Catalent Inc (CTLT) 2023 Q3 法說會逐字稿

Ladies and gentlemen, good morning. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Catalent, Inc. Third Quarter 2023 Business Update Conference Call. Today's conference is being recorded. (Operator Instructions) Thank you.

女士們，先生們，早上好。我叫艾比，今天我將擔任你們的會議接線員。此時，我想歡迎大家參加 Catalent, Inc. 2023 年第三季度業務更新電話會議。今天的會議正在錄製中。 （操作員說明）謝謝。

And I will now turn the conference over to Paul Surdez, Vice President of Investor Relations. You may begin.

我現在將會議轉交給投資者關係副總裁 Paul Surdez。你可以開始了。

Good morning, everyone, and thank you for joining us today. Instead of our normal review of Catalent's third quarter 2023 financial results, Alessandro Maselli, Catalent's President and Chief Executive Officer, will provide you with a status update; and then Ricky Hopson, Senior Vice President and Interim Chief Financial Officer, will discuss our capital position and our revised outlook for fiscal '23. Mr. Maselli will provide some final remarks, and then we will take your questions.

大家早上好，感謝您今天加入我們。 Catalent 總裁兼首席執行官 Alessandro Maselli 將為您提供狀態更新，而不是我們對 Catalent 2023 年第三季度財務業績的正常審查；然後，高級副總裁兼臨時首席財務官 Ricky Hopson 將討論我們的資本狀況和我們修訂後的 23 財年展望。 Maselli 先生將發表最後的評論，然後我們將回答您的問題。

During our call today, management will make forward-looking statements and refer to non-GAAP financial measures. It is possible that future results could differ from management's expectations. Please refer to Slide 2 in the supplemental presentation available on our Investor Relations website at investor.catalent.com for a discussion of risks and uncertainties that could cause actual performance or results to differ from what is suggested by those forward-looking statements, and Slides 3 and 4 for a discussion of Catalent's use of non-GAAP financial measures.

在我們今天的電話會議中，管理層將做出前瞻性陳述並參考非 GAAP 財務指標。未來的結果可能與管理層的預期不同。請參閱我們的投資者關係網站 investor.catalent.com 上提供的補充演示文稿中的幻燈片 2，討論可能導致實際業績或結果與這些前瞻性陳述和幻燈片所建議的不同的風險和不確定性圖 3 和 4 討論了 Catalent 使用非 GAAP 財務措施。

Now I will turn the call over to Alessandro, whose opening remarks will begin with Slide 5 of the presentation. Please go ahead.

現在我將把電話轉給亞歷山德羅，他的開場白將從演示文稿的幻燈片 5 開始。請繼續。

Thank you, Paul, and thank you to everyone who has joined the call today. I'll cut to the chase. This is not at all the call that we expected to [have now], and we are not at all where we expected to be. Our financial performance and operational execution have all fallen significantly short of our expectations and our February forecast, and we accept the responsibility for disappointing you.

謝謝保羅，也感謝今天加入電話會議的所有人。我會切入正題。這根本不是我們 [現在] 期望的電話，我們根本不在我們期望的位置。我們的財務業績和運營執行都大大低於我們的預期和我們 2 月份的預測，我們承擔讓您失望的責任。

It should also not be taking us this long to finalize our financial reports, even though we and our third-party advisers have been using this time to engage in a deep and thorough review of our accounts and our financial reporting policies. Because that work is ongoing, there are a few specific details I can provide today regarding our financial performance, but I will share what news I can, give you a sense of how we got to where we are and explain our path forward.

我們也不應該花這麼長時間來完成我們的財務報告，儘管我們和我們的第三方顧問一直在利用這段時間對我們的賬戶和我們的財務報告政策進行深入和徹底的審查。因為這項工作正在進行中，所以我今天可以提供一些關於我們財務業績的具體細節，但我會分享我能分享的新聞，讓您了解我們是如何走到今天這一步的，並解釋我們前進的道路。

As we indicated in our April 14 and May 8 business updates, a combination of operational and productivity issues, as well as forecasting challenges, have led us to significantly reduce both our fiscal '23 net revenue and adjusted EBITDA guidance. We are now reducing our fiscal '23 net revenue guidance to a range from $4.25 billion to $4.35 billion, and we are reducing our adjusted EBITDA guidance to range from $725 million to $775 million. It is important to note that these ranges reflect that our significant gene therapy product begin to be treated in the third quarter as a commercial product for accounting purposes. And while our evaluation remains ongoing, we anticipate continuing to record revenue for this product entirely on a percentage of completion basis.

正如我們在 4 月 14 日和 5 月 8 日的業務更新中指出的那樣，運營和生產力問題以及預測挑戰的結合導致我們大幅減少了 23 財年的淨收入和調整後的 EBITDA 指導。我們現在將 23 財年淨收入指引下調至 42.5 億美元至 43.5 億美元，並將調整後的 EBITDA 指引下調至 7.25 億美元至 7.75 億美元。重要的是要注意，這些範圍反映了我們重要的基因治療產品在第三季度開始被視為出於會計目的的商業產品。雖然我們的評估仍在進行中，但我們預計將繼續完全根據完成百分比記錄該產品的收入。

I understand how disappointing our further revised guidance is for all of you. I share your disappointment. Catalent has established itself as a global leader in drug manufacturing and delivery and produced exceptional results to investors and patients over the past several years. But as your CEO, I'm responsible, not only for the successes, but also for our poor performance this quarter and this year. I am committed to putting Catalent back on track, to assure a stronger fiscal '24 and that we return to building long-term shareholder value.

我理解我們進一步修訂的指南對你們所有人來說是多麼令人失望。我和你一樣失望。 Catalent 已經確立了自己在藥品製造和交付領域的全球領先地位，並在過去幾年中為投資者和患者帶來了非凡的成果。但作為你們的首席執行官，我不僅要對成功負責，還要對我們本季度和今年的糟糕表現負責。我致力於讓 Catalent 重回正軌，以確保更強大的 24 財年，並確保我們重新建立長期股東價值。

To that end, on this call, I will explain to you the operational challenges and other issues that contributed to our expected Q3 results and revised guidance. This will include walking you through the reasons why we believe that the operational challenges behind this quarter's disappointing performance and revised outlook are temporary and addressable. I'll then outline the actions we have taken to increase the rigor and discipline in our forecasting. I'll also briefly discuss the factors, including our accounting adjustments at Bloomington, that are expected to lead to the filing of an amended 10-K for fiscal '22 and that delayed the filing of our third quarter fiscal '23 10-Q. Finally and most importantly, I'll remind you of our positive long-term vision, a vision that, while fully reflective of our short-term challenges, continues to look to Catalent's long-term opportunities, performance and growth with confidence and optimism.

為此，在這次電話會議上，我將向您解釋運營挑戰和其他促成我們預期的第三季度結果和修訂指南的問題。這將包括向您解釋為什麼我們認為本季度令人失望的業績和修訂後的前景背後的運營挑戰是暫時的且可以解決的。然後，我將概述我們為提高預測的嚴謹性和紀律性而採取的行動。我還將簡要討論一些因素，包括我們在布盧明頓的會計調整，這些因素預計將導致提交修訂後的 22 財年 10-K，並推遲提交我們第三季度的 23 財年 10-Q。最後也是最重要的是，我會提醒您我們積極的長期願景，這一願景在充分反映我們的短期挑戰的同時，繼續以自信和樂觀的態度看待康泰倫特的長期機遇、業績和增長。

Catalent remains a great company, and we are committed to remaining our customers' #1 CDMO partner in helping pharmaceutical, biotech and health innovators develop, deliver and supply products that improve people's lives.

Catalent 仍然是一家偉大的公司，我們致力於繼續成為客戶的第一 CDMO 合作夥伴，幫助製藥、生物技術和健康創新者開發、交付和供應改善人們生活的產品。

Before I do that, let me reassure you regarding some concerns we have heard from investors over the last few weeks. The disappointing third quarter results we expect to report were not due to any GMP compliance issues or the loss of any customer or canceled order. Our customer supply situation remained healthy and we believe we can sufficiently service their demand. We continue to be an essential part of innovator's drug manufacturing and delivery solutions that positively impact patients. We continue to win significant new business. Recent notable examples of these include a new expansion of our long-term supply agreements with both Novo Nordisk and Samsung Bioepis.

在我這樣做之前，讓我向你保證過去幾週我們從投資者那裡聽到的一些擔憂。我們預期報告的令人失望的第三季度業績不是由於任何 GMP 合規性問題或任何客戶流失或訂單取消所致。我們的客戶供應狀況保持健康，我們相信我們能夠充分滿足他們的需求。我們繼續成為創新者藥物製造和交付解決方案的重要組成部分，這些解決方案對患者產生積極影響。我們繼續贏得重要的新業務。最近值得注意的例子包括我們與 Novo Nordisk 和 Samsung Bioepis 的長期供應協議的新擴展。

With that, let's review the operational challenges that materially and adversely impacted the EBITDA in the third quarter and our full year guidance.

有了這個，讓我們回顧一下對第三季度的 EBITDA 和我們的全年指導產生重大和不利影響的運營挑戰。

As we first communicated on April 14, during the third quarter, we began to identify productivity challenges and higher-than-expected costs at our drug product manufacturing facilities located in Bloomington and Brussels. These issues drove our EBITDA reduction in our reduced revised guidance to be greater than our revenue reduction due to the following dynamics.

正如我們在 4 月 14 日首次溝通的那樣，在第三季度，我們開始發現位於布盧明頓和布魯塞爾的藥品生產設施的生產力挑戰和高於預期的成本。由於以下動態，這些問題導致我們在修訂後的指引中減少的 EBITDA 大於我們的收入減少。

First, even where revenues were delayed or missed, the majority of the labor and overhead costs remained. Second, our plans to reduce our cost base were delayed in order to implement the corrective and preventative actions following the regulatory inspections earlier in the fiscal year in our Biologics segment. Finally, balance sheet adjustment in inventory reserves for soon-to-expire biomanufacturing components and raw materials procured during the height of the pandemic are adding a larger-than-normal onetime impact on our profitability. Our gene therapy manufacturing operations in Maryland also faced unforeseen challenges as we scale up commercial volumes, requiring a new ERP system, and successfully completed 3 regulatory inspections.

首先，即使收入延遲或錯過，大部分勞動力和管理費用仍然存在。其次，我們推遲了降低成本基礎的計劃，以便在本財年早些時候對我們的生物製品部門進行監管檢查後實施糾正和預防措施。最後，在大流行高峰期採購的即將到期的生物製造組件和原材料的庫存儲備的資產負債表調整正在對我們的盈利能力產生大於正常的一次性影響。我們在馬里蘭州的基因治療製造業務也面臨著不可預見的挑戰，因為我們擴大了商業規模，需要新的 ERP 系統，並成功完成了 3 次監管檢查。

Stepping back, I believe a root cause of these challenges and increased costs are 2 different COVID cliffs, that we experienced: A revenue cliff and an unprecedented operational cliff. Allow me to explain.

退一步說，我認為這些挑戰和成本增加的根本原因是我們經歷過的 2 個不同的 COVID 懸崖：收入懸崖和前所未有的運營懸崖。請允許我解釋一下。

In the last year, when we have spoken of the COVID cliff, we usually meant the significant decline in revenue as the world emerged from the worst of the pandemic, which occurred much faster than expected or forecasted. For Catalent, that is expected to translate into slightly more than 50% decline in our fiscal '23 COVID-related revenues compared to fiscal '22, when COVID-related revenue was approximately $1.3 billion, with well over half of these being tied to take-or-pay or related component sourcing agreements. While we expect some combination of COVID and other mRNA respiratory vaccines to remain a meaningful part of our revenue stream in the years to come, we don't have enough information at this point to forecast the expected full year impact in fiscal '24, although we are planning for a significant year-on-year reduction.

去年，當我們談到 COVID 懸崖時，我們通常指的是隨著世界擺脫最嚴重的大流行病而出現的收入大幅下降，這種情況發生的速度比預期或預測的要快得多。對於 Catalent，與 22 財年相比，這預計將導致我們 23 財年與 COVID 相關的收入下降略超過 50%，當時與 COVID 相關的收入約為 13 億美元，其中超過一半與收購有關- 或支付或相關的組件採購協議。雖然我們預計 COVID 和其他 mRNA 呼吸道疫苗的某種組合在未來幾年仍將是我們收入流的重要組成部分，但我們目前沒有足夠的信息來預測 24 財年的預期全年影響，儘管我們計劃同比大幅減少。

But this significant drop in COVID-related revenues doesn't tell the whole story. As you know, our people did an extraordinary job expanding our operations to meet the demands placed on us by the global pandemic response. Between meeting the unprecedented COVID vaccine demand and implementing growth initiatives to capitalize on the stronger longer-term growth potential in biologics, we expanded very quickly since the end of fiscal '19, including by added approximately 7,000 more worker, roughly doubling our workforce and investing over $3.5 billion across our network, some of which was intended to help offset the revenue gap that would inevitably emerge once the COVID crisis faded.

但與 COVID 相關的收入大幅下降並不能說明全部情況。如您所知，我們的員工在擴大我們的業務以滿足全球大流行應對措施對我們提出的要求方面做得非常出色。在滿足前所未有的 COVID 疫苗需求和實施增長計劃以利用生物製品更強勁的長期增長潛力之間，我們自 19 財年末以來迅速擴張，包括增加了約 7,000 名員工，使我們的勞動力和投資增加了一倍左右我們的網絡投入了超過 35 億美元，其中一些用於幫助彌補 COVID 危機消退後不可避免會出現的收入缺口。

We know now that we entered fiscal '23 overly optimistic about our current year growth. Our personnel and key processes simply did not keep pace with the dramatic up-and-down swings caused by COVID. And not only had some of the anticipated revenue offsets not materialized as quick as expected, but it has proven much more complicated to exit the pandemic operationally at these impacted sites. Most importantly, we have not been able to reduce the costs that we added to the company, including personnel, material and inventory, as rapidly as needed.

我們現在知道，我們進入 23 財年時對本年度的增長過於樂觀。我們的人員和關鍵流程根本跟不上由 COVID 引起的劇烈上下波動。不僅一些預期的收入抵消沒有像預期的那樣迅速實現，而且事實證明，在這些受影響的地點從操作上擺脫大流行要復雜得多。最重要的是，我們無法根據需要盡快降低我們增加給公司的成本，包括人員、材料和庫存。

This is the operational COVID cliff I mentioned driven by the extraordinary unprecedented complexity involved in implementing the operational changes required to execute the COVID programs and then pivot to produce the non-COVID programs that would offset those revenues and fuel our future growth. I believe we have made solid progress in replacing those revenues with the new sources that will ultimately produce sustainable long-term growth. However, it is now clear that we underestimated the related operational challenges, and that forecasting suffered as a result. Now that we fully recognized the depth of the challenges, we are addressing them in a rapid, focused manner.

這是我提到的運營 COVID 懸崖，其驅動因素是實施執行 COVID 計劃所需的運營變更所涉及的前所未有的複雜性，然後轉向生產將抵消這些收入並推動我們未來增長的非 COVID 計劃。我相信我們在用最終將產生可持續長期增長的新來源取代這些收入方面取得了堅實的進展。然而，現在很明顯，我們低估了相關的運營挑戰，結果預測受到了影響。既然我們已經充分認識到挑戰的嚴重性，我們將以快速、集中的方式應對這些挑戰。

Let me transition to forecasting. Whenever actual results have varied materially from our expectations and projections, our underlying assumptions proved substantially inaccurate, it is time to reassess our forecasting rigor and discipline. This includes moderating our short-term optimism by more thoroughly assessing and integrating the negative impact of the recent macro events that have had and continue to have a material impact on our business. This includes the significant contraction in biotech funding, which is especially impactful for newer modalities.

讓我過渡到預測。每當實際結果與我們的預期和預測存在重大差異時，我們的基本假設被證明是非常不准確的，是時候重新評估我們預測的嚴謹性和紀律性了。這包括通過更徹底地評估和整合最近已經並將繼續對我們的業務產生重大影響的宏觀事件的負面影響來緩和我們的短期樂觀情緒。這包括生物技術資金的顯著收縮，這對新模式的影響尤其大。

At the same time, we are building the foundations of our demand-planning process in our biologics segment. We have also conducted a root cause analysis of our forecasting to improve our understanding of the internal operational drivers that led us to such inaccuracies. In Bloomington and Brussels, we are more effectively weighting the temporary impact of productivity challenges and higher-than-expected costs, including those associated with the regulatory remediation that generated adverse manufacturing variances.

與此同時，我們正在為我們的生物製品部門的需求規劃流程奠定基礎。我們還對我們的預測進行了根本原因分析，以加深我們對導致我們出現此類錯誤的內部運營驅動因素的理解。在布盧明頓和布魯塞爾，我們正在更有效地權衡生產力挑戰和高於預期的成本的臨時影響，包括那些與產生不利製造差異的監管補救措施相關的影響。

In Bloomington, we expected some large product tech transfers to help offset the lower COVID demand at the sites. Those tech transfers turned out to be more complex and are taking longer than anticipated, resulting in overly ambitious forecasts. Most of these hurdles have now been overcome, and we expect these transfers to complete in the second half of this calendar year. On the positive side, some of these tech transfers customers are now adding [run-in] to Bloomington for their fill-and-finish work.

在布盧明頓，我們預計會進行一些大型產品技術轉讓，以幫助抵消現場較低的 COVID 需求。事實證明，這些技術轉讓更加複雜，花費的時間比預期的要長，導致預測過於雄心勃勃。大多數障礙現在已經被克服，我們預計這些轉移將在本日曆年下半年完成。從積極的方面來看，這些技術轉讓客戶中的一些現在正在為他們的填充和完成工作添加 [磨合] 到布盧明頓。

Gene therapy has been our brightest spot this year, including a rapid growth in the first half of the year as we scaled the business, but we experienced significant unforeseen operational challenges in the business in the third quarter. These challenges have continued into the beginning of the fourth quarter as we increased the capacity to serve growing demand.

基因治療一直是我們今年的亮點，隨著我們擴大業務規模，上半年實現了快速增長，但我們在第三季度的業務中遇到了重大的不可預見的運營挑戰。隨著我們提高服務於不斷增長的需求的能力，這些挑戰一直持續到第四季度初。

As we first communicated on April 14, one of the key issues here involved the replacing of BWI's prior ERP system, which was better suited for smaller clinical and development operations. While the implementation of the new ERP was critical to support the fundamentally bigger commercial operations at BWI, the challenges we experienced in the implementation delayed the ramp-up of this additional capacity until [early day]. Again, these challenges were temporary and will not affect any customer as we have previously built the sufficient bright stock to support their immediate needs, and we are now producing in normal fashion.

正如我們在 4 月 14 日首次溝通時，這裡的一個關鍵問題涉及更換 BWI 之前的 ERP 系統，該系統更適合小型臨床和開發業務。雖然新 ERP 的實施對於支持 BWI 從根本上擴大商業運營至關重要，但我們在實施過程中遇到的挑戰推遲了這一額外產能的提升，直到 [清晨]。同樣，這些挑戰是暫時的，不會影響任何客戶，因為我們之前已經建立了足夠的明亮庫存來支持他們的即時需求，而且我們現在正在以正常方式生產。

Our focus in our Pharma and Consumer Health segment have also been too optimistic. This is a segment where we expected a strong growth as we started the year, modified our expectations to much more modest growth in November and February, and now tracking to flat organic revenue growth for the full year.

我們對製藥和消費者健康領域的關注也過於樂觀。這是一個我們預計今年年初將實現強勁增長的細分市場，將我們的預期修改為 11 月和 2 月的溫和增長，現在全年有機收入增長持平。

The main headwinds here are: More pronounced declines in some existing commercial line value pharmaceutical products; delayed launches of some promising new prescription products; and lower consumer demand, particularly for gummies and higher -- and other high-end nutritional supplements. We are confident that the segment will return to organic growth in the coming quarters, given the growth we see in our core development revenue, the expected rebound of a top product for the segment that has experienced supply chain challenges in fiscal '23, the continuing strong demand that we see for our Zydis platform, and the expected launches of 10 products recently approved by the FDA.

這裡的主要不利因素是： 一些現有商業線價值醫藥產品的下降更為明顯；延遲推出一些有前途的新處方產品；消費者需求降低，尤其是對軟糖和高級營養品以及其他高端營養品的需求。我們有信心該部門將在未來幾個季度恢復有機增長，鑑於我們在核心開發收入中看到的增長，該部門在 23 財年經歷供應鏈挑戰的頂級產品的預期反彈，持續的我們看到對 Zydis 平台的強勁需求，以及 FDA 最近批准的 10 種產品的預期推出。

To recap, we have reviewed the procedure with which we execute our precise processes to determine how macro events impacted our ability to meet our forecast. After delivering 3 years of exemplary performance, we are bringing back more rigor and skepticism, such as known and previously unforeseen macro and internal operations drivers. At the same time, we now recognize the need to reflect better the increased level of complexity involved in this new phase of our business. While it is difficult to assign precise figures to the impact of this operational and forecasting challenges, we attribute about the same magnitude of those 2 items in our overall net revenue and EBITDA guidance adjustments.

回顧一下，我們審查了我們執行精確流程的程序，以確定宏觀事件如何影響我們滿足預測的能力。在提供了 3 年的模範表現之後，我們正在帶回更多的嚴謹和懷疑，例如已知的和以前無法預料的宏觀和內部運營驅動因素。與此同時，我們現在認識到需要更好地反映我們業務新階段所涉及的日益複雜的水平。雖然很難為這種運營和預測挑戰的影響分配精確的數字，但我們將這兩個項目的大小歸因於我們的整體淨收入和 EBITDA 指導調整。

Concurrently, and in conjunction with the change in our finance leadership, we have conducted an independent third-party balance sheet review at the 2 largest sites in our biologics segment: Bloomington and BWI. Most importantly, this balance sheet review reaffirmed its overall soundness, including our contract asset balances.

同時，結合我們財務領導層的變化，我們在我們生物製品部門的兩個最大地點：布盧明頓和 BWI 進行了獨立的第三方資產負債表審查。最重要的是，此次資產負債表審查重申了其整體穩健性，包括我們的合同資產餘額。

In all, we expect to record a few accounting adjustments at Bloomington. One example, we expect to increase our inventory reserve by roughly $55 million related to [sustain] the raw materials and component to ensure the safety stock to minimize pandemic-related supply chain shortages. We're also expected to correct a $26 million recognition error related to the fourth quarter of fiscal '22. Separately, given our lower growth expectations for our consumer health business, we also expect to report a goodwill impairment in that business in excess of $200 million.

總之，我們預計布盧明頓將進行一些會計調整。例如，我們預計將與 [維持] 原材料和組件相關的庫存儲備增加約 5500 萬美元，以確保安全庫存，從而最大限度地減少與大流行相關的供應鏈短缺。我們還預計將糾正與 22 財年第四季度相關的 2600 萬美元的識別錯誤。另外，鑑於我們對消費者健康業務的增長預期較低，我們還預計該業務的商譽減值將超過 2 億美元。

Properly assessing and addressing the effect of these adjustments on our previously issued financial statements, including those in our most recent 10-K and our 10-Qs for the current fiscal year, as well as their effects on our internal control over financial reporting and disclosure control and procedures, are contributing to our delay in finalizing our third quarter 10-Q. When our assessment is complete, we will fully explain to our investors these prior period changes and their effects, including their effects on our internal controls. We very much appreciate the patience of our shareholders as we work to resolve these issues in a timely fashion.

正確評估和解決這些調整對我們之前發布的財務報表的影響，包括我們最近的 10-K 和我們當前財政年度的 10-Q，以及它們對我們對財務報告和披露的內部控制的影響控制和程序，導致我們延遲完成第三季度 10-Q。當我們的評估完成後，我們將向我們的投資者充分解釋這些前期變化及其影響，包括它們對我們內部控制的影響。在我們努力及時解決這些問題的過程中，我們非常感謝股東們的耐心等待。

Moving on to a review of our manufacturing operations. We have taken several corrective actions at BWI and Bloomington, including both management and operational changes, to address the root causes of the issues identified at each site. The operational changes include more rigorous demand planning, deployment of additional Six Sigma Black Belt resources to recover previously experienced productivity levels and a holistic cost review to adopt the future organizational structure to the new outlook on our demand. We expect that these actions to bring us back progressively to typical profitability levels at these locations.

繼續審查我們的製造業務。我們已在 BWI 和布盧明頓採取多項糾正措施，包括管理和運營變革，以解決每個站點所發現問題的根本原因。運營變化包括更嚴格的需求規劃、部署額外的六西格碼黑帶資源以恢復以前的生產力水平，以及全面成本審查以採用未來的組織結構來滿足我們對需求的新展望。我們希望這些行動能使我們逐步恢復到這些地點的典型盈利水平。

We have also made a number of important leadership changes. We announced on April 14 that we appointed Ricky Hopson to serve as our Interim Chief Financial Officer. Ricky is an experienced finance executive and operational finance expert who deeply understands Catalent and can successfully lead our financial function through this interim period as we search for a permanent CFO. We also made the changes in the finance organization -- other changes in the finance organization in the last month, including changing the finance directors at the sites with the greatest challenges.

我們還進行了一些重要的領導層變動。我們於 4 月 14 日宣布任命 Ricky Hopson 擔任我們的臨時首席財務官。 Ricky 是一位經驗豐富的財務主管和運營財務專家，他對 Catalent 有深刻的了解，並且可以在我們尋找永久首席財務官的這段過渡時期成功領導我們的財務職能。我們還對財務組織進行了調整——上個月對財務組織進行了其他調整，包括更換面臨最大挑戰的站點的財務總監。

On the operations side, we made several executive leadership changes in our biologics segment. As just one example, we are pleased that Ricardo Zayas, a proven biologics operations leader with a vast industry experience, who joined Catalent in January, will now lead our operations worldwide across the biologics segment.

在運營方面，我們對生物製劑部門進行了多項行政領導變動。僅舉一個例子，我們很高興里卡多·扎亞斯 (Ricardo Zayas) 是一位久經考驗的生物製劑運營領導者，擁有豐富的行業經驗，他於 1 月加入 Catalent，現在將領導我們在全球生物製劑領域的運營。

In addition, in early March, we announced that Sridhar Krishnan, a 20-year industry expert in Lean Six Sigma, had returned to Catalent to reignite The Catalent Way. The Catalent Way is company-wide system of continuous improvement and lean manufacturing with clear standards to enable more predictable and efficient processes.

此外，在 3 月初，我們宣佈在精益六西格碼方面擁有 20 年經驗的行業專家 Sridhar Krishnan 已返回康泰倫特，重新點燃康泰倫特之道。 Catalent Way 是公司範圍內的持續改進和精益製造系統，具有明確的標準，可實現更可預測和更高效的流程。

When I speak about rigor, it also means effectively managing costs and cash to ensure we drive the company's expected profitability. We have developed another cost reduction plan intended to drive margins more aligned to our historical levels, with a goal to double our previously committed $75 million to $85 million of annualized run rate savings from restructuring activities. In addition, we are limiting our CapEx to only essential investments, and we are also actively evaluating our current portfolio to ensure we have a suite of business that achieve a sustainable, profitable and capital-efficient growth that delivers superior shareholder values.

當我談到嚴謹時，它還意味著有效地管理成本和現金，以確保我們推動公司的預期盈利能力。我們制定了另一項成本削減計劃，旨在推動利潤率與我們的歷史水平更加一致，目標是將我們之前承諾的重組活動每年節省 7500 萬至 8500 萬美元的費用翻一番。此外，我們將我們的資本支出僅限於必要的投資，我們也在積極評估我們當前的投資組合，以確保我們擁有一套業務，能夠實現可持續、盈利和資本高效的增長，從而提供卓越的股東價值。

I want to reiterate my disappointment in having to deliver this news. My team and I accept responsibility for falling short of your expectations and ours. We nonetheless remain committed to Catalent's long-term vision. The secular trends in our overall business and operating environment remain fundamentally strong. We operate in generally excellent markets with industry-leading services and capabilities to meet customer needs.

我想重申我對必須傳達這個消息感到失望。我和我的團隊為未能達到您和我們的期望承擔責任。儘管如此，我們仍然致力於 Catalent 的長期願景。我們整體業務和運營環境的長期趨勢從根本上來說仍然強勁。我們在普遍優秀的市場中運營，提供行業領先的服務和能力來滿足客戶的需求。

We are proud of our regulatory effort, including this year, where in the last 6 months, we underwent 9 successful FDA inspections, only a few of which included observations, and all of those can be readily addressed. Among these successful inspections were 2 PAI inspections at our gene therapy sites in support of a significant product.

我們為我們的監管工作感到自豪，包括今年，在過去的 6 個月裡，我們成功地接受了 9 次 FDA 檢查，其中只有少數包括觀察，所有這些都可以輕鬆解決。在這些成功的檢查中，有 2 次 PAI 檢查在我們的基因治療場所進行，以支持一個重要的產品。

We also see strong current and future demand for our broad platform of services. And while lower biotech funding has impacted some near-term demand for some of our offerings in the newer modalities further away from commercialization, those assets that are closer to commercial approval or those that have already been approved, which is well over half of our revenue when combined, has continued their ordering process as expected.

我們還看到當前和未來對我們廣泛的服務平台的強勁需求。雖然較低的生物技術資金已經影響了對我們距離商業化更遠的較新模式的一些產品的短期需求，但那些更接近商業批准或已經獲得批准的資產，占我們收入的一半以上合併後，已按預期繼續其訂購流程。

We have also invested hundreds of millions of dollars in assets that are getting ready to be deployed as dictated by the market demand. This included the additional new suites in BWI that are now expected to be completed in fiscal '24; 2 state-of-the-art sterile syringe line, 1 in Anagni, 1 in Bloomington; and a high capacity expansion of our Zydis offering.

我們還投資了數億美元的資產，這些資產正準備根據市場需求進行部署。這包括 BWI 的額外新套房，現在預計將在 24 財年完工； 2條最先進的無菌注射器生產線，1條在阿納尼，1條在布盧明頓；以及我們 Zydis 產品的高容量擴展。

We estimate that, when we reach the planned level of utilization of this larger footprint, we will be able to generate $6.5 billion in annual revenue without the need for substantial new growth capital investments. We will let you know as soon as we are ready to announce our full quarterly results and provide any necessary further detail regarding revision to our prior financial statements.

我們估計，當我們達到這個更大足蹟的計劃利用率時，我們將能夠產生 65 億美元的年收入，而無需大量新的增長資本投資。一旦我們準備好公佈我們的完整季度業績，並提供有關修訂我們先前財務報表的任何必要的進一步細節，我們將盡快通知您。

I will now turn the call over to Ricky for a discussion of our capital position and expected fiscal '23 results.

我現在將電話轉給 Ricky，討論我們的資本狀況和預期的 23 財年業績。

Thank you, Alessandro. Turning first to our capital position and our debt load, as discussed on Slide 6, which we now intend to reduce more aggressively, remains well structured and permits good flexibility. Our nearest maturity is not until 2027.

謝謝你，亞歷山德羅。首先轉向我們的資本狀況和我們的債務負擔，如幻燈片 6 中所討論的，我們現在打算更積極地減少，但結構良好並具有良好的靈活性。我們最近的成熟期要到 2027 年。

Our most rigorous debt covenant is the ratio of first lien debt over the last 12 months of adjusted EBITDA at 6.5x. This ratio, at December 31, 2022, was roughly 1.6x and is expected to increase for the next several quarters before diminishing again in the back half of fiscal '24. This covenant ratio is expected to remain well below the permitted level throughout this period.

我們最嚴格的債務契約是過去 12 個月調整後 EBITDA 的優先留置權債務比率為 6.5 倍。截至 2022 年 12 月 31 日，這一比率約為 1.6 倍，預計在接下來的幾個季度中會增加，然後在 24 財年的後半段再次下降。在此期間，該契約比率預計將遠低於允許的水平。

Our top priority is for positive cash generation and allocation of capital which will support our efforts back towards our net leverage target of 3.0x, include greater utilization of our asset base, completion of essential in-flight CapEx projects that we believe will add -- will generate positive returns in the short term, activities that will reduce our cost base and contract negotiations to reduce our cash conversion cycle. We expect to report our contract assets as of March 31, 2023, to be roughly flat with that of December 31, 2022 balance.

我們的首要任務是產生積極的現金和分配資本，這將支持我們努力回到 3.0 倍的淨槓桿目標，包括提高我們資產基礎的利用率，完成我們認為將增加的重要的飛行資本支出項目——將在短期內產生正回報，活動將減少我們的成本基礎和合同談判以減少我們的現金轉換週期。我們預計報告截至 2023 年 3 月 31 日的合同資產與 2022 年 12 月 31 日的餘額大致持平。

I understand the level of contract assets has been a top investor concern. So in one of my first actions as interim CFO, I initiated an independent review of the balance sheet, including contract assets at 2 of our largest sites in our biologics segment, Bloomington and BWI. The review reaffirmed the overall soundness of our balance sheet, including our biologics contract asset balances, some of which are related to nearly completed products, including the bright stock Alessandro mentioned earlier.

據我所知，合同資產水平一直是投資者最關心的問題。因此，在我作為臨時首席財務官的第一個行動中，我開始對資產負債表進行獨立審查，包括我們生物製品部門最大的兩個地點布盧明頓和 BWI 的合同資產。審查重申了我們資產負債表的整體穩健性，包括我們的生物製劑合同資產餘額，其中一些與接近完成的產品有關，包括前面提到的光明股票 Alessandro。

Also related to contract assets. The revenue accounting treatment for complex products with long production cycles will continue to be recognized on a percentage of completion basis when contract terminology determines our work related to commercial activity.

也與合同資產有關。當合同術語確定我們與商業活動相關的工作時，對於生產週期長的複雜產品的收入會計處理將繼續按完成百分比確認。

Note, in the third quarter, there was a change in contract terms to a large gene therapy program that drove a change in characterization from development to commercial activity, so the percentage of completion method we have been using all along will not change. We are looking at other contract terms that may partially modify our accounting for this product. This is one reason for the delay in finalizing our third quarter results.

請注意，在第三季度，大型基因治療項目的合同條款發生了變化，導致了從開發到商業活動的特徵變化，因此我們一直使用的完成百分比方法不會改變。我們正在研究可能會部分修改我們對該產品的會計處理的其他合同條款。這是延遲完成第三季度業績的原因之一。

Finally, we now expect our fiscal '23 CapEx to be approximately $550 million versus our previous estimate of approximately $500 million. When taking into account the billions of dollars of capital investments we have already made in the business, in fiscal 2024, we expect to be able to reduce our CapEx to only the most critical projects, leading to a notably lower spend.

最後，我們現在預計我們的 23 財年資本支出約為 5.5 億美元，而我們之前的估計約為 5 億美元。考慮到我們已經在該業務中進行的數十億美元的資本投資，到 2024 財年，我們預計能夠將我們的資本支出減少到僅用於最關鍵的項目，從而顯著降低支出。

Now we turn to our revised financial outlook for fiscal 2023 as outlined on Slide 7. We now expect fiscal '23 net revenue in the range of $4.25 billion up to $4.35 billion. We now expect adjusted EBITDA in a range from $725 million up to $775 million. We now expect adjusted net income in a range from $187 million up to $228 million.

現在我們轉向幻燈片 7 中概述的修訂後的 2023 財年財務展望。我們現在預計 23 財年的淨收入在 42.5 億美元至 43.5 億美元之間。我們現在預計調整後的 EBITDA 將在 7.25 億美元至 7.75 億美元之間。我們現在預計調整後的淨收入在 1.87 億美元至 2.28 億美元之間。

One driver of this change is that we now expect an increased tax rate of 27% to 29% for the full year compared to our previous expectation in the 24% to 25% range. This increase is a result of the lower outlook for earnings before taxes as certain tax detriment items are unaffected by reduced pretax income. The rate is also affected by changes in our anticipated full year geographic mix versus prior forecasts as a larger portion of our earnings or losses are projected to arise in jurisdictions that do not provide immediate benefit for such losses and related deductions, resulting in a rate detriment.

這一變化的一個驅動因素是，我們現在預計全年稅率將提高 27% 至 29%，而我們之前的預期範圍為 24% 至 25%。這一增長是由於稅前收入前景較低，因為某些稅收減損項目不受稅前收入減少的影響。該費率還受到我們預期的全年地域組合與之前預測的變化的影響，因為我們的收入或損失的很大一部分預計將發生在不會為此類損失和相關扣除提供直接利益的司法管轄區，從而導致費率下降.

We now expect -- we continue to expect our share count to be in the range of 181 million to 183 million shares.

我們現在預計 - 我們繼續預計我們的股票數量將在 1.81 億至 1.83 億股之間。

Now I will provide some color on the temporary nature of the challenges impacting our margin in the second half of fiscal '23.

現在，我將對影響我們 23 財年下半年利潤率的挑戰的暫時性提供一些顏色。

First, in BWI. As we initially shared on April 14, we continue to expect to recover in the first half of fiscal '24 the revenue we failed to achieve this year due to our operational challenges related to the recent ERP implementation.

首先，在 BWI 中。正如我們最初在 4 月 14 日分享的那樣，由於我們與最近的 ERP 實施相關的運營挑戰，我們繼續期望在 24 財年上半年恢復我們今年未能實現的收入。

Second, also as noted on the April 14 announcement, the lost productivity in our Drug Product business, particularly in Bloomington and Brussels, was very significant. But we now expect those sites to ramp up towards previously forecasted productivity levels in the next few months as we execute on our backlog, including multiple tech transfer programs.

其次，同樣如 4 月 14 日的公告所述，我們的藥品業務的生產力損失非常嚴重，尤其是在布盧明頓和布魯塞爾。但我們現在預計，隨著我們執行積壓工作（包括多個技術轉讓計劃），這些站點將在未來幾個月內提高到先前預測的生產力水平。

Third, we have started another enterprise-wide restructuring program with a goal to double our previous commitment of $75 million to $85 million annualized cost savings. This includes costs eliminated through the completion of remediation activities in both Bloomington and Brussels. We expected the annualized impact of these activities to be roughly $100 million.

第三，我們已經啟動了另一項企業範圍的重組計劃，目標是將我們之前承諾的每年節省 7500 萬美元的成本增加一倍至 8500 萬美元。這包括通過在布盧明頓和布魯塞爾完成補救活動而消除的成本。我們預計這些活動的年化影響約為 1 億美元。

Let me reiterate again my personal regret regarding these updates. However, I would like to close our prepared remarks by reaffirming the key strengths underlying Catalent's future.

讓我再次重申我個人對這些更新的遺憾。然而，我想通過重申 Catalent 未來的關鍵優勢來結束我們準備好的發言。

First, all our issues are temporary and fixes to our operations and leadership are already underway.

首先，我們所有的問題都是暫時的，我們的運營和領導層的修復已經在進行中。

Second, we have learned many lessons that will increase our discipline and rigor going forward.

其次，我們吸取了很多教訓，這將加強我們今後的紀律和嚴謹性。

Third, we have a strong pipeline aligned with our high-quality asset base, matching the most exciting trends in our end markets, capable of delivering up to $6.5 billion in revenue with substantially lower future capital investments.

第三，我們擁有與我們高質量資產基礎相匹配的強大管道，符合我們終端市場最激動人心的趨勢，能夠以大幅降低的未來資本投資提供高達 65 億美元的收入。

Finally, over the last several months, we have continued to see a strong support from our customers, as illustrated by some of the expanded partnership I mentioned earlier in our prior calls. As a result, Catalent will continue to play a critical role in delivering some of the most consequential therapies being developed and needing commercialization.

最後，在過去的幾個月裡，我們繼續看到客戶的大力支持，正如我在之前的電話會議中提到的一些擴大的合作夥伴關係所說明的那樣。因此，康泰倫特將繼續在提供一些正在開發和需要商業化的最重要療法方面發揮關鍵作用。

This is a reset moment for Catalent, but what is unchanged is how important Catalent is to delivery of global health care, not just for vaccines, but also for the 8,000 other products we make. Patients around the world need Catalent, and we are not going to let them down.

這是康泰倫特的重置時刻，但不變的是康泰倫特對提供全球醫療保健的重要性，不僅是疫苗，還有我們生產的 8,000 種其他產品。世界各地的患者都需要 Catalent，我們不會讓他們失望。

Operator, this concludes our prepared remarks. We would like now to open the call for questions.

接線員，我們準備好的發言到此結束。我們現在想開始提問。

(Operator Instructions) And we will take our first question from Tejas Savant with Morgan Stanley.

（操作員說明）我們將與 Morgan Stanley 一起回答 Tejas Savant 的第一個問題。

Alessandro, Ricky, maybe just to kick things off. You trimmed the revenue guide by about $450 million, EBITDA by about $510 million at the midpoint. Can you just provide some of the quantitative -- the bridge essentially there in terms of perhaps the Moderna take-or-pay contract or the quality remediation cost overruns or any sort of rev rec issues related to Sarepta's drug?

亞歷山德羅，瑞奇，也許只是為了開始。您將收入指南下調了約 4.5 億美元，將 EBITDA 中值下調了約 5.1 億美元。您能否提供一些定量數據——就 Moderna 照付不議合同或質量補救成本超支或與 Sarepta 藥物相關的任何類型的 rev rec 問題而言，本質上存在的橋樑？

Tejas, this is Ricky. I'll take that question. It's a fair question. So look, the way that we think about this dynamic of the EBITDA decline being more than the revenue decline is into a couple of categories.

光輝，這是瑞奇。我會回答這個問題。這是一個公平的問題。所以看，我們認為 EBITDA 下降的動態超過收入下降的方式分為幾個類別。

So first and foremost, the delayed and missed revenues predominantly dropped through to the bottom line. The cost of the labor remains, the cost of the overhead remains, the only cost that is really eliminated is the material. So it's a high-margin drop-through on those aforementioned revenues that were delayed and missed to a future period.

因此，首先也是最重要的是，延遲和錯過的收入主要下降到底線。勞動力成本依然存在，管理費用成本依然存在，唯一真正消除的成本是材料。因此，對於那些被延遲和錯過到未來時期的上述收入來說，這是一個高利潤率的下降。

Our forecast was overly optimistic. We had aggressive timing of new business coming in, high-margin business coming in. And our plans to reduce our cost base was delayed by the necessary corrective actions that we were taking to address the regulatory actions. And with the balance sheet adjustments that we mentioned in our prepared remarks, the inventory reserves. No impact on revenue, of course, but impacting EBITDA.

我們的預測過於樂觀。我們有積極的新業務進入時機，高利潤業務進入。我們降低成本基礎的計劃因我們為應對監管行動而採取的必要糾正行動而被推遲。以及我們在準備好的評論中提到的資產負債表調整，庫存儲備。當然，對收入沒有影響，但會影響 EBITDA。

So with the combination of those factors, you get to this dynamic where the EBITDA reduction is more than that of the revenue reduction. So hopefully, that provides some color for you.

因此，結合這些因素，您將獲得 EBITDA 減少超過收入減少的動態。希望這能為您提供一些顏色。

Got it. That's helpful. And one quick follow-up on the debt covenant piece, Ricky. So is it fair to assume from your prepared remarks there that you feel very confident that you won't trip up that 6.5x debt covenant?

知道了。這很有幫助。還有一個關於債務契約的快速跟進，Ricky。那麼，從您準備好的發言中假設您非常有信心不會違反 6.5 倍的債務契約，這是否公平？

And one for you, Alessandro, big picture. I know you talked about the new sort of expansions of the contracts with Bioepis and Novo here. You've also obviously won work with Moderna, with J&J and Sarepta and the new contract as well. But there is a fair question to be had here in terms of customers worrying about management being distracted as you look to fix all of these issues across the portfolio. How have those -- how are those conversations going? And give us a flavor for how you're sort of assuring those customers that Catalent will be there for them despite all of the other noise.

還有一張給你的，亞歷山德羅，大圖。我知道你在這裡談到了與 Bioepis 和 Novo 的新合同擴展。你顯然也贏得了與 Moderna、J&J 和 Sarepta 的合作以及新合同。但是，當您希望解決整個產品組合中的所有這些問題時，客戶擔心管理層會分心，這是一個公平的問題。那些 - 那些對話進行得如何？並讓我們了解一下您如何向這些客戶保證，儘管存在所有其他噪音，Catalent 仍會為他們服務。

Tejas, I'll just address the first point of your question, which was around the debt covenant. And the answer to that is, yes, we feel very confident.

Tejas，我只想解決你問題的第一點，即圍繞債務契約。答案是，是的，我們非常有信心。

Tejas, Alessandro here. Thanks for the question, a very good one. Look, overall, as I said in my remarks, the customers remain very, very supportive of the Catalent story. Our supply situation remain very healthy.

Tejas，Alessandro 在這裡。謝謝你的問題，一個很好的問題。總的來說，正如我在發言中所說，客戶仍然非常非常支持 Catalent 的故事。我們的供應狀況仍然非常健康。

Clearly, when we enter some periods in which we are preparing for some change, we have a number of contingency plans for those changes. And so we are prepared to face potential challenges without the risk of impacting our customers.

顯然，當我們進入一些我們正在為某些變化做準備的時期時，我們有一些針對這些變化的應急計劃。因此，我們準備好面對潛在的挑戰，而不會影響我們的客戶。

So I personally spend a significant amount of my time speaking with those customers, providing them the color of those challenges. Some of them have been very, very close to what happened during the pandemic, are not surprised or shocked by what is happening in terms of how difficult sometimes it is to turn some of these operations from a period of high growth back to normal world. So I would characterize those conversations as very supportive, very understanding. And the proof is the expanded relationship that we are -- we continue to sign.

因此，我個人花費了大量時間與這些客戶交談，向他們提供這些挑戰的顏色。他們中的一些人與大流行期間發生的事情非常非常接近，他們對正在發生的事情並不感到驚訝或震驚，因為有時將其中一些業務從高增長時期恢復到正常世界是多麼困難。因此，我會將這些對話描述為非常支持、非常理解。證據就是我們正在擴大的關係——我們繼續簽署。

And we will take our next question from Jacob Johnson with Stephens.

我們將與斯蒂芬斯一起接受雅各布約翰遜的下一個問題。

I know it's probably too early to comment on FY '24. But obviously it's a focus for investors, and you guys talked a little bit about the outlook for leverage in the deck. But as we think about the $725-plus million of EBITDA in FY '23, the comments you made about leverage peaking in FY '24, the middle of the year, and then also the potential for significant approvals, there's a few puts and takes here. So can you just talk about what the key swing factors are of whether or not FY '24 EBITDA could be higher or lower next year? Like is this a trough number in FY '23?

我知道現在評論 FY '24 可能還為時過早。但顯然這是投資者關注的焦點，你們談到了套牌槓桿的前景。但是當我們考慮 23 財年 725 多萬美元的 EBITDA 時，你對槓桿率在 24 財年年中達到頂峰的評論，以及獲得重大批准的可能性，有一些看跌期權這裡。那麼，您能否談談明年 FY '24 EBITDA 會更高還是更低的關鍵搖擺因素是什麼？這是 23 財年的低谷數字嗎？

Yes, sure. Look, thanks for the question. Look, I believe that we -- it's clearly early to speak about the fiscal '24 in May, but I understand the nature and the relevance of the question you're asking.

是的，當然。看，謝謝你的問題。看，我相信我們——現在談論 5 月份的 24 財年顯然為時過早，但我理解你所問問題的性質和相關性。

Look, when you look at some of the prepared remarks we have provided today, we have tried to give some color around the temporary nature of the cost challenges. When I look at the overall picture, and notwithstanding the fact that we entered into this fiscal year with more ambitious expectations for our top line growth. But our non-COVID revenues this year, even with the current revised guidance, will still be in the mid-single-digit growth, given that the overall situation of the market is somewhat aligned.

看，當您查看我們今天提供的一些準備好的評論時，我們試圖對成本挑戰的暫時性給出一些顏色。當我審視整體情況時，儘管我們進入本財年時對我們的收入增長抱有更雄心勃勃的期望。但我們今年的非 COVID 收入，即使採用當前修訂後的指引，鑑於市場的整體情況有些一致，仍將處於中等個位數增長。

I believe that we don't have necessarily a demand here. We have a cost problem related also to execution challenges. We have provided enough -- I believe, enough color to parse out what of these costs are temporary in nature and how to think about them going forward into the next fiscal year, and so being able to carve them out from the current outlook.

我相信我們這裡不一定有需求。我們還有一個與執行挑戰相關的成本問題。我們已經提供了足夠多的——我相信，有足夠多的顏色來分析這些成本中哪些是暫時性的，以及如何考慮它們進入下一個財政年度，從而能夠將它們從當前的前景中剔除。

Okay. That's helpful. And then maybe a bigger picture question. I appreciate the $6.5 billion kind of revenue potential at Catalent. And you just talked about some of the kind of near-term cost dynamics. And I think guidance implies depressed EBITDA margin in the back half of this year.

好的。這很有幫助。然後可能是一個更大的問題。我很欣賞康泰倫特 65 億美元的收入潛力。你剛剛談到了一些短期成本動態。而且我認為指導意味著今年下半年的 EBITDA 利潤率會下降。

But as we think about the long term, I think, once upon a time, you guys were targeting 30% EBITDA margins. But say you get to $6.5 billion of revenue, what do you think is a reasonable EBITDA margin profile on that level of revenue?

但當我們考慮長期時，我認為，曾幾何時，你們的目標是 30% 的 EBITDA 利潤率。但是假設你的收入達到 65 億美元，你認為在這個收入水平上合理的 EBITDA 利潤率是多少？

So look, I believe the answer is pretty much connecting the dots, all you mentioned there. So what we are sharing is that we already have an asset base that has the potential of $6.5 billion, which means that, in many ways, our operating leverage at the moment is pretty low. So there is a lot of potential by driving higher level utilization into the assets that we have created and we have built.

所以看，我相信答案幾乎是連接點，所有你在那裡提到的。因此，我們要分享的是，我們已經擁有一個具有 65 億美元潛力的資產基礎，這意味著，在許多方面，我們目前的經營槓桿非常低。因此，通過將更高水平的利用率提高到我們創建和構建的資產中，有很大的潛力。

Clearly, when we made decisions of these investments, the biotech funding environment was different than it is today, some of the environment we were living in were a little bit different. But we believe that those trends, when you look more in the long term, are still valid. So that operating leverage that we were expecting, we continue to expect that to come back. And so we do see a significant potential of expanding our margin going forward, and surely, getting more aligned to the flight plan that we were discussing only a few months ago.

顯然，當我們做出這些投資的決定時，生物技術融資環境與今天不同，我們生活的一些環境有點不同。但我們相信，從長遠來看，這些趨勢仍然有效。因此，我們期待的經營槓桿，我們繼續期待它回來。因此，我們確實看到了擴大未來利潤率的巨大潛力，並且肯定會更加符合我們幾個月前才討論的飛行計劃。

We will take our next question from Julia Qin with JPMorgan.

我們將接受來自摩根大通的 Julia Qin 的下一個問題。

So first of all, regarding your ongoing customer conversations, Alessandro, I heard you reiterate these customer relationships remaining relatively stable here. But just curious, has there been any changes in terms of pricing or contracting terms as you work to kind of stabilize or maintain these customer relationships? And are those any potential changes reflected in your updated guidance?

所以首先，關於你正在進行的客戶對話，亞歷山德羅，我聽說你重申這些客戶關係在這裡保持相對穩定。但很好奇，在您努力穩定或維持這些客戶關係時，定價或合同條款是否有任何變化？您更新的指南中是否反映了這些潛在變化？

So look, clearly, the price environment is a very difficult answer to give -- the price environment, given the diverse portfolio that we are running, and surely in the last year, has been a key point of our negotiation with customers in terms of, when you live in such a high inflationary environment, you need to give to customers some prices to offset the inflationary environment.

因此，很明顯，價格環境是一個很難給出的答案——考慮到我們正在運行的多樣化產品組合，而且在去年肯定是這樣，價格環境一直是我們與客戶就以下方面進行談判的關鍵點，當你生活在這麼高的通脹環境下，你需要給客戶一些價格來抵消通脹環境。

In general, I would say that there has been no substantial change to our contract terms. The reality is, as we look into the future and across the different modalities, the pricing power that we have continues to be very different. In general, I believe that, in the segments where we are seeing a healthy level of demand, we have mentioned multiple times the prefilled syringes and in general fill and finish premium services, we continue to see some healthy level of pricing there.

總的來說，我會說我們的合同條款沒有實質性變化。現實是，當我們展望未來並跨越不同的模式時，我們擁有的定價權仍然非常不同。總的來說，我相信，在我們看到健康需求水平的細分市場中，我們多次提到預裝注射器和一般的填充和完成優質服務，我們繼續看到一些健康的定價水平。

So I would say that, in general, I don't see the environment changing dramatically from a pricing standpoint.

所以我想說，總的來說，從定價的角度來看，我認為環境不會發生巨大變化。

Got it. Very helpful. And then regarding the organizational changes that you mentioned earlier, could you give us more color on kind of the extent of any additional personnel departure? And whether or not they're in functions that could impact -- further impact your production capacity?

知道了。很有幫助。然後關於你之前提到的組織變化，你能否給我們更多關於任何額外人員離職程度的顏色？以及它們是否具有可能影響的功能 - 進一步影響您的生產能力？

And if you could give us a sense of where your current production capacity is compared to normal levels. And how quickly do you think you can refill those positions and get back to normal productivity?

如果你能告訴我們你目前的生產能力與正常水平相比的情況。您認為您可以多快重新填補這些職位並恢復正常的工作效率？

Yes, sure. Sure. So first part of the question. Look, I probably -- it's fastest for you to consult our website, which shows some of the changes that happen, at least at the executive level. But clearly, there were several of those.

是的，當然。當然。所以問題的第一部分。看，我可能 - 您訪問我們的網站是最快的，它顯示了一些發生的變化，至少在執行層面。但很明顯，其中有幾個。

All I can tell you is that, in this period where the job is to regain the past performances, it's very helpful to be able to tap in known leaders that have been with the companies, already have been in these positions already, and can be redeployed to reinstall what was there before. So I was very pleased to have the opportunity to have those leaders available to make the changes in a very fast fashion, going for solutions that I would define known entities with a proven track record.

我只能告訴你的是，在這個工作是重拾過去表現的時期，能夠利用曾在公司工作過、已經擔任過這些職位的知名領導者，並且可以重新部署以重新安裝之前的內容。因此，我很高興有機會讓這些領導者以非常快的方式做出改變，尋找我將定義具有良好業績記錄的知名實體的解決方案。

So I'm very confident that the changes we've done, together with the addition of Ricardo Zayas and Sridhar, which I mentioned in my remarks, we have now the team that is needed to really correct the course and reestablish the performance of the company.

所以我非常有信心，我們所做的改變，加上我在發言中提到的 Ricardo Zayas 和 Sridhar 的加入，我們現在擁有真正糾正路線和重建性能所需的團隊公司。

I would also mention that I have a lot of trust in Ricky. He knows the operational finance of the company like nobody else, and our segments and markets very well. So he's going to be very helpful in this interim period in rebuilding some of the forecasting processes that, especially in the newer parts of our business, are not as strong as they are in our legacy assets.

我還要提一下，我非常信任 Ricky。他比其他人更了解公司的運營財務，並且非常了解我們的細分市場和市場。因此，在這個過渡時期，他將非常有助於重建一些預測流程，尤其是在我們業務的較新部分，這些流程不如我們的遺留資產強大。

With regards to your question around productivity levels. The work, as I said, is already underway. We are addressing this with speed and pace. The way I would characterize this, it will take a lot of work and some time. But we are already making progress. And I can already see, notwithstanding that we're not in the position to give necessarily quarterly phasing, but I can share that I already see, in Q4, progress versus Q3.

關於您關於生產力水平的問題。正如我所說，這項工作已經在進行中。我們正在以速度和步伐解決這個問題。按照我的描述，這需要大量的工作和一些時間。但我們已經在取得進展。我已經可以看到，儘管我們無法給出必要的季度分階段，但我可以分享我已經看到的，在第四季度，相對於第三季度的進展。

Got it. That's helpful. And then last one from me. You mentioned opportunities for portfolio adjustment in your prepared remarks. Are there any preliminary thoughts you can share with us at this point? And will you be pursuing those portfolio strategy efforts simultaneously as you all work on the other issues? That's all for me.

知道了。這很有幫助。然後是我的最後一個。您在準備好的發言中提到了投資組合調整的機會。在這一點上，您有什麼初步想法可以與我們分享嗎？當你們都在處理其他問題時，你們會同時追求這些投資組合戰略嗎？這就是我的全部。

So the first part of the answer is that, as I -- this is not surprising. I've already signaled that I do believe that, at any point in time, we need to conduct assessment of our portfolio to understand what are the right assets for Catalent. And if at any point in time, we have the right order for other assets.

所以答案的第一部分是，正如我 - 這並不奇怪。我已經表示我確實相信，在任何時候，我們都需要對我們的投資組合進行評估，以了解哪些資產適合 Catalent。如果在任何時間點，我們都有其他資產的正確順序。

I do believe that, as we have built the company in the last 3 years, and arrived now to more than 50 sites, we have some significant opportunities probably in getting -- for some of the assets are thinking about better ownership, given the phase those assets are in. So it's an ongoing evaluation that we do continuously.

我確實相信，由於我們在過去 3 年裡建立了公司，現在已經到達 50 多個地點，我們可能有一些重要的機會——因為一些資產正在考慮更好的所有權，鑑於階段這些資產都在。所以這是我們不斷進行的持續評估。

Clearly, I cannot deny that the current updates that we had on the outlook surely have accelerated some of those evaluations. So we are -- the simple answer to the second part of your question is that, yes, we are doing this as we also look at improving the productivity levels at our more critical sites.

顯然，我不能否認我們當前對前景的更新肯定加速了其中一些評估。所以我們 - 對你問題第二部分的簡單回答是，是的，我們正在這樣做，因為我們也在考慮提高我們更關鍵站點的生產力水平。

We will take our next question from Dave Windley with Jefferies.

我們將與 Jefferies 一起接受 Dave Windley 的下一個問題。

A couple. I heard Ricky talk about $100 million annualized number that I think was targeted at costs and the additional restructuring. So my first question is, how much of the original $75 million to $85 million has already been harvested and is reflected in the new EBITDA guidance that you're giving today? Versus how much of what I guess would now be like $160 million target would still be targeted to take out, beyond that guidance? Above and beyond that guidance?

一對夫婦。我聽到 Ricky 談到 1 億美元的年化數字，我認為這是針對成本和額外重組的。所以我的第一個問題是，最初的 7500 萬到 8500 萬美元中有多少已經收穫並反映在您今天提供的新 EBITDA 指南中？相對於我現在猜測的 1.6 億美元目標中有多少仍將作為目標，超出該指導？超出該指導？

Yes, it's a good question, Dave. So I would say when we announced and made the cost reduction changes in November of 2022, we remain on track to deliver approximately half of that in the second half of our fiscal. The second cost-reduction exercise that we're embarking on now, we would expect to see the majority of that come through in our fiscal 2024.

是的，這是個好問題，戴夫。因此，我想說的是，當我們在 2022 年 11 月宣布並做出成本削減變化時，我們仍有望在下半財年實現約一半的成本削減。我們現在正在進行的第二次成本削減活動，我們預計將在 2024 財年看到其中的大部分。

Okay. Helpful. And then secondly, a little broader question. So kind of invoking the contract asset review, I appreciate the comments there, and the guidance and the magnitude of change.

好的。有幫助。其次，一個更廣泛的問題。如此調用合同資產審查，我很欣賞那裡的評論，以及指導和變化的幅度。

So correct me if I'm wrong, but it seems like in your saying that you've reviewed contract assets, and it seems like you're particularly pointing at Baltimore and Bloomington, the big sites, that, that would say that revenue recognition related to percentage of completion accounting through the December balance sheet date, you're saying that you're comfortable with. That certainly gives some assurance around previous rev rec.

如果我錯了，請糾正我，但在你的說法中，你似乎已經審查了合同資產，而且你似乎特別指出了大型網站巴爾的摩和布盧明頓，那就是收入確認與截至 12 月資產負債表日的完成會計百分比相關，您表示您對此感到滿意。這無疑為之前的 rev rec 提供了一些保證。

It does then say that the $510 million of EBITDA that you're taking out is essentially all second half EBITDA. That this was -- this is all kind of, from a chronological standpoint, fiscal second half of the year impact. Is there anything about that, that I should think about differently as I think about the run rate that is implied by the second half EBITDA ex these cuts?

然後它確實說你要扣除的 5.1 億美元的 EBITDA 基本上都是下半年的 EBITDA。這是 - 從時間順序的角度來看，這是對今年下半年財政的影響。關於這一點，當我考慮這些削減後的下半年 EBITDA 隱含的運行率時，我應該有什麼不同的想法嗎？

You're thinking about that correctly. But when you think about the second half, also consider what we alluded to in terms of the onetime costs that impacted the second half run rate. The full $500 million is related to the second half, it's not related to the first half. But as I said, a number of onetime nonrecurring items in that second half run rate.

您正在正確考慮這一點。但是，當您考慮下半年時，還要考慮我們提到的影響下半年運行率的一次性成本。整整5億美元與下半年有關，與上半年無關。但正如我所說，下半年運行率中有許多一次性非經常性項目。

Okay. Understood. And then, I guess, bigger picture question about the $6.5 billion, the productivity expectations. I guess, what in this review -- I understand some of this is still in flight. I guess, Alessandro, what I'm really interested in is what gives you the confidence -- given that last answer, what gives you the confidence that you can get up to or back to target margin/productivity levels in light of some factors that, if we exclude the onetime items, factors that make the margin in the second half look really, really bad? Help me understand your confidence in the long-term productivity.

好的。明白了。然後，我想，關於 65 億美元的生產力預期的更大問題。我想，這篇評論中的內容——我知道其中一些仍在進行中。我想，亞歷山德羅，我真正感興趣的是什麼讓你有信心——給出最後一個答案，什麼讓你有信心根據一些因素，你可以達到或回到目標利潤率/生產率水平，如果我們排除一次性項目，使下半年利潤率看起來真的非常糟糕的因素？幫助我了解您對長期生產力的信心。

Yes, sure, sure. So Dave, look, we need to go to the root causes to get to the confidence, right? When you look at the root causes, and this is primarily related to one of my commentary around operational COVID cliff.

是的，當然，當然。所以戴夫，看，我們需要找到根本原因才能獲得信心，對嗎？當您查看根本原因時，這主要與我對運營 COVID 懸崖的評論之一有關。

So you're talking about doubling the workforce overall at Catalent, but this was very much concentrated in very few locations, okay? So that was, of course, needed and necessary for the mission we were on. But unwinding these costs and this headcount in the middle of implementing remediation actions for [compliance] related to 483s, this is not the easiest of the tasks.

所以你說的是將 Catalent 的整體員工人數增加一倍，但這非常集中在極少數地方，好嗎？因此，對於我們所執行的任務來說，這當然是必要的。但是，在針對與 483 相關的 [合規性] 實施補救措施的過程中取消這些成本和人數，這並不是最簡單的任務。

I'm not searching for excuses here, I'm just saying that it's highly, highly complex. And surely, we have underestimated that complexity. We surely had the plans to realign the cost structures to the reality of the product mix and the portfolio, but we had to make some decisions, a trade-off, in delaying those.

我不是在這裡尋找藉口，我只是說它非常非常複雜。當然，我們低估了這種複雜性。我們當然有計劃根據產品組合和產品組合的實際情況重新調整成本結構，但我們不得不做出一些決定，權衡，推遲這些。

We don't implement ERP systems every day, and we don't do them to the extent we do it every day. This was necessary to be done. And we were mindful that we had to do it early enough before a potential approval to have time to recover if something was not going quite as expected.

我們不是天天實施ERP系統，也沒有做到天天做的程度。這是必須要做的。我們注意到，我們必須在潛在批准之前儘早完成，以便在某些事情未按預期進行時有時間恢復。

So there were decisions been made. There are things that are very, very special to this fiscal year, many first-timers. As I said, we learned a lot. But I also cognize that some of those elements will reverse as we go into the next few quarters. As I said, I already see the next -- the recent performance better than the most -- performance.

所以做出了決定。本財年有些事情非常非常特別，很多都是第一次來。正如我所說，我們學到了很多東西。但我也認識到，隨著我們進入接下來的幾個季度，其中一些因素將會逆轉。正如我所說，我已經看到了下一個 - 最近的表現比大多數 - 表現更好。

The other element that you need to think of. We have built a significant number of assets in the new modalities, which have a very low level of absorption and utilization at this point in time. Now as I said before, our expectation and focus was to fill those assets, primarily in the cell therapy space, much faster than what really happened. And that's a combination of many items. Some are environmentally related. I believe some are self-reflection we need to do on our go-to-market strategy. But the overall appeal of those areas remains. So as we -- and to be honest with you, these -- all these assets are, at the morning -- at the moment, heavily margin-dilutive to the organization.

您需要考慮的其他因素。我們在新模式中建立了大量資產，目前這些資產的吸收和利用水平非常低。正如我之前所說，我們的期望和重點是填補這些資產，主要是在細胞治療領域，比實際發生的要快得多。這是許多項目的組合。有些與環境有關。我相信有些是我們需要對我們的上市戰略進行自我反省。但這些地區的整體吸引力依然存在。因此，正如我們 - 老實說，這些 - 所有這些資產，在早上 - 目前，對組織來說嚴重稀釋了利潤。

And the latest element, looking at the portfolio considerations, is also a consideration around what are the asset at the moment nonstrategic and dilutive? And these are the assets also that we need to look at.

而最新的元素，看看投資組合的考慮，也是圍繞目前非戰略性和稀釋性資產的考慮？這些也是我們需要關注的資產。

So I hope I gave you all the elements, David, to get the same level of confidence I have, that the fundamental pricing of the business remains the same. The fundamental demand profile remains the same. The fundamental technologies we use are the same. And so all you -- when you consider all these together, we will get back the margin where it needs to be.

所以我希望我給了你所有的要素，大衛，以獲得我所擁有的相同水平的信心，即業務的基本定價保持不變。基本需求情況保持不變。我們使用的基本技術是相同的。所以你們所有人 - 當你們一起考慮所有這些時，我們將收回需要的利潤。

That's very helpful. I appreciate it. I want to ask one last quick one. And that is on the contract asset, Ricky, coming back to that. Can you -- I understand that's -- I believe that's applied to your development stage work. And could you comment then on like an aging of that from an AR standpoint? So I know you can't bill for it yet. But like how long-dated are some of those contract assets? How far back do they date?

這很有幫助。我很感激。我想問最後一個問題。這就是合同資產，瑞奇，回到那個。你能不能——我的理解是——我相信這適用於你的開發階段工作。那麼你能從 AR 的角度評論一下它的老化嗎？所以我知道你還不能為此付費。但是，比如其中一些合同資產的期限有多長？他們約會多久了？

Yes, Dave. Look, it's something that we -- obviously, we look at, we assess. But at this stage, it's not something that concerns me in terms of the aging profile of those contract asset balances. If there is ink in there greater than 1 year, it would be deemed on the balance sheet a long-term contract asset.

是的，戴夫。看，這是我們 - 顯然，我們觀察，我們評估的東西。但在現階段，就這些合同資產餘額的老化情況而言，我並不擔心。如果其中的墨水超過 1 年，則在資產負債表上將其視為長期合同資產。

But just to clarify one point. The contract asset is not just for development. As I mentioned in the prepared remarks, the large gene therapy program, which is now being treated is a contract asset as well from a development standpoint.

但只是為了澄清一點。合約資產不僅僅用於開發。正如我在準備好的發言中提到的，從發展的角度來看，目前正在接受治療的大型基因治療計劃也是一項合同資產。

So maybe I will add some other information, which we have already shared, so this is like repeating what has already been made known.

所以也許我會添加一些我們已經共享的其他信息，所以這就像重複已經公開的內容。

Clearly, as we got into these new modalities, Dave, we didn't realize how long the production process might be also due to some of the intermediate testing that is required. So there are several steps of the process. But between steps, there are very long testing times in which you essentially cannot progress the process until such a testing is completed. And that time is measured in quarters, it's not measured in months.

顯然，當我們進入這些新模式時，戴夫，我們沒有意識到由於需要進行一些中間測試，生產過程可能需要多長時間。所以這個過程有幾個步驟。但是在步驟之間，有很長的測試時間，在這樣的測試完成之前，您基本上無法推進流程。那個時間是以季度來衡量的，而不是以月來衡量的。

So of course, we're know much better now with the process ended up to be on some of these new modalities. And we are actively discussing also with our customers around how we can look at this from a contractual standpoint to avoid us having too much working capital tied with these assets as we go forward in the future.

因此，當然，隨著流程最終採用其中一些新模式，我們現在了解得更多了。我們還積極與客戶討論如何從合同的角度看待這個問題，以避免我們在未來前進時將過多的營運資金與這些資產掛鉤。

So it's very much not lost on us that it is creating an inefficiency from a working capital standpoint, and we need to find ways to address it. But that is a big contributor to this contract asset and is a big contributor also of the aging of it because you have several quarters' worth of production at any point in time that is waiting to be finalized with the last steps of the process, by design.

因此，從營運資金的角度來看，它正在造成低效率，這對我們來說並沒有丟失，我們需要找到解決這個問題的方法。但這是該合同資產的一個重要貢獻者，也是它老化的一個重要貢獻者，因為您在任何時間點都有幾個季度的生產價值等待流程的最後步驟最終確定，設計。

Dave, just to make the point also. The balance sheet review that we conducted did confirm the overall soundness of our contract assets, which included the aging profile of those balances.

戴夫，也是為了說明這一點。我們進行的資產負債表審查確實證實了我們合同資產的整體穩健性，其中包括這些餘額的賬齡情況。

We will take our next question from Paul Knight with KeyBanc.

我們將與 KeyBanc 一起接受 Paul Knight 的下一個問題。

So in effect, are you going to have to reprice in the future cell therapy projects? Do you think that was -- and also the method by which you're doing the percentage of completion recognition, does that have to be adjusted, both how you price it and the method of the recognition?

那麼實際上，您是否需要在未來的細胞治療項目中重新定價？你認為那是 - 以及你進行完成確認百分比的方法，是否必須調整，你如何定價它和確認方法？

So let's put -- if I understand where here -- your question was around the pricing of cell therapies. Or maybe -- I would say, look, probably you're asking both cell and gene therapy, so I'm going to give you a little bit more broader answer.

因此，讓我們——如果我理解這裡的話——你的問題是關於細胞療法的定價。或者也許——我會說，看，你可能在問細胞療法和基因療法，所以我會給你一個更廣泛的答案。

I don't believe that, on gene therapy, there is any pricing, significant changes into the future. I do believe that, on cell therapies, we are still finding the right process to produce these therapies in an efficient way. It's not lost on the industry that we need to make sure that these therapies are made available to a wider group of patients because they have a significant impact. So we are really working with our customers and some of our key partners from a component standpoint to try to find the solutions to have a more efficient processes. That doesn't necessarily mean only the price, but also the cost of those processes, to be addressed.

我不相信，在基因治療方面，未來會有任何定價和重大變化。我確實相信，在細胞療法方面，我們仍在尋找以有效方式生產這些療法的正確工藝。我們需要確保將這些療法提供給更廣泛的患者群體，因為它們具有重大影響，因此我們並沒有忘記這一點。因此，我們真正從組件的角度與我們的客戶和我們的一些主要合作夥伴合作，試圖找到擁有更高效流程的解決方案。這並不一定意味著要解決的只是價格，還包括這些流程的成本。

So yes, I believe that, in cell therapies over the next few years, that you're going to see changes in those regards. But I believe it's a good thing because they will allow more patients to access these therapies. And as a result, we'll have more volumes for us to manufacture.

所以是的，我相信，在未來幾年的細胞療法中，你會看到這些方面的變化。但我相信這是一件好事，因為它們會讓更多的患者獲得這些療法。因此，我們將有更多的產量供我們製造。

With regards of your second question, can you better specify the question? I want to understand exactly what you're asking.

關於你的第二個問題，能不能具體點說一下？我想確切地了解你在問什麼。

The milestones needed to achieve revenue recognition, have you learned in this process that those need to be modified?

實現收入確認所需的里程碑，您是否在這個過程中了解到需要修改的里程碑？

I don't necessarily believe that it's a matter of milestones. I believe that what we learned is that, sometimes, probably the invoicing figures along the process could be different. And so that you move faster, these value created from contract assets to AR, from AR to cash in the bank. So I believe this is the learnings. And I believe we are trying to address those learnings, attacking them from different angles. On one hand, I believe that we have opportunities to make the process much leaner, much faster, especially when it comes to the testing element of it. And the other part, I believe that we can address this also together with our customers.

我不一定認為這是一個里程碑問題。我相信我們學到的是，有時，整個過程中的發票數字可能會有所不同。為了讓你行動更快，這些價值從合同資產到 AR，從 AR 到銀行現金。所以我相信這就是教訓。而且我相信我們正在努力解決這些學習問題，從不同角度攻擊它們。一方面，我相信我們有機會使流程更精簡、更快，尤其是涉及到它的測試元素時。另一方面，我相信我們也可以與我們的客戶一起解決這個問題。

What I was then referring to the balance sheet aspect, the working capital aspect. No change from a P&L perspective from a revenue recognition.

我當時指的是資產負債表方面，即營運資金方面。從收入確認的損益角度來看沒有變化。

Okay. And then the last question is regarding Bloomington and Brussels. Did you expand beyond -- of course, you did the work to comply with the 483, but did you expand beyond the facilities in those locations as well, going above and beyond the 483 needs? And they are running now, is that correct?

好的。最後一個問題是關於布盧明頓和布魯塞爾的。你有沒有擴展——當然，你做了符合 483 的工作，但是你有沒有擴展到那些地方的設施之外，超越 483 的需求？他們現在正在運行，對嗎？

Look, I would tell you that expanding the footprint, especially in Bloomington, yes. As we mentioned many times, we're having additional lines being installed there.

看，我會告訴你擴大足跡，尤其是在布盧明頓，是的。正如我們多次提到的，我們在那里安裝了額外的線路。

If the question is in around did we go over and beyond what was necessarily in the 483? Look, every regulatory inspection is a checkpoint and an opportunity to reflect what can be improved. And Catalent has always had a very holistic approach to these situations. And so yes, we go over and beyond because we are here for the long haul. And whenever we have the opportunity, we need to make sure that we address everything at the same time, in a holistic fashion, no matter what the pain is in the short term.

如果問題出在周圍，我們是否超越了 483 中必然存在的內容？看，每一次監管檢查都是一個檢查站，也是一個反映可以改進的地方的機會。 Catalent 一直對這些情況採取非常全面的方法。所以是的，我們超越了一切，因為我們長期在這裡。只要有機會，我們就需要確保以整體的方式同時解決所有問題，無論短期內的痛苦是什麼。

And we will take our next question from Derik De Bruin with Bank of America.

我們將接受來自美國銀行的 Derik De Bruin 的下一個問題。

Just some clarifications on some things. So how much revenue from fiscal '23 is getting pushed into fiscal '24, right? And specifically, I'm curious about the gene therapy drug that's going commercial. What was that push? And we've heard there's some fairly big numbers out there on what that contribution could be to the company. I would appreciate any sort of like clarity on how to think about that, and the margin flow-through.

只是對一些事情的一些澄清。那麼 23 財年有多少收入被推到了 24 財年，對吧？具體來說，我對即將商業化的基因治療藥物很好奇。那是什麼推動？我們聽說有一些相當大的數字可以說明這種貢獻對公司的影響。我將不勝感激關於如何考慮這一點以及保證金流動的任何類似的清晰度。

Look, this is Alessandro. I appreciate your question. I really understand the reason why you're asking. I would tell you, though, that it's premature for us to make any comment for fiscal '24. It's not the time.

看，這是亞歷山德羅。我很感激你的問題。我真的明白你問的原因。不過，我會告訴你，我們現在對 24 財年發表任何評論還為時過早。現在不是時候。

Reading the question, I understand the reasons. We're going to try to give this quantification in the process soonest soon as possible. But it's a complicated equation because there is the demand, but there is also the additional scale-up of capacity you want to do to catch up on that demand, how fast you can do it, when it's going to happen? The first half of fiscal '24, second half of fiscal '24?

閱讀問題，我明白了原因。我們將嘗試盡快在流程中給出這種量化。但這是一個複雜的方程式，因為有需求，但也有你想要追趕需求的額外容量擴展，你能多快做到，什麼時候會發生？ 24 財年上半年，24 財年下半年？

I'm just not wanting -- it's not that I don't want to answer, it's just that we need some more work to make that quantification. And I can promise that as soon as we're going to have that available, we're going to share this with you guys.

我只是不想——並不是我不想回答，只是我們需要做更多的工作來進行量化。我可以保證，一旦我們準備好，我們就會與大家分享。

Right. So -- but to clarify this, you've got product that you've already made, that can supply the patients that are expected to be dosed with that drug for the next 6 to 12 months?

正確的。所以——但為了澄清這一點，你有你已經生產的產品，可以為預計在未來 6 到 12 個月內服用該藥物的患者提供產品？

Absolutely. Absolutely. We had -- if you like, a part of the reason why we have the contract asset that we have is because part of that contract asset is what we call the bright stock. Let me explain it. It's a stock that can be converted in final product with only few remaining steps of the process. So -- and you do it once some final information is available, market labels and so forth.

絕對地。絕對地。我們有——如果你願意的話，我們擁有合約資產的部分原因是因為該合約資產的一部分就是我們所說的明亮股票。讓我解釋一下。它是一種原料，只需幾個剩餘步驟即可轉化為最終產品。所以 - 一旦獲得一些最終信息、市場標籤等，您就會這樣做。

So yes, we were well aware that this ramp-up might have been more complex than others because it's new processes, it's new modalities and there is ERP implications and so forth. So we were very much mindful of building the stock ahead of the time so that we could have a period of adjustments without impacting supply. And can definitely reaffirm very, very clearly, because this is important to me, it's important to the patients out there, there is no risk to supply of any of these products.

所以，是的，我們很清楚這種升級可能比其他的更複雜，因為它是新流程、新模式以及 ERP 影響等等。因此，我們非常注意提前建立庫存，以便我們可以在不影響供應的情況下進行一段時間的調整。並且可以肯定地非常非常清楚地重申，因為這對我很重要，對那裡的患者很重要，供應任何這些產品都沒有風險。

And have you recognized revenue on that product?

您是否確認了該產品的收入？

To some percentage of completion, according to our policies, yes.

根據我們的政策，完成一定百分比，是的。

Okay. Let me try something else, then. So let's -- how much do you think of your revenue miss is tied to the biotech issues? And just because, I mean, one would argue that's not going to come back next year.

好的。那我試試別的吧那麼讓我們 - 你認為你的收入損失與生物技術問題有多大關係？只是因為，我的意思是，有人會爭辯說明年不會再出現了。

And I'm also just curious, you've had a 6% to 10% guide for the PCH business longer term. That seems to be arguably off the table now given some of the asset write-downs and things there. Can you just sort of talk about how you're thinking about that?

而且我也很好奇，您對 PCH 業務的長期指導是 6% 到 10%。考慮到一些資產減記和那裡的事情，現在這似乎可以說是不可能的。你能談談你是怎麼想的嗎？

So sure. Look, the biotech funding is clearly a situation that is still very volatile. I would say volatility there continues to be fairly high. I believe we were the first one speaking openly that, that would have been a challenge in November. But it continues to be a little bit of a challenge, especially for early-stage programs and especially new modalities. I want to stress that, in the new modalities, because of the nature of them, we have a high level of exposure to the biotech industry, and as such, to the biotech funding.

所以肯定。看，生物技術資金顯然仍然非常不穩定。我想說那裡的波動性仍然相當高。我相信我們是第一個公開表示的人，這在 11 月會是一個挑戰。但這仍然是一個挑戰，特別是對於早期項目，尤其是新模式。我想強調的是，在新模式中，由於它們的性質，我們對生物技術行業有很高的了解，因此對生物技術資金也有很高的了解。

So I believe that the first half or the second half of this calendar year will continue to be a period of volatility, and we need to continue to observe what is happening there in terms of understanding the time for recovery. There are some elements, though, that are more in our control in that regard, which is the late-stage programs which are less affected by that because they are so close to potential commercialization, which are not really affected by the funding because you're going to progress those. And I believe that on those ones, we have more visibility and we are more optimistic.

所以我相信這個日曆年的上半年或下半年將繼續是一個波動的時期，我們需要繼續觀察那裡發生的事情，以了解恢復的時間。不過，在這方面，有一些因素更受我們控制，即後期項目受此影響較小，因為它們非常接近潛在的商業化，這些項目並沒有真正受到資金的影響，因為你'我們將繼續推進這些。我相信在這些方面，我們有更多的知名度，我們也更加樂觀。

With regards of the PCH segment. When you look at what was in the script, there were 3 elements that really affected our outlook this year and made this business, which was expected to be a contributor of growth this year, to a more flattish story.

關於 PCH 段。當您查看腳本中的內容時，有 3 個因素真正影響了我們今年的前景，並使這項預計將成為今年增長貢獻者的業務變得更加平淡。

One was that we had some delayed approvals. That's the business we're in, right? Sometimes, you have a year so periods where you have the approvals altogether and periods where they just get delayed. The first half of this year was disappointing because many of these approvals were in fact delayed, and as such, the launches. All of the sudden, in the last few months, we received 10. Sometimes you don't control those events. The good news is now they've happened. And so as we look into the fiscal '24, those are going to be launches that are actually going to happen.

一是我們有一些延遲批准。這就是我們的業務，對吧？有時，您有一年的時間完全獲得批准，而這些時間只是被延遲。今年上半年令人失望，因為其中許多批准實際上被推遲了，因此，發布也被推遲了。突然之間，在過去的幾個月裡，我們收到了 10 個。有時你無法控制這些事件。好消息是現在它們已經發生了。因此，當我們研究 24 財年時，這些將是實際發生的發射。

I believe this year, we suffered from a higher-than-expected erosion of some of our portfolio in the prescription business. The erosion was expected to happen, happened a little bit faster. I believe it's now bottoming to the levels to -- for these products that will be sustained going forward. We have resolved some supply, meaning the raw material challenges for one key product we have in that segment. So during the summer, we expect to be back on the supply of those ones.

我相信今年，我們在處方業務中的一些投資組合遭受了高於預期的侵蝕。預計侵蝕會發生，發生得更快一點。我相信它現在已經觸底到 - 對於這些將持續向前發展的產品。我們已經解決了一些供應問題，這意味著我們在該領域擁有的一種關鍵產品面臨的原材料挑戰。因此，在夏季，我們預計會恢復這些產品的供應。

With regard to the consumer, I going to tell you a little bit the same response that I gave for the biotech. I believe it is still a volatile environment. We're still monitoring it. We continue to convert the portfolio to larger, bigger, more diverse customers. But that's an environment where we continue to observe, in the next 6 month cycles, how it goes. I hope this color helps you.

關於消費者，我要告訴你一些與我對生物技術相同的回答。我相信這仍然是一個不穩定的環境。我們仍在監視它。我們繼續將產品組合轉變為更大、更大、更多樣化的客戶。但這是我們在接下來的 6 個月週期中繼續觀察的環境。我希望這個顏色對你有幫助。

It does. And just one final one, just to be clear. You don't -- do you need any restatements, do you think, beyond fiscal '22? Basically, just if you go back and you look at the pre-COVID numbers before you started adding those capacity, are those numbers safe from what you've reported?

確實如此。最後一個，只是為了清楚一點。你不需要——你認為在 22 財年之後需要任何重述嗎？基本上，如果您在開始增加這些容量之前回頭看看 COVID 之前的數字，這些數字與您報告的內容相比是否安全？

I would -- look, I would say that we just continue to assess, address the effect of these adjustments that we discussed earlier in our previously issued financial statements. When the assessment is complete, we'll be back and fully explain to our investors these prior period changes and their effects on our financial statements.

我會 - 看，我會說我們只是繼續評估，解決我們早些時候在我們之前發布的財務報表中討論的這些調整的影響。評估完成後，我們將返回並向我們的投資者充分解釋這些前期變化及其對我們財務報表的影響。

And we will take our next question from Luke Sergott with Barclays.

我們將從巴克萊銀行的 Luke Sergott 那裡回答下一個問題。

Great. So before the operational challenges, you guys were doing about $300 million, plus or minus, in EBITDA per quarter. And so like outside of the next few quarters, and you're clearly a bit below those -- that level. But when do you guys expect to -- or when can we think about -- reasonably think about when that will get back to those types of levels? And like is that back half of '24? Is it more going to be like a '25 issue?

偉大的。因此，在面臨運營挑戰之前，你們每個季度的 EBITDA 約為 3 億美元，上下浮動。所以就像在接下來的幾個季度之外，你明顯低於那些——那個水平。但是你們什麼時候期望——或者我們什麼時候可以考慮——合理地考慮什麼時候會回到那些類型的水平？就像 24 年的後半部分一樣？它更像是一個'25問題嗎？

Look, I believe that, as I said, that this would require some time and some work. I have confidence that we're going to get back there. It also depends on the top line, so there are many variables attached to it. And of course, as you know, we have a pretty consequential events on the horizon, in the next few weeks. So I believe it's hard to make a prediction. But I believe that, if you assume calendar '24, you're not far from where we expect to be.

看，我相信，正如我所說，這需要一些時間和一些工作。我有信心我們會回到那裡。它還取決於頂線，因此它附帶有很多變數。當然，如您所知，在接下來的幾週內，我們將發生相當重要的事件。所以我認為很難做出預測。但我相信，如果你假設 24 年日曆，你離我們預期的地方不遠了。

Okay. Great. And then I guess on the approval. Can you -- for the gene therapy. I mean, you guys were scaling up to, I think it was like a 16 or 18 suites. Can you update us on what that manufacturing capacity -- do you guys need to build out additional suites? Because it's clearly taking more of the materials and inventory to make the drug than what was earlier anticipated.

好的。偉大的。然後我猜是關於批准的。你能——用於基因治療嗎？我的意思是，你們正在擴大規模，我認為這就像 16 或 18 間套房。你能告訴我們製造能力的最新情況——你們需要建造額外的套房嗎？因為製造這種藥物顯然需要比早先預期更多的材料和庫存。

Look, as we said, the BWI facility, we built that facility with a lot of capacity, and we believe that we are creating capacity for our current needs. But this facility can continue to serve the demand in gene therapy for years to come after the expansions that we have done. So there is a lot of capacity available there. We feel very comfortable. It's a premium facility, it's commercially approved. This is very recently to more successful PAI inspections. It's still a jewel in the crown of Catalent, notwithstanding some of the short-term challenges we discussed with our ERP implementation. Very, very pleased with that facility and very optimistic about the future.

看，正如我們所說，BWI 設施，我們建造的設施具有很大的容量，我們相信我們正在為我們當前的需求創造容量。但是，在我們完成擴展之後，該設施可以在未來幾年繼續滿足基因治療的需求。所以那裡有很多可用的容量。我們感覺很舒服。這是一個高級設施，已獲得商業批准。這是最近更成功的 PAI 檢查。它仍然是 Catalent 皇冠上的一顆明珠，儘管我們在 ERP 實施中討論了一些短期挑戰。對該設施非常非常滿意，並對未來非常樂觀。

Okay. And then lastly here on the -- sticking with the percentage of completion. How do you plan to do that through actually after the drug is approved, assuming it does get approved? I mean, how does that work?

好的。最後，堅持完成百分比。假設藥物確實獲得批准，您打算如何在藥物獲得批准後真正做到這一點？我的意思是，它是如何工作的？

Yes. So we've concluded on the accountant with regard to that product. It will be continued on a percentage of completion basis. But as we shared during our prepared remarks, for such a complex agreement, we are looking at other contract terms that could prospectively modify our accounting for that product going forward.

是的。因此，我們已經就該產品的會計師得出結論。它將根據完成的百分比繼續進行。但正如我們在準備好的評論中分享的那樣，對於如此復雜的協議，我們正在研究其他合同條款，這些條款可能會在未來修改我們對該產品的會計處理。

Yes. I mean, it gets approved, it's commercialized, that's no longer development, right? So it'd have to be recognized in batch commercialization, right?

是的。我的意思是，它獲得批准，它被商業化，這不再是開發，對吧？所以它必須在批量商業化中得到認可，對嗎？

No, no, that's the point, is it will be -- we will continue to recognize it, if it is approved and it's a commercial product, on a percentage of completion basis.

不，不，這就是重點，如果它獲得批准並且它是商業產品，我們將繼續承認它，以完成的百分比為基礎。

We will take our next question from Jack Meehan with Nephron Research.

我們將接受 Nephron Research 的 Jack Meehan 的下一個問題。

So my question is simple. Can you grow EBITDA in 2024? Based on the transitory impacts you've talked about, can you just confirm, 2023, what you've laid out, is this going to be the trough?

所以我的問題很簡單。您能否在 2024 年增加 EBITDA？根據你所說的暫時性影響，你能否確認，2023 年，你所規劃的，這將是谷底嗎？

So look, clearly, this question requires some -- you make these answers based on assumptions. So based on some assumptions of these, I would say that is a credible expectation. And some key assumption is also regarding some expected approvals in the next few months.

所以看，很明顯，這個問題需要一些——你根據假設做出這些答案。因此，基於對這些的一些假設，我會說這是一個可信的期望。一些關鍵假設也與未來幾個月的一些預期批准有關。

Okay. And then I believe I heard you mentioned the COVID forecast down 50% year-over-year. So it sounds like you maintained it at over $600 million for the fiscal year. Could you confirm that? And what's embedded for the second half of '23?

好的。然後我相信我聽說你提到 COVID 預測同比下降 50%。所以聽起來你在本財政年度將其維持在 6 億美元以上。你能證實嗎？ 23 年下半年嵌入了什麼？

It's about right. Yes. We pretty much expect it to be the number. Maybe a little bit different in the phasing, but yes.

這是對的。是的。我們非常希望它是這個數字。也許在階段上有點不同，但是是的。

Yes. Yes, we -- no change to our private -- previous estimates around that number, a little more than $600 million.

是的。是的，我們——我們的私人部門沒有改變——之前對這個數字的估計，略多於 6 億美元。

Great. And one final. What was the $26 million impact in the fourth quarter of '22 you called out?

偉大的。還有一場決賽。你所說的 22 年第四季度的 2600 萬美元影響是什麼？

So yes, as a result of the balance sheet review that we are still ongoing, one of the reasons why we are late in our Q3 financial statements, is it did lead -- the review did lead to some accounting adjustments. And one that we shared here today was to correct a $26 million revenue error related to fiscal 2022. But overall, I'm very pleased with the pace, the depth, the overall quality of the review that we're doing to make sure that we don't leave any stone unturned.

所以是的，由於我們仍在進行資產負債表審查，這是我們第三季度財務報表遲交的原因之一，它確實導致了 - 審查確實導致了一些會計調整。我們今天在這里分享的一個是糾正與 2022 財年相關的 2600 萬美元的收入錯誤。但總的來說，我對我們為確保我們不遺餘力。

And we will take our next question from Max Smock with William Blair.

我們將與 William Blair 一起接受 Max Smock 的下一個問題。

Just wanted to follow up on an earlier question, the point from the deck around net leverage peaking in the middle of fiscal 2024. I know you said it's a little too early to give a guide on next year, but can you just confirm that net leverage peaking in the middle of fiscal 2024 means adjusted EBITDA in the first half of next year will be down year-over-year?

只是想跟進一個較早的問題，關於淨槓桿率在 2024 財年中期達到頂峰的觀點。我知道你說現在給出明年的指導還為時過早，但你能否確認淨槓桿率槓桿率在 2024 財年中期達到頂峰意味著明年上半年調整後的 EBITDA 將同比下降？

Again, we have not completed a full assessment of fiscal '24. Myself, I'm getting up to speed here on all financial matters at Catalent. My focus has been around Q3 financial reporting commitments. And at this stage, we don't have a fully built-out FY '24. The...

同樣，我們還沒有完成對 24 財年的全面評估。就我個人而言，我正在加速了解 Catalent 的所有財務事宜。我的重點是第三季度的財務報告承諾。在這個階段，我們還沒有完全建成的 FY '24。這...

Yes, I would say, look, that being said, our ratio is always calculating on a LTM basis, right? So there is not only -- it's not necessarily only the next couple of quarters, it always looks at 4 quarters back. So there is an averaging factor there.

是的，我會說，看，話雖這麼說，我們的比率總是在 LTM 的基礎上計算，對嗎？所以不僅 - 它不一定只是接下來的幾個季度，它總是回顧 4 個季度。所以那裡有一個平均因素。

Okay. Got it. Maybe just a couple of quick ones on Sarepta. There was a lot of focus last week during their AdComm on the ratio of empty capsids. Can you just discuss what's going on there? Why you changed the manufacturing process to one that has higher empty capsids and did not add steps to address this issue? And then whether or not there could be some CMC issues moving forward as a result, even though the FDA has already completed its inspection at your BWI facilities?

好的。知道了。也許只是 Sarepta 上的幾個快速的。上週在他們的 AdComm 期間，空衣殼的比例受到了很多關注。你能談談那裡發生了什麼嗎？為什麼你們將製造工藝更改為具有更高空衣殼的工藝並且沒有添加解決此問題的步驟？然後，即使 FDA 已經完成了對您的 BWI 設施的檢查，是否還會有一些 CMC 問題向前推進？

First of all, look, there is not necessarily a change of the process. Sometimes, when you develop drugs, there are processes that are suitable for the early clinical stage and they are not necessarily suitable for larger clinical production -- commercial production. So -- and so this sometimes use different technologies with this process.

首先看，不一定是流程的變化。有時，當你開發藥物時，有些工藝適合早期臨床階段，但不一定適合更大規模的臨床生產——商業生產。所以 - 所以這有時會在此過程中使用不同的技術。

I don't believe that there was any comment around these. It's more in and around it's in the nature of what we do. Bench scale is not same on industrial scale. It is an industrial, what we use here. It is, I mean, and industry standard process that is used for this type of therapy, used in many other programs. And I believe the data continue to be pretty sound also with regards of the use of this process.

我認為沒有關於這些的任何評論。它更多地體現在我們所做的事情的本質上。工作台規模與工業規模不同。這是一個工業，我們在這裡使用。我的意思是，用於此類治療的行業標準流程用於許多其他程序。而且我相信關於使用此過程的數據仍然非常可靠。

That being said, we are in an industry where we always look at opportunities to further enhancing processes. But as it stands today, this is an industry standard, it's more suitable for the large commercial volumes, and the data are supporting the use of these products.

話雖這麼說，我們所處的行業總是尋找進一步改進流程的機會。但就目前來看，這是一個行業標準，更適合商業體量大的情況，有數據支持這些產品的使用。

Okay. Got it. Maybe just one final one for me on Sarepta. You mentioned already having product for initial dosing the patients. I understand that SRP-9001 is a big opportunity moving forward. But how should we think about the potential revenue in fiscal 2024? Given Sarepta said during the AdComm that it only expects to treat about 100 patients in the first 6 months post launch? Does this mean that we could actually see a step down in revenue from this program in fiscal 2024, especially considering Thermo could be up and running by then?

好的。知道了。也許只是我在 Sarepta 上的最後一首。你提到已經有了用於對患者進行初始給藥的產品。我知道 SRP-9001 是一個向前發展的巨大機遇。但是我們應該如何考慮 2024 財年的潛在收入呢？鑑於 Sarepta 在 AdComm 期間表示，它預計在發布後的前 6 個月內只治療大約 100 名患者？這是否意味著我們實際上可以在 2024 財年看到該計劃的收入下降，特別是考慮到 Thermo 屆時可能會啟動並運行？

So look, if -- on the basis that the product is approved as -- or achieved an accelerated approval, I want to be more specific. Surely, I do not expect that there would be a reduction.

所以看，如果——在產品被批准為——或獲得加速批准的基礎上，我想更具體一點。當然，我不認為會有減少。

We will take our next question from John Sourbeer, UBS.

我們將從瑞銀的 John Sourbeer 那裡回答下一個問題。

I Just wanted to dig in a little bit deeper on some of the emerging biotech that you mentioned earlier. I guess some of your peers have provided what percentage of revenue is they're exposed. So would you be willing to provide that? And maybe even ex Sarepta and gene therapy, what does that look like for your customer base?

我只是想更深入地了解您之前提到的一些新興生物技術。我猜你的一些同行已經提供了他們暴露的收入百分比。那麼你願意提供嗎？甚至可能是 ex Sarepta 和基因療法，這對您的客戶群來說是什麼樣的？

And then you mentioned that there were no customer cancellations. But assuming that some of these companies have no capital, do you think that maybe these assumptions here are a little bit more too optimistic, and that there could be cancellations here moving into next year?

然後你提到沒有客戶取消。但假設其中一些公司沒有資本，您是否認為這裡的這些假設可能有點過於樂觀，並且明年可能會取消？

Yes. I mean, when I -- of course, whenever I make a commentary, I'm making commentary around sizable, notable cancellations in our business. Because we are in the clinical world, in modalities that there are, all the time, cancellations, just because of the nature of the business. That some of -- most of these programs do fail as they go through the clinic. So I just want to caveat that I was referring to large, notable commercial supply agreements that were potentially being canceled and can have a material impact on the company.

是的。我的意思是，當我 - 當然，每當我發表評論時，我都會圍繞我們業務中相當大的，顯著的取消發表評論。因為我們身處臨床世界，所以總是因為業務的性質而取消。其中一些 - 大多數這些程序在通過診所時確實失敗了。所以我只是想提醒一下，我指的是可能被取消並可能對公司產生重大影響的大型、著名的商業供應協議。

With regards of your comment around optimism, I believe we've been pretty humble and open here in saying that, yes, we've been optimistic. I don't believe necessarily on the rate of cancellations. I believe we've been optimistic around the amount of assets which would have been entering the clinic or progressing through the clinic ink in these last, call it, 9 months. And the pace at which this was happening now is very, very different from what it was in 2021 and 2022 -- I would say mid-2020 to mid-2022. There's been a sharp correction, what we've seen from our observation standpoint. But the science is still there, and the potential -- the unmet need for patients is still there. And the efficacy and safety profiles of this is still there. So these are all elements that will bring this back at some point.

關於您對樂觀的評論，我相信我們一直非常謙虛和開放地說，是的，我們一直很樂觀。我不一定相信取消率。我相信我們對在過去 9 個月內進入診所或通過診所墨水取得進展的資產數量持樂觀態度。現在發生這種情況的速度與 2021 年和 2022 年非常非常不同——我想說是 2020 年年中到 2022 年年中。從我們的觀察角度來看，我們已經看到了急劇的修正。但科學仍然存在，而且潛力——未滿足的患者需求仍然存在。而且它的功效和安全性仍然存在。所以這些都是將在某個時候恢復的元素。

So yes, we were optimistic. Yes, now we have learned and we have a more realistic outlook. But yes, we continue to be bullish about the long-term prospects of these modalities.

所以是的，我們很樂觀。是的，現在我們已經了解了，我們有了更現實的看法。但是，是的，我們繼續看好這些方式的長期前景。

Got it. And then I guess just on the Brussels facility. The previous press release didn't provide a time line there. I just want to confirm just the time lines on when you think that these productivity issues would be resolved.

知道了。然後我想就在布魯塞爾工廠。之前的新聞稿沒有提供時間表。我只想確認您認為這些生產力問題何時會得到解決的時間表。

And then just from a high level, can you remind us on the overview there? What percentage of that facility is dedicated to Novo and Wegovy?

然後從高層次上，你能提醒我們那裡的概述嗎？該設施中有多少百分比專門用於 Novo 和 Wegovy？

So on the last question, I cannot give you that information. It's just simply that we're not authorized to share without our customers. So I can tell you that, for Brussels, we have now -- the facility is now finally fully up to running after some periods of challenges. And especially when you restart from these long periods, it's complicated to reach the efficiency levels that you experienced before.

所以關於最後一個問題，我不能給你那個信息。很簡單，我們無權在沒有客戶的情況下共享。所以我可以告訴你，對於布魯塞爾，我們現在 - 在經歷了一些挑戰之後，該設施現在終於完全可以運行了。尤其是當您從這麼長的時間段重新開始時，要達到您之前體驗過的效率水平是很複雜的。

I would say, in total honesty, it's still a while. We are now at the full absorption, still a work in progress. I still believe that, in Brussels, we're going to have to do more work and will require some more time, to be honest with you. But the good news there is that we have all the demand that we want because we have to recover on a lot of backlog.

我會說，老實說，還有一段時間。我們現在正處於完全吸收狀態，仍在進行中。老實說，我仍然相信，在布魯塞爾，我們將不得不做更多的工作，需要更多的時間。但好消息是，我們擁有所有想要的需求，因為我們必須恢復大量積壓。

So the absorption and the utilization is not going to be a problem, it's just recovering the manufacturing consistency that we had before, and we are making very good progress in that direction. But this is something that just doesn't happen overnight when you experience the challenges that we have experienced.

所以吸收和利用不會成為問題，它只是恢復了我們以前的製造一致性，我們在這個方向上取得了很好的進展。但當您遇到我們所經歷的挑戰時，這不會在一夜之間發生。

And we will take our next question from Sean Dodge with RBC Capital Markets.

我們將接受 RBC Capital Markets 的 Sean Dodge 的下一個問題。

Alessandro, you said with the Bloomington tech transfers, the couple that you've won there and working to launch, they're a little more complex and taking longer than expected. Did I hear correctly, those are done now and up and running? And then as we think about how meaningful those are, could you, I don't know, maybe compare the size of those relative to the COVID work in Bloomington that you're working to backfill?

亞歷山德羅，你說過布盧明頓技術轉讓，你在那裡贏得併努力啟動的夫婦，它們有點複雜，花費的時間比預期的要長。我沒聽錯嗎，現在已經完成並開始運行了？然後，當我們考慮這些有多大意義時，我不知道，你能否比較那些與你正在努力回填的布盧明頓 COVID 工作相關的規模？

Sure. That's a great question. So first of all, I believe that the technical challenges and hurdles that we experienced that caused us to experience delay to the final steps of the validation of this program has been overcome now. So now it's completing the last steps and waiting for the regulatory timing that is required to get ourselves in the position to full commercial production. So as we said in our remarks, we expect now this to be our second calendar year '23 impact in terms of these [launch].

當然。這是一個很好的問題。因此，首先，我相信我們所經歷的技術挑戰和障礙導致我們在驗證該程序的最後步驟時遇到延遲，現在已經克服了。因此，現在它正在完成最後的步驟，並等待使我們能夠全面商業化生產所需的監管時間。因此，正如我們在評論中所說，我們現在預計這將是我們在這些 [launch] 方面的第二個日曆年 '23 影響。

These are meaningful products. So I can tell you that, at this point in time, my biggest concern is to have enough capacity, more than demand. We're trying to make an effort of freeing up and installing additional capacity there so that we can support what we envision to be very high-demand products because the end market is very strong and, at the moment, is not fully satisfied.

這些都是有意義的產品。所以我可以告訴你，在這個時候，我最關心的是有足夠的能力，而不是需求。我們正努力在那裡釋放和安裝額外的容量，以便我們能夠支持我們設想的高需求產品，因為終端市場非常強大，目前還沒有完全滿足。

It's difficult to make a parallel to the COVID times because these are very different products. I can tell you, from a profitability standpoint, we are aligned in terms of the margin. Clearly, you need to understand that there is no product in the world that will ever be produced in 1 billion doses in 18 months. That is never going to be beaten terms of what we've done in Bloomington. So I believe that was a little bit of a unique situation.

很難與 COVID 時間平行，因為它們是非常不同的產品。我可以告訴你，從盈利能力的角度來看，我們在利潤率方面是一致的。顯然，您需要了解，世界上沒有任何產品可以在 18 個月內生產出 10 億劑。就我們在布盧明頓所做的事情而言，這永遠不會被擊敗。所以我認為那是一種獨特的情況。

But net of that, which we have now already washed out of our numbers, it's a very healthy portfolio that we have down there.

但除此之外，我們現在已經從我們的數字中剔除了它，這是我們在那裡擁有的非常健康的投資組合。

Okay. Great. And then you pointed out that you all continue to win new business, including an expansion with Novo. When was that expansion signed? And maybe is there any more color you can provide there? Is this kind of involving you working with them on more products? Or is this expanding what you're doing with them beyond the Brussels facility?

好的。偉大的。然後你指出你們都在繼續贏得新業務，包括與 Novo 的擴張。擴建是什麼時候簽署的？也許您可以在那裡提供更多顏色？這種涉及您與他們合作開發更多產品嗎？或者這是將您與他們一起做的事情擴展到布魯塞爾工廠之外？

Yes, yes. Sure, sure. Look, it's clearly, as we bring the new assets online, we give -- and these assets are in high demand, as you can expect. We said it repeatedly and also some of our competitors are giving same information, right?

是的是的。一定一定。看，很明顯，當我們將新資產上線時，我們給予——這些資產的需求量很大，正如你所預料的那樣。我們反复說過，我們的一些競爭對手也提供了同樣的信息，對嗎？

So when you look at this, clearly, when you have these new assets coming online, the first thing you do, you offer them to your existing partners with which you have a very healthy, established and fruitful discussion. And many times -- more times than not in the recent months, those customers have picked up on the offer to go in some of the sites and to go to some other capacity and bigger capacity. So I believe that's very, very exciting for us. The fact that our customers continue to give us confidence and continue to want serve from us, it's probably the best thing that can happen to us.

因此，當您清楚地看到這一點時，當您將這些新資產上線時，您做的第一件事就是將它們提供給您現有的合作夥伴，與您進行非常健康、成熟和富有成果的討論。很多次——在最近幾個月裡，這些客戶多次接受了進入某些站點並進入其他容量和更大容量的提議。所以我相信這對我們來說非常非常令人興奮。事實上，我們的客戶繼續給我們信心並繼續希望我們提供服務，這可能是發生在我們身上的最好的事情。

And we will take our final question from Justin Bowers with Deutsche Bank.

我們將接受德意志銀行賈斯汀鮑爾斯的最後一個問題。

Just have 2 sort of broader questions, and then I'll follow up offline with the rest. But with respect to gene therapy, and I'm just piecing together a few comments from the call, but you did say that you have additional suites coming online through the end of the year. So I'm curious if that's referring to BWI, too, and if you mean through the end of this calendar year.

只需提出 2 個更廣泛的問題，然後我會離線跟進其餘問題。但關於基因治療，我只是把電話中的一些評論拼湊在一起，但你確實說過你有額外的套件在今年年底上線。所以我很好奇這是否也指的是 BWI，如果你的意思是到這個日曆年結束。

And then the second part of that would be, you had some comments around 7 quarters of production waiting to be released. So is that reflected in the -- sort of in the contract asset on the balance sheet? And I'll pause there until the second one.

然後是第二部分，您對等待發布的 7 個季度的製作發表了一些評論。那麼，這是否反映在資產負債表上的合同資產中？我會在那裡暫停，直到第二個。

Mr. Maselli, are you there?

Maselli 先生，你在嗎？

(technical difficulty)

（技術難度）

And ladies and gentlemen, thank you for your patience. We do have our speakers reconnected.

女士們先生們，謝謝你們的耐心等待。我們確實重新連接了揚聲器。

Sorry, everyone. We had an outage here at our location, so we are reconnecting from mobile. So can you please ask again, the last question?

對不起，大家。我們所在的位置出現故障，因此我們正在通過移動設備重新連接。那麼你能再問一遍，最後一個問題嗎？

Yes, sure. So it's -- 2 questions, 1 related to gene therapy and then 1 just related to the guide down. With respect to gene therapy, you talked about bringing new capacity online. I'm just curious if the timing, is that through the end of this year? And is that related to BWI, and all 8 suites that you've sort of talked about before?

是的，當然。所以它是 - 2 個問題，1 個與基因治療相關，然後 1 個僅與指南相關。關於基因治療，您談到了將新的能力帶到網上。我只是好奇時間，是到今年年底嗎？這與 BWI 以及您之前談到的所有 8 個套件有關嗎？

Part 2 of that is you also said that you have sort of 7 quarters of production, I believe, waiting to be released in the contract assets. I don't want to paraphrase, but I just want to clarify that, that is what you said. So that's related to gene therapy. And then I'll come back with the second one on the guide.

第 2 部分是你還說你有 7 個季度的生產，我相信，等待在合同資產中發布。我不想解釋，但我只想澄清一下，這就是你所說的。所以這與基因治療有關。然後我會帶著指南中的第二個回來。

Let me address the last one. I didn't say several quarters, I said a few. It means I just was saying that if it's not a contract -- the process length is not 3 months. It's more, it's longer than that. It depends on a few things. But you need to think about the process length from the start to finish somewhere in the several months type of time frame. And we are working actively to reduce that.

讓我談談最後一個。我沒說幾個季度，我說幾個。這意味著我只是說如果它不是合同——流程長度不是 3 個月。它更多，它比那更長。這取決於幾件事。但是您需要考慮幾個月類型的時間範圍內從開始到完成某處的過程長度。我們正在積極努力減少這種情況。

With regards of the suites, yes, is BWI the ones we were referring to? You don't have to think about this as a binary event, [I told you at the start] that you have all these suites. So these suites have the ability to come online progressively in synced couples, call it, so because the facility allows that to happen. So we have 2, then another 2, another 2. And over the next few months, we're going to bring online at this additional capacity.

關於套房，是的，我們指的是 BWI 嗎？您不必將此視為二元事件，[我在開始時告訴過您]您擁有所有這些套件。所以這些套房有能力在同步的夫婦中逐步上線，稱之為，因為設施允許這種情況發生。所以我們有 2 個，然後是另外 2 個，另外 2 個。在接下來的幾個月裡，我們將以這個額外的容量上線。

Understand, and that makes sense. And was that one of the inspections -- were one of the inspections related to those suites as well?

明白了，說得通。那是其中一項檢查 - 也是與這些套房相關的檢查之一嗎？

And then just the other parts of that in terms of the contract terms. Since you're still doing it on percentage of completions, it sounds like the amendment that you're looking for is maybe on the invoicing. Is that fair?

然後是合同條款中的其他部分。由於您仍在按完成百分比進行操作，因此聽起來您正在尋找的修正案可能在發票上。這公平嗎？

So the first part of the question, look, the inspection is never by suite. You inspect the whole facility. And for us, from a regulated standpoint, BWI and [BW2] belongs to the same campus. So you need to look at this. When you get inspected, the inspection is relevant to the entire campus. So that's the answer to your first part of the question.

所以問題的第一部分，看，檢查從來不是按套房進行的。你檢查整個設施。而對我們來說，從監管的角度來看，BWI 和 [BW2] 屬於同一個校區。所以你需要看看這個。當你被檢查時，檢查是與整個校園有關的。這就是問題第一部分的答案。

So very, very pleased that those inspections were successful because, again, it's an impact that these are inspections related to that, but they have an impact on the overall facility. So very, very pleased with that outcome.

非常非常高興這些檢查取得了成功，因為這些檢查與此相關，但它們會對整個設施產生影響。對這個結果非常非常滿意。

And with regards of the terms, look, probably a little bit of a clarification here. Ricky was referring to some other terms of the contract with regards of our revenue recognition mechanisms there beyond the percentage of completion. I do believe that we have an opportunity to -- and we are already making progress in terms of setting the different milestones for invoicing of these contract assets going forward, that we're going to continue to work against these objectives.

關於術語，看，這裡可能有一點澄清。 Ricky 指的是合同中關於我們的收入確認機制的一些其他條款，超出了完成百分比。我確實相信我們有機會——而且我們已經在為這些合同資產開具發票設定不同的里程碑方面取得了進展，我們將繼續朝著這些目標努力。

Okay. And then just quickly, on the -- on the change in the guide, it sounded like, of the $500 million, that $400 million was related to forecasting and then the other $100 million was related to sort of the onetimers. I just want to clarify that. And then, of the onetimers, you guys did spike out sort of $55 million in inventory markdown. Is that one of those onetimers? And is that running through the P&L with the new guidance?

好的。然後很快，關於指南的變化，聽起來像是在 5 億美元中，4 億美元與預測有關，然後另外 1 億美元與某種一次性產品有關。我只想澄清一下。然後，在一次性產品中，你們確實在庫存降價方面飆升了 5500 萬美元。那是那些曾經的人之一嗎？那是在新的指導下貫穿損益表嗎？

Yes, I would -- if I take that, Alessandro. I would say that you're right about the $55 million in terms of being the -- one of the onetimers. But after that one-timer, I would estimate it to be roughly split equally, 50-50, between the forecasting challenges that Alessandro referred to and the operational, and productivity challenges being the second issue for the quarter and on our guidance.

是的，我願意——如果我接受的話，亞歷山德羅。我會說你是對的 5500 萬美元作為 - 一個曾經的人。但在那一次之後，我估計它在亞歷山德羅提到的預測挑戰和運營以及生產力挑戰之間大致平均分配 50-50，這是本季度的第二個問題和我們的指導。

Yes. And I would add that when you think about onetimer, Ricky refers to onetimer, if you like, more from a financial accounting standpoint. But even also in the execution challenges, there are issues that we deem temporary in nature which we are addressing. We don't believe that they will affect long term the business performance from a profitability standpoint.

是的。我想補充一點，當你想到 onetimer 時，Ricky 指的是 onetimer，如果你願意的話，更多是從財務會計的角度來看。但即使在執行挑戰中，也存在我們認為暫時性的問題，我們正在解決這些問題。從盈利能力的角度來看，我們認為它們不會影響長期的業務績效。

So -- yes?

所以——是嗎？

I apologize. Ladies and gentlemen, that concludes the question-and-answer portion of today's call. I will now turn the call back to Mr. Alessandro Maselli for closing remarks.

我道歉。女士們，先生們，今天電話會議的問答部分到此結束。我現在將把電話轉回給 Alessandro Maselli 先生作結束語。

Thank you. Thank you, everyone, for taking the time to join our call and your continued support of Catalent.

謝謝。感謝大家抽出時間加入我們的電話會議，感謝您對 Catalent 的持續支持。

Ladies and gentlemen, that concludes today's conference call, and we thank you for your participation. You may now disconnect.

女士們，先生們，今天的電話會議到此結束，我們感謝您的參與。您現在可以斷開連接。