Adaptive Biotechnologies Corp (ADPT) 2025 Q3 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the Adaptive Biotechnologies Third Quarter Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Karina Calzadilla, Head of Investor Relations. Please go ahead.

    您好,感謝您的耐心等待。歡迎參加Adaptive Biotechnologies第三季財報電話會議。(操作人員指示)請注意,今天的會議正在錄音。現在我謹將會議交給今天的第一位發言人,投資者關係主管卡琳娜·卡爾扎迪拉。請繼續。

  • Karina Calzadilla - Vice President - Investor Relations

    Karina Calzadilla - Vice President - Investor Relations

  • Thank you, Jacinda, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies Third Quarter 2025 Earnings Conference Call. Earlier today, we issued a press release reporting Adaptive financial results for the third quarter of 2025. 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 Investors section in our corporate website.

    謝謝你,傑辛達,大家下午好。歡迎各位參加 Adaptive Biotechnologies 2025 年第三季財報電話會議。今天早些時候,我們發布了一份新聞稿,公佈了 Adaptive 公司 2025 年第三季的財務業績。新聞稿可至www.adaptivebiotech.com查閱。我們將對本次電話會議進行網路直播,並會參考已發佈在我們公司網站投資者關係欄目的幻燈片簡報。

  • During the call, management will make projections and other forward-looking statements within the meaning of federal securities laws regarding future events and the future financial performance of the company. These statements reflect management's current perspective of the business as 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 also in this presentation.

    在電話會議期間,管理層將根據聯邦證券法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截至目前為止對公司業務的看法。實際結果可能與今天的預測性聲明有重大差異,具體取決於許多因素,這些因素已在提交給美國證券交易委員會的公開文件中列出,並在本簡報中列出。

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

    此外,電話會議期間還將討論非GAAP財務指標,您可以在我們的獲利報告中找到非GAAP指標與GAAP指標的調節表。今天參加電話會議的有我們的執行長兼聯合創始人查德·羅賓斯,以及我們的財務長凱爾·皮斯克爾。管理層其他成員將出席問答環節。接下來,我會把電話交給查德。查德?

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thanks, Karina. Good afternoon, and thank you for joining us on our third quarter earnings call. I'm pleased to share another quarter of strong execution and accelerating momentum across the business. We delivered meaningful wins, sustained growth and further strengthened our financial position.

    謝謝你,卡琳娜。下午好,感謝各位參加我們第三季財報電話會議。我很高興地宣布,公司又一個季度業績強勁,業務發展勢頭持續加速。我們取得了意義重大的勝利,實現了持續成長,並進一步鞏固了我們的財務狀況。

  • Let's now turn to Slide 3 for a summary of this quarter's highlights. The MRD business delivered major profitability milestones. This quarter, adjusted EBITDA was $7 million, reflecting strong sequential growth. Also this quarter and ahead of plan, the MRD business became cash flow positive, a significant achievement that underscores the strength and scalability of our model. MRD revenue grew 52% year-over-year, driven by robust increases in clinical volume and ASP.

    現在讓我們翻到第 3 張投影片,總結本季的亮點。MRD業務實現了重要的獲利里程碑。本季調整後 EBITDA 為 700 萬美元,季增強勁。此外,本季 MRD 業務提前實現了正現金流,這是一項重大成就,凸顯了我們模式的實力和可擴展性。MRD 營收年增 52%,這主要得益於臨床業務量和 ASP 的強勁成長。

  • This growth reflects expanding clinical utility and broader integration of MRD testing into patient care. Clinical validation continues to deepen. The NCCN guidelines were updated again this quarter, this time in CLL, incorporating MRD-guided treatment options, providing more specific direction on testing frequency and supporting clonoSEQ ID testing at diagnosis.

    這一增長反映了 MRD 檢測在臨床應用方面的不斷擴大以及其在患者護理中更廣泛的應用。臨床驗證仍在不斷深入。NCCN 指南在本季度再次更新,這次是針對 CLL,納入了 MRD 指導的治療方案,對檢測頻率提供了更具體的指導,並支持在診斷時進行 clonoSEQ ID 檢測。

  • Operationally, we're scaling efficiently. With clonoSEQ now running on the NovaSeq X Plus, we're realizing meaningful cost efficiencies and expanding gross margins. Total company sequencing gross margin improved 10 percentage points year-over-year to 66%, and our focus on operating discipline is paying off. Operating expenses remained stable sequentially, while cash burn continued to decline. Through the first nine months of the year, we reduced cash burn by 51% versus last year, ending the quarter with a strong cash position of $217 million. Given this performance, we are again updating our full year guidance to reflect a higher MRD revenue range, lower operating expenses and a reduced annual cash burn. Kyle is going to cover the details shortly in his prepared remarks.

    營運方面,我們正在有效率地擴大規模。由於 clonoSEQ 現在運行在 NovaSeq X Plus 上,我們實現了顯著的成本效益並擴大了毛利率。公司整體排序毛利率年增 10 個百分點至 66%,我們對營運紀律的重視正在發揮成效。營運支出較上季保持穩定,而現金消耗持續下降。今年前九個月,我們的現金消耗量比去年同期減少了 51%,季末現金餘額達到 2.17 億美元。鑑於此業績,我們再次更新了全年業績預期,以反映更高的 MRD 收入範圍、更低的營運費用和更少的年度現金消耗。凱爾將在事先準備好的演講稿中詳細介紹情況。

  • Let's now turn to Slide 5 for a deeper look at the MRD business. clonoSEQ clinical revenue had impressive growth of 83% year-over-year and 18% quarter-over-quarter. We saw broad-based volume expansion across all reimbursed indications, delivering over 27,100 tests, up 38% versus prior year and up 7% sequentially. By indication, multi myeloma remained our largest contributor, accounting for 42% of US clonoSEQ volume, followed by ALL at 32%, CLL at 10%, DLBCL at 9% and MCL at 5%.

    現在讓我們來看第5張投影片,更深入了解MRD業務。 clonoSEQ的臨床收入實現了令人矚目的成長,較去年同期成長83%,較上季成長18%。我們看到所有報銷適應症的檢測量均大幅增長,檢測量超過 27,100 次,比上年增長 38%,環比增長 7%。從指標來看,多發性骨髓瘤仍是我們最大的貢獻者,占美國 clonoSEQ 檢測量的 42%,其次是 ALL(32%)、CLL(10%)、DLBCL(9%)和 MCL(5%)。

  • This volume growth continues to align with our strategic priorities. First, blood-based testing now represents 45% of volume, achieving our full year goal ahead of plan. And in multi myeloma, blood-based contribution reached 24%, up from 21% last year. Second, community-based testing represents 31% of total clonoSEQ volume with increasing contribution from Flatiron integrated accounts. Third, NHL testing expanded to 15% of total clonoSEQ volume, led by DLBCL and MCL sequential growth. Fourth, ordering HCPs grew 38% year-over-year to more than 4,100 with sequential growth of 9% in academic centers and 12% in community practices. And finally, we tested over 19,400 unique patients in the quarter, a 41% increase year-over-year and 8% sequentially.

    這一銷售成長與我們的策略重點持續保持一致。首先,血液檢測目前佔檢測量的 45%,提前實現了我們全年的目標。在多發性骨髓瘤中,血液來源的貢獻率達 24%,高於去年的 21%。其次,社群檢測佔 clonoSEQ 總檢測量的 31%,其中 Flatiron 整合帳戶的貢獻越來越大。第三,NHL 檢測量佔 clonoSEQ 總檢測量的 15%,其中 DLBCL 和 MCL 檢測量持續增加。第四,開立醫囑的醫療保健專業人員數量年增 38%,達到 4,100 多人,其中學術中心連續成長 9%,社區診所連續成長 12%。最後,本季我們對超過 19,400 名獨立患者進行了測試,較去年同期成長 41%,較上季成長 8%。

  • In addition to volume growth, we saw continued improvement in ASP with US clonoSEQ ASP increasing to over $1,340 per test, reinforcing our confidence to achieve full year average ASP of $1,300 or higher. During the quarter, we achieved several policy wins, including our first large commercial payer coverage in DLBCL and two major payers in CLL, bringing our total CLL covered lives to over 260 million. We continue to improve cash collections and expand our reimbursement footprint with new payer contracts. Overall, all ASP metrics and contracting initiatives are trending in the right direction, positioning us well to reach our long-term ASP target of $1,700 to $1,800 per test.

    除了銷售成長外,我們還看到 ASP 持續改善,美國 clonoSEQ ASP 已增加至每次測試 1,340 美元以上,這增強了我們實現全年平均 ASP 達到 1,300 美元或更高的信心。本季度,我們取得了多項政策勝利,包括首次獲得大型商業支付方對瀰漫性大B細胞淋巴瘤 (DLBCL) 的承保,以及獲得兩家主要支付方對慢性淋巴細胞白血病 (CLL) 的承保,使我們對 CLL 的承保總人數超過 2.6 億。我們不斷改進現金回收流程,並透過與新的付款方簽訂合約來擴大報銷範圍。總體而言,所有 ASP 指標和合約計劃都朝著正確的方向發展,使我們有信心實現每次測試 1700 至 1800 美元的長期 ASP 目標。

  • Let's now turn to Slide 6 to review progress on EMR integrations. Our EMR integration efforts continue to gain momentum across both academic and community settings. These integrations are a key driver of volume growth and support two other important strategic initiatives. The first is to build a scalable moat around clonoSEQ, protecting against new entrants and minimizing disruption from account turnover. And the second is to maximize clonoSEQ's usage across the care continuum by directly embedding into EMR-driven workflow, which translates into more tests per patient.

    現在讓我們翻到第 6 張投影片,回顧一下 EMR 整合的進展。我們在學術界和社區環境中推進電子病歷整合的工作正在不斷取得進展。這些整合是推動銷售成長的關鍵因素,並為另外兩項重要的策略措施提供支援。首先,要圍繞 clonoSEQ 建立一個可擴展的護城河,防止新進入者,並最大限度地減少帳戶更換帶來的干擾。第二點是將 clonoSEQ 直接嵌入 EMR 驅動的工作流程中,從而最大限度地提高其在整個護理過程中的使用率,這意味著每個患者可以進行更多的測試。

  • Since last quarter, we've completed 11 integrations, seven academic and four community with six of our top 10 accounts now integrated. Among accounts integrated with Flatiron last quarter, volume in these accounts grew 17% sequentially and now represent 24% of our community volume, up from 20% prelaunch. We're also leveraging integration to enable serial testing plans with many ordering providers at Flatiron integrated accounts selecting recurring testing at three, six or 12-month intervals. Importantly, nearly 40% of our commercial tests this quarter came from integrated accounts, which contributes to -- which continues to outpace growth from nonintegrated accounts.

    自上個季度以來,我們已完成 11 項整合,其中 7 項為學術整合,4 項為社區整合,目前我們前 10 名客戶中有 6 名已完成整合。在上個季度與 Flatiron 整合的帳戶中,這些帳戶的交易量較上季成長了 17%,目前占我們社區交易量的 24%,高於上線前的 20%。我們還利用整合功能,為 Flatiron 整合帳戶中的許多訂購提供者提供系列測試計劃,這些提供者可以選擇每三個月、六個月或十二個月進行一次循環測試。值得注意的是,本季我們近 40% 的商業測試來自整合帳戶,這有助於——繼續超過非整合帳戶的成長速度。

  • Looking ahead, we plan to further expand our EMR footprint and expect continued acceleration from integrated accounts with fewer ordering discrepancies and deeper account retention.

    展望未來,我們計劃進一步擴大 EMR 的應用範圍,並期望透過減少訂單差異和提高客戶留存率,實現整合帳戶的持續成長。

  • Let's turn to MRD Pharma on Slide 7. Our MRD Pharma business delivered a solid quarter with revenue up 11% year-over-year, including $6.5 million in milestone revenue. Multi myeloma remains the largest contributor to our biopharma portfolio at over 60% of our active trials, followed by CLL at 17% and ALL at 9%. We ended the quarter with a backlog of more than $200 million, reflecting strong partner demand and sustained program activity. clonoSEQ is most well established as an endpoint in multi myeloma, where the ODAC and CHMP votes reinforce its role in assessing treatment response and supporting accelerated approvals, particularly in the frontline setting.

    讓我們來看看第 7 張投影片中的 MRD 製藥公司。我們的 MRD 製藥業務本季業績穩健,營收年增 11%,其中包括 650 萬美元的里程碑營收。多發性骨髓瘤仍然是我們生物製藥產品組合中貢獻最大的藥物,占我們活躍試驗的 60% 以上,其次是慢性淋巴細胞白血病 (CLL),佔 17%,急性淋巴細胞白血病 (ALL),佔 9%。本季末,我們的積壓訂單超過2億美元,這反映了合作夥伴的強勁需求和持續的專案進度。 clonoSEQ作為多發性骨髓瘤的終點指標已被廣泛認可,ODAC和CHMP的投票結果進一步鞏固了其在評估治療反應和支持加速審批(尤其是在一線治療方面)方面的作用。

  • The momentum is now extending to other lymphoid cancers and driving diversification across our portfolio. Endpoint qualification efforts are underway in CLL and DLBCL, which are already translating into results. 2025 CLL bookings are more than twice what they were last year. Currently, the FDA is accepting MRD as an endpoint on a case-by-case basis in other lymphoid cancers. Of our 19 ongoing primary endpoint studies, 12 are in multi myeloma, six are in leukemia and one is in MCL.

    目前,這一勢頭正擴展到其他淋巴瘤領域,並推動我們投資組合的多元化發展。CLL 和 DLBCL 的終點指標鑑定工作正在進行中,並且已經取得了一些成果。2025 年 CLL 的預訂量是去年的兩倍多。目前,FDA 正在根據具體情況接受 MRD 作為其他淋巴瘤的終點指標。在我們正在進行的 19 項主要終點研究中,12 項針對多發性骨髓瘤,6 項針對白血病,1 項針對套細胞淋巴瘤。

  • While recent agency news views on surrogate endpoints have introduced some uncertainty, we remain confident MRD will gain broader acceptance as an endpoint for accelerated approval in other lymphoid cancers. As the first and only FDA-cleared MRD assay, clonoSEQ holds a distinct and durable position to capture this market. In summary, MRD is a strong growth engine with multiple levers to increase penetration.

    儘管最近有關替代終點的機構新聞觀點帶來了一些不確定性,但我們仍然相信 MRD 將作為其他淋巴瘤加速審批的終點得到更廣泛的接受。作為首個也是唯一一個獲得 FDA 批准的 MRD 檢測方法,clonoSEQ 在佔領市場方面擁有獨特且持久的地位。總之,MRD 是一個強大的成長引擎,擁有多種提高市場滲透率的手段。

  • Now let's turn to Immune Medicine on Slide 9. Our Immune Medicine business is executing across our three strategic priorities. First, we continue to generate large-scale, high-quality proprietary data to develop a digital TCR antigen prediction model. We're making good progress by using our data to train and improve the accuracy of our models. As we deploy these models, we see promising results in multiple immunology applications. One of these applications included the ability to select the best TCRs to use in cancer cell therapy products in partnership with Genentech.

    現在讓我們來看看第 9 張投影片中的免疫醫學部分。我們的免疫醫學業務正在圍繞三大策略重點開展工作。首先,我們繼續產生大規模、高品質的專有數據,以開發數位 TCR 抗原預測模型。我們利用自身資料來訓練和提高模型的準確性,並取得了良好的進展。隨著這些模型的應用,我們在多種免疫學應用中看到了令人鼓舞的結果。其中一個應用是能夠與基因泰克公司合作,選擇最佳的 TCR 用於癌細胞治療產品。

  • Earlier this quarter, we announced the conclusion of our partnership with Genentech following its internal portfolio prioritization. As a result, Adaptive is released from exclusivity and any further obligations related to this partnership. Importantly, the scientific and technical progress we've made along the way allowed us to significantly accelerate both our data generation and our AI/ML modeling capabilities across multiple use cases. We are deploying our knowledge and infrastructure that we built towards multiple high-value partnership opportunities.

    本季度早些時候,我們宣布由於基因泰克公司內部產品組合的優先排序,我們與該公司的合作關係已經結束。因此,Adaptive 解除了獨家合作關係以及與此合作關係相關的任何其他義務。重要的是,我們一路走來取得的科學和技術進步,使我們能夠在多個用例中顯著加快資料生成和人工智慧/機器學習建模能力。我們正在運用我們累積的知識和基礎設施,尋求多個高價值的合作機會。

  • Second, for our T cell depletion antibody program, we are on track to establish a preclinical data package in our lead autoimmune indication. This quarter, we selected our lead antibody candidate. This key milestone is based on robust potency and other functional characterization data that we generated this year. We've also started planning for CMC tox work, which represents a key step towards IND-enabling studies for this lead T-cell depleting antibody in autoimmunity. As we continue to execute on these two focused R&D priorities, we remain financially disciplined and are on track to achieve our 2025 cash burn target between $25 million and $30 million.

    其次,對於我們的 T 細胞清除抗體項目,我們正在按計劃建立我們主要自體免疫適應症的臨床前資料包。本季度,我們選定了主要抗體候選藥物。這個關鍵里程碑是基於我們今年獲得的可靠的效力和其他功能表徵數據而實現的。我們也開始規劃 CMC 毒理學研究,這對於這種治療自體免疫疾病的先導 T 細胞耗竭抗體而言,是進行 IND 申報研究的關鍵一步。在我們繼續推進這兩項重點研發工作的同時,我們保持財務紀律,並有望實現 2025 年現金消耗目標在 2,500 萬美元至 3,000 萬美元之間。

  • Now I'm going to pass it over to Kyle to walk through the financial results and updated full year guidance. Kyle?

    現在我將把麥克風交給凱爾,讓他來解讀財務表現和更新後的全年業績預期。凱爾?

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Thanks, Chad. First, I will go over the financial results, including $33.7 million of noncash revenue recognized this quarter from the remaining amortization of payments previously received from Genentech. Total company revenue for the third quarter was $94 million, representing a 102% increase year-over-year. Total company adjusted EBITDA was $28 million compared to a loss of $14.3 million a year ago.

    謝謝你,查德。首先,我將介紹財務業績,其中包括本季確認的 3,370 萬美元非現金收入,該收入來自先前從 Genentech 收到的剩餘款項的攤銷。該公司第三季總營收為 9,400 萬美元,年增 102%。公司調整後 EBITDA 總額為 2,800 萬美元,而去年同期虧損 1,430 萬美元。

  • Interest expense from our royalty financing agreement with OrbiMed was $3 million, which was $700,000 higher than interest income. Net income from the quarter was $9.5 million. Now and as shown on Slide 10, the revenue and adjusted EBITDA figures, which I will be discussing forward are presented excluding all noncash revenue from Genentech in all periods presented.

    我們與 OrbiMed 達成的特許權使用費融資協議的利息支出為 300 萬美元,比利息收入高出 70 萬美元。本季淨利為950萬美元。現在,如幻燈片 10 所示,我將在後面討論的收入和調整後的 EBITDA 數據,均不包括所有期間來自 Genentech 的非現金收入。

  • Looking at this quarter's performance on Slide 10. MRD revenue grew 52% year-over-year to $56.8 million, with clinical and pharma contributing 67% and 33%, respectively. clonoSEQ test volume, including international, increased 38% versus last year to 27,111 tests delivered. US ASP grew 28% to over $1,340, reflecting continued strength in cash collections and improved pricing through our various contracting initiatives. MRD Pharma revenue grew 11% year-over-year, inclusive of $6.5 million in milestones. Immune Medicine revenue from pharma and academic services was $3.4 million versus $5.5 million a year ago.

    請看第 10 張投影片,了解本季的業績。MRD營收年增52%至5,680萬美元,其中臨床和製藥業務分別貢獻了67%和33%。 clonoSEQ檢測量(包括國際檢測)較去年增加38%,達27,111例。美國平均售價成長 28%,超過 1,340 美元,反映出現金回收持續強勁,並透過我們的各種合約舉措提高了定價。MRD Pharma 的營收年增 11%,其中包括 650 萬美元的里程碑付款。來自製藥和學術服務的免疫醫學收入為 340 萬美元,而去年同期為 550 萬美元。

  • Turning to gross margins and expenses. Total company gross margin, again, excluding Genentech revenue, was 70%. Sequencing gross margin, which excludes MRD milestones, was 66%, up from 56% a year ago. This improvement was driven by operating leverage in the lab from higher volumes, stronger pricing across both clinical and pharma and efficiency gains from the NovaSeq X implementation.

    接下來談談毛利率和費用。不計基因泰克收入,公司總毛利率為 70%。不包括 MRD 里程碑的定序毛利率為 66%,高於一年前的 56%。這項改進得益於實驗室營運槓桿效應(產量增加)、臨床和製藥領域定價的增強以及 NovaSeq X 實施帶來的效率提升。

  • Total operating expenses, including cost of revenue, was $83.7 million, up 6% year-over-year and flat sequentially. The year-over-year increase was primarily driven by higher SG&A expenses related to our expected EMR and reimbursement efforts and higher cost of revenue from volume growth, partially offset by lower R&D expenses.

    包括營業成本在內的總營運支出為 8,370 萬美元,較去年同期成長 6%,較上季持平。與去年同期相比,成長主要受預期 EMR 和報銷工作相關的 SG&A 費用增加以及銷售成長帶來的收入成本增加所致,但研發費用降低部分抵銷了這些成長。

  • Turning to profitability. As shown on the segment reporting table at the bottom of the slide, the MRD business delivered positive adjusted EBITDA of $7 million compared to a deficit of $6.1 million a year ago. Immune Medicine adjusted EBITDA deficit, again, excluding the Genentech revenue, was $10 million versus $8.7 million in Q3 of last year. At the total company level, adjusted EBITDA, excluding Genentech, was a loss of $5.8 million compared to a $17.8 million loss a year ago. Total company net loss for the quarter was $24.2 million, again, excluding Genentech.

    轉向盈利。如幻燈片底部的分部報告表所示,MRD 業務實現了 700 萬美元的調整後 EBITDA 正收益,而一年前則虧損了 610 萬美元。免疫醫學業務經調整後的 EBITDA 虧損(同樣不包括 Genentech 的收入)為 1,000 萬美元,而去年第三季為 870 萬美元。從公司整體來看,不計入基因泰克公司,調整後的 EBITDA 虧損 580 萬美元,去年同期虧損 1,780 萬美元。該季度公司淨虧損總額為 2,420 萬美元,同樣不包括 Genentech。

  • Turning to our full year 2025 updated guidance on Slide 11. We are raising our full year MRD revenue guidance to a range of $202 million to $207 million, up from the prior range of $190 million to $200 million. This increase reflects stronger-than-expected clinical revenue performance in Q3 and higher MRD milestone revenue for the year. With sustained clinical volume momentum, we now expect to deliver approximately 104,000 tests for the year, exceeding our prior growth target of 35% over 2024. We also expect MRD milestone revenue between $18 million and $19 million, up from our previous $14 million to $15 million range.

    請翻到第 11 頁,查看我們 2025 年全年更新後的指導。我們將全年 MRD 收入預期從先前的 1.9 億美元至 2 億美元上調至 2.02 億美元至 2.07 億美元。這一增長反映了第三季臨床收入表現強於預期,以及全年 MRD 里程碑收入的提高。憑藉持續的臨床業務量成長勢頭,我們現在預計今年將完成約 104,000 次檢測,超過我們先前設定的 2024 年將成長 35% 的目標。我們也預期 MRD 里程碑營收將在 1,800 萬美元至 1,900 萬美元之間,高於我們先前預測的 1,400 萬美元至 1,500 萬美元的範圍。

  • Overall, this outlook implies 39% to 42% total MRD revenue growth year-over-year and 38% to 42% growth for the MRD base business, which excludes milestones at the midpoint. We are also tightening and lowering the top end of our total company operating expense guidance, including cost of revenue to $335 million to $340 million from our previous range of $335 million to $345 million. We continue to expect roughly 69% of expenses from MRD, 23% from Immune Medicine and the remainder from unallocated corporate costs.

    總體而言,這項展望意味著 MRD 總營收年增 39% 至 42%,MRD 基礎業務年增 38% 至 42%(不包括中間點的里程碑)。我們同時收緊並下調了公司整體營運費用指引的上限,包括營業成本,從先前的 3.35 億美元至 3.45 億美元下調至 3.35 億美元至 3.4 億美元。我們預計,MRD 的支出將佔總支出的約 69%,免疫醫學的支出將佔 23%,其餘部分將來自未分配的公司成本。

  • Further, we are also narrowing and lowering our full year company cash burn guidance to $45 million to $50 million from the prior $45 million to $55 million range, driven primarily by higher MRD revenue. We expect approximately 15% cash burn from MRD, still anticipate $25 million to $30 million from Immune Medicine and the balance from unallocated corporate costs. It's encouraging to see the MRD business generate positive cash flows, achieve positive adjusted EBITDA on the base business, all while continuing meaningful top line growth. With that, I'll hand it back over to Chad.

    此外,由於 MRD 收入增加,我們將全年公司現金消耗預期從先前的 4,500 萬美元至 5,500 萬美元下調至 4,500 萬美元至 5,000 萬美元。我們預計 MRD 將消耗約 15% 的現金,預計免疫醫學部門仍將獲得 2,500 萬至 3,000 萬美元的收入,其餘部分來自未分配的公司成本。令人鼓舞的是,MRD 業務產生了正現金流,在基礎業務上實現了正的調整後 EBITDA,同時繼續保持了有意義的營收成長。這樣,我就把它交還給查德了。

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thanks, Kyle. Our results this year highlight the strength of our strategy and the discipline of our execution. MRD is now a profitable scaling business that is delivering consistent growth and margin expansion and Immune Medicine continues to advance key R&D programs and unlock new partnership opportunities for future growth. We're confident in our trajectory and are well positioned to finish the year strong with a solid foundation for long-term value creation. With that, I'd like to now turn the call back over to the operator and open it up for questions.

    謝謝你,凱爾。我們今年的業績凸顯了我們策略的優勢和執行的嚴謹性。MRD 現已成為一家盈利且規模不斷擴大的企業,實現了持續增長和利潤率提升,免疫醫學部門也繼續推進關鍵研發項目,並為未來的成長開拓新的合作機會。我們對自己的發展軌跡充滿信心,並已做好充分準備,以堅實的基礎為長期價值創造,在年底前取得強勁的業績。接下來,我想把電話轉回給接線生,接受提問。

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Mark Massaro, BTIG.

    馬克·馬薩羅,BTIG。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • On the strong beat and raise. Just a question maybe to start. It looks like your MRD pharma business is becoming a little more recurring in nature than it was maybe a year ago, and it's actually starting to look linear, increasing about $1 million a quarter. I'm not expecting this to continue in a linear way. But can you just give us a sense of the $200 million you have in the backlog, how should we think about that backlog being released, say, over the next several quarters?

    強勁的節拍,然後上漲。先問個問題吧。看起來您的 MRD 製藥業務比一年前更具週期性,實際上開始呈現線性成長,每季成長約 100 萬美元。我不認為這件事會以線性方式繼續發展下去。但您能否簡要說明一下您積壓的 2 億美元訂單的情況,以及我們應該如何看待這些訂單在未來幾季內陸續交付的情況?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Thanks for the question, Mark. Thanks, Chad. Thanks for the question, Mark. So I think first, I'd just say that we are pleased with the performance of the business, and we will reiterate our anticipated revenues for the year. We think that the ODAC, the CHMP decisions in multiple myeloma as well as our strong pipeline in NHL and CNR increased accelerated progress in leukemia this year, all point to a strong potential for 2026 and beyond. We do expect -- we haven't provided guidance next year, but we do expect continuing growth in a similar range to where we've been this year. And I think the backlog, which we will recognize generally over a five to seven-year time frame, it is a strong backlog going into the year. And our new bookings have also been quite strong, and we expect that to continue given the role of MRD potentially as an endpoint in additional indications beyond multiple myeloma in the coming years.

    謝謝你的提問,馬克。謝謝你,查德。謝謝你的提問,馬克。所以首先,我想說我們對公司業績感到滿意,我們將重申我們對今年收入的預期。我們認為,ODAC 和 CHMP 在多發性骨髓瘤方面的決定,以及我們在 NHL 和 CNR 領域強大的研發管線,都加速了今年白血病治療的進展,所有這些都預示著 2026 年及以後將有巨大的發展潛力。我們預期-雖然我們沒有提供明年的業績指引,但我們預計明年的成長將與今年的成長幅度大致相同。我認為積壓的工作量,我們通常會在五到七年的時間範圍內看到,今年的積壓工作量非常大。我們的新預訂量也相當強勁,鑑於 MRD 在未來幾年可能作為多發性骨髓瘤以外的其他適應症的終點指標,我們預計這種情況會持續下去。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Okay. That's helpful. It's great to see the 38% growth in MRD volume. I guess as -- I'm not asking for hard guidance on 2026 or anything. But based on the fact that you've got Epic integrations, not just Epic, but other EMR integrations, you've got blood increasing, you've got community penetration increasing. You're testing a lot of new patients. There are a lot of drivers that are working in your favor. Is there any reason to think that perhaps a 30% bar is something that you can perform against in 2026 in terms of MRD volume growth?

    好的。那很有幫助。很高興看到 MRD 銷量成長了 38%。我想說的是——我並不是尋求關於2026年或其他任何方面的明確指導。但基於您擁有 Epic 集成,不僅是 Epic,還有其他 EMR 集成這一事實,您的血液流量會增加,您的社區滲透率也會增加。你們正在測試很多新患者。有很多因素對你有利。是否有任何理由認為,在 2026 年,您能夠實現 MRD 銷售量成長 30% 的目標?

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Mark, thanks for your question. As you mentioned, we're not going to specifically yet come out with 2026 guidance. I can just say all of the kind of underlying factors that you mentioned give us great confidence in the trajectory of the business in 2026 and beyond, and we will provide more specific guidance shortly.

    馬克,謝謝你的提問。正如您所提到的,我們目前不會具體發布 2026 年的指導意見。我只能說,您提到的所有潛在因素都讓我們對公司在 2026 年及以後的發展軌跡充滿信心,我們很快就會提供更具體的指導。

  • Operator

    Operator

  • Sabu Nambi, Guggenheim.

    薩布·南比,古根漢美術館。

  • Subbu Nambi - Analyst

    Subbu Nambi - Analyst

  • So again, in the spirit of just trying to model on clonoSEQ ASPs, can you help us think about next year? I know your long-term target is $1,800. But as we think about next year, it appears clonoSEQ is well on track to hit your target this year. How much should ASPs continue to lift from here?

    所以,本著嘗試對 clonoSEQ ASP 進行建模的精神,您能幫我們思考一下明年的情況嗎?我知道你的長期目標是 1800 美元。但展望明年,clonoSEQ 似乎有望在今年實現您的目標。平均售價(ASP)應該繼續上漲多少?

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Yes, [Subu], I appreciate the question. Look, I won't give a firm number yet on 2026. But what I can say is with the profile of the business and $1,340 in Q3, feel confident about the exit rate that we're going to exit the year at. With the momentum around coverage and not only CLL and what we're seeing in DLBCL as well, I think we're setting our foundation up fairly strong to go into 2026 to have meaningful growth in ASP. And that's where we think we are. And again, I reiterate that $1,700 to $1,800 long-range target, and we'll continue to grow for next year.

    是的,[Subu],感謝你的提問。聽著,我現在還不能給出2026年的確切數字。但我可以肯定的是,鑑於該公司的業務狀況和第三季 1340 美元的業績,我對我們今年的最終退出率充滿信心。鑑於目前在覆蓋範圍方面的良好勢頭,不僅是 CLL,還有我們在 DLBCL 方面看到的情況,我認為我們正在為 2026 年實現 ASP 的顯著增長奠定相當堅實的基礎。這就是我們認為自己所處的境地。我再次重申,我們的長期目標價為 1700 美元至 1800 美元,明年我們將繼續成長。

  • Subbu Nambi - Analyst

    Subbu Nambi - Analyst

  • Perfect. And another one for me. Our mature EMR integrations remaining strong, what do those run rates look like? And if still accelerating for the more mature accounts, how long before some of them actually steady off?

    完美的。又一個給我。我們成熟的電子病歷系統整合依然強勁,這些系統的運作速度如何?如果成熟帳戶的成長速度仍在加快,那麼其中一些帳戶的成長速度何時才能真正趨於穩定?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. I can answer that question, Subu. Thanks for asking. As you've seen, our EMR integrations have continued to progress well and to drive growth across really accounts of all sizes, both academic and community. And I'll just take a moment to mention that we don't just see the benefit of growth acceleration, but also we're protecting existing business from competition, and we're increasingly finding ways to utilize tools built within the EMR to help us increase the consistency and the frequency of testing, which will have long-term value for our growth in those accounts over time.

    當然。蘇布,我可以回答這個問題。謝謝你的提問。正如您所看到的,我們的 EMR 整合持續取得良好進展,並推動了各種規模的客戶(包括學術機構和社區機構)的成長。我還要花一點時間提一下,我們不僅看到了成長加速的好處,而且還在保護現有業務免受競爭,並且我們正在不斷尋找利用 EMR 內建工具的方法,以幫助我們提高測試的一致性和頻率,這將對我們在這些客戶中的長期成長產生價值。

  • We do see that the more mature integrated accounts do continue to grow more quickly than non-integrated accounts. That can vary to some extent based on the size of the account. As you can imagine, more well-penetrated accounts can't sustain those significant accelerations that we see post integration long term, but we see a variety of benefits in those large accounts even if they go back to sort of more stable growth rates after some time. We see that the integration helps democratize ordering. So more HCPs can place orders that reduces the impact of staff turnover. We see reduced HCP workload, which sort of eases the effort we have to put in to maintain that business, and we see -- we're strengthening our competitive moats.

    我們發現,較成熟的整合帳戶的成長速度確實比非整合帳戶更快。這在一定程度上會根據帳戶規模而有所不同。可以想像,滲透率較高的客戶無法長期維持整合後我們所看到的顯著增長速度,但即使這些大客戶在一段時間後恢復到較為穩定的增長率,我們仍然能看到它們帶來各種各樣的好處。我們看到,這種整合有助於實現訂購的民主化。這樣一來,更多的醫護人員可以下單,減少人員流動帶來的影響。我們看到 HCP 的工作量減少了,這在某種程度上減輕了我們維持這項業務所必須付出的努力,而且我們看到——我們正在加強我們的競爭優勢。

  • So even in those largest accounts, this has long-term benefits. in general, to give you some statistics, when we look at our integrated account commercial volumes this quarter -- in Q3 versus Q2, we saw 9% quarter-over-quarter growth across the entirety of the group, whether they were mature or newer and non-integrated accounts grew 6%. So a 50% increase in the growth rate just looking across the entire group. That group is getting bigger and the number of mature accounts is getting bigger over time, but it's still relatively small. Most of our integrations are less than a year old. So we'll have more to say as this continues, but we are confident that this is a real trend and that it's something that we can continue to build on with some of those tools I mentioned that the EMR offers us to optimize testing.

    因此,即使是最大的客戶,這種做法也具有長期效益。總的來說,舉幾個例子來說明,當我們查看本季度整合帳戶的商業交易量時——第三季度與第二季度相比,我們看到整個集團(無論成熟賬戶還是新賬戶)的環比增長了9%,而非整合賬戶的增長率為6%。因此,僅從整個群體來看,成長率就提高了 50%。隨著時間的推移,這個群體的規模越來越大,成熟帳戶的數量也在增加,但它仍然相對較小。我們的大部分整合項目都未滿一年。隨著事態發展,我們將發表更多看法,但我們相信這是一個真正的趨勢,我們可以繼續利用我提到的 EMR 為我們提供的優化測試的一些工具來發展這一趨勢。

  • Subbu Nambi - Analyst

    Subbu Nambi - Analyst

  • Fantastic. And given we recently initiated in most of our checks, we felt the competition was nonexistent almost or there was no close competitor, maybe a distant second. So when you refer to competitive moat, could you shed light on what kind of tests truly compete with clonoSEQ?

    極好的。鑑於我們最近才開始進行大部分檢查,我們感覺競爭幾乎不存在,或者沒有勢均力敵的競爭對手,可能只有遠遠落後的第二名。所以,當您提到競爭護城河時,您能否闡明哪些類型的測試真正能與 clonoSEQ 競爭?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure, of course. So in many of our indications, what we're really competing against is sort of lack of testing or use of traditional methods for disease burden assessments that aren't really MRD. And in those cases, we're focused primarily on educating clinicians on the clinical data, the utility, the use cases and now increasingly the guidelines, which are strongly supportive of MRD adoption. There are technologies like you're aware of, like traditional and next-generation flow that are utilized in academic institutions in-house that we have to compete against in those settings. And our data strongly supports the advantage of clonoSEQ over both traditional and next-gen flow, and you'll see some data at ASH actually that will look at that on top of many existing data sets that will continue to be favorable to clonoSEQ.

    當然可以。因此,在我們的許多指標中,我們真正要對抗的是缺乏檢測或使用傳統的疾病負擔評估方法,而這些方法實際上並非 MRD。在這些情況下,我們主要致力於向臨床醫生普及臨床數據、實用性、用例,以及現在越來越重視的指南,這些指南都強烈支持 MRD 的採用。正如您所了解的,學術機構內部使用一些技術,例如傳統流程和下一代流程,在這些領域,我們必須與這些技術競爭。我們的數據有力地支持了 clonoSEQ 相對於傳統流式細胞儀和下一代流式細胞儀的優勢,您將在 ASH 會議上看到一些數據,這些數據將結合許多現有的數據集來進一步證明 clonoSEQ 的優勢。

  • The one indication where we are seeing emerging competition is, of course, in [diffuse] large B-cell lymphoma. And competitors have entered the market. We anticipate we will continue to enter the market in the coming year. But the great news is that we're very confident in our position. We've established strong credibility. We have robust clinical experience. We've run more than 7,000 DLBCL tests in the past 12 months and had more than 900 HCPs order the test. So we're way ahead from a clinical -- from an established clinical base, and we have a number of other established advantages, commercial footprint, relationships our Medicare coverage and now our expanding commercial payer coverage, which we've just started to see really secure a foothold and the fact that we can offer universal testing for all lymphoid cancers. So even in a space where we may have more emerging competition, we do still believe we are well positioned to maintain our market-leading position.

    當然,我們看到競爭正在興起的一個跡像是瀰漫性大B細胞淋巴瘤。競爭對手也已進入市場。我們預計明年將繼續進入市場。但好消息是,我們對自己的地位非常有信心。我們已建立起強大的信譽。我們擁有豐富的臨床經驗。在過去的 12 個月裡,我們進行了 7000 多例 DLBCL 檢測,有 900 多位 HCP 訂購了該檢測。因此,我們在臨床方面遙遙領先——從已建立的臨床基礎來看,我們還有許多其他已確立的優勢,例如商業佈局、人際關係、醫療保險覆蓋範圍以及我們不斷擴大的商業支付方覆蓋範圍(我們剛剛開始看到這些覆蓋範圍真正站穩腳跟),以及我們可以為所有淋巴瘤提供普遍檢測這一事實。因此,即使在競爭日益激烈的領域,我們仍然相信我們有能力保持市場領先地位。

  • Operator

    Operator

  • Andrew Brackmann, William Blair.

    安德魯·布拉克曼,威廉·布萊爾。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Chad, I think you called out recent guideline wins this year and even in Q3. Obviously, we saw those throughout the year. But have you seen those sorts of changes to the guidelines start to impact utilization already? Or is that still something on the come? And then I guess bigger picture here, just on the commercial front, how are those updates perhaps maybe changing the conversation that your team is having with these docs?

    查德,我認為你今年,甚至在第三季度,都提到了最近在指導方針方面取得的勝利。顯然,我們全年都看到了這些情況。但是,您是否已經看到這些指南的改變開始對使用率產生影響?或者說,那還是尚未實現的計畫?然後,我想從更宏觀的角度來看,就商業層面而言,這些更新或許會如何改變你們團隊就這些文件的討論?

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Yes. Maybe I'll start and just kind of -- because we have had an impressive list of guideline wins this year, maybe I'll cover them and then I'll turn it over to Susan to talk about kind of the impact that we're seeing from a clinical standpoint.

    是的。也許我會先開始,然後——因為我們今年取得了一系列令人印象深刻的指南制定成果,也許我會介紹一下,然後我會把麥克風交給蘇珊,讓她談談我們從臨床角度看到的影響。

  • So first, I mean, there's been several meaningful guideline updates in multi myeloma, the recommendation to obtain a clonality ID assessment was really strengthened this year. And this is key for clonoSEQ to help them to reduce the barriers to the initial ID testing. It's also relevant to our education and penetration of the community, which is obviously a key driver of our growth. Also in DLBCL MRD assessment was included in the NCCN and lymphoma guidelines for the very first time. We mentioned CLL in the prepared remarks, the first time that the guidelines include a recommendation for serial MRD assessment and specified a frequency of three to six months. And also provides additional reinforcement about NGS being an alternative to flow, which Susan just mentioned.

    首先,我的意思是,多發性骨髓瘤領域已經出現了一些有意義的指南更新,今年對進行克隆性鑑定評估的建議得到了真正的加強。這對 clonoSEQ 來說至關重要,因為它可以幫助他們降低初始身分鑑定測試的障礙。這與我們面向社區的教育和滲透也息息相關,而這顯然是我們發展的關鍵驅動力。此外,DLBCL MRD 評估首次被納入 NCCN 和淋巴瘤指南。我們在準備好的演講稿中提到了 CLL,這是指南首次建議進行連續 MRD 評估,並規定評估頻率為三至六個月。此外,這也進一步強化了 NGS 作為流程的替代方案的觀點,正如 Susan 剛才所提到的。

  • So this is really just a great opportunity for us to educate on the data that emphasizes that clonoSEQ can detect disease that's missed by flow below a threshold of 10 to the four. This is definitely starting. I just want to be clear, these guidelines came out this year. That's certainly a helpful call point to go in with a strong data presentation, but I'll turn it over to Susan to talk about how it's impacting the clinical uptake.

    所以這確實是一個很好的機會,讓我們能夠透過數據來普及知識,強調 clonoSEQ 可以檢測到流式細胞儀在 10 的 4 次方閾值以下漏診的疾病。這絕對要開始了。我只想澄清一點,這些指導方針是今年出台的。這當然是一個有助於進行有力數據展示的切入點,但我會把這個主題交給蘇珊,讓她來談談它對臨床應用的影響。

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. Maybe I can just give you a couple of examples. So first of all, in multiple myeloma, we've been talking a lot about the [MIDS] data, which allows MRD-negative patients to potentially avoid a transplant. And in that setting, we can now, with the support of the guidelines, underscore the value of the ID test at diagnosis to make sure that no patient misses that opportunity. And that opportunity is particularly valued in the community setting where patients have to leave their local doctor to go get a transplant, neither the doctor nor the patient likes that. And so there's a lot of motivation and with the support of the guidelines to say that ID test is now -- there is a stronger recommendation around doing that, it ensures that more patients are accessible to this MIDS message that we're delivering.

    當然。或許我可以舉幾個例子給你聽。首先,在多發性骨髓瘤方面,我們一直在談論[MIDS]數據,這使得 MRD 陰性患者有可能避免移植。在這種情況下,在指南的支持下,我們現在可以強調診斷時進行 ID 測試的價值,以確保沒有患者錯過這個機會。在社區環境中,這種機會尤其珍貴,因為病人必須離開他們的當地醫生去接受移植手術,醫生和病人都不喜歡這樣。因此,在指南的支持下,我們更有動力說,ID 測試現在得到了更強有力的建議,這確保了更多的患者能夠獲得我們正在傳遞的 MIDS 訊息。

  • In CLL, where the guidelines were very recently updated. We're really just getting started, but we are exposing community doctors to some of the potential benefits of limited duration therapy, which many of them haven't experimented as much with yet, but we'll do more and more with the -- we expect upcoming approval of some of the combination regimens that are being referenced in the guidelines now. And so we can talk now about testing frequency in the context of a limited duration therapy in a much more specific way, which is what the community doctors really want. They want us to tell them when to test, who to test and the support of the guidelines just tremendously strengthens our ability to deliver that message.

    慢性淋巴細胞白血病(CLL)的指南最近進行了更新。我們才剛起步,但我們正在向社區醫生介紹短期療法的潛在益處,他們中的許多人還沒有過多嘗試過這種療法,但我們會越來越多地進行嘗試——我們預計指南中提到的一些聯合療法很快就會獲得批准。因此,我們現在可以更具體地討論有限療程療法的檢測頻率,這正是社區醫生真正想要的。他們希望我們告訴他們何時進行檢測、檢測對象,而這些指導方針的支援極大地增強了我們傳遞這一訊息的能力。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Susan, maybe a follow-up there. I think in an earlier question, you referenced tools in the EMR to increase the frequency of testing and getting that scheduled maybe. Just sort of practically, what are you referencing there? And I guess, how does that drive the increased utilization here?

    蘇珊,或許可以跟進一下。我認為在先前的問題中,您提到了電子病歷中的工具,可以提高檢測頻率並安排檢測時間。實際上,你指的是什麼?那麼,這又是如何推動這裡的利用率提高呢?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. Yes. A couple of things that I'm referencing are things like treatment plans and order sets. So there are ways within Epic, let's say, that a clinician or a department can set up specific sets of actions that they want to take for a given type of patient at a given point in time. And we are now talking to clinicians in our integrated accounts increasingly about how clonoSEQ might be incorporated into order sets, how do guidelines, existing data, well vetted clinical trial designs support specific time points, where are there places where you might want to make decisions? Would you want to have the clonality ID incorporated into the diagnostic workup.

    當然。是的。我提到的幾個方麵包括治療方案和醫囑集。因此,在 Epic 系統中,臨床醫生或科室可以透過一些方法,針對特定類型的患者在特定時間點設定他們想要採取的特定操作。我們現在越來越多地與我們綜合帳戶中的臨床醫生討論 clonoSEQ 如何納入醫囑集,指南、現有數據、經過充分審查的臨床試驗設計如何支援特定時間點,以及在哪些方面您可能需要做出決定?您是否希望將克隆性 ID 納入診斷流程?

  • All of those things can be facilitated by tools that are built into Epic. Additionally, there are tools that allow you to do essentially analytics and reporting on your patient population. And so for example, very easily and Epic you can pull up a list of all the patients who are within, let's say, one month of the end of a frontline induction regimen in DLBCL. And you can make sure that your staff has those patients on their radar to place a clonoSEQ order when they come in. So that kind of thing is incredibly powerful. And it's really where we're -- you're going to hear us talking a lot more in 2026 about those types of things because we're shifting from just get as many accounts integrated as possible. We'll continue to do that, but now we can also look at our integrated accounts and what are all the opportunities to use those tools.

    所有這些都可以透過 Epic 內建的工具來實現。此外,還有一些工具可以讓你對患者群體進行分析和報告。例如,在 Epic 系統中,您可以非常輕鬆地調出所有 DLBCL 一線誘導治療方案結束一個月內的患者名單。您可以確保您的員工留意這些患者,並在他們就診時下訂單進行 clonoSEQ 檢測。所以這種東西威力非常強大。這就是我們目前的發展方向——到 2026 年,你會聽到我們談論更多這類事情,因為我們正在從盡可能整合帳戶轉向其他方向。我們將繼續這樣做,但現在我們還可以查看我們的整合帳戶以及使用這些工具的所有機會。

  • Operator

    Operator

  • Sebastian Sandler, JPMorgan.

    Sebastian Sandler,摩根大通。

  • Sebastian Sandler - Analyst

    Sebastian Sandler - Analyst

  • Congrats on the quarter. My first question is on community. I think that had another solid quarter. It seems to be continuing to accelerate. Can you just help us level set where we stand in penetration into the community, which is where most of the heme cancer patients are treated? And then do you have any color on whether the sequential increase in HCPs from these practices are coming from new accounts versus existing accounts? And I think you've kept your sales force headcount relatively stable. So I'm wondering if you have any plans to expand as you penetrate further into the community setting? And I have a follow-up.

    恭喜你本季取得佳績。我的第一個問題是關於社區的。我認為他們又度過了一個穩健的季度。這種趨勢似乎還在加速。您能否幫助我們了解我們在社區滲透方面所處的階段,因為大多數血液癌症患者都是在社區接受治療的?那麼,您能否透露一下,這些診所的醫療保健專業人員數量持續成長,是來自新客戶還是現有客戶?我認為你們的銷售團隊人數一直保持相對穩定。所以我想知道,隨著你們進一步滲透到社區領域,是否有任何擴張計劃?我還有一個後續問題。

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. Thanks, Sebastian. Let me see if I can touch on all of those. So first of all, our community penetration, while we've made substantial headway and now have about 30% of our volume coming from community settings, we still are underpenetrated certainly relative to academic settings and have a very high ceiling in that space. We are taking, as you know, specific steps to drive growth in that setting, one of which is the recent integration with OncoEMR via Flatiron Health. And we've been really pleased with the results we've seen in the Flatiron accounts.

    當然。謝謝你,賽巴斯蒂安。讓我看看能不能都談到這些。首先,就我們的社區滲透率而言,雖然我們已經取得了相當大的進展,現在大約 30% 的業務量來自社區環境,但相對於學術環境而言,我們的滲透率仍然不足,而且在這個領域還有很大的提升空間。如您所知,我們正在採取具體措施來推動該領域的成長,其中一項措施是最近透過 Flatiron Health 與 OncoEMR 進行整合。我們對 Flatiron 帳戶的表現非常滿意。

  • I'll just briefly mention that we saw 17% quarter-over-quarter growth in Q3 in our Flatiron accounts. and we're only one quarter into our experience, but quite a lot of interest and opt into our serial testing offering in that interface, which we'll learn more about how we can pull those tests through in the coming months. But a lot of potential that I think we can build on with the option of serial test ordering in community settings.

    我簡單提一下,我們在Flatiron帳戶方面,第三季環比成長了17%。雖然我們才剛開始一個季度的嘗試,但已經有許多用戶對我們的平台測試功能表現出了濃厚的興趣並選擇參與其中。在接下來的幾個月裡,我們將進一步了解如何更好地進行這些測試。但我認為,在社區環境中採用連續檢測的方式,我們可以充分利用其巨大的潛力。

  • In terms of the HCPs, where are they coming from, we have a lot of white space in the community still. And so we are -- while it takes time to break into new accounts, we continue to see new HCPs in both new and existing accounts. In the existing accounts, integration is a big driver of bringing new HCPs on board because, again, it democratizes the ability to order. And the new accounts will continue to penetrate. There are Flatiron accounts that don't yet use clonoSEQ, and so that's a big area of focus, but outside of that segment as well.

    就醫療保健專業人員而言,他們來自哪裡?我們社區在這方面仍有許多空白領域。因此,雖然打入新客戶需要時間,但我們仍然在新客戶和現有客戶中不斷看到新的醫療保健專業人員。對於現有客戶而言,整合是吸引新 HCP 加入的重要驅動力,因為它再次實現了訂購能力的民主化。新帳戶還會繼續滲透。有些 Flatiron 帳戶尚未使用 clonoSEQ,因此這是一個需要重點關注的領域,但除此之外,還有其他領域也需要關注。

  • In terms of the sales force, we've looked at this carefully, and we are comfortable with the 65 reps that we have, of which about half are focused on the community setting. What I'd say is that this is the right number of reps based on what we can see in terms of potential in each territory, the number of accounts and HCPs each rep is calling on, the amount of windshield time that the reps have. We do look carefully at our alignment, and we will occasionally add a territory or collapse the territory when we see some specific opportunity. And over time, we will consider potentially new deployment strategies that could justify additional hiring, but we're not anticipating any significant expansion in the near term.

    就銷售團隊而言,我們已經仔細研究過,我們對現有的 65 名銷售代表感到滿意,其中大約一半專注於社區環境。我認為,根據我們在每個地區的潛力、每個銷售代表拜訪的客戶和醫療保健專業人員的數量以及銷售代表的實地拜訪時間來看,這個銷售代表的數量是合適的。我們會仔細審視我們的陣營,當發現一些特定的機會時,我們偶爾會增加或減少某個區域。隨著時間的推移,我們將考慮可能的新部署策略,這些策略可能需要額外的招聘,但我們預計近期內不會有任何重大擴張。

  • Sebastian Sandler - Analyst

    Sebastian Sandler - Analyst

  • Got it. Very helpful. And then my second question is on sequencing gross margins. So those had a nice step up. Can you give us a little more granularity on the individual drivers of that improvement? I think more of the uplift from the X transition was expected to fall more in 4Q, but I'm wondering if that benefit was accelerated and had an outsized impact in 3Q? And then any color on how we should think about sequencing gross margins exiting the year would be helpful.

    知道了。很有幫助。我的第二個問題是關於毛利率排序。所以他們取得了不錯的進步。您能否更詳細地說明促成這項改進的具體因素?我認為X轉型帶來的成長預期會在第四季大幅下降,但我想知道這種成長是否提前到來,並在第三季產生了過大的影響?此外,如果能就我們應該如何考慮年底毛利率的排序提供一些見解,那就太好了。

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Thanks, Sebastian. Yes, I appreciate the comment. Sequencing gross margin was 66%, and that was up from 64% in Q2. I'd say if you drill in a little deeper on the MRD business alone, it was up 3 percentage points and NovaSeq X contributed 2 percentage points of that. So certainly taking out the [Lion's] share of the improvement. We were only integrated starting at the end of July, so really two months of benefit. So expect it to continue. And in terms of guidance as it relates to exiting the year, we said 5 to 8 percentage points post launch, still reaffirming that. And I think we'll see a continued step-up, especially as the volume continues to grow exiting the year.

    謝謝你,賽巴斯蒂安。是的,感謝您的評論。定序毛利率為 66%,高於第二季的 64%。如果深入分析 MRD 業務,就會發現它成長了 3 個百分點,其中 NovaSeq X 貢獻了 2 個百分點。所以,這無疑佔據了改進的大部分份額。我們從七月底才開始整合,所以實際上只享受了兩個月的福利。所以預計這種情況還會持續下去。至於年底的業績指引,我們之前說過上市後會成長 5 到 8 個百分點,現在仍然重申這一點。我認為我們會看到持續成長,尤其是在年底交易量持續成長的情況下。

  • Operator

    Operator

  • William Bonello, Craig-Hallum.

    威廉·博內羅,克雷格·哈勒姆。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • I just want to circle back to the question that Andrew was asking about the EMR tools. Did I hear you right earlier in the call that you said with -- and I need to be clarified whether it was Epic or OncoEMR, but that a physician now has the ability to essentially put in an order that would cover multiple testing time periods upfront. And then if I did hear that right, maybe you can talk a little bit more about how that works, if that's available for all indications, can a practice customize? Are they -- you mentioned some time points, but I don't know if those are fixed order points or a doctor has flexibility around that? And then maybe what kind of lift do you think you might be able to get from that capability in terms of test per patient?

    我只想回到安德魯之前問的關於電子病歷工具的問題。我剛剛在電話裡聽到你說——我需要確認一下是 Epic 還是 OncoEMR——醫生現在可以預先下達涵蓋多個檢測時間段的醫囑,對嗎?如果我沒理解錯的話,您能否再詳細談談它是如何運作的,它是否適用於所有適應症,診所是否可以進行客製化?是嗎?你提到了一些時間點,但我不知道這些是固定的時間節點,還是醫生可以彈性安排?那麼,您認為利用這項能力,在每位患者的檢測量方面,可以取得怎樣的提升呢?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. I'd be happy to talk more about that, William. So the serial testing option is available to our Flatiron integrated accounts. So OncoEMR offers this as an option in their interface that we've taken advantage of. And what essentially happens is when you're placing an order, you have to select from a drop-down whether you'd like a single order or a serial cadence, which can vary from one, three, six or 12 months. And so it's as simple as selecting from the dropdown. And that is universal for all OncoEMR accounts that utilize their molecular precision NPI tool, which is what we use to provide integrated test ordering. It's across all indications. It isn't customizable in the sense that it looks the same for every practice, but it is up to the HCP what cadence they select. And so we do see variability depending on whether an HCP is going to do blood or bone marrow, depending on whether they're testing in DLBCL or CLL, et cetera.

    當然。威廉,我很樂意就此多談。因此,串行測試選項適用於我們整合 Flatiron 的帳戶。因此,OncoEMR 在其介面中提供了這一選項,我們已經利用了它。實際上,當你下訂單時,你需要從下拉式選單中選擇是單次訂單還是按順序下單,順序可以是 1 個月、3 個月、6 個月或 12 個月。因此,只需從下拉式選單中選擇即可。對於所有使用 OncoEMR 分子精準 NPI 工具的 OncoEMR 帳戶來說,情況都是如此,而我們正是利用該工具提供整合測試訂購服務。各項指標都顯示如此。它並非可自訂的,因為每個診所看起來都一樣,但醫療保健專業人員可以自行選擇節奏。因此,我們看到,根據醫療保健專業人員是進行血液檢查還是骨髓檢查,根據他們檢測的是瀰漫性大B細胞淋巴瘤還是慢性淋巴細胞白血病等情況,結果會有所不同。

  • We haven't quantified the specific lift associated with this yet because, as I mentioned, we're only three months in, and most clinicians are selecting a three or six month cadence. And so we are just now getting to the point where we'll be able to start measuring, do we pull those orders through or do the physicians elect to delay or not send the sample. So -- but we are confident based on the early results that we will get incremental test growth from that offering, and we are looking at whether there are ways to extend it to other parts of our business beyond Flatiron.

    我們還沒有量化與此相關的具體提升幅度,因為正如我所提到的,我們才進行了三個月,而且大多數臨床醫生選擇每三個月或六個月進行一次治療。所以,我們現在終於要開始衡量了,我們是否會執行這些訂單,或者醫生是否會選擇延遲或不發送樣本。所以——但根據早期結果,我們有信心透過這項服務獲得測試數量的成長,我們正在研究是否有辦法將其擴展到 Flatiron 以外的其他業務領域。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • And so if a physician, for instance, selects a three month cadence, does that mean that for a period of time, every three months, another test is being ordered? I just want to make sure I understand that.

    例如,如果醫生選擇三個月的檢查週期,這是否意味著在一段時間內,每三個月都要進行一次檢查?我只是想確認一下我是否理解了。

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Correct. I mean it's essentially that way, but what happens is it's like a placeholder order. So the order is scheduled into the patient's calendar within the EMR system. And then when that due date comes up, it will sort of pop up for the staff in the clinic and say this patient is due for another blood draw for a clonoSEQ test. The staff still have to take the action to make that blood draw happen before it comes to us and officially count as an order. So none of these orders are appearing in our order numbers. But if we pull them through, which we are actively working to do by putting in place reminders and field-based tactics to ensure that our clinicians are aware that these orders are coming due, we'll be able to -- we expect, pull some number of those through and be able to provide more consistent testing to patients over time.

    正確的。我的意思是,本質上就是這樣,但實際情況就像是一個佔位訂單。因此,該醫囑會被安排到電子病歷系統中病患的日曆中。然後,當到期日到來時,診所工作人員就會收到通知,告知該患者需要再次抽血進行 clonoSEQ 測試。工作人員仍需採取行動完成抽血,之後血液樣本才會送到我們這裡,正式計入醫囑。因此,這些訂單都沒有出現在我們的訂單號碼中。但是,如果我們能把這些訂單落實到位,我們正在積極努力,透過設定提醒和現場策略,確保我們的臨床醫生意識到這些訂單即將到期,我們預計能夠落實其中一部分訂單,並隨著時間的推移為患者提供更一致的檢測。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Okay. That's really helpful. And then just a completely different question for you guys. Where are we at in terms of blood today and uptick with blood as sort of a percent of what you're seeing? And what are your thoughts on that looking forward?

    好的。這真的很有幫助。那麼,我再問你們一個完全不同的問題。目前血液狀況如何?血液成長幅度佔總成長幅度的百分比是多少?展望未來,您有什麼看法?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. So overall, we have now reached 45% of all MRD tests being performed in blood. And that was actually our goal for the year. So we're pleased to have achieved that a quarter early was to exit the year at 45% was our expectation. We are seeing increases in blood-based testing in both myeloma and ALL, which are sort of traditionally marrow-based tests. We now are at 37% of ALL tests in blood and 24% of multiple myeloma tests in blood. That's each up about 3 to 4 absolute percentage points from a year ago. And we also have increased contribution from our primarily blood-based indications, which include DLBCL, MCL and CLL. DLBCL, in particular, is driving some of the growth in blood-based testing because it's simply becoming a larger portion of our total test base.

    當然。因此,總體而言,目前已有 45% 的 MRD 檢測是在血液中進行的。而這其實也是我們今年的目標。因此,我們很高興提前一個季度實現了目標,我們原本預期年底的完成率為 45%。我們看到,在多發性骨髓瘤和急性淋巴性白血病(ALL)的檢測中,血液檢測的數量有所增加,而傳統上這些檢測都是基於骨髓的。目前,所有檢測項目中有 37% 採用血液檢測,多發性骨髓瘤檢測項目中有 24% 採用血液檢測。這比一年前分別提高了約 3 到 4 個百分點。此外,我們主要基於血液的適應症(包括 DLBCL、MCL 和 CLL)的貢獻也有所增加。特別是瀰漫性大B細胞淋巴瘤(DLBCL),正在推動血液檢測的成長,因為它在我們整體檢測群體中所佔的比例越來越大。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Sure. Okay. And then if I can, just one last question. You mentioned the national contract wins and just the way the bullet points were on the slide, I wasn't totally sure if you were saying those were related, if there were two distinct points, are the rate increases related to just DLBCL and CLL? Or are those across all modalities? And then secondly, did we see any benefit from that this quarter? Or is that all ahead of us?

    當然。好的。如果可以的話,我最後一個問題。您提到了贏得全國性合同,但從幻燈片上的要點來看,我不太確定您是否認為這些是相關的。如果是兩個不同的點,那麼費率上漲是否僅與 DLBCL 和 CLL 有關?或者這些情況適用於所有模式?其次,本季我們是否從中看到了任何收益?或者,這一切都還在我們前方?

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Yes, I'll start and then, Kyle, feel free to jump on. First, there's a difference between kind of coverage and potentially rate increases, although those can sometimes be combined. What I mentioned in the prepared remarks is that we were -- we obtained coverage, our first commercial payer coverage in DLBCL and that for two CLL coverage policies, we obtained kind of further coverage. So those will hit -- those hit now and -- but then you'll see the impact come over time, not -- those wouldn't be reflected in this quarter.

    好的,我先開始,然後,凱爾,你隨時可以加入。首先,保險範圍和潛在的費率上漲是有區別的,儘管這兩者有時可以結合起來。我在準備好的演講稿中提到,我們獲得了保險,這是我們在瀰漫性大B細胞淋巴瘤(DLBCL)方面獲得的第一份商業保險,並且我們還獲得了兩份慢性淋巴細胞白血病(CLL)保險,獲得了進一步的保險。所以這些影響——現在就會有影響——但隨著時間的推移,你會看到影響逐漸顯現,而不是——這些影響不會在本季反映出來。

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Yes, that's right. And the contracting initiatives or wins we flagged were in effect in Q3. So some of that pull through in Q3. We still think there's some room to go just from an implementation perspective with some of those payers that we're still working some of the kinks through, but we'll get there on that front.

    是的,沒錯。我們先前提到的合約簽訂計畫或得標項目在第三季已經生效。所以其中一些成果會在第三季顯現出來。從實施的角度來看,我們仍然認為還有一些提升空間,因為我們仍在與一些支付方解決一些問題,但我們終將在這方面取得成功。

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Just to give you a good example. Remember, we discussed a major payer win in terms of contracting kind of for Anthem last quarter and the implementation of -- actually probably two quarters ago and the implementation happened this quarter. So you do start seeing a lift in terms of your ASP from that. So there's a lag often between contracting and implementation and kind of the rate increase and/or the rate increase.

    舉個例子。請記住,我們上個季度討論過 Anthem 在合約方面取得的重大勝利,以及實施——實際上可能是在兩個季度前,而實施是在本季度進行的。所以你會看到你的平均售價因此有所提升。因此,從簽訂合約到實施,再到利率上漲,通常都會存在一定的延遲。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Okay. That makes sense. And when I go back and look at it, I see it's sort of two distinct points, right? [You get] coverage policy from the two plus I am reading that right, though, that there were three national payer price increases, like you're saying those -- Kyle, you're saying (inaudible) --

    好的。這很有道理。當我回過頭來看的時候,我發現這其實是兩個截然不同的點,對吧?[你獲得的]保險政策來自兩家保險公司,而且我理解的沒錯吧,你說有三家全國性的保險公司漲價了,就像你說的那些——凱爾,你是說(聽不清楚)——

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Correct.

    正確的。

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • That was in effect in Q3.

    該措施在第三季生效。

  • Operator

    Operator

  • David Westenberg, Piper Sandler.

    大衛‧韋斯滕伯格,派珀‧桑德勒。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • So I want to maybe start with the contribution margin of MRD at this point. I mean I know you're maybe not going to give the exact number, but I'm just kind of thinking about how -- as we see growth in that, we see this move to cash flow breakeven and kind of our ability to kind of pace that. And then also, just given the fact that you do have a pretty solid competitive lead in MRD in blood at this point. How are you thinking about balancing investments in sales and marketing, et cetera, to really like push on that competitive advantage, maybe clinical studies or anything else there?

    所以,我想先從 MRD 的貢獻毛利開始談起。我知道你可能不會給出確切的數字,但我只是在想——隨著我們看到這方面的增長,我們看到現金流收支平衡的轉變,以及我們控制這一轉變速度的能力。而且,考慮到你目前在血液 MRD 檢測方面確實擁有相當穩固的競爭優勢。您打算如何平衡銷售和行銷等方面的投資,以真正發揮競爭優勢,例如進行臨床研究或其他相關活動?

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Yes. Thanks, David. On the contribution margin comment, certainly, we have control to be able to manage and pace the growth as long as we continue to see and expect to see the growth. Again, this quarter was a great accomplishment to see the cash flow positivity, which gives us some confidence going forward that the business will remain cash flow positive. That being said, we may choose to make some additional investments to press the gas and grow faster, either in volumes and/or in the reimbursement environment. So I think all of those things get combined give us a little bit of control. And as the volume continues to increase, we can decide whether or not we want to reinvest in the business and what areas we want to go after.

    是的。謝謝你,大衛。關於邊際貢獻率的評論,當然,只要我們繼續看到並預期看到成長,我們就有能力管理和控製成長速度。再次強調,本季現金流為正是一項巨大的成就,這讓我們對公司未來的現金流保持為正充滿信心。也就是說,我們可能會選擇進行一些額外的投資,以加快成長速度,無論是在銷售方面還是報銷方面。所以我覺得所有這些因素結合起來,能讓我們獲得一些控制權。隨著業務量的持續成長,我們可以決定是否要對業務進行再投資,以及我們想要進軍哪些領域。

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Maybe I'll add on to that and then Susan can as well. First, I think it's worth pointing out, even though we've had great growth, there's still a long way to go in penetration in order to fully capture this kind of large and expanding total addressable market opportunity. But particularly in terms of investments, we are continuing to invest in kind of blood-based testing, both in terms of assay improvements and in terms of clinical studies, in an addition to kind of blood-based testing, I think that's a key initiative for us overall is investing in clinical studies to continue to demonstrate the clinical utility of the assay as where a doctor can use our test to kind of improve patient care across the continuum, and we'll continue to make those investments.

    或許我會補充一些內容,然後蘇珊也可以。首先,我認為值得指出的是,儘管我們取得了巨大的成長,但要充分把握這種龐大且不斷擴大的潛在市場機遇,我們在市場滲透方面還有很長的路要走。但尤其是在投資方面,我們將繼續投資於血液檢測,包括檢測方法的改進和臨床研究。除了血液檢測之外,我認為我們的一項關鍵舉措是投資臨床研究,以繼續證明檢測方法的臨床實用性,即醫生如何使用我們的檢測來改善整個患者護理過程,我們將繼續進行這些投資。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Got it. Just real one quick one on the guide, and apologies, I've been jumping between three calls here. But is there any seasonality in the Q4 MRD number? I mean I think you've had sequential growth of, I think it was 10%, 10%, 7%. I realize you can't maintain that forever. But I think the guide would kind of imply that maybe the volumes or the ASPs might be a little bit lower than what you've gotten in the quarter-over-quarter. Just wanted to see if you can remind us on the seasonality there. And yes, I'll just stop there.

    知道了。關於指南,我只想簡單提一句,抱歉,我一直在接聽三通電話。但第四季 MRD 數據是否有季節性波動?我的意思是,我認為你們的成長率是連續的,我認為是 10%、10%、7%。我知道你不可能永遠維持下去。但我認為該指南似乎暗示,銷量或平均售價可能會比上一季略低。只是想請您提醒我們那裡的季節性情況。是的,我就說到這裡吧。

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Yes. Yes. As it relates to guide, certainly something we are contemplating with respect to our guidance. Obviously, the volume growth has been phenomenal, and we expect it to continue to be phenomenal. But Q4 is one of the tougher periods with the amount of holidays and ordering. So I think that factored into some of our guide. But again, longer term and into '26, we think there's strong growth ahead of us. So there's a little bit of seasonality in that growth. It doesn't mean we can't beat it, but that is factored into our guide.

    是的。是的。至於指導方面,這當然是我們正在考慮的問題。顯然,銷量成長非常驚人,我們預計這種驚人的成長動能將持續下去。但由於假日和訂單量較大,第四季是比較艱難的時期之一。所以我認為這影響了我們的一些指導原則。但從長遠來看,到 2026 年,我們認為未來將有強勁的成長動能。所以這種成長有一定的季節性。這並不意味著我們無法戰勝它,但這已考慮在我們的策略中。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Got it. Maybe I'll just squeeze in one quick one. I might be at the end of the queue anyway. So just in terms of your thoughts on outside of multiple myeloma potential to see this as a primary -- or clonoSEQ as a primary endpoint, specifically written in is clonoSEQ or NGS clonality, et cetera? And how far away are we from that? I mean I'm guessing we're seeing a lot of speeding up of clinical trials and really seeing more promising drugs coming through the pipeline because of this. When can we see that advancement to other sorts of areas like CLL, ALL non-Hodgkin lymphoma, et cetera?

    知道了。或許我可以擠出時間快速完成一個。反正我可能也要排在隊伍的最後。那麼,就您認為在多發性骨髓瘤之外,將 clonoSEQ 作為主要終點(或者俱體來說是 clonoSEQ 或 NGS 克隆性等)是否可行呢?我們距離那個目標還有多遠?我的意思是,我猜想正因如此,我們才會看到臨床試驗的速度大大加快,並且有更多有希望的藥物進入研發階段。我們什麼時候才能看到這種進展擴展到其他領域,例如慢性淋巴球白血病、急性淋巴性白血病、非何杰金氏淋巴瘤等等?

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. As I think Chad mentioned earlier, we have -- there are active efforts ongoing for both CLL and DLBCL to establish a similar designation as the ODAC provided for myeloma for MRD as an accelerated endpoint for approval. The CLL effort is being led by a number -- a couple of KOLs and in partnership with a broad coalition of pharma partners. We are actually getting engaged in that effort as well directly. And what the leaders of that initiative have said to us is that it took 10 years for multiple myeloma. It will not take 10 years for CLL. That's because we now have a blueprint for what the FDA is looking for.

    當然。正如查德之前提到的,我們正在積極努力,爭取將 CLL 和 DLBCL 也納入 ODAC 為骨髓瘤提供的 MRD 作為加速審批終點的類似認定範圍。CLL 的研發工作由多人領導——包括幾位關鍵意見領袖,並與廣泛的製藥合作夥伴聯盟合作。我們實際上也直接參與這項工作。該計劃的領導者告訴我們,多發性骨髓瘤的發現花了 10 年。慢性淋巴球白血病不需要10年時間。那是因為我們現在有了FDA想要的那種藍圖。

  • Now that said, the FDA has evolved since the time of the ODAC vote, and so there are uncertainties around that. But the data collection is advancing rapidly. And I think all the participants are confident that current administration notwithstanding, we'll see those things come to fruition much faster than they did in multiple myeloma. And I think that other indications beyond CLL and DLBCL may have reason to explore this in the future as well.

    話雖如此,自從 ODAC 投票以來,FDA 已經發生了變化,因此這方面存在一些不確定性。但數據收集工作正在快速推進。我認為所有參與者都相信,儘管現任政府有所作為,但這些事情的實現速度將比多發性骨髓瘤的治療速度快得多。我認為,除了 CLL 和 DLBCL 之外的其他適應症,未來也可能值得探索這種方法。

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • And just one point in terms of quantifying this in terms of kind of bookings, our 2025 CLL bookings are more than twice what they were last year in the MRD pharma space.

    就預訂量而言,我們2025年的CLL預訂量是去年MRD製藥領域的兩倍多。

  • Operator

    Operator

  • Dan Brennan, TD.

    丹·布倫南,TD。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Maybe just on DLBCL, I mean, the mix ticked up pretty nicely in the quarter. I know you may have addressed it a little bit, but just speak to a little bit what you're seeing there and how we might think about the opportunity there as we go into '26 in terms of the pace of progress.

    或許只是在DLBCL上,我的意思是,這個季度他們的表現相當不錯。我知道您可能已經稍微談到過這一點,但請再談談您在那裡看到了什麼,以及隨著我們進入 2026 年,在發展速度方面,我們應該如何看待那裡的機會。

  • Susan Bobulsky - Chief Commercial Officer - MRD

    Susan Bobulsky - Chief Commercial Officer - MRD

  • Sure. Thanks for the question, Dan. Yes, we are continuing to see a nice solid uptick in the contribution of DLBCL, rising from 6% a year ago -- three quarters ago to 9% this quarter. It's kind of poised to overtake CLL actually as the third largest indication probably in the next quarter or two, although we'll certainly expect the CLL business to be buoyed by the recent guidelines update.

    當然。謝謝你的提問,丹。是的,我們繼續看到瀰漫性大B細胞淋巴瘤(DLBCL)的貢獻穩定成長,從一年前(三個季度前)的6%上升到本季的9%。它實際上有望在未來一兩個季度內超越 CLL,成為第三大適應症,儘管我們肯定會期待 CLL 業務受到最近指南更新的提振。

  • In DLBCL, I think a couple of things contributing. Certainly, one is the noise around MRD in the space, which is not just coming from us. There is a large amount of data generation ongoing. There is a lot of interest from pharma companies and how they can utilize MRD-guided treatment to optimize outcomes in this disease state, which is curable for a subset of patients and hopefully for a growing number of patients, proportion of patients over time.

    我認為,瀰漫性大B細胞淋巴瘤(DLBCL)的發生與發展有以下幾個原因。當然,其中一個原因是該領域圍繞 MRD 的噪音,而這些噪音並非僅來自我們。目前有大量數據正在產生。製藥公司對此非常感興趣,他們想知道如何利用 MRD 指導的治療來優化這種疾病的治療效果。這種疾病對一部分患者來說是可以治癒的,而且隨著時間的推移,有望治癒的患者數量和比例都會不斷增加。

  • So there are several companies that are currently advancing or considering trials that will include MRD-guided elements to them in the coming years. And that will -- in addition to the interest in the clinic as it is, that will contribute, I believe, to greater use cases for MRD in the clinic.

    因此,目前有幾家公司正在推進或考慮在未來幾年內進行包含 MRD 指導元素的試驗。我相信,除了目前臨床上對 MRD 的興趣之外,這將有助於在臨床上推廣 MRD 的更多應用案例。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Great. And maybe just a follow-up. I know there's a few questions on margins. But just wondering as an early read, if we think about into '26 and the investments you're making, but yet the OpEx leverage path you're on, just can you remind us how we might think about the early look on OpEx leverage as we go into '26 and what are the key puts and takes?

    偉大的。或許還需要後續跟進。我知道還有一些關於利潤率的問題。但我想提前了解一下,如果我們展望 2026 年以及您正在進行的投資,但您目前採取的營運支出槓桿策略,您能否提醒我們,在進入 2026 年之際,我們應該如何看待營運支出槓桿,以及有哪些關鍵的利弊?

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Yes. I mean I think we will continue to see growth in investment areas like EMR. But at this point, we're not planning any major investments. That being said, we might change our mind. But at this point, I think we're going to continue to see meaningful leverage across the business and look at opportunities to take advantage of the position we're in, in the MRD business.

    是的。我的意思是,我認為像電子病歷這樣的投資領域將會持續成長。但目前我們沒有任何重大投資計畫。話雖如此,我們或許會改變主意。但就目前而言,我認為我們將繼續在整個業務中發揮有意義的槓桿作用,並尋找機會利用我們在 MRD 業務中的地位。

  • Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

    Chad Robins - Chairman of the Board, Chief Executive Officer, Co-Founder

  • The other area that I mentioned earlier, Dan, continuing to invest in kind of data generation for clinical utility studies. But overall, we're looking to continue to get leverage out of the business.

    丹,我之前提到的另一個領域是繼續投資於臨床實用性研究的資料產生。但總的來說,我們希望繼續從業務中獲得優勢。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Have you guys even -- like I forget, have you commented publicly at all about OpEx leverage for '26 in terms of where consensus is or no, not yet?

    你們有沒有——我忘了​​,你們有沒有公開評論過 2026 年的營運支出槓桿作用,例如大家的共識是什麼,或者還沒有?

  • Kyle Piskel - Chief Financial Officer

    Kyle Piskel - Chief Financial Officer

  • Not yet. Not yet.

    還沒有。還沒有。

  • Operator

    Operator

  • This concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

    問答環節到此結束。感謝您參加今天的會議。節目到此結束。您現在可以斷開連線了。