Exact Sciences Corp (EXAS) 2022 Q4 法說會逐字稿

Good morning. My name is Rob, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Exact Sciences Fourth Quarter 2022 Earnings Conference Call. (Operator Instructions)

早上好。我叫 Rob，今天我將擔任你們的會議接線員。此時，我想歡迎大家參加 Exact Sciences 2022 年第四季度收益電話會議。 （操作員說明）

Megan Jones, Senior Director, Investor Relations. You may begin your conference.

梅根·瓊斯，投資者關係高級總監。你可以開始你的會議。

Thanks, Rob. Thank you for joining us for Exact Sciences Fourth 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.

謝謝，羅布。感謝您加入我們參加 Exact Sciences 2022 年第四季度電話會議。今天參加電話會議的有公司董事長兼首席執行官凱文·康羅伊 (Kevin Conroy)；和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 也將回答問題。

Exact Sciences issued a news release earlier this afternoon detailing our fourth 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，詳細介紹了我們第四季度的財務業績。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. Discussions of non-GAAP figures and 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非 GAAP 數據的討論和與 GAAP 數據的調節，我們的 SEC 文件中包含了與 Exact Sciences 相關的風險和不確定性的描述。兩者都可以通過我們的網站訪問。

I'll now turn the call over to Kevin.

我現在將電話轉給凱文。

The strength of our foundation supporting the best brands in cancer diagnostics puts us in a leading position to continue delivering innovative cancer tests, consistent revenue growth and profitability. We are using this platform to help prevent cancer, detect it earlier and guide treatment for more patients globally. Achievements in 2022 that helped strengthen our leadership include surpassing 12 million cumulative people tested for cancer, including 10 million with Cologuard, expanding our global network of ordering health care professionals to more than 350,000, growing core revenue of $380 million year-over-year, becoming adjusted EBITDA profitable in the fourth quarter, completing enrollment of BLUE-C, our pivotal study to support our next-generation Cologuard and colon cancer blood tests, and generating evidence for our multi-cancer early detection and molecular residual disease tests.

我們支持癌症診斷領域最佳品牌的基礎實力使我們處於領先地位，可以繼續提供創新的癌症測試、持續的收入增長和盈利能力。我們正在使用這個平台來幫助預防癌症、及早發現癌症並指導全球更多患者的治療。 2022 年的成就有助於加強我們的領導地位，包括累計接受癌症檢測的人數超過 1200 萬人，其中 1000 萬人使用 Cologuard，將我們訂購醫療保健專業人員的全球網絡擴大到 350,000 多人，核心收入同比增長 3.8 億美元，調整後的 EBITDA 在第四季度實現盈利，完成 BLUE-C 的註冊，這是我們支持我們的下一代 Cologuard 和結腸癌血液測試的關鍵研究，並為我們的多癌症早期檢測和分子殘留疾病測試提供證據。

Over the past decade, we've built a high-quality platform to deliver advanced cancer tests at scale. We've invested heavily in our people, lab infrastructure, technology systems, clinical evidence, brands and customer experience. This platform is fueling the efficient growth for our current tests and over time, it will fuel the next wave of novel cancer diagnostics.

在過去的十年裡，我們建立了一個高質量的平台來大規模提供先進的癌症測試。我們在人員、實驗室基礎設施、技術系統、臨床證據、品牌和客戶體驗方面投入了大量資金。該平台正在推動我們當前測試的有效增長，隨著時間的推移，它將推動下一波新型癌症診斷浪潮。

Our health system customers employ most U.S. health care professionals and seek to improve the quality of care while reducing costs. They are incentivized to focus on preventive care, including cancer screenings. Today, many faces staff shortages, leading to a trend of more in-home services such as Cologuard.

我們的醫療系統客戶僱用了大多數美國醫療保健專業人員，並尋求在降低成本的同時提高醫療質量。他們被鼓勵專注於預防保健，包括癌症篩查。如今，許多人面臨人手短缺，導致出現更多上門服務的趨勢，例如 Cologuard。

Advanced cancer testing -- in advanced cancer testing, health systems continue to ask for fewer partners to meet their needs. A complete range of high-quality, impactful tests, broad insurance coverage, EMR integration and data-sharing capabilities. Exact Sciences is uniquely positioned to deliver on these needs because we have the broadest offering of innovative cancer tests, patient-focused services, EMR integration capabilities and payer relationships.

先進的癌症檢測——在先進的癌症檢測中，衛生系統繼續要求更少的合作夥伴來滿足他們的需求。一整套高質量、有影響力的測試、廣泛的保險範圍、EMR 集成和數據共享功能。 Exact Sciences 在滿足這些需求方面具有獨特的優勢，因為我們擁有最廣泛的創新癌症測試、以患者為中心的服務、EMR 集成能力和付款人關係。

This year, we'll increase adoption of Cologuard and Oncotype DX, create an even better customer experience and advance our key pipeline programs in colorectal cancer, multi-cancer early detection and molecular residual disease. Jeff will now discuss our financial results and outlook for 2023.

今年，我們將增加 Cologuard 和 Oncotype DX 的採用，創造更好的客戶體驗，並推進我們在結直腸癌、多癌症早期檢測和分子殘留疾病方面的關鍵管線項目。 Jeff 現在將討論我們 2023 年的財務業績和展望。

Thanks, Kevin. Good afternoon. Fourth quarter revenue of $553 million grew 17% or 28% excluding COVID testing. Screening revenue of $404 million increased 45%, including 3 points of growth from PreventionGenetics. For the year, screening revenue increased 30% organically. During the quarter, 10,000 new health care professionals ordered Cologuard, bringing the total to more than 302,000 since launch. Precision Oncology revenue decreased 4% to $143 million, excluding the sale of our prostate business and a $2 million FX headwind growth of 1%.

謝謝，凱文。下午好。第四季度收入為 5.53 億美元，增長 17% 或 28%（不包括 COVID 測試）。 4.04 億美元的篩查收入增長了 45%，其中包括來自 PreventionGenetics 的 3 個增長點。全年放映收入有機增長 30%。本季度，有 10,000 名新醫療保健專業人員訂購了 Cologuard，自推出以來總數已超過 302,000 人。 Precision Oncology 收入下降 4% 至 1.43 億美元，其中不包括我們前列腺業務的出售和 200 萬美元的外匯逆風增長 1%。

COVID testing revenue decreased 87% to $6 million. Fourth quarter GAAP gross margin was 70%. Non-GAAP gross margin, excluding the amortization of acquired intangibles was 73%. Net loss was $128 million. Adjusted EBITDA was $5 million, an improvement of $120 million, demonstrating the power of the Exact Sciences platform.

COVID 測試收入下降 87% 至 600 萬美元。第四季度 GAAP 毛利率為 70%。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 73%。淨虧損為 1.28 億美元。調整後的 EBITDA 為 500 萬美元，增加了 1.2 億美元，展示了 Exact Sciences 平台的強大功能。

We ended the year with cash and securities of about $630 million. Our total liquidity is about $840 million, included available credit facilities.

年底，我們擁有約 6.3 億美元的現金和證券。我們的總流動資金約為 8.4 億美元，包括可用信貸額度。

Turning to guidance. We expect total revenue between $536 million and $551 million during the first quarter and $2.265 billion and $2.315 billion for the year. This assumes screening revenue between $390 million and $400 million for the first quarter and $1.66 billion to $1.69 billion for the year. Precision Oncology revenue between $143 million and $148 million for the first quarter and $600 million to $620 million for the year and COVID revenue of $3 million for the first quarter and $5 million for the year.

轉向指導。我們預計第一季度總收入在 5.36 億美元至 5.51 億美元之間，全年總收入為 22.65 億美元至 23.15 億美元。假設第一季度放映收入在 3.9 億美元至 4 億美元之間，全年放映收入在 16.6 億美元至 16.9 億美元之間。 Precision Oncology 第一季度收入在 1.43 億美元至 1.48 億美元之間，全年收入在 6 億至 6.2 億美元之間，COVID 收入在第一季度為 300 萬美元，全年收入為 500 萬美元。

For the year, this implies 18% growth for screening, 5% growth for Precision Oncology, excluding the sale of our prostate business and 14% overall growth, excluding COVID testing and the prostate sale.

今年，這意味著篩查增長 18%，精準腫瘤學增長 5%，不包括我們前列腺業務的銷售和整體增長 14%，不包括 COVID 測試和前列腺銷售。

We exited last year with broad momentum, which has driven a strong first quarter. This is especially through our screening business, where we're seeing the benefits of past investments and great execution from our team. We expect to generate up to $25 million of adjusted EBITDA for the year. This assumes non-GAAP gross margin of about 73% for the year. Our industry-leading gross margins are powering positive adjusted EBITDA and a clear path to free cash flow as we continue investing in growth and efficiencies.

我們去年以廣泛的勢頭退出，這推動了第一季度的強勁增長。這尤其是通過我們的篩選業務，我們看到了過去投資的好處和我們團隊的出色執行力。我們預計今年將產生高達 2500 萬美元的調整後 EBITDA。這是假設本年度非美國通用會計準則毛利率約為 73%。隨著我們繼續投資於增長和效率，我們行業領先的毛利率正在推動積極的調整後 EBITDA 和通往自由現金流的明確途徑。

We expect total GAAP OpEx to increase mid-single digits for the year. This includes an absolute decrease in sales and marketing, offset by increased G&A and R&D. Last year, G&A was reduced by $57 million, primarily from a noncash gain related to the Thrive acquisition earn-out. In addition to cycling against that in this year, we expect $19 million in noncash expense as we accrue for the earn-out payments.

我們預計今年的 GAAP 運營支出總額將增長中個位數。這包括銷售和營銷的絕對減少，但被 G&A 和 R&D 的增加所抵消。去年，G&A 減少了 5700 萬美元，主要來自與 Thrive 收購相關的非現金收益。除了今年的循環外，我們還預計 1900 萬美元的非現金支出是我們為賺取收益而產生的。

R&D is increasing this quarter multi-cancer, MRD programs. And we expect CapEx this year to be about $120 million.

本季度研發正在增加多癌症、MRD 項目。我們預計今年的資本支出約為 1.2 億美元。

I'll now turn the call back to Kevin.

我現在將電話轉回凱文。

Thanks, Jeff. Cologuard is becoming the preferred colorectal cancer screening choice. During the fourth quarter, nearly 160,000 health care professionals ordered Cologuard, a new record, and the rate of people we screen at an all-time high. We are starting 2023 with tailwinds, including stronger health care professional conviction in Cologuard as our frontline screening test, increased consumer awareness, improved electronic ordering and an enhanced digital patient experience.

謝謝，傑夫。 Cologuard 正在成為首選的結直腸癌篩查選擇。第四季度，近 160,000 名醫療保健專業人員訂購了 Cologuard，創下新紀錄，我們篩查的人數也創歷史新高。我們從 2023 年開始順風順水，包括對 Cologuard 作為我們的一線篩查測試的更強大的醫療保健專業信念、更高的消費者意識、改進的電子訂購和增強的數字患者體驗。

Also reached 0.5 million people screened with Cologuard between ages 45 and 49. As of the fourth quarter, we estimate Cologuard grew to 9% penetration of the more than 90 million people ages 50 to 85 in the colon cancer screening market. For the nearly 20 million 45- to 49-year olds, penetration grew to more than 8%. Just 18 months after it was included of that age group was included in USPSTF guidelines.

年齡在 45 至 49 歲之間的 50 萬人接受了 Cologuard 篩查。截至第四季度，我們估計 Cologuard 在結腸癌篩查市場中 50 至 85 歲的 9000 萬人口中的滲透率增長至 9%。對於近 2000 萬 45 至 49 歲的人群，滲透率增長到 8% 以上。在該年齡組被納入 USPSTF 指南後僅 18 個月。

Screening people in the mid- to late 40s will provide recurring revenue for decades as we work to keep them screening every 3 years until they're 85. Cologuard growth is supported by the most powerful sales and marketing team in cancer diagnostic. We engage with health care professionals more than 1 million times each year and have more than doubled the revenue generated per interaction in the past year.

對 40 多歲中後期的人進行篩查將提供數十年的經常性收入，因為我們努力讓他們每 3 年進行一次篩查，直到他們 85 歲。Cologuard 的增長得到了癌症診斷領域最強大的銷售和營銷團隊的支持。我們每年與醫療保健專業人員互動超過 100 萬次，並且在過去一年中每次互動產生的收入增加了一倍以上。

We build brand recognition and loyalty by generating more than 15 billion impressions annually. Our commercial team, supported by rigorous analytics, will get even more efficient over time and help decrease sales and marketing costs as a percent of revenue while supporting growth. Our Precision Oncology team has guided treatment physicians for more than 1.75 million cancer patients around the world, including a record 220,000 people last year.

我們通過每年產生超過 150 億次印象來建立品牌認知度和忠誠度。我們的商業團隊在嚴格分析的支持下，將隨著時間的推移變得更加高效，並有助於降低銷售和營銷成本佔收入的百分比，同時支持增長。我們的精準腫瘤學團隊已經指導了全球超過 175 萬癌症患者的治療醫師，其中包括去年創紀錄的 220,000 人。

Oncotype DX will revolutionize breast cancer care. It is internationally recognized as standard of care for patients with early-stage HR-positive HER2-negative breast cancer, which represents about half of breast cancer cases. We have an opportunity to impact even more lives by making Oncotype DX easily accessible to more women globally, offering OncoExTra, our enhanced therapy selection test with DNA and RNA analysis and working with our biopharma partners to develop new targeted cancer therapeutics.

Oncotype DX 將徹底改變乳腺癌治療。它是國際公認的早期 HR 陽性 HER2 陰性乳腺癌患者的護理標準，約佔乳腺癌病例的一半。我們有機會通過讓全球更多女性輕鬆使用 Oncotype DX 來影響更多的生活，提供 OncoExTra，我們通過 DNA 和 RNA 分析增強的治療選擇測試，並與我們的生物製藥合作夥伴合作開發新的靶向癌症療法。

Thanks to our team, trusted Oncotype DX brand and deep oncology relationships, we can power better treatment decisions that are specific to each patient's disease. Our advanced R&D expertise and platform screening and Precision Oncology will help get our pipeline test to more patients quickly. We made meaningful progress in each of our key pipeline programs last year by completing the enrollment of our BLUE-C pivotal trial, which included more than 26,000 people. Presenting 2 studies, including 4,200 samples showing the power of our multi-cancer early detection test and initiating and enrolling studies that will answer key questions clinicians and payers have when evaluating our molecular residual disease tests. We are completing the final steps of our BLUE-C trial and expect to have top line next-generation Cologuard data mid-2023 before submitting to the FDA for approval.

得益於我們的團隊、值得信賴的 Oncotype DX 品牌和深厚的腫瘤學關係，我們可以針對每位患者的疾病做出更好的治療決策。我們先進的研發專業知識和平台篩選以及精準腫瘤學將有助於讓我們的管道測試更快地惠及更多患者。去年，我們完成了 BLUE-C 關鍵試驗的註冊，其中包括超過 26,000 人，我們在每個關鍵管道項目中都取得了有意義的進展。展示 2 項研究，包括 4,200 個樣本，顯示我們的多癌症早期檢測測試的能力，並啟動和招募研究，這些研究將回答臨床醫生和付款人在評估我們的分子殘留疾病測試時遇到的關鍵問題。我們正在完成 BLUE-C 試驗的最後步驟，預計在提交給 FDA 批准之前，將在 2023 年年中獲得頂級的下一代 Cologuard 數據。

We expect to have 2 additional sets of multi-cancer early detection data this year, further validating our multi-market class approach before we move to a larger prospective trial. We also plan to validate and make our tumor-informed molecular residual disease test available to colon cancer patients later this year.

我們預計今年會有 2 組額外的多癌症早期檢測數據，在我們進行更大規模的前瞻性試驗之前進一步驗證我們的多市場類別方法。我們還計劃在今年晚些時候驗證並向結腸癌患者提供我們的腫瘤信息分子殘留疾病測試。

Our mission is to make an earlier detection a routine part of medical care to help eradicate cancer. Our platform, deeply embedded standard of care test and pipeline of life-changing diagnostics will power years of growth and continued profitability, helping us to achieve our mission. Thank you.

我們的使命是使早期檢測成為醫療保健的常規部分，以幫助根除癌症。我們的平台、深入嵌入的護理測試標準和改變生活的診斷管道將為多年的增長和持續盈利提供動力，幫助我們實現使命。謝謝。

We're happy to open the line for questions.

我們很樂意打開問題熱線。

(Operator Instructions) Your first question comes from the line of Derik De Bruin from Bank of America.

（操作員說明）您的第一個問題來自美國銀行的 Derik De Bruin。

It's Derik. So can you just -- so a couple of points, a couple of questions. I think the first one is, I guess, what were the key market changes that drove some of the increased momentum in Q4? And the guide was better than expected, particularly for Cologuard for 2023. And that's one.

是德里克。那麼你能不能 - 所以有幾點，幾個問題。我認為第一個是推動第四季度增長勢頭的關鍵市場變化是什麼？該指南比預期的要好，特別是對於 2023 年的 Cologuard。僅此而已。

And then just -- I've gotten a bunch of questions from investors lately about the competitive landscape outside of liquid biopsy. There's a couple of companies that are advancing some of their stool-based colon cancer screening test and also just sort of the landscape for Oncotype as it sort of goes OUS, there's a little bit more competitive opportunities out there. Can you just sort of talk through the couple of questions?

然後——我最近從投資者那裡收到了很多關於液體活檢以外的競爭格局的問題。有幾家公司正在推進他們的一些基於糞便的結腸癌篩查測試，也只是 Oncotype 的前景，因為它有點像 OUS，那裡有更多的競爭機會。你能談談這幾個問題嗎？

Let's first address the momentum that we saw throughout the fourth quarter and the start of the year. A lot of this is just the result of the investments that we have made over time. The strong need for noninvasive screening -- colon cancer screening tool.

讓我們首先談談我們在整個第四季度和今年年初看到的勢頭。其中很多只是我們隨著時間的推移所做的投資的結果。強烈需要無創篩查——結腸癌篩查工具。

So you have some structural tailwinds, including the ease of electronic ordering that has taken a significant amount of effort, time engagement with large health systems to deliver electronic ordering through our Epic and EMR capabilities, increased brand awareness around Cologuard, health systems are highly incented to drive their colon cancer screening scores, and they're frequently now reaching out to us to ask for a partner who can help them improve their quality measures, care gaps, et cetera.

所以你有一些結構性的順風，包括電子訂購的便利性需要大量的努力，與大型衛生系統的時間接觸以通過我們的 Epic 和 EMR 功能提供電子訂購，圍繞 Cologuard 的品牌知名度提高，衛生系統受到高度激勵為了提高他們的結腸癌篩查分數，他們現在經常聯繫我們，尋求可以幫助他們改善質量措施、護理差距等方面的合作夥伴。

We're seeing GIs have a staff shortage and there's a greater focus in the endoscopy suite on diagnostic colonoscopies, and GIs are ordering our Cologuard at a higher rate as primary care physicians are certainly. Our sales and marketing team, I just can't tell you how proud we are of the work that they have done and continue to do, be it their efficiency, their engagement is turning the tide and really making Cologuard our first-line screening choice.

我們看到 GI 人員短缺，內窺鏡檢查套件更加關注診斷性結腸鏡檢查，並且 GI 正在以更高的速度訂購我們的 Cologuard，因為初級保健醫生肯定是這樣。我們的銷售和營銷團隊，我無法告訴你我們對他們已經完成和繼續做的工作感到多麼自豪，無論是他們的效率，他們的參與正在扭轉局勢，真正使 Cologuard 成為我們的一線篩選選擇.

Also, of course, the 45- to 49-year-old age group. 18 months ago, the guidelines changed to lower from age 50 to 45. And we believe Cologuard is leading in terms of market share today, and the penetration is impressive. If you take the fourth quarter number of tests and extrapolate that, we believe we're -- the penetration is about 8% as I mentioned. Jeff, I don't know if you want to add any color to that.

當然，還有 45 至 49 歲的年齡組。 18 個月前，指南將年齡從 50 歲降至 45 歲。我們相信 Cologuard 在當今的市場份額方面處於領先地位，而且滲透率令人印象深刻。如果你進行第四季度的測試並進行推斷，我們相信我們 - 正如我提到的那樣，滲透率約為 8%。傑夫，我不知道你是否想為此添加任何顏色。

Just to add to what Kevin said, electronic order just a huge, huge year last year. Recall, when we started the pandemic back in early '20, 30% of Cologuard orders were electronic. In Q4, that was up to 63%. So that has implications not only for Cologuard. You make it easier to get orders. It has implications down the road. As we launch new products, we'll launch right into that foundation. So overall, a deeper connection to health systems.

補充一下凱文所說的，電子訂單去年是一個非常非常大的一年。回想一下，當我們在 20 世紀初開始大流行時，30% 的 Cologuard 訂單都是電子訂單。在第四季度，這一比例高達 63%。因此，這不僅對 Cologuard 有影響。您可以更輕鬆地獲得訂單。它對未來有影響。當我們推出新產品時，我們將直接進入該基礎。總的來說，與衛生系統的聯繫更深。

In Q4, I think as we talked before, Derik, we picked up a little bit of extra upside from enhancements we made pulled to our patient compliance engine and our billing systems. So again, these added to the upside, they weren't the sole cause of it.

在第四季度，我認為正如我們之前所說的那樣，Derik，我們從我們對患者合規引擎和計費系統所做的改進中獲得了一些額外的好處。因此，再一次，這些增加了好處，但它們並不是唯一的原因。

The reason I bring those up is because when we added these enhancements, which will benefit on a run rate basis, we'll get better compliance and better -- kind of better ASPs going forward. On the end of those enhancements, we typically pulled forward a bit of revenue from Q2 to Q3. So consider that catch-up revenue that added a little bit more in Q4. So you really can't take Q4 to extrapolate that.

我提出這些的原因是因為當我們添加這些增強功能時，這將在運行率的基礎上受益，我們將獲得更好的合規性和更好的 - 更好的 ASP 前進。在這些改進結束時，我們通常會把一些收入從第二季度提前到第三季度。因此，請考慮在第四季度增加一點的追趕收入。所以你真的不能用第四季度來推斷這一點。

Now I've got half of Q1 in the books now. I think a little bit of that catch-up revenue, again, from the billing enhancements patient compliance enhancements is [spilling] into Q1. That's part of the strength in Q1. And then as everything Kevin said, should continue. I know there's questions on competition.

現在我已經知道了 Q1 的一半。我認為，來自患者依從性增強的計費增強的追趕收入中有一點 [溢出] 到第一季度。這是第一季度實力的一部分。然後正如凱文所說的那樣，應該繼續。我知道有關於競爭的問題。

Yes. In terms of competitive dynamics, when you look at Cologuard, Cologuard set a standard of care at a very high bar in colon cancer screening. Cologuard 2.0 or what we call the next-generation Cologuard will raise that bar. And we just haven't seen data indicating any other testing modality that approaches that high level of performance for detecting cancer or detecting precancerous polyps and having a high specificity rate. And you have to be careful when you take a look at data, is it apples-to-apples, what are the underlying drivers, how large is the study, how well powered, et cetera, et cetera. So we feel great about the competitive positioning. There's so much more to Cologuard than the test. There's enormous investment altogether, about $1 billion invested in an IT infrastructure, a commercial team, a lab team and capability that is -- requires a multibillion-dollar investment to be able to reach the hundreds of thousands of ordering health care providers and the tens of millions of patients.

是的。在競爭動態方面，當您查看 Cologuard 時，Cologuard 在結腸癌篩查中設定了非常高的護理標準。 Cologuard 2.0 或我們所說的下一代 Cologuard 將提高這一標準。而且我們只是還沒有看到數據表明任何其他測試方式可以接近檢測癌症或檢測癌前息肉的高水平性能並具有高特異性率。當你查看數據時，你必須小心，它是同類產品，潛在的驅動因素是什麼，研究的規模有多大，動力有多大，等等。所以我們對競爭定位感覺很好。 Cologuard 的功能遠不止測試。總共有巨大的投資，大約 10 億美元投資於 IT 基礎設施、商業團隊、實驗室團隊和能力——需要數十億美元的投資才能覆蓋數十萬訂購的醫療保健提供者和數十名數百萬患者。

Oncotype DX is in a class of its own. It's the only test with the level of evidence that you've seen with TAILORx and RxPONDER. As a result, it has a leading position in the U.S. and globally.

Oncotype DX 獨樹一幟。這是唯一具有您在 TAILORx 和 RxPONDER 中看到的證據級別的測試。因此，它在美國和全球都處於領先地位。

So these are the 2 best brands in diagnostics. We will keep investing in them, and they have become standard of care without peer in terms of that Cologuard and its sample type and Oncotype DX, it would be very difficult to replicate that level of [evidence]. So we're probably on these programs and continue to expect big things in the future.

因此，這些是診斷領域的 2 個最佳品牌。我們將繼續對它們進行投資，並且就 Cologuard 及其樣本類型和 Oncotype DX 而言，它們已經成為獨一無二的護理標準，很難復制那種水平的[證據]。所以我們可能正在參與這些計劃，並繼續期待未來的大事。

Your next question comes from the line of Andrew Brackmann from William Blair.

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

Kevin, maybe one for you and sort of building off some of that stool-based commentary there. Just sort of recognizing 2.0 data is going to come. I think you said around midyear. Can you just sort of give us an update on where you expect those data to come in? Anything in particular you'd point to as we put together those scorecards for that data and sort of the longer-term benefits of the model?

凱文，也許是給你的，有點像在那裡建立一些基於凳子的評論。只是識別 2.0 數據即將到來。我想你說的是年中左右。您能否向我們提供有關您希望這些數據進入何處的最新信息？當我們將這些數據的記分卡放在一起時，您有什麼特別要指出的，以及該模型的長期好處嗎？

We expect Cologuard 2.0 to have improved specificity, so a more false positive rate. And we would -- on a secondary basis, we hope to see some improvement in the advanced adenoma detection rate. The main goal is to lower the false positive rate.

我們預計 Cologuard 2.0 會提高特異性，從而降低誤報率。我們會——在次要的基礎上，我們希望看到晚期腺瘤檢出率有所提高。主要目標是降低誤報率。

We have designed Cologuard with more specific markers. We also expect to see improved cost efficiencies and other aspects of Cologuard testing. So that is where we -- that's what we expect. Of course, we won't know until we complete all of the validation testing, and we expect that to occur midyear.

我們設計了具有更具體標記的 Cologuard。我們還希望看到 Cologuard 測試的成本效率和其他方面得到改善。所以這就是我們 - 這就是我們所期望的。當然，在我們完成所有驗證測試之前我們不會知道，我們預計這將在年中發生。

Your next question comes from the line of Dan Brennan from Cowen.

你的下一個問題來自 Cowen 的 Dan Brennan。

Great. Maybe first one, just on the rescreening in the 45 to 49 and then just one question on the EBITDA guidance for '23. So Jeff, can you just clarify, so 8% penetration run rate in 4Q? It seems like a really big number. We're coming up with like 130,000 tests. Is that in the ZIP code? It's, what, 20 million people in total and you divide that by 3 to get the addressable for Cologuard, that's like 6.6 million. And then you got -- you had 8% penetration in 4Q. So we just took 1/4 of that and 8% of that. So maybe a little clarity on the math there and how we -- and kind of how we think about -- I know you guys don't want to disclose too much on these. But since they are material, it'd be great to understand how you're thinking about the impact of rescreening, 45 to 49 in 2023.

偉大的。也許第一個，只是關於 45 到 49 年的重新篩選，然後只是一個關於 23 年 EBITDA 指南的問題。那麼傑夫，你能澄清一下嗎，第四季度的滲透率為 8%？這似乎是一個很大的數字。我們準備進行大約 130,000 次測試。那是在郵政編碼中嗎？它是，什麼，總共有 2000 萬人，你將其除以 3 得到 Cologuard 的可尋址，即 660 萬。然後你得到了 - 你在第四季度有 8% 的滲透率。所以我們只拿了其中的 1/4 和 8%。因此，也許可以清楚地了解那裡的數學以及我們如何 - 以及我們如何思考 - 我知道你們不想透露太多這些。但由於它們很重要，所以很高興了解您如何看待 2023 年 45 到 49 次重新篩查的影響。

And then the second one would just be on the $25 million-plus of adjusted EBITDA, I guess, dollars ex stock comp in 2023. So if you exited 4Q with $5 million, just wondering if that's a conservative number since I would expect you guys to have some nice momentum despite all the investments that you're doing. So I would have thought it'd be a high number in '23. Maybe you could just speak through some of the drivers there.

然後第二個只是超過 2500 萬美元的調整後 EBITDA，我猜，是 2023 年的除股票之外的美元。所以如果你以 500 萬美元退出第四季度，我只是想知道這是否是一個保守的數字，因為我希望你們儘管您正在進行所有投資，但仍有一些不錯的勢頭。所以我原以為它在 23 年會是一個很高的數字。也許你可以通過那裡的一些司機說話。

Sure. A lot there. Obviously, Kevin talked about 45 in rescreening just being significant growth drivers, and that will continue for a long time. Last year, we have put out guidance for 45 of at least $100 million of revenue. We beat that nicely. And for rescreening, we said at least $220 million, we beat that nicely. So both have really good momentum.

當然。那裡有很多。顯然，凱文在重新篩選中談到 45 只是重要的增長動力，而且這種情況將持續很長時間。去年，我們為至少 1 億美元收入中的 45 家發布了指導意見。我們打得很好。對於重新放映，我們說至少 2.2 億美元，我們很好地擊敗了它。所以兩者都有很好的勢頭。

This year, we expect rescreening to about 20% of revenue in total, and that should grow from there. Eventually, this becomes half of our revenue and 45% should have a pretty similar trajectory as rescreenings. So huge drivers there.

今年，我們預計重新篩選佔總收入的 20% 左右，而且應該會繼續增長。最終，這將成為我們收入的一半，45% 的軌跡應該與重新放映的軌跡非常相似。那裡有那麼多的司機。

In Q4, you kind of talked about the overall penetration rate for 45. And just to be clear on the definition here, we're looking at the pool of patients, which is nearly 20 million people and saying that Q4 run rate, call it roughly 125,000 people tested. If you adjust that for the interval and the -- annualize it, we were at about 8% penetration into that younger age group.

在第四季度，你談到了 45 的整體滲透率。為了明確這裡的定義，我們正在研究將近 2000 萬人的患者群體，並說第四季度的運行率，稱之為大約有 125,000 人接受了測試。如果你調整間隔和 - 年化它，我們在那個年輕的年齡組中的滲透率約為 8%。

The reason we highlighted that is because Cologuard got there in about 18 months after USPSTF guideline inclusion for the younger age group. You contrast that to the 50 and above age group, which is that's been the biggest diagnostic client in history. We're at 9% there today. So the point there is really 45 is growing very, very quickly.

我們強調這一點的原因是因為 Cologuard 在 USPSTF 指南納入較年輕的年齡組後大約 18 個月到達那裡。你將其與 50 歲及以上年齡組進行對比，這是歷史上最大的診斷客戶。我們今天的進度為 9%。所以真正的 45 點增長得非常非常快。

The question on adjusted EBITDA. What we're guiding to is flat to $25 million adjusted EBITDA for the year. This really speaks to the power of the platform. You'll recall that we had accelerated the path to profitability. It was going to be '24, the mid-'23. It eventually got there and then in '22.

關於調整後的 EBITDA 的問題。我們指導的是今年調整後的 EBITDA 持平於 2500 萬美元。這確實說明了平台的力量。您會記得我們已經加快了盈利之路。這將是 24 年，23 年中期。它最終到達那裡，然後在 22 年。

For the year now, what we're guiding to is over $150 million of adjusted EBITDA growth. On an incremental adjusted EBITDA margin basis, we're talking of over 75% incremental. So the guidance is the most likely outcome. I'm proud of what the team has delivered here. These are -- I'm very proud of these numbers. It's a significant improvement year-on-year, and it puts us in a position to really continue investing in growth and efficiencies and delivering profitability to investors.

今年，我們指導的是超過 1.5 億美元的調整後 EBITDA 增長。在增量調整後的 EBITDA 利潤率基礎上，我們談論的是超過 75% 的增量。因此，指導是最有可能的結果。我為團隊在這裡交付的成果感到自豪。這些是——我為這些數字感到非常自豪。這是同比顯著改善，它使我們能夠真正繼續投資於增長和效率，並為投資者帶來盈利能力。

Your next question comes from the line of Vijay Kumar from Evercore ISI.

您的下一個問題來自 Evercore ISI 的 Vijay Kumar。

Jeff, one in your -- I guess I had a 2-part question. The 2.0, Cologuard 2.0 results, I know you mentioned increased specificity you, and you expect an increase in advanced adenoma sensitivity. Is there any risk as you take up that specificity that the sensitivity for cancer perhaps, it drops? I know given AA sensitivity going up, perhaps that's not the case. But maybe just talk to us, is there any risk here from a sensitivity perspective heading into these results? And on adjusted EBITDA, Jeff, how should we think about those leverage levels going forward? The incremental leverage math that you just laid out, should that hold true when we think about '24 and '25?

傑夫，你的一個——我想我有一個由兩部分組成的問題。 Cologuard 2.0、Cologuard 2.0 結果，我知道你提到了特異性增加，並且你期望晚期腺瘤敏感性增加。當你接受那種對癌症的敏感性可能下降的特異性時，是否有任何風險？我知道鑑於 AA 敏感性上升，也許情況並非如此。但也許只是跟我們談談，從敏感性的角度來看，這些結果是否存在任何風險？關於調整後的 EBITDA，Jeff，我們應該如何考慮未來的槓桿水平？您剛剛提出的增量槓桿數學，在我們考慮 24 和 25 時是否適用？

Why don't I take the first part, Jeff and you take the second part. So we would expect the cancer sensitivity to be at or above 90%. We would expect somewhere in the neighborhood of 100 cancer samples in the study. So it's in the -- if you recall in the DeeP-C study, we had 65 samples.

為什麼我不參加第一部分，傑夫和你參加第二部分。所以我們預計癌症敏感性達到或超過 90%。我們預計研究中的某個地方大約有 100 個癌症樣本。所以它在——如果你還記得在 Deep-C 研究中，我們有 65 個樣本。

So what have we done to improve the likelihood of success? We, number one, increase the powering of the study. Number two, we've done a significant amount of work to compare the current version of Cologuard with the next-generation version of Cologuard in samples, including samples from the DeeP-C study. So we have a head-to-head comparison which gives us confidence that Cologuard 2.0 performs better than Cologuard 1.0.

那麼我們做了什麼來提高成功的可能性呢？我們，第一，增加研究的力量。第二，我們做了大量工作來比較當前版本的 Cologuard 和下一代 Cologuard 版本的樣本，包括來自 DeeP-C 研究的樣本。因此，我們進行了直接比較，這讓我們相信 Cologuard 2.0 的性能優於 Cologuard 1.0。

You can never control all of the risk because the fundamental population has changed or for example, you see a lot more smaller cancers, harder-to-detect cancers. You don't know that and you can't control [them for it]. So what we have done is developed the very best test with the best markers, the most efficient and powerful DNA capture technologies and deploy that into the study. And we look forward to opening the results of the study and sharing them with you, and that's our thinking on that. Jeff, maybe you take the second one.

你永遠無法控制所有的風險，因為基本人口已經改變，或者例如，你看到更多更小的癌症，更難檢測的癌症。你不知道，你無法控制[他們]。因此，我們所做的是用最好的標記、最有效和最強大的 DNA 捕獲技術開發出最好的測試，並將其部署到研究中。我們期待公開研究結果並與您分享，這就是我們的想法。傑夫，也許你拿第二個。

This is Jeff. On the leverage question, look, this model has been built to scale, to scale efficiently, ultimately deliver positive free cash flow, which we expect to reach in '24. Can we sustain 75% plus incrementals? I hope so, but that's a pretty tall order, Vijay.

這是傑夫。在槓桿問題上，你看，這個模型是為了擴大規模、有效擴大規模而建立的，最終提供正的自由現金流，我們預計在 24 年實現這一目標。我們能否維持 75% 以上的增量？我希望如此，但這是一個相當高的要求，Vijay。

When I think about leverage going forward, the best way to do it is to drive a really strong top line. I know every team are going to do that. We've got some nice levers to pull when I walk through the P&L, thinking of gross margin. We're targeting over 80% gross margin for the 2 key products here, Cologuard and Oncotype. Oncotype is there, I'm confident Cologuard will get there over time. So I expect some good gross margin improvement.

當我考慮未來的槓桿作用時，最好的方法是推動真正強勁的收入。我知道每個團隊都會這樣做。當我瀏覽損益表時，考慮到毛利率，我們有一些很好的槓桿可以拉動。我們的目標是這裡的兩個主要產品 Cologuard 和 Oncotype 的毛利率超過 80%。 Oncotype 就在那裡，我相信 Cologuard 會隨著時間的推移到達那裡。所以我預計毛利率會有所改善。

The G&A, this year, I talked about that Thrive earn-out payment is driving higher G&A growth on a GAAP basis, but you adjust for that it's mid-single-digit growth. Over time, the G&A leverage will improve. Sales and marketing. The [minute], there is really to make sure we're always investing in the smart growth and everyone saw a nice drop there. So we're seeing a really good leverage within sales and marketing.

G&A，今年，我談到 Thrive 收入支付在 GAAP 基礎上推動更高的 G&A 增長，但你調整它是中個位數的增長。隨著時間的推移，G&A 槓桿率將會提高。銷售和營銷。 [分鐘]，確實是為了確保我們始終投資於智能增長，每個人都看到了不錯的下降。因此，我們在銷售和營銷中看到了非常好的影響力。

R&D, the way we'll get leverage there is to focus on the highest impact opportunities, and Kevin has talked about those today. Over time, as we get the benefit, Cologuard to the MRD programs, multi-cancer as we get the benefit from those programs, that will help drive additional leverage through the P&L.

研發，我們在那裡獲得影響力的方式是專注於最具影響力的機會，凱文今天談到了這些。隨著時間的推移，隨著我們從 MRD 計劃中受益，Cologuard 和多癌症，因為我們從這些計劃中受益，這將有助於通過 P&L 推動額外的槓桿作用。

Your next question comes from the line of Catherine Schulte from Baird.

您的下一個問題來自 Baird 的 Catherine Schulte。

And thanks for showing that slide on rep productivity. It's great to see Cologuard revenue per field continuing to trend upwards. But I'm curious what's that number? What it looks like pre-COVID? And if you can talk to where you think that number should go over time?

並感謝您展示代表生產力的幻燈片。很高興看到 Cologuard 每個領域的收入繼續呈上升趨勢。但我很好奇這個數字是多少？它看起來像 COVID 之前的情況？如果你能談談你認為隨著時間的推移這個數字應該去哪裡？

Catherine, this is Jeff. Pre-COVID, I think there's a lot of moving pieces there. When you think of the Pfizer relationship. It's a great partnership. It just does change the dynamic as well, which is why we focused on the quarters that we did display on the slide deck.

凱瑟琳，這是傑夫。在 COVID 之前，我認為那裡有很多動人的片段。當你想到輝瑞的關係時。這是一個很好的伙伴關係。它確實也改變了動態，這就是為什麼我們專注於我們在幻燈片上顯示的季度。

Going forward, where can it go? I would like start but Everett please chime in. And there's a long ways to grow when you think of that market penetration number at 9% in that 50-plus age group. Longer term, I'm confident we can get to at least 40%. And I think we've already got a strong team in place. So I expect that productivity to go way up all the time, but Everett?

往前走，它能去哪裡？我想開始，但埃弗雷特請插話。當你想到 50 歲以上年齡組的市場滲透率達到 9% 時，還有很長的路要走。從長遠來看，我相信我們至少可以達到 40%。我認為我們已經擁有一支強大的團隊。所以我預計生產力會一直提高，但埃弗雷特呢？

No, thanks, Jeff, and thanks, Catherine, for the question. I'm really proud of what the commercial team has done over the past years since we've launched Cologuard, and we continue to evolve the commercial team. There's many things that are contributing to the productivity. I'll just highlight a couple of things. Number one is the way in which we've evolved our territories. We've cleaned up the overlap in territories, which have driven deeper customer relations. And I think that's driving a lot of the acceptance of why now Cologuard is a preferred choice for screening.

不，謝謝杰夫，也謝謝凱瑟琳提出的問題。自從我們推出 Cologuard 以來，商業團隊在過去幾年所做的工作讓我感到非常自豪，我們將繼續發展商業團隊。有很多因素有助於提高生產力。我只強調幾件事。第一是我們發展領土的方式。我們已經清理了區域重疊，這推動了更深層次的客戶關係。而且我認為這推動了很多人接受為什麼現在 Cologuard 是篩查的首選。

Number two, we use data and analytics now in terms of who to call on, when to call on, how often we call on those customers. And we're just much better now in looking and knowing exactly who to call on for the growth, and we review those analytics and who we're calling on a weekly and monthly, very rigorous process in our commercial organization. We just don't do it centrally, but we're now doing it as a market and area level of where that execution is happening.

第二，我們現在在拜訪誰、何時拜訪、拜訪這些客戶的頻率方面使用數據和分析。而且我們現在在尋找和確切知道為增長而呼籲誰方面做得更好，我們審查了這些分析以及我們每周和每月在我們的商業組織中非常嚴格的流程中呼籲誰。我們只是不集中進行，但我們現在將其作為執行發生的市場和區域級別來進行。

And then Jeff and Kevin mentioned in terms of we're going to always invest for growth. We're really focused on health systems. That's where a lot of our customers and patients are. We've increased our amount of account executives at the health systems level, and the conversations now that we're having around the screening is our health systems are now coming to us and how can we partner for those hard to screen patients where they need to close the care gaps. We saw a lot of that at the tail end of 2022, and that's going to continue in 2023. I feel bullish that our productivity will continue to improve.

然後傑夫和凱文提到我們將始終投資於增長。我們真正專注於衛生系統。那是我們很多客戶和患者所在的地方。我們已經增加了衛生系統層面的客戶經理人數，現在我們圍繞篩查進行的對話是我們的衛生系統現在正在向我們求助，我們如何才能在需要的地方為那些難以篩查的患者提供合作縮小護理差距。我們在 2022 年底看到了很多這樣的情況，而且這種情況將在 2023 年繼續。我看好我們的生產力將繼續提高。

Your next question comes from the line of Brandon Couillard from Jefferies.

您的下一個問題來自 Jefferies 的 Brandon Couillard。

Just a 2-part question in terms of the guide for the year. Jeff, what's embedded for the stock comp expense? And then, Kevin, conceptually speaking, if the top line is, let's say, running ahead of plan as we move through the year, would it be your preference to reinvest some of those dollars but still deliver on the profitability target or would you let that drop down?

就年度指南而言，這只是一個由兩部分組成的問題。傑夫，股票補償費用包含什麼？然後，凱文，從概念上講，如果我們今年的收入比計劃提前，那麼你是否願意將其中一些美元再投資但仍能實現盈利目標，或者你會讓那個掉下來？

Brandon, this is Jeff. The first one, it's on comp. I think we've given you the -- kind of all the pieces between when you look at the gap, the deal that have grown in OpEx, adjusted EBITDA. So I think you can -- stock comp is probably the biggest piece between there. If you look at last year, which you have that you'll have in the case, if you do already, it's going to grow from there as if you look back at the head count growth over time. But I think that's enough to give you the math between the GAAP number and adjusted EBITDA number. Second question on reinvestment.

布蘭登，這是傑夫。第一個，它在 comp 上。我認為我們已經為您提供了——當您查看差距時，在 OpEx 中增長的交易、調整後的 EBITDA 之間的所有部分。所以我認為你可以——股票補償可能是兩者之間最大的部分。如果你看一下去年，如果你已經這樣做了，那麼它會從那裡開始增長，就好像你回顧一下隨著時間的推移人數增長一樣。但我認為這足以讓您了解 GAAP 數字和調整後的 EBITDA 數字之間的數學關係。第二個關於再投資的問題。

So in terms of investment, we're still making enormous investments in new product programs. We've touched upon the 3 big ones, colon cancer, multi-cancer early detection and the MRD program. So we also have some minor programs that we're working on in liver, esophageal cancer and endometrial cancer. We're making those investments today. We're making significant investments in our IT infrastructure.

因此，在投資方面，我們仍在對新產品計劃進行大量投資。我們已經談到了 3 大項目，結腸癌、多癌症早期檢測和 MRD 計劃。因此，我們也有一些針對肝癌、食道癌和子宮內膜癌的小型項目。我們今天正在進行這些投資。我們正在對我們的 IT 基礎架構進行大量投資。

So would we selectively reinvest some of those profits? Yes. Are we bias towards and leaning towards letting that fall through? The answer is, yes. The whole company is on board with that. They're driving to it. We're all rolling together as one team to show the profitability engine that we have, and that's very important to us.

那麼我們會選擇性地再投資其中的一些利潤嗎？是的。我們是否偏向並傾向於讓它落空？答案是肯定的。整個公司都同意這一點。他們開車去。我們作為一個團隊團結在一起，展示我們擁有的盈利引擎，這對我們來說非常重要。

Your next question comes from the line of Matt Sykes from Goldman Sachs.

你的下一個問題來自高盛的 Matt Sykes。

Maybe the first one just on compliance. Jeff, you mentioned some of the enhancements you were making to compliance. And if we add in the rescreen opportunity over time. Could you maybe help us frame where you think compliance can go to for Cologuard over the next year or 2?

也許第一個只是關於合規性。 Jeff，您提到了您為合規性所做的一些改進。如果我們隨著時間的推移增加重新篩選的機會。您能否幫助我們構建您認為 Cologuard 在未來一年或兩年的合規性？

And then -- and just secondly, I'll ask them both upfront. But secondly, just on Oncotype outside of the U.S., I think you mentioned that sort of the main growth area for you. Could you maybe talk about what you see as sort of the growth rate for ex U.S. within Oncotype for this year?

然後——其次，我會先問他們兩個。但其次，就美國以外的 Oncotype 而言，我認為你提到了那種主要增長領域。您能否談談您對今年 Oncotype 中除美國以外的增長率的看法？

Yes, this is Jeff. I think I'll handle both of those. Cologuard patient compliance, the way we typically report this out is looking at test conducted 12 to 18 months prior. That rate is in the mid-60s percent, so about 2 of the 3 patients comply with Cologuard. Over time, I expect that to go above 70, possibly to 75. The reason why I'm confident we'll get there is that on rescreening patients, the overall patient compliance rate is 15 to 20 points higher than first line patients.

是的，這是傑夫。我想我會處理這兩個問題。 Cologuard 患者依從性，我們通常報告這一點的方式是查看 12 到 18 個月前進行的測試。該比率在 60% 左右，因此 3 名患者中約有 2 名遵守 Cologuard。隨著時間的推移，我預計會超過 70，可能會達到 75。我相信我們會達到目標的原因是，在重新篩查患者時，總體患者依從率比一線患者高 15 到 20 個百分點。

So over time, that's going to be a big driver of overall lift in the patient's compliance rate. And we're making significant investments to enhance that customer experience, better ways for outreach, better ways to make it even simpler to Cologuard. And over time, that will naturally bring that patient compliance rate up.

因此，隨著時間的推移，這將成為患者依從率整體提升的重要推動力。我們正在進行大量投資來增強客戶體驗，更好的外展方式，更好的方式讓 Cologuard 變得更簡單。隨著時間的推移，這自然會提高患者的依從率。

The second question on Oncotype DX international growth. There's a significant runway ahead, thanks to the strength of the team there, the strength of the evidence that Kevin alluded to, Oncotype globally is opening up in new markets through reimbursement and access. What we've baked into this year is in the U.S., growth there is approaching prevalence plus a point or so.

關於 Oncotype DX 國際增長的第二個問題。由於那裡團隊的實力，凱文提到的證據的力量，Oncotype 全球正在通過報銷和准入在新市場開闢一條重要的跑道。我們今年所關注的是在美國，那裡的增長接近流行率加上一個點左右。

So I think kind of low to mid-single digits. International will grow faster. It can be easily into the double digits depending on new markets that launched within a given year. This year, we expect Japan, which could eventually be the biggest market outside the U.S., we expect Japan to come on potentially midyear, and that can be a big driver starting midyear and into next year.

所以我認為是中低個位數。國際將增長更快。根據給定年份內推出的新市場，它可以很容易地達到兩位數。今年，我們預計日本最終可能成為美國以外最大的市場，我們預計日本可能會在年中出現，這可能是從年中開始到明年的重要推動力。

Your next question comes from the line of Jack Meehan from Nephron Research.

您的下一個問題來自 Nephron Research 的 Jack Meehan。

My questions for Kevin are on the blood screening programs. First, can you give an update on the blood portion of Blue-C? When you expect that to read out? And then second, on MCED, talked about validating additional markers. Can you just talk about how that might be similar or different to what you presented at ESMO and what that might mean for time line for the SOAR study?

我要問凱文的問題是關於血液篩查計劃的。首先，你能更新一下 Blue-C 的血液部分嗎？您希望什麼時候讀出？其次，在 MCED 上，討論了驗證其他標記。您能否談談這與您在 ESMO 上展示的內容有何相似或不同之處，以及這對 SOAR 研究的時間表可能意味著什麼？

Sure. On the first program, we haven't given specific guidance as to when the colon cancer blood program will read out. The team that is focused on our colon cancer programs are focused both on stool, Cologuard 2.0 and blood. There's a huge amount of effort that is required to -- prior to testing samples.

當然。在第一個節目中，我們還沒有給出具體的指導，關於結腸癌血液節目什麼時候會讀出。專注於我們結腸癌項目的團隊同時關注糞便、Cologuard 2.0 和血液。在測試樣品之前需要付出大量的努力。

So there is a rigorous analytical validation studies that are required verification studies, software development and validation. And so there is an enormous amount of rigor that goes into that and preparing the automation entire program and submission that goes to the FDA. You don't make changes easily. So you need to make sure that, that -- the manufacturing capability and all the studies are locked down.

因此，有一個嚴格的分析驗證研究，需要驗證研究、軟件開發和驗證。因此，在準備自動化整個程序和提交給 FDA 的過程中需要非常嚴格。你不會輕易做出改變。所以你需要確保——製造能力和所有研究都被鎖定。

So the Cologuard 2.0, next-generation Cologuard is first, and then that team will shift its focus to the validation and verification studies for CRC blood afterwards. In the coming quarters, we'll provide more clarity as to when that pivotal study from the blood portion of the CRC program will be complete.

所以 Cologuard 2.0，下一代 Cologuard 是第一個，然後該團隊將把重點轉移到 CRC 血液的驗證和驗證研究上。在接下來的幾個季度，我們將更清楚地說明 CRC 項目血液部分的關鍵研究何時完成。

In terms of the MCED marker validation study, we have interim and full [trials] of the test designed kind of a lockdown study prior to moving into the large prospective study. That study, we expect to read out this year. So 2 different studies will read out during the year, and that is a much larger version of the data that you saw at ESMO last year.

就 MCED 標記驗證研究而言，在進入大型前瞻性研究之前，我們對測試設計了一種鎖定研究的中期和全面[試驗]。那項研究，我們希望在今年宣讀出來。因此，今年將讀出 2 項不同的研究，這是你去年在 ESMO 看到的數據的更大版本。

That is -- that will lock down our final marker classes. And then we expect SOAR to start next year. We would expect that to start in the first half of next year. And all of -- the team right now is working on perfecting the test, making sure that, that test and the automation surrounding it is locked down before we start that study.

也就是說——這將鎖定我們最終的標記類。然後我們預計 SOAR 將於明年開始。我們預計這將在明年上半年開始。所有 - 團隊現在正在努力完善測試，確保在我們開始研究之前鎖定該測試和圍繞它的自動化。

Again, once you start a prospective study or a cancer screening test, you don't make changes to that product. So it's totally lockdown.

同樣，一旦您開始前瞻性研究或癌症篩查測試，您就不會對該產品進行任何更改。所以它是完全鎖定的。

Your next question comes from the line of Mark Massaro from BTIG.

你的下一個問題來自 BTIG 的 Mark Massaro。

Congrats on the progress. My first one is on MRD. So it's great to see your planned LDT launch later this year in colorectal cancer. When can we expect to see additional data, which would support reimbursement? And have you had discussions with any Medicare contractors?

祝賀進步。我的第一個在 MRD 上。所以很高興看到您計劃在今年晚些時候在結直腸癌中推出 LDT。我們什麼時候可以看到額外的數據來支持報銷？您是否與任何 Medicare 承包商進行過討論？

And then my second question is on the Thrive multi-cancer initiative. I appreciate that additional data will be rolling out this year. But maybe, Kevin, can you just give us a sense, this is not like you're rolling out an LDT. This is kind of a higher risk, bigger opportunity. What types of factors do you think might change in the landscape over the next few years that could perhaps increase the probability of success? And then can you give us a sense for the size of the patient enrollment? Is it somewhere near the 80,000 to 100,000-plus mark?

然後我的第二個問題是關於 Thrive 多癌症倡議。我很高興今年將推出更多數據。但也許，凱文，你能不能給我們一個感覺，這不像是在推出 LDT。這是一種更高的風險，更大的機會。您認為未來幾年可能會改變哪些類型的因素可能會增加成功的可能性？然後你能告訴我們患者登記的規模嗎？它是否接近 80,000 到 100,000 多點？

Okay. So the first question in terms of what are the things that are going to change to make a multi-cancer early detection this whole category of testing more likely to be successful. Certainly, congress creating Medicare benefit category is one. That's important. And we expect that legislation to be reintroduced in this congress.

好的。因此，第一個問題是，為了使多癌症早期檢測這一整類測試更有可能成功，將會發生哪些變化。當然，國會創建醫療保險福利類別就是其中之一。這很重要。我們希望在本屆國會中重新引入該立法。

Remember, last year, there were more than 50% of congress were cosponsors, equal number of Democrats and Republicans. So we're working hard right now to make sure that Medicare beneficiaries will have access to this incredible new category of testing.

請記住，去年有超過 50% 的國會是共同提案國，民主黨和共和黨的人數相等。因此，我們現在正在努力確保 Medicare 受益人能夠獲得這種令人難以置信的新型檢測。

The evidence that is being built by exact like others in this field shows great promise for the ability to shift the stage of cancer detection broadly across many, many different types of cancers. From later stage, more difficult-to-treat cancer to earlier cancers where the therapy frequently is surgery with an intent to cure. That's a big shift. And the more evidence that is generated that we -- there is more excitement that is being built in this space.

與該領域的其他人一樣，正在建立的證據表明，有能力在許多不同類型的癌症中廣泛轉移癌症檢測階段。從晚期、更難治療的癌症到早期癌症，治療通常是旨在治癒的手術。這是一個很大的轉變。而且產生的證據越多，我們 - 在這個空間中正在建立更多的興奮。

We believe that we have a significant advantage because of the strength of our Cologuard screening team, infrastructure, lab capability, et cetera, perfectly positions us for success. This is going to play out over a long period of time. We believe there are well north of 100 million people in the U.S. alone, many more outside the U.S. that are going to benefit from the test.

我們相信，由於我們 Cologuard 篩選團隊、基礎設施、實驗室能力等的實力，我們擁有顯著的優勢，完美地為我們的成功奠定了基礎。這將在很長一段時間內發揮作用。我們相信僅在美國就有超過 1 億人，美國以外的更多人將從測試中受益。

And the key takeaway here is that there is no therapy as effective as earlier detection. Earlier detection means your therapy plan is going to be very different. And that's the goal of program. We're excited about it. We're committed to making this happen. And we're doing the work to -- the rigorous scientific work to develop the best test.

這裡的關鍵要點是，沒有比早期檢測更有效的療法了。早期檢測意味著您的治療計劃將大不相同。這就是計劃的目標。我們對此感到興奮。我們致力於實現這一目標。我們正在努力——開展嚴格的科學工作來開發最好的測試。

Mark, you want to also ask on MRD. So we plan to publish data on upcoming scientific conference in the tumor-informed version of our tests, recall working on both tumor-informed and tumor-naive. That tumor-informed in colon cancer puts us one step closer to bring that test to market, which we plan to do later this year versus an LDT.

馬克，你還想在 MRD 上提問。因此，我們計劃在我們測試的腫瘤信息版本中發布即將舉行的科學會議的數據，回想一下在腫瘤信息和腫瘤天真方面的工作。結腸癌中的腫瘤信息讓我們更接近將該測試推向市場，我們計劃在今年晚些時候將其與 LDT 進行比較。

Next year, we'll submit retrospective prospective data to MolDX, hoping to secure [reverse] with that. Behind the scenes, we've been working on pivotal studies for both colon and breast that eventually what helps that -- we think the standard for evidence in this space.

明年，我們將向 MolDX 提交回顧性前瞻性數據，希望以此確保[逆轉]。在幕後，我們一直在對結腸和乳房進行關鍵研究，最終會有所幫助——我們認為這是該領域的證據標準。

We feel good. Same thing with multi-cancer and leveraging the foundation we built in primary care, MRD, given our positioning with oncologists, whatever the team has done there, building deep, deep relationships. As you know, 98% of oncologists have ordered Oncotype DX from us. So we think we can leverage the same strength of the commercial foundation into MRD.

我們感覺很好。考慮到我們與腫瘤學家的定位，無論團隊在那裡做了什麼，建立深厚的關係，多癌症和利用我們在初級保健 MRD 中建立的基礎也是如此。如您所知，98% 的腫瘤學家都向我們訂購了 Oncotype DX。因此，我們認為我們可以將商業基礎的相同實力利用到 MRD 中。

Your next question comes from the line of Dan Arias from Stifel.

您的下一個問題來自 Stifel 的 Dan Arias。

Kevin, back on the pipeline. Just any update on the thoughts around commercialization for Cologuard 2.0? I think at one point, that was a potential '23 event. So just curious if that's still a possibility. And then how dependent on that, would commercialization be on just performance and data around the test versus other factors like sales training, reimbursement, et cetera?

凱文，回到管道中。關於 Cologuard 2.0 商業化的最新想法？我認為在某一時刻，那是一個潛在的 23 事件。所以只是好奇這是否仍然有可能。那麼商業化是否僅取決於測試的性能和數據，而不是銷售培訓、報銷等其他因素？

Sure. We expect, Dan, to submit this year, and it's at least 6 months with the FDA before approval. So that puts us into next year with the launch. A lot of prelaunch activity will go on. Certainly, that launch will incorporate the new and different sensitivity and specificity.

當然。 Dan，我們預計今年提交，並且在批准之前至少需要 6 個月的時間與 FDA 聯繫。所以這讓我們進入明年的發布。許多啟動前活動將繼續進行。當然，該發射將包含新的和不同的敏感性和特異性。

And then some of the long mundane aspects of launch would include the billing code for the new version of Cologuard, does it change, doesn't it change, payer relationships, Medicare, et cetera, you need to do a lot of work there before you switch over to a new test lab automation changes, et cetera. So that will be a very thoughtful transition from the great current version of Cologuard to an even better version of Cologuard. The nice thing is we have a great test in Cologuard today, and it's all upside for patients, health systems and Exact Sciences' shareholders when we bring the new innovation to patients.

然後，發布的一些冗長的平凡方面將包括新版本 Cologuard 的計費代碼，它會改變嗎，它不會改變，付款人關係，醫療保險等等，您需要在此之前做很多工作您切換到新的測試實驗室，自動化發生變化，等等。所以這將是一個非常周到的從 Cologuard 當前版本到更好版本 Cologuard 的過渡。好消息是我們今天對 Cologuard 進行了很好的測試，當我們為患者帶來新的創新時，這對患者、衛生系統和 Exact Sciences 的股東來說都是有利的。

And just to add to that, recall that late last year, we pulled ahead. One of the key benefits of Cologuard 2.0. We pulled ahead internally what we call Cologuard 1.5. What Cologuard 1.5 did is it extended the stability of that patient sample by 1/3. That's important because it helps to get more of those tests back to our lab with the sample that we can still use [if that] expired.

除此之外，回想一下去年年底，我們取得了領先。 Cologuard 2.0 的主要優勢之一。我們在內部領先我們所謂的 Cologuard 1.5。 Cologuard 1.5 所做的是將患者樣本的穩定性提高了 1/3。這很重要，因為它有助於將更多的測試帶回我們的實驗室，我們仍然可以使用[如果]過期的樣本。

So to date, this new version of the kit, this new Cologuard 1.5 has helped over 45,000 samples that come back to our lab without expiring. Now some of those we could have gone on to recollect before. But it creates an overall better patient experience, more revenue for us, better gross margins for us. So the team is not standing by idly by any means, they're pulling ahead this big benefit. Overall this year, that will increase completed test by at least a point.

所以到目前為止，這個新版本的試劑盒，這個新的 Cologuard 1.5 已經幫助超過 45,000 個樣本返回我們的實驗室而不會過期。現在，我們可以繼續回憶其中的一些。但它創造了更好的整體患者體驗，為我們帶來更多收入，為我們帶來更高的毛利率。因此，團隊不會以任何方式袖手旁觀，他們正在推動這一巨大利益。總體而言，今年，這將使完成的測試至少增加一個百分點。

And then commercially, we're already there. We know our targets, obviously, as Kevin said, with Cologuard on the market now, it will be a seamless transition from a selling and marketing standpoint.

然後在商業上，我們已經在那裡了。顯然，正如凱文所說，我們知道我們的目標，隨著 Cologuard 現在上市，從銷售和營銷的角度來看，這將是一個無縫過渡。

Your next question comes from the line of Puneet Souda from SVB Securities.

您的下一個問題來自 SVB Securities 的 Puneet Souda。

So first one is you mentioned the 8% penetration for 45 to 49 year old. What's the ceiling for that penetration given the momentum you're seeing here? And then on the MCED data, I mean, should we be expecting that at AACR or ASCO or later in the year at ESMO?

所以第一個是你提到 45 到 49 歲的 8% 的滲透率。鑑於您在這裡看到的勢頭，這種滲透的上限是多少？然後關於 MCED 數據，我的意思是，我們是否應該在 AACR 或 ASCO 或今年晚些時候在 ESMO 期待這些數據？

I'll take the first part. Jeff, you can take the second part. In terms of the ceiling, we think that the ceiling is higher than the 40% penetration that we've long guided to for Cologuard in that earlier age group because people who are 45 to 49 typically are busier than retirees, and it's more of a challenge for them to schedule a screening colonoscopy, which can take 1.5 days of your life. Typically, you're -- a portion of your week that you're normally working.

我先講第一部分。傑夫，你可以參加第二部分。就上限而言，我們認為上限高於我們長期以來為 Cologuard 在較早年齡組中設定的 40% 滲透率，因為 45 至 49 歲的人通常比退休人員更忙，而且更像是挑戰他們安排篩查結腸鏡檢查，這可能需要您生命中的 1.5 天。通常情況下，你是——你一周中正常工作的一部分。

So we also have been able to educate and reach people digitally, our digital investments and social media marketing will increase over time. So Cologuard is a test that fits within their lifestyle. Do we get to 50% to 60% penetration? That wouldn't surprise me over time in that age group. And what you're seeing is you're seeing the endoscopy suite are very, very busy today.

因此，我們也能夠以數字方式教育和接觸人們，我們的數字投資和社交媒體營銷將隨著時間的推移而增加。因此，Cologuard 是一項適合他們生活方式的測試。我們能達到 50% 到 60% 的滲透率嗎？隨著時間的推移，在那個年齡段，我不會感到驚訝。你看到的是你看到內窺鏡檢查室今天非常非常忙。

Any notion that Cologuard was going to slow down the business of gastroenterologists endoscopy suite is just not going to be accurate, in fact, it helped them to focus. But the -- and there is an opportunity for Cologuard, and is being ordered more frequently in that patient population because the risk of colon cancer is lower and GIs are -- and health systems are focusing on getting those people screened, it goes into their colon cancer quality ratings through Cologuard, visiting last week with primary care physicians who have very busy practices, they are focused on Cologuard.

任何關於 Cologuard 將減緩胃腸病學家內窺鏡套件業務的想法都是不准確的，事實上，它幫助他們集中註意力。但是 - Cologuard 有機會，並且因為結腸癌的風險較低而胃腸道疾病 - 並且衛生系統正在專注於對這些人進行篩查，它進入了他們的患者群體通過 Cologuard 進行結腸癌質量評級，上周訪問了非常忙碌的初級保健醫生，他們專注於 Cologuard。

One office I met switched 100% to Cologuard. Why? Because the GIs are so busy in that part of the country that they don't want to see more average risk patients. So we see that Cologuard will continue to grow because it's easy, it's at home, it's accurate. Jeff, I think there was a second part of that question.

我遇到的一個辦公室 100% 切換到 Cologuard。為什麼？因為地理標誌在這個國家的那個地區太忙了，他們不想看到更多的普通風險患者。所以我們看到 Cologuard 將繼續增長，因為它很容易，它在家裡，它很準確。傑夫，我認為這個問題還有第二部分。

Puneet, this is Jeff. The -- Everett's team has done a really good job generating a wealth of evidence to help build out this new category. As Kevin talked about, there's 2 sets of data coming this year. The first one, I don't think we'll get AACR. I don't know the conference for sure, but I would think midyear on the first set and then a full timing for the second set. When we know what conference, though, we'll let you know.

普尼特，這是傑夫。 - Everett 的團隊在生成大量證據以幫助建立這一新類別方面做得非常出色。正如凱文所說，今年有兩組數據。第一個，我認為我們不會獲得 AACR。我不確定這次會議，但我認為第一盤是年中，然後是第二盤的完整時間。不過，當我們知道是什麼會議時，我們會通知您。

Your next question comes from the line of Patrick Donnelly from Citi.

你的下一個問題來自花旗的 Patrick Donnelly。

Jeff, maybe one for you just on kind of the cadence of the year coming out of the strong 4Q. I know even going back to the conference in January, you were talking about 4Q had some benefits. I think you mentioned the billing enhancements on the call here. No surprise, 1Q down sequentially on Cologuard.

傑夫，也許一個給你的只是關於強勁的第四季度出現的一年節奏。我知道即使回到 1 月份的會議上，你在談論 4Q 也有一些好處。我想你在此處的電話中提到了計費增強功能。毫不奇怪，第一季度 Cologuard 連續下跌。

Can you just talk about, are we getting back to that normal seasonality? Obviously, again, 4Q had a great inflection. You talked about all the factors there. So how do we think about that going forward into '23? It's been a weird couple of years, obviously, in terms of the impacts you guys have seen. So how do you think about the cadence of this year both on the top line with Cologuard? And then also maybe on the EBITDA side, if there's anything we should be looking out for there in terms of expense timing?

你能談談，我們回到正常的季節性了嗎？顯然，4Q 再次出現了很大的變化。你談到了那裡的所有因素。那麼我們如何考慮進入 23 年呢？很明顯，就你們所看到的影響而言，這幾年很奇怪。那麼你如何看待今年與 Cologuard 一起上線的節奏？然後也許在 EBITDA 方面，如果有什麼我們應該在費用時間方面注意的地方？

So Patrick, the typical cadence of Cologuard hasn't changed. There -- it's really driven by primary care utilization trends. So what those are is that typically start the year if people are coming off the holidays, deductible just reset. So primary care use is typically lower in January.

所以 Patrick，Cologuard 的典型節奏沒有改變。在那裡——它真的是由初級保健利用趨勢驅動的。因此，如果人們休假，通常從年初開始，免賠額就會重新設置。因此，一月份初級保健的使用率通常較低。

Things build until Memorial Day at the end of May. And then over the summer that typically flatter as typical on vacations and our focus is much on primary care. At about mid-August or Labor Day, things pick back up and typically climb pretty steeply until Thanksgiving timing and then slow down over the holidays as people go on to get on to vacations.

事情一直持續到五月底的陣亡將士紀念日。然後在整個夏天，這通常會像假期一樣受寵若驚，我們的重點主要放在初級保健上。大約在 8 月中旬或勞動節，情況會好轉，通常會在感恩節前急劇攀升，然後隨著人們繼續休假而在假期放慢速度。

And what that means for Cologuard, there's about a 30-day lag between a primary care visit, and we would recognize revenue. That's typically why you see a step down from Q4 to Q1. And I only expect that to change going forward. However, our business is becoming more predictable, more predictable. You got more stable growth drivers, as Everett's team have done a really nice job building out a whole wealth of different drivers. It's not just tied to one thing anymore.

這對 Cologuard 意味著什麼，初級保健訪問之間大約有 30 天的滯後，我們會確認收入。這通常就是為什麼你會看到從第四季度下降到第一季度的原因。我只希望這種情況會在未來發生變化。然而，我們的業務正變得越來越可預測，越來越可預測。你有更穩定的增長動力，因為埃弗雷特的團隊在構建大量不同的驅動力方面做得非常好。它不再只與一件事有關。

From a Q1 this year standpoint, there's a couple of unique things that are happening. Everybody seeing the flu data. The flu is really mild this year. Relative to most years, flu is normally a headwind to us and others in early Q1, that headwind is really nonexistent this year.

從今年第一季度的角度來看，有幾件獨特的事情正在發生。每個人都看到了流感數據。今年的流感真的很溫和。相對於大多數年份，流感通常在第一季度初對我們和其他人來說是不利因素，今年這種不利因素確實不存在。

So I think almost equal, Q1 a little stronger this year. Also some of the carryover benefits that I talked about earlier from enhancements to both our patient compliance engine and our billing systems, we're picking up a little bit of catch-up revenue on both those things.

所以我認為幾乎相等，今年 Q1 更強一些。此外，我之前談到的一些結轉收益來自於我們的患者合規引擎和計費系統的增強，我們在這兩個方面都獲得了一些追趕收入。

So all told, Q1 seasonally stronger this year as you think about phasing throughout the year, don't expect that same sequential build Q1 to Q2 this year, as you would normally. From an adjusted EBITDA standpoint, Q1 typically has the lowest profitability of the year because of the top line being a little lighter seasonally, and expenses are a bit higher as you roll into a new year, and we've got some unique sales and marketing events in Q1 also. So lighter profitability in Q1, but overall strength to the year from a profit standpoint. Again, significant pickup year-on-year in adjusted EBITDA.

總而言之，當您考慮全年分階段進行時，今年第一季度季節性更強，不要期望今年第一季度到第二季度會像往常一樣連續構建。從調整後的 EBITDA 的角度來看，第一季度的盈利能力通常是一年中最低的，因為季節性收入略微減少，而且隨著新的一年的到來，費用會更高一些，而且我們有一些獨特的銷售和營銷第一季度的事件也是如此。因此，第一季度的盈利能力較弱，但從利潤的角度來看，今年的整體實力。同樣，調整後的 EBITDA 同比顯著回升。

Your next question comes from the line of Andrew Cooper from Raymond James.

你的下一個問題來自 Raymond James 的 Andrew Cooper。

Maybe first, just, Jeff, you mentioned some of the prior period collections and some of the improvements in compliance. Can you give us a sense for precising of that in the fourth quarter?

也許首先，Jeff，您提到了一些前期收款和合規性方面的一些改進。您能否讓我們了解一下第四季度的精確度？

And then I think it was about a year ago, maybe this call last year, you talked a little bit about a chance for pricing and ASP to continue to climb a little bit. So can you just give us an update, have you been able to capture a little bit more on sort of apples-to-apples ASP and what that looks like and how that impacts the move to profitability as well, assuming pretty steep drop down there?

然後我想大約是一年前，也許是去年的這個電話，你談到了定價和 ASP 繼續攀升的機會。那麼，您能不能給我們更新一下，您是否能夠更多地了解同類產品的 ASP 以及它的外觀以及它如何影響盈利能力，假設那裡的跌幅非常大？

Andrew, in Q4, the base business exceeded expectations. This is the things that Kevin and Everett have talked about. It's the strength of the relationships with health systems, the sales force productivity. Cologuard rescreenings, 45, all those things drove the upside.

安德魯，在第四季度，基礎業務超出了預期。這就是凱文和埃弗雷特談到的事情。這是與衛生系統、銷售人員生產力的關係的力量。 Cologuard 重新篩選，45 次，所有這些因素推動了上漲。

The reason I called out some of these other items is because we didn't want people to take Q4 and then assume that's kind of the new base run rate going forward. I look at it as more sweetener. Sweetener in terms of a couple of things. Again, it's the enhancements to our billing systems, enhancements to patient compliance. What happened? Let's say, you turn those in early October. Well, because of those enhancements, we were able to capture patients and revenue that otherwise would have hit in Q2 and Q3, we pick on Q4.

我提出其中一些其他項目的原因是因為我們不希望人們接受第四季度，然後假設這是未來的新基本運行率。我把它看作更甜的東西。就幾件事而言，甜味劑。同樣，這是對我們計費系統的增強，對患者依從性的增強。發生了什麼？比方說，你在十月初把那些。好吧，由於這些改進，我們能夠獲得患者和收入，否則這些收入會在第二季度和第三季度受到影響，我們選擇第四季度。

So it's a good guide there on a go-forward basis now, our revenue per test or ASP is higher, and our patient compliance rate should improve on a go-forward basis. And you see it in other ways, you see things like our DSO improvement improved by 15 days year-on-year. So all that team has made done a really good job at enhancing our overall kind of billing systems in the processes.

所以它現在是一個很好的指導，我們的每次測試或 ASP 的收入更高，我們的患者依從率應該在前進的基礎上提高。你會以其他方式看到它，你會看到我們的 DSO 改進比去年同期提高了 15 天。因此，該團隊在增強流程中的整體計費系統方面做得非常好。

On a run-rate basis, ASP for Cologuard, the right way to think of this is around $480 of revenue per test. There are some puts and takes there. And obviously, you've got this newer age group 45 to 49. For a while, that was -- it carried a lower revenue per test as we built up the insurance coverage. There's also some other classes like Medicaid that rightly so come in about 80% of the [Medicaid] often times. But again, to hear the team has done a nice job. And longer term, I think we can work that rate towards $500.

在運行率的基礎上，Cologuard 的 ASP，正確的思考方式是每次測試的收入約為 480 美元。那裡有一些投入和投入。很明顯，你有 45 到 49 歲這個較新的年齡組。有一段時間，隨著我們建立保險範圍，它每次測試的收入較低。還有一些其他類別，如醫療補助計劃，經常出現在 [醫療補助計劃] 的 80% 左右。但是，再次聽到團隊做得很好。從長遠來看，我認為我們可以將該利率提高到 500 美元。

Your final question comes from the line of Dan Leonard from Crédit Suisse.

你的最後一個問題來自 Crédit Suisse 的 Dan Leonard。

So I have a question on your Precision Oncology guide. It doesn't seem like you're expecting much from OncoExTra. Is that accurate? And could you walk through the past for some of these new products like OncoExTra and MRD to contribute to the sales ramp in Precision Oncology?

所以我對您的精準腫瘤學指南有疑問。看起來您對 OncoExTra 的期望並不高。那是準確的嗎？您能否回顧一下這些新產品（如 OncoExTra 和 MRD）的過去，從而為精準腫瘤學的銷售增長做出貢獻？

I can start and maybe Everett can jump in. So what's baked in the PO guide globally, U.S. and we've been talking about this for a long time, given the strong current market position, as a class, the penetration rate there is over 70%. We do a nice job within that. Given the strong position, the growth in the U.S. for the Oncotype DX business, I think of low single digits. This is prevalent plus maybe a point.

我可以開始，也許 Everett 可以加入。那麼全球採購指南中的內容，美國，我們已經討論了很長時間，鑑於目前強大的市場地位，作為一個類別，那裡的滲透率已經結束70%。我們在這方面做得很好。鑑於強勢地位，Oncotype DX 業務在美國的增長，我認為是低個位數。這很普遍，也許還有一點。

Now the strength of that foundation will allow us to launch other programs like OncoExTra, like MRD, like the Riskguard, which is the hereditary cancer product. Internationally, the growth there is that business think of kind of $150 million a year right now. Growth there over time should be double digits for many years to come.

現在，該基金會的實力將使我們能夠推出其他項目，如 OncoExTra、MRD、Riskguard，這是一種遺傳性癌症產品。在國際上，那裡的增長是企業現在每年想到的 1.5 億美元。隨著時間的推移，那裡的增長在未來許多年裡應該是兩位數。

Year-to-year, it can be a little different depending on which markets opened up that year. This year, the big new market that we expect to come online is Japan midyear. So what's baked in is stronger growth in the U.S., but it's not that we won't get the full year impact from Japan.

年復一年，可能會有所不同，具體取決於當年開放的市場。今年，我們預計上線的新大市場是日本年中。因此，美國的增長勢頭強勁，但這並不是說我們不會從日本那裡獲得全年的影響。

So it's not strong double-digit growth this year. It's probably high single or low double-digit baked in. OncoExTra, there, I think it's considered north of $10 million of revenue this year. It is the first year of launch. I know that Everett and the team are excited about the launch, but it's early. So we'll come back to you and look forward to providing an update as you unfold there.

所以今年的兩位數增長並不強勁。它可能是高個位數或低兩位數。OncoExTra，在那裡，我認為它今年的收入超過 1000 萬美元。這是推出的第一年。我知道 Everett 和團隊對發布感到興奮，但現在還為時過早。因此，我們會回來找您，並期待在您在那裡展開時提供更新。

Yes, I'll just add. We often talk about the productivity of our Cologuard sales and marketing team. My hats off to our Precision Oncology sales and marketing team. We had the launch of OncoExTra a couple of weeks ago. The training team and marketing team did a great job of preparing our sales organization to launch it day 1.

是的，我只是補充一下。我們經常談論我們 Cologuard 銷售和營銷團隊的生產力。我向我們的 Precision Oncology 銷售和營銷團隊致敬。幾週前我們推出了 OncoExTra。培訓團隊和營銷團隊為我們的銷售組織做好了第一天推出的準備工作。

And again, the granularity of who we're focused on, on who we need to drive OncoExTra was really evident at our sales and market -- at our launch of OncoExTra, and we're already generating orders. So as Jeff said, we're going to look to hit, beat our target for OncoExTra in 2023.

再一次，我們關注的對象，我們需要推動 OncoExTra 的人的粒度在我們的銷售和市場上非常明顯——在我們推出 OncoExTra 時，我們已經在生成訂單。正如 Jeff 所說，我們將在 2023 年實現 OncoExTra 的目標。

Yes. And just to understand the differentiation of OncoExTra, this is an enhanced version of a therapy selection test, which is an ultra-comprehensive panel. It includes DNA and RNA. It detects the clinically actionable mutations infusions, including whole exome, whole transcriptome sequencing. It also includes patient matched tumor-normal sequencing, and it has an incredibly easy to interpret result -- reports for FDA-approved therapies, immuno-oncology signatures, et cetera.

是的。只是為了了解 OncoExTra 的差異化，這是一種治療選擇測試的增強版，它是一個超全面的面板。它包括DNA和RNA。它檢測臨床上可操作的突變輸入，包括全外顯子組、全轉錄組測序。它還包括患者匹配的腫瘤-正常測序，並且它具有非常容易解釋的結果——FDA 批准的治療報告、免疫腫瘤學特徵等。

And then one thing, Dan, you didn't ask this question, but I don't think we touched upon was around the follow-up colonoscopy approval changes. Everett, maybe you want to just touch on that?

然後一件事，丹，你沒有問這個問題，但我認為我們沒有談到後續結腸鏡檢查批准的變化。埃弗里特，也許你想談談這個？

Absolutely. Thanks, Kevin. One of the biggest objections from our customers around Cologuard was, hey, if they get a positive Cologuard test, that patient is burdened with paying for the follow-up colonoscopy. CMS and commercial last year made the positive development that there will be no co-pay, 0 co-pay for follow-up coloscopy.

絕對地。謝謝，凱文。我們 Cologuard 周圍的客戶最大的反對意見之一是，嘿，如果他們的 Cologuard 測試呈陽性，那麼該患者將承擔後續結腸鏡檢查的費用。 CMS 和 commercial 去年取得了積極的發展，即沒有共付額，後續結腸鏡檢查的共付額為 0。

Our organization is now focused on getting that message out. It takes time. We had to educate over 300,000 primary care physicians and health systems on that new ruling. But we're really excited about that new development legislation, and we're out every day talking about the positive development.

我們的組織現在專注於傳達這一信息。這需要時間。我們必須對超過 300,000 名初級保健醫生和衛生系統進行有關該新規定的教育。但我們對新的發展立法感到非常興奮，我們每天都在談論積極的發展。

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

這確實結束了今天的電話會議。感謝您的參與。您現在可以斷開連接。