Hello and welcome to today's Stevanato full-year results. My name is Elliott and I'll be coordinating your call today. [Operator Instructions]. I would now like to hand over to our host, Lisa Miles, Head of Investor Relations. Please go ahead.

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. I'd like to remind everyone that a number of statements being made today will be forward-looking in nature. Please remember that such statements 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 annual report on Form 20-F for the fiscal year ended December 31, 2021 filed with the SEC. We encourage you to review the information contained in our earnings release today in conjunction with our associated SEC filings. 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 presented in this document, please see the company's most recent quarterly earnings press release. And with that, I'll hand the call over to Franco Stevanato for opening remarks.

Thank you, Lisa. 2021 was a landmark year for Stevanato Group underscored by the power of our integrated capability and value proposition. For 2021, compared to the prior year, we deliver double-digit revenue growth excluding COVID, expanding margins and increasing mix of high value solutions as raising customer demand was matched with a first rate execution. With the successful IPO behind us, we met or exceeded our full-year 2021 financial performance metric despite the complexity of the current global supply chain environment. We finished 2021 with a solid backlog and new order intake as well as a robust pipeline of new opportunity. At year-end, Stevanato had more than €400 million in cash, a flexible balance sheet and ample liquidity to fund future investment in growth platform. The recently announced investment from BARDA illustrate our strong reputation and further confirm our strategic approach in the US to invest and broaden our offering in this strategic region. Our three-year track record demonstrates consistent delivery in our financial and operational objective. Today, the fundamental of our business continues to strengthen as we steadily advance our strategic priority to capitalize on strong customer demand. Amid favorable macro trend, our integrated capability resonated with customers as we aim to drive double-digit revenue growth, increase our mix of high value solutions, expand margins and deliver long-term shareholder value.

Thank you, Franco. Our successful financial and operational performance in 2021 sets the foundation for sustainable organic growth. For the full-year 2021, revenue grew 27.45% over the last year, driven by growth in both segments and an increasing mix of high value solutions. We closed the fourth quarter of 2021 with new order intake of approximately €278.3 million and a committed backlog of approximately €880 million. We view these key performance indicators as important measure for our future growth prospects and represent and represent ongoing favorable customer demand trends as new treatments come to market to tackle chronic diseases and advance patient care. Turning to slide 6. Revenue from High Value Solutions was strong in the fourth quarter, which helped boost the full-year mix to 25% of 2021 revenue compared to 22% last year. We expect this trend to continue as customer choose the ready to use platform because they reduce customers' total cost of ownership, get treatment to market faster and increase quality and flexibility. In 2021, we experienced rising demand for syringes compared to last year. The increase was driven by our high performance, ready-to-use syringes platform where orders doubled in 2021 compared to the prior year. These proprietary platforms include our Alba and Nexa syringe products that are gaining traction. This platform ideally suited for biologic and high-sensitive drugs, like monoclonal antibodies, mRNA vaccines, and recombinant proteins because of their advanced technology and the superior performance. We expect this trend will continue into 2022. The evolution in our High Value Solution extends beyond the primary packaging. We continue to expand our integrated capabilities in the drug delivery space of pen injectors, auto injectors, and wearable pods. In January 2022, we expanded our agreement with Haselmeier for our proprietary Alina pen injector, granting us exclusivity to support a…

Thanks, Franco. We are very pleased to deliver another solid quarter of financial results, which helped top our full-year estimates. For the fourth quarter of 202, revenue was better than expected and grew 12.5% to €232.6 million over the prior year. This was driven by another strong quarter from our Engineering segment due in part to the ongoing capital deployment by customers to satisfy industry demand. For the fourth quarter, COVID represented approximately 14.3% of revenue. As we mentioned on our last earnings call, the fourth quarter of 2020 included a benefit of approximately €15 million in our BDS segment related to the timing of our revenue, which concentrated the revenue recognition in the fourth quarter, but had no impact in full year 2020 revenue. For the full year, revenue increased 27.5% to €843.9 million over last year, driven by growth in both segments. As expected, COVID represented approximately 14.7% of revenue for fiscal year 2021. Excluding COVID, revenue grew approximately 15.2% over year 2020. Please turn to slide 12. As expected, contribution from High Value Solutions increased approximately 62.9% to €66.4 million in the fourth quarter compared to last year, representing approximately 28.5% of consolidated revenue. For the full year, High Value Solution grew approximately 42% over last year to reach €207.8 million, bringing the full-year mix to approximately 24.6% of consolidated revenue. And while investors should anticipate quarterly fluctuations, our long-term trajectory remains unchanged, with a target mix of mid-30% by 2026, contributed to the expansion of EBITDA margin over the long term. Moving to slide 13. The increase in more accretive High Value Solutions and ongoing operating efficiency gained from our Lean manufacturing initiatives contributed to increased gross profit and operating profit margins. For the fourth quarter, gross profit margin increased by 310 basis points to 31.4%,…

Thanks, Marco. Our 2022 guidance reinforces our belief that we can continue to deliver on our long-term objectives. We have earned a reputation as a leader in premium drug packaging and engineering, serving as a vital lead to the safety and effective administration of our customers' injectable treatments, diagnostic tests and therapies. We have a relentless focus on driving constant innovation R&D, delivering high quality products, offering scientific and technical support and meeting market demands. We serve some of the fastest growing market segments and we are integrated into the drug production and delivery supply chain, with favorable multi-year secular tailwinds, including pharmaceutical innovation, aging population with chronic conditions, growth in biologics and biosimilars, acceleration and expansion of vaccination programs, self-administration of medicine, an increase in quality standards and regulation. Above all, we believe that our strong reputation, coupled with these favorable macro trends and our high quality suite of products, position us well to benefit from continued demand, and in turn, deliver double-digit revenue growth, margin expansion and long-term shareholder value. Operator. Let's open up to the line for question.

[Operator Instructions]. Our first question today comes from David Windley from Jefferies.

I want to start with just a couple of kind of housekeeping type questions. Marco, I was hoping you could tell us what the dollar value or the percentage of revenue from your EZ fill products that you're not including in High Value Solutions.

We are going after rapidly in EZ fill. As our practice, we provide that at both segments and High Value Solution. Anyhow, I can tell you that High Value Solution went up 42% in the year. And EZ fill sales went up more or less in the same range year-over-year.

Secondly, you mentioned the inflation factors and the pricing that you're taking, watching supply chain, things of that sort. Can you quantify any kind of unexpected negative impact that the fourth quarter P&L absorbed? Maybe talk about the timing of the pricing? Is there any lag between the pickup on pricing versus the costs that you're incurring?

Yes. As anybody else in the industry, we are facing inflation pressure, like any other industry. We have experienced, we mentioned in Q3, some logistical cost increase. We have put in our models some other cost increase in our total manufacturing cost. And as Franco was saying, we are recalculating price frequently and rising price accordingly. Overall, we expect also taking out the inflation from our model and organic double-digit growth for 2022 compared to 2021.

The last question I have is around your capacity. You mentioned the shift in some of your CapEx spend. And I guess, first of all, I want to just confirm that that's not impacting the timing of capacity that you're bringing on. And then, kind of maybe flipping the coin and asking the question the opposite way, does the BARDA investment give you any ability to accelerate the pace of buildout and validation of your Indiana greenfield?

Starting from the third part of your question about the capacity. Since we have our original plan for capacity expansion, the demand grew more than expected. So, we took the decision to boost the capacity in Italy. That is the way we can bridge waiting for the availability of new capacity in USA and China. And our modular approach to investment make the possibility to be reactive and responsive to match the upside in demand. Back to the second part of your question about BARDA. The BARDA agreement involves a multi-year plan to expand the capacity. For sure, it is a sort of acceleration of part of our initial plan, but is not for the short time.

Our next question comes from Paul Knight from KeyBanc.

Could you update us on the planning on the China expansion as well?

Yes. Our plans are not changed at all. We are proceeding. As we mentioned, we spent some time to improve, to optimize the capital allocation, also to work on having the right appropriate financial incentives, but we are in line both with designing and starting construction and hiring people, training people to get ready for the data. We already mentioned that this is happening in the first activities and the first revenues in first half and second half of 2024.

It looks like COVID and non-COVID grew a little better than expected. Is the industry moving to lower doses per vial with COVID at this point, do you think?

There is a continuation of this trend to move from multi-dose to single dose that impacts the volume needed for the market, both in syringe and vial. We see opportunities in both areas because you are well aware that we produce both the syringe and vial. Our syringe is proven to be the right solution also in terms of suitability with cold chain distribution. So, we monitor these trends and there is no impact in our planning about the capacity expansion. Our next question comes from Derik De Bruin from Bank of America.

One housekeeping question, what's embedded in your guidance for FX in the top line?

Derek, let me just clarify. You're wondering what the currency translation rates are that are embedded in our guidance?

What should we model for currency headwinds? The question about what's the organic revenue growth guide before – the total bit.

We don't expect material changes compared to 2021 in our model.

When you look at your business, the COVID expectations you're guiding to are basically in line with where we are. I guess the question I have is, like, if you weren't doing COVID work, would your non-core business be even higher? That is, are you turning away business or delaying business due to having to do COVID work? It's basically trying to get to sort of like what's the underlying core demand?

As we several times mentioned, our business is not COVID dependent and the visibility we have a because of the backlog interaction with customer make us in good position to look after the order intake. And we have good visibility in COVID revenue that we think – and we believe will remain consistent also in the near term. It's harder to speculate about the future of the COVID. But we feel reasonably confident that we can match any possible free capacity with fresh order because the demand is very strong in different therapeutic areas.

And just to complement, we mentioned the fact that the visibility in our revenue in form of backlog for 75% of 2022 midpoint guidance. So, again, we have clear visibility also about COVID for 2022. And as Franco was saying, it's obviously more difficult to speculate for 2023 and beyond.

Just one final question, High Value Solutions at 25% exiting fiscal 2021, the mid-30s by 2026. How should we think about that number for 2022? Basically, I know it's not going to be linear, but should we think about another two to three percentage point increase on average per year?

As you noticed, we were in 17% range in 2019, 22% to 2020, and we are close to 25% in 2021. We see the trajectory going on. We have a robust backlog and visibility. And we see high 20% range for 2022, consistent with our trajectory and expectation to meet 30% by 2026.

Our next question comes from Lizzie Speyer from Citi.

I'm on for Patrick. I think backlog, as you touched on earlier, ramped to €880 million this year. Can you just talk more about how that 75% for 2022 that's covered compares to prior years?

The backlog is much stronger this year compared to 12 months ago where we had approximately €600 million backlog. So, we have much more visibility this year compared to 12 months ago. We see robust backlog in both segments. The percentage is more or less the same in the two segments. So, we have clear visibility and ability to plan in advance.

I guess, just broadly, can you talk about how you guys performed in the three regions between Europe, US and APAC and what your outlook is for these regions and going into 2022?

Both regions, we have grown in Asia-Pacific, particularly, as you have seen, in 2021. We expect robust growth both in Asia-Pacific and North America regions for 2022. Europe is still a very important market for us, but we see growing more those in those regions than Europe.

Our next question comes from Tim Daley from Wells Fargo.

My first question is, digging a bit more into the booking trends and the backlog, how should we be thinking about, I guess, these lead times and the percent of revenues that are captured in backlog heading into the year as we go forward? Are you expecting some sort of normalization in lead times? Any sort of detail you can provide around what happens when, I guess, things start normalizing a bit more and how should we think about the trajectory of backlog and book-to-bills and everything throughout 2022?

In a way, we experienced, as mentioned a couple of times, our customers are booking in advance capacity to secure their supply chain. And this is one of the reasons why we have been able to grow the backlog so significantly beside growing over Stevanato Group business. It's not easy to speculate what's really going to happen in the future. But we see, as Franco was saying, very robust demand in the market, so we are not worried about filling our capacity for the future.

In a similar vein there, I know you noted that 75% of the sales for 2022 are captured in backlog. For the around €140 million or so of COVID works expected per year guidance here, how much of that is captured in the backlog? Or are there any assumptions baked into that €140 million number?

Yeah, more or less the same percentage. The 75% of coverage.

My final one is on margin. So, obviously, lots of noise going on in the macro front, especially in Europe around energy prices. What are the assumptions baked into the EBITDA guidance for, I guess, energy prices, how much of your expenses this year were spent on energy? And do you have any hedging mechanisms in place to account for the macro volatility going around right now?

Those are the costs we are talking about when we say we are frequently recalculating our total manufacturing cost. Again, this is a situation everybody are facing in any industry. Our customers understand it. Obviously, we try to minimize the cost increase, but we are increasing our price accordingly.

Tim, just to follow up on that, as Marco mentioned previously, if you exclude the cost increases year to year, we still anticipate double-digit organic growth.

Are there any hedging mechanisms in place for energy costs?

There is no mechanism. It's not the clauses that are embedded generally in our agreement with the customer, but the relationship with the customer allows us also to share the situation and we think they can really understand what is going on in the market.

And you probably know an important part of our production is in Italy where we have some protection due to the long-term agreement we have with utilities here in Italy.

Our next question comes from Drew Ranieri from Morgan Stanley.

Just on guidance for a moment, you grew 15% ex-COVID in 2021. 2022 looks like it's taking a little step down. Is this just modeling conservatism into your guidance? Or just as you're kind of looking at the business, can you talk about maybe areas of the business where you are starting to see any type of slower growth rate relative to 2021? And then, just on your commentary about phasing between the back half and first half the year, can you give us a little bit more detail there on how the businesses should ramp over the year?

For 2022, as mentioned, we expect strong sales in second half of the year compared to the first half of the year because of the capital deployment we are doing, increasing capacity mainly in EZ fill High Value Solutions. We can tell you also that we expect double-digit growth in our BDS segment, boosted by High Value Solutions. In Engineering, we are initially modeling a nice single-digit growth compared to 2021 when we went up almost 55%.

On the inflationary environment, you touched on this a little bit, but should we think gross margins will be able to actually expand in 2022? Or should we kind of think about it more consistent with your 2021 levels or will High Value Solutions really drive the mix shift and you'll see some pricing benefits? Just trying to get a better sense of gross margin expansion here.

But I think [indiscernible] grow back to the driver of our growth that is the market. The market demand is growing very fast. And the demand for our High Value Solution is very strong, particularly in syringes with our Alba and Nexa products, EZ fill vials also enjoy very robust demand. So, this is the main driver. And we are growing because we are putting our investment in that direction, deploying the capital step by step to increase the share of High Value Solutions in our portfolio. So, [indiscernible] it is the result of these efforts coming from the demand on the market.

Just lastly, just on COVID related revenue, is there any way to put out a 2023 number of kind of what you're thinking about for potential COVID contribution?

There are many variables playing in the foreground for 2023. We mentioned that they shifted from multidose to single dose [indiscernible] that could be from neutral to favorable from the economic point of view. We cannot speculate on the presence of new variants, and there are many, many factors understood before providing any numbers on 2023.

Our next question comes from John Sourbeer from UBS.

I guess any update around new customers in the quarter with HVS growing pretty solid 63% roughly year-over-year. I guess, specifically, what percentage of that HVS growth was from new customers?

We will not disclose these figures. But what I can say is that there is a very huge demand for High Value Solution linked to new therapeutic and new drugs, specifically in biotech space. So, this is one of the main driver of our emerging business in that space.

John, just as a reminder, many of our contracts with our customers are under nondisclosure agreements. And so, therefore, that would be the type of information that we won't be able to provide on a regular basis.

I guess just as a follow-up, the comments in 1Q with the increased absenteeism in January in Europe due to the Omicron spike, any way to quantify the impact there, just how we should see on the cadence on 1Q for the guidance?

When Omicron variant hit Europe, also we had to face an increased rate of absenteeism in our facility in Europe, and we took countermeasure in terms of having more shifts from people that were happy and with the incentive to have people at work. We are not going to quantify the impact. But what I can say is that mid to late February, we came back to the normalized condition in term of staffing, in term of productivity, and we expect to continue this direction.

Our guidance includes this headwind.

Our final question comes from John Kreger from William Blair.

Maybe just one more to try to clarify in the first quarter outlook. Do you expect revenue growth to be positive in the first quarter compared to last year? Should we assume down a bit given the Omicron surge?

We expect significant growth to produce earnings in the range of double-digit growth.

Marco, is that in the first quarter or is that for the full year?

First quarter, we expect lower revenues than in Q4 in both segments, but nevertheless, we expect inorganic growth double-digit year-over-year.

Another question. Sounds like you've had strong orders. Are you capacity constrained at all? In other words, how does your time to complete orders now compare to where it was, let's say, a year ago?

First of all, the demand for our High Value Solution remains very, very strong. So, our plan to expand the capacity, the space is obviously something that is vital. We recognize that the execution is a vital factor to match the customer expectation and we will continue to put the best effort to match their needs in the shortest time possible.

One last one. You noted CapEx is supposed to be much higher in 2022. I understand part of that is a push from 2021. Can you remind us what you think your longer-term CapEx spending ratio should be relative to revenues?

2022 is expected to be the peak year for CapEx because of the initiative we launched. We expect also high CapEx in 2023 as we completed the buildings and the machinery for US, Europe and China. As normalized CapEx, we see for the future something in the range of 9% of revenue to keep on growing double-digit. We can expect some year where we are installing more capacity followed by years when we leverage the existing capacity and just concentrate on driving execution. But this is what we have in mind. The medium term is normalized level of CapEx.

We've come to the end of our Q&A. I will now hand back to the Stevanato management team for closing remarks.

We want to thank everyone for joining us today for the Stevanato Group fourth quarter and full-year 2021 earnings call. We appreciate your time and have a good day. Bye.

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