Okay, great. Welcome, everyone. I'm Puneet Souda, a SVB Leerink t ools and diagnostics analyst here. It's my pleasure to be hosting the Catalent Management Team today. Joining us from Catalent, Wetteny Joseph, CFO, and Paul Surdez, IR. Great to have you guys here. Wonderful that you can join at the 10th Annual SVB Leerink Conference. Thank you very much, Puneet. Very pleased to be with you this morning to share Catalent's story. Great, great. So, Wetteny, I believe for the first part of the session, you have a few slides, and then we can jump into Q&A after that. Exactly. So with that, then. Yeah, I'll take it away. Again, thank you for having us. Before I dive into the presentation itself, let me just first draw your attention to our forward-looking statements and also our non-GAAP financials. I also encourage you to review our SEC filings to understand the risks and uncertainties that may bear on our operating results and financial condition. Catalent, for decades, has been the leading global provider of advanced delivery technologies and drug development and manufacturing solutions. As a leading CDMO, we continue to differentiate ourselves through innovating drug delivery technologies and manufacturing capability and capacity for small molecules, biologics, cell and gene therapies, as well as vaccines and other novel modalities. This slide describes just the depth and breadth of our capabilities and scale that enable us to power the biotech, pharma, and consumer health customers across the drug development cycle, all the way from preclinical through commercial manufacturing and across a wide range of modalities and therapeutic categories. We have 1,200 active drug development programs, which yielded more than 160 product launches for us last year. And every year, we reliably supply well over 70 billion doses across 7,000 products, or roughly one in every 20 doses that are taken globally. At Catalent, our DNA is all about working with customers on the largest, most complex challenges to find solutions for their problems. When the pandemic was upon us last year, we were really well positioned from a capability perspective, as well as from a capacity perspective, to become a go-to company for COVID programs and vaccines. To date, we've signed more than 80 compounds with our customers across our segments and are positioned to deliver billions of doses over the next couple of years with our customers in response to this pandemic. Again, a testament of our capability and our ability to scale and deliver for our customers in a time of need. When you look at Catalent, diversification has been a historical area of strength for us. No matter how you segment our revenues, we don't have any significant concentration of risk. If you look at geography, roughly 43% of our revenues come from outside the U.S., and this is roughly aligned with the Western biopharma industry. From a product type perspective, we're diversified across branded, biologics, generics, OTC, and VMS products. If you look at products individually, there's no single product that drives our business. We manufacture over 7,000 products, with the largest contributing less than 3% of our revenues, while the top 20 only make up 18%, including the top product that's less than 3%. Our revenue streams are also very diverse. With 56% of our 2020 revenues tied to commercial manufacturing, about a third are recognized in high-value development solutions for our customers, which, by the way, is also a pipeline to our commercial manufacturing. And the remainder with our clinical supply services. With more than 1,000 current customers, our customer base is also very broad, partnering with nearly all the top pharmaceutical companies, biotech, generic companies, and consumer health companies as well. Catalent is really a leading player in a large, vibrant industry. We estimate the total spending by biopharma companies in the broad markets which we participate to be roughly about $160 billion of spend. Approximately $60 billion of that is outsourced to CDMOs, which represents about a 37% outsourcing rate. Now, there are several industry trends that are driving increased outsourcing and the growth of the CDMO industry. First, small-cap biotech companies have clearly become the innovation engine for big pharma. And these companies rely heavily on CDMOs as development partners and for manufacturing capacity. Next, the market is shifting to more complex modalities that are outsourced at much higher rates. For example, if you take cell and gene therapy, we estimate the outsourced rate is approximately two-thirds, with demand far exceeding current and anticipated future supply. And finally, the R&D pipeline is robust and growing, primarily driven by biologics, which is growing double digits as well. This slide really shows the strong position that we have across our end market segments and how each of our business units plays a specific role within the Catalent portfolio. The biologic segment, which includes our drug substance, drug product, cell, and gene therapy offerings, has become our largest business segment, as well as the fastest growing. Softgel Technologies has been the foundation of our stable base of long-cycle businesses, with the bulk of the 7,000 commercial products we produce. We've been a market leader in softgels for more than 80 years, and this segment provides stable cash flows that allow us to invest in the faster-growing, higher-margin businesses. The oral and alternate delivery segment provides advanced formulation development and manufacturing across a range of technologies, including all technologies such as proprietary Zydis orally disintegrating tablets, as well as inhaled pill forms. Oral and specialties currently are the highest-margin segment and have a robust pipeline of approximately 200 molecules. Finally, our clinical supply and services segment provides manufacturing, packaging, storage, distribution, and inventory management for drugs and biologics in clinical trials. These are shorter-cycle services that touch the highest number of customers and offer substantial synergies for their development pipelines. One of the most important highlights for Catalent is that we have fundamentally transformed the company through significant organic and inorganic investments, totaling approximately $4 billion over the last five years. These investments have given us access to a greater share of the R&D pipeline, an earlier entry into the Follow the molecule suite of services, and greater exposure to biologics, which is the fastest-growing part of the industry. When we launched IPO back in 2014, about 10% of our total revenues were tied to biologics. Over the last five years, we've made several significant biologics, cell, and gene therapy acquisitions to complement our organic investments, both yielding robust growth last year. In the 12-month period ending this past December, our biologic segment represented 40% of our portfolio, compared to roughly a quarter of our revenues just a year ago. We expect our biologic segment to continue to grow significantly faster than the rest of the company and represent approximately 50% of our revenues, maybe even earlier than the 2024 timeframe that we have as a target. Before I move on to questions, I would like to highlight our overall strong financial performance when you look at over the last few years, which include 12% organic CAGR on revenue and 17% CAGR for our Adjusted EBITDA. Our guidance for fiscal 2021 projects accelerated growth above these levels, including net revenue growth in a range of 23%-28%, with all but two percentage points of that being organic. With that, I'll be happy to take any questions. That's great, Wetteny. So thanks for the presentation. So first one, maybe just let me start on the recent drivers of your guide raise. Maybe just walk us through that for the fiscal year ending June 30th, the guide that you raised. Maybe just walk us through a couple of things that you're seeing in the market, and that gives you more confidence. Sure. Look, first of all, we're very pleased to have kicked off the year with really solid growth, robust organic growth, certainly that positions us well to be able to deliver not only what we initially guided to at the start of the year, but even more as well. Our visibility only increases as we get further into the year. And if you look in particular, not only is the non-COVID, I'll call it base business, growing well for us, but the COVID programs, as certain programs get authorized for emergency use, for example, start to drive even greater line of sight for us. And while throughout the year, we've been very consistent in that we only include the take-or-pay for the larger volume COVID programs in our guidance, but also any orders that our customers place with us clearly are included in our guidance. Over time, those have increased, which affords us even more opportunity to deliver more on the given year. The increase in our guidance was roughly about seven points. If you look at the midpoint from a revenue perspective, this was the second increase that we've had since we started the year. And that said, those seven points, I would say about five are driven by the net contributions from the COVID programs, leaving about two points from the rest of the business. So we continue to see not only a strong start to the year, but continued growth in the business on a non-COVID perspective. We're very pleased with that. Great. And in terms of the overall capacity, can you provide a sense of what are you doing to address sort of the tight capacity in the biologics offering? And maybe just overall, in the post-COVID world, is it fairly easy to transition from COVID to non-COVID work? Sure. Look, when you look across our biologics offering, it spans cell line development, where we can take DNA and actually select the optimal cells that can really grow in bioreactors to then manufacture the drug substance, right? And we have drug substance manufacturing, drug products that will finish across a number of formats, whether it's vials, syringes, we can lyophilize, and then, of course, we have gene therapy via viral vector manufacturing, which actually has applications not only for gene therapy, but also for vaccines, and then cell therapy as well in bioanalytical services, so we have a number of different offerings within the business, where we've been expanding our capacity to match the capability and the pipeline that we have and the growth that we've been experiencing. We expect to continue to experience in the business. And so as a result of that, we committed expansions in the business that happened to coincide with a pandemic, where the demand is for the same capacity and capability that we have. And that's creating a little bit of a pinch point, I would say, particularly for vial capacity, right, in terms of our vial lines. And really, for a short period of time, we anticipate over the next couple of months, additional capacity coming on stream that will relieve some of that tightness if you're all involved. But the reason that I step back and look at the broader spectrum here across the segment is to really highlight the fact that our capacity and capability is not solely in vials. We certainly have a number of other avenues where we deliver services and formats that we deliver, even from a drug product perspective, to our customers, where we continue to have a strong runway and capacity to continue to grow for our customers, and we have a number of places across the network where we are expanding currently, particularly with vial capacity, both in North America and in Europe, that will continue to address the demands for our customers. Now, from a post-COVID standpoint, my belief in terms of how we look at the business is we're on a strategic pathway. The strategic pathway continues to capitalize on the faster-growing biologics segment, and we've attracted, via our capabilities, a number of development programs to our customers, and the broad pipeline continues to grow rapidly, double the pace of small molecule growth. And so with that, what the COVID-19 programs have done is they have accelerated the use of some of those assets. And to some extent, we've accelerated the deployment of some of the capital, where we'll get a very attractive return for those. But in the end, we're in a better place in that strategic trajectory with the acceleration than we would be without it. So I feel great about the acceleration of capacity in this space that will be utilized in a market segment where we're, I would say, a quality player with an attractive pipeline. And none of these assets are specifically unique to vaccine production. They are the same assets that we had acquired or had in flight that are being used for, in some cases, for vaccine production and very fungible in terms of using them for other biotherapeutic uses, et cetera. To give an example, with respect to viral vector manufacturing, where we have a number of gene therapy programs that we're working with customers have deployed capital to expand in that business, we're now using some of that capacity for virus production in terms of the drug substance, including the same assets that we would use for others as well. Again, very well positioned in terms of what this means for the future and just where we would anticipate being from a strategic perspective anyway. Got it. No, that's very helpful. And talking about viral vectors, I mean, when you look at the supply-demand dynamics of that market overall, the demand-wise, maybe just give us a sense of where that sits? What are you seeing today and where that could be in the next couple of years? Because obviously, throughout the last year, we saw a number of capital raises across these small to mid-cap companies in gene therapy and across the board in biotech. So again, they have capital to put to work in R&D and whatnot. So we'd love to get your views there. Look, that end of the market continues to be very robust. We continue to see new entrants into the pipeline, into the clinic. There are approximately 600 gene therapy assets that are pursuing roughly 1,600 disease states. And if you look at the broad market, there's a lot more to go, right? It's estimated somewhere in the 6,000 range in terms of different disease states that can be pursued via gene editing and so on from a therapeutic category standpoint. So lots more space and customers in this segment are seeing an increased funding environment and continue to bring in new assets into the pipeline that's continuing to drive the supply and demand dynamic that we see, even factoring all the capacity that's installed, plus in flight and announced. We continue to see over the next five to six years a supply and demand imbalance where there's not enough supply for the demand. Again, given what I've just said, existing assets plus new assets that you can anticipate coming on in the future. So we continue to see robust demand. And we believe even without significant commercial launches, we'll continue to see demand just to fulfill the development needs as more and more patients are being induced in this area. Got it. That's very helpful. And on that point, if I could, you made an acquisition this week, Delphi, in terms of plasmids. Maybe just walk us through what does that acquisition mean and what capabilities it brings to you. And obviously, you've been right around this time of the year. Last year, I think it was MaSTherCell that you had acquired. So obviously, you continue to execute well here. But we'd love to know what sort of capabilities that this brings and what are some other areas of focus for you. Sure. Look, about two years ago, we made our first entry into this area with our Paragon acquisition principally for gene therapies. As I said, we're using those assets for some other uses as well, which is great. But that gave us a platform, a platform from which we could launch a number of other offerings and services to meet demands for our customers. And we've been intentional about plasmids being one of those areas that we were interested to get into more. It's a key, I would say, reagent that's used not only for gene therapies, for gene-enabled cell therapies and other modalities have used for plasmid DNA as well. And so we see continued strong demand in this plasmid DNA area for the reasons I just said. This is one that, again, there's a real imbalance from a supply and demand perspective, where the demand is far outstripping the existing supply out there. Our customers certainly, we believe, value the opportunity to work with us across the spectrum of the plasmid DNA as well as the gene therapy on through the gene therapy manufacturing for the viral vector itself. So we see this as synergistic in terms of being able to do that work for our customers in a sort of a holistic and end-to-end type of a way and a vertical integration type of way. And it's happened to coincide not only our intentional organic investment in this area, which we announced at the same time as the Delphi acquisition, but the actionability of Delphi, which clearly, when we make acquisitions, we tend to have assets that we've been really engaged in discussions with and getting to know them over an extended period of time. It just so happens we can't really control when they become actionable. But in this case, became actionable right in time with and complementary to the work we're doing on the U.S. side with respect to an organic play. We now have a player with key strengths and capability across that spectrum from a development standpoint all the way through GMP commercial manufacturing for plasmid DNA and a very capable and agile team that can meet the demands and complexities around that, again, whether it's being used for gene therapies or gene-enabled cell therapies or some of the other modalities that might use plasmid DNA as well, so we're pleased to be able to bring them on to the Catalent fold, and it continues to just build up this platform that we started two years ago and complementary to the other moves we've made. And talking about cell therapy, there are a number of workflows that are proprietary there. So maybe just give us a view as to how much of that business can actually transition over into the CDMO world. Maybe how do you see Catalent's positioning there in cell therapy longer term? Look, I mentioned the number of assets that are in the gene therapy side, right? 600 assets with 1,600 disease states with 6,000 disease states to go after. I think when you look at the pipeline and potential cell therapy, it's similar to gene therapy, maybe arguably even more. And so we have the assets that we believe have the core capabilities. Again, just use agile and deeply technical team that we brought on with MaSTherCell and continue to invest in scaling that business with extensions in the U.S., as well as additions that we've made since that acquisition to continue to build out. When you look at the ability to work across autologous and allogeneic, CAR Ts, et cetera, I would put the team that we have in cell therapy up against anyone in terms of just the depth and breadth of their capabilities and ability to attract some of the premier, I would say, companies that are pursuing these disease states from a cell therapy perspective. From a capability perspective, I do feel that we have a really robust set of offerings there. We believe in our hands, these assets are even better able to scale towards commercial and larger volumes with customers, particularly when you think about on the allogeneic side, we can benefit from the scaling as well as some of the regulatory pathway to get products commercialized and so on. You can see the parallel in gene therapies, right, where we bought the Paragon business, as I said, almost two years ago, and since then, coupled with Catalent, their pipeline, their capabilities, et cetera, coming into Catalent, along with our track record of going through regulatory processes, et cetera, we are now the only CDMO with an FDA commercial license to produce gene therapies, so you can see how that combination works. Again, the track record we have and the scale that we have delivering 70 billion doses a year and other commercial products and the number of launches we do every year, that's a well-exercised muscle, I would say, across Catalent that we're applying in these areas of gene and cell therapy as well. So looking at a number of these growth areas, how should we think about capital deployment? Maybe just give a sense of how you're prioritizing internal versus external investments and especially M&A. And more importantly, how long do you think the CapEx could continue to remain elevated here? Look, it all starts with a clear strategy. And we really take an in-depth look at the market every year. And it rolls right into a strategic plan exercise that we do. It's almost a continuous sort of strategic view. And as we do that, we have line of sight into what the demand profile looks like for existing programs that we're working on that are advancing. As they go from early to mid-phase and then mid to late phase, they require more and more volume. And then as programs get commercialized, so we have a really good view in terms of what the capacity needs are on an ongoing basis. And then, of course, there's a broader market growth as well. Given our position, we want to be able to attract at least our fair share, if not more, of that growth in terms of new pipeline or late-phase programs that need a commercial home. We want to make sure that we bring them into the Catalent fold as well. Looking at all that, we now then say, do we build it organically, which is typically we have a bias towards organic growth, right, organic capital deployment. There are opportunities where if we have an existing pipeline that requires commercial scale sooner rather than later, having that line of sight and finding the right asset at the right valuation to accelerate that is potentially an attractive option versus organic deployment. We will do so. So given the platform ads that we've done over the last X number of years, we now have the opportunity to deploy capital organically. And you see us doing that at record levels right now. And we would anticipate over the next two years continuing at that level if you look at it from a percentage of revenue standpoint as we scale those businesses. But you've also seen us make a number of moves where we are buying assets that have the capacity where we have a high level of confidence given our existing pipeline that we can utilize those assets in an accelerated fashion versus a two- to three-year build. And so we'll continue to look at that build versus buy type of equation given what we have in our hands from a pipeline perspective and the growth that we can anticipate from that where we see an opportunity to accelerate that. We'll do an inorganic move if it's actionable. Got it, and then last one on in terms of profitability, long-term outlook for EBITDA margins, how should we view that in context of the biologics business and more growth that you're seeing with cell and gene therapy here? Yeah. Look, the overall Catalent margin expansion picture we've laid out in terms of expanding, largely driven by a higher proportion of our revenues coming from biologics, and as we scale those businesses as well. I described earlier a number of places where we're expanding the business. As As we do that, it won't be linear as we add on capacity, add on resources to run the capacity, and then as we ramp up the utilization of that capacity, you'll see the margin picture really crystallize, and you've seen that happen in the business already, and so as that becomes a higher percentage, we see the overall Catalent margins expanding with a target that we put out there of 28% for 2024, and you can see how we're going from a revenue coming from biologics increasing, and you'll see that play out. Again, it won't be linear, but we certainly have a line of sight into that. So we do believe biologics can sustain EBITDA margins in the 30s. And as that happens, that elevates the overall Catalent picture. And we'll continue to execute on that as we scale the businesses as well. Got it. Very helpful. This was great, Wetteny. Thanks again for the time. This is always wonderful to have you and Paul at our conference. So thanks for taking the time today. Thank you very much for having us, Wetteny. It's our pleasure. Thank you. Bye. you. Bye.