Exact Sciences Corp (EXAS) 2024 Q1 法說會逐字稿

Thank you for standing by. My name is Danica, and I will be your conference operator today. At this time, I would like to welcome everyone to the Exact Sciences First Quarter 2024 Earnings Call. (Operator Instructions). Thank you. I would now like to turn the call over to Erik Holznecht, Manager, Investor Relations. Please go ahead.

謝謝你的支持。我叫丹妮卡，今天我將擔任你們的會議操作員。此時，我謹歡迎大家參加 Exact Sciences 2024 年第一季財報電話會議。 （操作員說明）。謝謝。我現在想將電話轉給投資者關係經理 Erik Holznecht。請繼續。

Thanks Danica. Thank you for joining us for Exact Sciences' First Quarter 2024 Conference Call. On the call today are Kevin Conroy, the company's Chairman and CEO; Jeff Elliott, our Chief Financial Officer; and Aaron Bloomer, Executive Vice President of Finance, who we recently announced as our next Chief Financial Officer. Everett Cunningham, our Chief Commercial Officer, will also be available for questions.

謝謝丹妮卡。感謝您參加 Exact Sciences 2024 年第一季電話會議。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)； Jeff Elliott，我們的財務長；財務執行副總裁亞倫布魯默 (Aaron Bloomer)，我們最近宣布他為下一任財務長。我們的首席商務長 Everett Cunningham 也將回答問題。

Exact Sciences issued a news release earlier this afternoon detailing our first 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 our -- of the risks and uncertainties associated with Exact Sciences are included in our SEC filings. Both can be accessed through our website. I'll now turn the call over to Kevin.

Exact Sciences 今天下午早些時候發布了一份新聞稿，詳細介紹了我們第一季的財務表現。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，並且我們向 SEC 提交的文件中包含了與 Exact Sciences 相關的風險和不確定性的描述。兩者都可以透過我們的網站存取。我現在將電話轉給凱文。

Thanks, Erik. The Exact Sciences team is off to a strong start to the year. During the first quarter, we advanced our [project] of helping to eradicate cancer by further embedding Cologuard as standard of care, increasing adoption of Oncotype DX internationally and deepening our relationships with health systems, payers and patients. Highlights from the first quarter include testing more than 1 million people globally for cancer and rare diseases. Being recognized as a Gallup Exceptional Workplace, a prestigious award given to only 60 companies worldwide. Increasing Cologuard adoption in large health systems, organized screening programs among payers and in federally qualified health clinics. Expanding the number of Oncotype DX international ordering providers by more than 20% year-over-year, making progress towards moving our precision on -- our Precision Oncology portfolio onto [Exact Nexus,] our proprietary IT platform. Launching our hereditary cancer test risk guard through our oncology channel.

謝謝，埃里克。 Exact Sciences 團隊今年開局良好。第一季度，我們透過進一步將 Cologuard 作為護理標準、在國際上增加 Oncotype DX 的採用以及加深我們與衛生系統、付款人和患者的關係，推進了幫助根除癌症的[計畫]。第一季的亮點包括對全球超過 100 萬人進行了癌症和罕見疾病檢測。被評為“蓋洛普卓越工作場所”，這項享有盛譽的獎項僅授予全球 60 家公司。越來越多的大型衛生系統採用 Cologuard，在付款人和聯邦合格的衛生診所中組織篩檢計畫。 Oncotype DX 國際訂購供應商的數量比去年同期增加了 20% 以上，在將我們的精準腫瘤學產品組合轉移到我們專有的 IT 平台 [Exact Nexus] 方面取得了進展。透過我們的腫瘤學管道推出我們的遺傳性癌症測試風險防護。

Announcing the New England Journal of Medicine published results of our pivotal BLUE-C study, which will support FDA approval of Cologuard Plus and generating evidence to support future [steps] including Oncodetect, our molecular residual disease test. These achievements reflect our commitment to solving the needs of patients and health care providers, and we're well positioned to achieve our goals for the year. Jeff will now review our financial results for the quarter.

宣布《新英格蘭醫學雜誌》發表了我們關鍵 BLUE-C 研究的結果，這將支持 FDA 批准 Cologuard Plus 並產生證據來支持未來的[步驟]，包括我們的分子殘留疾病測試 Oncodetect。這些成就反映了我們致力於解決患者和醫療保健提供者需求的承諾，並且我們有能力實現今年的目標。傑夫現在將回顧我們本季的財務表現。

Thanks, Kevin. First quarter revenue of $638 million grew 6% on a reported and core revenue basis. Screening revenue of $475 million increased 7%. Recall Screening revenue in the first quarter of last year was very strong and benefited from enhancements to our billing and patient compliance systems and a weak flu season. Growth was 24% on a 2-year compounded basis. We expect year-over-year growth to be faster than Q1 for the rest of the year. Precision Oncology revenue grew 5% to $163 million, or 4% on a core basis, excluding FX and M&A. [Group] was led by Oncotype DX, which expanded 7% globally. Reference Lab agreements were a headwind of $3 million or 2 points of Precision Oncology growth, as we discussed on our last call. First quarter GAAP gross margin was 70%. Non-GAAP gross margin, excluding amortization of acquired intangibles, was 73%. Margins were slightly lower year-over-year.

謝謝，凱文。第一季營收為 6.38 億美元，按報告和核心收入計算成長 6%。放映收入達 4.75 億美元，成長 7%。去年第一季的回憶篩檢收入非常強勁，這得益於我們的計費和患者合規系統的增強以及流感季節的疲軟。兩年複合成長率為 24%。我們預計今年剩餘時間的年增率將快於第一季。精準腫瘤學收入成長 5%，達到 1.63 億美元，即核心收入成長 4%（不包括外匯和併購）。 [集團] 以 Oncotype DX 為首，全球擴張 7%。正如我們在上次電話會議中討論的那樣，參考實驗室協議是 300 萬美元的阻力，即精準腫瘤學增長的 2 個百分點。第一季 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%。利潤率較去年同期略有下降。

The added fixed cost of automation brought online temporarily weight in Q1.

自動化增加的固定成本在第一季暫時帶來了線上壓力。

We expect gross margins will improve over time as we realize the benefits from lab automation, leverage investments in a lab infrastructure and see an increased mix of rescreened patients. Net loss was $110 million. Adjusted EBITDA was $39 million.

我們預計，隨著時間的推移，毛利率將會提高，因為我們意識到實驗室自動化的好處，利用對實驗室基礎設施的投資，並看到重新篩檢的患者數量不斷增加。淨虧損為 1.1 億美元。調整後 EBITDA 為 3900 萬美元。

Of note, G&A included $4 million of unique onetime items related to facilities consolidation and a $6 million of noncash expense related to acquisition earnouts. In the first quarter last year, G&A was reduced by $9 million from a noncash gain related to earn-outs -- we continue to expect leverage across the P&L this year, especially within G&A. We are taking further steps to optimize costs and increase operational efficiency, enabling us to reinvest in our core business and prepare for new product launches. Free cash flow was negative $120 million during the first quarter, consistent with our expectations and typical seasonal trends. We expect robust cash flow generation for the rest of the year. We ended the quarter with cash and securities of $652 million. In April, we announced our primarily negotiated refinancing. Our primary goal was to smooth and extend existing debt maturities. We accomplished this by issuing $621 million in 2031 notes at attractive financing rates. In return, we have reduced our 2028 notes by $360 million and received $260 million in cash net of fees, bringing first quarter pro forma cash to $912 million. Our capital allocation priorities remain unchanged. Our #1 priority continues to be growing Cologuard and AcatepDx. Second, we're focused on high-return pipeline opportunities with large patient impacts. Turning to guidance. After a good start to the year, we're well positioned to achieve our annual revenue guidance of between $2.81 billion and $2.85 billion and adjusted EBITDA guidance of between $325 million and $350 million. Our recent investments in sales and marketing have already started to pay off in the second quarter. We expect to see a bigger impact in the second half of the year, but we also faced easier comparisons in the second half.

值得注意的是，G&A 包括與設施整合相關的 400 萬美元的獨特一次性項目以及與收購收益相關的 600 萬美元的非現金費用。去年第一季度，由於與利潤相關的非現金收益，G&A 減少了 900 萬美元——我們仍然預計今年損益表中的槓桿率會很高，尤其是在 G&A 中。我們正在採取進一步措施來優化成本並提高營運效率，使我們能夠對核心業務進行再投資並為新產品的推出做好準備。第一季自由現金流為負 1.2 億美元，與我們的預期和典型的季節性趨勢一致。我們預計今年剩餘時間將產生強勁的現金流。本季結束時，我們擁有 6.52 億美元的現金和證券。四月份，我們宣布了初步協商的再融資。我們的主要目標是平滑並延長現有債務期限。我們透過以有吸引力的融資利率發行 6.21 億美元的 2031 年票據來實現這一目標。作為回報，我們將 2028 年票據減少了 3.6 億美元，並收到扣除費用後的 2.6 億美元現金，使第一季預計現金達到 9.12 億美元。我們的資本配置重點維持不變。我們的第一要務仍然是發展 Cologuard 和 AcatepDx。其次，我們專注於對患者產生巨大影響的高回報管道機會。轉向指導。經過今年的良好開局，我們有能力實現 28.1 億至 28.5 億美元的年度收入指引和 3.25 億至 3.5 億美元的調整後 EBITDA 指引。我們最近在銷售和行銷方面的投資已在第二季開始獲得回報。我們預計下半年會產生更大的影響，但下半年我們也面臨更容易的比較。

In addition, we're seeing greater demand for Cologuard and care gap programs run by payers and health systems, which typically accelerate during Q3 and Q4. During the second quarter, we expect total revenue of between $677 million and $697 million. This assumes screening revenue between $522 million and $532 million and Precision oncology revenue between $155 million and $165 million. This is my last exact sciences earnings call. It's been an honor to be part of the team over the past 8 years. I'm extremely proud of what we have accomplished. Together, we've helped build Exact Sciences into a differentiated growth story with strong recurring revenue, healthy margins and a robust balance sheet. Most importantly, we've delivered over 17 million cancer tests. I also want to thank the many investors and analysts that follow Exact Sciences. I've always appreciated your support and enjoyed interactions. The future of Exact Sciences is extremely bright. I'll now turn the call over to Aaron.

此外，我們發現付款人和醫療系統對 Cologuard 和護理差距計劃的需求更大，通常會在第三季和第四季加速。我們預計第二季的總營收將在 6.77 億美元至 6.97 億美元之間。假設篩檢收入在 5.22 億美元至 5.32 億美元之間，精準腫瘤學收入在 1.55 億美元至 1.65 億美元之間。這是我最後一次精密科學財報電話會議。在過去的 8 年裡，我很榮幸能成為這個團隊的一員。我對我們所取得的成就感到非常自豪。我們共同幫助 Exact Sciences 實現了差異化的成長，擁有強勁的經常性收入、健康的利潤率和穩健的資產負債表。最重要的是，我們已經進行了超過 1700 萬次癌症檢測。我還要感謝眾多關注 Exact Sciences 的投資者和分析師。我一直感謝您的支持並享受互動。精確科學的未來非常光明。我現在將把電話轉給亞倫。

Good afternoon, everyone. I'd like to thank Jeff for his support during my transition. It is an honor to be Exact Sciences next CFO, and I look forward to leading our talented finance team. During my career, I've had the privilege of working for Baxter International and 3M where emphasize growth and operational excellence. I also focused on margin expansion and free generation and played a key role in portfolio management and business development. Exact Sciences is in a prime position to be a global force in the fight against cancer for years to come, and I'm excited about the opportunities in front of us. Together, we'll continue delivering differentiated financial results, all in support of our purpose to help eradicate cancer.

大家下午好。我要感謝傑夫在我過渡期間的支持。我很榮幸成為 Exact Sciences 的下一任財務官，我期待著領導我們才華橫溢的財務團隊。在我的職業生涯中，我有幸在 Baxter International 和 3M 工作，這些公司強調成長和卓越營運。我還專注於利潤擴張和免費生成，並在投資組合管理和業務發展中發揮了關鍵作用。 Exact Sciences 在未來幾年成為對抗癌症的全球力量方面處於領先地位，我對我們面前的機會感到興奮。我們將共同繼續提供差異化的財務業績，所有這些都支持我們幫助根除癌症的目標。

Thanks, Jeff, and thanks, Aaron. Our commercial engine is fueling Cologuard growth through millions of targeted engagements with patients and health care providers. We continue to bring the power of Cologuard of the Cologuard brand to life through new marketing experiences, offering a consistent flow of compelling content to patients ages 45 and older. Marketing investments like these listed Cologuard brand awareness and customer satisfaction to an all-time high in the first quarter. Since the start of last year, 50,000 health care providers chose Cologuard and became new customers to Exact Sciences. Our data show the more time we spend educating these health care providers about the benefits of Cologuard, the more test they order for their patients. Our productivity per customer visits had a record in the first quarter, and we have initiatives underway to drive that even higher. To meet demand among our growing base of ordering providers, we will continue investing in high-impact sales and marketing opportunity. The number of patients do for their next Cologuard test continues to increase, and our growing sales team can help improve the rescreen success rates in this patient population. Health systems and payers are highly motivated to improve screening rates through financial incentives built into quality measure programs. Screening backlogs and colonoscopy wait times continue to increase. In addition, the new quality measure reporting standards evaluate colon cancer screening metrics at the population level rather than through random sampling, increasing the burden for payers on [data report].

謝謝傑夫，謝謝亞倫。我們的商業引擎透過與患者和醫療保健提供者進行數百萬次有針對性的合作，推動 Cologuard 的成長。我們繼續透過新的行銷體驗將 Cologuard 品牌的力量帶入生活，為 45 歲及以上的患者提供持續不斷的引人注目的內容。諸如此類的行銷投資使 Cologuard 的品牌知名度和客戶滿意度在第一季達到了歷史最高水平。自去年年初以來，已有 50,000 家醫療保健提供者選擇了 Cologuard，並成為 Exact Sciences 的新客戶。我們的數據顯示，我們花在教育這些醫療保健提供者有關 Cologuard 益處的時間越多，他們為患者安排的測試就越多。我們的每次客戶訪問生產力在第一季創下了紀錄，並且我們正在採取措施來推動這一目標進一步提高。為了滿足不斷增長的訂購提供者群體的需求，我們將繼續投資於具有高影響力的銷售和行銷機會。接受下一次 Cologuard 測試的患者數量持續增加，我們不斷成長的銷售團隊可以協助提高該患者群體的重新篩檢成功率。衛生系統和付款人非常積極地透過品質衡量計劃中內建的財政激勵措施來提高篩選率。篩檢積壓和大腸鏡檢查等待時間繼續增加。此外，新的品質衡量報告標準在人群層面評估結腸癌篩檢指標，而不是透過隨機抽樣，增加了付款人的[數據報告]負擔。

Cologuard is an ideal solution, and it's emerging as a preferred choice within large organized screening programs run by health systems and payers seeking to close their gaps in care. They're turning to Cologuard because it's in USPSTF guidelines and HEDIS and STARs quality metrics. Cologuard is a highly accurate at-home test that offers 3x more quality credit than the FIT test, which has historically been used within these programs. Our patient compliance engine and the [Exact Nexus] platform, simplify data reporting required in the quality measures to help payers and health systems earn financial incentives. We're also helping health systems and payers unlock efficiencies by leveraging artificial intelligence and their electronic health record systems to automate workflows to determine patient screening history, streamline patient communications and track patient outcomes. This gives health care providers more time to solve real patient [leads.]

Cologuard 是一種理想的解決方案，它正在成為衛生系統和尋求縮小護理差距的付款人運行的大型有組織篩檢計劃的首選。他們轉向 Cologuard，因為它符合 USPSTF 指南以及 HEDIS 和 STAR 品質指標。 Cologuard 是一種高度準確的家庭測試，其品質信用比 FIT 測試高出 3 倍，FIT 測試歷來在這些計劃中使用。我們的患者合規引擎和 [Exact Nexus] 平台簡化了品質措施中所需的數據報告，以幫助付款人和衛生系統獲得經濟誘因。我們還利用人工智慧及其電子健康記錄系統實現工作流程自動化，以確定患者篩檢歷史記錄、簡化患者溝通並追蹤患者治療結果，從而幫助衛生系統和付款人提高效率。這使醫療保健提供者有更多時間來解決真正的患者[線索]。

Our Precision Oncology team delivered outstanding results during the first quarter by testing a record number of people globally with Oncotype DX. We're making great progress towards increasing Oncotype DX adoption internationally with the number of ordering providers expanding by over 20% during the first quarter. There is still a huge unmet need to provide life-changing answers to women who aren't currently being tested, especially in markets like Japan, Italy and Germany. Dedicated efforts are ongoing to broaden our reach and deepen relationships with providers around the world. Building our international presence and team also provides future growth opportunities across our broad portfolio of tests. Over the next 18 months, we're set to launch a range of new tests that will change how cancer is diagnosed, monitored and treated while also helping accelerate Exact Sciences growth. This includes Oncodetect a bespoke MRD test to detect [fragrance] of residual disease earlier than advanced imaging systems can as well as OncoLiquid a blood-based therapy selection test to complement our tissue-based OncoExtra offering. It also includes Cologuard Plus which will be the most efficient noninvasive way to screen for colon cancer.

我們的精準腫瘤學團隊在第一季取得了出色的成果，使用 Oncotype DX 對全球人數進行了創紀錄的測試。我們在提高 Oncotype DX 在國際上的採用率方面取得了巨大進展，第一季訂購供應商的數量增加了 20% 以上。為目前尚未接受測試的女性提供改變生活的答案仍然是一個巨大的未滿足的需求，特別是在日本、義大利和德國等市場。我們正在不斷努力擴大影響範圍並加深與世界各地供應商的關係。建立我們的國際影響力和團隊也為我們廣泛的測試組合提供了未來的成長機會。在接下來的 18 個月中，我們將推出一系列新測試，這些測試將改變癌症的診斷、監測和治療方式，同時幫助加速 Exact Sciences 的發展。其中包括 Oncodetect 一項客製化的 MRD 測試，可比先進成像系統更早檢測殘留疾病的[香味]，以及 OncoLiquid 一項基於血液的治療選擇測試，以補充我們基於組織的 OncoExtra 產品。它還包括 Cologuard Plus，這將是篩檢結腸癌的最有效的非侵入性方法。

The New England Journal of Medicine publication of our pivotal BLUE-C study shows Cologuard Plus raises the performance bar in colon cancer screening. The test achieved 94% overall cancer sensitivity. 43% sensitivity for advanced free cancer (inaudible), including SSLs. 91% specificity when including patients with small polyps and other incidental [finding]. And 93% specificity with no findings on colonoscopy. No other noninvasive approach comes close. We plan to share data from BLUE-C later this year for our blood-based colon cancer screening test which will be powered by [Exact Nexus,] our unique technology platform by our proprietary PCR technology and the commercial infrastructure supporting Cologuard. Exact Sciences has deep relationships with over 350,000 health care providers and a powerful -- a powerful colon cancer screening database. These unique advantages give us the opportunity to identify patients who refuse standard of care screening and offer our blood test as a second-line option at a very reasonable cost.

《新英格蘭醫學雜誌》發表的我們的關鍵 BLUE-C 研究表明 Cologuard Plus 提高了結腸癌篩檢的表現標準。該測試的整體癌症敏感性達到 94%。對於晚期遊離癌症（聽不清楚），包括 SSL，敏感性為 43%。當包括小息肉和其他偶然事件的患者時，特異性為 91% [發現]。特異性為 93%，大腸鏡檢查未發現任何發現。沒有其他非侵入性方法可以與之相提並論。我們計劃在今年稍後分享來自BLUE-C 的數據，用於基於血液的結腸癌篩檢測試，該測試將由我們獨特的技術平台[Exact Nexus] 提供支持，該平台由我們專有的PCR 技術和支援Cologuard 的商業基礎設施提供支援。 Exact Sciences 與超過 350,000 家醫療保健提供者建立了深厚的關係，並擁有強大的結腸癌篩檢資料庫。這些獨特的優勢使我們有機會識別拒絕標準護理篩檢的患者，並以非常合理的成本提供我們的血液檢測作為二線選擇。

We have built an unrivaled foundation to engage patients and health care providers, and we are set to gain momentum with each new test added to this platform. We're using this platform to help eradicate cancer by preventing, detecting it earlier and guiding personalized treatment. Cologuard, Oncotype DX and our pipeline of life-changing diagnostics will power years of double-digit growth and continued profitability, helping us achieve our purpose.

我們已經建立了一個無與倫比的基礎來吸引患者和醫療保健提供者，我們將透過添加到該平台的每項新測試來獲得動力。我們利用這個平台透過預防、早期檢測和指導個人化治療來幫助根除癌症。 Cologuard、Oncotype DX 和我們改變生活的診斷產品系列將推動多年的兩位數成長和持續獲利能力，幫助我們實現我們的目標。

Before we turn to Q&A, I'd like to thank Jeff for his many contributions to Exact Sciences over the last 8 years. He's been an invaluable business partner and leader. We'll miss him once he departs. We wish him all the best as he enjoys well-deserved time off with his family. We're now happy to take questions.

在我們進行問答之前，我要感謝 Jeff 在過去 8 年裡對 Exact Sciences 的許多貢獻。他是一位非常寶貴的商業夥伴和領導者。他離開後我們會想念他的。我們祝他一切順利，因為他與家人一起享受當之無愧的假期。我們現在很樂意回答問題。

(Operator Instructions) Your first question comes from Catherine Schulte with Baird.

（操作員說明）您的第一個問題來自 Baird 的 Catherine Schulte。

Congrats to Jeff. You will certainly be missed. Starting with Cologuard, Screening revenue grew 7% in the first quarter. Guidance implies more like 16% for the full year, kind of mid-teens in the second quarter and over 20% in the back half. So can you just talk through what gives you confidence in that growth outlook and excites you about the Cologuard growth story from here? And if I could just squeeze one in on profitability. And you saw adjusted EBITDA decline year-over-year in the first quarter. So if you could just talk through the drivers there, that would be great.

恭喜傑夫。你一定會被想念的。從 Cologuard 開始，第一季 Screening 營收成長了 7%。指引意味著全年的成長率約為 16%，第二季約為 10%左右，下半年則超過 20%。那麼，您能否在此談談是什麼讓您對成長前景充滿信心，並讓您對 Cologuard 的成長故事感到興奮？如果我能在獲利能力上擠一擠就好了。第一季調整後的 EBITDA 年減。因此，如果您能與那裡的司機交談，那就太好了。

Sure. Why don't I take the first part and hand it over to Jeff afterwards. Here's why we're excited about this year. The size of the opportunity remains enormous. 16 million people in the U.S. are not up-to-date with colon cancer screening. And our customer relationships have broadened and deepened deepen immeasurably over the last year. There are over 330 health systems today that rely on electronic ordering and advanced tools that we provide -- are really our consulting services that we provide around IT patients. There are over 2 million people today who are due for a rescreen. There will be 400,000 new patients due in Q2 alone. Payers, their gap closure programs will get into them, but that is a new and significant growth area. The biggest impact will be in Q4. And then Q3, we'll start to see that impact.

當然。我為什麼不先把第一部分交給傑夫呢？這就是我們對今年感到興奮的原因。機會的規模仍然是巨大的。美國有 1600 萬人沒有接受最新的大腸癌篩檢。去年，我們的客戶關係不斷擴大和加深。如今有超過 330 個衛生系統依賴我們提供的電子訂購和先進工具——實際上是我們圍繞 IT 患者提供的諮詢服務。今天有超過 200 萬人需要重新篩檢。光是第二季就有 40 萬名新患者。付款人，他們的差距縮小計劃將進入其中，但這是一個新的、重要的成長領域。最大的影響將出現在第四季。然後第三季度，我們將開始看到這種影響。

The power of the commercial team, Everett will get into talking about that -- the [Exact Nexus] platform, our customer service, customer experience and IT has been a differentiator for us with health systems and payers. And clearly making an impact with patients. And then the power of our brand, it hit an all-time high in Q1 in terms of brand awareness, the positive reaction to the creative digital and in-line television commercials and social media engagement we've had. So all of these things are drivers. Yes, we had a tough comp relative to Q1. We also -- we turned down our sales and marketing investments, as you know, over the last year and really over the last couple of years, while we saw about approaching $1 billion of growth. And the truth is we probably turned that down a little bit too much. We recognize that at the back end of last year.

Everett 將談論商業團隊的力量——[Exact Nexus] 平台、我們的客戶服務、客戶體驗和 IT 一直是我們與醫療系統和付款人的差異化因素。並明顯對患者產生影響。然後是我們品牌的力量，在品牌知名度、對創意數字和線上電視廣告的積極反應以及我們的社交媒體參與度方面，它在第一季度創下了歷史新高。所以所有這些都是驅動因素。是的，相對於第一季度，我們的比賽比較艱難。如你所知，我們在過去一年甚至在過去幾年都拒絕了銷售和行銷投資，而我們看到了接近 10 億美元的成長。事實上，我們可能拒絕太多了。我們在去年年底就意識到了這一點。

And starting in Q1, we increased our marketing investments. We -- as of now, we have a complement of new primary care sales reps who are hitting the ground now. We've already seen the impact from the marketing investment in terms of accelerating growth. So that typically takes 3 to 6 months. And we're seeing that, plus we are adding a significant contingent of new reps around the country, and we expect to see additional growth from those reps. Our overall spend will still be less in sales and marketing in '24 than it was in '22. We know this added firepower will have a positive impact. And one thing that we always look at is the promotional response to (inaudible). The number of test orders that result from calling on deciles of physicians. And it's clear the more time, the more frequently our reps call on an office in a position or a nurse or physician assistant, you see a straight line increase with no flattening from 0 to 6 calls per quarter. That gives us confidence that by adding reps, we will see is. If not. You will see an increase in the total number of test orders. So I'll pause there, we'll be able to get into a lot of these areas Everett is here. And Jeff, why don't you take the profitability?

從第一季開始，我們增加了行銷投資。截至目前，我們已經有一批新的初級保健銷售代表正在上崗。我們已經看到了行銷投資對加速成長的影響。所以這通常需要 3 到 6 個月的時間。我們看到了這一點，而且我們正在全國範圍內增加大量新代表，我們預計這些代表將進一步成長。 24 年我們在銷售和行銷方面的整體支出仍將少於 22 年。我們知道增加的火力將會產生正面的影響。我們始終關注的一件事是促銷反應（聽不清楚）。拜訪十分之一的醫生而產生的測試訂單數量。很明顯，我們的代表致電某個職位的辦公室或護士或醫師助理的時間越長、越頻繁，您就會看到直線增加，沒有平坦化，從每季度 0 次增加到 6 次。這讓我們相信，透過增加代表，我們將會看到這一點。如果不行。您將看到測試訂單總數增加。所以我會在這裡暫停，我們將能夠進入埃弗雷特在這裡的許多領域。傑夫，為什麼不拿走獲利呢？

Yes. And just to add to -- with remarks on the comparison. As I said in my remarks, we did have a really hard compare. If you look at the 2-year stacked comp. Q1 was up 24%. When you think back to last year, part of why the way whole first half was so strong is because of late in '22, we made some pretty significant upgrades to both our billing systems and our patient compliance systems. That led to a bolus of high-margin revenue, really consider this really out-of-period revenue that helped out the first half of last year. Obviously, that's not going to keep repeating. So we do faced a really difficult compare in the first half. (inaudible) you walked through some of the comparisons. In the second half, conversions do get much easier, and we do expect 20% growth plus in the second half. The reason I bring that up is also from a profitability standpoint, that comparison help revenue and profits because when that revenue came in at it came in at a very high margin.

是的。只是補充一下——對比較進行評論。正如我在演講中所說，我們確實進行了一次非常艱難的比較。如果你看一下 2 年的堆積補償。第一季成長 24%。當你回想去年時，整個上半年如此強勁的部分原因是在 22 年末，我們對計費系統和病患合規系統進行了一些相當重大的升級。這帶來了大量的高利潤收入，真的考慮一下這確實是去年上半年的期外收入。顯然，這種情況不會繼續重複。所以我們在上半場確實面臨非常困難的比較。 （聽不清楚）您做了一些比較。下半年，轉換確實變得更加容易，我們預計下半年成長率將超過 20%。我提出這一點的原因也是從獲利能力的角度來看，這種比較有助於收入和利潤，因為當收入達到時，它的利潤率非常高。

So when you look at Q1, we expect Q1 in a normal year, a Q1 profitability will be the lowest of the year. We expect both -- the latest revenue growth and the highest OpEx as a percent of revenue throughout the year, I expect faster growth and lower OpEx as a percent of revenue. Again, the comparison is a bit easier. When you look at gross margin in Q1, they were a bit lighter in part because of the automation we brought on. We had a huge step forward in automation. The team did a nice job bringing that online. That will help margins improve over time. In the short term, that added some fixed cost that weighed our margins a bit. We also have this care gap initiative that we've talked about bring the source of revenue. It is adding significant EBITDA dollars, but it does come at a slightly lower gross margin that we'll work our way through, but that did weigh in Q1 a bit as well.

因此，當你看第一季時，我們預計在正常年份第一季度，第一季的獲利能力將是一年中最低的。我們預計全年的最新收入成長和最高營運支出佔收入的百分比，我預期成長更快，營運支出佔收入的百分比更低。同樣，比較也更容易一些。當你看第一季的毛利率時，你會發現它們的毛利率有點​​低，部分原因是我們引入了自動化。我們在自動化方面向前邁出了一大步。該團隊在將其上線方面做得很好。隨著時間的推移，這將有助於提高利潤率。從短期來看，這增加了一些固定成本，稍微影響了我們的利潤。我們還有這個護理差距計劃，我們已經討論過它可以帶來收入來源。它顯著增加了 EBITDA 美元，但毛利率確實略低，我們將努力解決這個問題，但這確實對第一季造成了一些影響。

Our next question comes from Vijay Kumar with Evercore ISI.

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

Jeff, wishing you all the best. My one question here, Kevin, perhaps on what is the -- this comps that you didn't mention that are different ways of looking at it, is the right way to look at this is on a CAGR basis versus pre-pandemic level? Or it seems like it's pretty consistent when we do the CAGR math in related to that. There's been some noise on the competitive landscape. I think one of the stool-based companies got an approval, an FDA approval. I'm curious on your thoughts on the competitive landscape?

傑夫，祝你一切順利。凱文，我的一個問題也許是關於什麼是——你沒有提到的這個比較是不同的看待它的方式，正確的方式是基於複合年增長率與大流行前的水平來看待這個問題嗎？或者當我們進行與此相關的複合年增長率數學時，它似乎非常一致。競爭格局中出現了一些噪音。我認為其中一家基於糞便的公司獲得了 FDA 的批准。我很好奇您對競爭格局的看法？

Sure. Let me go back to Cologuard and Cologuard Plus. The -- both tests offer performance that is unequal to -- that is superior to the FIT test and the performance of the studies that we ran were large studies with a significant number of cancers -- cancer patients across a broad age range. And Cologuard Plus advance the standard of care over Cologuard. Our specialized teams make sure that health care providers are aware of the broad studies that support Cologuard. And we have the ability to deliver that in a very clear way, plus the strength of our platforms and all of that. But now you've got to go to -- remember, anybody who brings a new screening test to market. One of the key things that they need to do to have that test be relevant is to get into the quality measures. The path to getting into the quality measures is a very long one. We think a new test, and this excludes Cologuard Plus because Cologuard Plus, like Cologuard is already in the quality measures, we've already -- all that work has been done.

當然。讓我回到 Cologuard 和 Cologuard Plus。這兩項測試的表現均優於 FIT 測試，而且我們進行的研究的表現是對大量癌症患者進行的大型研究，涵蓋了廣泛的年齡範圍。 Cologuard Plus 比 Cologuard 提高了護理標準。我們的專業團隊確保醫療保健提供者了解支持 Cologuard 的廣泛研究。我們有能力以非常明確的方式實現這一點，再加上我們平台的實力等等。但現在你必須去——記住，任何將新的篩檢測試推向市場的人。為了使測試具有相關性，他們需要做的關鍵事情之一是進入品質衡量標準。進入品質衡量標準的道路是漫長的。我們考慮進行一項新測試，這不包括 Cologuard Plus，因為 Cologuard Plus 與 Cologuard 一樣已經納入品質衡量標準中，我們已經完成了所有工作。

New tests coming online need multiple studies -- needs broad studies. You need to study the Medicare population in a broad way and may get all the way through USPSTF, which is the trigger for the quality measures. Well, USPSTF, our best guess is 2027 is the next update and then it would be '28 or '29 for the quality measures. We -- as you know, we have a patent infringement and false advertising suit against an aspiring new entrant into the market. We won't be talking about that case. We will, of course, defend our intellectual property aggressively. And Jeff, why don't you take the CAGR question?

上線的新測試需要多項研究——需要廣泛的研究。您需要廣泛地研究 Medicare 人群，並可能一路通過 USPSTF，這是品質措施的觸發因素。好吧，USPSTF，我們最好的猜測是 2027 年是下一次更新，然後品質衡量標準將是「28」或「29」。如您所知，我們對一個有抱負的市場新進業者提起了專利侵權和虛假廣告訴訟。我們不會談論那個案子。當然，我們將積極捍衛我們的智慧財產權。傑夫，為什麼不回答複合年增長率的問題呢？

Sure. Vijay, on the 2-year stack. I do think it's informative to look at the 2-year growth rates in this case because of the unusual growth we had last year. It is informative. And to add some more color on it, if you look at some of the major growth drivers, like we've talked a lot about rescreens in the 45. If you look at that 2-year stack in the first quarter, both of rescreens and that 45 to 49 younger age group both grew over 40% on a 2-year stack, and that's 50-plus age group grew consistently over 10%. So that gives us confidence that what we're seeing here is primarily a comparison issue. And again, when you look at the back half, the comps do get easier. So in addition to what Kevin talked about, the investments that we're making will help accelerate growth after last year leaving some growth on the table through underspending.

當然。 Vijay，在 2 年堆疊中。我確實認為，在這種情況下查看兩年成長率是很有參考價值的，因為我們去年的成長不尋常。它內容豐富。為了增加更多的色彩，如果你看看一些主要的成長驅動因素，就像我們在45 年中談論了很多關於重新篩選的事情一樣。重新篩選45 至 49 歲的年輕族群在兩年內成長均超過 40%，而 50 歲以上的年齡族群持續成長超過 10%。因此，這讓我們相信我們在這裡看到的主要是一個比較問題。再說一次，當你看後半部分時，比賽確實變得更容易了。因此，除了凱文談到的內容之外，我們正在進行的投資將有助於加速成長，因為去年支出不足導致了一些成長。

Our next question comes from Doug Schenkel with Wolfe Research.

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

Kevin, thanks for all the comments on the market opportunity, which remains large and unpenetrated or underpenetrated. It's helpful to hear about your awareness building efforts and the progress you're making. And I think we recognize that the comparison was tough here. That said, I do think recognizing you're cutting things a smidge different or at least not giving us quite as much information as you told us to be prepared for. It does seem like orders per practice dropped relative to what we saw maybe in every quarter last year. And I think it's fair to say that folks expected the Cologuard number to be a little bit better. So I just want to make sure that we understand a few things. Like one, was there any transitory impact? Was there something that you maybe saw that was worse than expected when it came to respiratory? Or anything else that might have been transitory? Two, was there anything different in terms of capturing reorder opportunities, maybe more of those lagged into the following quarter? And then I guess kind of building off of this, when would you expect reps to make an impact? Is there still going to be a 6- to 9-month lag? Or is there something different here that can get you a quicker return on investment? All of this is meant to just get to the question of -- based on what you're seeing in terms of trends based on what we saw in the quarter, more importantly, as we look longer term and think about the opportunity, the progress you're making with awareness all of those good things. How do we get comfortable that Cologuard for not just this year, but for the foreseeable future is a double-digit growth franchise?

凱文，感謝您對市場機會的所有評論，該市場機會仍然很大且尚未滲透或滲透不足。了解您在提高意識方面所做的努力以及所取得的進展會很有幫助。我認為我們認識到這裡的比較很困難。也就是說，我確實認為認識到您正在對事情進行一些不同的處理，或者至少沒有向我們提供您告訴我們要做好準備的那麼多資訊。與我們去年每季看到的情況相比，每次診所的訂單似乎確實有所下降。我認為可以公平地說，人們期望 Cologuard 的數字會好一點。所以我只想確保我們了解一些事情。例如，有沒有任何暫時的影響？在呼吸方面，您是否曾經看過比預期更糟糕的情況？或其他可能是暫時的事情？第二，在抓住再訂購機會方面有什麼不同嗎？然後我想以此為基礎，您預期代表什麼時候會產生影響？還會有 6 到 9 個月的延遲嗎？或者這裡有什麼不同的東西可以讓您更快獲得投資回報？所有這一切都是為了解決這個問題——基於你所看到的趨勢，基於我們在本季度看到的情況，更重要的是，當我們著眼長遠並思考機會和進展時你正在帶著意識去創造所有這些美好的事物。我們如何讓 Cologuard 不僅在今年而且在可預見的未來都保持兩位數的成長？

Yes. Well, let me start by seeing despite the items you raised, I've never been more excited or confident about Cologuard. And one thing that we learned from turning down the sales and marketing spend is that -- for 6 months, you'll see continued progress. I mean -- and we saw that last year. You can't go forever, though with the brand is large and it's impactful as Cologuard with the size of the investment that we were making. And the good news is we have the data and analytics to back that up. We made the investments in the first quarter. And as we sit here today, without the addition of all of the salespeople in the first quarter, most of them are coming online right now. We've already seen a return to the growth that we expected.

是的。好吧，首先讓我看到，儘管您提出了這些問題，但我對 Cologuard 從未如此興奮或自信。我們從拒絕銷售和行銷支出中學到的一件事是，在 6 個月內，您將看到持續的進步。我的意思是——我們去年就看到了這一點。儘管 Cologuard 品牌很大，而且我們的投資規模也很大，但你不可能永遠這樣下去。好消息是我們有數據和分析來支持這一點。我們在第一季進行了投資。當我們今天坐在這裡時，在第一季沒有增加所有銷售人員的情況下，他們中的大多數人現在都已經上線了。我們已經看到了我們預期的成長恢復。

So we have confidence that we're going to be able to deliver on this full year. And the other thing is this and we'll get into this in more depth. Health systems -- there are dozens and dozens and dozens of health systems who have come to us and say, please help us improve our colon cancer screening rates. With gap closure programs, with helping them optimize their EHR platforms, Epic, et cetera, to use population health tools to get more people screened. That is at a rate we have never seen. And then these payer programs are significant programs. Last year was the first year we really saw that demand being generated and just kudos to the team who's worked so hard to deliver there. And -- we already have strong insight into what is happening with those programs. So when we say we expect those programs have an impact in Q3 and Q4, we have line of sight into that. That's not guess work. So Jeff, do you want to add color?

因此，我們有信心能夠實現全年目標。另一件事是這個，我們將更深入地討論這個問題。衛生系統－有數十個衛生系統來找我們說，請幫助我們提高大腸癌篩檢率。透過彌補差距計劃，幫助他們優化 EHR 平台、Epic 等，利用人口健康工具讓更多人接受篩檢。這是我們從未見過的速度。這些付款人計劃都是重要的計劃。去年是我們真正看到需求產生的第一年，我們對辛勤工作的團隊表示敬意。而且──我們已經對這些計劃的進展有了深入的了解。因此，當我們說我們預計這些計劃會在第三季和第四季產生影響時，我們已經看到了這一點。這不是猜測工作。那麼傑夫，你想添加顏色嗎？

Sure. Yes. Doug, you asked initially on the reorder rate. I know you like to do the math on this. The pool of doctors has grown -- order providers has grown so large over 350,000 now. They're looking at that entire base for reordering that and I think it's misleading. We intend to often look at the different cohorts of doctors based on when they first ordered. So go back and look at the cohort, the first orders in 14, 15 unit by year. And what I'll say is that every cohort of providers based on kind of when they first ordered continues to climb. We have seen no slowing down. Kevin talked about that promotion response curve. It is up and to the right. The more time we spend educating the doctor, the more they order. And overall market share still at this point, we're about 12% now. That's going to continue climbing for years. You get a little misleading when that pool of 350,000 providers. Some of those have since retired. So that puts a little downward pressure on the maths you're doing, but the underlying trends there are very strong.

當然。是的。道格，您最初詢問了重新訂購率。我知道你喜歡對此進行數學計算。醫生隊伍不斷壯大——訂單提供者現已超過 35 萬名。他們正在考慮整個基地來重新排序，我認為這是誤導性的。我們打算經常根據不同的醫師群體第一次下醫囑的時間來觀察他們。所以回頭看看這個隊列，第一批訂單每年有 14、15 個單位。我要說的是，基於首次訂購時間的每組供應商都在繼續攀升。我們沒有看到放緩的跡象。凱文談到了晉升反應曲線。它位於右側上方。我們花在教育醫生的時間越多，他們的訂單就越多。目前整體市佔率仍是 12% 左右。這一數字還將持續上升數年。當這個包含 350,000 個提供者的池中時，你會有點誤導。其中一些已經退休。因此，這給你正在做的數學帶來了一點下行壓力，但潛在的趨勢非常強勁。

Your second point on transitory impact. Yes, this year was a more normal flu year. A little bit more kind of flu into like January, February last year, flu was almost nonexistent, and it was really early. So this year, I would say it was more of a typical trend. When you look Q4 to Q1, Cologuard was down low single digits. That's more of a typical quarter-to-quarter progression that we got last year. Again, last year, '22 Q4 to Q1 of '23, we were up. That was unusual. You asked on -- I think Kevin covered the question on [ripped impacts.] On rescreens. The pool of patients becoming eligible grows by 1/3 this year. It goes from 1.2 million last year to 1.6 million this year. So it's a significant growth driver for us. It's maybe the biggest growth driver this year. And our success rate of getting patients to come back to Cologuard does continue to grow.

關於暫時性影響的第二點。是的，今年是比較正常的流感年。流感有點多，像是去年一月、二月，流感幾乎不存在，而且真的很早。所以今年，我想說這更像是典型趨勢。從第四季到第一季來看，Cologuard 的業績下降了個位數。這更像是我們去年獲得的典型季度環比成長。同樣，去年，22 年第 4 季到 23 年第 1 季度，我們的表現有所上升。這很不尋常。你問過——我想凱文在重屏上談到了關於[撕裂影響]的問題。今年符合資格的患者數量增加了 1/3。從去年的120萬增加到今年的160萬。因此，這對我們來說是一個重要的成長動力。這可能是今年最大的成長動力。我們讓患者回到 Cologuard 的成功率確實在持續成長。

When you look down on a quarter-by-quarter basis, the pool of patients becoming eligible in Q2 is significantly larger than Q1. This is just the way it works when you look back at the pool from 3 years ago. So rescreens will be a huge driver. It's going to be a bigger driver in Q2 and beyond than it was in Q1.

當您按季度查看時，您會發現第二季度符合資格的患者數量明顯多於第一季。當你回顧三年前的泳池時，這就是它的運作方式。因此，重新篩選將是一個巨大的推動力。與第一季相比，第二季及以後的成長將成為更大的推動力。

And if I could just add a little bit more color, Doug. This is Everett to the rep impact and time line. A couple of things to that. First of all, we were very intentional to hire experienced reps that have deep relationships already existing in primary care. So while they're new to Exact Sciences, they are not new to primary care and selling in the space. And then the second thing is, we were, again, intentional to ensure that they know the geography. They have deep relationships already. These new reps do. So Kevin said they're in training now. They'll be in the field next week, and I'm confident that they'll hit the ground running. And because of our intentional nature. I think they're going to have a quicker impact than 6 months. I think it will be more 3 or 4 months.

如果我可以添加一點顏色的話，道格。這是埃弗里特的代表影響和時間表。有幾件事。首先，我們非常有意聘請經驗豐富的代表，他們在初級保健領域已經存在深厚的關係。因此，雖然他們是精確科學領域的新手，但他們對該領域的初級保健和銷售並不陌生。第二件事是，我們再次有意確保他們了解地理。他們已經有很深的關係了。這些新代表做到了。凱文說他們現在正在訓練。他們將於下週上場，我相信他們會立即投入工作。因為我們的故意性質。我認為它們將比 6 個月產生更快的影響。我認為還要3、4個月。

Your next question comes from Patrick Donnelly with Citi.

您的下一個問題來自花旗集團的派崔克唐納利。

Obviously, a lot on the kind of reps -- rep adding side. If I can just continue to add on that. Kevin, I guess how do you think about potential revenue upside flowing through? I mean, obviously, last year, when you guys were able to raise the revenue targets, your EBITDA seemed to go up by more every single time. Do you feel like now that you've added these reps and the cost base is set here if you do see revenue upside, is the flow-through there are going to be pretty attractive? Or does additional costs come back? You've obviously mentioned a few times investing in these high-impact sales marketing opportunities. So do you see more costs coming if there is revenue upside? Or are we in a pretty good spot here? And then I don't know if I missed it, but just the magnitude of the rep adds in terms of head count would be helpful if you could break that out.

顯然，很多都是在增加代表方面。如果我可以繼續補充的話。凱文，我猜你如何看待潛在的收入成長？我的意思是，顯然，去年，當你們能夠提高收入目標時，你們的 EBITDA 似乎每次都會增加更多。您是否覺得現在您已經添加了這些代表並且成本基礎已在此處設定，如果您確實看到收入上升，那裡的流量是否會非常有吸引力？或者額外的成本會回來嗎？您顯然已經多次提到投資這些具有高影響力的銷售行銷機會。那麼，如果收入上升，您是否認為會產生更多成本？或者我們現在處於一個非常好的位置？然後我不知道我是否錯過了它，但如果你能打破這一點，那麼就人數而言，代表的增加量就會很有幫助。

Yes. We're not -- we are staying away from indicating the number of reps we are adding. But it is -- the math around this, it's pretty clear. You get a ton of leverage by adding these reps. So if there is a -- you have a fixed amount of cost that you're adding. For example, we're not adding new area managers here, our current area managers roughly end up with about one new rep per territory that they oversee. And -- the leverage is incredible. I mean what we have seen is the productivity in terms of the number of Cologuard orders per call that our sales force makes continues to increase year-over-year and for that matter, quarter-over-quarter. So the productivity here is going to be significant. And we want them to make sure that investors know we are doing this as we took a pause for the first time in 10 years in terms of the total number of reps promoting Cologuard.

是的。我們不會－我們不會顯示我們所增加的代表次數。但事實是——圍繞這個問題的數學計算非常清楚。透過添加這些代表，您將獲得巨大的影響力。因此，如果存在 - 您要添加固定數量的成本。例如，我們不會在這裡增加新的區域經理，我們目前的區域經理最終大致會為他們所監管的每個地區增加一名新代表。而且——槓桿作用令人難以置信。我的意思是，我們所看到的是，我們的銷售人員每次致電 Cologuard 訂單數量方面的生產力持續逐年增長，就此而言，逐季度持續增長。因此這裡的生產力將會非常顯著。我們希望他們確保投資者知道我們正在這樣做，因為我們 10 年來首次暫停了推廣 Cologuard 的代表總數。

And what we're saying is, yes, we probably shouldn't have taken that pause. We probably should have kept -- to keep adding because of the size of the opportunity. And so the leverage that we will continue to get over time by thoughtfully adding reps, we expect more reps, more revenue. Everett?

我們想說的是，是的，我們可能不應該暫停。由於機會的大小，我們可能應該繼續增加。因此，隨著時間的推移，我們將透過深思熟慮地增加代表來繼續獲得影響力，我們期望更多的代表，更多的收入。埃弗里特？

Yes. In addition to that, it was said earlier that there's 50,000 new providers since the beginning of 2023. And we know, based on what Kevin said, the more frequency that we have with not only our existing footprint, but the 50,000 new providers -- man, there's going to be so much leverage that our reps can generate with getting access into those offices. So we're excited. Our goal is in commercial is simple is to drive our existing footprint and to continue to create new providers writing Cologuard first line.

是的。除此之外，早些時候據說自 2023 年初以來有 50,000 個新提供者。夥計，我們的代表透過進入這些辦公室可以產生很大的影響力。所以我們很興奮。我們的商業目標很簡單，就是推動我們現有的足跡，並繼續創造新的供應商，編寫 Cologuard 第一線產品。

So just to add a little more color. This is Jeff. We expect P&L leverage throughout every line in the P&L this year. It won't be the same kind of leverage we had last year, then we had like 16 points of improvement. We are tracking ahead of where we expect to be for our long-term 2027 guidance there. So we feel very good about hitting those numbers. When you add new reps, though, again, leverage flows through very nicely. You think of gross -- excellent gross margin, 80% plus and very strong throughout the P&L. So still good pace of leverage improvement from here.

所以只是添加一點顏色。這是傑夫。我們預計今年損益表中的每條線都存在損益槓桿。這不會是我們去年所擁有的那種槓桿，那時我們有大約 16 個點的改進。我們正在追蹤 2027 年長期指導的預期目標。所以我們對達到這些數字感到非常高興。然而，當你加入新的代表時，槓桿作用就會非常好地流動。你會想到毛利率——出色的毛利率，超過 80%，整個損益表都非常強勁。因此，從這裡開始，槓桿率改善的步伐仍然良好。

Patrick, you did mention the upside. I think you were tieing that to the rep investment. I would just say that when we contemplated guidance to start the year, we did assume these investments being made. So I wouldn't assume any growth we get from the reps and market that we're adding. That's not above and beyond the guidance. That's already baked in the guidance.

派崔克，你確實提到了好處。我認為你將其與代表投資聯繫起來。我只想說，當我們考慮年初的指導時，我們確實假設正在進行這些投資。因此，我不會假設我們從增加的代表和市場中獲得任何成長。這並不超出指導範圍。這已經在指南中體現出來了。

Your next question comes from Dan Arias with Stifel.

您的下一個問題來自 Stifel 的 Dan Arias。

Kevin, just looking at the presentation that you guys had teed up for DDW, One of them relates to helping docs work through colonoscopy backlog, and then one relates to FIT. So two quick ones, if I can. Where do you think the collective backlog for colonoscopy is at this point? And then on FIT, do you have any data from the field on just how you're doing converting FIT users? Is that success improving over time?

Kevin，剛剛來看看你們為 DDW 準備的演示文稿，其中一項涉及幫助醫生處理大腸鏡檢查積壓工作，然後一項涉及 FIT。如果可以的話，快點說兩句吧。您認為目前大腸鏡檢查的集體積壓情況在哪裡？那麼在 FIT 方面，您是否有關於如何轉換 FIT 用戶的現場數據？隨著時間的推移，這種成功是否會有所改善？

Yes. So what we're seeing is it varies around the country. But let's say, around 3- to 6-month backlog -- and we have seen that tick up over the last 3 months, actually. It's not a surprise. We have a fixed colonoscopy capacity in the U.S. of about 5 million to 6 million screening colonoscopies a year and maybe about 6-plus million diagnostic colonoscopies. It's not changing because on average, you get about net a couple of hundred new GIs every year in the U.S. And Cologuard is taking share from FIT. So what you're seeing is Cologuard is mainly getting people who have never been screened. They're getting people who have been screened with Cologuard in the past and they're converting FIT. And colonoscopy utilization is staying the same. It's just not going to increase. And so the colonoscopy backlogs aren't going to screen. My wife is overdue for colon cancer screening. She is -- has family risk. She's high risk because of a family history.

是的。所以我們看到的是全國各地的情況各不相同。但比方說，大約有 3 到 6 個月的積壓——實際上，我們已經看到過去 3 個月積壓的情況增加。這並不奇怪。我們在美國擁有固定的大腸鏡檢查能力，每年大約進行 500 萬到 600 萬次大腸鏡篩檢，可能還有大約 6 萬多次診斷性大腸鏡檢查。它並沒有改變，因為平均而言，美國每年淨增加數百個新地理標誌，而 Cologuard 正在從 FIT 手中奪取份額。所以你看到的是 Cologuard 主要吸引的是從未接受過篩檢的人。他們正在招募過去接受過 Cologuard 篩檢的人，並開始轉為 FIT。大腸鏡檢查的使用率保持不變。它只是不會增加。因此，積壓的大腸鏡檢查不會被篩檢。我妻子的大腸癌篩檢已逾期。她有家庭風險。由於家族史，她的風險很高。

And her backlog is 9 to 12 months, her wait time, it's 9 to 12 months to get screened. She is at, high risk. So we are seeing that all over the country. There are some parts of the country in New York, where you can get in pretty quickly. But that's not true in most parts of the country. Everett, do you want to provide any color?

她的積壓是 9 到 12 個月，她的等待時間是 9 到 12 個月才能被篩檢。她處於高風險之中。所以我們在全國各地都看到這種情況。紐約州的某些地區您可以很快到達。但在該國大部分地區並非如此。 Everett，你想提供任何顏色嗎？

No. Thanks, Kevin. I mean through my travels, I've been in the field and I've seen this colonoscopy backlog situation, and it is real. It's not going away. As one example, we have hundreds of these examples, but one example is of a health system in Florida where they had 800 patients of average risk with a 8-month backlog. And we met with their C-Suite, they, along with us, implemented an alert that went to all their positions and has alerted their positions of a patient that came in, they were due for screening, and that alert stated that for that patient that they would get Cologuard first line. And that's a good example of our partnership, making it easy, making it easy to be electronically ordered and have a partnership with the health system to get their patients screened and not have a 6-month, 8-month, 12-month backlog, and you're seeing these all over the country.

不，謝謝，凱文。我的意思是，透過我的旅行，我一直在現場，我看到了結腸鏡檢查積壓的情況，這是真實的。它不會消失。舉個例子，我們有數百個這樣的例子，但其中一個例子是佛羅裡達州的一個衛生系統，那裡有 800 名處於平均風險的患者，積壓了 8 個月。我們會見了他們的最高管理層，他們和我們一起實施了一個警報，該警報發送到他們的所有職位，並提醒他們的位置有一名進來的患者，他們應該接受篩檢，並且該警報指出，對於該患者他們將獲得 Cologuard 第一線。這是我們合作關係的一個很好的例子，讓一切變得簡單，讓電子訂購變得容易，並與衛生系統建立合作夥伴關係，讓他們的患者得到篩檢，而不會出現6 個月、8 個月、12 個月的積壓，你在全國各地都可以看到這些。

Your next question comes from Jack Meehan with Nephron Research.

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

Kevin, I think you mentioned the colon blood data from BLUE-C coming later this year. I was wondering if there's any more precision you could provide around the timing there and just update us on the benchmark you're looking for in terms of what would mark success?

Kevin，我想你提到了今年稍後來自 BLUE-C 的結腸血液數據。我想知道您是否可以提供更精確的時間安排，並向我們更新您正在尋找的衡量成功的基準？

Sure. We had planned to generate that data in the summer that is now more likely to be in the fall, given the readouts that we have recently seen. We have the luxury of time and we've decided to take a little bit more time and run about 3,000 more samples -- other samples with the test and make sure that we collect more data on the specificity and the cutoff to make sure the test is as robust as possible. So that -- we plan to test it with several thousand prospectively collected samples in that extra time that we have. And we think that's the right thing to do. But let's position where we think our blood test is going to be. We think that our blood test is probably going to perform similar to maybe better than the other readouts that you have seen in the field.

當然。鑑於我們最近看到的讀數，我們原計劃在夏季產生這些數據，現在更有可能在秋季產生。我們有充裕的時間，我們決定多花一點時間，再運行大約 3,000 個樣本 - 其他樣本進行測試，並確保我們收集更多有關特異性和截止值的數據，以確保測試盡可能堅固。因此，我們計劃在額外的時間內以數千個前瞻性收集的樣本進行測試。我們認為這是正確的做法。但讓我們把血液檢查放在我們認為應該進行的位置。我們認為我們的血液檢查的表現可能與您在現場看到的其他讀數相似，甚至更好。

We've done 7 case control studies, and you see the greatest amount of variability around pre-cancer detection, not around specificity or cancer detection. So that, to me, is the question mark. But at the end of the day, we're kind of assuming performance like we have seen. And then the thing to remember is that our test is a PCR test or it's a -- our proprietary version of PCR, which is a very low cost per test approach. And so when we have all the data about the people who have refused a frontline screening test. We have the ability to work with the providers, the health systems, the payers to get those people screened with our CRC Blood Test and then to try to encourage them to switch to Cologuard in the year after that. So that -- we think this is a meaningful opportunity for us, and we're clearly the best situated to deliver on that. Especially when you look at Medicare today, Medicare Part B is only about -- it's under 20% of our overall opportunity, and Medicare Advantage is probably 22%. It's more than half of all the Medicare patients. With the lower cost test, we have the ability to go in contract with those Medicare advantage plans with a clear plan to switch those patients to a test that gets a quality measure credit of 3 years, which is what they care about. So we're excited about this opportunity, and we think it can lead to getting more people screened and also drive growth at Exact.

我們已經完成了 7 項病例對照研究，您會發現癌前檢測方面存在最大的變異性，而不是特異性或癌症檢測方面。所以，對我來說，這是一個問號。但最終，我們假設表現就像我們所看到的。然後要記住的是，我們的測試是 PCR 測試，或是我們專有版本的 PCR，這是每次測試方法成本非常低的方法。因此，當我們掌握了拒絕第一線篩檢測試的人的所有數據時。我們有能力與醫療服務提供者、健康系統和付款人合作，讓這些人接受我們的 CRC 血液檢測篩檢，然後嘗試鼓勵他們在接下來的一年中改用 Cologuard。因此，我們認為這對我們來說是一個有意義的機會，而且我們顯然是實現這一目標的最佳人選。尤其是當你看看今天的 Medicare 時，會發現 Medicare B 部分僅占我們整體機會的 20% 以下，而 Medicare Advantage 可能為 22%。佔所有醫療保險患者的一半以上。透過成本較低的測試，我們有能力與那些 Medicare 優勢計劃簽訂合同，並製定明確的計劃，將這些患者轉為獲得 3 年質量衡量信用的測試，這正是他們所關心的。因此，我們對這個機會感到很興奮，我們認為它可以讓更多的人接受篩檢，並推動 Exact 的成長。

The next question comes from Andrew Brackmann with William Blair.

下一個問題來自安德魯·布拉克曼和威廉·布萊爾。

Jeff, thanks, and enjoy the time away, best of luck. Aaron, welcome. You guys talked a couple of times about your progress with health systems. But can you maybe sort of talk about your line of sight to additional partnerships with these groups and just sort of the nature of discussions now versus maybe a couple of years ago?

傑夫，謝謝，祝你旅途愉快，祝你好運。亞倫，歡迎。你們多次談到了衛生系統的進展。但您能否談談您對與這些團體建立更多夥伴關係的看法，以及現在與幾年前相比的討論的性質？

Yes. Thanks, Andrew. Yes, in addition to backlog of colonoscopy health systems, they want to make sure that they can partner with companies that are go beyond product that they have other things that can help them with workflow, can help them with the staff turnover, and that's where we fit really, really nicely. The workflow piece of it -- we're electronically interfaced with our products, which is great. In terms of adding additional things to them, we have an amazing customer service organization that not just -- we're not just providing product, but we're helping them get their patients screened. And that back-end support is tremendous.

是的。謝謝，安德魯。是的，除了大腸鏡檢查衛生系統的積壓之外，他們還希望確保能夠與那些超越產品的公司合作，他們還有其他東西可以幫助他們完成工作流程，可以幫助他們解決員工流動率，這就是我們真的非常非常適合。其中的工作流程部分——我們與我們的產品進行電子交互，這非常棒。在為他們添加額外的東西方面，我們擁有一個令人驚嘆的客戶服務組織，我們不僅提供產品，而且還幫助他們對患者進行篩檢。後端支援是巨大的。

The other thing I'll mention about health systems are the data and analytics that we provide. So a lot of health systems are actually -- they're blinded to a lot of data that they need to get at. So we actually go in with accurate list that need to be screened first time or rescreen where we have a 45 to 49 population that they need to actually detect. When we provide that data and analytics to them, again we're helping them broader than just the product. And that's where we're seeing these partnerships increase quarter-over-quarter.

關於衛生系統，我要提到的另一件事是我們提供的數據和分析。因此，許多衛生系統實際上對他們需要獲得的大量數據視而不見。因此，我們實際上會提供需要首次篩檢或重新篩檢的準確列表，其中我們有 45 到 49 名需要實際檢測的人群。當我們向他們提供數據和分析時，我們再次為他們提供更廣泛的幫助，而不僅僅是產品。這就是我們看到這些合作關係逐季度增加的地方。

Your next question comes from Puneet Souda with Leerink Partners.

您的下一個問題來自 Leerink Partners 的 Puneet Souda。

Kevin, a bigger question for you. It appears that the relationship of Cologuard test to Cologuard reps and the leverage is similar to what you had a few years ago? I mean, simply put more reps means more Cologuard orders. I mean as this is the first time you had slowed down investments in a decade on the reps. So the question is, if the lesson in here is that you will need to continue to scale the sales force as you penetrate the market further for Cologuard in the next few years? Is it safe to say that scaling has to continue and the investments into the business have to continue? Or is there an improved leverage that you'll continue to get as we get into our penetration numbers for Cologuard?

凱文，給你一個更大的問題。看起來 Cologuard 測試與 Cologuard 代表和槓桿的關係與您幾年前的關係類似？我的意思是，只要有更多的代表就意味著更多的 Cologuard 訂單。我的意思是，這是你們十年來第一次放慢對代表的投資。所以問題是，這裡的教訓是否是，隨著您在未來幾年進一步滲透 Cologuard 市場，您是否需要繼續擴大銷售團隊？可以肯定地說，必須繼續擴大規模，並且必須繼續對業務進行投資嗎？或者，當我們了解 Cologuard 的滲透率數據時，您是否會繼續獲得改進的槓桿？

I think the answer to that is "and". We will increase investments and we will get more leverage. So as we become a $2 billion, $2.5 billion, $3 billion, $4 billion category. We will continue to make additional investment. And it's the right thing to do. It's the right thing to do for patients. It's the right thing to do for our customers. They actually want us to come in and help educate their physicians, the nurses, their physician assistants. So we'll have the ability to do this. We're talking about a pretty modest investment in terms of sales force growth relative to the impact. It takes 3 to 6 months to get a return on the investment that you've made. Because the number of Cologuard orders per office visit is high. We haven't, I think, weighed out what that number is, but it's 50% higher now than it was 2 years ago. So it continues to grow and it just makes sense. You would be disappointed in us -- investors would be disappointed in us that we didn't make continued investments in our sales force.

我認為答案是“和”。我們將增加投資，我們將獲得更多槓桿。因此，當我們成為 20 億美元、25 億美元、30 億美元、40 億美元的類別。我們將繼續追加投資。這是正確的做法。這對患者來說是正確的事。對於我們的客戶來說，這是正確的做法。他們實際上希望我們進來幫助教育他們的醫生、護士和醫生助理。所以我們將有能力做到這一點。相對於影響而言，我們談論的是銷售隊伍成長方面相當適度的投資。您的投資需要 3 到 6 個月才能獲得回報。因為每次造訪辦公室的 Cologuard 訂單數量都很高。我認為，我們還沒有衡量過這個數字是多少，但現在比 2 年前高出了 50%。所以它繼續增長，這是有道理的。你會對我們感到失望——投資者會對我們感到失望，因為我們沒有對我們的銷售團隊進行持續的投資。

And I'll just -- this is Everett. I'll just add one other thing to that is as we unlock new opportunities in the field, and I think about our relationships with health systems, our relationship with payers in terms of care gap opportunities. We're doubling down in terms of our federally qualified health centers in challenged geographies and ZIP codes. I talked about the new providers that we generated in the last year. As we unlock these new segments of growth, we're going to need sales reps, account executives multicultural approaches to driving this business. And so it's not just adding reps for the sake of adding reps, but adding reps to get at these new opportunities of growth.

我只是——這是埃弗雷特。我還要補充另一件事，那就是當我們在該領域釋放新的機會時，我會考慮我們與衛生系統的關係，以及我們與付款人在護理差距機會方面的關係。我們正在加倍努力，在困難地區和郵遞區號地區建立符合聯邦資格的醫療中心。我談到了我們去年產生的新提供者。當我們釋放這些新的成長領域時，我們將需要銷售代表、客戶經理採用多元文化的方法來推動這項業務。因此，這不僅是為了增加代表而增加代表，而是為了獲得這些新的成長機會而增加代表。

Our next question comes from Matt Sykes with Goldman Sachs.

我們的下一個問題來自高盛的馬特·賽克斯。

Apologies upfront, I'm going to ask another marketing leverage question, but mine's focused on sort of the shift in mix towards larger health systems. And whether that creates more leverage, either from a centralized call point? Or the fact that some of the health systems once adopted kind of do some of the marketing for you within the system? I'm just wondering if that will allow you that operating leverage you're talking about in terms of increasing marketing spend leading to ever increasing revenue. Just how did the health systems play into that dynamic?

預先道歉，我要問另一個行銷槓桿問題，但我的重點是轉向更大的衛生系統的組合。這是否會透過集中呼叫點創造更多槓桿作用？或者事實上，有些衛生系統曾經採用過，會在系統內為您進行一些行銷？我只是想知道這是否能讓您獲得您所說的營運槓桿，即增加行銷支出，從而導致收入不斷增加。衛生系統到底是如何發揮這種作用的呢？

That, and there is no doubt that you're seeing that leverage. Just going back over the last couple of years, and Jeff can provide the details in terms of the dollar of Cologuard growth, I believe, around [$80 million to $100 million] over the last couple of years, with the sales force that is smaller than it was 2 years ago and a marketing spend that was smaller than it was. The leverage is obvious. The question is how much do you eke that up? And we're eking it up less than the 2022 spend. So the leverage we're getting out of health systems, the leverage we're getting out of payers, the payer leverage is incredible because that is a very small team that is executing on those relationships. And then our IT team and a small group of people around customer experience are really delivering that impact. So this is -- the payer segment is a huge opportunity as we look out over the next 5 to 10 years.

毫無疑問，你正在看到這種槓桿作用。回顧一下過去幾年，Jeff 可以提供有關 Cologuard 增長金額的詳細信息，我相信過去幾年的增長約為 [8000 萬至 1 億美元]，但銷售隊伍規模較小與兩年前相比，營銷支出也比以前少。槓桿作用顯而易見。問題是你能維持多少？我們的支出低於 2022 年的支出。因此，我們從衛生系統中獲得的影響力，我們從付款人那裡獲得的影響力，付款人的影響力是令人難以置信的，因為這是一個非常小的團隊，正在執行這些關係。然後我們的 IT 團隊和一小群圍繞客戶體驗的人員真正發揮了這種影響力。所以，當我們展望未來 5 到 10 年時，付款人細分市場是一個巨大的機會。

And the leverage gets even better over time. Today, here, we are talking mainly about Cologuard. But as we add new products, as we launch new products with this sales team through this electronic ordering channels to the same customer care team, the leverage gets even better. So we're still building some of the foundation here and getting leverage. And over time, I think things get a lot more attractive.

隨著時間的推移，槓桿作用會變得更好。今天，我們主要討論的是 Cologuard。但是，當我們新增產品時，當我們與該銷售團隊透過電子訂購管道向同一個客戶服務團隊推出新產品時，槓桿作用會變得更好。因此，我們仍在建立一些基礎並獲得影響力。隨著時間的推移，我認為事情會變得更有吸引力。

Your next question comes from Dan Brennan with TD Cowen.

您的下一個問題來自 TD Cowen 的 Dan Brennan。

Great. Jeff, obviously good luck. Great working with you. Kevin, so I thought I heard you mention earlier to Doug's question, maybe something about the quarter off to a good start. Maybe there was some comment. I just wanted to clarify that. You've talked about these payer programs in the back half of the year, it sounds like it could be notable. Could you just help frame how we think about those, like size and anything of that? And then to Jeff, you talked about these out-of-period captures that you had last year. Would you be -- could you kind of share with us out of the 1.8 million Cologuard test in the first half last year? I know those grew 34% year-over-year, like any sense or can you help us think through just what percent of those kind of we're at a period so we can kind of normalize things and get a better sense of underlying growth rate? And then any color on 45 to 49, I haven't heard it come up like in terms of kind of contribution or anything in the quarter. We had 105 million in (inaudible) wondering if we were in the right ZIP code.

偉大的。傑夫，顯然祝你好運。和你一起工作真好。凱文，所以我想我聽到你早些時候提到了道格的問題，也許是關於本季良好開局的事情。也許有一些評論。我只是想澄清這一點。您在今年下半年談到了這些付款計劃，聽起來可能很值得注意。您能否幫助我們思考這些問題，例如尺寸之類的？然後你向傑夫談到了去年拍攝的這些過時的照片。您能否與我們分享去年上半年 180 萬次 Cologuard 測驗的情況？我知道這些同比增長了34%，就像任何意義上的那樣，或者您能否幫助我們思考一下我們處於某個時期的此類百分比是多少，以便我們可以使事情正常化並更好地了解潛在的成長速度？然後是 45 到 49 的任何顏色，我還沒有聽說它像貢獻類型或本季的任何事情一樣出現。有 1.05 億人（聽不清楚）想知道我們的郵遞區號是否正確。

We'll keep track of all those questions. I think the first one, what I said was just based on the marketing investment alone, the increased marketing investment in Q1. We have seen accelerated growth in Q2. So we have that confidence with the guide that we've given for Q2. And then when you have the sales force adds and we have even more confidence. So in terms of payer programs in the back half, I don't think we're prepared to size that right now. Last year, it was in the tens of millions of dollars total, and we think it will be significantly more than that in the back half of this year. So we'll probably provide more clarity as time goes on, but that's about as much clarity as Jeff will allow in his last earnings call.

我們將跟踪所有這些問題。我認為第一個，我所說的只是基於行銷投資，第一季增加的行銷投資。我們看到第二季加速成長。因此，我們對第二季的指南充滿信心。當銷售隊伍增加時，我們就會更有信心。因此，就後半部分的付款人計劃而言，我認為我們現在還沒有準備好確定其規模。去年總額為數千萬美元，我們認為今年下半年將大大增加。因此，隨著時間的推移，我們可能會提供更多的清晰度，但這大約是傑夫在上次財報電話會議中允許的清晰度。

A couple more here. You asked on 45 to 49. Still very strong growth here. When you look at the size of opportunities, about 20 million people, about 4 million people turn 45 every year and essentially all of them are on screens. So Cologuard fits in really well. It's a huge opportunity. And it's approaching 20% of revenue of screening revenue today. So very strong growth. It did -- volumes grew double digits in Q1, even with that tough comp. We expect strong growth there to continue. Kevin talked a bit about upping some of the investment target of the [single] population. There's still a long ways for this to run. U.S. on the sequential of last year, what was the impact? We have given some clues here. We haven't sized it, but I'll kind of reiterate that in a normal year, you would expect Q4 to step down and then the Q1. Last year, we saw the opposite. We saw Q1 up. I think it was up almost close to 10%. A few things happened. One was the abnormal flu season last year, very light, very earlier this year, more of a normal flu season. The other were the IT upgrades -- upgraded the building systems and the patient compliance system. So that whole delta is not out-of-period revenue. Some of that is the (inaudible)

這裡還有幾個。你問的是 45 到 49。當你觀察機會的規模時，你會發現每年大約有 2000 萬人、大約 400 萬人年滿 45 歲，基本上所有這些人都出現在螢幕上。所以 Cologuard 非常適合。這是一個巨大的機會。如今，它已接近放映收入的 20%。所以成長非常強勁。確實如此——即使在競爭激烈的情況下，第一季的銷量仍實現了兩位數成長。我們預計該地區將繼續強勁成長。凱文談到了提高[單身]人口的一些投資目標。這還有很長的路要走。美國去年環比有何影響？我們在這裡給了一些線索。我們還沒有確定其規模，但我會重申，在正常年份，您會預期第四季會下降，然後是第一季。去年，我們看到了相反的情況。我們看到第一季上漲。我認為漲幅幾乎接近 10%。發生了一些事情。一個是去年的異常流感季節，很輕，今年很早，更像是正常的流感季節。另一個是 IT 升級——升級建築系統和患者合規系統。因此，整個增量並不是期外所得。其中一些是（聽不清楚）

Your next question comes from David Westenberg with Piper Sandler.

您的下一個問題來自 David Westenberg 和 Piper Sandler。

Congrats Jeff and have a good next chapter in your life. So I just wanted to -- investors were a little bit concerned, I think, with some of the implications for the back half of the year ramp. I actually think you did lay out the comps in the front half of the year were pretty challenging. And I know we're kind of blabbering the question, this kind of [duck] question and Dan's as well. But can you give us any sense of trends in terms of hospital utilization in March? And how much maybe that flows through, give us a reminder of how long it takes to kind of flow through the P&L? And see some of that impact maybe in April and May.

恭喜傑夫，祝你人生新篇章美好。所以我只是想——我認為投資者有點擔心對今年下半年成長的一些影響。事實上，我認為你在今年上半年制定的比較確實非常具有挑戰性。我知道我們有點喋喋不休地提出這個問題，這種[迴避]問題，丹的問題也是。但您能為我們介紹一下 3 月醫院使用率的趨勢嗎？可能會流過多少資金，提醒我們需要多久才能流過損益表？也許會在四月和五月看到一些影響。

And I know you're not in the habit of giving kind of a month-by-month play, but I just really think that maybe a little bit of color on why that's -- again, that second half of the year step up is not that ridiculous? And then just as a clarification, I mean, I think of our models and prior to this earnings -- sorry, prior to this [print] versus right now, I mean, we really aren't going to change very much, right? You're not really asking us to change almost anything on the initial guidance, right? So anyway, that's just it.

我知道你沒有按月進行遊戲的習慣，但我真的認為這可能對為什麼會這樣有一點色彩——再說一次，下半年的進步是不是那麼可笑嗎？然後，作為澄清，我的意思是，我想到了我們的模型和在此收益之前- 抱歉，在此[打印]之前與現在相比，我的意思是，我們真的不會改變太多，對嗎？您並沒有真正要求我們更改初始指導中的幾乎所有內容，對吧？無論如何，僅此而已。

Yes, this is Jeff. I'll start. Agree with you, but we maintained guidance. Look, we're only 90 days in, a long year. We feel very good about our ability to achieve this year and the longer-term goals. I think we did articulate the comps very challenging in the front half. They get easier as the year goes on. We talked about the investment already starting to see the impact in April of the marketing investments. The sales rep investments, very confident there that will play off kind of mid-year and beyond. Again, we've done this before. We know the reps carry a very strong return, and we're looking forward to seeing that. And then the care gap program, Kevin gave some clues on sizing, that inherently is more second half weighted, seeing very good early demand and confident in the growth in the second half there. You asked on the flow-through of kind of macro factors into our P&L.

是的，這是傑夫。我開始吧。同意你的觀點，但我們保留了指導。看，我們只有 90 天了，漫長的一年。我們對今年實現和長期目標的能力感到非常滿意。我認為我們在前半場確實闡明了非常具有挑戰性的比賽。隨著時間的推移，他們會變得更容易。我們談到的投資已經開始看到四月行銷投資的影響。銷售代表的投資非常有信心，這將在年中及以後發揮作用。再說一次，我們以前已經這樣做過。我們知道代表會帶來非常豐厚的回報，我們期待看到這一點。然後是護理缺口計劃，凱文給了一些關於規模的線索，本質上更多的是下半年的加權，看到非常好的早期需求，並對下半年的成長充滿信心。您詢問了一些宏觀因素對我們損益表的影響。

The typical timing from, let's say, from a order, which physicians typically would order Cologuard or Oncotype during a face-to-face visit. Cologuard is a (inaudible) visit. So I think of 30 to 40 days or so still from a [wellness listed] to the median time we get to revenue, there can be a longer tail. It can be up to, say, 12 months, and most of that happens fairly early. When you think -- you asked on kind of overall hospital utilization, that's not something we typically monitor broadly. We look more at things like wellness visits and screening trends. Wellness visit has been softer. This is a multiyear trend we've seen, they have been softer while there is still 60 million people out there who need to be screened today, and we expect very strong growth to continue. What listed that have been down year-on-year recently, I think it's even close to 10% in recent quarters. That's something that we can fight through given the opportunity that presents here.

比方說，從訂單開始的典型時間安排，醫生通常會在面對面就診期間訂購 Cologuard 或 Oncotype。 Cologuard 是一次（聽不清楚）訪問。因此，我認為從[列出的健康]到我們獲得收入的中位數時間還需要 30 到 40 天左右，可能會有更長的尾巴。比如說，可能長達 12 個月，而且大部分發生得相當早。當您思考—您詢問醫院的整體使用率時，這不是我們通常廣泛監控的內容。我們更關注健康訪問和篩檢趨勢等事情。健康訪問變得更加溫和。這是我們看到的一個多年趨勢，雖然目前仍有 6000 萬人需要接受篩檢，但情況已經趨於疲軟，我們預計強勁的成長將持續下去。最近上市的同比下降了，我認為最近幾季甚至接近10%。鑑於這裡提供的機會，這是我們可以克服的問題。

We might be able to take one more question and it comes from Mark Massaro with BTIG.

我們或許可以再問一個問題，它來自 BTIG 的 Mark Massaro。

Jeff, you'll be missed, and Aaron, welcome to Exact. So I'll ask two questions. One is for you, Kevin. You talked about USPSTF perhaps now in 2027. I think many of us were thinking 2026, although we also recognize there's been a little bit of a delay with their bulletin. Can you just expand on why you think it will go into '27? And then maybe for you, Jeff or Kevin, Certainly, I think one of the surprises on the call was your increased expansion of salespeople. Kevin, you indicated that overall spending will still be down in '24 relative to '23. Is that just on the sales and marketing line? Or is that total OpEx? And in order to keep your revenue guidance intact, Help us think about what some of the puts and takes might be? In other words, should we expect a little bit of less investment in R&D?

傑夫，我們會想念你的，亞倫，歡迎來到 Exact。所以我會問兩個問題。一份是給你的，凱文。您談到的 USPSTF 可能是在 2027 年。您能否詳細說明為什麼您認為它將進入 27 年？然後也許對你來說，傑夫或凱文，當然，我認為電話會議中的驚喜之一是你擴大了銷售人員。 Kevin，您表示 24 年的整體支出相對於 23 年仍會下降。這只是在銷售和行銷線上嗎？或者說這是總營運支出？為了保持您的收入指導不變，請幫助我們考慮可能的一些看跌期權和賣出期權是什麼？換句話說，我們是否應該預期研發投入會減少一些？

So what I said was that sales and marketing expense in '24 would still be less than it was in '22. So it will obviously be up from '23 and somewhere in that range. And obviously, we have -- we have a lot of room in our overall budget to be able to achieve all of our goals, both top line and bottom line with the resources we have. And again, I'd like to emphasize that this is a modest increase in terms of our overall sales spend. and marketing spend. But we would just for clarity sake, we wanted to deliver that. And also I will reiterate our confidence in the guide.

所以我說的是，24 年的銷售和行銷費用仍然會低於 22 年。因此，它顯然會高於 23 年以及該範圍內的某個位置。顯然，我們的整體預算中有很大的空間，能夠利用我們擁有的資源來實現我們的所有目標，包括頂線和底線。我想再次強調，就我們的整體銷售支出而言，這是適度的成長。和行銷支出。但為了清楚起見，我們想要實現這一點。我還將重申我們對指南的信心。

So we know our business, we know it really well. I'll repeat what I said earlier with I've never been more confident about the near- and long-term trajectory of Exact. And we're excited about Cologuard and also the new product launches that we have that are coming as well. In terms of the USPSTF timing, Typically, what you would have seen already is in the first quarter document that emanates from USPSTF laying out what the study plan is and what the whole schedule is. And we just heard that, that may be pushed out a year. If it's not a surprise, USPSTF is a really busy group with a fixed amount of resources. And if you remember, Cologuard when it first got included in the guidelines in 2014, the prior update was 8 years before that. So although the stated schedule is 5 years, it was 8 years and then 5 years.

所以我們了解我們的業務，我們非常了解。我將重複我之前所說的話，我對 Exact 的近期和長期發展軌跡從未如此有信心。我們對 Cologuard 以及我們即將推出的新產品感到興奮。就 USPSTF 的時間表而言，通常您已經看到的是 USPSTF 發布的第一季文件，其中列出了研究計劃以及整個時間表。我們剛剛聽說，​​這可能會推遲一年。如果不出意外的話，USPSTF 是一個非常繁忙的組織，擁有固定數量的資源。如果你還記得，Cologuard 在 2014 年首次被納入指南時，先前的更新是在 8 年前。所以雖然規定的時間表是5年，但實際上是8年，然後是5年。

Yes. So it's not unusual for there to be a little bit of a delay, and it's critical. There's yes, aspiring entrants can come to market, but we know how hard it was to deliver on Cologuard in those early years when we weren't in the quality measures. It was -- it was tough to get customers to order Cologuard as a replacement for the FIT test, which was in the quality measures. So -- we're in a strong position. And here's another thing that people don't fully appreciate. We're already working on Cologuard 3. And so in terms of improved performance even from Cologuard Plus, we're never going to stop investing in being the unquestioned leader in colon cancer screening. We've work really hard to deliver on the impact that we've had in this disease. We're proud of it. And our R&D team is second to none. And our commercial organization, we've been talking about the new heads -- the impact Everett's organization has had, it has been remarkable and the leverage that they've been able to deliver. They're really proud of what they've done and you're just going to see continued positive results.

是的。因此，出現一點延遲並不罕見，而且很重要。是的，有抱負的進入者可以進入市場，但我們知道，在早年，當我們沒有進行品質衡量時，交付 Cologuard 是多麼困難。很難讓客戶訂購 Cologuard 作為 FIT 測試的替代品，而 FIT 測試屬於品質衡量標準。所以——我們處於有利地位。還有一件人們沒有完全理解的事情。我們已經在研究 Cologuard 3。我們非常努力地發揮我們對這種疾病的影響。我們為此感到自豪。我們的研發團隊是首屈一指的。我們的商業組織，我們一直在談論新的領導者——埃弗里特的組織所產生的影響是非凡的，以及他們所能提供的影響力。他們對自己所做的事情感到非常自豪，並且您將會看到持續的正面成果。

I'm going to go to Eve Burstein with Bernstein Research.

我要去伯恩斯坦研究中心拜訪伊芙‧伯斯坦。

I'll actually ask a question not about Cologuard, but about Oncotype DX Breast and how the FDA LDT rule affects it? This one is an interesting case because you're the clear market leader here, but some of your competitors in the space do have FDA approval. So a couple of parts here. One, our understanding is that your LDT test would be grandfathered in. You only need to pursue FDA approval if you decided to change the test, which seems pretty unlikely. Is that right? Two, if you did choose to pursue FDA approval, have you already generated the data that you need to do so in the rich body of literature you already have? Or would you need to do more work? And then three, if you didn't choose to pursue FDA approval, could you be at a new competitive disadvantage versus the FDA-approved tests that are out there?

實際上，我要問的問題不是關於 Cologuard，而是關於 Oncotype DX Breast 以及 FDA LDT 規則如何影響它？這是一個有趣的案例，因為您是這裡明顯的市場領導者，但您在該領域的一些競爭對手確實獲得了 FDA 的批准。這裡有幾個部分。一，我們的理解是，您的 LDT 測試將被繼承。是對的嗎？第二，如果您確實選擇尋求 FDA 批准，您是否已經在已有的豐富文獻中產生了所需的數據？或者你需要做更多的工作嗎？第三，如果您不選擇尋求 FDA 批准，與 FDA 批准的現有測試相比，您是否會處於新的競爭劣勢？

You are correct. There is a grandfathering provision in the new guidance document. So Oncotype DX is in a great position in the U.S. and outside the U.S. based on our current regulatory position. That won't change. And we're also in New York state approved. So there are two different ways that we are okay with the current approach. We also have the ability to submit for FDA approval should anything change in the future, which we don't expect to do. But we have more data with Oncotype DX than virtually any diagnostic ever developed. I think altogether, 4 or 5 New England Journal of Medicine publications, randomized studies and well over 1 million, probably well over 1.5 million total patient results. So it may be one of the most studied diagnostics, cancer diagnostics of all time. We're in great shape.

你是對的。新的指導文件中有一項祖父條款。因此，根據我們目前的監管狀況，Oncotype DX 在美國和美國以外的地區都處於有利地位。那不會改變。我們也獲得了紐約州的批准。因此，我們有兩種不同的方式可以接受目前的方法。如果將來發生任何變化，我們也有能力提交 FDA 批准，但我們不希望這樣做。但我們使用 Oncotype DX 獲得的數據幾乎比迄今為止開發的任何診斷方法都要多。我認為總共有 4 到 5 份《新英格蘭醫學雜誌》出版物、隨機研究以及超過 100 萬、可能超過 150 萬的患者總結果。因此，它可能是有史以來研究最多的診斷方法之一，即癌症診斷方法。我們的狀態很好。

And we're in great shape from a competitive perspective. And that's important because Oncotype DX is the only test that has that Level 1 that Tier 1 evidence because of the multiple randomized controlled studies and other tests just have not been able to prove what we've been able to prove both in terms of the ability to predict chemotherapy benefit and also determine the likelihood of recurrence. Those are two benefits that nobody else has been able to show with the level of evidence that we've been able to show. So we're confident in continued growth.

從競爭的角度來看，我們處於良好的狀態。這很重要，因為 Oncotype DX 是唯一具有 1 級、1 級證據的測試，因為多項隨機對照研究和其他測試無法證明我們在能力方面已經能夠證明的內容預測化療效果並確定復發的可能性。這兩個好處是其他人無法以我們能夠展示的證據水平證明的。因此，我們對持續成長充滿信心。

All right. Thank you, ladies and gentlemen. That concludes today's call. I appreciate you all for joining. You may now disconnect.

好的。謝謝你們，女士們、先生們。今天的電話會議到此結束。我感謝大家的加入。您現在可以斷開連線。