Catalent Inc (CTLT) 2023 Q2 法說會逐字稿

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

大家好，歡迎來到 Catalent, Inc. 2023 財年第二季度收益電話會議。我叫艾米麗，今天我會主持你的電話會議。 （操作員說明）

I will now turn the call over to our host, Paul Surdez, Vice President of Investor Relations. Please go ahead, Paul.

我現在將把電話轉給我們的主持人，投資者關係副總裁 Paul Surdez。請繼續，保羅。

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

大家早上好，感謝大家今天加入我們，回顧 Catalent 的 2023 年第二季度財務業績。今天和我一起參加電話會議的是總裁兼首席執行官 Alessandro Maselli；高級副總裁兼首席財務官 Tom Castellano。

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

請在我們的補充演示文稿的幻燈片 2 上查看我們今天電話會議的議程，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 GAAP and non-GAAP financial measures. It is possible that actual results could differ from management's expectations. We refer you to Slide 3 for more detail on forward-looking statements, slides 4 and 5 discuss Catalent's use of non-GAAP financial measures and our just issued earnings release provides reconciliations to the most directly comparable GAAP measures.

在我們今天的電話會議中，管理層將做出前瞻性陳述，並參考 GAAP 和非 GAAP 財務措施。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 以了解有關前瞻性陳述的更多詳細信息，幻燈片 4 和 5 討論了康泰倫特對非 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。

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

另請參閱 Catalent 的 10-Q 表格，該表格將於今天提交給美國證券交易委員會，以獲取有關可能對我們的經營業績、業績和財務狀況產生影響的風險和不確定性的更多信息。

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

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

Thank you, Paul, and welcome, everyone, to the call. Before turning to our results for the quarter, I want to address the Bloomberg News report that appeared over the weekend, but only to say that, as a matter of policy, we do not comment on market rumors. With that topic out of the way.

謝謝保羅，歡迎大家來接聽電話。在談到我們的季度業績之前，我想談談週末出現的彭博新聞社報導，但只是說，作為一項政策，我們不會對市場傳言發表評論。有了那個話題。

Our second quarter results met our expectations and have strengthened our forward momentum for our strategic plans, highlighted by expanded collaborations with strategic partners, significant new business wins in our drug product and gene therapy offerings, renewed business development in drug substance and exceptional demand for our world-leading Zydis fast-dissolve technology.

我們的第二季度業績符合我們的預期，並加強了我們戰略計劃的前進勢頭，突出表現在與戰略合作夥伴的擴大合作、我們的藥品和基因治療產品的重大新業務勝利、原料藥業務的新發展以及對我們的特殊需求世界領先的 Zydis 快速溶解技術。

As we pass the midway point in fiscal '23, I would like to first look back at the past 6 months. Our non-COVID business continued to show strength, as we grew organic constant currency net revenue above market at approximately 12% despite softness in nutritional supplement demand. We brought online new capacity to support areas of market with anticipated high demand, particularly of prefilled syringes, viral vector manufacturing and the Zydis. We executed our plans to meet the increasing demand for fit-for-scale, high-potent drug manufacturing through the acquisition of Metrics. We are very pleased with its overall performance out of the gate, including the recent FDA approval of 2 new high-potent drug that Metrics is manufacturing.

當我們經過 23 財年的中點時，我想首先回顧一下過去 6 個月。我們的非 COVID 業務繼續表現強勁，儘管營養補充劑需求疲軟，但我們的有機固定貨幣淨收入仍高於市場約 12%。我們帶來了在線新產能，以支持預計會有高需求的市場領域，尤其是預灌封注射器、病毒載體製造和 Zydis。我們執行了我們的計劃，通過收購 Metrics 來滿足對適合規模的高效藥物製造日益增長的需求。我們對其整體表現感到非常滿意，包括最近 FDA 批准 Metrics 正在生產的 2 種新型高效藥物。

Broadening our lens, since the beginning of 2022, Catalent has been a manufacturing partner for a total of 7 new approvals across our -- FDA approvals across our network. In addition, we touched approximately 50% of all FDA approvals through that time through our critical -- clinical supply, analytical support and early development service offerings. We have agreed and announced an extended partnership with the 2 of our largest customers. All of these validates our strategy of providing to our partners a comprehensive portfolio of services underpinned by our operational excellence track record, which together position Catalent to be the partner of choice to maximize the potential of their pipelines and allows us to continue to increase our share of the most valuable molecules in the CDMO market.

擴大我們的視野，自 2022 年初以來，Catalent 一直是製造合作夥伴，在我們的網絡中總共獲得了 7 項新批准—— FDA 批准。此外，我們通過我們的關鍵——臨床供應、分析支持和早期開發服務產品，在這段時間內獲得了大約 50% 的 FDA 批准。我們已經同意並宣布與我們最大的兩家客戶建立長期合作夥伴關係。所有這些都證實了我們的戰略，即以我們卓越的運營記錄為基礎，為我們的合作夥伴提供全面的服務組合，這些共同使 Catalent 成為首選合作夥伴，以最大限度地發揮他們管道的潛力，並使我們能夠繼續增加我們的份額CDMO 市場上最有價值的分子。

Looking forward, I'm very excited to be leading Catalent in the next chapter of our journey. We have a clear mission, to help people live better, healthier lives.

展望未來，我很高興能在我們旅程的下一章中領導康泰倫特。我們有一個明確的使命，即幫助人們過上更好、更健康的生活。

At an investor conference last month, I discussed several aspects of Catalent that should excite everyone about our premier place in the market and the growing opportunities in front of us. Among other things, I noted the continuing growth of our total addressable market, which you can see on Slide 6. Our strategic investments have materially expanded our total addressable market and will provide us with greater future growth opportunities.

在上個月的一次投資者會議上，我討論了 Catalent 的幾個方面，這些方面應該讓每個人都對我們在市場上的領先地位和我們面前不斷增長的機會感到興奮。除其他事項外，我注意到我們總潛在市場的持續增長，您可以在幻燈片 6 中看到。我們的戰略投資極大地擴大了我們的總潛在市場，並將為我們提供更大的未來增長機會。

Since fiscal '17, we have invested over $7 billion to enable accelerated growth in exciting segments of the CDMO market, and those moves have expanded our opportunities. In fiscal '19, we addressed a $35 billion market. After our thoughtful diversification, including investment in technology, capacity and new capabilities, today, we address a $70 billion market as an active and scale player in many of the largest, fastest-growing segments in our space. Looking ahead to fiscal '26, we anticipate our addressable market growing another 40% to $100 billion across the markets in which we operate, and we are incredibly well positioned to continue to increase our share in these markets over time.

自 17 財年以來，我們已投資超過 70 億美元，以加速 CDMO 市場激動人心的領域的增長，這些舉措擴大了我們的機會。在 19 財年，我們解決了 350 億美元的市場。在我們深思熟慮的多元化之後，包括對技術、產能和新能力的投資，今天，我們在我們這個領域的許多最大、增長最快的細分市場中作為一個活躍和規模龐大的參與者解決了一個價值 700 億美元的市場。展望 26 財年，我們預計我們的目標市場在我們運營的市場中將再增長 40% 至 1000 億美元，並且我們處於非常有利的地位，可以隨著時間的推移繼續增加我們在這些市場中的份額。

Now moving on to the highlights of the second quarter. As expected, our second quarter results compared to the prior year period were negatively impacted by the lower year-on-year demand for COVID-related products. However, notably, revenue from COVID products grew sequentially as we were the primary U.S. fill/finish site for our pediatric booster vaccine that received emergency use authorization during our Q2.

現在繼續第二季度的亮點。正如預期的那樣，我們第二季度的業績與去年同期相比受到了 COVID 相關產品需求同比下降的負面影響。然而，值得注意的是，由於我們是我們在第二季度獲得緊急使用授權的兒科加強疫苗在美國的主要填充/完成站點，因此來自 COVID 產品的收入連續增長。

Net revenue of $1.15 billion was down 6% on a reported basis or a 2% decrease on a constant currency basis compared to the second quarter of fiscal '22. When we exclude the impact of acquisition and divestitures, our organic revenue declined 4% measured in constant currency.

與 22 財年第二季度相比，報告的淨收入為 11.5 億美元，下降 6%，按固定匯率計算下降 2%。當我們排除收購和資產剝離的影響時，我們的有機收入以固定匯率計算下降了 4%。

I would like to call out that our organic non-COVID revenue grew approximately 4% in the quarter in constant currency, including double-digits growth in our Biologics segment. This is a slower growth they realized in the first quarter because we prioritized that the launch of the pediatric booster and COVID-related work at our Bloomington facility. We expect consolidated non-COVID revenue growth for the remainder of the fiscal year to be more in line with the Q1 levels, which was more than 20% on a constant currency organic basis, as we address our large backlog of non-COVID work, particularly in our gene therapy and drug product offerings. And our PCH business returns to growth.

我想指出，我們的有機非 COVID 收入在本季度以固定匯率計算增長了約 4%，其中包括我們生物製品部門的兩位數增長。這是他們在第一季度實現的較慢增長，因為我們優先考慮在我們的布盧明頓工廠推出兒科助推器和 COVID 相關工作。我們預計本財年剩餘時間的綜合非 COVID 收入增長將更符合第一季度的水平，在固定貨幣有機基礎上超過 20%，因為我們解決了大量積壓的非 COVID 工作，特別是在我們的基因治療和藥物產品方面。我們的 PCH 業務恢復增長。

Our second quarter adjusted EBITDA of $283 million declined 9% as reported or 6% on a constant currency basis compared to the same quarter of fiscal '22. When excluding M&A, the organic adjusted EBITDA decline was 7% when measured in constant currency.

我們第二季度調整後的 EBITDA 為 2.83 億美元，與 22 財年同期相比下降了 9%，按固定匯率計算下降了 6%。排除併購後，按固定匯率計算，調整後的有機 EBITDA 下降 7%。

Moving to Slide 8. We I would like to cover some data regarding our COVID-related revenue that we addressed during the recent public webcast. Our revenue guidance assumed an approximate $750 million decline in COVID-related revenues from approximately $1.3 billion in COVID revenue we recorded in fiscal '22. We're actually tracking slightly better than previously reported with approximately $450 million in COVID revenue recorded in the first half of the fiscal year and expected additional demand in the fourth quarter to prepare for a seasonal COVID vaccine in the fall, which is expected to result in fiscal '23 COVID revenues that is more than $600 million.

轉到幻燈片 8。我想介紹一些有關我們在最近的公開網絡廣播中處理的 COVID 相關收入的數據。我們的收入指引假設與 COVID 相關的收入比我們在 22 財年記錄的約 13 億美元的 COVID 收入減少了約 7.5 億美元。實際上，我們的追踪情況略好於之前報告的情況，本財年上半年錄得約 4.5 億美元的 COVID 收入，預計第四季度會有額外需求，為秋季的季節性 COVID 疫苗做準備，預計這將導致'23 財政年度 COVID 收入超過 6 億美元。

Having said that, given the expected new seasonality of the product, we expect minimal revenue contribution from COVID products in Q3, resulting in a decline of COVID-related revenue of nearly $350 million when compared to the third quarter of fiscal '22, which was our peak COVID quarter.

話雖如此，鑑於該產品的預期新季節性，我們預計第三季度 COVID 產品的收入貢獻微乎其微，導致與 22 財年第三季度相比，與 COVID 相關的收入下降近 3.5 億美元，這是我們的 COVID 高峰季度。

Moving on, we continue to position ourselves as the industry partner of choice across the pharma, biotech and consumer health sectors. Our position has been further validated by 2 significant strategic partnership expansions.

繼續前進，我們繼續將自己定位為製藥、生物技術和消費者健康領域的首選行業合作夥伴。兩次重要的戰略合作夥伴關係擴展進一步證實了我們的地位。

First, we will be extending and expanding our manufacturing partnership with Moderna, which will see Catalent support the manufacture of multiple Moderna products in multiple formats across our North American and European biologics drug product network. Catalent will continue to provide the drug product fill-finish services and production capacity for Moderna's COVID-19 programs.

首先，我們將擴展和擴大與 Moderna 的製造合作夥伴關係，這將使 Catalent 支持在我們的北美和歐洲生物製劑藥品網絡中以多種形式製造多種 Moderna 產品。 Catalent 將繼續為 Moderna 的 COVID-19項目提供藥品灌裝服務和生產能力。

In addition, there are plans to extend the non-COVID-19 programs such as 2 non-COVID-19 programs such as flu and RSV vaccines from our manufacturing site in Bloomington, Indiana as well extending the partnership to support Moderna from our state-of-the-art European facility in Anagni, Italy. We look forward to our strengthened long-term relationship in helping Moderna advance its robust mRNA pipeline.

此外，我們還計劃從我們位於印第安納州布盧明頓的生產基地擴展非 COVID-19 計劃，例如 2 個非 COVID-19 計劃，例如流感和 RSV 疫苗，並擴大合作夥伴關係以支持來自我們州的 Moderna-位於意大利阿納尼的最先進的歐洲工廠。我們期待著我們加強長期合作關係，幫助 Moderna 推進其強大的 mRNA 管道。

Second, we recently expanded our existing manufacturing partnership with Sarepta. Catalent will be the Sarepta's primary commercial manufacturing partner for its leading gene therapy candidate for the treatment of Duchenne muscular dystrophy, which has May 29 PDUFA date. The agreement was also created mechanisms for Catalent to support multiple gene therapy candidates in the Sarepta pipeline for Limb-girdle muscular dystrophy. To meet increasing demand for maturing gene therapy pipelines from Sarepta and other customers, we are ramping up additional suites at our BWI campus later this year.

其次，我們最近擴大了與 Sarepta 的現有製造合作夥伴關係。 Catalent 將成為 Sarepta 的主要商業製造合作夥伴，用於治療 Duchenne 肌營養不良症的領先基因治療候選藥物，該藥物的 PDUFA 日期為 5 月 29 日。該協議還為 Catalent 創建了機制，以支持 Sarepta 管線中針對肢帶型肌營養不良症的多種基因治療候選藥物。為了滿足 Sarepta 和其他客戶對成熟基因治療管道日益增長的需求，我們將在今年晚些時候在我們的 BWI 園區增加更多套房。

Critical to our business in building strong partnership with our customers is our quality and regulatory track record. Quality and compliance are central to everything we do, and our strong quality management system continues to be a differentiator for Catalent with several strong recent regulatory inspection results.

我們與客戶建立牢固合作夥伴關係的關鍵是我們的質量和監管記錄。質量和合規性是我們所做的一切的核心，我們強大的質量管理體系繼續成為 Catalent 的差異化因素，最近的幾項監管檢查結果非常出色。

In addition to enhancing our strong quality performance, our management team and I have a renewed focus on improving efficiency across the organization and free cash flow generation, as demonstrated by our recently executed restructuring activities. Tom will share additional details on these activities in a moment. He will also walk you through our fiscal '23 guidance ranges, which are unchanged from our November call.

除了提高我們強大的質量績效外，我們的管理團隊和我還重新關注提高整個組織的效率和自由現金流的產生，正如我們最近執行的重組活動所證明的那樣。 Tom 稍後將分享有關這些活動的更多詳細信息。他還將帶您了解我們的 23 財年指導範圍，這些範圍與我們 11 月份的電話會議沒有變化。

On Slide 9, we cover our recent progress in ESG areas. We have a strong commitment to ESG and corporate responsibility at Catalent. And we will soon publish our fiscal '22 corporate responsibility report, which shows our continued progress in this area. We have developed our CR strategy to align to our patient-first culture, enhancing our inclusive culture, which drives our commitment to operational and quality excellence.

在幻燈片 9 中，我們介紹了我們在 ESG 領域的最新進展。在康泰倫特，我們對 ESG 和企業責任有著堅定的承諾。我們將很快發布我們的 22 財年企業責任報告，其中顯示了我們在這一領域的持續進展。我們制定了 CR 戰略，以符合我們患者至上的文化，增強我們的包容性文化，這推動了我們對卓越運營和質量的承諾。

Our CR strategy is focused on 3 main pillars: people, environment and communities, each of which is informed by our employees, communities, customers, investors and other key stakeholders. We put patients and people first, invest in and show respect for our employees and promote responsible supply chain.

我們的 CR 戰略專注於 3 個主要支柱：人、環境和社區，我們的員工、社區、客戶、投資者和其他主要利益相關者都了解我們的每個支柱。我們把病人和人放在第一位，投資並尊重我們的員工，促進負責任的供應鏈。

Recent progress includes completion of a third-party human rights assessment as part of our responsible supply chain initiative, a sizable increase in diversity in our global leadership teams and extensive adoption of our employee resource group at our sites.

最近的進展包括完成第三方人權評估，作為我們負責任的供應鏈計劃的一部分，我們全球領導團隊的多樣性大幅增加，以及在我們的工廠廣泛採用我們的員工資源組。

For the environment, we are heavily focused on reducing our greenhouse gas emissions, waste and water used, as you can see by the targets and initiatives on the slide.

對於環境，我們非常注重減少溫室氣體排放、廢物和水的使用，正如您在幻燈片上的目標和舉措所看到的那樣。

Finally, we give back to our communities by investing our time, talent and resources in serving patients. I'm proud of the increasing contribution that Catalent and employees have made to communities we serve and where we live and work.

最後，我們通過投入時間、人才和資源為患者服務來回饋我們的社區。我為 Catalent 和員工為我們服務的社區以及我們生活和工作的社區做出的越來越多的貢獻感到自豪。

To close, we are uniquely positioned to leverage our cutting-edge technologies to advance health care innovation on behalf of our customers and their patients, while powering the next generation of medicine. We have also created many opportunities for our business through our investment so that we may achieve long-term attractive growth. With the assets we have in place, we are focused on executing our strategy to optimize our best-in-class CDMO ecosystem. We are maximizing asset utilization and free cash flow generation to enhance value for our customers, patients and shareholders.

最後，我們具有獨特的優勢，可以利用我們的尖端技術代表我們的客戶及其患者推進醫療保健創新，同時為下一代醫學提供動力。我們還通過投資為我們的業務創造了許多機會，以便我們可以實現長期有吸引力的增長。憑藉我們擁有的資產，我們專注於執行我們的戰略，以優化我們一流的 CDMO 生態系統。我們正在最大限度地提高資產利用率和產生自由現金流，以提高我們的客戶、患者和股東的價值。

With that, I will turn the call over to Tom.

有了這個，我會把電話轉給湯姆。

Thanks, Alessandro. Before commenting on our segment performance, let me provide you with some additional details related to our recent restructuring activities and other cost savings measures. Our restructuring effort, which was in part driven by our desire to align our organization to our business following the peak surge in COVID-related activity, reduced our cost structure in both operations and at the corporate level and consolidated facilities within our Biologics segment to optimize our infrastructure.

謝謝，亞歷山德羅。在評論我們的部門業績之前，讓我向您提供一些與我們最近的重組活動和其他成本節約措施相關的額外細節。我們的重組工作部分是由於我們希望在與 COVID 相關的活動激增之後使我們的組織與我們的業務保持一致，從而降低了我們在運營和公司層面的成本結構，並整合了我們生物製品部門的設施以優化我們的基礎設施。

Under the restructuring plan, we reduced our headcount by approximately 700 employees and expect to incur cumulative employee charges between $14 million and $20 million. As a result of our restructuring plans, we expect to deliver annualized run rate savings in the range of $75 million to $85 million over calendar 2023, with approximately half of the savings to be realized in the second half of our fiscal '23. In addition, we expect to generate savings from other cost efficiency and procurement programs above and beyond the reduction of approximately 700 staff that are expected to generate additional annualized savings of tens of millions of dollars.

根據重組計劃，我們減少了大約 700 名員工，預計將產生 1400 萬至 2000 萬美元的累計員工費用。由於我們的重組計劃，我們預計在 2023 年日曆年實現 7500 萬至 8500 萬美元的年化運行率節省，其中大約一半的節省將在我們的 23 財年下半年實現。此外，除了裁員約 700 名員工之外，我們還希望通過其他成本效率和採購計劃實現節省，預計每年可額外節省數千萬美元。

Now let's discuss our segment performance where commentary around segment growth will be in constant currency. As shown on Slide 10, Q2 net revenue in our Biologics segment of $580 million decreased 7% compared to the second quarter of 2022. The decline is primarily driven by lower year-on-year COVID-related demand. Q2 results included $54 million from the vaccine take-or-pay settlement disclosed last quarter. The decline in COVID revenue was partially offset by growth across our non-COVID programs, with gene therapy being the strongest growth contributor.

現在讓我們討論我們的細分市場表現，其中圍繞細分市場增長的評論將以不變的貨幣進行。如幻燈片 10 所示，我們生物製品部門第二季度的淨收入為 5.8 億美元，與 2022 年第二季度相比下降了 7%。下降的主要原因是與 COVID 相關的需求同比下降。第二季度業績包括上季度披露的疫苗照付不議結算中的 5400 萬美元。 COVID 收入的下降部分被我們非 COVID 項目的增長所抵消，基因治療是最強勁的增長貢獻者。

Total non-COVID revenue growth for the Biologics segment was more than 10%, down from Q1. The non-COVID revenue growth rate in Biologics is expected to return to the higher levels of growth we saw in the first quarter driven by increased demand in our gene therapy offering, easier comparisons in Brussels and uptake in demand for several drug product programs.

生物製品部門的非 COVID 總收入增長超過 10%，低於第一季度。生物製品的非 COVID 收入增長率預計將恢復到我們在第一季度看到的更高水平的增長，這是由於我們的基因治療產品需求增加、布魯塞爾比較容易以及對幾種藥品項目的需求增加所推動的。

The segment's EBITDA margin of 31.3% was slightly higher than the 31.1% reported in the second quarter of fiscal 2022. Year-over-year margin expansion is mainly attributable to the vaccine take-or-pay settlement that we discussed during our Q1 call.

該部門的 EBITDA 利潤率為 31.3%，略高於 2022 財年第二季度報告的 31.1%。利潤率同比增長主要歸因於我們在第一季度電話會議中討論的疫苗照付不議結算。

As shown on Slide 11, our Pharma and Consumer Health segment generated net revenue of $570 million, an increase of 3% compared to the second quarter of fiscal 2022 with segment EBITDA down 3% over the same period last fiscal year. The segment's revenue growth was primarily driven by the recently acquired Metrics business, which contributed 3 percentage points to the segment's top line and 4 percentage points to the bottom line.

如幻燈片 11 所示，我們的製藥和消費者健康部門產生了 5.7 億美元的淨收入，與 2022 財年第二季度相比增長了 3%，而該部門的 EBITDA 與上一財年同期相比下降了 3%。該部門的收入增長主要是由最近收購的 Metrics 業務推動的，該業務為該部門的收入貢獻了 3 個百分點，為利潤貢獻了 4 個百分點。

There were a number of moving pieces that drove organic PCH results in the quarter. First, as you can see on the revenue stream chart, our Development Services and Clinical Supply Services showed strong growth, but that was offset by a decline in our manufacturing and commercial supply revenue. Within the commercial stream, growth in over-the-counter cold and cough products were offset by a decline in prescription products and lower consumer (inaudible) or spend for nutritional supplements such as gummies and other premium formats.

有許多活動推動了本季度 PCH 的有機業績。首先，正如您在收入流圖上看到的那樣，我們的開發服務和臨床供應服務顯示出強勁的增長，但這被我們的製造和商業供應收入的下降所抵消。在商業流中，非處方感冒和咳嗽產品的增長被處方產品的減少和較低的消費者（聽不清）或軟糖和其他優質形式的營養補充劑的支出所抵消。

The segment's EBITDA margin of 23.7% was lower by roughly 170 basis points year-over-year from the 25.4% recorded in the second quarter of fiscal 2022. Year-over-year margin decline was a result of cost inflation and unfavorable product mix across the network.

該部門的 EBITDA 利潤率為 23.7%，較 2022 財年第二季度的 25.4% 同比下降約 170 個基點。同比利潤率下降的原因是成本膨脹和不利的產品組合網絡。

We expect the PCH segment organic growth rate to modestly increase in the back half of the year, particularly in the fourth quarter, due to continued demand for clinical supply services and increased volume for prescription products, most notably in our Zydis delivery platform.

我們預計 PCH 部門的有機增長率將在今年下半年適度增長，特別是在第四季度，這是由於對臨床供應服務的持續需求和處方產品數量的增加，尤其是在我們的 Zydis 交付平台上。

Moving to consolidated adjusted EBITDA on Slide 12. Our second quarter adjusted EBITDA decreased 9% to $283 million or 24.6% of net revenue. On a constant currency basis, our second quarter adjusted EBITDA declined 6% compared to the second quarter of the prior year.

轉到幻燈片 12 上的合併調整後 EBITDA。我們第二季度調整後的 EBITDA 下降 9% 至 2.83 億美元，占淨收入的 24.6%。按固定匯率計算，我們第二季度調整後的 EBITDA 與去年第二季度相比下降了 6%。

As shown on Slide 13, second quarter adjusted net income was $122 million or $0.67 per diluted share compared to adjusted net income of $163 million or $0.90 per diluted share in the second quarter a year ago.

如幻燈片 13 所示，第二季度調整後淨收入為 1.22 億美元或稀釋後每股收益 0.67 美元，而去年第二季度調整後淨收入為 1.63 億美元或稀釋後每股收益 0.90 美元。

Slide 14 shows our debt-related ratios and other capital allocation priorities. Catalent's net leverage ratio as of December 31, 2022, was 3.7x, up from the 3.2x as of September 30, 2022, due to drawdowns on our revolving credit facility to fund the Metrics acquisition, which closed October 3, 2022.

幻燈片 14 顯示了我們的債務相關比率和其他資本配置優先事項。截至 2022 年 12 月 31 日，Catalent 的淨槓桿率為 3.7 倍，高於截至 2022 年 9 月 30 日的 3.2 倍，原因是我們提取了循環信貸額度以資助於 2022 年 10 月 3 日結束的 Metrics 收購。

Net leverage as of December 31, 2021, was 2.8x, and our long-term net leverage target ratio remains at 3.0x. Our combined balance of cash, cash equivalents and marketable securities as of December 31, 2022, was $470 million, an increase of $125 million from September 30, 2022.

截至 2021 年 12 月 31 日的淨槓桿率為 2.8 倍，我們的長期淨槓桿目標比率仍為 3.0 倍。截至 2022 年 12 月 31 日，我們的現金、現金等價物和有價證券的總餘額為 4.7 億美元，比 2022 年 9 月 30 日增加了 1.25 億美元。

Although our free cash flow generation is improving, there's still work to do, and this remains a significant focus of the management team. For the second quarter, we were pleased to generate free cash flow of approximately $45 million, making the first time in several quarters that we generated positive free cash flow. This was a result of more disciplined CapEx spending, as previously discussed, a strong quarter of AR collections and a rise in contract liabilities due to upfront payments from several customers. We continue to expect our fiscal '23 CapEx as a percentage of revenue to be between 10% and 11%.

儘管我們的自由現金流生成正在改善，但仍有工作要做，這仍然是管理團隊的重要關注點。對於第二季度，我們很高興產生了大約 4500 萬美元的自由現金流，這是幾個季度以來我們首次產生正的自由現金流。如前所述，這是由於更嚴格的資本支出支出、強勁的應收賬款季度以及由於多個客戶的預付款導致的合同負債增加。我們繼續預計我們的 23 財年資本支出佔收入的百分比將在 10% 到 11% 之間。

Free cash flow was again negatively impacted by our strategic decision to maintain increased inventory levels, which we do not expect to change in the short term due to our concerns about the stabilization of the global supply chain and our commitments to our customers to deliver reliable supply. Note that approximately 15% of our inventory includes work in progress, with the remainder being raw materials and supplies. As a reminder, we do not include our customers' finished goods in our inventory balance.

自由現金流再次受到我們保持庫存水平增加的戰略決策的負面影響，由於我們擔心全球供應鏈的穩定以及我們對客戶提供可靠供應的承諾，我們預計短期內不會改變這種情況.請注意，我們庫存的大約 15% 包括在製品，其餘為原材料和供應品。提醒一下，我們的庫存餘額中不包括客戶的成品。

As noted in the past, contract assets are generated as revenue is recorded based on percentage of completion versus entirely on batch release as it is for typical commercial programs.

正如過去所指出的那樣，合同資產的產生是因為收入是根據完成百分比記錄的，而不是像典型的商業項目那樣完全根據批次發布記錄的。

As of December 31, 2022, our contract asset balance was $513 million, a sequential increase of $52 million. This increase was primarily driven by gene therapy programs in the development stage, for which the cash conversion cycle is longer given the duration of the manufacturing and release testing process, which can take multiple quarters from start to finish.

截至 2022 年 12 月 31 日，我們的合同資產餘額為 5.13 億美元，環比增加 5200 萬美元。這一增長主要是由處於開發階段的基因治療項目推動的，考慮到製造和發布測試過程的持續時間，這些項目的現金轉換週期更長，從開始到結束可能需要多個季度。

We have a number of internal initiatives in place to optimize the manufacturing cycle time. In addition, improvement of our contract terms is a potential lever that could reduce our cash conversion cycle and contract asset balance once the batch subject to contract asset treatment is released to the customer and the invoices sent to the customer and the related balance moves from contract assets to accounts receivable.

我們制定了許多內部計劃來優化製造週期時間。此外，我們的合同條款的改進是一個潛在的槓桿，一旦受合同資產處理的批次被釋放給客戶並且發送給客戶的發票和相關餘額從合同中轉移，它可以減少我們的現金轉換週期和合同資產餘額資產為應收賬款。

As you will read in our 10-Q file today, we have 2 strategic customers that collectively represent approximately 35% of our aggregate net trade receivables and current contract asset values in the second quarter. Separately, and unrelated to our balance sheet, during the second quarter, we had 2 customers that each accounted for more than 10% of net revenue. The majority of revenue from these customers were derived from COVID programs.

正如您今天將在我們的 10-Q 文件中讀到的那樣，我們有 2 個戰略客戶，它們共同代表了我們第二季度總淨貿易應收賬款和當前合同資產價值的約 35%。另外，與我們的資產負債表無關，在第二季度，我們有 2 個客戶，每個客戶都占淨收入的 10% 以上。這些客戶的大部分收入來自 COVID 計劃。

Now we turn to our financial outlook for fiscal 2023, as outlined on Slide 15. We are reiterating our guidance ranges for the full year. However, I would like to highlight some of the changes in the assumptions that underpin our projected full year results. First, as mentioned earlier on the call, our COVID business is tracking ahead of our expectations, with full year revenue now expected to be above $600 million compared to our previous estimate of approximately $550 million. Based on current visibility, we expect Q3 to have a minimal COVID contribution and be our lightest COVID quarter by far in fiscal '23. However, looking to Q4, we expect revenue to sequentially increase based on customer demand related to the fall booster season.

現在我們轉向 2023 財年的財務展望，如幻燈片 15 所述。我們重申全年的指導範圍。但是，我想強調一些假設的變化，這些變化是我們預計全年業績的基礎。首先，正如之前在電話會議上提到的，我們的 COVID 業務超出了我們的預期，目前預計全年收入將超過 6 億美元，而我們之前的估計約為 5.5 億美元。根據目前的可見性，我們預計第三季度的 COVID 貢獻最小，並且是我們 23 財年迄今為止最輕的 COVID 季度。然而，展望第四季度，我們預計收入將根據與秋季助推器季節相關的客戶需求而連續增長。

Second, as consumer discretionary spend challenges continue, our projections for consumer health products, including gummies, have been negatively impacted that are now anticipated to be down when compared to prior year levels.

其次，隨著消費者可自由支配支出的挑戰繼續存在，我們對包括軟糖在內的消費者健康產品的預測受到了負面影響，與上一年的水平相比，現在預計會有所下降。

Third, we continue to see increased strength in gene therapy with a significant program further ramping late in our third quarter, which we expect to lead to a notable step-up in Q4 revenue and earnings.

第三，我們繼續看到基因治療的實力在第三季度末進一步增加，我們預計這將導致第四季度收入和收益顯著增加。

Fourth, our non-COVID business outlook remains strong with the second half of the year expected to be in line with the growth we saw in the first quarter, which was more than 20% on an organic constant currency basis. For the full year, non-COVID growth is expected to be in the high teens.

第四，我們的非 COVID 業務前景依然強勁，預計下半年將與我們在第一季度看到的增長保持一致，按有機固定貨幣計算，增長超過 20%。對於全年，非 COVID 增長預計將達到十幾歲。

Fifth. From a quarterly perspective, we expect Q3 revenue to be roughly in line with the reported Q2 results. However, as Q2 included the $54 million take-or-pay agreement, we project margins to be sequentially down from Q2 to Q3, then expanding as we get into the fourth quarter.

第五。從季度的角度來看，我們預計第三季度的收入將與報告的第二季度業績大致一致。然而，由於第二季度包括 5400 萬美元的照付不議協議，我們預計利潤率將從第二季度到第三季度依次下降，然後隨著進入第四季度而擴大。

Finally, the U.S. dollar has weakened since our last report, resulting in a modest FX tailwind when compared to our November assumptions.

最後，自我們上次報告以來美元已經走弱，與我們 11 月份的假設相比，這對外匯產生了溫和的推動作用。

Operator, I would now like to open the call to questions.

接線員，我現在想打開問題電話。

(Operator Instructions) Our first question today comes from Jacob Johnson with Stephens.

（操作員說明）我們今天的第一個問題來自 Jacob Johnson 和 Stephens。

Maybe for Tom, following up on those last comments around the guidance. The updated guidance assumes kind of less of an FX headwind, slightly higher COVID revenue. That would seem to imply maybe you're tempering slightly your organic, ex COVID, growth versus prior expectations. Maybe some of that's related to the 2Q actual. But any areas where you built in some conservatism there?

也許對於湯姆來說，跟進關於指南的最後評論。更新後的指南假設外匯逆風較少，COVID 收入略高。這似乎意味著你可能正在略微緩和你的有機增長，前 COVID，增長與之前的預期。也許其中一些與 2Q 實際有關。但是你在那裡建立了一些保守主義的任何領域？

And then still a fairly wide range for the guidance for this year, just any kind of puts and takes you'd call out as we think about the high and low end of guidance?

然後今年的指導範圍仍然相當廣泛，在我們考慮指導的高端和低端時，你會喊出任何類型的看跌期權嗎？

Sure. Jacob, thanks for the question. Look, I would say we did see, as we mentioned on the call, non-COVID organic growth in the first half of the fiscal year at about 12%. It was down in the second quarter in comparison to where we saw in first quarter levels. However, as we get into the second half of the year, we have line of sight, which is very typical at this point in time to have strong visibility to adjust the remaining 5 or 6 months that we have in the fiscal year from those volumes. So expecting to see non-COVID growth in the second half more in line with what we saw in the first half, again, in that 20% range, and that will bring our full year non-COVID-related growth to be in the mid-teens, as I mentioned on the call.

當然。雅各布，謝謝你的提問。看，我想說我們確實看到，正如我們在電話會議上提到的那樣，本財年上半年的非 COVID 有機增長約為 12%。與我們在第一季度看到的水平相比，第二季度有所下降。然而，當我們進入下半年時，我們有視線，這在這個時間點非常典型，具有很強的可見性，可以根據這些數量調整本財年剩餘的 5 或 6 個月.因此，預計下半年的非 COVID 增長將與我們在上半年看到的情況更加一致，同樣，在 20% 的範圍內，這將使我們的全年非 COVID 相關增長處於中期-正如我在電話中提到的那樣，青少年。

I think we continue to be very bullish on the demand profile we see around gene therapy programs as well as on the drug product side of the business. Those would be the main contributors that we would see to the change in organic non-COVID-related growth in the second half of the year, and we were able to still hold our guidance range and pull back around the assumptions on the PCH side of the business, where, as we mentioned, we continue to see some pressures, particularly when it comes to discretionary spend on the gummies and, I would say, just nutraceutical products across both softgel and gummies in the second half of the year. You did mention FX, that is, I would say, a modest tailwind for us here. But given where we are in the year and only the modest weakening of the dollar we saw in comparison to the euro and GBP, not a significant uplift there.

我認為我們繼續非常看好我們在基因治療計劃以及業務的藥品方面看到的需求概況。這些將是我們將在今年下半年看到的非 COVID 相關有機增長變化的主要貢獻者，我們仍然能夠保持我們的指導範圍並撤回 PCH 方面的假設業務，正如我們提到的，我們繼續看到一些壓力，特別是在軟糖上的可自由支配支出方面，我想說的是，今年下半年軟膠囊和軟糖的保健產品。你確實提到了 FX，也就是說，我想說，這對我們來說是一個適度的順風。但考慮到我們今年的情況，而且與歐元和英鎊相比，我們看到的美元只是溫和走軟，並沒有顯著上漲。

I would say, as you think about the range that we have out there for the full year guide, I think it really comes down to execution in terms of where we land that's in the range. As I said, at this point in time, we typically do have very strong visibility to the demand profile across the business, and it comes down to execution across our network. And we've certainly, I would say, built in some natural hedge just based on the normal execution-related hiccups you can see in this business when you operate 55 sites across the globe.

我想說的是，當你考慮我們全年指南的範圍時，我認為這真的取決於我們在範圍內的著陸點的執行。正如我所說，在這個時間點，我們通常對整個企業的需求概況有非常強的可見性，這歸結為我們整個網絡的執行。我想說的是，我們當然已經建立了一些自然對沖，只是基於當你在全球運營 55 個站點時你可以在這個業務中看到的正常執行相關的小問題。

Got it. That's helpful. And then just my follow-up maybe for Alessandro, just on the agreement with Moderna. First, congratulations, and it's good to see. Can you just talk about this relationship kind of beyond FY '23 as we and investors think about kind of the endemic COVID revenue opportunity, but also the non-COVID work you could do with them perhaps with RSV and flu and COVID? All of these things are kind of blurring together. But just kind of any thoughts about that relationship kind of COVID -- ex COVID dynamics.

知道了。這很有幫助。然後我的後續行動可能是針對亞歷山德羅，只是關於與 Moderna 的協議。首先，恭喜，很高興看到。當我們和投資者考慮某種流行的 COVID 收入機會時，你能否談談這種超越 FY'23 的關係，以及你可以與他們一起做的非 COVID 工作，比如 RSV、流感和 COVID？所有這些事情有點模糊在一起。但是，關於這種 COVID 關係的任何想法——前 COVID 動態。

Sure. Look, first of all, I would say that our relationship with Moderna, it goes back many, many years. So we started to work with them when they were at the very beginning of their journey in 2015, 2016. And so we are very, very pleased how this relationship has grown and continues to grow into the future. I believe that with regards to the vaccine, we are keeping that network to be in the best position to serve what is going to be a seasonal product going forward. So that, on one hand, we can search capacity across our network in multiple sites and at the same time, maintain a level of efficiency and productivity, which is important to us, right? And this is the best way to do it when it comes to seasonal demand.

當然。首先，我想說我們與 Moderna 的關係可以追溯到很多很多年前。因此，當他們在 2015 年、2016 年開始他們的旅程時，我們就開始與他們合作。因此，我們非常非常高興這種關係如何發展並在未來繼續發展。我相信，就疫苗而言，我們正在保持該網絡處於最佳位置，以服務未來將成為季節性產品的產品。因此，一方面，我們可以在多個站點搜索我們網絡中的容量，同時保持一定水平的效率和生產力，這對我們很重要，對吧？當涉及到季節性需求時，這是最好的方法。

On the other hand, very, very excited about participating to these promising new platforms. We continue to support them both on the clinical side, but also preparing across different formats for what the market might require. So we are very excited about this relationship. We've always been in partnership with them, and we are very pleased that this relationship will continue to grow as -- in the next few years.

另一方面，對參與這些有前途的新平台感到非常非常興奮。我們繼續在臨床方面為他們提供支持，同時也為市場可能需要的不同形式做準備。所以我們對這種關係感到非常興奮。我們一直與他們合作，我們很高興這種關係將在未來幾年繼續發展。

Our next question comes from Luke Sergott of Barclays.

我們的下一個問題來自巴克萊銀行的 Luke Sergott。

This is [Salem] on for Luke. Just a couple of questions here. With a couple of quarters left in the fiscal year, what gets you guys to the low to high end of the EBITDA guidance range? Does Sarepta factor in there with their approval? We can just start off there.

這是盧克的[塞勒姆]。這裡只有幾個問題。本財年還剩下幾個季度，是什麼讓你們達到 EBITDA 指導範圍的低端到高端？ Sarepta 是否在他們的批准下考慮在內？我們可以從那裡開始。

Sure. So obviously, we did mention the Sarepta relationship and the PDUFA date being in late May. I would say very little downside risk associated with Sarepta outside of just normal execution here just given the fact that at this point in time, we really do have very strong visibility, as I mentioned earlier, to the volume related to that program and quite frankly, related to many of the larger development and commercial programs that we have across the network.

當然。很明顯，我們確實提到了 Sarepta 關係和 PDUFA 日期是在 5 月下旬。我想說的是，除了這裡的正常執行之外，與 Sarepta 相關的下行風險很小，因為在這個時間點，正如我之前提到的，我們確實非常清楚與該計劃相關的數量，坦率地說，與我們在網絡上擁有的許多大型開發和商業項目相關。

As I said, we continue to manage the business to a higher set of financial targets internally, as we commit to -- that we commit to externally, which is very standard. And as I think about the range of our guidance for next year, I think execution really drives where in that range do we land versus any material changes in demand, just based again on where we are in the fiscal year and the amount of visibility we have around the demand profile across both -- especially across our Biologics business, but I would say even across our Clinical Supply and Pharma side of our PPD or our PCH segment. The one area where I would say we have a little more variability, but again have a relatively reduced outlook related to the consumer health side of our PCH business is certainly already factored into the guidance as well.

正如我所說，我們繼續在內部管理業務以實現更高的財務目標，正如我們承諾的那樣——我們承諾在外部實現，這是非常標準的。當我考慮我們明年的指導範圍時，我認為執行確實推動了我們在該範圍內的位置與需求的任何重大變化，再次基於我們在財政年度的位置和我們的可見度圍繞著兩者的需求概況——尤其是在我們的生物製品業務中，但我想說甚至在我們的 PPD 或我們的 PCH 部門的臨床供應和製藥方面。我想說我們有更多可變性的一個領域，但與我們的 PCH 業務的消費者健康方面相關的前景也相對降低，當然也已經被納入指導。

That's helpful. And then on a follow-up, so the top line guide implies a bit of a step down. What got materially worse? And is that kind of split between PCH and Biologics? And that also implies a 4Q step-up outside of historical norms, is that just from COVID? Any color around that would be helpful.

這很有幫助。然後是後續行動，因此最重要的指南暗示了一些下調。什麼東西變得更糟了？ PCH 和 Biologics 之間是否存在這種分裂？這也意味著第四季度的增長超出了歷史規範，這僅僅是來自 COVID 嗎？周圍的任何顏色都會有所幫助。

Sure. So we did highlight in our prepared remarks that where we do see a change in outlook is primarily driven on the PCH side of the business. And I would say the consumer health part of that business, really the area where we have derisked, I would say, from a COVID standpoint, there certainly is a step-up here in our fourth quarter.

當然。因此，我們確實在準備好的評論中強調，我們確實看到前景發生變化的地方主要是在業務的 PCH 方面。我想說的是，該業務的消費者健康部分，實際上是我們被貶低的領域，我想說，從 COVID 的角度來看，我們第四季度肯定會有所提升。

As we mentioned, we have orders and visibility to a booster season in the fall with demand ramping up across multiple formats for a major strategic customer in that fourth quarter. So given the fact that we do expect to see minimum COVID revenue in our third quarter, based on what we have visibility to, but significant demand in our fourth quarter, we wanted to ensure that, that point was communicated to you all. So again, I would say PCH continues to be the area where we have seen the most pullback and again on the consumer health side of that business.

正如我們所提到的，我們在秋季的助推器季節有訂單和可見性，第四季度主要戰略客戶的多種格式需求增加。因此，鑑於我們確實希望在第三季度看到最低的 COVID 收入，基於我們所了解的情況，但在第四季度有大量需求，我們希望確保這一點已傳達給大家。所以，我要說的是，PCH 仍然是我們看到回調最多的領域，並且再次出現在該業務的消費者健康方面。

Our next question comes from Dave Windley with Jefferies.

我們的下一個問題來自 Jefferies 的 Dave Windley。

So Tom, I wanted to try to focus a little bit on gene therapy and some of your commentary around the contract asset and the conversion of that. So if we presume that Sarepta gets good news and gets approved and you continue there, you say like you'll move the contract asset into build receivable. And then I guess from a commercial product standpoint, it would then become a batch revenue -- a batch delivery revenue recognition model. I guess I'm trying to understand at the point at which that gets approved and you've been recognizing revenue in the contract asset, do you then have a period where there's not revenue recognition until you get the next batch done and deliver that because it's now an approved product? Can you walk us through that a little bit?

所以湯姆，我想試著把重點放在基因治療和你對合同資產及其轉換的一些評論上。因此，如果我們假設 Sarepta 獲得好消息並獲得批准並且你繼續那裡，你會說你會將合同資產轉移到應收賬款中。然後我想從商業產品的角度來看，它會變成批量收入——批量交付收入確認模型。我想我想了解在什麼時候獲得批准並且您一直在合同資產中確認收入，然後您是否有一段時間沒有收入確認，直到您完成下一批並交付它，因為它現在是一個批准的產品？你能給我們介紹一下嗎？

Yes, Dave, it's a great question and one that we continue to wrestle with and work through internally here. I would say there's various different ways that we can address in the event that we do see the Sarepta product essentially moving to commercial. The scenario that you laid out, which would be a movement from percent completion as it's done on the development cycle to batch release upon commercialization, is certainly one of those alternatives. There are other alternatives as well that would align to U.S. GAAP and ASC 606 guidance around revenue recognition, and we are pursuing those and looking at those with our auditor -- in conjunction with our auditor, EY, to ensure that we have the best possible scenario as outlined.

是的，戴夫，這是一個很好的問題，我們將繼續在內部努力解決這個問題。我想說的是，如果我們確實看到 Sarepta 產品基本上轉向商業化，我們可以採用多種不同的方式來解決。您提出的場景，即從開發週期完成的百分比完成到商業化後的批量發布的轉變，當然是其中一種選擇。還有其他替代方案將符合美國公認會計原則和 ASC 606 收入確認指南，我們正在尋求這些並與我們的審計師一起研究這些 - 與我們的審計師安永一起，以確保我們擁有最好的場景概述。

In the situation in which you highlighted, if we were to move to batch release, being driving the recognition and the cycle time remains as long as it is from that production cycle, it would relate -- it would create a period of an air pocket, as you mentioned, from a revenue standpoint. And I think that's the piece that we essentially need to continue to look at.

在您強調的情況下，如果我們要轉向批量發布，推動識別，並且週期時間保持與該生產週期一樣長，那麼它會產生一個氣穴期，正如您提到的，從收入的角度來看。我認為這是我們本質上需要繼續關注的部分。

So as we know more around this and come to determination, one, whether or not that commercial approval is granted in that late May time period, again, being outside of our control, obviously, we'll communicate more to The Street around this. I would say regardless of what happens on May 29, the impact to us in fiscal '23 is minimal, if at all, right, because what we will have at that point in time is the majority of revenue that we would be recognizing in that June time period being batches that are essentially already in flight that have essentially kicked off while the product was still considered a development product.

因此，當我們對此了解更多並做出決定時，第一，無論是否在 5 月下旬的那個時間段內獲得商業批准，顯然，我們都無法控制，我們將就此與華爾街進行更多溝通。我會說，無論 5 月 29 日發生什麼，對我們在 23 財年的影響是微乎其微的，如果有的話，是的，因為我們在那個時間點將擁有的是我們將在那個時候確認的大部分收入6 月時間段是基本上已經在飛行中的批次，這些批次基本上已經開始，而該產品仍被視為開發產品。

So many moving pieces around this, Dave, I think you're asking the right questions. These are the types of things we're looking at internally. And when we come to a determination on exactly what that revenue recognition profile is going to look like for this particular product, given the binary event associated with the approval, we will ensure that that's properly communicated so that you all understand how to model it.

圍繞這個有很多動人的片段，戴夫，我認為你問的是正確的問題。這些是我們正在內部研究的事情類型。當我們確定該特定產品的收入確認概況究竟是什麼樣子時，考慮到與批准相關的二元事件，我們將確保正確傳達這一點，以便你們都了解如何對其進行建模。

I appreciate that. My follow-up question, Alessandro, is for you. You mentioned in your prepared remarks some recent successful regulatory reviews. I was going to ask or give you the opportunity to maybe elaborate on that. Going back a little bit further, you've obviously had some fairly high-profile 483s that probably caused some angst with management and trying to address those and energy and so forth. And so in the context of those things, I guess, I wanted to understand what -- you emphasize Catalent's quality, I wanted to understand, are your aspirations to eliminate these 483s or deal with them best you can when they happen? I'm just wanting to understand where the aspirations are on the track record relative to regulatory review.

我很感激。亞歷山德羅，我的後續問題是給你的。你在準備好的評論中提到了一些最近成功的監管審查。我想請您或給您機會詳細說明這一點。再往前一點，您顯然有一些相當高調的 483，這可能會引起管理層的一些焦慮，並試圖解決這些問題和能源等等。因此，在這些事情的背景下，我想，我想了解什麼——你強調 Catalent 的質量，我想了解，你的願望是消除這些 483 還是在它們發生時盡可能地處理它們？我只是想了解與監管審查相關的往績記錄中的期望。

Sure. Look, this is a great question, and thanks for asking it. So look, first of all, I would say, as you said, 483s are not uncommon in our industry, especially in some type of manufacturing operations, surely sterile operations are the one that the CDs -- to happen more frequently.

當然。看，這是一個很好的問題，謝謝你提出這個問題。因此，首先，我要說的是，正如您所說，483 在我們的行業中並不少見，尤其是在某些類型的製造業務中，無菌操作肯定是 CD 更頻繁發生的操作。

Just to be clear, we don't plan for 483s. We work very hard across our quality management system, with our leadership, with our people, with our operational excellence expectations to avoid this 483 to the extent possible. However, it's -- these are public information. You see that there is a share of those inspections, which will result in 483s. This is true for all the players into the industry. And it's as important as try to prevent them, but even more important, how you respond to those observations in a thorough, extensive and holistic way committing to corrective actions. And some of those corrective actions, actually, most of them yields to an improved operation on the other end of them. So that's one part of the answer.

需要明確的是，我們不打算使用 483。我們在質量管理體系、我們的領導層、我們的員工以及我們的卓越運營期望中非常努力地工作，以盡可能避免這種 483。但是，這是 - 這些是公共信息。您會看到其中有一部分檢查會導致 483。對於所有進入該行業的參與者來說都是如此。這與試圖阻止它們一樣重要，但更重要的是，您如何以徹底、廣泛和全面的方式回應這些觀察結果，並承諾採取糾正措施。其中一些糾正措施，實際上，其中大部分都會在它們的另一端產生改進的操作。所以這是答案的一部分。

The other part of the answer, which I want to stress, is that, as we signaled many times, Catalent receives regular inspections all the time. Now in this couple of cases happen to be, as you said, more visible, but there are inspections all the time. And we are pretty pleased with our track record of inspections, both from share and ratio of the ones resulting in 483s, but also looking at the number of observations that are normal in those 483s.

我想強調的另一部分答案是，正如我們多次發出的信號，Catalent 始終接受定期檢查。現在在這兩個案例中，就像你說的那樣，比較明顯，但是一直都有檢查。我們對我們的檢查記錄非常滿意，無論是從產生 483 的檢查的份額和比例，還是從那些 483 中正常的觀察次數來看。

So look, I know it's been an element of noise in the last few months, but given that the outcome of those inspections you're referring to, plus the ongoing track record on the further inspections we received, we feel pretty confident about our quality management system and our operational excellence.

所以看，我知道這是過去幾個月的噪音因素，但鑑於你所指的那些檢查的結果，加上我們收到的進一步檢查的持續跟踪記錄，我們對我們的質量非常有信心管理系統和我們的卓越運營。

The next question comes from Max Smock of William Blair.

下一個問題來自 William Blair 的 Max Smock。

I just wanted to touch on funding dynamics. I know last quarter, you pointed to some cash conscious decision-making from customers on the biologics side. Just curious if your conversations really have changed here at all given some of the positive developments in the market. And what are customers telling you about their conviction and their ability to go out and raise funds? And how does that compare to when we spoke this time -- at the end of last year?

我只想談談資金動態。我知道上個季度，你指出了客戶在生物製劑方面的一些現金意識決策。只是好奇，考慮到市場的一些積極發展，你們的談話是否真的發生了變化。客戶告訴你什麼關於他們的信念和他們出去籌集資金的能力？這與我們這次談話時相比如何——去年年底？

Yes. Sure. Look, thanks for the question. I believe, look, we need to separate it out in our consideration -- relative considerations and absolute consideration. I will tell you that in absolute terms, our market continue to be a very exciting market. Our share in this market continues to be one of the leading shares into the market. We continue to see very nice wins across the board of our offerings.

是的。當然。看，謝謝你的問題。我相信，看，我們需要在我們的考慮中將其分開——相對考慮和絕對考慮。我會告訴你，從絕對意義上講，我們的市場仍然是一個非常令人興奮的市場。我們在這個市場中的份額仍然是進入市場的主要份額之一。我們繼續看到我們產品的全面成功。

So some of the considerations sometimes are in relative terms, so in terms of what was and what could have been. But in general terms, we are very, very happy about the market that we're operating in. The funding has been surely reducing. But when you look at the growth in our core business, our non-COVID business, you're still seeing the business growing above market and to be honest, in the mid-teens. And when you look at Biologics specifically, even more exciting than that. So I would tell you, the market that did correct a little bit, but still supporting a very exciting growth perspective for the future.

因此，某些考慮因素有時是相對而言的，即過去是什麼以及可能是什麼。但總的來說，我們對我們所在的市場非常非常滿意。資金肯定在減少。但是，當您查看我們的核心業務（我們的非 COVID 業務）的增長時，您仍然會看到該業務的增長高於市場，老實說，在十幾歲左右。當你具體看 Biologics 時，甚至比這更令人興奮。所以我會告訴你，市場確實做了一些調整，但仍然支持未來非常令人興奮的增長前景。

That's good to hear. And then just a quick follow-up for me around the Brussels facility. I know last -- in fiscal year 2022, it was closed down obviously for 6 months. Just wondering if there's anyway or any detail you can provide that helps us think about the margin tailwind in fiscal 2022 from that factory being online for the full year.

聽起來還不錯。然後是我在布魯塞爾工廠周圍的快速跟進。我最後知道——在 2022 財年，它顯然關閉了 6 個月。只是想知道您是否可以提供任何細節或任何細節來幫助我們考慮 2022 財年該工廠全年在線的利潤順風。

Yes. This is -- Brussels is a relatively small facility for us overall, but it's certainly, as I mentioned in my prepared remarks, Matt -- Max, provides a little bit of a tailwind for us here, both from a revenue and a margin standpoint. As you mentioned, the site was taken offline in the second half of the fiscal year. So it is up against a relatively easy comp. But again, Brussels not a significant site in terms of size from a revenue and profitability contribution for the company.

是的。這是 - 布魯塞爾總體上對我們來說是一個相對較小的設施，但它肯定是，正如我在準備好的發言中提到的，馬特 - 麥克斯，從收入和利潤的角度來看，在這里為我們提供了一點順風.正如您提到的，該網站在本財年下半年下線。因此，它與一個相對容易的競爭相對。但同樣，就公司的收入和盈利貢獻而言，布魯塞爾並不是一個重要的站點。

Our next question comes from Paul Knight with KeyBanc.

我們的下一個問題來自 KeyBanc 的 Paul Knight。

On the inventory discussion earlier, are you finding that you can effectively destock now because of better supply chain conditions as well as normalized customer demand?

在之前的庫存討論中，您是否發現由於更好的供應鏈條件以及正常化的客戶需求，您現在可以有效地去庫存？

So I would say, Paul, we're seeing pockets of improvement. And again, we order many different components and inputs for the various different types of products that we manufacture across our Biologics and PCH segments. I would say there are areas of improvement, but there are certainly areas especially on the PCH side of the business, where we do continue to see some challenges from a supply chain standpoint that factored into our decision to continue to remain, I would say, slightly elevated or elevated from an inventory standpoint.

所以我想說，保羅，我們看到了一些改進。同樣，我們為我們在生物製品和 PCH 部門生產的各種不同類型的產品訂購了許多不同的組件和投入。我會說有改進的地方，但肯定有一些領域，尤其是在業務的 PCH 方面，我們確實從供應鏈的角度繼續看到一些挑戰，這些挑戰是我們決定繼續保留的因素，我會說，從庫存的角度來看略有升高或升高。

We were very specific to say that in the short term, this is going to be a tailwind opportunity for us when we have the comfort in being able to pull back on some of those higher levels of inventory, more likely to be a meaningful contributor to free cash flow in '24 than I would say it is in '23. Although as we get into the back half of the year, we should see some modest improvement.

我們非常具體地說，在短期內，這對我們來說將是一個有利的機會，因為我們能夠放心地撤回一些較高水平的庫存，更有可能成為一個有意義的貢獻者24 年的自由現金流比我說的 23 年還要多。儘管進入下半年，我們應該會看到一些適度的改善。

Yes. Look, cutting short the answer, I believe that our level of comfort in destocking is higher in biomanufacturing than it is in small molecule, Given the geographical source of these components, there is a little bit of a difference there.

是的。看，簡而言之，我相信我們在生物製造方面的去庫存舒適度高於小分子，鑑於這些成分的地理來源，那裡存在一點點差異。

And then last question would be, you had mentioned at the beginning, Alessandro, the fill/finish market, very good. And what are the dynamics creating these positive trends in fill/finish? And I believe you're, what, top 1, 2, 3 in the world.

然後最後一個問題是，你在開頭提到過，亞歷山德羅，填充/完成市場非常好。是什麼動力創造了填充/飾面的這些積極趨勢？而且我相信你是世界前 1、2、3 名。

Yes, sure. Look, number one, we are very, very excited about our position in that market being one of the top players. And surely one of the players that before others moved into the state-of-the-art technology, which is fill/finish under (inaudible). So that is really creating a competitive advantage for Catalent and surely continue to increase our share of the most attractive molecules from a CDMO standpoint.

是的，當然。看，第一，我們對我們在該市場中的地位成為頂級參與者之一感到非常非常興奮。並且肯定是在其他人之前進入最先進技術的參與者之一，該技術是在（聽不清）下填充/完成的。因此，這確實為 Catalent 創造了競爭優勢，並且從 CDMO 的角度來看，肯定會繼續增加我們在最具吸引力分子中的份額。

I believe that the positive trends are twofolds. Number one, the pipeline itself is lending naturally towards fill/finish because you're looking at assets in the pipeline, which are -- you cannot put in oral solid, so they are lending themselves more to fill/finish. And because there is a tendency to self administration, they lend themselves more towards pre-filled syringes and (inaudible) injectors. So that's one dynamic. So the pipeline -- when you analyze the pipeline, that's one dynamic.

我相信積極的趨勢是雙重的。第一，管道本身自然地向填充/完成借貸，因為你正在查看管道中的資產——你不能投入口服固體，所以他們更多地借給自己來填充/完成。而且由於存在自我管理的趨勢，他們更傾向於預裝注射器和（聽不清）注射器。所以這是一個動態。所以管道——當你分析管道時，這是一個動態的。

The other one is related to the increased movement of critical products to under isolate technology. Clearly, the regulatory environment is an evolving environment. And so the expectations when it comes to steady assurance, I'm really suggesting that, going forward, the preferred -- by far, the preferred way of doing this is going to be under regulatory. And for that, we are very well positioned with great assets already online and many more coming online in the next 18 months.

另一個與關鍵產品向隔離技術的轉移增加有關。顯然，監管環境是一個不斷變化的環境。因此，關於穩定保證的期望，我真的建議，未來，首選 - 到目前為止，首選的方式將受到監管。為此，我們處於非常有利的位置，大量資產已經上線，並且在未來 18 個月內還會有更多資產上線。

Our next question comes from Tejas Savant with Morgan Stanley.

我們的下一個問題來自摩根士丹利的 Tejas Savant。

Tom, just a quick cleanup on the margin trajectory here into the back half of the year. It sounds like based on your comments, you are expecting a pretty significant sequential step up in EBITDA dollars into the fourth quarter here. Is the right way to think about it, essentially, just the fact that you'll get over $150 million essentially in COVID revenue in the fourth quarter and very little in the third quarter? And ex COVID, can you just point us to sort of how you see that margin line fourth quarter here?

湯姆，只是對今年下半年的利潤率軌跡進行了快速清理。聽起來，根據您的評論，您預計 EBITDA 美元將在第四季度出現相當顯著的連續增長。從本質上講，正確的思考方式是否只是這樣一個事實，即第四季度 COVID 收入將超過 1.5 億美元，而第三季度收入很少？前 COVID，你能告訴我們你如何看待第四季度的利潤線嗎？

Sure. Tejas, I think your point is spot on. Certainly, we will see COVID in that range, as you mentioned. The $150 million-plus after a minimal contribution in Q3, that will certainly drive part of the margin story. But I was also very specific in discussing the ramp-up of the major gene therapy program, as we've talked about being late in the third quarter here and having a full quarter of ramped contribution to us from a fourth quarter standpoint. And given the operating leverage you can see from the utilization of assets there as well as the just normal attractive margins that you see related to the gene therapy side of our business and biologics overall, you can see that step up.

當然。 Tejas，我認為你的觀點是正確的。當然，正如您提到的那樣，我們會在該範圍內看到 COVID。在第三季度做出最小貢獻後的 1.5 億美元以上，這肯定會推動部分利潤率故事。但我在討論主要基因治療計劃的增加時也非常具體，因為我們已經討論過第三季度的延遲，並且從第四季度的角度來看，對我們有整整四分之一的貢獻。考慮到你可以從那裡的資產利用中看到的運營槓桿，以及你看到的與我們業務和生物製品的基因治療方面相關的正常有吸引力的利潤率，你可以看到這一步。

I would say, from a non-COVID standpoint, if you were to strip out COVID out of all of our quarters, you would see a seasonality profile that very closely mirrors what our historical seasonality has been pre-COVID, which is that step-up in -- with the second quarter versus Q1 levels, then a step-up to Q3, but then ultimately a significant ramp in Q4 ahead of the summer months and some of the, I would say, downtime that we see across our customers' networks as well as our own network related to normal maintenance-related activities that you see in the summer months there and taking up sites off-line. So that's certainly all contributing to that significant step-up we see in the fourth quarter.

我想說，從非 COVID 的角度來看，如果你要從我們所有的季度中剔除 COVID，你會看到一個季節性概況，它非常接近地反映了我們在 COVID 之前的歷史季節性，這就是那一步-第二季度與第一季度相比有所上升，然後上升到第三季度，但最終在夏季幾個月之前的第四季度出現顯著增長，我想說的是我們在客戶中看到的一些停機時間網絡以及我們自己的網絡，這些網絡與您在夏季看到的與正常維護相關的活動有關，並且使站點離線。因此，這肯定都有助於我們在第四季度看到的顯著提升。

Got it. That's super helpful. And then one on the -- a two-part on the top line actually perhaps for Alessandro here. So first on Bettera, how confident are you that the asset can return to those sort of 20% growth levels that you talked about at the time of the acquisition? Or do you think of that perhaps as being partially driven by uptake during the pandemic and perhaps now normalizes to a slightly lower level?

知道了。這非常有幫助。然後是 - 頂線的兩部分實際上可能是 Alessandro 在這裡。那麼首先在 Betera 上，您對資產能夠恢復到您在收購時談到的那種 20% 的增長水平有多大信心？或者您是否認為這可能部分是由大流行期間的吸收驅動的，現在可能正常化到略低的水平？

And then the second part of my question here is on the biologics front. As you think about potentially a $400 million to $450 million step down into fiscal '24 from COVID, you'll also be lapping some of these pre-approval sort of like inventory build for Sarepta, et cetera. How do you think about framing the growth for the Biologics segment as it sort of anniversaries those dynamics?

然後我的問題的第二部分是關於生物製品方面的。當您考慮可能從 COVID 進入 24 財年的 4 億美元至 4.5 億美元時，您還將獲得其中一些預先批准，例如 Sarepta 的庫存構建等。您如何看待生物製品領域的增長，因為它有點像那些動態的周年紀念日？

So look, for the Bettera one, this is a market we are looking at very, very closely. Previously, the overall BMS market has decreased, in fact, in 2022. So we are really trying to get together with our customers, with our biggest customers to try and to understand a little more. The fundamental dynamics about this market have not changed, meaning that there is a tendency of people to go to self -- or preventative medicine, so to speak, however you want to call it, and surely gummies is the preferred dosage form.

所以看，對於 Betera 來說，這是一個我們正在非常非常密切地關注的市場。此前，整個 BMS 市場實際上在 2022 年有所下降。所以我們真的在努力與我們的客戶聚在一起，與我們最大的客戶一起嘗試並了解更多。這個市場的基本動態沒有改變，這意味著人們傾向於自我 - 或預防醫學，可以這麼說，無論你怎麼稱呼它，軟糖肯定是首選的劑型。

So the fundamentals are there. Clearly, the market is going through a correction both because of the end market demand, which has contracted in 2022 and because of destocking for cash considerations. So we have seen surely clearly a disappointing trend in the last few quarters. We expect this to continue through our fiscal year. But at the moment, there are signals that at some point in the later part of this calendar year, the correction of inventory could go out. We will be back serving the end market demand.

所以基本面就在那裡。顯然，市場正在經歷調整，這既是因為終端市場需求在 2022 年收縮，也是因為出於現金考慮去庫存。因此，我們在過去幾個季度中肯定清楚地看到了令人失望的趨勢。我們預計這將持續到我們的財政年度。但目前，有跡象表明，在本日曆年下半年的某個時候，庫存修正可能會結束。我們將重新滿足終端市場需求。

With regards of the 2024, it's a little bit too early to have any consideration about it. So as we're going to continue to walk through the fiscal year, we're going to keep you updated about this. But I would say that we continue to be excited about the partnerships we have with the key customers going into the future.

關於 2024 年，現在考慮還為時過早。因此，隨著我們將繼續走過這個財政年度，我們將讓您了解最新情況。但我要說的是，我們對未來與主要客戶的合作夥伴關係感到興奮。

Our next question comes from Sean Dodge of RBC Capital Markets.

我們的下一個問題來自 RBC Capital Markets 的 Sean Dodge。

Tom, you mentioned the $75 million to $85 million of headcount-related savings, but then said there could be some additional beyond that, that could be in the tens of millions of dollars from other efficiency, and I think you said procurement initiatives. Is there any more kind of detail you can share on the time lines for the latter? When do you expect the benefits from the other efficiency and procurement initiatives begin to accrue?

湯姆，你提到了 7500 萬到 8500 萬美元的與員工人數相關的節省，但隨後說可能還有一些額外的，這可能是來自其他效率的數千萬美元，我想你說的是採購計劃。關於後者的時間表，您是否可以分享更多細節？您預計其他效率和採購計劃的好處何時開始累積？

Yes. I think it's the same timing of what we're seeing from a headcount standpoint. The headcount initiatives, we said we were actioning by the end of the calendar year to be able to see the full benefit in the second half of fiscal year and the full annualized savings over the calendar 2023. I would say it's been the same for some of the nonemployee-related initiatives and procurement initiatives that we've had underway. We did highlight the tens of millions, but I would say there will be a partial contribution in fiscal '23 assumed and then the carryover of that being into the first half of fiscal '24. So again, looking at that from the same lens on a calendar year basis.

是的。我認為這與我們從員工人數的角度來看的時間相同。員工人數計劃，我們說我們將在日曆年年底前採取行動，以便能夠在財政年度下半年看到全部收益，並在 2023 日曆年實現全部年度化節省。我想說對一些人來說是一樣的我們正在進行的與員工無關的舉措和採購舉措。我們確實強調了數千萬，但我想說的是，假設 23 財年會有部分貢獻，然後將其結轉到 24 財年的上半年。因此，再次從同一日曆年的角度來看。

Okay. And just to clarify, you said about half of that annual run rate, you expect to capture in the second half of your fiscal '23. It looks like some of these headcount reductions took place after the beginning of Q2. Was there any amount of these savings reflected in this most recent -- your fiscal second quarter?

好的。澄清一下，您說的是年運行率的一半，您希望在 23 財年的下半年獲得。看起來其中一些裁員發生在第二季度開始之後。最近的第二財季是否反映了這些節省的金額？

No, there was no material impact from these initiatives in the second quarter. They were actioned, I would say, late in the second quarter. Some of the cash costs associated with those exits were contemplated in the second quarter. Some of that may perhaps carry into Q3 as well. You'll see that as an add back to our adjusted EBITDA through the restructuring line item. But the real impact from a savings standpoint will be realized in the second half of the fiscal year and then again carry into first half of '24.

不，這些舉措在第二季度沒有產生實質性影響。我想說，他們在第二季度末採取了行動。第二季度考慮了與這些退出相關的一些現金成本。其中一些也可能會帶入第三季度。您會看到這是通過重組項目重新添加到我們調整後的 EBITDA 中。但從儲蓄的角度來看，真正的影響將在本財政年度下半年實現，然後再次進入 24 年上半年。

The next question comes from Justin Bowers of Deutsche Bank.

下一個問題來自德意志銀行的賈斯汀鮑爾斯。

So just based on the comments on PCH as coming in a little lighter, it would imply that biologics is coming in stronger. Can you just help us bridge the non-COVID growth in the second half of the year and some of the key drivers there?

因此，僅基於對 PCH 的評論稍微輕一點，就意味著生物製劑正在變得更強。您能否幫助我們彌合下半年的非 COVID 增長和那裡的一些關鍵驅動因素？

Yes. Justin, we really didn't highlight any material change to the non-COVID biologics growth. I would say it's very similar to what was assumed and what we saw as part of our last guidance. The real change that offsets the call -- the pullback on the PCH side is the overperformance of the COVID portfolio. As we mentioned, COVID was originally assumed to be approximately $550 million of revenue for us in our prior guidance. And based on the orders that we have now related to our fourth quarter as our customer ramps up for the fall booster season, we now expect COVID revenue to be more than $600 million in the year. So it's really the COVID revenue that's offsetting the pullback on PCH.

是的。賈斯汀，我們真的沒有強調非 COVID 生物製劑增長的任何實質性變化。我會說這與假設的以及我們在上次指南中看到的非常相似。抵消電話的真正變化——PCH 方面的回調是 COVID 投資組合的超常表現。正如我們所提到的，在我們之前的指導中，COVID 最初被假設為我們帶來大約 5.5 億美元的收入。根據我們現在與第四季度相關的訂單，因為我們的客戶在秋季助推器季節增加，我們現在預計今年 COVID 收入將超過 6 億美元。因此，真正抵消了 PCH 回調的是 COVID 收入。

Okay. Got it. And then just -- you talked about tech transfers over the last couple of quarters. Have those started? Or are they contributing yet?

好的。知道了。然後 - 你談到了過去幾個季度的技術轉讓。那些開始了嗎？還是他們正在做出貢獻？

And then just with the commentary on the additional suites at Harmans, are they -- when are those coming online? Is that a fiscal year event? Or is that a calendar year event? Just a little more clarity there would be helpful.

然後就哈曼斯的額外套房發表評論，他們是——什麼時候上線？那是財政年度事件嗎？或者這是一個日曆年的事件？只要更清楚一點就會有所幫助。

Yes. Look, let me start from the latter part of your question. So yes, additional suites are coming online as we speak in the -- as we have already shared. The level of utilization is ramping -- will be ramping up in the next few quarters, right? So I believe that in Q3, you're going to see a little bit of a balanced impact because, yes, you're ramping up but you also -- the utilization, but you're also ramping up the costs associated with [diving] and training the people that are required for these new suites. As we said, we remain very optimistic around the gene therapy demand and viral vector manufacturing going forward, not only with Sarepta but across the spectrum of our clients is a pretty good space for us.

是的。看，讓我從你問題的後半部分開始。所以是的，正如我們所說的那樣，其他套件即將上線 - 正如我們已經分享的那樣。利用率水平正在上升——未來幾個季度會上升，對嗎？所以我相信在第三季度，你會看到一些平衡的影響，因為，是的，你在增加，但你也在增加——利用率，但你也在增加與[潛水]相關的成本] 並培訓這些新套件所需的人員。正如我們所說，我們對未來的基因治療需求和病毒載體製造仍然非常樂觀，不僅是 Sarepta，而且我們客戶的整個範圍對我們來說都是一個很好的空間。

With regards to the tech transfer, these tech transfers continue to progress. Of course, there are several programs at the same time progressing. And I would say that the -- we are pleased with the kind of program we're transferring in. And surely, these programs will continue to contribute to attract product growth into the future.

關於技術轉讓，這些技術轉讓繼續取得進展。當然，還有幾個方案同時進行。我要說的是——我們對我們正在轉移的項目類型感到滿意。當然，這些項目將繼續有助於吸引未來的產品增長。

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。

Can we talk a little bit about the Sarepta contract? I'm just sort of curious, is that contemplated and sort of like the ramp-up contemplated in your original fiscal '23 guide? Or is what you're seeing now more incremental to what you had originally expected?

我們能談談 Sarepta 合同嗎？我只是有點好奇，是否考慮過，有點像你最初的 23 財年指南中考慮的增加？或者您現在所看到的是否比您最初預期的更多？

So related to Sarepta, Derik, this is playing out as we had anticipated for the fiscal year here. As I mentioned, the PDUFA date in late May, we're -- depending on where that lands, that doesn't have a material change for us regardless of whether that's an approval or not in the current fiscal year and the outcome of that will have more of an impact for us on fiscal '24. But I would say nothing materially different from what we had assumed based on the -- this has always been a program that obviously our customer, but we have been bullish on as well. So no real change in outlook there in terms of what the '23 impact is related to the announcement here.

與 Sarepta、Derik 相關，這正如我們對本財政年度的預期那樣發揮作用。正如我提到的，5 月下旬的 PDUFA 日期，我們 - 取決於降落的位置，無論在當前財政年度是否獲得批准以及結果如何，這對我們來說都沒有重大變化將對我們在 24 財年產生更大的影響。但我想說的與我們基於的假設沒有什麼實質性的不同——這顯然是我們的客戶一直以來的計劃，但我們也一直看好。因此，就 23 年的影響與此處的公告相關而言，那裡的前景沒有真正的變化。

Yes. I just want to say that the partnership with Sarepta goes -- is a little bit wider than these only programs. So they have some capacity that we dedicate to them into our Harmans facility, and they can allocate different programs, both clinical and preparation for commercial as they see their internal plans developing. So there is more than just CMD here.

是的。我只想說，與 Sarepta 的合作夥伴關係——比這些僅有的項目要廣泛一些。因此，他們有一些能力，我們將這些能力投入到我們的 Harmans 設施中，並且他們可以根據他們看到內部計劃的發展來分配不同的項目，包括臨床和商業準備。所以這裡不僅僅是CMD。

Got it. And I want to follow up on Tejas' question on the PCH business. I mean it does look like that the -- when I look at third-party research on the gummies market, it looks like that's more like a 12%, 13% sort of like growth market from what I've been able to dig up. I mean when you look at that 6% to 10% guide you put out for the long term in the PCH, how critical is the gummy segment going back to the 20% range to sort of like get to that number?

知道了。我想跟進 Tejas 關於 PCH 業務的問題。我的意思是，它確實看起來像——當我查看軟糖市場的第三方研究時，它看起來更像是一個 12%、13% 的增長市場，從我能夠挖掘的市場來看.我的意思是，當您查看 PCH 中長期發布的 6% 至 10% 指南時，軟糖部分回到 20% 範圍以達到該數字有多重要？

So look, number one, I would tell you that we never assume a business going forward to grow at the top end of any range. So we didn't assume in our story there the 20% assumption for sure, right? So we tend to be pretty conservative on this forecast because, as you know, things may change in these markets. So that's the first consideration.

所以看，第一，我會告訴你，我們從不假設一個企業在任何範圍的頂端增長。所以我們並沒有在我們的故事中假設 20% 的假設是肯定的，對吧？因此，我們對這一預測往往非常保守，因為如您所知，這些市場的情況可能會發生變化。所以這是首先要考慮的。

The second consideration I would tell you in terms of the PCH story, there is much more to PCH just regarding the gummies. When you look at the demand we are seeing, that was in my remarks around Zydis dosage form, it's just extensional demand. And I used the word exceptional not by chance or mistake. We are seeing the demand that is far exceeding capacity. So we are building capacity as fast as we can. We're going to be opening soon in North America -- not very soon, but sometimes in the next few quarters our North America facility for Zydis because we need an additional facility.

第二個考慮因素我會告訴你關於 PCH 的故事，PCH 只是關於軟糖的更多內容。當你看到我們看到的需求時，在我對 Zydis 劑型的評論中，這只是擴展需求。我使用例外這個詞不是偶然或錯誤的。我們看到的需求遠遠超過了產能。因此，我們正在盡可能快地建設能力。我們將很快在北美開設工廠——不是很快，但有時會在接下來的幾個季度內開設 Zydis 的北美工廠，因為我們需要一個額外的工廠。

We have installed recently -- last year, we have installed an additional line in Zydis, we are working on a number of operational excellence programs to debottleneck capacity there. But there are some very, very visible products, which are growing very fast in the Zydis format. So that is one area that is surely contributing to the growth story of PCH. And let me remind you that's one of the most profitable business of the current network. It should be over and above some other businesses, even considering biologics.

我們最近安裝了——去年，我們在 Zydis 中安裝了一條額外的生產線，我們正在開展一些卓越運營計劃，以消除那裡的產能瓶頸。但是有一些非常非常明顯的產品，它們在 Zydis 格式中增長非常快。因此，這肯定是對 PCH 增長故事做出貢獻的一個領域。讓我提醒您，這是當前網絡中最賺錢的業務之一。它應該超越其他一些業務，甚至考慮生物製劑。

And with regards to the other parts of PCH, look, clearly, PCH, especially in the pharmaceutical supply, is very much dependent on the timing of some approvals and the timing of some of -- and the launch of some of these approvals. So it tends to be a little bit lumpy at times. But when you look at in the 3 to 5 years horizon, that is a business that is a very exciting pipeline to support growth.

至於 PCH 的其他部分，很明顯，PCH，尤其是在藥品供應方面，在很大程度上取決於一些批准的時間和一些批准的時間——以及其中一些批准的啟動。所以它有時會有點凹凸不平。但是當你在 3 到 5 年的範圍內看時，這是一個非常令人興奮的支持增長的管道。

Our next question comes from John Sourbeer of UBS.

我們的下一個問題來自瑞銀的 John Sourbeer。

Just with the increase in the COVID guidance in that greater than $600 million in strength in 4Q, any one you could provide some color on what the endemic COVID run rate looks here even beyond fiscal '23? And what should we -- how should we think about this long term?

隨著 COVID 指南在第四季度增加超過 6 億美元的實力，任何人都可以提供一些顏色，說明這裡的流行 COVID 運行率甚至超過 23 財年？我們應該——我們應該如何考慮這個長期目標？

Well, I think it's a difficult question to answer, John. So we're going to hold back from giving any more specifics around what fiscal '24 could look like here. But I think the relationship and the continued relationship and strategic partnership that's been extended as well as expanded with Moderna, I think, speaks to the future that we believe exists for COVID- and vaccine-related revenue in the future for us. But again, we're going to fall short of giving any specific run rate as we exit this year in terms of what that could look like for us in '24.

嗯，我認為這是一個很難回答的問題，約翰。因此，我們將不再提供有關 24 財年在這裡可能是什麼樣子的更多細節。但我認為，與 Moderna 的關係以及持續的關係和戰略夥伴關係已經擴展和擴展，我認為，這說明了我們相信未來 COVID 和疫苗相關收入存在的未來。但同樣，在我們今年退出時，我們將無法根據 24 年的情況給出任何具體的運行率。

I'm going to add one comment to this one. Look, the fact that we are bringing online more assets into the network surely will contribute to the ability of running an endemic business with better productivity and profitability.

我要對此添加一條評論。看，我們正在將更多在線資產帶入網絡這一事實肯定會有助於以更高的生產力和盈利能力運行地方性業務。

If I could add, sneak in a follow-up. The company has previously said, I think, working on greater than 150 gene -- supported gene therapy products. Any update just on the number of programs here and just how we think about with the additional capacity coming online in that non-Sarepta opportunity with some of these programs?

如果我可以補充，偷偷跟進。我認為，該公司此前曾表示，正在研究超過 150 種基因支持的基因治療產品。關於這裡的程序數量的任何更新，以及我們如何考慮在非 Sarepta 機會中使用其中一些程序的額外容量上線？

Yes. I wouldn't say there's any change to that. We continue to work on about 150 development programs across that part of the business. That's what has justified further capacity expansions within that space. And I would say not only we're pleased with the number of programs we work on, on the gene therapy side of the business but also the progression and maturity of those that continue to move from earlier phase to a later phase. And obviously, the Sarepta relationship and program or programs is just one example of that. So again, feel very good about the growth prospects and opportunities in this business.

是的。我不會說這有任何改變。我們繼續在這部分業務中開展大約 150 個開發項目。這就是在該空間內進一步擴展容量的理由。我要說的是，我們不僅對我們在業務的基因治療方面開展的項目數量感到滿意，而且對那些繼續從早期階段轉向後期階段的項目的進展和成熟度感到滿意。顯然，Sarepta 關係和一個或多個項目只是其中的一個例子。因此，再次對這項業務的增長前景和機會感到非常滿意。

Our next question comes from Evan Stover with Baird.

我們的下一個問題來自 Baird 的 Evan Stover。

Just one for me because John asked one of mine, but this is a cleanup. Last quarter, you said you had some efficiency initiatives that were in flight and in your last updated guidance. So I just wanted to be perfectly clear that $75 million to $85 million of efficiency actions that you kind of noted today. Is that prior program? Or is that incremental addition -- an additional cost savings to your guide today?

只給我一個，因為約翰問了我一個，但這是一個清理。上個季度，你說你有一些正在進行中的效率計劃，並且在你最近更新的指南中。所以我只想非常清楚，您今天提到的 7500 萬到 8500 萬美元的效率行動。是之前的程序嗎？或者是增量添加 - 為您今天的指南節省額外的成本？

No. Evan, these were all originally contemplated. We felt the need to be able to provide some additional disclosure and meat on the bone, if you will, related to the cost savings initiatives. The 700 headcounts we've talked about were difficult for us to talk through at the time of our last guidance because we weren't able -- we didn't execute on those, but now we've since executed on that through the end of the calendar year. So we'll see half of that run rate savings in the current fiscal year with the remaining half to be carried into the first half. So you should look at that annualized number across calendar '23 versus our fiscal year. And I would say the further commentary around the tens of millions of dollars related to other cost savings initiatives, efficiencies and procurement programs were also contemplated as part of the original guide.

不，埃文，這些都是最初設想的。如果您願意，我們認為有必要提供一些與成本節約計劃相關的額外披露和內容。我們談到的 700 名員工人數在我們上次指導時很難討論，因為我們不能——我們沒有執行這些，但現在我們已經執行到最後日曆年。因此，我們將在本財政年度看到一半的運行率節省，剩下的一半將結轉到上半年。所以你應該看看日曆'23 與我們財政年度的年化數字。我想說的是，關於與其他成本節約舉措、效率和採購計劃相關的數千萬美元的進一步評論也被視為原始指南的一部分。

Our final question comes from Jack Meehan of Nephron Research.

我們的最後一個問題來自 Nephron Research 的 Jack Meehan。

So I want to talk about core organic growth. It was over 20% last quarter. It was 4% this quarter. Can you frame for us the math on some of the moving parts that led to the quarterly slowdown? And then for 3Q, is the reacceleration over 20% happening right now? Just talk about your visibility at the end of that.

所以我想談談核心有機增長。上個季度超過 20%。本季度為 4%。您能否為我們構建導致季度放緩的一些移動部件的數學模型？然後對於 3Q，現在是否正在發生超過 20% 的再加速？最後談談你的知名度。

Sure. So Jack, I think we've said in Alessandro's comments that one of the things we needed to do was prioritize a COVID-related program related to the emergency use authorization of the pediatric COVID vaccine over non-COVID-related revenue out of our Bloomington facility. I'm not going to be in a position to tell you what our non-COVID growth would have been in the second quarter if we weren't prioritizing that program, but that certainly had a significant impact and why we were only able to achieve 4% non-COVID growth in Q2 and 12% non-COVID growth in Q2 for the Biologics business. But it's not necessarily the same assets and lines that are being utilized, but it's certainly the same operations and quality folks that we have in terms of putting in the time and efforts around releasing of batches. So that certainly played into why we had a depressed non-COVID-related growth in the second quarter.

當然。所以傑克，我想我們在亞歷山德羅的評論中說過，我們需要做的一件事是優先考慮與兒科 COVID 疫苗的緊急使用授權相關的 COVID 相關計劃，而不是我們布盧明頓的非 COVID 相關收入設施。如果我們不優先考慮該計劃，我無法告訴您我們第二季度的非 COVID 增長情況，但這肯定會產生重大影響，以及為什麼我們只能實現生物製品業務第二季度非 COVID 增長 4%，非 COVID 增長 12%。但這不一定是正在使用的相同資產和生產線，但它肯定是我們在發布批次方面投入時間和精力方面擁有的相同運營和質量人員。因此，這肯定是我們第二季度非 COVID 相關增長低迷的原因。

So I think returning in the third quarter back to non-COVID levels that we have seen through the first quarter of the year is what I would consider to be normal course or a low bar based on what we've been able to show. And again, the uptick in COVID-related revenue that we expect to see in the fourth quarter is really offsetting the pullback on the PCH side of the business, where we continue to experience headwinds, particularly in consumer health.

因此，我認為在第三季度回到我們在今年第一季度看到的非 COVID 水平，我認為這是正常過程，或者根據我們能夠展示的情況，這是一個低標準。再一次，我們預計在第四季度看到的與 COVID 相關的收入的增長確實抵消了 PCH 業務方面的回調，我們在這方面繼續遇到不利因素，尤其是在消費者健康方面。

Got it. And I wanted to try on the margin one more time. Just looking at the fourth quarter, your guidance in the commentary, I think it implies 4Q EBITDA is about 40% of the full year. I look over the last 5 years, it's about 33%. So just help us with the math. Again, I know there are some things that are really stepping up in the fourth quarter. It's just much more pronounced than I think we've seen previously?

知道了。我想再試一次邊緣。看看第四季度，你在評論中的指導，我認為這意味著第四季度 EBITDA 約為全年的 40%。我回顧過去 5 年，大約是 33%。因此，只需幫助我們進行數學運算即可。同樣，我知道在第四季度確實有一些事情在加強。它只是比我認為我們以前看到的要明顯得多？

Yes. I think your numbers are probably close. Maybe I'd say it's a little bit on the high side in terms of the Q4 contribution, but again, not materially different, I would say. Three things I'd point to. One, the COVID-related revenue here is going to be sizable, as we've already talked about. The ramp-up on the gene therapy side of the business related to a major customer program that we've talked about here. New capacity that's going to be coming online in the third quarter, it's going to be utilized. This is going to be by far the strongest gene therapy contribution we've ever seen in the fourth quarter.

是的。我想你的數字可能很接近。就第四季度的貢獻而言，也許我會說它有點偏高，但我想說的是，沒有實質性的不同。我要指出三件事。第一，正如我們已經討論過的，這裡與 COVID 相關的收入將會相當可觀。業務基因治療方面的增長與我們在這裡討論的一個主要客戶計劃有關。將在第三季度上線的新產能將得到利用。這將是迄今為止我們在第四季度看到的最強勁的基因治療貢獻。

So very difficult to compare that to historical years where we weren't seeing gene therapy contributions to the levels that we'll see here around the business. But these are (inaudible) area that I would say -- I would factor in. And then just a normal level of seasonality that we see around the PCH side of the business around Q4, heading into the summer shutdown period is another item to take into consideration here.

很難將其與我們沒有看到基因治療對我們將在業務中看到的水平的貢獻的歷史年份進行比較。但這些是我要說的（聽不清）區域 - 我會考慮在內。然後我們在第四季度左右看到業務的 PCH 方面的正常季節性水平，進入夏季停工期是另一個要考慮的問題在這裡考慮。

Lastly, I would say the Brussels dynamic for us in the prior year, if you're looking at this, then certainly, I would say, a headwind that we had in the prior year. So the natural lift up that we'll see here for the fourth quarter, that was a business that was shut down or a facility that was shut down for us, that will be up and running here as well. So I think all of those things factor into the margin profile we expect to see in the fourth quarter.

最後，我想說一下布魯塞爾在前一年對我們的影響，如果你正在看這個，那麼我肯定會說，我們在前一年遇到了逆風。因此，我們將在第四季度在這裡看到的自然提升是一家被關閉的企業或一家為我們關閉的設施，它們也將在這裡啟動並運行。所以我認為所有這些因素都會影響我們預計在第四季度看到的利潤率。

And lastly, I would say, I'd just reiterate that this was -- that the demand is there, right? The level of visibility that we have to volume here or demand for the second half of the year and even the fourth quarter is high, and it comes down to the levels of execution that we're able to deliver upon across our network of sites.

最後，我想說，我只是重申這是——需求存在，對嗎？我們必須在這里處理的可見性水平或今年下半年甚至第四季度的需求都很高，這歸結為我們能夠在我們的網站網絡上交付的執行水平。

Those are all the questions we have for today. So I'll turn the call back to Alessandro for concluding remarks.

這些就是我們今天的所有問題。所以我會把電話轉回給亞歷山德羅，讓他發表總結性意見。

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

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

Thank you.

謝謝。

Thank you, everyone, for joining us today. This concludes our call, and you may now disconnect your lines.

謝謝大家今天加入我們。我們的通話到此結束，您現在可以斷開您的線路。