Catalent Inc (CTLT) 2022 Q1 法說會逐字稿

Welcome, everyone, to the first quarter fiscal year 2022 earnings conference call. My name is Victoria, and I'll be coordinating your call today.

歡迎大家參加 2022 財年第一季度財報電話會議。我叫 Victoria，今天我會協調你的來電。

(Operator Instructions) I'll hand over to your host, Paul Surdez, Vice President of Investor Relations from Catalent to begin. Paul, please go ahead.

（操作員說明）我將交給您的主持人，Catalent 投資者關係副總裁 Paul Surdez 開始。保羅，請繼續。

Good morning, everyone, and thank you for joining us today to review Catalent's First Quarter 2022 Financial Results. Joining me on the call today are John Chiminski, Chair and Chief Executive Officer; and Tom Castellano, Senior Vice President and Chief Financial Officer. 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.

大家早上好，感謝您今天加入我們，回顧 Catalent 的 2022 年第一季度財務業績。今天和我一起參加電話會議的是主席兼首席執行官 John Chiminski；高級副總裁兼首席財務官 Tom Castellano。請在我們的補充演示文稿的幻燈片 2 上查看我們今天電話會議的議程，該演示文稿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 non-GAAP financial measures. It is possible that actual results could differ from management's expectations and 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 reconciliation to the most directly comparable GAAP measures. 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 made there on our operating results, performance and financial condition including those related to the COVID-19 pandemic.

在我們今天的電話會議中，管理層將做出前瞻性陳述並參考非 GAAP 財務措施。實際結果可能與管理層的預期不同，我們建議您參閱幻燈片 3，了解有關前瞻性陳述的更多詳細信息。幻燈片 4 和 5 討論了康泰倫特對非 GAAP 財務指標的使用，我們剛剛發布的收益報告提供了與最直接可比的 GAAP 指標的對賬。另請參閱今天將提交給美國證券交易委員會的 Catalent 的 10-Q 表格，以了解有關我們的經營業績、業績和財務狀況（包括與 COVID-19大流行相關的風險和不確定性）的更多信息。

Now I'll like to turn the call over to John Chiminski whose remarks will cover Slides 6 and 7 of the presentation.

現在我想把電話轉給 John Chiminski，他的發言將涵蓋演示文稿的幻燈片 6 和 7。

Thanks, Paul, and welcome to the call. Catalent began fiscal '22 with a strong start. Our first quarter financial results were driven by both our ongoing work and supportive global efforts to address the pandemic as well as our other critical work with our customers in delivering products and help people live better, healthier lives. In addition, we simultaneously continued to execute on our long-term growth strategy through organic investments and strategic acquisitions.

謝謝，保羅，歡迎來電。 Catalent 以強勁的開端開始了 22 財年。我們第一季度的財務業績受到我們為應對這一流行病而進行的持續工作和全球支持性努力的推動，以及我們與客戶在交付產品和幫助人們過上更好、更健康的生活方面開展的其他重要工作。此外，我們同時通過有機投資和戰略收購繼續執行我們的長期增長戰略。

Before I detail our specific achievements during the quarter, let me highlight our first quarter results.

在我詳細介紹本季度的具體成就之前，讓我強調一下我們第一季度的業績。

Our net revenue for the first quarter was just over $1 billion, increasing 21% as reported or 20% in constant currency compared to the first quarter of fiscal 2021. When excluding acquisitions and divestitures, organic growth was 23% measured in constant currency. Our adjusted EBITDA of $252 million for the first quarter increased 44% on both and as reported and constant currency basis compared to the first quarter of fiscal 2021. When excluding acquisitions and divestitures, organic growth was 52% measured in constant currency.

我們第一季度的淨收入略高於 10 億美元，與 2021 財年第一季度相比，按固定匯率計算增長 21% 或 20%。如果不包括收購和資產剝離，有機增長按固定匯率計算為 23%。與 2021 財年第一季度相比，我們第一季度調整後的 EBITDA 為 2.52 億美元，按報告和固定貨幣計算增長 44%。如果不包括收購和資產剝離，有機增長以固定貨幣計算為 52%。

Our adjusted net income for the first quarter was $128 million or $0.71 per diluted share, up from $0.43 per diluted share in the corresponding prior year period. The Biologics segment, driven by continued high demand from COVID-19 projects, was again the top contributor to Catalent's financial performance. This segment experienced organic net revenue growth of 44%, with segment EBITDA growing 56% from the first quarter of last year.

我們第一季度調整後的淨收入為 1.28 億美元或每股攤薄收益 0.71 美元，高於去年同期的每股攤薄收益 0.43 美元。在 COVID-19項目持續高需求的推動下，生物製劑部門再次成為 Catalent 財務業績的最大貢獻者。該部門的有機淨收入增長了 44%，該部門的 EBITDA 比去年第一季度增長了 56%。

Our Softgel and Oral Technologies segment resumed net revenue growth following the pandemic-related headwinds it experienced over the last year. Increased year-over-year demand for both prescription and consumer health products drove a 9% increase in net revenue within this segment during the first quarter of fiscal '22 compared to the first quarter of fiscal '21, which is highly encouraging. With net revenue up over last year, yet still down compared to the first quarter of 2020, this segment is still experiencing effects from the pandemic. However, we're seeing signs that these issues are transitory, and we're looking forward to continued improvement over time.

我們的 Softgel 和 Oral Technologies 部門在去年經歷了與流行病相關的不利因素後恢復了淨收入增長。與 21 財年第一季度相比，22 財年第一季度對處方藥和消費者保健產品的需求同比增長推動該部門淨收入增長 9%，這非常令人鼓舞。儘管淨收入比去年有所增加，但與 2020 年第一季度相比仍有所下降，該部門仍在受到大流行的影響。然而，我們看到這些問題是暫時的跡象，我們期待著隨著時間的推移持續改進。

Moving on now to our Oral and Specialty Delivery segment, where we also saw a return to organic net revenue growth after facing headwinds in fiscal 2021. As with Softgel and Oral Technologies, there are improving market dynamics across our Oral and Specialty Delivery segment, most notably this quarter in our early phase development offerings.

現在轉到我們的口服和特殊遞送部門，在 2021 財年面臨逆風之後，我們還看到了有機淨收入增長的回歸。與 Softgel 和 Oral Technologies 一樣，我們的口服和特殊遞送部門的市場動態正在改善，大多數特別是本季度我們的早期開發產品。

Finally, our Clinical Supply Services segment posted modest net revenue growth this quarter compared to the first quarter of fiscal '21, with profitability negatively impacted by the cost of opening our new full-service facilities in San Diego, California and Shiga, Japan. Both investments are poised to meet growing customer demand and are expected to be long-term growth drivers for this segment.

最後，與 21 財年第一季度相比，我們的臨床供應服務部門本季度的淨收入增長溫和，盈利能力受到我們在加利福尼亞州聖地亞哥和日本滋賀開設新的全方位服務設施的成本的負面影響。這兩項投資旨在滿足不斷增長的客戶需求，並有望成為該領域的長期增長動力。

On our last earnings call, we announced our agreement to acquire Bettera, a leading developer and manufacturer of consumer-preferred gummies, soft chews, and lozenges for nutraceutical, functional and botanical extract products for $1 billion. Following the completion of a successful debt raise, including additional term loans, whose proceeds we used in part to fund the acquisition, we closed the Bettera acquisition on October 1, making Catalent one of the leading independent suppliers in a high-growth, capacity-constrained portion of the nutraceutical and nutritional supplement market. This acquisition enables Catalent, and specifically, our Softgel and Oral Technology segment, to expand our existing substantial consumer health platform by adding the fast-growing consumer preferred dose format for nutritional supplements. This expansion also meets the evolving needs of our consumer health customers who have consistently asked Catalent for new additions to our product library, including gummies and other engaging formats, for the nutritional supplement and nutraceutical product concepts.

在我們上次的財報電話會議上，我們宣布同意以 10 億美元收購 Betera，Bettera 是一家領先的開發商和製造商，生產消費者喜愛的軟糖、軟糖和含片，用於營養保健品、功能性和植物提取物產品。在成功完成債務融資（包括額外的定期貸款，我們將其部分收益用於為收購提供資金）之後，我們於 10 月 1 日完成了對 Betera 的收購，使 Catalent 成為高增長、產能領先的獨立供應商之一。營養保健品和營養補充劑市場的受限部分。此次收購使 Catalent，特別是我們的軟膠囊和口服技術部門能夠通過添加快速增長的消費者首選的營養補充劑劑量形式來擴展我們現有的大量消費者健康平台。這種擴展還滿足了我們的消費者健康客戶不斷變化的需求，他們一直要求 Catalent 為我們的產品庫添加新的內容，包括軟糖和其他吸引人的形式，用於營養補充劑和保健產品概念。

As highlighted on our last call, acquiring Bettera enables us to increase our expectations for the long-term organic revenue growth rate in our Softgel and Oral Technology segment from 3% to 5% to 6% to 8%. This range is driven by the strength of our current advanced offerings in product libraries and is enhanced by the 20%-plus growth contribution we expect from Bettera over the next several years. This attractive growth rate from Bettera is accompanied by core EBITDA margins accretive to the segment. Combined, these factors lead us to expect the acquisition to be accretive to adjusted net income per share in the first year after close and significantly accretive thereafter.

正如我們在上次電話會議中所強調的那樣，收購 Betera 使我們能夠將我們對軟膠囊和口服技術部門的長期有機收入增長率的預期從 3% 提高到 5%，提高到 6% 到 8%。這一範圍是由我們當前在產品庫中提供的高級產品的實力推動的，並因我們預計 Betera 在未來幾年的 20% 以上的增長貢獻而得到加強。 Betera 的這種有吸引力的增長率伴隨著該部門的核心 EBITDA 利潤率增長。結合這些因素，我們預計此次收購將在交易完成後的第一年增加調整後的每股淨收入，並在之後顯著增加。

Our work streams integrating Bettera and supporting and accelerating its existing growth plans and the transition of approximately 500 experienced employees are now in full flight. As we integrate these new capabilities and its robust library of ready-to-market products, we're further solidifying Catalent's place as a partner of choice for consumer health companies across the globe. As we've already experienced significant customer interest in engaging in these new capabilities, we are considering accelerating our organic investment plans for these new and exciting offerings.

我們的工作流整合了 Betera 並支持和加速其現有的增長計劃以及大約 500 名經驗豐富的員工的過渡現在正在全面進行。隨著我們整合這些新功能及其強大的上市產品庫，我們進一步鞏固了康泰倫特作為全球消費者健康公司首選合作夥伴的地位。由於我們已經感受到客戶對使用這些新功能的濃厚興趣，我們正在考慮加快對這些令人興奮的新產品的有機投資計劃。

Next, I'll provide updates on a few organic investments in our Biologics segment that have progressed since our last call.

接下來，我將提供自我們上次電話會議以來取得進展的生物製品部門的一些有機投資的最新情況。

First, with respect to our biotherapeutics offerings. We previously detailed many of our upgrades at our growing campus in Bloomington, Indiana. These upgrades have served as the key growth driver for Catalent and have played a critical role in the global effort to bring the pandemic to an end, allowing us to quickly scale high-speed filling lines on behalf of our COVID-19 vaccine customers.

首先，關於我們的生物治療產品。我們之前詳細介紹了我們在印第安納州布盧明頓不斷發展的園區的許多升級。這些升級已成為 Catalent 的主要增長動力，並在全球結束大流行的努力中發揮了關鍵作用，使我們能夠代表我們的 COVID-19 疫苗客戶快速擴展高速灌裝線。

Just recently, we completed the addition of a new high-speed syringe filling line at the site, a project that we first announced in January 2019. This line is an additional source of growth for our Biologics segment, and like all of our existing syringe filling lines, it can be leveraged for a wide range of Biologics products, including COVID-19 vaccines.

就在最近，我們在現場完成了一條新的高速注射器灌裝線的添加，這是我們於 2019 年 1 月首次宣布的項目。這條線是我們生物製品部門的額外增長來源，就像我們現有的所有註射器一樣灌裝線，它可用於各種生物製品，包括 COVID-19 疫苗。

Given the strong demand for biotherapeutic manufacturing, we'll continue to invest in additional drug products and drug substance capacity at our Bloomington campus.

鑑於對生物治療藥物製造的強勁需求，我們將繼續在我們的布盧明頓校區投資於更多的藥品和原料藥產能。

Similarly, we continued to make organic investments at our 300,000 square foot facility in Anagni, Italy, which we originally purchased in January of 2020. When we acquired the site, it already benefited from years of steady investments that now support our Biologics capabilities as well as other assets and capabilities for oral solid dose forms, including high-capacity blister packaging and bottled cartoning solutions.

同樣，我們繼續對我們最初於 2020 年 1 月購買的位於意大利阿納尼的 300,000 平方英尺的設施進行有機投資。當我們收購該地點時，它已經受益於多年的穩定投資，這些投資現在也支持我們的生物製劑能力作為口服固體劑型的其他資產和能力，包括大容量泡罩包裝和瓶裝裝盒解決方案。

Since the acquisition, we've made significant investments in Anagni to meet growing customer demand for Biologics capacity. In 2020, we took action to meet the needs of multiple vaccine innovators, including several enhancements to existing capacity, to improve productivity and output. In February of this year, we began the rapid build-out of an additional high-speed bio-filling line, which has been qualified and will soon begin manufacturing.

自收購以來，我們對 Anagni 進行了大量投資，以滿足客戶對生物製劑產能不斷增長的需求。 2020 年，我們採取行動滿足多個疫苗創新者的需求，包括對現有產能進行多項提升，以提高生產力和產量。今年2月，我們又開始快速擴建一條高速生物灌裝線，該線已經通過，即將投產。

In addition to drug product investments, we announced a $100 million expansion project at our Anagni facility over the summer. The expansion will allow us to add Biologics drug substance manufacturing capability at the site, establishing our first drug substance capacity outside of the U.S. to support the growing European market demand for Biologics manufacture and supply. Ultimately, the expansion will house multiple single-use bioreactors, totaling 16,000 liters of total flexible manufacturing capacity, with the initial 4,000 liters expected to be completed in late fiscal 2023. The growth in investment at our Anagni site demonstrate how the COVID-19 pandemic has not only accelerated our strategic plans, but has also accelerated the return on investments we've made, enabling us to put additional cash to work to drive continued long-term growth. We also recently announced additional investments at our Gene Therapy Campus in Harmans, Maryland near the BWI airport. Early this calendar year, we completed construction in one building and campus, which now contains 10 multiroom commercial scale manufacturing suites.

除了藥品投資，我們還在今年夏天宣布了一項價值 1 億美元的 Anagni 工廠擴建項目。此次擴張將使我們能夠在現場增加生物製劑原料藥的生產能力，建立我們在美國以外的第一個原料藥產能，以支持歐洲市場對生物製劑生產和供應不斷增長的需求。最終，擴建將容納多個一次性生物反應器，總計 16,000 升的總靈活製造能力，最初的 4,000 升預計將在 2023 財年末完成。我們 Anagni 工廠的投資增長證明了 COVID-19 大流行如何不僅加快了我們的戰略計劃，而且還加快了我們所做投資的回報，使我們能夠投入額外的現金來推動持續的長期增長。我們最近還宣布對我們位於馬里蘭州哈曼斯 BWI 機場附近的基因治療園區進行額外投資。今年年初，我們完成了一座建築和園區的建設，現在包含 10 個多房間商業規模製造套房。

Given the high demand for manufacture of the growing number of gene therapy compounds and other products addressing new modes of treatment in the industry's development pipeline, we're increasing the number of manufacturing suites planned for the adjacent building from the 5 suites we initially announced to add 3 more commercial scale advanced Biologics manufacturing suites. This latest expansion will also include the construction of new storage capabilities for just-in-time inventory space, ultra-load temperature freezers to support a larger set of compounds and an expansion of overall infrastructure.

鑑於對製造越來越多的基因治療化合物和其他解決行業開發管道中新治療模式的產品的高需求，我們正在增加計劃在相鄰建築中建造的製造套房數量，從我們最初宣布的 5 個套房增加到增加 3 個商業規模的高級生物製品製造套件。這一最新的擴展還將包括為即時庫存空間構建新的存儲能力、支持更多化合物的超負荷溫度冷凍機以及整體基礎設施的擴展。

When completed at the end of calendar 2022, the campus will house a total of 18 cGMP manufacturing suites, each designed to accommodate multiple bioreactors up to 2,000 liter scale and enable the execution of commercial manufacturing from cell bank to purified drug substance. Given the growing scope of investment made to support the campus, the total size of this project to be spent over a multiyear period starting last year. It's now expected to be $360 million, up from the $130 million initially projected. This increase in investment was already factored into our initial fiscal 2022 CapEx plans discussed on our last earnings call.

到 2022 年年底完工時，該園區將共有 18 個 cGMP 製造套房，每個套房旨在容納多個最大 2,000 升規模的生物反應器，並能夠執行從細胞庫到純化藥物的商業製造。鑑於支持校園的投資範圍不斷擴大，從去年開始，該項目的總規模將花費多年。現在預計為 3.6 億美元，高於最初預計的 1.3 億美元。我們在上次財報電話會議上討論的初步 2022 財年資本支出計劃中已經考慮了投資的增加。

Finally, through the acquisition of RheinCell in August, we expanded our cell therapy offerings to include proprietary iPSC GMP cell line and technology to boost our current development and manufacturing capabilities to bring iPSC-based cell therapy to scale. We are receiving a good number of customer inquiries for this exciting new offering, and integration is tracking to our expectations.

最後，通過在 8 月收購 RheinCell，我們擴展了我們的細胞治療產品，包括專有的 iPSC GMP 細胞系和技術，以提高我們目前的開發和製造能力，從而使基於 iPSC 的細胞療法規模化。我們收到了大量客戶對這一激動人心的新產品的諮詢，並且整合符合我們的預期。

I'd now like to turn the call over to Tom, who will review our financial results for the first quarter and our fiscal '22 guidance, which we're raising to reflect the closing of the Bettera acquisition as well as our increased organic growth forecast for the remainder of the year.

我現在想把電話轉給湯姆，他將審查我們第一季度的財務業績和我們的 22 財年指導，我們正在提高這些指導以反映 Betera 收購的結束以及我們增加的有機增長對今年剩餘時間的預測。

Thanks, John. I'll begin this morning with a discussion on segment performance, where commentary around segment growth will be in constant currency.

謝謝，約翰。今天早上我將開始討論細分市場的表現，其中圍繞細分市場增長的評論將以不變的貨幣進行。

I will start on Slide 8 with the Biologics segment.

我將從幻燈片 8 的生物製品部分開始。

To highlight the company's transformation over the last 2 years, you will see that the segment represented 53% of our net revenue in Q1 of this fiscal year compared to 44% in Q1 of fiscal 2021 and 28% in Q1 of fiscal 2020. Biologics net revenue in Q1 of $546 million increased 44% compared to the first quarter of 2021, with segment EBITDA increasing 55% over the same period. This robust net revenue growth was organic and was driven by high demand for drug product and drug substance offerings in the U.S. and Europe, most notably for COVID-19 related programs, which continued to contribute to both development and commercial organic revenue growth. The segment's EBITDA margin increased significantly year-over-year to 30.3% compared to 28.2% in Q1 of the prior year, which is primarily attributable to increased capacity utilization and higher manufacturing volumes. We expect the Biologics segment growth rate to decelerate as the year progresses because we will begin to compare against the higher levels of demand from the back half of our last fiscal year.

為了突出公司在過去兩年的轉型，您會看到該部門在本財年第一季度占我們淨收入的 53%，而 2021 財年第一季度和 2020 財年第一季度分別為 44% 和 28%。Biologics net第一季度的收入為 5.46 億美元，與 2021 年第一季度相比增長了 44%，該部門的 EBITDA 同比增長了 55%。這種強勁的淨收入增長是有機的，是由美國和歐洲對藥品和原料藥產品的高需求推動的，尤其是對 COVID-19相關項目的需求，這些項目繼續為開發和商業有機收入增長做出貢獻。該部門的 EBITDA 利潤率同比大幅增長至 30.3%，而去年第一季度為 28.2%，這主要歸因於產能利用率提高和製造量增加。我們預計生物製品部門的增長率將隨著時間的推移而放緩，因為我們將開始與上一財年下半年的較高需求水平進行比較。

Please turn to Slide 9, which presents results from our Softgel and Oral Technologies segment.

請轉到幻燈片 9，它展示了我們的軟膠囊和口服技術部門的結果。

Softgel and Oral Technologies net revenue of $243 million increased 9% compared to the first quarter of 2021, with segment EBITDA increasing 9% over the same period. The increase was driven by growth in both prescription products and consumer health products, mainly in cough, cold and over-the-counter pain relief products. It is encouraging to see the start of a strong return for commercial demand, which despite growing 9% year-over-year is still below the segment's pre-pandemic level in the comparable first quarter of 2020. Development revenue continued to perform robustly as it has throughout the pandemic period and is a strong indicator for long-term growth in this segment. Segment EBITDA grew 9% and EBITDA margin was in line with the first quarter of the prior year.

Softgel 和 Oral Technologies 的淨收入為 2.43 億美元，與 2021 年第一季度相比增長了 9%，EBITDA 部門同期增長了 9%。這一增長是由處方產品和消費者保健產品的增長推動的，主要是咳嗽、感冒和非處方止痛產品。令人鼓舞的是，商業需求開始強勁回歸，儘管同比增長 9%，但仍低於 2020 年第一季度大流行前的水平。開發收入繼續表現強勁，因為它整個大流行期間都有，並且是該細分市場長期增長的有力指標。部門 EBITDA 增長 9%，EBITDA 利潤率與去年第一季度持平。

Slide 10 shows the results of the Oral and Specialty Delivery segment.

幻燈片 10 顯示了口腔和專業交付部分的結果。

Net revenue growth in the segment was again impacted by a challenging comparison against the prior year, where we had recorded revenue associated with a single product in our respiratory platform that was voluntarily recalled in September 2020. However, EBITDA had a favorable comparison due to $12 million of recall-related costs incurred in the first quarter of 2021. As the recalled product did not generate revenue after it was voluntarily recalled, this will be the last quarter for which it will impact the net revenue comparison in the segment, though favorable segment EBITDA comparison will likely continue as recall costs extended throughout fiscal 2021.

該部門的淨收入增長再次受到與上一年具有挑戰性的比較的影響，我們記錄了與 2020 年 9 月自願召回的呼吸平台中單一產品相關的收入。但是，EBITDA 有一個有利的比較，因為 12 美元2021年第一季度產生的召回相關成本為百萬美元。由於召回產品在主動召回後沒有產生收入，這將是最後一個影響該細分市場淨收入比較的季度，儘管該細分市場是有利的隨著召回成本在整個 2021 財年的延長，EBITDA 比較可能會繼續進行。

With that background, segment recorded net revenue of $146 million in the quarter, which was down 10% compared to the first quarter of fiscal 2021. Segment EBITDA was $33 million, a 48% increase over the first quarter of 2021. When factoring out the net impact from the divestiture of our blow-fill-seal business and the acquisition of Acorda's spray-drying assets, organic net revenue grew 3% and segment EBITDA more than doubled. The top line growth was primarily driven by elevated demand for early phase development programs. You may recall that a year ago, we called out lower demand for early phase development programs as a result of pandemic-related lockdowns. So this bounce back is another good indicator of a return of pre-pandemic activity.

在此背景下，該部門本季度的淨收入為 1.46 億美元，與 2021 財年第一季度相比下降了 10%。該部門的 EBITDA 為 3300 萬美元，比 2021 年第一季度增長了 48%。剝離我們的吹-灌-封業務和收購 Acorda 的噴霧乾燥資產的淨影響使有機淨收入增長了 3%，該部門的 EBITDA 增長了一倍以上。收入增長主要是由對早期開發項目的需求增加推動的。您可能還記得，一年前，由於與大流行相關的封鎖，我們呼籲降低對早期開發計劃的需求。因此，這種反彈是大流行前活動恢復的另一個良好指標。

As shown on Slide 11, our Clinical Supply Services segment posted net revenue of $96 million, representing 2% growth over Q1 in the prior year. This was driven by strong global demand in manufacturing and packaging services, partially offset by a decline in demand for storage and distribution services in Europe. North America saw an increase in storage and distribution demand in the quarter.

如幻燈片 11 所示，我們的臨床供應服務部門公佈的淨收入為 9600 萬美元，比去年第一季度增長 2%。這是由全球對製造和包裝服務的強勁需求推動的，部分被歐洲對存儲和分銷服務的需求下降所抵消。本季度北美的存儲和配送需求有所增加。

During the quarter, we opened 2 new full-service Clinical Supply facilities, one in San Diego and the other in Shiga, Japan. Costs related to these openings had an adverse impact on segment EBITDA and the segment EBITDA margin. As of September 30, 2021, backlog for the segment was $515 million compared to $501 million at the end of last quarter and up 20% from September 30, 2020. The segment recorded net new business wins of $109 million during the first quarter, a 10% increase compared to the first quarter of the prior year. The segment's trailing 12-month book-to-bill ratio is 1.3x.

本季度，我們開設了 2 個新的全方位服務臨床供應設施，一個在聖地亞哥，另一個在日本滋賀。與這些空缺相關的成本對分部 EBITDA 和分部 EBITDA 利潤率產生了不利影響。截至 2021 年 9 月 30 日，該部門的積壓訂單為 5.15 億美元，而上一季度末為 5.01 億美元，比 2020 年 9 月 30 日增長了 20%。該部門第一季度的新業務淨贏額為 1.09 億美元，與去年第一季度相比增長了 10%。該部門過去 12 個月的訂單出貨比為 1.3 倍。

Moving to our consolidated adjusted EBITDA on Slide 12.

轉到幻燈片 12 上的合併調整後 EBITDA。

Our first quarter adjusted EBITDA increased 44% to $252 million or 24.6% of net revenue compared to 20.6% of net revenue in the first quarter of fiscal 2021. On a constant currency basis, our first quarter adjusted EBITDA increased 44% compared to the first quarter of fiscal '21, while organic EBITDA growth was higher at 52%.

我們第一季度調整後的 EBITDA 增長了 44%，達到 2.52 億美元，占淨收入的 24.6%，而 2021 財年第一季度為淨收入的 20.6%。按固定匯率計算，我們第一季度調整後的 EBITDA 比第一季度增長了 44% 21 財年第四季度，EBITDA 有機增長率高達 52%。

As shown on Slide 13, first quarter adjusted net income was $128 million or $0.71 per diluted share compared to adjusted net income of $78 million or $0.43 per diluted share in the first quarter a year ago.

如幻燈片 13 所示，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，而去年第一季度調整後淨收入為 7800 萬美元或稀釋後每股收益 0.43 美元。

Slide 14 shows our debt-related ratios and our capital allocation priorities.

幻燈片 14 顯示了我們的債務相關比率和我們的資本配置優先級。

At the end of September, the company raised $1.1 billion in gross proceeds through incurrence of an incremental term loan and issuance of new senior notes at an attractive overall average rate of approximately 3%. We used most of the net proceeds to fund the Bettera acquisition, which was completed on October 1. This capital raise drove our cash, cash equivalents and marketable securities balance at September 30 just before the closing to be in excess of $2 billion compared to [$967 million] at June 30.

截至 9 月底，該公司通過增加定期貸款和發行新的優先票據籌集了 11 億美元的總收益，總體平均利率約為 3%。我們將大部分淨收益用於為 10 月 1 日完成的 Betera 收購提供資金。此次融資推動我們的現金、現金等價物和有價證券餘額在收盤前的 9 月 30 日超過 20 億美元，而 [ 9.67 億美元]，截至 6 月 30 日。

Our net leverage was 2.1x at September 30 compared to 2.2x at June 30. However, our reported cash balance and corresponding leverage ratios are artificially favorable due to the timing of the closing of the Bettera acquisition. When adjusting for this, our pro forma cash, cash equivalents and marketable securities balance as of September 30 would have been approximately $1 billion and our pro forma net leverage ratio would have been 3.0x, which aligns with our long-term leverage target. From here, we will naturally delever, providing us with significant flexibility to continue to pursue organic and inorganic growth opportunities.

我們的淨槓桿率在 9 月 30 日為 2.1 倍，而 6 月 30 日為 2.2 倍。但是，由於 Betera 收購的結束時間，我們報告的現金餘額和相應的槓桿比率人為有利。在對此進行調整時，我們截至 9 月 30 日的備考現金、現金等價物和有價證券餘額約為 10 億美元，我們的備考淨槓桿率為 3.0 倍，這與我們的長期槓桿目標一致。從這裡開始，我們自然會去槓桿化，為我們提供巨大的靈活性，以繼續尋求有機和無機增長機會。

Moving on to capital expenditures. We continue to expect CapEx to be approximately 15% to 16% of our 2022 net revenue expectations, driven primarily by growth investments in our Biologics segment, including the investments that John detailed earlier.

轉向資本支出。我們繼續預計資本支出將占我們 2022 年淨收入預期的 15% 至 16% 左右，這主要是由我們生物製品部門的增長投資推動的，包括約翰之前詳述的投資。

Now we turn to our fiscal outlook for fiscal 2022, as outlined on Slide 15, which has been updated to reflect the October 1 acquisition of Bettera as well as an increase in organic growth we are now forecasting in the back half of the year. We now expect full year net revenue in the range of $4.62 billion to $4.82 billion, representing growth of 16% to 21% versus our previous estimate $4.3 billion to $4.5 billion. We now project that net revenue growth from M&A will be 2 to 3 percentage points, driven by the acquisition of Bettera. Recall that our original guidance for M&A activity reflected a negative 1 to 2 percentage points impact as the divestiture of the blow-fill-seal business more than offset the expected upside from the multiple smaller acquisitions we completed in fiscal 2021.

現在我們轉向 2022 財年的財政展望，如幻燈片 15 所述，該展望已更新以反映 10 月 1 日對 Betera 的收購以及我們現在預測的下半年有機增長的增加。我們現在預計全年淨收入在 46.2 億美元至 48.2 億美元之間，比我們之前估計的 43 億美元至 45 億美元增長 16% 至 21%。我們現在預計，在收購 Betera 的推動下，併購帶來的淨收入增長將達到 2 到 3 個百分點。回想一下，我們最初對併購活動的指導反映了 1 到 2 個百分點的負面影響，因為吹-灌-封業務的剝離抵消了我們在 2021 財年完成的多項較小型收購帶來的預期上行空間。

We continue to project organic net revenue growth in each of our segments to be within or above the long-term growth range we have previously disclosed for each segment. For full year adjusted EBITDA, we expect a range of $1.225 billion to $1.295 billion, representing growth of 20% to 27% over fiscal 2021 compared to our previous estimate of $1.13 billion to $1.20 billion. We expect full year adjusted net income of $630 million to $695 million, representing growth of 15% to 27% over last year compared to our previous estimate of $585 million to $650 million. We continue to expect our fully diluted share count on a weighted average basis for fiscal 2022 to be in the range of 181 million to 183 million shares. This projection counts our Series A convertible preferred shares as these all were converted to common shares in accordance with their terms. Finally, we also continue to expect our consolidated effective tax rate to be between 23% and 25% for fiscal 2022.

我們繼續預測我們每個部門的有機淨收入增長將在我們之前為每個部門披露的長期增長范圍內或之上。對於全年調整後的 EBITDA，我們預計範圍為 12.25 億美元至 12.95 億美元，與我們之前估計的 11.3 億美元至 12.0 億美元相比，比 2021 財年增長 20% 至 27%。我們預計全年調整後淨收入為 6.3 億美元至 6.95 億美元，比我們之前估計的 5.85 億美元至 6.5 億美元增長 15% 至 27%。我們繼續預計 2022 財年我們完全攤薄後的股票數量在加權平均基礎上將在 1.81 億至 1.83 億股之間。該預測計算了我們的 A 系列可轉換優先股，因為這些都已根據其條款轉換為普通股。最後，我們還繼續預計 2022 財年的綜合有效稅率將在 23% 至 25% 之間。

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

接線員，我們準備好的發言到此結束。我們現在想開始提問。

(Operator Instructions) Our first question comes from Tycho Peterson from JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的第谷彼得森。

So my first one is pretty significant raise here after an in-line first quarter. If we take out the $150 million of Bettera this year, that still leaves around $170 million of organic upside to the prior top line guide. So just wanted to get your thoughts on the organic piece. Does this raise a function of seasonality in the business? Or are there other factors, such as vaccine boosters, that's driving this -- the raise?

所以我的第一個是在第一季度在線之後非常重要的加薪。如果我們今年剔除 Betera 的 1.5 億美元，那仍然為之前的收入指南留下約 1.7 億美元的有機上升空間。所以只是想了解一下您對有機產品的看法。這是否提高了業務的季節性功能？還是有其他因素（例如疫苗助推器）推動了這一增長？

Yes, sure. I'll take this one.

是的，當然。我要這個。

We did mention that the Bettera acquisition, in addition to first quarter beat that we saw along with continued strength from an organic perspective in the back half of the year. I would say, as we look across the business units, certainly, our Biologics continues to be performing extremely well. Given tailwinds related to COVID-19 vaccines that we mentioned, we expect to see as multi-duration revenue streams for us. But we've also seen, I would say, a positive recovery, as we highlighted in the prepared remarks, around OSD and our SOT segments as well as particularly around the consumer health side of the businesses, which were certainly challenged in fiscal '21 as a result of the global pandemic. So as we look across the portfolio, I really see -- I would really say we continue to see strength across all 4 of our segments, especially the 3 that I highlighted here, that are all contributing to the guidance rates on an organic basis.

我們確實提到了對 Betera 的收購，除了我們在今年下半年看到的第一季度業績以及從有機角度來看的持續增長。我想說的是，當我們審視各個業務部門時，我們的生物製品當然會繼續表現得非常好。鑑於我們提到的與 COVID-19 疫苗相關的有利因素，我們希望看到我們的長期收入來源。但我想說，正如我們在準備好的評論中強調的那樣，我們也看到了積極的複蘇，圍繞 OSD 和我們的 SOT 部門，特別是圍繞企業的消費者健康方面，這些業務在 21 財年肯定受到挑戰由於全球大流行。因此，當我們審視整個投資組合時，我真的看到了——我真的會說我們繼續看到我們所有 4 個細分市場的實力，尤其是我在這裡強調的 3 個細分市場，它們都在有機的基礎上為指導率做出了貢獻。

Gotcha. And then my last question would be, can you just elaborate on the demand environment for the organic softgel business? I think it was mentioned that some of the headwinds that you guys have seen, I'm sorry to abate, but we're still at pre-pandemic levels here. So can you just -- below pre-pandemic levels, so can you just sort of elaborate on the demand environment there?

知道了。然後我的最後一個問題是，您能否詳細說明有機軟膠囊業務的需求環境？我想有人提到你們看到的一些逆風，我很抱歉減弱，但我們仍處於大流行前的水平。那麼你能不能——低於大流行前的水平，那麼你能不能詳細說明那裡的需求環境？

Sure. Yes. No. We continue to be very pleased with what we're seeing out of the SOT segment. This is the second consecutive quarter where we've seen a return to organic growth. We saw organic growth of 9% in the first quarter, which is nicely above the long-term outlook of that segment. And I would say the demand profile remains positive, as I mentioned. That was certainly one of the factors that we took into consideration when raising the guidance for the second half of the year. So the fact that we're still below where we were in 2020, I think it provides us even more confidence that there's still growth to come here on the horizon. And we're certainly, as I said, seeing strength across this business on the consumer high as the recovery continues. So expecting a strong back half of the year from this business.

當然。是的。不，我們仍然對我們在 SOT 領域看到的情況感到非常滿意。這是我們連續第二個季度恢復有機增長。我們在第一季度看到了 9% 的有機增長，這大大高於該領域的長期前景。正如我所提到的，我會說需求狀況仍然是積極的。這當然是我們在提高下半年指導時考慮的因素之一。因此，我們仍低於 2020 年的水平這一事實，我認為這讓我們更有信心，即地平線上仍有增長。正如我所說，隨著復甦的繼續，我們肯定會看到整個行業在消費者高位上的實力。因此，預計該業務將在下半年表現強勁。

And our next question comes from Jacob Johnson from Stephens.

我們的下一個問題來自 Stephens 的 Jacob Johnson。

Maybe first, a bigger picture question for John. In his recent book, Scott Gottlieb, talked about CDMOs having incremental excess manufacturing capacity to support vaccine and therapeutic manufacturing in case another pandemic presents itself. Is this something that would make sense for Catalent? Would you be interested in it? And maybe what would it take for you to participate in something like that?

也許首先，約翰有一個更宏觀的問題。斯科特·戈特利布 (Scott Gottlieb) 在他最近的一本書中談到了 CDMO 具有增量的過剩製造能力，以支持疫苗和治療藥物的製造，以防另一場大流行病出現。這對 Catalent 有意義嗎？你會對它感興趣嗎？也許你需要什麼才能參與這樣的活動？

Well, let me just say one of the major drivers behind the CDMO industry is having the right capacity and the right capability. It's a significant driver for the business. And when we came into the pandemic, we were in the enviable position of having built out our strategic plans and putting -- we're putting in place significant capacity for our Biologics business, both on the drug substance side and the drug product side. What I can tell you, without responding directly to the question with regards to vaccines and Scott Gottlieb's book, I will just tell you that we're constantly looking at the market. We're constantly looking at what our customers' needs are. And as a management team, working closely with our Board. We're looking out in the future to understand what strategic investments that we need to make so that we will have the capacity necessary for our customers and their pipelines. And obviously, demonstrated itself in how Catalent was able to play a significant role in the manufacture of vaccines for multiple customers.

好吧，我只想說 CDMO 行業背後的主要驅動力之一是擁有合適的容量和合適的能力。它是業務的重要驅動力。當我們進入大流行時，我們處於令人羨慕的位置，我們已經制定了我們的戰略計劃並投入——我們正在為我們的生物製品業務建立重要的能力，無論是在原料藥方面還是在藥品方面。我可以告訴你的是，在不直接回答有關疫苗和 Scott Gottlieb 的書的問題的情況下，我只會告訴你我們一直在關注市場。我們一直在關注客戶的需求。作為一個管理團隊，與我們的董事會密切合作。我們展望未來，了解我們需要進行哪些戰略投資，以便我們擁有客戶及其管道所需的能力。顯然，Catalent 證明了自己如何能夠在為多個客戶生產疫苗方面發揮重要作用。

Got it. And then maybe on the non-COVID side. A lot of focus on BWI and Anagni and Bloomington. So maybe I'll ask one just on Madison. Can you just update us on your efforts there? And then can you remind us, are you supporting any commercial therapies out of that location?

知道了。然後可能在非 COVID 方面。很多人關注 BWI、Anagni 和 Bloomington。所以也許我會問一個關於麥迪遜的問題。你能告訴我們你在那裡的努力嗎？然後你能提醒我們，你是否支持該地點以外的任何商業療法？

Yes. So a key strategic priority for us is to bring in a commercial product into our Madison site. As you know, we've completed out both our fourth and fifth trains at the site. We have a very robust pipeline there. We were hopeful that one of the products that we actually had there for a COVID therapy would actually get emergency use authorization. That has not happened yet, but we're very confident over the next 12 to 18 months, we should be able to secure our commercial product there.

是的。因此，我們的一個關鍵戰略優先事項是將商業產品引入我們的麥迪遜網站。如您所知，我們已經在現場完成了第四和第五列火車。我們在那裡有一個非常強大的管道。我們希望我們實際擁有的用於 COVID 治療的產品之一能夠真正獲得緊急使用授權。這還沒有發生，但我們非常有信心在接下來的 12 到 18 個月內，我們應該能夠在那裡確保我們的商業產品。

We have very good business there. But as you know, when you're only working in the clinical space, the work there can be somewhat lumpy depending on the clinical trial. So really, the desire for us to have a commercial product at the site is just to make sure that we have a stable base load, if you will. And we're confident that we'll be able to get it soon.

我們在那裡的生意很好。但正如您所知，當您只在臨床領域工作時，根據臨床試驗的不同，那裡的工作可能會有些不穩定。所以說真的，如果你願意的話，我們希望在現場擁有商業產品只是為了確保我們有一個穩定的基本負載。我們有信心很快就能拿到它。

And our next question comes from David Windley from Jefferies.

我們的下一個問題來自 Jefferies 的 David Windley。

You called out John and Tom, you called out in your prepared remarks, development acceleration in both SOT and OSD, that development activity seems to be robust and attractive there. And then you also have 20% year-over-year backlog growth in the CSS segment. So all of those seem to point toward a nice future revenue opportunity. I was hoping you could shine maybe a little bit more light on that in terms of cycle time and your guidance. You commented on the guidance that kind of alludes to that. But perhaps you could talk about how that unfolds over the next several quarters.

你召集了 John 和 Tom，你在準備好的發言中呼籲，SOT 和 OSD 的開發加速，那裡的開發活動似乎是強大和有吸引力的。然後你在 CSS 部分也有 20% 的同比積壓增長。因此，所有這些似乎都指向一個不錯的未來收入機會。我希望你能在周期時間和你的指導方面更清楚地說明這一點。你評論了那種暗示的指導。但也許你可以談談在接下來的幾個季度中如何展開。

So Dave, good to hear from you. I would just say that both of these businesses are businesses where we do significant development work, both for SOT and OSD. And that usually is a precursor for potential products going commercial. So we can't call whether it's going to be within the next quarter or 2 over the next year. But what we're increasingly confident is that we're seeing a return to the long-term growth rates that we expect out of both of these businesses. As you know, on the SOT business was the one business that we had within Catalent that really was affected by the pandemic as it has slower prescription launches.

戴夫，很高興收到你的來信。我只想說，這兩個業務都是我們為 SOT 和 OSD 進行重要開發工作的業務。這通常是潛在產品商業化的先兆。所以我們不能說它是在下個季度還是在明年的 2 年內。但我們越來越有信心的是，我們看到這兩項業務都將恢復到我們預期的長期增長率。如您所知，SOT 業務是我們在 Catalent 中擁有的一項業務，它真正受到大流行的影響，因為它的處方發布速度較慢。

And also, we had -- our consumer health business was not seeing demand as people were in lockdowns and not traveling and not purchasing their normal cough, cold and other products. And so that is starting to come back, combined with, I would say, more activity from a development standpoint that we see both in SOT and OSD. So we're confident that we're going to be able to continue with the long-term growth targets that we have for both of those businesses. And as you know, we're going to take up our long-term growth target for the SOT business from 3% to 5% to 6% to 8% with the acquisition of Bettera. So that really does significantly enhance that segment.

而且，我們有——我們的消費者健康業務沒有看到需求，因為人們處於封鎖狀態，沒有旅行，也沒有購買他們正常的咳嗽、感冒和其他產品。因此，這開始回歸，我想說，從我們在 SOT 和 OSD 中看到的開發角度來看，我們看到了更多的活動。因此，我們有信心能夠繼續實現我們為這兩項業務制定的長期增長目標。如您所知，我們將通過收購 Betera 實現 SOT 業務的長期增長目標，從 3% 到 5% 到 6% 到 8%。因此，這確實顯著增強了該細分市場。

That's helpful. My follow-up is around your gene therapy business and the BWI facilities. Your CapEx costs for the incremental 3 suites that you're talking about today is -- the simple math would suggest that it's quite a bit more -- that each of those are quite a bit more expensive. You mentioned storage and some ultra low temp freezers and things like that. Is that what drives up the extra costs? Or are these suites going to be more specialized in what they can do? I wondered if you could talk about the extra costs for the incremental.

這很有幫助。我的後續行動圍繞您的基因治療業務和 BWI 設施展開。您今天談論的增量 3 套件的資本支出成本是——簡單的數學表明它要多得多——每一個都貴得多。你提到了存儲和一些超低溫冰箱之類的東西。這是推高額外成本的原因嗎？或者這些套件是否會更加專業化？我想知道你是否可以談談增量的額外成本。

Yes, sure, Dave. Tom here, I can jump in. I will say -- well, first of all, I would say that the new amount of $360 million are taken into consideration and the outlook we gave related to our CapEx investments in the fiscal year, that's 15% to 16%. So no change to that as a result of this. And this will be investment that has already started, so had -- contribution in fiscal '21 will continue in fiscal '22 as well as fiscal '23.

是的，當然，戴夫。湯姆，我可以插話了。我會說 - 好吧，首先，我會說考慮到新的 3.6 億美元數額以及我們給出的與本財年資本支出投資相關的前景，即 15 % 至 16%。因此，不會因此而改變。這將是已經開始的投資，所以已經開始了——21 財年的貢獻將在 22 財年和 23 財年繼續。

To answer on the increase in costs, I would say, we've certainly improved the layout of these suites, which have substantially increased the costs of it, but also have given us more and more flexibility in being able to meet the needs of our customers. I'd also say that there are additional investments related to warehouses, to parking garages and things that we need to be able to make sure we can keep up with pace of growth and hiring that's going to be needed at the site, that's also contemplated in that investment. So those are the types of things that are driving the costs up to that $360 million, but as I said, already contemplated in the outlook we've given around CapEx there.

要回答成本增加的問題，我想說，我們當然改進了這些套房的佈局，這大大增加了它的成本，但也給了我們越來越多的靈活性，能夠滿足我們的需求顧客。我還要說的是，還有與倉庫、停車場和我們需要的東西相關的額外投資，以確保我們能夠跟上現場需要的增長和招聘步伐，這也在考慮之中在那項投資中。因此，這些是將成本推高至 3.6 億美元的因素，但正如我所說，我們已經在我們圍繞資本支出給出的前景中考慮到了這一點。

Yes. And Dave, just as a follow-on to that. So one side of it is the CapEx investment that you're querying on. The other side is what are the drivers behind it. And what I would tell you is we just continue to see and experience very robust demand for our gene therapy business. If we just take a look at the overall pipeline, there's more than 300 new gene therapy assets that entered into the pipeline in 2021. And we see that pipeline growing from about 900 assets to about 2,900 assets, if you were to go all the way out to 2027 with the kind of work that we do and understand the overall pipeline. So we feel really good about these investments. And clearly, it's going to make us a leader in the overall gene therapy development and manufacturing area.

是的。戴夫，作為後續。因此，一方面是您正在查詢的資本支出投資。另一方面是它背後的驅動因素。我要告訴你的是，我們只是繼續看到並體驗到對我們基因治療業務的非常強勁的需求。如果我們只看一下整個管道，到 2021 年將有 300 多項新的基因治療資產進入管道。我們看到管道從大約 900 項資產增長到大約 2,900 項資產，如果你一路走下去的話到 2027 年，我們所做的工作和了解整個管道。所以我們對這些投資感覺非常好。顯然，這將使我們成為整個基因療法開發和製造領域的領導者。

And our next question comes from Tejas Savant from Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Tejas Savant。

Maybe I'll start with one on Bettera for you, Tom. Is it about sort of $150 million contribution a fair way to think about it in terms of what's embedded for the 3 quarters in this fiscal year? And now that Bettera is closed, can you give us some color on early customer conversations?

湯姆，也許我會先為你介紹 Bettera。就本財年第 3 個季度的內嵌內容而言，大約 1.5 億美元的捐款是否是一種公平的思考方式？現在 Betera 關門了，你能給我們一些關於早期客戶對話的顏色嗎？

John, I believe, in your prepared remarks, you mentioned something about a planned acceleration of investments there. Is that -- can you just share some color on that? And is that sort of expected to weigh on margins here a little bit?

約翰，我相信，在你準備好的發言中，你提到了一些關於那裡計劃加速投資的事情。那是——你能分享一些顏色嗎？那種預期會影響這裡的利潤率嗎？

Sure. Thanks for the question, Tejas. Look, we haven't split out the increase of the $320 million to the guidance between what is Bettera contribution and what is the base business. However, I will say, directionally, you are in the right place in terms of how you're thinking about this. We were very pleased to be able to get the acquisition closed on October 1 and expected to see a full 9-month contribution here. And as we said, around this business when we announced the acquisition back in August, this is a business that is growing at 20-plus percent organically, at EBITDA margins in the near 30% or low 30% range, approaching that of our Biologics business. So hopefully, that's enough color to give you to be able to help you model the contributions. And just as a reminder, as we report our results for the second quarter, we will be calling out the Bettera acquisition here as a part of our SOT segment that will be treated as inorganic.

當然。謝謝你的問題，Tejas。看，我們還沒有將 3.2 億美元的增長拆分為 Betera 貢獻和基礎業務之間的指導。但是，我要說的是，就您對此的思考方式而言，您是在正確的位置。我們很高興能夠在 10 月 1 日完成收購，並期望在這裡看到完整的 9 個月的貢獻。正如我們所說，當我們在 8 月份宣布收購時，圍繞這項業務，這是一項有機增長超過 20% 的業務，EBITDA 利潤率接近 30% 或低於 30%，接近我們的生物製劑商業。希望這些顏色足以讓您能夠幫助您對貢獻進行建模。提醒一下，當我們報告第二季度的業績時，我們將在這裡宣布對 Betera 的收購，作為我們 SOT 部門的一部分，該部門將被視為無機部門。

And Tejas, just as I did with Tycho, I'll provide you a little backdrop to the overall dynamics. We continue to see with Bettera and the overall gummy soft chew, lozenge area that there is a significant demand that is currently outpacing capacity. There just isn't enough capacity out there for the demand that you have. I mean, gummies have grown to a 30 billion dose marketplace here in the U.S. So as we got our hands on Bettera, one, we've had significant reach outs from, I would say, very well-known, high-profile customers who are looking to Catalent to really help them continue to build out their franchises or get into the franchise. And so in my prepared remarks, what I'm alluding to is the fact that, as we move forward with this integration, we may even accelerate some of the investment plans that we have contemplated during our due diligence period because now that we're into this a month or so, we have even more visibility to the customer demand and needs of that business.

還有 Tejas，就像我對 Tycho 所做的那樣，我將為您提供一些整體動態背景。我們繼續看到 Betera 和整體軟糖咀嚼片、錠劑領域的需求量很大，目前已經超過了產能。只是沒有足夠的容量來滿足您的需求。我的意思是，軟糖在美國已經發展到一個 300 億劑量的市場所以當我們拿到 Betera 時，我們已經從非常知名的知名客戶那裡獲得了很大的影響，他們希望 Catalent 能夠真正幫助他們繼續建立特許經營權或進入特許經營權。因此，在我準備好的發言中，我指的是這樣一個事實，即隨著我們推進這種整合，我們甚至可能會加快我們在盡職調查期間考慮的一些投資計劃，因為現在我們在這一個月左右的時間裡，我們對客戶需求和該業務的需求有了更多的了解。

So this is one where we can very effectively deploy additional CapEx and quickly gain market share as well as grow the business potentially faster than our original business case. So we're extremely excited about this. It really enhances and transforms our SOT business segment and we look forward to continuing to do the integration. And as I said, potentially accelerate the investment plans that we had contemplated before the acquisition.

因此，這是我們可以非常有效地部署額外的資本支出并快速獲得市場份額以及可能比我們原來的業務案例更快地發展業務的案例。所以我們對此感到非常興奮。它確實增強和轉變了我們的 SOT 業務部門，我們期待繼續進行整合。正如我所說，有可能加快我們在收購前考慮的投資計劃。

Got it. Very helpful. And Tom, another quick one for you on the guide. Can you give us a sense to what extent you're baking in any supply chain disruptions or inflationary pressures in wages as well as a strong flu season here?

知道了。很有幫助。湯姆，指南中的另一個快速指南。你能告訴我們你在多大程度上受到供應鏈中斷或工資通脹壓力以及嚴重的流感季節的影響嗎？

Yes. So all of those items are certainly, I would say, are taken into consideration, Tejas. In the guidance, I would say we've been very conservative in what we've assumed from a wage inflationary perspective. In this guidance, we certainly continue to see material challenges. We've done a very good job, I would say, internally by staying ahead of those. And obviously, we're able to pass some of that on where we have the ability to. So everything reflected, as we know today, related to inflationary pressures included in the guidance, I wouldn't expect any further headwinds to be talked about through the remainder of the year around this based on the approach we've taken and what we've included.

是的。所以我想說的是，所有這些項目肯定都會被考慮在內，Tejas。在指南中，我想說我們從工資通脹的角度來看我們的假設非常保守。在本指南中，我們當然會繼續看到物質挑戰。我們做得非常好，我想說，在內部保持領先地位。顯然，我們能夠將其中的一些傳遞到我們有能力的地方。因此，正如我們今天所知，所有反映的內容都與指南中包含的通脹壓力有關，根據我們採取的方法和我們所採取的措施，我預計在今年餘下的時間裡不會再討論任何不利因素。已經包括在內。

The other thing, related to your question around strong flu season, I would say this is certainly part of maybe a little bit of the strength we're seeing within the consumer health side of the business, within SOT, where we talked about a little bit of a recovery around cough, cold, pain medications that we've seen here. But that's really it in terms of the contribution and tailwind. That's already, again, contemplated and reflected in the revised guidance with the strength in the second half across the SOT segment.

另一件事，與你關於強流感季節的問題有關，我想說這肯定是我們在業務的消費者健康方面看到的力量的一部分，在 SOT 中，我們討論了一些我們在這裡看到的咳嗽、感冒和止痛藥有所恢復。但就貢獻和順風而言，確實如此。這已經再次考慮並反映在修訂後的指導方針中，下半年 SOT 領域的實力很強。

And Tejas, just, again, bringing it up to a higher level. On the overall supply chain, certainly, we now have most of the world talking about supply chain issues. I would say Catalent was out in front very early in the pandemic, doing the work that we needed to do to secure our materials throughout the pandemic. And going forward, I will tell you, it continues to be a relatively -- a relative challenge for us, but we put in place very strong operating mechanisms. We have engagement at the highest levels of management, working with our suppliers to ensure that we get the components that we need. You probably have heard people talk about single-use components, specifically on the drug product and drug substance side being a challenge. But again, we have strong working relationships with everyone.

而 Tejas，再次將其提升到更高的水平。在整個供應鏈上，當然，我們現在有世界上大多數人都在談論供應鏈問題。我想說，Catalent 在大流行病的早期就走在了前面，做了我們需要做的工作，以在整個大流行病期間保護我們的材料。展望未來，我會告訴你，這對我們來說仍然是一個相對的挑戰，但我們建立了非常強大的運營機制。我們與最高管理層進行接觸，與我們的供應商合作以確保我們獲得所需的組件。您可能聽說過人們談論一次性成分，特別是在藥品和原料藥方面是一個挑戰。但同樣，我們與每個人都有牢固的工作關係。

But when we look at the overall supply challenges, we, along with most CEOs, see the supply chain challenges continuing out through the end -- probably the second half of 2022. From a Catalent perspective, this also means that we've had to make additional investments from an overall inventory standpoint, which obviously impacts our working capital. But they're the right investments, if you will, necessary to ensure that we continue to reliably supply across all fronts from vaccine through the 7,000 other products that we manufacture.

但是，當我們審視整體供應挑戰時，我們和大多數 CEO 都認為供應鏈挑戰將持續到年底——可能是 2022 年下半年。從康泰倫特的角度來看，這也意味著我們不得不從整體庫存的角度進行額外投資，這顯然會影響我們的營運資金。但如果您願意的話，它們是正確的投資，是確保我們繼續可靠地從疫苗到我們生產的 7,000 種其他產品的各個方面的供應所必需的。

And now we will move over to John Kreger from William Blair.

現在我們將從 William Blair 轉到 John Kreger。

Guys, could you just give us an update on your latest thinking on vaccine production? I know you don't want to get into this specifically. But just curious if you're thinking about this as a business that grows further in the coming year, levels off or declines a bit.

伙計們，您能否向我們介紹一下您對疫苗生產的最新想法？我知道你不想專門討論這個。但是，如果您將此視為來年進一步增長、趨於平穩或略有下降的業務，我只是好奇。

Yes. So John, I would just say that, as I've said on previous calls, it's increasingly clear that the vaccines are going to be here to stay for quite a while. There's still a large part of the population that needs to be vaccinated. There's the need for boosters. There are now new formats that are coming out compared to where we were at the beginning of the vaccine distribution. And also, we see that there's a potential for the COVID vaccine to be [married] with an annual flu vaccine. So I would say that from a Catalent perspective, we see this as really a new franchise for the company. And we think advanced vaccines in general, with the advent of 2 approved mRNA vaccine, so advanced vaccines are going to be, again, an important franchise for the company going forward. So I hope that clears things up a little bit for you.

是的。所以約翰，我只想說，正如我在之前的電話會議上所說的那樣，越來越清楚的是疫苗將在這裡停留很長一段時間。仍有很大一部分人口需要接種疫苗。需要助推器。與我們在開始分發疫苗時的情況相比，現在出現了新的格式。而且，我們看到 COVID 疫苗有可能與年度流感疫苗[結合]。所以我想說，從 Catalent 的角度來看，我們認為這真的是公司的一個新特許經營權。我們認為，隨著 2 種批准的 mRNA 疫苗的出現，先進疫苗總體上將成為公司未來的重要特許經營權。所以我希望這能為您解決一些問題。

It does. And maybe as a follow-up, if you think about your -- the different sort of buckets within your Biologics business, I know you've said demand is quite good across the board. Where are you seeing the greatest sort of lean times as clients bring you new orders and sort of, what are the plans to alleviate that?

確實如此。也許作為後續行動，如果你考慮你的 - 你的生物製品業務中的不同類型的桶，我知道你已經說過全面的需求非常好。當客戶給您帶來新訂單時，您在哪裡看到最大的精益時期，有什麼緩解計劃？

Yes. Well, again, I'll just go back to the fact that the strategic planning within Catalent, I think, is literally top quartile, if not top 10% in terms of our market landscaping, our understanding of what our customer needs are and the capacity that we need to put in place. We're guiding to -- about 15%, 16% of our CapEx is going to be -- 15% to 16% of our revenue is going to be deployed towards CapEx this year. And we're in constant dialogue with our Board. Every Board meeting has some component of the strategic capacity needs and CapEx that we'll need to follow on. So we're in regular dialogue here and I would just say Catalent is doing an excellent job just as we did before the pandemic, having capacity that was covered and making sure that we continue to have the right capacity for our customers on a go-forward basis.

是的。好吧，再一次，我要回到一個事實，我認為 Catalent 的戰略規劃在我們的市場規劃、我們對客戶需求的理解以及我們需要建立的能力。我們正在指導 - 大約 15%，我們資本支出的 16% 將是 - 今年我們收入的 15% 到 16% 將用於資本支出。我們一直在與董事會進行對話。每次董事會會議都有我們需要跟進的戰略能力需求和資本支出的某些組成部分。所以我們在這裡進行定期對話，我只想說 Catalent 做得很好，就像我們在大流行之前所做的那樣，擁有涵蓋的能力，並確保我們繼續為我們的客戶提供合適的能力——前向基礎。

And the next question comes from Jack Meehan from Nephron.

下一個問題來自 Nephron 的 Jack Meehan。

Just was hoping to get your thoughts, how did the quarter play out versus your expectation. Obviously 23% organic growth is nothing to stop at. And you're raising the full year organic growth, but the quarter revenue did come in a little below our forecast on The Street. Was there anything that came in a little lighter than expected? Or any timing dynamics you would call out?

只是希望得到您的想法，本季度的結果與您的預期相比如何。顯然，23% 的有機增長勢不可擋。你提高了全年的有機增長，但季度收入確實略低於我們在華爾街的預測。有沒有比預期輕一點的東西？或者你會調用任何時間動態？

Jack, I would just say this quarter was really, very closely aligned to our internal expectations. I think as we look at the first quarter historically and this -- and into the future, it has and will continue to be our seasonably lightest quarter from a volume perspective given many of the months as part of the first quarter or in the middle of the summer months will be shutdowns at our facility, shutdowns at facilities within our customers' network as well. I would say as we look at the performance here now, what we saw from a margin expansion perspective in the first quarter was we were very pleased with. We're expecting 120 basis points of margin expansion at the midpoint of our guidance on a full year basis, and we've had the strongest first quarter margin we never had as a company. So I don't think, as I look through things, there was anything that came in necessarily lighter than where we expected. And this was really right down the middle of the fairway in terms of management's expectation.

傑克，我只想說這個季度真的非常符合我們的內部預期。我認為，當我們回顧第一季度的歷史和這個 - 以及未來時，從數量的角度來看，它已經並將繼續成為我們季節性最輕的季度，因為作為第一季度的一部分或中期的許多月份夏季將關閉我們的設施，也關閉我們客戶網絡內的設施。我想說，當我們現在看這裡的表現時，從第一季度利潤率擴張的角度來看，我們非常滿意。我們預計全年利潤率將在我們指導的中點擴大 120 個基點，而且我們的第一季度利潤率是我們公司從未有過的最高水平。所以我不認為，當我審視事物時，有任何事情一定比我們預期的要輕。就管理層的期望而言，這確實處於中途。

Well, Jack, let me maybe just put a really clear (inaudible) on this one. This was an extremely strong start to our fiscal year. And as Tom said, it was really what we had from an overall expectation standpoint and having been in the seat for 12 years, I would say again, this was on the strong -- this was the strongest start to a fiscal year that we've had. So we're very pleased with the results.

好吧，傑克，讓我在這個問題上說得非常清楚（聽不清）。這是我們財政年度的一個非常強勁的開端。正如湯姆所說，從整體預期的角度來看，這確實是我們所擁有的，並且已經擔任該職位 12 年，我要再說一遍，這是強勁的 - 這是我們財政年度最強勁的開端已經有。所以我們對結果非常滿意。

Great. And then just one more follow-up on the COVID contribution within guidance. Is your -- was that portion kind of unchanged within the core guidance raise? And I'm just looking at the development sales within Biologics were down $20 million sequentially. Was that related to COVID? Any dynamics that you would call out?

偉大的。然後再對指南中的 COVID 貢獻進行一次跟進。您的 - 核心指導加薪中的那部分是否沒有變化？我只是在看 Biologics 的開發銷售額連續下降了 2000 萬美元。這與 COVID 有關嗎？您會提出任何動態嗎？

Yes, Jack. We're going to stay away from giving any more specifics around COVID and what the contributions were in the second half of the year. As I said, the strength that we saw in the first quarter, the demand profile we continue to see across both development and commercial programs, drug substance and drug product as well as viral vector manufacturing within Biologics gave us the confidence and comfort to be able to increase the organic growth rate we expect to see in the second half of the year. And as John said, we're going to start the year in fiscal '22 from our first quarter, a seasonally lightest quarter perspective, the way we have gave us that much more confidence in being able to increase the full year outlook as part of guidance. In addition, as I mentioned earlier as well, our SOT and OSD segments continue to perform well, and that was taken into consideration from a fiscal '22 guidance increase standpoint as well.

是的，傑克。我們將避免提供有關 COVID 的更多細節以及今年下半年的貢獻。正如我所說，我們在第一季度看到的實力，我們在開發和商業項目、原料藥和藥物產品以及生物製品中的病毒載體製造中繼續看到的需求概況，讓我們有信心和安慰能夠以提高我們預計在今年下半年看到的有機增長率。正如約翰所說，我們將從我們的第一季度開始 22 財年，這是一個季節性最輕的季度視角，我們讓我們更有信心能夠增加全年展望的一部分指導。此外，正如我之前提到的，我們的 SOT 和 OSD 部門繼續表現良好，並且從 22 財年指導增長的角度也考慮到了這一點。

And now we'll move on to Paul Knight from KeyBanc Capital Markets to ask his...

現在我們將繼續向 KeyBanc Capital Markets 的 Paul Knight 詢問他的...

John, could you talk about the proportion of business in Biologics that's still unfinished and would it not be fairly (inaudible) the barriers to entry in that part of the market are probably picking up your need for CapEx.

約翰，你能談談生物製品中尚未完成的業務比例嗎？這部分市場的進入壁壘可能會增加你對資本支出的需求，這是否公平（聽不清）。

Yes. So first of all, I would say that in our Biologics business, clearly, for, I would say, our non-gene therapy business that the drug product is the largest proportion of our overall revenues comparing to our product -- to drug substance. But when you take a look at our gene therapy business in the totality of our drug substance, it has a significant amount of drug substance capacity. And obviously, in my prepared remarks, we detailed out the fact that we have 10 suites now there and that we were adding another 5 suites, but we're now moving that up to a total of 8 suites. So between that in our investments that we're making in Anagni, which again, I detailed out in my prepared remarks, we are now starting to have, I would say, a lot more of our drug substance in the future -- or I'm sorry, a lot more of our Biologics revenues in the future will start coming from the drug substance, but the drug product is the largest part of that overall revenue in the segment.

是的。因此，首先，我想說的是，在我們的生物製品業務中，我想說的是，對於我們的非基因治療業務，與我們的產品相比，藥品在我們總收入中所佔的比例最大——原料藥。但是當你從我們的原料藥的整體來看我們的基因治療業務時，它具有大量的原料藥能力。顯然，在我準備好的發言稿中，我們詳細說明了我們現在有 10 間套房，並且我們正在添加另外 5 間套房，但我們現在將總數增加到 8 間。因此，在我們對 Anagni 進行的投資之間，我在準備好的發言中再次詳細說明，我想說，我們現在開始擁有更多的原料藥——或者我對不起，我們未來更多的生物製品收入將開始來自原料藥，但藥品是該部門總收入的最大部分。

And I would just say, again, that from a drug product standpoint, getting a filling line up and running is usually best case a 2- to 3-year endeavor depending on whether or not you have (inaudible) in an existing facility or you need to build out a greenfield facility, then you need to have advanced order on a line, which can take again up to 2 years. And then you have to go through the installation and the overall qualification. So getting out ahead of that drug product capacity is a very big deal. And we do see very strong demand going forward in the the future given -- apart from the vaccines, given the very strong Biologics drug product roadmap, which is increasing at very, very strong double-digit rates the overall pipeline is. So again, it's a constant dialogue, both internally from a market landscaping standpoint and strategic standpoint, knowing what capacity we have to put in place, and then strong dialogues with our Board in terms of supporting the overall CapEx.

我只想說，再一次，從藥品的角度來看，建立和運行灌裝線通常是最好的情況，需要 2 到 3 年的努力，具體取決於您是否（聽不清）現有設施或您需要建立一個新建設施，然後你需要在生產線上提前訂購，這可能又需要長達 2 年的時間。然後你必須通過安裝和整體資格。因此，超越藥品產能是一件大事。我們確實看到未來的需求非常強勁——除了疫苗，考慮到非常強大的生物製劑藥物產品路線圖，整個管道正在以非常、非常強勁的兩位數速度增長。因此，這又是一次持續的對話，無論是從市場規劃的角度還是戰略的角度來看，了解我們必須具備的能力，然後在支持整體資本支出方面與我們的董事會進行強有力的對話。

And what I can assure you, from an overall growth standpoint, that Catalent knows what it needs to do to put on online capacity to ensure that we have the capacity that our customers need for their overall pipelines. And then, I'll just remind you that the capacity that we purposed for the vaccine work clearly is fungible for other Biologics drug product filling. So we feel really good about the assets that we've put in place and are going to put in place. And the final comment is that we continue to state that for us, COVID and the vaccine work really accelerated our strategic plans. And it also accelerated the invest -- the returns on those investments, allowing us to put even more of that cash to work organically and even inorganically. So I hope that answers your question.

我可以向你保證，從整體增長的角度來看，Catalent 知道需要做什麼來增加在線容量，以確保我們擁有客戶對其整體管道所需的容量。然後，我只想提醒您，我們用於疫苗工作的能力顯然可以用於其他生物製劑藥物產品的灌裝。因此，我們對已經到位和將要到位的資產感到非常滿意。最後的評論是，我們繼續聲明，對我們來說，COVID 和疫苗工作確實加速了我們的戰略計劃。它還加速了投資——這些投資的回報，使我們能夠將更多的現金用於有機甚至無機的工作。所以我希望這能回答你的問題。

Yes. And on -- you had mentioned earlier, the new formats in vaccine is -- the COVID vaccine, is it plural? Are they going to single-dose formats?

是的。還有——你之前提到過，疫苗的新形式是——COVID 疫苗，它是複數形式嗎？他們會採用單劑量形式嗎？

So they're certainly going down to lower dose formats within the vials. They want to take it down from the higher number of doses to lower number of doses as you have -- it becomes more challenging for them to basically do the pause and then use the vaccines and the vials in a short period of time. So they're coming down to lower number of doses. And then certainly, they're also going to single-dose prefilled syringe format. So again, that's ongoing work by our customers, and clearly Catalent is looped in there, and I can't really detail a lot more than that. I would just say that there is a continuing change within the formats. And as I said, we've been hearing discussions about a combination of the COVID vaccine with flu vaccine. So that could be an annual COVID vaccine from that standpoint.

所以他們肯定會減少到小瓶內的較低劑量形式。他們想像你一樣從較高劑量減少到較低劑量——對他們來說，基本上暫停然後在短時間內使用疫苗和小瓶變得更具挑戰性。所以他們正在減少劑量。然後當然，他們也將採用單劑量預填充注射器格式。再次重申，這是我們的客戶正在進行的工作，很明顯 Catalent 在那裡循環，我不能再詳細說明了。我只想說格式在不斷變化。正如我所說，我們一直在聽到有關將 COVID 疫苗與流感疫苗結合使用的討論。因此，從這個角度來看，這可能是一種年度 COVID 疫苗。

We will now move on to Sean Dodge from RBC Capital Markets.

我們現在將轉到 RBC Capital Markets 的 Sean Dodge。

This is Thomas Kelliher on for Sean. So maybe going back to gene therapy. As you guys continued to build up this new capacity and sort of thinking over the longer term and given the relative complexity involved in the manufacturing, what kind of EBITDA margins do you expect gene therapy to contribute relative to the 30% or so we're seeing across all of Biologics today? Basically, how do you expect those margins for gene therapy to look relative to the rest of Biologics?

這是肖恩的托馬斯凱利赫。所以也許回到基因治療。隨著你們繼續建立這種新的能力並進行長期思考，並考慮到製造過程中涉及的相對複雜性，相對於我們 30% 左右的 EBITDA 利潤率，你們期望基因療法能帶來什麼樣的利潤？今天看到所有的生物製品嗎？基本上，您如何看待基因療法相對於其他生物製劑的利潤率？

Yes. Tom, it's a level of disclosure. It's a little bit below what we've talked about publicly. I will say, our Biologics business continues to have the most robust EBITDA margins that we really have across the portfolio, in the low to mid-30s, with the potential of expanding north of that. We've talked about the company overall of being able to drive towards a 28% EBITDA margins by fiscal 2024. I'd say we're well on pace for that. And margin expansion opportunity across our Biologics segment, inclusive of the cell and gene therapy business is certainly going to contribute and be probably one of the main drivers of that EBITDA margin expansion that we'll see across the company. So hopefully, that gives you some direction as you think about the margins of that subsegment in the Biologics business.

是的。湯姆，這是一定程度的披露。這比我們公開談論的要低一點。我要說的是，我們的生物製品業務繼續擁有我們在整個投資組合中真正擁有的最強勁的 EBITDA 利潤率，在 30 年代中期到中期，並有可能向北擴展。我們已經談到公司整體能夠在 2024 財年之前將 EBITDA 利潤率提高到 28%。我想說我們正在朝著這個目標邁進。我們生物製品部門的利潤率擴張機會，包括細胞和基因治療業務，肯定會做出貢獻，並且可能成為我們將在整個公司看到的 EBITDA 利潤率擴張的主要驅動力之一。因此，希望這能為您考慮生物製品業務中該細分市場的利潤率提供一些指導。

Okay. That's fair. And then you all mentioned plans to hire additional kind of technical and operational expertise over the next few years to support some of the investments in gene therapy. What is the typical kind of profile you're looking for? Does everyone need to be kind of a highly sought after scientist or expert? Or are you able to kind of leverage a lot of the existing talent and expertise you already have?

好的。這還算公平。然後你們都提到了在未來幾年內聘請其他類型的技術和運營專家的計劃，以支持對基因治療的一些投資。您正在尋找什麼樣的典型個人資料？每個人都需要成為備受追捧的科學家或專家嗎？或者您是否能夠利用現有的大量人才和專業知識？

Yes. So I'll first state that Catalent over the last couple of years in a row has hired more than 4,000 people from the outside. So we are constantly recruiting into Catalent the necessary resources we need to run the business, and we've been very effective at doing that. Also note that we have very high internal referral rates. When we take a look at our last year's external hires of about 4,500 people, we had about 1/3 of those -- 30% of those came from internal referrals for an external candidate. When we take specifically a look at our business, we really have kind of 2 sets of people that we need to hire. First of those that are experienced and qualified from an overall biopharma GMP standpoint, with regard to, I would say, everything from biologist to come as to microbiologist, both within our quality organization, which has a very high demand. And then, obviously, those that are actually doing the innovation and product development, which are at a much higher level.

是的。所以我首先要聲明，Catalent 在過去幾年連續從外部聘用了 4,000 多人。因此，我們不斷地向 Catalent 招聘我們運營業務所需的必要資源，而且我們在這方面做得非常有效。另請注意，我們的內部推薦率非常高。當我們查看去年約 4,500 名外部僱員時，我們發現其中約有 1/3——其中 30% 來自外部候選人的內部推薦。當我們具體審視我們的業務時，我們確實有兩類人需要雇用。首先是那些從整體生物製藥 GMP 的角度來看有經驗和合格的人，我想說的是，從生物學家到微生物學家的一切，都在我們的質量組織內，這有很高的要求。然後，很明顯，那些實際上在進行創新和產品開發的人處於更高的水平。

These are at the Ph.D. and advanced degree level. And certainly, those that have had experience and we have obviously a strong pool of those candidates that are in the U.S. And I would just say that Catalent's overall brand has made us an employer of choice for them. On the other side, we also need to have, I would say, capable operators. These are folks that, in some cases, do not need to be degreed, but in some cases, actually do need to be degreed depending on the work that they're doing from a gene therapy standpoint. So we actually have them in the suites and operating. And again, these can be degreed, and in some cases, not degreed depending on the overall work. But it's a huge operational effort from a talent and acquisition standpoint that, I would say, Catalent is well positioned for given the amount of hires that we've had over the last several years and we'll continue to have into this year. And so far, we've been able to meet those needs, quite frankly, at a lower cost, I'm sure, than many in terms of acquiring their talent.

這些是博士學位。和高級學位水平。當然，那些有經驗的人，我們顯然在美國有很多候選人，我只想說 Catalent 的整體品牌使我們成為他們的首選雇主。另一方面，我想說，我們還需要有有能力的操作員。這些人在某些情況下不需要獲得學位，但在某些情況下，實際上確實需要獲得學位，這取決於他們從基因治療的角度所做的工作。所以我們實際上將它們放在套件中並進行操作。再次強調，這些可以分級，在某些情況下，不分級取決於整體工作。但從人才和收購的角度來看，這是一項巨大的運營努力，我想說，考慮到我們在過去幾年中招聘的員工數量，而且今年我們將繼續招聘，Catalent 處於有利地位。到目前為止，坦率地說，我們已經能夠以更低的成本滿足這些需求，我敢肯定，在獲得他們的人才方面比許多人要低。

Our next question comes from George Hill calling from Deutsche Bank.

我們的下一個問題來自德意志銀行的 George Hill。

John, just one, as you think about Biologics capacity and M&A. If we look at like the last decade or so, we've seen a lot of would-be Biologics manufacturers kind of build out their own capacity. Does a lot of this capacity become fit for purpose if you guys want to buy it? Is it too fragmented and kind of does it speed you guys to market from a capacity perspective, if you will, to kind of buy capacity in place versus building? Kind of -- I'd love if you just kind of talk about the opportunity to buy capacity from still biotech companies.

約翰，就一個，當你考慮生物製劑能力和併購時。如果我們回顧過去十年左右的時間，我們已經看到很多潛在的生物製品製造商都在建立自己的能力。如果你們想買的話，很多這種容量是否適合用途？從容量的角度來看，它是否過於分散，是否會加快你們進入市場的速度，如果你願意的話，購買到位的容量而不是建設？有點——如果你只是談談從靜止的生物技術公司購買產能的機會，我會很高興。

Well, as you know, Catalent is -- has a very strong overall inorganic or M&A activity. So we're constantly looking and know the assets that are available out there. And generally speaking, on the drug substance side, these can be somewhat fungible assets versus highly specific. These are, I would say, similar to things that can't be repurposed. From a Catalent perspective, we've discussed the fact that we'd love to find the right asset on drug substance side outside of the U.S., Western Europe, where we don't have a position today. And ultimately, within our Anagni facility, we're building that out. I would also say that, obviously, valuations and multiples are extremely high in the marketplace. So we have to weigh out, making sure that we buy -- the asset literally has to be somewhat close to perfection, if you will, given the high multiples and then the alternative is obviously putting our own capital to work from an organic standpoint. And on the drug substance side, that has really been our preferred mode of going after it.

好吧，正如你所知，Catalent 是——具有非常強大的整體無機或併購活動。因此，我們一直在尋找並了解可用的資產。一般來說，在原料藥方面，這些在某種程度上可能是可替代資產，而不是高度特定的資產。我會說，這些類似於無法重新利用的東西。從 Catalent 的角度來看，我們已經討論了這樣一個事實，即我們希望在美國、西歐以外的藥物物質方面找到合適的資產，我們今天在這些地方沒有位置。最終，在我們的 Anagni 設施內，我們正在構建它。我還要說的是，顯然，市場上的估值和倍數都非常高。因此，我們必須權衡，確保我們購買——如果你願意的話，資產實際上必須在某種程度上接近完美，考慮到高倍數，然後另一種選擇顯然是從有機的角度讓我們自己的資本發揮作用。在藥物方面，這確實是我們追求它的首選方式。

I also mention that from a drug substance standpoint, we're really focused on that sub 5,000 liter category, where more than a majority of the current Biologics pipeline, about 70%, if those molecules get approved, given the, I would say, smaller nature of the disease populations for the indications that they're going after, will require 5,000 liters or less drug substance manufacturing if those products get approved. So that's really the category that we continue to go after. That being said, as we continue to bring on more drug substance and work these trains effectively, we certainly will be able to take on, I would say, even higher volume drug substance. But again, we continue to look for the right assets. But we've been very effective in our strategic and growth plans, building out organically on the drug substance side.

我還提到，從藥物物質的角度來看，我們真正關注的是 5,000 升以下的類別，如果這些分子獲得批准，那麼超過目前生物製劑管道的大部分，大約 70%，鑑於，我會說，如果這些產品獲得批准，針對他們所追求的適應症的疾病人群性質較小，將需要 5,000 升或更少的原料藥生產。所以這確實是我們繼續追求的類別。話雖這麼說，隨著我們繼續引進更多的藥物並有效地工作這些火車，我想說，我們當然能夠承擔更多的藥物。但同樣，我們繼續尋找合適的資產。但我們的戰略和增長計劃一直非常有效，在原料藥方面有機地發展。

We will now move on to Derik De Bruin from Bank of America.

我們現在將轉到美國銀行的 Derik De Bruin。

You guys have some pretty tough comps in the second half of fiscal '22. And just sort of philosophically on this one -- I mean, or not philosophically, but I guess, can you just -- are you expecting to see positive organic revenue growth in the back half of the year and what it's all in just given the comp situation?

你們在 22 財年下半年有一些非常艱難的競爭。只是從哲學上講——我的意思是，或者不是哲學上的，但我想，你能不能——你是否期望在今年下半年看到積極的有機收入增長，以及它的全部內容補償情況？

So Derik, I think you're right. And certainly, we'll see some more challenging comps around the third quarter and the fourth quarter given the strength we saw in those businesses in the prior year as we started to really see the emergency use authorization volume for COVID-related vaccines start to pick up. We did mention specifically in our prepared remarks that we would not expect to see as we get into the back half of the year the Biologics segment continue to grow at the levels that we saw in the fourth quarter of last year and the first quarter of this year here. However, I will say we do continue to see strength on within our SOT and OSD businesses that we expect to carry into the back half of the year from an organic growth perspective. So the last thing I'll maybe highlight here is that, typically, a year for Catalent is 40-60 in terms of revenue contribution.

所以德里克，我認為你是對的。當然，考慮到去年我們在這些業務中看到的實力，我們將在第三季度和第四季度看到一些更具挑戰性的公司，因為我們開始真正看到 COVID 相關疫苗的緊急使用授權量開始回升向上。我們確實在我們準備好的評論中特別提到，當我們進入今年下半年時，我們不希望看到生物製劑部門繼續以我們在去年第四季度和今年第一季度看到的水平增長年在這裡。然而，我要說的是，我們確實繼續看到我們的 SOT 和 OSD 業務的實力，我們預計從有機增長的角度來看，這些業務將延續到今年下半年。所以我在這裡可能要強調的最後一件事是，通常情況下，就收入貢獻而言，Catalent 的一年是 40-60。

This year, maybe feels a little bit more balanced, not quite 50-50, but a little bit more balanced there. So hopefully, I've given you enough color to maybe solve the equation there. But I think we'll fall short of letting you know what the revenue expectations and growth is going to be in the back half of the year as we don't guide first half, second half specifically or quarterly. But we will certainly see a deceleration of the revenue growth from the levels we've seen here in the first quarter. The other thing we did highlight though to give you and The Street a little more comfort is the results of raising our fiscal '22 guidance is not only related to Bettera acquisition and the strength we saw in the first quarter but that we do continue to see a more accelerated organic growth in the back half of the year versus what we thought 60 days ago when we put out our previous fiscal '22 guidance.

今年，可能感覺更平衡一些，不是 50-50，但那裡更平衡一些。所以希望我已經給了你足夠的顏色來解決那裡的方程式。但我認為我們不會讓你知道今年下半年的收入預期和增長情況，因為我們沒有具體指導上半年、下半年或季度。但我們肯定會看到收入增長從第一季度的水平下降。我們確實強調的另一件事雖然讓你和華爾街更加欣慰，但提高我們 22 財年指引的結果不僅與 Betera 收購和我們在第一季度看到的實力有關，而且我們確實繼續看到與 60 天前我們發布之前的 22 財年指南時的想法相比，今年下半年的有機增長速度更快。

And as you think about the long-term growth rate in Biologics, is it 10% to 15%. If you think about the guidance for -- not the guidance, if you think about the long-term guide is 10% to 15% in -- for the Biologics segment. If you look at -- if you think about going into fiscal '23 and like there, once again, it's sort of a comp question again. I mean, do you expect -- would you expect to the '23 levels to be somewhere in that range of that? Or is there a potential step down just going to give them the comps? Once again, it's a question on just can you turn this existing COVID capacity that you have now and flip that over to other products? Or do you expect this sort of likely overall category to continue to grow?

當你考慮生物製劑的長期增長率時，它是 10% 到 15%。如果你考慮的指導——不是指導，如果你考慮長期指導是生物製品部分的 10% 到 15%。如果你看——如果你考慮進入 23 財年並且喜歡那裡，這又是一個補償問題。我的意思是，您是否期望 - 您是否期望 23 年的水平處於該範圍內？或者是否有可能下台只是為了給他們補償？再一次，這是一個問題，你能否將你現在擁有的現有 COVID 容量轉移到其他產品上？還是您預計這種可能的整體類別會繼續增長？

Yes. So Derik, obviously, we're not in a position at this time to be able to comment on more specificity around our fiscal '23 guidance and what that will look like. We'll continue to highlight that. We did raise our long-term growth outlook from 6% to 8% to 8% to 10% last quarter as a result of the robust demand that we see across the business. I will say we do have additional capacity that's going to be coming online across the business here in late fiscal '22 and into that fiscal '23 year, which we certainly think will help us continue to see strong performance in fiscal '23. We're going to fall short of giving you more specifics in terms of quantifying that, but again, continue to see COVID demand as having a multiyear duration. We're still in very early stages in terms of worldwide vaccine populations and what we're seeing from a booster demand perspective as well as younger age populations getting approved for the vaccine, et cetera, continue to give us confidence that this is going to be around for a multiyear duration, including into the fiscal '23 year.

是的。所以德里克，很明顯，我們目前無法就我們的 23 財年指南的更多細節以及它的外觀發表評論。我們將繼續強調這一點。由於我們在整個業務中看到的強勁需求，上個季度我們確實將長期增長前景從 6% 提高到 8% 到 8% 到 10%。我要說的是，我們確實有額外的產能，這些產能將在 22 財年末和 23 財年在整個企業中上線，我們當然認為這將幫助我們繼續看到 23 財年的強勁表現。我們將無法在量化方面為您提供更多細節，但同樣，繼續將 COVID 需求視為具有多年持續時間。就全球疫苗人口而言，我們仍處於非常早期的階段，我們從增強需求的角度以及更年輕的人群獲得疫苗批准等方面所看到的，繼續讓我們相信這將會將持續多年，包括進入 23 財年。

We have no further questions, and I will now pass over to John for final remark.

我們沒有其他問題了，我現在將請 John 發表最後的評論。

Thanks, operator, and thanks, everyone, for your questions and for taking the time to join our call.

謝謝接線員，也謝謝大家提出問題並抽出時間加入我們的電話會議。

I'd like to close by highlighting a few key points we covered today. We're proud of our performance this quarter and of our skilled and dedicated employees who have allowed us to successfully execute on our long-term growth plans. In fiscal 2022, we now expect stronger revenue and EBITDA growth than our initial guidance, driven by continued growth in our Biologics segment as well as renewed growth in our Softgel and Oral Technologies and Oral and Specialty Delivery segments. Because of the investments we've made over the past few years, which included high-growth franchises like those we have acquired in our Biologics segment, and most recently, with the growth expected as a result of the Bettera acquisition (technical difficulty) millions of patients around the world. We're on track to deliver over 1 billion doses of COVID-19 vaccines as well as millions of COVID therapeutic doses by the end of the calendar year, playing an important role in addressing the COVID-19 pandemic. As we continue to support global efforts to address the pandemic and plan for the future, we remain fully confident (technical difficulty).

最後，我想強調我們今天討論的幾個要點。我們為本季度的業績以及我們技術嫻熟、敬業的員工感到自豪，他們使我們能夠成功執行我們的長期增長計劃。在 2022 財年，我們現在預計收入和 EBITDA 增長將超過我們最初的指導，這得益於我們的生物製品部門的持續增長以及我們的軟膠囊和口服技術以及口服和專業交付部門的新增長。由於我們在過去幾年中進行的投資，其中包括我們在生物製品部門收購的高增長特許經營權，以及最近收購 Betera 後的預期增長（技術難度）數百萬美元世界各地的患者。我們有望在日曆年年底前提供超過 10 億劑 COVID-19 疫苗以及數百萬劑 COVID 治療劑，在應對 COVID-19 大流行方面發揮重要作用。在我們繼續支持全球抗擊疫情和規劃未來的同時，我們仍然充滿信心（技術難度）。