MDxHealth SA (MDXH) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon, everyone, and welcome to today's MDxHealth first-quarter 2026 earnings conference call. (Operator Instructions)

    各位下午好,歡迎參加 MDxHealth 2026 年第一季財報電話會議。(接線員指示)

  • Please note, today's call is being recorded, and it is now my pleasure to turn the meeting over to Mr. John Fraunces. Please go ahead, sir.

    請注意,今天的電話會議將被錄音。現在我很榮幸將會議交給 John Fraunces 先生。先生,請開始。

  • John Fraunces - Investor Relations

    John Fraunces - Investor Relations

  • Before we begin, I would like to remind everyone that the company will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the Risk Factors section of the company's filings with the Securities and Exchange Commission, specifically in the company's annual report on Form 20-F.

    在我們開始之前,我想提醒各位,公司將在今天的電話會議中發表前瞻性陳述。無論是在事先準備的發言或問答環節中,這些前瞻性陳述均受固有風險與不確定性影響。相關風險與不確定性已在公司向美國證券交易委員會提交之文件的「風險因素」章節中詳述,特別是在公司 Form 20-F 年度報告中。

  • I'll now turn the call over to Michael McGarrity, Chief Executive Officer.

    我現在把電話交給執行長 Michael McGarrity。

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Thanks, John, and thank you all for joining us for our first-quarter 2026 earnings conference call. With me today is Ron Kalfus, Interim Chief Financial Officer.

    謝謝你,John,也感謝各位參加我們 2026 年第一季財報電話會議。今天與我一同出席的是臨時財務長 Ron Kalfus。

  • Since I joined MDxHealth, we have been very consistent in our message and our mission. We are driven by three core operating principles: focus; execution; and growth. And while our commitment to those principles remains absolute, we also carry a great responsibility to our patients, our customers and our stakeholders to make strategic decisions that are rooted in transparency and operating discipline.

    自我加入 MDxHealth 以來,我們在訊息與使命上一直非常一致。我們由三項核心營運原則所驅動:聚焦;執行;成長。雖然我們對這些原則的承諾依然堅定不移,但我們也對病患、客戶與利害關係人肩負重大責任,必須做出以透明度與營運紀律為根基的策略決策。

  • Our Q1 results, our recent developments and the disclosures we issued today reflect a number of decisions driven by that exact responsibility. Over the past few years, our aggressive growth strategy and commercial execution have positioned MDxHealth as the leader in precision diagnostics focused specifically in urology. This strategy transformed our company from $11 million in revenue in 2019 to $108 million in 2025. We took gross margins from the 20s to the mid-60s, and we reached adjusted EBITDA profitability last year prior to our acquisition of the ExoDx business.

    我們第一季的結果、近期進展以及今天發布的揭露內容,反映了多項正是基於這份責任所做出的決策。過去幾年,我們積極的成長策略與商業執行,使 MDxHealth 成為專注於泌尿科精準診斷的領導者。此策略使公司營收從 2019 年的 1,100 萬美元成長至 2025 年的 1.08 億美元。我們將毛利率從 20% 多提升至 60% 中段,並在收購 ExoDx 業務之前,於去年達成調整後 EBITDA 獲利。

  • However, as we prioritize the ongoing integration of ExoDx and the growth of our core prostate cancer business, we have made the strategic decision to discontinue our Resolve UTI offering and to cease operations at our laboratory facility in Plano, Texas. This was a carefully considered decision. The Resolve test was uniquely designed for our urology customer base to aid in the rapid diagnosis and treatment of patients presenting with serial, complex multi-organism infections.

    然而,當我們將重點放在 ExoDx 的持續整合以及核心前列腺癌業務的成長時,我們已做出策略性決定:停止提供 Resolve UTI 產品,並終止位於德州普萊諾(Plano)的實驗室設施營運。這是一項經過審慎評估的決定。Resolve 檢測是為我們的泌尿科客戶群量身打造,用於協助快速診斷與治療那些出現連續性、複雜多菌種感染的病患。

  • Despite the urgent clinical need and the undeniable medical necessity of this test to the urologists to order it, the increasingly uncertain reimbursement landscape has made the continued operation of this business line unsustainable. Specifically, an unexplained recent policy reversal by our Texas Labs Medicare administrator, Novitas, has created a level of payer uncertainty that we are simply no longer willing to accept.

    儘管臨床需求迫切,且對泌尿科醫師而言此檢測具有無可否認的醫療必要性,日益不確定的給付(reimbursement)環境使得持續經營此業務線變得不可持續。具體而言,我們德州實驗室的 Medicare 管理機構 Novitas 近期出現一項無法解釋的政策逆轉,造成我們無法再接受的付款方不確定性。

  • In connection with this, we recently received a communication from Novitas seeking up to $10.4 million in recruitments of historical Resolve testing claims. We believe this action by Novitas is without merit, and we are vigorously defending our position through the formal Medicare appeals process. We remain fully confident in our appellate strategy and in the clinical validity of our testing services.

    與此相關,我們近期收到 Novitas 的通知,要求追討(recoupments)最高達 1,040 萬美元的歷史 Resolve 檢測理賠。我們認為 Novitas 的此項行動毫無根據,並正透過正式的 Medicare 申訴程序積極捍衛我們的立場。我們對申訴策略以及檢測服務的臨床有效性仍然充滿信心。

  • While stepping away from Resolve is unfortunate for the thousands of patients who have benefited from the test, we view this proactive exit as a powerful catalyst for our company. First and foremost, it allows us to focus our capital and operational excellence entirely on our prostate cancer precision diagnostics, where we drive the most scalable value. By stepping away from the reimbursement volatility of Resolve, our entire sales organization is now able to focus 100% on our core prostate cancer menu, Confirm, GPS and ExoDx. It is important to highlight that we have already completed the Exo-driven strategic mapping and cross-training of our expanded sales force in Q1.

    雖然退出 Resolve 對於已受惠於該檢測的數千名病患而言令人遺憾,但我們將這項主動退出視為公司強而有力的催化劑。首先也是最重要的,它使我們能將資本與營運卓越能力完全聚焦於前列腺癌精準診斷,這是我們能創造最具規模化價值的領域。透過遠離 Resolve 的給付波動,我們整個銷售組織如今能 100% 專注於核心前列腺癌產品組合:Confirm、GPS 與 ExoDx。值得強調的是,我們已在第一季完成以 Exo 為驅動的策略版圖規劃,以及擴編銷售團隊的交叉訓練。

  • Furthermore, we successfully met our internal goal of transitioning our SelectMDx customers to Exo, resulting in accelerating operating efficiencies as we no longer process select samples. With our sales force fully armed and aligned, we are cementing our position as the growth vertical in urology, offering an unmatched suite of precision diagnostics, addressing every single point in the prostate cancer pathway.

    此外,我們成功達成內部目標,將 SelectMDx 客戶轉換至 Exo,並因此加速營運效率提升,因為我們不再處理 Select 樣本。隨著銷售團隊已充分武裝並一致對齊,我們正鞏固在泌尿科領域的成長定位,提供無可匹敵的精準診斷套組,涵蓋前列腺癌照護路徑中的每一個環節。

  • An additional value driver of this refocus is our ability to catalyze our commitment to leveraging artificial intelligence. Earlier this year, we initiated an AI-dedicated strategic initiative to build out an AI data platform across the company. With the hundreds of thousands of unique biopsy tissue specimens we receive, our goal is to leverage AI to advance operating efficiency, maximize clinical value and optimize our customer experience. In fact, we are seeing evidence of this with our landmark PROTECT trial in collaboration with the University of Oxford, where the study protocol now includes AI-enhanced endpoints targeted to improve the prognostic value of our GPS test.

    這次重新聚焦的另一項價值驅動因素,是我們得以加速落實運用人工智慧的承諾。今年稍早,我們啟動一項專注於 AI 的策略計畫,以在全公司建置 AI 資料平台。憑藉我們收到的數十萬份獨特切片活檢組織檢體,我們的目標是運用 AI 提升營運效率、最大化臨床價值並優化客戶體驗。事實上,我們已在與牛津大學合作的里程碑式 PROTECT 試驗中看到相關證據,該研究方案現已納入 AI 強化的終點指標,旨在提升我們 GPS 檢測的預後價值。

  • Furthermore, we have initiated a collaboration with a customer-facing digital innovation company to develop AI-enhanced offerings that build on the evidence-based excellence of our tissue tests. We are incredibly proud of our team's commitment to not only the financials, but to what really matters, the patient and family on the other side of every sample we receive.

    此外,我們已與一家面向客戶的數位創新公司展開合作,開發以 AI 強化的產品與服務,並建立在我們組織檢測以實證為基礎的卓越表現之上。我們為團隊的投入感到無比自豪,因為我們不僅關注財務表現,更關注真正重要的事——在我們收到的每一份檢體背後的病患與家庭。

  • I will follow up with some closing comments and our updated view forward. But first, let me turn the call over to Ron to walk through our first quarter financial results. Ron?

    我稍後會補充一些結語以及我們更新後的前瞻觀點。但首先,讓我把電話交給 Ron,請他帶大家回顧第一季財務結果。Ron?

  • Ron Kalfus - Interim Chief Financial Officer

    Ron Kalfus - Interim Chief Financial Officer

  • Thank you, Mike. Before I dive into the financial results, I want to briefly frame our Q1 presentation. Because our Board's strategic decision to exit the Resolve mdx business occurred in April, the financial results of the Plano Laboratory and Resolve business remain embedded within our as reported continuing operations for the first quarter. However, to provide investors with a clear and transparent view of our core business trajectory moving forward, we have provided pro forma as adjusted tables in our earnings release. These tables entirely back out the revenue and direct operating expenses of the Resolve business.

    謝謝你,Mike。在我深入說明財務結果之前,我想先簡要說明我們第一季簡報的呈現方式。由於董事會在 4 月做出退出 Resolve mdx 業務的策略決策,普萊諾實驗室與 Resolve 業務的財務結果在第一季仍包含於我們按申報口徑(as reported)的持續營運之中。然而,為了讓投資人能清楚且透明地了解我們核心業務未來的發展軌跡,我們在財報新聞稿中提供了經調整的備考(pro forma as adjusted)表格。這些表格已完全剔除 Resolve 業務的營收與直接營運費用。

  • To help you model the ongoing business, I will provide the statutory results today and compare them directly to these pro forma metrics of our continuing prostate cancer operations. Our as reported revenue for the first quarter ended March 31, 2026, was $27.4 million. However, on a pro forma basis, excluding the Resolve business entirely, revenues for our core prostate cancer operations increased by 11% to $23.9 million, demonstrating the continued commercial execution of our integrated sales team.

    為協助各位建立對持續營運業務的模型,我今天將提供法定(statutory)申報結果,並直接與我們持續的前列腺癌營運之備考指標進行比較。我們截至 2026 年 3 月 31 日止第一季按申報口徑的營收為 2,740 萬美元。然而,以備考口徑、完全排除 Resolve 業務後,我們核心前列腺癌營運的營收成長 11% 至 2,390 萬美元,顯示整合後銷售團隊持續的商業執行力。

  • Moving below the revenue line, our statutory as reported gross profit was $16.6 million. When we back out the Resolve business, our pro forma gross profit for the quarter was $15 million, yielding a pro forma gross margin of 62.9% compared to 68% for Q1 2025, with the difference primarily related to tissue versus liquid mix. Our as reported operating expenses for the quarter were $23.9 million, resulting in an as reported operating loss of $7.3 million. On a pro forma basis, excluding the direct operating expenses of Resolve, our pro forma operating expenses were $22.9 million, resulting in a pro forma operating loss of $7.9 million compared to a pro forma operating loss of $4.7 million for the prior year, primarily related to the addition of the ExoDx business.

    在營收之下,我們法定按申報口徑的毛利為 1,660 萬美元。剔除 Resolve 業務後,本季備考毛利為 1,500 萬美元,備考毛利率為 62.9%,相較於 2025 年第一季的 68%,差異主要與組織檢體(tissue)與液體檢體(liquid)的組合變化有關。我們本季按申報口徑的營業費用為 2,390 萬美元,導致按申報口徑的營業損失為 730 萬美元。以備考口徑、排除 Resolve 的直接營運費用後,備考營業費用為 2,290 萬美元,備考營業損失為 790 萬美元;相較去年同期備考營業損失 470 萬美元,主要原因是新增 ExoDx 業務。

  • Our statutory as reported net loss was $8.9 million. Excluding Resolve, our pro forma net loss was $9.4 million compared to a pro forma net loss of $9.3 million for Q1 of last year. Once again, I'd like to direct investors to the tables at the back of today's press release where we have provided a detailed columnary reconciliation of our statutory IFRS results for the pro forma adjustments.

    我們法定按申報口徑的淨損為 890 萬美元。排除 Resolve 後,我們的備考淨損為 940 萬美元,相較於去年第一季備考淨損 930 萬美元。再次提醒投資人參閱今天新聞稿末尾的表格,我們在其中提供了法定 IFRS 結果與備考調整之間的詳細逐欄(columnary)調節表。

  • Finally, our balance sheet remained solid for the quarter with cash and cash equivalents as of March 31, 2026, totaling $43.2 million. In addition, on April 15, we made the 2025 earn-out payment to Exact Sciences in the amount of $15 million. After taking into account this earn-out payment, our pro forma cash as of March 31, 2026, would have been $28.2 million.

    最後,本季資產負債表仍維持穩健,截至 2026 年 3 月 31 日的現金及約當現金合計為 4,320 萬美元。此外,我們於 4 月 15 日向 Exact Sciences 支付 2025 年的或有對價(earn-out)款項 1,500 萬美元。若將該筆 earn-out 付款納入考量,我們截至 2026 年 3 月 31 日的備考現金將為 2,820 萬美元。

  • This concludes my overview of the financial results, and I will now turn the call back to Mike.

    以上為我對財務結果的概述,現在我把電話交回給 Mike。

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Thanks, Ron. As we look forward, we believe that the near-term impact of our strategic exit from Resolve will ultimately augment our ability to drive sustainable, highly profitable growth across our core prostate cancer menu. By streamlining our operations and removing the reimbursement noise associated with the UTI business, we are effectively resetting our growth trajectory. Today, we are establishing updated 2026 revenue guidance for our core cancer business, excluding Resolve, of $110 million to $115 million. This represents a robust 20% to 26% year-over-year growth rate for our core cancer business.

    謝謝你,Ron。展望未來,我們相信,短期內退出 Resolve 的策略性影響,最終將提升我們在核心前列腺癌產品組合上推動可持續且高獲利成長的能力。透過精簡營運並移除與 UTI 業務相關的給付雜訊,我們正有效地重設成長軌跡。今天,我們建立更新後的 2026 年核心癌症業務(不含 Resolve)營收指引為 1.10 億至 1.15 億美元。這代表核心癌症業務年增率達 20% 至 26%,成長動能強勁。

  • Our culture of quality first and customer always will ensure our growing reputation for excellence in the urology market. We will continue to strive to deliver on our commitments of growth and value, positioning MDxHealth as the leading precision diagnostics company focused solely on the high-growth urology space. As always, we carry a great deal of responsibility to provide value to all of our stakeholders, including our patients, our clinicians, our payers and our shareholders. Thank you for your continued interest in and support of MDxHealth.

    我們以品質優先、客戶至上的企業文化,將確保我們在泌尿科市場中日益成長的卓越聲譽。我們將持續努力兌現成長與價值的承諾,將 MDxHealth 定位為專注於高成長泌尿科領域、領先的精準診斷公司。一如既往,我們肩負重大責任,必須為所有利害關係人創造價值,包括病患、臨床醫師、付款方以及股東。感謝您持續關注並支持 MDxHealth。

  • Now I'll turn the call back to the operator for questions.

    現在我把電話交回給接線員進行提問。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Dan Brennan, TD Cowen.

    Dan Brennan,TD Cowen。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Hey, guys. Thanks for the questions. Maybe just starting on the Novitas issue. I guess you guys cited $10.4 million related to retrospective review of certain historical Resolve mdx claims. And I know you're going to vigorously defend it. But can you -- any other color you can provide on what the issue is there? And given the cash balance, like how do we think about the $10.4 million and just the cushion you guys think you have on that? And anything on timing, how this will play out?

    嗨,各位。謝謝讓我提問。先從 Novitas 的議題開始。你們提到有 1,040 萬美元與對部分歷史 Resolve mdx 理賠申請進行追溯性審查有關。我知道你們會積極捍衛。但你們能否再補充一些背景,說明那邊的問題到底是什麼?另外,考量現金餘額,我們該如何看待這 1,040 萬美元,以及你們認為在這方面有多少緩衝?還有時程上,這件事會如何發展?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Yeah, Dan, we anticipate this will not be resolved or adjudicated for a significant period of time, unless it's immediately in our favor. And we feel like that's a high likelihood. We -- This is a very recent development that we're communicating. So we have no sense of our multiple initial replies. So it's difficult to bracket the time line, but likely well beyond the period of time that we're focused on here between now and the end of the year.

    是的,Dan,我們預期這件事在相當長一段時間內不會解決或裁決,除非結果立即對我們有利。而我們認為這種情況的可能性很高。我們——這是我們正在對外溝通的一項非常近期的進展。因此,對於我們多次初步回覆的結果,我們目前沒有任何掌握。很難界定時間軸,但很可能遠遠超過我們目前關注的期間,也就是從現在到年底之間。

  • And I would say that although we don't anticipate any liability or recoupment, if there were any minimal, it would be amortized over a five-year period. But I only share that based on our understanding. We don't anticipate -- we'd anticipate a quick positive resolution or a longer-term adjudication in our favor.

    我也想說,雖然我們不預期會有任何責任或追討,但即便真的有任何極小的金額,也會在五年期間內攤銷。不過我分享這點只是基於我們的理解。我們不預期——我們預期要嘛很快得到正面解決,要嘛進入較長期、但最終對我們有利的裁決程序。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Got it. And Mike, is there any -- just maybe one more quick one there. Is there any issues or any feedback you've had throughout the process of billing there where they were calling in the question, clinical utility of the test? Or is there any issues on that front? Or just anything else you can share on that?

    了解。Mike,再追問一個很快的問題。就那邊的計費流程而言,你們是否曾收到任何質疑或回饋,例如他們在質疑檢測的臨床效用?或在這方面有任何問題?還是你能再分享其他資訊?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • We don't -- as you can imagine, we don't have any further comment on our -- any communication back and forth other than to present full transparency and everything we know as of today. We -- I will say we have absolute certainty and would find impossible to argue the medical necessity and clinical validity of our test for the patients that are treated.

    我們不——如你所想像,我們除了以完全透明的方式呈現截至今日我們所知的一切之外,對於來回溝通內容沒有進一步評論。我會說,我們對於我們檢測在受治療病患上的醫療必要性與臨床有效性具有絕對確信,且幾乎不可能有人能提出相反的論點。

  • It's important to note that a lot of this focus on broadened abuse with infectious disease testing, which UTI has been noted in what is not policy-based, but communications coming out of Novitas. It is not the type of test that we are offering to the customer base we are, right? We market our test specifically to urology customers for a very specific patient population.

    需要強調的是,許多焦點其實是放在傳染病檢測的擴大濫用上,而 UTI 在 Novitas 對外發布的溝通中被提及——這些並非政策文件,而是其對外訊息。這並不是我們提供給客戶群的那種檢測,對吧?我們的檢測是專門行銷給泌尿科客戶,針對非常特定的病患族群。

  • And it is patients that are referred to urology, right? When you have a UTI, you don't call urologists. This is not your run-of-the-mill, immediate care, get put on cipro and you're brand new. These are patients that present in men with the large prostate or BPH, are prone to these. Women are referred to urology for these.

    而且這些是被轉診到泌尿科的病患,對吧?當你有 UTI 時,你不會去找泌尿科醫師。這不是那種一般常見、立即就醫、開個 Cipro(環丙沙星)就結束、而且你是新發病的情況。這些病患多見於男性前列腺肥大或 BPH,較容易反覆發作;女性也會因此被轉診到泌尿科。

  • We've had patients and clinicians present at our national sales meeting and the clinical value is impossible to argue and remarkably compelling. So the broad panel of organisms and susceptibility markers, in addition, a little bit more detail. Our test is in the 20s of organisms and susceptibility markers. Each run is a specific reaction for each analyte or target organism. So we have exhausted when we entered the market, are following the AMN guidelines. I'll leave it there, but it leads to our confidence and for sure, the medical necessity and our ultimate process.

    我們在全國銷售會議上邀請病患與臨床醫師分享,而其臨床價值幾乎無可辯駁,且非常有說服力。再補充一些細節:我們的檢測涵蓋二十多種微生物與藥物敏感性標記。每一次檢測執行時,針對每個分析物或目標微生物都會進行特定反應。因此,我們在進入市場時已做了充分驗證,並遵循 AMN 指引。我就先說到這裡,但這些都支撐了我們的信心——醫療必要性以及我們最終流程的正當性。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Got it. Thanks for that, Mike. And maybe for the follow-up, just on the core, maybe versus your guys' expectations, obviously, really strong growth in liquid. Tissue was up against a really tough comp there. Just tell me how did the quarter play out versus your expectations? And as you kind of have the updated guide, like kind of what are you incorporating? Or like how are you thinking about the rest of the year across your two businesses? Thank you.

    了解。謝謝你,Mike。再追問一下,回到核心業務,和你們原本的預期相比,液體檢測成長非常強勁。組織檢測則面臨非常艱難的比較基期。請談談本季實際表現相較你們預期如何?以及在更新指引後,你們納入了哪些假設?或你們如何看待今年剩餘時間兩個業務的走勢?謝謝。

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Thanks, Dan. Yeah, I think we would appreciate your comments because it's what we expected and I communicated as far as Q4 and Q1 with the integration. There will be some focus on the transition of our Resolve customers. It's important to note also that every one of our Resolve customers is urology customers. So our reps will be navigating that with our customers.

    謝謝,Dan。是的,我們也感謝你的評論,因為這正是我們所預期的,也如我先前就整合在 Q4 與 Q1 所溝通的:會有一些重點放在 Resolve 客戶的轉換上。也要注意,我們所有 Resolve 客戶都是泌尿科客戶。因此,我們的業務代表會與客戶一起推進這項轉換。

  • We're confident that we'll navigate through that. And then our guidance adjustment really reflects, while we don't break it out and haven't broken it out historically, made the assumption that it's really stripping out our expectation of what Resolve will contribute. That's essentially the calculus of our new guide.

    我們有信心能順利度過。至於我們調整指引,實際上反映的是——雖然我們沒有拆分揭露、過去也未曾拆分——我們假設等同於把我們對 Resolve 貢獻的預期剔除。這基本上就是我們新指引的計算方式。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • And any color just on the strength in liquid? Obviously, tissue up against a really tough comp, but on a comp adjusted basis, nice growth. Just anything to point out across the two segments as we look out for the rest of the year?

    那對於液體檢測的強勁表現,有沒有更多補充?顯然組織檢測面臨很艱難的比較基期,但若以調整後的比較基期來看也有不錯的成長。就兩個部門而言,對於今年剩餘時間,有沒有什麼值得指出的重點?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • No, I think there might be some embedded strength there because we were -- there was some additional adjustment to our Q1 revenue based on the fact that we're conservatively non accruing going forward here, cash only. So I don't have any additional comment other than our guidance clearly reflects confidence in our core cancer business, both tissue and Exo.

    沒有。我認為其中可能有一些內含的強勁因素,因為我們——我們對 Q1 營收做了額外調整,原因是我們在此之後採取保守作法,不再計提應計收入,改為僅收現金。因此,除了我們的指引清楚反映我們對核心癌症業務(包含組織與 Exo)的信心之外,我沒有其他補充。

  • And we -- I'll just add that at the risk of being covered here, we view this -- we believe we'll look back on this as a blessing in disguise from a focus benefit of our sales organization because one rep selling four tests, Resolve is a great test that has been broadly adopted, but it requires focus and time with our customers and obviously, our organizational support of that.

    另外我再補充一點,雖然可能已經被涵蓋:我們認為——我們相信回頭看,這會是因禍得福,因為它能讓我們的銷售組織更聚焦。一位業務代表要銷售四項檢測;Resolve 是一個很好的檢測,也已被廣泛採用,但它需要與客戶投入更多專注與時間,當然也需要我們組織層面的支援。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Okay, great. Thanks.

    好的,很棒。謝謝。

  • Operator

    Operator

  • We go next now to Bill Bonello with Craig-Hallum.

    接下來是 Craig-Hallum 的 Bill Bonello。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Hey, guys. Thanks for taking the question. I want to focus a little bit on the cash situation here. So when you think about the restructuring expenses that you're going to incur, do you have any sense of the magnitude of the cash outlay that may go along with that?

    嗨,各位。謝謝讓我提問。我想稍微聚焦在現金狀況。當你們考量將要發生的重整費用時,你們是否能估計相關的現金支出規模大概會是多少?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Yeah, Bill. I think we're confident that our expectation would be the operation would cease by the end of June. Obviously, the majority of the Plano operation is carried in COGS. But we expect to derive any additional expense associated with that will be absorbed by additional efficiencies across our operation that has adjacent or, I guess, blended support of our Resolve business in our operation across RCM client services and shared services with operation and product support. So I guess that -- hopefully, that answers your question, if I understood your question.

    是的,Bill。我們有信心,我們的預期是該營運會在六月底前停止。當然,Plano 營運的大部分成本是列在銷貨成本(COGS)中。但我們預期,任何與此相關的額外費用,都會透過我們營運中的其他效率提升來吸收;這些效率提升來自於在 RCM 客戶服務與共享服務中,對 Resolve 業務提供相鄰或我想說是混合式支援的營運、以及產品支援。希望我理解你的問題並回答到了。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • I mean -- somewhat, I mean, it just -- you got -- I just want to make sure I understand that. I mean there's going to be some severance payments you're going to be making. There's charges on the lease that you mentioned, et cetera. Those are all cash. And so you're thinking you can offset that cash outlay that may come over the next couple of quarters, you can completely offset that with enhancements to the rest of the business?

    我的意思是——算是有回答,但我只是——我想確認我理解正確。你們會有一些資遣費要支付,還有你們提到的租約相關費用等等。這些都是現金支出。所以你們的想法是,未來幾季可能發生的這些現金支出,可以透過其他業務的改善來完全抵銷嗎?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • We're confident that there'll be a considerable offset there, Bill.

    我們有信心會有相當程度的抵銷,Bill。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Okay. And then when you think about --

    好的。然後當你考量——

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • The only term I used differently, we said completely, I mean, whether it's complete, materially offset. Just for transparency, Bill.

    我唯一用詞不同的是,你說「完全」。我的意思是,不論是否「完全」,至少會在重大程度上抵銷。為了透明起見,Bill。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Yes. Okay. And then just when I look at the pro formas, and I think there's maybe $700,000-something of expense that you put with Resolve. Can you give us some sense of what those expenses are? Just -- and what I'm trying to get at here is how easy will it actually be to eliminate operating expense? What's truly attached to Resolve and what was just covering fixed costs?

    是。好的。然後我看你們的備考(pro forma)資料,我想你們把大約 70 萬美元左右的費用歸在 Resolve。你們能否說明一下那些費用是什麼?我想了解的是,實際上要消除營運費用(OpEx)有多容易?哪些是真正與 Resolve 綁定的,哪些只是用來分攤固定成本?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Mainly incentive comp, Bill, to our sales organization for the Resolve test, if I'm understanding that question correctly. And again, as we -- we're not in a position right now to fully reconcile, but to your two-part question, we expect the majority of the offset of the closing of the operation, the associated costs with that to be offset by efficiencies across the organization. And then from an OpEx perspective, while I noted that the majority of OpEx -- the OpEx will not change materially because the majority of the Plano carry was in COGS. We would expect some benefit, IC is a good example, right, to our (multiple speakers)

    主要是我們銷售組織針對 Resolve 檢測的獎勵性薪酬(incentive comp),Bill,如果我正確理解你的問題。再者,就你問題的兩個部分而言,我們目前還無法完全對帳,但我們預期,關閉該營運及其相關成本的大部分,將可透過全公司範圍的效率提升來抵銷。至於營運費用(OpEx),如我提到的,OpEx 不會有重大變動,因為 Plano 的大部分成本是在銷貨成本(COGS)中。我們預期會有一些效益,IC 就是一個很好的例子,對吧,對我們的(多位發言者)

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Okay. That's really helpful. And then just -- I guess, if I can, and I'll get out of the way and let other people ask questions. But just on the tissue volume, just trying to get a better understanding of what's going on there? It's been sort of moving steadily downward.

    好的。這真的很有幫助。然後就是——我想,如果可以的話,我問完就不佔用時間,讓其他人提問。不過就組織(tissue)檢測量而言,我只是想更清楚了解那邊到底發生了什麼?它似乎一直在穩步下滑。

  • And I know you've been doing a big integration and Salesforce was distracted by that. But it's sort of hard to believe at these trends that there's nothing else at all happening. So I guess I'm just trying to get what can you tell us about whether you've actually been losing some customers on the GPS side or maybe people are not continuing to use Confirm, or what -- why are we seeing volume actually going down?

    我知道你們一直在做大型整合,而 Salesforce 也因此分心。但照這樣的趨勢,很難相信完全沒有其他事情在發生。所以我想釐清的是:你們能否告訴我們,在 GPS 端是否其實流失了一些客戶,或是有人沒有繼續使用 Confirm,或是——為什麼我們看到檢測量實際在下降?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Yeah. So I think -- I understand the question. I think I would say there's a multifactorial impact there, right? We have made significant progress, as I've noted and based on our trending consistent growth profile is sticky adoption. There are aspects of our tissue-based tests that are -- require focus and continued work with our customer base with both Confirm and GPS.

    是的。所以我想——我理解這個問題。我會說那裡有多重因素的影響,對吧?如我所提到的,基於我們的趨勢,我們在一致的成長輪廓上已取得顯著進展,這反映出黏著式採用(sticky adoption)。我們的組織型檢測在 Confirm 與 GPS 兩個產品上,仍有一些面向需要聚焦,並持續與客戶群合作推進。

  • You commented on the integration, which I fully anticipated, and we expect clearly reflected in our guidance to see a sequential acceleration on the tissue side, even with the focus required on this new development that was related to Resolve on the tissue side in Q3 -- I'm sorry, Q2, Q3 and Q4 as we go forward. And that's part of the calculus that we understand with our mapping of our customer base, our utilization rates, our -- the implied churn or whatever that we would have.

    你提到整合,我完全預期會如此,而且我們也在財測指引中清楚反映:即便在組織端需要投入心力處理與 Resolve 相關的新進展——發生在第三季——抱歉,是第二季、第三季與第四季,隨著我們往前推進——我們仍預期組織端會出現逐季加速。這也是我們在盤點客戶基礎、使用率、以及隱含流失(churn)或其他可能情況時所納入的計算之一。

  • And we've made so much progress on that over the last couple of years that we're confident that fixed. And as we look at the comp quarter that Dan noted, we would attribute it to those multiple factors. And our guidance requires that, that comes back online on the tissue side as we anticipated at the beginning of the year, knowing that Q1 would be choppy.

    而且過去幾年我們在這方面已經取得很大進展,因此我們有信心這些問題已被修正。就 Dan 提到的可比季度來看,我們會把它歸因於上述多重因素。而我們的指引也要求:如同年初所預期的那樣,組織端會回到正軌,因為我們知道第一季會比較顛簸。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Sure. Okay, thank you.

    好的。明白了,謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Mark Massaro, BTIG.

    Mark Massaro,BTIG。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Hey, guys. Thank you for taking the question. I apologize. I hopped on the call a few minutes late. So I wanted to just ask a clarifying question. I saw from your press release that you received a Medicare recruitment decision from Novitas. But I wanted to ask, did you receive a non-coverage determination? So I'm just -- the clarification is, is the coverage suspended at this time?

    嗨,各位。謝謝讓我提問。不好意思,我晚了幾分鐘才加入電話會議。所以我想問一個釐清問題。我從你們的新聞稿看到,你們收到了 Novitas 的 Medicare 招募(recruitment)決定。但我想問的是:你們是否收到了不予給付(non-coverage)的裁定?所以我想釐清的是:目前給付是否已被暫停?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Mark, my answer to that is we've not -- I don't know that Novitas has a coverage policy, which you're very experienced in this segment. I mean I don't -- I think I commented MolDX or California MAC has a clear policy related to UTI testing. Novitas does not. There have been communications that have come out over time, probably over the last year or two where they're calling attention to it and focused on fraud and abuse. I think this is government down to -- and I think that MolDX has probably held up as -- while difficult to navigate through MolDX, we've experienced that, that they have a standard and a policy coverage.

    Mark,我的回答是:我們沒有——我不確定 Novitas 是否有給付政策,而你在這個領域非常有經驗。我的意思是,我不——我想我提過 MolDX 或加州的 MAC 對 UTI 檢測有明確政策;Novitas 沒有。過去一段時間——可能過去一兩年——他們有發布一些溝通內容,提醒並聚焦在詐欺與濫用。我認為這是政府層級一路往下——而且我認為 MolDX 可能被視為——雖然 MolDX 很難應對,我們也有這樣的經驗——但他們至少有一套標準與給付政策。

  • We have followed the AMA guidelines and the guidelines associated with how we have built Novitas and Medicare for the past five years, Mark. And we know -- I think you would probably know this, too, from a landscape perspective. We know we're not alone here. In fact, I would add an additional point here that we have urology customers that have brought UTI testing in-house through whatever methodology they're using our platform. And they are coming to us saying that they are experiencing reimbursement and are looking to bring reimbursement challenges, inconsistencies.

    Mark,過去五年我們一直遵循 AMA 指引,以及我們建立 Novitas 與 Medicare 作業方式所依循的相關指引。我們也知道——我想你從產業版圖角度也會知道——我們並不是唯一遇到這種情況的。事實上,我還要補充一點:我們有泌尿科客戶已透過他們採用的各種方法,使用我們的平台把 UTI 檢測內部化(in-house)。他們回頭跟我們說,他們也遇到給付問題,並希望處理給付上的挑戰與不一致。

  • But we don't have a policy to lean on to explain their behavior. And we are very confident to my opening comment, which you missed, we can follow up that medical necessity is unquestioned and a very ambiguous seemingly change in their posture on paying tests they paid for over time.

    但我們沒有一個可以依循的政策來解釋他們的行為。而且我對我開場時的評論非常有信心——你剛剛錯過了,我們可以再跟進——醫療必要性(medical necessity)是無庸置疑的,而他們對於支付那些過去一直有支付的檢測,似乎出現了非常模糊的立場變化。

  • We are not willing to try different billing schemes. We're just making what we believe is the prudent near and long-term decision for our company and for all of our stakeholders to maintain our transparency and integrity. It's unfortunate. It's remarkably unfortunate because of the value to patients and the way we've responsibly marketed this test.

    我們不願意嘗試不同的申報(billing)方案。我們只是做出我們認為對公司以及所有利害關係人而言,在短期與長期都審慎的決策,以維持透明度與誠信。這很不幸,真的非常不幸,因為這項檢測對病患的價值,以及我們一直以負責任的方式行銷這項檢測。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Okay. Has -- so -- it -- I understand why you made the decision to cease operations in Texas. But did you guys evaluate the option to run the test out of a separate lab in a Medicare jurisdiction that does have coverage?

    好的。那——我理解你們為什麼決定停止德州的營運。但你們是否評估過另一個選項:把檢測改由另一個位於有給付的 Medicare 管轄區的實驗室來執行?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Yeah, Mark, I don't think I'd comment any more on all of the complex decision-making process that we went through. So I don't really have a comment. I mean our Irvine laboratories and MolDX, which has a noncoverage decision for UTI test.

    是的,Mark,我想我不會再多評論我們所經歷的所有複雜決策過程。所以我沒有更多評論。我的意思是,我們的 Irvine 實驗室以及 MolDX——MolDX 對 UTI 檢測有不予給付(noncoverage)的決定。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Yeah. All right. And then last one for me. Are you seeing any -- as a follow-up to Bill's question on the tissue volume side, are you seeing any changes in the competitive landscape that you can speak of?

    好的。那我最後一個問題。作為對 Bill 關於組織檢測量問題的追問,你們是否看到競爭格局有任何變化可以分享?

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Nothing material from the two competitors on the GPS side.

    在 GPS 端的兩個競爭對手方面,沒有任何重大的變化。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Okay. Thank you for the time.

    好的。謝謝你們撥冗。

  • Operator

    Operator

  • Dan Brennan, TD Cowen.

    Dan Brennan,TD Cowen。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Hey, guys. Maybe just one more since -- probably follow up later. Just -- Michael, to your point on the tissue volume acceleration, can you just elaborate a little bit in terms of some of the initiatives and efforts that you kind of discussed in terms of seeing that sequential acceleration? Any color, qualitative color you can provide just about the visibility, confidence in that acceleration? Thanks.

    嗨,各位。也許再問一個,之後可能還會再追問。Michael,針對你提到的組織檢測量加速,你能否再多談一點你們提到的一些計畫與努力,如何帶來逐季加速?你能否提供一些補充、定性上的說明,談談你們對這個加速的能見度與信心?謝謝。

  • Michael McGarrity - Chief Executive Officer, Director

    Michael McGarrity - Chief Executive Officer, Director

  • Yeah. I mean I think maybe to provide to Mark's last question, the one competitive landscape change I should have noted, Mark, is on the AI side. And I think there's a lot of discussion, I don't want to say noise, but awareness of and communication about the promise of AI in our space, particularly relevant to GPS. And what I noted in our strategy here going forward, including the partnership that we've entered into is that we've been very patient in -- and rigorous in our process as to the best path forward. We have not been the steep of the wheel, but we've also not panicked.

    好的。我想也許回到 Mark 最後那個問題,我應該補充的一個競爭格局變化是 AI 端。我認為有很多討論——我不想說是雜音——但確實有更多對於 AI 在我們領域承諾的認知與溝通,尤其與 GPS 相關。正如我在我們接下來的策略中所提到的,包括我們已簽訂的合作夥伴關係,我們在選擇最佳前進路徑的流程上一直非常有耐心——也非常嚴謹。我們沒有急著搶當領頭羊,但我們也沒有恐慌。

  • I think we've gone through a prudent exercise of our operational value and use of AI, which does drive, as I noted, all of our clinical data generation and study protocols. But more importantly, the partnership that we've entered into, when I know customer-facing, my comment would be there is that this partner provides relevant urology, pathology services to our common customer base.

    我認為我們已經就 AI 的營運價值與使用,做了一個審慎的評估;如我所說,AI 確實驅動我們所有臨床數據生成與研究方案。但更重要的是,我們所建立的合作夥伴關係——就我所知、從客戶端角度來看——這個合作夥伴為我們共同的客戶群提供相關的泌尿科與病理服務。

  • So we are very, very confident that our patient approach there -- there's not a company in the space that has been partnered with or available with AI technology that we haven't spoken to or evaluated, and we're very confident that the efforts we're taking internally and the partnership that we have embarked on will drive significant support for our GPS and Confirm business. But that coupled with our execution focus of the sales organization, I guess those are the couple, two or three different bases that we have for being confident that tissue begins to accelerate as we go forward.

    因此,我們對我們在那裡採取的「耐心」做法非常、非常有信心——在這個領域裡,凡是有 AI 技術、可合作或可取得的公司,我們沒有一家沒談過或沒評估過。我們非常有信心,我們內部所做的努力以及我們已啟動的合作夥伴關係,將為我們的 GPS 與 Confirm 業務帶來顯著支持。再加上我們對銷售組織的執行力聚焦,我想這就是我們對組織端在未來開始加速的信心來源,約莫兩到三個面向。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Okay, thank you.

    好的,謝謝。

  • Operator

    Operator

  • And gentlemen, it appears we have no further questions today. So ladies and gentlemen, that will bring us to the conclusion of today's MDxHealth first-quarter 2026 earnings conference call. We'd like to thank you all so much for joining us today and wish you all a great rest of your day. Goodbye.

    各位先生,看起來今天沒有進一步的問題了。因此,各位女士先生,這也將帶我們結束 MDxHealth 2026 年第一季財報電話會議。非常感謝各位今天的參與,也祝各位今天剩下的時間一切順利。再見。