Personalis Inc (PSNL) 2023 Q4 法說會逐字稿

Welcome to the Personalis fourth quarter 2023 earnings conference call. (Operator Instructions) Reminder conference is being recorded. It is now my pleasure to introduce your host, Caroline Corner of Investor Relations. Thank you.

歡迎參加 Personalis 2023 年第四季財報電話會議。（操作員指示）提醒會議正在錄製。現在我很高興向您介紹主持人，投資者關係部的卡洛琳‧科納 (Caroline Corner)。謝謝。

Thank you, operator, and welcome to Personalis Fourth Quarter and Full Year 2023 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President, Aaron Tachibana, Chief Financial and Chief Operating Officer; and Rich Chen, Chief Medical Officer and EVP R&D.

謝謝營運商，歡迎參加 Personalis 第四季和 2023 年全年財報電話會議。參加今天電話會議的包括執行長兼總裁 Chris Hall、財務長兼營運長 Aaron Tachibana；以及首席醫療官兼研發執行副總裁 Rich Chen。

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

本次電話會議中發表的所有與歷史事實無關的聲明均應被視為美國證券法含義內的前瞻性聲明。例如，有關我們今年財務業績的趨勢和預期以及長期現金跑道收入預期和報銷時間、黃金銷售和預訂訂單、產品服務、技術、臨床里程碑、報銷決策的結果和時間、預期的任何聲明我們現有和未來的合作活動、成本預期、我們的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 most recent filings with the SEC, including the risk factors described in our most recent filing. Personalis undertakes no obligation to update these statements except as required by applicable law.

這些陳述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。我們鼓勵您查看我們最近向 SEC 提交的文件，包括我們最近提交的文件中所述的風險因素。除適用法律要求外，Personalis 不承擔更新這些聲明的義務。

Our press release with the full year and fourth quarter 2020 results is available on the website, www.personalis.com under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. Our recording of today's call will be available on our website by 5 p.m. Pacific Time today. Now I would like to turn the call over to Chris for his comments on full year and fourth quarter business highlights.

我們關於 2020 年全年和第四季度業績的新聞稿可在網站 www.personalis.com 的「投資者」部分查看，其中包括有關我們財務業績的更多詳細資訊。我們的網站上還有我們最新的 SEC 文件，我們鼓勵您查看。今天的通話錄音將於下午 5 點在我們的網站上發布。今天太平洋時間。現在我想把電話轉給克里斯，請他對全年和第四季的業務亮點發表評論。

Thank you, Caroline, and good afternoon, everyone, and thank you for joining us. 2023 was a year of strong performance for Personalis as we build a culture of execution and winning. We focused on the MRD market, reduced our annual expenses by $35 million and extended our cash runway to two years delivered on all of our commitments to investors, investors and positioned our company for a pivotal 2024.

謝謝卡羅琳，大家下午好，謝謝您加入我們。 2023 年是 Personalis 表現強勁的一年，我們建立了一種執行力和獲勝的文化。我們專注於 MRD 市場，將年度開支減少了 3500 萬美元，並將我們的現金跑道延長至兩年，兌現了我們對投資者的所有承諾，並為我們公司的 2024 年做好了準備。

We ended the year with $73.5 million in revenue at 13% year-over-year growth. And our culture of execution yielded many important wins we received Medicare coverage for NeXT Dx, which is our high performance, comprehensive genomic profiling or CGP test. We launched an early access program for our ultra-sensitive MRD test. Next personal, we presented compelling early stage lung cancer, MRD data with our partners.

截至年底，我們的營收為 7,350 萬美元，年增 13%。我們的執行文化取得了許多重要的勝利，我們獲得了 NeXT Dx 的醫療保險承保，這是我們的高性能、全面的基因組分析或 CGP 測試。我們為超靈敏 MRD 測試啟動了早期訪問計劃。接下來，我們與合作夥伴一起展示了令人信服的早期肺癌 MRD 數據。

At tracer X, we entered collaborations with multiple leading cancer centers to develop robust clinical evidence. We entered partnerships with companies including Myriad, Tempus and Madonna, and we extended our agreement with Terra with momentum across our business. We're excited for what lies ahead. Taking a step back.

在 Tracer X，我們與多個領先的癌症中心合作，以開發強有力的臨床證據。我們與 Myriad、Tempus 和 Madonna 等公司建立了合作夥伴關係，並以整個業務的勢頭擴大了與 Terra 的協議。我們對未來感到興奮。退一步。

We're focused on achieving scale and our $100 million in 2025 plan where we intend to cross $100 million in annual revenue in 2025, and then we put in place a growth strategy with three engines to propel us there. First and most importantly, we are executing on our win and MRD. strategy CMRG market using liquid biopsy to find evidence of molecular residual disease or cancer recurrence is estimated to mature into a $20 billion opportunity. And we are establishing Personalis is a leading company in this space and clinical evidence is coming together to demonstrate that an ultra-sensitive test provides tremendous value to patients, doctors and partners, and that was Personalis in a position to grow rapidly.

我們專注於實現規模化和 2025 年 1 億美元計劃，我們計劃在 2025 年年收入突破 1 億美元，然後我們制定了由三個引擎推動我們實現這一目標的成長策略。首先也是最重要的是，我們正在執行我們的勝利和 MRD。策略 使用液體活檢來尋找分子殘留疾病或癌症復發證據的 CMRG 市場估計將成熟為 200 億美元的機會。我們正在將 Personalis 打造為該領域的領先公司，臨床證據不斷證明超靈敏測試為患者、醫生和合作夥伴提供了巨大價值，而這正是 Personalis 能夠快速發展的原因。

Second, we're leveraging our core immuno Idenix platform to support biopharma customers in their drug discovery efforts and personalized cancer vaccine companies and their efforts to establish a new generation of therapies. Our proprietary solutions create a unique molecular fingerprint of a patient's cancer, allowing for new insights and pushing the entire field forward.

其次，我們利用我們的核心免疫 Idenix 平台來支持生物製藥客戶的藥物發現工作和個人化癌症疫苗公司及其建立新一代療法的努力。我們的專有解決方案創建了患者癌症的獨特分子指紋，從而提供新的見解並推動整個領域向前發展。

Third, we are deepening and expanding our relationships with our enterprise customers such as new Terra and the VA MVP with our personnel's inside approach that allows customers to leverage our technology and ability to produce cost effective assays.

第三，我們正在深化並擴大與企業客戶（例如 new Terra 和 VA MVP）的關係，我們人員的內部方法使客戶能夠利用我們的技術和能力來進行具有成本效益的檢測。

I'll now walk you through a more tactical view of our 2024 strategy as we push into delivery on our $100 million in 2025 plan.

現在，隨著我們在 2025 年推動 1 億美元計畫的交付，我將帶您更全面地了解我們的 2024 年策略。

Before I'll turn it over to Aaron, who will detail our 2023 financial highlights and our guidance for this year 2024, starting with next person or first growth engine. I quickly remind you that our win and MRD. strategy has four pillars. First focus and launch our test in cancer types where an ultrasensitive liquid biopsy test can unlock significant value for patients, payers and partners.

在我交給 Aaron 之前，他將詳細介紹我們 2023 年的財務亮點以及我們對 2024 年的指導，從下一個人或第一個成長引擎開始。我很快提醒您，我們的勝利和 MRD。戰略有四個支柱。首先重點關注並啟動我們針對癌症類型的測試，其中超靈敏液體活檢測試可以為患者、付款人和合作夥伴釋放巨大價值。

Second to drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators. Third, to leverage our deep pharma relationships to accelerate adoption and power our revenue growth by using the next personal using X personal and clinical trials and forth to commercialize NeXT Personal with a partner-centric model delving into the first pillar, we've previously explained how we're developing evidence to support NeXT Personal clinical usage in early-stage lung cancer, breast cancer and IO therapy monitor.

其次，透過開發可靠的臨床證據並與全球頂級合作者合作來推動報銷。第三，為了利用我們深厚的製藥關係來加速採用並推動我們的收入成長，透過使用X 個人和臨床試驗以及以合作夥伴為中心的模型深入研究第一個支柱，將NeXT Personal 商業化，我們之前已經解釋過我們如何開發證據來支持 NeXT Personal 在早期肺癌、乳癌和 IO 治療監測中的臨床應用。

Our focus on these cancers is intentional as we believe we can win with our ultra-sensitive approach in each indication. We believe that detecting recurrence as early as possible can dramatically impact a patient's health and that a highly sensitive test can be used to deescalate patients from ineffective therapies, potentially saving payers, money and sparring patient therapies and procedures they may not. You might recall that we launched our NeXT Personal DXLDT. for MRD. in October 2023, and we are currently selectively launching that on direct Early Access Program or EAP.

我們對這些癌症的關注是有意的，因為我們相信我們可以透過對每種適應症的超敏感方法來獲勝。我們相信，儘早檢測復發可以極大地影響患者的健康，並且高度敏感的測試可用於使患者免受無效治療的影響，從而有可能節省付款人、金錢並避免患者可能無法接受的治療和手術。您可能還記得我們推出了 NeXT Personal DXLDT。對於MRD。 2023 年 10 月，我們目前正在選擇性地在直接搶先體驗計畫 (EAP) 上啟動該計畫。

We are the first ultra-sensitive test to market and the adoption of our tests has been rapid and indeed, it's exceeding our initial targets. We now have characterized and are monitoring more than 250 patients referred to us by only 10 doctors involved in the program. We've capped the number of MDs in our early access program. We have a waitlist of more than 150 doctors that have indicated they wanted to be included.

我們是第一個推向市場的超靈敏測試，我們的測試得到了迅速採用，事實上，它超出了我們最初的目標。我們現在已經對 250 多名患者進行了特徵分析和監測，這些患者是由參與該計畫的 10 名醫生轉介給我們的。我們在搶先體驗計劃中限制了 MD 的數量。我們有超過 150 名醫生的候補名單，他們表示希望加入。

Moving to our second pillar, I believe many of you saw the compelling early-stage lung cancer clinical MRI data presented by Professor Charles Swan and Dr. James Black with tracer next October. The TRACER study is greatly advancing the understanding of lung cancer and cancer biology. And the next and next personal is enabling an ultrasensitive specific detection of CTDNA. before and after surgery through treatment and during surveillance for recurrent cancer, which we believe will ultimately allow clinicians to make more informed decisions about patient care to put it in the simplest terms, the data show that our ultra sensitive approach can detect cancer up to 11 months performance.

轉向我們的第二個支柱，我相信你們中的許多人都看到了明年 10 月 Charles Swan 教授和 James Black 博士使用示踪劑提供的令人信服的早期肺癌臨床 MRI 數據。TRACER 研究大大增進了對肺癌和癌症生物學的理解。下一個和下一個個人正在實現 CTDNA 的超靈敏特異性檢測。在手術前後、治療期間以及復發性癌症監測期間，我們相信這最終將使臨床醫生能夠就患者護理做出更明智的決定。用最簡單的術語來說，數據表明，我們的超靈敏方法可以檢測高達11 的癌症月表現。

We are completing the testing of the full cohort for the TRACER study and expect our collaborators to submit in 2024 for publication, we expect that work once published to form the foundation of a Medicare submission for lung cancer and breast cancer. We completed processing samples from our collaboration with the Royal Marsden, one of the leading global institutions and breast. Our work here is focusing on patients with early-stage disease for several subtypes, including ER positive HER2 positive triple-negative breast cancer.

我們正在完成 TRACER 研究的完整隊列測試，並預計我們的合作者將於 2024 年提交發表，我們預計該工作一旦發表，將為肺癌和乳腺癌的醫療保險提交奠定基礎。我們與皇家馬斯登（全球領先的乳房研究機構之一）合作完成了樣品處理。我們在這裡的工作重點是患有多種亞型早期疾病的患者，包括 ER 陽性 HER2 陽性三陰性乳癌。

The Royal Marsden collaboration provides access to a well annotated set of samples with known clinical outcomes. We plan to use our work here to provide a clinical dataset to support Medicare coverage in breast. This data set is expected to be showcased in mid 2024. We are also working with the Dana-Farber Cancer Institute in breast cancer, which provides us with a robust set of HER two positive prospectively gathered samples and with the Korea Institute, which provides access to a study in triple negative breast cancer. These collaborations are extremely important because we have multiple cohorts that we can leverage to drive commercial success and underpin our reimbursement submission.

皇家馬斯登合作提供了一組具有已知臨床結果且註釋良好的樣本。我們計劃利用我們在這裡的工作提供臨床數據集來支持乳房的醫療保險覆蓋。該資料集預計將於 2024 年中期展示。我們也與Dana-Farber 癌症研究所合作研究乳癌，該研究所為我們提供了一組強大的HER 兩個陽性前瞻性收集樣本，並與韓國研究所合作，該研究所為我們提供了三陰性乳癌研究的機會。這些合作非常重要，因為我們可以利用多個群體來推動商業成功並支持我們的報銷提交。

Additionally, for breast cancer, our own perspective, clinical trial called these stronger is underway. We've made progress establishing committed sites and we've begun enrolling patients. Breast cancer is an important priority for us, and we continue to deepen our collaborations that expand our clinical evidence.

此外，對於乳癌，我們自己的觀點，稱為這些更強的臨床試驗正在進行中。我們在建立承諾站點方面取得了進展，並且已經開始招募患者。乳癌是我們的重要優先事項，我們將繼續深化合作，擴大我們的臨床證據。

Turning to IO therapy monitoring are key study as a pan cancer data set with the valve to Hebron Institute of Oncology or VHIO. design to demonstrate and leverage the efficacy of NeXT Personal CHIO. gives us access to a large well annotated bank of prospectively gathered samples that are the cornerstone of our efforts to achieve reimbursement coverage for PanCancer IO therapy monitoring. We've begun testing VHIO. patient samples and expect clinical data presented in the middle of 2024.

轉向 IO 治療監測是一項關鍵研究，作為希伯倫腫瘤研究所 (Hebron Institute of Oncology) 或 VHIO 的泛癌症數據集。旨在展示和利用 NeXT Personal CHIO 的功效。使我們能夠存取大量註釋明確的前瞻性收集樣本庫，這些樣本是我們努力實現 PanCancer IO 治療監測報銷範圍的基石。我們已經開始測試 VHIO。患者樣本並預計在 2024 年中期提供臨床數據。

This exciting collaboration joins existing work we have announced on melanoma I/O therapy with University Medical Center, Hamburg, Eppendorf, also known as KY. and R. Duke and UC San Diego relationships. These data sets will form the core of our Medicare submission for coverage for IO therapy. Monitor reimbursement coverage is accomplished with great products that demonstrate clinical utility and our relentless focus on execution to build and publish the data. Our team at Personalis is focused on delivering data to collaborators that spotlight the compelling performance of our approach and then submitting for reimbursement coverage for all three cancer types this year.

這項令人興奮的合作加入了我們與漢堡 Eppendorf 大學醫學中心（也稱為 KY）在黑色素瘤 I/O 治療方面的現有合作。以及 R. Duke 和加州大學聖地牙哥分校的關係。這些資料集將構成我們醫療保險提交的 IO 治療承保範圍的核心。監控報銷範圍是透過展示臨床實用性的優秀產品以及我們對建構和發布數據的執行的不懈關注來實現的。我們的 Personalis 團隊專注於向合作者提供數據，突出我們的方法的引人注目的性能，然後提交今年所有三種癌症類型的報銷範圍。

The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the use of ex personal clinical trials. We are engaged with most of the world's top biopharma customers and have received positive feedback on our platform. Customers want an ultrasensitive approach to ensure that only the most appropriate patients enter into a clinical trial. The promise of an ultrasensitive assay is a we believe patients testing negative are much less likely to recur.

我們 NeXT Personal 策略的第三個支柱是利用我們的生物製藥關係來推動前個人臨床試驗的使用。我們與大多數世界頂級生物製藥客戶合作，並在我們的平台上收到了正面的回饋。客戶希望採用超靈敏的方法來確保只有最適合的患者才能進入臨床試驗。超靈敏檢測的前景是我們相信檢測呈陰性的患者復發的可能性要小得多。

This would mean for our biopharma customers that these patients are less likely to benefit from a therapeutic intervention. The data that the tracer X team analyzed on lung cancer indicated that patients testing CTD. and a negative on our assay largely didn't recur and were still alive five years later. This holds out the promise that NeXT Personal could be an excellent approach to optimize biopharma trials. Indeed, here in the first quarter. We've already booked record new orders for NeXT Personal, and we believe it will be a driver of revenue moving forward, an important way for us to deepen the clinical utility of NeXT Personal.

對於我們的生物製藥客戶來說，這意味著這些患者不太可能從治療介入中受益。Tracer X 團隊分析的肺癌數據表明，患者接受了 CTD 測試。我們的檢測結果呈現陰性，基本上沒有再出現，五年後仍存活。這預示著 NeXT Personal 可能成為優化生物製藥試驗的絕佳方法。確實，在第一季。我們已經為 NeXT Personal 預訂了創紀錄的新訂單，我們相信這將成為營收成長的推動力，也是我們深化 NeXT Personal 臨床實用性的重要途徑。

Now move on to the fourth and final pillar commercializing NeXT Personal using a partner-centric model. On our last call, we mentioned that we are seeking partnerships that help us amplify our message to the Park Place, allowing us to market and sell our test in a capital-efficient manner.

現在轉向第四個也是最後一個支柱，使用以合作夥伴為中心的模型將 NeXT Personal 商業化。在上次電話會議中，我們提到我們正在尋求合作夥伴，以幫助我們向 Park Place 傳達訊息，使我們能夠以資本高效的方式行銷和銷售我們的測試。

In December, we announced our key partnership with Tempus to commercialize NeXT Personal Dx and clinics with oncologists. We are thrilled that campus selected us as their MRD. tumor informed choice to offer to their customers under the agreement, we will leverage services sales channel, which consists of more than 200 sales professionals calling on oncologists to co-commercialize NeXT Personal, the Axon Accelerate Growth.

12 月，我們宣布與 Tempus 建立重要合作夥伴關係，將 NeXT Personal Dx 和腫瘤科醫生診所商業化。我們很高興校園選擇我們作為他們的 MRD。根據協議，我們將利用由 200 多名銷售專業人士組成的服務銷售管道，呼籲腫瘤學家共同將 NeXT Personal（Axon Accelerate Growth）商業化。

Personalis will process samples in our lab to obtain reimbursement and invoice health insurance payers and patients enter the arrangement all pain campus, fair market value for the commercial services they provide to us overall, the deal is worth approximately $30 million for Personalis, should all the milestone payments be triggered and if campus fully exercises there. Most importantly, though, it allows us to ramp up our commercial efforts quickly with minimal cash investments. We will work through 2024 to expand our early access program to include Tempus, and we'll learn how to work together as partners integrating our business systems and refining our message to colleges. This is an exciting relationship that paves the way to achieving commercial traction in a capital-efficient manner.

Personalis 將在我們的實驗室處理樣本，以獲得報銷並向健康保險付款人和患者開具發票，讓他們進入所有疼痛園區，他們為我們提供的商業服務的公平市場價值總體而言，這筆交易對Personalis 來說價值約3000 萬美元，如果所有如果校園在那裡充分行使，就會觸發里程碑付款。但最重要的是，它使我們能夠以最少的現金投資快速加大商業力度。我們將在 2024 年之前擴大我們的搶先體驗計劃，將 Tempus 納入其中，我們將學習如何作為合作夥伴共同努力，整合我們的業務系統並完善我們向大學傳達的訊息。這是一種令人興奮的關係，為以資本高效的方式實現商業吸引力鋪平了道路。

Now while we made strides with our first growth engine, our win and MRD. strategy to establish NeXT Personal was a leading MRD test. We've also made progress with our second growth engine, leveraging our immuno IV NeXT platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies and enterprise customers as they develop a ramp up volume for tissue and forest products we previously told you about our partnership with modernity, personal cancer therapies were modernity utilizing our platform and our mRNA cancer program. We have several other partners that work in this space as well modernity and its partner. Merck are enrolling patients in clinical trials, and we expect our collaboration with Novartis to be a driver of revenue for us at 24 and 2025.

現在，當我們憑藉第一個成長引擎、我們的勝利和 MRD 取得長足進步時。建立 NeXT Personal 的策略是一項領先的 MRD 測試。我們在第二個成長引擎方面也取得了進展，利用我們的免疫IV NeXT 平台加深與生物製藥客戶的關係，這些客戶使用該產品開拓新療法，以及企業客戶，因為他們開發了我們之前告訴過的組織和林業產品的產量增長關於我們與現代性的合作關係，個人癌症治療是現代性利用我們的平台和我們的 mRNA 癌症計劃。我們還有其他幾個在這個領域工作的合作夥伴以及現代性及其合作夥伴。默克正在招募患者參加臨床試驗，我們預計與諾華的合作將在 24 日和 2025 年成為我們收入的推動力。

In November, we disclosed the Myriad is expanding its pharma service offerings by introducing our BIGX. platform to pharmaceutical partners who use Myriad's cancer tests. This is another exciting opportunity to continue to grow our biopharma customer base. Myriad is a pioneer in the industry and we're excited to be collaborating with them.

11 月，我們透露 Myriad 正在透過推出 BIGX 來擴展其製藥服務產品。為使用 Myriad 癌症檢測的製藥合作夥伴提供平台。這是繼續擴大我們的生物製藥客戶群的另一個令人興奮的機會。Myriad 是該行業的先驅，我們很高興與他們合作。

Last month, we disclosed that we also partnered with clear node health. Clear note has an epic genomic platform that we believe is gaining traction with biopharma customers by allowing those partners to detect cancer earlier monitor disease progression and understand mechanisms, mechanisms of resistance with the aim of identifying promising drug targets and biomarkers in this relationship, Personalis is Biopharma sales team will bring clearing those products to its cut to our customers, which provide another growth vehicle relationships like the Myriad and clear, no deals are examples how we expect our partner-centric approach to drive our revenue going forward.

上個月，我們透露我們也與 Clear Node Health 合作。Clear note 擁有一個史詩般的基因組平台，我們相信該平台正在吸引生物製藥客戶，讓這些合作夥伴能夠更早地檢測癌症、監測疾病進展並了解機制、抗藥性機制，以識別這種關係中有前途的藥物標靶和生物標誌物，Personalis 是生物製藥銷售團隊將把這些產品清理給我們的客戶，這提供了另一種增長工具關係，如Myriad 和明確的、無交易的例子，我們期望我們以合作夥伴為中心的方法來推動我們的收入成長。

We are laser focused on adding value to biopharma customers with a comprehensive suite of products and services and accelerating our growth rate. You will know when Aaron walk through guidance for the year ahead, we expect our biopharma segment to grow in 2024 by more than 20%. This is a reflection of the progress we are making certain segments.

我們專注於透過全面的產品和服務為生物製藥客戶增加價值，並加快我們的成長率。當 Aaron 介紹未來一年的指導時，您就會知道，我們預計我們的生物製藥部門將在 2024 年成長 20% 以上。這反映了我們在某些​​領域的進展。

The third engine of our growth strategy is probably not a personnel side approach as we service enterprise customers and these relationships, partners adopt our platforms, the technology to power their solution to provide new insights to their customers. We have two larger relationships where this is the case versus new tariffs. We've partnered with Terra for a few years and they've leveraged our sequencing platform to analyze the exosome as a part of their Signatera product.

我們成長策略的第三個引擎可能不是人員方面的方法，因為我們為企業客戶和這些關係提供服務，合作夥伴採用我們的平台和技術來支援他們的解決方案，為他們的客戶提供新的見解。我們有兩個更大的關係，就是這種情況與新關稅的關係。我們與 Terra 合作了幾年，他們利用我們的定序平台來分析外泌體，作為其 Signatera 產品的一部分。

At the end of the year, we extended our agreement with material through the end of 2024. We work this year. With new Teradata evolve our platforms, we can reduce our price to them on growing our margins to those ends, we expect our revenue to decline this year from the Terra would expect our margins to improve and are optimistic we put in place the foundation to continue that relationship over time.

年底，我們將材料協議延長至 2024 年底。我們今年工作。隨著新的Teradata 發展我們的平台，我們可以降低對他們的價格，以提高我們的利潤，以達到這些目的，我們預計今年來自Terra 的收入會下降，我們預計我們的利潤率會提高，並且樂觀地認為我們為繼續發展奠定了基礎隨著時間的推移這種關係。

Our second key enterprise relationship is with the VA the VA utilizes our whole-genome sequencing capabilities to power the Million Veterans Program and national research program, looking at how teams lifestyle, military experience and exposure affects health and wellness and veterans we have helped power this program with the VA for years, and we're excited to continue the work in 2020 for both of these relationships are examples of how our platforms drive value for partners are focused on expanding our efforts with additional partners.

我們的第二個關鍵企業關係是與退伍軍人管理局，退伍軍人管理局利用我們的全基因組測序能力來支持百萬退伍軍人計劃和國家研究計劃，研究團隊的生活方式、軍事經驗和接觸如何影響健康和保健以及我們幫助推動這項計劃的退伍軍人我們與VA 合作多年，我們很高興能夠在2020 年繼續開展這項工作，因為這兩種關係都是我們的平台如何為合作夥伴帶來價值的例子，我們致力於與更多合作夥伴一起擴大我們的努力。

This year, we made significant progress across multiple fronts, and we appreciate our collaborators, partners and investors being part of the journey to establish an ultra-sensitive test at the forefront of the emerging markets. I want to especially thank my colleagues and our team at Personalis for their extraordinary efforts in 2023 to navigate through a challenging climate as we reduced head count, grew our revenue, launched new products, chief coverage showcase truly transform formative clinical data. 2024 is an exciting year, and we look forward to updating you on our progress towards our $100 million in 2025 initiative and our wind and MRG strategy with that I will now turn it over to Aaron to review our financial results.

今年，我們在多個方面取得了重大進展，我們感謝我們的合作者、合作夥伴和投資者參與在新興市場前沿建立超靈敏測試的過程。我要特別感謝我的同事和我們在Personalis 的團隊在2023 年做出的非凡努力，以應對充滿挑戰的環境，我們減少了員工數量，增加了收入，推出了新產品，主要報道展示了真正轉變的形成性臨床數據。 2024 年是令人興奮的一年，我們期待向您通報 2025 年 1 億美元計劃以及我們的風能和 MRG 戰略的最新進展，我現在將其交給 Aaron 來審查我們的財務業績。

Thank you, Chris. Our fourth quarter and full-year 2023 financial results and milestone achievements demonstrate our ability to execute crisply. And importantly, we continue to meet our financial commitments. I will be providing details of fourth quarter and full-year 2023 financial results and guidance for the first quarter and full-year of 2024.

謝謝你，克里斯。我們的 2023 年第四季和全年財務表現以及里程碑式的成就證明了我們敏捷執行的能力。重要的是，我們繼續履行我們的財務承諾。我將提供 2023 年第四季和全年財務業績的詳細資訊以及 2024 年第一季和全年的指導。

Total company revenue for the fourth quarter of 2023 was $19.7 million and increased 18% compared with $16.7 million for the same period of the prior year. The increase in revenue was due to higher volume from biopharma customers and the VA MVP. For the full year of 2023, total company revenue was $73.5 million, an increased 13% compared to $65 million for the full year of 2022. The full year revenue increase was due to higher volume biopharma customers, the Terra and the VA MVP.

2023年第四季公司總營收為1,970萬美元，較上年同期的1,670萬美元成長18%。收入的成長歸因於生物製藥客戶和 VA MVP 的銷售增加。2023 年全年，公司總營收為 7,350 萬美元，較 2022 年全年的 6,500 萬美元成長 13%。全年營收成長得益於生物製藥客戶 Terra 和 VA MVP 的銷售增加。

Gross margin was 26.5% for the fourth quarter compared to 13.8% for the same period of the prior year. A year-over-year increase of 12.7 percentage points was primarily due to operating leverage from 18% higher revenue volume and also an increase in work performed for product development and clinical evidence generation that is classified as R&D.

第四季毛利率為 26.5%，去年同期毛利率為 13.8%。年比成長 12.7 個百分點，主要是由於收入成長 18% 帶來的營運槓桿，以及歸類為研發的產品開發和臨床證據生成工作的增加。

For the full year of 2023, gross margin was 24.8% compared with 20.5% for the full year 2022. The 4.3 percentage points of margin expansion was primarily due to favorable operating leverage from the 13% increase in revenue volume. Operating expenses were $29.2 million in the fourth quarter and included a one-time expense of $4 million for employee severance costs from the reduction in workforce compared with $34.4 million for the same period of the prior year. Excluding the employee severance costs, operating expenses were $25.1 million, an decreased $9.3 million from the same period last year.

2023年全年毛利率為24.8%，而2022年全年毛利率為20.5%。利潤率成長 4.3 個百分點，主要是由於營收成長 13% 帶來的有利營運槓桿。第四季營運費用為 2,920 萬美元，其中包括因裁員而產生的一次性員工遣散費 400 萬美元，而去年同期為 3,440 萬美元。不含員工遣散費，營運費用為2,510萬美元，比去年同期減少930萬美元。

R&d expense was $13.6 million in the fourth quarter compared with $16.6 million for the same period last year. And SG&A expense was $11.5 million compared with $17.8 million for the same period last year. For the full year of 2023, operating expenses were $128.1 million and included severance and lease impairment costs of $13.6 million compared with $128.9 million for the full year of 2022. In 2023, we made significant progress in reducing our expense base by approximately $35 million annually.

第四季研發費用為 1,360 萬美元，去年同期為 1,660 萬美元。SG&A 費用為 1,150 萬美元，去年同期為 1,780 萬美元。2023 年全年營運費用為 1.281 億美元，其中包括 1,360 萬美元的遣散費和租賃減損成本，而 2022 年全年營運費用為 1.289 億美元。2023 年，我們在每年減少約 3,500 萬美元的支出方面取得了重大進展。

Net loss for the fourth quarter was $26.6 million compared to $31.1 million for the same period of the prior year. The fourth quarter net loss included $4 million for employee severance costs and also, an additional $4 million of non-cash expense related to the fair value accounting of the outstanding warrants issued to Tempus. This non-standard expense was a result of the increase in fair value of the warrants at December 31, 2023, compared with the fair value -- the fair market value when the warrants were issued.

第四季淨虧損為 2,660 萬美元，上年同期淨虧損為 3,110 萬美元。第四季淨虧損包括 400 萬美元的員工遣散費，以及與向 Tempus 發行的未償認股權證的公允價值會計相關的額外 400 萬美元的非現金費用。此非標準費用是由於 2023 年 12 月 31 日認股權證的公允價值較公允價值（認股權證發行時的公平市價）增加所致。

The net loss per share for the fourth quarter was $0.54 and a weighted average basic and diluted share count was $49.6 million compared to $0.67 and a weighted average basic and diluted share count of $46.3 million for the same period of the prior year. For the full year of 2023, net loss was $108.3 million compared with $113.3 million for the full year of 2022.

第四季每股淨虧損為 0.54 美元，加權平均基本和稀釋股票數為 4,960 萬美元，而去年同期為 0.67 美元，加權平均基本和稀釋股票數為 4,630 萬美元。2023 年全年淨虧損為 1.083 億美元，而 2022 年全年淨虧損為 1.133 億美元。

For full year net loss included $8.1 million of employee severance costs, $5.6 million of a lease impairment write-down for the Menlo Park facility previously vacated, and a $4 million expense related to the fair value accounting of the outstanding warrants issue to FX. Net loss per share for the full year of 2023 was $2.25, and the weighted average basic and diluted share count was $48.2 million compared with $2.48 and a weighted average basic and diluted share count of $45.7 million for the full year of 2022.

全年淨虧損包括810 萬美元的員工遣散費、先前騰空的門洛帕克工廠的租賃減損減記560 萬美元，以及與向FX 發行的未償還認股權證的公允價值會計相關的400 萬美元費用。2023 年全年每股淨虧損為 2.25 美元，加權平均基本和稀釋股票數為 4,820 萬美元，而 2022 年全年每股淨虧損為 2.48 美元，加權平均基本和稀釋股票數為 4,570 萬美元。

Now onto the balance sheet. We finished the fourth quarter with a strong balance sheet with cash and short-term investments of $114.2 million. During the quarter, we used $6.5 million. and for the full year of 2023, we used $53.5 million of cash, primarily to fund operations. In the fourth quarter, we received $6 million from Tempus related to the first two milestone payments. And we estimate the remaining $6 million of payments to be received equally in 2024 and 2025. We have approximately two years of cash on the balance sheet, which is expected to last through the first quarter of 2026.

現在進入資產負債表。第四季末，我們的資產負債表強勁，現金和短期投資達 1.142 億美元。本季度，我們使用了 650 萬美元。 2023 年全年，我們使用了 5,350 萬美元現金，主要用於為營運提供資金。第四季度，我們從 Tempus 收到了與前兩次里程碑付款相關的 600 萬美元。我們預計剩餘的 600 萬美元付款將在 2024 年和 2025 年平均收到。我們的資產負債表上有大約兩年的現金，預計將持續到 2026 年第一季。

Now I'd like to turn to guidance for the first quarter of 2024, we expect total company revenue in the range of $18 million to $19 million, revenue from pharma tests, enterprise sales and other customers in the range of $16 million to 17 million and revenue from population sequencing of approximately $2 million. And for the full year of 2024, we expect total company revenue in the range of $73 million to $75 million with oncology revenue from pharma tests, enterprise sales and other customers in the range of $65 million to $67 million in population sequencing revenue approximately $8 million.

現在我想談談 2024 年第一季的指導，我們預計公司總收入在 1800 萬美元到 1900 萬美元之間，來自藥物測試、企業銷售和其他客戶的收入在 1600 萬美元到 1700 萬美元之間群體定序收入約200 萬美元。2024 年全年，我們預計公司總收入在7,300 萬美元至7,500 萬美元之間，其中來自藥物測試、企業銷售和其他客戶的腫瘤學收入在6,500 萬美元至6,700 萬美元之間，群體定序收入約為800 萬美元。

Our full year revenue guidance of $73 million to $75 million includes an estimated revenue decline of approximately 25% from the Terra which reduces our total revenue by 10% to 12%. In late 2023, we amended our volume supply agreement with them. This amendment extends the minimum quarterly volume out through the end of 2024 compared with two one in the prior agreement. In addition, we have modified selling prices to the Terra Industries in this amendment, along with the ability to convert to a cost optimized product so that the amended terms are beneficial for both companies.

我們的全年收入指引為 7,300 萬至 7,500 萬美元，其中 Terra 預計收入下降約 25%，這使我們的總收入減少 10% 至 12%。2023 年末，我們修改了與他們的批量供應協議。與先前協議中的兩次相比，此次修訂將最低季度產量延長至 2024 年底。此外，我們在本次修訂中修改了對 Terra Industries 的銷售價格，並能夠轉換為成本優化的產品，以便修訂後的條款對兩家公司都有利。

We expect revenue growth from biopharma customers to offset the decline from the tariffs in addition, we expect net loss of approximately $80 million, which is $28 million lower than the loss of $108 million in 2023. And this estimate does not include any income or expense related to the outstanding warrants issue to Tempus. Cash usage is expected to be approximately $62 million and includes employee severance payments of approximately $3 million from the Q4 23 reduction in headcount. We look forward to updating you on our progress during the next conference call in a few months.

我們預計生物製藥客戶的收入成長將抵消關稅帶來的下降，此外，我們預計淨虧損約為 8,000 萬美元，比 2023 年 1.08 億美元的虧損減少了 2,800 萬美元。且此估計不包括與向 Tempus 發行的未償還認股權證相關的任何收入或費用。現金使用量預計約為 6,200 萬美元，其中包括 23 年第四季裁員帶來的約 300 萬美元的員工遣散費。我們期待在幾個月後的下一次電話會議上向您通報我們的最新進展。

And with, that I will turn the call back over to the operator to begin the Q&A session.

然後，我會將電話轉回接線生開始問答環節。

(Operator Instructions)

（操作員說明）

Tejas Savant.

特哈斯·薩凡特。

Hi, this is [Madison Patricia] come for Tejas. Thanks for taking the question. And I think I just had two for you one starting out on within biopharma. I was just wondering, could you comment on some other peers are seeing if you're seeing any headwinds from the tightening of customers' budgeting or they're seeing stabilization on that front? And as we look at 2024, do you have any headwinds baked into the guide? Or do you expect see it's a recovery in the biopharma spend?

嗨，我是[麥迪遜·帕特里夏]，為光輝而來。感謝您提出問題。我想我剛剛為您準備了兩個，其中一個是從生物製藥行業開始的。我只是想知道，您能否評論一下其他一些同行是否看到了客戶預算收緊帶來的任何阻力，或者他們看到了這方面的穩定性？當我們展望 2024 年時，您的指南中是否存在任何不利因素？或者您預計生物製藥支出會復甦嗎？

Yes, hi, Madison. This is Aaron. Thanks for the question. In terms of the biopharma landscape, so in the over the past couple of years, there had been some slowdowns and trials and things of that nature. We're not seeing a lot of that sitting in front of us today. Our funnel is building. And as Chris went through the prepared remarks, we talked about our wind and MRP. strategy. So we're seeing a lot of good take-up for our NeXT Personal Products in biopharma. And in addition, as part of the biopharma revenue. We also have our PCB business with Madonna ramping up their Phase three clinical trial. They've been going through enrollment, and we're starting to see those patient samples started certainly coming to us now.

是的，嗨，麥迪遜。這是亞倫。謝謝你的提問。就生物製藥領域而言，過去幾年出現了一些放緩和試驗等類似性質的事情。今天，我們並沒有看到太多這樣的事。我們的漏斗正在建立。當克里斯完成準備好的演講時，我們討論了我們的風和 MRP。戰略。因此，我們看到生物製藥領域對我們的 NeXT 個人產品有許多良好的採用。此外，作為生物製藥收入的一部分。我們還有 PCB 業務，麥當娜正在加強他們的第三階段臨床試驗。他們一直在進行登記，我們開始看到這些患者樣本現在肯定開始來到我們這裡。

Okay. Got it. That's good to hear from. And then maybe just one more. I know you've talked about MacDon as being an important contributor to your top line in 2024 and 2025. And I was wondering if you could comment on how much it's embedded into the 2024 guide and how you see that ramping throughout the year and into 2025, sorry, 20 years.

好的。知道了。很高興收到您的來信。然後也許還有一個。我知道您曾說過 MacDon 是您 2024 年和 2025 年營收的重要貢獻者。我想知道您是否可以評論一下它在 2024 年指南中的嵌入程度，以及您如何看待這一趨勢在全年和 2025 年（抱歉，20 年）中的增長。

But we haven't said publicly what those specific numbers are from internal. So we'd probably try to stay away from that. But what we can say, what we have said in the past to set our biopharma and total biopharma plus PCV, we'll more than offset any of the decline. We're going to see from them the Terra business in 2024 French. So the guide we have for our total oncology business in 2024 is $65 million to $67 million, which is up a tiny bit from 2023.

但我們還沒有公開透露這些具體數字是來自內部的。所以我們可能會盡量避免這種情況。但我們可以說的是，我們過去所說的設定我們的生物製藥和總生物製藥加上 PCV，我們將足以抵消任何下降。我們將在 2024 年法國看到他們的 Terra 業務。因此，我們對 2024 年腫瘤學業務總量的指導是 6,500 萬至 6,700 萬美元，比 2023 年略有上升。

Got it. Thanks.

知道了。謝謝。

Thank you.

謝謝。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

This is [jini] Mark. Thanks for taking the question. And I apologize, I might have missed and some jumping around on calls here, but and could you just walk me through and how we should be thinking about the next per small launch with Tempus. And I guess what steps do you need to take before the launch and have fully marketed? And then I just kind of want to circle back to and if we should still be expecting the next tracer X readout and maybe in the middle of this year?

這是[jini]馬克。感謝您提出問題。我很抱歉，我可能錯過了一些電話，但是你能告訴我一下，我們應該如何考慮與 Tempus 進行下一次小型發布。我想在推出並全面上市之前您需要採取哪些步驟？然後我想回想一下，我們是否仍然應該期待下一個示踪劑 X 讀數，也許是在今年年中？

Thanks.

謝謝。

Yes, there are some things we will start with Tempus arm with Tempus, we and we've launched the test as early access programs as commercially available. I talked on the call over now, we baseline and created the <unk> unique molecular fingerprint for more than 250 patients and are now monitoring those patients with our liquid biopsy approach. And so that's super exciting. The uptake has been phenomenal and I've been I've been CEO, worked on many launches of products, and that's my the ones that I've been really taken aback by the strong demand that is out there is for an ultrasensitive approach. So we're super excited with Tempus.

是的，有些事情我們將從 Tempus 手臂開始，我們已經將測試作為商業可用的早期訪問程序啟動。我現在在電話會議上談到，我們為 250 多名患者建立了基線並創建了獨特的分子指紋，現在正在使用我們的液體活檢方法監測這些患者。這真是太令人興奮了。這種採用是驚人的，我一直擔任首席執行官，參與過許多產品的發布，這就是我對超敏感方法的強烈需求感到驚訝的產品。所以我們對 Tempus 感到非常興奮。

We'll be working with them through the entire year two with a field starting with a few reps, and they're just growing as the year goes on and our goal this year because we're not getting reimbursed for the test this year. So, you know, we're we'll be running at a relatively low volume situation, and we've been pretty clear about that until we get reimbursement. So the goal, as we go through the year is to, first of all learned how to work together. Secondly, integrate systems and make sure that we can we can not we can take samples from them appropriately, get them back results to deliver to their customers, et cetera.

我們將在整個第二年與他們合作，從幾個代表開始，他們只是隨著時間的推移和我們今年的目標而成長，因為我們今年的測試沒有得到報銷。所以，你知道，我們將在相對較低的產量情況下運行，在獲得報銷之前我們對此非常清楚。因此，我們這一年的目標是，首先學會如何一起工作。其次，整合系統並確保我們可以從他們那裡適當地取樣，讓他們返回結果以交付給他們的客戶，等等。

And then thirdly, to up to make sure we get messaging, right, et cetera, about how we talk about the testing to the community and at the right points. And so we've started that journey and we're working together. And we feel like now it's the time that we've worked with them as all the other lines that we feel like it's up. It's a great partnership but it's and it's built for the long term.

第三，確保我們得到正確的訊息，等等，關於我們如何在正確的時間點向社區談論測試。所以我們已經開始了這段旅程並且我們正在共同努力。我們覺得現在是我們與他們合作的時候了，就像我們認為其他所有產品線都已經完成一樣。這是一個很好的合作夥伴關係，但它是為了長期而建立的。

So we're super excited about where we are, and we're off to a great start. So that's and you'll see that that gave us confidence in talking about our $100 million in 2025 plan, which we're excited about on the tracer X data. I've got Rich in the room as Manny can sort of walk you through kind of how to think about that this year.

因此，我們對我們所處的位置感到非常興奮，並且我們有了一個良好的開始。因此，您會看到，這讓我們有信心談論 2025 年 1 億美元的計劃，我們對示踪劑 X 數據感到興奮。里奇（Rich）也在場，曼尼（Manny）可以引導您了解今年如何思考這個問題。

Is that data second, some large and now we work to make it public? Yes, the tracer ex expansion is on track. We're actively working on it, and we expect that that data should find its way to publication sometime this year.

這些數據是否是第二個，有些大，現在我們正在努力將其公開？是的，Tracer Ex 擴充包已步入正軌。我們正在積極開展工作，預計這些數據應該會在今年某個時候發布。

It is perfectly fine. Yes, yes. How should we think about reimbursement for NeXT Dx, but how are you thinking about the impact of the test in 2024?

完全沒問題。是的是的。我們應該如何考慮 NeXT Dx 的報銷，但您如何看待 2024 年測試的影響？

Yes. So if we achieve reimbursement, if you remember, I think what we've talked about, I mean, I know is that we if we use the reimbursement process for the test to establish relationships with payers who really are our job, our goal with moving forward with the test and bring it to market. So we were excited that we've started the dialogue with Palmetto and Goldex and how they now know who we are and can manage through the first tests. And I think that helps derisk NeXT Personal and for investors as we go through the year, we'll keep working on enlarging the number of payers to reimburse the test.

是的。因此，如果我們實現報銷，如果你還記得的話，我想我們已經討論過，我的意思是，我知道我們如果使用報銷流程進行測試，與付款人建立關係，他們確實是我們的工作，我們的目標繼續進行測試並將其推向市場。因此，我們很高興能夠開始與 Palmetto 和 Goldex 進行對話，了解他們現在如何了解我們並能夠通過第一次測試。我認為這有助於降低 NeXT Personal 的風險，對於投資者來說，在這一年中，我們將繼續努力擴大支付測試費用的付款人數。

So we'll be engaging with some of the big payers to trade up at large the number of payers. And again, it's a way for them to see the quality of product that we have with NeXT Dx, the quality organization and our systems and our processes so that when we come to next with them next personal we're a known entity of Medicare reimbursement was in the $3,200 range. And I and we had a I mean, should we did we disclose guidance?

因此，我們將與一些大型付款人合作，以增加付款人的數量。再說一遍，這是他們了解我們 NeXT Dx 的產品品質、品質組織、我們的系統和流程的一種方式，這樣當我們下次與他們接觸時，我們就是一個已知的醫療保險報銷實體是在3,200美元範圍內。我和我們有一個我的意思是，我們應該揭露指導嗎？

So our guidance for the oncology revenue is $65 million to 67 million. So inside of that number, but in a couple of million.

因此，我們對腫瘤學收入的指導是 6,500 萬至 6,700 萬美元。所以在這個數字之內，但在幾百萬之內。

Thanks for taking the question give us some.

感謝您提出問題，請給我們一些建議。

Thanks.

謝謝。

Daniel Samarco, TD Catlin.

丹尼爾·薩馬科，TD·卡特林。

Hey, Chris and Aaron. I am on Dan Brennan, thanks for taking the questions. So the first one in the reduction in force press release, you noted that you plan to vote clinical evidence across 10 different clinical studies. Could you just go into a little bit about how much R&D dollars you expect to invest in order to publish evidence and MRG?

嘿，克里斯和亞倫。我是丹布倫南，感謝您提出問題。因此，在減少強制力新聞稿中的第一篇文章中，您指出您計劃對 10 項不同臨床研究的臨床證據進行投票。您能否簡單介紹一下您預計將投入多少研發資金來發布證據和 MRG？

Yes. I mean, it's one of the reasons why we spend a lot of money on R&D is that we have invested heavily in this test. We think it's a significant opportunity of the 10 studies that you did. You mention there's tracer ex collaboration on running those samples and getting that submitted. We're well on track, and most of that work has already been done is in the rearview mirror at the P & L. We've in the lung cancer and breast cancer. We've working with SAP Royal Marsden. We're working with Saab Dana-Farber.

是的。我的意思是，我們在研發上花費大量資金的原因之一是我們在這項測試上投入了大量資金。我們認為這是您所做的 10 項研究中的一個重要機會。您提到在運行這些樣本並提交樣本方面存在追蹤器前協作。我們已經步入正軌，大部分工作已經在損益表的後視鏡中完成。我們已經完成了肺癌和乳癌的治療。我們與 SAP Royal Marsden 合作。我們正在與薩博·丹納法伯 (Saab Dana-Farber) 合作。

We're working with Accuray Institute. A chunk of those samples have already been run and you'll start to see that data come out in mid 2024. We have a prospective clinical trial would be struck would be stronger on collaboration. And we've we've got our first sites are enrolling our first set of patients, but we're probably still early days there in terms of the spending. But we think it's really important to have a have a prospective clinical trial there to establish the evidence and the clinical utility of the product to triple-negative breast cancer. And we're really excited about that indication because the opportunity to deescalate patients really is really exciting with an ultrasensitive approach.

我們正在與 Accuray Institute 合作。其中大部分範例已經運行，您將在 2024 年中期開始看到資料出來。我們有一個前瞻性的臨床試驗，合作會更加牢固。我們已經有了第一個站點，正在招募第一批患者，但就支出而言，我們可能還處於早期階段。但我們認為在那裡進行前瞻性臨床試驗以確定該產品對三陰性乳癌的證據和臨床效用非常重要。我們對這項適應症感到非常興奮，因為透過超靈敏的方法降低患者病情的機會確實令人興奮。

And IO therapy we have run most of the samples for DHIO., and you should start to see that data in 2024 and we bob and weave and we run many of the samples with our debt-to-cap now 10 a.m. and UK collaborations and then University of San Diego collaboration use onboard. So I don't know that we have a fixed percentage, but we've we've significantly we've spent a good chunk of the dollars that we need on those 10 studies.

IO 療法，我們已經運行了 DHIO 的大部分樣本。你應該在 2024 年開始看到這些數據，我們進行了調整，現在上午 10 點我們的債務上限和英國合作運行了許多樣本，然後與聖地亞哥大學合作在船上使用。所以我不知道我們有一個固定的百分比，但我們已經在這 10 項研究上花費了我們所需的很大一部分資金。

But I think as you know, in this space, you know, I mean, we're not done with just the 10. We think that can give us the good cornerstone to drive the right kinds of of submissions that will get us Medicare coverage because we think these data sets are strong and robust and comprehensive, but will be deepening the work in these three indications as we go forward, and it's a journey to two. It's a journey to build the evidence to show the clinical utility that's ultimately going to make a product like this standard of care.

但我認為，如你所知，在這個領域，你知道，我的意思是，我們不僅完成了 10 個任務。我們認為這可以為我們提供良好的基石來推動正確類型的提交，從而使我們獲得醫療保險覆蓋，因為我們認為這些數據集強大、穩健且全面，但隨著我們的前進，我們將深化這三個適應症的工作，這是兩個人的旅程。這是一個建立證據以展示臨床效用的旅程，最終將製造出像這種護理標準這樣的產品。

Great. Thanks, Chris. Just digging a little deeper into gross margins for the guide, food quality, as you mentioned it earlier. But would you mind going through a little bit of your assumptions for 24 and then possibly how they develop into 25?

偉大的。謝謝，克里斯。正如您之前提到的，只是更深入地研究指南的毛利率、食品品質。但您介意回顧一下您對 24 的假設嗎？然後它們可能如何發展為 25？

Sure. So in terms of gross margin, that's embedded in our guide. So we're assuming somewhere between, yes, somewhere around 25% plus or minus a point here and there for the full year. And then in terms of 2025, gross margins will increase, it will accrete. We haven't guided for '25 yet. So I'll I'd be hesitant to give you a specific number, but we should be in the low 30s in 2025, especially if we can get to this $100 million number that we're targeting, right? Because we're not going to be adding a lot of fixed costs. Most of that footprint for the lab operation has been invested in, we will need to add variable costs as volume grows. But for the most part, we're going to leverage fixed cost footprint.

當然。因此，就毛利率而言，這已包含在我們的指南中。因此，我們假設全年的成長率介於 25% 左右，上下加減一個點。然後到 2025 年，毛利率將會增加，將會增加。我們還沒有為'25做指導。所以我會猶豫是否給你一個具體的數字，但到 2025 年我們應該會在 30 左右，特別是如果我們能夠達到我們目標的 1 億美元數字，對嗎？因為我們不會增加大量固定成本。實驗室運營的大部分佔地面積已經投入，隨著數量的增長，我們將需要增加可變成本。但在大多數情況下，我們將利用固定成本足跡。

And thank you, guys, and thanks once again.

謝謝你們，夥伴們，再次感謝。

(Operator Instructions)

（操作員說明）

Mike Matson, Needham.

麥克馬森，李約瑟。

Hey, guys. This is Joseph on for Mike. Maybe just touching on that 2025 on revenue number, I guess maybe what are the the main assumptions in getting to that number? I guess more broadly, you know, do you need VA MVP revenue to remain stable, increase on? Do you expect a lot of this to be driven by by biopharma, mainly is the MVP upside just given the uncertainty around future task orders?

大家好。這是麥克的約瑟夫。也許只是談到 2025 年的收入數字，我想也許達到這個數字的主要假設是什麼？我想更廣泛地說，你知道，你是否需要 VA MVP 收入來保持穩定、增加？您是否預計這很大程度上是由生物製藥推動的，主要是考慮到未來任務訂單的不確定性，MVP 的上漲空間？

Yes. No, I mean, I think we so when we walk through the three drivers on the right in the heart of that is our win and MRG strategy. We are sitting here in 24 were well along the way in evidence development across key indications, how and we intend to submit for Medicare reimbursement across these three large indications this year, and we're on pace to do that. And we expect that to yield efforts and significant revenue because we're also growing the commercial traction with our partner Tempus. So as that starts to come together, we expect the revenue for our NeXT Personal and the clinical market to really start to grow and get traction. And that's a big driver of leads.

是的。不，我的意思是，我認為當我們走過右邊的三名車手時，我們的核心是勝利和 MRG 策略。我們在 24 年坐在這裡，在關鍵適應症的證據開發、如何以及我們打算今年針對這三大適應症提交醫療保險報銷方面進展順利，我們正在努力做到這一點。我們預計這將帶來成果並帶來可觀的收入，因為我們也與合作夥伴 Tempus 一起增強了商業吸引力。因此，隨著這些開始結合起來，我們預計 NeXT Personal 和臨床市場的收入將真正開始成長並受到關注。這是潛在客戶的重要推手。

And secondarily, we're seeing a lot of interest and and an excitement among the biopharma customers. But with ex personal, and that's starting to move the needle in terms of our growth rate. And you see that embedded in the guide with the we put traction in 2024 and the growth rate starting to pick up on. And that's that's that's just gone up. And we expect that to pick up steam as we come through the year and come into 25. That'll be a big year. We do have we have a 5-year sort of renewable set of agreements with the VA for the Million Veterans Program. But we don't we don't expect that now would be nice if that grew and there's certainly the possibility because there's a lot of untapped opportunity there that they have not sequence yet. And so it's possible that that would pick up steam. We have not assumed in any way that that's going to be a driver of us getting there. We've assumed that that will be pretty stable, to be honest.

其次，我們看到生物製藥客戶表現出極大的興趣和興奮。但對於前個人來說，這開始改變我們的成長率。您會看到指南中嵌入了「我們將在 2024 年加大力度，並且成長率開始加快」。就是這樣，剛剛上漲。我們預計，隨著今年進入 25 週年，這一趨勢將會加速。那將是重要的一年。我們確實與退伍軍人管理局就百萬退伍軍人計劃簽訂了一套為期五年的可續約協議。但我們不認為現在會很好，如果它成長的話，而且肯定有這種可能性，因為那裡有很多尚未開發的機會，他們還沒有排序。所以這可能會加速。我們並沒有以任何方式假設這將成為我們實現這一目標的驅動力。老實說，我們假設這將非常穩定。

Okay.

好的。

Yes. Thank you very much. That's super clear.

是的。非常感謝。說的超清楚啊

And then I guess just to understand the Tempus relationship a little bit more clearly. And in terms of like samples, cancer type samples, are you guys going at this as kind of agnostic to cancer type? Or is this a little bit more targeted towards the submissions you expect to do in 2024? And I know you guys said you're kind of just like feeling it out and I'm learning how to work together integrate systems.

然後我想只是為了更清楚地理解 Tempus 關係。就類似樣本、癌症類型樣本而言，你們是否認為這是對癌症類型的不可知論？或者這更有針對性地針對您預計在 2024 年提交的內容？我知道你們說你們只是想感受一下，我正在學習如何一起工作整合系統。

No, but we can be clear, right. We're focused on our own commercial energy and traction.And that with now we're focused on breast cancer were focused on I-O therapy monitoring, and we're focused on lung cancer. And as part of the agreement, they have exclusivity on those three, those three areas. And that's that's what we're focused on now, you know, and so that's the messaging that's the type of doctor that we call on. And that's that's what we're focusing on. We're seeing good chunk of our samples there.

不，但我們可以明確，對吧。我們專注於我們自己的商業能量和牽引力。現在我們專注於乳癌、I-O 治療監測，我們專注於肺癌。作為協議的一部分，他們在這三個領域擁有排他性。這就是我們現在關注的重點，你知道，這就是我們所呼籲的醫生類型。這就是我們關注的重點。我們在那裡看到了大量的樣本。

Now I'd be kidding, if I said everything within those three indications because if there are we get other stuff coming through the system. And we've got to manage that the best we can. But we're staying laser focused on these indications. And we'll and we'll as we go through the snow through the next several, several months and few years.

現在，如果我說出這三個跡像中的所有內容，那我就是在開玩笑，因為如果有的話，我們會透過系統得到其他東西。我們必須盡力做到這一點。但我們仍然高度關注這些跡象。在接下來的幾個月、幾個月甚至幾年裡，我們會、我們會在雪中度過。

Remember that, you know, the strategy here was to focus on the indications where we thought we could gain significant traction with an ultrasensitive approach at really tremendous value by finding cancer earlier, allowing us to escalate patients to therapies a quicker that actually could yield big results. And secondarily, because if you're flying blind, you do therapies and you do a invasive procedures that a patient may not get benefit from. But because you don't know who does it doesn't then you do it. So we have the opportunity to escalate patients, and that's especially true in breast cancer. So that's where we're focused and Dom and building and building.

請記住，您知道，這裡的策略是專注於我們認為可以透過超靈敏方法獲得顯著牽引力的跡象，透過更早發現癌症，從而真正獲得巨大的價值，使我們能夠更快地將患者升級到實際上可以產生巨大收益的治療方法。結果。其次，因為如果你盲目飛行，你會進行治療，並且進行侵入性手術，患者可能無法從中受益。但因為你不知道是誰做的，所以你就不會做。因此，我們有機會升級患者的治療範圍，對於乳癌尤其如此。這就是我們關注的重點，Dom 不斷建造。

And we think that from an investor standpoint that covers a good chunk of the market to be quite frank on.

坦白說，我們認為從投資者的角度來看，這涵蓋了市場的很大一部分。

I mean, it's not like these are esoteric parts of the MRT market where a good chunk of the patients are. And there's there's several hundred thousand patients here that are on I-O therapy and that are being monitored. And that breast cancer is the biggest one of the biggest cancers and lung cancer is one of the biggest cancers. And so those three together, those three indications together, we think cover a good significant portion of the USD20 billion expected market. And we feel like we're I think we're positioned to do well with this approach and in a cost-effective manner rather than building evidence across every single clinical indication simultaneously.

我的意思是，這些並不是 MRT 市場的深奧部分，其中有很大一部分患者。這裡有數十萬名患者正在接受 I-O 治療並受到監測。乳癌是最大的癌症之一，肺癌是最大的癌症之一。因此，我們認為這三個指標加在一起，涵蓋了 200 億美元的預期市場的很大一部分。我們覺得我們能夠以一種具有成本效益的方式善用這種方法，而不是同時在每個臨床適應症上建立證據。

Got you and makes sense. We'll Thanks for taking our questions. Much appreciated.

明白你並且有道理。我們將感謝您提出我們的問題。非常感激。

Thanks, Joe.

謝謝，喬。

Thank you, ladies and gentlemen.This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

謝謝女士們、先生們。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與，祝您有美好的一天。

Thanks.

謝謝。