Fagron NV (4A5.F) Q3 FY2025 Earnings Call Transcript & Summary

Hello, and good morning, everyone. Welcome to Fagron's Third Quarter 2025 Trading Statement Webcast. I'm joined today by our CEO, Rafael Padilla; and our CFO, Karin de Jong. We will open the floor for questions at the end of the session. And with that, I will hand over to Rafael.

Thank you, Ignacio, and good morning, all. We're pleased to report a solid quarter where we achieved normalized organic growth of 8.5% and a 5.7% organic growth at CER when including the phaseout of GLP-1s. This quarter, our Wichita facility underwent a routine inspection by the FDA wherein the agency verified the corrective and preventive actions we set in place and received no repeat observations, which validates our remediation actions. Additionally, the FDA also validated the previously announced capacity expansion that is expected to generate $25 million in revenue. We also continue to execute on our M&A strategy as we announced the acquisition of UCP in the U.S., while at the same time, we have received competition clearance for Purifarma and Injeplast in Brazil. In 2025, we have already welcomed eight companies showing our M&A disciplined serial acquired profile. And to finalize, we confirm our full year guidance of EUR 930 million to EUR 950 million revenue and a slight increase in profitability year-on-year. Let us now look at the regional dynamics. In EMEA, revenue growth was driven by all segments and contributions from our recent acquisitions. B&E saw an impressive quarter as we reap the benefits of our refined commercial strategy, improved operational excellence and diversified footprint. In Compounding Services, we benefited from robust demand combined with new customer wins. In Latin America, growth remains solid with all segments contributing positively. Brands' impressive growth trend remains, reflecting the successful execution of our commercial strategy, coupled with our innovation power. Essentials continues to benefit from our market leadership position and an improvement in underlying demand. Turning to North America. B&E organic revenue growth was driven by improvements in operational excellence and new product launches benefiting on the B2A opportunity. Compounding Services demand remains strong in both health and wellness and hospital outsourcing. This was offset by the absence of GLP-1 sales and the [ IPA ] from lower output at the Wichita facility during validation of additional capacity that will generate revenues of $25 million. Finally, the Anazao facility investment in Las Vegas as well as the integration of CareFirst and BellaCorp remains on track. And in Tampa, we await California license to be able to complete the transition to the new facility. Let's now say a few words about quality. This quarter, our Wichita facility underwent an FDA routine inspection, concluding in no repeat observations, which validates our remediation actions. This year's inspection also validated the previously announced capacity expansion that will generate an additional $25 million revenue. During the routine inspection, the FDA also issued a Form 483 with 6 observations. Additionally, our Anazao's facility in Las Vegas was also inspected by the FDA, resulting in a Form 483 with 4 observations. As we repeat quarter-on-quarter, quality remains a key differentiator in our industry. With over 35 facilities to audit globally, we are constantly inspected by regulatory bodies across the world to uphold the highest quality standards. Moving on our growth strategy. We're happy to announce one more addition to the group, UCP in California, totalizing 8 so far this year. With this acquisition, we are setting up a nationwide platform to better position ourselves to capture the rapidly growing health and wellness market. UCP enhances Anazao's portfolio and footprint and has a strategic relevance as California is a market with hard to obtain licenses. We also received exciting news regarding Purifarma and Injeplast. The Brazilian Competition Authority, CADE, has granted clearance for these acquisitions. This represents an important step forward in executing our disciplined M&A strategy and will enhance our product portfolio and local capabilities in Brazil. The acquisitions are subject to closing conditions and completion of certain local corporate and contractual formalities. The important bit is that with regulatory clearance, we have certainty of closing both deals. Again, so far this year, we have made eight acquisitions following a serial disciplined acquired M&A approach focused on market consolidation, enhancing our product capabilities and geographical expansion around the globe. This showcases our strong momentum. Moving to our full year guidance. We are confirming our revenue guidance to a range of EUR 930 million to EUR 950 million, while confirming a slight improvement in profitability year-on-year. CapEx will remain around 3.5% of revenues, excluding one-off projects already announced. To conclude, Fagron is the only global vertically integrated niche defensive, high cash generating company operating in the pharmaceutical compounding fragmented market. Our resilient business model is fortified by a diverse geographical footprint. These factors, coupled with demographic trends and our emphasis on personalization are the basis of our success. Our quality focus, together with our ongoing operational excellence initiatives will optimize our business through global synergies while a disciplined serial acquired M&A strategy remains a key part of our growth. Sustainability is a paramount priority and a strategic cornerstone for us, as together, we create the future of personalizing medicine. Let's open the floor now for questions. Thank you.

I will -- our first question comes from Stijn Demeester from ING.

Two questions, if I may. First one is on the U.S. Compounding business. It seems that the broader market in North America is still focused on GLP-1s, even though the FDA has removed semaglutide from the list from the shortage list. Even a listed company like Hims & Hers seems to continue to offer GLP-1-like formulations. Question here is, how do you explain the situation? How long do you believe it can last as it does seem to impact your business adversely? And second question on Purifarma. In the press release of earlier this week, you mentioned that the scale up of the Brazilian operation is expected to generate procurement benefits, not only across Latin America, but also in the entire global footprint. Can you maybe elaborate on this in the light of the FDA approval for your Sao Paulo facility, which apparently opens up an export route into North America? Yes, it could be helpful to get an idea to what extent this can benefit your group operations.

Thanks a lot. Great questions. On the first one, on GLP-1, of course, we can't comment on our own activities. And as you know, very well, on May 22, the GLP-1 or semaglutide was out of the shortage list. So we stopped compounding. In the current framework, what we see is that on the 503A with a clinical difference statement. So it's in each script, a statement on each script a script could be compounded. Of course, as you can understand, this is not so much convenient for doctors to fill in a form. So this is our current view on it. And when it was commented on the impact, when we see the underlying trend of the health and wellness market in this case, so that's especially for us Anazao, we see that even without the GLP-1s, we have set a nice quarter year-to-date as well. And also as we move to the new Tampa facility, we have been operating onto. So we expect the California license for the Tampa facility to have a completion of the move. Then on the second one, Purifarma, indeed, Purifarma, as we have commented previously, has a strong portfolio in essentials, so 300 items with huge volumes. If you remember, Stijn, we explained that the Purifarma facility, it's 500 meters, so 10 minutes walking out from ours in Anápolis, that's close to Brasilia in the center of the country. And of course, that was part of our plan that we explained some months ago, 9 months ago. We explained that we're going to integrate Purifarma activities into Fagron Services Brazil activities. Remember that the Fagron Services factory was built in 2022 with the idea with the vision at that time to have a huge facility to cover the whole Brazilian market. And therefore, we're going to absorb without any single problem, all those volumes. Of course, as you said, we're going to leverage volumes of those essentials throughout our global network. So as you know, we have now a robust procurement network, Vera explained that very well during our Capital Markets Day. So we'll see impact on the savings. We have a 3% target till 2027, as Vera explained during April 10. And next to that, this will give, of course, units to have a better cost price in the units we make. So we are going to have better cost pricing also for the goods that go into the U.S. Thanks a lot, Stijn.

Our next question comes from Frank Claassen from Degroof Petercam.

Yes, Frank Claassen from Degroof Petercam. Two questions. First of all, on EMEA, there was quite a strong growth acceleration in the quarter. Could you elaborate what drove that acceleration? And also, is this growth rate -- new growth rate sustainable going forward? So that is the first question. And the second question on Wichita. You had a lower output due to productivity improvement program or at least the capacity expansion. Could you indicate how much revenues impact that had in Q3? And will it be gone in Q4? And when will the EUR 25 million revenue capacity kick in? Will that already be as of Q4? Some explanation on that, please.

Thanks a lot, Frank. On EMEA, indeed, we have seen a strong quarter. As we commented previously, we see a pickup in the underlying market demand. There are clear tailwinds as aging population, prevention and lifestyle. We see that kicking in also in the European landscape, which benefits us a lot. And this together, when you remember, Frank, we explained some years ago that we had a clear strategy for Europe with two pillars. One was the diversification of the Benelux. We were heavy lifted at that time in the Benelux. Now of course, Netherlands and Belgium is important, which they perform very good. We have also started activities in other countries. So this helps. And the second pillar is, of course, our operational excellence programs with our Polish facility. Of course, availability goes up, were explained during our Capital Markets Day, our product availability at 95%. In Europe, we're already at 93%. So this has been a major step, and this helps on the development.

Frank, and to come back on your question on the growth rate of EMEA. So indeed, they had a very strong quarter with 7.8% growth. We don't expect that level in the fourth quarter. However, we are very positive about that EMEA region. So for the full year, we expect a low single-digit to mid-single-digit percentage of top line growth, and that is also in line with our midterm targets. Then on the second question on the Wichita facility, at FSS, we had a growth in the third quarter of 6%, which was indeed driven by a temporary lower production output due to the validation of the new production room. The impact is difficult to quantify as we have some spillover in the fourth quarter and some losses. We have relatively good visibility on the fourth quarter, and we expect a good quarter. So year-to-date, we're at 15.9%. And for the year, we expect North America to have a high single-digit to low double-digit percentage of growth. Market drivers are strong, and we are well positioned. So we are very positive about the midterm perspectives of this overall market.

Okay. And the EUR 25 million revenue capacity, when will that be operational?

Yes. So the site is operational, so we can use that site for our production. So we can benefit from that capacity expansion. Currently, we're already benefiting from that.

Yes. And adding here, Frank. Yes. And adding -- quickly adding here, Frank, on this capacity expansion that Karin explained very well. This helps us to bridge for the next year. And remember that in 2027, the E2 project that was explained also during our CMD is coming online. So this new capacity that you were referring will help us for 2026.

Our next question comes from Michael Heider from Berenberg.

I have only a few more general questions left because on the quarter, your answers have already been given. But could you maybe elaborate a bit on your acquisitions going forward? I mean, do you have more in the pipeline for '25 or certainly probably '26? And then maybe can you remind me of the additional CapEx because you said your target is 3.5% of revenues. Excluding additional CapEx, so what is the target for '25 and '26? And then last question is on your net debt-to-EBITDA ratio. What do you expect here for 2025 and in the midterm?

Yes, Michael, maybe starting with your M&A question. So we have a disciplined approach to M&A, and we have a full pipeline of targets, which means that we have targets in all regions. We executed well this year. We've done eight, as you've read in the press release. So we're well on the track, but we see opportunities -- more opportunities in the different regions. So that is EMEA as well as North America, but also Latin America. We're also looking at APAC, as we announced during our Capital Markets Day. So we are very positive about our M&A momentum currently, but of course, with a disciplined approach. On timing on deals, that's very difficult to estimate. We do midsized deals, usually family-owned companies. So from that perspective, it's difficult to give any guidance on our M&A, but we are progressing well, and we anticipate doing more deals this year and next year. So maybe on your second question on CapEx. So indeed, maintenance CapEx is 3.5% of sales. That's our estimation also for the midterm. If we look at expansion CapEx related to our new projects, we announced a couple. I think the big one is the expansion we have in Wichita. So that is a big one that we announced, and that's EUR 35 million -- EUR 39 million, sorry, which will be in the next coming years. So part of this, this year, most of that will be spent next year and we go live in 2027. And then we have an expansion in Vegas, which we also announced, which is EUR 29 million, which will mostly be next year when we spend that money. And then for the EMEA region, we also announced an expansion for a sterile facility in the Netherlands, which is EUR 15 million. So those are on top of the 3.5%. On our net debt -- maybe the last question on our net debt to EBITDA. So we are -- at the end of last year, we were at 1.4x. We have strong cash generation, as you know, depends a bit on the timing of certain payments and also the closing of the acquisition we have announced. So we expects to move a bit more towards the 2, but it stays well bit below our boundaries and our internal threshold of 2.8x. So we have sufficient room to do additional acquisitions this year, but also the coming years. Thank you very much for your questions, Michael.

Our next question comes from Usama Tariq from ABN AMRO - ODDO BHF.

I just had one question because others were already answered. Could you just comment on the market share per region, specifically in North America? So has there been any market share loss because of production halt or anything like that?

Yes. Thank you, Usama. On the market share in the U.S., if you remember, we have 3 segments in the U.S. That's the Brands and Essentials around 30%. We are now #2 behind Medisca, which is a market leader there. Think about 15%, 18% of the total market on B&E, its accounts to us. Then when we go to the Compounding Services, we have 2 verticals. We have the health and wellness, that's Anazao with the Tampa facility, the new one, of course, we have Vegas, 503B that we're expanding. We have CareFirst in the Northeast, and now we have UCP. So as we were explaining, we have a nationwide platform now for this segment is a rapidly growing segment. And here, we're also #2 behind Belmar. It's a great company. And we could say it's around 10% to 12% of the market. And then going to the hospital outsourcing, that's FSS, where we have Wichita, of course, the current one and the new one that we are building across the street, that's E2. And then we have, of course, Boston. And here, we are as well #2 behind QuVa. Here, revenues would account as well for 15% of the total market. And when you refer to the Q3, the slowdown in the production that was due to as Karin explained it very well, validation of the new capacity that we have added that was wall-to-wall. We have not lost any single market share. The opposite. As you have seen, we have been growing also during the quarter, 6%, and that's a combination, of course, of current customers and new customers. We onboard new customers year-on-year. We also have completed nice deals with some GPOs as well. And you can see them back in the -- at our LinkedIn accounts. And of course, we need to understand that when we have this capacity added wall-to-wall, there is no production on hold, not at all. It is in a slowdown because you do it in phases. You need to validate this new production area. So this meaning that there is output, however, at a lower pace. And again, I repeat myself, we have had a nice growth of 6%, totalizing 15.9% year-to-date, and the beauty is that, of course, FSS, the hospital outsourcing, we have contracts. So we have visibility and Q4 will be strong, and we'll have, again, a record year. So thanks a lot to Usama for your question. And if you want us to comment on the market share on the other 2 regions, LATAM and EMEA, also super happy to do so.

No, I think that will be sufficient. It was more with regards to North America.

Thanks a lot, Usama.

It appears that was our last question. I will now hand the word back over to Ignacio Artola for any closing remarks.

Well, thank you very much for your participation today. I will remain at your disposal should you have any further questions. Thank you very much, and goodbye.