Fulgent Genetics Inc (FLGT) 2025 Q2 法說會逐字稿

Greetings, and welcome to the Fulgent Genetics Q2 2025 conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Fulgent Genetics 2025 年第二季電話會議和網路廣播。（操作員指示）提醒一下，本次會議正在錄音。

It's now my pleasure to introduce your host, Lauren Sloane, Investor Relations. Please go ahead.

現在我很高興介紹主持人、投資者關係部勞倫‧斯隆 (Lauren Sloane)。請繼續。

Thank you, and good morning, and welcome to the Fulgent second-quarter 2025 financial results conference call. On the call today are Ming Hsieh, Chief Executive Officer; Paul Kim, Chief Financial Officer; and Brandon Perthuis, Chief Commercial Officer.

謝謝，早安，歡迎參加 Fulgent 2025 年第二季財務業績電話會議。參加今天電話會議的有執行長 Ming Hsieh、財務長 Paul Kim 和首席商務官 Brandon Perthuis。

The company's press release discussing the financial results is available on the Investor Relations section of the company's website, ir.fulgentgenetics.com. A replay of this call will be available shortly after the call concludes on the Investor Relations section of the company's website. Management's prepared remarks and answers to your questions on today's call will contain forward-looking statements.

本公司有關財務表現的新聞稿可在本公司網站ir.fulgentgenetics.com的投資人關係版面查看。本次電話會議的重播將在電話會議結束後不久在公司網站的投資者關係版塊提供。管理層在今天的電話會議上準備的評論和對您問題的回答將包含前瞻性陳述。

These forward-looking statements represent management's estimates based on current views, expectations, and assumptions, which may prove to be incorrect. As a result, matters discussed in any forward-looking statements are subject to risks, uncertainties, and changes in circumstances that may cause actual results to differ from those described in the forward-looking statements.

這些前瞻性陳述代表管理階層基於當前觀點、預期和假設的估計，但可能被證明是不正確的。因此，任何前瞻性陳述中討論的事項都可能受到風險、不確定性和情況變化的影響，這些因素可能導致實際結果與前瞻性陳述中描述的結果不同。

The company assumes no obligation to update any of the forward-looking statements it may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions or future events and should listen to management's remarks today with the understanding that actual events, including the company's actual future results, may be materially different than what is described in or implied by these forward-looking statements.

本公司不承擔更新今天所做的任何前瞻性陳述以反映實際結果或預期變化的義務。聽眾不應依賴任何前瞻性陳述作為預測或未來事件，而應在聽取管理層今天的言論的同時，理解實際事件（包括公司的實際未來結果）可能與這些前瞻性陳述中描述或暗示的內容存在重大差異。

Please review the more detailed discussion related to these forward-looking statements, including the discussion of some of the risk factors that may cause results to differ from those described in the forward-looking statements contained in the company's filings with the Securities and Exchange Commission, including the previously filed 10-K for the year ended December 31, 2024, and subsequently filed reports, which are available on the company's Investor Relations website.

請查看與這些前瞻性陳述相關的更詳細討論，包括對可能導致結果與公司向美國證券交易委員會提交的文件中前瞻性陳述所述結果不同的某些風險因素的討論，包括對可能導致結果與公司的投資者關係網站上查閱。

Management's prepared remarks, including discussions of profit, loss, margin, earnings, and earnings per share contain financial measures not prepared in accordance with accounting principles generally accepted in the United States or GAAP. Management has presented these non-GAAP financial measures because it believes they may be useful to investors for various reasons, but these measures should not be viewed as a substitute for, or superior to, the company's financial results prepared in accordance with GAAP.

管理階層的準備意見，包括對利潤、損失、利潤率、收益和每股收益的討論，包含未按照美國公認會計原則或 GAAP 編制的財務指標。管理階層之所以提出這些非 GAAP 財務指標，是因為他們認為這些指標可能因各種原因對投資者有用，但這些指標不應被視為替代或優於公司根據 GAAP 編制的財務結果。

Please see the company's press release discussing the financial results for second-quarter 2025 for more information, including the description of how the company calculates non-GAAP income, loss, non-GAAP earnings, loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit and loss and margin, and adjusted EBITDA and a reconciliation of these financial measures to income or loss, earnings and loss per share and operating margin, the most directly comparable GAAP financial measures.

請參閱公司關於 2025 年第二季度財務業績的新聞稿，了解更多信息，包括公司如何計算非 GAAP 收入、虧損、非 GAAP 收益、每股虧損、非 GAAP 毛利、非 GAAP 毛利率、非 GAAP 營業利潤和虧損及利潤率以及調整後的 EBITDA，以及這些財務可與財務收益、每股收益和虧損）

With that, I now turn the call over to Ming. Please go ahead.

說完這些，我現在把電話轉給 Ming。請繼續。

Thank you, Lauren. Good morning, and thank you for joining our call today. I will start with some comments on the second quarter of 2025 and our two business lines. Then Brandon will review our product and go-to-market updates for our Laboratory Services business and Paul will conclude with the financials and outlook before we take your questions.

謝謝你，勞倫。早安，感謝您今天參加我們的電話會議。我將首先對 2025 年第二季和我們的兩條業務線發表一些評論。然後，布蘭登將回顧我們的實驗室服務業務的產品和上市更新，保羅將在我們回答您的問題之前總結財務和前景。

We are pleased with our second-quarter results. We have shown both sequential and year-over-year growth in Laboratory Services. We are pleased with the momentum we are seeing as we move through 2025. Our therapeutic development pipeline is on track.

我們對第二季的業績感到滿意。我們的實驗室服務實現了連續和同比增長。我們對 2025 年所看到的勢頭感到高興。我們的治療開發流程正在順利進行中。

Our first clinical candidate, FID-007, is progressing through a Phase II clinical trial in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma with 32 patients enrolled and dosed. We expect to complete patient enrollment by the end of this year with the data readout in 2026. We project the clinical trial of Phase II to be approximately $30 million over a multiyear period.

我們的首個臨床候選藥物 FID-007 正在進行 II 期臨床試驗，該試驗與西妥昔單抗聯合用於治療復發性或轉移性頭頸部鱗狀細胞癌患者，共有 32 名患者入組並接受治療。我們預計在今年底完成患者招募，並於 2026 年讀取數據。我們預計第二階段臨床試驗將在多年內耗資約 3,000 萬美元。

Our second clinical candidate, FID-022, beginning of Phase I trial and the first book of patients has been enrolled. FID-022 is a nanoencapsulation agent for treatment of solid tumors including potentially colon, pancreatic, ovarian, and bile duct cancers. We continue to expect clinical trial cost of Phase I trial of FID-022 to be approximately $8 million.

我們的第二個臨床候選藥物 FID-022 已開始 I 期試驗並已招募第一批患者。FID-022 是一種用於治療實體腫瘤（包括結腸癌、胰腺癌、卵巢癌和膽管癌）的奈米膠囊劑。我們繼續預期 FID-022 第一階段試驗的臨床試驗成本約為 800 萬美元。

I am encouraged by the continued progress with our clinical pipeline and the potential for both FID-007 and FID-022. These drug candidates address heavily pretreated patients with very few options left. I hope we'll be able to provide alternatives to further their lives. Our anticipated cost for these programs is very reasonable and we believe our investment will be rewarded.

我對我們的臨床管線的持續進展以及 FID-007 和 FID-022 的潛力感到鼓舞。這些候選藥物針對的是那些已經接受過大量治療、且治療選擇已經所剩無幾的患者。我希望我們能夠提供替代方案來改善他們的生活。我們對這些項目的預期成本非常合理，我們相信我們的投資將會獲得回報。

Overall, I'm pleased with our progress in the first half of the year in both our business areas. We'll continue to be in a strong financial position to execute our strategy. I'd like to thank our employees, partners, and stakeholders, for your hard work and loyalty in a great quarter for our business. We look forward to further progress in the second half of 2025.

整體而言，我對我們兩個業務領域上半年的進展感到滿意。我們將繼續保持強勁的財務狀況來執行我們的策略。我要感謝我們的員工、合作夥伴和利益相關者，感謝你們在我們業務取得巨大成功的一個季度中付出的辛勤工作和忠誠。我們期待2025年下半年取得進一步進展。

I'll now turn the call over to Brandon Perthuis, our Chief Commercial Officer, to talk more about the Laboratory Services business. Brandon?

現在我將把電話轉給我們的首席商務官 Brandon Perthuis，進一步討論實驗室服務業務。布蘭登？

Thanks, Ming. We had a very successful quarter with all areas of our business performing well and delivering nearly $81.7 million in core revenue which is up 16% year over year and 11% sequentially. On a sequential basis, Precision Diagnostics was up 7%, Biopharma Services was up 54%, and Anatomic Pathology was up 11%.

謝謝，明。我們度過了一個非常成功的季度，所有業務領域都表現良好，核心收入接近 8,170 萬美元，年增 16%，環比成長 11%。以環比計算，Precision Diagnostics 上漲 7%，Biopharma Services 上漲 54%，Anatomic Pathology 上漲 11%。

During the second quarter, we launched a new whole genome sequencing service. While we have offered whole genome sequencing for some time, our latest version includes several new features that clinicians find important. For example, we have moved to a PCR-free NGS test, which provides more uniform coverage and reduces amplification bias from traditional PCR-based library preparation leading to higher accuracy in variant calling. Our new whole genome includes exceptional resolution detecting CNVs with greater than two exome resolution and genome-wide del/dup surpassing traditional exome sequencing.

第二季度，我們推出了新的全基因組定序服務。雖然我們提供全基因組定序已有一段時間了，但我們的最新版本包含了臨床醫生認為重要的幾個新功能。例如，我們已經轉向無 PCR 的 NGS 測試，它提供了更均勻的覆蓋範圍並減少了傳統基於 PCR 的文庫製備的擴增偏差，從而提高了變異調用的準確性。我們的新全基因組包括卓越的分辨率，可檢測出具有大於兩個外顯子組分辨率的 CNV，並且全基因組的 del/dup 超越了傳統的外顯子組測序。

In addition, we are one of the only laboratories who integrate RNA sequencing into the interpretation. Integrated RNA analysis provides functional insights into genetic variants, enabling deeper characterization of pathogenicity. RNA is able to detect aberrant gene expression, monoallelic gene expression, and aberrant splicing of express target genes.

此外，我們是唯一將 RNA 定序整合到解釋中的實驗室之一。整合 RNA 分析提供了對基因變異的功能洞察，從而能夠更深入地表徵致病性。RNA 能夠檢測異常基因表現、單一等位基因表現和表現目標基因的異常剪接。

Further building momentum for genomic sequencing, the American Academy of Pediatrics recently recommended exome and genome sequencing as a first-tier test for children with global developmental delay or intellectual disability. This is a significant milestone for genomic sequencing and for those patients and families who can benefit from it. This new practice guideline puts a powerful diagnostic tool in the hands of more than 60,000 pediatricians across the country.

為了進一步推動基因組定序的發展，美國兒科學會最近推薦外顯子組和基因組定序作為全面發育遲緩或智力障礙兒童的一級測試。對於基因組定序以及從中受益的患者和家庭來說，這是一個重要的里程碑。這項新的實踐指南為全國 60,000 多名兒科醫生提供了強大的診斷工具。

Another key development in our genomic testing was that we received the certified CE Mark for FulgentExome and Fulgent Pipeline Manager. To our knowledge, we may be the first laboratory to receive CE Mark for such a comprehensive end-to-end germline testing service.

我們基因組測試的另一個關鍵進展是我們獲得了 FulgentExome 和 Fulgent Pipeline Manager 的 CE 標誌認證。據我們所知，我們可能是第一個獲得如此全面的端到端種系檢測服務 CE 標誌的實驗室。

FulgentExome is a patient-centric phenotype-driven analysis designed to examine coding regions and splice junctions from more than 4,600 genes and to report only the variants which are of plausible clinical relevance. It is a next-generation sequencing-based system designed for clinical exome analysis to identify germline variants to aid the clinical diagnosis of suspected genetic conditions relevant to the patient's clinical and family history.

FulgentExome 是一種以患者為中心的表型驅動分析，旨在檢查 4,600 多個基因的編碼區域和剪接點，並僅報告具有合理臨床相關性的變異。它是基於次世代定序的系統，專為臨床外顯子組分析而設計，用於識別種系變異，以幫助臨床診斷與患者臨床和家族史相關的疑似遺傳疾病。

Fulgent PLM is an in vitro diagnostic software used with FulgentExome to analyze genetic information derived from sequencing data. FulgentExome is ideal for patients who have a complex or very rare combination of phenotypes that are not suggestive of any recognizable syndrome or for whom previous focused testing has been negative.

Fulgent PLM 是一款體外診斷軟體，與 FulgentExome 一起使用，用於分析來自定序資料的遺傳資訊。FulgentExome 非常適合那些具有複雜或非常罕見的表型組合且不提示任何可識別的綜合徵或先前的重點檢測結果為陰性的患者。

The American College of Medical Genetics and Genomics recommends exome or genome as a first-line test for development of delay, intellectual disability, and congenital anomalies. The National Society of Genetic Counselors recommends exome or genome as first-line test for all individuals with unexplained epilepsy and this guideline is endorsed by the American Epilepsy Society. With the CE Mark, we can now make FulgentExome available to clinics and hospital systems throughout Europe, helping families get answers to complex clinical phenotypes. We believe the CE Mark is an important step to growing our global business.

美國醫學遺傳學和基因組學學院建議將外顯子組或基因組作為發育遲緩、智力障礙和先天性異常的第一線檢測。美國國家遺傳諮詢師協會建議對所有不明原因癲癇患者進行外顯子組或基因組檢測作為一線檢測，該指南得到了美國癲癇協會的認可。憑藉 CE 標誌，我們現在可以讓 FulgentExome 提供給整個歐洲的診所和醫院系統，幫助家庭獲得複雜臨床表型的答案。我們相信 CE 標誌是我們發展全球業務的重要一步。

An area we continue to make progress in is managed care. Since January, we have executed over 20 new agreements, adding over 35 million new covered lives to our in-network contracts. We believe with our extensive product portfolio, excellent turnaround time, and other features around bioinformatics and AI, we present as a valuable partner to payers. The focus for the managed care team going forward is to continue maintaining excellent relationships with our key payer partners and continue to expand our in-network coverage across the country.

我們不斷取得進展的一個領域是管理式醫療。自一月份以來，我們已經簽署了 20 多項新協議，為我們的網路內合約增加了 3500 多萬新的受保人次。我們相信，憑藉我們廣泛的產品組合、出色的周轉時間以及圍繞生物資訊學和人工智慧的其他功能，我們可以成為付款人的寶貴合作夥伴。管理式醫療團隊未來的重點是繼續與我們的主要付款人合作夥伴保持良好的關係，並繼續擴大我們在全國範圍內的網路覆蓋範圍。

We believe we are firing on all cylinders and investing in the right areas to continue to expand our capabilities and commercial reach. We were excited to deliver a successful second quarter as well as increase our annual revenue guidance for 2025. For the second half of the year, the focus will be on gaining additional market share in the three areas of our business as well as continuing to expand the sales organization.

我們相信，我們正在全力以赴並在正確的領域進行投資，以繼續擴大我們的能力和商業影響力。我們很高興看到第二季取得成功，並提高了 2025 年的年度營收預期。下半年，我們的重點將放在擴大三個業務領域的市場份額以及繼續擴大銷售組織。

I'd like to thank the Fulgent team for all of their hard work and dedication, and I'll now turn the call over to Paul Kim, our Chief Financial Officer. Paul?

我要感謝 Fulgent 團隊的所有辛勤工作和奉獻精神，現在我將把電話轉給我們的財務長 Paul Kim。保羅？

Thank you, Brandon. Revenue in the second quarter of 2025 totaled $81.8 million compared to $73.5 million in the first quarter of 2025. The revenue from COVID-19 testing is negligible. Revenue from our core business totaled $81.7 million. Gross margin on a non-GAAP basis was 44.2% and a GAAP basis was 42.1%. Gross margins improved year over year and sequentially due to streamlined operations, enhanced efficiency and the impact of certain onetime adjustments.

謝謝你，布蘭登。2025 年第二季的營收總計 8,180 萬美元，而 2025 年第一季的營收總計 7,350 萬美元。COVID-19 檢測的收入微不足道。我們核心業務的收入總計 8,170 萬美元。非 GAAP 毛利率為 44.2%，GAAP 毛利率為 42.1%。由於精簡營運、提高效率以及某些一次性調整的影響，毛利率年比和季比均有所提高。

Turning to the operating expenses, non-GAAP operating expenses totaled $43.9 million compared to $37.4 million in the first quarter of 2025. Total GAAP operating expense was $54.1 million in the second quarter compared to $48.1 million in the first quarter of 2025. The rise in operating expenses reflected two key investments, the expected increase in R&D spending to support our clinical studies and higher sales and marketing costs driven by the expansion of our sales team and ramped up marketing initiatives.

談到營運費用，非 GAAP 營運費用總計 4,390 萬美元，而 2025 年第一季為 3,740 萬美元。第二季 GAAP 總營運費用為 5,410 萬美元，而 2025 年第一季為 4,810 萬美元。營業費用的增加反映了兩項關鍵投資：為支持我們的臨床研究而預期增加的研發支出，以及由於我們的銷售團隊擴張和行銷舉措加強而導致的銷售和行銷成本增加。

Non-GAAP operating margin increased slightly sequentially to a minus 9.4%. Our GAAP loss was $19 million for the quarter, included a onetime noncash charge related to a $9.9 million impairment of a prior investment. Adjusted EBITDA loss for the second quarter was approximately $3 million compared to a loss of $2.9 million in Q1 of 2025. On a non-GAAP basis and excluding equity-based compensation expense, intangible asset amortization and impairment loss income for the quarter was approximately $2.1 million or a positive $0.07 per share on 30.7 million weighted average diluted shares outstanding.

非公認會計準則營業利益率較上月小幅上升至負 9.4%。本季我們的 GAAP 虧損為 1,900 萬美元，其中包括與 990 萬美元前期投資減損相關的一次性非現金費用。第二季調整後的 EBITDA 虧損約為 300 萬美元，而 2025 年第一季的虧損為 290 萬美元。以非公認會計準則計算，且不包括股權激勵費用，本季無形資產攤銷和減損損失收入約為 210 萬美元，或每股收益為正 0.07 美元，加權平均稀釋流通股數為 3,070 萬股。

In the second quarter, we repurchased approximately 130,000 shares at an aggregated cost of $2.2 million pursuant to our stock repurchase program. Since the inception of the stock repurchase program in March 2022, a total of approximately $110.4 million has been spent with approximately $139.6 million remaining available for future repurchases of our common stock.

第二季度，我們根據股票回購計畫回購了約 13 萬股，總成本為 220 萬美元。自 2022 年 3 月啟動股票回購計畫以來，已累計花費約 1.104 億美元，剩餘約 1.396 億美元可用於未來回購普通股。

Turning to the balance sheet, we ended the second quarter with approximately $777.5 million in cash, cash equivalents, restricted cash and marketable securities. Cash used in the period included $31.7 million for income tax credits purchased as mentioned earlier, $2.2 million of the stock repurchase. We guide to core revenue, which is Laboratory Services revenue for the company without COVID-19 testing revenue.

談到資產負債表，我們在第二季結束時擁有約 7.775 億美元的現金、現金等價物、受限現金和有價證券。本期間使用的現金包括前面提到的購買所得稅抵免 3,170 萬美元，以及股票回購 220 萬美元。我們以核心收入為指導，即公司的實驗室服務收入（不包括 COVID-19 檢測收入）。

To reflect current business performance, we're adjusting our revenue outlook for the remainder of the year increasing revenue guidance from $310 million to $320 million for 2025, representing a growth of 14% year over year. We continue to expect non-GAAP gross margins for the full year to slightly exceed 40%, continuing the strong momentum we experienced in recent quarters. We expect non-GAAP operating margins to improve from minus 15% to minus 13% for the year, driven largely by increased revenue.

為了反映當前的業務表現，我們調整了今年剩餘時間的營收預期，將 2025 年的營收預期從 3.1 億美元提高到 3.2 億美元，年增 14%。我們繼續預計全年非公認會計準則毛利率將略高於 40%，延續最近幾季的強勁勢頭。我們預計，今年非公認會計準則營業利潤率將從-15%提高至-13%，這主要得益於收入的成長。

We continue to invest in business growth, further develop laboratory operations, and enhance our existing laboratory facilities. We remain focused on managing our spending and continue to believe that our foundational technology platform supports a strong margin profile in the longer term.

我們繼續投資於業務成長，進一步發展實驗室運營，並增強我們現有的實驗室設施。我們仍然專注於管理我們的支出，並繼續相信我們的基礎技術平台能夠在長期內支持強勁的利潤率。

In July, we closed the acquisition of ANP Technologies for an enterprise value of approximately $4 million. ANP has already played a pivotal role in Fulgent Pharma's R&D progress through a long-standing licensing agreement that granted access to proprietary nano drug delivery technology supporting our lead drug candidates, FID-007 and FID-022. With this acquisition, we now own the core intellectual property, enabling full control over the development, expansion, and future commercialization of these and related formulations, both in oncology and potentially beyond. However, even with this acquisition included, we continue to expect our associated cash burn for therapeutic development business to remain at approximately $25 million this year, which is contemplated in our EPS and cash guidance.

7 月，我們完成了對 ANP Technologies 的收購，企業價值約 400 萬美元。 ANP透過長期授權協議，Fulgent Pharma 已在研發過程中發揮了關鍵作用，該協議授予其使用支援我們的主要候選藥物 FID-007 和 FID-022 的專有奈米藥物輸送技術的權利。透過此次收購，我們現在擁有了核心智慧財產權，能夠完全控制這些製劑及相關製劑在腫瘤學及其他領域的開發、擴展和未來商業化。然而，即使包括此次收購，我們仍預計今年治療開發業務的相關現金消耗仍將保持在約 2500 萬美元，這已在我們的每股收益和現金指導中考慮到。

Using an average share count of 32 million, we now expect an improvement to our full-year 2025 non-GAAP EPS guidance from a loss of $0.65 per share to a loss of $0.35 per share, excluding stock-based compensation, impairment, and amortization of intangible assets as well as any onetime charges. Reflecting the improvement in our operations, which has offset the effect of our onetime noncash impairment adjustment, we're now revising our GAAP EPS guidance to a loss of $2.10 per share from $1.95 per share, excluding any future onetime charges using a 32 million average share count.

以平均 3,200 萬股計算，我們現在預計 2025 年全年非 GAAP 每股盈餘指引將從每股虧損 0.65 美元改善至每股虧損 0.35 美元，不包括股票薪酬、減損和無形資產攤銷以及任何一次性費用。鑑於我們營運的改善，抵消了一次性非現金減損調整的影響，我們現在將 GAAP EPS 預期從每股虧損 1.95 美元修訂為每股虧損 2.10 美元，不包括任何未來的一次性費用，採用 3,200 萬股平均股數。

Finally, our cash position remains strong. We're focused on efficient capital allocation that allows us to invest in future business, fund key initiatives, and to support future growth. Excluding any future stock repurchases or other expenditures outside of the ordinary course, which could include M&A, we anticipate ending 2025 with approximately $770 million of cash, cash equivalents, restricted cash, and investments in marketable securities. Overall, we see strength in our core business, which has grown organically, and we see good momentum for the balance of 2025.

最後，我們的現金狀況依然強勁。我們專注於高效的資本配置，以便我們投資未來業務、資助關鍵計劃並支持未來成長。不包括任何未來股票回購或正常業務以外的其他支出（可能包括併購），我們預計到 2025 年底，我們將擁有約 7.7 億美元的現金、現金等價物、受限現金和有價證券投資。總體而言，我們的核心業務實力雄厚，實現了有機成長，我們預計 2025 年將保持良好發展勢頭。

Thank you for joining the call today. Operator, now you may open it up for questions.

感謝您今天參加電話會議。接線員，現在您可以開始提問了。

Thank you. And I'll be conducting a question-and-answer session. (Operator Instructions)

謝謝。我將主持問答環節。（操作員指示）

Lu Li, UBS.

盧莉，瑞銀。

Great. Thank you for taking my question and congrats on the quarter. I guess maybe on the guidance, the $10 million increase for full year, how much to start from the Q2 bit versus the second half improvement. And then specifically, I think there was a $7 million increase in Precision Diagnostics. I was wondering if that is coming out from the VA contract or the Foundation Medicine partnership.

偉大的。感謝您回答我的問題，並祝賀本季取得佳績。我想也許根據指導，全年增加 1000 萬美元，從第二季開始與下半年的改善相比是多少。具體來說，我認為 Precision Diagnostics 的銷售額增加了 700 萬美元。我想知道這是來自 VA 合約還是 Foundation Medicine 合作夥伴關係。

Yeah. Thank you for the question. Brandon, do you want to talk about the strength in our Laboratory Services business and the reason why we're raising the outlook?

是的。謝謝你的提問。布蘭登，您想談談我們的實驗室服務業務的優勢以及我們提高前景的原因嗎？

Yes, certainly, I can do that. And thanks, Lu, for the question. In regard to the $7 million improvement in Precision Diagnostics, yes, the VA did play some role in that. We've had a great working relationship thus far with the VA. We actually see that relationship expanding. We've done a lot of different tests for the VA. We've done great with turnaround time and quality implementation. There's actually some opportunity to expand that into some further areas of genetic testing.

是的，當然可以。謝謝 Lu 提出這個問題。關於精準診斷 (Precision Diagnostics) 700 萬美元的改進，是的，退伍軍人事務部 (VA) 確實在其中發揮了一定作用。到目前為止，我們與 VA 保持著良好的合作關係。我們確實看到這種關係正在不斷擴大。我們為 VA 做了很多不同的測試。我們在周轉時間和品質實施方面做得很好。實際上，我們有機會將其擴展到基因檢測的其他領域。

So -- but in terms of Foundation Medicine, a very strong partnership, really happy to be aligned with them to promote our products in parallel. The revenue for the quarter was not material, but we see that relationship strengthening. We see the go-to-market strategy improving. We think there could be some additional upside around that this year, but a little bit slower than we anticipated, but it's a big partnership to get off the ground.

所以 — — 但就 Foundation Medicine 而言，這是一個非常強大的合作夥伴關係，很高興能與他們合作，同時推廣我們的產品。本季的收入並不重要，但我們看到這種關係正在加強。我們看到市場進入策略正在改善。我們認為今年可能會有一些額外的好處，但速度比我們預期的要慢一些，但這是一個需要大力推動的重大合作。

But the -- in addition to those two, Lu, we saw strength across many different areas of our Precision Diagnostics portfolio whether that's hereditary cancer, Beacon Expanded Carrier Screening, a little bit of KNOVA NIPT volume. But overall, I mean, just the Precision Diagnostics business performed very well in the quarter.

但是 — — 除了這兩個之外，Lu，我們還看到了精準診斷產品組合在許多不同領域的優勢，無論是遺傳性癌症、Beacon 擴展攜帶者篩檢，還是一點點 KNOVA NIPT 量。但整體而言，精準診斷業務在本季表現非常出色。

Great. And then my second question on the AP. It seems like pretty strong in the quarter. I was wondering if there was anything like a onetime dynamic that we should think about, given that your guidance or just like the second half will be slower. I just want to make sure that I understand the dynamic within AP.

偉大的。接下來是我的第二個問題，關於美聯社。本季看起來表現相當強勁。我想知道，在您的指導下，我們是否應該考慮一次性動態之類的東西，或者就像下半場會更慢一樣。我只是想確保我了解 AP 內部的動態。

Yeah. Brandon, do you want to talk about the strength in our Anatomic Pathology?

是的。布蘭登，你想談談我們的解剖病理學的優勢嗎？

Yeah, absolutely. Lu, yeah, there's really no one-time event in the quarter. I think for a couple of quarters now, we said we've been pretty happy with the turnaround we've made there. The lab has done an excellent job with quality and turnaround time and EMR integrations. And I think the biggest thing we've done there is improve and expand that sales organization.

是的，絕對是如此。盧，是的，本季確實沒有一次性事件。我認為，在過去的幾個季度裡，我們對所取得的轉變感到非常滿意。該實驗室在品質、週轉時間和 EMR 整合方面做得非常出色。我認為我們所做的最重要的事情就是改善和擴大銷售組織。

The growth you're seeing in AP is purely organic growth. It's blocking and tackling. It's winning new deals. The AP team has excellent sales leadership and has an excellent team that is much bigger today than it was a year or two ago. So it's pure execution from both the lab and the sales team and we're quite excited to see that AP business turn around and hit a really nice stride in terms of growth.

您在 AP 中看到的成長純粹是有機成長。這是阻擋和鏟球。它正在贏得新的交易。AP 團隊擁有出色的銷售領導力，並且擁有一支優秀的團隊，如今的團隊規模比一兩年前要大得多。因此，這是實驗室和銷售團隊的純粹執行，我們很高興看到 AP 業務出現好轉並在成長方面取得了非常好的進展。

Got it. Final question for Paul. So on the gross margins, 44%, it seems like there's some onetime adjustment there. I was wondering if you're excluding that, what will be the kind of organic gross margin for the quarter?

知道了。最後一個問題問保羅。因此，就 44% 的毛利率而言，似乎存在一些一次性調整。我想知道，如果不考慮這一點，本季的有機毛利率會是多少？

Yeah, that's an excellent question. So we're really pleased with the bump that we saw in our gross margins. About half of the increase was due to a onetime accounting adjustment that we had in there. But the other half is due to the overall strength in our business combined with the continued efficiency that we see in the operations of our Laboratory Services business.

是的，這是一個很好的問題。因此，我們對毛利率的成長感到非常高興。大約一半的成長是由於我們進行了一次性會計調整。但另一半則歸功於我們業務的整體實力以及我們在實驗室服務業務運作中看到的持續效率。

Great. Thank you.

偉大的。謝謝。

Thank you, Lu.

謝謝你，盧。

David Westenberg, Piper Sandler.

大衛‧韋斯滕伯格、派珀‧桑德勒。

Hey, I thanks for taking the question and congrats on the color there. Just a follow-up from Lu's question on Anatomic Pathology. I think you did say 11% growth. That is a really good number. When you talked about the new sales force, were you able to enter new geographies that -- and if that's the case, is there any other new geographies that you have an opportunity to get into to keep growing that Anatomic Pathology business?

嘿，感謝您提出這個問題，並祝賀您獲得這個顏色。這只是對 Lu 關於解剖病理學問題的後續回答。我認為你確實說過成長 11%。這確實是一個好數字。當您談到新的銷售團隊時，您是否能夠進入新的地區？如果是這樣，是否有其他新地區可以讓您有機會進入，以繼續發展解剖病理學業務？

Hey David, it's Brandon. Thanks for the question. And yes, you nailed it. We did put new salespeople in new geographies. I think we've mentioned a few times that our managed care contracts are very strong and they're national managed care contracts. That gives us a ton of green grass to go out there and hunt in.

嘿，大衛，我是布蘭登。謝謝你的提問。是的，你成功了。我們確實在新的地區部署了新的銷售人員。我想我們已經提到過幾次了，我們的管理式醫療合約非常強大，而且是全國性的管理式醫療合約。這給我們提供了大量的綠草，讓我們可以出去打獵。

So the sales team historically has been subscale. There's been a lot of territories that were not covered, but there's AP opportunities plentiful across the country. So the focus has been hiring really good salespeople that can hit the ground running and putting them in territories where we either don't have reps or don't have growth consistent with other sales territories. So again, it's not super flashy.

因此，從歷史上看，銷售團隊的規模一直較小。雖然還有很多地區尚未覆蓋，但全國各地都有大量的 AP 機會。因此，我們的重點是聘請真正優秀的銷售人員，讓他們能夠立即投入工作，並將他們安排到我們沒有銷售代表或與其他銷售區域沒有同步成長的區域。所以再說一遍，它並不是特別華麗。

It's blocking and tackling, hiring the right people, putting them in the right geographies and then giving them a product and a service that they can successfully sell. It's turnaround time, quality, the quality of our subspecialty trained pathologists. I think we put all of that together, we have an AP business that is growing and will continue to grow throughout the rest of the year.

它是一種阻礙和解決問題的方法，僱用合適的人才，將他們安置在合適的地區，然後為他們提供可以成功銷售的產品和服務。這是周轉時間、品質以及我們接受過專科培訓的病理學家的品質。我認為，將所有這些結合起來，我們的 AP 業務正在成長，並將在今年剩餘時間內繼續成長。

Thanks. And Brandon, on -- you gave a lot of color on your rare disease offering. You mentioned the AAP guidelines. How are you going to go after that channel? Is this going to be -- I know you have experience at Baylor, for example. So is this going to be outpatient? Are you going to see this a little bit more in the NICU? Is it kind of all of the above?

謝謝。布蘭登，您對罕見疾病治療做出了非常詳細的介紹。您提到了 AAP 指南。您打算如何處理該頻道？這會是——例如，我知道你在貝勒大學有經驗。那麼這是門診嗎？您會在新生兒加護病房 (NICU) 中看到更多這種情況嗎？以上都是這種情況嗎？

And can you talk about some of the synergies you might have with the -- going after existing hospital systems or any kind of sales pull-through with reproductive health, and I guess it wouldn't be obstetricians, but pediatrics.

您能否談談您可能產生的一些協同效應——追求現有的醫院系統或任何形式的生殖健康銷售，我想這不是產科醫生，而是兒科醫生。

Yeah, certainly. Look, I think the take-home message is the momentum in exome and genome. More and more societies are endorsing this test as a frontline test. We've seen the value of getting to a diagnosis earlier in these patient journeys, putting these types of tools in the hands of practitioners. And of course, that helps with insurance coverage and reimbursement as well. So I mean, I think that's the major takeaway is exomes and genomes are going to continue to grow as the utilization increases and families and patients are going to benefit from it.

是的，當然。瞧，我認為最重要的訊息是外顯子組和基因組的發展動能。越來越多的社會認可這項測試作為一線測試。我們已經看到了在患者就診過程中儘早做出診斷的價值，並將這些類型的工具交給醫生。當然，這也有助於保險覆蓋和報銷。所以我的意思是，我認為主要的收穫是隨著利用率的提高，外顯子組和基因組將繼續增長，家庭和患者將從中受益。

I think the move of AAP to endorse this for their pediatrics is great. How do you penetrate that market, it's a more fragmented market, right? When we talk about children's hospitals or academic medical centers, it's a more concentrated call point. So perhaps we might need larger sales team, if we really want to go after the pediatrics market. Certainly, the academic medical centers and children's hospitals are the main call point.

我認為 AAP 為兒科提供此項支持的舉措非常棒。您如何滲透這個市場？這是一個更分散的市場，對嗎？當我們談論兒童醫院或學術醫療中心時，它是一個更集中的呼叫點。因此，如果我們真的想進軍兒科市場，也許我們需要一個更大的銷售團隊。當然，學術醫療中心和兒童醫院是主要的呼叫點。

I think what we've done in parallel with these improved recommendations from these societies is build a really, really good service in parallel. Our new whole genome with RNA is a great service. We are seeing a significant increase in diagnostic yield when we moved over to this new whole exome with RNA. We'll hopefully be presenting some of these data, but we're seeing improved detection rates of 10%, 15% over our previous version.

我認為，我們根據這些協會提出的改進建議所做的工作就是同時建立一個非常非常好的服務。我們的全新全基因組帶有 RNA 的是一項偉大的服務。當我們轉向使用 RNA 的這種新的全外顯子組時，我們看到診斷產量顯著增加。我們希望能夠展示其中的一些數據，但我們發現檢測率比之前的版本提高了 10% 到 15%。

So we're helping a lot more families. So we're encouraged to see the momentum in genomic sequencing and we intend to continue to invest in our capabilities as well as our sales team to gain market share while this service grows.

因此我們正在幫助更多的家庭。因此，我們很高興看到基因組定序的發展勢頭，我們打算繼續投資於我們的能力以及我們的銷售團隊，以在該服務增長的同時獲得市場份額。

Perfect. Then just one last on FID-007, I think you said enrolling this year and then reading out next year. Is there anything that would hold up the enrollment for this year? And as we're thinking about the readout in 2026, what could impact the time lines there as well? Thank you.

完美的。然後關於 FID-007 只剩下最後一點，我想您說的是今年入學，然後明年宣讀。有什麼因素會阻礙今年的招生嗎？當我們考慮 2026 年的讀數時，什麼也會影響那裡的時間軸？謝謝。

All right. David, thank you for the question. I think that we expect to accelerate the enrollment during the second half of the 2025. Previously, we excluded the patients pretreated with paclitaxel. But with the current enrollment and the data we've seen, the safety data we've seen from the first 32 patients, we felt we could open up for the patients who are previously treated with the paclitaxel could be also enrolled into our program. So we are broadening the pool.

好的。大衛，謝謝你的提問。我認為我們預計在2025年下半年加速招生。先前，我們排除了曾接受紫杉醇治療的患者。但根據目前的招募情況和我們看到的數據，以及從前 32 名患者身上看到的安全數據，我們覺得我們可以為之前接受過紫杉醇治療的患者開放，讓他們也可以加入我們的計畫。因此，我們正在擴大選擇範圍。

The another area where we've seen an encouragement from the NCI line is the patients previously treated with pembro who becomes the -- use the maintenance therapy as the first line. So we're in a good position for the head and neck cancer patients whoever they progressed with pembro treatment, they can get into our treatment options right away. So we see all the positive signs in that area.

我們從 NCI 線看到鼓勵的另一個領域是以前用過 pembro 治療的患者，他們成為使用維持療法作為第一線治療的患者。因此，對於頭頸癌患者來說，無論他們接受派姆治療後病情如何，我們都能立即為他們提供治療選擇。因此，我們看到了該地區的所有積極跡象。

Thank you so much.

太感謝了。

Thank you, David.

謝謝你，大衛。

Andrew Cooper, Raymond James.

安德魯庫柏、雷蒙詹姆斯。

Hey, everybody, thanks for the time. Thanks for the questions. Maybe just first, I want to kind of dig in a little bit more on some of the comments around AP and the guide there. It looks like you are kind of pointing to a little bit lower-dollar revenues in the back half on a quarterly basis.

嘿，大家，謝謝你們的時間。謝謝你的提問。也許首先，我想更深入地了解一些有關 AP 及其指南的評論。看起來您似乎在指出下半年的季度收入會略有下降。

Is anything changing there? Is there anything informing that? Is it a little bit of seasonality, a little bit of conservatism? Just help us think about the trends after what was a really good quarter in AP at least versus our outlook.

那裡有什麼變化嗎？有什麼東西可以告知這一點嗎？這是否帶有一點季節性，或者一點保守主義？只需幫助我們思考一下 AP 至少在經歷了一個非常好的季度之後的趨勢與我們的展望相比如何。

Yeah. Thanks. Again, I think we're really pleased to see that business return to growth. It's -- we do see some seasonality in the back half of the year, especially around sort of dermatological procedures. So if you think about the last half of the year, there's a lot of elective surgeries and biopsies that may be pushed past the holiday season, for example. But who knows? With the progress we're making in some of the new wins, we might be able to outpace some of that seasonality.

是的。謝謝。再次，我認為我們真的很高興看到業務恢復成長。我們確實看到了下半年的一些季節性，特別是在皮膚病學手術方面。因此，如果你考慮今年下半年的情況，你會發現有很多選擇性手術和活檢可能會被推遲到假期之後。但誰知道呢？隨著我們在一些新勝利中取得的進展，我們可能能夠超越一些季節性因素。

I think when we take a look at the pipeline and the opportunities, I mean, there's significant strength there. So I mean, it does slow down a bit in the back half of the year. But I think there's some potential upside if these pipelines come to fruition, that could potentially outpace the seasonality. But that's essentially what you're seeing is that slowdown into the late Q3 and Q4.

我認為，當我們審視通路和機會時，就會發現那裡有顯著的優勢。所以我的意思是，今年下半年它確實會放緩一點。但我認為，如果這些管道能夠實現，就會有一些潛在的上升空間，可能會超過季節性。但這基本上就是你所看到的，即第三季末和第四季的經濟放緩。

Andrew, this is Paul. We don't really anticipate that much softness. I mean, first of all, we're very, very happy with the increase in the results in the second quarter in our AP business. I think if you take a look at the initiatives in marketing and the expansion of the sales organization, you see that investment in the operating expenses. The selling and marketing, that's gone from $8.5 million to $12.3 million.

安德魯，這是保羅。我們確實沒有預料到會有那麼大的軟化。我的意思是，首先，我們對第二季 AP 業務業績的成長感到非常非常高興。我認為，如果你看一下行銷舉措和銷售組織的擴張，你會看到對營運費用的投資。銷售和行銷費用從 850 萬美元增加到了 1230 萬美元。

We think that investment, as Brandon mentioned, was very much needed and we're going to get more aggressive in expanding that sales organization. So we anticipate elevated numbers in Q3 and Q4. But as Brandon mentioned, they can even be better than what we anticipated. So we're optimistic about the AP business. But at the same time, we want to be a little cautious to take that increase and then project that out into Q3 and Q4 until it materializes.

正如布蘭登所說，我們認為非常需要投資，我們將更積極擴大銷售組織。因此我們預計第三季和第四季的數字將會上升。但正如布蘭登所說，它們甚至可能比我們預期的更好。因此我們對 AP 業務持樂觀態度。但同時，我們希望對這一增長保持謹慎，然後將其預測到第三季度和第四季度，直到實現。

Okay. Helpful. And then maybe another kind of a high-level question about the trends here. If we go back to some of the acquisitions, there was talk about rolling contracts through to the broader organization and some of the advantages there. You talked about the managed care wins that you've had since the start of this year.

好的。很有幫助。然後也許還有另一個關於這裡趨勢的高級問題。如果我們回顧一些收購，就會發現有關於將合約轉移到更廣泛的組織以及其中的一些優勢的討論。您談到了自今年年初以來管理式醫療所取得的勝利。

How has that played out in terms of kind of apples-to-apples AST versus giving you the opportunity to win incremental volume? Just would love how those dynamics have driven the numbers and informed the increased guide here weather more price, more volume and kind of how it's performed versus expectations?

就同​​類 AST 而言，與為您提供贏得增量機會相比，這有何影響？只是想知道這些動態如何推動數字並告知增加的指南，這裡的天氣是更多的價格，更多的數量以及它的表現與預期相比如何？

Thanks for the question. Look, I think overall, a strong managed care division and strong contracts helps with your go-to-market strategy. Clinicians nowadays do not like using out-of-network laboratories. We've seen out-of-network cost share increase over the years significantly when we look at out-of-network deductible co-pays and co-insurance. So the more patients we can have under our in-network umbrella, the better our go-to-market strategy is.

謝謝你的提問。看起來，我認為總體而言，強大的管理式醫療部門和強大的合約有助於您的市場進入策略。如今，臨床醫生不喜歡使用網路外的實驗室。當我們查看網絡外免賠額共同支付和共同保險時，我們發現網絡外成本份額多年來大幅增加。因此，我們的網路覆蓋的患者越多，我們的行銷策略就越好。

So I think we're incredibly strong in that area. We've added significant coverage this year. I know we haven't updated you much in the past, but we have made a lot of progress, so we thought it was a good time for that update. And our intention is to continue to get these contracts continue to expand our in-network coverage because that is an important part of the sales cycle, the go-to-market strategy. Clinicians want labs to be in-network, so patients can take advantage of their in-network co-pay coinsurance and deductible.

所以我認為我們在該領域非常強大。今年我們增加了大量報導。我知道我們過去沒有向您更新太多信息，但我們已經取得了很大進展，所以我們認為現在是更新的好時機。我們的目的是繼續獲得這些合同，繼續擴大我們的網路覆蓋範圍，因為這是銷售週期、市場進入策略的重要組成部分。臨床醫生希望實驗室在網路內，這樣患者就可以利用網路內共同支付的共同保險和免賠額。

But in addition to the go-to-market strategy, as Brandon mentioned, a strong RCM and reimbursement team with the additional volume we experienced efficiency and better realization, which I think that you'll continue to see in the performance of our gross margins.

但除了市場進入策略之外，正如布蘭登所提到的，強大的 RCM 和報銷團隊以及額外的業務量使我們體驗到了效率和更好的實現，我認為你會繼續在我們的毛利率表現中看到這一點。

Okay, great. I'll leave it there. Thanks, everybody.

好的，太好了。我就把它留在那裡。謝謝大家。

Thank Andrew.

謝謝安德魯。

Thank you. We've reached the end of our question-and-answer session. And ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.

謝謝。我們的問答環節已經結束。女士們、先生們，今天的電話會議和網路直播到此結束。此時您可以斷開線路並享受美好的一天。我們感謝您今天的參與。