Lonza Group AG (LONN) Earnings Call Transcript & Summary
October 17, 2023
Earnings Call Speaker Segments
Albert Baehny
executiveGood morning. Good morning, ladies and gentlemen, and welcome to Lonza Capital Markets Day. A warm welcome also to those who are joining us remotely. It is also my privilege to introduce the Lonza Executive Committee. We want to make sure that we make the most of our time together today. This morning, we will start by sharing with you the fundamentals of our business and strategy. Our agenda allows time for us to answer your questions and address your concerns. This afternoon, we will have the pleasure of hosting you on the Gate 2 of our facilities here in this Visp. I will start with a short introduction. My aim is first to reassure you that we have listened to your views, questions and concerns. Second, I want to share with you the fundamentals of our business and strategy and the highly attractive industry we operate in. Third, I would like to set out our strategic priorities at the group level. Lastly, I can reassure you that the process of appointing a successor is underway. We have heard a number of key concerns from you in recent weeks and months and we would like to thank you for your constructive feedback. Capacity overbuild is a risk that we always watch closely. However, we continue to see a strong and sustained demand with limited risk of overbuild. Turning to the pandemic. We saw that COVID-related business led to unusual levels of high volatility. This means it is a challenge to compare our recent pandemic business to a normal operating environment. The supply chain disruptions arising from COVID amplified the business volatility with overstocking during the pandemic, followed by the subsecond destocking process. It is also obvious that this COVID vaccine business could not present a long-term secure annual revenue scheme. We have seen some biotech funding constraints, which have an impact on our preclinical and clinical Phase I business organic growth rates. We see these weaknesses as temporary in nature. The Cell & Gene Technologies remain an emerging business and therapy area. While these offerings are currently generating lower margins as expected, we remain confident in their long-term commercial and therapeutic potential. In this context, we will continue to invest in the future of this important modality. Our capital allocation strategy is one of the most important factors in defining our future success. I want to assure you that our CapEx investments adhere to a disciplined and robust investment criteria, clear financial threshold and strong governance. In keeping with our capital allocation priorities, we initiated a CHF 2 billion share buyback program as a way of returning excess capital to our shareholders. We have also resolved to increase our dividend payout from 25% to a new range of 35% to 45%, and we maintained a very disciplined approach to M&A. Finally, I would like to talk about our business leadership. Having taken the interim role of CEO in recent weeks, I have been privileged to work alongside the executive management, I am confident that we have a strong team in place. Having addressed some of your concerns, I would now like to remind you of the unique position held by Lonza in the CDMO market. We are a global leader delivering sustained and profitable growth in a highly attractive industry. Our global leadership position and growth outlook are supported by a combined focus on innovation, technology and organic investments in areas of high potential and sustained demand. The broad and sophisticated portfolio of critical modalities that help us bring new drugs to the market quickly and securely. We also benefit from our close customer relationships underpinned by long-term contracts. Our relationship with our customers is strengthened from clinical Phase II onwards. After this phase, it is a challenge for our customers to move to another partner without triggering a long, expensive and high-risk technical transfer process. The importance of our role is also built in our ability to deliver additional critical CDMO services along the drug product development value chain. Finally, our investment projects are managed carefully to ensure they deliver strong returns. Turning from our business to our market. We continue to operate in a resilient and growing industry. Constant innovation and new technologies support the health care industry's capability to treat an aging global population with rising chronic diseases and the trend towards personalized medicine. Large pharma and small biotechs focused increasingly on discovery, meaning CDMO partnerships are becoming an integrated part of the health care business model. We are seeing a growing pipeline of complex molecules and new technologies like high potent APIs, ADCs, CAR-T, bispecific antibodies, gene therapies and mRNA. These are all leading indicators of a strong and increasing need for CDMO services, know-how and manufacturing capacity. The market primarily competes on quality, expertise and reputation whereby price is a less important criterion for a selection of a CDMO partner. Finally, high risks for new market entrants include a combination of capital intensity, technological capabilities, long-term customer relationships and strict regulatory requirements. We look at our growth projects from different angles at different levels. Let me start with a few general comments. Maria and Philippe will provide further details on growth projects later. We invest around 70% to 80% of our annual CapEx in growth. This means the remaining 20% to 30% is targeted at infrastructure and maintenance to ensure a continuing efficient and safe operations. I already mentioned that we have a robust investment criteria with two key thresholds, an IRR of 15% and a ROIC of 30% at peak sales. From a risk management perspective, we have two types of long-term supply agreements. First, we have agreement with a minimum commitment fixed with a take-or-pay type of contract for our multipurpose assets. Second, we have contracts with termination fees for long-term supply agreement for dedicated assets like the deal with Moderna. We understand that sustainable value creation can only be delivered through responsible business and through a continuing dialogue with our stakeholders to understand their expectations. We have structured an approach to sustainability by focusing on the seven UN sustainable, sorry, development goals that are most relevant to our business. We have developed cliometrics in these seven areas, and we have incorporated these targets into our remuneration structure, so every employee is incentivized to support our progress. Looking at our group strategy, we have defined five strategic priorities. The first is innovation. Looking over the horizon, anticipating where our customers will need us next, building IP and protected capabilities, innovation is at our core. The second is collaboration. Partnering with our customers early in the drug development cycle allows us to participate along the full path to commercialization with tailored solutions. This enables us to become a mission-critical part of our customers value chain. The third is service. We understand that customer retention depends on consistent quality of service and robust supply delivery. The fourth is performance. Our approach to operational excellence is supported by a culture of continuous improvement. The fifth is finally value creation. This is about maintaining a disciplined approach to capital allocation while delivering for our shareholders, stakeholders and society. As I close, I would like to introduce our Executive Committee, all of whom will be presenting to you today. Now we'll ask Philippe to come to the stage and share the financial update. Philippe, over to you.
Philippe Deecke
executiveGood morning, everyone, and thank you for the introduction, Albert. Based on recent feedback from analysts and investors, today is really the day to give us the opportunity to provide you more insights and more detail about our business. So let's dive right into it. Looking at our group business, we remain confident in our current performance and future growth. We continue to pursue our strategy to drive long-term value creation for our customers and our stakeholders by investing into production assets and technologies for the pharmaceutical, the biotech and the nutraceutical industries. In my presentation today, I will start with a brief review of our historical performance before looking at our new midterm guidance for 2024 to 2028. I will also share more details on the key factors that underpin our high confidence in our midterm guidance, namely our growth asset portfolio and our commitment to operational excellence. I will summarize our view on our capital allocation strategy before concluding with an update on our Q3 2023 and outlook for 2023 and 2024. So let's go. Looking at our company in numbers, our business is built on strong fundamentals, meaning that we are well positioned for future success. We work with more than 1,000 molecules, serving a large and diverse base of around 800 CDMO customers. Our business is supported by a solid portfolio of growth projects. And our overall CDMO business is predominantly in commercial production, which accounts for around 70% of our CDMO business. I will share more about our project portfolio in a moment. As you can see, these company fundamentals have delivered a healthy financial track record and more this on the next page. Over the last 4 years, our business has demonstrated strong and consistent levels of growth. Between 2019 and 2022, we delivered a 16% sales CAGR in constant currency. This growth was driven by the combination of a healthy base business with steady growth and good margins alongside the ramp-up of our new assets. Looking at our divisions, all grew ahead of their respective end markets, and my colleagues will talk you through that in a moment. Part of our growth in this period also came from our pandemic-related mRNA sales, which reached their peak in 2022 with around CHF 0.5 billion in sales. It's important to note, however, that our growth, excluding COVID-related mRNA sales was in the low to mid-teens over the same period. We grew core EBITDA by 1.5x in that period, improving margins by 1 percentage point despite dilution from asset ramp-ups and the recent inflationary impacts. We achieved this by improving our product mix, driving operational excellence in manufacturing and through a disciplined approach to overheads. Now let's turn to our new midterm guidance for 2024 to 2028. We have decided to guide for a slightly longer period than before as we run a long-term business with extended investment cycles. Looking to 2028, will allow us to see more of our investments deliver on their growth potential. Over the next 4 years, our CapEx program and our focus on high-value offerings will continue to support our double-digit growth. Our sales CAGR is expected to be between 11% and 13% in constant currency over the period. Our core EBITDA margin will improve continually to reach a range of 32% to 34% in 2028. This will be supported by the ramp-up of our growth projects, the maturing of our Cell & Gene business and continued delivery on operational excellence of our continuous improvement program launched in 2022. We are also pleased to confirm our commitment to maintaining a strong investment-grade rating, we have a strong balance sheet and we are giving -- we are guiding for our leverage ratio to be in the range of 1.5 to 2x. Let's dive a little deeper into how our divisions will contribute to our midterm guidance. My colleagues will provide further details on the key drivers of growth and margin in their sessions. This slide provide you with a summary overview of our divisional expectations. We are not planning to introduce yearly divisional guidance going forward, but we wanted to share the midterm dynamics at play across our different businesses. All our divisions have defined a clear business strategy. And in every case, we expect their growth to continue to meet or exceed their respective markets between 2024 and 2028. Biologics remains our major growth driver and is expected to deliver mid-teens growth with margins above 35% by delivering a complete and integrated CDMO offering. Small Molecules is capturing value in attractive segments of chemical APIs and is expected to continue its mid- to high single-digit growth trajectory with sustained margin at more than 30%. This will be supported by a continued focus on expanding the highly potent API offering and ramping up new capacity. Cell & Gene. Cell & Gene's focus towards commercial production is expected to lead to mid-teens sales growth with margin gradually closing the gap with the Lonza Group average by the end of the period. And finally, our Capsules & Health Ingredients division will build on its offering for high-value standard and innovative capsules as well as dosage form solutions to grow its top line in the low to mid-single digits. The focus on operational excellence, together with new production technology will lead to margins at or above 30%. Give me a second. The revenue growth bridge on this page breaks down how we will deliver continued double-digit growth. While all divisions will contribute to our growth, our Biologics division will remain the significant driver and with around half of the growth backed by existing commercial contracts in new assets. Our CDMO order book is strong with more than 60% of our sales for the next 3 years already signed or backed by a very strong pipeline of opportunities. We also want to share the main drivers of our margin improvement. There are four key items worth highlighting. First, our growth projects will become more profitable as they reach peak utilization, and we have comparatively fewer projects in ramp-up in the later part of the period. Second, within Cell & Gene Technologies, the revenue share of commercial products in the portfolio will shift from 25% to 70%, supporting an increased margin profile. Third, productivity gains in CHI will be driven by new machine technology and margin improvement in the dosage form solutions business. Finally, productivity gains across our CDMO business will be supported by our focus on lean operations and continued operating leverage from diligent overhead cost control. Taken together, we have a solid plan in place with multiple contributors to deliver our new midterm guidance for both the sales growth and the margin improvement. Now let me move on, on how our organic investment program will support our future financial performance. Before focusing more closely on our new assets, let me take a moment to put our growth in context. The vast majority of our current revenue are generated by our solid base business. The base is a mix of more mature CDMO assets running at high utilization levels as well as our product business and new smaller-sized investments. This business is characterized by stable and high visibility revenue with above-average margins and cash generation. Alongside our base business, our growth is supported by our large organic investment projects. Currently, we have 21 large ongoing projects across our business. And now, let's take a look at these 21 projects. The 21 projects I just mentioned comprise our largest program with investments of CHF 50 million or more. Given that our increased investment phase started in 2021, most of the investments are still in construction, meaning they do not yet generate revenue. Looking across our growth project portfolio, the projects cover nine modalities, ranging from mammalian to highly potent API to fill and finish assets. The growth projects already in operations have delivered a cumulative CHF 1.8 billion in sales over the last 5 years. This does not include COVID mRNA revenues as pandemic-related assets were not expected to generate long-term sales. Most metrics on this page will look even stronger if these revenues were included. Most of growth capital is invested into commercial or mixed commercial and late-stage clinical assets based in Europe and in the U.S. This geographic focus is one of our point of differentiations from major CDMO peers. Finally, as you know, and as Albert mentioned earlier, we have strict financial thresholds when approving new projects. We acquire a project IRR of more than 15% and for the projects to generate a ROIC at peak of more than 30%. We also derisk our large commercial projects by signing anchor customers before commencing construction. Let's now take a look at the financial returns of the portfolio. On this page, we have ranked our 21 growth projects by their respective IRR. As you can see, the vast majority, over 80% of projects are expected to return 2x or more our cost of capital. Some projects are well advanced on delivering their returns while others are still ramping up or are under construction. Business cases are updated regularly and adjusted in line with market environment, construction time lines and construction costs. Our disciplined approach allows us to feel confident about our future growth and value creation potential. Now I know most of you are looking at the bottom bar, where projects returned less than 15%. So what are these projects? These are four projects, mainly in the clinical stage that are facing lower utilization than planned and taking longer to reach their full potential. However, as my division colleagues will explain to you later, the early stage and clinical assets deliver strategic value. They enable us to capture molecules early and feed our more profitable commercial assets. As we have received many questions on the timing of our growth projects, we wanted to share how we think about our portfolio composition across different investment waves and how this translates into revenue and EBITDA. While we show our 21 projects has waves on this page, to better illustrate the dynamics of investments, revenue and margin, we really pursue a continuous approach to capital investments. Wave 1 was dedicated to establishing our strong CDMO asset base across technologies. Today's revenue growth is driven by these projects and better asset utilization of our base business. We are currently reaching the end of the second wave, which saw the highest CapEx investment intensity. This is part of our strategy to invest proceeds from the sale of our former Specialty Ingredients business into more organic growth opportunities. These investments have focused on multiscale mammalian assets, additional ADC capacity and the founding of our commercial fill and finish offering. The second wave focused on growth opportunities in commercial assets for Biologics, Small Molecules and Cell & Gene. In the next 5 years, we will also need CapEx to replace some Ibex dedicated assets, like Moderna, and to rejuvenate some assets, ensuring they are ready to serve our customers in the coming decades. Over the next 5 years, we anticipate that CapEx as a percent of sales will reduce to mid- to high teens by 2028. The precise investment amount will depend on the market opportunities and our capability to deliver returns well above our cost of capital. Looking at the financial metrics. We are maintaining our return thresholds of 15% IRR and 30% ROIC at peak. The peak sales to CapEx rule of thumb for the portfolio is between 1x and 1.1x CapEx. This ratio, however, depends on the type of assets and the cost of construction in the different modalities. For instance, our fill and finish assets have different characteristics than our drug substance facilities. Having described to you each of our three investment waves, let me share some details on the contribution of our 21 projects to our financial profile and how this investment cycles translate into attractive revenue and margin over time. Please note that we are only showing growth CapEx here, and we have excluded the COVID mRNA growth investments, revenue and margin contribution. Again, this better shows the power of our growth projects without distortion from the temporary nature of pandemic-related business. The chart in the middle shows how our investments are turning into attractive revenue growth. The revenues are sequenced 3 to 5 years after the investment starts. This is the average time it takes to construct such large facilities. It means that today, we are enjoying the revenue growth from Wave 1 and we will see the overlay of Wave 2 revenues in the years to come. Finally, turning to the chart on the right, we can see the profit contribution of our growth assets. Similar to the revenue, profits are sequenced forward by an additional 1 to 3 years after finishing construction, showing the dilutive impact of the early years of production when assets are still in ramp-up. The last point worth mentioning, we are currently going through a phase with the highest number of project ramp-ups, as you can see in the middle graph. This is placing some short-term pressure on our gross margins. Let me now turn to some real examples of project financials, including the investment, revenue and profit profile of selected assets. Please bear in mind, however, that each project varies according to its underlying size, its modality, its location and its customer. Nevertheless, these examples are designed to give you a better understanding of the return profile within our portfolio. I'll let you take a look and take one more drink. Here, you can see the profile of a large-scale commercial biologic project. The project was derisked through an anchor customer and is expected to generate an IRR in the excess of 20%. It will deliver its peak ROIC in year 7 and remain stable thereafter. Capacity in this project is already fully committed with long-term contracts in place from a mix of large pharma and larger biotech customers. Here, you can see the investment cycle until year 4, followed by a dilutive period during the ramp-up as our OpEx spends begin. After reaching peak sales, the asset will move into a long, stable and high-margin phase. Now a slightly different example from a small-scale commercial biologics asset. You can see the shorter investment cycle for a smaller asset. There is also a faster ramp-up supported by a strong underlying commercial pipeline, hitting peak sales in year 5. This ramp-up is on the fast end of the spectrum for two reasons. First, the asset was more of an extension built into an existing shell with shortened construction time; and second, all customers for the asset were already Lonza customers. With this, I will end my section on our growth project portfolio and move to our capital allocation. In the coming years, Lonza will continue to invest in high-value programs as investments in percent of sales reduces and new assets produce earnings, we will increase our cash generation as shown on the chart on the right. Our divisional strategies and strong customer relationships will ensure our business remains a leader in the CDMO industry. My colleagues will explain in more details how our division strategies are maintaining our leading position in this high-growth industry. We are committed to margin progression through productivity, growth assets, margin progression and operational excellence. Our top line and margin growth, combined with improved net working capital will lead to 25% cash generation pre-growth CapEx. This cash generation, together with an already strong balance sheet, gives us flexibility in our capital allocation. Our capital allocation strategy, we continue to prioritize organic growth opportunities. You will hear some examples of this in the divisional sections. We will remain strategic and selective in funding growth projects, and we continue to expect returns well above our growth -- our cost of capital. We will continue our progressive dividend policy and have increased our committed payout ratio to between 35% and 45% to improve shareholder returns. Excess capital not allocated to organic growth opportunities and dividends will be considered for return to shareholders through other measures. Given our complete end-to-end value offering, we do not see significant need for larger external growth investments. However, we will continue to consider strategically relevant and bolt-on acquisitions if they are of high quality and offer clear benefits by providing either technological or commercial benefits. Now before moving to the divisional updates, let me take a moment to share a short update on our Q3 performance and our outlook on 2023 and 2024. Operationally, we are on track to deliver on our outlook communicated to you in July. Our business dynamics remain strong with high demand for our commercial capacities and multiple signings. My colleagues will touch on this in their section. Constraints in the biotech funding have continued but have not worsened. Latest data suggests a pickup in funding, but this is not yet visible in increased demand for early clinical services. Our Biologics early-stage business continues to grow versus prior year, but the division is not yet fully utilizing the existing clinical assets. For Cell & Gene Technologies, the market contractions continue to impact the clinical pipeline but the team is delivering successfully on its commercial projects. The Capsules & Health Ingredients divisions continue to see a softer nutraceutical market in the U.S. While orders have picked up slightly in Q3, the business has not yet returned to expected levels. Excess capacity in the industry for nutraceutical capsules is putting further margin pressure. Last, but not least, two recent customer events will impact the financial outlook for 2023 and 2024. First, the contract cancellation from Moderna we received in September; and second, the clinical trial failure for Kodiak Sciences, one of our bioconjugates customers. Let me explain the impact of these two events in more details. As you are aware, in September, Moderna announced its decision to terminate its mRNA production with Lonza as it rightsizes its manufacturing operations. Since the announcement of the cancellation of this multiyear contract, which was last amended in early 2023, our teams have been working with Moderna to agree on the termination conditions. While negotiations are still being finalized today, we are now in a position to provide an initial assessment of the financial impact. The contract cancellations leads to multiple accounting implications, including but not limited to the triggering of the termination fee, the impairment of certain equipment and the recognition of deferred revenue previously spread across the contract duration. In total, this leads to additional revenue of approximately CHF 0.2 billion with above-average margin in 2023. For 2024, there are no more revenues from Moderna, but some costs will continue for the suite, support services and people allocated to the asset. The exit fee is designed to give Lonza some protection by covering a portion of associated costs until the asset can be decommissioned and repurposed. As usual, with such terminations, this leads to an acceleration of revenue and margin into 2023 and a respective downside in 2024. Moving to Kodiak Sciences. The company announced the negative results of its Phase III result for its macular degeneration therapy candidate back in July. We currently expect lower demand than originally anticipated for 2024. But discussions with the customer are still ongoing. Both customers are using dedicated suites in our Ibex facility here in Visp. We cannot confirm what will happen with Kodiak at this stage, but the Moderna suites are being decommissioned and will be repurposed to capture new customers. Given the dedicated nature of the Ibex suites, we expect these to be repurposed in the next 2 to 3 years. Now what does this mean for 2023 and 2024 financial outlook? Let me explain the details, so we share -- we all share the same understanding. Let me walk through the following chart step by step. As mentioned, the Moderna contract cancellations leads to an acceleration of approximately CHF 0.2 billion of revenue with above-average margin into 2023. This will lead to both our sales and margin outlook for 2023 to be in the upper end of the range guided back in July. Important to note that including the Moderna termination agreement, we would expect to deliver results within the outlook range provided back in July. Now to 2024. 2024 will be a somewhat unusual year for Lonza. So I would like to share an early indication with you already today. We will, of course, provide proper guidance for 2024 when we talk again at our full year results presentation in January. The higher base in 2023 from the Moderna termination agreement and the lost revenue from Moderna created a significant year-on-year impact. Together with the risk of a smaller Kodiak Sciences business in 2024, this will offset all of our underlying business growth. We, therefore, expect 2024 to be roughly in line with 2023 in terms of revenues in constant currencies. An early view on our margins for 2024 points towards margin in the high 20s. This current early indication for 2024 no longer allow us to confirm our previous 2021 to 2024 midterm guidance. In terms of sales, the company will still grow at the lower end of the guided range when excluding the COVID revenues from all years. But the margin guidance cannot be confirmed at this stage. Now moving to the right. 2024 then becomes the base year for our midterm guidance where we are expecting to grow sales by 11% to 13% CAGR until 2028. The benefit of using 2024 as a base year is that it will show the true organic growth potential of the company without distortion from significant termination fees and COVID business. In summary, the Moderna termination accelerates revenue, profit and cash flow from 2024 into 2023, improving our outlook for 2023 but, at the same time, moderating our expectations for 2024. Before I close, I want to recap a few key elements I'd like to leave with you. We have reported a strong financial performance in recent years, and this year remains on track. Looking at our midterm we are set to deliver strong growth and profitability, driven by our broad and solid base business, complemented by our attractive portfolio of growth projects. We are excited about our midterm prospects and confident that we have the right strategy in place to deliver on them. Now with that, thank you very much for your attention. I'd like to hand over now to Maria, who will talk to us more about our growth projects.
Maria Nunez
executiveThank you, Philippe. It's a pleasure to be here with you today. My name is Maria Soler and I am the Head of Group Ops. I have working in the pharmaceutical industry for about 25 years in Lilly and Novartis in different global positions. I would like to share with you an overview of our governance model to deliver on our investment projects. I am going to concentrate here on the early stages of the project, what we have called in this illustration initiation. In the next slide, we will discuss the execution phases. We have a gated approach with prerequisites for each phase prior to moving to the next one. And the project doesn't move forward if we don't meet our criteria, especially at the beginning of the process. The process starts with a customer or a business request, and an alignment of expectations before we even decide to allocate resources to the project. That's what we call Gate -1. From there, we evaluate the strategic relevance and the commercial rationale of the project in Gate 0. Then we move to feasibility and further define the business case until we are ready to move to the CAR or capital authorization request. At each gate, the CapEx estimate the technical solution and the business case are further refined. We have very clear metrics for approval of the CAR, such as IRR and ROIC, which have been previously discussed by Philippe. Turning from strategic considerations to project delivery, I would like to share with you a few points on how we approach project execution and project monitoring. Execution involves the construction of the facility, the fit-out, equipment and facility qualification, process validation and approval by health authorities. Since the beginning of the project, we have a standard setup. We have an end-to-end leader supported by a multifunctional team that are there from the beginning of the project. The project is further supported by engineering standards, sustainability standards, project management standards, single-use standards, automation standards, et cetera. We also have a paperless system with templates for the tests that we need to perform. All of these elements provide consistency and speed throughout the whole process. On the monitoring side, we track individual projects closely as well as the full portfolio. We have standard steering committees. And we have full visibility and transparency on cost and schedule, amongst other metrics, allowing us to react to early warnings as needed. This close monitoring is overseen at structured timing by the Executive Committee and the Board of Directors. Our learnings are built into the program in a continuous basis. So now, let us share our growth in action and the scale of our CapEx projects here in Visp. The Ibex complex that is captured in this image was previously our plot of land. Construction progressed at pace and the first facilities, MC1 and MC5, MC means manufacturing complex, were ready for fit out in 2019. This year, we have seen further progress with the completion of the MC4 building, which is our joint venture with Chr. Hansen called Bacthera as well as the QC building. Looking across the site, a substantial proportion of this capacity is allocated to customers before it comes online, allowing us to manage risk. Now that you have seen the manufacturing complexes, let me place the CapEx projects in the context of the Ibex Biopark on the Visp site. As you can see from the illustration, we leverage the broader services in the Visp site from utility, security, firefighting to apprentices schemes, and we also utilized the additional infrastructure that is common to the Biopark, like the labs so that the manufacturing complexes can focus on manufacturing. The MC concept involves a pre-investment on the shell and therefore, a fast fit-out to suit customer needs. As an example, it took us approximately a year to do the fit-out of Moderna. It also enables a fast repurposing on the fit-up itself. So if I follow up on the Moderna example, we have already taken out equipment from the corresponding building, and we are already looking into repurposing this facility with new opportunities. So how does a project time line look like in one of these buildings? Let me share with you a simple outline of how we're delivering an example project. This is a mammalian drug substance manufacturing in MC2 with 6 x 20k bioreactors. The investment in the shell and common infrastructure comes first, accompanied by the down payments for the long lead time items, so these are equipment mainly, and initial design work for the fit-out. The true fit-out takes place in the following 2 years, with some payments coming up later. In this illustration, the color intensity of the arrows under the different years represents the level of spend. This patterns vary by project. In this example, the fit-out takes a full wing of MC2. And therefore, the shell and infrastructure represent from 5% to 10% of the total CapEx. The proportion is different depending on the size of the fit-out. Equally, the time line depends on the complexity of the project, the lead times for equipment, whether we are deploying a well-known technology or we are working on prototypes. The OpEx spend at the beginning of the project is minimum and will be driven later by the commercial facility, increasing until the facility reaches its full capacity. The revenues may commence with some precommercial activities, followed by commercial batches until reaching peak revenues, in this case, 2028. In this case, there was a certain overlap between the shell and the fit out as we needed to invest in this asset very quickly to satisfy the needs of an anchor customer. However, if we already have the available space in an existing building, the only time and investment that we need is that of the fit out. One of the key advantages of this manufacturing complexes is the flexibility to accommodate different scales, technologies which can be tailored to customer needs. I would like to show you quickly a few examples of the modalities that we host in these MCs. Mammalian, where we have our large-scale joint venture with Sanofi; Microbial, where we have a mid-scale facility and antibody drug conjugates, when we offer an end-to-end capability. On the next slide, you see some further examples. First, mRNA, where we delivered the COVID-19 vaccine. In the middle, you see the drug profiling service which adds new offerings to our Lonza portfolio. And then on the right, we have the Bacthera joint venture facility that I mentioned before, which is dedicated to microbiome. So to summarize. From concept to launch, we have a rigorous gating process in place to deliver all our growth projects. This approach allows us to be confident in our capability to create long-term value for the business. We accomplish this through the strategic selection of programs to meet our customer needs and are in line with our return criteria. From design to execution, the standardized approach is meant to give us efficiency at every stage of the process. The whole process is closely monitored to ensure we remain on track and on budget. We react quickly to issues and carry the learnings forward. You will have an opportunity to see some of these investments today in the touring Visp. With that, I would like to thank you for your attention, and I hand over to JC to talk about Biologics strategy. Thank you.
Jean-Christophe Hyvert
executiveMany thanks for the introduction, Maria. It's a pleasure to be with you today. My name is Jean-Christophe or JC for short. I've been working at Lonza now for 7 years, first as CFO, then as CCO for the pharma and the tech business. For the last 3 years, I'm the President of the Biologics division. The bio division -- the Biologics division represents around 50% of the Lonza Group business. This overview shows that we are operating in a very attractive market with healthy and sustained level of growth, around 10%. We are very well positioned with close and long-standing customer relationship based on the broad portfolio of offerings. We bring together a combination of five fundamentals: Expertise, agility, speed, integration and shared risk. Each of these are designed to address the needs of our customers and the market dynamics. Within our division, we house 5 or 6 business units. Today, I would like to share some details about our mammalian, bioconjugation, microbial and drug product services offering. As a division, our ambition is to strengthen our position as a CDMO partner of choice. And I am pleased to say that our market research confirms that our ambition is reality. The Biologics strategy is based on three pillars. These pillars have been developed to meet the needs of our market and of our customers. By focusing on full life cycle management, we acquire the customer and the molecule early. We then retain them through the path to commercialization. 75% of our customers come for us for further work. Now turning to our end-to-end offering. An increasing portion of our business is integrated across modalities. Customer values the expertise, speed and ease of doing business with a single strategic partner. 7 out of our top 10 customers need cross modalities solution. It is also a key for biotech companies that don't have the expertise or resources to cover these needs internally. And finally, our global network allows us to stay close to our customers while supporting supply chain resilience. By following these key priorities, we are able to deliver above-market growth and superior EBITDA. Now I'm pleased to say that the strategy is working. In Q3, we signed a number of very significant long-term contracts leading to multibillion commitment. Here, you can see an overview of recent large contract wins. First, we have secured an Ibex-dedicated program with a customer with whom we partnered early in the clinical stage. They now take a path to commercialization. This is life cycle management. It also requires work across multiple modalities. Second, we have entered into a large conjugation deal for the full life product cycle. And third, we have secured our first commercial fill and finish ADC program. It delivers the end-to-end offering I was referring to. We have also negotiated the expansion of a large pharma relationship. As I mentioned before, 7 out of our top 10 customers are now active across multiple modalities. We are pleased with the performance. We are working to build on this momentum to secure our pipeline and further expand our customer base. Now looking at the wider CDMO market. We can see a strong opportunity. The fundamentals are strong. The market is expected to continue to grow at 9% to 11% CAGR as shown on the right graph. We anticipate that demand will continue to match or outpace capacity. CDMO capacity continues to outpace in-house capacity as large players rely increasingly on manufacturing partners to support their journey to market. The next slide will show the trends and our unique position to capture the dynamics. As I mentioned, we are seeing that the industry is turning more and more towards CDMO, in particular, partnering relationships. The model is attractive to our customers as it enables capital preservation, direct access to leading expertise, derisk supply and regulatory support. We serve the entire spectrum of customers from biotech to large pharma. Large pharma accounts for the majority of the share of the value of the market, in particular, of the commercial market. At the same time, the largest share of the molecule market is helped by smaller biotech. The smaller players build outsourcing into their business model to conserve capital resources. They look for partners to support them through the journey to commercialization. While funding has affected the segment in the short term, we expect recovery. And we already see some positive signs in September. To meet the needs of our customers, we have complemented our commercial scale capacity with clinical and launch capacity. We can serve any scale across our global network and support customers through the life cycle of the molecule. These complete and flexible offering means that we benefit from a high level of repeat business. I noted before that 75% of the customer we acquire come for additional purchases at Lonza, once they enter into a relationship. Now looking at the number of molecules. In the Biologics pipeline, we see strong and continued growth across all phases. This growth is matched by the diversity of modalities, and that's what you see on the right-hand side. We are very well positioned to capture both the market growth and the diversity of the market. We can deliver tailored services that are flexible to scale and to complexity. This is the advantage that comes with our broad offering. Importantly we also bring the advantage of deep and long-standing industrial expertise in delivering commercial scale. The table presents our offering across four key modalities. We can deliver drug substance from late discovery all the way to commercialization. We have invested to enhance our capabilities and scope in the last 3 years. This is in line with our three-pillar strategy. Our most established capabilities lie in mammalian, where we are the market leader. We have completed our bioconjugation offering, a very high-growth modality, and I will talk more about it later. We also developed offering in microbial and in mRNA platform where we see significant advances. These drug substance offerings are now supported by our drug product services, a key area of focus. We have developed the full end-to-end offering. Finally, our regulatory expertise provides our customers with strategic support as they navigate the path to market. Our offering support our strategy and our strategy is working. It's important to note that most of our sales and profit come from the commercial segment. On the chart, you can see how the strategy does work. The left chart shows that the major proportion of our revenues are driven by commercial sales. The right chart shows that our customer relationships formed in clinical phases are feeding our commercial pipeline. In fact, around 50% of our commercial sales today are captured in clinical Phase II or before, and the proportion is increasing. Our understanding of our customers, our end-to-end offer and our life cycle management are the key to our sustained success. It drives customer satisfaction and improve our investment visibility. We are a pure play CDMO. We exclusively focus on the needs of our customers. In addition, our integrated offer across the life cycle is securing a market advantage. Our offering is the most complete in the industry. This is supported by advanced and diverse manufacturing technologies, which ensure that we can manage a molecule at every stage of its journey. Thanks to our global network, we can tailor the offering to support the customer, whether their focus is driven by the need for speed or scale, the challenge of complex manufacturing or the desire for regulatory expertise. We have the tools and talent to pave the full path from clinical phase to commercialization. And finally, our reputation for quality, reliability and expertise strengthen the appeal of our offering. Having shared an overview of the full division, I would like to share some more details on some key business units, and we will start with Mammalian. Mammalian is a recognized industry leader and a significant contributor to divisional success. Our reputation is based on our capabilities and consistent delivery over the years. Our strategy strengthens our positioning. Between 2020 and 2023, we anticipate 15% CAGR. It is supported by the additional capacity coming from CapEx investment in recent years. This above-market growth is supported by a strong pipeline, a healthy win rate across both clinical and commercial phases. Turning to supply and demand. The chart on the left is a supply and demand graph. The X axis is expected demand and Y axis is expected supply. The dot shows where the balance stands in a given year until 2028. We expect capacity utilization to continue to increase as demand will continue to outpace supply, especially at large scale. We are already seeing strong market potential for high-volume demand. This includes, but is not limited to, Alzheimer. We are well positioned to serve these market needs with a network that is set up to deliver large-scale and complex programs with multiple supply points for direct supply. Our Mammalian business units benefit from strong industry fundamentals, including a healthy pipeline of molecule across phases. This will continue to grow as pharma companies continue to invest in R&D and invest in the molecule pipeline. I have already touched on the capacity expansion across the CDMO industry. In Mammalian, increased demand for large-scale manufacturing will absorb the new capacity coming online. In fact, we anticipate that Mammalian capacity will remain tight as we look ahead to 2028. In this high demand market, we command a leading position, broad range of offering, innovative technologies and deep level of expertise. One area of focus within Mammalian was and is the development of our pipeline. It feeds the commercial demand. We have a strong reputation for commercial capabilities. We have also built an engine for molecule acquisition through our early-stage services. We have built retention through additional small scale capacity. We do this effectively and efficiently. For instance, to enhance our early-stage offering, earlier this year, we expanded our early development services in North America. We now have a facility in Cambridge close to the Boston biotech community. It supports customers through the early stage of drug development. On the right, you can see the impact of the strategy. Our molecule pipeline across phases has grown above market in the last 3 years. Here, you can see a snapshot of our offering. We have built the leading offering. While some competitors are able to meet many customer needs, there is no other player that has a complete set of services, depth of expertise across scale and capabilities that we do offer. We have a unique asset portfolio from small scale disposable bioreactors for smaller volume to large scale stainless steel bioreactors for larger volume. We can offer tailored and cost-effective solutions at each stage of the product life cycle. It has allowed us to build deep customer relationships, which leaves us well placed to capture future market growth and demand. Now let's take a look at our bioconjugate offering. I think bioconjugation is a great example of another modality that -- where we have anticipated the market need. We entered the modality as an early mover and developed expert capabilities and innovative offering. It has allowed us to capture customers and build a reputation ahead of the competition. It is the same strategy that we pursued for our Mammalian business. Currently, we are seeing about 10% growth in bioconjugates, and it rises to 30% for antibody drug conjugates. Our ability to integrate across modality is unique, and bioconjugation is a key driver of growth for Lonza. We have significant and further growth potential. Before we take a look at the market, let me take a moment to share the science of antibody drug conjugate or ADCs. At Lonza, ADCs are delivered by a tight collaboration across the organization. On the chart, we have labeled the contribution of the bio division in blue and the contribution from the small molecule division in green. The antibody to target cancer cells is developed in Biologics. The cytotoxic drug that destroy the cancer cell is made in our Small Molecules division. The linker that binds the antibody to the cytotoxin is also made in the Small Molecules division. These components are brought together through bioconjugation process and then made into drug product in the Biologics division. The process is just as complex as it sounds. It requires a high level of technical expertise and leading technology. Because we have integrated capabilities under one roof here in Visp, Lonza is a preferred partner for commercial ADCs. For those of you in the room today, we will have a chance to visit our bioconjugation suites in the afternoon. Now turning back to the market. Let's take a look at the future growth potential for bioconjugation. The market for ADC is expected to grow at around 30% over the next 5 years. As the supply chain and manufacturing for ADC is highly complex, there is a lack of available capacity today. Our customers are looking for a CDMO that can bring together the different parts of the manufacturing process under one roof to help manage complexity and manage risk. On the right chart, you see a strong pipeline of ADC molecules in development. We are already increasing the number of early-stage molecules that we can support and will continue to do so. This is part of our strategy to bring molecules early in their life cycle. Here, you can see our offering compared to our competitive set. We have assembled the most complete solution from drug substance to drug product now to ensure we meet customers' need. We moved in early and today, we are the market leader in bioconjugation. We are working and investing to maintain this momentum and build on our reputation. Our ADC is a very strong example of the bio division strategy. As you can see on the left slide, 75% of our bioconjugation programs are integrated with another modality and services. It drives customer retention and it creates value. More generally, we see a pattern for increased integration across modalities. 7 of our top 10 customers work with us on multiple platforms. We have also observed an increased demand for integrated services. In line with our strategy to differentiate, we're investing in R&D and innovation. We want to ensure we meet market demand and market supply for more diverse and complex ADCs. On the right, you can see that our business is growing at a fast rate. Today, we are delivering more than 4x the number of batches than we used to, and batches are produced at a higher volume. We have responded to market needs and customer needs with new multipurpose assets, dedicated assets, the acquisition of Synaffix and additional commercialization expertise. There is a real opportunity, both for the ADC market and for Lonza. Now let's take a look at our microbial business. Our strong and sustained performance in the microbial space really shows how we drive long-term value through differentiated offer and how we adapt over time. The microbial modality is highly diverse and showed solid level of growth. Between 2019 and 2022, our molecule pipeline has grown by more than 15%. Traditionally, used for producing hormone enzyme and certain vaccines, microbial fermentation is becoming an increasingly attractive route to support new and complex molecular formats. With more than 30 years of experience in microbial fermentation, Lonza has a well-established track record. Our service and long-term reputation hold a significant value for our customers. Our microbial sales have grown by more than 35% in 3 years. We are building on this momentum by continuing to grow our capabilities and capacity. This includes a ramp-up of our mid-scale commercial manufacturing asset here in Visp. The pipeline growth in microbial underscore our confidence in this market. On the left, you can see the number of molecules in the pipeline is sectorized by 4% CAGR between 2023 and 2028. While the market growth is solid, growth in capacity is expected to be more moderate. As you can see on the right side, we are well placed to capture demand with a selective molecule acquisition strategy. In addition, our expression systems also support our development and manufacturing offering. Turning to our competitive landscape. Our offering is now complete. We continue to execute our differentiation and differentiated strategy. We are well placed to support microbial customers from clinical stage to commercial manufacturing. Now to complete the tour of our modalities, I will share a few details around our Drug Product Services business units. We established DPS 7 years ago with formulation services and a handful of colleagues in Basel as we identified a big market opportunity for Lonza. Our goal was to gradually complement our drug substance offering with drug product services and manufacturing. Since that time, we have gradually built a leading offering to help customers address a range of challenges across formulation, analytical and process development and drug product manufacturing. We have built deep expertise, for instance, in formulation, and we have expanded from clinical and now into commercial fill and finish. Our drug product offering is expected to deliver top line sales of around CHF 140 million this year despite being highly exposed to the clinical market. It represented 20% year-on-year growth since 2020. As a reference, in 2022, we executed 180 customer programs, and we expect to match that number in 2023. We also signed -- or we also recently signed an anchor customer for commercial drug product -- for our commercial drug product facility here in Visp and we have multiple BLAs underscoring our path to commercialization. Our drug product business support our complete end-to-end CDMO offering. It's attractive to our customers as it simplifies supply chain. Our customers increasingly want a single strategic partner that can deliver end-to-end across drug substance and drug product. Our drug product business operates in a highly attractive market, driven by, as we discussed, the large and growing biologics pipeline and an increased focus on injectable dosage forms. The market for Drug Product Services is expected to grow 7% CAGR, in line with the wider Biologics market. On the right, you can see that the market for sterile injectable is highly outsourced. As an example, 70% of commercial manufacturing is delivered by external partners. With our new commercial capacity and integrated offering, we are well positioned to capture these positive market dynamics. Before closing, I will briefly touch on our competitive landscape. We have closed the gap to competition in Drug Product Services. Today, drug product is a truly complementary offer to drug substance. As I mentioned, around half of our current portfolio of product opportunities are linked to our supply of monoclonal antibodies. 40% of customers' inquiries today are for integrated offering. As of 2026, we will be able to compete with all large fill and finish operators. Our strategy differentiates us, and I believe it's winning. As we finished our tour of the main Biologics modalities, let's take a divisional look at our operations, innovation and financials. Here, you can see our Biologics network. We have an established and balanced network across modalities, scale and geographies. Our global network allows us to stay close to our customer while giving them the advantage of a derisked supply chain, which is a very important topic today. Our center of excellence in key sites offer deep specialized capability and world leading expertise across all of the modalities. There is no other operator today that can offer customers such a broad, deep and expert set of capabilities across the globe. Turning to innovation. Innovation is a key pillar for the Biologics strategy, and I want to touch on four key areas. It helps us maintain our market advantage. First, we can now support customers in moving from gene to IND in 11 months or less for standard monoclonal antibodies and 13 months for more complex proteins. The speed and efficiency is attractive to customers. Second, we continue to focus on continuous bioprocessing and process intensification. The goal is to improve productivity and reduce cost of goods sold. Third, we continue to invest in early-stage capacities and -- sorry, early-stage capabilities. Just last month, we opened a new mRNA process development and small-scale manufacturing facility in the Netherlands. And finally, we're integrating digital platforms into the drug development and the manufacturing journey to improve speed, flexibility, efficiency while managing the cost base. Alongside our innovation strategy, we have built a licensing business unit. The business unit makes our IP, intellectual property available to companies that develop new drugs. Our historical strength in GS expression systems has now been complemented by technologies such as bispecific platform and other expression system including viral vector. As the offering is mostly targeted at early-stage companies and drug development, it helps us take current on the latest market trend by having that specific insight of early-stage companies. The highly profitable business unit, though, is growing slower than the overall division. From 2019 to 2022, the bio division has grown at 20% CAGR. Our growth was driven by both new projects coming online as well as base business expansion. It includes Moderna, and Philippe has discussed and given you the impact of the Moderna business on the company on bio. Our CapEx supports the strategy. Our investments have supported the clinical pipeline, and we have built a world-class infrastructure at key sites like Visp. The launch and ramp-up of current CapEx projects will drive future growth, and it helps us capture an increasing share of the commercial space, which we derisked through the pipeline building I was discussing before. The investment strategy will generate strong and lasting value for both our customers and for Lonza. Now turning to our finances. As discussed by Philippe, our midterm guidance anticipates mid-teen CAGR from 2024 to 2028 and EBITDA margin of above 35%. In 2024, we expect continued demand for CDMO services. We see margin pressure from the ramp-up of new growth projects and lower clinical demand. At the same time, this will be balanced by our stable base business. In the midterm, we expect sales growth to outpace market growth driven by large commercial contracts and the completion of our CapEx projects, for instance, in Visp, Stein and Portsmouth among other locations. Margin will normalize as our growth projects come online and mature. To summarize and close, we are the market leader in biologics, offering a pure-play exposure to early and late-stage molecules across modalities and we have a very diverse customer base. Our position is supported by a sound strategy to capture current and future demand in a very attractive market. With that, I want to thank you for your time and attention. And next is a break before Gordon covers the Small Molecules division. Thank you very much. [Break]
Gordon Bates
executiveHi. Good morning, everybody. My name is Gordon Bates. I've been at Lonza for 20 years and have held various operational and commercial roles across three of our divisions. I'm responsible for the Small Molecules division and have been responsible for Small Molecules since 2015, and I joined the executive committee in 2021. What I'd like to share with you today is a brief overview of how our strategy is delivering sustained sales and profit growth. Our capabilities are responding to market trends with reputation that's been built over 40 years, and then some insight into the small molecule market and particularly the areas where we want to target. So firstly, on our strategy. The first real point to get across is that our focus is on innovative molecules. We believe that with our capabilities and the trends we see in the market, the best chance to create and capture value in small molecules is to play in this innovative space. So our strategy is focused around three pillars. So the first one is to be a strong development partner driven by science. It's important for us to have a continued flow of clinical programs coming through and our capability to consult at the early stage with our partners to be able to help them resolve problem statements and allow their molecules to progress clinically. Secondly, we don't just want to be a development house. Our goal is to participate in commercialization of projects. So we are responsible for providing a pathway and showing our customers how we can commercialize their molecule. And thirdly, of course, we want to make the customer experience great. I think we all have that experience that something that we experience that's good, then we want more of it. And it's no different for us. And we invest a lot of time in our people because it's our people that make the difference to the customer experience. Whether that's investing technical career paths or leadership career paths, there's a focus to keep and develop people in the organization. And we also invest in some simple trainings, whether it's about customer intimacy or whether it's about customer empathy. So perhaps moving on to tell you a little bit more about Small Molecules. There are two major parts to our Small Molecules division. There's drug substance and particle engineering and drug product. So drug substance is the active ingredient. Particle engineering, micronizational spray drying technologies to improve bioavailability or drug product, which for us is oral, either formulation of a capsule or in a tablet. Rough order of magnitude, ourselves, 80% drug substance, 20% in particle engineering and drug product. Our overall sales, 80% of our sales are for commercial products. And we have in excess of 100 commercial products and probably in excess of 200 clinical programs. Now we've been doing this for nearly 40 years. So we're quite good at it. The feedback that we get from customers is that they really value the capability that we bring for quality, security of supply and solving scientific problems. We have tenured customers, more than 20 years. So they've been with us for a very long time. And also those relationships that are developed allow further programs to be awarded to Lonza. JC talked about integrated program in his presentation in bio. And here, what we see as well with customers is the integrated capability in Small Molecules can be drug substance to drug product, but also across division, then we can have the capability integrated between Small Molecules and bio. So moving on to the market. It's pretty healthy pipeline for Small Molecules in the market. And here, you can see that more than 50% of all molecules in development are small molecules, it's approximately 10,000. And we expect to see that grow by 30% over the next years. Now one thing that's really interesting for us as a company is that while we have small molecule capability and also bio, large customers with deep pipelines that are agnostic of technology to be able to work with one partner that's capable of providing, whether it's a small molecule or a large molecule, is something that brings great value. The market size in small molecules, you can see is around about CHF 70 billion and is expected to grow over the coming years. However, if you go back to what I said around our strategy that we're focused on innovative molecules is a large part of this market that we don't play in. We play in the area where we think we can create and capture value. And our estimate of the size of that market is about CHF 25 billion. So on the CHF 70 billion market, we believe we're one of the leaders. We believe we're one of the leaders, yet we have a market share of perhaps 1% to 2%. That tells you how fragmented the small molecule market is that Lonza, as a leader, has a small market share. Of course, there's a huge proportion of generic products in there. Now looking at our capabilities and how those capabilities respond to some of the trends that we see in the industry. So I talked about the growth in small molecules that's coming and there are three therapeutic areas where we see the strongest growth. So oncology will grow at double digit. CNS and endocrine and particularly diabetes, will grow at high single digit. Oncology products, the needed toxicity of them to kill cancer cells means that more often than not, they're highly potent. And highly potent need specialist manufacturing with high containment. We have a very long track record of developing and manufacturing highly potent products. We also see that there are more drugs with solubility challenges. Solubility is important for drug effectiveness, the ability to be able to absorb into the bloodstream with poor solubility is compromised, and it leads to low bioavailability. We have a facility in the U.S., Bend in Oregon that are recognized industry leaders at resolving bioavailability challenges. When we look at the number of molecules that are in development, we know that most of those owned by smaller companies. And those smaller companies, as JC mentioned, they don't have assets. They need consulting support and expertise to help them resolve their problem statements, to help them move programs through their clinical pipeline. And the consulting approach that we can bring with the 40 years experience that we have, highly tenured people with deep expertise can help those companies move their molecules forward much quicker. We also have the regulatory capability to write their filing documents for them and help them to do that because we've done it so often. And that is a great value to smaller customers who haven't quite had the experience of being able to file that. The regulatory environment, we see more and more drugs on some degree of fast track or accelerated approvals. And here, we are well placed not just with the regulatory support to help, but also our processes are very mature to be able to move quickly and our ability to be able to scale and commercialize quickly can make a significant difference to the speed at which customers bring their product to market. To put that in context, here, you see the chart that shows more than 50% of our current sales. We started work on the molecule Phase II or earlier. So we participated, aligned with our strategy to be present throughout the product life cycle by doing development work as early as possible that then supports the commercialization of the product. And of course, products can drop in all along the continuum. So if they're not dropping in Phase II and earlier, someone may be bringing a commercial product or second source or a late phase product ready for commercialization. Now here, you see in our clinical proportion of our portfolio, and I mentioned 80% of our sales is commercial, it's important that we continue to invest in our clinical assets to be able to bring more products through the pipeline. And we have a pretty healthy pipeline. So I talked about oncology being double-digit growth. CNS, endocrine, particularly diabetes, being high single-digit growth. In our portfolio, we're extremely well represented across those growth therapeutic areas. My estimate in the next 5 years is that we'll have an additional 35 products commercialized from our late-stage clinical portfolio that we're already working on. So as part of that experience of showing how we can scale up and do that rapidly, a couple of examples to share with you. Firstly, you can see our sales growth over the last years has a stronger component of growth in highly potent products where that the containment specialist manufacturing expertise and process control are critical to success, and it's around about 30% of our sales at the moment. Two examples to share. So we built a new factory in Visp. So here, you'll probably see that today on your tour, where we did the late-stage development work for some products that scaled and have been manufactured in this asset over the last few years. Equally, we're building a new manufacturing complex, where there's a product in there that is crossing the two divisions between bio and Small Molecules with an integrated offer. And both of these have long-term take-pay contracts. And this new manufacturing complex has further space for expansion, our mini Ibex, if you like. So moving on to the financials. You can see strong growth over the years. But here, I'd like to point out to you, you see the up and down of growth, so high one year, lower the next. That sort of affect on our growth. Our production process has run from anywhere between 10 months and 2 years. And unfortunately, production processes are not great respecters of financial reporting periods. So you're going to see this growth, and please look at our performance over the long term. In terms of profitability, we've done a lot of work to adapt our product mix. So we're moving very much into those areas where we believe we can create and capture higher value. We've divested some assets that were noncore, and we continue to drive our operational excellence programs. And with the factories getting busier, the operating leverage that comes is reflected in the profitability that you've seen over the last years. In terms of future expansion areas, I mentioned that we've got quite a healthy pipeline of products that will commercialize over the next years as well as existing demand. And here, our investment priorities will be adding more drug substance capacity, reinforcing our early phase capacity to make sure that our lead times remain competitive and then with our particle engineering late-stage pipeline, expanding capacity to be able to capture the value there in the future. So our CapEx, I would expect 70% to 80% of our CapEx to be invested in growth assets. So from a future trajectory, our guidance is mid- to high single digit with margins greater than 30%. We have a very strong coverage on our base assets. We have a record order book, and we have good contract coverage across the different assets that we have. I mentioned a healthy pipeline that are coming through to commercialization, and we continue to drive our operational improvements. So perhaps pulling all of that together in a summary, I mentioned that we've been doing this for a long time. We're quite good at it. We have a good reputation in the market and the areas that we play in are attractive and profitable. So maybe as a final word, and I hope you can agree with me if I paraphrase and steal from Mark Twain that rumors of the death of small molecules are greatly exaggerated. So thank you for your time, and now I'll hand over to Daniel. Thanks.
Daniel Palmacci
executiveGood morning. It's a pleasure to be here today to share some of the Cell & Gene strategy and our outlook. So my name is Daniel Palmacci, and I head up the Cell & Gene division. I've been in the business for 25 years in biopharma organizations. And I had a great opportunity to work for companies like Novartis, Bayer and, of course, now Lonza. So let's start with a short summary of our current business. I would say it's fair to say this is an exciting time as we see that Cell & Gene is really working. Many of these transformative and sometimes even curative therapies are now moving towards commercialization. And we believe as a fact, we, at Lonza, are actually very well positioned to capture those market opportunities through our strategic pillars. First of all, manufacturing matters and in Cell & Gene even more than in other modalities. And we have a track record of efficient manufacturing. Second, we have shown our strong capability to support our customers to bringing their products to the market. And thirdly, we continue to focus on key partnerships that will provide some strong examples of these. Our division has three key business units. We have our CDMO business, we have the Bioscience, BU, and we have the Cocoon platform integrated in the Cell & Gene division. We can integrate these products out of those business units into our CDMO services, and that creates very strong manufacturing platforms. And this is exactly what our customers need in Cell & Gene. So let's start by looking at the different key business units. First of all, the Cell & Gene Technologies, which is our CDMO business. Let's have a look at what we have built so far. Over the last 20 years, we have established a leading position based on our process development and the GMP manufacturing experience. The business unit has grown mostly organically and leveraged Lonza's strong manufacturing reputation for delivering those highly complex molecules. And as a result, Cell & Gene Technologies has delivered a 30% CAGR between 2018 and 2022 and turned into a positive EBITDA margin. To date, we have a large proportion of outsourced Cell & Gene products in the CDMO industry. Let's have a look at the markets. So we saw that in the beginning, we saw a high level of investment in the early days, and that was later followed by a pruning period where funding slowed down. We all know that. For Cell & Gene, this is a classic trend as in many areas where new technology takes off, is then slowed down and then follows by a more stable growth. And that slowdown in Cell & Gene in the last 2 years has been mostly in preclinical and early clinical phases. The products of that initial funding cycle are now reaching commercialization. And this is exactly where we focus our business on. So obviously, we see that commercial therapies generate higher value compared to clinical programs for CDMO companies. And on top of that, we see that an increasing trend towards outsourcing. In the next slide, I will show that trend. And those are the key drivers for the outsourcing. And this trend, of course, further supports our position in the market. As we look at our strategy, we see that we are positioned to continue capturing market value by addressing key customer needs. CMC/BLA derisking, we're experts in. So chemistry manufacturing controls and BLA, which is needed for the application, derisking that process is critical to support the customers all the way from preclinical to commercialization. We did that with Bluebird Bio, for example, with where we brought them and accompanied them from the very early preclinical all the way to commercial products. Looking at our capacity, I think it's pretty clear, as we learned from my colleagues, this is in the DNA at Lonza, right? We have really the ability to be pretty flexible with our capacity to build as needed. Turning to new modalities. We see exosomes and pluripotent stem cells, just to give some examples, bringing high future potential, and that will help continue to feed our pipeline. And for obvious reasons, we continue to invest in those new modalities to be leaders today and remain leaders tomorrow. We, of course, understand that cost is a key challenge for our customers. And as a premium provider, we focus on cost reduction through operational excellence, simplification, innovation and automation. Let's have a look at our competitive position. We have a strong position in key modalities and across our service offering from process development to commercial manufacturing. Take this all together, our offering is amongst the most complete in the industry. Let me walk you through the balance between capacity and capability in the cell and gene market. Cell & Gene processes are smaller scale and still highly manual. This means our costs are more focused on people, so meaning highly skilled operators and scientists. And we, of course, continue to develop and attract those capabilities. You can see on the left -- around 70% of the manufacturing costs are related to employee costs. So it's not capacity but really capability that defines the success. And we hold the largest cell and gene CDMO capability in a highly fragmented industry. Of the 22 cell and gene products approved since 2015, 11 have been outsourced. And we support three of them. So these three are delivered by our site in Houston, which is the only CDMO site with three commercial cell and gene products in its portfolio. And in total, we have currently six sites, and some of those will also become commercial cell and gene sites in the next 18 months. As a matter of fact, we expect to add four more commercial products coming from our existing pipeline in the next 18 months. And as a result, we will also have three commercially approved licensed sites in our network. With more commercial products coming into our pipeline, our revenue share from commercial projects will increase from 25% today to a total of 70% by 2018 -- 2028. And here's where our strategy makes sense. The shift to commercial provides the opportunity for long-term contracts and stable revenues. And on top of that, commercial products also deliver higher margins. Our long-term success also depends on our investment in novel technologies. And I would like to share two examples where we really capture some of those emerging opportunities. First, we have entered into a strategic partnership with Vertex. And we're building a new dedicated facility in New Hampshire, which will manufacture Vertex stem cell technology for Type 1 diabetes. Yes, that's right, Type 1 diabetes. And this therapy has the potential to be the first curative for Type 1 diabetes. Isn't that amazing? I mean I'm so excited about that. So second, we acquired the core assets of Codiak BioSciences which specialized in exosomes. And acquisition included the manufacturing of the facility in Lexington, Massachusetts, and we also acquired the manufacturing IP. So let's have a look at our second business unit, which is the Bioscience business. Our Bioscience business has a strong portfolio of products that support the growth of the biologic cell and gene market, biologics and cell and gene. So let me touch on the key offerings. Cell culture media is very critical raw material for cell and gene and the biologics manufacturing. Nucleofector enables to be genetically modified using electric fields. So it's a great cost-effective alternative to the viral vectors as we see it today. Thirdly, endotoxin testing is required for every product that is being delivered intravenously to a patient. Finally, the MODA platform is our manufacturing software for batch recording and monitoring. And we have seen a high and sustained demand for these products. This has allowed the Bioscience business to deliver 12% revenue CAGR over the last 5 years. And in the same time frame, the profitability grew from single digit to more than 30% EBITDA margin. In this business, of course, innovation drives advantages to meet customer needs and let me just touch on a few of them. So customer needs consistency, meaning less variability from batch to batch. They need ease of use, high performance and cost efficiency. And our two new media, TheraPEAK and TheraPRO CHO, are both chemically defined and of nonanimal origin. They have been launched earlier this year. They provide less variability, and they're also simple to use as they require less component to be at -- to the process. Both media enable low COGS with the best productivity in the market. And finally, on the right, we launched a new microplate reader to our endotoxin and pyrogen testing portfolio. And this simplifies and supports QC labs with significant improvements in accuracy and consistency. With that, I would like to move to our third business unit, which is the Cocoon, we call it the personalized medicine business unit. So as a reminder, the cell therapy production process is highly complex, and it relies heavily on manual support. On top, there's logistics complexity for these therapies. As a matter of fact, it can take 4 to 6 weeks between collecting the cells and infusing the treatment back to the patient who is waiting. And Cocoon can address many of these challenges. First of all, it provides the option of point-of-care treatment, which can mitigate delays, shipping complexity and related costs. The Cocoon is highly automated, which also reduces costs and obviously, the risk of human error. And finally, the technology is scalable as you can combine multiple instruments to be connected in a, as we call it, a cocoon tree, which can save significant clean room space. So let's have a look where we got so far. So far, we have installed more than 100 instruments. We currently have around 20 customers, including one large-scale point-of-care manufacturing partnership with an anchor customer, Galapagos. And as we have pointed out, these treatments can take 4 to 6 weeks, vein to vein, meaning patients sometimes even pass away while they're waiting to be treated. And the point of care reduces this logistics complexity. With our partner, Galapagos, we have been able to consistently deliver treatments vein-to-vein in only 7 days. In total, there are now six active clinical trials treating patients use the Cocoon, and all of them are consistently meeting product quality requirements. The Cell & Gene division delivered solid growth of 18% CAGR between 2019 and 2022. At the same time, the core EBITDA increased from minus 7% to plus 17%. We achieved this with the complementary portfolio of products and services that enabled organic customer acquisition and a clear focus on commercialization. Our division has continued to form pioneering partnerships that will set us up for long-term success. And we have seen some short-term industry challenges, but cell and gene therapies are advancing into the commercial phase. And we see that our strategy has delivered successful results. Looking at our midterm guidance to 2028. We have committed to top line growth at mid-teens figure with a core EBITDA margin of more than 25%. We will deliver this by increasing our share of commercial projects. And we also increased our margin through operational excellence and higher asset utilization. Finally, we will continue to invest in technologies and integrated offerings to support our long-term success. In summary, I will leave you with these three key points. Firstly, our division has three complementary businesses that deliver value for cell and gene therapy developers. Second, we're focused on becoming the leading commercialization engine for these complex and novel therapies. And finally, we'll also invest in new technologies and platforms and continue to grow our product business. I will close by reiterating our commitments to mid-teens revenue growth and consistent margin improvement for the midterm, core EBITDA margin of over 25% by 2028. With that, I thank you for your time, and I will hand over to my dear colleague, Christian. Thank you.
Christian Seufert
executiveThank you, Daniel, and hello to you all. I'm really excited to be here and introduce and talk about the Capsules & Health Ingredients division and its strategy. I joined the Lonza Executive Committee mid of last year. And after 20 years with BASF in multiple global roles, amongst other, the Head of the pharma solutions business, I'm really excited to be part of this strong team. Our Capsules & Health Ingredients division has built a strong customer reputation to capture advantage in all our target markets, particularly in hard empty capsules and dosage form solutions. Our 7,000 loyal customers tell us they appreciate our broad product portfolio and service offering as well as market-leading quality standards. Our customers tell us that they value our key strength of customer centricity as well as our strong commitment to science-backed innovation. We will continue to lead the industry with our high-value innovative capsule and service offering. And let me share with you today why we are convinced that this strategy will be successful. Demand for hard empty capsules from both the pharmaceutical and nutraceutical markets is projected to remain robust, growing annually until 2028 at 2% to 3%. With a capacity of 260 billion capsules, the largest global capacity in the world, we are able to supply our customers in every major region with standard customizable capsules at scale and speed. In addition, we provide novel and functional capsules for increasingly the complex and sensitive therapeutic areas. With our strong position in Western markets and our focus on higher-value innovative offerings, we expect to grow in line with the global capsule market. With our DFS business, we offer our nutraceutical customers an unmatched end-to-end contract manufacturing service. We combine collaborative, innovative workshops with innovative technologies such as pellets in capsules and capsules. With our state-of-the-art and expanded formulation and production capabilities, we expect to grow above market. While we predict robust growth in our markets over the coming years, the industry has experienced unprecedented market headwinds and is managing through the aftermath of the COVID-19 pandemic. Consumers' focus on preventative health care triggered a pandemic demand peak for capsules in 2021. Demand growth and attractive margins in the capsule industry led to significant capital investment, in particular, in Asia Pacific. Due to limited capacity and supply chain disruptions during the pandemic, capsule customers experienced supply constraints and long lead times, which led them to qualify additional sources. Coming out of the pandemic, the industry is experiencing a softening of demand for both the over the counter medication and dietary supplements. We anticipate this to be a short-term effect with the nutraceutical market growing long term as people take a more proactive approach to health care and preventative treatment. Inflationary pressures have impacted costs for the key raw materials such as gelatin and HPMC, combined with rising energy and labor costs, primarily in Europe. While we are seeing energy and raw material costs stabilize, the cost increases have driven a margin gap. We are responding to the situation with various cost-saving initiatives. Customers are destocking in response to the market slowdown and using it as an opportunity to reduce their own cost and working capital. This is a onetime effect across our industry that we expect to normalize during 2024. Finally, as a result of capital investments and lower demand levels, excess capacity is driving some temporary top and bottom line pressure as the industry adjusts to this new market reality. Longer term, sufficient capacity will be available to meet the anticipated market growth without the need for further expansions. Over the coming years, we anticipate slightly higher growth of hard anti capsules in the nutraceutical market compared to the pharmaceutical market. Despite recent temporary softening of dietary supplement demand, longer term, this is a robust market. With relatively low barriers to entry, the nutraceutical market is particularly relevant to secure asset utilization, especially in an oversupplied market. CHI is uniquely positioned to both defend and capture market share in the nutraceutical market. While we aim at gaining share, we will not enter into a race to the bottom. We sell more than industry-leading, high-quality capsules. We also support our customers with value-adding customer and technical services and science-backed innovation. This enables them to launch differentiated products in a competitive market. For the Pharmaceutical segment, this is a robust market with high qualification and registration requirements. Our multidisciplinary teams are uniquely able to solve drug development and ingredient formulation challenges. We offer long-lasting partnerships through the complex pharmaceutical development process. From discovery to commercialization, we support customized delivery and encapsulation services for a broad range of active ingredients. Capital investments and lower demand have led to more idle capacity. While demand utilization is projected to increase, it will remain below the high levels seen during the pandemic. Excess capacity will persist, in particular in lower value, lower quality capsule markets. While Lonza's asset utilization is also impacted by lower demand, it remains one of the highest in the industry. This is because we specialize in high-value, high-quality capsules where utilization is notably higher, and we combine it with our industry-leading quality, customer and technical services. Whether nutraceutical or pharmaceutical market, we support our customers through every step of their product journey. Working in close partnership, our expert teams from different functions collaborate to provide a complete and integrated service that goes far beyond capsule supply. We lead the way with our quality customer and technical services and our ongoing commitment to innovation. Our customers tell us that we consistently exceed their expectations, and our Lonza Promoter Score is significantly higher than the B2B Life Science benchmark. We do this through our best-in-class offering, and our success rests on a proven track record of process, product and service innovation. It is our strategy to double down on these competitive strengths. On process innovation. We have a structured and comprehensive process R&D and CapEx program, focusing on productivity and automation for continuous process and network optimization. We are in the process of installing new proprietary hard capsule manufacturing technology. With this technology, we will increase individual line output by approximately 15%, reduce our carbon footprint and set a new product quality standard. We are also investing in various aspects of automation, including our visual inspection systems, which will improve quality and ensure consistently reliable capsule filling performance for our customers. As we focus CapEx on productivity and automation, we are investing at our most cost competitive sites and continuously look to optimize our global production network. Already today, our R&D and technology teams are looking at the next-generation capsule manufacturing technology to maintain and build on our competitive advantage in this space. Our experts are shaping the future of capsule innovation. On product innovation, we continue to strengthen our position as the most innovative capsule supplier in the industry. In recent years, our product R&D investment has focused on addressing urgent market needs. Our award-winning titanium dioxide-free capsules as well as our Enprotect capsules are great examples for our innovative capsule offering. The recent launch of our new enteric and protect capsule is particularly exciting. This pipe layer capsule withstands degradation in the stomach to support targeted intestinal delivery. This proprietary dual layer technology will allow us to support multiple applications such as live biotherapeutic, complex, targeted release and sensitive therapies. We are already exploring over 200 unique opportunities with our customers. As a science-backed innovation leader, we will continue to focus on bringing novel and functional capsules to market. We anticipate revenue from innovative capsules to outperform market growth and do that at a significantly higher margin. On service innovation, we work on innovative collaborations with our nutraceutical customers to deliver a tailored end-to-end product development and contract manufacturing service. This unique service offering is enabled by our proprietary capsule technology, formulation and encapsulation technologies and product design. Our current customer base consistently expresses high levels of satisfaction with our services and products. This is reflected in our robust pipeline of opportunities, an exceptionally high repurchase rate and an excellent new project win rate. In this context, we anticipate significantly higher than market growth over the next 3 to 5 years. Capacity expansions at 2 of our key sites are now complete and ready to support this growth. With customer centricity, excellent product and service quality and a continuous focus on process, product and service innovation, we have achieved robust financial results. CHI has consistently delivered a strong top line performance, boosted by the pandemic demand surge. We successfully delivered on our ambitious capacity expansion plans, enabling us to benefit from the pandemic demand spike. As a result, over the 2019 to 2022 period, we exceeded our low- to mid-single-digit growth guidance. We continue to deliver attractive EBITDA margins in an evolving market environment which has affected the entire industry. We navigated challenges through increased focus on our customers, value-adding products and services and improved operational efficiency. We were able to pass inflationary cost impact to the market, and margin dilution has been partially offset by cost saving measures. As the industry experiences temporarily low demand and excess capacity, we doubled down on our strength and focus on operational excellence. We are well positioned to win. For 2024 to 2028, we anticipate a stable global market environment, and therefore, our midterm guidance is low- to mid-single-digit growth. As demand stabilizes and customers increasingly look for value-added partnerships and services, our key differentiators uniquely position us to deliver market value. Our hard empty capsules business will grow in line with the market. Our functional capsules and DFS will boost this growth to above market. We are confident in our ability to deliver this top line growth as we continue to deliver our proven strengths. Over the next years, we will maintain a high network utilization and drive continuous operational improvements. We will deploy our new manufacturing technology and invest in process automation. These measures will increase product quality and drive double-digit productivity gains over the next 5 years. This gives us confidence to realize a 30-plus percent EBITDA margin in 2028. Finally, given the low level of CapEx required, we anticipate CHI's cash contribution will be around 20% of sales. This very attractive profile supports the group's cash generation capabilities and provides a solid foundation for the company's ambitious long-term growth trajectory. To summarize, in an evolving market environment as well -- as positioned -- we are well positioned for future success with over 100 years of capsule experience and a track record of industry leadership. For our loyal customer base, our highly qualified expert teams provide industry-leading product quality as well as value-creating commercial and technical services. With our new manufacturing technology, we are setting new standards for the future, leading product quality and increased productivity. With our strong focus on product innovation, we are well positioned to capture market opportunities and secure our competitive advantage. These competitive advantages will support us in delivering our midterm guidance and ensure our capability to drive long-term value creation for the group. With that, I thank you for your attention. And I hand over to Albert for his closing remarks.
Albert Baehny
executiveThank you, Christian. So this is the last one. Last slide. Thank you for being with us today. Thank you for listening. Thank you for your patience. We come to the closing remarks, and I hope that our closing remarks are fitting, are matching your own final remarks. . Our CapEx investments are focused on high-value modalities. And these modalities will remain the backbone of the pharmaceutical industry for the years to go. And this backbone is Mammalian, Microbial, Bioconjugates, including Small Molecules. But we are also securing the future and investing in new and innovative modalities. And we will continue to do it also some other profile with a lower margin. Our approach to capital allocation is highly disciplined, and this is key for the future success of the company. We put a lot of emphasis on capital and resource allocation. We are very confident that what we presented today will be delivered. We believe in the industry, we believe in our key strengths, we believe in our teams, and we are convinced that this is our commitment and which will be met. This is supported by excellent leaders and strong teams around the world. When I talk to colleagues in the industry, customers, stakeholders, we are indeed. We have a fantastic product portfolio. We have the best organized organization, we have a worldwide presence and we are delivering growth and quality of growth. And this will be maintained in the future. Even if there are maybe from time to time, 1 difficult or 2 difficult years, we are well equipped to deliver what we are promising today. With that, I would like to say thank you to the team for the preparation for the presentations, for their commitment. Thank you again to you to be here today, and we move to the Q&A session. So please join me.
Albert Baehny
executiveOver here, the first question? I think there was 1 hand.
Daniel Buchta
analystDaniel Buchta from ZKB. Maybe 2 questions. The first 1 on the new midterm guidance. Just to clarify, it starts after '24, basically. So that means the flat growth, if we include that in the midterm guidance, you're not guiding for double-digit or low 10% revenue growth, even though CapEx in the last couple of years was 30% round about and thus more than in the 5 years before. So despite that, growth is probably slower than in prior years. I mean, I'm not getting the math completely why that is the case. Is there something below the surface that I'm not seeing? And then maybe the second question on...
Albert Baehny
executiveWe answer your first question first. So Philippe, if you want to discuss, represent the midterm target please?
Philippe Deecke
executiveSure. So yes, so the midterm guidance starts with the base year being 2024 and guides to 11% to 13% growth for -- until 2028. So there's nothing hidden under the surface. I think we've shown you very transparently the different investment phases that we have and the contribution to growth that this will deliver. So I think we're actually very happy with the growth contribution. But again, 2024 is more or less flat years versus '23, but it's a very good organic base to show you our growth.
Daniel Buchta
analystOkay. And then maybe just second on Capsules & Health Ingredients. I mean if I hear that relatively low barriers to entry and also overcapacities that something in the other businesses, fortunately, is not the case. I mean, from a strategic point of view, how much sense does it still make to have this business within Lonza, especially the consumer part in that?
Albert Baehny
executiveFirst of all, this is an excellent business. It is a business generating 30%-plus operating margin. It is growing at Lonza at GDP plus. It is a stable business, generating high cash flow. Maybe the synergies with the other divisions are not evident, but it is part of our portfolio. It is part of our business future and we feel comfortable in maintaining and keeping this strong business generating fantastic cash flows. Bingo.
Richard Vosser
analystTwo, please. It's Richard Vosser from JPMorgan. First question, we've seen a number of cancellations or issues with customers in a row for the last couple of years. So how have you taken into account or factored in risks around customers for '24 and your midterm guidance, thinking about probabilities or anything you can help us with to give us comfort that those risks have been taken into account? And second question, just thinking about the changing business model from take-or-pay to more partnerships with customers. So what happens when a dedicated facility or a joint venture, that product comes to the end of its life. Clearly, that's beyond the 2028 forecast horizon, but how should we think about when biologics expiries in the 2030s, the early 2030s, how should we think about this from a long-term perspective?
Albert Baehny
executiveJean-Christophe, you are designated for these 2 questions, please.
Jean-Christophe Hyvert
executiveI mean typically, when we have dedicated contracts, it's multiple year contracts. And there are certain provisions in the contract in case of clinical failure if it's a clinical product or at the end of the agreement. So we have, as we discussed today, we have certain termination fees when this contract expire. And then ahead of time, when we know -- when the end date is known, we look at replenishing the pipeline. So we are managing it in 2 different ways. Clinical phase with clinical risk, we are handling through contract terms, including cancellation fee. Long-term contract commercial product, we have visibility. And here, we are managing the portfolio.
Albert Baehny
executiveI'll just repeat maybe what I said in my presentation, we have 2 type of long-term contracts. 1 type of contracts for multipurpose assets, take-or-pay type of agreement. And for dedicated asset, it is with termination fees. So this is our protection, among other elements.
Unknown Analyst
analystThank you. And thank you for the additional transparency into the business today. I wanted to ask 2 questions to make sure we're interpreting what you're saying correctly. First, on the underwriting thresholds for capital allocation. If we look back a few years ago, you used to describe the IRR threshold as 25%, then it was 15% to 20%. And now you've described it as 15%. Similarly on the ROIC, you used to describe it as over 30%. And now it's, I think, approximately 30%. What's -- what's caused the change there? Is it something on the capital intensity or the margin side? That's the first question, I can pause there.
Albert Baehny
executivePhilippe?
Philippe Deecke
executiveYes, I'll take it now. Look, I think this is purely communications, to be really honest with you. I think the threshold is 1 number. It's not a range. So I think both on the ROIC and IRR, we've decided to be precise. As you've seen on the chart, the returns on our projects is way over this 15%. So we do not go below that, but the threshold is really 1 number. So that's -- don't interpret more into this. It's just simple communication.
Albert Baehny
executiveI think in the past, we combined a range with a threshold.
Unknown Analyst
analystGot it. And the second question is thinking about the 2024 to 2028 EBITDA margin guidance. So typically, in the past, you've said that when the -- in the first 2 years that a plant or capacity comes online, it's the most dilutive to the margin, and you've got a significant amount of capacity coming on in 2024, 2025 between Visp and Portsmouth. I think it's over 130 kiloliters, so a huge increase in the Mammalian capacity. So should we be thinking that the EBITDA margins will actually go down first from the 2024 base? And then tying that to the chart you provided on Page 27, are those investments part of Wave 2 or Wave 3? And it's interesting, that chart shows almost no EBITDA loss or dilution coming from Wave 3. So maybe you could just provide some additional characterization on that, please?
Albert Baehny
executiveIt's okay?
Philippe Deecke
executiveYes, I'm fine. I know what you're talking about. So look, I think when we look at margin for the guidance, 24% to 28%, we said this will continually improve. So I think we -- this is not a straight line, as you know. And I think Gordon and some of my colleagues mentioned this, I think we have large campaigns. So it's not a straight line, but I wouldn't expect margins to go down. I would expect margins to go incrementally up until we reach that level in '28. So that's answer number one. And so number two, I think the dilution of the Phase III assets really come more after the 2028 period than before. So I think what you see until '28 is really the contribution of Phase I and II.
Unknown Analyst
analystAnd just -- just 1 other point. The Visp capacity that's coming on, is that part of Wave 3? Or is that Wave 2?
Philippe Deecke
executiveThat's Wave 2.
Unknown Analyst
analystOkay. That's Wave 2.
Sebastian Bray
analystSebastian Bray of Berenberg Bank. I have 2 questions. The first comes back to the midterm organic growth guidance of 11% to 13%. It looks as if the fundamental CapEx intensity of the business hasn't changed over the last 3 or 4 years of -- at least, correct me if I'm wrong. The growth CapEx as a percentage of sales probably was somewhere in the mid- to high-teens over the preceding period. Does this mean that this price deflation built into the forecast? Because if I look purely on this 1.0 to 1.1 CapEx to sales ratio and apply that to the growth CapEx previously, does it mean there's minus 1%, minus 1.5%, 2% per annum price deflation in those forecasts? I have a second question, but I'll pause on that one.
Albert Baehny
executiveYou take it. I can add something.
Philippe Deecke
executiveSo look, no, there's no price deflation built into this. I think, again, for the most part, we're talking here a million contracts where, as you saw, the supply and demand curve pricing is quite sustained. So no, we have not assumed price deflation on mostly Biologics business.
Albert Baehny
executiveNo, I'll just confirm what you said. I mean, to some extent, we have a certain pricing power, and we can basically give over the inflation cost to the market. With some delays, of course, so there is no price inflation.
Sebastian Bray
analystPerhaps to scratch up that, there may not be price deflation in nominal terms, but is there real terms price deflation in the sense that in the 11% to 13% target, I assume it's entirely volume-driven, but if price is 0 and the real value of the sales goes down over time? Or is that not the case? There is an inflationary component at bridge?
Albert Baehny
executiveJC, you want to comment? Because you are in charge of these big contracts.
Jean-Christophe Hyvert
executiveSure. No. I mean, we're pricing in line with market with our positioning, which is a premium positioning. In our forecast, it's not flat pricing. We're assuming that price would carry on, and it's rebased on market pricing.
Sebastian Bray
analystThat's helpful. And my second question was on the Capsules business. Have the capacity additions to this area now stopped in the sense that there are no more plants coming to an already oversupplied market? Or there's still a few more over the next 6 to 12 months before the shakeout is complete?
Albert Baehny
executiveChristian, please.
Christian Seufert
executiveSo we saw the majority of the capacity additions in 2021 and in 2022. Difficult to comment on competitors' activities. From our perspective, tracking announcements, this has slowed down.
Sebastian Bray
analystThat's helpful. And if I may squeeze in a third, dividend versus buyback considerations. What was the thinking, Patrick and Philippe, behind edging up the payout ratio slightly than building in -- rather than building in some type of recurring buyback program given the stock is quite heavily off its highs?
Albert Baehny
executiveWe like to offer you a combination between share buyback and dividends, and we feel confident in our balance sheet, in our cash generation in the future is why we decided to increase the payout ratio from 25% to 35% -- 45% to satisfy the various ambitions and requests from the market.
James Quigley
analystJames Quigley from Morgan Stanley. I've got a couple of questions, please. So firstly, in Biologics, you've got the same mid-teens target as you had with the last Capital Markets Day and with the last midterm outlook. But 80% of your growth CapEx has been going into the Biologics division. So why is Biologics not growing at a faster rate? On the slides, you had 13% growth over 2019 to 2022. And given that increase in the CapEx, I would have expected some increase. So is it slowing growth in the base business? Is it the base impact getting higher? Is it conservatism? Why is Biologics is not growing faster?
Albert Baehny
executiveJC? Yes.
Jean-Christophe Hyvert
executiveI think if you look what I showed today, you have 2 components within Biologics. There is a base business in bio with legacy assets. And as we discussed today, that base business has grown significantly in the last few years. Going forward, we are not expecting the same level of growth from the base business because it's a heavily utilized base business. So the growth going forward is really geared towards the CapEx and the investment. So the nature of growth between these 2 components is shifting. And that's really the primary driver behind that shift that you see.
James Quigley
analystPerfect. And then on the Cell & Gene therapy business, you highlighted that the increase in productivity in this business was one of the key reasons for the margin expansion. But to what extent do you have visibility on that? You mentioned another 4 or 3 or 4 products coming through in the commercial phases. There have been some disappointments with approvals and uptake of some Cell & Gene therapy. So to what extent have you added some conservatism in the guidance for -- for those types of factors?
Albert Baehny
executiveDaniel?
Daniel Palmacci
executiveSo as we pointed out, the main driver for growth in the Cell & Gene is, in fact, that the pipeline is now becoming commercialized. And it's pretty steep for us as we look at now 3 commercial products today, increasing additional 4 in the next 18 months. And that's the primary reliable growth driver for the Cell & Gene. And we believe we are very well positioned there. And we also anticipate that our pipeline will continue to crank out commercial opportunities as we see, that's exactly where we're positioned in. So we're very bullish about it.
James Quigley
analystPerfect. And if I could squeeze in a third. You mentioned, Albert, that the CEO search is ongoing. So can you -- again, I appreciate you're in the very early stages here, but could you give us an idea of the profile of the person you're looking for? And to what extent is the fact that the long-term targets are already set by the Executive Committee, by the Board today? To what extent is that a potential barrier or headwind to recruiting a high-quality candidate?
Albert Baehny
executiveSo to some extent, your answer to the first question, it's the early days of the search, I can't say more. What kind of profile are we looking after? We want to find a proven leader, a proven leader who has been successful in various roles and functions which are relevant to Lonza's business and to the industry. . In the past, we made twice a kind of mistake, and we hope that intelligent people, capable COO, could be able to transform themselves to become a successful CEO. We will try to avoid this mistake. So we want a proven leader who has been capable of showing his strengths and capabilities in various roles. And again, on the search process is just too early.
Peter Welford
analystIt's Peter Welford at Jefferies. May I...
Albert Baehny
executiveSo remember it. Sorry.
Peter Welford
analystMay I ask 3 questions as well, but I'll do them 1 at a time. Perhaps firstly, if we can just return to Slide 27, which is the CapEx chart that you showed. It looks as though that the absolute magnitude of CapEx is forecast to roughly remain sort of at the current levels throughout the sort of 2028 period. . But presumably, as you said, maintenance CapEx is going to at least be sustained, if not actually increase, given you talked about the need to refresh some of the sites, some of the suites need a refresh and rebuild. So when we think about CapEx in absolute terms, are we now thinking about actually CapEx is going to increase in absolute terms over that period? And we won't see the sort of perhaps slowdown beyond the current projects. Is that right?
Albert Baehny
executiveThe trajectory of the CapEx will come down. But you can add something.
Peter Welford
analystSorry, is that percentage terms, or...
Albert Baehny
executiveThe guidance -- Peter, the guidance is for the percentage of sales of CapEx to come down to mid- to high-teens by the end of the period. So this is what we're saying. So of course, the company is growing. And so it's not a 1:1 between the percentage and the absolute numbers.
Peter Welford
analystSo mid- to high teens by 2028?
Albert Baehny
executiveCorrect. High-teens percentage of sales. And so what you saw on Page 27, 28 is the gross -- it's not the total CapEx, it's the gross CapEx that we showed.
Peter Welford
analystAnd then secondly, on the margin. So if we take you back to 2020, we have 33% to 35% EBITDA margin by 2023. Clearly, then that was reset. Now we've invested a lot in growth projects. We've got more commercial stage. We're now at 32% to 34% by 2028. I get -- can you just talk us through over that 5-year period or 8 years, if you like, from when we started. What's fundamentally changed in the business for us to be 100 basis points lower than the prior midterm target despite the much greater number of growth assets?
Albert Baehny
executiveOne of the main changes between the past and the situation today is investments. We under-invested in the past. I'm not saying we are overinvested, but we invested what needs to be invested to be able to capture the market needs. And you have seen how it works with these investments. It's a kind of 7, 8 years investments. In the first year as you have CapEx, you have operating expenses and you have lower revenues than your margin. This is a main change between the past and where we are today.
Peter Welford
analystAnd then just finally, a quick one. Appreciating what we've seen with Moderna, and I guess we saw a similar trend last year with Allakos where we've got this sort of volatility, presumably as you do more contracts that are true partnerships to the customer where the customer can then potentially either fail or walk away or choose some other option. . What can you do to, I guess, reduce some of this volatility within your business? Or is this volatility, this sort of significant extent now part and parcel of the Ibex sort of dedicated model?
Albert Baehny
executiveI suspect that this kind of volatility is part of the business model, which is unavoidable. When you develop a drug -- a drug, a new therapeutics, you have a cycle of 10 years. And during this 10 years, you start with preclinical, clinical Phase I, II and III, and you never know how it will end up in clinical Phase III. So this is part of the risks which we have in this model. But these risks are limited with this long-term contract, either for multi-purpose assets or for dedicated assets. But it is part of the business model, part of our business, we can't avoid it.
Charles Weston
analystCharles Weston from RBC. I'll ask the first 2 together, please. In terms of 2024, there's a 3% or so headwind from Moderna and the 200 million fee for this year. And then there's a bit of a headwind for Kodiak. But underlying, there's sort of high-single-digit growth. So what's the difference to get us to roughly flat for next year, which is the indication? And just as a sort of separate part of that, I think you said -- or I overheard Albert talking earlier that the Moderna -- the visibility into the Moderna contract cessation was sort of 2 or 3 years. Are there any other large contracts that might be coming to an end over the next 2 or 3 years?
Albert Baehny
executiveCan you take the first part of the question?
Unknown Executive
executiveSure.
Albert Baehny
executiveModerna, by the way, I didn't say it's 2 or 3 years. What I said is that we knew with Moderna that is 1 point in time, this mRNA related vaccine business will go down. But we didn't know if it is 2, 3, 4 or 5 years, but it was clear to us at 1 point in time, the pandemic is over. So this business is going out. But we had no clue on the timing, of course, at the time when we signed the basic contract with Moderna.
Unknown Executive
executiveCharles, to your first question, I think, again, looking '23 to '24, you have 2 items on Moderna. You have the termination and you have the base business. So looking year-over-year, you lose the base business and you have the termination effect. And then you have, I think, the expected impact from Kodiak. So this translates the high-single-digit underlying growth that we would show to basically more or less flat. And so what exactly it's going to be, I think give us a couple more months, we'll come back in January, giving you precise guidance on '24. But as of today, it's what we see. And I think, again, it's important to note that the 21 to 24 growth guidance would be met, excluding these events that we mentioned today.
Charles Weston
analystOkay. Thanks. So Moderna...
Albert Baehny
executiveNow we have to -- you have another question?
Charles Weston
analystJust 1 more, please.
Albert Baehny
executiveBecause then we have to move to online participants. So last question from the room.
Charles Weston
analystSo it's sort of a similar question to perhaps some of the others. Thinking about your revenues this year, about CHF 7 billion, maybe next year, CHF 7 billion as well. Most of that is from that base business that's not going to grow very fast, maybe alongside inflation. So over 4 or 5 years, maybe an extra CHF 1 billion. So your underlying growth of low teens implies that you're going to get essentially another CHF 3 billion of revenue on top of that. So from today, another CHF 3 billion of sort of volume-based and another CHF 1 billion of pricing-based revenues. So that's CHF 4 billion from your -- on top of the current sort of base business, but you will have invested something like CHF 10 billion from 2019 to 2026. So should we just assume that there's some sort of further delay in some of that CHF 10 billion or CHF 11 billion of revenue from the growth CapEx coming through post-2028?
Philippe Deecke
executiveShould I take...
Albert Baehny
executiveYou take it. We'll add something else.
Philippe Deecke
executiveSo Charles, I'm not going to recalculate your spreadsheet in my head. I think what's important to know is, I think once we build these assets, and we showed you 2 examples where the peak of these assets come 5 to 7 years after we start constructing them. So once we reach that peak, these assets keep on going for a long, long time. I think Gordon was mentioning, we've been producing some of these things in assets that have 20, 30, 40 years old. So I think these assets don't stop producing value post that. And so I think you can assume these assets to continue to grow post '28, especially the Wave 3 assets would continue to grow post '28 and they will deliver for a very long time.
Albert Baehny
executiveI hope I said -- I hope you say it because it's what I wanted to say. This is long-term investments. It's not because the reach of the peak that it is stopped. It will continue. So we have to take questions from our online participants. David, you organize it.
Operator
operatorThe first question from the phone conference is from Vineet Agrawal with Citi.
Vineet Agrawal
analystFirst, I just wanted to understand your appetite to engage in peptides manufacturing given the super normal cohort you're seeing there and a lot of past experience in this segment. If yes, can some of your capacities be repurposed towards that? And if no, then I would be interested to understand your thoughts behind that. And then the second question...
Albert Baehny
executiveOne second. We'll answer the first question, but...
Unknown Executive
executiveAcoustically, it was difficult...
Albert Baehny
executiveIt was difficult to understand your question. So it's why I stopped you here. Can you start again? The acoustic is bad.
Vineet Agrawal
analystWell, can you hear me now?
Albert Baehny
executiveWe can hear you, but the quality, we will see. Go ahead, please.
Vineet Agrawal
analystOkay. No, I just wanted to understand Lonza's appetite to engage in peptides manufacturing...
Albert Baehny
executiveNo, it doesn't work. It doesn't work. We can't understand your -- what you are telling us. Sorry for that. We move to the next question. So who will be next?
Operator
operatorThe next question is from Balasubramanian Nithya from Bernstein.
Nithya Balasubramanian
analystThank you for the question. I have 2. The first one is, you have a large CDMO guiding to almost 20% growth in the near term in Biologics. There is a similar period, again, focused more on the early stage assets who is also guiding to a 30% growth in Biologics in the near term. When I look at the low-teens growth or mid-teens growth you're guiding to in Biologics, does it mean that Lonza's losing its precision at the premier CDMO? Will they be gaining share at the cost of Lonza?
Albert Baehny
executiveJC, I suspect it's for you. I hope you understood the question. Otherwise, you can read it.
Jean-Christophe Hyvert
executiveI'll read it. Just 1 second.
Albert Baehny
executiveSorry for that. Sorry, the tone is difficult. Okay.
Jean-Christophe Hyvert
executiveSo the question, to be sure I have it right, is growth in Biologics is near term -- in near term is focused on commercial and secondary and clinical? What is the difference in split? Are we losing market share in clinical?
Albert Baehny
executiveOkay.
Nithya Balasubramanian
analystNo, sorry, that was not my question. My question...
Albert Baehny
executiveSo I suspect we have a problem in the line.
Nithya Balasubramanian
analystLet me try and rephrase it, and hopefully, it's clearer this time. Your peers, closest peers in biologics are guiding to much higher growth. You have a commercial stage-focused peer guiding to a 20%-plus growth. You have a clinical stage-focused peer guiding to 30%-plus growth. I'm talking in the next 2 to 3 years. And in that context, Lonza's growth seems weaker in biologics. If you can help us understand why that is the case. And does this mean Lonza is losing ground as the top CDMO in biologics?
Jean-Christophe Hyvert
executiveI think I get it, and I'm going to try to rephrase it again to be sure it's right. Closest peer in bio are much higher growth. You have a clinical stage focus. In that context, Lonza seems to have weak growth. Are you losing ground in biologics? So I think the answer is we are not losing ground in biologics. You've seen the growth in molecules that we have, and you see the above-market growth in bio. I would like to be -- to clarify 1 point, our focus is not on clinical. Our focus was on building a clinical pipeline. We are commercial and a clinical company. And really, what we wanted to have is a pipeline of molecules across cycle, which help us derisk investment in the future because your commercial pipeline is fed by the clinical pipeline. So there are -- we are clinical and commercial. And really, the pipeline that we've built in the last few years is approved or is a tool to build further commercial success. I hope I answered -- is that the question?
Nithya Balasubramanian
analystI'm so sorry, I'm going to try 1 more time. My question was on your growth compared to your peers. And why is that slower?
Albert Baehny
executiveYour growth compared to your peers. And why is it lower than our peers' in clinical. That's the question. So why our peers which are mostly clinically focused growing faster than we are.
Nithya Balasubramanian
analystNow both your clinically focused peers and commercially focused peers are guiding for faster growth than you are.
Philippe Deecke
executiveBoth peers are growing faster. Why is it?
Jean-Christophe Hyvert
executiveBoth peers are growing faster? What is it? I mean, I think our peers, like we do are investing heavily. So I mean, growth is a function of investment. I think we have made the choice to invest across all phases in clinical and commercial. So what we have built is really a pipeline and strength. Now if some -- I mean, some of our peers are growing faster, look at -- I mean, I'll leave some of that to you. I think we are growing faster than the industry average. Some people are growing faster. It means some people are growing slower. And really, I feel strongly that what we have built is a strong portfolio for future growth because we have that pipeline that will derisk the investment.
Albert Baehny
executiveThank you, Jean-Christophe. David, the communication line is really bad. Do we continue with this exercise? Or we stop it? So you have a good question? A clear question? So this is a question from Vineet. And the question is what is our appetite to engage in peptides. Not surprised with the question. Today, we are not producing neither drug substance nor drug product on peptides. Today, we have no capacity. We have no assets to produce peptides, but we have some businesses ready to peptides, and it is in your hands. Gordon, can you say a few words, please.
Gordon Bates
executiveYes. We manufacture an excipient that's used in GLP-1 products that are existing commercial. So it's not drug substance, not drug product, but it's an excipient as part of the supply chain.
Albert Baehny
executiveThank you, Gordon. So the answer is clear. We are participating to this fantastic growth rates of GLP type of therapeutics, but we are not in the drug substance. But we have fill and finish capacities now and in the future for this growth business.
Unknown Executive
executiveThere's the next question.
Albert Baehny
executiveOkay. Sorry, you are again. Go. Vineet, you have to read the question for the audience.
Unknown Executive
executiveSo Biologics guidance is implying a market share gain of 300 to 400 basis points. Now with WuXi order book continuing to grow despite geopolitical concern and additional capacity from players like Samsung, Fuji, [ Lottery and Baby More, ] what is your view -- what in your view would drive market share gain?
Albert Baehny
executiveI say 1 word before you start the answer. We don't comment on competitors. But you can -- if you want to answer.
Unknown Executive
executiveI will happily answer.
Albert Baehny
executiveWe do it, but we don't comment on competitors.
Unknown Executive
executiveI mean, I think what drives market share gain is what I mentioned before. We have a unique position. People are coming not for 1 specific services, but for end-to-end offer for complex problem to solve. And here, we have very strong demand. I think I'm confident to say that we have demand higher than market average. Upfront in my presentation, I'll give you example of 3 contracts that we entered into Q3 that are exactly demonstrating that and the value of this contract together is in the multibillions. So really, the point to keep in mind is, we are competing by differentiating ourselves, and that's why we are gaining that market share. The pipeline that we've built, the offer that we've built is what gives us the confidence that we'll gain that share. And if you look at the molecules win we had, we are growing in excess of market.
Albert Baehny
executiveSo thank you for the question. We are closing this morning session. Again, thank you for being with us during this. Thank you for your patience. Thank you for listening. Hopefully, you appreciated our presentations. We wanted to be as transparent as possible for you. We wanted to describe, to show you the fundamentals of this business. We are a fantastic company. We're in a fantastic industry, and we are convinced that we have a bright future in continuing to do what we are doing. Thank you for that. We'll have a short lunch, and then you will be discovering these billions of investments in this with your own eyes. Thank you very much. Talk to you later, and we have lunch together. Thank you.
Unknown Executive
executiveThank you.
This call discussed
For developers and AI pipelines
Programmatic access to Lonza Group AG earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.