Catalent Inc (CTLT) 2023 Q1 法說會逐字稿

Hello, everyone, and welcome to the Catalent, Inc. First Quarter Fiscal Year 2023 Earnings Conference Call. My name is Daisy, and I'll be coordinating your call today. (Operator Instructions)

大家好，歡迎參加 Catalent, Inc. 2023 財年第一季度收益電話會議。我的名字是黛西，今天我會協調你的電話。 （操作員說明）

I would now like to hand the call over to your host, Paul Surdez, Vice President of Investor Relations, to begin. So Paul, please go ahead. .

我現在想將電話轉交給您的主持人，投資者關係副總裁 Paul Surdez，開始。所以保羅，請繼續。 .

Thanks, Daisy. Good morning, everyone, and thank you all for joining us today to review Catalent's First Quarter 2023 Financial Results. Joining me on the call today are Alessandro Maselli, President and Chief Executive Officer; and Tom Castellano, Senior Vice President and Chief Financial Officer.

謝謝，黛西。大家早上好，感謝大家今天加入我們，回顧 Catalent 2023 年第一季度的財務業績。今天和我一起參加電話會議的是總裁兼首席執行官 Alessandro Maselli；以及高級副總裁兼首席財務官 Tom Castellano。

Please see our agenda for today's call on Slide 2 of our supplemental presentation, which is available on our Investor Relations website at investor.catalent.com.

請在我們的補充演示文稿的幻燈片 2 上查看我們今天的電話會議議程，該幻燈片可在我們的投資者關係網站investor.catalent.com 上找到。

During our call today, management will make forward-looking statements and refer to GAAP and non-GAAP financial measures. It is possible that actual results could differ from management's expectations. We refer you to Slide 3 for more detail on forward-looking statements, slides 4 and 5 discuss Catalent's use of non-GAAP financial measures and our just issued earnings release provides reconciliations to the most directly comparable GAAP 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 GAAP 和非 GAAP 財務指標。實際結果可能與管理層的預期不同。我們向您推薦幻燈片 3 以了解有關前瞻性陳述的更多詳細信息，幻燈片 4 和 5 討論了 Catalent 使用非 GAAP 財務指標，我們剛剛發布的收益發布提供了與最直接可比的 GAAP 指標的對賬。

Please also refer to Catalent's Form 10-Q that will be filed with the SEC today for additional information on the risks and uncertainties that may bear on our operating results, performance and financial condition.

另請參閱 Catalent 將於今天向 SEC 提交的 10-Q 表格，以獲取有關可能對我們的經營業績、業績和財務狀況產生影響的風險和不確定性的更多信息。

Now I would like to turn the call over to Alessandro Maselli, whose opening remarks will begin on Slide 6 of the presentation.

現在我想把電話轉給 Alessandro Maselli，他的開場白將從演示文稿的幻燈片 6 開始。

Thanks, Paul, and welcome, everyone, to the call. We started the year with solid results and positive momentum as a strong constant currency growth in excess of 25% in non-COVID related revenues helped offset headwinds from lower COVID product demand, inflation and unfavorable foreign exchange translation.

謝謝，保羅，歡迎大家來電。今年年初，我們取得了穩健的業績和積極的勢頭，因為非 COVID 相關收入的強勁恆定貨幣增長超過 25%，有助於抵消 COVID 產品需求下降、通貨膨脹和不利的外匯兌換帶來的不利影響。

First, I would like to highlight that the results of the -- in the first quarter were initially expected to include $54 million of revenues and adjusted EBITDA related to the resolution of take-or-pay contracts for fill and finish of the Janssen viral vector COVID-19 vaccine at our Bloomington and Anagni sites. We agreed on a termination of the contracts, which reflect the changing demand patterns for the COVID-19 vaccines in order to accommodate these long-standing and significant customer as we set a new and strengthened framework for our growing partnership. We received agreed payments on these settled contracts in October and now expect the debt recognition of the related revenue will occur in the second quarter of this fiscal year. The change in the expected timing of these revenue recognitions was not a notable factor when we updated our fiscal '23 guidance, which I will cover in a few moments.

首先，我想強調的是，第一季度的結果最初預計將包括 5400 萬美元的收入和調整後的 EBITDA，這與解決楊森病毒載體填充和完成的照付不議合同有關在我們的布盧明頓和阿納尼工廠接種 COVID-19 疫苗。我們同意終止合同，這反映了 COVID-19 疫苗不斷變化的需求模式，以便在我們為不斷發展的合作夥伴關係建立新的和加強的框架時適應這些長期和重要的客戶。我們在 10 月份收到了這些已結算合同的商定付款，現在預計相關收入的債務確認將在本財年第二季度發生。當我們更新我們的 23 財年指導時，這些收入確認的預期時間變化並不是一個值得注意的因素，我將在稍後介紹。

Turning to our Q1 results. As shown on Slide 6, without including our revenues or adjusted EBITDA, the $54 million just discussed, we reported the first quarter revenue of $1.22 billion flat on a reported basis or a 4% increase in constant currency compared to the first quarter of fiscal '22.

轉向我們的第一季度業績。如幻燈片 6 所示，在不包括我們的收入或調整後的 EBITDA（剛剛討論的 5400 萬美元）的情況下，我們報告的第一季度收入為 12.2 億美元，與第一財季相比，按固定匯率計算增長了 4%。 22.

While we also exclude acquisition and divestitures, organic revenue declined 1% measured in constant currency.

雖然我們也排除了收購和資產剝離，但按固定匯率計算，有機收入下降了 1%。

Our first quarter adjusted EBITDA of $187 million declined 26% as reported or 24% on a constant currency basis compared to the first quarter of fiscal '22. When excluding the acquisition and divestitures, the decline was 28%, measured in constant currency.

與 22 財年第一季度相比，我們第一季度調整後的 EBITDA 為 1.87 億美元，如報告所述下降 26%，或按固定匯率計算下降 24%。如果不包括收購和資產剝離，按固定匯率計算，降幅為 28%。

Turning to the business, as noted on Slide 7, first quarter non-COVID organic constant currency growth was more than 20%. The growth in our non-COVID was driven by our cell and gene therapy offerings in our Biologics segment as well as our clinical development services in our Pharma and Consumer segment, which is starting to benefit from commercial synergies under the new organizational structure.

轉向業務，如幻燈片 7 所示，第一季度非 COVID 有機固定貨幣增長率超過 20%。我們非 COVID 的增長是由我們在生物製品部門的細胞和基因治療產品以及我們在製藥和消費者部門的臨床開發服務推動的，這些服務開始受益於新組織結構下的商業協同效應。

As we have shared in the past, we have strategically reinvested the COVID-related returns over the last -- over the past 2 years, which has helped to ensure we have the necessary growth levers in place to enable the future growth we are forecasting and we will continue taking the action to keep us on a path of success.

正如我們過去分享的那樣，我們在過去 2 年中戰略性地對與 COVID 相關的回報進行了再投資，這有助於確保我們擁有必要的增長槓桿，以實現我們預測的未來增長和我們將繼續採取行動，讓我們走上成功之路。

Slide 8 provides a schematic time lines of substantial non-COVID-related capacity we put in place during the last few years including the new capacity that we expect to activate as fiscal '23 continues to unfold.

幻燈片 8 提供了我們在過去幾年中建立的大量非 COVID 相關產能的示意時間表，包括我們預計隨著 23 財年繼續展開而激活的新產能。

As you can see, some of these growth drivers date back years, including our entry into cell therapy in February 2020 which was not expected to contribute meaningful revenue in its few years of ownership as we scale the business through internal investments and tuck-in M&A, including for IPSCs and plasmids. We now have the right assets in place to drive future earnings growth through these new modalities.

如您所見，其中一些增長動力可以追溯到幾年前，包括我們於 2020 年 2 月進入細胞療法領域，由於我們通過內部投資和併購來擴大業務規模，預計在其擁有的幾年內不會貢獻可觀的收入，包括 IPSC 和質粒。我們現在擁有合適的資產，可以通過這些新模式推動未來的盈利增長。

Other large expected contributors to our growth has been our organic investment to enhance our BWI gene therapy assets. A year ago, we brought online 6 additional sites to bring the sites total to 10 suites and now are running at high utilization rates.

我們增長的其他主要預期貢獻者是我們為增強我們的 BWI 基因治療資產而進行的有機投資。一年前，我們增加了 6 個站點，使站點總數達到 10 個套件，現在以高利用率運行。

In addition, we are now opening a new building on the same campus containing 8 more suites which will progressively come online over the next 12 months as our clients' pipeline progress.

此外，我們現在正在同一個園區開設一棟新大樓，其中包含另外 8 間套房，這些套房將在未來 12 個月內隨著我們客戶的管道進展而逐步上線。

Some of the other key investments we have made over the last few years include the drug product range capacity that led to recent tax answer wins, investments in additional single-use drug substance production capacity and our entry into the gamma nutritional supplement market just over a year ago, among others.

我們在過去幾年中進行的其他一些關鍵投資包括導致最近獲得稅收答复的藥品範圍能力、對額外一次性原料藥生產能力的投資以及我們進入伽馬營養補充劑市場的時間剛剛超過一年前，等等。

Laying on top of our organic growth drivers is the acquisition of Metrics Contract Services, which we closed on October 3. It is now accounted for in our updated guidance. This acquisition is just beginning to enable us to accelerate our existing plans to meet the increasing demand for fit-for-scale, high potent drug manufacturing.

除了我們的有機增長驅動因素之外，我們還收購了 Metrics Contract Services，我們於 10 月 3 日完成了收購。現在我們更新的指南中對此進行了說明。此次收購剛剛開始，使我們能夠加快現有計劃，以滿足對適合規模、高效藥物製造的日益增長的需求。

Underlying the growth in this business is the increasing number of potent compounds in the oral solids market, particularly in the oral oncology pipeline. Adding potent handling capabilities in fit-for-scale capacity through magic represents a continuation of our strategy to maintain a balanced portfolio of offerings that closely matches the overall industry's R&D pipeline, which includes a growing number of innovative small molecules that are complex to formulate or require specialized handling.

該業務增長的基礎是口服固體市場中越來越多的強效化合物，特別是在口腔腫瘤管道中。通過魔術在適合規模的容量中添加強大的處理能力代表了我們維持平衡產品組合的戰略的延續，該產品組合與整個行業的研發管道密切匹配，其中包括越來越多的難以配製或複雜的創新小分子需要專門處理。

Having explained why we continue to project a solid long-term growth for Catalent, I will briefly highlight factors that have led us to a more conservative orientation towards fiscal '23 and the decision to adjust our guidance for the year, including changes to the market conditions since our last call and some updated outlooks received from customers as well as other macroeconomic and sector-specific factors.

在解釋了為什麼我們繼續為 Catalent 預測穩健的長期增長後，我將簡要強調導致我們對 23 財年更加保守的定位以及調整我們今年指導的決定的因素，包括市場的變化自我們上次電話會議以來的狀況以及從客戶那裡收到的一些最新展望以及其他宏觀經濟和行業特定因素。

The macro factors include the further deterioration of the overall economic landscape, particularly in Europe, with increased likelihood of a recession and further tightening of capital markets.

宏觀因素包括整體經濟形勢進一步惡化，特別是在歐洲，經濟衰退的可能性增加和資本市場進一步收緊。

We are also beginning to see -- anticipate further ripple effects from either inflation, which is impacting the consumer confidence and discretionary spending. We are now seeing signs of lower end market demand for nutritional supplements.

我們也開始看到——預計通脹會產生進一步的連鎖反應，這會影響消費者信心和可自由支配的支出。我們現在看到市場對營養補充劑的需求下降的跡象。

In addition, we are experiencing delays in the delivery of the [new coming] manufacturing lines due to shortages of key components at our European suppliers. We have, therefore, adjusted our near-term growth assumptions for our consumer health offerings within our Pharma and Consumer Health segment. While our biopharma and consumer health pipelines remain robust, we are starting to experience signs of cash-sensitive decisions by some of our customers. This is most evident in relationship to inventory levels for finished goods or the prioritization of their candidates as they progress through the pipeline. Our adjusted forecast also reflects in these new trends.

此外，由於我們歐洲供應商的關鍵部件短缺，我們正在經歷 [新來的] 生產線的交付延遲。因此，我們調整了我們在醫藥和消費者健康領域內消費者健康產品的近期增長假設。雖然我們的生物製藥和消費者健康產品線依然強勁，但我們開始看到一些客戶做出現金敏感決策的跡象。這在與成品庫存水平或候選者在管道中進展時的優先級的關係中最為明顯。我們調整後的預測也反映在這些新趨勢中。

Finally, after several years of elevated levels of capital expenditures we have made the fiscally prudent decision to rephase some of our CapEx spending planned for this year to maximize utilization, increase free cash flow as we load our balance sheet. Some of the capacity we initially factored into our initial fiscal '23 guidance will now be delayed into fiscal '24, but this rephasing will not impact our long-term growth targets.

最後，經過幾年資本支出水平的提高，我們做出了審慎的財政決定，重新調整今年計劃的部分資本支出支出，以最大限度地提高利用率，在加載資產負債表時增加自由現金流。我們最初在 23 財年指導中考慮的部分產能現在將推遲到 24 財年，但這種重新調整不會影響我們的長期增長目標。

To respond to the urgent patient demand for vaccines and therapies during the pandemic, we significantly increased our direct and interest cost base for the past 2 years, negatively impacting our operating efficiency. Given the new conservative approach the management team has been working diligently on plans to optimize the cost structure of the organization as we cover our historical productivity levels. Many of these actions are already in flight and all are expected to be operationalized by the end of this calendar year. This is also reflected in the revised guidance.

為了應對大流行期間患者對疫苗和療法的迫切需求，我們在過去 2 年顯著增加了直接和利息成本基礎，對我們的運營效率產生了負面影響。鑑於新的保守方法，管理團隊一直在努力製定計劃，以優化組織的成本結構，因為我們涵蓋了我們的歷史生產力水平。其中許多行動已經開始實施，預計所有行動都將在本日曆年年底前實施。這也反映在修訂後的指南中。

While we are taking the prudent step of adjusting guidance as we navigate the exit from the pandemic I want to be clear that our underlying business still displays signed significant areas of strength as some examples. We continue to forecast strong growth for our overall non-COVID business. Our Zydis business continued its historic record performance. Our gene therapy business has proven out that the thesis we lay out when we initially acquired the Paragon Bioservices and our overall funnel of new non-COVID opportunities is at a record high.

雖然我們在走出大流行的過程中採取了調整指導的謹慎步驟，但我想明確一點，我們的基礎業務仍然顯示出明顯的優勢領域，例如一些例子。我們繼續預測我們整體非 COVID 業務的強勁增長。我們的 Zydis 業務繼續創下歷史新高。我們的基因治療業務已經證明，我們最初收購 Paragon Bioservices 時提出的論點以及我們新的非 COVID 機會的整體漏斗處於創紀錄的高位。

Shifting gears, I would like to address the FDA audits over the summer that led to Form 483 observations. Quality and compliance are central to everything we do, and we invest constantly to assure the strength of our quality systems and the quality of our operations. And that quality is constantly audited.

換檔，我想在夏季解決導致 483 表觀察的 FDA 審計。質量和合規性是我們所做的一切的核心，我們不斷投資以確保我們的質量體系的實力和我們的運營質量。並且這種質量會不斷受到審核。

In fiscal '22, our facility was subject to approximately 715 inspections, including more than 50 from FDA and other drug regulators around the world as well as hundreds of customer audits and audits by our own, independently managed internal audit staff and [detox] consultants. So regulators inspections occur routinely and all of us, regulators, customers and Catalent are all working to assure that patients receive timely, safe, efficacious and quality medicines and vaccines. We did so routinely despite the challenges of the pandemic, as we provided vaccines to many millions of people around the world, and we will continue to do so.

在 22 財年，我們的設施接受了大約 715 次檢查，其中包括來自 FDA 和世界各地其他藥物監管機構的 50 多次檢查，以及我們自己獨立管理的內部審計人員和 [detox] 顧問進行的數百次客戶審計和審計.因此，監管機構的檢查會定期進行，我們所有人、監管機構、客戶和康泰倫特都在努力確保患者獲得及時、安全、有效和優質的藥物和疫苗。儘管面臨大流行的挑戰，我們還是照常這樣做，因為我們為全世界數百萬人提供了疫苗，而且我們將繼續這樣做。

With that said, the regulatory compliance landscape is always evolving, including what is considered best practice. And so we take all of this observation we receive seriously, and respond to them in analystic and complete way. We believe that our responses by our Bloomington and Brussels teams will comprehensively address the recent FDA observations and they've already deployed all necessary resources to implement the changes which we have committed in a timely manner.

話雖如此，監管合規環境總是在不斷發展，包括被認為是最佳實踐的東西。所以我們認真對待我們收到的所有這些觀察，並以分析和完整的方式回應它們。我們相信，我們的布盧明頓和布魯塞爾團隊的回應將全面解決 FDA 最近的觀察結果，他們已經部署了所有必要的資源來及時實施我們所做的改變。

To close this topic, and I want to highlight this. While there are some near-term negative P&L effects as we address these observations, the overall related limitations costs are not a notable factor in our revised full year outlook.

結束這個話題，我想強調一下。雖然在我們處理這些觀察結果時存在一些近期的負面損益影響，但總體相關限製成本並不是我們修訂的全年展望中的一個顯著因素。

To close my remarks, we continue to be excited about the breadth of our offering and their ability to meet customer needs, which will drive meaningful growth even in a less favorable macroeconomic environment.

最後，我們繼續對我們產品的廣度及其滿足客戶需求的能力感到興奮，即使在不太有利的宏觀經濟環境下，這也將推動有意義的增長。

With the sharp drop in COVID-19 vaccine demand, we pivoted to alternative future growth drivers early in the pandemic cycle and are starting to see the fruits of those investments. We remain deeply focused on executing our mission to develop, manufacture and supply products that help people live better and healthier lives while enhancing value for our shareholders.

隨著 COVID-19 疫苗需求的急劇下降，我們在大流行週期的早期轉向了替代的未來增長動力，並開始看到這些投資的成果。我們始終專注於執行我們的使命，即開發、製造和供應產品，幫助人們過上更好、更健康的生活，同時為我們的股東提高價值。

Now I would like to turn the call over to Tom.

現在我想把電話轉給湯姆。

Thanks, Alessandro. I'll begin this morning with a discussion on segment performance, where commentary around segment growth will be in constant currency. This is the first quarter we are reporting under our new segment structure announced back in July. In both our Q1 earnings release and slide presentation, we are providing historical revenue and EBITDA results that have been recasted as if these segments have been in place for fiscal 2021 and 2022.

謝謝，亞歷山德羅。我將在今天早上開始討論細分市場的表現，圍繞細分市場增長的評論將以不變的貨幣進行。這是我們在 7 月宣布的新部門結構下報告的第一季度。在我們的第一季度收益發布和幻燈片演示中，我們提供了經過重鑄的歷史收入和 EBITDA 結果，就好像這些部分已經在 2021 財年和 2022 財年到位一樣。

I will start on Slide 9 with the Biologics segment. Biologics net revenue in Q1 of $523 million decreased 2% compared to the first quarter of 2022. The decline is primarily the result of a settlement of take-or-pay contracts for a COVID vaccine that was not considered revenue in the quarter but was previously expected to. We will offset the negative impact later in the fiscal year, likely in the second quarter, following the completion of an outstanding performance obligation for the client.

我將從幻燈片 9 開始，介紹生物製品部分。與 2022 年第一季度相比，Biologics 第一季度的淨收入為 5.23 億美元，下降了 2%。下降主要是由於 COVID 疫苗的照付不議合同結算的結果，該合同在本季度不被視為收入，但之前被視為收入。預計。在完成客戶未完成的履約義務後，我們將在本財年晚些時候（可能在第二季度）抵消負面影響。

If we were to include this amount as revenue in Q1, we would have seen growth year-over-year, fueled organically by strong demand for our non-COVID programs, particularly our cell and gene therapy offering. This strong demand more than offset the decrease in revenue from COVID-related programs.

如果我們將這一數額計入第一季度的收入，我們將看到同比增長，這是由於對我們的非 COVID 項目的強勁需求，特別是我們的細胞和基因治療產品的強勁需求。這種強勁的需求足以抵消 COVID 相關項目收入的減少。

The segment's EBITDA margin of 21.5% was lower by nearly 900 basis points year-over-year from the 30.4% recorded in the first quarter of fiscal 2022. Year-over-year margin primarily contracted due to the underutilized capacity. Other factors included the remediation activity in Brussels, which is ongoing as well as the negative carry related to the Princeton and Oxford facilities.

該部門的 EBITDA 利潤率為 21.5%，較 2022 財年第一季度的 30.4% 同比下降近 900 個基點。同比利潤率下降主要是由於產能未充分利用。其他因素包括布魯塞爾正在進行的整治活動，以及與普林斯頓和牛津設施相關的負面影響。

As shown on Slide 10, our Pharma and Consumer Health segment generated net revenue of $499 million, an increase of 11% compared to the first quarter of fiscal 2022. With segment EBITDA increasing 20% over the same period last fiscal year.

如幻燈片 10 所示，我們的製藥和消費者健康部門產生了 4.99 億美元的淨收入，與 2022 財年第一季度相比增長了 11%。與上一財年同期相比，部門 EBITDA 增長了 20%。

Both top and bottom line growth were driven inorganically from the acquisition of the Bettera business. Bettera contributed 10 percentage points to PCHs net revenue growth and 12 percentage points to segment EBITDA growth during the quarter. As a reminder, starting in Q2, Bettera will be considered organic.

收入和利潤的增長都是由收購 Bettera 業務間接推動的。 Bettera 在本季度為 PCH 的淨收入增長貢獻了 10 個百分點，對細分 EBITDA 增長貢獻了 12 個百分點。提醒一下，從第二季度開始，Bettera 將被視為有機產品。

The organic PCH business did see modest revenue growth driven by a wide variety of development offerings, including clinical development supply. Partial offsets to growth came from a decline in prescription drug products and the mandatory closure of our largest PCH site located on Florida's West Coast due to Hurricane Ian. The site was closed for 4 days but did not withstand any structural damage.

有機 PCH 業務確實在包括臨床開發供應在內的各種開發產品的推動下實現了適度的收入增長。增長的部分抵消來自處方藥產品的下降以及由於颶風伊恩而強制關閉我們位於佛羅里達州西海岸的最大 PCH 站點。該站點關閉了 4 天，但沒有承受任何結構損壞。

Moving to our consolidated adjusted EBITDA on Slide 11. Our first quarter adjusted EBITDA decreased 26% to $187 million or 18.3% of net revenue.

轉到幻燈片 11 上的合併調整後 EBITDA。我們第一季度調整後的 EBITDA 下降 26% 至 1.87 億美元，占淨收入的 18.3%。

On a constant currency basis, our first quarter adjusted EBITDA declined 24% compared to the first quarter of the prior year due primarily to the year-over-year decline in COVID-related activity.

在固定貨幣基礎上，我們第一季度調整後的 EBITDA 與去年第一季度相比下降了 24%，這主要是由於與 COVID 相關的活動同比下降。

As shown on Slide 12, first quarter adjusted net income was $61 million or $0.34 per diluted share compared to adjusted net income of $128 million or $0.71 per diluted share in the first quarter a year ago.

如幻燈片 12 所示，第一季度調整後淨收入為 6100 萬美元或稀釋後每股收益 0.34 美元，而去年第一季度調整後淨收入為 1.28 億美元或稀釋後每股收益 0.71 美元。

Note that our income tax rate was higher in the first quarter than our full year expectation because of the front-loaded weighting in higher tax jurisdictions, which we expect to normalize over the remainder of the fiscal year.

請注意，我們第一季度的所得稅率高於我們全年的預期，因為在較高稅收管轄區的前期加權，我們預計在本財年剩餘時間內將正常化。

Slide 13 shows our debt-related ratios and capital allocation priorities. Catalent's net leverage ratio as of June 30, 2022, was 3.2x, slightly above our long-term target of 3.0x. On a pro forma basis, for which we assume the Metrics acquisition closed on September 30, 2022, as opposed to October 3, 2022, Catalent's net leverage ratio would have been 3.6x. This compares to net leverage of 2.9x on June 30, 2022, and 2.1x on September 30, 2021. Our combined balance of cash, cash equivalents and marketable securities as of September 30, 2022, was $345 million compared to $538 million as of June 30, 2022. Note that free cash flow still remains negatively impacted by our strategic decision to hold increased inventory levels. When we feel the time is appropriate and are more comfortable with the stabilization of our supply chain, we will begin to reverse course.

幻燈片 13 顯示了我們的債務相關比率和資本配置優先事項。截至 2022 年 6 月 30 日，康泰倫特的淨槓桿率為 3.2 倍，略高於我們 3.0 倍的長期目標。在備考基礎上，我們假設 Metrics 收購於 2022 年 9 月 30 日結束，而不是 2022 年 10 月 3 日，Catalent 的淨槓桿率將是 3.6 倍。相比之下，2022 年 6 月 30 日的淨槓桿為 2.9 倍，2021 年 9 月 30 日為 2.1 倍。截至 2022 年 9 月 30 日，我們的現金、現金等價物和有價證券的總餘額為 3.45 億美元，而截至 2022 年 9 月 30 日為 5.38 億美元2022 年 6 月 30 日。請注意，自由現金流仍然受到我們保持增加庫存水平的戰略決策的負面影響。當我們覺得時機合適並且對穩定我們的供應鏈更加滿意時，我們將開始扭轉方向。

As of September 30, 2022, our contract asset balance was $461 million, an increase of $20 million compared to June 30, 2022. The overwhelming majority of this increase is related to some notably large development programs, particularly within our Biologics segment, where revenue was recorded based on a percentage of completion versus entirely on back release as it is for commercial programs. This difference in approach affects when we are able to invoice customers, thereby delaying cash realization and negatively affecting free cash flow. The expectation, however, is that this figure will decrease throughout the fiscal year as we make progress in shortening the cycle time.

截至 2022 年 9 月 30 日，我們的合同資產餘額為 4.61 億美元，與 2022 年 6 月 30 日相比增加了 2,000 萬美元。這一增長的絕大部分與一些顯著的大型開發項目有關，特別是在我們的生物製品部門，其中收入是根據完成百分比記錄的，而不是像商業程序一樣完全在後發佈時記錄。這種方法上的差異會影響我們何時能夠為客戶開具發票，從而延遲現金變現並對自由現金流產生負面影響。然而，隨著我們在縮短週期時間方面取得進展，預計這一數字將在整個財年下降。

As a final point regarding our free cash flow, I note that the decrease in contract liabilities also had a negative impact. Our contract liabilities arise predominantly within our Biologics segment and are linked to upfront cash proceeds related to our gene therapy programs.

作為關於我們的自由現金流的最後一點，我注意到合同負債的減少也產生了負面影響。我們的合同負債主要發生在我們的生物製品部門，並與與我們的基因治療計劃相關的前期現金收益相關聯。

As these programs mature and the performance obligations are met, these balances will shift to recognized revenue, and we have already seen this play out with several large gene therapy customers over the last several quarters.

隨著這些計劃的成熟和履約義務的履行，這些餘額將轉移到確認的收入中，我們已經在過去幾個季度看到了幾家大型基因治療客戶的情況。

Moving on to capital expenditures. We now expect our fiscal '23 CapEx as a percentage of revenue to be between 10% and 11%, down from our previous projection of 13% to 15%. This moderated rate of CapEx spend and overall more prudent approach to capital deployment as we navigate through a challenging macroeconomic environment better positions Catalent for free cash flow generation.

繼續進行資本支出。我們現在預計我們的 23 財年資本支出佔收入的百分比將在 10% 至 11% 之間，低於我們之前預測的 13% 至 15%。隨著我們在充滿挑戰的宏觀經濟環境中導航，這種資本支出支出的緩和以及總體上更謹慎的資本部署方法使 Catalent 能夠更好地產生自由現金流。

As we have previously shared, we accelerated several planned initiatives to address the pandemic and build capabilities for new modalities sooner. This has put the company today in a position to leverage these new assets and capabilities earlier than anticipated and lead to continued strong non-COVID revenue growth.

正如我們之前分享的那樣，我們加快了幾項計劃中的舉措，以應對這一流行病並更快地建立新模式的能力。這使公司今天能夠比預期更早地利用這些新資產和能力，並導致持續強勁的非 COVID 收入增長。

Now we turn to our adjusted financial outlook for fiscal 2023 as outlined on Slide 14. This new outlook assumes the challenging macroeconomic environment will persist longer than originally expected back in August, which justifies a more conservative orientation. It also reflects our acquisitions of Metrics, which closed just after the end of the first quarter. We now expect full year net revenue in the range of $4.625 billion to $4.875 billion, representing a range of 4% decline at the low end and 1% increase at the high end on an as-reported basis compared to fiscal 2022. FX continues to be a headwind with an incremental impact of approximately 1 percentage point on both revenue and adjusted EBITDA versus our previous guidance. As a reminder, the guidance we announced in August already included a negative FX impact of approximately 3 to 4 percentage points on our revenue and adjusted EBITDA growth.

現在，我們轉向幻燈片 14 中概述的調整後的 2023 財年財務展望。這一新展望假設具有挑戰性的宏觀經濟環境將比 8 月份最初預期的持續時間更長，這證明了更保守的方向是合理的。這也反映了我們對 Metrics 的收購，後者在第一季度末剛剛結束。我們現在預計全年淨收入在 46.25 億美元至 48.75 億美元之間，與 2022 財年相比，低端下降 4%，高端增長 1%。與我們之前的指導相比，對收入和調整後的 EBITDA 的影響增加約 1 個百分點。提醒一下，我們在 8 月宣布的指導已經包括對我們的收入和調整後 EBITDA 增長約 3 至 4 個百分點的負面外匯影響。

So after taking into account these considerations, our revised expected organic constant currency net revenue growth rate in fiscal '23 is expected to be essentially flat at the midpoint of the guidance range.

因此，在考慮到這些因素後，我們修訂後的 23 財年預期有機固定貨幣淨收入增長率預計將基本持平在指導範圍的中點。

For full year adjusted EBITDA, we now expect a range of $1.22 billion to $1.30 billion, representing a decline of 5% at the low end of the range and an increase of 1% at the high end of the range compared to fiscal 2022. You are familiar with the seasonal nature of our business, where revenue and EBITDA generation are each more weighted to the back half of the year, which has historically led to approximately 60% of our EBITDA to be realized in that period.

對於全年調整後的 EBITDA，我們現在預計範圍為 12.2 億美元至 13.0 億美元，與 2022 財年相比，該範圍的低端下降 5%，該範圍的高端增長 1%。您熟悉我們業務的季節性性質，其中收入和 EBITDA 產生的權重分別在下半年，從歷史上看，這導致我們大約 60% 的 EBITDA 將在該期間實現。

In fiscal 2023, because we just started the implementation of our cost efficiency activities, we now expect adjusted EBITDA to be even more weighted to the back half of the year at approximately 63% to 64%. This also accounts for the much more pronounced year-on-year decline of COVID-related revenue we expect in the second quarter versus the first quarter.

在 2023 財年，由於我們剛剛開始實施成本效率活動，我們現在預計調整後的 EBITDA 在下半年的權重將更大，約為 63% 至 64%。這也說明了我們預計第二季度與第一季度相比，與 COVID 相關的收入同比下降更為明顯。

There are a number of factors that continue to negatively impact margins in fiscal 2023 that we reviewed last quarter, but that will be partly offset by our cost saving actions. The factors include headwinds from COVID-related volume declines, inflationary and supply chain pressures, start-up costs related to our acquisitions of Princeton and Oxford, which we are absorbing in our organic assumptions, other pockets of underutilization across the network as we bring on additional capacity and foreign exchange translations as our margin profile is higher outside of the U.S., while the majority of our corporate costs are domestic. Note that swings in the euro have a greater impact on FX translation than the pound.

我們上個季度審查的 2023 財年有許多因素繼續對利潤率產生負面影響，但這將被我們的成本節約行動部分抵消。這些因素包括與 COVID 相關的銷量下降帶來的不利因素、通貨膨脹和供應鏈壓力、與我們收購普林斯頓大學和牛津大學相關的啟動成本，我們正在將這些成本納入我們的有機假設中，以及我們帶來的其他網絡未充分利用的口袋額外的產能和外匯翻譯，因為我們在美國以外的利潤率更高，而我們的大部分公司成本都在國內。請注意，歐元波動對外匯換算的影響大於英鎊。

Moving to adjusted net income. We now expect full year ANI of $567 million to $648 million, representing a range from a decline of 18% to a decline of 7% on an as-reported basis compared to fiscal 2022.

轉向調整後的淨收入。我們現在預計全年 ANI 為 5.67 億美元至 6.48 億美元，與 2022 財年相比，報告的基礎上下降 18% 至 7%。

The ANI decline we foresee for fiscal '23 is being driven by several items. First, the inclusion of the new debt used to fund the Metrics acquisition, which closed in October. Second, servicing the full year of the new variable debt we raised in part from the Bettera acquisition as well as other interest-related increases in the current rising interest rate environment.

我們預計 23 財年的 ANI 下降是由幾個因素驅動的。首先，包括用於資助 Metrics 收購的新債務，該收購於 10 月結束。其次，為全年我們通過收購 Bettera 籌集的新可變債務以及當前利率上升環境中的其他與利息相關的增長提供服務。

Next, our expectations for our full fiscal '23 tax rate remain unchanged from prior guidance. But as a reminder, we'll experience a higher effective tax rate in the 24% to 25% range compared to the 23.4% we saw in fiscal 2022 due to the geographic mix of earnings.

接下來，我們對 23 財年全部稅率的預期與之前的指導保持不變。但提醒一下，由於收入的地域組合，與我們在 2022 財年看到的 23.4% 相比，我們將在 24% 至 25% 的範圍內經歷更高的有效稅率。

And finally, increased depreciation expense due to our significantly larger asset base which is also more heavily weighted towards the U.S. We continue to expect our share count to be in the range of 181 million to 183 million shares.

最後，由於我們的資產基礎顯著擴大，而折舊費用也增加了，而美國的權重也更大。我們繼續預計我們的股票數量將在 1.81 億股至 1.83 億股之間。

Operator, this concludes our prepared remarks, and we'd now like to open the call for questions.

接線員，我們準備好的發言到此結束，我們現在要開始提問。

(Operator Instructions)

（操作員說明）

Our first question comes from the line of Luke Sergott of Barclays.

我們的第一個問題來自巴克萊銀行的 Luke Sergott。

Our next question comes from Tejas Savant of Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Tejas Savant。

Appreciate the time here. Perhaps Alessandro and Tom, just to kick things off on the guide, can you help us just build a bridge between the old and the new outlook at the midpoint. It sounds like you trimmed your top line by about [$350 million EBITDA by 90]. And I'm assuming the COVID payment should have no impact and the hurricane Ian impact assuming can also be recaptured down the road. But I was just curious in terms of what are your new growth assumptions that you're embedding for non-COVID biologics as well as the PCH segment growth in addition to the Metrics deal?

珍惜這裡的時間。也許亞歷山德羅和湯姆，只是為了開始指南，你能幫助我們在中點建立新舊前景之間的橋樑。聽起來您將您的收入削減了大約 [3.5 億美元的 EBITDA 到 90]。而且我假設 COVID 付款應該沒有影響，假設颶風伊恩的影響也可以在路上重新奪回。但我只是好奇，除了 Metrics 交易外，您對非 COVID 生物製劑以及 PCH 細分市場的增長有何新的增長假設？

So thanks, Tejas for the question. Alessandro here. I will cover quickly part of it, and then I'll hand over to Tom. Look, as you see in the first quarter, we recorded a non-COVID growth as we expected in the range of 20% plus and we expect this to continue through the year. Tom, would you like to give a little bit more details?

所以謝謝，光輝的問題。亞歷山德羅在這裡。我將快速介紹其中的一部分，然後交給湯姆。看，正如您在第一季度看到的那樣，我們記錄了非 COVID 增長，正如我們預期的那樣，增長幅度在 20% 以上，我們預計這種情況將持續到今年。湯姆，你願意提供更多細節嗎？

Sure. So good question, Tejas, related to the guidance. I think your assumptions related to both the timing of the revenue recognition item as well as the hurricane are not impactful in terms of the full year guidance. Both of those we view as timing related. The macroeconomic backdrop and the worsening conditions we're seeing there are much more of the driver here of the call down. I would say, as we look at consumer confidence and discretionary spend and the impacts we're seeing there, related to our Consumer Health business. I would say that's probably 25% to 35% of the call down related to those items.

當然。好問題，Tejas，與指導有關。我認為您對收入確認項目時間和颶風的假設對全年指導沒有影響。我們認為兩者都與時間有關。宏觀經濟背景和我們看到的情況惡化，這裡有更多的驅動因素。我想說，當我們審視消費者信心和可自由支配支出以及我們在那裡看到的與我們的消費者健康業務相關的影響時。我會說這可能是與這些項目相關的呼叫的 25% 到 35%。

I would say that the cash-sensitive decisions that we're seeing from some of our customers is not only related to biologic-related customers. We're seeing that on the Pharma and Consumer Health side as well, especially as it pertains to levels of safety stock inventory that customers are willing to hold at this point in time if they take what we view as a more cash preservation approach to managing their overall supply chain as well as how they're thinking about the prioritization of some of the candidates that they have in their pipeline as well as the timing of the progression of those. So those are, I would say, the larger factors that we continue to see here. Your comments also around metrics. That is the -- that acquisition did close in October. That is included in our guidance now as well as the further strengthening of the U.S. dollars that we're seeing here.

我想說的是，我們從一些客戶那裡看到的對現金敏感的決定不僅與生物相關客戶有關。我們在製藥和消費者健康方面也看到了這一點，特別是因為它與客戶願意在此時持有的安全庫存水平有關，如果他們採用我們認為更現金保存的方法來管理他們的整體供應鏈以及他們如何考慮他們在管道中的一些候選人的優先級以及這些候選人的進展時間。所以，我想說，這些是我們在這裡繼續看到的更大的因素。您的評論也圍繞指標。那就是——那次收購確實在 10 月完成。這包括在我們現在的指導以及我們在這裡看到的美元進一步走強中。

Those two things, I would say, nearly offset, maybe not quite exactly, but they are directionally in the same approach. And the macroeconomic landscape obviously has just given us a much more conservative orientation to look at the remainder of the fiscal year.

我想說，這兩件事幾乎是相互抵消的，也許並不完全一致，但它們在方向上是相同的。宏觀經濟形勢顯然給了我們一個更加保守的方向來看待本財年的剩餘時間。

Got it. That's super helpful. And then as sort of an unrelated follow-up. Alessandro, two questions. One on the quality front and one on your CapEx decision to trim the spending outlook here. So on the quality front, you noted that both Brussels and Bloomington are now operational. So can you just share any update, particularly in terms of your confidence in your ability to ramp manufacturing for customers at the site, irrespective of what happens with some of these 483 letters that you've received and the activities you're taking to address them as well as any sort of customer conversations around future projects. Has any of this noise had any impact on that?

知道了。這非常有幫助。然後作為一種不相關的後續行動。亞歷山德羅，兩個問題。一個是質量方面的，一個是你決定削減支出前景的資本支出。所以在質量方面，你注意到布魯塞爾和布盧明頓現在都在運作。因此，您能否分享任何更新，尤其是在您對在現場為客戶增加製造能力的信心方面，無論您收到的這 483 封信中的一些發生了什麼以及您正在採取的活動解決他們以及圍繞未來項目的任何類型的客戶對話。這些噪音是否對此有任何影響？

And second, on CapEx, with the decision to pull back CapEx here a little bit given the macro, can you just talk to us about your ability to continue to meet demand at least over the near term given the push out to fiscal '24?

其次，在資本支出方面，鑑於宏觀因素決定在這裡稍微撤回資本支出，您能否與我們談談您至少在短期內繼續滿足需求的能力，因為該公司將推出 24 財年？

Yes, sure. Look, on the first question, I would say that what we provided in the prepared remarks is pretty comprehensive in terms of describing the status there. So I was for sure adding any more color to that because I believe that it's pretty comprehensive for sure, there are we continue to keep a fully transparent approach with our customers and sharing with them updates. But at this point in time, as we said, we are confident that our responses are addressing the observation as expected.

是的，當然。看，關於第一個問題，我想說我們在準備好的評論中提供的內容在描述那裡的狀態方面非常全面。所以我肯定會為此添加更多顏色，因為我相信它肯定非常全面，我們將繼續與我們的客戶保持完全透明的方法並與他們分享更新。但正如我們所說，在這個時間點，我們有信心我們的反應正在解決預期的觀察結果。

With regards to your question on CapEx, that's a very good question. Look, the reality when you go to Slide 8 of our presentation, that slide that really illustrates what we have already done and what we have in flight.

關於您關於資本支出的問題，這是一個非常好的問題。看，當您轉到我們演示文稿的第 8 張幻燈片時的現實情況，該幻燈片真正說明了我們已經完成的工作以及我們正在實施的工作。

As you will recall, in one of the conversation, you and I had a few weeks ago, I did tell you that we were in the mode of making sure that we had excess capacity across the board to make sure that there was never the concern of not having enough capacity. I believe given the current macroeconomic environment, we decided that the capacity -- our assessment is the capacity that we have is more than enough for the runway that we have in front of us for the next several quarters, and there will be plenty of time as we rephase the CapEx more in fiscal '24 to be in the same very position to continue to drive long-term growth. So that is really not affecting our long-term outlook here.

你會記得，在你和我幾週前的一次談話中，我確實告訴過你，我們正處於確保我們全面擁有過剩產能的模式，以確保永遠不會出現問題沒有足夠的容量。我相信鑑於當前的宏觀經濟環境，我們決定產能——我們的評估是，我們擁有的產能足以應付未來幾個季度擺在我們面前的跑道，而且會有充足的時間隨著我們在 24 財年更多地重新調整資本支出，使其處於同樣的位置，以繼續推動長期增長。所以這真的不會影響我們的長期前景。

And I'll just add, Tejas, in the near term, really, the only two CapEx projects that we have that I would say would have an impact on our fiscal '23 year, the decision to delay both related to Oxford and Princeton. Those are now expected to come online during fiscal '24 and contribute revenue in that period versus in the current fiscal year.

我只想補充一點，Tejas，在短期內，真的，我們僅有的兩個資本支出項目，我會說會對我們的 23 財年產生影響，即推遲與牛津和普林斯頓有關的決定。現在預計這些將在 24 財年上線，並在該期間與當前財年相比貢獻收入。

Our next question is from Sean Dodge from RBC Capital Markets.

我們的下一個問題來自加拿大皇家銀行資本市場的 Sean Dodge。

Maybe just staying on the guidance for a moment. The changes there from the cash sensitive decisions you're seeing from some customers. Just to clarify, is that something you're seeing in Europe only? Or is that happening in the United States, too? And then Tom, you said happening both on biologics and the PCH side. Is there any more context you can give us there? Is that the smaller clients making these decisions or larger ones, too? And then maybe any more kind of pockets or characterization you give us of the cash-sensitive decision?

也許只是停留片刻。您從一些客戶那裡看到的現金敏感決策的變化。澄清一下，你只在歐洲看到過這種情況嗎？或者這也發生在美國？然後湯姆，你說在生物製劑和 PCH 方面都發生了。你可以給我們更多的背景信息嗎？是較小的客戶做出這些決定還是較大的客戶也做出這些決定？然後也許你給了我們更多關於現金敏感決定的口袋或特徵？

Yes, Sean. I would say this is not just the dynamic we're seeing in Europe. We're seeing it across both, I would say, our European and U.S.-based customers. I did say that this is a dynamic that is crossing both our Pharma and Consumer Health and Biologics segments. I would say, on the Pharma and Consumer Health side, it's more related to commercial products and consumer health products. And I think it's really driven by cash decisions. I believe that our customers are making in terms of how they're managing their supply chain. And it's not just tied to smaller customers either. I mean I think our approach as a large company in terms of looking at things from a more conservative cash flow position is exactly what we're seeing from some of our customers do as well as they look to manage working capital and supply chain in this macroeconomic backdrop. So much more across the board, both large and small customers and also across biologics and the Pharma and Consumer Health.

是的，肖恩。我想說這不僅僅是我們在歐洲看到的動態。我想說，我們在歐洲和美國的客戶中都看到了這一點。我確實說過，這是一種跨越我們製藥、消費者健康和生物製品領域的動態。我想說，在製藥和消費者健康方面，它更多地與商業產品和消費者健康產品相關。我認為這真的是由現金決策驅動的。我相信我們的客戶在他們如何管理他們的供應鏈方面做出了貢獻。它也不僅僅與小客戶有關。我的意思是，我認為我們作為一家大公司從更保守的現金流角度看待事物的方法正是我們從一些客戶那裡看到的，他們希望在這方面管理營運資金和供應鏈宏觀經濟背景。如此多的全面，無論是大客戶還是小客戶，以及生物製品、製藥和消費者健康領域。

The only other thing I'll add is related to the examination of the pipeline and progression of their pipeline, some of the slowdown we're seeing there, that's more attributable to the biologics side of the business. But again, I wouldn't say it's only tied to smaller customers. We're seeing some larger customers that may not be in Phase III, but in more earlier Phase I and Phase II programs, just looking to slow play them as they navigate through the macroeconomic environment.

我要補充的唯一另一件事是與管道的檢查和管道的進展有關，我們在那裡看到的一些放緩，這更多地歸因於業務的生物製劑方面。但同樣，我不會說它只與小客戶有關。我們看到一些較大的客戶可能不在第三階段，而是在更早期的第一階段和第二階段計劃中，只是希望在他們在宏觀經濟環境中導航時放慢速度。

Okay. And then just thinking about some of the factors that give you visibility on the new guidance. If we go back to the tech transfers you all talked about before, is there anything else you can share that give us some sense of how meaningful those should be in aggregate to the year, maybe like the incremental contribution of revenue from those? Does that cover a quarter of what you need to hit the new guidance? Or is it more or less than that?

好的。然後只是考慮一些可以讓您了解新指南的因素。如果我們回到你們之前討論過的技術轉移，你還有什麼可以分享的，讓我們了解這些技術對今年的總體意義有多大，比如這些收入的增量貢獻？這是否涵蓋了您達到新指南所需的四分之一？還是比這更多或更少？

There's been no change, I would say, with regards to the assumptions around those tech transfer programs. They continue to be a meaningful contributor to us in the fiscal year. There are several of those that will be ramping on through the fiscal year here. So we're not going to quantify those, Sean, in terms of what their contributions. We don't talk about individual customers or products. And so I would just say that, that continues to be a driver of improved capacity utilization as well as revenue growth as we get into the second half of the year.

我想說，關於這些技術轉讓計劃的假設沒有任何變化。他們在本財年繼續為我們做出有意義的貢獻。其中有幾個將在本財年逐步增加。所以我們不打算量化這些，肖恩，就他們的貢獻而言。我們不談論個人客戶或產品。所以我只想說，隨著我們進入下半年，這仍然是提高產能利用率和收入增長的驅動力。

Yes. And I would add, look, when you look at the drivers that give us conviction about the non-COVID growth pointing to this [tax asset,] but also gene therapy, which was a strong contributor to our performance in Q1. We continue to see -- to have a good visibility into the trends in these areas of the business. So the visibility on these assets to continue to perform is good.

是的。我還要補充一點，當你看到讓我們確信非 COVID 增長指向這一 [稅收資產] 的驅動因素時，我還要補充一點，基因療法也是我們第一季度業績的重要貢獻者。我們繼續看到 - 對這些業務領域的趨勢有很好的了解。因此，這些資產繼續表現良好的可見性。

Our next question is from Dave Windley from Jefferies.

我們的下一個問題來自 Jefferies 的 Dave Windley。

My first question kind of similar to one of Sean's around revenue mix. I'm wondering if you could -- I'm trying to get a better understanding of the relative balance of the impact of the items that you're calling out that drive the reduced guidance across biologics and PCH. It kind of sounds to me like maybe more of it is TCH leaning than biologics, but I don't want to overassume there. Could you give us some help.

我的第一個問題類似於肖恩關於收入組合的問題。我想知道你是否可以 - 我試圖更好地了解你所呼籲的項目的影響的相對平衡，這些項目導致生物製劑和 PCH 的指導減少。在我看來，這聽起來可能更多的是 TCH 而非生物製劑，但我不想過分假設。你能給我們一些幫助嗎？

Sure, Dave. So I would say the de-risking approach we've taken and the more conservative approach we've taken to guidance here really spans both PCH as well as our Biologics segment. I wouldn't necessarily say it's overly weighted towards the PCH side of the segment, I think where we're seeing the bulk of the impact to PCH is related to the consumer confidence, discretionary spend given the macroeconomic inflationary environment that we're seeing, that has a more immediate impact, particularly on the pharma -- sorry, on the consumer health side of the business, the gummies business, but also just -- I would say, the softgel business associated with OTC and consumer products.

當然，戴夫。因此，我想說我們採取的去風險方法和我們在這裡採取的更保守的指導方法確實涵蓋了 PCH 和我們的生物製品部門。我不一定會說它過於偏重於該細分市場的 PCH 方面，我認為我們看到 PCH 的大部分影響與消費者信心有關，鑑於我們看到的宏觀經濟通脹環境，可自由支配支出，這會產生更直接的影響，尤其是對製藥業——抱歉，在企業的消費者健康方面，軟糖業務，但也只是——我會說，與非處方藥和消費品相關的軟膠囊業務。

I mentioned in my earlier responses, I think it was to Tejas, about 25% to 35%, I would say, of the revenue call down was related to that consumer confidence or consumer spend dynamic that again is more impactful around the PCH side of the segment. But the remainder, though, is really just in terms of positioning of our customers across both large biologics side as well as the PCH side and their cash-sensitive decisions and just slow down in overall pace around new programs that we're seeing again on the PCH and biologics side. So it's -- part of that is on the PCH side, again, that in addition to the consumer spend gets you to probably a little less than half of the impact being on the PCH side of the business and the rest of it being on the large molecule side.

我在之前的回復中提到過，我認為是對 Tejas，大約 25% 到 35% 的收入下調與消費者信心或消費者支出動態有關，這對 PCH 方面的影響更大段。但是，其餘的實際上只是在我們的客戶在大型生物製劑方面和 PCH 方面的定位以及他們對現金敏感的決定方面，並且只是在我們再次看到的新項目的整體步伐放緩PCH 和生物製劑方面。所以它 - 部分是在 PCH 方面，再一次，除了消費者支出之外，您對業務的 PCH 方面的影響可能還不到一半，其餘的則在大分子側。

Super. That's helpful. If I then focus in biologics, I'm wondering if you might help us to understand how the relative modality growth within biologics is driving that business. You've called out gene therapy a couple of times in your prepared remarks and answers. I guess I'm just wondering like the tech transfers. Do we know -- have you shared with us that those are specifically in sterile fill finish or not? And as we think about kind of the mix of your biologic modalities in '23 versus '22, does that change materially?

極好的。這很有幫助。如果我隨後專注於生物製劑，我想知道您是否可以幫助我們了解生物製劑中的相對模態增長如何推動該業務。你已經在準備好的評論和答案中多次提到基因治療。我想我只是想知道技術轉讓。我們是否知道——您是否與我們分享過那些專門用於無菌灌裝的產品？當我們考慮你在 23 年和 22 年的生物模式組合時，這會發生實質性變化嗎？

I would say it doesn't change materially, Dave. And we have said that the tech transfer programs are going to be meaningful contributors in the second half growth in part of the second quarter, but into the second half growth as they really start to ramp. We have said that those are drug products related and tied to our sterile fill finish assets on past quarters. The comments we made around the first quarter and some of the growth that we've seen on the gene therapy and cell therapy side is expected to continue. So that is a business that saw strong performance in the first quarter grow throughout the fiscal year as well.

我會說它不會發生實質性的變化，戴夫。我們已經說過，技術轉讓計劃將在第二季度的部分時間裡對下半年的增長做出有意義的貢獻，但隨著它們真正開始加速，進入下半年的增長。我們已經說過，這些是與過去幾個季度我們無菌灌裝完成資產相關的藥品。我們在第一季度發表的評論以及我們在基因治療和細胞治療方面看到的一些增長預計將繼續下去。因此，該業務在第一季度的強勁表現在整個財年也有所增長。

So look, Alessandro here. I would tell you that we need to clearly hear is very, very important that we make evaluations on an all-in basis on a non-COVID basis, clearly because biologics is surely the segment that is most impacted by the COVID volume reduction, as you all know, and particularly, the fill and finish side of the business. I will tell you, though, that across all the modalities when you look at them and the prospects of growth ex-COVID on all of them we are pretty excited about the dynamic there, even after our more conservative approach to guidance, which is reflecting some macro factors, which led us to be having a more conservative orientation here. But even with that conservative orientation, we feel very, very excited about the opportunities we see in gene therapy, the expected tipping point for other and also in the tech transfer.

所以看，亞歷山德羅在這裡。我會告訴你，我們需要清楚地聽到非常非常重要的是，我們在非 COVID 的基礎上進行全面評估，因為生物製劑肯定是受 COVID 體積減少影響最大的部分，因為你們都知道，尤其是業務的填充和完成方面。不過，我會告訴你，在所有模式中，當你看到它們以及所有這些模式的增長前景時，我們對那裡的動態感到非常興奮，即使在我們採取更保守的指導方法之後也是如此，這反映了一些宏觀因素，導致我們在這裡有一個更保守的方向。但即使有這種保守的方向，我們對我們在基因治療中看到的機會感到非常、非常興奮，這是對其他領域以及技術轉移的預期轉折點。

So in biologics, it's -- on an ex-COVID basis, we continue to be excited.

因此，在生物製劑中，在前 COVID 的基礎上，我們繼續感到興奮。

Excellent. That's helpful. My last question is around kind of general margin bridge, I guess, goes back to Tejas' question a little bit, but you're taking revenue down, as you said, more conservative. We would normally expect some decrementals in a high fixed cost business. So that is a baseline expectation you also have remediation costs related to the quality issues that you raised in your remarks, inflation and other things that are challenges. Your margin forecast for the new guidance is essentially the same as the old guidance. So I'm looking for help on the cost levers that you're able to pull to mitigate the decremental on the revenue drawdown?

出色的。這很有幫助。我的最後一個問題是關於一般保證金橋的問題，我想，有點回到 Tejas 的問題，但正如你所說，你正在減少收入，更加保守。我們通常預計高固定成本業務會出現一些遞減。因此，這是一個基準預期，您還需要與您在評論中提出的質量問題、通貨膨脹和其他挑戰相關的補救成本。您對新指引的利潤率預測與舊指引基本相同。所以我正在尋求有關成本槓桿的幫助，您可以利用這些成本槓桿來緩解收入下降的遞減嗎？

Yes. No, good question, Dave. And look, I think our margins are looking to be flat this current year in the new guidance in comparison to where they were in the prior year. The cost savings initiatives that we have underway that we've already started to take action. All of those will be operationalized by the end of the calendar year. So we'll be seeing full impacts in the second half of the year related to those. I think the dynamics that we're seeing around the underutilization is certainly playing into the margin situation here in the quarter as is the material piece of the business when we think about the component sourcing side of things. The start-up costs related to Princeton and Oxford ramping up also margin dilutive in the period. But the cost actions that we have underway running the business in a much more efficient way, looking at things from a span and layer standpoint in terms of how we operationalize our large sites are meaningful cost savings actions that we have that we have the ability to utilize here and lever that we absolutely are pulling.

是的。不，好問題，戴夫。看，我認為與去年相比，在新的指導下，我們今年的利潤率看起來與去年持平。我們已經開始採取行動的成本節約計劃。所有這些都將在日曆年年底前投入使用。因此，我們將在下半年看到與這些相關的全面影響。我認為我們看到的圍繞未充分利用的動態肯定會影響本季度的利潤率情況，當我們考慮組件採購方面時，業務的重要部分也是如此。與普林斯頓大學和牛津大學相關的啟動成本上升也在此期間稀釋了利潤。但是，我們正在以更有效的方式運營業務的成本行動，從跨度和層次的角度看待我們如何運營我們的大型網站是有意義的成本節約行動，我們有能力進行利用這里和我們絕對拉動的槓桿。

Our next question is from Julia Qin from JPMorgan.

我們的下一個問題來自摩根大通的 Julia Qin。

This is Amy on for Julia. So I have a follow-up on the CapEx, the slowdown, could you tell me a little bit about which capacity or areas that you guys are cutting down? Like is this a reflection of financial prudence or are you concerned about overcapacity. And the topic related to that is can you also add more colors on the pushout of the Princeton and Oxford plants into 2024?

這是 Amy 為 Julia 準備的。所以我對資本支出進行了跟進，放緩，你能告訴我你們正在削減哪些產能或領域嗎？就像這是對財務審慎的反映，還是您擔心產能過剩。與此相關的話題是，你能否為普林斯頓和牛津工廠的推出添加更多顏色到 2024 年？

Well, sure. Look, I wouldn't call necessarily these cuts in our spend. As we said that this is a rephasing, this is a different timing in which we're going to bring online this capacity. And clearly, our job as the CDMOs is always to keep our utilization rates at reasonable levels to continue to drive margin and as such cash flow. So this is a combination when you look at how much we have brought online, which is on Slide 8, which is a very exciting picture, if you like. in terms of how much we have brought online, which is not COVID-related how many levers we have to continue to drive growth in the industry in areas that continue to be very exciting from a pipeline standpoint. We feel pretty good about what we have already built.

嗯，當然。聽著，我不一定會稱這些削減開支。正如我們所說，這是一個重新調整階段，這是一個不同的時間，我們將在這個時間點將這種能力上線。顯然，我們作為 CDMO 的工作始終是將我們的利用率保持在合理水平，以繼續推動利潤率和現金流。因此，當您查看我們在線帶來了多少時，這是一個組合，在幻燈片 8 上，如果您願意，這是一張非常令人興奮的圖片。就我們在線帶來的數量而言，這與 COVID 無關，我們必須有多少槓桿來繼續推動行業在從管道的角度來看仍然非常令人興奮的領域的增長。我們對我們已經建立的東西感覺很好。

And looking into the future, given our more conservative approach to guidance, we thought it was prudent to slow down a little bit the additional capacity coming online so that we could keep the level of absorption as expected, but also not to jeopardize the long-term growth prospects of the company. So this all results in a fiscally prudent approach, which I believe given the environment is the right thing to do.

展望未來，鑑於我們對指導的態度更為保守，我們認為謹慎的做法是稍微放慢上線的額外容量，以便我們能夠保持預期的吸收水平，但也不危及長期-公司長期發展前景。因此，這一切都導致了財政上的審慎做法，我相信鑑於環境是正確的做法。

I have one question, and then I'll hop off. can you share some visibility about the non-COVID based business ramp into the 2023 under new guidance, especially in the biologics sectors. Like what percentage of the revenue will come from customers that stick around after COVID and what supports your confidence into the rest of the year, the second half of the year?

我有一個問題，然後我會跳下。您能否分享一些關於在新指導下進入 2023 年的非 COVID 業務的可見性，尤其是在生物製品領域。比如有多少百分比的收入將來自在 COVID 之後留下來的客戶，以及是什麼支持你對今年剩餘時間、下半年的信心？

So look, we're very pleased with the start we had fiscal '21 here on a non-COVID basis. We mentioned on Alessandro's prepared remarks as we mine that we saw more than 20% growth across the company on a non-COVID basis in the first quarter. Our guidance assumes we continue to see growth around those levels. We haven't disclosed what the split out will be between the Pharma and Consumer Health side of the business versus that of the biologics side of the business, but many of the growth drivers we have do -- are related to modalities that were not impacted by COVID-related volumes. Just think about the cell and gene therapy strength that we saw in the first quarter. And that the expectation is that, that continues here into the second half of the fiscal year. So again, we're just really looking at things to continue to trend on a non-COVID basis, in line with what we saw in the first quarter in the more conservative view of our guidance that we presented today.

所以看，我們對我們在非 COVID 的基礎上擁有 21 財年的開始感到非常滿意。我們在 Alessandro 準備好的評論中提到，我們在第一季度看到整個公司在非 COVID 的基礎上增長了 20% 以上。我們的指導假設我們繼續看到這些水平附近的增長。我們尚未披露製藥和消費者健康業務與生物製劑業務之間的拆分情況，但我們所做的許多增長驅動力都與未受影響的模式有關按與 COVID 相關的數量。想想我們在第一季度看到的細胞和基因治療實力。並且期望是，這種情況一直持續到本財年的下半年。再說一次，我們只是真的在考慮在非 COVID 的基礎上繼續趨勢的事情，這與我們在第一季度在我們今天提出的更保守的指導觀點中看到的一致。

Our next question is from Derik De Bruin from Bank of America.

我們的下一個問題來自美國銀行的 Derik De Bruin。

So I've got a few here. Can you just elaborate a little bit more on what you mean by the slowdown in pacing, the started programs. I would assume it's not still finished. We did more drug substance and then on the consumer side, just what you're seeing? Just a little bit more color around what exactly and where it's been impacted?

所以我這裡有幾個。您能否詳細說明一下您所說的節奏放緩、已啟動的程序是什麼意思。我會假設它還沒有完成。我們做了更多的藥物，然後在消費者方面，你看到了什麼？只是在它受到影響的確切位置和位置周圍增加一點顏色？

So Derik, I would say it's really very widespread. I mean we're seeing it, as I mentioned, not only in the biologics side of the business, but on the Pharma and Consumer Health side. We're seeing it across both commercial products where customers are willing to appear to manage the supply chain to a more conservative level here and not run on the same levels of inventory here as they look to manage working capital. But I would say that the pace is more around some of the development programs that we have now. Phase III programs that are full blown into clinical trial activity are not the types of programs that we're talking about here. But we have plenty of programs across the network, both on the Biologics and PCH side in development, but I would say in that Phase II range where we are seeing maybe some tempered expectations in terms of the pace in which customers are moving through there as they look to potentially manage their care situation.

所以德里克，我想說它真的非常普遍。我的意思是，正如我所提到的，我們不僅在業務的生物製劑方面，而且在製藥和消費者健康方面都看到了它。我們在這兩種商業產品中都看到了這一點，客戶願意在這裡將供應鏈管理到更保守的水平，而不是在他們希望管理營運資金時使用相同水平的庫存。但我想說的是，我們現在擁有的一些發展計劃的步伐更多。全面開展臨床試驗活動的 III 期項目不是我們在這裡討論的項目類型。但是我們在整個網絡上有很多項目，包括生物製劑和 PCH 方面的開發，但我想說的是，在第二階段範圍內，我們可能看到客戶在其中移動的速度方面可能會出現一些緩和的期望，因為他們希望有可能管理他們的護理情況。

So again, going back to comments I made earlier, really across both Pharma and Consumer Health and against the commercial products and development side of things. So just a more conservative approach to guidance from our standpoint is necessary based on some of these trends we're seeing across the customer base.

再說一次，回到我之前發表的評論，實際上涉及製藥和消費者健康以及商業產品和事物的開發方面。因此，根據我們在整個客戶群中看到的一些趨勢，從我們的角度來看，有必要採取更保守的指導方法。

Okay. And a couple of just housekeeping questions. So what is, given the new debt and the increased interest rates, what is your expectation for net interest expense for the year? How big is your macro sensitive, which you would consider macro sensitive, portion of the business, particularly on macro side?

好的。還有幾個只是家政問題。那麼，鑑於新債務和利率上升，您對今年的淨利息支出有何預期？您的宏觀敏感度（您認為宏觀敏感度）業務的一部分有多大，尤其是在宏觀方面？

Sure. So the slide in the deck has a good view of the capital structure, Derik, for you to take a look at, I would say, about 25% of our debt when you take into consideration the debt that's been borrowed on the revolver to fund the Metrics acquisition is floating and more tied to the rising interest rate environment with about 75% of that being considered fixed. So hopefully, that could be helpful as you look to model this.

當然。所以甲板上的幻燈片很好地了解了資本結構，德里克，讓你看看，我想說，當你考慮到左輪手槍上借來的債務來資助時，我們大約 25% 的債務對 Metrics 的收購是浮動的，更多地與不斷上升的利率環境相關，其中約 75% 被認為是固定的。因此，希望這對您進行建模時會有所幫助。

Okay. And do you feel like you've appropriately de-risked COVID enough? The COVID exposure for this year?

好的。你覺得你已經適當地降低了 COVID 的風險嗎？今年的新冠病毒暴露情況？

I would say there's been very little change to our assumptions around COVID, just given the contractual obligations that we have. Here much more of the call down was related to non-COVID business and the macroeconomic environment that we're in here. So nothing else to note around the COVID side of things.

我想說的是，考慮到我們所承擔的合同義務，我們對 COVID 的假設幾乎沒有變化。在這裡，更多的呼籲與非 COVID 業務和我們所處的宏觀經濟環境有關。因此，在 COVID 方面沒有其他需要注意的地方。

Our next question is from Max Smock from William Blair.

我們的下一個問題來自 William Blair 的 Max Smock。

Just the first one for me here. You've called out a number of factors really behind the reduced guide for this year. But one of the things we haven't touched on is the ability for you to change over from COVID to non-COVID work and whether or not that factored into the results in the quarter as well as your outlook for the year. So just trying to get a sense for whether or not this transition has maybe been a little harder than you expected or it's part of the issue here? Or if you've been able to kind of make that shift in line with your expectations?

對我來說只是第一個。您已經指出了今年減少指南背後的許多因素。但是，我們沒有涉及的一件事是您能夠從 COVID 工作轉變為非 COVID 工作，以及這是否會影響本季度的結果以及您對今年的展望。因此，只是想了解一下這種過渡是否比您預期的要困難一些，或者這是否是問題的一部分？或者，如果你已經能夠按照你的期望做出這種轉變？

No, look, Alessandro here. Look, as we said multiple times, most of the non-COVID work is executed on assets, which are unrelated to the COVID execution. So the two things that don't tend to interfere with each other. As we have said, even the settlement we reached into the quarter was something that was somewhat planned for. And so given our approach that we shared multiple times, that our approach is holistic and looking at the partnership with important customers, which have much more than just COVID relationship with us. So I wouldn't say that this has had any interference with our ability to execute on the non-COVID work.

不，看，亞歷山德羅在這裡。看，正如我們多次說過的，大部分非 COVID 工作是在資產上執行的，這些資產與 COVID 執行無關。所以這兩件事不會相互干擾。正如我們所說，即使是我們在本季度達成的和解也是有些計劃好的。因此，鑑於我們多次分享的方法，我們的方法是全面的，並著眼於與重要客戶的合作關係，這些客戶與我們的關係遠不止新冠病毒。所以我不會說這對我們執行非 COVID 工作的能力有任何干擾。

And look, I always go back to the point that in our Q1, we were able to deliver a non-COVID growth of 20% plus, which is a remarkable performance.

看，我總是回到這一點，在我們的第一季度，我們能夠實現 20% 以上的非 COVID 增長，這是一個了不起的表現。

Got it. That's helpful. So as a follow-up, I mean, one of the things you mentioned last quarter was that non-COVID growth benefited a little bit from some backlog going to the system related to some projects that maybe had suffered a little bit as you prioritized COVID. Just wondering if there's any way to quantify whether or not this had an impact in the quarter? And if so, is it -- is the backlog now largely work through? Or should we expect this kind of to be somewhat of a tailwind, I guess, of the business throughout fiscal 2023.

知道了。這很有幫助。因此，作為後續行動，我的意思是，你在上個季度提到的一件事是，非 COVID 增長從一些積壓到與一些項目相關的系統中受益，這些項目可能在你優先考慮 COVID 時受到了一些影響.只是想知道是否有任何方法可以量化這是否對本季度產生了影響？如果是這樣，是不是 - 現在積壓的工作基本上已經解決了？或者我們是否應該期望這種情況在整個 2023 財年對業務產生某種推動作用。

Well, there are some areas where we continue to be a little bit capacity constrained when you look at the demand. So I would say that overall the backlog in terms of demand that we need to still treat out has not change dramatically in terms of the picture. There are maybe some areas of the business where we are seeing even more success than what we anticipated in terms of demand like I named Zydis as one notable item in our business where we are trying to build additional capacity at speed. But I would say overall the backlog situation has not changed dramatically.

好吧，當您查看需求時，我們在某些領域仍然會受到一些產能限制。所以我想說，總體而言，我們仍然需要處理的積壓需求並沒有顯著變化。在需求方面，我們可能在某些業務領域看到了比我們預期的更大的成功，例如我將 Zydis 命名為我們業務中的一個值得注意的項目，我們正在努力快速建立額外的容量。但我想說總體而言，積壓情況並沒有發生巨大變化。

(Operator Instructions)

（操作員說明）

Our next question is Justin Bowers from Deutsche Bank.

我們的下一個問題是德意志銀行的賈斯汀鮑爾斯。

Just on the settlement you described. Is that a good kind of quarterly run rate that we should assume with the exception of kind of like the true-up that you're going to have in 2Q? And then the comments on reduced utilization, is that -- how does that split between Biologics and PCH. It seems like it's more weighted to PCH. And then on PCH, what's kind of like lead time for lots of discretionary? And I'll stop there.

就在你描述的定居點上。這是我們應該假設的一種好的季度運行率，除了你將在第二季度進行的那種真實情況嗎？然後是關於降低利用率的評論是 - Biologics 和 PCH 之間是如何劃分的。似乎它對 PCH 的影響更大。然後在 PCH 上，很多可自由支配的交貨時間是什麼樣的？我會停在那裡。

So just to take your comment, Justin, around the timing of COVID-related to the settlement. So there's no quarterly phasing here that I would read into the recognition related to this in terms of run rate. This was a settlement related to one customer. As you know, there are two major customers in which we have COVID-related volumes for here. I will say the comments I made are that the COVID-related headwind that we see during fiscal '23 is going to be more pronounced in the second quarter than it was in the first quarter. And I would say it will be equally as pronounced in the third quarter. Our second and third quarters are the quarters in which we were most -- where we're most expected to see COVID-related volume declines as we head through the fiscal year.

因此，賈斯汀，只是想就與和解相關的 COVID 時間發表您的評論。因此，這裡沒有季度分階段，我會在運行率方面閱讀與此相關的認可。這是與一位客戶有關的和解。如您所知，我們在這里為兩個主要客戶提供與 COVID 相關的捲。我會說我所做的評論是，我們在 23 財年看到的與 COVID 相關的逆風在第二季度將比第一季度更加明顯。我會說它在第三季度同樣明顯。我們的第二和第三季度是我們工作最多的季度——隨著我們進入本財年，我們最預計會看到與 COVID 相關的交易量下降。

In terms of the comment related to capacity utilization, I would say as you look at the slide on the materials here on Slide 8, where we talk about new capacity that has come online or is in the process of coming online. Many of those are biologics-related assets. So the assumption that some of the underutilization and capacity that we're going to see in fiscal '23, which we've alluded to before, given the timing of bringing on this new capacity as well as the ramping associated with starting to fill that is much more of a biologics dynamic than it is a Pharma and Consumer Health dynamic.

關於與產能利用率相關的評論，我想說的是，當您查看幻燈片 8 上的材料幻燈片時，我們討論了已上線或正在上線的新產能。其中許多是與生物製品相關的資產。因此，假設我們將在 23 財年看到的一些未充分利用和產能，我們之前已經提到過，考慮到引入新產能的時機以及與開始填補該產能相關的斜坡與製藥和消費者健康動態相比，它更像是一種生物製劑動態。

Our next question is from Jacob Johnson from Stephens.

我們的下一個問題來自斯蒂芬斯的雅各布約翰遜。

This is Mac on for Jacob. Just a quick question for me. As it relates to your cell and gene therapy business, I think you have at least one commercial customer and another potentially coming. How should we think about the size of a given commercial cell and gene therapy customer or looking at it in another way, what is the potential revenue capacity of suite at BWI?

這是雅各布的 Mac。對我來說只是一個快速的問題。由於它與您的細胞和基因治療業務有關，我認為您至少有一個商業客戶，另一個可能會來。我們應該如何考慮給定的商業細胞和基因治療客戶的規模，或者換個角度來看，BWI 套件的潛在收入能力是多少？

So you can't look at the suites at BWI on a revenue basis. No programs are equal. There's a lot of different things, I would say, that factor into how you would look at the potential revenue here. I think your comments are spot on. We have had a commercially approved program. We have several programs that I would say are in later stage. I think you're probably referring to one specific.

因此，您不能根據收入來查看 BWI 的套房。沒有程序是平等的。我想說，有很多不同的因素會影響你如何看待這裡的潛在收入。我認為你的評論是正確的。我們有一個商業批准的程序。我們有幾個計劃，我會說它們處於後期階段。我想你可能指的是一個特定的。

Look, I think that continues to be a meaningful customer for us. It assumes in our guidance in fiscal '23 that it will continue to be. And it's difficult to comment on any specific customer or individual programs as well as the revenue I would say, attached to it. But the progress of the pipeline that we have within gene therapy, the fact that we've been investing here to bring on additional suites, which will have 18 suites here as we get through fiscal '23, up and running as well as 150 different development programs that we have on the gene therapy side of the business here. So a very robust pipeline that continues to mature.

看，我認為這對我們來說仍然是一個有意義的客戶。它假設我們在 '23 財年的指導中將繼續如此。很難評論任何特定的客戶或個別項目以及我想說的附加收入。但是我們在基因治療方面的管道進展，我們一直在這裡投資以引進更多套房的事實，當我們度過 23 財年時，這裡將有 18 套套房，以及 150 套不同的套房我們在基因治療方面的業務發展計劃。因此，一個非常強大的管道將繼續成熟。

So I just would add a more helicopter view. We believe that our BWI asset within suite will be one of the largest, if not the largest viral vector factoring asset out there. And that clearly is going to be a meaningful contributor of our growth story in the next few years given also the strength of the pipeline that we're seeing with the customers progressing to late stage and potential approval.

所以我只想添加更多直升機視圖。我們相信，我們在套件中的 BWI 資產將是最大的病毒載體因子資產之一，如果不是最大的話。這顯然將成為我們未來幾年增長故事的重要貢獻者，同時考慮到我們看到的客戶進入後期階段和潛在批准的管道實力。

Our next question is from John Sourbeer from UBS.

我們的下一個問題來自瑞銀的 John Sourbeer。

Maybe just one here and some of the comments you mentioned on the inflationary pressures and the updated guide. Are you -- can you talk a little bit just on pricing and are you starting to see now more pushback from customers maybe more specific on biotech customers on some of the price increases with the inflationary pressures in the market?

也許這裡只有一個，以及你提到的關於通脹壓力和更新指南的一些評論。你是不是 - 你能談談定價嗎？你現在是否開始看到來自客戶的更多阻力，也許更具體地針對生物技術客戶，因為市場通脹壓力導致價格上漲？

Yes, sure. Look, I do believe that we have been successful in levering the price as appropriate. Clearly, it's not a one size fits all around the different offerings. There are different market positions. Clearly, on your more commercial business, where you have long-standing contracts and there are mechanisms and relationships and so forth. It tends to be more easier and more aggressive stand on the other places where you are competing to win business, you really need to be careful around where the market is going. But we have a very good pulse of what are the areas of opportunities, and we are doing everything we can on every other opportunity there to make sure that we offset as much as we can at the inflationary pressure that we are seeing.

是的，當然。看，我確實相信我們已經成功地適當地利用了價格。顯然，它不是一種適合所有不同產品的尺寸。有不同的市場定位。顯然，在您的商業化業務中，您有長期合同，並且存在機制和關係等等。在您競爭贏得業務的其他地方往往更容易和更積極地站立，您確實需要小心市場的走向。但我們對機會領域有很好的把握，我們正在盡我們所能抓住所有其他機會，以確保我們盡可能多地抵消我們所看到的通脹壓力。

Our next question is from Jack Meehan from Nephron Research.

我們的下一個問題來自 Nephron Research 的 Jack Meehan。

Alessandro or Tom, can you provide color on cancellations? How are they in the quarter relative to historical periods?

亞歷山德羅或湯姆，你能提供取消的顏色嗎？與歷史時期相比，他們在本季度的情況如何？

So look, I wouldn't say we've seen much in the way of cancellations in the current quarter here. That wasn't an impact of the results in first quarter. I would say we've seen a handful of cancellations as we think about the remainder of the fiscal year, but I wouldn't necessarily say it's any different than what we're seeing -- than what we've seen historically. I would say though, the overall progression of not things that are being canceled, but just the pace in which customers are willing to move is where we're seeing the slowdown, right? So this is in programs that are at are being necessarily canceled, but certainly a slowdown and that slowdown both on the Pharma and Consumer Health side as well as the biologics side was what was contemplated in the more conservative view of guidance.

所以看，我不會說我們在本季度看到了很多取消的方式。這不是第一季度業績的影響。我想說，當我們考慮本財年的剩餘時間時，我們已經看到了一些取消，但我不一定會說這與我們所看到的 - 與我們歷史上所看到的有任何不同。不過，我想說的是，不是被取消的事情的整體進展，而是客戶願意移動的速度是我們看到放緩的地方，對嗎？因此，這是在必須取消的計劃中，但肯定會放緩，而且製藥和消費者健康方面以及生物製劑方面的放緩是更保守的指導觀點所考慮的。

Yes. Look, I would call it more selectivity, right Selectivity on both side, outside the customer side in terms of understanding how we're going to progress the business going forward given the cash situation.

是的。看，我會稱之為更多的選擇性，對雙方的選擇性，在客戶方面之外，在了解我們將如何在現金情況下推進業務方面。

Our next question is from Evan Stover from Baird.

我們的下一個問題來自 Baird 的 Evan Stover。

Yes. I want to make sure I understand how consumer spending habits actually impact your business. So earlier in the question and answer, you said that the change in consumer spending was about 30% of the guidance cut or my math, that's about $100 million. And also, if I look at what that would relate to your consumer health and OTC business is about a $700 million business in fiscal '22, I guess, $800 million, if I fully impacted with Bettera. I mean I just put those two together and it's a $100 million cut on a $700 million or $800 million business. It's strong double-digit impact for that business for a change in consumer spending behavior, which seems like a big change in end market demand. So I just want to make sure I really understand how that consumer spending impacts your business?

是的。我想確保我了解消費者的消費習慣如何真正影響您的業務。所以在問答的前面，你說消費者支出的變化大約是指導削減的 30%，或者我的數學，大約是 1 億美元。而且，如果我看一下這與您的消費者健康和非處方藥業務相關的內容，在 22 財年大約是 7 億美元的業務，我猜，如果我對 Bettera 產生了全面的影響，則為 8 億美元。我的意思是我只是把這兩者放在一起，這對 7 億美元或 8 億美元的業務來說是 1 億美元的削減。消費者支出行為的變化對該業務產生了兩位數的強大影響，這似乎是終端市場需求的重大變化。所以我只是想確保我真正了解消費者支出如何影響您的業務？

Well, look, I would refer to Tom more on the specifics. I can tell you that you don't have to look at these only on a market demand standpoint, right? There are, at times, two compounding effects. One is the end market and the other one is the stock levels. And there are temporary demand -- our demand is the combination of the [entity mark] and how much inventory our customers want to carry about each individual offering. And clearly, when there is more uncertainty and surely the orientation towards the end market demand tends to be a little bit lower than is surely in a capital tight market as we are running today, there is more a conservative approach, how much inventory you want to carry. So these are -- the inventory piece is a temporary effect that tends to balance off in a few months period because at some point, once the destocking has happened, you're really serving the end market demand. But I believe these are the two effects that compounded probably explain better the dynamic around your question.

好吧，看，我會更多地參考湯姆的細節。我可以告訴你，你不必只從市場需求的角度來看這些，對吧？有時，有兩種複合效應。一個是終端市場，另一個是庫存水平。還有暫時的需求——我們的需求是[實體標記]和我們的客戶想要為每個單獨的產品攜帶多少庫存的組合。很明顯，當存在更多不確定性並且終端市場需求的方向肯定會比我們今天運行的資本緊縮市場肯定要低一些時，有更保守的方法，你想要多少庫存攜帶。所以這些是 - 庫存是一種暫時的影響，往往會在幾個月內平衡，因為在某個時候，一旦發生去庫存，你真的在為最終市場需求服務。但我相信這兩種影響可能會更好地解釋圍繞您的問題的動態。

Our last question today is from Luke Sergott from Barclays.

我們今天的最後一個問題來自巴克萊的 Luke Sergott。

So as you think about the -- can you guys give us a sense of the guidance methodology and how you guys factor in potential approvals from some of those cell and gene therapy businesses? And then can you give us a sense of -- or just give us a size of the business of cell and gene therapy and how that's been growing?

因此，當您考慮 - 你們能否讓我們了解指導方法以及你們如何考慮某些細胞和基因治療業務的潛在批准？然後你能給我們一個感覺——或者只是給我們一個細胞和基因治療業務的規模，以及它是如何增長的？

So sure, Luke. I'll give you some directional color here. Look, we haven't quantified the cell and gene therapy business in terms of its size, but I'll rank our revenue contributors biologics overall here, and I would definitely dissect both cell and gene therapy because they are very -- two very different businesses at different stages of maturity. Our drug product business around Biologics is our largest revenue contributor here. But our gene therapy, I would say, is a close second to that in service of its contributions to the $2.5 billion of biologics revenue that we would have annually. I would say from there, it's our drug substance business and then our cell therapy and then you start getting into some smaller revenue contributions from plasma DNA, IPSCs, et cetera, out here.

很確定，盧克。我會在這裡給你一些方向性的顏色。看，我們還沒有量化細胞和基因治療業務的規模，但我將在這裡對我們的收入貢獻者生物製劑進行整體排名，我肯定會剖析細胞和基因治療，因為它們非常 - 兩個非常不同處於不同成熟階段的企業。我們圍繞生物製品的藥品業務是我們最大的收入貢獻者。但我想說，我們的基因療法在為我們每年將獲得的 25 億美元生物製劑收入做出的貢獻方面緊隨其後。我會說從那裡開始，這是我們的藥物業務，然後是我們的細胞療法，然後你開始從血漿 DNA、IPSC 等獲得一些較小的收入貢獻。

So our gene therapy is the #2 contributor to overall biologics revenue in terms of absolute dollars. It's the area where we're seeing fastest growth right now for sure, and a big reason of why we saw the growth we did in the first quarter across the company of more than 20% on a non-COVID basis.

因此，以絕對美元計，我們的基因療法是整體生物製品收入的第二大貢獻者。毫無疑問，這是我們目前看到增長最快的領域，也是我們看到第一季度在非 COVID 基礎上整個公司增長超過 20% 的一個重要原因。

In terms of assumptions here, look, we're not going to take an overly aggressive approach to regulatory approvals, which are outside of our control, and in many cases -- in most cases, outside of our customers' control as well. So we're not assuming any significant impacts from commercial approval down the road here that factors into us being able to achieve our guidance, especially a guidance that's been built now with a much more conservative orientation than what we have previously had discussed.

就這裡的假設而言，看，我們不會對監管批准採取過於激進的方法，這超出了我們的控制範圍，而且在許多情況下——在大多數情況下，也超出了我們客戶的控制範圍。因此，我們不會假設未來商業批准會產生任何重大影響，這會影響我們能夠實現我們的指導，特別是現在建立的指導比我們之前討論的要保守得多。

Maybe I'll add just one comment in terms of adding additional color to the dynamics here. You need to think about the potential commercial approval. Not only is a dynamic to serve the commercial approval, but there is also a dynamic that precedes that is a more launch stock build-out, which you do normally for sizable approvals on which we have a little bit more confidence around what the impact could be.

也許我會在這裡添加一條關於為動態添加額外顏色的評論。您需要考慮潛在的商業批准。不僅是為商業批准服務的動力，而且在此之前還有一個動力是增加更多的發射庫存，您通常會這樣做以獲得相當大的批准，我們對可能產生的影響更有信心是。

So with that said, I would like to wrap up the call. I guess, we are done with questions. So thanks, everyone, for taking the time today to join our call and for your continued support of Catalent. Thank you, everybody.

話雖如此，我想結束通話。我想，我們已經完成了問題。因此，感謝大家今天抽出時間加入我們的電話會議，並感謝您對 Catalent 的持續支持。謝謝大家。

Thank you, everyone, for joining today's call. You may now disconnect your lines, and have a lovely day.

謝謝大家加入今天的電話會議。您現在可以斷開線路，度過愉快的一天。