Personalis Inc (PSNL) 2025 Q3 法說會逐字稿

Good afternoon and Welcome to Personalis' 3rd Quarter 2025 earnings call.

下午好，歡迎參加 Personalis 2025 年第三季財報電話會議。

[Operator instruction]

[操作說明]

I'll now hand you over to Caroline Corner of Investor Relations. Please go ahead.

現在我將把發言權交給投資人關係部門的卡洛琳‧科納。請繼續。

Thank you, operator. Welcome to Personali's 3rd Quarter 2025 earnings call. Joining today's call are Christopher Hall, Chief Executive Officer and President, Aaron Tachibana, Chief Financial Officer and Chief Operating Officer, and Richard Chen, Chief Medical Officer and EVP R&D.

謝謝接線生。歡迎參加 Personali 2025 年第三季財報電話會議。今天參加電話會議的有執行長兼總裁克里斯多福·霍爾、財務長兼營運長亞倫·塔奇巴納以及首席醫療官兼研發執行副總裁理查德·陳。

All statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements within the meaning of the US securities laws. For example, any statements regarding trends and expectations for our financial performance this year and longer-term, cash runway and liquidity position, revenue expectations and timing. Size and booking of orders, products, services, technology, expansion of clinical volume, reimbursement goals, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, market size, and market opportunity and business outlook.

本次電話會議中所有與歷史事實無關的陳述均應被視為美國證券法意義上的前瞻性陳述。例如，任何關於我們今年及長期財務表現趨勢和預期、現金儲備和流動性狀況、收入預期和時間安排的聲明。訂單規模和預訂情況、產品、服務、技術、臨床業務量的成長、報銷目標、報銷決策的結果和時間、對現有和未來合作活動的預期、成本預期、市場規模、市場機會和業務前景。

These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our recent filings, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements, except as required by applicable law.

這些聲明存在風險和不確定性，可能導致實際結果與我們目前的預期有重大差異。我們建議您查閱我們最近提交的文件，包括我們在最新文件中所述的風險因素。除適用法律另有規定外，Personalis 不承擔更新這些聲明的義務。

Our press release with our third quarter of 2025 results is available on our website www.personalis.com... under the investors section and includes additional details about our financial results. Our website also .has the latest SEC filings which we encourage you to review.

我們已在網站 www.personalis.com... 的投資者關係欄位中發布了 2025 年第三季業績新聞稿，其中包含有關我們財務業績的更多詳細資訊。我們的網站上還有最新的美國證券交易委員會（SEC）文件，我們鼓勵您查閱。

A recording of today's call will be available on our website by 5:00 p.m. Pacific Time today. With that, I would like to turn the call over to Chris.

今天電話會議的錄音將於太平洋時間今天下午 5 點前發佈在我們的網站上。接下來，我想把電話交給克里斯。

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us.

謝謝你，卡洛琳。各位下午好，感謝各位的參與。

Q3 was another step forward in our win-in-MRD strategy. We delivered 4,388 clinical tests, a 26% sequential and 364% year-over-year growth, and now have 700+ physicians ordering NeXT Personal. We also submitted lung cancer for coverage, and we now have three dossiers under review by MolDx as we continue to target two coverage decisions in 2025. Our clinical evidence from recent Phase 3 programs in the CA trial launch shows how ultra sensitivity can detect progression several months before imaging and provide greater confidence in a negative result. While biopharma project timing continues to have variability, the underlying MRD demand is strong, clinical adoption is compounding, and our cache position gives us the flexibility to execute.

第三季是我們贏得 MRD 策略的又一步。我們完成了 4,388 項臨床測試，季增 26%，年增 364%，目前已有 700 多名醫生訂購 NeXT Personal。我們也提交了肺癌的保險申請，目前 MolDx 正在審查我們的三份申請，我們的目標是在 2025 年獲得兩項保險批准。我們在 CA 試驗啟動的近期 3 期計畫中獲得的臨床證據表明，超高靈敏度可以在影像前幾個月檢測到病情進展，並能為陰性結果提供更大的信心。儘管生物製藥計畫的進度安排仍然存在不確定性，但潛在的 MRD 需求強勁，臨床應用正在不斷增加，而我們的庫存狀況使我們有靈活性來執行。

For those listening in for the first time, Personalis is a leading company helping partners, patients, and doctors see more in cancer samples. Our ultra-sensitive NeXT Personal test is capable of detecting approximately one single fragment of tumor DNA in a million. This is not merely an improvement. It is a clinical necessity that allows us to detect recurrence months ahead of standard imaging and provides more confidence in a negative result. The market is growing rapidly for these types of tests and is expected to mature into a $20 billion opportunity for which we are exceptionally well-positioned to command a strong share.

對於第一次收聽的人來說，Personalis 是一家領先的公司，致力於幫助合作夥伴、患者和醫生從癌症樣本中發現更多。我們超靈敏的 NeXT Personal 檢測能夠檢測到百萬分之一的腫瘤 DNA 片段。這不僅僅是一種改進。這是臨床上的必要手段，它使我們能夠在標準影像檢查之前數月檢測到復發，並增強對陰性結果的信心。這類檢測的市場正在迅速成長，預計將發展成為一個價值 200 億美元的市場，而我們擁有得天獨厚的優勢，能夠佔據相當大的市場份額。

We're also a leader supporting biopharma companies with our discriminating platform, and that is used to analyze cancer tumors and identify new biomarkers. Our platforms are used to build personalized therapies and allow physicians to personalize treatment for cancer patients. Now turning to our Q3 results, we delivered $14.5 million in revenue in the quarter, which was above the high end of our estimates. Our progress this quarter is best highlighted by our clinical volume. We reported 4,388 tests this past quarter, representing a 26% growth over the previous quarter. To put that in context, it's worth pausing to note we did just 945 tests in the third quarter of last year, and our performance this quarter reflects a 364% year-over-year growth.

我們也是生物製藥公司領先的支援力量，我們擁有獨到的平台，用於分析癌症腫瘤並識別新的生物標記。我們的平台用於建立個人化療法，使醫生能夠為癌症患者制定個人化治療方案。現在來看看我們第三季的業績，該季度我們實現了 1,450 萬美元的收入，高於我們預期的上限。本季我們的進展最能體現在我們的臨床病例數上。上個季度我們報告了 4,388 次檢測，比上個季度增加了 26%。為了更好地理解這一點，值得一提的是，去年第三季度我們只進行了 945 次測試，而本季的業績反映了同比增長 364%。

And cumulative to date, we've delivered more than 13,000 tests to help patients.

截至目前，我們累計已為患者提供了超過 13,000 次檢測。

We're providing an updated range for full year revenue in the $68 to $73 million dollar range. The uneven biopharma spending environment we discussed last quarter has persisted, creating continued variability in the timing of large project-based work. While the underlying demand for our strategic MRD offerings remain exceptionally strong. This quarter, the biopharma volatility is compounded by logistical delays we believe are unique to this quarter and are impacting the timing of samples for several large projects. This increases the variability of our Q4 biopharma revenue. As a result, we are prudently adjusting our full-year guidance to reflect these updated project timelines. This adjustment does not reflect a change in underlying demand for our technology and offerings, but rather the lumpy and unpredictable nature of our legacy translational research business.

我們給出的全年營收預期範圍更新為 6,800 萬至 7,300 萬美元。我們在上個季度討論的生物製藥支出環境不均衡的狀況依然存在，導致大型專案工作的進度持續不穩定。儘管市場對我們策略性 MRD 產品的基本需求依然非常強勁。本季度，生物製藥行業的波動性因物流延誤而加劇，我們認為這是本季度特有的情況，並且正在影響幾個大型專案的樣品交付時間。這將增加我們第四季生物製藥收入的波動性。因此，我們正在謹慎地調整全年業績預期，以反映這些更新後的專案時間表。這項調整併不反映出對我們技術和產品的潛在需求發生了變化，而是反映了我們傳統轉化研究業務的波動性和不可預測性。

And while we manage the variability with discipline, our strategic focus remains squarely on the key drivers of long-term value clinical adoption and reimbursement. On that front, we continue to execute strongly. We advanced our goals this quarter by submitting an additional indication for coverage lung cancer, meaning we now have three dossiers under review with MolDx.

雖然我們以嚴謹的態度來應對各種變化，但我們的策略重點仍然完全放在長期價值臨床應用和報銷的關鍵驅動因素上。在這方面，我們持續保持強勁的執行力。本季度，我們透過提交肺癌的額外適應症，推進了我們的目標，這意味著我們現在有三份文件正在接受 MolDx 的審查。

We remain confident in our data and continue to target coverage for two indications by the end of the year though exact timing is dependent on MolDx's review. Our progress this quarter is a direct result of the execution of the key pillars of our win-in-MRD strategy. Now let's walk through the updates.

我們對我們的數據仍然充滿信心，並繼續以年底前涵蓋兩種適應症為目標，但具體時間取決於 MolDx 的審查。本季的進展是我們贏得市場需求策略關鍵支柱執行的直接結果。現在我們來逐一了解更新內容。

The first pillar is accelerating clinical adoption. The oncology community is voting with their orders. We continue to see impressive sequential growth in clinical test volumes. We now have over 700 physicians ordering NeXT Personal, and this growing base of physicians understands that when it comes to residual disease, ultra-sensitivity matters. Our retention is high, and the growth we are seeing is a direct result of NeXT Personal providing greater confidence in a negative result and the ability to detect recurrence earlier than any alternative. The clinical volume growth is the single most important leading indicator of our future. High-margin revenue ramp as reimbursement comes online. This momentum is being driven by our partnership with Tempest, which continues to exceed our expectations. The collaboration has been so effective that we've already achieved the primary volume target we set for the entire year. When we set our targets at the beginning of the year, our goal was to grow 30 to 40% each quarter, ending the year with around 4,800 quarterly tests. We've effectively reached that milestone a quarter early, and having achieved our goal ahead of schedule, our focus for the rest of the year now shifts to responsibly scaling our operational and commercial foundation. Additionally, we're strategically expanding our in-house sales force to complement the Tempest team to ensure we are fully prepared to capitalize on the inflection point of Medicare coverage. The second pillar is driving reimbursement and adoption through clinical evidence. We're proud of the latest NeXT Personal data from AstraZeneca's Phase 3 studies.

第一支柱是加速臨床應用。腫瘤學界正在用他們的醫囑投票。臨床試驗數量持續呈現令人矚目的成長動能。現在已有超過 700 位醫生訂購了 NeXT Personal，而且不斷增長的醫生群體也明白，對於殘留病灶而言，超高靈敏度至關重要。我們的客戶留存率很高，我們看到的成長是 NeXT Personal 提供的更可靠的陰性結果和比任何其他方法更早發現復發能力的直接結果。臨床病例量的成長是我們未來最重要的領先指標。隨著報銷機制的上線，高利潤收入將迅速成長。這一發展勢頭得益於我們與 Tempest 的合作，而 Tempest 的表現也持續超出我們的預期。此次合作非常成功，我們已經實現了全年設定的主要銷售目標。年初我們設定目標時，目標是每季成長 30% 到 40%，到年底達到每季約 4800 次測試。我們實際上提前一個季度達到了這一里程碑，並且提前實現了目標，因此今年剩餘時間的重點將轉移到負責任地擴大我們的營運和商業基礎。此外，我們正在策略性地擴大內部銷售隊伍，以補充 Tempest 團隊，確保我們做好充分準備，抓住 Medicare 覆蓋範圍的轉折點。第二大支柱是透過臨床證據推動報銷和推廣。我們為阿斯特捷利康3期研究中最新的NeXT Personal資料感到自豪。

First, in neoadjuvant lung cancer, data from the Neo-Adorra Phase 3 trial was presented at the World Conference on Lung Cancer that demonstrated the superiority of NeXT Personal in the [neoadjuvant] setting.

首先，在新輔助肺癌治療方面，Neo-Adorra 3 期試驗的數據在世界肺癌大會上公佈，證明了 NeXT Personal 在新輔助治療中的優越性。

NeXT Personal showed significantly higher baseline sensitivity for ctDNA detection compared to a leading gene mutation-based test, offering physicians a more accurate assessment of disease burden and the ability to monitor treatment response. The data also showed that our test was prognostic for outcomes across treatment arms.

與領先的基於基因突變的檢測方法相比，NeXT Personal 在 ctDNA 檢測方面表現出更高的基線靈敏度，為醫生提供了更準確的疾病負擔評估和監測治療反應的能力。數據還表明，我們的測試能夠預測各個治療組的結果。

Second, in the adjuvant EGFR-mutated lung cancer, further data from the Phase 3 Laura trial was presented at ESO, which showcased the utility of NeXT Personal for treatment monitoring. Our assay demonstrated a medium lead time of 5 months in detecting MRD progression ahead of imaging and standard expert review. Lead time is a difference maker for patients, underscoring the value of an ultra-sensitive approach for earlier intervention.

其次，在輔助治療 EGFR 突變肺癌方面，ESO 展示了 3 期 Laura 試驗的更多數據，該試驗展示了 NeXT Personal 在治療監測方面的實用性。我們的檢測方法顯示，在影像學檢查和標準專家審查之前，檢測 MRD 進展的中等提前時間為 5 個月。提前治療時間對患者來說至關重要，凸顯了採取超敏感方法進行早期介入的價值。

These studies demonstrate how our biopharma partners are utilizing ultra-sensitive MRT testing with NeXT Personal to better understanding response to therapy and their Phase 3 studies. In addition to these results, We are excited to announce the launch of the Kate clinical trial with the Yale Cancer Center and the Translational Breast Cancer Research Consortium. This perspective multi-center trial is a step towards establishing clinical utility for CTDNA guided treatment and high-risk HR positive HER2 negative breast cancer.

這些研究表明，我們的生物製藥合作夥伴正在利用 NeXT Personal 的超靈敏 MRT 檢測來更好地了解治療反應及其 3 期研究。除了這些結果之外，我們很高興地宣布與耶魯癌症中心和轉化乳癌研究聯盟共同啟動 Kate 臨床試驗。這項多中心試驗旨在確立 CTDNA 指導治療和高風險 HR 陽性 HER2 陰性乳癌的臨床應用價值。

This study is designed to generate evidence that will help integrate NeXT Personal into the standard of care, empowering oncologists to move from surveillance. To preemptive treatment based on our ultra-sensitive detection.

這項研究旨在產生證據，以幫助將 NeXT Personal 整合到標準護理中，使腫瘤科醫生能夠從監測轉向治療。基於我們超靈敏的檢測技術進行預防性治療。

The third pillar is leading with biopharma partners. Our technology offers our partners a powerful way to improve their clinical trials.

第三大支柱是與生物製藥合作夥伴攜手。我們的技術為合作夥伴提供了一種強有力的手段來改進他們的臨床試驗。

The use of our NeXT Personal technology allows them to de-risk their pipelines, reach critical go/ no-go decisions sooner, and enroll the right patients for their studies. We believe this leads to improved financial performance for our customers, cementing the value of our ultra-sensitive approach. As a result, the underlying demand for NeXT Personal and clinical trials has never been higher. We capitalize on this demand by signing two major prospective clinical trials this quarter. As mentioned before, our MRD biopharma revenue is set to go approximately 300% year-over-year. As we wind up the year, Personalis is executing with precision on a winning strategy. Just 2 years ago, we launched Next Personnel and started our journey to redefine the MRD market with an ultra-sensitive approach. We made tremendous progress in this time, having built a network of over 700 physicians and numerous collaborators and biopharma partners adopting NeXT Personal.

使用我們的 NeXT Personal 技術，他們可以降低研發管線的風險，更快地做出關鍵的推進/終止決策，並為他們的研究招募合適的患者。我們相信這將為我們的客戶帶來更好的財務業績，鞏固我們超敏感方法的價值。因此，市場對 NeXT Personal 和臨床試驗的潛在需求從未如此高。我們抓住這項市場需求，在本季簽署了兩項重要的前瞻性臨床試驗。如前所述，我們的 MRD 生物製藥收入預計將年增約 300%。在這一年即將結束之際，Personalis 正精準地執行著一項致勝策略。僅僅兩年前，我們推出了 Next Personnel，開始了我們以極其敏感的方式重新定義 MRD 市場的旅程。在此期間，我們取得了巨大的進步，建立了一個由 700 多名醫生和眾多合作者及生物製藥合作夥伴組成的網絡，他們都採用了 NeXT Personal。

I want to thank our shareholders, partners, and employees for their dedication and commitment to the mission as we redefine the standard of care for cancer patients. With that, I will turn it over to Aaron to review our financial results.

我要感謝我們的股東、合作夥伴和員工，感謝他們對我們使命的奉獻和承諾，讓我們能夠重新定義癌症患者的照護標準。接下來，我將把工作交給亞倫，讓他來審核我們的財務表現。

Thank you, Chris. I will discuss our 3rd Quarter, 2025 results and then cover guidance.

謝謝你，克里斯。我將討論我們2025年第三季的業績，然後介紹業績展望。

Total company revenue for the third quarter was $14.5 million, representing a 44% decrease compared with $25.7 million for the same period of the prior year.

該公司第三季總營收為 1,450 萬美元，與上年同期的 2,570 萬美元相比下降了 44%。

The decrease in revenue was driven by the expected decline of $4.6 million from Terra as we wind down this business, a $4.2 million decline from VAMBP due to fulfilling most of the task order received in 2024 within the first two quarters of this year and a $2.5 million decline from biopharma customers.

收入下降的原因有三：一是 Terra 預計收入下降 460 萬美元（因為我們正在逐步結束這項業務）；二是 VAMBP 預計收入下降 420 萬美元（因為我們在今年前兩個季度完成了 2024 年收到的大部分任務訂單）；三是生物製藥客戶預計收入下降 250 萬美元。

Biopharma revenue was 13.2 million in the quarter, representing a 16% decrease compared with $15.7 million for the same period of the prior year.

本季生物製藥收入為 1,320 萬美元，與去年同期的 1,570 萬美元相比下降了 16%。

This decline was primarily due to the prior year, including a significant amount of revenue from Moderna's Phase 3 melanoma trial that concluded enrollment late last year.

這一下滑主要是由於前一年，其中包括 Moderna 的 3 期黑色素瘤試驗的大量收入，該試驗於去年年底結束了招募工作。

The third quarter of 2025, year-over-year revenue declined from Moderna to $6.1 million and was partially offset by the increase in NeXT Personal MRD revenue from several BioPharma customers and accounted for more than a third of the total biopharma revenue in the quarter.

2025 年第三季度，Moderna 的營收年減至 610 萬美元，部分被幾家生技製藥客戶帶來的 NeXT Personal MRD 收入的成長所抵消，佔該季度生物製藥總收入的三分之一以上。

We are pleased with the adoption of next personnel that is taking place, and it highlights the solid execution of our win and MRD strategy.

我們對正在進行的下一批人員的聘用感到滿意，這凸顯了我們贏得市場和市場研發策略的實際執行。

For clinical revenue, we recognized $0.4 million of revenue from our NeXT Dx and NeXT Personal molecular tests, compared with $0.3 million for the same period of the prior year.

在臨床收入方面，我們從 NeXT Dx 和 NeXT Personal 分子檢測中確認了 40 萬美元的收入，而去年同期為 30 萬美元。

Gross margin was 13.2% in the third quarter, compared with 34% for the same period of the prior year. The year-over-year decrease of 20.8% was expected and primarily due to the 44% lower revenue volume, which reduced the amount of fixed-cost absorption, and also an increase in clinical test costs in advance of reimbursement.

第三季毛利率為 13.2%，去年同期為 34%。年比下降 20.8% 是意料之中的，主要原因是收入下降了 44%，導致固定成本吸收減少，以及報銷前的臨床試驗成本增加。

The third-quarter impact from our investments in unreimbursed clinical test costs was approximately 18%, and excluding those expenses, gross margin would have been approximately 31%. We are being prudent in balancing test volume and margin dilution.

第三季度，我們對未報銷的臨床試驗成本的投資影響約為 18%，如果排除這些費用，毛利率約為 31%。我們在平衡測試量和利潤率稀釋方面採取了謹慎的態度。

And looking a bit further out in time, we expect the investments and test volume to put us in position to achieve a higher level of revenue once reimbursement is obtained.

展望未來，我們預計，一旦獲得報銷，投資和測試量將使我們有能力實現更高的收入水平。

Longer-term, we expect total company margins to expand beyond 50% once we have obtained reimbursement coverage for more than a few indications, and we also achieve greater revenue scale.

從長遠來看，我們預計一旦我們獲得更多適應症的報銷，並且實現更大的收入規模，公司總利潤率將擴大到 50% 以上。

Operating expenses were $25.2 million in the third quarter compared with $23.1 million for the same period of the prior year.

第三季營運支出為 2,520 萬美元，而上年同期為 2,310 萬美元。

Most of the year-over-year increase was attributed to selling expenses related to our clinical test volume growth.

年比增幅主要歸因於與臨床測試量成長相關的銷售費用。

The third quarter R&D expense was $12.2 million compared with $11.7 million for the same period of the prior year and SG&A expense was $13 million compared with $11.4 million for the same period of the prior year.

第三季研發費用為 1,220 萬美元，而上年同期為 1,170 萬美元；銷售、管理及行政費用為 1,300 萬美元，而上年同期為 1,140 萬美元。

Net loss for the third quarter was $21.7 million compared with $39.1 million for the same period of the prior year. The prior year's net loss included the $26 million non-cash expense related to the warrants issued to Tempest that were exercised in the third quarter of last year.

第三季淨虧損為 2,170 萬美元，而上年同期淨虧損為 3,910 萬美元。上一年度的淨虧損包括與去年第三季向 Tempest 發行的認股權證相關的 2,600 萬美元非現金支出，這些認股權證已行使。

Now onto the balance sheet. We finished the third quarter with a strong balance sheet, with cash and short-term investments of $150.5 million and no debt other than some small equipment loans.

接下來來看資產負債表。第三季末，我們的資產負債表表現強勁，現金和短期投資達 1.505 億美元，除一些小型設備貸款外，沒有其他債務。

The cash usage from operations and capital equipment additions for the third quarter was $23.4 million.

第三季營運現金支出和資本設備新增支出為 2,340 萬美元。

We expect to use approximately $75 million for the full year of 2025 and end the year with more than $130 million of cash on our balance sheet.

我們預計 2025 年將全年使用約 7,500 萬美元，並在年底時資產負債表上的現金餘額超過 1.3 億美元。

The cash usage estimate has remained the same throughout the year, while our revenue estimate at the midpoint has declined by approximately 17% from the original range.

全年現金使用量估算維持不變，而收入估算中位數較原先的範圍下降了約 17%。

This is a critical proof point of our financial and operational discipline.

這是我們財務和營運紀律的關鍵證明。

It demonstrates that as market conditions have shifted, we have proactively managed over $14 million in spending to fully offset the revenue variances — ensuring we continue to fund our most important strategic investments while holding our bottom-line cash commitments to our investors.

這表明，隨著市場狀況的變化，我們積極主動地管理了超過 1400 萬美元的支出，以完全抵消收入差異，從而確保我們繼續為最重要的策略投資提供資金，同時履行對投資者的現金承諾。

Now I'd like to turn to guidance. For the full year of 2025, we revised our guidance and now expect total company revenue in the range of $68 to $73 million, as we reduced the range from the prior guidance of $70 to $80 million.

現在我想請教各位指導意見。對於 2025 年全年，我們修改了預期，現在預計公司總收入將在 6,800 萬美元至 7,300 萬美元之間，因為我們將預期範圍從先前的 7,000 萬美元至 8,000 萬美元下調。

Revenue from pharma tests and services and all other customers in the range of $50 to $54 million, for which the range was reduced from the prior guidance of $52 to 58 million.

來自醫藥檢測和服務以及所有其他客戶的收入在 5,000 萬至 5,400 萬美元之間，此前的預期為 5,200 萬至 5,800 萬美元。

Population sequencing plus enterprise customers in the range of 16.5 to 17 million, an increase from the prior guidance of 15 to 16 million.

人口定序加上企業客戶數量在 1,650 萬至 1,700 萬之間，比先前預期的 1,500 萬至 1,600 萬有所增加。

Revenue from clinical tests reimbursed in the range of $1.5 to $2 million, which is reduced from the prior guidance of 3 to $6 million reflecting that the company has not yet received reimbursement approvals underpinning the previously higher estimate range.

臨床試驗報銷收入預計在 150 萬至 200 萬美元之間，低於先前 300 萬至 600 萬美元的預期，反映出該公司尚未獲得報銷批准，因此先前的預期範圍較高。

Gross margin in the range of 22 to 24%, no change from the prior guidance, and reflects investments in clinical test volume in advance of reimbursement.

毛利率在 22% 至 24% 之間，與先前的預期一致，反映了在獲得報銷之前對臨床試驗數量的投資。

Net loss of approximately $85 million, no change from the prior guidance, and cash usage of approximately $75 million. With no change from the prior guidance, we look forward to updating you on our progress during the next conference call in a few months, and with that, I will turn the call back over to the operator to begin the Q&A session, operator.

淨虧損約 8,500 萬美元，與先前的預期一致；現金使用量約 7,500 萬美元。與先前的指導意見相同，我們期待在幾個月後的下次電話會議上向您報告我們的進度。接下來，我將把電話交還給接線員，開始問答環節。接線生

Thank you.

謝謝。

[Operator instruction]

[操作說明]

Our first question is from Thomas Flaten with Lake Street Capital Market.

我們的第一個問題來自 Lake Street Capital Market 的 Thomas Flaten。

Thank you. Hey, Chris, you mentioned in the last quarter call there were a couple of very large customers kind of on the cusp of coming online with you. Could you give us an update on those?

謝謝。嘿，克里斯，你在上個季度的電話會議上提到，有幾個非常大的客戶即將與你們合作上線。您能為我們提供一下這些專案的最新進展嗎？

Yeah, they both come online. One of them was a big driver of our Q3 numbers. I don't know if you noted that, almost a third of our revenue now came from MRD this last quarter that was directly driven by one of those customers, and the other one had some revenue in this quarter and then it'll bleed into the Q4. So those are still on track and we are still. Growing MRD revenue 3 times this year and the demand for our MRD technology has been super high and it's been a really good quarter. One of the things we also noted, and we can't announce the names of them yet, but we, we've signed two large prospective clinical trials that will start to kick in and be serviced over the next 2 to 3 years with biopharma customers. So, we continue this year to make really promising. Progress with biopharma customers in terms of MRD adoption.

是的，他們兩個都上線了。其中一位是我們第三季業績的主要動力。我不知道您是否注意到，上個季度我們近三分之一的收入來自 MRD，這主要得益於其中一位客戶的直接推動；另一位客戶在本季度也獲得了一些收入，這部分收入將會延續到第四季度。所以這些項目仍在按計劃進行，我們仍在繼續。今年 MRD 營收成長了 3 倍，市場對我們 MRD 技術的需求非常高，這是一個非常好的季度。我們還注意到一件事，雖然現在還不能透露具體名稱，但我們已經與生物製藥客戶簽署了兩項大型前瞻性臨床試驗協議，這兩項協議將在未來 2 到 3 年內開始實施並提供服務。所以，今年我們將繼續努力，爭取取得非常好的成績。在 MRD 採用方面與生物製藥客戶取得進展。

That's great. And Chris, your prepared comments today, you said something about a logistical delay specific to this sector. Could you clarify what you meant by that?

那太棒了。克里斯，你今天準備好的發言稿中提到了該行業特有的物流延誤問題。您能解釋一下您這話是什麼意思嗎？

Yeah, so we've had some samples run into problems at customs. I mean, one of the challenges with the businesses it's constructed now is that it's almost all revenue from biopharma customers and those are based on large cohorts and so in larger million dollar plus studies, so one or two things, having some hiccups or some challenges along the way. And cause us some a lot of variability. We've had some challenges getting samples across the border. We don't know whether that is due to the government shutdown, H1, Thomas, or whether that's something else. We know there's been some other challenges. With getting things over, we've had one sample cohort be turned around. We're going to try to get it back in. So, we thought it was really prudent to just make the range wider on the bottom end in case those samples don't end up making an inherent time to run them in Q4 in that case they'll slip into Q1 and that's what accounts for the challenge and we said it was unique to this quarter. We always have some challenges getting samples, but we haven't run into problems before at customs like this. And so, that's we think that's probably related to what's happening with the shutdown where there's probably a bit less staffing and, some paperwork isn't done proper, it may get turned back and so we're still working on it we're still optimistic everything will flow in here, but we just wanted to be prudent and create a wider range.

是的，我們的一些樣品在海關遇到了問題。我的意思是，它現在構建的業務面臨的挑戰之一是，其收入幾乎全部來自生物製藥客戶，而這些客戶都是基於大型隊列研究，也就是耗資數百萬美元以上的大型研究，因此，一兩個問題，在這個過程中，難免會遇到一些小問題或挑戰。並為我們帶來了很多變數。我們在將樣品運過邊境時遇到了一些困難。我們不知道這是由於政府停擺、H1、托馬斯，還是其他原因造成的。我們知道還存在其他一些挑戰。隨著事情的進展，我們已經扭轉了一個樣本隊列的局面。我們會想辦法把它裝回去。所以，我們認為，為了以防萬一這些樣品最終沒有在第四季度完成運行，從而導致它們滑落到第一季度，因此，將低端範圍擴大是非常謹慎的做法。這就是挑戰所在，我們說這是本季特有的情況。我們取得樣品總是會遇到一些挑戰，但以前從未在海關遇到這樣的問題。所以，我們認為這可能與停工有關，因為停工期間人手可能不足，有些文件沒有正確填寫，可能會被退回。所以我們仍在努力，仍然樂觀地認為一切都會順利進行，但我們只是想謹慎一些，並擴大範圍。

Excellent. Thanks for taking the questions.

出色的。謝謝您回答問題。

Thank you. Our next question is from Mark Massaro with BTIG.

謝謝。下一個問題來自 BTIG 的 Mark Massaro。

Hey guys, thank you for taking the questions. Yeah, great to see the progress. I just wanted to start, and I apologize if this is nitpicky. The Next Personal growth was just a hair shy of your previously communicated 30% to 40% a quarter growth, coming in at 26%. I'm just curious if. That is largely due to you metering or tempering demand ahead of reimbursement, or did you see anything in the field that might have surprised you? Obviously, this is a competitive space, so I was just curious or if there are some other timing elements, any clarity there would be helpful.

各位，謝謝你們回答問題。是的，很高興看到取得進展。我只是想開始而已，如果我的問題太吹毛求疵，請見諒。下一次個人成長與先前公佈的每季 30% 至 40% 的成長相比略有差距，實際成長為 26%。我只是好奇是否如此。這主要是因為你在報銷前對需求進行了計量或控制，還是你在現場看到了什麼讓你感到驚訝的事情？顯然，這是一個競爭激烈的領域，所以我只是好奇，或者是否有其他時間安排方面的因素，任何澄清都將有所幫助。

No, I appreciate it. Thanks for flagging it, Mark. When we said 30 to 40% at the beginning of the year, the goal was, to end the year in that 4,800. Test mark and you know we’re largely there so I wouldn't say we need her per se, but we definitely were very careful and are being very careful to manage the investment here. I mean we're investing a lot of money ahead of reimbursement and building demand, building usage, building KOLs, So we’ve kind of rolled into where we wanted to be and so yeah we were we were thoughtful this quarter I think you know Tempest said something similar ahead of reimbursement being careful and we we also did that and did that in conjunction with them. Third quarter is always a tougher quarter mark in terms of volume being, flat. Q2 and Q4 are always the big quarters in the clinical business, and so we didn't. We didn't really grow into it. So that's sort of the seasonality that we typically see, but we didn't respond by throwing more resources at it. I will say that, we will continue to be thoughtful about managing it in the context of the demand, in the context of demand. We feel like we’re in a really good spot, we're in a really good spot. We'll be where we want it to be in the new year.

不，我很感激。謝謝你提醒，馬克。年初我們說要達到 30% 到 40%，目標是到年底達到 4800。測試結果顯示，我們基本上已經達到了目標，所以我不會說我們本身需要她，但我們過去和現在都非常謹慎地管理著這筆投資。我的意思是，我們在報銷之前投入了大量資金，用於建立需求、提高使用率、培養關鍵意見領袖，所以我們已經基本達到了我們想要的目標。是的，我們這個季度一直很謹慎。我想你知道，Tempest 在報銷之前也說過類似的話，要謹慎行事，我們也這樣做了，並且與他們一起做了這件事。第三季度通常是銷量較為平穩的一個季度，因此銷售情況往往比較艱難。第二季和第四季一直是臨床業務的旺季，所以我們沒有這樣做。我們並沒有真正適應它。所以這就是我們通常會看到的季節性現象，但我們並沒有投入更多資源來應對。我想說的是，我們將繼續在需求的大背景下，認真思考如何管理它。我們感覺我們現在處境非常好，我們處境非常好。新的一年，我們將達到我們想要的目標。

Okay, and I think you lowered the guidance on the clinical revenue contribution here in Q4, and I just want to ask, what gives you confidence that, maybe if you could characterize your conversations with MolDx just a little bit at a high level, is this still an active review, because I think you talked about still expecting to by year end.

好的，我認為您在第四季度下調了臨床收入貢獻的預期，我想問一下，是什麼讓您有信心，如果您能概括地描述一下您與 MolDx 的對話，這是否仍然是一項積極的審查，因為我認為您提到仍然預計在年底前完成。

It is, I mean, we still have, we have 3 and now we've had productive conversations with MLex, you know that those are always a combination of voice, but also there's a back and forth process with written questions, and we're, we find that to be we're in a very encouraging spot, but we have and we are expecting.

我的意思是，我們仍然有，我們有 3 個，現在我們已經與 MLex 進行了富有成效的對話，你知道，這些對話總是語音和書面問題相結合的過程，我們發現我們處於一個非常令人鼓舞的位置，但我們有並且期待著。

We have all 3 moving along and they're all moving along really well and so we continue to feel like we're on track, Mark, to get 2 of those done this year, and there can always be some variability because the we don't control Mex's final clock , and one of the things that I think we all admire about what they do and the work they do is the seriousness for which they do it and really understanding all the details of the clinical question, studies and so there could be more questions that cause more back and forth, but we think where we are right now and based on where we are, we think we're in a really good spot. That's why we still feel like we're on track to get two done.

這三個項目都在順利進行，進展非常順利，所以我們仍然覺得我們正按計劃推進，馬克，今年可以完成其中兩個項目。當然，進度總是會有一些變數，因為我們無法控制墨西哥的最終時間表。我認為我們都很欣賞他們所做的工作，他們對待工作的認真態度，以及對臨床問題和研究細節的深刻理解。所以，未來可能還會出現更多問題，導致更多的反覆討論，但我們認為，就目前的情況而言，我們處於非常有利的位置。這就是為什麼我們仍然覺得我們能夠按計劃完成兩項任務。

I would note that when we threw this out there a couple years ago it was a really ambitious target, and as we've come down to the spot, we've made tremendous progress and we really de-risked it, and it was a really big deal this quarter to have a one paper basically accepted. Now to have all three accepted and through the peer review process and be able to have the dossiers and be able to be in that journey is exactly where we want it to be, so we feel like we're in a good spot in these conversations have been positive and productive, and we're optimistic about where we are.

我想指出的是，幾年前我們提出這個目標時，它確實是一個非常雄心勃勃的目標，但隨著我們一步步走到今天，我們取得了巨大的進步，也大大降低了風險，本季度有一篇論文基本上被接受，這真的是一件大事。現在，這三篇論文都已通過同行評審，我們擁有了完整的檔案，能夠踏上這段旅程，這正是我們所希望的。因此，我們感覺目前的情況很好，這些對話積極而富有成效，我們對現狀感到樂觀。

Great. And if I could ask one last one, maybe as it relates to MRD BioPharma, I would love to appreciate some of the metrics you provided obviously there's a lot of demand, admittedly it's off of a low base, but can you just talk about what feedback you're hearing from biopharma with respect to going down to 1 part per million. And how you think that's resonating on some of these, lower shedding cancers, and just give us a sense for how you're thinking about 2026 and 2027 if you can.

偉大的。如果我可以問最後一個問題，也許與 MRD BioPharma 有關，我很想了解您提供的一些指標，顯然需求很大，誠然，它的基數很低，但您能否談談您從生物製藥行業聽到的關於降至百萬分之一的反饋？您認為這會對某些癌症（例如低脫落癌症）產生怎樣的影響？如果您可以的話，也請您談談您對 2026 年和 2027 年的看法。

Yeah, no, thanks for asking. It's, I mean, and I think it's more than just the lower shedding cancers, H1stly, Mark. What we hear from biopharma companies is there's really 3 things they want, but there's a focus on 2. 1st of all, they want to fail faster on earlier stage trials, and the key to that is being able to see quickly. Whether or not there is a signal because of the drug and getting down and being able to see something to 1 part per million, the 40% of our positive results are inside that range, so they can just see it faster, fail faster, and pull out of an early-stage trial.

不，謝謝關心。我的意思是，而且我認為這不僅僅是低脫落性癌症的問題，首先，馬克。我們從生物製藥公司了解到，他們實際上想要三件事，但重點放在兩件事上。首先，他們希望在早期試驗中更快發現問題，而關鍵在於能夠快速發現問題。無論藥物是否能產生訊號，無論濃度是否達到百萬分之一，我們 40% 的陽性結果都在這個範圍內，所以他們可以更快地發現問題，更快地失敗，並退出早期試驗。

That's key right now for them and where they can use it. Later stage projects getting to success faster means we can get the drugs in the hands of patients quicker. And again, when you can see the recurrence months ahead of imaging or any other approach, that's really powerful in order to get to the answer quicker and be able to yield more revenue on it. The last clinical use, quite frankly, is being able to enroll the right patients in the clinical trial where they use an MRD assay to be able to decide whether to put a patient in a treatment arm or not a treatment arm, and you really want to have confidence that when you call a patient negative, they're likely negative because That is enriching for success, and you really want to get that metric well. There's been some challenges in the past around doing that really well for them, and so we get really positive feedback with that. So those are the things 123, I will say they are the most discriminating buyers.

這對他們來說至關重要，也是他們能夠運用這項技術的地方。後期計畫更快取得成功意味著我們可以更快地將藥物送到患者手中。再次強調，如果能在影像檢查或其他任何方法出現之前幾個月就發現復發，那將非常有助於更快地找到答案，並從中獲得更多收益。坦白說，最後一個臨床用途是能夠招募合適的患者參加臨床試驗，他們使用 MRD 檢測來決定是否將患者納入治療組或非治療組。你真的希望當你宣布患者為陰性時，他們很可能就是陰性，因為這有利於成功，你真的希望能很好地掌握這個指標。過去，我們在為他們做好這件事上遇到了一些挑戰，因此我們得到了非常正面的回饋。所以，這就是我要說的123件事，他們是最挑剔的買家。

They put us through all kinds of checklists every time we do something. We run a lot of pilots, a lot of bake-offs that we wouldn't be having the kind of success we were having if we weren't performing and if we weren't building a global presence to be able to service these companies' needs. And so, if you back up, it was just 2 years ago we launched this test. Ability to go from that to starting to run large perspective clinical trials with some big biopharma companies is a big leap forward, and I think this is going to pay dividends in 2026 and 2027 and beyond. It's a really nice way to get paid for all the tests. It really helps us build the clinical evidence and you saw the data, we talked about the data at ESO this year and Worldlong with AstraZeneca, where they talked about the use of ultrasensitive testing and inside two clinical trials. And that really helps underline and cement the approach that we're pioneering, and so, it's, we feel like it'll be a continued clinical evidence pipeline and revenue growth over the next couple years.

每次我們做事，他們都會讓我們按照各種各樣的清單進行檢查。我們進行了許多試點項目，進行了很多烘焙比賽，如果我們不努力，如果我們不建立全球影響力來滿足這些公司的需求，我們就不會取得現在這樣的成功。所以，如果把時間倒推，我們啟動這項測試才兩年。從目前的情況發展到能夠與一些大型生物製藥公司合作進行大規模的前瞻性臨床試驗，這是一個巨大的飛躍，我認為這將在 2026 年、2027 年及以後帶來回報。這是個非常好的測試報酬方式。它確實幫助我們建立了臨床證據，你們也看到了數據，我們今年在歐洲南方組織 (ESO) 和與阿斯利康合作的 Worldlong 大會上討論了這些數據，他們談到了超靈敏檢測在兩項臨床試驗中的應用。這確實有助於強調和鞏固我們正在開創的方法，因此，我們感覺到未來幾年臨床證據管道和收入將持續成長。

Fantastic, thanks very much.

太棒了，非常感謝。

Thanks, Mark.

謝謝你，馬克。

Our next question comes from Dan Brennan with TD Cowen.

下一個問題來自 TD Cowen 公司的 Dan Brennan。

Great, thank you. Thanks for the questions. Sorry, during a few seconds, a few minutes late. So is the government shutdown having any impact on MLex? Like are they short staffed? Is that a factor? I don't know if you mentioned that.

太好了，謝謝。謝謝大家的提問。抱歉，稍等片刻，晚了幾分鐘。那麼政府停擺對MLex有影響嗎？他們是不是人手不足？這是一個因素嗎？我不知道你有沒有提過這一點。

We haven't seen it.

我們還沒見過。

Yet, H1stly, we've been able to have the back and forth and we don't see anything. I think all of us, just H1stly I've, I'm always surprised the little nooks and crannies of things that pop up with this government shutdown. So you never know what the future holds, but I, but right now we haven't seen it. They seem to be working well. Remember it's a private company that's been given the contract to both pay claims in the territory they have, but also make decisions about molecular genetic testing, these types of tests that many of the acts in the country that many but not all defer to, so because it's a private company with a contract. We, we're not surprised that we don't see any impact from it.

然而，首先，我們已經進行了來回溝通，但我們什麼也沒看到。我想我們所有人，尤其是我自己，總是對這次政府停擺時冒出來的各種小細節感到驚訝。所以你永遠無法預知未來，但就目前而言，我們還沒有看到未來。它們似乎運作良好。請記住，這是一家私人公司，它獲得了在其管轄區域內支付索賠的合同，同時也對分子遺傳檢測做出決定。這類檢測是該國許多法案所依據的，但並非所有法案都遵循這些法案。因此，因為它是一家擁有合約的私人公司。我們並不驚訝它沒有產生任何影響。

Got it. No thanks, Chris. And then can you just remind us, I know, we met with another company that also has some filings with Moldex, and they were referring to like standard cycle. So there's a cadence to how many turns this could occur. I mean, can you just remind us, I know when we had you in New York not long ago, just in terms, I think you filed breast in April, is there a certain normal cadence that occurs like are you in the midst of a second turn or 3rd turn or 4th turn just kind of walk us through like what the normal sequence of back and forth is if there's like a routine to that and kind of where you guys sit.

知道了。不用了，克里斯。然後您能否提醒我們一下，我知道，我們曾與另一家公司會面，該公司也向 Moldex 提交了一些文件，他們指的是標準週期。所以，這種情況發生的次數是有規律的。我的意思是，你能提醒我們嗎？我知道我們不久前在紐約見過你，就具體情況而言，我想你是在四月提交的乳房手術申請，是否存在某種正常的節奏，例如你是在進行第二輪、第三輪還是第四輪手術？請你給我們介紹一下正常的來回順序，是否存在某種慣例，以及你們通常在哪裡進行手術。

Yeah, Rich is going to jump in.

是的，里奇要加入進來了。

Hey Dan, yeah, thanks for your question. Yeah, there is, and the back and forth that goes on with multi X usually it kind of goes in two month cycles, and so, and that usually results in a set of questions and and response, and it's usually a great dialogue, good questions, and so we're kind of going down that journey, both on the breast cancer side but now also on IO and so lung cancer.

嘿，丹，是的，謝謝你的提問。是的，確實如此，而且多重藥物聯合治療的來回過程通常以兩個月為一個週期，因此，這通常會產生一系列問題和回應，而且通常是很好的對話，提出很好的問題，所以我們正在經歷這個過程，不僅在乳腺癌方面，現在也在免疫腫瘤學和肺癌方面。

Got it. And sorry, Richard, I miss it. Like, is it typically like you start it and then it goes 2 months and then either it gets approved or they go back and then it goes another 2 months. Is there like a a certain finite ending each cycle or it can kind of persist that would give us a sense of where you guys actually sit?

知道了。抱歉了，理查德，我很想念它。例如，通常情況下，是不是先提交申請，然後等兩個月，要么獲得批准，要么被退回，然後再等兩個月？每個週期都有一個確定的終點，還是會持續下去，讓我們了解你們的實際處境？

Yeah, no, I mean, you typically you do the you you send the res you send the submission and and and then there's a 60 days they have to get you the answer back. You may turn then that those are phrased as questions back to you typically about the data about the test, about the essay about its use, about your intended use, etc.

是的，不，我的意思是，通常情況下，你提交結果，然後他們有 60 天的時間給你答案。那麼，你可能會發現這些問題通常是以提問的形式向你提出的，這些問題通常與測驗數據、文章用途、你的預期用途等有關。

You're answering those questions, you can take as long as you want to answer those questions. You can do it overnight or you can do it in a month. And then when you submit those, the clock starts again for 60 days. Got it right.

你在回答這些問題，你可以花你想花的時間來回答這些問題。你可以一夜之間完成，也可以花一個月的時間完成。然後，當你提交這些文件時，計時將重新開始，為期 60 天。答對了。

So. And there could be more questions that could be new?

所以。是否還有其他新的問題？

Yeah, there could be new questions that they could come up with as they continue to pour into the data and find new questions, or there could be questions upon the questions, right? And I think about, it's very much like a process where you go through a, to get a permit in a city, in a planning department where there's questions on what you've done and there can be questions, to your response, etc. And that back and forth is usually gated by By time periods of how long they have to respond to you. So yeah, so we started it earlier in the year in mid breast. We thought that one would take a little longer, so we're probably really optimistic to get that going because that's really their first way to engage with the test and the AV data, analytic validity data, which is sort of key to underpinning it all, and then we, we've got the IO going and and then we've got the the the the lung cancer ones going and so we expect. We've had back and forth on all those, and we expect to get an answer back on all three of them by the end of the year, but the process will go as it goes, but we feel optimistic that we're on track to get a couple of them done this year.

是的，隨著他們不斷深入研究數據，可能會提出新的問題，或者可能會出現問題之外的問題，對吧？我覺得這很像在城市規劃部門申請許可證的過程，他們會問你做了什麼，也會對你的回答提出問題等等。這種來回溝通通常會受到時間限制，規定了他們必須回覆你的時間期限。是的，我們今年早些時候就開始了，當時正值哺乳期。我們原本以為那一項會花更長時間，所以我們對啟動它抱有非常樂觀的態度，因為這實際上是他們參與測試和AV數據（分析有效性數據）的第一個方式，而這對於支撐一切至關重要。然後，我們已經啟動了IO，然後我們啟動了肺癌相關工作，所以我們預計。我們已經就所有這些問題進行了反复討論，預計到今年年底前會得到所有三個問題的答复，但這個過程還要視情況而定，不過我們樂觀地認為，今年我們有望完成其中幾個問題。

And then start one more, and in terms of the confidence this year, obviously it was based upon I guess historical precedent. I mean, I guess, you've got, a handful of companies have gotten approvals. Was there like an expectation it would be two cycles or 3 cycles or the 60 days, or you guys just kind of looked at the predicates and said, if we count forward I'm just wondering since it's November 4th and it's always hard to predict like timing of the government, right, or even if MLex is a private entity, it's always hard to predict the timing.

然後又開始了另一項，至於今年的信心，顯然是基於歷史先例。我的意思是，我想，已經有少數幾家公司獲得了批准。你們之前是不是預期會是兩個週期、三個週期或60天？還是你們只是根據各種因素推算，然後說，如果我們往前推算的話……我只是想知道，因為今天是11月4日，政府的行動時間總是很難預測，對吧？即使MLex是一個私人實體，行動時間也總是很難預測。

There's there's variability. I mean, you remember we put this go out a year and a half ago, and you know we've come a long way to de-risk it, and as we've we've continued to to to to stick with it, it's also based on the strength of the evidence. This is really good data. The tracer X data is probably one of the largest, most comprehensive data sets in MRG, certainly in lung cancer. The data is just phenomenal. The IO study is 200 plus patients, 18 different types of cancer, really nice signal there, and the breast cancer data has been really great also. And so we did it based on the strength of the evidence, what we would expect in the others, but, just to back up, like the goal of whether it leads a little bit into next year happens this year, like none of this is. I, is make or break for the for the trajectory of where we are or what we're trying to do, and we feel like we've made tremendous progress over the last 3 to 4 months on this and de-rising it, and we feel really optimistic sitting here in November.

存在變數。我的意思是，你還記得我們一年半前發布了這個方案嗎？你知道，我們已經採取了很多措施來降低風險，而且我們一直堅持這樣做，這也是基於證據的充分性。這是非常好的數據。示踪劑 X 數據可能是 MRG 中最大、最全面的數據集之一，尤其是在肺癌領域。這些數據簡直太驚人了。IO 研究納入了 200 多名患者，涉及 18 種不同類型的癌症，結果非常好，乳癌數據也非常好。因此，我們根據證據的強度以及我們對其他人的預期來做這件事，但是，為了回到正題，就像它是否會對明年產生一點影響一樣，今年發生的事情，就像這一切都不是真的一樣。這對於我們目前的發展軌跡或我們正在努力的方向至關重要，我們感覺在過去的 3 到 4 個月裡，我們在降低感染率方面取得了巨大的進展，因此，在 11 月份，我們感到非常樂觀。

And maybe final one, like assuming when you do guys do get approval, I know you've been asked this a lot, but now as you get closer to that, and you've had more time and more experience in the field with clinical customers and some pharma customers, how would you think about, like that year one or year two ramp now? Like, what would you point us to to look at it would be just to give us a sense, I mean, obviously you have Tempest, which is a huge commercial engine, but just any updates on how we might think about. Breast, for instance, since that, ideally could be the first one since that's when you file the first, like how that might launch.

最後一個問題，假設你們真的獲得了批准，我知道你們已經被問過很多次了，但現在隨著你們越來越接近目標，並且在臨床客戶和一些製藥客戶領域積累了更多的時間和經驗，你們現在會如何看待第一年或第二年的快速發展階段？例如，您會給我們推薦哪些資料讓我們了解呢？我的意思是，顯然你們有 Tempest，這是一個非常大型的商業引擎，但只是想了解我們應該如何思考這個問題。例如，乳房，因為理想情況下，它可能是第一個，因為那是你提交第一個的時候，就像它可能啟動一樣。

How you might try to, kind of help investors think about that piece of that launch. Thank you.

你可以嘗試幫助投資人思考產品發布中的這一環節。謝謝。

I mean, I, we think that we're early stages here, and you know we think it'll be a really great year on the backside of reimbursement and you know we haven't guided the years here and provided numbers, but you're right, we'll turn tempest fully loose and we'll continue to augment their approach with some sales reps to really sort of augment and really cover the market in nuanced ways to help accelerate what they're doing. And you know we really learned how to do that over the last few months, so it'll continue to take hold, but what's happening at a high level in this market, and you can see this in all the energy and excitement, is that the data is really starting to come together in so many different ways that MRD testing provides incremental value.

我的意思是，我們認為我們現在還處於早期階段，我們認為報銷政策實施後，今年將會是一個非常好的年份。你知道，我們並沒有對未來幾年的情況進行預測，也沒有提供具體的數字，但你說得對，我們將全力以赴，並繼續通過一些銷售代表來加強他們的方法，以更細緻的方式真正地覆蓋市場，從而幫助他們加速推進他們的工作。你知道，在過去的幾個月裡，我們確實學會瞭如何做到這一點，所以它將繼續發展壯大。但在這個市場中，從高層層面來看，你可以從所有的活力和興奮中看到，數據正在以各種不同的方式匯聚在一起，MRD 檢測提供了增量價值。

And to patients, to doctors to patients, doctors, clinicians, the data is looking great across multiple vendors or multiple people that are providing things, and I think the market's acceleration is starting to pick up. I think you all are different analysts have, said that we're probably 5% penetrated somewhere around that. So you can imagine if we double, triple the market, and we can get a toe hold on that. I think it's a, I think we're in a real, we'll be in a really good position.

對於患者、醫生、臨床醫生來說，來自多個供應商或多個服務提供者的數據看起來都很棒，我認為市場正在加速發展。我認為你們的觀點都不一樣，分析師說我們目前的滲透率可能在 5% 左右。所以你可以想像一下，如果我們把市場規模擴大一倍、兩倍，我們就能站穩腳步。我認為，我認為我們現在處境非常好。

Great. Thank you.

偉大的。謝謝。

Our next question comes from [Sebu Nandi] with Guggenheim.

下一個問題來自古根漢美術館的[Sebu Nandi]。

Hey guys, this is Thomas in for Sebu. Thanks for taking our questions. Maybe a follow-up on the question earlier about the two large pharma customers and then just relating that to pipeline. I think those were around $5 million each. Is that roughly the size you'd expect for customer going forward or in the future do you expect that account size to increase alongside your scaling of the business? Any color on the pipeline would be helpful.

大家好，我是托馬斯，替塞布上場。謝謝您回答我們的問題。或許可以就先前提到的兩家大型製藥客戶的問題做個後續討論，然後將其與產品線連結起來。我記得每輛大概值500萬美元。您認為未來客戶的規模大致會是這樣嗎？或者，隨著業務規模的擴大，您預期未來客戶的帳戶規模也會增加嗎？管道上的任何顏色都會有所幫助。

Oh, I think, yeah, I think the, I mean, I think as you penetrate these accounts, there's more than $5 million of potential inside these larges inside these large customers, so we expect that number to that number to grow.

哦，我想，是的，我想，我的意思是，我認為隨著你深入這些帳戶，這些大客戶中蘊藏著超過 500 萬美元的潛在價值，所以我們預計這個數字會增長。

Capturing in a large biopharma with multiple oncology trials prospectively, being able to capture 100% of that share in a world where they're really using MRD, I think it will be worth more than that. So I think we're early stages in penetrating that, but that's a journey in and of itself too, right? You just don't go there overnight making progress with it.

考慮到大型生物製藥公司正在進行多項腫瘤試驗，並且能夠在真正使用 MRD 檢測的世界中佔據 100% 的市場份額，我認為它的價值將遠不止於此。所以我覺得我們還處於探索這個領域的早期階段，但這本身也是一段旅程，對吧？你不可能一夕之間就取得進展。

Okay, great. Thanks. And then maybe just to follow-up on within Pharma. A newer account versus those more mature accounts, what's the difference in kind of order growth rate you're seeing? Are you still seeing acceleration among those mature accounts and then maybe what's the typical run rate for some of those mature accounts?

好的，太好了。謝謝。然後或許可以跟進一下製藥業內部的情況。新帳戶與成熟帳戶相比，訂單成長率有何不同？您是否仍然看到這些成熟帳戶的成長速度加快？如果是，那麼這些成熟帳戶的典型成長速度是多少？

Pharma and [Biopharma]?

製藥和【生物製藥】？

Yeah, Biopharma MRT.

是的，生物製藥MRT。

Yeah, we, I mean, there's, most of our energy is focused on the top biopharma companies where they're spending large amounts of money on clinical trials that you can imagine that set of care that set of customers and that's where we're focused and so it's a penetration drill because we're in most of those places right now. Some of the smaller biopharma biotech companies are opportunities, but we're really probably focusing on on going deeper and winning more business and so. These customers and partly I think ultra sensitivity opens up more opportunities for them to be able to do more with MRD technology and so I think we're also expanding probably the market by by a result of what we're doing as we pioneer this this approach.

是的，我的意思是，我們的大部分精力都集中在頂尖的生物製藥公司身上，這些公司在臨床試驗上投入了大量資金，你可以想像，這些公司服務於哪些客戶群體，而這正是我們關注的重點，所以這是一次滲透演練，因為我們現在已經涉足了其中的大多數領域。一些規模較小的生物製藥生物技術公司是機會，但我們真正可能關注的是深入發展並贏得更多業務等等。我認為，這些客戶以及部分超高靈敏度為他們提供了更多利用 MRD 技術的機會，因此我認為，隨著我們率先採用這種方法，我們也正在擴大市場。

We're really optimistic about where biopharma is going to go as well. Over the last two quarters, the pipeline and funnel for MRD has grown rapidly. In addition, the orders that have come in for MRD projects have continued to grow. The challenges we've seen near term have been on the translational research side and as Chris mentioned in the prepared remarks, we have been seeing, some delays on the sample receipt side, which has been a headwind to the biopharma revenue, but, overall we're optimistic about where this is going.

我們對生物製藥產業的未來發展也非常樂觀。在過去的兩個季度裡，MRD 的銷售管道和銷售漏斗迅速成長。此外，MRD 項目的訂單量持續成長。近期我們面臨的挑戰主要集中在轉化研究方面，正如克里斯在準備好的發言稿中提到的那樣，我們在樣品接收方面出現了一些延誤，這對生物製藥收入造成了不利影響，但總的來說，我們對未來的發展方向持樂觀態度。

I mean, I will note that, we had two large customers on the Tara and Moderna that had declined this year. We expected obviously both of those Moderna because they, it ended there. It ended enrolling their Phase 3 melanoma trial, which really drove our numbers last year and then the era, we were winding that down this year and so when you subtract, you just, look at that the loss of that business and then where we end up this year, we're still going to grow this 40%. This year, I mean it's still really nice growth and the business is shifting and the mix is shifting, and that opens up a set of challenges. But there's a, that that's really healthy growth and that's been driven off the back of the progress that we're having with FRT. I would just, I just know one thing for folks listening, we really, when we hunkered down in this new world, we were really, focused on managing the cash burn and making sure we were really prudent and so, our cash. Usage guidance has not changed this year. We've really focused on making sure we were really smart with our spending and what we're investing this year in the midst of what's been a challenging year because of some of the biopharma slowdown and managing through it. So, we have been really focused on the financial discipline here of making, of hitting the cash burn number and being really prudent with investors with investors' money.

我的意思是，我要指出的是，我們今年在 Tara 和 Moderna 上的兩個大客戶數量有所下降。我們當然預料到了 Moderna 的這兩家，因為事情就此結束了。它結束了 3 期黑色素瘤試驗的招募工作，這在去年極大地推動了我們的業績，然後我們今年開始逐步結束這項試驗，所以當你扣除這部分損失時，你會發現，這部分業務的損失，以及我們今年的最終業績，我們仍然會實現 40% 的增長。今年，成長勢頭依然強勁，業務模式和產品組合也在不斷變化，這帶來了一系列挑戰。但確實存在著一種非常健康的成長，這種成長是由我們在 FRT 方面取得的進展所推動的。我只想告訴各位聽眾一件事，當我們在這個新世界裡蟄伏下來時，我們真的非常專注於控制現金消耗，確保我們非常謹慎，所以我們的現金。今年的使用指南沒有改變。今年由於生物製藥產業成長放緩，情況充滿挑戰，我們一直非常注重確保支出和投資的明智性，並努力應對這項挑戰。所以，我們一直非常注重財務紀律，努力控制現金消耗，並且謹慎對待投資人的資金。

Great. Thank you, guys, very much.

偉大的。非常感謝各位。

Our next question is from Mike Matson with Needham & Company.

我們的下一個問題來自 Needham & Company 的 Mike Matson。

Yeah, thanks for taking my question. So, just with regards to Nara, so there was a big decline this quarter. I think it was expected, but is there any revenue expected from them in the 4th quarter, or is it, are they completely out of your numbers beyond this quarter? And then, I assume if not, you're not expecting any next year either.

謝謝你回答我的問題。所以，就奈良而言，本季出現了大幅下滑。我認為這在意料之中，但是預計第四季會有他們的收入嗎？或者說，他們是否完全不在您的第四季之後的收入計劃之內？那麼，我猜如果沒有，你也不期待明年會有。

Oh, no, it's very small in the 4th quarter. It's pretty small in the second quarter, we really started to bleed down in Q1, Q2 with the idea that Q2 would be sunsetting, and then at the end of Q2, and then we've just been doing clean up or helping on some studies. That we had been, helping them with, because they probably want the same technology, right, or platform or whatever, so it's been, but it's been very small, so it's bleeding down and you see that in the numbers where almost all of our revenue this quarter was biopharma revenue. Right, and so which we made and most of that revenue is just a diversity of clients and so actually when you really look at the numbers, I mean we've come a long way of building a diverse set of biopharma customers and really what's now mostly a pharmaceutical based revenue. A base and of course that'll start to change as we get Medicare reimbursement, and we start to layer in the clinical and it starts to grow rapidly alongside that. But you know we've really transitioned the revenue profile a really, I think I think overall really positive way for the company and you're seeing that right now in those numbers, so the terra is pretty much out of it.

哦，不，第四季非常小。第二季規模很小，我們在第一季和第二季就開始逐漸減少，因為當時的想法是第二季會結束，然後在第二季末，我們只是做一些收尾工作或協助一些研究。我們一直在幫助他們，因為他們可能想要同樣的技術、平台或其他什麼，所以一直在幫助他們，但規模很小，所以正在逐漸減少，你可以從數據中看出這一點，我們本季度的收入幾乎全部來自生物製藥。沒錯，所以我們做到了，而且大部分收入都來自多元化的客戶群體，所以實際上當你真正查看這些數字時，我的意思是，我們在建立多元化的生物製藥客戶群方面取得了長足的進步，而現在的收入主要來自製藥行業。這只是個開始，當然，隨著我們獲得醫療保險報銷，情況會開始改變，我們會開始加入臨床內容，然後它就會隨之迅速增長。但你知道，我們已經真正地改變了收入結構，我認為這對公司來說總體上是一個非常積極的方向，你現在從這些數據中就能看到這一點，所以 Terra 基本上已經不在考慮範圍之內了。

Okay, got it. And then just trace the X trial, any expectation of when that will be published, and then where do things stand on colorectal with getting a dossier put together for that in terms of the data, trials, etc. You need there.

好的，明白了。然後追蹤 X 試驗的進展，了解預計何時發表結果，以及在結直腸癌方面，收集數據、試驗等資料的情況如何。你需要了解這些資訊。

Sure, Rich is going to jump in.

當然，里奇肯定會參與其中。

Yeah, so the X study to be published in the next quarter sometime, so that's going to be great to have that come out, a really strong study over 400 patients, non-small cell lung cancer, so really will be a great, summary of how strong the performance with next person is, in lung, non-small cell lung cancer.

是的，X 研究將在下一季發表，這真是太好了，這是一項針對 400 多名非小細胞肺癌患者的強有力的研究，因此它將很好地總結 Next Person 在肺癌（非小細胞肺癌）治療中的療效。

And in CRC, we're just starting the journey there. It'll be one of our things that we'll work on this next year, but the investigators still have to decide that that particular study, it's time to wind that down and submit that data for publication, and we are, we're.

而對 CRC 來說，我們才剛開始這段旅程。這將是我們明年要努力的方向之一，但研究人員仍需決定是否應該結束這項研究，並將數據提交發表，而我們正在努力。

We're not there yet, so, and when that happens, then that'll be submitted and obviously we can't submit for coverage until it's accepted, and so we're still on that, we're still, early in the journey on CRC.

我們還沒達到那個階段，所以，當那一步到來時，我們就會提交，顯然，在它被接受之前，我們不能提交報銷申請，所以我們還在進行中，我們仍然處於 CRC 征程的早期階段。

Yeah, okay, got it.

好的，明白了。

Our next question is from John Wilkin with Craig-Hallum Capital Group.

下一個問題來自 Craig-Hallum Capital Group 的 John Wilkin。

Hi guys. So I wanted to just press a little bit more on the molecular volume growth in the quarter. I know you guys had, you guided earlier in the year to expecting 30 to 40% sequential growth, and you kind of talk through some of the reasons that came in short of that, but, I mean, just given the stock reaction, I think there might be some concerns out there that with a couple of other players launching MRD tests in the market, there could be other factors driving that kind of below that target range and Given you had also given that before you had reimbursement, so maybe you could just drill down a little bit more on that and talk through anything that was impacting the volume growth.

嗨，大家好。所以我想再重點談談本季的分子體積成長情形。我知道你們年初曾預測季增30%到40%，也解釋過一些未能達到預期的原因。但是，考慮到股價的反應，我認為市場可能存在一些擔憂，因為其他幾家公司也在市場上推出MRD檢測，這可能會導致其他因素使成長低於目標範圍。而且，你們之前也提到過健保報銷的問題，所以或許你們可以更深入地探討一下，分析一下影響銷售成長的因素。

On the clinical side now, I mean, we're, I think we've said, and Tempest has said that we want to be really smart with where we are and we have not, we've certainly not seen any slowdown. The retention's been high, and we've continued to add some new clients, but not at a torrid rate as we've pulled back a bit, but the retention's been super high. And I think, nearly 30% quarter over quarter growth and what's traditionally a pretty flat quarter is actually really strong quarter. The numbers are starting to get bigger, quite frankly, too.

就臨床方面而言，我的意思是，我想我們已經說過，Tempest 也說過，我們希望在現有基礎上採取非常明智的策略，而且我們目前還沒有看到任何放緩的跡象。客戶留存率一直很高，我們也一直在增加一些新客戶，但成長速度並不快，因為我​​們稍微放緩了成長速度，但客戶留存率仍然非常高。我認為，環比成長近 30%，而通常情況下，這個季度業績會比較平淡，但實際上卻非常強勁。坦白說，這些數字也開始變得越來越大了。

Yeah, so we were thoughtful, so with revenue only $14.5 million in Q3, John.

是的，所以我們經過深思熟慮，第三季的收入只有 1450 萬美元，約翰。

We did a Pump the brakes a little bit on volume primarily because you know we have to balance margin dilution and cash usage as well. And then the other point that Chris mentioned earlier was in the 3rd quarter, typically you do have some seasonality, right? And the goals that we set out, over a year ago were 30 to 40%.

我們稍微控制了銷量，主要是因為我們也需要平衡利潤率稀釋和現金使用。還有一點，克里斯之前提到的是，第三季通常會有一些季節性因素，對吧？一年多前，我們設定的目標是 30% 到 40%。

Quarter over quarter growth and, like Chris had said previously, we've already achieved.

季度環比增長，正如克里斯之前所說，我們已經實現了這一目標。

The level that we had targeted to be at the end of the year a quarter early and so, we didn't see a need to go overboard and push forward more volume in the 3rd Quarter and then drive margins even lower, right? So you have to kind of appreciate what we were trying to do in terms of balancing cash burn and the margin dilution as well.

我們原定的目標水平是在今年年底提前一個季度達到，因此，我們認為沒有必要在第三季度過度擴張銷量，從而進一步降低利潤率，對吧？所以你應該能理解我們當時在平衡現金消耗和利潤率稀釋方面所做的努力。

That makes sense. Appreciate the clarification. And then, wondering if you could talk through just any, anything you've been hearing from the field through your conversations with Tempest and what their, what sort of feedback their sales team is getting. I know they haven't been talking too much about our MRD yet just in advance of reimbursement, but any early feedback you are getting, and talk about any like ordering patterns with the 700 ordering positions you're at now.

這很有道理。感謝您的解釋。然後，我想知道您是否可以談談您透過與 Tempest 的對話從第一線人員那裡聽到的任何消息，以及他們的銷售團隊收到的回饋類型。我知道在報銷之前，他們還沒有過多談論我們的 MRD，但是如果你得到了任何早期反饋，請談談你目前 700 個訂購職位的任何類似訂購模式。

Yeah, I mean, I think one of the One of the learnings is we were collectively we were really the first set of companies to really pioneer this notion of the one stop shop along with the ultra sensitive and combining that together to stitch it together and I think that's been a really compelling value proposition. I think physicians want to get the get all this together, in their case by the hereditary test, certainly the CGP. And in the MRD, and we, we've gotten really positive feedback about the approach that they've taken, and we've been the customers when they started we have largely stayed with us. It's great to have a test where 40% of the positive results are unique and differentiated and That that that allows us to underline the value that we're that we're delivering every day with these doctors. So the feedback has been super positive and we've been able to, keep the growth going and we really focused this last, a couple quarters we said really learning the logistics of the business and how to, and how to win more business within accounts because ultimately it's going to be depth of penetration it's going to make a difference within an account.

是的，我的意思是，我認為我們學到的經驗之一是，我們實際上是第一批真正開創「一站式服務」理念的公司，我們將超敏感技術結合起來，把兩者融合在一起，我認為這是一個非常有吸引力的價值主張。我認為醫生們希望把所有這些資訊匯總起來，就他們而言，是透過遺傳測試，當然是 CGP。在 MRD 中，我們收到了對他們所採取的方法的非常積極的回饋，而且我們從他們開始的時候就是他們的客戶，我們基本上一直和他們保持合作關係。這項測試中 40% 的陽性結果都是獨特且有差異化的，這非常棒，也讓我們能夠強調我們每天與這些醫生一起提供的價值。所以回饋非常積極，我們得以保持成長動能。在過去的幾個季度裡，我們真正專注於學習業務的運作方式以及如何在客戶中贏得更多業務，因為最終，滲透深度將對客戶產生影響。

Perfect, thanks a lot guys.

太好了，非常感謝！

Our next question is from Arthur He with H.C. Wainwright & Co.

下一個問題來自 H.C. Wainwright & Co. 的 Arthur He。

Hey, good afternoon, guys. This is Arar on for RK. So just a quick follow-up regarding the clinical test growth. Could you give us more color on the how this, growth be driven by, it's more from the increase in the physician numbers or new physician numbers or it's more from the test number per physician getting, increased to push the test number?

嘿，各位下午好。這裡是Arar為RK發來的。關於臨床試驗進展，我再簡單跟進。您能否詳細說明一下這種增長是如何驅動的，是更多地來自醫生數量的增加或新醫生數量的增加，還是更多地來自每位醫生檢測數量的增加以推動檢測數量的增長？

Yeah, I mean, we a little bit of both, but I mean we've been really focusing on not so much trying to grow top-line but getting more out of the accounts. So, if there's I think we've learned how to sell positions, and you know that's one way to quote manage the investment that we're spending we're spending is not focused on driving deeper and faster and quicker growth within the physician community but rather really focusing in on going deeper and so that that's been the crux of a lot of the growth is getting more from these accounts.

是的，我的意思是，我們兩者兼顧，但我們一直真正關注的不是如何提高營收，而是如何從現有客戶那裡獲得更多收益。所以，我認為我們已經學會瞭如何出售頭寸，你知道，這是一種管理投資的方式，我們投入的資金並不是專注於在醫生群體中推動更深入、更快速的增長，而是真正專注於深入挖掘，因此，很多增長的關鍵在於從這些賬戶中獲得更多收益。

All right, thanks for taking my question.

好的，謝謝你回答我的問題。

Ladies and gentlemen, with no further questions in the question queue, it brings us to the end of this event.

女士們、先生們，由於提問隊伍中已無其他問題，本次活動到此結束。

Goodbye.

再見。