Adaptive Biotechnologies Corp (ADPT) 2023 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Adaptive Biotechnologies Second Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Karina Calzadilla Head of Investor Relations.

美好的一天，感謝您的支持。歡迎參加自適應生物技術 2023 年第二季度電話會議。此時，所有參與者都處於只聽模式。演講者演講結束後，將進行問答環節。 （操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的發言人、投資者關係主管卡琳娜·卡爾薩迪拉 (Karina Calzadilla)。

Thank you, Dusinda, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies Second Quarter 2023 Earnings Conference Call. Earlier today, we issued a press release reporting adaptive financial results for the second 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.

謝謝杜辛達，大家下午好。歡迎您參加 Adaptive Biotechnologies 2023 年第二季度收益電話會議。今天早些時候，我們發布了一份新聞稿，報告 2023 年第二季度自適應財務業績。該新聞稿可在 www.adaptivebiotech.com 上獲取。我們正在對本次電話會議進行網絡直播，並將參考已發佈在我們公司網站投資者部分的幻燈片演示。

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，管理層將就聯邦證券法含義內的未來事件和公司未來的財務業績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存在重大差異，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演示文稿中列出的許多因素。

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'll 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。今天加入電話會議的是我們的首席執行官兼聯合創始人查德·羅賓斯 (Chad Robins)；以及我們的首席財務官 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 second quarter 2023 earnings call. As always, I want to thank all of our Adaptive employees for their continued dedication and execution. We're halfway through the year with solid 6 months results and key milestones achieved.

謝謝，卡琳娜。大家下午好，感謝您參加我們的 2023 年第二季度財報電話會議。一如既往，我要感謝所有 Adaptive 員工的持續奉獻和執行力。今年已過半，我們在 6 個月內取得了紮實的成果，並實現了關鍵的里程碑。

As shown on Slide 3, revenue for the quarter was $48.9 million, representing 12% growth versus prior year. This growth reflects strong performance from clonoSEQ clinical testing and the achievement of our first milestone in drug discovery, which more than offset an anticipated reduction in our Genentech amortization.

如幻燈片 3 所示，該季度收入為 4890 萬美元，比去年同期增長 12%。這一增長反映了 clonoSEQ 臨床測試的強勁表現以及我們在藥物發現方面第一個里程碑的實現，這足以抵消我們基因泰克攤銷的預期減少。

Our R&D programs in oncology and autoimmune disorders continue to progress. Both programs in cancer with Genentech are advancing, and we're very pleased to see the IND acceptance for our first candidate in cell therapy. In addition, given our efforts to streamline our organization and improve operating efficiencies, we achieved gross margin improvement of 8 percentage points related to sequencing alone versus prior quarter. We are laser-focused on achieving operating leverage and ensuring our path to profitability with current cash on hand.

我們在腫瘤學和自身免疫性疾病方面的研發項目不斷取得進展。基因泰克的兩個癌症項目都在取得進展，我們很高興看到我們的第一個細胞療法候選藥物獲得 IND 接受。此外，鑑於我們努力精簡組織並提高運營效率，與上一季度相比，僅與測序相關的毛利率就提高了 8 個百分點。我們專注於實現運營槓桿並確保利用現有現金實現盈利。

Earlier today, we announced that Nitin Sood, Head of our MRD business is leaving Adaptive to take a new position and a multinational public company. Susan Bobulsky, who has led the clinical business for the past 5 years, will assume additional responsibilities and report directly to me. I'd like to thank Nitin for his leadership and the important contributions he's made in laying a solid foundation for our MRD business, and we wish him success in his new endeavor.

今天早些時候，我們宣布 MRD 業務主管 Nitin Sood 將離開 Adaptive，前往一家跨國上市公司擔任新職務。過去 5 年領導臨床業務的 Susan Bobulsky 將承擔額外職責並直接向我匯報。我要感謝 Nitin 的領導以及他為我們的 MRD 業務奠定堅實基礎所做出的重要貢獻，我們祝愿他在新的事業中取得成功。

Let's now take a closer look at MRD business on Slide 4. Total MRD for the quarter, including clinical testing and pharma grew 22% versus prior year. On the left side of the slide, you can see strong clonoSEQ clinical volume growth with all metrics trending in the right direction. Test delivered grew 52% year-over-year with double-digit volume growth in all marketed indications. Multi-myeloma continues to be the largest contributor and the main growth driver. Ordering health care providers and ordering accounts grew 44% and 37% versus prior year, respectively.

現在讓我們仔細看看幻燈片 4 上的 MRD 業務。本季度的 MRD 總額（包括臨床測試和製藥）與去年同期相比增長了 22%。在幻燈片的左側，您可以看到 clonoSEQ 臨床數量的強勁增長，所有指標都朝著正確的方向發展。交付的測試量同比增長 52%，所有上市適應症的銷量均實現兩位數增長。多發性骨髓瘤仍然是最大的貢獻者和主要的增長動力。訂購醫療保健提供者和訂購帳戶比去年分別增長了 44% 和 37%。

Blood-based testing increased in all indications and grew 16% sequentially. Now approximately 37% of all MRD tests are in blood. Community accounts, a key factor to accelerate penetration in blood continued its growth trajectory quarter-over-quarter and now contributes 21% of clonoSEQ volume versus 11% a year ago. As shown on the right side of the slide, MRD Pharma grew 14%, excluding regulatory milestones. The slight slowdown in growth this quarter reflects macro factors impacting the broader biopharma industry as trials are getting extended and portfolios reprioritized.

所有適應症的血液檢測均有所增加，環比增長 16%。現在，大約 37% 的 MRD 檢測是在血液中進行的。社區賬戶是加速血液滲透的關鍵因素，繼續保持季度環比增長軌跡，目前佔 clonoSEQ 銷量的 21%，而一年前為 11%。如幻燈片右側所示，不包括監管里程碑，MRD Pharma 增長了 14%。本季度增長略有放緩反映了影響更廣泛生物製藥行業的宏觀因素，因為試驗正在擴大，投資組合也已重新確定優先順序。

That said, strength in bookings reflect healthy demand for the business going forward. Zooming into clonoSEQ test volume on Slide 5. We continue to set record high volumes quarter-over-quarter. This quarter, volume grew 13% sequentially to over 13,660 tests delivered. Our strategy to drive clonoSEQ volume is working, and we reaffirm our commitment to end the year with over 50% volume growth versus 2022. ASPs were impacted in the quarter due to growth in out-of-policy indications and higher Medicaid contribution.

也就是說，預訂量的強勁反映了未來業務的健康需求。放大幻燈片 5 上的 clonoSEQ 測試量。我們繼續創下季度環比的高記錄。本季度，交付量環比增長 13%，達到超過 13,660 次測試。我們推動clonoSEQ 銷量的戰略正在發揮作用，我們重申我們的承諾，即到年底銷量將比2022 年增長50% 以上。由於政策外適應症的增長和醫療補助貢獻的增加，本季度的平均售價受到了影響。

However, we have a targeted ASP plan focused on closing remaining payer contracts and policy gaps as well as increasing resources for claim management to improve collections. We are confident these initiatives will enable reacceleration of ASP growth for the next several years.

然而，我們有一個有針對性的 ASP 計劃，重點是縮小剩餘的付款人合同和保單缺口，以及增加索賠管理資源以改善收款。我們相信，這些舉措將使未來幾年的平均售價重新加速增長。

Related to ongoing initiatives to expand clonoSEQ utilization, Epic integration is progressing well, and we are excited to bring our first pilot sites live this month with additional integration sites to follow. This marks a milestone for our partnership with Epic and demonstrates our commitment to investing in the clonoSEQ customer experience.

與正在進行的擴大 clonoSEQ 利用率的舉措相關，Epic 集成進展順利，我們很高興本月將推出我們的第一個試點站點，隨後還將推出更多集成站點。這標誌著我們與 Epic 合作的一個里程碑，並表明了我們對投資 clonoSEQ 客戶體驗的承諾。

We also continue to expand meaningful data readouts at the ASH conference, particularly highlighting blood-based testing in multiple myeloma. As shown on Slide 6, the final analysis of the MASTER study was presented during the EHA conference in June. This study shows that for patients who discontinued therapy after 2 consecutive negative clonoSEQ tests, over 85% of them in the standard or high-risk category did not progress after a 3-year follow-up data.

我們還在 ASH 會議上繼續擴大有意義的數據讀數，特別強調多發性骨髓瘤的血液檢測。如幻燈片 6 所示，MASTER 研究的最終分析在 6 月份的 EHA 會議上公佈。這項研究表明，對於連續 2 次 clonoSEQ 測試陰性後停止治療的患者，其中超過 85% 的標准或高風險類別患者在 3 年隨訪數據後沒有進展。

These data have been very well received by physicians and are driving adoption of clonoSEQ for making critical therapy decisions for patients. In summary, the setup for MRD is strong in both clinical testing and pharma, and we look forward to continuing to fuel its growth.

這些數據得到了醫生的廣泛認可，並推動了 clonoSEQ 的採用，為患者做出關鍵的治療決策。總之，MRD 在臨床測試和製藥方面的設置都很強大，我們期待繼續推動其增長。

Switching to our immune medicine business on Slide 7. We generated $23 million in revenue this quarter from Drug Discovery and Pharma Services with drug discovery contributing more than 75% of the revenue. Our IM Pharma services business was impacted this quarter by macro factors affecting the broader biopharma industry, including strategic and/or budget reprioritization.

切換到幻燈片 7 上的免疫醫學業務。本季度我們從藥物發現和製藥服務中獲得了 2300 萬美元的收入，其中藥物發現貢獻了超過 75% 的收入。我們的 IM 製藥服務業務本季度受到影響更廣泛的生物製藥行業的宏觀因素的影響，包括戰略和/或預算的優先順序調整。

In addition, year-over-year comparisons vary as the RUO pharma business is lumpy throughout the year. This was an important quarter for drug discovery. We recognized the first IND development milestone from our cell therapy partnership with Genentech. This milestone represents a new revenue stream to help offset the decrease in the Genentech amortization this quarter.

此外，由於 RUO 製藥業務全年波動較大，因此同比比較有所不同。這是藥物發現的重要季度。我們與基因泰克的細胞治療合作夥伴關係實現了第一個 IND 開發里程碑。這一里程碑代表了新的收入來源，有助於抵消本季度基因泰克攤銷的減少。

Let's take a closer look at our cell therapy program with Genentech on Slide 8. Genentech secured the FDA IND acceptance for the first neoantigen-directed T-cell therapy product candidate. Importantly, this IND acceptance reaffirms the value of our TCR discovery platform and our ability to identify and characterize clinical-grade therapeutic T cell receptors, which is a cornerstone of our drug discovery capabilities. We are thrilled by this acceptance and look forward to supporting Genentech as it gears up for the first-in-human trial with this potentially life-saving therapy for patients with solid tumors.

讓我們仔細看看幻燈片 8 上我們與 Genentech 合作的細胞治療項目。Genentech 的第一個新抗原導向 T 細胞治療候選產品獲得了 FDA IND 受理。重要的是，此次 IND 接受重申了我們 TCR 發現平台的價值以及我們識別和表徵臨床級治療性 T 細胞受體的能力，這是我們藥物發現能力的基石。我們對這一接受感到興奮，並期待支持基因泰克，因為它正在為針對實體瘤患者的這種可能挽救生命的療法進行首次人體試驗做準備。

In addition, the personalized program is also maturing. We are on track to standardize our end-to-end workflows and are making good progress in building the required regulated infrastructure in our dedicated South San Francisco laboratory. Our focus with Genentech is to build the product development requirements this year that lay the foundation for clinical readiness.

此外，個性化方案也日趨成熟。我們正在標準化我們的端到端工作流程，並在我們專門的南舊金山實驗室建設所需的監管基礎設施方面取得了良好進展。我們與基因泰克今年的重點是製定產品開發要求，為臨床準備奠定基礎。

As you can see in Slide 9, in addition to our cancer cell therapy partnership with Genentech, we are executing to deliver on our key R&D proof points in autoimmunity. This includes focusing resources on high-value R&D programs to discover novel targets starting in multiple sclerosis. We aim to identify at least 1 novel disease specific target by year-end. We're excited by the progress we're making, and we look forward to providing an update as we advance these programs during the second half of this year. I'll now pass it over to Tycho.

正如您在幻燈片 9 中看到的，除了我們與基因泰克的癌症細胞治療合作夥伴關係外，我們還正在努力實現自身免疫方面的關鍵研發證明點。這包括將資源集中在高價值的研發項目上，以發現從多發性硬化症開始的新靶標。我們的目標是在年底前確定至少 1 個新的疾病特定目標。我們對所取得的進展感到興奮，並期待在今年下半年推進這些計劃時提供最新信息。現在我將把它交給第谷。

Thanks, Chad. Turning to our financials on Slide 10. Total revenue in the second quarter was $48.9 million, with 53% from MRD and 47% from immune medicine, representing a 12% increase from a year ago, which was primarily attributable to growth from the clonal Seat clinical business and the Genentech IND milestone. MRD revenue grew to $25.9 million, up 21% from a year ago, with growth from both clinical testing and pharma partnerships, partially offset by a lack of MRD regulatory milestones.

謝謝，查德。轉向幻燈片 10 上的財務數據。第二季度總收入為 4890 萬美元，其中 53% 來自 MRD，47% 來自免疫藥物，同比增長 12%，這主要歸功於克隆 Seat 的增長臨床業務和基因泰克IND里程碑。 MRD 收入增長至 2590 萬美元，比一年前增長 21%，這得益於臨床測試和製藥合作夥伴關係的增長，但部分被 MRD 監管里程碑的缺乏所抵消。

ClonoSEQ test volume, including international, increased 52% to 13,664 tests delivered from 8,998 tests in the same period last year. Immune medicine revenue was $23 million, up 3% from a year ago, driven by recognition of the IND milestone, which more than offset the decline in Genentech amortization and Pharma Services.

ClonoSEQ 測試量（包括國際測試量）從去年同期的 8,998 次測試增加到 13,664 次測試，增長了 52%。受 IND 里程碑認可的推動，免疫藥物收入為 2300 萬美元，同比增長 3%，這遠遠抵消了基因泰克攤銷和製藥服務的下降。

Now moving down the P&L on Slide 11. Total gross margin for the quarter was 63%, representing a 13 percentage point increase versus last quarter and a 6-point decline versus a year ago. The sequential increase was mainly attributed to the IND milestone as well as a 4% decrease in cost of revenue. Other OpEx, including R&D, sales and marketing and G&A declined 5% in total versus a year ago, mainly due to a 13% decline in R&D.

現在將幻燈片 11 上的損益表向下移動。該季度的總毛利率為 63%，比上季度增長 13 個百分點，比去年同期下降 6 個百分點。環比增長主要歸因於 IND 里程碑以及收入成本下降 4%。其他運營支出，包括研發、銷售和營銷以及一般管理費用總計比去年同期下降了 5%，主要是由於研發下降了 13%。

In total, OpEx including cost of revenues remained stable year-over-year and sequentially, while revenue grew 12% and 30%, respectively, during the same period. We look forward to continuing to optimize our processes to further enhance margins through a number of efforts, including streamlining the organization, disciplined R&D investments and completion of the Lab move with updated lab information management systems.

總體而言，包括收入成本在內的運營支出同比和環比保持穩定，而同期收入分別增長 12% 和 30%。我們期待著繼續優化我們的流程，通過一系列努力進一步提高利潤，包括精簡組織、嚴格的研發投資以及通過更新的實驗室信息管理系統完成實驗室搬遷。

In addition, we are evaluating switching from NextSeq to NovaSeq X, which we expect to contribute to significant savings going forward. Finally, interest expense from our royalty financing agreement with Orbimed was $3.6 million, which was offset by interest income.

此外，我們正在評估從 NextSeq 切換到 NovaSeq X，我們預計這將有助於未來大幅節省成本。最後，我們與 Orbimed 的特許權使用費融資協議產生的利息費用為 360 萬美元，被利息收入抵消。

Net loss for the quarter was $47.7 million compared to $52.1 million last year. We ended the quarter with approximately $417 million in cash, equivalents and marketable securities, which, as Chad noted in his comments, will bridge us to profitability without the need for additional capital.

本季度淨虧損為 4770 萬美元，而去年同期淨虧損為 5210 萬美元。本季度結束時，我們擁有約 4.17 億美元的現金、等價物和有價證券，正如乍得在評論中指出的那樣，這將使我們無需額外資本即可實現盈利。

Now turning to our outlook on Slide 11. We are reiterating full year guidance of $205 million to $215 million in revenues. At the midpoint, we continue to expect the contribution from our businesses to be approximately 55% from MRD and 45% from immune medicine. Within our MRD business, we expect over 50% growth in clonoSEQ test volumes as well as R&D regulatory milestones in the back half of the year.

現在轉向我們對幻燈片 11 的展望。我們重申全年收入指引為 2.05 億至 2.15 億美元。中點時，我們繼續預計我們業務的貢獻約為 55% 來自 MRD，45% 來自免疫醫學。在我們的 MRD 業務中，我們預計今年下半年 clonoSEQ 測試量以及研發監管里程碑將增長 50% 以上。

We expect second half revenues to be more heavily weighted towards the fourth quarter, mainly attributed to drug discovery deals that we expect to close by year-end. As we continue to drive operating efficiencies, we are also reiterating our full year OpEx targets, including cost of revenue to be below 2022 OpEx of [$385 million] (sic, see press release, "$385.5 million"). Cash preservation remains a priority, and we now expect our burn for the remainder of 2023 to average $35 million per quarter versus the $40 million previously estimated. Q2 financial results were solid, and we remain committed to driving additional operating leverage and achieving positive EBITDA in 2025 and cash breakeven in 2026. I'll now turn the call back over to Chad.

我們預計下半年收入對第四季度的比重將更大，這主要歸因於我們預計將在年底前完成的藥物發現交易。在我們繼續提高運營效率的同時，我們還重申了全年運營支出目標，包括收入成本低於 2022 年運營支出 [3.85 億美元]（原文如此，請參閱新聞稿“3.855 億美元”）。現金保存仍然是首要任務，我們現在預計 2023 年剩餘時間內每季度平均燒錢 3500 萬美元，而之前估計為 4000 萬美元。第二季度的財務業績穩健，我們仍然致力於提高運營槓桿率，並在 2025 年實現正 EBITDA，並在 2026 年實現現金收支平衡。現在我將把電話轉回給乍得。

Thanks, Tycho. As discussed during our call, our MRD and immune medicine businesses are performing well, and we are looking at ways to maximize the potential value of each business to best serve our patients and our shareholders. In our MRD business, we are executing to increase clonoSEQ penetration and solidify our market-leading position.

謝謝，第谷。正如我們在電話會議中所討論的，我們的 MRD 和免疫醫學業務表現良好，我們正在尋找方法來最大化每項業務的潛在價值，以便最好地為我們的患者和股東服務。在我們的 MRD 業務中，我們正在努力提高 clonoSEQ 的滲透率並鞏固我們的市場領先地位。

In our immune medicine business, we continue to advance our partner programs with Genentech and our internal R&D efforts in autoimmunity. With that, I'd like to turn the call back over to the operator and open it up for questions.

在我們的免疫醫學業務中，我們繼續推進與基因泰克的合作夥伴計劃以及我們在自身免疫方面的內部研發工作。這樣，我想將電話轉回給接線員並打開以供提問。

(Operator Instructions) Our first question comes from Rachel Vatnsdal of JPMorgan Chase.

（操作員指令）我們的第一個問題來自摩根大通的 Rachel Vatnsdal。

So first up, with Nitin's announced departure, can you just walk us through the management transition plan for MRD and if you expect to have any strategic changes in that business going forward? And as a follow-up, you flagged some of the temporary delays around clinical trials and reprioritization of portfolios at pharma. So could you walk us through how long do you think that those delays in reprioritization could really weigh on the MRD business?

首先，隨著 Nitin 宣布離職，您能否向我們介紹一下 MRD 的管理層過渡計劃，以及您是否預計該業務未來會有任何戰略變化？作為後續行動，您指出了製藥公司臨床試驗和投資組合優先順序調整方面的一些暫時延誤。那麼，您能否向我們介紹一下，您認為重新確定優先級的延遲會對 MRD 業務產生真正的影響多久？

Yes. Sure. Thanks for your questions, Rachel. First, with respect to Nitin, I want to thank Nitin, who is on the call. I will turn it over to him in a minute to make some comments, but I want to thank him for all the contributions to the business.

是的。當然。謝謝你的提問，雷切爾。首先，關於尼廷，我要感謝參加電話會議的尼廷。我稍後會將其交給他發表一些評論，但我要感謝他對業務的所有貢獻。

There's going to be a seamless transition that we are more than prepared for. We have an incredibly strong bench. Susan Bobulsky is going to lead the clinical business and report directly to me. She's been actually leading the clinical business with direct oversight of the sales team for the last several years, and is really a fantastic leader that's been with the company for 10 years.

我們已經做好了充分準備，將會實現無縫過渡。我們有一個非常強大的替補席。蘇珊·博布爾斯基將領導臨床業務並直接向我匯報。過去幾年裡，她實際上一直在直接監督銷售團隊的情況下領導臨床業務，在公司工作了 10 年，她確實是一位出色的領導者。

And the business is in really good shape and the strong foundation is there. We're firing on all cylinders. Closing volumes are growing at a very fast pace. We're committed to over 50% volume growth this year. And as mentioned during the call, all metrics are pointing in the right direction, and we're in very good shape and expect a very seamless transition. Nitin, do you want to make any comments?

而且業務狀況非常好，基礎也很牢固。我們正在全力以赴。成交量正在以非常快的速度增長。我們致力於今年銷量增長 50% 以上。正如電話會議期間提到的，所有指標都指向正確的方向，我們的狀況非常好，預計會實現非常無縫的過渡。尼丁，你有什麼意見嗎？

Yes. Thanks, Chad. This decision has been a difficult one, as Adaptive has been a truly rewarding place for me to work at. And the MRD business is on a solid foundation. Our latest quarterly results demonstrate that. We have a market-leading position in heme-cancer MRD with the best-performing products, strong clinical evidence, broad reimbursement and we are the product of choice in pharma. And Susan is a fantastic leader, has been a key player in building the business from the ground up.

是的。謝謝，查德。這個決定是一個艱難的決定，因為 Adaptive 對我來說是一個真正有價值的工作場所。 MRD業務有著堅實的基礎。我們最新的季度業績證明了這一點。我們在血紅素癌症 MRD 領域擁有市場領先地位，擁有性能最佳的產品、強有力的臨床證據、廣泛的報銷範圍，我們是製藥行業的首選產品。蘇珊是一位出色的領導者，一直是從頭開始建立業務的關鍵人物。

We have a dedicated and committed team that's deeply passionate about improving the lives of heme cancer patients. And I'm honored to play my part in such a solid impact to the business, and I'm very confident they'll do extremely well in the future and continue on the growth trajectory that we've demonstrated over the last few quarters. So it was not an easy choice. But again, I'm really delighted that Susan is stepping up and the business is on a very strong, strong footing. Chad, back to you.

我們擁有一支敬業奉獻的團隊，對改善血紅素癌症患者的生活充滿熱情。我很榮幸能夠在對業務產生如此重大影響的過程中發揮自己的作用，我非常有信心他們在未來會做得非常好，並繼續沿著我們在過去幾個季度展示的增長軌跡。所以這不是一個容易的選擇。但再次，我真的很高興蘇珊正在加緊努力，而且公司的業務基礎非常牢固。查德，回到你身邊。

And maybe just a comment there on clinical trials reprioritization.

也許只是對臨床試驗重新確定優先順序的評論。

Chad, do you want me to answer that? Or do you want to take that first? We've been closely monitoring the business, and we don't have a sort of a firm time line. We'll give you guys an update every quarter. A lot of our business in the MRD pharma space comes from multiple myeloma. We're in pretty much every trial in multiple myeloma. So not only there's some reprioritization of the portfolio going on in multiple myeloma, but a lot of these trials are competing for the same patient pool. And as a result, there's been some delays in enrollment. But we keep a close eye on it. And as in many we updates, we'll update you.

查德，你想讓我回答這個問題嗎？或者你想先拿那個？我們一直在密切關注業務，但沒有明確的時間表。我們每個季度都會向大家提供最新情況。我們在 MRD 製藥領域的許多業務都來自多發性骨髓瘤。我們幾乎正在進行每一項針對多發性骨髓瘤的試驗。因此，不僅對多發性骨髓瘤的治療組合進行了一些優先順序調整，而且許多此類試驗都在爭奪相同的患者庫。結果，註冊出現了一些延誤。但我們密切關注它。正如我們的許多更新一樣，我們也會向您更新。

Great. Well, best of luck. Maybe if I could just squeeze in one more on margins. Gross margin came in at 63% during the quarter, a nice improvement sequentially versus 1Q. So could you just walk us through the components of the increase there? And then really, how should we think about gross margins evolving for the rest of the year and even into 2024? And remind us, really, what are those margin drivers?

偉大的。好吧，祝你好運。也許如果我能在利潤上再擠一點的話。本季度毛利率為 63%，與第一季度相比有了不錯的改善。那麼您能否向我們介紹一下增長的組成部分？事實上，我們應該如何考慮今年剩餘時間甚至 2024 年的毛利率變化？並提醒我們，實際上，這些利潤驅動因素是什麼？

I think we lost the room that has Tycho, Chad and Sharon in it. So can we come back to that question because I think I will get in trouble for answering the financial question. So let's wait for Tycho to come back on and we'll return to that question. Are you back on?

我想我們失去了第谷、查德和莎倫所在的房間。那麼我們可以回到這個問題嗎，因為我認為回答財務問題會遇到麻煩。所以讓我們等第谷回來再回到這個問題。你回來了嗎？

Yes, we're back on.

是的，我們回來了。

Did you hear the question around gross margin?

您聽到有關毛利率的問題了嗎？

Yes, we did. Tycho is right here. Hold on.

是的我們做了。第谷就在這裡。堅持，稍等。

So as it relates to gross margins versus the prior quarter, milestones within our business, we have in both the MRD and immune medicine business, they come in at 100%. So we saw the lack of milestones have an impact on the first quarter. Conversely, in the second quarter, we obviously had the IND with Genentech that had a significant positive impact.

因此，由於它與上一季度的毛利率有關，是我們業務的里程碑，我們在 MRD 和免疫醫學業務中都有，它們都是 100%。因此，我們看到缺乏里程碑對第一季度產生了影響。相反，在第二季度，我們與基因泰克的 IND 顯然產生了重大的積極影響。

I did call out in the prepared comments, lower cost of revenues. So that drove about an 8-point improvement in sequencing margins. We're continuing to streamline the organization there and drive efficiencies in the lab. We are in the midst of a lab move. On the back of that, we're doing a LIMS implementation. We've talked about evaluating NovaSeq. So we have a number of drivers embedded for continued margin improvement around the sequencing business.

我確實在準備好的評論中呼籲降低收入成本。因此，測序裕度提高了約 8 個百分點。我們正在繼續簡化那裡的組織並提高實驗室的效率。我們正在進行實驗室搬遷。在此基礎上，我們正在實施 LIMS。我們已經討論過評估 NovaSeq。因此，我們嵌入了許多驅動因素，以持續提高測序業務的利潤率。

As it relates to the year-over-year dynamic, there was a step down in Genentech amortization and no MRD milestones. So that was a bit of a headwind this quarter. And then cost of revenue was higher due to overhead spending in the lab. Again, we're moving our labs into the headquarters right now. We're in the midst of that. So that will lead to lower cost of revenue on the back end, but that did weigh on it a little bit.

由於與同比動態相關，Genentech 攤銷有所下降，並且沒有 MRD 里程碑。因此，本季度這有點不利。由於實驗室的日常開支，收入成本更高。同樣，我們現在正在將實驗室搬到總部。我們正處於其中。因此，這將導致後端收入成本降低，但這確實對其造成了一些壓力。

Importantly, I would just once again flag the 8% sequential improvement in sequencing margins and the fact that we do have a number of additional steps for evaluating, including the potential shift to NovaSeq.

重要的是，我想再次指出測序裕度連續提高 8%，並且我們確實有許多額外的評估步驟，包括可能轉向 NovaSeq。

Our next question comes from Dan Brennan of TD Cowen.

我們的下一個問題來自 TD Cowen 的 Dan Brennan。

You talked about clonoSEQ ASPs. Could you just get a little more color there? Like what was the expectation? You mentioned a couple of the headwinds and actions you're taking to get the ASPs going in the right direction. Just walk us through a little bit of the impact this quarter and what we should expect going forward?

您談到了 clonoSEQ ASP。你能再多一點顏色嗎？就像期望是什麼？您提到了一些不利因素以及您為使 ASP 朝著正確方向發展而採取的行動。請向我們介紹一下本季度的一些影響以及我們未來應該期待什麼？

Yes. Sure, Dan. The quarter ASP was impacted by 3 different factors. One is growth in indications that remain out of policy. So looking at DLBCL and MCL as an example. The second was testing for Medicaid patients increased to 12% of our product mix. And then third, kind of prior authorization hurdles with certain payers.

是的。當然，丹。本季度平均售價受到 3 個不同因素的影響。一是政策之外的跡象增長。以 DLBCL 和 MCL 為例。第二個是針對醫療補助患者的測試增加到我們產品組合的 12%。第三，某些付款人的事先授權障礙。

And I should just say that we have an ASP acceleration plan in place that's focused on a couple of different items. The first is closing the remaining payer contracts and policy gaps. And the second is increasing our resources for claim management and prior authorizations to improve our collections.

我只想說，我們已經制定了 ASP 加速計劃，重點關注幾個不同的項目。首先是縮小剩餘的付款人合同和政策差距。第二是增加我們的索賠管理和事先授權資源，以改善我們的藏品。

So as we tackle some of the ASC leakage, we do expect to reverse the trend in the second half versus the first half of this year. And we are committed to an acceleration onward and are confident in reaching the $1,600 ASP kind of price point by 2027 with a kind of solid increase year-over-year to get there.

因此，當我們解決一些 ASC 洩漏問題時，我們確實預計下半年與上半年相比會扭轉這一趨勢。我們致力於加速前進，並有信心到 2027 年達到 1,600 美元的平均售價，並逐年穩步增長。

And then maybe just one back to Rachel's question on biopharma. So just kind of broadly, I know you don't give a lot of subcomponent details about guidance. But like where are we in the evolution of some of the biopharma kind of hopefully more temporary pressures on spending and maybe availability of patients? Like how do we think about the trajectory? Like Q3, does growth pick up on your -- both on the MRD side and then in the immunoSeq R&D side? Or do you think the type of growth persists for the rest of the year?

然後也許只是回到雷切爾關於生物製藥的問題。因此，從廣義上講，我知道您沒有提供很多有關指導的子組件詳細信息。但是，就像我們在某些生物製藥的發展過程中處於什麼階段一樣，希望對支出和患者的可用性產生更多暫時的壓力？比如我們如何看待軌跡？與問題 3 一樣，您的 MRD 方面和immunoSeq 研發方面的增長是否有所加快？或者您認為這種增長方式會在今年剩餘時間內持續下去嗎？

So we did talk about it being a back-end loaded year, more skewed towards the fourth quarter. Keep in mind, last year, we had about 55% of revenues in total in the fourth quarter. It will be a bit higher this year. There's a couple of other moving dynamics. I'll answer your pharma question in a minute, but we are expecting MRD to grow in the third quarter at a higher rate than we saw in the first half.

因此，我們確實談到了今年是後端負載較多的一年，更傾向於第四季度。請記住，去年第四季度我們的總收入約佔總收入的 55%。今年會高一點。還有一些其他的動態。我將立即回答您的製藥問題，但我們預計第三季度 MRD 的增長速度將高於上半年。

And then keep in mind, we had a big quarter of Genentech amortization in immune medicine in Q3 last year that was $20 million. So there's a little bit of a tough comp issue. And then we've got both growth in pharma services and new drug discovery deals that are in discussion that are expected to come in by the easy fourth quarter.

然後請記住，去年第三季度，我們在免疫醫學領域有很大一部分基因泰克攤銷，為 2000 萬美元。因此，存在一些棘手的補償問題。然後，我們正在討論製藥服務和新藥發現交易的增長，預計將在輕鬆的第四季度實現。

As it relates to pharma services, specifically, we've got a very diversified portfolio. We're involved in 120 active trials, 60 companies. It's a mix of smid-cap and large pharma in different stages of development. So I'm not sure if you heard my comment earlier because I know the line cut in and out, but we are committing to the 20% CAGR for that business over the next 5 years. So we're very confident in the long-term outlook.

具體來說，因為它與製藥服務相關，所以我們擁有非常多元化的產品組合。我們參與了 60 家公司的 120 項活躍試驗。它是處於不同發展階段的中型和大型製藥公司的混合體。所以我不確定你之前是否聽到了我的評論，因為我知道線路會進出，但我們承諾在未來 5 年內該業務的複合年增長率為 20%。所以我們對長期前景非常有信心。

It's also coming off a tough comp. That business had significant growth last year. So we are acknowledging that we do see some reprioritization of pipelines. But overall, given the diversified portfolio, we're comfortable that that pharma services business can continue to grow north of 20% over the next 5 years.

它也經歷了一場艱難的比賽。該業務去年取得了顯著增長。因此，我們承認我們確實看到了管道的一些優先級調整。但總體而言，鑑於多元化的投資組合，我們對製藥服務業務在未來 5 年內繼續增長 20% 以上感到滿意。

Our next question comes from David Westenberg of Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 David Westenberg。

So I just want to dive in a little bit more in terms of the ASPs here because you did have pretty good momentum going in that business. So it caught me a little bit off guard here. Can you talk about how those uncovered indications tend to grow faster. I mean, was there a lot of marketing? Was there just kind of an under penetration and maybe you're over -- more penetrated in kind of the higher growth indications?

因此，我只想更深入地了解一下 ASP，因為您在該業務方面確實有相當好的勢頭。所以這讓我有點措手不及。您能談談那些未發現的跡像如何往往增長得更快嗎？我的意思是，有很多營銷嗎？是否只是滲透率不足，也許你已經結束了——在更高的增長跡像中滲透率更高？

Well, first, let's take -- hi David -- let's take DLBCL. DLBCL grew 28% quarter-over-quarter, albeit from a somewhat lower base. So it is increases in new indication, but it's a variety of different factors. One is an industry-related factor that Medicare advantage from private payers has been a challenge for the industry in collections. And we've got a very targeted plan to work on collecting at the Medicare rate for Medicare Advantage plans is another area.

好吧，首先，讓我們來看看——嗨大衛——讓我們來看看 DLBCL。 DLBCL 環比增長 28%，儘管基數稍低。所以這是新適應症的增加，但有多種不同的因素。一是與行業相關的因素，即醫療保險從私人付款人那裡獲得的優勢一直是該行業在收款方面面臨的挑戰。我們還有一個非常有針對性的計劃，致力於以 Medicare 費率為 Medicare Advantage 計劃收取費用，這是另一個領域。

But it's kind of -- as you grow indications and new indications that aren't covered yet, you tend to -- that tends to be going to -- while a drag on ASPs, it also bodes well for the future as we close those policy and payer gaps. So net-net, we've got very targeted ASP acceleration plan in place. We expect to reverse that. It's actually already starting to reverse in the third quarter, expect to reverse it not only second half of the year, but going forward, to be able to achieve kind of that top line 1,600 by 2027.

但這是一種——隨著適應症和尚未涵蓋的新適應症的增長，你往往會——這往往會——雖然會拖累平均售價，但隨著我們關閉這些適應症，這對未來來說也是個好兆頭政策和付款人之間的差距。因此，我們已經制定了非常有針對性的 ASP 加速計劃。我們希望扭轉這一局面。事實上，第三季度已經開始出現逆轉，預計不僅會在下半年逆轉，而且在未來，到 2027 年能夠達到 1,600 人的營收。

And then is there any headwind from maybe getting tests ran outside of the first 4 covered indication in Medicare? Are you seeing Medicare patients order that? Can that be a potential headwind in the future? And then just to clarify, I believe most of your private payer coverage, it's just based on a test by taste basis. It's not the same way as that Medicare. And so I'm going to squeeze one more in. You do seem to be implying like on a sequential -- we should be returning to sequential improvement in ASPs as we see maybe quarter-on-quarter sequential improvement or year-on-year sequential improvement. I mean, that is tracking when we see, I don't know, maybe next year, Q1-ish.Sorry, I'm kind of rambling here.

那麼，在 Medicare 的前 4 個承保適應症之外進行測試是否會帶來不利影響？您是否看到醫療保險患者訂購此產品？這會成為未來潛在的阻力嗎？然後澄清一下，我相信大多數私人付款人的承保範圍只是基於品味測試。這和Medicare不一樣。因此，我要再補充一點。您似乎確實在暗示，我們應該回到 ASP 的連續改善，因為我們可能會看到季度環比或同比的連續改善順序改進。我的意思是，當我們看到時，我不知道，也許明年第一季度左右。抱歉，我在這裡有點漫無目的。

No, it's like Rodney Dangerfield in back to school. But I think I got -- I think I'm tracking you, David. So a couple of things. One is our test-by-test basis for private payers, the answer is yes, that's confirmed. It's not on an episode of care basis like it is on Medicare. The third question was with regards to ASP acceleration. We do have a targeted plan for ASP acceleration, and we do expect ASPs to accelerate in the second half of this year.

不，這就像《重返校園》中的羅德尼·丹澤菲爾德。但我想我——我想我正在追踪你，大衛。有幾件事。一是我們對私人付款人的測試依據，答案是肯定的，這是確認的。它不像醫療保險那樣以護理為基礎。第三個問題是關於ASP加速的。我們確實有一個針對 ASP 加速的目標計劃，並且我們確實預計 ASP 將在今年下半年加速。

And then the third, if you look at kind of our different indications, I will just say that multi-myeloma continues to be the biggest growth driver. It is under coverage policy but we are expanding indications for CLL and diffuse large B-cell lymphoma in other indications with private payers as well. So if you combine all those factors, that's what's going to lead to ASP acceleration along with, again, I can't reiterate enough that we're putting additional resources into kind of workflow and collections and getting prior authorizations where necessary.

第三，如果你看看我們不同的適應症，我只會說多發性骨髓瘤仍然是最大的增長動力。它屬於承保政策範圍內，但我們也在與私人付款人一起擴大 CLL 和瀰漫性大 B 細胞淋巴瘤其他適應症的適應症。因此，如果將所有這些因素結合起來，這將導致 ASP 加速，而且我再次強調，我們正在將額外的資源投入到工作流程和集合中，並在必要時獲得事先授權。

So I'm squeezing in a third, so you answered it pretty quick. Just on the biotech funding, are you seeing that in immune medicine or MRD or both? And hopefully, you can just answer that quickly.

所以我擠了三分之一，所以你很快就回答了。就生物技術資金而言，您是否在免疫醫學或 MRD 或兩者中看到了這一點？希望您能快速回答這個問題。

Sorry, everybody, for that third question.

對不起，大家，第三個問題。

We're seeing that a little bit in both as budget reprioritization. However, both have strong pipelines in place. and market-leading position. So we -- but we do see some impact for different reasons. In the case of budget prioritization in the MRD pharma business. Some of it also has to do with kind of multiple myeloma competition for patients in clinical trials as well.

我們在預算優先順序調整中都看到了這一點。然而，兩者都擁有強大的管道。和市場領先地位。所以我們——但我們確實看到了出於不同原因的一些影響。就 MRD 製藥業務的預算優先順序而言。其中一些也與臨床試驗中患者的多發性骨髓瘤競爭有關。

Our next question comes from Mark Massaro of BTIG.

我們的下一個問題來自 BTIG 的馬克·馬薩羅 (Mark Massaro)。

It's tough to follow Rodney Dangerfield on a call. But -- and I wanted to say Nitin, it was good working with you and best of luck going forward, and Susan and I look forward to working with you some more. We got some investor questions. A little more on the ASP side. So Tycho, I heard you maintain the clonoSEQ volume guidance for 50% plus, which is great to see. I think you guys had previously talked about wanting to grow clonoSEQ ASPs up in the mid-single-digit range. Although today, you guys called out some of the 3 pressures that you called out.

在電話中跟踪羅德尼·丹澤菲爾德（Rodney Dangerfield）是很困難的。但是——我想說尼汀，與你合作很愉快，祝你未來好運，蘇珊和我期待著與你更多的合作。我們收到了一些投資者的問題。關於 ASP 方面的更多內容。所以，Tycho，我聽說您將 clonoSEQ 交易量指導維持在 50% 以上，這真是太好了。我想你們之前曾討論過希望將 clonoSEQ ASP 提高到中個位數範圍。雖然今天你們喊出了你們喊出的3個壓力中的一些。

So I'm just curious if that mid-single-digit growth in ASPs is still on target? Or do you think that might drift into 2024 as you kind of make progress on some of those initiatives you called out?

所以我只是好奇平均售價中個位數的增長是否仍然達到目標？或者您是否認為隨著您所呼籲的一些舉措取得進展，這可能會推遲到 2024 年？

Yes. I mean we're definitely expecting an improvement in the back half of the year versus the first half. We had noise in both the first and second quarter here, in particular, around Medicare Advantage, Medicaid overall, by the way, is 12% of our test mix. So the -- and then Chad talked about growth and indications out of policy.

是的。我的意思是，我們肯定預計下半年的情況會比上半年有所改善。我們在第一季度和第二季度都遇到了噪音，特別是在 Medicare Advantage 方面，順便說一下，Medicaid 總體占我們測試組合的 12%。然後乍得談到了增長和政策的跡象。

But yes, I'd say stay tuned. I mean, I don't know that we necessarily want to update. We're going to update on the third quarter in terms of how we're thinking about ASPs for the full year, but we do expect the back half certainly to be better than the first half. Again, we've taken a lot of steps over the last few months to tackle the ASP leakage. It's an industry-wide problem, by the way. I mean (inaudible) our competitors are dealing with a lot of this noise too. And we are still expecting to get to $1,600 over time. So whether it takes a quarter or 2 to kind of work through the rest of this noise, TBD, but we're very comfortable in the long-term outlook for ASPs overall.

但是，是的，我想說請繼續關注。我的意思是，我不知道我們是否一定要更新。我們將在第三季度更新我們對全年平均售價的看法，但我們確實預計下半年肯定會好於上半年。同樣，我們在過去幾個月中採取了許多措施來解決 ASP 洩漏問題。順便說一句，這是一個全行業的問題。我的意思是（聽不清）我們的競爭對手也正在處理很多這種噪音。隨著時間的推移，我們仍預計將達到 1,600 美元。因此，是否需要四分之一或兩個季度才能解決其餘的噪音，待定，但我們對 ASP 的整體長期前景感到非常滿意。

Yes, and add CareDx to that list as well of labs dealing with these pressures. Okay. So I guess can you guys call out what the milestone payment was in the quarter? I think it's somewhere in the $4 million to $7 million range. Is that the right ballpark?

是的，並將 CareDx 添加到處理這些壓力的實驗室列表中。好的。所以我想你們能說出本季度的里程碑付款是多少嗎？我認為它的價格在 400 萬至 700 萬美元之間。這是正確的球場嗎？

So Dave, there was the Genentech IND acceptance, right? That was 7.8%. It's a $10 million milestone, but we amortize the rest of it. And yes, there was nothing for MRD.

Dave，基因泰克 IND 已被接受，對吧？那是7.8%。這是 1000 萬美元的里程碑，但我們會攤銷其餘部分。是的，MRD 沒有任何東西。

Perfect. And then just last one, just to kind of clarify. Obviously, I don't think there's any change to reimbursement rate for clonoSEQ, nothing like that. I think this is largely just a function of higher Medicaid mix, some prior auth, mix of DLBCL. I guess one of the things I think investors would love clarity on is how quickly do you think you guys can make progress on the prior auth side? And then do you think Medicaid is transitory? Or do you think that will remain around 12% of mix? And then like where are you guys again on DLBCL commercial payer? I know it's super early, but are you guys making any progress there? Or do you think it's going to be more of a further out?

完美的。最後一個，只是為了澄清一下。顯然，我不認為 clonoSEQ 的報銷率有任何變化，沒有什麼變化。我認為這很大程度上只是更高的醫療補助組合、一些先前的授權、DLBCL 組合的函數。我想投資者希望弄清楚的一件事是，你們認為你們能在事先授權方面取得進展多快？那麼您認為醫療補助是暫時的嗎？或者您認為這一比例會保持在 12% 左右嗎？然後你們又在 DLBCL 商業付款人的哪裡？我知道現在還太早，但是你們有進展嗎？或者你認為它會更遠？

Yes. So just to address the (inaudible) that in terms of Medicaid, we're looking at converting some of the high ordering accounts that have made a high volume of Medicaid patients to roster billing accounts to close some of that gap. With respect to prior authorizations, we've already started implementing and putting that kind of workflow in place to get prior authorization. So this isn't a several quarters out. This is happening now.

是的。因此，為了解決醫療補助方面的（聽不清）問題，我們正在考慮將一些產生大量醫療補助患者的高級帳戶轉換為名冊計費帳戶，以縮小部分差距。關於事先授權，我們已經開始實施並落實這種工作流程以獲得事先授權。所以這不是幾個季度的事情。現在這種情況正在發生。

And then third, in terms of Medicare Advantage and private payers covering at the Medicare rates, we've already started to make progress on that front as well. Your last question with respect to coverage in DLBCL and frankly, other indications. We've done a good job on CLL. We're now about 200 million lives under contract. DLBCL, we have additional data readouts coming in ASH, which we think should be a catalyst for private payer contracts into 2024. The current rate is we have about 75 million covered lives under it and we look to increase that significantly in 2024.

第三，就醫療保險優勢和私人付款人按醫療保險費率承保而言，我們也已經開始在這方面取得進展。您的最後一個問題是關於 DLBCL 的覆蓋範圍，坦率地說，還有其他適應症。我們在 CLL 方面做得很好。現在我們有大約 2 億人的生命處於合同之下。 DLBCL，我們在ASH 中獲得了額外的數據讀數，我們認為這應該會成為2024 年私人付款人合同的催化劑。目前的比率是我們約有7500 萬人受保，我們希望在2024 年大幅增加這一數字。

Our next question comes from Salveen Richter of Goldman Sachs.

我們的下一個問題來自高盛的 Salveen Richter。

This is Elizabeth on for Salveen. I wanted to ask about the impact of the Epic integration on MRD going forward through the end of this year and into next and what you would expect in terms of the cadence of growth impact from that as it seems like it could be a significant driver. And then just on the Genentech collaboration, when we could expect an update on the personalized products.

這是薩爾文的伊麗莎白。我想詢問 Epic 集成對今年年底和明年的 MRD 的影響，以及您對由此產生的增長影響的節奏的期望，因為它似乎可能是一個重要的驅動因素。然後就是與基因泰克的合作，我們可以期待個性化產品的更新。

Yes, sure. Thanks, Elizabeth. First, yes, we're thrilled that we're starting the first Epic integration this month with a couple of different customers. The first successful Epic launches, I think, demonstrate what is incredibly hard work to integrate into the Epic site. And so we're ready to go. We have received substantial interest from additional sites that are eager to gain access to clonoSEQ testing and integrate with their EMR system.

是的，當然。謝謝，伊麗莎白。首先，是的，我們很高興本月將與幾個不同的客戶開始首次 Epic 集成。我認為，Epic 的首次成功發布展示了融入 Epic 網站的艱鉅工作。我們準備出發了。我們收到了其他站點的濃厚興趣，這些站點渴望獲得 clonoSEQ 測試並與其 EMR 系統集成。

Rollout is really gated by the availability of the IT resources at each different center. So it is kind of really a hand-to-hand combat with each site. But the reality is there's a ton of interest and we'll be kind of rolling them on month by month, quarter by quarter until we have what we deem as full penetration as much as possible within Epic.

部署實際上取決於每個不同中心的 IT 資源的可用性。所以這實際上是與每個站點的肉搏戰。但現實情況是，人們對此很感興趣，我們將逐月、逐季地滾動它們，直到我們在 Epic 中實現我們認為的盡可能全面的滲透。

Just a couple of numbers here for you. I think as of June, there are 161 sites in the U.S. that had adopted Epic or a network, which is their precision medicine add-on that's required for clonoSEQ integration. And it's also required for all the other diagnostic tests that are partnered with Epic such as FMI Exact, et cetera.

這裡只是為您提供幾個數字。我認為截至 6 月，美國有 161 個站點採用了 Epic 或網絡，這是 clonoSEQ 集成所需的精準醫學附加組件。與 Epic 合作的所有其他診斷測試（例如 FMI Exact 等）也需要它。

It will take us a few years to get through that number of integrations. In the meantime, the list of sites that kind of adopt or will also continue to grow. So we expect that -- we expect that this will grow over time. And we also have talked about really the contributions in terms of volume being really coming in 2024, although we will see kind of some impact in the back half of this year, which we talked about to achieve our over 50% volume growth.

我們需要幾年的時間才能完成這麼多的集成。與此同時，採用這種方式的網站列表也將繼續增長。所以我們預計——我們預計這一數字會隨著時間的推移而增長。我們還談到了 2024 年銷量方面的貢獻，儘管我們會在今年下半年看到一些影響，我們談到要實現超過 50% 的銷量增長。

Got it. That's helpful. And then just on the time lines for an update on the personalized product.

知道了。這很有幫助。然後就是個性化產品更新的時間表。

Sharon, can you take that one?

莎倫，你能拿走那個嗎？

Absolutely Elizabeth, thanks for the question. So of course, on the heels of the first IND FDA clearance, this, of course, validates our ability to identify clinical grade therapeutic T-cell receptors that is for the first product. And obviously, the capabilities built to that end is what we're also leveraging for the fully personalized.

絕對是伊麗莎白，謝謝你的提問。因此，在首次 IND FDA 批准之後，這當然驗證了我們識別第一個產品的臨床級治療性 T 細胞受體的能力。顯然，我們也正在利用為此目的構建的功能來實現完全個性化。

In terms of time lines, we're not in a position to disclose specific time lines, but certainly, in terms of an update, we're continuing to develop the prototype hand-in-hand with Genentech across really multiple parameters. Number one is the number of patients to whom we can identify specific TCRs to each patient's unique tumor mutation and then really having an understanding to ultimately standardize the ability to understand the total number of T-cell receptors we can identify from each patient. And that allows us to establish really a more reproducible, reliable expectations for the end-to-end process that we're putting in place.

就時間表而言，我們無法透露具體的時間表，但當然，就更新而言，我們將繼續與基因泰克攜手開發跨多個參數的原型。第一個是我們可以識別每位患者獨特腫瘤突變的特定 TCR 的患者數量，然後真正了解並最終標準化了解我們可以從每位患者中識別的 T 細胞受體總數的能力。這使我們能夠對我們正在實施的端到端流程真正建立一個更具可重複性、更可靠的期望。

So more to come across the board on that. I will say that in terms of updates, Genentech earlier this year started just sharing some of the data, including the proof-of-concept study design for lung cancer patients that we also presented earlier this year in a conference in New York. And that was a great example of one patient where end-to-end, the process has worked. And so we'll obviously look forward to sharing more information as more data reads out with our partner, Genentech.

因此，在這方面還有更多的事情要做。我要說的是，就更新而言，基因泰克今年早些時候開始共享一些數據，包括我們今年早些時候在紐約的一次會議上提出的針對肺癌患者的概念驗證研究設計。這是一位患者的一個很好的例子，該過程從頭到尾都發揮了作用。因此，隨著更多數據的讀出，我們顯然期待與我們的合作夥伴基因泰克分享更多信息。

Our next question comes from Tejas Savant of MS.

我們的下一個問題來自 MS 的 Tejas Savant。

This is Yuko on the call for Tejas. Following the recognition of IND acceptance milestone from Genentech this quarter, could you speak to the next events that could trigger a milestone? And would you recognize a similar amount of milestone, approximately $7.8 million, upon IND acceptance of additional candidates that advance into the clinic? Or should we expect the milestone for the IND acceptance of the first candidates to be bigger than the additional candidates that follows?

我是 Yuko，正在為光輝號通話。繼本季度基因泰克 (Genentech) 認可 IND 受理里程碑之後，您能談談接下來可能觸發里程碑的事件嗎？在 IND 接受更多候選人進入臨床後，您是否會認識到類似金額的里程碑，即大約 780 萬美元？或者我們是否應該期望 IND 接受第一批候選藥物的里程碑比隨後的其他候選藥物更大？

Thanks for the question. We haven't disclosed the quantum of IND milestones, but of course, they stack. And the more progress across development of a given candidate as is typical in these types of licensing deals, the higher the economics. So we're excited, certainly by this first IND clearance. And as was mentioned, we do have other TCRs that are being advanced as well as ultimately our fully personalized product program.

謝謝你的提問。我們還沒有透露 IND 里程碑的數量，但當然，它們是疊加的。特定候選藥物的開發進展越大（在此類許可交易中很常見），經濟效益就越高。因此，我們對第一個 IND 許可感到興奮。正如所提到的，我們確實有其他正在推進的 TCR，以及最終我們完全個性化的產品計劃。

And then regarding the evolving landscape and move towards the use of MRD status as a regulatory endpoint in clinical trials. Could you provide an update on where that stands today and how you see the more recent conversion of BLINCYTO to full approval influence that view?

然後考慮不斷變化的形勢，並轉向使用 MRD 狀態作為臨床試驗中的監管終點。您能否提供有關目前情況的最新信息以及您如何看待 BLINCYTO 最近轉變為完全批准對這種觀點的影響？

Yes, Yuko. So we continue to put pressure along with our pharma partners on the agency for the use of MRD as an endpoint, particularly as moving from surrogate to secondary to primary endpoint. We do believe that we are making progress in the data that continue to be generated points in the direction that this should be converted to an endpoint in clinical trials soon.

是的，優子。因此，我們繼續與我們的製藥合作夥伴一起向該機構施加壓力，要求其使用 MRD 作為終點，特別是從替代終點到次要終點再到主要終點。我們確實相信，我們正在不斷產生的數據方面取得進展，這應該很快就會轉化為臨床試驗的終點。

It's really hard to be prescriptive about giving a time frame as to when the FDA is going to act on it, but metrics are pointing in the right direction. So the second question, again?

確實很難規定 FDA 何時採取行動的時間框架，但指標指向正確的方向。那麼第二個問題又來了？

Just wondering if the recent approval -- full approval of BLINCYTO that had an accelerated approval a few years ago, if that influences the view on the primary endpoints or have you seen any more traction following that?

只是想知道最近批准的 BLINCYTO 的全面批准是否在幾年前加速批准，這是否影響了對主要終點的看法，或者您是否看到了隨後的更多吸引力？

Yes. I mean, so Glen and ALL, I think it does vary by indication. We're primarily now focused on multi myeloma. I think that's, to us, the biggest catalyst. If you look at where our milestones are. I think that clearly, it's helpful to have kind of full approvals that use MRD in their trials across indications. There is a CLL study with Genentech as well that includes MRD. So yes, a lot of different pressures from multiple directions in multiple indications are pointing towards the incorporation of MRD as an endpoint by the agency.

是的。我的意思是，所以格倫和所有，我認為它確實因適應症而異。我們現在主要關注多發性骨髓瘤。我認為這對我們來說是最大的催化劑。如果你看看我們的里程碑在哪裡。我認為，顯然，在跨適應症的試驗中使用 MRD 獲得完全批准是有幫助的。 Genentech 還開展了一項 CLL 研究，其中包括 MRD。因此，是的，來自多個方向、多種適應症的許多不同壓力都指向該機構將 MRD 納入終點。

And then I'll just add, Yuko, you've heard us talk in the past, we've got line of sight to about $400 million in eligible milestones -- sorry, lines of sight of about $170 million of that. But if FDA does move forward and endorse MRD as a primary endpoint, that's kind of upside relative to what we've previously talked about in terms of the path to profitability. So that's not baked in the guidance at this point.

然後我要補充一點，Yuko，你過去聽過我們談論過，我們已經看到了大約 4 億美元的合格里程碑——抱歉，大約有 1.7 億美元的視線。但如果 FDA 確實向前邁進並認可 MRD 作為主要終點，那麼相對於我們之前討論的盈利路徑而言，這就是一種上行趨勢。所以目前指南中還沒有提到這一點。

Our next question comes from Dan Leonard of Credit Suisse.

我們的下一個問題來自瑞士信貸銀行的丹·倫納德。

You talked about Epic. I'm wondering if you could update us on your efforts to integrate clonoSEQ with community EMRs.

你談到了史詩。我想知道您是否可以向我們介紹您將 clonoSEQ 與社區 EMR 集成的最新情況。

Yes. So we -- obviously, Epic isn't the EMR of choice in the community. We are evaluating the EMR systems to figure out just colloquially where we're going to get the biggest bang for our buck as we look to essentially make the test easier to order and integrate into system. So it's certainly on the radar and under evaluation.

是的。因此，顯然，Epic 不是社區選擇的 EMR。我們正在評估 EMR 系統，以便通俗地找出我們將在哪裡獲得最大的收益，因為我們希望從本質上使測試更容易訂購併集成到系統中。所以它肯定受到關注並正在評估中。

And then my follow-up. Can you speak to your expectation for more drug discovery deals in the fourth quarter? And how confident you are, given the macro factors and reprioritization that you flagged?

然後是我的後續行動。您能否談談您對第四季度更多藥物發現交易的預期？考慮到您所標記的宏觀因素和重新確定的優先順序，您的信心有多大？

Yes. Sure. I'll start with that and then maybe pass it off to the team for additional color. First, it should be noted that the deals that we have for drug discovery in the fourth quarter are based on the existing data that we've already developed and the platforms that we've developed in TCR discovery and antibody discovery. And the discussions are well underway. They're in progress. They've been advancing. Otherwise, they wouldn't be incorporated into our annual numbers here.

是的。當然。我會以此開始，然後可能會將其傳遞給團隊以獲取更多顏色。首先，應該指出的是，我們第四季度的藥物發現交易是基於我們已經開發的現有數據以及我們在 TCR 發現和抗體發現方面開發的平台。討論正在進行中。他們正在進行中。他們一直在進步。否則，它們就不會被納入我們這裡的年度數據中。

And then secondly, we have a series of essentially target discovery initiatives underway that are really exciting, and I think will lead to future development deals as well. We can either choose to partner on those programs or develop those targets in-house, combining with our platform capabilities. Tyco, did you want to add anything on that? Okay, great.

其次，我們正在進行一系列本質上是目標發現的舉措，這些舉措非常令人興奮，我認為這也將導致未來的開發交易。我們可以選擇在這些項目上進行合作，也可以結合我們的平台能力在內部開發這些目標。泰科，你想補充什麼嗎？好的，太好了。

Our next question comes from Derik De Bruin of Bank of America.

我們的下一個問題來自美國銀行的 Derik De Bruin。

Just impressive that you're going to do 50% volume growth this year in clonoSEQ. Right now, looking at the visible alpha consensus, the Street is looking for about 40% growth in 2024 -- year-over-year growth. Is that a reasonable number to think just given some of the ERP integrations and things that are going on? Is that -- I mean are you comfortable with growing at that level?

令人印象深刻的是，今年 clonoSEQ 的銷量將增長 50%。目前，從可見的阿爾法共識來看，華爾街預計 2024 年將實現 40% 左右的增長——同比增長。考慮到一些 ERP 集成和正在發生的事情，這個數字是否合理？那是——我的意思是你對在這個水平上的成長感到滿意嗎？

Derik, we haven't put out guidance yet for 2024. However, I can say we are committed to significant double-digit growth. We think there's a strong trajectory in clonoSEQ volumes that will continue well into the future. So I would -- if I had to go off, it's not unreasonable, but we'll get back to you with more specifics as we come out with our guidance.

Derik，我們尚未發布 2024 年的指導。不過，我可以說我們致力於實現兩位數的大幅增長。我們認為 clonoSEQ 銷量的強勁發展軌跡將在未來持續下去。所以我會——如果我必須離開，這並不是不合理的，但我們會在提供指導後向您提供更多具體信息。

Got it. And can you talk a little bit about just upcoming milestones or catalysts for your autoimmune program? How should we sort of think about that since autoimmunity being a lot more interesting AI than some of the other stuff?

知道了。您能談談即將到來的里程碑或自身免疫計劃的催化劑嗎？既然自身免疫是比其他一些東西更有趣的人工智能，我們應該如何思考這一點？

Absolutely. It's Sharon. So in our focus in R&D and autoimmunity, as we've indicated, our goal this year is to discover at least 1 novel target in 1 indication, including our focus specifically is in multiple sclerosis and IBD. And so we're making great progress and are quite excited. Some of the ramifications here is that we're looking at targets that are implicated in a large patient population.

絕對地。是莎倫。因此，正如我們所指出的，我們今年的目標是在 1 個適應症中發現至少 1 個新靶標，其中我們特別關注多發性硬化症和 IBD。因此，我們正在取得巨大進展並且非常興奮。這裡的一些後果是，我們正在尋找與大量患者群體有關的目標。

And then the data we're generating to accelerate target identification is absolutely leveraging some of our existing machine learning and AI capabilities, including, of course, with our partner, Microsoft. So we're extremely bullish around novel target discovery and really the discovery engine that we're building the foundations of around MS and other autoimmune indications to come.

然後，我們為加速目標識別而生成的數據絕對會利用我們現有的一些機器學習和人工智能功能，當然也包括我們的合作夥伴微軟。因此，我們非常看好新目標的發現，以及我們正在為多發性硬化症和其他自身免疫適應症奠定基礎的發現引擎。

I'm showing no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.

我目前沒有提出任何進一步的問題。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。