Veracyte Inc (VCYT) 2024 Q3 法說會逐字稿

Good day. And thank you for standing by. Welcome to the Veracyte third quarter, 2024 conference call. At this time. All participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session to ask a question during the session. You will need to press star one on your telephone and you will hear an automated message advising you your hand is raised to withdraw your question. Please press star one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Shayla Gorman, Senior Director of Investor Relations, Shayla, you have the floor.

再會。感謝您的支持。歡迎參加 Veracyte 2024 年第三季電話會議。此時。所有參與者都處於只聽模式。演講者演講結束後，將進行問答環節，在會議期間提出問題。您需要按電話上的星號一，您將聽到一條自動訊息，建議您舉手撤回問題。請再按星號一。請注意，今天的會議正在錄製中。現在我想將會議交給今天的第一位發言人 Shayla Gorman，投資者關係高級總監 Shayla，請發言。

Good afternoon everyone. And thank you for joining us today for a discussion of our third quarter 2024. Financial results with me today are Marc Stapley. Veracyte's Chief Executive Officer and Rebecca Chambers. Our Chief Financial Officer Veracyte issued a press release earlier this afternoon detailing our third quarter 2024 financial results. This release and a business and financial presentation are available in the investor relations section of our website at Veracyte.com.

大家下午好。感謝您今天加入我們討論 2024 年第三季。今天和我一起討論財務表現的是馬克‧斯塔普利 (Marc Stapley)。Veracyte 執行長和麗貝卡·錢伯斯。我們的財務長 Veracyte 今天下午早些時候發布了一份新聞稿，詳細介紹了我們 2024 年第三季的財務業績。本新聞稿以及業務和財務簡報可在我們網站 Veracyte.com 的投資者關係部分取得。

Before we begin, I'd like to remind you that various statements we make during this call will include forward-looking statements as defined under applicable securities laws. Forward-looking statements are subject to risks and uncertainties and the company can give no assurance. They will prove to be correct. Additionally, we are not under any obligation to provide further updates on our business trends or our performance during the quarter to better understand the risks and uncertainties that could cause actual results to differ. We refer you to the documents that Veracyte files with the securities and exchange commission including Veracyte, most recent forms, 10-Q and 10-K.

在我們開始之前，我想提醒您，我們在本次電話會議中所做的各種聲明將包括適用證券法定義的前瞻性聲明。前瞻性陳述存在風險和不確定性，本公司無法提供任何保證。他們將被證明是正確的。此外，我們沒有義務提供有關本季業務趨勢或業績的進一步更新，以便更好地了解可能導致實際結果不同的風險和不確定性。我們請您參閱 Veracyte 向證券交易委員會提交的文件，包括 Veracyte、最新表格、10-Q 和 10-K。

In addition, this call will include certain Non-GAAP financial measures, reconciliation of these measures to the most directly comparable GAAP. Financial measures are included in today's earnings release accessible from the IR section of Veracyte website. I will now turn the call over to Marc Stapley Veracyte, CEO.

此外，本次電話會議將包括某些非公認會計原則財務指標，這些指標將與最直接可比較的公認會計原則進行調整。財務指標包含在今天的收益報告中，可透過 Veracyte 網站的 IR 部分存取。我現在將把電話轉給執行長 Marc Stapley Veracyte。

Thank you, Shayla and thanks everyone for joining us today.

謝謝 Shayla，也謝謝大家今天加入我們。

Q3 marked another record quarter for Veracyte. I couldn't be more proud of our team and of our hard work on behalf of the patients. We serve Q3 revenue totaled $115.9 million growing 29% year over year.

第三季標誌著 Veracyte 另一個創紀錄的季度。我為我們的團隊以及我們為患者所做的辛勤工作感到無比自豪。我們第三季的服務收入總計 1.159 億美元，年增 29%。

This was fueled by testing revenue which grew an incredibly robust 34% compared to the prior year period driven by strong volume and ASP improvements. Both of which continue to outpace our expectations.

這是由測試收入推動的，在銷售強勁和平均售價提高的推動下，測試收入比去年同期增長了 34%。兩者都繼續超出我們的預期。

Q3 represents our ninth consecutive quarter of 25% or greater testing revenue growth demonstrating clearly the durability of our testing portfolio.

第三季是我們連續第九個季度實現 25% 或更高的測試收入成長，這清楚地表明了我們測試組合的耐用性。

Throughout this year, we have shared our confidence that a firmer and Decipher will continue to deliver outsized revenue growth over the next number of years, bridging to our long term strategic growth drivers and the trends. We observed this quarter to reinforce that we are on a solid trajectory.

今年全年，我們都堅信，更堅定的 Decipher 將在未來幾年繼續實現超額收入成長，為我們的長期策略成長動力和趨勢奠定基礎。我們觀察本季的情況是為了強化我們正走在堅實的軌道上。

Starting with Decipher, we delivered a record 21,250 tests during the third quarter, up 36% year over year with growth across all NCCN and localized risk categories.

從 Decipher 開始，我們在第三季交付了創紀錄的 21,250 次測試，年增 36%，所有 NCCN 和在地化風險類別均出現成長。

With the updated NCCN guidelines in place. Our incredibly productive urology sales force consisting of around 50 reps is driving adoption through awareness and education on the test, utility and market leading clinical evidence.

更新後的 NCCN 指南已到位。我們由約 50 名代表組成的高效泌尿科銷售隊伍正在透過對測試、實用性和市場領先臨床證據的認識和教育來推動採用。

Decipher's clinical validity and utility has already been demonstrated in approximately 85 clinical studies. And over 120 additional publications have focused on data from Decipher grid. Our research use only platform in the third quarter alone, there were 14 publications abstracts and presentations utilizing Decipher prostate or data from grid generating clinical evidence for Decipher remains a top priority for us to drive further guideline inclusion, durable reimbursement and increased test differentiation in this under penetrated market.

Decipher 的臨床有效性和實用性已在大約 85 項臨床研究中得到證實。還有超過 120 個出版物關注來自 Decipher grid 的數據。僅在第三季度，我們的研究僅使用平台，就有14 篇出版物摘要和演示文稿利用Decipher 前列腺或來自網格的數據為Decipher 生成臨床證據，這仍然是我們推動進一步納入指南、持久報銷和增加測試差異化的首要任務在滲透市場下。

To that end in early October, new data was presented at Astro 2024 the annual meeting of the American Society for Radiation Oncology from the VANDAAM trial data from this prospective clinical trial showed that the Decipher prostate genomic classifier accurately predicts aggressive prostate cancer among African American men with early stage disease.

為此，10 月初，在美國放射腫瘤學會年會Astro 2024 上公佈了來自VANDAAM 試驗的新數據，該前瞻性臨床試驗的數據表明，Decipher 前列腺基因組分類器可以準確預測非裔美國男性中的侵襲性前列腺癌患有早期疾病。

This population is over 70% more likely to be diagnosed with prostate cancer and more than twice as likely to die of the disease compared to non African American men according to the American Cancer Society.

根據美國癌症協會的數據，與非非裔美國男性相比，這一人群被診斷出患有前列腺癌的可能性高出 70% 以上，死於該疾病的可能性高出兩倍以上。

Despite this few prospective studies have specifically sought to examine the disease at a genomic level in such patients.

儘管如此，少數前瞻性研究還是專門尋求在基因組層級檢查此類患者的疾病。

The VANDAAM findings confirm that use of the genomic test in this population could potentially enable better treatment decisions and outcomes helping to reduce outcome disparities. Something which our industry needs to embrace enrolling diverse patients in our clinical trials is key to this effort and we proactively try and ensure the inclusion of often underrepresented populations, which is something we are passionate about.

VANDAAM 的研究結果證實，在這一人群中使用基因組測試可能會做出更好的治療決策和結果，有助於減少結果差異。我們的行業需要在臨床試驗中招募不同的患者，這是這項工作的關鍵，我們積極嘗試並確保將經常代表性不足的人群納入其中，這是我們熱衷的事情。

We look forward to sharing more on our philosophy and approach in our ESG report which we plan to publish later this year.

我們期待在計劃於今年稍後發布的 ESG 報告中分享更多關於我們的理念和方法。

Another important study was recently presented at the ESMO 2024 Congress in Barcelona where new data from Stampede A phase three randomized Multicenter Multi Arm clinical trial supported by cancer research UK was shared.

最近在巴塞隆納舉行的 ESMO 2024 年大會上公佈了另一項重要研究，其中分享了由英國癌症研究中心支持的 Stampede A 三期隨機多中心多臂臨床試驗的新數據。

This study was focused on the metastatic population, an incident group that has risen by about 5% each year. Since 2014 studies have shown that adding the Chemotherapy dose of Taxol to standard of care, androgen deprivation therapy can improve outcomes for some patients with metastatic prostate cancer.

這項研究的重點是轉移人群，這群人每年增加約 5%。自 2014 年以來的研究表明，在標準護理和雄性激素剝奪療法中添加化療劑量的紫杉醇可以改善一些轉移性前列腺癌患者的預後。

However, the benefit varies from patient to patient and dose attacks or could negatively impact quality of life for many patients.

然而，其益處因患者而異，且劑量攻擊或可能對許多患者的生活品質產生負面影響。

Today, physicians can use tumor volume as a blunt tool to identify who will likely benefit from the drug.

如今，醫生可以使用腫瘤體積作為鈍器來確定誰可能從該藥物中受益。

The Stampede findings demonstrated quite profoundly that decipher may be a more precise tool to distinguish patients who will receive the greatest benefit from dose of Taxol and those who won't.

Stampede 的研究結果深刻地表明，破解可能是一種更精確的工具，可以區分哪些患者將從紫杉醇劑量中獲得最大益處，哪些患者不會從紫杉醇劑量中獲得最大益處。

This could help patients avoid unnecessary toxicity while helping to determine the best treatment path for those who will benefit the most.

這可以幫助患者避免不必要的毒性，同時幫助患者確定最佳治療途徑，使受益最大的患者受益。

This is the first major study highlighting the significant utility of decipher as the only predictive gene expression biomarker for metastatic patients that could positively impact care and quality of life for men living with advanced disease.

這是第一項重大研究，強調了 decipher 作為轉移患者唯一預測基因表現生物標記的重要作用，可以對晚期疾病男性的護理和生活品質產生積極影響。

With the recently finalized LCD covering Decipher's use in the metastatic setting. We believe we have the only prognostic gene expression test able to address the entire prostate market including metastatic patients.

最近完成的 LCD 涵蓋了 Decipher 在轉移性環境中的使用。我們相信，我們擁有唯一能夠滿足整個前列腺市場（包括轉移性患者）的預後基因表現測試。

We are currently underway with the next step of enabling Medicare reimbursement for this additional indication. By following the technical assessment process which we expect will be finalized in late 2024 or early 2025.

我們目前正在進行下一步，為這項額外的適應症提供醫療保險報銷。遵循技術評估流程，我們預計將於 2024 年底或 2025 年初完成。

With sales trading plan for Q1, we are excited about metastatic as a potential growth driver for 2025 and beyond, as we expect to see revenue for this indication start to ramp in the back half of next year.

根據第一季的銷售交易計劃，我們對轉移作為 2025 年及以後的潛在成長動力感到興奮，因為我們預計該適應症的收入將在明年下半年開始成長。

With the expansion of decipher into this broader patient population as well as significant Greenfield opportunity ahead for our test in localized disease. We expect to see continued meaningful growth for the foreseeable future driven by both market penetration and share expansion.

隨著解碼範圍擴大到更廣泛的患者群體，以及我們對局部疾病進行測試的重要機會。我們預計，在可預見的未來，在市場滲透和份額擴張的推動下，將持續有意義的成長。

Moving to a firmer volume growth continues to be impressively strong.

銷售成長持續強勁，令人印象深刻。

During Q3, we delivered close to 15,100 tests up 12% from the prior year period.

第三季度，我們進行了近 15,100 次測試，比去年同期成長了 12%。

Our endocrinology sales force of close to 50 reps has done a tremendous job of driving the durable adoption of a firmer by sharing the differentiated level of evidence for the performance of the test. Alongside the ease of use for physicians. We've made strides in both share and penetration into the long tail of physicians who did not use a molecular diagnostic previously.

我們的內分泌銷售團隊由近 50 名代表組成，透過分享測試表現的差異化證據，在推動公司持久採用方面做出了巨大的努力。除了方便醫生使用之外。我們在以前沒有使用過分子診斷的醫生的長尾份額和滲透方面都取得了長足的進步。

Also this call to the expanded LCD for affirm went into effect, adding reimbursement for Medicare advantage patients with Bethesda thyroid nodules or those that are suspicious for cancer.

此外，擴大 LCD 的呼籲也已生效，增加了對貝塞斯達甲狀腺結節或疑似癌症患者的醫療保險優勢患者的報銷。

This is an immensely helpful outcome for this patient population and further supports our continued leadership in the field.

這對該患者群體來說是一個非常有幫助的結果，並進一步支持我們在該領域的持續領導地位。

While the impact of revenue this quarter was minimal. Given the end of July effective date, we expect this to be a moderate ASP tailwind in 2025 taking into account the momentum we have driven in 2024 as well as the expanded indication. We expect the firmer to continue to demonstrate strong growth of high single digits next year with unwavering demand for decipher and affirm, as well as positively shifting market dynamics. Our confidence in delivering robust revenue growth over the course of the near and midterm has never been stronger and we couldn't be happier with our execution of the first two of our five strategic imperatives, namely to expand Decipher's market size, penetration, leadership position and to deliver continued strong affirm growth.

雖然本季營收的影響微乎其微。鑑於 7 月底的生效日期，考慮到我們在 2024 年推動的勢頭以及擴大的指標，我們預計這將在 2025 年對平均售價產生溫和的推動作用。我們預計，隨著解密和驗證的需求堅定不移，以及市場動態的積極變化，明年該公司將繼續表現出高個位數的強勁成長。我們對在近期和中期實現強勁收入成長的信心從未如此強烈，我們對執行五個戰略要務中的前兩個感到非常高興，即擴大 Decipher 的市場規模、滲透率和領導地位並實現持續強勁的增長。

These will we believe we just through our exciting additional three long term growth drivers. One to launch IVD products for patients globally.

我們相信，我們將透過我們令人興奮的另外三個長期成長驅動力來實現這些目標。其中之一是為全球患者推出 IVD 產品。

Two to serve more of the patient journey through our expansion into minimal residual disease testing or MRD.

兩個是透過我們擴展到微小殘留疾病檢測或 MRD 來服務更多患者的旅程。

And three to solve new cancer challenges, such as with our novel Percepta® Nasal Swab test. for patients identified with a lung nodule critically to balance our investment in innovation. As detailed by these five strategic imperatives, we also regularly assess the prioritization of projects to ensure the appropriate level of investment while also delivering a differentiated financial profile.

其中三個用於解決新的癌症挑戰，例如我們新穎的 Percepta® 鼻拭子測試。對於確定患有肺結節的患者來說，這對於平衡我們在創新方面的投資至關重要。正如這五項策略要務所詳述的那樣，我們還定期評估專案的優先順序，以確保適當的投資水平，同時提供差異化的財務狀況。

As a result of this, we made the difficult decision to pause, offering the envisia a clear test at the end of this year.

因此，我們做出了暫停的艱難決定，在今年年底對設想進行了明確的測試。

While we always aim to put patients first, the low penetration of the test in this uncommon disease category and the life cycle management it would require including continued clinical evidence development. Led us to conclude that we need to focus on our other imperatives for now.

雖然我們始終致力於將患者放在第一位，但這種罕見疾病類別的檢測滲透率較低，並且需要生命週期管理，包括持續的臨床證據開發。使我們得出的結論是，我們現在需要關注其他當務之急。

Turning to those innovative long term growth drivers, I'll share an update on our effort to serve more of the patient journey through MRD and recurrence testing.

談到這些創新的長期成長驅動因素，我將分享我們透過 MRD 和復發檢測為更多患者提供服務的最新努力。

We are progressing well towards our launch of an MRD test in muscle invasive bladder cancer or MIBC in the first half of 2026 including efforts to secure reimbursement through Medicare and readying our laboratory and operational processes.

我們在 2026 年上半年推出針對肌肉浸潤性膀胱癌或 MIBC 的 MRD 檢測方面進展順利，包括努力透過 Medicare 獲得報銷，並為我們的實驗室和營運流程做好準備。

We continue to be very encouraged about the clinical utility of MRD for MIBC using our whole genome approach.

我們繼續對使用我們的全基因組方法進行 MIBC 的 MRD 臨床效用感到非常鼓舞。

A study recently published in European urology showed that a WGS analysis of ctDNA allows for ultrasensitive ctDNA detection in patients with MIBC.

最近發表在歐洲泌尿學雜誌上的一項研究表明，ctDNA 的全基因組定序分析可以對 MIBC 患者進行超靈敏的 ctDNA 檢測。

Importantly, the study demonstrated a mean lead time of over four months between detection of clinical recurrence based on the test compared to radiographic imaging, such critical time savings has the potential to accelerate time to treatment and improve the current clinical management of patients.

重要的是，該研究表明，與放射影像相比，基於測試檢測臨床復發之間的平均提前超過四個月，這種關鍵的時間節省有可能加快治療時間並改善患者目前的臨床管理。

We're excited about the opportunities ahead for MRD, as we have said, while patients with MIBC represent our initial intended use population, given our sales channel and the reimbursement pathway. This is not a single product assay. It is a platform, we plan to expand into other indications and you can assume that would include the ones where we already have a presence in closing Q3 was another exceptional quarter and there is a long runway of opportunity in front of us.

正如我們所說，我們對 MRD 未來的機會感到興奮，而考慮到我們的銷售管道和報銷途徑，MIBC 患者代表了我們最初的預期使用人群。這不是單一產品檢測。這是一個平台，我們計劃擴展到其他適應症，你可以假設這包括我們在第三季末已經存在的適應症，這是另一個特殊的季度，我們面前有很長的機會。

We are primed to continue to deliver robust revenue growth in our core business and we have a number of key catalysts ahead that will expand our care across the patient journey.

我們準備好繼續在核心業務中實現強勁的收入成長，並且我們未來有許多關鍵的催化劑，這些催化劑將擴大我們在整個患者旅程中的照護。

My sincere thanks to the Veracyte team for their relentless focus on our mission to serve patients. It is their hard work that sets us apart as we continue to transform cancer care for patients around the world.

我衷心感謝 Veracyte 團隊對我們服務患者使命的不懈關注。正是他們的辛勤工作使我們在不斷改變世界各地患者的癌症護理方面脫穎而出。

With that, I will now turn to Rebecca to review our financial results for the third quarter and our updated outlook for the remainder of 2024.

接下來，我將請麗貝卡回顧我們第三季的財務表現以及我們對 2024 年剩餘時間的最新展望。

Thanks Marc, Q3 was another excellent quarter with $115.9 million of revenue, an increase of 29% over the prior year period, we grew total volume to approximately 39,000 tests. A 20% increase over the same period in 2023 testing revenue during the quarter was $109.5 million. An increase of 34% year over year driven by decipher and the Afirma revenue growth of 48% and 19% respectively.

感謝 Marc，第三季又是一個出色的季度，營收為 1.159 億美元，比去年同期成長 29%，我們將總測試量增加到約 39,000 次。該季度測試營收為 1.095 億美元，較 2023 年同期成長 20%。得益於 decipher 和 Afirma 營收分別成長 48% 和 19%，較去年同期成長 34%。

Total testing volume was approximately 36,800 tests. Testing ASP was approximately $2975 which included approximately $3.5 million of prior period collections. Adjusting for the impact in the quarter. Testing ASP would have been approximately $2875 up 7% compared to the prior year period.

總測試量約為 36,800 次測試。測試平均售價約為 2975 美元，其中包括約 350 萬美元的前期收款。根據本季的影響進行調整。測試平均售價約為 2,875 美元，比去年同期成長 7%。

As Marc mentioned, we expect to continue to generate strong testing revenue growth in 2025 while absorbing an approximately $6 million headwind. Given our Envisia portfolio planning decision, turning to product third quarter volume was approximately 2,200 tests and revenue was $3.2 million down 21% year over year as we continue to work through supply challenges. Given we are currently managing demand. Our Q4 and 2025 product expectations are muted, BioPharma and other revenue was $3.1 million down 23% year over year.

正如 Marc 所提到的，我們預計 2025 年將繼續實現強勁的測試收入成長，同時吸收約 600 萬美元的阻力。鑑於我們的 Envisia 產品組合規劃決策，第三季產品數量約為 2,200 次測試，營收為 320 萬美元，年減 21%，因為我們繼續應對供應挑戰。鑑於我們目前正在管理需求。我們對第四季和 2025 年的產品預期較低，生物製藥和其他收入為 310 萬美元，年減 23%。

Moving to gross margin and operating expenses. I will highlight our Non-GAAP results.

轉向毛利率和營運費用。我將重點介紹我們的非公認會計準則績效。

Non-GAAP gross margin was 71% up approximately 130 basis points compared to the prior year period. Testing, gross margin was 74% up approximately 10 basis points compared to the prior year period.

非 GAAP 毛利率為 71%，較上年同期成長約 130 個基點。經測試，毛利率為 74%，較去年同期成長約 10 個基點。

Product margin was 44% up from 39% in the prior year period. Biopharmaceutical and other gross margin was 3% down year over year due to lower fixed cost absorption.

產品利潤率為 44%，高於去年同期的 39%。由於固定成本吸收降低，生物製藥和其他毛利率較去年同期下降 3%。

Non-GAAP operating expenses were up 11% year over year at $57.6 million. Research and development expense increased by $3.9 million to 16.1 million. Given personnel additions from our C2I acquisition and increased costs related to our development projects. Sales and marketing expenses declined by $0.8 million to $20.8 million. Given the Envisia sales force reduction performed earlier this year. Partially offset by hiring across affirm and Decipher G&A expenses were up $2.8 million to 20.7 million driven by infrastructure investments and other personnel costs.

非 GAAP 營運費用年增 11% 至 5,760 萬美元。研發費用增加 390 萬美元，達到 1,610 萬美元。鑑於我們的 C2I 收購導致人員增加以及與我們的開發案相關的成本增加。銷售和行銷費用減少 80 萬美元，至 2,080 萬美元。鑑於今年早些時候 Envisia 削減了銷售人員。由於基礎設施投資和其他人員成本的推動，Confirm 和 Decipher 的一般管理費用增加了 280 萬美元，達到 2,070 萬美元，部分抵消了這一影響。

Moving to profitability metrics, we continued to demonstrate strong results. We recorded GAAP net income of $15.2 million and delivered adjusted EBITDA of $27.3 million or 24% of revenue. We generated $38 million of cash in the quarter driven primarily by 30 million of cash from operations and ended Q3 with $274.1 million of cash and cash equivalent.

轉向獲利能力指標，我們持續展現強勁的業績。我們的 GAAP 淨利潤為 1,520 萬美元，調整後 EBITDA 為 2,730 萬美元，佔營收的 24%。我們在本季創造了 3,800 萬美元的現金，主要由營運產生的 3,000 萬美元現金推動，第三季結束時現金和現金等價物為 2.741 億美元。

Looking forward, we are excited to raise our 2024 total revenue guidance to 442 million to $445 million from our prior guidance of $432 million to $438 million. This reflects an improvement in our testing business outlook with revenue growth expectations of approximately 28% as compared to the prior guidance of approximately 25%. And our original guidance entering this year of 13% to 15%.

展望未來，我們很高興將 2024 年總收入指引從先前的 4.32 億美元至 4.38 億美元提高至 4.42 億至 4.45 億美元。這反映出我們的測試業務前景有所改善，收入成長預期約為 28%，而先前的指導約為 25%。我們今年最初的指導是 13% 到 15%。

We are also raising cash guidance and now expect to end 2024 with between $280 million to $285 million in cash equivalents and short-term investments taking into account approximately $10million to $15 million in milestone payments and capital expenditures. Forecasted in the fourth quarter. Additionally, with the profitability, we've achieved year-to-date, we now expect full year 2024 adjusted ebida margin to be slightly more than 20%. This year has been nothing short of fantastic across our financial metrics. We have delivered incredibly strong testing revenue growth, profitability and cash generation. I look forward to carrying this momentum into 2025 as we work towards our vision of helping cancer patients globally. We'll now turn to the Q&A portion of the call.

我們也提高了現金指導，目前預計到 2024 年底，現金等價物和短期投資將達到 2.8 億至 2.85 億美元，其中里程碑付款和資本支出約為 1,000 萬至 1,500 萬美元。預計第四季。此外，考慮到今年迄今我們已經實現的獲利能力，我們現在預計 2024 年全年調整後的 ebida 利潤率將略高於 20%。今年我們的財務指標非常優秀。我們已經實現了令人難以置信的強勁測試收入成長、獲利能力和現金產生。我期待著將這一勢頭延續到 2025 年，我們將努力實現幫助全球癌症患者的願景。我們現在將轉向電話會議的問答部分。

Thank you. At this time, we will conduct the question and answer session as a reminder to ask a question, you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

謝謝。此時，我們將進行問答環節，作為提醒提問，您需要在手機上按星一併等待宣布您的名字才能撤回您的問題。請再按星號一。

Please stand by while I compile the Q&A roster.

我正在整理問答名單，請稍候。

Our first question comes from Subbu Nambi with Guggenheim Securities subu, go ahead with your question.

我們的第一個問題來自古根漢證券公司的 Subbu Nambi，請繼續提問。

Hey guys. Thank you for taking my question. First, the high level question you join Marc, you joined their site as CEO three years ago. It had been a tough period for the group. During this period. You have transformed the leadership team and together with that team, you have succeeded in being emblematic of the diagnostics 2.0 error, driving revenue growth with solid science, moving towards FC and margin expansion as you think about 2025 and beyond. What comes next is it more of the same, which of course would be good or are there other legs to the tool that remains to be unveiled? And then I have a follow up?

嘿夥計們。感謝您回答我的問題。首先，你加入馬克的高級問題，你三年前作為執行長加入了他們的網站。對該團隊來說，這是一段艱難的時期。在此期間。你們已經改變了領導團隊，並與該團隊一起成功地成為診斷 2.0 錯誤的象徵，用紮實的科學推動收入增長，朝著 2025 年及以後的 FC 和利潤擴張邁進。接下來會發生什麼，它會變得更加相同，這當然會很好，還是該工具還有其他有待揭曉的方面？然後我有後續行動嗎？

Great thanks, We appreciate the question and your summary of the last three years, you know we started with obviously a strong foundation. We put three companies together, we did a lot of portfolio analysis and restructuring during that time and have continued to do so as you saw us announce in the current quarter. And as you quite rightly mentioned, you know we rebuilt the leadership team and the you know many of the layers below that, although we still have a lot of the legacy teams of the multiple companies. And so we've really you know focused a lot on talent and scaling. You know in that time we've scaled for example, our Decipher lab to be able to handle three times as many if not more volume, which has been necessary and we haven't missed a beat in terms of turnaround time and things like that. So, you know I credit our team for that. we've brought on exceptional leaders who know what they're doing to add to the talent that we already had. We also knew what they were doing and we've come a long way since and you know I'm pretty proud of the revenue, continued revenue growth, the our ability to deliver on you know our own expectations and the expectations we set. And then really importantly our opportunity to you know, deliver a financial profile with the adjusted EBITDA that we we've been talking about and that we shared on our call today. So, that's all very good as I look for and that's all looking backwards as I look forward into 2025 and beyond, it is a lot of the same and we stay very much focused on the portfolio of products that are successfully generating the revenue growth and profitability that we're driving today. We'll continue to invest in those three important strategic initiatives that we talk about that, you know, deliver long term growth in the future. We acquired a company during that three year time frame C2I and that forms one of those you know, major initiatives, MRD. And, you know we're going to continue to deliver on the same financial profile that we've been talking about all this time. So we're still consider it. We're part way in our long term journey here. We're not done There's still a lot to do in the company and you know, but we're set up to achieve it.

非常感謝，我們感謝您提出的問題以及您對過去三年的總結，您知道我們顯然是從堅實的基礎開始的。我們將三家公司放在一起，在那段時間我們做了很多投資組合分析和重組，正如您在本季度所宣布的那樣，我們繼續這樣做。正如您非常正確地提到的，您知道我們重建了領導團隊，並且您知道其下的許多層級，儘管我們仍然擁有多家公司的許多遺留團隊。因此，我們確實非常關注人才和規模化。你知道，在那段時間我們已經擴展了，例如，我們的 Decipher 實驗室能夠處理三倍甚至更多的數量，這是必要的，我們在周轉時間和類似的事情方面沒有錯過任何一個節拍。所以，你知道我為此歸功於我們的團隊。我們聘請了傑出的領導者，他們知道自己在做什麼，以補充我們已經擁有的人才。我們也知道他們在做什麼，從那時起我們已經走了很長一段路，你知道我對收入、持續的收入增長、我們為你提供服務的能力感到非常自豪，知道我們自己的期望和我們設定的期望。然後，非常重要的是，我們有機會向您提供我們一直在討論並在今天的電話會議上分享的調整後 EBITDA 的財務狀況。因此，正如我所期望的那樣，這一切都非常好，當我展望2025 年及以後時，這一切都是回顧過去的，很多都是一樣的，我們仍然非常專注於成功產生收入增長的產品組合，我們今天正在推動的獲利能力。我們將繼續投資我們談論的這三項重要策略舉措，您知道，這將在未來帶來長期成長。我們在那三年的時間內收購了一家公司 C2I，這構成了你知道的主要舉措之一，MRD。而且，您知道我們將繼續提供我們一直在談論的相同財務狀況。所以我們還在考慮。我們的長期旅程才剛開始。我們還沒完成 公司還有很多工作要做，你知道，但我們已經準備好實現它。

Perfect. On the second, on the Decipher volume that seems to be continuing the trend of strong growth this year on the heels of the NCC and guideline level upgrade. Could you help us understand the underlying adoption growth drivers here, is it mostly new physicians adopting or is it existing physicians who are increasing order volumes or both?

完美的。其次，在 NCC 和指南級別升級之後，Decipher 數量似乎延續了今年強勁成長的趨勢。您能否幫助我們了解潛在的採用成長驅動因素，主要是新醫生採用還是現有醫生正在增加訂單量，或者兩者兼而有之？

Yeah, great question. Let me start by dealing with the you know, various categories of growth that we're seeing. When you look at the NCCN risk levels, we are seeing relatively consistent growth across low intermediate and high risk. And so the biopsy based part of the business is driving that growth. And we're happy to be able to see that and it's the NCCN guidelines really that address all those risk categories and prognosis and in those categories that's really causing physicians to existing physicians to double down on decipher and the use of decipher across their entire patient population, which we're seeing more as well as new physicians coming on to adopt decipher because it is the only test molecular diagnostic test with the level one B RNA based test with level one B going forward. Of course, we also have the metastatic indication which adds another 30,000 patients. And as I mentioned in the prepared remarks, we're working on the tech assessment for that and the reimbursement and the launch that will start to ramp in the end of 2025. And for that, you know, at that point, we get to what ultimately has been our goal, every patient with prostate cancer should potentially get a molecular diagnostic and decipher as the you know, market leading tests that they should really, they should really be benefiting from.

是的，很好的問題。讓我先談談我們所看到的各種類型的成長。當你觀察 NCCN 風險等級時，我們發現低、中、高風險的成長相對一致。因此，基於活檢的業務部分正在推動這一成長。我們很高興能夠看到這一點，NCCN 指南確實解決了所有這些風險類別和預後，在這些類別中，真正導致現有醫生加倍努力破解和在整個患者中使用破解我們看到越來越多的人以及新的醫生開始採用Decipher，因為它是唯一基於B 級RNA 的測試分子診斷測試，並且未來將有B 級測試。當然，我們還有轉移適應症，這又增加了30,000名患者。正如我在準備好的演講中所提到的，我們正在為此進行技術評估以及補償和發布，該專案將於 2025 年底開始加速。為此，你知道，到那時，我們就達到了我們的最終目標，每個前列腺癌患者都應該接受分子診斷和破譯，正如你所知，市場領先的測試，他們真的應該，他們真的應該從中受益。

Perfect. Thank you so much guys.

完美的。非常感謝你們。

Yeah, thank you. By the way, I should just mention one other driver which was you know, as we've talked about before getting commercial payers for decipher. And we had I think it was Q2. We mentioned it maybe it was the earliest Q1 that we had a significant one that added a lot of new covered lives and we're continuing on that.

是的，謝謝。順便說一句，我應該提一下您知道的另一位司機，正如我們在獲得商業付款人進行解密之前所討論的那樣。我認為這是第二季。我們提到，這可能是我們最早的第一季度，我們有一個重要的，增加了很多新的承保生活，我們正在繼續這樣做。

Yeah.

是的。

That was as of middle of the first quarter announced on the first quarter call in Q2. Thanks to all of the above.

這是截至第二季第一季電話會議宣布的第一季中期的情況。感謝以上所有內容。

Yeah, thanks. Sorry. Next question.

是的，謝謝。對不起。下一個問題。

Our next question comes from Andrew Brackmann with William Blair. Andrew. Go ahead with your question.

我們的下一個問題來自安德魯·布拉克曼和威廉·布萊爾。安德魯.繼續你的問題。

Hi, good afternoon. Thanks for taking the questions. Maybe to start here just on testing volume and in particular how you're thinking about growth there for 2025. I know there's still a couple of months left in the year, but super high level I know law of large numbers is probably at play here but any other drivers or headwinds or tail winds that we should be considering and either decipher or affirm it next year. Thanks.

嗨，下午好。感謝您提出問題。也許從測試量開始，特別是您如何考慮 2025 年的成長。我知道今年還剩幾個月，但超高水平我知道大數定律可能在這裡發揮作用，但我們應該考慮並在明年破解或確認任何其他驅動因素或逆風或順風。謝謝。

Yeah, so Andrew, thanks for that I'll let Rebecca jump in here too, but we're not we're obviously we're not ready to give numbers for 2025 yet. We're still working through our budget and our plan I gave some color today on a firmer kind of indicating high single digit growth there, which is more of a revenue point than a volume point. I didn't get into the level of detail for that. The first of five will start to drive more next year in Afirmer. But of course, you do have the law of large numbers there on the cipher's side, it's back to that metastatic and then continued growth and you know, penetrating the market that coming into this year was only 35% penetrated. Now, in 2025 we're going to be able to serve the entire market including metastatic, which will as I mentioned, will help in the back half of next year. We should continue to drive more penetration into that market and more share. Especially given the prolific, you know evidence that we have for decipher with you know, hundreds of studies involving the test and as you saw and you know, I mentioned Stampede and any of you who paid attention to the stuff we talked about at ESMO, you know, Decipher's moving down the care continuum into prediction of chemotherapy benefit and which patients will benefit and which patients won't benefit. So lots of exciting things to come for decipher and that's why we continue to remain quite excited about our testing growth for not just 25 but beyond and bridging us to the long term drivers.

是的，安德魯，謝謝你，我會讓麗貝卡也加入進來，但我們還沒準備好，我們顯然還沒有準備好提供 2025 年的數字。我們仍在製定預算和計劃，今天我給了一些顏色，以更堅定的方式表明那裡有高個位數增長，這更多的是收入點而不是銷售點。我沒有詳細討論這一點。明年，五個中的第一個將開始在 Afirmer 中發揮更多作用。但當然，密碼方面確實有大數定律，它又回到了轉移，然後持續成長，你知道，今年進入的市場滲透率只有 35%。現在，到 2025 年，我們將能夠為包括轉移在內的整個市場提供服務，正如我所提到的，這將在明年下半年有所幫助。我們應該繼續推動對該市場的更多滲透和更多份額。特別是考慮到我們有大量的證據可以破譯，數百項涉及測試的研究，正如你所看到的，你知道的，我提到了 Stampede 以及任何關注我們在 ESMO 談論的內容的人，你知道， Decipher 正在將護理連續性轉向化療益處的預測以及哪些患者將受益，哪些患者不會受益。如此多令人興奮的事情即將到來，這就是為什麼我們繼續對我們的測試成長感到非常興奮，不僅是 25 年，而且是更久，並將我們與長期驅動因素聯繫起來。

Absolutely just a couple of things to add there, Andrew. And speaking again more on a revenue than a volume basis.

安德魯，絕對只是補充幾件事。再次強調的是收入而不是數量。

You know, we are seeing these market sizes unfortunately grow from an incidence perspective. So we are seeing kind of a low to mid single digit growth rate for both the affirm and Decipher markets. Additionally, on a total revenue basis, I called out the $6 million headwind for Envisio. So that's worth considering. And then also in our you know in our prepared remarks, we spoke about product revenue being muted for next year. So, so take that into account and also think about, you know, the BioPharma business being one that we have not incrementally invested in. And so, you know, that could also be plus or minus a bit next year. We aren't necessarily guiding to that today, but something to it's not something that we're today very, we're investing in. But when you sum all that up, given the dynamics that mark shared for Afirma and Decipher. Again, we are very confident in our ability of those two tests to bridge us, you know, to our long term growth drivers in 25 and beyond, and we feel very confident about our position entering next year and we're quite excited for it.

您知道，不幸的是，從發生率的角度來看，我們看到這些市場規模正在成長。因此，我們看到確認和解密市場都呈現低至中個位數的成長率。此外，在總收入的基礎上，我指出 Envisio 面臨 600 萬美元的阻力。所以這是值得考慮的。然後，在我們準備好的演講中，我們談到了明年的產品收入將被抑制。因此，考慮到這一點，並考慮一下，你知道，生物製藥業務是我們尚未增量投資的業務。所以，你知道，明年這也可能會增加或減少。我們今天不一定會指導這一點，但我們今天並沒有投資。但當你總結所有這些時，考慮到 Mark 為 Afirma 和 Decipher 所共享的動態。再說一次，我們對這兩項測試的能力非常有信心，它們能夠幫助我們實現 25 年及以後的長期成長動力，我們對明年進入的位置非常有信心，我們對此感到非常興奮。

Terrific. I'll stick on another financial question, this one on the profitability and cash flow. I mean you've raised your cash projections or you're finishing end of the year cash projections by about 50 million since the start of the year. I think it was just five months ago where you threw out that 25% adjusted ebit margin target and here you post 24%. So what's a reasonable way to think about further leverage in this model going forward? And I guess related to that, how do you sort of intend to deploy cash here over time? Thanks.

了不起。我將繼續討論另一個財務問題，即獲利能力和現金流。我的意思是，自年初以來，您已經提高了現金預測，或者您將完成年終現金預測約 5000 萬美元。我想就在五個月前，你們還提出了 25% 的調整後息稅前利潤率目標，而現在你們公佈了 24%。那麼，考慮該模型未來進一步發揮槓桿作用的合理方法是什麼？我想與此相關的是，隨著時間的推移，您打算如何在這裡部署現金？謝謝。

Well, the model is and you're seeing it is clearly leverageable in the specialty diagnostics channel where I've mentioned, we've got 50 sales reps roughly and decide from 50 affirm and we've added a handful of sales reps during the year because the effectiveness of our sales team is just second to none. I mean, they really are a best in class team in both categories and they're doing an amazing job. So as we grow, we'll continue to see some leverage there on the sales and marketing side. You know, I don't want to guide to ultimately what the margin will be I've always said, I think a specialty business like ours should be able to generate a sustainable 25% on an annual basis. You will see quarterly fluctuations in that because spending is not linear. And also, you know what the dials that we choose to turn you know, there are some, there's some optionality there right. We've got three really important projects that I talk about that the make up slightly more than half of our 60 million run rate of R&D a year. And you know, we'll continue to invest in those at an appropriate level in order to be able to launch products on a timely basis and generate, importantly, generate the evidence that we need to support those products. We've always said Veracyte that, you know, developing the product is just the beginning of the journey, creating the evidence to support it and drive adoption and ultimately guidelines. And of course, reimbursement is as important if not more important than the assay itself. And so we'll dial, turn those dials as we need to in order to make sure that we continue to deliver on our growth expectations.

嗯，這個模型是，你會看到它在我提到的專業診斷管道中顯然是可以利用的，我們大約有 50 名銷售代表，並從 50 名確認中做出決定，並且我們在年，因為我們銷售團隊的效率是首屈一指的。我的意思是，他們確實是這兩個類別中最好的團隊，而且他們做得非常出色。因此，隨著我們的成長，我們將繼續在銷售和行銷方面看到一些槓桿作用。你知道，我不想指導最終的利潤是多少，我總是說，我認為像我們這樣的專業企業應該能夠每年產生可持續的 25% 的利潤。您會看到季度波動，因為支出不是線性的。而且，你知道我們選擇轉動什麼轉盤，你知道，有一些，有一些可選性。我們有三個非常重要的項目，我談到它們占我們每年 6,000 萬研發投入的一半多一點。你知道，我們將繼續在適當的水平上進行投資，以便能夠及時推出產品，並產生（重要的是）我們需要支持這些產品的證據。我們總是對 Veracyte 說，開發產品只是旅程的開始，創造支持它的證據並推動採用和最終的指導方針。當然，報銷與檢測本身一樣重要，甚至更重要。因此，我們將根據需要進行調整，以確保我們繼續實現成長預期。

Yeah, and just you know, a comment or two to add into that very thorough comment market had. But you know, Andrew, you're correct. We have you know, when we were at your conference earlier in the year and we put out the 25% target. We were just coming off of 15% quarter. Thanks to a number of different levers that came through over the course of 2024. We're now looking and guiding to 700 basis points of adjusted EBITDA expansion here in 2024. Which is what is quite an astounding feat. And we're quite excited about it, that being said for the reasons that Marc shared, you know, we are thinking about this on a from a balance perspective going forward and absolutely are committed to increasing or different further differentiating our financial profile, but that's going to come you know, step function. It won't be necessarily a step function change like we saw through 2024 it will be more incremental as we think through the balance between investing for long term growth and delivering profitability. Additionally, you know, we also had a decent have had a decent benefit of prior period cash collections this year, which obviously will continuously benefit ASP on an ongoing basis. But those do flow down in any given period at 100%. So just think about that as well on a go forward basis.

是的，你知道，一兩則評論可以添加到那個非常徹底的評論市場。但你知道，安德魯，你是對的。你們知道，今年早些時候我們參加你們的會議時，我們提出了 25% 的目標。我們剛結束 15% 的季度。感謝 2024 年採取的許多不同手段。我們現在正在尋找並指導 2024 年調整後 EBITDA 擴張 700 個基點。這是一個相當令人震驚的壯舉。我們對此感到非常興奮，考慮到馬克分享的原因，我們正在從平衡的角度考慮這一問題，並且絕對致力於增加或改變進一步差異化我們的財務狀況，但是你知道，這將會出現，階躍函數。這不一定是像我們在 2024 年看到的那樣的階梯式功能變化，當我們考慮長期成長投資和實現盈利之間的平衡時，它會更加漸進。此外，您知道，今年我們也從前期現金收款中獲得了不錯的收益，這顯然將持續使 ASP 受益。但這些在任何給定時期內確實會以 100% 的速度下降。因此，請在未來的基礎上考慮這一點。

Thanks Rebecca. And to your question on deployment, no change in our philosophy around deployment. That there aren't a lot of really attractive opportunities to deploy cash in our space to you know, to grow our business in a way that wouldn't require a significant investment in evidence development over multiple years. And we have a lot of that going on ourselves. In fact, we've actually paused some projects that would require us to do that because it's the right thing to do not just financially, but more importantly, from a resourcing and a focus standpoint, you know, execution is important and we execute well because we're very focused on and the whole company is very focused on what we're trying to accomplish. So we would be clearly very diligent in thinking about how to deploy capital. But more importantly, how to deploy our teams resources, our management attention and focus and the other assets that we have in the company.

謝謝麗貝卡。至於你關於部署的問題，我們對部署的理念沒有改變。據你所知，在我們的領域並沒有很多真正有吸引力的機會來部署現金，以不需要多年來對證據開發進行大量投資的方式來發展我們的業務。我們自己也有很多這樣的事情發生。事實上，我們實際上已經暫停了一些需要我們這樣做的項目，因為這不僅在財務上是正確的事情，而且更重要的是，從資源和焦點的角度來看，你知道，執行很重要，我們執行得很好因為我們非常專注，整個公司也非常專注於我們想要實現的目標。因此，我們顯然會非常勤奮地思考如何配置資本。但更重要的是，如何部署我們的團隊資源、管理層的注意力和重點以及我們在公司擁有的其他資產。

Great color. Thanks so much.

顏色很棒。非常感謝。

You're welcome.

不客氣。

Our next question comes from Lou lee of U Bs.

我們的下一個問題來自UBs的Lou lee。

Lou. Go ahead with your question.

盧.繼續你的問題。

Great. Thank you so much for taking my questions. I guess like the first one wanted to going back to Decipher. So you mentioned the metastatic going to benefit in the second half. Any way that you can kind of like quantify the benefit to it? And then do you think that they're going to be have some like ASP pressure initially just because it takes time to kind of negotiate with the commercial players?

偉大的。非常感謝您回答我的問題。我想第一個想回到《破解》。所以你提到轉移將在下半年受益。有什麼方法可以量化它的好處嗎？那麼您是否認為他們最初會面臨 ASP 壓力，只是因為與商業參與者進行談判需要時間？

Yeah, great question. I'll let Rebecca handle the ESP part, but in terms of the metastatic benefit, you should think of it as about 10% of the total market. So about in the US 300,000 incidences a year of which about 30,000 are new incidences of metastatic, right? So don't think of it in terms of the prevalent population, but the new incidences. So, 30,000 will launch the test, think of it as two thirds Medicare related. And so that's why the tech assessment and the process we're going through there is so important. And then you're absolutely right, there will be a ramp up of commercial payers. But, you know, I don't think it creates ASP pressure initially because, you know, we will see a ramp in the volume of the test as well. So, the test will grow. I think the test will grow as we bring on commercial payers. In the same way you've seen on the localized setting. Our test has grown as we've added more commercial pairs.

是的，很好的問題。我會讓 Rebecca 處理 ESP 部分，但就轉移效益而言，你應該將其視為整個市場的 10% 左右。那麼，美國每年大約有 30 萬例，其中約 3 萬例是新發轉移病例，對嗎？因此，不要從流行人口的角度來考慮，而是從新發病例的角度來考慮。因此，30,000 人將啟動該測試，將其視為三分之二與醫療保險相關。這就是為什麼技術評估和我們正在經歷的過程如此重要。然後你是絕對正確的，商業付款人將會增加。但是，我認為它最初不會造成 ASP 壓力，因為我們也會看到測試量的增加。因此，測試將會成長。我認為隨著我們引入商業付款人，測試將會增加。與您在本地化設定中看到的方式相同。隨著我們添加更多商業對，我們的測試也在不斷增長。

Yeah. No, that's exactly right. I was completely agree with you for the Medicare for the Medicare patients, our Medicare advantage patients. We absolutely should be getting the same ASP as we do on the biopsy and RP side and then for commercial, you know, we will be billing with the same code. So we expect to get some reimbursement there. But it'll take you know, some period of time to get this under contract for many of the parents. But not all some of some payers, we do have a blanket statements in there that new incremental testing does get paid. So, you know, I think it's going to be just like it always is right. You're going to grind higher on your ASP over time, just like we've shown our ability to do so with Afirma and decipher and I don't view Metastatic to be any different.

是的。不，完全正確。我完全同意您關於為醫療保險患者提供醫療保險、為我們的醫療保險優勢患者提供醫療保險的觀點。我們絕對應該獲得與活檢和 RP 方面相同的 ASP，然後對於商業，您知道，我們將使用相同的代碼進行計費。所以我們希望在那裡得到一些補償。但你知道，對許多家長來說，需要一段時間才能簽約。但並非所有付款人都這樣做，我們確實有一個籠統的聲明，即新的增量測試確實會得到報酬。所以，你知道，我認為這將永遠是正確的。隨著時間的推移，您的 ASP 將會更高，就像我們透過 Afirma 和 decipher 展示了我們這樣做的能力一樣，我不認為 Metastatic 有任何不同。

Okay, I appreciate that. My second question on the product revenue, It seems like there was an 18% sequential decline. I mean you mentioned it's a supply chain issues. Do you think it's getting worse in the quarter? Or it's just like taking longer to solve the issue? Just wanted to get a little bit more color on that. Thank you.

好的，我很欣賞。我關於產品收入的第二個問題，似乎較上季下降了 18%。我的意思是你提到這是供應鏈問題。您認為本季情況會變得更糟嗎？或只是需要更長的時間來解決問題？只是想在上面多一點色彩。謝謝。

Yeah, it is. But some of it's intentional as Rebecca mentioned, we're managing demand, right? We don't want to see our customers impacted and patients impacted. So part of what we're doing to mitigate supply chain risk is managing the demand. And so that's why Rebecca set the expectation of a muted go forward growth next year. I actually think about next year as more of a transition year for the product business, we are developing in parallel multiple tests including Decipher on PCR and Prosigna on NGS and submitted Prosigna on the NAN and we're also developing nasal swab. We're going to be managing through the supply chain challenges and then driving reimbursement country by country for our tests when we're ready to launch. So 2025 don't think of it as you know, the product line is a revenue driver next year. In fact, on the contrary, I would think of it as said you did and you know, hold back expectations there. We've got a lot to do and we want to make sure we hit the markets right and launch the right test at the right time with the right kind of, you know, strength and infrastructure behind it.

是的，確實如此。但正如麗貝卡所提到的，其中一些是有意為之的，我們正在管理需求，對嗎？我們不希望看到我們的客戶和患者受到影響。因此，我們為降低供應鏈風險所做的部分工作就是管理需求。這就是為什麼麗貝卡設定了明年成長緩慢的預期。事實上，我認為明年更多的是產品業務的過渡年，我們正在並行開發多項測試，包括PCR 上的Decipher 和NGS 上的Prosigna，並在NAN 上提交了Prosigna，我們還在開發鼻拭子。我們將應對供應鏈挑戰，然後在準備啟動時為我們的測試逐個國家提供報銷。所以2025年不要像你知道的那樣想，產品線是明年的收入驅動力。事實上，恰恰相反，我會像你所說的那樣思考，你知道，不要抱持期望。我們還有很多工作要做，我們希望確保我們正確進入市場，並在正確的時間啟動正確的測試，並擁有正確的實力和基礎設施。

Appreciate that.

很欣賞這一點。

Our next question comes from Tejas Savant with Morgan Stanley. Tejas. Go ahead with your question.

我們的下一個問題來自摩根士丹利的 Tejas Savant。特哈斯。繼續你的問題。

Hello, this is Yuko on the call for Tajas. Thank you for taking our questions. On Decipher, you previously talked about running an awareness campaign on back of reimbursement for metastatic prostate cancer. Given this will be a new population for you and even more broadly for prostate classifiers. How much market building do you think you'll need to facil you need to do to facilitate adoption of decipher use in that setting?

大家好，我是 Yuko，正在為 Tajas 通話。感謝您接受我們的提問。在 Decipher 上，您之前曾談到在轉移性前列腺癌報銷的基礎上進行宣傳活動。鑑於這對您來說將是一個新的人群，對於更廣泛的前列腺分類器來說也是如此。您認為您需要做多少市場建設才能促進在該環境中採用解密使用？

There's definitely some but really the benefit here is it's the same, largely the same customer base. It's the urologists in particular that we're, we're engaging with for the most part and you know, it starts with training our sales force, which we'll be doing early next year and then the sales force will be out there in a measured way, talking to their customers about the metastatic setting when to use the test, how to use the test, how to interpret the test report and so on. And so it's more of the same. I don't think there's anything, you know, we'll do, we'll do some new product market development, but a lot of it is just continuing what we already do for the localized setting. So.

肯定有一些，但真正的好處是它們是相同的，基本上是相同的客戶群。尤其是泌尿科醫生，我們在很大程度上與他們打交道，你知道，它從培訓我們的銷售人員開始，我們將在明年初進行，然後銷售人員將在以一種衡量的方式，與客戶談論轉移設定何時使用測試、如何使用測試、如何解釋測試報告等。所以它更像是一樣的。我認為我們不會做任何事情，我們會做一些新產品市場開發，但其中很多只是繼續我們已經為在地化環境所做的事情。所以。

And from a spend perspective, I wouldn't think about that as a change in inflection of the curve of sales and marketing spend for next year just to get that out there as well.

從支出的角度來看，我不會認為這是明年銷售和行銷支出曲線的變化，只是為了實現這一點。

Agreed.

同意。

Got it. That, that was super helpful. Thank you. And then I think you also talked about Bethesda five representing 5 to 10% of your total Pharma test volume. Is that volume you're already running mostly associated with commercial or are you also running Medicare volumes of? Well, I'm trying to understand whether we could see volume uplift in addition to ASP as a result of the LCD.

知道了。那，這非常有幫助。謝謝。然後我想您還談到了 Bethesda 5 佔您製藥測試總量的 5% 到 10%。您已經運行的該卷主要與商業相關還是您也在運行醫療保險卷？嗯，我試著去了解液晶顯示器除了帶來平均售價之外，我們是否還能看到銷售量的提升。

Yeah. That's a good question. I think I would think about them as obviously related not perfectly correlated but related. And the reason why I say that is you know, I think when it comes down to it we do run, we do report out some pieces of Bethesda five for commercial payers, obviously on the, it in general, it does follow the same mix. And so I think when it comes down to it, you know, we have we have the benefit potentially on the volume side for Bethesda five and obviously also on the ASP side again, it's around the edges though. So I don't think of it as I don't want to, it's an important opportunity to expand our market population. That being said it's a very small proportion of the population. And therefore I don't want, you know, it's going to be kind of a nice tailwind but not a huge driver. So I think about it as being helpful. But there are so many other things from an execution perspective that the team has in line of sight to, to drive you know, the revenue volume, the revenue growth that we shared with regard to our expectations for next year that you know, that's just kind of a rounding error to that.

是的。這是個好問題。我想我會認為它們是明顯相關的，不是完全相關的，而是相關的。我這麼說的原因是你知道，我認為歸根結底，我們確實在運行，我們確實為商業付款人報告了貝塞斯達五的一些內容，顯然，總的來說，它確實遵循相同的組合。所以我認為歸根結底，我們在 Bethesda 5 的銷售方面有潛在的優勢，顯然在 ASP 方面也有潛在的優勢，但它處於邊緣。所以我不認為這是我不願意的，這是擴大我們市場人口的重要機會。話雖如此，這只是人口中很小的一部分。因此我不希望，你知道，這將是一種很好的順風，但不是一個巨大的推動力。所以我認為這很有幫助。但從執行的角度來看，團隊還有很多其他事情需要考慮，以推動你知道，我們分享的關於明年的預期的收入量和收入增長，你知道，這只是有點捨入誤差。

And just to add to that, I think is exactly right. And the LCD covers the Medicare population of course, and the Medicare population, it's inverted from the decipher comparison. It's actually the smallest part of the population in thyroid cancer. So more like roughly a third or so, I may be slightly off there but it's in that zone. So, yeah that's the new opportunity. The commercial payers, as Rebecca said, some are some are already there.

補充一點，我認為這是完全正確的。當然，LCD 涵蓋了 Medicare 人群，而 Medicare 人群，它與解密比較是相反的。它實際上是甲狀腺癌人群中最小的一部分。所以更像是大約三分之一左右，我可能稍微偏離了那裡，但它在那個區域。所以，是的，這就是新的機會。正如麗貝卡所說，商業付款人有些已經存在了。

Got it. Thank you so much.

知道了。太感謝了。

Yeah, our next question comes from Sung Ji Nam with Scotiabank. Sung Ji, go ahead with your question.

是的，我們的下一個問題來自豐業銀行的 Sung Ji Nam。宋吉，繼續你的問題。

Hi, thanks for taking the questions and congrats on the quarter. Maybe just another one on Decipher. Great to see differentiated clinical studies there like such as the Stampede and then down, especially for the metastatic population. And you know, obviously a lot going on there as well. Just kind of curious if there, you know, if you do you need further guideline inclusion there in order to drive growth as well or do you anticipate additional guideline in there? And then just specifically for the Stampede trial, are there opportunities for decipher to become like a companion diagnostic of some sort? And also could that trial translate into you know, adoption in the US in the US market as well?

您好，感謝您提出問題並祝賀本季。也許只是《Decipher》上的另一篇文章。很高興看到有差異化的臨床研究，例如 Stampede，然後下降，特別是針對轉移人群。你知道，顯然那裡也發生了很多事。只是有點好奇，您知道，您是否需要進一步納入指南以推動成長，或者您是否預計會有更多指南？然後，專門針對 Stampede 試驗，破解是否有機會成為某種伴隨診斷？而且該試驗是否也可以轉化為美國市場的採用？

Yes, so great question. I think on the guideline side, if you think about localized, we got a lot of traction without guidelines. And then every time new guidelines came out, the further talked about the positive benefits of Decipher, including in the most recent ones having a table that literally for localized disease tells a physician what to do based on the Decipher score. Each time that's happened, that's caused a significant improvement and increase in the adoption. And so on the Metastatic side, I expect it to follow the same. You know, guidelines aren't necessary at the beginning, but they're certainly necessary in order to drive the adoption across the entire cohort and to be able to get to 300,000 ultimately patients across the entire disease spectrum. So, we will continue to use evidence like stampede and others. And stampede is not the only one there are others out there that support the use of decipher in a metastatic setting for both prognostic and predictive abilities.

是的，很好的問題。我認為在指南方面，如果你考慮本地化，我們在沒有指南的情況下獲得了很大的吸引力。然後每次新的指南出現時，都會進一步討論 Decipher 的積極好處，包括在最近的指南中，有一張針對局部疾病的表格，可以根據 Decipher 評分告訴醫生該做什麼。每次發生這種情況，都會帶來顯著的改善和採用率的增加。因此，在轉移方面，我希望它也能遵循同樣的原則。您知道，指南在一開始並不是必需的，但為了推動整個隊列的採用並最終覆蓋整個疾病譜系的 300,000 名患者，指南無疑是必要的。因此，我們將繼續使用踩踏等證據。踩踏並不是唯一的一種，還有其他一些支援在轉移環境中使用解密來提高預後和預測能力。

And you know that's such a core part of what we do here where I say that that evidence generation and partnering with others to do that. So we expect that to help us drive guideline inclusion in even more positive guideline inclusion in the future, both localized potentially and metastatic.

你知道，這是我們在這裡所做的工作的核心部分，我說的是證據生成並與其他人合作來做到這一點。因此，我們希望這能夠幫助我們在未來推動指南納入更積極的指南納入，無論是局部潛在的還是轉移性的。

On your question on, you know, companion diagnostic, I mean, yeah, sure. As you get into the prediction side, whether it's a companion diagnostic or it's a diagnostic that's used to determine the appropriate treatment without necessarily being on the label TBD. But you know, it's either way, I think what it does is it drives more and more physicians to recognize that using decipher throughout the patient's care continuum, no matter what level of risk they're dealing with that patient is beneficial for the patient and it's beneficial for them. It gives them more information. The Stampede trial demonstrated that you know, today using tumor volume is one way to try and figure out what patients to put on dose Taxol. But this gives you a higher resolution opportunity to figure out which patients are truly going to benefit and which aren't. And so the more studies that incorporate those kinds of outcomes and results, I think the better adoption and the better inclusion and guidelines.

關於你的問題，你知道，伴隨診斷，我的意思是，是的，當然。當你進入預測方面時，無論它是伴隨診斷還是用於確定適當治療的診斷，而不必貼上「TBD」標籤。但你知道，無論哪種方式，我認為它的作用是促使越來越多的醫生認識到，在整個患者的護理過程中使用破譯，無論他們處理該患者的風險程度如何，對患者都是有益的，並且這對他們有利。它為他們提供了更多資訊。Stampede 試驗表明，如今使用腫瘤體積是嘗試確定哪些患者需要接受紫杉醇劑量的一種方法。但這為您提供了更高解析度的機會來確定哪些患者真正會受益，哪些患者不會受益。因此，納入這些結果和結果的研究越多，我認為採用的效果就越好，包容性和指南就越完善。

Do you want to comment on the usefulness or utility of Stampede in the US setting?

您想對 Stampede 在美國環境中的實用性或實用性發表評論嗎？

That I miss that part of your question? Thanks, Rebecca.

我想念你問題的部分嗎？謝謝，麗貝卡。

Absolutely. I think of decipher as a global, you know, its studies really are very global in nature in some of the US studies we've had PS from Europe involved and this is one of the reasons why we're so excited about the IVD test because so many key opinion leaders and physicians outside the US are already aware of decipher, they've been involved in studies. And the same way, I do think the US will look at the, you know, the trials that have been run out of the UK and other European locations as being somewhat compelling. Now, whether we need to run, you know, smaller studies in the US as well is to be determined. We also want to make sure that we're, we're dealing with all populations including underrepresented and diverse populations too. And so to the extent we have to supplement studies with additional clinical trials, we will do that in that part of the R&D spend I talked about there isn't those three big strategic drivers meaningful, you know, a few million dollars, more than a few million dollar proportion of that is continuing sustaining clinical studies to drive decipher and the same a little bit on affirm as well.

絕對地。我認為Decipher 是一個全球性的研究，你知道，在美國的一些研究中，它的研究本質上確實是非常全球性的，我們有來自歐洲的PS 參與其中，這就是我們對IVD 測試如此興奮的原因之一是因為美國以外的許多關鍵意見領袖和醫生已經知道破解，他們已經參與了研究。同樣，我確實認為美國會認為英國和其他歐洲地區已經進行的試驗有些引人注目。現在，我們是否還需要在美國進行較小規模的研究還有待確定。我們還想確保我們正在與所有人群打交道，包括代表性不足和多樣化的人群。因此，在某種程度上，我們必須透過額外的臨床試驗來補充研究，我們將在我談到的那部分研發支出中做到這一點，這三大戰略驅動因素沒有意義，你知道，幾百萬美元，超過其中數百萬美元的部分用於繼續維持臨床研究以推動破譯，以及相同的一點確認。

Got it. That's super helpful and just a quick follow up you guys did mention Hurricanes. Some of your peers have mentioned that is kind of an impact in the quarter. Just curious if there were any, you know, and if not, you know, do you could there be some impact some delayed impact from your standpoint from any of the any disruptions if you will, you know, in terms of patient visits and things like that happening, kind of at the end of three Q and early four Q.

知道了。這非常有幫助，只是快速跟進，你們確實提到了颶風。您的一些同行提到這對本季產生了某種影響。只是好奇是否有任何影響，你知道，如果沒有，你知道，從你的角度來看，是否會因任何干擾而產生一些延遲影響，如果你願意，你知道，在病人就診和其他事情方面就像這種情況發生在第三個Q的結尾和第四個Q的開頭。

I think the short answer is no, we when you look at the weekly graphs of shipments, you see a small dent in the areas where the Hurricanes were impacted. And of course, you know, our hearts and thoughts go out to everybody, whether patients, physicians and others who were impacted by those, those natural events. But the, you know, what we saw was a small dent, but I'd say we've largely recovered from that. And what would you say Rebecca that the effect is less than a day's worth of.

我認為簡短的答案是否定的，當您查看每週的出貨量圖表時，您會發現受颶風影響的地區出現了小幅下降。當然，你知道，我們的心和想法與每個人同在，無論是病人、醫生或其他受到這些自然事件影響的人。但是，你知道，我們看到的是一個小凹痕，但我想說我們基本上已經恢復了。麗貝卡，如果效果還不到一天的效果，你會怎麼說呢？

I would say in any given quarter, you know, a day or two in the lab fall on one side of, of the quarter or the other. And I kind of put this in that category. Sanji, you know, I'd say it's about a less of a day of volume that we saw earlier this month. And nothing in the really in the third quarter, given the areas impacted.

我想說，在任何特定季度，實驗室裡的一兩天都會落在該季度的一側或另一側。我把它歸類在這一類別。山治，你知道，我想說這比我們本月早些時候看到的一天的交易量要少。考慮到受影響的領域，第三季實際上沒有什麼變化。

Right.

正確的。

Great. Thank you so much.

偉大的。太感謝了。

Stand by for our next question.

等待我們的下一個問題。

Our next question comes from Thomas DeBourcy with Nephron Research. Thomas. Go ahead with your question.

我們的下一個問題來自 Nephron Research 的 Thomas DeBourcy。托馬斯.繼續你的問題。

Hi, guys. I guess just a couple of clean up questions here. First one, I guess just the Nightingale study and just, I think the last update was you know, maybe potential completion of enrollment at the end of this year, early next year. Just any thoughts there on updated timing.

嗨，大家好。我想這裡只有幾個清理問題。第一個，我想只是南丁格爾研究，我想最後一次更新是你知道的，也許可能在今年年底、明年初完成註冊。只是關於更新時間的任何想法。

Yes, Thomas, we actually stopped guiding to when we would finish the study. The one thing I've learned over the three years I've been doing this is we're better at forecasting revenue than we are at forecasting clinical studies because so much of it is outside of our control. And then when you add the extra complexity of a lung based study which seem to be impacted more than others in our experience, it just became, you know, we were chasing something that we couldn't pin down close enough. So we stopped guiding to it. We're continuing to enroll. We have close to 100 sites that are enrolling at a reasonable clip and we'll update you again next when we've completed enrollment.

是的，托馬斯，我們實際上停止了對何時完成研究的指導。在這三年裡我學到的一件事是，我們更擅長預測收入，而不是預測臨床研究，因為其中許多都超出了我們的控制範圍。然後，當你添加基於肺部的研究的額外複雜性時，根據我們的經驗，該研究似乎比其他研究受到的影響更大，你知道，我們正在追逐一些我們無法足夠接近的東西。所以我們停止了對它的指導。我們還在繼續報名。我們有近 100 個網站正在以合理的速度進行註冊，接下來當我們完成註冊後，我們將再次向您通報最新情況。

Then just one other question. Just the 10million to 15 million milestone payment in Q4 adding to cash just is that just kind of, I guess a BioPharma agreement where you hit milestones there or any other contact?

那麼還有一個問題。只是第四季度 1000 萬到 1500 萬的里程碑付款加上現金只是這樣，我猜是生物製藥協議，您在那裡達到了里程碑或有任何其他聯繫？

Yeah, happy to provide some context to that. Thomas, it's actually more on the expense side than it is on the revenue side. On the expense side, we have a potential milestone payment that we have a high probability as you'll see in the queue tomorrow of paying in the fourth quarter, that's around $5 million. We also have a similar amount of CapEx that we expect to spend in the fourth quarter for development projects that are kicking off here and, you know, at the beginning of 25 and then the remainder is some working capital that we expect to have in the fourth quarter. So I would say it's those three buckets.

是的，很高興為此提供一些背景資訊。湯瑪斯，實際上更多的是支出方面而不是收入方面。在費用方面，我們有一個潛在的里程碑付款，正如您明天在第四季度付款的隊列中看到的那樣，我們很有可能會看到這一付款，約為 500 萬美元。我們也有類似數量的資本支出，我們預計在第四季度用於正在啟動的開發項目，你知道，在 25 年初，然後剩下的就是我們預計在 2019 年開始的一些營運資金。所以我想說的是這三個桶子。

Okay. Thank you very much. Appreciate it.

好的。非常感謝。欣賞它。

Thank you.

謝謝。

Stand by for our next question.

等待我們的下一個問題。

Our next question comes from Mike Matson with Needham. Mike, Go ahead with your question.

我們的下一個問題來自李約瑟的麥克馬特森。麥克，繼續你的問題。

Yeah, thanks. So just you know, you've had some pretty good pricing this year. I was wondering if you could just talk about what's been driving that to what degree that would be sustainable into next year?

是的，謝謝。所以你知道，今年你的定價相當不錯。我想知道您能否談談是什麼推動了這一趨勢到明年可持續發展到什麼程度？

Sure, happy to Mike. So I would say that pricing has been a journey over the last couple of years. As we have looked at you know, both the original going back to 2021 the code change from Afirma to from GEC to GSC. If you recall in 22 we had a bit of a headwind there and, and over the course of 23 and 24 we've cleaned a lot of that up and benefited from prior period, collections tied to doing So, I think that that's been one driver, but I think the bigger driver is just the effectiveness of our managed care team and our billing teams. We have effectively, you know, put in place a team here that are they rock stars and they're effectively getting, you know, a number of contracts and coverage, signed up for both the firm and Decipher and, you know, every time we think we're kind of reaching the kind of flattening of the curve if you will. They pull something else out. And so I think as we think about where we are at now, we've made a ton of progress and you know, at some point in time that that portion of the curve will have to flatten. And as we look into next year, you know, I don't know if we're ready to say it's going to flatten fully because, you know, prior period collections have been such a big portion of the outperformance of the story, both on a cash and on a margin perspective this year. But, you know, it's something that something that we're keeping a close eye on and, and eventually, unless, you know we'll get to a rate where we've had the coins become more incremental and less. You know, step function changes like we've had over the last year or two. So again, I'd like to say a huge thanks to, to those two teams, they work incredibly well together and they do amazing work and, and obviously a big piece of that this year has been the large commercial payer that we got for Decipher in the first quarter that mark mentioned earlier. So all is well there. And you know, the goal is to keep on keeping on with regard to the great progress those teams are making.

當然，麥克很高興。所以我想說，定價是過去幾年的一個歷程。如我們所見，您知道，最初的程式碼可以追溯到 2021 年，程式碼從 Afirma 更改為 GEC 更改為 GSC。如果你還記得22年我們在那裡遇到了一些逆風，並且在23年和24年期間我們已經清理了很多東西並從之前的時期、與這樣做相關的收藏中受益，我認為這是一個驅動因素，但我認為更大的驅動因素是我們的管理式醫療團隊和計費團隊的效率。你知道，我們在這裡有效地組建了一支團隊，他們都是搖滾明星，他們有效地獲得了許多合約和覆蓋範圍，與公司和 Decipher 簽約，你知道，每次如果你願意的話，我們認為我們已經達到了曲線趨於平坦的程度。他們拉出別的東西。所以我認為，當我們思考我們現在所處的位置時，我們已經取得了很大的進展，而且你知道，在某個時間點，曲線的這一部分將必須變平。當我們展望明年時，你知道，我不知道我們是否準備好說它會完全趨於平緩，因為你知道，前期收藏在故事的出色表現中佔了很大一部分，無論是今年從現金和利潤角度來看。但是，你知道，這是我們正在密切關注的事情，並且最終，除非你知道我們將達到一個讓代幣變得越來越增量和越來越少的速度。你知道，階梯功能發生了變化，就像我們在過去一兩年所經歷的那樣。所以，我想再次對這兩個團隊表示極大的感謝，他們合作得非常好，他們做了令人驚嘆的工作，而且顯然今年的很大一部分是我們獲得的大型商業付款人在第一季度破解前面提到的那個標記。所以一切都很好。你知道，我們的目標是繼續保持這些團隊正在取得的巨大進步。

Okay, great. And then just on the MRD test. So, I understand your reluctance to forecast the trial for the nasal swab. But, you know, in this case, you know, I don't think there's a trial. So, you know, can you just talk about when you expect to really watch that start generating some meaningful revenue?

好的，太好了。然後就是 MRD 測試。所以，我理解您不願意預測鼻拭子試驗。但是，你知道，在這種情況下，我認為不會進行審判。那麼，您能談談您希望什麼時候真正看到它開始產生一些有意義的收入嗎？

Yeah. So, thanks for that. No, it's not a full, you know, trial and clinical utility study. It's the tech assessment process. It's the work that we have to do in our lab to get it ready for launch. We have to run some samples obviously to validate and everything else associated with that. And so, you know we've talked about that being in the first half of 2026 and then it'll ramp from there. But as I mentioned in the opening remarks that I made the our MRD test initially launched in the bladder indication makes sense for us because of both our channel. And that what I just described is that kind of faster path to reimbursement. But that's not where we're going to end with. MRD is a platform and we're going to obviously launch in other indications as well. The fact that its whole genome is very differentiated and we believe that the right long term structure, it fits very well with verasys approach to always running, you know, getting more data by running a whole transcriptome or a whole genome. And I mentioned, you know, some data that was published in European urology with respect to that test and you know, the benefit of that test in identifying residual disease earlier than the standard of care imaging by a meaningful amount. And so we're looking forward to actually being able to launch that test in many other indications over multiple years. But we'll start with bladder. That'll be our proof of concept if you think about it that way.

是的。所以，謝謝你。不，這不是一項完整的試驗和臨床效用研究。這是技術評估過程。這是我們必須在實驗室中完成的工作，以便為發射做好準備。顯然，我們必須運行一些樣本來驗證以及與之相關的其他所有內容。所以，我們已經討論過 2026 年上半年的情況，然後會從那時開始加速。但正如我在開場白中提到的，由於我們的管道，我們最初在膀胱適應症中啟動的 MRD 測試對我們來說是有意義的。我剛才描述的是那種更快的報銷途徑。但這不是我們要結束的地方。MRD 是一個平台，我們顯然也會在其他適應症中推出。事實上，它的整個基因組是非常分化的，我們相信正確的長期結構，它非常適合 verasys 始終運行的方法，你知道，透過運行整個轉錄組或整個基因組來獲取更多數據。我提到過，歐洲泌尿科發表了一些與該測試有關的數據，該測試的好處是比護理成像標準更早識別殘留疾病。因此，我們期待著多年來能夠在許多其他適應症中實際啟動該測試。但我們將從膀胱開始。如果你這樣想的話，這將是我們的概念證明。

Okay. Got it. Thanks.

好的。知道了。謝謝。

Our next question comes from Punit Sua with leerink partners. Puni Go ahead with your question.

我們的下一個問題來自 Punit Sua 和 leerink 合作夥伴。普尼 繼續你的問題。

Yeah. Hi guys. Thanks for the questions here. So, first one on Decipher, I don't know if this was covered in the question earlier. What is the growth rate you were expecting for decipher sort of going forward into 25. I mean, you have NCCN level one B. And I'm just wondering sort of the tailwinds to that the metastatic side, what could contribute to the volume growth. So, just trying to understand what's the right way to think about the growth rate in this business now? From you know, elevated volume level.

是的。嗨，大家好。感謝您在這裡提出的問題。所以，關於 Decipher 的第一個，我不知道之前的問題是否涵蓋了這一點。您預計 25 年後的成長率是多少？我的意思是，你有 NCCN 一級 B。那麼，只是想了解現在考慮該業務成長率的正確方法是什麼？據您所知，音量水平升高。

Well, I think you've mentioned the key things that the tailwinds, I would only add the the more, you know, we get commercial payers as well. The NCCN guidelines, you mentioned the metastatic indication, which I was clear in my remarks, really think of that as starting to ramp in the back half of next year and then beyond. And so, yeah, I if you think about coming into this year, decipher has really grown a lot better than we anticipated. I would put the NCCN guidelines and commercial payers down as the primary reasons why that revenue growth has been so strong. we're not ready to give a guide for next year yet because we're still working through that. But we did say when you look at decipher and affirm together, we feel very bullish about our testing growth going forward without giving that number. I did give some guide for affirm in the high single digits for next year but not ready to do so on the decipher side just yet.

好吧，我想你已經提到了順風的關鍵事情，我只會補充更多，你知道，我們也得到了商業付款。NCCN 指南中，您提到了轉移跡象，我在發言中明確指出，確實認為轉移跡象將在明年下半年及以後開始增加。所以，是的，如果你想想進入今年，decipher 的發展確實比我們預期的要好得多。我認為 NCCN 指南和商業付款人是營收成長如此強勁的主要原因。我們還沒有準備好提供明年的指南，因為我們仍在解決這個問題。但我們確實說過，當你同時考慮破解和確認時，我們對未來的測試成長感到非常樂觀，但沒有給出這個數字。我確實為明年的高個位數確認提供了一些指導，但尚未準備好在破解方面這樣做。

Okay. That's helpful and then, you know, recently, one of your, one of the peers saw commercial pressures from a large payer in pharmacogenomics, obviously, that's a different test than classifier test that you have for cancer. But can you just maybe elaborate on, on what you're seeing in the marketplace in terms of from commercial pairs? And what portion of your volume today is for Afirma and decipher are sort of contracted with the commercials and the level of stability here because the key question being that the pa to start looking for savings, you know, they might look to some diagnostic companies. Thank you.

好的。這很有幫助，然後，你知道，最近，你的一位同行看到了來自藥物基因組學大支付者的商業壓力，顯然，這是一種與癌症分類測試不同的測試。但是您能否詳細說明一下您在市場上看到的商業配對的情況？今天的 Afirma 和 decipher 銷售的一部分與廣告和這裡的穩定性水平有關，因為關鍵問題是 pa 開始尋求節省，你知道，他們可能會尋找一些診斷公司。謝謝。

Yeah, it's an excellent question. And I think, you know, there's a lot of differences there and if I understand it correctly, the way I read that decision was based on the lack of evidence that they perceived was, was available for those tests. And, you know, from our standpoint, decipher and fer have so much evidence, not just, you know, the evidence that perspective and real world that we have for both tests that, you know, studies that are ongoing, it's in guidelines as well in NCCN for Decipher. And so there's so much strength for both tests from an evidence standpoint. And in fact, we're having the opposite conversations which is bringing more payers into contracts to your question around the split. Think of decipher as roughly call it, you know, 60% ish Medicare. A Medicare advantage and then the rest is commercial and we've been adding commercial payers and I think we are over 200 million covered lives. Think of Affirmers as being more like a third Medicare. And so commercial is a much bigger proportion on the affirm side. And Affirmers has been 270 million lives or more for quite some time. And so we're not seeing any pullback from a commercial payers from, as I say, on the contrary, we're actually having some success with moving into contracting with more.

是的，這是一個很好的問題。我認為，你知道，那裡存在著許多差異，如果我理解正確的話，我閱讀該決定的方式是基於他們認為缺乏可用於這些測試的證據。而且，你知道，從我們的角度來看，decipher 和 fer 有很多證據，而不僅僅是我們對這兩項測試的觀點和現實世界的證據，你知道，正在進行的研究，它在指導方針中在NCCN 進行解密。因此，從證據的角度來看，這兩項測試都有很大的優勢。事實上，我們正​​在進行相反的對話，這讓更多的付款人就您關於拆分的問題簽訂了合約。你知道，Decipher 粗略地稱之為 60% 左右的醫療保險。醫療保險優勢，其餘的都是商業優勢，我們一直在增加商業付款人，我認為我們已經涵蓋了超過 2 億人的生命。將肯定者視為更像是第三種醫療保險。因此，商業在肯定方面所佔的比例要大得多。相當長一段時間以來，《肯定者宣言》已經影響了 2.7 億人甚至更多。因此，正如我所說，我們沒有看到商業付款人有任何退縮，相反，我們實際上在與更多人簽訂合約方面取得了一些成功。

Got it. That's helpful. Thank you guys.

知道了。這很有幫助。謝謝你們。

Thank you.

謝謝。

Our next question comes from Mason Carrico with Stephens Inc. Mason, Go ahead with your question.

我們的下一個問題來自 Stephens Inc. 的梅森·卡里科 (Mason Carrico)。

Hi, this is Ben on for Mason. Thanks for taking the questions today. Was hoping as it relates to your sales force. Could you help us understand where you see those teams growing over time? And then as you slowly add reps over time, can you remind us how long it typically takes for those reps to be fully productive really? By your standards?

大家好，我是梅森的本。感謝您今天提出問題。希望這與您的銷售人員有關。您能幫助我們了解您認為這些團隊隨著時間的推移在哪些方面成長嗎？然後，當您隨著時間的推移慢慢增加代表時，您能提醒我們這些代表通常需要多長時間才能真正完全發揮作用嗎？按照你的標準？

Yeah, great question. And let me take it in three categories. Decipher affirm. And then you take the decipher side. We've got roughly 50 reps same in affirm. And in both cases, I said we've added a handful of reps in the last year and I don't see that changing going forward. It's a much more gradual ad in terms of the sales team relative to the revenue and volume growth. And in our experience, you know, you have to be very thoughtful about dividing up territories, creating new territories, splitting territories, bringing on new reps. So, you have to plan that very carefully and our team does a great job of that to answer your question. I think it takes about six months really for a sales rep typically to get up to speed in their new territory and region. The fact that we haven't had a lot of turnover means we haven't had to do that much. But when we've added new reps, that's typically what we see. So, I think 66 months is a reasonable estimate. On the IVD side, it's a different matter. You're selling to labs in that case. And so, you know, we will be able to ramp country by country and bear in mind. We already have some sales teams, commercial teams in the country selling prosigna. But once we launch more menu, we'll be able to ramp country by country as we see, our tests become, you know, reimbursed in those countries. And so it's a very thoughtful gradual thing. It's not like you have to build a lot of commercial capability in the hope that the volume will come. it's actually you can, but in our business, you can pretty much, you know, put those two things together and grow the team as you see the revenue opportunity coming.

是的，很好的問題。讓我把它分為三類。破譯確認。然後你就採取破解的一面。我們已經得到了大約 50 次相同的確認。在這兩種情況下，我都說過我們在去年增加了一些代表，而且我認為這種情況未來不會改變。就銷售團隊而言，相對於收入和銷售的成長而言，這是一個更漸進的廣告。根據我們的經驗，你知道，你必須非常仔細地考慮分割領域、創造新領域、分割領域、引進新代表。因此，您必須非常仔細地計劃，我們的團隊在這方面做得很好，可以回答您的問題。我認為銷售代表通常需要大約六個月的時間來適應新的領域和地區。事實上，我們的人員流動率並不高，這意味著我們不必做那麼多事情。但當我們新增新的代表時，我們通常會看到這樣的情況。所以，我認為 66 個月是一個合理的估計。在 IVD 方面，則是另一回事。在這種情況下，你就賣給實驗室。因此，您知道，我們將能夠逐一推進並牢記這一點。我們已經有一些銷售團隊、商業團隊在國內銷售 Prosigna。但是，一旦我們推出更多菜單，我們將能夠逐個國家進行推廣，正如我們所見，我們的測試將在這些國家獲得報銷。所以這是一個非常深思熟慮的漸進的事情。這並不是說你必須建立大量的商業能力才能實現銷售。實際上你可以，但在我們的業務中，你知道，你幾乎可以將這兩件事放在一起，並在你看到收入機會到來時發展團隊。

Okay, great. Thank you. And then sort of diving into IVD. I was wondering if you'd be able to provide any update there on those products under development. Are there any timelines that we're sort of able to look towards in the future? Thank you again for taking the questions.

好的，太好了。謝謝。然後深入研究 IVD。我想知道您是否能夠提供有關正在開發的這些產品的任何更新。未來我們是否可以預見一些時間表？再次感謝您提出問題。

Yeah, no major update. I said earlier, we're developing several products during 2025. And so I think of that as a transition year Decipher, PCR and Prosigna NGS are the first ones that we expect to have ready for launch next year and then nasal swab following that. And so, you know that that's kind of the timelines we've talked about so far as I said, we're dealing with them on the Prosigna side, we're dealing with some challenges that's more on the encounter product, but we want to make sure that the supply chain is fully ready for PCR and NGS when we're ready to launch those tests as well.

是的，沒有重大更新。我之前說過，我們將在 2025 年開發多種產品。因此，我認為這是一個過渡年，Decipher、PCR 和 Prosigna NGS 是我們預計明年推出的首批產品，然後是鼻拭子。所以，你知道，這就是我們到目前為止所討論的時間表，我們正在 Prosigna 方面處理它們，我們正在處理一些更多關於遭遇產品的挑戰，但我們希望當我們準備好啟動這些測試時，確保供應鏈為PCR 和NGS 做好充分準備。

Okay.

好的。

This concludes the question and answer session. I would now like to turn it back to mark Stapley for closing remarks.

問答環節到此結束。現在我想轉回給斯塔普利做總結發言。

Thanks very much (Stacey). So I'm incredibly proud of our execution this quarter with our team delivering outstanding revenue growth of 34% and the adjusted EBITDA margin of 24%. As you can clearly see, we continue to have a best in class financial profile for a specialty diagnostics company and are closing in on our previously stated goal of achieving a sustainable 25% adjusted EBITDA margin annually.

非常感謝（史黛西）。因此，我對本季的執行力感到無比自豪，我們的團隊實現了 34% 的出色收入成長和 24% 的調整後 EBITDA 利潤率。正如您可以清楚地看到的，我們繼續擁有專業診斷公司一流的財務狀況，並且正在接近我們之前提出的每年實現 25% 調整後 EBITDA 利潤率的可持續目標。

Additionally, I want to take this opportunity to announce an important change to my leadership team. In that Keith Gogo has been promoted to SVP global Operations. Keith's deep expertise, managing our clear labs as VP clears for the last 18 months has enabled us to scale with our growing revenue and we're in an excellent position to meet our future demand. I look forward to his continued contributions as we further build out our organization for scale. I also want to take this opportunity to thank Rebecca for her outstanding leadership over our clear operations for the last two years. In addition to her Chief Financial Officer responsibilities. Finally, I want to again thank our incredible team of aigh for their tireless work to make a difference in the lives of the patients. We serve. We look forward to updating you all again on our 2024 performance and expectations for 2025 in the new year.

此外，我想藉此機會宣布我的領導團隊的一項重要變動。Keith Gogo 已晉升為全球營運資深副總裁。Keith 深厚的專業知識，在過去 18 個月裡以副總裁的身份管理我們的透明實驗室，使我們能夠隨著收入的增長而擴大規模，並且我們處於滿足未來需求的絕佳位置。我期待他在我們進一步擴大組織規模時繼續做出貢獻。我也想藉此機會感謝麗貝卡在過去兩年中對我們清晰營運的出色領導。除了首席財務官的職責外。最後，我想再次感謝我們令人難以置信的 aigh 團隊為改變患者的生活所做的不懈努力。我們服務。我們期待在新的一年再次向大家通報我們 2024 年的表現以及對 2025 年的期望。

Ladies and gentlemen, this concludes our call today. Thank you for joining us. You may now disconnect.

女士們、先生們，我們今天的通話到此結束。感謝您加入我們。您現在可以斷開連線。