West Pharmaceutical Services - Q4 2025

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the West Pharmaceutical Services Fourth Quarter 2025 Earnings Conference Call. At this time, all participants on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host for today, John Sweeney, Vice President of Investor Relations. Please go ahead.

John Sweeney (VP of Investor Relations)

Good morning, and welcome to West's Fourth Quarter and Full Year 2025 Earnings Conference Call, which is being webcast live. With me today on the call are West CEO Eric Green and CFO Bob McMahon. Earlier today, we issued our fourth quarter and full-year financial results. A copy of the press release, along with today's slide presentation containing supplemental information for your reference, has been posted in the Investors section of the company website, located at investor.westpharma.com. Later today, a replay of the webcast will also be available in the Investors section of our website. On the call, we will review our financial results and provide an update to our business and outlook for FY 2026. Statements made by management on the call and the accompanying presentation contain forward-looking statements within the meaning of U.S. Federal securities law.

These statements are based on our belief and assumptions, current expectations, estimates, and forecasts. The company's future results are influenced by many factors beyond the control of the company. Actual results could differ materially from past results as well as those expressed or implied in any forward-looking statements made here. Please refer to today's press release, as well as other disclosures made by the company, such as our 10-K and 10-Q, regarding the risks to which the company is subject. During the call, management will make reference to non-GAAP financial measures, including organic sales growth, adjusted operating profit, adjusted operating profit margin, free cash flow, and adjusted diluted EPS. Limitations and reconciliations of non-GAAP financial measures to the most comparable financial results prepared in conformity to GAAP are provided in this morning's earnings release and today's slide presentation.

I'd now like to turn the call over to our CEO, Eric Green. Eric?

Eric Green (CEO)

Thank you, John, and good morning, everyone. Thanks for joining us today. I'm pleased to report we delivered another solid quarter, with fourth quarter revenues, Adjusted EPS, and cash flow coming in above our expectations. Before I get into the details of the quarter, I would like to take a moment to reflect on what we accomplished in 2025. We returned to growth and had many notable achievements. Our performance in the year underscores the effectiveness of our growth strategy and our team's relentless focus on execution to deliver for our customers, and we enter 2026 with momentum. Our company surpassed the $3 billion mark in net sales, achieving year-over-year organic growth of over 4%. We also expanded operating margins, delivered 8% adjusted earnings per share growth, and grew our free cash flow by 70%.

Our growth was fueled by increasing demand for high-value product components as we continue to meet the evolving market and customer needs. Our growth in that business is driven by three key drivers: the rise of biologics and biosimilars, the increase in global regulatory requirements, such as Annex 1, which continue to drive HVP conversion, and the expanding GLP-1 market. These are long-term secular growth drivers that we believe West is uniquely positioned to capitalize on. We continue to address the needs of our customers through scientific support and innovation. A recent example is the launch of the West Synchrony Prefillable Syringe System. Synchrony marks a significant shift in drug delivery solutions by offering a full verified platform from a single supplier. Designed specifically for biologics, this system sets up a new standard in drug delivery by accelerating syringe selection through its comprehensive performance and regulatory data packages.

In early 2025, we announced our intention to conduct a comprehensive evaluation of the SmartDose 3.5 mL business. After our portfolio review, we announced last month the sale of the business, which aligns with our ongoing commitment to our customer development pipeline and patient-centric approach for large on-body delivery devices to drive durable and profitable growth. We expect to close this transaction mid-year. For our contract manufacturing segment, we continue to scale up operations in Dublin for drug handling, and I'm pleased to announce that just earlier this month, we commenced commercial production on this program. This remains an exciting and long-term growth opportunity for this CM business. Finally, we strengthened our executive leadership team in 2025, with five out of the 10 members having joined in the last 12 months. This seasoned leadership team is already making meaningful contributions to our organization.

With that, I'd like to turn to the fourth quarter performance. Revenues of $805 million exceeded our expectations and were up 7.5% reported and up 3.3% on an organic basis. Adjusted operating margins in the quarter were 21.4%, and Adjusted EPS of $2.04 was up 12% compared to prior year. Free cash flow in the fourth quarter was $175 million, more than double the prior year level. Let's take a closer review of each of the business segments. First, HVP components in our proprietary product segment, representing 48% of our company's total net sales, and continues to be the primary driver of revenue growth and profitability.

This business grew over 15% in the fourth quarter and was up 9% for the full year of 2025. HVP components have been tracking on a strong recovery throughout the year to align to the market demand. This business is a key differentiator for us because of our quality, scale, and technology. Once customers are spec'd into our products and reference our Drug Master File, there is a dependency there that makes it highly unlikely that customers will change partners. Growth was led by strong GLP-1 performance and continued recovery in our non-GLP-1 business. We continue to see increasing demand in this business and continue to ramp capacity. Bob will talk about our outlook in more detail, but we're expecting 2026 will have a more broad-based growth profile, driven by our non-GLP-1 HVP components, growing high single digit to low double digits.

Moving to HVP delivery devices, which represents 14% of our sales. As expected, fourth quarter revenues declined compared to prior year, driven by the incentive payment we received in the prior year quarter. However, performance was better than we expected, as we saw strong growth in Crystal Zenith and an improvement in admin systems revenue growth. Standard Products, which represents 20% of our business, declined 1.7% on an organic basis during the fourth quarter. Standard Products are an important funnel as we convert standard products to HVP components over time, which provides incremental value to our customers and generates incremental revenue and margin expansion for us. Lastly, contract manufacturing revenues increased 1.9% organically in Q4. As I mentioned, we commenced commercialization of our drug handling business at our Dublin facility, and we expect this to ramp up throughout 2026.

Our drug handling business is more profitable and less capital-intensive than the legacy contract manufacturing business. Moving into 2026, we have robust momentum as we are well positioned to advance our strategies, supported by our growth drivers of biologics, Annex 1, and GLP-1s. In biologics, inclusive of biosimilars, we continue to have great success partnering with our customers early in the pipeline, resulting in strong participation rate of greater than 90%, which is a key indicator for future HVP components revenue growth for this market. For Annex 1, we're well positioned to support our global customers' contamination control strategy and container closure integrity requirements outlined in the European regulations that were adopted in 2023. For West, this is a multiyear opportunity of currently 6 billion West components to be upgraded that support on-market injectable medicines.

I'm pleased with the progress to date, with over 700 Annex 1 projects initiated, over half of which have been completed and now generating revenues. This represents less than 15% of the 6 billion components. We completed 65 projects in Q4 of 2025, with 325 Annex 1-related projects currently underway and more in the pipeline. We anticipate these projects will drive additional revenue growth in 2026 and beyond. Now let me spend some time on oral GLP-1s and injectable formats. GLP-1s will continue to support our growth in 2026. As many of you are aware, oral GLP-1s have entered the market, and I want to share our view on their potential impact on the overall market.

To provide context, I'd encourage you to listen to publicly available remarks from the two leading companies that producing GLP-1s and their expectation that orals will expand and not substitute injectables in the marketplace. Both companies have noted that eight of ten patients using oral GLP-1s are new to the market, suggesting that orals will not cannibalize the injectables market and that several new injectables are about to launch. We expect growth from GLP-1 elastomers in 2026 and beyond for the following reasons: First and foremost, the adoption of GLP-1s is still in the early stages, with penetration of potential patient population in the low single digits by many estimates. Market access is continuing to expand, driving volume. The available clinical evidence continues to show meaningful efficacy advantages for injectables. Historically, oral formulations show higher rates of GI adverse events and treatment discontinuations than injectables....

With regard to auto-injectors and multi-dose pens, we believe that there will be multiple injectable formats based on customer preference. We expect any mix shift will happen over multiple years, given the installed capacity and investments that our customers have already made. The upcoming launch of injectable GLP-1 generics in Canada, China, India, and Brazil represents incremental business for us. In addition, there's an exciting clinical pipeline of GLP-1 molecules in development for obesity, diabetes, and other metabolic conditions. While many of these GLP-1s that are similar to what is currently on the market today, there are also newer combination molecules which potentially offer increased efficacy, improved tolerability, or therapeutic benefits for adjacent comorbidities. Finally, there are a number of exciting new GLP-1 molecules serving indications other than obesity and diabetes that are projected to come on the market over the next several years.

These include MASH, sleep apnea, chronic kidney disease, heart failure, pediatric obesity, and cardiovascular risk reduction, with five of these six indications being treated exclusively by injectables. These indications represent potential multibillion-dollar therapeutic classes. As a result, we continue to believe that both injectables and oral formats will continue to grow. Let me turn to our operations. With our strong reputation for quality, scale, and operational excellence, we're poised to capture growth from these three key drivers as we leverage our global manufacturing network. We are actively hiring and training employees who are installing and operating new equipment to optimize our European facilities and respond to strong customer demand. We utilize tech transfers to help our customers balance production across the network, enabling West to drive future growth.

We enter 2026 with momentum and are starting the year with guidance of 5%-7% organic revenue growth and 10% EPS at the midpoint of the range. Now, I'd like to turn the call over to Bob to discuss the financials and guidance in more detail. Bob?

Bob McMahon (CFO)

Thanks, Eric, and good morning, everyone. In my remarks this morning, I'll provide some additional details on Q4 revenue and take you through the income statement and some other key financial metrics. I'll then cover our full year 2026 and first quarter guidance in more detail. As Eric mentioned, we exceeded our expectations in the fourth quarter with revenues of $805 million. Q4 revenue increased 7.5% on a reported basis and grew 3.3% organically. As we mentioned last call, Q4 of 2024 included a $25 million nonrecurring incentive fee, which reduced our organic growth in the quarter by 360 basis points. So a very good result to end the year. Now, a few more details on what drove our growth in the quarter.

Our HVP components business was a standout, delivering $390 million in revenue and growing 15.1% organically. This was driven by robust growth in GLP-1s, HVP upgrades, including Annex 1, and overall continued improving performance in biologic revenues. The business outside GLP-1s continues to recover nicely, growing mid-single digits in the quarter, while demand outstripped our supply. As Eric mentioned, we continue to ramp capacity and expect stronger growth in 2026. In HVP delivery devices, revenues were $110 million in the quarter, and up $11 million on a sequential basis. The quarter was down 18.1% year-over-year organically, driven by the incentive fee in the prior year. Excluding the incentive fee, revenues would have been up slightly in the quarter.

In standard products, revenues of $162 million were down 1.7% on an organic basis, partially driven by Annex 1-related conversion to HVP components. Lastly, our contract manufacturing segment delivered $143 million in revenue, growing 1.9% on an organic basis. Segment performance in the quarter was driven by an increase in sales of self-injected devices for obesity and diabetes, partially offset by a decrease in sales of healthcare diagnostic devices. In the quarter, our CM segment revenue and profit performance was negatively impacted by a temporary production disruption due to a burst water main at our Arizona facility. The facility is back up and running, and we expect CM to return to mid to high teens profitability in Q1. Now, let's take a closer look at the rest of the P&L.

Overall gross margin was 37.8% in the quarter, up 130 basis points year-over-year. This strong result was due to the positive mix impact of HVP components growth and better-than-expected performance on our HVP delivery device business outside of SmartDose. This proof point demonstrates the earnings power of our business strategy as we continue to upgrade customers to our high-value products. Adjusted operating margins of 21.4% were down 30 basis points compared to the prior year, as we increased investment in R&D and had higher incentive compensation year-over-year. Below the line, net interest income was in line with our expectations, and our tax rate came in at 18.9% for the quarter, slightly better than expected. And we had 72.7 million diluted shares outstanding in the quarter.

Adding it all up, Q4 adjusted earnings per share were $2.04, up 12.1% versus last year, and $0.20 above the midpoint of our guidance we gave on the last earnings call. Before moving into 2026 guidance, I did want to highlight our cash flow performance. In the quarter, we delivered operating cash flow of $251 million, and our full year operating cash flow was $755 million, up 15.5% compared to the prior year. This is a very strong result and a testament to the West team. We are also continuing to drive increased efficiency in our capital spending.

Capital expenditures for the year of $286 million are down $91 million year-on-year, and we expect another step down in 2026 to a range of $250 million-$275 million as we move back to the construct of spending 6%-8% of sales in CapEx. The combination of strong operating cash flow and the lower CapEx drove free cash flow to $469 million for the year, up 70% year-on-year, and we ended the year with $791 million in cash on our balance sheet. So in summary, we had a very solid fourth quarter that exceeded our expectations, and we're entering 2026 with momentum. And now let me talk about our initial guidance for 2026.

Before getting into the numbers, I want to highlight a few important factors that help frame our thinking in setting our guidance. First, we anticipate the injectable market to continue to improve throughout 2026, driven by the underlying trends Eric talked about earlier. In addition, we've assumed the tariff landscape will remain at the current levels globally, and we have effectively covered that impact. We are assuming that we will close the SmartDose transaction mid-year. To help you with your models, we generated $55 million in SmartDose sales in the second half of 2025, and we've adjusted our full year 2026 expected organic revenue growth to account for these revenues. That said, our end markets remain dynamic, and we could see a range of outcomes, so we're being prudent with our forecasting to start the year. Now let's get into our full year guidance.

For the year, we anticipate revenue to be in the range of $3.215 billion-$3.275 billion. Reported growth is 4.6%-6.5%, and with FX and the SmartDose adjustment roughly offsetting to get to our organic growth range of 5%-7% for the year. From a segment perspective, we expect HVP components to be the primary driver of our revenue growth. We expect this segment to grow high single digit to low double digits organically for the year, accounting for just over 5 points of total company growth at the midpoint of our guidance. Given the focus of GLP-1 elastomers, we felt it would be helpful to provide some additional details on how we established our initial guidance framework.

First, we expect the non-GLP-1 HVP components to drive the majority of growth, accounting for 4 of the 5 points of growth. This is driven by continued recovery in the biologics market, where we have a very strong position. Annex 1 HVP upgrades, which we expect to deliver growth in line with 2025, ramping capacity and price. We continue to expect GLP-1s to grow in 2026, albeit at a slower pace than in 2025. To get to our midpoint, we'd expect GLP-1s to grow roughly 10% year-on-year to deliver that 1 point of growth. To put this in context, this represents a greater than 30% oral GLP-1 penetration by 2030, which is more aggressive than our current expectation.

To frame the low end of our guidance, GLP-1s would need to be flat in 2026, which we view as unlikely for all the reasons Eric talked about. It's important to note, this would free up some capacity, which would be absorbed by our non-GLP-1 business, so the impact to overall growth would not be a full point reduction. To help round out the rest of the proprietary business, we expect mid-single-digit growth in HVP delivery devices after accounting for the SmartDose divestitures and standard products to be roughly flat for the year. We also expect CM to be flat for the year as drug handling revenues of $20 million and other program growth will help offset the CGM contract that we exit starting in July of this year.

We expect to expand margins over 100 basis points, with margins increasing over the course of the year, driven by HVP components and the SmartDose divestiture. Adjusted earnings per share is forecast to be between $7.85-$8.20, representing double-digit growth at the midpoint. Lastly, a few below-the-line items to help you with your models. We are assuming roughly $10 million in net interest income, a 20.25% tax rate for the full year, and 72.7 million diluted shares outstanding for the full year. Now, moving on to our first quarter 2026 guidance. We expect first quarter revenue in the range of $770 million-$790 million. This is a reported increase of 10%-13% and an organic increase of 5%-7%.

We expect first quarter adjusted diluted earnings per share in the range of $1.65-$1.70, up 13%-16% year-on-year. We exited 2025 in a good place, and we are seeing positive momentum to start the year, driven by our key growth drivers, and we are optimistic about the future. Now, I'd like to turn the call over to Eric for some closing comments. Eric?

Eric Green (CEO)

Thank you, Bob. To summarize, the solid financial performance reported today continues to affirm that our growth strategy is working. As we build on momentum in 2026, we have a strong business which delivers unique value to our customers. We remain laser focused on our critical growth drivers. For the long term, the macro trends support less growth as a global market leader in the injectable medicine space. Finally, I want to thank our West team members for their commitment and hard work, which allowed us to achieve these strong results. Operator, we're ready to take questions. Thank you.

Operator (participant)

Ladies and gentlemen, at this time, if you'd like to ask a question, please press star one one on your touchtone telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. As a reminder, in order to accommodate all participants in the queue, please limit yourself to only one question per person. Please stand by while we compile the Q&A roster. Our first question coming from the line of Michael Ryskin with Bank of America. Your line is now open.

Michael Ryskin (Managing Director)

Great. Thanks for the question. Appreciate all the color you guys gave on, on GLP-1. That was really helpful in terms of framing it both for Q4 and, and 2026. But I want to dig into it a little bit more. You know, you end up the year on a good note. You've had sort of really steady dollar ramp in proprietary products, throughout the year. Just, you know, no real deceleration. Looking at what you talked about in terms of 10% at the midpoint of the guide for 2026, 10% growth, that seems relatively conservative given recent trends. So I'm just wondering, you know, has anything changed in your conversations in recent months with your major, GLP-1 customers, especially in proprietary products?

Is there any change in demand or tone as the orals have launched and ramped? Or just sort of, you know, anything else you could say in terms of the level of conservatism you've embedded in that? Because we could see some pretty decent upside there. If I could squeeze in a follow-up right away. Sorry, but just you know, in the prepared remarks-

Bob McMahon (CFO)

Hey, Michael. Yes. Look, do you want me? Let me jump right in. Thanks for the question.

Michael Ryskin (Managing Director)

Okay.

Bob McMahon (CFO)

I'm glad you brought that up. You're spot on. We have not seen any changes in our customer behavior. What I would characterize that is as a very conservative start to our initial guidance. We continue to believe that the adoption is going to be 30%. In order for us to achieve 10%, it would have to be greater than that, which we don't view as a likely scenario. What we're trying to show is that you know, the strength in the business is more than just GLP-1s, and that we can you know get to our guidance with a lower than expected GLP-1 number.

feel good about kind of the continued momentum that we see, not only in GLP-1s, but the rest of the business.

Michael Ryskin (Managing Director)

Awesome. Thanks. Can I squeeze in a quick follow-up?

Bob McMahon (CFO)

Sure.

Michael Ryskin (Managing Director)

Sorry. On the free cash flow, you touched on operating cash flow and free cash flow in the PR a number of times. You got strong free cash on the quarter. You've got solid cash balance. You also got the proceeds from the SmartDose coming mid-year, I think about $120 million-$130 million. Your CapEx is moderating. Are you hinting at something? Historically, we haven't really seen West do a ton of M&A, but I'm just wondering, you know, are you thinking about share buybacks, maybe doing a little bit of inorganic? Just sort of, what are you thinking there? Thanks.

Eric Green (CEO)

Yeah, Michael, good morning. This is Eric. Yeah, thanks for the question. So when you think about the opportunity, our capital deployment, our first priority, just to be clear, does not take our eye off the organic growth. It will continue to invest the business disproportionately towards our high-value product components. With that said, if there are technologies that would be of interest that we could bolt on to our existing portfolio, particularly around how we can accelerate our HVP components business while enhancing, we think about the further differentiation of our product offering to our customers, you know, that may be of interest, and it would have to be accretive, but that would be the focus in that area. And Bob, do you want to cover that?

Bob McMahon (CFO)

Yeah, just on the last piece, you know, regarding, you know, returning cash to, to shareholders, that is something that we're actively discussing. I view that as upside to our, our plan. It's one of the beauties of this business is that we've got, a tremendous cash flow business here, and, I just leave it at that.

Operator (participant)

Thank you. As a reminder, please limit yourself to only one question. Our next question coming from the line of Daniel Markowitz with Evercore ISI. Your line is now open.

Daniel Markowitz (VP)

Hey, guys. Thanks for taking my question. On the high-value components, ex GLP-1s in 4Q, it's nice to see mid-single digits. That number keeps moving in the right direction. But you mentioned that demand outstrips supply. Would you be able to give some color on what the delta was, how much the demand outstrips supply, and when you're expecting to bring on the incremental capacity to service that demand?

Eric Green (CEO)

Yeah, Daniel, let me touch on the capacity and also the demand that we're seeing build in our HVP components business outside of GLP-1. We've commented previously that we had some constraints with our operations in Europe in 2025, that we were expanding capacity, both labor and equipment. That has continued, and the demand continues to outpace our supply. As you think about the end of 2025, going into 2026, we feel really good about the order book. We feel really good about the demand that we're seeing from our biologic customers, in particular, the work that we're doing in Annex 1. So the areas outside of non-GLP-1 continues to ramp up, compared to what we saw the first part of 2025.

Bob McMahon (CFO)

Yeah, and Daniel, just to add on to what Eric is saying, we're not going to give you the details of what that gap is other than say, you know, our capacity, if I looked at what Q4 was versus Q1, it grew substantially in our European operations, but demand is growing faster. So we're continuing to add capacity beyond what our expectations were, I would say, this time last year. And so that's a good sign.

John Sweeney (VP of Investor Relations)

A final point for you there, Daniel, if you notice in our prepared remarks, we said high-value product components, excluding GLPs, are going to grow high single to low double digits in 2026. So that's part of the acceleration there.

Operator (participant)

Thank you. Our next question coming from the line of Justin Bowers with Deutsche Bank. Your line is now open.

Justin Bowers (Equity Research Analyst)

Thank you, and good morning, everyone. John, you just answered a question that I was going to get clarity on, but Eric did want to talk about some of the new GLP-1 molecules that you talked that you are seeing in the pipeline and then some of the newer diabesity GLPs as well. Are those molecules... The basic question is like, are they, are they speccing in on a different type of HVP component, i.e., like a NovaPure or a FluroTec, or just a different configuration of some of the legacy programs? And is there potential for, you know, is it a similar ASP from, you know, what you're seeing in the broader portfolio?

Eric Green (CEO)

Yeah, Justin, it depends on what part of the portfolio. There are consistency of new molecules being developed that would use similar elastomeric HVP components that we currently supply for the GLP-1 space. We also see new combination molecules that would require some barrier coating that would move it towards FluroTec, the proprietary technology that we have with our partner, Daikyo, and also NovaPure. So it is a mix, and as we see the pipeline evolve, particularly in that space, you know, there'll be more different combinations that will be used. And again, just to remind ourselves that it's not just one format. We see vial, we see prefilled syringes and cartridges, and we're in a very good position to support all modalities.

And just a step further, when we look at the other parts of the portfolio, the pipeline outside of GLP-1, it's very exciting. As I mentioned in the call, the win rate in biologics and biosimilars is consistently what we've always have seen. But it, you know, what I'm encouraged about is its broader geographies for West, and we're able to respond accordingly. So that's why it's important what Bob highlighted, is that the capacity expansion, although it's larger than it was in the early part of 2025, we still need to expand capacity to keep up what's currently in hand, but also in the pipeline.

Bob McMahon (CFO)

Yeah, and just, Justin, to add to what Eric is saying, if you think about the future fast-forward, I think it's fair to assume that the pricing today for the future will either be to what it is today or higher, given that positive mix.

Operator (participant)

Thank you. Our next question coming from the line of Paul Knight with KeyBanc, your line is now open.

Paul Knight (Managing Director and Equity Research Analyst)

Hi, congratulations on the quarter, Eric, Bob, and John. The Grand Rapids and the Dublin sites, where are they in kind of ramp-up stage? Are they at 10% utilization, 40? Can you give us some color on that?

Eric Green (CEO)

Yeah, Paul, good morning. I would characterize those two sites differently. Grand Rapids, Michigan, that's a little more mature in their, in their ramp up, so their, what we call OEE, is, is closer to what we would say is peak volumes, in, in the first part of 2026. While there's still some room and for improvement in further output, we're, we're really pleased with the progress and what they're able to deliver for our customers. In Dublin, it's, it's really two different messages there. One, we're still in the ramp-up phase of auto injectors and multi-dose pens. And as I mentioned in my prepared remarks, we just literally commenced commercial drug handling operations, which will ramp up throughout 2026, but well into 2027.

So we're excited on both fronts, and it is going to be a ramp-up phase on aggregate, I guess, over the next 12, 18, 24 months.

Bob McMahon (CFO)

Yeah, and Paul, just to add to what Eric was saying, for that, the latter piece that he was just talking about with the drug handling, we talked about it being a $20 million opportunity here in 2026. That's going to ramp throughout the course of the year, so the second half will be larger than the first half. And then it's going to be even bigger in 2027. So that certainly is not the annual opportunity for that program. It's significantly larger than that. And so we're really excited about that going forward.

Operator (participant)

Thank you. Our next question coming from the line of David Windley with Jefferies. Your line is now open.

David Windley (Managing Director)

Hi, thanks for taking my questions, or question. You, I think, exceeded our margin and maybe the street's margin expectations in proprietary products pretty nicely. Sounds like or looks like. You know, maybe mix, but utilization is probably also improving. You've commented on capacity a little bit already. I guess I wanted to understand how your tech transfer activity and, and kind of the rebalancing of capacity is progressing, you know, in the context of some comments that you've already made about, you know, demand outstripping supply, and, and comments about needing to add capacity. I guess I, I just want to understand that more comprehensively about whether, you know, demand is outstripping everywhere, or if you still have imbalance of demand, is essentially where I'm trying to get to. Thank you.

Eric Green (CEO)

Yeah, Dave. Yeah, good morning. I would just focus on the HVP components because that's what's driving the mix shift and from a margin expansion perspective. And you, you've seen this historically for West, is when we start driving HVP components close to that double digits, the mix shift effect on margins is quite pronounced, and we will continue to see that. We, our expectation is to still have a mix shift effect moving forward as we continue to drive, as I mentioned earlier, biologics, Annex 1, and even GLP-1s offers that mix shift effect for us. Our capacity, when we talk about capacity expansion, it is, it's been heavily focused in Europe, which we're alleviating as we speak.

But we're also ensuring that we're ahead of the curve in our U.S. HVP components operations, because we're seeing demand increase, frankly, in all HVP plants across the globe, which as you know, we have five of them. And so we'll continue to invest. Fortunately, at this point in time, a lot of the investments is more around labor and versus extensive capital around facilities. And then we'll drop in new equipment and extend the lines when necessary. So we're very well positioned, but we need to get ahead of the curve as Bob was mentioning earlier, the demand is outstripping supply right now, which we need to get caught up.

Bob McMahon (CFO)

Yeah, and I think it's fair to say, David, that we are looking at tech transfers throughout the course of 2026 will help alleviate some of that imbalance. We've been on that journey already, and Eric mentioned that in his prepared remarks. So it's a combination of both. And we feel like we'll be in a - we're in a better position than where we were a year ago, and in a year, we're going to be in a better position than we are right now.

Operator (participant)

Thank you. Now, next question, coming from the line of Patrick Donnelly with Citi, your line is now open.

Patrick Donnelly (Managing Director of Equity Research)

Hey, guys. Thank you for taking the questions. Bob, maybe for you on the margins, you know, it sounds like over 100 basis points expansion in 2026, which is nice to see. Can you just talk about the drivers there, the mix piece, and then maybe on the multi-dose is helpful, Eric, to hear you talk about kind of that gradual shift. What does that mean on the economic side? And again, maybe just the confidence that that is, is a gradual shift, maybe given your experience in Europe or whatever, whatever else you might be able to point to. Thank you, guys.

Bob McMahon (CFO)

Yeah. Hey, Patrick. Thanks for the question. I'll take the first one, and then I'll turn it over to you, to Eric, to talk a little bit about some of the economics. But yeah, if we talk about your math is, as usual, spot on. We're delivering over 100 basis points of margin expansion and expect to in 2026. And a large piece of that is really a result of a couple of things. One is that continued demand within the high value products components, which is driving better utilization within the plants, which is helping with our absorption, but then also the mix shift. And I would say it's a good combination of both of those.

In addition, you know, we continue to generate, you know, positive price, but I would say it's the first two. And then really one of the focuses that we've had over the last couple of years is really around the conversion through Annex 1 and the regulatory requirements. And we see that as a continual multi-year journey, as Eric mentioned earlier. And we've got a long runway in our belief to be able to upgrade some of the standard components to those HVP components, which will also help with the margin. We see some of that in here as part of that positive mix. So it's really both.

Then, you know, we're continuing to leverage our OpEx as well, kind of below the gross margin line to get to some of that, but most of it will be in gross margin. You want to talk about the,

Eric Green (CEO)

Thanks, Bob. And Patrick, in regards to the multi-dose and auto-injectors, particularly in the GLP-1 space, just to kind of frame it up real quickly, there's three different ways we look at from the elastomer point of view. One is we do support the vials with the stoppers. When you think about the auto-injectors, it's really, there's a component, but also a plunger that we provide, which is... And then in the pen system, you look at a plunger and also a line seal on the cartridge. And I would say the plungers are not equal between the two. And it is correct that multi-dose pens are approximately four doses per one single use auto-injector. There's two factors to look at when you ask about timing.

You're right to say that we have good lens on this part of the market, because our contract manufacturing business is exactly working with our customers in this space to do mass scale manufacturing of auto-injectors and multi-dose pens. What we see is, as you know, there's a higher dependency on multi-dose pens in Europe than in the United States, where the US is more single dose. So these, these are significant installed capacities that our customers invest in, into our facilities, and these are long-term commitments, and it takes multiple years to get up to ramp. As Paul asked earlier, how we're ramping in Grand Rapids and in Dublin, these are multi-year journeys to get to peak volumes. And so we do see this as a one, installed capacity investments of our customers.

Still, we don't see this as a quick shift if that would occur. And secondly, really, it's the market acceptance and patient acceptance. They're very different experiences. And so those are the two factors that we see, but we see it as a multi-year journey, particularly with the lens we have with CM and also the investment order patterns we see with our elastomer business to support it, as a primary containment.

Bob McMahon (CFO)

Yeah, Patrick, the only other thing that I would add is if we think about the future, many of the things that Eric was talking about in terms of multiple indications and new molecules are on single dose in the U.S. as well. And so that also speaks to the, I'd say, the consistency and the stickiness of the auto-injector as we see it looking forward.

Operator (participant)

Thank you. Our next question coming from the line of Matt Larew with William Blair. Your line is now open.

Matt Larew (Research Analyst)

Hi, good morning. Eric, you know, for years, you had talked about the device opportunity as something West was excited to participate in and would be potentially growth and margin accretive. And then, of course, last year, with the Smart Dose saga, I think that narrative got derailed a little bit. You know, now announcing Synchrony, I know you announced it at CPhI and sort of launched it commercially last month. But maybe give us an update on where, you know, you're excited about the device opportunity going forward. Do you still see that as a big potential opportunity for West?

And then whether, you know, the portfolio of products you have today, you think is the right one to attack that market, or if there's more either product development or inorganic growth opportunities that might help supplement the capabilities you have today?

Eric Green (CEO)

Yeah, Matt, it's a multipronged approach when you look at our proprietary business, particularly around our elastomers. So first priority is continues to look at line extensions and new formulations that are adopted in the marketplace for our customers. And as you think about the new molecules in the pipeline, they're more complex. And therefore, we, we have to continue to innovate with our customers with new formulas around the elastomers. So that, that is our primary focus when we think about R&D investments. The second area that you touched on is our the launch of West Synchrony prefillable syringe, and this, this is truly unique in the marketplace. And this stems from the elastomer business.

This is where our customers have been looking at how can West support them on full characterization to provide all the data packs that allow them to file with the FDA and simplify. Because as everyone knows, these prefilled syringes have to be approved with the drug molecule as a combination device, not as individual components. So we're basically taking that work from our customers, and we're providing the complete solution with this offering that we have with Synchrony. It's very close to our elastomer business. The economics are very attractive. What I would articulate, and it's a long-term journey, by the way. It is really pipeline. I will say that I'm very pleased with the team's recent launch.

It occurred a few weeks ago in Italy as an official launch, and we already have orders. So I'm pleased with the initial progress, but it will take time like any other new launch we had, like NovaPure and other elastomer components. But I would look at this as an extension of our HVP spectrum that we have articulated and showed graphically of how we're moving up that curve for our customers. And I would disassociate that with the drug delivery devices that we have in the other units, like SmartDose 3.5. Very different economics, very different growth profiles, and excited about where we are, but it's a long-term journey.

Operator (participant)

Thank you. Our next question coming from the line of Dan Leonard with UBS. Your line is now open.

Dan Leonard (Managing Director of Equity Research)

Thank you very much. I could just use some help clarifying the growth assumptions for HVP in 2026 and how they compare to 2025. So you mentioned that the GLP-1 growth will be 10% at the midpoint. What was that growth number in 2025? And then the non-GLP-1 HVP is high single- to low double for 2026. What was that comparable number in 2025? I just want to know what kind of a ramp upside in non-GLP-1 and what kind of conservatism in GLP-1 that we're all assuming here.

Bob McMahon (CFO)

Yeah, that's a good question. I'll give you kind of ranges. We're not going to get into the specifics, but you know, GLP-1s for the full year grew in excess of 50%. And if you looked at the non-GLP-1s, it was roughly flat. It was with mid-single-digit growth in the second half of the year. And so we're expecting acceleration on the majority of that bit, you know, the non-GLP-1 business into 2026 at kind of that mid or high single- to low double-digit growth.

Operator (participant)

Thank you. Our next question coming from the line of Brendan Smith with TD Cowen. Your line is now open.

Brendan Smith (Director and Senior Analyst)

Great. Thanks for taking the questions, guys. Actually wanted to ask a bit more about the Annex 1 cycle upgrades that you referenced. You noted, I think, that what's been completed is about 15% of the total opportunity, and in the deck, you mentioned that West has met its 2025 goals. Wondering if you could maybe speak any more granularly to West 2026 goals in this area, and I guess what really drives some of your visibility into those assumptions over the coming year, just given that I'm guessing some of those decisions are ultimately coming from the partners. Thanks.

Eric Green (CEO)

Yeah. Great, Brendan. Great question. Thank you. When you look at the Annex 1, we see this as a multiyear journey. So when I talk about the 6 billion components, just put that in perspective. In proprietary, we do about 36 billion components a year. This is a subset of the total company, of which, when you think about the HVP, it's called roughly about 10 billion of that. The delta of 35, 36, I mean, I'm sorry, 25, 26 billion is what we call standard, and a subset is 6 billion. So just to put it in context of what portion of the business from a unit volume perspective that we're speaking to, and so far to date, less than 15% of that has now been commercialized.

So a lot of the projects that rolled off, we mentioned 65 in Q4, those start—they start being commercialized throughout 2026 and beyond. So now the customers change. They're ordering from the previous product that they would procure for from West to the new product, which is now an HVP product going forward. So those revenues will start building in 2026. To summarize, we believe the continuation, about 200 basis points going into 2026, will be driven by Annex 1, and we believe that's sustainable based on the pipeline. So there will be products rolling off into commercial and new products being added, and that's what we're seeing throughout 2025, and we expect the same in 2026.

Operator (participant)

Thank you. Our next question coming from the line of Thomas DeBourcy with Nephron Research. Your line is now open.

Thomas DeBourcy (Principal and Senior Equity Research Analyst)

Hi, thanks for taking the question. Just wanted to touch on just, contract manufacturing and, I guess, refilling the demand pipeline, for the second half. I think you mentioned relatively flat growth for contract manufacturing, which reflects, you know, I guess, refilling that demand. But just wanted to see kind of the opportunities you're seeing there. And then just also on reshoring of U.S. customers, whether that's an incremental opportunity or you just support them as, you know, depending on where they want to manufacture their product. Thanks.

Eric Green (CEO)

Yeah. I'll start with the second portion first on the onshoring of customers, and it's interesting because those conversations are ongoing in 2025. When there's announcement of new investments, we're already at the table having conversations how we can support them on the supply chain. So there could be incremental volume coming from our customers due to these investments, or it could be a shift in their manufacturing strategy. The fortunate part about West is that we have the assets that are able to support them, whether it's in Europe or the United States or even in Asia, when you think about our HVP manufacturing plants. So therefore, we'll continue to add capacity to build support them, but the fortunate part is we do currently have volume in these sites. Any additional capacity would be more around labor and equipment versus new facilities.

On the contract manufacturing side, you know, you know, looking at the business that's exiting end of Q2, that space will be, our intent is to have it utilized by new customer, as we move into later part of 2026. It'll take time to ramp up, to install the new capacity, new equipment from our customers, but we're in several discussions right now, and we'll communicate once we have everything finalized. But we feel good about where we are, able to utilize that assets and build to support other customers and other products, while other investments will ramp up, particularly around the other Dublin site and also Grand Rapids, Michigan.

Operator (participant)

Thank you. Our next question in the queue coming from the line of Doug Schenkel with Wolfe Research, your line is now open.

Doug Schenkel (Managing Director)

Thank you for taking my question. You did a really nice job in your prepared remarks, talking about the outlook for GLP-1s and the impact of orals on your business. If we keep those comments in mind and ostensibly your efforts to be, you know, conservative, as you talked about, you know, the inputs in 2026 guidance and then also the longer-term framework for GLP-1s, I'm wondering if we kind of get at, you know, maybe a midterm outlook, if it's fair to say you're comfortable with your, you know, your GLP-1 framework combined with the recovery you're seeing in non-GLP-1 HVP, which of course includes the impact of Annex 1. If you're comfortable saying, as built, even in a conservative scenario for GLP-1s, that your revenue can grow at least mid- to high-single digits over the next several years.

Thank you.

Eric Green (CEO)

Yeah. Hey, Doug, thanks for the question, and the short answer is yes.

Operator (participant)

Thank you. We have a follow-up question from Daniel Markowitz with Evercore ISI. Your line is now open.

Daniel Markowitz (VP)

Hey, guys, thanks for letting me rejoin the queue and ask another one. I'm curious, just framing the Annex 1 opportunity ahead, it seems like there are reasons to be excited and, and potential for accelerating benefit to the business. Can you talk about what you're hearing in customer conversations that suggest this could be a greater area of focus for customers going forward?

Eric Green (CEO)

Yeah, no, you're absolutely correct. Engaging with our customers, there's certain events that occur, particularly with, in the supply chain, when they're having contamination control issues. This comes up during the audits and inspection by the regulatory bodies, particularly in, obviously in Europe, but also with the FDA. And while these are becoming more front and center with our customers to prevent any potential delays or stockouts of drug molecules, or frankly, Form 483s or warning letters, these conversations are becoming more active for us. And the fortunate part is we have the resources, we have the regulatory and quality organizations in place that really support our customers to make those decisions and then be able to provide a final solution with the products, such as our washing technology, Envision technology, even through sterilization.

So when we think about what we offer our customers, this is a great opportunity. And so, yes, we're heavily engaged with our customers. When they're making a decision, do they look at, can they actually handle that process internally? And most of the time, what we're seeing is, no. Let's have West take care of the expectations to meet the regulatory requirements and the quality requirements. So we believe this is a long-term opportunity, and it has multi-year impact for us, and it fits really well with our HVP component strategy.

Bob McMahon (CFO)

Hey, Dan, just to add to what Eric was saying, just a couple of things. You know, we've sized that opportunity as $6 billion or 6 billion units, excuse me. There's a potential that that could be even more as we think about things like reshoring. If you're reshoring something that is already spec'd in Europe into the U.S., that is an opportunity to automatically upgrade. And what we're hearing from customers is to or in order for them to simplify their supply chains, they don't want to have multiple components that have different specs across their network. And so, as the regulatory scrutiny continues to grow outside of Europe, there's a desire to kind of standardize across this.

So, not only do we see the opportunities that Eric was talking about, there's a potential that it could even be bigger over time, with some of these other dynamics that are in play, across the industry.

Operator (participant)

Thank you. Ladies and gentlemen, that's all the time we have for our question and answer session today. This does conclude today's conference call. Thank you for your participation, and you may now disconnect.