Stevanato Group SpA

NYSE:STVN

Earnings Call Transcript 2021-Q2

[Lisa Miles, Head, IR]

Good morning and thank you for joining us.

With me today to offer prepared remarks is Franco Stevanato, Executive Chairman; Franco Moro, Chief Executive Officer and Chief Operating Officer; and Marco Dal Lago, Chief Financial Officer. We are also joined by Mauro Stocchi, Chief Business Officer; and Paolo Patri, Chief Technology 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 our registration statement on Form F-1, which was filed with the Securities and Exchange Commission on July 16, 2021. We encourage you to review the information contained in our earnings release today in conjunction with our associated SEC filings and F-1. 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.

[Franco Stevanato, Executive Chairman]

Thank you, Lisa. Good morning and thank you for joining us. Today, I’m going to kick off with some key highlights at the investment consideration for Stevanato Group.

First, I’m pleased with our financial results for second quarter and first half of fiscal year 2021. Revenue for the first half of 2021 grew 33% and adjusted EBITDA increased 58% over the same period of the last year.

Our operating performance reflects our long history of more than 70 years serving the pharma, biotech and life science industry. The core of our DNA is science and technology. Our unique analytics and engineering capability have helped solidify our position as the market leader worldwide in pen cartridges and EZ-Fill vials. We serve the top of blue-chip, global, high-growth biopharma, pharma and diagnostic customers. We have a strong track record for customer support and service, which has translated into customer retention rate of 97%.

Over the last 70 years, we have grown the business through constant investment in technical and scientific innovation, geographical expansion to better serve our customers and solidify our position in the pharmaceutical value chain. The proceeds from our recent IPO will be invested to drive sustainable long-term organic growth.

Our top three investment priorities are: one, geographical expansion; two, research and development to sustain and accelerate our high-value solution; and three, selected M&A, which are the same fundamental goal of creating and driving long-term shareholder value.

On behalf of the Board, we are proud of the positive steps the management team has taken to advance the Company position in the market and we are confident in their ability to execute against the Company’s long-term strategic plan. Franco, Marco, Mauro and Paolo bring deep expertise, decade of experience and an unparalleled commitment to achieving our growth objectives. We believe we have the right team in place to drive vision and strategic pillars over the next 10 years.

The family, the Board and the management team are keenly aligned with the goal of building long-term shareholder value. Our mission is simple, delivering patient-centric solutions to support our customer need to meet the increasing market demand, driven by positive macro environment. Stevanato Group remains at the heart of the pharmaceutical value chain now and for decades to come.

And with that, I will hand the call over to Franco Moro, Chief Executive Officer.

[Franco Moro, CEO and COO]

Thanks, Franco, and good morning.

For the second quarter, we delivered solid year-over-year operating and financial results, highlighted by double-digit revenue growth. More importantly, the key performance indicators of future growth came in particularly strong. We continue to make a steady progress in transitioning our revenue to an increasing mix of high-value solutions, which accounted for 24% of total revenue in the second quarter. Our high-value solution includes our higher-margin products focused on pre-sterilized vials, cartridges and syringes. The solution offers an increasing value to our customers with four key advantages, reduced time to market, lower total cost of ownership, increased quality and improved flexibility. Our focus and much of our future investment will be dedicated to growing the mix of high-value solutions.

The second quarter was also highlighted by strong order intake. We handled the second quarter with the new order intake of €278 million and a total backlog of €739 million at June 30. We define our backlog as customer-committed orders. The current backlog provides significant visibility into future revenues. This gives us confidence in our ability to achieve our revenue guidance for 2021.

We are pleased with the positive momentum in new order intake and backlog. These are indicative of the positive favorable trends in the market today. This trend has paved the way for our consistent double-digit growth over the last 10 years. And today, we are focused on executing against our strategic investment plan to take advantage of the longer term demand.

So today, I want to talk about our expansion and investment framework. This is an important element to driving sustainable, accretive growth in the near term and the long term. With that in mind, I will provide context around our historical investment strategy, how that translated to growth and our plan to replicate this strategy in the years ahead.

In 2016, we launched expansion initiative that has been yielding double-digit growth over the last few years and continue today. We accelerated our investment in Italy and abroad, which served as the catalyst to meet the significant increase in demand precipitated by COVID. Yet at the same time, we are still able to significantly increase production in other core products outside the vaccine space, particularly in vials and cartridges. For example, our investment also allowed us to remain number one in the insulin pen cartridge market.

I will highlight key methods and capacity increases tied to this effort. First, in our EZ-Fill pre-fillable sterile syringes. When compared to our production output in 2016, we expect to double the number of syringes produced in 2021 and up to triple the syringe output in 2023.

Secondly, in our EZ-Fill sterile vials and cartridges, the numbers are even more impressive. In 2021, we expect to produce up to 11 times more sterile vials and cartridges compared to 2016. And in 2023, we expect to produce up to 19 times sterile vial and cartridges compared to 2016.

Our investment initiatives are targeted to the production delivery or more accretive high-value solutions. Equally important, this is in direct response to customer demand. The approximate CapEx on the EZ-Fill expansion between 2016 and 2021 was roughly €220 million, and we will continue investing.

The recent acceleration of organic growth demonstrates our proven track record in optimizing our capital investments. At this stage of our life cycle, we see unprecedented demand. In the near term, we have made timely investments in our capacity to enable us to stay ahead of our customers’ rising demand for our high-value solutions, and we expect to invest in a similar manner in the future. We are supplementing our ongoing expansion with a new EZ-Fill line and converting space to dedicate to our high-value solutions.

An important element to our investment strategy is anticipating customer demand to make the right investment at the right time. This has been our approach in the past and it continues today. Based on current trends, we believe now is the time for investing in expanded capacity globally for our EZ-Fill solution.

Our current expansion plans in the U.S. and China are proactively addressing where we believe we will continue to experience high levels of customer demand. Our future investments in the fastest-growing market of the U.S. and China advance our position with customers across the pharmaceutical, biotech and life sciences industries.

From a CapEx perspective, we currently plan to spend approximately €300 million for our plants in the U.S. and China. This will expand our existing footprint in the geographies and enhance our proximity to customers in attractive end markets.

As many of you already know, the U.S. market is highly sophisticated, and the pace of growth in biologics is at record speed. We believe that we are well-positioned to become a larger player in the market.

From a timing perspective, we expect to break ground in Indiana in the fall of 2021. We anticipate construction will take approximately 18 months, followed by startup and customer validation in 2023. At this pace, we are currently targeting a revenue generation to begin around the end of 2023 or early 2024.

In China, the backdrop is very different. There is a predominance in biosimilars, and the biologics market is just emerging. Our goal is to take advantage of market timing to be among the first movers. We are estimating that construction will begin in early 2022, which puts our estimated revenue generation in the second half of 2024.

We are approaching these new investments with the ambition to replicate this strategy, discipline and execution as with past investments. Our overall approach of increasing capacity, embedding a scientific technological advancement in our portfolio and broadening our servicing and geographical reach is the cornerstone of driving value to our customers.

We are also boosting our efforts in research and development with a significant emphasis in service capabilities. These investments are evident in our technology centers in Boston and Italy. The scientific analytical services developed in our technology centers are helping us gain an early entry point with our customers. We expect this will help expand our presence in the pipeline of new biologic drugs. In parallel, these efforts are aimed at expanding our own portfolio of proprietary solutions across all product lines.

Above all, we believe that the current underlying trends and the macro environment set the stage for favorable tailwinds for decades to come. We currently see a confluence of events coming together, with an urgent need to tackle the challenge of aging population, the increasing complexity in health condition and comorbidity rates, and the significant shift in patients seeking to manage their conditions and access care closer to their home environment. We believe we are well-positioned to capitalize on these trends. Our priority is to support our customers in creating and delivering patient-centric solution, which is central to our philosophy and vision.

I will hand the call over to Marco to cover the financials in more detail.

[Marco Dal Lago, CFO]

Thanks, Franco.

For the second quarter, total company revenue grew 26% to €204 million and 28.5% on a constant currency basis compared to the same period last year. Top line increases were driven by growth in both segments and all geographies.

As Franco noted, our focus remains on expanding the sales mix of our high-value solution in the portfolio. For the second quarter, high-value solutions accounted for approximately 24% of total company revenue. We currently expect full-year contribution from high-value solutions to range between 25% and 26%.

The COVID-19 pandemic continues to be a tailwind and has increased demand for our drug containment solutions. We are playing a meaningful role in the fight against pandemic. And our products are supporting the vaccination rollout around the world. In the second quarter, we estimate that approximately 15% of gross revenue was linked to the pandemic.

The key takeaway is that excluding COVID, we still achieved a robust double-digit growth in the second quarter compared to last year. This is a result of solid demand for our core products and the shift to high-value solutions. For the rest of the year, we expect contribution from the pandemic to remain consistent. We currently estimate that gross revenue attributable to COVID will range between approximately 13% and 17% for 2021.

For the second quarter, total company gross margin improved 100 basis points over the last year to 31.2%, mainly thanks to our focus on high-value solutions.

Also, in the second quarter, adjusted operating profit margin improved 240 basis points to 19.1% and adjusted EBITDA grew by 90 basis points to 25.7%. It was due to gross margin expansion and efficient cost management and certain overhead expenses. In parallel, we continue to increase investment in R&D activities compared to the same period last year as we aim to sustain and accelerate the pipeline of high-value solutions.

Operating profit of €47.6 million and EBIT of €61 million include a onetime benefit of €8.6 million gross profit, which is €4.4 million of net profit or €0.02 of diluted earnings per share. The majority of this is related to the termination of a stock incentive plan. As a result, second quarter diluted earnings per share was €0.14 and adjusted diluted earnings per share were €0.12.

Moving on the segment results, starting with BDS segment. Second quarter revenue increased 23% in our Biopharmaceutical and Diagnostic Solutions segment compared to prior year, despite unfavorable foreign currency translation. On a constant currency basis, year-over-year revenue growth was 26%. This segment benefited from revenue increase of 27% in high-value solutions and 21% in our containment and delivery solutions over the same period last year.

Second quarter gross margin and operating margin improved compared to 2020, principally due to an increase in more accretive high-value solution and improved efficiencies.

For the second quarter, revenue derived from third parties in the Engineering Segment grew by 50% to €29.1 million over last year. This segment experienced growth across all business lines, including visual inspection machines, assembly and packaging systems and glass converting machines.

Margin expansion in the quarter compared to the prior year period was driven by an increase in after-sales activities to support customers and improve synergies across our manufacturing network.

Moving on to balance sheet and cash flow items. We ended the quarter in a solid financial position. At June 30, 2021, cash and cash equivalents totaled €100.8 million. For the second quarter, cash from operating activities increased to €54.1 million. We continue to prioritize investment in our future growth. And as such, capital expenditures totaled €23.7 million during the quarter. Free cash flow in the second quarter was €31.3 million.

At June 30, our net debt ratio improved to 1 compared to 1.3 at the end of March 2021. Our leverage between net debt and trailing 12 months EBITDA had improved to 1 compared to 1.4 at the end of 2020. We define net debt as current and non-current financial liabilities, minus other current financial assets, financial receivables, and cash and cash equivalents.

In a nutshell, we believe that our cash, future cash generation from operating activities, availability under our existing debt facilities and the proceeds from the IPO will be adequate to address our future liquidity needs.

In terms of capital allocation strategy, our approach remains measured and disciplined. To recap, our top three priorities are: first, much needed expansion to increase capacity, especially in our high-value solution where demand is high; second, investment in research and development to sustain and accelerate our high-value solutions pipeline and to maintain our market-leading position, offering the highest quality products; and lastly, selective, prudent approach to M&A to complement our existing book of businesses. We view M&A in the construct of driving organic growth. This has been our approach in the past, and it remains the same today. We see no major gaps in our portfolio, but we believe there are markets that are natural extensions of our current core competencies.

And finally, as highlighted in this morning press release, we established full-year 2021 guidance. The Company currently expects revenue in the range of €820 million to €830 million. This will represent a year-over-year growth between 24% and 25%; adjusted diluted earnings per share in the range of €0.43 to €0.47; lastly, adjusted EBITDA in the range of €212 million to €217 million, which will represent a growth between 32% and 35% over the prior year period.

And with that, let’s open it up for questions. Operator?

[Operator]

[Operator Instructions] Our first question comes from Paul Knight from KeyBanc Capital Markets.

[Paul Knight, KeyBanc Capital Markets]

Congratulations on the quarter. The backlog trend looks to be very -- can you talk about the -- was it -- the core business in terms of ex-COVID, can you talk about demand for the high value-add solutions and what -- the color around that backlog?

[Franco Moro, CEO and COO]

Paul, thanks for your question. For sure, the trends that we are facing are very good, and we target to have this very robust backlog and to deploy our capacity accordingly to satisfy our customer demand.

So, in terms of the color about the backlog, we -- when we talk about the backlog, we are talking about committed orders and this visibility allowed us to plan the utilization of our capacity in a very efficient way. Nevertheless, we are also investing to expand the capacity to match additional upside in demand coming from the customers. And in terms of the COVID-related demand we can say that -- for sure, we can state that the current year is impacted by the COVID and we have some visibility for the next year. For the longer term, we envision to have a transition to a normal business in terms of vaccines. And you know that we are a well-established player in the vaccine space since decades.

[Paul Knight, KeyBanc Capital Markets]

Do you have capacity, or is it tight right now of supply customer demand?

[Franco Moro, CEO and COO]

I want to reiterate that the capacity we have for our high-value solutions are the most important asset for the -- also for the future because the COVID situation proved that our high-value solutions are really suitable not only to match their technical specification of drug but also to have a faster response to the upside in demand. And our internal engineering capability is an amazing differentiating factor in terms of the competition because we took to be faster than anybody else to match the demand.

In terms of the constraints that you mentioned, for sure, we have to take care about our CapEx to adjust in advance our capacity to the demand coming from the market, but we are in a very good position and we deploy this capacity -- additional capacity around the world. And we are ready to move also the high-value solution, the EZ-Fill capacity, not only in Europe as we are now, but also in U.S. and China.

[Operator]

Our next question comes from David Windley from Jefferies.

[David Windley, Jefferies]

Hi. Thank you for the results this morning -- or this evening for you. And I appreciate you taking my question. I wondered if you could comment a little bit on kind of borrowing from Paul’s question on how COVID is influencing your high-value solutions sales, is there much overlap there? And kind of how do you expect that to evolve?

[Franco Moro, CEO and COO]

Thank you, David, for the question. So, in this stage, I have to refer to the message that we are not a newcomer in the vaccine space. We are working with the biggest player in the market that is the case. So, we -- thanks to the intimacy with such customers, we can adjust our production for the future.

And in terms of the technicalities linked to our high-value solutions, we proved that the drug containment solutions are the best choice also for amazing request linked, for example, to the COVID chain and the supply chain for vaccine. So, we think that after this year and the next year, the vaccine for COVID that we land at the end in a more or less normal business for vaccine treatment.

[David Windley, Jefferies]

Okay. On your backlog, I don’t believe I have a number for the comparable Q2 of 2020. If you’d be willing to give that, I’d love to get it. But the spirit of the question is that your backlog growth year-over-year is substantial in the first quarter, and then it looks like it’s sequentially double digits from the first quarter of this year to the second quarter. And you’ve already mentioned visibility is quite high. It seems like your visibility to this year’s revenue based on backlog is substantially better than what it probably was last year. And so, I guess, I wanted to understand how conservative your revenue assumptions are for this year and/or how much of that backlog is giving you greater visibility into 2022, if you understand the question, hopefully.

[Franco Moro, CEO and COO]

Yes. I hope we understand your question. I give you the general -- the full picture, and then maybe Marco may comment about the financial.

For sure, the visibility is very high and the demand is very strong. Demand is very strong because the market is growing, and we anticipate some investments to allow us to give the right answer to our customers. Nevertheless, our business has some factor that impacted the time line that is linked to the building the right supply chain with the right level of robustness for us and for our customers, the lead time in production and then all the planning activities that allow us to have a very robust answer to our customer and to meet their expectations. For sure, now it is very easy to say that the coverage for this year is very high, very good. There is the possibility to have an upside. We believe that the guidance we provided are fair, not too prudent, not too aggressive. It is the fair expectation for this year. Marco may have more fully...

[Marco Dal Lago, CFO]

Just to complete the answer, David, last year, same period, we had about €396 million of backlog. As you know, we went up to €605 million at the end of 2020, €665 million at the end of Q1, and we are now at €739 million. So, we have much better visibility, as Franco was saying, between the sales already realized and the expected sales coming from backlog in the second half of the year, we cover by 94%. And we are starting also building the backlog for next year.

[Operator]

Our next question comes from Dan Leonard from Wells Fargo.

[Dan Leonard, Wells Fargo]

Thank you. So, I was hoping you could offer some insight into your conversations with customers on the COVID business, and how far in advance you’re having discussions nowadays. Are you talking about customer demand needs 2022, 2023? Any insight you could offer.

[Franco Moro, CEO and COO]

It’s very important -- thank you for the question. It’s very important to say that we built the intimacy with our customers since many, many years, leveraging on our, not only the manufacturing platform, but also the scientific technologies we’re offering that is embedded in our integrated offering. So, we try to work with them in anticipating their needs. And for sure, there is also some visibility about the expectation for the ‘22 and maybe also for the ‘23 in terms of general view. But, it is very early to state what happened really because of the transition to multi-dose vial to single-dose vial, the potential transition to syringes and all the other uncertainty level linked to the boosters and so on. So, we have good visibility, but we can also state that there is a full visibility about the COVID impact in the next few years.

[Dan Leonard, Wells Fargo]

Okay. That’s helpful color. And just a quick follow-up. Marco, what’s your tax rate expectation for the year for 2021?

[Marco Dal Lago, CFO]

The normalized one is 24%. We had -- I said normalized because in first quarter, we had a onetimer positive event. We reached an agreement with Italian tax authority, benefiting by €5.5 million of tax saving due to the patent box according to the Italian tax law. But, the normalized one is 24%.

[Operator]

Next question comes from Juan Avendano from Bank of America.

[Juan Avendano, Bank of America]

Thank you. Good morning. Thanks a lot for the details on your capacity expansion plans. I have a couple of questions on this topic. First, what is your current average level of capacity utilization across your network? I’m aware that COVID might have helped utilization, but how long did it take for capacity added over the last five years, since 2016, to reach the current utilization level?

[Franco Moro, CEO and COO]

It’s a very good question. And we are expanding our capacity in the [indiscernible] COVID. And after COVID started, we accelerated some investments to be faster. And thanks a lot to our colleagues in engineering because they helped us to provide an amazing faster response to this emerging need.

In terms of the utilization, we are -- we used to plan accordingly to the standard practices to have enough downtime for preventive maintenance, or the stuff that make our supply chain robust and in sake of the certainty for our customers. So, we are at a very good level of utilization worldwide, both in vials [ph] and in EZ-Fill sterile configuration. And we used to maintain this high level of occupation.

But answering your question about how much we need -- how much time we needed to reach this level of utilization. This is the very tricky point, the very interesting point of our setup, because we don’t need them so much time, because we have engineering now. So, when we have to expand the capacity, we are very fast. So, we don’t need long time to establish the capacity and then ramping up the utilization. We are much faster than anybody else because we can tune the expansion of the capacity very close to the emerging need.

[Juan Avendano, Bank of America]

Thank you. And if you could put a number on that utilization level, just accounting for the necessary downtime and changeover. Typically, in the industry, full is defined at around the low-80s. Would you say it’s 60%, 70%, 80% utilized? If you could put a number to that, that’s what I’m looking for.

[Franco Moro, CEO and COO]

Depending on different production lines, we are in the range of 80%, 85%.

[Operator]

Our next question comes from Patrick Donnelly from Citi.

[Patrick Donnelly, Citi]

Maybe to stay on the facility expansion topic. Can you just talk about what the spend is going to look like over the next few years? I know you talked about Indiana, revenue generation in ‘23, China may be more ‘24. I guess, over the next two years, how should we think about the spend, the impact on margins, until they’re fully ramped up?

[Franco Moro, CEO and COO]

I’ll give you the picture, Patrick. Thank you for your question. And Marco may have to add more color on financials.

The idea is, as you mentioned, to have the first revenue generation coming from the U.S. plant late ‘23, beginning of ‘24, and at least six months more to have the first revenue generation in China. The total amount of money we are ready to invest to expand our high-value solution network and manufacturing is in the range of €300 million. And we’ll deploy this total investment, more or less, in 2.5, 3 years. We expect in the long run to have a revenue generation in the range of €300 million is -- two figures that are comparable, but they are different. But as you know, there are many things that we can also adjust and tune at the best during the execution of these investments. So, 6, 7 years from now, it’s not easy to say. But for sure, we are in the right position to start this investment. And we are already -- we have already started doing something in U.S. And beginning of next year, we have some news about the China.

Marco, if you can provide more details in terms of financial would be helpful.

[Marco Dal Lago, CFO]

Yes, just to complement. So, first of all, we are replicating investment we have already done here in Italy with EZ-Fill. So, we know very well the technology and the steps to be done in order to prepare the two new facilities. Measuring the return of our investment, we experienced a very good internal rate of return here in the investment in Italy, north of 20%. And also in China and U.S., we are targeting high-value EZ-Fill products. So, we expect high-teens internal rate of return in these two new plants. These are our expectations.

[Patrick Donnelly, Citi]

That’s helpful. And maybe, Marco, I’ll stay with you on the margin piece. Just -- obviously, there have been a few questions around COVID, what the revenue could look like. Can you just refresh us on the margin profile of the COVID business? Is that any different than kind of core? Just trying to think through what that could look like if it’s a bigger number next year or anything like that.

[Marco Dal Lago, CFO]

Thank you for the question, Patrick. So, product line by product line, we are not experiencing different gross margin. I mean, if we sell high-value solution, we are experiencing the same level of margin between COVID and non-COVID products, same for the solutions. So, I wouldn’t say we have a different margin profile related to COVID. Sometimes the mix is pushing more toward high-value solutions, as Franco was saying before, but apple with apple, we are not experiencing different margin.

[Operator]

Our next question comes from Justin Lin [ph] from William Blair.

[Unidentified Analyst]

Good morning, guys. I’m calling in for John Kreger today. Congrats on the quarter. And thank you for taking the questions. So previously, there were a lot of talks about COVID vaccines moving to single-dose vials. Is that still the case based on what you’ve heard, or do you think the sort of anticipated large-scale rollout of booster shots in the U.S. will likely keep it in the multi-dose format?

[Franco Moro, CEO and COO]

Thank you for the question. It’s very interesting. And we are trying to monitor this evolution together with our customers to adjust the supply chain for the future needs. I can ask Mauro to add some colors about this relationship we have with major most important players in the vaccine space to help -- to give you the full scenario.

[Mauro Stocchi, Chief Business Officer]

Sure. Thank you, Franco. Yes, just maybe to come back also a bit to what we said during our road show, actually, one of the reasons why we are so -- in a so good and intimate relationship with the customer is because we have them starting from the development phase with our solution to reach the patient in a faster way. So now, as Franco mentioned before, it is really too early to tell the future of COVID. But, what we can say is that continuing partnering with our customer is providing some indication of which the major trends could be in the future. And you mentioned a couple. So, from multi-dose to single dose is something which is, for sure, happening and at the same time, also evaluating some syringe solution in order to have a single dose ready to go to the market for the customer.

So, a lot of moving parts in the market today. But what we can say is that we are really very well positioned in order to respond to this emerging trend, specifically thanks to our engineering also part of the business, which is actually responding very fast to this kind of customer request and movement in the market.

[Unidentified Analyst]

Understood. Thank you. And just, I guess, one follow-up question on the capacity front. So, can you review your ongoing facility expansion projects outside of the U.S. and China? And where do they stand right now?

[Franco Moro, CEO and COO]

The capacity expansion, we are investing also in vials [ph] production in our network of facilities around the world. And we have some expansion also in the plastic business in U.S. and smaller investment in Europe. But now, we are really focused in expanding our high-value solutions platform that will deliver the best answer to the needs of our customers. So, for the next year, we are really focused on the execution of our investment in U.S. and China. And in the meantime, we are bridging this capacity with some investments also in Italy that will help us to move the production from Italy to the new geographies in the next three, four years.

[Operator]

[Operator Instructions] Our next question comes from Drew Ranieri from Morgan Stanley.

[Drew Ranieri, Morgan Stanley]

Hi, everyone. Thanks for taking the questions. Just to go back on the backlog for a moment, it sounds like you have good visibility for this year, maybe some partial visibility for 2022. But, just as you look at the backlog today, can you just maybe discuss or break down what backlog is from broadening your current customer relationships versus new partnerships, new customers or just geographic expansion -- early days of geographic expansion? Thank you.

[Franco Moro, CEO and COO]

Okay, for sure. You touched a very important point and this is the pipeline. Pipeline of new products will deliver additional business for the future. Most of the current backlog is obviously linked to established commercial production, because you know very well that in our market, to develop a new project, you need some time, but we are really early engaged with our customers in some very important projects. And also in this case, I think that Mauro may add some color on that.

[Mauro Stocchi, Chief Business Officer]

Thank you, Franco. So yes, we are really proud of our present pipeline, specifically also in the biotech space and biosimilar space because this is what is, of course, sustaining and providing visibility and growth for the future.

We can say that one of the main reasons for our position in the drug pipeline today has been really the critical support that our services through our tech in Boston and in Italy were able to provide to customers in order really to help them to choose the right drug containment solutions since the beginning. So, we are really growing a lot in this, supporting our customer in scientific and technology-related areas.

So, in the past five years, we have more than doubled the molecules in which we are in today. And we can say that with our today 1,100 different projects, different molecules, we are really well positioned to grow in the future in this high-value segment.

[Drew Ranieri, Morgan Stanley]

Okay. Thank you. And this might be a question for Marco. But, just on gross margin trends in the back half of the year, I mean would there be any reason that gross margins would step down in third quarter or fourth quarter from your current second quarter levels? Just as you look at having more high-value solution mix, the facility build out sounds like it might be later this year, so it might not be a full hit there. But, just curious on the gross margin trends. And then, just would you be comfortable putting out a number for free cash flow or CapEx for 2021? Thank you.

[Marco Dal Lago, CFO]

Yes. Thank you for the question. We expect gross margin in Q3 and Q4 to be consistent with second quarter, so above 31%. This is in our guidance, let’s say.

And so, going back to the backlog, the mix is positive, it’s consistent with what we are experiencing. We are moving more and more to high-value solutions. Geographically, we didn’t reply, but we are growing more and more in Asia Pacific. As you can see in the first half of the year, we went up 79% in Asia Pacific and 38% in North America. So, we are confirming the trend to move more and more toward those areas. So, we expect consistent gross margin in Q3 and Q4 compared with the second quarter.

About the question about cash flow, let me start with saying that we start with a very robust balance sheet now because we had €215 million of net debt as of the end of Q2 with a leverage of 1 with the last 12 months EBITDA. On top of it, we received the primary proceeds. So, we are now in a position where we have €165 million of positive net financial position.

The important thing to be measured in the next months will be the outflow of money for CapEx. As mentioned many times, we are investing in U.S. and China for expanding our EZ-Fill capacity. Worst case, we expect €180 million of CapEx for the current year, with a landing net financial position of €120 million, €125 million positive cash position. So, we are in a safer position, in a nutshell, as mentioned during my speech before.

[Operator]

Thank you. Our final question comes from John Sourbeer from UBS.

[John Sourbeer, UBS]

Thanks for taking my question. I guess just one on future M&A. Could you talk a little bit on what areas the Company is looking at, and the Company’s is around 1 times levered today. Does the Company have a long-term leverage target that you can provide?

[Franco Moro, CEO and COO]

May I ask to say again, because the line was just a little bit...

[John Sourbeer, UBS]

Sure. Just on future M&A, what areas is the company looking at? And then, the Company is 1 time levered. Does the Company have a long-term leverage target that you can provide?

[Franco Moro, CEO and COO]

Yes. That was much -- very clear. Sorry to ask you to repeat. Well, first of all, our broader and integrated offering is very robust. And we are really focused on exploring all the potential about the existing platform of a solution we have, and we can expand also in terms of different geographies. We mentioned several times, EZ-Fill production U.S. and China.

Nevertheless, as you know, we are monitoring opportunities to expand our capabilities with something that is -- that can complement our powerful existing integrated offering. I want to mention some intellectual property of the third parties BDS, some technologies in injection molding like microfluidics. We have some interesting opportunities to explore in the molecular diagnostic, and also in terms of design company for the design of new solution as CDMO.

These are potential M&A opportunities, but we are not under pressure to execute any M&A, if you don’t see the right condition to have the value to our integrated offer to our customer or to our shareholders. So, we are relaxed at this time. And we will apply discipline in capital allocation with a very selective approach for the next years. The financial strength, strong position will help us to make the right choices in the future.

[Marco Dal Lago, CFO]

Yes. And about the leverage, we like to play with discipline and safe, but for pursuing important strategic opportunity, we are ready to have in the range of 2.5 leverage between net financial position and EBITDA. Obviously, the condition is to create great value.

[John Sourbeer, UBS]

Got it. And if I could just ask one follow-up. Can you talk a little bit maybe on growth trends and some of the BDS subsegments in the quarter across closed containment, IVD and BDS?

[Marco Dal Lago, CFO]

Yes, we don’t provide the details. But in any case, as in the past, we are keeping on experiencing about 15% of our overall sales are represented by Engineering, another 15% by in vitro diagnostic and DBS together, and the remaining 70% is related to container closure systems. So we are consistent with this growth. We are growing in each business line and product line. We are growing more rapidly, as mentioned, in high-value solution, where in the first half of the year we went up 37%, and on a constant currency basis, we would have gone up by 33% year-over-year. So, this is where we are growing more rapidly, consistently with our plans.

[Operator]

That was our final question. So, I hand it back to the management team for closing remarks.

[Franco Stevanato, Executive Chairman]

Yes. Good morning. Franco Stevanato speaking. So I want to just take one minute in order to give the internal feedback from the Board and the management team and also our customer after this important event of the IPO of Stevanato Group.

So, the Board and the management team are extremely happy and motivated for what we have done, because it’s an important step for Stevanato after 70 years. Also, our customers are extremely happy to see Stevanato Group to continue to be present in the pharmaceutical industry and to continue to invest in the pharmaceutical industry and also will proceed.

So today, all the organization is fully committed to execute our strategy in order to continue to grow together with our customer. Our big focus is to really build the right investments in order to be more close in proximity to all our customers worldwide. And the fact that we have the trustee that will allow us more financial flexibility is even more important and well perceived by the customer.

I also want to thank all of you because in this month we learned a lot in order to do what, to have more discipline in when we give number, also to deliver number, also in the right way for the shareholders and also even more for the external shareholders. Today, our big focuses are the customers, the employees, even more the new investors that have trusted Stevanato Group. So, it’s the new exercise and new era of Stevanato but it’s a very nice moment for us. Thank you.

[Lisa Miles, Head, IR]

And that concludes Stevanato Group’s second quarter 2021 earnings. Thank you for joining us. We appreciate your support.