Everyone, we're going to get started now. Our next session is Catalent. Thank you all for joining us. I'm John Kreger, the analyst at Blair that follows Catalent. I do need to remind you that if anyone wants to see our disclosures, please see williamblair.com. What we're going to do from a logistics standpoint is we'll be here in this room for the next 30 minutes. Tom Castellano, the CFO, is our speaker. He will probably not have a full 30 minutes of remarks, so we'll have a few minutes of Q&A time here, and then we will go up to the Maher Room on the second floor for the breakout session. So Tom, thank you very much for joining us. I'll hand it over to you. Great. We can start with the next slide. Okay. So maybe just my background: Tom Castellano, CFO of the company. I've been with Catalent for over 13 years, but only been in the CFO seat for the last year. I was previously in many different finance roles across the organization, including investor relations when we went public in 2014. Obviously, very proud and humbled to be here today to represent Catalent and share with you some of the highlights of our growth story, as well as some of the improvements we've made from an ESG perspective, which we thought was relevant to highlight here to the team. We can go to the next two pages. Just as John mentioned, from a disclosure standpoint, I just want to draw your attention to both forward-looking statements on this page, as well as the non-GAAP financial measures on the next page. I'd also encourage all of you to read through our SEC filings to further understand any of the risks and uncertainties that bear on our operating results, as well as our financial condition. Next page, please. Catalent is a purpose-driven services company, and our mission is to help people live, quite simply, better, healthier lives. We do this by partnering with biopharma companies, cell and gene companies, consumer health companies, to really optimize, develop, launch, and supply patient treatments across multiple modalities within the Catalent network. We are currently an S&P 500 company. We were added to the index about two years ago. We operate 50 sites globally across four business units: our Biologics segment, which is our largest, our SOT segment, or Softgel and Oral Technologies, our Oral and Specialty Delivery segment, and our Clinical Supply Services segment. We have over 19,000 employees across the globe, and 2,500 of those employees represent scientists and technicians. Moving to the next page, this slide really illustrates the depth and breadth of the capabilities and scale that Catalent has that really enables us to power biotech, pharma, and consumer health companies across the drug development cycle. We're working with everything from preclinical all the way through commercial manufacturing across a wide range of modalities and therapeutic categories. On the right side of the page, you see we currently have about 1,400 active drug development programs, and we launch somewhere between 150 and 200 new products each year, commercially approved products on behalf of our customers through that pipeline of more than 1,400 products that we have in development. If you look at things over the last 10 years, Catalent is proud to say that we have successfully assisted in nearly 50% of all FDA approvals to some extent. And from a commercial manufacturing standpoint, we've reliably supplied well over 70 billion doses across 7,000 products, touching 1,000 customers each year, and that's roughly one in every 24 doses that's taken globally, which impacts the lives of hundreds of millions of people each year across the globe. Moving to the next page, this is one of my favorite pages in the deck. I want to talk through some of the diversity, which is really a historical strength of the company, and it's highlighted on this page. You can see that regardless of how you segment our revenues, that we have limited concentrations of risk. I think if you look at things from a geographic standpoint, we have about 60% of our revenue today that comes from the U.S., 40% of it outside the U.S., with about 35% coming from the European continent, and I would say this is very closely aligned to the industry overall. If you look at things from a product type standpoint, we are extremely diversified across branded drugs, biologics, generics, and over-the-counter VMS products, and we've recently further diversified our portfolio by going deeper into the consumer health space with the $1 billion acquisition of our Bettera business, which got us into gummies, soft chews, and lozenges, which has been a really attractive market for us here in the U.S., which we'll talk about a little bit later. From a product standpoint, of the nearly 7,000 products that we make, we don't have any significant concentration. Our top 20 accounts for just about 38% of our overall revenue, and all other products, the rest of the 7,000 accounts for that remaining 60-plus%. Our largest product is about 8% of sales as of last year. I expect that number to maybe be a bit higher. We should have a 10% customer in the current fiscal year, and we did disclose that that was trending in our last 10-Q. And from an activity standpoint here, our revenue streams are extremely diverse, with commercial manufacturing being the bulk of our revenue, which shows 45% and 45% here between commercial and development. But if you normalize for the COVID-related revenue, which is mostly treated in that development bucket given the emergency use authorization and not fully commercially approved, that number would be more like 60%-40% in terms of 60% of our revenue being commercial, 40% or so being development. And then I would say just lastly on this page, with more than 1,000 customers that we have, our customer base is clearly very diverse as well. You can see from the top section of the page, we're really working with everyone across pharmaceuticals, big pharma companies, biotechs, generic companies, and consumer health companies as well. Moving to the next page here, you can see on this page that we operate in an extremely attractive end market. Catalent is the leading player in a large and growing industry. We estimate that the total spend from our customers around this industry is approximately $165 billion. That was based off of our fiscal 2021 year, with approximately 40% of that, or $65 billion, being outsourced to CDMOs such as Catalent. And that outsourcing rate does continue to increase. It was about two to three percentage points lower two years ago than where it is today. You can see that Catalent stands here at about $4 to $5 billion of revenue, so a very small portion of that overall outsourced demand goes to us, and we see significant growth opportunities that exist as a result of that. There's clearly significant industry trends that have driven the increased outsourcing and long-term growth that we've seen across the CDMO industry. I would say the complexity of molecules in development is one of those factors. We're seeing more and more pharma and biotech companies looking for an outsourced provider, given the complexity of molecules being developed. The significant increase in the number of modalities, which we'll talk about on the next page, is certainly another reason. I would say that the small-cap emerging biotechs really look at things from an innovative engine perspective from big pharma, but lack that manufacturing horsepower and are looking for a partner such as Catalent to help navigate that part of the market for them. Finally, I would say the R&D pipeline is extremely robust here. As we see on this page, it's growing about 10% annually. That's primarily driven by biologics, which is growing double digits and is expected to drive more than half of future pharma growth over the next couple of years. I would say our strong performance and strategic investments that we've made over the last couple of years have really well positioned us to capitalize on these favorable market trends. In addition, the role that we've played through the pandemic has really caused some of the drivers to become even more pronounced and creating higher demand and raising the profile for Catalent and the CDMO industry overall, and to put it in perspective, Catalent was in a position to be able to supply over 2 billion doses of COVID vaccine to the market over the last 18 months. Moving to the next page here, as we look at the future, I mentioned the shift around modalities. As we look to the future here, we think it's also informative to look at the past, and it's hard to believe that just about 15 years ago, there were still only a handful of modalities out there in the market to address various different disease states, and today, the industry is obviously meaningfully more broad and complex as well. We believe that five years from now, we will see a total transformation of the industry with the number of modalities and, importantly, the complexity of those modalities increasing, which plays well to the strength and the portfolio of assets that Catalent has built over the last five or so years, including entry into gene therapy, cell therapy, mRNA, iPSCs, and more recently into plasmid DNA manufacturing. Moving to the next page, this slide illustrates the strong position that we have across our key end market segments and how we go to market with our customers. Each piece of the puzzle for Catalent plays a very specific role in the portfolio. I'll start with our Biologics segment. This is our largest segment here, representing about 53% of our revenue overall. Here, we do drug product manufacturing, drug substance manufacturing. We have cell and gene therapy offerings, as well as plasmid DNA, as I mentioned, and it's become our largest segment, growing the fastest at a 10%-15% long-term growth outlook at the highest margins that we have within the company at 31%, looking at this from an LTM perspective. This is the business that does drive the most opportunity for further margin expansion that we have a company with a long-term target, which I'll get to later, out there of 30% consolidated EBITDA margins across Catalent by the fiscal 2026 year. Our next segment that I discuss is the softgel oral technology segment. This has been the foundation of our stable base of long-cycle businesses, and where we make the bulk of our nearly 7,000 commercial-approved products come through our softgel and oral technologies business. We're the inventor of the softgel for more than 80 years ago, and this segment is a significant cash flow generator for us, and it allows us to invest in more fast-growing, high-margin businesses like the gummy Bettera business that I highlighted earlier, but also our biologics business, which I talked about is a beneficiary of some of the significant free cash flow that this business has generated. As a result of that Battera acquisition, we were in a position to change the long-term growth outlook of this business, which historically, I would say, was a low to mid-single-digit grower to now expectations of 6%-8% for our SOT. Our oral and specialty delivery business, which makes up about 14% of the company's revenue, provides advanced formulation, development, and manufacturing across a wide range of technologies, including our proprietary Zydis orally disintegrating tablets, as well as several inhaled dose forms that we have. This business has, I would say, more early-stage development revenue than it does commercial revenue, but it has an extremely robust pipeline that today consists of more than 200 molecules. And then last but not least, I'd highlight our clinical supply services segment, where we provide logistical support for clinical trials on behalf of our customers that crosses over to manufacturing, packaging, storage, distribution, and inventory management services for biologics and small molecule drugs across clinical trials. This is a short-cycle business for us that touches the highest number of customers and offers significant cross-selling opportunities with the other segments that we have in the portfolio. This business grows at about 6%-8% that I would say at EBITDA margins that are very closely aligned with the consolidated Catalent. Moving to the next page, I want to talk a little bit about the strategic deployment of capital that we've made over the last five years. We've made transformative investments that have shifted our technology portfolio to more innovative and more in-demand areas of drug development and manufacturing. This chart represents going back to fiscal 2016 for us. We've deployed approximately $6 billion, with more than $4 billion of that tied to acquisitions, where we've seen significant returns and have created a platform for follow-on high ROIC Organic Investment. So Catalent has run the play of adding technologies to the portfolio through M&A and then invest organically to scale those up. Some of the notable acquisitions we see on this page include our Bloomington, Indiana facility, which was the Cook Pharmica acquisition, the facility we added in Anagni, Italy, from Bristol Myers Squibb. Both of those facilities were the beneficiary of significant COVID-related demand and gave us the capability and capacity to play the role that we did through the pandemic for our customers. We have also added cell and gene therapy assets through the acquisitions of Paragon and MaSTherCell, seen on this page here, as well as other adjacent areas, including plasmids, and as I mentioned earlier, the Bettera acquisition, which you also hear, which was our entry point into the gummy-based nutraceutical sector. Over that same period of time, though, from 2016, we also deployed about $2 billion worth of CapEx investments. You can see the list here as some of those organic investments. CapEx has been extremely overweighted over the last few years for its buildouts in biotherapeutics and cell and gene therapy to really help meet the patient and customer demand and have substantially added long-term value creation for the company. On the next page, you'll see how we've been able to achieve some of the growth through these investments through an extremely efficient capital structure. We're currently levered at 2.6 times, which is right at a historical low for the company. That's below our long-term target of 3.0 times. We do have the ability from time to time to increase our leverage, and we've shown that over the last several years with some of the acquisitions for the right strategic acquisitions, but need to make sure that corresponds with a very aggressive deleveraging profile. The business naturally delivers somewhere between a half a turn and a full turn per year just based through EBITDA growth alone, and we've really maintained some very strong discipline about deleveraging when we have taken our leverage profile up to the levels above that three-times long-term outlook. We have about $900 million or so of cash available on the balance sheet, so with the ability to tweak leverage as well as utilize cash we have on hand, we have significant firepower to continue to be active on the M&A front, and again, that's a lever we've consistently used through the years to create value. In looking at our debt stack, we have no significant maturities until 2027. We spent a lot of time making sure that we're well insulated from any potential increases in interest rates. We have about 80%, approximately 80% of our debt that is on a fixed-rate basis, so not subject to any of those interest rate fluctuations. And ongoing, our capital allocation priorities will be focused on organic investment first and foremost, but M&A as well, and we'll look for proactive opportunities to either further pay down debt or look at potential share buybacks in the event we find ourselves in an excess cash position here without any further investments necessary on the organic or inorganic front. Moving to the next page here. This is just a quick update on our strong financial performance. As you look at the revenue growth of the company as well as the EBITDA growth of the company over our last three fiscal years, the purple bar represents our LTM revenue and EBITDA as of our third quarter, which we just released last month. You'll see a CAGR of 17.5% revenue growth, 22.8% EBITDA growth, significant margin expansion we've been able to realize over this period as well, and see the company growing at rates that have been consistently in excess of the long-term growth outlook that we have of 8%-10% from a revenue perspective. Now, there are some acquisitions in these numbers. If you were to strip out the acquisitions and look at this truly on an organic basis, we would still be showing double-digit growth rates well in excess of the 8%-10% long-term organic growth that we have for the company. Moving to the next page. So here, I wanted to highlight a little bit of the evolution of our long-term growth outlook. In January of 2020, right before the COVID pandemic really kicked off, we went out with a long-term target at the J.P. Morgan Healthcare Conference, talking about $4.5 billion of revenue as being the goal for the company by fiscal 2024, an EBITDA margin of 28%, and shifting our portfolio more towards biologics, which at the time was about 25%-30% of our revenue, towards 50%, and we stand here today in our fiscal 2022 year, two years ahead of schedule, and have already achieved in excess of $4.5 billion of revenue as a consolidated company and see our biologics business, as I mentioned earlier, at about 52% of the total revenue and remain on track from a 28% EBITDA margin by 2024, so this past January, we did increase our long-term target. Our long-term target you see on this page now by fiscal 2026 is greater than $7.5 billion of revenue for the consolidated company at EBITDA margins of approximately 30%, and we have aligned to those growth rates without any meaningful contribution of COVID-related revenue being necessary in those outer years to be able to drive towards that $7.5 billion of revenue. That was an important point for us to make on our last earnings call to clear any uncertainty around assumptions related to COVID in terms of it being necessary to achieve the $7.5 billion of revenue for the company. Lastly, on the left side of the page here, you can see that we're extremely comfortable with a consolidated long-term organic growth rate for the company of 8%-10%. We mentioned on our last earnings call that we have guided to growth rates next year, which starts on July 1st for us, our fiscal year, of 8%-10% with a significant de-risking of COVID-related revenue next year. So having guided to a normal growth rate with COVID being a much smaller contributor for us next year, given the phase of the pandemic moving to endemic and what that means from a volume perspective. I think the reasons why we have comfort around that is we've brought on significant assets or capacity over the last couple of years with recent organic investments across the company that will start to ramp in terms of utilization, mostly across our biologics segment next year. We also see significant organic growth around current assets that we have, including an uptick in commercial demand within our SOT business. That's partly attributable to the acquisition of Bettera, which will be organic for us for nine out of the 12 months in our next fiscal year. We're also seeing a shift from some of our fungible biologics assets that we brought online during the COVID pandemic that have been dedicated to COVID capacity to other customer products, including some recently signed large commercial tech transfer programs that the company has been able to win and onboard and will be in the process of doing that over the next couple of quarters. My last page here on the next slide, I just wanted to end with a little bit of our progress on the ESG front, something the company obviously takes extremely seriously and is extremely proud of the progress we've made in a very short tenure as a public company. When you take a look at carbon emissions, diversity and inclusion, as well as community investments, we're in a position to continue to shape our sustainability focus that's really in line with our core business strategy, aligned with the business strategy of our customers as well. We did publish a third annual corporate responsibility report in March that covers the progress that we made and continue to make in 2021. And I'd like to encourage anybody interested in learning more about the company's commitments as well as our past achievements. You can download that report off of our investor relations website. So that concludes any of the comments I wanted to make, John. And in the last five minutes, maybe I'll turn it over to for any questions before the breakout session. Great. Thanks. Yeah, we've got five minutes. I'll start with one, and then please feel free to jump in anyone else that has one. So Tom, the capital markets have obviously changed a lot in the last six to nine months. As you think about your development pipeline and the kind of conversations you're having with your sort of earlier stage project and clients, has anything changed? What sort of feedback are you getting from them? Yeah. So I think the root of the question is really probably around, are we seeing any of the impact related to some of the biotech funding challenges that we all know is evident out there in the capital markets? And I would say for the most part, we're really not. And I think there's a couple of reasons to highlight. First off, as I mentioned through the presentation from a diversification of the portfolio standpoint, 60% of our revenue when you normalize for COVID is commercially approved products. Commercially approved products are obviously already products on the market, not impacted at all by any funding-related issues that some prospective or current customers may see. Of the 40% of our revenue, though, that is tied to development programs, I would say a large portion of that is tied to much more what I would consider to be later stage programs. Although we are active on everything from preclinical all the way through, as I highlighted in the presentation, we're much more weighted to later phase programs. And as you think about biotech funding or funding needs of any earlier phase innovator, if you're in that phase two stage, I don't want to say it's a non-issue, but it's as close to a non-issue as you can get in that phase two stage. Access to capital is very readily available at phase two. The other thing I would say that's helped us is, look, when you're in CDMO that has a finite amount of capacity, you can be a little bit picky and choosy in terms of who you do business with. And we're not in the business of picking the winners. We get paid very handsomely for all of the development work we do for many programs that we know will never materialize out through commercialization. But we do have the ability to look at certain customers, understand their pipeline, understand if there's multiple molecules in that pipeline, understand their credit worthiness. Are they going to have any issues? How much cash do they have today? What that looks like in the future? Are there any issues potentially on the horizon here? And that factors into the decisions that we make as a company from a commercial standpoint in terms of who we engage with. So long way of saying, John, we're not seeing significant impacts around this today in any material way. If there's a part of our business that could be the most impacted by this, I would say it's probably our Clinical Supply Services segment. That's where we're doing the logistical trial activity work, storage, distribution, manufacturing, packaging, et cetera. It's a fast turn business. We're working with small biotech, but all the way up through large pharma on that front. We have seen some BD-related challenges in there, which we highlighted on our last earnings call where we saw new business wins that were either flat to a little bit down versus where they were a year ago. But that's also the segment where we're feeling impacts related to China, related to what's happening in Eastern Europe. That's really the only segment that has exposure to those other areas where I would say it's tough to parse out exactly what's biotech funding related and what's just related to other economic challenges or issues that are happening around the globe. So that business, as I said, 8% of our overall revenue, but even smaller portion of that 8% is really tied to these types of customers. So something we're continuing to monitor, but again, no immediate impact that we're feeling. Thank you. Any questions from the audience? All right, I'll throw one more out. Any update on the Brussels sterile fill-finish remediation? So what we mentioned here on our last earnings call is that we have started manufacturing again at the facility. For those of you that aren't aware of the situation in Brussels, this was made public through disclosure that one of our customers at that facility has made. From our perspective, we didn't talk about this proactively because a 483, from our view, is a normal course. It's a way that a regulator communicates any observations from an audit that they conduct at a facility back to the company. It's not a warning letter or a consent decree or a removal of your license and forcing you to shut down. We did proactively take steps to stop manufacturing at the facility. We thought that was the fastest path towards some of the remediation efforts that were underway. We did that with the support of our customers on site, at the site as well, and again, on our last earnings call, we're in a position to be able to announce that we have started manufacturing at that facility, and I think the customer in question has mentioned in some of their disclosure that I believe that they will be in a position to supply the drug that was up for discussion to the market in the second half of fiscal 2022, so the only update I can provide, John, there is just, again, giving a little bit of background there, the understanding around the 483 approach there, as well as the public disclosure that's been made by our customer. Thanks, Tom. Okay, let's cut it off there. Again, Q&A in the Maher Room on the second floor. Thank you. Thanks, everybody.
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