Catalent Inc (CTLT) 2024 Q1 法說會逐字稿

Hello all, and welcome to Catalent's First Quarter Fiscal Year 2024 Earnings Call. My name is Lydia, and I will be your operator today. (Operator Instructions)

大家好，歡迎參加 Catalent 2024 財年第一季財報電話會議。我叫莉迪亞，今天我將成為你們的接線生。 （操作員說明）

I'll now hand you over to your host, Paul Surdez, Vice President of Investor Relations, to begin. Please go ahead.

現在我將把您交給東道主投資者關係副總裁保羅·蘇爾德茲 (Paul Surdez) 開始。請繼續。

Good morning, everyone, and thank you all for joining us today to review Catalent's preliminary first quarter 2024 financial results. Joining me on the call are John Greisch, Executive Chair of the Board; Alessandro Maselli, President and Chief Executive Officer; and Matti Masanovich, Senior Vice President and Chief Financial Officer.

大家早安，感謝大家今天與我們一起回顧康泰倫特 2024 年第一季的初步財務表現。與我一起參加電話會議的還有董事會執行長 John Greisch；亞歷山德羅‧馬塞利 (Alessandro Maselli)，總裁兼執行長；以及高級副總裁兼財務長馬蒂·馬薩諾維奇 (Matti Masanovich)。

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, including as a result of the finalization of Catalent's fiscal 2023 and first quarter fiscal 2024 financial statements.

在今天的電話會議中，管理階層將做出前瞻性陳述並參考非公認會計準則財務指標。未來的結果可能與管理階層的預期有所不同，包括康泰倫特 2023 財年和 2024 財年第一季財務報表最終確定的結果。

Please refer to Slide 2 of 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. Please also refer to Catalent's annual report on Form 10-K for the year ended June 30, 2022, as amended; Catalent's quarterly report on Form 10-Q for the 3 and 9 months ended March 31, 2023; and our filings with the SEC for additional information of certain of the risks and uncertainties that may bear on our operating results, performance and financial condition.

請參閱我們的投資者關係網站Investor.catalent.com 上提供的補充簡報的幻燈片2，以了解可能導致實際業績或結果與這些前瞻性陳述和幻燈片3 所建議的內容不同的風險和不確定性的討論4 討論了 Catalent 使用非 GAAP 財務指標的情況。另請參閱康泰倫特截至 2022 年 6 月 30 日止年度的 10-K 表格年度報告（經修訂）； Catalent 截至 2023 年 3 月 31 日的 3 個月和 9 個月的 10-Q 表格季度報告；以及我們向 SEC 提交的文件，以獲取可能對我們的經營業績、業績和財務狀況產生影響的某些風險和不確定性的更多資訊。

Now I would like to turn the call over to John for some brief opening remarks before handing it to Alessandro. Commentary for these 2 presenters is covered on Slide 5.

現在我想將電話轉交給約翰，他會做一些簡短的開場白，然後再交給亞歷山德羅。幻燈片 5 涵蓋了這兩位演講者的評論。

Thank you, Paul. Good morning, and thanks for joining us today. Before I turn the call over to Alessandro, I want to share a few comments on the quarter and on the progress our management team and strategic and operational review committee have made over the past 2.5 months toward achieving our goals.

謝謝你，保羅。早安，感謝您今天加入我們。在將電話轉給 Alessandro 之前，我想就本季度以及我們的管理團隊以及策略和營運審查委員會在過去 2.5 個月中為實現我們的目標所取得的進展分享一些評論。

As you saw in the earnings release and will hear further from Alessandro, we have delivered a solid first quarter and are confirming our full year guidance. Given the turmoil in many of our markets, we are pleased on both fronts. In addition, Matti and his team have brought a renewed focus on cash flow, and we are encouraged by already seeing benefits from improved working capital management and greater analytical rigor around CapEx spend thus far in the year.

正如您在財報中看到的那樣，並將從亞歷山德羅那裡聽到更多信息，我們第一季的業績表現強勁，並正在確認我們的全年指導。鑑於我們許多市場的動盪，我們對這兩方面都感到滿意。此外，馬蒂和他的團隊重新關注現金流，我們已經看到今年迄今為止改善的營運資本管理和更嚴格的資本支出分析所帶來的好處，這讓我們感到鼓舞。

I want to reiterate that we expect to catch up on our fiscal 2023 and first quarter 2024 SEC filings later this month. We've been working tirelessly to finalize these documents over the last couple of months. Matti will go into additional detail on this topic later in today's call.

我想重申，我們預計將在本月稍後向 SEC 提交 2023 財年和 2024 年第一季的文件。在過去的幾個月裡，我們一直在不懈地努力最終完成這些文件。馬蒂將在今天的電話會議中進一步詳細討論該主題。

Finally, I'd like to comment on the work underway by the Board's strategic and operational review committee. As you will recall, we formed the committee at the end of August to conduct a thorough review of our businesses, strategies, operations and capital allocation priorities with a view towards maximizing the long-term value of the company. Since then, the committee has made progress identifying and evaluating a number of options to maximize long-term value creation for shareholders.

最後，我想對董事會策略和營運審查委員會正在進行的工作發表評論。您可能還記得，我們​​在八月底成立了委員會，對我們的業務、策略、營運和資本配置優先事項進行徹底審查，以期實現公司長期價值最大化。自那時起，該委員會在確定和評估一系列選項方面取得了進展，以最大限度地為股東創造長期價值。

We continue to work closely with Elliott as we thoroughly evaluate these strategic options, and we look forward to sharing a more detailed update with all of you at a later date.

我們將繼續與 Elliott 密切合作，全面評估這些策略選擇，並期待稍後與大家分享更詳細的更新資訊。

Let me wrap up by emphasizing that the entire Catalent team is working hard to execute against our strategic plans in order to improve performance and create value. As you will hear today, we are confident in the value of opportunities that lie ahead and are pleased that our first quarter performance puts us on track to realize our 2024 plans.

最後，我要強調整個 Catalent 團隊正在努力執行我們的策略計劃，以提高績效並創造價值。正如您今天將聽到的，我們對未來機會的價值充滿信心，並且很高興我們第一季的業績使我們走上了實現 2024 年計劃的軌道。

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

說到這裡，我想把電話轉給亞歷山德羅。

Thank you, John. Good morning, everyone. I'm proud of the work the Catalent team has done to deliver a strong start to our fiscal year '24. We delivered a solid financial performance in the first quarter, including 5% non-COVID revenue growth while also progressing on all fronts with our operational improvements. I echo John's confidence in our plan, and I'm pleased to reaffirm our fiscal '24 guidance today.

謝謝你，約翰。大家，早安。我對 Catalent 團隊為我們 24 財年的良好開端所做的工作感到自豪。我們在第一季實現了穩健的財務業績，包括 5% 的非新冠疫情收入成長，同時我們的營運改善也在各方面取得了進展。我同意約翰對我們計劃的信心，我很高興今天重申我們的 24 財年指導方針。

While the macro headwinds that we started to call out in November of last year are still present, the strength of our pipeline is bearing fruit, allowing us to continue to guide to a mid- to high-teens revenue growth rate this year when excluding COVID-related revenue. Key factors underpinning our confidence include: Continued high demand for our gene therapy services, expanded exposure to GLP-1 demand as we bring up more lines and a very strong rate of new approvals that we have seen in the Pharma and Consumer Health segment in this calendar year.

雖然我們去年11 月開始指出的宏觀逆風仍然存在，但我們的管道實力正在結出碩果，使我們能夠在排除新冠疫情影響的情況下，繼續引導今年的收入增長率達到中雙位數至高雙位數。相關收入。支撐我們信心的關鍵因素包括：對我們的基因治療服務的持續高需求、隨著我們推出更多產品線而擴大的GLP-1 需求以及我們在製藥和消費者健康領域看到的非常強勁的新核准率公曆年。

We continue to address underutilization at some of our new facilities, bolster our commercial efforts to accelerate new business wins and reduce our capital deployment in affected areas, all while focusing our CapEx on projects that leverage high-demand areas.

我們繼續解決一些新設施利用率不足的問題，加強我們的商業努力，以加速新業務的贏得，並減少我們在受影響地區的資本部署，同時將我們的資本支出集中在利用高需求地區的項目上。

We also made the measurable progress in implementing operational improvements in our Biologics segment, resulting in favorable performance trends over the last few months and a quarterly sequential 1,400 basis points improvement in EBITDA margin. We are committed to demonstrating what we believe is our unrivaled ability to run the best drug development and manufacturing facilities in the world, both to our investors and our customers.

我們在實施生物製劑業務營運改善方面也取得了顯著進展，在過去幾個月中實現了良好的業績趨勢，並且每季 EBITDA 利潤率環比提高了 1,400 個基點。我們致力於向我們的投資者和客戶展示我們認為營運世界上最好的藥物開發和生產設施的無與倫比的能力。

To help us achieve these goals, we recently appointed David McErlane as the Group President of our Biologics segment. David, previously SVP of Lonza's bioscience business, is a seasoned and highly successful business leader with a record of developing winning strategies that drive growth and create significant value. We are energized by the immediate positive impact he's already making on the business.

為了幫助我們實現這些目標，我們最近任命 David McErlane 為生物製劑部門的集團總裁。 David 曾任 Lonza 生物科學業務資深副總裁，是一位經驗豐富且非常成功的商業領袖，擁有製定推動成長和創造重大價值的致勝策略的記錄。他對業務所產生的直接正面影響讓我們深受鼓舞。

In Biologics, we have seen the impact of operational enhancement and strong commercial demand on our financial results. In the first quarter, our drug product business in Brussels and our gene therapy business in BWI each had a strong year-over-year and sequential growth as well as margin improvements. As you know, the BWI facility serves multiple programs for our largest customer, Sarepta, as well as many programs for other customers.

在生物製品領域，我們看到了營運增強和強勁的商業需求對我們財務表現的影響。第一季度，我們在布魯塞爾的藥品業務和在 BWI 的基因治療業務均實現了強勁的同比和環比增長以及利潤率改善。如您所知，BWI 設施為我們最大的客戶 Sarepta 提供多個項目，也為其他客戶提供許多項目。

Our pipeline for gene therapy is healthy, including several programs in late stage, one of which was recently signed. As a reminder, the late-stage programs are generally insulated from softness in the biotech funding environment.

我們的基因治療管道狀況良好，包括多個處於後期階段的項目，其中一個項目最近已簽署。需要提醒的是，後期專案通常不會受到生物技術融資環境疲軟的影響。

Our world-class team continues to ramp operations and work around the clock to meet Sarepta's demand and manufacturing goals. Sarepta has recently confirmed their scale-up plans for calendar 2024, firming up orders. And we expect revenue from these top customers to grow approximately 65% this fiscal year as we manufacture product for the U.S. market and the rest of the world to Sarepta and these partners.

我們的世界級團隊持續提高營運水準並全天候工作，以滿足 Sarepta 的需求和製造目標。 Sarepta 最近確認了 2024 年的擴大計劃，以確認訂單。我們預計，隨著我們為美國市場和世界其他地區的 Sarepta 和這些合作夥伴生產產品，本財年來自這些頂級客戶的收入將增長約 65%。

Additionally, I'm very pleased with the progress we are making on our working capital initiatives, including contract assets, of which Matti will provide additional details.

此外，我對我們在營運資本計劃（包括合約資產）方面取得的進展感到非常滿意，馬蒂將提供更多詳細資訊。

In Bloomington, we continue to improve operational performance and we ramp up the assets needed to satisfy demand across multiple new products, including GLP-1s. As a result of these multisite progress, we expect to exit the fiscal '24 with a more normalized pre-pandemic margins in the Biologics segment.

在布魯明頓，我們不斷提高營運績效，並增加所需資產以滿足多種新產品（包括 GLP-1）的需求。由於這些多地點的進展，我們預計在 24 財年結束時，生物製劑領域的疫情前利潤率將更加正常化。

Moving to Pharma and Consumer Health. This segment delivered the first quarter in line with our expectations with a solid organic growth when excluding our Consumer Health business. Revenue growth in the Consumer Health business is expected to decline in the first half of fiscal '24 and then return to growth in the third quarter. This growth is driven in part by an impressive commercial win in the first quarter, a new strategic contract with one of the leading consumer health companies for our gummy pill offering.

轉向製藥和消費者健康。該部門第一季的業績符合我們的預期，在不包括我們的消費者健康業務的情況下實現了穩健的有機成長。消費者健康業務的收入成長預計將在 24 財年上半年下降，然後在第三季恢復成長。這一增長的部分原因是第一季令人印象深刻的商業勝利，即我們與一家領先的消費者健康公司就我們的軟糖產品簽訂了新的戰略合約。

This is in line with our strategy to leverage the Catalent brand to increase the penetration of the legacy Bettera business in the top global consumer health companies. Winning this contract, this important contract, while making progress on other exciting business development activities bolsters my confidence in our ability to achieve our goals for the PCH segment performance in fiscal '24 and beyond.

這符合我們利用 Catalent 品牌提高傳統 Bettera 業務在全球頂級消費者健康公司中的滲透率的策略。贏得這份重要的合同，同時在其他令人興奮的業務開發活動上取得進展，增強了我對我們在 24 財年及以後實現 PCH 部門業績目標的信心。

Before I hand the call to Matti, I would like to touch on some important and exciting updates about the Biologics business on the commercial front.

在打電話給 Matti 之前，我想談談生物製品業務在商業方面的一些重要且令人興奮的最新動態。

Our exposure to the GLP-1 opportunity is rapidly growing. We are now forecasting that a larger majority of our current and future pre-filled syringe capacity coming online in fiscal '24 through fiscal '26 is expected to be booked soon in support of this exciting category of products, confirming our position as a leading CDMO in this space globally. We have plans to accelerate our investments in this area within our existing sterile fill and finish facility in Bloomington and Anagni, including partnering with our customers.

我們對 GLP-1 機會的接觸正在迅速成長。我們現在預測，我們目前和未來在24 財年到26 財年上線的預充注射器產能中的大部分預計將很快被預訂，以支持這一令人興奮的產品類別，從而確認我們作為領先CDMO的地位在全球這個空間。我們計劃在布魯明頓和阿納尼現有的無菌填充和加工工廠內加快在這一領域的投資，包括與客戶合作。

We believe we are only beginning to see the tailwinds from this category. Just for reference, in fiscal '24, we expect revenues of less than $100 million from GLP-1 programs. Once all these lines I just referred to are completed and running at scale, we anticipate this product category to contribute well over $0.5 billion in revenue.

我們相信，我們才剛開始看到這一類別的優勢。僅供參考，在 24 財年，我們預計 GLP-1 項目的營收將低於 1 億美元。一旦我剛才提到的所有這些生產線都完成並大規模運行，我們預計該產品類別將貢獻遠遠超過 5 億美元的收入。

As you all know, GLP-1s present an enormous opportunity for growth in the coming years. The major role that Catalent will play in bringing this important innovation to market, especially so soon after our contributions during the COVID pandemic, is a testament to our unique capabilities and positioning. Catalent's Board and management team remain confident in the future of our company as we continue to make strides towards improving our operations and bringing our margin performance back to pre-COVID level with urgency while growing the exposure of the company in the most exciting areas of the biopharmaceutical service industry.

眾所周知，GLP-1 在未來幾年提供了巨大的成長機會。康泰倫特將在將這項重要創新推向市場方面發揮重要作用，特別是在我們在新冠疫情期間做出貢獻之後不久，這證明了我們獨特的能力和定位。 Catalent 的董事會和管理團隊對我們公司的未來仍然充滿信心，因為我們將繼續在改善營運方面取得重大進展，並緊急將我們的利潤表現恢復到新冠疫情爆發前的水平，同時增加公司在最令人興奮的領域的曝光度。生物醫學服務業。

We remain focused on delivering value for all our shareholders by executing on our mission to improve the lives of patients every day.

我們始終致力於透過履行改善患者日常生活的使命，為所有股東創造價值。

I will now turn it to Matti for a discussion of our Q1 financial results.

我現在將請馬蒂討論我們第一季的財務表現。

Thank you, Alessandro. I'd like to begin with an update regarding the status of both our annual report on Form 10-K for the fiscal year ended June 30, 2023; and quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2023. While we have implemented improvements in our accounting and finance staffing and related closing processes, as we noted in our notification of late filing on Form 12b-25 filed on Monday, we were unable to file our 10-K and 10-Q on time.

謝謝你，亞歷山德羅。首先，我想介紹一下截至 2023 年 6 月 30 日財政年度的 10-K 表格年度報告的最新情況；以及截至2023 年9 月30 日的財政季度的10-Q 表格季度報告。儘管我們已對會計和財務人員配置以及相關結帳流程進行了改進，但正如我們在12b-25 表格遲交通知中指出的那樣，週一，我們無法按時提交 10-K 和 10-Q。

We require additional time to complete procedures related to management's assessment of the effectiveness of our internal controls over financial reporting as of June 30, 2023, and other closing procedures. This has included procedures related to the management's assessment of the measurement and timing of a noncash goodwill impairment of approximately $700 million, which relates primarily to acquisitions in the company's Consumer Health and Biomodalities reporting units in its Pharma and Consumer Health and Biologics segments, respectively.

我們需要更多時間來完成與管理層評估截至 2023 年 6 月 30 日財務報告內部控制有效性相關的程序以及其他結算程序。其中包括與管理層對約7 億美元非現金商譽減損的計量和時間安排進行評估相關的程序，該減值主要與該公司製藥部門的消費者健康和生物模態報告單位的收購以及消費者健康和生物製品部門的收購有關。

Please note that for purposes of providing our preliminary first quarter fiscal '24 earnings, we have assumed that the noncash goodwill impairment will be included in our first quarter results. We are also incurring substantial time to review other closing procedures supporting our 10-K and 10-Q for both reporting periods. We expect to file the Form 10-K on or before November 27, and we expect to file Form 10-Q promptly following the filing of our 10-K.

請注意，為了提供我們 24 年第一季財報的初步收益，我們假設非現金商譽減損將包含在我們第一季的業績中。我們也花了大量時間來審查支持兩個報告期間 10-K 和 10-Q 的其他結算程序。我們預計在 11 月 27 日或之前提交 10-K 表格，並預計在提交 10-K 後立即提交 10-Q 表格。

Additionally, based on currently available information and subject to completion of our evaluation of the potential impairment charge, as well as the preparation of our financial statements and assessment of our internal controls, we do not expect any material change to the financial results to be included in Form 10-K compared to the financial information reported in the preliminary earnings release Catalent furnished to the SEC on Form 8-K filed on August 29, 2023.

此外，根據目前可獲得的信息，在完成對潛在減值費用的評估、編制財務報表和評估內部控制後，我們預計財務業績不會發生任何重大變化表格10-K 中的財務信息與Catalent 於2023年8 月29 日提交給SEC 的表格8-K 中的初步收益報告中報告的財務資訊進行了比較。

We appreciate your patience as we work through and complete our closing procedures.

感謝您在我們處理並完成結帳程序時的耐心等待。

Moving on to our preliminary first quarter results. Starting with the consolidated numbers on Slide 6. Net revenue in the quarter was $982 million, down 4% on a reported basis and 6% on a constant currency basis compared to the prior first quarter. This decline is primarily attributed to the significant reduction in COVID revenue of approximately $85 million in the quarter as well as a onetime $30 million licensing fee in the prior year. This was partially offset by constant currency revenue growth in the rest of Biologics of 11% and 5% in PCH. The Metrics acquisition, which is reported in the PCH segment and closed in October of 2022, accounted for 2% growth on a consolidated basis.

接下來是我們第一季的初步業績。從投影片 6 的綜合數據開始。本季淨收入為 9.82 億美元，與上一季相比，按報告數據計算下降 4%，以固定匯率計算下降 6%。這一下降主要歸因於本季 COVID 收入大幅減少約 8,500 萬美元，以及上一年一度的 3,000 萬美元許可費。這被其他生物製劑領域 11% 和 PCH 領域 5% 的持續貨幣收入成長所部分抵消。 Metrics 收購已在 PCH 部門報告，並於 2022 年 10 月完成，合併後成長了 2%。

Our first quarter adjusted EBITDA decreased 38% to $115 million or a margin of 11.7% versus margin of 18.3% in the prior year quarter. On an organic basis, our first quarter adjusted EBITDA declined 45% compared to the first quarter of the prior year, primarily driven by a decline in COVID revenue. I will speak further to the major drivers of these results in the segment commentary.

我們第一季調整後 EBITDA 下降 38%，至 1.15 億美元，利潤率為 11.7%，而去年同期利潤率為 18.3%。從有機角度來看，我們第一季調整後的 EBITDA 與去年第一季相比下降了 45%，這主要是由於新冠疫情收入下降所致。我將在分部評論中進一步討論這些結果的主要驅動因素。

Adjusted net loss was $19 million or a loss of $0.10 per diluted share compared to adjusted net income of $61 million or $0.34 per diluted share last year. Reconciliations from GAAP net earnings to each of adjusted EBITDA and adjusted net income are in the appendix into the slide deck. Excluded from adjusted net income are the noncash goodwill impairments totaling $700 million I just reviewed.

調整後淨虧損為 1,900 萬美元，或稀釋後每股虧損 0.10 美元，而去年調整後淨利為 6,100 萬美元，或稀釋後每股虧損 0.34 美元。幻燈片附錄中提供了 GAAP 淨利潤與調整後 EBITDA 和調整後淨利潤的調整表。調整後淨利潤中不包括我剛剛審查過的總計 7 億美元的非現金商譽減損。

Now I'll discuss our segment performance, where commentary around segment growth will be in constant currency. As shown on Slide 7, First quarter net revenue in our Biologics segment was $447 million, a 16% decrease compared to the prior year quarter. The decline is primarily driven by significantly lower year-on-year COVID demand. First quarter COVID revenue of approximately $100 million represents a decline of approximately $85 million from the prior year period.

現在我將討論我們的細分市場表現，其中有關細分市場成長的評論將以不變的貨幣表示。如投影片 7 所示，我們生物製劑部門第一季的淨收入為 4.47 億美元，比去年同期下降 16%。下降的主要原因是新冠疫情需求較去年同期大幅下降。第一季的新冠肺炎收入約為 1 億美元，較去年同期減少約 8,500 萬美元。

On a non-COVID basis, Biologics revenue in the first quarter was in line with the first quarter of 2023. When excluding the onetime $30 million licensing fee signed in the prior year, non-COVID year-on-year revenue growth in this segment is approximately 11%. This result was driven by double-digit revenue growth in gene therapy, non-COVID drug product and drug substance, offset by a decline in cell therapy.

在非新冠疫情的基礎上，生物製劑第一季的收入與 2023 年第一季持平。若排除上一年簽署的一次性 3000 萬美元許可費，該細分市場的非新冠疫情收入同比增長約為11%。這一結果是由基因治療、非新冠藥物產品和原料藥的兩位數收入增長所推動的，但被細胞治療的下降所抵消。

The bar chart on Slide 7 illustrates the Biologics commercial and development revenue streams, or -- the classification of development versus commercial is driven by the contractual language, which does not always align with the regulatory status of a given product. The large drop in development revenue in the first quarter had 2 primary drivers: First, the year-on-year decline in COVID revenue that has been designated as development revenue; and second, a large gene therapy product whose revenue was treated as development revenue a year ago is now treated as commercial revenue.

投影片 7 上的長條圖說明了生物製劑商業和開發收入流，或 - 開發與商業的分類是由合約語言驅動的，而合約語言並不總是與給定產品的監管狀態一致。第一季開發收入大幅下降有兩個主要驅動因素：一是被指定為開發收入的新冠疫情收入較去年同期下降；其次，大型基因治療產品的收入在一年前被視為開發收入，現在被視為商業收入。

Moving to EBITDA. The Biologics segment's first quarter EBITDA was down $61 million year-over-year to $52 million, but was up $64 million sequentially from a $12 million loss in the fourth quarter. The sequential improvement from the fourth quarter to the first quarter is primarily a result of improved productivity and schedule adherence in the BWI and Brussels facilities.

轉向 EBITDA。生物製劑部門第一季 EBITDA 年減 6,100 萬美元，至 5,200 萬美元，但較第四季虧損 1,200 萬美元環比成長 6,400 萬美元。從第四季度到第一季的連續改善主要是由於 BWI 和布魯塞爾工廠的生產力和進度遵守率的提高。

Margin was 11.6% compared to 21.5% recorded in the prior year and up 1,400 basis points sequentially. The year-on-year drop in EBITDA margin was primarily driven by COVID declines as well as underutilization at new modality facilities, including our cell therapy business.

利潤率為 11.6%，較去年同期的 21.5% 上升 1,400 個基點。 EBITDA 利潤率年減主要是由於新冠疫情導致的下降以及包括我們的細胞治療業務在內的新醫療設施使用率不足所致。

We reduced our cell therapy cost structure during the quarter and expect improved performance in the second half of fiscal 2024. Similarly, in Bloomington, we have formalized a transformation project that will help drive margin improvement this year and in the future. When combining these prudent actions and our projected increase in revenue growth, we expect our Biologics segment to improve margins on a year-over-year basis with a more pronounced impact as we exit the fiscal year.

我們在本季度降低了細胞治療成本結構，並預計2024 財年下半年的業績將有所改善。同樣，在布魯明頓，我們已經正式製定了一個轉型項目，該項目將有助於推動今年和未來的利潤率改善。將這些審慎行動與我們預期的收入成長成長相結合，我們預計生物製劑部門的利潤率將同比提高，並在本財年結束時產生更顯著的影響。

Our non-COVID non-Sarepta Biologics business is expected to grow in the low- to mid-teens in fiscal '24 as we launch GLP-1 production, and bring on incremental capacity and improve productivity. Importantly, we have high visibility over this growth given the strong demand from customers.

隨著我們啟動 GLP-1 生產，並增加產能並提高生產率，我們的非新冠非 Sarepta 生物製品業務預計將在 24 財年實現兩位數左右的成長。重要的是，鑑於客戶的強勁需求，我們對這種成長具有很高的知名度。

As a result of our unique scale and capabilities in sterile fill/finish, we continue to install and qualify new prefilled syringe lines in our global network and are excited to have more prefilled lines on order as part of our committed CapEx spend coming online in fiscal '25 and '26. We believe this investment will drive a highly attractive return on capital for Catalent over the long term as we install and validate those lines in our existing facilities.

由於我們在無菌填充/完成方面的獨特規模和能力，我們繼續在我們的全球網絡中安裝和鑑定新的預灌裝注射器生產線，並且很高興能夠訂購更多預灌裝生產線，作為我們在財政年度上線的承諾資本支出的一部分'25 和 '26。我們相信，從長遠來看，隨著我們在現有設施中安裝和驗證這些生產線，這項投資將為康泰倫特帶來極具吸引力的資本回報。

As shown on Slide 8, our Pharma and Consumer Health segment generated net revenue of $535 million, an increase of $23 million or 5% compared to the prior year first quarter, with segment EBITDA of $101 million, down $10 million or a 9% decline over the same period. The segment's revenue growth was primarily driven by the prior year's acquisition of Metrics.

如幻燈片8 所示，我們的製藥和消費者健康部門淨收入為5.35 億美元，與去年第一季相比增加了2,300 萬美元，即5%，該部門的EBITDA 為1.01 億美元，減少了1000 萬美元，即下降了9%同一時期。該部門的收入成長主要是由去年的收購 Metrics 所推動。

On an organic basis, the segment declined 1% as growth in prescription products and clinical supply services was outweighed by softness in Consumer Health. We expect Consumer Health to decline in the first half of fiscal '24 and return to year-on-year growth in the second half of the year, in part due to the recently signed substantial contract with their premier consumer health company.

從有機角度來看，該細分市場下降了 1%，因為處方產品和臨床供應服務的成長被消費者健康領域的疲軟所抵消。我們預計消費者健康業務將在 24 財年上半年下滑，並在下半年恢復同比增長，部分原因是最近與其主要的消費者健康公司簽署了實質合約。

Adjusted EBITDA margin of 18.9% was lower by 280 basis points year-over-year from the 21.7% recorded in the prior first quarter. The decline was primarily related to underabsorbed capacity in the gummy network and the impact of a onetime $10 million insurance benefit received in the first quarter of fiscal '23. PCH has strong underlying fundamentals and continues to perform at a high level.

調整後 EBITDA 利潤率為 18.9%，較上年同期的 21.7% 下降 280 個基點。這一下降主要與軟糖網路的容量吸收不足以及 23 財年第一季收到的一次性 1000 萬美元保險福利的影響有關。 PCH 擁有強大的基本面，並繼續保持高水準的表現。

Slide 9 discusses our debt, debt maturities, related ratios and CapEx plans. Our debt load remains well structured and allows for good flexibility. Our nearest maturity is not until 2027. Our primary debt covenant is the ratio of net first lien debt over the trailing 12-months adjusted EBITDA. The covenant requires this ratio to remain below 6.5x and the September 30 actual level was 3.4x.

第 9 張投影片討論了我們的債務、債務到期日、相關比率和資本支出計劃。我們的債務負擔結構良好，並具有良好的靈活性。我們最近的到期日要到 2027 年。我們的主要債務契約是淨第一留置權債務與過去 12 個月調整後 EBITDA 的比率。契約要求這一比率保持在 6.5 倍以下，而 9 月 30 日的實際水準為 3.4 倍。

Catalent's overall net leverage ratio as of September 30, 2023, was 7.4x, a sequential increase from the fourth quarter at 6.4x, driven by the lower year-on-year last-12-months adjusted EBITDA. Because the EBITDA portion of the net debt leverage ratio is calculated on an LTM basis, we expect this ratio to peak at the end of the second quarter due to the significant decline in COVID revenue on a year-over-year basis and then rapidly improve in the second half of the fiscal year back to the June 30, 2023, level as our adjusted EBITDA recovers to more normalized levels.

截至 2023 年 9 月 30 日，康泰倫特的整體淨槓桿率為 7.4 倍，較第四季的 6.4 倍環比增長，原因是過去 12 個月調整後 EBITDA 同比下降。由於淨債務槓桿率中的 EBITDA 部分是按 LTM 計算的，因此我們預計該比率將在第二季度末因新冠疫情收入同比大幅下降而達到峰值，然後迅速改善隨著我們調整後的EBITDA 恢復到更加正常化的水平，我們將在本財年下半年回到2023 年6 月30 日的水平。

One of our top priorities remains reducing our leverage. And as we disclosed last quarter, we are taking a number of steps to achieve this, including: Reducing working capital, ensuring that CapEx spend is aligned with our strategic initiatives with shorter payback periods and maximizing EBITDA with revenue growth and cost structure alignment initiatives. With these initiatives underway, including the recent finalization of a contract amendment with one of our large customers in gene therapy, we expect to significantly improve our cash flow generation as we substantially reduce the level of contract assets.

我們的首要任務之一仍然是減少槓桿。正如我們上季度所揭露的，我們正在採取一系列措施來實現這一目標，包括：減少營運資本，確保資本支出與我們的策略計畫保持一致，縮短投資回收期，並透過收入成長和成本結構調整計劃來最大化EBITDA。隨著這些措施的實施，包括最近與我們的基因治療大客戶之一完成合約修訂，我們預計隨著我們大幅降低合約資產水平，我們的現金流量將顯著改善。

We now expect free cash flow to be in excess of $100 million in fiscal '24 versus our initial expectation of neutral. We continue to identify opportunities to drive further free cash flow generation for the year.

我們現在預計 24 財年的自由現金流將超過 1 億美元，而我們最初的預期是中性的。我們將繼續尋找機會推動今年進一步產生自由現金流。

Our combined balance of cash and cash equivalents as of September 30, 2023, was $209 million, a decrease of $71 million from June 30, 2023. The decrease in cash was driven primarily by an increase in contract assets in the quarter related to the ramp-up of production to meet customer demand. As of September 30, 2023, contract assets had a balance of $543 million, a sequential increase of $107 million and up $82 million year-on-year. Importantly, we expect the contract asset balance to decrease going forward.

截至 2023 年 9 月 30 日，我們的現金和現金等價物合併餘額為 2.09 億美元，較 2023 年 6 月 30 日減少 7,100 萬美元。現金減少主要是由於本季度與增產相關的合約資產增加所致提高產量以滿足客戶需求。截至2023年9月30日，合約資產餘額為5.43億美元，季增1.07億美元，年增8,200萬美元。重要的是，我們預計未來合約資產餘額將減少。

At September 30, we had one strategic customer, a majority of whose business relates to our gene therapy platform, that represented 30% of our $1.4 billion in aggregate net trade receivables and contract assets. We continue to convert the contract assets to accounts receivable and receive timely payments from the customer. As such, we are very confident about the collectibility of our contract asset balance, the reduction of which will accelerate as a result of the previously mentioned contract amendment.

截至 9 月 30 日，我們有一位策略客戶，其大部分業務與我們的基因治療平台有關，占我們 14 億美元淨貿易應收帳款和合約資產總額的 30%。我們繼續將合約資產轉換為應收帳款，並及時收到客戶的付款。因此，我們對合約資產餘額的可收回性非常有信心，由於先前提到的合約修改，合約資產餘額的減少將會加速。

The same customer represented approximately 16% of consolidated revenue in the first quarter of fiscal '24 or approximately $155 million. We expect revenue contribution from this customer to also be approximately 16% of total consolidated revenue for the full fiscal year. We have clear line of sight into this outlook given already committed orders.

同一客戶約佔 2024 財年第一季綜合營收的 16%，約 1.55 億美元。我們預計該客戶的收入貢獻也將佔整個財年合併總收入的約 16%。鑑於已經承諾的訂單，我們對這一前景有清晰的認識。

Finally, CapEx in the first quarter was $84 million. We continue to expect CapEx in fiscal '24 to be in the range of 8% to 10% of revenue, representing approximately $400 million.

最後，第一季的資本支出為 8,400 萬美元。我們仍預期 24 財年的資本支出將佔營收的 8% 至 10%，相當於約 4 億美元。

Please now turn to our financial outlook for fiscal '24, as outlined on Slide 10. With 1/3 of the fiscal year behind us, we are confident in reiterating our fiscal '24 guidance, which includes net revenue in the range of $4.3 billion to $4.5 billion, representing growth of 3% at the midpoint. Adjusted EBITDA range from $680 million to $760 million and adjusted net income in the range of $113 million to $175 million.

現在請轉向我們對 24 財年的財務展望，如幻燈片 10 中所述。本財年已經過去 1/3，我們有信心重申我們的 24 財年指導，其中包括 43 億美元的淨收入至45億美元，中間值成長3%。調整後的 EBITDA 範圍為 6.8 億美元至 7.6 億美元，調整後的淨利潤範圍為 1.13 億美元至 1.75 億美元。

Our underlying assumptions are largely the same, with the exception that we now expect COVID revenue of approximately $180 million, $50 million more than our previous expectation of $130 million. Roughly offsetting the COVID revenue increase are unfavorable FX rates in the euro and British pound.

我們的基本假設基本上相同，但我們現在預計新冠疫情收入約為 1.8 億美元，比我們之前預期的 1.3 億美元多出 5,000 萬美元。歐元和英鎊不利的匯率大致抵消了新冠疫情帶來的收入成長。

As a reminder, our non-COVID business is expected to continue to deliver strong performance with full year revenue growth in the mid- to high-teens for the company. This is driven by roughly 30% growth in our non-COVID Biologics portfolio, including approximately 65% revenue growth from our largest customer, which at this point of the year, is largely contracted.

謹此提醒，我們的非新冠疫情業務預計將持續表現強勁，公司全年營收成長將達到中雙位數。這是由我們的非新冠生物製劑產品組合約 30% 的增長推動的，其中包括來自我們最大客戶的約 65% 的收入增長，而今年這個時候，該客戶的收入基本上已經收縮。

Non-COVID non-Sarepta Biologics segment growth is expected to be low- to mid-teens, driven by tech transfer activities. In PCH, we continue to expect mid- to high single-digit growth. As we ramp up our non-COVID business and align our cost structure, we expect margins for the company and the Biologics segment to recover towards historical annual EBITDA margins as we exit fiscal '24.

在技​​術轉移活動的推動下，非新冠疫情非 Sarepta Biologics 細分市場的成長預計將在十幾歲至中十幾歲之間。在PCH，我們繼續預期中高個位數成長。隨著我們擴大非新冠業務並調整成本結構，我們預計公司和生物製劑部門的利潤率將在我們退出 24 財年時恢復到歷史年度 EBITDA 利潤率。

We forecast roughly 2/3 of consolidated adjusted EBITDA to be generated in the second half of the year. As shared on our last call, the overall expected revenue split is more balanced with approximately 55% expected in the second half of 2024.

我們預計約 2/3 的綜合調整後 EBITDA 將在今年下半年產生。正如我們在上次電話會議中分享的那樣，整體預期收入分配更加平衡，預計 2024 年下半年約為 55%。

In closing, our priorities for fiscal '24 remain intact: To improve our margins by supporting productivity and cost alignment plans; to deliver incremental free cash flow by lowering the company's working capital intensity and maximizing commercial opportunities; and finally, to strengthen our internal controls and processes over financial reporting and forecasting. With thorough, careful analysis and disciplined execution of our cost structure, we are making steady progress against these initiatives and are optimistic in our continuously improving performance throughout fiscal year 2024.

最後，我們 24 財年的優先事項保持不變：透過支持生產力和成本調整計畫來提高我們的利潤率；透過降低公司的營運資本強度和最大化商業機會來提供增量自由現金流；最後，加強我們對財務報告和預測的內部控制和流程。透過對我們的成本結構進行徹底、仔細的分析和嚴格的執行，我們正在這些舉措上穩步取得進展，並對我們在 2024 財年不斷提高業績持樂觀態度。

Operator, this concludes our prepared remarks. 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) Our first question today comes from Tejas Savant of Morgan Stanley.

（操作員指令）我們今天的第一個問題來自摩根士丹利的 Tejas Savant。

Alessandro, one on Sarepta for you to kick things off. You've talked in the past of not peaking in the label expansion for ELEVIDYS into your forecast. Sarepta, I think, as you alluded to, said they want to manufacture in anticipation of the unrestricted label ahead of that FDA decision.

Alessandro，Sarepta 上的一位，為您拉開序幕。您過去曾說過，您的預測中沒有將 ELEVIDYS 的廠牌擴張達到頂峰。我認為，正如您所提到的，Sarepta 表示，他們希望在 FDA 做出決定之前預計將獲得不受限制的標籤。

So how should we think about the implications of that in terms of perhaps potential upside for you in your FY '24 guide? Does the $700 million-or-so that you're baking in for Sarepta, the midpoint, factor this in, in light of your comments that I think you said you're starting to get orders from Sarepta now for that incremental production.

那麼，我們應該如何考慮這對您在 24 財年指南中可能帶來的潛在好處的影響？根據您的評論，您為 Sarepta 準備的 7 億美元左右（中點）是否將這一點考慮在內，我認為您說過您現在開始從 Sarepta 獲得增量生產的訂單。

And then in terms of the potential downside to fiscal '25 if the FDA doesn't allow for label expansion. Any sort of framework that you can help us think through that dynamic here?

然後，如果 FDA 不允許標籤擴展，那麼 25 財年的潛在負面影響。有什麼框架可以幫助我們思考這裡的動態嗎？

Sure. Hi, everyone. Look, this is a good question. I would tell you, overall, the way I'll characterize the relationship with Sarepta, there is a lot of positive momentum into the relationship.

當然。大家好。瞧，這是個好問題。我想告訴你，總的來說，我對與 Sarepta 關係的描述方式是，這段關係有很多正面的動力。

When you think about, number one, our performance. Really -- our Q1 performance was really underpinned by a strong operational performance at our BWI facility, where we support Sarepta. And even the recent months have been even more reassuring that we are on the right path from an operational performance standpoint.

當你想到第一，我們的表現。確實，我們第一季的業績確實得益於我們為 Sarepta 提供支援的 BWI 工廠的強勁營運業績。甚至最近幾個月也更令人放心，從營運績效的角度來看，我們正走在正確的道路上。

The contract amendment that Matti mentioned, which will really allow us now to normalize more the time to cash profile of this important contracts, which in turn, will reduce contract assets, improve cash flow, really also the firm demand that we've seen in the recent weeks.

馬蒂提到的合約修正案，這實際上將使我們現在能夠使這份重要合約的兌現時間更加正常化，這反過來又會減少合約資產，改善現金流，這實際上也是我們在最近幾週。

So going to your question, really, look, our job is to continue to leverage the capacity that we have deployed, the suites with which we are supporting the customer, continue to now sustain this very good level of performance, which is the one that will allow us to satisfy this demand.

因此，針對您的問題，實際上，我們的工作是繼續利用我們已部署的容量，以及我們為客戶提供支援的套件，繼續維持這種非常好的性能水平，這就是將使我們能夠滿足這一需求。

And in terms of your -- last part of your question in terms of you -- I will not speculate, of course, on the label expansion of FDA, it's not my place to do so. But in terms of making your model and working through your model, I will remind that, as we disclosed, indeed 50% of the revenues are pass-through revenues coming at fairly low margin with a mid- to high single-digit margin. But these are materials and testing services we buy on behalf of the customer. So this could -- I believe it can be helpful in modeling this out.

至於你的問題的最後一部分，我當然不會猜測 FDA 的標籤擴展，這不是我的職責。但在製作模型和研究模型方面，我要提醒大家的是，正如我們所揭露的，實際上 50% 的收入是轉嫁收入，其利潤率相當低，但利潤率為中高個位數。但這些是我們代表客戶購買的材料和測試服務。所以這可能——我相信這有助於對此進行建模。

Got it. That's actually helpful. And then I want to ask one on just ex COVID, ex Sarepta growth on a sequential basis. Just doing some quick math here. It sounds like you guys had about $235 million in Biologics revenue last quarter. That went to about maybe $185-ish million this quarter.

知道了。這實際上很有幫助。然後我想問一下關於前新冠疫情和前薩雷普塔的連續增長情況。只是在這裡做一些快速的數學計算。聽起來你們上個季度的生物製品收入約為 2.35 億美元。本季這一數字可能達到 1.85 億美元左右。

And so can you just walk us through the moving pieces there? I know you gave color year-over-year, but just sequentially. And I know you got the fill/finish capacity utilization for COVID here. Did that play a role in this, or was it sort of some of the cell therapy work declining?

那麼您能向我們介紹一下那裡的活動嗎？我知道你逐年提供顏色，但只是按順序提供。我知道您在這裡了解了新冠疫情的填充/完成產能利用率。這是否在其中發揮了作用，或者是某些細胞治療工作的衰退？

And then on your comment on the significant GLP-1 ramp over the next couple of fiscal years for you here. Any color on the slope of that increase and at the cadence at which you expect this new capacity to come online?

然後是您對未來幾個財年 GLP-1 大幅增長的評論。您預期這種新容量上線的斜率和節奏有什麼顏色嗎？

Yes, sure. Look, I'm going to cover the GLP-1 and then hand over to Matti to give you some [info regarding] Q1. But when it comes to GLP-1, I would say, for this fiscal year, it's fundamentally a second half story, right? The second half is really when the commercial production is going to start coming on the -- on some of the new assets.

是的，當然。看，我將介紹 GLP-1，然後交給 Matti 為您提供一些[有關] Q1 的資訊。但說到 GLP-1，我想說，對於本財年來說，這基本上是後半段故事，對嗎？下半年確實是一些新資產開始商業化生產的時候。

I would also add that, as I said, we expect significant new capacity coming online between fiscal '24 and fiscal '26. And probably the way you should be thinking about this is probably that, each of these given years, we're going to more than double the capacity that is going to be deployed against the GLP-1. So any given year.

我還要補充一點，正如我所說，我們預計在 24 財年和 26 財年之間將有大量新產能上線。也許您應該考慮的方式是，在這些年中的每一年，我們都會將針對 GLP-1 部署的容量增加一倍以上。所以任何給定的年份。

So there are a lot of lines that are already installed and they have been qualified. So some of them will come to the end of this fiscal year, full strength next year. There is the phasing. Then next year is really going to be a full year story, not only H2. And so I believe that, assuming that there will be more than doubling the capacity available for this demand, and the fact that we have a very strong visibility to the demand, can be helpful for you to understand the ramp.

所以有很多線路已經安裝完畢並且已經合格。因此，他們中的一些人將在本財年結束時，在明年全面恢復實力。有階段性。那麼明年真的將是一個全年的故事，而不僅僅是下半年。因此，我相信，假設該需求的可用容量將增加一倍以上，並且我們對需求有非常強的可見性，這可能有助於您了解坡道。

Yes. So I think so Biologics non-COVID revenue and then stripping out the $30 million licensing fee from the prior year quarter, we're up 11%. So I think I put that in the script. And I think I talked about that but maybe you didn't pick it up. But we can reconcile the quarterly...

是的。因此，我認為，生物製劑非新冠疫情收入，然後剔除去年同期 3,000 萬美元的授權費，我們成長了 11%。所以我想我把它寫進劇本裡了。我想我談過這一點，但也許你沒有註意到。但我們可以調整季度...

No, I was just talking about the sequential trends there, Matti. What happened in 4Q versus 1Q, not year-over-year.

不，我只是在談論那裡的連續趨勢，馬蒂。第四季與第一季發生的情況，而不是同比情況。

So fourth quarter. So clearly, our BWI business has really kind of come -- has bounced back and then Brussels continued to improve. And so those were the 2 primary businesses, with BWI being the gene therapy business, with our ramp-up as I discussed in the script, it -- obviously, our BWI gene therapy business is well up.

那麼第四季。很明顯，我們的 BWI 業務確實已經反彈，然後布魯塞爾繼續改善。這些就是兩個主要業務，BWI 是基因治療業務，正如我在腳本中討論的那樣，我們的成長，很明顯，我們的 BWI 基因治療業務正在蓬勃發展。

Our next question today comes from Luke Sergott of Barclays.

今天我們的下一個問題來自巴克萊銀行的盧克·塞爾戈特。

Great. I just kind of want to dig in here on the overall gene therapy franchise and how big this is for you. I know that you have you guys have always bucketed it as your mAbs and the other drivers of indications. And it would kind of be helpful as you think about the rest of the gene therapy business outside of the Sarepta 9001 or ELEVIDYS drug.

偉大的。我只是想深入了解整個基因治療系列以及這對您來說有多大。我知道你們一直把它當作你們的單株抗體和其他適應症的驅動因素。當您考慮 Sarepta 9001 或 ELEVIDYS 藥物以外的其他基因療法業務時，這會有所幫助。

Luke, thanks. This is Alessandro. Luke, first of all, let me clarify. Our mAbs protein business is not classified under gene therapy, we call it drug substance. And thanks for the question because we are really having a very good year in drug substance. And I do believe there is good momentum going forward there.

盧克，謝謝。這是亞歷山德羅。盧克，首先讓我澄清一下。我們的單株抗體蛋白業務不屬於基因治療，我們稱之為原料藥。感謝你提出這個問題，因為我們在原料藥方面確實度過了非常美好的一年。我確實相信那裡有良好的發展勢頭。

We had a lot of seeding happening in that business over the last several years, and now it seems that the harvest time is coming with a significant amount of late-stage program heading toward commercialization. Some of them, very exciting, have been acquired by big pharma, so they have extended patient populations. So very exciting areas for us, drug substance, and I believe will be a great contributor as we go forward.

在過去的幾年裡，我們在該業務中進行了大量的播種工作，現在看來，隨著大量後期項目走向商業化，收穫的時刻即將到來。其中一些非常令人興奮，已被大型製藥公司收購，因此擴大了患者群體。對於我們來說非常令人興奮的領域，原料藥，我相信將在我們前進的過程中做出巨大的貢獻。

In terms of the gene therapy business, as I said, that we have a pretty balanced portfolio. Number one, with Sarepta as well, we have several programs with them, some of them very exciting. But also, there is -- I've seen some good momentum there. Some programs getting some early, very good clinical data which made the customers more bullish in moving full steam ahead in scaling up.

就基因治療業務而言，正如我所說，我們擁有相當平衡的投資組合。第一，我們與 Sarepta 合作，有多個項目，其中一些非常令人興奮。而且，我也看到了一些好的動力。一些計畫獲得了一些早期的、非常好的臨床數據，這使得客戶更加樂觀地全力推動擴大規模。

So Luke, the private funding environment, it is what it is. We were the first one to call it out 1 year ago, still remains a little bit uncertain. But when you look at our own portfolio and our own pipeline, I feel pretty good about it. The cell therapy story remains a little bit one where we have reviewed our outlook there. We have reassessed our outlook. And so as Matti said, we take an opportunity to want to really rebalance the absorption there. And this will be a driver of margin improvement going forward because now we're going to suffer by much less underutilization and negative EBITDA impact there.

所以盧克，私人融資環境，就是這樣。一年前我們是第一個提出這一點的，但仍然有點不確定。但當你看看我們自己的投資組合和管道時，我感覺非常好。細胞療法的故事仍然有點單一，我們已經回顧了我們的前景。我們重新評估了我們的前景。正如馬蒂所說，我們藉此機會想要真正重新平衡那裡的吸收。這將成為未來利潤率改善的推動力，因為現在我們將遭受更少的利用率不足和 EBITDA 負面影響。

So hopefully, this gives you a little bit of color across all the different subsegments.

希望這能為您在所有不同的細分市場中提供一點色彩。

Yes, that helps. And then I guess on the Biologics, there's elevated pass-through coming through here. You have the GLP-1, you have the pens also with the Sarepta, you guys kind of called that out. Can you update like how much of the business comes from the sourcing? And then are you seeing a similar margin that you have in the past there? Or is this going to be elevated like we saw with the COVID sourcing?

是的，這有幫助。然後我猜想在生物製劑中，這裡的傳遞率會增加。你們有 GLP-1，你們也有有 Sarepta 的筆，你們有點喊出來了。您能否更新一下有多少業務來自採購？那麼您是否看到了與過去類似的利潤率？或者這個數字會像我們在新冠疫情採購中看到的那樣上升嗎？

When you think of the Biologics business and the pass-through revenue, Sarepta has about a 50% pass-through content, and that's materials and testing. The balance of the business is between, I would say, 15% to 20% is where it sits from a pass-through perspective.

當你想到生物製品業務和轉嫁收入時，Sarepta 大約有 50% 的轉嫁內容，那就是材料和測試。我想說，從傳遞的角度來看，業務平衡在 15% 到 20% 之間。

And the margins are a little bit different. Margins are pretty low, as we articulated on the -- as Alessandro articulated on the Sarepta piece. And they're probably, I would say, mid-single digits to mid-teen digits on the margins on the balance of the business, of that 15% to 20%.

而且邊距有點不同。正如我們在 - 正如 Alessandro 在 Sarepta 作品中所闡述的那樣，利潤率相當低。我想說，在業務餘額中，它們的利潤率可能是個位數到十幾位數，即 15% 到 20%。

And I just would add one other element of color there, drug product is very different from drug substance in general when it comes to material pass-through. Not necessarily the materials are less expensive, but most of the times, they are bought by the customers, not by us. So they don't affect revenues, they don't affect our margin.

我只是想在那裡添加另一種顏色元素，就材料傳遞而言，藥品與一般原料藥非常不同。不一定是材料便宜，但大多時候是客戶買的，而不是我們買的。所以它們不會影響收入，也不會影響我們的利潤。

Our next question today comes from Dave Windley of Jefferies.

今天我們的下一個問題來自 Jefferies 的 Dave Windley。

I hope you can hear me. I'm in a hotel basement. Can you hear me?

我希望你能聽到我的聲音。我在一家旅館的地下室。你聽得到我嗎？

You sound good, Dave.

你聽起來不錯，戴夫。

Okay. All right. So my question is maybe a follow-on to Tejas' earlier question, but a broader one. The company, let's call it pre-pandemic, used to talk about the diversity of the platform, 7,000 products, no one product really makes up a substantial percentage of revenue, doesn't move the needle necessarily. And you're moving into a period where now 2 products very substantially move the needle.

好的。好的。所以我的問題可能是 Tejas 之前問題的後續問題，但範圍更廣。該公司，讓我們稱之為大流行前，曾經談論平台的多樣性，7,000 種產品，沒有一種產品真正佔收入的很大比例，不一定會有所改變。您正進入這樣一個時期，現在有兩種產品可以帶來顯著的改變。

I guess what I'm also thinking is that, again, related to Tejas' question, Sarepta has a label expansion kind of optionality element to it and the GLP-1s have oral delivery of GLP-1 data readouts coming out. So how do you think about the concentration of those revenue streams in your business and risk-mitigating that in the potential that both of them could see headwinds from developments in the pipeline?

我想我也在想的是，再次與 Tejas 的問題相關，Sarepta 有一個標籤擴展類型的可選元素，並且 GLP-1 口頭提供了 GLP-1 數據讀數。那麼，您如何看待這些收入流在您的業務中的集中度以及降低風險的可能性，因為它們都可能會因管道的發展而遇到阻力？

Yes, sure. So Dave, a couple of things. First of all, you're calling out two of the key, I would say, dynamic of our industry overall, surely GLP-1 being one. And I feel very proud and look excited that Catalent was able to have such an exposure to that. So I don't see that necessarily under negative terms. It's great and it's something that can be applied across several therapeutic dynamics -- therapeutic areas, has dynamics across different geographies.

是的，當然。戴夫，有幾件事。首先，我想說，您提出了我們整個產業的兩個關鍵動態，GLP-1 肯定是其中之一。對於康泰倫特能夠如此接觸到這一點，我感到非常自豪和興奮。所以我並不認為這一定是負面的。它很棒，可以應用於多個治療動態——治療領域，在不同地區都有動態。

So I would say it's a little bit of a different element compared to the gene therapy program that you have mentioned. With regards of -- so -- and so it's such that you're also going forward, because of the different therapeutic areas, the different potential indication, extension of indications of GLP-1s, I don't see that category to be a significant element of volatility, so to speak.

所以我想說，與你提到的基因治療計劃相比，這有點不同。關於——所以——所以你也在前進，因為不同的治療領域、不同的潛在適應症、GLP-1適應症的擴展，我不認為該類別是一個可以說，波動性是一個重要因素。

Our job there, I believe, is to continue to do a great job for our customer and continue to bring the capacity online, and the rest will come pretty much as a consequence. I don't believe personally that oral will be a significant competitor of injection for the time being. I -- when you think about that, in the current form, like peptides, the bioavailability is not that high so there is a lot of API there. There are studies out there that are showing a much more API you need in the oral delivery versus injectables. So I do believe that it's going to be, for the time being, an injectable story personally.

我相信，我們的工作是繼續為我們的客戶做好出色的工作，並繼續使容量上線，其餘的工作將隨之而來。我個人認為口服藥物暫時不會成為注射藥物的重要競爭對手。我——當你想到這一點時，在目前的形式中，例如勝肽，生物利用度不是那麼高，所以那裡有很多 API。有研究表明，與注射劑相比，口服給藥所需的 API 數量要多得多。所以我確實相信，目前這將是一個可注入的個人故事。

And with regards of how we are approaching this, look, for me, the important thing is that we understand the dynamics, we understand the market, that we position ourselves a little bit in the middle of the range. We don't expect in our projections everything to be going in the right direction, and leaving that as an upside. We position ourselves in a, I would say, prudent way when it comes to these dynamics so that we have a good set of different options to continue to grow the company in line with expectations.

至於我們如何解決這個問題，對我來說，重要的是我們了解動態，我們了解市場，我們將自己定位在這個範圍的中間。在我們的預測中，我們並不期望一切都會朝著正確的方向發展，並將其視為有利的一面。我想說，在這些動態方面，我們以謹慎的方式定位自己，以便我們有一系列不同的選擇來繼續按照預期發展公司。

Our next question comes from Justin Bowers of Deutsche Bank.

我們的下一個問題來自德意志銀行的賈斯汀·鮑爾斯。

So just wanted to get a little clarity on some of the prepared remarks. With respect to GLP-1s, I think you said $100 million this year. Is that incremental over next -- sorry, over last year? Or is that total? And can you sort of give us a sense of what the order of magnitude was in FY 2023?

所以只是想澄清一些準備好的言論。關於 GLP-1，我想你說今年 1 億美元。明年的增量是──抱歉，是去年的增量嗎？或者說這是全部？您能否讓我們了解 2023 財年的數量級？

And then I think you said sort of a $500 million run rate number. And is that sort of like the targeted exit rate in FY 2026? Or is that sort of the contribution from the incremental capacity coming online? And then I think you said most of that, you have firm orders for. So do you have protection for that, i.e., some sort of take-or-pay arrangement?

然後我想你說的是 5 億美元的運行率數字。這有點像 2026 財年的目標退出率嗎？還是這是來自上線增量容量的貢獻？然後我想你說了大部分，你有確定的訂單。那麼你們對此有保護嗎，即某種照付不議的安排？

Great questions. So first of all, yes, look, we said that this year, it's going to be below $100 million. We didn't say $100 million. And this, for sure, one of the contributors of the non-COVID, non-Sarepta growth in Biologics, right? So because so far, there's been a more tech transfer work and now it's becoming commercial work. So first of all, it is contributing to our growth outlook. And as I said, it's more an H2 story than an H1 story. So it's also helping with what you see as a ramp, H2 versus H1.

很好的問題。首先，是的，我們說過今年的金額將低於 1 億美元。我們沒有說一億美元。這肯定是生物製品非新冠、非 Sarepta 成長的貢獻者之一，對嗎？因為到目前為止，已經有更多的技術轉移工作，現在它正在變成商業工作。首先，它有助於我們的成長前景。正如我所說，這更像是一個 H2 故事，而不是 H1 故事。所以它也有助於你所看到的斜坡，H2 與 H1。

With regards of the long-term outlook, I said that it's going to be well over $0.5 billion. I gave a little bit of color around the timeframe. And to be quite honest, with your question around the demand, I see for this franchise, the capacity as the constraining factor rather than the demand.

至於長期前景，我說過它將遠遠超過 5 億美元。我在時間範圍內給了一些顏色。說實話，對於你關於需求的問題，我認為對於這個特許經營權來說，能力是限制因素，而不是需求。

So it's going to be really depending on our ability to bring capacity as fast as possible. We are seeing a very high level of interest and demand for these assets, and really is one where capacity is going to be the constraining factor on all the fronts. And I believe that the runway goes beyond the '26 timeframe that we have highlighted here. So all in all, it's a very exciting space to be in.

因此，這實際上取決於我們盡快增加產能的能力。我們看到對這些資產的興趣和需求非常高，而且產能確實將成為所有方面的限制因素。我相信跑道超越了我們在這裡強調的 26 年時間範圍。總而言之，這是一個非常令人興奮的空間。

And then just a quick follow-up on the gene therapy franchise. Can you talk a little bit about the dynamics ex Sarepta? i.e., are there other programs in your pipeline that are advancing through different stages? And then with respect to the top customer, are you ramping up additional production throughout the year? Or is this just sort of a conversion of things in flight with the existing outlook?

然後是基因治療專營權的快速跟進。可以談談 Sarepta 之前的動態嗎？即，您的管道中是否還有其他正在經歷不同階段的項目？然後，對於頂級客戶，您是否全年都會增加產量？或者這只是某種事物與現有前景的轉換？

Yes. Look, first part of the question, as I said in my prepared remarks that the pipeline is healthy both with the additional program with our biggest customer but also with other customers. As I said, we signed recently another late-stage program, and the clinical data on that program looks very, very exciting. So -- and impact on patients is -- it could be great. So it's also in line with our core value of patients first.

是的。看，問題的第一部分，正如我在準備好的演講中所說，無論是與我們最大客戶還是與其他客戶的附加計劃，管道都是健康的。正如我所說，我們最近簽署了另一個後期項目，該項目的臨床數據看起來非常非常令人興奮。所以——對患者的影響是——它可能是巨大的。所以這也符合我們病人至上的核心價值。

So I would define the pipeline in gene therapy as healthy. And I will also tell you that, in gene therapy, the capacity, it's easier to redeploy compared to other technologies. Normally, in gene therapy, you have suites, but you have most of the units are mobile units. So it's very easy to reconfigure the capacity compared to other technologies, at least for the way we have designed our facility. We make them very, very fungible across different type of products.

所以我將基因治療的管道定義為健康的。我還要告訴你，在基因治療中，與其他技術相比，能力更容易重新部署。通常，在基因療法中，你有套房，但大多數單位都是移動單位。因此，與其他技術相比，重新配置容量非常容易，至少對我們設計設施的方式來說是如此。我們使它們在不同類型的產品中非常非常可互換。

And with regards to the profile of this. Look, we -- there is the physical capacity and there is the productivity that you can achieve. We are ramping, right? So our physical capacity is fully deployed, fully staffed, fully equipped. But clearly, we are a ramp of productivity. As you know, we come from a very difficult spot during the spring because of some of the challenges we have disclosed, and now we have an exciting ramp.

關於這個的簡介。聽著，我們——有你可以實現的體力能力和生產力。我們正在加速，對嗎？所以我們的物質能力已經充分部署、人員齊全、裝備齊全。但顯然，我們正在提高生產力。如您所知，由於我們披露了一些挑戰，我們在春季經歷了一個非常困難的境地，現在我們有了一個令人興奮的斜坡。

So I will tell you that we are ahead of the ramp that I had in mind at the beginning of this fiscal year, but there will continue to be progress as we go through the year. So the more we improve our output, the more demand we will be able to satisfy for our customers. As we said, the visibility on this demand is pretty high at this point of the year, as Matti shared.

因此，我要告訴大家，我們已經領先我在本財年年初設想的成長速度，但隨著這一年的進展，我們將繼續取得進展。因此，我們的產量提高得越多，我們就能滿足客戶更多的需求。正如我們所說，正如馬蒂所分享的那樣，今年這個時候這種需求的可見度相當高。

The next question in the queue today comes from Jack Meehan of Nephron Research.

今天隊列中的下一個問題來自 Nephron Research 的 Jack Meehan。

First, I was wondering if you could just elaborate on the factors that are leading the strategic review to take a bit longer? At least versus what I was expecting. Last quarter, the word urgent was used multiple times, and I was expecting some sort of update here. Can you just maybe talk about anything you can share?

首先，我想知道您能否詳細說明一下導致戰略審查時間較長的因素？至少與我的預期相反。上個季度，「緊急」這個詞被多次使用，我期待這裡有某種更新。您能談談您可以分享的任何事情嗎？

Yes, Jack, this is John. So if you think about the committee that we formed a couple of months ago, and we've got 2 new Directors and 2 of our legacy Directors plus myself on it. And I'd say the 3 top priorities of the activities of the committee have been to focus on operational improvements, along with Alessandro and the team, focus on cash flow improvements and focus on capital structure improvements over time. As you saw and heard in the comments, Alessandro and the team continue to drive operational performance and cash flow improvements in a way that gives us a lot of confidence for the rest of this year.

是的，傑克，這是約翰。因此，如果您考慮我們幾個月前成立的委員會，我們有 2 位新董事和 2 位舊董事加上我自己。我想說，委員會活動的三個首要任務是與亞歷山德羅和團隊一起專注於營運改進、關注現金流改善以及隨著時間的推移關注資本結構改善。正如您在評論中看到和聽到的那樣，亞歷山德羅和團隊繼續推動營運績效和現金流改善，這讓我們對今年剩餘時間充滿信心。

So I think the first 2 priorities were to get the company back on track out of the surprise mode which we've been in for the last several quarters and deliver on the commitments that the team's laid out. I think they've done a heck of a job doing that as we start fiscal '24.

因此，我認為前兩個優先事項是讓公司擺脫過去幾季的意外模式，回到正軌，並兌現團隊制定的承諾。我認為，在 24 財年開始之際，他們在這方面做得非常好。

The committee, along with our partners at Elliott, are evaluating several strategic options to address the capital structure improvements over time with the sense of urgency. We spent a heck of a lot of time getting everybody up to speed on where we are. It's an area where we don't want a ready, fire, aim. And with the operational improvements and the cash flow improvements, we're out of what may have been perceived by some as crisis mode and in a position where we can thoughtfully evaluate those options going forward.

該委員會與我們在 Elliott 的合作夥伴一起，正在評估幾種策略選擇，以隨著時間的推移解決資本結構的改進問題，並具有緊迫感。我們花了很多時間讓每個人都了解我們的情況。這是一個我們不希望有準備、開火、瞄準的區域。隨著營運的改進和現金流的改善，我們已經擺脫了一些人認為的危機模式，並且可以深思熟慮地評估未來的這些選擇。

In addition to the committee and the full Board, Alessandro and I spend a lot of time with our partners at Elliott evaluating those options. And we don't have anything to announce today. But as noted, we'll provide updates if and once specific decisions are made by the Board.

除了委員會和全體董事會之外，亞歷山德羅和我還花了很多時間與 Elliott 的合作夥伴一起評估這些選項。今天我們沒有什麼要宣布的。但如前所述，如果董事會做出具體決定，我們將提供最新資訊。

So I think that the near-term operational improvements, cash flow improvements you heard from Matti. We've improved our free cash flow outlook for the full year and then made some great moves along those lines as well. As well as the operational improvements you heard from Alessandro, those are on track. Capital structure over time, we'll address it. But we're not ready to announce any decisions today, but we'll do so once the Board and Alessandro and team make those decisions.

所以我認為你從馬蒂那裡聽到的近期營運改善、現金流改善。我們改善了全年的自由現金流前景，然後也沿著這些方向採取了一些重大措施。除了您從 Alessandro 那裡聽到的營運改進之外，這些都已步入正​​軌。隨著時間的推移，我們將解決資本結構問題。但我們今天還沒有準備好宣布任何決定，但一旦董事會、亞歷山德羅和團隊做出這些決定，我們就會宣布。

Okay. I appreciate that feedback. And a question for Matti. On the GLP-1s, can you talk about the returns you're expecting on this additional prefilled syringe fill/finish capacity you're adding? I'm having investors e-mail me for a little bit more detail on that. I know you said it would be attractive, but just any context would be great.

好的。我很欣賞這樣的回饋。還有一個問題要問馬蒂。關於 GLP-1，您能否談談您對添加的額外預充注射器填充/完成容量的預期回報？我讓投資者給我發電子郵件以了解更多細節。我知道你說過這會很有吸引力，但任何背景都很棒。

I really can't. I mean, I think Alessandro laid it out, we're in the stage of trying to book that business. And so I think it wouldn't be a good idea for me to disclose the returns and what we're looking at from a pricing perspective. So -- but I can tell you that it will be very attractive for Catalent overall.

我實在做不到。我的意思是，我認為亞歷山德羅已經說明了這一點，我們正處於嘗試預訂該業務的階段。因此，我認為揭露回報以及我們從定價角度看待的內容對我來說不是一個好主意。所以，但我可以告訴你，總體而言，這對康泰倫特來說非常有吸引力。

I would look to say that we have configured this franchise with lines which are twin of each other. So our ability to continue to deploy the product across multiple lines is on an accelerated fashion because we're just going to somewhat copy and paste what we have learned in the first track transfers. So you can expect that the ramp to revenues on the new assets are coming online is going to be faster. And that's the #1 factor that affects your return and the margin. But as Matti said, we expect the margin to be attractive.

我想說的是，我們已經用彼此孿生的線路配置了這個特許經營權。因此，我們繼續跨多條生產線部署產品的能力正在加速，因為我們只是要稍微複製和貼上我們在第一條軌道轉移中學到的東西。因此，您可以預期，新上線資產的收入成長將會更快。這是影響您的回報和利潤的第一大因素。但正如馬蒂所說，我們預計利潤率將具有吸引力。

Something thing I'd say is, from a ramp-up perspective, I think the company has proven itself. You look at what it did with COVID and the ramp-up of COVID and meeting the COVID demand. The company has a proven track record to ramp up quickly and ramp up its facilities quickly to deliver. And I think leveraging that experience of the company into the GLP-1 opportunity is significant.

我想說的是，從成長的角度來看，我認為該公司已經證明了自己。你看看它對新冠病毒做了什麼，以及新冠病毒的增加和滿足新冠病毒的需求。該公司擁有快速擴張和快速提升設施交付能力的良好記錄。我認為將公司的經驗運用到 GLP-1 機會中意義重大。

The next question comes from John Sourbeer of UBS.

下一個問題來自瑞銀集團的約翰·索爾比爾。

Two questions here. First one on COVID. Just any way to quantify what the COVID margin contribution was in the quarter? And COVID came in quite a bit ahead of our expectations. You raised the guidance there. Any color on just the pacing there for the remainder of the year?

這裡有兩個問題。第一個關於新冠病毒的。有什麼方法可以量化本季新冠疫情的利潤貢獻嗎？新冠疫情的到來遠遠超出了我們的預期。您在那裡提出了指導意見。今年剩下的時間裡，有進展嗎？

Yes, COVID will have a somewhat negligible impact in the back half of the year. So I think it's going to come down. The first half of the year is when we'll experience most of the COVID demand. There is some demand in the back half of the year.

是的，新冠疫情對下半年的影響可以忽略不計。所以我認為它會下降。今年上半年我們將經歷大部分新冠疫情需求。下半年有一定的需求。

And as for margins, that's not something that we've disclosed historically, and so we wouldn't want to disclose the margins on the COVID business. But -- so I'd say that -- that's about as far as I can go from a COVID perspective. But COVID is becoming a less and less important part of the business for us.

至於利潤率，這不是我們歷史上揭露過的內容，因此我們不想揭露新冠業務的利潤率。但是——所以我想說——從新冠肺炎的角度來看，這就是我所能做的了。但對我們來說，新冠疫情在業務上的重要性越來越低。

Yes. I would just add, look, compared to pandemic levels, surely not as attractive because the portfolio is more complex, it has a lot of absorption because the volume is much lower. So the current level of the margin from COVID should be not even close to where they were in the pandemic times.

是的。我想補充一點，與大流行水平相比，肯定沒有那麼有吸引力，因為投資組合更複雜，它有很多吸收，因為交易量要低得多。因此，目前與新冠病毒的差距水準應該還沒有接近大流行時期的水準。

Great. Appreciate it. And second question here also, I guess, on margins. And you gave some color earlier on Sarepta margin. But I guess when you remove the raw material pass-throughs there, maybe just on the gene therapy or drug substance business in general, how do we think about the -- can we remove the other pass-throughs? How do you think about the margin profile on gene -- drug substance versus fill/finish? And any differentials there?

偉大的。欣賞它。我想，第二個問題也是關於邊緣的。您早些時候在 Sarepta 邊緣給出了一些顏色。但我想，當你消除那裡的原料傳遞時，也許只是在基因治療或一般藥物業務上，我們如何考慮——我們可以消除其他傳遞嗎？您如何看待基因的邊緣概況—原料藥與填充/完成？那裡有什麼區別嗎？

So look, I would tell you that across the board of the drug substance piece, and as the gene therapy, protein mAbs margin are pretty much in the same zip code when you cut out the material pass-through, clearly, right? You have such a high volume of pass-through, you would all think it gets lower, but on the pure services side, I would say that there is pretty much a good alignment across the drug substance.

所以，我想告訴你，當你切掉材料傳遞時，整個藥物成分以及基因療法、蛋白質單株抗體的利潤幾乎都在相同的郵遞區號中，顯然，對吧？你的傳遞量如此之大，你都會認為它會降低，但在純粹的服務方面，我想說整個原料藥之間幾乎有很好的一致性。

I would say the drug product, there's a little bit of a different dynamic where the margin really depends -- being a very high-volume commercial industrial production system is very, very dependent on absorption, right? And so the margin itself of the products, I would say of the products we run, it's -- I mean, it's not big, the range, but there are products, like the vaccines or the GLP-1s, that because of the volume, they can drive a lot of absorption and a lot of margin uplift.

我想說的是藥品，利潤率真正取決於的動態有一點不同——作為一個非常大容量的商業工業生產系統非常非常依賴吸收，對嗎？因此，產品本身的利潤，我想說的是我們經營的產品，我的意思是，範圍並不大，但有些產品，如疫苗或 GLP-1，因為數量，它們可以推動大量吸收和大量利潤提升。

Our next question today comes from Max Smock of William Blair.

今天我們的下一個問題來自威廉布萊爾的馬克斯史莫克。

Congrats on the nice update. Just looking through Sarepta filing, it seems like R&D on ELEVIDYS has been about 4x as much as R&D on some of their other gene therapy programs. Just wondering if, based on this, is it fair to assume that something like 75% of total Sarepta revenue for you is tied to ELEVIDYS?

恭喜您取得了不錯的更新。只要瀏覽 Sarepta 的文件，ELEVIDYS 的研發費用似乎是其他一些基因療法計畫的研發費用的 4 倍左右。只是想知道，基於此，假設您 Sarepta 總收入的 75% 與 ELEVIDYS 相關是否公平？

And then in terms of that ELEVIDYS spend, is there any detail you can give us around what your fiscal 2024 revenue outlook that's tied ELEVIDYS to translates to from a dose perspective? I think there's quite a bit of uncertainty still out there in terms of how much it cost to manufacture the annual -- or the actual gene therapy. So any context there would be great.

然後，就 ELEVIDYS 支出而言，您是否可以向我們提供有關 ELEVIDYS 相關的 2024 財年收入前景從劑量角度轉化為何種細節的詳細資訊？我認為，就製造年度或實際基因療法的成本而言，仍然存在相當大的不確定性。所以任何背景都會很棒。

You take the first part.

你拿第一部分。

So from an overall perspective, we disclosed the Sarepta revenue, and you can get to the math, you can read the script, but it's about 90% of the revenue is ELEVIDYS, so it's 9001. So it's the lion's share, by far the lion's share, of the revenue of Sarepta. We do have other programs that are being developed and are in development, and we'll begin to grow more rapidly as we go forward.

所以從整體來看，我們披露了 Sarepta 的收入，你可以計算一下，你可以閱讀劇本，但大約 90% 的收入是 ELEVIDYS，所以是 9001。所以這是最大的份額，到目前為止Sarepta 收入的最大份額。我們確實還有其他正在開發和正在開發的項目，隨著我們的前進，我們將開始更快地發展。

As far as doses in patients, that's not something that we've commented on. And I don't think it's -- and Alessandro, I'll defer to you. But we fill an order that we're given by a customer. And that customer -- or that's our -- that's what we do. Now we study the market, we do look around corners, and we do assess it. But that's not something that I think we're going to discuss today.

至於患者的劑量，我們沒有評論過。我不認為這是－亞歷山德羅，我會聽從你的意見。但我們會填寫客戶給我們的訂單。那個客戶——或者說我們的客戶——就是我們所做的。現在我們研究市場，環顧四周，並對其進行評估。但這不是我認為我們今天要討論的問題。

Well said.

說得好。

Understood. Just to clarify, you said 90% ELEVIDYS?

明白了。澄清一下，你說的是 90% ELEVIDYS？

Yes, 90%. Yes, you can get to that math, but it's close...

是的，90%。是的，你可以得到這個數學，但它很接近......

Yes. Okay. Perfect. And then just following up a clarifying one. You mentioned a couple of minutes ago that it's easy to reconfigure the gene therapy capacity and that capacity is pretty fungible. I just wanted to confirm, you're saying it's easy to reconfigure for other gene therapy programs, right?

是的。好的。完美的。然後只是跟進一個澄清。您幾分鐘前提到，重新配置基因治療能力很容易，而且這種能力是相當可替代的。我只是想確認一下，你是說為其他基因治療程序重新配置很容易，對嗎？

And then while that may be the case, given some of the macro headwinds that we've seen, which I think most people would acknowledge have had an outsized impact on the broader cell and gene therapy space, how should we think about your ability to backfill that capacity if Sarepta's label doesn't actually end up getting expanded?

然後，儘管情況可能如此，但考慮到我們所看到的一些宏觀阻力，我想大多數人都會承認這對更廣泛的細胞和基因治療領域產生了巨大影響，我們應該如何考慮您的能力如果Sarepta的品牌最終沒有真正擴張，是否要回填該容量？

Yes. Look, first of all, I personally don't see these -- Sarepta is not binary dynamic as you guys are depicting, either extended or not extended. But I leave it like that. I believe there is a spectrum there that is more than just binary.

是的。看，首先，我個人不認為這些——Sarepta 並不像你們所描述的那樣是二元動態的，無論是擴展還是未擴展。但我就這樣離開了。我相信那裡有一個不僅僅是二進制的頻譜。

That being said, surely, it's the most fixed part of infrastructure are the suites. And the suites are designed in a way that can serve a number of different processes. What define the processes are the manufacturing units that are within the suites, and they are mostly mobile. So you can reconfigure them in -- pretty easily. So fundamentally, it's one of those facilities that we have in the network which have the highest grade of easiness to reconfigure and to be redeployed towards other programs should we need to do so.

話雖如此，毫無疑問，基礎設施中最固定的部分是套房。這些套件的設計方式可以服務許多不同的流程。定義流程的是套件內的製造單元，而且它們大多是移動的。所以你可以很容易地重新配置它們。因此，從根本上講，它是我們網路中擁有的設施之一，如果我們需要的話，它最容易重新配置並重新部署到其他程式。

At the moment, honestly, I don't have any visibility that we have to do so because we remain focused working around the clock to satisfy the demand of Sarepta.

目前，老實說，我不認為我們必須這樣做，因為我們仍在全天候工作以滿足 Sarepta 的需求。

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

我們的下一個問題來自美國銀行的 Derik De Bruin。

Just one clarifying question to start with, and I've got a couple of others. So what was embedded originally in your guide for 2024 for Sarepta from a dollar amount? And sort of like what's the incremental that's here now? Just wanted to get some -- math-ed a little bit all over the place. So that's the first part.

首先我要澄清一個問題，然後我還有其他幾個問題。那麼，您的 2024 年 Sarepta 指南中最初嵌入的金額是多少？有點像現在這裡的增量是多少？只是想在各處得到一些數學知識。這是第一部分。

From our original guidance today, it's remained unchanged.

從我們今天最初的指導來看，它保持不變。

Unchanged. So you'd already assumed that was going -- great. Okay. That's what I thought, just wanted to make sure.

不變。所以你已經假設這一切都會發生——太好了。好的。我也是這麼想的，只是想確認一下。

And how should we think about PCH margins progressing from here? A little bit lower than we thought in the quarter. How should we think about that moving?

我們應該如何看待 PCH 利潤率的發展？比我們本季的預期要低一些。我們該如何看待這項舉動？

PCH margins sequentially will go up through the year in the natural seasonality to the business model that they run and the business they bring in. In addition, we do have some cost structure initiatives going into PCH. And we also noted this new gummy contract, it was one with -- a very substantial contract that was won that will launch in the third quarter and be into our run rate in the fourth quarter. So we do believe that we've got the opportunity to generate those margins on a sequential improvement basis.

PCH 的利潤率將隨著其營運的業務模式和帶來的業務的自然季節性而逐年上升。此外，我們確實有一些針對 PCH 的成本結構舉措。我們還注意到這份新的軟糖合同，它是一份非常重要的合同，該合約將在第三季度啟動，並在第四季度納入我們的運行率。因此，我們確實相信我們有機會在連續改善的基礎上產生這些利潤。

Great. And then just one final one. So I'm looking at the consensus estimates for fiscal '25. The Street roughly has you increasing EBITDA by 35%. So that's, call it, a 16% margin at the midpoint of your current guide, that's 21-ish percent for fiscal '25.

偉大的。然後只有最後一件事。因此，我正在研究 25 財年的共識估計。華爾街大致預期 EBITDA 會增加 35%。也就是說，以目前指引的中位數計算，利潤率為 16%，相當於 25 財年的 21% 左右。

I mean, is that sort of 500 basis point gain in EBITDA margins realistic for next year, given where you see the business right now? And I ask this because I was certainly thinking the margin contribution on the Sarepta business was going to be a lot higher than it actually turns out to be. So just wondering any thoughts on how we should sort of think about EBITDA margin progression as we're exiting 2024.

我的意思是，考慮到您目前對業務的看法，明年 EBITDA 利潤率將成長 500 個基點是否現實？我問這個問題是因為我確實認為 Sarepta 業務的利潤貢獻將比實際情況高得多。因此，我想知道在 2024 年即將結束之際，我們應該如何考慮 EBITDA 利潤率的成長。

We talked about our exit run rate being more in line -- in our fourth quarter, more in line with our historic average. And so I think that's the best guidepost I can give you. We're not going to give a '25 update today or kind of look beyond the full year here today, fiscal year '24. But I think that's a good guidepost to use. If we get to that exit run rate that we talked about, you can use that as a benchmark to jump off from.

我們談到我們的退出運行率在第四季度更加符合我們的歷史平均值。所以我認為這是我能給你的最好的路標。我們今天不會發布 25 財年的最新情況，也不會展望全年（即 24 財年）。但我認為這是一個很好的指南。如果我們達到我們討論的退出運行率，您可以將其用作跳出的基準。

And the one point I can reiterate once again. Our margin reduction this year is not due to a portfolio shift, it's due to an operational dislocation which we have shared multiple times. And as John said, we have shared in these remarks, we are making very good progresses in addressing that. And probably the progress is faster than our initial expectations. So when you combine these 2 factors, you can make your own assessment.

我可以再次重申這一點。我們今年的利潤率下降並不是由於投資組合的轉變，而是由於我們多次分享的營運混亂。正如約翰所說，我們已經分享了這些言論，我們在解決這個問題方面正在取得非常好的進展。而且進展可能比我們最初的預期還要快。因此，當您結合這兩個因素時，您可以做出自己的評估。

The next question today comes from Paul Knight of KeyBanc.

今天的下一個問題來自 KeyBanc 的 Paul Knight。

Regarding Sarepta on next year, your -- a lot is booked through your fiscal year ending June. What portion of -- when does the second half of '24 get booked? And -- meaning, when do we get your FY '25 Sarepta book? Is it starting now? What visibility do you have beyond June of 2024 on Sarepta?

關於明年的 Sarepta，您的大量訂單已在截至 6 月的財政年度中預訂。 24 年下半年的哪一部分會被預訂？還有——意思是，我們什麼時候能拿到你的 25 財年 Sarepta 書？現在開始了嗎？ 2024 年 6 月之後，您在 Sarepta 上的可見度如何？

Yes. I think we've discussed, at a high level, we've had customer conversations around it. But we discussed how we actually book production. So our production is booked on a rolling 6-month basis. So that's why we feel really confident to how '24 is going to finish.

是的。我認為我們已經在高層進行了討論，我們已經圍繞著這個問題進行了客戶對話。但我們討論瞭如何實際預訂製作。因此，我們的生產是按 6 個月滾動預訂的。這就是為什麼我們對 24 週年的結局充滿信心。

And as we think about the Sarepta readout, and Alessandro made comments to his view on the Sarepta readout, where it's not maybe as binary as some are thinking. So I do think -- that's the comment I can give you on it. But we -- just fact-specific, we get the orders in on a rolling 6-month basis. As we work through the year, this year -- so as we work through this year, we'll get firmer orders that roll into '25.

當我們思考 Sarepta 讀數時，亞歷山德羅對他對 Sarepta 讀數的看法發表了評論，它可能並不像某些人想像的那樣二元化。所以我確實認為——這就是我可以給你的評論。但我們——只是針對特定事實，我們以 6 個月滾動的方式收到訂單。當我們努力完成今年的工作時，當我們努力完成今年的工作時，我們將獲得進入 25 年的更堅定的訂單。

Okay. And then regarding Brussels, you commented that, that was improving. Is that due to the biotech demand? Is it GLP-1s? Is it cell therapy? What's making Brussel improve?

好的。關於布魯塞爾，您評論說，情況正在改善。這是由於生物技術的需求嗎？是 GLP-1 嗎？是細胞療法嗎？是什麼讓布魯塞爾進步了？

So Brussel is a drug product facility, right? And yes, there is a GLP demand there, it's no secret, it's a public available information. Clearly, I believe that, in general, as we said before, the site is sitting on a very high level of demand because that has been posed in production for some time in the last fiscal year, right, was a big drain on our margin last year. And it's going back, right? So it's a fully utilized because we have backlog to recover on, it's going to take significant time. And yes, there is a lot of GLP demand. And I would tell you that the site is performing really well in satisfying the demand.

那麼布魯塞爾是一個藥品生產設施，對吧？是的，那裡有 GLP 要求，這不是秘密，而是公開資訊。顯然，我相信，總的來說，正如我們之前所說，該網站的需求量非常高，因為上一財年已經投入生產一段時間了，對吧，這對我們的利潤造成了很大的消耗去年。而且它會回去，對嗎？因此，它已充分利用，因為我們有積壓的工作需要恢復，這將需要大量時間。是的，有很多 GLP 需求。我想告訴您，該網站在滿足需求方面表現得非常好。

The next question comes from Eric Coldwell of Baird.

下一個問題來自貝爾德 (Baird) 的 Eric Coldwell。

I wanted to hit on 2 topics. The first is coming back to the COVID revenue. Sorry if I missed this, but did you comment on how the $100 million of Q1 revenue compared to your prior expectations or what was originally embedded in Street guidance? And then what changed to drive that upside or -- and/or the increase for the full year on the COVID side?

我想談兩個話題。首先是關於新冠疫​​情的收入。抱歉，如果我錯過了這一點，但是您是否評論過第一季 1 億美元的收入與您之前的預期相比如何，或者街道指導中最初包含的內容如何？那麼，是什麼變化推動了這一上漲或——和/或新冠疫情全年的成長？

I think when we guided for COVID, I think we took a fairly conservative assumption on COVID, not knowing where the season was going to go, number one. But we don't provide, as you know, individual guidance from a quarter perspective. But I'd say that it's come in stronger -- or it will come in strong in the first half. As I mentioned, it's just not as important to the back half of the year from a COVID perspective, from a COVID revenue perspective in what we're seeing today.

我認為，當我們對新冠疫情進行指導時，我認為我們對新冠疫情採取了相當保守的假設，第一，不知道這個賽季會走向何方。但如您所知，我們不提供季度角度的個人指導。但我想說的是，它變得更強了——或者說它會在上半場變得更強。正如我所提到的，從我們今天看到的新冠肺炎收入角度來看，這對今年下半年來說並不那麼重要。

Now as the season plays out this year, that's going to dictate demand at the end of our fiscal year, our fourth quarter, or second quarter calendar year next year. And we would be able to have more visibility as we work through the tail end of the COVID season here in our second quarter and calendar year fourth quarter. And I think it will dictate the season for next year.

現在，隨著今年季節的結束，這將決定我們財政年度末、明年第四季或第二季的需求。當我們在第二季和歷年第四季度過新冠疫情季節的尾聲時，我們將能夠獲得更多的可見性。我認為這將決定明年的季節。

Okay. And then on second topic on the gummy award. Just hoping we could get a little more on the nature of the award. Was that an expansion with an existing customer? A new relationship with a new customer? Was it a competitive takeaway from external or internal manufacturing? And finally, are these new launches from the partner? Or maybe that ties back to where this production is coming from that you have been awarded. Any additional details on timing or sizing? I know you said 3Q start, but it sounds like a pretty substantial deal for a segment that's been challenged. So I'm surprised it hasn't gotten a little more attention today.

好的。然後是關於軟糖獎的第二個主題。只是希望我們能夠更多地了解該獎項的性質。這是對現有客戶的擴張嗎？與新客戶建立新關係？這是外部或內部製造的競爭優勢嗎？最後，這些新產品是合作夥伴推出的嗎？或者這可能與您獲得獎項的作品的來源有關。有關時間或規模的其他詳細資訊嗎？我知道你說的是第三季開始，但這對一個受到挑戰的細分市場來說聽起來是一筆相當大的交易。所以我很驚訝它今天沒有得到更多的關注。

Yes. The gummy market has been down and continues to trend down, the markets continue down. This is a share gain. This is a new business for us from this customer. It's an already existing product and it's going to fit in perfectly into our network.

是的。軟糖市場已經下跌並繼續下跌，市場繼續下跌。這是股票收益。這是該客戶為我們帶來的一項新業務。它是一個已經存在的產品，它將完美地融入我們的網路。

We don't know have to add any SG&A per se on top of it, and it fits into the existing gummy network that we have and the open capacity that we have. So it's a kind of what I'd say is a no-brainer. it's got reasonably good margins. From a business perspective, it's got a very quick payback. So I think overall, it's a big win. doesn't require much CapEx either to go in. So it's pretty impressive.

我們不知道必須在其之上添加任何 SG&A 本身，它適合我們現有的黏性網路和我們擁有的開放容量。所以我想說這是理所當然的。它有相當不錯的利潤。從商業角度來看，它的回報非常快。所以我認為總的來說，這是一個巨大的勝利。也不需要太多的資本支出。所以它非常令人印象深刻。

Our next question comes from Rachel Vatnsdal of JPMorgan.

我們的下一個問題來自摩根大通的 Rachel Vatnsdal。

Great. Just one for me on PCH. So last year, you continuously flagged some of the inventory destocking, consumer discretionary spending headwinds. So can you walk us through, are you still seeing some of those headwinds impacting that business?

偉大的。 PCH 上只有我一個。因此，去年，您不斷指出了一些去庫存、非必需消費品支出的不利因素。那麼您能否向我們介紹一下，您是否仍看到一些影響該業務的不利因素？

And then just a follow-up on the earlier question around that commercial win on the gummy side. If we exclude that commercial win, how should we think about growth in consumer this year?

然後是對之前關於軟糖方面商業勝利的問題的後續回答。如果我們排除商業上的勝利，我們該如何看待今年消費者的成長？

So look, let me cover the first part of the question in terms of the headwinds. As we said in the prepared remarks, some of the macro environment that we have highlighted in November last year are still present. And we continue to see some prudent spend on side of our -- especially early stage, right, the early stage customers, are very prudent in progressing assets through the pipeline given the private funding environment.

那麼，讓我從逆風的角度來討論問題的第一部分。正如我們在準備好的演講中所說，我們去年 11 月強調的一些宏觀環境仍然存在。我們繼續看到一些謹慎的支出——特別是早期階段的客戶，在私人融資環境下，在透過管道推進資產方面非常謹慎。

The consumer environment is still not as it was before. But the reason why we have, in our own shop, excitement about the way we're going to continue to grow the company on an ex COVID basis is two-fold, really, right? So first of all, it's the pipeline, right? In PCH, we had a lot of products being approved, some very recently, which will drive a lot of growth in our pharmaceutical commercial business.

消費環境仍不如以前。但是，在我們自己的商店裡，我們對在新冠疫情爆發後繼續發展公司的方式感到興奮，原因有兩個，真的，對嗎？首先，它是管道，對嗎？在 PCH 中，我們有許多產品獲得批准，其中一些是最近才獲得批准的，這將推動我們的醫藥商業業務的大幅成長。

And share gain, right? We knew that over time, our existing relationship with a large consumer company which were not necessarily the natural market for Bettera, those customers, because of the relationship we have with Catalent and our brand, will with end up coming with us.

並分享收益，對嗎？我們知道，隨著時間的推移，我們與一家大型消費公司的現有關係不一定是 Bettera 的自然市場，但由於我們與 Catalent 和我們的品牌的關係，這些客戶最終將選擇我們。

So we have a little bit of a trend that is better than the market because of these main dynamics in PCH, and that's why we are confident about the ramp and the profile of the business as we go through the fiscal '24.

因此，由於 PCH 的這些主要動態，我們的趨勢比市場更好，這就是為什麼我們對 24 財年的業務成長和概況充滿信心。

Our last question today comes from Sean Dodge of RBC Capital Markets.

我們今天的最後一個問題來自加拿大皇家銀行資本市場的肖恩道奇。

This is Thomas Kelliher on for Sean. And apologies if these were covered, I got disconnected earlier. But I wanted to go back to the just tech transfers in Bloomington. Should we just consider these complete, or are there still some hurdles you need to clear to get these into full production? Any more detail there would be helpful.

我是 Thomas Kelliher 替肖恩 (Sean) 發言。如果這些內容被覆蓋，我很抱歉，我之前就斷線了。但我想回到布魯明頓的技術轉移。我們是否應該認為這些已經完成，或者您是否還需要清除一些障礙才能將它們投入全面生產？任何更多細節都會有幫助。

Well, first of all, I never said Bloomington, right? So it's -- and we already said in previous calls that some of those relationships are extended and expanded. So I would say that now this is something that is really touching all our network when it comes to sterile product. And we feel pretty good about it because it's really the way we want to serve our customers, with a network approach, not a site approach, which gives us a lot of flexibility and a lot of optionality for customers.

好吧，首先，我從來沒有說過布魯明頓，對吧？所以，我們在之前的電話會議中已經說過，其中一些關係得到了延伸和擴大。所以我想說，現在在無菌產品方面，這確實影響了我們所有的網路。我們對此感覺非常好，因為這確實是我們想要為客戶提供服務的方式，採用網路方法，而不是網站方法，這為我們提供了很大的靈活性和客戶的許多可選性。

So first of all, it's across the network. And yes, I do believe that those tech transfer activities could be deemed largely done. Of course on the first lines, so there will be more coming on the additional lines. But as I said, it's much easier because these are like-for-like assets to the current ones. And so yes, we're now going to start in the second half of the year in ramping up commercial volumes and really giving more supply to our customers.

首先，它是透過網路進行的。是的，我確實相信這些技術轉移活動可以被視為已基本完成。當然在第一行，所以後面的線路還會有更多。但正如我所說，這要容易得多，因為這些資產與當前的資產相當。所以，是的，我們現在將在今年下半年開始增加商業銷量，並真正為我們的客戶提供更多供應。

Thank you. We have no further questions in the queue, so I'll turn the call back over to CEO, Alessandro Maselli, for any closing remarks.

謝謝。我們沒有其他問題了，所以我會將電話轉回執行長亞歷山德羅·馬塞利 (Alessandro Maselli)，讓其發表結束語。

Thank you, everyone, for taking the time to join our call today. We are pleased to have delivered the solid financial performance this quarter while making operational improvement. At the same time, the strength of our pipeline and new commercial wins increase our confidence in fiscal '24 guidance, which we have reaffirmed.

謝謝大家今天抽空參加我們的電話會議。我們很高興本季實現了穩健的財務業績，同時改善了營運。同時，我們的管道實力和新的商業勝利增強了我們對 24 財年指導的信心，我們已經重申了這一點。

We remain focused on restoring Catalent's historical margins while driving the sustainable and profitable growth, increasing shareholder value and executing on our mission to improve the lives of patients every day. Thank you.

我們仍然專注於恢復康泰倫特的歷史利潤率，同時推動可持續的獲利成長、增加股東價值並履行我們改善患者日常生活的使命。謝謝。

This concludes today's call. Thank you for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的加入。現在您可以斷開線路。