Bob.
Thank you. Great, great to be here.
Bob, the West earnings report seems like forever ago, but I think this is your first public venue since Q3 earnings.
That's correct.
Why don't we start off by reflecting on the Q3 results? What did you find encouraging, and where is there more work to do?
Yeah, it was a really good quarter for the company. The company grew 5% organic, which was ahead of our guidance. I'd say the real standout was our HVP component business, which is almost 50%, roughly 48% of our total business, that grew 13.3% on an organic basis. That was a real standout. With that strong growth, we had strong margins as well and overachieved our earnings per share growth and targets for the guidance. Very excited about the broad-based nature of the Q3 results. It's a continuation of what we saw in Q2, actually an acceleration of the performance. We're expecting that to continue into Q4 as well and moving into 2026.
I think from a standpoint of kind of the recovery of the business and the strong performance in the key growth areas of HVP, we feel very good about kind of where that business is going. On a longer-term basis, with my coming into the business now here for about three months, the opportunities to continue to not only grow the top line but really drive margin expansion over time, I'm very excited about the opportunities that we'll see. I'm sure we'll get to talk about some of those things during our talk.
Okay. One of the important therapeutic categories in HVP components is the GLP-1 category. The disclosure the company provides is great. It began about nine months ago, so now we can calculate GLP-1 revenue and non-GLP-1 revenue. Everyone's doing that math.
Yes.
In Q3, the non-GLP-1 revenue, best I can tell, was a low single-digit grower.
A little higher than that.
Excurrency?
Yeah, yeah.
A little higher. But can you describe your degree of confidence that that can return to a high single-digit growth rate?
Yeah, it's one of the things that, as we talked about this at the very beginning of the year, we were still in the midst of recovering from destocking. If you look at on a quarter-by-quarter basis of our high-value components business, ex-GLP-1s, it's improved every quarter. In Q3, it was roughly mid-single-digit growth on an organic basis, ex-GLP-1s. We would expect that to continue into Q4. What we're seeing is the destocking is largely behind us. We feel very good about the recovery of that business. Our participation rate, which is our rate of West products on new products that are coming to market, is still very high, particularly in biologics. It's greater than 90%, which is higher than our overall market share within the elastomers business.
Certainly, GLP-1s have been a growth driver for us for several quarters, and we expect that to continue. We are actually seeing that recovery of the non-GLP components as well, which is a nice adder.
Got it. So the mid-single digits is specifically for components, not total revenue.
That's correct.
Okay. I think I was doing the math on total revenue, which includes the contract manufacturing.
That's correct.
As well. You would expect that to return to high single-digit growth in the fourth quarter if destocking has concluded, or is it?
Yeah, what we're seeing is that we would expect that to continue to improve on a sequential basis. If we think about our guidance for the quarter, that's contemplated in that. Yes.
Okay. Another GLP-1 topic. It's very much a current event. That's the Eli Lilly Novo Nordisk announcement last week with the Trump administration. You've looked at the news. What are the thoughts from West Pharma on the implications for West?
Yeah, obviously, those are two very important customers for us. It's obviously very early days. If we think about the intent of this, it is to increase access, lower price, which will increase access. Increasing access is, we think, positive for West. It's positive for patients, but also positive for West because we think that more drug will get sold. This is an opportunity for us to continue to lean in and continue to support both of those very important customers, but also continue to grow our business.
Do you have thoughts on the oral vouchers that were included as part of that program?
Yeah.
Does that change your calculus and view on injectables versus orals?
It really doesn't. The oral products have been well telegraphed, and we were expecting them to be approved in 2026, first half of 2026. We do think that there's a role for both injectables as well as orals going forward. Given the penetration of GLP-1s in the marketplace, and this was before the lower pricing, we actually think that there's a net positive here relative to where we were thinking orals were coming in because I just think there would be more access to patients with the lower pricing. If we think about longer term, we do believe that orals will be roughly about 30% of the GLP-1 market by the end of the decade. There are various assumptions around there, anywhere from lows 10-15% up to a third. We're assuming in our calculus that it will be roughly 30%.
Given the penetration of these businesses or this business, as well as the additional indications that will come out, which will largely be on the injectable side, we do think that injectables will continue to grow throughout the decade. The pie will get bigger, and GLP-1s will grow both in injectables as well as orals.
Can you share what is the growth rate for GLP-1s that you've included in your long-term construct?
Yeah, we're working through the long-term construct. It's inclusive of, it's not added to our long-term construct. It's included in that. What I would say is we're expecting it to be faster growing than the overall long-term construct. I'll just leave it at that right now. For 2026, we are expecting the growth to slow from where it is this year, but still be very healthy and significantly above the total company.
Okay. As we talked a bit on the Q3 call, there are a lot of moving parts in the GLP-1 injectable market, or orals aside, between auto injectors, pens, vials, the different formats. Those have different implications for the amount of elastomer somebody might need per dose.
Yes.
How are you trying to incorporate all that complexity into your thinking?
Yeah, that's one of the elements that we are incorporating, certainly, as you have multi-dose injectors and so forth that requires fewer elastomers and so forth. That is one of the reasons why we think while the expansion will continue, it will not continue at the same level of growth that it is today. We are building that in the assumption around these multi-use formats or multi-platforms, as well as vials and so forth. I think the other opportunity for us is to look globally. Today, the US is the largest market, but there are opportunities in GLP-1s beyond the US and Europe. We will participate in that as well as we think about the long term over the next decade.
Is that specifically a comment on generics, or are there other thoughts?
It's both. It's both. I mean, certainly, generics are more near-term here in 2026. In Canada, there will be a generic version. We will participate there as well. We think we're in a very good position to take advantage of GLP-1s, whoever the ultimate end manufacturer is, as well as geography.
Okay. Talk to us a bit about the other drivers in biologics besides the GLP-1s.
Yeah, so if we think about our biologics business, it grew 8% in Q3. That included a incentive payment last year, a one-time incentive payment of roughly $19 million. If you took that out, it grew nice double-digit growth. If you looked at GLP-1s, GLP-1s was a little less than half of the growth in biologics from an end market perspective. What we're seeing is nice growth across that end market. If we think about where the pipeline of pharmaceutical products are, the majority of them are actually injectables. Our participation rate is higher on biologics. It's north of 90% relative to our market share overall in elastomers. As more products come out, we have a better participation rate or a better market share, so that helps drive that growth.
We're very excited about the continued not only participation on the elastomer side, but then we also have the drug delivery device opportunities there as well.
Okay. The drug delivery opportunity, meaning SmartDose or other?
SmartDose. Yes. SmartDose and our other drug delivery device products.
Understood. So are you fully settled on SmartDose's position in the portfolio at this point?
Yeah, we're still evaluating. So for the benefit of the folks on the call, SmartDose, we had talked about this at the beginning of the year that we were evaluating options, all options on the table. We have done a really nice job of taking out cost on our SmartDose 3.5, in particular, every quarter. That cost per unit has improved. We've improved the reliability, reduced the scrap costs, and taken costs out of the system. We'll continue to drive that to the benefit of West. In addition, we're also evaluating whether we're the best owners of this long term. We're moving with a sense of urgency on both of those analyses. Our goal would be to have clarity on this before we give formal guidance in 2026.
Okay. So by the Q4 call?
By the Q4 call.
Got it. I got excited for a moment and thought we had incremental disclosure on the date here. Not yet. Next time.
Next time.
Can you talk a bit about Annex 1 and the implications for your business?
Yeah, Annex 1 is a European regulation talking about contaminants and particulate. It is an opportunity for us to upgrade standard products into higher value products and providing additional value-added services, things like washing, sterilization, and automated inspection, and so forth. What we're seeing is an opportunity to upgrade standard products into higher value products. We've got 371 active programs today, active projects today that are actually in process of transitioning standard products to high value products and have accelerated the growth or the mix shift there over the last, I'd say, several quarters. We thought it was going to be a roughly 150 basis point improvement in our revenue. It's now 200 basis points. We see this as a mix shift that will not only help benefit our customers because it's a higher value product.
It's going to provide higher quality and efficacy for their products, but it's also good for us. We're still very early into kind of this, I'd say, multi-year kind of transition of products. We think there's about 6 billion components of opportunity out of the 40-plus billion that we produce on an annual basis. We are still early days in converting that 6 billion to high value.
Okay. I was trying to think about how to frame the revenue opportunity after the Q3 call. I took the 200 basis points of tailwind, turned that into a dollar figure. That was $60 million. I divided that by the number of the 370-odd projects and came up with a couple hundred K per project. Is that a useful framing at all, or is there a different way I should approach it?
Yeah. What I would say is every project is different. I think we've got enough body of work right now to say that that's a reasonable approximation going forward.
These are all development projects, correct? The real opportunity is when the conversion between standard and high value occurs.
That's correct. Yeah, that's correct. These are open projects. As they are completed and move a standard product into a higher value product, then it becomes part of our commercial run rate. Those are ongoing opportunities that have not shown up under revenues yet. They are showing up as standard products, but not yet into the higher value. The beauty of this is we are not increasing volumes necessarily. We are increasing additional services and procedures of existing business that we already have. That is what is great. It is really our opportunity to help our customers and really ours. That is a long-term, we see this as a multi-year kind of opportunity to continue to drive this.
What's the right way to convert that 6 billion unit opportunity into a dollar figure? Should I multiply them by $0.10 per unit? I know there's going to be a wide range, but what might be a useful rule of thumb?
Yeah, I think that that is a reasonable number.
0.10 .
Yeah.
Okay. And final clarification here, that $6 billion, those are just drug products sold within Europe, right? So that doesn't include any assumption that there is a standardization across geographies from your customers.
That is correct. That is product that is being produced for the European marketplace. Now, that being said, what we are starting to see is some pharma customers looking to standardize across the globe. We are seeing some opportunities where they're going to say, just to simplify their supply chain, they're going to do this for both Europe and US products. We're only taking right now that would be upside to kind of that $6 billion if that became a bigger opportunity. Certainly, the FDA, this is a European regulation. It's not a US regulation. Certainly, if the US would adopt something similar, that could also increase the number of opportunities. We're not building that into our calculus.
Okay. This is a good time to transition to the concept of mix shift overall. I think 10% of your elastomer, I'm sorry, 25% of your elastomers are high value today. Where does that go over time?
Yeah.
How quickly?
Yeah, that's a great question. To kind of frame, 25% of our volume is high value, but 75% of the revenue. It kind of just shows you the value of being able to upgrade. We haven't put out a specific target. Our goal is if you think about the pipeline of products that are coming down the pipe, they are largely high value products. That 25%, if we think about where we're disproportionately investing or plan to disproportionately invest in capacity, it is in our high value product network. We've got five centers of excellence today. What's unique about West is we've got two in the US, two in Europe, and then one in Asia. We're able to support our customers where their supply chains are.
Not only in terms of being able to support them as our products are rolling out around the world, it also eliminates or minimizes the tariff cost associated with that. Over time, our goal and expectation is that 25% will continue to grow. If we think about high-value components overall, we think of that as which is 48% of the total company. That business, we would expect to grow high single-digit, double-digit growth throughout the rest of the decade. It was probably in the low 40s, high 30s five years ago. It is at 48%, and I would expect that to continue going forward.
Okay. So accretive to the long term.
Yes, accretive to the long term. That is the beauty. I do not see it being a step change because the products that are on the market will continue to stay on the market. Certainly, we will upgrade them over time with things like the Annex 1. As new products come on the market, you will have that higher value components and participation.
Okay. Can you talk a bit about the pricing environment? I thought the price increase you achieved in Q3 was a little light versus your 2-3% construct. Hoping you could address that.
Yeah, it was a little less than two. Year to date, we're right at 2.4%. Any one quarter, depending on kind of how things are working, can change. We're still within that 2-3% construct. As I think about pricing, I do think that we have an opportunity to build on our history here of 2-3%. We're building some capabilities around price. I would not overinterpolate or interpolate one quarter here. In fact, I think there's opportunity over time to actually potentially improve that or to improve that. It's not only pricing for value and thinking about moving up, but also looking at the long tail of lower standard products as an example to actually price them to help incentivize people to move to higher value. That will happen over time.
One of the things that we're looking at is really a portfolio approach to our pricing, which is the first time rather than just a contract by contract approach. That'll roll out over the next several years as contracts come up for renewal and we're working with our customers. I feel really good about our pricing construct. I think there's probably more bias for upside than downside going forward.
You're doing a lot of work on the pricing front. I didn't appreciate that.
Yeah.
Anything to flag outside of the portfolio approach versus contract by contract?
No. It's still early days when I say that. We've got a number of new leaders in. Shane Campbell, who's running our proprietary business, has been with the company for about six months. I've been here three months. We're building some capabilities here. You get an opportunity to reset price roughly once a year in this timeframe as our customers are setting their budgets. This will be a multi-year journey of looking at opportunities. There is a lot of work being done, but I would say more of it is still ahead of us.
Okay. We've been talking a lot about your proprietary product segment. Maybe we can move on to contract manufacturing.
Sure.
What update can you offer on the discussions to replace the lost CGM revenue?
Yeah. Maybe for the benefit of the audience, we talked about this on the Q3 call. We've got a CGM business that is expected to exit at the end of the second quarter of next year, which roughly is a $40 million headwind. It's a contract that we've had for a long period of time. We announced this back in February of last year. We're in active discussions on a number of programs to replace that program. One program that we already have is drug handling, which we'll be ramping up in our Dublin facility. It's roughly $20 million-$30 million of revenue next year, which will help offset. It's not in the same space, but that is certainly one thing that doesn't show up in revenue this year, but we would expect it next year to help.
We have a number of programs that we are in proposal with to take over the space when the CGM business is exiting. We will communicate to you when we have more news. What I would say is we are not dependent on any one program right now. We are looking at either multiple programs to fill that space as well as a potential for a larger program as well. We are looking at multiple opportunities there.
Okay. Can you talk about the fit of the contract manufacturing business within the broader organization?
Yeah. I think one of the things that is interesting for us is the ability for us to provide services to customers across the injectable continuum. Certainly, we are the leader in the elastomer side. Obviously, things like CGM do not have as clean a fit. As we think about drug handling as an example, there is an opportunity to provide more value there to customers. That is one proof point of being able to move down the continuum of not just elastomers, but primary containment and its higher margin business within CGM or, excuse me, within our contract manufacturing business and so forth. That is kind of the idea of being able to be more relevant to our customers across that continuum. We have got to prove that though in terms of having more than just one opportunity.
That drug handling, as an example, was not a strategic element that we did. Our customers were asking us to do that. So they actually see the value of us being able to provide more services to them. Those are some of the areas of how it would link, just being more relevant or a bigger wallet share of our customers across both elastomers and contract manufacturing.
Okay. To be determined if you can scale that example to other customers.
That's our intent is to move up that value chain where we would have lower value or just injected, molded assembly, but providing higher value capabilities, which would also be higher margin for us as well.
All right. Let's move on to the margin front. Can you rank order the different margin levers you have between mix, which we've talked about a lot, and any other opportunities you have in the pipeline to improve the margin profile of West?
Yeah. I would say certainly, if we think about margin improvement, mix and price are obviously the biggest drivers here that we're already on the journey. I think we can look to are there ways to accelerate both of those elements. Even outside of that, if I think about the opportunities to kind of leverage the level of investment that we've made in our capital and capacity, we're talking about tech transfers to be able to kind of level load or more effectively load our facilities. That's an opportunity to really help our customers too so that they have products in multiple locations as they ramp up. That helps build out existing capacity or fill existing capacity without incremental or significant incremental revenue or, excuse me, CapEx. That incremental cost is much lower than building out. There's an opportunity from that standpoint.
If I think about longer term, it's how do we actually get more productive on our gross margin side? We're looking at optimization. How do we drive better yields and efficiencies through the plants and then also optimizing our network longer term? We think about kind of logistics. How do we get products shipped around the world? I think there's opportunities there to better look at ways of shipping products around and lowering our costs. I think about cost improvements as kind of near-term pricing and the HVP upgrades. Medium term is also pricing mechanisms and then longer-term network optimization.
I would say that we've got a series of actions that we're putting in place today that makes me feel comfortable that we will be able to continue to expand our margins at 100 basis points at least for the next to the end of the decade.
Okay. Is that tech transfer and network optimization you mentioned, is that related to the reshoring headlines we're reading about?
It is. Yeah. It's certainly helping that. As products and manufacturing is coming back to the U.S., we've got, particularly for our high-value products, we've got two of those centers of excellence here in the U.S. that were built out largely for the COVID timeframe that we can then transfer products that are being produced in Europe today into the U.S. as they're bringing products back into the U.S. There is a nice synergy there for our customers.
Okay. Shifting, Bob, to balance sheet priorities. You have a good looking balance sheet. What are the thoughts around that?
Yeah. It's one of the areas that when Eric and I were talking about me coming on board, I think we can do a better job of allocating our capital. I was talking to the board of directors two or three weeks ago about being more deliberate about our capital allocation. I think we've done a good job of continuing to invest in CapEx. I don't think we've done as good a job of making sure that we've over-invested or not over-invested, but disproportionately invested in our highest growth opportunities. I think we'll be more deliberate about how to think about our capital CapEx spending. More importantly, with the excess cash, how do we think about that relative to either deploying that back to shareholders or, more importantly, I think deploying it for growth?
We have not been a company that has invested a lot in M&A. I think there's an opportunity to look at technologies as well as potentially adjacencies to kind of leverage our strength in the elastomer side of the business and leverage our strong balance sheet to bring in new technologies to the company over time.
What would be strategically interesting to West?
I probably won't go into a whole lot, but what I would say is if we think about kind of where we play, we're a central and a very important component into the injectable medicines business. We think there's a number of different ways that we can play to expand our wallet share as well as our importance to customers. An example of this just real quickly, which is an organic one, is the launch of our prefillable syringe, our Synchrony S1 that we just kind of rolled out at CPHI in Germany last year and will be commercially available in January. This is an opportunity where we take the elastomer and the rest of the syringe and not just bundle it together, but it is all put together so that there is a it's kind of a single component that's reliable.
It's tested from a clinical perspective so that they know that the product interaction is defined as opposed to trying to put all these pieces together. Only West can do that, we believe, because the most important piece there is the elastomer. These would be types of opportunities to actually not only provide new products, but also look at opportunities down the road.
That's a perfect segue. My next question was on Synchrony. I know you were in Frankfurt. My European colleagues covered the event. I'm curious for a bit more framing thoughts on how we should think about that opportunity for West.
Yeah. This is really, think about it as a platform. We're thinking about this as a way for us to kind of really support our customers in a much broader way of providing them with the entire components of a syringe so that they can fill it. Obviously, there are players in that marketplace today, but they buy various components. We're a player in that now. Think about this as a way to improve the quality. It's a singular quality QMS or quality system that these components are under. We think that that will improve yield and output for our customers. It's a value add that today not really anyone can provide.
Okay. How does that fit in with the work you're doing on Crystal Zenith and your relationship with Corning?
Yeah. Corning and Crystal Zenith are important businesses for us, an important partner for us. Crystal Zenith is an important business for us and it will continue to be. I think about them as adjacencies, not substitutes.
Okay. So they would have their different, each their unique product?
They have different, yeah, exactly. They have different markets that they serve.
Okay. I mean, how big this broader integrated drug delivery opportunity, how big a business could that be for West over here?
Yeah. We have not framed it. It is going to take some time because the way we are thinking about this is it is going to be opportunities for new molecules coming on board, not necessarily taking an existing molecule and transferring it to our business. As we think about kind of our long-term construct, this could be a pretty meaningful business for our proprietary business over time. We do not see this as being the only product that we are launching. There will be a series of other products that we are going to be working on in that same continuum. Very excited about this.
Okay. Maybe just to finish it off here in the two minutes, are there any visible headwinds you'd flag that would detract from your long-term construct as we think about 2026 besides the CGM revenue that you have to replace?
Yeah. We're going through the budgeting process right now. I think we've talked about a couple of, most notably, the headwind that you just talked about. I don't see any right now. That's one of the things that's exciting and one of the reasons I came to the company is to really help to chart the next phase of West's growth. Stay tuned until we give formal guidance. We're exiting the year here with momentum in our most important businesses, which is the high-value component business. It's the highest margin business as well. Certainly, we expect that to continue into next year.
Okay. So destocking will no longer be a topic?
Yeah. Based on what we are seeing today, the ordering patterns are normalized or largely normalized. That's largely behind us. We're anticipating that destocking is going to be behind us in 2026 for sure.
Okay. And the Annex 1 tailwind would?
The Annex 1 tailwind, we expect to be very consistent with what we're seeing this year as well, probably 200 basis points of continued improvement. We have some nice opportunities ahead of us.
Okay. With that, we're out of time. Bob, thank you for joining us today.
Thank you. Appreciate it.