Adaptive Biotechnologies Corp (ADPT) 2023 Q3 法說會逐字稿

Thank you for standing by. At this time, I would like to welcome everyone to today's Adaptive Biotechnologies 2023 Third Quarter Earnings Call. (Operator Instructions) I'd now like to turn the call over to Karina Calzadilla, Head of Investor Relations. Karina, please go ahead.

謝謝你的支持。此時此刻，我謹歡迎大家參加今天的 Adaptive Biotechnologies 2023 年第三季財報電話會議。 （操作員說明）我現在想將電話轉給投資者關係主管 Karina Calzadilla。卡琳娜，請繼續。

Thank you, Brett, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies Third Quarter 2023 Earnings Conference Call. Earlier today, we issued a press release reporting Adaptive financial results for the third quarter of 2023. 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.

謝謝布雷特，大家下午好。歡迎您參加 Adaptive Biotechnologies 2023 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，報告了 Adaptive 2023 年第三季的財務業績。新聞稿可在 www.adaptivebiotech.com 上取得。我們正在對本次電話會議進行網路直播，並將參考已發佈在我們公司網站投資者部分的幻燈片簡報。

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 in this presentation.

在電話會議期間，管理階層將就聯邦證券法意義內的未來事件和公司未來的財務表現做出預測和其他前瞻性陳述。這些陳述反映了管理層目前對業務的看法。實際結果可能與今天的前瞻性陳述有重大差異，具體取決於我們向美國證券交易委員會提交的公開文件中列出並在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 Tycho Peterson, our Chief Financial Officer. Additional members from management will be available for Q&A. With that, I will turn the call over to Chad Robins. Chad?

此外，電話會議期間將討論非公認會計原則財務指標，並且可以在我們的收益發布中找到從非公認會計原則到公認會計原則指標的調節表。今天參加電話會議的有我們的執行長兼聯合創始人 Chad Robins 和我們的財務長泰科彼得森 (Tycho Peterson)。管理層的其他成員將可以參加問答。這樣，我會將電話轉給查德·羅賓斯。查德?

Thanks, Karina. Good afternoon, everybody, and thank you for joining us on our third quarter 2023 earnings call. This quarter marks a pivotal moment in Adaptive's evolution. As we have previously shared, we have 2 compelling businesses in MRD and Immune Medicine. They are at disparate stages of maturity with different investment requirements, operating models and distinct value drivers. To maximize the full potential of each business, we have hired Goldman Sachs to assist with a review of strategic alternatives.

謝謝，卡琳娜。大家下午好，感謝您參加我們的 2023 年第三季財報電話會議。本季標誌著 Adaptive 發展的關鍵時刻。正如我們之前分享的，我們在 MRD 和免疫醫學領域擁有兩項引人注目的業務。它們處於不同的成熟階段，具有不同的投資要求、營運模式和獨特的價值驅動因素。為了最大限度地發揮每項業務的全部潛力，我們聘請了高盛協助審查策略替代方案。

We will provide clarity on the path forward by early next year. Why are we making this decision now? MRD is a pure-play diagnostic business with strong moats supporting clonoSEQ's established position as the gold standard in heme MRD. Its continued momentum and success will require focused commercial execution to drive increased penetration in current and new indications as well as further investment and operational scale to solidify its path to profitability. In contrast, Immune Medicine is now fully focused on drug discovery supported by a major achievement this quarter with the discovery of a novel target in multiple sclerosis. These data validate our target discovery approach in autoimmunity, with the ability to unlock additional novel targets in multiple autoimmune indications.

我們將在明年初之前明確前進的道路。為什麼我們現在就做出這個決定？ MRD 是一家純粹的診斷業務，擁有強大的護城河，支持 clonoSEQ 作為血紅素 MRD 黃金標準的既定地位。其持續的動力和成功將需要集中的商業執行，以推動當前和新適應症的滲透率，以及進一步的投資和營運規模，以鞏固其獲利之路。相較之下，免疫醫學現在完全專注於藥物發現，本季取得了重大成就，發現了多發性硬化症的新標靶。這些數據驗證了我們在自體免疫方面的標靶發現方法，能夠在多種自體免疫適應症中解鎖更多新標靶。

The combination of our drug discovery platform with Genentech in oncology and the discovery of this first novel autoimmune target gives us a clear path to successfully build a broad and differentiated therapeutics business. We are confident in the value these businesses can deliver to patients and shareholders and expect that this ongoing strategic review will yield the best path forward to maximize their respective potential. In light of this process and the evolution of our Immune Medicine business into a dedicated drug discovery model with line of sight to long-term value creation, we are updating total company revenue guidance for the year to exclude revenue from the Immune Medicine business. However, as you will hear from Tycho, we will provide you with MRD guidance for the remainder of 2023.

我們的藥物發現平台與腫瘤學領域的基因泰克結合，以及第一個新型自體免疫標靶的發現，為我們成功建立廣泛且差異化的治療業務提供了一條明確的道路。我們對這些業務能為患者和股東帶來的價值充滿信心，並期望正在進行的策略審查將為最大限度地發揮各自潛力提供最佳的前進道路。鑑於這一過程以及我們的免疫醫學業務演變為專注於長期價值創造的藥物發現模型，我們正在更新今年的公司總收入指引，以排除免疫醫學業務的收入。然而，正如您將從第谷聽到的那樣，我們將為您提供 2023 年剩餘時間的 MRD 指南。

Importantly, we continue to drive operational efficiencies throughout the organization. We completed the lab move this quarter, which is essential for future margin improvement, and we maintain a healthy cash position with about $371 million in cash on the balance sheet. Let's now take a closer look at our MRD business, starting with clinical testing on Slide 4.

重要的是，我們繼續提高整個組織的營運效率。我們本季完成了實驗室搬遷，這對於未來利潤率的提高至關重要，並且我們保持健康的現金狀況，資產負債表上有約 3.71 億美元的現金。現在讓我們仔細看看我們的 MRD 業務，從幻燈片 4 上的臨床測試開始。

clonoSEQ clinical testing continues to generate record high volumes quarter-over-quarter. This quarter, volume grew 10% sequentially and 56% versus prior year to over 15,000 tests delivered. Growth came from all marketed indications with multi myeloma as the largest contributor and the main growth driver. Ordering accounts and ordering health care providers grew 30% and 33% versus prior year, respectively.

clonoSEQ 臨床測試持續產生季度環比創紀錄的高產量。本季度，交付量超過 15,000 次，較上季成長 10%，與去年同期相比成長 56%。成長來自所有上市適應症，其中多發性骨髓瘤是最大的貢獻者和主要成長動力。訂購帳戶和訂購醫療保健提供者分別比去年增長了 30% 和 33%。

Business in the Community segment grew 25% quarter-over-quarter, contributing 21% of clonoSEQ volume in Q3 versus 13% a year ago. Blood-based testing increased in all indications and grew 14% sequentially, contributing 36% of all MRD tests. Included among the many presentations highlighting clonoSEQ data at ASH this year will be new evidence demonstrating the prognostic value of blood-based clonoSEQ testing in myeloma.

社群區隔市場的業務較上季成長 25%，佔第三季 clonoSEQ 銷售量的 21%，而去年同期為 13%。基於血液的檢測在所有適應症中均有所增加，環比增長 14%，佔所有 MRD 檢測的 36%。今年 ASH 上強調 clonoSEQ 數據的眾多演講中將包括新的證據，證明基於血液的 clonoSEQ 檢測在骨髓瘤中的預後價值。

Speaking of data, in Q3, we saw 2 important new clonoSEQ data sets published, one in mantle cell lymphoma where clonoSEQ's deep sensitivity of 10^6, was shown to have prognostic power and one in Ph+ ALL, where clonoSEQ was favorably compared to the current PCR-based monitoring standard. Last quarter, we saw downward pressure on our ASPs driven by well understood factors. Actions we have taken to address these pressures are already beginning to contribute to positive ASP trends as we saw consistent month-over-month increases in Q3 and 3% overall ASP growth versus Q2.

說到數據，在第三季度，我們看到發布了2 個重要的新clonoSEQ 數據集，一個用於套細胞淋巴瘤，其中clonoSEQ 的深度敏感性為10^6，被證明具有預後能力；另一個用於Ph+ ALL，其中clonoSEQ 優於目前基於 PCR 的監測標準。上個季度，由於眾所周知的因素，我們的平均售價面臨下行壓力。我們為應對這些壓力而採取的行動已經開始為積極的 ASP 趨勢做出貢獻，因為我們看到第三季度持續逐月增長，整體 ASP 與第二季度相比增長了 3%。

These positive trends, I'm happy to say, are continuing into the fourth quarter. Our plan to further optimize ASP is focused on coverage expansion, growth in contracted lives, improvement in payer mix and operational enhancements to improve collections. Specifically, we have invested in resources dedicated to claims management, transition the majority of our commercial payers to the new, unique clonoSEQ CPT code and closed additional payer contracts and policy gaps. We are confident these and other planned initiatives will accelerate ASP growth for the next several years.

我很高興地說，這些正面趨勢將持續到第四季。我們進一步優化平均售價的計劃專注於覆蓋範圍擴大、合約壽命增長、付款人結構改善以及營運增強以改善收款。具體來說，我們投資了專門用於索賠管理的資源，將我們的大多數商業付款人過渡到新的、獨特的 clonoSEQ CPT 代碼，並彌補了額外的付款人合約和保單缺口。我們相信這些和其他計劃中的舉措將在未來幾年加速 ASP 的成長。

In addition, Epic integration continues to progress. We launched our first site, UC Davis Health this quarter, and we have 4 more sites that we anticipate launching by the end of 2023. We also have a vetted list of interested accounts and anticipate 20 to 25 sites integrated by the end of 2024. Revenue declined 4% in the quarter versus prior year due to broader macroeconomic factors. Now I'm actually looking at Slide 5 on MRD pharma. Revenue declined 4% in the quarter versus prior year due to broader economic -- macroeconomic factors impacting the biopharma industry.

此外，Epic 整合也不斷取得進展。我們本季推出了第一個網站 UC Davis Health，預計到 2023 年底還會推出另外 4 個網站。我們還有一份經過審查的興趣帳戶列表，預計到 2024 年底將整合 20 到 25 個網站。由於更廣泛的宏觀經濟因素，本季營收較上年同期下降4%。現在我實際上正在看有關 MRD pharma 的幻燈片 5。由於影響生物製藥行業的更廣泛的經濟宏觀經濟因素，本季營收較上年同期下降 4%。

Like many of our peers, we are seeing pressure from some studies pausing or slowing down while companies re-prioritized portfolios and specific assets. This has resulted in lower sample volume across our portfolio of prospective trials. Despite these transitory headwinds, the overall health of the business is strong with over $190 million in backlog anticipated by year-end. We launched an updated version of our ctDNA assay for use by our pharma partners in research and clinical trials for DLBCL. We plan to leverage the updated assay in our upcoming DLBCL FDA submission and deploy it for clinical testing and studies in other heme malignancies.

與我們的許多同行一樣，我們看到一些研究暫停或放緩的壓力，同時公司重新確定了投資組合和特定資產的優先順序。這導致我們的前瞻性試驗組合的樣本量減少。儘管存在這些暫時的不利因素，但該業務的整體健康狀況仍然強勁，預計到年底積壓金額將超過 1.9 億美元。我們推出了 ctDNA 檢測的更新版本，供我們的製藥合作夥伴用於 DLBCL 的研究和臨床試驗。我們計劃在即將向 FDA 提交的 DLBCL 提交文件中利用更新後的檢測方法，並將其用於其他血紅素惡性腫瘤的臨床測試和研究。

We also continue to add meaningful partnerships to our portfolio. This week, we announced a new translational agreement with BeiGene to measure MRD across its pipeline. In summary, the setup for MRD is solid. Execution to drive top line revenue growth while improving cost efficiencies is essential to drive this business towards profitability by 2025.

我們也繼續在我們的產品組合中增加有意義的合作關係。本週，我們宣布與百濟神州達成新的轉換協議，以衡量其整個管道的 MRD。總之，MRD 的設定是可靠的。執行力推動營收成長，同時提高成本效率，對於推動該業務在 2025 年實現獲利至關重要。

Turning to Immune Medicine on Slide 6. As mentioned earlier, we achieved a key milestone in the discovery of a novel druggable target in multiple sclerosis. This target was discovered based on our unique ability to accurately identify a specific set of TCRs that are found only in MS patients. This MS target sheds light on potentially new T cell biology that may be the trigger to this devastating disease. It also validates our novel target discovery approach, which uses our established drug discovery platform. This discovery was accelerated by our ability to accurately identify T cell signatures of disease which is enabled by combining our improved machine learning AI models that we built with our partner, Microsoft, and our existing TCR characterization capabilities.

轉向幻燈片 6 上的免疫醫學。如前所述，我們在發現多發性硬化症的新型藥物標靶方面實現了一個關鍵里程碑。該標靶的發現基於我們獨特的能力，能夠準確識別僅在多發性硬化症患者中發現的一組特定 TCR。這個 MS 目標揭示了潛在的新 T 細胞生物學，它可能是這種毀滅性疾病的觸發因素。它還驗證了我們的新穎標靶發現方法，該方法使用我們已建立的藥物發現平台。我們能夠準確地識別疾病的 T 細胞特徵，這加速了這一發現，這是透過將我們與合作夥伴 Microsoft 共同建構的改進的機器學習 AI 模型與我們現有的 TCR 表徵能力相結合來實現的。

We're applying this exact same approach to discover novel targets and additional autoimmune disorders that we strategically prioritize. Regarding our cancer cell therapy partnership with Genentech, this quarter, our early product development team has successfully built out our personalized process workflow in South San Francisco under regulated conditions. With the key building blocks now in place, we're starting end-to-end testing that defines the foundation for future clinical readiness of our fully personalized process.

我們正在應用這種完全相同的方法來發現我們策略上優先考慮的新目標和其他自體免疫疾病。關於我們與基因泰克的癌細胞治療合作夥伴關係，本季度，我們的早期產品開發團隊在規範條件下成功地在南舊金山建立了我們的個人化流程。關鍵建置模組現已到位，我們正在開始端到端測試，為我們完全個人化流程的未來臨床準備奠定基礎。

In summary, we continue to make great progress in our target and drug discovery programs in cancer and autoimmunity. Our Immune Medicine business remains laser focused to execute on additional key R&D and future clinical proof points that drive meaningful value inflections for our partnered and wholly-owned drug discovery pipeline.

總之，我們在癌症和自體免疫領域的標靶和藥物發現計畫中繼續取得巨大進展。我們的免疫醫學業務仍專注於執行額外的關鍵研發和未來的臨床證明點，為我們的合作和全資藥物發現管道帶來有意義的價值轉變。

With that, I'll now pass it over to Tycho.

現在我將把它交給第谷。

Thanks, Chad. Turning to our financials on Slide 7. Total revenue in the third quarter was $37.9 million, with 65% from MRD and 35% from Immune Medicine, representing a 21% decline from the same period last year. The MRD business overall has been strong, driven by high volume growth of clonoSEQ. The total revenue decline in 3Q was primarily driven by a 61% reduction in Genentech amortization and a 14% decrease in MRD pharma and Immune Medicine pharma services due to the biopharma headwinds that we previously discussed, partially offset by strong clonoSEQ clinical performance.

謝謝，查德。轉向幻燈片 7 上的財務數據。第三季總收入為 3,790 萬美元，其中 65% 來自 MRD，35% 來自免疫醫學，比去年同期下降 21%。在 clonoSEQ 銷售量大幅成長的推動下，MRD 業務整體表現強勁。第三季總收入下降主要是由於我們之前討論過的生物製藥逆風導致基因泰克攤銷減少 61% 以及 MRD 製藥和免疫醫學製藥服務減少 14%，部分被強勁的 clonoSEQ 臨床表現所抵消。

MRD revenue grew 24% from a year ago to $24.7 million. clonoSEQ clinical was the main driver with test volume, including international, increasing 56% to 15,072 tests delivered from 9,649 tests in the same period last year. MRD Pharma declined 4% and no milestones were recognized in the quarter. Immune Medicine revenue was $13.3 million, down 52% from a year ago, with lower Genentech amortization driving 85% of the decline. Immune Medicine pharma services, which saw a 29% decline versus the prior year also experienced downward pressure from biopharma.

MRD 營收較上年同期成長 24%，達到 2,470 萬美元。 clonoSEQ 臨床是測試量（包括國際測試量）的主要驅動力，從去年同期的 9,649 次測試增加到 15,072 次測試，增加了 56%。 MRD Pharma 下跌 4%，本季沒有實現任何里程碑。免疫醫學收入為 1,330 萬美元，比去年同期下降 52%，其中 85% 的下降是由基因泰克攤銷額下降造成的。免疫醫學製藥服務較前一年下降 29%，也面臨來自生物製藥的下行壓力。

Moving down to P&L on Slide 8. Total gross margin for the quarter was 49%. The decline in gross margin versus the prior year was largely attributable to lower amortization of the Genentech upfront, which is 100% margin contribution and incremental onetime costs from the lab move. Versus the second quarter, the decline was mainly driven by no milestones compared to the Genentech milestone we realized last quarter in addition to product mix tied to reduced pharma services and incremental costs from completion of the lab move. We continue to focus on optimizing operations to further enhance margins. This includes the implementation of a new LIMS ecosystem by mid-2024, which will allow us to reduce overhead and increase the productivity of direct labor in the lab.

轉到投影片 8 上的損益表。該季度的總毛利率為 49%。毛利率較前一年下降的主要原因是基因泰克預付款攤提減少，即 100% 的利潤貢獻和實驗室搬遷帶來的增量一次性成本。與第二季度相比，下降的主要原因是與我們上季度實現的基因泰克里程碑相比沒有里程碑，此外還有與製藥服務減少和實驗室搬遷完成帶來的成本增量相關的產品組合。我們繼續專注於優化營運以進一步提高利潤率。這包括在 2024 年中期實施新的 LIMS 生態系統，這將使我們能夠減少開銷並提高實驗室直接勞動力的生產力。

In addition, after completing a technical feasibility review, we'll be switching from NextSeq to NovaSeq sequencers next year. We expect completion by late 2024, bringing significant savings in material costs in 2025. Importantly, other OpEx, excluding cost of revenue declined 11% versus the prior year and 12% versus the prior quarter as we continue to be laser-focused on driving operating leverage and efficiencies across the organization.

此外，在完成技術可行性審查後，我們將於明年從 NextSeq 定序儀切換到 NovaSeq 定序儀。我們預計將於 2024 年底完工，從而在 2025 年大幅節省材料成本。重要的是，由於我們繼續專注於推動運營，其他運營支出（不包括收入成本）同比下降 11%，環比下降 12%整個組織的影響力和效率。

Interest expense from our royalty financing agreement with OrbiMed was $3.7 million, which was offset by interest and other income of $4.3 million. Net loss for the quarter was $50.3 million compared to $45.3 million last year. We ended the quarter with approximately $371 million in cash, equivalents and marketable securities.

我們與 OrbiMed 的特許權使用費融資協議產生的利息費用為 370 萬美元，被利息和其他收入 430 萬美元抵銷。本季淨虧損為 5,030 萬美元，去年同期淨虧損為 4,530 萬美元。本季末，我們擁有約 3.71 億美元的現金、等價物和有價證券。

Now turning to updated guidance on Slide 9. As Chad mentioned, given the ongoing strategic review, we are updating total company revenue guidance for 2023 to exclude Immune Medicine revenue. Going forward, Immune Medicine will resemble a more traditional drug discovery biotech model and we want to ensure that we do not trade off short-term revenues for long-term value. And accordingly, we will not be providing revenue guidance for that business going forward.

現在轉向幻燈片 9 上的更新指導。正如 Chad 所提到的，考慮到正在進行的策略審查，我們正在更新 2023 年公司總收入指導，以排除免疫醫學收入。展望未來，免疫醫學將類似於更傳統的藥物發現生物技術模型，我們希望確保我們不會為了長期價值而犧牲短期收入。因此，我們將不會為該業務提供未來的收入指導。

For MRD, we continue to expect clonoSEQ test volumes to grow over 50% for the full year versus 2022. ASPs in the fourth quarter are expected to grow mid-single digits sequentially. We expect pharma services to continue experiencing downward pressure from biopharma industry spending in the fourth quarter, and MRD milestones are expected to be in the low single digits. Putting it together, we expect total MRD revenue for 2023 to be in the range of $100 million to $105 million.

對於 MRD，我們繼續預期 clonoSEQ 全年測試量將比 2022 年成長 50% 以上。第四季的 ASP 預計將連續成長中個位數。我們預計第四季度製藥服務將繼續面臨生物製藥行業支出的下行壓力，而 MRD 里程碑預計將處於較低的個位數。綜上所述，我們預計 2023 年 MRD 總收入將在 1 億至 1.05 億美元之間。

As we continue to drive operating efficiencies, our total company full year OpEx target, including cost of revenue, is expected to be around $375 million, a decrease of approximately 3% from last year. Cash burn for the third quarter was $46 million and higher than anticipated due to lower pharma service revenues, but we expect the 4Q burn to be more normalized at around $35 million. Q3 had important achievements in both businesses, and we remain focused on driving execution while managing our spending prudently as we close the year and complete the strategic review. I'll now turn the call back over to Chad.

隨著我們繼續提高營運效率，我們公司全年整體營運支出目標（包括收入成本）預計約為 3.75 億美元，比去年下降約 3%。由於製藥服務收入下降，第三季的現金消耗為 4,600 萬美元，高於預期，但我們預計第四季度的現金消耗將更加正常化，約為 3,500 萬美元。第三季這兩項業務都取得了重要成就，在年底並完成策略審查時，我們仍然專注於推動執行，同時審慎管理支出。我現在將把電話轉回乍得。

Thanks, Tycho. I am confident in the potential value of MRD and Immune Medicine, and we look forward to arriving in an optimal outcome that maximizes each business to best serve our patients and our shareholders. With that, I'd like to turn the call back over to the operator and then open up for questions.

謝謝，第谷。我對 MRD 和免疫醫學的潛在價值充滿信心，我們期待達到最佳結果，最大限度地發揮每項業務的優勢，為我們的患者和股東提供最佳服務。這樣，我想將電話轉回接線員，然後再提出問題。

(Operator Instructions) And our first question today comes from the line of Mark Massaro with BTIG.

（操作員說明）今天我們的第一個問題來自 BTIG 的 Mark Massaro。

The first one is just, I guess, why now? I think there's been some discussion about synergies or lack thereof of the 2 businesses. Just curious why you're conducting this formal strategic review at this time? And maybe just any comments you have about the 2 businesses? And should we read into this that there are just not parallel synergies between the two?

我想第一個就是為什麼是現在？我認為已經有一些關於這兩家公司是否存在協同效應的討論。只是好奇為什麼你在這個時候進行正式的策略審查？也許您對這兩家企業有什麼評論？我們是否應該理解這兩者之間並不存在平行的協同作用？

Yes. Thanks, Mark. And we have been talking for the last 18 months about having 2 distinct business opportunities. And we are evaluating all options with our partners at Goldman Sachs to maximize the value of both businesses. Really, it's a fact that we have 2 distinct businesses, and they're at different stages of maturity. They have different value drivers and they also have different investment requirements. I mean if you look at the MRD business, I mean clonoSEQ, it's a commercial stage diagnostic business. It's the gold standard in MRD. But that business is -- it's all about execution. And on the top line, we got to drive volumes, increase ASPs.

是的。謝謝，馬克。過去 18 個月我們一直在談論兩個不同的商業機會。我們正在與高盛的合作夥伴一起評估所有選擇，以最大限度地提高兩家公司的價值。事實上，我們有兩個不同的業務，而且它們處於不同的成熟階段。他們有不同的價值驅動因素，也有不同的投資需求。我的意思是，如果你看看 MRD 業務，我指的是 clonoSEQ，它是一個商業階段的診斷業務。這是 MRD 的黃金標準。但這項業務的關鍵在於執行。最重要的是，我們必須提高銷售量、提高平均售價。

And on the cost side, it's about bringing down the cost of goods sold and achieving scale to get to profitability by 2025. But IM is a very different business. It's a very different business model. It's much more akin to a traditional biotech business or therapeutics business. The business takes more time. It's really valued on its high -- it has very high potential, but revenue at present isn't the driver. It's about generating data. It's about developing assets and going through clinical trials and really about showing additional proof points that are milestone and catalyst driven. And it's been -- it's become increasingly clear where each business is, it's really the natural point to look at a separation as MRD has now kind of achieved that scale. And at the same time, we've had really what we consider a really nice breakthrough discovery in our platform in MS that we think is going to apply to multiple other kind of autoimmune disorders. So now is the time, and we're ready to go.

在成本方面，目標是降低銷售成本並實現規模化，以便在 2025 年實現盈利。但 IM 是一項非常不同的業務。這是一種非常不同的商業模式。它更類似於傳統的生物技術業務或治療業務。生意需要更多的時間。它的估值確實很高——它具有非常高的潛力，但目前的收入並不是驅動因素。這是關於生成數據的。這是關於開發資產和進行臨床試驗，實際上是關於展示里程碑和催化劑驅動的額外證據點。每個業務的定位已經變得越來越清晰，考慮分離確實是很自然的事情，因為 MRD 現在已經達到了這樣的規模。同時，我們在多發性硬化症平台上確實取得了我們認為非常好的突破性發現，我們認為這將適用於多種其他類型的自體免疫疾病。現在是時候了，我們準備好了。

Okay. Great. So obviously, I understand they require different capital needs and investment. But as for why you're choosing to withdraw the Immune Medicine business from your guidance, I guess, can you maybe peel the onion back a little bit as for that reason.

好的。偉大的。顯然，我了解他們需要不同的資本需求和投資。但至於您為什麼選擇從您的指導中撤回免疫醫學業務，我想，您是否可以將洋蔥剝開一點，因為這個原因。

Yes. A lot of it is because if you look at kind of MRD, which has a kind of very known trajectory. What we don't want to do, it's really a different story in Immune Medicine where we don't want to trade off or mortgage kind of the short term for long-term value creation. There are a number of deals which we could do that we want to make sure that we're doing in the right context to really maximize the potential kind of for the long-term value of that business. And in some sense, like being forced to do deals under kind of certain time pressures and constraints, would I think give away value that would [inure to] the -- our shareholders.

是的。很大程度上是因為如果你看 MRD，它有一個眾所周知的軌跡。我們不想做的，在免疫醫學領域確實是一個不同的故事，我們不想為了長期價值創造而進行短期的權衡或抵押。我們可以做很多交易，我們希望確保我們在正確的背景下進行，以真正最大化該業務的長期價值的潛力。從某種意義上說，就像被迫在一定的時間壓力和限制下進行交易一樣，我認為會放棄對我們的股東有利的價值嗎？

Okay. Great. And last one for me. I might have missed it, but can you just walk through the split between MRD revenue from clinical versus pharma? Obviously, you talked about the pharma having some headwinds. But -- and you certainly maintained your volume guide for 50% for the year. But maybe just any additional clarity on how you're thinking about the clinical versus pharma breakout.

好的。偉大的。最後一張給我。我可能錯過了，但您能簡單介紹一下臨床與製藥的 MRD 收入之間的分配情況嗎？顯然，您談到了該製藥公司面臨的一些阻力。但是——你今年的交易量指導值確實維持在 50%。但也許只是進一步澄清您如何看待臨床與製藥突破。

Yes. So I mean just for -- you're asking on the breakout in the third quarter or what we're expecting for the fourth quarter?

是的。所以我的意思是 - 您是在問第三季的突破還是我們對第四季的預期？

Fourth would be great, but I'll take either.

第四個就很好了，但我會選其中一個。

Yes. I mean, look, the clinical business, if you kind of looked -- so we didn't have any milestones there, right? If you kind of look at U.S. clonoSEQ, it's about a 60-40 split overall, is kind of the right math for this quarter between clinical and pharma. We mentioned pharma was down a little bit sequentially versus the second quarter. Clinical volumes had a nice sequential step-up. And then for the fourth quarter it should be similar, kind of 60-40 split.

是的。我的意思是，看，臨床業務，如果你看的話——那麼我們在那裡沒有任何里程碑，對吧？如果你看美國的 clonoSEQ，你會發現總體上的比例約為 60-40，這是本季臨床和製藥領域的正確計算結果。我們提到製藥業與第二季相比略有下降。臨床卷有一個很好的連續提升。第四節的比數應該是類似的，大概是 60-40 的比數。

And your next question comes from the line of Dan Brennan with TD Cowen.

你的下一個問題來自 Dan Brennan 和 TD Cowen 的對話。

Maybe the first one, just on the strategic review. Looks like there's a lot of options on the table. Is the idea that the Immune Medicine business, you'll look to sell that. Could that business come out as a stand-alone business and trade publicly? Or is there a potential that both businesses get sold? I'm just trying to think through, obviously, the press release discusses strategic options, things are on the table. Just what are the permeations that are being considered?

也許是第一個，只是關於策略審查。看起來桌面上有很多選擇。免疫醫學業務的想法是，你會尋求出售它。該業務能否作為獨立業務並公開交易？或者這兩家公司有可能被出售嗎？我只是想仔細考慮一下，顯然，新聞稿討論了戰略選擇，事情已經擺在桌面上了。正在考慮的滲透到底是什麼？

Yes. Thanks, Dan. We are evaluating. All options are all on the table that we think can maximize value. Obviously, we can't comment on any M&A at this time. All we can say -- I mean, if you look at MRD, it's a differentiated business with a clear category-leading position with real strategic value. And so that provides us a range of viable options to pursue. The same thing on the Immune Medicine business. We think we've got some very differentiated targets and are moving forward. And those could be stand-alone businesses and do very well as stand-alone publicly traded companies. But again, all options are on the table right now.

是的。謝謝，丹。我們正在評估。我們認為可以實現價值最大化的所有選項都已擺在桌面上。顯然，我們目前無法對任何併購發表評論。我們只能說——我的意思是，如果你看看 MRD，你會發現它是一項差異化業務，具有明確的類別領先地位，具有真正的策略價值。這為我們提供了一系列可行的選擇。免疫醫學業務也是如此。我們認為我們已經有了一些非常不同的目標並且正在向前邁進。這些可能是獨立的企業，並且作為獨立的上市公司表現得非常好。但同樣，所有選擇現在都擺在桌面上。

Are there things without Immune Medicine on the MRD side that you guys would do differently in terms of you want to get the profitability? The balance sheet is in good shape. I don't know what -- but in terms of maybe you'd want to be more aggressive, maybe you'd want to get more scale, maybe you want to add in other businesses. I don't -- when you think about MRD on its own operating like other -- strategically, how does that business look on its own?

如果沒有 MRD 方面的免疫醫學，你們會採取不同的做法來獲得獲利嗎？資產負債表狀況良好。我不知道是什麼——但也許你想要更加積極進取，也許你想要擴大規模，也許你想要增加其他業務。我不知道——當你考慮 MRD 像其他公司一樣獨立運作時——策略性地，該業務本身看起來如何？

Yes. It's -- that's a really great question. And actually, if you kind of peel back the onion a little bit to use your term, one of the main reasons we're doing this is really that we have dedicated focus to kind of -- on each one of the businesses. So there's -- what we've found kind of over the last kind of 18 months or so is there's been kind of a competition for resources, software is a good example there. Competition for resources, competition kind of for mindshare, et cetera. So there are ways that we could potentially accelerate on the top line in MRD. And at the same time, I think there are additional ways that we can have kind of operating leverage in the model, and that is certainly something we would kind of look to achieve by looking at these as a stand-alone business.

是的。這是一個非常好的問題。事實上，如果你把洋蔥剝開一點來使用你的術語，我們這樣做的主要原因之一實際上是我們專注於每一項業務。因此，我們在過去 18 個月左右的時間裡發現，存在著某種資源競爭，軟體就是一個很好的例子。資源競爭、思想份額競爭等等。因此，我們可以採取一些方法來加速 MRD 的營收成長。同時，我認為我們還可以透過其他方式在模型中擁有某種營運槓桿，這當然是我們希望透過將這些視為獨立業務來實現的目標。

Maybe I'll sneak one more in. Just in terms of you discussed pricing and the benefits there. Could you just give us a sense of where pricing could head to with all the initiatives that you're making on the clonoSEQ side?

也許我會再偷偷地講一下。就您討論的定價和好處而言。您能否讓我們了解一下您在 clonoSEQ 方面採取的所有舉措的定價走向？

I can just touch on the third quarter and then maybe I'll hand it over. But we ended up just north of $1,000. September was the highest month I can say, based on trends in October, we're confident fourth quarter is going to see this mid-single-digit increase that we mentioned in the prepared comments. So the initiatives that we've implemented are working. But Susan, do you want to maybe touch on that a little more?

我可以簡單談談第三季度，然後也許我會把它移交。但我們最終只賺到了 1,000 美元以上。 9 月是我可以說的最高月份，根據 10 月的趨勢，我們有信心第四季度將看到我們在準備好的評論中提到的中個位數增長。因此，我們實施的措施正在發揮作用。但是蘇珊，你想再談一下這個問題嗎？

Yes. We certainly see the opportunity for continued ASP increases and frankly, acceleration in the growth of ASP in 2024 and beyond. The ASP plan that Chad alluded to is focused again on coverage expansion, growth in contracted lives, shift in our payer mix and operational enhancements to improve collections. We've undertaken already a number of initiatives with -- aligned to those categories, and we have quite a few more planned for launch in January and beyond.

是的。我們當然看到了平均售價持續成長的機會，坦白說，2024 年及以後平均售價將加速成長。乍得提到的 ASP 計劃再次專注於覆蓋範圍擴大、合約壽命增長、付款人結構的轉變以及改善收款的營運增強。我們已經採取了許多與這些類別一致的舉措，我們還計劃在一月份及以後推出更多舉措。

And through that, we expect to see an acceleration of the growth rate on ASP in 2024. And beyond that, we're not providing specific guidance, but we do certainly see potential for continued improvements.

由此，我們預計 2024 年 ASP 成長率將加快。除此之外，我們不會提供具體指導，但我們確實看到了持續改善的潛力。

Maybe I'll sneak a final one in, sorry. MRD for '24, any early look, I mean, pharma is so uncertain. You've called it out, others have called it out, but maybe we're hopefully near bottom here. Just any early way to think about '24 on the MRD side of the business?

也許我會偷偷地放最後一張，抱歉。 24 年的 MRD，任何早期的觀察，我的意思是，製藥業是如此不確定。你已經指出了這一點，其他人也已經指出了這一點，但也許我們已經接近底部了。有什麼早期的方式來考慮 '24 在 MRD 方面的業務嗎？

Yes. We're not providing specific guidance yet for '24. I do -- I can tell you though, from the clinical business standpoint, we continue to see not only the ASP growth that Tycho and Susan just alluded to, but our volumes continue to grow, and we do expect another great year in terms of volume growth in 2024.

是的。我們尚未提供 '24 的具體指導。我確實- 我可以告訴你，從臨床業務的角度來看，我們不僅繼續看到第谷和蘇珊剛才提到的平均售價增長，而且我們的銷量繼續增長，我們確實預計又一個偉大的一年2024 年銷量成長。

It might be worth mentioning, we also had a significant backlog in MRD pharma, $190 million. So that bodes well for the future health of the business.

值得一提的是，我們在 MRD Pharma 方面也有大量積壓訂單，價值 1.9 億美元。因此，這對企業未來的健康發展來說是個好兆頭。

And our next question comes from the line of Rachel Vatnsdal with JPMorgan.

我們的下一個問題來自 Rachel Vatnsdal 與摩根大通的關係。

This is [Noah] on for Rachel. Just reframing some of the topics you've touched on here a little bit more specifically. I understand you're refocusing here on the MRD business. Can you give us a sense of the levers you can possibly pull to continue protecting and strengthening the balance sheet? It seems like the quarter had some decent bright spots. For example, excluding some onetime costs in the lab move completion, gross margins in 3Q were 55% versus that 49%. And then also, you've noted here at conferences that the switch from the NextSeq to the NovaSeq X project is ongoing, it could be a meaningful cost saver. So could you give us any sort of quantitative sense as to how much some of these cost-saving mechanisms could protect your margins and manage your cash burn? Heading into next year, assuming we're just looking at the MRD business? And then if you want to loop in any updated thoughts and remind us of how that OrbiMed deal could play into that. And I have additional follow-ups.

這是瑞秋的[諾亞]。只是更具體地重新定義您在這裡提到的一些主題。我了解您正在重新關注 MRD 業務。您能否讓我們了解您可以利用哪些槓桿來繼續保護和強化資產負債表？該季度似乎有一些不錯的亮點。例如，排除實驗室搬遷完成過程中的一些一次性成本，第三季的毛利率為 55%，而去年同期為 49%。此外，您在會議上註意到，從 NextSeq 到 NovaSeq X 專案的轉換正在進行中，這可能會節省大量成本。那麼，您能為我們提供一些定量的資訊嗎？這些成本節約機制可以在多大程度上保護您的利潤並管理您的現金消耗？進入明年，假設我們只專注於 MRD 業務？然後，如果您想循環播放任何最新的想法，並提醒我們 OrbiMed 交易將如何發揮作用。我還有其他後續行動。

Sure. Noah. Good to hear from you. So a couple of thoughts on margins this quarter. Milestones are a big factor. It's coming -- come in 100%. We didn't have any milestones this quarter. So that did weigh a little bit on margins. We had lower Genentech amortization also impacted us. But importantly, we finalized the lab move, and that did have some onetime costs in the quarter.

當然。諾亞。很高興聽到你的消息。關於本季利潤率的一些想法。里程碑是一個重要因素。它來了——100%到來。本季我們沒有任何里程碑。所以這確實對利潤率造成了一些影響。我們的基因泰克攤銷率較低也對我們產生了影響。但重要的是，我們最終完成了實驗室搬遷，這在本季確實產生了一些一次性成本。

If you exclude the lab move costs, gross margins were closer to 55%. So just looking at it a little bit sequentially, the Genentech milestone we saw in the second quarter was $7.5 million. Again, no milestone in the third quarter. There was some product mix impact, pharma services is higher margin. And as we discussed on the call, that's lower than expected. Going forward, we're fairly comfortable that, that business at scale is a 70-plus percent margin business. And we've got a number of initiatives. We've got a LIMS overhaul we talked about. There will be labor and workforce efficiencies on the back of that. You mentioned the switch to NovaSeq. That really will benefit us in 2025. We'll kind of implement it in the latter part of 2024, but I would really think about that contributing in 2025. Like other CLIA lab businesses, 70-plus percent at scale is easily doable for our business overall.

如果排除實驗室搬遷成本，毛利率接近 55%。因此，只要按順序看一下，我們在第二季度看到的 Genentech 里程碑是 750 萬美元。同樣，第三季沒有里程碑。產品組合受到一些影響，製藥服務的利潤率較高。正如我們在電話中討論的那樣，這低於預期。展望未來，我們對大規模業務的利潤率達到 70% 以上感到相當滿意。我們已經採取了許多措施。我們已經討論過 LIMS 檢修。在此基礎上將會提高勞動力和勞動力效率。您提到了轉向 NovaSeq。這確實會讓我們在2025 年受益。我們將在2024 年下半年實施它，但我真的會考慮在2025 年做出貢獻。與其他CLIA 實驗室業務一樣，70% 以上的規模對於我們來說是很容易實現的業務整體。

Yes. The other thing is we -- as we move labs from one building to another, we continue to look at the real estate portfolio, and we're looking at ways to kind of offload one of our buildings as well, which will provide kind of additional leverage.

是的。另一件事是我們——當我們將實驗室從一棟大樓搬到另一棟大樓時，我們繼續關注房地產投資組合，我們也在尋找方法來卸載我們的一棟大樓，這將提供一種額外的槓桿。

And we think the MRD business -- Noah, just the one follow-up. You asked on MRD, specifically, we think that business can be profitable in 2025.

我們認為 MRD 業務－Noah，只是後續行動。你問到MRD，具體來說，我們認為業務可以在2025年實現盈利。

That was my next question. So I was just thinking like if we're looking at just the core MRD business, like -- do you think -- yes, so would you like to sort of talk about the hitting potential growth rates of like the 2022 to the 2027 revenue CAGR of 20 to 30? Or the EBITDA margin breakeven in 2025 or cash flow breakeven in 2026 on just the core MRD business? And then I have one last one.

這是我的下一個問題。所以我只是在想，如果我們只專注於核心 MRD 業務，你認為嗎？是的，那麼你想談談 2022 年到 2027 年收入的潛在成長率嗎？複合年增長率為 20 至 30？或僅核心 MRD 業務在 2025 年達到 EBITDA 利潤率損益平衡，或在 2026 年達到現金流損益兩平？然後我還有最後一張。

Yes. I mean, again, we think MRD can be profitable in 2025. We've kind of given you a number of the components around how we're thinking about ASPs increasing and then volume growth over 50% this year. And it should be sustainable, law of larger numbers obviously start to factor in as you get further out, but we're very comfortable that this will continue to be high in the double digits in terms of volume growth overall.

是的。我的意思是，我們認為 MRD 可以在 2025 年實現盈利。我們已經向您提供了一些有關我們如何考慮 ASP 增長以及今年銷量增長超過 50% 的信息。而且它應該是可持續的，隨著你走得更遠，大數法則顯然開始考慮在內，但我們非常滿意，就總體銷量增長而言，這將繼續保持兩位數的高增長。

Awesome. Okay. And then related to that, like law of large numbers thing, can you talk about if you thought about any of the closest core MRD adjacencies that maybe you could move into or pull forward, some of the investment in those to be in the near term as part of your like overall TAM story? Maybe not officially areas that you're definitively going into, but maybe some areas you've considered as potential portfolio adjacencies that could be easy growth drivers as we sort of think about refreshing the long-term growth story here.

驚人的。好的。然後與此相關，例如大數定律，您能否談談您是否考慮過可能會進入或推進的任何最接近的核心 MRD 鄰域，以及近期對這些鄰域的一些投資作為您整個TAM 故事的一部分？也許不是您最終要進入的正式領域，但也許您認為某些潛在的投資組合相鄰領域可能是簡單的成長驅動力，因為我們有點考慮刷新這裡的長期成長故事。

Susan, do you want to take that?

蘇珊，你想要那個嗎？

Sure. We have looked at a number of adjacencies. I mean, first and foremost, the most obvious ones are other lymphoid malignancies in which we have not commercialized the assay, so additional non-Hodgkin's lymphoma indications in particular. And we do have plans in place to move forward with commercialization, including securing reimbursement from Medicare and private payers over the next couple of years.

當然。我們已經研究了許多鄰接關係。我的意思是，首先也是最重要的是，最明顯的是我們尚未將檢測方法商業化的其他淋巴惡性腫瘤，因此特別是其他非何杰金氏淋巴瘤適應症。我們確實制定了推進商業化的​​計劃，包括在未來幾年內確保醫療保險和私人付款人的報銷。

Additionally, there are adjacencies in the myeloid malignancies and perhaps in other tumors. At this time, we are exploring opportunities in the myeloid space, very early stages to understand the feasibility of particular technologies and the opportunity. And then in the solid tumor space, we have done some review but have no plans at this time.

此外，骨髓惡性腫瘤以及其他腫瘤中也可能有鄰近現象。目前，我們正在早期階段探索骨髓空間的機會，以了解特定技術的可行性和機會。然後在實體瘤領域，我們已經做了一些審查，但目前還沒有計劃。

And our next question comes from the line of Tejas Savant.

我們的下一個問題來自Tejas Savant。

This is Edmund on for Tejas. I just wanted to touch upon the Epic EMR integration. With some of your pilot sites now live, I know you guys have talked about volume contributions really inflecting in 2024. But what have you seen so far in terms of volume inflection at these sites?

我是埃德蒙 (Edmund) 代表光輝號 (Tejas) 發言。我只是想談談 Epic EMR 整合。隨著你們的一些試點站點現已上線，我知道你們已經談到了 2024 年銷量貢獻的真正變化。但是到目前為止，你們在這些站點的銷量變化方面看到了什麼？

Sure. Thanks for the question, Edmund. We only have 1 site live as of today and not quite 2 months of experience with that site. But what I can say is that we have seen growth in that account in that short time, both in HCP users as well as in volumes. And additionally, that site's positive feedback has led them to expand the scope of the integration previously limited to the outpatient setting, now expanding to inpatient and including the potential to place standing orders, which are new features they've added since the initial go live.

當然。謝謝你的提問，埃德蒙。截至今天，我們只有 1 個網站，而且網站的使用時間不到 2 個月。但我可以說的是，我們在短時間內看到該帳戶的成長，無論是 HCP 用戶還是數量。此外，該網站的正面回饋促使他們擴大了以前僅限於門診環境的整合範圍，現在擴展到住院病人，並包括下定期訂單的可能性，這是他們自最初上線以來添加的新功能。

We have 4 more sites scheduled to go live by the end of this year. So we'll be able to start getting more robust, albeit still anecdotal evidence to support our understanding of how Epic may contribute to growth in 2024 and beyond. And again, we expect to have as many as 25 sites lagged by the end of '24, at which point, I think we'll be more well positioned to comment on likely growth opportunities. But we do expect lift from Epic, other companies who have implemented Epic have seen lift and we'll be eager to comment further when we have a little more evidence.

我們還有 4 個站點計劃在今年年底上線。因此，我們將能夠開始獲得更強有力的（儘管仍然是軼事證據）來支持我們對 Epic 如何為 2024 年及以後的成長做出貢獻的理解。再說一遍，我們預計到 24 年底將有多達 25 個網站落後，屆時，我認為我們將更有能力對可能的成長機會發表評論。但我們確實預期 Epic 會帶來提升，其他實施了 Epic 的公司也看到了提升，當我們有更多證據時，我們將渴望進一步發表評論。

Got it. That was super helpful. And then just wanted to clarify, I think you guys have just commented that you anticipate about $190 million in backlog by year-end for the trial side of the business. What are your expectations between on mix between pharma and SMIDs and the backlog and between retrospective and prospective trial mix.

知道了。這非常有幫助。然後我想澄清一下，我想你們剛剛評論說，預計到年底，業務試用方面的積壓金額約為 1.9 億美元。您對製藥公司和 SMID 之間的混合、積​​壓以及回顧性和前瞻性試驗混合之間的期望是什麼。

So you said between pharma and what?

所以你說的是製藥和什麼？

It's small caps...

是小大寫的...

SMID caps, [biotech] caps.

SMID 帽、[生技] 帽。

Got it. Sorry. Well, I can't comment that the majority of new studies that we book. When you asked about prospective and [at least our perspective], the majority are prospective studies, and we expect that to continue to be a case.

知道了。對不起。好吧，我無法評論我們預訂的大多數新研究。當您詢問前瞻性研究和[至少我們的觀點]時，大多數都是前瞻性研究，我們預計這種情況將繼續存在。

Yes. We don't have a mix, but I will also say kind of the majority of our client profile is kind of large cap pharma and not SMIDs and small cap, although we certainly do have kind of a -- I would say, kind of, call it, 15% to 20% that you would kind of traditionally classify as SMIDs, but the majority are large pharma.

是的。我們沒有混合，但我也會說，我們的大多數客戶資料都是大型製藥公司，而不是 SMID 和小型製藥公司，儘管我們確實有某種 - 我會說，有點傳統上將15% 到20%歸類為SMID，但大多數是大型製藥公司。

Got it. And then with the ASH conference just around the corner in December, are there some key publications, presentations or data points that we should be watching out for?

知道了。隨著 12 月 ASH 會議的臨近，是否有一些我們應該關注的重要出版物、簡報或數據點？

Yes, indeed. In particular, we are excited about some data that's going to be presented by investigators from University of Chicago on the use of our assay in blood. So in this particular study, clonoSEQ was used at early time points during first-line therapy in multiple myeloma to assess response in both blood and bone marrow, and to compare that assessment to the commonly used serum biochemical markers that are part of traditional myeloma response assessment criteria.

確實是的。特別是，我們對芝加哥大學研究人員將提供的有關我們的血液檢測方法使用的一些數據感到興奮。因此，在這項特定研究中，在多發性骨髓瘤一線治療期間的早期時間點使用 clonoSEQ 來評估血液和骨髓的反應，並將該評估與作為傳統骨髓瘤反應一部分的常用血清生化標記物進行比較評估標準。

The study will show that clonoSEQ in blood is strongly prognostic of outcomes and provides greater insight than traditional blood-based markers. And the authors have suggested in the abstract, which is now available publicly, that the insights that have just been gained from this work could be useful in the future as validated to inform treatment intensification in MRD-positive myeloma patients.

該研究將表明，血液中的 clonoSEQ 對結果有很強的預測作用，並且比傳統的基於血液的標記物提供了更深入的見解。作者在現已公開的摘要中表示，剛從這項工作中獲得的見解在經過驗證後可能會在未來有用，為 MRD 陽性骨髓瘤患者的治療強化提供資訊。

So we expect to leverage that data to advance the adoption of our blood-based testing in myeloma by using it to help guide use of interim blood-based testing as a complement to marrow, and by showcasing the favorable prognostic comparison when you measure early response with clonoSEQ in blood versus serum biomarkers in blood.

因此，我們希望利用這些數據來推動基於血液的檢測在骨髓瘤中的採用，利用它來幫助指導使用臨時基於血液的檢測作為骨髓的補充，並在測量早期反應時展示有利的預後比較血液中的clonoSEQ 比較血液中的血清生物標記。

(Operator Instructions) And our next question comes from the line of Salveen Richter with Goldman Sachs.

（操作員說明）我們的下一個問題來自高盛的 Salveen Richter。

This is Livia on for Salveen. So we just have one on the Immune Medicine business. You noted that a novel target has been identified in MS. So what are the next steps for this program and what is the path to monetization here? And then can you just discuss the forward growth outlook for this business more broadly?

我是薩爾文的莉維亞。所以我們只有免疫醫學業務方面的一個。您注意到在 MS 中已經確定了一個新標靶。那麼這個計畫的下一步是什麼？貨幣化的途徑是什麼？然後您能否更廣泛地討論該業務的未來成長前景？

Yes. Sharon, I will turn it over to you to answer that.

是的。莎倫，我將把它交給你來回答。

Thanks for the question. So yes, we're excited, as we mentioned. We've been focusing on identifying novel targets in autoimmunity and multiple sclerosis is the first lead program where we've identified that novel target. We're actively confirming and continuing to validate both in in vitro and in vivo MS disease models and ultimately building out a preclinical package to drive the target. So that's in MS. And now that we've unlocked and proven out this approach in MS, of course, in parallel, our pipeline includes other autoimmune disorders. And our goal overall is, of course, to eventually be able to bring therapies against these targets into the clinic, either on our own or with a partner.

謝謝你的提問。所以，是的，正如我們所提到的，我們很興奮。我們一直致力於確定自體免疫的新標靶，多發性硬化症是我們確定該新標靶的第一個主導項目。我們正在積極確認並繼續驗證體外和體內多發性硬化症疾病模型，並最終建立一個臨床前方案來驅動目標。這就是 MS 中的情況。現在我們已經在多發性硬化症中解鎖並證明了這種方法，當然，同時，我們的管道還包括其他自體免疫疾病。當然，我們的總體目標是最終能夠將針對這些目標的療法引入臨床，無論是我們自己還是與合作夥伴。

And our next question comes from the line of David Westenberg with Piper Sandler.

我們的下一個問題來自大衛·韋斯特伯格和派珀·桑德勒的對話。

So just had a question on the Immune Medicine business in terms of inbound interest or conversations that you've had with what could be considered strategic partners, but maybe could be customers right now? Like have they desired any kind of like exclusivity on certain kinds of work you've done [for them] or any other kind of inbound or strategic conversations you've had? I know that some of that is sensitive, but any kind of color there would be great.

因此，我對免疫醫學業務有一個疑問，即您與哪些可以被視為策略夥伴（但現在可能是客戶）的入站興趣或對話？就像他們是否希望對您[為他們]所做的某些工作或您進行的任何其他類型的入站或策略對話擁有任何排他性？我知道其中有些是敏感的，但任何顏色都會很棒。

David, the only thing I could say at this time is from in the discussions we've had under confidentiality kind of showing the work we've done on the MS target, there is a tremendous amount of excitement to look at ways that we may partner. And as we said, going under a strategic review and part of the kind of rationale for not doing kind of a short-term deal is we're assessing kind of what the optimal partnership is if we go down that route versus kind of developing the asset further ourselves. And so I think just more broadly on the Immune business, whether exclusivity or non-exclusivity, really can't -- not at liberty to comment on specific deal structures at this time.

大衛，此時我唯一能說的是，我們在保密的情況下進行的討論顯示了我們在 MS 目標上所做的工作，我們非常興奮地研究我們可能採取的方法夥伴。正如我們所說，進行策略審查，不達成某種短期協議的部分原因是，我們正在評估如果我們沿著這條路線走下去，而不是發展一種短期協議，那麼最佳的夥伴關係是什麼。資產進一步我們自己。因此，我認為更廣泛地討論免疫業務，無論是排他性還是非排他性，目前都不能自由地對具體交易結構發表評論。

Got you. And sorry if I missed it, I've been in and out of WiFi connection and phone connection. Is there -- was there any kind of data with this -- that we had with the MS? And is there any kind of barometers we should look like in terms of -- I don't even know what they would be quantitatively, like sensitivity specificity? I'm a diagnostic guy. So I do tend to take things that way, but anything we should look for in the data that says this is going to be really, really exciting? Just help us frame that.

明白你了。抱歉，如果我錯過了，我已經斷過 WiFi 連線和電話連線。我們在 MS 上有沒有——有任何類型的數據嗎？我們是否應該有某種晴雨表——我甚至不知道它們的定量是什麼，例如敏感性特異性？我是一名診斷人員。所以我確實傾向於這樣看待事情，但是我們應該在數據中尋找任何表明這將非常非常令人興奮的東西？請幫助我們建立它。

Sharon, if you can kind of take that, that would be great.

莎倫，如果你能接受的話，那就太好了。

Yes, absolutely. So as you can imagine, we have a lot of data, which gives us confidence about the target. We've identified and are continuing to generate that data to further validate including in the preclinical setting. Our plan is to publish on these new findings. Importantly, because of this novel discovery, we've focused and have submitted this quarter a couple of core patent applications that protects our findings in MS, but also cover more broadly on differentiated target discovery approach in autoimmunity. And in addition, this includes also data on potential new T cell biology we've uncovered that informs how, if you will, a revved-up immune system attacks normal healthy cells, and in the case of MS, possibly triggers the disease. So a lot of data forthcoming that we are excited and will share when appropriate.

是的，一點沒錯。正如您可以想像的那樣，我們擁有大量數據，這使我們對目標充滿信心。我們已經確定並正在繼續產生這些數據以進一步驗證，包括在臨床前環境中。我們的計劃是發表這些新發現。重要的是，由於這項新發現，我們在本季度重點關注並提交了幾項核心專利申請，這些專利申請保護了我們在多發性硬化症方面的發現，同時也更廣泛地涵蓋了自身免疫方面的差異化標靶發現方法。此外，這還包括我們發現的潛在新T 細胞生物學數據，如果你願意的話，這些數據可以告訴你，加速的免疫系統如何攻擊正常的健康細胞，就多發性硬化症而言，可能會引發這種疾病。我們對即將出現的大量數據感到興奮，並將在適當的時候分享。

And our final question today comes from the line of Derik De Bruin with Bank of America.

今天我們的最後一個問題來自美國銀行的 Derik De Bruin。

This is [John] on for Derik. A lot has been covered, but wanted to ask on the macro. Great to hear on the bookings. But in terms of the continuing pharma pressure, I was wondering if you think there would be some sort of a budget flush in 4Q and what's your expectation there? And do you see that turning around in the next couple of quarters? Or do you perhaps see that turning around maybe like in the second half of '24.

這是德里克的[約翰]。已經涵蓋了很多內容，但想詢問宏觀問題。很高興聽到預訂情況。但就持續的製藥壓力而言，我想知道您是否認為第四季度會出現某種預算充裕，您對此有何期望？您認為這種情況會在接下來的幾季內出現轉變嗎？或者你會看到，情況可能會像 24 年下半年那樣逆轉。

Yes. Thanks for the question, John. So typically, in Q4, you're right that we do experience higher volumes and revenue as pharma companies flush out their budgets. But that said, given the industry softening we've been observing of late, we don't anticipate as big of a lift this year in Q4. That said, importantly, we still do have a very significant backlog and healthy bookings, and we haven't seen a lot of studies being canceled. So our backlog has grown, and we believe that most of the reprioritization is being completed. So we do expect the higher backlog that we've built, 20% higher than last year, will fuel revenue growth in 2024 and beyond.

是的。謝謝你的提問，約翰。因此，通常情況下，在第四季度，隨著製藥公司削減預算，我們確實會經歷更高的銷售和收入，這是正確的。但話雖如此，鑑於我們最近觀察到的行業疲軟，我們預計今年第四季不會有那麼大的提升。也就是說，重要的是，我們仍然有大量的積壓和健康的預訂，我們沒有看到很多研究被取消。因此，我們的積壓工作增加，我們相信大部分優先順序調整正在完成。因此，我們確實預計，我們已經積壓的訂單量將比去年增加了 20%，這將推動 2024 年及以後的收入成長。

Got you. Appreciate it. And then just wanted to ask you, you've talked about the moving pieces of the ASP. But the long-term target of $1,600 in 2027, is that -- does that still stand?

明白你了。欣賞它。然後我想問一下您，您談到了 ASP 的移動部分。但 2027 年 1,600 美元的長期目標仍然有效嗎？

Yes, we're confirming kind of the long-term targets and are making great strides to get there.

是的，我們正在確認某種長期目標，並正在為實現這一目標取得重大進展。

Thank you. Operator, are there any other questions?

謝謝。接線員，還有其他問題嗎？

My apologies, it would help if I would talk unmuted. No, there are no further questions. Did you have any closing remarks, folks?

抱歉，如果我不靜音說話會有幫助。不，沒有其他問題了。各位，您有結束語嗎？

Well, thank you for joining the call.

好的，感謝您加入通話。

Thank you. And ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect. Have a great day, everyone.

謝謝。女士們、先生們，今天的電話會議到此結束。感謝大家的加入，現在可以斷開連線了。祝大家有個美好的一天。