Exact Sciences Corp (EXAS) 2023 Q1 法說會逐字稿

Thank you for standing by. My name is Jordan, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Exact Sciences Corporation Q1 2023 Conference Call. (Operator Instructions)

謝謝你的支持。我叫 Jordan，今天我將擔任你們的會議運營商。此時，我想歡迎大家參加 Exact Sciences Corporation 2023 年第一季度電話會議。 （操作員說明）

With me now is Vice President, Investor of Relations, Megan Jones. You may begin your conference.

現在和我在一起的是副總裁兼關係投資人梅根·瓊斯 (Megan Jones)。你可以開始你的會議。

Thanks, Jordan. Thank you for joining us for Exact Sciences' First 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, will also be available for questions.

謝謝，喬丹。感謝您加入我們參加 Exact Sciences 2023 年第一季度電話會議。今天參加電話會議的有公司董事長兼首席執行官凱文·康羅伊 (Kevin Conroy)；和我們的首席財務官 Jeff Elliott。我們的首席商務官 Everett Cunningham 也將回答問題。

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

Exact Sciences 今天下午早些時候發布了一份新聞稿，詳細介紹了我們第一季度的財務業績。本新聞稿和今天的演示文稿可在我們的網站 exactsciences.com 上獲取。

During today's call, we will make forward-looking statements based on current expectations. Our actual results may 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. Both can be accessed through our website.

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

I'll now turn the call over to Kevin.

我現在將電話轉給凱文。

Thanks, Megan. I'm incredibly proud of our team, their dedication to our mission and the record quarter they delivered. During the first quarter, core revenue grew $148 million year-over-year or 33%. We're raising our full year guidance for revenue by $110 million and adjusted EBITDA by $100 million. We now expect to turn free cash flow positive during this year, ahead of our previous target of next year.

謝謝，梅根。我為我們的團隊、他們對我們使命的奉獻以及他們交付的創紀錄季度感到無比自豪。第一季度，核心收入同比增長 1.48 億美元，增幅為 33%。我們將全年收入指引提高了 1.1 億美元，並將調整後的 EBITDA 提高了 1 億美元。我們現在預計今年將實現自由現金流為正，超過我們之前設定的明年目標。

In the fourth quarter of 2014, the first quarter we launched Cologuard, we tested 4,000 people. In the first full year after launch, we tested 100,000 people. It took 3.5 years to screen our first 1 million people with Cologuard. This year, we've already screened more than 1.2 million people.

2014 年第四季度，也就是我們推出 Cologuard 的第一季度，我們測試了 4,000 人。在發布後的第一年，我們測試了 100,000 人。用 Cologuard 篩查我們的前 100 萬人用了 3.5 年。今年，我們已經對超過 120 萬人進行了篩查。

Cologuard has transformed the way that we screen for the number 2 deadliest cancer in the U.S. And we still have a huge opportunity to make an impact with 60 million people who are not up to date with screening. The platform we've built will continue to change the way cancer is detected and treated. We're just starting to realize its full potential. Our first quarter results demonstrate the power of focusing on what is best for patients and our customers. At Exact Sciences, this means we develop tests based on a deep understanding of the biology of the disease and science, generate the highest level of clinical evidence supporting the test use and build the operations necessary to deliver an amazing customer experience.

Cologuard 改變了我們篩查美國第二大最致命癌症的方式。我們仍然有巨大的機會對 6000 萬未及時進行篩查的人產生影響。我們構建的平台將繼續改變檢測和治療癌症的方式。我們才剛剛開始意識到它的全部潛力。我們第一季度的業績證明了專注於對患者和我們的客戶最有利的事情的力量。在 Exact Sciences，這意味著我們基於對疾病生物學和科學的深刻理解開發測試，生成最高水平的臨床證據來支持測試的使用，並建立必要的操作來提供令人驚嘆的客戶體驗。

Combining these with an investment in strong brands enables durable revenue growth, industry-leading gross margins and growing profits. A portion of those profits will support investments in the next wave of life-changing diagnostic advancements, creating an unstoppable innovation engine.

將這些與對強大品牌的投資相結合，可以實現持久的收入增長、行業領先的毛利率和不斷增長的利潤。這些利潤的一部分將支持對下一波改變生活的診斷進步的投資，創造一個不可阻擋的創新引擎。

Other highlights from the first quarter include delivering more than 1 million total tests, including a record number of Cologuard results, generating $46 million in adjusted EBITDA, an improvement of $136 million year-over-year, launching OncoExTra, our enhanced therapy selection test, and making progress toward completing BLUE-C, our pivotal study to support our next-generation Cologuard and colon cancer blood tests.

第一季度的其他亮點包括提供超過 100 萬次總測試，包括創紀錄數量的 Cologuard 結果，產生 4600 萬美元的調整後 EBITDA，同比增長 1.36 億美元，推出增強型治療選擇測試 OncoExTra，並在完成 BLUE-C 方面取得進展，這是我們支持下一代 Cologuard 和結腸癌血液檢測的關鍵研究。

Jeff will now review our first quarter results.

傑夫現在將審查我們的第一季度業績。

Thanks, Kevin. First quarter revenue of $602 million grew 24%. Core revenue of $598 million grew 33%, excluding COVID testing, the sale of our prostate business and foreign exchange. Screening revenue of $443 million increased 45%. The majority of screening revenue upside came from broad-based momentum in Cologuard adoption with additional benefits from a relatively mild flu season and enhancements made last year to our patient compliance program and billing systems.

謝謝，凱文。第一季度收入為 6.02 億美元，增長 24%。 5.98 億美元的核心收入增長了 33%，不包括 COVID 測試、前列腺業務的出售和外匯。 4.43 億美元的放映收入增長了 45%。篩查收入的大部分增長來自 Cologuard 採用的廣泛勢頭，以及相對溫和的流感季節和去年對我們的患者合規計劃和計費系統進行的改進帶來的額外好處。

During the quarter, 10,000 new health care professionals ordered Cologuard, bringing the total to over 312,000. Precision Oncology revenue increased 2% to $155 million. Growth was 8%, excluding the sale of our prostate business and a $1 million FX headwind. COVID testing revenue decreased 86% to $4 million. First quarter GAAP gross margin was 71%. Non-GAAP gross margin, excluding the amortization of acquired intangibles, was 74%. Gross margin benefited from fixed cost leverage in our lab and improvements made to the Cologuard patient compliance program and billing systems.

本季度，有 10,000 名新醫療保健專業人員訂購了 Cologuard，使總數超過 312,000 人。 Precision Oncology 收入增長 2% 至 1.55 億美元。增長率為 8%，不包括出售我們的前列腺業務和 100 萬美元的外匯逆風。 COVID 測試收入下降 86% 至 400 萬美元。第一季度 GAAP 毛利率為 71%。不包括收購的無形資產的攤銷，非 GAAP 毛利率為 74%。毛利率受益於我們實驗室的固定成本槓桿以及 Cologuard 患者合規計劃和計費系統的改進。

GAAP net loss was $74 million. Adjusted EBITDA was $46 million, an improvement of $136 million, driven by better-than-expected revenue and gross margin. We ended the quarter with cash and securities of about $700 million.

GAAP 淨虧損為 7400 萬美元。調整後的 EBITDA 為 4600 萬美元，增加了 1.36 億美元，這得益於好於預期的收入和毛利率。我們在本季度結束時擁有約 7 億美元的現金和證券。

Turning to guidance. We expect total revenue between $589 million and $604 million during the second quarter and $2.38 billion and $2.42 billion for the year. This assumes screening revenue between $443 million and $453 million for the second quarter and $1.77 billion and $1.795 billion for the year. Precision Oncology revenue between $145 million and $150 million for the second quarter and $605 million and $620 million for the year, and COVID revenue of $5 million for the year. We plan to discontinue COVID testing after the second quarter. For the year, this implies 19% core revenue growth, with 25% growth in Screening and 5% growth in Precision Oncology, excluding the sale of our prostate business and foreign exchange.

轉向指導。我們預計第二季度總收入在 5.89 億美元至 6.04 億美元之間，全年總收入為 23.8 億美元至 24.2 億美元。假設第二季度放映收入在 4.43 億美元至 4.53 億美元之間，全年放映收入在 17.7 億美元至 17.95 億美元之間。 Precision Oncology 第二季度收入在 1.45 億美元至 1.5 億美元之間，全年收入為 6.05 億美元至 6.2 億美元，COVID 收入為 500 萬美元。我們計劃在第二季度後停止 COVID 測試。今年，這意味著核心收入增長 19%，篩查增長 25%，精準腫瘤學增長 5%，不包括前列腺業務的銷售和外匯。

We are increasing our adjusted EBITDA guidance by $100 million and now expect between $100 million and $125 million for the year. We now expect to earn free cash flow positive during the year, 12 months ahead of our original target and then generate full year positive free cash flow next year. I'll now turn the call back to Kevin.

我們將調整後的 EBITDA 指引增加了 1 億美元，現在預計今年將達到 1 億至 1.25 億美元。我們現在預計在年內獲得正自由現金流，比我們最初的目標提前 12 個月，然後在明年產生全年正自由現金流。我現在將電話轉回凱文。

Thanks, Jeff. There are 60 million Americans unscreened for colon cancer and Cologuard is the only solution to get them screened accurately, easily and in the privacy of their own home. Screening rates have been persistently low for decades. This problem has been intensified by the addition of nearly 20 million people to the screening population when the recommended start age was moved from age 50 to age 45. Capacity for screening colonoscopies in the U.S. is relatively fixed and health systems are motivated to increase screening rates. We estimate it would take 10 years for gastroenterologists to screen everyone who is due today with colonoscopy alone.

謝謝，傑夫。有 6000 萬美國人未接受結腸癌篩查，而 Cologuard 是讓他們在家中進行準確、輕鬆和私密篩查的唯一解決方案。幾十年來篩查率一直很低。當建議的起始年齡從 50 歲提高到 45 歲時，篩查人群增加了近 2000 萬人，這個問題變得更加嚴重。美國結腸鏡檢查的篩查能力相對固定，衛生系統有動力提高篩查率.我們估計，胃腸病學家僅通過結腸鏡檢查就可以對今天到期的每個人進行篩查需要 10 年的時間。

Health systems, which represent more than half the market are recognizing the opportunity to partner with us to address their screening rates and related quality measures. They rely on Cologuard as an essential part of their screening toolkit and are embedding it in their workflows. We have implemented more than 275 electronic ordering interfaces, connecting health systems to Exact Sciences. Our data showed that Cologuard market share is about 50% higher in the largest 400 health systems versus independent practices in smaller systems. Cologuard will continue to screen more Americans and help eradicate this preventable disease.

佔市場一半以上的衛生系統正在認識到與我們合作的機會，以解決他們的篩查率和相關質量措施。他們依靠 Cologuard 作為他們篩選工具包的重要組成部分，並將其嵌入到他們的工作流程中。我們已經實施了超過 275 個電子訂購界面，將衛生系統連接到 Exact Sciences。我們的數據顯示，Cologuard 在最大的 400 個衛生系統中的市場份額比小型系統中的獨立實踐高出約 50%。 Cologuard 將繼續篩查更多的美國人，並幫助根除這種可預防的疾病。

Our Precision Oncology portfolio guides treatment decisions for more than 200,000 cancer patients every year. Our Oncotype DX test helps early-stage breast cancer patients determine whether they will benefit from chemotherapy and our OncoExTra test helps late-stage cancer patients determine their best treatment options. A consistent focus on high-quality tests, top-tier clinical evidence and physician education has cemented Oncotype DX as standard of care. Our international team of 200 people is working to ensure women everywhere have access to this life-changing information. The Oncotype DX test generates durable high-margin revenue and cash flow. This supports adoption of new tests such as OncoExTra and molecular residual disease tests.

我們的精準腫瘤學產品組合每年為超過 200,000 名癌症患者指導治療決策。我們的 Oncotype DX 測試幫助早期乳腺癌患者確定他們是否會從化療中獲益，我們的 OncoExTra 測試幫助晚期癌症患者確定他們的最佳治療方案。對高質量測試、頂級臨床證據和醫師教育的持續關注鞏固了 Oncotype DX 作為護理標準的地位。我們由 200 人組成的國際團隊正在努力確保世界各地的女性都能獲得這種改變生活的信息。 Oncotype DX 測試產生持久的高利潤收入和現金流。這支持採用新的測試，例如 OncoExTra 和分子殘留疾病測試。

We're making progress in our 3 most impactful pipeline programs, colon cancer screening, multi-cancer early detection and molecular residual disease. In colon cancer screening, we are on track to share top line data this summer from our BLUE-C trial for our next-generation Cologuard test. We recently ran next-generation Cologuard on approximately 7,700 blinded DeeP-C samples, and the results give us confidence in our goal to improve specificity and precancer sensitivity. As a reminder, DeeP-C was our pivotal study supporting Cologuard's FDA approval in 2014.

我們在 3 個最具影響力的管線項目中取得了進展，即結腸癌篩查、多癌症早期檢測和分子殘留疾病。在結腸癌篩查方面，我們有望在今年夏天分享我們下一代 Cologuard 測試的 BLUE-C 試驗的頂級數據。我們最近對大約 7,700 個盲法 DeeP-C 樣本運行了下一代 Cologuard，結果使我們對提高特異性和癌前敏感性的目標充滿信心。提醒一下，DeeP-C 是我們在 2014 年支持 Cologuard 獲得 FDA 批准的關鍵研究。

The second prospective study will provide valuable evidence supporting next-generation Cologuard's clinical value and competitively unique position. In multi-cancer early detection, we plan to share 2 additional sets of case-control data this year, further validating our comprehensive multimarker class approach. In molecular residual disease, or MRD, we share data detailing our tumor-informed and tumor-agnostic approaches at the American Association of Cancer Research Conference last month. We plan to enhance our algorithm and generate additional evidence before making our tumor-informed approach available in colon cancer.

第二項前瞻性研究將提供有價值的證據支持下一代 Cologuard 的臨床價值和獨特的競爭地位。在多癌症早期檢測方面，我們計劃今年再分享 2 組病例對照數據，進一步驗證我們全面的多標記類方法。在分子殘留病或 MRD 方面，我們在上個月的美國癌症研究協會會議上分享了詳細說明我們的腫瘤知情和腫瘤不可知方法的數據。我們計劃在將我們的腫瘤知情方法用於結腸癌之前增強我們的算法並生成更多證據。

We will continue developing tests based on a deep understanding of the disease and science, generating the highest level of clinical evidence supporting their use, and leveraging the operations we've built to deliver the best customer experience. This innovation engine built on the broadest, most capable platform in cancer diagnostics will support continued revenue growth, industry-leading gross margins and growing profits. This will allow us to solve the biggest problems in cancer care and deliver returns to our shareholders.

我們將繼續基於對疾病和科學的深刻理解開發測試，生成最高水平的臨床證據來支持它們的使用，並利用我們已經建立的運營來提供最佳的客戶體驗。這種建立在最廣泛、最強大的癌症診斷平台上的創新引擎將支持持續的收入增長、行業領先的毛利率和不斷增長的利潤。這將使我們能夠解決癌症治療中最大的問題，並為我們的股東帶來回報。

We're now happy to take your questions.

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 from Jefferies.

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

Kevin, what would you say would be the 1 or 2 things that you think were most impactful in the first quarter in terms of driving the revenue outperformance. And Jeff, if we look at the guidance for the balance of the year, it seems to imply screening revenue is flat over the next 3 quarters for the balance of the year. Is that informed by March or April orders or just being conservative in where we are at this point of the year?

凱文，你會說什麼是你認為在第一季度推動收入超越表現方面影響最大的一兩件事。傑夫，如果我們看一下今年餘下時間的指導，這似乎意味著在接下來的 3 個季度中，今年餘下時間的放映收入將持平。這是根據 3 月或 4 月的訂單提供的信息，還是只是對今年這個時候我們所處的位置保守？

Why don't I take it and hand it over then to Everett, who will hand it over to Jeff. So there are just many drivers that have seen the strength in Cologuard testing. It's investments that we've made over the last 9 years, and it's also just tremendous execution over the past few quarters. So it's really wonderful, you hand it to the entire team to make this work. These are investments in our commercial team, an incredible sales team and marketing capabilities, our labs, operations, the brand building we've done, the R&D team who have brought innovations into our lab, into the product, our digital compliance team, analytics. It's just so exciting to see so many strengths across the entire company, Cologuard, Oncotype and the PreventionGenetics business. Everett?

為什麼我不把它交給 Everett，然後由他交給 Jeff。所以只有很多司機看到了 Cologuard 測試的優勢。這是我們在過去 9 年中進行的投資，也是過去幾個季度的巨大執行力。所以這真的很棒，你把它交給整個團隊來完成這項工作。這些是對我們的商業團隊的投資，一個令人難以置信的銷售團隊和營銷能力，我們的實驗室，運營，我們已經完成的品牌建設，將創新帶入我們實驗室的研發團隊，產品，我們的數字合規團隊，分析.看到整個公司、Cologuard、Oncotype 和 PreventionGenetics 業務擁有如此多的優勢真是太令人興奮了。埃弗里特？

Yes, I'll add some color to that. As Kevin said, we've made many investments over the years. I've been out in the field over the last few quarters, and one thing I'm seeing is I'm seeing that momentum of the investments pick up. And our -- the confidence in our sales organization, the messaging that they have around the products, is just so clear with the customers. The other thing I'll mention is regard with the customers. The customers are now realizing, especially in the screening space, that we can partner with them. They're trying to hit screening and other metrics out there around quality, and they know that they can't do it alone. So how they partner with Exact Sciences and our organization to hit those metrics, we're seeing that pick up over the last few quarters.

是的，我會為此添加一些顏色。正如凱文所說，這些年來我們進行了許多投資。在過去的幾個季度裡，我一直在這個領域，我看到的一件事是我看到投資勢頭正在回升。而我們 - 對我們的銷售組織的信心，他們對產品的信息，對客戶來說非常清楚。我要提到的另一件事是對客戶的尊重。客戶現在意識到，尤其是在放映領域，我們可以與他們合作。他們正試圖通過篩选和其他有關質量的指標，而且他們知道他們無法獨自完成。因此，他們如何與 Exact Sciences 和我們的組織合作以達到這些指標，我們在過去幾個季度看到了這種情況。

And the last thing I'll mention is around just our targeting around our top customers. Our health systems, as Kevin said in his statements, they drive a lot of our volume. And the focus that we have with calling on the right health systems with the right message and ensuring that we're being, again, a partner and ensuring they can screen the right people to me, I see that picking up over the last few quarters. I'll pass it to Jeff.

我要提到的最後一件事就是圍繞我們的頂級客戶定位。正如凱文在他的聲明中所說，我們的衛生系統推動了我們的大量業務。我們的重點是用正確的信息呼籲正確的衛生系統，並確保我們再次成為合作夥伴，並確保他們能夠向我篩選合適的人，我看到在過去幾個季度裡這種情況有所增加.我會把它傳給傑夫。

Thanks, Everett. So Brandon, on your question on the phasing in guidance, I would just take a step back and look at the -- what we've built here over 9 years, we built out Cologuard to over $1.7 billion of revenue. And again, here we are 9 years into launch, growing over 25% for the year. So we feel really good about the quarter we delivered. We're raising the top line guidance by well north of the Q1 beat. So that speaks to the optimism for the rest of the year.

謝謝，埃弗里特。所以布蘭登，關於你關於分階段指導的問題，我只想退後一步，看看我們在這裡建立了超過 9 年的東西，我們建立了 Cologuard 超過 17 億美元的收入。再一次，我們推出 9 年了，今年增長超過 25%。因此，我們對交付的季度感覺非常好。我們將第一季度節拍以北的最高線指導提高了。因此，這說明了今年餘下時間的樂觀情緒。

On the phasing, two things to keep in mind. One is really around first quarter. First quarter be it our own internal expectations, a very strong quarter. The majority of that was underlying momentum that Kevin and Everett just talked about. We also got some benefit from a mild flu season, impossible to quantify that, but it did help as we talked about in our last earnings call. And there was a couple of smaller things that contributed. We also previously talked about the carryover benefit from enhancements to our patient compliance engine and our billing systems. Those went in place in last year. We got a little bit of benefit in Q1 from that.

關於分階段，有兩件事要記住。一個真的是在第一季度左右。第一季度是我們自己的內部預期，一個非常強勁的季度。其中大部分是凱文和埃弗里特剛剛談到的潛在動力。我們也從溫和的流感季節中獲得了一些好處，無法量化，但正如我們在上次財報電話會議上談到的那樣，它確實有所幫助。還有一些較小的事情做出了貢獻。我們之前還談到了增強患者合規引擎和計費系統帶來的結轉收益。那些在去年就位了。我們在第一季度從中獲得了一些好處。

When I think of the rest of the year now, there's a typical summer seasonality. During the summer, fewer people go out for physicals so that, therefore, there's incrementally less growth between Q1 and -- or Q2 and throughout the year because that's summer seasonality. This year, there's a one new dynamic to lay on top of that. That's related to the impact from COVID 3 years ago hurt the Cologuard business, primarily in second quarter and third quarter of 2020. Now flash forward to 2023, when rescreens are about 20% of Cologuard revenue, the contribution from rescreens is somewhat muted this year because of that COVID impact from 3 years ago. The brunt of that takes place in the second and third quarters.

當我現在想到今年剩下的時間時，就會有典型的夏季季節性。在夏季，更少的人出去參加體育鍛煉，因此，第一季度和第二季度之間以及全年的增長逐漸減少，因為那是夏季的季節性。今年，除此之外還有一種新的動力。這與 3 年前 COVID 對 Cologuard 業務的影響有關，主要是在 2020 年第二季度和第三季度。現在快進到 2023 年，屆時重新加網約佔 Cologuard 收入的 20%，今年重新加網的貢獻有所減弱因為 3 年前的 COVID 影響。首當其衝的是第二節和第三節。

So from a phasing standpoint, you expect -- you would expect a flatter year this year. However, when you jump ahead to next year now, 3-year rescreens reaccelerates because next year now, you go from having 1.2 million people eligible this year, newly eligible Cologuard rescreen patients, which is the same as last year. Next year, you jump up to 1.6 million more people. So that rescreen contribution should accelerate again next year.

因此，從階段性的角度來看，你預計 - 你會預計今年會比較平淡。然而，當你現在跳到明年時，3 年的重新篩選會重新加速，因為明年現在，你從今年有 120 萬人符合條件，新符合條件的 Cologuard 重新篩選患者，這與去年相同。明年，你會增加 160 萬人。因此，明年重新篩選的貢獻應該會再次加速。

Yes. And Jeff, if you're not too nervous about me referring to numbers here. And Q2 of 2020, there were about 275,000 Cologuard tests. And in Q2 of 2021, there were about 575,000 Cologuard tests. So that bounce back is going to occur. This is just a onetime artifact that will have some impact. But the team is awfully excited about the year. And if I could encapsulate the biggest change that has occurred is health systems are coming to us asking for help. And that has strategic implications for everything we're doing at Exact Sciences, addressing the entire cancer continuum. That's exciting with every product in our pipeline that we're working on and it fires up the R&D team and the commercial team and the lab teams. And -- so we can't wait.

是的。傑夫，如果你對我在這裡提到的數字不太緊張的話。而在 2020 年第二季度，大約進行了 275,000 次 Cologuard 測試。而在 2021 年第二季度，大約有 575,000 次 Cologuard 測試。所以反彈將會發生。這只是一個會產生一些影響的一次性工件。但團隊對這一年感到非常興奮。如果我能概括已經發生的最大變化，那就是衛生系統正在向我們尋求幫助。這對我們在 Exact Sciences 所做的一切都具有戰略意義，解決整個癌症連續體。我們正在開發的每一款產品都令人興奮，它激發了研發團隊、商業團隊和實驗室團隊的熱情。而且 - 所以我們等不及了。

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

我們的下一個問題來自花旗的 Patrick Donnelly。

Jason on for Patrick. Maybe just one on the adjusted EBITDA guide moving up $100 million. Just wondering if you can talk about that strength in the quarter, the embedded assumptions for the rest of the year. I think GAAP OpEx declined slightly in the quarter and just the gross margin.

傑森換帕特里克。也許只是調整後的 EBITDA 指南中的一個增加了 1 億美元。只是想知道您是否可以談談本季度的實力，以及今年剩餘時間的內在假設。我認為 GAAP OpEx 在本季度略有下降，只是毛利率下降。

Yes. So we're pleased with what the team could deliver in the first quarter, $46 million, which exceeded the original guidance for the year. I'd point back to what Kevin talked about. We've been at Exact Sciences building for 9 years now, this foundation, a foundation that allows for robust top line growth, margin expansion, cash flow generation. This foundation is scalable, it's robust, and you're seeing it now. You're seeing it in the numbers, and you should continue to see it in the years to come. So we're pleased with how that unfolded in the first quarter.

是的。因此，我們對團隊在第一季度交付的 4600 萬美元的成果感到滿意，這超過了當年的最初指導。我會指出凱文所說的內容。我們已經在 Exact Sciences 建立了 9 年，這個基礎，一個允許強勁的收入增長、利潤擴張和現金流產生的基礎。這個基礎是可擴展的，它是強大的，你現在就看到了。你在數字中看到了它，你應該在未來幾年繼續看到它。因此，我們對第一季度的表現感到滿意。

That allowed us to raise the EBITDA guidance by $100 million, just 1 quarter in. So when you think about the -- I would highlight the incrementals. The incremental adjusted EBITDA margin this year is about 80% now. So you're seeing the efficiency of this platform. What we've assumed is we talked to the top line numbers. No change to the assumptions baked in for gross margin around 73%. And for OpEx, no change there still on a GAAP basis in the mid-single-digit range. So again, you're seeing the power of this platform really unfold, we can deliver top line growth, gross margin expansion, OpEx leverage and now free cash flow for the first time.

這使我們能夠將 EBITDA 指導提高 1 億美元，僅 1 個季度。所以當你考慮 - 我會強調增量。今年增量調整後的 EBITDA 利潤率現在約為 80%。所以你看到了這個平台的效率。我們假設的是我們與頂線數字進行了交談。毛利率約為 73% 的假設沒有變化。而對於 OpEx，在 GAAP 基礎上仍然沒有變化，處於中個位數範圍內。所以，你再次看到這個平台的力量真正展現出來，我們可以實現收入增長、毛利率擴張、OpEx 槓桿和現在的自由現金流。

Your next question comes from the line of Catherine Schulte.

你的下一個問題來自 Catherine Schulte。

I guess could you just talk to the cadence of Cologuard orders throughout the quarter? And any commentary on you saw in April and May so far?

我想你能談談整個季度 Cologuard 訂單的節奏嗎？到目前為止，您在 4 月和 5 月看到的任何評論？

Sure, Catherine. This is Jeff. Happy to take that one. We typically don't get into intra-quarter commentary, but you can hear from our comments that the majority of the upside was driven by broad-based momentum which speaks to -- there is no kind of big one-timer at the end of the quarter, something this is broad-based throughout the quarter. The commercial team did just a fabulous job by staying disciplined, week on week on week, driving the growth continue to advance the marketing campaign. So this was just a really strong quarter top to bottom. There's not like one big thing that came in. And obviously, when you look at the guide here, we beat by, call it, $50 million, $60 million. We're raising guidance by $100 million. So that speaks to the optimism that we're seeing in the numbers and for the rest of the year.

當然，凱瑟琳。這是傑夫。很高興接受那個。我們通常不會進入季度內評論，但你可以從我們的評論中聽到，大部分上行是由廣泛的勢頭推動的——這表明——在季末沒有那種一次性的大動作這個季度，這在整個季度都有廣泛的基礎。商業團隊通過保持紀律，一周又一周地完成了出色的工作，推動增長繼續推進營銷活動。所以這只是一個非常強勁的季度自上而下。沒有一件大事進來。很明顯，當你看這裡的指南時，我們擊敗了，稱之為 5000 萬美元，6000 萬美元。我們將指引提高了 1 億美元。因此，這說明了我們在數字和今年剩餘時間裡看到的樂觀情緒。

Your next question comes from the line of Vijay Kumar.

你的下一個問題來自 Vijay Kumar。

I had a two parter, Kevin. The first one for you on your comment on health systems. Is that what we're seeing generally looking at Q4 and Q1 uptick in Cologuard numbers. Any sense on what percentage of revenues or perhaps physicians are employed by health systems? And are we at the early stage here? Or can you talk about penetration of health systems where we are? And then my second one, Jeff, for you on this EBITDA guide. The $100 million to $125 million, it looks like you guys have achieved half of it in Q1. Why wouldn't the Q1 sustain into the back half given the revenue guide raise?

我有兩個夥伴，凱文。第一個關於您對衛生系統的評論。這就是我們普遍看到的 Cologuard 數字在第四季度和第一季度的上升趨勢。對衛生系統僱用的收入或醫生的百分比有何看法？我們還處於早期階段嗎？或者你能談談我們所在的衛生系統的滲透嗎？然後是我的第二個，Jeff，關於這個 EBITDA 指南。 1 億美元到 1.25 億美元，看起來你們在第一季度已經實現了一半。鑑於收入指南提高，為什麼第一季度不能持續到後半段？

Let me start. I'll take the first part of that question. So health systems have seen a dramatic increase in the electronic ordering rate. The dynamic is typically about halfway through the year, the health systems get hyper focused on their quality, colon cancer screening quality measure. And they are increasingly reaching out to us to ask us to help in a holistic way address the challenge that exists when you add 20 million people to the screening population and you have a fixed colonoscopy infrastructure. Today, if you focus on the 400 largest health systems of almost 2/3 of them have implemented electronic ordering and resulting. That keeps getting better over time, the ease of use, the reporting, the data they get, and then how we use that together fuels a deeper relationship with those health systems. Everett, do you want to add to that?

讓我開始吧。我將回答這個問題的第一部分。因此，衛生系統的電子訂購率急劇上升。這種動態通常是在一年中的一半左右，衛生系統高度關注他們的質量，結腸癌篩查質量措施。他們越來越多地聯繫我們，要求我們以整體方式幫助解決當您將 2000 萬人加入篩查人群並且您擁有固定的結腸鏡檢查基礎設施時存在的挑戰。今天，如果你關注 400 個最大的衛生系統，其中近 2/3 已經實施了電子訂購和結果。隨著時間的推移，這種情況會變得越來越好，易用性、報告、他們獲得的數據，以及我們如何一起使用這些，都有助於與這些衛生系統建立更深層次的關係。 Everett，你想補充一下嗎？

Yes. When I think of health systems and our execution over the past couple of years, I think about the investments that we've made. We've increased our strategic account management towards our top health systems. We have a very disciplined way that we review our plans for health systems all the way from Kevin all the way down to the people that are calling on health systems. And the other thing I would mention with health systems, it's a local strategy. We have not only calling on the C-suite of the health system, but the way in which we're deployed the pull-through of the representatives with affiliated physicians of those health systems, that team is all one team, and we've seen better execution because everybody is embedded together in making sure that we can execute that health system strategy that's leading to more growth.

是的。當我想到過去幾年的衛生系統和我們的執行時，我會想到我們所做的投資。我們增加了對頂級衛生系統的戰略客戶管理。我們有一種非常有紀律的方式來審查我們的衛生系統計劃，從凱文一直到呼籲衛生系統的人。關於衛生系統，我要提到的另一件事是地方戰略。我們不僅呼籲衛生系統的最高管理層，而且我們部署代表與這些衛生系統的附屬醫生的方式，該團隊都是一個團隊，我們已經看到更好的執行，因為每個人都嵌入在一起，以確保我們能夠執行導致更多增長的衛生系統戰略。

Vijay, it's Jeff. I'll take the rest of it. From a percent of revenue standpoint for Cologuard, I think of is in the 60% range for health systems, and that number is up nicely from where it was, say, 3 to 5 years ago. So the team has done a nice job there. Overall penetration rate for Cologuard is in the 10% range. And based on what Kevin talked about for health systems, it's probably a bit higher. But the key takeaway here is there's a long ways to go here with 60 million people unscreened, we've got years and years of strong growth for Cologuard ahead of us.

維杰，是傑夫。剩下的我來拿。從 Cologuard 收入的百分比來看，我認為醫療系統的收入在 60% 的範圍內，這個數字比 3 到 5 年前的水平有了很好的增長。所以團隊在那裡做得很好。 Cologuard 的整體滲透率在 10% 左右。根據凱文談到的衛生系統，它可能會更高一些。但這裡的關鍵要點是，有 6000 萬人沒有接受篩查，還有很長的路要走，我們前面有 Cologuard 多年的強勁增長。

Your question on the adjusted EBITDA number, thanks for noticing $46 million, really strong results in the first quarter. That came in better than we expected. That's in part due to the higher level of revenue and gross margin in the first quarter than we expected. It's also in part due to the way that our operating expense assumptions phase through the year. Our plans call for us to hire throughout the year. And so that's part of why you're not going to have -- you can't take the first quarter and multiply it times 4 and get to the adjusted EBITDA number for the year.

你關於調整後的 EBITDA 數字的問題，感謝你注意到第一季度的 4600 萬美元，非常強勁的結果。這比我們預期的要好。這在一定程度上是由於第一季度的收入和毛利率水平高於我們的預期。這在一定程度上也是由於我們的運營費用假設在一年中分階段進行的方式。我們的計劃要求我們全年招聘。所以這就是為什麼你不會擁有的部分原因 - 你不能將第一季度乘以 4 並獲得當年調整後的 EBITDA 數字。

Also, we've chosen to reinvest some of the incremental margin that we're generating to accelerate programs. One I'd highlight here is MRD. That market is unfolding and our R&D efforts have reached a point where the team said, "Hey, now is the right time to up the investment here to accelerate our path to market." So that's part of why the phasing for adjusted EBITDA, you can't just take Q1 and assume that level holds.

此外，我們選擇將我們為加速項目而產生的部分增量利潤進行再投資。我要在這裡強調的一個是 MRD。那個市場正在展開，我們的研發工作已經到了團隊說，“嘿，現在是增加投資以加速我們進入市場的正確時機。”所以這就是調整後 EBITDA 分階段的部分原因，你不能只採用 Q1 並假設該水平保持不變。

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

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

Kevin, I appreciate the commentary around Cologuard 2.0 running to -- running that against samples from DeeP-C, maybe just sort of give us a bit more color around what you saw in those results compared to previous data that we saw? And then I guess as we just get closer to the top line readout here this summer, can you just sort of level set us on how you're thinking about any degradation from those previous studies to this pivotal?

凱文，我很欣賞圍繞 Cologuard 2.0 運行的評論——針對 Deep-C 的樣本運行它，與我們之前看到的數據相比，也許只是讓我們對你在這些結果中看到的內容有更多的了解？然後我想當我們今年夏天接近頂線讀數時，你能不能讓我們了解一下你是如何考慮從以前的研究到這個關鍵的任何退化？

Thanks, Andrew. The -- we will release that data. And all I will say is the data gives us confidence going into the BLUE-C study. As you remember, the main goal is to improve the specificity. Specificity is calculated in 2 different ways. One is if you take a look at kind of all comers, that in Cologuard -- the current version of Cologuard is 87%. Our goal is to improve that to 89%. If you only look at people with what we would call clean colons, no small polyps, non-adenoma polyps, which still send off some signal. If you exclude those, then we would expect the specificity to be 90% or greater. So that's -- we also remain -- we continue to expect cancer sensitivity to be equal to or better than Cologuard and the precancer sensitivity to be -- we hope to see an improvement there. That would be a great result.

謝謝，安德魯。 - 我們將發布該數據。我要說的是數據讓我們有信心進入 BLUE-C 研究。正如您所記得的，主要目標是提高特異性。特異性以兩種不同的方式計算。一個是如果你看一下所有人，在 Cologuard 中—— Cologuard 的當前版本是 87%。我們的目標是將其提高到 89%。如果你只看那些我們稱之為乾淨結腸的人，沒有小息肉，非腺瘤息肉，它們仍然會發出一些信號。如果您排除這些，那麼我們預計特異性為 90% 或更高。所以這就是——我們也仍然——我們繼續期望癌症敏感性等於或優於 Cologuard 和癌前敏感性——我們希望在那裡看到改善。那將是一個很好的結果。

And Andrew, I just want to drive home the point. We ran the study against all of the available samples that we had from DeeP-C. That study was from 10 years ago, so we didn't have access to all of the samples. But we ran them against all of the samples that we had available and didn't select out any for any particular reason. And that was blinded. And that gives us a second prospective study, which, as you know, when you're looking at guidelines and evidence development is very, very important.

安德魯，我只是想強調這一點。我們針對我們從 Deep-C 獲得的所有可用樣本進行了研究。那項研究是 10 年前的，所以我們無法訪問所有樣本。但是我們針對所有可用的樣本運行它們，並且出於任何特定原因沒有選擇任何樣本。那是盲目的。這為我們提供了第二項前瞻性研究，如您所知，當您查看指南和證據開發時，這非常非常重要。

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

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

I was hoping you could talk a little bit about the regional dynamics for Oncotype DX that you're seeing at the moment? Just looking at the 10-Q, it looks like the international growth in the quarter was really strong. I was just wondering if that was offset, how the U.S. performed as well? Just any commentary as to what's going on, would be great.

我希望你能談談你目前看到的 Oncotype DX 的區域動態？只看 10-Q，該季度的國際增長似乎非常強勁。我只是想知道這是否被抵消了，美國的表現如何？任何關於正在發生的事情的評論都會很棒。

And Jack, thanks for the question. This is Jeff. When you look at the growth in the U.S., given our strong market share there, I think the way to think about growth is somewhere just north of incidents. So incidents in the U.S. is probably around 3.5% growth per year. So somewhere in that kind of low to mid-single-digit range for the Oncotype franchise is the right way to think about it. Internationally is a different story. Internationally, the overall penetration rate there is probably in the 25% range. So we expect strong double-digit growth for years to come internationally. The next big driver of growth would be launched in the Japan market, which we expect midyear. So that should open up the second largest market outside the U.S.

傑克，謝謝你的提問。這是傑夫。當你看美國的增長時，鑑於我們在那裡的強大市場份額，我認為考慮增長的方式就在事件的北部。因此，美國的事件可能每年增長 3.5% 左右。因此，在 Oncotype 特許經營權的那種低到中等個位數範圍內的某個地方是正確的思考方式。在國際上則是另一回事。在國際上，那裡的整體滲透率大概在25%左右。因此，我們預計未來幾年國際市場將實現兩位數的強勁增長。下一個增長的主要驅動力將在日本市場推出，我們預計將在年中推出。所以這應該打開美國以外的第二大市場

So that one can be a little choppier given the dynamics of new markets coming online, but there's still a long runway ahead. Longer term, perhaps the most exciting opportunity for the broader Precision Oncology growth comes to some of the pipeline tests that Kevin talked about MRD. That market is, as you know, much larger even than the Oncotype market. So that's a big driver that we're looking forward to. And also don't forget that within the broader PO umbrella, we have our broader advanced therapy selection platform that is growing nicely.

因此，考慮到新市場上線的動態，這可能會有點不穩定，但前面還有很長的路要走。從長遠來看，也許更廣泛的 Precision Oncology 增長最令人興奮的機會來自凱文談到 MRD 的一些管道測試。如您所知，該市場甚至比 Oncotype 市場大得多。所以這是我們期待的一個重要驅動力。也不要忘記，在更廣泛的 PO 保護傘下，我們擁有更廣泛的高級治療選擇平台，該平台發展良好。

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

您的下一個問題來自 Stifel 的 Dan Arias。

Kevin, I wanted to look out a little bit and ask about this Braidwood case that looks like it's working its way towards the Supreme Court here and is relevant for the USPSTF recommended tests. It sounds like it has the potential to jam up the works for Cologuard, but it also sounds like some of these industry groups are coming out and expressing confidence in just continued coverage. I mean, obviously, nothing is finalized there. But what are you hearing? How are you handicapping the risk to the out years? Even if you don't think it's meaningful to coverage, do you think it could be a factor on pricing at all? I'd love to just get your thought there.

凱文，我想稍微注意一下，並詢問一下這個布雷德伍德案，該案看起來正在向最高法院提起訴訟，並且與 USPSTF 推薦的測試相關。聽起來它有可能阻礙 Cologuard 的工作，但聽起來這些行業組織中的一些正在站出來表達對繼續報導的信心。我的意思是，很明顯，那裡沒有什麼是最終確定的。但是你在聽什麼？你如何阻止未來幾年的風險？即使您認為它對覆蓋範圍沒有意義，您認為它是否會成為定價的一個因素？我很樂意讓你的想法在那裡。

No, I don't think that, that Supreme Court decision is going to have a negative impact on Cologuard. And the main reason for that is the preventive services and HEDIS measures and the incentive structure around preventive services remains intact regardless of what the Supreme Court might do there. And since Cologuard is embedded into those quality measures, there is still a very, very strong bias in the health systems to screen people with tests that are recommended tests. So that doesn't change anything. Health payers aren't going to change their view about whether to cover Cologuard because of the Supreme Court case.

不，我不認為最高法院的裁決會對 Cologuard 產生負面影響。主要原因是預防性服務和 HEDIS 措施以及圍繞預防性服務的激勵結構保持不變，無論最高法院可能在那裡做什麼。由於 Cologuard 被嵌入到這些質量措施中，因此衛生系統中仍然存在非常、非常強烈的偏見，即使用推薦的測試來篩選人們。所以這不會改變任何東西。健康支付者不會因為最高法院的案件而改變他們對是否承保 Cologuard 的看法。

They love the benefit of Cologuard in terms of this less expensive than colonoscopy. They save money in any given budget year and that's a real positive. So I don't think that, that's going to impact us. I sure hope the Supreme Court leaves that law in place. I think it's very positive for other tests that may come down through the arduous process that Cologuard went through. And -- but it's certainly not going to have an impact on Cologuard. We're -- policymakers in DC through are evaluating avenues to move the plaintiff's arguments in that case. And I think are looking at ways to even reform the oversight in appointment of USPSTF members. There's a lot in the works, but the whole health care ecosystem relies on USPSTF is a critical part of guideline recommendations. I don't think that's going to go away.

他們喜歡 Cologuard 的好處，因為它比結腸鏡檢查便宜。他們在任何給定的預算年度都可以節省資金，這是一個真正的積極因素。所以我認為這不會影響我們。我當然希望最高法院保留該法律。我認為這對於 Cologuard 經歷的艱鉅過程中可能下來的其他測試來說是非常積極的。而且——但它肯定不會對 Cologuard 產生影響。我們 - DC 的政策制定者正在評估在該案中推動原告論點的途徑。我認為正在尋找方法來改革對 USPSTF 成員任命的監督。有很多工作要做，但整個醫療保健生態系統依賴於 USPSTF 是指南建議的關鍵部分。我認為這不會消失。

Your next question comes from the line of Derik De Bruin from Bank of America.

你的下一個問題來自美國銀行的 Derik De Bruin。

This is [Wolf] on for Derik. Congrats on a really solid quarter. I was wondering if you could offer some color on the 45 to 49 group. Where is penetration at compared to the 8% that you posted last quarter? And can you talk to what kind of contribution you saw this quarter and how you expect that group to play out for the balance of the year?

這是 Derik 的 [Wolf]。祝賀一個非常穩固的季度。我想知道您是否可以為 45 到 49 組提供一些顏色。與上一季度公佈的 8% 相比，滲透率在哪裡？您能否談談您在本季度看到了什麼樣的貢獻，以及您希望該團隊在今年餘下的時間裡發揮怎樣的作用？

Yes. So what I love about the 45 to 49 is it gives us a really good entree into the office to talk about this cohort, we are in line with delivering on our full 45 to 49 rescreen priorities. And the reason why we're executing wells because it's been a consistent focus area of ours over the last couple of years. We've done a good job of not proliferating growth strategies but making sure that we stick to the 45 to 49. And just to mention rescreen this year will be 20% of our revenue. So these are big growth opportunities for us. It's consistent messaging that we have with our physicians, making them aware of the new screening age, and we're going to continue to do that for the full year.

是的。所以我喜歡 45 到 49 是它讓我們進入辦公室討論這個群體的一個很好的入口，我們符合我們的全部 45 到 49 重新篩選優先事項。以及我們執行井的原因是因為它在過去幾年中一直是我們的重點領域。我們在不擴散增長戰略方面做得很好，但確保我們堅持 45 到 49。而且今年的重新篩選將占我們收入的 20%。所以這些對我們來說是巨大的增長機會。這是我們與醫生之間的一致信息，讓他們了解新的篩查年齡，我們將在全年繼續這樣做。

This is Jeff. Just to add to what Everett said, penetration has really been a highlight for this younger age group. And no surprise, Cologuard really fits into that younger person's lifestyle very well. Overall penetration rate there now is 10%. So it's in line with Cologuard for all ages. So it just shows you the demand all of those younger age group has, and we see that continuing. In fact, if you look out just 3 years, the combination of rescreens and 45, we expect to contribute around $1 billion of revenue. So this is a huge driver for us today, and it will be for years to come.

這是傑夫。補充一下 Everett 所說的，滲透率確實是這個年輕群體的一大亮點。毫不奇怪，Cologuard 非常適合年輕人的生活方式。現在那裡的整體滲透率是10%。所以它符合所有年齡段的Cologuard。所以它只是向你展示了所有這些年輕群體的需求，而且我們看到這種需求還在繼續。事實上，如果你只看 3 年，重新篩选和 45 次的組合，我們預計將貢獻約 10 億美元的收入。所以這對我們今天來說是一個巨大的推動力，未來幾年也會如此。

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

你的下一個問題來自高盛的 Matt Sykes。

Congrats on the quarter. Everett, maybe one for you, just going back to the health systems. Can you maybe talk about sort of how that market is shifting in terms of sort of the largest system versus independent practices? And just how much scale and infrastructure it takes to actually gain a new health system. I would assume there's many different decision points and an enterprise-led sales very different than sort of what you're doing with independent practices. Can you maybe talk about how you've kind of gone after the newer health system clients that you've brought on board? And how much scale and infrastructure that actually takes to do?

祝賀這個季度。埃弗雷特，也許是給你的，回到衛生系統。您能否談談該市場在最大系統與獨立實踐方面的變化情況？以及真正獲得新的衛生系統需要多少規模和基礎設施。我假設有許多不同的決策點和企業主導的銷售與您通過獨立實踐所做的事情有很大不同。你能談談你是如何追求你帶來的新衛生系統客戶的嗎？實際需要多少規模和基礎設施？

Thanks for that question. What we've seen, especially after the pandemic is we see kind of a consolidation of health systems, health systems buying other health systems. And we feel that we are well staffed, if you will, and deployed to make an impact at health systems. As I said earlier, we have a strategic account management team in all of our businesses, Screening, Precision Oncology and PreventionGenetics. We've invested in this team, not just in the number of strategic account managers but in the way in which we train them, the marketing materials that they get that allow them not just to call on physicians, but it allows them to call on the C-suite of those organizations because that's where a lot of decisions are made.

謝謝你的問題。我們所看到的，尤其是在大流行之後，我們看到了某種程度的衛生系統整合，衛生系統購買其他衛生系統。我們認為，如果您願意的話，我們的人員配備齊全，並且可以對衛生系統產生影響。正如我之前所說，我們在所有業務、篩查、精準腫瘤學和預防遺傳學方面都有一個戰略客戶管理團隊。我們對這個團隊進行了投資，不僅投資於戰略客戶經理的數量，還投資於我們培訓他們的方式，他們獲得的營銷材料使他們不僅可以拜訪醫生，還可以拜訪這些組織的最高管理層，因為這是做出很多決定的地方。

In terms of scale, I love the way that we're structured because the health systems team with the strategic account managers and the representatives are on the same team now. So when something is -- the decision is made at that health system highest level, it is so much easier for us to now pull that through and generate growth. And the last thing, I'll just reiterate that Kevin said, health systems are now coming to us. They know that they can't do this alone. And so the relationships that we have at that health system because of the many years of investments that we've made, the relationships that we have, they're coming to us for how can we help them hit their quality metrics, how can we help them get and hit their screening percentages. And we're seeing that just gain momentum over the last year.

就規模而言，我喜歡我們的結構方式，因為衛生系統團隊與戰略客戶經理和代表現在在同一個團隊中。因此，當某事是——在衛生系統最高級別做出決定時，我們現在更容易實現這一目標並實現增長。最後一件事，我只想重申凱文所說的，衛生系統現在正在向我們走來。他們知道他們不能單獨做到這一點。因此，由於我們多年來的投資，我們在該衛生系統中擁有的關係，我們擁有的關係，他們來找我們，我們如何幫助他們達到他們的質量指標，我們如何才能幫助他們獲得併達到他們的篩選百分比。我們看到這在去年獲得了增長勢頭。

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

您的下一個問題來自 TD Cowen 的 Dan Brennan。

Maybe just on profitability and free cash flow. Do you kind of pull forward the free cash flow to 2023 and obviously, profitability a lot stronger in Q1. Can you just give us a sense of some of the trade-offs here. Top line growth is really strong. But as we look ahead, say, beyond '23, kind of how much of this kind of progression path is sustainable. Obviously, you'll remain positive. I'm just wondering kind of where margins could get to and kind of remind us as we get towards the Investor Day, kind of what kind of outlook we could expect to get in terms of timing?

也許只是盈利能力和自由現金流。您是否將自由現金流提前到 2023 年，顯然，第一季度的盈利能力要強得多。你能給我們介紹一下這裡的一些權衡取捨嗎？收入增長非常強勁。但是，當我們展望未來時，比如說，在 23 年後，這種進步路徑有多少是可持續的。顯然，你會保持積極的態度。我只是想知道利潤率可以達到什麼程度，並在我們接近投資者日時提醒我們，我們可以期望在時間方面獲得什麼樣的前景？

Thanks, Dan. What you're seeing here is a fundamental turning point. What you saw in Q1 was the power of the platform that we've been building for many years. We've been investing and investing. By the way, very much appreciate the support of investors along the way there because we're building something special. And it's a platform that allows us to both grow and generate profitability. So we don't have to make significant trade-offs going forward. We continue to invest right now in a bright future. And if we see opportunities to drive revenue growth by making investments, we'll continue to do that. We're in a position to do that, and we want to do that to achieve our mission. Jeff?

謝謝，丹。你在這裡看到的是一個根本性的轉折點。您在第一季度看到的是我們多年來一直在構建的平台的強大功能。我們一直在投資和投資。順便說一句，非常感謝一路以來投資者的支持，因為我們正在打造一些特別的東西。它是一個讓我們既能發展又能產生盈利的平台。因此，我們不必在未來做出重大權衡。我們現在繼續投資於光明的未來。如果我們看到通過投資推動收入增長的機會，我們將繼續這樣做。我們有能力做到這一點，我們希望這樣做以實現我們的使命。傑夫？

So Dan, when you look at the first quarter, I think this is indicative of what's to come. You saw strong top line growth, strong gross margin improvement and disciplined FX. In fact, when you look at total revenue of 24%, OpEx down 1%, that's speaks to the power of the platform that we've developed over a 9-year period. So going forward, this platform was designed to scale efficiently. We've been front-loading investments for years and things like our lab, our sales and marketing teams, our IT and digital infrastructure, that will allow us to scale. I can't comment on future years right now. But our goal wasn't just to get the free cash flow positivity, our goals to get there pushed through and keep generating incremental growth year-on-year. So that is the plan.

所以丹，當你看第一季度時，我認為這預示著未來會發生什麼。您看到了強勁的收入增長、強勁的毛利率改善和紀律嚴明的外匯。事實上，當您查看 24% 的總收入時，運營支出下降 1%，這說明了我們在 9 年期間開發的平台的力量。因此，展望未來，該平台旨在高效擴展。多年來，我們一直在進行前期投資，比如我們的實驗室、我們的銷售和營銷團隊、我們的 IT 和數字基礎設施，這將使我們能夠擴展。我現在不能對未來幾年發表評論。但我們的目標不僅僅是獲得自由現金流的積極性，我們的目標是推動實現這一目標並保持同比增長。這就是計劃。

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

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

Congrats on a strong quarter here. So first one, and I'll keep it to one actually. I don't know if you had an opportunity to look at this, but any data that you're seeing in terms of the feed or the feedback from the field in terms of the 45- to 49-year-old, are they gravitating more towards the Cologuard versus colonoscopy, sort of help us understand the dynamic there. This is a new population that's entering the market. Maybe just give us a sort of sense of the performance of the test there too for 45- to 49-year-old with respect to methylation. So it would be helpful if you can provide color on those points.

祝賀這裡有一個強勁的季度。所以第一個，實際上我會保留它。我不知道你是否有機會看到這個，但是你看到的關於 45 到 49 歲的反饋或現場反饋的任何數據，他們是否引力更傾向於 Cologuard 與結腸鏡檢查，有點幫助我們了解那裡的動態。這是一個正在進入市場的新人群。也許只是讓我們對 45 至 49 歲人群在甲基化方面的測試表現有所了解。因此，如果您可以在這些點上提供顏色，將會很有幫助。

Puneet, this is Jeff. I can start and others may want to jump in. But when you look at the relative demand here, look, it's strong across the board. Cologuard has been the fastest diagnostics launched in history. The first diagnostic to get over $1 billion and still generating very strong top line growth. So the demand is significant. And look, there's a long ways to go with 60 million people that are unscreened. From a relative standpoint, if you compare 45 to 49 versus 50 and over, we've talked about 45 to 49 achieving the same penetration rate in about 1.5 years, 2 years that it took the 50 over age group to get to in closer to 9 years. So the demand there is robust. If you just think about it, I'm in this age group now. I know that I've got a lot of commitments with family, with kids and outside of work. I don't want to take off 2 days for a colonoscopy. That's why -- that's one of the reasons I choose Cologuard. It fits into my lifestyle better.

普尼特，這是傑夫。我可以開始，其他人可能想加入。但是當你看看這裡的相對需求時，你看，它在各個方面都很強勁。 Cologuard 是歷史上推出的最快的診斷產品。第一個獲得超過 10 億美元並且仍然產生非常強勁的收入增長的診斷。所以需求量很大。看吧，6000 萬未接受篩查的人還有很長的路要走。從相對的角度來看，如果將 45 至 49 歲與 50 歲及以上年齡段進行比較，我們討論過 45 至 49 歲年齡組在大約 1.5 年內實現了相同的普及率，而 50 歲以上年齡組則用了 2 年才接近9年。所以那裡的需求很強勁。如果你仔細想想，我現在就在這個年齡段。我知道我對家庭、孩子和工作之外有很多承諾。我不想為結腸鏡檢查請假 2 天。這就是為什麼 - 這就是我選擇 Cologuard 的原因之一。它更適合我的生活方式。

Actual survey work and real world demand supports that. From a performance standpoint, the label is the label and that was established with Cologuard in DeeP-C that we've referenced today on the call. We have run an additional prospective study in this younger age group. The study wasn't designed to demonstrate cancer sensitivity. So it's not something that we talk about. So the label is the label, and look forward to continued success in this young age group.

實際調查工作和現實世界的需求支持這一點。從性能的角度來看，標籤就是標籤，它是在 DeeP-C 中通過 Cologuard 建立的，我們今天在電話會議上提到了這一點。我們在這個較年輕的年齡組中進行了一項額外的前瞻性研究。該研究並非旨在證明癌症敏感性。所以這不是我們談論的事情。所以標籤就是標籤，期待在這個年輕的年齡段繼續取得成功。

And I'll just add what Jeff said in terms of the 45- to 49-year-old, our messaging in the field is fantastic. They are the Cologuard patient. You talk about the only solution from a screening standpoint as accuracy, effectiveness, then you can do it in the privacy of your home. A lot of 45- to 49-year olds are on the go. This is the perfect product, not just from a selling standpoint, but we're also messaging from a marketing standpoint. Our latest campaign, the [My Way] campaign and our messaging is geared towards this younger patient, this younger population. And then our customer experience lever that we have in terms of surround sound outreach, not just through TV but through digital and social media is very well geared towards that 45- to 49-year-old.

我只想補充 Jeff 所說的 45 到 49 歲的人，我們在現場的信息傳遞非常棒。他們是 Cologuard 患者。從篩選的角度來看，您談論的唯一解決方案是準確性、有效性，然後您可以在家中私密地進行。許多 45 至 49 歲的人都在忙碌。這是一款完美的產品，不僅從銷售的角度來看，而且我們還從營銷的角度傳達信息。我們最新的活動，[My Way] 活動和我們的信息是針對這個年輕的患者，這個年輕的人群。然後，我們在環繞聲推廣方面擁有的客戶體驗槓桿，不僅通過電視，還通過數字和社交媒體，非常適合 45 至 49 歲的人群。

Your next question comes from the line of Kyle Mikson from Canaccord Genuity.

您的下一個問題來自 Canaccord Genuity 的 Kyle Mikson。

Congrats on the great quarter here and the cash flow news as well on EBITDA. So just a question on next-generation Cologuard. With this BLUE-C readout coming up pretty soon here. I'm just curious about precancer sensitivity, just given the importance of that metric as you included in a bunch of the DDW posters this past week, where I think you noted the threshold like 40% like a baseline there. Do you think that the precancer sensitivity in BLUE-C, there's going to be a game over for some of the emerging options. I mean, obviously, it probably means blood, but I mean that's kind of a [blended] and then just one other question of generation Cologuard. What's the path there for HEDIS since it took Cologuard a few years, but that's been a huge tailwind, I think. So would be curious to hear that.

祝賀這裡的偉大季度和現金流新聞以及 EBITDA。所以只是關於下一代 Cologuard 的問題。這個 BLUE-C 讀數很快就會出現在這裡。我只是對癌前敏感性感到好奇，只是考慮到該指標的重要性，正如您在上週的一系列 DDW 海報中所包含的那樣，我認為您在其中註意到了 40% 的閾值，就像那裡的基線一樣。你認為 BLUE-C 中的癌前敏感性，對於一些新興的選擇來說，遊戲會結束嗎？我的意思是，很明顯，它可能意味著血液，但我的意思是這是一種[混合]，然後只是一代 Cologuard 的另一個問題。自從 Cologuard 花了幾年時間，HEDIS 的發展方向是什麼，但我認為這是一個巨大的順風。所以會很好奇聽到這個。

I'm sorry, what's the path forward to HEDIS for what?

抱歉，HEDIS 的發展方向是什麼？

Cologuard's next generation.

Cologuard 的下一代。

Yes. Let me take that one first. I think that Cologuard 2.0 fits within the current definition of USPSTF. So it doesn't really have to go through another cycle. It just is an improvement on the current technology that's already included in those guidelines. Presumably, it will be. We'll wait until the summer to share the data. In terms of the importance of the evidence that Cologuard set, I'll go back to what we have said. From a regulatory standpoint, Cologuard is a PMA-level product. That means it's the highest level of rigor for any medical device or diagnostic because it's cancer. And so the way the regulatory -- the agency FDA looks at this is typically, you need to have at least as good as performance. You can't have degradation in a product, or at best, you would get a secondary screening play, which hampers your ability to commercialize that in a meaningful way.

是的。讓我先拿那個。我認為 Cologuard 2.0 符合 USPSTF 的當前定義。所以它真的不需要經歷另一個週期。它只是對那些指南中已經包含的當前技術的改進。據推測，它會。我們將等到夏天才能共享數據。關於 Cologuard 設置的證據的重要性，我將回到我們所說的內容。從監管的角度來看，Cologuard 是 PMA 級別的產品。這意味著它是任何醫療設備或診斷的最高級別，因為它是癌症。因此，監管機構 FDA 對此的看法通常是，您至少需要與性能一樣好。你不能讓產品退化，或者充其量你會得到二次篩選，這會阻礙你以有意義的方式將其商業化的能力。

Precancer sensitivity is important. You think, well, how important could it be? Well, you can see from our DDW poster or abstract, 80% of the benefit of screening comes from finding and removing precancerous polyps. 80% of the benefit. So if you look at it on a population level, the difference between, let's call it, like 15% precancer detection and 40% precancer detection is you are on a population level that inferior test only is achieved somewhere around 40% of the life years gained of -- or 60%. 60% of the life years gained as a test with 40-plus percent precancer detection. It's critically important. And this is what the guideline group looks at. They looked at very sophisticated models, which answer the question, what's the impact of a new screen mortality.

癌前敏感性很重要。你認為，嗯，它有多重要？那麼，您可以從我們的 DDW 海報或摘要中看到，80% 的篩查益處來自發現和去除癌前息肉。 80%的收益。因此，如果您在人口水平上看它，我們稱之為 15% 癌前病變檢測和 40% 癌前病變檢測之間的區別是您處於人口水平上，只有大約 40% 的生命年實現了劣質檢測增加了——或 60%。通過 40% 以上的癌前病變檢測獲得 60% 的壽命。這非常重要。這就是指南小組關注的內容。他們研究了非常複雜的模型，這些模型回答了這個問題，即新屏幕死亡率的影響是什麼。

I believe that the BLUE-C data has the potential to set a new bar. Now what do we think about our blood program. Because I think there's an embedded second question there. And our blood program is if we end up with a secondary screening claim with the test that's built on proprietary PCR platform, we can deliver at cost, the testing to patients who just refuse other forms of screening. I think that we all know family members, friends who have avoided screening and they've been diagnosed. We at Exact Sciences, happen to know who those patients are in combination with our health system partners, we can deliver a solution to people who refuse other more -- better forms of screening. So we're in a great position with Cologuard as the leading product, adding a blood test, we think, is going to help save lives because we know who the refuser are.

我相信 BLUE-C 數據有可能樹立新的標杆。現在我們如何看待我們的血液計劃。因為我認為那裡有一個嵌入式的第二個問題。我們的血液計劃是，如果我們最終通過建立在專有 PCR 平台上的測試進行二次篩查，我們可以按成本向拒絕其他形式篩查的患者提供檢測。我想我們都認識沒有接受篩查但被確診的家人和朋友。在 Exact Sciences，我們碰巧知道這些患者是誰，與我們的衛生系統合作夥伴相結合，我們可以為拒絕其他更多 - 更好的篩查形式的人提供解決方案。因此，我們在 Cologuard 作為主導產品方面處於有利地位，我們認為增加血液檢測將有助於挽救生命，因為我們知道拒絕者是誰。

The final question comes from Alex Nowak of Craig-Hallum Capital Group.

最後一個問題來自 Craig-Hallum Capital Group 的 Alex Nowak。

Okay. Maybe to end on a note here about the upcoming Analyst Day. You have a lot going on, whether it be the BLUE-C study, MRD, focus on profitability. You shared a lot with us so far with these earnings calls here. But what new do you want to unveil at the Analyst Day, any preview?

好的。也許在這裡結束關於即將到來的分析師日的說明。你有很多事情要做，無論是 BLUE-C 研究，MRD，關注盈利能力。到目前為止，您在這里通過這些財報電話會議與我們分享了很多內容。但是你想在分析師日推出什麼新東西，預覽？

Alex, you have to come here for the good stuff. So we really can't wait to show off our team, our lab, our pipeline products, the commercial activities, it's -- we haven't had an Investor Day in, I think, it's 7 years. So we're really excited to bring everybody together and look forward to hosting you and other investors here in medicine.

亞歷克斯，你必須來這裡找好東西。所以我們真的迫不及待地想炫耀我們的團隊、我們的實驗室、我們的管道產品、商業活動，我想我們已經有 7 年沒有舉辦投資者日了。因此，我們非常高興能將大家聚集在一起，並期待在這裡招待您和其他醫學投資者。

There are no further questions at this time. I'll now turn the call back over to Mr. Conroy for its final moment.

目前沒有其他問題。我現在將把電話轉回給 Conroy 先生，最後一刻。

Since joining Exact Sciences in 2009, there are many accomplishments that bring me pride and make me thankful for being part of this team. Today's announcement of our Q1 results marks a high point. We made incredible progress in our mission of eradicating cancer and delivering great results for the shareholders who have supported and believed in us. The Exact Sciences team takes pride in innovation, quality, integrity, accountability. And most of all, we believe that teamwork fuels a culture that leads to superior results. The best part is yet to come in the Exact Sciences story. Thank you to all of the team members who made Q1 such a powerful quarter and we look forward to delivering again in the future. Thank you.

自 2009 年加入 Exact Sciences 以來，有許多成就讓我感到自豪，也讓我感謝成為這個團隊的一員。今天我們公佈的第一季度業績標誌著一個高點。我們在根除癌症的使命中取得了令人難以置信的進展，並為支持和信任我們的股東帶來了巨大的成果。 Exact Sciences 團隊以創新、質量、誠信和責任為榮。最重要的是，我們相信團隊合作能激發一種導致卓越結果的文化。 Exact Sciences 故事中最精彩的部分尚未出現。感謝所有使第一季度成為如此強大的季度的團隊成員，我們期待著在未來再次交付。謝謝。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。