Fulgent Genetics Inc (FLGT) 2025 Q1 法說會逐字稿

Greetings, and welcome to the Fulgent Genetics Q1 2025 conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Fulgent Genetics 2025 年第一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 turn the call over to Melanie Solomon, Investor Relations. Please go ahead.

現在我很高興將電話轉給投資者關係部門的梅蘭妮·所羅門 (Melanie Solomon)。請繼續。

Thank you, Kevin. Good morning, and welcome to the Fulgent's first-quarter 2025 financial results conference call. On the call are Ming Hsieh, Chief Executive Officer; Paul Kim, Chief Financial Officer; and Brandon Perthuis, Chief Commercial Officer.

謝謝你，凱文。早上好，歡迎參加 Fulgent 2025 年第一季財務業績電話會議。參加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.

本公司關於財務表現的新聞稿可在本公司網站ir.fulgentgenetics.com的「投資者關係」板塊查閱。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」板塊提供。

Management's prepared remarks and answers to your questions on today's call will contain forward-looking statements. These forward-looking statements represent management 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.

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。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 of 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. Please review the more detailed discussions related to these forward-looking statements, including the discussions 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.

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對未來事件的預測，而應在聽取管理層今天的言論的同時，理解實際事件（包括公司未來的實際結果）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。請查看與這些前瞻性聲明相關的更詳細討論，包括對可能導致結果與前瞻性聲明中描述的結果不同的一些風險因素的討論，這些討論包含在公司向美國證券交易委員會提交的文件中，包括之前提交的截至 2024 年 12 月 31 日的 10-K 報表，以及隨後提交的報告，這些報告可在公司的投資者關係網站上查閱。

Management's prepared remarks, including discussions of 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（包括對收益和每股盈餘的討論）包含未依照美國公認會計原則（或 GAAP）編製的財務指標。管理階層之所以提出這些非 GAAP 財務指標，是因為其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按照 GAAP 編制的財務結果。

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

請參閱公司關於 2025 年第一季度財務業績的新聞稿，以獲取更多信息，包括公司如何計算非 GAAP 損益、每股收益或虧損、非 GAAP 毛利、非 GAAP 毛利率、非 GAAP 營業損益和利潤率以及調整後 EBITDA 的說明，以及這些財務指標與最直接收益和收益的 GAAP 財務收益可比的 GAAP 財務收益。

With that, I'd now like to turn the call over to Ming.

說完這些，我現在想把電話轉給 Ming。

Thank you, Melanie. Good morning, and thank you for joining our call today. I will start with some comments on the first 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，梅蘭妮。早安，感謝您今天參加我們的電話會議。我將首先對 2025 年第一季和我們的兩條業務線發表一些評論。然後，布蘭登 (Brandon) 將回顧我們的實驗室服務業務的產品和上市更新，保羅 (Paul) 將在我們回答您的問題之前總結財務和前景。

We are pleased with our first-quarter results, having shown year-over-year growth in Laboratory Services, and we are seeing great, good momentum in 2025. Our Therapeutic Development pipeline is on track. For our first clinical candidate, FID-007, our Phase 2 clinical trial, in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma, is progressing well, with 17 patients receiving treatment and 23 enrolled. We'll continue to enroll patients throughout this year. We'll continue to project the clinical trial cost of Phase 2 to be approximately $10 million over a multiple-year period.

我們對第一季的業績感到滿意，實驗室服務業務年增，我們預計 2025 年將呈現良好的發展勢頭。我們的治療開發流程進展順利。對於我們的第一個臨床候選藥物 FID-007，我們與西妥昔單抗聯合治療復發性或轉移性頭頸部鱗狀細胞癌患者的 2 期臨床試驗進展順利，已有 17 名患者接受治療，23 名患者入組。我們今年將繼續招募患者。我們將繼續預測第二階段臨床試驗的成本在多年內約為 1000 萬美元。

Our second clinical candidate, FID-022, is set to begin a Phase 1 trial over the next few weeks. FID-022 is a nano-encapsulated SN38 for treatment of solid tumors, including, potentially, colon, pancreatic, ovarian, and bile duct cancers. We'll continue to expect the clinical trial cost of Phase 1/1b trial for FID-022 to be approximately $8 million.

我們的第二個臨床候選藥物 FID-022 將在未來幾週內開始第一階段試驗。FID-022 是一種奈米封裝的 SN38，用於治療實體腫瘤，包括結腸癌、胰臟癌、卵巢癌和膽管癌。我們將繼續預期 FID-022 1/1b 期臨床試驗的成本約為 800 萬美元。

I'm encouraged by the continued progress with our clinical pipeline and the potential for both FID-007 and FID-022. We are targeting heavily pre-treated patients with a few options left. I hope we'll be able to provide additional treatment options to further their lives. We anticipate the cost of this program 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。我們的目標患者是已經接受過大量治療但只剩下少量治療選擇的患者。我希望我們能夠提供更多的治療選擇來延長他們的生活。我們預計該計劃的成本非常合理，並且我們相信我們的投資將獲得回報。

As a reminder, our drug candidates were formulated with our novel nano-encapsulation technology, which includes many issued or active patent applications, and with a therapy platform designed to improve therapeutic windows and pharmacokinetics profile for both new and existing cancer drugs. Overall, I'm pleased with our strong start to the year in our core Laboratory Services business and the progress we're making with our Therapeutic Development pipeline. We continue to be in a strong financial position to execute our strategy.

提醒一下，我們的候選藥物是採用我們的新型奈米封裝技術配製的，該技術包括許多已發布或有效的專利申請，並且採用旨在改善新舊抗癌藥物的治療窗口和藥物動力學特徵的治療平台。總體而言，我對我們核心實驗室服務業務今年的強勁開局以及治療開發管道所取得的進展感到滿意。我們繼續保持強勁的財務狀況來執行我們的策略。

I would 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 2025.

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年會取得更大進步。

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

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

Thanks, Ming.

謝謝，明。

It was a great quarter with all three business areas showing year-over-year growth. At a high level, Precision Diagnostics was up $6.7 million, or 17.8%, year over year. Anatomic Pathology was up $2.2 million, or 9.5%, year over year, and BioPharma Services was up $1.4 million, or 51.3%, year over year. Precision Diagnostics was up 1.2% sequentially, while Anatomic Pathology was down approximately 3.9% sequentially. BioPharma, coming off a record fourth quarter, was down 33.7% sequentially, but as we have mentioned, this is expected due to the nature of this business and timing of the contracts.

這是一個出色的季度，三個業務領域均實現了同比增長。從高點來看，Precision Diagnostics 的營收年增 670 萬美元，成長 17.8%。解剖病理學年增 220 萬美元，增幅 9.5%，生物製藥服務年增 140 萬美元，增幅 51.3%。Precision Diagnostics 環比上漲 1.2%，而 Anatomic Pathology 則是季減約 3.9%。生物製藥公司在第四季度創下了紀錄，環比下降了 33.7%，但正如我們所提到的，由於該業務的性質和合約的時間安排，這是可以預料到的。

The growth in Precision Diagnostics for the quarter was led by our reproductive health services, continued strength in our legacy diagnostics offerings, and Beacon Expanded Carrier Screening. We continue to pick up market share in this area by expanding our business with existing customers, as well as new client wins.

本季精準診斷業務的成長主要得益於我們的生殖健康服務、我們傳統診斷產品的持續強勁表現以及 Beacon 擴展帶因者篩檢。我們透過擴大與現有客戶的業務以及贏得新客戶來繼續獲得該領域的市場份額。

In previous calls, we announced two new initiatives: hereditary cancer testing with the VA and a partnership with Foundation Medicine. While both are still fairly new to us, we are very pleased with the progress. The sales team has done a great job onboarding new VA hospitals, and we are seeing significant usage. The focus will be to continue to sell through the contract and expand our footprint nationally.

在先前的電話會議中，我們宣布了兩項新舉措：與 VA 合作進行遺傳性癌症檢測以及與 Foundation Medicine 建立合作夥伴關係。儘管這兩者對我們來說都還比較新，但我們對進展感到非常滿意。銷售團隊在引進新的 VA 醫院方面做得非常出色，而且我們看到了顯著的使用率。我們的重點是繼續透過合約進行銷售並擴大我們在全國的影響力。

Regarding Foundation Medicine, we are seeing nice momentum onboarding clients, and the demand for hereditary cancer tests appears to be there. We are optimistic these initiatives will provide potential upside for us this year.

關於 Foundation Medicine，我們看到客戶入職勢頭良好，而且對遺傳性癌症測試的需求似乎也存在。我們樂觀地認為這些舉措將為我們今年帶來潛在的好處。

In terms of our Anatomic Pathology business, our laboratory continues to deliver excellent quality and turnaround time, and the improved sales team is doing a great job delivering this message to potential clients. Regarding the sales team, we continue to methodically hire, focused mostly on new expansion territories. I suspect this will continue into 2026.

就我們的解剖病理學業務而言，我們的實驗室繼續提供卓越的品質和周轉時間，而改進的銷售團隊在向潛在客戶傳遞這一訊息方面做得很好。關於銷售團隊，我們繼續有條不紊地招聘，主要專注於新的擴張領域。我懷疑這種情況將持續到 2026 年。

We've now posted back-to-back quarters of solid year-over-year growth, so it's exciting to see the investments we've made in this area paying off. One area to highlight in particular is the investment we have made in digital pathology. During the first quarter, we digitized over 85% of our slides and recognized over $1 million in digital billing for the first quarter. We believe we are significantly ahead of the curve in this area.

我們現在已經連續幾個季度實現了穩健的同比增長，因此看到我們在這一領域的投資獲得回報，我們感到非常興奮。特別值得強調的一個領域是我們在數位病理學方面的投資。在第一季度，我們將超過 85% 的幻燈片數位化，並確認第一季的數位帳單超過 100 萬美元。我們相信，我們在這一領域處於領先地位。

Moving to digital has several advantages, notably the ability to use AI to assist our pathologists, as well as providing our pathologists the option to read remotely. Remote reading has been huge for us since we can now recruit pathologists from all over the country without the need to relocate to one of our labs. With this new recruiting tool, we now work with over 60 pathologists, most of which are subspecialty trained. In terms of AI, now that most of our slides have been scanned, we can use commercially available AI and we are currently building our own AI tools, both of which have the potential to increase quality, turnaround time, and throughput.

轉向數位化有幾個優勢，特別是能夠使用人工智慧來協助我們的病理學家，以及為我們的病理學家提供遠端閱讀的選項。遠距閱讀對我們來說意義重大，因為我們現在可以從全國各地招募病理學家，而無需搬到我們的實驗室。透過這個新的招募工具，我們現在與 60 多名病理學家合作，其中大多數都接受過專科培訓。在人工智慧方面，現在我們的大部分投影片都已掃描完畢，我們可以使用商用人工智慧，而且我們目前正在建立自己的人工智慧工具，這兩者都有潛力提高品質、週轉時間和吞吐量。

Our BioPharma Services business continues to perform well and had an excellent quarter. We are seeing continued strength from existing clients, as well as a deepening pipeline of opportunities. We expect to see some variability from quarter to quarter based on the nature of this business, but with a vastly improved product offering, we believe we will continue to see demand for these services.

我們的生物製藥服務業務持續表現良好，並取得了出色的季度業績。我們看到現有客戶持續保持強勁成長勢頭，同時機會也日益豐富。根據該業務的性質，我們預計每個季度都會出現一些變化，但隨著產品供應的大幅改善，我們相信我們將繼續看到對這些服務的需求。

In previous calls, we discussed the potential for the FDA to regulate lab-developed tests, or LDTs. Recently, a district court ruling overturned the FDA's final rule on LDTs, and as a result, further regulatory efforts regarding LDTs may be unlikely in the near term. The court stated that, quote, the text, structure, and history of the Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments make clear that the FDA lacks the authority to regulate laboratory-developed tests. Although there is a possibility of an appeal, an appeal may be unlikely at this time for a variety of reasons. This is an evolving and fast-moving topic, so we will continue to monitor developments for the foreseeable future.

在先前的電話會議中，我們討論了 FDA 監管實驗室開發測試（LDT）的可能性。最近，地方法院的一項裁決推翻了 FDA 關於 LDT 的最終規定，因此，短期內不太可能對 LDT 採取進一步的監管措施。法院指出，《食品、藥品和化妝品法案》和《臨床實驗室改進修正案》的文本、結構和歷史明確表明，FDA 缺乏監管實驗室開發測試的權力。儘管有上訴的可能性，但由於各種原因，目前上訴的可能性不大。這是一個不斷發展且快速變化的議題，因此我們將在可預見的未來繼續監測事態發展。

We were pleased to see 2025 get off to a fast start, and we hope to see the momentum continue. We believe the investments we are making in our operation and business have paid off and should continue to do so.

我們很高興看到 2025 年快速起步，我們希望看到這種勢頭繼續下去。我們相信，我們在營運和業務上所做的投資已經獲得回報，並且應該繼續如此。

I'll now turn the call over to Paul Kim, our Chief Financial Officer. Paul?

現在我將把電話轉給我們的財務長 Paul Kim。保羅？

Thank you, Brandon.

謝謝你，布蘭登。

The revenue in the first quarter of 2025 totaled $73.5 million compared to $76.2 million in the fourth quarter of 2024. The revenue from COVID-19 testing is negligible. Revenues from our core business totaled $73.5 million. GAAP gross margin was 38.6% and on a non-GAAP basis was 41%. Gross margins improved year over year, showing the benefit of our continued efficiencies and streamlining of our business.

2025 年第一季的營收總計 7,350 萬美元，而 2024 年第四季的營收總計 7,620 萬美元。來自 COVID-19 檢測的收入微不足道。我們核心業務的收入總計 7,350 萬美元。GAAP 毛利率為 38.6%，非 GAAP 毛利率為 41%。毛利率逐年提高，反映了我們持續提高效率和精簡業務帶來的好處。

Now to operating expenses. Total GAAP operating expenses were $48.1 million in the first quarter compared to $48 million in the fourth quarter of 2024. Non-GAAP operating expenses totaled $37.4 million, remaining essentially flat compared to the fourth quarter of 2024. First-quarter operating expenses benefited from the reversal of $1 million previously accrued as a potential liability related to the SEC, since the SEC has advised the company that it has concluded its investigation with no enforcement action recommended. Non-GAAP operating margins decreased approximately 5 percentage points sequentially to a minus 10%, primarily due to lower revenue and gross margins.

現在談談營運費用。第一季的 GAAP 總營運費用為 4,810 萬美元，而 2024 年第四季為 4,800 萬美元。非公認會計準則營運費用總計 3,740 萬美元，與 2024 年第四季相比基本持平。第一季的營運費用受益於先前提列的與美國證券交易委員會相關的 100 萬美元潛在負債的沖銷，因為美國證券交易委員會已通知該公司其調查已經結束，且不建議採取執法行動。非公認會計準則營業利潤率季減約 5 個百分點至-10%，主要原因是收入和毛利率下降。

Adjusted EBITDA loss for the first quarter was approximately $2.9 million compared to a loss of $3.2 million in Q1 2024.

第一季調整後的 EBITDA 虧損約為 290 萬美元，而 2024 年第一季的虧損為 320 萬美元。

On a non-GAAP basis and excluding equity-based compensation expense and intangible asset amortization, income for the quarter was approximately $1.2 million, or $0.04 per share based on $30.9 million weighted average diluted shares outstanding.

以非公認會計準則計算，且不包括股權激勵費用和無形資產攤銷，本季收入約為 120 萬美元，或以 3,090 萬美元加權平均稀釋流通股計算每股收益 0.04 美元。

Since the beginning of 2025, as of today, we have repurchased approximately 646,000 shares at an aggregated cost of $10.9 million pursuant to our stock repurchase program. Since the inception of the 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.

自 2025 年初以來，截至今天，我們已根據股票回購計畫回購了約 646,000 股，總成本為 1,090 萬美元。自 2022 年 3 月回購計畫啟動以來，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 first quarter with approximately $814.6 million of cash, cash equivalents, restricted cash, and marketable securities.

轉向資產負債表。第一季結束時，我們擁有約 8.146 億美元的現金、現金等價物、受限現金和有價證券。

We are reiterating our outlook for 2025 provided in February we are guiding to core revenue, which is total Laboratory Services revenue for the company without COVID-19 testing revenue. We expect total core revenue to be approximately $310 million for 2025, representing a growth of 10% year over year. We continue to expect non-GAAP gross margins for the full year to slightly exceed 40%, continuing the strong momentum we've experienced in recent quarters. We continue to expect non-GAAP operating margins of approximately minus 15% for the year as we continue to invest in business growth, further develop laboratory operations, and enhance our existing laboratory facilities.

我們重申對 2025 年的展望，因為我們在 2 月指導了核心收入，即不包括 COVID-19 檢測收入的公司實驗室服務總收入。我們預計 2025 年核心總營收將達到約 3.1 億美元，年增 10%。我們繼續預計全年非公認會計準則毛利率將略高於 40%，延續近幾季的強勁勢頭。由於我們繼續投資於業務成長、進一步發展實驗室營運並增強現有實驗室設施，我們預計今年的非 GAAP 營業利潤率將繼續保持在約負 15% 的水平。

We remain focused on managing our spend and continue to believe that our foundational technology platform supports a strong margin profile longer term. We continue to expect associated cash burn for our Therapeutics Development business of approximately $25 million this year, which is contemplated in our EPS and cash guide. We continue to expect our GAAP EPS to be a loss of approximately $1.95 per share, excluding any future one-time charges, using a 32 million average share count. Utilizing a non-GAAP tax provision and average share count of 32 million, we currently expect full year 2025 to be at a non-GAAP loss of $0.65 per share, excluding stock-based compensation impairments and amortization of intangible assets, as well as any one-time charges.

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長期支持強勁的利潤率。我們預計今年治療開發業務的相關現金消耗將達到約 2500 萬美元，這已在我們的每股收益和現金指南中進行了預期。我們繼續預計，以平均股數 3,200 萬計算，我們的 GAAP EPS 將虧損約 1.95 美元/股（不包括任何未來的一次性費用）。利用非公認會計準則稅務準備金和 3,200 萬股平均股數，我們目前預計 2025 年全年非公認會計準則虧損為每股 0.65 美元，不包括股票薪資減損和無形資產攤銷以及任何一次性費用。

Finally, our cash position remains strong. We're focused on efficient capital allocation that allows us to reinvest in the business, fund key initiatives, and support future growth. Excluding any future stock repurchases and other expenditures outside the ordinary course, which could include M&A, we anticipate ending 2025 with approximately $770 million of cash, cash equivalents and investment, and marketable securities. The decrease from the previous estimate of $780 million relates to the $10.9 million spent year to date on stock repurchases. Overall, we see strength in our core business, which has grown organically, and we see good momentum in 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，以便我們能夠對業務進行再投資、資助關鍵計劃並支持未來的成長。不包括任何未來股票回購和其他正常業務以外的支出（可能包括併購），我們預計到 2025 年底，現金、現金等價物和投資以及有價證券約為 7.7 億美元。與先前估計的 7.8 億美元相比有所減少，因為今年迄今已花費 1,090 萬美元用於股票回購。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 年將呈現良好發展勢頭。

Thank you for joining us on our call today. Operator, now, you may open it up for questions.

感謝您今天參加我們的電話會議。接線員，現在您可以開始提問了。

(Operator Instructions) Lu Li, UBS.

(操作員指示) 瑞銀集團，陸力。

Thank you so much for taking my question. The first one is on the full-year guide. You mentioned the great momentum in the VA contract and the Foundation Medicine and you picked a quarter. So why not raise the guide? Do you think there are any more upsides or downsides to the '25 number?

非常感謝您回答我的問題。第一個是全年指南。您提到了 VA 合約和基礎醫學的巨大發展勢頭，並選擇了一個季度。那為什麼不提高指導價呢？您認為 25 這個數字還有什麼優點或缺點嗎？

Yeah. On the guide, I think your comment was on revenue, but I'll also cover EPS as well. Given the fact that we just initially had the guide about eight or nine weeks ago when we announced our year-end results, we actually see great momentum in our overall core business, particularly in the area of Precision Diagnostics. We just want to be a little bit more comfortable before we adjust the guide because when we do potentially make any adjustments to the revenue guide, we want that to be a bit considerable rather than something that's less than that.

是的。在指南中，我認為您的評論是關於收入的，但我也會涵蓋每股收益。考慮到我們在大約八、九週前宣布年終業績時才剛剛獲得指南，我們實際上看到了整體核心業務的強勁發展勢頭，特別是在精準診斷領域。我們只是希望在調整指南之前能更放心一些，因為當我們確實可能對收入指南進行任何調整時，我們希望調整幅度是相當大的，而不是低於這個數字。

And then on the EPS, as you see, we had a very good first quarter, and the EPS came in a bit better than what we internally estimated. But we also want the adjustment to the EPS to be something that's considerable when we do alter that. There's certainly a possibility that we can do that in the second quarter, but we're monitoring that.

然後就每股收益而言，如您所見，我們的第一季表現非常好，每股收益比我們內部估計的要好一些。但我們也希望，當我們確實改變每股盈餘時，對每股盈餘的調整是相當可觀的。我們當然有可能在第二季度做到這一點，但我們正在監控這一點。

The other thing on why we did not adjust the EPS guide at this point is because we had been a bit aggressive on our stock buyback. And the way the mechanics work on the stock buyback when you have losses is less shares that you have out there outstanding actually decreases your EPS. So we're actually monitoring those dynamics before we adjust the guide on both the top as well as the bottom line.

我們此時沒有調整每股盈餘指南的另一個原因是，我們在股票回購方面有些積極。當你遭受損失時，股票回購的機制是，流通股數減少實際上會降低每股盈餘。因此，在調整頂部和底部的指南之前，我們實際上正在監控這些動態。

Got it. Appreciate the color. So I think this question is for Brandon. I think in the last quarter, you mentioned that there are some of the new accounts that you ran in Precision Diagnostics flipped into 2025, so like Q1 and Q2. So I wonder, your Q1 result, how much of that is coming out from those new accounts where you already fully aborted them? And how much is actually the base Precision Diagnostics business, if that makes sense?

知道了。欣賞色彩。所以我認為這個問題是問布蘭登的。我想在上個季度，您提到過，您在 Precision Diagnostics 中運行的一些新帳戶已經轉移到 2025 年，例如第一季和第二季度。所以我想知道，您的第一季業績中，有多少來自那些您已經完全中止的新帳戶？那麼，基礎精準診斷業務的實際規模是多少呢？

I think it does. And thanks for the question.

我認為是的。感謝您的提問。

So I think the strong performance we had in the first quarter was certainly a mix of our existing clients ordering more from us, but probably more so new client wins. We continue to pick up market share in Precision Diagnostics, especially in the reproductive health arena. Yes, we've talked about new meaningful wins in previous quarters. And then onboarding early this year, we mentioned that some of these larger clients take some time to onboard to get implemented.

因此，我認為我們在第一季的強勁表現肯定是現有客戶向我們訂購更多訂單的結果，但可能更重要的是新客戶的成功。我們在精準診斷領域的市佔率持續上升，尤其是在生殖健康領域。是的，我們在前幾個季度談到了新的有意義的勝利。然後在今年年初加入時，我們提到其中一些較大的客戶需要一些時間來實施。

That's all happening in real time. So I think the strong performance we're seeing is Fulgent gaining additional market share in some of these areas with meaningful new client wins. Some of these new clients are still not fully onboarded. I mean, think about some of the very large practices and clinics throughout the country, it takes a while to onboard clinics when they have 20, 30, 50 clinics across the country.

這一切都是即時發生的。因此，我認為我們看到的強勁表現是 Fulgent 透過贏得有意義的新客戶在某些領域獲得了額外的市場份額。其中一些新客戶尚未完全加入。我的意思是，想想全國各地的一些大型診所，當他們在全國擁有 20、30、50 家診所時，需要一段時間才能讓診所加入。

So it's a bit of a rollout, and it just takes some time. But all that's progressing quite nicely, and I think we're going to continue to see that momentum pick up from new client wins.

所以這有點像是推廣，只是需要一些時間。但所有事情都進展得相當順利，我認為我們將繼續看到這種勢頭因贏得新客戶而回升。

Got it. So final question for me on capital deployment. Do you expect to doing more buyback in 2025? And how should we think about kind of like the M&A potential? Thank you.

知道了。所以我的最後一個問題是關於資本部署的。您預計 2025 年會進行更多回購嗎？我們該如何看待併購的潛力？謝謝。

Yes, thank you for the questions. Definitely you see we're starting to deploy capital for the stock buyback aggressively. In addition, we are evaluating various options for the potential M&A to enhance our distribution network and the deployed technologies. So all those options are open, and we'll actively review every deal we're seeing.

是的，謝謝你的提問。您肯定會看到，我們開始積極部署資金用於股票回購。此外，我們正在評估各種潛在的併購選擇，以增強我們的分銷網絡和部署的技術。因此，所有這些選擇都是開放的，我們將積極審查我們看到的每一筆交易。

David Westenberg, Piper Sandler.

大衛‧韋斯滕伯格、派珀‧桑德勒。

Hi. Thanks for taking the question. So actually, I'll start off -- Ming Hsieh, can you talk about the expected penetration rate once you launch FID-107? What do you expect the cadence of adoption, and can you remind us kind of is that a cancer with more broad-based chemotherapies or a lot more targeted?

你好。感謝您回答這個問題。那麼實際上，我首先要說的是——Ming Hsieh，您能談談推出 FID-107 後的預期滲透率嗎？您預期採用的節奏是怎樣的？您能否提醒我們，針對癌症的化療是更廣泛的還是更有針對性的？

Yeah, thank you for the question. It is by combination with cetuximab. We are targeting for the EGFR-positive patients, but it's also with our chemo option, we're also targeting non-EGFR populations together. The head and neck cancer is the initial restart, but many other options we could explore once we get concluded our dosing optimization in the Phase 2 trials. But overall, the result is good, and also the market is quite large for us.

是的，謝謝你的提問。它與西妥昔單抗聯合使用。我們的目標是 EGFR 陽性患者，但透過化療，我們也同時針對非 EGFR 族群。頭頸癌是最初的重新開始，但一旦我們在第二階段試驗中完成劑量優化，我們就可以探索許多其他選擇。但整體來說，結果還是不錯的，而且市場對我們來說也相當大。

Okay. Thank you. Paul, I want to actually talk about maybe the capital deployment, and you do have a lot of different products now and you do have pretty good efficiencies in the lab. Is there any thoughts to maybe using capital deployment to expand sales and marketing? I know that usually -- I know you said you guys are looking at tuck-ins and stock buybacks. Is there any opportunity you think in terms of expanding that?

好的。謝謝。保羅，我實際上想談談資本部署，你們現在確實有很多不同的產品，而且你們的實驗室效率也相當高。有沒有想過要利用資本部署來擴大銷售和行銷？我知道通常——我知道你們說過你們正在考慮收購和股票回購。您認為是否存在擴大此範圍的機會？

Yeah, that's an excellent question. So let me kind of tee that up, and then I'm going to turn it over to Brandon.

是的，這是一個很好的問題。讓我先開始討論這個問題，然後我會把它交給布蘭登。

If you take a look at our Q1 actual results, we talked about the reversal of the SEC so-called that we had in the G&A of $1 million. So you see the G&A being a bit lower than our normalized rate of $22 million to $23 million, excluding stock-based compensation. But to your question on the sales and marketing, that was also lower, meaning if you take a look at our sales and marketing spend, there was $7.6 million in Q1, but we see that being ramped up to between $10 million and $11 million in Q2, Q3, and Q4, respectively.

如果你看我們第一季的實際結果，我們談到了美國證券交易委員會 (SEC) 所謂的 100 萬美元 G&A 費用的逆轉。因此，您會看到，不包括股票薪酬，G&A 費用略低於我們的正常費率 2,200 萬美元至 2,300 萬美元。但對於您關於銷售和行銷的問題，這個數字也較低，這意味著如果您看一下我們的銷售和行銷支出，第一季為 760 萬美元，但我們發現第二季、第三季和第四季的支出分別增加到 1,000 萬美元至 1,100 萬美元之間。

And I'll turn it over to Brandon on why that is happening.

我將向布蘭登解釋為什麼會發生這種情況。

Yeah, certainly. Thanks again for the question, David.

是的，當然。再次感謝您的提問，大衛。

I mean, the short answer is yes, we are hiring. We're hiring in real time. We expect that to pick up some momentum throughout this year. We are hiring new salespeople for pediatric and rare disease testing. We're hiring new salespeople for reproductive health, and we're also hiring people in the Pathology division.

我的意思是，簡短的回答是，是的，我們正在招募。我們正在即時招募。我們預計今年這股勢頭將會有所增強。我們正在招募新的銷售人員進行兒科和罕見疾病檢測。我們正在招募生殖健康領域的新銷售人員，同時也招募病理學部門的人員。

We mentioned on the call we've done a great job turning the Pathology division around. We're seeing that division return to growth. That team is producing, able to take our great turnaround time and quality to market. So the short answer to your question, yes, we're going to be hiring salespeople across all three divisions throughout the rest of this year.

我們在電話中提到，我們在扭轉病理學部門的局面方面做得非常出色。我們看到該部門正在恢復成長。該團隊正在生產，能夠將我們出色的周轉時間和品質推向市場。所以對於你的問題，簡短的回答是，是的，我們將在今年剩餘時間內為所有三個部門招募銷售人員。

We believe in terms of our go-to-market strategy, our competitive advantages, our contracts that we now have, we have what it takes operationally to make this sales team successful. So we'll be updating future phone calls about the size of the team, how quickly it's growing, but we are excited about recruiting some really good talent here to come help grow the company.

我們相信，就我們的市場進入策略、我們的競爭優勢以及我們現有的合約而言，我們擁有使這個銷售團隊成功所需的營運條件。因此，我們將在未來的電話中更新團隊規模和發展速度，但我們很高興招募一些真正優秀的人才來幫助公司發展。

Very helpful. And yeah, you did have a good growth in Anatomic Pathology, which came as a surprise, good, obviously, positive.

非常有幫助。是的，你在解剖病理學方面確實取得了很大的進步，這很令人驚訝，顯然是好的，積極的。

Just in terms of strength in BioPharma, that one actually, I think that you guys were a little bit of an outlier in terms of the magnitude of how good that was. Just given the fact that BioPharma, at least from our polls, just seems to be a little bit more conservative in the current environment. Can you talk about appetite for spending the rest of the year? And maybe color on book-to-bill there, just the way we should expect in the rest of the year, because, I mean, I don't think you guys will be growing at 51% in the rest of the year. I just want to be careful about not getting over our skis in terms of the way we're thinking about that.

僅就生物製藥領域的實力而言，實際上，我認為你們在優秀程度方面有點異常。鑑於BioPharma，至少從我們的民調來看，在當前環境下似乎更保守一些。您能談談對今年剩餘時間的期望嗎？也許訂單出貨比會有所變化，就像我們在今年剩餘時間內所預期的那樣，因為，我的意思是，我認為你們在今年剩餘時間內的成長率不會達到 51%。我只是想小心，不要在我們思考這個問題的方式上出現失誤。

Yeah, certainly. I think we -- on each call, we've mentioned sort of the variability quarter to quarter in our BioPharma business, and that's a factor of two things. One is still a relatively low number compared to the size of some of our other divisions. And the nature of that business, as we win these awards, we do the work, deliver the product, it can be variable and we've used even lumpy in previous calls. We hope to continue to gain scale so some of that variability kind of smooths out over time, but as long as we're working with a relatively smaller number and we're winning big awards at different intervals throughout the year, you're going to continue to see some variability.

是的，當然。我認為，在每次電話會議中，我們都提到了生物製藥業務每季的變化，這是由兩個因素造成的。與我們其他一些部門的規模相比，「1」仍然是一個相對較低的數字。而這個業務的性質，當我們贏得這些獎項時，我們會開展工作，交付產品，它可能會發生變化，我們在之前的電話會議中甚至使用過不均勻的情況。我們希望繼續擴大規模，以便隨著時間的推移，一些變化會逐漸消除，但只要我們的工作數量相對較少，並且我們在全年的不同時間間隔贏得大獎，你就會繼續看到一些變化。

That said, I think we've mentioned that our BioPharma capabilities have vastly expanded from where they were a year or even two years ago. So I think some of the strengths that we're able to see is that a lot of these new services we've launched, we're able to then sell those to these BioPharma clients as well. So think back just a couple years ago, we were mostly focused on next-generation sequencing, so there was a lot of studies, a lot of RFPs, a lot of opportunities we couldn't address, but for the past couple of years, we've launched all these new platforms, so we're able to address a much larger market.

話雖如此，我想我們已經提到過，我們的生物製藥能力與一年甚至兩年前相比已經有了很大的擴展。因此，我認為我們能夠看到的一些優勢是，我們推出的許多新服務也能夠將其出售給這些生物製藥客戶。回想幾年前，我們主要專注於下一代定序，因此有很多研究、很多 RFP、很多我們無法解決的機會，但在過去的幾年裡，我們推出了所有這些新平台，因此我們能夠滿足更大的市場需求。

So that team continues to build a good pipeline of opportunities. I think our relationships with the BioPharma companies are deepening, meaning we're seeing more pull-through from existing clients. I think that's great. It's a good testament to our quality and what we're doing with some of these companies. So I think we'll see some variability quarter to quarter, but if you look at it over time, I think that's an area that's going to grow quite well for the company.

因此團隊將繼續建立良好的機會管道。我認為我們與生物製藥公司的關係正在加深，這意味著我們看到了來自現有客戶的更多拉力。我認為這很棒。這充分證明了我們的品質以及我們與其中一些公司的合作。所以我認為我們會看到每個季度都會有一些變化，但如果從時間來看，我認為這是公司將會很好成長的領域。

Thank you very much.

非常感謝。

Andrew Cooper, Raymond James.

安德魯庫柏、雷蒙詹姆斯。

Hey, everybody. Thanks for the questions. Maybe first, just was hoping you could unpack a little bit more of the Precision Diagnostics momentum, what's sort of being driven by NOVA versus Beacon, and then really outside of reproductive health as well, what you're seeing, whether it's in some of those rare disease or, frankly, some of those newer oncology offerings that you've rolled out over the last several quarters.

嘿，大家好。感謝您的提問。也許首先，只是希望您能夠更多地了解精準診斷的發展勢頭，NOVA 與 Beacon 相比有何不同，然後真正了解生殖健康之外的情況，無論是在一些罕見疾病中，還是坦率地說，在過去幾個季度推出的一些較新的腫瘤學產品中。

Yeah. Thanks for the question, Andrew. Yeah, a lot to unpack there. We have a lot of tests in Precision Diagnostics, so it can be a bit overwhelming. I'll get the easy one out of the way. NOVA's not contributing significantly at this point. We are seeing good feedback from the field. We are generating some volume. Even internationally, we're generating some volume, but NOVA wasn't the driver for the quarter.

是的。謝謝你的提問，安德魯。是的，有很多東西要解開。我們在 Precision Diagnostics 中有很多測試，因此可能會有點不知所措。我會把容易的那個解決掉。目前 NOVA 的貢獻並不大。我們看到了來自現場的良好回饋。我們正在產生一些數量。即使在國際上，我們也產生了一些銷量，但 NOVA 並不是本季的驅動力。

I think there was probably two areas to highlight out of all the different tests that we offer. Still probably continues to be Beacon. We've just done an excellent job with Expanded Carrier Screening. I think our average turnaround time for the first quarter was something like 11 days, which is just spectacular. The quality of Beacon, what we're doing with our bioinformatics to address the pseudogenes, the quality of our reports, we've just done an excellent job bringing that product to market. So our existing clients are ordering more, but more importantly, we're onboarding new clients and having new client wins for Beacon.

我認為，在我們提供的所有不同測試中，可能有兩個方面需要強調。可能仍會繼續成為 Beacon。我們剛剛在擴大攜帶者篩檢方面做得非常出色。我認為我們第一季的平均週轉時間大約是 11 天，這真是太棒了。Beacon 的品質、我們利用生物資訊學解決假基因的方法、報告的質量，我們在將產品推向市場方面做得非常出色。因此，我們現有的客戶正在訂購更多產品，但更重要的是，我們正在吸引新客戶並為 Beacon 贏得新客戶。

Probably the other area to highlight is sort of our what our core business was for a long time is pediatric rare disease. I believe on the fourth-quarter call, we talked about launching a new whole genome that would include RNA sequencing. We branded it RISE, RNA-Integrated Sequencing Evaluation. So we have added to that sales team in a small way so far. We plan to do additional hiring throughout the year.

可能要強調的另一個領域是我們長​​期以來的核心業務是兒科罕見疾病。我相信在第四季的電話會議上，我們討論了推出包括 RNA 定序在內的新全基因組。我們將其命名為 RISE（RNA 整合定序評估）。因此，到目前為止，我們已經小規模地擴充了銷售團隊。我們計劃全年進行額外招聘。

But that area of our business is doing well. The market is really receiving the message that for diagnostic dilemmas, undiagnosed genetic conditions, adding RNA to whole genome sequencing is a very powerful tool. So that sales team has done a great job approaching children's hospitals, academic medical centers to really present the benefit of adding RNA to a whole genome. I think we've mentioned that literature shows with RNA, we could diagnose up to 20% or 30% more patients. So we're seeing momentum in the rare disease space. We're investing in that area, and I think it's going to have good momentum for us throughout the rest of the year.

但我們該領域的業務表現良好。市場確實收到了這樣的訊息：對於診斷難題和未確診的遺傳疾病，將 RNA 添加到全基因組定序中是一種非常強大的工具。因此，銷售團隊在與兒童醫院、學術醫療中心的接觸中做出了巨大貢獻，真正展示了將 RNA 添加到整個基因組中的好處。我想我們已經提到過，文獻表明，透過 RNA，我們可以診斷出多達 20% 或 30% 的患者。因此，我們看到了罕見疾病領域的發展動能。我們正在對該領域進行投資，我認為它將在今年剩餘時間內為我們帶來良好的發展勢頭。

Perfect. And then maybe -- can I start going back to the P&L a little bit? I think, Paul, you commented on that sort of $10 million to $11 million ballpark each of the rest of the quarters for sales and marketing. I guess, one, why should that not be going up if you're talking about hiring kind of incrementally through the rest of the year? And then, could you also help us think about gross margin trajectories as you do have sort of an evolving mix with, Brandon, to your point, kind of a lot of different moving parts, a lot of different products that are contributing different amounts in a given quarter or for the full year?

完美的。然後也許──我可以稍微回顧一下損益表嗎？保羅，我認為你評論說，其餘每季的銷售和行銷預算大概在 1000 萬美元到 1100 萬美元之間。我想，首先，如果您談論的是在今年剩餘時間內逐步招聘，那麼為什麼不應該增加這個數字呢？然後，您能否幫助我們思考一下毛利率軌跡，因為您確實有一個不斷變化的組合，布蘭登，就您的觀點而言，有很多不同的活動部件，很多不同的產品，它們在特定季度或全年貢獻不同的金額？

Yeah. As far as the gross margin, back about a year ago, our hope was that we get close to 40%, but we actually overachieved that mark, I believe, in the fourth quarter of 2024. And as we take a look at 2025, even with the revenues, say, for Q1 being slightly lower than Q4, we actually feel pretty good with our gross margins. Gross margins, excluding stock-based comp, was running at 41% or maybe a little bit higher than 41%. And we don't really see any reason on why, everything being equal, that would dip that much. There's actually a pretty good chance that when we get towards the back half of this year, it might even increase from the gross margin target that we had.

是的。就毛利率而言，大約一年前，我們希望接近 40%，但我相信，我們在 2024 年第四季實際上已經超過了這個目標。展望 2025 年，即使第一季的營收略低於第四季度，但我們對毛利率仍然感到相當滿意。不包括股票薪酬的毛利率為 41% 或略高於 41%。我們確實不明白為什麼在其他條件相同的情況下，這個數字會下降那麼多。實際上，當我們進入今年下半年時，很有可能我們的毛利率甚至會高於我們設定的毛利率目標。

And then on the expenses for selling and marketing, I forgot the question that you had for selling and marketing. Was your question why the step up in Q --

然後關於銷售和行銷費用，我忘記了您關於銷售和行銷的問題。你的問題為什麼 Q--

You talked about the $10 million to $11 million, but you've talked about kind of more hiring happening through the course of the year. So why the sudden step-up and then sort of plateauing as opposed to something a little bit --

您談到了 1000 萬到 1100 萬美元，但您也談到了全年將有更多的招募。那麼，為什麼會出現突然上升，然後又趨於穩定，而不是稍微上升一點的情況呢？--

Okay. Because we are actively hiring in Q1 and a number of those people have already joined the company, it's going to be between $10 million and $11 million. That's our forecast in the last three quarters. So in Q2, it might be something closer to $10 million, and in Q4, it might be something closer to $11 million.

好的。由於我們在第一季積極招聘，其中許多人已經加入公司，因此薪酬將在 1000 萬美元至 1100 萬美元之間。這是我們對過去三個季度的預測。因此，在第二季度，這個數字可能接近 1000 萬美元，而在第四季度，這個數字可能接近 1,100 萬美元。

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。