Hey, the three of you here at the Global Healthcare Conference. Hopefully, it's been a great event for all of you joining on the webcast. Pleased to be joined here in the 11 o'clock hour with senior management of Catalent, which is a buy-rated stock here. It's been one of our top picks, actually published as our top pick today in a global or a US-oriented research note that was put out by our strategist. Really pleased to be joining with two members of the management team. We have Tom Castellano. Tom, who I got to know in his previous role in investor relations and subsequent to that migrating back into the company and now is recently appointed Chief Financial Officer. So really pleased to have Tom here to be speaking on Catalent's behalf. As well, we have Paul Surdez, who's head of investor relations. So please feel free, anyone on the webcast, if you'd like to try to ask a question to me, there's a question, I believe, icon. I'll check it throughout the presentation here. So maybe, Tom, listen, congratulations on being appointed the new CFO of Catalent. I thought the first introductory question might be to ask you, how should investors maybe think about your approach to being CFO and what impact this can have on the company? Yeah, great. Before I do that, Dan, thanks for the time and the opportunity. I just want to point everyone's attention to our SEC filings to understand the risks and uncertainties that may bear on the operating results and the financial condition of the company and that we may be making some forward-looking statements today. Besides that, obviously, really excited to join in this capacity, start to re-engage with investors and analysts. Had some great meetings this morning. Look forward to continuing the dialogue there. Just to give a little bit of background, I've been with the company for 13 years here. Joined back in 2008 under private equity, started out the financial planning and analysis group and put in some, I would say, robust financial reporting, analytics, budgeting, forecasting, all those processes as an early-stage company that you really didn't have in place. Played a big role in taking the company public, took on investor relations, was treasurer of the company where I interacted with you as well as others on the phone during that time. Recently spent the last year and a half as the global VP of operational finance for the company, owning finance operations for all of our business units. Spent most of my time as business unit CFO for the biologics business, including cell and gene therapy, big areas of growth and focus for us. Really played as Wetteny's right-hand person. Thrilled to get the call up here and the opportunity to step into the CFO role. To be able to do it coming off the heels of what's been probably the most exciting year that Catalent's ever had since our inception is an understatement. The company's in an extremely strong financial position. We're coming off a significant quarter here in Q3, which we just put our public financials out a couple of weeks ago there. We were in a position again to once again raise guidance here, looking at 27+% revenue growth here at the midpoint of that range in the current fiscal year. And the piece of this that I'm most excited about is the quality of the balance sheet that I'm inheriting. We've talked about a long-term leverage ratio of three times, sitting at 2.3 today, significant firepower and opportunity if we wanted to continue to be acquisitive. Just really, again, excited for the opportunity. And in terms of the transition from Wetteny here, I would say not much change here in terms of the investors and how they will feel this. I mean, I think my priorities are very similar to that of Wetteny, making sure we have a strong capital structure, which we do, a strong balance sheet, making sure that helping guide and lead the strategic growth initiatives of the company, which I'll continue to do, and I would say making sure that I get out there and spend good quality time with investors and analysts, which is really important for the role, so not much of a change from a transition standpoint. Catalent's big on succession planning. When John asked me to take the role a couple of weeks ago, the first thing he said is, "Now, you need to figure out who your successor is here," so that's just the mindset that we have of the company and how we think about that. So again, looking forward to the opportunity and working with you and the investors in the new capacity. Awesome, Tom. Thank you for that. I thought I had a series of questions to go through, so hopefully we'll be able to get through most of the 45 minutes, so I thought I would dive right in. Topic du jour is kind of the ability for Catalent to handle COVID and all the strong volumes coming your way, which has been a really remarkable kind of execution that you guys have delivered, but when we think about teasing out COVID versus non-COVID, in the last quarter, biologics overall, I think, grew about 113%. The company talked about the majority being from COVID. We're all hungry to understand how much COVID is contributing, and I understand it's kind of fungible, so it's not easy to separate, but in our assumptions, we assume the base business grew, call it like 36% in biologics ex-COVID with 77% from COVID. Is that in the right zip code? Can you help us think about the splits? I think it's an important element for investors to have clarity on. You're right, Dan. I mean, we did highlight that the bulk of the growth that we saw in biologics was COVID-related. I can't comment specifically on your model and the assumptions that you've made. What I will say, though, is directionally, the COVID business is difficult to parse out, as you said. There's products that fit in there that are now being used for COVID that were still in the portfolio and in the pipeline that may have not been considered for COVID use at the time. So where do you put that? Does that become a COVID product? Does it not become a COVID product in terms of how you quantify that? When you look at available capacity that was then being utilized for COVID vaccines, but we had pipelines of molecules and drugs that customers wanted us to produce, but we had some challenges in doing so because of rated orders and whatnot. How do you classify that? That would have been used for COVID, for non-COVID, but was being used for the COVID bucket. So it's a difficult one for us to parse out. So I'm going to stay away from providing any specific, I would say, direction there, Dan. Otherwise, we are positioned well to continue to grow at the levels in which we've seen. We have some, I would say, strong COVID-related tailwinds that have helped accelerate the growth. Strategic investments of the company forced us to be a little bit more aggressive. With those investments that we've brought on, we've also seen an acceleration in the returns on those investments, which just gives us additional capacity to be able to continue to invest in the business to see similar growth rates to what we've seen. We've talked about biologics being a segment that should be growing in the double-digit range to mid-teens, obviously ahead of that here with the COVID tailwind that we're seeing. Sustainable growth at those levels is right within our wheelhouse, and we've been able to put together the strategic initiatives to continue that longer term. Okay, great, Tom. Thank you. Maybe ask on the Defense Production Act. I'm just wondering, could you comment on what kind of impact it's had on your production allocation in COVID versus non-COVID areas? And is it still having an impact in the current quarter? And how do we think about it going forward? Yeah, no, good question. So we did have a, I would say, a handful, is how I would describe it, of products that were impacted by rated orders and government requirements. I would say that's essentially started to improve here. We did have a small impact in our second quarter, probably a little bit more impact here related to that in our third quarter. But I think we're out of the woods here as we sit today in our fourth quarter. And that's a result of the new capacity that we brought on in Bloomington, high-speed fill line, which is 100% dedicated to COVID programs today. So it gives us capacity that we were utilizing elsewhere in the network or being forced, for lack of a better term, to utilize on COVID programs for other non-COVID-related work and programs. Our customers have been extremely understanding and flexible. We made sure we worked with them to prioritize in a way that patients didn't feel any of the impact from this and were fortunate to be in a position to say that we were able to achieve that. We delivered as much COVID vaccine as we needed to. We continue to produce at significantly high levels of utilization on that front, but have the capacity and focus to continue to provide other products and help our customers manage their supply chains and get key medicines to patients as needed. So it was a little bit of a headwind we needed to face in Q2 and in the third quarter, but believe that's behind us here in our fourth quarter and don't expect any headwinds from that to impact us as we enter the next fiscal year. Got it. Great. Well, you touched upon capacity, and obviously, that's been a big focal point in terms of expanding capacity and kind of accelerating that capacity expansion given COVID. We've tried to look at the impact that that could have and worked with Paul a little bit on this, but it's not very transparent or easy for us to see. So I'm wondering if you can give us a sense of the expansion that you've announced, just kind of remind us of the timelines for that capacity coming online, and how do we think about the revenue opportunity associated with the capacity expansion that you've announced? Yeah. So I think where we have to point investors to make sure that you understand is that there's very few announcements related to capacity that we were bringing on that was related to COVID specifically. We talked about the vial line, one that we were able to just recently bring online that is dedicated to COVID. But the other investments that we've announced going back to the 2019 timeframe when I was actually still in the investor relations side of things related to investments that we were making in drug product and drug substance out of our Madison facility and drug product out of our Bloomington facility, as well as some investments we're making in DP in Europe. Those were in flight way before the pandemic. That was based on the pipeline of molecules that we saw today and the potential anticipated capacity needs that we were going to have as these molecules work through development stage, progressing into later phase, and then ultimately working towards commercialization. So I would say it's hard for us to look at the capacity that we're bringing on a revenue basis. I would shy away from that other than to say this was not a build-if-you-build-it, they-will-come type of approach either. This was a well-thought-out deployment of capital based on a strong pipeline and the needs of our customers and being able to produce product at scale and the quantities in which they need it. And I'll talk a little bit more around the drug substance side of things. I think as we talk about COVID, we're really focusing on drug product primarily. That's where we're playing from a vial standpoint with a couple of major programs, both in the U.S. and Europe, out of our Bloomington and the Anagni facility. But within drug substance, that's where we play on the sub-5,000-liter single-use bioreactor. We announced in that same timeframe, 2019, that we were bringing on additional drug substance capacity. That's what we refer to as our fourth and fifth train, still small-scale manufacturing, but gives us the ability to scale up to more commercialized products. We still are yet to have our first commercial product on the drug substance side within our Madison facility, but we're certainly, I would say, nearing that and look forward to ramping up the capacity on the drug substance side to be able to keep with the growth rates we've seen in that business, which, again, has been in that, I would say, low to mid-teen range here. Cell and gene therapy is another area where we've been announcing additional capacity expansions. We've talked about our BWI facility down in Baltimore, which was what we acquired through the Paragon acquisition that we did several years ago. We have currently 10 suites up and running on the cell and gene therapy side of things or the gene therapy side, I should say. We've announced that we'll be bringing on an additional five suites sometime in our fiscal 2022 year. I think that would probably be close to the tail end, sorry, in the calendar 2022 year, close to the tail end of our fiscal 2022 is when we would expect to bring on those additional incremental suites. And then I would say further scale-up investments on the cell therapy side in discussion and in flight as well. So those are the capacity, I would say, improvements that we've made across the network that put us in a very good position across drug product, drug substance, cell and gene therapy to continue on the growth trajectory that we've seen. Thank you, Tom. Is it possible, just as a follow-up, to characterize? Well, not tied to revenue, I agree. That's kind of a hard thing to do because it depends what's going in there. But just from an aggregate relative expansion, could you highlight for us just kind of how much the new capacity coming online, what percentage increase it affords you across drug substance and drug product versus where you were previously? Yeah. So look, I would say if we look at our drug substance capability and what we have across, I mean, we still have a pretty small level of utilization, a pretty small level of capacity available. I mean, we're sub-30,000 liters in total capacity that we have on the drug substance side across our biologics facilities. And we've brought on two by 2,000-liter capability in our fourth and fifth train, which, as we said, we'll start to slowly ramp as we wrap the year here and primarily as we get into our fiscal 2022 year. From a drug product perspective, what I'll say there is COVID had put us in a little bit of a capacity crunch where we were operating at higher levels of utilization than we would have liked or felt comfortable with. I think if you think about the sweet spot from a CDMO perspective, at least from our standpoint, in terms of drug product or many of the other filling lines that we have across our other BUs as well, you kind of want to stay in that 80%-85% capacity utilization. As you close to 100%, your margin for error becomes smaller and smaller, and we need to be able to pivot and switch products, move from customer to customer or program to program. It could be challenging to do so at those high levels of utilization. So with the new investments that we've been able to make and the additional capacity that we've been able to bring online, we've been able to reduce our overall capacity utilization on the drug product side to be below that 80%-85% max capacity to give us the ability to continue to grow both with COVID programs as well as with non-COVID programs. As I mentioned, our pipeline remains the strongest it's ever been on the non-COVID side. So a huge focus on our BD teams to make sure that we're not just taking our eye off the non-COVID ball, and the only thing that we're focused on is making sure we're able to produce vaccines. So it's in a much better place from a capacity utilization standpoint within our comfort level, but still having ample capacity available to continue to grow with our customers and their programs. Great. Thanks, Tom. That's helpful. Just in terms of, I know we'll get through the fourth quarter, and then we'll get your outlook for fiscal 2022, so we're not going to get any real details today, obviously. But just conceptually, any way that we could try to think about the COVID benefit for this year, 16%-18% revenue impact, so around $500 million. What are some of the factors that you would look at to try to think about where that could go as we get to fiscal 2022? In our model, we have it up a little bit. We've kind of looked at developed markets and emerging markets and made some assumptions on boosters and just tried to look at a high-level volume shakeout. So we have it up a little bit, but I'm sure there's a wide degree of variability. But just anyway, what are the factors that you think that we could try to look at to try to think through what the impact could be for you? Yeah. So good question. Obviously, a big focal point for investors to try to understand what '22 means from a COVID standpoint. What I would tell you is our comfort level around COVID continuing to be a meaningful contributor for us in fiscal 2022 is high for a couple of reasons. Obviously, you mentioned the need for potential boosters, the variants that we see continuing to pop up across the globe, and although we feel like as we start to return to normal here in the U.S., and in fact, I'm back in the office now and have been for some time, we forget that the rest of the world is in a much different situation in terms of vaccine availability and rates of vaccinations in comparison to what we see here in the U.S. So we do think we continue to be in, I would say, relatively early to mid-80s in terms of COVID and what the contributions for us could look like. I would say as you start to think about next year in fiscal 2022, which, by the way, we have seen a couple of the major players that we're working with in a partnership way around COVID vaccines announce extensions, for lack of a better term, out into very late or towards the tail end of or towards the end, I should say, of calendar year 2022, which essentially covers us through our entire fiscal 2022 period. So that, again, leads to the level of confidence and comfort that we have around COVID continuing to be a player and contributing for us into fiscal 2022. In terms of whether it's up, down, or flat, I'm going to withhold comments around that one until we run through our modeling and our budgets, which we're in the midst of pulling together as we speak, and we'll provide additional information related to this as we guide in the tail end of the summer ahead of our fiscal 2022 year, but what I would say is the level of COVID uptick in vaccinations that we're seeing really started at the tail end of our Q2. We saw a full quarter's worth in Q3. We expect to see some similar contributions from COVID in Q4, so we will see a little bit of a tailwind that should carry into our first fiscal quarter, at least, of next year, where we were doing more tech transfer or earlier stage development work versus commercial manufacturing and high levels of utilization. So I will say that that will be a little bit of a tailwind. But putting all this in a blender and understanding exactly what those moving pieces look like, excuse me, what those contributions will be like for us into fiscal 2022 will be something we get into more detail when we release guidance, as I said. Great, Tom. That's a good way to think about it. Maybe just a question on potential IP waivers. To the extent these go through, and frankly, I haven't scrubbed the news wires in the last couple of days here with the conference, I'm just wondering, what kind of impact would that have on Catalent? Yeah. I don't see this as a risk at all, to be honest. We're not expecting any meaningful impact related to this from any changes from an IP perspective, I would say. The IP is not with us. It's with our clients. The role that we play in helping produce and bring vaccines to market. We've been shown the track record to be able to do that successfully within the demands of the global pandemic and our clients. I would say that role that we play continues to be important regardless of who the innovator is for these particular programs. And I would say given the technical expertise we have, the strong operational quality track record, and what we've been able to show through the pandemic year and our ability to deliver, we don't view this as a risk in any way. Great. So we talked a lot about COVID vaccines. I just wanted to. I'm sure you've gotten my questions throughout the last couple of quarters, but COVID therapeutics. What have you disclosed? How do we think about the therapeutic opportunity for Catalent? Yeah. So therapeutics have been an opportunity. I mean, I think we've put out numbers in the past around the number of programs, 50-plus programs that we've been working on across the company, really touching almost every one of our business units in terms of COVID in some way. What I would say is, simplistically put, there's more therapeutics that we're working on than there are vaccines, but the revenue dollars associated with therapeutics is significantly smaller than it is for vaccines. And I think that will just continue. That gap between those two will probably just continue to get wider and wider. Although we're pleased in the role that we're playing on the therapeutic side, where we're working on both drug substance, drug product, and as I said, some of the other business units as well. I think what the meaningful drivers for us will be in terms of COVID revenue would be more around the vaccines and the high volumes in which we're producing there versus that of the smaller scale therapeutics, although still important nonetheless and a big focus for us. Great. Maybe just before we dive into the base biologics business, so just kind of a question kind of juxtaposed in the middle of this conversation, maybe I should have asked it upfront, but nonetheless, I know your long-term guidance calls for 6%-8% organic revenue growth, 8%-11% EBITDA growth. You've talked about a fiscal 2024 revenue target of $4.5 billion. Obviously, given all the growth from COVID, the accelerated CapEx that sets you up maybe to fill demand earlier, is it fair to assume that there's upside to these growth targets, or just how should investors think about them? I'm actually surprised it took you this long to get to that question, Dan. Look, I would say when we put that long-term growth outlook out related to the $4.5 billion about a year and a half ago or so, it was obviously pre-pandemic. We had line of sight to $4.5 billion of revenue with about 50% of our revenue tied to biologics. At that time, at the time as well, we thought we'd need some small tuck-in type acquisitions that were likely to come to fruition to get us there. Fast forward where we are, 18 months later, obviously in a very different position where we've been able to grow the business and participate in the response to the global pandemic. We're facing ourselves here in fiscal 2021 with a revenue number that's going to be close to approaching $4 billion at this stage, which certainly, I would say, wasn't in play with biologics, at least in our third quarter as a proxy already being north of 50%. Whether or not it ends the year in that range, we'll see. But I would say we're really happy with the position that we're in. We do take a look at our long-term growth outlooks as part of our strategic planning process every year. We just wrapped that up. Just came off our board meeting talking about our strategic plan and what that looks like for the next five years. At this point, we're certainly not in a position to make any change in the midst of a fiscal year, in the midst of a global pandemic to our global outlook or our long-term outlook, but certainly very pleased with where we're at. Still some work to do on the margin side. We talked about a 28% EBITDA margin as part of that disclosure as well. We'll add 100 basis points or so based on where our guidance is in fiscal 2021. So still some work to do there in order to get to that long-term target. But yeah, certainly really happy and pleased with what we've been able to accomplish where we are from a financial contribution standpoint here. And we'll continue to look at these items. And if there's obviously any changes that we decide to make, we'll certainly communicate that out. But right now, that continues to be what our long-term target looks like. Got it. Excellent. So maybe a few questions on biologics ex-COVID. So kind of your characterizers are your base biologics. We'll discuss gene therapy. So maybe you want to discuss traditional monoclonal antibodies. Just how would you characterize the demand environment there? How are you positioned? I'm wondering, of all the CapEx that's occurring globally, does that create any risk to whatever kind of growth rate that you've been expecting for that business? Yeah. Look, I would say there continues to be a supply-demand imbalance within this side of our business that I would say has only been exacerbated by the rush for COVID treatments and vaccines. I think we are very much focused on making sure that we continue to have a robust pipeline of programs that we're working on, both within the drug substance, drug product side on a non-COVID basis, and within cell and gene therapy as well. As I mentioned, we're investing in all three of those areas through organic CapEx investments for continued growth opportunity and potential outside of COVID. It's been a real focus of the management team as well to ensure that we have the right, I would say, business development focus on not just COVID. We had our operating review with the teams two weeks ago and sat down and asked that we make sure that we strip anything COVID-related out of our pipeline funnel and wins to make sure that we're still winning at the levels necessary, bringing in new programs on a non-COVID basis to continue with the growth trajectory that the company expects to be able to deliver on. We're very well focused in making sure that that's the case. I would say we are seeing investments from other players in the space. Certainly nothing that I would say concerns us in any way. We have line of sight to the continued levels of growth within biologics in that low to mid-teens that we've talked about over the five-year strategic plan period that we look at. I would say the position that we're playing in terms of COVID and the role that we're playing in helping get the world past this pandemic, I would say, is a business development tool in itself. Catalent's brand has never been stronger. And I think our ability to continue to operate with high levels of quality and expertise, having available capability and capacity, and being able to deliver what we have from a COVID vaccine perspective is certainly going to help us ensure that we remain a top player in this space from a non-COVID perspective as well. So all things, I would say, we continue to be really bullish on this market and are putting the right, I would say, strategic initiatives in place to continue the growth trajectory here and feel confident in our ability to be able to deliver there given the position that we have in the industry and in the space. Great. Okay. That sounds good. I know some of your peers have certainly put up good numbers as well, really strong growth the last couple of quarters. So maybe just switching over to gene therapy, you've already touched upon the capacity expansion plans and when you're going to have those five new suites kind of up and running. Just how do we, I mean, one topic we've explored and we've tried to think through is just the potential impact as you go from a nascent commercial market to a larger commercial market, what the impact would be for Catalent. So how should investors really think about that when you go from patient volumes in the tens and twenties up into the hundreds and thousands, essentially, that could potentially lead to a real inflection in a growth rate I assume is already at a really robust level? Yeah. Look, I would say that that's what we face really every day as a CDMO in all of our technology offerings, not just in cell and gene therapy, right? I mean, where we really earn our money is when we're able to lock in a long-term commercial contract for the production of a drug, regardless of whether it's a cell and gene therapy or whether it's an oral solid or whether it's a soft gel drug or a DP drug out of our biologics business. What I would say there, though, is the important point of note is that diversification of the portfolio is a huge part of things and a huge part of the strengths, I would say, of Catalent as a company, right? We're not tied to an individual product. We continue to have low levels of concentration from individual products across the company. And that's going to continue to maintain within our cell and gene therapy business as well, where we're not going to be banking on a key product or two and becoming commercial as to whether or not we're able to achieve the levels of growth that we've committed to around this business. So I would say we continue to have a very robust pipeline here. We're working on over 100 programs within cell and gene therapy. As things go commercial, I would say it brings a little more stability and less variability to the overall revenue picture within the business. But I wouldn't expect some significant step-up in terms of revenue growth as a result of a commercial product or two because of the curative nature of these drugs within cell and gene therapy. You can end up seeing a significant increase in volume, but then you can see a little bit of a trough there. After that, you're then backfilling with the next molecule that's going commercial. The one thing I will say, one of the things we really like about this business and the sector in general is because of the curative nature, because we're dealing with smaller innovative-type biotech companies here within the space, that they're very, very reliant on CDMOs and outsourcing, and we are a leader in this space for sure. We have the ability to scale up to meet their needs as their products move through later phases or stages and ultimately towards commercialization, and the level of outsourcing that we see within cell and gene therapy is far greater than it is in any other part within our business. So for all of those factors, we continue to view this as a really great growth story for the company and one, as you mentioned, we continue to invest in and focus on. In terms of the slotting fees, I know that John and I guess Wetteny have talked about in the past, are those still occurring where customers, where demand is so strong, the capacity is so tight that you've been generating revenues by just kind of booking space even though the companies aren't really using it today? Yeah. I mean, that's certainly a tool that we continue to have at our disposal and use when we get the ability to, in terms of locking in capacity, because clients are looking to make sure they have space for when their product is at the stage in which they need higher levels of productivity, and they don't want to wait for production. They don't want to wait for that to occur and then there not to be any capacity for them to be able to grow with. So yeah, I wouldn't say it's something we see on every contract, but it's certainly a tool that we continue to utilize here when we can be a little bit more choosy in terms of who we're bringing in and what's the phase of their program and do we want to, are these customers willing to reserve space to ensure that it's available when they need it. I know when you did the Paragon, you guys gave some kind of size of the market and a relative growth rate or maybe Thermo discussed when they did Brammer. They talked about maybe a 25% growth rate or thereabouts. Obviously, I think the growth rate was a lot higher initially. Any way for us to think about it? I know you don't disclose the details within biologics, but if we're trying to think about this particular area, is there a way to think about implicit in your long-term guidance what this segment of the business grows at? Yeah. No, we haven't talked about that, Dan. So we're going to stick to talking about biologics as a segment where we have talked about low to mid-teens growth rate. I think you got to look at the individual pieces that we have: drug substance, drug product, cell and gene therapy. They're not all growing at the same level of rates, but I would say on a blended basis, we end up in that low to mid-teens rate. This is one of the exciting parts of our business in cell and gene therapy as well and where we continue to invest and see some great, I would say, margin profile of the work there and potential for expansion there associated with this business as well. So I'm not going to talk about specific numbers for it, but obviously, as you mentioned, an exciting growth opportunity and the level of outsourcing that we see around this business I already highlighted is far greater than elsewhere in our network, which can only help from a growth acceleration standpoint. Got it, and then maybe one more, and then we'll switch to other businesses. Just on cell therapy, it's been a while since the MaSTherCell deal occurred. Just how do we think about or what kind of disclosure will you provide or how do we think about the benefit of your cell therapy offering? Just is it contributing meaningfully today? If not, at what point do you think it could actually become a real driver within your biologics segment? Yeah. So look, this is a smaller business that we brought on for the MaSTherCell acquisition. As you mentioned, we've continued to look at small little tuck-in acquisitions around this. It's in early stages in terms of its growth. I would say it's integrated well into the Catalent portfolio. It's now approaching or it's over a year as being part. So from an integration standpoint, we've been able to complete that. There's a facility in Gosselies, Belgium, one here in the U.S. in Houston as well. We're still working on the investments necessary to scale this business. So you're not going to hear us talking about the financial contributions from it. We did get it at an early stage. Good pipeline associated with this, one we continue to sell into and look to continue to ramp and grow with the base business. But off to a good start, I would say, as part of the Catalent portfolio. Got it. Okay. So softgel, I know during the quarter, you guys highlighted this reduced demand for prescription. Given the pandemic, those trends were improving. Just kind of wondering, how do we think about the outlook for this business? Just kind of remind us on some of the COVID-related headwinds and kind of where we are. We're kind of cycling through those. Yeah. SOT was the business that I would say was impacted the most by the pandemic in a negative way. We saw cold, cough, flu-type products as well as pain, acetaminophen, and ibuprofen-type products start to, I would say, start to decline in the fiscal year. This is a business, though, that was up against some pretty challenging comps, 2021 versus 2020. We saw the reverse effect, actually, in our third and fourth quarter of fiscal 2020 within this business, whereas we were entering the talks of a pandemic. We saw a little bit of, I would say, an increase in stockpiling of cold, cough-type products. Then we went to a period of time where those were no longer being utilized, for lack of a better term, around patients that were quarantined and not getting sick. And I would say we saw a decline around those products in the fiscal 2021 time period. I would say it's taking us a little bit longer than we had originally expected to see the turn of the corner around SOT. I'd say we've taken a pretty realistic look in terms of what SOT's contribution is expected to be as part of the fiscal 2021 guidance. So that's already taken into account in the guidance that we put out earlier this month. And these are the types of conversations we're having about the recovery of this business as a management team around our fiscal 2022 budget and our strategic planning process. And obviously, we'll have all of those inputs and make that determination around what does that business look like heading into fiscal 2022. So we'd love to say that we're starting to see a recovery year. We are, to an extent, slower than what we thought. What it means for fiscal 2022 around the growth prospects and whether this can return to the low single-digit growth that we see out of this business out of the gate, still more to come before we're comfortable to be able to say that for sure. We'll make sure that we give additional color around softgel and oral technologies and what it looks like for next year as part of our Q4 earnings call around the trends of the business as well as what its contributions are to the guidance. Great. Now, thanks, Tom. We have about five minutes left. So just maybe cycling through your other businesses and then we'll get to CapEx and maybe M&A to end it. But just in terms of, I always see you guys highlighting the headwind from this drug recall, which occurred last September. So just in terms of framing the magnitude of that, and I mean, obviously, it feels like it'll probably persist, obviously, this quarter. It'll probably still be a drag in the first fiscal quarter of 2022. So I have to believe that thinking is correct. But in terms of framing the size or the magnitude of that drag, just kind of walk us through. Yeah. No, I think you're spot on in terms of your timing around this. Look, we saw a pretty big hit from it in the third quarter here, especially because of some of the one-time costs associated with the recall. We did have this product running in the fourth quarter of the prior year. It happened to be a product that also had not only manufacturing revenue for, but also had product participation revenues associated. So relatively high margin. It will be a tailwind for us in the fourth quarter, already again contemplated, reflected in the guidance we have out there. I think you're thinking about where we'll see its impact in fiscal 2022 as well, and we'll give a little more color to that, as I said, when we release our earnings and provide guidance. But in terms of the timing of the headwinds that we've seen from this, you're thinking about it the right way. Got it. And kind of the underlying 5%-7% growth for OSD, I mean, could you just give us a high-level, kind of a softer question, but just when we think about kind of the confidence level of growth as we cycle past this issue, does that remain kind of the right way to think about that business? Yep. Yep. Absolutely the right way. I would say Zydis, Zydis, Zydis, right? Zydis technology that we have is a big part of that growth driver. The Zydis Ultra that we'll be launching around that, which gives us additional drug loading capability, is going to be a part of that driver. We continue to see a robust pipeline within the early-stage development businesses that we have, as well as some investments we've made around technology such as spray drying within this business. So yeah, I think the 5%-7% that we've talked about is something we're extremely comfortable with when you normalize for the headwind here that we have related to the one respiratory product that we already talked through. Got it. And then maybe I'm going to skip over clinical supply right now, not to diminish that business, but continuing to follow. So CapEx, you talked about remaining elevated here. Just where do we kind of, what do you think the right level of CapEx is as we cycle through these recent significant expansions that you've done? Yeah. So we've talked about that 14%-16% of sales in fiscal 2021. We've said that we expect to see an elevated level as we get into fiscal 2022 as well. I'm not saying at this time that it's exactly within that same range. I wouldn't expect it necessarily to be higher than that range, but it will be at elevated levels in comparison to what our normalized rate is, which I would say is probably something closer to 9%-10% of sales. Will we get down to that level as we get into fiscal 2023? I mean, time will tell. We'll see. It'll depend a lot on capacity utilization and what kind of growth we're seeing around some of our key segments and the new capacity that we're bringing online within there as to whether or not we need to continue to invest at this level. But I would say we should see the elevated level through fiscal 2022, and then it starts trending down towards our normalized 9%-10% thereafter. Got it. And then we just have, I think, two minutes left here. So maybe, so M&A, you kind of led off early on the discussion with the strength and the balance sheet where you sit today. What should we be thinking about from an M&A CapEx deployment perspective? The Catalent size of deals, timing, pipeline, needs? Just any color you can provide. Yeah. Look, I would say obviously really pleased with the balance sheet position we have today. I mean, at 2.3 times leverage, lowest levels of leverage we've ever had as a company. We've talked about a long-term outlook of three times leverage there. If you do the math, I mean, that gives us a significant amount of firepower. We've also talked about, for the right deal, being comfortable going up at half a turn above our long-term target, provided we can delever back down to our long-term target within a 12-18-month period, which I would say we'd be very comfortable in doing so, just given the growth trajectory we've been able to see from an EBITDA standpoint. We also have $1 billion of cash on the balance sheet to factor into that firepower calculation as well. So well-positioned to be able to continue to be acquisitive on an as-needed basis. I would say, first and foremost, though, I have to say we're an organic growth company. We're deploying capital at significant levels, as you mentioned. We're accelerating the returns we're able to get on that capital investment through some of the utilization we're seeing from COVID. But there'll be deals out there for us to do. We've not committed to doing a deal or two deals a year. We've not talked about what the revenue contribution you can expect each year from M&A is, other than we're going to continue to be, I would say, good stewards of capital. We'll look at filling strategic gaps that we have in the portfolio through M&A if needed. And as we said, have the right level of cash on hand and balance sheet capacity to be able to do something sizable if the opportunity presented itself. So excited about being in that kind of position as a CFO of the company. Awesome. Well, Tom, I've had you on the firing line here for 45 minutes. So appreciate handling all the questions. And obviously, congrats again. And thanks for participating here at the conference. Appreciate it. And hope you have a great set of meetings for the remainder of the day. Great, Dan. It's been a pleasure. Appreciate the time. And look forward to continuing the dialogue. Okay. Awesome. Thanks. Thank you.
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