽不清），我們將隨時向您通報我們的進展。

And then just one quick question on the Symphony. So the patient assistance program, can you say what percent of the script volume coming out of Symphony was driven by the PAP for which you don't book revenue?

然後是一個關於交響曲的簡單問題。那麼，在患者援助計劃中，您能說一下 Symphony 的腳本量中有多少是由您沒有為其預訂收入的 PAP 驅動的嗎？

Yes. I mean it's going to vary depending upon all the scripts, right? So there's not a specific percentage that we can say is going to be true last quarter to the next one, but it's just a -- it's a PAP program that shows up in Symphony.

是的。我的意思是它會根據所有腳本而有所不同，對吧？因此，我們無法確定上個季度到下個季度的具體百分比，但這只是一個 - 這是 Symphony 中顯示的 PAP 計劃。

And the next question comes from Dennis Ding with Jefferies.

下一個問題來自杰弗里斯的丹尼斯·丁。

Congratulations on the progress. Two, if I may. For XPHOZAH, what are your expectations into the October PDUFA including how the label could eventually shake out and how that would impact your positioning in the market? And then number two, ever since the resubmission and acceptance how have engagement with the FDA been? And what more needs to happen in the next 2 months into the PDUFA?

祝賀取得的進展。如果可以的話，兩個。對於 XPHOZAH，您對 10 月份 PDUFA 有何期望，包括該品牌最終將如何脫穎而出以及這將如何影響您在市場中的定位？第二，自從重新提交並接受以來，與 FDA 的接觸情況如何？在 PDUFA 的未來 2 個月內還需要做什麼？

Sure. So I think as we shared when we said that we had refiled the NDA and as well with Dr. Stein's letter and frankly, all the discussions that occurred at the AdCom, we believe the likelihood is that this is going to be an indication that says something along the lines when binders are insufficient or intolerable, which is the majority of patients, as everyone knows. So I think that secures a very powerful second-line spot where all the binder, it's what, almost 80% of patients are above range in any 6-month period of time. So we feel strong and feel good about if that's the indication ultimately ends up being.

當然。因此，我認為，正如我們所說的，我們已經重新提交了 NDA，以及 Stein 博士的信，坦率地說，還有 AdCom 上發生的所有討論，我們認為這很可能表明，眾所周知，當粘合劑不足或無法耐受時，這是大多數患者的情況。因此，我認為這確保了一個非常強大的二線位置，所有粘合劑，幾乎 80% 的患者在任何 6 個月的時間內都高於範圍。因此，如果這就是最終的結果，我們感覺很堅強並且感覺很好。

There's not really been any substantive communication with the agency, didn't anticipate any. Traditionally, you begin your negotiations on your package insert month or so prior to your PDUFA date. And if you recall in our last go around, we've negotiated the majority of the package insert before what occurred to ultimately end up in the CRL. So I don't know how much relitigation is going to have to be required for the PI since that's already been done. But that's what we would anticipate.

實際上並沒有與該機構進行任何實質性的溝通，也沒有預料到會有任何溝通。傳統上，您會在 PDUFA 日期之前一個月左右開始就包裝說明書進行談判。如果您還記得在我們的上一次審查中，我們已經在最終出現在 CRL 中之前協商了大部分包裝插入內容。所以我不知道 PI 需要進行多少重新訴訟，因為這已經完成了。但這正是我們所期望的。

And the next question comes from Laura Chico with Wedbush.

下一個問題來自 Laura Chico 和 Wedbush。

I just wanted to circle back on the guidance real quick here. What -- I guess, maybe if you could explain, Mike, what gave this -- why was now a good time to start providing guidance? Was there anything that's changed kind of in the trajectory or anything there. But yes, rationale around why now it's a good time for guidance.

我只是想在這裡快速回顧一下指導。什麼——我想，也許你能解釋一下，邁克，是什麼造成了這種情況——為什麼現在是開始提供指導的好時機？軌跡或那裡有什麼改變嗎？但是，是的，關於為什麼現在是指導的好時機的理由。

Well, we said that we would do in about 15 to 18 months from launches. We learn more about the data and got more comfortable. And I think as Justin said in his opening remarks, that we're gaining confidence in those numbers being representative of where we're going. So that's really what generated it. It's 15, 16 months post launch, and it just seemed like the right time. Justin, anything to add.

嗯，我們說過我們會在發布後大約 15 到 18 個月內完成。我們對數據了解得更多，也更舒服。我認為正如賈斯汀在開場白中所說，我們對這些數字代表了我們的發展方向越來越有信心。這就是它產生的真正原因。距離發布已有 15、16 個月了，現在似乎正是合適的時機。賈斯汀，有什麼要補充的嗎？

No, I think that's right. Laura?

不，我認為這是對的。勞拉？

Okay. And then if I could follow up on one just with respect to the legislation, I don't think we've seen text on the bill yet. And I know you mentioned we've already had the can kick down the road 3 times previously. I guess just on the off chance the bill does not progress. I'm just wondering if you could kind of walk through mechanistically what would actually happen if it were included in the bundle? I guess I'm trying to work through the scenario of potential impacts during the transition. Yes, thanks. If there's any color that you could provide.

好的。如果我可以就立法進行跟進，我認為我們還沒有看到該法案的文本。我知道你提到我們之前已經有 3 次可以踢路了。我想，萬一該法案沒有取得進展。我只是想知道您是否可以機械地介紹一下如果它包含在捆綁包中實際會發生什麼？我想我正在嘗試解決過渡期間潛在影響的情況。對了謝謝。如果有什麼顏色可以提供。

Sure. And to see the text of the bill, you can go to Buddy Carter's website, Congressman from Georgia. And the bill is there. As it relates to the bundle, it would end up being January 1, '25 as it goes in and you ultimately are on a 2-year to [date] period. Like other drugs that have gone in something like Sensipar, Parsabiv, they collect the data from that 2-year period and then the following year, they increased their base rate based upon a calculation on those data that they collected to increase the base rate to cover the costs associated with anything going into the bundle. I think what makes these oral-only so unique is that they are not given during the provision of dialysis.

當然。要查看該法案的文本，您可以訪問巴迪卡特的網站，喬治亞州國會議員。賬單就在那裡。由於它與捆綁包相關，因此最終將在 25 年 1 月 1 日生效，並且您最終將處於 2 年至今的時期。與 Sensipar、Parsabiv 等其他藥物一樣，他們收集了這 2 年期間的數據，然後在接下來的一年，他們根據收集的數據進行計算，將基本費率提高到支付與捆綁包中的任何內容相關的費用。我認為這些僅口服藥物的獨特之處在於它們不在透析期間給予。

If you recall or as we talked that, in fact, you're not allowed to eat when you're on dialysis. And certainly our package and certain others say you have to take your drugs while you have food, right, whether it's a meal or a snack in the case of binders, and for us, it's one small pill before breakfast and whether it's dinner or lunch, your next largest meal. So it makes it a vexing issue for the providers to actually accomplish what they need to when they're not going to be getting these drugs during the provision of the balance of services.

如果您還記得，或者正如我們所說，事實上，您在接受透析時不允許進食。當然，我們的包裝和某些其他包裝上都說你必須在吃飯時服用藥物，對吧，無論是一頓飯還是零食（如果是粘合劑），對我們來說，它是早餐前的一小粒藥片，無論是晚餐還是午餐，您的下一頓大餐。因此，當服務提供者在提供平衡服務期間無法獲得這些藥物時，如何真正完成他們需要的工作成為一個令人煩惱的問題。

That's very helpful, Mike. Last question, I'll hop back in the queue. In terms of ATM utilization, I think it was about $11 million generated this quarter. Could you just comment on kind of appetite for further use of the ATM?

這非常有幫助，邁克。最後一個問題，我會跳回到隊列中。就 ATM 利用率而言，我認為本季度產生的金額約為 1100 萬美元。您能否評論一下對進一步使用 ATM 的興趣？

Sure, Justin?

當然可以，賈斯汀？

Yes. Thank you. So we sold approximately 3 million shares during the second quarter for gross proceeds of approximately $11.6 million. As we discussed in our prepared remarks, we're going to hear the (inaudible) and our capital raising ideas. So we're open-minded to non-equity solutions as well as we continue to explore options across both business development, debt and other nonequity solutions. So we have certainly a tool in our toolbox, but we are going to be patient and methodical as we tried to be in the previous quarters that we demonstrated in promotional trial.

是的。謝謝。因此，我們在第二季度出售了大約 300 萬股股票，總收益約為 1160 萬美元。正如我們在準備好的發言中討論的那樣，我們將聽到（聽不清）和我們的融資想法。因此，我們對非股權解決方案持開放態度，並繼續探索業務發展、債務和其他非股權解決方案的選擇。因此，我們的工具箱里肯定有一個工具，但我們將保持耐心和有條不紊，就像我們在前幾個季度的促銷試驗中所展示的那樣。

And the next question comes from Matt Kaplan with Ladenburg Thalmann.

下一個問題來自馬特·卡普蘭和拉登堡·塔爾曼。

Congrats on the IBSRELA results for the quarter, nice results. Just wanted to dive in a little bit more to your preparation for the XPHOZAH launch and going into the October 17 PDUFA. Can you give us a little bit more color in terms of how you're thinking about the build-out of that sales team and will it look like the IBSRELA team or in terms of size and give us a little bit more color as you prep for.

祝賀 IBSRELA 本季度的業績，不錯的結果。只是想進一步深入了解 XPHOZAH 發布和 10 月 17 日 PDUFA 的準備工作。您能否向我們提供更多關於您如何看待該銷售團隊的組建以及它是否像 IBSRELA 團隊或規模方面的信息，並在您準備時向我們提供更多信息為了。

Sure, Susan.

當然，蘇珊。

Yes. Matt, we are -- as we mentioned in our narrative, we have mobilized to prepare for the launch of XPHOZAH. We have the capabilities to ramp up all the marketing, distribution, payer engagement and patient services. Your question on the sales force, we are fielding a dedicated nephrology sales force. And this market, as the IBSRELA, as we have noted around the IBS-C market has a very concentrated number of doctors with around 8,000 HCPs accounting for the majority of hyperphosphatemia scripts.

是的。馬特，正如我們在敘述中提到的，我們已經動員起來為 XPHOZAH 的推出做準備。我們有能力加強所有營銷、分銷、付款人參與和患者服務。你關於銷售隊伍的問題，我們正在部署一支專門的腎髒病銷售隊伍。正如我們在 IBS-C 市場周圍注意到的，這個市場，如 IBSRELA，醫生數量非常集中，大約有 8,000 名 HCP，佔高磷血症病例的大部分。

So to really reach that target group, we are fielding a group of about 60, which we believe really will develop a very -- establish a strong sales force presence for XPHOZAH with a dedicated nephrology sales force across the country. So it really is a sales force comparable in size to our IBSRELA sales force.

因此，為了真正達到這一目標群體，我們正在部署大約 60 人的團隊，我們相信這確實將為 XPHOZAH 建立一支強大的銷售隊伍，在全國范圍內擁有一支專門的腎髒病銷售隊伍。因此，它確實是一支規模與我們的 IBSRELA 銷售隊伍相當的銷售隊伍。

However, it is dedicated to the nephrology call point, and we are experiencing a really high level of interest because we're interviewing to fill those spots as we speak, with very seasoned salespeople with -- coming in with nephrology experience and established relationships. So we're quite enthusiastic about launching this dedicated team, and we will be prepared to be able to launch as quickly as possible upon the approval of XPHOZAH in the fourth quarter.

然而，它是專門針對腎髒病學呼叫點的，我們對此非常感興趣，因為我們正在採訪以填補這些空缺，而經驗豐富的銷售人員則擁有腎髒病學經驗和已建立的關係。因此，我們非常熱衷於啟動這個專門的團隊，我們將準備好在第四季度獲得 XPHOZAH 的批准後儘快啟動。

And Matt, the thing I would add to that is if you recall, before the CRL, we had an extensive disease awareness campaign in an organization that was feet on the ground doing that. And what's been remarkable is to see the continued awareness that has built even since then in the anticipation for it. So we're enthusiastic about what we're going to be launching into.

馬特，我要補充的是，如果你還記得的話，在 CRL 之前，我們在一個腳踏實地做這件事的組織中開展了廣泛的疾病意識活動。值得注意的是，從那時起人們就一直在期待它的到來。因此，我們對即將推出的產品充滿熱情。

That's helpful. And then a follow-on to that is, I guess, why should the XPHOZAH launch look like the IBSRELA launch? Or why should it look different given, I guess, given what you just said, Mike, in terms of the level of awareness, et cetera. What should our expectations be in terms of the trajectory of the [launch]?

這很有幫助。我想，接下來的問題是，為什麼 XPHOZAH 的發布看起來應該像 IBSRELA 的發布？或者，我想，考慮到你剛才所說的，邁克，在意識水平等方面，為什麼它看起來應該有所不同。我們對[發布]的軌跡應該有什麼期望？

Yes. So I think what we'll do is hold on, Matt. We will spend some more time, more dedicated time with everyone as we get closer to the PDUFA date, telling you more about our expectations and how that's going to look. I think we're still gathering perspectives on it. We think it's going to be a positive response to the launch, but quantifying that at this stage is probably premature.

是的。所以我想我們要做的就是堅持下去，馬特。隨著 PDUFA 日期的臨近，我們將花更多的時間、更專注的時間與大家在一起，告訴您更多關於我們的期望以及未來的情況。我認為我們仍在收集對此的看法。我們認為這將是對發布的積極回應，但現階段對此進行量化可能還為時過早。

Okay. Fair enough. And last question in terms of the prep for the launch. I think in your prepared remarks, Justin, you mentioned incremental increase in SG&A. Can you just go over that again? And how we should think about that?

好的。很公平。最後一個問題是關於發布準備工作的。賈斯汀，我認為在您準備好的發言中，您提到了 SG&A 的增量增長。你能再說一遍嗎？我們應該如何思考這個問題？

Yes. Thank you, Matt. So we'd like to guide that we anticipate an additional incremental $20 million in combined SG&A spend with well as some additional product supply spend starting in this quarter and going on. That will be the incremental cost. Of course, once the targeted margin we're generating revenue there will be offset by the proceeds from net revenue. But we're guiding you to an incremental $20 million in the quarter, respectively.

是的。謝謝你，馬特。因此，我們希望指出，我們預計從本季度開始並持續增加 2000 萬美元的綜合 SG&A 支出以及一些額外的產品供應支出。這將是增量成本。當然，一旦我們產生收入達到目標利潤，就會被淨收入收益所抵消。但我們將指導您在本季度分別增加 2000 萬美元。

(Operator Instructions) And the next question comes from Peyton Bohnsack with TD Cowen.

（操作員說明）下一個問題來自 TD Cowen 的 Peyton Bohnsack。

I guess a little more on the PDUFA that you mentioned. So I'm assuming that you have to apply for this. Is my assumption that you guys would apply for this if it wasn't put in the bundle, however, mix on, Mike, that maybe.

我想對你提到的 PDUFA 有更多了解。所以我假設你必須申請這個。我的假設是，如果它沒有放入捆綁包中，你們會申請這個，但是，混合一下，邁克，也許吧。

Yes. I mean, whatever the process is to get those data collected, we would certainly participate in that.

是的。我的意思是，無論收集這些數據的過程是什麼，我們肯定會參與其中。

Okay. Got you. And then I guess it's kind of like a follow-up, how have kind of discussions been going for other areas like specifically Europe. Have you begun to move forward [with maybe those]? And if you have any time line, that would be great.

好的。明白你了。然後我想這有點像後續行動，其他地區（特別是歐洲）的討論進展如何。你已經開始（也許是那些）繼續前進了嗎？如果你有任何時間表，那就太好了。

Yes. So we've had ongoing discussions in all the unpartnered territories, whether it's IBS-C and Japan, Europe, rest of world, those conversations continue with some. There is a better trajectory than others. No specific time line that I can give you in terms of when anything like that would be finalized.

是的。因此，我們在所有未合作的地區進行了持續的討論，無論是 IBS-C 以及日本、歐洲、世界其他地區，這些對話仍在與一些地區繼續進行。有比其他人更好的軌跡。我無法給出具體的時間表來說明此類事情何時最終確定。

Great. And I guess, just like one final one for me, seeing how you guys are pretty deep into the IBSRELA launch now and they both will probably going to get approved and then launched. Could you maybe talk about your long-term P&D or internal R&D strategy? Would you guys restart your earlier-stage pipeline? Or would you be looking to license something?

偉大的。我想，就像我的最後一項一樣，看到你們現在對 IBSRELA 的推出非常深入，它們都可能會獲得批准然後推出。您能談談您的長期研發或內部研發戰略嗎？你們會重新啟動早期階段的管道嗎？或者您會尋求許可某些東西嗎？

Yes. I mean it's a great question. As we've said, there's a couple of programs that are sort of laying fallow at this point because both the metabolic acidosis, the hyperkalemia program to speak of 2 that with sufficient capital, obviously, looking at those and restarting those would be a prudent thing to do. I think what we're also demonstrating, Peyton was, what we've done with IBSRELA and I'm confident we'll demonstrate with XPHOZAH is an extraordinarily powerful commercial organization that should be the partner of choice for new and upcoming drugs in IBS and even upcoming drugs in dialysis (inaudible). So we'll continue looking across multiple ways of strengthening our pipeline as we get to a place where we have a strong enough balance sheet to do that.

是的。我的意思是這是一個很好的問題。正如我們所說，目前有幾個項目處於閒置狀態，因為代謝性酸中毒和高鉀血症項目 2 都有足夠的資金，顯然，考慮這些項目並重新啟動這些項目將是謹慎的做法要做的事。我認為 Peyton 還展示了我們在 IBSRELA 上所做的事情，我相信我們將與 XPHOZAH 一起展示的是一個非常強大的商業組織，應該成為 IBS 新藥和即將推出的藥物的首選合作夥伴甚至即將推出的透析藥物（聽不清）。因此，當我們擁有足夠強大的資產負債表來做到這一點時，我們將繼續尋找多種方法來加強我們的管道。

And this concludes our question-and-answer session. I'd like to return the conference back over to President and CEO, Mike Raab, for any closing comments.

我們的問答環節到此結束。我想將會議交還給總裁兼首席執行官邁克·拉布 (Mike Raab)，徵求結束語。

Thank you, everyone, for joining us this morning. I look forward to providing you with further updates in the weeks and months ahead. We have a number of milestones that I look forward to sharing, including an approval of XPHOZAH in October and continued growth of IBSRELA.

謝謝大家今天早上加入我們。我期待在未來幾周和幾個月內為您提供進一步的更新。我期待與大家分享我們的許多里程碑，包括 10 月份 XPHOZAH 的批准以及 IBSRELA 的持續增長。

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

這樣，我們就可以結束通話了。謝謝你，接線員。

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

謝謝。會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。