Grifols SA (GRFS) 2024 Q4 法說會逐字稿

Hello, everyone, and welcome to Grifols' full year 2024 financial results conference call. My name is Dani Sagara, and I'm the Head of Investor Relations and Sustainability. Today, I'm joined by Grifols' Chief Executive Officer, Nacho Abia; Chief Financial Officer, Rahul Srinivasan; and the President of Biopharma, Roland Wandeler.

Today's call will last about an hour, including a Q&A session. As a reminder, this call is being recorded. All materials used during the call are available on the Investor Relations website at grifols.com.

Moving to slide 2, I would first like to share a disclaimer on forward-looking statements. Forward-looking statements are subject to substantial risks and uncertainties. They are only valid on the day of the call and the company is under no obligation to update or revise them.

Default financial statements are prepared in accordance with EU IFRS and other applicable reporting provisions. This includes alternative performance measures, also known as APMs, prepared under the group financial reporting model as defined by the guidelines of the European Securities and Markets Authority.

Please note that Grifols' management uses APMs to evaluate its financial performance, cash flows and, financial position as the basis for its operational and strategic decisions. These APMs are prepared for all time periods presented in this document.

On today's call, Nacho will start with some introductory remarks, followed by a discussion on business performance and a strategic execution. Then Rahul will walk us through the financial resources for Q4 and full year 2024. 2025 guidance will be addressed in detail during tomorrow's Capital Market Day. After Rahul's remarks, we will hand it back to Nacho for his closing comments.

With that, thank you very much for joining us today. Nacho, over to you.

Thank you, Dani, and good evening, good afternoon, and good morning to all of you depending on where you are in the world. I appreciate you joining our full year results call.

It is my pleasure to share with you the completion of a year marked by meaningful accomplishments but also notable challenges for our company. 2024 has not been an easy year for us. We navigated a complex environment that challenged all of us to overcome several obstacles.

However, we remain focused on executing our strategy, upholding the mission and vision of the company and delivering on performance. For these reasons, I'm particularly proud on our teams and we're in focus and dedication throughout 2024. Their hard work and commitment enable us to achieve record results while continuing to drive our strategy forward.

Today, we will review these achievements, the key drivers and financial metrics behind our performance, and outline our priorities for achieving sustainable growth in the upcoming years. Tomorrow, February 27, the company will host its Capital Market Day in London where it will be a great opportunity to hear from Grifols' leaderships on the company's strategy ambition for the future, and also about our guidance for 2025.

Turning to slide 5, as already mentioned, 2024 presented many challenges. Despite this, the company continued implementing the strategy across the organization. This is reflected in our strong business performance, reinforced financial position, along with changes implemented at the governance level.

On the fundamental level of the business, we close a landmark year by outpacing market growth, driven by robust underlying demand and our strong Biopharma franchise. The solid business momentum was underpinned by increased plasma capabilities and efficiencies and the completion of all key 2024 innovation milestones.

We have reported improvements across key financial ratios while prioritizing free cash flow generation and the leveraging. Both Q4 and full year 2024, revenues and adjusted EBITDA reached new all-time highs. At the same time, we significantly strengthen our balance sheet through the Shanghai RAAS asset sale, organic leveraging, and enhanced liquidity.

We continue to reshape the company with the strengthening corporate governance and leadership team. The Board was expanded with additional members who brings a broad range of expertise and experience, reflecting an ongoing determination to the best practices.

As we announced yesterday, Thomas Glanzmann will retire from the Board, and then Catherine Berner will be nominated to become the new Chair after the AGM in June. Anne, joining as Independent Directors a few months ago, and I look forward to working with her to continue enhancing and strengthening our governance.

I want to take this opportunity to thank Thomas for his continued support and great contribution to Grifols over two decades, and specifically, for his strong support to me during the last year. Thanks for everything, Thomas. You will certainly be missed.

In parallel, the leadership team continued to evolve. Recent appointments of executive to key organizational position reflect a focused efforts to bring in top talent, blending fresh perspective with invaluable experience of internal leaders. This governance and leadership efforts has also been closely linked with our continuous improvements in sustainability, which is a fundamental aspect of our corporate and business activities.

In 2024, we advance our sustainability agenda, and this is reflected in Grifols being ranked the number one biotech company in the Dow Jones Best-in-Class Indices, and recognized as a 2025 Industry Top-Rated Company by Sustainalytics.

Shifting our focus to financial results in more detail. In Q4, we were able to continue building on the strong momentum and close the year on a high note. Revenues in the fourth quarter totaled nearly EUR2 billion, presenting a 13.6% increase, percentage increase on a constant currency basis compared to the previous year. These full record full year revenues, which reached the EUR72.2 billion, representing double-digit growth of 10.3% at cost and currency over a record 2023.

Adjusted EBITDA for the quarter reached EUR526 million with a margin of nearly 27%. Full year adjusted EBITDA came in just shy of full year guidance but exceeded market consensus reaching EUR1,779 million, an all-time record-high for the company with a 24.7% margin.

Regarding free cash flow, I want to emphasize the clear commitment and consistent execution we have demonstrated in this area. The sustained generation of cash flow has been a key milestone of our financial performance this year.

Thanks to our strong business fundamentals and conservative financial approach, free cash flow for the quarter further improved to EUR335 million and this contributed to a strong year end results of EUR267 million, far exceeding our initial guidance for the year. As we continue to view cash flow generation as a cornerstone of our strategy, Rahul will shortly provide a more in-depth analysis.

In parallel, we have continued to execute our disciplined approach to balance sheet strengthening and financial management. We have continued our organic leveraging path, reducing our leverage ratio to 4.6 times, a significant improvement over 6.8 times in Q1 '24, just three quarters ago. Additionally, we have conducted a series of capital market transactions that have helped us to refinance our debt, address near-term debt maturities, and enhance our liquidity position.

Turning to top line results, I will share the drivers to a positive performance. Reported, our total revenue grew by 10.3% at cost and currency in 2024. This growth has continued escalating from 9.3% in Q2, to 12.4% in Q3, and to a remarkable 13.6% in Q4, all on constant currency basis. This acceleration was steered by Biopharma, growing at 15.1% for the quarter, and 11.3% in the year.

Our Biopharma business, and more specifically, our immunoglobulin franchise, continued to be the cornerstone of our growth strategy with double-digit growth driven by IVIG and SCIG. Demand remains robust as immunoglobulin reinforces its position as the standard of care, which lead us to anticipate continued strong demand.

Albumin also delivered a solid performance as we continue to see demand across China and the US. The long-term agreement with China through Shanghai RAAS reinforces our position in this important albumin market.

Diagnostic, we saw a 2% decline on a constant currency basis for the quarter resulting in a 0.7% increase year-to-date. Diagnostic remains a key contributor to our business and even more important to our cash flow, as we maintain our leadership position and strengthen our presence in core markets. We remain confident in the future of Diagnostics as we are implementing our strategic plan.

Biopharma remains an attractive business with high growth potential. The rising demand for plasma drive therapies is clear given the amounts of undiagnosed patients within our core markets and clear potential for new indications on proteins.

Our Biopharma business continue to be the main growth driver in the fourth quarter. Robust underlying market demand coupled with improved commercial excellence, enable us to improve our sequential performance and growth compared to previous quarters, with a 15.1% increase in the fourth quarter and 11.3% year-to-date growth.

Immunoglobulin continues to be our highest growth protein, reflecting increasing demand for both intravenous and subcutaneous therapies. Cells of IVIG had a strong quarter, growing at 15.6% (sic - see slide 8, "14%")and closed the year with 13.6% growth, driven by a strong performance in the US and international markets.

At the same time, subcutaneous immunoglobulin sales demonstrated exceptional growth, expanding by 56% in the year at cost and currency, driven by successful launches and continued traction in key global regions. Meanwhile, albumin demand remains steady with full year growth of 8%, both at cost and currency, driven by consistent demand in China and the US.

Alpha-1 and specialty proteins continue with solid results improving for a year-to-date growth of 4.9% at constant currency. The US Alpha-1 franchise continues recovery momentum following the transition of the specialty pharma distributor, while demand for rabies continues solid to the quarter.

Our global diversified plasma footprint continues to enhance supply reliability, drive efficiencies, and support sustainable long-term growth. In the recent years, we have strategically expanded our donor center footprint globally.

Alongside, we have continued efforts to amplify network efficiency through implementing integrated new technologies and process improvements to optimize collection and manufacturing. Through targeted operational efficiencies, we have streamlined our organization and enhanced donor center operations, leading to consistent reduction in our cost per liter. Simultaneously, we have optimized donor compensation models to balance cost-efficiency, while maintaining lesser focus on donor experience.

As part of our efforts to continue the generating efficiency in our plasma optimization strategy, our core initiative is the individualized nomogram rollover, which is already implemented in approximately 60% of our US donor centers. This initiative is designed to improve donation quality and donor satisfaction, while increasing plasma volume per donation. With a strong execution plan in place, we're currently on track to fully improve nomogram US adoption, further enhancing our collection capabilities.

On the manufacturing side, we continue to deliver sustained yield improvement maximizing the output from each liter of plasma collected, which remains critical lever in ensuring a reliable and cost-effective supply.

Turn into slide 10. Innovation remains a fundamental pillar of our long-term strategy. And 2024 was a year of substantial progress in research and development. As I noted earlier, we achieved all innovation-related milestones, reinforcing our commitment to bringing transformative therapies to the market.

The most recent update within our pipeline is the progress of fibrinogen. After the success of the AdFirst clinical trial showing positive top line study results released in February 24, the required regulatory filings were completed in both Europe and in the US. The FDA has since accepted our BLA filing and granted a PDUFA date for December 27, 2025, respect the first countries' approvals in Europe and, thereafter, in the United States. In advance, we are on track to share the study results shortly as we have engaged with several relevant stakeholders in the scientific landscape.

We also released the completion of our PRECIOSA study. Although the trial did not meet this primary endpoint, an improvement in transplant free survival, mortality, and disease-related complications was observed for patients. Further, a notable improvement in time-to-liver transplant or death at three months was observed for the study treatment. We continue to work on analyzing the full results and we'll present them during the first half of the year.

Finally, as I speak through innovation as a fundamental pillar, I want to highlight that Grifols received a grant from The Michael J. Fox Foundation for Parkinson's research to identify plasma-based biomarkers that could indicate a person's likelihood of developing Parkinson's disease many years before clinical diagnosis.

The initiative, we call Chronos-PD, would accelerate the discovery of new diagnostic tools, as well as the identification and development of novel diseases modifying therapeutics. These advancements demonstrate the strength of our innovation pipeline and our dedication to improving patient outcomes.

And with that, I'll turn it over to Rahul who will walk us through our financial results. Thank you.

Thank you, Nacho. As slide eleven says, it has been a strong finish to a second consecutive record year, a performance that we are proud of, notwithstanding all the challenges faced by the company in 2024. Let me also take the opportunity to thank all our colleagues for their amazing work in 2024, keeping their eye and efforts resolutely focused on delivering for our customers and patients, while serving our donors. We often talk about the Grifols spirit internally. This collective performance in 2024 exemplifies this Grifols spirit, and I am proud to be a part of this awesome team.

Moving to page 12. Before I go into our Q4 and full year financial performance in 2024, please consider 2024's relative performance to what was already a record financial performance in 2023.

Q4 2024 was the best quarter in our history. In fact, our four best quarters ever have all come in the last five quarters, and our Q4 performance versus our prior record Q4 2023 performance shows the continuing strong momentum we have, significantly outgrowing revenues and adjusted EBITDA by 13.6% and 18.5%, respectively, on a constant currency basis.

The cherry on top of this performance was the significantly improved free cash flow generation pre-M&A of EUR335 million this quarter. And I will expand on the drivers of this performance further in the presentation.

With respect to our full year performance, very strong momentum and revenues up 10.3% on a constant currency basis to EUR7.2 billion, well ahead of guidance. Led by Biopharma that was up 11.3% on a constant currency basis over our prior record year in 2023, with our international business growing significantly and further diversifying our strong Biopharma business alongside our US business that also delivered a strong Q4. We are growing meaningfully faster than the market.

2024 adjusted EBITDA was up 21% on a constant currency basis. And adjusted EBITDA margin improving by 230 basis points, having improved 160 basis points in 2023. And also pleasing to see that momentum come through a net income that was up over 270%. Even if it is coming from a low base and fully acknowledging that that we have more work to do to fulfill our potential at that net income level.

Clearly, the standout performance was our significant beat at the free cash flow level, confirming our strong conviction around Grifols' ability to generate free cash flow. And we are confident around our ability to ramp up this free cash flow generation meaningfully over time.

On leverage at 4.6 times, it may seem that we fell shy of the 4.5 times expectation, but that does not reflect the full story. The rapid strengthening of the US dollar in Q4 created a headwind for us from a balance sheet translation perspective, which would ordinarily be more than offset by the positive impact at EBITDA level if the strengthening had happened, say, less rapidly over the course of the year.

Adjusting for this re-leveraging as a result of the rapid dollar strengthening, our leverage would have been in fact come inside the 4.5 times guidance. You can see our rapid deleveraging progress in the last four quarters from 6.8 times in Q1, to 4.6 times at the end of Q4.

The leverage indications here, consistent with the way we have shown it in the past, is defined as per our credit agreement. And as I had guided to in Q3, our secured leverage now is at only 2.7 times. That is the lowest I recall Grifols' secured leverage ever been. And finally, I feel very good about our liquidity position coming into 2025.

Slide 13. The consistency of the performance across the board and across every metric shows the fundamental health and momentum in the business. Quarterly revenue growth going up from 5.5% in Q1, all the way up to 13.6% in Q4. Quarterly EBITDA margin improving from 21.6% by 500 basis points to 26.6% in Q4.

Quarterly free cash flow pre-M&A progression, allowing us to convincingly beat our guidance. And on the leverage fund, other than the Shanghai RAAS disposal impact on metrics in Q2, the deleveraging has been organically driven by the significant growth in adjusted EBITDA and free cash flow pre-M&A performance.

Simply put, it has been a terrific year, led not only by actions from the business during the year, but also actions from the past bearing fruit. And we look forward to taking this momentum into 2025 and beyond, whilst dealing with the headwind of the Inflation Reduction Act in the US.

Slide 14. The simple message from this slide is that adjusted EBITDA is coming through in reported EBITDA rapidly, often within six to nine months. And I expect this convergence to continue, particularly as we focus on reducing the cash adjustments between adjusted EBITDA and reported EBITDA.

And the momentum in reported EBITDA is even more satisfying, having grown 32% versus our prior record year in 2023. Reported EBITDA margins grew 380 basis points in 2024, and the drivers for adjusted and reported EBITDA growth are CPL reduction, volume growth, yield improvement, and continuing operational leverage and cost discipline.

In terms of the main adjustments between adjusted and reported EBITDA, the main cash adjustment relate to one-off restructuring and transaction costs, so pretty identifiable and then being exceptional and one-off. And on non-cash adjustments, principally related to Biotest Next Level and impairments.

Slide 15. We see the clear evidence on the left-hand side of this slide of the operational leverage improvement I referred to on the prior slide, where OpEx as a percentage of sales has declined to 21% in 2024. As I mentioned on the Q3 call, we believe that there could be further squeezing of those OpEx margins possible, and we do intend to use some of that benefit to keep our R&D effort invigorated.

I would also like to update you on a change in our treatment of our US fee for services and GPO fees. In line with market practice, these fees will be accounted for in our gross to net sales rather than in OpEx, which will have no impact on EBITDA at all. The full year impact of this change was made in Q4 2024, and as a result, it will distort the revenue growth profile somewhat in the coming quarters.

Conversely, we have more work to do on the gross margin front, which is just as exciting as we think about our opportunities to continue our EBITDA margin growth in the coming years. And we believe that returning to pre-COVID gross margins is achievable, driven by further planned CPL reduction; commercial growth efforts across the board; new product launches, including fibrinogen and immunoglobulin; our yield improvement efforts; and continued execution of the plan at Biotest. More on this is part of our value creation plan at our Capital Markets Day presentation tomorrow.

Slide 16. This slide shows our quarterly evolution of free cash flow pre-M&A. We had a very strong finish to the year, generating EUR335 million of free cash flow pre-M&A, culminating a year with sequential improvement of free cash flow each quarter.

A couple of points to flag on this slide. One, the sequential improvement of free cash flow pre-M&A in 2024 is a coincidence, but it is fair to assume that Q1 tends to be our worst quarter, being meaningfully negative from a free cash flow generating perspective before turning in subsequent quarters.

The second topic I want to touch on was the key drivers behind our free cash flow outperformance in 2024, versus our prior guidance at the beginning of 2024. Two principal drivers for the outperformance.

One, unusually inventory evolution in 2024 released capital rather than consuming capital and this was due to: A, some of the structural improvements in inventory that I will touch on the next slide; and B, we have been much more aggressive in our management of inventory and again we will see that on the next slide. Second driver being a rationalizing and rescheduling of CapEx that isn't time critical, ending up spending meaningfully less than our guidance at the beginning of 2024.

Third point, I would caution against run rating Q4 cash flows are indeed the free cash flow conversion achieved in Q4. We finished 2024 with a free cash flow pre-M&A to adjusted EBITDA conversion of 15%, and we will share with you tomorrow our expectations to improve that during the course of our five-year strategic plan.

Fourthly, the benefit of having Diagnostics in our portfolio, given its high free cash flow conversion is very clear. And the final point I'd make here is that this business can absolutely produce meaningful amount of free cash flow, whilst continuing to support the capital needs of the business to be able to not only capture the highly attractive and secular top line and profitability growth opportunities, but also continue to develop a product portfolio to deal with any competitive threats over the medium- to long-term.

Based on all the actions taken in the past, both during the course of 2024 and earlier, it is clear that we have a number of levers to deliver progressively stronger free cash flow, and we will talk about that further in our Capital Markets Day tomorrow.

Slide 17. On the left-hand side, we show the evolution of our inventory days and the annual consumption or release in capital relating to inventory. The combination of lower inventory days and capital invested in inventory declining from 2022, and the exceptional capital released from inventory in 2024 are for the following reasons: CPL continuing to reduce nicely over the period; inventory levels improving, normalizing, implying less need to invest capital to replenish inventory levels; and improvement in balancing the [liter]; yield improvements essentially being able to do more with less.

In the case of 2024, a very strong sales push across the year and end-to-end supply chain management with respect to inventory. In our efforts to demonstrate more quickly our ability to unlock free cash regeneration pre-M&A, we have pushed this lever hard, and it shows us the art of the possible.

That being said, we will resume our investment in inventory from 2025 onwards, and balance being efficient with our inventory levels, while ensuring we have the right inventory to satisfy the strong and growing demand for our products. And you will hear from us tomorrow our plans for 2025 and beyond with a balanced approach.

On the right-hand side, this chart includes all our CapEx and capitalized IT and R&D over time, and the expectation remains that current elevated levels as a percentage of revenues will subside over the coming years. And tomorrow we will provide guidance on how to view our spend in absolute numbers, as well as the implied percentage of revenues that will show a meaningful normalization in the coming years.

We are in an industry that has secular high growth rates, one that benefits from high profitability levels with strong prospects for free cash flow generation pre-M&A. This is the lens through which we need to view our investment in inventory and CapEx and capitalized IT and R&D to capture these phenomenal opportunities.

Slide 18. Hopefully, the slide speaks for itself with respect to the underlying momentum behind the normalizing of free cash flow generation pre-M&A as we compare 2024 to 2023. This slide also shows the different phases of our inventory evolution since the pandemic, with 2023 being the last of the years where exceptional capital investment was required in order to replenish our inventory to more normalized levels.

And 2024 significantly benefiting from some of the factors I mentioned in the prior slide, including continued CPL reduction, strong sales growth in 2024, and a more aggressive end-to-end supply chain management with respect to our inventory. We continue to feel positive about improving free cash flow generation from EBITDA growth, subsiding levels of CapEx and capitalized IT and R&D over time, reducing cash outs from transaction and restructuring costs, and over time, reducing our cash interest. More on that when we present our strategic plan tomorrow.

Slide 19. Our balance sheet de-risking is substantially progressed and our continued focus on organic deleveraging will complete this process. The significant debt reduction achieved by the Shanghai RAAS state disposal; coupled with the strong deleveraging resulting from the 21% growth in our adjusted EBITDA; together with the meaningful outperformance of our free cash regeneration pre-M&A has taken leverage down from 6.8 times in Q1 to 4.6 times at the end of 2024, as we mentioned previously, with our secured leverage being, and what I think is, at an all-time low of 2.7 times. Add to that the leverage neutral refinancing we executed in December 2024, after which our next set of meaningful funded maturities is not until Q4 2027.

And finally, a significantly improved liquidity of EUR1.9 billion by the end of 2024. Our balance sheet is in a strong position, and I have no concerns at all about any refinancings as and when they come due, as evidenced by the two private placements this year.

Our key focus will be to optimize the conditions of the refinancing, and we can do that given our strong re-rating potential amongst using other levers. And finally, we have a syndicate of global banks that have supported our extension of the RCF and I'm very pleased with the high quality of the syndicate.

So to summarize, we have a strong finish to a second successive record year, and we have made significant progress on critical fronts; be it the meaningful outperformance on free cash flow generation pre-M&A or the substantial de-risking and strengthening of our balance sheet. We will stay resolutely focused on execution and driving the business forward. Notwithstanding the headwind of the Part D redesign in the Inflation Reduction Act, we look forward to updating you tomorrow on our strategic plan, as well as sharing our expectations for another record year in 2025.

With that, let me hand it back to Nacho to wrap it up.

Thank you, Rahul. I would like to wrap up the presentation with some final remarks. Reflecting upon 2024, we continue to position Grifols for long-term success. 2024 has been a pivotal year to ensure sustained growth and operational excellence.

Our commitment to discipline capital allocation, strategic expansion, and enhanced efficiency has created a stronger foundation for the future. We are proud of the achievements that have positioned the company for continued success.

We have shown resilience and delivered record-breaking financial results, strengthening our operational framework, and advancing our innovation pipeline, all while reinforcing our financial foundations. These accomplishments are a direct result of dedication, expertise, and perseverance of our global team.

Executing on our strategy and operational improvements have delivered continued savings and efficiencies. We maintain financial discipline and agility, and we are optimizing cash flow generation with a sharp focus on deleveraging to further strengthen our financial position. Additionally, our ongoing yield and manufacturing improvement and transformation programs are enhancing our operations, while continuing to drive down cost.

Looking ahead to the keys to our continued future success and growth, we must remain highly focused on executing upon our strategy. That's crystal clear. We hit all-time highs this past year, but that only sets the stage for us to expand this improvement into 2025.

We'll provide a clear road map tomorrow with a midterm strategic plan that will show how we will deliver sustainable growth and margin expansion over the next years. We will keep free cash flow generation and deleveraging as a top priority. And last, maintain the momentum gained through our commitment to best in class and sustainability.

I want to stress that we, as an organization, are not anywhere where we still want to be. We're just beginning on this path. As we move forward, we remain committed to better deliver long-term value for our shareholders, partners, donors, and the patients who rely on us.

Before we open the call for questions, I'd like to remind everyone that Grifols will be hosting its Capital Market Day tomorrow, February 27, at 1:30 PM, London time. We hope you will turn in to learn more about our plans for the future and our strategy for achieving long-term success.

Thank you again for your continued support. And with that, Dani, back to you.

(Conference Instructions) Thibault, Morgan Stanley.

First question just on the growth of immunoglobulin, it's been quite a strong growth acceleration for the year. Just if you could comment if the plasma collection capacity and the current level of inventory would allow you to continue that type of immunoglobulin, just high growth --

Just hold on a second, Thibault. Can you go through it again, please?

So my first question is just on immunoglobulin, very strong growth for this year. Just if you could comment on the current situation in terms of inventories and also plasma collection capacity, if you can sustain that growth going forward or if we should expect, in particular, more CapEx investment in order to support that growth? So, basically, the current state of your capacity to support that.

And then, just a question on the pipeline. So clear progress on fibrinogen. Just wanted to know if you could give us an update on trimodulin, the other protein, that was the center of the Biotest acquisition and when we can see an update here? Thank you.

Thank you, Thibault, for your question. I'll answer the first part and Roland will comment on the trimodulin.

As per the capacity of the company, I think that if you tune in tomorrow for the Capital Markets Day, we definitely share more information. But what I can tell you right now is that the company has been doing the homework in the last years and now we're well prepared, both from a donor center's capacity and also from manufacturing capacity for the future.

I think that the next year are in a very solid position, which means that essentially, the next wave of significant CapEx to expand our manufacturing footprint or the donor centers will not come in the next three to four years. Then is the time that we will need to entertain a significant CapEx again. But obviously, by then, our position will be different than today.

But for the next year, we are well-served. And tomorrow we will share more information about that. As for trimodulin, Roland will comment.

Yes, Nacho. Trimodulin, which is our polyclonal antibody preparation, including IgG, IgM and IgA, we continue with our Phase 3 study. We recently amended the protocol for updates in standard of care after COVID, which we believe positions us in a better place to have comparable data for the future.

The program is continuing. We are looking at an interim analysis that we're expecting in the first half of 2026. And needless to say, we remain very excited about the potential that trimodulin could bring for the treatment, not only for sCAP, which is the lead indication, but also for infections beyond that, and we'll be happy to explain that in more detail tomorrow.

Tom Jones, Berenberg.

So, my first question is just on revenue per liter trends. You mentioned in your prepared remarks that some of the benefits you saw in Q4 came from improved revenue per liter. I was just wondering if you could drill down a little bit more on that because it seems with IVIG significantly outpacing the growth of everything else, revenue per liter is probably going to be, if that carries on, you're going to get progressively more unbalanced revenues per liter, and you don't really make a lot of money just selling IG from a liter of plasma.

So beyond, perhaps the recovery in Alpha-1, is there anything else you can point to on new products where you will seek to try and improve the revenue per liter or at least stop or offset the disproportionate effect that the very rapid growth in IG has versus the other proteins.

So that was question one, and then question two, I was just wondering if you might be able to share what the impairment related to that you took in Q4. That'd be great. Thanks.

Yeah, Tom, starting with your question on revenue per liter. Important to highlight that we always aim to balance the growth in IG with the growth that we have on the albumin side. And looking at last year, we definitely were able to sell the equivalent amount of albumin, which obviously, helps just as the basis of the plasma economics in addition to the additional proteins that you mentioned. 2

And the other part to highlight is that we have seen, in course of last year, an improvement in yield for IG which further strengthens of course our revenue potential per liter, in addition with our work to gaining traction in the US and expanding globally. And perhaps the last point I want to make on the IG front is that we see very strong momentum with our subcutaneous IG in the US, that we have at the premium price, which also helps us on the pricing side.

So looking across, those are the drivers that translated into higher revenue per liter last year.

And the question on impairment, relatively small, I think it's roughly about EUR25 million or so, split between a small impairment at Grifols for something that is not publicly disclosed, but it's a tiny part of our healthcare services business. And then there's another portion within Biotest again. Relatively small numbers, Tom, so nothing I would -- but happy to pick it up in detail offline if you'd like to.

Alvaro, Alantra.

The first one is on gross margin. I see that on Q4, in particular, is down both in year-on-year and quarter-on-quarter terms. If you could explain what could have happened there. Of course, that has been offset by lower M&A cost because EBITDA margin is up, but just to understand the gross margin dynamics.

Second question, Rahul, I believe mentioned a significant impact from FXs on net debt because I believe from September to December, the dollar appreciated by 5%. So could you quantify the impact because when I try to reconciliate the net debt evolution compared to the $333 million (sic - see press release, "EUR335 million") free cash flow you provided in Q4, I estimate an impact of roughly EUR300 million, which to me would seem too much for the FX impact.

So if you could clarify that, it would be very helpful. And now, I will jump back for follow-up questions. Thank you.

Sure. So your question on gross margin, so if you go to page 31, you actually see an improvement of gross margin by roughly about 100 basis points versus 2023, driven by lower plasma costs. Most of that margin improvement actually coming from Biopharma, I think about 170 basis points or so. And drivers are low plasma costs; US CPL, down quite nicely; higher volume and revenues, which is always helpful; and then we had some negative effects going the other way.

One other thing that I would also say is that I made reference to the change in fee for services and GPO. That also has a negative impact on gross margin by roughly about 60 basis points to 80 basis points as well. So in reality, it could be higher than that. So that's the question on gross margin.

Your question related to the translation impact. As you know, we've got a reasonable portion of our debt that is denominated in US dollars, so a significant strengthening of the dollar creates a translation impact.

And if it's a rapid one, in this case, it actually creates a re-leveraging impact because ordinarily, a strengthening of the dollar is actually deleveraging because of the significantly improved impact of the EBITDA level. So in terms of quantifying, as I mentioned to you, if it wasn't for that strengthening, we would be between 4.4 times and 4.5 times, so just inside the 4.5 times guidance that we had provided previously. Thank you.

James Gordon, JPMorgan.

First one was just free cash generation, as you mentioned, it's a lot better this quarter, so strong in Q4. But in terms of phasing, so is working capital -- have you made quite a lot of the near-term progress already there? Or do you think that there's still quite a lot more to be done near-term?

And just connected with that, the extraordinary growth CapEx was only EUR20 million this quarter. So is that a helpful phasing benefit, but it just means you're going to have more still to come next year? Or actually, you're doing a bit less extraordinary growth CapEx. So how much extraordinary CapEx is there still out there and how much have you burnt through?

And the second question, there's some useful comments about gross margin, but one question I've had about for many companies is about what tariffs could do. So in terms of tariffs, if there is, it looks like a 25% tariff on product that comes in from Europe into the US.

Are you still doing quite a lot of fractionation in Barcelona and then that product's imported into the US? And how would that work? So if there is a 25% tariff on anything that comes from Barcelona in the US, how much of your US sales would that impact?

I'll take the tariff one and Rahul comment on the free cash flow and on extraordinary CapEx. On the tariff, obviously, the situation right now all over the world, I would say, I would call it fluid and moving. So I think we have to be prepared and we are.

So I think our company situation in this front is quite safe from the point of view that we have a large fractionation capacity in the United States and that we collect most of our plasma from the United States, too. So yes we still have some fractionation or significant fractionation in Barcelona, but definitely, if the tariff, which become in place, I mean, we might need to make some adjustment to the supply chain.

But we are in a position to do it because of our capacity in the United States both from a plasma generation and from a fractionation capacity. So we are good in that front. As per your second question or your first question, Rahul will come in now.

Thanks. Nacho. Your question about extraordinary growth CapEx. So if you go to page 18, James, what you'll see is that for the full year, we ended up with extraordinary growth CapEx of EUR276 million. And on our Q3 call, I believe I had guided to EUR280 million. So the phasing is entirely as we expected.

With respect to your question around inventory and free cash flow and more to go, as I mentioned earlier in my piece, there are a number of structural reasons why 2024 was very positive for us. And I touched on all of those, I think it was on slide 17 and 18. And I also reiterated our expectation that we will begin to invest in networking capital and inventory from 2025. And I will touch on that in more detail at our Capital Markets Day tomorrow.

Jaime, Santander.

Could you tell us how is the donor fee evolving and whether there is further downside potential there? And also, maybe, you can comment on how is the plasma collection growing? What is the strategy here to grow more in line with the sales or accumulate and collect more and have more inventories. And maybe a final one, if I may, competition from CIDP [argenx]. What are the dynamics you are seeing in the market? Thank you very much.

Thanks, Jaime. And I'll take the first, the comments on the plasma, and Roland will elaborate on the CIDP. I mean the donor's fees is a matter that has become quite complex and dynamic over time. I think that there is more and more smart compensations methodologies being applied, which represent a win-win for the donors and the company.

And I think that the evolution is not a linear evolution anymore, and I think that we could see situations where -- and that's our goal that we can offer a good proposition to the donors, while still being efficient in the utilization of our donor centers. And this answers, partially, your second question, right.

From a plasma collection point of view, our donor centers, as for the coming years as I mentioned before, we don't see an expansion in donor centers, because our stall base is sufficient. And we have significant capacity still in the existing donor centers.

So our focus is going to be to work with the donors, to incentivize well the donors, and increase the plasma collection in the existing centers. And we have that capacity and, definitely, it will come without any requirement for significant CapEx in this area at least in the next three years.

As for CIDP, Roland will comment.

Yes, for CIDP, we have seen some use of the FCRN blocker, mostly in second-line patients for the few patients that do not tolerate or do not respond to IVIG. But important to note that we have not seen any impact on the momentum on our side when it comes to CIDP.

And in fact, as you know, CIDP is a disease that still remains undiagnosed and where we see that increasing awareness is helping us to treat more patients. It is a disease that is multifactorial, which means that a range of mechanisms play a role. And it's a disease where IVIG, with its ability to actually attack all of these different mechanisms, remains and is the first line treatment. And this is what we hear back from thought leaders.

So to summarize, yes, some uptake. No impact on our momentum. And we remain very confident in the role as first line treatment of IVIG moving forward.

Guilherme, CaixaBank.

So the first question is on gross margin. You mentioned the 60 bps to 80 bps impact in terms of gross margin due to the difference in the counting. If you could clarify if this is for the full year, I assume so. And if you could provide the figures specifically for Q4, just to have a comparability with Q3 margin.

And then related to that also, if you have any ballpark figure on what level of cost per liter decline, since June 202 peak is already reflected in margins. This is on gross margins. Then if you could provide a bit more detail on the drivers of albumin growth slowdown this quarter, would be great. Thank you.

So on gross margin, the impact we're talking about is roughly EUR50 million. And essentially all that does is it reduces your net revenues by that amount, and it reduces OpEx. So no impact on EBITDA. And the impact on grass margin is somewhat indirect as a result as well, right? So that's how you get to those numbers. So hopefully that addresses the first point.

Your second question was on cost per liter. Look, I don't think we provide views on pricing of that cost per liter evolution. Suffice it to say that it continues to be a very healthy trend and we continue to feel pretty encouraged about where we can take that cost per liter and create the win-win situation that Nacho mentioned earlier on. And so still feel very encouraged about that.

On albumin, Roland.

And looking at albumin, our Q4, in terms of volume, was actually our highest score this year, so this is just a year-over-year comparison with a very strong Q4 that we had last year.

Charles Pitman, Barclays.

Just one quick clarification. Apologies if this is a simple question, but just on the reclassification of the change of treatment of fee for services. Can you just give us a little bit more detail around what drove this change? Like what does this mean for your recorded sales, COGS, and SG&A? And why, if this was an industry standard, was that not part of your prior reporting?

And then just secondly, within the IVIG, SCIG mix and how you've been performing over the course of this year. I was wondering if you can just give us a little bit more detail on what it is you're doing to continue to grow share?

And maybe if you could just touch a little bit more on the CIDP relative threat that you're seeing. I understand that's more second line, but given XEMBIFY is, I believe, not approved for CIDP, and this is a sub-cut maintenance in the second line. Is there an element here that actually Grifols' IVIG treatment is a little bit more shielded from this new competition of threat?

Love your thoughts on that. Thank you very much.

Sure. Let me take the first one, and Roland will finish the part of that first question before addressing the second one.

So it relates to fee for services and GPO fees. And one of the things that I was trying to do when I got in Q4 was essentially trying to do a detailed benchmarking and understand, essentially, where the upsides and downsides were across the business. And one of the things that came out of that exercise, and these are not big numbers, one of the things that came out of that exercise was that we were putting through OpEx, these fees, when a number of our competitors put it out as a reduction of sales.

It's not a positive change in some respects, but it's a more realistic change. Why do I say it's not positive? Because it actually impacts our growth rates quarter-on-quarter going forward. But what I wanted to try and do is understand, really, is there further upside on the OpEx as a percentage of sales, and this came out of that analysis. So relatively simple.

In terms of what it exactly is, Roland will touch on that in terms of fee for services and GPOs before addressing the second question, Roland.

Yeah, not much to add. It's just the general fee for services that you have in the US and the GPO group purchasing organization fees that in the past we classified as OpEx. They're just now going into the gross to net and, I think it's a standard, as you say Rahul, throughout the industry.

Going your questions around SCIG. Yes, we're absolutely excited with the momentum that we see. Very much so in the US and, you're right, our indication at this stage is in primary immune deficiency.

We see that our brand is highly valued there by prescribers. We see that our messaging is resonating very well. And we're investing, obviously, with our efforts on the commercial side to continue that momentum.

In parallel, in the US, we're advancing our study to get the CIDP indication for XEMBIFY, as well, which will position us for growth. In Europe, we are still in an early stage of launching XEMBIFY and we have a number of upcoming launches that will further expand our footprint there.

And then lastly on CIDP, yes, correct, in the US we don't promote XEMBIFY for CIDP. And from that side, yes, you could argue that the PID part, of course, would not be impacted. But I think beyond that, it's just important to highlight that we have a lot of confidence on the first-line role of IG treatments in general and CIDP with growth potential beyond.

Alvaro, Alantra.

Just if you could provide some detail on the IG dynamics, because, if I'm not mistaken, I saw on the CMS data that Medicare and Medicaid was paying a little bit of a lower price than it had in previous quarters. So I'm surprised of the acceleration in revenue.

So I don't know whether this is due to mix, due to the high growth on XEMBIFY. So maybe you could provide some of the dynamics in terms of volumes and price between the -- within IG. And then my second question would be on taxes, which were very high on Q4. I don't know if you explained that already on your prepared remarks. I'm sorry about that. I missed it. Thank you.

The main driver for our growth is coming from volume, no doubt. As you may recall in the US side at the end of last year, we said that we will be adjusting our price strategy to compete effectively. We've been doing that. And, indeed, when you look at the increasing share of SCIG and its premium price that is, of course, offsetting that trend.

And you know if you look at Europe, over the last years, we, together with the rest of the industry have been able to increase prices with the supply constraints that were there during the COVID time. And so, yes, we have over the last years, if you look at it, been able on the rest of roadside to bring prices up.

And relating to your question around taxes. So if I go to page 31 of the presentation, Alvaro, what you'll see is, as you rightly point out, your effective tax of 52% on a pre-tax income. And if you adjust for some of the one-offs, you get to a more normalized view around 26%. So as you rightly ask, what explains that difference?

Two principal things that I would call out. One is we've got an exception relating to the tax audit in Spain, and you'll see more details of that in note 28. I think it's page 95 in the English version of the accounts. And the simple thing there is we operate in four jurisdictions and, frankly, we should only pay tax in and not be duplicative.

And so this relates to a tax that'll take a number of years to work through that and that's the exceptional. And then the other aspect on the tax, elevated level of tax, it relates to the exceptionals related to taxes paid on the Shanghai RAAS consideration, which was disclosed earlier in the year as well. So those two things, frankly, explain the elevated levels.

But what I would really look at, and I'll talk about taxes a bit further tomorrow, in terms of the go forward tax rate, I think that 26% to 27% is the appropriate ballpark on a look forward basis. Thank you.

Thank you Raul. I mean, the second follow up just dropped, so that was the last question, the last answer. Just to say thank you so much for your support for being here and looking forward to see you tomorrow. Thank you so much.