Good morning, good afternoon, and a warm welcome to our Q1 2025 qualitative update, and thank you, Sandra, for the introduction. With our qualitative updates, we intend to provide you with a general business overview, but we will not be sharing figures related to our financial performance. We will do so on the 23rd of July with our half-year update. Let me start with an overview of our group performance, the current macroeconomic situation, and our growth projects before we move on to the divisional performance. We experienced a strong Q1 performance across our CDMO businesses, aligned with our expected full-year trajectory. Supported by this strong performance, we are confirming our 2025 outlook for the CDMO business, with sales growth approaching 20% at constant exchange rate compared to the prior year, and the core EBITDA margin approaching 30%.
Excluding Vacaville, which is expected to contribute CHF 500,000,000 in sales at a diluted core EBITDA margin, we expect low-teens organic CER sales growth and a margin improvement in our CDMO business. As a reminder, we define our CDMO business as Lonza, excluding the Capsules and Health Ingredients business. As anticipated with our full-year release in January, we confirm our expectations of higher sales in H2 2025 than in H1. However, we now anticipate the core EBITDA margin to be more equally balanced between H2 and H1, with a stronger-than-expected H1 leading to a correspondingly softer margin in H2. The main reason is a strong operational execution and more favorable mix in the first half.
As in previous years, we continue to experience a healthy level of contract signings across all CDMO businesses, highlighting the attractiveness of our commercial offering and providing a strong basis for our future sales growth. Customer interest in Vacaville continues to be strong, and a third long-term customer contract has been secured for the site. We can confirm that multiple contract negotiations are ongoing, and we expect more signings in the balance of 2025. Our early-stage business saw high utilization in Q1 2025, and we have good visibility for 2025 demand. At the same time, we remain attentive to the evolving funding landscape and the political uncertainties surrounding regulatory approvals in the U.S. We are also closely monitoring the recent volatility in the FX market, with the Swiss Franc gaining significantly in value, especially to the U.S. dollar.
Based on the FX rate at the end of April, we would expect a year-over-year headwind of around 2% on sales and core EBITDA for full-year 2025. However, our margin is well protected due to a strong natural hedge and our hedging program in place. Before turning to our growth project, let me say a few words on the current geopolitical and macroeconomic environment, which is characterized by an increased level of uncertainty. We believe that Lonza's global manufacturing footprint, including its significant presence in the U.S. across modalities, provides a competitive advantage that will allow us to minimize the impact of recently announced trade policies on our business. At this time, we do not expect tariffs on our manufactured products or raw materials, including pharmaceuticals, should such tariffs be implemented, to have a material financial impact. However, we continue to monitor the situation closely.
On our U.S. CapEx spending, tariffs may have a modest financial impact, potentially leading to a slight increase in overall spending. Due to the capitalization and the subsequent depreciation, we do not expect any material impact on our P&L. Given its strong manufacturing presence in the U.S. and Mexico, our Capsules and Health Ingredients business is currently well-positioned to navigate tariff dynamics and may even experience a competitive advantage. Recent countervailing filings have been accepted by the U.S. International Trade Commission and U.S. Department of Commerce against unfair trade practices related to imports of hard anti-capsules sold in the U.S. market, which are likely to add to this relative trend. The case continues according to schedule, and affirmative preliminary determinations in the countervailing case were published on March 31, with 2%-10% duties being implemented. Concurrent anti-dumping duty investigations are ongoing.
Now, turning to our growth projects, overall, we are making solid progress. Our highly potent API facility in Visp, Switzerland, reached a critical milestone and commenced ramp-up activities in Q1 2025, while we expect our large-scale milling facility in Visp to launch GMP operations in Q2 2025. Construction is progressing well at our recently announced large-scale bioconjugation site in Visp, which we expect to become operational in 2027 or 2028 at the latest. We also now expect operations to commence at our large-scale drug product facility in Stein, Switzerland, in 2027. Originally anticipated for late 2026, the timeline has been slightly adjusted due to an updated delivery schedule for critical equipment. We do not expect material impacts on our financials for 2026 and 2027 from this adjustment.
For Vacaville, we have now entered the implementation phase for the upgrade CapEx and expect the majority of the CHF 500 million to be spent in the next two to three years. As a group, we confirm our expectations to spend CapEx in the low 20s % of sales in 2025. Consistent with our historical spending pattern, we would expect CapEx to be higher in the second half of the year. Now, let me guide you through our divisional performance, still using our former divisional setup as it was still in place in Q1 2025, starting with the biologics division. There was good momentum across the biologics division, with a strong demand for our commercial offering. Improvements in the biotech funding in 2024 have resulted in an uptick in early-stage RFPs, and we expect a high asset utilization in our small-scale assets in 2025.
Looking at selected business units, biconjugates continue to see strong growth, supported by recent asset ramp-ups. The mammalian business units saw continued momentum from growth projects, including the ramp-up of our small-scale mammalian facility in Portsmouth. The Vacaville integration is progressing as planned, and the site has successfully maintained a strong quality and execution track record since joining the Lonza network. Turning to our small molecules division, we continue to see strong commercial demand and good operational performance. The division is supported by our continuing portfolio shift to higher value and complex small molecules. With high asset utilization and the ramp-up of our new highly potent facility, we anticipate sales and constant exchange rate growth in the second half to exceed H1. The ramp-up of these new assets is proceeding as planned, with additional key milestones expected to be reached in the remainder of 2025.
Looking at our cell and gene division, there has been continued customer interest in our late-stage and commercial offerings. We see good progress in our collaboration with Vertex for Casgevy, and we are ramping up production in our site in Geleen, Netherlands, and expect our site in Portsmouth, U.S., to follow later this year. Including the approval of Mesoblast Ryoncil, we now have a portfolio of five commercial cell and gene therapies, and we expect to add further commercial molecules in the midterm. Supported by the improved biotech funding environment and the increased number of RFPs in 2024, we observe sustained demand for our clinical cell and gene technology offering. We are at least pleased with the current performance, but remain attentive to the broader market environment and the low maturity of the industry, which is inherently volatile.
Finally, before moving to CHI, we are pleased to confirm that our bioscience business unit has returned to growth in Q1, with good demand for our media and buffer bioprocessing solutions. For 2025, we expect a solid performance and the business to show healthy growth again. In our CHI business, we have observed a steady recovery in demand, with Q3 2024 representing the trough. For the pharma hard anti-capsules market, we expect a return to pre-pandemic levels in the second half of 2025, while demand for nutraceutical capsules is back to positive volume growth versus the same period in the prior year after a long period of post-pandemic stocking. The recent geopolitical developments illustrate the benefits of having a strong manufacturing presence in North America.
We have the largest U.S. manufacturing site for capsules in Greenland, South Carolina, and our site in Puebla, Mexico, allows us to produce for the U.S. market at high quality and is currently tariff-exempt under the U.S. Mexico Canada Agreement, USMCA. Progressing successfully on its recovery path, we confirm our 2025 outlook for CHI to return to positive low to mid-single-digit CER sales growth and an improving core EBITDA margin in the mid-20s, a small improvement versus our initial guidance for the CHI margin. Before I close, let me say a few words on the progress to part way with the CHI business. We see a high level of continued commitment from the affected colleagues and a strong focus on operational execution during the transition period.
We remain strongly committed to the CHI business and continue bringing new product innovations to market, as well as the rollout of our next-generation D90 capsules manufacturing lines across our network. In addition, we just recently announced to expand our capsules manufacturing capacities in India and China for the fast-growing APAC region. In Q1, we mandated our external advisors, and we are currently in the preparation phase of the carve-out. Considering the positive business development in recent months, in line with expectations, we are confident of the successful completion of a transaction at the appropriate point in time and in the best interest of customers, employees, and our shareholders. To close, let me provide some final remarks. We are seeing good momentum and are confident of delivering our full-year outlook 2025. We see strong contracting levels and good interest in our early-stage offering.
As said, we are well-positioned in the current geopolitical environment and do not expect any material impact from tariffs on our business. We continue to monitor developments closely as the situation is constantly evolving. On April 1, we have implemented our simplified and streamlined operating model to support our new One Lonza strategy. This setup will provide us with a more scalable organization, improve the customer experience across business platforms and technologies, and provide us with elevated execution capabilities in the construction and operation of our assets. This Q1 update will therefore be the last time we comment on our former biologics, small molecules, and cell and gene divisions. For our half-year results, we will comment on our new business platforms, integrated biologics, advanced synthesis, and specialized modalities.
We will continue to report on Capsules and Health Ingredients in its existing structure, as it will continue to operate as a separate business within Lonza. To provide comparability with historic financials, we will publish restated 2024 financial figures ahead of our half-year reporting in late May. I would like to thank you for your time.
Over to you, Sandra, for the Q&A.
Thank you. We will now begin the question and answer session. Anyone who wishes to ask a question may press Star and 1 on the telephone. You will hear a tone to confirm that you have entered the queue. Kindly limit yourself to one question only. You can get back in the queue again if you have a follow-up. If you wish to remove yourself from the question queue, you may press Star and two.
Questioners on the phone are requested to disable the loudspeaker mode. In case of difficulties with understanding your question on the phone, we will ask you to submit your questions via the chat box in the webcast. Anyone with a question may press Star and 1 at this time. Our first question comes from Ibrahim Dan from JPMorgan . Please go ahead.
Hello. Hello. This is Dan Ibrahim from JPMorgan. Hopefully, you can hear me okay.
All good, Dan. Thank you. Go ahead.
Okay. Great. Thank you for the phasing comments. Maybe just to ask further, how are you thinking about the phasing of sales growth between H1 2025 and H2 in the context of the strong Q1 that you have just reported? Maybe tied to that, how should we think about the phasing of the a half billion of Vacaville revenues in 2025?
That would be the first question. My second question is just on the early stage. Any changes that you've seen in RFP momentum in Q2 or in Q1 as a result of some of the volatility in biotech funding and FDA uncertainty that you highlighted? Or is it continued to be strong momentum from an RFP perspective? Thank you.
Thank you, Dan. Yes, I think we provided some commentary on H1 and H2. I think the change being more on the margin side than on the top line. I will not go into further details on the top line. I think we mentioned that H2 sales in absolute will be bigger, will be higher in the second half than in the first half. I'll leave it at this for now. I think please note the more balanced margin outlook that we now provide.
In terms of Vacaville, I think equally we're not providing more detail on the Vacaville phasing, but we'll, of course, provide you with an update in July. In terms of the early stage, I think we've been clear to not talk about momentum because I think we see good utilization of our assets. I think we have seen good RFPs levels, and I think they were improving during 2024. I wouldn't say the same for 2025, but that doesn't concern us for this year and for early next year. Given the environment, especially in the U.S., I think we would prevent from talking about momentum.
The next question comes from Charles Weston from RBC Europe. Please go ahead.
Hi. Thanks for taking the question.
You've mentioned the time scales for the commercial aseptic facility at Lonza outfit, but I recollect you've signed a number of development deals that include these aseptic services. Could you just comment on interest in general for this facility, whether this delay creates any issue for any of your clients, and also whether we could expect the ramp-up timelines for that asset in line with other large assets, i.e., three years from opening? Thank you.
Hi, Charles. Thanks for the question on our cell and gene facility in Stein, Switzerland. I think the small shift in time scale does not impact customer programs and therefore does not create really a larger issue or a material issue on our financials for 2026 and 2027, as I mentioned in my intro.
I think in terms of the ramp-up, probably this is a smaller ramp-up than a facility where you do drug substance. Why? Because we are using this to provide fill-finish capacity to our drug substance customers, and therefore they will come when they're ready rather than piling up customers at the beginning to get them started as quickly as possible.
The next question comes from James Vane-Tempest from Jefferies . Please go ahead.
Yes, hi. Thanks for taking my questions. A quick one to begin with. I think you originally mentioned carve-out financials will be available in June. Just wondering what the latest thinking is and when we may get those. My second question is, you signed an agreement with Vertex in 2023 for a dedicated facility for type 1 diabetes in New Hampshire. In March, VX264 was discontinued.
Just how should we think about conceptually the financial impact from developments like this? Do dedicated suites require more work to make ready for new customers? Thank you.
Yeah, thank you, James. Maybe just to be clear, I did not promise carve-out financials for June, which I think you're probably talking about Capsules and Health Ingredients. I have not made any promise on carve-out financials, and we'll certainly not be providing these externally. What I was talking about are restated financials because we have changed our organization structure from the four divisions up to the first quarter of 2025 to the new platforms as of April 2025. What we will provide you by the end of May are basically the half-year 2024 and the full year 2024 in the new organization structure with the new platform.
You'll be able to see that Advanced Synthesis was this amount of top line and bottom line in 2024 versus what we will then be presenting in July this year. Here we're talking about our new One Lonza organizational structure. We're not talking about the CHI carve-out financials, which will not be provided externally. Second, on our Vertex agreement, indeed, we are building a manufacturing site for the type 1 diabetes product. Remember, Vertex has two type one diabetes candidates. One is VX264. The other one is VX880. While we have as well heard about the VX264, results of the VX880 candidate continues, and therefore there is, at this point in time, no change in our plans with Vertex.
The next question comes from James Quigley from Goldman Sachs. Please go ahead.
Great. Thank you for taking my question.
I've got a high-level one on capacity.
Following the tariff announcements, we've seen a number of big numbers for investments for pharma companies in terms of investments in the U.S. Now, a lot of that obviously relates to R&D as opposed to CapEx. What are your views on these announcements and how they might impact the supply and demand balance, as well as outsourcing rates in biologics? In your modeling, how much of this capacity was already anticipated versus brand new additional capacity that may have been in a different location relative to the U.S.? Thank you.
Yes. I think we've seen, of course, the big announcements, $150 billion plus, depending on when we stop counting.
I think what we've also seen, probably like you, is that there's actually little detail on what the mix is of investments, what is the mix between R&D and manufacturing, let alone understanding if we're talking drug substance, drug products, or modality. It is still relatively opaque and therefore hard to judge. Our understanding is that most of these investments are not necessarily additional but have been announced in one go. Most of these investments over time would probably have happened. I think this is one thing, but we don't know much more than what you hear or what we have been able to read. Probably time will tell. Important to note that if the capacity is actually being constructed in the U.S., this will take 5-10 years to materialize. I think unless you're sitting on land with permits, you need to find the land.
You need to apply for permits. We've heard now President Trump asking to speed up the permit delivery, but still, this takes time. You need to start designing the asset, constructing the asset. All of this takes time. I guess we will see over time how much it is. I'd like to remind you that in terms of driving the volume for the CDMO industry in general, there are three main drivers. One is the need from biotech companies, as most of the innovation actually comes from biotech companies who, by design, do not invest in own capacity as they prefer to spend their money on R&D and ultimately commercialization. That's one driver. The second driver being biosimilars, where again, biosimilars' entry usually increases the need for volume across the world. Also, most biosimilar companies do not build their own facility.
Only third are the investment by big pharma. The last one is potentially impacted by this announcement. The first two are not. We remain confident on the demand and value for the next year. Of course, we would adjust our models as we understand better the investments that are being made.
The next question comes from Dylan Van Haaften from Stifel. Please go ahead.
Excellent. Thanks for taking my question. Just a question on the call-out of the early stage and the clinical stage strength. I think on one hand, we had a weaker Q1 last year, specifically here. On the other hand, if you look at the street more generally and you look at CRO activity, it still feels kind of soft. Could you explain a little bit where that view to strength comes from? Is that pharma? Is that biotech?
Is that concentrated on U.S.? Any color would be helpful. Thank you.
Yes. I think 2024 saw an improvement of the funding levels in biotech. At that point in time, many companies started to think about what they could do and wanted to do with the money and which trials they would start. This has led to an uptake in RFPs, which we are not delivering upon in 2025. Therefore, our commentary that the current utilization level of our lab and smaller scale assets is good, and we have good visibility for 2025. Remember, there is always a time delay between the funding in the industry and the impact on our business. First, this is just a little bit of lab work, and only after several months, you would start to actually produce something in smaller scale assets. This is what we are seeing now.
We're seeing basically the impact of positive 2024 signing for this type of business and also late 2024 signing. The signing today, I think, are still at good levels. I wouldn't say that they're increasing, but I think the signings also in Q1 were actually okay.
The next question comes from Charles Pitman-King from Barclays. Please go ahead.
Hi. Thanks so much for taking my questions. Just two from me. Firstly, just on the signed equipment delivery slippage, I'm just wondering if you can give us any more detail around kind of who the supplier was for that equipment and how confident you are that this is just a one-off delay and this will therefore remain only a small slippage in impact, as you've highlighted.
And then just secondly, in terms of the CNHI expectation for development, can you just give us a little bit more to think about in terms of what would be the correct timeline to dispose of this business and whether or not the current market volatility and policy uncertainty precludes this potentially occurring near term? Thank you.
Thank you, Charles. I think on Stein, I'm not going to go into detail of telling you who supplies what. As you can imagine, in the current environment, also with GLP-1 shortages, fill-in-finish lines are in very high demand. Therefore, I would say this is a one-off because this is about fill-in-finish lines. This does not really impact the delivery of materials for all our drug substance facilities we're building in the other key projects. Yes, this is isolated.
This is an industry issue, if I can call it this way, where these lines are just in very high demand, and so delays happen. In terms of CHI, taking your second question, I think we were clear that we were preparing for the exit of CHI during 2025. We've made good progress in terms of assigning our advisors. We're doing all the internal work that is necessary in terms of preparing the carve-out perimeter and all this work that is needed internally. The teams are appointed, etc. I think we see good progress on this. We're also very pleased with the development of the business itself, which has seen a trough in the second half of last year and is now seeing an improving trend.
As we mentioned, we are expecting the growth rate in the second half to be ahead of what you would see in the first half and ahead of what we saw in the second half of 2024. I think the timing is right, and we should be probably making progress this year, but we do not mention any more precise timeline.
The next question comes from Patrick Rafaisz from UBS. Please go ahead. Mr. Rafaisz, your line is open. You may proceed with your question.
Yes, thank you. Hi, Philip. A follow-up on the biotech funding environment and early stage. Because last time we had this scale of drop in the funding levels, Lonza was caught a bit off guard.
I'm just wondering, you have visibility until the end of the year, but to what extent do you already prepare or flexibilize your cost structure should the RFPs start to decline again next year?
Yes, Patrick. I think, as you know, we have taken action already last year, actually at the end of 2023, preparing for 2024 as we basically closed two small-scale facilities. We've done the work. I think we believe that our early-stage network is rightly sized. So far, I think with the level of demand that we see and also new RFPs that we're seeing, we're not concerned by that. However, I think it's right that we need to observe the next month and quarter. I think where we see Q1 2025 is not a bad level, actually.
It's pretty much in line with what you would have seen on average over the last five years. However, the question would be, how does Q2 and Q3 develop? I think once we see that, we can probably be clear on the outlook. For now, I think we are ready to go up or down, but we do not expect to have to go down at this point. Maybe I can ask Sandra for the last question?
Yes, sir. The last question for today's call will be from Justin Smith from Bernstein. Please go ahead.
Yes. Thanks very much for taking my question. It's just a very quick one with regards to opportunistic acquisitions of CDMO capacity. Is it fair to say you have got so much to deal with at the moment that this is probably more a story for 2026 and beyond?
Yeah.
I think, as you rightly said, this is opportunistic. If the opportunity arises, we would take the opportunity. I think we are very capable of doing the organic program that we're doing at this point and going after opportunistic acquisitions if they were to happen. Unfortunately, you cannot time such acquisitions. When we see the opportunity, we would go after it if it's the right one. We believe the Lonza engine can add value to that acquisition. Any time is the right time for the right asset. With that, thank you very much. I would like to thank you all for attending the call and for the good questions. Looking forward to talking to you again in a few months at our half-year results in July. With that, thank you very much. Goodbye, everyone.
Ladies and gentlemen, the conference is now over. Thank you for choosing , and thank you for participating in the conference. You may now disconnect your lines. Goodbye.