West Pharmaceutical Services, Inc.

Thank you for standing by and welcome to West Pharmaceuticals' fourth quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. I would now like to hand the call over to John Sweeney, Vice President, Investor Relations. Please go ahead.

Good morning and welcome to West's fourth quarter and full year 2024 earnings conference call. We issued our financial results early this morning and the release has been posted on the investor section of the company's website located at westfarmer.com. On the call today, we review our financial results, provide an update for our business, and present our financial outlook for FY25. There's a slide presentation that accompanies today's call, and a copy of the presentation is available on the investor page of West's website. On slide four is a safe harbor statement. Statements made by management on the call and the accompanying presentation contain forward-looking statements within the media of the U.S. Federal Securities Law. These statements are based on our beliefs 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 regarding the risks to which it is subject, including our 10-K, 10-Q, and 8-K reports. During today's call, management will make reference to non-GAAP financial measures, including organic sales growth, adjusted operating profit, adjusted operating profit margin, and adjusted diluted EPS. Limitations and reconciliations of the non-GAAP financial measures to the most comparable financial results prepared in conformity to GAAP are provided in this morning's earnings release. I'll now turn the call over to our CEO, Eric Green. Please go ahead, Eric.

Thank you, John, and good morning, everyone. Thanks for joining us today. I would like to begin with some comments on the fiscal year and fourth quarter 2024, followed by Bernard's detailed financial review and 2025 guidance. Then I'll close with some final thoughts on our business outlook. Starting on slide five, looking back at 2024, Wes executed on several key strategic initiatives. First, we capitalized on opportunities with the fast-growing GLP-1 market and continued our strong win rate on newly approved molecules, particularly in biologics. Second, we made great strides to reduce our manufacturing lead times, in some cases below pre-COVID levels, and we believe that industry-wide destocking is now closed to the end, as customers are generally returning to more normalized ordering patterns. Third, we returned over $560 million to our shareholders through our share repurchase program during the year. And finally, we made strategic investments in additional HVP capacity, which we expect will drive incremental growth for years to come. Shifting to fourth quarter on slide six, there were several notable achievements. Results were above our expectations as revenues increased 3.3% on an organic basis. And the quarter marked a return to quarterly revenue growth. Proprietary product organic revenues increased 4.5% in the fourth quarter. This represents a continued improving trend as proprietary products organic revenues decline year over year in each of the three quarters of 2024, largely driven by destocking. Finally, adjusted operating profit margin was 21.7%, roughly in line with prior year. Moving to slide seven, West's proprietary product segment can be broken down into three categories, HPP components, HPP delivery devices, and standard products. I'm pleased to report that HPP components, the most important contributor to West's long-term growth, is starting to show signs of strengthening, and we expect this positive momentum to continue. Our current expectation is that HPP component revenues will grow mid to high single digits in 2025, and we anticipate that we will see a continued mix shift to HPP in 2025 and beyond. A key performance driver is the biologics market. We expect this end market to continue to grow high single digit to low double digits, and we have a consistently strong win rate, participating on approximately 90% of new molecules entering this market. Our HBP GLP-1 elastomer business is performing well, and we expect an acceleration in growth due to the continued market expansion of this category. I would note that we have just agreed to terms for a multi-year contract with one of the largest manufacturers for all of their GLP-1 primary packaging elastomer needs. We remain particularly encouraged with the progress from our customers adopting Annex I. For those unfamiliar with the EU GMP Annex I, it is a set of regulations that govern manufacturing of sterile drugs in the European Union. Annex 1 requires companies filling sterile medicines to develop a documented contamination control strategy that assesses risk in their facilities and defines action plans to prevent the contamination of sterile products. Currently, we have over 200 Annex 1 projects in various stages with our customers. While the regulation went into effect in August of 2023, some customers were early adopters in a shift towards HVP, and we now have additional customers in the pipeline. It generally takes about 18 months for customers to shift from standard to HVP products as they address Annex 1. Moving to slide eight, high-value delivery devices. The biggest growth driver for this business in 2024 is our wearable on-body injector SmartDose. We are working to optimize our manufacturing process with our new automation line coming on stream later in 2025, which will more than double our SmartDose capacity and drive efficiencies. While we categorize and view SmartDose as an HPP product, we expect that in 2025 it will be margin-dilutive. We are taking steps to improve our delivery device economics, and all options are on the table. Moving to standard products, these are the bulk products that we produce across our global manufacturing network. These products tend to be on the lower end of price and margins. The standard components are mainly used by our pharma and generic customers. Turning to slide 9, in contract manufacturing, we have made significant investments to build out our GLP-1 device business. The business is growing strongly and now accounts for approximately 40% of our total contract manufacturing. We anticipate the GLP-1 growth to continue as our investments in Dublin, Ireland, and Grand Rapids, Michigan come online during the year. There are two large continuous glucose monitoring customers that we serve. In both cases, these customers develop next-generation devices. We have made the decision to not participate going forward as our financial thresholds cannot be achieved. One of these customers has started to exit, and the other has let us know of their intention to exit in mid-2026. We're actively pursuing opportunities in CM that more closely align with our margin in capital return requirements. Taking all into account all these factors, we expect a return to organic growth driven by the strength of our HVP components business. We have a highly profitable core business that will bridge west through these temporary impacts. We will be taking steps in the coming years to address these areas where we want to improve returns, and we expect to finish 2025 with solid momentum. Now I'll turn the call over to Bernard. Bernard?

Thank you, Eric, and good morning. I will take you through the drivers impacting sales and margin in the quarter, as well as some balance sheet takeaways. And finally, we will review our first quarter and full year 2025 guides. First up, Q4. Our financial results are summarized on slide 10. We recorded net sales of $748.8 million in the quarter, representing organic sales growth of 3.3%. Looking at slide 11, proprietary products organic net sales increased by 4.5%, This was a function of generally improving demand and strong sales of delivery devices in the quarter. Fourth quarter revenues included a $25 million benefit from a delivery device incentive. High value products, which made up approximately 74% of 4Q proprietary product sales, generated mid-single digit growth led by customer demand for self-injection device platforms. Looking at the performance by market, Biologics experienced high single-digit organic net sales growth, driven by increases in sales of self-injection device platforms. Pharma saw mid-single-digit organic net sales growth, driven by an increase in sales of Westar products and administrative systems. Generics had a mid-single-digit organic net sales decline, driven by lower volumes of Floratech products. Our contract manufacturing segment declined by low single-digits. We recorded $273.6 million in gross profit, and gross profit margin was 36.5%, down 150 basis points year over year. Adjusted operating profit increased to $162.8 million this quarter, and adjusted operating profit margin of 21.7% was consistent with the same period last year. Finally, adjusted diluted EPS declined 0.5% for Q4. The stock-based compensation tax benefit had no impact on EPS compared to the same period last year. Now let's review the drivers in both revenue and profit performance. On slide 12, we show the contributions to sales growth in the quarter. Sales price increases contributed $39.3 million or 5.4 percentage points. Included in sales price is a $25 million customer incentive associated with achieving volume levels. The pricing benefit was partially offset by a negative mix impact of $15.3 million, driven by lower sales volume of HPP components and a higher proportion of lower margin drug delivery devices. In addition, we faced a foreign currency headwind of approximately $7.2 million in the quarter. Looking at margin performance on slide 13, proprietary products fourth quarter gross profit margin of 40.8% was 190 basis points lower than the margin achieved in the fourth quarter of 2023. The key driver for the decline was product mix. Contract manufacturing fourth quarter gross profit margin of 17% was 90 basis points lower than the margin achieved in the fourth quarter of 2023. On slide 14, we have listed some key cash flow metrics. Operating cash flow was $653.4 million in 2024, a decline of $123.1 million, primarily due to a decline in operating results. In 2024, we spent $377 million on capital expenditures, a 4.1% increase over 2023. We continue to leverage our CapEx to increase our high-value product and contract manufacturing capacity. Working capital of approximately $988 million decreased by $277 million from 2023, mainly due to a reduction in our cash balance. Our cash balance at December 31, 2024, was $484.6 million, but $369.3 million lower than our December 2023 balance. The decrease in cash is primarily due to $560.9 million of share repurchases and or capital expenditures offset by cash from operations. Turning to guidance, slide 15 provides a high-level summary. Full-year 2025 net sales guidance is expected to be in a range of $2.875 and $2.905 billion. There is an estimated headwind of $75 million based on current foreign exchange rates. We expect organic sales growth to be approximately 2% to 3%. This guidance assumes acceleration in HVP organic growth and that HVP components margins will expand, driven by biologics, GLP-1s, and Annex-1s. We anticipate organic revenues in a proprietary product segment to increase as the impact of destocking continues to abate. Proprietary products gross margins are expected to be up slightly as compared to prior year, driven by improving HVP components performance. Contract manufacturing revenue is expected to be up low single digits as compared to FY24, as decreased revenue in continuous glucose monitoring business offsets expected growth in self-injection devices for obesity and diabetes. Contract manufacturing margins are expected to decline 200 basis points year-over-year in FY25 due to lower utilization. Just a note on the ramp-up of our two CM sites. In Dublin, the building is now up and running. Auto-injector production has commenced and will continue to ramp as we move through the third and fourth quarters. Late in 2025 and into 2026, we expect both revenues and margins to benefit from the ramp up in the pain and drug handling portion of the business. The Grand Rapids expansion is also operational, and we have our first revenues in the third quarter of 2024. These revenues will increase as we achieve scale in mid 2025. Our experience with new installations is that they take up to 18 months to achieve close to full capacity. Moving on to slide 16. For 2025, our EPS guidance is now anticipated to be in a range of $6 to $6.20. Please note we have several exciting incremental opportunities not incorporated in this guidance, and we will update you on these in 2025 should they materialize. Slide 16 breaks down the progression from 2024 EPS of $6.75 to the 2025 guidance range. The guidance anticipates that proprietary products revenues, excluding the impact of our drug delivery device 2024 incentive, accelerate with improving margins, adding 77 cents to 2025 EPS. This is more than offset by incentive compensation, plus the tax benefit on stock-based compensation, which is not incorporated in our guidance, and the currency headwind total to about 77 cents. The drug delivery device incentive headwinds and glucose monitoring transition reduced 2025 EPS by about 43 cents. And incremental investments in R&D and SG&A in 2025 are 22 cents. In total, these factors get us to our 25 guidance range of $6 to $6.20. For CapEx, we are on a glide path back down to our traditional 6% to 8% of revenues, to support our long-range plan. We now anticipate 2025 capex of $275 million, down $100 million from 2024. We expect that 2024 will be the peak investment year for our growth initiatives over the next several years. Finally, Today we are introducing first quarter 2025 guidance and anticipated revenues in the range of $680 to $690 million, which translates into 1% to 2% first quarter organic revenue growth. And first quarter 2025 adjusted EPS is expected to be in the range of $1.20 to $1.25. I'd now like to turn the call back over to Eric.

Thank you, Bernard. To summarize on slide 17, we are pleased with a strong finish to the year, and with the opportunities ahead, I'm confident we will deliver on a successful 2025 for West. Our performance in HVP components is encouraging, and we are seeing a return to growth in our proprietary business because of our continued success in biologics, GLP-1s, and the adoption of Annex I. We anticipate that 2025 will be an important year that positions the company for the future success. We intend to capitalize on our strengths and continue to address areas that require additional attention. In closing, I would like to thank our team members across the globe for their unwavering dedication as they continue to make a difference in improving patients' lives. With that, operator, we are ready for our first question. Thank you.

Thank you. As a reminder, if you have not already, you may press star 1-1 on your telephone to queue up. Please stand by while we compile the Q&A roster. Our first question comes from the line of Michael Riskin of B of A Global Research. Your question, please, Michael.

Thanks for taking the question, guys. A lot to unpack here. I'm going to ask It's going to be one question, but I'm going to ask a big one. So if I just look at the fiscal year 25 EPS guide, obviously it's well below expectations. I appreciate the color on the bridge, the progression from 24 to 25, the moving pieces. What I want to get at is sort of like what's a one-time versus a reset to a new base. So if I look at R&D, SGA investments, that seems like that's sort of part of the model, right? We can debate tax, FX, incentive comp. Is it fair to say that everything outside of the contract manufacturing CGM issue is sort of the new base and that, you know, $6, 620 guide is the new model for what we're moving from? And if so, anything additional color you can give us on that contract manufacturing care pocket? I mean, you just said in the prepared remarks about a 200 BIPs margin impact to sort of What's your outlook for being able to patch that hole, to bring something else in, and to sort of regain some of that EPS air pocket that you're getting? Thanks.

Yeah, thanks for the question, Michael. So when we look at the guide, a lot of these impacts are, you know, you're impacting 2025 particularly. And if you look at drug delivery device, that is a mixed impact in 2025, but we have a number of initiatives ongoing to, expand the profitability in that business. We're looking at automation. We're looking at scale. We're looking at, in more medium term, adding more customers. So we would expect that to improve over time. Now, it will take a little bit of time for us to do that. So, again, we would expect the mix impact to improve. And as the mix improves over time, EPS, also improves with that. That's what we talked about, I think, towards the back half of last year and the second half, really about the mixed impact that we were seeing in our business. As Eric called out in his script, there are areas that we are addressing. If I look at the growth in HVP, we're seeing, you know, mid to high single growth, digital growth in HVP with expanding margins are driving our business. They're slightly offset in 2025, but again, we would expect that to be corrected. The CGM impact on contract manufacturing, again, that's here in the short term. We would expect to replace that business with business that has margins more in line with what our return on investment thresholds would be. And again, so over time, we would see those margins improving.

Okay. I mean, any additional color you can provide on the CGM impact I mean, the way I'm reading it is sort of a – it was your decision to walk away from those contracts because of the financial metrics. Just, I mean, given it creates an air pocket, sort of how bad was that given these were existing customers? And, you know, we know the CGA marketplace is pretty concentrated in just two, maybe three players. So if you've got two customers, it doesn't seem like that's something you can replace there. Is that something you can flex to another product line?

know outside of CGM yeah Michael good question and that's exactly what we're what we focused on we've had the ability to support our customers with CGM for the past 10 plus years in particular the technologies that were introduced early on in the ramp up of CGM in the marketplace and So we've had a strong position as new technologies were developed by our customers. We did take the decision based on the economics that just did not meet our financial thresholds. And that decision was not taken lightly, but we wanted to make sure that we preserve the the financial construct we believe is appropriate for that business that we provide in our contract manufacturing space. So therefore, we're doing a really well-scheduled ramp down as they can move into the next generation through whether they're insourcing some of it. In fact, many cases they're insourcing. So That was the decision we made, and that is we will reuse. Let me state it clearly, though. There is space that will be available, which is being looked at and worked on with other customers to be able to support future launches and future product portfolios that we'll put into contract manufacturing going forward. The impact will be in 2025, and we'll move through it. It's offset with some of the GLP-1 growth and other CM business that we're bringing in.

All right. Thanks so much. I'll get back to you. Thank you.

Thank you. Our next question comes from the line of Larry Solo of CJS Securities. Please go ahead, Larry.

Great. Good morning, gentlemen. I guess first question, just on the proprietary product side, and again, I know you don't guide to segments, but it sounds like just the general outlook there is positive. And does that scale up as we go through the year? Or obviously, I guess Q1 is seasonally usually a little bit slower, but is there any inventory issues that continue to wane as we move forward? And then the second part of the question is, so it sounds like the The core HVP is doing okay, but there will be a little bit of a transition on smart dose and lower margins. Maybe you can give us a little more color on that side of the equation, too.

Thank you, Larry, and thanks for the question. So, no, you're absolutely correct. Let's take a look at proprietary as a whole. The key drivers of that business we'll start with is the HVP components. That has been the thesis of growth for us for a number of years. And we still feel strong about our prospects and the current pipeline that we have in place. What's driving it? Number one, biologics. As we think about our continued strong position in that particular market, we mentioned that we're still, just looking at the past year, past quarter, we still have a very high participation rate of all new launches that have been approved, around 90% plus. And I just want to be clear on that. We do put biologics and biosimilars together because the value proposition to our customers and the economics are the same for us. We are in the top 50 biologics. And if you think about the pipeline of biologics that are being developed, it's quite robust. And so we feel really good about this space. That growth will continue in the near term of 2025, but well beyond that. The second lever is GLP-1s, and our position in GLP-1s is not just in contract manufacturing, but we have a very strong foothold in the proprietary HVP elastomers, primarily providing plungers for the largest players in this space. We did comment in our prepared remarks that we have secured a long-term contract with one of the customers, provide all of their proprietary elastomers needs in the GLP-1 space. And we are working with another customer to continue to have majority of their needs going forward. So that is the GLP-1s. And to give you a little context there, it's about mid-single digit from a, in 2024, the size of the business against all the proprietary. The third area is Annex 1, and we talked about it, but we're starting to see, instead of talking about the pipeline, actual projects that will turn into revenues in 2025. We're actually quite encouraged. We had an increase of interest in projects we've launched, well over 200, more than double-digit from the last quarter I mentioned. And roughly around 50% of those projects will turn into some sort of revenues throughout the duration of 2025. We believe that's going to give us about 100, I'm sorry, yeah, about 100 to 150 basis point growth expansion just in that particular area. So HPP components, very strong going forward. You asked about the destocking. It's consistent to what was said on previous quarters. We believe pharmaceutical or pharma customers have normalized. Biologics is becoming more normalized as where we are today. And then we believe generics will become more normalized throughout the duration of 2025. So consistent to what we have said before. And that's all based on the more consistent ordering patterns of our customers going forward. I do want to touch on SmartDOS because you asked about that topic. SmartDOS, we have been in the wrap-up mode in 2024. We onboarded Phoenix site in the latter part of first half of 2024. As you know, it takes time to get to full efficiencies of a particular site. It was another expansion of manual processes. So when Bernard talked about we're going to drive automation that's in-house, It will take pretty much 2025. If we can bring it forward, we will. But we will be driving more towards automation, take costs down. We are looking at scale as the volumes are increasing significantly for us, for our customers. And in addition, more midterm, we're looking at new customers. But I will say we are looking at the portfolio specifically around this device. and determining the best actions forward to ultimately increase shareholder values. So that's our focus on here while maintaining and supporting our customers and their patients. So those are the key topics that I believe I covered that you asked. Any other, Larry, any other points?

No, that was a really good call. I guess just to follow up on any, you know, Anything you can add, just maybe a little tease on where the incremental opportunity is not included in guidance? Is that just a bunch of different things across the P&L? Is there anything specific we could point to there?

Thanks. Yeah, Larry, I don't want to create a wider range here. I just want to say that I do believe the way we look at our guidance is, you know, business that we have very clear visibility of and we I'm very confident that we can execute against. I'm confident in our team. I do believe HVP Components is a growth driver for this business. It's showing up very strongly early on in 2025, and we expect that to drive. I mentioned the three areas, biologics, GLP-1s, and NX-1. These are very discrete projects, initiatives that we have our hands around. And then we have to fix devices. particularly one part of that portfolio, and that is a focus of the team, and we need to improve the profitability. And we do not have a lot of time to get that done. So that's the mandate. And I expect the teams to over-deliver, but I'll leave it to them.

And just to follow up on that, Larry, with the number of these opportunities, some are more in the short term and then some are medium term. opportunities, and we'll update as we go through the year as to how they're transpiring. But just to put it in context, that we have the ability to respond quicker than we probably have in the past based on the capacity we've installed, particularly in our HVP sites over the last number of years. So we have that ability. Our lead times have come down considerably. So we're in a better position to take advantage of those opportunities when they present themselves.

Great, I appreciate all that, thank you guys.

Thank you. Our next question comes from the line of Patrick Donnelly of Citi. Your line is open, Patrick.

Hey guys, thank you for taking the questions. Maybe another one on the GLP side, just diving in a little bit there. Can you talk about the growth you're seeing from that market, particularly from the proprietary side, And then we do get a decent amount of questions just on the oral side, and there's going to be a few readouts here in the relative near term. Maybe just frame up how you think about the impact of orals, what that means to the market, and how you guys see that playing out.

Yeah, Patrick, good morning. Thanks for the question. We do believe that from our lens in speaking with our customers that there will be an oral impact in the market. We do believe, however, majority of the delivery will be injectable. And our models are built around a shared portion of the two. So that's how we kind of looked at our investments. How do we make sure that we safeguard the capital we put in to build support GLP-1s, and particularly around CM, where we have very clear levels of demand or volume requirements that need to be take-or-pay type environments for a number of years. So we're protecting that area. And as you know, in the proprietary side of the elastomers, a lot of those resources are fungible. But we feel really good about GLP-1s. Right now, as I mentioned, proprietary elastomers is roughly mid-single from the whole portfolio perspective of proprietary. CM is 40%. But if I think about the ramp-up, a lot of the ramp-up has been around CM with their infrastructure expansions, particularly in Grand Rapids and Dublin. More to come as we get the capabilities online. And more exciting is that in CM we're going to have drug handling capabilities towards the end of 2025, early 2026, which is an expansion of our capabilities but better better margin profile for West. On the proprietary side, that's going to be the fastest growth area in 2025 for us. Actually, it's, you know, think about a two-thirds versus one-third between the two units. And that is in line with our customers' expectations and our position with both of them from a, you know, you know, what I call a penetration rate of success, win rate with both customers.

Okay, that's helpful. And then maybe, Bernard, just to build on Mike's question earlier on the margin, can you just talk about, I guess, the build as we work our way through the year? I'm just trying to think about the right exit rate, the right way to build into 26. And again, is this product mix-driven, manufacturing ramp? Just talk about those moving pieces. And again, maybe the progression as we go through this year would be helpful.

Thank you, guys. Yeah, so based on the guide we put out, Q1 is the most challenged from a margin perspective. We still see a little bit of destocking, particularly impacting generics, maybe a little bit on the biologic side. And that is we progress through the year. To get to our guide, we would expect to see improvement on the margin front. And that's coupled with the growth in high-value products, particularly around the containment space and in the areas that Eric talked about, GLP-1, NX-1, and biologics, and then the return to growth of HVP as we progress through the year.

Does that help?

Next question comes from the line of Doug. Your line is open, Doug.

Hey, good morning. I'm doing well. Good morning. Thank you for taking my question. So, I think three quick ones. I'll just rattle through them all at once. First, you have three facilities in Mexico. I just want to see how you're capturing any potential tariff impact in your guidance. So that's one. The second is, I think, based on some of the disclosures in the slide deck, it looks like the math would lead us to conclude that clip ones as a percentage of sales are about 10%. I just want to make sure that's right. And then the third is, you talked about several exciting incremental opportunities, not included in guidance, as you talked about things in your prepared remarks. Any chance you would be willing to size up how impactful those could be? Thank you.

Excellent, Doug. Thank you. So the first question about Mexico, we do have a relationship with a company called In Mexico, it's a 50-year relationship. Actually, yeah, about close to 50 years where we are the minority stakeholder in that business. And it's immaterial. The materials that we support them to be able to support the local market, but a lot of it's local for local. On the GLP-1s, you're accurate. It's ballpark, about 10%. with the GLP-1s of the overall business, but in CM, as I mentioned, it's about 40%, and the proprietary is about 5%. The growth of that is mid-single digits. The growth of that is very attractive. We'll look at a couple basis points, expansion from 24 to 25.

On the GLP-1, I think it's like GLP's, And proprietary GLPs are about mid-single digits for total revenue. And then the contract manufacturing GLPs represent about 40% of the contract manufacturing revenues, and not our total revenue. Then if we look at GLPs in total, it's really like mid-teens of our overall revenues. And obviously then the economics around those businesses are a little bit different. And where we see the most growth, I think back to Eric's comment you know, a few minutes ago is really around the elastomer side where we're seeing a lot of traction with both, well, with the primary GLP-1 providers.

The third question around growth opportunities, I mean, obviously we will continue to focus on expansion within HVP components, see if we can help our customer accelerate some of the launches that they have planned and also the uh some of the regulatory work that we're partnering with them on with annex one and obviously we will respond accordingly uh with glp1 growth um so those we but i think at this point in time that's probably this bunch will provide on the potential uh additional growth levers as we think about uh throughout 2025. yeah we will update as they um you know we get closer to them

having an impact on our numbers. So it's kind of hard to give you a sense of what they are now.

Understood. Thank you.

Thank you. Our next question comes from the line of Paul Knight of KeyBank Capital Markets. Please go ahead, Paul.

Hi, Eric. You have had a long-term guide or construct of a 7% to 9% organic growth. As we leave 2025 with capacity additions in place and the GLP-1 elastomer business in place, what do you feel about that seven to nine construct?

Good morning. I believe long term, if you think about the seven to nine percent, it feels very strong that we will be able to return to those type of top line performance metrics and in particularly I think in 2025 we'll see ourselves transition into that direction. And to your point, the key thesis of the growth is going to be around HPP components and proprietary. And so the early signs for 2025 are very strong. It's not one particular area, it's multiple areas, multiple customers, multiple drugs and categories in the marketplace. So we feel that we're getting to more normalized environment, which will allow us to get back to that growth algorithm that we had historically.

And then maybe I think Bernard, you were commenting on the Dublin GLP-1 news site. you're expecting what utilization in the year, excuse me, 2025, is it at half of capacity for the year? What's your kind of view on what it's going to be producing relative to potential revenue?

Yeah, Paul, I think where it becomes more material is in the back half of the year. We're at the early stages of ramping at the moment. And, you know, as we get into the back half of the year, we start to see the ramping around particularly around the auto-injector element of the business. And then as we get into the later part of 25 and into early 26, that's when we would see drug handling coming on board. So it does take time. We've seen Grand Rapids starting to ramp at a start as we've got through the back end of 24 and we'll see that continue into 25. But Dublin, we won't really see a lot from that facility, I think, for the first half of this year.

And you, last question, it would be, you cited drug handling. Does this mean you're doing complete component assembly? It's not fill finish, is it?

No, it's not fill finish. It's final drug packaging. But we're not doing fill finish.

Okay, thanks.

Thank you. Our next question comes from the line of Matthew LaRue of William Blair and Company. Please go ahead, Matthew.

I'm going to start on the device side. Obviously, that's been a big theme over the last couple of years has been investment in that space, and I know you've been excited about the future there. You referenced today some of the challenges you've had in terms of financial profiles as well as converting to an automated line. Eric, I think you would use the word maximizing shareholder value as you think about options, which sounds like, I guess the question is, is there an existential question as to whether that should be a core competency of the company long-term or more about harder operational decisions that would need to be made in the near term to maximize profitability?

Yeah, Matthew, there's two points to that. One is more near-term, what we have in our hands to be able to produce consistently high-quality product for our customers as we scale because the demand is increasing and be flawless in the execution of the automation so we can go from a manual to a fully automated process which will drive efficiencies and there's other operational excellence drivers that we are focused on in that area to deliver on. As we scale, we will get better economics, but beyond that, we do have to just continue to pressure test what's the future look like for that device, that particular device, because the drug delivery device for us is beyond just one product. We do have pretty attractive portfolio around admin systems. We do have what we call self-dose and also our Crystal Zenith line. So if you think about the drug delivery device area, this particular product is one that we're really focused on right now to determine what is the long-term best option for West.

Okay, understood. And then just on the multi-year contract, GLP contract you mentioned, could you frame what your, like how that participation rate and duration of contract would compare to your prior, just to give a sense for what really is incremental there?

Well, in that particular case, we were on and have historically been on all the, provide all the Elastomer components for our customer. And so what this does, it secures that position for multiple years. We have not articulated exactly the duration, but it is quite lengthy. And so it is a drastic departure of our customer. And as you know, it takes a long time to build that rapport, that credibility, and that supply chain. So we feel really comfortable. It was a natural progression of our relationship just to secure it. and ensure that we're both aligned on future expectations, that we can help them and support one another, make sure that they can support their end patients at the end of the day with the drug launches. So it is long in duration. We haven't articulated exactly the number of years, but it is very long. And it is a continuation of our participation, which is basically all their needs in that market with that customer.

I think, Matt, it's also very important to, you know, it supports the growth in the GLP-1 market and feeds into the long-term construct that we talked about as one of the key drivers there. Now, we've ring-fenced that. So it was very important for us to get that done. And, again, so it's really supporting that growth around HVP over the long term.

Okay. Thank you.

Thank you. Our next question comes from the line of Justin Bowers of Deutsche Bank. Please go ahead, Justin.

Thank you. Good morning, everyone. Just a couple of clarifications here to kick it off. Eric, on the 100 basis points of growth expansion from NX1, is that referring to 2025 specifically or is that sort of like a longer term contribution. And then on the device part of the business, you said that, you know, there's a mandate there. And is that related to the contract manufacturing side of the business or also in prop products as well?

No, thanks for the question. The 100 basis points that reference the 100 to 150 is really 2025. So these are projects that we were sharing with you last year and just wanted to give visibility that now they're converting into actual revenues for 2025. It takes about 14 to 18 months to do the transition, sometimes a little bit longer with our customers. And so that's why I wanted to mention it enough to realize that it's starting to becoming impactful. for us near-term. And we do believe that there's long-term growth trajectory on this, but we really haven't framed that as we speak. But it's been contemplated in our long-term growth algorithm for high-value products. On the device side, that is specifically, my comment was specifically around the proprietary devices. And to be very clear, it's around our smart dose platform.

Okay, and then a follow-up to that, in the prepared remarks you talked about price and incentive headwinds, and you called out $44 million in the second half of 2024. Is that ring-fenced there, or is there more to that? And then, you know, unrelatedly, you know, HVP mid-single digit back in mid-single digit growth this year, and then biologics high single to low double. Is there any anticipated, you know, restock there, or are those, you know, back to run rate levels?

I'll start with the last one first, if you don't mind. We believe that it's more of a natural back to the growth algorithm that we expect with biologics and HCP as we progress through 2025. So we don't see this as a restock since we do believe it becomes more normalized. And as you know that once you're on the molecule, you tend to be on it for the duration of that drug in the market. And so it's really starting to harmonize with their supply chain needs going forward. On the first question, I think we mentioned the 44 cents on EPS. Not all of it is related to the device, but majority is. So a good portion of it is. A little, some of it, the smaller portion is related to the transition that we're seeing on the CGM business transitioning out this year and then also towards the tail end of last year. I'm sorry, next year. So the impact, but we'll obviously use that asset, those locations to fill with new contracts, new customers that meet our financial construct. So that's kind of how you would look at that 44 cent headwind this year.

Thanks for all the questions. I'll jump back in queue.

Thank you. Thank you. Our next question. comes from the line of David Windley of Jefferies. Your line is open, David.

Hi. Good morning. Thanks for taking my questions. I have a few. I hope I can squeeze them in. So the first one, kind of on the last, on Justin's question, I believe that your messaging in the second half of last year as you were seeing the ramp of your on-body wearable production and supply to the one key client that you were ramping, was that you hoped to get some of this incentive fee value kind of converted into base price. I gather from the guidance that you're giving around this that you didn't. My math suggests that the incentive fee would have been worth 46 cents or so. And so I'm wondering, can you be a little more specific? Did you get some of it baked into base price but not all? Or how did that play out, if you don't mind?

Yeah, the way I would respond to that, David, well, first of all, good morning, is that the incentives far exceed the pricing that we have established so far in 2025. So I won't dimension any further, but it is the incentives in the latter part of 2024 as we ramped did exceed the going forward pricing.

Understood. But I'll sit down after that. we're also seeing better production efficiencies and yield on that line. So we're improving on the cost side as well as the price. So when we're looking at how do we improve the economics around this device, it's looking at it from both a price perspective and also from a cost perspective. So we're working a couple of different areas on that. So that gets us to that 33.

Got it. I probably should have started with this one so as not to jump around, but the the investments in SG&A and R&D, what are those specifically? And maybe talk to the timing of those, like why do those need to be made now?

Yeah, so in the R&D area, specifically the largest incremental investment that we're making in 2025 is is to build out and be prepared for the launch at the end of this year or early next year of our integrated system. So this is the for human use prefilled syringe system that we have been working on with our customers. And we actually did launch, not for human use, prefilled systems with borosilicate Earlier this year, the receptivity was very high. The engagement with customers was very strong. And therefore, we felt really comfortable to continue the planned path that we were on to execute and make sure we hit the timetables that we've established a couple years ago with this product launch. It's new, it's early, but the adoption is quite exciting and more to come as we get to that point. But that is probably the largest incremental piece of our R&D from last year to this year, clearly.

Okay, and on the SG&A side?

Yeah, on the SG&A side, Dave, a lot of the incremental costs there is the annualization of costs that were being added as we were getting towards are getting through 2024, so when they get fully annualized, we have a little bit of a step up there, and there's some, you know, your normal merit increases, but we're not adding any additional resources from an SG&A perspective, so they're really costs that are carrying through, and then your annual merit increase.

Got it. Okay, so then coming back a little bit, kind of bringing the device question back in, and this is a little bit of Matt LaRue's question. So if I, I believe, you know, I've covered the company for a long time. I think the tech group acquisition dating back to the 2000s, in fact, is the basis of your kind of foundation of your contract manufacturing business. And I believe the strategic import of that for you is to have the capability to parlay, so to speak, into some of the injection molded proprietary devices like the OnBody that you're bringing to market. So I guess it gets back to the existential question that the contract manufacturing business is proving to be lumpy. You're moving out of CGM but into what is now going to be a very high client concentration in the contract manufacturing business. And I can understand where you would want to tolerate that for the contribution that could make on the proprietary product side, but the on-body wearable device margins are just not attractive enough to justify pursuing, it doesn't seem. And so I guess I come back to, is that pursuit worth it, I guess, is the basic question. Because if I understand correctly, based on your answer on the on the on-body wearable, those margins are probably the lowest in your portfolio at something like 10%. So, sorry for the very direct question, but just really wanting to understand why this makes strategic sense to continue to pursue, given the margins, the lumpiness, and the CapEx requirement. Thanks.

Yeah, David, as we look at it, it separates the two on the on-body wearable for the proprietary side. That technology is making an impact, but the economics on the scale-up has not met our expectations. And so therefore, we have to, as Bernard mentioned, we are driving ways to improve efficiencies through operational excellence, through automation, and through scale. However, to your question, we are looking at all options right now about the fit of this part of the portfolio long-term. On the contract manufacturing side, while some of the skills and resources did come out of that group to be able to support the buildup of that portfolio a while back, it is still independent and it actually does support us when we think about diversifying our top line. It also allows us to have a larger, more robust relationship with some of the largest drug companies because they're looking to West to support them both on the contract manufacturing side and also on the proprietary side. So on a collective basis, that does positions very well in our conversations, in our customer engagements with some of the largest drug companies. across the globe. So while they do have different economics, CN does have different economics to our proprietary, we expect those investments to have robust returns for that business. And when they don't, we have to make those decisions like we did with CGM. So I do believe for diversification, we're a top line, but same customer segment and In the spirit of being really focused on injectable medicines, we are positioned well strategically at this point with both of those businesses.

Got it. I appreciate your patience on the questions. Thank you for the elimination.

Thank you, David.

Thank you. Our final question comes from the line of Jacob Johnson of Stevens, Inc. Your question, please, Jacob.

hey thanks good morning um maybe sticking with dave's kind of strategic question and following up on a comment you just made there eric on on contract manufacturing it seems like a bit of shift in strategy for this segment historically kind of a lower margin lower growth business seems you're now going after higher growth higher return projects that maybe are more synergistic with proprietary products Was this kind of a deliberate change in strategy that happened at some point, or is this just opportunistic given what's going on in the GLP-1 market and maybe related to that? Historically, this has been a low single-digit grower. Could it be something more than that as we look out over a multi-year period?

Excellent question. I see two things here. One is in the contract manufacturing space. We think with our position, you're probably looking at mid-single-digit type growth. plus or minus for long term. And you are correct. Our focus has been, we started shifting towards conversations with customers to go a little bit further downstream. We started to think about drug device assembly and packaging, which is a higher value capability. And we're We're proving it out while it's early stage. As we talked about, Bernard gave details about the Dublin expansion where we expect to be online with the drug handling. These are active conversations we're having with existing customers that have asked us to do manufacturing and assembly of their devices, but now... Can you bring the drug delivery into the equation? So, yes, to answer your question, we're looking at shifting this business to be more differentiated and actually bring incremental value to West as a whole and still while leveraging the global relationships that we have with these large drug companies from an enterprise perspective.

Thank you. I would now like to turn the call back to John Sweeney for closing remarks. Sir?

Thank you very much for joining us today on the call. An online archive of the broadcast is available on our website at westfarmer.com in the investors section. Additionally, you may access a replay for 30 days following the presentation by using the dial-in numbers and conference ID provided at the end of today's earnings release. That concludes the call. Thank you, and have a great day.

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