All right, let's get started. Good afternoon, everyone. Welcome to day one afternoon of the JPMorgan Healthcare Conference. I'm Julia Qin, lead analyst covering life science tools and diagnostics at JPMorgan, and it's my great pleasure to introduce you to our next company presentation by Catalent. Now with that, let me turn it over to them. Thank you, Julia. Afternoon, everyone. Welcome, and very glad to be here to present Catalent's story. Before we get started, before we begin, I would like to call your attention to page two and three of our presentation with regards to our use of forward-looking statements and non-GAAP financial measures. As well as I would like to invite you to read our SEC filings with regard of risks and uncertainty that can bear our future operating results and our financial conditions. With that said, let me start from our mission, right? At Catalent, we have a very, very clear mission, which is to help people live better and healthier lives. I guess that this mission never came clearer in the history of the company as it was in the last couple of years during the pandemic where Catalent really helped to the response, and we are very, very proud of the work that we have done together with our partners to be able to have this. I know it feels a little bit uncomfortable today, but you know, to have this live presentation since a couple of years. In fact, I estimate that among you, the ones that are vaccinated, probably half have been vaccinated with the vaccines that were manufactured at our facilities. Clearly, we do not accomplish this mission that is stated on this page alone, but we accomplish this mission together with our partners and customers. Really, what we have endeavored to do in the last few years, is to build for those partners, an ecosystem that help their innovation to deliver better patient outcomes. We are a differentiated CDMO. We differentiate ourselves for the breadth and the depth of our offering with specific regards to our development capabilities, our delivery technologies, and our multi-modalities manufacturing capabilities. But look, today we will try our best to get all of you excited about our great market, our set of capabilities and the talent, which we have in the company. What really makes Catalent special is our culture, Patient First, which underpins everything we do and how we do it. This really materializes in our uncompromising commitment to quality and compliance and operational excellence through which we guarantee that a significant number of products, nearly 8,000 products, gets on the market on time and with the right quality. Patient First goes deeper into the organization. We really have an expectation from all the associate of Catalent. The expectation is, number one, that they realize that behind every dose that we manufacture and supply, there is a person, an individual that has a need. Moreover, we have an expectation that every associate is able to ask themselves the question of whenever making decisions, impactful decisions, or asking themselves the question, "What would be the impact of this decision on this very patient?" We invest a lot in creating this culture. We believe it's a differentiating factor of our organization. Our impact on the public health would not be well explained if I wouldn't point you also to the very sizable organization of scientists that we have around the world, more than 3,000, that every day work with our partners in resolving challenges and problems which are typical of the formulation development of new drugs, and helping our customers to bring an idea and innovation to a patient outcome. Of course, because of the work we do, we get scrutinized all the time by customers, by ourselves, but also regulatory bodies. I will point you to the 300 regulatory inspections that we received just in the last five years, of which 54 did happen in fiscal year 2022. We are uniquely positioned to the center of the pharmaceutical services ecosystem. When you look at the breadth of the services that we provide, we have one vision. We want to make sure that every innovator that is out there, large or small, can come to us and find everything they need to move their innovation across the clinical stages and commercialize their products with a set of very comprehensive capabilities, going from formulation and optimization, helping our customers to design and support their clinical trials, manufacturing for them the clinical material. Also manufacturing for them their commercial products, helping them with very complex analytical services that are required in our industry, specifically for large molecules. We applied this set of unique capabilities, participating to a number of very exciting areas and therapeutic areas. Legacy small molecule, more traditional therapeutics, also more advanced one, proteins, biologics, gene therapy, cell therapies. We also have in our portfolio a set of unique and premium formulations for consumer health, which really provides differentiation and competitive advantage to our customers, specifically I refer to softgels and gummies. When I try to put our diverse portfolio more in numbers, this is a very interesting page. Let me drive your attention first and foremost to the market position of the company. I'm gonna get a little bit more in the details of what is our market. In most of the markets we play in, we are a leader. We are either number one, number two, or number three by market share in most of the areas where we play in. In fact, giving a little bit of additional color to these, in the last five years, where you count the number of FDA and EMA approvals supported by CDMO, Catalent ranked either number one or number two by approved products in each of these five years. We are trying to give you also here a little bit of a breakdown and visibility on the portfolio of the revenues. I'm gonna get a little bit later in our reported segments. This is a view of the company by geography, product type, products, and type of activities. First of all, these are numbers referred to the past fiscal year, which is now already 6 months in the past, okay? Our fiscal year ends in June, so these are numbers referred to the fiscal year which ended 30 of June 2022. By geography, you know, this is pretty common for Catalent. We are 60/40. 60 U.S., 40% outside of U.S. Outside of U.S., Europe is surely the main geography we play in. From a product standpoint, from a product type standpoint, we have really reached a very good exposure to biologics and new modalities with the current above 50% share of our revenues coming from this source. Just to put this a little bit in the context, at the time of the IPO, 2014, that percentage was 14%. That increases the result of $7 billion of capital deployment since fiscal year 2017 to really increase the share and participation of the company to the exciting biologics pipeline. When you look at the product concentration, more than 40% of our revenues are coming from the top 20 products. Of these 44%, 27 percentage points are related to COVID programs. Again, this is a picture related ending the 30th of June 2022. As we have shared in the last few earnings, these percentage of COVID programs has reduced, but at the same time, we have seen an exciting growth from the non-COVID programs, which in our last few quarters has seen a growth of in excess of 20% on an organic basis year-on-year. When you look at the type of activities, half of these activities are really related to the development work. This is the work, again, which we do on behalf of our partners to bring their innovation to the patients. The other half of the company is either supply services for clinical trials or manufacturing services for commercial products. Moving to our reported segments. This is the way we report companies. Again, these are fiscal year 2022 revenues. The company's really reporting two main segments, Biologics and Pharma and Consumer Health. They play a very distinct role in our portfolio. Biologics, which is 53% of our revenues with a 31% EBITDA. The role of Biologics is really to be a growth accelerator and a margin enhancer for the organization. At the same time, it's also attracting most of the capital deployment that we have into the organization. Here we have built a comprehensive set of capabilities end-to-end, from drug substance to drug product, bioanalytical services, cell and gene therapies, becoming a powerhouse of the biopharma ecosystem. The Pharma and Consumer Health plays a little bit of a different role in our portfolio. This is the place where most of the revenues, which represent the 47% of the overall revenues of Catalent, are coming from commercially approved products. This is a segment which tends to have less variability on a quarter-to-quarter performance basis, which you will see sometimes in the clinical work you do in the new modalities. It's also because it's more mature in nature in terms of the assets and utilization of the asset, it's also a good source of cash flow for the organization. Also here, we have a leading position in the most exciting areas, complex, advanced technologies, differentiated dosage form like Zydis, analytical services, and formulation development services. We are probably the CDMO with the broadest set of bioavailability enhancement technologies that can help reduce, resolve bioavailability challenges for molecules. These set of capabilities really put us at the center of the biopharma ecosystem, helping our customers to bring their innovation to patients. Before I get into the specific a little bit of our market, I wanted to give you a little bit of view on how the CDMO have transformed in the last three decades. When you look at 30 years ago in the 90s, I should speak there more of a CMOs than CDMOs. CMOs were really much more of an opportunistic play for the pharma industry. Number one, as you see on the top, 45% of the pipeline was really concentrated in the top 25 biopharma players. These companies are vertically integrated. They have internally most of the capabilities that are required from the early stage all the way down to commercial manufacturing. Really, with such a percentage of the pipeline in those companies, CDMOs were either used for offloading legacy products to free up capacity for new pipeline or for technologies that you wouldn't have in your portfolio. That was very much Catalent back then, okay? With our Zydis, softgels, we're really complementing the internal capabilities of the pharma companies. Then there was an inflection point around the mid 2000s. Venture capital funding was coming into the place. The pipeline started to migrate much more towards biotech, small virtual organization, which had not only manufacturing needs, but also development needs. This is where CDMOs transition, some of them, the biggest one, transition to be CDMOs, adding development capabilities which will help customers not only to manufacture product, but also to resolve the challenges typical of the development and clinical phase. Then we come to nowadays. Nowadays, CDMOs are a critical strategic part of the ecosystem. When you look at the new modalities, like they are very exciting, they attract a lot of value, but the reality is that they are all have in common that they have, they are targeting a very small patient population, each of those, difficult to manufacture and very asset heavy. In order to have a good return on capital and to generate, good level of cost of goods, the only players that are positioned to achieve utilization rates, which will give return on capital and cost of goods in the right place, are in fact the CDMOs. With the pipeline now shifting from 45% in the big, in the top 25 to 8% nowadays to the top 25, you can see that the positioning of the CDMOs, and especially the ones that have the portfolio, the breadth of the portfolio like Catalent, are very well positioned to capture the very exciting trends of the pipeline of the biopharma space. What does it mean for Catalent? Well, as I said, Catalent went through a significant transformation in the last several years. We deployed $7 billion of capital to transform the organization, making sure that the organization got exposed to the most exciting segments of the pipeline. Our addressable market just before the pandemic was estimated to be $35 billion. Through the investment we've done just before the pandemic and through the pandemic, we managed to double that number. Our addressable market today is estimated to be $72 billion. You can see that the slices that we've added to the pie are very exciting. Cell and gene therapy, plasmids, we have increased significantly our presence in sterile fill and finish, becoming one of the largest players into the space. Because these areas will experience a significant growth of the pipeline going forward, we estimate that there will be an additional 40% expansion our addressable market by fiscal 2026. This is a very exciting market for us. This is the market evolution that led us from being a mid-single-digits grower before this transformation to what is today a high-single-digits, low-double-digits growth story. We're all very excited about these prospects for Catalent. When, when you try to bring these into our reported segments, our expected long-term organic consolidated growth is in the range of 8%-12% because of the dynamics I just shared. As I said, the two segments will play a little bit of a different role here. Biologics will be faster-growing in the low double digits, mid double digits, and our PCH segment will be a nice single digits grower. As we've done in the past few years, even more so, we're gonna have a purposeful allocation of capital. We're gonna be very purposeful in allocating capital to enable growth, but at the same time, delevering the company to a target at 3x adjusted EBITDA. We have now all the assets we need to capture the opportunities of our expanded market, and our focus will be on generating the utilization of those assets and improving cash flow generation. As I now bring everything together, Catalent is a differentiated leading CDMO, first and foremost, because of our Patient First culture, which underpins our commitment to quality and operational excellence. We are a leader by market share in almost every area we play in, occupying either number one, number two, or number three position by market share. Through the investment and transformation we have done in the last few years, we have expanded our addressable market from $32 billion in fiscal 2019 to an expected $100 billion in fiscal 2026, a threefold increase. Through our cutting-edge science and innovation, we can continue to have that competitive advantage that will give us the opportunity to leverage the great dynamics of the market to grow the organization. As I said, we're gonna increase our utilization of the assets that we have built. We're gonna continue to expand our margin and improve the cash flow generation of the company. We are in a great market. We have built a great set of assets, and we believe we have the best talent in the CDMO industry. That gives us the excitement we have for the long-term prospects of this organization. Thank you. Thank you, Alessandro, for a great overview. Sorry. Just a reminder for the audience, if you have a question, feel free to raise your hand. There's a mic going around the room, or you can submit your question through the digital conference book. I can get us started. You know, first of all, I wanna congratulate you on the Sarepta commercial gene therapy deal that you announced just prior to the conference. Maybe we can, you know, help us think about how to think about the magnitude of the volume scale-up as we move from phase III to commercial, and then, you know, any color you can share regarding the pipeline of any other such arrangements that's in discussions? Is it on? Yeah, sure. Look, number one, we are very, very excited about our partnership with Sarepta. Clearly, the most visible part of that announcement is the program for Duchenne, which is a leading candidate, but there is also other programs in the pipeline in the partnership, which we are very excited about. I will tell you that, you know, clearly, Duchenne represents those areas with one of the largest patient populations. It's surely an exciting program for us and for our customers. We continue to work diligently to prepare for a potential launch and as well as to continue to support Sarepta through the review process. It's all very, very exciting, and surely the promise for the patients when I look at and I think about some of the patient testimonials we were able to experience and to see in the videos are heartbreaking. When it comes to purpose, when it comes to our Patient First story, I believe that enabling the opportunity to give an hope of life to these young kids, it's super exciting. This more than anything else. Is there. I believe that, look, when I look at the progress that we've done in gene therapy, when we really acquired the Paragon asset, there were really, you know, two main CDMOs, and we made great progress. Clearly from a commercial manufacturing of gene therapies, we already had one product approved with us, which was approved a couple of years ago. Surely we've made great progress to be really in the, in the leading position when it comes to provide the solutions for gene therapy customers which are heading towards commercializing products. Great. Now looking at more near-term dynamics, you know, the spike in COVID incidences, lots of masks in this room. You know, are you guys seeing any changes in, you know, vaccine demand in your fiscal, you know, second quarter? Does the math, you know, previously guided to $700 million, $15 million of vaccine roll-up headwind, does that math still hold in your outlook? Well, what I would say is that, look, we need to understand that some of these supplies of vaccines, are made under government contracts. Not necessarily the supply, the short-term supplies are governed either way, you know, the good or the bad, by the demand. I don't believe that we should be seeing necessarily a very short correlation between what you're seeing, on the charts and what you see, from a, from a supply standpoint, that there is a stock out there. I, I do believe, look, when it comes to COVID, it's hard to predict, in terms of the dynamic of these. There are some baseline assumptions which are really consolidating there. Number one, the fact that this is gonna be more of a seasonal product. Number two, that it's gonna be probably coincidental with the flu. Number three, that it's gonna be, you know, baseline, it's gonna be associated with the risky populations and so on, and more mutations are gonna come, so there will be a need to update. I believe these are pre-consolidated facts, so we keep planning around them. We continue to be very excited about the collaboration we have with our partners, which are well known. We continue to make good progresses with them and achieve great successes as the launch of the pediatric formulation. I believe that, you know, it's remained to be seen in terms of the long term. Yeah. I would just add that we did add some further disclosure around the specifics of the COVID-related demand Alessandro mentioned in the presentation. For fiscal 2022, when you look at the percentage that was there, that would equate to $1.3 billion worth of COVID revenue that we had in our fiscal 2022 year. We've also talked about a significant decline that we're seeing in fiscal 2023 to the tune of $750 million is the headwind that we're facing on the COVID side of things. In terms of the quarterly phasing, our second and third fiscal quarters are the quarters where we're going to see the largest year-over-year decline as Q2 and Q3 of our prior fiscal year were peak volumes for us. Did wanna just ensure that that point was clear from an investor standpoint. Great. Now with that out of the way, let's get back to the base business. Any update you can give us in terms of booking trends for the non-COVID business? Well, look, the non-COVID, these programs, you know, are take time. As I said, we continue to be excited about the progresses in our gene therapy, which is non-COVID. Also, our sterile fill and finish program progress at pace in a number of our facilities for very interesting products. Some of them are already commercial, some of them have the ability to grow even further with extended indications. With regards of some of our offering in the small molecules, we are seeing, we continue to see success in securing more programs. I believe that, clearly, these programs, at, to the extent that they're gonna continue to be in the clinics, they can cause some variability, in the short term, but clearly, the pipeline we are very excited about the pipeline that we have in our facilities, and also the quality of them with the assets like the one we discussed before. We've seen growth over the last two or three quarters actually on a non-COVID basis in excess of 20%, which is well above the long-term growth outlook we have from a non-COVID business standpoint of 8%-12% for our consolidated company, 10%-15% for our biologics business, and 6%-10% for our PCH business. We have been seeing consistent growth well in excess of our long-term growth outlook on a non-COVID basis, as I said, over the last three quarters or so. Just sticking with that point for a little bit. Obviously, your biologics portfolio has a higher mix of clinical stage projects versus commercial compared to some of your CDMO peers. That obviously is a great positive in terms of supporting the long-term growth opportunity. In the short term, like you said, it also makes you a little more exposed to near-term pipeline volatility. How would you overall characterize the risk profile of your biologics pipeline? What's your visibility like? Any color you can share regarding, you know, the phase I, II, III mix in your pipeline? Sure. Number one, I would say that when you look at biologics, a significant portion of biologics is drug product for us, right? We bundle everything under biologics, but a significant portion of it's drug product. In drug product, the largest majority of revenues are coming from commercially approved products, so late stage tech transfers. I wouldn't characterize that piece of biologics as to be significantly exposed to the variability of, or the fluctuations of the pipeline. I believe as well, when you look at the gene therapy space, well, gene therapy have a dynamic which is, a very long cycle between when you start the work and when you actually, end up providing the programs, the products and the material, even on the clinical space. The, you know, the booking of the slots tend to be well in advance because of this situation. There are peaks, there are situations where sometimes from when you start the first, you know, thaw of your initial material and where you are of the drug product ready could be 10 months, right? It's a very long process, somewhat something that we need to work on to optimize, especially when it comes to the analytical work that is done through the process. I would say that on that front, there is quite good visibility because of this dynamic of the long time to supply. I believe really, you know, where you can see a little bit the short-term more variability, it's more in the drug substance and the cell therapy space for a couple of different dynamics, right? In the drug substance, we have seen some of these materializing. That's why we also took the decision of reviewing our investment in the Oxford facility in the U.K. as we have publicly announced, you know, slowing down the pace of investment and really taking a pause and understanding what was the best way to use this premium asset, right? If the initial choice of using it for protein still holds, given the opportunity we see in some areas and some of the dynamics we're seeing in these other areas. This is, I believe, the area where, you know, you can see a little bit more volatility when it comes to... or more than volatility, you know, quarter-to-quarter variability in the performance. Cell therapy continue to be fairly small in our overall portfolio. I believe that there will be, at some point, an inflection point there with the commercial therapies coming to fruition, but the timing of those dynamics sometimes is hard to predict. Again, I wouldn't picture everything as, you know, clinically exposed. I know you're trying to take a more kind of a prudent and conservative approach to your guidance, so can you know, help us understand how much discounting or haircut are you currently embedding in your guidance regarding the pipeline demand? We're not gonna provide an update, obviously, on guidance at this time, or on the second quarter. We'll give a lot more specifics around that in our normal quarterly call, which will be in early February. Going back to the guidance that we issued in November, on November first as part of our Q1 earnings release, we did lower our guidance both from a top-line and bottom-line perspective based on some macroeconomic factors where we're seeing, I would say, one, on the consumer spending side and the impact we saw around discretionary spend as it pertains particularly to our consumer health, vitamins, minerals, supplements, and nutraceutical business, as part of our pharma and consumer health segment. Also some of the slowdown in, I would say, decision-making, based on some capital conservation approaches we were seeing from some customers in terms of the pace in which they were looking to move certain development programs on the biologic side, particularly as it pertains to our cell therapy business, our drug substance business, and our plasmid DNA business, primarily. I would tell you our approach to guidance was to take the new information that we had available to us based on what we were seeing from certain customers, factor that into the revised guidance, but also make an assumption that things from a macro standpoint were likely to get worse before they got better. You know, so we certainly tried to factor all of that into the revised guidance that we provided in November. Great. One more on the biologic side. It's certainly great to see you resolve the Form 483 situations recently. Would you say, you know, that now sets you up better to deliver upside to your initial fiscal year outlook? Has that, you know, resulted in any meaningful improvements in customers' perception about your quality and things like that? Well, number one, I would say, look, you know, clearly, the unwanted, the undesired coverage of these Form 483s, which was very much related to the products which were linked to that, you know, caused the community here to be more aware of something that we'd always been aware in our industry, which is the dynamic around this inspection and Form 483s, right? I do believe that when you get these Form 483s from a customer standpoint, you want to see a partner which is in the position, both from a balance sheet standpoint, a cash standpoint, and capability standpoint, to be able to deploy the best possible response to these Form 483s, so that the whatever regulator is fully convinced that you're gonna address it, that you're gonna say what you said you're gonna do. Because that's what really matters. It's not the Form 483, it's the response to it and the final outcome. As shared publicly, in both cases, we got the VAI, which is essentially the conviction that the agency had that our responses were solid and the fact that we were a reliable company deploying them. I would say that that goes a long way to the fact that our customers, probably different from other constituencies, are well aware that this is the industry we operate in. Really, you know, they want to see this happening, that you take it seriously, you respond in an effective way, you avoid further escalation. Sometimes also to our customers, it happens that they cannot avoid further escalation. It's. Even in the presence of Form 483s that tend to be maybe a little bit more serious, the company is able to take the best possible approach to address them, which we've done, so we are very pleased with the outcome and with what we have shown, I would say, once again to our customers in terms of our ability to navigate these situations. Awesome. I'll make a short pause to see if there are any questions from the audience. Yes. Yes, in the back. Hi. Slide 10 of your presentation shows a fairly meaningful move away from large molecule drug substance, which is an area which your competitors are investing very heavily in. Love to understand why you're going the other way. Thanks. Do you want to repeat the question? I'm told that we need to repeat the questions. Yeah, feel free. The question is in and around our slide ten and what is apparent to be a move. Maybe we can pull the slide ten up and the drug substance. I wouldn't say that there is a move away from drug substance. It's all matter of a relative, you know, size, and what we expect in terms of growth going forward. Surely, at this point in time, when you look at the relative growth, we see higher growth rates in other areas of biologics, you know, in drug products, specifically when it comes to prefilled syringes, and also with regards of gene therapies and cell therapies, plasmid DNA. All these areas will grow with a growth factor which is significantly higher in our estimates from drug substance. I believe when it comes to drug substance, our view is that this will become a much more of a technology play than a capacity play going forward. The capacity is clearly catching up with the demand. It's less unbalanced than it used to be. Really this has been the competition in order to keep margins and good pricing will be on high-end solutions for products. In that regards, we have invested since a while in that, and our GPEx Lightning technology and platform really provides us a competitive advantage when it comes to titers, time to market, and quality of the clones. Really, we're gonna be more and more a technology player there, providing better solutions to customers, also to complex monoclonal antibodies, more complex ones. That's why, you know, it appears to be the case, but I don't want this audience to be misled. We continue to be very excited about drug substance. It's just that the rest is growing even more than that. With that, we're out of time. Thank you everybody for joining. Thank you so much for being here. Thank you.