Renalytix PLC (RNLX) 2024 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Renalytix conference call to review first quarter fiscal year 2024 financial results. At this time, all participants are in listen only mode. We will be facilitating a question and answer session towards the end of today's call.

女士們先生們早安，歡迎參加 Renalytix 電話會議，回顧 2024 財年第一季的財務表現。此時，所有參與者都處於僅聽模式。我們將在今天的電話會議結束時安排問答環節。

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.

謹此提醒，本次通話將會被錄音以供重播。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。

Thank you, [Livia.] Thank you all for participating in today's call. Joining me today from Renalytix to provide formal remarks are James McCullough, CEO; Howard Doran, Chief Business Officer; Tom McLain, President; and James Sterling, CFO.

謝謝，[Livia]。今天，Renalytix 執行長 James McCullough 與我一起發表正式演講；霍華德‧多蘭，首席商務官；湯姆‧麥克萊恩，總裁；和首席財務官詹姆斯·斯特林。

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.

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事件、結果或績效的陳述屬於前瞻性陳述。

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.

這些陳述的例子包括但不限於潛在的好處，包括 KidneyIntelX 的經濟節省； KidneyIntelX 的商業前景，包括 KidneyIntelX 是否會成功地被醫生採用、分發和行銷。

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.

我們對報銷決定以及 KidneyIntelX 降低慢性和末期腎病成本的能力的期望；優化護理服務並改善病患治療效果；我們市場的趨勢以及政府政策變化的潛在好處。

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 and regulatory submissions, our business strategies and future growth, including plans, expectations, and opportunities for financing our operations; and revenue projections and guidance.

COVID-19 和其他世界事件對我們業務的影響；我們對產品開發、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，包括計劃、期望和為我們的營運融資的機會；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 on 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 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.

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，無論是由於新資訊、未來事件或其他原因。

This conference call contains time-sensitive information, and is accurate only as of the live broadcast today, November 14, 2023. I'll now turn the call over to James McCullough. James?

本次電話會議包含時間敏感信息，僅截至今天（2023 年 11 月 14 日）直播時準確。詹姆士？

Thank you, Peter. Good morning. Good afternoon.

謝謝你，彼得。早安.午安.

Given lousy sector market conditions in the early stage of our commercial rollout, we have been proactively organizing the company to last long term while we leverage our proprietary technology to unlock value. First, we are in discussions to raise long-term funding, which would extend our operating runway considerably. While there are certainly no guarantees, we are targeting funding to be in place before year's end.

鑑於我們商業推廣初期的行業市場狀況不佳，我們一直在積極組織公司以實現長期發展，同時利用我們的專有技術來釋放價值。首先，我們正在討論籌集長期資金，這將大大擴展我們的營運跑道。雖然不能保證，但我們的目標是在年底前到位資金。

Second, now that we have achieved FDA and published KidneyIntelX's real-world outcomes performance data, we are in a position to substantially reduce our spend rate. This includes a more than 35% reduction in payroll expense, and a more than 30% reduction in SG&A. These cuts are across the company, including executive compensation. And while it is difficult for those employees affected, it is the right thing to do given the current environment, and the opportunity to maximize resources against our sales efforts.

其次，既然我們已經獲得 FDA 認證並發布了 KidneyIntelX 的真實世界結果表現數據，我們就可以大幅降低我們的支出率。這包括工資費用減少 35% 以上，SG&A 減少 30% 以上。這些削減涉及整個公司，包括高階主管薪酬。雖然這對受影響的員工來說很困難，但考慮到當前的環境，以及在我們的銷售工作中最大限度地利用資源的機會，這是正確的做法。

We have, and are continuing to, shift the composition of the company to focus on sales. With this commercial realignment, approximately half of our employee base is now directly responsible for sales and revenue recognition. Our new Chief Business Officer, Howard Doran, will detail sales force efforts and related initiative shortly.

我們已經並將繼續將公司的結構轉變為專注於銷售。透過這次商業調整，我們大約一半的員工現在直接負責銷售和收入確認。我們的新任首席商務官霍華德·多蘭 (Howard Doran) 很快就會詳細介紹銷售人員的工作和相關措施。

Third, we are optimistic that short term events in fiscal 2024 can help spur testing growth. These include, one, KidneyIntelX Epic integration into Atrium Health, which should be finalized in December. Two, other anticipated hospital systems coming online with KidneyIntelX for calendar 2024. Three, expected inclusion of KidneyIntelX and the final updated international kidney guidelines publication shortly.

第三，我們樂觀地認為 2024 財年的短期事件有助於刺激測驗成長。其中包括，第一，KidneyIntelX Epic 與 Atrium Health 的整合，預計將於 12 月完成。第二，其他預期的醫院系統將在 2024 年與 KidneyIntelX 一起上線。

Four, progress towards a Medicare local coverage determination, or LCD, with National Government Services, the Medicare contractor governing our New York lab. Five, initiation of payment on KidneyIntelX billing from a second Medicare contractor First Coast Options last month. Six, additional expected major insurance coverage decisions this fiscal year. And seven, importantly, publication of new KidneyIntelX outcomes data already submitted for peer review.

第四，與管理我們紐約實驗室的醫療保險承包商國家政府服務部一起，在醫療保險當地承保範圍確定（LCD）方面取得進展。第五，上個月第二家 Medicare 承包商 First Coast Options 開始使用 KidneyIntelX 帳單付款。六、預計本財年新增重大保險承保決策。第七，重要的是，新的 KidneyIntelX 結果數據的發布已提交同行評審。

Following FDA de novo marketing authorization, June 29 draft guidelines, inclusion, comprehensive reimbursement and proven published performance to improve diabetes and kidney health, KidneyIntelX is in a unique position to change preventative medicine in this very large and costly population health menace.

繼FDA 重新行銷授權、6 月29 日起草的指南、納入、全面報銷以及經過驗證的已公佈的改善糖尿病和腎臟健康的性能之後，KidneyIntelX 處於獨特的地位，可以改變預防醫學，應對這一巨大且昂貴的人口健康威脅。

Recent news highlighting potential breakthrough performance against diabetes and kidney disease, including the early stoppage of the Novo Nordisk FLOW trial for their GLP-1 therapeutic Ozempic, signal a new era in kidney disease preventative medicine. There are now at least three classes of drugs available for treatment in the space with more to follow.

最近的新聞強調了針對糖尿病和腎臟疾病的潛在突破性表現，包括提前停止諾和諾德 GLP-1 治療藥物 Ozempic 的 FLOW 試驗，標誌著腎臟疾病預防醫學的新時代。目前至少有三類藥物可用於該領域的治療，並且還將推出更多藥物。

As we saw this month at the American Society of Nephrology Kidney Week Conference in Philadelphia, there was a market shift towards preventative medicine in the kidney space that will place increasing burden on primary care to understand which patients are at risk, and what medication should be used when. We firmly believe that knowing the patient biology with a blood biomarker-driven, FDA-approved and widely reimbursed KidneyIntelX, will be a critical part of the strategy to balance ballooning treatment costs, potential side effects, and cocktail therapeutic applications in this era.

正如我們本月在費城舉行的美國腎臟病學會腎臟週會議上看到的那樣，腎臟領域的市場正在轉向預防醫學，這將給初級保健帶來越來越大的負擔，以了解哪些患者處於危險之中，以及應該使用什麼藥物時使用。我們堅信，透過血液生物標記驅動、FDA 批准且可廣泛報銷的 KidneyIntelX 來了解患者生物學，將成為平衡這個時代不斷膨脹的治療成本、潛在副作用和雞尾酒治療應用的策略的關鍵部分。

We are pursuing programs to validate KidneyIntelX technology drug response scores to these various therapeutics with pharma industry players, and our partners at Johnson Diabetes Center and the Mount Sinai Health System. A KidneyIntelX technology therapeutic response clinical program is something we hope to be able to report on as early as next calendar year.

我們正在與製藥行業參與者以及我們在約翰遜糖尿病中心和西奈山衛生系統的合作夥伴一起開展項目，以驗證 KidneyIntelX 技術對這些不同療法的藥物反應評分。我們希望最快能夠在明年報告 KidneyIntelX 技術治療反應臨床計劃。

Our experience with the FDA de novo pathway in achieving broad-scale reimbursement and artificial intelligence-enabled blood biomarker diagnostics should prove especially valuable in commercial efforts here. We look forward to updating you through 2024 and all of these developments, and I will now turn it over to Howard Doran, our Chief Business Officer, to discuss aspects in sales. Good morning, Howard.

我們在 FDA 從頭途徑實現大規模報銷和人工智慧支援的血液生物標記診斷方面的經驗應該在商業努力中證明特別有價值。我們期待向您通報 2024 年的最新情況以及所有這些進展，我現在將其交給我們的首席商務官霍華德·多蘭 (Howard Doran)，討論銷售方面的問題。早安，霍華德。

Thank you, James, and good morning. I have been in the diagnostics space for the better part of 30 years. The majority of that time was spent with Cytyc Corporation and Hologic. Cytyc was a startup focused on women's health, and specifically cervical cancer screening with the ThinPrep Pap Test. I started at Cytec in January 1997, and over the next 10 years, held various sales and sales manager positions leading to a corporate role as VP of Sales and Marketing in 2004.

謝謝你，詹姆斯，早安。我在診斷領域工作了 30 年的大部分時間。大部分時間都花在 Cytyc Corporation 和 Hologic 上。 Cytyc 是一家專注於女性健康的新創公司，特別是透過 ThinPrep 巴氏檢測進行子宮頸癌篩檢。我於 1997 年 1 月開始在 Cytec 工作，在接下來的 10 年裡，擔任過各種銷售和銷售經理職位，最終於 2004 年擔任公司銷售和行銷副總裁。

ThinPrep became the new standard of care for cervical cytology over this time, representing over 85% of the cervical cancer screening testing market in the United States. When Hologic acquired Cytyc in 2007, I transitioned to President of Hologic Diagnostics, a position I held for three years, and oversaw the acquisitions of Adeza and Third Wave Technologies.

ThinPrep 在此期間成為子宮頸細胞學護理的新標準，占美國子宮頸癌篩檢檢測市場 85% 以上的份額。當 Hologic 於 2007 年收購 Cytyc 時，我轉任 Hologic Diagnostics 總裁，擔任該職位三年，並監督 Adeza 和 Third Wave Technologies 的收購。

Post Hologic, I served as Chief Commercial Officer of Constitution Medical. CMI developed the innovative Bloodhound hematology system for accurate diagnosis of blood-related diseases. CMI was acquired by Roche Diagnostics in 2013.

後Hologic，我擔任憲法醫療首席商務官。 CMI 開發了創新的 Bloodhound 血液學系統，用於準確診斷血液相關疾病。 CMI 於 2013 年被羅氏診斷公司收購。

Before my planned retirement, I served as President and CEO of LipoScience, a diagnostics company, whose NMR LipoProfile test helped better manage patients with increased risk of developing a cardiovascular disease. LipoScience was acquired by LabCorp in 2014.

在計劃退休之前，我曾擔任診斷公司 LipoScience 的總裁兼首席執行官，該公司的 NMR LipoProfile 測試有助於更好地管理患心血管疾病風險增加的患者。 LipoScience 於 2014 年被 LabCorp 收購。

I was introduced to James by a Renalytix Board member, and spent several months evaluating the KidneyIntelX technology, and traveling with Renalytix sales personnel, and meeting with commissions. What became clear to me was not only did KidneyIntelX provide a vital service to doctors and patients, but that with a targeted sales approach, we could achieve a major impact on patient outcomes and the unsustainable healthcare costs that come with late stage kidney disease and dialysis.

Renalytix 董事會成員向 James 介紹了我，並花了幾個月的時間評估 KidneyIntelX 技術，與 Renalytix 銷售人員一起出差，並會見佣金。我清楚地意識到，KidneyIntelX 不僅為醫生和患者提供了重要的服務，而且透過有針對性的銷售方法，我們可以對患者的治療結果以及晚期腎臟病和透析帶來的不可持續的醫療費用產生重大影響。

My experience in the field convinced me to cut my retirement short, and jump in to spearhead this significant opportunity for growth and positively impact patients. I've been very fortunate to have built leading diagnostic sales and marketing teams that have made innovative products widely used and standard of care.

我在該領域的經驗說服我縮短退休時間，並投入這重要的成長機會中，並為患者帶來正面影響。我非常幸運能夠建立領先的診斷銷售和行銷團隊，使創新產品廣泛使用並提高護理標準。

Most importantly though, having launched two family members suffer through dialysis treatment with one ultimately getting a new kidney, I have seen the bad and the really bad in this space. I will think of them often why I'm on this journey, as a motivator and reminder of how important it is, the KidneyIntelX mission that we are working on together.

但最重要的是，兩名家庭成員接受了透析治療，其中一名最終獲得了新的腎臟，我已經看到了這個領域的糟糕和真正糟糕的情況。我會經常想起他們為什麼我踏上這段旅程，作為一種激勵和提醒，讓我們知道我們正在共同努力的 KidneyIntelX 使命是多麼重要。

A few highlights based on my early observations at Renalytix. Number one -- to date, we are rapidly completing the retooling and recruitment of the sales organization to focus on direct-to-primary care sales efforts. Four highly-experienced account executives have accepted offers, and will be onboarded through the remainder of this year. The sales team size will be 14 starting in 2024, with a focus on sales in high diabetes density regions in New York, Texas, Florida, North and South Carolina, and Ohio.

基於我在 Renalytix 的早期觀察的一些亮點。第一——迄今為止，我們正在迅速完成銷售組織的重組和招聘，以專注於直接面向初級保健的銷售工作。四名經驗豐富的客戶經理已接受聘用，並將在今年剩餘時間內入職。從 2024 年開始，銷售團隊規模將達到 14 人，重點關注紐約、德克薩斯州、佛羅裡達州、北卡羅來納州、南卡羅來納州以及俄亥俄州糖尿病高密度地區的銷售。

Two, with our full sales team in place, the most important goal remains assisting our customers and physician offices with consistent direction on how to identify patients that meet the KidneyIntelX FDA-approved indication of use criteria. Since I began, our ordering requisition process is now being streamlined to keep things simple and accurate as possible for our customers and physicians.

第二，隨著我們完整的銷售團隊就位，最重要的目標仍然是協助我們的客戶和醫生辦公室就如何識別符合 FDA 批准的 KidneyIntelX 適應症標準的患者提供一致的指導。自從我開始以來，我們的訂購申請流程正在簡化，以便為我們的客戶和醫生提供盡可能簡單和準確的服務。

Three, we are moving quickly to ready the KidneyIntelX.dkd FDA-authorized test for rollout in the March quarter. Our marketing materials are already quite good, but we are using the FDA launch opportunity to improve messaging to further reflect the unique advantages of KidneyIntelX technology in identifying patients at risk for kidney failure early on.

第三，我們正在迅速採取行動，準備 FDA 授權的 KidneyIntelX.dkd 測試，以便在三月季度推出。我們的行銷資料已經相當不錯，但我們正在利用 FDA 發布的機會來改進訊息傳遞，以進一步體現 KidneyIntelX 技術在早期識別有腎衰竭風險的患者方面的獨特優勢。

Publication of the KidneyIntelX one-year outcomes data, likely this year, should have positive impact on sales. We will also be prioritizing a peer-reviewed publication of KidneyIntelX cost effectiveness on population live testing.

KidneyIntelX 一年結果數據的發布（可能在今年）應該會對銷售產生積極影響。我們還將優先考慮出版經過同行評審的 KidneyIntelX 人群即時測試成本效益出版物。

Four, we began working this summer on more accurate targeting of primary care physicians serving a high concentration of patients with diabetes. Approximately 40% of these patients are likely to have existing chronic kidney disease, and will meet the intended use criteria for KidneyIntelX testing.

第四，我們從今年夏天開始致力於更準確地定位為高濃度糖尿病患者提供服務的初級保健醫生。這些患者中約有 40% 可能患有慢性腎臟病，並且符合 KidneyIntelX 測試的預期使用標準。

This targeting will allow us to go deep in our top target physicians, as opposed to going wide across all clinicians. I believe this will produce more routine ordering patterns from those top targets, which create true believers, and advance prognosis -- believers that are more apt to be repeat orderers of our tests.

這種定位將使我們能夠深入我們的頂級目標醫生，而不是廣泛涵蓋所有臨床醫生。我相信這將從那些頂級目標中產生更多常規排序模式，從而創造真正的信徒，並促進預後——更容易成為我們測試的重複排序者的信徒。

One thing that is abundantly clear particularly since spending time with James and the Renalytix team at the American Society of Nephrology Kidney Week earlier this month, the kidney space is undergoing a wave of innovation and a shift towards preventative medicine. A whole pipeline of new drugs adds promise to improving lives, but also complicates the picture, especially for primary care physicians who will be doing the majority of the deciding when to prescribe, what drugs, et cetera.

自從本月早些時候在美國腎臟病學會腎臟週上與 James 和 Renalytix 團隊一起度過以來，有一點非常清楚：腎臟領域正在經歷一波創新浪潮和向預防醫學的轉變。一系列新藥增加了改善生活的希望，但也使情況變得複雜，特別是對於初級保健醫生來說，他們將負責決定何時開藥、開什麼藥等等。

Particularly at the very business primary care level, this shift to preventative medicine and targeted drug therapy is going to require a KidneyIntelX gateway that can capture the current patient biology with blood biomarkers, and provide a simple accurate result that any primary care physician can use regardless of experience or training.

特別是在商業初級保健層面，向預防醫學和靶向藥物治療的轉變將需要一個KidneyIntelX 網關，該網關可以通過血液生物標誌物捕獲當前患者的生物學情況，並提供簡單準確的結果，任何初級保健醫生都可以使用經驗或訓練。

Thank you for your time today, and I look forward to sharing more details with you all in the future. I would now like to turn the call over to Tom McLain, our President.

感謝您今天抽出寶貴的時間，我期待著將來與大家分享更多詳細資訊。我現在想把電話轉給我們的總統湯姆·麥克萊恩。

Thank you, Howard, and good morning. When we launched KidneyIntelX, our commitment was to be positioned to offer testing to patients regardless of their ability to pay. While more than half of patients eligible for testing have Medicare fee-for-service, or Medicare Advantage coverage, achieving that requires broad coverage and billing programs that meet patient needs.

謝謝你，霍華德，早安。當我們推出 KidneyIntelX 時，我們的承諾是為患者提供檢測，無論他們的支付能力如何。雖然超過一半有資格接受檢測的患者擁有 Medicare 按服務收費或 Medicare Advantage 承保範圍，但要實現這一目標，需要廣泛的承保範圍和滿足患者需求的計費計劃。

For traditional Medicare, we continue to see claim payment from National Government Services, the Medicare contractor responsible for payment of claims for tests that are run in our New York laboratory. NGS began paying under individual claim review for testing dates as of July 2022. Renalytix has also requested a local coverage determination, or LCD, from NGS. Driven by FDA approval in June, NGS formally began its LCD review during fiscal quarter one. During the LCD review process, NGS suspended claims payment.

對於傳統的醫療保險，我們繼續看到國家政府服務部的索賠付款，該醫療保險承包商負責支付在我們紐約實驗室進行的測試的索賠。自 2022 年 7 月起，NGS 開始根據個人索賠審查支付測試日期的費用。在 6 月 FDA 批准的推動下，NGS 在第一財季正式開始 LCD 審查。在LCD審查過程中，NGS暫停了理賠付款。

As part of the 21st Century Cures Act, Medicare contractors are mandated to base an LCD on robust evidence. Part of that process is to convene subject matter experts, when necessary, to review the peer reviewed published literature, and to provide input that plays a role in the development of a future coverage decision.

作為《21 世紀治癒法案》的一部分，醫療保險承包商必須以強有力的證據為基礎制定 LCD。這個過程的一部分是在必要時召集主題專家來審查同行評審的已發表文獻，並提供在未來報道決策的製定中發揮作用的意見。

NGS held its CAC meeting to review KidneyIntelX on August 28. The committee review included nephrologists and primary care physicians from the NGS region who answered pre-defined questions about KidneyIntelX testing. The transcript from that discussion has been published on the NGS website. In general, we believe the comments supported the quality of the published evidence, and we noted the primary care clinician concluded that KidneyIntelX testing would be beneficial in caring for early-stage diabetic kidney disease patients.

NGS 於 8 月 28 日召開了 CAC 會議，對 KidneyIntelX 進行審查。該討論的記錄已發佈在 NGS 網站上。總的來說，我們相信這些評論支持已發表證據的質量，並且我們注意到初級保健臨床醫生得出的結論是 KidneyIntelX 測試將有益於護理早期糖尿病腎病患者。

Following the CAC. meeting, the NGS medical directors consider the CAC member observations and the peer-reviewed literature, and also evaluate evidence of utilization and outcomes benefits. When a coverage decision is reached, they draft a coverage policy, submitted to CMS for review and comment, and then schedule it for review at an open public meeting.

遵循 CAC。在會議上，NGS 醫學主任會考慮 CAC 成員的觀察結果和同行評審的文獻，並評估使用證據和結果效益。達成承保決定後，他們會起草承保政策，提交給 CMS 進行審查和評論，然後安排在公開會議上進行審查。

As an update, NGS resumed payment for claims in November. The next open meeting is expected in February 2024.

作為更新，NGS 在 11 月恢復了索賠付款。下一次公開會議預計將於 2024 年 2 月舉行。

During NGS LCD review period, we also submitted claims to First Coast Options, the Medicare contractor responsible for payment of claims for tests run in our Tampa, Florida laboratory. First Coast began paying for submitted claims in October 2023. We will continue to submit claims to both NGS and First Coast.

在 NGS LCD 審查期間，我們還向 First Coast Options 提交了索賠，該承包商是 Medicare 承包商，負責支付在我們佛羅裡達州坦帕實驗室進行的測試的索賠。 First Coast 於 2023 年 10 月開始為提交的索賠付款。

Turning now to private payers, with FDA approval in June 2023, we have continued to expand coverage for testing in our key sales markets. We continue to see payment for KidneyIntelX testing from Medicare Advantage plans at Medicare CLFS's published price of $950. We are also being paid by other private payers in our key sales regions, including New York, Illinois, Texas, Florida, and the Carolinas.

現在轉向私人付款人，隨著 FDA 於 2023 年 6 月批准，我們繼續擴大主要銷售市場的測試覆蓋範圍。我們繼續看到 Medicare Advantage 計劃以 Medicare CLFS 的公佈價格 950 美元支付 KidneyIntelX 測試的費用。我們的主要銷售地區的其他私人付款人也向我們付款，包括紐約、伊利諾伊州、德克薩斯州、佛羅裡達州和卡羅來納州。

Our focus is on expanding coverage contracts in these regions, building on our successes, including EmblemHealth, BlueCross BlueShield, Illinois, and BlueCross BlueShield of Texas.

我們的重點是在我們的成功基礎上擴大這些地區的承保合同，包括安保健康保險、伊利諾伊州的 BlueCross BlueShield 和德克薩斯州的 BlueCross BlueShield。

As a result of all of these accomplishments, our policy is to accept all patient insurances. To date, almost 90% of patients tested have an out-of-pocket obligation ranging from $0 to $20. In order to assure that patients are not surprised by high deductible plans or out-of-network charges, we do not process tests with an estimated patient out-of-pocket costs greater than $50 without patient consent.

由於所有這些成就，我們的政策是接受所有患者保險。迄今為止，幾乎 90% 的接受測試的患者都有 0 至 20 美元的自付費用。為了確保患者不會對高免賠額計劃或網絡外費用感到驚訝，未經患者同意，我們不會處理估計患者自付費用超過 50 美元的測試。

While this does not happen often, we hope to avoid office and patient dissatisfaction with this policy. We're also able to offer a generous patient assistance program to patients who meet specified financial criteria.

雖然這種情況並不常發生，但我們希望避免辦公室和病人對此政策的不滿。我們也能夠為符合特定財務標準的患者提供慷慨的患者援助計劃。

While NGS payment was suspended during Q1, we are encouraged that payment has resumed in Q2, and I look forward to keeping you updated on our progress towards a local coverage determination on future calls.

雖然 NGS 付款在第一季暫停，但令我們感到鼓舞的是，付款已在第二季度恢復，我期待向您通報我們在未來通話中確定本地覆蓋範圍的最新進展。

I would now like to turn the call over to James Sterling, our Chief Financial Officer. James?

我現在想把電話轉給我們的財務長詹姆斯·斯特林。詹姆士？

Thank you, Tom. Today, we issued the financial results for the first quarter of fiscal year 2024, which ended September 30, 2023. 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，湯姆。今天，我們發布了截至 2023 年 9 月 30 日的 2024 財年第一季的財務業績。我將在這裡討論的數字是基於我們的公認會計準則財務數據，並以美元報價，美元是我們的報告貨幣。

For the first quarter, we recorded revenue of $460,000 compared to $970,000 in the first quarter of the prior fiscal year. Overall testing volume remained steady, with total tests of 1,297, of which 56% were billable -- which is a slightly higher total test volume than in both the prior quarter, as well as the prior year fiscal first quarter.

第一季的營收為 46 萬美元，而上一財年第一季的營收為 97 萬美元。整體測試量保持穩定，總測試量為 1,297 次，其中 56% 是收費的——這比上一季和去年第一財季的總測試量略高。

As previously communicated, certain study related tests at Mount Sinai are no longer billable following the transition from Mount Sinai as payer to traditional commercial insurance billing. In the year-ago period, 82% of our testing was billable. We expect the billable percentage to increase as commercial testing becomes a higher portion of the total in the quarters ahead.

正如之前所傳達的，在從西奈山作為付款人過渡到傳統商業保險計費之後，西奈山的某些與研究相關的測試不再收費。去年同期，我們 82% 的測試是收費的。我們預計，隨著商業測試在未來幾季佔總測試的比例越來越高，計費百分比將會增加。

Revenue reported in the quarter does not include tests billed to certain payers that are not yet being recognized as revenue until there is a demonstrated history of payment from such payers. This represented nearly 250 tests in the first quarter, or about 34% of the billable total. This also now includes testing built to NGS Medicare until regular payment resumes, pending the outcome of the local coverage determination process.

本季度報告的收入不包括向某些付款人收取的測試費用，這些付款人在有證據表明這些付款人的付款歷史之前尚未確認為收入。這意味著第一季進行了近 250 次測試，約佔計費總數的 34%。現在還包括針對 NGS Medicare 構建的測試，直到恢復定期付款為止，等待當地承保確定流程的結果。

Operating expenses for the first quarter were $8.8 million on a GAAP basis, significantly reduced from the $12 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，第一季營運費用為 880 萬美元，較上年同期的 1,200 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。

More recently, we've taken a sharper knife to operating costs, and implemented a plan to reduce payroll expense by over 35% year-over-year, and total SG&A by more than 30% year-over-year, all while preserving the sales capacity to demonstrate revenue growth in the quarters ahead. Our focus now on key sales regions, combined with completion of milestones already discussed, allows us to lighten or eliminate spend in several areas, including clinical trial work. We will see the results of these changes starting in the immediate quarters ahead, and continuing into the next fiscal year.

最近，我們對營運成本採取了更鋒利的態度，並實施了一項計劃，將工資費用同比減少 35% 以上，SG&A 總額同比減少 30% 以上，同時保持銷售能力表明未來幾個季度的收入增長。我們現在的重點是關鍵銷售區域，再加上已經討論過的里程碑的完成，使我們能夠減輕或消除多個領域的支出，包括臨床試驗工作。我們將在接下來的幾個季度看到這些變化的結果，並持續到下一個財年。

Net loss for the first quarter of fiscal 2024 was $10.1 million, or $0.11 per share, inclusive of a foreign currency gain of $289,000. This was down from a net loss of about $12 million, or $0.16 per share, for the first quarter of fiscal '23, which included a foreign currency gain of $1.7 million.

2024 財年第一季的淨虧損為 1,010 萬美元，即每股 0.11 美元，其中包括 289,000 美元的外匯收益。這低於 23 財年第一季約 1,200 萬美元（即每股 0.16 美元）的淨虧損，其中包括 170 萬美元的外匯收益。

We ended the first quarter with approximately $13.9 million of cash as of September 30, 2023. We are actively engaged in financing discussions and are hopeful to close a transaction, which coupled with our cost reduction activities, is expected to extend our cash runway into calendar 2026.

截至2023 年9 月30 日，我們第一季末擁有約1,390 萬美元現金。曆中2026 年。

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）

Please stand by while we compile the Q&A roster.

我們正在整理問答名單，請稍候。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey guys. Thank you for the questions. And Howard, it's nice to hear from you. Thanks for providing your background. Maybe if we could -- there's a lot of ground to cover. So, I know, Howard, you talked about the initial states that you're targeting.

大家好。謝謝你的提問。霍華德，很高興收到你的來信。感謝您提供您的背景。也許如果我們可以的話——還有很多工作要做。所以，我知道，霍華德，你談到了你的目標初始狀態。

Just maybe for folks that might have missed everything that you ran through, can you just remind us what the territories are? And then I know you had a sales team on the ground previously. Are you basically looking to optimize that commercial team of 14? So I'm just curious where you are in terms of making potential changes to that team?

也許對於那些可能錯過了您所經歷的一切的人來說，您能提醒我們這些領土是什麼嗎？然後我知道您之前有一個銷售團隊。您基本上是在尋求優化 14 人的商業團隊嗎？所以我只是好奇你在對該團隊進行潛在改變方面處於什麼位置？

Thank you, Mark. So initially, what we did is we made some performance related changes a couple of months back and started re-recruiting for those opportunities. As stated, the primary areas of focus for us right now will be, on a move-forward basis, New York, Texas, Florida, North and South Carolina, and Ohio.

謝謝你，馬克。因此，最初，我們所做的是幾個月前進行了一些與績效相關的改變，並開始重新招募這些機會。如前所述，我們目前的主要關注領域將是紐約州、德克薩斯州、佛羅裡達州、北卡羅來納州、南卡羅來納州以及俄亥俄州。

We currently have 10 folks in the sales organization, most who joined us in August of this of this year. And we continue to work and develop those folks to be key contributors on a move-forward basis. Internally as part of some of those performance-related terminations, we have been actively recruiting new folks as well. And again, those are the four folks that will be starting between now and the end of this calendar year.

目前，我們的銷售團隊有 10 名員工，其中大多數是今年 8 月加入我們的。我們將繼續努力並培養這些人成為未來的關鍵貢獻者。在內部，作為一些與績效相關的解僱的一部分，我們也一直在積極招募新員工。再說一次，這四個人將從現在到今年年底開始工作。

And I would say the biggest difference of what we were really looking for is, I like to say, we were looking for the top 10 percenters. And what I mean by that is finding folks that have been in the primary care space before, as well as calling on specialists. But more importantly, that have distinguished themselves within their organizations as prior peak club winners -- top producers that whatever category that they were challenged with. So I just feel like we've elevated the game with these new folks that will be starting between now and the end of the year.

我想說的是，我們真正尋找的最大區別是，我們正在尋找前 10% 的人。我的意思是找到以前在初級保健領域工作過的人，並拜訪專家。但更重要的是，這些人在他們的組織中脫穎而出，成為以前的巔峰俱樂部獲勝者——無論他們面臨什麼類別的挑戰，都是頂級製作人。所以我覺得我們已經與這些新人一起提升了遊戲水平，這些新人將從現在開始到今年年底。

Okay. And I know you guys were previously working with EVERSANA. Is that partnership still active? Or how should we think about that going forward?

好的。我知道你們之前曾與 EVERSANA 合作過。這種夥伴關係仍然活躍嗎？或者我們該如何思考未來的發展？

Yes. Hey Mark, it's James. That partnership is still active, although Howard obviously changes the game. When we originally signed up with EVERSANA, we didn't have Howard, but the partnership with EVERSANA will continue.

是的。嘿馬克，我是詹姆斯。儘管霍華德顯然改變了比賽，但這種夥伴關係仍然活躍。當我們最初與EVERSANA簽約時，我們沒有霍華德，但與EVERSANA的合作關係將會繼續。

Excellent. Okay. I could use maybe a little bit of help to understand why the payment from NGS was stopped. And then I believe it's now resumed. Good to see the payment here in November. But maybe can you provide a -- maybe just an update as to why the payment was suspended? Did it have something to do with the CAC and the LCD discussion?

出色的。好的。我可能需要一點幫助來理解為什麼 NGS 的付款被停止。然後我相信現在已經恢復了。很高興看到十一月份的付款。但也許你可以提供一個——也許只是更新付款被暫停的原因？這與 CAC 和 LCD 的討論有關嗎？

It's all you, Tom.

都是你，湯姆。

Thanks, James. Mark, yes, so we were notified when the LCD process was initiated. This was around the timing of the CAC meeting that they would not continue payment of claims while they were considering all of the evidence, the medical directors, comprehensively with regard to the appropriateness of support for medical necessity overall.

謝謝，詹姆斯。馬克，是的，所以當 LCD 流程啟動時我們收到了通知。這是在 CAC 會議召開期間，他們在考慮所有證據時，即醫療主任，全面考慮對整體醫療必要性支持的適當性，他們不會繼續支付索賠。

So when we received that -- we appreciated receiving that communication from NGS. We have not heard from NGS as to why they have resumed payment of testing effective November 1. But we would understand that that had to factor in what they heard during the CAC meeting, and also the evidence reviewed that the medical directors have done as a group.

因此，當我們收到該訊息時，我們很高興收到 NGS 的訊息。我們還沒有從 NGS 獲悉他們為什麼從 11 月 1 日起恢復支付檢測費用。團體。

Okay, great. And then it is very nice to see First Coast come on. Looks like they are paying claims. Maybe could you just remind me, if you're pursuing an LCD with First Coast, and what timing might look like there?

好的，太好了。很高興看到第一海岸上場。看起來他們正在支付索賠。也許您可以提醒我一下，如果您正在與 First Coast 合作購買液晶顯示器，那麼時機可能是什麼？

We knew with First Coast, that for tests like KidneyIntelX, that they have entered into a process where they pay claims and don't require an LCD. We have met with the medical directors to go through the evidence for KidneyIntelX before we submitted those additional claims. We will be meeting with them again during the first quarter for an update on FDA, and all of the published evidence that has been developed since our meeting earlier this year.

我們從 First Coast 了解到，對於像 KidneyIntelX 這樣的測試，他們已經進入了支付索賠且不需要 LCD 的流程。在提交這些額外索賠之前，我們已經與醫療主管會面，並仔細檢查了 KidneyIntelX 的證據。我們將在第一季再次與他們會面，以了解 FDA 的最新情況，以及自今年稍早的會議以來已發布的所有證據。

And as part of that meeting, we will discuss whether going forward with the LCD process is going to be necessary in this case, or whether we can just continue to operate under the model that we have right now, where they're paying for our claims within the the seven day window that's typical for payment with Medicare contractors.

作為該會議的一部分，我們將討論在這種情況下是否有必要繼續推進 LCD 工藝，或者我們是否可以繼續在我們現在的模式下運營，他們為我們的產品付費在7 天窗口內索賠，這是醫療保險承包商付款的典型做法。

Okay, great. And maybe last question for me. I know you don't need it, but it might be nice to have to have the national coverage determination. Can you just clarify the comments you made? Have you submitted for that? And can you just maybe brief us on any conversations you've had, with respect to both the filing and perhaps the expected timing of obtaining an NCD?

好的，太好了。也許是我的最後一個問題。我知道您不需要它，但擁有全國覆蓋範圍的確定可能會很好。你能澄清一下你發表的評論嗎？你已經提交了嗎？您能否向我們簡要介紹一下您就申請以及獲得 NCD 的預期時間進行的任何對話？

So Mark, I would refer you -- as you know, there is a rule moving forward that would guide the coverage of breakthrough technologies by Medicare at a national level. This is for any medical device, so anything approved through CDRH.

馬克，我想向您推薦——正如您所知，未來有一項規則將指導醫療保險在國家層面涵蓋突破性技術。這適用於任何醫療設備，包括透過 CDRH 批准的任何設備。

In that rule, Medicare clearly stated that with regard to diagnostic tests, that is their preference, that diagnostic tests are covered through the local coverage determination process, through the MAC.And that they believed that the MAC was the most effective way for those coverage decisions to be reached.

在該規則中，Medicare 明確表示，關於診斷測試，這是他們的偏好，診斷測試透過 MAC 的本地承保確定流程進行承保。

However, diagnostic tests that were facing challenges at the local level, or diagnostic tests that had national Medicare policy implications, that they could be considered at a national level. So the typical pathway for a test like kidney Intelex is to be LCD.

然而，在地方層級面臨挑戰的診斷測試，或對國家醫療保險政策有影響的診斷測試，可以在國家層級考慮。因此，像腎臟 Intelex 這樣的測試的典型途徑是 LCD。

That said, as you correctly recall, because of the delays that we had faced with NGS, we had met with CMS nationally, and notified them that we intended to apply for a national coverage determination. And why? Because of what we felt was a very slow movement forward with NGS.

也就是說，正如您正確記得的那樣，由於我們在 NGS 方面遇到了延誤，我們在全國範圍內與 CMS 進行了會面，並通知他們我們打算申請全國範圍內的覆蓋範圍確定。為什麼？因為我們認為 NGS 的進展非常緩慢。

We're now going back to CMS because NGS does appear to be moving forward with the LCD process. To understand with that development, will they consider the review of our application for a national coverage determination. That's a lot packed into a few sentences. Did that all follow, or do you have any follow-up questions on that note?

我們現在回到 CMS，因為 NGS 似乎確實在推進 LCD 流程。為了了解這項進展，他們是否會考慮審查我們的全國覆蓋範圍申請申請。幾句話就包含了許多內容。一切都這樣了嗎？

No. Tom, I really appreciate that. I followed everything, and I appreciate all of those updates. So I will hop back in the queue. Thanks, guys.

不，湯姆，我真的很感激。我關注了一切，並感謝所有這些更新。所以我會跳回到隊列中。多謝你們。

Okay.

好的。

Paul Stewardson, Stifel.

保羅·斯圖爾森，斯蒂菲爾。

Yes, good morning. Just calling in for Dan Arias. I'm just wondering if you can give some color on what to expect once this Atrium Health Wake Forest health system gets online next month with the integration?

是的，早安。剛剛打電話給丹·阿里亞斯。我只是想知道，一旦 Atrium Health Wake Forest 醫療系統下個月上線並整合後，您是否可以給出一些預期的結果？

Can you talk about how that's going to roll out in terms of, you know, reimbursement rates initially and over the course of the next few quarters, as well volumes? And if there will be a bit of a pause, or what we can expect to see for the next few quarters as that kicks in?

您能否談談將如何在最初的報銷率和未來幾季的報銷率以及數量方面展開？是否會出現一些暫停，或者我們預計在接下來的幾個季度中會看到什麼？

So the good news with Atrium Wake Forest is they have a superb integrated program from population health, and primary care, and other physicians. We really view it as a model as for how care should be delivered and supported, especially on the preventative medicine side. So KidneyIntelX slots right into that system, and the other good news is that we've spent the last couple of years with the leading clinicians at Atrium Wake Forest using KidneyIntelX in an IRB controlled real-world evidence program. So they've used KidneyIntelX in the system, in this care pathway, with physicians looking at risk in diabetic kidney disease.

因此，Atrium Wake Forest 的好消息是，他們擁有一個來自人口健康、初級保健和其他醫生的出色綜合計劃。我們確實將其視為如何提供和支持護理的典範，特別是在預防醫學方面。因此，KidneyIntelX 可以直接插入該系統，另一個好消息是，過去幾年我們與 Atrium Wake Forest 的領先臨床醫生一起在 IRB 控制的真實世界證據計劃中使用 KidneyIntelX。因此，他們在系統中的護理途徑中使用了 KidneyIntelX，讓醫生專注於糖尿病腎病變的風險。

And I believe that we've passed through 1600 patients tested, and these results will be published. We've already seen, obviously, the preview of this, and we're very pleased with the fact that KidneyIntelX appears to be performing very similar to the real-world evidence program, which is completely independent in a different area of the country, in a different system as Mount Sinai.

我相信我們已經對 1600 名患者進行了測試，這些結果將會被公佈。顯然，我們已經看到了這一點的預覽，並且我們非常高興 KidneyIntelX 的表現似乎與現實世界的證據計劃非常相似，該計劃在該國的不同地區是完全獨立的，在與西奈山不同的系統中。

So this is prima facie evidence for us that KidneyIntelX is doing the job in the care pathway to assess risk and help manage disease. And because Wake Forest is now familiar with KidneyIntelX, we would anticipate a relatively smooth rollout across certainly primary care treating physicians throughout the system.

因此，這是我們的初步證據，表明 KidneyIntelX 正在護理途徑中評估風險並幫助管理疾病。由於維克森林大學現在熟悉 KidneyIntelX，我們預計整個系統的初級保健治療醫生將相對順利地推出。

The integration of KidneyIntelX in the Wake Forest Epic system is complete, and should be completed in the Atrium Epic system in December. Commercial testing will start shortly thereafter.

KidneyIntelX在Wake Forest Epic系統中的整合已經完成，預計12月在Atrium Epic系統中完成。不久後將開始商業測試。

In terms of the reimbursement, we are continuing to contract with multiple insurance companies, and obviously with Medicare, Medicaid, at the $950 Medicare-prescribed price. We will not contract off of that price at the moment. So you can expect that to be the price that we're moving forward with.

在報銷方面，我們繼續與多家保險公司簽訂合同，顯然是與 Medicare、Medicaid 簽訂合同，按照 Medicare 規定的價格 950 美元。目前我們不會取消該價格。因此，您可以預期這將是我們正在推進的價格。

But we're very excited about Atrium Wake Forest. It is a significant system, and having the data that's been generated internally, we think that gives us and the clinicians a lot of experience to move forward with KidneyIntelX on a broad basis in calendar 2024.

但我們對 Atrium Wake Forest 感到非常興奮。這是一個重要的系統，並且擁有內部產生的數據，我們認為這為我們和臨床醫生在 2024 年廣泛推進 KidneyIntelX 提供了豐富的經驗。

We're not going to project the uptake in that, let's let's see how it goes. But again, this is going to be a coordinated effort, so that we make sure we have proper support from the Renalytix side, as well as the internal support, which is being generated from population health and other leading physicians within Wake Forest.

我們不會預測這方面的吸收情況，讓我們看看情況如何。但同樣，這將是一項協調一致的努力，以便我們確保我們得到 Renalytix 的適當支持，以及來自人口健康和維克森林大學內其他領先醫生的內部支持。

Tom, would you like to comment on that any further?

湯姆，你想對此發表進一步評論嗎？

No, I think you covered that very well. And just to reiterate that because of the study that they have done across primary care within the Wake Forest and the Atrium Health systems, they do have experience with that. They understand what it can do in terms of pharmacy management, appropriate referrals, patient engagement, so that that is something that they have firsthand knowledge to take advantage of, as they are ready to expand our testing broadly within the health system. So we're very excited about it.

不，我認為你講得很好。只是重申一下，由於他們在維克森林大學和 Atrium 衛生系統內的初級保健領域所做的研究，他們確實有這方面的經驗。他們了解它在藥房管理、適當轉診、患者參與方面的作用，因此他們擁有可以利用的第一手知識，因為他們準備在衛生系統內廣泛擴展我們的測試。所以我們對此感到非常興奮。

And I'd just like to add one thing. Several years ago, we made the decision to invest heavily in real-world utility and real-world outcomes data, especially since the reimbursement paradigm is moving towards outcomes data, not just utility data. And so we've invested heavily, for example, in the Mount Sinai Health System real-world evidence program. We've invested heavily in the Atrium Wake Forest real-world evidence program. All of this is now starting to bear fruit.

我只想補充一件事。幾年前，我們決定大力投資現實世界的效用和現實世界的結果數據，特別是因為報銷範式正在轉向結果數據，而不僅僅是效用數據。因此，我們在西奈山衛生系統真實世界證據計劃等方面投入了大量資金。我們在 Atrium Wake Forest 現實世界證據計劃上投入了大量資金。所有這一切現在都開始結出碩果。

We're having multiple publications come out on that real-world evidence. This real-world evidence is a critical part of establishing a broader reimbursement. And obviously, this real-world evidence is going to help in terms of generating adoption with clinicians.

我們已經發布了多篇關於現實世界證據的出版品。這些現實世界的證據是建立更廣泛報銷的關鍵部分。顯然，這些現實世界的證據將有助於臨床醫師的採用。

It takes time. It takes a long time to get this done, but we've done all of the fundamental work leading into calendar 2024, to make sure that we do have an extensive risk assessment program throughout the atrium workforce system to benefit patients in need. So beginning to bear fruit now off of the investments that we've made going into this real-world evidence core part of our program.

這需要時間。完成這項工作需要很長時間，但我們已經完成了 2024 年之前的所有基礎工作，以確保我們在整個心房勞動力系統中擁有廣泛的風險評估計劃，以使有需要的患者受益。因此，我們對現實世界證據核心部分的投資現在開始結出碩果。

That's very helpful. I really appreciate the color. Just one more from us. In terms of the growth outlook that was provided last quarter, could you just touch on what you see happening in the near term? In terms of, you mentioned, the sales team is still being built out towards those objectives.

這非常有幫助。我真的很欣賞這種顏色。我們只剩下一件事了。就上季提供的成長前景而言，您能否談談您認為近期會發生什麼？就您所提到的而言，銷售團隊仍在朝著這些目標進行建立。

What are you kind of expecting to see, just directionally, sequentially, through the fiscal year? You know, the cadence from 1Q to 2Q in terms of volume and so forth, Is that something that you're looking for a step-up, or waiting a little bit more towards the back half as we wait for the sales team to kind of kick in to full gear?

您希望在整個財年中按順序、方向性地看到什麼？您知道，從數量等方面來看，從第一季到第二季的節奏，是您正在尋求提升的東西，還是在我們等待銷售團隊的過程中，在後半部分等待更多一點全力以赴？

Okay. Yes. So going into calendar 2024, we'd like to see a step-up. And equally as important, we'd like to see growing evidence of commercial traction in multiple areas. So right now, with a reduced cost structure, with market conditions the way they are, the critical objective for the remainder of fiscal '24 is to demonstrate commercial proof of concept in all of the key markets that we have targeted.

好的。是的。因此，進入 2024 年，我們希望看到進步。同樣重要的是，我們希望看到越來越多的證據表明多個領域的商業吸引力。因此，目前，在成本結構降低、市場狀況保持不變的情況下，24 財年剩餘時間的關鍵目標是在我們瞄準的所有關鍵市場中展示概念的商業證明。

It's very focused -- very specific territories -- in territories where we have extensive reimbursement, which again has been our goal from the very beginning, we're starting to see territories where we have over 90% form of insurance payment against patients within the indicated use of KidneyIntelX.

它非常有針對性——非常具體的地區——在我們有廣泛報銷的地區，這也是我們從一開始的目標，我們開始看到我們對患者進行超過 90% 形式的保險支付的地區。 KidneyIntelX。

With Howard's sales force now coming online, which will be full force and effective going into the March quarter of next year; with groups like Atrium Wake Forest coming online; with additional data publication, this should all move to stimulate additional testing volume in these territories. That's what we're focused on.

霍華德的銷售團隊現已上線，並將在明年三月的季度全面發揮作用； Atrium Wake Forest 等團體即將上線；隨著更多數據的發布，這一切都應該會刺激這些地區的更多測試量。這就是我們關注的重點。

And again, I mentioned this early on, because we've crossed regulatory thresholds, because we've crossed data production thresholds, we're now in a position where we can realign the resources in the company significantly towards sales and marketing. Away from development, regulatory, other activities which require a significant investment and take a long time, we've now crossed those thresholds.

再說一次，我很早就提到過這一點，因為我們已經跨越了監管門檻，因為我們已經跨越了數據生產門檻，我們現在可以將公司的資源顯著重新調整到銷售和行銷方面。除了需要大量投資和耗時的開發、監管和其他活動之外，我們現在已經跨越了這些門檻。

So really this is very much a sales and marketing game. We are very much focused on how can we drive sales in the short term. And certainly all of the milestones that we've talked about should stimulate that we're not going to forecast, but I am I am optimistic about 2024. Now we need to prove it.

所以這實際上是一個銷售和行銷遊戲。我們非常關注如何在短期內推動銷售。當然，我們討論過的所有里程碑都應該刺激我們不會預測的事情，但我對 2024 年持樂觀態度。

Understood. Thanks for taking the questions.

明白了。感謝您提出問題。

Randy Baron, Pinnacle.

蘭迪巴倫，巔峰之作。

Good morning. I have one question for James, and then one for Howard.

早安.我有一個問題想問詹姆斯，還有一個問題想問霍華德。

James, I just would love you to drill into the first bullet point that you addressed, which is the fundraise. I mean, you said you're going to hopefully be funded through calendar '26. I'm just curious what that means in terms of directionally? As much as you can give us -- the size of the range, or range for the size of the range -- what your cash burn is going to be per quarter, assuming no ramp in sales, et cetera? Whatever you can share.

詹姆斯，我只是希望你能深入探討你提到的第一個要點，即籌款。我的意思是，你說過你希望在 26 日曆年獲得資助。我只是好奇這在方向上意味著什麼？只要你能告訴我們——範圍的大小，或範圍大小的範圍——假設銷售額沒有成長等等，你每季的現金消耗是多少？有什麼可以分享的。

And Howard, my question for you, now that you're in the company is, as you've looked through the business, and just in a layman's perspective, what do you think the number one hurdle that Renalytix needs to overcome to achieve sales is, and why has that not been overcome yet?

霍華德，我想問你的問題是，既然你已經加入了公司，你已經了解了整個業務，從外行的角度來看，你認為 Renalytix 實現銷售需要克服的首要障礙是什麼？還沒被克服呢？

And I get you're scaling the sales force, et cetera, but any kind of anecdotal stuff you can give us, or how that could change going forward would be helpful. Thank you.

我知道您正在擴大銷售隊伍，等等，但是您可以向我們提供的任何軼事，或者未來如何改變這種情況都會有所幫助。謝謝。

So, Randy, thanks. Compound question. We're in discussions to raise funding. It's a very, very difficult market, as you know, and as everybody knows. Our goal is to put a balance sheet, which will be largely focused on commercial efforts in place before the end of the year.

那麼，蘭迪，謝謝。複合問題。我們正在討論籌集資金。如你所知，也眾所周知，這是一個非常非常困難的市場。我們的目標是在年底前製定一份資產負債表，其中主要關注商業工作。

And we have significant players, institutional players, at the table in discussions to do that. I'm not going to characterize that, because we're in the middle of the process, but we are looking at a number of options and obviously, we'll do everything that we can to maximize the value in that raise process.

我們有重要的參與者、機構參與者參與討論以實現這一目標。我不會描述這一點，因為我們正處於這個過程的中間，但我們正在考慮許多選擇，顯然，我們將盡一切努力在融資過程中最大化價值。

But again, very difficult market. Concentration on really going after the cost basis has been helpful, and we will continue to do that as necessary in 2024, to extend the runway as far as possible. 2026 is an aspiration. It's based on a model we've created with a cost reductions and a capital financing. And let's see how it goes through the remainder of the year, but I'm optimistic that we get there.

但同樣，市場非常困難。專注於真正追求成本基礎是有幫助的，我們將在 2024 年根據需要繼續這樣做，盡可能延長跑道。 2026年是一個願望。它基於我們透過降低成本和資本融資所創建的模型。讓我們看看今年剩下的時間情況如何，但我對我們實現這一目標感到樂觀。

And just on that note, James, before Howard goes, what do you think directionally? Not to a number, but just directionally, how much lower is cash burn going with all -- I mean, if I pencil out the math that OJ talked about, like how much lower? Does it go to $6 million? Does it go to $5 million a quarter? Does it go to $2 million? Just directionally.

就這一點而言，詹姆斯，在霍華德離開之前，你的方向是什麼？不是一個數字，而是一個方向，所有的現金消耗會降低多少——我的意思是，如果我用鉛筆寫下 OJ 談到的數學，會降低多少？會達到600萬美元嗎？每季會達到 500 萬美元嗎？會達到200萬美元嗎？只是定向而已。

Yes, OJ, you want to you want to address it?

是的，OJ，你想解決這個問題嗎？

Yes, sure. So speaking, generally, we are working towards a goal of $3 million to $5 million cash burn quarterly by the end of this fiscal year, and getting down to $1 million to $2 million quarterly by the end of fiscal '26 to give you a sense of what we're working on.

是的，當然。因此，總的來說，我們正在努力實現到本財年結束時每季度現金消耗300 萬美元到500 萬美元的目標，並在26 財年結束時每季度減少到100 萬到200 萬美元，讓您有一個感覺我們正在做的事情。

And just so I'm clear, that would assume de minimis sales growth? Or what does that assume in the sales line to get to $1 million by 2026?

我很清楚，這會假設銷售成長微乎其微嗎？或是 2026 年銷售額達到 100 萬美元的假設是什麼？

It assumes some reasonable sales growth in addition to the cash and the cost reductions that we've been talking about.

除了我們一直在談論的現金和成本降低之外，它還假設了一些合理的銷售成長。

Okay. And Howard, I'd love your take on kind of why sales haven't happened and what you think is changing?

好的。霍華德，我想聽聽您對為什麼銷售沒有發生以及您認為正在發生什麼變化的看法？

Randy, thank you for the question. Obviously, spending some time in the field in the summer, and certainly since I've come on board of full-time, I think it really comes down to one thing. It's been a challenge at the clinician level to identify patients that meet our criteria.

蘭迪，謝謝你的提問。顯然，夏天在這個領域花了一些時間，當然，自從我開始全職工作以來，我認為這實際上可以歸結為一件事。識別符合我們標準的患者一直是臨床醫生面臨的挑戰。

And what's a little bit unique about the situation is not only do we require certain features to be on the requisition form for processing the tests, but we have a very targeted set of patients that we're looking for. And what I've been really impressed with is how quickly the clinicians get our message, and why it's important, and what KidneyIntelX can do for them.

這種情況的獨特之處在於，我們不僅要求在處理測試的申請表上包含某些特徵，而且我們正在尋找一組非常有針對性的患者。令我印象深刻的是臨床醫生能如此迅速地獲取我們的信息，為什麼它很重要，以及 KidneyIntelX 可以為他們做什麼。

But their eyes kind of glaze over when you start talking about these are the patients that we need to find. And a lot of it is in their systems, it's just finding the right person that can extract that. So that was sort of like an early on finding that that I saw very, very early on.

但當你開始談論這些是我們需要找到的病人時，他們的眼神就變得呆滯了。其中許多都在他們的系統中，只是找到可以提取這些內容的合適人選。所以這有點像我很早就看到的早期發現。

So we've been trying different tactics with targeted practices to kind of find that champion. And I think one of the first things we've done is as we start converting new offices, we let them know that there's some skin in the game they have to have here. There's some sweat equity, if this is going to work, finding those patients is actually paramount. And we've been giving them some additional things that they can do to make that process similar.

因此，我們一直在嘗試不同的策略和有針對性的實踐，以找到冠軍。我認為我們所做的第一件事就是當我們開始改造新辦公室時，我們讓他們知道他們必須在這裡擁有一些好處。如果這要起作用，找到這些病人實際上是最重要的。我們已經為他們提供了一些額外的事情，讓他們可以做一些類似的事情。

So that to me was one of the biggest hurdles in the past. It's still an ongoing project. We will continue to hone on over time, but I think we've made some tremendous strides. And what we're seeing early on is evidence that the new clinicians that we're closing in the last couple of months, once they start, we see a greater cadence of re-frequent orders and that can't occur unless they're identifying patients more effectively. That to me is our, I think our number one challenge.

所以這對我來說是過去最大的障礙之一。這仍然是一個正在進行的項目。隨著時間的推移，我們將繼續磨練，但我認為我們已經取得了一些巨大的進步。我們早期看到的證據表明，我們在過去幾個月中關閉的新臨床醫生一旦開始，我們就會看到更頻繁的訂單頻率，除非他們更有效地識別患者。對我來說，這是我們的首要挑戰。

Thank you.

謝謝。

Thank you. (Operator Instructions)

謝謝。 （操作員說明）

Jens Lindqvist, Investec.

Jens Lindqvist，天達集團。

Yeah hi. I've got two or three questions, perhaps. Firstly, on the Klinrisk model, which also made some headlines during Kidney Week, and also mentioned alongside kidney inflection in the draft KDIGO guidelines. Could you provide any more color on this? Does clean risk represent a competitive threat to KidneyIntelX at all? And if not, why not?

是啊嗨。也許我有兩三個問題。首先是 Klinrisk 模型，該模型在腎臟週期間也成為了一些頭條新聞，在 KDIGO 指南草案中也提到了腎臟變形。你能提供更多的顏色嗎？清潔風險是否對 KidneyIntelX 構成競爭威脅？如果沒有，為什麼不呢？

And secondly, on the planned cost reductions, just to make sure that I understand it correctly. Could you just confirm over what period this will be achieved? Does this refer to the current financial year versus last year? Or are these the level of annualized savings that are ultimately achievable past [this onward up]? Thanks.

其次，關於計劃的成本削減，只是為了確保我理解正確。您能否確認一下這個目標需要多長時間才能實現？這是指當前財政年度與去年相比嗎？或者這些是過去[此後]最終可實現的年化儲蓄水準嗎？謝謝。

So Klinrisk, we're very familiar with Klinrisk. It is a population based risk score. So it's very different than the KidneyIntelX with it, which is an in-vitro diagnostic, and it is our firm belief that you need the biology. You need the patient's biology. That is going to drive the accuracy in early prognosis. And ultimately, that drives the characterization of the disease. The biomarkers in the blood around therapeutic response development, et cetera.

所以Klinrisk，我們非常熟悉Klinrisk。這是基於人群的風險評分。因此，它與帶有它的 KidneyIntelX 有很大不同，後者是一種體外診斷，我們堅信您需要生物學。您需要患者的生物學資訊。這將提高早期預測的準確性。最終，這決定了疾病的特徵。血液中圍繞治療反應發展的生物標記等。

So we think that KidneyIntelX as an in vitro diagnostic with biomarkers captures the patient's biology, that is totally unique. Klinrisk is a population health -- or population-developed risk score.

因此，我們認為 KidneyIntelX 作為生物標記物的體外診斷可以捕捉患者的生物學特徵，這是完全獨特的。 Klinrisk 是人口健康或人口形成的風險評分。

The other thing that's important to notice, or to note, is that we firmly believe in a holistic commercial model that's going to be required to go back to what Randy is asking, and how it is answering, why does it take so long to get adoption? Because it comes back to education at primary care. And it comes back to pushing standard of care, educating, all of that requires funding.

另一個值得注意或需要注意的重要事情是，我們堅信一個整體的商業模式，需要回到蘭迪所問的問題，以及它是如何回答的，為什麼需要這麼長時間才能被採用？因為這又回到了初級保健教育。回到推動護理和教育標準，所有這些都需要資金。

And so you need a commercial model that can generate a margin at the front end of the disease, which is what KidneyIntelX has. It has an established price. It has a CPT code. It has been regulated. So we're fully validated now, which is very important.

因此，您需要一個能夠在疾病前端產生利潤的商業模型，而這就是 KidneyIntelX 所擁有的。它有一個既定的價格。它有一個 CPT 代碼。它已受到監管。所以我們現在已經得到充分驗證，這非常重要。

And I think the challenge for a lot of the other general algorithms which are being used on large datasets is how do you get them validated? Ultimately I believe they're going to have to run through FDA, and that's going to be highly challenging. It's going to take a long time. I don't know if ultimately they can run through FDA.

我認為，對於大型資料集上使用的許多其他通用演算法來說，面臨的挑戰是如何驗證它們？最終我相信他們將必須通過 FDA 的審查，這將是極具挑戰性的。這將需要很長時間。我不知道他們最終能否通過FDA。

You're also going to have to generate a margin so that you can educate. Because it requires a sales force -- requires all sorts of activities. So you're going to have to have a reimbursement paradigm in place. So I think KidneyIntelX stands alone, because it captures the biology from an actual blood draw. It's been validated by the Food and Drug Administration, and we now have broad-based reimbursement coming in.

你也必須產生一定的利潤，以便你可以進行教育。因為它需要一支銷售團隊——需要各種各樣的活動。因此，您必須制定適當的報銷模式。所以我認為 KidneyIntelX 是獨一無二的，因為它從實際抽血中捕獲了生物學資訊。它已經得到美國食品和藥物管理局的驗證，我們現在已經有了廣泛的報銷。

So it's a very different animal than an algorithmic -- a general population algorithmic approach. Not that there isn't value, I think there's a lot of value in the algorithmic approach. But at the end of the day, you've got to have something that's regulated, reimbursed, and especially as we move into this poly-therapeutic poly-pharmaceutic application in precision medicine, where you have cocktails of therapies like the Ozempics of the world -- SGLT2 inhibitors -- you're going to have to be able to capture today's biology on that specific patient.

因此，它是一種與演算法（一般群體演算法）截然不同的動物。並不是說沒有價值，我認為演算法方法有很多價值。但歸根結底，你必須擁有一些受監管、可報銷的東西，尤其是當我們進入精準醫學中的多治療多藥物應用時，你會得到像世界上的 Ozempics 這樣的雞尾酒療法-- SGLT2 抑製劑--您必須能夠捕捉到該特定患者目前的生物學情況。

That's going to require a blood draw. And then you're in IVD land that requires regulation, et cetera. I'm going to ask Tom, if you have any additions to that? Because I know you looked at all of these things?

這需要抽血。然後你就進入了需要監管的 IVD 領域，等等。我要問湯姆，你還有什麼補充嗎？因為我知道你看過所有這些東西？

Sorry, James. Yes, we definitely have stepped back, looked at the full landscape, and with what we have at Renalytix, and the value proposition that we bring, we believe that we have identified the best path forward for having the greatest impact on clinical care, and patient outcomes, and doing it in a way that is very efficient for health systems and clinicians.

對不起，詹姆斯。是的，我們確實已經退後一步，縱觀全局，憑藉我們在 Renalytix 所擁有的以及我們帶來的價值主張，我們相信我們已經確定了對臨床護理產生最大影響的最佳前進道路，並且患者的治療效果，並以對衛生系統和臨床醫生來說非常有效的方式進行。

And I'm sorry, Jens, the second part of your question was what? We went off on --

對不起，詹斯，你問題的第二部分是什麼？我們出發了——

Yes, no, it was really on the on the timing of the planned cost reductions. Whether the cost you're referring to refer to the current financial year versus last year or these are annualized savings to be achievable over time? Thank you.

是的，不，這確實取決於計劃的成本削減的時間。您所指的成本是指當前財政年度與去年相比的成本，還是隨著時間的推移可實現的年化節省？謝謝。

I think you know, we are -- go ahead OJ.

我想你知道，我們——繼續吧，OJ。

Sure. So the reduction effort is in process already, when we talk about a 30% reduction. And we expect it to be over that in SG&A that is intended to be this quarter next year compared to today. So first quarter versus first quarter, but you'll see the evidence of that in the immediate quarters ahead, as well as we work towards it. And I think you'll see that reduction having been achieved even in the fourth quarter of this fiscal year, so like before we get to first quarter next year.

當然。因此，當我們談論減少 30% 時，減少工作已經在進行中。我們預計，與今天相比，明年本季的銷售及管理費用將超過預期的水平。所以第一季與第一季相比，但你會在接下來的幾季看到這方面的證據，我們也會為此努力。我認為即使在本財年第四季度，您也會看到減少的情況，就像我們進入明年第一季之前一樣。

Okay, thank you. Could I just have one final question, sorry to take up too much of your time. Just doing the maths on the pricing of billable tests, you get a number significantly below the $950 per test.

好的謝謝。我可以問最後一個問題嗎 抱歉佔用了您太多時間。只需計算一下計費測試的定價，您就會得到一個遠低於每次測試 950 美元的數字。

Could you perhaps elaborate a little bit on what discounts are being applied at the moment? Because my understanding was at Mount Sinai was paying full price. Thank you.

您能否詳細說明一下目前正在應用哪些折扣？因為我的理解是在西奈山支付全價。謝謝。

Yes, the short answer to that is Mount Sinai transition to the full commercial reimbursement model. In other words, we had a contract with Mount Sinai that paid $950 on testing. That contract had ended, I think, sometimes in February, and we shifted to a commercial reimbursement model, where we started billing a whole sequence of commercial payers in the New York region, and that obviously impacted -- some of these tests are moving up on reimbursement.

是的，簡短的答案是西奈山過渡到完全商業報銷模式。換句話說，我們與西奈山簽訂了一份支付 950 美元測試費用的合約。我認為，該合約有時在二月就結束了，我們轉向了商業報銷模式，我們開始向紐約地區的一系列商業付款人收取費用，這顯然受到了影響——其中一些測試正在推進關於報銷。

The pricing is $950. That's our contracted pricing. But not all the tests were paid for, which impacted the average pricing. And also there were a sequence of study tests, which I think went into the total testing volume, is that correct, OJ?

定價為 950 美元。這是我們的合約價格。但並非所有測試都是付費的，這影響了平均定價。還有一系列的研究測試，我認為這些測試已包含在總測試量中，對嗎，OJ？

Non-billable study testing.

不收費的研究測試。

Yes, that's correct.

對，那是正確的。

Okay. Thank you.

好的。謝謝。

Thank you. (Operator Instructions)

謝謝。 （操作員說明）

Thank you. And I see no further questions in the Q&A queue at this time.

謝謝。目前我在問答隊列中沒有看到更多問題。

Thank you ladies and gentlemen, this concludes today's presentation. Thank you again for your participation. You may now disconnect.

謝謝女士們、先生們，今天的演講到此結束。再次感謝您的參與。您現在可以斷開連線。