Thank you for joining us. I'm Patrick Donnelly, the Tools and Diagnostics Analyst here at Citi. Happy to have Bob McMahon from West with us today. And everyone, thank you for being here. So Bob, maybe just to start, high level, you've been there six months-ish?
Four.
Four?
Four.
Okay. Maybe just your initial kind of views coming into West. I know we chatted at the beginning, felt like there was a big margin opportunity, not only the mixed stuff, but maybe some other low-hanging fruit. But maybe just your initial take after four months here in the seat and the opportunity ahead.
Yeah. Thanks, Patrick. It is a pleasure to be here, and I couldn't be more excited to be part of the West team. Eric Green, the CEO, my boss, and the rest of the kind of leadership team. It's a really exciting time to be at West, and as you said, I've been here for a little over four months now.
I had a chance to tour many of the facilities, talk to a lot of customers, as well as our employees. I've come away even more excited about the opportunities in a couple of areas, and as I think about kind of the opportunities that are in front of us, we have a great business. We've got great market share in an industry that has very nice tailwinds behind it in the injectable medicines area where we are clearly the market leader.
But that being said, I know we can do a lot better. We can do a lot better in terms of operational improvements, being able to drive more growth faster, as well as, as you mentioned, on the margin side. And after four months, I'm actually even more excited about some of the things that I'm seeing that the team is undertaking and that we can undertake together to drive even more profitability and improvements going forward. And I'm sure we can talk a little bit about some of those things. But we enter here in Q4 with some nice momentum coming out of Q2 and Q3 and are excited about that continuing into 2026.
Yep. Yeah, and I know we've known each other a long time. I mean, do you think when you took your guidance philosophy, I think we joked you trademarked the word prudence that came with you from Agilent? Has that changed at all in terms of how you approached both 4Q? And then obviously, we'll talk '26 a little later, but even with the 4Q guide, I think the margins are down sequentially, which we can dive into, but how has your guidance philosophy changed, if at all, and how you're approaching things with that?
Yeah. You know, it's a great question. Yeah, I can't change my spots, Patrick. So I would say that that comes with it. I think we want to. It's not lost on us that we need to build back some credibility as well. I think we've been doing that over the last couple of quarters.
As we look at me just kind of getting a chance to get under the hood, so to speak, in terms of understanding kind of what's going on and what's driving the business, I think there's some real opportunities to further interrogate the business. We're seeing that not just looking at talking to our customers, which we do a fantastic job of, but also looking at analogs outside the and just really understanding the marketplace a little better. We're seeing that.
And we're just going through our business planning process right now. And I see a step change and hear a step change in function just around the amount of analytical rigor that we're going through. And I think that will make us a better business. It'll allow us to make better decisions, allocate capital more effectively, and then ultimately improve shareholder returns.
Yeah. And I know that's one thing when you came in, it's the visibility and the projectability of the business was something you wanted to clearly improve. And again, the execution was a little choppy before you came in. I mean, is that something that takes some time? Is there simple changes that you made? And again, where are we on that visibility journey in terms of how you're feeling about?
Yeah, I'm feeling incrementally better, but it is a journey, Patrick, as you said. I mean, I think one of the things that we're doing is we do a good job of looking at internal data and, as I mentioned, talking to our customers. But one of the things that we're doing right now is building out some more capabilities around looking at the marketplace, not just our market, but analogs.
An example would be bioprocessing. That's a very good, I would say, leading indicator to our products because they're upstream or downstream. And so as we think about that, we had looked at it, but more institutionalizing that, understanding the funnel, looking at kind of metrics around delivery dates and so forth. So I wouldn't say we're done yet. I don't know if we're ever done from that standpoint, but we are improving that rigor.
And I think one of the things that really got me excited about coming to the company, and I think it's underappreciated from the investment community, is something that Eric did in moving to the operating units. So we've got an operating unit Proprietary that represents 80% of the business. That's where our high-value component products are. And that's where the bulk of both revenues and profits are. And then you have contract manufacturing.
That's 20% of our business, the remaining very different from that standpoint in terms of kind of the operations and kind of how to execute. And so what that's done is actually allowed us to really focus on the uniqueness of each one of those businesses, drive accountability and faster decision-making, which I think is ultimately helping support our customers better, but also execute better from the standpoint of on a quarterly basis.
Now, one of the things that we are doing from the kind of the visibility is continuing to improve not only the internal analytics, but also the external, as I mentioned before, and as we're going through this business planning process, just scenario planning so that we can be able to react faster to changes in the marketplace if we need to, but then also have what's plan B and plan C.
Yep. Okay. Yeah, maybe we can dive in on the core business. So I mean, last quarter, you called out customer ordering patterns are normalizing, market conditions are healthy. I guess what's the confidence level, again, before you came or maybe the first quarter, there was still some of the stocking issues. Is that fully behind us, the confidence level there, and maybe just kind of an overall?
Yeah, our confidence is increasing every day when we look at kind of the ordering patterns across our various end markets. And I would say it's largely behind us and expected to be fully behind us here in this quarter. And as we think about kind of the momentum that we've seen across the three quarters of this year, we've seen increasing improvement.
And so not only looking at our own internal performance, but also looking at some of our external metrics as well. We're also hearing other companies, as we were saying before, saying that, hey, stocking is de-stocking has improved in kind of the rearview mirror, which is great for our business and moving into the momentum that we have into 2026.
Okay. And maybe quickly on delivery devices, I think that was flat. Kind of if you take out the incentive payment, maybe just talk about what you're seeing in that market. You have the SmartDose piece that seems well understood, but maybe we can talk about that a little bit too.
Yeah. Yeah. Our drug delivery device business, about 14% of the total company. As you said, it was down year on year, but flat if you take out the one-time incentive payment last year. It was sequentially consistent Q2 to Q3. There's four main pieces into that SmartDose and then three other products, Crystal Zenith, SelfDose, and then our admin systems.
And they're performing very well. We'll take SmartDose in a second because that's one of the things that we've been really working on over the course of this last year in terms of improving profitability. But those remaining parts of that business have grown year to date and have very nice margin profiles. And we are expecting that business to grow mid-single digits.
We've just added, and I'm sure we may talk about it, the Synchrony launch, a prefillable syringe opportunity that kind of fits in that area. We've kept it separate just for focus and so forth, but it's in that same genre of product opportunities and very nice margin profile and fits a nice product need for our customers, we believe.
Yep. And on SmartDose, I think you talked about all options still being on the table. Where are we on that front? And is there a way you can kind of break down the profitability of SmartDose? I know there's a little bit of a debate in the market about that.
Yeah. I will try to give you at least some flavor. Probably won't go into all the details around kind of the profitability other than to say that SmartDose is about 4% of that 14%. It's about 4 percentage points of total company sales, just to kind of give a frame for it.
And we've been on a two-pronged process. It's dilutive to the company margins. We can and need to do better from the standpoint of profitability. We have improved profitability every quarter through some real tough work that's been done on the shop floor, improving yields and waste and productivity and so forth. And we're investing right now in an automated line that's scheduled to come online in Q1 of next year, which should help a real step change in cost improvement.
And so we've got a good path in terms of that, but we're also looking at, are we the best home for that? And what I would say is I have high confidence that whichever path we choose for that business in 2026, 2026 will be a better year than 2025. I would say that ultimately we expect to make that decision fairly quickly. We are moving with a sense of urgency and hope to have a decision made before we give formal guidance early next year.
Okay. And I guess as you invest in these automated lines, what's the right way to think about as those come online, what that means to whether it's profitability or the overall business in terms of that piece?
Yeah. So the automated line is a real if you think about where we are today. We have two lines that are largely manual. We have one that's fully manual and then one semi-automated. This takes that automation to kind of full automation, so to speak.
It not only increases our capacities or our ability to manufacture and scale up, but it also reduces costs once it's fully ramped. Think about 2026 as kind of a transition year because you're ramping it up. And so we still have the automated lines. But when that would be up and, or excuse me, the manual lines, when that would be up and fully up and running, we would be able to reduce some of the manual lines.
And so if all goes as planned, what it would enable us to do is to get our profitability margins more in line with the overall high-value product components business. That's likely a 2027 line, just because of the transition time it would take to ramp that product or that product line up in 2026. But it's well on its way to improving the profitability this year as well as into next year.
Okay. We'll keep an eye out for that update. Maybe we can turn to GLPs. Surprisingly, I cover those. I guess.
I've never had this question before. I don't know what question it is, but.
Yeah. Maybe we'll start at high level and we'll work our way down to the nitty-gritty on this one. But maybe just high level frame up where you guys participate. Obviously, you have the proprietary product side. You have the contract manufacturing side on the injectables. And we can start from there.
Yeah. Maybe I'll start with the one that's probably the least question, which is the contract manufacturing. So in total, GLP-1s make up 17% of our revenues in Q3. 8% of that revenues were in our contract manufacturing, where we both make single-dose as well as multi-dose pens.
And those are well-known programs that we work with our key customers. The other 9% is part of our high-value components part, where we also provide. We have a very good participation across all the players within that marketplace. And that has been growing very nicely in line with the growth of GLP-1s. And so we have stoppers, plungers, as well as line seals. So we provide products for all the current platforms that are out in the marketplace today.
Yep. And how are you guys thinking about? Maybe we can stick to the proprietary product side. How are you thinking about the growth rate as we work our way forward the next couple of years? Obviously, the oral piece has come up a lot with the Orforglipron launch looming in Q1. How do you think about the injectables market? What are you hearing from your clients there?
Yeah. I think it's important to think about this in a couple of different ways. One is the level of penetration of these products today is still in its early innings, not only here in the U.S., but globally as well. And so we think that over the next, the rest of the decade, the penetration and access for GLP-1s will continue to grow. And so I don't think it's an either/or. It's an and from the standpoint of the adoption of orals. If you just look here in the U.S., just most recently, there have been a number of developments with the White House and the administration with both the major players lowering the cost for Medicaid and Medicare, which will increase access.
We think that that's a positive sign for not only the number of patients that could be covered under insurance that will drive volume and it will benefit West. But then also looking at the global nature of the business as well, you've got a number of products that are, I think, going to be launching here relatively soon on the generic side, which should help improve access. And we have a very high participation rate across all the major players in GLP-1s.
So I think the way we think about the oral adoption is it will take a portion of the market since it'll be a new modality, but it is a different side effect profile, different efficacy. And given where we see things over by the end of the decade, we think about 30% of the market will be oral.
When we look at kind of the number of the amount of penetration, both oral as well as injectables will continue to play an important role, and both will grow. We're expecting growth next year in our GLP-1 franchise, maybe not at the level that it is this year.
What's really exciting to see from our standpoint, I'm sure we'll talk about it, is if you look at our high-value business ex GLP, every quarter has improved. In Q3, we grew mid-single digits in HVP components ex GLP-1. Our expectation is that will continue to improve going into next year. While GLP-1s, we're not solely dependent on GLP-1 for growth. It is certainly a benefit, and I'd rather be in GLP-1s than not, but it's not the only growth driver for us.
Yeah. No, absolutely. And I guess when you think about the right way to think about your guys' business, is it injectable volumes? That's what matters most. Pricing, you guys are obviously not really sensitive to. So again, price coming down, volumes going up, presumably a very good thing for you guys.
Yeah, that's the right way to think about it. We're still a relatively small component of the price of these drugs. And so volume is the right way to think about this. Access is king for us because that will drive volume. And we play across all of the platforms, which is a good thing for us as well.
Yep. And another dynamic inside GLPs is kind of the single use versus the multi-dose. It seems like some pieces are swinging towards multi-dose. What's your view of how this is playing out? And then we can get into what it means to you guys.
Yeah. Our view is that there's room for both single use as well as multi-dose. If you think about Europe, it's largely a multi-dose format and has been for a number of years. So we're familiar with that. We actually, on our contract manufacturing side, produce some of those products, and in the U.S., it's largely single dose, but we do expect multi-dose to play a role here.
Now, we don't expect it to switch immediately. I think it will switch over time. There's some inherent benefits associated with single dose. You do have to change the formulation on a multi-dose, different preservative, different regulatory pathway, and so forth, and so we participate in both, so we see this as being a slower transition. Both will grow, and we'll participate in both of those as well.
Yep. And is there a simplistic way to think about just the economics for West when you look at multi-dose versus single use vials, injectors, whatever it may be? Is there some way you can just kind of frame up what this transition could mean if we do see it?
Yeah. It gets a little closer to discussing the economics associated with customers, which we don't do. What I can say is vials and single dose, the economics are roughly the same. The multi-dose doesn't have as many parts per dose, but there are some other elements associated with it. So I just kind of leave it at that. I don't want to give it a formula because it's not as easy as that.
Yeah. Is it as simplistic for some of these as if multi-dose is four shots, it's a quarter as much to you guys, or is that the wrong way to think about it?
I would say directionally, that's probably accurate, but it's not that formulaic.
Yeah. Okay. Understood. But again, to your point, I guess high-level GLP is still a good market to be in. Injectable is still confident in growth. And again, maybe some changes under the hood in terms of single-use versus multi-dose.
Yes. And I think if you think about we're talking about the products that are out in the marketplace today. As we think about the products that are still in the clinic, we still have a very high participation rate, not only with GLP-1s, but also non-GLP-1s as well, particularly in the biologics space, where if we look at our overall market share, it's 70%-75% in biologics or participation rate, which is the best proxy we have there. It's 90% plus.
So certainly, as more injectable biologics come out, that helps us from a standpoint of market share perspective. And then in addition, there are these new indications that are currently being investigated for GLP-1s as well as new molecules. So I think that there will continue to be opportunities for these newer modalities to come out and West to benefit from that.
Yeah. Yeah. And I guess in a similar vein to GLPs, I mean, another big growth opportunity for you guys, you mentioned biologics, biosimilars even. We had the FDA commissioner this morning kind of pushing hard to say, "Hey, we want more biosimilars, make it easier." Biologics are too small a piece of the market. Maybe talk about that opportunity for you guys, what it could mean to see some more of those get over the finish line.
Yeah. We very much agree with that kind of view. When we think about biologics, you just look at the pipeline and so forth, and anything that can help speed up the approval of biosimilars and make it easier from an access perspective or even a cost perspective, I think will benefit not only patients, but West as well.
When we think about biosimilars, it's actually in many cases almost the exact same product that the branded product has because the regulatory pathway is the same, and so from an economic perspective, we're somewhat agnostic between branded and generics once they go generics, and so we think that there is an opportunity to continue to grow that part of our business even faster as products come to market.
At the end of the day, as we were talking about, one of the things with the GLP-1s, you're seeing the lower cost to increase access. Biosimilars do the same thing across the entire portfolio. And so I think that that not only helps control costs for the healthcare, it increases access and helps benefit our business indirectly.
Yep. And then another growth driver kind of outside GLPs is the NX1 piece. Those project numbers continue to move higher. A nice shift for you. I guess what are you guys seeing there? How big of a tailwind can that be as we move forward?
Yeah. It's one of the things, and this is a growth driver that's non-GLP related. So NX1 for those is an increased regulatory requirement in Europe first, but now what we're seeing is more broad adoption of these, not necessarily through regulation, but just in terms of increased regulatory scrutiny and pharma companies wanting to kind of harmonize across wanting to harmonize across their geographies.
And so it's taking standard products or lower high-value products and providing more value-added services to them, which is very beneficial for us, but it also provides value to our customers as well because you're able to either sterilize, wash, or inspect the products before they come into the warehouse on the incoming QC side so they don't have to do as much QC and can get product out the door faster.
We're seeing this. We saw this as a, at the beginning of the year, 150 basis point tailwind to our growth. We've actually just recently upped that to 200 basis points of growth here in 2025. And we have, as you mentioned, 375 ongoing programs that are currently being tech developed with our customers. Our portfolio or pipeline of projects is even greater than that.
And so we expect this to continue to be a growth driver for multi-years. We've sized the opportunity just in Europe alone at 6 billion parts. We're in the early innings of converting that number of components. And so we think that this will really be able to be a nice mix shift going forward, and it's a win-win for us as well as our customers.
Yeah. And you mentioned obviously Europe is where it's happening. Are you seeing other countries look at this? Are you seeing biopharma companies that are multinationals kind of saying, "Hey, why don't we just fall in line with this because at some point it's going to come?" What's the right way to look at it?
Yeah, we are. We haven't seen any formal regulations, but what you're seeing is just this kind of regulation of continued regulators looking at the concept of continuous improvement, continuing to drive improvements in the manufacturing process, and a lot of this has to do with containment or contamination and sterility and those like areas, and so we are seeing increased questions and some scrutiny in places like the U.S., the FDA continuing to ask questions here, and that, I think, is helping facilitate some of the programs.
We are seeing, as you're saying, some of our customers saying, "Well, this is a European. It's good for our entire business." It also provides them with flexibility to be able to take our products and redirect them if they need to. So it gives them flexibility, and that's increasingly important, obviously, in the world of tariffs, right? As we think about giving flexibility to supply chains. While it started in Europe, it certainly isn't confined to Europe. We see this as a kind of a multi-year growth driver.
Yep. And you mentioned the contribution ticked up higher as the year goes. I mean, is that folks finishing projects earlier? Is it customers moving up the HVP curve higher? What's the right way to?
Yeah. The good news is it's a little of both. So we've been able to get projects, depending on kind of what the complexity of it is, can take anywhere from 12 to 18 months, but they can also take shorter time frames than that if it's a more simple transfer.
And so what we've seen is both projects being able to be executed a little faster, but actually more projects happening as well. And if you think about that, they don't happen all on January 1, right? They happen throughout the year. So this increase should pay dividends into 2026 as well. And so we feel good about kind of the momentum we have in that and the relationships that we have with our customers to help them along that journey as well.
Yeah. And where are you seeing in terms of the HVP curve where most of these customers are showing up? I think the range, the low end, the margins are maybe 45%, and then NovaPure at the top is 70%-80%. So obviously a great mix shift coming your way, but where are folks kind of shaken out in terms of that?
Yeah. It's really across the board. We're meeting our customers where they're asking us to meet them. And so this is a situation where we're trying to help solve their problems, solve problems together. And so you're seeing it all across that continuum. And we would expect that to continue. And the real question is how often. There may be multiple kinds of bites at the apple over time here as we continue to look for ways to continue to provide services and so forth. And so we see this as not a discrete event while it is discrete regulations. We have an opportunity to do this for several years.
Yeah. And obviously the HVP stuff, I mean, we talked about GLPs, NX1, biologics, biosimilars. I mean, any other key areas you'd call out as big growth opportunities where you look at, again, particularly that ex-GLP number in terms of some drivers?
I think if you just look at the level of investment that's happening in the R&D pipeline, it's in West's sweet spot, in the biologics, in the injectables area. And so I don't know if we'll ever see, never say never, but we're not dependent on the next GLP-1.
I think if we look at, we've got a lot of, I think, opportunities to continue to invest in our business and drive with the tailwinds that we have. Given that we are the market leader, we don't intend to cede that to anyone. We're continuing to invest not only in capacity, but also in making sure that we've got the right products for the customers when they need it. And so we're really excited about that opportunity going forward.
Yep. And then maybe sticking on the margins, that 4Q number, you are talking about a sequential step down 3Q to 4Q. It sounded like maybe some increased investments. What is the bridge there? Where are those investments going? Is it a little bit of kind of creating a more supportive base into 2026? What's the right way to think?
Yeah. So there's a couple of areas when we think about that. So obviously, we were preparing for the launch of our prefillable syringe Synchrony, which we want to get off to a good start. We're not launching that commercially until January, but getting all the product and training and efforts there and creating some momentum so that we've got a nice momentum going in. So the good news is we're not draining the tank, so to speak, to try to get into the rest of this year and building ourselves so that we've got a good start into 2026. So think about it as investments for growth as opposed to cost for cost's sake.
Yep. And then to your point on 2026.
And maybe some element of prudence.
Some prudence, yeah. In terms of 2026, you gave some initial commentary in terms of the moving pieces of the CGM exit, the drug handling piece, the SmartDose automation. I guess maybe just high-level, talk us through how you're thinking about the variables into next year and the things we should be keeping an eye on as we start to dust off the models here?
Yeah. Yeah. I think we came into the third quarter call with some nice momentum. We expect that momentum to continue here. And we talked about looking at where the street was and feeling that it was in a good place. We're still going through our budgeting process and still feel that that's the case. Now, one of the things I see is continued momentum on the biggest part of our business, the HVP business.
And so while our growth algorithm for next year isn't dependent on GLP-1s growing the same level that they are this year, we actually expect a slowdown. Now, still faster than the company, but not at the same levels of growth that we have this year. But more than making that up is actually going to be the growth of the core HVP business. And so continue to see good demand there going forward.
In terms of puts and takes, obviously, we'll have a decision here to make on the SmartDose and keep that kind of discreet on the side. But within contract manufacturing, we talked about a CGM contract that expires at the end of Q2. And that creates roughly a $40 million headwind in the back half of the year, partially offsetting that as a $20 million plus ramp for drug handling in contract manufacturing.
Now, that's throughout the course of the year. And we're actively looking to fill the remaining, call it $20 million there with a portfolio of programs that we're currently bidding on. So if we think about GLP-1s still growing, but not as fast, we don't need it to grow as fast. If it grows as fast, certainly life will be real good. Continued growth in our HVP business, and I would say standard products growing the way that it has the last couple of quarters as we move up the value chain from NX1, and then the contract manufacturing puts and takes.
Yep. And with the, I guess, CGM piece, I know there's an effort to backfill some of it. What do those conversations look like? What could that therapeutic modality look like? Would the margins be better than it used to be? Maybe just talk through the opportunities.
Yeah. I think maybe if we look at our contract manufacturing business more holistically, one of the things that we are trying to do is we recognize we've got to improve the economics there. It is a different model than the rest of the business.
And so we've been very thoughtful about what are some of the new programs that we can go after that actually help close the gap between our company average and kind of where we are today. And so that was one of the reasons we chose not to bid on the next generation CGM program because we just didn't feel like the economics were going to be there for us to be able to make the investment worth our while.
And so we're continuing to look for higher value added being more important to our customers from a wallet share perspective that will actually improve our profitability standpoint. So we have ongoing conversations with a number of customers today, our potential customers. Some are existing customers, some are new customers across a number of different modalities.
So I'd probably, without getting into too much detail, what I'd say is it's more similar to some of the newer programs that we have. We're not dependent on just one. We're looking at varying sizes of opportunities to fill it as well. And so our goal would be to be able to highlight when we are able to make some of the announcements around being able to fill that in due course.
Yep. And then the drug handling side, I had it down at $25 million-$30 million, but maybe that's a little bit of semantics. How much of that is kind of filled versus going after? And what's the right way to think about when you guys will have visibility into that number?
Yeah. So maybe to your first point, it's more semantics than anything else. We're not taking down our expectations on drug handling. If anything, we feel very good about that. I would say right now we're in the midst of qualifying the lines. We're doing some of the regulatory and on track to ramping up throughout the course of this year. The real question is how fast can we ramp it?
I think it's important to say whatever the number is this year in 2026, that's not the peak number. $20 million-$30 million is not the peak. It's much higher than that as we think about kind of the ongoing. And I think this is a real opportunity for us to be able to showcase that higher value opportunity that we're providing and maybe for the benefit in the short period of time. We make the pens today.
What drug handling is for us is we're taking the vials that are already filled, so we don't do the fill-finish, but we're taking that finished vial and putting it in to make a finished pen, and so what that requires us to do is have incremental cold storage. We have to verify that the API is in fact the right ingredient, and then we have to create lot tracking for all this and the systems associated with that.
That creates value for our customers because it should increase the speed of production because it is reducing a step, so to speak, in terms of at least shipping product back and forth, and so it should be a value to not only our customer, but also more value for us as well. So we're excited about that, and we'll see how things go.
Maybe in the last minute or so, the margin piece, again, I know is an area where you're excited about coming in. Not only do you have that mix shift, we talked obviously about the high value stuff, but you also have, again, maybe some operational improvements to make. How do you think about the potential for not only 2026, but just going forward when you look at whether it's the footprint, obviously the mix shift? What's the overall?
Yeah. I'm really excited. Obviously, the beauty of that is it's largely in our control. And so when I think about that, I'm seeing more opportunities today than I did when I came in. I thought there were some opportunities both in the near term, medium term, and long term.
So I think our opportunity to expand, not only do we have the mix shift positive, but we're not just relying on that. I think there's real cost improvements around sourcing, improving our yields and utilization of our factories, increasing automation, which will also increase the output of the capacity that we have. And then long term, looking at our footprint, is it the optimal footprint? And working with our customers to do that. So I'm more excited about opportunities in margin expansion today than I was three months ago.
All right. We'll leave it there, Bob. Thanks so much.
Great. Thanks, Patrick.
Thank you.