Personalis Inc (PSNL) 2024 Q1 法說會逐字稿

Good day and welcome to the Personalis First Quarter 2024 earnings conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Mr. Aaron Tachibana. Please go ahead.

美好的一天，歡迎參加 Personalis 2024 年第一季財報電話會議。所有參與者將處於僅聽模式。如果您需要協助，請按星號鍵和零向會議專家發出訊號。今天的演講結束後，將有機會提問。（操作員說明）請注意此事件正在被記錄。現在我想將會議交給 Aaron Tachibana 先生。請繼續。

Thank you, operator. Welcome to Personalis First Quarter 2024 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President and I am and then touch upon our Chief Financial and Chief Operating Officer, and Rich Chan, Chief Medical Officer and EVP of R&D.

謝謝你，接線生。歡迎參加 Personalis 2024 年第一季財報電話會議。參加今天電話會議的有執行長兼總裁 Chris Hall，我是財務長兼營運官，也是首席醫療官兼研發執行副總裁 Rich Chan。

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 the U.S. securities laws. For example, in statements regarding trends and expectations for our financial performance this year and longer term cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, 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，在有關我們今年財務業績和長期現金跑道的趨勢和預期、收入預期和時間表、報銷目標、訂單規模和預訂、產品、服務、技術、臨床里程碑、報銷結果和時間表的聲明中決策、對我們現有和未來合作活動的期望、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 filings. Personalis undertakes no obligation to update these statements except as required by applicable law, our press release with our first quarter 2024 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 our latest SEC filings, which we encourage you to review. The 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 and first quarter business highlights.

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。Personalis 不承擔更新這些報表的義務，除非適用法律要求，我們的2024 年第一季業績新聞稿可在我們的網站www.personalis.com 的「投資者」部分查看，並包含有關我們財務業績的其他詳細資訊。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 點在我們的網站上提供。今天太平洋時間。現在我想把電話轉給克里斯，聽聽他的評論和第一季的業務亮點。

Thank you and good afternoon, everyone, and thank you for joining us. I'm very proud of our team at Personalis as we continue to fight cancer with our novel technologies. For those of you joining one of our calls for the first time, welcome. Personalis is one of the leaders in the fast-growing MRD testing market. MRD. stands for minimal residual disease with our first-of-its-kind ultrasensitive MRD test were able to spot cancer when it's only one fragment of tumor DNA circulating and 1 million DNA fragments of the plot. Our technologies are used by many of the world's top biopharma companies to improve clinical trial results find new ways to personalize treatment and power, a new generation of more effective therapies.

謝謝大家，下午好，謝謝您加入我們。我為我們的 Personalis 團隊感到非常自豪，因為我們繼續利用新技術對抗癌症。對於第一次加入我們通話的人，歡迎。Personalis 是快速成長的 MRD 檢測市場的領導者之一。MRD。代表微小殘留疾病，我們首創的超靈敏 MRD 測試能夠在只有循環腫瘤 DNA 片段和 100 萬個 DNA 片段的情況下發現癌症。我們的技術被許多世界頂尖生物製藥公司用來改善臨床試驗結果，找到個人化治療和動力的新方法，新一代更有效的療法。

Last quarter, we laid out a strategy to drive Personalis to $100 million in revenue in 2025. This aspirational milestone with three underlining growth engine is our Lodestar as we are accelerating Personalis into a higher growth mode. In the first quarter, we achieved revenue of $19.5 million, exceeding the upper end of our guidance of $18 million to $19 million.

上個季度，我們制定了一項策略，力爭在 2025 年將 Personalis 的營收推向 1 億美元。這個具有三個重要成長引擎的雄心勃勃的里程碑是我們的北極星，因為我們正在加速 Personalis 進入更高的成長模式。第一季度，我們實現了 1950 萬美元的收入，超出了 1800 萬至 1900 萬美元的指導上限。

Our biopharma business grew 55% compared to the first quarter of 2023, driven by strong demand for our core immunoassay platform to support the individualized neoantigen therapy market as well as increasing demand for our MRD. product mix personal. With this increased demand, we have the confidence to increase our full year revenue guidance to $76 million to $78 million from $73 million to $75 million.

與2023 年第一季相比，我們的生物製藥業務成長了55%，這得益於對我們的核心免疫分析平台的強勁需求，以支持個體化新抗原治療市場以及對我們的MRD 需求的不斷增長。產品組合個性化。隨著需求的增加，我們有信心將全年收入指引從 7,300 萬美元至 7,500 萬美元提高至 7,600 萬美元至 7,800 萬美元。

I'll now review progress this quarter on the three growth engines driving us towards our $100 million in 2025 goal and our progress on each in the first growth engine is the most important is we focus on turning Personalis into a clinical diagnostic powerhouse. In order to do that, we are executing on our win and MRD. strategy for the emerging market involves using liquid biopsy to find evidence of minimal residual disease or cancer recurrence and subsequently monitoring therapy effectiveness. It's estimated that this market will mature into a $20 billion opportunity over the coming years. And we are establishing Personalis is a leader in this space. Our win and MRD. strategy has four pillars, first to focus and launch our test in cancer types where an ultrasensitive liquid biopsy tests and unlock significant value for patients, payers and partners. Second, to drive reimbursement by developing robust clinical evidence of partnering with top global collaborators.

現在，我將回顧本季推動我們實現2025 年1 億美元目標的三個成長引擎的進展情況，其中第一個成長引擎中每個成長引擎的進展最重要的是我們專注於將Personalis 轉變為臨床診斷強國。為了做到這一點，我們正在執行我們的勝利和 MRD。新興市場的策略包括使用液體活檢來尋找微小殘留疾病或癌症復發的證據，並隨後監測治療效果。據估計，這個市場在未來幾年將成熟為價值 200 億美元的機會。我們正在建立 Personalis 成為該領域的領導者。我們的勝利和 MRD。該策略有四個支柱，首先關注並啟動我們針對癌症類型的測試，其中超靈敏的液體活檢測試並為患者、付款人和合作夥伴釋放重大價值。其次，透過與全球頂尖合作者合作開發強有力的臨床證據來推動報銷。

Third, leverage our deep relationships to accelerate adoption by biopharma partners and power our revenue growth by the use of NeXT Personal and clinical trials, and lastly to commercialize next partners, our NeXT Personal with a partner-centric model development. In the first pillar, we've previously explained how we're developing evidence to support next personals clinical usage and reimbursement in early-stage lung cancer, breast cancer and immunotherapy monitoring. We believe our ultra-sensitive technology allows us to see cancer earlier, which may provide the information to deescalate patients from unnecessary and necessary therapies and procedures potentially sparing patients from toxicity and saving healthcare dollars. Just as importantly, we believe we can identify and get recurrent patients to treatment earlier with potentially better outcomes.

第三，利用我們深厚的關係來加速生物製藥合作夥伴的採用，並透過使用NeXT Personal 和臨床試驗來推動我們的收入成長，最後透過以合作夥伴為中心的模型開發將下一個合作夥伴（我們的NeXT Personal）商業化。在第一個支柱中，我們之前已經解釋過我們如何發展證據來支持早期肺癌、乳癌和免疫療法監測中的下一代臨床使用和報銷。我們相信，我們的超靈敏技術使我們能夠更早發現癌症，這可能會提供信息，幫助患者減少不必要和必要的治療和程序，從而使患者免受毒性影響並節省醫療費用。同樣重要的是，我們相信我們可以識別復發患者並使其儘早接受治療，從而可能獲得更好的結果。

Our focus on these indications is intentional, and our data has demonstrated that NeXT Personal can win in these markets to elaborate a bit on our approach for early-stage lung cancer and breast cancer should variable DNA into the blood, which are difficult to detect without an ultrasensitive approach. Early Detection is critical in these indications for patients on IO therapy we believe the potential decision to switch treatment requires the insights from monitoring that are provided by our ultra-sensitive test.

我們對這些適應症的關注是有意的，我們的數據表明NeXT Personal 可以在這些市場中獲勝，以詳細說明我們治療早期肺癌和乳腺癌的方法，如果血液中DNA 發生變化，這是很難檢測到的超靈敏的方法。對於接受 IO 治療的患者來說，早期檢測對於這些適應症至關重要，我們認為轉換治療的潛在決定需要我們的超靈敏測試提供的監測見解。

Now you may recall that last October we launched our MRD test NeXT Personal. And today we are enrolling physicians in an Early Access Program or EAP. We are the first ultra sensitive MRD test to commercially enter the market. And with that, and with that launch, we now have two laboratory developed tests or LDTs on the market, the other being our Medicare reimburse test NeXT Dx, which is used by physicians to put a patient on targeted therapy. The adoption of these tests has been rapid and is exceeding our initial target. We delivered 338 clinical tests in the first quarter, a solid uptick from the 126 results delivered in the fourth quarter of last year. We're pleased with this traction as the number of physicians that were ordering in Q1 remain fixed at 10 through the quarter.

現在您可能還記得，去年 10 月我們推出了 MRD 測試 NeXT Personal。今天，我們正在招募醫生參加早期訪問計劃（EAP）。我們是第一個進入商業市場的超靈敏 MRD 測試。隨著這一點以及此次發布，我們現在在市場上有兩種實驗室開發的測試或 LDT，另一個是我們的醫療保險報銷測試 NeXT Dx，醫生用它來讓患者接受標靶治療。這些測試的採用速度很快，並且超出了我們最初的目標。我們在第一季提供了 338 項臨床測試，比去年第四季提供的 126 項結果大幅增加。我們對這種勢頭感到滿意，因為第一季訂購的醫生數量在整個季度都保持在 10 名。

There are two key metrics that I wanted to talk about a dive into. First, all 10 of our early access positions are ordering and uptake has been strong across the entire cohort.

我想深入探討兩個關鍵指標。首先，我們所有 10 個搶先體驗職位都已訂購，整個隊列的採用率都很高。

The second metric involves the actionability of our NeXT Personal MRD test for the clinic. If you remember, we report circulating tumor DNA in the blood down to one part per million, which means if there's just one fragment of tumor DNA circulating tumor DNA fragments in the blood, we expect to see and quantify it. This is a leap forward for the field. The extra sensitivity we report on with our NeXT Personal assay, which are values between 1 and 100 parts per million mask a region that has previously been hard to see consistently, we call that region the ultrasensitive MRD. range until next personal clinicians cannot return routinely detect cancer recurrence at that level.

第二個指標涉及我們的 NeXT 個人 MRD 測試對診所的可操作性。如果你還記得的話，我們報告血液中的循環腫瘤 DNA 降至百萬分之一，這意味著如果血液中只有一個循環腫瘤 DNA 片段，我們期望能夠看到並量化它。這是該領域的飛躍。我們透過 NeXT Personal 檢測報告的額外靈敏度（數值在百萬分之 1 到 100 之間）掩蓋了以前很難一致看到的區域，我們將該區域稱為超靈敏 MRD。範圍，直到下一個個人臨床醫生無法返回該水平常規檢測癌症復發。

And today they can about 40% of the CTDNA positive samples thus far in our clinical testing have been in this ultrasensitive range. That's a significant jump in the performance of MRTD. testing and means that physicians can see cancer recurrence earlier, have more discrimination and monitoring therapy and have more confidence that CTDNA. patients that are negative are likely cancer free. Indeed, we've had many dose relay from our channel early access doctors that the ultrasensitive range is allowing them to see cancer earlier with their patients and intervene to get them the management they need. We believe it is equal ultrasensitive range that allows the doctor to see cancer sooner and seen it sooner is the cornerstone of our wind and MRD. strategy.

今天，我們臨床測試中迄今約 40% 的 CTDNA 陽性樣本都處於這個超敏感範圍內。這是機讀旅行證件效能的顯著提升。檢測並意味著醫生可以更早發現癌症復發，有更多的區分和監測治療，並且比 CTDNA 更有信心。陰性的患者可能沒有癌症。事實上，我們已經從我們的管道早期訪問醫生那裡得到了許多劑量中繼，超靈敏範圍使他們能夠更早地看到患者的癌症，並進行幹預，為他們提供所需的管理。我們相信同樣的超靈敏範圍可以讓醫生更快看到癌症，更快看到它是我們風和MRD的基石。戰略。

Now moving to the second pillar. We're focused on building and publishing clinical evidence to gain reimbursement and are working with many of the top thought leaders in the world. In previous calls, we've talked about the importance of our work with Royal Marsden in breast cancer and BHIL. immunotherapy monitoring both of these collaborators and provided access to studies that are broad and comprehensive. In the case of Royal Marsden, one of the leading global institutions in breast cancer, we're focusing on patients with early-stage disease for several subtypes, including ER positive HER2 positive and triple negative breast cancer for VHIO., the work is pan cancer across many cancer types and stages.

現在轉向第二個支柱。我們專注於建立和發布臨床證據以獲得報銷，並與世界上許多頂級思想領袖合作。在先前的電話會議中，我們討論了與皇家馬斯登在乳癌和 BHIL 領域合作的重要性。免疫療法對這兩位合作者進行監測，並提供了廣泛而全面的研究的機會。以皇家馬斯登（全球領先的乳癌機構之一）為例，我們將重點放在多種亞型的早期疾病患者，包括 ER 陽性、HER2 陽性和 VHIO 三陰性乳癌。階段。

These studies are anchor studies and that they will be the backbone of our efforts to gain Medicare reimbursement for Royal Marsden for early-stage breast cancer and VHIO. for immunotherapy monitoring. We're excited that at the upcoming ASCO. conference to work with both of these collaborators will be featured as oral oral podium presentation. We also have three other studies featured at ASCO. one with Dana-Farber on Her two positive patients, another with Duke for immunotherapy monitoring for gastric patients.

這些研究是錨定研究，它們將成為我們為皇家馬斯登早期乳癌和 VHIO 獲得醫療保險報銷的努力的支柱。用於免疫治療監測。我們對即將舉行的 ASCO 會議感到非常興奮。與這兩位合作者合作的會議將以口頭口頭講台演示的形式進行。我們也在 ASCO 上發表了其他三項研究。其中一項是與丹娜—法伯癌症研究所（Dana-Farber）合作，對兩名陽性患者進行監測；另一項是與杜克大學（Duke）合作，對胃病患者進行免疫治療監測。

And lastly, one in colorectal cancer patients. Having this breadth of data should underscore our commitment at Personalis to developing rich data to support the use of NeXT Personal in the clinic and to gain reimbursement quickly at the AACR conference in April, some compelling data was presented our collaborators from the UK. You gave an oral podium presentation on late-stage melanoma patients where they use NeXT Personal to monitor and detect immunotherapy response, highlighting the importance of detection of CTDNA. and the ultrasensitive range.

最後，一項針對大腸直腸癌患者的研究。擁有如此廣泛的數據應該強調我們在Personalis 的承諾，即開發豐富的數據以支持NeXT Personal 在診所中的使用，並在4 月份的AACR 會議上快速獲得報銷，我們來自英國的合作者提供了一些令人信服的數據。您對晚期黑色素瘤患者進行了口頭講台演講，他們使用 NeXT Personal 來監測和檢測免疫療法反應，強調了 CTDNA 檢測的重要性。和超靈敏範圍。

In addition, our work in collaboration with AstraZeneca on their matrix study was presented. The Matrix abstract show NeXT Personal achieved very strong sensitivity and specificity on blinded test samples provided by AZ down to the lowest levels at two parts per million subsequently, we were selected as a partner by AstraZeneca for MRD testing in their upcoming trials. We've also presented data from collaborators with a personalized cancer vaccine company and our analytical validation data for NeXT Personal that was recently published was also it was also at the ACR conference.

此外，也介紹了我們與阿斯特捷利康在基質研究方面的合作工作。Matrix 摘要顯示NeXT Personal 對AZ 提供的盲測樣本實現了非常強的靈敏度和特異性，降至百萬分之二的最低水平，隨後我們被阿斯特捷利康選為合作夥伴，在其即將進行的試驗中進行MRD 測試。我們還提供了來自個人化癌症疫苗公司合作者的數據，以及最近在 ACR 會議上發布的 NeXT Personal 分析驗證數據。

The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the use of excess personnel in clinical trials. We're engaged with most of the world's top of biopharma companies and have continued to generate excitement around our NeXT Personal test. Most recently from discussions at ACR, customers want and need an ultrasensitive approach to ensure that the most appropriate patients enter into a clinical trial.

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在臨床試驗中使用多餘的人員。我們與世界上大多數頂級生物製藥公司都有合作，而我們的 NeXT Personal 測試繼續引起人們的興奮。最近在 ACR 的討論中，客戶希望並且需要一種超靈敏的方法來確保最合適的患者進入臨床試驗。

For example, we believe that our ultrasensitive assay means that patients tested negative are much, much less likely to have a recurrence. Our biopharma company customers can then expect that these patients are less likely to benefit from a therapeutic intervention holding out the promise that NeXT Personal can be an excellent approach to optimize bar at biopharma trials. Indeed, here in the first quarter, we booked a record new orders for next person product helped to drive our strong Q1 financial performance, and we believe it will be a driver of revenue moving forward, an important way for us to deepen the clinical utility of X personnel.

例如，我們相信我們的超靈敏檢測意味著檢測呈陰性的患者復發的可能性要小得多。我們的生物製藥公司客戶可以預期，這些患者不太可能從治療幹預中受益，這表明 NeXT Personal 可以成為優化生物製藥試驗中酒吧的絕佳方法。事實上，在第一季度，我們為下一代產品預訂了創紀錄的新訂單，這有助於推動我們強勁的第一季度財務業績，我們相信這將成為未來收入的驅動力，是我們深化臨床效用的重要方式X 人員。

Now I'll move on to the fourth and final pillar commercializing X personnel using a partner-centric model. In December, we announced our key partnership with Tempus to commercialize NeXT Personal Dx.

現在我將繼續討論第四個也是最後一個支柱，即使用以合作夥伴為中心的模型將 X 人員商業化。12 月，我們宣布與 Tempus 建立重要合作關係，將 NeXT Personal Dx 商業化。

Next personal in the clinic with oncologists to quickly review, we expect to leverage Tempus up to up to offices up to approximately 200 person sales channel to co-commercialize NeXT Personal and accelerate growth. Personalis will be responsible for processing samples in our lab, obtaining reimbursement and invoicing health insurance payers and patients under the arrangement while paying Tempus fair market value for the commercial services they provide to us.

接下來，我們將在診所與腫瘤學家進行快速審查，我們預計將利用 Tempus 最多辦公室、最多約 200 人的銷售管道來共同商業化 NeXT Personal 並加速成長。Personalis 將負責在我們的實驗室處理樣品、獲得報銷並向健康保險付款人和患者開具發票，同時向 Tempus 支付他們向我們提供的商業服務的公平市場價值。

Overall, the deal is worth approximately $30 million for Personalis, should all the milestone payments triggered. And if Tempus fully exercises their warrants. We expect this to allow us to ramp up commercial efforts quickly with minimal additional cash investments. We plan to launch with Tempus this quarter by expanding our early access program to include some of campuses clients. The goal is to learn how to work together as partners, integrating our business systems for funding our message to oncologists. So we're set to drive accelerated growth together on the backside of reimbursement approval.

總的來說，如果所有里程碑付款都觸發的話，這筆交易對 Personalis 來說價值約 3000 萬美元。如果坦普斯充分行使他們的認股權證。我們預計這將使我們能夠以最少的額外現金投資快速加大商業力度。我們計劃在本季與 Tempus 合作，擴大我們的搶先體驗計劃，將一些校園客戶納入其中。目標是學習如何作為合作夥伴一起工作，整合我們的業務系統，為我們向腫瘤學家傳達的訊息提供資金。因此，我們將在報銷批准的背景下共同推動加速成長。

Now while we made strides with our first group growth engine, our winning marquee strategy to establish ex personal as a leading EMR key tests. We also made progress with our second growth engine, leveraging our immuno Idenix platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies. Our biopharma segment grew 55% year over year, and we had solid performance across our product portfolio. Customers primarily use our immuno IDX. platform in two ways. First, they use our platforms to power translational research and find new biomarkers and new insights that can power their drug discovery efforts.

現在，雖然我們在第一個集團成長引擎方面取得了長足進步，但我們的致勝策略是將前個人建立為領先的 EMR 關鍵測試。我們的第二個成長引擎也取得了進展，利用我們的免疫 Idenix 平台加深與使用該產品開拓新療法的生物製藥客戶的關係。我們的生物製藥業務年增 55%，我們的產品組合表現穩健。客戶主要使用我們的免疫 IDX。平台有兩種方式。首先，他們使用我們的平台來推動轉化研究，並找到新的生物標記和新的見解，以推動他們的藥物發現工作。

Second, companies in the personalized cancer vaccine market use our platform to create a molecular fingerprint of a patient's tumor to power a personalized therapy. We previously told you about our partnership with Madonna and which maturities utilizing our platform and their mRNA cancer program matured and its partner, Merck are enrolling patients in our collaboration with modernity important driver of revenue for us in 2024 and 2025. We have several other partners that work in this space as well for their growth engine.

其次，個人化癌症疫苗市場的公司使用我們的平台創建患者腫瘤的分子指紋，以推動個人化治療。我們之前曾向您介紹過我們與Madonna 的合作夥伴關係，以及利用我們平台的成熟項目及其mRNA 癌症計劃的成熟情況，以及其合作夥伴默克(Merck) 正在招募患者參與我們與現代性的合作，這是我們2024 年和2025 年收入的重要驅動力。我們還有其他幾個合作夥伴也在這個領域工作，並為他們提供成長引擎。

Third engine of our growth strategy is growing our personnel inside approach as we service enterprise customers and these relationships partners adopt our platforms and technologies to power their solutions and provide new insights to their customers. Our work with Nanterre involves leveraging our sequencing platform to analyze the exome as a part of their MRD product. We believe our relationship is strong and mutually beneficial and are optimistic that will extend into 2025.

我們成長策略的第三個引擎是在我們為企業客戶提供服務時培養我們的內部人員，這些合作夥伴採用我們的平台和技術來支援他們的解決方案並為其客戶提供新的見解。我們與 Nanterre 的合作涉及利用我們的定序平台來分析外顯子組，作為其 MRD 產品的一部分。我們相信我們的關係牢固且互利，並樂觀地認為這種關係將延續到 2025 年。

The second important enterprise relationship is the VA the VA utilizes our whole genome sequencing capabilities to power the federal program and national research program.

第二個重要的企業關係是 VA，VA 利用我們的全基因組定序能力為聯邦計劃和國家研究計劃提供支援。

Looking at how genes and lifestyle affect the health of veterans, we've helped power this program with the VA for years. Both of these relationships are examples how our platforms drive value for partners and importantly, provide sequencing scale for Personalis.

為了研究基因和生活方式如何影響退伍軍人的健康，我們多年來一直與退伍軍人事務部一起幫助推動該計劃。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，更重要的是，如何為 Personalis 提供定序規模。

Before I turn it over to Aaron, to go deeper on the financials, I have a few exciting corporate updates. First, we continue to innovate and deepen our strong intellectual property position. We had two new patents recently issued by the US PTO. In fact, one just yesterday relating to the use of two of our core technologies, tumor-informed personalized assays in the first patents and boosted exome panels in the second patent each to inform cancer vaccine treatments.

在我將其交給亞倫之前，為了更深入地了解財務狀況，我有一些令人興奮的公司最新動態。首先，我們不斷創新並深化我們強大的智慧財產權地位。我們最近獲得了美國專利商標局頒發的兩項新專利。事實上，就在昨天，一項涉及使用我們的兩項核心技術，第一項專利中的腫瘤相關個人化檢測和第二項專利中的增強外顯子組組，每一項都為癌症疫苗治療提供資訊。

This latest patent is a fourth US patent issue in 2024. And today, our number of issued US patents has over 30. We believe we have a deep set of IP, protecting our pioneering work from both MRD. and PCV. We are engaged in litigation with Foresight diagnostics to enforce and protect some of our IP relating to MRG is often the case. There will be ups and downs along the way in that journey. However, we are confident we're set up for long term success to establish an industry leading position around the use of whole genome sequencing for MRG and are optimistic about the path forward. And second, we crossed two milestones. This quarter, we processed our 400,000 samples since our company's inception. And importantly, we completed our 175th thousand whole genome sequencing sample. Whole-genome is the foundation of our NeXT Personal MRD tests. And these milestones underline both our sequencing scale and unique operational capabilities.

這項最新專利是 2024 年頒發的第四項美國專利。如今，我們已授權的美國專利數量已超過 30 項。我們相信我們擁有一套深厚的智慧財產權，可以保護我們的開創性工作免受 MRD 的影響。和PCV。我們與 Foresight Diagnostics 進行訴訟，以強制執行和保護我們與 MRG 相關的一些智慧財產權，這種情況經常發生。在那段旅程中，將會有風風雨雨。然而，我們相信，我們已經做好了長期成功的準備，圍繞 MRG 全基因組測序的使用建立行業領先地位，並對未來的道路持樂觀態度。其次，我們跨越了兩個里程碑。自公司成立以來，本季我們處理了 40 萬個樣本。重要的是，我們完成了第 17.5 萬個全基因組定序樣本。全基因組是我們 NeXT 個人 MRD 測試的基礎。這些里程碑凸顯了我們的定序規模和獨特的營運能力。

With that, I will now turn it over to Aaron to review our financial results.

現在，我將把它交給亞倫來審查我們的財務表現。

Our strong first quarter 2024 financial results demonstrate our ongoing commitment to execution against our milestones and scaling revenue. I will be providing details about the first quarter financial results and guidance for the second quarter and full year of 2024. Total company revenue for the first quarter 2024 was $19.5 million and increased 4% compared to $18.9 million for the same period of the prior year. The increase in revenue was driven by higher volume from biopharma and personalized cancer vaccine customers, which was partially offset by declines from the tariffs and the VA MVP.

我們強勁的 2024 年第一季財務表現證明了我們對執行里程碑和擴大營收的持續承諾。我將提供有關第一季財務業績的詳細資訊以及第二季和 2024 年全年的指導。2024 年第一季公司總營收為 1,950 萬美元，較上年同期的 1,890 萬美元成長 4%。收入的成長是由生物製藥和個人化癌症疫苗客戶的銷售增加所推動的，但關稅和 VA MVP 的下降部分抵消了收入的成長。

Biopharma revenue grew 55% as compared to the same period last year. And the growth was from immuno Idenix and also from our MRD tests ex personal, which is beginning to ramp up with many customers. In addition, we achieved a significant milestone and recognized our first clinical revenue in the amount of $0.2 million from NeXT Dx for which we receive Medicare reimbursement coverage in January of this year.

生物製藥收入較去年同期成長55%。成長來自免疫 Idenix 以及我們的個人 MRD 測試，該測試已開始在許多客戶中增加。此外，我們還實現了一個重要的里程碑，並從 NeXT Dx 獲得了 20 萬美元的第一筆臨床收入，我們於今年 1 月獲得了醫療保險報銷。

Gross margin was 20.1% for the first quarter compared to 25.1% for the same period of the prior year. The year-over-year increase of three percentage points was primarily due to favorable customer mix from the increase in biopharma revenue and also operating leverage from the increase in total company revenue.

第一季毛利率為 20.1%，去年同期毛利率為 25.1%。年比成長三個百分點主要是由於生物製藥收入增加帶來的有利客戶組合以及公司總收入增加所帶來的營運槓桿。

Operating expenses were $24.4 million in the first quarter compared with $34.6 million for the same period of the prior year. Most of the year-over-year decrease was attributed to the actions taken to reduce headcount in 2023. R&D expense was $12.8 million in the first quarter compared with $16.6 million for the same period of last year.

第一季營運費用為 2,440 萬美元，上年同期營運費用為 3,460 萬美元。年比減少的大部分歸因於 2023 年採取的裁員行動。第一季研發費用為 1,280 萬美元，去年同期為 1,660 萬美元。

And SG&A expense was $11.6 million compared to $14.1 million for the same period last year. Net loss for the first quarter was $13 million compared to $28.7 million for the same period of the prior year. The first quarter net loss included a $4.8 million noncash gain related to fair value accounting of the outstanding warrants issued to Tempus. The nonstandard income was a result of the decrease in fair market value of the warrants at March 31st, 2024, compared with the fair market value at the end of last quarter. And for clarification, the accounting implications for the Group earnings will have no bearing on the cash value if they are exercised in the future.

SG&A 費用為 1,160 萬美元，去年同期為 1,410 萬美元。第一季淨虧損為 1,300 萬美元，而上年同期淨虧損為 2,870 萬美元。第一季淨虧損包括與向 Tempus 發行的未償認股權證的公允價值會計相關的 480 萬美元非現金收益。非標準收入是由於2024年3月31日認股權證的公平市價較上季末的公平市價下降所致。需要澄清的是，如果未來行使現金價值，對集團收益的會計影響將不會對現金價值產生影響。

Now onto the balance sheet, we finished the first quarter with a strong balance sheet with cash and short-term investments of $95.4 million. During the quarter, we used $18.8 million to fund operations. And we have approximately two years of cash on the balance sheet, which is expected to last through the first quarter of 2026.

現在來看資產負債表，我們第一季的資產負債表表現強勁，現金和短期投資達 9,540 萬美元。本季度，我們使用了 1880 萬美元來資助營運。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 second quarter of 2024. We expect total company revenue in the range of $19.5 million to $20.5 million revenue from pharma tests, enterprise sales and other customers in the range of $18 million to $19 million and revenue from population sequencing of approximately $1.5 million.

現在我想談談 2024 年第二季的指導。我們預計公司總收入在 1,950 萬美元到 2,050 萬美元之間，來自藥物測試、企業銷售和其他客戶的收入在 1,800 萬美元到 1,900 萬美元之間，來自群體定序的收入約為 150 萬美元。

And for the full year of 2024, we now expect total company revenue in the range of $76 million to $78 million, an increase from the prior estimate of $73 million to $75 million. Revenue from pharma tests, enterprise sales and other customers in the range of $68 million to $70 million, which increased from the prior estimate of $65 million to $67 million. Population sequencing revenues to be approximately $8 million.

對於 2024 年全年，我們預計公司總收入將在 7,600 萬美元至 7,800 萬美元之間，高於先前估計的 7,300 萬美元至 7,500 萬美元。藥物測試、企業銷售和其他客戶的收入在 6,800 萬美元至 7,000 萬美元之間，從先前估計的 6,500 萬美元增加至 6,700 萬美元。群體定序收入約 800 萬美元。

Non-GAAP net loss of approximately $77 million, which decreased from the prior estimate of $80 million, and it does not include any income or expense related to the outstanding warrants issued to Tempus. And cash usage is expected to be approximately $62 million. And we look forward to updating you on our progress during the next conference call in a few months.

非公認會計準則淨虧損約為 7,700 萬美元，較先前估計的 8,000 萬美元有所下降，且不包括與向 Tempus 發行的未償還認股權證相關的任何收入或費用。預計現金使用量約 6,200 萬美元。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 and begin the Q&A session.

然後，我會將電話轉回接線生並開始問答環節。

(Operator Instructions) Hugo Koh, Morgan Stanley.

（操作員指令）Hugo Koh，摩根士丹利。

My team this is Madison on for you to, and congrats on the quarter. Thanks for taking the question. And just wanted to start out with the finalization of the FDA's LDT regulation. I'm just wondering if you could speak to your strategy in adhering to their requirements and what kind of implications for personnel Personalis are expecting with respect to next, the accident, personal?

我的團隊這是麥迪遜為你們準備的，恭喜本季。感謝您提出問題。我只想從最終確定 FDA 的 LDT 法規開始。我只是想知道您是否可以談談您在遵守他們的要求方面的策略，以及 Personalis 預計對下一個事故、個人事故會產生什麼樣的影響？

Yes, awesome. Great. Thanks. Thanks for being on Madison. Yeah, the FDA issued their final guidance for regulations and an overall we perceived it to be good for the industry. Certainly good for Personalis. And we have a quality management system here that we think is super robust. We're regularly inspected by most of all the large biopharma companies we've been operating with ISO certification, New York, et cetera. And we think that what we're doing sort of fits in well with what the agency expects based on the guidance.

是的，太棒了。偉大的。謝謝。感謝您來到麥迪遜。是的，FDA 發布了最終的法規指南，總體而言，我們認為這對產業有利。對於 Personalis 來說當然有好處。我們這裡有一個我們認為非常強大的品質管理系統。大多數我們一直在紐約等地運作並獲得 ISO 認證的大型生物製藥公司都會定期對我們進行檢查。我們認為我們正在做的事情與該機構根據指導意見所期望的非常吻合。

And so we feel like we're we're set up well and we think ultimately, it's good for us. We'll note that, you know, there were the grandfathering section around having adults to live. We have both of those tests are laboratory-developed test and are both on our both are both on the market as of the effective date of the FDA guidance. So we think that's that's good. And secondarily up because of our long relationship with New York and having New York certification, we submitted both of the tests for New York for New York approval. And so ultimately, we expect to have New York approval for both testosterone. So we think it's net-net a positive for Personalis and puts us in a good position.

所以我們覺得我們已經準備好了，我們認為最終這對我們有好處。我們會注意到，你知道，有關於讓成年人生活的祖父部分。我們的這兩項測試都是實驗室開發的測試，並且自 FDA 指南生效之日起均已上市。所以我們認為這樣很好。其次，由於我們與紐約的長期合作關係並擁有紐約認證，我們向紐約提交了兩項測試以獲得紐約批准。因此，最終，我們預期這兩種睪固酮都能獲得紐約的批准。因此，我們認為這對 Personalis 來說是積極的，並使我們處於有利地位。

Got it. Apparent that this year and then just one follow-up one with following the recent AdCom meeting to evaluate MRD and endpoint and multiple melanoma trial, just wondering, beginning with the U.S., our solid tumor space and specifically with the panel emphasizing some sensitivity, how do you see next personal position for capturing clinical trial opportunity?

知道了。顯然，今年，然後只是在最近的AdCom 會議之後進行一次後續會議，評估MRD 和終點以及多發性黑色素瘤試驗，只是想知道，從美國開始，我們的實體瘤領域，特別是強調一些敏感性的小組，如何您認為抓住臨床試驗機會的下一個個人職位是什麼？

I would just note, I mean, one of the one of the things. I think these two dovetail together out there is I mean, clearly what the agency did with the unanimous approval of using that multiple myeloma is blood-based.

我只想指出其中一件事。我認為這兩者是吻合的，我的意思是，很明顯，該機構在一致批准使用多發性骨髓瘤是基於血液的情況下所做的事情。

We expect this to continue the march solid tumor. And I think that the new guidance and having the LDT and the quality management systems, et cetera, it's going to make it harder for companies that are well-funded ultimately to build to get the kind of position in the space that you would need to do. So I think it sort of works. It works together well, especially if you use if you if you appreciate that the FDA is going to integrate, we believe, at some point CTG. and A. as auditory metrics for these clinical trials doing that can allow biopharma companies to resolve ourselves sooner and ultimately speed up access to drugs for patients who are engaged with most of the most of the top biopharma companies right now that are either using the technology, assessing the technology or or are doing pilots or bake-offs.

我們預計這將繼續實體瘤的進軍。我認為，新的指導方針以及 LDT 和品質管理系統等，對於資金充足的公司來說，最終要在該領域獲得所需的地位將變得更加困難。所以我認為這確實有效。它可以很好地協同工作，特別是當您意識到 FDA 將在某個時候整合 CTG 時，尤其如此。 A.作為這些臨床試驗的聽覺指標，可以讓生物製藥公司更快地解決問題，並最終加快目前與大多數頂級生物製藥公司合作的患者獲得藥物的速度，這些患者要么正在使用該技術，評估技術或正在進行試點或烘烤。

And there's always a long sales cycle with biopharma with these with these products but the ultra sensitive nature allows them, we believe, and we're starting to see in the data that were and we're both talking about at industry on scientific gatherings and what we're starting to see in our early testing data is that we're seeing almost 40% of the positive results are in the ultra-sensitive range. And those are those are real patients that we're identifying cancer sooner and that insight and that discrimination is appealing to biopharma companies to want to have that discrimination in their clinical trials. And they want to make sure if they use a test as an entry point to actually take the drug go into two arms. We want to make sure that the patients that are most likely to recur ultimately enter the trial. And so we're getting really positive feedback on the assay and that way to panel.

生物製藥的銷售週期總是很長，但我們相信，超敏感的性質允許它們，並且我們開始在行業中談論的科學收集和數據中看到這些數據。 40% 的陽性結果都在超敏感範圍內。這些是我們更快識別癌症的真實患者，這種洞察力和歧視正在吸引生物製藥公司希望在其臨床試驗中進行這種歧視。他們想確定是否使用測試作為切入點來真正將藥物分為兩部分。我們希望確保最有可能復發的患者最終進入試驗。因此，我們得到了有關檢測和小組的非常積極的回饋。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

This is Janine on for Mark. Thanks for taking the questions. First for Dr. Stein to raise to the guidance and beyond the beat and the number of offerings, some of which are newer like NeXT Personal, which might not be driving revenue out first with some more mature partnerships like Madonna. So looking to 24, just curious if there's any area in particular where you're expecting to see strength versus some product lines that might be softer base.

這是珍妮為馬克代言的。感謝您提出問題。首先，Stein 博士提出了指導意見，並超越了節拍和產品數量，其中一些是較新的，例如 NeXT Personal，這可能不會首先透過像 Madonna 等更成熟的合作夥伴來推動收入。因此，展望 24，只是想知道是否有任何特定領域您希望看到實力，而某些產品線可能基礎較弱。

And again, this is Aaron. Thank you for the question and being on the call in terms of the guidance. So we raised guidance primarily because of the strength of biopharma demand in terms of where that strength is coming from. So immunology Nexus is holding it up very, very well. We have a lot of pharma headwinds today. But in terms of the opportunity, it's really with NeXT Personal. And we have we've done really well in the first quarter with NEXT personal and we have a tremendous funnel that's building. And we see that the growth is going to accelerate as we head through the back half of 2024 with some and next person. In addition, as Chris mentioned in the prepared remarks that we are seeing strength from the personalized cancer vaccine side of the business as well. And that's, again off of REVLIMID platform as a perfect on Yandex.

再說一遍，這是亞倫。感謝您提出問題並接受電話指導。因此，我們提出指導意見主要是因為生物製藥需求的強勁，以及這種強勁的來源。所以免疫學 Nexus 的表現非常非常好。今天，我們面臨著許多製藥業的不利因素。但就機會而言，NeXT Personal 才是真正的機會。我們在第一季的 NEXT 個人方面做得非常好，我們正在建立一個巨大的管道。我們看到，隨著我們與一些人和下一個人一起度過 2024 年下半年，成長將會加速。此外，正如克里斯在準備好的演講中提到的那樣，我們也看到了個人化癌症疫苗業務的優勢。這也是 REVLIMID 平台在 Yandex 上的完美表現。

And that dovetails into my next question to the three 38 NeXT Personal test, it was great to see and how you're expecting that to ramp throughout the year after Tempus starts, marketing it as well. And just wanted to get a sense if reimbursement either has to be more of a 2025 event or if there is any updated timing there now?

這與我對三個 38 NeXT 個人測試的下一個問題相吻合，很高興看到 Tempus 啟動後全年的銷量以及行銷情況。只是想了解報銷是否必須更多地在 2025 年進行，或者現在是否有任何更新的時間表？

I mean, our goal this year is to submit the share for all three cancer indications in I'll answer and stitch it together. And we think that the data's coming together to allow us to do that. We talked in the prepared remarks that the VHIO. and the Royal Marsden data would be featured at Asco on a podium presentation, which we think is he's great and we're tracking to be able to get the data ultimately submitted for publication published to be able to to be able to submit across the three indications for coverage in 2024, which is which is our stated goal now that's aggressive on will continue to grow the number of doctors that are in the AP. through our own efforts slowly through our own efforts and then with Tempus. And so we'll see the number of patients referred to us for NeXT Personal testing continuing to grow through the year.

我的意思是，我們今年的目標是在「我將回答並將其縫合在一起」中提交所有三種癌症適應症的份額。我們認為，這些數據的匯集使我們能夠做到這一點。我們在準備好的演講中談到了 VHIO。皇家馬斯登的數據將在阿斯科的講台上展示，我們認為他很棒，我們正在追蹤最終提交出版的數據，以便能夠在三個領域提交2024 年覆蓋的跡象，這是我們現在的既定目標，我們將繼續努力增加AP 的醫生數量。透過我們自己的努力，慢慢地通過我們自己的努力，然後與Tempus一起。因此，我們將看到轉介我們進行 NeXT Personal 測試的患者數量在這一年中持續增加。

Maybe just an add on to what Chris just articulated Viviant. So we're seeing great strength. We have a lot of demand with doctors wanting to participate in the program. Number of tests are continuing to grow, but there's a balance, we're going to be a little bit careful with how much we've taken perform tests on primarily because of reimbursement rate. But we don't want to just burn a lot of cash. We want to make sure we learn we want to ramp, but also there's cash component of it.

也許只是對 Chris 剛剛闡述的 Viviant 的補充。所以我們看到了巨大的力量。我們有很多想要參與計劃的醫生的需求。測試數量持續增加，但存在平衡，我們將謹慎對待我們進行的測試數量，主要是因為報銷率。但我們不想僅僅燒掉大量現金。我們希望確保我們知道我們想要擴大規模，但其中也有現金部分。

One of the question, yes, one of them, one of the neat things about this relative to volume growth from an investor standpoint, it's always been appealing about the MRD market is there's always an annuity right issue as you build the first baseline test you repeat test over and over time as patients sort of go through their cancer journey is continuing continued testing of personalized genetic fingerprints that you create for the patient and so we're seeing that happen. We're seeing nice growth in the repeat test of the patients that we that we that were referred to us previously, which is a really great dynamic in the space and thanks, guys.

其中一個問題，是的，其中之一，從投資者的角度來看，相對於交易量增長，MRD 市場一直很有吸引力，那就是當你建立第一個基線測試時，總是存在年金問題。我們在對先前轉介給我們的患者進行重複測試時看到了良好的成長，這在這個領域確實是一個巨大的動態，謝謝大家。

It should be.

應該是的。

Dan Brennan, TD Cowen.

丹布倫南，TD·考恩。

It's Joe on for Dan. Thanks for taking them on again, a little bit more on the 330 MRD test. What do you need to see to open that with the substitute [50 docs] that you mentioned in Q4? Is that more capacity or demand? Or is it really just holding back tests until you get more widespread reimbursement? So maybe is there like what sort of cap you're thinking about for annual volumes before you get coverage on the three times?

由喬代替丹。感謝您再次接受他們的邀請，進一步了解 330 MRD 測試。您需要看到什麼才能使用您在第四季度中提到的替代品 [50 個文件] 打開它？這是更多的容量還是更多的需求？或者它真的只是推遲測試，直到你得到更廣泛的報銷嗎？那麼，在您獲得三次報道之前，您是否正在考慮年度銷售的上限？

Yes, the latter, we're moving really slow down because of reimbursement. And one of the one of the things I think that's obvious by looking at all the progress that we made through 2023 at bringing down the burn rate of the Company, extending the cash out of the company is that we're being very thoughtful about where and how we spend the resources that we have.

是的，是後者，由於報銷，我們的行動速度確實減慢了。我認為，透過觀察 2023 年我們在降低公司燒錢率、擴大公司現金支出方面取得的所有進展，我認為顯而易見的一件事是，我們正在非常仔細地考慮在哪裡以及我們如何使用我們擁有的資源。

And so it's really important through this journey that we build advocates for the products that we continue to build clinical evidence that we continue to learn the right way to position talk about the products and that we test the relationship with with Tempus, and we really get to the point where we feel confident that once we get reimbursement, we can pull the trigger and go super fast. But until we get reimbursement, we're not planning on going super fast because it's we don't get paid for those samples and data. We want to make sure that we're really thoughtful and doing the right thing with eight bit investors money.

因此，在這過程中，我們為產品建立擁護者非常重要，我們繼續建立臨床證據，我們繼續學習定位談論產品的正確方法，並測試與 Tempus 的關係，我們真的得到了以至於我們有信心一旦獲得報銷，我們就可以扣動扳機並快速行動。但在我們獲得報銷之前，我們不打算超快地進行，因為我們不會因為這些樣品和數據而獲得報酬。我們希望確保我們真正考慮周全，並用八位投資者的資金做正確的事情。

Got it. And then on the burn, does the two years of cash assume or even revenue level like at or around $100 million now that you've implemented your $100 million in 2025 framework? Or is it closer to like consensus was a little bit lower?

知道了。然後，既然您已經實施了 2025 年 1 億美元的框架，那麼兩年的現金是否假設甚至收入水準達到或約為 1 億美元？還是更接近共識，但稍微低一點？

Hey, Joe. Yes. So in terms of the burn, we've mentioned the cash will last through the end of the first quarter of 2026. So it does contemplate it's something that's close to that $100 million range in 2025.

嘿，喬。是的。因此，就燒錢而言，我們提到現金將持續到 2026 年第一季末。因此，它確實預計到 2025 年這一數字將接近 1 億美元。

And then just last on the patent, is the core IP that you're enforcing specific to whole genome sequencing and far tumor solid tumor? Or are there other key aspects of IP that and again, I mean, we're a relative relative to MRD., very broad of both MRDMPCB., very broad, both around whole genome at that, the way in which we and the way in which we do process. And then there's IP that was mentioned around the exome and the way we boost the exome it relative to its use in PCB.

最後，關於專利，您正在執行的核心智慧財產權是否特定於全基因組定序和遠腫瘤實體瘤？或者 IP 是否還有其他關鍵方面，我的意思是，我們與 MRD 是相對的。然後是圍繞外顯子組提到的 IP，以及我們相對於 PCB 中的使用來增強外顯子組的方式。

And I point out I've mentioned it right, is just to underline because we spent a lot of time significant energy building the protections around what we're doing and we continue to make progress. And we've been mostly focused on driving the business really aggressively towards MR depot. But we wanted to make sure we underline that there is a deep amount of IP here that we think is building getting stronger and that we continue to work on and evolving and extending as we as we invest in R&D and so we had some success this quarter and we wanted to touch part of our ongoing journey.

我指出，我已經提到了這一點，只是為了強調，因為我們花了很多時間、大量精力圍繞著我們正在做的事情建立保護措施，並且我們繼續取得進展。我們主要致力於推動業務真正積極地走向 MR depot。但我們想確保強調，這裡有大量的知識產權，我們認為這些知識產權正在變得越來越強大，並且我們在投資研發的過程中繼續努力、發展和擴展，因此本季度我們取得了一些成功我們想要觸及我們正在進行的旅程的一部分。

Thomas Flaten, Lake Street.

托馬斯·弗拉頓，湖街。

Hey, good afternoon, guys. Appreciate you taking the questions. I just wanted to clarify something with the Trade Direct collaboration, the publication that you will use for your reimbursement dossier will that be the initial as well cohort? Or will that be a publication covering the full cohort, which we expect to see a readout on later this year?

嘿，下午好，夥計們。感謝您提出問題。我只是想透過 Trade Direct 合作澄清一些事情，您將用於報銷檔案的出版物將是第一個隊列嗎？或者這會是一份涵蓋整個隊列的出版物，我們預計將在今年稍後看到它的讀數？

Thomas Richards is with us. So he is going to take that one fit one.

托馬斯·理查茲和我們在一起。所以他會選擇一個合適的人選。

Yes, the publication that will support our reimbursement will be the second publication that that entails the entire cohort so that we're targeting for kind of later this year. And the first was the publication will come out, but it's only a subset of the data that we have.

是的，支持我們報銷的出版物將是第二份涉及整個隊列的出版物，因此我們的目標是在今年稍後。第一個是出版物將會發布，但這只是我們擁有的數據的子集。

Got it. And then, Chris, I want to make sure I didn't misunderstand what you said, but did you did you say that the material relationship could persist into 2025 or did I misunderstand that?

知道了。然後，克里斯，我想確保我沒有誤解你所說的話，但是你是說物質關係可以持續到 2025 年還是我誤解了？

You said that we have a great working relationship and we're optimistic it is that it will that we will continue to work with them into 2025.

您說我們有著良好的工作關係，我們樂觀地認為我們將繼續與他們合作到 2025 年。

And if I could just add and add a third one, the have you discussed with Tempus and maybe they haven't an alternate solution of adding NeXT Dx. It strikes me that being able to order both tests through one through one sales channel would make sense, but how are you thinking about those two tests working in synergy with each other long term?

如果我可以添加並添加第三個，您是否與 Tempus 討論過，也許他們沒有添加 NeXT Dx 的替代解決方案。讓我印象深刻的是，能夠透過一對一的銷售管道訂購這兩種測試是有意義的，但是您如何看待這兩種測試如何長期協同工作？

Yes. So from where we are seeing NeXT Dx being ordered with NeXT Personal and our early access clients and that demand is strong. What we're seeing in the marketplace. And I think everyone is seeing in the marketplace is that the power of the MRD testing is unique differentiated and the CGP. testing physicians are seeing more in a way that they're more interchangeable. And so there are there. They're ordering as CGP. test paired with the MRD. as a convenience play, same patient same tissue, same, et cetera. And so we're certainly seeing that of Tempus as their own MRD. test. And so through the samples, not MRD test their own CGP. test, excuse me. And so they will be and then we don't be providing that. Now I'd like to do it at their customers. And so we expect the NeXT Dx our approach to only come through with the doctors that we sell ourselves.

是的。因此，我們看到 NeXT Personal 和我們的搶先體驗客戶正在訂購 NeXT Dx，需求非常強勁。我們在市場上看到的。我認為市場上每個人都看到 MRD 測試的力量與 CGP 有著獨特的差異化。測試醫生正在以更具可互換性的方式看到更多的東西。所以就有了。他們以 CGP 身份訂購。與 MRD 配對的檢定。作為一種方便的遊戲，同一患者相同的組織，相同的等等。因此，我們當然將 Tempus 視為他們自己的 MRD。測試。等通過樣本，不是MRD測試自己的CGP。測試一下，不好意思。所以他們會這樣，然後我們就不提供了。現在我想為他們的客戶做這件事。因此，我們預計 NeXT Dx 我們的方法只能透過我們自己推銷的醫生來實現。

Mike Matson, Needham.

麥克馬森，李約瑟。

This is Joseph on for Mike. Maybe just one on pharma demand on the obviously, as you guys said, you've seen increase in demand there. Is that mainly coming from and I guess new customers coming back in are more existing customers kind of expanding their order books, maybe there's similar customers that we've had up to now.

這是麥克的約瑟夫。也許只是關於藥品需求的一個，顯然，正如你們所說，你們已經看到那裡的需求增加。這主要是來自，我想回來的新客戶更多是現有客戶，他們正在擴大他們的訂單，也許到目前為止我們已經擁有了類似的客戶。

So it's not really new customers, just the expansion of the order book and the opportunity. In addition, the modernity relationship has been strong and that business has started to increase as well.

所以這不是真正的新客戶，只是訂單的擴大和機會。此外，現代性關係也很牢固，業務也開始增加。

Yes. And then at the first moment, we basically have that turns into the use of immuno ID. and PCV. is really starting to accelerate as our current data enroll the patients in their clinical trials and then X personnel being a new product and the biopharma starting to grow. And so that those two things are really starting to put wins to our sales relative to finish.

是的。然後在第一時刻，我們基本上將其轉變為免疫 ID 的使用。和PCV。隨著我們目前的數據將患者納入臨床試驗，然後 X 人員成為新產品，生物製藥開始發展，這確實開始加速。因此，這兩件事確實開始為我們的銷售帶來勝利。

Got you. And then maybe just in there for the early access program for next personal. And I guess, do you have, I guess, an engagement rate for those using NeXT Dx on then, I guess was that a full quarter that you guys kind of launched NeXT Dx AM?

明白你了。然後也許只是在那裡參加下一個人的搶先體驗計劃。我想，我猜，那些使用 NeXT Dx 的人的參與率，我猜你們推出了 NeXT Dx AM 的整整一個季​​度？

Yes, yes, the NeXT Dx, we so NeXT Dx, we launched some, I would say, year and a half ago, and we kept it very, very, very small. And it was and it was used by a few physicians when we launched NeXT Personal as an LDT laboratory developed test in October. That's when we started to see next personnel being used side-by-side with or the next the next DXCGP. product be used with CMRG product side by side. And I think I mean, I'll have to check with the adoptions been wide across the entire 10 people in the EAP program. I don't know if I can say they're all done that, but certainly a significant majority. Most of them have been using NeXT Dx same time that they use X personnel.

是的，是的，NeXT Dx，我們所以 NeXT Dx，我們在一年半前推出了一些，並且我們保持它非常非常小。當我們在 10 月推出 NeXT Personal 作為 LDT 實驗室開發的測試時，它確實被一些醫生使用了。從那時起，我們開始看到下一個人員與下一個 DXCGP 並排使用。產品可與 CMRG 產品並列使用。我想我的意思是，我必須檢查 EAP 計劃中所有 10 個人的廣泛採用。我不知道是否可以說他們都這麼做了，但肯定是絕大多數。他們中的大多數人在使用 X 人員的同時也在使用 NeXT Dx。

And then just maybe one last one on for the molecular or I guess for the physicians in the quarter, I guess for the test, is there an average test per patient you guys are seeing?

然後可能是分子的最後一個，或者我想對於本季度的醫生，我想對於測試，你們看到的每個病人是否有平均測試？

I don't think we have enough time to review any more time on that path about an average tenure per patient here because I think a lot of these people are new to these, but we are starting to see the repeat testing, in fact, because when you're fixed at 10 physicians a lot of times in these hyper growth mode in these companies launches, you're also you're starting to really sign up a lot new doctors that so your V ones are always growing at a dramatic rate because you're driving or doctors in a world where we fixed the doctors, we want to launch into a rhythm of getting the clinical samples coming from those doctors.

我認為我們沒有足夠的時間來審查每個患者的平均任期，因為我認為很多人都是新的，但事實上，我們開始看到重複測試，因為當你在這些公司推出的超增長模式中多次固定為10 名醫生時，你也開始真正簽約很多新醫生，所以你的V 醫生總是以驚人的速度增長因為在我們固定醫生的世界裡，你是司機或醫生，我們希望啟動從這些醫生在那裡獲取臨床樣本的節奏。

Now we've hit the point where the repeat testing is starting to how pays but weekly new tests coming in right on just because it's starting to accelerate. So we'll we'll we'll come up with a way that we ultimately talk about that metric. But I don't think we have any insight right now? Well, relative relative to the number of tests per patient. But I think as we get a year two years in the rearview mirror, even when it starts to kind of.

現在我們已經達到了重複測試開始帶來回報的地步，但每週的新測試馬上就會到來，因為它開始加速。因此，我們將想出一種最終討論該指標的方法。但我認為我們現在沒有任何洞察力？嗯，相對於每個患者的測試數量而言。但我認為，當我們在後視鏡中度過一年兩年時，即使它開始出現這種情況。

Arthur He, H.C. Wainwright.

何亞瑟，H.C.溫賴特。

So I guess I just wanted to get a quick question regarding the early access program for the personal Dx of our with for this program for I know you mentioned a doctor on the waiting list at the beginning. I'm just curious, is deal is there any more doctors getting on the wellness and the game longer was closed?

所以我想我只是想問一個關於我們個人 Dx 的早期訪問計劃的快速問題，因為我知道您一開始就提到了等待名單上的一位醫生。我只是好奇，是否有更多的醫生進行健康檢查並且遊戲關閉的時間更長？

Well, there was growth there. And yes, we are there is there has been growth and quote the waiting list. We just decided we're not going to track that quarter over quarter. We thought that the reported test was the best way to sort of provide to provide insight, but we are we do have a wait list and then Tempus is starting their discussions. And so we expect there to be a pent-up demand and they're creating two up separately as they engage with with customers and discussions.

嗯，那裡有成長。是的，我們的等候名單有所增長並引用。我們剛剛決定不逐季度追蹤該情況。我們認為報告的測試是提供見解的最佳方式，但我們確實有一個等待名單，然後 Tempus 就開始了他們的討論。因此，我們預期會有被壓抑的需求，他們在與客戶互動和討論時會分別創造兩個需求。

Got you. Thanks for the additional color. And regarding the reimbursed application of you guys mentioned the aim for the I'm trying to get to the four or three indication down of this year. Besides the data package you prepared for that, what are other things you guys prepared to can increase the chance for getting the reimbursement approved?

明白你了。感謝您提供額外的顏色。關於你們的報銷申請，我提到了今年的目標，我正在努力達到四到三個指標。除了你們準備的資料包之外，你們還準備了哪些東西可以增加報銷獲得批准的機會？

Yes, great question. So the key thing is the data package. Now, you know, one of the one of the things that we happened to us earlier in this quarter, is that we the analytics and analytical validation data, which looked really, really strong, was published. And that is that is the backbone of every one of the submissions that's a test gives an answer across multiple cancer types out of the one part per million. It does that with really high specificity. And so that that's the backbone of every submission. Whenever you do this, the analytic validation data. And this was really strong, really robust agenda and a lot of studies, a lot of work that went into it. We're really proud of it and super excited that it got published so quickly.

是的，很好的問題。所以關鍵是資料包。現在，您知道，本季早些時候發生的一件事是我們發布了看起來非常非常強大的分析和分析驗證數據。這就是每份提交資料的主幹，即一項測試可以為多種癌症類型提供百萬分之一的答案。它以非常高的特異性做到這一點。這就是每份提交的主幹內容。每當您執行此操作時，都會分析驗證資料。這是一個非常強大、非常強有力的議程，並且進行了大量的研究和工作。我們對此感到非常自豪，並且對於它如此迅速地發布感到非常興奮。

So that's sort of the backbone of all three. And then we have to get up. You have to get clinical data in each one of these three. So you know, for for lung cancer, early-stage lung cancer to work with tracer X is key there with breast cancer that work with the Royal Marsden is key there because that's multiple cancer subtypes. But we're also working with Dana-Farber. We're working with MS and RA, triple-negative breast cancer patients. We have our own. We have spot clinical trial. We're doing ourselves called the stronger immunotherapy. We've got the UK data with melanoma. We've got to do data with cash, gastric patients. And then we've got the large HIO. data.

所以這是這三個方面的支柱。然後我們必須起床。您必須獲得這三項中每一項的臨床數據。所以你知道，對於肺癌，早期肺癌使用示蹤 X 是關鍵，而乳癌，使用皇家馬斯登是關鍵，因為這是多種癌症亞型。但我們也正在與丹娜—法伯癌症研究所合作。我們正在與 MS 和 RA、三陰性乳癌患者合作。我們有自己的。我們有現場臨床試驗。我們正在做自己所謂的更強的免疫療法。我們有英國黑色素瘤的數據。我們必須與現金、胃病患者進行數據處理。然後我們就有了大型 HIO。數據。

And so we continue to make progress running those samples. The key thing there is that collaborators will need to write the articles and they have to submit those articles and those articles have to be ultimately be accepted for us to for us to for us to drive submissions. And so the one piece of this that is always difficult to predict is how long it takes collaborators to write particles and to submit articles and ultimately for those articles to get aren't close to be to be accepted. But we've been very focused on driving this. So that all that comes together this year, and that's been that's been our goal. And right now we're on a plan to accomplish.

因此，我們在運行這些樣本方面繼續取得進展。關鍵在於合作者需要撰寫文章，他們必須提交這些文章，這些文章必須最終被我們接受，以便我們推動提交。因此，始終難以預測的一個問題是，合作者需要多長時間來編寫粒子並提交文章，而最終這些文章還沒有被接受。但我們一直非常專注於推動這一目標。因此，今年所有這些都匯集在一起，這就是我們的目標。現在我們正在製定一個要完成的計劃。

This concludes our question and answer session as well as conference. Thank you for attending today's presentation. You may now disconnect.

我們的問答環節和會議到此結束。感謝您參加今天的演講。您現在可以斷開連線。

Thanks.

謝謝。