Renalytix PLC (RNLX) 2023 Q4 法說會逐字稿

Good morning and welcome to the Renalytix conference call to review fourth quarter and full year fiscal 2023 financial results. (Operator Instructions). I would now like to turn the call over to Peter DeNardo of CapComm Partners for a few introductory comments. Please go ahead.

早安，歡迎參加 Renalytix 電話會議，回顧 2023 財年第四季和全年財務表現。 （操作員說明）。我現在想將電話轉給 CapComm Partners 的 Peter DeNardo，請其發表一些介紹性意見。請繼續。

Thank you, Michelle, and 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.

謝謝米歇爾，也謝謝大家參加今天的電話會議。今天，Renalytix 執行長 James McCullough 與我一起發表正式演講；湯姆‧麥克萊恩 (Tom McLain)，總裁；詹姆斯‧斯特林 (James Sterling)，財務長。

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. Any statements made during this call that relate to expectations or predictions of future results, and events or performance, are forward-looking statements.

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。或預測相關的聲明未來結果、事件或績效的陳述均為前瞻性陳述。

Examples of these statements include -- without limitation -- the potential benefits, including economic savings, of KidneyIntelX; 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.

這些陳述的例子包括（但不限於）KidneyIntelX 的潛在好處，包括經濟節約； KidneyIntelX的商業前景，包括KidneyIntelX是否會成功被醫生採用並分銷和行銷；我們對報銷決定的期望； KidneyIntelX 能夠降低慢性和末期腎病的成本、優化護理服務並改善患者的治療效果；我們的市場趨勢以及政府政策變化的潛在好處； COVID-19 和其他世界事件對我們業務的影響；我們對招募、產品開發、策略夥伴關係和協作的期望；報銷決定；臨床研究和監管提交；我們的業務策略和未來成長，包括為我們的營運融資的計劃、期望和機會；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 10-K that was filed today, September 28, 2023, 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有重大差異。因此，您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的描述，請參閱我們於今天（2023 年 9 月 28 日）向美國證券交易委員會提交的 10-K 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, September 28, 2023.

本次電話會議中所做的所有前瞻性陳述均基於管理層目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，無論是因為新資訊、未來事件或其他原因。本次電話會議包含時效性訊息，僅截至今天（2023 年 9 月 28 日）直播時準確。

I'll now turn the call over to James McCullough. James?

我現在將把電話轉給詹姆斯·麥卡洛。詹姆士？

Thank you, Peter. Good morning -- good afternoon. In short order around this quarterly period, we crossed major thresholds and reimbursement outcomes data and achieved an FDA de novo marketing authorization for KidneyIntelX. Our progress was further amplified by inclusion of KidneyIntelX in the draft-leading kidney care guidelines -- KDIGO -- for 2023.

謝謝你，彼得。早安，下午好。在本季度的短時間內，我們跨越了主要閾值和報銷結果數據，並獲得了 FDA 對 KidneyIntelX 的從頭開始行銷授權。透過將 KidneyIntelX 納入 2023 年領先的腎臟護理指南草案——KDIGO，我們的進展得到了進一步放大。

It is rare to see all of these milestones passed sequentially -- measured in months -- and we believe that these are significant for the broader adoption and clinical acceptance of KidneyIntelX for early prognosis of individuals with type 2 diabetes and early-stage kidney disease in the United States and abroad.

很少看到所有這些里程碑依次通過（以月為單位），我們相信這些對於更廣泛地採用和臨床接受 KidneyIntelX 對於 2 型糖尿病和早期腎病患者的早期預後具有重要意義。

On the growth equation, achieving these collective milestones now allows us to set the commercial target of a 1% United States market penetration over the next three years -- and our FDA-authorized indicated use population of 14 million adults with diabetes and kidney disease. We intend to do this through expanding hospital system partnerships, working closely with insurance companies covering KidneyIntelX, and through our direct-to-physician salesforce whose expansion is continuing in specific areas in the United States under the new leadership of experienced sales executive Howard Doran.

在成長方程式上，實現這些集體里程碑現在使我們能夠設定未來三年美國市場滲透率 1% 的商業目標，並且 FDA 授權的指示使用人群為 1400 萬患有糖尿病和腎病的成年人。我們打算透過擴大醫院系統合作夥伴關係、與涵蓋KidneyIntelX 的保險公司密切合作以及透過我們的直接面向醫生的銷售團隊來實現這一目標，在經驗豐富的銷售主管Howard Doran 的新領導下，我們的銷售隊伍正在美國特定地區繼續擴張。

In addition, the international opportunity with FDA in hand is also quite promising, particularly given the large growth in diabetes globally. As a reminder, we have been disciplined in maintaining a $950 price point or greater in our growing portfolio contracted insurance companies. This pricing was originally set by Medicare.

此外，FDA 掌握的國際機會也相當有前景，特別是考慮到全球糖尿病的大幅成長。提醒一下，我們一直嚴格要求將我們不斷成長的投資組合簽約保險公司維持在 950 美元或更高的價格點。該定價最初由 Medicare 制定。

Importantly, post FDA authority, we have reviewed our operating cost basis and are taking decisive actions to reduce our quarterly cash burn rate. This reduction in cash burn should become most apparent in the second half of fiscal 2024 and is being undertaken without compromising our sales focus on growing testing volume and revenue. These reductions on top of our net year-over-year OpEx reduction of $11 million. We will continue to look for opportunities to optimize cash expenditure and increase our cash position, particularly through non-or-less-dilutive strategic partnering, and potential international licensing opportunities.

重要的是，在 FDA 授權後，我們已經審查了我們的營運成本基礎，並正在採取果斷行動來降低我們的季度現金消耗率。現金消耗的減少應該在 2024 財年下半年最為明顯，並且不會影響我們對不斷增長的測試量和收入的銷售重點。這些減少是在我們的營運支出年比淨減少 1,100 萬美元的基礎上實現的。我們將繼續尋找優化現金支出和增加現金狀況的機會，特別是透過非或較少稀釋的策略合作夥伴關係以及潛在的國際授權機會。

As far as we are aware, KidneyIntelX is now the only machine learning-enabled prognostic tool in chronic disease preventative medicine with an FDA authorization; established payment by a broad array of insurance companies, including Blue Cross Blue Shield groups, Medicare, and Medicaid; and real-world evidence demonstrating improved outcomes in both diabetes and kidney disease.

據我們所知，KidneyIntelX 目前是慢性病預防醫學領域唯一獲得 FDA 授權的機器學習預測工具；由許多保險公司建立付款方式，包括 Blue Cross Blue Shield 集團、Medicare 和 Medicaid；現實世界的證據顯示糖尿病和腎臟疾病的結果得到改善。

After a four year FDA process -- which included over one million patient calculations, three independent train test validate algorithm runs -- we are proud KidneyIntelX has validated a novel pathway for artificial intelligence enabled in vitro diagnostic medicine. Several hard won regulatory innovations, including validation of a nonlinear machine learning algorithm; use of electronic medical record features; new predictive biomarkers; and importantly, accurate and reliable prognosis from the earliest starting point in a chronic disease category, all provide KidneyIntelX with unique competitive positioning.

經過四年的 FDA 流程（包括超過 100 萬患者計算、三個獨立的訓練測試驗證演算法運行），我們感到自豪的是 KidneyIntelX 已經驗證了一種人工智慧體外診斷醫學的新途徑。幾項來之不易的監管創新，包括非線性機器學習演算法的驗證；使用電子病歷功能；新的預測生物標記；重要的是，從慢性疾病類別的最早起點開始準確可靠的預後，都為 KidneyIntelX 提供了獨特的競爭定位。

Our view is these precedents, solidified in a full regulatory process, will be difficult to replicate without a considerable investment over a multiyear period. In short, we are very pleased with our established long-term competitive advantages.

我們認為，如果沒有多年的大量投資，這些先例在全面的監管過程中得到鞏固，將很難複製。簡而言之，我們對我們已建立的長期競爭優勢感到非常滿意。

As I noted earlier, we are pleased to have announced that senior executive Howard Doran has joined Renalytix to lead the global business effort, including US direct-to-physician sales efforts. As of September, our direct-to-physician salesforce is now active in several territories in the United States: in Texas; Florida; New York; and North Carolina -- all where the rates of diabetic kidney disease are high, where we have existing or anticipated hospital partners, and where our insurance coverage, in many cases, exceeds 90% of the FDA authorized indicated use population.

正如我之前指出的，我們很高興地宣布高級管理人員 Howard Doran 已加入 Renalytix 來領導全球業務工作，包括美國直接面向醫生的銷售工作。截至 9 月份，我們的直接面向醫生的銷售隊伍現已活躍在美國的多個地區：德克薩斯州；佛羅裡達;紐約;和北卡羅來納州——糖尿病腎病發病率很高，我們有現有或預期的醫院合作夥伴，而且我們的保險覆蓋範圍在許多情況下超過 FDA 授權的指定使用人群的 90%。

We believe a number of pharmaceutical and medical device industry players would benefit from KidneyIntelX-driven patient prognosis and supportive care management in the diabetes market. Recently, published data has shown that primary care physicians using KidneyIntelX are four times more likely to prescribe GLP-1 agonists and SGLT2 inhibitors early on to diabetes patients at significant risk of kidney function decline.

我們相信許多製藥和醫療器材行業參與者將從 KidneyIntelX 驅動的糖尿病市場患者預後和支持性護理管理中受益。最近公佈的數據顯示，使用 KidneyIntelX 的初級保健醫生早期向腎功能下降風險顯著的糖尿病患者開出 GLP-1 激動劑和 SGLT2 抑制劑的可能性高出四倍。

By identifying kidney care disease patients at risk early by using KidneyIntelX, the potential increase in new drug therapy use, particularly at the primary care level, for pharmaceutical players is compelling. Ongoing publication of both our own and third party KidneyIntelX outcomes and utility data are critical for establishing a new broadly-used preventative standard of care.

透過使用 KidneyIntelX 及早識別處於危險中的腎臟病患者，新藥治療的使用潛在增加，特別是在初級保健層面，對於製藥企業來說是引人注目的。我們自己和第三方不斷發布的 KidneyIntelX 結果和實用數據對於建立新的廣泛使用的預防性護理標準至關重要。

At Renalytix, we have invested heavily in real-world evidence generation since we began full operations in late 2018. As we presented in this quarter, KidneyIntelX outcomes data has exceeded our expectation by showing an association with clinical actions that -- in under 12 months -- led to observable changes in the core measure for diabetes health and kidney health. Raising funds to fuel these clear commercial opportunities is essential, particularly now that we have reduced risks associated with the successful service product launch and adoption.

在 Renalytix，自 2018 年底開始全面運作以來，我們在現實世界證據生成方面投入了大量資金。 ——導致糖尿病健康和腎臟健康的核心指標發生明顯變化。籌集資金來推動這些明確的商業機會至關重要，特別是現在我們已經降低了與成功推出和採用服務產品相關的風險。

To maximize our flexibility to fund business growth, we filed an S-3 shelf registration statement to give us the ability to source capital at the right time. Again, we will continue to explore less dilutive and nondilutive capital funding sources, particularly now that we have a unique product proposition post-FDA authorization.

為了最大限度地提高為業務成長提供資金的靈活性，我們提交了 S-3 擱置註冊聲明，使我們能夠在正確的時間籌集資金。同樣，我們將繼續探索稀釋性較小且非稀釋性的資本融資來源，特別是現在我們在 FDA 授權後擁有獨特的產品主張。

I will now turn over to Tom McLain, our President, to discuss reimbursement activities and accomplishments during the period. Tom?

我現在將請我們的總統湯姆·麥克萊恩討論這段時期的報銷活動和成就。湯姆？

(technical difficulty)

（技術難度）

It sounds like we're having a communication -- with Tom -- with your communication issue. I'll go ahead and read Tom's script for the moment.

聽起來我們正在與湯姆就您的溝通問題進行溝通。我暫時先讀一下湯姆的劇本。

What Tom is going to say is, following much hard work to accomplish the momentous task of achieving FDA authorization, we now believe that the KidneyIntelX deployment road ahead of us is wide open to accelerate test adoption. As James indicated, KidneyIntelX.dkd is now the only prognostic in vitro diagnostic test for assessment of chronic kidney disease progression with FDA authorization.

Tom 想說的是，經過艱苦努力完成獲得 FDA 授權的艱鉅任務，我們現在相信擺在我們面前的 KidneyIntelX 部署道路已經敞開，可以加速測試的採用。正如 James 所指出的，KidneyIntelX.dkd 目前是唯一獲得 FDA 授權的用於評估慢性腎病進展的預後體外診斷測試。

Since we announced this at the end of June, our ability to engage in conversations with partners and payers has been elevated to a new exciting level. Following the announcement of FDA authorization, the Medicare administrative contractor responsible for test claim payment, coming from our samples processed in our New York laboratory, convened a contractor advisory committee meeting or CAC meeting.

自從我們在 6 月底宣布這一消息以來，我們與合作夥伴和付款人進行對話的能力已經提升到了一個令人興奮的新水平。在 FDA 授權宣布後，負責支付來自我們在紐約實驗室處理的樣本的測試索賠費用的 Medicare 行政承包商召開了承包商諮詢委員會會議或 CAC 會議。

A CAC meeting is recommended under the 21st Century Cures Act as part of the advancing the local coverage determination process. The purpose of the meeting was to discuss the clinical literature that supports advancing the development of a local coverage determination. There were a number of highly interactive discussions regarding the clinical utility of KidneyIntelX by independent physicians selected by national government services. We were pleased with the outcome of the meeting and supported the dialogue by submitting a summary of how the evidence addresses questions posed to the CAC panel during the meeting.

《21 世紀治癒法案》建議召開 CAC 會議，作為推動當地覆蓋範圍確定流程的一部分。會議的目的是討論支持推進局部覆蓋確定發展的臨床文獻。由國家政府部門挑選的獨立醫生就 KidneyIntelX 的臨床實用性進行了許多高度互動的討論。我們對會議的結果感到滿意，並透過提交證據如何解決會議期間向 CAC 專家小組提出的問題的摘要來支持對話。

In summary, and especially following FDA authorization, we continue to be confident in our ability to secure a coverage determination from Medicare. In keeping with our stated strategic goal of focusing our commercial efforts on regional areas where we can bring the benefits of our KidneyIntelX technology to large populations of adults, we recently announced expansion of insurance coverage in Texas. This was the result of executing a contract with Blue Cross and Blue Shield of Texas, the largest statewide healthcare plan covering 7 million members in all 254 Texas counties. This organization works with more than 140,000 physicians, and healthcare practitioners, and 520 hospitals.

總之，特別是在 FDA 授權之後，我們仍然對我們獲得 Medicare 承保範圍決定的能力充滿信心。為了實現我們既定的策略目標，即將我們的商業努力集中在能夠將 KidneyIntelX 技術的優勢帶給大量成年人的地區，我們最近宣布擴大德州的保險覆蓋範圍。這是與德克薩斯州 Blue Cross 和 Blue Shield 簽訂合約的結果，這是最大的全州醫療保健計劃，涵蓋德克薩斯州所有 254 個縣的 700 萬會員。該組織與超過 140,000 名醫生和醫療保健從業人員以及 520 家醫院合作。

Furthermore, we also executed an agreement for insurance coverage of KidneyIntelX with Parkland Community Health Plan, a Dallas-based insurance plan with over 300,000 covered lives and services seven counties. As a reminder, these regional agreements complement coverage already secured and announced previously, whereby Blue Cross Blue Shield plans cover our test across millions of covered lives in Illinois, Maryland, Virginia, Iowa, and South Dakota.

此外，我們還與 Parkland Community Health Plan 簽署了 KidneyIntelX 保險承保協議，Parkland Community Health Plan 是一家總部位於達拉斯的保險計劃，覆蓋超過 30 萬人，為七個縣提供服務。提醒一下，這些區域協議補充了先前已經獲得和宣布的保險範圍，其中Blue Cross Blue Shield 計劃涵蓋了我們對伊利諾伊州、馬裡蘭州、弗吉尼亞州、愛荷華州和南達科他州數百萬受保人的測試。

It is unusual to achieve this level of comprehensive insurance reimbursement with such a short operating history. We expect our success with coverage will accelerate now that we have completed regulatory, real-world evidence, and clinical use milestones. Also, this level of insurance payment is an important validation of KidneyIntelX and a key component of the intrinsic value of the franchise for potential strategic partners.

在經營歷史如此短的情況下，實現如此全面的保險報銷水平，實屬罕見。既然我們已經完成了監管、現實世界證據和臨床使用的里程碑，我們預計我們在覆蓋範圍方面的成功將會加速。此外，這種水準的保險支付是對 KidneyIntelX 的重要驗證，也是潛在策略夥伴特許經營內在價值的關鍵組成部分。

I would now like to turn the call over to James Sterling, who will discuss our financial results for the quarter and the year. James?

我現在想將電話轉給詹姆斯·斯特林，他將討論我們本季和全年的財務業績。詹姆士？

Good morning. Today, we issued the financial results for our 2023 fiscal year, which ended June 30. Our GAAP financials were filed today on Form 10-K and will be followed shortly by our annual report under IFRS accounting. Figures I will discuss here are based on our GAAP financials, and quoted in US dollars which is our reporting currency.

早安.今天，我們發布了截至 6 月 30 日的 2023 財年財務業績。我將在這裡討論的數字基於我們的 GAAP 財務數據，並以我們的報告貨幣美元報價。

We recorded total revenue of $3.4 million for fiscal year 2023, which was up about 15% over fiscal '22. During fiscal 2023, we recognized services revenue of nearly $300,000 upon completion of two services contracts, including our projects with AstraZeneca. For the fourth quarter, we recorded revenue of $520,000 compared to $830,000 for the fourth quarter of the prior fiscal year. As we noted on last quarter's call, revenue has been impacted by the successful transition to commercial payment for testing at Mount Sinai. While total testing volume has remained relatively steady, certain clinical trial tests that were billable under the prior contract at Mount Sinai are no longer billable under the commercial model. Upon completion of study enrollment, we expect the percentage of billable tests to increase over the latter part of fiscal 2024.

我們 2023 財年的總營收為 340 萬美元，比 22 財年成長了約 15%。在 2023 財年，我們在完成兩份服務合約（包括我們與阿斯特捷利康的專案）後確認了近 30 萬美元的服務收入。第四季的營收為 52 萬美元，而上一財年第四季的營收為 83 萬美元。正如我們在上季度的電話會議中指出的那樣，西奈山測試成功過渡到商業付款對收入產生了影響。雖然總檢測量保持相對穩定，但根據西奈山先前合約計費的某些臨床試驗測試不再根據商業模式計費。研究註冊完成後，我們預計收費測試的百分比將在 2024 財年下半年增加。

Operating expenses for the fourth quarter were $9.8 million on a GAAP basis, significantly reduced from $13.2 million for the prior year period. This reflects the result of actions we previously took to lower operating expenses through program, vendor, and employee reductions.

以 GAAP 計算，第四季營運費用為 980 萬美元，較上年同期的 1,320 萬美元大幅減少。這反映了我們先前透過減少計劃、供應商和員工來降低營運費用所採取的行動的結果。

Net loss for the fourth quarter of fiscal 2023 was $11.1 million, or $0.11 per share. This compared to a net loss of $5.2 million or $0.07 per share for the fourth quarter of fiscal 2022, which included a foreign currency gain of $5.1 million. Excluding the foreign currency gain, net loss for the year-ago period would have been $10.2 million, or $0.14 per share.

2023 財年第四季的淨虧損為 1,110 萬美元，即每股 0.11 美元。相比之下，2022 財年第四季淨虧損 520 萬美元，即每股 0.07 美元，其中包括 510 萬美元的外匯收益。排除外匯收益，去年同期淨虧損為 1,020 萬美元，即每股 0.14 美元。

We continue to maintain a tight focus on controlling expenses. As a result, for the year ended June 30, net cash used in operating activities was about $33.4 million, and this was down 27% from $45.9 million in the prior fiscal year. We ended the fourth quarter with approximately $24.7 million in cash as of June 30, And as James mentioned, we're in the process of taking steps to further reduce our operating expenses to extend our cash runway.

我們繼續密切關注控制費用。因此，截至 6 月 30 日的年度，經營活動使用的淨現金約為 3,340 萬美元，比上一財年的 4,590 萬美元下降了 27%。截至 6 月 30 日，我們第四季末的現金約為 2,470 萬美元，正如詹姆斯所提到的，我們正在採取措施進一步減少營運費用，以擴大我們的現金跑道。

Operator, we can now please open the call for questions.

接線員，我們現在可以撥打電話詢問問題。

(Operator Instructions).

（操作員說明）。

Daniel Arias, Stifel.

丹尼爾·阿里亞斯，斯蒂菲爾。

Thanks for taking the questions. It's Paul on for Dan here. Just wondering about the sequential cadence looking forward into 2024 fiscal. So could you give some color on what you're looking for in Q1 out of Q4 and and from there, you know, how does that play out through the year?

感謝您提出問題。保羅代替丹出場。只是想知道 2024 財年的連續節奏。那麼，您能否說明一下您在第一季或第四季中尋找的內容，然後，您知道，這一年的情況如何？

OJ, do you want to answer that?

OJ，你想回答這個問題嗎？

(multiple speakers)

（多個發言者）

Yes, that's fine. And so, we indicated in the RNS, or the press release, this morning that test volumes have stayed fairly consistent through the period and into this first quarter. Billable volumes -- billable portion of that -- just about half of our 1,200 or so quarterly testing volume, and I do expect that to increase over the course of the fiscal year, both as a function of higher volumes as well as higher percentage of billable testing among the tests that we do. Not giving specific guidance on a quarter-by-quarter basis yet at this time.

是的，沒關係。因此，我們在今天早上的 RNS（即新聞稿）中指出，測試量在整個時期和第一季都保持相當穩定。可計費數量——其中的可計費部分——大約占我們1,200 次左右的季度測試量的一半，我確實預計這一數量將在本財年中增加，這既是由於數量增加，也是因為測試百分比增加。目前尚未按季度給出具體指引。

Sure, sure -- and then just for the follow-up, in terms of the Wake Forest EHR integration that you're working on, do you see a big inflection point in terms of how that cadence will roll out over the year? Or is that more of a -- you can start scaling some volumes before that's fully integrated and it will be a little smoother?

當然，當然——然後就後續行動而言，就您正在進行的維克森林電子病歷整合而言，您是否認為這一節奏將在一年內推出的一個重大拐點？或者這更像是——您可以在完全整合之前開始縮放一些卷，並且會更平滑一些？

So we've been working with Wake Forest for a while, and things are going quite well. There are a lot of physicians using KidneyIntelX at the moment. We're switching that over to a commercial model later this year. The integration into a major system like Atrium Wake Forest through Epic is a key proof point for us.

我們與維克森林大學合作已經有一段時間了，一切進展順利。目前有很多醫生在使用 KidneyIntelX。我們將在今年稍後將其轉變為商業模式。透過 Epic 整合到像 Atrium Wake Forest 這樣的主要係統對我們來說是一個關鍵的證明點。

We've already done that Mount Sinai. Everybody's asking, okay, that's great with Mount Sinai, let's see it in another large system -- well, this is it. So Wake Forest Atrium is quite large -- larger than Mount Sinai -- and having KidneyIntelX fully integrated into Epic and available for many practicing physicians now to order online is going to be a key milestone for us.

我們已經完成了西奈山的任務。每個人都在問，好吧，西奈山很棒，讓我們在另一個大型系統中看看它 - 好吧，就是這樣。因此，維克森林中庭相當大，比西奈山還大，而將 KidneyIntelX 完全整合到 Epic 中並可供許多執業醫生在線訂購，這對我們來說將是一個重要的里程碑。

And being able to do this with an independent Epic integration -- so we're doing this directly in conjunction with Wake Forest IT group -- it's been a tremendously successful process. We've learned an awful lot since we first did this with Mount Sinai. And I do very much believe in fiscal 2024, it's going to start to produce evidence of increased testing use, and I'm very excited to see this system come online.

能夠透過獨立的 Epic 整合來做到這一點——所以我們直接與維克森林 IT 團隊合作——這是一個非常成功的過程。自從我們第一次在西奈山做這件事以來，我們學到了很多。我非常相信 2024 財年，它將開始產生測試使用增加的證據，我很高興看到這個系統上線。

I do believe that with a fully integrated KidneyIntelX in Epic -- in a system like Atrium Wake Forest -- you now open up the possibility for practice alerts to come out. Especially now that we've passed through all of these significant milestones -- from outcomes data, the utility data, to FDA, inclusion in the draft guidelines, expansive reimbursement -- all of these milestones collectively add up to something that a large healthcare system can feel quite confident that KidneyIntelX should be part of standard of practice, and should be something that should be broadly used across their primary care physician networks to be able to understand risk and diabetes and kidney disease and help mitigate outcomes and also cost.

我確實相信，透過 Epic 中完全整合的 KidneyIntelX（在 Atrium Wake Forest 這樣的系統中），您現在可以打開練習警報的可能性。特別是現在我們已經經歷了所有這些重要的里程碑——從結果數據、效用數據到 FDA、納入指南草案、擴大報銷範圍——所有這些里程碑共同構成了一個大型醫療保健系統可以非常有信心KidneyIntelX 應該成為實踐標準的一部分，並且應該在其初級保健醫生網絡中廣泛使用，以便能夠了解風險以及糖尿病和腎臟疾病，並幫助減輕結果和成本。

So, the Wake Forest Atrium deployment, for us, is a very high priority and everyone should stay tuned. We'll have more news on that coming up shortly.

因此，對我們來說，維克森林中庭的部署是一個非常重要的優先事項，每個人都應該保持專注。我們很快就會有更多相關消息。

Great. That's helpful. Thank you. And congrats on all the progress.

偉大的。這很有幫助。謝謝。並祝賀所有的進展。

Thank you.

謝謝。

(Operator Instructions).

（操作員說明）。

Chris Glasper, Singer Capital Markets.

克里斯·格拉斯珀（Chris Glasper），辛格資本市場。

Yeah, morning, guys. Just a couple of questions, please. Firstly, can you just give us a little bit more color on the target penetration that you've outlined? I'm assuming that's cumulative over three years? And then second question, really, just again, quantifying a little bit of detail around the further cost savings that you're expecting to make? Thanks.

是的，早上好，夥計們。請教幾個問題。首先，您能否為我們介紹一下您所概述的目標滲透率？我假設這是三年來的累積？然後是第二個問題，真的，再一次，量化您期望進一步節省成本的一些細節？謝謝。

Yes, I will start with the cost savings, and OJ, please comment on top of me. You know, market conditions are fabulous -- as everybody knows -- and market volatility is high. This is not an easy environment. So we're taking cost reduction very seriously. We've already started to take specific steps so that we can lower our quarterly burn rate. We do not want to compromise our revenue generating capacity, so it's really a focus and a shift of priorities with a very heavy weight towards commercialization -- which is which is good and appropriate at this stage of the company now that we're on the other side of FDA.

是的，我將從節省成本開始，OJ，請在我上面發表評論。你知道，眾所周知，市場狀況非常好，而且市場波動性很大。這不是一個輕鬆的環境。因此，我們非常重視降低成本。我們已經開始採取具體措施，以便降低季度資金消耗率。我們不想損害我們的創收能力，所以這確實是一個重點和優先事項的轉變，非常重視商業化——這在公司現階段是好的和合適的，因為我們正處於FDA 的另一面。

So, we will continue to look for ways to narrow that burn rate. Obviously, other ways that you can narrow the burn rate is to increase the revenue, and we're working on that as well, specifically with the introduction of the direct-to-physician sales force. We talked about Atrium Wake Forest. There are other things in the pipeline that will give us additional exposure in select regions, so we're really focused now in select regions where we have high rates of diabetes and high rates of kidney disease and high rates of insurance coverage for KidneyIntelX, so these are optimal areas for us to expand and grow now. So, it's really a focusing of the of the company at the right time, at the right place, and we'll continue to look for ways to optimize cash use as we go forward -- but obviously, we're taking cash burn rate very seriously.

因此，我們將繼續尋找降低燒錢率的方法。顯然，減少燒錢率的其他方法是增加收入，我們也在努力解決這個問題，特別是引入直接面向醫生的銷售團隊。我們談論了 Atrium Wake Forest。醞釀中的其他項目將使我們在選定的地區獲得更多的曝光度，因此我們現在真正關注的是糖尿病發病率高、腎病發病率高以及 KidneyIntelX 保險覆蓋率高的選定地區，因此這些是我們現在擴張和發展的最佳領域。因此，這確實是公司在正確的時間、正確的地點重點關注的問題，我們將繼續尋找優化現金使用的方法，但顯然，我們正在考慮現金消耗率非常認真。

And I'm sorry, I lost the first part of your question. I was focused on the cash burn rate, what was your -- what was the first part?

很抱歉，我丟失了你問題的第一部分。我關注的是現金消耗率，你的第一部分是什麼？

Just around the 1% target penetration rate within three years?

三年內滲透率目標在 1% 左右嗎？

Yeah, I -- we've discussed this heavily internally. We've looked at historical examples of companies that have been successful and what their growth rates are. Once they have reached the threshold of crossing through reimbursement, regulatory outcomes data, they're starting to be included in the guidelines, what is a realistic way to look at business growth? And we've modeled what I think is an achievable target, which is a 1% penetration in our FDA-authorized use -- that's 14 million patients over the next three years.

是的，我們內部對此進行了深入討論。我們研究了歷史上成功公司的例子以及它們的成長率。一旦它們達到了報銷、監管結果數據的門檻，它們就開始被納入指南中，看待業務成長的現實方法是什麼？我們已經模擬了我認為可以實現的目標，即在 FDA 授權的使用中滲透率為 1%，即未來​​三年將覆蓋 1400 萬患者。

Exactly how that's going to roll out? Let's see, but I think that that is very realistic given the value proposition of KidneyIntelX, and given the fact that we are achieving and exceeding our own targets for comprehensive insurance coverage across the spectrum. Again, we have to stay focused early on, but this is a model that can now be scaled with the addition of additional hospital systems, depending on where the capital markets are and how we can invest properly in expanding salesforce, but we're all doing this on an ROI basis.

具體將如何推出？讓我們看看，但我認為，考慮到 KidneyIntelX 的價值主張，以及我們正在實現並超越我們自己的全面保險覆蓋目標的事實，這是非常現實的。同樣，我們必須儘早關注，但這是一個現在可以透過添加額外的醫院系統來擴展的模型，具體取決於資本市場的位置以及我們如何正確投資於擴大銷售隊伍，但我們都在投資回報率的基礎上做到這一點。

So we want to start to see now -- very much -- return on investment for capital invested in specific regions that become productive. And as they become productive, we can now look at expanding to additional regions where we have high insurance coverage, but the 1% target over the next three years I think is a very realistic goal, especially because KidneyIntelX is the only game in town. There is no other early stage AI-enabled prognostic with regulatory authorization and comprehensive reimbursement, so we view this as our market to establish a new standard, and we've done all of the hard work to put ourselves in this position.

因此，我們現在非常希望看到投資於具有生產力的特定地區的資本的投資回報。隨著它們變得富有成效，我們現在可以考慮擴展到其他擁有高保險覆蓋率的地區，但我認為未來三年1% 的目標是一個非常現實的目標，特別是因為KidneyIntelX 是城裡唯一的遊戲。沒有其他早期階段的人工智慧預測具有監管授權和全面報銷，因此我們認為這是我們建立新標準的市場，並且我們已經做了所有艱苦的工作來使自己處於這個位置。

So, that's where we came up with the number, and it's not without precedent. So we're looking back at other historical -- again -- historic examples of diagnostic services and products that have reached these key points of de-risking across multiple milestones.

所以，這就是我們得出這個數字的地方，這並非沒有先例。因此，我們再次回顧其他歷史性的診斷服務和產品的歷史範例，這些服務和產品已經達到了跨越多個里程碑的去風險關鍵點。

Understood. Thanks very much.

明白了。非常感謝。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, guys. Thanks for taking the questions and congrats on the milestones achieved in the in the calendar year. The first question I have -- so obviously you obtained FDA approval for KidneyIntelX.dkd. In the press release, you noted that the DKD, or the FDA-approved version has not yet been launched. Can you maybe clarify when you expect to launch the FDA-cleared version? And mechanically, like, what needs to happen? Is it the label? Is it messaging -- marketing? It would be helpful to learn what's needed to go ahead and commercially launch the FDA-cleared version.

大家好。感謝您提出問題，並祝賀您在本日曆年中取得的里程碑。我的第一個問題——很明顯，您獲得了 FDA 對 KidneyIntelX.dkd 的批准。在新聞稿中，您指出 DKD 或 FDA 批准的版本尚未推出。您能否澄清一下您預計何時推出 FDA 批准的版本？從機械角度來說，需要發生什麼？是標籤嗎？是訊息傳遞——行銷嗎？了解繼續推進 FDA 批准的版本並將其商業化所需的條件將很有幫助。

Yes, thank you. It's a very important point. And KidneyIntelX.dkd and KidneyIntelX -- we view is effectively the same product or the same service: same biomarkers; same laboratory procedures. But you do have to -- for example -- build reimbursement around KidneyIntelX.dkd. We are doing that successfully right now, so one of the key points is we need to make sure that we have Medicare payment established for KidneyIntelX.dkd. All of the sales literature and educational literature needs to conform with now regulatory-regulated language. The sales force needs to be trained specifically on that language.

是的，謝謝。這是非常重要的一點。 KidneyIntelX.dkd 和 KidneyIntelX — 我們認為實際上是相同的產品或相同的服務：相同的生物標記；相同的實驗室程序。但你確實必須——例如——圍繞 KidneyIntelX.dkd 建立報銷。我們現在正在成功做到這一點，因此關鍵點之一是我們需要確保為 KidneyIntelX.dkd 建立 Medicare 付款。所有銷售宣傳資料和教育宣傳資料都需要符合目前監管規定的語言。銷售人員需要接受該語言的專門培訓。

In terms of some of the integrations we've done, we also have to shift -- again -- to the specific regulated language around KidneyIntelX.dkd in the electronic medical records system. So, it's not trivial, but it is a process we're familiar with, and we have a lot of expertise, and we've been just putting one foot from the other. So, we'll be in a position to actually launch the FDA product -- the FDA service, actually -- most likely sometime early in the March quarter of this year.

就我們已經完成的一些整合而言，我們還必須再次轉向電子病歷系統中 KidneyIntelX.dkd 周圍的特定監管語言。所以，這並不是一件小事，但這是一個我們熟悉的過程，我們有很多專業知識，而且我們只是踏出了一步。因此，我們將能夠真正推出 FDA 產品——實際上是 FDA 服務——最有可能在今年三季初的某個時間。

Tom, I don't know -- are you connected at this point because you may want to amplify some of that.

湯姆，我不知道——此時您是否已連接，因為您可能想放大其中的一些內容。

Yes. I am here, James.

是的。我在這裡，詹姆斯。

That's good because I'm going to go hoarse taking over both sides of the script. (multiple speakers)

這很好，因為接手劇本的兩邊我都會變得沙啞。 （多個發言者）

Yeah, do you have any any additional commentary on Mark's question on the availability of KidneyIntelX.dkd and the process to put out the FDA service?

是的，您對 Mark 關於 KidneyIntelX.dkd 的可用性以及提供 FDA 服務的流程的問題還有其他評論嗎？

Yes. So, the timing of the launch is driven by the Medicare process which will be completed with the price effective for 2024, and on the process updates, the marketing materials that are needed for the launch and everything required contractually is underway now, so that when the conversion to the FDA test happens, it will be simple and straightforward and accomplished on a date certain.

是的。因此，推出的時機是由 Medicare 流程決定的，該流程將以 2024 年有效的價格完成，並且在流程更新方面，推出所需的營銷材料以及合同所需的一切現在正在進行中，因此，當向FDA 測試的轉換將會發生，它將簡單明了，並在特定日期完成。

Excellent. That's great color. So you were also included in the draft KDIGO guidelines. Is it your expectation that you'll be in the final guidelines? Can we expect that roughly by the end of the calendar year 2023?

出色的。那顏色真棒。所以您也被納入 KDIGO 指南草案中。您是否期望自己會出現在最終指南中？我們能預計到 2023 年底嗎？

Yes, we can. We're very excited about that. And it is actually this quickly -- quite thrilling for us to be able to be included in such a prestigious guideline. I think this is either the 10-year or the 20-year revision on KDIGO? KDIGO is the leading guideline in the kidney space. It takes a lot of data generation, which we've invested heavily in, and certainly it doesn't hurt to have a full regulatory process behind you, so we think this is quite a significant event.

我們可以。我們對此感到非常興奮。事實上，我們能夠這麼快就被納入這樣一個享有盛譽的指南中，真是令人興奮不已。我認為這是KDIGO的10年或20年修訂版？ KDIGO 是腎臟領域的領先指南。這需要大量的數據生成，我們對此投入了大量資金，當然，擁有完整的監管流程也沒什麼壞處，所以我們認為這是一個非常重要的事件。

We also expect that there will be other guidelines of activities as well coming up -- hopefully in the near term, you can never tell -- and we say this with all humility, but the goal ultimately is to be included in multiple guidelines around the diabetes, kidney disease primary care framework. And obviously these are all independent committees doing independent evaluation work. You don't have any control over any of this.

我們也預計還會出現其他活動指南——希望在短期內，你永遠無法確定——我們非常謙虛地這麼說，但最終的目標是包含在圍繞糖尿病、腎臟疾病初級保健框架。顯然這些都是獨立委員會在做獨立評估工作。您對此沒有任何控制權。

But what you can do is produce evidence, and have third parties produce evidence in multiple categories. And there's no shortcut here, and it's not cheap -- you have to produce real evidence from a health economic standpoint. You have to produce outcomes data. And as you know, outcomes data is now becoming a critical feature in reimbursement. In fact, I would go so far as to say, if you don't have outcomes data, you're going to have a tough time getting comprehensive reimbursement.

但你可以做的是提供證據，並讓第三方提供多個類別的證據。這裡沒有捷徑，而且也不便宜——你必須從健康經濟學的角度提供真實的證據。您必須產生結果資料。如您所知，結果資料現在正在成為報銷的關鍵特徵。事實上，我甚至想說，如果你沒有結果數據，你將很難獲得全面的報銷。

And generating outcomes data is a very special thing to do -- requires a lot of expertise -- especially in a chronic disease from an early stage where a lot of the outcomes endpoints take several years to become apparent. And then, of course, you need utility data. Are we changing behavior? Are we providing something that has benefit to -- in our case, really -- primary care? Because it is at the front end of medicine where you get the most preventative aspects.

產生結果數據是一件非常特殊的事情，需要大量的專業知識，尤其是在慢性疾病的早期階段，其中許多結果終點需要幾年的時間才能顯現出來。當然，您還需要公用事業數據。我們正在改變行為嗎？我們是否提供了對初級保健有益的東西——就我們而言，確實如此？因為在醫學的前端，您可以獲得最多的預防性知識。

So, we're really approaching kidney disease, for the first time, from a very early stage. At the front end of medicine -- where therapeutics had the most benefit; as little damage as done as possible to the organ; patients have better outcomes -- the costs can be reduced the most. If you wait until the patient progresses to late-stage disease -- which is a lot of what's happening right now in terms of uncontrolled progression -- you can't realize benefits in terms of outcomes, utility, and health economics.

所以，我們第一次真正從早期階段開始研究腎臟疾病。在醫學的前端－治療學最有益處；對器官造成的損害盡量小；患者有更好的結果—成本可以最大程度地降低。如果你等到患者進展到晚期疾病（這是目前正在發生的許多不受控制的進展的情況），你就無法實現結果、效用和健康經濟學方面的好處。

So, we're starting at the preventative medicine angle, and we're generating an enormous amount of data, and there are third parties that are now using KidneyIntelX across their networks that are also generating and publishing on outcomes and utility. These are the types of things that can help support guidelines committees to look for inclusion. So we're very happy.

因此，我們從預防醫學的角度開始，我們正在產生大量數據，現在有第三方在其網路上使用 KidneyIntelX，這些數據也在產生和發布結果和效用。這些類型的事情可以幫助支持指南委員會尋求包容性。所以我們很高興。

I don't -- I have never been able to achieve this many milestones this quickly in the product lifecycle in under five years. It's rare to see that done. And I think that that's really a testimony to the team that has designed a lot of these real-world evidence to show how KidneyIntelX can impact care in a number of ways and health economics in a number of ways.

我不——我從來沒有能夠在不到五年的時間內如此快地在產品生命週期中實現這麼多的里程碑。很少看到這樣做。我認為這確實是對團隊的證明，該團隊設計了許多現實世界的證據來展示 KidneyIntelX 如何以多種方式影響護理和健康經濟學。

So I'll stop there, but it's very exciting to be included in the draft guidelines. And yes, we do expect that the final guidelines will be published before the end of the year.

我就到此為止，但能夠被納入指南草案中是非常令人興奮的。是的，我們確實預計最終指南將在今年年底前發布。

Excellent. And then last question is a two-pronged one. You know, you had your CAC meeting -- I believe it was with NGS in New York. Can you just give us a procedural update of where we are in your quest to obtain an LCD from either NGS or, you know, one of the other local contracting MACs?

出色的。最後一個問題是一個雙管齊下的問題。您知道，您召開了 CAC 會議——我相信是在紐約與 NGS 舉行的會議。您能否向我們介紹一下我們在哪裡尋求從 NGS 或您知道的其他本地承包 MAC 之一獲取 LCD 的程序更新？

And also, you know, there have been other blockbuster diagnostics that have had FDA approval that have obtained national coverage determinations. Can you just give us maybe an update on -- just maybe reiterate -- do you still think that you're qualified to obtain an NCD? Is that a pathway you guys are pursuing? And also procedurally, what needs to happen there to get a sense of how achievable an NCD or LCD might be?

而且，您知道，還有其他重磅診斷產品已獲得 FDA 批准，並已獲得國家覆蓋範圍的確定。您能否向我們提供最新情況——也許只是重申一下——您仍然認為自己有資格獲得非傳染性疾病嗎？這是你們正在追求的道路嗎？從程式上來說，需要做什麼才能了解 NCD 或 LCD 的實現程度？

Yeah, very good questions. Tom, if you're connected, I'll let you take that one.

是的，非常好的問題。湯姆，如果你能接通，我就讓你接那個。

So, we need either a local coverage determination or a national coverage determination, and you've observed with Medicare, we're pursuing all pathways. With regard to National Government Services, which oversees or pays for any test samples that are run in our New York laboratory, they recently convened a CAC. panel meeting. It's -- as we said, external experts -- it's part of the LCD process, and when something is as innovative as KidneyIntelX, under 21st Century Cures, the contractor wants to make sure they make the clinical community aware of the evidence and seek their evaluation of the evidence as part of moving the LCD forward.

因此，我們需要確定本地承保範圍或確定全國承保範圍，您已經在醫療保險中觀察到，我們正在尋求所有途徑。至於國家政府服務部門，他們負責監督或支付在我們紐約實驗室運行的任何測試樣本的費用，他們最近舉行了一次 CAC。小組會議。正如我們所說，外部專家 - 它是 LCD 流程的一部分，當像 KidneyIntelX 這樣的創新產品在 21 世紀治癒下出現時，承包商希望確保他們讓臨床界了解證據並尋求他們的證據。的一部分，對證據進行評估。

As we said, we're very pleased with the outcome. In particular, as you know, KidneyIntelX is intended for use by primary care physicians and the community-based primary care doctor on the call spoke very highly of the value that this risk assessment would have on ability to deliver appropriate care for patients. NGS will now take that into consideration with what we believe was an important endorsement for the value of the test. They would draft the local coverage determination, review it with CMS -- which is required -- and then release that local coverage determination and hold an open meeting.

正如我們所說，我們對結果非常滿意。特別是，如您所知，KidneyIntelX 旨在供初級保健醫生使用，而通話中的社區初級保健醫生高度評價了這種風險評估對於為患者提供適當護理的能力的價值。 NGS 現在將考慮這一點，我們認為這是對測試價值的重要認可。他們將起草本地覆蓋範圍決定，與 CMS 一起審查（這是必需的），然後發布該本地覆蓋範圍決定並舉行公開會議。

So that is where we are in the cycle. We would expect it would be possible to see something early in calendar year 2024 based on the timing of the CAC meeting.

這就是我們所處的循環。我們預計，根據 CAC 會議的時間安排，有可能在 2024 年初看到一些進展。

With regard to other contractors, we do have a laboratory in Tampa, Florida, that is under the jurisdiction of First Coast, which has also been a contractor that pays for innovative diagnostics under individual claim review. We will submit initial claims to First Coast to begin that process, and we will also submit an application for a local coverage determination, and that it just gives us more support more opportunities to get local coverage determination adoption.

至於其他承包商，我們在佛羅裡達州坦帕市確實有一個實驗室，屬於第一海岸的管轄範圍，該實驗室也是根據個人索賠審查支付創新診斷費用的承包商。我們將向第一海岸提交初步索賠以開始該流程，我們還將提交一份當地覆蓋確定的申請，這只會為我們提供更多支持和更多機會來獲得當地覆蓋確定的採用。

At a national level, as you know, under breakthrough designation, there are some devices that are given parallel review. We have been under informal parallel review, which means that we have been working with CMS at a national level as we've gone through the FDA review process. As we came to the conclusion of the FDA review, we are able to submit for a national coverage determination.

如您所知，在國家層面，根據突破性指定，有一些設備受到並行審查。我們一直在接受非正式的平行審查，這意味著我們在完成 FDA 審查流程的同時，一直在國家層級與 CMS 合作。當我們得出 FDA 審查的結論時，我們可以提交全國覆蓋範圍的決定。

Typically with diagnostics, CMS looks to the local contractors to make those determinations, but after receiving FDA approval, we did meet with CMS and let them know of our intention to apply for an NCD. We will do the submission for that, we believe, within the next two to three weeks and wait to have feedback after they're able to review our dossier.

通常，對於診斷，CMS 會委託當地承包商做出這些決定，但在獲得 FDA 批准後，我們確實與 CMS 會面，並讓他們知道我們申請 NCD 的意圖。我們相信，我們將在接下來的兩到三週內提交相關資料，並等待他們審查我們的檔案後得到回饋。

And then we also continue to monitor on a new rule, which is TSAT, which would provide coverage to breakthrough devices that are FDA-approved. The industry hopes that that rule can be finalized by the end of 2023, and we would expect that KidneyIntelX would be eligible to also submit for a national coverage determination under that TSAT rule. Again, the important criteria there is that we are an FDA-approved, breakthrough designated device.

然後我們也繼續關註一項新規則，即 TSAT，它將為 FDA 批准的突破性設備提供保險。業界希望該規則能夠在 2023 年底之前最終確定，我們預計 KidneyIntelX 將有資格根據該 TSAT 規則提交全國覆蓋範圍確定。同樣，重要的標準是我們是 FDA 批准的突破性指定設備。

That's super helpful. There are quite a few avenues ahead of you, but thanks -- thanks so much for all the color.

這非常有幫助。你面前有很多途徑，但謝謝——非常感謝所有的顏色。

Thank you.

謝謝。

Jens Lindqvist, Investec.

Jens Lindqvist，天達集團。

Yeah, hi, guys. Just coming back to the KDIGO guidelines for a moment -- I assume you have seen at least part of the draft report. Now, can you share any color -- unless you've been sworn to silence by the KDIGO committee -- on the recommended positioning and use of KidneyIntelX in the revised guidelines? I mean, in terms of eligible patient groups, or potential repeat use, et cetera? And is this consistent with your own view on how to best deploy the test?

是的，嗨，夥計們。暫時回到 KDIGO 指南——我想您至少已經看到了報告草案的一部分。現在，您能否就修訂後的指南中建議的 KidneyIntelX 定位和使用分享任何意見（除非您已被 KDIGO 委員會發誓保持沉默）？我的意思是，就合格的患者群體或潛在的重複使用等而言？這與您自己關於如何最好地部署測試的觀點一致嗎？

And second, on the question raised earlier by Chris Glasper, can you be just a bit more specific on the out of the possible, please, with regards to cost reductions? You know, broadly, what proportion of OpEx would you say is realistically variable without jeopardizing the medium term performance of the business? Are we talking about single-digit, or potentially double-digit million over the current year?

其次，關於克里斯·格拉斯珀（Chris Glasper）早些時候提出的問題，您能否更具體地說明一下關於降低成本的可能性？您知道，從廣義上講，您認為營運支出的多少比例實際上是可變的，而不會損害企業的中期績效？我們談論的是今年的個位數百萬，還是潛在的兩位數百萬？

And then finally, for OJ, what's the reason for the unexpected increase in payables, please? How can we see that unwind over the coming couple of quarters? Thank you.

最後，請問OJ，應付帳款意外增加的原因是什麼？我們如何看待未來幾季的放鬆？謝謝。

Yeah, we want to be careful about commenting on the guidelines. I think it's important to recognize that KidneyIntelX.dkd is an in vitro diagnostic. That's very important. It's not an algorithm. It has an algorithm -- it happens to have a nonlinear algorithm -- we use Random forest, which is a machine learning-enabled algorithm. So it is unique, and it took us a long time to figure out how to navigate the regulatory framework with FDA around this nonlinear algorithm. That was quite an achievement.

是的，我們在評論指南時要小心。我認為認識到 KidneyIntelX.dkd 是一種體外診斷很重要。這非常重要。這不是一種演算法。它有一個演算法——它恰好有一個非線性演算法——我們使用隨機森林，這是一種支援機器學習的演算法。所以它是獨一無二的，我們花了很長時間才弄清楚如何圍繞這種非線性演算法與 FDA 合作管理監管框架。這是一項相當大的成就。

And we knew we needed to use that to generate the performance -- or the perspective -- if we were going to start at the beginning of a chronic disease. So, these are substantial innovations, and they required an enormous investment of time, data generation, and money, and expertise: all of which mean that KidneyIntelX is quite unique, especially in terms of positioning to your question in the clinical space.

我們知道，如果我們要從慢性疾病的初期開始，就需要利用它來產生績效或觀點。因此，這些都是實質的創新，需要投入大量的時間、數據生成、資金和專業知識：所有這些都意味著 KidneyIntelX 非常獨特，特別是在定位臨床領域的問題方面。

So, there are a number of innovations which go into an in vitro and artificial intelligence-enabled in vitro diagnostic with an FDA regulatory authorization. And then of course, we get into the whole issue of bringing in electronic medical record features, which many people are doing in algorithms, and it's interesting, but try running it through FDA. And that's a totally different validating process. And the level of validation required to get through a regulatory process when you're including electronic health record features with all the variables associated with that -- which I can't go into into the call -- but understanding how those variables impact the nonlinear algorithm output -- understanding this entire equation is very complicated.

因此，在獲得 FDA 監管授權的體外和人工智慧體外診斷方面有許多創新。當然，我們會討論引入電子病歷功能的整個問題，很多人正在演算法中做這件事，這很有趣，但請嘗試透過 FDA 運行它。這是一個完全不同的驗證過程。當您將電子健康記錄功能以及與之相關的所有變數納入時，請透過監管流程所需的驗證層級（我無法在通話中詳細說明），但請了解這些變數如何影響非線性演算法輸出—理解整個方程式非常複雜。

And obviously, if you can do it, it has significant advantages in terms of prediction -- and prediction from a very early stage of disease. So, there are a number of innovations that went into KidneyIntelX as a product service. We think that those will be pointed out or at least put us in a very distinct category in the guidelines.

顯然，如果你能做到這一點，它在預測方面以及從疾病的早期階段進行預測方面具有顯著的優勢。因此，KidneyIntelX 作為產品服務融入了許多創新。我們認為這些將在指南中被指出或至少將我們置於一個非常獨特的類別中。

And I'm not just speaking about KDIGO, I think there will be future guidelines available to us in different disease categories and different clinical categories because KidneyIntelX is so unique and it goes right to the heart of the matter. Which is, how do you predict risks early on in a chronic disease? A lot of it really hasn't been done before. Certainly not in a regulated format that's capable of being paid for broadly by insurance. And the level of validation required is enormous.

我不僅僅是在談論 KDIGO，我認為未來將會有不同疾病類別和不同臨床類別的指南可供我們使用，因為 KidneyIntelX 非常獨特，而且它直擊問題的核心。也就是說，如何在慢性病的早期預測風險？很多事情以前確實沒有做過。當然不是能夠透過保險廣泛支付的受監管格式。而且所需的驗證等級是巨大的。

And for us, the intrinsic value -- and having achieved this over a four year period with FDA -- again puts us in a unique position. And I think that that's going to pay dividends. In fact, we know it's going to pay dividends going forward because there's really no other way for -- you know -- the ability to do safe, reliable, and effective risk prognosis early on in a disease state regulated reimburse format. It's KidneyIntelX. And that requires years of investment and a lot of money, which we've been fortunate enough to be in a position to have -- so that we can invest in the real-world evidence, the outcomes data -- the validation required to do this, so the franchise value here we view is quite significant.

對我們來說，內在價值——以及在 FDA 的四年內實現的這一目標——再次使我們處於獨特的地位。我認為這將會帶來回報。事實上，我們知道它將在未來帶來紅利，因為確實沒有其他方法可以在疾病狀態監管的報銷格式中儘早進行安全、可靠和有效的風險預測。它是 KidneyIntelX。這需要多年的投資和大量的資金，我們很幸運能夠擁有這些資金——這樣我們就可以投資於現實世界的證據、結果數據——所需的驗證因此，我們認為這裡的特許經營價值是相當重要的。

I'll stop there. But OJ, you want to take on the out of the possible on the cost side?

我就到此為止。但是 OJ，您想在成本方面採取不可能的措施嗎？

Sure. And to start with the payables question, that's primarily a timing factor. There's an element of -- a good bit of that is clinical trial related payables. Those get invoiced in sizable chunks irregularly over the course of the year, so that comprises a bit of the payable growth there. As far as the further cuts, so we eliminated $11 million over that in the past year relative to the year prior. And further cuts available is likely -- we're likely looking at single-digit millions. I don't want to get into too much specifics -- we're still going through the detailed exercise of identifying where the cuts are and then are presenting that to the Board for approval and so forth. So subject to that approval -- don't want to get into much more detail, but that's probably the general quantum there.

當然。首先從應付帳款問題開始，這主要是一個時間因素。其中很大一部分是與臨床試驗相關的應付款項。這些費用在一年中不定期地大量開立發票，因此這構成了應付成長的一部分。至於進一步削減，去年我們比前一年削減了 1,100 萬美元。進一步的削減是有可能的——我們可能會考慮數百萬個位數。我不想透露太多細節——我們仍在進行詳細的工作，以確定削減的位置，然後將其提交給董事會批准等。因此，在獲得批准的情況下——不想了解更多細節，但這可能是那裡的一般量子。

Okay. Thanks guys -- very helpful. Thank you.

好的。謝謝你們——非常有幫助。謝謝。

(Operator Instructions).

（操作員說明）。

Yi Chen, H.C. Wainwright.

陳毅, H.C.溫賴特。

Thank you for taking my questions. My first question is, could you comment on the test volume in the health system versus Mount Sinai?

感謝您回答我的問題。我的第一個問題是，您能否評論一下衛生系統與西奈山的測試量？

So, Sinai still represents the majority of our overall volume, but it's getting closer to half -- whereas previously it was a higher percentage. Obviously when we started, it was almost entirely Mount Sinai for a while. So, seeing increases in independent primary care, as well as the Wake Forest Atrium testing continues to increase. None of that Atrium Wake Force testing is available yet, it's all study tests. We do -- as we've talked about -- we do expect that to transition to commercial testing over the course of this fiscal year. But Sinai -- just over -- a bit over half now -- the total volume.

因此，西奈半島仍然占我們總銷量的大部分，但它已經接近一半——而之前的比例更高。顯然，當我們開始時，有一段時間幾乎完全是西奈山。因此，獨立初級保健的增加以及維克森林中庭測試的持續增加。 Atrium Wake Force 測試尚未可用，這都是研究測試。正如我們所討論的，我們確實希望在本財年過渡到商業測試。但西奈半島——剛剛超過——現在略多於——總量的一半。

I mean, is there a specific reason, the VA health system is not generating high test volume?

我的意思是，退伍軍人事務部衛生系統沒有產生大量檢測量是否有具體原因？

And I -- I'll let Tom jump in as well. But -- oh, go ahead.

我——我也會讓湯姆加入進來。但是——哦，繼續吧。

I think there are lots of specific reasons. The VA system turned out to be substantially more complex than we could have imagined. We are still making progress with the VA system, but I think for us, we're resetting expectations around the VA as a business segment. I do think it will eventually become a significant contributor, but as we've said in previous calls, the complexity of operating inside the VA system, has been a bit of a surprise.

我認為有很多具體原因。事實證明，VA 系統比我們想像的要複雜得多。我們仍在 VA 系統方面取得進展，但我認為對我們來說，我們正在重新設定 VA 作為業務部門的期望。我確實認為它最終會成為一個重要的貢獻者，但正如我們在之前的電話中所說，VA 系統內部操作的複雜性有點令人驚訝。

Okay. So going forward, do you expect a steady growth in test volume from quarter to quarter, or do you think there will be variations and fluctuations?

好的。那麼，展望未來，您預期測試量會逐季穩定成長，還是會出現變化和波動？

Yes, yes, I am anticipating growth from there. Go ahead, James.

是的，是的，我期待從那裡開始成長。繼續吧，詹姆斯。

No, go ahead OJ, I apologize.

不，請繼續，OJ，我道歉。

No, that's the extent of it. So yes, it's been pretty steady state the last few quarters and into this quarter. We are expecting a growth from here -- for a lot of the reasons that we talked about on this call -- especially as we roll into the FDA version of the test later in this fiscal year. But that, combined with changes that we're also making on the sales and marketing fronts.

不，這就是它的範圍。所以是的，過去幾個季度和本季一直處於相當穩定的狀態。我們預計會從這裡開始成長——出於我們在這次電話會議上討論的許多原因——特別是當我們在本財年晚些時候推出 FDA 版本的測試時。但這與我們在銷售和行銷方面所做的改變相結合。

Okay. Thank you.

好的。謝謝。

(Operator Instructions).

（操作員說明）。

I show no further questions at this time. This concludes today's conference call. Thank you for participating. Have a great day. You may now disconnect.

我目前沒有提出任何進一步的問題。今天的電話會議到此結束。感謝您的參與。祝你有美好的一天。您現在可以斷開連線。