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Stephens Annual Investment Conference 2023

Nov 16, 2023

Moderator

All right. Good morning, everybody. Welcome to the first fireside chat of the last day of the Stephens Investment Conference. I'm Jacob Johnson, Life Science Tools and Pharma Services Analyst here at Stephens. Thanks, everybody, for joining us this morning. Great way to kick off the day to have the team from West with us. We've got a whole crew. We have Cindy Reiss-Clark, the Chief Commercial Officer, Chad Winters, Chief Accounting Officer, and Quintin Lai, VP of Corporate Development and Investor Relations. This will be a fireside chat format, so I'll be asking questions, but I'll try to pause along the way in case anybody in the audience has questions.

Just, if the audience asks any questions, I'll try to repeat it for those listening on the webcast. So with that preamble out of the way, Quintin or Cindy or Chad, whoever wants to take it, I'll turn it over to you for any introductory comments, and then we'll start the Q&A.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Thank you, Jacob, and thank you to Stephens for the invitation to come to this conference. We always appreciate coming here. Unique venue, great mix of investors and companies that you have here. We really appreciate it. We look forward to a productive day today. West is celebrating its 100th anniversary this year. We are the market leader in primary containment and delivery of injectable drugs. Those are words chosen very carefully because first of all, injectable drugs, we're talking about one of the fastest-growing segments in the drug industry, led by biologics or large molecules. They need to be contained, and so that means that whatever that drug is comes in contact with, it needs to be stable, it needs to keep its potency, prevent it from any type of contamination, and not have any adverse interactions.

We are the market leader of elastomeric components, plungers, stoppers, for the containment, primary containment of those injectable drugs. We also do delivery devices, both wearable and auto-injectors, and then we also have a business of administration systems, the transfer of injectable drugs to prepare them to get ready for the patient, and then we have a contract manufacturing business, which does on behalf of a customer who has their own IP, we will do plastic injection molding in high volume, high precision manner to help support them. So, we look forward to your questions today, Jacob.

Moderator

Got it. Thanks for that, Quintin. Since we've got 45 minutes, I figure maybe just kick off with, like, a couple higher level questions and kind of for those maybe less familiar with the story, which I think most people are, but for those who aren't, just the, the first kind of value proposition, it seems to me, on the high-value product side is, is sterilization. Are any customers sterilizing their products themselves anymore, and is that how you kind of initially got your foot in the door on high-value products?

Cindy Reiss-Clark
Chief Commercial Officer, West

So, great question. So it's important—it's really important, I think, to recognize that our high-value product spectrum is really correlating and relates to the changing regulatory environment, of the industry, and so and the impact that that has on our customer and their drug. And so when we think about our products, you know, we, we can either wash the product, which basically is cleaning it to a certain level of quality, which is ready to sterilize at the customer's location, or we can wash and sterilize the product, and then it's ready to use at the customer's location.

You know, so basically, that whole spectrum, you know, we continue to work very closely with customers, and with the changing regulations, you know, we are certainly seeing, like in the past, customers may have invested in these type of processes themselves, but the trend for many years has been that, you know, this is our core business, and they expect us to manage those processes, improve the quality of those processes, so they can, you know, obviously focus on their resources, investments on the drug.

Moderator

Got it. That's helpful. And maybe thinking, moving up the higher value, the higher end of the high-value products, you know, whenever on your earnings calls, we hea`r FluroTec and NovaPure a lot. And I think NovaPure's a focus area, and we can talk more about that later. But can you just talk about what those products are and the innovation there and why customers are going to those products?

Cindy Reiss-Clark
Chief Commercial Officer, West

Right. So, you know, as Quintin said, that, you know, the fastest growing part of the injectable space is in biologics, and the nature of the biologic drug is that it has a sensitive nature. And, so when we think about that higher end, that's really where that, that's where that higher end spectrum plays, is in, in support of those biologic drugs. So when we think about FluroTec, FluroTec is a barrier technology, which is on most, if not all, of the biological drugs, and it's really a protective coat. It's a protective technology, that protects the nature of that sensitive drug. When we think about NovaPure, so NovaPure is a broader offering, and FluroTec is embedded in NovaPure. However, NovaPure was created, with quality by design principles, which really is resulting in it is at our highest level of quality.

In addition, it has our highest performance attributes for the containment system.

Moderator

Maybe just on, I hear Quality by Design, I hear high quality, and that all makes sense, but why does that matter for customers? Is it all about risk mitigation or, or?

Quintin Lai
VP of Corporate Development and Investor Relations, West

So Quality by Design is a manufacturing philosophy where you are doing checks and balances on every stage of the manufacturing process, including the supply chain. So if you can imagine, if you just do quality checks at the final product, you have a certain variability that you will have, you know, plus or minuses in terms of tolerances or the dimensions. In the case of Quality by Design, we are engineering in checks and balances along every way to tighten the tolerances, both on chemical composition, mixture, processing, dimensioning, all the way through. And so then, when you get to the final product, you have the tightest tolerances that you can possibly get through that type of step-by-step process. It is a lot of work.

But we believe that by doing so, you can get a better product, you can get better performance for that product, and we think that the customers get value and risk assurance that they're getting something that has been manufactured as carefully as possible.

Moderator

Maybe I was talking to an investor who's newer to the story the other day, and I, you know, I think people say you have roughly 70% market share, and I think it's higher in biologics, and this person was asking, "Well, why is that?" And I was like, "Well, they're really good at what they do, and quality, and maybe it's this innovation." Maybe the answer is Cindy is really good at what she does. But I'm just curious, kind of from your perspective, how do you maintain that market share and get the even higher share in biologics? Why do you win?

Cindy Reiss-Clark
Chief Commercial Officer, West

So as I stated, I mean, a bit of it is that offering, right? So they're a sensitive nature, and, you know, we like to say that the molecule picks the container, and it's about being able to protect the integrity and the quality of the drug, so it's safe for patients, and that is really what we do well. And that higher end of our High-Value Product - that upper end of the High-Value Product spectrum, you know, that is really where we focused. And, you know, the technology and the quality levels that we just spoke about, you know, that is a clear value proposition, and, you know, it continues to resonate with our customers, and we succeed that way. Okay.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Well, as we all know, Jacob, this industry feels fragmented, but I mean, when we look at some of our customers and some of the players at various customers, they started someplace else or maybe two other different places. They talk among themselves, and they know. So you know, as they're preparing their new molecule, right? You know, molecule X, to get ready to go through phase II, phase III. All right, so they're gonna sit there and go, "Well, what was the industry standard? What is the what do most people use?" And you'll probably start from there, and then you have to do your testing. You don't ever cut corners.

Cindy Reiss-Clark
Chief Commercial Officer, West

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

We never cut corners. You have to do it, and then when you come up with the results, then you're ready for the filing. And so, we believe if you lead with quality, if you lead with science, and then if you lead with scale, we think that the, you know, we cover the bases.

Moderator

That's helpful. Thanks, Quintin. Maybe just on how you have High-Value Products, I think it's call it 2/3-ish, maybe a little bit less, depending on the quarter of proprietary products' revenues. From a unit, can you remind us where you are from a unit perspective on High-Value Products?

Quintin Lai
VP of Corporate Development and Investor Relations, West

So from a proprietary products, which is what we make on the primary containment and delivery side, not the contract manufacturing, it's about 40-some million components a year, and of that volume, it's about 23%-24% High-Value Products. But as a percent of sales, it's like 76%, and the reason being is that the average selling price of a standard bulk component could be in the $0.1-$0.2 a piece, and, and a High-Value Product, whether it's, as Cindy said-

Cindy Reiss-Clark
Chief Commercial Officer, West

Yeah

Quintin Lai
VP of Corporate Development and Investor Relations, West

... washed, to sterilized, to envisioned, to coated, to NovaPure, can go from $0.05 - $0.10 - $0.25 to all the way up, maybe even to above $1 a piece.

Moderator

Got it. I wasn't giving you credit for delivery devices. That's the delta between our numbers. Maybe, maybe for Chad or Quintin, just you talked about the revenue per component, margins as we move up that spectrum.

Chad Winters
Chief Accounting Officer, West

Yeah, sure. So think of the same, you know, walk that Cindy and Quintin took you up the, the spectrum. If you think of margins, standard product could be 20-25% margin. Move into a Westar RS, which is washed, Westar RU, which is ready-to-use, washed and sterilized, those are gonna be in the 40%-50% margin-ish range. And if you go all the way to the top of the house to, like, a NovaPure, you could be at 70%, 70%+ . That's the way to think of that range.

Moderator

Got it, and then, Quintin, going back to the unit mix, 23%-24%, I feel like, I don't know, last I heard maybe it was 21%, 22%, something like that. Is that shifting maybe 100 basis points, you know, 1% or 2% a year, kind of, a reasonable way to think about it?

Quintin Lai
VP of Corporate Development and Investor Relations, West

Yeah, so if you look historically, it's been about that, about 100 basis points a year. But let's look at the math. And because it's not like that, you... The what we would call mix and mix shift comes in two flavors. The first is new drugs that have been released. There are no prior volumes that are precedent, so all those incremental volumes are what we would call mix shift, and that usually comes at higher ASPs because a lot of those are biologics. So you're gonna get a nice sales bump from that mix and certainly volume. So that's gonna be new HVP volume that's coming. The other flavor is legacy products, and so every year we have some customers who move from maybe a bulk to us doing a wash or sterilize.

Some years is more than others, but the trend that we see is, we see customers moving up. They rarely decide, "Oh, you know what? We've decided to go to a cheaper product, less good product." So they all move up. So that's what drives the overall volume. It's new products and mix shift, the legacy.

Moderator

Something I wanted to tackle is restocking and destocking, and Quintin, maybe for you, and maybe we can have Cindy chime in, too. But so you moderated the guidance last quarter due to, I think, a slowdown in restocking trends from some customers. So you're expecting them to build up inventories, and maybe it didn't play out as much as you thought. But that prompted inevitable destocking concerns, which has become, well, we've lived it this year in bioprocessing. So maybe, can you just talk about what happened and what surprised you from these customers?

Quintin Lai
VP of Corporate Development and Investor Relations, West

Yeah. So, let's kind of wind back to 2020 and the pandemic. When the pandemic started, it became apparent that, first of all, people were getting sick, and there were a lot of drugs that were being used, especially in the generic side, to help people that were in the ICU. And so we prioritized them because we wanted to make sure that people were getting drugs so that they... because so many people were getting sick.

Then, as the year progressed and the vaccine manufacturers started to have success, they started to have the conversations with us, said, "West, you know, hey, looks like you need to be ready." So we then said, "Okay," we put some CapEx in flight, but we also then made plans to where we would prioritize components for vaccines, and we'd have to put everybody else on some type of allocation. And so that happened through twenty-one and twenty-two, where there were a lot of vaccines being made. Meanwhile, we had some customers who were on allocation. The products that we provided to them, they had long lead times, which then forced them to have to bring their safety stocks to levels that are very uncomfortable for them. And when I turn back over to Cindy, she can give you those stories.

So now, here we are in 2023. What we see are three kind of areas for inventory management. On COVID-19, we are seeing a destocking, and I think others in the industry are seeing a destocking. That is demand related. The demand for vaccines and boosters is a lot less than what it used to be. So therefore, those vaccine manufacturers no longer need to have so much safety stock. They can start to draw those down, and we're certainly seeing that in both our performance and our order book. Then there's another area, what we would call disposable medical devices. These things are standard products for us.

We were not capacity constrained during the pandemic, through the pandemic, and some of our larger customers probably went to the upper end of their safety stock, which is not uncommon because I think a lot of us all went to the top end of our safety stock during the pandemic, whether it be for, you know, laundry detergent or whatever. But anyway, they informed us earlier this year that they were going to start to do inventory management, and we started to see the impact of that. We saw some of it in Q3, and we expect some of it in Q4. You know, so that—we don't think that's demand related. We think it's just more of the customers managing their inventory, especially as they into, you know, we get to the end of the calendar 2023.

Then the other one is this restocking.

Moderator

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Right? Remember we had this list of companies who, you know, we had long lead time items, where they, they were having to deal with being on the lower end. Through the first nine months of this year, we were able to help them restock. Then as we got into Q4, some of those customers said they're at sufficient places and that they'll probably resume ordering next year. We knew that eventually the restocking was up, and if you take a look at our lead times, they've come down.

Moderator

Mm-hmm.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Cindy, maybe you can tell stories of like, you know, how the customers felt before and after, in terms of lead times.

Cindy Reiss-Clark
Chief Commercial Officer, West

Yeah, I can-

... Well, I think as you can imagine, you know, when you are in need of something and you can't get it, you know, there's those are very different conversations than when you're talking about potentially new opportunities and, and assurance of supply. And so what I can tell you is we recently just came back from a very large conference in Barcelona, and, you know, that is an annual conference, and a year ago, the conversations that we were having with customers was very much around, you know, "When are your lead times gonna be reduced?" and, you know, "When am I gonna be able to get my supply?" Because obviously, they've got to manage their business and manufacturing. Well, you know, fast-forward to just recently in 2023, you know, the conversations are very different.

You know, we're seeing, we're seeing the effect of our capacity coming online, and the customers are seeing the benefit of that. And so the conversations obviously were very different because now they're looking at it more as, you know, how, how do they continue to have supply chain resiliency? And so the conversations are really more around how do we leverage the West network versus, you know, how do you reduce lead time? They're really much more forward-looking.

Moderator

Got it. And then, Quintin, you know, you guys aren't guiding to 2024, but you kind of proactively said that you think you will be within your, your long-term construct of 7%-9% growth next year. Which, which seems to be kind of a preliminary indication of demand trends. How much visibility do you have into that outlook, and why would you end up above or below that range?

Quintin Lai
VP of Corporate Development and Investor Relations, West

I mean, visibility is always so—I mean, it's a combination of committed orders, conversations we have with our customers, our own internal forecast and analytics, and that's how we pull all this together. But let's kind of put it as a reminder here. Even in the fourth quarter, even though we did drop full year guidance, we still plan on growing ex- COVID-19.

Moderator

Okay

Quintin Lai
VP of Corporate Development and Investor Relations, West

... in the fourth quarter. So, again, it's not that it's not like that we're hitting a negative wall, because you, you mentioned some of the other bioprocessing customers.

Moderator

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

You know, what they're experiencing, you know, I can't really attest to since I don't know what their issues are. But what we're seeing is that we're seeing more typical growth patterns, with biologics being higher and generics and pharma being a little bit lower. That's just it is starting to fall within our construct, and, you know, that's what we're, you know, that's really as we look out to next year, you know, we expect kind of more of the same.

Moderator

Got it. Moving on to the inevitable topic. First question, is it GLP-1 or GLP-1? And two, can you talk about West's history in the diabetes space?

Cindy Reiss-Clark
Chief Commercial Officer, West

So maybe I can take that first. As Quintin said, you know, we turned 100 years old this year, and, you know, our mission during that time really hasn't changed, which I think is a pretty remarkable milestone for any company. And, you know, we have really been a critical part of the delivery of insulin really since the beginning. And, you know, obviously, diabetes and the treatment for diabetes has changed over the years, and, you know, we continue to support that evolution, including GLP-1. And, you know, I think, again, it's important to kind of recognize that GLP-1s, they're really not new, right? I mean, they've been around for some time and however, right, the new versions of GLP-1s are certainly showing some pretty impressive results in different and new treatment areas.

You know, just you know, West is committed. West is committed to support our partners as they grow and expand their business, just like we would with any, like, any indication, whether it be diabetes, new treatment areas, oncology, immunology, because, you know, we certainly want to enable the success of our clients.

Moderator

Got it. I guess a couple kind of general questions around the subject that we get asked about, to the extent you can answer some of these. I guess, when a customer orders stoppers or plungers, are these things that they order in bulk ahead of a campaign, or is it kind of like a ratable order flow? So especially maybe as we're thinking about, like, the initial launch of a therapy.

Cindy Reiss-Clark
Chief Commercial Officer, West

So if... you know, it really depends. You know, as you can imagine, that, you know, we, we work with, we have various different types of customers.

Moderator

Yeah.

Cindy Reiss-Clark
Chief Commercial Officer, West

You know, if we've got some clients that, you know, they're relying on their own internal network. They're also relying on external networks to manage that supply, and so we've got to work very closely with them to be able to onboard, you know, their partners. And that could be more intermittent or kind of more choppiness as that goes. We've got other customers that are, you know, pretty, pretty steady. You know, they've got dedicated facilities for certain drugs, and, you know, that's more level-loaded throughout the year. And so it really is gonna be dependent upon the customer and, you know, kind of the life cycle of the drug.

Moderator

Got it. That's helpful. And then, I guess, something maybe for Cindy, but Quintin, feel free to chime in: just what did you learn about capacity addition and demand planning from COVID? I'm guessing that was a very unique... It was a very unique time, and I'm guessing, Cindy, for you, it was very unique, very unique.

Cindy Reiss-Clark
Chief Commercial Officer, West

I think we all learned things that we didn't know we needed to learn during the uncertainty of the pandemic.

Moderator

Yeah.

Cindy Reiss-Clark
Chief Commercial Officer, West

You know, I would, I can start, and then I'll let you look at capacity. You know, working closely with clients, you know, just being able to understand more about how they're thinking about their business and what's required. When we were looking at the capacity investments, we wanted to ensure that we were able to put in capacity to support that ramp, but also be able to support all of our customer base. Because, you know, we support a lot of different critical treatments, and we certainly didn't want to be the reason a patient didn't get their medicine. And so it really is...

You know, our philosophy is we work very closely with our partners, and, you know, in turn with that, we make decisions to ensure that we've got the capacity around the globe where we need it and where they need it to support the different scenarios. So in that regard, it wasn't different during COVID. I think what was different was just the speed in which everybody was having to make decisions and put the capacity in the ground. But I'll let you-

Quintin Lai
VP of Corporate Development and Investor Relations, West

Yeah, and I think the level of communication and cooperation that we had with our customers and them understanding our limitations, what it takes for us to increase capacity, and understanding their, you know, when their demand's coming in, I think that's something that Cindy's teams and the supply chain team really did well with the customers. And I think that's one of the lessons that we're all of us are coming out of the pandemic, is supply chain matters.

Moderator

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

And so as we are now looking toward the future, on our proprietary side, we are building and expanding, and it's not that if we build it, it'll immediately go to 100%. In fact, that would be the wrong way to build. We're trying to build so that we have uplift capacity. Because we're always talking to customers that have something in the pipeline that they go, "West, this could be big. This could be big!" Every customer says it could be big, and then we have to be prepared for it.

Moderator

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

And if we're running at 95% capacity and some of these actually hit, then we're wrong-footed again, and everybody goes back to allocation, and then, you know, people are starting to yell again. So that's what... That is the plan, and so when you look at that, and maybe I'll hand it over to Chad to talk about some of the CapEx that we've got going on. I mean, that's what-- that's how we're trying to stay ahead of capacity.

Moderator

Yep.

Chad Winters
Chief Accounting Officer, West

You know, absolutely. And, you know, if you think of last year, it was HVP, you know, processing, and we brought in washers, and we went, and we saw the benefits of that through our lead times this year. I mean, as everyone's heard about Kinston and the plungers, for that, you know, need within the biologic space primarily. But yeah, I mean, to, to Quintin's point, looking forward, it's uplift capacity, it's mix shift conversion capacity, and it's, network flexibility-

Quintin Lai
VP of Corporate Development and Investor Relations, West

Sure

Chad Winters
Chief Accounting Officer, West

... making sure we have it at multiple HVP sites, but active projects at all of our HVP sites right now.

Moderator

That, that's helpful. Maybe I wasn't—I was gonna wait to get there, but you mentioned Kinston, and, and Quintin, you said it's just doesn't magically get filled up immediately. I, but how quickly can that facility ramp, and where does it stand right now?

Quintin Lai
VP of Corporate Development and Investor Relations, West

Well, I mean, it's ramping right now.

Chad Winters
Chief Accounting Officer, West

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

You know, there'll be even more in 2024. So again, it's trying to stay ahead, and then you know, what we try not to do is we try not to externally forecast what our customers are going to do.

Chad Winters
Chief Accounting Officer, West

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Right? Well, I mean, we, we obviously have to be prepared, but, but that, that's why we always refer and say, "Look, you need to talk to the customers of-

Chad Winters
Chief Accounting Officer, West

Yeah

Quintin Lai
VP of Corporate Development and Investor Relations, West

... what that's gonna happen. And so, but our job is to be ready. And, yeah, again, we're hoping that as we look toward, you know, early next year, we will be even more ready.

Moderator

Even more ready. Got it. Maybe I'll, I'll pause there to see if anybody in the audience has any questions.

When you move to the situations where you have to allocate, do you experience more customer loss in some way there, when you have to step down and allocate supply and versus when you're fully, everything's working great?

So the question is, when West has to allocate for customers, if capacity is tight, does that cause any issues with existing customers? Do you lose anybody? How does it impact them?

Cindy Reiss-Clark
Chief Commercial Officer, West

So for the elastomer components, it's not a common practice to have multiple formulations on a drug, just because of the nature of what you actually have to do in order to get onto the filing. And so, you know, during that allocation, that's where, you know, we are having those deep conversations to ensure that we're at least allocating enough to multiple parties to ensure that, you know, it's not disrupting their drug. So, you know, they may not have the safety levels of inventory that they would normally have, but, you know, it's just very imperative during that time that we're able to allocate to many partners, so there's not disruption to the drug on the market.

Moderator

Just a couple other follow-ups on the topic, kind of generally. Just how does participation rate change for small versus larger indication therapies? For larger therapy, is there, do you, you know, is it more likely for there to be another supplier or, you know, you not get a 100% share? I'm just curious.

Cindy Reiss-Clark
Chief Commercial Officer, West

So maybe I can answer this kind of in the two parts of our business. When you think about the proprietary business on the elastomer side, you know, as I stated, it's just not common practice to have multiple formulations on a drug.

Moderator

Yep.

Cindy Reiss-Clark
Chief Commercial Officer, West

So really, there it is about the scale. It's about the flexibility of the network and being able to assure that supply. You know, when we think about our contract manufacturing business, however, when we're making the device and, you know, doing the injection molding and assembly, that is where it's very common practice to have multiple suppliers to be able to assure the supply of the device.

Moderator

Got it. Then, kind of a higher level question. Cindy, you mentioned, you know, talking to customers about leveraging the network.

Cindy Reiss-Clark
Chief Commercial Officer, West

Mm-hmm.

Moderator

How important is it to have kind of these multiple sites producing the same product for customers?

Cindy Reiss-Clark
Chief Commercial Officer, West

So I think, you know, as you can imagine, I think everybody, it's top of mind, supply chain resiliency, and I think that's not just within the healthcare industry. I think that's every industry, right? And so the conversation that we have is, you know, when you think about, like, what's most important to our customers, it is, it's assurance of supply and quality and regulatory compliance, right? Those are the two basic things. And so when you look at the robustness of a supply chain, you know, we're looking at if a customer is single-sourced in one, only one of our manufacturing facilities, that could be risky, right?

But so we're leveraging the network because we do have multiple facilities around the globe, and, you know, it really is important to be able to flex that network, so that way we can kind of flex with their demand and ensure that we have, you know, a network that supplies the product with consistent quality regardless of where you get it.

Quintin Lai
VP of Corporate Development and Investor Relations, West

This is a, you know, this industry has kind of grown up, and we've grown up with the industry, and we've grown up with the regulators. We were there before the regulators even existed, and then we, then after they existed, we've all grown up. One of the hallmarks before in prior years is that, when a drug company spec'd in a component, it was very specific. It was elastomer, it was processing, it was dimension, it was site. Not just company specific, site specific.

Moderator

Mm-hmm.

Quintin Lai
VP of Corporate Development and Investor Relations, West

So there's still lots and lots of drugs that have that type of specification. What we have been doing, and this is a... It's gonna be a multi-year process, it's already been a multi-year process. By moving from a regional operations to a global operations network like we did eight years ago, that was the first step, right? To say: We're gonna go down this path. Then we started to say: As we upgrade and put in new capacity around the network, we're gonna do it on a standardized fashion, and we're gonna create a new class, so something that is not site specific, but more process specific.

Moderator

Yeah

Quintin Lai
VP of Corporate Development and Investor Relations, West

... so that you can now just take it from wherever, and that's our Westar Select brand.

Moderator

Mm-hmm.

Quintin Lai
VP of Corporate Development and Investor Relations, West

That is a process that is going on, and we're seeing more and more embracing of that. Now, today, we still have lots of legacy customers that are very tightly spec'd in, and but, you know, we think that, like I said earlier, they'll move-

Moderator

Yep

Quintin Lai
VP of Corporate Development and Investor Relations, West

... and they'll move. The, we're not seeing anybody going, "Hey, we like having the global network. We want to go back to being, you know, site specific.

Moderator

Yeah.

Quintin Lai
VP of Corporate Development and Investor Relations, West

No one goes backwards. That's what we're trying to say here. But people can move forward, and sometimes it just takes a while.

Moderator

Got it. Kind of pivoting to a different topic, drug delivery devices. You've seen some really strong growth there this year. I think that may be related to some commercial approvals, but could you unpack that a bit?

Cindy Reiss-Clark
Chief Commercial Officer, West

Do you want to take that?

Quintin Lai
VP of Corporate Development and Investor Relations, West

Sure. Yeah, so first of all, in our delivery devices, it kind of spans various things. We've got admin systems. Those are the transfer devices that if you have a lyophilized drug, freeze-dried drug, you can have a transfer device to be able to add saline and avoid having any kind of finger sticks. We have Crystal Zenith, which is an alternative to glass, and is really good for places where glass is suspect, and whether it be breakage, silicone oil, et cetera. And so we make cartridges and syringes and valves. That's had some good growth. And then on the delivery device side, we have SelfDose, which is a self-powered auto-injector, and then we have SmartDose, a wearable device. And last year we had three commercial approvals.

So when you look at it in totality, we don't give breakdowns of, but we're seeing growth in all of those categories here this year.

Moderator

Got it. Is there any way to think about margin across those categories?

Chad Winters
Chief Accounting Officer, West

Yeah, it varies, but... I mean, as Quintin Lai laid out there, right? I mean, different levels of maturity of those products-

... levels of volumes, obviously. So, you know, we see them continuing to move up that HVP margin curve that I talked about earlier. So, you know, as our volumes grow, we'll see that margin improvement follow.

Moderator

Got it. All right, we've got about 10 minutes or so. Contract manufacturing... Oh, sorry, question.

Speaker 5

Okay, Quintin, can you just remind us, or one of you, CapEx this year, and how should we think about it for next year?

Moderator

Question was on CapEx this year, and how to think about it for next year.

Chad Winters
Chief Accounting Officer, West

Well, we've said $350 for this year is our estimate, and we'll talk about next year on the February earnings call.

Speaker 5

Is it fair to say, I mean, just given the growth, that with some of these larger molecules that appear to be here serving, should require more CapEx? Or, like, what's the capacity situation for-

Moderator

So on the question, maybe, maybe I'll ask it. Similar question, maybe in a slightly different way. Can you just remind us what normal CapEx load is for you all? And then the question was, if you're seeing, given the demand trends that are out there right now, is it safe to assume that you'll probably be above the, maybe that construct next year?

Quintin Lai
VP of Corporate Development and Investor Relations, West

Jeff, thanks for the question. So as a reminder, a lot of the CapEx that we do, the projects can take up to two years to get done. So a lot of the projects that were initiated this year are probably going to be finished end of 2024 into 2025. The projects that we had for last year are probably getting finished end of this year and early into some into next year. That's kind of the way we do it. We do everything in phases.

And so if we try to look and when we take a look at our long-term construct of 7%-9% organic sales, we think that about 6%-7% of CapEx can support that, with the majority of that 6%-7% being growth CapEx, and then the balance of it being maintenance and IT. So that is our construct. If we see that there is a need, and if we get that signal from our customer base, that there's more to be had, you know, just like we've done in prior years, we are committed to putting that capital. Mm-hmm.

Moderator

So, my question is on contract manufacturing, but maybe we're talking about CapEx and capacity. I think you are adding some capacity on the contract manufacturing side. It's a business that's bounced around a little bit, but it's had a strong growth year this year. I think there's probably some belief that some of that's related to weight loss demand. So in areas you're adding capacity there, kind of what commitments or contracts do you have with customers when you're adding contract manufacturing capacity?

Quintin Lai
VP of Corporate Development and Investor Relations, West

So, let me start, and then Cindy, you can always come in.

Cindy Reiss-Clark
Chief Commercial Officer, West

Sure.

Quintin Lai
VP of Corporate Development and Investor Relations, West

But, let's not talk about any specific things.

Moderator

Yes.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Let's just talk about contract manufacturing as a business. As Cindy said, this is a case where we're doing it on behalf of the customer. We're probably one of several of the suppliers. The way those contracts work is that, you know, we have... We'll dedicate a part of a plant or a section, and the machines in there are gonna be dedicated to be making that one product. It's expected to be able to do it for multiple years, and unlike proprietary, it's not designed for a lot of uplift. It's designed to be run efficiently and at good capacity so that you can get your margin out of it. That's the... That is the math.

So the way you grow in contract manufacturing is, you add a new project in, which means maybe building a new building or an extension or this or that, and having to put equipment and validate. So there is a cycle to growth. So if you remember, two years ago, we had negative growth as we had to we were transitioning away as one customer was winding down a project. And then in Q4, we brought online a new project, and we saw growth, and we're about to anniversary it here in this quarter. So, whereas we had double-digit growth here, Q1, Q2, Q3, as we anniversary, be high single digit growth. That's just the math in it all.

Moderator

Yep.

Quintin Lai
VP of Corporate Development and Investor Relations, West

We have projects in flight. Nothing to mention here, nothing to talk about. But our seven to nine presumes no major projects-

Moderator

Yep

Quintin Lai
VP of Corporate Development and Investor Relations, West

... next year.

Speaker 5

Just to follow up, did that capacity that was brought online during 2020 for a specific customer? Has most of that been used, or have you been able to reallocate or redeploy to other areas or other customers?

Quintin Lai
VP of Corporate Development and Investor Relations, West

Yeah, so the question was the capacity that we brought on in 2020 for a single customer? Now, so, so a lot of the capacity we're talking about there, Jeff-

Speaker 5

Yeah

Quintin Lai
VP of Corporate Development and Investor Relations, West

... is proprietary-

Speaker 5

Yeah

Quintin Lai
VP of Corporate Development and Investor Relations, West

... and it's not dedicated to a single customer. It's more fungible within our customer network.

Speaker 5

Okay.

Quintin Lai
VP of Corporate Development and Investor Relations, West

A lot of the CapEx in 2020, 2021, 2022 was on our proprietary side-

Speaker 5

Okay

Quintin Lai
VP of Corporate Development and Investor Relations, West

... in our HVP side.

Speaker 5

Yeah.

Moderator

Maybe,

Speaker 5

Can I ask, just why be in the contract manufacturing business? How does that kind of fit?

Moderator

Question is, why be in contract manufacturing?

Quintin Lai
VP of Corporate Development and Investor Relations, West

First of all, you know, there is a set of customers on the injection devices. Some of them have their own IP, they're looking for help. Some people don't have their IP, and they're looking for someone with IP to help. Either way, we can have a conversation with them.

Moderator

Correct.

Quintin Lai
VP of Corporate Development and Investor Relations, West

Either way, they're gonna most likely be a proprietary products customer of ours.

Moderator

Mm-hmm.

Quintin Lai
VP of Corporate Development and Investor Relations, West

And so there's a lot of leverage there. Anything else?

Cindy Reiss-Clark
Chief Commercial Officer, West

Well, and just something to add, I think it's also good to... You know, there's a couple of market trends that are lending itself to greater devices, right? And so when you think about some of the current molecules on the market, they're looking for life cycle management, and they see delivery devices start to be that play. In addition, you also see the trend just in healthcare overall, to manage healthcare cost, the move into more home treatment. And that's really where we're having far more discussions around devices. And so how customers think about that is, some customers have their own device development teams, that they're developing their own devices, and they want to partner with somebody to the manufacture of those devices. And then others are actually looking for kind of on-the-market devices.

And so we look at the offerings and the portfolio that we have, is that we can be a partner regardless of the choice of our customer. And to me, that benefits the relationship as well as to be able to provide that type of service.

Moderator

With that, I think we've hit our time. So, Cindy, thank you so much for being here, Chad and Quintin as well. Really enjoyed the conversation and-

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