Renalytix PLC (RNLX) 2023 Q3 法說會逐字稿

Good morning, and welcome to the Renalytix conference call to review third-quarter fiscal year 2023 financial results. (Operator Instructions) And as a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DeNardo of CapComm Partners, for a few introductory comments. Sir, please go ahead.

早上好，歡迎參加 Renalytix 電話會議，回顧 2023 財年第三季度財務業績。 （操作員說明）謹此提醒，本次通話將被錄音以供重播之用。現在我想將電話轉給 CapComm Partners 的 Peter DeNardo，請其發表一些介紹性意見。先生，請繼續。

Thank you, Chris. Thank you all for participating in today's call. Joining me today from Renalytix to provide formal remarks are James McCullough, Chief Executive Officer; Tom McLain, President; and James Sterling, Chief Financial Officer. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

謝謝你，克里斯。感謝大家參加今天的電話會議。今天，Renalytix 首席執行官 James McCullough 與我一起發表正式講話；湯姆·麥克萊恩，總裁；和首席財務官詹姆斯·斯特林。在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括 1995 年《私人證券訴訟改革法案》含義內的前瞻性聲明。

Any statements made during this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. Examples of these statements include, without limitation, the potential benefits, including economic savings of KidneyIntelX with potential for KidneyIntelX to receive regulatory clearance from the FDA, the commercial prospects of KidneyIntelX, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, our expectations regarding reimbursement decisions, and the ability of KidneyIntelX to curtail cost of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes, trends in our market and potential benefits of government policy change, the impact of COVID-19 and other world events on our business, our expectations for hiring, product development, strategic partnerships and collaborations, reimbursement decisions, clinical studies and regulatory submissions, our business strategies and future growth including plans, expectations, and opportunities for financing our operations, and revenue projections and guidance.

本次電話會議期間做出的任何與未來事件、結果或業績的預期或預測相關的聲明均為前瞻性聲明。這些陳述的例子包括但不限於潛在的好處，包括 KidneyIntelX 的經濟節省以及 KidneyIntelX 獲得 FDA 監管許可的潛力、KidneyIntelX 的商業前景，包括 KidneyIntelX 是否會成功地被醫生採用並分銷和銷售，我們對報銷決定的期望，以及 KidneyIntelX 削減慢性和終末期腎病成本、優化護理服務和改善患者結果的能力、我們市場的趨勢以及政府政策變化的潛在好處、COVID-19 的影響和關於我們業務的其他世界事件、我們對招聘、產品開發、戰略夥伴關係和合作的期望、報銷決定、臨床研究和監管提交、我們的業務戰略和未來增長，包括計劃、期望和運營融資機會以及收入預測和指導。

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Annual Report on Form 20-F that was filed on October 31, 2022, with the Securities and Exchange Commission.

這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。有關與我們業務相關的風險和不確定性的描述，請參閱我們於 2022 年 10 月 31 日向美國證券交易委員會提交的 20-F 表格年度報告中的風險因素部分。

All forward-looking statements made on this call are based on management's current estimates and various assumptions. Renalytix disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, June 9, 2023. I'll now turn the call over to James McCullough. James?

本次電話會議中所做的所有前瞻性陳述均基於管理層當前的估計和各種假設。除法律要求外，Renalytix 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，無論是由於新信息、未來事件還是其他原因。本次電話會議包含時間敏感信息，僅截至今天（2023 年 6 月 9 日）直播時準確。我現在將電話轉給 James McCullough。詹姆士？

Thank you, Peter, and good morning. As we close our fiscal year 2023, we are approaching what will be a simple and powerful message to primary care providers across the country for our lead product, KidneyIntelX. One, we accept all insurance; two, patient outcomes improve when you use it; and three, as anticipated, KidneyIntelX is FDA approved.

謝謝你，彼得，早上好。在 2023 財年結束之際，我們正在向全國各地的初級保健提供者傳達我們的主導產品 KidneyIntelX 的簡單而有力的信息。一、我們接受一切保險；第二，使用它時患者的治療效果會得到改善；第三，正如預期的那樣，KidneyIntelX 已獲得 FDA 批准。

Completing these three pillars would assure KidneyIntelX will be accessible across all of primary care. And we'll have achieved a distinct product proposition in a largely untapped market that could benefit millions of Americans with diabetes and kidney disease. And in anticipation of securing this diagnostic trifecta, we are moving to advance the KidneyIntelX commercial footprint to win adoption across large groups of primary care providers who are helping patients with diabetes and kidney disease.

完成這三個支柱將確保 KidneyIntelX 將在所有初級保健中可用。我們將在一個很大程度上尚未開發的市場中實現獨特的產品主張，使數百萬患有糖尿病和腎病的美國人受益。為了實現這一診斷三連勝，我們正在努力推進 KidneyIntelX 的商業足跡，以贏得幫助糖尿病和腎病患者的大量初級保健提供者的採用。

Our expanding real-world evidence proves these patients can get better and more equal access to the care they need through the health care systems, in independent practice offices, and through government institutions. KidneyIntelX is a unique medical device that combines blood-based biomarkers with key features in the patient's electronic medical record, all processed by an artificial intelligence-enabled multimodal algorithm. Our goal has been to create a safe and clinically validated artificial intelligence-enabled prognostic test results that can be easily used by a primary care provider to better understand the patient's risk of developing kidney failure at a very early stage. This is important because it is at the early stages when therapy, specialist involvement, and behavior modifications can have the greatest effect to keep people healthy and productive.

我們不斷擴大的現實世界證據證明，這些患者可以通過醫療保健系統、獨立診所和政府機構獲得更好、更平等的所需護理。 KidneyIntelX 是一種獨特的醫療設備，它將基於血液的生物標記物與患者電子病歷中的關鍵特徵相結合，所有這些特徵均由人工智能支持的多模式算法進行處理。我們的目標是創建安全且經過臨床驗證的人工智能預後測試結果，初級保健提供者可以輕鬆使用該結果，以更好地了解患者在早期階段發生腎衰竭的風險。這很重要，因為在早期階段，治療、專家參與和行為改變可以對保持人們的健康和生產力產生最大的效果。

We believe KidneyIntelX's Exhibit A as to how artificial intelligence using clinical and biological data can be harnessed in a clinical product capable of being regulated by FDA, reimbursed by insurance, including Medicare and subject to rigorous real-world evidence validation. KidneyIntelX also provides us with the blueprint for future product development that uses important biomarkers, electronic data features, and powerful algorithms to create the best-performing, safest and ethically responsible medical devices. With broad insurance reimbursement, definitive outcomes data, and an FDA regulatory pathway insight, our commercial strategy is clear.

我們相信 KidneyIntelX 的證據 A，即如何在能夠受 FDA 監管、由包括 Medicare 在內的保險報銷並接受嚴格的現實世界證據驗證的臨床產品中利用使用臨床和生物數據的人工智能。 KidneyIntelX 還為我們提供了未來產品開發的藍圖，該藍圖使用重要的生物標誌物、電子數據功能和強大的算法來創建性能最佳、最安全且對道德負責的醫療設備。憑藉廣泛的保險報銷、明確的結果數據以及 FDA 監管途徑的洞察力，我們的商業策略是明確的。

We are focusing on regions of the United States where there are large populations of individuals with diabetes and kidney disease and where insurance reimbursement for KidneyIntelX is fast approaching a super majority status. Our regional focus for the remainder of calendar 2023 is in Illinois, New York, North Carolina, and South Carolina, Texas, and Florida. As of this quarter in Chicago, Illinois and the New York Metro area, our estimated insurance payment for KidneyIntelX from a combination of groups like Medicare, Medicaid, and private payers have already exceeded 90% of the KidneyIntelX eligible testing population. During the third quarter, we secured insurance coverage with EmblemHealth, covering over 3 million lives in New York and Connecticut, and more recently with CareFirst BlueCross BlueShield, which is the largest health care plan in the US mid-Atlantic region.

我們重點關注美國有大量糖尿病和腎病患者的地區，這些地區的 KidneyIntelX 保險報銷正在迅速接近絕大多數狀態。 2023 年剩餘時間裡，我們的區域重點是伊利諾伊州、紐約州、北卡羅來納州、南卡羅來納州、德克薩斯州和佛羅里達州。截至本季度，在芝加哥、伊利諾伊州和紐約都會區，我們估計 Medicare、Medicaid 和私人付款人等團體為 KidneyIntelX 支付的保險費用已經超過了 KidneyIntelX 合格測試人群的 90%。在第三季度，我們通過安保健康保險獲得了保險，覆蓋了紐約和康涅狄格州超過 300 萬人的生命，最近又通過 CareFirst BlueCross BlueShield 獲得了保險，這是美國大西洋中部地區最大的醫療保健計劃。

In total, CareFirst serves 3.4 million members in Maryland, Washington, D.C., in Northern Virginia as well as the federal employee program, FEP, administered by CareFirst. This agreement complements Blue Cross Blue Shield contracts already secured with Wellmark Blue Cross Blue Shield in Iowa, South Dakota, with an estimated 2 million covered lives. And Blue Cross Blue Shield of Illinois, with an estimated 8 million covered lives. Our recent coverage contract wins with leading insurance groups are reinforcing our approach to developing strong data evidence defining the health economic consequences of uncontrolled kidney disease and validating KidneyIntelX in real-world use. We expect this momentum with insurance contracts to accelerate with an anticipated successful conclusion with FDA.

CareFirst 總共為馬里蘭州、華盛頓特區、北弗吉尼亞州的 340 萬名會員以及由 CareFirst 管理的聯邦僱員計劃 FEP 提供服務。該協議是對已與南達科他州愛荷華州 Wellmark Blue Cross Blue Shield 簽訂的 Blue Cross Blue Shield 合同的補充，估計覆蓋了 200 萬人的生命。伊利諾伊州的 Blue Cross Blue Shield 估計覆蓋了 800 萬人的生命。我們最近與領先的保險集團簽訂的承保合同加強了我們開發強有力的數據證據的方法，這些數據證據定義了不受控制的腎臟疾病的健康經濟後果，並驗證了 KidneyIntelX 在現實世界中的使用。我們預計，隨著與 FDA 的成功締結，保險合同的這一勢頭將加速。

To expand our commercial footprint, we announced in May, the selection of EVERSANA, a global leader in life science commercialization services. EVERSANA will launch its field deployment and training solutions with Renalytix to cost effectively build awareness across key parts of the United States, beginning this summer. This EVERSANA-Renalytix model is expected to accelerate the adoption of KidneyIntelX. Our President, Tom McLain, will discuss this in more detail shortly.

為了擴大我們的商業足跡，我們於 5 月宣布選擇生命科學商業化服務的全球領導者 EVERSANA。從今年夏天開始，EVERSANA 將與 Renalytix 一起推出其現場部署和培訓解決方案，以經濟有效地在美國主要地區建立意識。該 EVERSANA-Renalytix 模型預計將加速 KidneyIntelX 的採用。我們的總統湯姆·麥克萊恩將很快對此進行更詳細的討論。

As we signaled last quarter, we completed the milestone of transitioning to long-term commercial insurance payments for patients tested at the Mount Sinai Health System. During this transition, there was a short-term adverse impact on testing volumes. Importantly, Mount Sinai has this month issued a population health update to all physicians to include the KidneyIntelX testing in the diabetes kidney disease care pathway, based on their newly published KidneyIntelX utility evidence. We expect additional health systems will likely do the same given the important positive results from the growing body of positive real-world evidence.

正如我們上季度所表示的那樣，我們完成了向西奈山衛生系統接受檢測的患者過渡到長期商業保險付款的里程碑。在此過渡期間，測試量受到了短期不利影響。重要的是，西奈山本月向所有醫生髮布了人口健康更新，根據他們新發布的 KidneyIntelX 實用證據，將 KidneyIntelX 測試納入糖尿病腎病護理途徑。鑑於越來越多的現實世界積極證據所取得的重要積極成果，我們預計其他衛生系統也可能會採取同樣的做法。

Two recent studies presented at the National Kidney Foundation Spring Clinical Conference illustrate the following: First, Atrium Health System demonstrated KidneyIntelX testing accurately assesses the higher risk for progression of chronic kidney disease in black patients versus other races. This is an important precursor in addressing healthcare access inequalities within this patient population. Notably, within Atrium, a KidneyIntelX test result led to increased prescription of SGLT2 inhibitor drug therapy to provide improved care for black patients.

最近在國家腎臟基金會春季臨床會議上發表的兩項研究說明了以下內容：首先，Atrium Health System 證明 KidneyIntelX 測試可以準確評估黑人患者與其他種族患者相比，慢性腎病進展的風險更高。這是解決該患者群體中醫療保健獲取不平等問題的重要先兆。值得注意的是，在 Atrium 內，KidneyIntelX 測試結果導致增加了 SGLT2 抑製劑藥物治療的處方，以改善對黑人患者的護理。

Second, researchers from the University of Illinois, Chicago, and the University of Utah presented a contemporary analysis of type 2 diabetes and kidney disease in the Veterans Health Administration population. The higher incidences and poor outcomes in the veteran population versus the US population at large, demonstrated the need for risk assessment in early-stage kidney disease is recommended by the VA's care directive titled Chronic Kidney Disease Prevention, Early Recognition and Management.

其次，來自芝加哥伊利諾伊大學和猶他大學的研究人員對退伍軍人健康管理局人群中 2 型糖尿病和腎臟疾病進行了當代分析。與美國整體人口相比，退伍軍人群體的發病率較高且結果較差，這表明退伍軍人管理局題為“慢性腎髒病預防、早期識別和管理”的護理指令建議對早期腎臟疾病進行風險評估。

Please look for significant new real-world evidence data to be released at the American Diabetes Association 83rd scientific sessions from June 23 to June 26 this month. I will now turn over to Tom McLain, our President, to discuss additional aspects of our commercial progress. Tom?

請關注本月 6 月 23 日至 26 日美國糖尿病協會第 83 屆科學會議上發布的重要的新現實證據數據。我現在將請我們的總裁湯姆·麥克萊恩討論我們商業進展的其他方面。湯姆？

Thank you, James. With anticipated FDA approval for KidneyIntelX, we're in preparation for a focused expansion of our commercialization of KidneyIntelX in the US. The New York City metro area continues to be the most significant market opportunity for Renalytix.

謝謝你，詹姆斯。隨著 KidneyIntelX 預計獲得 FDA 批准，我們正在準備重點擴大 KidneyIntelX 在美國的商業化。紐約都會區仍然是 Renalytix 最重要的市場機會。

Having demonstrated the clinical benefits of KidneyIntelX testing in the real-world evidence study at Mount Sinai, we've completed the conversion of test payment to commercial payers. Building on that success, we've initiated expansion into large clinical practice groups in the New York metro area. They provide many of the same benefits of launching KidneyIntelX into a health system with the added opportunities to accelerate timelines and to engage payers to support the program. We also expect to add additional health system partnerships in the New York Metro area during fiscal year 2024.

在西奈山的現實世界證據研究中證明了 KidneyIntelX 測試的臨床益處後，我們已經完成了測試付款向商業付款人的轉換。在此成功的基礎上，我們開始向紐約都會區的大型臨床實踐團隊擴張。它們提供了與將 KidneyIntelX 引入醫療系統相同的許多好處，並增加了加快時間表和吸引付款人支持該計劃的機會。我們還預計在 2024 財年期間在紐約都會區增加更多的衛生系統合作夥伴關係。

A second area of focus for expanded commercialization is in the Advocate Health regions, including the Carolinas, Georgia, Illinois, and Wisconsin. Last December, Atrium Health merged with Advocate Aurora Health to form Advocate Health. The combined health system serves nearly 6 million patients annually. And it's the fifth largest non-profit integrated health system in the nation. Our real-world evidence study with Atrium Wake Forest has produced utility evidence that can expand commercial testing in the southeastern US, focused on a combination of Atrium Health locations, large practice groups and other health systems.

擴大商業化的第二個重點領域是 Advocate Health 地區，包括卡羅來納州、佐治亞州、伊利諾伊州和威斯康星州。去年 12 月，Atrium Health 與 Advocate Aurora Health 合併，成立 Advocate Health。聯合醫療系統每年為近 600 萬患者提供服務。它是全國第五大非營利綜合衛生系統。我們與 Atrium Wake Forest 進行的真實世界證據研究已經產生了實用證據，可以擴大美國東南部的商業測試，重點關注 Atrium Health 地點、大型實踐團體和其他衛生系統的組合。

In addition, with the benefit of Blue Cross Blue Shield, Illinois coverage, we are generating initial test demand in large practice groups and hospitals in the Metro Chicago area. Third, over the past 12 months, we have developed sales, e-marketing, and clinical intelligence on what can drive successful expansion in the primary care office in new markets. We will apply that knowledge in partnership with EVERSANA in Texas and Florida, beginning this summer. These states represent significant opportunities in terms of number of eligible patients and access to the primary care practice.

此外，借助伊利諾伊州 Blue Cross Blue Shield 的覆蓋範圍，我們正在芝加哥大都會地區的大型診所和醫院產生初步測試需求。第三，在過去 12 個月中，我們開發了銷售、電子營銷和臨床情報，以推動初級保健辦公室在新市場的成功擴張。從今年夏天開始，我們將與德克薩斯州和佛羅里達州的 EVERSANA 合作應用這些知識。這些州在合格患者數量和獲得初級保健實踐方面代表著巨大的機會。

EVERSANA will support the hiring and employee of 100% dedicated sales reps in those markets, and they will also help us improve sales force effectiveness through a comprehensive program combining our KidneyIntelX sales training materials, along with their disease state and sales effectiveness programs. Our agreement with EVERSANA provides that these salespeople can transition over to become Renalytix employees. I look forward to updating you on our advances during future earnings calls. I'd now like to turn the call over to James Sterling, who will discuss our financial results for the quarter. James?

EVERSANA 將支持在這些市場招聘和僱用 100% 專職銷售代表，他們還將通過結合我們的 KidneyIntelX 銷售培訓材料及其疾病狀態和銷售效率計劃的綜合計劃來幫助我們提高銷售隊伍的效率。我們與 EVERSANA 的協議規定，這些銷售人員可以轉型成為 Renalytix 員工。我期待在未來的財報電話會議上向您通報我們的進展情況。我現在想將電話轉給詹姆斯·斯特林，他將討論我們本季度的財務業績。詹姆士？

Thanks, Tom. Today, we issued our quarterly SEC filing under US GAAP that includes 3- and 9-month financial results for the periods ending March 31, 2023, which corresponds to our third quarter of the fiscal year. Figures I will discuss here are based on our GAAP financials and quoted in US dollars, which is our reporting currency.

謝謝，湯姆。今天，我們根據美國公認會計準則向 SEC 提交了季度報告，其中包括截至 2023 年 3 月 31 日（相當於我們本財年第三季度）的 3 個月和 9 個月的財務業績。我將在這裡討論的數字基於我們的公認會計原則財務數據，並以美元報價，美元是我們的報告貨幣。

For the quarter, we recorded revenue of $724,000 compared to $812,000 reported for the third quarter of the prior fiscal year. As James noted earlier, and which we highlighted in last quarter's call, our revenue in the quarter was impacted by the transition to commercial payment for testing at Mount Sinai. Order mechanisms are now restored, and testing has resumed at the hospital system there.

本季度我們的收入為 724,000 美元，而上一財年第三季度的收入為 812,000 美元。正如詹姆斯早些時候指出的那樣，我們在上個季度的電話會議中強調了這一點，我們本季度的收入受到西奈山測試向商業付款過渡的影響。秩序機制現已恢復，醫院系統也已恢復測試。

Operating expenses were $11 million on a GAAP basis, reduced from $14.7 million in the prior year period. This reflects the result of actions we took over the last year to lower operating expenses through program, vendor, and employee reductions, and an ongoing focus on maintaining cost controls prior to testing volumes and revenue ramping. Net loss for the third quarter of fiscal 2023 was $12.1 million or $0.14 per share. This was down from $14.7 million or $0.20 per share for the third quarter of fiscal 2022. We ended the quarter with $33 million in cash as of March 31, 2023. Operator, we can now open the call for questions.

按 GAAP 計算，運營費用為 1,100 萬美元，較上年同期的 1,470 萬美元有所減少。這反映了我們去年通過減少計劃、減少供應商和員工來降低運營費用，以及在測試數量和收入增長之前持續關注維持成本控制的結果。 2023 財年第三季度淨虧損為 1210 萬美元，即每股 0.14 美元。這比 2022 財年第三季度的 1470 萬美元或每股 0.20 美元有所下降。截至 2023 年 3 月 31 日，我們的季度末現金為 3300 萬美元。操作員，我們現在可以開始提問。

(Operator Instructions) Dan Arias, Stifel.

（操作員說明）Dan Arias，Stifel。

Good morning, guys. Thanks for the questions here. Tom or James, to Tom's point on the importance of the New York metro area, can you just maybe talk about the ramp path forward for usage at this point and the headwinds that may or may not exist?

早上好傢伙。感謝您在這裡提出的問題。湯姆或詹姆斯，對於湯姆關於紐約都市區重要性的觀點，您能否談談目前使用的坡道路徑以及可能存在或不存在的不利因素？

And, obviously, it's been a long and winding road here, at least as it relates to the New York City area. So, to what extent do you feel like you're past the various issues you've encountered when it comes to just the way that things work at institutions like Mount Sinai? And how do we think about heading into 2024, the successive volume increases that we could expect perhaps?

顯然，這是一條漫長而曲折的道路，至少與紐約市地區有關。那麼，當涉及到西奈山等機構的運作方式時，您在多大程度上感覺自己已經克服了所遇到的各種問題？我們如何看待進入 2024 年，我們可能預期的銷量連續增長？

Thanks, Dan. I'll let Tom answer most of this. I think it has been a long winding road. And we have learned an enormous amount about the complexities of introducing a new technology in the primary care.

謝謝，丹。我會讓湯姆回答大部分問題。我認為這是一條漫長而曲折的道路。我們已經充分了解在初級保健中引入新技術的複雜性。

The advantage of working closely with Mount Sinai is we're able to get in and really understand all of the intricacies associated with integrating and deploying an advanced prognostic throughout the medical system, the electronic medical record system, understanding all the behavioral issues associated with physician ordering, interpretation, and action. And it has been quite complex.

與西奈山密切合作的優勢在於，我們能夠深入了解並真正了解在整個醫療系統、電子病歷系統中集成和部署先進預後相關的所有復雜問題，了解與醫生相關的所有行為問題順序、解釋和行動。而且情況相當複雜。

The good news is we have a significant amount of know-how, which has been accumulated. And I think we've mentioned this in the past, this is making other deployments that we're doing substantially easier than when we did it the first time in Sinai. So, I think the road is getting clearer. We're obviously humble and cautious about predicting how that road goes.

好消息是我們積累了大量的專業知識。我想我們過去已經提到過這一點，這使得我們正在做的其他部署比我們第一次在西奈半島進行時要容易得多。所以，我認為道路變得越來越清晰。顯然，我們對於預測這條路將如何發展持謙虛和謹慎的態度。

But it's very nice to see the diversity of insurance, coverage coming in. That's a huge validation. It's very nice to see that we've been able to switch to a full commercial pay model. That was a major canyon to get over. And we've now done that.

但很高興看到保險和承保範圍的多樣性的出現。這是一個巨大的驗證。很高興看到我們已經能夠切換到完整的商業付費模式。那是一個需要翻越的大峽谷。我們現在已經做到了。

And the clinical system needed to buy into the commercial transition that was not trivial. And there had to be an awful lot of evidence to show that KidneyIntelX works. It works well. And it is something that could be used by primary care. So, there are a lot of validation points which are coming around us for the future. But Tom, please comment further.

臨床系統需要接受商業轉型，這並非易事。而且必須有大量證據證明 KidneyIntelX 有效。效果很好。這是初級保健可以使用的東西。因此，未來我們周圍有很多驗證點。但是湯姆，請進一步發表評論。

Thanks, James. Just, Dan, building on what James commented on, I want to point out two things that were accomplished in the quarter at Mount Sinai are very significant that we went through an evidence development program with them. But during the third quarter, they agreed to the conversion to a commercial payment model within that system. And that was significant because of how seriously a health system like Mount Sinai takes that.

謝謝，詹姆斯。只是，丹，根據詹姆斯的評論，我想指出西奈山本季度完成的兩件事非常重要，我們與他們一起完成了證據開發計劃。但在第三季度，他們同意在該系統內轉換為商業支付模式。這很重要，因為像西奈山這樣的衛生系統對此非常重視。

And secondly, as James said, to have population health work with clinical medicine to issue that guideline and bulletin update that incorporates KidneyIntelX into their testing. It's very significant. Not only there, but for other health systems.

其次，正如 James 所說，讓人口健康與臨床醫學合作，發布將 KidneyIntelX 納入測試的指南和公告更新。這是非常有意義的。不僅在那裡，其他衛生系統也是如此。

The second point that can often be lost is in the course of amassing the real-world evidence for Mount Sinai because they have a diverse population that also is a diverse payer population. So another power of that study is that we have amassed data on outcome benefits for hundreds of members of the major health plans in the New York City metro area. And we can sit down and talk to them in specifics about their members.

經常會丟失的第二點是在收集西奈山真實世界證據的過程中，因為他們擁有多樣化的人口，同時也是多樣化的付款人。因此，這項研究的另一個優勢是，我們收集了紐約市都市區數百名主要健康計劃成員的結果福利數據。我們可以坐下來與他們詳細討論他們的成員。

And so, as we look to expand into large practice groups and other health systems, having that ability to bring the recommendations from payers who are confident about the benefits of incorporating KidneyIntelX testing into care for their members is also going to be a lot of wind in our sails as we begin to build off those Mount Sinai successes as we go forward. And that is an outcome of the work with Mount Sinai that has broad implications across that whole metro area.

因此，當我們希望擴展到大型實踐團體和其他衛生系統時，能夠從那些對將 KidneyIntelX 測試納入其成員的護理中的好處充滿信心的付款人那裡獲得建議也將是很大的優勢當我們繼續前進時，我們開始在西奈山的成功基礎上繼續前進。這是與西奈山合作的成果，對整個都市區產生了廣泛的影響。

Okay. So if I could just ask a follow-up and sort of combine those two thoughts there. Where is the confidence that in 2024, you will, at least at Mount Sinai, see quarterly progression of volumes that barring some sort of shock to the system or unique circumstance will have people thinking about a natural path upward on KidneyIntelX?

好的。因此，如果我可以詢問後續情況並將這兩種想法結合起來。到 2024 年，至少在西奈山，您將看到銷量的季度增長，除非系統受到某種衝擊或特殊情況，否則人們會考慮 KidneyIntelX 的自然上昇路徑，那麼信心在哪裡？

And then, associated with that, if I could, for O.J., presumably, the next time we're on the phone here will be the end of the calendar year. It sounds like you should have FDA approval. Do you think you'll be able to give an outlook on revenues or if not revenues, volumes for fiscal '24. Just to sort of -- people are trying to inform their models here and think about the ramp. But I'm just wondering what ability we have to do that at this point.

然後，與此相關的是，如果可以的話，對 O.J. 來說，我們下次在這里通電話的時間可能是日曆年年底。聽起來你應該獲得 FDA 的批准。您認為您能夠對 24 財年的收入前景做出預測嗎？只是為了某種程度——人們試圖在這裡告知他們的模型並思考坡道。但我只是想知道我們現在有什麼能力可以做到這一點。

Yeah. Let's see when we get there. We're obviously especially after this market environment, cautious. That doesn't mean that we're cautious operationally. We're moving assertively operationally. But we want to make sure that going forward, we are under-promising and over-delivering. And that we remain in that continuum.

是的。讓我們看看我們什麼時候到達那裡。顯然，我們特別是在這種市場環境之後，持謹慎態度。這並不意味著我們在操作上持謹慎態度。我們正在積極採取行動。但我們希望確保，在未來，我們不會承諾不足，但交付過多。我們仍然處於這個連續體中。

And I think, again, as we emerge, hopefully, in the summer with this trifecta of regulatory, reimbursement, and data, we should be able to grow consistently. And I think what you're going to see is the emergence of growth diversity. And that's important.

我再次認為，當我們在今年夏天憑藉監管、報銷和數據三重奏出現時，我們應該能夠持續增長。我認為你將會看到增長多樣性的出現。這很重要。

So, we're going to start to see testing volume develop in different categories, direct to physician, for example, other health care systems. And that's really the metric for success as opposed to just relying exclusively on Mount Sinai. But O.J.?

因此，我們將開始看到不同類別的檢測量不斷發展，直接針對醫生，例如其他醫療保健系統。這確實是成功的衡量標準，而不是僅僅依賴西奈​​山。但是O.J.？

That's correct. I'd like to see -- we need a bit more time to see some consistent volume development and build to have a basis on which to provide guidance with full confidence. And so, we all recognize the desire, the need to provide some guidance in quarters ahead. I just want to make sure that when we do so, we do so on a strong basis of confidence. And we can see the trends that we'll be consistently building.

這是正確的。我希望看到 - 我們需要更多的時間來看到一些一致的數量開發，並建立一個可以充滿信心地提供指導的基礎。因此，我們都認識到在未來幾個季度提供一些指導的願望和需要。我只是想確保當我們這樣做時，我們是在堅定的信心基礎上這樣做的。我們可以看到我們將持續打造的趨勢。

Okay. Thanks, James.

好的。謝謝，詹姆斯。

Chaitanya Gollakota, H.C. Wainwright.

Chaitanya Gollakota，H.C.溫賴特。

Hey. This is Chait on behalf of Yi Chen. And just following up from the previous question. And I know you've addressed this in your prepared remarks. But could you summarize the key factors required to drive volume growth moving forward and subsequently, test volume as well? Thank you.

嘿。我是 Chait，代表陳亦。繼續上一個問題。我知道你已經在準備好的發言中談到了這個問題。但您能否總結一下推動銷量增長以及隨後測試銷量所需的關鍵因素？謝謝。

So, the trifecta is a great -- it's three legs of the stool. It's outcomes data, diverse reimbursement, and regulatory approval. In this particular market, which is so large, the patients with diabetes and kidney disease in the United States runs well into the 8 figures. And we felt from the beginning, we needed to have an FDA process in order to set a baseline standard for early-stage prognosis. And that was new.

所以，三連勝是一個偉大的——它是凳子的三個腿。它是結果數據、多樣化的報銷和監管部門的批准。在這個如此龐大的市場中，美國的糖尿病和腎病患者已達到8位數。我們從一開始就覺得，我們需要 FDA 流程來為早期預後設定基線標準。那是新的。

So, this is a de novo marketing authorization that we are seeking. It is unique. And so to really drive scaled growth, you need to have all three legs of the stool: regulatory, reimbursement and data. The data looks great. That's the foundation for everything. We're obviously validating reimbursement quite rapidly.

因此，這是我們正在尋求的從頭營銷授權。它是獨一無二的。因此，要真正推動規模化增長，您需要具備所有三條腿：監管、報銷和數據。數據看起來很棒。這是一切的基礎。顯然，我們正在快速驗證報銷。

And most importantly, we're validating reimbursement with depth and diversity. It's not one coverage contract. It is established payment coverage contracts across the universe of payers here, Blue Cross Blue Shield, Medicare, Medicaid, other private insurance groups.

最重要的是，我們正在深度和多樣性地驗證報銷。這不是一份承保合同。它是在所有付款人、藍十字藍盾、醫療保險、醫療補助和其他私人保險團體中建立的支付保險合同。

This is the diversity that you look to establish a long-term pattern of payment. And, of course, Medicare started all off with pricing KidneyIntelX at $950 reportable result. We have not compromised that. That's very important. And then, of course, FDA regulatory.

這就是您希望建立長期支付模式的多樣性。當然，Medicare 一開始就將 KidneyIntelX 的可報告結果定價為 950 美元。我們並沒有在這一點上妥協。這非常重要。當然，還有 FDA 監管。

So once with those three legs in stool, you have substantial barriers to entry. You have a long-term competitive advantage because you've now set a very high bar, especially with the de novo marketing authorization through FDA. Assuming we get there, it's going to be very difficult to turn around and create a validated reimbursed regulated product to compete with KidneyIntelX. And so, that gives us room.

因此，一旦將這三條腿放在凳子上，你就會遇到很大的進入障礙。您擁有長期的競爭優勢，因為您現在設定了非常高的標準，特別是通過 FDA 的從頭營銷授權。假設我們實現了這一目標，那麼扭轉局面並創建經過驗證的可報銷監管產品來與 KidneyIntelX 競爭將非常困難。所以，這給了我們空間。

And back to Dan's question and yours, what we've been doing over the last 18 months is generating real-world experience with KidneyIntelX, in the wild. What happens? How does it happen? What are the objections? What are the support points? All of this goes into defining what has become a very clear, simple message to the primary care physician, which is a majority of our market.

回到 Dan 和您的問題，過去 18 個月我們一直在做的就是利用 KidneyIntelX 在野外生成真實的經驗。會發生什麼？這是怎麼發生的？反對意見是什麼？有哪些支撐點？所有這些都旨在向初級保健醫生（我們的市場主體）傳達一個非常清晰、簡單的信息。

So, we know that greater than 90% of people with diabetes and kidney disease are in early stage, which is terrific. Because in the early stage, you can treat them more effectively before disease develops, before the clock start to spiral. But you need to have a very simple message to primary care.

所以，我們知道超過 90% 的糖尿病和腎病患者都處於早期階段，這真是太棒了。因為在早期階段，您可以在疾病發展之前、在時間開始螺旋式上升之前更有效地治療它們。但您需要向初級保健傳達一個非常簡單的信息。

And of course, the difficulty is getting into the simplicity. And as we said early on in the call, we're now arriving at that tipping point. We accept all insurance. The data looks great, if you use it. It benefits patients. And it's published. And then we hope very shortly to be able to say it's FDA approved.

當然，困難在於變得簡單。正如我們在電話會議早些時候所說的那樣，我們現在已經到達了這個轉折點。我們接受所有保險。如果你使用的話，數據看起來很棒。它有益於患者。並且它已經出版了。然後我們希望很快就能宣布它已獲得 FDA 批准。

So with that trifecta in place, we're now -- when that trifecta becomes in place, we're now anticipating that we're looking at putting in a very strong and direct to commercial program with sales and marketing focused on regions of the country where we have super majority insurance coverage and where there are large populations of patients with diabetes and kidney disease. And we've given the list of where those are.

因此，隨著這三重奏就位，我們現在 - 當這三重奏就位時，我們現在預計我們正在考慮實施一個非常強大且直接的商業計劃，其中銷售和營銷重點關注該地區我們擁有絕大多數保險覆蓋的國家，並且有大量糖尿病和腎病患者。我們已經給出了這些位置的列表。

So, this positions us well in the summer to really start to lean in to drive adoption. But it's rare to have that trifecta in place in such a large effectively wide-open market without a direct competitive threat in the near term. And that should start to generate results. Tom, I don't know if you want to add to that.

因此，這使我們能夠在夏天真正開始努力推動採用。但在如此大的、有效、開放的市場中，在短期內沒有直接競爭威脅的情況下，實現這三重奏是很少見的。這應該開始產生結果。湯姆，我不知道你是否想補充這一點。

I think you covered that very well, James. Primary care is where the majority of these patients are seen today. And the point that we expect to be at very soon with anticipated FDA approval is very simple, straightforward answers that clearly show Renalytix has achieved those three necessary pillars for success. And that really eliminates the barriers that often limit introducing a novel innovative approach like KidneyIntelX into primary care. And we're very excited to be at the point that we are at today.

我認為你講得很好，詹姆斯。如今，大多數患者就診於初級保健機構。我們預計很快就會獲得 FDA 的批准，這是一個非常簡單、直接的答案，清楚地表明 Renalytix 已經實現了成功的三個必要支柱。這確實消除了通常限制將 KidneyIntelX 等新穎創新方法引入初級保健的障礙。我們很高興能走到今天這個地步。

(Operator Instructions) Mark Massaro, BTIG.

（操作員說明）Mark Massaro，BTIG。

Hey, guys. Good morning. Thanks for the questions. The first one is, James, can you perhaps provide an update on communications you've received from the FDA?

大家好。早上好。感謝您的提問。第一個是，James，您能否提供一下您從 FDA 收到的通訊的最新情況？

I know you've indicated that you're hopeful to obtain approval by the end of June, end of this month. But I'd be curious to hear, like, are you still having some back-and-forth dialogue between you and the agency? And then, I know you've talked about how the agency plans to prepare reclassification order to complete its review. Just any update you could provide there, I think, would be helpful.

我知道您已經表示希望在六月底，即本月底之前獲得批准。但我很想知道，你和該機構之間是否仍在進行一些來回對話？然後，我知道您已經談到該機構計劃如何準備重新分類令以完成審查。我認為，您可以在那裡提供的任何更新都會有所幫助。

Yeah. Thanks, Mark. I have to be very careful. This is a sensitive time. And let me just say that we're very pleased with our communication with FDA. It has been iterative. And we think it is a very productive process.

是的。謝謝，馬克。我必須非常小心。這是一個敏感時期。我只想說，我們對與 FDA 的溝通感到非常滿意。它一直在迭代。我們認為這是一個非常富有成效的過程。

At the moment, we disclosed to the market, we expect a decision by the end of June. That's where we are at the moment. I will remind the market that until you have FDA, you don't have it. And we're just going to let the process continue to run. But at the moment, we're very optimistic.

目前，我們向市場透露，我們預計在六月底之前做出決定。這就是我們目前所處的情況。我會提醒市場，在獲得FDA之前，你還沒有獲得FDA。我們只是讓這個過程繼續運行。但目前，我們非常樂觀。

Okay. Great. Hopefully, that comes in, in the next few weeks or months. Maybe moving on to another question, maybe for O.J. I might have missed it. I didn't see the volumes reported in the quarter. I know in the prior quarter, you indicated they would be down sequentially due to the transition at Mount Sinai.

好的。偉大的。希望這會在接下來的幾週或幾個月內出現。也許繼續討論另一個問題，也許是針對 O.J.我可能錯過了。我沒有看到該季度報告的銷量。我知道在上一季度，您表示由於西奈山的過渡，它們將連續下降。

But can you just give us a sense for what the volumes were in the quarter? And then, as we think about the next quarter, would it be reasonable to assume that volumes can tick back up sequentially?

但您能否讓我們了解一下本季度的銷量？然後，當我們考慮下一個季度時，假設銷量可以依次回升是否合理？

So, volumes were just (technical difficulty) for the quarter, of which roughly two-thirds are billable. So, there's still a set of tests in there, Atrium Wake Forest, for example, that are part of study tests. They are not billable.

因此，該季度的銷量只是（技術難度），其中大約三分之二是可計費的。因此，那裡仍然有一組測試，例如 Atrium Wake Forest，這是研究測試的一部分。他們不收費。

So volumes are improving a bit in this quarter but offset by something we indicated in the call. Tests that used to be billable or reimbursed from Mount Sinai are not now under the traditional commercial pay model. And it represents about a third of the tests at Mount Sinai currently. So at the moment, we have that headwind against growth for the current quarter.

因此，本季度的銷量有所改善，但被我們在電話會議中指出的內容所抵消。過去由西奈山計費或報銷的測試現在不再採用傳統的商業付費模式。目前，它約佔西奈山測試的三分之一。因此，目前我們面臨著本季度增長的阻力。

We do expect that percentage to go down as a total of the Mount Sinai tests going forward as commercial tests ramp up. But also seeing continued growth and diversification away from Mount Sinai, primary care doctor, the independent PCP tests are increasing, et cetera. So, encouraged overall. But we do have that short-term impact from the Mount Sinai transition.

我們確實預計隨著西奈山測試總數的增加以及商業測試的增加，這一百分比將會下降。但也看到了遠離西奈山的持續增長和多樣化，初級保健醫生、獨立的 PCP 測試正在增加等等。因此，總體上受到鼓勵。但西奈山過渡確實給我們帶來了短期影響。

Okay. Sorry. I think you might have gone out. What were the volumes in the quarter?

好的。對不起。我想你可能已經出去了。該季度的銷量是多少？

Just over 1,200, about 1,240.

剛剛超過1,200，大約1,240。

Okay.

好的。

And about two-thirds of that are billable.

其中大約三分之二是可計費的。

Okay. I appreciate that. I think you indicated that the transition to commercial payment at Mount Sinai was completed. Is that right? So, I know that testing at Mount Sinai was paused in March. Given the transition at Mount Sinai, is it right that we should expect more of a normal cadence of volume growth going forward? Or is there still a little bit of work to do to get that sort of squared away?

好的。我很感激。我認為您表示西奈山嚮商業支付的過渡已經完成。是對的嗎？所以，我知道西奈山的測試已於三月份暫停。鑑於西奈山的轉變，我們是否應該期待未來銷量增長的正常節奏？或者是否還需要做一些工作才能解決這個問題？

No. Total volumes are back, but the ongoing impact is that a third of those -- currently a third, hopefully, less going forward, are no longer billable. Whereas when we were under the $6 million contract at Mount Sinai, we were getting paid for those. Those are study tests that are not commercially billable at the moment. So, while volumes are back, a third of them are not revenue generating.

不。總銷量已經恢復，但持續的影響是其中三分之一（目前是三分之一，希望未來會減少）不再收費。而當我們在西奈山簽訂價值 600 萬美元的合同時，我們就得到了報酬。這些是目前無法進行商業收費的研究測試。因此，雖然銷量有所回升，但其中三分之一併沒有產生收入。

Okay. That makes sense. And I would be curious to just get an update on the EVERSANA partnership. It seems like it's a contract sales organization if that's a fair way to characterize them. How many folks do you think you have access to, boots on the ground, sales reps? And I know you indicated that they could become employees of Renalytix going forward. Maybe just walk me through how you expect that type of transition to play out.

好的。這就說得通了。我很想了解 EVERSANA 合作夥伴關係的最新信息。如果這是一個公平的描述他們的方式的話，它似乎是一個合同銷售組織。您認為您可以接觸到多少人、現場工作人員、銷售代表？我知道您表示他們將來可能會成為 Renalytix 的員工。也許請告訴我您期望這種類型的轉變如何進行。

So, actually, I'm glad you brought this up, Mark. It is not a contract sales organization. In fact, we've had a relatively negative reaction to contract sales over our careers. And especially when you are looking at a new product like KidneyIntelX, which needs to be marketed in a very specific way. Simple way, but a very specific way, you need to have dedicated to sales resources.

所以，實際上，我很高興你提出這個問題，馬克。它不是合同銷售組織。事實上，在我們的職業生涯中，我們對合同銷售的反應相對消極。尤其是當您考慮像 KidneyIntelX 這樣的新產品時，它需要以非常具體的方式進行營銷。簡單的方法，但是非常具體的方法，你需要有專門的銷售資源。

So, EVERSANA for us allows a couple of things. One, they bring a significant infrastructure in place in a network which allows us to get access to qualified salespeople much more quickly than we could on our own. It allows us to understand all the salespeople and characterize them before we put them in the field because they have the ability to screen and evaluate those salespeople in a very sophisticated way.

因此，EVERSANA 對我們來說允許做一些事情。第一，他們在網絡中建立了重要的基礎設施，使我們能夠比我們自己更快地接觸到合格的銷售人員。它使我們能夠在將所有銷售人員派往現場之前了解並描述他們的特徵，因為他們有能力以非常複雜的方式篩选和評估這些銷售人員。

But these are salespeople that are 100% dedicated to Renalytix. So, it's not a contract sales force that's carrying multiple things in the bag. These folks are coming in as dedicated people for KidneyIntelX. And the anticipation is that they will actually convert into W2 employees of Renalytix.

但這些銷售人員 100% 致力於 Renalytix。因此，這並不是一個包攬多項東西的合同銷售人員。這些人是作為 KidneyIntelX 的奉獻者加入的。預計他們將真正轉變為 Renalytix 的 W2 員工。

So, EVERSANA allows us to accelerate that hiring process and put resources where we now have significant developing insurance coverage, a supermajority concept and in populations where there's a lot of diabetes and kidney disease. And it just made sense for us to do it. We're starting out small. So we're looking at two regions to deploy. I think we're starting out with a total of -- I'll let Tom comment on the scope, but we're not going wild here.

因此，EVERSANA 使我們能夠加快招聘流程，並將資源投入到我們現在擁有大量發展中的保險覆蓋範圍、絕對多數概念以及患有大量糖尿病和腎病的人群中。我們這樣做是有意義的。我們從小事做起。因此，我們正在考慮部署兩個區域。我認為我們一開始的總規模是——我會讓湯姆評論一下範圍，但我們不會在這裡瘋狂。

Let's get resources in place and demonstrate a specific ROI that we can achieve and show it. And then, now we have a model to start expanding and scaling more rapidly with increasing insurance coverage. And we're sure that the model works. Tom, do you want to comment further?

讓我們準備好資源，展示我們可以實現並展示的具體投資回報率。然後，現在我們有了一個模型，可以隨著保險覆蓋範圍的增加而開始更快地擴展和擴展。我們確信該模型有效。湯姆，你想進一步發表評論嗎？

Thanks, James. Yes. So Mark, EVERSANA didn't get to be the leader in this area. And they are the leader worldwide without offering a continuum of options for companies. And in the case of Renalytix, Renalytix is involved in the hiring of the account execs into these territories.

謝謝，詹姆斯。是的。所以馬克，EVERSANA 並沒有成為這個領域的領導者。他們是全球領先者，但卻沒有為公司提供連續的選擇。就 Renalytix 而言，Renalytix 參與了這些地區客戶經理的招聘。

We make the decision as to whether they are appropriate for the business we have. EVERSANA is a part of that recruiting process. Those EVERSANA account execs will report to a Renalytix regional sales director, and they are members of the team. And so, everything that EVERSANA brings into Renalytix that gives us the power of a much bigger company when we're a very small company in terms of learning management and other capabilities that we wouldn't be able to afford for another three years or five years. That's going to be made available to our entire sales force.

我們決定它們是否適合我們的業務。 EVERSANA 是招聘流程的一部分。這些 EVERSANA 客戶主管將向 Renalytix 區域銷售總監匯報，他們也是團隊成員。因此，EVERSANA 為 Renalytix 帶來的一切，讓我們在學習管理和其他能力方面擁有了一家大公司的力量，而我們是一家非常小的公司，而這些能力是我們在未來三年或五年內無法承擔的年。這將提供給我們整個銷售團隊。

So, this is not a contract sales relationship. This is going to be one where it is highly synergistic. We can think of this as a combined sales force. And the value that both Renalytix and EVERSANA will bring in commercialization. It's a true partnership here. These are KidneyIntelX account execs, whether they get a paycheck from Renalytix or a paycheck from EVERSANA at the end of the day.

因此，這不是合同銷售關係。這將是一個高度協同的領域。我們可以將其視為一支聯合銷售隊伍。以及 Renalytix 和 EVERSANA 將在商業化中帶來的價值。這是真正的合作夥伴關係。這些是 KidneyIntelX 客戶經理，無論他們最終是從 Renalytix 獲得薪水還是從 EVERSANA 獲得薪水。

In terms of focus, we have identified three key markets in Texas and three key markets in Florida for launch of KidneyIntelX with all of the outcomes evidence, the payer commitment, the regulatory demonstration that it is a reliable, repeatable technology. Those markets that will be key to showing that with everything we have learned that we are in a position now that we can, with our messaging with all of the tools that Renalytix and EVERSANA bring that we can accelerate our development into new markets.

在重點方面，我們確定了德克薩斯州的三個主要市場和佛羅里達州的三個主要市場，以推出 KidneyIntelX，並提供所有結果證據、付款人承諾、監管證明，證明它是一項可靠、可重複的技術。這些市場將是關鍵，通過我們所了解到的一切，我們現在可以利用 Renalytix 和 EVERSANA 帶來的所有工具傳遞信息，表明我們可以加速新市場的開發。

So, that gives you a better understanding of the parameters or the scope of this first phase. And we hope that it proves to be very successful. And it is a first phase with EVERSANA so that we know working with them we can accelerate rapidly in other markets as we have the evidence that KidneyIntelX will be successful in that primary care practice area.

因此，這可以讓您更好地了解第一階段的參數或範圍。我們希望它會非常成功。這是 EVERSANA 的第一階段，因此我們知道與他們合作，我們可以在其他市場迅速加速，因為我們有證據表明 KidneyIntelX 將在初級保健實踐領域取得成功。

Okay, great. Thanks for all the color. That's it for me.

好的，太好了。感謝所有的顏色。對我來說就是這樣。

Thanks, Mark.

謝謝，馬克。

Randy Baron, Pinnacle.

蘭迪·巴倫，巔峰之作。

Hi, guys. Good morning. I have two questions. The first is for O.J. I totally get that we're not giving guidance on test. But I'm really curious about the glide path for the billable percentage? And how should we model that out? Do you think by the end of this calendar year, we're 80% billable? Like, just directionally, when do we get towards kind of 100% billable on the tests?

嗨，大家好。早上好。我有兩個問題。第一個是給 O.J.我完全明白我們沒有提供測試指導。但我真的很好奇計費百分比的下滑路徑？我們應該如何建模呢？您認為到今年年底，我們的計費率將達到 80% 嗎？就像，就方向而言，我們什麼時候才能實現 100% 的測試計費？

As long as we're doing studies on future products and so forth, there will always be some portion of the tests that are not billable. But at the moment, study tests are relatively constant. And as we grow the business and develop commercially, we should see billable tests increasing as a percentage of the total, certainly.

只要我們對未來的產品等進行研究，總會有一些測試是不收費的。但目前，學習測試相對穩定。隨著我們業務的發展和商業化的發展，我們肯定會看到計費測試佔總數的百分比不斷增加。

So, let's see how the new sales initiatives are taking hold in the months and quarters ahead as well as, hopefully, messaging around positive FDA approval. And I would expect that to continue to build the commercial side of things.

因此，讓我們看看新的銷售計劃在未來幾個月和幾個季度如何實施，以及如何圍繞 FDA 的積極批准傳遞信息。我希望這將繼續發展商業方面。

Let me ask the question this way. Is the current rate of study tests, is that kind of a constant number. Are studies ever going to be thousands of tests, or is it always kind of be in that 100 range? So, as you model those out, kind of a year or two. I get that there's always -- I just don't know enough about studies. Does it ever become 10,000 tests?

讓我這樣問這個問題。目前的學習測試率，是一個恆定的數字。研究是否會進行數千次測試，還是總是在 100 次範圍內？因此，當你對這些進行建模時，需要一兩年的時間。我知道總是有的——我只是對學習了解不夠。它會成為 10,000 次測試嗎？

It depends. That wouldn't necessarily be a set. If study tests go up, it means we have future iterations or products that we're working with and developing. So, there's no concrete forecast or plan at the moment for what those study test volumes will look like in the future. It all depends on how things build.

這取決於。那不一定是一個集合。如果研究測試上升，則意味著我們有未來的迭代或正在開發的產品。因此，目前還沒有關於未來這些研究測試量的具體預測或計劃。這一切都取決於事情如何構建。

The R&D team is active in assessing additional biomarkers, indications and so forth. So, the work continues there. So, that should have an impact in many years to add on.

研發團隊積極評估其他生物標誌物、適應症等。因此，工作仍在繼續。因此，這應該會在很多年後產生影響。

And will study -- will it generate cash upfront? Is that kind of the trade-off?

並將研究——它會預先產生現金嗎？這是一種權衡嗎？

It varies. This study is really not a case where there's an awful lot of cash up front. It's just the test as they run. They're just not billable. So, we absorb the cost of these tests.

它有所不同。這項研究實際上並不是需要大量現金的情況。這只是他們運行時的測試。他們只是不收費。因此，我們承擔了這些測試的成本。

Okay. And James, I mean, obviously, the tone today very positive, which is great. And I know you're cautiously optimistic on FDA. And who knows what comes out of Washington. But assuming you get that positive regulatory outlook in the next couple of weeks, which is what it sounds like from your press release. Can you just give us high level what you think, the milestones you're looking for later this year?

好的。詹姆斯，我的意思是，顯然，今天的語氣非常積極，這很棒。我知道您對 FDA 持謹慎樂觀的態度。誰知道華盛頓會發生什麼。但假設你在接下來的幾週內獲得了積極的監管前景，正如你的新聞稿所聽起來的那樣。您能否向我們簡單介紹一下您的想法以及您在今年晚些時候尋求的里程碑？

I mean, it seems like there's a thunder cloud on the horizon. You've got the sales force ramp. And you've got insurance approval. Just looking out for the rest of this calendar year, assuming you get FDA, how should we think about how the business could really evolve and evolve at an exponential rate?

我的意思是，地平線上似乎有一片雷雨雲。您的銷售隊伍已經壯大。並且您已獲得保險批准。展望今年剩下的時間，假設你獲得 FDA 批准，我們應該如何思考業務如何真正發展並以指數速度發展？

Yeah. FDA is obviously a major validation, especially coming out of de novo marketing authorization. It is de novo. It's new. It does allow us to change and simplify the conversation with payers and with physicians.

是的。 FDA 顯然是一個重要的驗證，特別是來自新的營銷授權。這是從頭開始的。這是新的。它確實使我們能夠改變和簡化與付款人和醫生的對話。

Physicians we can now walk into an office and say, it's FDA authorized. So, that removes any doubt around, is this experimental. And again, the thing that we're learning more than anything else is, the simpler the message, the more effective the sales ramp and the easier time we're going to have with adoption.

醫生們，我們現在可以走進辦公室說，這是 FDA 授權的。所以，這消除了任何疑問，這是實驗性的。再說一遍，我們學到的最重要的一點是，信息越簡單，銷售增長就越有效，我們就越容易採用。

And getting to simplicity, as we all know, from experience is difficult. The simplest messages are often difficult, especially in a complex regulatory environment of medical devices and especially with the power of KidneyIntelX coming off of the AI enablement, coming off of the huge clinical data, and how does it relate to outcomes, et cetera.

眾所周知，從經驗中獲得簡單性是很困難的。最簡單的信息往往很困難，特別是在復雜的醫療設備監管環境中，尤其是在 KidneyIntelX 的強大功能來自於人工智能的支持、來自龐大的臨床數據以及它與結果的關係等方面。

So getting to that very simple message so that a primary care physician who is often overwhelmed, they're dealing with a complex disease can very simply say, oh, okay, FDA approved. I don't have to worry about insurance. And boy, here's the data. If I use this thing, my patient is going to get better. That's a pretty simple message.

因此，傳達一個非常簡單的信息，以便經常不知所措的初級保健醫生，他們正在處理一種複雜的疾病，可以非常簡單地說，哦，好吧，FDA 批准了。我不用擔心保險問題。天哪，這是數據。如果我使用這個東西，我的病人就會好起來。這是一條非常簡單的消息。

Of course, it takes you tens of millions of dollars and multiple years and all this complexity to get to the point where you can legitimately say that. So, I think the setup for the back end of this year is, for us, fascinating. And we are very optimistic because we're able to carry this incredibly simple but powerful message into the physician office, where there's a clear unmet need.

當然，你需要花費數千萬美元和多年的時間以及所有這些複雜性才能達到你可以合法地說出這一點的程度。因此，我認為今年年底的安排對我們來說非常有趣。我們非常樂觀，因為我們能夠將這個極其簡單但有力的信息傳遞到醫生辦公室，那裡有明顯未滿足的需求。

No one has come back to us to say, you know it's nice. I don't need this. Especially among primary care, everybody needs it. We need a way to be able to identify who's at high risk in these very large populations. So, we understand who we can treat because you can't treat them all.

沒有人回來告訴我們，你知道這很好。我不需要這個。尤其是在初級保健中，每個人都需要它。我們需要一種方法來識別這些龐大人群中的高危人群。因此，我們了解我們可以治療哪些人，因為您無法治療所有人。

There are too many people with diabetes and kidney disease. You need a simple, rapid way to say here's a patient with kidney disease that really matters, I got to focus on them. And because we have new drugs now that really work, there's a very simple solution here.

患有糖尿病和腎病的人太多了。你需要一種簡單、快速的方式來表明這是一位患有腎病的患者，這確實很重要，我必須關注他們。因為我們現在有了真正有效的新藥，所以這裡有一個非常簡單的解決方案。

So, I am very optimistic about the future to drive growth, which is one of the reasons we got a hold of EVERSANA, who both Tom and I have worked with in the past. And it does give us the resources to deploy with a higher degree of confidence that they're effective resources. And that we can target an ROI, where we can really target an IRR. And we can make sure that investing in these resources are going to generate return with this simple message. So yes, I'm very confident going into the second half of this year that the seas are going to calm a little bit.

因此，我對推動增長的未來非常樂觀，這也是我們獲得 EVERSANA 的原因之一，我和 Tom 過去都曾與該公司合作過。它確實使我們能夠更加自信地部署資源，相信它們是有效的資源。我們可以以投資回報率為目標，我們可以真正以內部收益率為目標。通過這個簡單的信息，我們可以確保對這些資源的投資將產生回報。所以，是的，我非常有信心進入今年下半年，大海會稍微平靜一些。

And we also have, Randy, a ton of experience now. Partnering up with Mount Sinai and getting in early and being able to use KidneyIntelX in the wild was incredibly valuable. And I haven't done that in previous companies. I'm delighted we did it now because we get a real, in-the-world experience with what happens with KidneyIntelX.

蘭迪，我們現在也擁有大量的經驗。與西奈山合作並儘早參與並能夠在野外使用 KidneyIntelX 非常有價值。我在以前的公司裡沒有這樣做過。我很高興我們現在就這樣做了，因為我們對 KidneyIntelX 所發生的事情有了真實的、真實的體驗。

So now that gives us the capacity when we move out into other territories, we've got a great data set that we can draw from. And the product becomes much more clear in terms of the messaging. So, I think, having the three legs of the stool, the trifecta has been, as Dan said earlier, a long winding road. But we're arriving at that station with the trifecta. And I think it's ours to lose at this point.

現在，當我們進入其他地區時，這為我們提供了能力，我們擁有了可以從中提取的大量數據集。而且產品在消息傳遞方面變得更加清晰。因此，我認為，正如丹之前所說，凳子的三條腿，三連勝是一條漫長而曲折的道路。但我們正帶著三連勝到達那個車站。我認為此時此刻我們輸了。

Good luck

祝你好運

Thank you. (Operator Instructions) Speakers, I am seeing no further questions in the queue. This means that this will conclude today's conference call. Thank you all for participating. You may now disconnect. Have a pleasant day. And enjoy your weekend.

謝謝。 （操作員指示）發言者，我在隊列中沒有看到其他問題。這意味著今天的電話會議將結束。感謝大家的參與。您現在可以斷開連接。祝你有愉快的一天。祝你周末愉快。