Charles River Laboratories International Inc (CRL) 2025 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Charles River Laboratories first-quarter 2025 earnings conference call. This call is being recorded. (Operator Instructions)

女士們，先生們，感謝你們的支持，歡迎參加 Charles River Laboratories 2025 年第一季財報電話會議。此通話正在錄音。（操作員指示）

I would now like to turn the conference over to our host, Todd Spencer, Vice President of Investor Relations. You may go ahead.

現在，我想將會議交給我們的主持人、投資者關係副總裁 Todd Spencer。你可以繼續。

Good morning, and welcome to Charles River Laboratories' first-quarter 2025 earnings conference call and webcast. This morning, I am joined by Jim Foster, Chair, President and Chief Executive Officer; and Flavia Pease, Executive Vice President and Chief Financial Officer. They will comment on our results for the first quarter of 2025. Following the presentation, they will respond to questions.

早安，歡迎參加 Charles River Laboratories 2025 年第一季財報電話會議及網路廣播。今天上午，我與董事長、總裁兼執行長 Jim Foster 一起出席；以及執行副總裁兼財務長 Flavia Pease。他們將對我們 2025 年第一季的業績發表評論。演講結束後，他們將回答問題。

There is a slide presentation associated with today's remarks, which will be posted on the Investor Relations section of our website at ir.criver.com. A replay of this call will be available beginning approximately two hours after the call today and can also be accessed on our Investor Relations website. The replay will be available through the next quarter's conference call.

今天的演講附有幻燈片演示，將發佈在我們的網站 ir.criver.com 的投資者關係部分。本次電話會議的重播將於今天電話會議結束後約兩小時開始提供，也可以在我們的投資者關係網站上訪問。重播將透過下一季的電話會議提供。

I'd like to remind you of our safe harbor. All remarks that we make about future expectations, plans and prospects for the company constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated. During this call, we will primarily discuss non-GAAP financial measures, which we believe help investors gain meaningful understanding of our core operating results and guidance. The non-GAAP financial measures are not meant to be considered superior to or a substitute for results from operations prepared in accordance with GAAP.

我想提醒你我們的安全港。我們對公司未來預期、計畫和前景所做的所有評論均構成 1995 年《私人證券訴訟改革法案》下的前瞻性陳述。實際結果可能與所示結果有重大差異。在本次電話會議中，我們將主要討論非公認會計準則財務指標，我們相信這有助於投資人深入了解我們的核心經營績效和指引。非公認會計準則財務指標並不意味著優於或取代依照公認會計準則編制的經營績效。

In accordance with Regulation G, you can find the comparable GAAP measures and reconciliations on the Investor Relations section of our website.

根據 G 規則，您可以在我們網站的投資者關係部分找到可比較的 GAAP 指標和對帳。

I will now turn the call over to Jim Foster.

現在我將電話轉給吉姆·福斯特。

Thank you, Todd, and thank you all for joining us today. Before discussing our first quarter results, I'd like to take a few minutes to directly address an important regulatory development, the FDA's announcement last month outlining their goal to accelerate the validation and adoption of New Approach Methods, or NAMs, to reduce the animal testing in preclinical safety assessment. I will also provide an update on our own ongoing strategy around alternative methods which we will continue to incorporate into our business in the future.

謝謝你，托德，也謝謝大家今天加入我們。在討論我們的第一季業績之前，我想花幾分鐘時間直接談一談一項重要的監管發展，即 FDA 上個月宣布的目標，即加速驗證和採用新方法（NAM），以減少臨床前安全評估中的動物試驗。我還將提供有關替代方法的持續策略的最新信息，我們將在未來繼續將這些方法納入我們的業務中。

Charles River supports the FDA's vision to leverage scientific advancement to safely advance innovative technologies, including alternatives to animal use. As the leader in preclinical drug development, our long-standing mission is aligned with this vision as we continue to drive greater efficiency in the drug development process and reduce costs, enhance scientific innovation and promote the responsible use of animals in biomedical research. Our perspective on leading through a NAMs-enabled future is as follows: First, the evolution of NAMs is not new and demonstrates that scientific advancements are continuing to move forward.

Charles River 支持 FDA 的願景，即利用科學進步來安全地推進創新技術，包括動物使用的替代品。作為臨床前藥物開發的領導者，我們的長期使命與這一願景一致，我們將繼續提高藥物開發過程的效率並降低成本，加強科學創新並促進在生物醫學研究中負責任地使用動物。我們對引領 NAM 未來的觀點如下：首先，NAM 的演變並不是什麼新鮮事，它表明科學進步正在不斷向前發展。

For more than 50 years, efforts to reduce animal use by Charles River and industry have led to a gradual decline in research model volumes. These efforts include better translational models and technologies, such as genetically modified and immunodeficient models that can mimic human disease. For example, our volumes of outbred rodents often used in safety assessment have been roughly halved over the past 10 years due to the use of more complex and predictive models, technologies and services, including imaging and in vitro applications, all while our revenue has increased significantly.

50 多年來，查爾斯河公司和工業界一直致力於減少動物的使用，導致研究模型的數量逐漸減少。這些努力包括更好的轉化模型和技術，例如可以模擬人類疾病的轉基因和免疫缺陷模型。例如，由於使用了更複雜和預測性的模型、技術和服務（包括影像和體外應用），我們用於安全評估的雜交囓齒動物的數量在過去 10 年裡大約減少了一半，而與此同時我們的收入卻大幅增加。

NAMs are part of this broader trend. For many years, CROs like Charles River, the biopharmaceutical industry and the FDA and international regulatory agencies have been evaluating strategies to use NAMs as tools to complement traditional methods, and in some cases, to potentially eliminate certain animal tests. Through this evolution, the promise of NAMs will be balanced with the importance of patient safety and science. NAMs are beginning to offer exciting opportunities for the future, but they are not capable of fully replacing animal studies in biomedical research and safety testing. Each NAMs tool will require rigorous validation to prove it can consistently replicate the complexity of living systems and ensure patient safety.

NAM 是這一更廣泛趨勢的一部分。多年來，Charles River 等 CRO、生物製藥行業以及 FDA 和國際監管機構一直在評估使用 NAM 作為補充傳統方法的工具的策略，在某些情況下，甚至可以消除某些動物試驗。透過這種演變，NAM 的前景將與患者安全和科學的重要性保持平衡。NAM 開始為未來提供令人興奮的機會，但它們還不能完全取代生物醫學研究和安全測試中的動物研究。每個 NAM 工具都需要經過嚴格的驗證，以證明它能夠持續複製生命系統的複雜性並確保病患安全。

There are applications where NAMs may play a valuable role more quickly, such as monoclonal antibodies, but significant scientific advancements and validation will be required before alternative methods can become more widely adopted. This technology to mimic a complex living organism doesn't exist today. Therefore, we believe there will be incremental progress over time, and the broader adoption of NAMs will be a longer-term journey, one that is much longer than three to five years.

在某些應用中，NAM 可能會更快發揮重要作用，例如單株抗體，但在替代方法得到更廣泛採用之前，還需要重大的科學進步和驗證。這種模擬複雜生物體的技術目前還不存在。因此，我們相信隨著時間的推移，將會取得逐步的進展，而 NAM 的更廣泛採用將是一個長期的過程，遠遠超過三到五年。

As the science continues to advance, we believe the biopharmaceutical industry and regulators will maintain a keen focus on ensuring patient safety without compromise. As NAMs evolve, we intend to advance hybrid study designs by complementing traditional in vivo and in vitro methods with NAMs and other nonanimal technologies. Given the current state of science and technology, NAMs are still primarily used in drug discovery because of the narrower focus on drug design and optimization, whereas in safety assessment, a more comprehensive approach is required to determine the full systemic or multi-organ impacts of a drug.

隨著科學的不斷進步，我們相信生物製藥行業和監管機構將繼續密切關注確保患者安全，絕不妥協。隨著 NAM 的發展，我們打算透過 NAM 和其他非動物技術補充傳統的體內和體外方法來推進混合研究設計。鑑於目前的科學技術水平，NAM 仍然主要用於藥物發現，因為它主要關注藥物設計和優化，而在安全性評估中，需要更全面的方法來確定藥物對全身或多器官的影響。

Chronic or longer-term assessments of a drug's impact are also critical, as well as off-target or unintended effects, which NAMs can't fully replicate at this time. However, similar to applications in drug discovery, we believe a hybrid model submitting NAMs data in parallel with animal data will prove to be the best approach to ensure patient safety for regulated safety testing over the long term.

對藥物影響的慢性或長期評估也至關重要，以及脫靶或非預期的影響，而 NAM 目前無法完全複製這些影響。然而，與藥物發現中的應用類似，我們相信，同時提交 NAM 數據和動物數據的混合模型將被證明是確保長期受監管的安全測試患者安全的最佳方法。

Ultimately, we believe the future isn't binary. The use of animals will remain beneficial to support certain complex safety and efficacy endpoints even as hybrid study designs that incorporate both NAMs and animal data gain traction. As a result, we view this as an opportunity for Charles River, and we will continue to expand our non-animal platforms. Our leadership in preclinical drug development is not confined to animal models. It is rooted in science and innovation, regulatory insights and translational expertise.

最終，我們相信未來並不是二元的。即使結合 NAM 和動物數據的混合研究設計越來越受到關注，使用動物仍然有利於支持某些複雜的安全性和有效性終點。因此，我們認為這是 Charles River 的一個機遇，我們將繼續擴展我們的非動物平台。我們在臨床前藥物開發方面的領導地位不僅限於動物模型。它植根於科學和創新、監管見解和轉化專業知識。

That expertise is equally applicable to NAMs for which we have a growing portfolio of capabilities. We will continue to invest heavily in these capabilities through organic innovation, technology partnerships and targeted M&A.

這些專業知識同樣適用於我們擁有日益豐富能力的 NAM。我們將繼續透過有機創新、技術合作和有針對性的併購對這些能力進行大量投資。

As regulatory expectations continue to evolve, our clients are seeking trusted partners to help them navigate the transition. Charles River is the logical partner to assist biopharmaceutical clients to validate and advance the use of NAMs because of the scientific data that we possess and our regulatory expertise. Drug development is ultimately about scientific data, and we have generated significant client databases of toxicology information over our 25 years in the industry that can help create more predictive and efficient safety methodologies that do not compromise patient safety.

隨著監管預期的不斷發展，我們的客戶正在尋求值得信賴的合作夥伴來幫助他們完成轉型。由於我們擁有的科學數據和監管專業知識，Charles River 是協助生物製藥客戶驗證和推廣 NAM 使用的合理合作夥伴。藥物開發最終依賴科學數據，我們在該行業 25 年的經驗中，已經建立了大量的毒理學資訊客戶資料庫，這有助於創建更具預測性和效率的安全方法，同時不會危及患者的安全。

Charles River has a well-established commitment to and track record for the replacement, reduction and refinement or the 3 Rs of ethical animal use for biomedical research and has supported the FDA's efforts as well as the NIH's to advance the validation and adoption of NAMs over many years. We have recognized this trajectory of science and technology for many years. And in April 2024, we formalized our own Alternative Methods Advancement Project, or AMAP initiative, dedicated to advancing the development of alternatives to reducing animal testing.

Charles River 一直致力於替代、減少和改進生物醫學研究中動物使用的道德原則，並擁有良好的業績記錄，多年來一直支持 FDA 和 NIH 推動 NAM 驗證和採用的努力。我們多年來已經認識到了這條科技軌跡。2024 年 4 月，我們正式啟動了自己的替代方法推進計畫（AMAP 計畫），致力於推動減少動物試驗的替代方案的發展。

We have made strategic investments over the past decade in areas that are central to the NAMs ecosystem with growing capabilities that include steroid, organoid and organ-on-a-chip platforms, human tissue models, in silico modeling, advanced in vitro toxicology and predictive immunotoxicology assays.

過去十年來，我們對 NAM 生態系統的核心領域進行了戰略投資，其能力不斷增強，包括類固醇、類器官和器官晶片平台、人體組織模型、電腦模擬、先進的體外毒理學和預測免疫毒理學檢測。

We have also invested in projects using computational modeling to increase efficiency and reduce animal usage, as exemplified by our Logica platform pairing AI with traditional methods. We acquired the Retrogenix's cell microarray technology for off-target screening and toxicity. And we also launched a pilot program to replace animals with virtual control groups for safety assessment studies.

我們還投資了使用運算模型來提高效率和減少動物使用的項目，例如將人工智慧與傳統方法結合的 Logica 平台。我們獲得了 Retrogenix 的細胞微陣列技術，用於脫靶篩選和毒性研究。我們還啟動了一項試點項目，以虛擬對照組取代動物進行安全評估研究。

Slide 9 in our earnings presentation showcases the current state of NAMs and our capabilities across the various NAMs platforms. In total, we generate approximately $200 million of annual DSA revenue from NAMs, much of which is in the discovery phase. We believe our NAMs capabilities and associated revenue will grow meaningfully over time as gradual technological progress continues.

我們的收益簡報中的第 9 張投影片展示了 NAM 的當前狀態以及我們在各個 NAM 平台上的能力。總體而言，我們每年從 NAM 中獲得約 2 億美元的 DSA 收入，其中大部分處於發現階段。我們相信，隨著技術的不斷進步，我們的 NAM 能力和相關收入將隨著時間的推移而顯著增長。

I'd like to take a moment to address the potential financial impact to Charles River from the FDA announcement. The FDA has focused on monoclonal antibodies for its pilot program, specifically to reduce the duration of chronic NHP studies. We believe the FDA chose this path because on a case-by-case basis, it has already been waiving certain chronic post-IND NHP studies for monoclonal antibodies for many years using a weighted evidence model because the scientific data has demonstrated that in many cases, there is limited benefit to conducting additional chronic NHP studies. This is likely because monoclonal antibodies generally show less toxicity than small molecule drugs and have a lower risk for unexpected reactions. In addition, certain monoclonal antibodies have no relevant research models to use in safety testing.

我想花點時間來談談 FDA 公告對 Charles River 可能造成的財務影響。FDA 的試點計畫重點關注單株抗體，特別是為了縮短慢性 NHP 研究的持續時間。我們認為 FDA 之所以選擇這條道路，是因為多年來，它一直在根據具體情況，使用加權證據模型，豁免某些單株抗體的 IND 後慢性 NHP 研究，因為科學數據表明，在許多情況下，進行額外的慢性 NHP 研究的益處有限。這可能是因為單株抗體通常比小分子藥物毒性較小，發生意外反應的風險較低。此外，某些單株抗體沒有相關的研究模型可用於安全性測試。

Chronic NHP studies longer than three months in monoclonal antibodies represented $50 million of our annual revenue. We do not expect any immediate impact on our business.

對單株抗體進行超過三個月的慢性 NHP 研究為我們帶來了 5000 萬美元的年收入。我們預計這不會對我們的業務造成任何直接影響。

On slide 11, we have provided an updated view of our Safety Assessment revenue by drug modality for reference. As you can see, the bulk of our revenue is from small molecule and newer advanced biological drugs, including cell and gene therapies. The FDA has not yet focused on these other drug modalities because understanding the safety profile can be more complex and less predictable than monoclonal antibodies. And in the case of newer biologic drugs, there is also less data available to support non-animal-based risk assessments. Therefore, extensive validation work and scientific advancements are needed to safely complement the current in vivo protocols with new alternative methods.

在第 11 張投影片上，我們提供了按藥物方式劃分的安全評估收入的最新視圖，以供參考。如您所見，我們的大部分收入來自小分子和較新的先進生物藥物，包括細胞和基因療法。FDA 尚未關注這些其他藥物形式，因為了解其安全性比單株抗體更複雜且更難預測。對於較新的生物藥物而言，支持非動物風險評估的數據也較少。因此，需要進行大量的驗證工作和科學進步，以便用新的替代方法安全地補充目前的體內方案。

This will take a significant amount of time and require resources and collaboration between the FDA, NIH and other agencies, as well as the biopharmaceutical industry.

這將花費大量時間，並需要 FDA、NIH 和其他機構以及生物製藥行業的資源和合作。

We applaud the FDA's ongoing efforts to reduce animal use. And while the transition to NAMs is evolutionary, rather than revolutionary, it's an important one for biomedical research and one that Charles River is prepared to lead. In the coming years, we look forward to continuing to work with regulatory agencies, the biopharmaceutical industry and other stakeholders to help develop, validate and implement an efficient process for our clients' regulatory submissions that supports the use of nonanimal technologies and new alternative methods. As we always have, Charles River will remain committed to following the best and latest science to ensure patient safety.

我們讚揚 FDA 為減少動物使用所做的持續努力。儘管向 NAM 的轉變是漸進的，而不是革命性的，但它對生物醫學研究來說卻是一個重要的轉變，也是 Charles River 準備好引領的轉變。在未來的幾年裡，我們期待繼續與監管機構、生物製藥行業和其他利益相關者合作，幫助開發、驗證和實施一個高效的流程，為我們的客戶提供監管提交，支持使用非動物技術和新的替代方法。正如我們一直以來所做的那樣，Charles River 將始終致力於遵循最佳和最新的科學來確保患者的安全。

Now I'd like to provide an update on the market trends. Despite considerable uncertainty in the broader market environment, our first quarter financial results demonstrated continued signs of stabilization with a better-than-expected DSA performance, leading us to modestly increase our financial guidance for the year. We were pleased to see the DSA net book-to-bill return to just above 1 times for the first time in over two years due to improved quarterly bookings.

現在我想介紹一下市場趨勢的最新情況。儘管更廣泛的市場環境存在相當大的不確定性，但我們的第一季財務業績顯示出持續的穩定跡象，DSA 表現好於預期，這促使我們適度提高了今年的財務指導。我們很高興看到，由於季度訂單量的增加，DSA 淨訂單出貨比兩年多來首次回升至 1 倍以上。

While this is a positive development for the DSA segment, we remain cautious in light of recent market dynamics, including government funding cuts, particularly at the NIH and FDA, the slower start for biotech funding and tariffs. These developments have understandably contributed to a broader sense of uncertainty in the marketplace.

雖然這對 DSA 領域來說是一個積極的發展，但鑑於最近的市場動態，我們仍然保持謹慎，包括政府資金削減（特別是 NIH 和 FDA 的資金削減）、生物技術資金起步較慢以及關稅。可以理解的是，這些發展加劇了市場更廣泛的不確定性。

While we have not yet seen a meaningful impact on client demand, which continues to show signs of stabilization, we have taken a measured and prudent approach to our outlook for the year.

雖然我們尚未看到對客戶需求產生重大影響，且客戶需求繼續顯示出穩定的跡象，但我們對今年的前景採取了謹慎和審慎的態度。

I'll now provide highlights of our first quarter performance. We reported revenue of $984.2 million in the first quarter of 2025, a 2.7% decrease compared to last year. On an organic basis, revenue declined 1.8%, driven by low single-digit organic decreases in each of our three business segments. Our first quarter revenue performance was above our February outlook for a mid-single-digit decline due primarily to the DSA segment's performance, for which I will provide more details shortly.

現在我將介紹我們第一季業績的亮點。我們報告 2025 年第一季的營收為 9.842 億美元，與去年相比下降 2.7%。從有機角度來看，收入下降了 1.8%，因為我們三個業務部門的有機收入都出現了低個位數的下降。我們第一季的收入表現高於 2 月預測的中等個位數下降，這主要歸因於 DSA 部門的表現，我很快就會提供更多詳細資訊。

By client segment, revenue for small and mid-sized biotech clients grew for a second consecutive quarter. Revenue for global biopharmaceutical clients declined in the first quarter, but this was due at least in part to the fact that we have not yet anniversaries the spending reductions which began in the second half of last year. Collectively, our global academic and government revenue increased slightly in the quarter.

按客戶細分，中小型生技客戶的收入連續第二季成長。全球生物製藥客戶的收入在第一季有所下降，但這至少部分是由於我們尚未紀念去年下半年開始的支出削減。總體而言，本季我們的全球學術和政府收入略有增加。

The operating margin was 19.1%, an increase of 60 basis points year-over-year. The improvement was primarily driven by the benefit of cost savings resulting from restructuring initiatives that promoted margin expansion in the DSA segment. Favorable mix in the DSA segment also contributed, as did unallocated corporate costs, which declined year-over-year as expected. Earnings per share were $2.34 in the first quarter, an increase of 3.1% from the first quarter of last year. In addition to operating margin improvement, below the line items, including reductions in the tax rate, interest expense and diluted shares outstanding were contributors to earnings growth.

營業利益率為19.1%，較去年成長60個基點。這項改善主要得益於重組措施帶來的成本節約，從而促進了 DSA 部門的利潤率擴大。DSA 部門的良好組合也做出了貢獻，未分配的企業成本也如預期那樣同比下降。第一季每股收益為2.34美元，較去年第一季成長3.1%。除了營業利潤率的提高之外，稅率、利息支出和稀釋流通股數的降低等線下項目也促進了獲利的成長。

Flavia will provide more details on these items.

弗拉維亞將提供有關這些物品的更多詳細資訊。

Based primarily on the first quarter DSA outperformance and our current visibility, balanced by a cautious approach to the second half of the year, we are modestly raising our 2025 revenue guidance by 100 basis points to a 2.5% to 4.5% decrease organically and our non-GAAP earnings per share guidance by $0.20 at midpoint to $9.30 to $9.80.

主要基於第一季 DSA 的優異表現和我們目前的可見性，加上對下半年的謹慎態度，我們將 2025 年收入預期小幅上調 100 個基點，有機下降 2.5% 至 4.5%，非 GAAP 每股預期中位數上調 0.20 美元至 9.30 美元。

I'd now like to provide you with additional details on our first quarter segment performance, beginning with the DSA segment's results. DSA revenue in the first quarter was $592.6 million, a decrease of 1.4% on an organic basis driven primarily by lower revenue for discovery services. DSA pricing improved slightly in the first quarter. This was primarily driven by favorable mix, specifically an increase in longer duration specialty studies. We do not believe this signals broader improvement in the spot pricing environment, which we would continue to characterize as stable overall.

現在，我想向您提供有關我們第一季度分部業績的更多詳細信息，首先是 DSA 分部的業績。第一季 DSA 收入為 5.926 億美元，有機下降 1.4%，主要原因是發現服務收入下降。第一季 DSA 定價略有改善。這主要是由有利的組合推動的，特別是長期專業研究的增加。我們認為這並不意味著現貨定價環境將得到更廣泛的改善，我們仍認為現貨定價環境總體上是穩定的。

Moving to the DSA demand KPIs on slide 19. The DSA backlog was $1.99 billion at the end of the first quarter, up slightly from $1.97 billion at year-end. You should note that beginning this quarter, we have disclosed our net bookings and net book-to-bill data. This is the first time we are providing this information because we believe it will provide additional transparency into these important KPIs, particularly when foreign exchange can have a notable impact on backlog, as it did in the fourth quarter.

轉到幻燈片 19 上的 DSA 需求 KPI。第一季末的DSA積壓訂單為19.9億美元，較去年末的19.7億美元略有成長。您應該注意到，從本季開始，我們已經揭露了淨預訂量和淨訂單出貨比數據。這是我們第一次提供這些信息，因為我們相信它將為這些重要的 KPI 提供額外的透明度，特別是當外匯可能對積壓訂單產生顯著影響時，就像在第四季度那樣。

As I mentioned earlier, we were pleased that the net book-to-bill improved to 1.04 times in the first quarter, above 1 times for the first time since the second half of 2022. This was primarily a result of quarterly net booking activity, which improved to $616 million, representing a more than 20% increase on both a year-over-year and sequential basis.

正如我之前提到的，我們很高興看到第一季的淨訂單出貨比提高到 1.04 倍，這是自 2022 年下半年以來首次超過 1 倍。這主要歸功於季度淨預訂活動增至 6.16 億美元，年比和季比均成長 20% 以上。

This improvement was driven by higher gross bookings, principally from global biopharmaceutical clients, as well as a continued decline in study cancellations moving towards targeted levels across all client segments, including small and midsize biotech’s.

這項改善主要得益於總預訂量的增加（主要來自全球生物製藥客戶），以及包括中小型生物技術公司在內的所有客戶群體的研究取消量持續下降並接近目標水準。

The incremental first quarter booking activity could largely be characterized for studies with quicker start dates, which is more reflective of our current shorter-term booking behaviors in the current market environment. We expect this will benefit revenue in the first half of this year, including the studies that were already started in the first quarter that led to the better-than-expected performance. Based on this trend, we are modestly increasing our full year revenue guidance for the DSA segment.

第一季預訂活動的增量很大程度上可以歸因於開始日期較短的研究，這更能反映我們在當前市場環境下的短期預訂行為。我們預計這將有利於今年上半年的收入，包括第一季已開始的研究，這些研究帶來了好於預期的業績。基於這一趨勢，我們適度提高了 DSA 部門的全年收入預期。

We now expect DSA organic revenue will decline in the mid-single-digit range, rather than our prior outlook of a mid- to high single-digit decline. As I mentioned, we expect the improved first quarter bookings will generate incremental revenue during the first half of the year, also augmented by the favorable study mix during the first quarter.

我們現在預計 DSA 有機收入將下降到中等個位數範圍，而不是我們先前預測的中等至高個位數的下降。正如我所提到的，我們預計第一季預訂量的增加將在今年上半年產生增量收入，同時第一季有利的研究組合也將增加收入。

At this point, given the current visibility, the generally conscious sentiment in the sector and our expectation that the study mix will normalize, we are not assuming that a similar bookings tailwind will continue to benefit second half revenue. However, as I said earlier, we have not seen any meaningful evidence of deterioration in our markets.

目前，考慮到當前的可見性、行業普遍的意識情緒以及我們對研究組合將正常化的預期，我們並不認為類似的預訂順風將繼續有利於下半年的收入。然而，正如我之前所說，我們還沒有看到任何表明我們的市場惡化的明顯證據。

The DSA operating margin increased 40 basis points year-over-year to 23.9% in the first quarter. The year-over-year improvement primarily reflected cost savings generated from our restructuring initiatives, as well as the favorable study mix in the first quarter. RMS revenue was $213.1 million, a decrease of 2.5% on an organic basis compared to the first quarter of 2024. RMS performed in line with expectations to start the year.

第一季度，DSA 營業利潤率年增 40 個基點，達到 23.9%。年比成長主要反映了我們重組措施產生的成本節約，以及第一季有利的研究組合。RMS 營收為 2.131 億美元，與 2024 年第一季相比有機下降 2.5%。RMS 今年年初的表現符合預期。

The year-over-year revenue decline was primarily driven by the timing of NHP shipments in China and lower revenue for the Cell Solutions business, partially offset by higher revenue for small research models in all geographic regions, driven primarily by higher pricing.

收入年減主要由於中國 NHP 出貨時間安排以及細胞解決方案業務收入下降，但所有地理區域小型研究模型收入增加（主要由於定價上漲）部分抵消了這一下降。

Small research models remain essential, low-cost tools for biomedical research, which enhances our ability to continue to realize price increases globally. However, there have been growing concerns from our academic and government clients that propose NIH budget cuts, and uncertainty in Washington could impact their future funding levels. We have not experienced any meaningful revenue loss related to NIH budgets to date, and first quarter revenue from our North American academic and government clients increased slightly.

小型研究模型仍然是生物醫學研究必不可少的低成本工具，這增強了我們繼續在全球範圍內實現價格上漲的能力。然而，我們的學術和政府客戶越來越擔心削減 NIH 預算，而華盛頓的不確定性可能會影響他們未來的資金水平。到目前為止，我們還沒有經歷與 NIH 預算相關的任何重大收入損失，而且第一季來自北美學術和政府客戶的收入略有增加。

As a reminder, this North American client base represents just over 20% of total RMS revenue, or approximately 6% of total company revenue. Any potential NIH budget cuts would be unlikely to impact client spending levels until later this year or into 2026.

提醒一下，這個北美客戶群佔 RMS 總收入的 20% 多一點，或占公司總收入的約 6%。任何潛在的 NIH 預算削減都不太可能在今年稍後或 2026 年之前影響客戶支出水準。

In addition, demand from early-stage biotech clients for our CRADL services is expected to be constrained this year due to their funding challenges. We believe this will slow the anticipated utilization of CRADL capacity during the year. As a result of these two potential headwinds, we are moderating our RMS outlook for the year to flat to slightly positive revenue growth on an organic basis compared to our previous expectation of low single-digit growth.

此外，由於資金挑戰，早期生物技術客戶對我們的 CRADL 服務的需求預計今年將受到限制。我們相信這將減緩今年 CRADL 容量的預期利用率。由於這兩大潛在不利因素，我們將今年的 RMS 預期調整為有機收入持平或略微正成長，而此前我們預期的是低個位數成長。

In the first quarter, the RMS operating margin decreased by 50 basis points to 27.1%. The decline was primarily a result of the lower NHP revenue, partially offset by the benefit of cost savings resulting from our restructuring initiatives.

第一季度，RMS營業利益率下降50個基點至27.1%。下降的主要原因是 NHP 收入較低，但重組措施帶來的成本節約效益部分抵消了這一下降。

Revenue for the manufacturing segment was $178.5 million, a 2.2% decrease on an organic basis from the first quarter of last year. The revenue decline was driven primarily by lower commercial revenue in the CDMO business and a slow start to the year for the biologics testing business. Overall, the manufacturing segment started the year in line with our expectations, and we are maintaining our prior outlook that Manufacturing revenue will be essentially flat on an organic basis in 2025.

製造部門的營收為 1.785 億美元，較去年第一季有機下降 2.2%。收入下降主要是由於 CDMO 業務的商業收入下降以及生物製劑檢測業務今年開局緩慢。總體而言，製造業今年的開局符合我們的預期，我們維持先前的預測，即 2025 年製造業收入將基本上保持有機持平。

As you know, first quarter testing volumes in the biologics testing business can fluctuate based on seasonal trends. The business had a stronger start last year. However, we continue to expect that biologics testing revenue will grow in 2025, and this outlook was supported by solid booking activity in the first quarter.

如您所知，生物製劑檢測業務第一季的檢測量會根據季節性趨勢而波動。去年該業務開局較強勁。不過，我們仍然預期生物製劑檢測收入將在 2025 年成長，這一前景得到了第一季穩健預訂活動的支持。

Our cell and gene therapy CDMO business was impacted by the lower revenue from two commercial cell therapy clients, which we discussed earlier in the year. The loss of commercial CDMO revenue reduced the manufacturing solutions growth rate by approximately 500 basis points in the first quarter and is expected to have a similar impact for the full year. We are continuing to make progress to enhance the quality of our CDMO operations.

我們的細胞和基因療法 CDMO 業務受到兩家商業細胞治療客戶收入下降的影響，我們在今年早些時候討論過這個問題。商業 CDMO 收入的損失導致第一季製造解決方案成長率下降了約 500 個基點，預計全年將產生類似的影響。我們正在不斷努力提高 CDMO 營運的品質。

We were also pleased to see that our gene therapy CDMO revenue grew in the quarter. We have a healthy pipeline of biotech clients with early-stage clinical candidates ready to help move the CDMO business forward and continue to believe attractive long-term growth opportunities exist. Offsetting these headwinds, the microbial solutions business reported another quarter of solid growth across its leading portfolio of rapid manufacturing quality control testing solutions, led by Accugenix microbial identification services.

我們也很高興地看到，我們的基因療法 CDMO 收入在本季有所成長。我們擁有健康的生物技術客戶管道，其中早期臨床候選藥物隨時準備好幫助推動 CDMO 業務的發展，並繼續相信存在有吸引力的長期成長機會。為抵消這些不利因素，微生物解決方案業務報告稱，其領先的快速製造品質控制測試解決方案組合（以 Accugenix 微生物鑑定服務為首）又實現了一個季度的穩健增長。

Endosafe also performed well as a result of growth for testing consumables, and a strong high throughput, automated NEXUS instrument placements last year are driving incremental cartridge demand. We expect microbial solutions will remain a stable source of high single-digit revenue growth for Charles River, demonstrating that clients are increasingly utilizing our comprehensive testing solutions to enhance their product release testing speed and efficiency.

Endosafe 的表現也很好，這得益於檢測耗材的成長，而去年強勁的高通量、自動化 NEXUS 儀器的投放推動了墨盒需求的增加。我們預計微生物解決方案將繼續成為 Charles River 高個位數收入成長的穩定來源，這表明客戶越來越多地利用我們的綜合測試解決方案來提高其產品發布測試的速度和效率。

The manufacturing segment's operating margin declined by 220 basis points to 23.1% in the first quarter of 2025 due principally to the impact of lower commercial revenue in the CDMO business. We believe the Manufacturing segment's margin will rebound as sales volume improves, particularly in the Biologics Testing business, and will move closer to the 30% level during the year.

2025 年第一季度，製造部門的營業利潤率下降 220 個基點至 23.1%，主要原因是 CDMO 業務商業收入下降的影響。我們相信，隨著銷售量的提高，尤其是生物製劑檢測業務的銷售量，製造部門的利潤率將會反彈，並將在今年內接近 30% 的水平。

Before I turn it over to Flavia, I would also like to discuss this morning's announcement regarding our actions to enhance value creation opportunities at the company in conjunction with our new shareholders, Elliott Investment Management. First, we are pleased to welcome Steven Barg, Abe Ceesay, Mark Enyedy and Paul Graves to our Board. Each brings significant professional and industry experience and will add fresh perspectives as we continue to execute our strategy and identify the best avenues for further growth and value creation.

在將麥克風交給弗拉維亞之前，我還想討論一下今天早上宣布的有關我們與新股東埃利奧特投資管理公司 (Elliott Investment Management) 共同採取行動以增強公司價值創造機會的公告。首先，我們很高興歡迎 Steven Barg、Abe Ceesay、Mark Enyedy 和 Paul Graves 加入我們的董事會。每個人都擁有豐富的專業和行業經驗，並將在我們繼續執行策略和尋找進一步成長和創造價值的最佳途徑時帶來新的視角。

I would also like to sincerely thank the four members of our Board who are not seeking reelection: Bob Bertolini, Debbie Kochevar, George Massaro and Richard Wallman. I appreciate the expertise and strategic counsel that each of you have provided to the company and to me over the many years that you have served on our Board, which have contributed to our enduring industry leadership, and we wish each of you the very best.

我還要真誠感謝董事會中四位不尋求連任的成員：Bob Bertolini、Debbie Kochevar、George Massaro 和 Richard Wallman。我感謝你們多年來在董事會任職期間為公司和我提供的專業知識和策略建議，這為我們持久的行業領導地位做出了貢獻，我們祝你們每個人都一切順利。

In addition, the Strategic Planning and Capital Allocation Committee of our Board will undertake a comprehensive strategic review of our business to evaluate initiatives to unlock additional value. We will report back on the outcome of the Board's review once complete. I look forward to working with each of our new and continuing Board members and the Elliott team as we focus on maximizing long-term value for our investors, clients and employees.

此外，董事會的策略規劃和資本配置委員會將對我們的業務進行全面的策略審查，以評估釋放額外價值的舉措。董事會審查完成後，我們將報告其結果。我期待與每一位新任和現任董事會成員以及 Elliott 團隊合作，致力於為我們的投資者、客戶和員工實現長期價值最大化。

I firmly believe the company shares are significantly undervalued, particularly after the FDA's announcement last month, so implementing additional value creation initiative is both necessary and timely. I'd like to thank our employees for their exceptional work and commitment and our clients and shareholders for their continued support.

我堅信該公司的股價被嚴重低估，尤其是在 FDA 上個月宣布這一消息之後，因此實施額外的價值創造計劃是必要且及時的。我要感謝我們員工的出色工作和奉獻，以及我們的客戶和股東的持續支持。

Now Flavia will provide additional details on our first quarter financial performance and updated 2025 guidance.

現在，Flavia 將提供有關我們第一季財務業績和更新的 2025 年指引的更多詳細資訊。

Thank you, Jim, and good morning. Before I begin, may I remind you that I'll be speaking primarily to non-GAAP results, which exclude amortization and other acquisition-related adjustments, costs related primarily to restructuring actions, gains or losses from certain venture capital and other strategic investments and certain other items. Many of my comments will also refer to organic revenue growth, which excludes the impact of acquisitions, divestitures and foreign currency translation.

謝謝你，吉姆，早安。在我開始之前，我想提醒大家，我將主要談論非公認會計準則的結果，其中不包括攤銷和其他與收購相關的調整、主要與重組行動相關的成本、某些風險資本和其他策略投資的收益或損失以及某些其他項目。我的許多評論還將涉及有機收入成長，其中不包括收購、資產剝離和外幣折算的影響。

We are pleased that our first quarter revenue and non-GAAP earnings per share exceeded our prior outlook. This outcome was primarily driven by better-than-expected DSA results and, to a lesser extent, a lower tax rate. These results also reflect the actions we have taken to protect the operating margin.

我們很高興看到第一季的收入和非公認會計準則每股收益超出了我們先前的預期。這一結果主要是由於 DSA 結果好於預期，以及較低的稅率（在較小程度上）。這些結果也反映了我們為保護營業利潤率所採取的行動。

For the past two years, we have taken aggressive actions through our restructuring program to reduce our cost structure by over 5% and align our infrastructure with the current demand, which contributed to the first quarter operating margin improvement and earnings growth, even with a modest revenue decline.

在過去兩年中，我們透過重組計劃採取了積極的行動，將成本結構降低了 5% 以上，並使我們的基礎設施與當前需求保持一致，這有助於第一季度營業利潤率的提高和盈利的增長，儘管收入略有下降。

We remain on track to deliver annualized cost savings of over $175 million in 2025 and approximately $225 million in 2026. We are also continuing to deploy capital in a disciplined and shareholder-focused manner. As announced last quarter, we're leveraging our solid annual free cash flow generation and completed the repurchase of $350 million in shares during the first quarter of 2025.

我們仍有望在 2025 年實現年度成本節約超過 1.75 億美元，在 2026 年實現年度成本節約 2.25 億美元。我們也將繼續以有紀律、以股東為中心的方式配置資本。正如上個季度宣布的那樣，我們正在利用穩健的年度自由現金流，並在 2025 年第一季完成了價值 3.5 億美元的股票回購。

For modeling purposes, including the stock repurchases to date, we will have slightly below 50 million average diluted shares outstanding for the full year. In just over two quarters, since the $1 billion stock repurchase program was authorized, we have repurchased nearly half of this amount. As Jim referenced, we currently believe the company is significantly undervalued, and we'll closely review opportunities for value creation, including additional stock repurchases.

為了建模目的，包括迄今為止的股票回購，我們全年流通股數將略低於 5,000 萬股。自 10 億美元股票回購計畫獲得批准以來，短短兩個多季度內，我們已經回購了近一半的金額。正如吉姆所提到的，我們目前認為該公司被嚴重低估，我們將密切審查創造價值的機會，包括額外的股票回購。

We also experienced a significant increase in quarterly free cash flow, with $112.4 million generated in the first quarter compared to $50.7 million last year. The improvement was primarily driven by lower performance-based cash bonus payments for 2024, which are paid in the first quarter, and by lower capital expenditures. CapEx was $59.3 million or approximately 6% of revenue in the first quarter compared to $79.1 million last year, reflecting the ongoing moderation of our capacity investments in the current demand environment. For the year, we expect that free cash flow will be $350 million to $390 million, and CapEx will be approximately $230 million, consistent with our prior outlook.

我們的季度自由現金流也大幅增加，第一季產生 1.124 億美元，而去年同期為 5,070 萬美元。業績改善的主要原因是 2024 年績效現金獎金支付減少（於第一季支付）以及資本支出減少。第一季的資本支出為 5,930 萬美元，約佔營收的 6%，而去年同期為 7,910 萬美元，這反映了我們在當前需求環境下對產能投資的持續放緩。我們預計今年的自由現金流將達到 3.5 億美元至 3.9 億美元，資本支出將達到約 2.3 億美元，這與我們先前的預測一致。

As Jim mentioned, we have modestly raised our revenue and non-GAAP earnings per share guidance. We now expect full year reported revenue will decline 3.5% to 5.5% and organic revenue will decline 2.5% to 4.5%. FX rates have been volatile since the election. And as a result, we now expect foreign exchange will represent an approximately 1% headwind to 2025 revenue based on recent bank forecasts, which is favorable to our prior outlook of a 1% to 1.5% headwind. Non-GAAP earnings per share are now expected to be in a range of $9.30 to $9.80.

正如吉姆所提到的，我們適度提高了收入和非公認會計準則每股收益預期。我們現在預計全年報告收入將下降 3.5% 至 5.5%，有機收入將下降 2.5% 至 4.5%。自大選以來，外匯匯率一直在波動。因此，根據最近的銀行預測，我們現在預計外匯將對 2025 年的收入造成約 1% 的阻力，這有利於我們先前預測的 1% 至 1.5% 的阻力。目前預計非公認會計準則每股收益將在 9.30 美元至 9.80 美元之間。

Our updated segment revenue outlook for 2025 can be found on Slide 36. We are raising our DSA outlook to reflect the solid first quarter performance, including improved bookings, which give us greater confidence in the near term. We're also tempering our IMS outlook, reflecting headwinds related to our CRADL business and potentially on our academic and government client base later in the year. Our Manufacturing outlook is unchanged on an organic basis. We expect the consolidated operating margin will decline 20 basis points to 50 basis points in 2025, or largely consistent with our prior outlook of modestly lower.

我們對 2025 年最新分部收入展望可參考投影片 36。我們上調了 DSA 預期，以反映第一季的穩健表現，包括預訂量的改善，這讓我們對短期內的業務更有信心。我們也在調整我們的 IMS 前景，以反映與我們的 CRADL 業務相關的不利因素，以及今年稍後可能對我們的學術和政府客戶群產生的不利因素。我們的製造業前景在有機基礎上保持不變。我們預計，到 2025 年，合併營業利潤率將下降 20 個基點至 50 個基點，與我們先前小幅下降的預測基本一致。

I will now provide details on the non-operating items that benefited our first quarter performance versus the prior year. On un-allocated corporate costs totaled $52.4 million in the first quarter, or 5.3% of revenue, compared to 6.2% of revenue last year. The decrease was primarily due to the benefits of cost savings actions. For the full year, we expect unallocated corporate costs will be in the range of 5% to 5.5% of total revenue.

我現在將詳細介紹使我們第一季的業績與去年同期相比有所提升的非經營項目。第一季未分配的企業成本總計 5,240 萬美元，佔營收的 5.3%，而去年同期為 6.2%。下降主要是由於成本節約措施帶來的好處。我們預計全年未分配的企業成本將佔總收入的 5% 至 5.5%。

The non-GAAP tax rate in the first quarter was 22.7%, representing a decrease of 60 basis points year-over-year. The first quarter tax rate was slightly favorable to our prior outlook, due primarily to the timing of the enactment of certain global minimum taxes, as well as higher R&D tax credits. For the full year, we continue to expect our non-GAAP tax rate will be in the range of 22.5% to 23.5%, consistent with our prior outlook.

第一季非公認會計準則稅率為22.7%，較去年同期下降60個基點。第一季的稅率略高於我們先前的預測，這主要是由於某些全球最低稅率的頒布時機以及更高的研發稅收抵免。就全年而言，我們繼續預期非公認會計準則稅率將在 22.5% 至 23.5% 之間，與我們先前的預測一致。

I'd like to briefly address the recent headlines around tariffs. Based on the current universal tariffs in place as of May 7, we expect a limited direct impact on an annual basis principally related to NHP supply and other study-related items, and we plan to offset most of these estimated tariffs by passing along the higher costs. This has been factored in our current guidance.

我想簡單談談最近有關關稅的新聞。根據截至 5 月 7 日實施的現行通用關稅，我們預計主要與 NHP 供應和其他研究相關項目相關的年度直接影響有限，我們計劃透過轉嫁更高的成本來抵消大部分估計的關稅。這已在我們的當前指導中得到考慮。

Total adjusted net interest expense was $26.5 million in the first quarter, essentially unchanged sequentially. For the full year, we expect total net interest expense will be at the lower end of our prior outlook of $112 million to $117 million. At the end of the first quarter, we had outstanding debt of $2.5 billion, with approximately 60% at a fixed interest rate compared to $2.2 billion at the end of the fourth quarter. As a result of the higher debt at the end of the first quarter, gross leverage increased to 2.5 times and net leverage increased to 2.4 times. The sequential increases in debt and the leverage ratios were primarily attributable to the short-term borrowings for stock repurchases, which we expect to largely repay through our cash flow over the course of the year.

第一季調整後淨利息支出總額為 2,650 萬美元，與上一季基本持平。我們預計全年淨利息支出總額將處於我們先前預測的 1.12 億美元至 1.17 億美元的低端。截至第一季末，我們的未償還債務為 25 億美元，其中約 60% 為固定利率債務，而第四季末為 22 億美元。由於第一季末負債增加，總槓桿率增至2.5倍，淨槓桿率增至2.4倍。債務和槓桿率的連續增加主要歸因於股票回購的短期借款，我們預計這些借款將在年內透過現金流主要償還。

A summary of our 2025 financial guidance can be found on slide 40. Looking ahead to the second quarter, we expect reported and organic revenue will decline at a low to mid-single-digit rate year-over-year. Earnings per share are expected to improve nicely from the first quarter level with a mid- to high single-digit sequential increase over the $2.34.

我們的 2025 年財務指導摘要可在第 40 張投影片上找到。展望第二季度，我們預計報告收入和有機收入將同比以低至中等個位數的速度下降。預計每股收益將較第一季水準大幅提升，季增中高個位數，超過 2.34 美元。

In summary, we were pleased that our financial performance in the first quarter benefited from the disciplined implementation of the cost-saving initiatives that we undertook, and we'll remain focused on continuing to evaluate additional opportunities to drive future savings and operating efficiencies. These actions are important not only to align our operations with current demand and to protect the operating margin, but also as a means to allow us to continue to invest in our businesses. We are committed to being at the forefront of scientific innovation, particularly as the industry continues to evolve.

總而言之，我們很高興看到第一季的財務表現得益於我們嚴格執行的成本節約舉措，我們將繼續專注於繼續評估推動未來成本節約和營運效率的更多機會。這些舉措非常重要，不僅是為了使我們的營運與當前需求保持一致並保護營業利潤率，而且也是為了讓我們能夠繼續投資於我們的業務。我們致力於走在科學創新的前沿，特別是在產業不斷發展的今天。

Our strategic investments and scientific expertise will position us to actively shape the changing regulatory landscape, while maintaining the highest standards of safety and efficacy. We will also evaluate all opportunities to unlock value with the support of our new and continuing Board members and Elliott Investment Management. We're proud of the foundation we've built, and we are energized by the opportunities ahead. Thank you.

我們的策略投資和科學專業知識將使我們能夠積極塑造不斷變化的監管格局，同時保持最高的安全性和有效性標準。我們還將在我們的新任和現任董事會成員以及 Elliott Investment Management 的支持下評估所有釋放價值的機會。我們為已經建立的基礎感到自豪，並為未來的機會感到振奮。謝謝。

That concludes our comments. We will now take your questions.

我們的評論到此結束。我們現在將回答大家的提問。

(Operator Instructions)

（操作員指示）

Max Smock, William Blair.

馬克斯史莫克、威廉布萊爾。

Maybe just starting off with the FDA guidance. And really on the news yesterday. I'm wondering if you have any thoughts on whether some of the mixed messaging from the FDA will prevent drug developers from really leaning into the guidance about reducing animal testing? I mean on one hand, there's been a lot of talk about improving the drug development process, making it easier to bring drugs to market. But then yesterday, we had the announcement of Dr. Prasad as Head of CBER, which -- the feedback we got was basically that, that sends a conflicting message based on some of his past comments.

也許只是從 FDA 指導開始。昨天的新聞確實報導了這一點。我想知道您是否認為 FDA 發出的一些混合訊息是否會阻止藥物開發人員真正遵循減少動物試驗的指導？我的意思是，一方面，人們有很多關於改進藥物開發流程的討論，以便更容易將藥物推向市場。但昨天，我們宣布普拉薩德博士為 CBER 負責人，我們收到的反饋基本上是，根據他過去的一些評論，這傳達了相互矛盾的信息。

So based on your conversations with pharma, in particular, could this be more like what we saw with the FDA Modernization 2.0 Act, where it didn't really lead to any real changes? Or is this more real to you?

那麼，根據您與製藥公司的對話，這是否更像我們所看到的 FDA 現代化 2.0 法案，它並沒有真正帶來任何真正的變化？或者這對你來說更真實？

Really interesting way you phrased that. It's difficult to predict. There's lots of changes at the FDA that, obviously, everybody has different opinions on the impact of those. A lot of -- there are less people, and there's new leadership. So it's difficult to judge where that is all going.

你這樣表述確實很有趣。這很難預測。FDA 發生了很多變化，顯然每個人對這些變化的影響都有不同的看法。很多——人員減少了，有了新的領導。因此很難判斷這一切將會走向何方。

I guess we would just say that this is really not new, this initiative. This has been going on for a significant amount of time. We and others have been participating in the development of NAMs. I think their focus on monoclonal antibodies is probably an intelligent place to test this and do a pilot. We're excited about the opportunity, however this develops, to be -- to lead the charge and sort of get our clients sync with the regulatory agencies, both in this country and in other places.

我想我們只能說，這項措施其實並不是什麼新鮮事。這種情況已經持續了相當長一段時間。我們和其他人一直在參與 NAM 的開發。我認為他們對單株抗體的關注可能是測試和試驗的一個明智之舉。我們對這個機會感到很興奮，無論事態如何發展，我們都能發揮領導作用，讓我們的客戶與這個國家和其他地方的監管機構保持同步。

So the fact that we all would like to see -- continue to refine it and reductions in utilization of research models, which has been going on for a significant amount of time. That will continue, but the science will be the principal driver of all of this. A lot of validation will be required, and we're going to play a key role in the validation.

因此，我們都希望看到的事實是——繼續完善它並減少研究模型的使用，這種情況已經持續了相當長一段時間。這種情況將會持續下去，但科學將是所有這一切的主要驅動力。這需要大量的驗證，我們將在驗證中發揮關鍵作用。

So I think your question is really around the pace and the cadence of this. Really, really difficult to say. I think if there were no changes in the FDA in terms of staffing or leadership, the validation methodology is significant and will take a meaningful amount of time, probably a little bit less with monoclonal antibodies, longer-term, NHP monoclonal antibody studies, which is where they started, and that's going to be sort of a proof of principle. So there'll be some development, and we will participate sort of regardless of what's going on at the FDA.

所以我認為你的問題實際上是關於這個的速度和節奏。真的，真的很難說。我認為，如果 FDA 在人員配備或領導層方面沒有變化，驗證方法將具有重要意義，並且將花費相當長的時間，而對於單株抗體、長期 NHP 單株抗體研究來說，驗證時間可能會短一些，這是他們開始的地方，這將是某種原理的證明。因此將會有一些進展，而且無論 FDA 發生什麼，我們都會參與。

Got it. Makes sense. Super helpful commentary. Maybe just following up, and I appreciate the detail you shared during the call around how alternative approaches are being used today. A lot of the inbounds we've gotten have been around biosimulation, in particular, PBPK and QSP.

知道了。有道理。超有用的評論。也許只是跟進一下，我很欣賞您在通話中分享的有關當今如何使用替代方法的細節。我們收到的許多資訊都與生物模擬有關，特別是 PBPK 和 QSP。

Just wondering if you can provide some more detail around how each of those offerings are being used currently and why they aren't being used more frequently already in preclinical? And then what you view as kind of the biggest hurdle before adoption of those biosimulation approaches moving forward? Thank you.

只是想知道您是否可以提供更多細節，說明這些產品目前是如何使用的，以及為什麼它們在臨床前階段沒有被更頻繁地使用？那麼，您認為採用這些生物模擬方法的最大障礙是什麼？謝謝。

I mean, a lot of those technologies are used successfully early on in drug discovery more than safety because you're looking for a single answer with something that you're questioning or prosecuting or developing. And by the way, I'd say that most of the drug companies, certainly, the large ones have their own proprietary technologies, and we've been using those for long periods of time and certainly not sharing them with others.

我的意思是，很多這些技術在藥物發現的早期就被成功使用，而不是在安全性方面，因為你正在尋找一個單一的答案來回答你正在質疑、起訴或開發的東西。順便說一句，我想說的是，大多數製藥公司，尤其是大型製藥公司，都擁有自己的專有技術，我們長期使用這些技術，並且絕對不會與其他人分享。

To move this into a regulated tox and be looking at the systemic reaction of a drug and the multi-organ reaction of a drug is really complicated science. And so trying to simulate things that happen inside of the human body as opposed to actually using a whole animal system to actually see how it works inside of a living mammalian system is quite different, and that's a huge leap of faith. So I think it's going to be a slow build. Some of those technologies are going to be beneficial. Some won't at all.

將其轉變為受管制的毒性並觀察藥物的全身反應和藥物的多器官反應是一門非常複雜的科學。因此，嘗試模擬人體內發生的事情，與實際使用整個動物系統來真正了解其在活體哺乳動物系統內如何運作是完全不同的，而且需要很大的信心。所以我認為這將會是一個緩慢的進程。其中一些技術將會是有益的。有些則根本不會。

Some of them will be beneficial to discovery and maybe not to safety. And I think that continued investment by us and others, and as I said, in a proprietary nature by our clients is necessary and important.

其中一些對發現有益，但可能對安全無益。我認為我們和其他人的持續投資，以及我所說的我們的客戶的專有投資是必要且重要的。

But in the final analysis, the FDA and all the other regulatory agencies are principally concerned about ensuring the safety of patients who take these drugs, and they're not going to cut any corners to do that, even with what looks like exciting technology. So it's going to be a slow continual build.

但歸根結底，FDA 和所有其他監管機構主要關心的是確保服用這些藥物的患者的安全，他們不會為了做到這一點而偷工減料，即使採用看似令人興奮的技術。所以這將是一個緩慢持續的建設過程。

Got it. Thanks again for taking our questions.

知道了。再次感謝您回答我們的問題。

Eric Coldwell, Baird.

埃里克·科德威爾，貝爾德。

I guess I'll stick with the same general line of questioning from Max. I'm curious on NAMs, you list upwards of a dozen areas of investment, things that you've been doing, $200 million of annualized revenue broadly defined. Where does Charles River -- where do you feel you stand out the most, where you're truly an industry thought leader, have maybe higher share versus competitors? And then what areas do you feel you're under-represented in today, but might step up investment? And I guess part C of that is, are you in a position or willing to interested in doing additional M&A to further supplement or complement what you're doing in the NAMs category? Thank you very much.

我想我會堅持 Max 提出的同樣的一般性問題。我對 NAM 很好奇，您列出了十幾個投資領域，您一直在做的事情，廣義定義的年收入為 2 億美元。Charles River 在哪裡——您認為您在哪些方面最突出，在哪些方面您是真正的行業思想領袖，與競爭對手相比，您的市場份額可能更高？那麼，您認為目前哪些領域的代表性不足，但可能會增加投資？我想其中的 C 部分是，您是否有能力或願意有興趣進行額外的併購，以進一步補充或完善您在 NAM 類別中所做的事情？非常感謝。

So I'm going to start with the last piece, Eric, because it's an interesting history lesson. So we bought our Microbial business almost 30 years ago as the only FDA-approved alternative to using research models. And it's been a very successful business for us, as you know. And we assumed and presumed that by now, 30 years later, we would have made, I don't know, dozens of acquisitions in this space, just because of the trajectory of new science and the necessity to be more sophisticated and have additional refinements.

所以我將從最後一部分開始，埃里克，因為這是一堂有趣的歷史課。因此，我們在近 30 年前收購了微生物業務，作為 FDA 批准的唯一研究模型替代方案。正如您所知，這對我們來說是一項非常成功的業務。我們假設並推測，到現在，30年後，我們將會在這個領域做出，我不知道，數十次收購，只是因為新科學的發展軌跡和更複雜和進一步改進的必要性。

And we see, I don't know, a dozen or so companies annually who come to us and you may have heard me say this before and say, we have a new technology that comes out of some August academic institution or the government and you bet a bias Charles River because we're going to -- this technology is going to put you out of business. It's usually the way the conversation starts.

每年都有大約十幾家公司來找我們，你可能以前聽我說過，他們說，我們有一項新技術，來自一些學術機構或政府，你敢打賭查爾斯河有偏見，因為我們會——這項技術會讓你們破產。這通常是對話開始的方式。

And the technologies always look interesting. But they're not practical, and they're not consistent, and they're not validatable and they're certainly not replacements for whole animal systems or even anything that could be augmented. So there are a few companies out there that we look at periodically, some that we've spoken to recently and not just because of this FDA thing.

而且這些技術總是看起來很有趣。但它們不實用，不一致，無法驗證，而且肯定不能取代整個動物系統，甚至不能取代任何可以增強的東西。因此，我們會定期關註一些公司，最近還與一些公司進行了交談，這不僅僅是因為 FDA 的事情。

And so I would say as a general proposition, we're quite interested in licensing or acquiring technologies that really work, really help accelerate drug development and don't cut any corners and risk patient safety. So very much committed to that. And we've done a whole host of things. We have bought some companies. We have a company called Retrogenix that has a cell microarray technology looking for off-target effects.

因此，我想說，總的來說，我們對授權或收購真正有效的技術非常感興趣，這些技術確實有助於加速藥物開發，並且不會偷工減料，不會危及患者安全。我非常致力於此。我們做了很多事。我們收購了一些公司。我們有一家名為 Retrogenix 的公司，該公司擁有一種尋找脫靶效應的細胞微陣列技術。

And off-target effects are things that are really, really important to find. We launched the pilot program to use virtual control groups instead of whole animals in some of our toxicology studies. We have a collaborative deal going which pairs a company's AI technology with our traditional methods to see whether we can accelerate helping our clients sign lead compounds. And we've had a couple of AI deals previously that didn't pan out very well. We'll certainly continue to look at those.

發現脫靶效應是非常非常重要的。我們啟動了試點計劃，在一些毒理學研究中使用虛擬對照組而不是整個動物。我們正在進行一項合作協議，將一家公司的人工智慧技術與我們的傳統方法相結合，看看我們是否可以加速幫助我們的客戶簽署先導化合物。我們之前也進行過幾筆人工智慧交易，但結果並不太好。我們肯定會繼續關注這些問題。

We also think that there's a way -- and we started this probably 15 years ago, and our clients were not really -- our clients had some problems with this, but we have years and years of toxicology data from thousands of clients. And we would like to use that on an anonymized basis, in other words, not indicating what the client is or what the drug was, but helping to design more predictive preclinical trials. So I think that that's something that we will lead -- can lead and will lead, I think we have the best technology doing that. I think that's underrepresented to go back to your question.

我們也認為有辦法——我們大概 15 年前就開始做這件事了，我們的客戶並沒有真正——我們的客戶對此有一些問題，但我們擁有來自數千名客戶多年的毒理學數據。我們希望以匿名的方式使用它，換句話說，不表明客戶是誰或藥物是什麼，但有助於設計更具預測性的臨床前試驗。所以我認為這是我們將要引領的——能夠引領並且將會引領的，我認為我們擁有最好的技術來做到這一點。我認為，回到你的問題，這還不夠。

So we have a stated commitment. We have an alternative methods advancement project. We have a Board committee that's focused on this. We have a bunch of KOLs that we bring in periodically to say, okay, what's the nature of the science, what's the best technology out there, what's practical, what's beneficial, what should we have in our portfolio. And we will continue to do that thoughtfully.

因此，我們有一個明確的承諾。我們有一個替代方法進步項目。我們有一個專門負責此事的董事會委員會。我們定期邀請一群關鍵意見領袖來告訴我們，科學的本質是什麼，目前最好的技術是什麼，什麼是實用的，什麼是有益的，我們的投資組合中應該包含什麼。我們將繼續認真地這樣做。

We will continue to spend money doing that without being wasteful. And again, first and foremost, we will continue to be all about the science and not in any way cause our clients to be risking patient safety.

我們將繼續花錢做這件事，但不會浪費。我再次強調，首先，我們將繼續堅持科學原則，絕不以任何方式危害我們客戶的病人安全。

Elizabeth Anderson, Evercore ISI.

伊麗莎白·安德森，Evercore ISI。

Hi guys, thanks so much for the question. I have two questions. My first question, maybe to continue on a theme is just -- in the short term, as you talk to customers since this FDA announcement, are they taking any actions like specifically now that they're starting to get more -- change their study procedures, et cetera? Or are they still sort of in digestion mode on this?

大家好，非常感謝您的提問。我有兩個問題。我的第一個問題，也許可以繼續討論一個主題——在短期內，自從 FDA 宣布這一消息以來，您與客戶交談時，他們是否採取了任何行動，比如具體來說，現在他們開始獲得更多——改變他們的研究程序等等？還是他們仍處於對此進行消化的狀態？

And then my second question, just as sort of we look at the strength in the bookings in the first quarter, that was nice to see. Were there any one timing items just in terms of are you still seeing sort of continue -- would you characterize that you're still seeing sort of a continued environment into the second quarter?

然後是我的第二個問題，正如我們所看到的，第一季的預訂量表現強勁，這是令人高興的。就您是否仍看到某種持續的情況而言，是否存在任何一個時間項目 - 您是否認為您仍會看到第二季度的某種持續環境？

So I think that our customers were pleased with the general tone of the FDA's pronouncement, albeit pretty dramatic from a headline point of view, that they want to participate in additional technologies and methodologies to accelerate getting the drugs to market, maybe reduce the cost and maybe have more sophisticated technologies. And as I said, a lot of them, I think, have their own technologies. I don't think we're going to see any sort of dramatic change in the methodology for doing safety studies. As you may or may not have read, the FDA's focus on longer-term NHP studies for monoclonal antibodies is something that they have been waiving the necessity to do those longer-term studies for some period of time. So the drug companies are already participating in that.

因此，我認為我們的客戶對 FDA 聲明的整體基調感到滿意，儘管從標題的角度來看相當引人注目，但他們希望參與額外的技術和方法來加速藥品的上市，或許可以降低成本，或許可以擁有更先進的技術。正如我所說，我認為他們中的許多人都有自己的技術。我認為我們不會看到安全研究方法有任何重大變化。您可能已經讀過或可能沒有讀過，FDA 專注於對單株抗體進行長期 NHP 研究，以至於他們在一段時間內放棄了進行這些長期研究的必要性。製藥公司已經參與其中了。

You get much less toxicity signals with monoclonal antibodies, and they tend to lend themselves to this sort of initiative. So that will save the drug companies time and money, and we're certainly happy to participate in that.

單株抗體產生的毒性訊號要少得多，而且它們往往適合這種主動性。這將節省製藥公司的時間和金錢，我們當然很樂意參與其中。

So I guess they're digesting it, I mean, the pronouncement doesn't fundamentally change anything that they're doing because as I've just said a couple of times with the previous questions, their job is to develop drugs that are effective against certain diseases, but ensure patient safety. So they'll do everything they can to do that. If they can do that partially with new technologies, that's great. We think that longer term, there'll be a hybrid approach where clients will submit animal data and NAMs data at the same time. And the combination of those will answer much of the questions that the FDA and other regulatory agencies have.

所以我猜他們正在消化它，我的意思是，這個聲明並沒有從根本上改變他們正在做的事情，因為正如我剛才在回答前面幾個問題時所說的那樣，他們的工作是開發對某些疾病有效的藥物，但要確保患者的安全。所以他們會盡一切努力去實現這個目標。如果他們能夠利用新技術部分來實現這一目標，那就太好了。我們認為，從長遠來看，將會採用一種混合方法，客戶將同時提交動物數據和 NAM 數據。這些因素的結合將解答 FDA 和其他監管機構的許多疑問。

So as I said, this will be a journey. These new technologies will be beneficial for certain types of drugs, particularly at the moment, monoclonal antibody, it's going to be a lot harder to go after small molecules or other large molecules like cell and gene therapy, there's just much less data around them, and the toxicity issue is much more complex to deal with and you really want to use the whole animal system to see what the multiple organ response is to the drug. So whether it's swallowed or injected. And your second question was about bookings? I think Flavia is going to answer that.

正如我所說，這將是一次旅程。這些新技術將有利於某些類型的藥物，特別是目前的單株抗體，追求小分子或其他大分子（如細胞和基因治療）將變得更加困難，圍繞它們的數據要少得多，而且毒性問題要復雜得多，你真的想使用整個動物系統來觀察多器官對藥物的反應。所以無論是吞服還是注射。您的第二個問題是關於預訂的嗎？我認為弗拉維亞會回答這個問題。

Yeah. Elizabeth, the strength of bookings in the first quarter was indeed encouraging. It's the first time that net book-to-bill went above 1 times for over two years. And there was really no one time impacting that. It was broadly based.

是的。伊莉莎白，第一季的預訂量確實令人鼓舞。這是兩年多來淨訂單出貨比首次超過 1 倍。確實沒有任何一次能夠影響這一點。它具有廣泛的基礎。

Gross bookings, particularly in large pharma, was strong, but cancellations were down across all client segments. So it's just really operationally strong, although still only one quarter.

總預訂量（尤其是大型製藥公司）表現強勁，但所有客戶群的取消量均下降。因此，儘管只持續了一個季度，但營運狀況確實非常強勁。

Ann Hynes, Mizuho Securities.

瑞穗證券的安‧海因斯 (Ann Hynes)。

Great. Thanks for all the details, very helpful. I guess like when I listened to your presentation, I feel like you don't think that this FDA issue will have a big negative impact on growth. So if I look at your long-term CAGR that you gave pre- this market downturn was 6% to 8% in DSA and RMS, assuming things like none of this market downturn has happened, what do you think, over time, this FDA change would -- how would that impact that kind of long-term growth algorithm for your company? That would be my first question, if at all.

偉大的。感謝您提供的所有詳細信息，非常有幫助。我想，當我聽您的演講時，我感覺您不認為這個 FDA 問題會對成長產生重大負面影響。因此，如果我看一下您在此次市場低迷之前給出的長期複合年增長率，即 DSA 和 RMS 為 6% 至 8%，假設沒有發生任何市場低迷的情況，您認為隨著時間的推移，FDA 的這一變化將如何影響貴公司的長期成長演算法？如果有的話，這將是我的第一個問題。

And then my second question, can you just comment on pricing? I know pricing has been a pressure, but it's definitely better than maybe what happened during the Great Recession. So can you tell us what happened during that period versus what pricing is doing now? That would be great.

我的第二個問題是，您能評論一下價格嗎？我知道定價一直是個壓力，但肯定比大衰退期間的情況要好。那麼，您能告訴我們那段時期發生了什麼，以及現在的價格狀況如何嗎？那太好了。

I think in terms of long-term growth trajectory and the impact of the FDA initiative, we have to spend some time refreshing our long-term growth rate. We've said that for a while. We have to take this new information into consideration with our own assessment, feedback from our clients and experts in the field. We'll have a refreshment of our long-term financial goals, probably when we have an Investor Day and have a comprehensive review and assessment of that. So I would stop short of throwing out numbers at this early date.

我認為，就長期成長軌跡和 FDA 舉措的影響而言，我們必須花一些時間來更新我們的長期成長率。我們已經說過這​​個一段時間了。我們必須結合自己的評估、客戶回饋以及該領域專家的意見來考慮這些新資訊。我們將更新我們的長期財務目標，可能是在我們舉辦投資者日並對其進行全面審查和評估時。因此，我不會在這麼早的時候就給出具體數字。

And do you want to take the pricing question?

您想回答定價問題嗎？

Sure. So yes, pricing environment improved slightly in the first quarter, driven primarily by mix, especially longer duration specialty studies where we tend to have a little bit more of, let's say, price power or not have to discount as much. So that was encouraging. And when you talk about comparing the price -- the current price environment to the great financial crisis, indeed, very, very different situation. Capacity has been better managed.

當然。所以是的，第一季的定價環境略有改善，主要受組合推動，特別是長期專業研究，我們往往擁有更多的價格權力或不必打那麼多折扣。這令人鼓舞。當你談到比較價格時——當前的價格環境與金融危機時期的價格環境，確實，情況非常非常不同。容量得到了更好的管理。

There's -- outsourcing is more prevalent now. So we're definitely not seeing the severity, I would say, of price pressure, price decline compared to great financial crisis.

現在外包更普遍了。因此，我想說，與金融危機相比，我們肯定沒有看到價格壓力和價格下跌的嚴重性。

Although as we said last year, we and others in the industry, as the demand contracted a bit, we had to selectively adjust pricing. So it's obviously not as strong as it had been during sort of COVID dates. But we were pleased that in the first quarter, things were stable from a spot perspective, and that mix helped with our price/mix results.

儘管正如我們去年所說的那樣，我們和業內其他人一樣，由於需求有所萎縮，我們不得不選擇性地調整價格。因此，它顯然不像 COVID 期間那麼強勁。但我們很高興看到，第一季從現貨角度來看情況穩定，這種組合有助於我們的價格/組合結果。

Great, thank you.

太好了，謝謝。

David Windley, Jefferies.

傑富瑞的戴維溫德利 (David Windley)。

Hi, thanks for taking my questions, Ann just asked this, I'm going to try to ask it in a slightly different way. But Flavia, you just walked through some of the history on pricing. I think if I remember your comments from last year correctly that sometime in the earlier part of the year was when pricing demand -- volume demand tended to drop or did drop and the price levels kind of dropped in the spot market. And you described that as kind of stepping down once and then continuing at a plateau. And then that going into the backlog and then that backlog beginning to produce revenue that lapped that lower -- or I guess, lapped the higher pricing, and you started to see lower pricing in the fourth quarter.

你好，謝謝你回答我的問題，安剛剛問了這個問題，我將嘗試用稍微不同的方式來問。但是弗拉維亞，你剛剛介紹了一些定價的歷史。我想，如果我沒記錯的話，您去年的評論是這樣的，在今年早些時候的某個時候，定價需求——批量需求趨於下降或確實下降，現貨市場的價格水平有所下降。您將其描述為先下降一次，然後繼續保持穩定。然後進入積壓訂單，然後積壓訂單開始產生收入，覆蓋較低的價格 - 或者我猜，覆蓋較高的價格，然後你開始在第四季度看到較低的價格。

So I guess what I'm trying to understand, because you had described that as a plateau, a lower plateau that we would see fairly consistently pressured pricing 4Q, 1Q, 2Q and forward. So I wanted to understand why that cadence is fluctuating, number one? And then number two, at SOT, the discussion there really was about another step down in price pressure by all players in the market. And so I just want to make sure I'm understanding or maybe I'm misunderstanding nuance or something like that? But we really did hear from a number of players that the price environment started 2025 more pressured than how it exited 2024. I appreciate comments on that.

所以我想我試著理解的是，因為你把它描述成一個平台，一個較低的平台，我們會看到第四季、第一季、第二季及以後的定價壓力相當持續。所以我想了解為什麼節奏會波動，第一？第二，在 SOT，討論的實際上是所有市場參與者再次降低價格壓力。所以我只是想確保我理解了，或者也許我誤解了細微差別或類似的東西？但我們確實從一些參與者那裡聽說，2025 年初的價格環境比 2024 年底的壓力更大。我很感謝對此的評論。

Sure, Dave. Yeah, let me take the second part of your question. So I cannot comment on others. But from our pricing perspective, I would say, as we indicated in our prepared remarks that the spot price is stable in the first quarter sort of compared to how we were exiting last year. And then just more broadly around price, you're correct in how you were interpreting the selective discounting that we started doing last year and how that would matriculate through the backlog and eventually, revenue.

當然，戴夫。是的，讓我來回答你問題的第二部分。所以我無法評論其他人。但從我們的定價角度來看，我想說，正如我們在準備好的評論中所指出的那樣，與去年同期相比，第一季的現貨價格比較穩定。然後更廣泛地討論價格，你對我們去年開始實行的選擇性折扣的解讀是正確的，以及這種折扣將如何透過積壓訂單並最終透過收入來實現。

I think what was positive and favorable, which may be a little bit of a surprise is the impact of mix, as I said before. So the favorability in the first quarter of price/mix being slightly improved is primarily driven by that mix impact.

我認為積極和有利的因素是混合的影響，這可能有點令人驚訝，正如我之前所說的那樣。因此，第一季價格/組合略有改善的有利因素主要是由組合影響所驅動。

Got it. And then if I could ask a separate topic. If you could remind us how the NIH funding and academic business, kind of how that funding flows? I think your -- maybe your direct NIH exposure is very, very low, and so maybe the direct risk is not really significant at all. I wonder if you have a clear assessment of how many customers, say, away from NIH are dependent on NIH funding?

知道了。然後我是否可以問一個單獨的話題。您能否提醒我們一下 NIH 的資金和學術業務狀況，以及資金是如何流動的？我認為你——也許你直接受到的 NIH 影響非常非常低，所以直接風險可能根本不大。我想知道您是否清楚地評估了有多少非 NIH 客戶依賴 NIH 資助？

And I think you've said in the past that, that funding tends to get let out on kind of three-year rolling basis. And I'm wondering if that provides some protection as it relates to the current NIH proposed cuts.

我認為您過去曾說過，資金往往以三年滾動的方式發放。我想知道這是否為目前 NIH 提議的削減提供了一些保護。

We have a couple of percentage points of our revenue directly related to NIH. They're a big client, principally of the Research Model business. We have a lot of long-term contracts. I can't predict what the government will do in terms of interrupting those contracts. Now we would hope not.

我們的收入中有幾個百分點與 NIH 直接相關。他們是一個大客戶，主要是研究模型業務的大客戶。我們有很多長期合約。我無法預測政府將如何終止這些合約。現在我們希望不是這樣。

And these are, in a lot of ways, the production of really specialized animal models for different agencies of NIH. Of course, there's been -- there's a lot of dialogue now about reductions of the NIH. So we would just be speculating.

從很多方面來說，這些都是為 NIH 的不同機構製作的真正專業的動物模型。當然，現在有很多關於削減 NIH 經費的討論。所以我們只是在推測。

We haven't heard anything, so we don't have any adverse impacts from the government yet. If you look at academic and government US, it's probably 20% of the RMS revenue. Again, that's indirect money from the government and other places. Again, we have no indications yet of what the impact might be. As we said, we're being very cautious in terms of our long-term guidance for this year, just assuming that we will have some adverse impacts from that.

我們還沒有聽到任何消息，所以我們還沒有受到政府的任何不利影響。如果你看看美國的學術和政府，它可能佔 RMS 收入的 20%。再說一遍，這是來自政府和其他地方的間接資金。再次，我們還沒有跡象表明會產生什麼影響。正如我們所說，我們對今年的長期指導非常謹慎，只是假設我們會受到一些不利影響。

We also said that since it's already May and nothing has happened yet, that whatever impact we have will probably be in the back half of this year or perhaps next year, but we would just be speculating.

我們也表示，由於現在已經是五月了，但還沒有任何動靜，因此我們可能要等到今年下半年或明年才會看到影響，但我們只是在推測。

So we'll let you all know what actually transpires as opposed to sort of predicting something that hasn't happened yet. And while we're obviously biased, we think that the contracts that we have directly with the government are really important for basic research and a whole bunch of different agencies, and it would be pretty shortsighted for the government to do anything with those, but we'll see.

因此，我們會讓大家知道實際發生的事情，而不是預測尚未發生的事情。雖然我們顯然有偏見，但我們認為我們與政府直接簽訂的合約對於基礎研究和一大批不同的機構來說確實非常重要，政府對這些合約採取任何行動都是非常短視的，但我們拭目以待。

And just to -- I think Jim quoted correctly, NIH Direct is 2% of total company. And then I think he talked about NIH plus academia being about 20% -- North America academia being 20% of RMS. That's about 6% of total revenue, total company, just to clarify.

我認為 Jim 的引用是正確的，NIH Direct 占公司總收入的 2%。然後我認為他談到了 NIH 加上學術界約佔 20%——北美學術界佔 RMS 的 20%。需要澄清的是，這約占公司總收入的 6%。

Great. Thank you.

偉大的。謝謝。

Michael Ryskin, Bank of America.

美國銀行的邁克爾·里斯金（Michael Ryskin）。

Great, thanks for taking the questions. I have two hopefully quick ones. One on the -- going back to the DSA strength and the bookings activity in the quarter. I just want to dive in a little bit deeper into the improvement you saw in 1Q. You specifically called out studies with quicker start dates reflective of the short-term booking behavior. Just -- I mean, could you expand on that?

太好了，感謝您回答這些問題。我有兩個希望很快的。一是回顧本季的 DSA 實力和預訂活動。我只是想更深入地探討一下您在第一季看到的改善。您特別提到了開始日期較短的研究，以反映短期預訂行為。只是——我的意思是，你能詳細說明一下嗎？

What do you think exactly drove that? And then just a question on, could that be sustainable for the rest of the year? Could that be a little bit of a pull forward versus 2Q? Just what are the dynamics there with pharma and biotech and DSA bookings?

您認為究竟是什麼原因導致了這個現象？然後有一個問題，這種情況在今年剩餘時間內能持續下去嗎？與第二季度相比，這是否會有所提前？製藥、生物技術和 DSA 預訂的動態究竟如何？

You've got clients that were anxious to start studies at a time where we had available capacity. So that worked really well. So quick starts was obviously extremely beneficial to the first quarter DSA results vis-a-vis our guidance. What we've said is we can't anticipate that, that will continue. It would be nice, but that would be -- we don't have any indications that, that will continue.

當我們有可用容量時，您的客戶就急於開始研究。所以效果確實很好。因此，與我們的指導相比，快速啟動顯然對第一季 DSA 結果極為有利。我們說過，我們無法預料這種情況會持續下去。這會很好，但是——我們沒有任何跡象表明這種情況會持續下去。

So I would say anything is possible, but that's definitely not our guidance. That -- we think that's a 1 quarter phenomenon. If that continues, we'll obviously let you folks know, but we don't anticipate that.

所以我想說一切都有可能，但這絕對不是我們的指導。我們認為這是季度現象。如果這種情況持續下去，我們當然會讓大家知道，但我們並不期待這種情況。

It's a little bit unusual. Again, it's tied to having the capacity. So that's a positive. But we may have used up the people that our large clients that want to start studies relatively quickly. That hasn't been our case for the last few years.

這有點不尋常。再次強調，這與能力有關。這是積極的。但我們可能已經用完了那些想要相對快速開始研究的大客戶的人力。過去幾年我們的情況並非如此。

It's a little bit unusual. So this is sort of backup work that people wanted to get done quickly. So not guiding to the continuation, I guess, is the punchline of this answer.

這有點不尋常。所以這是人們想要快速完成的備份工作。因此，我猜，不引導繼續下去是這個答案的妙處。

Okay. And then for my follow-up, in terms of the changes to the Board and the agreement with Elliott, realize you're just beginning the strategic review, but could you lay out what are the directions you will be looking at, whether -- what are you considering? Is it sale of part of the business divestment, any type of reorg, maybe potential whole company transaction? Just what are the different avenues you're exploring?

好的。然後，對於我的後續問題，關於董事會的變動和與 Elliott 的協議，意識到您才剛開始策略審查，但您能否說明一下您將要考慮的方向，您是否正在考慮什麼？是出售部分業務、剝離任何類型的重組，還是潛在的整個公司交易？您正在探索哪些不同的途徑？

So as you said, it hasn't started. We have a committee of the Board that has always existed, which is a Capital Allocation Committee. We do -- we've done always sort of some of the parts analysis, looked at our whole portfolio, looked at returns on our M&A and see whether we're happy with them. And we talk strategically about things that we should add to the portfolio.

正如你所說，它還沒有開始。我們有一個一直存在的董事會委員會，即資本配置委員會。我們確實——我們總是進行一些部分分析，審視我們的整個投資組合，審視我們的併購回報，看看我們是否對它們感到滿意。我們從戰略角度討論了應該添加到投資組合中的東西。

So we have the same committee. We have three new members. And those are three of the four new directors that we have, one of whom is actually a senior employee of Elliott. So -- and I'm on that committee and one of our former directors, but it's an opportunity to take a fresh look at the whole portfolio, the competitive dynamic of every business that we're in, where we think we're going, what the proper geographies are, what, if anything, is missing in the portfolio, and what, if anything, do we think is not contributing the way we would like.

所以我們有同一個委員會。我們有三位新成員。這是我們四位新董事中的三位，其中一位實際上是 Elliott 的高級員工。所以——我是該委員會的成員，也是我們的前董事之一，但這是一個重新審視整個投資組合、我們所在每項業務的競爭動態、我們認為我們的發展方向、適當的地理位置、投資組合中缺少什麼（如果有的話）以及我們認為哪些方面沒有按照我們希望的方式做出貢獻（如果有的話）的機會。

So it would be premature to sort of guess what the outcome would be. I think we're going to try to be open-minded and flexible and very objective about our decisions. I do think this committee is going to be hard at work evaluating and analyzing the entire company, both where we thought we would be and where we think those businesses are going, and we'll see what -- when we're done with that process, which we hope will be relatively quickly without rushing, we'll obviously let everybody know what our decisions are.

因此，現在猜測結果還為時過早。我認為我們將努力以開放、靈活和客觀的態度做出決定。我確實認為這個委員會將會努力評估和分析整個公司，包括我們預期的現狀以及我們認為這些業務將走向何方，我們將會看到——當我們完成這個過程時，我們希望這個過程會相對較快，但不著急，我們顯然會讓每個人都知道我們的決定。

Thanks so much.

非常感謝。

Justin Bowers, Deutsche Bank.

德意志銀行的賈斯汀·鮑爾斯。

Hi, good morning, everyone. So Jim, I wanted to go back to Mike's first question on the faster study starts. Is that something that you've seen continue through May, number one? Number two, I wasn't sure if you said that, that was isolated to large pharma or that was something that you saw more broadly? And then part three of that would just be any change in booking patterns or studies or programs for the large pharma customers? -- the outlook for the year.

大家好，早安。所以吉姆，我想回到麥克關於更快學習開始的第一個問題。首先，您是否看到這種情況持續到了五月？第二，我不確定您說的這種情況是否僅限於大型製藥公司，還是您看到的更廣泛的情況？那麼第三部分是針對大型製藥客戶的預訂模式、研究或計畫是否會有任何變化？ ——年度展望。

Yeah. So tough to predict what they'll be doing. The fast starts was sort of across the board. So clients have had things speed up were excited to get going. Revenue in the first quarter was stronger and up with our smaller biotech clients and down with pharma.

是的。很難預測他們會做什麼。快速啟動是全面的。因此，客戶對於事情的進展感到很興奮。第一季的收入更加強勁，小型生物技術客戶的收入上升，而製藥客戶的收入下降。

Bookings were stronger with pharma. Some of the pharma companies have worked through reduction in their infrastructures and portfolios. And I think a lot of the biotech companies are still struggling a bit with access to capital, having hope to presume that the capital markets will be open this year, and clearly, they're not.

製藥業的預訂量更為強勁。一些製藥公司已經透過減少基礎設施和投資組合來解決問題。我認為許多生技公司在獲取資金方面仍然有些困難，他們希望資本市場今年能夠開放，但顯然，他們並沒有。

So the fast starts is probably a one quarter phenomenon, but we'll see how that unfolds. As I said earlier, that's a bit unusual and really just sort of utilization of our excess capacity at the time when these guys had studies to do, but typically not something we see or that we would predict it would continue.

因此，快速啟動可能只是一個季度的現象，但我們將拭目以待其發展。正如我之前所說，這有點不尋常，實際上只是這些人進行研究時對我們過剩產能的一種利用，但通常不是我們所看到的情況，也不是我們預測會持續下去的情況。

And I think just to add, we -- these, let's say, faster study types, even though, again, we don't provide a lot of detail intra-quarter. So what we've seen in Q1 also does give us visibility to the second quarter. So I'd say the quicker starts are going to be affecting both Q1 and Q2, so the first half of the year. I think what Jim correctly said is we're not necessarily counting or assuming that that's going to continue given that current visibility is somewhat shorter, but it's certainly affecting positively the first half.

我想補充一點，我們——這些，可以說是更快的研究類型，儘管我們沒有提供季度內的許多細節。因此，我們在第一季看到的情況也確實讓我們對第二季有了了解。所以我認為更快的啟動將會影響第一季和第二季度，也就是今年上半年。我認為吉姆說得對，鑑於目前的能見度較短，我們不一定會計算或假設這種情況會持續下去，但它肯定會對上半年產生積極影響。

Okay. And then just pivoting a bit, there's been a decent uptick in licensing deals out of China over the last few quarters. And I was just hoping you could help us think through sort of the pushes and pulls on the business, both here and the US and then even locally in China, what are some of the opportunities and maybe threats there from that dynamic?

好的。稍微轉變一下，過去幾個季度，中國境外的授權交易出現了相當大的成長。我只是希望您能幫助我們思考我們在這裡、美國甚至中國本土的業務面臨的推動和拉動因素，這種動態會帶來哪些機會和威脅？

I mean, this is a continuing saga by the big drug companies, right, that smaller biotech companies are quite innovative and have become the discovery engines to big pharma. So you've seen lots of licensing and acquisitions of other drugs or entire companies in the US. And we're certainly beginning to see an intensification of that out of China. There's a fair amount of investment in biotech companies in China as well. So I think that will continue.

我的意思是，這是大型製藥公司的持續傳奇，對吧，小型生物技術公司非常具有創新精神，並已成為大型製藥公司的發現引擎。因此，您會看到美國有大量針對其他藥物或整個公司的許可和收購。我們確實開始看到中國的情況愈演愈烈。中國對生技公司的投資也相當多。所以我認為這種情況將會持續下去。

I think that's a smart thing for them to do.

我認為他們這麼做是明智之舉。

That doesn't -- neither of those has a particularly significant impact on us, one way or another. We have a research model business in China that continues to do really well, supporting the investment in biotech and big pharma in China. So I think that will continue. And we hope to continue to do work on the preclinical side for the larger companies when they make these acquisitions, whether the targets are Chinese or not. I mean that -- I think we get the preponderance of that work since we do so much work for pharma right now and most of the large biotech companies.

事實並非如此——無論如何，這些都不會對我們產生特別重大的影響。我們在中國擁有研究模型業務，並且持續表現良好，支持了中國對生物技術和大型製藥公司的投資。所以我認為這種情況將會持續下去。我們希望在大型公司進行收購時繼續進行臨床前方面的工作，無論目標公司是否為中國公司。我的意思是——我認為我們佔據了大部分工作，因為我們現在為製藥公司和大多數大型生物技術公司做了很多工作。

So that sort of cadence is definitely going to continue by the big drug companies, particularly as they face the impending patent cliff. It's better for them to make that in drugs that are further along than to start from scratch, although they'll do that as well.

因此，大型製藥公司肯定會繼續這種節奏，特別是當他們面臨即將到來的專利懸崖時。對他們來說，最好是在更先進的藥物中製造這種藥物，而不是從頭開始，儘管他們也會這樣做。

Kyle Crews, UBS.

瑞銀集團的凱爾克魯斯（Kyle Crews）。

Briefly going to the Manufacturing segment, could you discuss what you're seeing within the CDMO and the end market demand within that business and how you view Charles River's current competitive positioning there? And what happened with Biologics Testing in Q1?

簡要談談製造部門，您能否討論一下您在 CDMO 中看到的情況以及該業務的終端市場需求，以及您如何看待 Charles River 目前在該領域的競爭地位？那麼第一季的生物製劑測試情況如何？

Yeah. So Biologics Testing often has a seasonal impact and often a first quarter impact. So difficult to predict. And those -- that work comes in very quickly, almost without warning, and goes out very quickly. And as we said, we're quite confident and positive about the cadence of the Biologics business for the balance of the year.

是的。因此，生物製劑測試通常會受到季節性影響，通常會對第一季產生影響。很難預測。而且這些工作來得非常快，幾乎沒有任何預兆，而且很快就結束了。正如我們所說，我們對今年剩餘時間生物製劑業務的發展節奏非常有信心和樂觀。

So I think that business will be high.

所以我認為生意會很好。

On the CDMO cell therapy manufacturing business, we have a reduction in revenue from a couple of big commercial clients we've talked about significantly previously. I'd say that if you put those aside, the underlying demand is pretty good right now, both on the cell therapy side and on the gene therapy side as well. We have several clients that are in late-stage clinical and a couple that are talking to us about the commercialization of those drugs. We have really strong staff there in a facility that's in great shape. We've developed much more sophisticated capabilities to support the commercial clients, even though our revenue with them is declining.

在 CDMO 細胞療法製造業務方面，我們之前談到的幾個大型商業客戶的收入大幅減少。我想說，如果把這些放在一邊，目前潛在的需求相當好，無論是在細胞治療方面還是在基因治療方面。我們有幾個客戶處於後期臨床階段，還有幾個客戶正在與我們討論這些藥物的商業化。我們擁有非常優秀的員工和狀況良好的設施。儘管我們從商業客戶那裡獲得的收入正在下降，但我們已經開發了更複雜的功能來支援商業客戶。

And so we feel -- even though we said that the overarching demand for cell and gene therapy is not what we thought it would be when we first acquired these companies, I think that's just an overarching reality that there's a lot of concern about the safety profile of these drugs and they'll be slow to uptick, slow to get in the market. There's still a lot of them in the preclinical arena and moving into the clinic. So we're working hard on that business. We're committed to growing it. And as I said, the client base is reasonably strong right now.

因此，我們認為——儘管我們說過，細胞和基因治療的總體需求並不像我們最初收購這些公司時所想像的那樣，但我認為這只是一個總體現實，即人們對這些藥物的安全性有很多擔憂，而且它們會緩慢上升，緩慢進入市場。其中許多仍處於臨床前階段並正在進入臨床階段。所以我們正在努力開展這項業務。我們致力於發展它。正如我所說，目前的客戶群相當強大。

Patrick Donnelly, Citi.

花旗銀行的 Patrick Donnelly。

Hey guys, thanks for taking the questions. Jim, you talked a little bit about some of the trends in the DSA bookings side. Nice to see the book-to-bill over 1 times, to your point, for the first time in a couple of years. I guess now that it's over 1 times, is the expectation that it kind of stays here? I know you guys don't guide for quarterly book-to-bill. But what's the sense?

嘿夥計們，感謝你們回答問題。吉姆，您談到了 DSA 預訂方面的一些趨勢。很高興看到訂單出貨比超過 1 倍，正如您所說，這是幾年來的第一次。我想現在已經超過 1 倍了，是不是期望它會待在這裡？我知道你們不提供季度訂單出貨比指引。但這有什麼意義呢？

It sounds like you guys want to remain a little bit cautious with what's going on in the backdrop. But how do you think about just the book-to-bill trends going forward given what you're seeing on the bookings environment and the customer conversations?

聽起來你們想要對背景中發生的事情保持一點謹慎。但是，根據您所看到的預訂環境和客戶對話情況，您如何看待未來的訂單出貨趨勢？

I think we were thrilled by it and we have been anxiously awaiting a point where we got back here. We're also being particularly thoughtful, I think, and cautious about the fact that while we're thrilled with 1 quarter, it's only one quarter. And we'd have to see that sustained level for several quarters in a row before we really start to get a fundamental shift in the bookings trend. So we're hopeful that, that will happen.

我想我們對此感到非常興奮，並且一直焦急地等待著回到這裡。我認為，我們也特別深思熟慮，並且謹慎對待這樣一個事實：雖然我們對一個季度感到興奮，但這只是一個季度。我們必須看到這種水準連續幾季持續下去，預訂趨勢才會真正開始發生根本性的轉變。因此，我們希望這會發生。

And then Flavia, maybe just -- sorry, Jim, go ahead.

然後弗拉維亞，也許只是——對不起，吉姆，請繼續。

Go ahead, Patrick.

繼續吧，派崔克。

Yeah. Sorry, Flavia. And just on the margin side, I think previously you guys were talking about DSA down a bit this year. How are you thinking about just the moving pieces on the segment margins and the right way to think about the go forward? Thank you.

是的。對不起，弗拉維亞。就利潤率方面而言，我認為之前你們談到今年的 DSA 會略有下降。您如何看待細分邊緣上的移動部分以及如何正確思考未來的發展？謝謝。

Yeah. I think we're encouraged that the DSA performance in the first quarter started with a strong performance. As I said, we're being -- or Jim just said we're being cautious in the second half. On the other hand, we still predict that manufacturing is going to improve margin throughout the year. It was a little lighter in the first quarter, given the headwinds from CDMO as well as on a relative basis, a little slower start on Biologics Testing.

是的。我認為，我們很高興看到第一季 DSA 業績表現強勁。正如我所說，我們——或者吉姆剛才說我們在下半年會很謹慎。另一方面，我們仍然預測製造業的利潤率將全年提高。由於 CDMO 的阻力以及相對而言生物製劑測試的起步稍慢，第一季的業務略顯疲軟。

So I think when we think about the margin, I think we took all of you guys' input and tried to finesse for you a little bit and provide specificity on the margin guidance, minus 20 bps to minus 50 bps versus last year as opposed to modestly, still consistent with the prior guidance. We just tried to tighten it for you a little bit. But overall, we're pleased with the cost saving efforts that we put in place over the last 18 months to help protect the operating margin in the face of demand contraction, and we're going to continue to work hard to protect and enhance margin as much as possible.

因此，我認為，當我們考慮利潤率時，我們會採納你們所有人的意見，並嘗試為你們進行一些調整，並提供利潤率指導的具體信息，與去年相比，利潤率會下降 20 個基點到 50 個基點，而不是適度下降，但仍然與之前的指導保持一致。我們只是想幫您稍微收緊一點。但總體而言，我們對過去 18 個月採取的成本節約措施感到滿意，這些措施有助於在需求萎縮的情況下保護營業利潤率，我們將繼續努力盡可能地保護和提高利潤率。

Casey Woodring, JP Morgan.

凱西‧伍德林，摩根大通。

Great, thank you for taking my questions. Curious, what your updated expectations are for biotech and DSA this year, just given the weaker funding numbers to start the year? I think you said revenue for biotech clients grew in the quarter, and it seems like cancellations declined, but you said gross bookings were really led by large pharma.

太好了，謝謝你回答我的問題。好奇的是，鑑於今年年初的融資數量較弱，您對今年的生物技術和 DSA 有何最新預期？我認為您說過本季度生物技術客戶的收入有所增長，而且取消訂單的數量似乎有所下降，但您說過總預訂量實際上是由大型製藥公司推動的。

So just curious on biotech trends and the forward outlook here? And then on large pharma, how are your conversations going with these customers on potential tariffs and maybe just how you're thinking about that as a risk for this year? Thank you.

所以只是對生技趨勢和未來前景感到好奇？那麼，對於大型製藥公司，您與這些客戶就潛在關稅的對話進展如何？您如何看待這是今年的風險？謝謝。

Yeah. So on the second part of your question, Casey, on tariffs. Obviously, we continue to monitor the news like everybody else. And just yesterday, again, I think the sector was pressured given some indication that maybe tariffs were going to be back on the table. I think in terms of how that is translating to dialogue and activity with our pharma clients, nothing in particular.

是的。凱西，關於你問題的第二部分，關於關稅。顯然，我們會像其他人一樣繼續關注新聞。就在昨天，我認為該行業再次面臨壓力，因為有跡象表明關稅可能會重新擺上舞台。我認為就如何將其轉化為與我們的製藥客戶的對話和活動而言，沒有什麼特別的。

It's not necessarily impacting their R&D dollars as of now. I think everybody will continue to monitor that and hope that, I would say, good sense prevails and that the tariffs are not implemented, but we obviously can't control that.

到目前為止，這不一定會影響他們的研發資金。我認為每個人都會繼續關注這一點，並希望理智能夠佔上風，關稅不會被實施，但我們顯然無法控制這一點。

Tariffs impact directly to our business, as I said in my prepared remarks, is very modest, and we'll pass that small impact along.

正如我在準備好的演講中所說，關稅對我們業務的直接影響非常小，我們會將這種小影響轉嫁出去。

Jim, do you want to take on biotech trends in large pharma?

吉姆，你想了解大型製藥公司的生技趨勢嗎？

Yes. I mean, it's tough to predict. I mean, the funding situation is not improving for biotech. So I don't think we would anticipate any sort of dramatic change in the demand curve from them. They're going to do everything they can to get as many drugs into the clinic as possible.

是的。我的意思是，這很難預測。我的意思是，生物技術的資金狀況並沒有改善。因此我認為我們不會預期他們的需求曲線會發生任何劇烈的變化。他們將竭盡全力將盡可能多的藥物送入診所。

So they should continue to be an important part of our client base. I think the clients that want high-quality science and some regulatory expertise will continue to primarily use Charles River. I think that's worked really well for us. And we're being very thoughtful with the way we're pricing these studies. So I wouldn't anticipate any fundamental change.

因此他們應該繼續成為我們客戶群的重要組成部分。我認為那些需要高品質科學和一些監管專業知識的客戶將繼續主要使用 Charles River。我認為這對我們來說非常有效。我們在為這些研究定價時非常慎重。所以我預計不會有任何根本性的改變。

Charles Rhyee, TD Cowen.

查爾斯·瑞伊（Charles Rhyee），考恩（Cowen）TD。

Yeah, thank, thanks for taking the questions. Maybe I want to ask about DSA in a slightly different way. Just obviously, you mentioned earlier that you're seeing cancellation rates kind of continue to decline here. Can you talk about sort of risks to cancellations maybe ticking back up, given sort of the short time cycles and the quick study starts, it would seem that that's a much lower risk than it has been in the past? And then secondly, any update on -- for CDMO, the FDA's Form [483] would be helpful.

是的，謝謝，感謝您回答這些問題。也許我想以稍微不同的方式詢問有關 DSA 的問題。顯然，您之前提到過，這裡的取消率正在持續下降。您能否談談取消的風險是否會再次上升，考慮到時間週期短和研究開始快，現在的風險似乎比過去要低得多？其次，對於 CDMO，FDA 的表格 [483] 的任何更新都會有所幫助。

So cancellation rates -- cancellations are always part of our business, and have been for years and will continue to be. And so it's a normal part of the planning process and changes in priorities with our clients. And so we sort of build that into our business. And that's why we like the meaningful backlogs we can slot in new studies, and there's a penalty for cancellations by the way.

因此，取消率——取消始終是我們業務的一部分，多年來一直如此，並將繼續如此。因此，這是我們規劃過程和客戶優先事項變化的正常部分。因此我們將其融入我們的業務中。這就是為什麼我們喜歡有意義的積壓工作，以便我們可以將其納入新的研究中，順便說一下，取消積壓工作會受到懲罰。

I think the fact that cancellations have been coming down nicely for a while now, I think it's well over a year and sort of getting to target levels is really an important indication that the stability from a demand point of view in the market.

我認為事實上取消訂單的數量已經在一段時間內穩步下降，我認為這已經超過一年了，並且已經達到目標水平，這確實是一個重要的指標，表明從需求的角度來看市場是穩定的。

Obviously, we want to see that business grow again, but we're obviously delighted with the first quarter that the decline was much less than we had guided to and anticipated. So there's a fair amount of work out there, fast study starts, much more complex expensive studies.

顯然，我們希望看到業務再次成長，但我們對第一季的業績感到高興，因為降幅遠低於我們的預期。因此，還有相當多的工作要做，研究開始得很快，而且研究起來更加複雜、昂貴。

And since the backlogs are sufficient, but they haven't elongated to the point where there weren't studies associated with the booking slots. We don't see the cancellation rate that we saw. We had a backlog that got up to, I think, 18 months and clients were just cancelling and they got to that point because they were just saving the slot without having a corresponding study.

由於積壓的工作已經足夠，但還沒有延長到沒有與預訂時段相關的研究的地步。我們沒有看到我們看到的取消率。我認為，我們的積壓訂單已經長達 18 個月了，而客戶只是取消訂單，他們之所以會遇到這種情況，是因為他們只是在節省時間，而沒有進行相應的研究。

So I think we're past all of that, it's a much more measured and thoughtful approach. So again, we want to see that continue, but cancellation rates continue to come down, and that's definitely a positive for us.

所以我認為我們已經超越了這一切，這是一種更謹慎和深思熟慮的方法。所以，我們希望看到這種情況繼續下去，但取消率繼續下降，這對我們來說絕對是一件好事。

Then on the FDA CDMO 483, I think that was the second part of your question.

然後關於 FDA CDMO 483，我認為這是你問題的第二部分。

Yeah. So we have had the FDA in there with one of our commercial clients. We have been working really closely with the FDA back and forth to respond to their requests for things that they wanted to see improved. They wanted more information. They wanted more details.

是的。因此，我們讓 FDA 和我們的一位商業客戶一起去那裡。我們一直與 FDA 密切合作，以回應他們希望改進的事項的要求。他們想要更多資訊。他們想要更多細節。

I think that's going really well, continues to give us confidence if and when current clients move into a commercial milieu that our facilities will be in good shape to accommodate their needs.

我認為進展非常順利，這讓我們繼續充滿信心，如果現有客戶進入商業環境，我們的設施將能很好地滿足他們的需求。

Tejas Savant, Morgan Stanley.

摩根士丹利的 Tejas Savant。

Hey guys, good morning and thanks for the time here. Jim, a lot has been asked, but I do have a couple of cleanups on the FDA animal testing done. What fraction of MABs typically require these chronic NHP studies and what fraction were getting an FDA waiver?

大家好，早安，感謝你們抽出時間在這裡。吉姆，很多人問了這個問題，但我確實對 FDA 動物試驗做了一些清理工作。有多少 MAB 通常需要這些慢性 NHP 研究，又有多少 MAB 獲得了 FDA 豁免？

And secondly, just in terms of some of the early conversations you may have had with your customers. Is there a scenario in which pharma might prefer to run animal studies anyway so as to make sure we don't see a spike in Phase 1 or 2 failures in human trials down the road?

其次，就您與客戶進行的一些早期對話而言。是否存在這樣一種情況，即製藥公司可能更願意進行動物研究，以確保我們不會看到未來人體試驗第一階段或第二階段失敗的激增？

Yeah. So clients are going to continue to utilize the methodology that ensures patient safety. And so as we said in our prepared remarks, none of the NAMs can substitute for whole animal systems right now. You have this little narrow niche right now, which is longer-term monoclonal antibody studies for chronic studies. And the determination is that there's no need to continue to elongate those.

是的。因此客戶將繼續採用確保患者安全的方法。正如我們在準備好的演講中所說，目前沒有任何一個不結盟運動能夠取代整個動物系統。您現在有一個狹窄的小眾市場，即針對慢性研究的長期單株抗體研究。並且決心不再繼續延長這些。

So I think that's a thoughtful and smart thing to do. And as we said in the prepared remarks, they've actually been doing that for a period of time. So this pilot study will probably prove itself out, but they have to do that.

所以我認為這是一件深思熟慮且聰明的事。正如我們在準備好的發言中所說，他們實際上已經這樣做了一段時間。因此這項試點研究可能會證明其正確性，但他們必須這樣做。

So it's a very small proportion. It's about $50 million of our business that's sort of tied up in these longer-term chronic NHP studies for monoclonals and other large molecules and certainly small molecules, any sort of NAM -- fundamental NAMs technologies to be used with or in addition to with -- assuming that ever works, is way off. So this will be very slowly. I mean, the -- I don't know, so the FDA has given the drug companies permission to utilize more of these technologies, but they will take the responsibility upon themselves to ensure patient safety. And so regardless of what the regulatory agencies say either the science works or it doesn't.

所以這個比例非常小。我們的業務中約有 5000 萬美元與這些針對單株抗體和其他大分子以及小分子的長期慢性 NHP 研究有關，任何類型的 NAM - 基本 NAM 技術與其一起使用或補充 - 假設它有效，則還很遙遠。所以這會非常緩慢。我的意思是——我不知道，所以 FDA 已經允許製藥公司使用更多這些技術，但他們將承擔確保病人安全的責任。因此，無論監管機構怎麼說，科學要嘛有效，要嘛無效。

And that's why we think that hybrid approaches as we go forward will be beneficial. You get the benefit of some NAMs to answer certain questions. And when you're looking at a whole body systemic implications, you have a whole animal system combined with that.

這就是為什麼我們認為混合方法在未來將會是有益的。您可以利用一些 NAM 來回答某些問題。當你觀察整個身體系統的影響時，你會將整個動物系統與之結合。

So we're pretty confident that that's the way it's going to move. The extent to which technology develops in the future, that could be some sort of substitute having anything is possible, to take considerably long time and validation -- acceptance and validation by the regulatory agencies will be an important underpinning of all of this. And as we said earlier, we'll have a substantial role in leading that and helping our clients get to that point where they're either comfortable with NAMs as additional technologies or not.

所以我們非常有信心，事情將會朝著這個方向發展。未來技術發展的程度，可能會成為某種替代品，任何東西都有可能，需要相當長的時間和驗證——監管機構的接受和驗證將是所有這一切的重要基礎。正如我們之前所說，我們將發揮重要作用，引領這一進程，幫助我們的客戶達到他們願意或不願意接受 NAM 作為附加技術的程度。

Got it. That's helpful. And then just a quick follow-up on the strategic review here. How are you thinking about the time line? I know you mentioned sort of a relatively quick turnaround.

知道了。這很有幫助。然後，我們來快速跟進一下這裡的策略評估。您如何考慮時間軸？我知道您提到了相對較快的周轉。

But should we expect an update by the time of the next earnings call, for example, or perhaps even sooner? And then one for Flavia. I mean you've done a pretty good job with the cost cuts here. I think 5% -- over 5% of your cost structure has been eliminated. So in the context of the strategic review, are further cost cuts kind of like a lower priority item in your view, given how much work you've already done there?

但是，我們是否應該期待在下次收益電話會議之前，或者甚至更早的時候得到更新？然後還有一篇是給弗拉維亞的。我的意思是你們在削減成本方面做得相當不錯。我認為你們的成本結構中 5%——超過 5% 已被消除。那麼，在策略評估的背景下，考慮到您已經做了很多工作，您認為進一步削減成本是否是優先順序較低的專案？

And obviously, you don't want to impair your ability to lean into an eventual sort of robust market recovery here?

顯然，您不想削弱您最終實現強勁市場復甦的能力？

I'll take the first part. So the strategic review, we haven't started yet. We just signed this deal with Elliott. That committee is going to meet often. I don't know exactly what the cadence is yet.

我將選擇第一部分。因此，我們尚未開始戰略評估。我們剛剛與 Elliott 簽署了這項協議。該委員會將會經常開會。我還不知道具體的節奏是什麼。

And we're going to go really deep in all of our businesses. As I said earlier, in all the markets we're in, what's the competitive dynamic, how is the technology is developing, are we getting the returns on our acquisitions that we wanted, what's the margin profile look like and how do we continue to enhance and improve our portfolio.

我們將深入研究我們的所有業務。正如我之前所說，在我們所處的所有市場中，競爭動態如何，技術如何發展，我們是否獲得了想要的收購回報，利潤率狀況如何，以及我們如何繼續增強和改善我們的投資組合。

So that's going to take some time. So I don't know exactly when we'll have the punchline. We're going to move through it as swiftly as possible without rushing.

所以這需要一些時間。所以我不知道我們什麼時候才能找到笑點。我們將盡可能快速地完成它，但不要太著急。

I think it's extremely unlikely we'll have any punchlines by the next earnings call.

我認為，在下次收益電話會議之前，我們不太可能會得出任何妙語。

Yeah. And I think just in the cost savings to your point, Tejas, we are pleased with the actions we have taken so far. They were necessary, obviously, given the demand environment. But as I talked earlier in previous earnings calls, some of the savings that we have identified are durable. They're not going to -- we're not going to have to add back staffing for about $75 million of the $225 million.

是的。我認為，就您所說節省成本而言，Tejas，我們對迄今為止採取的行動感到滿意。顯然，考慮到需求環境，它們是必要的。但正如我之前在收益電話會議上所說的那樣，我們發現的一些節省是持久的。他們不會——我們不需要再為這 2.25 億美元中的約 7,500 萬美元增加員工。

And so I think we'll continue to take a look at opportunities to always be efficient. But to your point, I think we've done a lot on this space already. And so we'll update you all on the strategic review, as Jim said, once that's completed.

因此我認為我們會繼續尋找機會來提高效率。但就你的觀點而言，我認為我們已經在這個領域做了很多。正如吉姆所說，一旦戰略評估完成，我們將向大家通報最新情況。

Thank you so much. I appreciate it.

太感謝了。我很感激。

Matt Sykes, Goldman Sachs.

高盛的馬特·賽克斯 (Matt Sykes)。

Good morning. Thank you for taking our questions. [You will] on for Matt here. A lot has been asked, so I'll keep it to one. But within DSA, was the demand environment different between safety assessment and discovery work? It sounds like discovery or earlier stage work was a little weaker, but just want to unpack that? Thank you.

早安.感謝您回答我們的問題。 [你將] 代替馬特。已經有很多問題了，所以我只回答一個。但在 DSA 內部，安全評估和發現工作之間的需求環境是否不同？聽起來發現或早期階段的工作有點弱，但只是想解開這個謎團嗎？謝謝。

Discovery was weaker. And we're doing everything we can. We have a combined sales force selling across Discovery all the way through safety. So we have a much more integrated approach and we're optimistic that we're going to make more progress with our discovery clients. Having said that, we don't think that the large drug companies and certainly the smaller ones haven't swung back to significant amounts of investments in discovery.

發現較弱。我們正在盡一切努力。我們擁有一支聯合銷售隊伍，銷售 Discovery 品牌的所有安全產品。因此，我們採取了更全面的方法，並且我們樂觀地認為我們將與我們的發現客戶取得更大的進展。話雖如此，我們認為大型製藥公司，當然還有小型製藥公司，並沒有重新對研發進行大量投資。

I think they're still trying to get INDs filed and get this post-IND work into the clinic, and obviously, ultimately into the marketplace so they can fix the impending or protect themselves against the impending patent curve.

我認為他們仍在嘗試提交 IND，並將 IND 後的工作投入臨床，顯然最終投入市場，以便他們能夠解決即將出現的問題或保護自己免受即將出現的專利曲線的影響。

So at some point, that pendulum will swing back because if they don't invest aggressively in Discovery, they're going to have really lousy portfolios going forward. But yeah, we definitely had a weak quarter in Discovery. And hopefully, the enhanced sales focus will improve the -- we'll let you know.

因此，在某個時候，鐘擺會擺回來，因為如果他們不積極投資探索公司，那麼他們未來的投資組合將會非常糟糕。但是，是的，我們在探索號上確實度過了一個疲軟的季度。希望加強銷售重點能夠改善—我們會告訴您。

Got it. Thanks for all the color, guys.

知道了。謝謝你們帶來的所有色彩，夥伴們。

Luke Sergott, Barclays.

巴克萊銀行的盧克‧塞戈特 (Luke Sergott)。

Josh Waldman, Cleveland Research.

克利夫蘭研究公司的喬許‧沃爾德曼。

Hi, good morning. Thanks for taking the questions. This is Rob Cottrell. I wanted to come back to biotech, where you mentioned sales to small and midsized biotechs grew for the second consecutive quarter despite funding challenges. Was that the case across all three segments? And then any differences to call out in terms of midsized biotech versus small biotech? Thank you.

嗨，早安。感謝您回答這些問題。這是 Rob Cottrell。我想回到生技領域，您提到儘管面臨資金挑戰，但中小型生物技術的銷售額連續第二季實現成長。這三個部分都是這種情況嗎？那麼，中型生技公司和小型生技公司之間有什麼區別嗎？謝謝。

Yeah. We don't distill that finitely between small, mid- and large-sized biotech. I think we just tried to provide color in terms of large pharma and biotech. So to your point, for the second consecutive quarter, we saw growth there, which was encouraging.

是的。我們不會在小型、中型和大型生技公司之間進行有限的區分。我認為我們只是試圖為大型製藥和生物技術提供色彩。正如您所說，我們連續第二個季度看到了成長，這是令人鼓舞的。

We have no further questions at this time. I'll turn the call back over to Todd Spencer for closing remarks.

目前我們沒有其他問題。我將把電話轉回給托德·斯賓塞，請他做最後發言。

Great. Thank you. Thank you for joining us on the conference call this morning. We look forward to seeing you at upcoming investor conferences. This concludes the conference call.

偉大的。謝謝。感謝您參加今天早上的電話會議。我們期待在即將召開的投資者會議上見到您。電話會議到此結束。

Thank you. This does conclude today's Charles River Laboratories first-quarter 2025 earnings conference call. Thank you for your participation. You may now disconnect.

謝謝。這確實結束了今天的 Charles River Laboratories 2025 年第一季財報電話會議。感謝您的參與。您現在可以斷開連線。