Adaptive Biotechnologies Corp (ADPT) 2022 Q4 法說會逐字稿

Good day and thank you for standing by, and welcome to the Fourth Quarter and Full Year 2022 Conference Call. (Operator Instructions)

美好的一天，感謝您的支持，歡迎來到 2022 年第四季度和全年電話會議。 （操作員說明）

I would now like to hand the conference over to your speaker today, Karina Calzadilla. You may go ahead.

我現在想把會議交給今天的發言人 Karina Calzadilla。你可以繼續。

Thank you, Justin, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies fourth quarter and full year 2022 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the fourth quarter and full year of '22. The press release is available at www.Adaptivebiotech.com. We are conducting a live webcast of this call and we'll be referencing to a slide presentation that has been posted to the investor section in our corporate website.

謝謝賈斯汀，大家下午好。歡迎您參加 Adaptive Biotechnologies 第四季度和 2022 年全年收益電話會議。今天早些時候，我們發布了一份新聞稿，報告 Adaptive 22 年第四季度和全年的財務業績。新聞稿可在 www.Adaptivebiotech.com 獲取。我們正在對此次電話會議進行網絡直播，我們將參考已發佈到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，管理層將根據聯邦證券法對未來事件和公司未來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對當今業務的當前看法。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的以及本演示文稿中列出的多種因素。

In addition, non-GAAP financial measures will be discussed during this 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. In addition, Harlan Robins, Adaptive's Chief Scientific Officer and Co-founder; Nitin Sood, Head of the MRD business; and Sharon Benzeno, Head of the Immune Medicine business will be available for Q&A.

此外，本次電話會議將討論非 GAAP 財務措施，並且可以在我們的收益發布中找到從非 GAAP 指標到 GAAP 指標的對賬。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)；和我們的首席財務官 Tycho Peterson。此外，Adaptive 的首席科學官兼聯合創始人 Harlan Robins； MRD 業務負責人 Nitin Sood；免疫醫學業務負責人 Sharon Benzeno 將出席問答環節。

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

有了這個，我會把電話轉給查德羅賓斯。乍得？

Thanks, Karina. Good afternoon, everybody, and thank you for joining us on our 2022 fourth quarter and full year earnings call. As always, I want to thank all of our Adaptive employees for their dedication and strong execution throughout the year.

謝謝，卡琳娜。大家下午好，感謝您加入我們的 2022 年第四季度和全年財報電話會議。一如既往，我要感謝我們所有的 Adaptive 員工全年的奉獻精神和強大的執行力。

As you can see on Slide 3, 2022 was a year of key decisions and achievements for Adaptive. We started with the reorganization of the company around 2 business areas, MRD and Immune Medicine. We established clear strategic goals for each of these two business areas and executed against these goals by hitting key deliverables throughout the year. Following the restructuring, we shared our long-range financial plan to achieve sustainable revenue growth while reaching adjusted EBITDA profitability in 2025. We also strengthened our cash position with a nondilutive royalty financing agreement. Importantly, given our 2022 ending cash position of $498 million, we do not anticipate the need to raise additional capital to achieve our profitability targets. Both of our business areas achieved significant progress and finished the year strong.

正如您在幻燈片 3 中看到的那樣，2022 年是 Adaptive 做出關鍵決策和取得成就的一年。我們首先圍繞 2 個業務領域（MRD 和免疫醫學）對公司進行了重組。我們為這兩個業務領域中的每一個領域都制定了明確的戰略目標，並通過全年實現關鍵可交付成果來實現這些目標。重組後，我們分享了我們的長期財務計劃，以實現可持續的收入增長，同時在 2025 年實現調整後的 EBITDA 盈利能力。我們還通過非稀釋性特許權使用費融資協議加強了我們的現金狀況。重要的是，鑑於我們 2022 年末的現金頭寸為 4.98 億美元，我們預計不需要籌集額外資金來實現我們的盈利目標。我們的兩個業務領域都取得了重大進展，並以強勁的勢頭結束了這一年。

In MRD, clonoSEQ clinical volumes grew 51% versus fiscal year 2021, supported by our fully trained sales team, which we nearly doubled during the year. In addition, we launched clonoSEQ and DLBCL and signed an agreement with EPIC for EMR integration, both are key milestones that are fundamental to the growth of our MRD business. In Immune Medicine, we made the strategic decision to focus our commercial and development efforts around pharma services and drug discovery. Pharma services had substantial growth of 67% versus 2021. In drug discovery, our partnership with Genentech had significant progress in both of our cell therapy programs. We are optimistic about the potential of Genentech advancing the first candidate into the clinic.

在 MRD 方面，在我們訓練有素的銷售團隊的支持下，clonoSEQ 臨床量與 2021 財年相比增長了 51%，這一年我們幾乎翻了一番。此外，我們推出了 clonoSEQ 和 DLBCL 並與 EPIC 簽署了 EMR 集成協議，這兩個都是對我們 MRD 業務增長至關重要的關鍵里程碑。在 Immune Medicine，我們做出了將我們的商業和開發工作集中在製藥服務和藥物發現方面的戰略決策。與 2021 年相比，製藥服務實現了 67% 的大幅增長。在藥物發現方面，我們與基因泰克的合作夥伴關係在我們的兩個細胞治療項目中都取得了重大進展。我們對 Genentech 將第一位候選人推進臨床的潛力持樂觀態度。

In addition to Genentech, we are focused on leveraging our capabilities to develop our internal programs in autoimmune disorders. We finished the year with a strong fourth quarter of $55.2 million in total revenue, representing a significant growth of 46% versus prior year. And our fiscal year 2022 revenue of $185.3 million reflects a 20% growth versus 2021.

除了 Genentech 之外，我們還專注於利用我們的能力來開發我們在自身免疫性疾病方面的內部項目。我們以強勁的第四季度總收入 5520 萬美元結束了這一年，與去年同期相比顯著增長了 46%。我們 2022 財年的收入為 1.853 億美元，比 2021 年增長了 20%。

We're off to a great start in 2023. Momentum is building. We are growing revenue, advancing our pipeline, and we're managing our operating expenses. And importantly, we had the capital to fuel sustainable growth and execute on our long-range plan.

我們在 2023 年有了一個良好的開端。勢頭正在增強。我們正在增加收入，推進我們的管道，並且我們正在管理我們的運營費用。重要的是，我們有資金來推動可持續增長並執行我們的長期計劃。

I'm going to start with MRD on Slide 4. clonoSEQ is the gold standard for MRD in blood cancers. Over the last decade, we have built strong moats around clonoSEQ that provide significant competitive advantages, including best-in-class sensitivity, broad coverage, clinical evidence, guideline inclusion, and pharma use as a surrogate endpoint in clinical trials. Now, having nearly doubled our sales force, expanded into DLBCL, and with the forthcoming EPIC integration, it is about execution and driving penetration.

我將從幻燈片 4 上的 MRD 開始。clonoSEQ 是血癌中 MRD 的黃金標準。在過去十年中，我們圍繞 clonoSEQ 建立了強大的護城河，提供了顯著的競爭優勢，包括一流的靈敏度、廣泛的覆蓋範圍、臨床證據、指南納入以及作為臨床試驗替代終點的藥物使用。現在，我們的銷售人員幾乎翻了一番，擴展到 DLBCL，並且隨著即將到來的 EPIC 整合，它與執行和推動滲透有關。

As shown on the graph, clonoSEQ test volumes are growing consistently. Fourth quarter volume grew 9% from third quarter to 10,526 tests delivered. Ordering health care providers and ordering accounts experienced significant growth of 56% and 47%, respectively, versus prior year, and unique patients tested grew 63%. ASP is nearly $1,100 per test, and we expect it to continue to grow annually in the mid-single digits as we finalize pricing agreements with noncontracted payers and improved collection performance.

如圖所示，clonoSEQ 測試量持續增長。第四季度的測試量比第三季度增長了 9%，達到 10,526 次測試。訂購醫療保健提供者和訂購賬戶分別比上一年顯著增長 56% 和 47%，接受測試的獨特患者增長了 63%。每次測試的 ASP 接近 1,100 美元，隨著我們與非簽約付款人敲定定價協議並提高收款性能，我們預計它每年將繼續以中個位數增長。

Our revenue from MRD pharma partnerships, which is a key component of our MRD business, is also growing. Quarterly revenue, excluding regulatory milestones from these partnerships, grew 52% versus prior year and 41% versus prior quarter. This quarter we recognized $2 million milestones from the approval of another multiple myeloma therapy which uses our clonoSEQ assay as a secondary endpoint. We are off to a great start this year with clinical clonoSEQ orders at a record high for us in the past month.

我們來自 MRD 製藥合作夥伴的收入，這是我們 MRD 業務的一個重要組成部分，也在增長。季度收入（不包括這些合作夥伴關係的監管里程碑）比上年增長 52%，比上一季度增長 41%。本季度，我們認識到另一種多發性骨髓瘤療法的批准達到了 200 萬美元的里程碑，該療法使用我們的 clonoSEQ 測定作為次要終點。今年我們有了一個良好的開端，過去一個月的臨床 clonoSEQ 訂單創下歷史新高。

To further increase clonoSEQ penetration, we are focused on a three-pronged strategy shown on Slide 5. First, increased blood-based testing. Blood-based testing will be a catalyst to drive penetration in the community and increase frequency of testing for patients. clonoSEQ is validated and reimbursed in blood in ALL, multiple myeloma, CLL and diffuse large B-cell lymphoma and overall usage of blood in the fourth quarter currently accounts for approximately one-third of all clonoSEQ MRD tests.

為了進一步提高 clonoSEQ 的滲透率，我們專注於幻燈片 5 中顯示的三管齊下的策略。首先，增加基於血液的測試。基於血液的檢測將成為推動社區普及和增加患者檢測頻率的催化劑。 clonoSEQ 在 ALL、多發性骨髓瘤、CLL 和瀰漫性大 B 細胞淋巴瘤的血液中得到驗證和報銷，第四季度血液的總體使用量目前約佔所有 clonoSEQ MRD 測試的三分之一。

In addition, as we increase penetration in CLL and DLBCL, which are primarily blood-based, the overall usage in blood will continue to increase and will catalyze penetration in the community, which now represents 15% of volume versus 12% just last quarter.

此外，隨著我們增加主要基於血液的 CLL 和 DLBCL 的滲透率，血液的總體使用量將繼續增加，並將促進社區滲透，目前佔總量的 15%，而上個季度僅為 12%。

Second, drive growth in DLBCL. We launched clonoSEQ in DLBCL during the ASH Conference in December. DLBCL represents 30% of patients with non-Hodgkin's lymphoma and is an aggressive disease with a high relapse rate. We anticipate DLBCL to be a meaningful contributor in the second half of 2023. Expanding access to clonoSEQ allows physicians to detect relapse sooner and create a more precise treatment plan for each patient. We expect to generate additional data in DLBCL and file with the FDA to support clinical adoption and increase pharma usage.

其次，推動 DLBCL 的增長。我們在 12 月的 ASH 會議期間在 DLBCL 中推出了 clonoSEQ。 DLBCL 佔非霍奇金淋巴瘤患者的 30%，是一種具有高複發率的侵襲性疾病。我們預計 DLBCL 將在 2023 年下半年成為一個有意義的貢獻者。擴大對 clonoSEQ 的訪問允許醫生更快地檢測復發並為每個患者制定更精確的治療計劃。我們希望在 DLBCL 中生成更多數據並向 FDA 提交文件，以支持臨床採用和增加藥物使用。

Third, expand clinical use cases by further demonstrating clinical utility at multiple points along the patient care continuum. You can see on Slide 6, a snapshot of the relevance of MRD testing in patients with blood cancers recently featured at ASH. More than 30 clonoSEQ-related abstracts and multiple presentations reinforce clonoSEQ's ability to provide valuable insights for treatment surveillance, clinical decision making, and continued demonstration of the value that clonoSEQ offers to drug developers.

第三，通過在患者護理連續體的多個點進一步展示臨床實用性來擴展臨床用例。您可以在幻燈片 6 上看到最近在 ASH 上展示的 MRD 檢測與血癌患者相關性的快照。超過 30 個與 clonoSEQ 相關的摘要和多個演示文稿增強了 clonoSEQ 為治療監測、臨床決策制定和持續證明 clonoSEQ 為藥物開發人員提供的價值提供有價值見解的能力。

A rich set of evidence has driven specific use cases that clinicians are incorporating into clinical practice today. Particularly the MASTER trial demonstrates that 90% of standard risk multiple myeloma patients who have 2 consecutive MRD negative results with clonoSEQ can stop treatment and remain cancer free after 2 years. This is an outstanding outcome for patients who can find relief from treatment side effects and also enable substantial savings for the healthcare system.

一組豐富的證據推動了臨床醫生將其納入當今臨床實踐的特定用例。特別是 MASTER 試驗表明，90% 的標準風險多發性骨髓瘤患者使用 clonoSEQ 連續 2 次 MRD 陰性結果可以停止治療並在 2 年後保持無癌狀態。對於可以減輕治療副作用並為醫療保健系統節省大量資金的患者來說，這是一個了不起的結果。

As more studies read out, there will be greater adoption of MRD in the clinic resulting in more patients benefiting from clonoSEQ at multiple time points along their treatment journey. The setup for MRD business is strong, and we are confident that we will achieve significant growth this year.

隨著更多研究的讀出，臨床上將更多地採用 MRD，從而使更多患者在治療過程中的多個時間點受益於 clonoSEQ。 MRD 業務的設置很強大，我們有信心今年將實現顯著增長。

Now turning to Immune Medicine business on Slide 7. Our Immune Medicine business leverages our platform's proprietary ability to sequence, map, and characterize T cell and B cell receptors at scale to drive opportunities in major indications. Growth in Immune Medicine is driven by 2 main areas, pharma services and drug discovery. Through pharma services, we deliver rich and valuable immune receptor data to our biopharma customers that informs biomarkers of response and accelerates their drug development programs. In drug discovery, we are focused on cancer and autoimmune disorders with the goal to advance therapeutics either on our own or with potential partners.

現在轉向幻燈片 7 上的免疫醫學業務。我們的免疫醫學業務利用我們平台的專有能力對 T 細胞和 B 細胞受體進行大規模測序、映射和表徵，以推動主要適應症的機會。免疫醫學的增長由兩個主要領域推動，即製藥服務和藥物發現。通過製藥服務，我們為我們的生物製藥客戶提供豐富而有價值的免疫受體數據，告知生物標誌物反應並加速他們的藥物開發計劃。在藥物發現方面，我們專注於癌症和自身免疫性疾病，目標是通過我們自己或與潛在合作夥伴共同推進治療。

As shown on Slide 8, our strategy in drug discovery is to use our proprietary and differentiated capabilities to discover new drug targets and then develop T cell receptor or antibody therapeutic candidates against those targets. We're already doing this in oncology with our partner Genentech in cell therapy. As shown on Slide 9, we're making good progress with Genentech on 2 cell therapy programs. For both cell therapy products in development under this collaboration, Adaptive validates specific cancer neoantigen targets and then identifies and characterizes potent therapeutic-grade TCRs to those targets. For the first shared TCR candidate selected by Genentech, we are focused on speed to the clinic. In addition, we delivered 2 additional shared TCR data packages for Genentech's consideration.

如幻燈片 8 所示，我們在藥物發現方面的策略是利用我們專有的差異化能力來發現新的藥物靶標，然後開發針對這些靶標的 T 細胞受體或抗體治療候選藥物。我們已經與我們在細胞治療領域的合作夥伴 Genentech 一起在腫瘤學領域開展這項工作。如幻燈片 9 所示，我們與 Genentech 在 2 個細胞治療項目上取得了良好進展。對於此次合作開發的兩種細胞治療產品，Adaptive 驗證特定的癌症新抗原靶點，然後識別和表徵針對這些靶點的有效治療級 TCR。對於 Genentech 選擇的第一個共享 TCR 候選人，我們專注於加快臨床速度。此外，我們還提供了 2 個額外的共享 TCR 數據包供 Genentech 考慮。

On the fully personalized program, having established our prototype with more than 60 patients, we successfully identified and characterized T cell receptors to patient-specific tumor mutations. We also completed end-to-end process runs to start to define early product development. This year, we are focused on standardizing and optimizing our process towards future clinical readiness.

在完全個性化的項目中，我們已經為 60 多名患者建立了原型，我們成功地識別並表徵了針對患者特異性腫瘤突變的 T 細胞受體。我們還完成了端到端流程運行，以開始定義早期產品開發。今年，我們專注於標準化和優化我們的流程，以實現未來的臨床準備。

In addition to our partnered programs which Genentech in cancer, Slide 10 highlights our internal efforts in autoimmune disorders. In this therapeutic area, disease-specific antigens are not well known. We are leveraging our unique capabilities to identify druggable targets in multiple sclerosis and IBD, among others. Next steps are to generate data that validate those targets so we can make progress towards developing therapeutic assets using our TCR and antibody discovery capabilities. We believe drug discovery is another major value driver at Adaptive, and we are excited by the strides we're making with Genentech and our internal programs.

除了基因泰克在癌症方面的合作項目外，幻燈片 10 還強調了我們在自身免疫性疾病方面的內部努力。在這個治療領域，疾病特異性抗原並不為人所知。我們正在利用我們獨特的能力來識別多發性硬化症和 IBD 等的藥物靶點。下一步是生成驗證這些目標的數據，以便我們可以在使用我們的 TCR 和抗體發現能力開發治療資產方面取得進展。我們相信藥物發現是 Adaptive 的另一個主要價值驅動因素，我們對我們在基因泰克和我們的內部項目中取得的進步感到興奮。

I'll now pass it over to Tycho for a financial update.

我現在將它傳遞給 Tycho 進行財務更新。

Thanks, Chad. Starting on Slide 11 with revenue for the fourth quarter and full year. Total revenue in the fourth quarter was $55.2 million with 51% from MRD and 49% from Immune Medicine, representing a 46% increase from the same period last year. MRD revenue of $28.1 million grew 70% from a year ago with clinical testing and MRD pharma partnerships each driving approximately 41% of the growth along with a $2 million increase in MRD regulatory milestones. clonoSEQ test volume, including international, increased by 54% to 10,526 tests delivered from 6,850 tests in the same period last year.

謝謝，乍得。從幻燈片 11 開始，顯示第四季度和全年的收入。第四季度總收入為 5520 萬美元，其中 51% 來自 MRD，49% 來自 Immune Medicine，較去年同期增長 46%。 MRD 收入為 2810 萬美元，比一年前增長了 70%，其中臨床測試和 MRD 製藥合作夥伴各自推動了約 41% 的增長，同時 MRD 監管里程碑增加了 200 萬美元。包括國際在內的 clonoSEQ 測試量從去年同期的 6,850 次測試增加了 54% 至 10,526 次測試。

Immune Medicine revenue was $27.1 million, up 27% from a year ago. This change was driven by a $5.2 million increase from pharma and academic customers, as well as a $2.1 million increase in Genentech amortization, partially offset by a $1.6 million decrease from T-Detect COVID. Total 2022 full year revenue was $185.3 million, representing a 20% year-over-year increase. Looking closer at the full year, MRD revenue was $87.1 million, up 32% from a year ago, driven by a $15.8 million increase in clonoSEQ clinical testing and $10 million increase in MRD pharma, partially offset by a $4 million decrease in MRD regulatory milestones. Immune Medicine revenue grew to $98.2 million, up 11% versus the prior year, driven by a $13.6 million increase from pharma services, partially offset by a $4.4 million decrease from T-Detect COVID.

免疫醫學收入為 2710 萬美元，同比增長 27%。這一變化是由製藥和學術客戶增加 520 萬美元，以及基因泰克攤銷增加 210 萬美元，部分被 T-Detect COVID 減少 160 萬美元所抵消。 2022 年全年總收入為 1.853 億美元，同比增長 20%。仔細觀察全年，MRD 收入為 8710 萬美元，比一年前增長 32%，這主要受 clonoSEQ 臨床測試增加 1580 萬美元和 MRD 製藥增加 1000 萬美元的推動，部分被 MRD 監管里程碑減少 400 萬美元所抵消.免疫醫學收入增長至 9820 萬美元，比上年增長 11%，這主要得益於製藥服務增加 1360 萬美元，部分被 T-Detect COVID 減少 440 萬美元所抵消。

Now moving on to operating expenses on Slide 12. We continue to place a strong emphasis on leveraging our OpEx. Total operating expenses for the fourth quarter were $94.4 million, representing a 5% decrease from $99.5 million in the same period last year. Cost of revenue was $16.6 million compared to $14.4 million last year, representing a 16% increase. R&D expenses were $31.2 million compared to $34.7 million last year, representing a 10% decrease. Sales and marketing expenses were $23.7 million compared to $26.7 million last year, representing an 11% decrease largely due to reduced clonoSEQ and T-Detect marketing activities. General and administrative expenses for the quarter were $22.4 million compared to $23.3 million a year ago, representing a 4% decrease. Lastly, interest expense from a royalty financing agreement with OrbiMed was $3.6 million.

現在轉到幻燈片 12 的運營費用。我們繼續高度重視利用我們的運營支出。第四季度總運營費用為 9440 萬美元，比去年同期的 9950 萬美元減少 5%。收入成本為 1660 萬美元，而去年為 1440 萬美元，增長了 16%。研發費用為 3120 萬美元，與去年的 3470 萬美元相比下降了 10%。銷售和營銷費用為 2370 萬美元，而去年為 2670 萬美元，下降了 11%，這主要是由於 clonoSEQ 和 T-Detect 營銷活動的減少。本季度的一般和行政費用為 2240 萬美元，與去年同期的 2330 萬美元相比下降了 4%。最後，與 OrbiMed 簽訂的特許權使用費融資協議的利息支出為 360 萬美元。

Net loss for the quarter was $40.2 million compared to $61.4 million last year. For the full year, total operating expenses were $385.5 million compared to $363.3 million in 2021, with the 6% increase primarily driven by higher G&A and cost of revenue. Importantly, the 6% increase represents a significant reduction in our OpEx growth of 45% from the prior year while still achieving meaningful revenue growth from our core revenue segments. Full year 2022 net loss was $200.4 million compared to $207.3 million in 2021, while adjusted EBITDA was a loss of $121.6 million compared to a loss of $151.7 million in 2021. We ended the year with approximately $498 million in cash, equivalents, and marketable securities, giving us over 3 years of cushion on the balance sheet. As Chad noted before, we expect this will carry us through to profitability without having to raise additional capital.

本季度淨虧損為 4020 萬美元，而去年同期為 6140 萬美元。全年總運營費用為 3.855 億美元，而 2021 年為 3.633 億美元，增長 6% 的主要原因是 G&A 和收入成本增加。重要的是，6% 的增長意味著我們的運營支出增長率比上一年顯著下降了 45%，同時我們的核心收入部門仍實現了有意義的收入增長。 2022 年全年淨虧損為 2.004 億美元，而 2021 年為 2.073 億美元，而調整後的 EBITDA 為虧損 1.216 億美元，而 2021 年為虧損 1.517 億美元。到年底，我們的現金、等價物和有價證券約為 4.98 億美元，為我們的資產負債表提供了超過 3 年的緩衝。正如乍得之前指出的那樣，我們預計這將使我們在無需籌集額外資金的情況下實現盈利。

Now turning to our outlook for 2023 on Slide 13. We expect full year revenue to be in the range of $205 million to $215 million. At the midpoint, we anticipate the contribution from our businesses to be approximately 55% from MRD and 45% from Immune Medicine, with a lower contribution from Immune Medicine mainly driven by significantly lower amortization from the Genentech upfront versus prior years. Our MRD business estimates include over 50% growth in clonoSEQ test volumes and a continued ASP increase in the mid-single-digit range.

現在轉向我們在幻燈片 13 上對 2023 年的展望。我們預計全年收入將在 2.05 億美元至 2.15 億美元之間。在中點，我們預計我們業務的貢獻約為 MRD 的 55% 和免疫醫學的 45%，免疫醫學的貢獻較低主要是由於 Genentech 的前期攤銷與前幾年相比顯著降低。我們的 MRD 業務估計包括 clonoSEQ 測試量增長超過 50% 和 ASP 在中個位數範圍內的持續增長。

In addition, we anticipate MRD milestones in the mid-to-high single-digit millions. With respect to trends over the year, we expect revenue to be back-half weighted and Q1 to be the lowest of the year. This is due to several factors, including normal seasonality reflected in the low first quarter and high fourth quarter; uptake in MRD from the clonoSEQ DLBCL launch and EPIC integration which are expected in the back half of the year; and milestones in both Immune Medicine and MRD, which are expected by year-end.

此外，我們預計 MRD 里程碑將達到中高個位數百萬。關於全年趨勢，我們預計收入將進行後半加權，第一季度將是今年最低的。這是由幾個因素造成的，包括第一季度低和第四季度高反映的正常季節性；預計在今年下半年推出的 clonoSEQ DLBCL 和 EPIC 整合對 MRD 的吸收；預計在年底前實現免疫醫學和 MRD 的里程碑。

Regarding operating expenses, we expect 2023 OpEx, including cost of revenue to be slightly below our 2022 OpEx of $385.5 million. This reflects our ongoing efforts to drive operating efficiencies while investing behind the projects to support our growth profile with higher returns. We're continuing to be thoughtful about our cash deployment and expect our burn to be an average of $40 million per quarter.

關於運營費用，我們預計 2023 年的運營支出（包括收入成本）將略低於我們 2022 年的 3.855 億美元運營支出。這反映了我們不斷努力提高運營效率，同時對項目進行投資，以支持我們的增長模式並獲得更高的回報。我們將繼續深思熟慮我們的現金部署，並預計我們每季度平均消耗 4000 萬美元。

We had solid performance in 2022. We are growing revenues, managing our operating expenses, and we have a strong capital position to fuel growth and execute on our goals. With that, I'll hand it back over to Chad.

我們在 2022 年取得了穩健的業績。我們正在增加收入，管理我們的運營費用，並且我們擁有強大的資本狀況來推動增長和實現我們的目標。有了這個，我會把它交還給乍得。

Thanks, Tycho. As highlighted during the call and shown on Slide 14, we have several key milestones for 2023. We're off to a running start, and I'm confident in our ability to accelerate clonoSEQ penetration in our MRD business and to demonstrate our drug discovery capabilities in Immune Medicine.

謝謝，第谷。正如在電話會議期間和幻燈片 14 中所強調的那樣，我們有幾個 2023 年的關鍵里程碑。我們已經開始了，我相信我們有能力加速 clonoSEQ 在我們的 MRD 業務中的滲透並展示我們的藥物發現免疫醫學能力。

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

有了這個，我想把電話轉回給接線員並公開提問。

(Operator Instructions) And our first question comes from Derik De Bruin from Bank of America.

（操作員說明）我們的第一個問題來自美國銀行的 Derik De Bruin。

So can you talk a little bit about revenue pacing? Obviously, you've got DCBCL (sic) [DLBCL] coming in the back half. How should we think about -- I realize Q1 is going to be your lowest due to seasonality and other things, but just some quarter-to-quarter progression if you've got on revenues and volumes, it would be helpful.

那麼你能談談收入節奏嗎？顯然，你有 DCBCL (sic) [DLBCL] 進入後半部分。我們應該如何考慮——我意識到由於季節性和其他因素，第一季度將是最低的，但如果你有收入和銷量，只是一些季度到季度的進展，這會有所幫助。

Yes. As you noted, first quarter will be the low. The DLBCL launch and the EPIC integration are back half drivers for sure. And then if you look at the range we laid out, there are some variables in there, which maybe I'll spend a minute on. On the MRD side, we guided conservatively on milestones, so that could be a swing factor as we go through the year. It could drive things to the high or low end of the range, depending on the magnitude of the milestones. We've got roughly $370 million in future milestones, as we've talked about in the past, line of sight to about half of those. And we risk adjust those in our guidance with about a 30% to 50% probability of success. So that's one swing factor.

是的。正如您所指出的，第一季度將是低點。 DLBCL 的推出和 EPIC 的整合無疑是後半部分的驅動力。然後，如果您查看我們列出的範圍，就會發現其中有一些變量，也許我會花一點時間。在 MRD 方面，我們對里程碑進行了保守指導，因此這可能成為我們度過這一年的一個搖擺因素。它可以將事情推向范圍的高端或低端，具體取決於里程碑的大小。正如我們過去所討論的那樣，我們在未來的里程碑中獲得了大約 3.7 億美元的資金，其中約一半的視線。我們冒險調整我們指導中的那些，有大約 30% 到 50% 的成功概率。所以這是一個搖擺因素。

The IND acceptance for Immune Medicine, obviously, a big swing factor towards the end of the year. And that's the biggest swing factor in the fourth quarter. And as a reminder, on Genentech, we recognized $7 million of the $10 million upfront on the acceptance of that milestone. So that gives you -- we're not going to give quarterly guidance, but that gives you some flavor as to the drivers in the back half of the year that are going to lead to accelerating growth as we progress through the year.

免疫醫學的 IND 接受顯然是年底的一個重大搖擺因素。這是第四季度最大的搖擺因素。提醒一下，在 Genentech 上，我們在接受該里程碑時確認了 1000 萬美元預付款中的 700 萬美元。所以這給了你——我們不會給出季度指導，但這會讓你對下半年的驅動因素有所了解，隨著我們今年的進展，這些驅動因素將導致加速增長。

Great. That's helpful. And on the greater than 50% volume growth in clonoSEQ, it's a little bit below what we were looking for. Just some commentary on trends and basically any residuals like headwinds in the market, patient access -- not patient access, the doc access. Just any sort of commentary on trends -- volume trends.

偉大的。這很有幫助。在 clonoSEQ 超過 50% 的銷量增長方面，它略低於我們的預期。只是對趨勢的一些評論，基本上是任何殘留物，如市場逆風、患者訪問——而不是患者訪問、醫生訪問。只是對趨勢的任何評論——數量趨勢。

No. Actually, Derik, as I had mentioned, we're seeing record volumes to start the year. And so we wanted people to be conservative in putting that out. Greater than 50% leaves a lot of room on the upside too. So we're putting that out there. It's a watermark to hit. We feel very confident that we're going to be able to achieve that number and believe that another swing factor that there could be some upside there.

沒有。實際上，Derik，正如我所提到的，今年年初我們看到了創紀錄的銷量。因此，我們希望人們在發佈時保持保守。超過 50% 也留下了很大的上行空間。所以我們把它放在那裡。這是一個水印。我們非常有信心我們將能夠達到這個數字，並相信另一個搖擺因素可能會有一些上行空間。

And our next question comes from David Westenberg from Piper Sandler.

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

I'm actually at the other side of Derik here because one of the battlegrounds we get is in that 50% volume here. Can you maybe talk about -- same kind of concept. Can you talk about, you're now on a mid-50s comp here in terms of growth rate. So you do have a tough comp on the volume growth coming in, in 2023. I think EPIC and DLBCL are happening in the back half. So give us maybe a little bit more conceptualization of beating that tough comp. And really what does EPIC and DLBCL contribute from an incremental standpoint because I do think it means that they do help you overcome that comp.

我實際上在 Derik 的另一邊，因為我們獲得的戰場之一是這裡的 50% 音量。你能不能談談——同樣的概念。你能談談嗎，就增長率而言，你現在處於 50 年代中期。所以你對 2023 年的銷量增長確實有一個艱難的比較。我認為 EPIC 和 DLBCL 正在後半段發生。因此，請給我們更多有關擊敗強硬對手的概念。從增量的角度來看，EPIC 和 DLBCL 實際上有什麼貢獻，因為我確實認為這意味著它們確實可以幫助您克服這種困難。

Sure. David, I'm going to turn this over to Nitin Sood, who runs our MRD business and calling in from San Francisco.

當然。大衛，我要把這件事交給 Nitin Sood，他負責我們的 MRD 業務，從舊金山打來電話。

Yes. I think, first of all, I just want to remind everyone that our current penetration is about 5%. So there's a lot of room for us to grow. As Chad mentioned, 2023 is off to a very strong start. And I'm very confident that we grow volumes at greater than 50% off a larger base business this year. And that combined with ASP increase, which we are seeing steadily, we'll see revenue increase by 60%. A few things I want to point out, as you know our focus and growth strategy has been in the U.S. twofold, to drive deeper penetration and to increase business in the community. Over the last few quarters, we've seen our orders per account and institutional accounts increase by 30%. Our community business has grown from 8% of our total business to 15%, and I expect that to be 20% of our 2023 business. And all leading indicators are looking favorable. New HCPs accounts grew by 50%, unique patients tested grew by 60%. Multiple myeloma, which is a key growth driver for us, continues to deliver.

是的。我想，首先，我只是想提醒大家，我們目前的滲透率大約是5%。所以我們有很大的成長空間。正如乍得所提到的，2023 年的開局非常強勁。而且我非常有信心，我們今年的銷量增長超過了更大的基礎業務的 50%。再加上我們看到穩定的平均售價增長，我們將看到收入增長 60%。我想指出幾件事，正如你所知，我們的重點和增長戰略在美國是雙重的，以推動更深層次的滲透並增加社區業務。在過去的幾個季度中，我們看到每個賬戶和機構賬戶的訂單增加了 30%。我們的社區業務已從占總業務的 8% 增長到 15%，我預計到 2023 年將占我們業務的 20%。所有領先指標都看好。新的 HCP 賬戶增長了 50%，接受測試的獨特患者增長了 60%。多發性骨髓瘤是我們的主要增長動力，繼續交付。

And we've had some very significant data readouts this year, MASTER, DETERMINATION. And then finally, the increased reach and effectiveness of our sales team is coming into play, and we'll fully deliver in 2023. So over and above DLBCL and EPIC, there's a lot of growth catalysts, and I expect our growth -- very confidently that we'll grow above 50% in this year and even beyond.

今年我們有一些非常重要的數據讀數，MASTER，DETERMINATION。最後，我們銷售團隊的影響力和效率的提高正在發揮作用，我們將在 2023 年全面交付。因此，除了 DLBCL 和 EPIC 之外，還有很多增長催化劑，我預計我們的增長——非常我們有信心在今年甚至以後實現 50% 以上的增長。

Got it. I noticed you have 10 analysts here, so I'm just going to ask one more since you probably have a lot more questions here. You did keep burn rate or expenses I think you said were flat. I respect that you're probably going to [grow] revenue, which basically means you are going to have to have sales -- compensation for sales people that are hitting their numbers, bonuses, just the natural cost of goods sold that are associated with higher revenue here. So can you give us a little sense on where you have cuts remaining in 2023 given the fact that I think that you will grow in the year and you're holding OpEx steady?

知道了。我注意到你們這裡有 10 位分析師，所以我只想再問一位，因為你們這裡可能有更多問題。你確實保持了燃燒率或費用，我認為你說的是持平的。我尊重你可能會 [增加] 收入，這基本上意味著你將不得不進行銷售 - 對達到他們數量的銷售人員的補償，獎金，只是與相關的銷售商品的自然成本這裡的收入更高。那麼，鑑於我認為您將在這一年增長並且您保持 OpEx 穩定，您能否讓我們了解一下您在 2023 年還有哪些削減？

Sure. So, a couple things. Yes, the cash burn guidance is $40 million on average for the year. Q1 will be higher due to the bonus payouts. We had a pretty low quarter in the fourth quarter. There was favorable working capital, low CapEx spending, and high investment income. So we're coming off a low burn on the fourth quarter, but 1Q will be a pretty significant step up.

當然。所以，有幾件事。是的，全年的現金消耗指導平均為 4000 萬美元。由於獎金支付，Q1 會更高。我們在第四季度的表現非常低迷。有良好的營運資金、低資本支出和高投資收益。所以我們在第四季度的低燒，但 1Q 將是一個非常重要的進步。

If we look at total OpEx overall, we spent just over $385 million, including cost of revenue last year. Some of the areas we've talked about in prior calls, workflow enhancement, leveraging lower sequencing costs, DNA extraction costs, cloud compute, real estate, these are all ongoing initiatives. We've done a lot of work around R&D as well. We've mapped projects to revenue or margin enhancement opportunities, and there's some leverage there that we've seen similarly with G&A. And then we're doing a lot of work on gross margins now. We'll have more to say on that at some point in the future, but this is an area where we do see significant potential as we scale. So the important thing about OpEx is it's not coming from a single area. It's all parts of the company. There's been a real cultural shift underway here at Adaptive and really there are no sacred cows. So we continue to look for opportunities to get more efficient and better as a company going forward, but it's across all parts of the business.

如果我們看一下總體運營支出，我們的支出剛剛超過 3.85 億美元，包括去年的收入成本。我們在之前的電話會議中討論過的一些領域、工作流程增強、利用較低的測序成本、DNA 提取成本、雲計算、房地產，這些都是正在進行的舉措。我們也圍繞研發做了很多工作。我們已將項目映射到收入或提高利潤率的機會，並且我們在 G&A 中看到了類似的槓桿作用。然後我們現在正在做很多關於毛利率的工作。在未來的某個時候，我們會有更多的話要說，但隨著我們的擴展，這是一個我們確實看到了巨大潛力的領域。所以關於 OpEx 的重要一點是它不是來自單一區域。都是公司的一部分。 Adaptive 正在發生真正的文化轉變，而且真的沒有什麼神聖不可侵犯的東西。因此，我們繼續尋找機會，以提高公司的效率和發展水平，但它涉及到業務的各個方面。

Congrats on the good print.

恭喜印刷精美。

And our next question comes from Daniel Brennan from Cowen.

我們的下一個問題來自 Cowen 的 Daniel Brennan。

Maybe just the first one would just be, as we think about the '23 guide, the immunoSEQ academic and pharma, and then as well on what's implied for MRD pharma. Just give us a sense of -- obviously, these are fast-growing businesses, but hard for us to see underneath the hood. Obviously, there's a lot happening. So just what's implied in '23? And what's the visibility on that outlook?

正如我們考慮 23 年指南、immunoSEQ 學術和製藥，以及對 MRD 製藥的暗示，也許只是第一個。只是給我們一種感覺 - 顯然，這些是快速增長的業務，但我們很難在引擎蓋下看到。顯然，發生了很多事情。那麼'23'中暗示了什麼？該前景的可見度如何？

Yes, Tycho, you want to take it?

是的，第谷，你想接受嗎？

Yes. We're not going to give specific guidance around immunoSEQ or academic or some of the subsegments. Sharon, is there anything specifically you want to say on immune for your part of the business, then maybe we'll put it over to Nitin as well. But we're not going to guide specifically on subsegments.

是的。我們不會就 immunoSEQ 或學術或某些子部分提供具體指導。莎倫，對於你的業務部分，你有什麼特別想對免疫說的嗎，也許我們也會把它交給 Nitin。但我們不會專門針對細分市場進行指導。

Yes, happy to expand. Again, it's about execution. As we said, our strategy is to increase penetration with our portfolio of pharma companies and biotechs in later and larger stage clinical trials in really 4 major indications. And so we're head down, focused on doing that to generate revenue, meet our guidance.

是的，很高興擴大。再次，這是關於執行。正如我們所說，我們的戰略是在 4 個主要適應症的後期和更大規模臨床試驗中提高我們的製藥公司和生物技術組合的滲透率。所以我們低著頭，專注於創造收入，滿足我們的指導。

And just so -- again, at the midpoint of the range here, Immune Medicine is about 45%, so that implies $95 million. The Genentech amortization is a big headwind for that business, right? It's $30 million, $35 million this year versus north of $60 million last year. So that's something that has to be factored in. And at pharma services, we've publicly talked about that business growing at a 20%-plus CAGR in the long run. So that gives you some sense of how we're thinking about it. And then there's a milestone we talked about earlier with Genentech towards the end of the year.

正是如此——同樣，在此範圍的中點，免疫醫學約為 45%，這意味著 9500 萬美元。 Genentech 的攤銷對該業務來說是一個很大的阻力，對吧？這是 3000 萬美元，今年是 3500 萬美元，而去年是 6000 萬美元。所以這是必須考慮的因素。在製藥服務方面，我們公開談論過該業務從長遠來看以 20% 以上的複合年增長率增長。這樣您就可以了解我們是如何考慮它的。然後我們在年底前與基因泰克討論了一個里程碑。

MRD 55% is the range at the midpoint. That implies about $115 million. We talked earlier about volume growth of 50% for clonoSEQ and mid-single-digit ASP growth. Milestones there, I mentioned earlier, are going to be in the mid-to-high millions. And then you've got the MRD pharma sequences business around $45 million, growth of about 10% at the midpoint. Nitin, anything you'd add to that?

MRD 55% 是中點的範圍。這意味著大約 1.15 億美元。我們之前談到了 clonoSEQ 50% 的銷量增長和中等個位數的 ASP 增長。我之前提到過，那裡的里程碑將達到中百萬。然後你有大約 4500 萬美元的 MRD 製藥序列業務，中點增長約 10%。 Nitin，你還有什麼要補充的嗎？

No, I think I'll just only point out that this is for the first time our clinical diagnostics business is a key growth driver, and it's going to be larger than our pharma business in MRD. So it's a pretty exciting year for us in 2023.

不，我想我只想指出，這是我們的臨床診斷業務第一次成為關鍵的增長動力，而且它的規模將超過我們在 MRD 方面的製藥業務。因此，2023 年對我們來說是非常激動人心的一年。

And maybe one quick follow-up. Just in terms of the clinical trials and the adoption in blood, what's the -- are there any important milestones -- not milestones in terms of dollar milestones, but in terms of events in these trials such that it would lead to maybe a more meaningful proven impact such that you could see a greater ability to market it to doctors. I know that we spoke to a few doctors and they're looking for continued data to mature over time. So will any of that be happening in '23 or it's just an ongoing basis?

也許一個快速的跟進。就臨床試驗和血液採用而言，有什麼重要的里程碑 - 不是美元里程碑方面的里程碑，而是這些試驗中的事件，這樣它可能會導致更有意義經證明的影響，這樣你就可以看到更大的能力將它推銷給醫生。我知道我們與幾位醫生交談過，他們正在尋找持續的數據以隨著時間的推移而成熟。那麼這些事情會在 23 年發生，還是只是一個持續的基礎？

Go ahead, Nitin.

去吧，尼丁。

Yes. So I think first, I just want to remind everyone that we are selling in blood today. 30% of all MRD tests are in blood. DLBCL and CLL are blood tests primarily. 26% of all ALL tests are in blood. Multiple myeloma used to be primarily a bone marrow test; however, now 12% of all tests in multiple myeloma are in blood, and this is increasing. And the use case for blood is simple in the case of multiple myeloma. When the test is positive in blood, your cancer is there. Treat the patient, make it negative in blood, and then verify annually in bone marrow.

是的。所以我想首先，我只是想提醒大家，我們今天是在賣血。所有 MRD 測試中有 30% 是在血液中進行的。 DLBCL和CLL主要是驗血。所有 ALL 測試中有 26% 是血液測試。多發性骨髓瘤過去主要是骨髓檢查；然而，現在多發性骨髓瘤的所有檢測中有 12% 是血液檢測，而且這一比例還在增加。在多發性骨髓瘤的情況下，血液的用例很簡單。當血液測試呈陽性時，您的癌症就在那裡。治療患者，使其在血液中呈陰性，然後每年在骨髓中進行驗證。

On top of this, we're conducting additional studies in blood to strengthen our evidence and to demonstrate that we're better than other biomarkers in blood. We expect to have data for multiple myeloma readout at the International Myeloma Society in September and ASH in December. And then we have data also for CLL and DLBCL reading out. DLBCL we have a major conference coming up in June. So we're executing commercially, and we'll have additional data, and I expect blood volumes to go up.

除此之外，我們正在對血液進行額外的研究，以加強我們的證據並證明我們比血液中的其他生物標誌物更好。我們預計將在 9 月的國際骨髓瘤協會和 12 月的 ASH 上獲得多發性骨髓瘤的數據。然後我們還有用於 CLL 和 DLBCL 讀出的數據。 DLBCL 我們將在 6 月召開一次重要會議。所以我們正在商業上執行，我們將有更多的數據，我預計血液量會增加。

And our next question comes from Julia Qin from Cowen.

我們的下一個問題來自 Cowen 的 Julia Qin。

It's Julia from JPMorgan. So looks like in this 4Q, your clonoSEQ ASP of $1,100 ramped up faster than what we were modeling. So could you maybe give us an update on your private payer conversation so far? And why is it not possible for us to see ASP accretion above that mid-single-digit growth that you're guiding to?

我是來自摩根大通的 Julia。所以看起來在這個第四季度，你的 clonoSEQ ASP 為 1,100 美元，比我們建模的速度更快。那麼，您能否向我們介紹一下您到目前為止的私人付款人談話的最新情況？為什麼我們不可能看到 ASP 增長超過您所指導的中個位數增長？

Go ahead, Nitin.

去吧，尼丁。

Yes. I think we've seen a steady ASP growth for clonoSEQ over the past couple of years, and we anticipate that growth to continue in the mid-single-digit range over the next 2 to 3 years and trend towards $1,700 per test, which we have as the contracted rate with private payers. We continue to invest in getting additional pricing agreements with noncontracted payers, including large Medicaid plans where we've seen a lot of usage of clonoSEQ recently. We're improving our collection performance. So we're going to invest in that area this year. And then we are also going after some of the expanded coverage for new indications like DLBCL. DLBCL we have Medicare coverage only, but this year we expect to expand that into private payer coverage. And then we have minor indications like MCR and CTCL that we need coverage on. So a lot of things are happening, and we expect ASP to grow steadily towards $1,700 in the next few years.

是的。我認為我們在過去幾年中看到了 clonoSEQ 的穩定 ASP 增長，我們預計在未來 2 到 3 年內增長將繼續保持在中等個位數範圍內，並趨向於每次測試 1,700 美元，我們具有與私人付款人的合同費率。我們繼續投資與非合同付款人簽訂額外的定價協議，包括我們最近看到大量使用 clonoSEQ 的大型醫療補助計劃。我們正在改進我們的收集性能。所以我們今年打算在那個領域投資。然後，我們還將針對 DLBCL 等新適應症擴大覆蓋範圍。 DLBCL 我們只有 Medicare 保險，但今年我們希望將其擴展到私人支付保險。然後我們有一些小跡象，如 MCR 和 CTCL，我們需要報導。所以很多事情都在發生，我們預計 ASP 在未來幾年內將穩步增長至 1,700 美元。

Great. And then on the Immune Medicine side for Genentech, you mentioned that your focus for this year on the first candidate is speed to clinic. Can you elaborate on what can Adaptive do to speed up that process and what kind of timeline we should be thinking about? And then for those 2 additional TCR data packages, what's the timeline for Genentech making a decision on those?

偉大的。然後在基因泰克的免疫醫學方面，你提到你今年對第一個候選人的關注是加快臨床。您能否詳細說明 Adaptive 可以做什麼來加快該過程以及我們應該考慮什麼樣的時間表？然後對於這 2 個額外的 TCR 數據包，Genentech 對它們做出決定的時間表是什麼時候？

So for Genentech, they control the timing of the filing and, obviously, interactions directly with FDA when they do file. And so that's ongoing. We're very optimistic and are working closely to support it along the way. As it relates to the 2 additional TCR data packages that we completed and delivered at the end of last year, those are being reviewed together jointly by the working teams. And obviously, we will update in terms of any progress to advance those as potential therapeutic product candidates.

因此，對於 Genentech，他們控制著提交文件的時間，並且很明顯，他們在提交文件時直接與 FDA 進行交互。所以這是正在進行的。我們非常樂觀，並正在密切合作以支持它。由於它涉及我們在去年年底完成並交付的另外 2 個 TCR 數據包，因此工作團隊正在共同審查這些數據包。顯然，我們將更新任何進展，以將這些進展作為潛在的治療產品候選者。

And our next question comes from Mark Massaro from BTIG.

我們的下一個問題來自 BTIG 的 Mark Massaro。

So I wanted to maybe ask a follow-up question. I know it's sort of been asked, but as we think about anniversarying a relatively challenging comp and a 50% growth is really pretty elite in diagnostics. So it seems to me that the key variable in the back half of the year is the DLBCL launch, just to give people confidence that you can exceed 50% again this year. But the one thing that I don't think I've heard is like how should we think about the incremental contribution from DLBCL, and any way for us to think about it in terms of market penetration or early access interest or anything of that variety?

所以我想問一個後續問題。我知道有人問過這個問題，但當我們考慮週年紀念時，一個相對具有挑戰性的公司和 50% 的增長在診斷方面確實是非常優秀的。所以在我看來，下半年的關鍵變量是 DLBCL 推出，只是為了讓人們相信今年你可以再次超過 50%。但是我認為我沒有聽說過的一件事是我們應該如何考慮 DLBCL 的增量貢獻，以及我們在市場滲透或早期訪問興趣或任何其他方面考慮它的任何方式？

Yes. Mark, I'm going to take this because while DLBCL is 1 component, it's really not only the multipronged strategy that we laid out, but there are just major levers across the board, including increasing penetration in the community setting. Our team has done a lot of work in defining pathways. And we've done -- really had success as of late in penetrating some of the larger community practice accounts that have taken a long time to crack. We also mentioned EPIC integration in the back half of the year. I think that -- really being able to go right into your EHR and order directly from there should -- especially on accounts that are already ordering clonoSEQ, we think that should accelerate usage.

是的。馬克，我要接受這個，因為雖然 DLBCL 是一個組成部分，但它實際上不僅是我們制定的多管齊下的戰略，而且還有全面的主要槓桿，包括增加社區環境中的滲透率。我們的團隊在定義路徑方面做了大量工作。我們已經完成了——最近真的成功地滲透了一些需要很長時間才能破解的較大的社區實踐賬戶。我們還提到了下半年的 EPIC 集成。我認為——真的能夠直接進入你的 EHR 並直接從那裡訂購——特別是對於已經訂購 clonoSEQ 的賬戶，我們認為這應該會加速使用。

In terms of increasing clinical utility, the previous question on blood-based usage in multiple myeloma and the readouts that we have coming, I think that will continue. The additional use cases for discontinuation of maintenance therapy as you get more and more data from the MASTER trial and the MRD2STOP trial and others that are reading out.

在增加臨床效用方面，之前關於多發性骨髓瘤中基於血液的使用的問題以及我們即將到來的讀數，我認為這將繼續下去。隨著您從 MASTER 試驗和 MRD2STOP 試驗以及正在讀取的其他試驗中獲得越來越多的數據，停止維持治療的其他用例。

And then I'll make an overall comment that I think I'm seeing -- and I don't know if we can agree on this. But MRD, in general, is becoming a much more accepted within -- by health care providers. It took a long time to get here. I actually think even a lot of the noise around MRD in solid tumors and just the nomenclature and understanding what the assay is. And no one wants to be first, but no one also wants to be last. And we're hitting that -- I would say, starting to hit that point where it's become more common practice, and that's obviously what we're trying to get to where it's something you do on every patient that has one of these hematological malignancies that our test applies to. So I think it's a variety of factors that gives us confidence that we're going to be able to hit that 50% number in 2023.

然後我會發表一個我認為我正在看到的總體評論——我不知道我們是否可以就此達成一致。但總的來說，MRD 正變得越來越被醫療保健提供者所接受。花了很長時間才到這裡。實際上，我什至認為實體瘤中 MRD 周圍有很多噪音，只是命名法和對檢測方法的理解。沒有人想成為第一，但也沒有人想成為最後。我們正在達到這個目標——我想說，開始達到它變得更普遍的地步，這顯然是我們正在努力達到的目標，即你對每個患有這些血液惡性腫瘤之一的患者所做的事情我們的測試適用於。所以我認為有多種因素讓我們有信心在 2023 年達到 50% 的數字。

And Mark, just to add to that a little bit. In multiple myeloma, which is our biggest growth driver, we're less than 10% penetrated. So there's a lot of room for us to grow. In CLL, we're less than 5% penetrated. So even in the existing diseases, we have a lot of room to grow. And then lastly, I think, we expect -- sales seem to be twice as more productive this year than last year. Last year we increased the size of the sales team, we deployed them in various territories, and in community, our penetration is extremely [low]. So there's a lot of growth drivers other than DLBCL. And yes, the 50% comp is above what other diagnostic companies do, but I think we have the best product in heme MRD, and we have a great team in place.

馬克，只是為了補充一點。在我們最大的增長動力多發性骨髓瘤中，我們的滲透率不到 10%。所以我們有很大的成長空間。在 CLL 中，我們的滲透率不到 5%。因此，即使在現有疾病中，我們也有很大的成長空間。最後，我認為，我們預計今年的銷售量似乎是去年的兩倍。去年我們增加了銷售團隊的規模，將他們部署在各個地區，在社區中，我們的滲透率極低。因此，除了 DLBCL 之外，還有很多增長動力。是的，50% 的補償高於其他診斷公司所做的，但我認為我們在血紅素 MRD 方面擁有最好的產品，而且我們擁有一支優秀的團隊。

Okay. Excellent. So I also wanted to ask about -- just to confirm the T-Detect initiative, should we assume that that's effectively paused because I guess I'm also trying to arrive at how the OpEx can be lower while the top line is growing. So maybe, Tycho, if you could walk us through any of the buckets. Presumably, G&A may be up a little bit, sales and marketing may be up a little bit. Should we assume R&D is likely down?

好的。出色的。所以我也想問 - 只是為了確認 T-Detect 計劃，我們是否應該假設它已經有效暫停，因為我想我也在試圖弄清楚 OpEx 如何在收入增長的同時降低。所以也許，第谷，如果你能帶我們走過任何一個水桶。據推測，G&A 可能會上漲一點，銷售和營銷可能會上漲一點。我們是否應該假設研發可能會下降？

Yes. Look, as I said earlier, we're working on getting leverage across the company. And yes, G&A, for sure, we've got some leverage. Sales and marketing, a little bit, but to Nitin's point a minute ago, we did double the sales force last year, so you've got to keep that in mind. And then, yes, there is R&D leverage. I mentioned earlier, we went through a very thorough process over the summer of mapping out every R&D project. And with that in mind, there was some stuff that dropped out that wasn't necessarily mapping to revenue or margin opportunities, so we do have R&D leverage as well.

是的。看，正如我之前所說，我們正在努力在整個公司發揮影響力。是的，G&A，當然，我們有一些影響力。銷售和市場營銷，一點點，但就尼廷一分鐘前的觀點而言，我們去年的銷售人員翻了一番，所以你必須記住這一點。然後，是的，還有研發槓桿。我之前提到過，我們在整個夏天都經歷了一個非常徹底的過程來規劃每個研發項目。考慮到這一點，有些東西被丟棄了，不一定映射到收入或利潤機會，所以我們也有研發槓桿。

And then just in terms of your question directly on T-Detect, Mark, as you know, we made the decision in 2022 to delay commercialization efforts of T-Detect as a diagnostic test until we have strong enough signal data that can change physician behavior with a clear path to reimbursement. But that said, we have this really nice opportunity to leverage the data and continue to develop that antigen mapping data for both pharma services and in our internal efforts in drug discovery. One of the -- if you look at probability of success of therapies that are tied to an effective biomarker that can stratify patient populations, this is exactly the strategy that we're hoping to deploy with our antigen mapping efforts in developing those signals.

然後就你直接在 T-Detect 上提出的問題而言，馬克，如你所知，我們在 2022 年決定推遲將 T-Detect 作為診斷測試的商業化工作，直到我們有足夠強大的信號數據來改變醫生的行為有明確的報銷途徑。但話雖如此，我們有這個非常好的機會來利用數據並繼續為製藥服務和我們在藥物發現方面的內部努力開發抗原圖譜數據。其中之一 - 如果您查看與可以對患者人群進行分層的有效生物標誌物相關的治療成功的可能性，這正是我們希望通過我們的抗原定位工作來開發這些信號的策略。

And our next question comes from Salveen Richter from Goldman Sachs.

我們的下一個問題來自高盛的 Salveen Richter。

This is Elizabeth on for Salveen. When should we consider proof-of-concept being achieved for the drug discovery efforts? Do you think that would be this year upon IND acceptance for the first shared product? Just curious how you're thinking of proof-of-concept generation there? And then could you remind us of the timelines around the personalized T cell therapy and when that could -- I guess, what the next milestones are for that.

這是薩爾文的伊麗莎白。我們什麼時候應該考慮為藥物發現工作實現概念驗證？您是否認為今年會在 IND 接受第一個共享產品後？只是好奇您是如何考慮那裡的概念驗證生成的？然後你能否提醒我們關於個性化 T 細胞療法的時間表以及何時可以 - 我猜，下一個里程碑是什麼。

Yes. Sure. Elizabeth, I'll start and then I'll pass it over to Sharon. I think really, there's 2 different sets of proof points in the drug discovery business. The first is with our partnership with Genentech in oncology and cell therapy, what you'll see first is an IND filing on a shared product and then we're making really strong efforts. We haven't yet disclosed the timeline, but I can tell you that we're moving rapidly towards proof-of-concept on the private product.

是的。當然。伊麗莎白，我先開始，然後再交給莎倫。我真的認為，在藥物發現業務中有兩套不同的證據點。首先是我們與 Genentech 在腫瘤學和細胞療法方面的合作，您首先會看到共享產品的 IND 備案，然後我們正在做出非常大的努力。我們還沒有透露時間表，但我可以告訴你，我們正在快速推進私有產品的概念驗證。

And then we have another set of proof points and validation points that we're working hard towards with our internal programs, which I'll pass over to Sharon to better describe.

然後我們有另一組證明點和驗證點，我們正在通過我們的內部程序努力工作，我將把它們傳遞給 Sharon 以更好地描述。

Yes. So for our internal programs, the goal and the focus, first and foremost, in autoimmunity is to get to at least 1 target that's disease specific. We've highlighted our efforts and our focus on investments in multiple sclerosis and IBD. And once we have a target that's validated and that we're confident warrants a therapeutic program, that's where we'll deploy our TCR or antibody capabilities to develop an actual therapeutic asset and advance those with a goal to advance those ourselves into the clinic.

是的。因此，對於我們的內部計劃，自身免疫的目標和重點首先是達到至少一個疾病特異性目標。我們強調了我們在多發性硬化症和 IBD 方面的努力和投資重點。一旦我們有了一個經過驗證的目標並且我們有信心保證一個治療計劃，那就是我們將部署我們的 TCR 或抗體能力來開發實際的治療資產並推進這些資產，目標是將我們自己推進這些資產進入臨床。

And our next question comes from Andrew Brackmann from William Blair.

我們的下一個問題來自 William Blair 的 Andrew Brackmann。

Maybe I just want to follow up on some of the clonoSEQ commentary for the community setting. Chad, I think you just referenced a win on a large account basis. Maybe just qualitatively, can you talk about the tipping point that was there for that win? And maybe some of the other accounts that you're talking to, how is a funnel progressing there?

也許我只是想跟進一些針對社區設置的 clonoSEQ 評論。乍得，我想你只是提到了大客戶的勝利。也許只是定性的，你能談談那場胜利的轉折點嗎？也許您正在與之交談的其他一些客戶，那裡的漏斗進展如何？

Sure. Nitin, I'll have you -- do you want to highlight, without necessarily being specific on the accounts, do you want to highlight what the tipping point was for -- you can pick one of them, one of our large community practice accounts that has recently signed on?

當然。 Nitin，我會請你——你想強調一下，但不一定要具體說明賬戶，你想強調一下引爆點是什麼——你可以選擇其中之一，我們的大型社區實踐賬戶之一最近簽到了嗎？

Yes. I think, first, I'll just broadly speak. What we did this year was higher additional individuals with focus on community accounts. And we took a multipronged approach here. We not only have individuals who do physician education, but we have a strategic account management team that works with large community practices at the C-level. So multiple things came into place.

是的。我想，首先，我只是籠統地說。我們今年所做的是更多的人關注社區賬戶。我們在這裡採取了多管齊下的方法。我們不僅有從事醫生教育的個人，而且還有一個戰略客戶管理團隊，在 C 級與大型社區實踐合作。所以很多事情都到位了。

In one particular account, after engaging with them over several months, they have standardized their clinical workflows on clonoSEQ upon the arrival of every patient that's diagnosed, for example, with CLL. And we expect more of these to happen in 2023 and be a key contributor to growth. And as I said, our community business is trending upwards, and went from 8% at the beginning of 2022 to 15%. And I expect that to become 20% of our business in 2023, while our penetration in academic and institutional accounts also increases.

在一個特定的帳戶中，在與他們接觸了幾個月之後，他們在每一位被診斷出患有 CLL 的患者到達時都在 clonoSEQ 上標準化了他們的臨床工作流程。我們預計 2023 年會發生更多這樣的事情，並成為增長的關鍵因素。正如我所說，我們的社區業務呈上升趨勢，從 2022 年初的 8% 上升到 15%。我預計到 2023 年，這將占我們業務的 20%，同時我們在學術和機構賬戶中的滲透率也會增加。

Okay. And then just a quick one on the macro front here. I think about a month ago, you referenced the Inflation Reduction Act as a potential headwind there. Can you just give us current thoughts on how you're thinking about that and maybe some of the conversations you're having with pharma related to that?

好的。然後這裡只是宏觀方面的一個快速的。我想大約一個月前，你提到了《通貨膨脹減少法案》是那裡的潛在逆風。您能否告訴我們您目前的想法，以及您與製藥公司進行的一些與此相關的對話？

Sure. You could go first, and maybe Sharon can comment from the pharma services business as well.

當然。您可以先發言，也許 Sharon 也可以從製藥服務業務部門發表評論。

Yes. I think we've had many conversations with pharma companies, and we're hearing from many of them that due to IRA, there's increased scrutiny over their budgets. And I think the second thing we're seeing play out is, particularly in multiple myeloma, there's a lot of competition, lots of drug programs are going on out there. The efficacy of the drugs that have recently come out are very high, and pharma companies are looking at which programs to continue with and which programs to sunset. That's the MRD pharma side. I'll pass it to Sharon for Immune Medicine.

是的。我想我們已經與製藥公司進行了多次對話，我們從他們中的許多人那裡得知，由於 IRA，對他們預算的審查越來越嚴格。我認為我們看到的第二件事是，特別是在多發性骨髓瘤中，競爭很激烈，很多藥物項目正在進行中。最近上市的藥物療效非常好，製藥公司正在研究哪些項目要繼續，哪些項目要停止。這是 MRD 製藥方面。我會把它交給免疫醫學的莎倫。

Yes. I think it's mostly a watch and wait, but obviously, that's top of mind. And we, too, will monitor, but no immediate impact as of yet for us.

是的。我認為這主要是觀察和等待，但顯然，這是最重要的。我們也將進行監控，但目前還沒有對我們產生直接影響。

And our next question comes from Sung Ji Nam from Scotiabank.

我們的下一個問題來自豐業銀行的 Sung Ji Nam。

Just a couple of housekeeping questions for Tycho. Sorry if I missed it, but did you -- are you guys including the potential milestone payment from Genentech IND filing in your guidance?

第谷只是幾個內務問題。對不起，如果我錯過了，但是你們有沒有在你們的指南中包括來自 Genentech IND 申請的潛在里程碑付款？

We are. So that's at the end of the year. As I mentioned earlier, we recognize -- so the milestone is on acceptance. That can lag filing by a minimum of 30 days, but it can take longer. And we recognized $7 million of that upfront and then amortize the remaining $3 million. And there's no other Genentech milestone. So we're only recognizing the one in guidance.

我們是。那是在年底。正如我之前提到的，我們認識到 - 所以里程碑是接受。這可能會延遲提交至少 30 天，但也可能需要更長時間。我們確認了其中的 700 萬美元，然後攤銷了剩餘的 300 萬美元。並且沒有其他基因泰克里程碑。所以我們只承認指導中的那個。

Okay. And then would you be able to break out what your assumption is for the interest expense for the year?

好的。然後，您能否詳細說明您對當年利息支出的假設是什麼？

Yes. So the good thing is interest income actually offsets interest expense. So we have about -- I think it's over $30 million now in interest income in the model. So that actually pays for the OrbiMed deal itself.

是的。所以好消息是利息收入實際上抵消了利息支出。所以我們有大約 - 我認為現在模型中的利息收入超過 3000 萬美元。所以這實際上支付了 OrbiMed 交易本身的費用。

And our next question comes from Dan Leonard from Credit Suisse.

我們的下一個問題來自瑞士信貸的 Dan Leonard。

Just a couple of questions on the '23 guide. Tycho, I'm trying to map to that $95 million revenue figure for Immune Medicine in '23. I think you said Genentech amortization is $35 million. So that would mean the balance $60 million is pharma services. Is that -- it looks like that's nearly a double year-on-year from the '22 number? And is that math even correct? And what's driving that? Is there any bookings or book-to-bill or anything you could offer?

關於 '23 指南的幾個問題。第谷，我正試圖映射到免疫醫學在 23 年的 9500 萬美元收入數字。我想你說過 Genentech 的攤銷是 3500 萬美元。所以這意味著餘額 6000 萬美元用於製藥服務。那是——看起來比 22 年的數字幾乎翻了一番？那數學甚至是正確的嗎？是什麼推動了它？是否有任何預訂或預訂到賬單或您可以提供的任何東西？

Yes. So, Dan, I talked earlier about the long-term CAGR for pharma services being in the 20% range. There's other drug discovery, right? So we have various ongoing discussions with potential drug discovery partners that would be the remainder of that. So it's not all at pharma services.

是的。所以，丹，我之前談到了製藥服務的長期復合年增長率在 20% 的範圍內。還有其他藥物發現，對吧？因此，我們與潛在的藥物發現合作夥伴進行了各種持續的討論，這將是剩下的。因此，這不僅僅在於製藥服務。

And the milestones.

以及里程碑。

And the milestone, yes.

里程碑，是的。

And then a question on revenue phasing. I think this was asked a couple different ways, but you highlighted a very strong start to the year in MRD. You're flagging, though, Q1 is a low point. Is there anything to reconcile the timing related besides just the milestones in the second half of the year when thinking about phasing?

然後是關於收入階段的問題。我認為有人以幾種不同的方式提出這個問題，但您強調了 MRD 今年開局非常強勁。不過，你在暗示，Q1 是一個低點。在考慮分階段時，除了下半年的里程碑之外，還有什麼可以調和相關的時間安排嗎？

Yes. So I talked about the Genentech headwind. That's the biggest headwind on the year. In the first quarter alone, it's about a $4.2 million headwind. We did recognize a $3 million MRD pharma milestone last year. So there's a comp from that as well. There's no T-Detect revenue. So those are some of the factors that would impact the first quarter relative to the remainder of the year.

是的。所以我談到了基因泰克的逆風。這是今年最大的逆風。僅在第一季度，就有大約 420 萬美元的逆風。去年我們確實認識到了 300 萬美元的 MRD 製藥里程碑。所以也有一個補償。沒有 T-Detect 收入。因此，這些是影響第一季度相對於今年剩餘時間的一些因素。

And thank you. And I am showing no further questions. This concludes today's conference call. Thank you for participating, and you may now disconnect.

謝謝你。我不再提出更多問題。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。