Castle Biosciences Inc (CSTL) 2025 Q1 法說會逐字稿

Good afternoon, and welcome to Castle Biosciences first quarter 2025 conference call. As a reminder, today's call is being recorded. We will begin today's call with opening remarks and introductions, followed by a question-and-answer session.

下午好，歡迎參加 Castle Biosciences 2025 年第一季電話會議。提醒一下，今天的通話正在錄音。今天的電話會議我們將以開場白和介紹開始，然後是問答環節。

I would like to turn the call over to Camilla Zuckero, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

我想將電話轉給投資者關係和公司事務副總裁 Camilla Zuckero。請繼續。

Thank you, operator. Good afternoon, everyone. Welcome to Castle Biosciences first quarter 2025 results conference call. Joining me today are Castle's Founder, President and Chief Executive Officer, Derek Maetzold; Chief Financial Officer, Frank Stokes; and Senior Vice President, Medical, Dr. Matthew Goldberg, Board-certified dermatologist and dermatopathologist.

謝謝您，接線生。大家下午好。歡迎參加 Castle Biosciences 2025 年第一季業績電話會議。今天與我一起出席的還有 Castle 的創始人、總裁兼首席執行官 Derek Maetzold、首席財務官 Frank Stokes 以及醫療高級副總裁、委員會認證的皮膚科醫生和皮膚病理學家 Matthew Goldberg 博士。

Information recorded on this call speaks only as of today, May 5, 2025. Therefore, if you are listening to the replay or reading this transcript of this call, any time-sensitive information may no longer be accurate. A recording of today's call will be available on the Investor Relations page of the company's website for approximately three weeks following the conclusion of the call. Before we begin, I would like to remind you that some of the statements made today will contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

本次通話中記錄的資訊僅截至今天（2025 年 5 月 5 日）有效。因此，如果您正在收聽重播或閱讀此通話的記錄，任何時間敏感資訊可能不再準確。今天的電話會議錄音將在電話會議結束後約三週內在公司網站的投資者關係頁面上提供。在我們開始之前，我想提醒您，今天發表的一些聲明將包含 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。

These forward-looking statements include, but are not limited to, statements about our financial outlook, TAM, intended use populations and similar items referenced in our earnings release issued today and statements containing projections regarding future events or our future financial or operational results and performance, including our anticipated 2025 total revenue, our expectations regarding reimbursement for our products, opportunities for growth, impacts of seasonality and other trends, the size and structure of our commercial teams, the timing of targeted milestones and the impact of our investments in growth initiatives, including our ability to achieve long-term growth and drive stockholder value.

這些前瞻性陳述包括但不限於有關我們的財務前景、TAM、預期使用人群和今天發布的收益報告中提及的類似項目的陳述，以及包含有關未來事件或我們未來財務或營運結果和業績的預測的陳述，包括我們預計的 2025年總收入、我們對產品報銷的預期、成長機會、季節性和其他趨勢的影響、我們商業團隊的規模和結構、目標里程碑的時間以及我們對成長計畫的投資的影響，包括我們實現長期成長和推動股東價值的能力。

Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties, and there can be no assurances that the results contemplated in these statements will be realized. A number of factors and risks could cause actual results to differ materially from those contained in these forward-looking statements.

前瞻性陳述是基於當前預期，涉及固有風險和不確定性，並且不能保證這些陳述中預期的結果將會實現。許多因素和風險可能導致實際結果與這些前瞻性陳述中的結果有重大差異。

These factors and other risks and uncertainties are described in detail in the company's annual report on Form 10-K for the year ended December 31, 2024, and its quarterly report on Form 10-Q for the quarter ended March 31, 2025, under the heading Risk Factors and in the company's other documents and reports filed or to be filed with the Securities and Exchange Commission.

這些因素以及其他風險和不確定性在公司截至 2024 年 12 月 31 日的 10-K 表年度報告和截至 2025 年 3 月 31 日的 10-Q 表季度報告中的“風險因素”標題下有詳細描述，並在公司向美國證券交易委員會提交或將要提交的其他文件和報告中有詳細描述。

These forward-looking statements speak only as of today, and we assume no obligation to update or revise these forward-looking statements as circumstances change. In addition, some of the information discussed today includes non-GAAP financial measures such as adjusted revenue, adjusted gross margin, adjusted net loss per share, basic and diluted and adjusted EBITDA that have not been calculated in accordance with generally accepted accounting principles in the United States or GAAP.

這些前瞻性陳述僅代表今天的觀點，我們不承擔隨著情況變化而更新或修改這些前瞻性陳述的義務。此外，今天討論的一些資訊包括非 GAAP 財務指標，例如調整後收入、調整後毛利率、調整後每股淨虧損、基本和稀釋以及調整後 EBITDA，這些指標尚未按照美國公認會計原則或 GAAP 計算。

These non-GAAP items should be used in addition to and not as a substitute for any GAAP results. We believe these metrics provide useful supplemental information in assessing our revenue and operating performance. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the Investor Relations page of the company's website.

這些非 GAAP 項目應作為任何 GAAP 結果的補充而非替代。我們相信這些指標為評估我們的收入和營運績效提供了有用的補充資訊。這些非 GAAP 財務指標與最直接可比較的 GAAP 財務指標的對帳情況已列在我們今天早些時候發布的收益報告末尾的表格中，該報告已發佈在公司網站的投資者關係頁面上。

I will now turn the call over to Derek.

現在我將把電話轉給德里克。

Thank you, Camilla, and good afternoon, everyone. We are off to an exceptional start of the year, building on our track record of consistent execution and strong business fundamentals. Revenue grew by 21% to $88 million and total test report volume for our core revenue drivers grew by 33% compared to the first quarter of 2024.

謝謝你，卡米拉，大家下午好。憑藉一貫的執行力和強大的業務基礎，我們迎來了非凡的開年。與 2024 年第一季相比，營收成長 21%，達到 8,800 萬美元，核心營收驅動因素的總測試報告量成長了 33%。

Additionally, we believe our strong balance sheet with $275 million in cash, cash equivalents and marketable investment securities gives us the flexibility to continue executing on our growth initiatives as we work to maintain financial discipline. This includes strategic opportunities as evidenced by our announcement earlier today that we signed a definitive agreement to acquire Previse, which we believe can further benefit patients and providers alike, while strengthening our position in the gastrointestinal space.

此外，我們相信，我們強勁的資產負債表（2.75億美元現金、現金等價物和有價投資證券）使我們能夠靈活地繼續執行我們的成長計劃，同時努力保持財務紀律。這包括策略機遇，正如我們今天早些時候宣布的那樣，我們簽署了收購 Previse 的最終協議，我們相信這可以進一步使患者和提供者受益，同時加強我們在胃腸道領域的地位。

Today, I will walk you through business highlights from the quarter, discuss our expected acquisition of Previse, and then Frank will provide additional financial highlights before we turn to your questions. Before diving into our business highlights, I'd like to introduce Dr. Matthew Goldberg.

今天，我將向您介紹本季的業務亮點，討論我們預期的對 Previse 的收購，然後 Frank 將在回答您的問題之前提供更多財務亮點。在深入介紹我們的業務亮點之前，我想介紹一下馬修·戈德堡博士。

Matt joined Castle in August 2020 and currently serves as our Senior Vice President, Medical. He completed his dermatology residency at the University of California, San Francisco, followed by Dermatopathology Fellowship at the University of Texas, Southwestern. Board certified in both dermatology and in dermatopathology, Dr. Goldberg is the ideal person to discuss our DecisionDx-Melanoma test as we enter May, skin cancer awareness month.

Matt 於 2020 年 8 月加入 Castle，目前擔任醫療高級副總裁。他在加州大學舊金山分校完成了皮膚病學住院實習，隨後在德州大學西南分校完成了皮膚病理學研究。戈德堡博士是皮膚病學和皮膚病理學的委員會認證專家，在我們進入五月皮膚癌宣傳月之際，他是討論我們的 DecisionDx-Melanoma 測試的理想人選。

Matt?

馬特？

Thank you, Derek. May is skin cancer awareness month. Our mission aligns with raising awareness about the importance of prevention, early detection, risk assessment and personalized treatment strategies designed to improve patient outcomes including for one of the most aggressive forms of skin cancer melanoma.

謝謝你，德里克。五月是皮膚癌宣導月。我們的使命是提高人們對預防、早期發現、風險評估和個人化治療策略重要性的認識，旨在改善患者的治療效果，包括針對最具侵襲性的皮膚癌之一黑色素瘤的治療效果。

As you think about the patient journey, our DecisionDx-Melanoma test is ordered by physicians after biopsies take place and a diagnosis of invasive melanoma is made. And our test is designed to answer two important clinical questions to guide subsequent treatment plan decisions at this point in the patient journey.

當您考慮患者的治療過程時，我們的 DecisionDx-Melanoma 測試是在進行活檢並做出侵襲性黑色素瘤的診斷後由醫生下令進行的。我們的測試旨在回答兩個重要的臨床問題，以指導患者在治療過程中的後續治療計劃決策。

First, what is the risk of sentinel lymph node positivity in order to inform decisions on the sentinel lymph node biopsy procedure. And second, what is the patient's risk of recurrence? And importantly, DecisionDx-Melanoma has been shown to be associated with improved patient survival as evidenced from real-world prospective data.

首先，為了指導前哨淋巴結活檢程序的決策，前哨淋巴結陽性的風險是多少。其次，患者復發的風險是多少？重要的是，現實世界的前瞻性數據已證明 DecisionDx-Melanoma 與患者存活率的提高有關。

Therefore, I'm especially pleased DecisionDx-Melanoma recently achieved a significant milestone, surpassing 200,000 test orders since we launched the test. This is a remarkable achievement, and I'm extremely proud of my colleagues and their unwavering commitment to improving the lives of the patients we serve.

因此，我特別高興 DecisionDx-Melanoma 最近取得了一個重要的里程碑，自從我們推出測試以來，測試訂單已超過 200,000 個。這是一項了不起的成就，我為我的同事以及他們為改善我們所服務的患者的生活所做的不懈努力感到無比自豪。

With that, I'll turn it back to Derek.

說完這些，我就把它交還給德瑞克。

Thanks, Matt. Now we will discuss our quarterly highlights. For DecisionDx-Melanoma, we delivered 8,621 test reports in the quarter, an increase of 3% compared to the first quarter of 2024 and roughly flat from the fourth quarter of 2024 as expected. As a reminder, historically, the second quarter sees growth sequentially over the first quarter. Importantly, we anticipate high single-digit volume growth for DecisionDx-Melanoma for the full year 2025 compared to 2024.

謝謝，馬特。現在我們將討論我們的季度亮點。對於 DecisionDx-Melanoma，我們在本季交付了 8,621 份測試報告，與 2024 年第一季相比成長了 3%，與 2024 年第四季基本持平，符合預期。提醒一下，從歷史上看，第二季的成長速度會比第一季加快。重要的是，我們預計與 2024 年相比，2025 年全年 DecisionDx-Melanoma 的銷量將實現高個位數成長。

We believe our compelling body of evidence reinforces continued adoption. We are especially pleased with the recent publication of two papers discussing data from a prospective multicenter study, demonstrating the significant impact of our DecisionDx-Melanoma test on sentinel lymph node biopsy or SLMB decision-making.

我們相信，我們令人信服的證據將加強我們繼續採用的力度。我們尤其高興看到最近發表的兩篇論文討論了一項前瞻性多中心研究的數據，證明了我們的 DecisionDx-Melanoma 測試對前哨淋巴結活檢或 SLMB 決策的重大影響。

The first publication reported data from our DECIDE study, supporting the performance of a low-risk DecisionDx-Melanoma test result to predict sentinel lymph node positivity rates of less than 5% who have elected to have an SLNB. In this prospective multicenter study, no patient with a DecisionDx-Melanoma predicted risk of less than 5% SLN positivity, but who decided to have an SLNB procedure anyways had a positive node. That is the actual SLNB positivity rate was 0%.

第一篇出版物報告了我們 DECIDE 研究的數據，支持使用低風險 DecisionDx-Melanoma 測試結果來預測選擇進行 SLNB 的患者的前哨淋巴結陽性率低於 5%。在這項前瞻性多中心研究中，沒有一位患有 DecisionDx-Melanoma 的患者預測 SLN 陽性風險低於 5%，但決定進行 SLNB 手術的患者出現陽性淋巴結。也就是說實際的 SLNB 陽性率為 0%。

The second publication shared outcomes of patients with a low-risk DecisionDx-Melanoma test result, of which approximately half the patients decided to forego an SLNB and approximately half proceeded with an SLNB despite the low-risk DecisionDx-Melanoma test result.

第二篇出版物分享了 DecisionDx-Melanoma 檢測結果為低風險的患者的結果，其中大約一半的患者決定放棄 SLNB，而大約一半的患者儘管 DecisionDx-Melanoma 檢測結果為低風險，但仍繼續進行 SLNB。

Of clinical significance, all patients with a low-risk DecisionDx-Melanoma test result were recurrence-free. Specifically, we saw a 100% recurrence-free survival rate with a median follow-up of two years. Additionally, during the quarter, we presented new study data at the National Comprehensive Cancer Network, or NCCN, 2025 Annual Conference, showing DecisionDx-Melanoma as a significant predictor of mortality in a real-world cohort of nearly 7,000 patients with early-stage cutaneous melanoma.

具有臨床意義的是，所有 DecisionDx-Melanoma 檢測結果為低風險的患者均無復發。具體來說，我們發現無復發生存率達到 100%，平均追蹤時間為兩年。此外，在本季度，我們在美國國家綜合癌症網絡 (NCCN) 2025 年年會上展示了新的研究數據，表明 DecisionDx-Melanoma 是現實世界中近 7,000 名早期皮膚黑色素瘤患者死亡率的重要預測指標。

Specifically, as part of Castle's collaboration with the National Cancer Institute's SEER program, this study further validated DecisionDx-Melanoma's risk stratification performance in patients with thin or early-stage cutaneous melanoma tumors or Stage 1 to 2a.

具體而言，作為 Castle 與美國國家癌症研究所 SEER 計畫合作的一部分，該研究進一步驗證了 DecisionDx-Melanoma 在薄型或早期皮膚黑色素瘤或 1 至 2a 期患者中的風險分層性能。

In a real-world cohort of 6,892, eighth edition of the American Joint Committee on Cancer, or AJCC8 low-risk patients, the test identified individuals at higher risk of death. Importantly, multivariable analyses confirmed DecisionDx-Melanoma as a significant predictor of melanoma-specific mortality and overall mortality, independent of key AJCC8 factors.

在現實世界中，美國癌症聯合委員會第八版（AJCC8）的 6,892 名低風險患者中，該測試識別出了死亡風險較高的個體。重要的是，多變量分析證實 DecisionDx-Melanoma 是黑色素瘤特異性死亡率和總體死亡率的重要預測指標，與關鍵的 AJCC8 因素無關。

These findings highlight the test ability to refine risk assessment beyond AJCC8 staging, helping identify patients who may benefit from enhanced surveillance and management to potentially improve outcomes. Moving on to our DecisionDx-SCC test. We delivered 4,375 test reports in the first quarter of 2025.

這些發現凸顯了測試在 AJCC8 分期之外改善風險評估的能力，有助於識別可能受益於加強監測和管理以潛在改善結果的患者。繼續我們的 DecisionDx-SCC 測試。我們在 2025 年第一季提交了 4,375 份測試報告。

Building on our six studies published in 2024, we presented new data at the NCCN 2025 Annual Conference, demonstrating DecisionDx-SCC's ability to enhance risk stratification beyond traditional staging. Specifically, the study evaluated how integrating DecisionDx-SCC with the Brigham and Women's Hospital or BWH staging, under NCCN guidelines may improve prognostic accuracy.

在我們 2024 年發表的六項研究的基礎上，我們在 NCCN 2025 年年會上展示了新數據，證明了 DecisionDx-SCC 能夠超越傳統分期來增強風險分層。具體而言，該研究評估了在 NCCN 指南下將 DecisionDx-SCC 與布萊根婦女醫院或 BWH 分期相結合如何提高預後準確性。

In a multicenter cohort of 1,412 high-risk SCC patients, DecisionDx-SCC significantly enhanced metastatic risk stratification in NCCN high-risk and very high-risk patient populations. And the data demonstrated that the test improved BWH's staging risk prediction accuracy.

在 1,412 名高風險 SCC 患者的多中心群組中，DecisionDx-SCC 顯著增強了 NCCN 高風險和極高風險患者群體的轉移性風險分層。數據表明，該測試提高了 BWH 分期風險預測的準確性。

When combined with BWH staging, a DecisionDx-SCC Class I test result, which is considered low risk results in a nearly twofold decrease in metastatic risk, while a Class IIb test result, which is the highest risk reported, showed more than a fivefold increase in risk among lower-stage patients classified as BWHT1 or T2A NCC and high-risk patients.

與 BWH 分期相結合，DecisionDx-SCC I 類測試結果（被認為風險較低）導致轉移風險降低近兩倍，而 IIb 類測試結果（報告的風險最高）顯示，在歸類為 BWHT1 或 T2A NCC 的較低階段患者和高風險患者中，風險增加了五倍以上。

These findings demonstrate that DecisionDx-SCC may refine individual patient risk assessment, supporting more accurate, personalized treatment decisions based upon a patient's predictive metastatic risk. Now let's turn to DecisionDx-SCC reimbursement. The Novitas Local Coverage Determination policy, or LCD, that included noncoverage language for DecisionDx-SCC went into effect on April 24, 2025.

這些發現表明，DecisionDx-SCC 可以改善個別患者風險評估，支持根據患者的預測轉移風險做出更準確、個人化的治療決策。現在讓我們來談談 DecisionDx-SCC 報銷。Novitas 本地覆蓋範圍確定政策（LCD）包含 DecisionDx-SCC 的非覆蓋範圍語言，於 2025 年 4 月 24 日生效。

We will be pursuing reconsideration requests of both the Novitas and MolDX LCDs. Based upon timing, neither these LCDs included a review of the six 2024 publications noted above, which included evidence showing that DecisionDx-SCC is able to predict response to adjuvant radiation therapy, or ART, in addition to predicting the risk of progression.

我們將對 Novitas 和 MolDX LCD 進行重新審議請求。根據時間安排，這兩個 LCD 均未包括對上述六份 2024 年出版物的審查，這些出版物包括的證據表明 DecisionDx-SCC 除了能夠預測進展風險外，還能夠預測對輔助放射治療或 ART 的反應。

Given the strength of evidence of the data surrounding this use, we believe the reconsideration request could be accepted as valid. This evidence and additional studies support that the test is reasonable and necessary, which is the CMS requirement to be a covered test for patients with high-risk SCC.

鑑於圍繞此用途的數據證據的力度，我們認為重新考慮請求可以被接受為有效的。該證據和其他研究證明該測試是合理且必要的，這是 CMS 對高風險 SCC 患者的覆蓋測試的要求。

For now, we will be continuing to offer the test because given the strength of evidence in DecisionDx-SCC's ability to predict both the risk of metastasis to impact treatment pathway decisions and the ability to predict responsiveness to ART, we believe it is the right thing to do for patient care.

目前，我們將繼續提供該測試，因為鑑於 DecisionDx-SCC 能夠預測轉移風險以影響治療途徑決策以及預測對 ART 的反應能力的證據強度，我們相信這對患者護理來說是正確的做法。

Now let's turn to our gastroenterology franchise. Before getting into our TissueCypher performance for the quarter and the expected Previse acquisition, I want to highlight that April was esophageal cancer awareness month, a month dedicated to raising awareness about esophageal cancer, its risk factors and the importance of early detection.

現在讓我們來談談胃腸病學特許經營。在介紹本季的 TissueCypher 業績和預期的 Previse 收購之前，我想強調一下，四月是食道癌宣傳月，這個月致力於提高人們對食道癌、其風險因素以及早期發現的重要性的認識。

Supporting key educational programs and initiatives throughout the month of April, Castle proudly collaborated with the Esophageal Cancer Action Network, the American Foregut Society and The Gut Doctor Podcast to promote esophageal cancer prevention, education and advocacy.

在整個四月份，Castle 支持重要的教育計劃和舉措，並自豪地與食道癌行動網絡、美國前腸協會和腸道醫生播客合作，促進食道癌的預防、教育和宣傳。

As you will recall, we acquired TissueCypher in December 2021, giving us our spatialomics test designed to determine a patient's individual risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal cancer. Barrett's esophagus is the only known risk factor for the development of esophageal adenocarcinoma cancer, one of the fastest-growing cancers in the US with a five year survival rate of less than 20%.

您可能還記得，我們​​在 2021 年 12 月收購了 TissueCypher，從而為我們提供空間組學測試，旨在確定患者從巴雷特食道進展為高級別發育不良或食道癌的個體風險。巴雷特食道是已知的唯一導致食道腺癌的風險因素，食道腺癌是美國成長最快的癌症之一，五年存活率不到 20%。

TissueCypher have been studied in 16 peer-reviewed publications to date and studies have consistently found that TissueCypher is the strongest independent predictor of progression with the ability to help identify non-dysplastic patients that progress at a rate similar to confirmed low-grade dysplasia.

迄今為止，已有 16 篇同行評審出版物對 TissueCypher 進行了研究，研究一致發現，TissueCypher 是進展的最強獨立預測指標，能夠幫助識別進展速度與確診的低度發育不良相似的非發育不良患者。

For this reason, we are thrilled with the positive reception TissueCypher has received from the gastroenterology community, particularly as the test can make a meaningful impact on patient care in an area with unmet clinical needs. In fact, in the first quarter of 2025, we delivered 7,432 TissueCypher test reports compared to 3,429 in the same period of 2024.

因此，我們對 TissueCypher 在胃腸病學界獲得的積極反響感到非常高興，特別是因為該測試可以對未滿足臨床需求領域的患者護理產生有意義的影響。事實上，2025 年第一季度，我們提交了 7,432 份 TissueCypher 測試報告，而 2024 年同期為 3,429 份。

This represents 117% year-over-year growth compared to the first quarter of 2024. As a reminder, the growth drivers we expect for TissueCypher in 2025 and beyond include: one, our recent commercial team expansion; two, the unmet clinical need and clinical value of our test being further accepted by clinicians; and three, a strong focus on education and awareness.

與 2024 年第一季相比，這一數字年增 117%。提醒一下，我們預期 TissueCypher 在 2025 年及以後的成長動力包括：一、我們最近的商業團隊擴張；二、我們測試的未滿足的臨床需求和臨床價值得到臨床醫生的進一步認可；三、高度重視教育和意識。

We're excited about the growth prospects of the test, including the volume growth expected in 2025, and we are equally pleased by its clinical utility to determine a patient's individual risk of progression from Barrett's esophagus disease to cancer.

我們對該測試的成長前景感到興奮，包括預計 2025 年的量增長，我們同樣對其臨床實用性感到高興，因為它可以確定患者從巴雷特食道疾病發展為癌症的個體風險。

Turning to our announcement from earlier today, we recently signed a definitive agreement to acquire Previse, a gastrointestinal health company with a primary focus on esophageal disorders. We believe this proposed transaction underscores our commitment to the GI community providers and patients alike.

回顧我們今天早些時候發布的公告，我們最近簽署了一項最終協議，收購 Previse，一家主要關注食道疾病的胃腸道健康公司。我們相信，這項擬議的交易強調了我們對胃腸道社區提供者和患者的承諾。

As part of our strategic growth initiatives, we continually assess opportunities for ones that would fit into most or all of our outline criteria, which are complementary to our existing test disease states, adding value for our current customers, some level of existing reimbursement and a test that could be successful utilizing Castle's commercial playbook.

作為我們策略成長計畫的一部分，我們不斷評估符合我們大部分或全部概要標準的機會，這些機會與我們現有的測試疾病狀態相補充，為我們現有的客戶增加價值，一定程度的現有報銷以及可以利用 Castle 的商業劇本取得成功的測試。

With Previse, we found an opportunity to expand our offerings within our GI vertical beyond our spatialomics TissueCypher Barrett's Esophagus test, furthering our position in this space. Previse's methylation technology, as well as its pipeline technology provides us with the potential to address existing unmet needs, including potential upstream opportunities.

借助 Previse，我們發現了一個機會，可以在空間組學 TissueCypher Barrett 食道測試之外擴展我們在胃腸道垂直領域的產品，從而進一步鞏固我們在該領域的地位。Previse 的甲基化技術及其管道技術為我們提供了解決現有未滿足需求的潛力，包括潛在的上游機會。

We expect the transaction to close in a matter of weeks, and we'll continue to work through technology transfer, integration and future R&D plans. Turning to our mental health business. As we told you on our last earnings call in February, due to changes in the market and our focus on allocating resources efficiently on profitable growth.

我們預計交易將在幾週內完成，我們將繼續致力於技術轉移、整合和未來的研發計劃。談談我們的心理健康業務。正如我們在二月的上次收益電話會議上所說的那樣，由於市場的變化以及我們對有效分配資源以實現盈利增長的關注。

In late 2024, we revised our commercial strategy for our IDgenetix test, reallocating resources to inside sales and non-personal promotions. After careful further assessment, we made the decision to discontinue the test effective May 2025, as it makes the best sense for our business to put its resources towards other disease states with unmet clinical needs.

2024 年末，我們修改了 IDgenetix 測試的商業策略，將資源重新分配給內部銷售和非個人促銷。經過仔細的進一步評估，我們決定自 2025 年 5 月起停止測試，因為對於我們的業務來說，將資源投入到其他未滿足臨床需求的疾病狀態是最合理的。

And with that, I will now turn the call over to Frank.

現在，我將把電話轉給弗蘭克。

Thank you, Derek, and good afternoon, everyone. As Derek highlighted, we delivered very good first quarter financial results. Revenue was $88 million for the first quarter of 2025, an increase of 21% over the first quarter of 2024. The increase was driven predominantly by test volume growth for our non-dermatologic test, that is 117% TissueCypher growth compared to the first quarter of 2024.

謝謝你，德里克，大家下午好。正如德里克所強調的，我們第一季的財務表現非常好。2025 年第一季營收為 8,800 萬美元，比 2024 年第一季成長 21%。這一增長主要得益於我們非皮膚病學測試的測試量增長，與 2024 年第一季相比，TissueCypher 增長了 117%。

Adjusted revenue, which excludes the effects of revenue adjustments in the current period related to tests delivered in prior periods, was $87.2 million for the first quarter of 2025, an increase of 22% over the first quarter of 2024.

調整後收入（不包括與前期進行的測試相關的本期收入調整的影響）2025 年第一季為 8,720 萬美元，比 2024 年第一季成長 22%。

The total revenue for 2025, we are raising our revenue guidance to $287 million to $297 million, up from the previously provided range of $280 million to $295 million. Our revenue guide reflects DecisionDx-SCC reimbursement by Medicare through April 24th only. From apples-to-apples comparison for 2025 revenue growth, if you exclude DecisionDx-SCC revenue for both our 2024 and 2025 totals, our normalized revenue growth in 2025 would be high teens to low 20s percent.

對於 2025 年的總收入，我們將營收預期從先前提供的 2.8 億美元至 2.95 億美元上調至 2.87 億美元至 2.97 億美元。我們的收入指南僅反映了截至 4 月 24 日的 Medicare 的 DecisionDx-SCC 報銷情況。從 2025 年收入成長的同類比較來看，如果將 DecisionDx-SCC 的收入從我們的 2024 年和 2025 年總額中排除，那麼我們 2025 年的標準化收入增長率將達到百分之十幾到二十幾。

Our gross margin during the first quarter of 2025 was 49.2% compared to 77.9% in the first quarter of 2024. Our adjusted gross margin, which excludes the effects of intangible asset amortization related to our acquisitions and excludes the effects of revenue adjustments in the current period associated with test reports delivered in prior periods, was 81.2% for the quarter compared to 80.5% for the same period in 2024.

2025 年第一季我們的毛利率為 49.2%，而 2024 年第一季為 77.9%。我們的調整後毛利率（不包括與我們的收購相關的無形資產攤銷的影響，也不包括與前期交付的測試報告相關的當期收入調整的影響）為本季度 81.2%，而 2024 年同期為 80.5%。

The gross margin for the first quarter of 2025 was impacted in large part due to the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million during the three months ended March 31, 2025, associated with the discontinuation of IDgenetix that Derek mentioned earlier.

2025 年第一季的毛利率受到影響，很大程度上是由於 Derek 之前提到的 IDgenetix 停產導致在截至 2025 年 3 月 31 日的三個月內一次性調整了約 2010 萬美元的加速攤銷費用。

For each of the remaining quarters of 2025, we expect gross margin to be in the mid-70's range. Turning to expenses. Our total operating expenses, including cost of sales for the first quarter of 2025 were $115.9 million compared to $78.4 million for the first quarter of 2024. Sales and marketing expense for the quarter were $36.8 million compared to $30.5 million for the same period in 2024.

對於 2025 年剩餘的每個季度，我們預計毛利率將在 70% 左右。談到費用。我們的總營運費用（包括 2025 年第一季的銷售成本）為 1.159 億美元，而 2024 年第一季為 7,840 萬美元。本季銷售和行銷費用為 3,680 萬美元，而 2024 年同期為 3,050 萬美元。

The increase is mainly due to higher personnel costs, higher organizational and business development activities costs and higher sales-related travel and other expenses. General and administrative expenses were $21.8 million for the quarter compared to $18 million for the same period in 2024.

成長的主要原因是人事成本增加、組織和業務發展活動成本增加以及銷售相關差旅和其他費用增加。本季的一般及行政開支為 2,180 萬美元，而 2024 年同期為 1,800 萬美元。

The increase is primarily attributable to higher personnel costs, higher information technology-related costs and higher professional fees. Higher personnel costs reflects headcount expansions in our administrative support functions, as well as merit and annual inflationary wage adjustment for existing employees.

成長的主要原因是人員成本、資訊科技相關成本和專業費用的增加。人員成本的增加反映了我們行政支援職能部門的員工人數擴大，以及現有員工的績效薪資和年度通膨工資調整。

Cost of sales expenses were $16.4 million in the first quarter of 2025 compared to $13.9 million in the first quarter of 2024, primarily due to higher personnel costs, higher depreciation expense for lab equipment and leasehold improvements and higher lab services costs.

2025 年第一季的銷售費用為 1,640 萬美元，而 2024 年第一季為 1,390 萬美元，這主要是由於人員成本增加、實驗室設備和租賃改良的折舊費用增加以及實驗室服務成本增加。

Increases in personnel costs reflect a higher headcount due to additions made to support business growth in response to growing test report volumes, as well as merit and annual inflationary wage adjustments for existing employees. Higher expense for lab services also reflects higher test report volumes.

人事成本的增加反映了員工數量的增加，因為為了應對不斷增長的測試報告量以及現有員工的績效工資和年度通膨工資調整，需要增加員工來支持業務成長。實驗室服務費用的增加也反映了測試報告數量的增加。

R&D expenses were $12.6 million for the quarter compared to $13.8 million for the same period in 2024, primarily due to slightly lower personnel cost and expense for clinical studies. Total noncash stock-based compensation expense, which is allocated among cost of sales, R&D expense and SG&A expense was $11.2 million for the first quarter of 2025, down slightly from $12.7 million in the first quarter of 2024, despite a 23% year-over-year increase in total headcount.

本季研發費用為 1,260 萬美元，而 2024 年同期為 1,380 萬美元，主要原因是人員成本和臨床研究費用略有下降。2025 年第一季度，總非現金股票薪酬費用（分配在銷售成本、研發費用和銷售、一般及行政費用中）為 1,120 萬美元，略低於 2024 年第一季的 1,270 萬美元，儘管總員工人數同比增長 23%。

Interest income was $3.1 million for the first quarter of 2025 compared to $3 million in the first quarter of 2024, primarily a result of higher average balances of marketable investment securities and slightly higher interest rates.

2025 年第一季的利息收入為 310 萬美元，而 2024 年第一季的利息收入為 300 萬美元，這主要是由於有價投資證券的平均餘額較高且利率略有上升。

Our net loss for the first quarter 2025 was $25.8 million compared to $2.5 million for the first quarter of 2024 and net loss per share basic and diluted was $0.90 and adjusted net loss per share basic and diluted was $0.20 compared to $0.09 and $0.09 respectively, for the same period in 2024.

我們 2025 年第一季的淨虧損為 2,580 萬美元，而 2024 年第一季為 250 萬美元，基本和稀釋每股淨虧損為 0.90 美元，調整後每股基本和稀釋淨虧損為 0.20 美元，而 2024 年同期分別為 0.09 美元和 0.09 美元。

Adjusted EBITDA for the first quarter was $13 million compared to $10.5 million for the comparable period in 2024. Net cash used in operating activities was $6 million for the first quarter 2025, due in part to annual cash bonus payments and certain healthcare benefit payments that do not recur in the remaining three quarters of the year.

第一季調整後 EBITDA 為 1,300 萬美元，而 2024 年同期為 1,050 萬美元。2025 年第一季經營活動所用淨現金為 600 萬美元，部分原因是年度現金獎金支付和某些醫療福利支付在當年剩餘三個季度不會再次發生。

We continue to expect to deliver positive net cash flow from operations for the full year 2025. Net cash used in investing activities was $22.4 million for the first quarter and consisted primarily of purchases of marketable investment securities of $48.4 million, purchases of debt securities classified as held to market of $5.6 million and purchases of property and equipment of $4.7 million, partially offset by the maturity of marketable investment securities of $36.3 million.

我們繼續預計 2025 年全年經營淨現金流將為正值。第一季投資活動所用淨現金為 2,240 萬美元，主要包括購買有價投資證券 4,840 萬美元、購買分類為持有待售的債務證券 560 萬美元以及購買財產和設備 470 萬美元，部分被到期的有價投資證券 3,630 萬美元所抵銷。

As of March 31, 2025, we had cash, cash equivalents and marketable securities of $275.2 million. In conclusion, I'm pleased with our strong execution and results in the first quarter and look forward to maintaining that momentum for the rest of 2025.

截至 2025 年 3 月 31 日，我們擁有現金、現金等價物及有價證券 2.752 億美元。總而言之，我對我們第一季的強勁執行力和業績感到滿意，並期待在 2025 年剩餘時間內保持這一勢頭。

I'll now turn the call back over to Derek.

我現在將電話轉回給德里克。

Thank you, Frank. In summary, we had an excellent start to the year, building on our strength and momentum from 2024, underpinned by robust business fundamentals. We look forward to continuing to work to achieve the goals we set for 2025 as our focus remains on driving both near and long-term stockholder value. Thank you for your continued interest in Castle.

謝謝你，弗蘭克。總而言之，我們今年有一個良好的開端，以 2024 年的實力和勢頭為基礎，並以強勁的業務基本面為支撐。我們期待繼續努力實現我們為 2025 年設定的目標，因為我們的重點仍然是推動近期和長期股東價值。感謝您對 Castle 的持續關注。

We will now be happy to take your questions. Operator?

我們現在很樂意回答您的問題。操作員？

(Operator Instructions) Sung Ji Nam, Scotiabank.

（操作員指示）豐業銀行 Sung Ji Nam。

Hey, thanks for taking my question. Just, Frank, just a clarification, the mid-70% gross margin guidance, is that GAAP or non-GAAP? And also, does that include DecisionDx SCC contribution or impact?

嘿，謝謝你回答我的問題。弗蘭克，我只是需要澄清一下，70%左右的毛利率指導是按照 GAAP 計算的還是非 GAAP 計算的？而且，這是否包括 DecisionDx SCC 的貢獻或影響？

That's adjusted gross margin, Sung Ji and it does include the fall-off of reimbursement for SCC.

這是調整後的毛利率，Sung Ji，它確實包括了 SCC 報銷額的下降。

Okay. Got it. And then just on Previse, sorry, just didn't have a chance to go through their website carefully. But do they offer the methylation technology they offer, is that mostly tissue-based? Do they offer liquid biopsy-based technology as well?

好的。知道了。然後就 Previse 而言，抱歉，只是沒有機會仔細瀏覽他們的網站。但是他們是否提供甲基化技術，主要是基於組織的嗎？他們也提供基於液體活檢的技術嗎？

And then do you anticipate immediate contribution in terms of sales from this acquisition? Or is it just largely complementary in terms of providing additional insight to your TissueCypher product?

那麼，您是否預期此次收購會對銷售產生直接的貢獻？或者它只是在為您的 TissueCypher 產品提供額外見解方面具有很大的補充作用？

So they have a, hi, Sung ji, they have a product that is available commercially today that is tissue based. So it's similar to TissueCypher, but it uses a methylation platform or technology platform. They also have a non-endoscopic sponge-based technology.

所以他們有一個，嗨，Sung ji，他們有一種目前可在市場上買到的基於紙巾的產品。因此它與 TissueCypher 類似，但它使用甲基化平台或技術平台。他們還擁有非內視鏡海綿技術。

And from our perspective, we look forward to seeing if we could potentially combine both methodologies going forward into both tissue-based testing, as well as non-endoscopic or non-pinch biopsy tissue specimens. As, we have indicated in the last several quarters, we've been looking for other opportunities, both in dermatology and in gastroenterology to complement our current offerings and build the strength of both of those franchises.

從我們的角度來看，我們期待看到是否有可能將這兩種方法結合起來，用於基於組織的測試以及非內視鏡或非夾取活檢組織標本。正如我們在過去幾個季度所指出的，我們一直在尋找皮膚病學和胃腸病學領域的其他機會，以補充我們目前的服務並增強這兩個特許經營權的實力。

Previse happens to be one of the opportunities that we were able to pull the trigger on at this point in time, but there are other ones out there that we will hopefully be able to discuss in the future. And regarding sales contribution.

Previse 恰好是我們目前能夠抓住的機會之一，但還有其他機會，我們希望將來能夠討論。以及關於銷售貢獻。

And Sung ji, we wouldn't expect a meaningful impact on revenue or EBITDA this year, but those impacts will be more downstream.

Sung ji，我們預計今年的營收或 EBITDA 不會受到重大影響，但這些影響將更加顯著。

Got it. Appreviate it. Thank you.

知道了。很感激。謝謝。

Kyle Mikson, Canaccord Genuity.

凱爾米克森（Kyle Mikson），Canaccord Genuity。

Hey guys, thanks for taking my question. Congrats on the quarter and the acquisition. So just on Previse, maybe just walk through, Derek, where esophagus fits in the Barrett's workflow relative to TissueCypher. Just wondering if they compete at all? And then could you also talk about the test Medicare payment rate, the mix and the annual volume if possible?

嘿夥計們，謝謝你們回答我的問題。恭喜本季和此次收購。因此，就在 Previse 上，也許只是走一走，Derek，食道相對於 TissueCypher 適合 Barrett 的工作流程。只是想知道他們是否有競爭？然後，如果可能的話，您能否談談測試醫療保險支付率、組合和年度金額？

So the Previse test eso predict is a methylation-based assay. The current use is for predicting progression of Barrett's Esophagus disease, so similar to Castle's test of TissueCypher, the TissueCypher data set is more robust. Our interest is to see, one, how can this enhance our TissueCypher franchise?

因此，Previse 測試 eso predict 是一種基於甲基化的檢測。目前的用途是預測巴雷特食道疾病的進展，因此與 Castle 的 TissueCypher 測試類似，TissueCypher 數據集更加穩健。我們感興趣的是看，第一，這如何增強我們的 TissueCypher 特許經營權？

Can the combination reporting of both TissueCypher from a spatialomic standpoint and DNA methylation from a Previse standpoint get us to a stronger clinical offering to our patients today and tomorrow. And then, of course, can we also use the non-endoscopic sponge-based technology to really push forward a little more upstream Castle offerings.

從空間組學角度對 TissueCypher 進行報告，從 Previse 角度對 DNA 甲基化進行報告，能否讓我們現在和將來為患者提供更強大的臨床服務。當然，我們也可以使用非內視鏡海綿技術來真正推動 Castle 的上游產品發展。

Got it. That's helpful. And then on the, I guess, the discontinuation of IDgenetix, can you talk about how you will reinvest the spending associated with the personnel and the marketing for that product? And maybe like how much that business was burning? And if there's any like run rate savings net of severance that you can talk about?

知道了。這很有幫助。然後，我想，關於 IDgenetix 的停產，您能談談如何重新投資與該產品的人員和行銷相關的支出嗎？或許就像那家公司燒了多少錢？能談談扣除遣散費後的運轉率節省嗎？

Yes, not a lot of severance or changes. We were -- as we said, we had changed the marketing support for that test. We continue to believe it is a very good test. And of course, it's just, unfortunately, incredibly unmet medical need. But while payers in our business are rarely rational, they've been especially difficult in that one.

是的，遣散費或變動並不多。正如我們所說，我們已經改變了該測試的營銷支援。我們仍然相信這是一個非常好的測試。當然，不幸的是，這只是嚴重未被滿足的醫療需求。但是，雖然我們這個行業的付款人很少是理性的，但在這件事上他們尤其難纏。

And so, that led us to sort of the changes we made over the last several -- last couple of quarters. I think that we will see some modest impact to revenue, Kyle, but EBITDA will be benefited -- positively benefited from the change as well. So not big numbers there, but there will be some revenue -- some lower revenue, but at the end of the day, it will improve the EBITDA performance of the company.

因此，這導致我們在過去幾個季度中做出了一些改變。凱爾，我認為我們會看到收入受到一些適度的影響，但 EBITDA 也會受益——從這項變革中獲得積極的好處。因此，數字並不大，但會有一些收入——一些較低的收入，但最終，它將提高公司的 EBITDA 表現。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Hey guys, thanks for taking my question. So first one, Derek, I just wanted to understand, I think you gave a high single-digit volume growth for DecisionDx-Melanoma. I'm just trying to understand, where some of the offsets are and what TissueCypher growth ought to be in 2Q and for the full year? Just trying to reconcile the growth that -- implied growth for TissueCypher as a result of DecisionDx-Melanoma.

嘿夥計們，謝謝你們回答我的問題。首先，德里克，我只是想了解一下，我認為您給出了 DecisionDx-Melanoma 的高個位數銷售增長。我只是想了解，一些抵消因素在哪裡，以及 TissueCypher 在第二季和全年的成長應該是多少？只是試圖調和由於 DecisionDx-Melanoma 而導致的 TissueCypher 的增長。

So Frank, do you want to take that?

那麼弗蘭克，你想接受這個嗎？

Yes, sure. What we said, Puneet, is volume growth on melanoma of mid to high single digits for the year-over-year, '25 over '24. And we reiterated or we provided an apples-to-apples number. So the rest of the growth is TC. It's -- we also think we'll see some continued benefit or improvement in ASP on melanoma.

是的，當然。Puneet，我們所說的是，2025 年黑色素瘤的發生率與 2024 年相比將呈現中高個位數的同比增長。我們重申或提供了一個同類的數字。因此其餘的成長是 TC。我們也認為，我們將看到 ASP 對黑色素瘤的持續益處或改善。

The team has done great work there, and we continue to see very slow and very deliberate, but some continued progress on the ASP side there, which will benefit numbers as well. So good solid growth for TC, tough to keep it in the same kind of scale that we have, but good consistent linear growth from here through the year.

團隊在那裡做出了出色的工作，我們繼續看到 ASP 方面取得了非常緩慢、非常謹慎但持續的進展，這也將有利於數字。因此，TC 實現了良好而穩健的成長，雖然很難將其保持在現有的規模，但從現在到今年，它將保持良好的持續線性成長。

Got it. And on the TissueCypher, correct me if I'm wrong, but I think you're up to 65 sales reps. Can you remind us, what's the expectation for hiring for the rest of the year? And on the reimbursement side, can you just remind us where you stand with commercial reimbursement for -- and in terms of the priority for commercial reimbursement, where do you stand today for TissueCypher?

知道了。在 TissueCypher 上，如果我錯了請糾正我，但我認為你們有多達 65 名銷售代表。您能否提醒我們，今年剩餘時間的招募預期是什麼？在報銷方面，您能否提醒我們您對商業報銷的立場 - 就商業報銷的優先權而言，您目前對 TissueCypher 的立場是什麼？

So I think we discussed that we're around 65 sales territories with, I guess, year-end earnings, Puneet. So we are having training being completed, getting people's feet wet, we'll sort of take certainly a breath and make sure that we can understand if there are gaps in the marketplace right now and a need or a benefit to expand more in 2025 versus a little bit later.

所以我認為我們討論過我們大約有 65 個銷售區域，我想，年終收益，Puneet。因此，我們正在完成培訓，讓人們熟悉情況，我們肯定會喘口氣，確保我們能夠了解目前市場是否存在空白，以及在 2025 年而不是稍後進一步擴張的必要性或好處。

So I don't think we've discussed any public plans about near-term expansion. I think we need to kind of get through the second quarter here and see how the expanded efforts are educating the marketplace and producing results and then kind of go from there.

所以我認為我們還沒有討論過任何有關近期擴張的公開計劃。我認為我們需要度過第二季度，看看擴大的努力如何教育市場並產生結果，然後從那裡開始。

At the end of the day, if we are accurate in our assumption that we believe there's around 10,000 targetable clinicians or gastroenterologist and their associated support, then 65 still seems a little low, but we aren't quite sure, to be honest, if the larger group practice models that gastroenterologists practice in makes that number adequate or if it still needs to go up a couple of regions.

歸根結底，如果我們的假設準確，認為有大約 10,000 名目標臨床醫生或胃腸病學家及其相關支持，那麼 65 似乎仍然有點低，但老實說，我們不太確定胃腸病學家所從事的更大的團體實踐模式是否使這個數字足夠，或者是否仍然需要增加幾個地區。

Catherine Schulte, Baird.

凱瑟琳舒爾特，貝爾德。

This is Tom Peterson on for Catherine. Appreciate you guys for taking my question. Congrats on a solid quarter. First question, I kind of wanted to get the latest on sales and marketing efforts for DecisionDx-SCC and DecisionDx-Melanoma. You had talked about shifting the sales force incentives more towards melanoma once SEC coverage came out of the model.

我是湯姆·彼得森，取代凱瑟琳。感謝你們回答我的問題。恭喜本季業績穩健。第一個問題，我想了解 DecisionDx-SCC 和 DecisionDx-Melanoma 的最新銷售和行銷情況。您曾談到，一旦美國證券交易委員會 (SEC) 的報告脫離該模型，就將銷售團隊的誘因更多地轉向黑色素瘤。

So I guess, can you just confirm that, that is the strategy going forward and your thoughts on sort of the volume outlook for '25?

所以我想，您能否確認一下，這就是未來的策略，以及您對 25 年銷售前景的看法？

Yes, that is still the intention, Tom, is to have the field forces go from roughly kind of 50-50, I guess, I would call it, splitting time between melanoma and squamous cell carcinoma to being very heavily weighted going forward in the second half of the year to melanoma. We haven't had a single test focus in this marketplace, I think, probably since COVID, right, nothing, COVID.

是的，湯姆，我們的目的仍然是讓治療力量從大約 50-50（我想，我會這樣稱呼它）分配在黑色素瘤和鱗狀細胞癌上的時間，到下半年將重點放在黑色素瘤上。我認為，可能自從 COVID 以來，我們在這個市場上就沒有進行過任何測試，對吧，什麼都沒有，COVID。

So -- and we were much smaller there as a company. So it's hard to say what kind of, I guess, lift or acceleration one could see when we go back to a solely focused or predominantly solely focused field team in dermatology, but our expectations is that we should see some lift as appropriate.

所以——作為一家公司，我們的規模要小得多。因此，當我們回到專注於或主要專注於皮膚病學的現場團隊時，很難說會看到什麼樣的提升或加速，但我們的期望是，我們應該看到適當的提升。

That's really helpful. And then you mentioned the reconsideration requests for both MolDX and Novitas. I guess what's your latest thoughts on timing here? Should we expect an outcome here in 2025? And just your latest thoughts there?

這真的很有幫助。然後您提到了對 MolDX 和 Novitas 的重新考慮請求。我猜您對這裡的時間安排有什麼最新想法？我們是否應該期待 2025 年能得出結果？您最近有這樣的想法嗎？

Sure. So I think, first of all, our recommendation or guidance, I guess, in the last 1.5 years of having people remove squamous cell carcinoma from revenue models was obviously a good straight forward approach. And certainly, for the remainder of 2025, I would not have anybody reinsert SCC revenue assumptions.

當然。所以我認為，首先，我們在過去 1.5 年裡提出的建議或指導是讓人們將鱗狀細胞癌從收入模式中去除，這顯然是一種很好的直接方法。當然，對於 2025 年剩餘的時間，我不會讓任何人重新插入 SCC 收入假設。

I think on timing, it's difficult to project at this point in time. And I think as we see the year progress or the quarter progress or the quarters progress, we'll go and update the group as we have material knowledge. There is no real good benchmarking to kind of give you a evidence-based target there.

我認為，從時間上來說，目前還很難預測。我認為，當我們看到年度進展、季度進展或季度進展時，我們會根據所掌握的重要知識向小組更新。沒有真正好的基準來給你一個基於證據的目標。

Paul Knight, KeyBanc.

保羅奈特（Paul Knight），KeyBanc。

Thanks for taking my question. On the -- can you talk about the distribution of your sales force by test type, so we have an idea of where you're doing most adds this year?

感謝您回答我的問題。您能否談談您的銷售人員按測試類型的分佈情況，以便我們了解您今年在哪些方面做了最多的增加？

Yes, Paul. So as you said, the GI sales force is rough and top middle 60's and the derm sales force is high 60's, maybe around 70.

是的，保羅。所以正如你所說，GI 銷售人員的水平比較粗糙，在 60 多歲中上旬，而皮膚科銷售人員的水平在 60 多歲後期，大概在 70 多歲左右。

Could we expect that build and ramp to continue this year?

我們能否預期今年這種建設和擴張會持續下去？

The derm sales force, there may be some growth here and there as we see territories get full, get -- you see territories become kind of full of business, and we need more effort in the territory, may you take a territory and make it two or something like that. That will be more episodic, I think.

皮膚科銷售隊伍可能會有一些成長，因為我們看到各個地區都變得很滿，你會看到各個地區都充滿了業務，我們需要在各個地區做出更多的努力，你是否可以將一個地區變成兩個或類似的地區。我認為那將會更加具有情節性。

And as Derek said earlier, I think on the TC side, we want to settle into where we are and watch how the territories progress to see if we need to add another handful of reps there.

正如德里克之前所說，我認為在 TC 方面，我們希望安頓下來，觀察各地區的發展情況，看看是否需要在那裡增加一些代表。

Subbu Nambi, Guggenheim.

蘇布南比 (Subbu Nambi)，古根漢美術館。

Thank you for taking my question. Regarding the acquisition of Previse and your positioning of this as a complementary asset to TissueCypher, this conceptually makes sense. That said, it does seem, at least on the surface, similar to what you did with the MyPath acquisition a few years ago, which, as you know, came up light of targets. And I ask not to be heavy-handed, but I want to hear, what is different here and what lessons were learned that increase the probability of success? Because on paper, this definitely looks interesting.

感謝您回答我的問題。關於收購 Previse 以及將其定位為 TissueCypher 的補充資產，這在概念上是有道理的。話雖如此，至少從表面上看，這似乎與幾年前收購 MyPath 的做法類似，正如你所知，那次收購沒有找到目標。我要求不要採取嚴厲措施，但我想聽聽，這裡有什麼不同，以及吸取了哪些教訓可以增加成功的可能性？因為從紙上看，這絕對看起來很有趣。

I missed the last part of, very last part of your question.

我錯過了你問題的最後一部分。

Yes. I think -- so we -- Subbu, we do quite like the MyPath acquisition. We were able to pull up reimbursement for the differential diagnostic test, which was very important. We were able to add another offering to derms and derm path, which increased our value to them. We don't expect MyPath to get to the scale of CM or SCC given the nature of that market.

是的。我認為——所以我們——Subbu，我們確實很喜歡 MyPath 收購。我們能夠獲得鑑別診斷測試的報銷，這非常重要。我們能夠為皮膚科和皮膚科路徑提供另一種服務，這增加了我們對他們的價值。考慮到該市場的性質，我們並不認為 MyPath 能夠達到 CM 或 SCC 的規模。

But we also like having an ability to point to prognostic test in melanoma when MyPath results in a positive diagnosis from a previously indeterminate lesion. Previse is a bit different, however, and we are excited about the technology that comes along with it.

但是，當 MyPath 對先前不確定的病灶做出陽性診斷時，我們也希望能夠指出黑色素瘤的預後測試。然而，Previse 有點不同，我們對隨之而來的技術感到興奮。

As Derek said, there's going to be some work done and some interesting efforts to see if we can improve the prognostic offering, potentially with the multiomics approach at some point. But also Previse has a very interesting pipeline in GI. And as we've said before, it's our intent and goal to have multiple offerings to the GI community, particularly around the kind of the upper GI esophageal area.

正如德里克所說，我們將會進行一些工作並做出一些有趣的努力，看看我們是否可以改善預後服務，可能在某些時候採用多組學方法。但 Previse 在 GI 方面也有一個非常有趣的管道。正如我們之前所說，我們的意圖和目標是為胃腸道社區提供多種服務，特別是圍繞上消化道食道區域的服務。

And this brings us several candidates there. So different motivations for the two, but a nice expansion of our pipeline as well.

這給我們帶來了幾位候選人。因此兩者的動機不同，但對我們的管道來說也是一個很好的擴展。

And maybe I missed this, but how much is it getting reimbursed as in how does it compare to TissueCypher in terms of rate, Medicare rate? And will that play a role in decision-making for doctors?

也許我錯過了這一點，但它的報銷金額是多少？就費率、醫療保險費率而言，它與 TissueCypher 相比如何？這會對醫師的決策產生影響嗎？

Not -- I don't think it plays a role in decision-making. Their Medicare rate is lower than ours because ours is the ADLT. So that's a differential there. But not -- I don't think clinicians are making decisions that way. I think TC, we've been able to grow so quickly because of the robust body of evidence supporting the clinical utility and the high actionability of the test.

不——我不認為它在決策過程中發揮了作用。他們的醫療保險費率低於我們的，因為我們的是 ADLT。這就是差異所在。但不是——我不認為臨床醫生會那樣做決定。我認為 TC 之所以能夠如此快速地發展，是因為有大量證據支持該測試的臨床實用性和高度可操作性。

Mason Carrico, Stephens Inc.

梅森·卡里科（Mason Carrico），史蒂芬斯公司

Hey guys. Thanks for taking my question. Frank, on the margin guide, could you give us a bit more color on that assumption? Specifically, what are your expectations for SCC volumes in the back half of this year? Are you expecting them to trend higher, flatten out, go down?

嘿，大家好。感謝您回答我的問題。弗蘭克，關於邊距指南，您能否為我們提供更多關於該假設的說明？具體來說，您對今年下半年的 SCC 銷售有何預期？您預期它們會呈現上升趨勢、趨於平穩還是下降？

So the -- we would expect that as we shift promotion more fully to melanoma that we would see some some certainly slowing of growth. At some point, I think that plateaus and we begin to see the demand ebb a bit. But on the other hand, Mason, it's a test that physicians are -- as you can see from volumes, physicians have really embraced it. It helps their practice. It helps their patients.

因此，我們預計，隨著我們將推廣重點轉向黑色素瘤，我們將看到其成長速度有所放緩。我認為，到了某個時候，需求就會趨於平穩，我們會開始看到需求下降。但另一方面，梅森，這是對醫生的一項測試——正如你從數量上看到的那樣，醫生確實接受了它。這有助於他們的練習。它可以幫助他們的病人。

It helps their patient management. And it saves Medicare almost $1 billion a year by appropriately directing patients to adju radiation therapy who will benefit from it and directing patients who won't benefit away. So we -- one way of saying that without promotion, most high-value diagnostic tests do not grow. But this is also a test that has great value to the users and to the health care system.

它有助於他們的病人管理。透過適當指導受益的患者接受放射治療，並讓不會受益的患者離開，該療法每年可為醫療保險節省近 10 億美元。因此，我們可以這麼說：如果沒有推廣，大多數高價值診斷測試就不會成長。但這也是一項對用戶和醫療保健系統具有重大價值的測試。

No, that makes sense. And then as a follow-up, how are you thinking about the growth algorithm of DecisionDx-Melanoma going forward? And I guess, in terms of same-store sales versus increasing the number of ordering clinicians, I mean, obviously, you probably benefit from both, both are important. But how do you have the reps, I guess, splitting their time between driving utilization or out hunting for new clinicians?

不，這很有道理。然後作為後續問題，您如何看待 DecisionDx-Melanoma 未來的成長演算法？我想，就同店銷售額與增加訂購臨床醫生的數量而言，顯然，您可能會從兩者中受益，兩者都很重要。但我想，你該如何讓銷售代表分配他們的時間，在推動利用率和尋找新的臨床醫生之間做出選擇呢？

So historically, I guess, I would say that we looked at a combination of forward-looking revenue per territory, as well as number of actively ordering customers, I guess, you would say. And what we had found, which I think is -- I don't know if there's a real industry standard here, Mason or not, but when we have a territory get up around, what, Frank, $2 million, $2.5 million, $3 million forward-looking revenue, then that becomes a territory that usually, if you go back and look at sort of where the representatives are spending time, it's more on maintaining existing customers and less on hunting for new clinicians, and that's kind of about the time we choose to go ahead and divide.

所以從歷史上看，我想，我們會綜合考慮每個地區的前瞻性收入，以及積極訂購的客戶數量，我想，你會這麼說。而我們發現，我認為是——我不知道這裡是否有一個真正的行業標準，不管是不是梅森，但是當我們圍繞一個領域展開時，弗蘭克，200 萬美元、250 萬美元、300 萬美元的前瞻性收入，那麼這個領域通常就變成了這樣，如果你回過頭來看看代表們把時間花在哪裡，你會發現他們更多的是現有的客戶劃分

And usually, success to get success, you probably have two successful territories adjacent to each other. So you might take two and make them into three, for example. I think that rule of thumb still holds pretty well.

通常，為了獲得成功，你可能會擁有兩個相鄰的成功領域。例如，您可以將兩個變成三個。我認為這個經驗法則仍然適用。

So what that ends up doing is letting us spend hopefully roughly half our time nurturing and educating current clinicians about where they could appropriately expand the use of our test in our patient population and then roughly half their time moving people from an awareness or no awareness to awareness and hopefully usage and adoption.

因此，最終我們可以花費大約一半的時間來培養和教育當前的臨床醫生，讓他們了解如何在患者群體中適當擴大我們測試的使用範圍，然後花費大約一半的時間來讓人們從意識到或沒有意識到，並希望能夠使用和採用。

Thomas Flaten, Lake Street.

托馬斯·弗拉頓，湖街。

Thank you for taking my question. Derek, probably a difficult question to answer, but you said in your prepared remarks that you would continue offering SCC for now. Do you have a sense of how for now -- how long for now will last given that there's a bit of a black box around the reconsideration requests and the time line there?

感謝您回答我的問題。德里克，這可能是一個很難回答的問題，但你在準備好的演講中說過，你現在將繼續提供 SCC。考慮到重新審議請求和時間線方面存在一些未知數，您是否知道現在的情況—現在的情況會持續多久？

No, I don't want to have more information or insight to go ahead and guide, unfortunately. I think for now is that, we need to understand how our interactions play out with Medicare, and that will help make a determining factor of how we want to approach that. I think from a purely ethical perspective today,

不，不幸的是，我不想獲得更多資訊或見解來繼續指導。我認為現在的情況是，我們需要了解我們與醫療保險的互動情況，這將有助於決定我們如何處理這個問題。我認為從今天純粹的道德角度來看，

I guess you would say we have a test here, which when used properly, can help a patient and their clinician care team from their dermatological or surgeon to their radiation oncologists identify people who may be considering adjuvant radiation therapy and probably take about 60% plus of them out of that therapy course because they will receive based upon our data, no clinical benefit, but substantial side effects and at a great cost to Medicare.

我想你會說我們這裡有一個測試，如果使用得當，可以幫助患者及其臨床護理團隊（從皮膚科醫生或外科醫生到放射腫瘤學家）識別可能正在考慮輔助放射治療的人，並可能使其中約 60％ 以上的人退出治療過程，因為根據我們的數據，他們不會獲得臨床益處，但會產生很大的副作用，而且會給醫療保險帶來巨大的成本。

So for the time being, we feel obligated to make sure that those patients are benefiting. Now Medicare benefits to the tune of around $2.4 million per day and avoiding unnecessary radiation therapies, and that's net of the cost of our test. So we're going to have to kind of wait and see how we work through the reconsideration process and make a call as those -- as that becomes clear.

因此，就目前而言，我們感到有義務確保這些患者能夠受益。現在，醫療保險福利每天高達約 240 萬美元，並可避免不必要的放射治療，這也扣除了我們的測試費用。因此，我們將不得不等待，看看我們如何完成重新考慮的過程，並在情況明朗時做出決定。

And then any update on atopic dermatitis?

那麼關於異位性皮膚炎還有什麼最新消息嗎？

Not since the end of the year-end earnings. We are still moving through market research to appreciate both the interest in our clinicians regarding the product profile, as well as the reimbursement strategy, and we believe we are still on track to achieving our milestone we set a couple of years ago, which was commercial availability by year-end.

自年底獲利以來就沒有了。我們仍在進行市場調查，以了解我們的臨床醫生對產品概況以及報銷策略的興趣，並且我們相信我們仍有望實現幾年前設定的里程碑，即在年底前實現商業化。

Mark Massaro, BTIG.

BTIG 的馬克馬薩羅。

Hey guys. Thank you for taking my question. On the acquisition that you just announced, was there any stock included in the deal? Or was it cash? And if you're not willing to share the terms of the deal, is it safe to say that the -- any level of cash would be immaterial to your cash balance?

嘿，大家好。感謝您回答我的問題。關於您剛剛宣布的收購，交易中是否包含股票？還是現金？如果您不願意分享交易條款，那麼是否可以肯定地說—任何現金水準對您的現金餘額都無關緊要？

There was no stock, Mark, and we've not disclosed the value of the transaction.

馬克，沒有股票，我們也沒有透露交易價值。

Okay. For investors on the line that might be thinking this question, the timing of the acquisition sort of coincides with your decision to shutdown the IDgenetix business, which you admittedly did telegraph or I believe you did. And then it also coincides with the lapping of the SCC payments from your Medicare contractor for the time being.

好的。對於可能正在思考這個問題的投資者來說，此次收購的時間與您關閉 IDgenetix 業務的決定有點相吻合，您承認您確實發出了這一信號，或者我相信您確實發出了這一信號。然後，它也與您的醫療保險承包商暫時重疊支付 SCC 費用的時間相吻合。

To what extent does the timing of this deal influence your probability of winning sort of SEC reimbursement back? Because optically, this almost could look like your ability to win in a Medicare reconsideration request might be smaller than it might have been a quarter ago? Or could you just speak to that? Because obviously, you announced a new deal, the timing of these other two going away.

這筆交易的時機在多大程度上影響了您贏得美國證券交易委員會 (SEC) 補償的可能性？因為從表面上看，這幾乎看起來就像您在醫療保險重新考慮請求中獲勝的能力可能比季度前更小？或者可以直接談一下這個嗎？因為很明顯，你宣布了一項新協議，而另外兩項協議的取消時間也隨之而來。

Completely underwrite it.

完全承保。

Okay. And then last quick question. I know you were asked about what you acquired. What I don't understand is, how much revenue this asset was producing in 2024. And then for the Sponge technology, this does look similar to another test on the market called EsoGuard.

好的。最後一個快速問題。我知道有人問你獲得了什麼。我不明白的是，這項資產在 2024 年能產生多少收入。然後對於海綿技術，這看起來確實與市場上另一種名為 EsoGuard 的測試類似。

Is it safe to say that the Sponge technology or the non-endoscopic technology and the EsoGuard test have some similarities in the marketplace? And then if you could, where does that stand in terms of data and Medicare coverage?

是否可以肯定地說，Sponge 技術或非內視鏡技術與 EsoGuard 測試在市場上有一些相似之處？那麼，如果可以的話，從數據和醫療保險覆蓋角度來看，情況如何？

So revenue is not material to Castle for the year. This is a technology opportunity for us and a pipeline opportunity, first and foremost, as well as a nice way to potentially improve our prognostic offering for Barrett's. And the Medicare process for non-endoscopic diagnosis, there is -- there are policies, draft policies out there, I believe.

因此，今年的收入對 Castle 來說並不重要。對我們來說，這首先是一個技術機會，也是一個管道機會，同時也是一個潛在地改善我們對巴雷特的預測的好方法。我相信，對於非內視鏡診斷的醫療保險流程，已經存在政策和政策草案。

But this technology is not at the point of seeking Medicare coverage yet. Although -- and just to note, Mark, there are, of course, more than just one other. There are a couple of non-endoscopic methods for diagnosis, not only for Barrett's, other conditions as well. So in that respect, there's some similarity to those other technologies.

但這項技術尚未達到尋求醫療保險覆蓋的程度。不過——馬克，要注意的是，當然不只一個。有幾種非內視鏡診斷方法，不僅適用於巴雷特食道癌，也適用於其他疾病。因此從這個方面來看，它與其他技術有一些相似之處。

Kyle Mikson, Canaccord Genuity.

凱爾米克森（Kyle Mikson），Canaccord Genuity。

Thanks, just want to ask about the acquisition and the pipeline and keep talking about it. Derek, can you talk about the timing of the pipeline launches and how large those opportunities are? And then just secondly, since you're getting access to the Johns Hopkins PCR-based methylation technology, have you ruled out using that tech to develop like an early detection or screening test for GI cancers?

謝謝，我只是想問一下有關收購和渠道的問題，並繼續談論它。德里克，您能談談管道投產的時間以及這些機會有多大嗎？其次，既然您獲得了基於約翰霍普金斯 PCR 的甲基化技術，您是否排除了使用該技術來開發胃腸道癌症的早期檢測或篩檢測試？

Haven't ruled it out, Kyle, haven't ruled it in, to be clear, but not -- certainly wouldn't have stopped any opportunities there. I think that the opportunity we have is to accelerate the development of the pipeline that the company had with additional resources, but also our broader expertise in GI and our somewhat deeper history of R&D.

凱爾，我沒有排除這種可能性，沒有排除這種可能性，但要清楚，當然不會阻止任何機會。我認為我們的機會是利用額外的資源來加速公司現有產品線的開發，同時也利用我們在 GI 方面的更廣泛的專業知識和更深厚的研發歷史。

So we're ways out on the pipeline technologies. I don't know that we're ready to put a pin in the ground on where -- what the time lines would be, but we certainly think we can accelerate them from what they might otherwise have been.

所以我們在管道技術方面還有很長的路要走。我不知道我們是否準備好明確時間表，但我們確信我們可以加快進程。

Okay, thanks for that.

好的，謝謝。

There are no additional questions waiting at this time. So I would like to pass the call back over to Derek for any closing remarks.

目前沒有其他問題。因此，我想將電話轉回給 Derek，讓他做最後的總結發言。

Thank you, operator. This concludes our first quarter 2025 earnings call. We thank you again for joining us today and for your continued interest in Castle Biosciences.

謝謝您，接線生。我們的 2025 年第一季財報電話會議到此結束。我們再次感謝您今天的加入我們以及您對 Castle Biosciences 的持續關注。

That concludes today's call. Thank you for your participation, and enjoy the rest of your day.

今天的電話會議到此結束。感謝您的參與，祝您今天過得愉快。