Ardelyx Inc (ARDX) 2024 Q2 法說會逐字稿

Good afternoon and welcome to the Ardelyx second quarter 2024 conference call.

下午好，歡迎參加 Ardelyx 2024 年第二季電話會議。

(Operator Instructions)

（操作員說明）

Please note today's event is being recorded. 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.

請注意今天的活動正在錄製中。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 our second quarter 2024 financial results call. During the call, we'll refer to the press release issued earlier today, which is available on the Investors section of the company's website at Ardelyx.com.

謝謝。下午好，歡迎我們召開 2024 年第二季財務業績電話會議。在電話會議期間，我們將參考今天稍早發布的新聞稿，該新聞稿可在公司網站 Ardelyx.com 的投資者部分取得。

During this call, we'll 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 that risk factor in our most recent quarterly report on 10-Q that was filed today and can be found on our website 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，我們將做出前瞻性陳述，這些陳述存在風險和不確定性。我們的實際結果可能與描述的結果有重大差異。我們鼓勵您在今天提交的最新 10-Q 季度報告中查看該風險因素，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，即使我們的觀點改變。

Our President and CEO, Mike Raab, and Chief Financial and Operations Officer, Justin Renz, will share prepared remarks before we open the call to questions. I will now hand the call over to Mike.

我們的總裁兼執行長 Mike Raab 以及財務與營運長 Justin Renz 將在我們開始提問之前分享準備好的發言。我現在將電話轉交給麥克。

Thank you, Caitlin, and good afternoon, everyone. It is great to be back together to discuss another quarter's strong performance. Across all fronts, we continue to drive exceptional progress. IBSRELA's growth momentum continued at a strong pace with another quarter of meaningful gains with revenue growing 25% compared to the first quarter of 2024, and nearly doubled compared to the second quarter of last year. This performance demonstrates the important role IBSRELA is playing addressing the large unmet need among patients with IBS-C.

謝謝凱特琳，大家下午好。很高興能再次聚在一起討論另一個季度的強勁表現。在各個方面，我們繼續推動卓越的進步。IBSRELA 的成長勢頭繼續強勁，又一個季度實現了有意義的增長，收入與 2024 年第一季相比增長了 25%，與去年第二季度相比幾乎翻了一番。這一表現表明 IBSRELA 在解決 IBS-C 患者巨大的未滿足需求方面發揮著重要作用。

Every month, we continue to see increases in new and repeat writers as well as new and refill prescriptions. Healthcare providers see their patients having positive experiences with IBSRELA, and are expanding the number of patients in their practices for whom they prescribe. Our market access and affordability program, ArdelyxAssist, provides a straightforward path for patients to access IBSRELA.

每個月，我們都會看到新寫手和重複寫手以及新處方和續配處方的數量不斷增加。醫療保健提供者看到他們的患者對 IBSRELA 有積極的體驗，並正在擴大他們為其開處方的患者數量。我們的市場准入和負擔能力計劃 ArdelyxAssist 為患者獲得 IBSRELA 提供了一條簡單的途徑。

IBSRELA is an important and effective treatment option that is bringing relief to more and more patients who, despite previous treatment, continue to experience the debilitating symptoms of IBS-C. The potential for IBSRELA is significant and reinforces our conviction that it can achieve at least a 10% share of the IBS prescription market and as well on the path to becoming a $1 billion product before patent expiry.

IBSRELA 是一種重要且有效的治療選擇，它正在為越來越多的患者帶來緩解，儘管他們之前接受過治療，但仍繼續經歷 IBS-C 的衰弱症狀。IBSRELA 的潛力巨大，使我們更加堅信它可以在 IBS 處方市場佔據至少 10% 的份額，並有望在專利到期前成為價值 10 億美元的產品。

The launch of XPHOZAH has been remarkable and makes it abundantly clear that patients have needed a different option to manage their phosphorus when binders are insufficient or not well tolerated. Nephrologists are responding favorably to the benefit XPHOZAH is providing their patients and are increasingly integrating XPHOZAH into their therapeutic regimens.

XPHOZAH 的推出非常引人注目，它清楚地表明，當結合劑不足或耐受性不佳時，患者需要不同的選擇來管理磷。腎臟病專家對 XPHOZAH 為患者帶來的益處做出了積極回應，並越來越多地將 XPHOZAH 納入他們的治療方案中。

The consistent feedback from the field is that healthcare practitioners are seeing serum phosphorous improvements in their patients, many for the first time as a result of XPHOZAH. These dynamics are translating into significant growth for XPHOZAH in only the second full quarter since launch.

來自該領域的一致反饋是，醫療保健從業者看到患者的血清磷有所改善，其中許多人是第一次因 XPHOZAH 而改善。自推出以來，這些動態僅在第二個完整季度就轉化為 XPHOZAH 的顯著成長。

Throughout the development and commercialization of this important therapy, we've demonstrated how vital it is for us to assume the role we have to advocate for the rights of CKD patients on dialysis. As we discussed during our call in July, we believe that moving XPHOZAH into the Medicare bundle looks severely restrict and effectively eliminate access to XPHOZAH for all patients.

在這項重要療法的開發和商業化過程中，我們已經證明，承擔起倡導 CKD 透析患者權利的角色是多麼重要。正如我們在 7 月的電話會議中討論的那樣，我們認為將 XPHOZAH 納入 Medicare 捆綁包似乎會嚴重限制並有效地消除所有患者對 XPHOZAH 的使用。

To allow patients who are now and may the future benefit from XPHOZAH to no longer have access to the therapy due to a misguided government payment policy is not acceptable. We believe that CMS is not acting in the best interest of patients and has instead ignored the countless voices from patient, physician provider communities who have clearly and consistently communicated that oral-only phosphate lowering therapies do not belong in the bundle.

由於政府支付政策的誤導，讓現在和將來可能從 XPHOZAH 受益的患者不再獲得該治療是不可接受的。我們認為 CMS 的行為並不符合患者的最佳利益，而是忽視了來自患者、醫生提供者社區的無數聲音，他們明確一致地表示，純口服降磷酸鹽療法不屬於捆綁療法。

As we have announced in the past months, we have chosen to advocate for patient access to XPHOZAH across numerous forms. First is the Kidney Patient Act. There is significant support for this bill across multiple stakeholder groups, and we call on Congress to act and pass this bipartisan-bicameral legislation and protect access to all phosphate lowering therapies for all dialysis patients.

正如我們在過去幾個月所宣布的那樣，我們選擇倡導患者透過多種形式獲得 XPHOZAH。首先是《腎臟病患者法》。該法案得到了多個利益相關者團體的大力支持，我們呼籲國會採取行動並通過這項兩黨兩院立法，並保護所有透析患者獲得所有降磷療法。

Second, we announced in mid-July that we filed a lawsuit claiming that CMS' plan to move oral-only phosphate lowering therapies, including XPHOZAH, into the bundle is unlawful and oversteps at statutory and regulatory authority.

其次，我們在 7 月中旬宣布提起訴訟，聲稱 CMS 將包括 XPHOZAH 在內的純口服降磷酸鹽療法納入捆綁銷售的計劃是非法的，並且超越了法定和監管機構的規定。

In addition, the complaint argues that the plan is incompatible with CMS' own regulations, saying that renal dialysis services do not include those services that are not essential for the delivery of maintenance dialysis. We seek relief under the administrative procedure ad to enjoy CMS for proceeding with its plan to include XPHOZAH in the bundle and thus eliminate coverage for patients under Medicare Part D beginning January 1, 2025.

此外，投訴稱該計劃不符合 CMS 自己的規定，並表示腎臟透析服務不包括那些對於提供維持性透析並不重要的服務。我們根據行政程序廣告尋求救濟，以享受 CMS 繼續實施將 XPHOZAH 納入捆綁計劃的計劃，從而從 2025 年 1 月 1 日開始取消 Medicare D 部分患者的承保範圍。

We are honored to be joined in this lawsuit by the American Association of Kidney Patients, the nation's largest independent kidney patient organization and the National Minority Quality Forum, the nation's largest minority healthcare research, education and advocacy organization. Their partnership demonstrates just how significant of an impact this policy will have on patients and how critical it is that we protect patient choice and timely access to phosphate lowering therapies.

我們很榮幸能與美國腎臟病患者協會（美國最大的獨立腎臟病患者組織）和全國少數族裔品質論壇（美國最大的少數族裔醫療保健研究、教育和倡導組織）一起參與這場訴訟。他們的合作關係表明，這項政策將對患者產生多麼重大的影響，以及我們保護患者的選擇和及時獲得降磷治療的重要性。

We are still early in the process and cannot share details regarding our expectations of timing or success. At this point, we await confirmation that a government lawyer has been assigned to the case, and then we will be able to commence discussions regarding the timeline. We are hopeful that there can be some action before the end of the year on the case.

我們仍處於過程的早期階段，無法分享有關我們對時間或成功的期望的詳細資訊。目前，我們正在等待政府律師已被指派處理此案的確認，然後我們將能夠開始討論時間表。我們希望在今年年底前對此案採取一些行動。

Third, with our decision not to apply for TDAPA, we believe that we are able to continue making progress on our strategy to maximize patient access to XPHOZAH. As we learn more and make decisions, we are committed to communicating to you as comprehensively as possible. I hope that what you can take away from our past actions and from our approach is that we will exhaust all options available to us to protect patient access to XPHOZAH and to protect our business.

第三，由於我們決定不申請 TDAPA，我們相信我們能夠繼續在我們的策略上取得進展，以最大限度地提高患者獲得 XPHOZAH 的機會。隨著我們了解更多並做出決定，我們致力於盡可能全面地與您溝通。我希望您能從我們過去的行動和方法中學到的是，我們將竭盡全力保護患者獲得 XPHOZAH 的機會並保護我們的業務。

What should be clear from my remarks and from Justin's to come is that our business is growing and our performance during the second quarter demonstrates the strong fundamentals driving this growth, delivering on our priorities, executing our disruptive commercial and market access approach, and remaining committed to the Ardelyx mission of putting patients first. Our two first-in-class medicines are bringing meaningful benefits to patients. We are well capitalized, and we are focused on our future, both in terms of our current products as well as pipeline expansion.

從我的演講和賈斯汀接下來的演講中應該清楚的是，我們的業務正在增長，第二季度的業績表明了推動這一增長的強勁基本面，實現了我們的優先事項，執行了我們顛覆性的商業和市場准入方法，並保持了承諾以患者為先的 Ardelyx 使命。我們的兩種一流藥物正在為患者帶來有意義的益處。我們資本充足，並且專注於我們的未來，無論是在我們目前的產品還是在管道擴張方面。

I will now turn the call to Justin, who will walk through the details of our financial performance. Justin?

我現在將把電話轉給賈斯汀，他將詳細介紹我們的財務表現。賈斯汀？

Thank you, Mike. I'm very pleased to be ready to discuss the second quarter performance we reported earlier today, which included significant growth for both of our commercial products and thoughtful management of our finances, while maintaining a strong balance sheet.

謝謝你，麥克。我很高興準備討論我們今天早些時候報告的第二季度業績，其中包括我們的商業產品的顯著增長和對財務的周到管理，同時保持強勁的資產負債表。

Let's start with revenue. We reported significant year-over-year revenue growth during the second quarter, totaling $73.2 million. That is compared to $22.3 million of total revenue during the same period in 2023. This growth reflects incredibly strong performances from both IBSRELA and XPHOZAH, which together totaled $72.6 million in net product sales revenue in the second quarter of 2024 compared to $18.3 million in net product sales revenue coming from IBSRELA alone in the second quarter of 2023.

讓我們從收入開始。我們報告第二季度營收同比顯著增長，總計 7,320 萬美元。相較之下，2023 年同期的總收入為 2,230 萬美元。這一成長反映了IBSRELA 和XPHOZAH 令人難以置信的強勁業績，它們在2024 年第二季度的產品淨銷售收入總計為7260 萬美元，而2023 年第二季度僅IBSRELA 的產品淨銷售收入為1830 萬美元。

Before I jump in, I'd like to take a moment to share our perspective on the publicly available prescription data for IBSRELA and XPHOZAH, as many of you ask how to best consider those data in relation to our revenue. First, as you know, our net sales revenue was based upon bottle shipments to our distributors and is not directly linked to prescription-level data available from Symphony or IQVIA. As we've discussed, our distributors and pharmacies keep winded amounts of product in the channel, essentially just-in-time inventory management.

在開始之前，我想花點時間分享我們對 IBSRELA 和 XPHOZAH 公開處方數據的看法，因為你們中的許多人都想知道如何最好地考慮與我們收入相關的這些數據。首先，如您所知，我們的淨銷售收入是基於向經銷商出貨的瓶子，與 Symphony 或 IQVIA 提供的處方級資料沒有直接關聯。正如我們所討論的，我們的經銷商和藥局在通路中保留了大量的產品，本質上是即時庫存管理。

I encourage you to use some caution as information from prescription data providers can be incomplete and inconsistent, especially for medicines like IBSRELA and XPHOZAH as a result of our market access and distribution strategy that relies on the critical relationship between HCPs, specialty pharmacies, and ArdelyxAssist. Remember, too, that not all prescriptions are a 30-day supply, some are 60-day and some are 90-day supply. We understand the desire to use those data, but we want you to consider these dynamics moving forward.

我鼓勵您謹慎行事，因為處方資料提供者提供的資訊可能不完整且不一致，特別是對於IBSRELA 和XPHOZAH 等藥物，因為我們的市場准入和分銷策略依賴HCP、專業藥房和ArdelyxAssist 之間的關鍵關係。也要記住，並非所有處方都是 30 天的用量，有些是 60 天的用量，有些是 90 天的用量。我們理解使用這些數據的願望，但我們希望您考慮這些未來的動態。

With IBSRELA, we began providing with revenue guidance when we were comfortable, and we were able to provide a solid expectation of the future performance of the product. We will provide similar guidance even for XPHOZAH when we have a solid perspective of our future expectations. For the second quarter of 2024, net product sales revenue for IBSRELA was $35.4 million, nearly doubling the $18.3 million in revenue we reported during the same period last year and 25% quarter-over-quarter growth compared to the first quarter of 2024.

透過 IBSRELA，我們開始在我們感到滿意的時候提供收入指導，並且我們能夠對產品的未來表現提供可靠的預期。當我們對未來的期望有明確的認識時，我們甚至將為 XPHOZAH 提供類似的指導。2024 年第二季度，IBSRELA 的產品淨銷售收入為 3,540 萬美元，幾乎是我們去年同期報告的收入 1,830 萬美元的兩倍，與 2024 年第一季相比季增 25%。

IBSRELA's performance was due to strong volume growth resulting from demand driven by our commercial focus and increasing both depth and breadth of writing. That focus continues to translate into growth in new and refill prescriptions as well as expansion of new and repeat writers. We also benefited from the expected improvement in our gross to net deduction for IBSRELA, which decreased from 33.5% in the first quarter this year to 29.7% in the second quarter. As we have seen over the past two years, we expect to gradually improve over the remainder of the year.

IBSRELA 的業績歸功於我們的商業重點驅動的需求以及寫作深度和廣度的增加所帶來的強勁銷售成長。這種關注繼續轉化為新處方和補充處方的成長，以及新處方和重複處方的擴大。我們也受惠於 IBSRELA 總扣除額與淨扣除額的預期改善，從今年第一季的 33.5% 下降到第二季的 29.7%。正如我們過去兩年所看到的那樣，我們預計在今年剩餘時間內將逐步改善。

We are in the final stages of completing the expansion of the IBSRELA sales team. The IBS-C market has responded very favorably to IBSRELA product and clinical profile and our marketing efforts. It is also clear that increasing exposure and frequency of messaging to our target healthcare providers generates new writers and expands the number of patients treated by existing writers.

我們正處於完成 IBSRELA 銷售團隊擴張的最後階段。IBS-C 市場對 IBSRELA 產品和臨床概況以及我們的行銷工作反應非常正面。同樣明顯的是，向我們的目標醫療保健提供者發送訊息的曝光度和頻率的增加會產生新的作家，並擴大現有作家治療的患者數量。

We expect the expanded sales team to begin having an impact later this quarter. As we consider the second half of the year, the fundamentals driving IBSRELA performance remain. We anticipate continued strong quarter-over-quarter growth for the remainder of this year, and we reiterate our guidance. We expect full year 2024 IBSRELA US net product sales revenue will be between $140 million and $150 million.

我們預計擴大的銷售團隊將在本季稍後開始產生影響。當我們考慮今年下半年時，推動 IBSRELA 業績的基本面依然存在。我們預計今年剩餘時間將持續強勁的季度環比成長，並重申我們的指導。我們預計 2024 年全年 IBSRELA 美國產品淨銷售收入將介於 1.4 億美元至 1.5 億美元之間。

Now turning to XPHOZAH. XPHOZAH continued its exceptional performance, reporting $37.1 million in second quarter net product sales revenue, up from $15.2 million we reported in the first quarter of the year. Growth continues to be driven by strong demand from healthcare providers who have a clear need for a new and different option for dialysis patients to help them achieve target phosphorus levels. In addition to strong demand for XPHOZAH, our gross to net deduction improved from 23.8% in the first quarter to 21.4% for the second quarter period.

現在轉向 XPHOZAH。XPHOZAH 繼續保持出色的業績，第二季產品淨銷售收入為 3,710 萬美元，高於我們今年第一季報告的 1,520 萬美元。醫療保健提供者的強勁需求持續推動成長，他們明確需要為透析患者提供新的、不同的選擇，以幫助他們達到目標磷水平。除了對 XPHOZAH 的強勁需求外，我們的總扣除額從第一季的 23.8% 提高到第二季的 21.4%。

As is the case for IBSRELA, the primary deduction is reflected in our gross to net for XPHOZAH, on the standard fees to our distributors, rebates and discounts to government payers and costs associated with our commercial co-pay program. And consistent with our distribution and market access strategy, we do not contract to provide rebates to payers and pharmacy benefit managers. Commercial patients who have an out-of-pocket co-pay cost may have their co-pay requirements covered. Thus, the impact on our gross to net is highly dependent on our payer mix and utilization of our commercial co-pay program.

與 IBSRELA 的情況一樣，主要扣除額反映在 XPHOZAH 的毛淨額、分銷商的標準費用、政府付款人的回扣和折扣以及與我們的商業自付費用計劃相關的成本中。根據我們的分銷和市場准入策略，我們不簽訂合約向付款人和藥品福利管理者提供回饋金。需要自付費用的商業患者的自付費用可能會得到滿足。因此，對我們毛淨額的影響在很大程度上取決於我們的付款人組合和商業自付費用計劃的利用。

We are very pleased with these results to date. As we continue to learn more about the patient and payer mix that impacts the calculation, we will provide our expectations for the gross to net deduction as we do with IBSRELA. We are very pleased with our top line results during the quarter. Our commercial approach is working, and our teams are executing the highest level to build and maintain the growth momentum we've established with both IBSRELA and XPHOZAH.

我們對迄今為止的這些結果感到非常滿意。隨著我們繼續更多地了解影響計算的患者和付款人組合，我們將提供總扣除額與淨額扣除額的預期，就像我們對 IBSRELA 所做的那樣。我們對本季的營收結果非常滿意。我們的商業方法正在發揮作用，我們的團隊正在執行最高水準的工作，以建立和維持我們與 IBSRELA 和 XPHOZAH 建立的成長勢頭。

Now for the expense and cash side. Throughout the second quarter, we continue to be thoughtful on how we manage our expenses. Research and development expenses were $12.8 million compared to $8.3 million during the second quarter of 2023. This increase reflected expanded field-based medical affairs teams focused on the gastroenterology and nephrology communities.

現在來說說費用和現金方面。在整個第二季度，我們繼續深思熟慮如何管理費用。研發費用為 1,280 萬美元，而 2023 年第二季為 830 萬美元。這一增長反映了專注於胃腸病學和腎臟病學領域的現場醫療事務團隊的擴大。

Selling, general and administrative expenses were $64.7 million for the second quarter compared to $27.2 million for the same period of 2023. The increase was related to commercial launch activities for XPHOZAH, investments to grow IBSRELA throughout last year as well as the extension of the IBSRELA sales team that I just spoke to, and which occurred primarily during the second quarter of this year. As I previously communicated, we expect our SG&A run rate once the expansion is complete to be approximately $80 million per quarter.

第二季的銷售、一般和管理費用為 6,470 萬美元，而 2023 年同期為 2,720 萬美元。這一成長與 XPHOZAH 的商業啟動活動、去年全年發展 IBSRELA 的投資以及我剛剛採訪過的 IBSRELA 銷售團隊的擴展有關，這主要發生在今年第二季度。正如我之前所說，擴張完成後，我們預計 SG&A 運行率約為每季 8000 萬美元。

Substantial top line growth, combined with thoughtful cost management, resulted in a net loss of approximately $16.5 million or $0.07 per share compared to a net loss of $17.1 million or $0.08 per share in the same period of 2023. Our $16.5 million net loss for the second quarter of 2024 included $12.3 million in combined non-cash expenses from share-based compensation and non-cash interest expense related to the sale of future royalties.

營收的大幅成長，加上周到的成本管理，導致淨虧損約 1,650 萬美元，即每股 0.07 美元，而 2023 年同期的淨虧損為 1,710 萬美元，即每股 0.08 美元。我們 2024 年第二季的 1,650 萬美元淨虧損包括來自股權激勵的 1,230 萬美元非現金合併費用以及與出售未來特許權使用費相關的非現金利息費用。

We finished the second quarter in a strong cash position. As of June 30, 2024, we had total cash, cash equivalents, and short-term investments of $186 million as compared to $184.3 million at the end of 2023. We did not engage in any fundraising activities during Q2. However, as a reminder, we drew the $50 million tranche proceeds from our debt agreement with SLR Capital back in March.

第二季結束時，我們的現金狀況良好。截至 2024 年 6 月 30 日，我們的現金、現金等價物及短期投資總額為 1.86 億美元，而 2023 年底為 1.843 億美元。第二季我們沒有進行任何籌款活動。不過，提醒一下，我們早在 3 月就從與 SLR Capital 的債務協議中提取了 5,000 萬美元的部分收益。

We are pleased with our performance during the second quarter, driving continued substantial top line growth across our product lines, managing our operating expenses, and maintaining a strong balance sheet. We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value.

我們對第二季的業績感到滿意，推動我們產品線的收入持續大幅成長，管理我們的營運費用，並保持強勁的資產負債表。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. Q2 was a remarkable quarter. We demonstrated significant growth for both our products, and we shared our perspectives on the impact of oral-only drugs entering the Medicare bundle and our commitment and plans to fight for patients. We are considering all options and making progress, yet we still have a lot of work to do. We do not fight alone.

謝謝，賈斯汀。第二季是一個非凡的季度。我們的兩種產品都顯示了顯著的增長，我們分享了我們對純口服藥物進入醫療保險捆綁包的影響的看法，以及我們為患者而奮鬥的承諾和計劃。我們正在考慮所有選擇並取得進展，但我們仍然有很多工作要做。我們並不是孤軍奮戰。

I would like to extend my sincere thanks to our many partners, physicians, patients, and advocates as well as all of team Ardelyx who are lending their voices to the important work we have ahead of us to protect patient access to XPHOZAH. The past few weeks have demonstrated just how aligned we all are in supporting patients and making sure that they have access to innovative therapies. We have a team in place to deliver and we will continue to update you as developments occur and progress is made. We appreciate your support as we move through the next few months.

我謹向我們的眾多合作夥伴、醫生、患者和倡導者以及所有 Ardelyx 團隊致以誠摯的謝意，他們為我們面前的重要工作發聲，以保護患者獲得 XPHOZAH。過去幾週的情況表明，我們所有人在支持患者並確保他們獲得創新療法方面是多麼一致。我們有一個團隊來提供服務，隨著事態的發展和取得的進展，我們將繼續向您通報最新情況。在我們接下來的幾個月裡，我們感謝您的支持。

I will now open the call to questions. Operator?

我現在開始提問。操作員？

(Operator Instructions)

（操作員說明）

Louise Chen, Cantor.

路易絲·陳，康托爾。

Hi, congratulations on the quarter and thank you for taking my questions. So first question I have for you was on XPHOZAH. Obviously, the sales were very strong, and you mentioned something from a gross to net perspective that it sounded like it may create some volatility quarter-to-quarter. So just curious how you think we should model or think about forecasting the product going forward? And I just wanted to confirm, it sounds like there was not any inventory build, but I just wanted to confirm that there wasn't anything like that. Thank you.

您好，恭喜本季取得成功，感謝您回答我的問題。我要問你的第一個問題是關於 XPHOZAH 的。顯然，銷售非常強勁，您提到從毛額到淨值的角度來看，這聽起來可能會造成季度與季度之間的一些波動。所以只是好奇您認為我們應該如何建模或考慮預測未來的產品？我只是想確認一下，聽起來好像沒有任何庫存建設，但我只是想確認不存在類似的事情。謝謝。

Hey, Louise, thanks for the question. Justin will go into some detail on it. But I think really what we're trying to communicate there is as we did with IBSRELA, giving specifics on guidance is premature at this stage for XPHOZAH as we're learning the ins and outs of what's happening. Justin, if you can provide some perspective too?

嘿，路易絲，謝謝你的提問。賈斯汀將對此進行詳細介紹。但我認為我們真正想要傳達的是，就像我們與 IBSRELA 所做的那樣，對於 XPHOZAH 來說，在現階段提供具體指導還為時過早，因為我們正在了解正在發生的事情的來龍去脈。賈斯汀，你也能提供一些觀點嗎？

Sure. Thanks, Louise. Both products continue to have low amount of inventory in the channel. So that's been very consistent throughout the course of actually both product launches. And from a gross-to-net perspective, the largest variables in our commercial co-pay program. And so there's been some mild fluctuation. And of course, as Mike suggested, it is sensitive to the payer mix. So we can do more and more and more about how that goes. But we're pleased with what we've seen so far.

當然。謝謝，路易絲。這兩種產品的通路庫存量仍然較低。因此，這在實際上這兩種產品的發布過程中都是非常一致的。從總額到淨額的角度來看，我們的商業自付額計畫中最大的變數。所以出現了一些輕微的波動。當然，正如麥克所建議的，它對付款人組合很敏感。因此，我們可以針對事情的進展做越來越多的事情。但我們對迄今為止所看到的情況感到滿意。

And maybe if I could just ask one more question here. I was curious with respect to XPHOZAH and your initiatives to keep it out of the CMS bundle. I know you sued CMS, what other initiatives could you take to fulfill what you're trying to do? Thank you.

也許我可以在這裡再問一個問題。我對 XPHOZAH 以及你們將其排除在 CMS 捆綁之外的舉措感到好奇。我知道您起訴了 CMS，您還可以採取哪些其他舉措來實現您想要做的事情？謝謝。

Well, I think with the work that we're doing still ongoing, so it's premature to go into any of that. There's a lot of work going on behind the scenes. I think as you've seen Louise, we will exhaust all options to make sure that patients continue to have access to these drugs.

嗯，我認為我們正在做的工作仍在進行中，所以現在討論這些還為時過早。幕後有很多工作正在進行。我認為正如您所看到的路易斯，我們將用盡所有選擇來確保患者繼續獲得這些藥物。

Okay, thanks.

好的，謝謝。

Yigal, Citi.

伊格爾，花旗。

Yeah, hi. Thank you very much. Just if we could follow on the inventory question. Is it possible that you could provide any quantification of what the low inventory looks like for both products? And then on the SG&A, you mentioned, Justin, I think, $80 million run rate per quarter. Can you comment on when you would get to that point? Thanks.

是的，嗨。非常感謝。如果我們能跟進庫存問題就好了。您是否可以提供這兩種產品的低庫存情況的量化數據？然後，關於 SG&A，你提到，賈斯汀，我想，每季運行率為 8000 萬美元。您能評論一下您什麼時候會達到這一點嗎？謝謝。

Sure. So on the latter, so SG&A was $64.7 million in the second quarter, which reports include non-cash stock compensation expense and we continue to add to the sales force. So we expect to get to -- as we build the sales force that we're almost done with the ramp-up of the IBSRELA sales team, we should hit that $80 million level in the fourth quarter of this year. In terms of inventory in the channel, both products have been very consistently low. We have a very tight distribution channel. And so there's obviously some variability on a specialty pharmacy and specialty pharmacy basis. But in general, we've been in that 1.5 to 2.5 maximum, and we're closer to two weeks tops in the channel on a regular basis.

當然。對於後者，第二季的 SG&A 為 6,470 萬美元，其中包括非現金股票補償費用，我們將繼續增加銷售團隊。因此，我們預計，隨著 IBSRELA 銷售團隊的壯大，我們的銷售團隊建設即將完成，我們應該在今年第四季達到 8000 萬美元的水平。就通路庫存而言，這兩種產品一直處於較低水準。我們有非常嚴格的分銷管道。因此，專業藥房和專業藥房的基礎上顯然存在一些差異。但總的來說，我們已經處於 1.5 到 2.5 的最大值，我們定期接近該通道的兩週頂部。

Okay, thank you very much.

好的，非常感謝。

Dennis Ding, Jefferies.

丹尼斯丁，傑弗里斯。

Hi. Thanks for taking our questions and congrats on a really strong second quarter. So I had a question on IBSRELA. You guys have been obviously expanding your sales force since earlier this year. Just wondering how much of second quarter's performance stemmed from some of these new sales reps and to be expecting an inflection in the second half as you complete some of these new hires? And maybe you can comment on when you expect those new hires to be hired?

你好。感謝您回答我們的問題，並祝賀第二季度的強勁表現。所以我有一個關於 IBSRELA 的問題。自今年早些時候以來，你們顯然一直在擴大銷售團隊。只是想知道第二季的業績有多少來自於這些新的銷售代表，並且隨著您完成其中一些新員工的招聘，預計下半年會出現拐點？也許您可以評論一下您預計何時僱用這些新員工？

And then as a follow-up, just on R&D. I mean, we appreciate you guys have two very successful commercial franchises, but one piece of feedback we get from investors since tenapanor patents do expire in early 2030s. How are you guys thinking about the pipeline? So where is this on your list of priorities? And how soon can we hear more about that?

然後作為後續行動，就研發而言。我的意思是，我們感謝你們擁有兩個非常成功的商業特許經營權，但我們從投資者那裡得到了一份反饋，因為 Tenapanor 專利確實會在 2030 年代初期到期。大家覺得管道怎麼樣？那麼這在您的優先事項清單中位於何處？我們多久才能聽到更多相關消息？

In terms of sales force expansion, I think with Justin's comments, you heard that we expect that the full expansion will begin having impact by the end of this month. It's a process to hire 60 new people. They don't all come on at once. You need to train and certify. So the full team is not on board until the end of this quarter. So we expect that. And as we've said, we're reiterating our $140 million to $150 million is as you know us well by now that we're not going to get over our skis. We're thrilled with the performance. But I think what you can count on is the reiteration of the guidance that we've given.

在銷售隊伍擴張方面，我認為根據賈斯汀的評論，您聽說我們預計全面擴張將在本月底開始產生影響。這是一個僱用 60 名新員工的過程。它們並不是同時出現的。您需要培訓和認證。因此，整個團隊要到本季末才能加入。所以我們期望如此。正如我們所說，我們重申我們的 1.4 億至 1.5 億美元是你們現在已經很了解的，我們不會超越我們的滑雪板。我們對演出感到非常興奮。但我認為您可以信賴的是我們重申了我們所提供的指導。

In terms of R&D, I think as we've discussed before, one of the reasons that we had brought Mike Kelliher on board as our Executive Vice President of Strategy and Corporate Development was to address exactly the question that you have brought up. He is looking for those programs that we could bring into in-house that are complementary to what we have created with both XPHOZAH and IBSRELA. As we make progress on those things, certainly, that's what we will bring to the floor and share with everyone.

在研發方面，我認為正如我們之前討論過的，我們聘請邁克凱利赫（Mike Kelliher）擔任策略和企業發展執行副總裁的原因之一就是為了準確解決您提出的問題。他正在尋找我們可以引入內部的那些項目，這些項目與我們透過 XPHOZAH 和 IBSRELA 創建的項目相補充。當然，當我們在這些事情上取得進展時，我們將把這些內容帶到會場並與大家分享。

Great, Thank you.

太好了，謝謝。

Laura Chico, Wedbush.

勞拉·奇科，韋德布希。

Good afternoon. Thanks very much for taking the question. I guess just two here. One on IBSRELA. Congrats on the progress. Wondering, could you talk a little bit about what's necessary to see pull forward in earlier lines of utilization? And with respect to your prior peak estimate here, can you remind me how much does earlier utilization play into your assumptions? And then I think I missed it, but XPHOZAH, what was the split on Medicare versus non-Medicare? Thank you.

午安.非常感謝您提出問題。我猜這裡只有兩個。一關於 IBSRELA。祝賀取得的進展。想知道，您能否談談要推動早期利用線的發展需要什麼？關於您先前的峰值估計，您能提醒我早期利用率對您的假設有多大影響嗎？然後我想我錯過了，但 XPHOZAH，醫療保險與非醫療保​​險的差異是什麼？謝謝。

To the latter question first, we didn't provide that split. I think implied in Justin's comments about gross to net, those are things that we're going to see evolving over time. So I think we've talked historically about a 45 to 55 split non-Medicare to Medicare as an example. In terms of IBSRELA, the specificity is to, I think, what you're asking about previous utilization pulling forward is refill prescription and rate of that, we've not talked about that, and I think still it's something that we're looking to understand and not sharing at this stage.

首先對於後一個問題，我們沒有提供這種分割。我認為賈斯汀關於毛淨值的評論中暗示，這些都是我們將看到隨著時間的推移而演變的事情。因此，我認為我們歷史上曾討論過將非醫療保險與醫療保險以 45 比 55 比例分割的例子。就 IBSRELA 而言，我認為您所詢問的關於先前利用率的問題是補充處方和比例，我們還沒有討論過這一點，我認為這仍然是我們正在尋找的東西現階段理解而不是分享。

But it's both, right? It's new patients as well as refills, is physicians that our incredible team on the ground has convinced to try and then that they're expanding their utilization across the broader patient population. It's the grit and the grind that this team does, and that was what drove much of the decision around the expansion that we expect to see the impact of by the end of this month.

但兩者都是，對吧？我們令人難以置信的現場團隊說服了新患者和補充藥物的醫生進行嘗試，然後他們將其利用率擴大到更廣泛的患者群體。正是這個團隊所做的勇氣和磨礪，推動了有關擴展的大部分決定，我們預計在本月底看到擴展的影響。

Thanks very much, guys.

非常感謝，夥計們。

Roanna Ruiz, Leerink Partners.

羅安娜·魯伊斯 (Roanna Ruiz)，Leerink 合夥人。

Hi. Afternoon, everyone. So a question on XPHOZAH. I was curious what current field force strategies are getting the most traction so far with physicians in the first couple of quarters of this year? And if you can elaborate, is volume coming more from possibly new or repeat prescribers so far and how that affects your conviction going into the second half of this year with XPHOZAH?

你好。下午好，大家好。關於 XPHOZAH 的問題。我很好奇，今年前幾季度，目前哪些現場部隊策略最受醫生歡迎？如果您能詳細說明一下，到目前為止，可能新開處方者或重複開處方者的數量是否更多，這如何影響您今年下半年對 XPHOZAH 的信念？

Hi, Roanna. Thanks for your question. So it's kind of tough to think about repeat writers yet. I think is probably not inconsistent with other launches. Physicians are going to be trying drugs in their hardest to treat patients and the fact that you then see expansion within that physician to other patients says it's working in those patients and those patients who may be less challenging or having less of a difficult time managing serum phosphorous deserved, the opportunity to have a product like XPHOZAH helping them manage their phosphorus levels.

嗨，羅安娜。謝謝你的提問。因此，現在還很難考慮重複作家。我認為可能與其他發布並不不一致。醫生將在最困難的情況下嘗試藥物來治療患者，事實上，您隨後會看到該醫生向其他患者擴展，這表明它對這些患者以及那些可能不那麼具有挑戰性或在管理血清方面不太困難的患者起作用磷是值得的，有機會擁有像 XPHOZAH 這樣的產品來幫助他們管理磷水平。

So it's across the board, and that's the enthusiasm that we have that anecdotally, we hear these stories about patients who, for their first time ever, are able to get their serum phosphorous in control. That's meaningful, right? When you've only had binders, your entire career through your training as a nephrologist and then you have a new mechanism like XPHOZAH as an opportunity to help your patients get to goal, you're going to try it. And if it works, as this does, you're going to expand its use.

所以這是全面的，這就是我們的熱情，我們聽到這些關於病人的故事，他們有史以來第一次能夠控制血清磷。這很有意義，對吧？當您只使用黏合劑時，您的整個職業生涯都經過腎臟科醫生的培訓，然後您有了像 XPHOZAH 這樣的新機製作為幫助您的患者實現目標的機會，您就會嘗試它。如果它有效，就像現在這樣，你就會擴大它的用途。

Got it. Makes sense.

知道了。有道理。

Ryan Deschner, Raymond James.

瑞恩‧德施納，雷蒙德‧詹姆斯。

Hi there. First off, congratulations on the impressive quarter. Two quick questions for me. At this point, are you getting any feedback from prescribers suggesting there's uptake in patients with adequately controlled serum phosphorus? And number two, regarding your litigation with CMS, what was the time line for securing access to XPHOZAH for Medicare patients look like in sort of the best-case scenario here?

你好呀。首先，恭喜這個令人印象深刻的季度。有兩個簡單的問題想問我。此時，您是否從處方者那裡得到任何回饋，顯示血清磷得到充分控制的患者有吸收？第二，關於您與 CMS 的訴訟，在最佳情況下，確保 Medicare 患者獲得 XPHOZAH 的時間是多少？

It's an interesting question because you would think that patients in control deserve the opportunity for something like XPHOZAH too. I can say that not many stories yet that are coming that way as I think the enthusiasm and excitement that we see is don't forget that almost 80% of these patients over time in the 6-month period of time are out of control. So one might say in control today, but historically not, they deserve the opportunity as well.

這是一個有趣的問題，因為您可能會認為處於控制狀態的患者也應該有機會接受 XPHOZAH 之類的治療。我可以說，這樣的故事還不多，因為我認為我們看到的熱情和興奮是不要忘記，隨著時間的推移，在 6 個月的時間裡，這些患者中幾乎 80% 都失去了控制。因此，人們可能會說今天處於控制之中，但從歷史上看來並非如此，他們也應該得到這個機會。

So I think it's all over different kinds of profiles. So the most important thing what we're hearing is very strong results in terms of patients getting to goal. I think from the comments that we made, it's premature for us to be providing any commentary in terms of where the status of the lawsuit stands. We are committed, as we learn more in terms of the time line and discussions that we will have with the government lawyers that we will share that.

所以我認為這取決於不同類型的配置。因此，我們聽到的最重要的事情是患者實現目標方面取得了非常強勁的結果。我認為從我們發表的評論來看，我們現在就訴訟的狀況發表任何評論還為時過早。我們承諾，隨著我們從時間表和與政府律師的討論中了解更多信息，我們將分享這一點。

Thank you very much.

非常感謝。

Joseph Thome, TD Cowen.

約瑟夫·托姆，TD·考恩。

Hi there. Good morning. And thank you for taking my questions. Congrats on the quarter. Maybe just two for me to follow on a little bit on a prior question. Can you talk a little bit about the breadth of prescribers that you're seeing for XPHOZAH versus maybe your overall target prescriber account base?

你好呀。早安.感謝您回答我的問題。恭喜本季。也許只有兩個讓我繼續回答之前的問題。您能否談談您在 XPHOZAH 上看到的處方者的廣度以及您的整體目標處方者帳戶基礎？

And then second, just to get a little bit of understanding, I guess, if the bundle does go through and we don't really hear by the end of the year that, that will be extended, I guess, what sort of happens to Medicare patients that are currently on XPHOZAH? Is there a grace period? Or does that hit January 1 and we have to figure out how to get medicine to patients or not?

第二，我想，只是為了獲得一點理解，如果捆綁包確實通過了，而到今年年底我們還沒有真正聽到，那將會延長，我想，會發生什麼目前正在接受 XPHOZAH 的 Medicare 患者？有寬限期嗎？或者到了 1 月 1 日，我們是否必須弄清楚如何向患者提供藥物？

Sure, thanks for the question, Joe. So in terms of the breadth of prescribing, again, we're two quarters into this launch, and we've got an incredible field force of 60 ABDs, making those calls. What I can say is the interest on the part of all those physicians that we have been able to see clearly is demonstrated by the revenue that we announced today. So I think we continue on the path that shows that these patients truly deserve the access that we're fighting for for them.

當然，謝謝你的提問，喬。因此，就處方的廣度而言，我們的此次發布已經進行了兩個季度，我們擁有一支由 60 名 ABD 組成的令人難以置信的現場隊伍，負責做出這些決定。我能說的是，我們今天宣布的收入證明了我們能夠清楚地看到所有醫生的興趣。因此，我認為我們繼續走這條道路，表明這些患者確實值得我們為他們爭取的機會。

To your question about Medicare, if things move forward, we have an important continuity of care program that exists for patients. So that is going to be something that if we need to, patients are going to be able to access. Our hope is, honestly, with everything we're doing and our continued evaluation of other things that we might do is that we don't come to a place where patients who deserve access to a drug like this are prevented to do so because of a misunderstanding or unlawful perspective that CMS has about what we're trying to fight against because they're just going to ultimately effectively ensure that patients don't get this drug that's working if they continue on the path that they're on.

對於您有關醫療保險的問題，如果事情向前發展，我們將為患者提供重要的連續性護理計劃。因此，如果我們需要的話，患者將能夠獲得這些資訊。老實說，我們希望，透過我們正在做的一切以及我們對我們可能做的其他事情的持續評估，我們不會走到這樣的境地：應該獲得此類藥物的患者不會因為以下原因而被阻止這樣做： CMS 對我們試圖反對的事情有誤解或非法觀點，因為他們最終會有效地確保病人如果繼續走自己的路，就不會得到這種有效的藥物。

All right. Thank you.

好的。謝謝。

Thank you.

謝謝。

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Please go ahead. Hi. Thanks for taking my questions. And let me add my congrats on a truly remarkable quarter of growth here. First question is on XPHOZAH, 145% quarterly growth sequential and already surpassing IBSRELA in the second full quarter. I wanted to ask about what's driving that. Obviously, you've mentioned inherent strong demand and the focus on difficult-to-treat patients. But I wanted to ask if there's other areas that you've discussed with physicians that could share a little bit more light on this. And if there has been any discussion of where XPHOZAH may not be appropriate for any of their patients? And then I have a couple of follow-ups.

請繼續。你好。感謝您回答我的問題。讓我對這裡真正令人矚目的季度成長表示祝賀。第一個問題是 XPHOZAH，季度環比增長 145%，並且在第二個完整季度已經超過 IBSRELA。我想問一下是什麼推動了這一點。顯然，您提到了固有的強勁需求以及對難治患者的關注。但我想問您與醫生討論過的其他領域是否可以就此分享更多資訊。有沒有關於 XPHOZAH 可能不適合其患者的討論？然後我有一些後續行動。

Sure. So remember that we started educating the nephrology community about this new mechanism and opportunity to XPHOZAH as disease awareness before what was supposed to be the approval in 2021. we had the terrible surprise that was given to us by the FDA and resulted in the CRL. So there was a lot of disease awareness, product awareness before that occurred.

當然。因此，請記住，在預計於2021 年獲得批准之前，我們就開始向腎病學界宣傳XPHOZAH 的這種新機制和機會，以提高疾病意識。 。因此，在此之前就有了許多疾病意識和產品意識。

And hence, the fight that we started that everyone's aware of through the FDR process two years plus later with this launch. So disease awareness exposed awareness was significant. That certainly plays a role, Ed. But most importantly is the clear unmet need, the requirements that have to be there for patients to get to goal and the fact that this drug is helping accomplish just that.

因此，我們在兩年多後的羅斯福進程中發起了一場大家都知道的鬥爭。因此，疾病意識暴露意識非常重要。這確實發揮了作用，埃德。但最重要的是明顯未滿足的需求，患者實現目標必須滿足的要求，以及該藥物正在幫助實現這一目標的事實。

That's a big massive part of what is the established sort of market for the opportunity. but it's also the field force. We have a group of remarkable ABDs on XPHOZAH side as we do with IBSRELA who are doing the work required to help physicians understand an option for both of these indications where there hasn't been another mechanism with a kind of clinical benefit that both of these drugs are providing. And I think that's what's driving and is driving as it should, what you're seeing in this quarter's performance.

這是已建立的機會市場的很大一部分。但它也是現場力量。我們在XPHOZAH 方面有一群出色的ABD，就像我們在IBSRELA 所做的那樣，他們正在做所需的工作，幫助醫生了解這兩種適應症的選擇，而沒有另一種機制具有這兩種適應症的臨床益處。我認為這就是推動力，而且應該是推動力，你在本季的業績中看到的就是這一點。

In terms of places where you wouldn't use it, there really aren't any comments that we're hearing from that. Remember, our label is for those patients where there is an insufficient response or intolerability to binders, which with the statistics as we all know, insufficient is a very large majority of these patients over any six-month period of time or less, they are patients who can access this product. So I think our label, clinical benefit, the evidence of physicians are seeing in their own practices as well as the commercial approach that we're taking, I think, is resulting in what you see.

至於你不會使用它的地方，我們確實沒有聽到任何評論。請記住，我們的標籤是針對那些對黏合劑反應不足或不耐受的患者，根據眾所周知的統計數據，這些患者中的絕大多數在任何六個月或更短的時間內都表現不足，他們是可以使用該產品的患者。所以我認為我們的標籤、臨床效益、醫生在他們自己的實踐中看到的證據以及我們正在採取的商業方法，我認為，正在導致你所看到的結果。

Great. Are you aware of any physicians experimenting with this drug as a monotherapy?

偉大的。您是否知道有醫生正在嘗試使用這種藥物作為單一療法？

Well, remember that the label says insufficient or inadequate and how they then use that, whether it is on top of a fixed dose of binder, whether it is a decrease in binder dose with XPHOZAH on top of that or an elimination of binder because it's not working and XPHOZAH as monotherapy is all within the indication on our label, and all of those are approaches that physicians are taking.

好吧，請記住標籤上寫著不足或不充分，以及他們如何使用它，是否是在固定劑量的黏合劑之上，是否是在上面使用XPHOZAH 減少黏合劑劑量，還是消除黏合劑，因為它是不起作用，而 XPHOZAH 作為單一療法都在我們標籤上的適應症範圍內，所有這些都是醫生正在採取的方法。

Okay. And last question is just wondering if you could explain a little bit further some of your contingency plans if it comes to pass that your efforts with CMS on the oral phosphate agents are unsuccessful and they're moved into the bundle.

好的。最後一個問題只是想知道，如果您的 CMS 在口服磷酸鹽製劑方面的努力不成功並且它們被移入捆綁包中，您是否可以進一步解釋一下您的一些應急計劃。

Yes. I appreciate the question, absolutely, and would love to be able to be in a position to provide you clarity on that. It's premature at this stage. It's the work that's ongoing. I think the progress that we've made, I feel very, very good about. But you know us well by now that we're not going to get over our skis and communicate something that we aren't fully 100% comfortable with. So we believe that there are opportunities, God forbid that what you just described that occurs, but it's premature for us to provide you those details.

是的。我絕對感謝這個問題，並且很樂意向您澄清這一點。現階段還為時過早。這項工作正在進行中。我認為我們所取得的進展讓我感覺非常非常好。但你現在已經很了解我們了，我們不會放棄我們的滑雪板並傳達一些我們不完全 100% 舒服的東西。因此，我們相信有機會，上帝禁止您剛才描述的情況發生，但我們向您提供這些細節還為時過早。

Thank you, that's helpful.

謝謝，這很有幫助。

Thanks, Ed.

謝謝，艾德。

Matt Kaplan, Ladenburg Thalmann.

馬特卡普蘭，拉登堡塔爾曼。

Hey, guys, thanks for taking the questions and congrats on the very strong quarterly results. Just a follow-up to Ed's question a little bit in terms of XPHOZAH. Maybe it's with the understanding it's early in the launch. But help us understand in terms of the breakdown of patients on the drug? Is it mostly being used in the combination setting? Or to Ed's question, monotherapy in patients who are intolerant of the binders.

嘿，夥計們，感謝您提出問題，並祝賀我們取得了非常強勁的季度業績。只是在 XPHOZAH 方面對 Ed 的問題進行了一些跟進。也許是因為在發布初期就有這樣的理解。但可以幫助我們了解患者對藥物的細分嗎？主要用於組合設定嗎？或回答艾德的問題，對不耐受黏合劑的患者進行單一療法。

So it's a specific breakdown across those patients, right? You go in at anecdotes. When a prescription is filled for XPHOZAH, it doesn't say on top of binder, on top of half binder or monotherapy. You just get prescription for XPHOZAH. So all I can say is, anecdotally, it's a distribution of all those patients. What that then results in what it looks like for all the patients. I can't tell you that.

所以這是對這些患者的具體分類，對吧？你進去聽軼事。當處方 XPHOZAH 時，它沒有說在黏合劑之上、在半黏合劑之上或單一療法。您只需獲得 XPHOZAH 處方即可。所以我只能說，有趣的是，這是所有這些患者的分佈。這就會導致所有患者的情況是什麼樣的。我不能告訴你這一點。

Fair enough. And then any update that you're hearing we spoke recently, but in terms of the status of the Kidney Care Act and where that is?

很公平。然後，您聽到我們最近談到的任何更新，但就《腎臟護理法案》的現狀而言，它在哪裡？

Yeah. I mean, we continue to make incredible progress. If you follow it as we do, Tunico sponsors have joined on the House side. And the fact that we have, as I said in my opening comments, both bipartisan-bicameral support with the Senate companion bill is incredibly strong for us, and it's going to ultimately come down to how bills are passed, which we all know end up being on the bus or many buses at the end of the year when others healthcare legislation that it can ride on.

是的。我的意思是，我們繼續取得令人難以置信的進步。如果你像我們一樣關注的話，Tunico 的贊助商已經加入了眾議院。事實上，正如我在開場白中所說，兩黨兩院對參議院配套法案的支持對我們來說非常強大，這最終將取決於法案如何通過，我們都知道最終會怎樣年底時，當其他醫療保健法規規定可以搭乘公車時，您可以搭乘公車或許多公車。

All of those things that we talked about in the past, what is clear is all of the constituents that have worked on this and continue to work on it are demonstrating why this is absolutely the right thing for Congress to do. While in parallel, we continue all of the other approaches from both the legal side as well as the evaluations that we're undertaking to look at what else we can do after the decision that we made to not file for TDAPA. So I think as you've heard me describe in our last discussion on this in July, it's kind of like a three-dimensional chess game where we're looking at moving all these pieces and trying to make sure that we are doing all possible to ensure access for patients.

我們過去討論過的所有這些事情，顯而易見的是，所有為此工作並繼續努力的選民都在證明為什麼這絕對是國會要做的正確的事情。同時，我們繼續從法律方面以及我們正在進行的評估方面採取所有其他方法，以了解在我們決定不提交 TDAPA 後我們還能做些什麼。因此，我認為正如您在 7 月的最後一次討論中聽到我所描述的那樣，這有點像三維國際象棋遊戲，我們正在考慮移動所有這些棋子並試圖確保我們正在盡一切可能以確保患者就醫。

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

謝謝。我們的問答環節到此結束。現在我想將會議轉回總裁兼執行長 Mike Raab 發表閉幕詞。

Thank you, everyone, for joining us this evening. As I'm sure you understand, we will remain focused on our priorities, and we will provide information updates when we can. In the meantime, we remain steadfast in our commitment to patients and to maintaining our commercial momentum. With that, we can close the call. Operator?

謝謝大家今晚加入我們。我相信您明白，我們將繼續專注於我們的優先事項，並且我們將盡可能提供資訊更新。同時，我們仍然堅定地致力於對患者的承諾並保持我們的商業勢頭。這樣，我們就可以結束通話了。操作員？

Thank you, sir. This concludes today's conference call. Thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful evening.

謝謝您，先生。今天的電話會議到此結束。感謝大家參加今天的演講。您現在可以斷開線路並度過一個美好的夜晚。