All right, good morning. I'm Dave Windley with Jefferies Healthcare Equity Research. I'm based in the States and cover CROs and pharma supply chain players. In this case, a sterile injectable container manufacturer supplier, West Pharmaceutical Services, is a company that I've covered for about 15 years and enjoyed it. It's a very interesting and complex business and fun to cover. Having said that, I haven't had the opportunity until today to meet Bob McMahon in person, so that's a great introduction. Very much appreciate he and John Sweeney, the company's investor relations lead, to be here at our Jefferies London conference soon into your tenure. Bob is the CFO. I didn't mention that, but recently joined West as the CFO. That leads us into, Bob, just talk about your early experience in these first few months at West. What have you seen?
Where do you think some opportunities are? Just kind of lay that out for us.
Great. Thanks, David. Good morning, everyone. It is certainly a pleasure to be here. A lot of excitement and energy in the room and in this conference. It is my first time here in London in this conference as well. I am super excited about being here at West. I have been here for a little over three months now. One of the things that drove me to West was really the strength of the core business, our core elastomer business, which we are the leading provider there. Over the last three months, I have had a chance to visit many sites, meet with folks, both customers internally and external stakeholders as well. Coming away from those meetings, I am really energized about the opportunities that are in front of us on a couple of facets. One is around the core growth recovery of the business.
I think we've seen that in the last couple of quarters, most recently here at Q3, growing 5% on an organic basis, really led by our high-value products, our HVP components, growth of 13%, which represents about 48% of the company. Just as importantly, the opportunity to really improve the operational execution of the business. Eric Green, the CEO, has brought in a number of new leaders, myself included, and moved into an operating unit structure, which has really helped us drive, I think, increasing accountability and focus. I think that really helps set the stage for not only the rest of this year, but going into the back half of this decade, driving very strong growth. Excited about the opportunities. A lot ahead of us, but looking forward to having a chat here with you, David, and continuing to dive in.
Yeah. Great. Thank you. You mentioned the HVP components business, certainly the biggest contributor to the revenue stream, very important in an area where investors are highly focused, a business that you have a lot of competitive advantages in. One of the questions that I know you've gotten that we get is the relative contribution and mix of GLP-1s in that business, the growth that you've seen there, and then by complement, the perhaps lower growth or less growth in the non-GLP-1. Maybe talk us through the balance of that business and where the relative drivers are falling for your components elastomers business.
Thanks, David. Yeah. As I mentioned, our HVP components are almost 50%, 48% of our business and grew 13%. That growth has really been driven by both GLP-1s as well as the core business. If we look at across our quarterly progression, both GLP-1s as well as the core business has continued to improve quarter on quarter. We would expect that to continue into Q4. As many of you know, we've been dealing with some production constraints in one of our facilities here in Europe. We've hired the folks that are needed. It's not a machinery constraint. It's really a labor constraint. Those folks are up and running. Those constraints are being alleviated through the second half of this year and should be continuing to drive additional production capacity in 2026.
It is good to be a leader in the GLP-1 business, but certainly that is not the only thing that is driving our growth in HVPs. Our HVP business grew mid-single digits ex-GLP-1s in Q3. The expectation is that will continue to drive recovery into Q4 in 2026.
I want to make sure I heard that last point right. Ex-GLP-1s, the remaining business grew mid-single digits.
That's correct. In Q3.
In Q3 year over year.
Yes.
Yeah. The biologics pipeline has been quite strong. Approvals of injectable drugs is a tailwind for you. You mentioned this capacity constraint. I guess I want to try to take those two things together and understand how much is the capacity constraint limiting growth in the core business?
Yeah. Yeah. So certainly, our biologics business, one of the things that is even better for West is our participation rate on biologics is even higher than our total market share. So our total market share is 70%-75% of elastomers. But on the biologics side, our participation rate is in excess of 90%. So certainly, as more biologics and injectable medicines are coming to market, that benefits West long-term. We expect and are looking to continue to drive that. As you are talking about our capacity constraints, I would say it has probably disproportionately impacted our core business just because of the number of different SKUs and so forth. We are seeing both that capacity constraint being alleviated both in GLP-1s as well as in our core business.
Is it right to think on that, that you mentioned both GLP-1s and core? Is it right to think that because of maybe not to the extreme and you were not with the business during COVID, but during COVID, supplying COVID vaccine got preferential treatment, is it right to think that GLP-1s are getting some amount of preferential supply ahead of the non-GLP-1 or the core?
Yeah. What I would say is we're trying to provide support to all our customers. Given the strong growth in GLP-1s, that has become a bigger piece. It is a fewer number of SKUs, so that certainly has helped from that standpoint, from an efficiency standpoint. I would say both of them, we're continuing to work and support our customers in providing the critical products that we are producing.
Got it. Okay. I want to come back to a point that you made about Eric adding a number of leaders the earlier part of this year, I think late last year. One of the other investor questions that we got fairly often was turnover in the senior executive, kind of probably the executive committee level of the organization. Talk about kind of the bulking up of the executive leadership team. Is that complete? Is that a stable group now?
Yeah. I think one of the most challenging things to do is always continue to look at, do we have the right leaders to take the business to the next level? I think Eric has been able to do that over the last couple of years. What he's been able to do as part of developing the operating unit structure is increase kind of the accountability, as I mentioned before, but also focus. With people bringing in folks like myself and Shane Campbell, who runs that business, we've got experience from larger companies, global experience. I think bringing in new ideas about how to run the business and not just look at things the way that they had been done in the past, but how do we actually continue to improve them? I think that the team is gelling very nicely.
I think it's a team that's really focused on the future and driving improved execution. I think we've got probably one more role to fill, which is our General Counsel, who is our current General Counsel is retiring at the end of the year, and we're recruiting for that right now. I think it's actually a real good time for me to come in because everyone else is working nicely together in driving the next chapter of growth for West.
Got it. Let's come back to GLP-1s and focus on that for a moment. The businesses, the market environment is growing rapidly. The aspirations for GLP-1s continue to be high. We recently ran an update there, and I was surprised to see that it was still $150 billion in terms of kind of peak sales expectations. One of the things that seems to be a growing talking point is around the delivery of those medicines, getting enough of that medicine into the market. What do you see in terms of a switch from single dose to multi-dose? And how would your economics vary between a single dose, say, syringe versus a multi-dose vial or cartridge?
Yeah. I think that if we look at that, first of all, maybe I'll take a step back and look at just a recent development that happened in the United States where two of the leading companies in the GLP-1 market struck an agreement with the Trump administration to increase access to a fairly large population of the U.S. We see that as just symptomatic of continued development and growth in the opportunities and in terms of increasing access and driving a continued penetration of this market, not only in the U.S., but then as we also think about worldwide. We are very optimistic about the long-term growth opportunities within GLP-1s. To your specific question, we see a platform of both self-injection or auto injectors as well as multi-dose pens. In Europe, you probably have more the multi-dose pens versus the self-injectors in the U.S.
We don't see that changing too much over time. Maybe some more going into multi-dose, but that will be a transition over time as opposed to a fast transition, just given kind of the convenience and the use of the current formats. Obviously, there is some economic, the economics are slightly different for us. We've taken that into account in terms of our long-term growth algorithm and still expect GLP-1 growth going forward. Maybe not at the level that we have here in 2025, certainly, which has been outsized growth. We do expect GLP-1s to grow faster than the overall company market throughout the rest of this decade.
Okay. Has West been participating or benefiting from the compounders' participation in this market?
Yeah. We do participate in it. That is part of the GLP-1 ecosystem, so to speak. It is a relatively small component, but growing. I would also say we also participate or expect to participate in the upcoming generics as some of those products are going generic in places like Canada, Brazil, and China as an example. That is one of the strengths of West is we are viewed as the key leader in elastomers. When we think about those products, they do come to us for not both branded, but also generic opportunities.
I think I'm glad you brought it up. The generic opportunity kind of got highlighted on the last call. Where do you see the generics specking in from a SKU standpoint? What's their preference in terms of level of quality?
Yeah. That's a great question. The biosimilars or the generics typically have the same product spec from the standpoint of GLP-1s and even biologics as the branded products. It is at a higher product, the high-value components, not a standard component, which generates the higher profitability from our standpoint. Why do they do that? They want to increase their chance and reduce the risk of their regulatory path. We're a relatively small piece of that cost. They just basically take the same packaging components that are on the branded product and transfer that into their drug master file.
Got it. Maybe a bridge question here would be, in addition to the elastomers' participation in GLP-1s, you're also seeing quite a strong push in other parts of your business, namely contract manufacturing and the molding of the device. Maybe talk about how that is growing, how diversified is that revenue stream in and of itself. I want to take you into integrated systems after that.
Okay. Sure. Yeah. So I think we're unique from that standpoint where we both have the elastomer side of the business as well as our contract manufacturing business. Our contract manufacturing business is fairly diverse, although we have a higher participation rate or penetration of GLP-1s in that business. It's roughly 40% of the total contract manufacturing and 8% of the total company. If we think about that business going forward, one of the things that we are looking at is continuing to drive efficiencies in that business and drive into higher-value contract manufacturing. Drug handling is a perfect example of that. That's where not only do we make the device, but now what we're doing is putting the active pharmaceutical ingredient that's in the cartridge into the device to produce the final finished good.
What that does is that actually helps the thesis here is that it improves the cycle time for our customers because you do not have to ship the components to somebody else and then make that final part. It also should be something that, given that we know how to make the pens and injectors, that should create higher yields as well for our customers. Something that is more profitable. We are moving up the value chain, driving profitability. Still early days there, but our goal is to be more diversified from that standpoint and being more important to our customers.
Got it. On your diversity point, you are more diversified in that you are generating revenues, you are touching the customer in multiple ways across that GLP-1 continuum.
That's correct.
The elastomer, the device, the compilation, the assembly of all of those pieces. How are you contractually protecting yourselves relative to this point? We talked about moving to multi-dose. There is oral potential approvals that we did not talk about, but another factor that can influence the growth of the GLP-1 class itself as it relates to number of containers, essentially. How are you contractually protecting yourselves across these various revenue touchpoints?
Yeah. We typically do not provide a lot of details about our contracts with customers. That being said, with contract manufacturing, typically you do have a 5-7 year contracted life. We work very closely with our customers in understanding what the capital requirements are, what the tooling requirements are from that standpoint. We do understand what the forecasts are from that standpoint. It is important to be able to do that to not only support our customers, but then also have good visibility into what the footprint looks like. I would leave it at that.
I think also, as we think about our elastomer side of our business as well, as we're trying to define kind of the capacity across our network, we work very closely with our customers to understand what their demand forecasts are because as we build out capacity, it's not something that we can do in six months. It usually takes multi-years to be able to put in an incremental capacity. We do have, I'd say, constant conversations with our customers, not just in GLP-1s, but more broadly to understand kind of what that demand is. I think one of the things that's important is while we were talking a little bit about a capacity constraint in Europe, we do have capacity available in the U.S.
As we think about some of the onshoring capabilities that are happening with our pharmaceutical partners, the ability to produce product in the U.S. is something that not only from a tariff perspective, but being close to where they manufacture product is something that they're also looking at as well. I think we have that opportunity to kind of leverage that capacity over time. One of it is through tech transfers, taking products from existing facilities and moving into other facilities, but then also driving better utilization across our network.
On that capacity optimization, how long do those tech transfers take? We should set our expectations appropriately in terms of how we rebalance this activity.
It can take 12- 18 months, depending on timing from an engineering perspective. It also requires sign-off from our customers. It is not something that we do to our customers. It is something that we work collaboratively with our customers on. It is something that we have some of those in flight already today in terms of being able to manage across our network, but it is not something that you can just move from one quarter to another. It does require planning.
Okay. I want to transition to what I'll title integrated systems, but in a loose sense. I guess the way I think about the trade-off of West in the elastomers business has this beautiful business, wide moat, high participation rate, as you said, lots of regulatory kind of protections around that. You're specked in, but there's 15. I think we learned during the pandemic that the supply chain for an injectable drug to ultimately get to us has 15 different pieces. You're kind of aspiring to be more than one of those pieces. How does West move longitudinally into those other pieces in a way that is economically competitively attractive to the beauty of the existing core business?
Yeah. That's a great question. To your point around the integrated systems, one of the things that we see, one of the reasons that we have such a strong, I'd say, competitive moat is the importance of the elastomer to the drug and the interaction thereof and the fact that we are in almost every one of these drug master files. How do we actually leverage that strength across kind of the containment continuum, so to speak? Our first is the West Synchrony integrated prefilled syringe, which we launched at CPHI in Frankfurt, soft launched, and will be commercially available in January. What this is, is really taking the elastomer, but then also adding the syringe components to it to have a fully verified kind of platform from a single supplier. You have platforms today, but they're bundled.
They'll take an elastomer from West, they'll take glass from somebody else and put it together with a syringe. What we are doing is providing a platform from a single supplier. It has a single design verification and characterization package so that the drug master file only has to point to one supplier as opposed to multiple suppliers the way it currently does today. We think that that will be a streamlined submission process for our customers. We think that that will be value-added over time. This is something that obviously has more players in it than the elastomer side. We do think that this is a way to be more important to our customers, but also we think it's going to grow over time. It's not going to be something that will be immediately hit.
We're not planning on drugs actually switching to this. It would be more on a go-forward basis.
Got it. So new drug. And on the so interesting point that you make about not a compiled solution, but a single vendor solution. And so on the elastomer, obviously, we know where that comes from. The glass piece is what? Is that Valor? Is that your Corning partnership feeding into that? Is that your Crystal Zenith material feeding into that? Where does the?
Yeah. Both of those are, Corning is a very important partner to us, as well as Crystal Zenith being a partnered product for us. It actually is Gerresheimer that is the exclusive supplier for the syringe. It's actually our specifications and detailed design, but they are the exclusive manufacturer at this time for that first product.
Okay. Got it. This sits alongside, I assume, these other initiatives continue forward?
That's correct.
Got it. Okay. While maybe not under the umbrella of specifically integrated systems, another angle to this, how do you participate more are your high-value devices. Let's talk about those a little bit, and particularly like a SmartDose. How does the desire to kind of commercialize proprietary delivery devices, be they on-body like SmartDose, how does that fit into this broader strategy of wanting to participate more?
Yeah. That's exactly what it does. It's providing unique delivery devices to our patients or to our customers and ultimately to patients. With SmartDose, that's something that is IP-owned within West, which is different than the contract manufacturing side where the IP is owned by our customers. This is another way of delivering product active pharmaceutical ingredients to customers. Obviously, with SmartDose, we've got two large pieces. We've got the 3.5 ml as well as the 10 ml. We're evaluating the options on 3.5. We're going down a cost-down journey as well as looking at whether or not we're in that best position to own that long term.
Yeah. I'll sneak in a last one here. On the SmartDose and on the automated line, you've said you're on track to kind of have that in place early 2026.
Correct.
That will need to ramp.
Yes.
I think management, maybe even before you arrived, described that that would double the productivity of SmartDose.
Yes.
How should we think about that mathematically from a margin standpoint?
Yeah. What I would say is margins in 2026 should be much better than in 2025 as that product ramps. That is a big, that will ramp over time in 2026. Exiting 2026 would be significantly better than 2025 should we choose to stay the course path, which is keeping that business.
If I remove time boundaries, doubling productivity cuts cogs in half. I mean, not for the full year.
Not for the full year. It's probably not all that way because you've got a capital piece too.
I guess what I'm wondering is, do I still need to think about raw material as staying the same and then reduce the value-add portion?
That's correct.
Okay. All right. Fine. Thank you for being here.
Thank you.
Need to try to get something specific out of you.