Exact Sciences Corp (EXAS) 2023 Q4 法說會逐字稿

Good afternoon, and welcome to the Exact Sciences Fourth Quarter 2023 Earnings Call. Please be advised that this call will be recorded. (Operator Instructions) I would now like to turn the conference over to Mr. Nate Harrill, Vice President of Investor Relations. You may begin your conference.

下午好，歡迎參加 Exact Sciences 2023 年第四季財報電話會議。請注意，此通話將會被錄音。 （操作員指示）我現在將會議交給投資者關係副總裁 Nate Harrill 先生。您可以開始您的會議了。

Thanks, Jeanie. Thank you for joining us for Exact Sciences' Fourth Quarter 2023 Conference Call. On the call today are Kevin Conroy, the company's Chairman and CEO; and Jeff Elliott, our Chief Financial Officer. Everett Cunningham, our Chief Commercial Officer; and Brian Baranick, our General Manager of Precision Oncology will also be available for questions.

謝謝，珍妮。感謝您參加 Exact Sciences 2023 年第四季電話會議。今天參加電話會議的是該公司董事長兼執行長凱文康羅伊 (Kevin Conroy)；和我們的財務長 Jeff Elliott。 Everett Cunningham，我們的商務長；我們的精準腫瘤學總經理 Brian Baranick 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. During today's call, we will make forward-looking statements based on current expectations. Our actual results may be materially different 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.

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表現。本新聞稿和今天的演示可在我們的網站 exactsciences.com 上取得。在今天的電話會議中，我們將根據當前預期做出前瞻性陳述。我們的實際結果可能與此類聲明有重大差異。我們的收益新聞稿中提供了對非 GAAP 數據的討論以及與 GAAP 數據的調節，並且與 Exact Sciences 相關的風險和不確定性的描述包含在我們向 SEC 提交的文件中。

Both can be accessed through our website. I'll now turn the call over to Kevin.

兩者都可以透過我們的網站存取。我現在將電話轉給凱文。

Thanks, Nate. 2023 was another record-breaking year for Exact Sciences, and our fourth quarter results set the tone for an impactful year ahead. A special thanks to our team for testing a record number of people during the quarter with our established brands, Cologuard, Oncotype DX and PreventionGenetics.

謝謝，內特。 2023 年是 Exact Sciences 又一個破紀錄的一年，我們第四季的業績為未來具有影響力的一年定下了基調。特別感謝我們的團隊在本季使用我們的知名品牌 Cologuard、Oncotype DX 和 PreventionGenetics 測試了創紀錄的人數。

We've built an unrivaled platform that will allow us to achieve our purpose to help eradicate cancer. We're hosting today's call from our San Diego R&D center. Our talented scientists are harnessing the power of DNA, RNA and proteins. They're developing a range of new tests that will change how cancer is diagnosed and treated. We're set to gain momentum as we bring these new tests to physicians and patients at regular intervals over the next few years.

我們建立了一個無與倫比的平台，使我們能夠實現幫助根除癌症的目標。我們在聖地牙哥研發中心主持了今天的電話會議。我們才華橫溢的科學家正在利用 DNA、RNA 和蛋白質的力量。他們正在開發一系列新的測試，這將改變癌症的診斷和治療方式。隨著我們在未來幾年定期向醫生和患者提供這些新測試，我們將獲得動力。

Highlights in 2023 include testing a record 4.1 million patients for cancer and rare diseases, growing core revenue by 24% to $2.5 billion. Improving adjusted EBITDA of $362 million year-over-year, turning free cash flow positive, submitting next-generation Cologuard for FDA approval. Launching Oncotype DX in Japan on a reimbursed basis, accelerating our molecular residual disease or MRD program, launching OncoExTra, our solid tumor therapy selection test and adding OncoLiquid, our liquid therapy selection test and advancing our multi-cancer early detection.

2023 年的亮點包括對 410 萬名癌症和罕見疾病患者進行創紀錄的檢測，核心收入成長 24% 至 25 億美元。調整後 EBITDA 年增 3.62 億美元，自由現金流轉為正數，並將新一代 Cologuard 提交 FDA 批准。在日本以報銷方式推出 Oncotype DX，加速我們的分子殘留病或 MRD 計劃，推出我們的實體瘤治療選擇測試 OncoExTra，並添加我們的液體治療選擇測試 OncoLiquid，並推進我們的多癌症早期檢測。

The Exact Sciences team is laser focused on 5 things this year. further embedding Cologuard a standard of care, increasing Oncotype DX adoption internationally, advancing key pipeline programs deepening relationships with health systems and delivering experiences that patients and providers love.

Exact Sciences 團隊今年專注於 5 件事。進一步將 Cologuard 納入護理標準，提高 Oncotype DX 在國際上的採用率，推進關鍵管道項目，加深與健康系統的關係，並提供患者和提供者喜愛的體驗。

Jeff will now focus on our financial results and our outlook for 2024.

Jeff 現在將專注於我們的財務表現和 2024 年的展望。

Thanks, Kevin. Fourth quarter revenue of $647 million grew 17% or 18% on a core basis, excluding COVID testing, FX and M&A. Screening revenue of $487 million increased 21%. We continue to see broad-based momentum in Cologuard adoption by health care providers with an all-time high 172,000 ordering Cologuard during the quarter.

謝謝，凱文。第四季營收為 6.47 億美元，核心營收成長 17% 或 18%（不包括新冠病毒測試、外匯和併購）。放映收入達 4.87 億美元，成長 21%。我們繼續看到醫療保健提供者採用 Cologuard 的廣泛勢頭，本季訂購 Cologuard 的人數達到歷史最高水準 172,000 人。

This expanding base of order providers supports our long-term growth outlook. Precision Oncology revenue of $160 million grew 12% or 11% on a core basis. Growth was led by Oncotype DX, which expanded 48% internationally. Fourth quarter GAAP gross margin was 70%. Non-GAAP gross margin, excluding amortization of acquired intangibles, was 73%. Net loss was $50 million, and adjusted EBITDA was $50 million, an improvement of $45 million driven by better-than-expected revenue and continued operating expense discipline. Free cash flow was $35 million, an improvement of $55 million. We ended the year with cash and securities of $778 million.

不斷擴大的訂單提供者基礎支持了我們的長期成長前景。精準腫瘤學收入為 1.6 億美元，核心收入成長 12% 或 11%。 Oncotype DX 引領成長，其國際業務擴張了 48%。第四季 GAAP 毛利率為 70%。非公認會計準則毛利率（不包括收購的無形資產攤銷）為 73%。淨虧損為 5,000 萬美元，調整後 EBITDA 為 5,000 萬美元，由於收入優於預期和持續嚴格的營運費用控制，淨虧損增加了 4,500 萬美元。自由現金流為 3500 萬美元，增加了 5500 萬美元。年底，我們擁有 7.78 億美元的現金和證券。

Turning to guidance, we expect total revenue between $615 million and $630 million for the first quarter and between $2.81 billion and $2.85 billion for the year. This assumes screening revenue between $460 million and $470 million for the first quarter and between $2.155 billion and $2.175 billion for the year and Precision Oncology revenue between $155 million and $160 million for the first quarter and between $655 million and $675 million for the year.

至於指引，我們預計第一季總收入將在 6.15 億美元至 6.3 億美元之間，全年總收入將在 28.1 億美元至 28.5 億美元之間。假設第一季的篩檢收入在4.6 億美元至4.7 億美元之間，全年的篩檢收入在21.55 億美元至21.75 億美元之間，精準腫瘤學第一季的營收在1.55 億美元至1.6億美元之間，全年的營收在6.55 億美元至6.75 億美元之間。

Annual guidance implies 13% core revenue growth, with 16% growth in screening and 6% growth in Precision Oncology. We expect to generate between $325 million and $350 million of adjusted EBITDA for the year. We also expect CapEx to be around $150 million. We expect first quarter screening revenue to be down sequentially because of typical seasonal trends. Primary care utilization is lower in December and early January because of the holidays. This impacts screening revenue during the first quarter due to the normal timing between a Cologuard order and a completed test.

年度指引意味著核心收入成長 13%，其中篩檢成長 16%，精準腫瘤學成長 6%。我們預計今年調整後的 EBITDA 將達到 3.25 億至 3.5 億美元。我們也預計資本支出約為 1.5 億美元。由於典型的季節性趨勢，我們預計第一季的放映收入將季減。由於假期，12 月和 1 月初初級保健利用率較低。由於 Cologuard 訂單和完成測試之間的正常時間安排，這會影響第一季的篩檢收入。

We expect first quarter screening to be about 22% of full year revenue, consistent with the historical average.

我們預計第一季放映收入將佔全年收入的 22% 左右，與歷史平均值一致。

In Precision Oncology, we expect steady Oncotype DX growth in the U.S. and strong double-digit growth internationally this year. Exact Sciences acts as a reference lab and processes test for other lab customers. Starting in the first quarter, we're assuming a $20 million headwind or 3 points of revenue growth for Precision Oncology as various agreements related to whole exome sequencing and prostate cancer testing are transitioned in-house by those ordering labs.

在精準腫瘤學領域，我們預計 Oncotype DX 今年將在美國穩定成長，並在國際上實現兩位數的強勁成長。 Exact Sciences 充當參考實驗室，並為其他實驗室客戶進行測試。從第一季開始，我們假設精準腫瘤學將面臨 2000 萬美元的逆風或收入增長 3 個百分點，因為與全外顯子組測序和前列腺癌檢測相關的各種協議由訂購實驗室在內部轉移。

The team did a great job implementing automation within our state-of-the-art labs, which will drive gross margin expansion this year and beyond. We're also expecting continued OpEx leverage this year, especially within G&A. Sustainable double-digit revenue growth and industry-leading gross margins are powering adjusted EBITDA and free cash flow as we continue investing in growth and efficiencies.

該團隊在我們最先進的實驗室內實施自動化方面做得非常出色，這將推動今年及以後的毛利率擴張。我們也預期今年營運支出槓桿率將持續上升，尤其是在一般管理費用方面。隨著我們繼續投資於成長和效率，可持續的兩位數收入成長和行業領先的毛利率正在推動調整後的 EBITDA 和自由現金流。

Priority areas of investment this year include reaching more people through new digital and TV advertisement campaigns for Cologuard, further improving the patient and physician experience through our technology platform and advancing our MRD program. Back to you, Kevin.

今年的優先投資領域包括透過 Cologuard 的新數位和電視廣告活動吸引更多人，透過我們的技術平台進一步改善患者和醫生的體驗以及推進我們的 MRD 計劃。回到你身上，凱文。

Thanks, Jeff. Brand awareness and loyalty are fueling Cologuard adoption and helping reach 60 million Americans who are not up to date with colon cancer screening. The number of health care providers ordering Cologuard and the number of Cologuard testing order have consistently grown. Cologuard is an essential part of their screening tool kit in part because patients prefer it and ask for it.

謝謝，傑夫。品牌知名度和忠誠度正在推動 Cologuard 的採用，並幫助涵蓋 6000 萬未及時進行大腸癌篩檢的美國人。訂購 Cologuard 的醫療保健提供者數量和 Cologuard 測試訂單數量持續成長。 Cologuard 是他們篩檢工具包的重要組成部分，部分原因是患者喜歡它並要求它。

During the fourth quarter, Cologuard brand awareness reached 89%, an all-time high, and our market research showed people who have never been screened prefer Cologuard 2 to 1 for their colonoscopy. We're building on this momentum by helping health systems achieve positive clinical and financial outcomes, designing innovative ways to get more patients rescreened and partnering with federally qualified health centers and health care providers that serve diverse units.

第四季度，Cologuard 品牌知名度達到 89%，創歷史新高，我們的市場研究顯示，從未接受過篩檢的人更喜歡使用 Cologuard 2 比 1 進行大腸鏡檢查。我們正在利用這一勢頭，幫助衛生系統取得積極的臨床和財務成果，設計創新方法讓更多患者接受重新篩檢，並與聯邦合格的衛生中心和為不同單位提供服務的衛生保健提供者合作。

Our Precision Oncology team has guided treatment decisions for more than 2 million cancer patients around the world including a record 230,000 last year. Oncotype DX recently celebrated its 20th anniversary. During those years, Oncotype DX has become the global standard of care for patients diagnosed with early-stage HR-positive HER2-negative breast cancer, the most common subtype. We've received Oncotype DX orders from more than 120 countries and 98% of U.S. oncologists have ordered. Oncotype DX has helped spare over 1.3 million patients from unnecessary chemotherapy.

我們的精準腫瘤學團隊已為全球超過 200 萬名癌症患者指導了治療決策，其中去年的患者人數達到創紀錄的 23 萬人。 Oncotype DX 最近慶祝了其成立 20 週年。在那些年裡，Oncotype DX 已成為診斷為早期 HR 陽性 HER2 陰性乳癌（最常見的亞型）患者的全球照護標準。我們已收到來自 120 多個國家的 Oncotype DX 訂單，其中 98% 的美國腫瘤科醫生已訂購。 Oncotype DX 已幫助超過 130 萬名患者免於不必要的化療。

Increased international adoption led by Japan will be a key growth driver in Precision Oncology this year. We also plan to move our Precision Oncology portfolio onto our proprietary IT platform, making prior authorizations, billing and reimbursement highly efficient. This will also enable rapid scaling of future tests, including OncoDetect, our MRD test and [OncoLiquid], our blood-based therapy selection test. We are using our deep scientific capabilities and regulatory expertise to advance impactful pipeline programs, including multiple home cancer screening initiatives and MRD.

以日本為首的國際採用率的提高將成為今年精準腫瘤學的主要成長動力。我們還計劃將我們的精準腫瘤學產品組合轉移到我們專有的 IT 平台上，從而使事先授權、計費和報銷變得高效。這也將使未來測試的快速擴展成為可能，包括 OncoDetect、我們的 MRD 測試和 [OncoLiquid]、我們的基於血液的治療選擇測試。我們正在利用深厚的科學能力和監管專業知識來推進有影響力的管道計劃，包括多項家庭癌症篩檢計劃和 MRD。

In colon cancer screening, we shared data from the prospective BLUE-C study demonstrating next-generation Cologuard will raise the performance bar in noninvasive screening. We submitted our premarket approval application to the FDA in December and expect to make the test available to patients in 2025. Most BLUE-C study participants also provided a sample for evaluating our novel blood-based colon cancer screening test. This year, we plan to announce top line results from BLUE-C for our colon cancer blood test.

在大腸癌篩檢中，我們分享了前瞻性 BLUE-C 研究的數據，證明下一代 Cologuard 將提高非侵入性篩檢的表現標準。我們在 12 月向 FDA 提交了上市前批准申請，預計在 2025 年向患者提供該測試。大多數 BLUE-C 研究參與者還提供了樣本來評估我們新型基於血液的結腸癌篩檢測試。今年，我們計劃公佈 BLUE-C 結腸癌血液檢測的主要結果。

In MRD, we plan on sharing several sets of data this year, including evidence that will support reimbursement in colon cancer. We're excited about the performance of OncoDetect and look forward to integrating it into the powerful technology we licensed from the Broad Institute. Our mission is to help eradicate cancer by preventing it, detecting it earlier and guiding personalized treatment.

在 MRD 中，我們計劃今年共享幾組數據，包括支持結腸癌報銷的證據。我們對 OncoDetect 的性能感到興奮，並期待將其整合到我們從 Broad Institute 獲得許可的強大技術中。我們的使命是透過預防、早期檢測和指導個人化治療來幫助根除癌症。

Our unique platform deeply embedded standard of care test and pipeline of life-changing diagnostics will power years of growth and continued profitability, helping us achieve our mission. We're now happy to take your questions.

我們獨特的平台深深嵌入護理測試標準和改變生活的診斷管道，將為多年的成長和持續盈利提供動力，幫助我們實現我們的使命。我們現在很樂意回答您的問題。

(Operator Instructions) Your first question comes from the line of Brandon Couillard with Jefferies.

（操作員說明）您的第一個問題來自 Brandon Couillard 和 Jefferies 的線路。

Two-parter for Jeff. First, on the first quarter revenue guide, can you just unpack the $20 million headwind, I think, in the Precision Oncology business that you referenced a little more detail on that? And then secondly, as you think about the guide for '24, what are you penciling in for OpEx and gross margins for the year?

傑夫的兩人合作。首先，關於第一季的收入指南，我想，您能否解釋一下精密腫瘤學業務中 2000 萬美元的逆風，您對此提到了更多細節？其次，當您考慮 24 年的指南時，您對今年的營運支出和毛利率有何預期？

Sure. On the $20 million, this is an annual impact. Like I said, we, Exact acts as the reference lab for others in the space. And some of those contracts were not surprised by some of these are rolling off as those labs take that work in-house. So that's over the year, expected to be a $20 million headwind, probably hurts Q1 a bit more than Q4, but that's the annual impact.

當然。就 2000 萬美元而言，這是每年的影響。就像我說的，我們 Exact 充當該領域其他人的參考實驗室。其中一些合約對於其中一些合約的簽訂並不感到驚訝，因為這些實驗室在內部進行了這項工作。因此，全年預計將帶來 2000 萬美元的逆風，對第一季的影響可能比第四季更大，但這就是年度影響。

On what -- the true growth drivers for appetite over time are going to be continued uptake in the node positive indication. International, which in an awesome quarter in Q4, grew 48%. And then over time, this serves as a perfect foundation for new product launches like MRD and therapy selection. So the business is very healthy. We have a comparison item this year.

隨著時間的推移，食慾的真正成長動力將是節點積極跡象的持續吸收。國際業務在第四季度表現出色，成長了 48%。隨著時間的推移，這將為 MRD 和治療選擇等新產品的發布奠定完美的基礎。所以生意非常健康。今年我們有一個比較專案。

On the margin side, you've heard me talk for years about gross margin expansion. This year, we expect continued progress. We've put in lab automation. The team did a fabulous job there of automating those labs. Many of you have seen it. If you haven't, you're welcome to come in to our facilities, They are state-of-the-art. Automating those labs further will help -- we expect as we grow this year, leveraging that fixed cost is a big deal.

在利潤率方面，您多年來一直聽我談論毛利率擴張。今年，我們預計將繼續取得進展。我們已經實現了實驗室自動化。團隊在實驗室自動化方面做得非常出色。你們很多人都見過它。如果您還沒有，歡迎您來到我們的設施，它們是最先進的。進一步自動化這些實驗室將有所幫助——我們預計，隨著今年我們的發展，利用固定成本是一件大事。

Broadly speaking, gross margin improvement. OpEx leverage, another hallmark. We've built a strong foundation. And you've seen the impact over the last couple of years, we've had significant adjusted EBITDA and leverage. We expect that to continue again. Probably the highlight this year will be within G&A. I expect that to be our biggest source of leverage. However, I do expect leverage across all 3 lines, G&A, sales and marketing and R&D.

整體而言，毛利率有所改善。營運支出槓桿是另一個標誌。我們已經建立了堅實的基礎。您已經看到了過去幾年的影響，我們對 EBITDA 和槓桿率進行了重大調整。我們預計這種情況將再次持續下去。今年的亮點可能是 G&A。我預計這將成為我們最大的槓桿來源。然而，我確實期望在所有 3 個業務中發揮槓桿作用，即一般管理費用、銷售和行銷以及研發。

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

你的下一個問題來自凱瑟琳舒爾特和貝爾德的對話。

Have a two-parter for you. Maybe first on the screening guide, you've been clear in the past to expect 1Q to be down sequentially. But can you just talk through phasing for the rest of the year and what gives you confidence in the ramp there? And then second, Kevin, I know you have a fairly big chunk of options that are expiring, I believe, later this week. Any comments on what you're planning to do with those?

為您安排一個二人組。也許首先在篩選指南中，您過去已經明確預計第一季會連續下降。但您能談談今年剩餘時間的分階段發展嗎？是什麼讓您對那裡的成長充滿信心？其次，凱文，我知道你有相當多的期權將在本週晚些時候到期。對於你打算用這些做什麼有什麼評論嗎？

Let me start with the second first. Yes, I have options that are expiring their 10-year grants. So they were granted in 2014. And I plan to exercise and hold while selling just enough to pay the cost of exercising and the taxes. But the goal is to hold the difference.

讓我先從第二個開始。是的，我有一些選擇權，他們的 10 年期補助金即將到期。所以它們在 2014 年獲得了批准。我計劃行使並持有，同時出售足夠支付行使成本和稅收的資金。但目標是保持差距。

And I will just say before handing it over to Jeff, We came off a great year in 2024. The momentum is something that is generating enthusiasm across internally and also our important customer and patient base that we take care of, there's still 60 million people out there still this year, like there was last year that are not up to date with screening. And we have a huge opportunity there, and we're making incredible progress with health systems, payers, the brand awareness of Cologuard. It's an exciting time with Precision Oncology continued growth and node positive internationally and then just a number of new product launches over the next 2 years. So we couldn't be more excited. Jeff, why don't you take the rest?

在將其交給傑夫之前，我只想說，我們在 2024 年度過了美好的一年。這種勢頭在內部以及我們所照顧的重要客戶和患者群體中產生了熱情，仍然有 6000 萬人今年仍然存在，就像去年一樣，沒有及時進行篩檢。我們在那裡擁有巨大的機會，我們在衛生系統、付款人和 Cologuard 的品牌知名度方面正在取得令人難以置信的進步。這是一個令人興奮的時刻，精準腫瘤學持續成長並在國際上取得積極進展，並且在未來兩年內將推出一些新產品。所以我們非常興奮。傑夫，為什麼不把剩下的拿走呢？

Sure. Catherine, on your phasing question, we've talked about this many times before, but as a reminder, primary care utilization typically impacted around the holidays. So basically, we lose about 2 weeks of the quarter, around Christmas and New Years, 2 weeks for patients and physicians take off, go on vacation. So that's the fact that there's fewer office visits during that time.

當然。凱瑟琳，關於你的分階段問題，我們之前已經多次討論過這個問題，但提醒一下，初級保健的利用通常會在假期前後受到影響。所以基本上，我們在這個季度損失了大約 2 週的時間，即聖誕節和新年前後，這 2 週的時間供患者和醫生休假、休假。這就是事實，在那段時間裡去辦公室的次數減少了。

I mean, there's fewer Cologuard orders that. That means about 30 days later, when we complete that test, that's less revenue we recognize. So the holidays really impact Q1, so I would continue to expect a sequential step down Q4 to Q1, as you model out forever. Think of our screening business down sequentially. This is very similar to what you see in Precision Oncology. The Oncotype brand continues to grow, but you do see that step down. It's related to physician office visits around Christmas and New Years are slower which hurts Q1 revenue.

我的意思是，Cologuard 的訂單越來越少。這意味著大約 30 天后，當我們完成測試時，我們確認的收入會減少。因此，假期確實會影響第一季度，因此我將繼續預計第四季度到第一季將連續下降，因為您將永遠模型化。想想我們的篩選業務按順序下降。這與您在精準腫瘤學中看到的非常相似。 Oncotype 品牌繼續成長，但您確實看到了這種下降。這與聖誕節和新年期間醫生就診速度較慢有關，這損害了第一季的收入。

So from a phasing standpoint, typically, we expect pretty strong growth in orders for Cologuard throughout the early part of the year up into May. Things typically flatten out over the summer months and then steep ramp again from Labor Day through Thanksgiving. That's what we expect this year.

因此，從分階段的角度來看，我們通常會預期 Cologuard 的訂單從今年年初到 5 月將出現相當強勁的成長。夏季月份情況通常會趨於平穩，然後從勞動節到感恩節再次急劇上升。這就是我們今年的預期。

From a revenue standpoint, I would -- again, I said in my remarks, 22% of Q1 revenue for screening in -- this year. That's consistent with the historical average. When you look at a growth standpoint, from a growth standpoint, we're expecting 23% on a 2-year stack basis, so a 2-year compounded growth in Q1. So as Kevin said, very strong trends here, you just have a phase-in dynamic in Q1 to keep in mind.

從收入的角度來看，我在發言中再次表示，今年將第一季營收的 22% 用於放映。這與歷史平均一致。從成長的角度來看，我們預計 2 年堆疊成長 23%，因此第一季將實現 2 年複合成長。因此，正如凱文所說，這裡的趨勢非常強勁，您只需記住第一季的分階段動態即可。

Your next question comes from the line of Doug Schenkel with Wolfe Research.

您的下一個問題來自 Wolfe Research 的 Doug Schenkel。

My first one is just a guidance clarification question. I think you guided to 16% screening revenue growth for the year, as I think you talked about back in January. Just keeping in mind a bigger opportunity for repeat orders this year, which I think -- I don't have my model in front of me, but I think could be between 250,000 to 300,000 tests. What does this imply for first-time orders in terms of the growth there? It seems like it's a moderation there. And if that's the case, I just want to make sure that, that is conservatism versus anything else.

我的第一個問題只是一個指導性澄清問題。我認為您指導今年的放映收入成長 16%，正如您在一月份談到的那樣。請記住，今年重複訂單的機會更大，我認為 - 我面前沒有我的模型，但我認為可能會進行 250,000 到 300,000 次測試。這對於首次訂單的成長意味著什麼？看來那裡有節制。如果是這樣的話，我只是想確定一下，這就是保守主義與其他任何東西的區別。

And then my second question is just a competition question. Obviously, some big readouts expected from blood-based competition coming up soon. As we head into that, I'm wondering if you'd be willing to share what you think the bar should be as we look at key data like advanced adenoma detection as those readouts come in.

然後我的第二個問題只是一個競賽問題。顯然，基於血液的競爭預計很快就會出現一些重大讀數。當我們進入這個主題時，我想知道您是否願意分享您認為的標準應該是什麼，因為我們會在這些讀數出現時查看高級腺瘤檢測等關鍵數據。

This is Jeff. I'll take the first one on screening. So yes, we did guide to 16% growth for the year coming off of a year, just a tremendous year in '23. Kevin talked about some of the highlights there we're comping against 31% growth. So 60% feel good about that, and there's a long runway ahead here. One of the slides we shared today showed the broadening of the ordering base and the deepening of the ordering base.

這是傑夫。我將在篩選時選擇第一個。所以，是的，我們確實指導了 2013 年的 16% 成長，這只是 23 年的偉大一年。 Kevin 談到了我們與 31% 的成長相比的一些亮點。 60% 的人對此感覺良好，而且前面還有很長的路要走。我們今天分享的一張幻燈片顯示了訂購基礎的擴大和訂購基礎的深化。

This has continued for 9 years, and we expect that to grow for many years to come. Rescreens this year to frame this last year rescreen, a 3-year repeat customer was about 20% of screening revenue. This year, it's going to be called a couple of points higher. So it is growing rapidly. It is one of our biggest growth drivers. The reason why it's growing really twofold. One is that the pool of new patients becoming eligible accelerates this year, it's up to $1.6 million. It was that 1.2 million new patients becoming eligible for the last couple of years.

這種情況已經持續了 9 年，我們預計這種情況將持續成長多年。今年的重新篩選是為了框架去年的重新篩選，3 年回頭客約佔篩選收入的 20%。今年，它將被稱為更高幾個百分點。所以它正在快速成長。這是我們最大的成長動力之一。它成長的原因確實是雙重的。一是今年符合資格的新患者數量不斷增加，達到 160 萬美元。過去幾年，有 120 萬名新患者符合資格。

And also, our success rate at getting those people back to Cologuard continues to grow. The team has did a nice job executing there. What this implies for first-time users, we typically think of that age 50-plus first-time users. Is still double-digit growth. That's one of the beauties of this business model, is that because this is such a massive market, 110 million people in total, you can expect predictable sustainable growth. Double-digit growth from that key ordering group, Doug. And then Everett, do want to add anything to that?

而且，我們讓這些人重返 Cologuard 的成功率也不斷提高。該團隊在那裡執行得很好。這對首次用戶意味著什麼，我們通常會想到 50 歲以上的首次用戶。仍然是兩位數的成長。這是這種商業模式的優點之一，因為這是一個龐大的市場，總共有 1.1 億人，所以你可以期待可預測的可持續成長。關鍵訂購群體 Doug 實現了兩位數的成長。然後埃弗雷特（Everett）想補充什麼嗎？

Yes, Jeff, let me just add a couple of things, Doug. As Jeff said and Kevin said, we're coming off an incredible year in '23. I've recently just participated in our global sales meeting and I'm just telling you our -- to ahead, everybody feels that we have an incredible opportunity to continue this growth to fulfill our mission. As we've said, Cologuard has grown by 31% last year.

是的，傑夫，讓我補充幾件事，道格。正如 Jeff 和 Kevin 所說，我們將在 23 年度過令人難以置信的一年。我最近剛參加了我們的全球銷售會議，我只是告訴你們，展望未來，每個人都覺得我們有一個難以置信的機會來繼續這種成長，以完成我們的使命。正如我們所說，Cologuard 去年成長了 31%。

And the one thing that we're continuing to do is to smartly invest in areas where we know we can grow profitably. We're looking at our core business, our sales leaders, our end marketing leaders, who're understanding the trade-off between investments and growth. And a couple of things that I feel really, really confident about is how we're getting at this. Marketing, as an example, we're being very smart at the way we're taking advantage of key growth levers like rescreens, our 45 to 49 segment, which is fantastic, opportunities for growth.

我們繼續做的一件事就是明智地投資於我們知道可以獲利成長的領域。我們正在關注我們的核心業務、我們的銷售領導者、我們的終端行銷領導者，他們了解投資和成長之間的權衡。我感到非常非常有信心的幾件事是我們如何實現這一目標。以行銷為例，我們非常聰明地利用了關鍵成長槓桿，例如重新篩選、我們的 45 至 49 歲細分市場，這是一個非常棒的成長機會。

And then secondly, in sales, we are investing wisely in areas that we know we could put additional heads in the marketplace to talk to the right customer at the right time with the right message. We're going to continue to do that. So 2024 can be another incredible year.

其次，在銷售方面，我們正在明智地投資於我們知道可以在市場上投入更多人員的領域，以便在正確的時間與正確的客戶交談，傳達正確的訊息。我們將繼續這樣做。因此，2024 年可能又是令人難以置信的一年。

The second question, Doug, on competition blood tests, what's the bar? I mean first, just reiterate what Everett said, like this is never a straight line. We're always sober there are always opportunities for improvement. That has been every quarter since we launched Cologuard almost 10 years ago, and it's going to be every quarter this year and next year and beyond.

第二個問題，道格，關於比賽血液測試，門檻是什麼？我的意思是，首先，重申埃弗里特所說的話，就像這從來都不是一條直線。我們始終保持清醒，總有改進的機會。自從我們近 10 年前推出 Cologuard 以來，每個季度都是如此，今年、明年及以後的每個季度都會如此。

But the team is focused and we're really excited about the path ahead. In terms of blood tests, we talked about this many times, so I'm not going to add a lot here. The final arbiter of whether a blood test would be widely adopted is the main guideline group USPSTF. They do sophisticated modeling. Their modeling nets out at 2 key factors. One is life years gained, 83% of life years gained in their model comes from precancer detection.

但團隊很專注，我們對未來的道路感到非常興奮。關於血液檢查，我們已經討論過很多次了，所以我不會在這裡補充太多。血液檢測是否會被廣泛採用的最終仲裁者是主要指導小組 USPSTF。他們進行複雜的建模。他們的模型得出了兩個關鍵因素。一是獲得的生命年，在他們的模型中獲得的生命年的 83% 來自癌前檢測。

And then the second factor comes from -- it is the question of unnecessary colonoscopies generated per 1,000 people screened. And what you see there is that, that model is the bar, not anything we believe, it's very objective. And it's very difficult to get into the guidelines with the performance characteristics of what we see today in this category of tests.

第二個因素來自——每 1000 名接受篩檢的人中產生不必要的大腸鏡檢查的問題。你看到的是，那個模型就是標準，而不是我們所相信的任何東西，它非常客觀。而且很難根據我們今天在此類測試中看到的性能特徵來了解指南。

So I think you really do the digging into the USPSTF guidelines, Anybody investing, anybody study in this space, that's where all roads lead to long-term top commercial traction and impact.

所以我認為你確實深入研究了 USPSTF 指南，任何人在這個領域投資、任何人研究，這就是所有道路通往長期頂級商業牽引力和影響力的地方。

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

你的下一個問題來自 Dan Brennan 和 Cowen 的對話。

Great. Maybe first one would just be on 45 to 49 Everett, you mentioned it. Just wondering where that finished up for the year and what you guys are baking in for further traction in '24.

偉大的。也許第一個就在 45 到 49 Everett，你有提到過。只是想知道這一年的結束情況以及你們正在為 24 年的進一步發展做些什麼。

And then, b, Kevin, if I could just go back to the question on blood-based, I appreciate exactly what you said, which is completely fair, but it's hard for us to untangle we'd have to build the model to untangle that what some of us have tried to do. Is there a way to think about just bluntly when that data hits like how -- you've been pretty open about the biological barrier for blood, but I'm just wondering, assuming 90% specificity, where do you still view like the most likely outcome for that data? And is there an upside case that would kind of make you worry?

然後，B，凱文，如果我能回到基於血液的問題，我很欣賞你所說的，這是完全公平的，但我們很難理清思路，我們必須建立模型來理清思路這就是我們中的一些人嘗試做的事情。有沒有一種方法可以直率地思考，當這些數據出現時，你對血液的生物屏障非常開放，但我只是想知道，假設 90% 的特異性，你仍然認為哪裡最像該數據的可能結果？有沒有什麼好的情況會讓您擔心？

Well, so if you take a look at the FIT test, the reason that the FIT test models well is because it detects 24% of precancerous polyps. And it only has a 5% false positive, right? Not a 10% false positive rate like most of the blood tests. You have a 10% false positive rate. As you can imagine, you do that test every year generates twice as many unnecessary colonoscopies as a FIT test. It also -- if a blood test, let's say, it detects in the teens in terms of precancers, you -- it doesn't drive the life years gain.

那麼，如果您看一下 FIT 測試，您會發現 FIT 測試模型良好的原因是它可以檢測到 24% 的癌前息肉。而且它的誤報率只有 5%，對嗎？不像大多數血液檢測有 10% 的假陽性率。您的誤報率為 10%。正如您可以想像的那樣，您每年進行該測試所產生的不必要的大腸鏡檢查數量是 FIT 測試的兩倍。而且，如果血液測試，比方說，它在青少年中檢測出癌症前期，那麼它並不會導致壽命延長。

So you're in this difficult place to get onto this efficient frontier as it's called. So you can do the rough modeling by comparing it to the FIT test. And what you'll see is these blood tests generate a lot of false positives. They also generate not enough life years gained, and the cost of them is significantly more than a FIT test. And certainly, the guideline group considers these broad parameters when they look at including or not including as an A- or B-rated test, it's hard to become an A or B-rated test.

所以你正處於一個困難的境地，要進入這個所謂的高效前沿。因此，您可以透過與 FIT 測試進行比較來進行粗略建模。你會看到這些血液檢查產生了很多誤報。它們還無法獲得足夠的生命年，而且其成本遠高於 FIT 測試。當然，指導小組在考慮是否包含 A 級或 B 級測試時會考慮這些廣泛的參數，因此很難成為 A 級或 B 級測試。

And so I'll go back to the real value that we've created for Cologuard is because we set the bar for the test that we were developing based upon these inputs from the start. That's the way we designed Cologuard, was to make sure that we would be at that efficient frontier of that modeling exercise. And that's why we feel very confident that for years and years to come, colonoscopy and Cologuard will be the two leading tests and you're seeing that today as Cologuard take share away from the FIT test, colonoscopy volume -- screening colonoscopy volumes haven't changed in a meaningful way in a decade.

因此，我將回到我們為 Cologuard 創造的真正價值，因為我們從一開始就根據這些輸入為我們正在開發的測試設定了標準。這就是我們設計 Cologuard 的方式，確保我們處於建模練習的高效前沿。這就是為什麼我們非常有信心，在未來的歲月裡，結腸鏡檢查和Cologuard 將成為兩項領先的測試，您會看到，今天，隨著Cologuard 從FIT 測試中奪走份額，結腸鏡檢查量-篩檢大腸鏡檢查量已經大幅下降。十年間發生了有意義的變化。

Right around 5 million to 6 million screening colonoscopies per year, if not changing now, but backlogs are growing. And so our challenge is to get to the patients. Our challenge is to make this -- to hit the easy one. Our challenge is to make sure that every patient who turns 45 thinks about colon cancer screening and then thinks about Cologuard. And these aren't difficult challenges. And fortunately, we built a team, a technology platform that is built for purpose to achieve our goals.

如果現在不改變的話，每年大約有 500 萬到 600 萬次大腸鏡檢查，但積壓的情況正在增加。因此，我們的挑戰是接觸患者。我們的挑戰是做到這一點——實現簡單的目標。我們面臨的挑戰是確保每位年滿 45 歲的患者先考慮大腸癌篩檢，然後再考慮 Cologuard。這些並不是困難的挑戰。幸運的是，我們建立了一個團隊和一個技術平台，旨在實現我們的目標。

Dan, this is Jeff. On 45 to 49, this is one of the many ways that Exact is competitively unique is that we've had now almost 3 years of working to build awareness and penetrate this younger population. And what that means is it's approaching 20% of our screening revenue today. So it has been a massive growth driver. I expect that to continue when you look at the need here, as Kevin said, there's a relatively limited capacity for colonoscopies in this country. So when you add 20 million more people into the screening pool like the guidelines did 3 years ago, Cologuard is the best option. So we are taking significant share there. it is above growth drive rate above the overall base of business. And I think that will continue for many years to come. Ev anything?

丹，這是傑夫。針對 45 歲至 49 歲的人群，Exact 具有獨特的競爭優勢，其中之一就是我們已經花了近 3 年的時間來努力提高意識並滲透到這一年輕群體中。這意味著它已接近我們今天放映收入的 20%。因此，它是一個巨大的成長動力。我預計，當你看到這裡的需求時，這種情況會持續下去，正如凱文所說，這個國家的大腸鏡檢查能力相對有限。因此，當您像 3 年前的指導方針一樣將 2000 萬人添加到篩檢池中時，Cologuard 是最佳選擇。所以我們在那裡佔據了很大的份額。它高於整體業務基礎的成長驅動率。我認為這種情況將持續很多年。伊芙有什麼嗎？

Yes. I'll add just maybe some field entail around the 45 to 49 segment, Our field organization knows this is a great opportunity to grow Cologuard, and we're helping our customers. I'll give you 2 examples around health systems. There are still some health systems that don't have the new guidelines in their health maintenance systems. And as kind of said, the easy button. We know where these health systems are. So we're targeting these health systems to make sure that they have it in their health maintenance system.

是的。我會補充一些可能涉及 45 至 49 細分市場的領域，我們的現場組織知道這是發展 Cologuard 的絕佳機會，我們正在幫助我們的客戶。我將舉兩個有關衛生系統的例子。仍有一些衛生系統的健康維護系統中沒有新的指引。正如所說，簡單按鈕。我們知道這些衛生系統在哪裡。因此，我們的目標是這些衛生系統，以確保他們將其納入其健康維護系統中。

The second is this is the data that our sales representatives have. Our sales representatives know by individual prescriber which health care providers are ordering Cologuard for the 50-plus audience but are not ordering it for the 45 to 49. So then they will gear their message to making sure that they know the new guidelines to making sure we get our fair share in that younger cohort.

第二個是我們的銷售代表擁有的數據。我們的銷售代表透過個人處方者了解哪些醫療保健提供者正在為50 歲以上的受眾訂購Cologuard，但不會為45 歲至49 歲的受眾訂購。因此，他們將調整他們的訊息，以確保他們了解新指南，以確保我們在年輕群體中得到了公平的份額。

And then lastly, as I mentioned earlier, we have specific marketing campaigns for the younger segment, 45 to 49. We'll continue that in '24.

最後，正如我之前提到的，我們針對 45 歲至 49 歲的年輕族群開展了特定的行銷活動。我們將在 24 年繼續這樣做。

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

您的下一個問題來自 Evercore ISI 的 Vijay Kumar。

I had a two-parter. Kevin, on the life years gain here, I'm just curious with your sensitivity for advanced adenoma being, I think, 43%, 44%. If the blood-based is around 25% or 30%, I'm curious what the life years gain differential would be?

我有一個二人伴侶。凱文，關於這裡的生命年增長，我只是好奇你對晚期腺瘤的敏感性，我認為是 43%、44%。如果血基在25%或30%左右，我很好奇生命年增益差異會是多少？

And Jeff, on adjusted EBITDA margins, it looks like the guide implies 300 basis points expansion year-on-year. That's a little light. I think it implies OpEx showing high singles perhaps, I think when you go back to your longer-term model, maybe there was a little bit more leverage expected. So curious if this is just a conservatism on the OpEx assumptions?

傑夫，就調整後的 EBITDA 利潤率而言，該指南似乎意味著同比擴張 300 個基點。那是一點光。我認為這意味著營運支出可能會顯示出較高的單項成本，我認為當你回到長期模式時，也許預期會有更多的槓桿作用。很好奇這是否只是營運支出假設的保守主義？

So on the first question, you are testing my memory of the ranking. Cologuard has the best ratio of any screening test. Cologuard has the best ratio of life years gained to unnecessary colonoscopies. Colonoscopy has the highest life years gain. Some of that is simply because of the assumptions in the model. It also has the highest number of unnecessary colonoscopy. So colonoscopy that is performed that doesn't find in it, which is the majority of colonoscopies.

所以第一個問題，你是在考驗我對排名的記憶。 Cologuard 具有所有篩選測試中最佳的比率。 Cologuard 獲得的生命年與不必要的大腸鏡檢查的比例最高。大腸鏡檢查具有最高的生命年增益。其中一些僅僅是因為模型中的假設。它的不必要大腸鏡檢查次數也最多。因此，大多數大腸鏡檢查中都沒有發現大腸鏡檢查。

Between the FIT test and Cologuard, the FIT test done every single year, which, by the way, only about 3 people in 1,000 due to FIT test every year for a decade. But if you model it that way, compared to Cologuard every 3 years, the FIT test detects about, just like maybe 7% or 8% more life years it saves 5% to 10% more of life years than Cologuard. CRC blood falls off by like 25% because of the lack of sensitivity of refining precancerous polyps.

在 FIT 測試和 Cologuard 之間，FIT 測試每年都會進行，順便說一下，十年來，每年 1,000 人中只有大約 3 人進行 FIT 測試。但如果按照這種方式建模，與每 3 年進行一次的 Cologuard 相比，FIT 測試會檢測到大約 7% 或 8% 的生命年，它比 Cologuard 多節省 5% 到 10% 的生命年。由於缺乏提煉癌前息肉的敏感性，CRC 血液下降約 25%。

And this is the challenge. So I'd go back and reread this part of the script, and we read it again. This is the challenge. To getting an A or B rated test. They don't hand out As or Bs very easily at the USPSTF. This isn't like great inflation in some U.S. colleges. This is -- if there is a standard and it's driven off of this model. Precancer detection matters.

這就是挑戰。所以我會回去重讀劇本的這一部分，然後我們再讀一次。這就是挑戰。獲得 A 或 B 級測試。 USPSTF 不會輕易給出 A 或 B 的成績。這與美國一些大學的嚴重通貨膨脹不同。這是——如果有一個標準並且它脫離了這個模型。癌前檢測很重要。

So this is Jeff on your EBITDA question. Look, we gave the guidance last summer. We ended last year a lot further along towards our long-term goals. Remember, our long-term goal is for at least a 20% EBITDA margin in 2027. Last year, we're at 9%, we're ways ahead of plan here. This year, we expect another 3 points improvement over time, I expect continued increase every year. That's what we built here. We built a foundation, our customer technology platform, our labs, our sales teams, you name it, to scale, scale very effectively.

這是 Jeff 回答您的 EBITDA 問題。看，我們去年夏天就給了指導。去年，我們在實現長期目標方面取得了巨大進展。請記住，我們的長期目標是在 2027 年實現至少 20% 的 EBITDA 利潤率。去年，我們的目標是 9%，遠遠超出了計劃。今年，我們預計隨著時間的推移，會再提高 3 個百分點，我預計每年都會繼續成長。這就是我們在這裡建造的。我們建立了一個基礎，我們的客戶技術平台，我們的實驗室，我們的銷售團隊，凡是你能想到的，都可以非常有效地擴展。

When you look at the numbers this year, I do expect to see leverage again across all 3 major OpEx lines. Sales and marketing after the last 2 years where that had come down in absolute terms. Everett's done a really nice job of leading this team, but we see such strong return on investment there that we are going to raise some investment there. Just it makes sense to -- it's the right way to grow this business, it's the right way to take care of patients and add value to the system. So we will invest in all 3.

當你查看今年的數字時，我確實預計所有 3 個主要營運支出領域都會再次發揮槓桿作用。過去兩年，銷售和行銷的絕對值有所下降。埃弗里特在領導這個團隊方面做得非常出色，但我們看到那裡的投資回報如此之高，因此我們將在那裡籌集一些投資。這是有意義的——這是發展這項業務的正確方式，這是照顧患者和為系統增加價值的正確方式。所以我們將投資全部 3 個。

We talked about last year, midyear, we accelerated investment in our MRD program given the near-term opportunity there. And as some of the bigger programs get towards market, the investment dollars do increase temporarily. And then G&A. G&A, I think the biggest source of leverage. We've got major initiatives there across our customer care teams, our customer experience teams and IT that over time will not only help accelerate growth further, but also help us run the business more efficiently.

我們去年年中談到，鑑於近期的機會，我們加快了對 MRD 計畫的投資。隨著一些較大的項目進入市場，投資金額確實會暫時增加。然後是一般行政費用。 G&A，我認為最大的槓桿來源。我們在客戶服務團隊、客戶體驗團隊和 IT 方面採取了重大舉措，隨著時間的推移，這些舉措不僅有助於進一步加速成長，還有助於我們更有效地經營業務。

Yes. And let me add on to that what Jeff just emphasized about continued investments. As we've mentioned, we've taken our sales and marketing spend down by over $100 million over the last 2 years. We believe that if we -- we're investing more, we would be growing even faster. This isn't supposition. We have very sophisticated modeling that shows the responsiveness of marketing and sales activity to the output. And during that same period of time, we have grown $870 million from a revenue basis. So it's judicious, it's prudent for us to make additional investments so that we can grow faster and grow profits faster so that we can reinvest and move forward. Ev?

是的。讓我補充一下傑夫剛才強調的關於持續投資的內容。正如我們所提到的，過去 2 年我們的銷售和行銷支出減少了 1 億多美元。我們相信，如果我們加大投資，我們的成長將會更快。這不是假設。我們有非常複雜的模型，可以顯示行銷和銷售活動對產出的反應程度。同一時期，我們的營收成長了 8.7 億美元。因此，我們進行額外投資是明智的，謹慎的，這樣我們就可以更快地成長，更快地增加利潤，這樣我們就可以再投資並繼續前進。伊芙？

No. And I'm glad we're at the point that we are because our data and analytics get better as I speak. And that matches really nicely with our market structure to where the data and analytics just don't sit at my level, but they go all the way down to the local level so we can invest in resources smartly, and that's driven by our local leaders. They make the call in terms of where that opportunity of growth is, where we can grow our business and continue to be a real value to our patients and customers.

不。我很高興我們現在已經做到了這一點，因為在我講話的時候，我們的數據和分析變得更好了。這與我們的市場結構非常匹配，數據和分析不屬於我的水平，但它們一直延伸到地方水平，因此我們可以明智地投資資源，這是由我們當地領導者推動的。他們做出的決定是，成長機會在哪裡，我們可以在哪裡發展我們的業務，並繼續為我們的患者和客戶帶來真正的價值。

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

你的下一個問題來自 Dan Arias 和 Stifel 的線路。

Kevin I, too, wanted to go back to the blood-based assay development topic, which I'm sure you don't love, but hopefully, you can appreciate just how much that's playing into the stock compensation for you guys right now or at least for us anyways. .

凱文，我也想回到基於血液的檢測開發主題，我相信你不喜歡這個主題，但希望你能意識到這對你們現在的股票薪酬有多大影響，或者至少對我們來說是這樣。 。

My question is really, though, on process rather than performance. You mentioned the importance of USPSTF. When we think about that, can you just talk to the confidence that you have when it comes to getting everything squared away in time for consideration there?

不過，我的問題實際上是關於過程而不是性能。您提到了 USPSTF 的重要性。當我們想到這一點時，您能否談談您在及時解決所有問題以供考慮方面所擁有的信心？

In other words, if the data reads out midyear and the guideline folks want everything to them by, say, early 2025, is there any reason why you wouldn't make the cut off there for whatever they need for their evaluation?

換句話說，如果數據在年中讀出，並且指導人員希望在 2025 年初之前向他們提供一切，那麼您是否有任何理由不在那裡截斷他們評估所需的任何內容？

No, we will make that cutoff. We will make that cutoff.

不，我們會做到這一點。我們將做到這一點。

And is that the right time line that you are assuming -- plays out on that by the end of this year, USPSTF is ready to accept data and have what they need in front of them in order to do this thing?

您假設的時間線是否正確——到今年年底，USPSTF 已準備好接受數據並擁有完成這項工作所需的資訊？

So if you look at this historically, the last cycle was, I believe, 5 years in between updates. The cycle before that was 8 years. It's a group of volunteers. They do dozens and dozens and dozens of guideline updates every year. They have limited resources. So they are due to have the final update by '26. Does that get pushed out? We don't know. We would expect in the nearer term to see something from USPSTF where they lay out what's called their study plan.

因此，如果您從歷史角度來看，我相信上一個週期的更新間隔為 5 年。先前的周期為8年。這是一群志工。他們每年都會進行數十次指南更新。他們的資源有限。所以他們預計會在 26 年前完成最終更新。這會被推出去嗎？我們不知道。我們預計在不久的將來會看到 USPSTF 的一些內容，他們會制定所謂的研究計劃。

The topics they review, the essential timing, et cetera. And we haven't seen that yet. But it was 8 years, and then it was 5 years. We'll see if is it 5 years? Is it 6 years? Is it longer? We don't know.

他們複習的主題、基本時間等等。我們還沒有看到這一點。但8年過去了，5年過去了。我們看看是不是5年？是6年嗎？是不是更長了？我們不知道。

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

你的下一個問題來自安德魯·布拉克曼和威廉·布萊爾的對話。

I want to go back to some of the comments on health system efforts. Obviously, it sounds like you guys are providing these systems a lot of value with some of the things that you're doing internally. But can you maybe just sort of talk structurally about those partnerships? Is there anything in those contractually or sort of what you guys are -- have with those partnerships that can potentially ward off competition if that does come in over the next handful of years?

我想回到一些關於衛生系統工作的評論。顯然，聽起來你們正在透過內部所做的一些事情為這些系統提供很多價值。但您能否從結構上談談這些夥伴關係？如果在未來幾年內出現這種情況，這些合約或你們之間的合作關係是否有可能避免競爭？

Yes. It's less about contractually and more about the value that we're bringing into health systems. Health systems, we've seen this over the past couple of years, they're coming to us and they're coming to us to solve health care problems and issues. One is around screening. And so we find that -- and then I also have health systems tell us on a daily basis. We need to go beyond the product. So the one thing -- many things that we bring to health systems are great products, outstanding customer support, of which they're looking for.

是的。這與合約無關，更多的是我們為衛生系統帶來的價值。衛生系統，我們在過去幾年中已經看到了這一點，他們來找我們，來找我們解決衛生保健問題和問題。一是圍繞篩檢。所以我們發現──然後我也有衛生系統每天告訴我們。我們需要超越產品。因此，我們為衛生系統帶來的許多東西都是他們所尋求的優質產品和出色的客戶支援。

We have an outstanding medical organization that partners with them and so they love our surround sound. And it fits Cologuard, Oncotype DX, OncoExTra. And what's also exciting is our portfolio that drops right into our bag, and we can sell a portfolio to them. So it's all about partnership, and it really separates us from the competition in terms of our products. Our portfolio and all the surround sound that we can partner with them and helping them have better health care for their patients.

我們有一個優秀的醫療組織與他們合作，因此他們喜歡我們的環繞聲。它適合 Cologuard、Oncotype DX、OncoExTra。同樣令人興奮的是我們的投資組合可以直接放入我們的包中，我們可以將投資組合出售給他們。因此，這一切都與合作夥伴關係有關，這確實使我們在產品方面從競爭對手中脫穎而出。我們的產品組合和所有環繞音響可以與他們合作，幫助他們為患者提供更好的醫療保健。

Yes. It's incredible. The technology stack that we've developed that creates a competitive uniqueness. And that investment has been well over $1 billion. It's about 100 different applications internally built, externally sourced that lead to this compliance engine that Everett referred to, the ability to automate things like reimbursement, prior authorization campaigns to remind people to get screened population health initiatives.

是的。太不可思議了。我們開發的技術堆疊創造了競爭的獨特性。該投資已遠遠超過 10 億美元。 Everett 提到的合規引擎由大約 100 個內部建置、外部採購的不同應用程式組成，能夠實現報銷、預先授權活動以提醒人們進行人口健康篩檢等活動的自動化。

And so this is a contractual based relationship. It's a relationship based on real value for health systems patients. And it ends up leading to significant growth and profitability.

所以這是一種基於合約的關係。這是一種基於對衛生系統患者的真正價值的關係。它最終會帶來顯著的成長和利潤。

I'll layer in one additional comment. This is Brian, by the way. We are having very meaningful conversations with a number of health systems just to reiterate what Everett was talking about around the portfolio. So while it's not walling off the competition, a lot of these vendors are looking at us as a one-stop shop and thinking about preferred vendor agreements.

我將添加一條附加評論。順便說一句，這是布萊恩。我們正在與許多衛生系統進行非常有意義的對話，只是為了重申埃弗里特圍繞該投資組合所談論的內容。因此，雖然這並沒有阻止競爭，但許多供應商都將我們視為一站式商店，並考慮首選供應商協議。

They're realizing the benefits of transacting with 1 company, talking to 1 customer service rep, calling 1 service number, sending samples to 1 company for testing. So we are having very meaningful and real-time conversations around this preferred vendor agreement type of structure with some of our key customers.

他們正在認識到與 1 家公司進行交易、與 1 名客戶服務代表交談、撥打 1 個服務電話、向 1 家公司發送樣品進行測試的好處。因此，我們正在與一些主要客戶圍繞這種首選供應商協議類型結構進行非常有意義的即時對話。

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

你的下一個問題來自高盛的馬特·賽克斯（Matt Sykes）。

Just two quick ones for me. One, just -- I know you talked about Oncotype DX international growing 48% in the quarter. And I realized that Japan was just launched in October. But could you maybe unpack what Japan represented within that overall international and what type of traction you're seeing there?

對我來說只有兩個快速的。一，我知道您談到 Oncotype DX 國際在本季度增長了 48%。我意識到日本是十月才推出的。但您能否解釋一下日本在整個國際比賽中所代表的內容以及您在那裡看到的吸引力類型？

And then just secondly, Kevin, you talked about -- I think at JPMorgan, you talked about the Oncotype business going from $600 million plus to $1 billion you didn't give a time frame.

其次，Kevin，你談到了——我想在摩根大通，你談到 Oncotype 業務從 6 億美元以上增長到 10 億美元，但你沒有給出時間框架。

But I'm just wondering, could you maybe talk about some of the key drivers to get you there? Just given sort of the low to kind of high single-digit growth we've seen what kind of acceleration that you're expecting to get to that $1 billion? And what are the key drivers for that?

但我只是想知道，您能否談談實現這一目標的一些關鍵驅動因素？考慮到單位數的低成長和高成長，您預計會以什麼樣的速度達到 10 億美元？其關鍵驅動因素為何？

I think Brian can actually take both of these.

我認為布萊恩實際上可以同時接受這兩點。

The first question is related to Japan. Let me put Japan, if I may, in the context of our broader international business. which is approaching about $200 million in annual revenue. I tend to think about our international business in 3 archetypes. We have one group of countries, I think Canada, the U.K., for example, where very established market molecular penetration is standard of care and oncotype brand shares and market share is very, very high.

第一個問題與日本有關。如果可以的話，讓我將日本放在我們更廣泛的國際業務的背景下。年收入接近2億美元。我傾向於用三種原型來思考我們的國際業務。我們有一組國家，例如加拿大、英國，這些國家的市場分子滲透率是護理標準，oncotype 品牌份額和市場份額非常非常高。

The second archetype is where we are driving rapid adoption, both of molecular testing and of Oncotype share. And I'll give you examples like Germany and Italy, as 2 key countries where we're seeing that grow.

第二個原型是我們正在推動分子測試和 Oncotype 共享的快速採用。我將舉德國和義大利這樣的例子，作為我們看到這成長的兩個關鍵國家。

Thirdly, we're launching in new markets. The biggest of which is Japan, which is our largest opportunity. In Japan, there's about 45,000 eligible patients in that important geography. And we expect that, that could contribute about $30 million of growth to 2024 for our international business more broadly.

第三，我們正在開拓新市場。其中最大的是日本，這是我們最大的機會。在日本這個重要的地區大約有 45,000 名符合資格的患者。我們預計，到 2024 年，這將為我們更廣泛的國際業務帶來約 3,000 萬美元的成長。

On the second assumption, again, I think growing to Oncotype to $600 million and the broader PO business to $1 billion. To get to $600 million, we have to do a lot of things. We're continuing to, as I mentioned, penetrate, underpenetrated market. We have an opportunity to launch in new markets. And then we have an opportunity to convert indirect markets to direct markets where we actually have Oncotype sales folk -- teams and resources in country that are under our direct control. So those are some of the key drivers for Oncotype.

同樣，根據第二個假設，我認為 Oncotype 成長至 6 億美元，更廣泛的 PO 業務成長至 10 億美元。為了達到 6 億美元，我們必須做很多事情。正如我所提到的，我們正在繼續滲透、滲透不足的市場。我們有機會開拓新市場。然後我們就有機會將間接市場轉變為直接市場，在直接市場中我們實際上擁有 Oncotype 銷售人員——我們直接控制的國家/地區的團隊和資源。這些是 Oncotype 的一些關鍵驅動因素。

And then outside of Oncotype, the broader business, I would really focus on the expanding pipeline. Within 24 months, we already launched OncoExTra, our tissue therapy selection test. We will launch OncoDetect, which is our MRD platform. We acquired OncoLiquid from the Resolution Bioscience acquisition, which we will introduce in due course. And then we also have Riskguard, our hereditary cancer test. So that growth from $600 million to $1 billion will be driven by that pipeline.

然後，在 Oncotype 這個更廣泛的業務之外，我會真正專注於不斷擴大的產品線。 24 個月內，我們已經推出了 OncoExTra，我們的組織治療選擇測試。我們將推出 OncoDetect，這是我們的 MRD 平台。我們透過收購Resolution Bioscience 收購了OncoLiquid，我們將在適當的時候推出這項舉措。然後我們還有 Riskguard，我們的遺傳性癌症測試。因此，該管道將推動從 6 億美元到 10 億美元的成長。

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

您的下一個問題來自花旗集團的 Patrick Donnelly。

Kevin, maybe just on MRD. Can you talk a little bit about expectations for this year? What we should be looking for, both on the data side and then just the ramp? And also, how do you think about the incremental dollars invested? I know previously, MRD was above blood on the early detection side. Maybe just talk a little bit about the priorities there would be helpful.

凱文，也許只是在 MRD 上。能談談對今年的期望嗎？我們應該在數據方面尋找什麼，然後只是在斜坡方面？另外，您如何看待增量投資？我以前知道，在早期檢測方面，MRD 高於血液。也許只討論一下那裡的優先事項會有幫助。

I'm going to hand this one over to Brian as well.

我也要把這個交給布萊恩。

Thanks, Kevin, and thank you for all the questions about Precision Oncology. Welcome them. Let me just say that I'll reiterate, Kevin mentioned at the top of the call that we're here in San Diego. And I'm so proud of the team that worked so hard over the last months and years to develop an organic MRD product, which we're now calling OncoDetect.

謝謝凱文，也謝謝您提出所有關於精準腫瘤學的問題。歡迎他們。讓我重申一下，凱文在電話頂部提到我們在聖地牙哥。我為這個團隊感到非常自豪，他們在過去的幾個月和幾年裡努力開發有機 MRD 產品，我們現在稱之為 OncoDetect。

So hugely proud of the team here in San Diego and also equally proud of the team in our Phoenix lab, who is working through the validation of that test at breakneck speed. So in terms of what you can expect from MRD, apologies, there's -- the sound of freedom behind us here in San Diego, if there's noise in the background.

我們為聖地牙哥的團隊感到非常自豪，也同樣為我們鳳凰城實驗室的團隊感到自豪，他們正在以極快的速度驗證該測試。因此，就您對 MRD 的期望而言，抱歉，如果背景中有噪音，我們在聖地亞哥的背後就是自由的聲音。

What you can expect in terms of MRD? We are already having a very meaningful and material discussion with customers as well as Medicare on the payer side of the equation. We're excited to share the powerful data that we believe will help us secure Medicare reimbursement later this year.

您對 MRD 有何期望？我們已經與客戶以及支付方的醫療保險進行了非常有意義和實質的討論。我們很高興分享強大的數據，我們相信這些數據將幫助我們在今年稍後獲得醫療保險報銷。

And then we're working very closely in the business unit with Everett and the commercial team to work through the commercial planning activities and very much look forward to introducing that test into the commercial team later this year or very early next year. And that time line is very dependent on how quickly Medicare gets back to us on the reimbursement side of the equation, which can vary by a few months. But ultimately, that will determine when we really step on the accelerator from a commercialization perspective.

然後，我們在業務部門與 Everett 和商業團隊密切合作，完成商業規劃活動，並非常期待在今年稍後或明年初將該測試引入商業團隊。該時間線很大程度上取決於醫療保險在報銷方面向我們反饋的速度，這可能會相差幾個月。但最終，這將決定我們何時真正從商業化的角度加速。

One of the things that I'll add before Jeff, you can comment on some of the contributions financially, I believe we are really competitively unique in the MRD space. We are thinking very creatively about how to integrate the portfolio, particularly the Oncotype portfolio into our evidence development plans around OncoDetect and then I'll take you back to the IT platform that Kevin mentioned earlier on the call. It will allow us to do prior authorizations, billing and reimbursement but it will also allow us to bring forward a lot of the great tools that we're developing for Cologuard around adherence, compliance.

我要在 Jeff 之前補充的一件事是，您可以對一些財務貢獻發表評論，我相信我們在 MRD 領域確實具有獨特的競爭優勢。我們正在非常有創意地思考如何將產品組合，特別是 Oncotype 產品組合整合到我們圍繞 OncoDetect 的證據開發計劃中，然後我將帶您回到 Kevin 之前在電話會議中提到的 IT 平台。它將使我們能夠進行事先授權、計費和報銷，但它也將使我們能夠圍繞遵守和合規性為 Cologuard 開發許多出色的工具。

If you think about the work that they're doing, we're asking patients to do a test every 3 years. With respect to OncoDetect, we'll be asking a patient to do a test every 3 months, which is very difficult and challenging, particularly in the out years, when a patient is tested negative for 3, 4 years consecutively. We need to get that patient tested in year 4 and 5. And I believe strong that, that adherence and compliance engine can be ported over to support the patients around MRD and OncoDetect.

如果您考慮他們正在做的工作，我們會要求患者每 3 年進行一次測試。對於OncoDetect，我們會要求患者每3個月進行一次檢測，這是非常困難且具有挑戰性的，特別是在過去的幾年中，當患者連續3、4年檢測呈陰性時。我們需要在第 4 年和第 5 年對患者進行測試。我堅信，可以移植依從性和合規性引擎來支援 MRD 和 OncoDetect 的患者。

Over to you, Jeff .

交給你了，傑夫。

Patrick, this is Jeff. From a modeling standpoint, we've been -- as usual, have been sober about the revenue contribution we're assuming this year. It's really more of a 2025 effect, given the base of this business, $2.8 billion MRD, while this is one of our biggest pipeline opportunities, I don't expect a material contribution from a revenue standpoint until next year. From an R&D investment standpoint, this has been and continues to be one of our top 3 investment areas.

派崔克，這是傑夫。從建模的角度來看，像往常一樣，我們對今年的收入貢獻保持著清醒的態度。考慮到該業務的基礎為28 億美元的MRD，這實際上更像是2025 年的影響，雖然這是我們最大的管道機會之一，但從收入的角度來看，我預計直到明年才會產生實質貢獻。從研發投資的角度來看，這一直是並將繼續成為我們的三大投資領域之一。

Colon cancer screening. Broadly, MRD and multi-cancer are the big 3. In MRD last year, we did step up the investment given that the near term opportunity we see.

大腸癌篩檢。總的來說，MRD 和多種癌症是三大癌症。在去年的 MRD 中，鑑於我們看到的近期機會，我們確實增加了投資。

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

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

Thank you. Good afternoon. for Kevin or Jeff, I was hoping for an update on multi-cancer. We're still waiting on progress in B.C. around the Medicare benefit. Is there any context you can share around what's in the earnings forecast around R&D investment for MCED? And are you still planning to move forward with [Sword] at this point?

謝謝。午安.對於凱文或傑夫，我希望了解多種癌症的最新情況。我們仍在等待 BC 省的進展。圍繞醫療保險福利。您是否可以分享有關 MCED 研發投資的獲利預測的背景資訊？那現在你還打算繼續《劍》嗎？

Well, it's -- we have been saying for probably the prior 18 months if Congress did not moved to pass legislation to explicitly give Medicare the authority to pay for a multi-cancer early detection test, we would likely scale back our investment. We have scaled back our investment in MCED. In the long term, we still believe that multi-cancer early detection is going to be much more impactful even than Cologuard in terms of creating real value for patients. In terms of this year's impact, Jeff, you can give color or not?

嗯，我們可能在過去 18 個月裡一直在說，如果國會不採取行動通過立法，明確賦予 Medicare 支付多種癌症早期檢測測試費用的權力，我們可能會縮減投資。我們縮減了對 MCED 的投資。從長遠來看，我們仍然相信，在為患者創造真正價值方面，多癌症早期檢測的影響力甚至比 Cologuard 還要大得多。就今年的影響而言，傑夫，你能不能給點顏色？

We did moderate the level of investment in multi-cancer temporarily. As Kevin said, until we see a more clear pathway to reimbursement. From an R&D standpoint, though, it is still 1 of our big 3 investment areas. Those 3 areas to add more color to it.

我們確實暫時降低了對多種癌症的投資水準。正如凱文所說，直到我們看到更明確的報銷途徑。但從研發的角度來看，它仍然是我們三大投資領域之一。這三個區域可以為其添加更多色彩。

Again, colon cancer broadly. Multi-cancer and MRD are over 2/3 of our R&D investment probably closer to 3 quarters. So they are investments that represent the opportunity that we see and the value we can provide for both shareholders and patients.

再說一次，廣義的結腸癌。多種癌症和 MRD 占我們研發投資的 2/3 以上，可能接近 3 個季度。因此，這些投資代表了我們看到的機會以及我們可以為股東和患者提供的價值。

Your next question comes from the line of Puneet Souda with Leerink Partners.

您的下一個問題來自 Puneet Souda 和 Leerink Partners 的電話。

Kevin, if you could -- you covered the blood competition questions very well. But I was just wondering, can you elaborate a bit on the expectations for the BLUE-C blood readout mean should we expect that to be in line with the comments you made on blood broadly? And maybe just around advanced adenoma performance there. How important is that in the BLUE-C blood readout? And just remind us how this assay is positioned in your portfolio?

凱文，如果可以的話——你很好地回答了血液競賽問題。但我只是想知道，您能否詳細說明一下對 BLUE-C 血液讀數的期望，這意味著我們是否應該期望它與您對血液的廣泛評論一致？也許就在高級腺瘤的表現附近。這對於 BLUE-C 血液讀數有多重要？請提醒我們該檢測在您的產品組合中如何定位？

Sure. Let me start with the last question first, Puneet. The -- our blood test, and we think as a class most likely blood test will be -- will receive a best second-line screening claim by the FDA. That means, and you've seen this before with the SEPT9 test, a test to be used when a patient refuses frontline tests that are in the USPSTF guidelines.

當然。讓我先從最後一個問題開始，Puneet。我們的血液測試，我們認為最有可能的血液測試類別，將獲得 FDA 的最佳二線篩檢聲明。這意味著，您之前已經在 SEPT9 測試中看到過這一點，這是當患者拒絕 USPSTF 指南中的前線測試時使用的測試。

So we know who the patients are that refuse high-quality tests like Cologuard and colonoscopy and when they refuse those test there's an opportunity for us to help those patients at least get screened even if the doc isn't going to get a quality credit or the Medicare Advantage plan, et cetera, still an uphill battle, no doubt.

因此，我們知道哪些患者拒絕 Cologuard 和大腸鏡檢查等高品質測試，當他們拒絕這些測試時，我們有機會幫助這些患者至少接受篩檢，即使醫生不會獲得品質信用或毫無疑問，醫療保險優勢計劃等仍然是一場艱苦的戰鬥。

One of the things that's competitively unique about our approach is just the cost structure. It's a test that's built on a supercharged PCR platform. And that provides a cost structure that we believe will be best-in-class and provide real value to the health system and to those patients that get tested. So that will allow us, we think, to be -- that coupled with our commercial organization, our IT infrastructure to lead in this field.

我們的方法在競爭中的獨特之處之一就是成本結構。這是建立在強大的 PCR 平台上的測試。這提供了一個我們相信是同類最佳的成本結構，並為衛生系統和接受檢測的患者提供真正的價值。我們認為，這將使我們能夠與我們的商業組織和 IT 基礎設施相結合，在這一領域處於領先地位。

It's just -- I'll take you back to 2014, '15, '16 when we first launched Cologuard without being included in the quality measures until I believe 2017, we were really limited in terms of the patients that we could address and we believe that's going to be the case with any test that isn't in the guidelines or quality measures. So that's how we're looking at things. In terms of what our expectations are for data. We're getting pretty close to that date. So we'll let the data speak for themselves.

只是 - 我將帶您回到 2014 年 15 年、16 年，當時我們首次推出 Cologuard，但沒有納入質量衡量標準，直到我相信 2017 年，我們可以解決的患者數量確實有限，而且我們相信指南或質量措施中未包含的任何測試都會出現這種情況。這就是我們看待事物的方式。就我們對數據的期望而言。我們已經非常接近那個日期了。所以我們會讓數據來說話。

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

你的下一個問題來自安德魯庫柏和雷蒙詹姆斯的對話。

Maybe just sticking with MRD since we've talked a lot about Cologuard. You called out -- submitted for reimbursement or expecting reimbursement this year, I think for colon I think the slide also said validation data for breast as well. I just want to get a little bit better understanding of -- should we expect that, that's the sort of data to support reimbursement? Is it broadly? Is it more narrow for a portion of breast patients? Just a little bit of help there. And then as we think about these launches, I know, Jeff, you called out a little bit of kind of increased R&D or increased OpEx in the prep for the launch.

也許只是堅持使用 MRD，因為我們已經談論了很多 Cologuard。您喊出了 - 已提交報銷或預計今年報銷，我認為對於結腸，我認為幻燈片也提到了乳房的驗證數據。我只是想更好地理解——我們是否應該期待這樣的數據來支持報銷？是廣義的嗎？是否有部分乳房患者的範圍較窄？只是有一點幫助。然後，當我們考慮這些發佈時，我知道，傑夫，您在發布準備過程中呼籲增加研發或增加營運支出。

But anything we should think about in terms of gross margin impact versus sort of the tailwinds you'll have with next-generation Cologuard and things like that as we think longer term, especially if some of these are not widely reimbursed at least by commercial upfront.

但從長遠來看，我們應該考慮毛利率影響與下一代 Cologuard 等方面的順風，尤其是如果其中一些至少沒有透過商業預付款得到廣泛補償的話。

Thanks for the question. In terms of the breast data, most of the data that we're generating right now is really validating the platform. And the plan would be to look towards Medicare more in the 2025 horizon on the breast side.

謝謝你的提問。就乳房數據而言，我們現在產生的大部分數據確實在驗證該平台。該計劃將在 2025 年更多地關注乳房方面的醫療保險。

As you may or may not know, some of these subtypes of breast cancer can be somewhat challenging. They tend to be sort of what are known as low shedding tumors, meaning there's not a lot of ctDNA in the blood and so one of the things that we're doing is setting up study such that we can look at our current version of OncoDetect, but also look at what the technology that we license from the Broad Institute known as MAESTRO might allow us to do. And what that technology allows us to do is really twofold. One, it allows us to shift from whole exome to whole genome to design the assay.

您可能知道也可能不知道，其中一些乳癌亞型可能具有一定的挑戰性。它們往往是所謂的低脫落腫瘤，這意味著血液中沒有大量 ctDNA，因此我們正在做的事情之一就是開展研究，以便我們可以了解當前版本的 OncoDetect ，同時也看看我們從Broad Institute 獲得許可的名為MAESTRO 的技術可以讓我們做些什麼。這項技術讓我們能夠做的事情實際上是雙重的。第一，它使我們能夠從全外顯子組轉向全基因組來設計檢測方法。

And thereby, we can find more mutations that we then want to track in the patient's blood and two, it allows us to track more mutations in a patient's blood at a very, very attractive cost point. So we maintain very high gross margin on that particular product.

因此，我們可以找到更多我們想要在患者血液中追蹤的突變，第二，它使我們能夠以非常非常有吸引力的成本點追蹤患者血液中的更多突變。因此，我們在該特定產品上保持非常高的毛利率。

So it's a little bit too early to say about when we go full force in blood because we do want to deliver a technology that is competitively unique and differentiated. And we are not sure based on the data that we've seen to date from some of the players in the field, whether in certain subtypes the performance is really there. And so we're being very careful about how we think about evidence building and investment in breast based on the different technology stacks that we have.

因此，現在談論我們何時全力以赴還為時過早，因為我們確實希望提供一種具有競爭優勢的獨特且差異化的技術。根據我們迄今為止從該領域的一些參與者看到的數據，我們不確定在某些子類型中是否真的存在這種表現。因此，我們非常謹慎地考慮如何根據我們擁有的不同技術堆疊來建立證據和投資乳房。

On gross margins, more broadly, I expect steady improvement for years to come. When you look at our pipeline, Cologuard 2 should carry even better gross margins than Cologuard 1, given that the team did a fabulous job of finding efficiencies to build into the cost of goods. So and we've talked before about having at least a 5% reduction in cost per test for Cologuard 2 based on the investment and the efficiencies we gain.

更廣泛地說，我預計未來幾年毛利率將穩定改善。當您查看我們的產品線時，您會發現 Cologuard 2 的毛利率應該比 Cologuard 1 更高，因為團隊在尋找提高商品成本的效率方面做得非常出色。因此，我們之前已經討論過，根據投資和我們獲得的效率，Cologuard 2 的每次測試成本至少降低 5%。

So new products overall should help drive better gross margins temporarily some, as you highlighted that don't carry full reimbursement in the beginning. Could put a little network pressure, but I think the overall gross margin still continues to walk higher.

因此，總體而言，新產品應該有助於暫時提高毛利率，正如您所強調的那樣，新產品一開始並不提供全額報銷。可能會帶來一點網路壓力，但我認為整體毛利率仍然繼續走高。

From an OpEx standpoint, though, given the investment in this broader foundation, again, the teams that are in the field, Brian could talk all day long about the fabulous team we've got out in the field with Precision Oncology, the deep relationships they have.

不過，從營運支出的角度來看，考慮到對這個更廣泛基礎的投資，以及該領域的團隊，布萊恩可以整天談論我們在精準腫瘤學領域擁有的出色團隊，以及深厚的關係他們有。

That foundation provides a very attractive incremental leverage opportunity as you introduce new products, it's a lot of the same physicians you're calling on. In many cases, it's the same patient in the same block of tissue that you're using for both Oncotype DX today and then MRD and therapy selection down the road. So from a margin standpoint, these are really good investments for us to make now and for years to come.

當您推出新產品時，該基礎提供了非常有吸引力的增量槓桿機會，而您所拜訪的醫生是許多相同的醫生。在許多情況下，您今天使用的 Oncotype DX 以及未來的 MRD 和治療選擇都是同一位患者的同一塊組織。因此，從利潤的角度來看，這些對我們現在和未來幾年來說確實是很好的投資。

Your next question comes from the line of Dan Leonard with UBS.

你的下一個問題來自瑞銀集團的 Dan Leonard。

So I have a couple of questions on Cologuard 2.0. First, could I get your latest thinking on what pricing could look like for that product? And then secondly, when would you expect the BLUE-C study could get published?

我有幾個關於 Cologuard 2.0 的問題。首先，我能否了解您對該產品定價的最新想法？其次，您預期 BLUE-C 研究什麼時候可以發表？

In terms of publication of the BLUE-C study, we would hope that would be in the nearer term, if you never can tell, but in the nearer term. In terms of pricing, all we will say here is we are creating value. In particular, we've developed a test that detects 30% fewer false positives that directly saves the health care system significant money.

就 BLUE-C 研究的發表而言，我們希望能在近期發表，如果你永遠無法確定的話，但在近期。在定價方面，我們在這裡要說的是我們正在創造價值。特別是，我們開發了一種測試，可以將誤報率減少 30%，從而直接為醫療保健系統節省大量資金。

It saves patients from having to unnecessarily undergo an invasive procedure. And so that's a tangible value. And because of the huge investment we've made and resetting a much higher bar we expect to get value from that. But in terms of providing any specific pricing guidance, that is not going to happen until you see the day that it is priced by Medicare and commercial payers. So that's all we can offer.

它使患者不必接受不必要的侵入性手術。所以這是一個有形的價值。由於我們進行了巨額投資並設定了更高的標準，我們希望從中獲得價值。但就提供任何具體的定價指引而言，直到你看到醫療保險和商業付款人定價的那一天，這種情況才會發生。這就是我們所能提供的。

Your next question comes from the line of Subbu Nambi with Guggenheim.

你的下一個問題來自 Subbu Nambi 與古根漢的合作。

An extension to Doug's question actually, what's the rescreen hit rate? In the past, you said it was 55%. Do you expect it to increase in 2024 and just from an observation perspective, do you see individuals who are eligible for rescreen stick to the 3-year mark? Or do you see a lag of a few quarters? Basically, what percent of 2024 rescreen eligible patients actually spill over to 2025?

實際上是道格問題的延伸，重螢幕命中率是多少？過去你說是55%。您預計 2024 年這個數字會增加嗎？僅從觀察的角度來看，您認為有資格重新篩選的人會堅持 3 年嗎？或者您看到了幾個季度的滯後？基本上，2024 年重新篩檢符合條件的患者中有多少百分比實際上會延續到 2025 年？

Sure. Subbu, this is Jeff. Thanks for the question. The success rate is a bit below what you said today. However, it is moving higher quickly. We see consistent progress every quarter. And the longer-term goal is to get to a 70%. That's very good. When you put it in perspective for FIT testing, for example, on the first go round, the first test is often at, say, 20% over time that, as Kevin talked earlier, only about 3 out of 1,000 people complete the test every year for 10 years.

當然。蘇布，這是傑夫。謝謝你的提問。成功率比你今天說的低。然而，它正在迅速走高。我們每季都看到持續的進步。長期目標是達到70%。這是非常好的。當你從FIT 測試的角度來看時，例如，在第一輪測試中，隨著時間的推移，第一次測試通常會達到20%，正如Kevin 之前所說，每次測試只有千分之三的人完成測試。年 10 年。

So even where we're at today is a good outcome, we think we can do even better though. Of the people who become eligible in a given year, it takes about 3 years, call it, 3.5 years for them to come back. So if 1.6 million people become eligible this year, some of those people would become eligible I'd say, December. Well, they're not going to probably get retested until next year. So if you look at the median time to rescreen, it's closer to 3.5 years.

因此，即使我們今天的成績是好的，但我們認為我們可以做得更好。在某一年符合資格的人中，大約需要 3 年，即 3.5 年才能回來。因此，如果今年有 160 萬人符合資格，我想說，其中一些將在 12 月符合資格。好吧，他們可能要到明年才會重新測試。因此，如果您查看重新篩選的中位數時間，您會發現它接近 3.5 年。

Again, that time frame is coming in, but it doesn't happen immediately. It takes a little bit of time to go out and get that person back to the doctor and get them rescreened.

同樣，這個時間框架即將到來，但它不會立即發生。出去讓那個人去看醫生並重新進行篩檢需要一點時間。

And if I could just add something from a customer standpoint, from a rescreen. When we look at our rescreen population, we give them that customer experience our customers, our doctors, health care providers, they build confidence in the brand and ordering Cologuard.

如果我可以從客戶的角度添加一些東西，從重新篩選。當我們審視重新篩選的人群時，我們為他們提供客戶體驗，我們的客戶、我們的醫生、醫療保健提供者，他們對品牌和訂購 Cologuard 建立了信心。

And I see that as the rescreen population gets bigger, as we get more ordering prescribers, the rescreen population helps all around in terms of confidence, compliance, customer experience, and we're seeing that across the country.

我發現，隨著重新篩選人群的增加，隨著我們擁有更多的處方處方者，重新篩選人群在信心、合規性、客戶體驗方面都有所幫助，我們在全國範圍內都看到了這一點。

And your last question comes from the line of Mark Massaro with BTIG.

你的最後一個問題來自 BTIG 的 Mark Massaro。

So my first question is OncoLiquid. When can we see data? When do you think we can see this commercially launched? And can you discuss timing around Medicare reimbursement? And then my second question is, obviously, we've been getting a lot of questions on what the minimum bar might be for advanced adenomas to be considered a first-line test.

我的第一個問題是 OncoLiquid。什麼時候可以看到數據？您認為我們什麼時候可以看到該產品投入商業化？能否討論一下醫療保險報銷的時間安排？然後我的第二個問題是，顯然，我們收到了很多關於晚期腺瘤被視為一線測試的最低標準的問題。

Kevin, you talked about 24% for FIT. Is it reasonable to think that perhaps folks might anchor the 24% number? Or how are you thinking about that minimum level?

Kevin，你談到了 FIT 的 24%。認為人們可能會固定 24% 的數字是否合理？或者你如何看待這個最低水準？

Well, other -- thanks, Mark. Others have gone at this. Ultimately, this is an FDA decision, and I believe they're getting input on this decision in a public form in March. And I'm sure they're thinking hard about this. But I -- what's the general sense? It's probably going to be in the 20-plus range. Hard to tell. So that is not -- that is supposition at its best.

好吧，其他的——謝謝，馬克。其他人已經這樣做了。最終，這是 FDA 的決定，我相信他們會在三月以公開形式獲得對此決定的意見。我確信他們正在認真思考這個問題。但我──一般意義是什麼？大概會在20以上的範圍內。很難說。所以這不是——這只是最好的假設。

But again, it goes back to the performance in the modeling and the modeling bar that Efficient Frontier is the FIT test defines that in part with 24% detection. So you can't be too far away from that.

但同樣，這又回到了建模和建模欄的效能，Efficient Frontier 是 FIT 測試部分定義的 24% 偵測率。所以你不能離那太遠。

OncoLiquid. I can -- this is Brian again. I can take that one. So we're really excited about the technology that we inherited as part of the Res Bio team as well as the team that we inherited up in up in Kirkland, Washington, just outside of Seattle. So a very robust chemistry platform that has been developed over many years by that team. I'm really excited to get that in the hands of our commercial team. The team right now is working on validating that test and backbone so that we can get Medicare reimbursement as well as New York State approval. And we have a goal to submit to Medicare. This calendar year for reimbursement on the OncoLiquid side of the equation.

Onco液體。我可以——這又是布萊恩。我可以接受那個。因此，我們對作為 Res Bio 團隊的一部分繼承的技術以及我們在西雅圖郊外的華盛頓州柯克蘭繼承的團隊感到非常興奮。因此，該團隊多年來開發了一個非常強大的化學平台。我真的很高興能把它交給我們的商業團隊。該團隊目前正在努力驗證該測試和骨幹，以便我們可以獲得醫療保險報銷以及紐約州的批准。我們的目標是加入醫療保險。本日曆年 OncoLiquid 的報銷。

Let me come back one more time to a topic that people have a lot of interest in. Remember with USPSTF, when they analyze a new screening test, they look at 2 factors, not just life years gain but they also look at the false positive rate of the test leading to unnecessary colonoscopies and the challenge with any of this whole category of blood test is that with plus a 10-ish percent false positive rate, you're generating twice as many unnecessary colonoscopies as the FIT test. That you can't get away from that fact as you look at the model and whether you get to the Efficient Frontier.

讓我再次回到人們非常感興趣的話題。還記得 USPSTF，當他們分析新的篩檢測試時，他們會考慮兩個因素，不僅是壽命年數增長，而且還會考慮假陽性該測試導致不必要的大腸鏡檢查的比率，而整個血液測試類別中的任何一個都面臨的挑戰是，加上百分之十左右的假陽性率，您產生的不必要的大腸鏡檢查數量是FIT 測試的兩倍。當你查看模型以及是否到達有效前沿時，你無法迴避這個事實。

So it's really a combination of adenoma detection in large part cancer detection and minor ironically, and then what is the false positive, right? So the FDA looks at this one way CMS looks at it probably in a similar way as FDA. USPSTF looks at it in totally different way.

所以諷刺的是，這實際上是腺瘤檢測在很大程度上癌症檢測和次要癌症檢測的結合，那麼假陽性是什麼，對嗎？因此，FDA 看待這個問題的方式 CMS 看待它的方式可能與 FDA 類似。 USPSTF 以完全不同的方式看待它。

Thank you, everyone, for your participation. This concludes today's call. You may now disconnect.

謝謝大家的參與。今天的電話會議到此結束。您現在可以斷開連線。