Renalytix PLC (RNLX) 2024 Q3 法說會逐字稿

Good morning and welcome to the Renalytix conference call to review its third quarter fiscal year 2024 financial results. (Operator Instructions) 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.

早安，歡迎參加 Renalytix 電話會議，回顧其 2024 財年第三季的財務表現。（操作員指示）提醒一下，此通話將被錄音以供重播。現在，我想將電話轉給 CapComm Partners 的 Peter DeNardo，請他作一些介紹性評論。

Thank you, Olivia. Thank you all for participating in today's call. Joining me today for Renalytix to provide formal remarks are James McCullough, Chief Executive Officer; and James Sterling, Chief Financial Officer; and Howard Doran, President is on hand for our question-and-answer session.

謝謝你，奧莉維亞。感謝大家參加今天的電話會議。今天與我一起為 Renalytix 發表正式講話的還有首席執行官 James McCullough；以及首席財務官詹姆斯·斯特林（James Sterling）；總裁霍華德·多蘭 (Howard Doran) 也將出席我們的問答環節。

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 events, results or performance are forward-looking statements. 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 costs 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 regarding product development, strategic partnerships and collaborations, reimbursement decisions, clinical studies, our regulatory submissions, our business strategies and future growth, including plans, expectations and opportunities for financing operations and revenue projections and guidance. 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 on September 28, 2023 for the Securities and Exchange Commission.

在我們開始之前，我想提醒您，管理階層將在本次電話會議中發表聲明，其中包括《1995 年私人證券訴訟改革法案》所定義的前瞻性聲明。本次電話會議中所做的任何與未來事件、結果或表現的預期或預測相關的陳述均為前瞻性陳述。這些聲明的範例包括但不限於潛在利益，包括 KidneyIntelX 的經濟節約、KidneyIntelX 的商業前景，包括 KidneyIntelX 是否會被醫生成功採用並分發和營銷、我們對報銷決策的期望以及 KidneyIntelX 降低慢性和終末期腎病成本的能力、優化護理服務和改善患者結果、我們對政府的利益決策、臨床研究、我們的監管提交、我們的業務策略和未來成長的期望，包括融資營運的計劃、期望和機會以及收入預測和指導。這些聲明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聲明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聲明。有關與我們的業務相關的風險和不確定性的描述，請參閱我們於 2023 年 9 月 28 日向美國證券交易委員會提交的 10-K 表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, May 15, 2024. All note that due to regulatory restrictions under the UK takeover code, when we can and cannot share at this time about the formal sales process, we are limited in the comments and information we can provide today. But suffice it to say that if there is material news to disclose about any developments, we will provide updates transparently as required. 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目前的估計和各種假設。Renalytix 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性聲明，無論是由於新資訊、未來事件或其他原因。本次電話會議包含時間敏感訊息，僅截至今天（2024 年 5 月 15 日）的現場直播時準確。請注意，由於英國收購法規的監管限制，我們目前可以和不能分享有關正式銷售流程的信息，因此我們今天可以提供的評論和信息有限。但可以說的是，如果有關於任何進展的重要新聞需要披露，我們將按要求透明地提供更新。現在我將電話轉給詹姆斯·麥卡洛。詹姆斯？

Thank you, Peter. Good morning, good afternoon. We have experienced a productive beginning to the 2024 calendar year. on February 8, Medicare contractor National Government Services issued a draft local coverage determination or LCD for KidneyIntelX. This follows an over three-year process, including two public hearings, submission of extensive outcomes, utility and regulatory data, and a significant volume of claims submitted to Medicare, which have now been reimbursed. We expect a final coverage determination to be issued in the near term.

謝謝你，彼得。早安，下午好。2024年，我們迎來了碩果累累的開端。 2 月 8 日，醫療保險承包商國家政府服務部發布了針對 KidneyIntelX 的本地覆蓋範圍決定或 LCD 草案。這項程序歷時三年多，包括兩次公開聽證會、提交大量結果、實用性和監管數據，以及向醫療保險提交大量索賠，這些索賠現已得到報銷。我們預計最終的覆蓋範圍決定將在近期發布。

On March 14, KidneyIntelX was included in the final international clinical guidelines for chronic kidney disease, known as KDIGO. Guidelines are followed by doctors, hospitals, and insurance payers throughout the world and are a critical milestone for establishing broad use of an advanced diagnostic tool such as KidneyIntelX. Also in March, we disclosed the formal sale process for the company after receiving an approach from a large, well-capitalized diagnostics company. Since this approach, additional potential acquirers have now joined in the discussions. While restricted on what we're able to say, we expect the sale process to be competitive, given our substantial regulatory outcomes, data, and reimbursement achievements and now the inclusion of KidneyIntelX in clinical guidelines.

3月14日，KidneyIntelX被納入慢性腎臟病最終國際臨床指引（KDIGO）。世界各地的醫生、醫院和保險支付者都遵循該指南，這是廣泛使用 KidneyIntelX 等先進診斷工具的關鍵里程碑。此外，在三月份，在收到一家大型、資金雄厚的診斷公司的接洽後，我們披露了公司的正式出售流程。自採取此方式以來，更多潛在收購者已加入討論。雖然我們能說的內容有限，但考慮到我們大量的監管結果、數據和報銷成就，以及現在將 KidneyIntelX 納入臨床指南，我們預計銷售過程將是具有競爭力的。

In March and April, we completed a common stock equity financing rounds, which extended our runway and provide us with further optionality to maximize shareholder value, whether as a stand-alone business entity or as part of a bigger business enterprise. In April, we officially launched our FDA authorized kidneyintelX.dkd product version and are now receiving commercial test orders. This will rapidly supplant the original KidneyIntelX laboratory developed test or LDT. kidneyintelX.dkd pricing remains the same at $950 per test, and we have established broad insurance reimbursement on a distinct CPT code for kidneyintelX.dkd in the clinical lab fee schedule.

三月和四月，我們完成了一輪普通股股權融資，這延長了我們的發展空間，並為我們提供了進一步的選擇權，以最大化股東價值，無論是作為獨立的商業實體還是作為大型商業企業的一部分。今年4月，我們正式推出了FDA授權的kidintelX.dkd產品版本，目前正在接受商業測試訂單。這將迅速取代原KidneyIntelX實驗室開發的測試或LDT。 kidneyintelX.dkd 的定價保持不變，仍為每次測試 950 美元，並且我們在臨床實驗室費用表中為 kidneyintelX.dkd 的不同 CPT 代碼建立了廣泛的保險報銷。

We have been steadily reorganizing the company through expense reduction and a hard turn to focus on sales growth, culminating with the appointment of Howard Doran to the position of President at the end of April. Difficult changes were made to conserve cash by optimizing our organization on sales with a year over year head count reduction of 50% and an overall OpEx reduction of approximately 40% year over year. That is close to a 60% overall expense reduction from peak, and we continue to look at near-term options for further expense reduction without impairing our ability to grow revenue.

我們一直在透過削減開支和全力轉向專注於銷售成長來穩步重組公司，最終在 4 月底任命 Howard Doran 為總裁。我們做出了艱難的改變來節省現金，透過優化銷售組織，員工人數年減 50%，整體營運支出較去年同期減少約 40%。與高峰相比，這相當於整體費用減少了近 60%，我們將繼續尋找近期進一步削減費用的選擇，同時不損害我們增加收入的能力。

Renalytix has now become a sales and marketing play into a wide-open market with 14 million diabetic kidney disease patients in the United States. The global population of diabetic kidney disease patients is much larger with many companies now reaching epidemic disease levels. We are in discussions with potential international distribution partners to reach these patients now that KidneyIntelX is FDA authorized and in the international clinical guidelines.

Renalytix 現在已成為美國一個擁有 1400 萬糖尿病腎病患者的廣大市場的銷售和行銷機構。全球糖尿病腎病變患者數量日益龐大，許多公司目前已達到流行病的水平。鑑於 KidneyIntelX 已獲得 FDA 授權並符合國際臨床指南，我們正在與潛在的國際分銷合作夥伴討論如何接觸這些患者。

Towards the end of 2023. We hired and trained a small direct to physician sales force in the United States, which has just completed the first full quarter of operations in March. The sales force is composed of experienced performers in the diagnostic industry, and I am pleased to report that we are already seeing a change in the breadth and volume of individual physician test ordering. The new sales force has achieved a 33% increase in direct to primary care test order rates quarter over quarter, a growth [10], which while early we are seeing continuing into the current fourth fiscal quarter.

接近 2023 年底。我們在美國僱用並培訓了一支小型直接面向醫生的銷售隊伍，該隊伍於 3 月剛完成第一個完整季度的營運。銷售團隊由診斷行業經驗豐富的人員組成，我很高興地報告，我們已經看到個人醫生測試訂購的廣度和數量發生了變化。新的銷售團隊實現了初級保健直接檢測訂單率環比增長 33%，這一增長 [10] 雖然還為時過早，但我們預計這一增長將持續到當前的第四財季。

In calendar 2024, we have implemented a series of ordering process improvements around the FDA product launch, which took place in April. Specifically, we have improved our customer facing offering to ease physician ordering and increase patient access to blood draws services. Our market focus is on a limited number of territories such as New York, where there are large populations of patients with diabetes and kidney disease and where we have achieved comprehensive insurance coverage for KidneyIntelX. These territories pose the best near-term opportunities to foster adoption of KidneyIntelX while accelerating test sales. We believe the FDA authorization in combination with a local coverage determination if and when issued and clinical guidelines inclusion, makes KidneyIntelX the only choice for preventative precision medicine prognosis in this large chronic disease population.

在 2024 年日曆中，我們圍繞 4 月的 FDA 產品發布實施了一系列訂購流程改進。具體來說，我們改進了面向客戶的服務，以方便醫生訂購並增加患者獲得抽血服務的機會。我們的市場重點是紐約等有限的地區，那裡有大量糖尿病和腎臟病患者，並且我們已經為KidneyIntelX實現了全面的保險覆蓋。這些地區為促進 KidneyIntelX 的採用和加速測試銷售提供了最佳的近期機會。我們相信，FDA 的授權加上當地覆蓋範圍的決定（如果發布）和臨床指南的納入，將使 KidneyIntelX 成為這一龐大慢性病族群預防精準醫學預後的唯一選擇。

Finally, we have received several questions regarding FDA's April 29 published final rule on laboratory-developed tests or LDTs. While we felt the final rule was more flexible than language proposed in the original drafting, it is clear that diagnostic testing is entering a new era of tighter regulation and exacting standards that will require everyone launching an advanced innovative test such as KidneyIntelX, to consider the significant capital investment and long timelines required for a full FDA review process.

最後，我們收到了幾個關於 FDA 4 月 29 日發布的實驗室開發測試或 LDT 最終規則的問題。雖然我們認為最終規則比原始起草中提出的語言更加靈活，但很明顯，診斷測試正在進入一個更嚴格的監管和嚴格標準的新時代，這將要求每個推出先進創新測試（如KidneyIntelX）的人都考慮全面 FDA 審查過程所需的大量資本投入和長期時間表。

By achieving FDA authorization for KidneyIntelX, this has increased the high barriers to entry around our business and technology. Particularly for diagnostic technologies that address very large markets such as chronic kidney disease and are capable of setting new clinical standards of care. We believe FDA regulation is becoming the default pathway to achieve comprehensive insurance reimbursement. Without regulation, it's very difficult to get paid in the future. We believe our decision to invest heavily upfront in real world outcomes data and a full FDA de novo review process were the right ones and add significantly to the franchise value of kidneyintelX.dkd and the KidneyIntelX artificial intelligence-enabled platform technology. I will now turn it over to James Sterling, our Chief Financial Officer. James?

透過獲得 KidneyIntelX 的 FDA 授權，這提高了我們業務和技術的進入門檻。特別是針對慢性腎臟病等非常大的市場並且能夠制定新的臨床護理標準的診斷技術。我們相信 FDA 監管正在成為實現全面保險報銷的預設途徑。如果沒有監管，將來就很難拿到薪水。我們相信，我們決定在前期對真實世界結果數據和完整的 FDA 從頭審查流程進行大量投資是正確的，並大大增加了 kidneyintelX.dkd 和 KidneyIntelX 人工智慧平台技術的特許經營價值。現在我將把話題交給我們的財務長詹姆斯‧斯特林 (James Sterling)。詹姆斯？

Thank you, James. Hello, everybody. Today, we issued the financial results for the third quarter of fiscal year 2024, which ended March 31. Our GAAP financials were filed today on Form 10-Q. Figures I will discuss here are based on our GAAP financials and quoted in US dollars, which is our reporting currency.

謝謝你，詹姆斯。大家好。今天，我們發布了截至3月31日的2024財年第三季的財務業績。我們的 GAAP 財務報表已於今日以 10-Q 表形式提交。我將在這裡討論的數字基於我們的 GAAP 財務數據並以美元（我們的報告貨幣）報價。

For the third quarter, we recorded revenue of $535,000 compared to $724,000 for the third quarter of the prior fiscal year. As a reminder, the prior year comparative period included tests that were performed under the original $6 million contract with Mount Sinai, which have since concluded. Testing at Mount Sinai has since been run under a standard commercial billing model. 806 tests were processed during the quarter, of which 82% were billable. Encouragingly, testing locations continue to diversify away from what had been largely dominated by a single hospital system with tests outside of Mount Sinai now accounting for nearly half of the total, up from about 30% 18 months ago.

第三季度，我們的營收為 53.5 萬美元，而去年同期的營收為 72.4 萬美元。提醒一下，去年同期的比較數據包括了根據與西奈山簽訂的最初 600 萬美元合約進行的測試，該合約目前已經結束。西奈山的測試一直按照標準商業計費模式進行。本季共處理了 806 項測試，其中 82％ 是可收費的。令人鼓舞的是，檢測地點持續多樣化，不再僅由單一醫院系統主導，西奈山以外的檢測現在佔總數的近一半，高於 18 個月前的 30% 左右。

As James stated, we're experiencing increasing test order velocity from our direct to physician sales force and expect the FDA de novo authorized version of the KidneyIntelX test to be onboarded with other health system providers in calendar 2024 following its official launch last month. Last quarter, we reported that NGS resumed consistent Medicare payment for tests under individual claims review, allowing revenue recognition in that quarter of 318 tests billed to Medicare, including 205 tests from earlier periods. Payment from NGS has continued on a consistent basis.

正如詹姆斯所說，我們從直接面向醫生的銷售團隊獲得的測試訂單速度正在不斷加快，我們預計，繼上個月正式推出之後，FDA 授權的 KidneyIntelX 測試版本將在 2024 年與其他醫療系統提供者合作。上個季度，我們報告稱，NGS 恢復了對個人索賠審查下的測試的一致醫療保險支付，從而允許在該季度確認向醫療保險收取的 318 項測試的收入，其中包括早期的 205 項測試。NGS 的付款一直持續進行。

Operating expenses for the third quarter were $6.5 million on a GAAP basis, down 40% from $11 million for the prior year period. This reflects the significant actions we took to lower operating expenses, including a 50% reduction in headcount as well as vendor spend reductions. Certain of these steps followed our FDA de novo authorization, which allows us to focus spend on the sales and marketing organization. Through these efforts, we have reduced our cash burn to under $5 million per quarter, which is 40% lower than the fiscal second quarter and half the level of a year ago.

根據 GAAP 計算，第三季營業費用為 650 萬美元，較去年同期的 1,100 萬美元下降 40%。這反映了我們為降低營運費用而採取的重大舉措，包括減少 50% 的員工人數以及減少供應商支出。其中一些步驟遵循了 FDA 的重新授權，這使我們能夠集中資金於銷售和行銷組織。透過這些努力，我們將每季的現金消耗減少到 500 萬美元以下，比第二財季降低了 40%，比去年同期降低了一半。

Net loss for the third quarter of fiscal 2024 was $7.7 million or $0.08 per share. This was down 36% from a net loss of about $12.1 million or $0.14 per share for the third quarter of fiscal 2023. We ended the third quarter with approximately $4.7 million in cash as of March 31. This does not include the approximately $6.4 million net proceeds from the second tranche of the March PIPE financing, nor the $1.5 million from the registered direct placement announced last month. We raised aggregate gross proceeds of $13.5 million in those financings. We continue to explore ways to carefully control operating costs without impairing our ability to grow test volumes and revenue. Operator, we can now please open the call for questions.

2024 財年第三季淨虧損為 770 萬美元，即每股 0.08 美元。這比 2023 財年第三季的淨虧損約 1,210 萬美元或每股 0.14 美元下降了 36%。截至 3 月 31 日，我們第三季結束時的現金約為 470 萬美元。這還不包括 3 月 PIPE 融資第二筆約 640 萬美元的淨收益，也不包括上個月宣布的註冊直接配售的 150 萬美元。我們在這些融資中籌集了總計 1,350 萬美元的總收益。我們將繼續探索在不損害我們增加測試量和收入的能力的情況下嚴格控制營運成本的方法。接線員，我們現在可以開始提問了。

(Operator Instructions) Dan Arias, Stifel.

（操作員說明）Dan Arias，Stifel。

Good morning, guys. Thank you. James, what's been the feedback from clinicians and payers on the guideline changes in the LCD? I mean, it seems like as much as anything else that's taken place for you guys. Those should be what moves the needle on test usage. So can you just talk to how you see the impact of those changes.

大家早安。謝謝。詹姆斯，臨床醫生和付款人對 LCD 指南的變化有何回饋？我的意思是，這看起來和你們身上發生的任何其他事情一樣多。這些應該是推動測試使用的因素。那麼您能談談您如何看待這些變化的影響嗎？

I'm sure the answer is they're going to be tremendously helpful, but what I'm really looking for is some discrete details on just where you expect to see the changes first, as a result, the extent to which they might change. And if they're not going to change, what the remaining sticking points might be for those folks in the FDA and at the stakeholder level? Thanks.

我確信答案是它們將會非常有幫助，但我真正尋找的是一些離散的細節，關於你期望首先看到變化的地方，以及它們可能變化的程度。如果他們不改變，那麼對於 FDA 和利害關係人而言，剩下的癥結是什麼？謝謝。

It's a very good question. Dan, good morning. We continuously update our communication with payers, including national payers. And obviously, we're in the final stages of LCD with the milestones and that includes obviously FDA, it includes updated outcomes data, it includes the draft LCD, which is a significant milestone and then of course, guidelines.

這是一個非常好的問題。丹，早安。我們不斷更新與付款人（包括國家付款人）的溝通。顯然，我們正處於 LCD 的最後階段，具有里程碑意義，其中顯然包括 FDA，包括更新的結果數據，包括 LCD 草案，這是一個重要的里程碑，當然還有指南。

So we've had a continuous stream of updates going out to the payer community. I'll give you one anecdote, we talked to the CMO of a major insurance plan who said, you know, LCD with guidelines, that's checkmate. So we expect that with the issuance of a final LCD, we've crossed the threshold for comprehensive payment throughout the United States. I can't see a reason why given the health economics data, the benefits of KidneyIntelX's third-party real-world usage of KidneyIntelX, which has now been published on outcomes.

因此，我們一直向付款人社群發布持續更新的資訊。我告訴你一個軼事，我們與一家大型保險計劃的首席營銷官進行了交談，他說，你知道，帶有指導方針的 LCD 就是將軍。因此，我們預計，隨著最終 LCD 的發布，我們已經跨越了全美全面支付的門檻。我看不出為什麼根據健康經濟學數據，KidneyIntelX 的第三方實際使用所帶來的好處已經公佈在成果上。

This thing makes a difference, not only in kidney health as measured by GFR slope, but also in diabetes as measured by HbA1c. So this is advanced preventative medicine. It works. It works very well for a variety of reasons. And it's working at a time when there are whole sequence of new drug therapies, which are quite expensive, including SGLT2 inhibitors, GLP-1 agonists.

這不僅對以 GFR 斜率衡量的腎臟健康有影響，而且對以 HbA1c 衡量的糖尿病也有影響。這是先進的預防醫學。有用。由於多種原因，它運作良好。目前，已有一系列新藥物療法問世，但這些療法相當昂貴，包括 SGLT2 抑制劑和 GLP-1 激動劑。

And how are you going to figure out which patients are at risk early on to be able to prescribe these drugs? So KidneyIntelX sits right at the heart of the whole health economics equation and precision medicine, which includes early identification, diagnosis, prognosis, therapeutic treatment, and really is the gateway to controlling costs and outcome. And that has been evidenced now extensively in outcome studies and that's one of the reasons we got put into the guidelines. So I do think we are very well positioned in calendar 2024 for comprehensive insurance coverage. And so far the feedback has been very good. There's never any guarantee, but we do feel that we're in a very good position.

那麼，您如何及早確定哪些患者有風險，從而能夠開立這些藥物呢？因此，KidneyIntelX 處於整個健康經濟方程式和精準醫療的核心位置，包括早期識別、診斷、預後、治療，是控製成本和結果的門戶。這已經在結果研究中得到廣泛證實，這也是我們被納入指引的原因之一。因此我確實認為我們在 2024 年已經做好了全面保險覆蓋的準備。到目前為止反饋非常好。雖然沒有任何保證，但我們確實覺得我們處於非常有利的地位。

And the other thing I'll point out, Dan, is we're doing this in a very short period of time. It's always difficult when you get here because people want to see sales ramp, people want to see building of the business. But the reality is that to be able to produce longitudinal outcomes data, get through a multiyear FDA de novo marketing process, get into the guidelines, and start commercial organization in five years is a very short timeline. So 2024 is going to be very interesting in terms of knocking through the rest of the insurance coverage.

丹，我要指出的另一件事是，我們是在很短的時間內完成這項工作的。當你來到這裡時總是會遇到困難，因為人們希望看到銷售額的成長，希望看到業務的建設。但現實情況是，要在五年內產生縱向結果數據、完成 FDA 多年的全新上市流程、獲得指南認可並啟動商業組織，這是一個非常短的時間範圍。因此，就打破其餘保險覆蓋範圍而言，2024 年將會非常有趣。

Okay. Yeah, I certainly hear you on five years being short and at the corporate level, as you can imagine, investors, less short-term investors that timeline is -- so I mean, to that point 800 tests during the quarter, which is down from 1,000 or so last quarter. I think that was down from 1,300 the prior quarter. Very simply when do you think we reverse trend and stay up on a test volume trajectory?

好的。是的，我當然聽到你說五年很短，在公司層面，你可以想像，投資者，短期投資者較少，這個時間表是--所以我的意思是，到那時為止，本季度進行了 800 次測試，比上一季度的 1,000 次左右有所下降。我認為這比上一季的 1,300 有所下降。很簡單，您認為什麼時候我們才能扭轉趨勢並保持測試量軌跡？

And along those lines to OJ's point on Mount Sinai volumes, volumes that aren't coming from Mount Sinai. Can you just talk about where we are with Wake Forest, St. Joe's, Utah, et cetera. Is there a point where just in aggregate those getting off the ground should start to be meaningful on a quarter-over-quarter basis? Thanks.

與 OJ 關於西奈山卷的觀點一致，這些卷不是來自西奈山。可以談談我們與維克森林大學、聖約瑟夫大學、猶他大學等等的現況嗎？整體而言，這些起步的數據是否應該在某個點上開始對季度環比產生意義？謝謝。

I think it's this year. And the reduction in total test volume is a function of us switching over to full commercial pay with Mount Sinai. This has been frustrating for me. Mount Sinai Health System is a fabulous partner. It is it is quite complex operating in that environment. That was our first launch customer. And we did that under a very specific environment with a defined contract to make the jump from that defined early-stage contract under IRB control to a proper commercial testing, it has been a challenge. We think that that is starting to work out now. And the interesting thing for me is we've now added the important optionality of growing direct to physician sales, and Howard will talk about that in a little bit. But the direct to physician sales is very much a bright light, and that is under our direct control.

我認為是今年。總測試量的減少是我們與西奈山轉換完全商業付費的結果。這讓我很沮喪。西奈山醫療系統是優秀的合作夥伴。在那種環境下操作是相當複雜的。那是我們的第一位啟動客戶。我們在一個非常特定的環境下透過明確的合約完成了這項工作，從 IRB 控制下的明確的早期合約轉向適當的商業測試，這是一個挑戰。我們認為現在這項措施已經開始見效了。對我來說有趣的是我們現在增加了直接向醫生銷售的重要可選性，霍華德稍後會談到這一點。但直接面對醫生的銷售非常亮眼，而且是在我們的直接控制之下。

We also do expect to be seeing value coming out of the Atrium Wake Forest launch. And we do expect to see other groups coming on board. And I'll make one statement. It's been quite a balancing act to reorganize the company. It's like flying an airplane, a slowdown and go down. Difficult to achieve. We're now getting through the final stages of that where we've substantially reduced the operating burn, reorganized the human resources platform, brought new people onboard like Howard, and a new sales force, which is now has one quarter under its belt. So I would expect that we're going to see a leveling off and an increase without forecasting in testing volume activity. And most importantly for me, the breadth of the testing volume activity. So we're not just totally dependent on Mount Sinai as a single source customer. And that took place in 2024.

我們也確實期待看到 Atrium Wake Forest 發表會帶來的價值。我們確實期望其他團體能夠加入。我要發表一個聲明。重組公司是一項相當艱難的平衡工作。這就像駕駛飛機一樣，速度會減速並下降。很難實現。現在，我們正處於最後階段，我們大幅減少了營運成本，重組了人力資源平台，引進了像霍華德這樣的新人才，並組建了一支新的銷售隊伍，目前這支銷售隊伍已經成立一個季度了。因此，我預計我們將看到測試量活動趨於平穩並出現成長，而無需進行預測。對我來說最重要的是測試量活動的廣度。因此，我們並不完全依賴西奈山作為單一客戶來源。這件事發生在2024年。

If I may, sorry to interrupt, if I may add James. The numbers, Dan, that you had listed were total tests, including non-billable study tests. And we have curtailed the study test quite a bit after the terrific data after the 12 months point and also was a great opportunity to save some money. If you looked at just the billable tests, the decline is a lot less dramatic than what you indicated, mainly flat more or less. And so I just want to make that important distinction. If you just look at billable tests, it's a much better picture.

如果可以的話，很抱歉打斷一下，如果我可以補充詹姆斯。丹，你列出的數字是總測驗數，包括不可收費的學習測驗。在獲得了 12 個月後的出色數據後，我們大大減少了研究測試，這也是節省金錢的好機會。如果你只看計費測試，下降幅度並沒有你所說的那麼大，主要是持平。所以我只想指出這個重要的區別。如果你只看可計費測試，情況就會好得多。

Okay. That's helpful. OJ, since you brought it up, James mentioned in a non-forecasting way that he thinks volumes should be able to ramp here in the coming quarters. In a forecasted way, would you agree with that?

好的。這很有幫助。OJ，既然你提到了這一點，詹姆斯以非預測的方式提到，他認為未來幾季的銷售應該可以增加。從預測的角度來說，您同意這一點嗎？

(laughter) Yes, I'll stick to a non-forecast way. But, yes, no, there's certainly a path for volumes to be increasing and the work that Howard is doing, particularly in the primary care, independent primary care side is pretty exciting. So it's a nice growth there.

（笑聲）是的，我會堅持非預測的方式。但是，是的，不是的，數量肯定有增加的途徑，霍華德所做的工作，特別是在初級保健、獨立初級保健方面，非常令人興奮。因此，這是一個很好的成長。

Okay. Thank you, guys.

好的。謝謝你們。

Randy Baron, Pinnacle Associates.

蘭迪‧巴倫 (Randy Baron)，Pinnacle Associates 公司。

Hi, good morning.

嗨，早安。

Can you guys hear me?

你們聽得到我的聲音嗎？

Yes, good morning, Randy.

是的，早上好，蘭迪。

Okay, I have a couple of administrative questions and then two broader ones. Just really quickly. It was encouraging, at least for me to hear that more bidders seem to have come out in this process since the initial unsolicited inbound in March that you got. Understanding the constraints that lawyers put on you. Is it fair to say that, that process potential acquisition is active and ongoing?

好的，我有幾個管理性問題，然後是兩個更廣泛的問題。真的很快。這令人鼓舞，至少對我來說，聽說自 3 月收到首批未經請求的投標以來，似乎有更多的投標人參與了這一過程。了解律師對您施加的限制。是否可以說潛在收購過程是主動且持續的？

So it is active, and we are restricted. So I won't comment specifically on the process. But I will say that it is not every day. In fact, it's quite rare that you find a product services like KidneyIntelX that addresses such a large market. In the case of the United States, it's about 14 million patients with diabetes and kidney disease. That's wide open. And that has a price attached to it of $950 per reportable result, which gives us a very significant margin, and which now has been de-risked on a regulatory front. We are largely derisking it on a reimbursement front and is now in the clinical guidelines. And again, the data, which is so important, which we've invested heavily in, which has allowed us to get insurance reimbursement and get into guidelines and get through FDA, is very good and affects not only kidney health but also diabetes health.

所以它是主動的，而我們受到限制。所以我不會具體評論這個過程。但我要說的是，這種情況並不是每天都有。事實上，很少能找到像 KidneyIntelX 一樣針對如此龐大市場的產品服務。就美國而言，約有1400萬名糖尿病和腎臟病患者。這太開放了。每個可報告結果的價格為 950 美元，這為我們帶來了非常可觀的利潤，而且目前監管方面的風險已經降低。我們在報銷方面已基本降低風險，目前已將其納入臨床指引。再說一次，數據非常重要，我們對此投入了大量資金，這些數據使我們能夠獲得保險報銷，獲得指導方針並通過 FDA 審核，這些數據非常好，不僅影響腎臟健康，還影響糖尿病健康。

So here, you have a singular product. And with the new look from FDA on laboratory-developed tests and the expense associated with doing this, the barriers to entry are very high for a blood-based biomarker driven artificial intelligence-enabled in vitro prognostic. So this really is the only precision medicine preventative solution at the front end of this huge disease funnel. And we are not surprised that, that would attract significant interest from multiple players, not just in the diagnostic industry. Obviously, we have to continue with our sales and marketing effort, and we want to increase optionality here, strategic partnering is an option, acquisition is an option, all of which allow us to address this significant market. But this is a product that is rare to find. So we're not surprised that this process would be competitive.

現在，您有一個獨特的產品。而且，隨著 FDA 對實驗室開發的測試及其相關費用的新看法，基於血液的生物標記驅動的人工智慧體外預後方法的進入門檻非常高。因此，這確實是這個巨大疾病漏斗前端唯一的精準醫療預防解決方案。我們並不感到驚訝，這將吸引多個參與者的極大興趣，而不僅僅是在診斷行業。顯然，我們必須繼續我們的銷售和行銷努力，並且我們希望在這裡增加可選性，策略合作是一種選擇，收購也是一種選擇，所有這些都使我們能夠解決這個重要的市場。但這是一種很難找到的產品。因此，我們對這過程的競爭性並不感到驚訝。

Great. And then, OJ, just an administrative question for you. You guys did a couple of -- a series of raises in the quarter. What's pro forma cash today?

偉大的。然後，OJ，我只想問你一個管理問題。你們在本季進行了幾次加薪。今天的預計現金是多少？

So we reported $4.7 million in cash on March 31. I don't want to -- I haven't in the past given a spot cash balance during this call. So I won't change that policy now. But $4.7 million of cash at March 31, and that does not include the $6.4 million from the second tranche of the PIPE, nor the $1.5 million from the registered direct. So the note on that $4.7 million figure was from 45 days ago. So that should arm you with enough information to do your estimate. But that's the detail that I can provide now.

因此我們報告 3 月 31 日的現金為 470 萬美元。我不想——過去我在這次通話中沒有提供現貨現金餘額。所以我現在不會改變這項政策。但 3 月 31 日的現金為 470 萬美元，這還不包括來自 PIPE 第二筆資金的 640 萬美元，也不包括來自註冊直接投資的 150 萬美元。因此，關於 470 萬美元的數字是 45 天前的。這樣你就可以獲得足夠的資訊來進行估算。但這就是我現在可以提供的細節。

Okay. And then just two really quick broad questions. Howard, I guess this is for you and James. It was interesting in the script to hear you talk about the breadth and volume of test changes at the direct to physician level. I missed the number, I think you said 30% or 33% growth. But can you just talk broadly about what you've done on sales and market activity? What did the reorganization to align on commercial activities do? How many salespeople do you have now, et cetera?

好的。接下來是兩個非常簡短、廣泛的問題。霍華德，我想這是給你和詹姆斯的。在劇本中聽您談論直接針對醫生的測試變化的廣度和數量是很有趣的。我記錯了數字，我想你說的是成長 30% 或 33%。但您能否大致談談您在銷售和市場活動方面所做的工作？此次重組對商業活動有何影響？您現在有多少名銷售人員等等？

Thanks for the question, Randy. Yes, so first and foremost, we pretty much have retooled the entire sales team from when it was last summer. We actually have four members of the team that actually were legacy that have been with us since between 2021 and 2022. We have three additional folks that are remaining from our training class that we had this past August. And we brought in three new folks as we discussed on the last call this December. So their first time in the field really was this January of this current quarter.

謝謝你的提問，蘭迪。是的，首先，我們從去年夏天開始就對整個銷售團隊進行了重組。實際上，我們團隊中有四名成員實際上是遺留人員，他們自 2021 年至 2022 年期間一直與我們在一起。我們有另外三名人員是去年八月訓練班的剩餘人員。正如我們在今年 12 月的上次電話會議上討論的那樣，我們引入了三名新員工。所以他們第一次進入該領域確實是在本季度的一月份。

So big change is just that the folks that we have. And just as we talked about on our last call, that these folks come with -- the new folks come with strong diagnostic background, half of that group comes with nephrology experience in their past. So they know that big practices, they're able to get into some of the key thought leaders, et cetera. And just the general nephrologists that are out practicing that are very supportive of our efforts, but also can also assist us with going out to the PCPs with their recommendation because they're part of the referral pattern. So having folks that can knock on those doors in addition is also helpful.

所以巨大的改變就在於我們擁有的人。正如我們在上次電話會議中談到的那樣，這些新人擁有強大的診斷背景，其中一半過去有腎臟病學經驗。所以他們知道，透過大型實踐，他們能夠接觸到一些關鍵的思想領袖等等。不僅外出執業的普通腎臟科醫生非常支持我們的努力，而且他們還可以協助我們向 PCP 提供推薦，因為他們是轉診模式的一部分。因此，擁有能夠敲開這些門的人也很有幫助。

We've taken a look at our marketing materials. And I just think one of the biggest triggers is having the one-year outcomes data that came during this period allowed us to really complete the story. We have a very -- we have a test that's very simple to understand what it does. Obviously, it gives you the low medium and high risks test results of the patient. But now the first question, the PCP or nephrologist for that matter was going to ask is, what do I do with this information? Is it actionable? And now that there's a lot more tools in the toolkit from a standpoint of what you can do therapeutic wise for these patients, there's a lot of choices. So clearly, we are seeing evidence in our outcome study where in the high-risk category for example, there was a 61% increase in patients that were being put on SGLT2s.

我們已經看過我們的行銷資料了。我認為，最大的觸發因素之一是這段期間獲得的一年期結果數據使我們能夠真正完成這個故事。我們有一個非常簡單的測試，可以理解它的作用。顯然，它給出了患者的低、中、高風險測試結果。但現在 PCP 或腎臟病專家要問的第一個問題是，我該如何處理這些資訊？它具有可操作性嗎？現在，從可以為這些患者提供治療的角度來看，工具包中已經有很多工具，因此有很多選擇。因此很明顯，我們在結果研究中看到證據表明，例如在高風險類別中，接受 SGLT2 治療的患者數量增加了 61%。

So we've answered the question is what does the tests do? Is it actionable? Yes. And then again, the third thing that we're highlighting in all of our materials, are what are the outcomes. And there's really five distinct things when you think about it that we're really highlighting and referencing right now. One is just are the clinical betterment of the patient is one is, James had mentioned a moment ago, GFR. So when GFR flattening of decline incurs, that means kidney function is being withheld or being -- the declining kidney function is actually more stabilized is what I mean by that, which means it extends the runway to potentially further negative outcomes. So it's a much, it's about a 50% reduction and a lowering of that GFR result that is causing that assistance.

所以我們已經回答了這個問題：測驗起什麼作用？它具有可操作性嗎？是的。再次，我們在所有材料中強調的第三件事是結果是什麼。如果你仔細想想，你會發現我們現在真正要強調和參考的其實有五件不同的事情。一個是病人的臨床改善，一個就是，詹姆斯剛才提到的，GFR。因此，當 GFR 趨於平穩或下降時，這意味著腎功能受到抑製或——我指的是下降的腎功能實際上更加穩定，這意味著它延長了潛在進一步負面結果的跑道。因此，這是一個很大的減少，大約是 50% 的減少，而 GFR 結果的降低導致了這種援助。

When you go to uACR, which is a measure of kidney damage. We're also seeing a reduction in uACR based on the medication. So kidney health in general, that progression of the disease is slowing. So that's very important. And then the three additional factors are all HEDIS measures. One is because we're doing uACR testing in the combination with our test, that's a HEDIS checkpoint. One third of patients in this study also saw a retreat in their blood pressure down to 140/90, back in normal range. That's a HEDIS function. And also lowering in A1C was seen statistically significant at our high risk and intermediate risk patients. That also was a HEDIS reduction.

當您轉到 uACR 時，它是腎臟損傷的衡量標準。我們也看到，根據藥物治療，uACR 有所降低。因此，就腎臟健康狀況而言，疾病的進展正在減緩。所以這非常重要。另外三個因素都是 HEDIS 措施。一是因為我們結合我們的測試進行 uACR 測試，這是一個 HEDIS 檢查點。本研究中三分之一的患者的血壓也下降至 140/90，恢復正常範圍。這是一個 HEDIS 功能。並且，我們的高風險和中度風險患者的 A1C 水準也呈現統計學顯著降低。這也是 HEDIS 的減少。

So there's three distinct quality measures associated with HEDIS as well as improvements in kidney health that are coming out of this outcome study. So that was really sort of the last piece of the story that we didn't have. And that's been incorporated in a much tighter, simpler message for the clinicians to understand. So I would say those are the two biggest variables, new team with broader experience, coupled with better data and a very streamlined approach on the advantages of kidneyintelX.dkd.

因此，該結果研究得出了與 HEDIS 相關的三個不同品質指標以及腎臟健康的改善。所以這實際上是我們所沒有的故事的最後一部分。這些資訊已融入更嚴謹、簡單的資訊中，方便臨床醫生理解。所以我想說這是兩個最大的變量，擁有更豐富經驗的新團隊，加上更好的數據和對 kidneyintelX.dkd 優勢的非常簡化的方法。

That's great, Howard. And then my last question and I'll go back in queue. Just I guess, James for you. Dan clearly touched on the importance of the LCD, it sounds like an event. To my knowledge when I looked, I didn't see any negative comments in the open comment period. So when do you expect finalization to happen and what are the implications?

太好了，霍華德。然後是我的最後一個問題，我將回到隊列中。我猜，詹姆斯就是你的最佳人選。丹清楚地談到了 LCD 的重要性，這聽起來像是一個事件。據我所知，我在開放評論期內沒有看到任何負面評論。那麼您預計最終確定何時發生以及其影響是什麼？

Yes. The National Government Services has until September to issue, that's the standard time frame. We could see it sooner than September. The implications are significant, especially in combination with guidelines. These processes are not easy at all. They take a long time. There's a lot of data production required, especially when you're innovating in an area where there's been nothing before you. So really prediction early of chronic disease risk is a difficult thing to do. And we saw this with FDA. The level of proof and validation required to get through these government organizations and to be able to declare a risk with accuracy early and do it in a way that it's simple for a primary care physician to interpret, even though there's a lot of technology back end. This requires a significant amount of validation, a lot of data, a lot of process.

是的。國家政府服務必須在九月之前發布，這是標準的時間範圍。我們可能在九月之前就看到它。其影響十分重大，尤其是與指導方針結合時。這些過程非常不容易。他們要花很長時間。需要產生大量的數據，尤其是當你在一個之前沒有過的領域進行創新時。因此，早期預測慢性病風險確實是一件困難的事。我們在 FDA 身上也看到了這一點。需要透過這些政府組織的證明和驗證水平，才能儘早準確地宣布風險，並以一種初級保健醫生容易理解的方式進行，儘管後端有很多技術問題。這需要大量的驗證、大量的數據和大量的流程。

Getting Medicare coverage into such a large population is going to be a major event for us, and not easy to replicate. And I think the comments I'm hearing I gave you one earlier on is, that you really enter a new paradigm when you are in the guidelines, and you've got this long-term Medicare coverage in place. And with the health economics data, with the clear advantage of KidneyIntelX in terms of preventative medicine, I don't see a case why an insurance company does not cover KidneyIntelX. And for progressive thinkers, I don't see a case why insurance companies don't educate physicians on the benefits of using KidneyIntelX. Everybody wins. The insurance company wins, the patient wins. Obviously, we will win. The government wins because they're spending an inordinate amount of money on patients that fall into dialysis, which published in JAMA last year, first year alone for dialysis cost, treatment for kidney failure is over $200,000 a year.

讓如此龐大的人口享受醫療保險對我們來說是一件大事，而且不容易複製。我認為我聽到的評論是，我之前給你的一條是，當你遵循指導方針時，你真的進入了一個新模式，並且你已經獲得了長期的醫療保險覆蓋。而且根據衛生經濟數據，鑑於 KidneyIntelX 在預防醫學方面的明顯優勢，我認為沒有理由保險公司不承保 KidneyIntelX。對於進步思想家來說，我認為保險公司沒有理由不教育醫生使用 KidneyIntelX 的好處。每個人都是贏家。保險公司贏了，病人也贏了。顯然，我們會勝利。政府獲益了，因為他們在需要透析的病人身上花費了過多的錢，據去年《美國醫學會雜誌》報道，僅第一年的透析費用、腎衰竭的治療費用就超過每年 20 萬美元。

And everything's a time and a place. We have the drugs now that are available. Insurance coverage, they have very good data. And pharma is now out educating with us on the importance of diagnosing kidney disease, especially if you have diabetes. So the equation now becomes very simple, right? It's if you have diabetes, you have to be diagnosed for kidney disease. Do you have it or don't you? And if you have diabetes and kidney disease, you have to understand your risk because we know the top 10% to 15% of patients at high risk by KidneyIntelX have a greater than two thirds chance of experiencing an event, significant decline in kidney function or kidney failure over the next couple of years. The bottom 50% of patients, regardless of stage and grade, you can be moderate stage kidney disease. But if you're at low risk by KidneyIntelX, you are highly unlikely to progress. So this is not a marginal equation. This is a very strong, to me black and white equation at the front end of this huge disease funnel. And we can now for the first time, rapidly and in an easy way for the primary care physician determine who should be treated and who's really at risk and who's not.

凡事都有其時間和地點。我們現在有可用的藥物。保險覆蓋範圍，他們有非常好的數據。現在製藥公司正在向我們宣傳診斷腎臟疾病的重要性，特別是對於患有糖尿病的患者。那麼這個等式現在變得非常簡單了，對嗎？如果您患有糖尿病，就必須診斷出患有腎臟疾病。你有還是沒有？如果您患有糖尿病和腎病，您必須了解自己的風險，因為我們知道，KidneyIntelX 列出的高風險患者中，排名前 10% 到 15% 的患者在未來幾年內出現腎功能顯著下降或腎衰竭的可能性超過三分之二。最底層的 50% 的患者，無論分期和等級如何，都可能屬於中度腎病。但如果您因 KidneyIntelX 而處於低風險狀態，那麼您病情進展的可能性就很小。所以這不是一個邊際方程式。對我來說，這是這個巨大疾病漏斗前端的一個非常強大的黑白方程式。現在，我們首次能夠讓初級保健醫生快速、輕鬆地確定哪些人應該接受治療、哪些人真正處於危險之中、哪些人沒有。

So everybody benefits with KidneyIntelX. And the payoff comes very quickly because the cost of not catching people early is so significant. So we can eliminate a whole lot of suffering across millions of patients and a whole lot of cost. This really is the paradigm for how you manage chronic disease. And not to go too much further. But this is the issue that we all face in clinical medicine going forward. How do we manage chronic disease? Because you can't treat everybody. Populations are too large. And if you don't have prognosis early, accurate early prognosis, accurate early risk assessment, you've already lost the war. And here we now have an FDA approved, beautiful outcomes in the guidelines. And now with an LCD, the equation is really complete. And we've achieved what should be now the standard of care around the world for early-stage prognosis in this big disease state. So I do think the LCD issuance is a key and critical validation and is going to help start to move the clinical community towards adoption.

因此，每個人都能從 KidneyIntelX 中受益。而且回報來得非常快，因為不及早發現的代價是如此之大。因此我們可以減輕數百萬患者的痛苦並節省大量成本。這確實是管理慢性病的範例。而且不要走太遠。但這是我們未來在臨床醫學領域面臨的問題。我們如何管理慢性病？因為你不可能治療所有人。人口太多了。如果你沒有早期預測、準確的早期預測和準確的早期風險評估，你就已經輸掉了這場戰爭。現在我們已經獲得了 FDA 的批准，該指南取得了令人滿意的結果。現在有了 LCD，這個等式才真正完整。我們已經達到了目前全球對這一重大疾病早期預測的治療標準。因此，我確實認為 LCD 的發布是一項關鍵且至關重要的驗證，並將有助於推動臨床界開始採用它。

That's great. Good luck.

那太棒了。祝你好運。

Mark Massaro, BTIG.

BTIG 的馬克馬薩羅。

Hey, Mark, we can't hear you. You may be on mute.

嘿，馬克，我們聽不到你的聲音。您可能處於靜音狀態。

Sorry about that. Can you hear me now?

很抱歉。現在你能聽到我的聲音嗎？

Yes, now we can hear you.

是的，現在我們可以聽到您的聲音了。

Okay. Yeah. Thanks for taking my questions. So you guys got into final KDIGO guidelines two months ago. And in the past, you've disclosed metrics like number of commercial payers, a number of Medicaid contracts, I think roughly 40 private payers and call it 35 state Medicaid contracts. Do you have an update on the payer coverage that you have today? And in the last couple of months, has there been any movement towards engaging payers in a greater capacity? And maybe could you just remind me who you have? Obviously, you've made some reductions in headcount, but do you have a team of folks in front of commercial payers at this time?

好的。是的。感謝您回答我的問題。所以你們兩個月前就已經進入了最終的 KDIGO 指南。過去，您曾披露過商業付款人數量、醫療補助合約數量等指標，我認為大約有 40 家私人付款人，以及 35 份州醫療補助合約。您對今天的付款人覆蓋範圍有什麼更新嗎？在過去的幾個月中，有沒有採取任何措施來讓付款人更參與？也許你能提醒我你是誰嗎？顯然，你們已經裁減了一些員工，但你們目前是否有一支專門負責商業付款人的團隊？

Yes. And I'll take that last question. The headcount reduction has obviously been painful. And we have ended up with what I think is an efficient market access group, which is the group that interacts with payers. We have also -- we have a third-party billing group that we've been working with for a while now, who has taken on more and more of the burden, administration burden because as you get more and more payer contracts, there's a larger administrative burden that goes along with maintaining those payer contracts. And so we've been able to find a more efficient mix there.

是的。我來回答最後一個問題。裁員顯然是痛苦的。我認為，我們最終組建了一個高效的市場准入團體，即與付款人互動的團體。我們還有一個第三方計費小組，我們已經與之合作了一段時間，該小組承擔了越來越多的負擔，管理負擔，因為隨著你獲得越來越多的付款人合同，維護這些付款人合同的管理負擔也會越來越大。因此我們能夠找到更有效的組合。

And again, as I said originally earlier on in the call, this is a dynamic process. I've learned an awful lot about how do you create comprehensive payer coverage? It's very difficult, right? Because you have different payers with different ideas of value-based care, different ideas of health economics, different drivers, there are early adopters, mid adopters, and late adopters, there national payers, there are local payers, there's Medicare Medicaid.

正如我早些時候在通話中所說的那樣，這是一個動態的過程。我學到了很多關於如何創建全面付款人覆蓋的知識。這很難，對吧？因為不同的付款人對基於價值的照護有不同的看法，對健康經濟學有不同的看法，有不同的驅動因素，所以有早期採用者、中期採用者和晚期採用者，有國家付款人、有地方付款人，還有醫療保險和醫療補助。

This is an incredibly complex equation, and it requires an enormous amount of data and proof. And I think, for example, for us to be able to get contracts like Texas BlueCross BlueShield, which covers over 8 million members in Illinois, BlueCross BlueShield, which I believe covers over 8 million members, Emblem Health Care in New York City. These are very sophisticated groups. They look at the data and they require a lot of diligence before they issue a coverage determination, especially for an advanced diagnostic test like KidneyIntelX. Many of them are now requiring outcomes data, not just utility data. And that requires time, a time function, which is a significant investment. And there's no shortcut. Many of them require FDA. Otherwise, you're deemed to be experimental.

這是一個極其複雜的方程，它需要大量的數據和證明。我認為，例如，我們能夠獲得像 Texas BlueCross BlueShield 這樣的合同，它涵蓋了伊利諾伊州超過 800 萬會員，BlueCross BlueShield，我相信也涵蓋了紐約市超過 800 萬會員，還有 Emblem Health Care。這些都是非常老練的團體。他們會查看數據，並且需要進行大量的調查才能做出覆蓋決定，尤其是像 KidneyIntelX 這樣的高級診斷測試。他們中的許多人現在需要的是結果數據，而不僅僅是實用數據。這需要時間，時間函數，這是一項重大的投資。並且沒有捷徑。其中許多都需要 FDA。否則，您將被視為實驗者。

So we've been very fortunate because from the very beginning at Renalytix, we set this dynamic up. We knew this was going to be an uphill fight to get this. And we've all died on the hill of reimbursement. If you can't get paid, you have a big research project, you don't have a business. So we knew from the very beginning, we had to generate outcomes data. We made the choice to go through FDA. And all of this of course, was focused on getting to the guidelines as well. So it has been a continual update process having been put in the final guidelines is a major help because we are no longer experimental. Nobody can say, you're just a laboratory-developed test. Now we can point to a whole sequence of major payer decisions of draft LCD, guidelines, FDA outcomes data.

所以我們非常幸運，因為從 Renalytix 一開始，我們就建立了這種動態。我們知道，為了實現這一目標，這將是一場艱苦的戰鬥。而我們都死在了償還的山上。如果你拿不到報酬，你就有一個大的研究項目，你就沒有生意。所以我們從一開始就知道，我們必須產生結果數據。我們選擇通過 FDA 進行認證。當然，所有這一切也都是為了獲得指導方針。因此，這是一個持續更​​新的過程，被納入最終指南是一個很大的幫助，因為我們不再是實驗性的。沒有人可以說，你只是一個實驗室開發的測試。現在我們可以指出 LCD 草案、指南、 FDA 結果數據的一系列主要付款人決策。

I cannot see a reason why a healthcare insurer, especially with the risk exposure to chronic kidney disease and diabetes, right, this is not just -- we're not screening people here. These are patients walking into a primary, a very busy primary care physician office with a complex disease, multiple complex diseases that could represent a significant short term actuarial risk. There's no reason, no logical reason why you shouldn't understand risk of that patient. And we're now talking about adding very expensive drug prescription to the table.

我不明白為什麼醫療保險公司，特別是在面臨慢性腎臟病和糖尿病風險的情況下，不在這裡對人們進行篩檢。這些患者走進一家非常繁忙的初級保健醫生辦公室，患有多種複雜的疾病，可能代表著重大的短期精算風險。沒有理由、沒有任何邏輯理由讓你不了解該病人的風險。我們現在正在討論將非常昂貴的藥物處方加入其中。

So prognosis, precision medicine prognosis, which is KidneyIntelX, which can be utilized by the primary care physician. This is key. All right, it's got to be very simple. It's going to be rapid. It's got to be very actionable, which is what we spent a lot of time and money figuring out and having it regulated. This becomes critical to managing the disease. And all of downstream suffering and all of the downstream expense, that becomes critical to the health equity equation in the United States. And I'm pounding the table here because this is the solution for managing chronic disease, getting in early at the primary care level and understanding risk. From there all of the clinical decisions can be made.

因此預後、精準醫學預後，即 KidneyIntelX，可以被初級保健醫生利用。這是關鍵。好吧，這一定非常簡單。它會很快。它必須非常具有可操作性，這也是我們花費了大量的時間和金錢去弄清楚並對其進行監管的原因。這對於控制疾病至關重要。所有下游的痛苦和所有下游的費用，對於美國的健康公平方程式來說都至關重要。我在這裡敲桌子是因為這是管理慢性病、儘早介入初級保健並了解風險的解決方案。從那裡可以做出所有的臨床決策。

And if you don't understand risk -- and we see this now in the real-world data, physicians are not understanding risk without KidneyIntelX. And we see the consequence. Today in the United States, still 50% of the people who enter hemodialysis, do it through the emergency room. We're still having crash catheterizations. We're now prescribing $1,500 a month cycle biologics into patients who may respond or not, who may not be high risk. So unless you understand where you are in the risk spectrum, unless you understand the ability to characterize the disease and you can do it in a very simple way, which is not easy, then you can't control it.

如果您不了解風險——我們現在在現實世界的數據中看到這一點，醫生在沒有 KidneyIntelX 的情況下就無法了解風險。我們看到了後果。如今在美國，仍有50%接受血液透析的患者是在急診室進行的。我們仍在進行緊急導管插入術。我們現在每月為那些可能有反應或沒有反應、且可能不屬於高風險的患者開出價值 1,500 美元的週期生物製劑。因此，除非您了解自己處於風險範圍的哪個位置，除非您了解表徵疾病的能力，並且能夠以非常簡單的方式做到這一點（這並不容易），否則您無法控制它。

So the LCD is a significant event for us and we're continuing to update the payer landscape. I don't have all of the numbers in front of me, but a lot of them are listed on the website and we do issue 8-K's with material events. I would like to see national payers coming on board. They're spending an awful lot of money that they don't need to spend on late-stage kidney disease. if they implement KidneyIntelX across their systems, it is now abundantly clear that preventative medicine goes in place, and you start to prevent progression and you get a much better characterization on these huge populations that you're now insuring. So I think we're in a win-win position for 2024 to knock off the rest of the insurance coverage.

因此，LCD 對我們來說是一件大事，我們將繼續更新付款人情況。我面前並沒有所有的數字，但很多數字都列在網站上，而且我們確實會針對重大事件發布 8-K 報表。我希望看到國家付款人參與其中。他們在晚期腎病治療上花費了大量不必要的金錢。如果他們在整個系統中實施 KidneyIntelX，現在就可以清楚地看到預防醫學已經到位，您可以開始阻止病情進展，並且可以對您現在所承保的龐大人群進行更好的描述。因此，我認為我們在 2024 年將處於雙贏的局面，可以取消剩餘的保險覆蓋範圍。

Okay. That's helpful. And certainly, it would be great to see the LCD go final by September or sooner. I know in the past, James, you talked about a potential opportunity to get an NCD, the National Coverage Determination. Is that still a pathway you guys are looking at? Or is it really just more about getting the LCD and just going from there?

好的。這很有幫助。當然，如果 LCD 在 9 月或更早之前完成最終版本發布，那將是一件非常棒的事情。詹姆斯，我知道過去你談過獲得 NCD（國家覆蓋決定）的潛在機會。這仍然是你們正在考慮的道路嗎？或者實際上只是獲得 LCD 並從那裡開始？

It still is a possibility. We are speaking with CMS. We are speaking with FDA. But I think for all practical purposes, an LCD finishes the game for us. And just to remind everybody, National Government Services is the Medicare contractor that is going to issue -- that has issued the draft LCD. And as long as we process samples in our New York laboratory, we can now build at $950 to National Government Services and get paid. We're being paid now under a convention called ICR individual claim review, it's a little bit cumbersome. So the issuance of an LCD again, will be another incremental smoothing into the clinical pipeline. But we can take a sample from any Medicare beneficiary. Anywhere around the world. As long as we process that sample in our New York laboratory, we can build Medicare. So a final LCD means that we can service the entire Medicare population with KidneyIntelX.

這仍然是一種可能性。我們正在與 CMS 交談。我們正在與 FDA 溝通。但我認為從實際目的來看，LCD 已經為我們完成了遊戲。需要提醒大家的是，國家政府服務部是醫療保險承包商，它已經發布了 LCD 草案。只要我們在紐約實驗室處理樣本，我們現在就可以以 950 美元的價格向國家政府服務機構提供樣品並獲得報酬。我們現在是按照「ICR個人索賠審查」的慣例獲得報酬，這有點麻煩。因此，再次發布 LCD 將會進一步平滑臨床流程。但我們可以從任何醫療保險受益人身上採集樣本。世界各地。只要我們在紐約實驗室處理樣本，我們就可以建立醫療保險。因此，最終的 LCD 意味著我們可以使用 KidneyIntelX 為整個醫療保險人口提供服務。

Alright, that's great. Last question for me. Howard, I appreciate the update on the commercial organization. That sounds like there are approximately 10 people on the sales force. Do you expect to stay there this year? I understand that cash burn and capital is something you have to keep your eye on. But should we expect you to stay flat at 10 this year? Or is there potential to add to that? And then if there was no rate-limiting factor with capital, longer term, how do you see a healthy sales force? What would that look like in a couple of years?

好吧，太好了。我的最後一個問題。霍華德，我很欣賞商業組織的最新消息。聽起來銷售團隊大約有 10 個人。您預計今年還會留在那裡嗎？我知道你必須關注現金消耗和資本。但是我們是否應該期望您今年保持 10 的水平？或是有潛力可以加嗎？那麼，如果沒有資本的限制因素，從長遠來看，您認為銷售團隊會怎樣健康呢？幾年後會是什麼樣子？

Sure, Mark. Yeah. So you're correct. We are currently at 10. In regards to we have today, we are always looking at opportunities that we're opening doors with now as far as access to larger groups. And we have a couple of things that we're working on currently, that if those came to fruition, we would be adding potentially one or two folks.

當然，馬克。是的。所以你是對的。目前我們為 10。就我們今天所擁有的而言，我們一直在尋找機會，以便接觸更大的群體。我們目前正在做一些事情，如果這些事情能夠實現，我們可能會增加一到兩個人。

At the end of the day though, what we're really trying to prove out is what's the productivity that we can see in the new -- with the new team in its first year. So that's really the measuring stick that we're paying the closest attention to. But yes, we would be in very small opportunities. We'd be still cautious and deliberate because of the spend. But there are a couple of inflection points that we want to maximize that would not be able to be covered by our existing team. So we will -- certainly, as those come on board, we'll talk about those, but that would be the adds.

但到最後，我們真正想證明的是，新團隊成立的第一年，我們能看到什麼樣的生產力。所以這確實是我們最關注的衡量標準。但確實，我們的機會非常小。對於支出問題，我們仍會保持謹慎和謹慎。但我們希望最大限度地發揮幾個轉折點，而我們現有的團隊無法涵蓋這些轉折點。所以我們會 — — 當然，當這些加入時，我們會談論它們，但這將是增加的。

I think what we have as far as the markets we're in, as we've discussed before, we follow the actual need markets that have a high penetration rate of type 2 diabetics with chronic kidney disease overlaid with very favorable managed care. Those markets right now for us are Ohio, North Carolina, New York, Florida, Texas, and Louisiana. And so as much as we've been talking about the LCD and additional reimbursement, those are just very strong markets for us across the board, strong from a standpoint of need strong from a standpoint of having the managed care contracts and programs that we need to be successful within those.

我認為，就我們所在的市場而言，正如我們之前討論過的，我們關注實際需求市場，該市場對 2 型糖尿病和慢性腎病的滲透率很高，並且提供非常優惠的管理式醫療。我們目前的市場是俄亥俄州、北卡羅來納州、紐約州、佛羅裡達州、德克薩斯州和路易斯安那州。因此，正如我們一直在談論的 LCD 和額外報銷一樣，這些都是我們全面且非常強大的市場，從需求的角度來看非常強大，從擁有管理式醫療合約和計劃的角度來看非常強大，我們需要在這些合約和計劃中取得成功。

So from an expansion standpoint, yes, they would -- it would be a lot of still looking at opportunities that have those same characteristics, right? We want to go to places first where there's a tremendous need, coupled with who has the best reimbursement. And look, I've had sales organizations of many sizes. Obviously, the number that we would put in the field and deploy would be the type of funding we have at the time. So that's a little hard to answer that one hypothetically, without discussing if you had x dollars, what would you do? I could be more direct there, but just -- yes, we want to expand. We want to continue to raise. We know we can drive results now at the PCP level and we want to better magnify that over time. I just couldn't give you a firm number as we sit here today, other than a couple of additional adds that I foresee over the next couple of months, most likely do some other events that we're working on.

因此，從擴張的角度來看，是的，他們會——仍然會尋找許多具有相同特徵的機會，對嗎？我們希望先去那些有龐大需求的地方，同時考慮那些報銷情況最好的地方。你看，我擁有多種規模的銷售組織。顯然，我們投入和部署的人數將取決於我們當時擁有的資金類型。因此，從假設的角度來回答這個問題有點困難，不討論如果你有 x 美元，你會做什麼？我可以說得更直接一些，但是——是的，我們想要擴大。我們希望繼續籌集資金。我們知道我們現在可以在 PCP 層面推動成果，我們希望隨著時間的推移更好地擴大這一成果。今天我們還不能給你一個確切的數字，除了我預計未來幾個月將增加幾個額外內容之外，很可能還會增加一些我們正在進行的其他活動。

Okay, great. Thanks, guys.

好的，太好了。謝謝大家。

Yi Chen, H.C. Wainwright.

陳懿，H.C.溫賴特。

Good morning. This is Ashton on for Yi Chen. Thank you for taking our questions. First question is what are the hurdles for wide adoption of the test in the VA system? Also, what is the estimated timeframe to achieve cash flow breakeven?

早安.這是 Ashton 為 Yi Chen 表演的。感謝您回答我們的問題。第一個問題是，在 VA 系統中廣泛採用該測試面臨哪些障礙？另外，預計現金流量收支平衡的時間是什麼時候？

So the VA system took me to school. I thought that when we had a general services administration contract, which we still have, which is important by the way for also retaining the price point, right? One of the great lessons in reimbursement is, if you come down a price where you negotiate a lower price to somebody else, you never get it back. So having the General Services Administration lock in the price at $950, which obviously covers the VA system and having CMS also crosswalk to a $950 price. That is the price point. And we have not backed down on that price point. And that retains the margin and the value for the addressable market.

所以 VA 系統讓我入學了。我認為當我們擁有一份一般服務管理合約時，我們仍然擁有這份合同，順便說一下，這對於保留價格點也很重要，對嗎？報銷的一個重要教訓是，如果你與別人協商降價，那麼你就再也拿不回來了。因此，總務管理局將價格鎖定在 950 美元，這顯然涵蓋了 VA 系統，而 CMS 也將價格鎖定在 950 美元。這就是價格點。我們在價格方面也沒有退縮。這保留了目標市場的利潤和價值。

But the VA system, I think we substantially overestimated. We were over optimistic on what we're able to achieve. We had national support, and we really view VA going into it as one entity. And it turns out there something like 170 different individual sites in the VA. Many of them operate differently. And it became incredibly complex in that system to roll out an advanced prognostic like KidneyIntelX. There were many ironies, inefficiencies, and we over hired to go after VA, and we had to do a complete about-face. I still think it's a fabulous market space there are over 100 -- I'm sorry there are over 1 million diabetic kidney disease patients. There are veterans who we should be taking care of that would benefit from KidneyIntelX. And at a future date I want to go back in to the VA and integrate because I do believe it's an important market space. And I do believe we can come from a top-down approach and gain traction.

但我認為，我們大大高估了 VA 系統。我們對自己所能取得的成就過於樂觀了。我們得到了國家的支持，我們確實將 VA 視為一個整體。事實證明，VA 內有大約 170 個不同的獨立站點。其中許多的運作方式不同。在該系統中推出像 KidneyIntelX 這樣的先進預測系統變得極為複雜。存在許多諷刺和低效率的情況，而且我們為了追逐 VA 僱用了過多的人，我們不得不來個徹底的大轉變。我仍然認為這是一個巨大的市場空間，有超過 100 名——對不起，有超過 100 萬名糖尿病腎病患者。我們應該照顧一些退伍軍人，他們將從 KidneyIntelX 中受益。將來我想回到 VA 並進行整合，因為我確實相信這是一個重要的市場空間。我確實相信，我們可以採取自​​上而下的方法並獲得推動力。

But again, in this capital markets environment, which I've never experienced before. I've never experienced such a derating sector. And I never thought that we would have such limited access to the capital markets. We had to drop the VA effort by and large. So I do not expect the VA will be part of our plans in calendar '24. If conditions improve in calendar '25, we'll go back in. But we've learned a few lessons there. It's one of the reasons we've re-org around Howard and his experience having been very successful with broad diagnostics launches, including in cervical cancer and other areas. And we're now focused on a limited high-performing sales force in very specific regions where we have high insurance coverage, large rates of diabetes, and maybe a large clinical provider working alongside us. It takes you a while to figure out the model that's really going to take off.

但是，我以前從未經歷過這種資本市場環境。我從未經歷過如此降級的行業。我從來沒有想到我們進入資本市場的管道會如此有限。我們不得不基本放棄 VA 努力。所以我不認為 VA 會成為我們 24 年計劃的一部分。如果 25 年情況有所改善，我們就會回去。但我們也從中吸取了一些教訓。這是我們圍繞霍華德重組的原因之一，他的經驗在廣泛的診斷產品發布方面非常成功，包括子宮頸癌和其他領域。現在，我們專注於在特定地區組建一支有限的高績效銷售隊伍，這些地區我們的保險覆蓋率較高、糖尿病發病率較高，而且可能有大型臨床服務提供者與我們合作。你需要花一些時間來弄清楚真正能夠起飛的模型。

Where does adoption come in? This has been an ongoing question, and I look at it in two lenses. One, we are still a young company, believe it or not. We really didn't launch KidneyIntelX in force on a commercial basis until just over a year ago. And we are just in April, launching the FDA approved KidneyIntelX. So last month. And diagnostics is the worst business and it's the best business. It's the worst business because you've got across all of these mountains, FDA, Medicare reimbursement, outcomes data, and now guidelines, you got to cross all of those things before a very conservative and codified clinical infrastructure says, okay, this should be ready now to use as a standard of care. We've now crossed all of those things. And this is where I believe diagnostics becomes a very good business because the barriers to entry are very high behind us.

收養從何而來？這是一個一直存在的問題，我從兩個角度來看它。首先，不管你信不信，我們仍然是一家年輕的公司。直到一年多前，我們才真正在商業基礎上大力推出 KidneyIntelX。我們於四月推出了經 FDA 批准的 KidneyIntelX。上個月也是如此。診斷是最壞的生意，也是最好的生意。這是最糟糕的生意，因為你必須跨越所有這些障礙，FDA、醫療保險報銷、結果數據以及現在的指南，你必須跨越所有這些障礙，然後一個非常保守和成文的臨床基礎設施才能說，好的，現在應該可以將其用作護理標準了。現在我們已經跨越了所有這些障礙。我相信診斷會成為一門非常好的生意，因為我們的進入門檻已經很高了。

The deeper I get into diabetic kidney disease; it becomes even more clear how significant a problem this is. And not only is it not going away, but it's growing. And we've got to do something about it. And the something about it is, you got to know early what your risk is. I came out of the prostate cancer world and the analog is very clear, when do you want to know you have cancer? As soon as possible. Because it changes your treatment paradigm, it changes your outcomes, you're suffering, and it changes the cost. The same is true with kidney disease. All of us on the phone are eventually going to start to lose kidney function as we get older. The question is, does it matter? For most of us it doesn't. But for a significant percentage of us, it's going to matter a lot. And the sooner we know, the sooner we can treat it. And we have drugs to treat it now. We didn't five, six years ago. Not like SGLT2 inhibitors and GLP-1s. So there is no rational reason why to me with a FDA approved precision medicine prognostic product that is now in the guidelines and is paid for by insurance, that this is not set up for broad adoption. And it's a matter of time, right? The capital markets isn't giving us much time. And that's okay. But things change. Interest rates will eventually come down. And investor sentiment will change.

我對糖尿病腎病變的研究越深入；這個問題的嚴重性就變得更加明顯了。它不僅沒有消失，反而還在成長。我們必須對此採取行動。關於它的事情是，你必須儘早了解你的風險。我來自攝護腺癌領域，這個類比非常清楚，你什麼時候想知道自己罹患癌症？盡快地。因為它改變了你的治療模式，改變了你的治療結果，改變了你的痛苦，也改變了治療費用。腎臟疾病也是如此。隨著年齡的增長，我們所有打電話的人最終都會開始喪失腎功能。問題是，這很重要嗎？但對我們大多數人來說，情況並非如此。但對於我們當中很大一部分的人來說，這很重要。我們越早知道，就能越早治療。現在我們有藥物可以治療。五、六年前我們還沒有這樣做。與 SGLT2 抑制劑和 GLP-1 不同。因此，對我來說，沒有理由認為已經獲得 FDA 批准、並且已納入指南且由保險支付的精準醫療預測產品不適用於廣泛採用。這只是時間問題，對吧？資本市場沒有給我們太多時間。沒關係。但事情發生了變化。利率最終會下降。投資人情緒也會改變。

So for us. It's one foot in front of the other. We have a very focused high performing sales force that is going into very specific regions. We're not boiling the ocean. We've learned an awful lot over the last couple of years about what the messaging is. To the physician, it was ordering KidneyIntelX. And that messaging right now is very clear, a doctor we have a tool which goes after one of the major complications in your diabetes patient and it's FDA approved. We accept all insurance. It's in the clinical guidelines. So it's guidelines standard of care. And here's what happens when you use it, not only to improve your kidney disease, but you improve your diabetes patients' health.

對我們來說也是如此。一隻腳在另一隻腳前面。我們擁有一支非常專注、有效率的銷售隊伍，負責特定的區域。我們不會煮沸海洋。過去幾年來，我們對於訊息傳遞有了非常多的認識。對於醫生來說，這是在訂購KidneyIntelX。現在傳達的訊息非常明確，對於醫生來說，我們有一種工具可以治療糖尿病患者的主要併發症之一，而且它已經獲得了 FDA 的批准。我們接受所有保險。它包含在臨床指南中。所以這是護理的指導標準。當你使用它時，不僅可以改善你的腎臟疾病，還可以改善糖尿病患者的健康。

So the rationale is very strong. It's comprehensive, its data driven. We've invested heavily in the data, which now put us in a good position to drive adoption incrementally. We've got to watch the cost, that's critically important. But we've got the right team in place. We have right sized the organization. So we're not burning a ton of cash for a Medicare reimbursed clinical diagnostic company, services company. Our operating burn is actually quite good. And now we just got to keep our nose down and put one foot in front of you there. And I think the adoption will come. I think it is a function of time at this point. The LCD is going to help when the final is issued. That will raise visibility again.

因此，其理由非常充分。它是全面的並且由數據驅動。我們已經在數據方面投入了大量資金，這使我們目前處於有利地位，可以逐步推動採用。我們必須注意成本，這至關重要。但我們已經擁有合適的團隊。我們已經正確調整了組織的規模。因此，我們不會為醫療保險報銷的臨床診斷公司和服務公司投入大量資金。我們的營運成本其實相當不錯。現在我們只需低下頭，將一隻腳放在你面前。我認為，這一進程將會順利進行。我認為目前它是時間的函數。當最終結果發佈時，LCD 將會提供協助。這將再次提高知名度。

And now the question is how do we maximize shareholder value? And that comes down to optionality. And optionality comes in the form of a competitive strategic process. It comes in the form of runway, which is a function of equity capital. So we want to have a long runway as possible, so that we can run a competitive process or we can continue to grow the business on an incremental basis. We have a number of significant opportunities in front of us in 2024 in terms of additional hospital partners, additional areas where we can roll out. And it's a very powerful message when you walk into the primary care physician and say, this is a simple actionable solution, which is covered by insurance and FDA approved and in the guidelines. So for the first time, we are in a position where we have checked all the boxes. And I cannot believe that adoption will not follow. Of course, we have to prove it. And I think now that we built a direct to physician sales force of high performers under great leadership. Again, that provides us with additional optionality to prove out the business model.

現在的問題是，我們要如何實現股東價值最大化？而這歸結為可選性。可選性以競爭策略過程的形式出現。它以跑道的形式出現，是股本的功能。因此，我們希望盡可能延長跑道，以便我們能夠運行競爭流程，或能夠繼續逐步發展業務。2024 年，在增加醫院合作夥伴、擴大業務覆蓋範圍等方面，我們面臨許多重大機會。當您走進初級保健醫生那裡並說這是一個簡單可行的解決方案，並且受到保險覆蓋、獲得 FDA 批准並符合指南要求時，這是一個非常強大的信息。因此，這是我們第一次處於已檢查完所有箱子的狀態。我無法相信政府不會採納這項政策。當然，我們必須證明這一點。我認為現在我們在出色的領導下建立了一支由高績效人員組成的直接面向醫生的銷售團隊。再次，這為我們提供了額外的選擇來證明商業模式。

Thank you so much for that. And next question is, what is the estimated timeframe to achieve cash flow breakeven?

非常感謝。下一個問題是，預計現金流量收支平衡的時間是什麼時候？

Yeah. So we're not going to answer that because that's a forecast, which is not what we're going to do. But certainly, our breakeven point is much lower than it was.

是的。所以我們不會回答這個問題，因為這只是一個預測，而這不是我們要做的。但可以肯定的是，我們的損益平衡點比以前低得多。

Okay --

好的--

With the re-organization of the company.

隨著公司組織結構的重新調整。

Okay. Thank you for your time.

好的。感謝您的時間。

Thank you. Appreciate it.

謝謝。非常感謝。

(Operator Instructions) [Bobby Demmer, TM Capital Partners]

（操作員說明）[Bobby Demmer，TM Capital Partners]

Hey, guys. Thanks for taking the call. Can you hear me?

嘿，大家好。感謝您接聽電話。你聽得到我嗎？

Hey, Bobby. Yes, we can.

嘿，鮑比。是的，我們可以。

I want to tailor this towards Howard, is kind of building on what you're talking about here. But you had 806 tests that you reported in the quarter, and you said that 82% of those were billable. So back-of-the-envelope that's takes us to 650 billable tests. Of that number, how many of those were system driven and how many of those were salespeople driven?

我想根據霍華德的情況對此進行調整，這有點建立在你在這裡談論的內容之上。但是您本季度報告了 806 項測試，其中 82％ 是可收費的。因此，簡單計算一下，我們需要進行 650 次計費測試。其中有多少是由系統驅動的，有多少是由銷售人員驅動的？

So OJ, we have about 40% of that number, Bobby is the actual TCP sales. And the other is Sinai, roughly.

所以 OJ，我們大約有 40% 的這個數字，Bobby 是實際的 TCP 銷售額。另一個是西奈，大致是如此。

Is Sinai. And do you have weight in that mix or is it just Sinai?

是西奈。您在這種組合中佔有重要地位嗎，還是只有西奈才有？

Just Sinai.

只是西乃。

Okay. And is that the mix that you expect to go forward with 40,60 salespeople? The system driven?

好的。您預計未來銷售人員人數會是 40 到 60 人嗎？系統驅動？

No, I would actually expect that in the not-too-distant future that PCP would be the largest bucket of our business, right? We'll have the enterprise accounts and will have PCP. But in the future, I would expect PCP to be the largest chunk of our business volume.

不，我實際上預計在不久的將來 PCP 將成為我們業務中最大的業務領域，對嗎？我們將擁有企業帳戶並擁有 PCP。但在將來，我預期PCP將成為我們業務量中最大的一部分。

Like flipping those?

喜歡翻轉那些嗎？

I would hope to do even better than that, but yes.

我希望做得更好，但是是的。

Okay. And kind of looking at growth trajectory here. If you've got kind of 40% of those is PCP salespeople driven, that's -- just lower 300 test, just use that number. You have seven salespeople that have been there for quite a while now, since August. So how are we looking at those salespeople who have been around and getting to, say, 1,800 tests out of those salespeople as opposed to 300 tests out of those salespeople.

好的。並且觀察一下這裡的成長軌跡。如果其中 40% 是由 PCP 銷售人員驅動的，那麼 — — 只需進行低於 300 的測試，然後使用該數字即可。你們有七名銷售人員，他們從八月開始就已經在那裡工作了很長一段時間。那麼，我們如何看待那些已經到場的銷售人員，並且對這些銷售人員進行了 1,800 次測試，而不是 300 次測試。

Yeah. So I would say a couple of things. One is, at one point, we had a much larger sales organization, correct? So the three people that were I called legacy earlier, actually have three very productive territories that they're the right profile, the folks that we obviously wanted on the team. So that's that first group. The group that started in August, again, that's still fairly new. So we've got a couple of quarters under their belt. And then of course, we had the three new folks that started in December who this past quarter is their first.

是的。因此我想說幾件事。一是，我們曾經有過規模更大的銷售組織，對嗎？因此，我之前稱之為「遺產」的三個人實際上負責三個非常有成效的領域，他們是合適的人選，顯然也是我們想要加入團隊的人。這就是第一組。該團體於八月成立，仍然相當新。我們已經獲得了他們幾個季度的成功經驗。當然，我們有三位新員工，他們是 12 月加入的，上個季度是他們的第一季。

So what we have as far as the new team is, we've got one data point, right? We've got the quarter that we're talking about now. We alluded to in our comments in the original script that we anticipate this quarter to be similar in growth rates of this past. And beyond that, that gives us our second data point. At that point I'll be able to look at what's occurring, momentum, et cetera, just start thinking a little bit more broadly as far as further down the line. But for right now, I'm focused on this current quarter and not necessarily four or five quarters out depending on growth rate to hit the numbers that you're talking about.

那麼，就新團隊而言，我們有一個數據點，對嗎？我們已經到了現在正在討論的這個季度。我們在原始腳本的評論中提到，我們預計本季的成長率將與過去相似。除此之外，這給了我們第二個數據點。到那時，我將能夠觀察正在發生的事情、動力等等，開始更廣泛地思考更長遠的問題。但就目前而言，我主要專注於當前季度，而不一定是未來四到五個季度，這取決於成長率以達到您所說的數字。

So I just want to make a projection on a data point of one. to I want to get this current quarter under our belt or take a look at it. And I think I'd answer that a little bit more definitively our next call.

所以我只想對一個數據點做一個投影。我想了解本季的情況或看一下它。我認為下次通話時我會更明確地回答這個問題。

So you're bucketing these seven salespeople and the new three salespeople in the same pocket regardless of how long they've been operating and doing their work in their sales channels?

所以，您把這 7 名銷售人員和新增加的 3 名銷售人員歸為一類，不管他們在各自的銷售管道中工作了多久？

No, I wouldn't necessarily say it that way. I'm just saying that we are looking at trajectory of what it takes with a slightly different profile of person and different backgrounds set and what they can do and how rapidly can they do it. And we didn't expect really anything for the first month or two. So what we're really looking at as only a few months of data on particularly the new folks and seeing where that trajectory is going. To date, we're very pleased with it. And I expect it to continue to be better over time. But I just think it's too early -- even again with the folks starting in August they're relatively new. We've made some changes, et cetera. I just think you're asking a question that's a little further out than what I'm comfortable projecting to you today.

不，我不一定會這麼說。我只是說，我們正在研究略有不同的個人資料和不同背景所需的軌跡，以及他們能做什麼以及他們能多快完成。對於前一兩個月我們並沒有抱太大的期望。因此，我們實際上只關注新員工幾個月的數據，並觀察其發展軌跡。到目前為止，我們對此非常滿意。我希望隨著時間的推移它會變得越來越好。但我認為現在還為時過早——即使是八月才開始工作的人，他們也相對較新。我們做出了一些改變等等。我只是認為你問的問題比我今天願意向你提出的問題有些偏見。

Okay. I mean just because James was talking about distant runway, right? Because the market I think is going to have to see sales volume here pick up.

好的。我的意思是只是因為詹姆斯在談論遠距離跑道，對吧？因為我認為這裡的市場將會看到銷售量回升。

And I think we will have catalysts that will allow that to be better upon time. Just again, with the team settled, we're happy with what we have today. We have one quarter under our belts with that group. And I will feel a little differently as far as more future discussion once we conclude this quarter. That's all I'm trying to communicate to you.

我認為我們會有催化劑讓情況隨著時間的推移而變得更好。再次重申，隨著團隊穩定，我們對今天的成績感到滿意。我們與該團隊合作已有一個季度了。一旦我們結束本季度，對於未來的更多討論，我會有稍微不同的看法。這就是我想要和你們傳達的全部訊息。

All right. Well, thank you for answering that. One more, if you don't mind.

好的。好吧，謝謝你回答這個問題。如果你不介意的話，再說一個。

Sure.

當然。

What do you expect the conversion rate to be for getting in front of doctors?

您預計醫師面前的轉換率是多少？

Of course. New doctors per quarter?

當然。每季有新醫生嗎？

Yeah, new doctors per quarter. And then once you're in front of those doctors, what kind of conversion rates are you expecting?

是的，每季都會有新醫生。那麼當您站在這些醫生面前時，您期望的轉換率是什麼樣的呢？

Yeah. So I would say -- if I sort of just take a step back and if you are going to ask me, what's the thing that surprises me the most on a positive, I would say that our clinical message now is very tight. And getting a clinician to say that their interest in tests, I'm not going to call it easy because it's not. It's still hard work. But the message is very sound, and it holds together and they get it.

是的。所以我想說——如果我退一步考慮，如果你要問我，最令我驚訝的事情是什麼，我會說我們現在的臨床資訊非常嚴格。讓臨床醫生表達他們對測試的興趣，我不會說這很容易，因為這並不容易。這仍然很艱苦。但這個訊息非常正確，而且完整，他們也明白。

The most challenging part is patient identification. So it's them being able to go into their patient data and finding, all right, who are all my type 2 diabetics who have I stayed with chronic kidney disease and who has the clinical features that we need to actually run our test? That's the biggest barrier to broader adoption. And it's a slower process that takes a lot of handholding and it's not yet a sticky business. We are working on ways to make it more sticky, by making ordering simpler, providing better nephrology access, excuse me, nephrology -- providing better phlebotomy access, and taking some of the barriers that are -- been pushed us on the past. But the most important thing is getting them into that rhythm of identifying patients before they come in for their next checkup. That's the biggest challenge.

最具挑戰性的部分是患者識別。所以他們能夠進入病人的數據並找出誰是所有 2 型糖尿病患者，誰患有慢性腎病，誰具有我們實際進行測試所需的臨床特徵？這是更廣泛採用的最大障礙。這是一個較慢的過程，需要大量的人力投入，而且還不是一個棘手的業務。我們正在努力使其更具黏性，透過簡化訂購，提供更好的腎臟病學途徑，對不起，腎臟病學 - 提供更好的靜脈穿刺途徑，並消除過去給我們帶來的一些障礙。但最重要的是讓他們養成在病人下次檢查前就辨識出患者的習慣。這是最大的挑戰。

So our adoption is definitely different than it was in the past. We are seeing an uptick on how quickly the doctor that closes today, the tests they start ordering over the subsequent months. We are definitely seeing a change of behavior there. But I think we can even have a bigger inflection point as we continue to hone on a very simple way for them to identify these patients. And when they have them identified, we will definitely see conversion ramp change, I think quite a bit.

所以我們的採用肯定與過去不同。我們看到，今天下班的醫生在接下來的幾個月開始安排的檢查速度上升。我們確實看到那裡的行為改變了。但我認為，隨著我們不斷完善一種非常簡單的方法來識別這些患者，我們甚至可以擁有更大的轉折點。當他們確定了這些變化後，我們肯定會看到轉換坡道的變化，我想會相當多。

Okay. Final one, and I'll let you go. I'm trying to gauge how much of the $14 million TAM we can expect Renalytix to capture. And if you have a 100 -- just using round numbers, if you have 100 new PCP presentations, how many of those doctors do you expect or do your salespeople, are they being expected to convert to actually order a test? And those who have ordered the test? What's the -- how many following testers, the expectation is going to be for those salespeople out of that particular doctor who orders?

好的。最後一次，我就放你走了。我正在試圖估計我們預計 Renalytix 能夠獲得 1400 萬美元 TAM 中的多少收益。如果有 100 個 — — 僅使用整數，如果您有 100 個新的 PCP 演示，您期望其中有多少醫生或您的銷售人員會轉換並實際訂購測試？還有那些下令進行測試的人嗎？對於那些來自特定醫生的訂購產品的銷售人員來說，期望有多少名後續測試者？

I mean, that's just like a granularity that we've just chosen not to disclose yet. I mean, again, we're looking at all the things that you've just described, right? What I'd like to do is get another quarter under my belt to be more definitive. Again, it's a green team that we're doing some good things. But you're asking the right questions and you're asking about the right measurements and that's just not a granularity that we're ready to go to.

我的意思是，這只是我們選擇暫時不披露的粒度。我的意思是，我們正在再次研究您剛才描述的所有事物，對嗎？我希望再累積一個季度的經驗，以便更加明確。再說一次，我們是一支綠色團隊，正在做一些好事。但你問的是正確的問題，你詢問的是正確的測量方法，而這並不是我們準備要達到的粒度。

Okay. Well, I appreciate your time. Thank you.

好的。好吧，我很感謝您抽出時間。謝謝。

I think it's important to note that there are a whole sequence of incremental changes which come together to reduce the resistance in the clinical pathway. Obviously, patient identification is one of them. One of the things that Howard has brought to the table is the sequence of incremental improvements. I referred to this in the script reading, but for example, the physician order requisition sheet. We revised that in a compliant fashion, and we revised that to be now FDA compliant with the FDA product launch in April, but it's a much simpler procedure from what we originally had. And that's a function of experience in the real-world. Increasing phlebotomy access, absolutely critical. And these are mundane things, but collectively, they add up to reducing the resistance in the pathway, which lead to better adoption. So we've now significantly increased the access of patients to blood draw stations across the country, and it took us a while to figure that one out. But all of these changes add up and I believe will be reflected in the adoption cycle. Howard, I don't know if you want to add anything to that?

我認為值得注意的是，一系列漸進式變化共同作用以減少臨床路徑中的阻力。顯然，患者識別就是其中之一。霍華德提出的建議之一是逐步改進的順序。我在劇本閱讀中提到了這一點，例如醫生醫囑申請表。我們以合規的方式對其進行了修改，並且我們對其進行了修改以使其現在符合 FDA 的要求，以便 FDA 產品在四月份推出，但與我們原來的程序相比，這是一個簡單得多的程序。這是現實世界經驗的功能。增加靜脈穿刺的機會，絕對關鍵。這些都是平凡的事情，但綜合起來，它們可以減少前進道路上的阻力，從而實現更好的採用。因此，我們現在大大增加了患者在全國各地抽血站的可及性，我們花了一段時間才解決這個問題。但所有這些變化加起來，我相信都會反映在採用週期中。霍華德，我不知道您是否想補充一點？

No, I think that's right. What we're really trying to do is make it easier to do business with us, right? And really improve the customer experience. And the more that we raise that, back to your question, then we can start thinking about deeper penetration and so forth. But we have streamlined a lot of processes. Because again, we are a send-out test, right? So we are disruptive to their workflow to utilize us, which there's -- other companies are in the same boat. So that's not a negative. It's just, it's a reality. And it takes some work and it takes some some strong relationship building to keep that pedal on those until they hit their rhythm. And once they hit that rhythm, then things can happen more systematically. But there's a lot of touch points, particularly in the early few months of integration in an office that needs to be couple of times a week.

不，我認為是這樣。我們真正想做的是讓與我們做生意變得更容易，對嗎？並真正改善客戶體驗。我們越是提出這一點，回到你的問題，我們就可以開始考慮更深入的滲透等等。但我們已經簡化了很多流程。因為我們再進行一次發送測試，對嗎？因此，我們會擾亂他們的工作流程來利用我們，其他公司也面臨同樣的情況。所以這並不是什麼壞事。這只是現實。這需要做一些工作，也需要建立一些牢固的關係來讓他們保持這種狀態直到找到自己的步調。一旦他們掌握了這個節奏，那麼事情就會更加有序地發生。但是有很多接觸點，特別是在辦公室整合的最初幾個月，每週需要進行幾次。

So back to your question, is we're still measuring all the things that you were referring to. But I just don't think we have enough time to give you an answer that I would feel highly confident in. So that's a lot of the learnings that we're still doing. But yes, a lot of process improvements are going over very well. I mean, just a simple and just to point out what James is talking about, a better easier to use form. Well, if it takes three minutes to fill out the old one and it takes about thirty seconds to do the new one, the office thinks very favorably towards that, right? I mean, it takes them less time. And we're asking them to actually add time to what they are already doing it during their day. But more importantly, our test only requires three clinical features now. It used to require seven with the LDT. Those are seven results that someone in that practice had to go look up and put it onto our test requisition form. Now they only have to go get three. And those three are actually very commonly used. So it's a real easy lift to ask for those. So there's a lot of little things that may not sound that big to you. But when you're out there and the clinician, it's big and important to them, and we're addressing them one by one. So that just, again, it goes back to what you're asking is, will that help us ramp this business faster? The answer is yes.

回到你的問題，我們是否仍在衡量你所提到的所有事物。但我認為我們沒有足夠的時間來給你一個讓我非常有信心的答案。所以我們還在不斷學習很多東西。但確實，很多流程改善都進展得很順利。我的意思是，只是簡單地指出詹姆斯正在談論的內容，一種更好更容易使用的形式。好吧，如果填寫舊表格只需三分鐘，而填寫新表格只需三十秒，那麼辦公室會對此非常贊成，對嗎？我的意思是，他們花費的時間更少。我們實際上要求他們在日常工作中增加時間。但更重要的是，我們的測試現在只需要三個臨床特徵。過去，LDT 需要 7 個。這是該實踐中的某個人必須尋找的七個結果，並將其放入我們的測試申請表中。現在他們只需去拿三個。這三種其實是非常常用的。因此，提出這些要求真的很容易。因此，有很多小事對你來說可能聽起來不那麼重要。但是當你和臨床醫生在一起時，這對他們來說是一件大事，非常重要，我們會一一解決這些問題。所以，這又回到你要問的問題，這是否有助於我們更快發展業務？答案是肯定的。

Jens Lindqvist, Investec.

Investec 的 Jens Lindqvist。

Hi there all. Just a couple of quick ones for me. First of all, on the pricing, the $535,000 of revenue you reported for the quarter, I mean that translates into just over $800 per billable test, which is quite a bit off the $950 that Mount Sinai is committed to paying under that new commercial agreement, which has been in place through this quarter, if I understand it correctly. So can you just help me understand that dynamic, please. There appears to be some pretty heavy discounting in the PCP channel? And is that something we should extrapolate going forward? That's my first question.

大家好。對我來說，只有幾個簡單的問題。首先，關於定價，您報告的本季度 535,000 美元的收入，我的意思是，這相當於每次計費測試 800 多美元，如果我沒有理解錯的話，這與西奈山根據本季度實施的新商業協議承諾支付的 950 美元相差很大。所以你能幫助我理解這種動態嗎？PCP 頻道好像有相當的折扣？這是我們未來應該推斷的事情嗎？這是我的第一個問題。

The second one is on the strategic review that is ongoing at the moment. I appreciate you probably can't say too much about it, but could you provide some form of indicative timeline here because the -- I mean, the strategic review, I guess will determine for how long potential acquirers are allowed anonymity, et cetera, under the Takeover Code. Say, when can we expect some form of update in terms of whether you will pursue an M&A route or a different strategic option for commercialization? Thank you.

第二個是關於目前正在進行的策略審查。我知道您可能不能透露太多，但您能否在此提供某種形式的指示性時間表，因為——我的意思是，我猜戰略審查將決定潛在收購者根據《收購守則》可以保持匿名多長時間等等。說說看，我們什麼時候可以得到某種形式的更新，關於您是否會採取併購途徑或不同的商業化策略選擇？謝謝。

So on the strategic option, again, we're limited in what we can say, and I'm now becoming familiar because this is a UK convention. And it was impressive to me under the UK convention, how seriously the takeover panel takes approaches. And if there's a whiff of a strategic interest in the company, then you have an obligation to let the market know. And so we were up -- this was a little bit more than a whiff with regard to us in the unsolicited approach. So we had an obligation to announce. The advantage of announcing is and again, I'm not an expert, I'm not a lawyer. So please take this with an element of grain of salt. But now that we have announced, it creates a much easier process to talk to additional players without disclosure requirements. And so the process will take its own life.

因此，關於戰略選擇，我們能說的內容再次受到限制，而且我現在對此越來越熟悉，因為這是英國的慣例。令我印象深刻的是，根據英國公約，收購委員會採取的措施非常嚴肅。如果你對該公司表現出一絲策略利益，那麼你就有義務讓市場知道。所以我們 — — 對我們來說，這種未經請求的做法只不過是一絲氣息而已。因此我們有義務宣布。宣布的優勢在於，我再說一遍，我不是專家，也不是律師。因此，請對此保持謹慎態度。但既然我們已經宣布了這一消息，那麼與其他參與者的談判就變得更加容易，並且無需披露要求。因此，這個過程將會自行結束。

I don't know the timeline. People that are looking at this include large, company players that have long timelines and leads. And obviously, the more sales that we accrue in that process, the better it will be. So taking a little bit of time is not a bad thing. But again, I don't want to say anymore, but we do expect the process to be competitive and we'll continue to move along. And ultimately what happens, I don't know, but again, it goes back to maximizing the shareholder value and creating optionality in what is an incredibly difficult market right now.

我不知道時間表。關注此事的人包括擁有長期時間表和領先優勢的大型公司參與者。顯然，我們在過程中累積的銷售額越多，效果就越好。所以花一點時間並不是一件壞事。但是我再說一遍，我不想再說了，但我們確實希望這個過程是具有競爭力的，我們會繼續前進。最終會發生什麼，我不知道，但再說一次，這又回到了最大化股東價值和在當前極其困難的市場中創造選擇性的問題。

In terms of pricing, and then OJ will cover this. The price is $950 and we do not discount that for all intents and purposes. We fought hard to achieve CMS pricing at $950, General Services Administration pricing at $950. That is our price and we will not compromise. However, within the complexity of the insurance infrastructure, not every test ultimately gets paid. This is the standard convention. So we would expect. And then OJ, you correct me, an average price going forward of somewhere in the mid-800s.

在定價方面，OJ 將會介紹這一點。價格為 950 美元，但我們無論如何都不會打折。我們努力爭取將 CMS 定價定為 950 美元，將總務管理局定價為 950 美元。這是我們的價格，我們不會妥協。然而，由於保險基礎設施的複雜性，並非每項測試最終都會得到賠償。這是標準慣例。我們也期望如此。然後 OJ，你糾正我一下，平均價格將會在 800 多美元左右。

So right. So the math you're working out, Jens, is not the result of any discounting. So it's 806 total tests, 82% are billable. So, 662 billable tests. And not every one of those is recognizable right away because some of them are covered by insurance that we don't have a contract with. Many of those do ultimately pay. And if they don't pay the full $950, we do appeal those, et cetera. So the difference you see there is just a result of that timing. So about 80% of that billable testing volume is immediately recognizable. That goes into the revenue line. The rest ultimately, at least some of the rest we collect over time.

太對了。因此，Jens，你計算的數值並不是任何折扣的結果。因此，總共進行了 806 次測試，其中 82％ 是可收費的。因此，需要付費的測試有 662 個。但並不是每一個都能立即被識別，因為其中一些是我們未簽訂合約的保險所涵蓋的。其中許多最終都得到了回報。如果他們不全額支付 950 美元，我們會提出上訴等等。所以您看到的差異只是時間安排的結果。因此，大約 80% 的可計費測試量是可以立即識別的。這筆錢就進入收入線了。最終，我們會隨著時間的推移收集剩餘的部分。

Okay. Thank you.

好的。謝謝。

Thank you. And I'm showing no further questions in the queue at this time. Ladies and gentlemen, this concludes today's conference. Thank you for your participation and you may now disconnect.

謝謝。目前隊列中沒有其他問題。女士們、先生們，今天的會議到此結束。感謝您的參與，您現在可以斷開連接。