Hi, this is Paul Knight, the analyst covering life science at KeyBanc Capital Markets. With me today is Anna Stopkowski, who's on my team as well. We'll be running some Q&A. Then we have, of course, Bob McMahon, the Chief Financial Officer of West Pharma.
Oopsie.
John Sweeney, Head of Investor Relations. That kind of hops into my first question, Bob. You know, Agilent, of course, very, very well-known firm. I've followed it since the 1999 spin, I believe, from HP. What do you like about the West business now that you've been here a little bit?
Yeah, yeah, Paul. Great. Thanks to you and Anna for having us. We really appreciate it. What I'd say is, you know, the thing that's really super exciting about West is I think it's a business model that's fairly rarely matched in the industry. And when I think about that, a business that's got a very strong market share, 70%-75% kind of market share, with even more opportunities ahead of us as we move into kind of biologics where we have even a higher participation rate, and the durability of the business long term. When we think about the competitive moat that we have, once we're specced into a product, we are on that product for the life of that product.
It's very rare that we lose a molecule, whether that be a branded molecule or even a generic molecule. The nature of the long-term secular tailwinds behind us, the strong market position and the competitive moat that we have gets me super excited about this. As I look forward, those things are still there. I think we have an opportunity to continue to drive even better execution in the marketplace and even more margin expansion now that I've been here for six months. I'm really happy to be here with the West team.
Anna, I'll let you start with some questions.
Okay. Sounds good. Thank you, John, thank you, Bob, for both joining us today. We really appreciate it, and we look forward to this conversation. I thought maybe before we jump into 2026, we could just take a look back at what we've seen this year. I feel like we saw a bunch of dynamics, including vials starting to normalize, GLP-1s accelerating, but you also had a customer loss on the contract manufacturing side. Do you think you could just level set with investors where we sit today, and how you feel entering into 2026?
Yeah. You know, 2025 was a really, I think, really an important transitional year for the company. As you look through kind of where we started the year versus where we ended, we made a tremendous amount of progress. The second half of the year, we really started seeing the momentum on a number of different fronts come through, not only on GLP-1s, but on our core business going forward. We exit 2025 with, I think, some really good momentum. You know, at the beginning of 2025, we talked about a number of things that we wanted to get through. One is destocking on our High-Value Components business. We feel like we've gone through that.
We talked about rectifying the economics around our SmartDose product. We exited this year with the announcement that we made in January, a few months ago, of transitioning that business over to AbbVie, and I think that's a win for them and a win for us. You know, we're in the midst of transitioning our contract manufacturing, the CGM business, and really ramping up our drug handling business, which will actually have better economics going forward. On a number of different fronts, I think we made very good progress throughout 2025, and we exited 2025 with a lot of momentum, exceeding expectations. Actually, demand was greater than our supply on our non-GLP-1 business.
We sit here at the start of 2026 with, I think, a really solid momentum. I'm sure we'll talk about 2026 and kinda how we think about it, but really pleased with the progress that we have. I think a lot of those things are behind us, and we're really starting to see the business shine and what it's capable of.
Absolutely.
That's really good insight on kind of what we've seen in 2025, and seems like most of those headwinds are behind us at this point. That brings us maybe to the 2026 guide. I think you guys are guiding to 5%-7% top line growth, but I think there are a couple conservative assumptions going into that guide. You mentioned the 50% GLP-1 growth in 2025. I think you're guiding to 10% in 2026. Obviously there's also the non-GLP-1 component we'll get into, but could you just walk us through your framework for setting your guidance and visibility you have today?
Yeah. Thanks, Anna. You know, it's the beginning of the year, so I'd characterize our guidance as a prudent start to year. That five to seven percent top line growth really there's a couple of components and the majority of that growth is actually gonna be coming from our non-GLP-1 business. If we think of just the midpoint of that guidance as 6%, 5 of that points are actually coming from our HVP business, which will be over 50% of the total company. Call it high single digit, low double digit growth there. To your point, we're baselining GLP-1 at 10% or 1 point of that growth. Now, that's coming off a growth of 50%.
Quite honestly, we'd be disappointed if that's all we did. That we have probably more bias to the upside, from that standpoint. We obviously also recognize there's a number of variables that are coming into play there with things like oral GLP-1s, and I'm sure we'll talk about those as well. We wanted to make sure that people understood kind of the underlying business is very healthy with the high single-digit, double-digit growth that's really driving that. When we think about that 10% oral GLP-1 growth, that's actually a much more aggressive impact of GLP-1 orals than what we're expecting. We still believe that, you know, by the end of the decade, it's roughly gonna be 30%.
Growing both injectables as well as orals, that 10% would indicate roughly 40%-50%. A more aggressive or conservative forecast from where we think the numbers are and where we're planning. We think we're well-positioned to come into the year with continued momentum and we'll see how things play out, but we like where we're starting.
Yeah, that makes total sense and I think a smart way to frame the GLP-1 outlook. You mentioned your non-GLP-1 business.
Yeah.
I think that saw strong demand in 2025. Could you walk us through some of the drivers behind. I think you're guiding to high single-digit to low double-digit non-GLP-1 growth in 2026. I know you mentioned supply versus demand situation. Are you seeing more of that capacity ramp support that demand?
It's probably a good way to kind of take a step back and look at kind of how that progressed throughout 2025 as we were talking about before. In Q1 of last year, that was down double digits. It was down slightly in Q2. Then the second half of the year, both Q3 and Q4, we were up mid-single digits. You saw that momentum throughout 2025 really show up in that non-GLP-1 business. We're forecasting high single digit to low double digit growth going into 2026. The reason that is a number of things. One is actually we are actually seeing demand stronger than supply. We saw that in Q4.
We are building additional capacity, adding more labor into our plant in Germany, in Europe. We think that will benefit us in the first half of this year. Then you think about kinda the ongoing products that are coming on market with the biologics. We exited 2025 with greater than a 90% participation rate for the products that were being approved. Then that capacity expansion is just kinda part of the story because we continue to actually be very positively you know, positively benefited by Annex 1. So at the beginning of last year, we said Annex 1 was gonna be roughly 150 basis points of our growth.
It ended up being 200 basis points, and we're expecting for another 200 basis points here in 2026. That's really taking products that are currently on the market and upgrading them to high-value products. It doesn't really add more volume, it adds more value to our customers and so forth. When we look at the order book and the momentum that we have, as well as kind of the underlying drivers around biologics, Annex 1, and then we talked about GLP-1 before, we really feel good about the ability to kind of continue that accelerated growth in 2026. You know, we talked a little bit about this throughout 2025.
You know, ordering patterns suggest that you know, that's one of the reasons we saw the demand continuing to grow. We're expecting that to continue to happen here in 2026 as well. I think we're well set up.
Do you feel like Annex 1 is now starting to hit the demand side of the equation as companies comply and transition?
Yeah, it's a good question, Paul. We are seeing what I would say is it certainly has spread beyond Europe. You know, for those who probably may be not as familiar, Annex 1, it was a regulation that required lower levels of particulate and contamination, which required kind of higher levels of Standard Products from us. We've been on this journey of upgrading kind of Standard Products to HVP products. While it was a European regulation, what we're seeing is other, you know, our customers adopting it for non-Europe uses.
I do think that it is something that is helping drive kind of overall, you know, revenues beyond just kind of that 6 billion unit opportunity that we have. We think this is a multiyear opportunity, Paul and Anna, not just a kind of a one-time, one-and-done. These are existing products, and then you add on HVP and biologics, which are typically high-value products already. You get a kind of a multiplier effect, which is pretty exciting.
I think two follow-up questions just on that Annex 1, you mentioned. You said 6 billion units.
Yeah.
I think your Standard Products or your standard components, there's 25 billion units. Could you help us understand why 6 billion's the right way to think about it?
Yeah.
Oh, sorry.
Go ahead. No, no, go ahead.
I was just gonna mention you said Annex 1 has spread outside of Europe. Is that?
Yeah
A recent trend? Is that the back half of 2025, or when did you start seeing it?
Yeah. It's exciting. Sorry I was interrupting you. I get so excited about Annex 1 that I wanted to jump right in. 'Cause I think again, this is one that we're kinda uniquely positioned given our position in the marketplace. The 6 billion, think about. Your numbers are right. The 6 billion is really only the European opportunity. The 25 would be kind of our global number of standard units. Not all of the standard units would fall under the category of Annex 1 requirements. We do have some lower regulatory barriers.
If you think about that, if you just looked at our revenue, you know, you could say that the entire population, if the U.S. would go that way, could double that opportunity. You know, we do have kind of a bigger runway. To your point around the U.S., while there's not a specific regulatory requirement for this, what we are seeing is, and we saw it throughout the course of 2025, and probably picking up through the back half, is more companies being cognizant of it.
Actually, what we're seeing is FDA, when they were going in to do audits and so forth, they were calling this out as an opportunity for improvement and observations more than they had in the past, which will help accelerate some of that opportunity in the U.S. Then if you think about kind of the other events that are happening with more of the onshoring opportunities, what you wanna have is kind of a standard process across both Europe and U.S. We see a number of things that are kinda helping create kind of a spillover effect into the U.S. Now, what could accelerate that is if in fact the FDA created a formal regulation. We haven't seen that yet.
We are seeing companies look to simplify their supply chains and have kind of one product across multiple products or manufacturing sites, which is actually very good for our business.
Seems like there's a lot of areas of upside to the Annex 1 assumptions, just given everything you've been saying with onshoring.
Yeah, we certainly think so, Anna. You know, one of the things that we've seen is that, you know, when we look at our pipeline of opportunities within this continues to grow. It's not something that's gonna happen all in one year. It really is somewhat dependent on, 'cause there are resources that are required from not only us, but our customers to be able to demonstrate equivalence with the different, you know, procedures and processes with this. It doesn't open up the Drug Master File per se, but they do need to do the appropriate level of testing and so forth. These projects can last anywhere from six to 18 months.
The nice thing about this is we believe that this is gonna be a multi-year opportunity for us as opposed to kind of a one and done opportunity.
The FDA, are you able to edit your Drug Master File and go to a higher value solution? I feel like that would probably be an easier process than vice versa. Is that an opportunity?
Yeah, it's certainly easier to upgrade than downgrade. It would be. You know, we don't see that for sure. You know, I would say, though, that you know, customers are generally hesitant to open up that Drug Master File just given, you know, particularly for something like this. What we do is we work to make sure that it's, you know, that there is a consistency between the processes and so forth so that there isn't any difference so that they don't have to do that. It's an amendment to the file as opposed to opening up the Drug Master File.
Okay.
That's kinda how that process is working. Yeah.
I just wanted to circle back on an earlier point you made about non-GLP-1 things in 2025. I think you said it was down in the first half, up mid-single digit in the back half.
Yeah.
When we look at biologics, they're growing, I think, 10.5%. What's the discrepancy between the muted first half you saw versus what we view as market growth? Is that just overspill of some destocking that was happening in one-
Well, there certainly was the remnants of destocking, and we saw that in kind of the non-GLP-1s. You know, our biologics, when you look at that aggregate, that also includes GLP-1s, and so that certainly helped drive that. We were talking about the non-GLP-1 piece here. If you looked at our HVP, you know, business in total last year, it actually grew 9%. Now, that was largely on the benefit of GLP-1s. Now what you're seeing is rather than the non-GLP-1s, which was roughly flat, maybe a little high, you know, across that, we're actually seeing that also contribute to growth, which is actually one of the things that's really exciting about 2026 and beyond.
That's great. We touched on a couple drivers. You mentioned Annex 1, but we're also seeing obviously biologics is driving growth, but biosimilars is starting to be a topic of conversation. Is that starting to show up in your revenue at all?
When we talk about biologics, we actually include biosimilars into our you know our numbers as well because they're largely the same kind of economics for us. When we talk about kind of the 90% participation rate in 2024 as well as 2025, that also includes biosimilars. When we see more of these opportunities come down the pipe, it's actually you know a big benefit for us because what we just see is kind of the volume shift from maybe a branded to a biosimilar 'cause we still have the same level of participation. The economics for us are generally the same.
You know, you don't see a biosimilar kinda downgrade to the earlier point that we were just talking about, their primary containment. They're looking for the fastest way and the least risky way to get product on market. We're still a relatively small piece of the overall COGS of that drug. What we see is a real opportunity there. You know, first across the entire biologics portfolio as some of those products do come off patent over the next several years, I think we'll continue to see traction. Then even in GLP-1s, where you're seeing outside the U.S. some opportunities for generics, that's another area where we think we have an opportunity. We've put very modest growth expectations in 2026 there.
We think that there's probably more upside than downside for the potential uptake of some of the generic GLP-1s in places like China, Brazil, Canada, et cetera.
Okay. That's very interesting, thinking about the generics opportunity. I feel like it's usually just mentioned about biosimilars, but.
Yeah
Interesting point. Then maybe my last question, on the non-GLP-1 part of your business, your core business, is high single-digit to low double-digit a good way to think about this business, growing at just in a normalized environment?
Yeah. We really do believe so. When we think about, there's a couple of things. We've obviously talked about Annex 1 at length. That's the big growth driver that we think will continue here to be able to drive just positive mix shift that will help the high value products. In addition, the number of biologics that are currently being developed or in the clinical pipeline that should benefit that as well, and then you have underlying volume demand. This high single digit, low double digit for HVP, non-GLP-1s, we're certainly guiding to that for 2026, but we think that's a good way to think about that for a longer term growth algorithm as well.
Okay. Maybe I think we've talked about the non-GLP-1 growth drivers. If we could just quickly touch on GLP-1s. How much of your outlook, I think 10% in 2026, is supported by these long-term contracts? Can these orders be canceled? Just trying to understand the structure of these contracts and how insulated you guys are.
That's a good question. I feel the underlying market demand or what I would say the customer demand, the way I would frame it is if we only did 10%, we'd be disappointed. I would say that the requests are higher than that. We have high participation for the two largest players in the market today, as there are an element of kind of take or pay or minimum volume requirements there. If there is a change by molecule or what have you, we do have the ability to continue to get revenue. What I would say is we've been
When we think about our guidance here, one of the things that we've done is said, "Okay. We understand kinda the orals are coming in." We think we've taken a very conservative or prudent approach to kind of how that is. The data that we've seen continues to support, you know, the 30% or less kind of oral penetration. It's really bringing new patients to the market as opposed to switching from injectables to orals. Certainly since the oral Wegovy has launched, we think that that will continue that way so that both will continue to grow. You think about a couple of areas. Medicaid, the pricing there, that really hasn't come into play yet.
We haven't built a whole lot more access into our numbers, so we think that there's an opportunity there. If you look at even employer pay right now, roughly only 50% of employers are covering GLP-1s for obesity. As the price comes down, it'll be more affordable to employers certainly in the US. That should increase access. Volume should be a very good benefit. We should be a beneficiary of that volume. I kinda went in probably a little longer than what you said. We do have kinda minimum floors, but I think that there's also other things that are there that would suggest that those numbers could be better than the 10%.
Yeah, that makes total sense. We just hosted a GLP-1 panel. It seems like volumes could even be higher than mid-teens. It seems like your assumptions right now, you're assuming.
We'd all be happy.
more conservative. Yeah.
When and if that happens, we will be happy to supply our customers with that incremental volume. We are planning our level loading our capacity for higher than that number. Let me just put it that way.
While we're on the topic, we have an investor question just about generics with GLP-1. Given we're seeing semaglutide rolling off, patents rolling off in India, I think in the coming weeks, and then also China and Brazil in the coming months, are you seeing any elastomer ramp up for the generic GLP-1 launches, and are you exposed to generic GLP-1?
Yeah. We do participate with them, so we have a very good participation rate with the generic companies, and we have seen some of that. If you looked at, you know, our GLP-1 business just in 2025, just for reference, 90% of it was still branded, but, you know, roughly 10% was other, you know, other than the two largest players, but that was the fastest-growing piece. Some of which, you know, a large piece of that is, in fact, preparing for the generics and so forth. We've not assumed an outsized growth there, but we are seeing, you know, the request and demand for that, and we're on those drugs for the large part, you know, in large part.
Okay. 90% was still branded in 2025. Is that where you-
In 2025
That's where you saw the most growth, or was that the non-branded?
No. The non-branded grew faster than the branded.
Okay. Interesting.
You know, we would expect that to continue. Certainly, there's an opportunity for that to continue as these products come on. You know, that is a real nice opportunity that we've really only had very modest expectations built into our numbers.
Oh, Paul, if you have-
Well, CapEx is what this year, and what is maintenance now, do you believe?
Yeah. Yeah, we've continued to, you know, we had invested over the last couple of years pretty heavily. Our CapEx forecast for 2026 is $250-$275 million. About 40% of that would be considered maintenance and 60% kind of growth CapEx. That's down from, I think we did 285 in roughly $285 million in 2025. If we think about kind of where we have capacity, our capacity constraint that we were talking about in Europe in our German plant has been labor. It hasn't been CapEx. We'll continue to invest for growth across our business with a disproportionate part towards HVP.
We're also doing these tech transfers as well, working with our customers 'cause, again, thinking about the onshoring, they want their products, you know, some of these, their supply chain closer to where they're manufacturing and so forth. We have the ability, we probably have more capacity in the U.S. than we do in Europe. Being able to work with them to transfer some of the products to the U.S. has the benefit of not only supporting our customers and lowering their tariff rates, but it also has the benefit of kinda level loading our factories even better. That's a multi-year kinda journey. We expect to still be within that kinda 6%-8% of sales framework for the next several years, Paul.
I'm guessing the customer, it takes probably what? More, somewhere around three years to bring capacity online?
Yeah. From their standpoint, yes. You know, 'cause and you know, we have a good approximation for that, not only history, but also our own CM business when we think about kinda the drug handling as an example. That's kinda back, you know, the back end. You know, our drug handling business is coming online. In fact, we're shipping commercial batches right now, but it took us a couple of years to get that plant up and running, and then, you know, we're saying that that's a $20 million opportunity here for our contract manufacturing business this year in 2026. That's not at peak. So 2027 and 2028 will even be higher than that.
It's probably gonna be, you know, at peak, 3+ times that potential. That'll take, you know, a couple of years to ramp.
Yeah. You've had some glucose monitoring contracts, obviously. They're rolling off, and one has rolled off. Or I'm assuming you're trying to fill that capacity over time, correct?
That is correct. Absolutely. Yeah. We've got a number of opportunities that we're in discussion with. Nothing to kind of announce yet, but we're actively working to kinda fill that capacity as well as, you know, continue to look for opportunities in other places as well and gain new business. You know, drug handling is a perfect example of that.
Okay. One question we get, you know, it's always a new one every other month, but it was auto-injectors versus pens.
Yeah.
I think there's been pen announcements, but our view on a pen, right, would be maybe a pen does last four weeks or a month, but that also could include the elastomer and the plunger, right? It's two components in a pen, is it not? Then-
That is correct. Yes.
What are your thoughts about this trend of pens or is it good?
Yeah. We think it has the opportunity, first of all, where we are in the GLP-1s business, it's so under-penetrated today. We expect both will grow. We don't think that this is going to be one or the other. You're absolutely right, Paul. There's two components in a multi-dose pen versus an auto-injector or a single-dose pen today. In the U.S., the auto-injectors are so ingrained. We do think that there will be some transition, but it will happen over time. It's not gonna be an immediate.
As we expand market access, there's an opportunity for both of those things to really grow, for all the reasons that I was just talking about in terms of whether it be Medicaid, you know, employer pay, the reduction in price, and all these things, I think, have the opportunity to do that. Then I would just say the last thing, they're currently bound by capacity constraints. You know, there was a tremendous amount of capacity that was being built, sterile fill finish, as well as kinda the production capacity of the auto-injectors and pens. That installed capacity is not fungible, unlike our business with elastomers where you can move products from a. That is a auto-injector. You can't move that product to make it a multi-dose pen.
There's a multi-year kinda ramp up to just get to the capacity that we have in auto-injectors in the U.S. as well. We think that there will be multiple formats of this, and we will participate on both auto-injectors as well as multi-dose pens, and we don't think it's an either/or, it's an and.
Right. Lilly announced this $3.5 billion program.
Yes
... of X in Lehigh Valley, your backyard, basically. When do you think a company like that would start to have discussions with West about things they need from you? Is it three years before they have a facility build or one? What is the timeline, out of curiosity?
Yeah. It is, you know, for a company, we, you know, we have good discussions with them, and have good ideas of kinda what they're building in a factory like that already today. We'll have some of those discussions early on, as part of their overall kinda demand planning, and helping us make sure that we have the demand, and the capacity to help support them when their factories are coming up. You know, for us, when we do have to add new equipment, it isn't like we can just add equipment. It does take 18-36 months or 18-24 months to procure the equipment and install and validate. We do need some lead time.
Companies like Lilly are great partners for us and help us with understanding how we need to level load our factories. That just speaks to the ongoing demand of injectables, you know, around the world. We're excited to help support them on that journey.
With that, we are out of time. Really appreciate your time, John, Bob. Thank you very much.
Thank you.
Thank you, Paul. Thank you, Anna.
Thank you.
Thank you both.