Good afternoon. Welcome and thank you for joining the Stevanato Group First Quarter 2024 Earnings Call. At this time, I would like to turn the conference over to Ms. Lisa Miles, Senior Vice President, Investor Relations. Please go ahead, madam.

Good morning, and thanks for joining us. With me today is Franco Stevanato, Executive Chairman; Franco Moro, CEO; and Marco Dal Lago, CFO. You can find a presentation to accompany today's results on the Investor Relations page of our website, which can be found under the Financial Results tab. 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 on March 7, 2024. Please take a moment to read our Safe Harbor statements included in the front of the presentation and also in today's press release. 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. Today's presentation may contain non-GAAP financial information. Management uses this information in its internal analyses 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. And with that, I will now hand the call to Franco Stevanato for opening remarks.

Thank you, Lisa, and thanks for joining us. Today, we will review our first quarter performance, address our guidance change, and provide an update on our markets and the dynamics we are seeing today. While first quarter results did not meet our expectations, the fundamentals of our business have not changed, and the demand landscape remains robust. We are tackling two challenges today, and our number one priority is execution. First, the impact from the industry-wide temporary destocking was more pronounced than previously expected, especially in the more accretive EZ-fill vials. Customers are still working down excess inventories that were stockpiled during the pandemic. This has resulted in a temporary softening in demand for both bulk and ready-to-use vials. But we believe once the market rebounds, vials will return to normalized market growth rates. Second, in the Engineering business, we enjoyed a period of record orders in the second half of 2022. This large volume of work and long lead times for components put stress on our organization last year. But, while external factors played a role, our execution simply could have been better. We've taken many actions over the last year. And we believe these steps will help us achieve a more optimized operational structure to maximize efficiencies and secure the success of projects going forward. I would like to take a moment to address our updated guidance. The temporary destocking is the main factor in our guidance change. Our updated guidance also assumes a recent postponement of expected orders for high-value solutions for a large customer that were forecasted to be shipped in 2024. This was due to a change in the customer's commercialization timeframes. But nevertheless, we have removed the forecasted orders from our guidance. Despite these factors, we remain confident about our long-term prospects, and we remain on the right path to achieve our near-term targets in 2027. Our unique value proposition of integrated offerings ideally positions Stevanato Group to capitalize on favorable secular tailwinds such as aging populations with more complex health conditions; pharma innovation, particularly in sensitive biologics; and the trend towards the self-administration of medicines. We operate in growing end markets, and we are well positioned in the fastest growing biologics segment. We believe we have a leading presence in GLP1s, underpinned by long-term commercial contracts. And we see many opportunities primarily in biologics over the next several years. Above all, our global footprint, differentiated product portfolio, and integrated end-to-end solutions offer customers a unique value proposition. This provides us with sustainable competitive advantages. I will now hand the call over to Marco.

Thanks, Franco. Before I begin, I want to clarify that all comparisons refer to the first quarter of 2023 unless otherwise specified. Starting on Page 7, for the first quarter of 2024, revenue decreased 1%, and 40 basis points on a constant currency basis, to EUR 236 million. The Biopharmaceutical and Diagnostic Solutions Segment grew 2%, which partially offset the expected decline in the Engineering Segment. The revenue decrease in the first quarter was mainly driven by lower revenue related to glass vials in the BDS Segment due to the industry-wide destocking, which we believe is transitory. Our product diversity helped expand our mix of high-value solutions, which represented 37% of total revenue in the first quarter. However, the product mix within high-value solutions was less accretive compared with the same period last year, mainly due to lower volumes from EZ-fill vials. For the first quarter of 2024, the lower revenue from EZ-fill vials was the largest factor in the gross profit margin decrease to 26.4%. In addition, the underutilization on vial lines, lower gross profit from the Engineering Segment, temporary inefficiencies in our new manufacturing plants, and higher depreciation also impacted gross profit margin, but to a much lesser extent. Lastly, the prior-year period also benefited from government grants that helped offset the spike in utility costs that did not repeat in the first quarter of 2024. This led to an operating profit margin of 10.7%. On an adjusted basis, the operating profit margin was 12.3%. For the first quarter of 2024, net profit totaled EUR 18.8 million, and diluted earnings per share were EUR 0.07. On an adjusted basis, net profit was EUR 21.5 million, and adjusted diluted earnings per share were EUR 0.08. Adjusted EBITDA was EUR 50.6 million, and adjusted EBITDA margin was 21.4%. Moving to Segment results on Page 8, for the first quarter of 2024, revenue from the BDS Segment increased 2% to EUR 198.9 million. Segment growth was impeded by the industry-wide vial destocking. And in the first quarter of 2024, revenue from vials decreased 43%. This was offset by strong growth in syringes and other product categories. High-value solutions grew 15% to EUR 88 million in the first quarter, while revenue from other containment and delivery solutions decreased 7% to EUR 111 million. For the first quarter of 2024, the change in product mix due to the lower revenue from EZ-fill vials had the most profound impact on the gross profit margin of 27.1%. Gross profit margin was also tempered by the underutilization of vial lines and associated labor costs, the temporary inefficiencies from start-up, higher depreciation, and government grants that did not repeat in 2024. As a result, the operating profit margin for the BDS Segment decreased to 14.1%. For the first quarter of 2024, revenue from the Engineering Segment decreased 13% to EUR 37.1 million due to lower sales from pharmaceutical visual inspection and assembly and packaging lines. As previously discussed, our main priority in 2024 is executing the large volume of work in progress and shortening our lead times. We have hired additional labor resources to support these efforts, along with other important long-term projects in the pipeline. In the first quarter of 2024, gross profit margin from the Engineering Segment decreased to 17.3% due to lower marginality from certain projects in process. This led to an operating profit margin of 6.7% in the quarter. Please turn to the next slide for a review of balance sheet and cash flow items. In March, we closed our follow-on offering and raised net proceeds of EUR 170.5 million. The proceeds will be used for our capital investment projects, working capital needs, and general corporate purposes to ensure an appropriate level of operating and strategic flexibility. With the cash infusion from the offering, we ended the quarter with cash and cash equivalents of EUR 186.3 million and net debt of EUR 186.9 million. We believe our cash on hand gives us adequate liquidity to fund our strategic priorities. As expected, capital expenditures for the first quarter of 2024 totaled EUR 71.9 million, with approximately 88% tied to growth investments to advance our ongoing capacity expansion for high-value solutions. We continue to carefully manage trade working capital to support the growth of our business. In the first quarter, we benefited from strong collections of receivables, which drove cash generation. But as expected, our inventory levels increased in the first quarter, mainly due to the establishment of baseline inventories in our new plants, which includes products that are expected to be delivered to customers in the future quarters. In the first quarter of 2024, net cash from operating activities totaled EUR 71.6 million. Cash used in the purchase of property, plant, and equipment, and intangible assets was EUR 102.7 million. This drove negative free cash flow of EUR 30.6 million in the first quarter. Lastly, we are updating our full year 2024 guidance on Page 10. As Franco mentioned, the combination of temporary soft vial demand and the postponement of a large customer order are the main reasons for taking a more cautious approach to our 2024 guidance. Our guidance now assumes a more gradual recovery in vials. We currently expect that vial orders will increase at the end of 2024 and into early 2025, with bulk vials expected to recover first. While our recent public offering had limited impact on dilution in the first quarter, our updated guidance includes the increase in weighted average shares outstanding. For fiscal 2024, we now expect revenue in the range of EUR 1,125 million to EUR 1,155 million; adjusted EBITDA in the range of EUR 277.9 million to EUR 292.2 million; and adjusted diluted EPS in the range of EUR 0.51 to EUR 0.55. Thank you. I will hand the call to Franco Moro.

Thank you, Marco. Starting on Slide 12, over the last several weeks, we have spent a lot of time with our customers as they continue to manage excess vial inventories. As Marco noted, we now anticipate a slower recovery in vials, particularly EZ-fill vials, which will unfavorably impact our mix of high-value solutions in 2024. It's important to remember that the ready-to-use vials are currently a small portion of the market, and the vast majority of vials are in bulk configurations. We are the market leader in ready-to-use vials, and the temporary imbalance of supply and demand is having a pronounced impact for us, given our significant position in the market, coupled with the low volumes in the market today. In the near term, we are carefully managing costs, and we have taken many actions on the labor side, including redeploying vial production staff and improving efficiencies in maintenance activities, while some vial lines are idle. At the same time, we expect to retain most of the staff who work on our vial production lines despite the temporary underutilization. We believe this approach best positions us to be prepared for the recovery, especially considering the time it takes to recruit, hire and train new staff to achieve full productivity. We believe it's the right thing to do for our business, and we do not want to take short-term actions that might compromise our future growth. Turning to the Engineering Segment, the actions that we initiated last year are just starting to yield operational improvements in the business. The combination of additional resources, ongoing optimization of our industrial footprint, and streamlining internal processes are helping to improve the overall health of the business. These actions are ongoing, but improvements will take time. We expect that in the long run, they will drive operational efficiencies and shorten lead times, which in turn will benefit the segment's margins. Longer term, we believe the demand landscape in Engineering remains favorable. For example, the self-administration of medicine is a growing trend, especially given the popularity of GLP1s, as patients become more comfortable with drug delivery devices like pen injectors and autoinjectors. This trend is generating customer demand for our assembly and packaging lines, and we are supporting many customers as they rapidly expand their device programs. Let's turn to Page 13 for a brief update of our expansion projects. In Fishers, we remain on track to begin commercial production in the second half of 2024. Customer-related validation activities are in full swing and will continue into 2026, as planned. In the meantime, we expect to deliver and install several more manufacturing lines in the coming months. Following the completion of our performance qualifications, customer validations will begin on these new lines. In addition, we are set to begin the build-out of our contract manufacturing capabilities in Fishers related to a drug delivery platform for multiple biologic indications for a large customer. Commercial activities related to this new CMO work are expected to begin in 2026. In Latina, ramp-up activities are ongoing as we continue installing and validating new lines into 2026. Commercial production launched last year, and revenue is expected to grow over the next several years. I'll hand the call back to Franco Stevanato for closing remarks.

Thank you, Franco. In closing, Stevanato Group has cemented its leadership position as a mission-critical partner in the pharmaceutical supply chain. We have experienced significant growth, and we have been building the organization to support our long-term objectives. Our number one priority in 2024 is execution. We are laser-focused on ramping up our new capacity to meet rising customer demand for high-value solutions such as our Nexa syringes and EZ-fill cartridges. We are also strengthening our processes and driving efficiencies across our global operations to best manage our future growth. These are exciting times. We offer a unique value proposition of integrated solutions and differentiated products that resonate with customers. We operate in attractive end markets with long secular tailwinds. These factors favorably position us to drive durable organic growth, expand margins, and deliver long-term shareholder value. Operator, let's open it up for questions.

The first question is from Michael Ryskin with Bank of America.

Great. I want to dig in first on the inventory comments, obviously. It's something that's been going on in the industry for a number of months now. I wouldn't say it's exactly a surprise. But can you give us a little bit more color on what changed as you went through the quarter? If you look back to where you were in March versus where you are now, in early March when you reported 4Q and initially guided for the year, you provided some color on destocking, but clearly, you underestimated the problem. So is this something that changed during the quarter? Is this something where you've got better visibility in customers? And I'll tack on the follow-on immediately after that is, the new outlook that you're giving, what gives you confidence that destocking will fade as you go through the year? Is there any level of conversations you can have with customers or anything like that point to the improved timelines?

Thanks, Mike. Just to make sure we've captured all of your questions, first on what's changed since our last earnings call on destocking. And secondly, the confidence in the fact that destocking will continue to fade and we'll see that recovery later in the year on the new outlook. So I'm going to hand that over to Franco Stevanato to begin.

Yes. Thank you. So the pandemic presented extraordinary challenges across our industry, and we are still on the path to normalization, but the market is still choppy today. First, the impact from destocking was simply more pronounced than previously expected. Frankly, the pandemic created a fast acceleration of vial demand as customers stockpiled inventory. We previously anticipated a slower path to normalization. But instead, we experienced a more rapid decline in vial demand due to excess inventory. In this context, customers and us, by consequence, faced challenges in anticipating and predicting the right timing and intensity of the demand. This caught us partially off guard. This, at the end of the game, is a temporary dynamic that is impacting 2024. Once completely over, we anticipate that we'll return to pre-pandemic market growth rates. This includes low-single digit growth for bulk vials and double-digit growth for ready-to-use vials.

And Mike's follow-up is the confidence that we see in the fading of the destocking throughout the year.

Yes. During this year, as said by Franco, we see a more difficult condition than previously anticipated. We don't see, during this year, an increase in the following quarters with respect to vials and EZ-fill vials. As mentioned during the commentary, we now expect orders to start increasing towards the end of the year with bulk vials starting first and immediately after the EZ-fill vials. We mentioned also the fact that we went down 43% year-over-year in vials. And as you said, this headwind is stronger than what we anticipated. We expected a lower reduction in vials, but as a matter of fact, this is what we can see today, and this is the main difference compared to two months ago.

Correct. If I can further elaborate, Michael, we have a very close and intense relationship with our customer, particularly for the supply chain related to research and development and engineering department. On one hand, in 2024, we see the customer looking to bring the inventory back to the original scenario towards pre-pandemic levels. In parallel, we are starting to see more and more of our big customers discussing renewing our long-term contracts for vials starting from 2025. This is the reason why we believe that this temporary destocking, which was more pronounced than previously expected, is going to be resolved by the end of 2024.

The next question is from Paul Knight with KeyBanc.

First question is, I would expect that Novo or Catalent's site in Anagni to expand quite a bit. Would you be involved in that because you're so nearby in Latina? Have you historically been a provider for that site in that region?

Yes, Paul, thank you for the question. Obviously, we can reiterate that our CapEx decisions and plans are not related to a single customer, that we are addressing mostly the biologics space, where there is good growth due to the success of some treatments. We cannot comment, obviously, in terms of any relationship we have with single customers. But we can confirm also that the view about the utilization of our new investment is very clear, and our capacity is almost taken for very precise ideas. In terms of the investment, it will give us the possibility to have more high-value solutions, both in syringes and, even more importantly, the growth in the EZ-fill cartridges that is much more than expected at the time of our IPO, to be candid.

Yes. And then, the single customer delay, is it a delay in clinical trial success? Is it a delay in their other CapEx that they're adding? Could you give a little color on what's behind this one customer delay?

As far as our understanding, it is a change in their planning for the commercialization of some drugs in the biological space that we are involved in with our high-value solutions. We are not talking about any cancellation of committed orders. We are just talking about a change in our forecast, mostly in timing. So we expect to have some news in the near future with the customer. We continue to monitor the situation with them. In the meantime, obviously, we will have time to backfill the capacity to expand our business following other opportunities.

Can I squeeze in a last one? What's your capacity utilization rate right now, Franco?

That is strongly dependent on product line by product line. Obviously, it's clear that it is not the best in vials, but we are under pressure to continue to serve our customers with the syringes with all the most innovative solutions we are bringing to the market. So the rate of utilization is either good or beyond the good standards that we expect.

The next question is from Patrick Donnelly with Citi.

Maybe just a follow-up on that large customer postponement. Can you talk about, I guess, the visibility into this order? Is there any chance it materializes this year? It doesn't sound like it. And if not, does that show up next year? Could that actually lead to '25 growth above trend? Just how do you think about that order and when it shows up and what it means for numbers?

As we embedded in our guidance, we don't expect a significant recovery for the same volume this year. We are talking about high-value solutions, mostly syringes. So we expect to follow the trend of growth in this space, not only because of this single opportunity, but for many others. The time to react in this specific case is also impacted by the longer lead time to start a different production because we have to order the proper components, the proper tubing and then to plan the production, execute production, including the final sterilization. So it's a matter of time more than of the visibility opportunity. Timing of execution cannot allow us to react in a very, very short time.

Okay. That's helpful. And then, Marco, maybe just in terms of the cadence of the year, can you help us think about Q2, what that looks like? And just trying to figure out that second half ramp and how to get comfortable with it. So again, if there's any way you can kind of frame up the Q2 numbers, that would be certainly helpful.

Yes. We expect revenue to increase gradually from quarter to quarter throughout the year. We still believe that the second half of 2024 will be stronger than the first half because the challenges we discussed today are likely to continue into the second quarter. We anticipate that the second quarter will be mostly in line with the previous year, showing growth compared to the first quarter, but not compared to the same period last year; it will be largely similar. For the year, we expect the BDS Segment to achieve mid-single-digit to high-single-digit growth, driven by strong demand for syringes. In the first quarter, we managed to offset a 43% decline in vials with the growth of syringes, which is in line with our expectations. Our current model projects a mid-single-digit decline in the Engineering business for the year, so this is the information we can share today based on our current visibility and the fact that we are increasing our syringe production capacity throughout the year.

No, that's helpful. I appreciate it.

The next question is from Matt Larew with William Blair.

Sam Martin on for William Blair on behalf of Matt Larew. So when I think about the large customer delaying an order, is there any way you can somewhat quantify the impact that had on the reduction to the guide? And then, when we think about destocking accelerating or really even spreading to EZ-fill vials, can you speak about when you first noticed that? You held your Q1 call, I think, in early March. And then, can you speak to really when you noticed it spreading to EZ-fill vials or accelerating past your expectations?

Yes. Our guidance is assuming now a gap compared to prior guidance of approximately EUR 55 million. About the gap, about 65% of the gap is related to vials with a more pronounced gap on EZ-fill vials in this period of time. The remaining 25% is associated with the large order we were mentioning, and 10% is related to Engineering. So this is the breakdown of the delta we assume today based on, again, the visibility we have and the reviewed guidance for those three reasons.

And Sam, I apologize. Can you please repeat your second question? We missed that.

When did you first notice that destocking in vials was accelerating toward EZ-fill? Was it late March or did it become apparent over the course of April? When did it start to become clear that the level of destocking would be worse and more significant than you initially expected?

Basically, two months ago, we were assuming a situation similar to Q4 and the beginning of the year. In reality, in Q1, revenues and orders went down more than our expectation. And we don't have today a clear signal of a different situation in the following quarters throughout the year. So we are taking an approach with vials in line with the new situation compared to Q4 and the beginning of the year. To give you even more color, we went down quite significantly in 2023 in vials. We did not expect such a strong headwind to further decline the level of market demand in 2024. That is what we are incorporating into our guidance for the rest of the year.

The next question is from Remmers Tucker with Jefferies.

Can you guys hear me alright?

Tucker, yes, we can hear you.

Great. My first question is about margin impacts. Can you clarify the contributions from mix and lower absorption? You mentioned a 15% growth in EPS, which seems like it would indicate a positive effect from the mix, but we didn't really observe that. Could you provide a breakdown of the mix and absorption factors affecting the margin?

Yes, of course. I'll start with the mix. First of all, it's good. We are shifting syringes more and more toward high-value products. This is the main driver for increasing the share of high-value products. Within high-value products, on the other side, we are, as you know, market leader in sterile vials, and this is a very accretive product for us. The sharp decline in EZ-fill vials is what impacted the most the margin, so a mix effect within the mix of high-value products. Second reason is, as mentioned, the underutilization we have in bulk vials lines, mainly because this is where we have more quantity and fixed cost compared to the other lines. And so, the impact has been significant also there. In the first quarter, we had higher depreciation, as you can see from the numbers in the range of 150 basis points more. So, the combination of these factors will more than offset the mix shift toward high-value products in general.

Got you. And if I can get one more in, so what were the temporary inefficiencies in Italy, in particular, but kind of in both Fishers and Italy?

Yes, it's more in Italy, of course, because today, the most important factory for EZ-fill is still in Italy. Obviously, Fishers, we are in a ramp-up phase. But yes, the short answer is yes.

The next question is from Larry Solow with CJS Securities.

This is Will on for Larry Solow. I understand today's revision is related to a temporary slowdown in market and widespread inventory destocking. But can you update us on the competitive environment in ready-to-use products?

Yes. To begin with vials, we continue to hold our leadership position in ready-to-use vials. Our outlook regarding capacity expansion for ready-to-use vials in the mid to long term remains the same. It requires time since we are transitioning the market from vial configuration to ready-to-use configuration. Therefore, we prioritize the mid to long term over a single quarter or year’s volume. However, the trend toward adopting ready-to-use configurations, not just in vials but also in cartridges, is very crucial for us.

Alright. Great. And then, just one more. There's a lot of talk of tightening regulations on drug packaging quality and adoption of high-value solutions and services for not only new drugs but the conversion of older legacy pharmaceuticals. Have you seen increased customer interest on this front?

Yes, sure. There are some regulations that are becoming stricter and stricter. I can mention Annex I that are pushing customers to adopt stricter rules about particle contamination. Ready-to-use vials and cartridges are the right answer to these needs in the current configuration and even more when we will have the commercial volume for the new generation of the same products. So it's one of the most important drivers for the adoption for sure, that is on top of the other benefits we deliver to customers in terms of total cost of ownership reduction and flexibility. That is something that is very important for our customers.

And just to add one comment on that, as we discussed at our Capital Markets Day, we are seeing this adoption, and we can see it in the infrastructure and the industry, particularly as it relates to fill and finish lines capable of processing ready-to-use containers. So we see that as an important leading indicator as well as Annex I that will further enable that adoption as we move forward.

The next question is from Curtis Moiles with BNP Paribas Exane.

So you, in the BDS Segment, had commented that you're seeing strong demand for syringes. I just wanted to check, can you give a little bit of color around the demand that you're seeing for the cartridges as well?

You know that we are a market leader in cartridges since many years because the cartridges are the containment solution for pen injectors. So the growth of, generally speaking, the self-administration and even more the expected growth in pen injectors is driving volume for the future. In this space, the adoption of higher-quality standards and the protection of quality that is more pronounced when they use ready-to-use configuration is accelerating the demand for such containment solutions in the market. So our CapEx is really in line with these trends, and we expect to take opportunities mostly in biologics because of the quality of our containment solution and because of our ability to serve them in ready-to-use configuration. That is also linked to the positive impact in the business we have from the same trends in Engineering for our assembly lines and visual inspection systems.

And if I could just add another one on the Engineering Segment, you had previously mentioned that there were long lead times for electronic components. I'm just curious, have you seen any improvement there? Or do you have a timeline of when that will be kind of normalized?

The comments I made before were mostly related to what happened in 2022. Now the situation is much more normalized in terms of reliability of the supply. There are still lead times that are longer than five years ago. What is now needed to be ordered two months in advance, a few years ago was out-of-the-shelf supply. But now we have adjusted our planning to the new situation. And so, we are dealing with the tail of what happened one year ago or more.

Ms. Miles, gentlemen, there are no more questions at this time. The floor is returned to management for any closing remarks.

Thank you. Franco Stevanato will add some closing remarks.

Thank you, Lisa. So despite this near-term headwind that we are facing in 2024 for vials, that is more pronounced than what was expected, what for me is extremely important to reassure all of you that our strategy is extremely solid. We are confident in our future. We are so proud and honored to invest in these new greenfield plants because we are behind big customer programs, in particular for syringes, Nexa, and EZ-fill cartridges, and we are today laser-focused to execute. Nothing changed on our strategy to deliver to our customers a high-value solution program for them. So today, the organization in a humble approach is going to more and more reinforce attention on execution and efficiency in order to deliver what we presented during the Capital Market Day in New York. Thank you.

Ladies and gentlemen, thank you for joining. The conference is now over. You may disconnect your telephones.