Exact Sciences Corp (EXAS) 2024 Q2 法說會逐字稿

Thank you for standing by.

謝謝你的支持。

At this time, I would like to welcome everyone to today's Exact Sciences' second quarter 2024 earnings call.

此時此刻，我謹歡迎大家參加今天 Exact Sciences 的 2024 年第二季財報電話會議。

(Operator Instructions) I would now like to turn the call over to Erik Holznecht, Manager of Investor Relations.

（操作員說明）我現在想將電話轉給投資者關係經理 Erik Holznecht。

Erik, please go ahead.

埃里克，請繼續。

Thanks, operator.

謝謝，接線生。

Thank you for joining us for Exact Sciences' second quarter 2024 conference call.

感謝您參加 Exact Sciences 2024 年第二季電話會議。

On the call today are Kevin Conroy, the company's Chairman and CEO; and Aaron Bloomer, our Chief Financial Officer.

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)；以及我們的財務長 Aaron Bloomer。

Exact Sciences issued a news release earlier this afternoon detailing our second quarter financial results.

Exact Sciences 今天下午早些時候發布了一份新聞稿，詳細介紹了我們第二季的財務表現。

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.

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。

Our actual results may be materially different from such statements.

我們的實際結果可能與此類聲明有重大差異。

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.

我們的收益新聞稿中提供了對非 GAAP 數據的討論以及與 GAAP 數據的調節，並且與 Exact Sciences 相關的風險和不確定性的描述包含在我們向 SEC 提交的文件中。

Both can be accessed through our website.

兩者都可以透過我們的網站存取。

I'll now turn the call over to Kevin.

我現在將電話轉給凱文。

Thanks, Erik.

謝謝，埃里克。

Our second quarter results show the power of Exact Sciences platform and dedication of our world-class team.

我們第二季的業績展示了 Exact Sciences 平台的力量和我們世界一流團隊的奉獻精神。

For the first time, we screened over 1 million people in a quarter with Cologuard for colon cancer, the number two deadliest cancer in the US.

我們首次在一個季度內使用 Cologuard 對超過 100 萬人進行了結腸癌篩檢，這是美國第二大致命癌症。

We tested more patients globally with Oncotype DX than ever before.

我們在全球範圍內使用 Oncotype DX 測試的患者數量比以往任何時候都多。

Expanding and leveraging our platform led to record customer engagement.

擴展並利用我們的平台使客戶參與度創歷史新高。

During the second quarter, more than 190,000 health care providers ordered our preeminent cancer test.

第二季度，超過 190,000 名醫療保健提供者訂購了我們卓越的癌症檢測。

Over 350 health systems and oncology centers utilized Exact Nexus, our proprietary technology platform.

超過 350 個衛生系統和腫瘤中心使用了我們的專有技術平台 Exact Nexus。

We made significant progress toward launching Cologuard Plus, our next-generation Cologuard test and OncoDetect our molecular residual disease test.

我們在推出新一代 Cologuard 檢測 Cologuard Plus 和分子殘留疾病檢測 OncoDetect 方面取得了重大進展。

Our team also advanced several other key pipeline programs, including our blood-based colon cancer screening test and multi-cancer screening test.

我們的團隊還推進了其他幾個關鍵的管道項目，包括我們的基於血液的結腸癌篩檢測試和多種癌症篩檢測試。

The strength of our infrastructure, commercial reach, payer relationships and Exact Nexus allows us to offer these tests to millions of people around the world.

我們的基礎設施、商業覆蓋範圍、付款人關係和 Exact Nexus 的實力使我們能夠向世界各地數百萬人提供這些測試。

We delivered year-over-year core revenue growth of 13%, with a slight decline in operating expenses, leading to a record adjusted EBITDA of $110 million.

我們的核心營收年增 13%，營運費用略有下降，調整後 EBITDA 達到創紀錄的 1.1 億美元。

Other highlights from the second quarter include producing $71 million of free cash flow, a $5 million improvement, being recognized as a Great Place to Work for the sixth consecutive year and securing an exclusive license with rights to sublicense patented sequencing technologies.

第二季的其他亮點包括產生 7,100 萬美元的自由現金流、500 萬美元的改進、連續第六年被評為「最佳工作場所」以及獲得具有專利定序技術再許可權利的獨家許可。

These achievements reflect our dedication to helping eradicate cancer and we're well positioned to achieve our goals for the year.

這些成就反映了我們致力於幫助根除癌症的努力，我們完全有能力實現今年的目標。

Aaron will now review our second quarter results.

亞倫現在將回顧我們第二季的業績。

Thanks, Kevin, and good afternoon, everyone.

謝謝凱文，大家下午好。

Second quarter results highlight strong operational execution, and we're pleased with the progress we made.

第二季的業績凸顯了強勁的營運執行力，我們對所取得的進展感到滿意。

Second quarter revenue of $699 million grew 12% year-over-year or 13% on a core basis excluding COVID testing, FX and M&A.

第二季營收為 6.99 億美元，年增 12%，不包括新冠病毒測試、外匯和併購的核心營收成長 13%。

Growth was led by momentum and increased penetration of Cologuard, along with accelerated Oncotype DX growth internationally.

成長是由 Cologuard 的勢頭和滲透率的提高以及 Oncotype DX 在國際上的加速成長所帶動的。

Adjusted EBITDA margin expanded 500 basis points to a record 15.7%, and we generated $71 million in free cash flow.

調整後的 EBITDA 利潤率擴大了 500 個基點，達到創紀錄的 15.7%，我們產生了 7,100 萬美元的自由現金流。

Screening revenue increased 15% to $532 million.

放映收入成長 15%，達到 5.32 億美元。

We continue to see Cologuard orders consistently grow as health systems, health care professionals and payers increasingly embed the test into their practices.

隨著衛生系統、醫療保健專業人員和付款人越來越多地將測試嵌入到他們的實踐中，我們繼續看到 Cologuard 訂單持續成長。

We're proud of our sales and marketing teams and the work they are doing to drive adoption, especially within rescreens and care gap programs.

我們為我們的銷售和行銷團隊以及他們為推動採用所做的工作感到自豪，特別是在重新篩選和護理差距計劃方面。

Care gap programs generated more revenue in the first half of 2024 than all of 2023.

護理缺口計劃在 2024 年上半年產生的收入比 2023 年全年還要多。

Precision Oncology revenue grew 7% to $168 million or 6% on a core basis.

精準腫瘤學收入成長 7%，達到 1.68 億美元，核心收入成長 6%。

Growth was led by Oncotype DX, which expanded 31% internationally.

Oncotype DX 引領成長，其國際業務成長了 31%。

Our team has done significant work driving leverage and operational execution across the P&L.

我們的團隊在推動整個損益表的槓桿率和營運執行方面做了大量工作。

We generated $110 million in adjusted EBITDA, an increase of $43 million year-over-year or 65% growth.

我們的調整後 EBITDA 為 1.1 億美元，年增 4,300 萬美元，成長 65%。

Adjusted EBITDA margin expansion was driven by volume growth, productivity and expense controls especially within G&A, and we are pleased with this progress.

調整後的 EBITDA 利潤率擴張是由銷售成長、生產力和費用控制（尤其是一般管理費用控制）所推動的，我們對這一進展感到滿意。

This more than offset a decline in non-GAAP gross margin of about 190 basis points.

這足以抵消非 GAAP 毛利率約 190 個基點的下降。

Recall, gross margin in the second quarter of 2023 benefited from better cash collections due to improvements made to our billing systems that allowed us to correct claims from prior periods.

回想一下，2023 年第二季的毛利率得益於現金回款的改善，這是由於我們的計費系統得到了改進，使我們能夠更正前期的索賠。

To simplify modeling and increased clarity, we introduced a new reconciliation within our press release that presents operating income or loss on a GAAP and adjusted basis.

為了簡化建模並提高清晰度，我們在新聞稿中引入了新的調整表，該調整表按 GAAP 和調整後的基礎顯示營業收入或虧損。

Using both methodologies, total operating expenses declined slightly year-over-year during the second quarter.

使用這兩種方法，第二季的總營運費用較去年同期略有下降。

We continue to see opportunities to optimize costs and increase operational efficiency creating the capacity to reinvest back into growth areas while still expanding margins.

我們繼續看到優化成本和提高營運效率的機會，創造出再投資到成長領域的能力，同時仍擴大利潤率。

For example, during the second quarter, we reinvested some of our cost savings back into high-growth initiatives, including within sales and marketing.

例如，在第二季度，我們將部分節省的成本重新投入到高成長計畫中，包括銷售和行銷領域。

Free cash flow was $71 million, an increase of $5 million year-over-year and up $191 million sequentially.

自由現金流為 7,100 萬美元，年增 500 萬美元，季增 1.91 億美元。

We ended the quarter with cash and securities of $947 million.

本季結束時，我們擁有 9.47 億美元的現金和證券。

Our strong balance sheet and positive free cash flow outlook allowed us to repay the full $50 million outstanding balance of our AR securitization facility and secure an exclusive license with TwinStrand Biosciences.

我們強大的資產負債表和積極的自由現金流前景使我們能夠償還 AR 證券化工具的 5000 萬美元未償餘額，並獲得 TwinStrand Biosciences 的獨家許可。

Turning to guidance.

轉向指導。

We're maintaining our full year revenue guidance and raising our adjusted EBITDA guidance.

我們維持全年收入指引，並提高調整後的 EBITDA 指引。

We continue to expect full year revenue between $2.81 billion and $2.85 billion, and now expect adjusted EBITDA between $335 million and $355 million or 12.2% margin rate at midpoint.

我們仍預期全年營收在 28.1 億美元至 28.5 億美元之間，目前預計調整後 EBITDA 在 3.35 億美元至 3.55 億美元之間，即中點利潤率為 12.2%。

During the third quarter, we expect total revenue between $705 million and $725 million or year-over-year growth of 14% at midpoint.

我們預計第三季總營收將在 7.05 億美元至 7.25 億美元之間，中間年增 14%。

This assumes screening revenue between $545 million and $555 million or growth of 17% at midpoint and Precision Oncology revenue between $160 million and $170 million or growth of 6% at midpoint.

假設篩檢收入在 5.45 億美元到 5.55 億美元之間，或中點成長 17%，精準腫瘤學收入在 1.6 億美元到 1.7 億美元之間，或中點成長 6%。

Guidance applied 17% revenue growth year-over-year at midpoint in the second half of 2024 with 21% growth in screening and 6% growth in Precision Oncology.

指引指出，2024 年下半年中期營收年增 17%，其中篩檢成長 21%，精準腫瘤學成長 6%。

We expect second half Screening revenue to be about 54% of full year revenue, consistent with the historical average.

我們預計下半年放映收入將佔全年收入的 54% 左右，與歷史平均值一致。

Several key factors give us confidence in achieving guidance.

幾個關鍵因素讓我們有信心實現指導。

First, the number of people eligible for the next Cologuard test grows by more than 10% sequentially, and our REIT screen success rate continues to improve.

首先，有資格參加下一次 Cologuard 測試的人數較上季增加了 10% 以上，而且我們的 REIT 篩檢成功率持續提高。

We're making progress by sending patients digital reminders and educating providers about the option to order Cologuard in advance of a patient's three-year Cologuard anniversary.

我們透過在患者 Cologuard 週年紀念日之前向患者發送數位提醒並教育提供者有關訂購 Cologuard 的選項來取得進展。

Once a rescreen test is ordered more than 80% of second-time Cologuard users and 90% of third time users go on to complete the test again, demonstrating a high level of patient preference and satisfaction; second, we have more than 100 opportunities with payers and health systems to close care gaps with Cologuard through large organized screening programs.

一旦訂購重新篩選測試，超過 80% 的第二次 Cologuard 用戶和 90% 的第三次用戶會繼續再次完成測試，這表明患者的高度偏好和滿意度；其次，我們與付款人和衛生系統有 100 多個機會，透過大型有組織的篩檢計畫來縮小與 Cologuard 的照護差距。

We also expect recent sales and marketing investments will support growth in the second half of the year with a greater impact expected in the fourth quarter and the coming years.

我們也預計最近的銷售和行銷投資將支持下半年的成長，並預計在第四季度和未來幾年產生更大的影響。

Back to you, Kevin.

回到你身上，凱文。

Thanks, Aaron.

謝謝，亞倫。

Over the past decade, Cologuard has revolutionized colon cancer screening and momentum continues to build.

在過去的十年中，Cologuard 徹底改變了大腸癌篩檢，並且勢頭持續增強。

According to the CDC, Cologuard is the primary reason colon cancer screening rates have increased 13 percentage points.

據 CDC 稱，Cologuard 是結腸癌篩檢率提高 13 個百分點的主要原因。

We've delivered more than 16 million Cologuard test results to patients and we're just getting started.

我們已經向患者提供了超過 1600 萬份 Cologuard 測試結果，而我們才剛開始。

For example, we've screened more than 1.5 million people ages 45 to 49 since the screening age was lowered three years ago.

例如，自從三年前降低篩檢年齡以來，我們已經對超過 150 萬名 45 至 49 歲的人進行了篩檢。

Keeping these people screened until their 85 provides up to 20 million Cologuard testing opportunities.

對這些人進行篩檢直至他們 85 歲，可提供多達 2000 萬次 Cologuard 測試機會。

Cologuard has become an embedded standard of care among patients health care providers, health systems and payers.

Cologuard 已成為患者醫療保健提供者、衛生系統和付款人的嵌入式護理標準。

We're using our unparalleled commercial capabilities and powerful Exact Nexus platform to engage patients through personalized experiences.

我們利用無與倫比的商業能力和強大的 Exact Nexus 平台透過個人化體驗吸引患者。

This is resulting in more patients completing Cologuard every three years, helping us achieve our goal of making screening routine.

這導致更多的患者每三年完成一次 Cologuard，幫助我們實現常規篩檢的目標。

It's also playing a key role in our new approach to closing the screening gap.

它也在我們縮小篩選差距的新方法中發揮關鍵作用。

Let me give you an example.

讓我舉個例子。

One of our customers, a major payer asked us to help screen 90,000 of their members with a goal of providing better care and improving their quality measure scores.

我們的一位客戶（主要付款人）要求我們幫助篩選其 90,000 名會員，目標是提供更好的護理並提高他們的品質衡量分數。

Exact Sciences' state-of-the-art patient engagement tools in Exact Nexus guided and supported patients throughout the screening process, promoting adherence.

Exact Sciences 在 Exact Nexus 中最先進的患者參與工具在整個篩檢過程中指導和支持患者，促進依從性。

Our customer was thrilled with the outcome, and we're already in discussions with them and many others about future care gap programs.

我們的客戶對結果感到非常興奮，我們已經與他們和許多其他人討論未來的護理缺口計劃。

Our Precision Oncology team is doing an outstanding job expanding the impact of Oncotype DX internationally.

我們的精準腫瘤學團隊正在出色地擴大 Oncotype DX 在國際上的影響力。

We still have a major opportunity to provide important answers to eligible patients outside the US because about 70% aren't currently being tested.

我們仍然有很大的機會為美國以外符合條件的患者提供重要答案，因為大約 70% 的患者目前尚未接受檢測。

Healthcare professionals, hospitals and health systems trust Oncotype DX because it's supported by unmatched evidence.

醫療保健專業人士、醫院和衛生系統信任 Oncotype DX，因為它有無與倫比的證據支持。

Oncotype DX is globally recognized as a standard of care and included in all major guidelines.

Oncotype DX 是全球公認的護理標準，並包含在所有主要指南中。

Thanks to our team's commitment, we've increased Oncotype DX adoption internationally by about 10 percentage points over the past year.

感謝我們團隊的承諾，去年我們將 Oncotype DX 在國際上的採用率提高了約 10 個百分點。

We're making strong progress internationally, and our goal is to make sure all people eligible for Oncotype DX have access around the world.

我們在國際上取得了巨大進展，我們的目標是確保世界各地所有符合 Oncotype DX 資格的人都可以使用。

Expanding our presence globally also provides opportunities across our portfolio, which we're working towards.

擴大我們的全球業務也為我們的產品組合提供了機會，我們正在努力實現這一目標。

The second quarter was a hallmark period for our pipeline as we advanced our most impactful programs, colon cancer screening, molecular residual disease testing and multi-cancer screening.

第二季度是我們產品線的標誌性時期，我們推進了最有影響力的項目：結腸癌篩檢、分子殘留疾病檢測和多癌症篩檢。

We plan to share performance data from each of these programs by the end of the year.

我們計劃在今年年底前分享每個專案的績效數據。

Cologuard Plus will be the most efficient, noninvasive way to screen for colon cancer and we anticipate FDA approval in the coming months.

Cologuard Plus 將是最有效、非侵入性的大腸癌篩檢方法，我們預計 FDA 將在未來幾個月內獲得批准。

Cologuard Plus sets a new performance standard with 94% overall cancer sensitivity. 43% sensitivity for advanced precancerous lesions, 91% specificity when including patients with small polyps and other incidental findings and 93% specificity with no findings on colonoscopy.

Cologuard Plus 設定了新的性能標準，整體癌症敏感性為 94%。對於晚期癌前病變的敏感性為 43%，當包括小息肉和其他偶然發現的患者時，特異性為 91%，對於大腸鏡檢查未發現任何發現的患者，特異性為 93%。

This means the test achieved a 30% lower false positive rate relative to current Cologuard with cancer and precancerous lesion detection improving as well.

這意味著與目前的 Cologuard 相比，該測試的假陽性率降低了 30%，並且癌症和癌前病變檢測也得到了改善。

Cologuard Plus could save the health care system billions of dollars for two reasons: one, Cologuard Plus presents an opportunity to further reduce colon cancer incidence and mortality, moving us one step closer towards helping eradicate this disease.

Cologuard Plus 可以為醫療保健系統節省數十億美元，原因有兩個：第一，Cologuard Plus 提供了進一步降低結腸癌發病率和死亡率的機會，使我們在幫助根除這種疾病的道路上更近了一步。

Two, fewer patients will be sent to unnecessary follow-up colonoscopies.

第二，較少的患者將被送往不必要的後續大腸鏡檢查。

We recently ran our blood-based colon cancer screening test on more than 3,000 samples.

我們最近對 3,000 多個樣本進行了基於血液的結腸癌篩檢測試。

The study consisted of 2,900 prospectively collected samples from healthy individuals, 90 advanced adenomas, the majority of which were collected prospectively and 60 retrospectively collected cancer samples.

研究包括 2,900 份來自健康個體的前瞻性樣本、90 份晚期腺瘤樣本（其中大部分是前瞻性樣本）以及 60 份回顧性樣本。

The results give us confidence our test will be at least comparable to others and will meet the Medicare requirements.

結果讓我們相信我們的測試至少與其他測試具有可比性，並且符合醫療保險要求。

We plan on presenting these data before sharing top line results from our pivotal BLUE-C study in the fourth quarter of 2024.

我們計劃在 2024 年第四季分享我們關鍵 BLUE-C 研究的主要結果之前展示這些數據。

Our blood-based colon cancer screening test will have an unrivaled cost profile.

我們的基於血液的結腸癌篩檢測試將具有無與倫比的成本。

Once available, it will be supported by our commercial infrastructure, patient navigation engine and Exact Nexus technology platform, making ordering and resulting seamless for more than 350 health systems and available to our broad and deep customer base of health care providers.

一旦推出，它將得到我們的商業基礎設施、患者導航引擎和Exact Nexus 技術平台的支持，為350 多個衛生系統提供無縫訂購和結果，並為我們廣泛而深入的醫療保健提供者客戶群提供服務。

OncoDetect, our molecular residual disease test will significantly impact decision-making, and we're supporting it with high-quality clinical evidence.

OncoDetect，我們的分子殘留疾病測試將顯著影響決策，我們用高品質的臨床證據支持它。

Our team recently generated impressive study results, demonstrating OncoDetect is highly accurate at detecting residual disease in colon cancer patients.

我們的團隊最近取得了令人印象深刻的研究結果，證明 OncoDetect 在檢測結腸癌患者的殘留疾病方面高度準確。

These findings will be published in a scientific journal later this year, and we're on track to launch OncoDetect with reimbursement next year 2025.

這些研究結果將於今年稍晚發表在科學期刊上，我們預計將在明年 2025 年推出可報銷的 OncoDetect。

We also strengthened our patent portfolio by signing an exclusive license to TwinStrand's cell free nucleic acid sequencing technologies.

我們也透過簽署 TwinStrand 無細胞核酸定序技術的獨家授權來加強我們的專利組合。

This license provides near- and long-term opportunities across multiple areas of cancer diagnostics while complementing our existing IP, including Thrives, safety, and safer seek technologies.

該許可證提供了癌症診斷多個領域的近期和長期機會，同時補充了我們現有的智慧財產權，包括 Thrives、安全性和更安全的尋求技術。

Our multi-cancer screening test was recently authorized by the FDA to be used within a real-world evidence study providing an opportunity to test 25,000 people over the next 3 years.

我們的多種癌症篩檢測試最近獲得 FDA 授權，用於一項現實世界的證據研究，為未來 3 年內對 25,000 人進行測試提供了機會。

Generating real-world evidence in a clinical setting will help optimize clinical workflows and support discussions with regulatory agencies, payers and guideline groups.

在臨床環境中產生真實世界的證據將有助於優化臨床工作流程並支持與監管機構、付款人和指南小組的討論。

Our data presentation at the AACR meeting in April showed our multi-cancer screening test detected 51% of cancers at 98.5% specificity across 21 types of cancer in a large, well-designed study. 16 of those cancer types have no standard of care screening option available today.

我們在 4 月的 AACR 會議上展示的數據顯示，在一項精心設計的大型研究中，我們的多癌症篩檢測試在 21 種癌症中檢測出了 51% 的癌症，特異性為 98.5%。其中 16 種癌症目前尚無標準護理篩檢選項。

Next, we plan to present improved performance data at a scientific conference later this year, highlighting the benefits of combining this approach with Thrive's technology.

接下來，我們計劃在今年稍後的科學會議上展示改進的績效數據，強調將此方法與 Thrive 技術相結合的好處。

Our focus on helping eradicate cancer powers the Exact Sciences' team, creating momentum within our business and allowing us to extend our platform.

我們專注於幫助根除癌症，這為 Exact Sciences 團隊提供了動力，為我們的業務創造了動力，並使我們能夠擴展我們的平台。

Continued execution our growing portfolio of tests and a leading presence in cancer screening and precision oncology put us in a prime position to achieve our purpose.

繼續執行我們不斷增長的測試組合以及在癌症篩檢和精準腫瘤學方面的領先地位，使我們處於實現目標的首要位置。

We're now happy to take your questions.

我們現在很樂意回答您的問題。

(Operator Instructions) Patrick Donnelly, Citi.

（操作員指示）Patrick Donnelly，花旗銀行。

Kevin, maybe on the cost side, obviously, last quarter, the increase in rep hire has got a lot of attention.

凱文，也許在成本方面，顯然，上個季度，銷售代表招募的增加引起了很多關注。

Profitability is nice to see here, and I can see the EBITDA move higher.

盈利能力很好，我可以看到 EBITDA 上升。

Can you just talk through the key drivers there?

您能談談那裡的關鍵驅動因素嗎？

And if anything has changed here in your confidence in long-term expectations, just that trend line on the profitability piece.

如果您對長期預期的信心發生了任何變化，那就是獲利能力部分的趨勢線。

And then second, I certainly appreciate the update on your internal blood program.

其次，我當然很感謝你們內部血液計畫的最新進展。

That market continues to get a lot of attention given the FDA approval last week for a competitor.

鑑於 FDA 上週批准了其競爭對手，該市場繼續受到廣泛關注。

Just how you think about your approach there on the cost commercialization side?

您如何看待成本商業化方面的方法？

It sounds like you're confident your data stacks up with anything out there.

聽起來您對自己的數據與現有的任何數據都相符充滿信心。

And the TwinStrand agreement, it doesn't seem like it changed anything on that front.

而 TwinStrand 協議似乎並沒有改變這方面的任何內容。

I guess that's just related.

我想這只是相關的。

I just want to confirm that.

我只是想確認一下。

Yes.

是的。

Why don't I start with the first one and really excited about the growth that we're seeing, 15% screening growth, record 16% adjusted EBITDA margins, thrilled across the board with what the team is doing to grow screening to grow precision oncology that is leading to tremendous growth in EBITDA, and we expect that to continue.

為什麼我不從第一個開始，對我們所看到的增長感到非常興奮，15% 的篩選增長，創紀錄的16% 調整後EBITDA 利潤率，對團隊為增加篩選以提高精度所做的努力感到全面興奮腫瘤學正在導致 EBITDA 的巨大增長，我們預計這種情況將持續下去。

Looking at the driver of growth really focusing in on the screening, there are three things.

從真正關注放映的成長驅動力來看，有三件事。

The increasing brand awareness of Cologuard that it's the best noninvasive approach to screening.

Cologuard 的品牌知名度不斷提高，認為它是最佳的非侵入性篩檢方法。

It is now at parity with colonoscopy in terms of consumer awareness, really remarkable.

就消費者認知度而言，它現在與大腸鏡檢查相當，確實了不起。

And we're pleased to see that our commercial engine is doing great work.

我們很高興看到我們的商業引擎正在發揮出色的作用。

We expect even better performance in the back half of the year moving into next year.

我們預計下半年到明年會有更好的表現。

Our deepening relationship with health systems, primary care physicians, payers just across the board strength there.

我們與衛生系統、初級保健醫生、付款人之間不斷加深的關係在這方面具有全面的優勢。

And also, we're extending and leveraging our Exact Nexus platform.

此外，我們正在擴展和利用我們的 Exact Nexus 平台。

That platform allows us to reach electronically 350 health systems in the US, making ordering easier that will continue to grow and deepen over the years.

該平台使我們能夠透過電子方式聯繫美國 350 個醫療系統，使訂購變得更加容易，並且這個平台將在未來幾年繼續增長和深化。

And as we add our portfolio to that platform, that allows us to deliver even greater cost economics as we grow, Aaron, you probably have more in-depth analysis there.

當我們將我們的產品組合添加到該平台時，這使我們能夠隨著我們的發展提供更大的成本經濟效益，亞倫，您可能會在那裡進行更深入的分析。

Yes.

是的。

Great.

偉大的。

Thanks, Kevin.

謝謝，凱文。

First of all, really pleased with the progress that the team delivered in the second quarter, as Kevin mentioned, record levels of adjusted EBITDA, both on a dollar basis as well as 16% on a margin basis.

首先，我們對團隊在第二季的進展感到非常滿意，正如 Kevin 所提到的，調整後 EBITDA 創歷史新高，無論是以美元計算還是按利潤計算 16%。

And kind of unpacking that a little bit.

並稍微解開一下。

It starts with growth, double-digit revenue growth, 15% growth from screening, and you couple that with just outstanding strong operational execution, especially within G&A.

首先是成長，兩位數的營收成長，放映後 15% 的成長，然後再加上出色的強大營運執行力，尤其是在 G&A 方面。

And that kind of then informs from a full year guide perspective as well as long term, this allowed us -- the execution we delivered in the second quarter allowed us to raise our full year adjusted EBITDA guidance.

從全年指導的角度以及長期來看，這使我們能夠——我們在第二季度交付的執行使我們能夠提高全年調整後的 EBITDA 指導。

And if you look at that, that implies about a 500 basis point margin expansion in the back half of the year, and a majority of that leverage is going to come from G&A.

如果你看一下，這意味著今年下半年的利潤率將擴大約 500 個基點，而大部分槓桿將來自 G&A。

And the exciting thing for us about this is it creates the capacity for us to reinvest back into our highest ROI areas, notably MRD and marketing in the back half of 2024.

對我們來說，令人興奮的是，它使我們有能力在 2024 年下半年重新投資於投資回報率最高的領域，特別是 MRD 和行銷。

So we feel great.

所以我們感覺很棒。

I think we're in a great position to exceed our 2027 adjusted EBITDA target of 20%-plus.

我認為我們完全有能力超越 2027 年 20% 以上的調整後 EBITDA 目標。

Patrick, I'll also address the CRC blood question, as you know, our test Cologuard Plus sets a whole new standard of care.

帕特里克，我還將解決 CRC 血液問題，如您所知，我們的 Cologuard Plus 測試設定了全新的護理標準。

On top of Cologuard, we've set a new standard of care.

在 Cologuard 的基礎上，我們制定了新的護理標準。

And Cologuard Plus, 94% CRC sensitivity, 93%, what we call Category 6 specificity and 43% adenoma sensitivity.

而 Cologuard Plus，CRC 敏感性為 94%，我們所說的 6 類特異性為 93%，腺瘤敏感性為 43%。

So incredible test.

如此令人難以置信的測試。

We think that blood test faced some real challenges, namely performance.

我們認為血液檢測面臨一些真正的挑戰，即性能。

And to net out the performance sensitivity and specificity, just look at light years gained.

為了消除性能敏感性和特異性，只需看看所獲得的光年即可。

And when you take a look at Cologuard compared to blood test performance, and you can see this in one of the publications or a poster that was presented at DDW, blood test had fewer life years gained relative to Cologuard or Cologuard Plus.

當您將 Cologuard 與血液測試性能進行比較時，您可以在 DDW 上展示的出版物或海報中看到這一點，相對於 Cologuard 或 Cologuard Plus，血液測試獲得的生命年更少。

That's a huge step down in screening, and it's actually inferior to $25 FIT test.

這在篩選方面是一個巨大的進步，而且實際上不如 25 美元的 FIT 測試。

So we think there are real challenges.

所以我們認為有真正的挑戰。

One of the challenges is the challenge of getting into guidelines, which is looking like it's at best late '26, but probably more likely 2027 is when the next guideline update would be not included in HEDIS measures, et cetera.

挑戰之一是納入指南的挑戰，這看起來最多要到 26 年末，但更有可能是 2027 年，下一次指南更新將不包含在 HEDIS 措施中，等等。

And there are really limitations here because of that performance difference.

由於性能差異，這裡確實存在限制。

And it matters.

這很重要。

I mean you're talking about people's lives and how they're screened.

我的意思是，你談論的是人們的生活以及他們是如何被篩選的。

And the way that Exact Sciences thinks about the appropriate role for a blood test, our own blood test is for people who refuse colonoscopy or refuse Cologuard or even for that matter, refuse a FIT test.

Exact Sciences 認為血液檢查的適當作用的方式是，我們自己的血液檢查是針對那些拒絕大腸鏡檢查或拒絕 Cologuard 甚至拒絕 FIT 測試的人。

An expensive blood test that is basically blind to precancerous polyps, we don't believe is going to be widely adopted by guideline groups, by payers and ultimately by premier care physicians.

這是一種昂貴的血液檢測，基本上對癌前息肉視而不見，我們認為它不會被指南團體、付款人以及最終的高級護理醫生廣泛採用。

Our blood test is -- as we referenced in the comments we ran a 3,000-patient study.

我們的血液檢查是——正如我們在評論中提到的，我們進行了一項 3,000 名患者的研究。

We really like the performance that we see.

我們真的很喜歡我們看到的表演。

That study helped us to find the final algorithm that will be used when we process the BLUE-C samples that will be used to submit to the FDA.

這項研究幫助我們找到了處理 BLUE-C 樣本並提交給 FDA 時使用的最終演算法。

That algorithm is important because you want to run it on as many samples as possible to narrow any fluctuation in performance that you will see in the pivotal study.

該演算法很重要，因為您希望在盡可能多的樣本上運行它，以縮小您在關鍵研究中看到的效能波動。

Now we don't know what those results will be.

現在我們不知道這些結果會是什麼。

We can't guarantee it, it's science.

我們不能保證，這是科學。

But this large study gives us a tremendous amount of confidence going into what we expect to see in the fourth quarter is the pivotal study results.

但這項大型研究讓我們對第四季的關鍵研究結果充滿信心。

So more to share -- we'll share the results of this study, this more recent study sometime before we release the results of the pivotal study.

因此，還有更多值得分享的內容——我們將在發布關鍵研究結果之前的某個時間分享這項研究的結果，這項最新的研究。

Finally, I think you asked the third question.

最後，我想你問了第三個問題。

And please, I know somebody else would probably asked this question about TwinStrand.

我知道其他人可能會問這個關於 TwinStrand 的問題。

TwinStrand IP complements the portfolio that we have, and it essentially at a high level, covers duplex sequencing and reducing error rates and next-generation sequencing for cell-free DNA.

TwinStrand IP 補充了我們現有的產品組合，它本質上在高水平上涵蓋了雙工測序、降低錯誤率以及無細胞 DNA 的新一代測序。

It strengthens our portfolio.

它增強了我們的產品組合。

It's proven intellectual property, and we're excited to be the new owners.

它是經過驗證的智慧財產權，我們很高興成為新所有者。

Tycho Peterson, Jefferies.

第谷·彼得森，杰弗里斯。

A couple on Cologuard plus, Kevin, just thinking about the phase-in process, how you'll handle the transition, when you'll be fully transitioned?

凱文（Kevin）是 Cologuard plus 上的一對夫婦，正在考慮分階段過程，您將如何處理過渡，何時完全過渡？

And just practically, how does that work?

實際上，這是如何運作的？

Do doctors offer patients want test based on coverage and another based on their coverage?

醫生是否會根據承保範圍向患者提供想要的檢查，並根據他們的承保範圍提供另一項檢查？

And then any feedback on pricing versus the 25% ask as you've been out having more conversations?

當你們出去進行更多對話時，與 25% 的詢問相比，有什麼關於定價的反饋嗎？

And are you still thinking Crosswalk.

你還在考慮Crosswalk嗎？

And then I think you said you only need to add 100, 150 reps for MRD.

然後我想你說過你只要為 MRD 增加 100、150 次。

So switching over to MRD.

所以切換到 MRD。

Why is that the case, given that Genomic Health was -- it was mostly Ob/GYNs.

為什麼會出現這種情況，因為基因組健康主要是婦產科醫師。

And then two other quick ones.

然後還有另外兩個快速的。

Just on blood.

就靠血了。

Why not release the study results now, why wait till later in the fall?

為什麼不現在就發布研究結果，為什麼要等到秋季晚些時候呢？

And then can you address the issue of drawbacks of a PCR-based test versus sequencing Obviously, there's a view that sequencing can get better over time with algorithms?

然後您能否解決基於 PCR 的測試與定序相比的缺點問題？

Tycho, it's great to have you on board, keeping track of all that questions.

第谷，很高興您能加入並追蹤所有這些問題。

I can't promise you all do that perfectly.

我不能保證你們都能完美地做到這一點。

Let me start with blood.

讓我從血開始。

We'll release that data.

我們將發布該數據。

We're looking at the appropriate scientific conference to have that data and we'll release the top line data as soon as we can.

我們正在尋找合適的科學會議來獲取這些數據，我們將盡快發布最重要的數據。

In terms of Cologuard Plus, we're still working through exactly what the commercial deployment will be.

就 Cologuard Plus 而言，我們仍在研究商業部署的具體內容。

At a high level, what we're trying to achieve is to make sure that the transition in insurance coverage, which will take some time will map to the transition and utilization.

從較高的層面來看，我們試圖實現的目標是確保保險範圍的過渡（這需要一些時間）能夠映射到過渡和利用。

And our lab team and our commercial team are working through plans to do that.

我們的實驗室團隊和商業團隊正在製定計劃來實現這一目標。

It probably takes 12 to 24 months before all of the contracts we have with payers convert from Cologuard to Cologuard Plus.

我們與付款人簽訂的所有合約可能需要 12 到 24 個月才能從 Cologuard 轉換為 Cologuard Plus。

The first part of that journey is setting a new rate with Medicare.

旅程的第一部分是透過醫療保險設定新的費率。

There are multiple paths that we can go down to do that.

我們可以透過多種途徑來做到這一點。

One is the public process that you're seeing, which actually takes a while to play out.

其中之一是您所看到的公共流程，這實際上需要一段時間才能完成。

So I'd caution against any public information that either we released or was released by Medicare ultimately, towards the end of this year, there's a final decision on that current path.

因此，我要警惕我們發布的或 Medicare 最終發布的任何公開信息，到今年年底，當前路徑將做出最終決定。

There are other paths to pursue as well.

還有其他途徑可以追求。

Bottom line is Cologuard Plus delivers real value to people getting screened because of a lower false positive rate, because of a higher rate of detection of cancer and precancerous polyps, it's a better test.

最重要的是，Cologuard Plus 為接受篩檢的人帶來了真正的價值，因為它的假陽性率較低，而且癌症和癌前息肉的檢出率較高，這是更好的測試。

That leads to better outcomes.

這會帶來更好的結果。

It also leads to cost savings, for example, a 30% lower false positive rate leads to fewer people going to unnecessary colonoscopies, while keeping sensitivity actually slightly higher than with Cologuard.

它還可以節省成本，例如，誤報率降低 30%，從而減少進行不必要的大腸鏡檢查的人數，同時保持靈敏度實際上略高於 Cologuard。

And that's the magic of the technology that this team has worked, and that's our proprietary modification of kind of a super advanced PCR technology that helps us deliver those results with just a few DNA methylation markers and a protein.

這就是這個團隊所工作的技術的魔力，這是我們對超級先進 PCR 技術的專有修改，幫助我們僅用一些 DNA 甲基化標記和蛋白質即可獲得這些結果。

So hopefully, touch upon that in terms of MRD reps, I'm not sure that I understood that question, but maybe we can come back to that later.

因此，希望從 MRD 代表的角度談談這個問題，我不確定我是否理解這個問題，但也許我們可以稍後再討論這個問題。

Andrew Brackmann, William Blair.

安德魯·布拉克曼，威廉·布萊爾。

Maybe just on rescreens.

也許只是在重新放映。

Aaron, you outlined the opportunity here increasing in the second half and gave some compelling compliance numbers as well.

亞倫，您概述了下半年增加的機會，並提供了一些令人信服的合規數據。

So I guess it sounds like the main hurdle is actually getting those repeat tests ordered.

所以我想聽起來主要的障礙實際上是訂購重複測試。

So can you maybe just level set us on the initiatives that you have to get those ordered by docs?

那麼，您能否向我們介紹一下您必須按文件訂購的舉措？

And anything incremental that we should expect in terms of investment to that in the second half of this year?

今年下半年的投資預計會有什麼增量？

Andrew, great to hear from you.

安德魯，很高興收到你的來信。

Yes, So Rescreens is an important part of our growth story.

是的，So Rescreens 是我們成長故事的重要組成部分。

The number of patients eligible for rescreen grows this year from 1.2 million to 1.6 million. for the full year.

今年符合重新篩檢資格的患者人數從 120 萬人增加到 160 萬人。全年。

And we saw strong growth from rescreens coming in the second quarter.

我們看到第二季重映的強勁成長。

And as we said, the back half of the year is actually up sequentially versus the first half of the year by roughly 10%.

正如我們所說，今年下半年的業績實際上比上半年成長了約 10%。

And we're getting better and better at engaging with these patients via my chart, our advanced ordering portal, bringing them into the Exact Nexus platform.

我們越來越擅長透過我的圖表（我們的高級訂購入口網站）與這些患者互動，將他們帶入 Exact Nexus 平台。

And once the patient orders the test, the second time it's at 80% adherence rate and the third time is now north of 90%.

一旦患者訂購了測試，第二次的遵守率就達到了 80%，而第三次的遵守率現在已超過 90%。

So again, we're finding new and creative ways to engage with our patients.

同樣，我們正在尋找新的、創意的方式來與患者互動。

Catherine Schulte, Baird.

凱瑟琳舒爾特，貝爾德。

Maybe first, you mentioned care gap programs a few times.

也許首先，您多次提到護理缺口計劃。

I guess, what are care gap assumptions and guidance, how is that weighted between the third and fourth quarter?

我想，護理差距假設和指導是什麼，第三季和第四季之間的權重如何？

And then just going back to your blood program, do you have a time line for when you expect to run this pivotal standpoint -- walk us through the steps that you need to complete before you run those.

然後回到您的血液計劃，您是否有一個預計何時運行這個關鍵觀點的時間表 - 讓我們完成您在運行這些之前需要完成的步驟。

I'll start.

我開始吧。

The care gap program is an important program.

護理差距計劃是一項重要計劃。

What you're seeing -- and this has been a 10-year, decade-long change in the way health care is consumed in the US that you're seeing a decline in office visits where many wellness visits or wellness visits are primarily conducted and screenings are conducted.

你所看到的——這是美國醫療保健消費方式十年來的一個變化，你看到辦公室就診次數減少，而許多健康就診或主要進行健康就診並進行篩選。

And what we're seeing is health systems and payers are coming to us and saying, hey, can you help us with this dynamic?

我們看到的是衛生系統和付款人來找我們說，嘿，你能幫我們解決這個問題嗎？

And can we get colon cancer screening done remotely in the privacy of people's home.

我們能否在人們家中遠端進行大腸癌篩檢？

And that what we call care gap program drives quality measures, which are really important to help large health systems and to payers across the country.

我們所說的護理差距計劃推動了品質措施，這對於幫助大型衛生系統和全國各地的付款人來說非常重要。

What we're doing here to help them is to engage with them to deliver directly to their members, to their patients the Cologuard test and the privacy of their own home, so that can be completed.

我們在這裡幫助他們所做的就是與他們接觸，直接向他們的會員、他們的患者提供 Cologuard 測試以及他們自己家中的隱私，以便能夠完成。

And so our Exact Nexus platform, our customer care capability, our digital capabilities are allowing us to serve these patients as they consume health care in a very different way.

因此，我們的 Exact Nexus 平台、我們的客戶服務能力、我們的數位能力使我們能夠為這些患者提供服務，因為他們以一種非常不同的方式消費醫療保健。

And we're seeing strong growth.

我們看到了強勁的成長。

An interesting dynamic here is that the growth tends to occur in a significant way from the early part of the year towards the end of the year.

這裡的一個有趣的動態是，從年初到年底，成長往往會以顯著的方式發生。

One of the drivers is that health systems and payers see a sneak preview of their quality measure scores in the middle of the year, driving to a lot of activity to improve their scores by the end of the year, and that's an awfully busy time for us in care gap program.

其中一個驅動因素是，衛生系統和付款人會在年中預覽他們的品質衡量分數，從而在年底前開展大量活動來提高他們的分數，而這對醫療機構來說是一個非常忙碌的時期。參與護理缺口計劃。

So we expect the step-up to be -- Q3 a real step up from Q2 and Q4, the biggest step up.

因此，我們預計第三季的進步將是第二季和第四季的真正進步，是最大的進步。

That's what we saw last year.

這就是我們去年看到的情況。

Aaron?

亞倫？

Yes.

是的。

No, you hit on it.

不，你擊中了它。

It's going to be more 4Q weighted consistent with what we saw in 2023.

第四季的權重將與我們在 2023 年看到的更加一致。

I would just reiterate we have a lot of confidence and visibility into the pipeline.

我只想重申，我們對管道充滿信心和可見性。

We've already done more revenue in the first half of 2024 than we did in all of 2023.

我們 2024 年上半年的收入已經超過了 2023 年全年的收入。

Then you asked a question about what do we need to do before running the pivotal samples.

然後您問了一個關於在運行關鍵範例之前我們需要做什麼的問題。

You do have to do a lot of software work to validate all the algorithms so that they work perfectly.

您確實必須做大量的軟體工作來驗證所有演算法，以便它們完美運作。

You have to process the between 10,000 and 20,000 samples that are frozen and banked, the automation, all of the lab, reagent QC, kind of the list goes on and on.

您必須處理 10,000 到 20,000 個冷凍和儲存的樣本、自動化、所有實驗室、試劑 QC，諸如此類的例子不勝枚舉。

You have one shot at doing this and you want to do it perfectly.

你有一次機會去做這件事，並且你想把它做得完美。

So the team, so proud of the team and what they have done here in developing the test, the clinical affairs team that has run the clinical trial and it's the largest and we think broadest clinical trial in this field, both stool and blood comparing to the FIT test, which is one thing that we insisted on doing.

因此，這個團隊對這個團隊以及他們在開發測試方面所做的工作感到非常自豪，臨床事務團隊已經進行了臨床試驗，這是該領域最大的，我們認為是該領域最廣泛的臨床試驗，與糞便和血液相比FIT測試，這是我們堅持要做的一件事。

So we're really looking forward to doing that and announcing the results in the fourth quarter.

因此，我們非常期待這樣做並在第四季度宣布結果。

And just to be clear, we have not processed those samples yet.

需要澄清的是，我們還沒有處理這些樣本。

When we process the samples, we will -- and we see the data, it will be a quick turnaround to announcing top line results and then presenting the data at a scientific conference and getting them into a publication.

當我們處理樣本時，我們會——並且我們會看到數據，這將是一個快速的周轉，宣布主要結果，然後在科學會議上展示數據並將其發表。

Matt Sykes, Goldman Sachs.

馬特·賽克斯，高盛。

I just wanted to ask on the Q3 guide, Aaron, it just came in a little bit below our expectations.

我只是想問一下第三季的指南，Aaron，它只是比我們的預期稍微低了一點。

Is that sort of reflecting some of the seasonality plus care gap in Q4 and that's where that revenue goes in terms of making that full year guide?

這是否反映了第四季度季節性加護理方面的差距，而這就是製作全年指南時收入的來源？

And then just secondly, on modeling, is there any way you can break out the prevention genetics from the overall screening revenue in the quarter?

其次，在建模方面，有什麼方法可以從本季的整體篩檢收入中分離出預防遺傳學嗎？

Yes.

是的。

So again, rescreens is going to drive more growth in Q3 and Q4.

因此，重新篩選將再次推動第三季和第四季的成長。

That's going to be more Q4 weighted care gap programs, as we just talked about, will be more Q4 weighted, although it's a sequential step-up from Q2 to Q3.

正如我們剛才談到的，第四季的加權護理缺口計劃將會更多，儘管這是從第二季到第三季的連續升級。

And the other thing I would just say is we know this market very well.

我想說的另一件事是我們非常了解這個市場。

We've seen consistently the steepest part of the growth curve really occurs from mid-August through November as wellness visits accelerate coming out of the summer, and that kind of informed than what we put into our back half of the year guide as well as our sequential step up Q2 to Q3 and then into Q4, consistent with prior year averages.

我們一直看到成長曲線最陡峭的部分確實發生在 8 月中旬到 11 月，因為夏季結束後健康訪問加速，這比我們在下半年指南和我們的業績連續從第二季度上升到第三季度，然後進入第四季度，與去年的平均水平一致。

Dan Arias, Stifel.

丹·阿里亞斯，斯蒂菲爾。

Kevin, I just wanted to go back to the USPSTF process, if I could.

Kevin，如果可以的話，我只是想回到 USPSTF 流程。

When those guys updated the guidelines in 2021, how far before that, I believe it was May of that year.

當那些人在 2021 年更新指南時，距離那之前有多遠，我相信那年 5 月。

How much before that did you hear from them first in terms of their data collection efforts?

在此之前您多久之前第一次收到他們關於資料收集工作的消息？

And do you think that it's any sooner or later than that this time around, essentially, when are you expecting to first hear them reach out to you on this process?

您認為這次是早還是晚？

Here's how the USPSTF process basically works.

以下是 USPSTF 流程的基本運作方式。

And let me tell you what USPSTF is for.

讓我告訴你 USPSTF 的用途。

So USPSTF, the United States Preventive Services Task Force is a group of volunteer, primary care physician, nurses, preeminent leaders, who think about prevention and ultimately opine on dozens and dozens of different topics from vaccines to screening.

因此，USPSTF（美國預防服務工作小組）是一個由志工、初級保健醫生、護理師和傑出領導者組成的團隊，他們思考預防問題，並最終就從疫苗到篩檢的數十個不同主題發表意見。

And what they typically do is start with a research plan that gets published.

他們通常所做的就是從發布的研究計劃開始。

They look at the research plan, two things are generated a modeling report and a literature review.

他們查看研究計劃，產生兩件事：建模報告和文獻綜述。

So a deep survey of studies and the literature, the evidence that has been generated since the last update that they then issue a draft guidance and then usually within about six months after that, they issued final guidance.

因此，對研究和文獻進行了深入調查，自上次更新以來產生的證據，然後他們發布了指導草案，然後通常在大約六個月內發布了最終指導。

That whole process is about a 2.5- to 3-year process.

整個過程大約需要2.5到3年的時間。

They meet on any of the individual topics about every -- they shoot for every five years with colon cancer screening, it has ranged between five years and eight years.

他們就每個主題進行會面——他們每五年拍攝一次大腸癌篩檢，範圍從五年到八年不等。

So the -- it's not like clockwork every five years.

所以，這並不像每五年一次發條一樣。

It varies based upon how busy the Task Force is, the resources they have and the extent of that research plan.

它根據工作組的繁忙程度、他們擁有的資源以及研究計劃的範圍而有所不同。

So what you would expect next is to see the research plan.

所以你接下來期望的是看到研究計劃。

We were kind of expecting that to be in the first quarter of this year.

我們預計這會在今年第一季發生。

It looks like it's going to be a little bit later.

看來要晚一點了。

So the whole process gets shifted and it will be approximately 2.5 to 3 years from the time that research plan gets initiated or published until the final guidance.

因此，整個過程發生了變化，從研究計劃啟動或發佈到最終指導意見大約需要 2.5 到 3 年的時間。

So it's looking more like 2027 based upon that timeline.

因此，根據該時間表，看起來更像是 2027 年。

We've obviously been through two of these cycles, so we're awfully familiar with it.

顯然我們已經經歷過其中兩個週期，所以我們非常熟悉它。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

I want to talk about two things.

我想談兩件事。

Cologuard Momentum and then I want to take another angle on Cologuard Blood.

Cologuard Momentum，然後我想從另一個角度來看 Cologuard Blood。

So on Cologuard Momentum.

Cologuard Momentum 也是如此。

It seems like first time orders grew double digits sequentially, assuming I'm doing the math right.

假設我計算正確的話，似乎第一次訂單連續成長了兩位數。

That's impressive.

這令人印象深刻。

I'm just wondering how much of that seasonality versus new hires and maybe some of it is streamlining of commercial leadership.

我只是想知道與新員工相比，季節性因素有多少，也許其中一些是為了精簡商業領導。

So that's the first topic.

這就是第一個主題。

The second topic is on Cologuard Plus.

第二個主題是 Cologuard Plus。

You've talked about the clear cost advantages of using PCR versus sequencing.

您談到了使用 PCR 與定序相比的明顯成本優勢。

What's unclear is if there are structural disadvantages from a performance standpoint either because of things like limitations in terms of number of markers or CPG islands, you can query a detail or GC bias, just to name a couple of things.

目前尚不清楚的是，從效能角度來看是否存在結構性缺點，無論是由於標記數量限制還是 CPG 島，您可以查詢細節或 GC 偏差，僅舉幾例。

Last quarter, you talked about processing 3,000 samples, and I bring that up because you said specifically you were doing that to collect more data on specificity.

上個季度，您談到了處理 3,000 個樣本，我之所以提出這一點是因為您明確表示這樣做是為了收集更多有關特異性的數據。

I just want to give you an opportunity to address the question of NGS versus PCR trade-offs.

我只是想給您一個機會來解決 NGS 與 PCR 權衡的問題。

Specifically, are there any structural disadvantages such as lower specificity?

具體來說，是否存在特異性較低等結構上的缺點？

And then related to that, Kevin, there's a long history of attenuation in this industry when companies lock down their assays and actually run them for the first time on samples in a large, randomized, prospectively collective -- collected sample study.

與此相關的是，凱文，當公司鎖定他們的檢測方法並在大型、隨機、前瞻性集體收集樣本研究中首次對樣本進行實際運行時，這個行業有很長的衰減歷史。

You saw this with Cologuard, we saw it with

您透過 Cologuard 看到了這一點，我們透過

[Guardant].

[守衛]。

We've seen it almost every time.

我們幾乎每次都見過它。

Why is this not a concern?

為什麼這不是一個問題？

Doug, can you answer you -- there was a piece that I missed after the structural differences between PCR and next-generation sequencing.

道格，你能回答你嗎——在 PCR 和下一代定序之間的結構差異之後，我漏掉了一段內容。

And I missed that part of your question.

我錯過了你問題的那一部分。

It's really the attenuation, Kevin.

這確實是衰減，凱文。

As you know, and you and I have talked about a bunch of times over the years, attenuation occurs almost every time you take a an assay lock it down and run it on prospectively randomized collected samples.

如您所知，多年來您和我已經討論過很多次，幾乎每次您進行檢測鎖定並在前瞻性隨機收集的樣本上運行時都會發生衰減。

Why is that not a concern here?

為什麼這不是一個問題？

It's interesting.

這很有趣。

In the last study we did, there wasn't an attenuation.

在我們上次的研究中，沒有出現衰減。

And the reason was we have gotten a lot better at algorithm-setting studies.

原因是我們在演算法設定研究方面取得了很大進展。

The more samples that you study and especially normals -- actually, I shouldn't be given away inside knowledge here.

你研究的樣本越多，尤其是正常樣本——實際上，我不應該在這裡洩漏內部知識。

So what I will say is we have gotten better at setting the algorithm and by getting better in the study, the algorithm setting study -- from the algorithm setting study for Cologuard Plus to the final readout we saw performance improvement, which was very different than the algorithm setting study for the original Cologuard to the release of the DeeP-C data.

所以我要說的是，我們在設定演算法方面取得了更好的成績，並且透過在研究中取得更好的成績，演算法設定研究——從Cologuard Plus 的演算法設定研究到最終讀數，我們看到了效能改進，這與從原始Cologuard的演算法設定研究到DeeP-C數據的發布。

Why?

為什麼？

We have gotten better at doing those studies.

我們在這些研究方面做得更好了。

And I just -- the team is world-class.

我只是──這個團隊是世界一流的。

So there are pros and cons of PCR versus sequencing.

因此，PCR 與定序相比各有利弊。

I would say that remember, we used sequencing to discover the markers that we use in both Cologuard Plus and also our blood-based colon cancer screening test.

我想說的是，請記住，我們使用定序來發現我們在 Cologuard Plus 和基於血液的結腸癌篩檢測試中使用的標記物。

And think of it this way, the fewer markers you use, there's less noise.

這樣想，你使用的標記越少，噪音就越少。

The more markers use, there can be more noise.

使用的標記越多，噪音就會越大。

Now that's not a rule because there's also noise generated from PCR, there's noise generated from sequencing.

現在這不是一個規則，因為 PCR 也會產生噪音，而定序也會產生噪音。

And so these things tend to balance themselves out with the Exact Sciences R&D team is world-class at figuring out a way to make that trade-off between sensitivity and specificity, I think we're the only ones who have figured out how to do it with PCR.

因此，這些事情往往會與 Exact Sciences 研發團隊取得平衡，他們在找到一種方法來在靈敏度和特異性之間進行權衡方面是世界一流的，我認為我們是唯一知道如何做到這一點的人與PCR。

And it's a huge advantage.

這是一個巨大的優勢。

People often say, well, yes, but you're not using next-generation sequencing.

人們常說，嗯，是的，但你沒有使用下一代定序。

It's not state-of-the-art.

這不是最先進的。

It's actually the opposite is true.

事實上恰恰相反。

It's scientifically harder to do what we have done, which is to focus on cost of goods and performance and to deliver on both.

從科學角度來看，我們所做的事情（即專注於商品成本和性能並同時實現兩者）更加困難。

And -- so the data is going to show the results, right?

而且——所以數據會顯示結果，對嗎？

And so in the fourth quarter, we'll know.

所以在第四季度，我們就會知道。

Again, we don't know what the results are.

同樣，我們不知道結果是什麼。

It's science.

這是科學。

Anything can happen.

任何事情都可能發生。

I'm not -- we're confident, but we don't have a crystal ball as to what will result.

我不是——我們有信心，但我們沒有水晶球來預測結果。

But the beautiful part of our advanced proprietary PCR platform, coupled with our deep knowledge of DNA methylation biomarkers and the regions within the best biomarkers is a unit cost advantage.

但我們先進的專有 PCR 平台的美妙之處，加上我們對 DNA 甲基化生物標記和最佳生物標記內區域的深入了解，是單位成本優勢。

So that if we deliver comparable data with our platform, with our cost advantage, we can deliver an appropriately priced test to patients who may benefit and then with our system and data and knowledge and relationships with payers and providers, we can actually get a blood test to the right people.

因此，如果我們透過我們的平台提供可比較的數據，憑藉我們的成本優勢，我們可以為可能受益的患者提供價格適當的測試，然後利用我們的系統、數據、知識以及與付款人和提供者的關係，我們實際上可以得到血液檢查給合適的人。

And so that's why we think we win.

這就是為什麼我們認為我們贏了。

This will obviously take time.

這顯然需要時間。

I would bet on the Exact Sciences team.

我押注精確科學團隊。

And Doug, then just on the Cologuard Momentum.

道格 (Doug) 則是剛參加了 Cologuard Momentum。

Yes, 15% growth for screening in the quarter.

是的，本季篩檢量增加了 15%。

We saw growth actually across all three segments, so rescreen, 45% to 49% and 50% plus.

我們實際上看到了所有三個細分市場的成長，因此重新篩選，成長了 45% 至 49% 以及 50% 以上。

We highlighted rescreens last year were roughly 20% and of total revenue, and we're on track to grow that by at least a couple of percentage points this year.

我們強調去年重映約佔總營收的 20%，今年我們可望將這一比例成長至少幾個百分點。

I'd also just call out in the 45% to 49%.

我也只是在 45% 到 49% 之間喊話。

Solid growth from that.

由此而來的穩健成長。

This remains one of our leading growth opportunities.

這仍然是我們主要的成長機會之一。

Recall, there's still 19 million Americans in this cohort, and there's less than 20% of those that have been screened.

回想一下，這個群體中仍有 1,900 萬美國人，其中只有不到 20% 接受過篩檢。

If we're able to keep them screened for 30-plus years, this is an even bigger recurring revenue opportunity for us.

如果我們能夠對它們進行 30 多年的篩選，這對我們來說是一個更大的經常性收入機會。

And we're really excited about all the new ways that we can reach this patient population.

我們對能夠接觸到這些患者群體的所有新方法感到非常興奮。

They don't see their primary care provider as often as some of the other age groups.

他們不像其他年齡層的人那樣經常去看初級保健提供者。

And so we're leveraging digital, our social marketing, unique ways to target them as well as part of our care gap programs.

因此，我們正在利用數位化、社交行銷、針對他們的獨特方式以及我們的護理差距計劃的一部分。

And we've seen a nice uptick in 45 to 49 coming through the care gap programs as well.

我們也看到，通過護理缺口計畫的人數也大幅增加，從 45 人增加到 49 人。

Vijay Kumar, Evercore ISI.

維傑·庫馬爾，Evercore ISI。

Congrats on good Kevin, I had a two parter.

恭喜凱文，我有一個兩個夥伴。

One on OpEx here, down sequentially 7%.

其中一項是營運支出，季減 7%。

And were there any one-offs in the quarter from a timing perspective?

從時間角度來看，本季是否有任何一次性事件？

And should OpEx be consistent at current levels?

營運支出是否應該保持在當前水準？

Or how should we think about OpEx ramp in the back half?

或者我們應該如何考慮下半年的營運支出成長？

And the second parter was -- how are you thinking about -- you mentioned the price advantage on your blood-based test.

第二個人是——你怎麼想——你提到了以血液為基礎的檢驗的價格優勢。

I'm curious how are payers going to look at -- if there are two blood-based tests at different price points, how do you think payers sort of react to different tests?

我很好奇付款人會如何看待——如果有兩種不同價位的血液測試，你認為付款人對不同的測試有何反應？

Vijay, I'll take this there, and I'll take the first part of the question just as it relates to OpEx.

Vijay，我將回答這個問題，我將回答與營運支出相關的問題的第一部分。

So no specific one-timers, especially we broke out gap versus adjusted OpEx.

因此，沒有具體的一次性指標，尤其是我們與調整後的營運支出之間出現了差距。

And so on an adjusted OpEx basis, obviously, all the one-timers would be excluded on a GAAP basis, there was one item that sat within the G&A line.

因此，在調整後的營運支出基礎上，顯然，所有一次性項目都將根據 GAAP 原則排除在外，其中有一個項目位於 G&A 行內。

But on an adjusted basis, you can expect kind of consistency on the G&A line, Q2 into the back half of the year.

但在調整後的基礎上，您可以預期第二季到今年下半年的一般管理費用線會保持一定的一致性。

I would expect a sequential step-up implied in both sales and marketing as well as in R&D.

我預期銷售、行銷以及研發方面都會出現連續性的提升。

As we move into the back half of the year, R&D largely tied to our MRD program?

當我們進入下半年時，研發很大程度上與我們的 MRD 計畫相關嗎？

And then marketing just typically tied to higher viewership in the back half of the year.

然後行銷通常與下半年更高的收視率掛鉤。

And in terms of how the payers are going to look at a lower price test, I think that the way that payers tend to look at any type of service is they are adept at finding a way to deliver best performance at the best cost to the plan.

就付款人如何看待較低價格測試而言，我認為付款人傾向於看待任何類型的服務，他們善於找到一種方法，以最佳成本向客戶提供最佳性能。

And that means they have a range of tools from prior authorization to step edits to -- tools that allow them to make sure that the right test is performed.

這意味著他們擁有一系列工具，從事先授權到步驟編輯，再到確保執行正確測試的工具。

One key opinion leader yesterday said, she was excited and this is public, (inaudible) and she said, look, I'm excited about the blood test FDA approval.

一位關鍵意見領袖昨天表示，她很興奮，而且這是公開的（聽不清楚），她說，看，我對 FDA 批准血液測試感到興奮。

There is a highly resistant population that will always refuse colonoscopy and stool tests it gives them another option.

有一個高度抵抗力的人群總是拒絕大腸鏡檢查和糞便測試，這給了他們另一個選擇。

But here's the important part.

但這是重要的部分。

But I hope to God that everyone understands that these are not the same thing.

但我希望上帝讓每個人都明白，這不是一回事。

And I think payers understand that a test that is not part of the quality measures, a test whose performance is not as good in terms of light years gained as a FIT test.

我認為付款人明白，這項測試不屬於品質衡量標準，就獲得的光年數而言，該測試的性能不如 FIT 測試。

There's going to be an appropriate role that is going to be determined likely by USPSTF payers and then health systems and primary care physicians, and that's going to be a long road.

USPSTF 付款人可能會確定一個適當的角色，然後由衛生系統和初級保健醫生確定，這將是一條漫長的道路。

Dan Brennan, TD Cowen.

丹布倫南，TD·考恩。

Maybe first one, I know there's been a few questions on care gap.

也許第一個，我知道有一些關於護理差距的問題。

Could you just potentially quantify how big care gap is in the second half since there's a lot of consternation about the expected Cologuard ramp second half, first half?

由於人們對預計的 Cologuard 下半年和上半年的成長感到非常震驚，您能否量化下半年的照護差距有多大？

And is there any sales force expansion baked in the second half?

下半年是否會擴大銷售團隊？

And then Kevin, on blood.

然後是凱文，關於血。

I know previously you talked about getting the data in October.

我知道您之前談過獲取 10 月份的數據。

Now it seems like we'll get the case-control data at some point and then the pivotal data after that.

現在看來我們將在某個時刻獲得病例對照數據，然後再獲得關鍵數據。

Can you just speak to kind of maybe when we might see the case-control data?

您能談談我們什麼時候可以看到病例對照數據嗎？

And then finally, on Cologuard Plus and the clinical fee schedule.

最後，關於 Cologuard Plus 和臨床費用表。

Can you just discuss the rationale for the 1.25x crosswalk?

您能否討論一下 1.25 倍人行橫道的基本原理？

Is that just based upon cost of goods sold or maybe lab costs?

這只是基於銷售商品的成本還是實驗室成本？

Any color on that?

那上面有什麼顏色嗎？

Yes, Dan.

是的，丹。

So I'll take the care gap piece first.

所以我先拿護理間隙片。

So we haven't sized it other than just to say again that we did more in the first half of this year than all of 2023, we're excited about what care gap is and new ways to help close the screening gap.

因此，我們沒有調整規模，只是再次強調，我們今年上半年所做的工作比 2023 年全年還要多，我們對護理差距是什麼以及幫助縮小篩檢差距的新方法感到興奮。

And just based on looking at our pipeline and what we saw cloud in Q2, we know there will be a sequential step up Q2 to Q3, Q3 to Q4.

僅根據我們的管道以及我們在第二季度看到的雲，我們就知道第二季到第三季、第三季到第四季將會連續上升。

With respect to the sales force expansion, so there's not an embedded like increased costs baked into that.

關於銷售團隊的擴張，因此並沒有像增加成本那樣嵌入其中。

We brought the reps on in May, and so we'll see a little bit just a full quarter impact of that in Q3 and Q4 and then the total impact from sales and marketing investments from a revenue perspective, we would expect to see some impact, and that would be more 4Q weighted.

我們在五月聘請了代表，因此我們將看到第三季和第四季的整個季度影響，然後從收入角度來看銷售和行銷投資的整體影響，我們預計會看到一些影響，這將是更多的4Q 加權。

It typically takes the average rep about 6 months to get up to productivity?

銷售代表平均需要約 6 個月才能達到生產力水準？

Dan, in terms of the release of the prospective algorithm setting study and that data, we're looking for the best conference to share that data at.

Dan，就前瞻性演算法設定研究和數據的發布而言，我們正在尋找最好的會議來分享這些數據。

We do not want to do it on an earnings call.

我們不想在財報電話會議上這樣做。

So we're looking sometime in the fall to present that data in advance of the pivotal study data.

因此，我們希望在秋季的某個時候在關鍵研究數據之前提供這些數據。

In terms of the question about the 1.25x price, again, there is this -- the process for getting a price from Medicare is relatively complex we're not going to go into the details of that process.

關於 1.25 倍價格的問題，同樣，從 Medicare 獲取價格的過程相對複雜，我們不打算詳細介紹這個過程。

That is going to take some time to play out, and we have multiple different options there.

這需要一些時間才能實現，我們有多種不同的選擇。

So we're just not going to get into all of those details.

所以我們不會討論所有這些細節。

And other than to say, an increase in price is predicated on an increase of value that is delivered to the people who are going to get this test into the health care system and overall costs.

除此之外，價格的上漲取決於向醫療保健系統中接受這項測試的人們提供的價值和整體成本的增加。

Jack Meehan, Nephron Research.

傑克·米漢，腎單位研究。

So I wanted to ask about what your expectation is around marketing and screening when Shield comes to market.

所以我想問一下，當 Shield 上市時，您對行銷和篩選有何期望。

So in fairness to Garden, they got a primary screening label from the FDA that was better than I was expecting.

因此，公平地說，Garden 獲得了 FDA 的初步篩選標籤，這比我的預期要好。

There's obviously some precautionary language in there.

裡面顯然有一些預防性的語言。

So I was just curious what your plan is to counter detail?

所以我只是好奇你的反細節計畫是什麼？

And how do you see that playing out with PCPs.

您如何看待 PCP 的這種情況？

We've built deep relationships with healthcare providers.

我們與醫療保健提供者建立了深厚的關係。

Over 300,000 have ordered Cologuard with health systems, virtually every health system in the US utilizes Cologuard on a regular basis to drive increase in screening as we mentioned, according to CDC, the main reason for over a 10 percentage point increase in colon cancer screening is Cologuard.

超過30 萬人已在醫療系統中訂購了Cologuard，幾乎美國的每個醫療系統都定期使用Cologuard 來推動篩檢的增加，正如我們提到的，根據CDC 的數據，結腸癌篩檢增加超過10 個百分點的主要原因是色彩衛士。

These are deep relationships we have a -- we think, the best commercial team, sales and marketing team in the country.

我們認為，這些都是深厚的關係，我們擁有全國最好的商業團隊、銷售和行銷團隊。

A part of that leadership team is here in the offices today.

該領導團隊的一部分今天在辦公室。

It's an amazing group the Exact Nexus platform making electronic ordering easy, the ability to work with payers and large health systems to meet the patient where they want to be screened in the privacy of their own home.

這是一個了不起的團隊，Exact Nexus 平台使電子訂購變得容易，能夠與付款人和大型醫療系統合作，滿足患者在自己家中私密地進行篩檢的需求。

It's really a rich and deep infrastructure that we've built.

這確實是我們建造的豐富而深入的基礎設施。

And that is -- we look -- we actually look forward to competition.

那就是——我們看起來——我們實際上期待競爭。

I really believe that competition makes people better.

我堅信競爭可以讓人變得更好。

It makes them better individually.

這使他們個人變得更好。

It makes them -- makes you better as a team.

它讓他們——讓你作為一個團隊變得更好。

It makes you sharper, it makes you hungrier.

它讓你更加敏銳，讓你更飢餓。

And here, we start from the point that the data, the difference between Cologuard Plus -- the difference between Cologuard and any of the blood data is night and day.

在這裡，我們從數據開始，Cologuard Plus 之間的差異——Cologuard 與任何血液數據之間的差異是白天和黑夜。

And so there's a passion behind what we do, getting the best test to the people who need to get screened.

因此，我們的工作充滿熱情，為需要篩檢的人提供最好的檢測。

And I think we're going to compete.

我認為我們將會競爭。

And I happen to think that the competition is going to make us better.

我碰巧認為競爭會讓我們變得更好。

It's going to actually drive growth.

這將真正推動成長。

There's -- it's -- we're a trusted source of information to providers, and they're going to ask us, and we are going to strive to be truthful and accurate and we're able to do that because of the data.

我們是提供者值得信賴的資訊來源，他們會詢問我們，我們將努力做到真實和準確，並且由於數據，我們能夠做到這一點。

Michael Ryskin, Bank of America.

麥可‧萊斯金，美國銀行。

Just one quick one for me in the interest of time.

為了節省時間，我只會快速寫一篇。

Following up on an earlier point. you said a number of times, Kevin, is that -- when it comes to CG Plus, do you think it's going to be comparable or at least comparable to other blood tests.

繼續之前的觀點。 Kevin，你已經說過很多次了，當談到 CG Plus 時，你認為它會與其他血液檢查具有可比性或至少具有可比性嗎？

Just what do you mean by comparable?

你所說的可比較是什麼意思？

Are you talking about sensitivity, specificity?

你說的是敏感度還是特異性？

Are you -- what specific metrics are you talking about AA or Stage 1?

您在談論 AA 或第一階段的特定指標是什麼？

Just sort of how do we assess that?

我們如何評估這一點？

Because there are a number of different ways you can open these tests, obviously.

顯然，因為您可以透過多種不同的方式開啟這些測試。

Yes, sure.

是的，當然。

So the specificity that we are targeting is at 90%, which is the Medicare minimum to get paid.

因此，我們的目標是 90%，這是 Medicare 獲得付款的最低標準。

Medicare minimum for sensitivity is 74%.

醫療保險的最低敏感度為 74%。

What we have seen from others is in the 80% to -- very low 80% sensitivity.

我們從其他人那裡看到的是 80% 到非常低的 80% 敏感度。

And what we have seen from others is in the 11% to 13%, I think, precancer detection.

我們從其他人那裡看到的是 11% 到 13%，我認為是癌前檢測。

Now remember, that precancer detection you get 10 points of precancer detection just because of the 10% false positivity.

現在請記住，癌症前期檢測僅因為 10% 的假陽性率而獲得 10 分。

So with tests in the blood liquid biopsy test for colon cancer screening, they're essentially blind to precancerous polyps above the -- above the false positive rate.

因此，透過結腸癌篩檢的血液液體活檢測試，他們基本上對高於假陽性率的癌前息肉視而不見。

That's -- you have to take that into account.

那是——你必須考慮到這一點。

What we're seeing is similar -- very similar cancer detection, better precancer detection.

我們看到的是相似的——非常相似的癌症檢測，更好的癌前檢測。

And again, we don't know how that is going to play out in the BLUE-C study, but we have a scientific team that has done an amazing job of -- I think altogether, we've done seven, eight or nine case control studies leading up to where we are now heading into the pivotal.

再說一遍，我們不知道 BLUE-C 研究將如何發揮作用，但我們有一個科學團隊，他們做了出色的工作——我認為總共我們已經做了七、八或九項病例對照研究導致我們現在進入關鍵階段。

So this wasn't just a couple of case control studies.

所以這不僅僅是幾個病例對照研究。

This is rigorous science.

這是嚴謹的科學。

We -- but that's how we're looking at it.

我們——但這就是我們的看法。

The 90% specificity minimum.

特異性最低為 90%。

We're shooting for in that low 80% range, but the key is Medicare minimum is 74% in the precancer.

我們的目標是在 80% 的低範圍內，但關鍵是 Medicare 最低限額是癌前患者的 74%。

Now remember, this nets out in terms of modeling of life years gained, and the greater the precancer sensitivity detection, the more life years gain you get.

現在請記住，這是根據所獲得的生命年的建模得出的，癌前敏感性檢測越大，獲得的生命年就越多。

So probably a key indicator would be a comparison of life years gained.

因此，一個關鍵指標可能是對所獲得的壽命進行比較。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Kevin, just following up on that question, another question that we've been getting is do you think FDA would be open to approving an assay, if it is slightly lower or maybe a bit more lower than the current performing -- current test that's in the market that was just recently approved.

凱文，就這個問題進行跟進，我們收到的另一個問題是，您認為 FDA 是否會願意批准一項檢測，如果它比當前的測試稍低或可能更低一點——當前的測試在最近剛剛獲得批准的市場上。

And then a broader question on Cologuard Plus, could you refresh us on your thinking about the type of -- or the extent of pickup that you would see from the primary care physicians when Cologuard Plus does launch into the market next year?

然後是關於 Cologuard Plus 的一個更廣泛的問題，您能否向我們介紹一下您對明年 Cologuard Plus 進入市場時您將從初級保健醫生那裡看到的類型或範圍的看法？

Repeat the first question.

重複第一個問題。

Yes.

是的。

The first question is simply that would -- in your thinking, would FDA be willing to approve a test if it is lower than the competitor blood-based test that was recently just approved in terms of performance and by that, I mean sensitivity and/or specificity.

第一個問題很簡單，在您看來，如果一項測試的性能低於最近剛剛批准的競爭對手基於血液的測試，那麼 FDA 是否願意批准一項測試，我的意思是敏感性和/或特異性性。

So when you run a study, you run that study based upon endpoints that are set in the study and our end points have already been established.

因此，當您進行研究時，您會根據研究中設定的終點來運行研究，並且我們的終點已經確定。

So we are confident that the any test, not just ours that achieves the -- certainly, the Medicare minimum of 74% is likely to get FDA approval from a precancer detection standpoint, I think that's probably less likely given the limited label that the blood tests are seeking.

因此，我們相信，從癌前檢測的角度來看，任何達到醫療保險最低74% 的測試（而不僅僅是我們的測試）都可能獲得FDA 的批准，我認為考慮到血液標籤有限，這種可能性可能較小。

In terms of Cologuard Plus adoption over -- after launch, two out of three docs, they will order more frequently because of the lower false positive rate.

就 Cologuard Plus 的採用率而言，在推出後，三分之二的醫生會更頻繁地訂購，因為誤報率較低。

One of the -- we've said this in the past, one of the challenges with Cologuard was a 10% false positive rate.

其中之一——我們過去曾說過，Cologuard 面臨的挑戰之一是 10% 的誤報率。

That false positive rate Is now 7% with Cologuard Plus.

使用 Cologuard Plus 後，誤報率現在為 7%。

And that is very important because when you look at it at a population level, if you screen let's say, 1 million people, you're talking about tens of thousands of fewer people going to colonoscopy because Cologuard Plus is available.

這非常重要，因為當你從人口層面來看時，如果你對 100 萬人進行篩檢，那麼由於 Cologuard Plus 的推出，接受大腸鏡檢查的人數就會減少數萬人。

And again, that goes back to the science.

再說一次，這又回到了科學。

The science that lowered the false positive rate.

降低誤報率的科學。

Fewer markers, lower false positive rate, same essential PCR platform that we're using in CRC blood.

更少的標記，更低的假陽性率，與我們在 CRC 血液中使用的相同的基本 PCR 平台。

Subu Nambi, Guggenheim.

蘇布南比，古根漢。

Two questions.

兩個問題。

What is the TGen discontinuation mean for MRD?

TGen 停藥對 MRD 意味著什麼？

And second, regarding Oncotype and MRD, it seems like there could be an opportunity and also a threat.

其次，關於 Oncotype 和 MRD，似乎既有機會，也有威脅。

On one hand with Oncotype, you have the tumor tissue, which would seemingly give you an advantage in that you can create a bespoke assay.

一方面，使用 Oncotype，您可以獲得腫瘤組織，這似乎會給您帶來優勢，因為您可以創建自訂檢測。

But on the other hand, bespoke MRD assays could conceivably cannibalize Oncotype or even lead to some share loss.

但另一方面，客製化的 MRD 檢測可能會蠶食 Oncotype，甚至導致一些份額損失。

Am I thinking about this the right way?

我以正確的方式思考這個問題嗎？

Or can you share your thoughts on opportunity versus risk?

或者可以分享一下您對機會與風險的看法嗎？

Yes.

是的。

So in terms of the TGen question, no, we attempt to develop an MRD test with that technology.

因此，就 TGen 問題而言，不，我們嘗試使用該技術開發 MRD 測試。

And then we opted for our own internally developed technology, coupled with technology that we licensed from the Broad.

然後我們選擇了我們自己內部開發的技術，加上我們從 Broad 獲得許可的技術。

And then in terms of the advantage that we have because of our Oncotype DX is we see an enormous percentage of all US breast cancer tissue samples and having that tissue sample as a starting point for breast MRD is a huge advantage.

然後，就我們 Oncotype DX 帶來的優勢而言，我們看到了美國所有乳癌組織樣本中的很大一部分，並且將該組織樣本作為乳腺 MRD 的起點是一個巨大的優勢。

It's Oncotype DX has about 90% share.

它的Oncotype DX擁有大約90%的份額。

And as a result, we have a deep relationship with almost every health system in the US, and we think that is going to convert a real advantage for us over time.

因此，我們與美國幾乎每個衛生系統都建立了深厚的關係，我們認為隨著時間的推移，這將為我們帶來真正的優勢。

So these tests are really complementary.

所以這些測試確實是互補的。

The Oncotype DX test and the MRD test OncoDetect that we're developing.

我們正在開發 Oncotype DX 測試和 MRD 測試 OncoDetect。

We're looking forward to sharing the OncoDetect data later this year, and we look forward to our next earnings call and having future conversations with you all in between.

我們期待在今年稍後分享 OncoDetect 數據，也期待我們的下一次財報電話會議以及在此期間與大家進行未來的對話。

Thank you all.

謝謝大家。

And just one more shout out to the Exact Sciences team so dedicated to the mission, so dedicated to delivering on our goals for the year.

再次向 Exact Sciences 團隊致敬，他們如此致力於這項使命，如此致力於實現我們今年的目標。

Thank you very much.

非常感謝。

And ladies and gentlemen, that concludes today's call.

女士們、先生們，今天的電話會議到此結束。

Thank you all for joining, and you may now disconnect.

感謝大家的加入，現在可以斷開連線了。