Adaptive Biotechnologies Corp (ADPT) 2025 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to the Adaptive Biotechnologies second-quarter 2025 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Adaptive Biotechnologies 2025 年第二季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your first speaker today, Karina Calzadilla, Vice President, Investor Relations and FP&A. Please go ahead.

現在，我想將會議交給今天的第一位發言者，投資者關係和 FP&A 副總裁 Karina Calzadilla。請繼續。

Thank you, Shannon. And good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies' second-quarter 2025 earnings conference call. Earlier today, we issued a press release reporting Adaptive's financial results for the second quarter of '25. The press release is available at www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the Investor section of our corporate website.

謝謝你，香農。大家下午好。歡迎您參加 Adaptive Biotechnologies 2025 年第二季財報電話會議。今天早些時候，我們發布了一份新聞稿，報告了 Adaptive 25 年第二季的財務表現。新聞稿可在 www.adaptivebiotech.com 上查閱。我們將對本次電話會議進行網路直播，並將參考已發佈於公司網站「投資者」板塊的幻燈片簡報。

During the call today, management will make projections and other forward-looking statements within the meaning of federal security laws regarding future events and the future financial performance of the company. These statements reflect management's perspective of the businesses of today. Actual results may differ materially from today's forward-looking statements depending on a number of factors which are set forth in our public filings with the SEC and listed in this presentation.

在今天的電話會議中，管理層將根據聯邦安全法的定義對未來事件和公司未來財務表現做出預測和其他前瞻性陳述。這些聲明反映了管理層對當今企業的看法。實際結果可能與今天的前瞻性陳述有重大差異，這取決於我們向美國證券交易委員會提交的公開文件中所闡述的以及本簡報中列出的許多因素。

In addition, non-GAAP financial measures will be discussed during the call, and a reconciliation from non-GAAP to GAAP metrics can be found in our earnings release. Joining the call today are Chad Robins, our CEO and Co-Founder; and Kyle Piskel, our Chief Financial Officer. Additional members from management will be available for Q&A.

此外，電話會議期間將討論非公認會計準則 (non-GAAP) 財務指標，非公認會計準則 (non-GAAP) 與公認會計準則 (GAAP) 指標的對帳可在我們的收益報告中找到。今天參加電話會議的有我們的執行長兼聯合創始人 Chad Robins 和我們的財務長 Kyle Piskel。其他管理層成員也將參與問答。

With that, I'll turn the call over to Chad. Chad?

說完這些，我會把電話轉給查德。查德?

Thanks, Karina. Good afternoon, and thank you for joining us on our second-quarter earnings call. Our second-quarter results demonstrate strong execution with outperformance on both the top and bottom line. In addition to delivering ahead of expectations, we're also tracking ahead of schedule on key milestones for the year, as shown on slide 3.

謝謝，卡琳娜。下午好，感謝您參加我們的第二季財報電話會議。我們第二季的業績展現出強勁的執行力，營收和獲利均表現出色。除了提前交付成果之外，我們還提前追蹤了今年的關鍵里程碑，如投影片 3 所示。

Our MRD business achieved profitability this quarter, delivering approximately $2 million in positive adjusted EBITDA, which we anticipate to increase going forward. MRD revenue grew 42% year over year, driven by significant increases in clinical volume. We successfully integrated clonoSEQ into Flatiron's OncoEMR, expanding access in the community.

我們的 MRD 業務本季實現了盈利，實現了約 200 萬美元的正調整後 EBITDA，我們預計未來這一數字還會增加。由於臨床數量的大幅增加，MRD 收入年增 42%。我們成功地將 clonoSEQ 整合到 Flatiron 的 OncoEMR 中，擴大了社群的訪問範圍。

We've begun processing clonoSEQ tests on the NovaSeq X, a major step in scaling operations and improving margins. NCCN guidelines for multiple myeloma were updated to strengthen support for ID testing at diagnosis, reducing barriers to MRD testing and helping drive volume. And we launched the first phase of our collaboration with NeoGenomics.

我們已經開始在 NovaSeq X 上處理 clonoSEQ 測試，這是擴大營運和提高利潤率的重要一步。NCCN 多發性骨髓瘤指南已更新，以加強對診斷時 ID 檢測的支持，減少 MRD 檢測的障礙並幫助提高檢測量。我們啟動了與 NeoGenomics 合作的第一階段。

Total company sequencing gross margin improved by 14 percentage points year over year to 64%, and cash burned for the quarter was approximately $11 million, representing a 36% improvement over the same period last year, ending with a solid cash position of $222 million. Given these strong results, we are again raising our four-year guidance to reflect a higher MRD revenue range and a lower annual cash burn. Kyle will share more details on this shortly.

該公司定序總毛利率年增 14 個百分點至 64%，本季現金消耗約 1,100 萬美元，較去年同期增加 36%，最終現金狀況穩健，達 2.22 億美元。鑑於這些強勁的業績，我們再次上調了四年預期，以反映更高的 MRD 收入範圍和更低的年度現金消耗。凱爾將很快分享更多有關此事的細節。

Let's now dive into the MRD business on slide 5. clonoSEQ revenue grew 57% year over year in the second quarter, driven by strong demand across all reimbursed indications. We delivered over 25,300 tests, up 37% versus prior year, and up 10% sequentially, an increase of about 2,200 tests versus Q1. Multiplie myeloma remains the largest contributor, accounting for 41% of US clonoSEQ volume, followed by ALL at 33%, CLL at 10%, DLBCL at 8%, and MCL at 5%. We continue to see positive momentum across several key growth indicators.

現在讓我們深入了解幻燈片 5 上的 MRD 業務。受所有報銷適應症的強勁需求推動，clonoSEQ 營收在第二季年增 57%。我們進行了超過 25,300 次測試，比去年同期成長了 37%，比上一季成長了 10%，比第一季增加了約 2,200 次測試。多發性骨髓瘤仍是最大的貢獻者，占美國克隆SEQ數量的41%，其次是ALL（33%）、CLL（10%）、DLBCL（8%）和MCL（5%）。我們繼續看到幾個關鍵成長指標呈現正面動能。

Blood-based testing represents 44% of MRD tests, up 40% from a year ago. In multiple myeloma, blood-based contribution rose to 23% compared to 21% last quarter. Community-based testing grew 16% quarter over quarter, reflecting our expanding footprint outside of academic centers. NHL volume rose to 14% total, up from 11% last year, led by continued growth in DLBCL and MCL. Ordering healthcare providers grew 35% over 3,700, reflecting strong provider adoption. And over 18,000 unique patients were tested in Q2, up 40% year over year and 10% sequentially.

血液檢測佔 MRD 檢測的 44%，比一年前增加了 40%。在多發性骨髓瘤中，血液治療貢獻率從上一季的 21% 上升至 23%。社區測驗季增 16%，反映出我們在學術中心以外的影響力不斷擴大。NHL 病例數從去年的 11% 上升至總體的 14%，這主要得益於 DLBCL 和 MCL 病例數的持續增長。訂購醫療保健提供者的數量增長了 35%，超過 3,700 家，反映出提供者的強勁採用率。第二季有超過 18,000 名獨立患者接受了檢測，較去年同期成長 40%，較上季成長 10%。

On the reimbursement front, ASP for clonoSEQ continued its upward trend, reaching above $1,290 per test, a 17% increase year over year. Year-to-date, we've closed or renegotiated eight key agreements with major national and regional payers, with additional agreements anticipated to close in the back half of this year. We remain confident in achieving an average ASP of $1,300 per test for fiscal year 2025 with a solid growth trajectory well into the future.

在報銷方面，clonoSEQ 的平均售價持續呈上升趨勢，每次測試達到 1,290 美元以上，年增 17%。年初至今，我們已經與主要的國家和地區付款人達成或重新談判了八項重要協議，預計今年下半年還將達成更多協議。我們仍然有信心在 2025 財年實現每次測試 1,300 美元的平均銷售價格，並且未來將保持穩健的成長軌跡。

Now let's take a look at the progress of EMR integrations on slide 6. Integrating clonoSEQ into EMR systems across academic and community settings remains a key driver of volume growth. In the academic setting, we began EPIC integration about 18 months ago and we're now live at 40 sites, including 13 added since our last call. EPIC accounts that have been live for over a year are growing on average about 2 times faster than non-integrated accounts.

現在我們來看看幻燈片 6 上 EMR 整合的進展。將 clonoSEQ 整合到學術和社區環境中的 EMR 系統中仍然是數量增長的關鍵驅動力。在學術環境中，我們大約 18 個月前開始進行 EPIC 集成，現在我們已經在 40 個站點上線，其中包括自上次通話以來新增的 13 個站點。已運行一年多的 EPIC 帳戶平均成長速度比非整合帳戶快 2 倍左右。

Among our top 10 accounts, four are now EPIC integrated and we're seeing acceleration in those accounts following integration. In the community setting, this quarter, we achieved a major milestone with the integration of clonoSEQ into Flatiron across 113 community account groups, many of which include multiple practice locations.

在我們的前 10 個帳戶中，現在有 4 個已整合 EPIC，並且我們看到整合後這些帳戶的成長正在加速。在社區環境中，本季度，我們透過將 clonoSEQ 整合到 Flatiron 中，實現了一個重要的里程碑，涵蓋 113 個社區帳戶組，其中許多帳戶組包括多個實踐地點。

This marks a significant advancement in our strategy to scale in the community oncology space. It also provides OncoEMR users with a more streamlined customer experience, enabling simplified ID MRD ordering and the option for serial testing directly through the EMR. Looking ahead, we plan to continue expanding EMR integrations over the coming years, further accelerating adoption, simplifying workflows, reducing order discrepancy, and strengthening our competitive moats.

這標誌著我們在社區腫瘤學領域擴大規模的策略取得了重大進展。它還為 OncoEMR 用戶提供了更簡化的客戶體驗，簡化了 ID MRD 訂購並提供了直接透過 EMR 進行串行測試的選項。展望未來，我們計劃在未來幾年繼續擴大 EMR 集成，進一步加快採用速度，簡化工作流程，減少訂單差異，並加強我們的競爭優勢。

Looking at MRD Pharma on slide 7, our MRD Pharma business had another strong quarter. with revenue up 20% year over year with steady growth in sequencing revenue and $5.5 million in milestones. We ended the quarter with approximately 175 active global clinical trials and a $218 million backlog, up 21% from the prior year. This backlog is a strong leading indicator of future revenue. clonoSEQ is being used as a primary or secondary endpoint in 90 of these studies, many of which may trigger milestone payments upon regulatory approval.

看看幻燈片 7 上的 MRD Pharma，我們的 MRD Pharma 業務又度過了一個強勁的季度，營收年增 20%，定序營收穩定成長，里程碑營收達到 550 萬美元。本季結束時，我們在全球約有 175 項活躍的臨床試驗和 2.18 億美元的積壓訂單，比去年增加 21%。這項積壓訂單是未來營收的強勁領先指標。 clonoSEQ 在其中 90 項研究中被用作主要或次要終點，其中許多研究在獲得監管部門批准後可能會觸發里程碑付款。

On the regulatory front, momentum continues. Recently, the European Medicines Agency CHMP issued a positive opinion supporting the use of MRD testing as an early endpoint for conditional approval in multiple myeloma. This decision aligns with the ODAC recommendation and further cements the already strong case for pharma companies to make MRD a central element of their myeloma drug development strategy. As we continue to monitor developments at the FDA, we're optimistic about the growing global support for MRD to accelerate new treatments, not just in multiple myeloma, but across all lymphoid malignancies.

在監管方面，勢頭持續增強。近日，歐洲藥品管理局CHMP發表了積極意見，支持將MRD檢測作為多發性骨髓瘤有條件批准的早期終點。這項決定符合 ODAC 的建議，並進一步鞏固了製藥公司將 MRD 作為其骨髓瘤藥物開發策略核心要素的有力理由。隨著我們繼續監測 FDA 的發展，我們對全球對 MRD 日益增長的支持感到樂觀，這將加速新的治療方法，不僅適用於多發性骨髓瘤，也適用於所有淋巴系統惡性腫瘤。

Turning to slide 8, I'd like to take a moment to highlight some clonoSEQ MRD data presented this quarter at various conferences. Starting with the MIDAS study in multiple myeloma, this 791-patient study is the first prospective randomized MRD-directed Phase 3 trial to assess the ability of clonoSEQ to guide myeloma transplant decisions.

翻到第 8 張投影片，我想花點時間重點介紹本季在各個會議上展示的一些 clonoSEQ MRD 數據。從多發性骨髓瘤的 MIDAS 研究開始，這項涉及 791 名患者的研究是第一個前瞻性隨機 MRD 指導的 3 期試驗，旨在評估 clonoSEQ 指導骨髓瘤移植決策的能力。

The study evaluated the use of consolidation therapy with versus without transplant in patients who achieved MRD negativity by clonoSEQ at the end of induction. Data shows that patients achieved similar MRD outcomes regardless of whether they received a transplant, supporting the idea that transplant may not be needed for MRD-negative patients.

該研究評估了在誘導結束時透過 clonoSEQ 實現 MRD 陰性的患者中，移植與不移植鞏固治療的使用。數據顯示，無論患者是否接受移植，他們都獲得了相似的 MRD 結果，這支持了 MRD 陰性患者可能不需要移植的觀點。

In CLL, promising interim data from VenetoSTOP, an ongoing Phase 2 study, demonstrated the potential to reduce duration of venetoclax-based therapy in patients who achieve an MRD-negative response. And in DLBCL, several studies presented at the ICML conference in Lugano showed how clonoSEQ and ctDNA can effectively assess response and complement imaging across different lines and classes of therapy.

在 CLL 中，正在進行的 2 期研究 VenetoSTOP 的中期數據顯示，對於獲得 MRD 陰性反應的患者，有可能縮短以維奈克拉為基礎的治療持續時間。對於 DLBCL，在盧加諾舉行的 ICML 會議上提出的幾項研究表明，clonoSEQ 和 ctDNA 如何有效評估不同療法和不同治療類別的反應和補體成像。

Q2 also marked an important milestone for the enhanced version of our clonoSEQ ctDNA assay and DLBCL, as the FDA granted two investigational device exemptions for use in investigator-sponsored trials to assess escalation of therapy for patients who remain MRD positive at the end of frontline treatment. It's exciting to see the expansion of data and studies supporting the interventional use of clonoSEQ, MRD, and lymphoid malignancies to inform clinical decision making, and we look forward to more key data readouts at the ASH conference later this year.

Q2 也標誌著我們 clonoSEQ ctDNA 檢測和 DLBCL 增強版的一個重要里程碑，因為 FDA 授予了兩項研究設備豁免，用於研究者贊助的試驗，以評估在前線治療結束時仍然為 MRD 陽性的患者的治療升級。令人興奮的是，看到越來越多的數據和研究支持介入使用 clonoSEQ、MRD 和淋巴系統惡性腫瘤來為臨床決策提供參考，我們期待在今年稍後的 ASH 會議上看到更多關鍵數據。

In summary, our MRD business is firing on all cylinders. As shown on slide 9, we're only halfway through the year. And most of our key full-year strategic goals have been achieved, including reaching MRD profitability this quarter, ahead of our second-half target. Now let's turn to Immune Medicine on slide 11. Our Immune Medicine business is on track to meet three main goals.

總而言之，我們的 MRD 業務正在全速發展。如投影片 9 所示，今年才過一半。我們大部分關鍵的全年策略目標都已實現，包括本季提前實現 MRD 獲利，提前完成了下半年的目標。現在讓我們翻到第 11 張投影片上的免疫醫學。我們的免疫醫學業務有望實現三個主要目標。

The first goal is to develop a digital TCR antigen prediction model. As we scale the size and quality of our data generation, we aim to replace our validated TCR discovery cellular assays with this digital TCR antigen prediction model, which will significantly reduce both cost and time. We're starting to digitally model the ability to accurately select the best TCRs in our cell therapy application with Genentech.

第一個目標是開發數字 TCR 抗原預測模型。隨著我們數據生成的規模和質量的擴大，我們的目標是用這種數位 TCR 抗原預測模型取代我們經過驗證的 TCR 發現細胞檢測，這將顯著降低成本和時間。我們開始與 Genentech 合作，以數位方式模擬在我們的細胞治療應用中準確選擇最佳 TCR 的能力。

We're also making good progress in applying our large training data sets. This includes improving the accuracy of our TCR-antigen binding predictions and deploying our AI machine learning models to enable additional partnering opportunities with attractive future monetization potential.

我們在應用大型訓練資料集方面也取得了良好的進展。這包括提高我們的 TCR 抗原結合預測的準確性，並部署我們的 AI 機器學習模型，以提供具有誘人未來貨幣化潛力的更多合作機會。

The second goal is to build a robust preclinical data package for our lead T-cell depletion program in autoimmunity. We are conducting functional and biophysical characterization of our top antibody candidates in our lead clinical indication. We also solidified our patient selection strategy in this indication. This will allow us to select only those patients who we confirm have the specific disease-causing autoreactive T-cell receptors and who are at a higher likelihood to respond to our T-cell depletion therapy.

第二個目標是為我們在自體免疫領域的主要 T 細胞耗竭計畫建立一個強大的臨床前資料包。我們正在對主要臨床適應症中的頂級抗體候選物進行功能和生物物理表徵。我們也鞏固了針對此適應症的患者選擇策略。這將使我們能夠僅選擇那些我們確認具有特定致病性自身反應性 T 細胞受體並且更有可能對我們的 T 細胞耗竭療法產生反應的患者。

As we continue to execute on these two focused therapeutic strategies, our third goal is to achieve our 2025 cash burn target of $25 million to $30 million by scaling revenue generation from pharma partnering and continuing to thoughtfully gate R&D investments through year end. Now I'm going to pass it over to Kyle to walk through our financial results and our updated full-year guidance. Kyle?

隨著我們繼續執行這兩項重點治療策略，我們的第三個目標是透過擴大製藥合作的收入並在年底前繼續深思熟慮地控制研發投資，實現 2025 年現金消耗目標 2500 萬至 3000 萬美元。現在我將把麥克風交給凱爾，讓他介紹我們的財務表現和最新的全年指引。凱爾？

Thanks, Chad. Starting on slide 12 with results for the second quarter, total revenue was $58.9 million, representing 36% growth from the same period last year. 85% of the revenue came from the MRD business and 15% from Immune Medicine. MRD revenue grew 42% versus prior year to $49.9 million, with clinical and pharma contributions of 65% and 35% respectively. clonoSEQ test volume, including international, increased 37% to 25,321 tests delivered versus last year.

謝謝，乍得。從第 12 張投影片開始，第二季的業績顯示，總營收為 5,890 萬美元，比去年同期成長 36%。其中 85% 的收入來自 MRD 業務，15% 來自免疫醫學。MRD 收入較上年增長 42%，達到 4,990 萬美元，其中臨床和製藥貢獻分別佔 65% 和 35%。包括國際在內的 clonoSEQ 測試量與去年相比增加了 37%，達到 25,321 次測試。

ASP in the US grew about 17% to [$1,290]. The continued improvement in ASP is mainly driven by our contracting initiatives, improving our pricing and revenue cycle management activities, including aged collections. MRD Pharma revenue grew 20% versus prior year, inclusive of $5.5 million milestones.

美國的平均售價成長約 17%，達到[1,290 美元]。平均售價的持續改善主要得益於我們的承包措施、定價和收入週期管理活動的改善，包括陳舊收款。MRD Pharma 的營收較前一年成長了 20%，其中包括 550 萬美元的里程碑收入。

Immune Medicine revenue was $8.9 million, up 13% from a year ago. Moving down the P&O, sequencing gross margin, which excludes milestones and Genentech amortization, with 64% for the quarter. This represents an improvement of 14 percentage points versus prior year as we continue to leverage lower labor and overhead costs with increasing volumes and higher pricing across both our clinical and pharma revenues.

免疫藥物收入為 890 萬美元，比去年同期成長 13%。降低 P&O，排序毛利率（不包括里程碑和 Genentech 攤銷）本季為 64%。這比去年同期提高了 14 個百分點，因為我們繼續利用較低的勞動力和管理成本，同時增加臨床和製藥收入的數量並提高價格。

Total operating expenses for the quarter, inclusive of cost of revenue, was $83.9 million, representing a 1% increase from last year, excluding the Q2 2024 asset impairment costs. This increase was mainly driven by higher sales and marketing spend attributed to EMR efforts and higher people costs, partially offset by lower cost of revenue and R&D spend.

本季總營運費用（包括收入成本）為 8,390 萬美元，較去年同期成長 1%，但不包括 2024 年第二季資產減損成本。這一增長主要得益於電子病歷 (EMR) 工作帶來的銷售和行銷支出增加以及人力成本上升，但收入成本和研發支出的下降部分抵消了這一增長。

As you can see from the segment reporting table at the bottom of the slide, the MRD business achieved positive adjusted EBITDA of $1.9 million, a massive improvement versus a deficit of $11.3 million a year ago. This is a significant milestone for the business, and we continue to expect positive MRD adjusted EBITDA going forward.

從投影片底部的分部報告表中可以看出，MRD 業務實現了 190 萬美元的正調整後 EBITDA，與去年同期的 1,130 萬美元虧損相比有了巨大的改善。這對公司而言是一個重要的里程碑，我們繼續期待未來 MRD 調整後的 EBITDA 能夠保持正成長。

Immune Medicine adjusted EBITDA loss also improved 14% versus Q2 of last year. Total company adjusted EBITDA was a loss of $7.2 million in the second quarter compared to a $21.4 million loss in the prior year. Interest expense from a royalty financing agreement with OrbiMed was $2.9 million, which was slightly higher than interest income. Net loss for the quarter was $25.6 million.

免疫醫學調整後的 EBITDA 虧損也比去年第二季改善了 14%。第二季公司調整後的 EBITDA 總虧損 720 萬美元，去年同期的虧損為 2,140 萬美元。與 OrbiMed 簽訂的特許權融資協議的利息支出為 290 萬美元，略高於利息收入。本季淨虧損為 2,560 萬美元。

Now let's turn to our full-year 2025 updated guidance on slide 13. We are again raising our full year MRD revenue guidance to a range of $190 million to $200 million, up from our previous range of $180 million to $190 million. This increase is driven by stronger-than-expected clinical volume performance in the second quarter and higher MRD milestone revenue anticipated for the year.

現在讓我們來看看第 13 張投影片上的 2025 年全年更新指南。我們再次將全年 MRD 收入預期從先前的 1.8 億至 1.9 億美元上調至 1.9 億至 2 億美元。這一增長是由於第二季度臨床表現強於預期以及預計今年 MRD 里程碑收入將增加。

Given the strong clonoSEQ test volumes in the quarter and the momentum we are seeing, we now expect approximately 35% growth in fiscal year 2025 volumes versus 2024. And we anticipate sequential growth in both the third and fourth quarters. We also expect revenue from MRD milestones to be between $14 million and $15 million, up from our previous guidance of $8 million to $9 million.

鑑於本季 clonoSEQ 測試量強勁以及我們看到的勢頭，我們現在預計 2025 財年測試量將比 2024 年增長約 35%。我們預計第三季和第四季都將實現連續成長。我們也預期 MRD 里程碑的營收將在 1,400 萬美元至 1,500 萬美元之間，高於我們先前預測的 800 萬美元至 900 萬美元。

This updated MRD revenue guide represents significant growth of 31% to 37% versus fiscal year 2024, and 32% to 39% for the MRD-based business, which excludes MRD milestones at the midpoint. We are reiterating our full-year total company operating expense guidance, including cost of revenue, to be between $335 million and $345 million. We continue to expect approximately 69% of this to be driven by the MRD business and 23% from Immune Medicine, with the remainder attributed to unallocated corporate costs.

更新後的 MRD 營收指南顯示，與 2024 財年相比，MRD 營收將大幅成長 31% 至 37%，而基於 MRD 的業務（不包括中點的 MRD 里程碑）將成長 32% 至 39%。我們重申全年公司總營運費用指引（包括收入成本）在 3.35 億美元至 3.45 億美元之間。我們仍預期其中約 69% 來自 MRD 業務，23% 來自免疫醫學，其餘則歸因於未分配的公司成本。

Lastly, we are lowering our full-year total company cash burden guidance to a range of $45 million to $55 million, down from the prior range of $50 million to $60 million. This improvement is primarily driven by the higher-than-expected MRD revenue. We now expect approximately 18% of this year's cash burn to come from the MRD business and still anticipate burn from Immune Medicine to be between $25 million and $30 million, with the remainder attributed to unallocated corporate costs.

最後，我們將全年公司總現金負擔預期從先前的 5,000 萬至 6,000 萬美元下調至 4,500 萬至 5,500 萬美元。這項改善主要得益於高於預期的 MRD 收入。我們現在預計今年約 18% 的現金消耗來自 MRD 業務，並且仍預計免疫醫學業務的消耗將在 2500 萬美元至 3000 萬美元之間，其餘部分歸因於未分配的公司成本。

The strong financial performance of the first half of the year has set up the MRD business to achieve recurring adjusted EBITDA profitability and a clear pathway to cash breakeven in the near term. Across the business, we will remain focused on this disciplined execution to drive continued sustainable growth while managing our investments appropriately.

今年上半年強勁的財務表現為 MRD 業務實現了經常性調整後 EBITDA 盈利，並在短期內實現了現金收支平衡。在整個業務中，我們將繼續專注於這種嚴格的執行，以推動持續的可持續成長，同時適當地管理我們的投資。

With that, I'll hand it back over to Chad.

說完這些，我就把權力交還給查德。

Thanks, Kyle. Our second-quarter results are a clear testament to our disciplined execution and strategic focus across every part of the business. Achieving positive adjusted EBITDA in our MRD business marks a major milestone, one that reflects the strength of our model and the commitment of our team. We're confident in delivering on our raised four-year guidance remain focused on execution with the discipline, urgency, and precision needed to deliver on our goals and create long-term value for our patients, our partners, and our shareholders.

謝謝，凱爾。我們第二季的業績清楚地證明了我們在業務各個部分的嚴格執行和策略重點。在我們的 MRD 業務中實現正調整後 EBITDA 標誌著一個重要的里程碑，它反映了我們模式的實力和我們團隊的承諾。我們有信心實現我們提出的四年指導方針，繼續專注於執行，以必要的紀律性、緊迫性和精確性來實現我們的目標，並為我們的患者、合作夥伴和股東創造長期價值。

With that, I'd like to now turn the call back over to the operator and open it up for questions.

現在，我想將電話轉回給接線員，並開始回答問題。

(Operator Instruction) Dan Brennan, TD Securities.

（操作員指示） 道明證券的 Dan Brennan。

Terrific. Thank you. Thanks for the questions and nice quarter, obviously. Maybe the first one just on the volume side, really strong volume. Chad, you called out a lot of the vignettes about the success and the impact of EPIC. I just wonder if you could speak a little bit on Flatiron. Obviously, you just did the roll out now. It's pretty massive.

了不起。謝謝。顯然，感謝您的提問，這是一個愉快的季度。也許第一個只是在音量方面，音量真的很大。查德，你列舉了很多有關 EPIC 的成功和影響的例子。我只是想知道您是否可以談談 Flatiron。顯然，您剛剛完成了推出。它相當龐大。

Are there any early kind of things to note on what you're seeing so far? And can you just remind us how you're thinking about the volume growth guide that you've given for the back half of the year and how we might think about the benefits of the new accounts on Flatiron and kind of how those might flow through in terms of volume strength.

就您目前所見，有什麼早期的事情需要注意嗎？您能否提醒我們，您如何看待您給出的下半年交易量成長指南，以及我們如何看待 Flatiron 新帳戶帶來的好處，以及這些好處在交易量強度方面將如何體現。

Sure, Dan. Thanks for the question. I'm going to have Susan kind of jump in with some details on Flatiron.

當然，丹。謝謝你的提問。我將讓蘇珊 (Susan) 詳細介紹 Flatiron。

Sure. Hi, Dan. So as you know, we went live nationally with OncoEMR on July 1, so we are in very early days of the integration. And remember, many of the OncoEMR accounts are accounts where we have little or no existing business. So this integration does represent a significant opportunity to expand in the community. Prior to the integration, these accounts made up about 6% of our total volume, about 20% of our community volume.

當然。你好，丹。如您所知，我們於 7 月 1 日在全國範圍內與 OncoEMR 合作，因此我們正處於整合的早期階段。請記住，許多 OncoEMR 帳戶都是我們目前沒有或很少有業務的帳戶。因此，這種整合確實代表著社區擴張的重要機會。在整合之前，這些帳戶約占我們總交易量的 6%，約占我們社區交易量的 20%。

We're very pleased with the initial results we are seeing, albeit it is very early, both in terms of the volume and the workflow. And we're receiving resoundingly positive feedback from our customers. We are also observing that a majority of the ordering HTPs at these accounts are opting to use the serial monitoring feature that Chad alluded to in his earlier remarks.

儘管從數量和工作流程來看還為時過早，但我們對所看到的初步結果感到非常滿意。我們收到了來自客戶的非常正面的回饋。我們還觀察到，這些帳戶的大多數訂購 HTP 都選擇使用 Chad 在先前評論中提到的串行監控功能。

And that's a new feature of our ordering process that's currently unique to OncoEMR, and we do expect that it will support more consistent ordering at clinically appropriate time points in the community. Now we did build the Flatiron launch into our guide as a growth driver, both for Q3 and Q4. But I do think there's potential for upside. We'll continue to gain insight into exactly what the pace and degree of acceleration that we can expect from this is as we gain a little bit more experience.

這是我們訂購流程的新功能，目前是 OncoEMR 獨有的，我們確實希望它能夠在社區中臨床適當的時間點支援更一致的訂購。現在，我們確實將 Flatiron 的發布納入我們的指南中，作為第三季和第四季的成長動力。但我確實認為還有上漲的潛力。隨著我們獲得更多經驗，我們將繼續深入了解我們可以預期的速度和加速程度。

Terrific. Yes, there'd be a lot to unpack on that, which we can do later. Maybe just on the pricing side, that's a second follow up there in terms of pricing came in. Nice success there. I know you mentioned, I guess, contracting and things. Could you unpack a little bit about what you saw on clonoSEQ pricing. I read the full-year guide. It seems like you have a lot of momentum there. I'm just wondering, across different payer types, where are you seeing the biggest traction and kind of what are you assuming for the back half of the year, which arguably could be conservative?

了不起。是的，這方面有很多事情需要解決，我們可以稍後再做。也許只是在定價方面，這是對定價的第二次跟進。那裡很成功。我知道您提到過承包之類的事情。您能否稍微解釋一下您對 clonoSEQ 定價的看法？我讀了全年指南。看起來你在那裡有很大的動力。我只是想知道，在不同的付款人類型中，您認為哪裡的吸引力最大，以及您對今年下半年的預測可能是保守的嗎？

Yes, thanks for the question, Dan. This is Kyle. On the pricing improvement, I mean, I think we're gaining kind of the growth from the contracting efforts we implemented in the back half of last year, and we're starting to see that pull through across a number of the Blue Cross payers. Medicare, just a percentage of mix is mixing to the newer price point. And so we're seeing those effects.

是的，謝謝你的提問，丹。這是凱爾。關於價格改善，我的意思是，我認為我們從去年下半年實施的合約努力中獲得了某種增長，並且我們開始看到這種增長在眾多藍十字付款人中得到體現。醫療保險，只有一小部分混合到了較新的價格點。所以我們看到了這些影響。

But as we look forward to the second half of the year, a number of our larger contracting implementations with the larger national payers come into play, so I think we're well set up into the second half of the year to continue to see some improvement. We did have some initial wins. It's a little early to say if it's going to kind of continue at this rate with California and Medicaid as well in the second quarter, so that's giving us some momentum heading into the back half of the year.

但當我們展望下半年時，我們與較大的國家付款人簽訂的許多較大的合約將開始發揮作用，所以我認為我們已經為下半年做好了準備，並將繼續看到一些改善。我們確實取得了一些初步勝利。現在判斷加州和醫療補助計劃第二季度是否會繼續以這種速度發展還為時過早，但這為我們進入下半年提供了一些動力。

If I can just take one more in. Just on the EBITDA side, really nice traction in the quarter. How do we think about, as we look ahead, and you're balancing investments in the business versus really seeing some of this EBITDA margin potential flow through. How might we think about kind of where you can end the year and what that means as we look ahead to '26 on the MRD side? Thank you.

如果我能再接受一個就好了。僅從 EBITDA 方面來看，本季的勢頭確實很好。展望未來，我們如何思考，您要平衡業務投資與真正看到部分 EBITDA 利潤潛力流入。當我們展望 26 年 MRD 方面時，我們如何思考如何結束這一年以及這意味著什麼？謝謝。

Kyle, you start on just in terms of numbers, and then I'll provide commentary there.

凱爾，你先從數字開始，然後我會提供評論。

Yes, a great milestone for the business to achieve positive adjusted EBITDA. I think, in terms of back half of the year, we are set up with the right trajectory to continue to repeat adjusted EBITDA profitability. And in terms of the magnitude of that, some of that will vary, depending on the timing of milestones, et cetera. But we're thinking about this as the business is set up to kind of continuously produce positive adjusted EBITDA, and we're seeing that for the longer term here.

是的，實現正向調整後 EBITDA 對企業來說是一個重要的里程碑。我認為，就今年下半年而言，我們已經設定了正確的軌跡，將繼續重複調整後的 EBITDA 獲利能力。就其規模而言，有些會有所不同，取決於里程碑的時間等等。但我們正在考慮這一點，因為業務的設定是為了持續產生正的調整後 EBITDA，而且我們預計這種情況將持續較長時間。

Yes, and Dan, I would say this. For the MRD business, we're seeing, as evidenced by the last several quarters, a really nice acceleration. But we're still in the very early innings. And there's a kind of a long growth trajectory ahead of us in blood-based testing in the community setting, additional data generation. So we'll continue to make investments in the MRD business.

是的，丹，我會這麼說。對於 MRD 業務，我們看到，正如過去幾個季度所證明的那樣，出現了非常好的加速成長。但我們仍處於非常早期的階段。在社區環境中進行血液檢測並產生更多數據方面，我們還有很長的發展道路。因此我們將繼續對 MRD 業務進行投資。

And then kind of in the medium term, obviously, there's international markets to explore additional capital allocations towards -- and potentially additional tests and kind of blood-based measures to support the MRD business. As we look forward, we'll kind of balance out our capital allocation and kind of investments going forward for our growth trajectory.

然後，從中期來看，顯然，我們可以在國際市場上探索額外的資本配置，並可能透過額外的測試和基於血液的措施來支持 MRD 業務。展望未來，我們將平衡資本配置和投資，以實現我們的成長軌跡。

Great, okay. Thank you very much.

太好了，好的。非常感謝。

Andrew Brackmann, William Blair.

安德魯布拉克曼、威廉布萊爾。

Great. Hi, everyone. Good afternoon. Thanks for taking the question. Chad, maybe around your commentary around expanding the footprint into the community channel, Flatiron's obviously a major level there, but maybe just sort of talk about some of the other drivers there which should help you drive growth here, not just in the second half, but even longer term, be that expanding indications or blood as a sample type. Thanks.

偉大的。大家好。午安.感謝您回答這個問題。查德，也許圍繞著你關於擴大社區管道影響力的評論，Flatiron 顯然是一個重要的水平，但也許只是談論一些其他的驅動因素，這些因素應該可以幫助你推動這裡的增長，不僅是在下半年，甚至是更長遠的時期，無論是擴大適應症還是血液作為樣本類型。謝謝。

Yes. One of the things that we highlighted in our prepared remarks was the NeoGenomics collaboration. And we're excited about that because they're in -- 60% of the accounts that they're in, we're not in at all yet. So that's a really nice opportunity for us to increase our penetration. Susan, do you want to comment on some other efforts that we're doing in the community in terms of putting together pathways, et cetera?

是的。我們在準備好的演講中強調的事情之一是 NeoGenomics 合作。我們對此感到很興奮，因為他們的帳戶中有 60% 是我們尚未進入的。所以這對我們來說是一個提高滲透率的好機會。蘇珊，你想評論一下我們在社區中所做的其他一些努力，例如修建道路等等嗎？

Happy to. Yes, Andrew, a couple of other things that are consistent in our strategy, one is a continued focus on the large national strategic accounts, these oncology practice networks that control a large proportion of the cancer patients in the community settings.

很開心。是的，安德魯，我們的策略中還有其他一些一致之處，一是繼續關注大型國家戰略帳戶，這些腫瘤學實踐網絡控制著社區環境中很大一部分癌症患者。

So those, we have a separate sales team that focuses specifically on top-down strategy, engaging with the C-suite, et cetera, to ensure that we have unified direction from their leadership and policies that we can advance that can be consistent across the entire network. The other key thing is engaging academic thought leaders to help us drive community adoption. They have the credibility with those providers. They have the referral networks that they can use to leverage their influence.

因此，我們有一個單獨的銷售團隊，專門負責自上而下的戰略，與高管層等進行接觸，以確保我們從他們的領導層獲得統一的方向和可以推進的政策，並且這些政策可以在整個網絡中保持一致。另一個關鍵因素是吸引學術思想領袖來幫助我們推動社區的採用。他們在這些供應商中享有盛譽。他們擁有可利用的推薦網絡來擴大自己的影響力。

And therefore, we've increasingly -- and particularly in light of the recent NCCN guideline update with multiple myeloma, we've been leveraging our thought leaders and partnering with them to deliver education to the community on things like why it's important to perform an ID test at the time of diagnosis. So in combination with our EMR strategy and our collaboration with NEO, those are some of the key things that are consistent in our community strategy. And you mentioned blood. That will always be a part of the conversation and a key adoption driver for community clinics.

因此，我們越來越多地——特別是考慮到最近 NCCN 對多發性骨髓瘤的指南更新，我們一直在利用我們的思想領袖並與他們合作，向社區提供教育，例如為什麼在診斷時進行 ID 測試很重要。因此，結合我們的 EMR 策略以及與 NEO 的合作，這些是我們社區策略中保持一致的一些關鍵事項。您還提到了血液。這將永遠是討論的一部分，也是社區診所採用的關鍵驅動力。

Great. Thanks. And then as a follow up here, Chad, just want to follow up to some of the comments you made to Dan's last question around sort of additional investments here. clonoSEQ clearly has a long growth ahead of it, but as you sort of think about adding menu here some other labs are trying to become more of a one-stop shop. What are some of the key sort of characteristics that you might consider as you're thinking about bringing on additional tests? Thanks.

偉大的。謝謝。然後作為後續問題，Chad，我只想跟進一下你對 Dan 的最後一個問題所做的一些評論，關於這裡的額外投資。 clonoSEQ 顯然還有很長的路要走，但是當你考慮在這裡添加菜單時，其他一些實驗室正試圖成為一站式商店。當您考慮進行額外測試時，您可能會考慮哪些關鍵特徵？謝謝。

Yes, I mean, I look at it in two ways. One is kind of brand, and the other is channel. So how do you leverage your brand in MRD is one thing I look at, and then secondly is how do we leverage a really superior channel that we've built in the heme-onc space? So I would say those are the broad-based tests. That's kind of a broad-based from an MRD perspective.

是的，我的意思是，我從兩個角度看待這個問題。一個是品牌類型，一個是通路。因此，我要考慮的一件事是，如何在 MRD 中利用您的品牌，其次是，我們如何利用我們在血液腫瘤領域建立的真正優質的管道？所以我想說這些都是廣泛的測試。從 MRD 角度來看，這是一個廣泛的觀點。

And then secondarily, I look at what is the infrastructure we've built to be able to both validate, support diagnostics more broadly. And again, as you know, we've been putting together, for example, this TCR-antigen prediction model. It could have some kind of future applications within the diagnostic channels, again, early on, but these are the things that we continue to explore.

其次，我會看看我們建造了什麼樣的基礎設施，以便能夠更廣泛地驗證和支援診斷。再說一次，如您所知，我們一直在整合這個 TCR 抗原預測模型。它可能在診斷管道中具有某種未來的應用，同樣，在早期，但這些都是我們繼續探索的東西。

Great. Thanks, guys.

偉大的。謝謝大家。

David Westenberg, Piper Sandler. Please go ahead.

大衛‧韋斯滕伯格、派珀‧桑德勒。請繼續。

Hey, thanks for taking the question. I actually wanted to tack on for Dan's question on profitability. And again, congrats on the profitability in the MRD business. But you also implied cash flow positive on a go-forward basis. Given the factors in terms of fluctuations in milestone payments and whatnot, do you have visibility on what the milestone payments look like maybe this quarter and next? And if you don't get me in the next couple of quarters, is there a chance for you to go below? And essentially what I'm laying out with this question is the ability for you to not be held to a certain number if there is indeed milestones or not milestones.

嘿，謝謝你回答這個問題。我實際上想回答丹關於盈利能力的問題。再次恭喜 MRD 業務獲利。但您也暗示未來現金流將為正值。考慮到里程碑付款波動等因素，您是否可以預測本季和下一季的里程碑付款？如果你在接下來的幾個季度裡沒有得到我，你還有機會進入前十名嗎？本質上，我提出這個問題的意思是，無論是否確實有里程碑，你都可以不受某個數字的限制。

Yes, thanks, David. This is Kyle. As it relates to the back half of the year, we implied in our guide that there's about $4 million to $5 million to go in the back half of the year as we have $10 million altogether. So again, yes, could those be lumpy in a quarter-by-quarter basis? Certainly. I think -- as I think about cash flow positivity and where the business trajectory is headed, I'm trying to think about that on an annualized basis.

是的，謝謝，大衛。這是凱爾。至於下半年，我們在指南中暗示，由於我們總共有 1000 萬美元，因此下半年大約需要花費 400 萬至 500 萬美元。那麼，是的，這些數字按季度來看會不會不均勻呢？當然。我認為——當我考慮現金流的正向性和業務發展軌跡時，我會嘗試以年度化的方式來考慮這個問題。

Just given to quarter, we can have variability in spend, investment, et cetera. But I think what we're set up to do is to continue to deliver that with the trajectory of the clinical business and the volume growth we're seeing there, strong performance in the pharma business as well. So I think we're not exactly there yet, but with NovaSeq coming online, the trajectory of the business set up to kind of deliver that in the near term.

僅就季度而言，我們的支出、投資等可能會有所不同。但我認為，我們要做的是繼續實現這一目標，隨著臨床業務的發展軌跡和我們看到的銷售成長，以及製藥業務的強勁表現。所以我認為我們還沒有完全實現這一目標，但隨著 NovaSeq 的上線，業務的發展軌跡將在短期內實現這一目標。

Appreciate that. And then I just want to talk about the clonoSEQ volumes. I mean, we're really seeing kind of an acceleration, 37% year-over-year growth. You're already at a higher base, and you got 10% sequentially. So obviously, things are going really well there. Can you rank order some of the factors in terms of what's been driving the volume increases? I mean, I'm guessing a lot of this has been the integrations, but if there's anything we're missing in terms of new indications, for instance, DLBCL or anything like that.

非常感謝。然後我只想談談 clonoSEQ 卷。我的意思是，我們確實看到了一種加速，比去年同期成長 37%。你已經處於更高的基數，並且連續獲得了 10%。顯然，那裡的情況進展非常順利。您能否根據推動銷售成長的一些因素進行排序？我的意思是，我猜其中很多都是整合，但如果我們在新的適應症方面缺少什麼，例如 DLBCL 或類似的東西。

And if you can give us kind of a flavor for how these integrations go and how that kind of -- how you see volumes trickling out over the next quarters or so. I think you've mentioned you had double the amount of volume in -- or double the amount of volume growth in EPIC integrated versus non-EPIC integrated or if it was Flatiron.

如果您能為我們介紹這些整合的進展情況，以及您認為未來幾季整合量將如何成長。我想您提到過，與非 EPIC 整合或 Flatiron 相比，EPIC 整合的交易量增加了一倍 - 或者說交易量成長率增加了一倍。

Does that expect it -- do you expect to see a tail there for a number of years? And sorry to make this really long, but can you clarify the ordering -- the integration where you have multiple orders with specific timing. And I just want to basically clarify on that. Do you ever get timing, or did you ever get more than four tests ordering -- ordered on that. Hopefully that was clear. That was a lot. Thank you.

您預計這種情況會持續幾年嗎？很抱歉寫得這麼長，但是您能否澄清一下排序——即您有多個具有特定時間的訂單的整合。我只是想就此作出基本澄清。您是否曾經掌握時間，或者您是否曾經進行過超過四次的測試排序 — — 排序過。希望這已經很清楚了。太多了。謝謝。

Let me see -- yes, let me see if I can take those, at least the first couple one by one. So in terms of the volume growth, as you noted, we've seen a number of -- we've had -- we've anticipated that there could be upside, and we've seen that upside realized in Q2. And I think we'll have a -- we'll take advantage of the EMR integrations on an ongoing basis.

讓我看看——是的，讓我看看我是否可以把這些，至少是前幾個逐一拿下來。因此，就銷售成長而言，正如您所說，我們已經看到了一些——我們已經——我們預計可能會有上行空間，並且我們已經看到這種上行空間在第二季度實現。我認為我們將會持續利用 EMR 整合的優勢。

I think some of the other things in Q2 that were important were, first of all, continued strong growth in mantle cell lymphoma, which we recently launched, as you know; as well as in diffuse large B cell lymphoma, which is one of our newer indications and one for which the data continues to build and the sort of clinical use case continues to be, I think, made more clear.

我認為第二季度其他一些重要的事情是，首先，套細胞淋巴瘤的持續強勁增長，正如你所知，這是我們最近推出的；以及瀰漫大 B 細胞淋巴瘤，這是我們較新的適應症之一，其數據不斷積累，我認為臨床用例的類型也在不斷明確。

We also had the tailwinds of the NCCN guidelines updates. We continue to see very strong support globally for MRD in pharma, which has synergies and spillover to the clinical setting. So our blood testing increased overall. Our blood testing increased in multiple myeloma. I think all the things that we're doing are all sort of delivering and contributing to the growth. So it's not just one thing. And that will continue to be the story going forward.

我們也得到了 NCCN 指南更新的推動。我們繼續看到全球對製藥業 MRD 的大力支持，這對臨床環境具有協同效應和外溢效應。因此我們的血液檢測總體上有所增加。我們的血液檢測顯示多發性骨髓瘤的發生率增加。我認為我們所做的一切都是為了促進成長。所以這不只是一件事。而這將會是未來故事的延續。

With regard to integrations, we did see a significant increase in the pace of integrations through EPIC that we were able to deliver in Q2. Thirteen a quarter was the most we've done, and we've doubled the number that we've completed in the last six months. We went from 20 to 40 in six months. It's certainly on the account side.

關於集成，我們確實看到透過 EPIC 實現的集成速度顯著加快，並且我們能夠在第二季度實現集成。每季我們最多完成了 13 項，而過去六個月我們完成的數量是之前的兩倍。我們在六個月內從 20 人增加到了 40 人。這肯定是在帳戶方面。

There are many dependencies that we have on our accounts to complete those integrations, so it's difficult to predict the pace going forward. But we do feel confident that we're on track for our goal of about 50% of our volume going through an integration, either EPIC or otherwise, by the end of the year. I do think that eventually integrations will slow down, but we are not there yet.

為了完成這些整合，我們對帳戶有很多依賴，因此很難預測未來的速度。但我們確實有信心，我們有望實現我們的目標，即到今年年底，大約 50% 的業務量將透過 EPIC 或其他方式進行整合。我確實認為整合最終會放緩，但我們還沒有到達那一步。

We have more ahead of us than we have behind us and much more opportunity to optimize the integrations that are already in place so that we can see even better differentiation of the growth in those accounts versus the non-integrated accounts. And then lastly, I think you asked about the episode. Kyle, I don't know if you want to take that one or if you'd like me to.

我們面前還有更多的事要做，也有更多的機會來優化已經存在的整合，以便我們能夠更好地區分這些帳戶和非整合帳戶的成長。最後，我想您問的是有關這一集的事情。凱爾，我不知道你是否想接受這個或你是否希望我接受。

Yes. David and Susan, feel free to chime in. From an ordering perspective, clinicians are still ordering test by test. Effectively, they can, in certain integrations, place reminders for future orders. But really, we're just paid a bundle for Medicare, and that's specific to the Medicare coverage, the Medicare line of business. So if we get an eligible test for Medicare, that is paid once for the effective four tests.

是的。大衛和蘇珊，請隨意發表意見。從排序角度來看，臨床醫師仍在逐次測試排序。實際上，他們可以在某些整合中為未來的訂單設定提醒。但實際上，我們只是為醫療保險支付了一大筆錢，這是醫療保險覆蓋範圍和醫療保險業務線所特有的。因此，如果我們接受了符合醫療保險條件的測試，則只需為有效的四次測試支付一次費用。

David, I think you were asking specifically about serial testing and as it relates to the logistics of our integrations. One of the unique features that we've done for the first time in the Flatiron OncoEMR system, the actual default is you can order a number of tests, so it's kind of three, six, nine tests as a -- sorry, on a recurring basis of three months, six months, nine months, every 12 months, or every time a patient comes in.

大衛，我認為您具體詢問的是串行測試以及它與我們集成的物流的關係。我們在 Flatiron OncoEMR 系統中首次實現的獨特功能之一是，實際預設設定是您可以訂購多項測試，因此可以進行三項、六項、九項測試 - 抱歉，可以每三個月、六個月、九個月、每 12 個月或每次患者來診時重複進行。

Or you can say I want to order on a test-by-test basis. And I'm not going to give you statistics. I'll just say it's kind of early, but we've seen a very nice uptake in clinicians that have clicked on a button to order on a cadence of a monthly three-, six-, nine-, or 12-month cadence. And so that's what we're talking about in terms of the excitement around repeat ordering and the functionality that we can build into these AMR systems.

或者您可以說我想根據每個測試進行排序。我不會給你提供統計數據。我只能說現在還為時過早，但我們已經看到臨床醫生的接受度非常高，他們點擊按鈕即可按照每月三、六個月、九個月或十二個月的節奏進行訂購。這就是我們所談論的關於重複訂購的興奮之處以及我們可以在這些 AMR 系統中建立的功能。

I got a long question there, so sorry about that. Congrats again. Thank you.

我有一個很長的問題，對此我很抱歉。再次恭喜。謝謝。

Thanks, David.

謝謝，大衛。

Mark Massaro, BTIG.

BTIG 的馬克馬薩羅。

Hey, guys. Congrats on a strong quarter. I have a few questions on the EMR integrations. Looks like everything's going well. So you've got 40 on EPIC; 13 were in Q2. So it looks like you had 27 heading into Q2. Would you define those 27 prior to this quarter as the mature integrated sites? And the reason I ask is I'm trying to get a feel for how long it takes you to get to a degree of maturity such that you're seeing, call it, 2x growing twice as fast within mature EPIC integration.

嘿，大家好。恭喜本季業績強勁。我對 EMR 整合有幾個疑問。看起來一切都很順利。因此，EPIC 上有 40 個；其中 13 個在第二季。因此看起來您進入 Q2 時已經有 27 個了。您是否將本季之前的 27 個站點定義為成熟的綜合站點？我之所以問這個問題，是想了解你們需要多長時間才能達到一定的成熟度，以至於你們可以看到，在成熟的 EPIC 整合中，成長速度是原來的兩倍。

And then I also wanted to ask about Flatiron. I recognize that that was a lot of sites all at once over a hundred sites. Effectively, was that just pushing a button overnight? And then do you have a sense for -- or do you have enough data that the Flatiron could see similar pull through to the mature EPIC sites?

然後我還想問 Flatiron。我體認到，這是一個很大的網站，一下子就超過一百個網站了。實際上，這只是一夜之間按下按鈕而已嗎？那麼，您是否有一種感覺——或者您是否有足夠的數據，可以讓 Flatiron 對成熟的 EPIC 站點產生類似的影響？

I think I can take those questions, Mark. So first on EPIC, we're defining mature sites as those that have been live for at least a year, so not all of those 27. In fact, it's more like six at this point. And we are looking at those specifically because we wanted to understand if the early impact that we're seeing immediately post-integration, which is generally pretty significant, can be sustained. So in fact, if I were to talk about the impact in the three months post-integration, there's usually a larger impact.

我想我可以回答這些問題，馬克。首先，在 EPIC 上，我們將成熟站點定義為已運行至少一年的站點，因此並非所有這 27 個站點。事實上，現在更像是六個。我們特別關注這些問題，因為我們想了解整合後立即看到的早期影響（通常相當顯著）是否能夠持續下去。所以事實上，如果我要談整合後三個月的影響，通常影響會更大。

But over time, we wanted to see what that looked like, and we do see a consistent pace of increased growth. But it's still because we've been doing this for about 18 months. And we have a smaller group that we started with that has been live for at least a year, including a number of smaller accounts. Frankly, there are the mostly smaller accounts in that in that initial group. We'll have to continue to learn more as we gain more data. But six months from now, we'll have a much larger group. We'll have about 20 that have been live for a year.

但隨著時間的推移，我們想看看它會是什麼樣子，而我們確實看到了持續成長的速度。但這仍然是因為我們已經這樣做了大約 18 個月。我們最初有一個較小的團隊，該團隊已經活躍了至少一年，其中包括一些較小的帳戶。坦白說，最初的那群人中大多數都是小帳戶。隨著我們獲得更多數據，我們必須繼續學習更多知識。但六個月後，我們的群體將變得更大。我們有大約 20 個已經運行了一年。

Okay. That's really helpful. So my second question is on the (multiple speakers) Sorry. Go ahead.

好的。這真的很有幫助。我的第二個問題是關於（多位發言者）抱歉。前進。

I'm sorry. Did you want me to go ahead on the Flatiron one? Sorry, I didn't --

對不起。你想讓我繼續進行 Flatiron 嗎？抱歉，我沒有--

Of course. Keep going. Yes, thanks.

當然。繼續前進。是的，謝謝。

Sorry. You're correct that Flatiron was essentially pushing a button. On July 1, all of those 113 account groups went live. We actually did a small pilot with four of them prior, but all of the rest went live on July 1. And it's, I think, too early to say whether we can anticipate similar patterns, but I will point back to what Chad was talking about, the serial testing option, which is easier to use in Flatiron's OncoEMR than it is to use a similar feature like standing orders in EPIC.

對不起。您說得對，Flatiron 本質上就是按下了一個按鈕。7月1日，這113個帳號組全部上線。實際上，我們之前曾與其中四個進行過小規模試點，但其餘的都於 7 月 1 日上線。我認為現在說我們是否可以預測類似的模式還為時過早，但我將回顧 Chad 所談論的內容，即連續測試選項，它在 Flatiron 的 OncoEMR 中比使用 EPIC 中的類似功能（如常備訂單）更容易使用。

At least it's easier for us to have visibility into it. and it's easier to schedule the patient. And so we do anticipate that we'll have a better ability to follow through on serial orders and help support clinicians in delivering appropriate testing frequency with Flatiron. So I do see some upside there, but it's very early to speculate beyond that.

至少我們可以更輕鬆地了解它，並且更容易安排病人。因此，我們確實預計我們將有更好的能力執行連續訂單，並幫助支援臨床醫生使用 Flatiron 提供適當的測試頻率。所以我確實看到了一些好處，但現在猜測還為時過早。

Okay, thanks so much for that. And then my last question, I wanted to better understand the NEO collaboration. So it looks like you launched Phase 1. Chad, or maybe someone else on the team, can you expand on what Phase 1 consists of, and then what would Phase 2 be?

好的，非常感謝。我的最後一個問題是，我想更了解 NEO 合作。看起來你已經啟動第一階段了。查德，或是團隊中的其他人，您能否詳細說明第一階段包含哪些內容，第二階段又是什麼？

And then I recognize this is a commercial partnership, so my understanding is that there's going to be NEO reps going out selling clonoSEQ to many of their customers. Just give us a sense for what type of lift we might be able to see. And I imagine this is more of a 2026 impact, but should we expect any impact in the second half of '26 -- or excuse me, second half of '25.

然後我意識到這是一種商業合作關係，所以我的理解是 NEO 代表將會向他們的許多客戶銷售 clonoSEQ。只需讓我們了解一下我們可能看到的升力類型即可。我認為這更多的是 2026 年的影響，但我們是否應該預期在 2026 年下半年——或者對不起，2025 年下半年——會產生影響。

Sure, so Phase 1 is our pilot effort with a very small handful of small accounts, again, with the intent of ensuring that we've worked through all the operational processes, the collaboration, and handoffs between the two companies with accounts that are willing to do the process in a fairly manual manner. So it's really intended for us to learn and gather insights both from the customer and from our own processes as opposed to generate any material impact on volumes.

當然，第一階段是我們的試點項目，只針對極少數小帳戶，同樣，我們的目的是確保我們已經完成了所有營運流程、協作以及兩家公司之間的交接，並且這些帳戶願意以相當手動的方式完成流程。因此，這實際上是為了讓我們從客戶和我們自己的流程中學習和收集見解，而不是對產量產生任何實質的影響。

And I would extend that expectation through the remainder of 2025. We do have the plan to bring on additional accounts during the course of the second half of this year. But I don't anticipate material impacts to our volumes beyond what we've already guided. 2026 and 2027 is where we will see that material lift when we launch nationally in the early part of next year.

我將把這項預期延續到 2025 年剩餘時間。我們確實計劃在今年下半年增加更多帳戶。但我預計，超出我們既定目標的實質影響不會對我們的銷售產生影響。 2026 年和 2027 年，當我們在明年年初在全國範圍內推出該產品時，我們將看到這種實質性的提升。

And just one clarification, Mark, when you kind of mentioned that NEO reps are going out and selling clonoSEQ tests. And I want to just be clear on how that works. They're going out and selling a COMPASS panel that will include, as part of a battery of ID tests done at diagnosis, that will include the ID clonoSEQ test as part of the COMPASS workup.

馬克，當您提到 NEO 代表正在出去銷售 clonoSEQ 測試時，我只想澄清一點。我只是想清楚地說明這是如何運作的。他們正在出售 COMPASS 面板，該面板將包括在診斷時進行的一系列 ID 測試的一部分，其中包括 ID clonoSEQ 測試作為 COMPASS 檢查的一部分。

And then, effectively, they're selling the COMPASS workup with MRD kind of baked in. And then, secondly, as part of kind of their recurrence monitoring or their monitoring across the patient lifecycle, they have an offering called CHART. And they'll be selling, effectively, clonoSEQ embedded into the CHART offering as the clonoSEQ MRD test.

然後，他們實際上正在銷售內建 MRD 的 COMPASS 檢查產品。其次，作為復發監測或患者生命週期監測的一部分，他們提供了一項名為 CHART 的服務。他們將有效地將 clonoSEQ 嵌入到 CHART 產品中作為 clonoSEQ MRD 測試進行銷售。

Great. Thanks so much, guys.

偉大的。非常感謝大家。

Sure.

當然。

Rachel Vatnsdal, JPMorgan.

摩根大通的 Rachel Vatnsdal。

Hi. This is Sebastian Sandler on for Rachel. Thank you for taking the question. So I wanted to touch on the NCCN update for multiple myeloma, which recommended the baseline clonal ID testing to enable MRD testing later on. You called out the 10% sequential growth in unique patients.

你好。這是 Sebastian Sandler 為 Rachel 表演的節目。感謝您回答這個問題。因此我想談談 NCCN 對多發性骨髓瘤的更新，它建議進行基線克隆 ID 測試，以便以後進行 MRD 測試。您提到了獨立患者數量連續增加 10%。

And since the update came in late June, I wouldn't think that 10% included any impact from the guideline update. I'm just wondering if you've seen any changes in ordering patterns, especially around that clonal ID testing and how that's been trending since the update. And then just how should we think about these unique IDs translating into MRD testing later on? Thank you.

而且由於更新是在 6 月底發布的，我認為 10% 並不包含指南更新的影響。我只是想知道您是否看到排序模式有任何變化，特別是圍繞克隆 ID 測試以及自更新以來的趨勢如何。那麼我們該如何考慮將這些唯一 ID 轉換為以後的 MRD 測試呢？謝謝。

Thanks for the question, Sebastian. What I would say to start is that the NCCN guidelines update certainly is a tailwind for us and something that we've been actively leveraging, particularly in the community setting in both our direct education of ACPs as well as the KOL-driven education that I mentioned earlier. It's helping us to deliver a message that we were already delivering, which is the importance of ensuring that each and every patient with multiple myeloma has the opportunity to be tracked by clonoSEQ.

謝謝你的提問，賽巴斯蒂安。首先我想說的是，NCCN 指南更新對我們來說無疑是一個順風，我們一直在積極利用它，特別是在社區環境中對 ACP 的直接教育以及我之前提到的 KOL 驅動的教育。它幫助我們傳遞我們已經傳遞的訊息，即確保每位多發性骨髓瘤患者都有機會被 clonoSEQ 追蹤的重要性。

And that opportunity is secured if you test at the time of diagnosis, or if at least you make sure that you collect an appropriate sample for subsequent NGS MRD testing. So while certainly it is, I think, a support to all of our goals, we are not projecting any specific increase in volumes as a result of that by itself. I think, again, it will contribute to the efforts that we already have ongoing. And I'm very optimistic that in the community setting, it will be compelling and credible as a reason for this to happen.

如果您在診斷時進行測試，或至少確保收集適當的樣本以進行後續的 NGS MRD 測試，那麼這個機會就有保障。因此，雖然我認為它肯定支持了我們所有的目標，但我們並沒有預期它本身會帶來任何具體的數量成長。我認為，這將再次促進我們已經在進行的努力。我非常樂觀地認為，在社區環境中，這將是一個令人信服且可信的理由。

We can anecdotally tell many stories of accounts that are currently evaluating and I think seriously considering upfront ID testing protocols in the community. There are already accounts that are doing that today. It is not the majority of our ID testing, and so we've seen fairly consistently about 30% of our test volume come from IDs over the last several years.

我們可以從軼事中講述許多目前正在評估的帳戶的故事，我認為社區正在認真考慮前期身份測試協議。今天已經有一些帳戶正在這樣做。這不是我們身分證測試的大多數，因此，在過去幾年中，我們相當穩定地看到大約 30% 的測試量來自身分證。

And I don't anticipate that dramatically changing but the balance of indications where we have more mature indications like ALL where many patients are ID-ed and new indications as well as myeloma where ID is becoming more of a -- there's more support for it. I think that we'll continue to see a strong contribution of ID testing over time.

我並不認為這種情況會發生巨大的變化，但適應症的平衡使我們有了更成熟的適應症，例如 ALL，其中許多患者被確診為 ID，而新適應症以及骨髓瘤，其中 ID 正變得越來越重要 - 對它的支持也越來越多。我認為，隨著時間的推移，我們將繼續看到身分識別測試的巨大貢獻。

Got it. Thanks. And then just one on the backlog. Seemed like that's growing nicely, closing at around $218 million after ending 2024, a little over $200 million. It also looks like the primary endpoints stepped up to 17 from 10 ending 4Q last year. So just how should we think about the burn there translating to sequencing revenues? And is there any meaningful difference in the burn rate between these primary versus secondary endpoints?

知道了。謝謝。然後就剩下一個待辦事項了。看起來成長勢頭良好，到 2024 年底將達到約 2.18 億美元，略高於 2 億美元。看起來主要終點也從去年第四季末的 10 個增加到了 17 個。那麼，我們究竟該如何看待燒錢轉換成收入排序呢？這些主要終點和次要終點之間的燃燒率是否存在任何有意義的差異？

And then lastly, have you seen any recent change in pharma customer behavior in that segment just given some of the headlines around tariffs and MFN, and do you anticipate any headwinds there going forward? I think some of your peers have called out a bit of bumpiness there, so just wondering if you're seeing any or building any into the guide. Thanks. (multiple speakers)

最後，考慮到有關關稅和最惠國待遇的一些新聞，您是否看到該領域的製藥客戶行為最近發生了任何變化？您是否預期未來會出現任何阻力？我認為您的一些同行已經指出了那裡存在一些不平整之處，所以我只是想知道您是否看到了一些不平整之處或在指南中提出了一些不平整之處。謝謝。（多位發言者）

As it relates to the backlog, I mean, in terms of the burn profile, I mean, I think of it as we're continuously replenishing our backlog with new bookings, and that's what's highlighted by the improving backlog relative to exit value of 2024. I think the timeframe of which that backlog converts into revenue is really unchanged, maybe a little bit of a pull forward.

至於積壓訂單，我的意思是，就燒錢情況而言，我認為我們正在不斷用新的預訂來補充積壓訂單，而這正是 2024 年退出價值相對積壓訂單的改善所強調的。我認為積壓訂單轉化為收入的時間框架實際上沒有改變，可能稍微提前了一點。

But obviously, with the dynamics at the FDA and our pharma partners' investments, it's still contingent upon when their trials are reading out, how many patients are enrolling, and when we can enable some of that MRD testing. But broadly, don't think the profile has changed dramatically, and we're going to continue to grow bookings. And we're confident in the pipeline we have around the pharma business.

但顯然，考慮到 FDA 的動態和我們製藥合作夥伴的投資，這仍然取決於他們的試驗何時讀取結果、有多少患者入組以及我們何時可以啟用一些 MRD 測試。但整體而言，情況並沒有發生巨大變化，我們的預訂量仍將持續增加。我們對製藥業務領域的通路充滿信心。

Yes, and as it relates to a more general question about our MRD Pharma business going forward and kind of impacts of tariffs, NIH, and the FDA, first, we'll start with kind of the tariffs and the FDA. There's very -- excuse me, tariffs and the NIH. There's very little impact as we look through kind of the portfolios. We're really not subject to NIH funding in terms of kind of very little percentage of our business.

是的，由於它涉及我們未來 MRD Pharma 業務的更普遍的問題以及關稅、NIH 和 FDA 的影響，首先，我們將從關稅和 FDA 開始。有非常——對不起，關稅和 NIH。當我們查看投資組合時，影響很小。就我們業務的很小一部分而言，我們實際上並不受 NIH 資助。

As it relates to the FDA, I would just start by saying globally that there is really a growing global support for MRD to use as an endpoint for the acceleration of therapy in multiple myeloma. And even more broadly, there's coalitions forming in other areas -- other indications as well. So we're very positive on acceleration of MRD therapies based on MRD. So the ODAC recommendation last year, along with the CHMP positive opinion on MRD -- using MRD as an early endpoint, it just continued in further validation of MRD as a predictor response. So overall, we're very kind of bullish on the MRD Pharma opportunity.

就 FDA 而言，我首先要說的是，在全球範圍內，越來越多的人支持將 MRD 作為加速多發性骨髓瘤治療的終點。更廣泛地說，其他領域也正在形成聯盟——也有其他跡象。因此，我們對基於 MRD 的 MRD 治療加速持非常積極的態度。因此，去年的 ODAC 建議以及 CHMP 對 MRD 的積極意見（使用 MRD 作為早期終點），只是繼續進一步驗證 MRD 作為預測反應。因此整體而言，我們非常看好 MRD Pharma 的機會。

Great. Thank you.

偉大的。謝謝。

Yuko Oku, Morgan Stanley.

奧裕子，摩根士丹利。

Hello. Thank you for taking my questions. CHMP opinion is supporting the use of MRD as an early endpoint in multiple myeloma clinical trials. How important was that milestone for your pharma customers in order to further incentivize incorporation of MRD as an endpoint? And then also, second part to that -- and given the halo effect that ODAC recommendation had on physicians in the US, does this also bring OUS opportunity into greater focus for you?

你好。感謝您回答我的問題。CHMP 意見支持使用 MRD 作為多發性骨髓瘤臨床試驗的早期終點。為了進一步激勵 MRD 作為終點，這個里程碑對於您的製藥客戶來說有多重要？然後還有第二部分——考慮到 ODAC 建議對美國醫生產生的光環效應，這是否也讓您更加關注 OUS 機會？

I'll start out, Yuko. Thank you for the question on CHMP. So I think that we saw this as further confirmation of what pharma sort of had already come to believe based on the ODAC vote and recommendation a year -- a little over a year ago. The CHMP decision was anticipated. And in fact, among our pharma partners who are currently executing or planning global clinical trials, they had expected that they would be able to leverage primary endpoint status for MRD in those settings.

我先走了，Yuko。感謝您就 CHMP 提出的問題。因此，我認為我們認為這進一步證實了製藥公司根據一年前（大約一年多前）的 ODAC 投票和建議已經形成的看法。CHMP 的決定是意料之中的。事實上，在我們目前正在執行或規劃全球臨床試驗的製藥合作夥伴中，他們期望能夠在這些環境中利用 MRD 的主要終點狀態。

So this was an important affirmation of that expectation and I think further supports the sort of global acceptance of MRD as a key endpoint in clinical trials for myeloma, as well as, frankly, other key malignancies. We're seeing growing support and growing utilization of MRD as a primary endpoint in other disease states.

因此，這是對這項期望的重要肯定，我認為這進一步支持了全球接受 MRD 作為骨髓瘤以及其他主要惡性腫瘤臨床試驗的關鍵終點。我們看到，在其他疾病狀態下，對 MRD 作為主要終點的支持和利用正在增加。

There are coalitions that have formed of pharma companies and investigators that are actively pursuing endpoint status for MRD, and we have signed a number of primary endpoint studies in diseases other than myeloma. I feel that that's, again, very supportive of what was already considerable momentum that was building post-ODAC.

製藥公司和研究人員已經組成聯盟，積極尋求 MRD 的終點狀態，我們已經簽署了多項針對骨髓瘤以外疾病的主要終點研究。我覺得這再次有力地支持了 ODAC 之後已經形成的強勁勢頭。

And then as it relates to the halo effect you described that ODAC had on HCPs here in the US, I think the OUS impact could be similar. I will say that regardless of that, we had already been, as Chad alluded to, starting to think about international expansion and how that might look. There is a significant opportunity outside the US, particularly in Europe, that we can consider pursuing. And I believe that CHMP's opinion and the European KOL's alignment with that opinion does support the opportunity outside the US as something that may be worthwhile to prioritize in the not-distant future.

然後，由於它與您所描述的 ODAC 對美國 HCP 產生的光環效應有關，我認為 OUS 的影響可能類似。我想說的是，不管怎樣，正如查德所提到的，我們已經開始考慮國際擴張以及它可能會是什麼樣子。美國以外，特別是歐洲，存在著重大機遇，我們可以考慮抓住。我相信 CHMP 的觀點以及歐洲 KOL 對此觀點的認同確實支持美國以外的機會，認為在不久的將來這可能是值得優先考慮的事情。

Great. Thank you. And then the MIDAS trial was also an important milestone for you that demonstrated utility of clonoSEQ in aiding physician decision to transplant in MM. Could you share some of the feedback from the physicians post data readout and whether you're already seeing some volume inflect as a result?

偉大的。謝謝。然後，MIDAS 試驗對您來說也是一個重要的里程碑，它證明了 clonoSEQ 在幫助醫生決定是否進行 MM 移植方面的實用性。您能否分享一些醫生發布的數據讀出的回饋，以及您是否已經看到了一些數據量的變化？

Sure. Feedback in general has been quite positive. This is the first time that a study that looked at this question was prospectively designed, randomized. And therefore, I think the results are more compelling than perhaps some earlier studies that sort of answered this question in an indirect way. It's also a very large study and was put forward by a very well-regarded and highly credible group of thought leaders from France.

當然。總體而言，反饋非常積極。這是第一次以前瞻性、隨機的方式研究這個問題。因此，我認為結果比一些以間接方式回答這個問題的早期研究更令人信服。這也是一項非常大規模的研究，是由法國一群非常受尊敬且極具可信度的思想領袖提出的。

So we've been very eager to bring it into conversation. I think interestingly, in the community setting, it really resonates, particularly in combination with the NCCN guideline update where we can say, it is important to ID your patient at the time of diagnosis so that you can then obtain this post-induction MRD assessment, which may allow you to avoid a transplant for your MRD-negative patient.

因此我們非常渴望討論這個問題。我認為有趣的是，在社區環境中，它確實引起了共鳴，特別是與 NCCN 指南更新相結合時，我們可以說，在診斷時識別患者非常重要，這樣您就可以獲得誘導後 MRD 評估，這可能使您避免對 MRD 陰性患者進行移植。

And in the community, what that means is you may not need to refer that patient away to an academic center for a transplant, which is a very appealing notion if it can be done in a safe way for the patient, which this data supports that it can. There is some consideration of the fact that this data will continue to develop. MRD response was the primary endpoint in this study, and that's something that is relatively new but now very common in a lot of study designs.

在社區中，這意味著你可能不需要將患者轉診到學術中心進行移植，如果可以以對患者安全的方式進行移植，這是一個非常有吸引力的想法，而這些數據支持這一點。有人考慮到這些數據將會繼續發展。MRD 反應是本研究的主要終點，這是一個相對較新的研究，但現在在許多研究設計中非常常見。

And so, some clinicians are interested to continue to see some of the longer-term follow up on this study, but overall, very, very -- very open, a lot of openness to this, a lot of discussion that it opens up. And the dialogue with the patient is, I think, the thing that people are most excited about to have something they can share with the patient who is hesitant about transplant, which is an increasing proportion of patients.

因此，一些臨床醫生有興趣繼續觀察這項研究的一些長期後續情況，但總的來說，非常非常開放，對此持非常開放的態度，並對此展開了很多討論。我認為，與患者的對話是人們最興奮的事情，他們可以與那些對移植猶豫不決的患者分享一些東西，而這類患者的比例正在增加。

Thank you.

謝謝。

(Operator Instructions) Okay, I am showing no further questions at this time. This does conclude the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

（操作員指示）好的，目前我沒有其他問題。問答環節到此結束。感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。