Exact Sciences Corp (EXAS) 2022 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day, and welcome to the Exact Sciences Second Quarter 2021 Earnings Call. Today's call is being recorded.

    美好的一天,歡迎來到 Exact Sciences 2021 年第二季度財報電話會議。今天的電話正在錄音。

  • I would now like to turn the call over to Megan Jones, Senior Director of Investor Relations. Please go ahead.

    我現在想將電話轉給投資者關係高級總監梅根瓊斯。請繼續。

  • Megan Jones - Associate Manager of IR

    Megan Jones - Associate Manager of IR

  • Thanks for joining us for Exact Sciences' Second Quarter 2022 Conference Call. On the call today are Kevin Conroy, the company's Chairman and CEO; and Jeff Elliott, our Chief Financial Officer and Chief Operating Officer; Everett Cunningham, our Chief Commercial Officer, will also be available for questions.

    感謝您參加 Exact Sciences 的 2022 年第二季度電話會議。今天的電話會議是公司董事長兼首席執行官凱文康羅伊;以及我們的首席財務官兼首席運營官 Jeff Elliott;我們的首席商務官 Everett Cunningham 也將接受提問。

  • Exact Sciences issued a news release earlier this afternoon detailing our second quarter financial results. This news release and today's presentation are available on our website at exactsciences.com.

    Exact Sciences 今天下午早些時候發布了一份新聞稿,詳細介紹了我們第二季度的財務業績。本新聞稿和今天的演示文稿可在我們的網站exactsciences.com 上獲取。

  • During today's call, we will make forward-looking statements based on current expectations. Our actual results may have material differences from such statements. Reconciliations to GAAP figures are available in our earnings press release, and descriptions of the risks and uncertainties associated with Exact Sciences are included in our SEC filings. Both can be accessed through our website.

    在今天的電話會議中,我們將根據當前的預期做出前瞻性陳述。我們的實際結果可能與此類陳述存在重大差異。我們的收益新聞稿中提供了與 GAAP 數據的對賬,與 Exact Sciences 相關的風險和不確定性的描述包含在我們提交給 SEC 的文件中。兩者都可以通過我們的網站訪問。

  • I'll now turn the call over to Kevin.

    我現在把電話轉給凱文。

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Thanks, Megan. During the second quarter, the team made several advancements toward our vision to eradicate cancer through earlier detection and smarter answers for patients and their health care providers. The highlights from the quarter include being a Great Place to Work certified for the fourth consecutive year, screening more than 700,000 people for colon cancer with Cologuard, securing an improved position in ASCO guidelines for Oncotype DX Breast as the preferred test for early-stage breast cancer patients, improving our path to profitability and cash liquidity position.

    謝謝,梅根。在第二季度,該團隊通過為患者及其醫療保健提供者提供更早的檢測和更智能的答案,朝著我們根除癌症的願景取得了一些進展。本季度的亮點包括連續第四年獲得最佳工作場所認證,使用 Cologuard 篩查超過 700,000 人的結腸癌,確保在 ASCO 指南中將 Oncotype DX Breast 作為早期乳房的首選檢測方法的地位提高癌症患者,改善我們的盈利能力和現金流動性狀況。

  • Cutting adjusted EBITDA loss in half quarter-over-quarter, showcasing the breadth of our screening and precision oncology pipeline with 13 abstracts at ASCO. Making progress towards completing BLUE-C, our pivotal study to support our next-generation Cologuard and colon cancer blood test, publishing evidence for our [tumor-naive] minimum residual disease testing colon cancer. Generating additional evidence for our multi-cancer early detection test, which we plan to share at the European Society for Medical Oncology or ESMO conference in September.

    調整後的 EBITDA 虧損環比減少一半,展示了我們在 ASCO 的 13 個摘要的篩查和精準腫瘤學管道的廣度。在完成 BLUE-C 方面取得進展,這是我們支持我們的下一代 Cologuard 和結腸癌血液檢測的關鍵研究,公佈了我們 [tumor-naive] 最小殘留疾病檢測結腸癌的證據。為我們的多癌症早期檢測測試提供更多證據,我們計劃在 9 月的歐洲醫學腫瘤學會或 ESMO 會議上分享。

  • And finally, enhancing our sequencing capabilities by partnering with Ultima Genomics.

    最後,通過與 Ultima Genomics 合作來增強我們的測序能力。

  • We're focused on executing with our core business of Cologuard and Oncotype DX prioritizing the highest-impact projects to reach profitability and generating high-quality evidence for our pipeline of advanced cancer tests.

    我們專注於執行我們的 Cologuard 和 Oncotype DX 核心業務,優先考慮影響最大的項目以實現盈利,並為我們的高級癌症檢測管道提供高質量的證據。

  • Jeff will now review our financial results.

    Jeff 現在將審查我們的財務業績。

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Thanks, Kevin. Good afternoon. Second quarter revenue was $522 million, an increase of 20% or 20 (inaudible) COVID testing. Screening revenue was $354 million, an increase of 34%, including 4 points from PreventionGenetics.

    謝謝,凱文。下午好。第二季度收入為 5.22 億美元,增長 20% 或 20 次(聽不清)COVID 測試。篩查收入為 3.54 億美元,增長 34%,其中來自 PreventionGenetics 的 4 分。

  • Cologuard growth was driven by improved sales team productivity, our marketing partnership with Katie Couric, 3-year rescreens and used in the 45 to 49 age group. 9,000 new health care providers ordered Cologuard during the quarter and nearly 282,000 have ordered since launch.

    Cologuard 的增長得益於銷售團隊生產力的提高、我們與 Katie Couric 的營銷合作夥伴關係、3 年重新篩選並用於 45 至 49 歲年齡段。本季度有 9,000 家新的醫療保健提供者訂購了 Cologuard,自推出以來已訂購近 282,000 家。

  • Precision Oncology revenue was $154 million, an increase of 12%, driven by Oncotype DX Breast and therapy selection. Foreign exchange was a $2 million headwind. COVID testing revenue decreased 58% to $14 million.

    在 Oncotype DX Breast 和治療選擇的推動下,Precision Oncology 的收入為 1.54 億美元,增長了 12%。外匯是 200 萬美元的逆風。 COVID 測試收入下降 58% 至 1400 萬美元。

  • Second quarter GAAP gross margin was 68%. Non-GAAP gross margin, which excludes amortization of acquired intangibles, was 72%. Margins were lower than expected due to inflation, especially shipping and wages. We expect inflation and unfavorable foreign exchange to be about a 2-point headwind in the second half of the year compared to our prior guidance of about 73%.

    第二季度 GAAP 毛利率為 68%。不包括收購的無形資產攤銷的非美國通用會計準則毛利率為 72%。由於通貨膨脹,尤其是航運和工資,利潤率低於預期。我們預計下半年通脹和不利的外匯匯率將比我們之前的指導值約 73% 帶來約 2 個百分點的阻力。

  • We expect margins to expand as we absorb the additional lab capacity brought online for Cologuard and introduce new automation.

    隨著我們吸收為 Cologuard 在線帶來的額外實驗室容量並引入新的自動化,我們預計利潤率將擴大。

  • Sales and marketing expense was $216 million. G&A expense was $182 million, including a $24 million net gain mainly related to Thrive, and a $5 million expense from cost reduction activities.

    銷售和營銷費用為 2.16 億美元。 G&A 費用為 1.82 億美元,包括主要與 Thrive 相關的 2400 萬美元淨收益,以及來自成本削減活動的 500 萬美元費用。

  • R&D expense was $106 million. Net loss was $166 million and adjusted EBITDA with a loss of $46 million. This improved $76 million from 2 quarters ago and $44 million from last quarter.

    研發費用為 1.06 億美元。淨虧損為 1.66 億美元,調整後 EBITDA 虧損 4600 萬美元。這比兩個季度前增加了 7600 萬美元,比上一季度增加了 4400 萬美元。

  • We ended the quarter (inaudible) with $728 million. We established an AR securitization facility during the quarter with up to $150 million in borrowing capacity. For the agreement, we borrowed $50 million under the facility. We also have about $150 million available on our revolving credit facilities. This provides total liquidity of almost $1 billion.

    我們以 7.28 億美元結束了本季度(聽不清)。我們在本季度建立了一個 AR 證券化工具,擁有高達 1.5 億美元的借貸能力。對於該協議,我們在該設施下借了 5000 萬美元。我們的循環信貸額度也有大約 1.5 億美元可用。這提供了近 10 億美元的總流動性。

  • We're also exploring ways to unlock capital from our real estate facilities. We expect our cash used to be lower in the second half of the year compared to the first half, and we're confident in achieving adjusted EBITDA profitability in 2024 while we continue investing in future growth and efficiencies.

    我們還在探索從我們的房地產設施中釋放資金的方法。我們預計下半年我們的現金將低於上半年,我們有信心在 2024 年實現調整後的 EBITDA 盈利能力,同時繼續投資於未來的增長和效率。

  • For example, we're investing $300 million in IT this year to improve our digital tools and support initiatives like Cologuard rescreens, enhance our customer experience and billing systems, and limited redundant costs from legacy IT platforms.

    例如,我們今年將在 IT 方面投資 3 億美元,以改進我們的數字工具和支持 Cologuard 重新篩選等計劃,增強我們的客戶體驗和計費系統,並限制傳統 IT 平台的冗餘成本。

  • Turning to our guidance. We expect total revenue between $490 million and $505 million during the third quarter and between $1.98 billion and $2.022 billion for the year. We expect screening revenue between $350 million and $355 million for the third quarter and between $1.35 billion and $1.372 billion for the year.

    轉向我們的指導。我們預計第三季度總收入在 4.9 億美元至 5.05 億美元之間,全年總收入在 19.8 億美元至 20.22 億美元之間。我們預計第三季度的放映收入在 3.5 億美元至 3.55 億美元之間,全年在 13.5 億美元至 13.72 億美元之間。

  • This includes PreventionGenetics revenue of approximately $10 million during the third quarter and between $40 million and $42 million for the year. We expect Precision Oncology revenue between $135 million and $140 million for the third quarter and between $580 million and $590 million for the year.

    這包括 PreventionGenetics 第三季度約 1000 萬美元的收入和全年 4000 萬美元至 4200 萬美元的收入。我們預計 Precision Oncology 第三季度的收入將在 1.35 億美元至 1.4 億美元之間,今年將在 5.8 億美元至 5.9 億美元之間。

  • Our expectations for global Oncotype DX Breast are unchanged. We're up in our guidance to reflect portfolio -- product portfolio changes and a $4 million incremental FX headwind for the year. We divested our Oncotype DX Genomic Prostate Score test to ensure our team is focused on the highest impact projects and improving our profitability.

    我們對全球 Oncotype DX Breast 的期望沒有改變。我們提高了我們的指導以反映投資組合——產品組合的變化和今年增加的 400 萬美元的外匯逆風。我們剝離了 Oncotype DX 基因組前列腺評分測試,以確保我們的團隊專注於影響最大的項目並提高我們的盈利能力。

  • Certain members of our dedicated urology team will transition to MDxHealth, a commercial-stage precision diagnostics company focused solely on prostate cancer and other urological diseases. We have agreed to provide certain transition services to MDxHealth, including lab services to ensure a smooth transition for patients.

    我們專門的泌尿科團隊的某些成員將過渡到 MDxHealth,這是一家商業階段的精確診斷公司,專注於前列腺癌和其他泌尿科疾病。我們已同意向 MDxHealth 提供某些過渡服務,包括實驗室服務,以確保患者順利過渡。

  • For the agreement, Exact Sciences received $30 million upfront, including $25 million in cash and $5 million in MDxHealth Equity. An additional $70 million is payable to Exact Sciences upon achievement of certain revenue milestones.

    對於該協議,Exact Sciences 獲得了 3000 萬美元的預付款,其中包括 2500 萬美元的現金和 500 萬美元的 MDxHealth Equity。在實現某些收入里程碑後,將向 Exact Sciences 額外支付 7000 萬美元。

  • We expect COVID testing revenue between $5 million and $10 million for the third quarter and between $50 million and $60 million for the year.

    我們預計第三季度 COVID 測試收入在 500 萬美元到 1000 萬美元之間,全年在 5000 萬美元到 6000 萬美元之間。

  • Moving to OpEx for the full year, we are lowering our sales and marketing expense by $30 million and now expect between $870 million and $890 million. In the second quarter, we saw improvement in key sales and marketing metrics, such as revenue per sales representative. We expect this to improve further as we grow Cologuard and make more products available.

    全年轉向運營支出,我們將銷售和營銷費用降低 3000 萬美元,現在預計在 8.7 億美元到 8.9 億美元之間。在第二季度,我們看到關鍵銷售和營銷指標有所改善,例如每位銷售代表的收入。隨著我們發展 Cologuard 並提供更多產品,我們預計這將進一步改善。

  • We're also lowering our research and development expense by $5 million and now expect between $425 million and $445 million. Our expectations for G&A, CapEx and intangible amortization remain the same.

    我們還將研發費用降低了 500 萬美元,現在預計在 4.25 億美元到 4.45 億美元之間。我們對 G&A、資本支出和無形攤銷的預期保持不變。

  • I'll now turn the call back to Kevin.

    我現在將電話轉回給凱文。

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Thanks, Jeff. A recent study showed that about half of Americans between ages 50 and 75 are not up to date with colon cancer screen. That means as many as 60 million Americans need to be screened. Cologuard is helping to solve this problem.

    謝謝,傑夫。最近的一項研究表明,在 50 至 75 歲之間的美國人中,約有一半沒有進行結腸癌篩查。這意味著多達 6000 萬美國人需要接受篩查。 Cologuard 正在幫助解決這個問題。

  • Almost half of first-time Cologuard users are new to screen. The Centers for Medicare and Medicaid Services or CMS recently proposed removing a barrier to getting more people screened by eliminating Medicare cost sharing for a follow-up colonoscopy after a positive stool-based screening test.

    幾乎一半的首次使用 Cologuard 的用戶是新用戶。醫療保險和醫療補助服務中心或 CMS 最近提議通過在糞便篩查檢測呈陽性後取消後續結腸鏡檢查的醫療保險費用分攤,消除讓更多人接受篩查的障礙。

  • This follows a federal regulation requiring private payers to eliminate cost sharing starting in 2023, this addresses a top concerned patients and providers have about using Cologuard. Our sales and marketing teams are helping screen more people with Cologuard by: one, using a multichannel marketing approach to elevate colon cancer screening and Cologuard; two, Investing to support our health system partner's needs; and three, implementing tools to help keep people up to date with screen.

    這遵循了一項聯邦法規,要求私人支付者從 2023 年開始取消成本分攤,這解決了患者和提供者對使用 Cologuard 最關心的問題。我們的銷售和營銷團隊正在通過以下方式幫助更多人篩查 Cologuard: 一、使用多渠道營銷方法提升結腸癌篩查和 Cologuard;二,投資以支持我們的衛生系統合作夥伴的需求;第三,實施工具以幫助人們了解屏幕的最新情況。

  • A powerful data and digital infrastructure is one key to unlocking the full potential of Cologuard, Oncotype DX and our future tests. We have spent nearly a decade thoughtfully designing and enhancing our IT systems, including a custom-built laboratory information system, and installing Epic as the backbone of all processes from ordering to billing. This will power one interface to meet our health system and physician partners testing needs in hereditary cancer, colon cancer, multi-cancer, prognosis, minimum residual disease, and late-stage therapy selection, all of these tests.

    強大的數據和數字基礎設施是釋放 Cologuard、Oncotype DX 和我們未來測試的全部潛力的關鍵之一。我們花了近十年的時間精心設計和增強我們的 IT 系統,包括定制的實驗室信息系統,並將 Epic 安裝為從訂購到計費的所有流程的支柱。這將為一個接口提供動力,以滿足我們的衛生系統和醫生合作夥伴在遺傳性癌症、結腸癌、多發性癌症、預後、最小殘留疾病和晚期治療選擇以及所有這些測試方面的測試需求。

  • Our goal is to make it easy for health care providers to order all advanced cancer tests through one partner, making prevention and diagnosis simple and personalized instead of complicated and fragmented. Exact Sciences has the foundation in Precision Oncology to provide answers to key questions a cancer patient, oncologists, biopharma or academic partner may have.

    我們的目標是讓醫療保健提供者通過一個合作夥伴輕鬆訂購所有晚期癌症檢測,使預防和診斷變得簡單和個性化,而不是複雜和分散。 Exact Sciences 擁有精準腫瘤學的基礎,可以為癌症患者、腫瘤學家、生物製藥或學術合作夥伴可能遇到的關鍵問題提供答案。

  • order all advanced cancer test through one partner, making prevention and diagnosis simple and personalized the set of complicated and fragmented. Exec Sciences has the foundation in precision oncology to provide answers to key questions a cancer patient, oncologists, biopharma or academic (inaudible) we may have.

    通過一個合作夥伴訂購所有晚期癌症測試,使預防和診斷變得簡單,個性化的一套複雜和碎片。 Exec Sciences 擁有精準腫瘤學的基礎,可以為我們可能遇到的癌症患者、腫瘤學家、生物製藥或學術(聽不清)的關鍵問題提供答案。

  • The Oncotype DX Breast test is now the most strongly recommended in ASCO guidelines with the highest evidence quality of all multi-gene tests. To expand our Precision Oncology test offering, we're developing a minimum residual disease test, enhancing our therapy selection test and partnering with biopharma companies to help identify and develop better therapies for patients.

    Oncotype DX Breast 測試現在是 ASCO 指南中最強烈推薦的,在所有多基因測試中具有最高的證據質量。為了擴展我們的精準腫瘤學測試產品,我們正在開發一種最小殘留疾病測試,加強我們的治療選擇測試,並與生物製藥公司合作,以幫助識別和開發更好的患者治療方法。

  • Therapy selection, we're taking aspects from our current tests, oncomap and oncomap ExTra to bring 1 market-leading comprehensive test to patients. PreventionGenetics recently received approval for the first FDA authorized Class II molecular companion diagnostic device developed in collaboration with Rhythm Pharmaceuticals. With 40 biopharma partnerships, the PreventionGenetics team provides invaluable relationships to build upon for future diagnostics.

    治療選擇,我們正在從我們當前的測試、oncomap 和 oncomap ExTra 中獲取方面,為患者帶來 1 個市場領先的綜合測試。 PreventionGenetics 最近獲得了與 Rhythm Pharmaceuticals 合作開發的首個 FDA 授權的 II 類分子伴隨診斷設備的批准。憑藉 40 個生物製藥合作夥伴關係,PreventionGenetics 團隊為未來的診斷提供了寶貴的關係。

  • The team is also planning a focused pilot launch of hereditary cancer testing later this year to help breast cancer patients make better treatment decisions based on the genetic makeup tumor.

    該團隊還計劃在今年晚些時候進行遺傳性癌症檢測的重點試點,以幫助乳腺癌患者根據基因組成腫瘤做出更好的治療決策。

  • In the next 12 months, we plan to deliver evidence supporting 3 of the most important diagnostic advancements for patients, colon cancer screening, multi-cancer early detection, and minimum residual disease testing. We displayed the breadth and depth of our pipeline at ASCO with 13 abstracts. In our prospective BLUE-C trial, which is support of colon cancer screening programs, we're happy to announce that we've enrolled a number of cancers necessary to power and FDA submission for our next-generation Cologuard test.

    在接下來的 12 個月內,我們計劃提供證據支持 3 項最重要的患者診斷進展,即結腸癌篩查、多癌早期檢測和最小殘留疾病檢測。我們用 13 篇摘要展示了我們在 ASCO 管道的廣度和深度。在我們支持結腸癌篩查計劃的前瞻性 BLUE-C 試驗中,我們很高興地宣布,我們已經招募了許多必要的癌症,以便為我們的下一代 Cologuard 測試提供動力和 FDA 提交。

  • We will continue enrollment we have enough cancer cases to support our colon cancer blood test. In multi-cancer early detection, we plan to share data at ASMO in September, constraints the power of our multimarker approach.

    我們將繼續招生,我們有足夠的癌症病例來支持我們的結腸癌血液檢測。在多癌症早期檢測方面,我們計劃在 9 月在 ASMO 共享數據,這限制了我們多標誌物方法的能力。

  • In minimum residual disease, we published evidence supporting our tumor-naive panel in colon cancer at ASCO. We also initiated a study with the [West German] Study Group to validate our tumor-informed approach in breast cancer and expect to have additional data in colon cancer later this year.

    在最小殘留疾病方面,我們在 ASCO 發表了支持我們在結腸癌中的腫瘤初治小組的證據。我們還與 [西德] 研究小組一起啟動了一項研究,以驗證我們在乳腺癌中的腫瘤知情方法,並希望在今年晚些時候獲得更多關於結腸癌的數據。

  • We want to provide patients better information before diagnosis and across all stages of cancer treatment. We have a team with expertise across many technologies and biomarkers. This provides flexibility to deliver the best test on the right place for each question we're answering before and throughout a cancer diagnosis. Our development work with Ultima Genomics and Singular Genomics may provide future access to a differentiated and affordable sequencing technology and another tool to help the best outcome for patients.

    我們希望在診斷前和癌症治療的所有階段為患者提供更好的信息。我們擁有一支擁有多種技術和生物標誌物專業知識的團隊。這提供了靈活性,可以在正確的位置為我們在癌症診斷之前和整個過程中回答的每個問題提供最佳測試。我們與 Ultima Genomics 和 Singular Genomics 的開發工作可能會為未來提供差異化且負擔得起的測序技術和另一種幫助患者獲得最佳結果的工具。

  • We're now happy to take your questions.

    我們現在很高興回答您的問題。

  • Operator

    Operator

  • (Operator Instructions) We'll take our first question from Derik De Bruin with Bank of America..

    (操作員說明)我們將回答美國銀行的 Derik De Bruin 提出的第一個問題。

  • Derik De Bruin - MD of Equity Research

    Derik De Bruin - MD of Equity Research

  • I guess to start off, I mean, there was a $12 million beat on Cologuard relative to consensus and our estimates on the quarter, yet you're still maintaining the full year guide. I guess why the conservatism for the second half of the year, given you should have a number of tailwinds that are sort of there given the sales force and less COVID. And I guess, additional thoughts on how we should think about Cologuard for '23?

    我想一開始,我的意思是,相對於共識和我們對本季度的估計,Cologuard 有 1200 萬美元的節拍,但你仍然保持全年指南。我猜為什麼下半年會出現保守主義,因為考慮到銷售人員和較少的 COVID,你應該有一些順風。我想,關於我們應該如何看待 23 年的 Cologuard 的其他想法?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Well, let me start and then hand that over to Jeff as well. To start by saying we are guiding to 22% growth in the back half of the year. And taking a step back, Cologuard has a tremendously long runway ahead of it. There are between 45 million and 60 million unscreened people who need to be screened, the people 45 to 49 are starting to be screened at an increasing cliff. And the environment for access to physicians has not changed. It has been essentially flat over the first half of the year. We expected that to increase.

    好吧,讓我開始,然後把它也交給傑夫。首先,我們正在指導今年下半年實現 22% 的增長。退後一步,Cologuard 有一條非常長的跑道。有 4500 萬到 6000 萬未接受篩查的人需要接受篩查,45 到 49 歲的人群開始接受篩查,而且數量越來越多。就醫的環境沒有改變。今年上半年基本持平。我們預計會增加。

  • Eventually, it will again. What we're seeing is that we moved from a period where access was limited because of COVID to now access being more limited because of office staff shortages. All of those things are temporary in nature and the need for colon cancer screening is persistent, and we're seeing a fundamental shift that is that Cologuard is becoming more [fully] accepted within large health systems, along primary-care physicians, importantly, among patients as a great way to get screened. It's just becoming more common and the data back that up, Jeff, on some of those aspects of ordering behaviors, but the positive is the upside is tremendous. And we continue to expect to meet or beat our 40% long-term market share goal with Cologuard.

    最終,它會再次出現。我們看到的是,我們從因 COVID 限制訪問權限的時期轉變為現在由於辦公室人員短缺而限制訪問權限的時期。所有這些事情本質上都是暫時的,結腸癌篩查的需求是持久的,我們看到了一個根本性的轉變,即 Cologuard 在大型衛生系統中變得越來越 [完全] 被接受,包括初級保健醫生,重要的是,在患者中作為一種很好的篩查方式。它只是變得越來越普遍,而且數據支持這一點,傑夫,關於訂購行為的某些方面,但積極的是,好處是巨大的。我們繼續期望通過 Cologuard 實現或超過我們 40% 的長期市場份額目標。

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Derik, this is Jeff. As Kevin talked about, we're guiding to 22% growth in the back half of this year for Cologuard. That's $120 million of incremental revenue. I mean keep in mind, Cologuard, as you know, is the $1 billion plus product is profitable today. We're emphasizing profitable growth going forward. I want to make sure what we built here is sustainable and generate consistent growth in cash flow. We'll guide to next year as we could do likely in our fourth quarter call. There was a ton of (inaudible) about Kevin talked about that. He mentioned the efficiency of things they're doing with health systems work at 50% now electronic. That number will continue to climb higher with the backlog of systems that are signing up just really waiting to convert to electronic ordering. I mean you do that, you see the next list in orders.

    德里克,這是傑夫。正如凱文所說,我們預計 Cologuard 在今年下半年實現 22% 的增長。這是 1.2 億美元的增量收入。我的意思是請記住,如您所知,Cologuard 是 10 億美元以上的產品今天是有利可圖的。我們強調未來的盈利增長。我想確保我們在這裡建造的東西是可持續的,並產生持續的現金流增長。我們將指導明年,因為我們可能會在第四季度的電話會議中這樣做。凱文談到了很多(聽不清)。他提到他們在衛生系統中所做的事情的效率現在已經達到電子化的 50%。隨著系統的積壓,這個數字將繼續攀升,這些系統正在等待轉換為電子訂購。我的意思是你這樣做,你會在訂單中看到下一個列表。

  • So I feel good progress have made growth. Today, we have about 3.5 months left in the year, a Cologuard order perspective, recall things really slowed down for us, our ability to turn orders into revenue really goes down after Thanksgiving. So here today about 3.5 months left in the year, we will try to do everything we can, but you should think of the midpoint of guidance for the year as the most likely outcome.

    所以我感覺良好的進步已經取得了增長。今天,我們一年還剩下大約 3.5 個月,從 Cologuard 訂單的角度來看,回想一下我們的速度真的慢了下來,感恩節之後我們將訂單轉化為收入的能力真的下降了。所以今天在這裡,一年還剩下大約 3.5 個月,我們將盡我們所能,但你應該將今年的指導中點視為最有可能的結果。

  • Operator

    Operator

  • We'll take our next question from Brandon Couillard with Jefferies.

    我們將向 Jefferies 的 Brandon Couillard 提出下一個問題。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Two-part question for Jeff. First, (inaudible) reduction in sales and marketing (inaudible) on the driver of that? And then on G&A, I think there was a $25 million gain in the second quarter. But your spending outlook unchanged. Is that right?

    傑夫的兩部分問題。首先,(聽不清)銷售和營銷(聽不清)減少的驅動因素是什麼?然後在 G&A 上,我認為第二季度有 2500 萬美元的收益。但你的消費前景不變。那正確嗎?

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Yes. It's a two-part question, Brandon. The first one, I'll start and maybe Kevin can chime in too, if he's got something to add.

    是的。這是一個兩部分的問題,布蘭登。第一個,我會開始,如果凱文有什麼要補充的,也許凱文也可以加入。

  • So I think what you're seeing here an emphasis on prioritization and invested in the highest return areas of growth. So Everett and team has very nice job making sure we're targeting the right doctors targeting the right territory. Always looking at marketing spend closely.

    所以我認為你在這裡看到的重點是優先考慮並投資於回報率最高的增長領域。因此,埃弗雷特和團隊非常出色地確保了我們針對正確的領域的正確醫生。始終密切關注營銷支出。

  • So what I'm really pleased to see the improvement that we saw when you look at the sequentials here, sequential growth of 7%, a sequential decline in sales and marketing of 7%. So this is some really nice efficiencies we're getting.

    所以我真的很高興看到我們看到的改善,當你看到這裡的連續增長,連續增長 7%,銷售和營銷連續下降 7%。所以這是我們得到的一些非常好的效率。

  • I mentioned in my remarks, we're seeing improved efficiency of our sales team. This was part of the plan that we kicked off earlier this year to improve the productivity there. (inaudible) on this (inaudible) we had this (inaudible) the last 2 quarters, a (inaudible) $5 million gain.

    我在講話中提到,我們看到銷售團隊的效率有所提高。這是我們今年早些時候啟動的計劃的一部分,旨在提高那裡的生產力。 (聽不清)在這個(聽不清)上,我們在過去兩個季度有這個(聽不清),(聽不清)500 萬美元的收益。

  • Really, this relates to the earn for the transition. The only thing that really happens as interest rates go up, the math around the accretion on that says that we've got to take a gain. So that's really the dynamic care. That could happen again in the future. I'm not counting, but it could happen again as interest rates fluctuate. So that's the change there.

    實際上,這與過渡的收入有關。隨著利率上升,唯一真正發生的事情是,圍繞增長的數學表明我們必須獲得收益。所以這才是真正的動態護理。將來可能會再次發生這種情況。我不算數,但隨著利率的波動,它可能會再次發生。這就是那裡的變化。

  • As far as the G&A in the back half, we're continuing to invest in things like IT. So that's likely the step up in the back half. IT is a crucial driver for the efficiencies that we expect (inaudible) the time. So I think those investments make to add on the sales and marketing line.

    至於後半部分的 G&A,我們將繼續投資於 IT 等領域。所以這很可能是後半部分的進步。 IT 是我們預期(聽不清)時間效率的關鍵驅動因素。所以我認為這些投資可以增加銷售和營銷線。

  • Everett Cunningham

    Everett Cunningham

  • Jeff, just (inaudible) a (inaudible) optimal deployment. We've taken a look at putting our resources toward those largest opportunities that we have. I like and (inaudible) about where we've invested in our commercial organization. We've invested in our health systems organization. We know that health systems have been and will be more important as we (inaudible) the year goes as we go into 2024. That health systems allowed us to really develop a deep partnership, making sure that Cologuard a major choice for those large systems.

    傑夫,只是(聽不清)一個(聽不清)最佳部署。我們已經考慮將我們的資源用於我們擁有的那些最大的機會。我喜歡並且(聽不清)我們在哪裡投資了我們的商業組織。我們已經投資於我們的衛生系統組織。我們知道,隨著我們(聽不清)進入 2024 年,衛生系統已經並將變得更加重要。衛生系統使我們能夠真正建立深厚的合作夥伴關係,確保 Cologuard 成為這些大型系統的主要選擇。

  • Operator

    Operator

  • We'll take our next question from Brian Weinstein from William Blair.

    我們將向威廉布萊爾的布萊恩溫斯坦提出下一個問題。

  • Brian David Weinstein - Partner, Group Head of Life Sciences & Healthcare Analyst

    Brian David Weinstein - Partner, Group Head of Life Sciences & Healthcare Analyst

  • Not really thrilled that you brought up [3.5 million] giving [5] and Sunny in Chicago to the -- I don't want to think about that yet. So not cool at all. So you guys divested an asset this quarter clearly what makes maybe ever, if you talk about the portfolio broadly, any thoughts on the right time to potentially add to the bag to maximize kind of sales to more broadly and even [potentially] Cologuard, like even in Precision Oncology an [acquirer]. Should we expect that to continue? Reason I'm asking is obviously just content, but also -- just wondering how M&A or other types of opportunities to add to help Cologuard potentially how that factors into kind of comments you've made in the past about not raising equity, of course, and then also in profitability. So kind of a bunch of stuff bundled up there. Hopefully, that makes sense.

    你提出 [350 萬] 給 [5] 和芝加哥的 Sunny 給他們,這並不是很激動——我還不想考慮這個問題。所以一點都不酷。所以你們本季度剝離了一項資產,如果你廣泛地談論投資組合,任何關於合適的時間可能會增加袋子以最大限度地擴大銷售到更廣泛甚至[潛在地] Cologuard 的想法,比如即使在精準腫瘤學中也是一個[收購者]。我們應該期望這種情況繼續下去嗎?我要問的原因顯然只是內容,但也只是想知道併購或其他類型的機會如何增加以幫助 Cologuard 可能如何影響你過去關於不籌集股權的評論,當然,然後也是盈利能力。一堆東西捆綁在那裡。希望這是有道理的。

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Yes. Thanks, Brian. This is Kevin. The -- if you go look back to 2016, I think we generated $99 million of revenue and this year, we're guiding to $2 billion. So the company has been transformed an important part of that transformation was joining (inaudible) genomic and building what we believe is the best reach from -- all the way from primary care, GI, OB/GYN, other specialties all the way to oncology.

    是的。謝謝,布賴恩。這是凱文。 - 如果你回顧 2016 年,我認為我們創造了 9900 萬美元的收入,而今年,我們的目標是 20 億美元。因此,公司已經轉型,轉型的一個重要部分是加入(聽不清)基因組,並建立我們認為的最佳覆蓋範圍——從初級保健、胃腸道、婦產科、其他專業一直到腫瘤學.

  • So if you then look at what is our portfolio strategy, you have, we think, the best brands in cancer testing, Cologuard and Oncotype DX Breast which are anchored to our long-term growth. And now looking at our pipeline, we have multiple early detection testing.

    因此,如果您再看看我們的投資組合戰略是什麼,我們認為您擁有癌症檢測領域的最佳品牌 Cologuard 和 Oncotype DX Breast,它們與我們的長期增長息息相關。現在看看我們的管道,我們有多個早期檢測測試。

  • Really an amazing opportunity to access 135 million Americans on a regular basis and transform cancer care by making detection earlier.

    定期接觸 1.35 億美國人並通過更早地進行檢測來改變癌症護理,這確實是一個絕佳的機會。

  • Two, our colon cancer next-generation test in colon cancer blood programs, the minimum residual disease. Those 3 group products access a total combined TAM of about [$60 billion]. And we are the company that can deliver (inaudible) one of the reasons we can deliver it is because we have this amazing IT platform that is suited from (inaudible) earns about a test, they order it, they get a result all the way to billing.

    二、我們的結腸癌新一代檢測結腸癌血液程序,殘留病灶最小。這 3 組產品的總 TAM 約為 [600 億美元]。我們是可以交付(聽不清)的公司,我們可以交付它的原因之一是因為我們擁有這個令人驚嘆的 IT 平台,它適合(聽不清)關於測試的收入,他們訂購它,他們一路得到結果到帳單。

  • The investment there is huge. We believe the best commercial organization, not only in cancer diagnostics, but in Diagnostics, this is an incredible team of professionals that engages, deep capabilities in clinical and regulatory. This allows us to take new products and drop them in to this portfolio.

    那裡的投資是巨大的。我們相信最好的商業組織,不僅在癌症診斷方面,而且在診斷方面,這是一個令人難以置信的專業團隊,在臨床和監管方面擁有深厚的能力。這使我們能夠採用新產品並將它們放入該產品組合中。

  • And so our M&A philosophy is driven by will the product or technology to contribute to this long-term strategy that I just articulated. Is it the right culture of it and does it create shareholder value.

    因此,我們的併購理念是由產品或技術驅動的,以便為我剛剛闡述的這個長期戰略做出貢獻。它的文化是否正確,是否創造了股東價值。

  • When it comes to our Oncotype DX Prostate test, it's a great test. I know people personally who have benefited greatly from the information that test delivers. And MDxHealth is -- we know the leadership of the company well. It's a very strong company totally focused on urology.

    當談到我們的 Oncotype DX 前列腺測試時,這是一個很好的測試。我個人認識一些從測試提供的信息中受益匪淺的人。 MDxHealth 是——我們非常了解公司的領導層。這是一家非常強大的公司,完全專注於泌尿外科。

  • We will be one of the important shareholders of the company. We want to support and help them be successful and we believe that this is the right home for Oncotype DX Prostate. So we'll continue.

    我們將成為公司的重要股東之一。我們希望支持並幫助他們取得成功,我們相信這是 Oncotype DX Prostate 的正確歸宿。所以我們會繼續。

  • Everett, I don't know if you have anything to add there.

    埃弗雷特,我不知道你有什麼要補充的。

  • Everett Cunningham

    Everett Cunningham

  • Yes. Kevin, I will just add one thing. I've been out in the field over the last 1.5 months, talking to large health systems about this portfolio approach to our cancer continuum and the response that they -- that the health systems are giving us, the CEOs, the CMOs, they're saying, if you can simplify the number of lab partners that we had to deal with, and you have the back-end support of all your IT solutions to help our workflow. They're going to partner with us. We're going to move from selling individual products to being their cancer continuum partner that's what health systems are looking for. That's what we've seen over the last -- that's what I've seen over the last 1.5 months that I've been in the field. So it's inspiring.

    是的。凱文,我只會補充一件事。在過去的 1.5 個月裡,我一直在這個領域,與大型衛生系統討論這種針對我們的癌症連續性的組合方法以及他們的反應——衛生系統給我們、首席執行官、首席營銷官、他們的反應重新說,如果您可以簡化我們必須處理的實驗室合作夥伴的數量,並且您擁有所有 IT 解決方案的後端支持來幫助我們的工作流程。他們將與我們合作。我們將從銷售單個產品轉變為成為他們的癌症連續合作夥伴,這正是衛生系統正在尋找的。這就是我們在過去看到的——這就是我在過去 1.5 個月裡看到的。所以很鼓舞人心。

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Thanks, Everett.

    謝謝,埃弗里特。

  • Operator

    Operator

  • We'll take our next question from Catherine Schulte with Baird.

    我們將向凱瑟琳舒爾特和貝爾德提出下一個問題。

  • Catherine Walden Ramsey Schulte - Senior Research Analyst

    Catherine Walden Ramsey Schulte - Senior Research Analyst

  • Yes. First, in the past, you've talked about the group of docs that had represented the top 40% of orders pre-COVID still down, while the bottom group is ordering much more than they did pre-pandemic. Did that trend continue in the second quarter? And how long do you think it takes for that top tier of orders to come back?

    是的。首先,在過去,您曾談到在 COVID 之前代表前 40% 訂單的文檔組仍然下降,而底部組的訂單量比大流行前要多得多。這種趨勢在第二季度是否繼續?您認為頂級訂單需要多長時間才能回來?

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Catherine, this is Jeff. This is a really exciting part of the business. Something I know Kevin and I never look at closely and we're really sort of the future shares.

    凱瑟琳,這是傑夫。這是業務中非常令人興奮的部分。我認識凱文,我從不仔細觀察,我們真的是未來的股票。

  • So that trend, it actually accelerated in the quarter relative to prior quarters. So we saw those doctors that order -- historically had ordered most recently. They improved their orders now are down just under 10% relative to the start of the pandemic. Again, that's an environment of more limited access. That was -- that compares to about down 15% in the first quarter.

    因此,相對於前幾個季度,這一趨勢實際上在本季度加速。所以我們看到那些訂購的醫生 - 歷史上最近訂購的。與大流行開始時相比,他們現在的訂單減少了不到 10%。同樣,這是一個訪問受限的環境。那是 - 相比之下,第一季度下降了約 15%。

  • So again, improvement sequentially. These are doctors that are the true believers. They order still at a higher rate, the patient flow is ticking back up and as excess improves, they will come back even more and expand from their current levels.

    再次,依次改進。這些醫生是真正的信徒。他們仍然以更高的速度訂購,患者流量正在回升,並且隨著過剩的改善,他們會更多地回來並從目前的水平擴大。

  • The doctors who historically only doubled, ordered infrequently, oftentimes, we didn't even call them. This part of the business tremendously exciting. Those doctors have essentially doubled their order rate relative to the start of the pandemic. It continues to improve. Last quarter, I think it was up 60%, now it's closer to 100% improvement since the start of the pandemic.

    歷史上只加倍,很少訂購的醫生,通常,我們甚至沒有給他們打電話。這部分業務非常令人興奮。相對於大流行的開始,這些醫生的訂單率基本上翻了一番。它繼續改進。上個季度,我認為它上漲了 60%,現在自大流行開始以來已經接近 100% 的改善。

  • So this provides a huge growth opportunity for us for years to come. We can selectively call the most promising doctors in this group we're seeing this broadening of the order base. That really bodes well now for Cologuard, also other products like hereditary cancer and multi-cancer as we launch them, we'll have a broader base of physicians to launch them through.

    因此,這為我們未來幾年提供了巨大的增長機會。我們可以有選擇地打電話給這個群體中最有前途的醫生,因為我們看到了訂單基礎的擴大。對於 Cologuard 來說,這確實是個好兆頭,還有其他產品,如遺傳性癌症和多發性癌症,當我們推出它們時,我們將擁有更廣泛的醫生基礎來推出它們。

  • Operator

    Operator

  • We'll take our next question from Dan Brennan with Cowen.

    我們將與 Cowen 一起回答 Dan Brennan 的下一個問題。

  • Daniel Gregory Brennan - Research Analyst

    Daniel Gregory Brennan - Research Analyst

  • Great. Thanks, guys. Thanks for the question. Kevin, I thought I'd just ask you about with ECLIPSE coming. Obviously, you've spoken pretty prominently on expectations, but net-net, by the time we get to the next call, the data could be out. Just wondering if you can update us anything incremental in kind of how you're thinking about the different scenarios and kind of how exact will react depending upon the scenario and kind of how Cologuard will be positioned versus scenarios?

    偉大的。多謝你們。謝謝你的問題。凱文,我想我會問你關於 ECLIPSE 即將到來的事情。顯然,您已經非常突出地表達了期望,但是 net-net,當我們進行下一次通話時,數據可能已經出來了。只是想知道您是否可以向我們更新任何增量信息,例如您對不同場景的思考方式,以及根據場景和 Cologuard 將如何定位與場景的具體反應方式?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Well, let me remind you the -- there are many challenges in bringing a blood -- colon cancer blood test, to market as a leading way to screen people for cancer. There are 5 main reasons. Number one is that any of the blood tests, the data that we've seen are less accurate than Cologuard and colonoscopy and other established screening approaches.

    好吧,讓我提醒你 - 帶來血液 - 結腸癌血液測試存在許多挑戰,作為篩查人們癌症的主要方式上市。有5個主要原因。第一是任何血液測試,我們看到的數據不如 Cologuard 和結腸鏡檢查以及其他已建立的篩查方法準確。

  • Equivalent FDA approval and claim language is unlikely. And that's a challenge when it comes to introducing a new test into the off-way challenging and complicated screening paradigm. The bar for guideline inclusion, which drives commercial coverage is very high. Pricing is likely to be sub-$200.

    等效的 FDA 批准和聲明語言不太可能。在將新測試引入到具有挑戰性和復雜性的篩查範式中時,這是一個挑戰。推動商業覆蓋的指南納入標準非常高。定價可能低於 200 美元。

  • And -- then there's the question of where does the blood test fit given that you have tremendous performance in terms of efficacy with colonoscopy and Cologuard, so I think the market is challenged. Our view hasn't changed here. We have a blood test that we expect to be priced appropriately. We have a commercial team, a lab infrastructure and IT system where we will be able to drop our blood test into that ecosystem, making it really easy for docs to order and patients to use a test if for any reason they opt not to get a Cologuard test.

    並且 - 鑑於您在結腸鏡檢查和 Cologuard 的功效方面具有出色的表現,因此存在的問題是血液測試適合哪裡,所以我認為市場受到挑戰。我們的觀點在這裡沒有改變。我們有一項血液測試,我們希望它的價格合理。我們有一個商業團隊、一個實驗室基礎設施和 IT 系統,我們將能夠將我們的血液測試投入到該生態系統中,如果出於任何原因他們選擇不接受血液測試,那麼醫生可以很容易地訂購和患者使用測試Cologuard 測試。

  • And so that's our view of this in terms of data. Data is step 1. There's FDA approval. There's getting claim language, Medicare coverage, et cetera. that will take -- most likely will take multiple years. USPSTF's next output is probably 3 to 4 years away.

    這就是我們對數據的看法。數據是第一步。有 FDA 批准。有索賠語言、醫療保險覆蓋範圍等。這將需要 - 很可能需要數年時間。 USPSTF 的下一個輸出可能是 3 到 4 年後。

  • Operator

    Operator

  • Our next question comes from Vijay Kumar with Evercore ISI.

    我們的下一個問題來自 Evercore ISI 的 Vijay Kumar。

  • Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team

    Vijay Muniyappa Kumar - Senior MD and Head of Medical Supplies & Devices and Life Science Tools & Diagnostics Team

  • Congrats on the (inaudible). I had one on this path to profitability. Jeff, it looks like your gross margin assumptions changed. I heard some comments on inflation. What's your updated free cash flow burn rate for the year? And when you think about the 2024 adjusted EBITDA pack of profitability, assuming revenues to grow teens gross margins are consistent. I mean, your OpEx has to grow low singles over the next 2 years. Are those assumptions reasonable? Did that make sense for you, given we're looking at an exact being at the high end of your peer group growth set?

    恭喜(聽不清)。我在這條盈利之路上有一個。傑夫,看起來你的毛利率假設發生了變化。我聽到了一些關於通貨膨脹的評論。您今年更新的自由現金流消耗率是多少?當您考慮 2024 年調整後的 EBITDA 盈利能力包時,假設收入增長青少年毛利率是一致的。我的意思是,你的 OpEx 必須在接下來的 2 年內增長到低單價。這些假設合理嗎?這對你有意義嗎,因為我們正在尋找一個確切的存在於你的同儕群體增長集的高端?

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Thanks, Vijay. This is Jeff. And I just want to say it again. I know we've said this before, but we are firmly committed to adjusted EBITDA profitability for the full year of '24. And we made great progress towards this team pulled together came up with just awesome new ideas on how to get more and more efficient as we grow.

    謝謝,維杰。這是傑夫。我只想再說一遍。我知道我們之前已經說過,但我們堅定地致力於調整 24 年全年的 EBITDA 盈利能力。我們在這個團隊團結起來方面取得了很大進展,提出了關於如何隨著我們的成長而變得越來越高效的很棒的新想法。

  • And going forward, it will start with revenue growth, and Everett and the team are doing a nice raging the top line. I do expect some gross margin improvement over that period. Inflation here in the near term is what I pointed to, should be in wage inflation or incremental headwind relative to our last update where we have significant lab automation projects in flight now that will help us drive improvement on top of the -- leveraging that the fixed cost of our labs.

    展望未來,它將從收入增長開始,埃弗雷特和團隊在收入方面做得很好。我確實預計在此期間毛利率會有所改善。我指出,短期內的通貨膨脹應該是工資上漲或相對於我們上次更新的逆風增加,我們現在有重要的實驗室自動化項目正在進行中,這將幫助我們推動改進——利用我們實驗室的固定成本。

  • So I do expect some gross margin improvement -- and then you're seeing the OpEx discipline. It's starting with the sales and marketing line, look at even more of that of G&A in the coming years. So I feel very good about the path here is going forward.

    所以我確實預計毛利率會有所提高——然後你會看到運營支出紀律。它從銷售和營銷線開始,在未來幾年裡更多地關注 G&A。所以我對這裡前進的道路感覺非常好。

  • Operator

    Operator

  • We'll take our next question from Dan Arias with Stifel.

    我們將與 Stifel 一起回答 Dan Arias 的下一個問題。

  • Daniel Anthony Arias - MD & Senior Analyst

    Daniel Anthony Arias - MD & Senior Analyst

  • Kevin, maybe a couple on the pipeline. Starting with Cologuard 2.0, is the 2023 commercial launch for that assay in the picture at all just given the current submission time line expectations? And then maybe on MRD and the dual approach that you have there? I mean, obviously, there's a need for data generation. It sounds like there's some data on the way. So how are you thinking about the time lines that those tests are on? Should they more or less arrive together? Or is the development path is not something that's going to allow that to happen?

    凱文,也許有一對正在籌備中。從 Cologuard 2.0 開始,考慮到當前的提交時間線預期,圖片中該檢測的 2023 年商業發布是否完全符合預期?然後也許是關於 MRD 和你在那裡的雙重方法?我的意思是,顯然,需要生成數據。聽起來好像有一些數據在路上。那麼,您如何看待這些測試的時間線?他們應該或多或少一起到達嗎?還是開發路徑不會允許這種情況發生?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Cologuard 2.0 or what we call next-generation Cologuard will -- 2023 is a possibility. We have not yet made a determination internally as to when that test will be launched, it will obviously depend upon the test performance. And then there are a whole bunch of things you need to do to make that flow.

    Cologuard 2.0 或我們所說的下一代 Cologuard 將——2023 年是一種可能性。我們尚未在內部確定何時啟動該測試,這顯然取決於測試性能。然後你需要做很多事情來讓這種流動。

  • So we may or may not need a new CPT code that will affect the launch timing and the Medicare coverage and insurance coverage. You want to make sure all of that is locked. So when you flip the switch, you have a very smooth billing process and patient experience process.

    因此,我們可能需要也可能不需要新的 CPT 代碼,它會影響啟動時間以及醫療保險範圍和保險範圍。您要確保所有這些都已鎖定。因此,當您撥動開關時,您將擁有非常順暢的計費流程和患者體驗流程。

  • In terms of MRD, we are -- have a couple -- we have access to a couple of important sample sets that will allow us to seek an LDT status and then work towards getting inclusion as one of the reimbursed tests. We see this space is developing very nicely, it's setting us up for a product launch in MRD, not this year on a reimbursed basis, most likely next year.

    在 MRD 方面,我們 - 有幾個 - 我們可以訪問幾個重要的樣本集,這將使我們能夠尋求 LDT 狀態,然後努力將其納入報銷測試之一。我們看到這個領域發展得非常好,它為我們在 MRD 中推出產品做好了準備,而不是今年在報銷的基礎上,很可能是明年。

  • Operator

    Operator

  • We'll take our next question from Matt Sykes with Goldman Sachs.

    我們將向高盛的 Matt Sykes 提出下一個問題。

  • David Graves Delahunt - Associate

    David Graves Delahunt - Associate

  • This is Dave on for Matt. Congrats on the strong print. Could you tell us -- I hate to ask about physician office access for the millions of time in the past 2 years. But any comments on the percent of pre-pandemic office access, your sales reps are getting in-person and any directionality there?

    這是馬特的戴夫。祝賀強大的印刷品。你能告訴我們——我不想問在過去 2 年里數百萬次訪問醫生辦公室的情況。但是,對大流行前辦公室訪問的百分比、您的銷售代表正在親自接觸以及那裡的任何方向性有何評論?

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • This is Jeff. I'll take that one. Look, we've talked about access being relatively unchanged since our last call, one of the newer dynamics, and this isn't just I'm sure you've heard the companies talk about this -- is a critical staffing shortage that you're seeing in the health care provider setting. So that has the effect of kind of limited access further.

    這是傑夫。我會拿那個。看,自上次通話以來,我們已經談到訪問權限相對沒有變化,這是新動態之一,這不僅僅是我確定你已經聽到公司談論這個 - 是你嚴重的人員短缺'在醫療保健提供者的環境中看到。因此,這具有進一步限制訪問的效果。

  • So I would say where is it relative to pre-pandemic you're probably somewhere at 50%, 60% of pre-pandemic levels. That's what we talked about on our last call. Everett and the team are keen really creative and finding ways around that and making sure that we are a good partner to health systems and other providers, and that's what's helped us deliver upon that growth, including 22% growth in the second half of the year.

    所以我想說,與大流行前相比,你可能處於大流行前水平的 50%、60% 的某個地方。這就是我們上次通話時談到的。埃弗雷特和他的團隊非常熱衷於創造並尋找解決方法,並確保我們是衛生系統和其他提供者的良好合作夥伴,這就是幫助我們實現這一增長的原因,包括今年下半年 22% 的增長.

  • Operator

    Operator

  • We'll take our next question from Patrick Donnelly with Citi.

    我們將向花旗銀行的帕特里克·唐納利提出下一個問題。

  • Patrick Bernard Donnelly - Senior Analyst

    Patrick Bernard Donnelly - Senior Analyst

  • Jeff, maybe following up on that one there. In terms of kind of the improvement in the second half. I think the Cologuard guidance is basically implying kind of flat to down sequentially from what you did in 2Q, Typically, 3Q seasonality is a little bit better. Obviously, a few factors kind of working your way as you've talked about in terms of building the momentum. Is that just conservatism baked into that 3Q number you discussed? Just trying to figure out the moving pieces why that number with 3Q would be better than 2Q sequentially on Cologuard specifically?

    傑夫,也許在那裡跟進那個。在下半年的改善方面。我認為 Cologuard 的指導基本上意味著從你在 2 季度所做的事情開始按順序下降,通常情況下,3 季度的季節性要好一些。顯然,正如您在建立勢頭方面所談到的那樣,有一些因素會以您的方式發揮作用。你討論的那個 3Q 數字只是保守主義嗎?只是想弄清楚為什麼在 Cologuard 上,3Q 的數字會比 2Q 更好?

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Yes, Patrick, this is Jeff. I would just say the guidance is the likely view of where we'll end the year based on everything we've seen. [Access] is part of that. there's other trends out there, too, but I stick to the guidance that likely (inaudible) lands.

    是的,帕特里克,這是傑夫。我只想說,指導是根據我們所看到的一切,我們可能會在哪裡結束這一年。 [訪問] 是其中的一部分。還有其他趨勢,但我堅持可能(聽不清)登陸的指導。

  • Historically, if you look back at the last couple of calls, I talked about the seasonal trends of Cologuard as the base of this business continues to grow, you're going to see that the seasonal pattern shifts a little bit. I think that's what a lot of the Street has missed.

    從歷史上看,如果你回顧最後幾次電話會議,我談到了 Cologuard 的季節性趨勢,因為該業務的基礎繼續增長,你會看到季節性模式發生了一些變化。我認為這就是華爾街很多人所錯過的。

  • So I think it's between that and just Access historically, in prior quarters, we had assumed Access would have improved gradually over the course of this year. Now we're saying it's likely to be flat over the balance of this year. We're just guiding to what we see right now. Maybe it improves, maybe it doesn't, but we're baking in no change to Access for the rest of the year.

    因此,我認為它介於歷史和 Access 之間,在之前的幾個季度,我們曾假設 Access 在今年的過程中會逐漸改善。現在我們說它可能在今年的餘額中持平。我們只是引導我們現在所看到的。也許它有所改善,也許它沒有,但我們在今年餘下的時間裡不會改變 Access。

  • Operator

    Operator

  • We'll take our next question from Jack Meehan with Nephron Research.

    我們將向 Nephron Research 的 Jack Meehan 提出下一個問題。

  • Jack Meehan - Research Analyst

    Jack Meehan - Research Analyst

  • Thank you. Good afternoon. So Kevin, one of your -- or maybe [Forever] as well, one of your competitors launched a colorectal cancer liquid biopsy test is an LVT back in May. So obviously, very super early days, but I was wondering if you saw any impact at certain accounts and what you may or may not be seeing about the interplay between Cologuard and liquid biopsy in the field?

    謝謝你。下午好。所以凱文,你的一個 - 或者可能是 [永遠],你的一個競爭對手在 5 月份推出了一項結直腸癌液體活檢測試是 LVT。很明顯,非常早期,但我想知道您是否看到某些帳戶有任何影響,以及您可能會或可能不會看到 Cologuard 與現場液體活檢之間的相互作用?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • We saw zero impact from any other aspiring entrants into colon cancer screening, during the quarter. We're unlikely to see any impact because tests that aren't reimbursed, that aren't in guidelines that don't count towards a quality measure credit, just don't, it's challenging to conceive of a way that there would be significant uptake there that could impact that we screened over 700,000 people in the quarter. We expect that to continue to grow throughout the next several years and beyond.

    在本季度,我們看到任何其他有抱負的進入結腸癌篩查的參與者的影響為零。我們不太可能看到任何影響,因為沒有報銷的測試,不在不計入質量測量信用的指導方針中,只是不要,想出一種具有重大意義的方法是具有挑戰性的那裡的吸收可能會影響我們在本季度篩查了超過 700,000 人。我們預計這將在未來幾年及以後繼續增長。

  • So no. Really, again, blood tests have a role in colon cancer screening if they achieve at least the same level of cancer sensitivity as a FIT test. And better advanced adenoma pre-cancer detection than we have seen from case control studies. And if so, and there is widespread reimbursement and validation of these tests, we think that they will have a role just not in the near term.

    所以不行。確實,如果血液測試至少達到與 FIT 測試相同的癌症敏感性水平,那麼血液測試在結腸癌篩查中發揮作用。並且比我們從病例對照研究中看到的更先進的腺瘤癌前檢測。如果是這樣,並且這些測試得到了廣泛的報銷和驗證,我們認為它們將在短期內發揮作用。

  • Operator

    Operator

  • We'll take our next question from Mark Massaro with BTIG.

    我們將向 BTIG 的 Mark Massaro 提出下一個問題。

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

    Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • Maybe a two-parter. Jeff, the first one is for you on Oncotype Prostate, you lowered the guidance by $15 million to $20 million for the year. I just wanted to confirm that the rough [GPS] revenue run rate was around $30 million to $40 million?

    也許是二人組。傑夫,第一個是給你的 Oncotype Prostate,你將當年的指導降低了 1500 萬美元至 2000 萬美元。我只是想確認 [GPS] 的粗略收入運行率在 3000 萬到 4000 萬美元之間?

  • And then secondly, I wanted to follow up on the profitability topic. Clearly, you have significant investment to come in multi-cancer early detection significant investment in MRD. And I understand that you divested Oncotype Prostate, small part of your business. But I guess I could use some help as to how you expect to achieve adjusted EBITDA profitability in 2024 when you have the investments that I laid out. And so I guess what I want to maybe clarify is, are you -- do you expect to continue investing in DTC because obviously, that's a pretty significant line item? And then I'd also be -- since you're divesting the prostate sales force, any comments on your GI sales force?

    其次,我想跟進盈利能力的話題。顯然,您在 MRD 的多癌早期檢測方面有重大投資。我知道您剝離了 Oncotype Prostate,這是您業務的一小部分。但我想我可以為您提供一些幫助,以了解當您擁有我列出的投資時,您如何期望在 2024 年實現調整後的 EBITDA 盈利能力。所以我想我想澄清的是,你是否希望繼續投資 DTC,因為很明顯,這是一個非常重要的項目?然後我也想——既然你正在剝離前列腺銷售隊伍,對你的 GI 銷售隊伍有什麼意見嗎?

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • Sure, Mark, this is Jeff. On the first one, I think you're in the right ballpark there. We say that they don't break that up, but you're in the right range.

    當然,馬克,這是傑夫。在第一個方面,我認為你在正確的球場上。我們說他們不會打破它,但你在正確的範圍內。

  • On the second one, look, I mean, we are -- again, we are very committed to being profitable in 2024. Our mantra internally is to keep savings, so we can invest in the highest impact priorities and keep growing this business and serving more patients. And I'm confident we can invest in those 3 key things. Kevin touched on that. Obviously, our colon cancer business, it's MRD in multi-cancer.

    關於第二個,看,我的意思是,我們再次致力於在 2024 年實現盈利。我們內部的口號是保持儲蓄,因此我們可以投資於影響最大的優先事項,並繼續發展這項業務和服務更多的患者。我相信我們可以投資於這三件關鍵的事情。凱文談到了這一點。顯然,我們的結腸癌業務,它是多癌症的 MRD。

  • We benefit from having a strong foundation from which to grow. We've got this foundation of lab, IT, sales force so that we don't have to invest incrementally as we bring these new products to market. The incremental profitability gets even better. So I'm confident. I'm happy to spend some time offline on the math. But I look forward to driving continued leverage of our sales and marketing team and the G&A going forward. I think G&A will be a bigger improvement in the coming years.

    我們受益於擁有堅實的發展基礎。我們擁有實驗室、IT 和銷售團隊的基礎,因此當我們將這些新產品推向市場時,我們不必進行增量投資。增量盈利能力變得更好。所以我很有信心。我很高興在數學上花一些時間離線。但我期待繼續推動我們的銷售和營銷團隊以及 G&A 向前發展。我認為 G&A 在未來幾年會有更大的進步。

  • And then on DTC, yes. We will continue to invest in that. We'll continue to make these investments because the return is very good. The GI sales team is a crucial part of the business going forward, today for Cologuard in the future for a whole series of other products.

    然後在 DTC 上,是的。我們將繼續對此進行投資。我們將繼續進行這些投資,因為回報非常好。 GI 銷售團隊是未來業務的重要組成部分,今天對於 Cologuard 未來的整個系列的其他產品。

  • Operator

    Operator

  • We'll take our next question from Puneet Souda with SVB Securities.

    我們將向 SVB 證券的 Puneet Souda 提出下一個問題。

  • Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

    Puneet Souda - Senior MD of Life Science Tools and Diagnostics & Senior Research Analyst

  • Kevin, Jeff. Two simple ones for me. First one on CMS coverage of diagnostic colonoscopy. I'm wondering if there is any change in the marketing approach among the sales force as a result of this for full coverage of follow-on colonoscopy?

    凱文,傑夫。對我來說兩個簡單的。第一個關於診斷性結腸鏡檢查的 CMS 覆蓋範圍。我想知道銷售人員的營銷方式是否會因此而改變,以全面覆蓋後續結腸鏡檢查?

  • And can you remind us how wide is the coverage of follow-on colonoscopy by commercial payers?

    您能否提醒我們商業支付者對後續結腸鏡檢查的覆蓋範圍有多大?

  • And then just one for Jeff on PreventionGenetics. We have seen a disruption from one1 of the competitors in the marketplace. I heard Heritage Diagnostic peer is reducing their workforce by third. So just wondering in terms of share-taking perspective and opportunity to gain talent?

    然後是傑夫關於預防遺傳學的一個。我們已經看到市場上的一個競爭對手造成了破壞。我聽說傳統診斷同行正在將他們的勞動力減少三分之一。所以只是想知道分享觀點和獲得人才的機會嗎?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • So for CMS coverage, for diagnostic colonoscopies. That's pretty uniform today. And the proposed CMS rule is a change that says when a patient has a positive stool test, so either a FIT test or a Cologuard test, a follow-on colonoscopy should be deemed a screening colonoscopy because it completes that patient's screening journey.

    因此,對於 CMS 覆蓋範圍,對於診斷性結腸鏡檢查。今天很統一啊提議的 CMS 規則是一項更改,說明當患者的糞便檢測呈陽性時,無論是 FIT 檢測還是 Cologuard 檢測,後續結腸鏡檢查都應被視為篩查結腸鏡檢查,因為它完成了患者的篩查過程。

  • And as such, there should be no cost sharing. Today, there is about a 20% cost share or that -- this rule is finalized won't go into effect until next year.

    因此,不應該有成本分攤。今天,大約有 20% 的成本分攤——這個規則最終確定要到明年才會生效。

  • So no, today, we're not out marketing this, but in the future, we will.

    所以,不,今天,我們不會進行營銷,但在未來,我們會。

  • Jeffrey T. Elliott - Executive VP, CFO & COO

    Jeffrey T. Elliott - Executive VP, CFO & COO

  • And just to add some color to that one. You asked on the commercial side of that. So the CMS, the CMS uptake goes follows the Department of Labor regulation that applies to commercial plans. So this is essentially Universal starting in January that diagnostic colonoscopy will be without any constating to the patient. So big wins, something we've advocated for a long time.

    只是為那個添加一些顏色。你問的是商業方面的問題。因此,CMS,CMS 的採用遵循適用於商業計劃的勞工部規定。因此,從 1 月份開始,這基本上是普遍的,診斷性結腸鏡檢查將不會對患者造成任何影響。如此大的勝利,這是我們長期以來一直倡導的。

  • On your second question on PreventionGenetics, we're really pleased with the growth in the quarter and the amount of opportunities that lie ahead. We highlighted the biopharma partnerships there. So couldn't be happier with this new acquisition and all the capabilities there. So it does serve as the foundation for future entrants into hereditary cancer testing.

    關於您關於預防遺傳學的第二個問題,我們對本季度的增長和未來機會的數量感到非常滿意。我們強調了那裡的生物製藥合作夥伴關係。因此,對這次新收購和那裡的所有功能感到非常滿意。因此,它確實可以作為未來進入遺傳性癌症檢測的基礎。

  • The longer-term goal is to really grow the pie especially in the primary care channel. Obviously, we've got a strong foundation there with Cologuard today and future products over time. We do plan a kind of an early access type launch later this year in oncology. I think this is a perfect opportunity for us to build upon the relationships we've established over the past 15-plus years with the Oncotype DX Breast test.

    長期目標是真正做大蛋糕,尤其是在初級保健渠道。顯然,我們在 Cologuard 今天和未來的產品方面已經打下了堅實的基礎。我們確實計劃在今年晚些時候在腫瘤學領域推出一種早期訪問類型的產品。我認為這是我們在過去 15 多年中通過 Oncotype DX 乳房測試建立的關係的絕佳機會。

  • So really pleased about the future opportunity here. I think it's primarily about growing the pie, getting more women, men and women access to this innovative technology.

    對這裡的未來機會感到非常高興。我認為這主要是為了做大蛋糕,讓更多的女性、男性和女性接觸到這項創新技術。

  • Operator

    Operator

  • We'll take our next question from Kyle Mikson with Canaccord.

    我們將向 Canaccord 的 Kyle Mikson 提出我們的下一個問題。

  • Kyle Alexander Mikson - Analyst

    Kyle Alexander Mikson - Analyst

  • I just want to talk about BLUE-C. So you enrolled enough Cologuard to put out patients to power the update submission. I think that was expected but you're going to continue to enroll for the blood arm. I guess how long will that take? And then just maybe remind us of the path forward there and any time lines for the (inaudible)?

    我只想談談BLUE-C。因此,您註冊了足夠多的 Cologuard 來讓患者為更新提交提供動力。我認為這是意料之中的,但您將繼續報名參加血液部門。我猜這需要多長時間?然後也許只是提醒我們那裡的前進道路以及(聽不清)的任何時間線?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • Yes. And it's not -- this is Kevin. This is -- it's not a separate blood arm. Unfortunately, about 10% to 20% of people who are willing to get a stool test, don't complete a blood draw. That's probably because that requires a special trip to a blood collection center or because they don't like needles.

    是的。不是——這是凱文。這是——它不是一個單獨的血臂。不幸的是,大約 10% 到 20% 願意接受糞便檢查的人沒有完成抽血。這可能是因為這需要特別前往採血中心,或者因為他們不喜歡針頭。

  • And so that's why we continue the entire study as we have more patients in the study, it just increases the powering of the study, which is great. That's probably for a few more months. We haven't determined when we will finally lock the study. We're just thrilled that we are in a position that if we wanted to shut down the study for Cologuard -- next-generation Cologuard. We could do that today. We're ultimately excited about the opportunities that both tests afford to patients.

    這就是為什麼我們繼續整個研究的原因,因為我們有更多的患者參與研究,它只會增加研究的動力,這很棒。那可能還要幾個月。我們尚未確定何時最終鎖定研究。如果我們想關閉對 Cologuard 的研究——下一代 Cologuard,我們只是很高興我們處於這樣的位置。我們今天可以做到這一點。我們最終對這兩種測試為患者提供的機會感到興奮。

  • Operator

    Operator

  • We'll take our next question from Alex Nowak with Craig-Hallum Capital Group.

    我們將回答來自 Craig-Hallum Capital Group 的 Alex Nowak 的下一個問題。

  • Alexander David Nowak - Senior Research Analyst

    Alexander David Nowak - Senior Research Analyst

  • Going back to the portfolio strategy. One of the things that Exact Sciences doesn't have is what I'd call bread-and-butter old-school cancer typing like fish flow, pathology, cytogenetics. Do you need to own a broader testing menus to succeed with that portfolio strategy? Or do you eventually see those relatively commodity-like task getting ultimately phased out here replaced with neuro modalities that exact would have?

    回到投資組合策略。 Exact Sciences 所沒有的東西之一就是我所說的像魚流、病理學、細胞遺傳學這樣的老派癌症分型。您是否需要擁有更廣泛的測試菜單才能成功實施該投資組合策略?或者你最終會看到那些相對商品化的任務最終在這裡被淘汰,取而代之的是確切的神經模式?

  • Kevin T. Conroy - Chairman of The Board & CEO

    Kevin T. Conroy - Chairman of The Board & CEO

  • We don't think that those tests will be replaced by molecular tests, rather molecular tests are answering new and different questions that those tissue tests don't always answer. And do we need a flow business or a fish business to be successful. The answer is no.

    我們認為這些測試不會被分子測試取代,相反,分子測試正在回答新的和不同的問題,而這些組織測試並不總是能回答這些問題。我們是否需要流量業務或魚類業務才能成功。答案是不。

  • We don't need that business to be successful over time. We've kind of laid out what our strategic plan is. We're excited about that strategic plan, and we're going to execute that plan like our lives depend upon it because it's the right thing to do for patients.

    我們不需要該業務隨著時間的推移而成功。我們已經制定了我們的戰略計劃。我們對該戰略計劃感到興奮,我們將執行該計劃,就像我們的生活依賴它一樣,因為這對患者來說是正確的事情。

  • Operator

    Operator

  • Thank you. And this does conclude today's presentation. Thank you for your participation. You may now disconnect.

    謝謝你。這確實結束了今天的演示。感謝您的參與。您現在可以斷開連接。