Hi, good morning, everybody. Dave Windley with Jefferies Healthcare Equity Research here again. I cover the contract research and contract manufacturing space, and a leader in that space is Catalent. I'm here to present next, ticker CTLT. The management representatives here to talk to us about Catalent are CEO John Chiminski, newly appointed CFO Tom Castellano, and Paul Surdez, VP of IR. So we appreciate your attendance. Thanks so much for being here. I'm going to start, John, with you just to talk about Catalent's come a long way in a year. Maybe talk about the journey you've been on and things that have kept you busy and where you see Catalent competitively positioned at this point. Yeah, so thank you very much, Dave, and great to be here with you. First, I want to say I'm just incredibly proud of the Catalent team and their tireless work over the last 15 months. They've kept all of our sites operational. They delivered essential medicines. And obviously, they've played a significant role in the fight against COVID. I guess what I'd really like to draw everybody's attention to is that COVID has really been an accelerator of Catalent's strategic plans and also an accelerator of the returns on our strategic investments. It's enabled us to put additional cash to work to continue to drive our long-term growth. I'll also note that it's increasingly clear that vaccines for COVID may be needed for years, including boosters and variants. And we're extremely well positioned to continue to be part of the solution. Our robust growth continued in the Q3, recording 35% net revenue growth and 44% organic adjusted EBITDA growth, primarily driven by the 113% growth in Biologics segment, which more than offset headwinds that we had in our SOT and OST. We raised our guidance, and the ranges were tightened with fiscal year 2021 revenue expected to be approximately 27% versus 25% previously, an adjusted EBITDA growth raised to approximately 33% versus 30% previously. We also have a strong balance sheet with our net leverage at 2.3 as of March 31st and $1 billion in cash, so we have a lot of firepower and flexibility should we need it for the right external target, and lastly, on your competitive positioning, the Catalent brand, the Catalent capabilities have never been stronger, and I think we obviously came into COVID with momentum. But with our strategic plans, we were building out capacity, and all of a sudden, that capacity became coveted assets. And so the dialogues that we were able to have with large strategic partners like Moderna, like Janssen, J&J, AstraZeneca were just absolutely incredible. Certainly, the need to move quickly was part of that. But the fact that we were a known entity, strong brand, great capabilities from an operations and quality standpoint, and then having the available capacity really put us in a terrific position. And then lastly, we didn't sit still during COVID just working on COVID-related items. I mean, we did an acquisition of MaSTherCell to get into the cell therapy area. We literally did the integration virtually, right? And then we also acquired Delphi Genetics. We acquired the Bone Therapeutics facility. We made massive CapEx expansions in non-COVID-related areas like spray drying in our Zydis Ultra. It's been an amazing year for the company. We're happy that the role that we've been able to play in the fight against COVID. Excellent. Thank you for the rundown there. To flip over to you, Tom, perhaps serendipitously for me, we've got you on your official first day in the CFO seat. You've been with the company for, I think, longer than a decade. Talk about what views you bring to the CFO seat and how you would expect to expand and progress. Yeah, Dave, thanks. Obviously, thrilled to be in the seat here and move into the CFO role. I've been with the company for 13 years, as you said, and seen the company come a long way under John's leadership. When I joined, we had $250 million of revenue, 21% EBITDA margins, and probably $150 million of cash on the balance sheet. Oh, and we were levered eight times. We are in a much different situation today as we sit here, coming off a record quarter, coming off, again, the ability to be able to raise guidance here in fiscal 2021. As John said, the strongest balance sheet we've ever had being levered 2.3 times and over $1 billion of cash today. Great to be able to step into the role here under these conditions. And as John said, Catalent's brand has never been stronger. In terms of the transition, this is not something that I think anyone is going to feel. I've been a member of the executive leadership team here for the last six years. I spent the last year and a half of my time embedded in the Biologics business as the BU CFO for that business, but also leading global operational finance for the entire company, and I look forward to getting back out and spending time with you and investors as well as we continue to execute on the strategic growth story for the company. Excellent. Look forward to that. Thank you and congratulations again. Thank you. John, you mentioned the brand awareness, the boost that Catalent got, and that was my next question of where I wanted to go. How has that changed the conversations that you're having with clients, elevated those conversations, and in, I'm sure, a broader sense than just, "What can you do for me on my COVID vaccine? You know, it's really a great question, and I will say that Catalent took full advantage of our capabilities and the situation to say, "Look, we have some coveted capacity. COVID will last however long it lasts, but we want to have a strategic partner. So if we're going to be partnering with you on COVID-related vaccines, we also want to have access to your future pipelines. We want to have more strategic conversations with you," and look, there's been a strong evolution, I'd say, since the time I've been in this seat from being purely tactical, speaking with the procurement department, to really having many more strategic conversations. I have relationships with many of the top pharma CEOs, certainly their supply chain SVPs and operations leaders, so that has progressed pretty significantly as, I would say, big pharma was looking to basically variabilize their costs. And emerging biotech was looking to have basically a virtual infrastructure. So that progress was being made. COVID was absolutely an accelerator of that. If I would tell you, I think where we are today is where I thought we'd be in four or five years in terms of the ability to have those strategic conversations. I just had a couple over the last month that I didn't think that that would be a conversation I'd be having with a high-level executive of a very large pharma company about how to partner with them in different ways. So certainly, I would say Catalent's ability to execute and perform, which has always kind of been the mainstay of the company, combined with our strategic plans that have only gotten better and better since our IPO. I've got a great board. They push us hard on the strategy. We've basically almost been in a continual strategic mode with our board. And that's the reason that we were able to have capacity expansions in place. And even when COVID was hitting, we were going to the board directly for additional capacity plans that we said, "Look, we'd be doing this otherwise, but we need it now." And they've been approving it. So again, Catalent's brand and capabilities have never been stronger. And I do think this also accrues to the CDMO industry at large. Because what happened through COVID, Dave, is that people realized that without the CDMO infrastructure and CRO infrastructure that we have here, we would not be sitting here now with basically three Emergency Use Authorization vaccines and the ability to scale them up. There are some of the vaccine providers where they have nearly a dozen drug substance providers for their vaccine, CDMOs, right? So I think if you were to go back to the big Pharma industry 20 years ago that was vertically integrated, I think they would be challenged to meet the needs of getting basically vaccines in under a year out to the population. So again, Catalent's brand and capabilities have never been stronger. But the industry also has never had more relevance, which I think is just going to continue to increase those outsourcing rates and the partnerships that you're talking about. Yeah. Yeah, so I want to key on your mention at the top of that answer about selling the coveted capacity, but leveraging that into the future pipelines. And your development revenue year to date is up about 85%. It's been really strong. I think an element of that is that these EUA vaccines are still kind of officially considered development because they haven't been fully, fully approved yet. And so it's a little difficult for us to fully understand how that longer-term, call it more normal pipeline is developing underneath your COVID activity that can support your long-term growth even after COVID's no longer growing. Can you peel the onion back for us a little bit on that? Yeah. So look, I mean, you have to start with the pipeline for drugs, both biologics and small molecules has never been bigger. It's never been stronger. That's point number one. Point number two, for companies like Catalent, you basically bring in molecules, do development, and some few actually get commercially approved. So the whole point is, if you're bringing in more molecules, if you're doing more development revenue, the likelihood of you securing that next commercial launch is pretty good, right? And I would also say that from a Catalent perspective, we look at the molecules we're bringing in and in what phase are they in. Certainly, we play at the earliest phases with a lot of the emerging biopharma companies, but we're also seeing a shift towards some later-phase assets coming to the company. And those later-phase assets, whether they're in phase II or phase III, ultimately have a higher potential, as you know, of going commercial. The other thing I'd point out with is from a Catalent perspective, we're never looking for the one big blockbuster, right? We love them when they hit. But the fact of the matter is that the company's strength has always been around our diversification, right? We're not dependent on any one molecule. We're not dependent on any one company. Certainly, we have those that have higher percentages of revenue in totality versus others. But the fact of the matter is that the diversification of the company has always been our strength. So look, we're going to continue to bring in molecules to the most robust drug development pipeline that we've ever had, which, by the way, the strongest part of it in terms of overall growth is in the area of biologics, which Catalent has really staked out a pretty big claim, if you will, for future biologics revenues and work with our customers. Sure, so let's pivot to cell and gene therapy. You've made a number of moves in the last several years, but including in the last year or so with MaSTherCell, as you highlighted. You've also, I think, added plasmid DNA, perhaps in part organically, maybe all organically. And so to back away from your actions, you've got competitors out there that are adding maybe a little bit more gene. You've got some other ones that are maybe more focused on cell therapy. Could you talk about the relative attraction? Where do you want to be? What moves are you making, and how are you making those decisions, buy versus build? So look, a lot there. I'll try to make it pretty concise. But we've been looking at the gene and cell therapy space for probably about four or five years from a strategic standpoint. And I'm incredibly happy about when we entered into the gene therapy area and also our very early entry, if you will, into cell therapy. And let me contrast the two a little bit. From a gene therapy standpoint, the fact of the matter is the de novo work that we did and it's playing out is that basically this is a technology and a therapeutic area that lends itself to CDMOs with outsourcing rates at about 65%. And we see if you're going to the 2026, 2027 timeframe, it would be we see it growing to 75%. It's just the nature of curative disease in the capacity that you need. And a lot of these companies are single molecule or very small pipelines. So it doesn't make sense for them to build out that capacity. When we bought Paragon, they basically had one suite up and running in their 2B commercial facility. Second one coming online. Catalent, what we do is we buy assets to scale them, right? So we were able to buy that asset. So we do an inorganic acquisition. We then supplement it with significant investments from a CapEx standpoint, now building out 10 suites now up and running there. There's going to be additional five that we've authorized with the potential for three more. And again, the pipeline is just fairly significant here. So we really see this continuing to drive a big part of the growth of the company. We've really been able to, again, scale that business in the very short period of time that we've had it since 2019. On the cell therapy front, we got in even earlier. I'd say we probably got in in the second inning or so, maybe third inning of cell therapy. If I were to fast forward 10 years from now, cell therapy is going to be a massive therapeutic category. It'll feel like personalized medicine. Again, we got in early. We're scaling up those assets, both in terms of commercial for the potential for allogeneic, as well as the work that we need to do for autologous, which we're doing in Houston and also in Gosselies. The way we'd look at cell therapy is, again, 10 years from now, it looks great. What we need to see is how it's going to progress in terms of autologous versus allogeneic. The allogeneic really lends itself for companies like Catalent because of our ability to scale and be able to do the manufacturing. If we stay in the autologous mode, if you will, there may be some other technologies that are going to be more bedside, closer to the patient, so we're going to have to watch that very carefully, so we're in the flow of those technologies, but I do believe allogeneic is going to be real because that's what will make it affordable, accessible for a lot more people, then the final point, what Catalent has done here with gene and cell therapy, we're also looking to be a much more vertically integrated supplier for our customers, adding our plasmid DNA capability, so actually, Dave, we've done it both organically and inorganically. Inorganically, we acquired Delphi Genetics and at the same time announced our organic investments that were actually well underway and in progress. We announced the two together to basically announce our entry into that plasmid DNA space. There's few big credible suppliers that are well known. A lot of the work, I'm sure, is going towards COVID right now. For gene and cell therapy companies, you need that feedstock. Catalent's ability to provide them their plasmid DNA and then scale them up through gene therapy or cell therapy is actually a big deal. So in the, I'll call it the white space of cell and gene therapy or the capability map of cell and gene therapy, have you covered them all now? Or are there other bolt-ons, other capabilities that you'd like to fill in from that vertical integration? I'll say that one of the things that Catalent's been doing now, again, as we've grown up, if you will, is we have a pretty substantial science and technology team who are always looking at what are those potential pipeline technologies or potential pipeline disruptors. And right now, I would say this space is moving three times as fast now as it was 10 years ago. So I think we're going to see as much change in the next five years as we saw over the last 10 or 20. So you've got to be in the flow of the science and technology. From a pure capability standpoint, I feel great about our overall capabilities from a viral vector standpoint, oncolytic virus standpoint, plasmid DNA standpoint, cell and gene therapy, both autologous and potential to do allogeneic. One area where we'd love to get some additional assets would be gene therapy assets in Western Europe, where we'll hunt around a little bit for those because today, very focused, obviously, in gene therapy out of the Baltimore area. If we could also get a little bit of a footprint in the gene therapy area in Europe, I think that would be attractive. But from an overall capability standpoint, we've got a good set of assets right now. And we're always looking very aggressively for those next capabilities or the potential disruptors, which you've got to watch out for. Sure. Let's move to capacity. So you mentioned the build-out of suites with Paragon and with your gene therapy capabilities, the CapEx commitments that you mentioned the board has made to continue to follow those up. So first question here is, is there basically an expected price to build out this capacity? Or is there a, let's call it a bells and whistles way to do it and a cheap way to do it? And does that matter to the client? So let me start with that one. First of all, there is a premium for the right capabilities. I had a strategic conversation with a customer two weeks ago talking about Bloomington. They love our technology in Bloomington because we have the highest level of technology, if you will, in terms of how we've designed out our suites, in terms of the grades, and also the technology we've used for under-isolators. From a drug product standpoint, we literally have kind of the top of the top, both in terms of the design of the facility and the rooms, as well as the actual technology that we have. Look, we always look at all of our CapEx in terms of what do the customers want? What is the cost of that? And what is the ultimate return? But I can tell you in the highest levels of drug manufacturing with sterile fill-finish, there's always going to be a premium for having those best assets, if you will. We've got a great partner from a machine capability standpoint in Optima that we've used. We have other terrific partners. And the other thing that's kind of interesting, Dave, I spend a lot of time with customers. I also spend a lot of time with suppliers. I won't name all the names, but I will just say all the key suppliers for biologics work, whether it's on the equipment side, whether it's on the consumable side, whether it be on the single-use side. I have relationships literally with every one of those CEOs, as well as my COO, Alessandro, as well as our engineering team that we built out pretty substantially. You can imagine a company that was spending $150 million of CapEx circa 2014 IPO to spending somewhere between $650 and $700 million of CapEx now. We've had to significantly plus up our overall engineering team and capabilities. We've got great folks in place. But putting the right asset in place pays. It just pays. And I think Catalent's done a great job with our external engineering firms and construction firms in terms of making sure that we have assets that are going to be long-lived over a 10 to 15-year period and that our customers absolutely want. Excellent. So the related question I had on that capacity is in kind of speeding the installation of the high-speed filling line and being able to kind of learning how to do that in a hurry, has the last year compressed permanently the timelines that you can put capacity in place? Can you get it in place faster? Here's what I would tell you. Certainly, we've learned that we can go faster. Case in point. However, there is a premium when you're recruiting contractors from outside a five-state area in terms of working 24/7, all the overtime that's entailed with that, and certainly, that's added to the overall cost, but there are some things that we've learned in terms of how we can go faster, how we can use our external partners to partner even more. I would say Catalent's always been fairly good at this, but we have learned how to go a little bit faster, but there are certain cost escalators that I don't think we want to repeat if we don't have to, and also, with speed, sometimes comes challenges, right? None of these projects are perfect. But the faster you go, it's harder to measure twice and cut once, if you know what I mean. My grandma from Northern Ireland always reminded me of that. And we didn't have that luxury at all points here. But we've learned how to go faster, but we don't need to also endure the expense of these compressed timelines if we don't have to. Understood. I'm going to sneak one quick one in on long-term guidance. You've made some significant progress against your long-term guidance. It's kind of targeted to 2024. How do you think about progress toward that and updates of that, given what seems to be accelerated progress against your targets? First of all, we've made tremendous progress against those targets. If you recall, Dave, I presented it back at a healthcare conference back in 2019. And when we presented those targets of $4.5 billion of revenue, 28% margins with half of our revenues coming from biologics, I think there was enthusiasm, and there may have been some skepticism. How are you actually going to get there? And then I was able to update in the following healthcare conference, one year later, that we've made progress against those goals. And we no longer needed any substantial M&A to get to the revenue goal. And then you saw in our most recent quarter, we clocked 52%, obviously driven by the COVID tailwinds, if you will, 52% of revenues coming from biologics. So look, when you have high biologics as part of your overall mix, where you know that you're going to be operating in the 30%-35% margin, it's only going to do very positive things to your overall margin mix. So look, we feel really great about the progress that we've made against that 2024 goal. We're going to continue to see, I'm sure, acceleration from clear that vaccines are not going to be one and done. There's going to be an ongoing need. We actually have demand out through that we've announced that's going to be out through our fiscal year 2023. We've had customers announcing out demand through 2023. So I think you put that all together, and I think it just says that those goals are we've made great progress. They're achievable, and we think we can also meet those goals. Excellent. Appreciate that. I've kind of run over, my fault. Thanks for the time, and good luck with the rest of your meetings today. Hope you enjoy those and appreciate the audience's attention. We'll let you go. Thanks, Dave. Have a great day. See you. Thank you. Bye-bye. Thank you.