Thank you. Hello. I'm Juan Avendaño. I am part of the Life Sciences Tools Equity Research Team led by Derik de Bruin at Bank of America. I focus on biopharma services, namely CROs and CDMOs, and I'd like to thank everybody on the webcast for their participation. Please feel free to submit your questions through Veracast. It is a pleasure for me to conduct the following fireside chat with Catalent. We're joined by their current CFO, Wetteny Joseph, incoming CFO, Tom Castellano, as well as Paul Surdez from Investor Relations. Gentlemen, thank you once again for your participation. Thank you, Juan. I guess, to set the stage, would you like to do a few opening remarks on the company and also talk about the CFO transition that was announced yesterday? Sure, Juan. Thanks for that. Look, first, before I get started, I'll just point out that I may make some forward-looking statements today. So I'd like to refer everyone to our SEC filings to understand the risks and uncertainties that may bear on our operating results and financial conditions. With that, I'm just absolutely thrilled to be reintroducing Tom Castellano to our investors. He's a very familiar face and name to most of our holders, given Tom was in the investor relations seat before. He was instrumental in the company's IPO going back eight years ago and throughout the roadshow, partnering with John, our CEO, and our former CFO, Matt Walsh. Tom has not been visible to our investors the last couple of years because he has been steeped in our businesses. In fact, he leads all of our finance teams that are in the business units, and he individually leads as effectively the CFO of our biologics segment, where he's been working side by side with the business unit president there in the middle of all the capital deployment decisions and business cases and so on. Couldn't be more thrilled to be reintroducing Tom as our next CFO, and I think this demonstrates the bench that we have at Catalent and the seriousness that we take when it comes to succession planning, where we have internal processes multiple times a year, and then we go to our board of directors once a year with one of those meetings particularly focused on succession planning, where we can identify individuals that are ready now versus those that are ready in one to three or three to five years. We then put plans together to further develop them to be ready for moments like this. It's a very difficult decision to be walking away from Catalent, given all the opportunities we have ahead, despite the successes that we've had, but going to an opportunity and be able to turn it over to Tom, who's been my right hand for a long time. He's been with the company for almost 13 years as well. Welcome back to our investors, Tom. Yeah, thanks, Wetteny. Juan, obviously, look forward to continuing to work with you, especially in this new capacity, and look forward to reengaging with investors. And we'll be doing so very, very quickly right out of the gate here. So thanks for the opportunity. With that, I'll just make a few very brief comments because I want to get to your questions, Juan. Our responsibility has been to our patients and our employees so we can continue to manufacture the essential products. The response and our involvement with COVID-19 has actually accelerated our strategic growth plans, which positioned us well for sustainable growth in the future. And we've had really robust organic growth throughout the year, which continued into our third quarter and enabled us to also raise our guidance while we also tighten those ranges. And we have a very strong balance sheet with our net debt leverage at 2.3 x, which gives us the flexibility not only to continue to deploy capital organically, but to also capitalize on the inorganic opportunities that might accelerate our existing strategic plans. So keeping it very brief here and just turning it back to you, Juan, for questions. Thank you. I appreciate the background there. Starting with one of the recent developments ever since you reported, so last week, the U.S. said that it would support waiving patent protections on COVID-19 vaccines. Can you give us your thoughts on this matter and what the potential impact, if any, that it could have on your business? Absolutely, Juan. Clearly, the world needs vaccines. The U.S., the U.K., and very quickly, I would say, catching up is Europe in terms of vaccinating the population to really take hold of and see potentially the end of this pandemic, and there are places outside of these geographies that are well behind and need vaccines, so I can certainly understand the motivation to be looking for solutions that might help speed that for the betterment of humankind. This sort of flexibility, I would call it, in terms of the IP protection, just is difficult to see that making an impact within a time that would actually be effective or beneficial. I think it would take years to actually see that potentially cause a ramp-up of capability, capacity, etc., while truly, I think the challenge here is really around the supply chain and complexity of that and the ability to get materials and so on, which I think the focus ought to be on that more so than freeing up IP protection, which I think it would be measured in years, quite honestly. So certainly appreciate the motivation and want to see things that can speed this up more to be able to have more of the world vaccinated. It's just hard to see how this would be the solution. Thank you. And just hypothetically speaking, if the patent protections were to be waived, if that were to become a reality, what would that mean to your capacity expansion plans if more CDMO players came into the picture? Is there enough biomanufacturing demand outside of COVID-19 to fully utilize the capacity expansions that you have planned for in the future? The short answer is yes. We became central to the response to COVID-19, not because of vaccine or COVID-19 specific focus, but a broader market demand and moves that we've made both organically and inorganically to position us to capitalize on those. Whether you look at biotherapeutics in general, where we made the first move with quite essential organic moves with our medicine operations, adding trains to the drug substance, specifically in the sub-5,000-liter segment, and then drug products when we meaningfully increased our presence there with the acquisition of Cook Pharmica back in 2017, and then getting into the newer modalities with gene therapy and cell therapy and so on. Those have been the moves that we then deployed capital organically to scale. As we were in the middle of that, you saw the impact, given the pipeline is more than 40% biologics. We were substantially below that. We were increasing prior to the pandemic. You would have seen us go all the way to about 33% by the third quarter last year from more like 22% or 23% in the year prior to that. You are seeing that come to fruition as we continue to, and then the pandemic really was an accelerator for our strategic plans to continue to drive a greater percentage of our revenues in biologics unrelated to vaccine production and COVID-19. So there is, as hypothetically that you describe, it is just hard to see how that impacts the greater sort of strategy that we are in the midst of before COVID-19, that will be non-COVID-19 being impacted by this hypothetical. Juan, I would also just jump in here and mention that Catalent historically has not been a huge player on the vaccine front. And I think what we've been able to do and accomplish as a company over the last 12-1 8 months has really put us on the map and opened up another window of opportunity for us here on the drug product side with regards to vaccines. So I think that's going to help accelerate some of the potential utilization of the capacity that we brought online as well. Thank you. And while we're talking on capacity, I mean, can you give us a quick recap of your capacity expansion plans? What's been completed so far in 2021? What's work in progress? And what sort of projects will that new capacity be allocated for? Yeah, Juan, look, as we mentioned on the 3Q call, we're really encouraged by the continued increased volume and commercial activity we're seeing with our customers, not only with respect to COVID, but unrelated to COVID as well. We've experienced that across our biologics segment offerings this year. Clearly, we have the vial lines that we added in the U.S. within our drug product facility in the U.S. and bringing up to speed as well. Pre-filled syringe, high-speed lines as well that clearly are not being used for COVID-19 or position as well in terms of non-COVID growth here, as well as existing capacity we have in Europe for pre-filled syringes. We also are enhancing our capacity in Europe around vials. Clearly, we bought Anagni that came with existing capacity, and we're adding to that as well. Plus, we announced the addition of fill-finish enhancements in our Limoges, France facility that would give us flexible filling lines as well. So across our biologics offerings, and not the least is the addition of the fourth and fifth suite in our Madison facility, which is strategically important as we go from largely entirely development stage programs to be ready to do commercial operations in drug substance, all being in that sub-5,000-liter. The addition of the fourth and fifth suite essentially doubled our drug substance capacity as well. So all of these have been in the works for some time. Very pleased with the progress we've made through completion of these various elements, including those that are still in flight, like the [little bush one]. Thank you. Now, moving on to COVID-19 and the durability, which is a key topic with investors, and so in your fiscal year 2021 guidance, you expect COVID-19 to contribute 16-18 percentage points to revenue growth, which is a little over $500 million at the midpoint per my math. Now, when you evaluate the following developments, number one, the fact that vaccine developers have been increasing their production targets. Number two, the fact that you're adding capacity, when you also look at the scheduling for these vaccine deliveries, it seems like the vaccine manufacturing activity is scheduled to pick up or be greater in the second half of this year, calendar year, versus the first half, and Catalent's fiscal year ends in June. When you put all of this together, I know that you haven't provided fiscal year 2022 guidance yet, but it just seems that the COVID-19 revenue in fiscal year 2022 could likely be bigger than in fiscal year 2021. And so do you have any thoughts on or feedback on the thought process, and how durable do you expect the COVID-19 business to be? Yeah, sure. Juan, I'll jump in here. Look, I'm not going to debate your math. I think it's accurate. I will tell you I do agree with your assessment here as well in terms of the contributions of COVID-19 in fiscal 2021. We saw a significantly higher contribution in the third fiscal quarter than we did in the first half. We expect to see similar contributions in our fourth quarter, especially as we continue to bring on the new capacity on the drug product side, as Wetteny and you both highlighted. So can certainly understand how you're calculating a potential fiscal 2022 impact. Obviously, we'll fall short here of giving any guidance other than to say that we have put in place or at least publicly announced some key extensions with many of the key players that we've been working with here on the drug product side in terms of vaccines that go out well into late calendar year 2022, which covers us for our entire fiscal 2022 year. So we continue to feel quite, I would say, favorable around what's ahead here from a fiscal 2022 standpoint with regards to the sustainability of COVID contributions within the drug product side of the business. Yeah, I think in terms of durability, in addition to what Tom just alluded to, if you really watch and listen to what the major vaccine players are saying, they're really anticipating with not only vaccination efforts through the Western world and beyond, the variants and the need for boosters. And then you start to think about beyond COVID-19, what are the implications of, say, mRNA, broadly speaking, around vaccines in general. You can start to see some level of durability here as you watch that and as we talk to various, again, players in the industry in terms of what to expect out in the future. Now, again, we'll continue to look at those as we head into certain years and factor elements as Tom just alluded to. But I think as you look at the scenarios, it's a lot less likely that this is a one and done. You vaccinate everyone and you're done. Whether it goes all the way to the other end of the spectrum where you're vaccinating everyone every year, you can say, "Well, I wouldn't put a high probability on that, perhaps." But there's somewhere in between those extremes, you can start to see a level of durability even for COVID-19, and then start to think about beyond COVID-19, what might that mean. Got it. I appreciate both of your thoughts on the matter, and they're quite useful. So we've also heard about some preliminary indications that future vaccine doses and potential booster shots could be administered in fewer dose vials and even single-dose pre-filled syringes. My question is, are CDMO revenues in fill-finish and packaging affected by the packaging configuration? Why or why not, and how so? Yeah, look, I'll take this one, and Tom, you can add anything here. I think, Juan, there are too many variables here to get any level of precision. But I think a couple of things I would say for thought here is you can imagine if you were filling vials with, say, 15 doses and you go down to one or two, you could anticipate that you may have the same number of vials but in fewer doses. And that would translate into one thing in terms of if you think about the throughput through our factory and our equipment. We don't tend to, for the most part, across our business, have economics contracts that are tied to individual doses because you're going to still occupy the space and the equipment for a certain period of time if you're still putting out the same number of vials, for example. So I think those are things to really think about, but too early to start thinking about any level of precision and too many variables involved. In terms of pre-filled syringe versus vials, I think, again, you have to consider the extreme conditions, for example, mRNA vaccines have to be in, and whether that is something that you could see in a pre-filled syringe versus requiring to continue to be in vials. I will put that out there. But look, we have capability and capacity, state-of-the-art pre-filled syringe capacity across both continents in the U.S. and across Europe. In fact, as I mentioned earlier, part of the extensions that we announced even going back to early 2019 is adding a state-of-the-art pre-filled syringe capacity to expand here in the U.S. as well. So regardless of where things head, you can see where we may be able to continue to participate in those. Thank you. And obviously, there's been a lot of progress on the vaccine production ramp-up. But what would you say is the biggest bottleneck that you're currently seeing in vaccine production and supply? Is it the bioprocess materials, people, actual capacity, or any other? Look, I think it varies a bit, Juan, but certainly, it's a complex supply chain across the board. It was before the pandemic. Certainly, that has perhaps made it even more pronounced. You can certainly say the bioprocessing materials is a key one. We have people that are dedicated to supply chain and procurement activities, constantly working with our customers, by the way, who in many areas actually source those materials and send them to us to manufacture. But the elements that we take a lead on, we work with our customers as well and our suppliers to respond to the demand and the need here. But I would describe this as an active sport. Always has been, quite frankly, even before the pandemic, but certainly, it's one that we continue to have dedicated resources. We've been successful in terms of our ability to navigate through those challenges, but it is a complex supply chain. Thank you. Moving on to your long-term guidance, if we may. In early 2020, before the pandemic hit, you provided fiscal year 2024 financial targets with revenue of $4.5 billion, 50% biologics mix, and a 28% adjusted EBITDA margin. Due to the pandemic, I mean, you're well on your way to achieve and possibly exceed the revenue and the biologics mix target, in my view. But my question is, will you still stand by your 28% + adjusted EBITDA margin by fiscal year 2024, even if revenue comes well ahead of the $4.5 billion level? Yeah, Juan, I'll jump in on this one. It's a good question. Yeah, we're certainly ahead of our long-term expectations here around our mix of biologics in terms of its total contribution of revenue here. I think as of our third quarter, we're already ahead of that, looking at 55% of our revenue tied to biologics. With regards to the specificity around your question tying to margins, the $4.5 billion is largely driven by the significant growth that we see in biologics. The reason why we're ahead of where we were or where we expect it to be at this stage is because of that acceleration of growth on biologics. So biologics being some of the highest margins we have across the portfolio here. And if we are in a position in 2024 to have revenue above $4.5 billion, it will be because of the outsized growth of that biologics business. So long way of saying we're absolutely comfortable with the 28% EBITDA margin here that we're talking through in terms of our long-term outlook. Thank you. I appreciate the confirmation. So moving on to capital deployment and M&A. So Catalent has been active on the deal front this year, particularly in the cell and gene therapy space with the acquisitions of SCTS, Delphi Genetics, and most recently HCTS. However, these deals have been on the smaller side. And as you said in your prepared remarks, your net leverage ratio is 2.3 x at the end of last quarter. And so this is not only below your target of 3x, but according to my model, this is the lowest level since Catalent became a public company in 2014. And so can you comment on your M&A pipeline and current appetite to do bigger deals? Sure. First and foremost, I'll say that Catalent's number one focus in terms of achieving growth is through continued organic investments. But inorganic continues to be an opportunity that we have and a lever we've used in the past to accelerate growth. We've been very pleased with the acquisitions that we've done today. To your point, Juan, they have been on the smaller side, but that's not reflective of anything in the pipeline, but rather what's transactable at the time in which we're looking to deploy capital, right? I mean, there's a lot that goes into M&A. You have to have a willing seller. You have to have economics that make sense for both parties. And we continue to have a very strong pipeline of M&A potential opportunities to help accelerate our strategic initiatives. And those are small-tuck-in type sized targets as well as larger, more transformational targets. You're absolutely right as well around the low level of leverage. This is the lowest level we've ever been at as a company. We have talked about a 3x target, but we're not going to deploy capital and take our target up to 3x just to do it. It's got to be for the right transaction, and it's got to be for the right asset that makes strategic sense. So I'm not sure, Wetteny, if you have anything to add here from an M&A perspective. Yeah, look, while we remain, we have always been active in terms of assets that we like and we think that would be a good fit and help accelerate our strategic plans, we may influence somewhat the timing, but we don't control the timing. And so that's why it may look like you see the deals that we close, but the ones that we don't close, you don't hear about it. It's a multiple of what we actually close. So I think we never control the timing, but we remain disciplined as Tom described already. Thank you. Pivoting to the small molecule segments, staying a little bit away from just COVID and biologics. And so can you talk about some of the headwinds that you're seeing in these non-biologic segments, mainly the softgel segment and oral and specialty delivery? How long do you expect these headwinds to persist? Can they spill into fiscal year 2022? So look, Juan, clearly, we're a highly diversified name with multiple business segments that play different roles and are targeting different parts of the market. And despite some of the headwinds that you describe, largely related to COVID-19, by the way, as well, when we talk about the positive side of COVID-19, there are some pronounced areas like consumer health and cold and flu and so on that have been impacted negatively. These are transitory issues. And despite them, we're in a position now with the latest guidance to deliver between 25% and 28% top-line growth, with only two points of that being inorganic. So clearly, robust solid growth. And even when we back out what we're estimating to be 16% - 18% net COVID contribution, you can still see underlying solid growth from the rest of the business despite those headwinds. So we are confident in terms of the long-term ability for our segments to deliver growth in line with our long-term expectations. These transitory issues, in some cases with the pandemic impact, are lasting a little bit longer than we would have anticipated coming into it. But despite that, we're able to deliver the results that you're seeing. And we see some areas, for example, where development activities are robust, which sell well for the long- term. This is a long-cycle business in terms of when things become commercialized, but it's always good to see an uptick in development activity in our businesses. Sure. And staying on the non-biologics segment, you recently divested your blow-fill-seal business. Are there any other parts of your small molecule portfolio that you now may consider to be non-core? I would just like to hear your thoughts on your ongoing portfolio review and strategy when it comes to the small molecule segments. Look, small molecules, if you look at the development pipeline, are still more than 50%, closer to 60% of the pipeline, so while we continue to disproportionately deploy capital in biologics, double-digit growth in that market, etc., we will always have a level of small molecule in our business. Blow-fill-seal is a good business that we felt was in better hands with the divestiture, and it's healthy for us to always look at our businesses. We go into a full strategic review process annually, which culminates with a review with the board, and so we're constantly looking at our businesses to determine where the best opportunities are for us to deploy capital and what the returns might look like and whether any element would be in better hands, and we've done that in the past. We'll continue to do that in the future without any particular area to necessarily have any signals. We do like the portfolio. We do like a lot about where we play today, that nice balance between businesses that have good growth prospects, even if they're not at the higher end of the spectrum, but generate significant free cash flow that we redeploy into the longer, higher growth areas that require more scaling, and we like the way that overall works today. Thank you. One question that we've been asking some of our companies on ESG. Many investors are increasingly using ESG criteria to make investment decisions. What are some of the ESG attributes of Catalent and ESG initiatives that are being undertaken? Yeah, Juan, look, about a year ago, we published our first corporate responsibility report, and we're actually going to be releasing our second one soon that will cover our fiscal year 2020. The report is going to describe really how we extended and deepened our corporate responsibility commitments, and we'll also share some important achievements that we've made through fiscal 2020. I'll highlight a few here. We had the development of our first human rights statement, our commitment to even new targets for waste and water reduction, a transition of six of our sites to 100% renewable electricity, and completion of 50 energy-efficient projects. We've improved our low industry-leading recordable incident rate and lost workday injury rates have been improved and doubling the number of employee resource groups to eight. Each of those resource groups is sponsored by one of the members of the executive leadership team. And we made our largest ever philanthropic contribution total this year, where a substantial portion of that were gifts that were focused on the response to the interconnected COVID-19 and social inequity crisis that we faced over the last year. So again, we'll be issuing our next report. But we've deepened the relationships that we have with potential sources of talent and other HR providers that's going to really promote an even more aggressive, diverse talent recruitment and engagement and development initiatives as well for our company. So all told, really proud of what we've done and setting really even deeper, more aggressive targets for the future that we will be delivering on the ESG front. Thank you. With that, we're at the top of the hour. Wetteny, Tom, Paul, thank you once again. And for everybody on the Veracast, thank you for your participation, and we would appreciate your support in the upcoming proxy voting season. Thank you. Thanks, Juan. Thanks, Derik. Thanks, everyone.
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