Charles River Laboratories International Inc (CRL) 2022 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Charles River Laboratories Fourth Quarter and Full Year 2022 Earnings Conference Call. This call is being recorded. (Operator Instructions) I would now like to turn the conference over to our host, Todd Spencer, Vice President of Investor Relations. Please go ahead, sir.

女士們，先生們，感謝你們的支持，歡迎來到 Charles River Laboratories 2022 年第四季度和全年收益電話會議。此通話正在錄音中。 （操作員說明）我現在想將會議轉交給我們的主持人，投資者關係副總裁托德斯賓塞。請繼續，先生。

Thank you, and good morning, and welcome to Charles River Laboratories Fourth Quarter and Full Year 2022 Earnings and 2023 Guidance Conference Call and Webcast. This morning, I am joined by Jim Foster, Chairman, President and Chief Executive Officer; and Flavia Pease, Executive Vice President and Chief Financial Officer. They will comment on our results for the fourth quarter of 2022 as well as our financial guidance for 2023. Following the presentation, they will respond to questions.

謝謝，早上好，歡迎來到查爾斯河實驗室第四季度和全年 2022 年收益和 2023 年指導電話會議和網絡廣播。今天上午，董事長、總裁兼首席執行官吉姆·福斯特 (Jim Foster) 也加入了我的行列；執行副總裁兼首席財務官 Flavia Pease。他們將對我們 2022 年第四季度的業績以及我們 2023 年的財務指南發表評論。在介紹之後，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 webcast replay of this call will be available beginning approximately 2 hours after the call today and can be also accessed on our Investor Relations website. The replay will be available through the next quarter's conference call.

有一個與今天的評論相關的幻燈片演示，它將發佈在我們網站 ir.criver.com 的投資者關係部分。本次電話會議的網絡直播重播將在今天電話會議後約 2 小時開始提供，也可以在我們的投資者關係網站上訪問。重播將通過下一季度的電話會議提供。

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.

我想提醒你我們的安全港。根據 1995 年《私人證券訴訟改革法案》，我們對公司未來預期、計劃和前景所做的所有評論均構成前瞻性陳述。實際結果可能與所示結果存在重大差異。

During this call, we will primarily discuss non-GAAP financial measures, which we believe help investors gain a meaningful understanding of the core operating results and guidance. The non-GAAP financial measures are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. In accordance with Regulation G, you can find the comparable GAAP measures and reconciliations on the Investor Relations section of our website.

在本次電話會議中，我們將主要討論非 GAAP 財務指標，我們認為這有助於投資者對核心運營結果和指導有一個有意義的了解。非 GAAP 財務指標不應被視為優於或替代根據 GAAP 編制的運營結果。根據 G 條例，您可以在我們網站的投資者關係部分找到可比的 GAAP 措施和對賬。

I will now turn the call over to Jim Foster.

我現在將把電話轉給吉姆·福斯特。

Good morning. Before I speak about our strong fourth quarter results, I want to provide an update on the nonhuman primate or NHP supply situation. As many of you are aware, there has been an ongoing industry-wide investigation into NHP imports from Cambodia.

早上好。在我談論我們強勁的第四季度業績之前，我想提供有關非人類靈長類動物或 NHP 供應情況的最新情況。正如你們中的許多人所知，一直在對從柬埔寨進口的 NHP 進行全行業調查。

On February 17, we received a subpoena from the U.S. Department of Justice related to an investigation into the Cambodian NHP supply chain. We have been informed this investigation relates specifically to shipments of NHPs received by Charles River from our Cambodian supplier. We intend to fully cooperate with the U.S. government. Once the Department of Justice concludes its investigation, we believe it will find that any concerns with respect to Charles River are without merit.

2 月 17 日，我們收到了美國司法部的傳票，涉及對柬埔寨 NHP 供應鏈的調查。我們獲悉，這項調查特別涉及 Charles River 從我們的柬埔寨供應商處收到的 NHP 貨物。我們打算與美國政府充分合作。一旦司法部結束調查，我們相信它會發現對查爾斯河的任何擔憂都是毫無根據的。

As we have stated before, we are committed to ensuring our operations are fully compliant with all U.S. and international laws and regulations. And we maintain risk-based supplier due diligence, audit and management practices to help ensure the quality of our supplier relationships and compliance of applicable laws, including the status of the NHPs we import.

正如我們之前所說，我們致力於確保我們的運營完全符合所有美國和國際法律法規。我們保持基於風險的供應商盡職調查、審計和管理實踐，以幫助確保我們供應商關係的質量和適用法律的合規性，包括我們進口的 NHP 的狀態。

Based on ongoing investigations and a heightened focus on the Cambodia NHP supply chain, in recent months, we have voluntarily suspended planned future shipments of Cambodian NHPs until such time that we and the U.S. Fish and Wildlife Service can develop and implement new procedures to reinforce confidence that the NHPs we import from Cambodia are purpose-bred. This will take time to implement and the duration of which is unknown.

根據正在進行的調查和對柬埔寨 NHP 供應鏈的高度關注，最近幾個月，我們自願暫停計劃未來的柬埔寨 NHP 運輸，直到我們和美國魚類和野生動物管理局能夠制定和實施新程序以增強信心我們從柬埔寨進口的 NHP 是專門培育的。這將需要時間來實施，並且持續時間未知。

The investigation in current NHP supply situation will result in study delays in our Safety Assessment business. By way of background, NHPs are the most scientifically relevant large model for the regulatory required safety testing of biologic drugs as mandated by the FDA and other international regulatory agencies.

對當前 NHP 供應情況的調查將導致我們安全評估業務的研究延誤。作為背景，NHP 是 FDA 和其他國際監管機構強制要求的生物藥物監管要求安全測試的最科學相關的大型模型。

Biologic drugs cannot be approved for commercial use without NHPs. And given the proliferation of biologic drug development activity in recent years, NHPs have been in high demand. As an example, all of the COVID-19 vaccines developed in the United States and Europe utilized NHPs.

沒有 NHPs，生物藥物不能被批准用於商業用途。鑑於近年來生物藥物開發活動的激增，NHP 的需求量一直很大。例如，美國和歐洲開發的所有 COVID-19 疫苗都使用了 NHP。

In recent years, NHPs sourced from Cambodia have been responsible for approximately 60% of the NHPs supplied to the United States and to Charles River for drug research and development. While there is no other near-term global source to replace this supply, we are continuing to actively work to diversify our NHP supply chain.

近年來，來自柬埔寨的 NHP 約佔供應給美國和查爾斯河用於藥物研發的 NHP 的 60%。雖然近期沒有其他全球資源可以替代這種供應，但我們將繼續積極努力使我們的 NHP 供應鏈多樣化。

It's critical that we work diligently to resolve the NHP supply situation and collaborate with all agencies of the U.S. government, including the U.S. Fish and Wildlife Service, to restore this important supply chain because the U.S. pharmaceutical industry and the patients who need new life-saving treatments are counting on us.

至關重要的是，我們必須努力解決 NHP 的供應問題，並與包括美國魚類和野生動物管理局在內的美國政府所有機構合作，以恢復這一重要的供應鏈，因為美國製藥業和需要新的救命藥的患者治療指望我們。

The current Cambodian NHP supply constraints and the corresponding impact to our Safety Assessment business are expected to reduce our consolidated revenue growth forecast by approximately 200 to 400 basis points this year, resulting in organic revenue growth guidance of 4.5% to 7.5% for the total company.

目前柬埔寨 NHP 的供應限制以及對我們安全評估業務的相應影響預計將使我們今年的綜合收入增長預測降低約 200 至 400 個基點，從而使整個公司的有機收入增長目標為 4.5% 至 7.5% .

The non-GAAP earnings per share are expected to be in a range of $9.70 to $10.90 in 2023 with the wider ranges encompassing a number of scenarios related to the timing of the resumption of Cambodian NHP imports this year. The top end of our guidance ranges anticipate that we will have Cambodian NHPs available for studies in the fourth quarter, whereas the bottom end of our guidance assumes that we will have no Cambodian NHP imports for the remainder of 2023. In either case, we expect to begin to experience a more meaningful impact from NHP supply constraints in the second quarter.

預計 2023 年的非 GAAP 每股收益將在 9.70 美元至 10.90 美元之間，更廣泛的範圍包括與今年恢復柬埔寨 NHP 進口的時間相關的許多情景。我們指導範圍的高端預計我們將在第四季度有柬埔寨 NHP 可供研究，而我們指導的底端假設我們將在 2023 年剩餘時間內沒有柬埔寨 NHP 進口。無論哪種情況，我們預計在第二季度開始受到 NHP 供應限制的更有意義的影響。

In addition to NHP supply, several nonoperating items are significantly affecting the year-over-year earnings per share comparison in 2023, including higher interest expense, a higher tax rate and the divestiture of our Avian Vaccine business, which was completed in December. These items will generate a combined earnings per share headwind of $1.20 to $1.40 in 2023, partially offset by up to a $0.25 benefit from foreign exchange. Flavia will discuss these items in more detail shortly.

除了 NHP 供應外，還有幾個非經營性項目對 2023 年每股收益的同比比較產生了重大影響，包括更高的利息支出、更高的稅率以及去年 12 月完成的禽疫苗業務剝離。這些項目將在 2023 年產生 1.20 美元至 1.40 美元的合併每股收益逆風，部分被外匯帶來的高達 0.25 美元的收益所抵消。 Flavia 稍後將更詳細地討論這些項目。

Now I'll speak with you about an outstanding finish to another strong year for Charles River. We reported robust operating performance in 2022, highlighted by 13.4% organic revenue growth against the backdrop of escalating macroeconomic pressures.

現在，我將與您談談 Charles River 又一個強勁表現的出色表現。我們報告了 2022 年的強勁經營業績，在宏觀經濟壓力不斷升級的背景下，有機收入增長了 13.4%。

2022 performance demonstrates the continued execution of our strategy, which enables us to enhance our position as the scientific partner of choice to accelerate biomedical research and therapeutic innovation. Let me give you the highlights of our fourth quarter and full year performance.

2022 年的業績表明了我們戰略的持續執行，這使我們能夠鞏固我們作為首選科學合作夥伴的地位，以加速生物醫學研究和治療創新。讓我向您介紹我們第四季度和全年業績的亮點。

We reported record quarterly revenue of $1.1 billion in the fourth quarter of 2022, exceeding the $1 billion mark for the first time and representing an increase of 21.5% on an organic -- on a reported basis. Organic revenue growth of 18.8% was driven by increases from all 3 business segments with the most significant contribution from the DSA segment due to another robust performance in the Safety Assessment business.

我們報告稱，2022 年第四季度的季度收入達到創紀錄的 11 億美元，首次超過 10 億美元大關，有機增長 21.5%——據報導。 18.8% 的有機收入增長是由所有 3 個業務部門的增長推動的，其中 DSA 部門的貢獻最大，這是由於安全評估業務的另一項強勁表現。

In the second half, DSA organic growth rate rose to 23.6% as we exceeded the second half growth acceleration that we had forecast since the beginning of last year. For 2022, revenue was $3.98 billion with a reported growth rate of 12.3% and an organic growth rate of 13.4%. The revenue growth rates exceeded the top end of our guidance range by 140 basis points driven primarily by outperformance in both the Discovery and Safety Assessment businesses.

下半年，DSA 有機增長率升至 23.6%，因為我們超過了我們自去年年初以來預測的下半年增長加速。 2022 年收入為 39.8 億美元，報告增長率為 12.3%，有機增長率為 13.4%。收入增長率超過我們指導範圍的上限 140 個基點，這主要是由於發現和安全評估業務的出色表現。

The operating margin was 20.4% in the fourth quarter, a decrease of 50 basis points year-over-year driven primarily by the Manufacturing and RMS segments. For the full year, the operating margin was unchanged at 21%. We are pleased to have held the operating margin steady in a year with substantial cost inflation and the CDMO business generated significant margin pressure.

第四季度營業利潤率為 20.4%，同比下降 50 個基點，主要受製造和 RMS 部門的推動。全年營業利潤率保持在 21% 不變。我們很高興在成本大幅上漲且 CDMO 業務產生巨大利潤壓力的情況下，在一年內保持營業利潤率穩定。

Earnings per share were $2.98 in the fourth quarter, an increase of 19.7% from $2.49 in the fourth quarter of 2021. For the full year, earnings per share were $11.12, a 7.8% increase over the prior year.

第四季度每股收益為 2.98 美元，比 2021 年第四季度的 2.49 美元增長 19.7%。全年每股收益為 11.12 美元，比上年增長 7.8%。

We exceeded our last guidance range of $10.80 to $10.95 due primarily to the robust fourth quarter revenue growth, particularly in the DSA segment. We believe our 2022 performance thoroughly demonstrated the successful execution of our strategy to position Charles River as the nonclinical drug development partner of choice for our valued clients as well as the sustained pace of demand from these clients despite macroeconomic headwinds. Our exceptional market position, unique early-stage focus and our large diversified client base give us confidence that many of the underlying business trends will remain intact in 2023.

我們超出了 10.80 美元至 10.95 美元的最新指導範圍，這主要是由於第四季度收入增長強勁，尤其是在 DSA 領域。我們相信，我們 2022 年的業績充分證明了我們將 Charles River 定位為我們尊貴客戶的首選非臨床藥物開發合作夥伴的戰略的成功執行，以及儘管宏觀經濟逆風，但這些客戶的需求持續增長。我們卓越的市場地位、獨特的早期重點和龐大的多元化客戶群使我們相信，許多潛在的業務趨勢將在 2023 年保持不變。

I'd like to provide you with additional details on our fourth quarter segment performance and our expectations for 2023 beginning with the DSA segment's results. DSA revenue in the fourth quarter was $691.7 million or a substantial 26.5% increase on an organic basis.

我想向您提供有關我們第四季度部門業績的更多詳細信息，以及我們從 DSA 部門的業績開始對 2023 年的預期。第四季度 DSA 收入為 6.917 億美元，有機增長 26.5%。

The Safety Assessment business continued to be the principal driver of DSA revenue growth with significant contributions from study volume, pricing and NHP pass-throughs in order of magnitude. As we have often mentioned, our business is not linear. In this case, the record fourth quarter DSA revenue growth was driven by a combination of the current robust demand and pricing environment as well as the comparison to the fourth quarter of '21 when the business experienced some resource constraints, including staffing.

安全評估業務繼續成為 DSA 收入增長的主要驅動力，研究量、定價和 NHP 傳遞按數量級做出了重大貢獻。正如我們經常提到的，我們的業務不是線性的。在這種情況下，創紀錄的第四季度 DSA 收入增長是由當前強勁的需求和定價環境以及與 21 年第四季度的比較推動的，當時業務遇到一些資源限制，包括人員配置。

The Discovery Business Services growth rate also improved in the quarter. For the full year, DSA organic revenue growth was also a record 17.5%, exceeding our midterm's outlook. As of year-end, the DSA backlog has increased 32% year-over-year to $3.15 billion. The backlog remained robust in 2022 and continues to support a long growth runway and also normalized during the year as expected because the backlog duration stabilized after substantially elongating in prior years.

Discovery Business Services 的增長率在本季度也有所提高。全年，DSA 有機收入增長也達到了創紀錄的 17.5%，超過了我們的中期預期。截至年底，DSA 積壓訂單同比增長 32% 至 31.5 億美元。積壓在 2022 年仍然強勁，並繼續支持長期增長，並且在這一年也如預期正常化，因為積壓持續時間在前幾年大幅延長後趨於穩定。

We are continuing to see broad-based and sustained client demand across our Safety Assessment business as we have the staffing and capacity to accommodate this client demand. The current NHP supply situation may restrict the revenue growth rate and margin expansion in 2023, but the underlying strength and resilience of demand environment and pricing should afford us with healthy DSO growth opportunities once the NHP supply situation is resolved and we have an adequate supply of these large models.

由於我們擁有滿足客戶需求的人員配置和能力，我們將繼續看到我們安全評估業務中廣泛而持續的客戶需求。目前的 NHP 供應情況可能會限制 2023 年的收入增長率和利潤率擴張，但一旦 NHP 供應情況得到解決並且我們有足夠的供應，需求環境和定價的潛在實力和彈性應該會為我們提供健康的 DSO 增長機會這些大模型。

The Discovery Services business had a good quarter with improvement in the revenue growth rate from the third quarter level. Many of our clients who previously have lengthened the time frame to start new projects moved forward with their programs in the fourth quarter.

發現服務業務季度表現良好，收入增長率較第三季度有所改善。我們的許多客戶之前已經延長了啟動新項目的時間框架，並在第四季度推進了他們的計劃。

Discovery booking and proposal activity also support a healthy growth profile as we begin 2023. In order to strengthen our position as a single-source partner to support our clients' early-stage research needs, we continue to expand our discovery capabilities through our technology partnership strategy and through M&A.

從 2023 年開始，發現預訂和提案活動也支持健康的增長狀況。為了加強我們作為單一來源合作夥伴的地位，以支持我們客戶的早期研究需求，我們繼續通過技術合作夥伴關係擴大我們的發現能力戰略和併購。

We achieved both with SAMDI Tech, which we acquired in January. We established an initial partnership with SAMDI Tech in 2018, and we were able to validate their proprietary mass spectrometry technology for label-free, high-throughput screening with our clients.

我們通過 1 月份收購的 SAMDI Tech 實現了這兩個目標。我們於 2018 年與 SAMDI Tech 建立了初步合作夥伴關係，我們能夠與我們的客戶一起驗證他們用於無標記、高通量篩選的專有質譜技術。

During the partnership, we determined that SAMDI Tech's cutting-edge technology was increasingly favored by clients to accelerate their timelines and reduce the costs required to identify a lead drug candidate and make critical go/no-go decisions earlier. As a result of the successful partnership, we mutually agreed to have SAMDI Tech join Charles River.

在合作期間，我們確定 SAMDI Tech 的尖端技術越來越受到客戶的青睞，以加快他們的時間表並降低確定主要候選藥物和更早做出關鍵的通過/不通過決定所需的成本。由於成功的合作夥伴關係，我們共同同意讓 SAMDI Tech 加入 Charles River。

Partnerships and acquisitions like this advance our ongoing efforts to build our scientific expertise for the discovery of novel therapeutics and strengthen our discovery toolkit by adding cutting-edge capabilities to enable clients to work with us for a single project or on an integrated program in a flexible manner tailored to their specific outsourcing needs.

像這樣的合作夥伴關係和收購推動了我們不斷努力，以建立我們發現新療法的科學專業知識，並通過增加尖端能力來加強我們的發現工具包，使客戶能夠與我們合作進行單個項目或靈活的綜合計劃適合他們特定外包需求的方式。

The DSA operating margin was 26.3% in the fourth quarter, a 320 basis point increase from the fourth quarter of '21. For the year, the DSA operating margin increased by 160 basis points to 25.3%. Both increases were driven primarily by operating leverage associated with the meaningfully higher revenue in the Safety Assessment business.

第四季度 DSA 營業利潤率為 26.3%，比 2021 年第四季度增長 320 個基點。全年，DSA 營業利潤率增長了 160 個基點，達到 25.3%。這兩項增長主要是由與安全評估業務顯著增加的收入相關的運營槓桿推動的。

RMS' revenue in the fourth quarter was $196.1 million, an increase of 10.8% on an organic basis. For the year, RMS' organic revenue growth was 9%, squarely in line with our outlook of high single-digit growth in 2022.

RMS 第四季度的收入為 1.961 億美元，有機增長 10.8%。今年，RMS 的有機收入增長為 9%，完全符合我們對 2022 年實現高個位數增長的預期。

Accelerating growth for Research Model Services, particularly our CRADL initiative and research models in North America and China, drove the exceptional RMS' revenue growth rates for the fourth quarter and full year. We also continue to benefit from meaningful price increases, which were implemented in part to offset inflationary cost pressures. We expect similar trends will drive high single-digit organic growth again in 2023.

研究模型服務的加速增長，特別是我們在北美和中國的 CRADL 計劃和研究模型，推動了 RMS 在第四季度和全年的卓越收入增長率。我們還繼續受益於有意義的價格上漲，部分原因是為了抵消通脹成本壓力。我們預計類似的趨勢將在 2023 年再次推動高個位數的有機增長。

In the Research Model business, North America continued to generate strong revenue growth. And China, although reporting a double-digit increase, experienced a modest impact from an increase in COVID cases during the fourth quarter. The expansion of the central, southern and western regions of China are progressing well, and each new set is operational with 2 sites already shipping research models. This will enable us to continue to generate robust double-digit growth in China and gain additional market share.

在研究模型業務方面，北美繼續實現強勁的收入增長。而中國雖然報告了兩位數的增長，但在第四季度受到 COVID 病例增加的影響不大。中國中南部和西部地區的擴張進展順利，每套新機投入運營，2個站點已經出貨研究模型。這將使我們能夠繼續在中國實現兩位數的強勁增長，並獲得更多的市場份額。

Research Model Services also continued to perform well with broad-based growth across Insourcing Solutions and GEMS in the fourth quarter and for the year. Growth was primarily driven by Insourcing Solutions' CRADL operations or Charles River Accelerator and Development Labs, including last year's Explora acquisition.

Research Model Services 也繼續表現良好，Insourcing Solutions 和 GEMS 在第四季度和全年都有廣泛的增長。增長主要是由 Insourcing Solutions 的 CRADL 業務或 Charles River Accelerator and Development Labs 推動的，包括去年對 Explora 的收購。

Clients are increasingly adopting this flexible model to access vivarium space without having to invest in internal infrastructure. Explora continued to perform very well, and the combined CRADL footprint now encompasses 28 vivarium facilities totaling over 380,000 square feet of turnkey rental capacity. CRADL and Explora provide us with a new and unique pathway to connect with clients in earlier stages, enabling these clients to invest in the research and not in infrastructure, preferring to leverage Charles River's broader capabilities to continue to advance their research.

客戶越來越多地採用這種靈活的模型來訪問動物飼養空間，而無需投資內部基礎設施。 Explora 繼續表現出色，CRADL 的合併足跡現在包括 28 個動物飼養設施，總計超過 380,000 平方英尺的交鑰匙租賃能力。 CRADL 和 Explora 為我們提供了一種新的獨特途徑，可以在早期階段與客戶建立聯繫，使這些客戶能夠投資於研究而不是基礎設施，更願意利用 Charles River 更廣泛的能力來繼續推進他們的研究。

The RMS' operating margin declined by 420 basis points year-over-year to 22.7% in the fourth quarter and by 210 basis points to 25.2% in 2022. The declines were primarily attributable to the 53rd week, which has a greater impact on the RMS segment, headwinds from expansions of our CRADL and Explora operations and new RMS sites in China and also a modest COVID impact in China. We anticipate that each of these factors will either be eliminated or generate less of an impact in 2023, resulting in improvement in the RMS operating margin.

RMS 的營業利潤率在第四季度同比下降 420 個基點至 22.7%，在 2022 年下降 210 個基點至 25.2%。下降主要歸因於第 53 週，這對RMS 部門，我們的 CRADL 和 Explora 業務擴張以及在中國的新 RMS 站點帶來的不利因素以及 COVID 在中國的適度影響。我們預計這些因素中的每一個都將在 2023 年消除或產生較小的影響，從而提高 RMS 營業利潤率。

Manufacturing Solutions revenue was $212.1 million in the fourth quarter, a growth rate of 5.3% on an organic basis, and the full year organic growth rate was also 5.3%, in line with our mid-single-digit outlook for 2022.

第四季度製造解決方案收入為 2.121 億美元，有機增長率為 5.3%，全年有機增長率也為 5.3%，符合我們對 2022 年的中個位數展望。

The segment growth rate in 2022 was compressed by lower revenue in the CDMO business. The initiatives that we have implemented to improve the performance of our CDMO business continue to gain traction and earn positive feedback from clients.

2022 年的細分市場增長率受到 CDMO 業務收入下降的壓縮。我們為提高 CDMO 業務績效而實施的舉措繼續受到關注，並贏得了客戶的積極反饋。

Our creation of centers of excellence for cell therapies, viral vectors and plasmids has been well received. And coupled with our focus on CDMO business development efforts and investing in the commercial readiness of our operations, we are generating new client interest.

我們創建的細胞療法、病毒載體和質粒卓越中心廣受好評。加上我們專注於 CDMO 業務發展工作和投資於我們業務的商業準備，我們正在引起新的客戶興趣。

We have won over $100 million of new CDMO projects over the past 12 months and more than 2/3 of which are for our world-class cell therapy operations in Memphis. We believe that a stronger sales funnel will result in a gradual improvement in the CDMO performance during 2023 as the business returns to its targeted growth rates. We expect the CDMO business will drive a rebound in the Manufacturing segment organic growth rate to the low double digits in 2023.

在過去的 12 個月裡，我們贏得了超過 1 億美元的新 CDMO 項目，其中超過 2/3 用於我們在孟菲斯的世界級細胞治療業務。我們認為，隨著業務恢復到目標增長率，更強大的銷售渠道將導致 CDMO 業績在 2023 年逐步改善。我們預計 CDMO 業務將推動製造部門有機增長率在 2023 年反彈至較低的兩位數。

The Biologics Testing Solutions and Microbial Solutions businesses both performed very well in the fourth quarter, benefiting from robust client demand as the growth prospects for these legacy manufacturing quality control businesses remain strong. These businesses and the Manufacturing segment in total will continue to be principally driven by demand for biologic drugs, including cell and gene therapies and other complex biologics.

生物製品測試解決方案和微生物解決方案業務在第四季度均表現出色，受益於強勁的客戶需求，因為這些傳統製造質量控制業務的增長前景依然強勁。這些業務和製造部門總體上將繼續主要受到對生物藥物（包括細胞和基因療法以及其他復雜生物製劑）需求的推動。

Microbial Solutions had a strong quarter and full year, benefiting from broad-based growth across its Endosafe endotoxin testing and Accugenix microbial identification testing platforms. We are continuing to convert the marketplace to our more efficient and reliable quality control testing platform.

Microbial Solutions 季度和全年表現強勁，受益於其 Endosafe 內毒素檢測和 Accugenix 微生物鑑定檢測平台的廣泛增長。我們正在繼續將市場轉變為我們更高效、更可靠的質量控制測試平台。

The continued expansion of the installed base of instruments drives demand for the consumable cartridges and reagents, which provides a healthy recurring revenue stream. We believe Microbial Solutions' long-term growth potential continues to be approximately 10%, including in 2023.

儀器安裝基礎的持續擴大推動了對耗材盒和試劑的需求，從而提供了健康的經常性收入來源。我們認為微生物解決方案的長期增長潛力繼續保持在 10% 左右，包括 2023 年。

The Biologics Testing business reported an excellent fourth quarter and full year. Robust demand for cell and gene therapy testing services continue to be the primary growth factor as well as traditional biologics. And the business had an excellent year despite the moderation of COVID vaccine testing revenue during 2022.

生物製品測試業務第四季度和全年表現出色。對細胞和基因治療測試服務的強勁需求仍然是主要的增長因素以及傳統的生物製劑。儘管 2022 年 COVID 疫苗測試收入有所放緩，但該業務的這一年表現出色。

We have been successful in maintaining -- we have been successful at gaining business because of our extensive portfolio of services to support the safe manufacture of biologics. We believe cell and gene therapies will continue to be significant growth drivers over the longer term.

由於我們支持生物製品安全生產的廣泛服務組合，我們成功地維持了——我們成功地贏得了業務。我們相信，從長遠來看，細胞和基因療法將繼續成為重要的增長動力。

The Manufacturing segment's operating growth declined meaningfully in both the fourth quarter and full year to 25.3% and 28.8%, respectively. As has been the case all year, the decline was driven almost entirely by the underperformance of the CDMO business.

製造部門的營業增長率在第四季度和全年均顯著下降，分別降至 25.3% 和 28.8%。與全年情況一樣，下降幾乎完全是由於 CDMO 業務表現不佳所致。

Based on our expectations for the CDMO business, we believe the Manufacturing operating margin will improve meaningfully in 2023 to above the 30% level. As you know, there is inherent operating leverage in our businesses. So as project volumes improve in the CDMO business, we expect the margin profile will follow.

基於我們對 CDMO 業務的預期，我們認為製造業營業利潤率將在 2023 年顯著提高至 30% 以上的水平。如您所知，我們的業務具有固有的經營槓桿。因此，隨著 CDMO 業務的項目量增加，我們預計利潤率也會隨之提高。

In 2022, we celebrated our Charles River's 75th anniversary. We're delighted to have evolved from a small revolutionary research model company overlooking the Charles River to a leading global drug discovery and development partner, generating nearly $4 billion in annual revenue and helping to lead the biopharmaceutical industry's essential nonclinical drug development efforts.

2022 年，我們慶祝了 Charles River 成立 75 週年。我們很高興從一家俯瞰查爾斯河的小型革命性研究模式公司發展成為全球領先的藥物發現和開發合作夥伴，年收入近 40 億美元，並幫助引領生物製藥行業的基本非臨床藥物開發工作。

As we look to 2023, we continue to see a resilient funding environment, the continued renaissance in the golden age of scientific innovation, our clients' increasing use of strategic outsourcing and their need for enhanced efficiency and speed to market. Our core competencies, including our extensive scientific knowledge and our focus on preclinical R&D, are precisely tailored to these trends and make us an even more indispensable partner to advance our clients' life-saving therapies.

展望 2023 年，我們將繼續看到富有彈性的融資環境、科學創新黃金時代的持續復興、我們的客戶越來越多地使用戰略外包以及他們對提高效率和加快上市速度的需求。我們的核心競爭力，包括我們廣泛的科學知識和我們對臨床前研發的關注，正是針對這些趨勢量身定制的，使我們成為推進客戶挽救生命療法的更加不可或缺的合作夥伴。

I assure you that we will continue to proactively manage the NHP supply and reinforce our firm commitment to conducting ethical regulatory compliant business practices and to the humane treatment of the research model under our care.

我向您保證，我們將繼續積極主動地管理 NHP 供應，並加強我們對開展符合道德規範的商業行為以及對我們所關心的研究模型進行人道對待的堅定承諾。

To conclude, I'd like to thank our employees for their exceptional work and commitment and our clients and shareholders for their support.

最後，我要感謝我們的員工所做的出色工作和承諾，以及我們的客戶和股東的支持。

Now I'd like Flavia to give you additional details on our financial performance and 2023 guidance.

現在，我希望弗拉維亞向您提供有關我們財務業績和 2023 年指導的更多詳細信息。

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 our global efficiency initiatives, gains or losses from our venture capital and other strategic investments, a gain on the sale of the Avian Vaccine business and certain other items.

謝謝你，吉姆，早上好。在開始之前，請允許我提醒您，我將主要討論非 GAAP 結果，其中不包括攤銷和其他與收購相關的調整、主要與我們的全球效率計劃相關的成本、我們的風險投資和其他戰略的收益或損失投資、出售禽疫苗業務和某些其他項目的收益。

Many of my comments will also refer to organic revenue growth, which excludes the impact of acquisitions, divestitures, foreign currency translation and the 53rd week in 2022. My discussion this morning will focus primarily on our financial guidance for 2023.

我的許多評論還將提到有機收入增長，其中不包括收購、資產剝離、外幣換算和 2022 年第 53 週的影響。我今天上午的討論將主要集中在我們 2023 年的財務指導上。

We're very pleased with our fourth quarter results, which included revenue and earnings per share that outperformed our previous guidance, including quarterly revenue exceeding the $1 billion level for the first time. Our 2023 guidance ranges reflect multiple scenarios with regards to the estimated impact from the NHP supply constraint, as Jim outlined, the impact of which is expected to result in reported revenue growth of 1.5% to 4.5% and organic revenue growth of 4.5% to 7.5% in 2023.

我們對第四季度的業績感到非常滿意，其中包括超過我們之前指導的收入和每股收益，包括首次超過 10 億美元的季度收入。我們的 2023 年指導範圍反映了關於 NHP 供應限制的估計影響的多種情景，正如 Jim 概述的那樣，其影響預計將導致報告的收入增長 1.5% 至 4.5%，有機收入增長 4.5% 至 7.5% 2023 年的百分比。

Notwithstanding the NHP supply situation, our outlook reflects sustained underlying trends in most of our businesses and a resilient funding environment. We expect non-GAAP earnings per share between $9.70 and $10.90, reflecting meaningful headwinds associated with both NHP supply and nonoperating items.

儘管 NHP 供應情況不佳，但我們的前景反映了我們大多數業務的持續潛在趨勢和富有彈性的融資環境。我們預計非 GAAP 每股收益在 9.70 美元至 10.90 美元之間，反映出與 NHP 供應和非經營項目相關的重大不利因素。

I will not provide too many more comments on the NHP supply impact since Jim covered it. So I'll focus my comments on the other headwinds, which include the impact of the Avian Vaccine divestiture, a higher tax rate and increased interest expense.

自從吉姆報導以來，我不會就 NHP 供應影響提供太多評論。因此，我將把我的評論集中在其他不利因素上，包括剝離禽疫苗的影響、更高的稅率和增加的利息支出。

In combination, these nonoperating headwinds will reduce earnings per share by approximately $1.20 to $1.40 for the year, partially offset by an FX benefit to earnings per share of up to $0.25 in 2023. These items will reduce earnings per share growth by nearly 10% at midpoint.

綜合起來，這些非經營不利因素將使全年每股收益減少約 1.20 美元至 1.40 美元，部分被 2023 年每股收益的外匯收益高達 0.25 美元所抵消。這些項目將使每股收益增長減少近 10%中點。

I'd like to provide some additional details on the 3 nonoperating items that we expect will generate headwinds for our financial performance in 2023. First, we completed the Avian Vaccine divestiture in December as expected. The transaction will reduce 2023 revenue by approximately $80 million and non-GAAP earnings per share by approximately $0.25 net of the interest expense benefit since we used the proceeds to repay debt.

我想提供一些關於我們預計將對我們 2023 年的財務業績產生不利影響的 3 個非經營性項目的更多詳細信息。首先，我們按預期在 12 月完成了 Avian Vaccine 資產剝離。該交易將使 2023 年收入減少約 8000 萬美元，非 GAAP 每股收益減少約 0.25 美元（扣除利息支出收益），因為我們將所得款項用於償還債務。

Second, the non-GAAP tax rate is expected to move to the top of our long-term low 20% range to 22.5% to 23.5% in 2023, representing a nearly 400-basis-point increase at midpoint compared to the 2022 tax rate of 19.2%. The increase will be primarily driven by a year-over-year reduction in the excess tax benefit related to stock compensation as a lower stock price will generate less of a benefit in 2023 compared to the prior year as well as discrete tax benefits in 2022 that are not expected to reoccur this year. The higher tax rate is expected to reduce 2023 earnings per share by $0.50 to $0.65 and the earnings growth rate by over 500 basis points at midpoint.

其次，預計 2023 年非美國通用會計準則稅率將升至我們 20% 的長期低區間的頂部，達到 22.5% 至 23.5%，與 2022 年的稅率相比中點增加近 400 個基點19.2%。這一增長主要是由於與股票薪酬相關的超額稅收優惠同比減少，因為與上一年相比，較低的股價將在 2023 年產生較少的福利，以及 2022 年的離散稅收優惠預計今年不會再發生。較高的稅率預計將使 2023 年每股收益減少 0.50 美元至 0.65 美元，並且中點收益增長率將減少 500 多個基點。

Finally, total adjusted net interest expense in 2023 is expected to increase to a range of $133 million to $137 million compared to $105 million last year. We expect year-over-year increase will be driven by higher variable interest rates primarily as a result of the Federal Reserve's actions, partially offset by repayment of debt.

最後，預計 2023 年調整後的淨利息支出總額將從去年的 1.05 億美元增至 1.33 億美元至 1.37 億美元。我們預計同比增長將主要由較高的浮動利率推動，這主要是由於美聯儲的行動，部分被償還債務所抵消。

We anticipate the higher interest expense will create an earnings per share headwind of $0.45 to $0.50 and reduce the earnings growth rate by at least 400 basis points. As we mentioned last quarter, we entered into an interest rate swap agreement effectively locking in a fixed rate for 2 years on $500 million of our revolving credit facility.

我們預計更高的利息支出將造成每股收益 0.45 美元至 0.50 美元的逆風，並將收益增長率降低至少 400 個基點。正如我們在上個季度提到的那樣，我們簽訂了一項利率互換協議，有效地鎖定了我們 5 億美元循環信貸額度的固定利率 2 年。

At year-end, approximately 3/4 of our $2.7 billion debt was at a fixed rate. We believe the Federal Reserve will increase rates in the near term, and our outlook accommodates an additional 100 basis point increase in rates in 2023 beyond the recently announced February increase.

年底時，我們 27 億美元的債務中約有 3/4 是固定利率債務。我們認為美聯儲將在短期內加息，我們的展望表明在最近宣布的 2 月加息之後，2023 年利率將再加息 100 個基點。

At the end of the fourth quarter, our gross and net leverage ratios were approximately 2.2x and 2.1x, respectively. This is a meaningful decline from the third quarter due in part to a cash gain on the Avian divestiture. We continuously evaluate our capital priorities and as always, intend to deploy capital to the areas that we believe will generate the greatest returns. Our outlook assumes an average diluted share count of approximately 51.5 million to 52 million shares outstanding in 2023.

第四季度末，我們的總槓桿率和淨槓桿率分別約為 2.2 倍和 2.1 倍。與第三季度相比，這是一個有意義的下降，部分原因是 Avian 資產剝離的現金收益。我們不斷評估我們的資本優先事項，並一如既往地打算將資本部署到我們認為會產生最大回報的領域。我們的展望假設 2023 年平均稀釋後流通股數約為 5150 萬至 5200 萬股。

From a segment perspective, our 2023 revenue growth outlook reflects sustained client demand trends, offset by the NHP supply impact in the DSA segment. Similar to the prior year, the RMS segment is expected to achieve high single-digit organic revenue growth, the result of continued robust demand for research models and associated services. As a reminder, the Cambodian NHP supply situation does not have an impact on our RMS segment as these large models are sourced and used to support our Safety Assessment operation.

從細分市場的角度來看，我們 2023 年的收入增長前景反映了持續的客戶需求趨勢，被 DSA 細分市場的 NHP 供應影響所抵消。與上一年類似，RMS 部門預計將實現高個位數的有機收入增長，這是對研究模型和相關服務的持續強勁需求的結果。提醒一下，柬埔寨 NHP 的供應情況不會對我們的 RMS 部門產生影響，因為這些大型模型的採購和使用是為了支持我們的安全評估操作。

For the DSA segment, we expect the organic growth rate will be between low to mid-single digits based on our NHP supply assumptions around the timing of the resumption of imports. The Manufacturing segment is expected to generate low double-digit organic revenue growth with the increase from the 2022 growth rate principally driven by the expected rebound in the CDMO performance during the year.

對於 DSA 部分，根據我們對恢復進口時間的 NHP 供應假設，我們預計有機增長率將介於中低個位數之間。製造部門預計將產生低兩位數的有機收入增長，與 2022 年的增長率相比有所增長，這主要是由於年內 CDMO 業績的預期反彈。

While foreign exchange was a 350-basis-point headwind in 2022, the weakening of the U.S. dollar since November is expected to result in a slight FX benefit of up to 50 basis points to revenue growth in 2023, assuming near current foreign exchange rates. This will drop down to a more meaningful contribution to the bottom line and is projected to generate up to a $0.25 earnings per share benefit due largely to movements in the Canadian dollar.

雖然外彙在 2022 年是一個 350 個基點的逆風，但假設當前匯率接近，美元自 11 月以來的疲軟預計將為 2023 年的收入增長帶來高達 50 個基點的輕微外匯收益。這將對利潤做出更有意義的貢獻，預計將產生高達 0.25 美元的每股收益，這主要是由於加元的走勢。

You may recall, in Canada, we invoiced most of our revenue in U.S. dollars, but essentially all of our costs are in current Canadian dollars. We have provided information on our 2022 revenue by currency and the foreign exchange rates that we are assuming for 2023 in our slide presentation.

您可能還記得，在加拿大，我們的大部分收入都以美元開具發票，但基本上我們所有的成本都以現價加元計價。我們在幻燈片演示中提供了按貨幣分類的 2022 年收入信息和我們假設的 2023 年外匯匯率。

For the operating margin, we would have expected to generate moderate margin improvement in 2023 without an NHP supply impact. But given this meaningful headwind, we expect the 2023 operating margin to be flat to down 150 basis points depending on the timing of the resumption of Cambodia NHP shipment.

對於營業利潤率，我們原本預計在 2023 年利潤率會適度改善，而不會受到 NHP 供應的影響。但鑑於這種重大逆風，我們預計 2023 年營業利潤率將持平或下降 150 個基點，具體取決於恢復柬埔寨 NHP 發貨的時間。

Longer term, we still believe there is operating margin improvement that is inherent in our business from a combination of leverage from higher volume, pricing and continuing to drive efficiency. We will not provide free cash flow or capital expenditure outlooks at this time because these metrics could vary based on the level of NHP supply impact that is incurred.

從長遠來看，我們仍然相信，由於銷量增加、定價和持續提高效率的槓桿作用相結合，我們的業務固有的營業利潤率有所提高。我們目前不會提供自由現金流或資本支出前景，因為這些指標可能會根據所產生的 NHP 供應影響程度而有所不同。

For 2022, free cash flow totaled $330.3 million compared to $532 million for the prior year. The decrease was due to higher CapEx as we added capacity to accommodate the robust demand as well as unfavorable working capital movements, the timing of which contributed to our free cash flow being below our prior outlook.

2022 年，自由現金流總計 3.303 億美元，上年為 5.32 億美元。減少的原因是資本支出增加，因為我們增加了能力以滿足強勁的需求以及不利的營運資金流動，這導致我們的自由現金流低於我們之前的預期。

Capital expenditures for 2022 increased by $96 million to $324.7 million with most of the increase driven by the continued capacity needs of the Safety Assessment business. Given the current NHP supply situation, we will reassess our capital needs for this year. Longer term, the targeted level for CapEx remains at approximately 9% of revenue as we expect to continue to invest in capacity in order to keep pace with a sustained underlying demand environment and support our long-term growth forecast.

2022 年的資本支出增加了 9600 萬美元，達到 3.247 億美元，其中大部分增長是由安全評估業務的持續能力需求推動的。鑑於目前的 NHP 供應情況，我們將重新評估今年的資金需求。從長遠來看，資本支出的目標水平仍保持在收入的 9% 左右，因為我們預計將繼續投資於產能，以跟上持續的潛在需求環境並支持我們的長期增長預測。

The next slide shows a summary of our 2023 financial guidance. Looking at the first quarter of 2023, we expect that year-over-year revenue growth will be in the high single-digit range on a reported basis and at or above the 10% level on an organic basis.

下一張幻燈片顯示了我們 2023 年財務指南的摘要。展望 2023 年第一季度，我們預計收入同比增長將在報告基礎上處於高個位數範圍內，並在有機基礎上達到或超過 10% 的水平。

We're expecting stronger revenue growth in the first half of 2023, both due to the comparisons to last year when growth accelerated throughout the year as well as the gating of the NHP supply impact. We expect only a small impact related to NHP supply in the first quarter because these large models are already in place to start the scheduled study.

我們預計 2023 年上半年的收入增長會更強勁，這既是因為與去年全年增長加速相比，也是因為 NHP 供應影響的門控。我們預計第一季度與 NHP 供應相關的影響很小，因為這些大型模型已經到位，可以開始預定的研究。

We expect earnings per share will decline at a mid-single-digit rate in the first quarter compared to $2.75 in the first quarter of last year. In addition to the impact of the Avian divestiture, the nonoperating headwinds will have a greater impact to earnings per share in the first quarter, specifically higher tax rate and increased interest expense.

我們預計第一季度每股收益將以中個位數的速度下降，而去年第一季度為 2.75 美元。除了 Avian 資產剝離的影響外，非經營不利因素將對第一季度的每股收益產生更大的影響，特別是更高的稅率和增加的利息支出。

As previously mentioned, the tax benefit from stock compensation is expected to be lower in 2023 with the greatest impact in the first quarter. We also will now have anniversary last year's Federal Reserve more aggressive interest rate increases in the first quarter. These 2 items are expected to result in a combined earnings headwind of approximately $0.40 per share.

如前所述，預計 2023 年股票薪酬帶來的稅收優惠將減少，第一季度的影響最大。我們現在也將迎來去年美聯儲在第一季度更積極加息的周年紀念日。這兩項預計將導致每股收益約 0.40 美元的合併收益逆風。

In addition, the Manufacturing segment faces a difficult comparison versus the first quarter of last year with regards to commercial readiness milestones in the CDMO business and Covid testing revenue in the Biologics Testing business. This will result in a lower growth rate for the Manufacturing segment in the first quarter. Each of these headwinds will improve throughout the year, beginning in the second quarter.

此外，在 CDMO 業務的商業準備里程碑和生物製品測試業務的 Covid 測試收入方面，製造部門與去年第一季度相比面臨困難。這將導致第一季度製造業部門的增長率下降。從第二季度開始，這些不利因素中的每一個都將在全年得到改善。

In conclusion, we're very pleased with our 2022 financial performance, and we'll proactively manage the challenges in 2023. We're confident in our ability to generate value for our shareholders by consistently growing revenue, earnings and cash flow.

總之，我們對 2022 年的財務業績感到非常滿意，我們將積極應對 2023 年的挑戰。我們有信心通過不斷增長的收入、收益和現金流為股東創造價值。

Over the last 5 years, we have achieved compound annual growth of 16% for revenue and 17% for earnings per share, generating robust operating and free cash flow while continuing to make necessary investments to support the growth of our business. We're focused on continuing to drive growth, executing our strategy and enhancing our position as the leading global nonclinical drug development partner, working with our clients from discovery and preclinical development through the safe manufacture of their life-saving therapies. Thank you.

在過去 5 年中，我們實現了 16% 的收入複合年增長率和 17% 的每股收益複合年增長率，產生了強勁的運營和自由現金流，同時繼續進行必要的投資以支持我們的業務增長。我們專注於繼續推動增長，執行我們的戰略並加強我們作為全球領先的非臨床藥物開發合作夥伴的地位，與我們的客戶合作，從發現和臨床前開發到安全製造他們的救生療法。謝謝。

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

我們的評論到此結束。我們現在將回答您的問題。

(Operator Instructions) And our first question will come from Derik De Bruin with Bank of America.

（操作員說明）我們的第一個問題將來自美國銀行的 Derik De Bruin。

Jim, I'm just curious, what are your customers doing that -- in the biotech space and elsewhere to -- in terms of their studies? I mean, is -- are other vendors having similar delays with similar issues? Basically, are you at risk of losing business because other vendors have better access to some of the model systems?

吉姆，我很好奇，你的客戶在生物技術領域和其他地方的研究中做了什麼？我的意思是，其他供應商是否因類似問題而出現類似延遲？基本上，您是否有失去業務的風險，因為其他供應商可以更好地訪問某些模型系統？

Tough to comment on the competition, Derik. I guess my overarching comment would be, number one, we are a much larger scale. Number two, we have different supply sources and different capabilities. But I would say that with regard to Cambodia, where 60% of the animals come from, we are all at least temporarily foreclosed from bringing new animals in and utilizing them on studies in the United States.

很難對比賽發表評論，德里克。我想我的首要評論是，第一，我們的規模要大得多。第二，我們有不同的供應來源和不同的能力。但我要說的是，關於 60% 的動物來自柬埔寨，我們至少暫時無法將新動物帶入美國並在美國進行研究。

So you want to extrapolate this and say this is an industry issue, a relatively profound one because drugs aren't going to move through preclinical and into the clinic. Biologics are not going to move unless they're tested on large animals, and it's going to has to be NHP. So we are -- our focus now is to work with fish and wildlife to come up with a collaborative methodology that they're in agreement with, and we can execute to show parentage, which is sort of the underlying issue here. It's going to be some sort of laboratory assay that we're developing, but we have to be able to do that quickly and across a large population of animals.

所以你想推斷這是一個行業問題，一個相對深刻的問題，因為藥物不會通過臨床前階段進入臨床階段。除非在大型動物身上進行測試，否則生物製劑不會移動，而且必須是 NHP。所以我們 - 我們現在的重點是與魚類和野生動物合作，提出一種他們同意的合作方法，我們可以執行以顯示出身，這是這裡的潛在問題。這將是我們正在開發的某種實驗室檢測方法，但我們必須能夠在大量動物中快速進行。

The -- just to reset the table for you, the irony is that demand is really significant for us. I can't comment on the competition, but I assume similarly. So demand is exceptional. We're well staffed. Capacity's in a good place. We actually have enough animal supply in terms of our relationships with the various suppliers that we have where we either own a piece or have a long-term contract. And we've hit this unanticipated speed bump with fish and wildlife. They're saying that they're concerned about parentage.

-- 只是為了給你重新安排一下，具有諷刺意味的是，需求對我們來說真的很重要。我不能對比賽發表評論，但我也有類似的看法。所以需求是異常的。我們人員配備齊全。容量在一個好地方。就我們與我們擁有的各種供應商的關係而言，我們實際上有足夠的動物供應，我們擁有一塊或有長期合同。我們遇到了魚類和野生動物帶來的意想不到的減速帶。他們說他們擔心親子關係。

So I don't -- I can't guarantee anything. I don't think this is a situation that we've been concerned about losing share. It's a situation of how do we -- we, and that's both Charles River and the competition to some extent, move past this so we can support the clients to get drugs through preclinical and to patients.

所以我不——我不能保證任何事情。我不認為這是我們一直擔心失去份額的情況。這是我們如何——我們，在某種程度上是查爾斯河和競爭對手，超越這一點，這樣我們就可以支持客戶通過臨床前和患者獲得藥物。

And that's -- that'll be pretty much 100% of our focus going forward. We're optimistic that we will be able -- that's been a request. We're optimistic that we'll be able to meet that request. It's a little bit difficult to determine exactly when it will be resolved and exactly when we will get the animals into the U.S.

那就是——這將是我們未來 100% 的重點。我們樂觀地認為我們能夠——這是一個請求。我們對能夠滿足該要求感到樂觀。確切地確定何時解決以及我們何時將動物帶入美國有點困難。

We've sized our guide, as we said in the prepared remarks, to either have animals kind of late in the third quarter for utilization in Q4. That would be sort of the best case. Worst case would be that Cambodia doesn't open up at all for fiscal '23. And of course, it's about 60% of the supply source, both for Charles River and the industry at large.

正如我們在準備好的評論中所說，我們已經調整了指南的大小，以便在第三季度末使用動物，以便在第四季度使用。那將是最好的情況。最壞的情況是柬埔寨在 23 財年根本不開放。當然，它約佔 Charles River 和整個行業供應來源的 60%。

So it's -- I don't know how else to say this. It's not really optional that we fix it -- have to fix it for our clients and for patients and for ourselves. I think the U.S. government authorities understand the criticality of the work that we do and the role that NHPs play. And we're hoping they'll work closely with us as we work through the resolution.

所以它——我不知道還能怎麼說。我們修復它並不是真正可選的——必須為我們的客戶、患者和我們自己修復它。我認為美國政府當局了解我們所做工作的重要性以及 NHP 發揮的作用。我們希望他們在我們通過決議的過程中與我們密切合作。

Great. And that was sort of my next follow-up on this one is like how closely are FDA and Fish and Wildlife working together? I mean, do they clearly understand the importance of what this is? And is there -- did you get any sort of suggest an all-in timing on when this would be resolved or what the milestone we need to see?

偉大的。那是我對這件事的下一個跟進，就像 FDA 和 Fish and Wildlife 的合作有多緊密？我的意思是，他們清楚地了解這是什麼的重要性嗎？有沒有——你有沒有得到任何關於何時解決這個問題或我們需要看到什麼里程碑的建議？

I mean, the timing is hard only because they're pretty much insistent that we prove parentage. By the same token, Fish and Wildlife absolutely understand how these animals are used and the critical nature of them. I know that various government agencies have been in conversation with one another on the outlook of the world through a different lens. But it's going to be essential to move drug development forward for hundreds of clients and drugs that we have a resolution.

我的意思是，時機很艱難，只是因為他們非常堅持要證明我們的親子關係。出於同樣的原因，Fish and Wildlife 絕對了解這些動物是如何被使用的，以及它們的關鍵性質。我知道各個政府機構一直在通過不同的視角就世界觀進行對話。但是，對於我們有解決方案的數百名客戶和藥物來說，推動藥物開發至關重要。

So we're off working on that. We're off with an open dialogue with Fish and Wildlife about what exactly they need, and we have to explain to them that the reality of. It's going to take some time to get this up and running, but we're well intentioned that we have deep science on our own. We'll collaborate with some others to get this up and running. And we'll provide these tests, which -- yes, that's the basis of this whole situation to prevent wild animals being used in biomedical research.

所以我們正在努力。我們將與魚類和野生動物展開公開對話，了解他們到底需要什麼，我們必須向他們解釋現實。啟動和運行它需要一些時間，但我們有良好的意願，我們自己擁有深入的科學。我們將與其他一些人合作來啟動和運行它。我們將提供這些測試——是的，這是整個情況的基礎，以防止野生動物被用於生物醫學研究。

Our next question will come from Eric Coldwell with Baird.

我們的下一個問題將來自 Baird 的 Eric Coldwell。

On the subpoena, are there any additional details you can provide on the timing of the receipt, what DOJ perhaps might think they have come across that would drive this?

關於傳票，您是否可以提供有關收到時間的任何其他詳細信息，司法部可能認為他們遇到了什麼會導致這種情況發生？

And then can you confirm that the incremental margin on the rough $80 million to $160 million revenue headwind is about 50% to 60%? That's what's embedded in the guidance.

然後你能確認 8000 萬到 1.6 億美元收入逆風的增量利潤率大約是 50% 到 60% 嗎？這就是指南中嵌入的內容。

And then third, could you talk about the supply expansion you've -- to what extent you've been able to achieve supply expansion beyond Cambodia? Is there any additional detail you would be willing to provide on countries of origin, new suppliers, increases with existing non-Cambodian suppliers? Is there anything you can share to let us know what might be the ultimate outcome if, let's say, worst-case scenario Cambodia doesn't reopen?

第三，你能談談你的供應擴張嗎——你在多大程度上能夠實現柬埔寨以外的供應擴張？關於原產國、新供應商、現有非柬埔寨供應商的增加，您是否願意提供任何額外的細節？您有什麼可以分享的，讓我們知道如果最壞的情況是柬埔寨不重新開放，最終結果可能是什麼？

Sure. Subpoena is relatively recent, Eric. And we're a subject here, meaning that they want to get information from us. Just to back up, you know that another Cambodian supplier was indicted in November, and that's not somebody that we work with. And so we took a couple of our competitors to work with, and that started the whole questioning and to prove through the methodology. And so they are now looking at all of the suppliers in Cambodia, one of whom we get our monkeys from.

當然。傳票是相對較新的，埃里克。我們是這裡的主題，這意味著他們想從我們這裡獲取信息。只是作為備份，你知道另一家柬埔寨供應商在 11 月被起訴，那不是我們合作的人。所以我們找了幾個競爭對手一起工作，這就開始了整個質疑並通過方法論來證明。因此，他們現在正在尋找柬埔寨的所有供應商，我們從其中一家獲得猴子。

We were just there and audited that, I guess, I should say, without sort of weighing in on what the government thinks. So it doesn't think that, we believe it's a professionally run operation from a veterinary point of view, from a nutritional point of view, from a housing point of view, from a shipment point of view.

我們只是在那裡進行了審計，我想，我應該說，沒有考慮政府的想法。所以它不認為，我們認為從獸醫的角度、從營養的角度、從住房的角度、從裝運的角度來看，這是一個專業運行的操作。

And it's a big farm. And they take our advice and counsel really well. So we feel that we have some end point and some auditing capability with them. We believe that as this DOJ investigation continues, we're confident that they'll conclude that any concerns they have with regard to Charles River are without merit.

這是一個大農場。他們非常接受我們的建議和忠告。所以我們覺得我們有一些終點和一些審計能力。我們相信，隨著 DOJ 調查的繼續，我們相信他們會得出結論，他們對 Charles River 的任何擔憂都是毫無根據的。

We don't believe we did anything wrong. To the contrary, we always fully complied with U.S. and international laws. So we'll work closely with them. We'll be collaborative. We'll be transparent. We will take the high road in terms of coming up with a solution that works for them, works for us and probably will work for other providers and competition, which is great.

我們不相信我們做錯了什麼。相反，我們始終完全遵守美國和國際法律。因此，我們將與他們密切合作。我們會合作的。我們會透明的。我們將在提出對他們、對我們有用並且可能對其他供應商和競爭對手有用的解決方案方面走高路，這很棒。

The supply thing is -- I mean, it is what it is, Eric. It's frustrating. We worked really hard over the last, I'd say, COVID years, so probably 3 years now, maybe 4, particularly after China closed out in 2018 to have a multiplicity of suppliers. And I won't go through where they are and what their names are, but we have multiple supply sources.

供應的事情是 - 我的意思是，它就是這樣，埃里克。真令人沮喪。我們在過去的幾年裡非常努力，我想說，COVID 年，所以現在可能是 3 年，也許是 4 年，特別是在中國於 2018 年關閉以擁有多個供應商之後。我不會詳細說明他們在哪里以及他們的名字是什麼，但我們有多個供應來源。

And so we were starting this year with more than a sufficient number of monkeys to do the work. You know we have orders last year way into the back half of '23 and some into '24 and hopefully, some incremental on top of that. And as I said earlier, we had staff and space.

因此，我們從今年開始就擁有足夠數量的猴子來完成這項工作。你知道我們去年的訂單一直持續到 23 年的後半段，一些進入 24 年，希望在此基礎上增加一些。正如我之前所說，我們有員工和空間。

So we're heading into this and we had an extraordinary second half of last year. So we've been heading into this year really optimistic about our supply sources. So I would say that we have multiple supply sources, which is great.

所以我們正在進入這個領域，去年下半年我們表現不平。因此，我們一直對今年的供應來源非常樂觀。所以我想說我們有多個供應來源，這很好。

I would tell you and then specific answer to your question that if Cambodia never opens up, there will be an insufficient number of monkeys to do the work for the whole industry. And I'm not just saying this with -- through Charles River lens. That's not a tolerable situation. That's not an acceptable situation for the health of patients, for drug development, for getting drugs through preclinical into the clinic.

我會告訴你，然後具體回答你的問題，如果柬埔寨永遠不開放，那麼猴子的數量將不足以為整個行業做這項工作。我不只是通過查爾斯河的鏡頭來這麼說。那不是一個可以容忍的情況。對於患者的健康、藥物開發以及將藥物通過臨床前階段進入臨床來說，這都是不可接受的情況。

So we have to find an accommodation. They -- the dialogue with them is quite open, and they've been really clear to say you just have to show parentage and by that for anybody who is listening who doesn't know, what we mean by that is just that you can track the offspring to mothers and that those mothers are part of a purpose-bred operation.

所以我們得找個住處。他們 - 與他們的對話非常開放，他們非常清楚地說你只需要證明出身，對於任何不知道的人來說，我們的意思是你可以追踪後代到母親，而這些母親是專門培育的行動的一部分。

So we believe that we can do that. We believe that Cambodia will open up at some point. We're hopeful that it will be -- sort of our best case would be kind of end-ish of third quarter with the animals in the fourth because it's a big industry dilemma if that can't happen. And I will let Flavia drill down on the financial impact of what we just gave in our guidance.

所以我們相信我們可以做到。我們相信柬埔寨會在某個時候開放。我們希望它會是——我們最好的情況是第三季度結束，第四季度的動物，因為如果這不能發生，這將是一個巨大的行業困境。我會讓 Flavia 深入了解我們剛剛在指南中給出的財務影響。

Thanks, Jim. Eric, yes, our EPS guidance obviously assumes different scenarios as we mentioned in our prepared remarks. Obviously, the revenue loss drops down at a fairly high rate initially. But I'll prefer not to comment on the specifics.

謝謝，吉姆。埃里克，是的，我們的 EPS 指南顯然假設了我們在準備好的評論中提到的不同場景。顯然，收入損失最初以相當高的速度下降。但我不想對細節發表評論。

Our next question will come from Sandy Draper with Guggenheim.

我們的下一個問題將來自古根海姆的桑迪德雷珀。

Sandy, are you on mute? We can't hear you.

桑迪，你靜音了嗎？我們聽不到你的聲音。

Yes. So just a quick follow-up on NHP and then my bigger question is on the CDMO business. But to make sure I understand it correctly, you've decided, Jim, to stop. But were you ordered to stop taking on primates from the supplier who is resolved and basically is this -- you're waiting from signals from the Food and Wildlife or the FDA and so your hands are tied? Or once you think things are clear, you can make the call? So I just want to make sure I understand that.

是的。所以只是對 NHP 的快速跟進，然後我更大的問題是關於 CDMO 業務。但是為了確保我理解正確，吉姆，你決定停下來。但是你是否被命令停止從已經解決的供應商那裡接收靈長類動物，基本上是這樣 - 你正在等待來自食品和野生動物或 FDA 的信號，所以你的手被束縛了？或者一旦你認為事情已經清楚了，你就可以打電話了？所以我只想確保我理解這一點。

And then the bigger question is just on clearly encouraging signs on the CDMO in your guidance. Going back to the miss in '22, is this just a function of time and that you've sort of gone through that 12 months of just rebuilding the pipeline that you had that sort of the air pocket? Or has demand actually gotten better?

然後更大的問題只是在您的指導中明確鼓勵 CDMO 的跡象。回到 22 年的失誤，這是否只是時間的函數，你已經經歷了 12 個月的時間來重建你有那種氣穴的管道？還是需求實際上變得更好了？

Yes. So on the Fish and Wildlife situation, so there was all sorts of contradictory and probably erroneous information about what Cambodia was doing after this first farm was indicted back in November. So the initial rumor was that the Cambodian government just closed down exports, which was -- we don't believe was ever true.

是的。因此，在魚類和野生動物的情況下，在 11 月第一個農場被起訴後，關於柬埔寨正在做什麼的各種相互矛盾的信息可能是錯誤的。所以最初的謠言是柬埔寨政府剛剛關閉了出口，我們不相信這是真的。

So Cambodia is -- from their end, is open for business. We'd like to shift the animals, we'll provide the paperwork. The U.S. government is saying, you can't bring them in yet. And the ones that you have in country, and we have some in country, you can't use yet until we sort of work out and ensure that they are indeed purpose-bred.

所以柬埔寨 - 從他們的角度來看，是開放的。我們想轉移動物，我們會提供文件。美國政府說，你還不能把他們帶進來。你在國內有的，我們在國內也有一些，在我們解決問題並確保它們確實是專門培育的之前，你還不能使用。

So no. So I don't think it's -- I don't think we can just do what we want. I mean, there's always permitting. There are these (inaudible) permits that one has to get and then they -- when those are canceled, you can go ahead and utilize the animal.

所以不行。所以我不認為這是 - 我不認為我們可以做我們想做的事。我的意思是，總是允許的。人們必須獲得這些（聽不清的）許可證，然後他們——當這些許可證被取消時，你可以繼續使用動物。

So just it's your problem, I guess our hands are tied, but we're trying to look at that positively that it's within our control to get them untied. They're just going to sort of wait for us to make a proposal on how we can prove that they were purpose-bred.

所以這是你的問題，我想我們的手被束縛了，但我們正試圖積極地看待這一點，讓他們解開束縛在我們的控制範圍內。他們只是在等待我們就如何證明他們是專門培育的提出建議。

So as I said, that's like 100% of our focus right now in our control. And obviously, the faster we do it, the faster they will allow us to utilize the animals.

所以正如我所說，這就像我們現在 100% 的注意力在我們的控制之中。顯然，我們做得越快，他們就能越快地讓我們利用這些動物。

CDMO business is an interesting one. As we've spoken to consistently for a while, now integration has been complicated. The science is quite complicated and new. And we really had to restaff all 3 of the companies, the major companies that we bought from kind of top to bottom, senior management, sales, regulatory, et cetera.

CDMO 業務是一個有趣的業務。正如我們一直以來所說的那樣，現在集成變得複雜了。這門科學相當複雜和新穎。我們真的不得不重新安排所有 3 家公司的人員，我們從上到下收購的主要公司，高級管理人員、銷售人員、監管人員等。

I think the demand has been great across the board. The sales cycle is long. So I'm not sure that was totally clear to us or the length wasn't crystal clear to us when we bought the company and plus some of the clients that we felt we had firm commitments weren't so firm. So I think we've done a great job with the new sales force where people that understand the science can explain it well.

我認為整體需求都很大。銷售週期長。所以我不確定這對我們來說是否完全清楚，或者當我們購買公司時我們並不清楚長度，加上我們認為我們有堅定承諾的一些客戶並不那麼堅定。所以我認為我們在新的銷售隊伍方面做得很好，了解科學的人可以很好地解釋它。

And we have in our prepared remarks a commentary $100 million of new business come in last year. Our Memphis facility, which is a gene-modified cell therapy manufacturing operation. This sounds particularly solid right now just in terms of numbers of clients, scale of clients. By that, I mean, there's a bunch of companies that are -- cell therapy companies that are kind of small and new that you've never heard of, but there's a bunch of really big companies, including big biotech and big pharma who either don't have their own space or don't feel there's sufficient space in the system. We have several clients that we're talking to who have either finished Phase III or almost -- who are talking to us about commercial quantities.

在我們準備好的評論中，去年有 1 億美元的新業務。我們的孟菲斯工廠是一家基因修飾細胞療法製造企業。就客戶數量和客戶規模而言，這聽起來特別可靠。就此而言，我的意思是，有很多公司——細胞治療公司，它們是一些你從未聽說過的小而新的公司，但也有一些非常大的公司，包括大型生物技術公司和大型製藥公司，它們要么沒有自己的空間，或者覺得系統中沒有足夠的空間。我們有幾個客戶正在與他們交談，他們要么已經完成了 III 期，要么幾乎完成了——他們正在與我們談論商業數量。

And there's at least one client that we are confident that we will produce commercial quantities for them this fiscal year, which obviously would be fabulous just in terms of, I don't know, expertise, reputation, capability and really doing it because there's still a few commercial products actually being manufactured.

至少有一個客戶，我們有信心我們將在本財年為他們生產商業數量的產品，這顯然就我不知道的專業知識、聲譽、能力和真正做到這一點而言是非常棒的，因為還有一些實際正在製造的商業產品。

So the business feels better, stronger, better demand, better client understanding of who we are, better integration amongst and between the cell and gene therapy companies and also between cell and gene therapy and our biologics business, in particular, and I would say safety.

因此，業務感覺更好、更強、更好的需求、更好的客戶了解我們是誰、細胞和基因治療公司之間以及細胞和基因治療與我們的生物製劑業務之間的更好整合，特別是，我會說安全.

Secondarily, we have very good facilities that have been all 3 of the big -- 3 of the major facilities have been added on to over the past year. So we've got new space, incremental space and pretty well staffed. It's a very attractive area. There's lots of people that want to work and sell in gene therapy. And I think there's a little bit of a positive buzz around our capability and potential. So we should have nice growth rates in those businesses in fiscal '23.

其次，我們擁有非常好的設施，在過去的一年中，所有 3 個大型設施中的 3 個都已添加。所以我們有新的空間，增量空間和相當好的人員。這是一個非常有吸引力的地區。有很多人想在基因治療領域工作和銷售。而且我認為圍繞我們的能力和潛力有一些積極的討論。因此，我們應該在 23 財年的這些業務中取得不錯的增長率。

The margins won't be anywhere near. We want them to be, but they will be distinctly better than the prior year. So CDMO should be accretive for sort of the manufacturing top and bottom line. And similarly, obviously, to a lesser extent given the denominator, but similarly to CRL's top and bottom line also. So we feel good about those businesses as we've entered this fiscal year.

利潤率不會接近。我們希望他們成為，但他們會明顯好於前一年。因此，CDMO 應該在某種程度上增加製造的頂線和底線。同樣，顯然，給定分母的程度較小，但也類似於 CRL 的頂線和底線。因此，在我們進入本財年之際，我們對這些業務感覺良好。

Our next question will come from Elizabeth Anderson with Evercore.

我們的下一個問題將來自 Evercore 的 Elizabeth Anderson。

I was wondering if you could comment, it seems like you -- based on the guidance that you gave for the full year on NHPs that you probably have enough supply domestically to get you to this sort of fourth quarter, at least between the Cambodia and non-Cambodian supply. So if that's something you could comment on.

我想知道你是否可以發表評論，看起來你——根據你對 NHP 的全年指導，你可能有足夠的國內供應讓你進入第四季度，至少在柬埔寨和柬埔寨之間。非柬埔寨貨源。所以如果這是你可以評論的事情。

And then secondarily, can you talk about the impact of potentially follow-on work after NHPs? It seems like maybe is that something that you guys have accounted for in the guidance? Or is that something that would maybe impact 2024 more than 2023?

其次，您能否談談 NHP 之後可能進行的後續工作的影響？似乎你們在指南中已經說明了什麼？或者這對 2024 年的影響可能超過 2023 年？

Yes. So we have some supply, for sure, Elizabeth. So we have -- we do a lot of NHP work in the U.S., but we also do -- I mentioned Europe that we have other suppliers for European operations. We have other suppliers for the U.S. We had monkeys in countries, some of which our hands are tied at the moment, but some of which our hands aren't tied.

是的。所以我們肯定有一些供應，伊麗莎白。所以我們有——我們在美國做了很多 NHP 工作，但我們也有——我提到歐洲，我們有其他供應商用於歐洲業務。我們有美國的其他供應商。我們在一些國家有猴子，其中一些目前我們的手被束縛，但有些我們的手沒有被束縛。

And I don't want to peel it back too finely, but I think that we have a sufficient supply for a while, and then it begins to wind a little bit. We're just going to have to have conversations with our clients about their priorities and what they really need to be done quickly and try to match their priorities and the cadence of their drug development pipelines with availability of space and NHPs.

而且我不想把它剝得太細，但我認為我們有足夠的供應一段時間，然後它開始有點纏繞。我們只需要與我們的客戶就他們的優先事項以及他們真正需要快速完成的事情進行對話，並嘗試將他們的優先事項和藥物開發管道的節奏與空間和 NHP 的可用性相匹配。

So yes, to some extent, we'll have sufficient supply. And to some extent, we won't. And hopefully, as we've indicated in our prepared remarks today and in the numbers in our guidance that we'll be off and running in the back half of the year.

所以是的，在某種程度上，我們會有足夠的供應。在某種程度上，我們不會。希望，正如我們在今天準備好的評論和我們的指導數字中所指出的那樣，我們將在今年下半年開始運行。

We're continuing to take orders and book orders certainly into 2024. I don't want to comment on what the impact is in '24. We're early in the first quarter of '23 except to say that our hope would be to resolve this problem because we have sufficient supply if the U.S. Fish and Wildlife Service and the other regulatory agencies will let us use them so.

我們將在 2024 年繼續接受訂單和預訂訂單。我不想評論 24 年的影響。我們在 23 年第一季度早些時候只是說我們希望解決這個問題，因為如果美國魚類和野生動物服務局和其他監管機構允許我們使用它們，我們就有足夠的供應。

And just given the importance of the work, we have to figure it out. We're confident that they will listen. They understand the importance. We're also confident they don't have a lot of options. Very few of our clients have internal toxicology capacity. And even if they did, they can't get the NHPs either.

鑑於這項工作的重要性，我們必須弄清楚。我們相信他們會傾聽。他們明白重要性。我們也相信他們沒有太多選擇。我們的客戶中很少有內部毒理學能力。即使他們這樣做了，他們也無法獲得 NHP。

And we have perfectly capable competitors, but they have limited infrastructures, and they have limited access to NHPs as well. So just given our scale and prominence, we have to resolve it. And we're hopeful that people will work with us and understand that we're doing everything in good faith and want to come up with a scientific solution that satisfies everybody's expectations and demands.

我們擁有完全有能力的競爭對手，但他們的基礎設施有限，而且他們對 NHP 的訪問也有限。因此，鑑於我們的規模和知名度，我們必須解決它。我們希望人們能與我們合作，並理解我們所做的一切都是真誠的，並希望提出一個科學的解決方案來滿足每個人的期望和要求。

Our next question will come from Jacob Johnson with Stephens.

我們的下一個問題將來自 Jacob Johnson 和 Stephens。

This is [Mac] on for Jacob. Just a quick one for me. Are there any areas of your business where the funding environment actually drives additional demand or outsourcing? I think CRADL is perhaps one of these areas?

這是 Jacob 的 [Mac]。對我來說只是一個快速的。在您的業務領域中，資金環境是否實際推動了額外需求或外包？我認為 CRADL 可能是這些領域之一？

Yes. CRADL for sure. CRADL's -- I don't want to overstate it. I'd say it's a relatively recession-proof business and kind of the pure-play outsourcing move for -- we thought it was only going to be small companies. It's a whole range of companies.

是的。當然是 CRADL。 CRADL 的——我不想誇大它。我會說這是一個相對抗衰退的業務和一種純粹的外包舉措——我們認為它只會是小公司。這是各種各樣的公司。

It's quite interesting, but for everyone at the moment who might not want to add -- build de novo space, add on to the current space, just hold on to the capital and at least small amounts of space from us, use our people either in large measure or a small measure. I think that business is going really well.

這很有趣，但對於目前可能不想添加的每個人來說——重新構建空間，添加到當前空間，只保留資本和至少我們的少量空間，或者使用我們的人員在很大程度上或小的措施。我認為業務進展非常順利。

Look, our whole thesis -- I mean the whole basis of the bargain with Charles River is that we can be your outsourcing partner. You use our people and our space as if they're your own. We'll invest in technology and capacity consistently. We'll help you get your drug into the market or at least tell you that it shouldn't get into the market because of high levels of toxicity or whatever, lack of efficacy.

看，我們的整個論點——我的意思是與 Charles River 討價還價的全部基礎是我們可以成為您的外包合作夥伴。您可以像使用自己的人員和空間一樣使用我們的人員和空間。我們將持續投資於技術和產能。我們會幫助您將您的藥物推向市場，或者至少告訴您它不應該因為高毒性或其他原因而進入市場，缺乏療效。

So I think that so much of what we do, all of the Research Model Services are pure outsourcing. All of our Discovery and Safety work is pure outsourcing. And so is the Biologics work. And so -- and everything that we've added through M&A over the last decade or even 2 decades has been about providing a large cohesive portfolio to -- so somebody can literally give us a drug and say, please tell me, (inaudible) and get this thing to market?

所以我認為我們所做的很多事情，所有的研究模型服務都是純粹的外包。我們所有的發現和安全工作都是純粹的外包。生物製品的工作也是如此。因此 - 我們在過去十年甚至 20 年通過併購增加的一切都是關於提供一個龐大的有凝聚力的投資組合 - 所以有人可以給我們一種藥物並說，請告訴我，（聽不清）把這個東西推向市場？

So obviously, it's somewhat correlated to the availability of cash. I would say that our biotech clients, in particular, are very judicious and thoughtful about the way they spend money. So -- though they tend not to move forward unless they think they have enough money to at least get their drug minimally into the clinic and actually to proof of concept.

很明顯，它與現金的可用性有些相關。我要說的是，我們的生物技術客戶尤其對他們的花錢方式非常明智和深思熟慮。所以 - 儘管他們往往不會向前推進，除非他們認為他們有足夠的錢至少可以將他們的藥物最低限度地投入臨床並實際證明概念。

And we're still hearing very little from our clients about concern about access to capital and how that would impair or slow down both the demands from us and ability to spend. So we think our -- and if they have those concerns, and they're just not articulating it, I think our portfolio is quite helpful for them. And yes, I would agree that CRADL is kind of the top of the list.

我們仍然很少從客戶那裡聽到他們對獲得資本的擔憂，以及這將如何損害或減緩我們的需求和支出能力。所以我們認為我們的——如果他們有這些擔憂，而他們只是沒有表達出來，我認為我們的投資組合對他們很有幫助。是的，我同意 CRADL 名列榜首。

Our next question will come from Patrick Donnelly with Citi.

我們的下一個問題將來自花旗的 Patrick Donnelly。

Jim, can you maybe just talk through the timeline of how this all played out? I mean, obviously, you put out the 8-K, I think it was mid to late this November, sorry. And then December, there were mixed reports. Cambodia was shut down, then it wasn't a few days later. And obviously, you guys got the subpoena just a few days ago.

吉姆，你能不能通過時間表談談這一切是如何發生的？我的意思是，很明顯，你推出了 8-K，我想是在今年 11 月中下旬，抱歉。然後是 12 月，有好壞參半的報導。柬埔寨封城了，那不是幾天之後。顯然，你們幾天前才收到傳票。

So can you just talk about when you guys started to realize, hey, this might be a real disruption, and this is going to shut down and just trying to get a sense in terms of how quickly you could prepare for this and just how it played out internally would be helpful.

所以你能不能談談你們什麼時候開始意識到，嘿，這可能是一個真正的中斷，這將要關閉，只是想了解一下你們可以多快為此做好準備，以及它是如何準備的在內部播放會有所幫助。

Sure. When the information came public about the indictment in November of a supplier in Cambodia, that was the first time we know anything about -- any concern about Cambodia. Just to remind you all this -- probably around the same percentage of our animals, our NHPs were coming from China up until that point.

當然。當有關 11 月柬埔寨一家供應商被起訴的信息公開時，那是我們第一次知道有關柬埔寨的任何擔憂。提醒大家這一切——可能大約相同比例的我們的動物，我們的 NHPs 直到那時都來自中國。

We had pretty wide scale supply agreements from China, and then the Chinese government closed those exports down in favor of keeping those monkeys in country. And we and our competitors pivoted to Cambodia, which has essentially the same type of animals or the same genetic background. So we knew that the research community would be fine with them. They also didn't really have a choice. But it's similar background.

我們與中國簽訂了相當廣泛的供應協議，然後中國政府關閉了這些出口，以支持將這些猴子留在國內。我們和我們的競爭對手將重心轉向了柬埔寨，那裡擁有基本上相同類型的動物或相同的遺傳背景。所以我們知道研究界會接受他們。他們也沒有真正的選擇。但背景相似。

So we've been working hard to validate our supply sources by visiting them, by telling them what our kind of requirements were from an operational point of view. We've been quite pleased with them. We've been quite pleased with the quality of monkeys as I said earlier. We had probably the best -- not probably, we had the best year in the company's history for our Safety Assessment business in fiscal '22. Really strong demand way out 1 year or 1.5 years and escalating price points and market share gains.

因此，我們一直在努力通過訪問他們來驗證我們的供應來源，從運營的角度告訴他們我們的需求類型。我們對他們很滿意。正如我之前所說，我們對猴子的質量非常滿意。我們可能是最好的 - 可能不是，我們在 22 財年的安全評估業務中度過了公司歷史上最好的一年。真正強勁的需求將在 1 年或 1.5 年內結束，價格點和市場份額不斷增加。

And so we were feeling very good coming into this year as we were locking down our operating plan, and this came literally out of the blue. And then as you say, I can't put a finer point on it than what you said. All sorts of rumors -- tough to verify. But Cambodia closed, no it's not closed. Great, it's not closed, but then we got U.S. government is we don't care, but you can't use them until you can determine and prove to us that the animals are purpose-bred.

因此，進入今年以來，我們感覺非常好，因為我們正在鎖定我們的運營計劃，而這確實是出乎意料的。然後正如你所說，我不能說出比你所說的更好的觀點了。各種謠言——難以證實。但是柬埔寨關閉了，不，它沒有關閉。太好了，它沒有關閉，但後來我們得到了美國政府的意見，我們不在乎，但是在您可以確定並向我們證明這些動物是專門飼養的之前，您不能使用它們。

So it's just November to now, which is -- it feels like decades, that's a relatively short period of time. We have finally opened up channels to have conversations with both DOJ and Fish and Wildlife, obviously, not only will we cooperate, but I think it's incumbent upon us given our scale and who we are to be the leaders in solving this problem.

所以從 11 月到現在，感覺就像幾十年，那是一段相對較短的時間。我們終於打開了與 DOJ 和 Fish and Wildlife 進行對話的渠道，顯然，我們不僅會合作，而且考慮到我們的規模以及我們將成為解決這個問題的領導者，我認為我們有責任。

We have to solve this for the client base. By that, I mean, we have to come up with the necessary tests that can be done quickly to determine which animals -- that the animals are indeed purpose-bred, and we will do that.

我們必須為客戶群解決這個問題。我的意思是，我們必須想出可以快速完成的必要測試，以確定哪些動物——這些動物確實是專門培育的，我們會這樣做。

So we'll stay close to all of our suppliers or particularly the one that we -- the principal one that we use in Cambodia, provide advice and counsel on what we think they need to do additionally on their end. And we'll enhance our own internal testing methodology such that we can just show efficient wildlife data, and hopefully, they'll be pleased with it.

因此，我們將與我們所有的供應商保持密切聯繫，尤其是我們在柬埔寨使用的主要供應商，就我們認為他們需要額外做的事情提供建議和建議。我們將增強我們自己的內部測試方法，這樣我們就可以展示有效的野生動物數據，希望他們會對此感到滿意。

And it's as straightforward as frustrating and as sort of sudden as that, the -- it just literally sort of -- the information and the kind of severity of what the government was looking for seem to come out of nowhere, certainly with no advanced notice. And it's not something we've spoken to them about previously. And as I said, we had an extraordinary fiscal '22, so -- and never even a hint of this kind of concern or investigation or conversation.

它既直截了當又令人沮喪，而且有點突然，——從字面上看——政府正在尋找的信息和嚴重程度似乎是憑空而來的，當然沒有提前通知.這不是我們之前與他們談過的事情。正如我所說，我們有一個非凡的 22 財政年度，所以 - 甚至從來沒有暗示過這種擔憂或調查或對話。

Our next question will come from Max Smock with William Blair.

我們的下一個問題將來自 Max Smock 和 William Blair。

Maybe one for me on the CDMO business. You mentioned a stronger sales funnel for this part of the company. And just wondering if there's any more detail you can share around how the sales funnel has grown over the last couple of quarters here, and what you're seeing in terms of the strength in the cell and gene therapy market more broadly?

也許對我來說是關於 CDMO 業務的。你提到了公司這部分更強大的銷售渠道。只是想知道您是否可以分享更多關於過去幾個季度銷售漏斗如何增長的細節，以及您在更廣泛的細胞和基因治療市場的實力方面看到了什麼？

And then in terms of those potential opportunities that you've won so far, I guess, it would be helpful to hear really what has differentiated you or what you think differentiates you from some of your larger competitors in the space?

然後，就您迄今為止贏得的那些潛在機會而言，我想，聽到真正讓您與眾不同或您認為自己與該領域一些較大競爭對手的區別會很有幫助嗎？

Sure. The market is strong and has remained strong. There's a plethora of cell and gene therapy drugs that have been co-discovered and need to be developed either to success or failure.

當然。市場強勁並且一直保持強勁。有大量的細胞和基因治療藥物是共同發現的，需要開發才能成功或失敗。

So we're going to be very, very busy. We've, as I said earlier, retooled the sales organization. So we've got people with great expertise in both cell and gene therapy to understand both the science and the processes for manufacturing and the time frame. As I said earlier, the time frame is longer than we had anticipated.

所以我們會非常非常忙。正如我之前所說，我們已經重組了銷售組織。因此，我們擁有在細胞和基因治療方面具有豐富專業知識的人員，以了解製造的科學和過程以及時間框架。正如我之前所說，時間框架比我們預期的要長。

So we're really pleased with the way we've been signing up clients, large and small, the openness to share their anticipated plans with us to deal with the market size they think the drugs might have. As I said earlier, we have several clients that are on the verge of commercialization. It doesn't mean the drugs will get to market, but I'm just saying from a regulatory point of view are on the verge of having finished clinicals and will be filing and one that has moved into a commercial zone.

因此，我們對我們與大大小小的客戶簽約的方式以及與我們分享他們預期的計劃以應對他們認為這些藥物可能擁有的市場規模的開放態度感到非常滿意。正如我之前所說，我們有幾個客戶正處於商業化的邊緣。這並不意味著這些藥物將進入市場，但我只是說從監管的角度來看，它們即將完成臨床試驗並將提交申請，並且已經進入商業區。

So the sales funnel feels solid, consistent, persistent and pretty varied in terms of the scale of the companies. The market itself, the -- it's probably a number we should update, but we -- when we quantified it last time, we said they were about 3,000 cell and gene therapy drugs in development, probably 2/3 of which were in the preclinical domain. And obviously, some meaningful portion of these we'll get to work on.

因此，就公司規模而言，銷售漏斗感覺穩固、一致、持久且變化很大。市場本身——這可能是一個我們應該更新的數字，但是我們——當我們上次對其進行量化時，我們說他們正在開發大約 3,000 種細胞和基因治療藥物，其中可能有 2/3 處於臨床前階段領域。顯然，我們將著手處理其中一些有意義的部分。

The differentiating factor for us and the reason we went into CDMO space having kind of slid from years ago because it's kind of a crowded space is that this is kind of an interesting niche. We have a couple of other very good players in the space, which is fine. The market needs them, but the differentiating feature is that we don't just manufacture a drug. We have the Biologics Testing business, which is kind of how we ended up pivoting back into this space because clients were saying speed is of the essence. We give you our molecule and develop it for us. We can't tolerate you sending us out to find some of the manufacturer negotiating prices, maybe someone we don't know or trust. We'd like you to be able to do that for us.

對我們來說，差異化因素以及我們進入 CDMO 領域的原因從多年前開始有所下滑，因為這是一個擁擠的領域，這是一個有趣的利基市場。我們在這個領域還有其他一些非常優秀的玩家，這很好。市場需要它們，但與眾不同的是我們不只是製造藥物。我們有生物製品測試業務，這就是我們最終回到這個領域的方式，因為客戶說速度至關重要。我們為您提供我們的分子並為我們開發它。我們不能容忍您派我們去尋找一些談判價格的製造商，也許是我們不認識或不信任的人。我們希望您能夠為我們做到這一點。

So if you think about it, we can do some of the discovery development. We can do all the toxicology work to say it's safe, then we can test that molecule before it goes into the clinic -- sorry, we can now manufacture the molecule, and then test it before it goes into the clinic and then test it as it goes into commercialization.

所以如果你考慮一下，我們可以做一些發現開發。我們可以做所有的毒理學工作來證明它是安全的，然後我們可以在它進入臨床之前測試該分子——抱歉，我們現在可以製造該分子，然後在它進入臨床之前測試它，然後測試它作為它進入商業化。

So I do think it holds true not just for cell and gene therapy but pretty much everything we do. We just have this -- we have a broader portfolio than the competition. And even if they're bigger companies and even if they're bigger and have a larger reputation than us for being a CDMO, they don't have the pull-through that we have, and they don't have a comprehensive portfolio. We think that gives us a significant and distinct competitive advantage.

所以我確實認為它不僅適用於細胞和基因治療，而且適用於我們所做的幾乎所有事情。我們只有這個——我們擁有比競爭對手更廣泛的產品組合。即使他們是更大的公司，即使他們作為 CDMO 比我們更大並且享有更高的聲譽，他們也沒有我們所擁有的成功，他們也沒有全面的投資組合。我們認為這給了我們顯著且獨特的競爭優勢。

Our next question will come from Dan Leonard with Credit Suisse.

我們的下一個問題將來自瑞士信貸的 Dan Leonard。

I have a couple of follow-ups to Derik's question at the start on what customers are doing with the NHP supply constraints. How actively are they pivoting to different models like many pigs or dogs? And are clients being more discriminating about NHP use in line with the recent FDA guidance?

我對 Derik 一開始提出的關於客戶如何處理 NHP 供應限制的問題進行了一些跟進。他們有多積極地轉向不同的模型，比如許多豬或狗？客戶是否根據最近的 FDA 指南對 NHP 的使用更加歧視？

And then finally, is there any chance, Jim, that the heightened NHP concern reduces long-term demand for NHPs from biopharma as clients reconsider their NHP needs. And if that happens, what does that do to Charles River's business opportunity?

最後，吉姆，隨著客戶重新考慮他們的 NHP 需求，對 NHP 的高度關注是否有可能減少生物製藥對 NHP 的長期需求。如果發生這種情況，這對 Charles River 的商機有何影響？

Very smart and sophisticated question. Not an easy one to answer. I think that we all particularly given the complexity of NHP availability and by the way, it's always been complex. It's just more complex these days because of the sheer numbers.

非常聰明和復雜的問題。不是一件容易回答的事情。我認為我們都特別考慮到 NHP 可用性的複雜性，順便說一句，它一直很複雜。由於數量龐大，如今它變得更加複雜。

If there was an alternative species that was -- yes. Let's start with your pig question. You could produce them domestically, and they have litters as opposed to one offspring, and you could get significant numbers. The problem is -- and by the way, we do a fair amount of swine work right now, mostly for dermatology and cardiovascular work.

如果有一個替代物種——是的。讓我們從你的豬問題開始。你可以在國內生產它們，它們生的是窩而不是一個後代，而且你可以獲得大量數量。問題是——順便說一下，我們現在做了大量的豬工作，主要是皮膚病學和心血管工作。

But it's not a bad model. Several problems and several issues. Number one is there are not enough swine either. Number two is if you use sort of farm size swine, they're just too big. And by too big, I mean, at that stage, drug companies have made a very small amount of the drug, which costs extraordinary amount.

但這不是一個壞模型。幾個問題和幾個問題。第一，豬也不夠。第二，如果你使用某種農場大小的豬，它們就太大了。太大了，我的意思是，在那個階段，製藥公司生產的藥物數量非常少，但價格卻非常高。

So they'd like to put it in small animals. So if you put it in mice or rats, that's obviously a small amount of drug. And the monkeys that we use are quite small as well. And plus it's years and years and years of data using NHP.

所以他們想把它放在小動物身上。所以如果你把它放在小鼠或大鼠體內，那顯然是少量藥物。我們使用的猴子也很小。再加上使用 NHP 的年復一年的數據。

So I would say that swine is theoretically a long-term solution, but you'd have to have lots of validation work done by our clients, accepted by the FDA and then a massive breeding operation, which we would undertake that. It just -- it's not around the corner.

所以我想說養豬在理論上是一個長期的解決方案，但你必須讓我們的客戶完成大量的驗證工作，獲得 FDA 的認可，然後進行大規模的育種操作，我們將承擔這些工作。它只是 - 它不是指日可待。

The utilization of NHPs and a small animal model, usually a rat, is required by the FDA and comparable organizations around the world. So that's unlikely to change. I think the essence of your question as well, that's really interesting, but what if they're not available, what happens.

FDA 和世界各地的類似組織都要求使用 NHP 和小動物模型（通常是老鼠）。所以這不太可能改變。我認為你的問題的本質也是如此，這真的很有趣，但如果他們不可用，會發生什麼。

And you know that the FDA is the protector of the public safety. So they won't do anything to impair safety, biologics of complicated drugs and I mentioned human proteins or artificial human proteins. And so you really want something that is closely aligned with a human being as possible.

而且您知道 FDA 是公共安全的保護者。所以他們不會做任何損害安全性的事情，複雜藥物的生物製劑，我提到了人類蛋白質或人造人類蛋白質。所以你真的想要盡可能接近人類的東西。

So I don't see a significant pivot out of that. And would it reduce demand? I mean, if you have a host -- so let's take the worst case that Cambodia never opens up. That would beg the question of would the FDA accept smaller numbers of animals per study than they do now. I don't know the answer to that.

所以我沒有看到一個重要的支點。它會減少需求嗎？我的意思是，如果你有東道主——那麼讓我們以柬埔寨從未開放的最壞情況為例。這就引出了一個問題，即 FDA 是否會接受比現在更少的每項研究動物數量。我不知道答案。

And if they did accept that, would that be significantly -- significant enough to give them enough data to approve the drug? Maybe. Probably not. They couldn't pivot overnight to another animal model.

如果他們確實接受了這一點，那是否會很重要——足以給他們足夠的數據來批准這種藥物？或許。可能不是。他們無法在一夜之間轉向另一種動物模型。

So again, I just have to go back to where I've been on this whole call, the animals are available. There are enough animals available. The farm that we use, we provided really good oversight. And we think it's well-run farm, and we think the animals are of high quality.

所以，我只需要回到我在整個電話會議上所處的位置，動物就可以了。有足夠的動物可用。我們使用的農場提供了非常好的監督。我們認為這是一個經營良好的農場，我們認為這些動物質量很高。

And we have to get through this logjam, and it's not like -- think about your question, it's not like there literally are not enough animals available in the world to satisfy the demand because there aren't. These animals typically are pests in these countries, and then they take the pests, and they use them as initial breed stock. So they're wild.

我們必須解決這個僵局，這不像——想想你的問題，這並不是說世界上沒有足夠的動物來滿足需求，因為沒有。這些動物在這些國家通常是害蟲，然後他們把害蟲帶走，並將它們用作初始種群。所以他們很狂野。

And then we sell usually the second generation, occasionally the first, but the second generation. So the animals are clean, and we've had an opportunity to ensure their viral and bacteriological and genetic profiles are as it were -- as you want it to be.

然後我們通常賣第二代，偶爾賣第一代，但第二代。所以這些動物是乾淨的，我們有機會確保它們的病毒學、細菌學和遺傳學特徵與過去一樣——正如你希望的那樣。

So we are -- trust me, we talk daily about alternative models, what our responsibility would be, how we would go at it, how we support our clients. And that may happen over the next -- I don't know the time frame, let's say, 5 years. But that doesn't satisfy any of the short-term needs right now.

所以我們 - 相信我，我們每天都在談論替代模型，我們的責任是什麼，我們將如何去做，我們如何支持我們的客戶。這可能會在未來發生——我不知道時間框架，比方說，5 年。但這並不能滿足目前的任何短期需求。

So I do think that -- we're quite hopeful in the final analysis, organizations like NIH and the FDA will weigh it seriously about how important these animals are, support us and the work that we do, and ensure that on a long-term basis, these animals are available.

所以我確實認為——我們在最終分析中非常有希望，像 NIH 和 FDA 這樣的組織將認真權衡這些動物的重要性，支持我們和我們所做的工作，並確保長期 -術語基礎，這些動物是可用的。

And if I could ask a quick follow-up, can you help me better understand the complexity of showing parentage for NHPs? Presumably, this isn't just a 23andMe test. It's more complicated than that, but I'd love to be able to better understand that?

如果我可以快速跟進，你能幫助我更好地理解顯示 NHP 親子關係的複雜性嗎？據推測，這不僅僅是一個 23andMe 測試。它比那更複雜，但我希望能夠更好地理解它？

Yes. It's -- I don't think it's all that complicated. You just -- you're proving genetics. And there are also sort of genetic assays that are available. The issue is actually more trivial. It's just actual scale depending on how many of the animals they want tested. And how do you do that on a large enough scale quickly enough so it doesn't impede the speed, the velocity of your business?

是的。它——我不認為這一切都那麼複雜。你只是——你在證明遺傳學。還有一些可用的基因檢測。這個問題實際上更微不足道。這只是實際規模，具體取決於他們想要測試的動物數量。你如何在足夠大的範圍內足夠快地做到這一點，這樣它就不會阻礙速度，你的業務速度？

So we're hopeful. We're speaking to a few organizations right now. We're hopeful that we can enhance the technology to be able to do it faster. So that would be good for us, that would be good for our clients. And I think that to be honest speed is an issue of the regulatory folks. They just (inaudible) with it.

所以我們充滿希望。我們現在正在與一些組織交談。我們希望我們能夠增強技術，以便能夠更快地做到這一點。這對我們有好處，對我們的客戶也有好處。而且我認為說實話，速度是監管人員的問題。他們只是（聽不清）。

Our next question will come from Casey Woodring with JPMorgan.

我們的下一個問題將來自摩根大通的 Casey Woodring。

So just curious, is this your max impact from NHPs? Or do you think there's more downside to that range for 2023? I guess does that headwind include any pricing offset? Is there any way to go back to the table and renegotiate price for work that you maybe had booked last year pre-supply crunch year?

所以很好奇，這是 NHP 對您的最大影響嗎？還是您認為 2023 年該範圍還有更多下行空間？我想這種不利因素是否包括任何定價抵消？有沒有什麼辦法可以回到談判桌並重新協商您可能在去年供應緊縮年之前預訂的工作的價格？

And then just as a follow-up, how much of your existing supply will you have run through in 2023? Does that downside case that you laid out assume you'd be entering 2024 with only 40% of your NHP supply available?

然後作為後續行動，您將在 2023 年完成現有供應量的多少？您提出的不利情況是否假設您進入 2024 年時只有 40% 的 NHP 供應可用？

Yes. So I'm going to stay away from '24. Just -- it's too far away, and we don't know how this year is going to unfold in terms of access to new animals. And so the supply will be -- yes, it's hard to call what it will be going to next year, which, of course, is more than 10 months away.

是的。所以我要遠離'24。只是——太遠了，我們不知道今年在獲取新動物方面將如何展開。因此，供應量將是——是的，很難預測明年的供應情況，當然，距離明年還有 10 個多月的時間。

We believe based upon everything we know today and based upon our conversations with the Fish and Wildlife and others that the guidance range that we have out there now accommodates for sort of close to the best case and close to the worst case. And so we're pretty comfortable with that. So we like our shareholder base to just sort of get in that genre.

我們相信，基於我們今天所知道的一切，並基於我們與魚類和野生動物及其他人的對話，我們現在的指導範圍可以適應接近最好情況和最壞情況的情況。所以我們對此很滿意。所以我們希望我們的股東基礎能夠進入那種類型。

The price points for work in kind of the back half of this year and definitely for '24 continue to escalate. It might not be quite at the escalating point that we had last year to really cover our inflationary costs but meaningful prices.

今年下半年和 24 年的工作價格繼續上漲。它可能還沒有達到我們去年真正支付通貨膨脹成本但有意義的價格的升級點。

I don't know. It feels unclear as to what we do from a pricing point of view to accommodate for this lack of demand. I think we need to be paid well for the complexity of the work we do and for the animals that we have. But we may have a small amount of pricing power only if the costs go up dramatically. But I wouldn't think that we can make up much of this by significantly increasing the cost to our clients.

我不知道。從定價的角度來看，我們如何應對這種需求不足的情況還不清楚。我認為我們需要為我們所做的工作的複雜性和我們擁有的動物支付高薪。但只有當成本急劇上升時，我們才有一點定價權。但我不認為我們可以通過顯著增加客戶的成本來彌補這一點。

Our next question will come from Tim Daley with Wells Fargo.

我們的下一個問題將來自富國銀行的蒂姆戴利。

Great. First, I wanted to ask on RMS. So within the RMS organic growth guidance for the year, are you assuming any divergence in product versus service above or below the segment average?

偉大的。首先，我想問一下 RMS。因此，在今年的 RMS 有機增長指導中，您是否假設產品與服務之間存在高於或低於細分市場平均水平的差異？

And then secondly, a few quick yes, no for you, Jim, on DSA. Will you be providing intra-quarter updates to investors regarding developments in the NHP dynamics? Does your guidance assume any resumption of China NHP exports to the U.S.?

其次，Jim，在 DSA 上快速回答幾句“是”，“不是”。您是否會向投資者提供有關 NHP 動態發展的季度內更新？您的指南是否假設中國 NHP 恢復對美國的出口？

And just a quick follow on to Dan's first question on the FDA Modernization Act. Where you sit today, is there any meaningful mid- to long-term risk to the Safety Assessment addressable market due to synthetic models?

快速回答 Dan 關於 FDA 現代化法案的第一個問題。您今天坐在哪裡，由於合成模型，安全評估可尋址市場是否存在任何有意義的中長期風險？

Wow, 4-parter. So I would say that the FDA Modernization Act is well intentioned and is pointing to alternatives to the extent that they are available and viable. And we would be the first company to own those technologies were they available and viable.

哇，四人組。所以我想說 FDA 現代化法案的用意是好的，並且在可用和可行的範圍內指出了替代方案。如果這些技術可用且可行，我們將成為第一家擁有這些技術的公司。

I think that there's very limited technologies right now. We try to invest in them when we see them. We bought one company in the last 25 years. It was clearly in vitro or nonanimal based to replace an animal technology that the FDA required. It's done quite well.

我認為現在的技術非常有限。當我們看到它們時，我們會嘗試對它們進行投資。我們在過去 25 年裡收購了一家公司。它顯然是基於體外或非動物的，以取代 FDA 要求的動物技術。它做得很好。

But I remember when I made the decision to buy it many years ago, I assume by now there'd be 20 other technologies, and there simply aren't. So while the FDA Modernization Act means well and it's sort of pointing towards less animals, more sophisticated animal models, early or assays that are in vitro, I think some of that will happen.

但我記得多年前我決定購買它時，我假設現在會有 20 種其他技術，但根本沒有。因此，雖然 FDA 現代化法案意味著好，它有點指向更少的動物、更複雜的動物模型、早期或體外試驗，但我認為其中一些會發生。

I think you're going to see AI and machine learning and utilization data to decide how the trial is used potentially more in the early discovery phase to give you an indication of -- I don't know whether the new drug is likely to work as well as an old one and minimally in toxicology. We hear every month -- and I totally ignore it, by the way. We hear every month that China is opening up again for exports. I don't know why we're hearing it. I don't know who's saying it. I don't believe it.

我想你會看到人工智能和機器學習和利用數據來決定如何在早期發現階段更多地使用試驗來給你一個指示——我不知道新藥是否可能有效以及一個舊的，毒理學最少的。我們每個月都會聽到——順便說一句，我完全忽略了它。我們每個月都聽說中國再次開放出口。我不知道為什麼我們會聽到它。我不知道是誰說的。我不相信。

So China is at odds with the U.S. and probably Europe right now. They have lots of animals that would potentially give them, I don't know, but an edge, but at least access to more monkeys.

因此，中國現在與美國、可能還有歐洲存在分歧。他們有很多動物，我不知道，這可能會給他們帶來優勢，但至少可以接觸到更多的猴子。

It's hard to imagine what the scenario might be that they would open up again. So we're certainly assuming for all of our guidance and assumptions and plan that we don't have them available for us.

很難想像他們會再次開放的場景。因此，我們當然假設我們所有的指導和假設和計劃都沒有提供給我們。

You had another question -- oh, I can't imagine that we would give inter-quarter updates on DSA. So I would leave it at that.

你還有另一個問題——哦，我無法想像我們會在 DSA 上提供季度間更新。所以我會保留它。

And on the RMS business, this is a business that's really rocking right now. It's kind of moved up into sort of high single digits genre. We did 9% for fiscal '22. That's the best it's been in a long time.

在 RMS 業務方面，這是一項目前真正搖擺不定的業務。它有點上升到某種高個位數的類型。我們在 22 財年做了 9%。這是很長一段時間以來最好的。

We've got China doing well. We've got North America doing really well. I'm only laughing because it's been years since that's happened. So it happened '22 and we imagine '23 as well.

我們讓中國做得很好。我們在北美做得很好。我之所以笑，是因為那件事已經過去好幾年了。所以它發生在 22 年，我們也想像 23 年。

This CRADL business with the acquisition we made last year is doing particularly well. Our genetically engineered model business, it's also doing particularly well. And so we see a really good opportunity to take share.

我們去年收購的 CRADL 業務做得特別好。我們的基因工程模型業務也做得特別好。因此，我們看到了一個很好的分享機會。

We always get price in those businesses. Clients are pretty much happily dependent on us. It's been -- nobody produces their own animals or provides the level of services that we do. So the business feels continually stronger pretty much in all of the geographies in which we participate.

我們總是在這些業務中獲得價格。客戶非常樂意依賴我們。一直以來——沒有人生產自己的動物或提供我們所做的服務水平。因此，在我們參與的所有地區，業務都感覺越來越強大。

Some of our competitors, particularly because of COVID, had a rough time. I don't know, having enough infrastructure to work through COVID. I think they've been -- had some financial issues as well and some of them are only in the Research Model business. So I think they've had a lot of pressure on them. So we feel really good about that business, its growth rate potential and its operating margin potential and really feel good about how it ended up in '22.

我們的一些競爭對手，尤其是因為 COVID，經歷了一段艱難的時期。我不知道，有足夠的基礎設施來應對 COVID。我認為他們已經 - 也有一些財務問題，其中一些僅在研究模型業務中。所以我認為他們對他們有很大的壓力。因此，我們對該業務、它的增長率潛力和營業利潤率潛力感到非常滿意，並且對它在 22 年的結局感到非常滿意。

Our next question will come from Dave Windley with Jefferies.

我們的下一個問題將來自 Jefferies 的 Dave Windley。

Jim, I wanted to ask one on kind of availability. You touched in one of the earlier answers about the test. I wondered if you could give us a framing as to whether you think this is a test that kind of the assay exists, but you need to repurpose it and validate it in your area? Or are you kind of starting from scratch?

吉姆，我想問一個關於可用性的問題。您觸及了有關該測試的早期答案之一。我想知道您是否可以給我們一個框架，說明您是否認為這是一種存在這種檢測的測試，但您需要重新調整它的用途並在您所在的地區進行驗證？或者你是從頭開始？

And then more broadly, in terms of kind of longer-term availability of NHPs. I wonder what consideration you have given to establishing domestic colonies and/or working with U.S. primate research facilities that I think are mostly used for NIH, but is there any opportunity to leverage those for access to primates?

然後更廣泛地說，就 NHP 的長期可用性而言。我想知道您對建立國內殖民地和/或與我認為主要用於 NIH 的美國靈長類動物研究設施合作有何考慮，但是否有機會利用這些設施來接觸靈長類動物？

Yes. The domestic colony question is a really good one, David. I can't tell you how many times we've discussed it. And I think you know that we did it once. So we set up a domestic colony in Southern Florida. It's extraordinarily significant expense and had the bad luck of -- even though we have built hurricane proof enclosures, we're having a hurricane, which really ruined the bunch of the facility -- actually a bunch of monkeys got out.

是的。國內殖民地問題是一個非常好的問題，戴維。我不能告訴你我們已經討論過多少次了。我想你知道我們做過一次。所以我們在佛羅里達州南部建立了一個國內殖民地。這是一筆非常大的開支，而且運氣不佳——儘管我們已經建造了防颶風的圍欄，但我們正在經歷一場颶風，這真的毀了一堆設施——實際上一群猴子跑了出來。

The -- at the time this was a long time ago, Dave, it was -- I remember the project was like cash flow negative for over a decade. It's just a brutal drop. So you have 2 problems with it. One is it's crazy expensive now.

- 當時這是很久以前的事了，戴夫 - 我記得這個項目十多年來就像現金流為負數一樣。這只是一個殘酷的下降。所以你有兩個問題。一是現在貴得離譜。

I think underlying your question was, could you go to the Federal government and say, can you help us with this? It is a critical national resource. And they probably would. So that would take some of the financial sting out of it, but it still would take forever.

我認為你的問題的根本是，你能不能去聯邦政府說，你能幫我們解決這個問題嗎？它是重要的國家資源。他們可能會。所以這會消除一些財務上的痛苦，但它仍然需要永遠。

We're talking about what can we do between now and the end of this year. And it just would be forever. So it's just -- it's not a practical approach.

我們正在討論從現在到今年年底我們能做些什麼。這將是永遠的。所以這只是——這不是一種實用的方法。

On the test, I think it's both. The answer to your question is both. There are current tests that can be utilized but are set up not on a very large scale. So we have to scale them up or find a partner to scale them up. So minimally we'll do that.

在測試中，我認為兩者兼而有之。你的問題的答案是兩者兼而有之。目前有一些可以使用的測試，但設置的規模不是很大。因此，我們必須擴大規模或尋找合作夥伴來擴大規模。所以我們至少會這樣做。

What we're really hoping for, particularly with 1 or 2 of the collaborators that we began to talk to is that the quality of their science is so sophisticated that they can help us refine the tests in a way that we can do more, have more throughput faster with better and unequivocal results.

我們真正希望的是，尤其是我們開始與之交談的一兩個合作者，他們的科學質量如此復雜，以至於他們可以幫助我們以一種我們可以做得更多的方式改進測試，有更快的吞吐量和更好、更明確的結果。

And obviously, we got our own labs. As you know, Dave, we have big labs all around the world in our facilities. So we have really good capacity and really capable people that would know how to do this work. We just would like to get ahead of it. So it's kind of a work in progress literally as we speak. We're working on it.

顯然，我們有自己的實驗室。正如你所知，戴夫，我們在世界各地都有大型實驗室。所以我們有非常好的能力和真正有能力的人，他們知道如何做這項工作。我們只是想搶先一步。因此，正如我們所說，這實際上是一項正在進行的工作。我們正在努力。

I'm confident that we will minimally have kind of something relatively new and not yet standard and potentially something better than even something that's new that would be -- I don't care so much about the cost as speed and accuracy. So we're all over that, and we'll update you folks on what our progress is. And if the relevance of the partner assuming we have an appropriate partner. If we think that's meaningful to our shareholder base, we'll share that with you as well.

我相信我們至少會擁有一些相對較新但尚未標準的東西，甚至可能比新的東西更好——我不太關心成本，而是速度和準確性。所以我們已經結束了，我們會向大家通報我們的進展情況。如果合作夥伴的相關性假設我們有合適的合作夥伴。如果我們認為這對我們的股東基礎有意義，我們也會與您分享。

That's great. And if I could follow up on kind of the, I guess, the breadth of the effort. Do you see -- I mean you mentioned the industry understand that. Certainly makes sense to kind of be collaborative to solve an industry problem. But for your purposes, are you needing to scale this up to kind of validate parentage with your primary supplier in Cambodia? Or is it kind of needs to apply to all of Cambodia and get the U.S. government comfortable with the whole thing as opposed to just KF in your case?

那太棒了。如果我可以跟進，我想，工作的廣度。你明白嗎 - 我的意思是你提到了行業理解這一點。合作解決行業問題當然是有意義的。但出於您的目的，您是否需要擴大規模以驗證與您在柬埔寨的主要供應商的親子關係？或者它是否需要適用於整個柬埔寨並讓美國政府對整個事情感到滿意，而不是在你的情況下只是 KF？

I mean, eventually, I think it's good for the industry if you can even call what we do an industry and certainly for our clients, if you could -- certainly they are an industry. I think it would be good if the whole Cambodian source, and there are a couple of really big players and then some smaller ones -- if they could use a similar methodology to show who are the moms and who are the offsprings.

我的意思是，最終，如果你甚至可以將我們所做的稱為一個行業，當然對我們的客戶來說，如果可以的話，我認為這對這個行業是有好處的——當然他們是一個行業。我認為，如果整個柬埔寨來源，並且有幾個真正的大玩家，然後是一些較小的玩家——如果他們可以使用類似的方法來顯示誰是母親，誰是後代，那將是一件好事。

So if we're successful, we won't be selfish about it. I think the way we see the landscape right now, we're unlikely to work with anybody besides our principal supplier because we just know them so well. We like the scale at which they work, and they really take our advice and counsel really well. So we are quite confident that they work with us.

所以如果我們成功了，我們就不會自私。我認為我們現在看到的情況是，除了我們的主要供應商之外，我們不太可能與任何人合作，因為我們非常了解他們。我們喜歡他們的工作規模，他們真的很好地接受了我們的建議和建議。所以我們非常有信心他們與我們合作。

And so maybe that will be the nice edge. We'll start with our supplier. We'll work with them. We'll show Fish and Wildlife what we've accomplished. And then we can offer to share that. I don't care. We can share that with our competition. We don't have 100% share.

所以也許這將是一個很好的優勢。我們將從我們的供應商開始。我們將與他們合作。我們將向魚類和野生動物展示我們所取得的成就。然後我們可以提供分享。我不在乎。我們可以與我們的競爭對手分享這一點。我們沒有100%的份額。

So we just want the biopharmaceutical industry to be well resourced here and have access to companies that can do the work well for them. So -- and I do think that the U.S. providers are quite -- will be quite reliant on Cambodia for the foreseeable future, just given the genetic similarity between the Cambodian monkeys and the Chinese ones. And it's much better for the research just sort of background data point of view.

因此，我們只希望生物製藥行業在這裡擁有充足的資源，並能夠接觸到能夠為他們做好工作的公司。所以——我確實認為美國供應商相當——在可預見的未來將相當依賴柬埔寨，只是考慮到柬埔寨猴子和中國猴子之間的基因相似性。從背景數據的角度來看，這對研究來說要好得多。

So that's how we see it unfolding. It's possible that our competition will do something similar. And maybe they get there first. I don't even care. We're not going to spend a lot of time, I think, working with them because we just have a different, I think, viewpoints and capabilities and scale and just the way we deal with suppliers and the government. So while we may talk to them and get each other's support, I think we have to do this alone. And I think we have to do it quite quickly.

這就是我們看到它展開的方式。我們的競爭對手可能會做類似的事情。也許他們先到達那裡。我什至不在乎。我認為，我們不會花很多時間與他們合作，因為我認為我們只是有不同的觀點、能力和規模，以及我們與供應商和政府打交道的方式。因此，雖然我們可以與他們交談並獲得彼此的支持，但我認為我們必須獨自完成。我認為我們必須盡快完成。

Thank you. Ladies and gentlemen, we have reached our allotted time for questions, and this does conclude today's Charles River Laboratories Fourth Quarter and Full Year 2022 Earnings Call. Thank you for your participation, and you may now disconnect.

謝謝。女士們，先生們，我們已經到了規定的提問時間，今天的 Charles River Laboratories 第四季度和 2022 年全年收益電話會議到此結束。感謝您的參與，您現在可以斷開連接。