Stevanato Group SpA (STVN) 2023 Q1 法說會逐字稿

Good afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Stevanato Group's First Quarter 2023 Financial Results Conference Call. (Operator Instructions)

下午好。這是 Chorus Call 會議接線員。歡迎並感謝您參加斯蒂瓦那托集團 2023 年第一季度財務業績電話會議。 （操作員說明）

At this time, I would like to turn the conference over to Ms. Lisa Miles, Senior Vice President, Investor Relations. Please go ahead, madam.

此時，我想將會議轉交給投資者關係高級副總裁 Lisa Miles 女士。請繼續，女士。

Good morning, and thank you for joining us. With me today is Franco Stevanato, Executive Chairman; Franco Moro, Chief Executive Officer; and Marco Dal Lago, Chief Financial Officer. A presentation illustrating today's results can be found on the IR section of our website. As a reminder, some statements being made today will be forward-looking in nature and are only predictions. Actual events and results may differ materially as a result of risks we face including those discussed in Item 3D entitled Risk Factors in the company's most recent annual report on Form 20-F filed with the Securities and Exchange Commission. We encourage you to review the information contained in our earnings release in conjunction with our SEC filings and our latest Form 20-F. The company does not assume any obligation to revise or update these forward-looking statements to reflect subsequent events or circumstances, except as required by law.

早上好，感謝您加入我們。今天和我在一起的是執行主席 Franco Stevanato； Franco Moro，首席執行官；和首席財務官 Marco Dal Lago。在我們網站的 IR 部分可以找到說明今天結果的演示文稿。提醒一下，今天發表的一些聲明本質上是前瞻性的，只是預測。由於我們面臨的風險，包括公司向美國證券交易委員會提交的最新 20-F 表年度報告中標題為風險因素的第 3D 項中討論的風險，實際事件和結果可能存在重大差異。我們鼓勵您結合我們向美國證券交易委員會提交的文件和我們最新的 20-F 表格，查看我們的收益發布中包含的信息。除非法律要求，否則公司不承擔任何修改或更新這些前瞻性陳述以反映後續事件或情況的義務。

Today's presentation may contain non-GAAP financial information. Management uses this information in its internal analysis of results and believes this information may be informative to investors in gauging the quality of our financial performance, identifying trends in our results and providing meaningful period-to-period comparisons. For a reconciliation of the non-GAAP measures, please see the company's most recent earnings press release.

今天的演示文稿可能包含非 GAAP 財務信息。管理層在其內部結果分析中使用此信息，並認為此信息可能為投資者提供信息，以衡量我們的財務業績質量，確定我們的結果趨勢並提供有意義的期間比較。有關非 GAAP 措施的調節，請參閱公司最近的收益新聞稿。

And with that, I'll hand the call over to Franco Stevanato for opening remarks.

有了這個，我將把電話交給 Franco Stevanato 做開場白。

Thank you, Lisa, and thanks for joining us today. Our solid first quarter results confirm the positive momentum exiting 2022. They illustrate the strength in the fundamentals of our business. As we advance our multi-year strategic plan to capitalize on rising demand and to drive durable growth. Our experience in delivering high-quality, high-performing products makes us a partner of choice with customers. Our long history of embedding science, technology and industry expertise to drive continuous advancements has led to highly differentiated product portfolio. We work alongside our customers to drive innovation by supporting them in the early-stage development through the entire life cycle of the drug.

謝謝你，麗莎，感謝你今天加入我們。我們穩健的第一季度業績證實了 2022 年的積極勢頭。它們說明了我們業務基本面的實力。隨著我們推進多年戰略計劃，以利用不斷增長的需求並推動持久增長。我們在提供高質量、高性能產品方面的經驗使我們成為客戶的首選合作夥伴。我們利用科學、技術和行業專業知識推動持續進步的悠久歷史造就了高度差異化的產品組合。我們與客戶合作，通過在藥物的整個生命週期中支持他們的早期開發來推動創新。

Our mission-critical products are built into the regulatory filings, creating a captive customer base. We operate in growing end markets with strong secular tailwinds. We have an increasing presence in biologics which is the fastest-growing market segment. We see ample opportunities in treatment classes such as GLP1s, monoclonal antibodies, mRNA applications and biosimilars over the next several years.

我們的關鍵任務產品已納入監管文件，從而建立了專屬客戶群。我們在長期順風的不斷增長的終端市場開展業務。我們在增長最快的細分市場生物製品領域的影響力越來越大。未來幾年，我們在 GLP1、單克隆抗體、mRNA 應用和生物仿製藥等治療類別中看到了大量機會。

Our presence in GLP1s dates back to 2010. We believe that we are well positioned to further support customers in the coming ways of new indication for GLP1s. While this presents a significant opportunity for us, it is just one of the many favorable tailwinds within the growing biologics market.

我們在 GLP1 領域的存在可追溯到 2010 年。我們相信，我們有能力在未來的 GLP1 新適應症方面進一步支持客戶。雖然這對我們來說是一個重要的機會，但它只是不斷增長的生物製品市場中眾多有利因素之一。

Above all, our global footprint, differentiated product portfolio and integrated end-to-end solutions offer customers a unique value proposition. This provides us with sustained competitive advantages. We believe we are ideally poised to seize the opportunities in front of us to drive long-term organic growth and build shareholder value.

最重要的是，我們的全球足跡、差異化的產品組合和集成的端到端解決方案為客戶提供了獨特的價值主張。這為我們提供了持續的競爭優勢。我們相信，我們已做好充分準備，抓住眼前的機遇，推動長期有機增長並創造股東價值。

I will now hand the call over to Franco.

我現在將把電話交給 Franco。

Thank you, Franco. Starting on Slide 7. We are off to a good start with the first quarter results, highlighted by 12% revenue growth and an adjusted EBITDA margin of 26%. Strong demand for our EZ-fill products has driven the shift in revenue towards more accretive high-value solutions which represented approximately 32% of revenue in the first quarter.

謝謝你，佛朗哥。從幻燈片 7 開始。第一季度業績開局良好，收入增長 12%，調整後 EBITDA 利潤率為 26%。對我們的 EZ-fill 產品的強勁需求推動了收入轉向更具增值性的高價值解決方案，該解決方案佔第一季度收入的約 32%。

For the first quarter, new order intake decreased to approximately EUR 236 million compared to last year. This was due to the expected drop in COVID-19 orders and the normalization of customer ordering patterns as global supply chain stabilize. At the end of the first quarter, our backlog of committed orders totaled approximately EUR 955 million.

與去年同期相比，第一季度新訂單減少至約 2.36 億歐元。這是由於 COVID-19 訂單的預期下降以及隨著全球供應鏈穩定客戶訂購模式的正常化。截至第一季度末，我們積壓的承諾訂單總額約為 9.55 億歐元。

Turning to Page 8. During the quarter, we announced an agreement with Thermo Fisher to launch a fully integrated supply chain for our proprietary on-body delivery system. The collaboration leverages the power of our integrated capabilities by bringing together our on-body drug delivery device are ready to use EZ-fill cartridges in our assembly lines, while Thermo Fisher will provide fill and finish and final assembly services. The collaboration offers pharma customers have proven end-to-end supply chain to support clients from drug development to commercialization. We also signed an agreement to develop and manufacture Alba pre-fillable syringes for Recipharm's soft mist inhaler.

翻到第 8 頁。本季度，我們宣布與 Thermo Fisher 達成協議，為我們專有的人體輸送系統推出完全集成的供應鏈。此次合作利用了我們整合能力的力量，將我們的身體給藥裝置整合在一起，準備在我們的裝配線上使用 EZ-fill 藥筒，而 Thermo Fisher 將提供灌裝和完成以及最終組裝服務。該合作為製藥客戶提供了經過驗證的端到端供應鏈，以支持客戶從藥物開發到商業化。我們還簽署了一項協議，為 Recipharm 的軟霧吸入器開發和製造 Alba 預填充注射器。

The combination of our Alba syringes and Recipharm's innovative technology delivers sensitive biologics more efficiently and provides enhanced stability and safety. Our Alba platform is purpose-built for biologics because it significantly reduces any potential interaction between the drug and the container.

我們的 Alba 注射器與 Recipharm 的創新技術相結合，可以更有效地提供敏感的生物製劑，並提供更高的穩定性和安全性。我們的 Alba 平台專為生物製品而設計，因為它顯著減少了藥物與容器之間的任何潛在相互作用。

On Page 9, the self-administration of medicine and pharmaceutical innovation are creating demand for our products. Consequently, we expect that continued advancements in biologics, including mRNA applications, monoclonal antibodies, the newest class of GLP1s and biosimilars will drive durable organic growth over the long term. While GLP1s has been an established treatment for diabetes for many years, they are demonstrating remarkable results in weight management. This is driving significant demand for obesity treatment. Diabetes and obesity affect a significant portion of the world's population and the rates of incidents are expected to climb.

在第 9 頁，醫學的自我管理和藥物創新正在創造對我們產品的需求。因此，我們預計生物製劑的持續進步，包括 mRNA 應用、單克隆抗體、最新一類 GLP1 和生物仿製藥，將推動長期持久的有機增長。雖然 GLP1s 多年來一直是糖尿病的既定治療方法，但它們在體重管理方面顯示出顯著的效果。這推動了對肥胖治療的巨大需求。糖尿病和肥胖症影響著世界上很大一部分人口，預計發生率會上升。

According to the World Obesity Federation, an estimated 38% of the population was considered overweight or obese in 2020. This is projected to rise to 51% by 2035, if current trends prevail.

根據世界肥胖聯合會的數據，到 2020 年，估計有 38% 的人口被認為超重或肥胖。如果目前的趨勢持續下去，預計到 2035 年這一比例將上升到 51%。

Moving to Page 10. Today, the majority of injectable treatments for these diseases use either a pen device or auto-injector for self administration. In the case of a pen device, the doses can be modulated and the device can be used more than once. The pen uses a glass pen cartridge, and it is the standard delivery format adopted globally for diabetes care. For single-use auto-injectors, the standard format is a syringe. As the market leader in pen cartridges, we have built a leading franchise supporting diabetes management. Our established role in the diabetes market helped anchor our position as one of the primary suppliers in the GLP1 market for obesity treatment.

轉到第 10 頁。今天，大多數針對這些疾病的注射治療使用筆式裝置或自動注射器進行自我給藥。在筆式裝置的情況下，可以調節劑量並且可以多次使用該裝置。該筆使用玻璃筆芯，是全球糖尿病護理採用的標準交付方式。對於一次性自動注射器，標準形式是注射器。作為筆芯的市場領導者，我們建立了支持糖尿病管理的領先特許經營權。我們在糖尿病市場的既定角色有助於鞏固我們作為 GLP1 肥胖治療市場主要供應商之一的地位。

In fact, we are present in both commercialized GLP1 products and new programs under development, including biosimilars. The range of products we supply today includes bulk cartridges, EZ-fill cartridges and high-value syringes. On the engineering side, we are also supplying lines for vision inspection and lines for assembly and packaging. We expect that the GLP1s will continue to contribute to growth in the coming years. Most importantly, our opportunity set is not limited to any single class of treatment. As Franco mentioned, we see broad opportunities across biologics which is driving demand for high-value solutions.

事實上，我們參與了商業化的 GLP1 產品和正在開發的新項目，包括生物仿製藥。我們今天提供的產品範圍包括散裝藥筒、EZ-fill 藥筒和高價值注射器。在工程方面，我們還提供視覺檢測線以及組裝和包裝線。我們預計 GLP1 將在未來幾年繼續為增長做出貢獻。最重要的是，我們的機會集不限於任何單一類別的治療。正如 Franco 提到的，我們看到了生物製品領域的廣泛機遇，這推動了對高價值解決方案的需求。

On Page 11, a brief update on our capital projects. In both the U.S. and Italy, progress is advancing largely as expected. As we mentioned last quarter, we accelerated our expansion plans in Indiana in response to higher demand for high-value solutions, driven principally by the growth in biologics. The first production lines are on site. We are actually bringing on staff and validation activities are still expected to begin in the fourth quarter. In Latina, Italy, validation is still expected to begin this summer followed by commercial production in the fourth quarter.

第 11 頁簡要介紹了我們的資本項目。在美國和意大利，進展基本符合預期。正如我們在上個季度提到的，我們加快了在印第安納州的擴張計劃，以響應對高價值解決方案的更高需求，這主要是由生物製劑的增長推動的。第一條生產線在現場。我們實際上正在招聘員工，驗證活動預計仍將在第四季度開始。在意大利的拉蒂納，驗證仍有望在今年夏天開始，然後在第四季度進行商業生產。

In summary, on Page 12, we are making substantial progress. First, we are shifting our revenue mix towards high-value solutions. Second, we continue to build strategic collaborations to leverage our strengths and meet customer demand. Third, we believe we are well positioned to capitalize on favorable industry trends such as the expected increase in GLP1s. And finally, we remain on track with our capacity expansion in the U.S. and Europe as we aim to build durable organic growth.

總之，在第 12 頁，我們正在取得實質性進展。首先，我們正在將收入組合轉向高價值解決方案。其次，我們繼續建立戰略合作以發揮我們的優勢並滿足客戶需求。第三，我們相信我們有能力利用有利的行業趨勢，例如 GLP1 的預期增長。最後，我們的目標是建立持久的有機增長，因此我們在美國和歐洲的產能擴張仍在軌道上。

With that, I now hand the call over to Marco.

有了這個，我現在把電話交給馬可。

Thanks, Franco. Before I begin, I want to clarify that all comparisons refer to the first quarter of 2022, unless otherwise specified.

謝謝，佛朗哥。在開始之前，我想澄清一下，除非另有說明，否則所有比較均指 2022 年第一季度。

Starting on Page 14. For the first quarter of 2023, revenue increased 12% to EUR 238 million or 11% on a constant currency basis, principally driven by growth in both segments and the shift to high-value solutions. We are making relevant progress growing our mix of high-value solutions, which increased 25% to EUR 76.7 million in the first quarter of 2023 and represented 32% of revenue. As expected, revenue from COVID-19 decreased 57% over the prior year and accounted for 4% of revenue in the quarter. For the first quarter of 2023, gross profit margin increased 20 basis points to 32% mainly driven by more accretive high-value solutions and to a lesser extent, margin improvement in the Engineering segment. As expected, this was offset by the increase in industrial costs and higher depreciation as our new plants come into service. We expect these temporary inefficiencies will continue throughout 2023 and this is assumed in our 2023 guidance.

從第 14 頁開始。2023 年第一季度，收入增長 12% 至 2.38 億歐元，或按固定匯率計算增長 11%，這主要是由於這兩個細分市場的增長和向高價值解決方案的轉變。我們在增加高價值解決方案組合方面取得了相關進展，該組合在 2023 年第一季度增長了 25% 至 7670 萬歐元，佔收入的 32%。正如預期的那樣，來自 COVID-19 的收入比上年下降了 57%，佔本季度收入的 4%。 2023 年第一季度，毛利率增長 20 個基點至 32%，這主要是由於更具增值性的高價值解決方案以及工程部門利潤率的改善所推動。正如預期的那樣，隨著我們的新工廠投入使用，這被工業成本的增加和折舊的增加所抵消。我們預計這些暫時的低效率將持續到 2023 年，我們的 2023 年指南中也假設了這一點。

Operating profit margin in the first quarter decreased 80 basis points to 17.1% mostly due to the higher SG&A expenses to support growth initiatives. Excluding start-up costs on the new plants, adjusted operating profit margin was 18.3% in the first quarter and consistent with the same period last year.

第一季度的營業利潤率下降 80 個基點至 17.1%，這主要是由於為支持增長計劃而增加的 SG&A 費用。不包括新工廠的啟動成本，第一季度調整後的營業利潤率為 18.3%，與去年同期持平。

For the first quarter of 2023, net profit totaled EUR 28.3 million, and we delivered diluted earnings per share of EUR 0.11. This included an unfavorable impact to diluted EPS of approximately EUR 0.01 recorded in finance expense due to the unexpected strengthening of the Mexican peso against the euro and the U.S. dollar. Excluding start-up costs, adjusted net profit was EUR 30.4 million and adjusted diluted EPS of EUR 0.11. Adjusted EBITDA increased 15% to EUR 61.9 million, and adjusted EBITDA margin was up 50 basis points to 26%.

2023 年第一季度，淨利潤總計 2830 萬歐元，每股攤薄收益為 0.11 歐元。這包括由於墨西哥比索兌歐元和美元的意外走強而對財務費用中記錄的約 0.01 歐元的攤薄每股收益產生不利影響。不包括啟動成本，調整後的淨利潤為 3040 萬歐元，調整後的攤薄每股收益為 0.11 歐元。調整後的 EBITDA 增長 15% 至 6,190 萬歐元，調整後的 EBITDA 利潤率增長 50 個基點至 26%。

Moving to segment results on Page 15. For the first quarter, revenue from the Biopharmaceutic and Diagnostic Solutions segment increased 13% or 12% on a constant currency basis to EUR 195.5 million over the same period last year. Revenue from high-value solutions increased 25% to EUR 76.7 million and revenue from other containment and delivery solutions increased 7% to EUR 118.8 million. Gross profit margin increased 80 basis points to 33.7% in the first quarter of 2023, mainly driven by the growing mix of more accretive high-value solutions. For the first quarter of 2023, operating profit margin for the BDS segment decreased to 19.8% mainly due to higher SG&A cost to support growth initiatives.

轉到第 15 頁的分部業績。第一季度，生物製藥和診斷解決方案分部的收入按固定匯率計算比去年同期增長 13% 或 12% 至 1.955 億歐元。來自高價值解決方案的收入增長 25% 至 7670 萬歐元，來自其他遏制和交付解決方案的收入增長 7% 至 1.188 億歐元。 2023 年第一季度毛利率增長 80 個基點，達到 33.7%，這主要是受更具增值性的高價值解決方案組合不斷增長的推動。 2023 年第一季度，BDS 部門的營業利潤率下降至 19.8%，主要原因是為支持增長計劃而增加的 SG&A 成本。

For the first quarter of 2023, revenue from the Engineering segment increased 7% to EUR 42.4 million driven by strong sales in visual inspection and assembly and packaging lines. For the first quarter of 2023, gross profit margin for the Engineering segment increased 30 basis points to 21.7%, driven by higher margins in all product families and ongoing business optimization effort. Improvement in gross profit margin and higher absorption of SG&A costs led to operating profit margin of 15.2% in the first quarter of 2023, an increase of 140 basis points over the same period last year.

2023 年第一季度，工程部門的收入增長了 7%，達到 4240 萬歐元，這主要得益於視覺檢測以及裝配和包裝線的強勁銷售。 2023 年第一季度，工程部門的毛利率增長了 30 個基點，達到 21.7%，這得益於所有產品系列的更高利潤率和持續的業務優化工作。毛利率的改善和 SG&A 成本吸收的增加導致 2023 年第一季度的營業利潤率為 15.2%，比去年同期增長 140 個基點。

On Slide 16, as of March 31, 2023, we had net debt for EUR 46.5 million and cash and cash equivalents of EUR 158.8 million. For the first quarter of 2023, net cash generated from operating activities was EUR 37.1 million and reflects our current working capital needs to support the growth in the business. As expected, capital expenditures for the first quarter of 2023 were EUR 113.2 million as we expand our industrial footprint amid rising customer demand. This was the main reason for negative free cash flow of EUR 91 million in the first quarter. We believe that our cash on hand, coupled with our loan agreements provides us with adequate liquidity to fund near-term growth.

在幻燈片 16 中，截至 2023 年 3 月 31 日，我們的淨債務為 4650 萬歐元，現金和現金等價物為 1.588 億歐元。 2023 年第一季度，經營活動產生的現金淨額為 3710 萬歐元，反映了我們當前的營運資金需求，以支持業務增長。正如預期的那樣，2023 年第一季度的資本支出為 1.132 億歐元，因為我們在客戶需求不斷增長的情況下擴大了我們的工業足跡。這是第一季度 9100 萬歐元負自由現金流的主要原因。我們相信，我們手頭的現金，加上我們的貸款協議，為我們提供了充足的流動性來為近期增長提供資金。

Lastly, on Page 17, we are reiterating our full year 2023 guidance. We continue to expect revenue in the range of EUR 1.085 billion to EUR 1.115 billion. Adjusted diluted EPS in the range of EUR 0.58 to EUR 0.62 and adjusted EBITDA in the range of EUR 290.5 million to EUR 302.5 million. Our 2023 guidance assumes that for the second quarter of 2023, revenue is expected to grow in the range of mid-single digits to high-single digits compared with the same period last year. Revenue will be stronger in the second half of 2023 compared with the first half of the year. High Value Solutions will represent approximately 32% to 34% of revenue. COVID-19 will represent approximately 2% to 3% of revenue. And lastly, we are estimating a currency headwind of approximately EUR 13 million to EUR 14 million.

最後，在第 17 頁，我們重申了 2023 年全年的指導方針。我們繼續預計收入在 10.85 億歐元至 11.15 億歐元之間。調整後的攤薄每股收益在 0.58 歐元至 0.62 歐元之間，調整後的 EBITDA 在 2.905 億歐元至 3.025 億歐元之間。我們的 2023 年指引假設 2023 年第二季度的收入預計將比去年同期增長中個位數至高個位數。與上半年相比，2023 年下半年的收入將更加強勁。高價值解決方案將佔收入的大約 32% 至 34%。 COVID-19 將佔收入的大約 2% 至 3%。最後，我們估計貨幣逆風約為 1300 萬至 1400 萬歐元。

Thank you. I hand the call to Franco for closing comments.

謝謝。我將電話轉給 Franco 以徵求結束意見。

Thanks, Marco. In closing, we are operating in an environment of favorable demand with attractive end markets characterized by strong secular tailwinds. We are executing against our strategic and operational priorities to capitalize on demand and support customers across the entire drug life cycle. We continue to make relevant progress as we advance our global expansion plans to increase our capacity in high-value solutions and enhance our proximity to customers. Grow our mix of high-value solutions as customers turn to ready-to-use formats and move up the product value chain. Invest in R&D to maintain and accelerate our market-leading position, and build a multiyear pipeline of new opportunities by supporting our customers through scientific innovation to meet their evolving needs. And lastly, we will host our first Capital Markets Day on September 27 in New York City. So, stay tuned for updates over the next few months.

謝謝，馬可。最後，我們在需求有利的環境中運營，終端市場具有吸引力，長期順風。我們正在執行我們的戰略和運營重點，以在整個藥物生命週期中利用需求和支持客戶。隨著我們推進全球擴張計劃以提高我們在高價值解決方案方面的能力並加強與客戶的距離，我們繼續取得相關進展。隨著客戶轉向即用型並提升產品價值鏈，增加我們的高價值解決方案組合。投資研發以保持和加速我們的市場領先地位，並通過科學創新支持我們的客戶滿足他們不斷變化的需求，從而建立一個多年的新機會管道。最後，我們將於 9 月 27 日在紐約市舉辦首個資本市場日。因此，請繼續關注接下來幾個月的更新。

And with that, let's open it up for questions.

有了這個，讓我們打開它來提問。

(Operator Instructions) The first question comes from Derik De Bruin of Bank of America.

（操作員說明）第一個問題來自美國銀行的 Derik De Bruin。

So I appreciate the incremental color on the GLP1s . I think one of the questions that we've gotten from investors is, I mean, obviously, these have been built around for a while, and you've been building capacity and providing this market for a while. How should we think about what potential incremental demand going here? I mean are the capacities you're building right now, Is it completely booked as it is for products? Or is there some flexible opportunity should demand go a little bit higher? Just trying to understand what's embedded in your guide for the GLP1s.

所以我很欣賞 GLP1 上的增量顏色。我認為我們從投資者那裡得到的一個問題是，我的意思是，顯然，這些已經建立了一段時間，並且您一直在建設能力並提供這個市場一段時間。我們應該如何考慮這裡有哪些潛在的增量需求？我的意思是你現在正在建設的能力，它是否像產品一樣完全預訂？或者是否有一些靈活的機會應該需求更高一點？只是想了解您的 GLP1 指南中包含的內容。

Derik, it's from -- it's a little bit challenging to hear you. I think your question relates to the incremental capacity that we're building as it relates to GLP1s. Is your question tied to the types of products that we're implementing as it relates to the capacity? Or could you clarify that?

德里克，它來自——聽到你的聲音有點挑戰。我認為你的問題與我們正在構建的增量能力有關，因為它與 GLP1 相關。您的問題是否與我們正在實施的與容量相關的產品類型有關？或者你能澄清一下嗎？

Yes. Basically, I was asking the capacity you're bringing on, what is -- is the capacity you're currently bringing on? Aligned mostly, is it already filled? Or is there some incremental -- or is there room for the growth? Maybe I'm just trying to figure out what is it. I mean, the GLP1 has been around for a while, I'm just trying to figure out what is already embedded in your guide versus what could be incremental to the business given this class of drug seems to be doing a little bit better?

是的。基本上，我問的是你帶來的能力，你目前帶來的能力是什麼？大部分對齊，是否已填充？或者是否有一些增量 - 或者是否有增長空間？也許我只是想弄清楚它是什麼。我的意思是，GLP1 已經存在了一段時間，我只是想弄清楚您的指南中已經嵌入了哪些內容，以及考慮到此類藥物似乎做得更好一些，哪些內容可以增加業務？

Thank you, Derik, for your question. To start saying that all the growth opportunity we have in front of us are not at least specifically to any single therapeutic area. And we are investing in high-value solution because we see in the biologics space, the most important opportunity that not only for the GLP1, but includes also other area of technologies like monoclonal antibodies, mRNA application. And then we look also to an expansion in the biosimilar space for biologics. That said, obviously, also GLP1 opportunities are embedded in our plan for the year and in our CapEx execution to have enough capacity to match customer demands in the years to come, and we are executing accordingly. Thank you.

德里克，謝謝你的問題。首先要說的是，我們面前的所有增長機會至少都不是專門針對任何一個治療領域的。我們正在投資高價值的解決方案，因為我們在生物製劑領域看到了最重要的機會，不僅對 GLP1，而且還包括其他技術領域，如單克隆抗體、mRNA 應用。然後我們還期待生物仿製藥領域的擴張。也就是說，很明顯，GLP1 機會也包含在我們今年的計劃和我們的資本支出執行中，以便有足夠的能力在未來幾年滿足客戶需求，我們正在相應地執行。謝謝。

A little bit of clarity on the second quarter guidance, mid- to high single-digit revenue growth. That was below sort of like where the consensus estimates were and we -- can we sort of talk about pacing of revenues on the back of the quarter? I mean you have a really tough comp in the fourth quarter. Do you -- so I mean just the way the guide reads, it's a little bit more back-end loaded. Can you just talk about how we should think about pacing for the rest of the year in revenue?

第二季度的指引有點清晰，中高個位數的收入增長。這有點像共識估計的水平，我們 - 我們可以談談本季度末的收入節奏嗎？我的意思是你在第四節的表現非常艱難。你 - 所以我的意思是指南的閱讀方式，它有更多的後端加載。你能談談我們應該如何考慮今年剩餘時間的收入節奏嗎？

Yes. Derik, in the second half of the year, we expect higher revenue than in the first half similarly to what we have done last year. This year, in particular, we can see strong revenue in second half due to the visibility we have in our backlog and in the forecast from our customers. And on top of it, you know very well, we are installing capacity in Italy that we've been generating further revenue than in the second part of the year. So this is what we can see today. We reiterate our guidance for the full year. We expect the second quarter mid-single digit to high single-digit growth compared to last year's same period.

是的。 Derik，在今年下半年，我們預計收入會比上半年更高，這與我們去年所做的類似。特別是今年，由於我們在積壓訂單和客戶預測中的可見性，我們可以在下半年看到強勁的收入。最重要的是，你非常清楚，我們正在意大利安裝產能，我們比今年下半年產生了更多的收入。這就是我們今天所看到的。我們重申全年的指引。我們預計第二季度與去年同期相比將實現中個位數到高個位數的增長。

The next question is from Paul Knight of KeyBanc Capital Markets.

下一個問題來自 KeyBanc Capital Markets 的 Paul Knight。

This would probably be for Marco Dal Lago. The question I have is when I look at COVID revenue in past periods, was that evenly distributed through all product lines? Or was it within the Biopharma and Diagnostics Solutions group?

這可能是給 Marco Dal Lago 的。我的問題是，當我查看過去期間的 COVID 收入時，它是否均勻分佈在所有產品線中？還是在生物製藥和診斷解決方案集團內？

It's totally referred to the BDS segment. The main format used for COVID treatment are buyers, both in (inaudible) this configuration. As expected, we can see a slowdown in COVID as anybody has. And we reiterate our guidance to have between 2% and 3% of revenue from COVID in 2023.

它完全是指BDS段。用於 COVID 處理的主要格式是買家，都在（聽不清）這種配置中。正如預期的那樣，我們可以像任何人一樣看到 COVID 放緩。我們重申我們的指導意見，即 2023 年 COVID 收入佔收入的 2% 至 3%。

Okay. So high-value solutions was where most COVID would go -- revenue was recognized, Marco?

好的。所以高價值的解決方案是大多數 COVID 會去的地方——收入得到確認，Marco？

COVID business, we haven't experienced a different mix compared to the rest of the company between high value and other containment delivery solution. So we expect this (inaudible) COVID will not affect our business.

COVID 業務，與公司其他部門相比，我們在高價值和其他遏制交付解決方案之間沒有經歷過不同的組合。因此，我們希望這種（聽不清）COVID 不會影響我們的業務。

And then regarding the outlook on GLP1s. Franco, what -- is there any estimate that you believe you have in terms of market share for this developing market of GLP1s?

然後是關於 GLP1 的前景。 Franco，你認為你在這個發展中的 GLP1 市場的市場份額方面有什麼估計嗎？

Yes, you know that all the estimates for this business line in GLP1 talked about multibillion overall business. And important for us is that in this business, we have the right mix of products that are cartridges in bulk configuration and EZ-fill configuration and also syringes that are needed for the auto-injector. The current situation is overweighted in term of cartridges and by cartridges because it is more (inaudible) with the past. And GLP1 is something that is commercial since many years, it's not completely new. We expect the evolution of this market going in the direction of high-value solutions, both for EZ-fill cartridges and high-value syringes. That said, we expect to have a fair share of these market opportunities because we are the leader in the market for pen cartridges. And we are the second most important player in the syringes space. So we expect to have a fair share of these opportunities and our visibility is giving us a good prospect in this direction.

是的，你知道 GLP1 中對這個業務線的所有估計都談到了數十億美元的整體業務。對我們來說重要的是，在這項業務中，我們擁有正確的產品組合，即散裝配置的墨盒和 EZ-fill 配置以及自動注射器所需的注射器。目前的情況在彈藥筒和彈藥筒方面都超重了，因為它與過去相比（聽不清）。 GLP1 多年來一直是商業化的東西，它並不是全新的。我們預計該市場將朝著高價值解決方案的方向發展，包括 EZ-fill 藥筒和高價值注射器。也就是說，我們希望在這些市場機會中佔有公平的份額，因為我們是筆芯市場的領導者。我們是注射器領域第二重要的參與者。因此，我們希望能公平地分享這些機會，我們的知名度為我們在這個方向上提供了良好的前景。

Okay. And then lastly, Franco, is the -- when will Latina and when will Indiana, in your opinion, be generating revenue?

好的。最後，Franco，您認為 Latina 和 Indiana 什麼時候會產生收入？

We are on track with our plans. And so we expect to have a commercial sales from Latina in the last quarter of this year. And validation activity in Fisher, Indiana under completion in the last part of the year to have a first revenue generation in the first part of '24.

我們正在按計劃進行。因此，我們預計今年最後一個季度將有 Latina 的商業銷售。印第安納州 Fisher 的驗證活動在今年下半年完成，將在 24 世紀上半年產生第一筆收入。

Next question is from Patrick Donnelly from Citi.

下一個問題來自花旗的 Patrick Donnelly。

You have Lizzy on for Patrick. So just one more question on the second quarter guide. How should we think about margins? And then for the back half of the year as well, should we think of second half margins as higher than first half along with revenue as you discussed before?

你讓 Lizzy 代替 Patrick。所以關於第二季度指南還有一個問題。我們應該如何考慮利潤率？然後對於今年下半年，我們是否應該像您之前討論的那樣認為下半年的利潤率和收入一起高於上半年？

Thank you for the question. In the second part of the year, we expect to keep on having the similar mix we have been in Q1. We are -- our guidance is between 42% to 44% of high-value solutions. We will have some better opportunity to leverage our fixed expenses in the second part of the year due to the higher revenue. On the other side, we expect some inefficiencies related to the start-up cost of the new facilities in Indiana and the Latina in Italy. But overall, we plan to expand our margin in the second part of the year.

感謝你的提問。在今年下半年，我們預計將繼續保持與第一季度類似的組合。我們是 - 我們的指導是 42% 到 44% 的高價值解決方案。由於收入增加，我們將有更好的機會在今年下半年利用我們的固定費用。另一方面，我們預計印第安納州和意大利拉蒂納的新設施的啟動成本會導致效率低下。但總體而言，我們計劃在今年下半年擴大利潤率。

And then on the China facility, I think you mentioned last quarter you were pausing for now and then resuming planning and development in 2024. Is that still the right way to think about it? Just given there's so much demand in the U.S. and Europe, I guess, for GLP1s? And that's it for me.

然後關於中國工廠，我想你提到上個季度你暫時暫停，然後在 2024 年恢復規劃和開發。這仍然是正確的思考方式嗎？鑑於美國和歐洲對 GLP1 的需求如此之大，我猜？對我來說就是這樣。

We confirm that what we said also during the last call, we are allocating our capital where we see the best opportunity and closer need of our customers. So we decided to accelerate investment in Italy and in Fisher in Indiana because there is the opportunity to leverage on the strong demand there.

我們確認，我們在上次電話會議中也說過，我們正在將資金分配給我們認為最好的機會和客戶更密切的需求。因此，我們決定加快在意大利和印第安納州 Fisher 的投資，因為有機會利用那裡的強勁需求。

In China, we remain a strategic target for us in terms of market, and we decided to pause the investment for a while, and we still expect to take a decision for a new start of the initiative some time in '24.

在中國，就市場而言，我們仍然是我們的戰略目標，我們決定暫停投資一段時間，我們仍然希望在 24 年的某個時候做出重新啟動該計劃的決定。

The next question is from Tim Daley of Wells Fargo.

下一個問題來自富國銀行的蒂姆戴利。

So I did want to dig a bit on the market dynamics on self-injectables. So I appreciate the color and the commentary around Stevanato's #1 position in pen cartridges. And I think you mentioned you're #2 in auto-injectors. I believe Wegovy and Ozempic are single shot injectors, so kind of that auto-injector #2 position. Just given the attitudes around waste, environmental, plastics, et cetera, does this market like allow itself or does the drug allow itself to be utilized in a pen cartridge approach to a multi-dose injector? Or just any color there around, this is a very attractive market, just happens for the year, that's your #2 position with your #1. And any potential for this dynamic to change in terms of the delivery mechanism.

所以我確實想深入了解自我注射劑的市場動態。因此，我很欣賞 Stevanato 在筆芯中排名第一的顏色和評論。我想你提到過你在自動注射器中排名第二。我相信 Wegovy 和 Ozempic 是單次注射器，所以那種自動注射器 #2 位置。考慮到對廢物、環境、塑料等的態度，這個市場是否允許自己或藥物允許自己用於多劑量注射器的筆筒方法？或者只是周圍的任何顏色，這是一個非常有吸引力的市場，今年恰好發生，這是您的 #2 位置和您的 #1。以及這種動態在交付機制方面發生變化的任何可能性。

Yes. First of all, I have to reiterate that GLP1 is something that is commercial since a while the introduction of the (inaudible) and was approved by FDA in 2005, and we are in the business from 2010 for GLP1. So there is a current situation that is more linked to the format for delivery adopted at the beginning where the only format for cartridges was the bulk one. And the pen injector has been the first delivery system adopted globally.

是的。首先，我必須重申，GLP1 是商業化的東西，因為引入（聽不清）並於 2005 年獲得 FDA 批准，我們從 2010 年開始從事 GLP1 業務。因此，目前的情況更多地與一開始採用的交付格式有關，其中唯一的墨盒格式是散裝的。筆式註射器是全球採用的第一個輸送系統。

As it's still the dominant one, it doesn't mean that the new treatment are not a targeted different delivery format, trying to adjust to the patient needs and preferences and for us, it's very important to be able to serve both formats, pen injector with the cartridges in the half EZ-fill cartridges that are for multiple use and also auto-injector with syringes that are for single use at the moment with the current technology.

因為它仍然是主要的，這並不意味著新的治療不是有針對性的不同的交付形式，試圖適應患者的需求和偏好，對我們來說，能夠提供兩種形式的筆式註射器是非常重要的使用可多次使用的半 EZ-fill 藥筒中的藥筒，以及目前使用當前技術僅供一次性使用的帶注射器的自動注射器。

It's also important for us that auto-injector needs very high-quality syringes with the special performances in terms of mechanical resistance and also the driving force to let the auto-injector works well. And our strength, it will be present both formats. And there is the reason why we are not targeting one single opportunity, but we are ready to serve our customers in both ways.

對我們來說同樣重要的是，自動注射器需要非常高質量的注射器，這些注射器在機械阻力方面具有特殊性能，並且需要讓自動注射器良好工作的驅動力。而我們的實力，將同時呈現兩種形式。這就是為什麼我們不針對一個機會，而是準備以兩種方式為客戶服務的原因。

Tim, the only thing I want to add to that is that we are seeing different approaches by different customers. And it's also important to point out that there are different approaches regionally as well.

蒂姆，我唯一想補充的是，我們看到不同客戶採用不同的方法。同樣重要的是要指出，地區間也有不同的方法。

All right. No, I do appreciate all that color. And then just curious on the order intake in the quarter. Just curious, is there -- can you give us a net new business growth rate on ex COVID basis to help us understand kind of the book-to-bill dynamics, when we take COVID out of the revenues and take COVID out of the orders.

好的。不，我很欣賞那種顏色。然後只是對本季度的訂單量感到好奇。只是好奇，有沒有——當我們從收入中剔除 COVID 並從訂單中剔除 COVID 時，您能否給我們一個基於 COVID 前的淨新業務增長率，以幫助我們了解訂單到賬單的動態變化.

Was your question, new order intake ex COVID Tim, Sorry it was a little...

你的問題是，前 COVID Tim 的新訂單攝入量，抱歉，有點……

Just trying to get to the book-to-bill on a clean kind of non-COVID basis.

只是想在一種干淨的非 COVID 基礎上實現訂單到賬單。

Yes, we are looking at this trying about order intake, but I want to stress that the order intake and macro they are good indicators of the demand, but it is not the only way we have visibility into the customer needs because we have always talks with customers and also discussion about the long-term agreement, multiyear agreement. The visibility in (inaudible), in this sense, much higher, much deeper than only what is committed orders because of backlog and order intake is only for -- we consider fully committed orders. Sometimes the customer has to wait for issuing the committed order because they don't have already set the supply chain channel where they wanted to fill the container. So committed orders are and order intake are good indicators, but we have much better visibility and this visibility that allows us to plan the future and our CapEx.

是的，我們正在研究關於訂單攝入量的嘗試，但我想強調訂單攝入量和宏觀它們是需求的良好指標，但這不是我們了解客戶需求的唯一方式，因為我們一直在談論與客戶討論長期協議，多年協議。從這個意義上說，（聽不清）的可見性比僅因為積壓和訂單接收而承諾的訂單要高得多，更深得多 - 我們認為完全承諾的訂單。有時，客戶必須等待發出已提交的訂單，因為他們尚未設置他們想要填充容器的供應鏈渠道。所以承諾訂單和訂單攝入量是很好的指標，但我們有更好的可見性和這種可見性，使我們能夠規劃未來和我們的資本支出。

The next question is from Dave Windley of Jefferies.

下一個問題來自 Jefferies 的 Dave Windley。

I wanted to follow up on Tim's question on the committed orders. So if I look at the magnitude of COVID revenue, in last year and this year, which would have been in the kind of EUR 22 million last year and maybe EUR 9-ish, EUR 9.5 million, EUR 10 million this year. I'm guessing that the order of magnitude for COVID would have been something around those numbers. Your change in orders year-over-year is EUR 88 million. So it would seem like the majority of the change in orders year-over-year probably comes from the non-COVID region. The changes in timing of orders. So I wondered if you could peel that apart a little bit, confirm what I'm thinking and maybe talk about what's happening in your order flow aside from COVID -- ex COVID.

我想跟進蒂姆關於已提交訂單的問題。因此，如果我看一下去年和今年 COVID 收入的規模，去年可能是 2200 萬歐元，今年可能是 9 歐元、950 萬歐元、1000 萬歐元。我猜 COVID 的數量級應該是圍繞這些數字的。您的訂單同比變化為 8800 萬歐元。因此，看起來訂單同比變化的大部分可能來自非 COVID 地區。訂單時間的變化。所以我想知道你是否可以把它拆開一點，確認我在想什麼，也許可以談談你的訂單流程中發生的事情，除了 COVID——ex COVID。

Yes. Thanks, Dave, for the question. Marco speaking. You are right. Last year, we won about EUR 41.5 million of fresh orders in the first quarter related to COVID year, the amount is zero. If we look at the fluctuation, excluding COVID, yes, we had EUR 282 million last year and EUR 245 million this year. But it's normal for us and in quarterly equation in (inaudible). And as Franco was mentioning, this is not the sole indicator. We have to measure the demand coming from the market. So we experienced fluctuation, but this is not the only indicator we have.

是的。謝謝戴夫提出這個問題。馬爾科說話。你是對的。去年，我們在第一季度獲得了與 COVID 相關的約 4150 萬歐元的新訂單，金額為零。如果我們看一下波動，不包括 COVID，是的，我們去年有 2.82 億歐元，今年有 2.45 億歐元。但這對我們來說是正常的，並且在（聽不清）的季度等式中。正如佛朗哥所說，這不是唯一的指標。我們必須衡量來自市場的需求。所以我們經歷了波動，但這不是我們擁有的唯一指標。

Got it. And related to that, you're talking about stronger growth in the second half. Can you talk about the visibility that you do have to that? Either in the committed orders around the...

知道了。與此相關的是，你在談論下半年更強勁的增長。你能談談你對此的可見性嗎？要么在周圍的承諾訂單中......

Yes, considering the Q1 revenues and the committed backlog only, we are covered for about 80% of the center point of our guidance. So we still have 9 months to generate the fresh order and to convert them into revenues for reaching our guidance.

是的，僅考慮第一季度的收入和承諾的積壓，我們涵蓋了我們指導中心點的大約 80%。因此，我們還有 9 個月的時間來生成新訂單並將其轉化為收入以達到我們的指導。

But maybe we can confirm that the very normal situation at this time of the year. Nothing that is different from the past, even if you don't consider the different situation we experienced during COVID, but it's a very normal situation for the first quarter.

但也許我們可以確認每年這個時候的情況非常正常。與過去沒有什麼不同，即使你不考慮我們在 COVID 期間經歷的不同情況，但這對第一季度來說是一個非常正常的情況。

Got it. Great. On the cost side, you highlighted some additions in SG&A costs in BDS, I suspect those are higher as you get closer to opening facilities in Latina and Indiana, you can correct me if I'm wrong there. But I'm wondering if that continues to ramp as we get closer to commercial revenue in those facilities? Or have we seen a step function that now is more flat as we proceed through the year?

知道了。偉大的。在成本方面，你強調了 BDS 中 SG&A 成本的一些增加，我懷疑隨著你接近在拉蒂納和印第安納州開設設施，這些成本會更高，如果我錯了，你可以糾正我。但我想知道，隨著我們越來越接近這些設施的商業收入，這種情況是否會繼續增加？或者我們是否看到了一個階躍函數，隨著我們一年的進行，現在變得更加平坦？

We expect SG&A will be better leverage in the second part of the year. We are increasing SG&A expenses, mainly driven by wary of the past that we will start meeting customers doing fair exhibition. And we are also strengthening the organization in G&A expenses with the regional organization and the public company status. Nevertheless, we expect in the second part of the year to better leverage our fixed expenses due to the growth of our business.

我們預計 SG&A 將在今年下半年發揮更好的槓桿作用。我們正在增加 SG&A 費用，主要是出於對過去我們將開始會見客戶進行公平展覽的警惕。我們還在以區域組織和上市公司身份加強 G&A 費用的組織。儘管如此，我們預計在今年下半年，由於我們業務的增長，我們將更好地利用我們的固定費用。

Next question is from John Sourbeer of UBS.

下一個問題來自瑞銀的 John Sourbeer。

Hello. This is Tianqi calling in for John. So very good high value solution, HVS growth in this quarter. Can you talk a little bit more about the traction with customer on HVS? What is the typical planning on both of these new products? And what are the drivers to get to this long-term mid-30 percentage target?

你好。我是天啟找約翰。所以非常好的高價值解決方案，本季度 HVS 增長。你能多談談 HVS 對客戶的吸引力嗎？這兩種新產品的典型規劃是什麼？實現這個 30% 的長期中期目標的驅動因素是什麼？

Just to confirm, your question is around high value solutions and some of the drivers to get to our near-term target of the high 30%?

只是確認一下，您的問題是關於高價值解決方案和實現我們近期目標 30% 的一些驅動因素？

Yes, that's correct. And also, what's the typical time you take for introducing new products in HVS?

對，那是正確的。另外，您在 HVS 中推出新產品通常需要多長時間？

Yes, the main driver for the growth of higher-value solutions is the fast-growing area of biologics, where we have very strong demand related not only to GLP1s, as I mentioned before, but also in monoclonal antibodies, mRNA application. And this is the evidence that our strategy to invest in high-value solution is really something that matches the needs of our customers. And the fact that we decided to accelerate our investment both in Europe and Italy and in the U.S. is because we have active programs with our customers. The timing direction of the adoption of EZ-fill cartridges and buyers as a new standard in that space and high-value syringes like Nexa syringes for injectors and other syringes that is the perfect answer to the need of high sensitive biologic molecules.

是的，高價值解決方案增長的主要驅動力是快速增長的生物製品領域，正如我之前提到的，我們不僅對 GLP1 有非常強烈的需求，而且對單克隆抗體、mRNA 應用也有強烈需求。這證明我們投資高價值解決方案的戰略確實符合客戶的需求。事實上，我們決定加快在歐洲、意大利和美國的投資，是因為我們與客戶有積極的計劃。採用 EZ-fill 墨盒和買家作為該領域的新標準的時間方向和高價值注射器，如用於注射器的 Nexa 注射器和其他注射器，是滿足高靈敏度生物分子需求的完美答案。

If I could just squeeze one more. Can you talk a little bit more on pricing? What kind of like inflationary pressure are you experiencing in the quarter? And any pushback from customers on those pricing dynamics?

如果我能再擠一個就好了。你能多談談定價嗎？您在本季度遇到了什麼樣的通貨膨脹壓力？客戶對這些定價動態有什麼反對嗎？

May I ask you to repeat the question one last time?

我可以請你最後再重複一遍這個問題嗎？

Yes, sure. So can you talk a little bit more on pricing? What kind of inflationary sort of like pressure are you experiencing in the quarter? And are you receiving any push back from customers on the pricing dynamics?

是的，當然。那麼你能多談談定價嗎？您在本季度遇到了什麼樣的通貨膨脹之類的壓力？您是否收到客戶對定價動態的任何反對意見？

Yes, we can see inflation as anybody else, there are different level of inflation depending on the items. For example, we had a little bit of relief in energy cost and gas price in the first quarter. But on the other hand, cost of labor is growing. So our methodology is the same, we applied last year planning in advance, more in advance compared with last year, but we keep on recalculating our cost basis and price accordingly to our customers.

是的，我們可以像其他人一樣看到通貨膨脹，不同的物品有不同程度的通貨膨脹。例如，我們在第一季度的能源成本和天然氣價格有所緩解。但另一方面，勞動力成本正在增長。所以我們的方法是一樣的，我們提前應用了去年的計劃，比去年提前了更多，但我們繼續根據客戶重新計算我們的成本基礎和價格。

(Operator Instructions) This ends the Q&A session. Ladies and gentlemen, thank you for joining. The conference is now over, and you may disconnect your telephones.

（操作員說明）這結束了問答環節。女士們，先生們，感謝你們的加入。會議現已結束，您可以斷開電話。