Fulgent Genetics Inc (FLGT) 2023 Q4 法說會逐字稿

Greetings and welcome to the Fulgent Genetics fourth quarter and full-year 2023 conference call and webcast. (Operator Instructions)

歡迎來到 Fulgent Genetics 2023 年第四季和全年電話會議和網路廣播。（操作員說明）

I would now like to turn the conference over to your host, Melanie Solomon, Investor Relations for Fulgent Genetics. Please go ahead.

現在我想將會議交給主持人 Fulgent Genetics 投資者關係部門的梅蘭妮·所羅門 (Melanie Solomon)。請繼續。

Thank you. Good morning, and welcome to the Fulgent fourth quarter and full-year 2023 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。早上好，歡迎參加 Fulgent 第四季和 2023 年全年財務業績電話會議。參加電話會議的包括執行長謝明 (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, www.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.

該公司討論財務表現的新聞稿可在公司網站 www.fulgentgenics.com 的投資者關係部分查閱。電話會議結束後不久，公司網站的投資者關係部分將提供該電話會議的重播。

Management's prepared remarks and answers to your questions on today's call contain forward-looking statements. These forward-looking statements represent management's estimates based on current views 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好的評論和對您問題的回答包含前瞻性陳述。這些前瞻性陳述代表了管理階層基於當前觀點和假設的估計，這些估計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受到風險、不確定性和情況變化的影響，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 in what is prescribed in or implied by these forward-looking statements.

該公司不承擔更新今天可能做出的任何前瞻性聲明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，而應聽取管理層今天的言論，並理解實際事件（包括公司未來的實際結果）可能與這些前瞻性陳述中規定或暗示的內容存在重大差異看起來的陳述。

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, 2022 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中描述的結果不同的一些風險因素的討論，包括先前提交的截至2022年12 月31 日的年度10-K 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看。

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.

管理層準備好的評論，包括對收益和每股收益的討論，包含的財務指標並未按照美國普遍接受的會計原則（GAAP）準備。管理階層提出這些非公認會計原則財務指標是因為它認為它們可能出於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公認會計原則編制的財務績效。

Please see the company's press release discussing its financial results for the fourth quarter and full-year 2023 for more information, including a description of how the company calculates non-GAAP income or loss, earnings or loss per share, and adjusted EBITDA, and a reconciliation of these financial measures to income or loss and earnings per share or loss per share, the most directly comparable GAAP financial measures.

請參閱該公司關於 2023 年第四季度和全年財務業績的新聞稿，了解更多信息，包括公司如何計算非 GAAP 收入或虧損、每股收益或虧損以及調整後 EBITDA 的說明，以及這些財務指標與營收或虧損以及每股盈餘或每股虧損的調節，是最直接可比較的GAAP 財務指標。

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

說到這裡，我現在想把電話轉給小明。

Thank you, Melanie. Good morning and thank you for joining our call today. I will start with some comments on the fourth quarter and the year ended December 31, 2023, then Brandon will review our product and go-to-market updates from the fourth quarter and Paul will conclude with the financials and the 2024 outlook before we take your questions.

謝謝你，梅蘭妮。早安，感謝您今天加入我們的電話會議。我將首先對第四季度和截至2023 年12 月31 日的年度進行一些評論，然後布蘭登將審查我們的產品和第四季度的上市更新，保羅將在我們採取行動之前總結財務狀況和2024年展望你的問題。

We are pleased with our results in the fourth quarter with $70 million of total revenue. Due to our successful collection efforts, we recognized $4 million of revenue on previously billed COVID-19 tests. As you will see in our 10-K, we are now reporting our business in two segments: one, our laboratory service business, which we previously referred to as our clinical diagnostics business, and second, our therapeutic development business. We have renamed our clinical diagnostics business to better represent the inclusion of technical laboratory services and professional interpretation of lab results by licensed physicians. This will now be called laboratory service.

我們對第四季的業績感到滿意，總收入為 7,000 萬美元。由於我們成功的收集工作，我們在先前計費的 COVID-19 測試中確認了 400 萬美元的收入。正如您將在我們的10-K 中看到的那樣，我們現在將我們的業務分為兩個部分：一是我們的實驗室服務業務，我們之前將其稱為臨床診斷業務，二是我們的治療開發業務。我們已重新命名我們的臨床診斷業務，以更好地體現技術實驗室服務和執照醫師對實驗室結果的專業解釋。這現在稱為實驗室服務。

As a reminder, core revenue is the total laboratory service revenue from the company without COVID-19 test revenue. Fourth-quarter core revenue of $66 million was driven by the momentum in precision diagnostics and the better-than-expected revenue from anatomic pathology and the biopharma services. After raising full-year guidance twice in 2023, we outperformed the full year by $2 million in core revenue from the latest raise in guidance with a positive impact on margins and earnings.

提醒一下，核心收入是公司實驗室服務總收入，不含 COVID-19 測試收入。第四季核心收入為 6,600 萬美元，主要得益於精準診斷的發展勢頭以及解剖病理學和生物製藥服務的收入好於預期。在 2023 年兩次上調全年指引後，我們的核心收入較全年增長了 200 萬美元，這對利潤率和收益產生了積極影響。

Moving on our therapeutic development business, we are continuing to make good progress with Fulgent pharma. Our novel nanoencapsulation technology includes our 40 issued or active patents and active patent applications and a targeted therapeutic platform designed to improve therapeutic window and pharmacokinetic profile for both new and existing cancer drugs.

在我們的治療開發業務上，我們與 Fulgent Pharma 繼續取得良好進展。我們的新型奈米封裝技術包括 40 項已發布或有效的專利和有效的專利申請，以及旨在改善新藥和現有癌症藥物的治療窗和藥物動力學特徵的標靶治療平台。

Our lead drug candidate, FID-007, has shown promising results in clinical trials to date for the treatment of numerous cancers, including head and neck, ampullary, pancreatic, with manageable safety profile observed in trials performed to date. An abstract on preliminary head and neck cancer clinical trial results from our Phase 1b study has been submitted for the 2024 ASCO annual meetings which will be held in the second quarter. Our Phase 2 clinical protocol for the second line treatment of head and neck cancer has been accepted by the FDA, and we expect to enroll the first patients early in the second quarter of this year. We are excited about reaching these next milestones for pharma and bringing FID-007 to more patients in the clinical setting.

我們的主要候選藥物FID-007 迄今為止在治療多種癌症（包括頭頸癌、壺腹癌、胰腺癌）的臨床試驗中顯示出有希望的結果，並且在迄今為止進行的試驗中觀察到具有可控的安全性。我們 1b 期研究的頭頸癌初步臨床試驗結果摘要已提交給將於第二季度舉行的 2024 年 ASCO 年會。我們的頭頸癌二線治療的 2 期臨床方案已被 FDA 接受，我們預計將在今年第二季初招募第一批患者。我們很高興能夠實現製藥業的下一個​​里程碑，並將 FID-007 帶給更多臨床患者。

In addition, using the same nanodrug delivery platform, we are also advancing our second drug candidate, FID-002, a nanoencapsulated SN38 while we regularly and expect to file an IND, or investigational new drug application, by the end of the year, while irinotecan, a pro-drug for SN38, has been approved by the FDA for colon cancer treatment. Formulations used in active components in SN38 have not been successful in lab so far primarily due to poor drug solubility and toxicity safety issues. We believe our nanodrug delivery platform has the potential to address these challenges.

此外，使用相同的奈米藥物輸送平台，我們也正在推進我們的第二種候選藥物 FID-002，一種奈米封裝的 SN38，同時我們預計在年底前定期提交 IND 或研究性新藥申請，同時伊立替康是SN38 的前藥，已被FDA 核准用於結腸癌治療。SN38中活性成分的配方迄今尚未在實驗室取得成功，主要是由於藥物溶解度差和毒性安全問題。我們相信我們的奈米藥物傳輸平台有潛力應對這些挑戰。

On the R&D front, building up our clinically proven nanoparticle technology while also developing a next-generation antibody drug conjugate technology platform that could potentially prove even broader killing towards heterogeneous cancer cells than those ADC with bystander killing effects. Our ADC platform is not target dependent and thus could potentially be applied to many different targeted ADCs, particularly for new targets with low-antigen expression where existing ADC platforms have failed to show effectiveness.

在研發方面，我們建立了經過臨床驗證的奈米顆粒技術，同時也開發了下一代抗體藥物偶聯物技術平台，該平台可能比那些具有旁觀者殺傷作用的 ADC 更廣泛地殺死異質癌細胞。我們的 ADC 平台不依賴目標，因此有可能應用於許多不同的目標 ADC，特別是對於現有 ADC 平台未能顯示有效性的低抗原表達的新目標。

Overall, we believe we have been good stewards of cash and maintain a strong balance sheet with which to execute our strategy. I'd like to thank our employees, partners, and stakeholders for your loyalty during the past year. We look forward to a strong year in 2024 and capitalizing on the momentum we see ahead.

總體而言，我們相信我們一直是良好的現金管理者，並保持強大的資產負債表來執行我們的策略。我要感謝我們的員工、合作夥伴和利害關係人在過去一年中的忠誠。我們期待 2024 年表現強勁，並充分利用我們看到的未來​​勢頭。

I'll now turn the call over to Brandon Perthuis, our Chief Commercial Officer, to talk about our laboratory service business results during the fourth quarter. Brandon?

現在我將把電話轉給我們的首席商務官 Brandon Perthuis，討論我們第四季度的實驗室服務業務表現。布蘭登？

Thank you Ming. It was a solid year for Fulgent, slightly exceeding our overall core revenue guidance, ending the year at $262 million, shattering our 2022 record by $81 million, an increase of 44% year over year. These numbers exclude any COVID-19 testing revenue.

謝謝明。對 Fulgent 來說，這是堅實的一年，略高於我們的整體核心收入指引，年終收入達到 2.62 億美元，比 2022 年的記錄增加了 8,100 萬美元，年終收入達到 44%。這些數字不包括任何 COVID-19 檢測收入。

We hit many new company milestones in 2023, which I will reflect on momentarily. At a high level, precision diagnostics continues to be the main growth driver, and it's precision diagnostics where our technology shines the brightest. Precision diagnostics performed well in 2023, contributing $132 million to the business. The main product outperforming was our Beacon expanded carrier strain.

2023 年，我們實現了許多新的公司里程碑，我將立即對此進行反思。從高水準來看，精密診斷仍然是主要的成長動力，而精密診斷是我們技術最耀眼的地方。精準診斷在 2023 年表現良好，為業務貢獻了 1.32 億美元。表現出色的主要產品是我們的 Beacon 擴展載體菌株。

Beacon has proven to be a very well received product in the IVF space, offering gene content flexibility up to 787 genes and rapid turnaround time of approximately two weeks on average. In addition, using our in-house developed informatics, databases, and pipelines, we are able to deliver reliable detection rates in difficult genes such as pseudogenes or genes with high sequence homology.

Beacon 已被證明是 IVF 領域非常受歡迎的產品，提供高達 787 個基因的基因內容靈活性，並且平均週轉時間約為兩週。此外，利用我們內部開發的資訊學、資料庫和流程，我們能夠對假基因或具有高序列同源性的基因等困難基因提供可靠的檢測率。

Our mix of clients for carrier screening services at this time is mostly IVF clinics, as well as robust B2B partnerships. A few months ago, we announced the new Beacon 787 expanded carrier screening panel, and we recently followed that up with launching the new Beacon preconception panel. Beacon preconception includes an additional focus on manifesting carriers in mild disease compared to standard Beacon panels, making it a better fit for some clients working with gamete donors or in the IVF clinic. We see Beacon continuing to be an important growth driver in 2024 as a result of additional market shake-up as well as sales and R&D execution.

目前，我們提供攜帶者篩檢服務的客戶群主要是 IVF 診所，以及強大的 B2B 合作夥伴關係。幾個月前，我們宣布了新的 Beacon 787 擴展攜帶者篩檢小組，最近我們又推出了新的 Beacon 孕前小組。與標準 Beacon 組合相比，Beacon 預孕還額外關注輕度疾病的攜帶者，使其更適合一些與配子捐贈者或 IVF 診所合作的客戶。我們認為，由於額外的市場調整以及銷售和研發執行，Beacon 將繼續成為 2024 年重要的成長動力。

Recently, we announced a new partnership with Cooper Surgical, a global leader in fertility and women's health, to offer exclusive newborn genetic screening panels to core blood registry families. Utilizing our Picture Genetics platform, CBR, the largest private newborn stem cell bank in the world now offers a range of testing options to its families, including CBR Snapshot, which screens children for over 250 genes related to metabolic disorders, blood disorders, cancers, cardiovascular disorders, hearing loss, and vision loss. Snapshot focuses on screening for conditions where early detection provides actionable information and may be managed with medication, diet, or other therapies.

最近，我們宣布與生育和婦女健康領域的全球領導者 Cooper Surgical 建立新的合作夥伴關係，為核心血液登記家庭提供獨家新生兒基因篩檢組合。利用我們的 Picture Genetics 平台，世界上最大的私人新生兒幹細胞庫 CBR 現在為其家庭提供一系列測試選項，包括 CBR Snapshot，它可以篩檢兒童 250 多種與代謝紊亂、血液疾病、癌症、心血管疾病、聽力損失和視力損失。快照著重於篩檢疾病，早期檢測可以提供可操作的信息，並且可以透過藥物、飲食或其他療法進行管理。

Secondly, CBR Portrait screens children for over 600 genes covering everything in CBR Snapshot, along with additional genes related to hearing loss, actionable epilepsy, immunodeficiency, heart conditions, and neonatal diabetes. CBR Portrait includes more than twice as many genes as CBR Snapshot and may identify more rare causes of these conditions, and if negative, the results further reduce the likelihood that a patient has the conditions included on the test.

其次，CBR Portrait 對兒童進行 600 多個基因篩檢，涵蓋 CBR Snapshot 中的所有內容，以及與聽力損失、可訴癲癇、免疫缺陷、心臟病和新生兒糖尿病相關的其他基因。CBR Portrait 包含的基因數量是 CBR Snapshot 的兩倍以上，並且可以識別這些病症的更罕見原因，如果呈陰性，結果會進一步降低患者患有測試中包含的病症的可能性。

Lastly, CBR Landscape screens children for over 1,500 genes and more than 1,000 conditions, and include a pharmacogenetic component that identifies the potential for adverse reactions to more than 100 medications.

最後，CBR Landscape 對兒童進行了 1,500 多種基因和 1,000 多種病症的篩檢，其中包括可識別 100 多種藥物潛在不良反應的藥物遺傳學成分。

Switching to AP, while anatomic pathology is critical to our mission of being a one-stop shop for physicians and contributes meaningfully to our overall revenue, we are seeing some headwinds in the business. That said, we have recently expanded our commercial footprint, plan to continue to layer on new sales hires, and we are committed to growing the business. In addition, we are making significant investments in operations, digital pathology, and AI to improve our efficiency. We estimate seeing these investments beginning to pay off late in 2024.

轉向 AP，雖然解剖病理學對於我們成為醫生一站式服務的使命至關重要，並且對我們的整體收入做出了有意義的貢獻，但我們看到了業務中的一些阻力。也就是說，我們最近擴大了我們的商業足跡，計劃繼續聘用新的銷售人員，並且我們致力於發展業務。此外，我們還在營運、數位病理學和人工智慧方面進行了大量投資，以提高我們的效率。我們預計這些投資將在 2024 年底開始獲得回報。

Previously, we reported on pharma services when we provided a breakout of revenue. For clarity purposes, we have renamed this breakout of revenue to bio pharma services to include any revenue related to clinical testing for pharma, biotech, CRO, or research organizations, of which approximately $4 million had been previously classified under precision diagnostics in 2023.

在此之前，我們在提供收入突破時報告了製藥服務。為清楚起見，我們已將這一收入細分重新命名為生物製藥服務，以包括與製藥、生物技術、CRO 或研究組織的臨床測試相關的任何收入，其中約400 萬美元此前已在2023 年分類為精準診斷。

Regarding biopharma services, we exited 2022 with tremendous momentum, and 2023 took off at a very fast pace. However, unrelated to Fulgent, some of our biopharma clients have had issues and some of those projects have either pulled way back or been terminated altogether. Unfortunately, this did affect two of our larger clients.

在生物製藥服務方面，我們以巨大的勢頭結束了2022年，2023年以非常快的速度起飛。然而，與 Fulgent 無關的是，我們的一些生物製藥客戶遇到了問題，其中一些項目要么大幅推遲，要么完全終止。不幸的是，這確實影響了我們的兩個大客戶。

That said, we believe our bio pharma services capabilities are stronger today than ever, offering an impressive multiomic platform including technology for single--cell multiomics, rounding out our capabilities in whole genome, whole exome, RNA sequencing, tumor profiling, methylation sequencing, liquid biopsy, single cell sequencing, spatial biology, and pathology. The focus for 2024 is to forge new relationships and expand on existing ones.

也就是說，我們相信我們今天的生物製藥服務能力比以往任何時候都更強大，提供了令人印象深刻的多組學平台，包括單細胞多組學技術，完善了我們在全基因組、全外顯子組、RNA定序、腫瘤分析、甲基化定序、液體切片、單細胞定序、空間生物學和病理學。2024 年的重點是建立新的關係並擴展現有的關係。

We'd like to thank all of our employees who have dedicated so much energy into making Fulgent a great success. We have an amazing team. As one of our important clients recently said, quote, Fulgent seems to have a magic wand. And we don't, it would certainly be easier if we did, but we do have an absolutely amazing team. That said, 2023 has come to pass, and now all focus and energy shifts to 2024. It's a fast-paced, dynamic market, and we look forward to keeping our investors updated throughout the year.

我們要感謝所有為 Fulgent 取得巨大成功而付出巨大精力的員工。我們有一支出色的團隊。正如我們一位重要的客戶最近所說，富爾金特似乎擁有一根魔杖。我們不這樣做，如果我們這樣做肯定會更容易，但我們確實擁有一支絕對令人驚嘆的團隊。也就是說，2023 年已經過去，現在所有的焦點和精力都轉移到 2024 年了。這是一個快節奏、充滿活力的市場，我們期待全年為投資者提供最新資訊。

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

我現在將把電話轉給我們的財務長 Paul Kim。保羅？

Thanks Brandon. Revenue in the fourth quarter totaled $70 million compared to $68 million in the fourth quarter of 2022. $4 million came from COVID-19 testing in Q4, which was not part of our guidance. Revenue from our core business totaled $66 million, which slightly exceeded our guidance of $64 million and grew 21% year over year.

謝謝布蘭登。第四季的收入總計 7,000 萬美元，而 2022 年第四季的收入為 6,800 萬美元。其中 400 萬美元來自第四季度的 COVID-19 測試，這不屬於我們的指導範圍。我們的核心業務收入總計 6,600 萬美元，略高於我們 6,400 萬美元的指導，年增 21%。

Gross margin was 36%. The increase in gross margin year over year was primarily related to $4 million of COVID-19 revenue recognized on previously billed tests due to successful insurance collections in the current year and to charges which resulted from the wind down of COVID-19 business in Q4 of the prior year, including inventory reserves and accelerated equipment depreciation.

毛利率為36%。毛利率年增主要與由於本年度保險收款成功而在先前計費測試中確認的 400 萬美元的 COVID-19 收入以及由於 2019 年第四季度 COVID-19 業務結束而產生的費用有關。去年，包括庫存儲備和加速設備折舊。

Before turning to operating expenses, I would like to explain an impairment charge we took this quarter. We incurred a one-time, non-cash goodwill impairment charge of $120 million. This charge resulted from a sustained decline in our share price and associated market capitalization compared to the book value of our equity as of quarter end. I want to reiterate that the non-cash goodwill impairment charge was due to generally accepted accounting principles given the current market capitalization.

在討論營運費用之前，我想先解釋一下我們本季收取的減損費用。我們承擔了 1.2 億美元的一次性非現金商譽減損費用。這項費用是由於我們的股價和相關市值與截至季末的股權帳面價值相比持續下跌所致。我想重申，非現金商譽減損費用是根據當前市值的公認會計原則確定的。

It's important to note that the goodwill impairment charge does not affect the company's cash position, and we do not believe it will have any impact on our future operations, and we remain highly encouraged with the momentum we see ahead, as discussed earlier by Ming and Brandon.

值得注意的是，商譽減損費用不會影響公司的現金狀況，我們認為這不會對我們未來的營運產生任何影響，我們對我們看到的未來​​勢頭感到高度鼓舞，正如 Ming 和布蘭登.

The GAAP operating expenses were $176.4 million in the fourth quarter, an increase from $39.6 million in the third quarter of 2023. Non-GAAP operating expenses totaled $45.1 million, an increase from $29.4 million in the third quarter of 2023. Non-GAAP operating margin decreased 40 percentage points sequentially to a negative 24.8%, primarily due to lower COVID-19 testing revenue recognized, higher bad debt reserve, and one-time legal fees.

第四季 GAAP 營運費用為 1.764 億美元，較 2023 年第三季的 3,960 萬美元有所增加。非 GAAP 營運費用總計 4,510 萬美元，較 2023 年第三季的 2,940 萬美元增加。非 GAAP 營業利潤率環比下降 40 個百分點，至負 24.8%，這主要是由於確認的 COVID-19 測試收入減少、壞帳準備金增加以及一次​​性法律費用。

Adjusted EBITDA loss for the fourth quarter was $6.8 million compared to $15.1 million in the fourth quarter of 2022. On a non-GAAP basis and excluding equity-based compensation expense, goodwill impairment loss and intangible asset amortization, income for the quarter was $8.3 million or $0.28 per share on 30 million weighted average shares outstanding.

第四季調整後 EBITDA 損失為 680 萬美元，而 2022 年第四季為 1510 萬美元。以非公認會計準則計算，不包括股權補償費用、商譽減損損失和無形資產攤銷，本季營收為 830 萬美元，即 3,000 萬股加權平均每股收益 0.28 美元。

Turning to the balance sheet, we ended the fourth quarter with approximately $848 million in cash, cash equivalents, and marketable securities. We were active with our share repurchase program during the fourth quarter of 2023. We repurchased approximately 873,000 shares of our common stock at an aggregate cost of $22.9 million at an average price of $26.15 under the stock repurchase program announced in March of 2022. As of December 31, 2023, a total of approximately $150.7 million remained available for future repurchases of our common stock under the stock repurchase program.

轉向資產負債表，第四季末我們擁有約 8.48 億美元的現金、現金等價物和有價證券。我們在 2023 年第四季積極實施了股票回購計畫。根據 2022 年 3 月宣布的股票回購計劃，我們以 26.15 美元的平均價格回購了約 873,000 股普通股，總成本為 2,290 萬美元。截至 2023 年 12 月 31 日，根據股票回購計劃，仍有總計約 1.507 億美元可供未來回購普通股。

Now moving onto our outlook for 2024, starting with revenue, we may have some minimal revenue from COVID-19 testing in 2024, but we'll be guiding to core revenue which is total laboratory services revenue for the company without COVID-19 testing. We expect total core revenues to be approximately $280 million for 2024, representing a core growth of 7% year over year.

現在轉向我們對2024 年的展望，從收入開始，我們可能會在2024 年從COVID-19 測試中獲得一些最低收入，但我們將指導核心收入，即沒有進行COVID-19 測試的公司實驗室服務總收入。我們預計 2024 年核心總收入約為 2.8 億美元，核心年增 7%。

Breaking down this guidance between precision diagnostics, anatomic pathology, and biopharma services, the expected 2024 revenue is estimated as follows: $173 million from precision diagnostics, $96 million from anatomic pathology, and the remaining $11 million from biopharma services.

根據精確診斷、解剖病理學和生物製藥服務的指導，2024 年的預期收入估計如下：精確診斷收入為 1.73 億美元，解剖病理學收入為 9,600 萬美元，其餘 1,100 萬美元來自生物製藥服務。

On precision diagnostics, which includes all of our clinical NGS revenue: oncology, reproductive services, rare disease, neurogenetics, B2B relationships with labs, and our joint venture in China continues to be the highest growth area for the company in 2024. As Brandon discussed, we have seen strength in reproductive services from our Beacon product line. Given the timing of certain lab arrangements, there may be variability quarter to quarter.

在精準診斷方面，其中包括我們所有的臨床NGS 收入：腫瘤學、生殖服務、罕見疾病、神經遺傳學、與實驗室的B2B 關係以及我們在中國的合資企業仍然是該公司2024 年增長最高的領域。正如布蘭登所討論的，我們從 Beacon 產品線中看到了生殖服務的優勢。鑑於某些實驗室安排的時間安排，每個季度可能會有變化。

Both anatomic pathology and biopharma services continue to be major contributors to revenue in 2024; however, we are expecting a decline in both these revenue streams in 2024 as compared to 2023. For anatomic pathology, which includes the business we have integrated from Inform Diagnostics, pricing pressure and lower contract rates are impacting revenue. Biopharma services, which includes sequencing as a service, which we sell to pharmaceutical businesses and is dependent on these partners, has been impacted by projects that have terminated or have scaled back significantly. There is no revenue from our therapeutic development business anticipated for our 2024 guidance.

解剖病理學和生物製藥服務仍然是 2024 年收入的主要貢獻者；然而，我們預期 2024 年這兩個收入來源均較 2023 年下降。對於解剖病理學（包括我們從 Inform Diagnostics 整合的業務）而言，定價壓力和較低的合約費率正在影響收入。生物製藥服務（包括定序即服務）受到已終止或大幅縮減的項目的影響，我們將其出售給製藥公司並依賴這些合作夥伴。我們的 2024 年指導預計沒有來自治療開發業務的收入。

Turning to expected margins in 2024 excluding COVID-19 revenue and stock-based compensation, we expect non-GAAP gross margin to improve as we see the efficiencies of our integration efforts take effect, reaching the mid-30% range and positioning us to approach our target of 40% by the end of the year. We expect to see lower non-GAAP operating margins in the quarters ahead as we further invest resources to grow our business, with operating margin of approximately minus 20% for the year. We remain focused on managing our spend and continue to believe that our foundational technology and platform supports a long term, strong margin profile.

談到2024 年的預期利潤率（不包括COVID-19 收入和股票薪酬），我們預計非GAAP 毛利率將會改善，因為我們看到我們的整合工作的效率正在發揮作用，達到30% 的中間範圍，並使我們能夠接近我們的目標是到今年年底達到 40%。隨著我們進一步投入資源來發展業務，我們預計未來幾季的非公認會計原則營業利潤率將下降，全年營業利潤率約為-20%。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和平台支援長期、強勁的利潤狀況。

We expect associated cash burn for our therapeutics business of about $15 million to $17 million this year, which is contemplated in our EPS and our cash guidance provided today. For the full-year 2024, utilizing non-GAAP tax provision and average share count of 31 million, we expect our non-GAAP loss to be approximately $1.05 per share for our shareholders, excluding the stock-based compensation and amortization of intangible assets as well as any one-time charges.

我們預計今年治療業務的相關現金消耗約為 1500 萬至 1700 萬美元，這一點已在我們今天提供的每股收益和現金指導中考慮到。對於 2024 年全年，利用非 GAAP 稅收撥備和 3,100 萬股平均股數，我們預計股東的非 GAAP 虧損約為每股 1.05 美元，不包括基於股票的薪酬和無形資產攤銷以及任何一次性費用。

Moving onto cash, our cash position remains strong. We expect to have significant cash outlay of over $15 million this year as we build out and move into our brand new 96,500 square foot facility in the Dallas area. This facility will have state-of-the-art operations which include both pathology, neuropathology, and the NGS lab which broaden our diagnostics reach, as well as further streamline our clinical operations. Excluding any stock repurchases or any other expenditures outside ordinary course, we still anticipate ending 2024 with approximately $800 million of cash, cash equivalents and investments and marketable securities.

轉向現金，我們的現金狀況依然強勁。隨著我們在達拉斯地區建造並搬入全新的 96,500 平方英尺的工廠，我們預計今年將有超過 1500 萬美元的大量現金支出。該設施將擁有最先進的操作，包括病理學、神經病理學和 NGS 實驗室，從而擴大我們的診斷範圍，並進一步簡化我們的臨床操作。不包括任何股票回購或正常過程以外的任何其他支出，我們仍預計到 2024 年年底將擁有約 8 億美元的現金、現金等價物以及投資和有價證券。

Overall, we see strength in our core business, which has grown organically and through strategic acquisitions, and we see good momentum ahead.

總體而言，我們看到了我們的核心業務的實力，該業務透過策略性收購實現了有機成長，並且我們看到了未來的良好勢頭。

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

感謝您今天加入我們的電話會議。接線員，您現在可以打開它提問。

(Operator instructions) David Westenberg, Piper Sandler.

（操作員說明）David Westenberg、Piper Sandler。

Good job in Q4. So just a couple different things here. Let's just start with expectations for expanded carrier screening. Do you still anticipate that being a front half of the year ACOG recommendation? How fast would that impact your revenue, and just given the fact that you are, I think, mainly working in IVF, would that kind of thing catalyze maybe further investments in the sales force in order to look at that opportunity outside of --- into the broader markets?

第四季做得很好。這裡只是一些不同的事情。讓我們從對擴大攜帶者篩檢的期望開始。您是否仍預計這將成為今年上半年 ACOG 的推薦？這會對你的收入產生多快的影響，考慮到你主要從事體外受精工作，這種事情是否會促進對銷售隊伍的進一步投資，以便在…之外尋找機會進入更廣闊的市場？

It's hard to comment on the timing of ACOG policy changes, but certainly, we see it trending in that direction. We are participating in some of those discussions and advocating for better policy statement. Look, expanded carrier screening is standard of care today in medical practice, right. Doctors realize that, and they treat it as such.

很難對 ACOG 政策變化的時機發表評論，但可以肯定的是，我們看到它朝這個方向發展。我們正在參與其中一些討論並倡導更好的政策聲明。看，擴大攜帶者篩檢是當今醫療實踐中的標準護理，對吧。醫生意識到了這一點，並且他們也這樣對待它。

The guidelines are just sometimes lagging in that area, but when they align and when they catch up, good things happen. So any positive movement in those guidelines would be just additional tailwinds around reimbursement and coverage. I don't think those guidelines change adoption too much, but really would perhaps have some positive impact on reimbursements and things like that.

這些指導方針有時在該領域滯後，但當它們協調一致並迎頭趕上時，好事就會發生。因此，這些指導方針中的任何積極舉措都將成為報銷和保險範圍的額外推動力。我認為這些指導方針不會對採用產生太大影響，但確實可能會對報銷等產生一些積極影響。

In terms of investing in the sales team and addressing the broader market, you are correct -- a lot of our Beacon expanded carrier screening today is coming from the IVF clinics, and we've yet to penetrate the ob-gyn market. We believe there is some sort of ancillary in parallel products that are needed to bundle with Beacon before we really can penetrate that ob-gyn market, and we do have some development in those areas. It's certainly an area we want to expand into, so we think once we have that product portfolio ready to go to market, we could invest significantly in the sales team to address that broader market.

在投資銷售團隊和開拓更廣闊的市場方面，你是對的——我們今天的許多 Beacon 擴展攜帶者篩檢都來自 IVF 診所，而我們尚未滲透到婦產科市場。我們相信，在我們真正能夠滲透婦產科市場之前，需要有某種輔助的平行產品與 Beacon 捆綁在一起，而我們在這些領域確實取得了一些進展。這當然是我們想要擴展的領域，因此我們認為，一旦我們準備好產品組合進入市場，我們就可以對銷售團隊進行大量投資，以應對更廣泛的市場。

Got it. That was a great answer. Just maybe on COVID testing, if you just back out, you get $4 million of COVID testing in Q4. We are kind of in the heart of respiratory disease areas with only $4 million in revenue. Would it make strategic sense to just flat out exit that business, or maybe -- I mean, I think you guys already are de-emphasizing it. Just talk about strategies around that, thank you.

知道了。這是一個很好的答案。也許在新冠病毒檢測方面，如果你退出，你會在第四季獲得 400 萬美元的新冠病毒檢測費用。我們處於呼吸系統疾病領域的中心，收入只有 400 萬美元。直接退出該業務是否具有戰略意義，或者也許——我的意思是，我認為你們已經不再強調它了。就談談策略吧，謝謝。

Yeah, for all intents and purposes, we have exited the business. The amount of new testing we're doing is tiny. The revenue you're seeing is a result of our efforts to collect on tests that we've run in the past. So we have a phenomenal revenue cycle management team.

是的，出於所有意圖和目的，我們已經退出了這項業務。我們正在進行的新測試量很小。您看到的收入是我們根據過去運行的測試收集的努力的結果。因此，我們擁有一支出色的收入週期管理團隊。

They're tenacious. We fight for every dollar that we can, and what you're seeing is results of our team collecting on tests that we had previously run. So the amount of new testing, new revenue is practically zero. Like I said, it's pretty much completely de-emphasized at the company, but again we want to collect on every dollar that we're owed.

他們很頑強。我們竭盡全力爭取每一塊錢，您所看到的是我們團隊收集先前執行的測試的結果。因此，新測試的數量、新收入實際上為零。就像我說的，公司幾乎完全不重視這一點，但我們再次希望收回我們所欠的每一美元。

Makes a lot of sense. Just quickly for my last one, just want to talk about capital deployment. You had a lot of share repurchases in 2023. Is that still the game plan in 2024, or are you going to look at maybe some acquisitions, particularly with the -- I mean, I'm guessing in the market, we're going to see some adjacent market opportunity from companies that are exiting, going under, selling themselves, et cetera?

很有道理。很快我的最後一篇，只是想談談資本部署。2023 年你們進行了大量股票回購。這仍然是 2024 年的遊戲計劃嗎？或者您是否會考慮進行一些收購，特別是——我的意思是，我猜測在市場上，我們將看到來自以下公司的一些相鄰市場機會：退出、破產、出售自己等等？

I think we do see more opportunities available in the market, and the valuations will be getting more sense. But still, as we look for the business, which they are profoundly in terms of the long-term business plan. Also, we're looking for the companies which give us the -- that broaden our distribution channel or adding additional technology to make us even more efficient or more advanced in the testing area, so there is more opportunity we're looking for now and definitely in the current environment, I think we're in a good position to be a consolidator.

我認為我們確實看到市場上有更多機會，估值也會變得更有意義。但是，當我們尋找業務時，他們對長期業務計劃有著深刻的理解。此外，我們正在尋找能夠拓寬我們的分銷管道或添加額外技術的公司，使我們在測試領域更加高效或更先進，因此我們現在正在尋找更多的機會絕對在當前環境下，我認為我們處於成為整合者的有利位置。

Andrew Cooper, Raymond James.

安德魯庫珀，雷蒙德詹姆斯。

Maybe just first, kind of real simply, it sounds like there's some moving parts around moving, I think you said $4 million from PDX down to biopharma services. Can maybe just help level-set where each subsegment came in for 2023, and then also just in 4Q, what the growth looks like in each on an apples-to-apples basis, so that we can have the right expectation into 2024?

也許首先，簡單地說，聽起來好像有一些移動部件正在移動，我想你說過從 PDX 到生物製藥服務的 400 萬美元。也許可以幫助確定 2023 年每個細分市場的水平，然後在第四季度，每個細分市場的成長情況在同類基礎上是什麼樣子，以便我們對 2024 年有正確的預期？

Yeah, sure, okay. I'll first comment on the numbers, and then I'll turn it over to Brandon who can give color on where we see the decline and where we see the most amount of growth or the momentum.

是的，當然，好吧。我將首先對這些數字進行評論，然後我會將其交給布蘭登，他可以對我們看到的下降以及我們看到的增長或勢頭最多的地方給出顏色。

For the fourth quarter, we had revenues of $70 million. Approximately $4 million came from COVID, $35.5 million came from precision diagnostics, the biopharma services was $4.7 million, and anatomic pathology was $26.3 million. For the balance of 2023, we had $104.7 million of revenues from anatomic pathology, $25.4 million from biopharma services, and $132 million from precision diagnostics.

第四季度，我們的營收為 7000 萬美元。約 400 萬美元來自新冠肺炎，3,550 萬美元來自精準診斷，生物製藥服務 470 萬美元，解剖病理學 2,630 萬美元。到 2023 年，我們的解剖病理學收入為 1.047 億美元，生物製藥服務收入為 2,540 萬美元，精準診斷收入為 1.32 億美元。

We also had, as we previously discussed on COVID revenues, $27.1 million come from COVID, so the total revenues for 2023 were $289.2 million, of which revenue excluding COVID, or core was $262 million.

正如我們先前討論的新冠疫情收入一樣，2,710 萬美元來自新冠疫情，因此 2023 年的總收入為 2.892 億美元，其中不包括新冠疫情的收入或核心收入為 2.62 億美元。

For the $280 million guide that we're giving for 2024, that does not include any COVID, the projected are as follows in the three revenue categories: for anatomic pathology, it's $96.3 million; bio pharma services is $10.7 million, and precision diagnostics is $173.3 million, so as you can see when you compare these categories versus 2023, we had a slight decline projected that we're anticipating for 2024 in anatomic pathology. We had a significant decline projected for our biopharma services, and we see a lot of momentum behind precision diagnostics.

對於我們為 2024 年提供的 2.8 億美元指南（不包括任何新冠肺炎），三個收入類別的預期收入如下：解剖病理學為 9,630 萬美元；生物製藥服務為 1070 萬美元，精準診斷為 1.733 億美元，因此當您將這些類別與 2023 年進行比較時可以看到，我們預計 2024 年解剖病理學領域的收入將略有下降。我們預計生物製藥服務將大幅下降，但我們看到精準診斷背後的巨大動力。

And I'll turn it over to Brandon who can give some color into the variability for each of those three areas.

我將把它交給布蘭登，他可以為這三個領域中的每一個領域的可變性提供一些顏色。

Yeah, certainly. We talked a little bit about it in the script, but on the AP side, the anatomic pathology side, it has really been a mix of issues. We've had some physician clients enter retirement, we've had practices be acquired, we've had practices merge with other groups, we've had clients joining super groups, and those super groups usually have their own laboratory, for example. We did mention some limited pressure on reimbursement -- I mean, there is a little bit there, but it has really been a mix of things on the AP side. However, it's really nothing out of the ordinary for the industry.

是的，當然。我們在劇本中對此進行了一些討論，但在美聯社方面，解剖病理學方面，這確實是一個混合問題。例如，我們有一些醫生客戶進入退休狀態，我們有診所被收購，我們有診所與其他團體合併，我們有客戶加入超級團體，而這些超級團體通常有自己的實驗室。我們確實提到了一些有限的報銷壓力——我的意思是，確實有一點壓力，但實際上是美聯社方面的各種因素的混合。然而，對於這個行業來說，這確實沒什麼不尋常的。

That said, we need to outpace that, so it's our goal to build a best-in-class sales team and find new opportunities to return AP to growth. I think if you're looking at that division, we have the turnaround time, the quality, subspecialty trained pathologists, the connectivity. We have what it takes to win, and we intend to do that. But as mentioned, we continue to invest in digital pathology and AI and our operations. We want to become more efficient in that area as well, so we do intend to address some of those losses by finding and forging new client relationships.

也就是說，我們需要超越這一點，因此我們的目標是建立一支一流的銷售團隊並尋找新的機會來使 AP 恢復成長。我想如果你關注那個部門，我們有周轉時間、品質、受過專科訓練的病理學家和連結性。我們擁有獲勝所需的一切，並且我們打算做到這一點。但如上所述，我們繼續投資於數位病理學、人工智慧以及我們的營運。我們也希望在該領域變得更加高效，因此我們確實打算透過尋找和建立新的客戶關係來解決其中一些損失。

On the pharma side, it's a little bit more of a centralized issue affecting a couple clients. I think on the pharma headwinds, it really boils down to a couple, or maybe just a very few significant-sized clients that wound down their projects. This is mostly related to some of their financial stress and not related to any service issues with Fulgent. We mentioned that our biopharma services have really expanded, and now it's our goal to drive deeper relationships with our existing clients but also continue to go find new clients.

在製藥方面，這更像是影響幾個客戶的集中問題。我認為，就製藥業的逆風而言，這實際上可以歸結為幾個，或者可能只是極少數大型客戶結束了他們的專案。這主要與他們的一些財務壓力有關，與 Fulgent 的任何服務問題無關。我們提到我們的生物製藥服務確實得到了擴展，現在我們的目標是與現有客戶建立更深入的關係，同時繼續尋找新客戶。

We do believe there is demand for the types of products and services we've built, but I think the takeaway from that, even with the divisional headwinds in AP and pharma, we're still forecasting growth in 2024. It's around 30% growth in precision diagnostics, and this is the area where we can best leverage our technology platform.

我們確實相信我們所建構的產品和服務類型有需求，但我認為，即使面臨美聯社和製藥部門的逆風，我們仍然預測 2024 年會出現成長。精準診斷領域成長了 30% 左右，這是我們可以最好地利用我們的技術平台的領域。

Okay. Super, super helpful. Appreciate that. Maybe just dialing in a little bit on AP. If we go back to the deal announcement in the first couple quarters post, I think a lot of the logic was this was a strategic move, I think in large part on being able to roll some of the contracts across to the broader Fulgent business. With you just mentioning, at least, part of the headwind being a little bit lower contract rates, anything changed there substantially or is it more, like you just said Brandon, kind of normal course of business in the industry, a little bit of pressure but nothing that changes the way you view that broader opportunity?

好的。超級，超級有幫助。感謝。也許只是在美聯社上稍微撥一下。如果我們回到前幾季的交易公告，我認為很多邏輯是這是一項策略舉措，我認為很大程度上是為了能夠將一些合約延伸到更廣泛的 Fulgent 業務。你剛才提到，至少，部分阻力是合約利率稍微低一點，任何事情都發生了實質性的變化，或者是更多，就像你剛才說的布蘭登，行業的正常業務過程，有點壓力但沒有什麼可以改變您看待更廣泛機會的方式嗎？

You are correct, normal course of business. These are normal constraints on contract pricing. It's what we've seen forever. Nothing at a macro level that would affect our ability to leverage these contracts across the organization. Actually, that's going quite well.

你是對的，正常的業務流程。這些都是合約定價的正常限制。這是我們永遠看到的。從宏觀層面來看，沒有任何事情會影響我們在整個組織內利用這些合約的能力。事實上，一切進展順利。

I think the thing to really note, because we're talking about these categories, is the power and momentum that we're seeing from the precision diagnostics, meaning that if you kind of take a step back, and these are all organic numbers, in 2022 for precision diagnostics, we did $97.3 million. For 2023, that $97.3 million is $131 million, and for the projected in 2024 we're anticipating precision diagnostics to be in excess of $173 million. That's over a 31% organic growth in that part of the business.

我認為真正需要注意的是，因為我們正在談論這些類別，所以我們從精確診斷中看到了力量和動力，這意味著如果你退一步，這些都是有機數字， 2022 年，我們在精準診斷方面投入了9730 萬美元。到 2023 年，這 9,730 萬美元相當於 1.31 億美元，而到 2024 年，我們預計精準診斷將超過 1.73 億美元。這部分業務的有機成長超過 31%。

How the company was constructed, where we were founded, which is full sequencing and NGS, that is having tremendous momentum in 2023 and we anticipate that momentum to continue in 2024.

公司是如何建構的，我們是在哪裡成立的，即全定序和 NGS，這將在 2023 年產生巨大的勢頭，我們預計這種勢頭將在 2024 年繼續下去。

Yes, adding to both Brandon and Paul's comments, I think in terms of when we purchased this asset, we talked about the insurance coverage because that insurance coverage fueled our growth of precision diagnostics, such as the carrier screening business. But in terms in general, AP, it is a pretty -- in general it's not that impressive in terms of margins and it strongly depends on the labor. We have been starting implementing our cost cutting process. You will see the improvement of operating margins from the AP business.

是的，補充布蘭登和保羅的評論，我認為在我們購買這項資產時，我們討論了保險範圍，因為保險範圍推動了我們精準診斷的增長，例如運營商篩選業務。但總的來說，美聯社的利潤率並不那麼令人印象深刻，而且很大程度取決於勞動力。我們已經開始實施成本削減流程。您將看到 AP 業務營業利潤率的提高。

However, the AP business is one of the areas that has lack of technology investment. We will heavily invest in the infrastructure and technology. You will see the turnaround in the AP business. Maybe that's one of the areas really drive the future of our digital AI innovation, so it has taken us about two years, into three years try to turn that business around, but we also see a lot of potential for us to make the technology innovation in that area.

然而AP業務是技術投入不足的領域之一。我們將大力投資基礎設施和技術。您將看到 AP 業務的改善。也許這是真正推動我們數位人工智慧創新未來的領域之一，所以我們花了大約兩年、三年的時間試圖扭轉這項業務，但我們也看到了技術創新在那個地區的巨大潛力。

Okay, super helpful. Maybe just one last quick one, just an update on the beginning of the more national rollout for Fulgent oncology. Would love a little bit of what happened in the fourth quarter and what you've learned, if anything new, and what the trajectory looks like from your perspective there.

好的，超級有幫助。也許只是最後一個快速的消息，只是關於 Fulgent 腫瘤學在全國範圍內推廣的開始的最新消息。我會喜歡一些第四季發生的事情和你學到的東西，如果有什麼新的東西，以及從你的角度來看軌跡是什麼樣的。

Yes, certainly. Thanks for the question. Recently, we've seen some tremendous momentum, recently, as in sort of January and February, so we'll be maybe talking more about this in detail on the next call. But we have had some significant wins in the Fulgent oncology division. As we've mentioned previously, we've secured very robust reimbursement for those assays, both north of $2,000, $2,200 for our solid tumor profile and our hematological malignancy profile, so yes, great momentum.

是的，當然了。謝謝你的提問。最近，我們看到了一些巨大的勢頭，就像一月和二月一樣，所以我們可能會在下次電話會議上詳細討論這一點。但我們在 Fulgent 腫瘤學部門取得了一些重大勝利。正如我們之前提到的，我們已經為這些檢測獲得了非常強勁的報銷，實體瘤概況和血液惡性腫瘤概況均超過 2,000 美元，2,200 美元，所以是的，勢頭強勁。

We've expanded the sales team some, it's still pretty small but we're walking before we run approach to things. But we think the opportunity is there, the clients seem to be very happy with our turnaround time, our quality, our report layout, our Q&S rate which is fantastic, just very, very good in terms of our ability to process small amounts of tumor tissue. So yeah, the business has momentum, and I think next quarter, we'll be giving more color.

我們擴大了銷售團隊，規模仍然很小，但我們在採取行動之前先行一步。But we think the opportunity is there, the clients seem to be very happy with our turnaround time, our quality, our report layout, our Q&S rate which is fantastic, just very, very good in terms of our ability to process small amounts of tumor組織.所以，是的，業務有動力，我認為下個季度，我們將提供更多色彩。

Great, I'll stop there. Thanks for the time.

太好了，我就到此為止。謝謝你的時間。

[Liu Li] UBS.

[劉莉]瑞銀.

Great, thank you. Thank you for taking my question. I guess I wanted to touch a little bit on carrier screening. I think in the prepared remarks, you mentioned market shake-up in whole stage. Just wondering, can you could give any color in terms of why do you see share gain opportunity, and is that baked into the guide?

太好了謝謝。感謝您回答我的問題。我想我想談談攜帶者篩檢。我想你在準備好的發言中提到了整個階段的市場震盪。只是想知道，您能否就為什麼您看到分享收益機會給出任何顏色，並且這是否已納入指南中？

Thank you for the question. We certainly benefited from the market shake-up in 2023 with one of the larger players exiting the space entirely. We gained significant market share during that event. A similar but different situation is sort of happening in real time, and we are gaining clients from that shake-up as well. I think, as I mentioned, clients are looking for stability.

感謝你的提問。我們無疑從 2023 年的市場動盪中受益，其中一家較大的參與者完全退出了該領域。在那次活動中，我們獲得了顯著的市場份額。類似但不同的情況正在即時發生，我們也從這種變化中贏得了客戶。我認為，正如我所提到的，客戶正在尋求穩定性。

Our Beacon product is performing incredibly well, it has the right gene content, the right turnaround time. Our ability to custom design these panels, do merged couple reporting for calculating residual risk, we have what it takes to win, so as these clients whose lives have been disrupted by these events look for a new lab partner, I think we rank pretty high with them. In 2024, living in real time, we are seeing the sales pipeline and funnel fill up with new opportunities around carrier screening.

我們的 Beacon 產品表現得非常好，它具有正確的基因內容和正確的周轉時間。我們有能力定制設計這些面板，進行合併夫婦報告以計算剩餘風險，我們有能力獲勝，因此，當這些生活被這些事件擾亂的客戶尋找新的實驗室合作夥伴時，我認為我們排名相當高跟他們。到 2024 年，我們將即時看到銷售管道和漏斗充滿了圍繞運營商篩選的新機會。

Got it, appreciate it. I think second question is coming back to the guidance. Do you see any potential upside or downside to the guide?

明白了，欣賞一下。我認為第二個問題又回到了指導方針。您認為該指南有任何潛在的優點或缺點嗎？

We always see upside to the guide. If you remember, last year we raised our guidance twice. We first started off at $240 million of revenue, we raised it, and then recently it was at $260 million, and I'm just talking about the core, and it came in at $262 million. We also anticipated that the cash burn for 2023 would be somewhat more meaningful than what we anticipated, but the ending cash, and that's including buying back about $25 million worth of stock, was a lot better than I think the general consensus that was out there, so we reserve the right to raise our guidance in 2024 and we also reserve the right to have our cash balance be better than the approximate $800 million.

我們總是看到指南的優點。如果您還記得的話，去年我們兩次提高了指導值。我們一開始的收入是 2.4 億美元，我們籌集了它，然後最近它達到了 2.6 億美元，我只是談論核心，它的收入達到了 2.62 億美元。我們也預計 2023 年的現金消耗將比我們預期的更有意義，但最終現金（包括回購價值約 2500 萬美元的股票）比我認為的普遍共識要好得多，因此我們保留提高2024 年指導的權利，也保留讓現金餘額高於約8 億美元的權利。

Okay, I think I missed some of the part, I think my line is not that great. But we can definitely go offline on this. I guess a final question, any update on the LDT? Have you heard anything on when we should see the result, anything -- any color would be great.

好吧，我想我錯過了一些部分，我想我的台詞不是那麼好。但我們絕對可以在這方面下線。我想最後一個問題是，LDT 有更新嗎？你有沒有聽說過什麼時候我們應該看到結果，任何顏色都很棒。

Are you asking about the FDA's potential oversight of laboratory developed tests?

您是否想了解 FDA 對實驗室開發的測試的潛在監督？

Yes.

是的。

Yeah, we haven't seen too much, probably we've seen what you've seen. Some of the write-ups that have been published, the FDA warming up to the idea that they do have jurisdictional oversight of laboratory developed tests. Look, I mean, they're going to do what they're going to do. There has been a lot of pushback from industry leaders that this is not the right approach in that it could limit patients' access to really important tests, but ultimately, they'll do what they're going to do.

是的，我們還沒有看到太多，也許我們已經看到了你所看到的。在已發表的一些文章中，FDA 逐漸意識到他們確實對實驗室開發的測試擁有司法管轄權。聽著，我的意思是，他們會做他們要做的事。行業領導者強烈反對，認為這不是正確的方法，因為它可能會限制患者接受真正重要的測試，但最終，他們會做他們要做的事情。

And we will react accordingly, right? If we need to put high-risk genetic testing through their process to get it approved, we'll do that. We have the quality systems in place. We have the infrastructure, and that could be a benefit to us actually. Maybe some of the other labs don't have the ability to get some of these things approved.

我們會做出相應的反應，對嗎？如果我們需要透過他們的流程進行高風險基因檢測以獲得批准，我們會這樣做。我們擁有適當的品質系統。我們擁有基礎設施，這對我們來說實際上是有好處的。也許其他一些實驗室沒有能力讓其中一些事情獲得批准。

Whichever way they go, if they continue to exercise jurisdictional discretion, we will continue to operate as LDTs. If they do give us a list of perhaps high risk tests they want us to focus on putting through a 510(k) process, then we'll do that. Either way, I think we have what it takes to still perform in that new environment.

無論他們走哪條路，如果他們繼續行使司法自由裁量權，我們將繼續作為 LDT 運作。如果他們確實給了我們一份可能是高風險測驗的清單，他們希望我們專注於完成 510(k) 流程，那麼我們就會這樣做。不管怎樣，我認為我們有能力在新環境中繼續表現。

Got it, appreciate it.

明白了，欣賞一下。

Thank you. That concludes our question-and-answer session, and this concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.

謝謝。我們的問答環節到此結束，我們今天的電話會議到此結束。我們感謝您的興趣和參與。現在您可以斷開線路。