Grifols - Earnings Call - Q1 2025

Transcript

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Hello everyone. My name is Dani Segarra, and I serve as the Head of Investor Relations and Sustainability and Vice President at Grifols. Welcome to our review of the company's business results for the first quarter of 2025. Today, I'm joined by Grifols Chief Executive Officer, Nacho Abia, Chief Financial Officer, Rahul Srinivasan, and the President of Biopharma, Roland Wandeler. A few logistics before we get into details. Today's call will last about an hour, including a Q&A session. As a reminder, this call is being recorded. You can find additional materials, including today's presentation, in the Investor Relations section of the Grifols website at grifols.com. The transcript and a replay of the webcast will also be available on the Investor Relations website within 24 hours.

Turning to slide two, please note that this presentation includes forward-looking statements regarding, among other things, the company's future operating and financial performance, market position, and business strategy. These statements are based on current expectations and available information as of the date of this recording, and they are subject to certain risks and uncertainties that may cause actual results to differ materially from those projected. Grifols' financial statements are prepared in accordance with EU, IFRS, and other applicable reporting provisions, including Alternative Performance Measures, or APMs, prepared under the Group's Financial Reporting Model as defined by the European Securities and Markets Authority. Please note that Grifols Management uses APMs to evaluate financial performance, cash flows, and overall financial position as the basis for operational and strategic decision-making. These APMs are prepared for all time periods presented in this document.

Now, moving to today's agenda, Nacho will start with some introductory remarks, followed by a discussion of our business performance and strategic execution. Then, Rahul will review the financial results for Q1 2025. After Rahul's presentation, we will return to Nacho for his closing comments. Roland will be joining us for Q&A. With that, I will now turn the call over to Nacho. Nacho.

Nacho Abia (CEO)

Thank you, Dani, and thank you, everyone, for joining us today. Building on the all-time high in 2024, we are pleased to report a strong start to 2025. The first quarter saw encouraging increases in revenue, EBITDA, and free cash flow. This performance reflects the fundamentals of our business and the continued execution of our strategic plan. We recognize that this growth is particularly noteworthy given the anticipated impact of the Inflation Reduction Act, IRA, and the global uncertainties we all are navigating. Despite these factors, our Q1 results across the board are ahead of our plan and, importantly, provide a solid foundation for continued progress throughout the year. Although the first quarter has traditionally been our softest, our Q1 performance reinforces our confidence that we will continue to see steady improvements over the course of 2025, similar to the pattern we observed last year.

I will walk you through these drivers in the next slides to give you more clarity about how we plan to achieve it. Before we delve into the details of the quarter, I would like to briefly highlight that in recent weeks, we have been closely monitoring the increasing macroeconomic and policy development that is affecting all market participants. While we strongly believe we are well prepared to navigate these dynamic market conditions without meaningful impact, we remain vigilant and continue to carefully evaluate the situation. We will share as well more insights on this throughout the presentations. Ultimately, our focus remains firmly on executing our strategy, staying true to our mission and vision, and delivering on our performance goals. I want to express my sincere appreciation for the dedication of our teams across the globe.

Their commitment to driving our strategy forward and serving donors and patients worldwide has been critical to our positive start to 2025. With that, let's move to the first quarter results in slide five. Before I go through this slide, it is important to note that in order to provide the market with a clearer view of the underlying performance of Grifols and Biopharma in particular, we are presenting key financial metrics for this quarter and for the remainder of the year in two ways: reported and like-for-like. Like-for-like figures are adjusted to account for the impact of the IRA Part D redesign and the fee-for-service reclassification. As a reminder, in Q4 2024, we changed the treatment of our U.S. fee-for-service and GPO fees. These fees are now accounted for in our gross-to-net sales rather than in OPEX, which has no impact on EBITDA.

The full 2024 impact of this change was reflected in Q4 2024, and as a result, it distorts the biopharma revenue growth in our 2025 quarterly results. In Q1 of this year, the difference between our like-for-like and reported figures amounted to EUR 43 million. Of this, EUR 28 million was attributable to the IRA, in line with our forecast, while EUR 15 million was related to the fee-for-service reclassification. Revenue in the quarter was a key highlight, reaching EUR 1,786 million, a 7.4% increase on a constant currency basis. On a like-for-like basis, revenue increased by 10%, showing a clear continuation of the positive revenue growth trend we saw in 2024. Adjusted EBITDA for the quarter reached EUR 400 million, an improvement of 14.2% at cost and currency. Like-for-like, it grew by close to 22%.

The IRA impact, along with some temporary phasing in albumin and rabies, put some pressure on our gross margin and EBITDA in Q1 2025. Going forward, we remain confident of our continuous improvement of our margins throughout the year, following the same pattern as in previous periods. Free cash flow for the quarter was EUR 44 million, primarily due to the payment to Immunotech for EUR 79 million, as previously disclosed. While free cash flow was negative this quarter, we achieved a year-on-year over-improvement of more than EUR 200 million. Considering our first quarter performance, we see these as clear signals for continued upward momentum in top-line growth, profitability, and free cash flow generation, while we maintain our strong commitment to further leveraging our balance sheet.

In terms of guidance, we are forecasting sustained revenue growth throughout the year, driven by our immunoglobulin franchise, with significant growth in the U.S. as well as outside the U.S. We expect our subcutaneous immunoglobulin to continue gaining traction and contributing to the product mix. Our revenue projections are also supported by the improved performance of rabies and albumin, as the phasing reporting in Q1 2025 will not carry into subsequent quarters. We also see our Alpha-1 franchise continuing to show positive momentum following a new specialty pharmacy partnership in the United States. Equally important will be the contribution of lower cost of goods, as the cost-per-liter initiatives and the yield improvement efforts have been delivering and improving our inventory cost. Additionally, as revenue increases throughout the year, it will trigger a higher absorption of operating expenses, thus having a significant positive impact on our EBITDA.

Finally, let me emphasize that this business momentum is not only reflected in the quarter's positive results, but also underpinned by increased plasma capabilities and efficiencies, along with the successful completion of key innovation milestones, including fibrinogen, which we expect to launch in Q4 2025 in Europe and in the first half of 2026 in the United States, following its FDA approval. With that, I will turn to the top-line comments in slide six. Year-to-date revenue increased by 7.4% on a constant currency basis, driven by robust performance across all business units. Excluding the impact of the IRA and the reclassification of our fee-for-services, revenue grew by 10%. The sustained momentum was primarily fueled by biopharma, which like-for-like grew by 9.6% on a constant currency. The Immunoglobulin franchise continued to be the cornerstone of our growth strategy, achieving 17.5% growth in revenue at cost and currency and like-for-like.

This growth was led by IB and subcutaneous IG, as I will explain in a second. Alpha-1 continued to improve in Q1, reversing the challenges faced in prior quarters when the company switched its U.S. Alpha-1 major distributor. While biopharma posted a strong overall performance, it was partially offset by some phasing in albumin and rabies. Albumin was impacted during the quarter by a standard license renewal process in China, which has been successfully completed, allowing for the resumption of shipment as planned. The diagnostic business achieved a 5.2% increase in revenue on a constant currency basis this quarter due to a broad expansion across both core and non-core markets, as well as strong joint business volume growth. Key segments, including molecular donor screening, immunocyte donor screening, and blood typing solution, each grew by 7%, 12%, and 4% respectively, all on a constant currency basis.

As I previously mentioned, biopharma continued to be the main growth driver in the first quarter of the year. The IG franchise remains the leading growth protein. IG growth was fueled by strong demand in both U.S. and international markets, while subcutaneous IG continues to gain momentum, growing an impressive 91% at cost and currency, driven by higher demand across all key regions. As mentioned, albumin sales growth was temporarily affected due to the manufacturing license renewal process in China. This resulted in a decline of 8.9% on a like-for-like basis and 9.4% on a reported basis. As said, the renewal process has been successfully completed, and accordingly, we expect stronger albumin revenue performance in the upcoming quarters. Albumin remains a key component of our portfolio, and we expect to continue to leverage our partnership in China with Shanghai RAAS and Haier to continue strengthening our position.

Alpha-1 and specialty proteins revenue growth improved by 2.3% at constant currency, and like-for-like compared to the previous year. This growth was driven by Alpha-1, continuing the traction seen in the last quarters, although it was partially offset by the phasing of demand for rabies treatment, which, as already mentioned, will reverse in Q2 2025. Turning to the next slide, I'll take a closer look at the performance and outlook for our IG franchise. As we highlighted during our Capital Markets Day, immunoglobulin remains the cornerstone of our biopharma business, driven by its status as our highest growth protein. This is evidenced by the strong underlying demand for both intravenous and subcutaneous therapies. Our strong growth and solid market positions have enabled us to capitalize on several favorable market trends, including increased awareness of immune-related diseases, rising diagnosing rates, and the ongoing expansion of both secondary and primary immunodeficiencies.

Additionally, the continuous development of therapeutic solutions in areas like neurological diseases presents further opportunities for growth. We remain focused on executing the strategy outlined for biopharma, building on our leading brands, accelerating the diagnosis rate, and solidifying our leadership position in the market on the back of increasing global demand for the treatment of immunodeficiencies, followed by steady increases in albumin and Alpha-1 antitrypsin and other specialty plasma-derived therapies. Let me discuss now our situation regarding recent tariff developments and our confidence that previous and step investments protect us well in the current environment and the latest developments in U.S. drug pricing policy. For decades, Grifols has developed a diversified global footprint of plasma donor centers, manufacturing facilities, and distribution hubs across key geographies, ensuring we are strategically located to serve patients where they need us.

Our growth strategy has been investing in regional end-to-end capabilities that allow us to adapt the process in response to evolving global demand. This vertically integrated and cross-licensed structure provides valuable flexibility and optionality to meet global needs with minimal disruption, while significantly mitigating uncertainty from potential tariff impacts. In the U.S., our comprehensive end-to-end supply chain is a key strength. Plasma collected at over 300 U.S. donor centers accounts for approximately 70% of our global plasma supply. This is then processed at our fractionation and purification facilities in Clayton, North Carolina, and Los Angeles, California, which together represents about 65% of our global capacity in these critical areas. This alignment between our U.S. collection and manufacturing operations minimizes reliance on external sourcing and allows for agile responses to changing needs.

Our presence in Europe and the Middle East is also significant, with nearly 100 plasma collection centers, paired with our manufacturing facilities in Spain, Germany, and Ireland. Our European plasma collection network, the largest privately owned fleet, coupled with our expansion in Egypt, positions us well to serve increasing demand outside of the US. Consistent with our global strategy, we continue to invest in local partnerships that directly address regional needs. In China, our long-standing strategic partnership with Shanghai RAAS and Haier, combined with our European manufacturing capabilities, enables us to leverage a local presence and respond swiftly to regulatory developments. In Egypt and Canada, we are investing in greater self-sufficient partnerships with the Egyptian government and Canadian Blood Services, respectively. In both countries, we are establishing donor centers and manufacturing capabilities to support local healthcare ecosystems for the long term.

This established global network of donor centers, manufacturing, testing sites, and distribution channels provides Grifols with a degree of resilience across core borders, microeconomic, political, and environmental uncertainty, including tariffs. To reiterate, we do not anticipate any meaningful impact to our business due to tariffs, as we believe this strategic approach has positioned us well to effectively serve patients globally and navigate the evolving geopolitical and fast-changing landscape. Since the early 2000s, recognizing the scale and importance of the U.S. market, we began strategic investments, starting with the acquisition of plasma centers and manufacturing assets, establishing our presence as a U.S. manufacturer. In 2011, we expanded further with the acquisition of Talecris in North Carolina, and we have since grown our plasma collection network through acquisition and organic investments.

At the same time, we are strengthening our European footprint by expanding manufacturing in Spain and increasing our capacity for fractionation, immunoglobulin, Alpha-1, and albumin purification. We also expanded our European plasma center network, primarily in Germany, through joint ventures and organic growth. This was further consolidated with manufacturing operations in Ireland and the acquisition of a majority stake in Biotest in Germany. In 2019 and 2020, Grifols pioneered local partnership models in emerging markets. We deepened our presence in China through a strategic alliance with Shanghai RAAS and launched self-sufficiency initiatives in Egypt and Canada. In both countries, we are building plasma collection and manufacturing capabilities to meet local demand. Together, this investment set the foundation for our next phase of growth and innovation, positioning Grifols to continue benefiting patients both in the U.S. and internationally.

Finally, earlier today, the U.S. administration announced its intention to reintroduce a most favored nation MFN policy, which aims to align U.S. and ex-U.S. drug prices. While this is a recent announcement and we do not have all the details, there are some observations I would like you to consider at this point. First, plasma-derived therapies are different than regular drugs in its cost structure. We saw that this was recognized in the past in the U.S., as they were excluded, for example, from IRA direct price negotiation, and as well as in the first proposal of the MFN, where IG was explicitly excluded. We will continue to educate policymakers on the importance of access to plasma-derived therapies for U.S. patients.

With respect to global pricing, price points for plasma-derived therapies are much closer than for many other pharmaceuticals, and part of the limited price difference is due to the higher cost of U.S. plasma compared to other markets. Finally, we have a diversified product portfolio and offering across different markets, which further helps us to mitigate any potential impact. In any case, we will closely monitor the developments and share any relevant updates in our forthcoming quarterly calls. With that, I will turn it over to Rahul, who will walk us through our financial results. Thank you.

Rahul Srinivasan (CFO)

Thank you, Nacho. Indeed, we have highly dynamic forces impacting markets. Equally, as you say, we are very fortunate to have a business that benefits from significant strategic flexibility and optionality that allows us to navigate these highly dynamic markets very well.

Notwithstanding the backdrop, the entire Grifols team has been resolutely focused on execution and executing well, and thereby delivering for our patients and our customers. In doing so, we remain on course to continue our record financial performances of 2023 and 2024 into 2025, having delivered in Q1 2025 the best Q1 in Grifols' history. Moving on to page 12 for the more detailed picture. Our Q1 numbers are ahead of plan across the board, beating revenues, EBITDA, free cash flow, margins, and leverage. As Q1 is our seasonally weakest quarter, we thought that the relative performance to our internal plan for the year would be helpful to the market. I also want to make it clear that we will not be making reference to our plan or the relative performance on any of our subsequent quarter calls.

In addition, and as we did with our approach to laying out our full year 2025 guidance and the impact of Part D redesign within the Inflation Reduction Act during our Capital Markets Day, we are disclosing both our reported numbers as well as like-for-like numbers that allow the market to track more easily our underlying performance and momentum versus 2024, given the impact of IRA, and as you will recall, the gross-to-net reclassification that we made in Q4 last year. Reported revenue for the quarter grew by 7.4% and by 10% like-for-like, both on a constant currency basis. Reported Q1 gross profit margins were higher than Q1 2024, despite the impact of the IRA and the fee for service reclassification. The corresponding like-for-like margin improvement of 150 basis points clearly shows the continuing gross margin improvement potential.

Reported adjusted EBITDA was up by 14.2% on a constant currency basis, and adjusted EBITDA margins improved by 80 basis points to 22.4% on a year-on-year basis and considerably higher on a like-for-like basis. Profit before tax and group profit are up by 145% and 179%, respectively. Free cash flow pre-M&A had a year-on-year improvement of EUR 209 million, and I will elaborate on the drivers of this considerable improvement further in the presentation. Unlike prior years where leverage tended to increase in Q1, we were able to de-lever in Q1 2025, and more on that later in the presentation. Finally, liquidity continues to be in a very robust place at EUR 1.7 billion. All in all, a strong performance across the board delivered Grifols' best Q1 performance ever. Slide 13.

Having hit a revenue and earnings trough post-COVID, Grifols has delivered very strong and consistent growth across revenues and earnings. Indeed, the last two years have delivered record revenues and EBITDA, and Grifols very much remains on course to beat those records again in 2025. The rapid growth of revenues, adjusted EBITDA, and reported EBITDA quarter-on-quarter is evidence of the secular growth in biopharma and our strong position in this attractive market. We at Grifols are particularly proud of the sequential improvement in LTM margins, be it adjusted EBITDA or reported EBITDA margins, and as a team, we remain very focused on executing well and thereby continuing this trajectory for the quarters, if not years to come.

In particular, the 430 basis points improvement in LTM reported EBITDA margin and an almost EUR 500 million increase in LTM reported EBITDA from circa EUR 1.2 billion to EUR 1.7 billion in just six quarters speaks to the normalizing earnings profile after the impact of a once-in-a-hundred-year pandemic event and the clear reduction in one-off non-recurring costs, as well as the continued and rapid convergence of reported EBITDA to adjusted EBITDA. If you look at page 26 in the annex, you can see further evidence of this convergence as the delta between adjusted EBITDA and reported EBITDA margin more than halved in Q1 2025 versus Q1 2024. Indeed, if you look at the two EBITDA charts on slide 13, it clearly shows that reported EBITDA lags adjusted EBITDA by only two quarters, providing clear evidence that adjusted EBITDA is a very good proxy for Grifols' very near-term cash EBITDA potential. Slide 14.

Adjusted EBITDA in Q1 2025 grew by 14.3% year-on-year. Just to contextualize that performance, EBITDA is growing almost twice as fast as revenues, as has been the case in 2023 and 2024, and depending on which end of the guidance range you use, our EBITDA is growing almost twice as fast as the growth implied by our EBITDA guidance for 2025, which, as you will recall, is on a post-IRA basis. Our reference to the Q1 performance being ahead of plan probably will not come as a surprise to the market. Despite the circa 140 basis points negative impact on our margins from IRA, we delivered a year-on-year adjusted EBITDA margin improvement of 80 basis points in Q1 2025.

I will not belabor the even more impressive stats of the like-for-like adjusted EBITDA performance as we absorb the IRA impact, but it certainly should give the market an appreciation for the underlying demand and the secular growth tailwinds led by our biopharma business. It was particularly pleasing to see that revenue and earnings growth across all segments, including the strong revenue and EBITDA momentum that we are observing in our diagnostics business. On the biopharma side, the growth drivers of the strong performance in the quarter are consistent with our observations in prior calls: strong, diversified growth across regions in IG, both U.S. and ex-U.S., that, as you heard from Nacho, is clearly outpacing the market. Due to the planned phasing impact as a result of our albumin license renewal in China, we would expect stronger albumin revenues in the upcoming quarters.

Same holds true of Alpha-1 and other proteins, particularly if we take into account the seasonal demand for our rabies product. We continue to squeeze CPL with lots of focus from the team on efficiency gains, and we remain encouraged about the outlook. Speaking of efficiency gains, the team is excited about the manufacturing yield improvement potential, as well as moving the mindset to a cost per gram of protein and not simply cost per liter. Finally, ensuring we capture as fully as possible the operational leverage improvement potential that comes with the strong growth prospects whilst maintaining tight cost discipline. The last point I'd like to flag on this slide is the IRA adjustment. The EUR 28 million was our accrual for Q1.

We have had the benefit of receiving our first invoice, and it was in line with our expectation, giving us confidence that the EUR 125 million midpoint of our range remains a prudent estimate. Slide 15. An update on our free cash flow generation improvement efforts. As a reminder, following our significant outperformance of free cash flow generation in 2024 versus prior guidance, we laid out much more detail around our prioritization of free cash flow generation as part of our strategic plan.

The significant EUR 209 million free cash flow improvement in Q1 2025 versus Q1 2024 is further tangible evidence that the result from Q4 2024 was not a flash in the pan, but that this business can absolutely produce significant free cash flow as the effects of the COVID period recede further and further into our rearview mirrors. We expect to be able to continue to demonstrate strong momentum in free cash flow generation in the quarters and years ahead. This EUR 209 million year-on-year improvement credibly underpins our free cash flow guidance for 2025. Also, I wanted to touch on why Q1 tends to be our weakest free cash flow quarter. It is for two principal reasons. Firstly, it is our weakest EBITDA quarter, partly due to seasonality, and it tends to be sandwiched between two relatively strong quarters.

This is the quarter when the bonus payment for the year is made. Working capital management continues to be at the heart of our free cash flow improvement. Our inventory days in Q1 2024 were unnaturally high, but Q1 2025 continues the trend of the last four quarters. As we guided to during our capital markets day, I do expect us to invest more capital to bolster our inventory position further, given the strong demand that we continue to see, but we will continue to manage that tension diligently. Our receivable and payable days are settling down or normalizing, if you will, and continue to be in line with the last couple of quarters.

The other notable part of our improved free cash flow generation is more EBITDA, further benefited by less cash adjustments as the effects of restructuring and transaction costs begin to dissipate, as we have guided to previously. Finally, for the eagle-eyed amongst you, the phasing impact of interest and CapEx offset each other in Q1 2025, so this EUR 209 million year-on-year improvement is not simply down to timing or phasing differences, but it is real improvement. Slide 16. As our free cash flow generation story normalizes, it also helps our deleveraging profile. In prior years, Grifols' leverage typically increased in Q1 by up to half a turn or so.

In contrast, due to the normalizing of our free cash flow story, as evidenced by the sequential improvement you see on the chart on the right and continued strong year-on-year EBITDA growth, instead of leverage going up meaningfully in Q1, we have in fact de-levered slightly from 4.6 times to under 4.5 times. This de-leveraging focus will remain a clear priority for us. Aside from the positive de-leveraging, I continue to feel very good about the state of our balance sheet. We have strong EUR 1.7 billion of liquidity. We have a lot of rainy day secured capacity if we ever need it. We have no meaningful maturities till Q4 2027. We have a very encouraging rate outlook supporting our refinancing plans in Q2 or Q3 2026.

The private placements we placed around six months ago are yielding meaningfully less than they were issued at, which suggests that our credit re-rating focus continues to gather momentum. In summary, all progressing very positively on this front too. Slide 17. At a time of significant change from a global macroeconomic perspective, to be able to provide the market with the confident message that we are providing today is helped significantly by Grifols' legacy and its pioneering spirit that has allowed us to be at the forefront of this attractive market. For many years, indeed decades, as Nacho mentioned, before us, Grifols has developed a global yet very local strategy, essentially an in-market, for-market, vertically integrated strategy and pioneering various regions' self-sufficiency aspirations, and with it, highly critical regional partnerships.

That gives us today a highly strategic portfolio with somewhat unique optionality and flexibility to be able to effectively navigate all the changes that are upending global markets and global supply chains, and also be in a position to capitalize on opportunities that these potential changes might create. Clearly, this remains a fluid situation, but our assessment is that we are navigating these changes from a position of strength, and we will continue to monitor the detail closely and adapt if we need to, even if for the moment our assessment is that we are not expecting any meaningful negative impact on our business. With respect to euro dollar, critically, a depreciating U.S. dollar is broadly neutral to positive from a group profit, leverage, and free cash flow standpoint. This is as a result of the natural hedges embedded in our business model.

For example, a significant proportion of our COGS, our OpEx, our CapEx, our inventory, our debt are all U.S. dollar denominated. Yes, a structurally weaker dollar does pose a headwind in absolute revenues and EBITDA, even if it is positive from a margin standpoint. In summary, we are not overly concerned about a depreciating U.S. dollar. As a result of the strong momentum and outlook that Nacho and I have talked about, notwithstanding the macroeconomic backdrop, we reaffirm our 2025 guidance, and we remain on course to deliver a third consecutive record year in 2025. Finally, on Biotest, the delisting offer has been approved by BaFin, and the offer period runs through till early June, and therefore we are progressing as planned with this offer being financed from existing resources consistent with the capital allocation framework we presented at our capital markets day.

With that, let me hand it back to Nacho for his concluding remarks.

Nacho Abia (CEO)

Thanks, Rahul. I would like to conclude this call reiterating a few points that we have already made, but I think it's worth repeating. The first quarter of 2025 builds upon the strong momentum achieved in 2024, laying a solid foundation for the remainder of the year and demonstrating the operational resilience of the organization. Even in dynamic markets, we're executing the roadmap outlined in our strategic plan, and that roadmap is delivering results. Improving free cash flow generation and continuing to deliver remain top priorities for the company. These are not merely financial objectives; they are central to our strategy. We are seeing tangible progress and will continue to embed financial discipline across the company.

These financial improvements cannot be achieved without the substantial progress we have made in operational excellence and R&D, which continue to be the key drivers of profitability and sustained performance. As part of the execution of our strategic plan, we are also advancing our initiatives around corporate simplification and portfolio optimization. These efforts are progressing and are critical to unlocking operational efficiencies and sharpening our focus on the core areas where we can lead and win. We are committed to building a simpler, more agile, and more focused organization that is best positioned to capture opportunities and respond swiftly to evolving market dynamics. At the same time, our regional business model continues to provide a strong buffer against global uncertainty. By sourcing, manufacturing, and distributing locally, we maintain a structural advantage in navigating tariffs and other external pressures across different markets.

Finally, as we look ahead, the entire executive team, as well as the entire organization, are focused on accelerating the execution of the company's operating plan, on operational excellence, on cash flow improvements, and debt reduction, and ultimately on increasing value for all shareholders. The foundation is solid, and the opportunity in front of us is nothing short of outstanding. Thank you again for your continued support. With that, Dani, back to you.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Thank you, Nacho. Now let's turn to the Q&A session. Please remember to press Star five to ask a question. We need to place a limit of two questions per analyst. If you have follow-ups, please dial Star five again to get back on the list. After you ask your question, we will put you on mute to reduce any background noise.

If I'm not wrong, I think that our first question is coming from Charles Pitman from Barclays. Charles.

Charles Pitman (VP and Equity Research Analyst)

Hi guys, thanks so much for taking my questions. Two, if I may. Just firstly, to your point about viewing Grifols' business structure as protected from ongoing U.S. policy discussions, I was just wondering if you could give us a little bit more transparency around what Grifols' exposure is and what the split is across Medicare Part B, D, and Medicaid, just to kind of give us a little bit more to work with when considering these potential impacts, regardless of whether or not it then turns out the plasma-derived therapies are excluded.

Then just secondly, with regards to the albumin phasing noted in the release today, I was wondering if you could provide a little bit more detail on what the implied underlying growth looks like in this market, excluding the disruption, and what kind of led to the unexpected delay given this risk was not flagged ahead of results? Effectively, just any more confidence you can give us on the strength of the albumin market generally. Thank you.

Nacho Abia (CEO)

Thank you, Charles. This is Nacho. On your first question, honestly speaking, I think that it is really too early to make any conclusion whatsoever. I think that for the reasons I explained previously in my presentation, I believe that we are well positioned to face whatever will come in the most favored nation, but we have to see the details of that and how this unfolds.

On the tariffs, I think that I also made clear that our presence in the U.S. is very solid and essentially self-sufficient there, so we do not see at this point any impact as well on that front. That is what I can say on the first point. On the second point, I mean, the albumin license renewal is something that was planned, is something that happens every certain time, and this does not change our goals for the year. Our goals for the year are that we plan to grow albumin by 5%-6%, and we continue on that path after the resumption of the shipments, after the license approval. Thank you, Charles. Thank you, Lou.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Thank you, Nacho. Now, I mean, I will ask Jaime from Santander, Jaime Escribano.

Jaime Escribano (Head of Iberian Small&Mid Caps)

Hi, good afternoon. A couple of questions from my side.

The first one would be, when do you expect revenues coming from Canada? Are you already making revenues in the new facility there, or what is the roadmap? That would be one question. The second question would be regarding fibrinogen. Do you produce the fibrinogen in Europe, or is it Biotest, or are you going to produce it in the U.S.? Also thinking on the tariffs and how is this product being produced. Thank you very much.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

The first question, I think that it will be taken by Nacho.

Nacho Abia (CEO)

Yeah. On the Canadian side, right, our presence in Canada goes back many years. I mean, that is not thanks to the agreement with Canadian Blood Services for self-sufficiency. Clearly, our partnership there positions us very well in a market which is very significant in the world.

We will be producing, I mean, number one, we are increasing the number of donor centers in agreement with Canadian Blood Services, and we plan to manufacture products in Canada. That will definitely improve our presence in the market and let us capture even a higher presence in that market. It's already happening as we speak, and it's more to come over the next years. As per fibrinogen, the plan is to start the production of fibrinogen in Germany in the Biotest facility, but later on to move that production to the United States to our Clayton facility. That's the current plan for that. Thank you, Jaime.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Thank you so much, Nacho. Now it's time for Graham Perry from Bank of America. Graham, please.

Charlie Hayward (Analyst)

Hi, this is Charlie Hayward from Bank of America. Quick question on Alpha-1, please.

Could you provide a ballpark number of your Alpha-1 revenues, and then how do you quantify the potential risk to that from an accelerated approval for INBRX 101? Secondly, on the contribution of Alpha-1 to your midterm guide, what do you reflect in terms of the potential competition from INBRX 101, and does your midterm outlook assume success of the Sparta and Subcut trials? Thank you.

Nacho Abia (CEO)

We do not disclose the Alpha-1 revenues. I mean, we share it together with specialty proteins as well, so we do not disclose that number. Regarding the potential impact of INBRX, this has been fully vacated in our long-range plans that were presented in the capital markets day, and this was in the best possible case for Sanofi that will be that the launch will happen in 2027 as it was previously announced.

This still has to be confirmed, but in any case, for our long-range plan, it is included, and we are considering a potential impact of that that obviously we will work to mitigate through our Sparta trial and other measures. As I say, this is the worst-case scenario for us, and this still needs to be confirmed. Anything that will delay that approval will be an upside on our long-range plan. Maybe Roland wants to add something to that?

Roland Wandeler (President)

The one thing to keep in mind for us is that Alpha-1 is an area where patients continue to be highly underdiagnosed and undertreated. About 15% of patients only are treated. What we do expect is with increasing awareness, with new options for patients, and also with increasing needs for screening, that the number of diagnosed and treated patients will increase.

What we have in our plan is, on one hand, a significant growth in treated patients and market that we see. Within this growth of the market, we have, of course, also from a risk adjustment perspective, assumed appropriate uptake for new entrants.

Charles Pitman (VP and Equity Research Analyst)

Thank you very much, Roland. Álvaro Lenze from Alantra, the floor is yours.

Álvaro Lenze (Sell-side Equity Analyst)

Hi, thanks for taking my questions. I just wanted some clarification on the U.S. dollar impact. I was quite surprised to see that you expect neutral to potentially even positive impact. I would understand that just the translation would have a negative impact, and it was also my understanding that you have less debt balance in U.S. dollar compared to the business exposure you have there.

I would have expected potentially a negative impact on leverage because your profits fall more than due to the translation than your debt falls due to the translation. If you could clarify that, would be very helpful. The second question would be looking at your $28 million IRA impact in Q1, and you mentioned the first invoice has been in line with expectations. Could we narrow down the expected IRA impact for 2025 to roughly $110 million, or are you still uncertain and prefer to stick to the $100 million-$150 million range you provided at the CMD? Thank you.

Rahul Srinivasan (CFO)

Thanks, Álvaro. On the U.S. dollar impact, the guidance that we've provided, I'll just repeat it, which is broadly neutral to positive from a group profit, leverage, and free cash flow standpoint, right?

Part of the reason for that is the embedded hedging that we have within our operations. You may look at our revenues and say, "Hey, we've got 70% or 60% of our revenues in U.S. dollars," but at the end of the day, you've got to also factor into that our COGS, our OpEx, inventory, U.S. dollar denomination. As you think through all of those various layers and the sensitivities that we've run, some pretty aggressive sensitivities, we feel pretty good about that guidance that I've just provided. I'll leave it at that.

With respect to your second question on the $28 million IRA accrual and the first invoice being in line with our expectations, as I mentioned, we believe that the midpoint, which is what we guided to during our capital markets day, if you remember the slide we talked about the $125 million impact, I believe that $125 million remains a prudent estimate based on what we've seen so far. Look, we've got one data point, and we will continue to update the market. Most importantly, we'll continue to be completely open with our numbers so that you guys can factor that impact in. I'll just repeat our confidence around the $125 million prudent estimate statement that I made in my prepared remarks. Thanks, Álvaro.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Thank you, Rahul. Thank you, Álvaro. The next question is coming from Guilherme from CaixaBank.

Guilherme Sampaio (Equity Research Analyst)

Hello. Thank you for taking my question.

Nacho Abia (CEO)

Just one still on the executive order, if possible. Could you at least reconfirm your exposure to Medicare and Medicaid post-IRA adjustments that you expect for this year? And then the second question, could you provide a bit more color on the significant step-up quarter-on-quarter in SG&A that we've seen this quarter? Thank you. Okay.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Roland is going to take the first question, and then the second question is going to go for Rahul. Roland, please.

Roland Wandeler (President)

Yeah, as Nacho said before, we don't provide specific breakouts of Medicaid or Medicare, but just for everybody to remember, a significant part of our use is in commercial patients. And as we look at Medicare, we actually have a mix of Part B and Part D, which puts us in a more device-first position.

As Nacho also emphasized, we will continue to educate that plasma-derived therapies are different from biopharmaceutical drugs, and we saw that this was recognized in the past. We see that looking across the world, price points are closer than what you see with general drugs. Lastly, we believe that we have a product portfolio that provides us with a differentiated offering across the world. Looking at all of that, we do at this point not expect any negative business impact from any executive order into 2025.

Rahul Srinivasan (CFO)

Your comment on SG&A, part of it relates to the reclassification in Q4 2024, if I followed your question correctly. Again, as part of revenue going up, SG&A as a percentage of sales obviously gets correspondingly impacted.

We have also got the fibrinogen launch as we think about working towards that just from an SG&A and OpEx standpoint as well. I will leave it at that, Guilherme, if I might.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Okay. Thank you so much, Rahul. Now we have a second round of questions. Charles, please. Charles Pittman from Barclays. Charles? Okay. It seems that Charles is not on the line. Jaime? Jaime Escribano from Banco Santander.

Jaime Escribano (Head of Iberian Small&Mid Caps)

Yeah. Hi. A couple of follow-up questions from my side. Maybe just to get some color on what is going on in IVIG and subcutaneous. Both are growing really well. Also, your peers, CSL, Takeda, also posting strong growth. At the same time, Argenx also growing very fast. I would like to hear what is your conclusion. Why does everybody seem to be growing so fast? If you can give us some hints on that.

Second question regarding the donor fee, if you can give us also some guidance on what is the pricing right now per donor, if it keeps going down, and is this also a driver for the gross margin? Finally, if I can say a final one, which is very quick because I think you will not answer, but I will try. If the Biotest bid is not successful and hence you do not spend this $300 million-$400 million bid, would you use these proceeds to, for example, buy Haema and BPC, or? Thank you.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Okay. The first question will be taken by Roland.

Roland Wandeler (President)

Yeah. Thank you, Jaime. I will take it actually on the IG side in two parts.

First, looking at subcutaneous IG, which in the U.S. is approved for primary immune deficiency, we are truly very encouraged with the momentum that we see, as Nacho and Rahul explained, in the 90s for Q1 and last 12 months, close to 70% like-for-like. This reflects uptake by prescribers in the U.S. from our focus that we have in the field, but also the profile of Xembify, which is very well appreciated by HCPs around the world, and our launch momentum ex-U.S. We still have significant opportunity ahead here, and as we continue to gain share in PID, and we expand our indication for Xembify in the U.S. with our CIDP and SID label. On the CIDP side, which is where your question comes in with Argenx, indeed, we continue to be very encouraged with the performance that we see for our IG there.

We see that the uptake for Argenx has mostly been in the second line. Recently, we also saw a number of patients actually switching back to IVIG after a trial of FcRNs. From what we hear from opinion leaders and what we see with our own brands, where our GammaNex continues to grow in this indication, we remain very confident in our first-line position for IG and the growth potential ahead. This reflects the fact that CIDP is a multifactorial disease. It reflects the fact that IG is ideally suited with its polyvalent mechanism of action to treat this disease. It reflects a long-standing experience and also, of course, the access hurdles, which are lower than perhaps for some other new entrants. From that perspective, we continue to be very encouraged.

The growth that you see, I think, reflects just the potential that you have in these diseases in general. CIDP as primary mental deficiency or secondary immune deficiency was underdiagnosed, undertreated. With increased awareness, we see that more patients get the benefit, and we are very glad that we can provide our medicine to these patients.

Nacho Abia (CEO)

Let me quickly comment on the donor fee, and then Rahul will comment on the Biotest question. We continue working on the donor fee mostly in two fronts. We have been seeing positive evolution, and we think that the positive evolution will continue. I mean, first of all, in the whole donor experience, right? We are working in matters from smart compensation and different activities to attract donors to our centers and to fidelize them in the centers.

At the same time, we're working on the rollout of the individual nomogram that is now present in 60% of our donor centers, and we are planning to continue the rollout through the year. I mean, these two initiatives in both fronts contribute nicely to the donors' fees in a way that it's a win-win for Grifols and for the donors, right? I think we strongly believe that this has to be in the benefit for both sides, and that's in the line that we are working for. On the Biotest, Rahul will comment.

Rahul Srinivasan (CFO)

Yeah. Look, on the Biotest, as I mentioned, BaFin have approved the delisting offer, and the offer period runs through till early June. I'm not going to speculate on take-up or not of the Biotest offer.

Relating to the extension of that question was if there wasn't, for whatever reason, take-up on that Biotest offer, would we apply that towards Haema BPC? We laid out a very clear capital allocation framework at our capital markets day that envisaged Haema BPC bringing that back within the group and making that acquisition or exercising that option during the course of probably Q2 of 2026 or thereabouts, maybe into 2027. That remains our plan. No change in that respect.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Okay. Thank you so much, Rahul. It seems that Charles Pittman from Barclays is back. Charles, please go ahead with your question.

Charles Pitman (VP and Equity Research Analyst)

Hi, guys. Sorry, can you hear me? Hopefully, you can. Just first question on pricing. Can you provide detail on the pricing differential of your products in U.S. and ex-U.S. regions?

Nacho Abia (CEO)

Secondly, on margins, what proportion of collected IG is being fractionated for Xembify, and what portion of IG do you expect that to account for over time? Effectively, what do you see as the future balance between SCIG and IVIG? Finally, a quick one. Can you give us any quantification of the phasing impact of the rabies on the other specialty, e.g., what was the underlying growth in Alpha-1? Thank you.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Yes. Roland, please.

Roland Wandeler (President)

Yeah. On the pricing differential, we will not disclose the details here. What we can say is that after the pandemic, we have seen prices actually come up in Europe and other parts of the world. Getting closer to the U.S., and as Nacho mentioned upfront, different from many other biopharmaceutical drugs, price points are actually much closer in plasma-derived therapies.

On the margin side, basically, the question goes at what's the share of sub-Q versus IVIG? Here, similarly, we don't disclose the details. I think what we can say is that we are closing in. In the past, I think we once made a statement that we were mid-single digits. I think we're closing in on high single digits at this moment with a lot of potential because from everything where we stand and the feedback that we receive, we don't see why our sub-Q share in the market would not be at the same level as our IVIG share is at the moment. As Rahul mentioned, we see that we're actually growing ahead of the market in both sub-Q and IVIG.

Lastly, on phasing impact on rabies, something to keep in mind is that due to the nature of rabies, where exposure happens in nature, this is much higher in summer, Q2, Q3, than Q4, Q1. Year over year, that's where small volume differences in purchasing in a Q1 can just translate into relatively high relative differences on a year-over-year basis.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Okay. Thank you so much, Roland. The next question is coming from Álvaro Lenze from Alantra. Álvaro, please.

Álvaro Lenze (Sell-side Equity Analyst)

Hi. Thanks for allowing me back into the queue. Two questions. I understand why the market is growing for IG, but just wanted to know if you could give us some more color on why are you outpacing the market. Is it better pricing than competitors, more product availability, or better clinical outcomes?

The second question is, if you're going faster than initially budgeted and you do not expect a negative impact from the dollar and are quite confident on the limited or no impact from tariffs and so on, why not raise the guidance for 2025? Is it that you're just being extra cautious or just to get a sense of your thinking process there? Thank you.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

Thank you, Álvaro. Roland will take the first question, and then Rahul will take on the guidance for the year.

Roland Wandeler (President)

Yeah. Álvaro, on the IG side, we believe that we're very well positioned to serve patients in this market, in this growing market, because there's more and more patients that finally do get access as these diseases are undiagnosed or undertreated. This comes from the brands that we have.

Grifols has, over the last decades, developed brands that are very well received in terms of the tolerability and the efficacy results by healthcare professionals, and we are building on these brands. It reflects the increased focus that we have been able to bring to the market over the last years, where we see that, especially in the U.S., the growth actually is driven by end-user uptake, which is very encouraging. With those two, both our portfolio that we have as well as the focus in the field, combined with our ability to supply, this puts us just in a good and strong position to benefit from the secular growth that you have in the IG side.

Rahul Srinivasan (CFO)

On your question on guidance, let me just repeat what I said on the dollar depreciating dollar.

A depreciating dollar is broadly neutral to positive from a group profit, leverage, and free cash flow standpoint. Yes, a structurally weaker dollar does pose a headwind in absolute revenues and EBITDA, even if it is positive from a margin standpoint. Back to your question around why, if we're ahead of plan, why are we not raising guidance? We are in Q1. We are in the middle of a macroeconomic or tariff diplomacy that is causing the world to spin in ways that we've not imagined. We have violent, sometimes, currency moves. At this point in time, Álvaro, I think it's prudence from our standpoint to maintain guidance, and we feel pretty good about that. I'll leave it at that for now, Álvaro.

Álvaro Lenze (Sell-side Equity Analyst)

Thank you so much, Rahul.

Dani Segarra (VP and Head of Investor Relations and Sustainability)

With that, we are ending the Q1 2025 call.

Just to say thank you very much for having us today. Thank you.