Lonza Group AG (LONN) Earnings Call Transcript & Summary

October 12, 2021

SIX Swiss Exchange CH Health Care Life Sciences Tools and Services investor_day 183 min

Earnings Call Speaker Segments

Pierre-Alain Ruffieux

executive
#1

So good morning, good afternoon, everybody. Really my pleasure to welcome you today in Zurich. Also very good to see some real people in this time of pandemic. It's really a pleasure to have you here. I would like also to take the opportunity to welcome everybody joining on the webcast today. Yes, even if we see some progress in the pandemic, travel still facing some restrictions. So a special welcome to all of you. I would like first to take a few moments to share some perspective on our progress since last year. Since the Investor Day, it's been a very busy time for us. We successfully completed the divestment of our LSI business, allowing really us to clearly focus on the CDMO business. In the same time, I think we have managed through a challenging time during the pandemic, clearly putting a lot of effort to help our customer Moderna to manage that, and it was quite interesting and challenging for us. Clearly, we have built on this early success. And you have seen early this year, we were really pleased to announce a double-down on the collaboration with Moderna and increasing capacity in the course of this year. We have also continued to secure our long-term growth, making significant investment, and we are going later on to highlight some of them. So clearly, we believe we are in a strong position to capture the market growth since the year to come. Having used this time to just set up the context, I would like to take you through the agenda of today. I will start with sharing some number on the company, more importantly, going in-depth with our strategic intent. And after that, Rodolfo will provide a financial update. It will be followed by a break. And in the second part of the discussion, as initiated last year, we'll make a deeper dive in our 4 divisions. Then following a second small break, we will have plenty of time for Q&A. Let's start with exploring what is the company today. If we have a look on the number we shared last year -- early this year, in the full year results, clearly, we make a significant step with the divestment of LSI. You will see our financial performance with CHF 4.5 billion sales at 30.6% margin. And clearly, this was delivered using all the effort of our division. Clearly, this is done by our people working [ hardly ] in 35 different sites across the world. In 2020, we have more than 1,000 different molecules in development in our different modality across sites. And we have produced more than 230 billion capsules. Next year, in October, Lonza will celebrate 125 years anniversary. Clearly, much of the history lie in the chemical industry. But I would like to take a short time to show you some of the key milestones leading to be the leading CDMO today. We have been working as a supplier of health care customers for more than 40 years as we're starting to supply a small molecule in early '80s. Being so early in the market, we were clearly the first CDMO company. However, our remit significantly increased in 1996 with the acquisition of Celltech. Moving into the new millennium, we were one of the pioneers in cell therapy, starting with an offering in 2007. By 2015, we have added an offer in viral vaccine. Our capsule offering, started in 2016 with the acquisition of Capsugel. And more recently, we were really increasing in scale and pace with manufacturing RNA. And I will come to more detail in a couple of minutes. So clearly, through the last 40 years, you can have seen Lonza building CDMO capability and, at the same time, divesting the old business, highlighted with the Water Care and last year with [ business ] divestment. So clearly, our history and heritage provide us with an established position in the industry. Clearly, our customers know us and we have a strong history on delivery, quantity, quality and regulatory aspect to our customers. Clearly, our customers know that we have one of the most complete and flexible CDMO offering. Starting at 12:00 and moving clockwise, we have already mentioned our work to build close working relationship with our customer. We create long-term connection bringing a broad range of value proposition. Clearly, our customers appreciate our breadth of cross modality as well as our depth. We can offer generic capacity at scale, but also dedicated capacity with the Ibex Solutions, clearly offering a great differentiation compared to other CDMO. Our global network is a very important part of our proposal. Clearly, for me, combining our 35 sites and 15,000 employees working together in a single connection network is adding a lot of value. Our global scale and reach really position us uniquely in the industry. Supported by this broad network, we can offer regulatory expertise across multiple markets and regions. Finally, our focus on quality is a critical component in our offering in our industry. Clearly, quality is fundamental for the pharma industry. Collectively, these value drivers enable us to deliver on company vision to bring any therapy to life. I would like now to share briefly a snapshot of our customer demographic. Clearly, if we have a look geographically, we are well balanced between EMEA and Americas, clearly the APAC customer base smaller, but seeing a strong strategic component of our future growth. While the vast majority of our business is with large pharma, we see also the significant part of minority growing of small biotech to midsized pharma. Clearly, this reflects the dynamics of the wider industry, where we see a lot of small biotech with strong funding from venture capital. Finally, looking at our sales by customer size, we can see that our 10 top customer remain a minority of our business with less than 40% of the volume. So clearly taking together the location, the type of customer and the size of the customer, we believe we have really a well-balanced portfolio across geography, customer type and size. This is really important for us because I think we're really derisking our business, especially in the pharma world, where sometimes a product can face challenges. To match our portfolio of customer, we have also a network which is well balanced across the world, clearly offering different type of services in the broad space, different locations, sorry. Specifically, it provides us an opportunity to deploy our network at a regional level as well as global. This allows us to remain close to our customers and ensure we have a relevant expertise to navigate local regulatory requirements. It also means that we are able to manage global issue with local solution. This makes us more resilient to potential issue like supply shortage, tariff increase or transportation restriction. And clearly, in the last 18 months, this has been shown to be true. We believe this rational view looks to more relevant in the wake of the pandemic when a resilient supply chain remains front of mind for many of our customers. As a final comment, the 3 maps reflect our extensive and established presence in Europe and in the Americas. We are already working to extend our presence in APAC and grow our China presence and it will remain a strategic focus in the year to come. It's clearly an attractive market, with high demand and a broad spread of customers. And we are working to continue to expand in this area, as I will show you in a couple of minutes with our large investment. Moving from the business overview to our strategic priority, I would like to do a deep dive on 5 of them. Before we talk to each of the strategic priority, I would like to share an overview of them. Collectively, these priorities from a focus of our business as we are consolidating our current position and set our sight in future growth and success. Our first priority is clearly CapEx investment. It will allow us to capture market demand for new and complex offering. Our second priority is operational excellence. A focus on continuous improvement will ensure that we do our best work in the most efficient way. This is critical for us to deliver for our customers while ensuring the best return for our shareholders. Third priority is innovation. Clearly, in our business, it will be tempting to think that scale and global reach as a competitive advantage. It's definitely important and we have it. But clearly, our innovation in technologies, product and business model has left us uniquely positioned in the future, and we believe it's a key part of our success and we need to ensure this continuous innovation. Our fourth priority is sustainability. Here, we are working across 3 critical areas of environmental, social and governance. We are increasingly ambitious in our approach, but we know that there's always more to do. And clearly, we believe we can only run a sustainable business in a sustainable world. Our fifth and final priority is our people and culture. And in many ways, it's probably the most important one. Not only that we do need to manage our employee number in line with our growth projects but clearly, we need to ensure that we attract and retain best talent by creating a culture in which everybody can bring his best. Let's go in more detail to each of them. As I mentioned, our first priority is growth investment. Before we have a look on the project themselves, let's have a look at our different division and the business. In the pie chart, you can see the percentage of Lonza sales each business represents. And in the bar chart, you can see how we expect the market to grow. So clearly, you can see a strong growth in Cell & Gene technology with 15% plus; followed by Biologics, 11% to 13%; and then Bioscience with 7% and 9%. Clearly, we are seeing positive growth level across all the markets we serve. We see particularly strong growth markets in Biologics and Cell & Gene technology. Turning to our growth project. We are investing in growth projects across all divisions. Currently, we are anticipating that our CapEx spend for this year would be around 25% of sales. We definitively take a very rigorous approach in assessing the new growth investment. In our projection, we expect any investment to deliver an internal rate of return about 20% and more than 30% plus ramp up of ROIC. For all our investments, we really try to derisk them upfront, and we make sure we have an anchor customer, which is securing the use of the new asset. Turning from our investment principle, I would like to highlight with the real case of we are doing that. And Ibex, in this, is a great example of what we have done during the last years. We started in 2017 with an ambitious project for 5 new building complex which will provide modular, prebuilt capacity to accelerate the customer launch to market. We have started with the first manufacturing complex #1 as well as with the Sanofi joint venture in 2017. Clearly, this has paid off as today both are operational. Complex 1 contain a number of small-scale facility and is already largely committed. Mentioning a couple of customers, we have Servier, Kodiak and also Moderna. Based on this success, we have now approved the investment for the second complex building 2, which is expected to be completed in 2024. We have already announced early this year that half of the building will be busy with 6 20,000 bioreactors of which a significant part is already contracted as announced earlier this year. The second strategic pillar is operational excellence. It's key for us as well as for our customers. Clearly, as our customers are focusing on fast delivering to the market, good quality and good delivery, we need to ensure that. It's also very important for us, obviously, to maintain our competitive advantage. We still need to remember, we do the same work as our customer. In order to be successful, we need to be much more efficient than them. And clearly, we are keeping that with operational excellence. I would say thanks to our historical focus on continuous improvement. We are already well positioned against our customer need, however, I think we can always do more. We are looking about a new way to improve productivity in our base business, looking at productivity of cell line, utilization of equipment, yield purification, also for new modality like mRNA or Cell & Gene Therapy. Flexibility is also key or we can move from an asset from one customer to the other customer, increasing the utilization rate. Finally, we are also aware that our growth investment provide us with an opportunity for innovation that will drive the new generation of operational excellence. So based on our previous experience, we make sure that our assets are really providing competitive advantages. So clearly, it's why we are also focusing on all our investments are bring to market and not only or we are using them later on. As I mentioned, differentiation is really key, so we need to focus on innovation. I will go later on much deeper in the different division and innovation, but I would like to highlight at this stage 4 different aspects. For Biologics, we made a significant progress over the last 2 years on manufacturing at large scale of mRNA. We see a boom of demand in small customers. So we are putting in place early-stage development expertise and capability. Having a look at Small Molecules, clearly, we are increasing our capability in producing complex, cytotoxic product in conjunction with the antibody drug conjugation. For Cell & Gene, we will see later on, we are working on Cocoon, a system which allow automation of all the part of cell and gene therapy, which is very labor-intensive. In our CHI business, we are working with new type of capsule which really allow targeted delivery of drugs, bringing a lot of added value to our customer. So really with that, we'd like to show that we believe that winning in the CDMO space is not about -- only about capacity and excellence in execution, it's also bringing new value for our customers. Moving to our next priority. Clearly, sustainability is a core strategic pillar for our business. It really means having a positive impact on our people and our community as well as protecting the environment. As part of our responsible approach to the business, we are addressing legacy on the environmental issue, and I would like to highlight that with 2 recent examples. First of all, we completed an investment of CHF 12 million which is really allowing us to reduce our nitrous oxide emission in this by more than 98%. At the time of half year results, we have also announced a provision of CHF 290 million which we are going to spend over the next 10 years, allowing us to solve our legacy issue with pollution in our landfill site in Gamsenried. So clearly, we are taking responsibility and fixing the legacy issue from the past. At the same time as we are resolving that, we are taking a wider and more strategic view. With the focus now of a new set of measurement, we are adjusting our ESG action plan. And we are clearly aligned with some the United Nations targeted. We know that it's a long journey and there will be always more to work in this critical area. But definitively, by taking some KPIs, but also putting them as target for management, we are convinced we will make significant impact and long-term improvement on this field. Last but not least, our people. Clearly, over the course of last 2 years, we have grown our employee by 1,700. And today, we have around 15,000 employees across our global network. This has been a particular achievement as much of the recruitment took place during the pandemic. When you have to onboard new office colleagues and they cannot see the other colleagues and they do it remotely, it's not easy. At the same time, in manufacturing, we need to find a lot of people, onboard them, train them on safety and make sure they are operational. Today, we are really proud that we have a hard working skill and committed employee base that represents more than 100 nationalities and 60 different language. We are also pleased to report 30% female leadership, both at the executive team as well as the Board. Looking at the wider employee community, we can report a retention rate of more than 90%. This really reflects the work of a leader in ensuring that Lonza is a true place where people can come, stay and grow. To support our work in attracting and retaining top talent, we have worked over the last year to build a clear identity, supported by our company culture. We have shared and embedded a set of cultural value, which we call the 4 Is, clearly focusing on integrity, inclusion, innovation and initiative. We work this -- we believe that how we work is as important as what we do. We have worked this to unite our colleague with a single vision to bring any therapy to life, clearly with the motivated purpose to enable a healthier world. You have probably seen this year in the press our effort to get people in this. And clearly, what we have seen, the willingness of the young generation to make an impact, to contribute was huge. I'll tell you, we see now with our new focus on our vision, a lot of attraction and visibility in the young generation. Clearly, people are engaged by opportunity for personal and professional development and excited to work in a dynamic company that is growing at speed and scale. Taken together, our strategic priority helped us to paint a positive and confident picture on our future success. Our current performance benefit from our focus on operational excellence and a continuous improvement. At the same time, we are continuing to grow our employee community, which is particularly important as we bring new assets and facility online. Looking to the long term, we continue to see sustainable level of market growth and demand. We will capture this by maintaining momentum with our growth investment and redoubling our focus on sustainable value creation. Taking all this into account, we are pleased to confirm our 2024 midterm guidance at low teens sales growth. We also expect to achieve around 33% to 35% core EBITDA margin and double-digit ROIC. I will now hand over to Rodolfo to provide more detail on the financial update. Thank you.

Rodolfo Savitzky

executive
#2

So a warm welcome from my side and many thanks for joining us today. Pierre-Alain has gone through the key priorities for Lonza, and I will take now the time to describe the key financial pillars that underpin our strategy. So we will talk about the value creation model, our priorities for capital allocation, our target capital structure and then the midterm guidance for the group as well as by division. Our growth engine is the investment in capital and in people. Now we like to think about our business model as a combination of growth investments in base business. And growth investments accelerate growth, margin, ROIC over time, and they are financed by our base business. We will talk about these 2 elements in much more detail, but for now, let me remind everyone, the base business is growing steadily behind throughput improvement, operational leverage and operational excellence. Now on the growth project side, they provide this acceleration in terms of sales, in terms of margin, but this comes with a certain lag. And this leads us to the next slide. And here, we can see the sales evolution model on the left. In the absence of growth programs, the base business would be growing low to mid-single digit. Now the growth acceleration that you see in 2021 to 2024, this is driven by the growth investments we did in the past, in 2017, 2018. You may remember some of these investments, like the JV with Sanofi or our Ibex program in this. Now the investments we are doing today, in 2021, '22, they will accelerate the growth in 2024 and beyond. And you can clearly see that in the graph. Now if you turn to the right, this is a description of the ROIC evolution over time. And here, you see a steady improvement in ROIC, driven by the base business. And of course, the growth projects provide an acceleration when they reach, let's say, fully ramped-up sales, we're talking about ROIC levels of 30%. But of course, there's an investment period while we build up the facilities, ramp up their facilities and they reach a high level of capacity utilization. Now for our business model, it's imperative to keep a high level of operational excellence to drive sales growth, margin improvement over time, ROIC, and also the execution of the different growth projects. Now what you see here is a depiction of different P&L lines. And here, we will describe the value levers associated with each of these lines. Now from the chart, you see that the biggest levers, of course, are base business cost of goods and then the administrative costs. Here, of course, we see significant opportunities for margin improvement if we think of base business costs behind tighter improvement, reduced cycle times. And in general, doing things right the first time. In admin, we have done a lot of progress in terms of process excellence, automation, to make sure that we can support a higher sales base with a proportionately much lower increase in administrative resources. Now the operational excellence is also critical for growth projects. Here, it's important to make sure that the CapEx deployment is done properly and also the ramp-up of the different investments. On the marketing and sales side, we have improved our market data business intelligence. So again, with the same idea that we can more precisely target the right customers, the right programs. And we can do more or support higher sales with less resources. Now R&D remains a big investment area. And here, we can see opportunities for innovation across all the value levers in Lonza. And just to give a few examples, in terms of improving bioprocessing and automation with robotics, sensors, improving cell lines with next generation of cell lines. Now this leads me to this slide where we talk about our capital allocation. And here, our strong EBITDA and cash flow has been complemented with the CHF 4 billion proceeds from LSI. Now as we have mentioned before, our #1 priority remains organic investments. Pierre-Alain has described that in his section. These are investments with very high rate of return and low risk profile. So these remain our #1 priority. We will also do some bolt-ons or we plan to do some bolt-ons, and we'll describe that in a few slides. And finally, we do foresee to continue to provide a dividend of 25% to 40% of net income, but we do not foresee any other capital returns because we have just a lot of very attractive investment opportunities. Now on the CapEx front, we foresee to maintain what we have guided for the year, a 25% of sales CapEx and to maintain this in the coming years. Now importantly, the CapEx goes across all the divisions. You see that in the graph at the top. And in general, what we see is that 80% of our CapEx is deployed in growth investments and the remainder is maintenance CapEx. Now the question we get frequently is, okay, what's the trajectory, right? You see it in the graph. And this is difficult to answer. It's difficult to predict. The real answer, it all depends on the opportunities that present themselves over time. If we see a lot of attractive opportunities to invest and capture the demand, we will do so. But for the time being, the plan foresees a return to the high teens by 2024. Now talking about this increased CapEx investment, the question of risk is an important one. And here, again, I reiterate the message shared already, the level of risk of our programs is low. And why so? Basically, for every program, we have a certain level of the commercial projections, which is already contracted, say, with an anchor customer. And in other situations, we have a very clear pipeline of projects that goes against the specific investment. And here, we have programs in early negotiations, late negotiations, and we have a lot of experience of pipeline conversion into real contracted sales. So in that sense, the -- let's say, the level of risk associated with the investments from a commercial point of view is relatively low. The other thing to keep in mind, most of these contracts go for 5 to 7 years. So once the capacity is contracted, the financial return is pretty much guaranteed. This leads me to the other investment opportunity, which are bolt-on acquisitions. Let me start with the right-hand of the slide, the guardrails. First, for every investment opportunity, it has to fit completely with strategic priorities. Given that we're talking about acquiring assets, like sites, in many cases, we always made the comparison what is the buy versus build? And in general, the expectation is that M&A projects will be relatively fast, ROIC-accretive. Now what are the M&A priorities areas? Strengthening the core, expanding the value chain and accelerating innovation. In terms of strengthening the core, here, it's capturing short-term demand with existing facilities or reinforcing our regional presence. And here, of course, the advantage of buying an existing site, it comes with commercial portfolio, with workforce and, of course, accelerates delivery of revenue. Now the consideration here, it has to have the right manufacturing process, culture, quality standards so that it can really fit in the Lonza network. Now in terms of expanding the value chain, you have heard us now many times talk about expanding into commercial fill and finish. But there are other opportunities, right? Like, for example, vertical integration in several components like, for example, media for cell and gene therapy, these are areas we could also selectively look at. And finally, on accelerate innovation, we're looking at ways of improving bioprocessing and with automation, robotic, sensors, for example, cell lines, the next generation of cell lines. This is the type of investments we're looking for. Now we talked about investing, and now we need to look at the other side, the financing and the balance sheet. Currently, with the proceeds from LSI, we have roughly CHF 1 billion of cash. And the expectation is that over the time frame of the midterm guidance, we will return more or less to the pre-LSI divestment leverage levels. Our key priority and objective is to remain -- clearly remain investment-grade rating. Now a few of you will be doing the modeling and the math and with the dividends, with the CapEx, you'd say we would get to a much lower leverage level. And of course, here, what comes in our own projections is a couple of billion Swiss francs behind bolt-on acquisitions. Now all of this leads me to an important topic in the agenda, the group midterm guidance. Now what has changed since pretty much a year ago? First of all, Today, we're talking about 2024. Last time, we were talking about 2023. So we have moved 1 year further out to keep this 3-year planning horizon. Then when it comes to the sales growth, we are guiding for low teens. And this, again, just to remind everyone, this is underpinned by throughput improvements in the base business and the investments in growth projects that we have done in the past 3, 4 years, right? Then from a core EBITDA margin, we maintain the guidance of 33% to 35%. And this is a reflection. First, we are prioritizing growth over margin expansion. In the -- again, the other consideration is we're increasing the level of investment, right? And so this has an impact shorter term on the margin. Still, we expect a sustained progression of margin year-on-year until reaching the guidance in 2024. And last, but not least, we -- we're guiding for double-digit ROIC, which simply underscores the strong ROIC generation of our base business overall as some of the impact of growth projects in the very short term are ROIC-dilutive. Now let me turn to the guidance by division. Here again, let's do a quick reflection of what has changed versus what we presented last time. First of all, in terms of guidance, last time, we presented the sales growth, right? But on the margin side, if you remember, we had a reference of, at the time, what was the estimated H1 2020 margins and an arrow indicating the general direction we expected the margins to take. In this time, we're providing more transparency, going one step further, and we're providing a specific margin guidance for 2024 for the different divisions. Now comparing the guidance from last year to this year, we have upgraded guidance in Biologics since '17 and just taken concurrently a touch down the guidance in Small Molecules. Now let me just briefly describe or go through the chart here, just mentioning the different guidance. In Biologics, for sales, we foresee mid-teens and margins by 2024 above 35%. Then in Small Molecules, we go for high single-digit growth and margins above 30%. And here, very clearly, this is underpinned by our growth in highly specialized segments like HAPIs, which have relatively fast growth. Now in the Cell & Gene division, right? Here, it includes the portfolio, you remember, of Bioscience, while it's properly Cell & Gene Technologies and personalized medicine, we go for mid-teens. And here, the growth is fueled by Cell & Gene Technologies. And then margin above 15%. And here, again, this is driven to an extent by the improvement in cell and gene where we expect to reach a breakeven in quarter 4. Last but not least, in capsules, we said similar to last year, low to mid-single digit. We expect this is the only one where you see this sign at the -- in front of the 35%. We expect a sustained 35% margin over time. So just a couple of final thoughts from my side. I've described the Lonza business model. And we have seen a very successful sales growth in margin evolution and ROIC evolution over the past several years behind this model. What we're discussing today is a continuation of the model with some acceleration of investments, right? But this is what is underpinning the delivery of our 2024 midterm guidance and, very importantly, growth -- sustained growth beyond this guidance. Last but not least, it's not all about investing. It's also about having a rigorous discipline in terms of execution to make sure you have operational excellence in the way we drive the business to ensure we continue to see productivity, margin improvement and ROIC. Let me end here. I'll pass it over now to Philippe, who will introduce himself as he will be taking over the finance baton in the coming years.

Philippe Deecke

attendee
#3

Thank you very much. Hi, everyone, and thank you, Pierre-Alain, to provide me the opportunity to present myself quickly to you and to all the analysts and investors on the phone today. So let's start with my background. I'm an engineer. I have a Master's in Industrial and Manufacturing Engineering from ETH in Zurich and an MBA from Cornell University. After that, I joined McKinsey. I had projects, broad scope of health care industry segments, including medical devices, generics, as well as innovative pharma and a lot of supply chain type of project as well. I then joined Novartis for the last 16 years of my career, all career in finance, covering local roles, regional roles as well as global and divisional CFO roles, ranging from former division, Alcon, in the ophthalmics medical device industry. I was then 3 years the CFO for the Sandoz division in the generics industry, covering both small molecules as well as biosimilars. And for the people that know the generics industry, this is a highly-intensive, commoditized industry where manufacturing plays a big, big role. And we spent the last 3, 4 years really reviewing the network, improving efficiencies and driving flexibility and resilience in the network. For the last year, I was the CFO for the oncology business unit at Novartis, a 15 billion business. And technically, I'm still part of Novartis today, but very much looking forward to joining Lonza in a few months. So I very often get the question as to why am I joining Lonza today. And it's a very simple answer, actually. You heard from both Pierre-Alain and Rodolfo, it's a great company, very, very appealing purpose, something that's close to my heart. And I think it's the leader -- the clear leader in the CDMO space based on its innovation power, it's flexibility, it's focus on quality and the extraordinary customer focus that the company shows every day. So that's reason #1. Reason #2, I would say is the -- with the focus on the pharma industry, I can truly bring in my 20-plus years' experience in pharmaceuticals, covering both innovative space, biologics, but as well more kind of low-cost generic side of the business. And then third, something that's important as well. For me, Lonza is a true corporate Swiss icon. And I'm very humbled and proud to be part of the leadership team of this company with the true ambition to give it on to the next generation as a strong and greater business as it is today. So for me as well, it's a chance to be an external CFO, a CFO of a public company. So this is my personal ambition, to get to work a lot more closely with you, with our investors and shareholders, something that has been a goal for myself for a long, long time. So how would the next few months look like for me? Officially, I start December 1. So I'll be doing a lot of desk research. Until then, I have no access to any internal information from Lonza. So whenever we're in the break, don't ask me questions about Lonza yet, but I'll be working towards that. I'm looking forward to start in December, handing over from Rodolfo. Thank you very much, Rodolfo, at this point in time, for your time. Getting to know the executive committee, getting to know the 15,000 people working for Lonza today that make this company the great company it is. Last but not least, I'll be supporting Pierre-Alain. I'll be supporting the Executive Committee to make sure that all the investments that we're doing continue to deliver value for our shareholders and stakeholders at large. So with that, thank you very much. I look forward to connecting more closely with all of you, probably starting in January around either JPM for the one that will be there, or at the time of our full year results at the end of January. With that, my introduction would be over. I have the joy of announcing the break, which will be around 15 minutes. And coffee will be served outside for the people in the room. I guess for the people on the webcast, just go grab a coffee and come back in 15 minutes. Thanks, everyone. [Break]

Pierre-Alain Ruffieux

executive
#4

Okay. So welcome back. In this next session, I will take you around the short tour on each of our divisions. I think we will start with Biologics before moving to Small Molecules. And then moving to Cell & Gene. And finally, wrapping it with the Capsules & Health Ingredients. As mentioned, after that, Rodolfo, and I will be pleased to take your questions. Okay. Let's start with the Biologics division. Actually, in this division, we use advanced technology to quickly and efficiently deliver a broad portfolio of customer offering. It's, as you know, our largest division, with 48% of our group sales. Clearly, in our Biologics division, we have a broad offering. We stretch across multiple modality and development phases. We serve our customers across clinical and commercial manufacturing and across all the product life cycle. Let's have a short look on each modality. Clearly, Mammalian remains a major production technology for the industry. Here, we have a full service, really starting its early development to full scale mammalian scale. Bioconjugates, it's really a growing case of biopharmaceutical. I'll tell a couple of words more on that one, which clearly we see high demand in the market. Clearly, our leading capability in this field is allowing us to capture of new -- a lot of new opportunity. And we have really end-to-end capability in this field. mRNA, it's a good example of all Lonza work. Clearly, this is a technology which has emerged in the last couple of years. And based on internal expertise, pre-investment in facility, I think we have demonstrated during the COVID crisis, we can bring to life new therapy in a very efficient way. Again, I will share more detail later on. Microbial, it's a very attractive technology for many of our customers. Clearly, for the one working with complex therapeutics. Clearly, our offering from mid- to large-scale commercial manufacturing is allowing us to support many customers, also having our own proprietary expression system. If I'm moving to Drug Product Services, we are currently expanding our commercial capability, building on a strong clinical offering. Finally, we have a large division where we also get resource revenue through licensing product and technology to third-party. As we -- turning to the wider market, we can really see a healthy and existing growth in the biologics market. Current forecast suggests the compound annual growth rate between 10% and 13% over the next 4 years. Clearly, there is multiple trends supporting this growth. First of all, I think we see a very strong pipeline growth across all modality in existing sales and driving a need from both clinical and manufacturing services. We see also a growing number of molecules in the pipeline, which are developed by small biotech to virtual biotech. And what is interesting, this company, generally, they don't have any manufacturing site, they are quite virtual. But also they have a tendency to move along the value chain. Historically, they were stopping their own work after Phase I, but we see now, with extra funding, they go into later phase and even up to the market. Looking more widely, we see an increased complexity of therapy, which really is driving CDMO demand. We also see the balance of demand shifting, with the increasing number of small companies playing a key role in this suite. Finally, last but not least, we see new type of indication driving demand, and partially also because molecular antibody are more affordable than the past. To mention 2 classes, currently, there is a lot of demand linked to COVID-19 neutralizing antibody. But we have also seen a new type of disease like Alzheimer's driving the demand up. Having seen the growing business market, I would like to describe more on strategic priority. So clearly, first, we intend to further strengthen our end-to-end offering. Second, we're continuing with our plan to increase our presence across modality and geography. And the map on the right gives you a sense of expansion plans across all modality. Third, we clearly intend to leverage global capability to offer an agile delivery and model. By providing our customers with different manufacturing option, we were able to offer flexibility in a dynamic market. Fourth, we clearly continue to maintain an active approach in innovation, which help us to which we continue to operate to the cutting edge at manufacturing technology for our customer. Clearly, by focusing on these 4 priorities, we see a lot of opportunity to continue to grow this part of the business. We have definitively one of the most complete offer and flexible CDMO portfolio. But nevertheless, we continue to further develop end-to-end offering in order to ensure we continue to capture market demand in an integrated approach. On this slide, you can see with the cycle of our strongest offerings. So obviously, we offer everything from Mammalian, from late discovery to commercial; a very strong presence in Microbial, too. But you see new technology where we are leading in the market, like bioconjugates, offering also end-to-end capability. And mRNA, for the last 2 years, very strong presence in commercial. And as I mentioned before, we also develop our offering in clinical development and supply. Drug Product Services, a very strong presence now in development and supply for clinics, and we are now expanding capability in commercial. With more than 20-year experience in my mammalian cell culture, we have clearly established a respected and leading position in this space. This is supported by our integrated offering across the entire process and product life cycle, from late discovery to commercial manufacturing. Clearly, we are also using industry-leading technology, like our proprietary system GS Expression System in mammalian expression. Using this kind of expression system and our expertise is giving confidence to our customers that there's much more likelihood to reach market, which is very important. It's allowing less risk but also cost-effective approach. Our broad capability are reflected by our development and manufacturing capability for complex biologics molecule. This has proven particularly beneficial in capturing growing customer demand for biopharmaceutical. Clearly, also, our global network is an important component of our value proposition. It allow us to be close to our customers and provide a wide range of technology and asset size. Looking at our recent network growth, we see that additional capacity is coming online in Portsmouth, Visp and Guangzhou. This broad distribution again reflect our commitment to support our customers in every region. We also continue to invest in growth, as evidenced by our recent announcement in the mammalian facility in Visp for the 6 20,000 as well as Portsmouth. Clearly, this is illustrated with 2 customers, Genmab and Alexion. As I mentioned, our global network of mammalian asset is set up so we are close to our customers and can support them at a local level. Looking at our current distribution, we are strategically positioned across the key 3 region. A significant proportion of our existing customer base is located across America and EMEA. At the same time, we see clearly APAC as an attractive market with strong growth potential. Developing our position there will enable us to capitalize on this future opportunity. Let's move from mammalian to bioconjugate. With more than 15 years of experience in the modality, we are amongst the first CDMO to support the commercialization of bioconjugate. As with Mammalian, we have the leading experience and an integrated offer for the established -- for this established and growing class. Antibody drug conjugates make a large part of the bioconjugate pipeline. In this area, we have clearly captured most of the demand with an integrated offering and capability across all ADC elements. Clearly, to share an example, we partner with Roche more than 15 years ago with the production of 2 oncology ADC. Actually, this capability has proven to be a great value for Roche. We are illustrating also that with another example with Kodiak. Our broad range of experience and customer credential in this area provide us clearly with opportunity to extend our existing partnership across the supply chain. To harness the full commercial potential of bioconjugate, we have recently expanded our conjugation suite in Visp, which include multi-product and dedicated offering. Finally, we are focused on enhancing our early-phase services for bioconjugates. This helps to consolidate our position as a preferred partner for customers with conjugate in Visp with innovative pipeline. Now let's take a moment to focus on mRNA topics, which clearly placed Lonza in the spotlight over the last 18 months. In May 2020, we announced a 10-year strategic collaboration agreement with Moderna, commencing with the manufacturing of a Moderna COVID-19 vaccine drug substance. On the picture, you can see the situation in Visp in early 2020 in the production suite. You cannot see in the basement all the utility, which are pre-invested, which are really part of the concept, but you can see quite an empty space. Eight months after that, in December 2020, we were producing the first batches. Clearly, you can see how we were able to answer a fast need from the customer. And this is really underlined with the news we published this year that Moderna is doubling down on the collaboration with Lonza and doubling the capacity in Visp place. Clearly, the potential of therapeutic value of mRNA is not limited to COVID-19 vaccination. We currently see more than 200 drugs in development. And I think as a first mover in manufacturing, we believe we are very well positioned to capture future growth in this market. I think the -- this has also demonstrated the capability of Ibex offering. Generally, we like, after the Market Day, to make a visit in facility. Obviously, this year, it's not possible. But I would like to illustrate these 2 points with the short video. Please. [Presentation]

Unknown Executive

executive
#5

In the health care industry, accelerated times to market can unlock the key to competitive advantage. However, the path to commercialization is complex, uncertain and fraught with risk. Our customers must navigate the development and manufacturing process by balancing quality and regulatory requirements alongside time and budgetary constraints. This is why we developed Ibex Solutions. Ibex is a network of prebuilt facilities supported by a flexible and responsive business model. Lonza remains derisked by focusing investment in a shell and infrastructure. This enables our customers to accelerate production times and manage their risks by defining manufacturing commitments in line with demand. We originally commenced the construction of Ibex in 2017 in Visp, Southern Switzerland. And 2 large manufacturing complexes are already complete, including our joint venture with Sanofi and manufacturing complex 1. Existing customers benefiting from the Ibex offering includes Servier, Kodiak and Moderna alongside many others. Based on this success, we have now approved the investment for the second manufacturing complex which will expand our capacity and further enhance our customer offering. The value of Ibex is best demonstrated by how we've scaled mRNA technologies to industrial levels. In just 9 months, we were able to convert an existing prebuilt facility shell into a global manufacturing hub for this new and complex technology. By ensuring speed of access, mRNA has presented us with the pathway through the COVID-19 pandemic. But its impact does not stop there. It also looks at to revolutionize the way we approach certain treatments and vaccines in the future. At Lonza, our investments in establishing industrial scale mRNA production over the last 2 years have demonstrated the customer and commercial advantage delivered by Ibex Solutions. And our recent work with mRNA has illustrated our transformative impact on customer delivery times. We are now uniquely positioned to support on mRNA programs for customers in the future.

Pierre-Alain Ruffieux

executive
#6

On this example, we can clearly demonstrate the 2 aspects of being very agile in acquiring new technology, but at the same time being able with pre-investment to respond quickly to customer needs. I would like now to share a little more on what we are doing to strengthen our drug product service capability. Clearly, this is a growing part of our Biologics offering. Our work in this space provides further link in the value chain and extend our integrating offering. Even if this is a relatively new offering, we have now manufacturing facility in Basel and Stein in Switzerland. We expect this facility to be operational in the beginning of next year as well as Guangzhou in China in Q2 2020. This multimarket network is operated by more than 300 employees and serve more than 100 customers. We have recently confirmed the further expansion in our facility in Basel to increase manufacturing capacity in line with growing demand. Our assets allow us to provide analytics, formulation as well as pharmaceutical development and process development services. And our people provide an extensive expertise in parenteral drug product development, manufacturing as well as testing. Combined together, our capability means our drug product offering have a leading position in the CDMO space. They allow us to provide on integrating drug substance and drug product offering across all key modality, with particular expertise in complex and challenging project. I think, explore some modalities, let's return to a bigger picture of our Biologics division. This global overview gives you a sense on how we are strengthening our presence across modality, development stages and geographies. By doing so, we ensure an appropriate global presence that is in line with where our existing customer are based and what they need in each location. Our rationalization capability also supports business development, but allowing us to connect locally with preferred new customer, being able to bring them into our network at the early stage increase definitely our chances of working with them long term and growing the relationship into market and region. A clear example of that is, for example, our presence in Hayward, California being very close to a lot of start-up, capturing new customer. A clear differentiation of Lonza is clearly our capability to provide generic capability as well as dedicated capacity. So we really make sure we offer, too. As the market and molecule grow in complexity, we find that each customer come to us with a unique set of needs and challenges. Increasingly, we see that it's vital for us to be agile and adaptive on how we manage our customer need. On this graphic, you will see that we have divided a Biologics offering into more the traditional and tailored approach. This is a simple -- a slightly simplified view, but it clearly allow us to explain how we work with customers. In the CDMO space, we take a broad and deep approach. We have an extensive network, covered with a wide range of modality and adding value at multiple states of the journey. Clearly, this breadth is completed by our expertise in clinical development and commercial manufacturing as well as, we should never forget, the regulatory expertise. Our customized solution can be adapted to customer needs with technology-agnostic solution, flexible ownership and agile operation model. This provides opportunity for customers to manage fluctuating demand while accelerating time-to-market. A typical example is what we have done for Moderna. I mentioned before Kodiak and some others. So really, this specific offering, dedicated offering is having a huge impact. I mentioned in my introduction innovation. Clearly, before closing on -- the next slide, please. Before closing on Biologics, I really would like to share a few examples on innovation arising from our work in R&D. For difficult-to-express and complex biomolecule, our expression system provides a scalable and consistent approach to production. Our GS piggyBac provides a robust and scalable fully integrated expression platform, free to accelerate delivery of the next-generation biologics. As well as managing complexity, we also see the need for continuous improvement. Our continuous manufacturing provides an opportunity for us to optimize our existing assets and improve efficacy. We are continuing to look at options in this space, which can clearly increase delivery while protecting quality, reliability as well as value. In the last 2 years, we made a solid progress in expanding our modality portfolio with the mRNA platform. However, we can still see a lot of work to be done in this space, especially as I've mentioned before, in early-stage and small-scale capability. This work will be supported by technology and process improvement. And as mentioned before, we see a huge range of opportunity with more than 200 products under development. Finally, as mentioned by Rodolfo, our technology offering may be extended and improved by future focus on automation. This will allow us to greater real-time control over bioprocess performance and also simplification in some modality. I will come later on with our Cocoon offering in this dimension. Moving on from Biologics, let's now have a look on the Small Molecules. This division specializes in customized development and manufacturing of active pharmaceutical ingredient. Our service spans the journey to market from concept to commercial supply. The Small Molecules division accounts for 15% of our sales growth. Looking at the division as a whole, we have an established and differentiated offering, with particular expertise with complex and small molecule. Looking first at drug substance. We are a leading player in a highly fragmented market. Wider market growth sits at around 5%, and we are showing above-market growth compared to this average. Our customers in the drug substance space range from the virtual company to large pharma player. We work to meet their needs in the development and production of intermediate of APIs with clearly a focus of highly potent APIs and complex processes. Turning to offering in particular, engineering and drug product. We are again able to claim a leading market position and above market growth rate. Particularly engineering offering is designed to create optimal particle size so that treatment can be easily absorbed by the circulatory system. Complementing these services, we provide rapid early-stage clinical supplies in an integrated package of drug development. Looking at the wider market, small molecule treatment comprise around 70% of the pharmaceutical market. Clearly, this market is fragmented and different area are growing at different rate. One of the fastest-growing area is a highly potent API area, which is currently showing 8% to 10% growth. We have a clear and compelling offering in this space, and it will remain a focus for us in the future. Around 80% of the clinical pipeline is owned by small and emerging biotech players. The business model often focus on faster time to market, as a key achieving -- for achieving a competing edge. We understand this, and we make sure that our smaller biotech partner can rely on our rapid and early-stage clinical supplies to gain advantage speed. At the same time, we also see an increased level of complexity in small molecule. This can result in longer synthetic pathway and on poor bioavailability. Our particular engineering offering can be critical in enhancing bioavailability of this complex small molecule. As we look to the future, we plan to grow offering across our 4 existing production bases in Visp; Nansha, China; Bend; and Tampa. Early this year, we have already committed to a significant expansion of our small molecule operation in Visp, which will help us to expand our regional offering in Europe. At a strategic level, we will focus on strengthening our portfolio in the highest value area of the market. Clearly, we have 4 strategic priorities. First, we will work to strengthen our early phase offering. Second, we are expanding our capability in complex and highly potent product. Third, we will deploy new agile manufacturing solution. And fourth and final, we are finding a fresh way to innovate to gain speed. Let's go to some more detail. Let's turn on how we are working to strengthen our early phase offering. This is clearly important area. As we see that the majority of new drug approval in the market are already on an accelerated pathway due to the type of indication. This clearly means that speed is of the essence for our customer to capture commercial advantage. Our SimpliFiH is an integrated offering that is designed to reduce the time from initial ID to first-in-human clinical verification. From a scientific perspective, the offering address the bioavailability challenges that can be associated to new and complex molecules. From a business perspective, the offering accelerates the pathway to Phase I clinical trials as well as reducing complexity, risk as well as cost. Our second priority is to strengthen and consolidate our position as a leading manufacturer of complex and highly potent APIs. Our current offering provide multiple advantage by addressing multiple challenges for customers who are working in this space. Our capability and expertise in this area means that we can respond to almost any synthetic process to make new molecules. Our customers also benefit from our ability to customize our assets to meet the specific needs of the molecules. This is complemented by our integrating approach as we are able to progress from clinical to commercial manufacturing for our customer within a single site. Turning to some recent highlights. We have been able to support a large pharma customer, who came to us with a complex and highly potent cytotoxic molecule. By providing a dedicated facility, we were able to process this highly toxic substance efficiently in a contained environment. I think we were also able to support AstraZeneca with a very flexible solution to accommodate changing demand. AstraZeneca is not the only customer that is looking for flexible solution to accommodate fluctuation in demand. We see this increasing industry channel as an opportunity for us to deliver more agile solutions that anticipate evolving customer needs. Similar to the Ibex solution for biotech, we have, in April this year, announced our plan to build a new manufacturing facility for dedicated small molecule offering. Our CHF 200 million investment is already derisked as it reflects the capital contribution from an established customer. With the operation to start in 2023, the new facility will comprise of 2,000 square meter manufacturing complex with a dedicated suite for antibody drug conjugates. Taking inspiration from our Ibex offering biologics, the new facility will actually also pre-built shell, allowing future flexibility. Moving to innovation. As for other division, innovation is an important aspect. And we have several R&D priorities in small molecule. Let's highlight a couple of them. As I mentioned, reducing time to clinic is really key for many of our customers. This is why using a computer-simulated in silico route selection process, we can really expedite the pathway for drug substance. This is supported by our predictive model for drug product formulation. I have already mentioned before the importance of enhanced bioavailability. This is significant on all [ ECs ] body can absorb therapeutic treatment. This is particularly a challenge for highly potent molecule. In this space, our spray drying technology clinically enhance bioavailability of low solubility molecules. Turning to inhalation. We are working to deliver a higher level of efficacy with reduced dosage level. We are achieving this through local targeting of drug substance administrated by inhalation. We are clearly also exploring if spray drying can be used to manufacture dry product pulmonary formulation for inhalation. Finally, we continue to drive innovation in the area of complex small molecule. We are always exploring how we can bring innovation to our technology and processes. We are also working to ensure that our production facility at advanced level of containment and automation, which are clearly particularly important for this type of component. Now let's move to -- from Small Molecule to Cell & Gene, the third of our division. Our Cell & Gene offering include development and manufacturing services, product, solution, testing and automation platform. We also develop tools and technology to develop the risk neutralization processes. Currently, Cell & Gene division is our smallest by revenue, represents 10% of group sales. However, we see high commercial potential in the division, and we are confident that this proportion will change in the years to come. Within the Cell & Gene division, we currently have a portfolio of strong and complementary businesses. First, looking at the Cell & Gene therapy, we are focused on providing CDMO services across Cell & Gene therapy modality. As we begin to manage the complexity in manufacturing processes, our Cell & Gene technology looks set to transform the way we treat patients with cancer or genetic disease. Understanding the potential, we see market growth rates of more than 15% for the modality. We are tracking above this level, and our margin remains on track to hit the rate even in -- by end of this year. In our Bioscience business, we provide raw material and instrumentation for Cell & Gene alongside other therapy area. Here, we see a 7% to 9% market growth. Again, we see above-market growth in our own business with margin levels that are accretive to the group business. The final component of the portfolio is personalized medicine. A prominent part of this business is our Cocoon platform, a closed automated system for patient-scale cell therapy manufacturing. Cocoon enables consistent and reliable quality level and provide opportunity to scale up and customize patient treatment in an innovative way using technology. Our capability allows us to provide a differentiated offering to our customer. We are able to support across all Cell & Gene modalities. Our market-leading position in autologous and allogeneic cell therapy manufacturing is complemented with the strong viral vector offering. In addition, we serve as one-stop shop for the Cell & Gene market. Clearly, by working with us, customers receive access to an integrated tranche of services to accelerate their path to the market. Our work in this field is backed up by deep level of expertise and strong track record. With more than 20 years of experience, our Cell & Gene technology business currently supports more than 160 customers over -- with more than 150 projects. Finally, we are well positioned to capture market potential with the network and capability. We have 1,200 employees working across 4 sites, including our landmark Houston site, which provides dedicated focus for Cell & Gene technology businesses. Extending to 28,000 square meters, Lonza Houston provide a center of excellence for Cell & Gene therapy offering. It's really the home for more than 400 employee and covers all of Cell & Gene therapy modalities. Specifically, Houston forms an important center for our capability in late stage and commercial Cell & Gene therapy. The site was officially approved for commercial production of therapy by FDA early this year. We are currently focusing on further expanding our capacity at the site to provide manufacturing space for existing operations as well as a shelf space for modular expansion in the future. Looking more widely at our late-stage and commercial offering, our customers benefit from access to end-to-end support across modality, established quality insurance mechanism and a derisked path to filing. The high-end level of interest in this set of services means that we are currently have a total of 7 late-stage project product across all modality. The CDMO market outlook for Cell & Gene technology show mid-teens growth for the preclinical and early phases. This increase to the mid-20s for late-stage and commercial phases, showing all this field is maturing. The complexity of manufacturing process continue to remain a challenge. We also see a clear issue with patient scale-up customized treatment, which presents a challenge for standardization and as well as repetition. This can clearly increase the cost and compromise the commercial viability of product. Again, if you have a look on the market today, at the approved treatment, variants quite often between 0.5 million and 4 million doses. And the manufacturing of this treatment is quite a challenge as well as the cost. But clearly, we see our market growth is supported by improved clinical efficiency, allowing an increased number of products to move towards late-stage and commercial, since the market growth is also driven by accelerated approval pathway. Looking across the industry, the high potential of the market is becoming clear. Certainly, we see other CDMO players are extending their capacity and speed and their scale in this space, but we are well positioned. Turning from our current business to our future plan. Let me share a couple of priorities. First, we clearly have made strong progress towards delivering a breakeven margin for Cell & Gene therapy in Q4 of this year. However, we must remain ambitious and carry the business into positive margin evolution for the years to come. Second, we want to further build on the promising growth we observed in bioscience. In particular, we want to strengthen the bioscience offering for the Cell & Gene market. Third, we must continue to maintain momentum on the path to commercialization for Cocoon. This is a critical component of our personalized medicine offering and a proper technology for the industry. We see recent -- in recent clinical trials positive outcome showing the potential of the system. Fourth and final, we are working to grow our business to leverage synergy among them. By bringing together our product and services, we can serve multiple modalities. Lonza Cell & Gene technology are driving high level of customer interest. There has been an ongoing industry challenge to reach commercial availability. Nonetheless, we have reason to be confident when looking at the operation in combination with the wider industry dynamic. Looking first at the market, there is a clear increase in portfolio of therapies. As customers gain greater visibility on the potential of commercial success on the therapy, there is a greater appetite for longer contract, which provide benefits from both sides. With more customer product ramping up volume as the product progress towards commercialization, we also expect to see fewer challenges in our facility and less changeover. This same development will also help us to achieve a more established production processes and higher asset utilization rate. Taken together, this development will increase our operational efficiency and reduce our cost, taking us further into profitable growth. Looking inside our own business, we are continuing to maintain a high standard of quality while increasing our delivery level and managing costs. All of these variables can benefit from an increased focus on process automation. At the same time, we are working to attract, develop and retain the best talent to build on our leading position. By bringing together the right team, we can clearly enhance our approach to innovation and further strengthen our processes. Having taken some time to explore our Cell & Gene technologies, let's now move into our Bioscience business. In this space, we provide clinical raw material and instrument for both discovery, research, testing and production. Our services include discovery and biopharmaceutical, biomanufacturing solution, stretching across the journey to market from gene to patient. It is another example of how we provide our customer with an integrating offering. In Bioscience, we serve multiple target market with 3 main customer community based across academia, biotech and large pharma. The third component of our Cell & Gene business is personalized medicine. This is another area with high commercial potential. Clearly, building on our experience in Cell & Gene technology, the Cocoon platform is already enabling us to push past the traditional challenges of autologous cell therapy. In such therapy, patient cells are collected, processed outside the body in our facility and then returned to patients. And clearly, the challenge of making this part outside the patient body is very critical. Clearly, it's requiring technology, which is tailored to each patient, which require a complex manufacturing process. And this is clearly costing high -- bringing high cost and cause clearly barrier for scale up. We are really pleased to see that our Cocoon technology works to manage each of these challenges. It's a closed automated system made for patient-scale therapy, and we can do that close to the bed side. Our Cocoon solution is clearly compact, portable and highly automated while remaining easy to operate through the use of customizable asset. Combined, these advantages look to set to enable scaling up of autologous cell therapy at the point of care, while managing cost and flexibility. As we progress towards the commercialization of the Cocoon platform, we have entered into collaboration with partners, which are clearly eager to establish reliable and efficient manufacturing process of their own therapy. We have close collaboration-ship with a couple of key leading hospitals. And clearly in August 2021, we were able to confirm that some positive outcome with 3 trials at the Sheba Hospital in Israel with the patient showing complete response. In the last few months, we have entered into collaboration with 2 other companies to use Cocoon in the manufacturing of novel TAC-T cell immunotherapy clearly designed to treat solid tumor. We have also entered into a collaboration with CellPoint for the manufacture of its CAR-T therapy. Again, this collaboration will help us to build on proof-of-concept for the benefit of the Cocoon manufacturing system. Moving forward, this collaboration are invaluable as we continue to ensure system for business. We have a clear ambition to build an autologous cell therapy manufacturing capability, focused on cancer and rare disease. But clearly, we are also aware that all success depend on continuing our record of clinical success. Clearly, to summarize our work on Cocoon, I would like to share a video showing all these new device can really revolutionize how the industry is preparing personalized medicine. [Presentation]

Pierre-Alain Ruffieux

executive
#7

For me, this is a clear example how we really try to make a difference in Cell & Gene. Not only being the leading CDMO by offering the classical activity, but also clearly addressing the challenges. If you will be present in a current manufacturing facility, you will see a lot of operators working under laminar flow in a very manual process. Okay, this is the best way we do, and we are good in doing that, and we're improving day by day. But we believe that it's not enough. And innovation like Cocoon has really the potential to revolutionize the way we are doing that. It's also important to understand to see that in Cell & Gene, the free offerings are complementary. Again, on one end, with the Cell & Gene, we really provide services to our customers which need that. In Bioscience, we have a dedicated offering of medium of goodies to help to do that. With the synergy by developing the process, you can develop the product and get better outcome and vice versa. And Cocoon is closing the loop. So as I presented on that, with the Cocoon capability, the integrated offering in Bioscience as well as accelerating Cocoon adoption, we clearly see a way to revolutionize this part of the business. We clearly see further natural synergies. And really, it's an opportunity to cross-sell solution and material while providing better services to the customer. We have also some additional offering in this space with the MODA electronic batch record, which clearly deliver benefit to customers in the Cell & Gene generic space. Clearly, we -- and this customer has basically one wish, it's really to accelerate the time to market while decreasing the number of mistakes and increasing the right first time. Last but not least, I would like now to turn to our Capsules & Health Ingredients division. This business offers innovative capsules, dosage form solution and health ingredients for pharmaceutical and nutritional customer. It's currently representing 26% of our group business. The Capsule & Health Ingredient division is an integral part of our offering. We deliver new and differentiated product offering and has experienced sustained level of high demand, which has turned -- which has led to high capacity utilization. Clearly, Lonza is growing above the market average in both capsule and dosage form solutions market. In our Capsule business, we are able to offer a wide range of quality capsule, which can be configured to match customer needs. Our global facility network allow us to deliver at scale at speed. Our customers also benefit from integrated support across the value chain. Our dosage form solutions business is also able to deliver end-to-end offering supported by strong R&D proposition to deliver proprietary formulation and untapped solution technologies. The health ingredient market is more fragmented, but we are again delivering above-market growth lever. Our success in this space is supported by branded health ingredient, which benefits from credible scientific claims. Looking at our service offering, we are also able to offer our customer ingredient manufacturing expertise. Similar to the other division, let's take a look at the strategic priorities for the Capsules & Health Ingredient business. First, we are already delivering high revenue across the division, but there is an opportunity to improve margin with a greater focus on high-value capsule in the future. Second, we see the value potential in dosage form solution business. We would like to drive more customer collaboration in this space to accelerate innovation and capture market advantage. Third, we will maintain our existing focus on innovation as we work toward a new and innovative capsule and dosage form solution capabilities. Alongside these strategic priorities, we will also continue to drive growth across the division by investing to expand our current offering across our existing manufacturing network. Now let's take a look at each of these priorities in turn. As I mentioned, our first priority is to ensure we are focusing on more innovative encapsulation technology. They help our customers to differentiate their offering and provide a more attractive margin profile for our business. We supply capsules for both the pharmaceutical and nutrition market, each of which have different needs and dynamics. In the pharmaceutical space, we are seeing a greater focus on how the capsule profile can be developed to support the delivery of new and more complex and sensitive medication. We are also seeing a combined focus on product quality and supply security. The nutrition market also shows demand for innovative solutions. Also, the focus is on healthy and clean-label capsules. We are able to play across both markets, thanks to a broad portfolio of products, which can be tailored to meet different customer needs. Our wide range of product are manufactured across our established global network, which maintain high quality standard. Equally relevant for both of our markets, our business allow us to offer end-to-end services as well as proprietary ingredient, technologies and services. By extending our collaboration in drug formulation services, we will continue to drive our own innovation agenda. This will help us to continue to bring new product that disrupt the market and support the delivery of a customer treatment. You can clearly see also on this picture, signs of some of the new capsule we are able to manufacture, being capsule in a capsule, minitabs or lipids microencapsulation. Looking at the current market, we see that 55% of liquid nutritional supplement depend upon tailored delivery technology. As you can see from our innovative selection of new products on the right, we are well positioned to meet current customer needs with customizable release profile, flexible release timing and increased bioavailability. We are clearly able to address these needs by staying close to our customer through the product development stage. This allow us to understand product profile and anticipate delivery needs and provide optimal delivery technologies. Clearly, our tailored approach is complemented by the global scale and reach of our drug formulation services. Our network allows us to deliver manufacturing and R&D offering while addressing regionalized demand. Finally, let's take a moment to review how we are driving innovation in Capsule & Health Ingredients, starting with the product portfolio. First, our next generation of enteric capsule is a completely new capsule technology that incorporate cutting-edge technology and protection against stomach and acid digestion. So clearly, with this new capsule, we can deliver product at any point in the body, passing the stomach or any point in the digestive system. One example is our Licaps enteric capsule technology. They can both simplify and accelerate the development of a drug product requiring delayed drug release and protection from the digestive enzymes. Second, we continue to improve our lipid-based microencapsulation technology. We are clearly embedding active in the lipid matrix as well as taste masking for functional food and drink. We are also able to customize the release profile and, hence, bioavailability. Turning to our service. We are continuing to invest in expanding our drug formulation R&D offering by establishing a new application lab. We are working to ensure that capsule continue to consolidate their position as a leading dosage form for our customer. Finally, our operational advancements will also support our offering. Our new D90 capsule manufacturing machine will improve output while reducing deviation. Importantly, it can also be configured for a wider range of production output to ensure we can meet every customer need. On that one, I would like really to stress that in the opposition to our competitors, we not only manufacture capsules, we also manufacture the equipment to manufacture capsules, clearly providing us a competitive advantage of controlling the full value chain and providing big advantage in our offering. As all 2 of the division draw to a close, I would like to take just a few moments to share some final remarks. After that, we will take a short break before returning with -- for the Q&A. I am sure that it's really clear at this moment that we have -- we are writing a new chapter in the Lonza story. We are clearly now a pure player and a strategic partner to the industry, health care, providing CDMO services to the pharma, biotech and nutrition market. Across our divisions, we have a portfolio of high-value offering, which are supported by a firm commitment to innovation. Taken together, our approach to value and innovation are allowing us to consistently deliver above-market growth in our division. Looking forward, our investment plan have been developed with care and consideration. Clearly, we want to capture the market advantage and accelerate our growth. All our future plans are supported by our consistent and continuing focus on customer delivery. Our midterm guidance reflects this combination of current performance and future ambition. Clearly, we believe that we have all the building block are in place, and we are well positioned to deliver. It's why we are really focusing on operational excellence. This is clearly bring us to the end of the formal presentation. I hope we were able, as started last year, to provide more transparency on our different businesses. All we focus not only on increasing scale, but also expertise and perhaps even more importantly, innovation. As you can see, we believe that innovation is bringing us a competitive advantage to drive future growth as well as increase margin in the future. This is clearly bringing us to the end of the presentation. I would like to thank you for your attention, invite you for a short coffee break and bio break, and welcome you back in 15 minutes for the Q&A session with Rodolfo. Thank you.

Operator

operator
#8

[Operator Instructions] We will start first with some questions on site and then switch over to the phone. [Operator Instructions]

Pierre-Alain Ruffieux

executive
#9

Okay. So let's start with the room for around 20 minutes.

Richard Vosser

analyst
#10

Richard Vosser from JPMorgan. Maybe 2 questions, please. Just one on the margin guidance here. I think, Rodolfo, you said pushed out, but just thinking about the 2023 margins. Originally, that was 33% to 35%. Should we anticipate you still being able to reach the low end of that range in '23? And then second question, just on the contribution from commercial fill/finish biologics to the top line, should we anticipate that clearly probably beyond '24, but is that upside to your anticipation of acceleration? Or is that included in the acceleration? And just when we think about those projects, is there a high level of risk? How are you -- how is the conversations with customers in terms of getting those contracts signed?

Rodolfo Savitzky

executive
#11

Yes. So not too long ago, we were talking about the previous midterm guidance. And we said we completely confirm the prior midterm guidance. Now we will now move into the new one. But that means definitely our margin trajectory will hit the original guidance for 2023. So I think this answers your question. Now going forward, we will only talk about 2024 because otherwise, we end up with 2 guidances, which doesn't make sense. Now I think in the commercial fill and finish, again, this is a priority for us and likely you would hear about more concrete next steps in this priority area in the coming, let's say, coming months. Therefore, you would expect that the impact would be rather towards the, let's say, out part of the midterm guidance. So far, our expectation is that projects in this area would be, let's say, following a similar risk/return profile and margin profile compared to what we currently have in the portfolio.

Pierre-Alain Ruffieux

executive
#12

And perhaps to provide more color. As you have seen, we are very clear to drill this capacity starting with the value chain, formulation, clinical, making future investment, and we are in a strong trajectory. And yes, we will see if we can accelerate that with some M&A. But we are very clear on building this capability. And again, creating trust with customers, gaining early projects in clinical development, this is the way we develop business. Next question, please? We have one -- first line?

Jo Walton

analyst
#13

Jo Walton from Credit Suisse. Two questions, please. The first one is, are there any areas of your business where you're seeing it difficult to get a return, a ROIC of 30%? Because that's a very high return, and there are lots of people trying to get involved in this industry. So are you finding areas where there's price competition beginning to come in and making it less attractive for you to do investment? And the second question would be a bit more about your Moderna relationship. You've clearly gained a lot of experience with them in mRNA. Is there any degree of exclusivity of areas? Or -- you mentioned you've got 200 drugs out there that you could see you might get involved in. How does that work with Moderna? And how should we think about Moderna as being what sort of percentage of your business going forward?

Pierre-Alain Ruffieux

executive
#14

Okay. So for Moderna, we don't have an exclusivity agreement. So we can work with others. To be clear, what I mentioned, 2 entities, not 200 customer we have. It's a survey we have done, and we see more than 200 component in development, underscoring the attractivity of this field and future opportunity. Regarding margin and competition on price, I think it's important that you have probably seen that today. I think Lonza [ is like ] CDMO. We are active in high end, difficult to make, which is why a lot of technology and investment. So again, to oversimplify, we are not really active in making tablets or making simple things. So in theory, we are. Yes, we see an increased competition, but we don't see at that stage challenges on the cost or competition for cost. At the same time, we are underscoring the need for continuous improvement. And yes, to stay competitive in this market, we always need to be better, both on our operational side but also on the performance of our product. And this is the way where we keep our competitive edge.

Rodolfo Savitzky

executive
#15

Maybe just to complement the question on the ROIC. When you look at the growth projects, of course, to an extent, the contribution of these growth projects, it's marginal in the sense that you don't need to have a full overhead base to support these growth projects. So the type of ROIC we see once you have reasonably ramped up sales is very high, right? So when we guide 30% plus, I have no concerns that for the vast majority of the portfolio, we will achieve these levels of ROIC or even higher in some cases.

Peter Welford

analyst
#16

Peter Welford at Jefferies. So couple of questions. Firstly, just on the margin for Biologics. You delivered a margin of 39% on Biologics, I think, in 2020. Obviously, that then declined due to the investment and the expense, obviously, for the new projects. I think you've guided for 35% EBITDA margin in 2024. Can you give us some idea, I guess, of the trajectory from 2024? Is it still feasible, I guess, partly coming back to Jo's question, to get to the high 30s, 40%? Is that something we should be thinking of? Or is, I guess, the mix changed such that we should be thinking of a difference to the long-term EBITDA margin potential for Biologics? Second question then is just with regards to cell and gene therapy. I think you talked about the market growth being at least 15%, I guess, a bit down about -- you talked about at least 20% in the last CMD. Is there some conservatism built in this in terms of -- I know there's a lot of projects in development, but there's also been a lot of setbacks as well in cell and gene therapy recently. Any thoughts in terms of how -- how are you thinking about this space in the sense that there's obviously a lot of projects that it must be very hard to risk adjust how many may actually ever become a commercial significant reality for your business.

Pierre-Alain Ruffieux

executive
#17

Thank you. Do you want to take, [ Martin, ] for the first [indiscernible] one.

Rodolfo Savitzky

executive
#18

Absolutely. For your question on Biologics margin, first, an important distinction when I shared the guidance, probably, I used the word above. And then when you see it in the slide, we talk about in the space of Biologics 35% plus, right? And we didn't plus -- put the plus by accident. We really mean above -- a couple of notches above 35%. Yes, fair enough in the H1 2021. Even we can go to more recent performance, the margins in Biologics were around 38%. We said we expect, in general, in the second half, margins will be lower than in the first half. That's what we shared. So we will come with a certain base at the end of this year. And from there on, we expect, as I said in the presentation, a trajectory of improved margins. But of course, Biologics is reflecting the short-term impact of this increased level of investment behind mainly CapEx, but the CapEx comes with OpEx, right? So this is a natural evolution, I would say. You saw the business model that I described. If we would peel off the growth investments, of course, the margin shows quite an uplift. But we're investing behind the future, right, and that's part of the model.

Pierre-Alain Ruffieux

executive
#19

And regarding your question on growth in cell and gene therapy, again, we make a differentiation what we see in the market. Our own growth -- and again, our own growth is probably above the 20%. At the same time, I think it's always depend which part you take. If you have a look on commercial product, I think we are the first CDMO to have a commercial product on the market. So it's quite high growth to go from 0 to 1. But joke apart, we see a lot of product now in late stage and ready for commercial approval. So we see an accelerated growth in that part. And you -- as you see properly, a lot of pipeline coming, but also a lot of variability because we've seen this field multiple failure. So as we have guided or discussed in previous investor call, we really see a maturing of this industry up to recently. It was [ early ] development program, clinical phase, and we see that maturing, also driving some of the increased margin. But definitively, a very strong growth in the market, 15-plus percent, and definitively us capturing a significant part of that. But the numbers are showing some volatility definitively. Next question, please. We have one here in the middle and then on the front line here.

James Quigley

analyst
#20

It's James Quigley from Morgan Stanley. Two questions. So in the slides, you mentioned about the post-2025 outlook as well and the growth potentially being or accelerating compared to the midterm guidance. So how sustainable is that in the post-2025 period versus the capacity or the capacity utilization increasing in the new investments? So is it a case that 2025 is higher than the midterm guidance, but actually from 2026 onwards, it dips below as the base increases? And then how should we also think about how the CHF 1.3 billion or CHF 1.5 billion of CapEx a year would impact your growth beyond 2025? And then again, on the guidance, what are you assuming in terms of the competitive situation across Biologics, Small Molecules and particularly in an area like ADCs, where there's been a lot of interest from Merck and other companies as well in that area?

Pierre-Alain Ruffieux

executive
#21

So first, regarding the guidance, we are speaking today about 2024. And really what we have tried to show, the growth rising between today and 2024, it's coming from investments we have made in the last 4 years. Because for me, a key message is really this cycle, it takes 3 to 4 years to build an asset, and it takes 2 to 3 years to ramp up the asset. So obviously, today, we are not commenting for what will happen after '25. But I let you make the math with the investment we are doing today. And at the time they will mature, we will see what they deliver. Here, I think we are providing 2 key information consistently year-over-year. It's, first of all, we secure investment long term. So we make sure we have some anchor customer, not to finish to build up and to have nobody. And second, we provide in the past a kind of rules of thumb but across the business, CHF 1 invested is providing perhaps CHF 1.1 in sales when we ramp up. But we don't comment later on -- post '24, sorry. Regarding ADC, clearly, I think it's what I was showing in my presentation. I think Lonza was the first mover in this field, collaborating more than 15 years ago with Genentech at this time. And clearly, we have a leading position in this field. And yes, we see more and more company trying to do that, trying to bring innovative product on the market. And here, it's quite complex. You need to make antibodies. You need to make the toxin. You need to make a linker, and you need to combine everything together. So quite challenging technically. But on top of that, you need to do it the right way to get approval from health authority. And here, we believe that our expertise or scale is bringing us a competitive advantage. Next question on the front line, please.

Daniel Buchta

analyst
#22

Daniel Buchta from ZKB. Maybe the first one to you, Rodolfo, on M&A. Very interesting comment on the couple of billions which you mentioned. However, how does that fit together with the relatively rapid ROIC acceleration or appreciation you expect from these investments given the meaningful amount you intend to spend still? The M&A multiples and prices are not low. And how can you expect that to support the ROIC in the next couple of years? And then maybe a broader question on your site in Visp. I mean you have shown the very interesting Slide 15 with the different projects where 2 sites are still green. Is there still expansion potential beyond that in Visp? Or is this full then? And also how does it work with hiring staff, given there's still quite meaningful expansions in the next couple of years? I assume the site and the area is empty already.

Pierre-Alain Ruffieux

executive
#23

Rodolfo, you start with M&A, and then I will take service one.

Rodolfo Savitzky

executive
#24

Yes. Happy to provide some perspective. Here it's difficult. I mean it's a difficult question because on bolt-on M&A, of course, it's a case-by-case situation. I think what is important for us in general is to try to find opportunities where there are clear synergies with the -- let's say, with our current business. And that's what brings a ROIC accretion. Again, you wouldn't get the ROIC accretion immediately. I wouldn't like to now lock myself in a specific year, right? But I could say that our expectation that definitely in the first couple of years, most bolt-ons will not be accretive. But hopefully, year 3, 4, afterwards, we'll start seeing meaningful accretion to our ROIC. This is how we -- we have a template, if you want, but the template is very nice theory. In M&A, you need to manage it on a case-by-case basis. But I think what is important though is that we have a very disciplined approach, and we wouldn't shy away from turning down an opportunity if we think it's, first, definitely not the right strategic priority. That for sure would rule it out. But if we find that the financial metrics are not the right ones for -- based on our guardrails, then we will turn them down.

Pierre-Alain Ruffieux

executive
#25

And clearly, to underscore, we -- as we say, we always evaluate buy versus make. And when it's about capacity, generally, the business case is relatively clear. With a capability to build, it's quite a strong business case. And for technology, we have shown in the past, being an early adopter, we can create much more value internally, taking the example of bioconjugate or mRNA. Again, still, we are apparently scanning the field. Now 15 years ago, when we entered bioconjugate, perhaps not so many people were excited, and we do that. So there is a lot of value to master technology, to be ready when the customer needs it. Regarding Visp, again, we don't speculate about future investment until it's time to do. But a couple of things to underscore. First of all, we have explained or we like to be close to the market and to the customer. So for every new investment, we will have a look, is it better in Europe, in the U.S. or in America or in Eastern part of the world, point #1. People is always a challenge. At the same time, these projects are quite long. And we have demonstrated our capability to attract people. So again, I would not underplay it, but it's something -- we know how to do it. And when you make long-term investments, 3, 4 years until you need many people. I think we have proven track record to bring that. We are not concerned of having space. We have big large locations, large piece of land. And if at one stage, we need to buy extra, I'm sure we will find solution. But really, we try to balance the investment based on the customer need, location as well as technologies. Next question, please. I think we have one here and then on the front line.

Unknown Analyst

analyst
#26

[indiscernible] I just had a real quick one to follow up on M&A. You spoke of value chain, regional presence and short-term capacity. And then you've also spoken about synergies. I just wondered if whether or not you'd look more broader field in CROs, research services and elsewhere to [indiscernible] a lot of capacity.

Pierre-Alain Ruffieux

executive
#27

Okay. If I understand properly, you speak about our appetite for clinical research services. I mean it's not really our field of activity. Again, I would never speculate. But if you see what we are good at and why we really try to develop its services around manufacturing or early development to commercialization. Clearly, some of the specificity or high entry barrier, you would probably find less in CROs. So again, I will not speculate, but it's probably not fitting with some of our key items. One question on the front line, and I think then we will move also on the phone for the next question.

Patrick Rafaisz

analyst
#28

It's Patrick Rafaisz from UBS. Two questions, please. The first on CapEx. And you again mentioned that relation $1 spent is $1.1 of revenue, right, at one point in the future. But currently, until 2025, you're spending much more, of course, as a percentage of sales, then you're growing. So how should we think in the very long term? Will there be a reversal where you will be growing faster than CapEx? Or should we think about new bigger projects, for example, significant expansion in China to come after 2025 so that CapEx will remain in that elevated high teens territory even then?

Pierre-Alain Ruffieux

executive
#29

Again, as mentioned before, we are not going to speculate. What we say today is really the growth you will see between now and 2024 is really coming from past investment and we guide on the growth we will see. Regarding of CapEx, currently, we see nice opportunity. And I think it's why we are guiding with this higher than historical value of CapEx more in the 25% range, going down to high teens. But again, I will not speculate, I will say in 4, 5 years from now, if there is, again, a lot of very good opportunity, we can see an increased CapEx to capture things. If there is less, we can see the CapEx going even lower. So at this stage, I think it will be inappropriate to speculate. Clearly, our rules are: make sure when we have investment, we have anchor customers, so we derisk it; make sure it's fulfilling some financial criteria that Rodolfo [ has spelled out before. ] And if we are able to do that and we see it's attractive, we will go for it. Otherwise, we will wait for a better opportunity.

Patrick Rafaisz

analyst
#30

And the second question was a follow-up on mRNA. Can you give us some quantitative indications, right? I mean if you assume your Moderna collaboration will be the baseload for mRNA-related revenues in 2022, thinking of the 2024 targets, will mRNA grow from that base? Or will it maybe decline and then grow after 2025 again? Just some clarifications. And I also noticed you're anticipating in-line growth with the markets, right? I would have expected maybe you have faster growth given that you have almost an early mover advantage in this field.

Pierre-Alain Ruffieux

executive
#31

Yes. On the second part of the question, it's quite easy. In-line growth with the market, making mRNA vaccine, I think we are probably the only or one of on early CDMO doing the drug substance part. So it would be difficult to grow faster than we are growing. We don't provide numbers and detail on the different division and the customer. Clearly, what we see in the mRNA, which is quite interesting -- now mRNA was first published in late '90s. For the last 10 years, we have seen a lot of clinical trials and development. And really, the vaccine and the COVID-19, it shows the feasibility of this technology, and this is underscored by the high number of product we see in early development. I think we are all familiar to the success rate of pharma. So we will see a lot of failure, I have no doubt, but we will see also some success. And familiarly, what I see, it's a very promising technology where you use the human body to produce a molecule instead of doing it outside. So I think we are pleased to have key player in this field. And I will not speculate what is the trajectory for the next 2 or 3 years. But I see this technology really, really promising for the future and great business opportunity. With that, operator, we will take the first question from the line, please.

Operator

operator
#32

The first question from the phone comes from Peter Verdult from Citi.

Peter Verdult

analyst
#33

Peter Verdult here from Citi. Three questions, please, on the guidance, ROIC and the competitive landscape. Maybe kicking off with Pierre-Alain or Rodolfo, can we [ explore ] from the upsides to your midterm revenue targets? I realize you can't detail every assumption, but I am interested in what you assume with respect to mRNA COVID vaccine booster programs and -- [ outside of ] antibodies. Any general comments you can make there? My second question, Rodolfo, is on ROIC. You gave the roadblocks during the presentation and the Q&A. Could I just perhaps ask for a clarification? I mean going forward, will Lonza shift more capital to wholly owned and operated manufacturing asset plants and less to sort of the risk-sharing projects you've done previously? Just want to make sure I understand that correctly. And then pushing you on the group level, you talked about double-digit ROIC. But from -- Rodolfo, can I ask to push you into what that really means in your internal plan? Are we talking 20% to 30%? Or could that growth levels go higher? And then last week, Pierre-Alain, just on the competitive landscape, as it relates to mRNA, bioconjugates, cell and gene therapy. I think you have a first mover advantage, but perhaps you could detail a bit more how much [ really ] differentiation you have in this area versus your known competitors from Asia and Germany?

Pierre-Alain Ruffieux

executive
#34

Okay. Peter, we will try to answer your question. Unfortunately, for 2 of them, the 2 first ones was, at least for me, difficult to -- I will start with the last one, and perhaps we will see what we have understood here. And perhaps for the techniques, if you can just make sure it's a little lower [ it will be better. ] So regarding the competitive advantage we have in mRNA bioconjugate and the presence worldwide, again, I think there is a couple of criteria, which are a key for our success. First of all is since then, are we active in this field? Do we have proven track record? Again, it's always important to take the perspective of the customer. A customer will invest a lot of money in clinical trials, and what he want is confidence and minimize the risk in manufacturing material for clinical study, but also getting approval for launches. So again, the technology is very difficult to master. But on top of that, you need to have the regulatory track record. And we see that very strongly with bioconjugates. And while we take every competitor very seriously, I think we believe we have leading advantages. mRNA, it will be arrogant to say we have much more experience because it's quite fresh. But again, I think we have a first mover. We have shown capability and we have learned also a lot in this time, dealing with multiple health authority on the regulatory aspect. So again, we believe there is a strong advantage. Are we going to see competitors from different places and as you mentioned from Asia, too? Yes, for sure. But I would say we have seen that in many of other business for the last 20 years. And we believe by continuing to focus on innovation, providing value, we are in a good position. Rodolfo?

Rodolfo Savitzky

executive
#35

I have to say it was very difficult to understand, at least for me, the questions because the sound was cracking. I believe, Peter, that, number one, you talked about the assumptions related to mRNA as it relates to the guidance. Is that right?

Peter Verdult

analyst
#36

Listen, I will try once, but if the line is bad, move on to the next question. I was just looking for potential upsides. What do you assume on mRNA booster vaccine [ outside of ] antibodies?

Rodolfo Savitzky

executive
#37

Look, you -- one thing we should remind ourselves, we -- our business model, again, is the CDMO business model. So when we talk about, for example, a topic like mRNA, and I would now go into a little bit the COVID-19 vaccine. One thing is the, let's say, the pharmaceutical company, and they need to deal with demand and how to best meet that demand. From our side, we follow the model of having secured contracts in general. And that means that the level of planning in our midterm guidance is quite predictable, right? We have certain commitments from our customers. So I think Pierre-Alain mentioned already some of the attractiveness of the mRNA space and potential upside bit. So I would not comment on that. But just to underscore that when we talk about some of our projections there, let's say, supported by existing contracts with our pharma clients. I think there was a question, Peter, number three, question number three, about the ROIC. And you just wanted to clarify the -- what double digit meant? Is that the question?

Peter Verdult

analyst
#38

[ Yes, please. ] The delta basically, what does double digit mean? I wanted to clarify, going forward, is Lonza going to be spending more of the capital on wholly owned manufacturing plants and shifting away from the sort of risk sharing [indiscernible] collaborations of the past? Can you please clarify that -- and push you on what double digit actually means.

Pierre-Alain Ruffieux

executive
#39

I think the question was capital sharing with some of our customers.

Rodolfo Savitzky

executive
#40

Well, the model -- again, I think one of the beauties in terms of the way we operate is we have very flexible commercial contracts with different customers. I mean we have highlighted that our commercial flexibility is part of our competitive advantage. So in that sense, we offer different possibilities. If there's capital sharing, of course, that translates into different revenue streams. If there's -- if CapEx is fully funded by Lonza, then, of course, the associated revenue is higher. So in that sense, we will continue to be quite flexible. The expectation is that the CapEx sharing model or the commercial model that we have on average in aggregate will remain the same. And this is built in the ROIC projections.

Operator

operator
#41

The next question comes from Patrick Wood from Bank of America.

Patrick Andrew Wood

analyst
#42

I'll keep it to 2, please. The first one would be, appreciate you said it's difficult to speculate. But you did call for CapEx sales to drop down to the high-teens level as time progresses. I guess, is there something that's making you feel you want to lower the cadence of capital deployment? Or is that just conservatism on your end? Is there anything making you feel like you would want to drop down proportionally the investment over time? So that's the first question. Second question, you called out lots of different efficiency measures and things you can do. I'm just curious, if you have to flag one thing on the production side, I don't know whether it would be perfusion or downstream purification or whatever you like, what will be the one thing you think is most ripe for efficiency gains to drive better throughput through your facilities over the next, I don't know, 5 years or so?

Pierre-Alain Ruffieux

executive
#43

No. Thank you for the question. So regarding the capital allocation, I think it's important to see from where we are coming and where we are today. So again, moving from a 15%, 16%, 18% to 25. 20% is very high, okay? Again, it's supported by very nice opportunity. The reason of the guidance going down, we are not sure we will see this kind of growth forever. But again, as I mentioned, we will be smarter in a couple of years from now, and we will see what are the opportunity. And again, if there is great opportunity, we know at that time. So again, it's why we say we don't speculate. Regarding continuous improvement opportunity, historically, we have seen a lot of opportunity in the production part. So expressing more protein with the cell line. We see, without going too much to the detail, that with perfusion, we can continue to increase that. We see multiple opportunities, and this is really driving it. The second point I will mention is really utilization of equipment. There is still a way to optimize changeover, tech transfer and all these kind of things. So we see the 2 biggest opportunity. You mentioned downstream. I think downstream, it's a part of the process, which has not changed a lot for many years. A lot of comment is from the chromatography technology used. And yes, there is some opportunity there, but I think we are more limited by technology, but we explore it.

Operator

operator
#44

The next question comes from Paul Knight from KeyBanc Capital Markets.

Paul Knight

analyst
#45

On single use, are you investing proportionately more in single-use? And does single-use allow you to get to market faster? Does it allow higher potential EBITDA margins?

Pierre-Alain Ruffieux

executive
#46

No. Paul, thanks for the question. We really see single-use and large-scale stainless steel as complementary solution. Again, single use are a little less expensive than large scale, obviously, but they provide also less capacity. We see a lot of early-stage development in single-use. And then depending on the market demand, you may keep production in single use at 6 cubic or then move to 20,000. Again, depending on the type of proteins, the type of customer, and I think we split that in terms -- proportionally probably in both. But in terms of Swiss francs amount, large scale, they require more capital -- more investment. But it's not a question of religion one versus the other. We see we need both to be successful.

Paul Knight

analyst
#47

Okay. And then the other question was, when you have projects that you're building out, you mentioned derisk. Is it half of your capacity you feel like you have booked? Or what's the level of commitments you view as having a derisked expansion project?

Pierre-Alain Ruffieux

executive
#48

Okay. No, thanks for your question. It really depends on the type of asset. Again, we communicate -- we don't commit exactly the detail, and there is not a fixed number. But for 6 times 20,000, it's much, much more than 50% you mentioned. For example, if we will put in place a facility with disposable for clinics, obviously, the derisk will be more based on the pipeline of customers because they don't have long-term commitment. So again, it will depend on the type of technology with the customer or with the pipeline of customers.

Operator

operator
#49

The next question comes from Deng Xian from Berenberg.

Xian Deng

analyst
#50

I have 2, please. The first one is, I was just wondering if you could have any comments, assumptions of Alzheimer's opportunities included in your midterm guidance? And just wondering, how do you manage the risk here? Because this is sometimes not even rely -- residing with the customer, but actually residing with the regulators. The second question is that I was just wondering, in terms of cell gene therapy space, I wonder if you could comment on the competitive landscape for the cell and gene therapy CDMO space. And what is your sales split between the early stage and commercial stage, please?

Pierre-Alain Ruffieux

executive
#51

Okay. So I will take the second one. It's relatively easy for the commercial phase. I think we have one product commercially today, which looks little, but it's more than most of our customer -- of our competitors, sorry. We clearly see a maturing of the portfolio. So for years, many companies has been conducting clinical study. We see more and more product close to commercialization, but there is still things to do. As a policy, we don't comment so much on competition. So I'll let you have a look on who is active on this field. Rodolfo, you want to take the one on opportunities?

Rodolfo Savitzky

executive
#52

Yes. So a couple of thoughts there. So first, let's start with your second part on the first question, the risks. And here, what we have mentioned several times, to a great extent, our sales projections are underpinned by contracts. In other situations, Pierre-Alain mentioned just a moment ago, we have very clear pipeline for some our clinical sales. And so I would say the level of risk overall in the projections, I would definitely qualify as low. Again, a lot underpinned by long-term contracts, high levels of pipeline. Now on the opportunity side, again, and this relates back to the question of CapEx investment over time. If I just give a simple example, Alzheimer's. This is not part of our midterm guidance projections. We haven't included an upside related to an approval of a new Alzheimer's drug. So if something like this would happen, definitely, this would be an upside. What it means for Lonza, we shouldn't speculate at this point in time. But my comment is, in general, if I have to characterize our financial projections, they are more towards having a potential upside rather than a downside. Again, we cannot exclude operational issues that could translate into some delay in sales. I mean negative things can happen as well. But in general, I would say it's a model that has much more opportunities up than risks given just the nature of the model.

Pierre-Alain Ruffieux

executive
#53

I think to be aware of the time, we will just take now the last question, please.

Operator

operator
#54

Sir, so far, there are no more questions from the phone.

Pierre-Alain Ruffieux

executive
#55

Okay. So I would like really to thank everybody for your attention, for being present here in Zurich or over the phone, and I wish you an excellent end of the day. Thank you so much. And for the people present in Zurich, we are very happy to invite you for a small [ operative. ] Thank you.

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