Good afternoon, everyone. I want to welcome you to the Grifols 2025 Capital Markets Day. Thank you for joining us here in London, or virtually. It is much appreciated. My name is Dani Segarra, and I serve as the Head of Investor Relations and Sustainability and Vice President at Grifols. We're excited to share with you the ways in which Grifols has progressed over the past few years to achieve a record 2024 year and position the company itself for future value creation, all while maintaining our commitment with our patients and donors. The presentation will be posted to our website after the Spanish market closes and will be accessed from the Investor Relations section of our website. Before we get started, I would first like to share a disclaimer on forward-looking statements. During today's presentation, we will make statements that include information that is forward-looking.
These forward-looking statements are subject to risks and uncertainties involved in Grifols' business. As a result, the company performance may materially differ from those expressed or indicated by such statements, and the company is under no obligation to update or revise them. We have a full agenda today, beginning with a presentation from Grifols' Chief Executive Officer, Nacho Abia, who will walk you through our investment proposition and strategic vision for our next chapter of growth. Next, our Chief Financial Officer, Rahul Srinivasan, will provide a walkthrough of our financials, including a recap of our 2024 performance reported yesterday, before discussing 2024's guidance and our five-year vision on the back of a solid capital allocation framework that will allow us to unlock further value going forward.
After a brief 15-minute break, Roland Wandeler, our Biopharma President, joined by Nacho, will present our value creation plan specific to our opportunities, products, and pipeline. We will conclude today's presentation with a Q&A session, so please hold any questions until then. After Nacho's final remarks, we invite you, all those who are here physically, to join us at our reception. By the end of today's presentation, our goal is to provide you with a comprehensive overview of the company and its compelling investment proposition, then we will review our strategic priorities and value creation growth drivers and enablers, while providing the capital allocation framework that I was mentioning, supporting our 2029 vision and financial targets before moving to the Q&A session. Today's presenters, as mentioned, I'm joined by Nacho, our Chief Executive Officer; Rahul, our Chief Financial Officer; and Roland, President of Biopharma.
With that, I would like to hand it over to Nacho. Nacho?
Thank you, Dani.
Thank you, Dani. And good afternoon, everyone. I appreciate you joining us today. And for those of you in the room, it is great to put faces to the names I've been knowing for a while. It has been some time, and many things happened since the Grifols' last Capital Markets Day in June 2022. And we are excited to be here today to share the company's value creation story for the years to come. I am sure this marks one of many more opportunities to connect and engage with you over the course of the year. Yesterday, we shared our performance for 2024, which, despite being a complex year, was also a positive record year in many fronts.
Navigating such a challenging year while achieving our performance expectations speaks volumes about the resilience and persistence of this organization and gives me a strong confidence about what we can achieve in the years to come. Today, our main focus will be to share what drives our confidence in the business, how we plan to achieve our growth and profitability targets, and how we are positioning ourselves for successful execution of our strategic plan. This plan you are going to see today has been developed by me and the Grifols Senior Management Team, and it is backed up by solid and specific action plans to achieve every mentioned financial KPI. This is a bottom-up, forward-leaning plan that the entire organization is committed to deliver. Thanks in advance for your attention. We will start today's presentations with a brief overview of where we come from.
Grifols has a long-standing history of serving the needs of patients worldwide. Since its foundation more than 115 years ago, the company has been a pioneer and a leader in the plasma-derived therapies industry. Grifols has grown exponentially, both organically and inorganically, expanding in global reach by entering into strategic partnerships, exploring innovative technologies, and focusing on geographic expansion to support scale and meet the growing global demand. Over the last years, with a robust manufacturing network and an extensive plasma-centered footprint, we have consciously shifted our focus towards innovation, investing in R&D that enables us to strengthen our pipeline. We are dedicating significant efforts to progress on our life cycle management projects, pursuing new indications, as well as developing novel proteins. In the recent years, we have also prioritized fundamental enhancements, leading to a significant turnaround in our financial and operating performance.
This transformation has been driven by the successful implementation of our operational improvement plan, which brought more than EUR 450 million in savings through efficiencies while improving the cost and cash flow profile. At the same time, we completed the partial investment on Shanghai RAAS, maintaining a lesser focus on the leveraging and cash flow generation. Furthermore, we have strengthened our governance with a renewed board and leadership team, positioning us for continued success. As mentioned, Grifols has a proven track record of leveraging both organic and inorganic investments to drive growth and innovation throughout its history. Our evolution over the past two decades has solidified our position as a market leader, driving global expansion, diversifying our product offering, optimizing operations, and providing new solutions for existing and new patient needs.
Despite the challenges posed by the COVID-19 pandemic, we have consistently sought opportunities to stay at the forefront of the industry. Our strategy, which focuses on expanding our plasma supply network, broadening our portfolio, pursuing innovative technologies and partnerships, and exploring opportunities to expand geographically, has proven successful. As we present our strategic plan today, along with the growth drivers and enablers, the spirit of continuous innovation and improvements to drive further growth remains central. We are now committed to a balanced approach to growth that integrates a strategic perspective with a strict financial and capital allocation framework. This ensures that every step we take will generate substantial value for Grifols and all our stakeholders. Drilling down further, this slide highlights Grifols' impressive growth trajectory over the past two decades. Within the last ten years, we have doubled both revenue and EBITDA.
This growth demonstrates our unwavering focus on delivering sustainable and profitable growth, as evidenced by the EBITDA growth mirroring top-line revenue expansion. This success underscores the effectiveness of our approach to scaling the business, paving the way for continued sustainable and profitable growth. We expect to maintain this momentum through the execution of our strategic plan. As I will outline later, we are committed to sustaining our growth trajectory, focusing on our core priorities: generating free cash flow, delivering, and increasing profitability. While growing our business, we have established a strong foundation that positions us to confidently approach the future. Building on our market-leading position and a strong underlying performance, we have been strategically investing in our future growth. This includes reinforcing our pipeline with new assets, expanding our plasma supply, and making key investments to ensure continued market leadership.
These strategic initiatives, coupled with our solid business fundamentals, position us for sustainable success. One example of those strategic initiatives is the self-sufficiency projects that we are running in Canada and Egypt, and that the company has been developing over the last years, and that, once again, are helping to shape this industry for the benefits of the patients we serve. To effectively execute our strategic goals, we have undertaken a comprehensive organizational transformation. This includes strengthening governance for a new part of our leadership team, empowering key functional areas, and redesigning our organizational framework to enhance efficiency and agility. Additionally, we restructured the company to better align capabilities with functional areas, including reducing management layers to streamline business units and improve accountability. Finally, we have streamlined our operations, enhanced efficiencies, and strengthened the resilience of the business.
We have fostered a culture of continuous innovation and are now prioritizing innovation, cash generation, and organic leveraging. These goals are integral to our company culture, as we have strived for sustainable growth underpinned by some financial principles. Turning to slide 12, although we discussed this during our earnings call yesterday, I would like to reiterate the record results achieved in 2024. Despite many challenges throughout the year, we demonstrated focus and commitment, delivering strong results across the board. In 2024, we outperformed market growth driven by robust demand for our biopharma franchise and continued operational excellence. This resulted in our all-time highest revenues and EBITDA, while also exceeding expectations in free cash flow generation and significantly delivering in the balance sheet. These strong financial results were supported by the continued reinforcement of our R&D capabilities as we achieved all our innovation milestones for 2024.
On the corporate governance front, we continue to strengthen and diversify our board by adding four new directors this year, which two of them are independent. These new board members help broaden the collective experience and international backgrounds of the board. Together, they bring strong credentials and backgrounds in healthcare, plasma, life sciences, technology and innovation, and finance and accounting. As mentioned yesterday, Thomas Glanzmann will retire from the board, and Anne-Catherine Berner will be nominated to become the new chair after the AGM in June. Anne joined a few months ago as independent director, and I look forward to working with her to continue enhancing and strengthening our governance. This, together with other board changes over the last years, reflects Grifols' commitment to corporate governance excellence, ultimately supporting the creation of value for all our shareholders.
Another accomplishment of 2024, which I'm particularly happy about, is the executive management we have put together over the last months. We have built a management team with a deep bench of experienced leaders, some of whom are company veterans and others who bring valuable outside expertise. This blend of deep understanding of Grifols' business, along with fresh perspectives, provides the right balance of expertise to leverage existing growth drivers while capitalizing on new initiatives. This management team, who is with us today, will be instrumental in driving performance by making company-wide decisions and ensuring alignment and execution alongside the Standard Executive Committee. Together, I am sure we will lead effectively and accountably over the upcoming years. Now that we have reviewed the foundation that will underpin our future success, let's take a closer look at the value proposition.
Today's Grifols is uniquely poised to tap further value for shareholders through our global reach, strong fundamentals, and the execution of our strategies to maximize the potential of our resilient industry. I want to highlight four competitive advantages. One, at the heart of Grifols' opportunity is an attractive market with high single-digit growth potential. Roland will soon dive deeper into our product portfolio and pipeline and how we are positioning ourselves to capitalize on this strong market. Two, Grifols benefits from its 115+ years' legacy, global scale, and industry-leading capabilities. Three, key enabler of our success is our full vertical integration, which spans the entire supply chain from donor to patient, from vein to vein, and four, as previously mentioned, our strategic investments have resulted in significant industrial and plasma capacity, positioning us to effectively meet growing demand.
Now I want to share why we feel so confident in the potential our industry offers. The opportunities presented by the plasma industry are compelling. Public estimates place the total current global plasma market at approximately EUR 3 billion, an industry that is growing by high single digits, supported by strong underlying market dynamics. First and foremost, plasma-derived therapies are a well-established standard of care, providing a safe and effective treatment modality. Also, the underdiagnosis of existing diseases, the critical need for plasma-based therapies in underserved markets, and innovation-driven discoveries for new potential protein therapeutics are key drivers for the industry. Furthermore, substantial potential remains in exploring new indications and proteins. It is also important to note that we operate in a capital-intensive industry where scaling the production of complex plasma products is not a small feat.
This, together with the significant time investment required to develop products and the regulatory hurdles, makes clear that Grifols has built a competitive moat as a current leader in the field. As one of the top three leading players in the plasma industry, our brands are strong and highly recognized globally. In an industry built around people's health, the stability of our products is critical, and this takes time and consistent excellence to build trust. Within the industry, Grifols has the largest global footprint and a well-diversified plasma network, which supports our ability to manage increasing capacity as global demand increases. Our scale also enables us to bring new products and indications to market seamlessly and efficiently. In addition, we are deeply committed to innovation, with a robust pipeline under development across four key therapeutics areas, as we continue to work towards bringing new products and indications to market.
Another competitive advantage is our fully vertically integrated business model. From donor to patient, we control every step of the process: plasma collection through our extensive network of donor centers, manufacturing and testing through our global facilities, and commercialization and distribution of our products. This comprehensive oversight across the entire supply chain is critical, with visibility across the value chain. We can respond faster to changing market dynamics, better managing any necessary changes to collection efforts as well as inventory, while maintaining the highest level of quality and cost control. Looking at our global operations, we can see that Grifols' network of plasma donor centers and manufacturing facilities is well-diversified. In addition to a large presence in our most important market, the United States, we also have the largest presence outside the U.S. and the most diverse plasma network.
With more than one quarter of our donor centers located outside the U.S., we ensure access to a growing and diverse plasma supply, providing the flexibility to meet evolving industry demand. Likewise, our manufacturing facilities are also located in strategic areas that allow us to support the development of sustainable plasma-derived therapies and to strengthen our regional presence. This consolidated, diverse footprint provides three main advantages. First, it ensures a reliable and expanding source of plasma. Second, it helps mitigate potential supply and manufacturing disruptions. And third, it enhances our ability to expand and serve global demand. Having covered the strong fundamentals Grifols has in place and how they contribute to our compelling value proposition, I'll now turn to our five-year strategic plan and vision for the next decade. Turning to slide 22, I'd like to present our value creation framework.
This framework lays out the core fundamentals for our path forward, highlighting the clear vision and mission that guide our overall direction. Our vision and mission are grounded in Grifols' principal values and behaviors, which define our culture and guide how we operate, steering the ambitions for each of our business units. For our biopharma business, the goal is to become the industry leader in plasma and beyond with a best-in-class portfolio while excelling in productivity, efficiency, and optimization. For our diagnostics business, the focus is to provide innovative technologies and solutions that improve the lives of both blood and plasma donors and patients. We will achieve these ambitions through four key enablers. First, our robust donor centers and manufacturing facilities. Second, our investment in innovation, which will bring new products and indications to market. Third, our diverse talent, which enhances productivity and effectiveness.
And fourth, our investment in IT and digital capabilities. All in all, our path forward for its business is built upon our core principles: an unwavering commitment to sustainability, recognized through our award-winning efforts, along with financial and capital allocation discipline. As our company has evolved through its history, our commitment to our vision and mission has kept us grounded and focused on what matters most: providing life-enhancing therapies and solutions to our patients. As we enter this next chapter at Grifols, we remain true to our ethos and patient-first approach. Our mission is to deliver innovative and differentiated biopharma therapeutics and unique diagnostic solutions globally and sustainably. With insights and endorsement of the board, we have developed a well-thought-out and detailed value creation plan for the next five years that will serve as the foundation for our 10-year vision.
We have complemented our five-year targets with aspirations for 2034 to illustrate that while we are confident in delivering our promises over the next 10 years, we also keep committed and confident in a sustainable, long-term, profitable growth for Grifols. These aspirations are grounded in our innovation strategy, financial rigor, and capital expenditure planning, all driven by a shared set of core principles. These principles will guide our decisions across all areas, ensuring alignment between our investments in future growth and our commitments to developing cutting-edge solutions. Today's presentations and our plans for value creation are the culmination of the transformative organization changes we have implemented over the last years. Let's put now some numbers behind our five-year plan and 10-year aspiration. Rahul will dive deeper into this shortly to provide further background.
Based upon our historical growth over the past 20 years, including our record growth in 2023 and 2024, we feel comfortable in our ability to achieve EUR 10 billion revenue by 2029 and EUR 14 billion in revenue by 2034, doubling our size over the next decade. This growth will be driven by positive market dynamics, demand for our products, innovation in therapeutic solutions, and cost management. Providing revenue figures 10 years out is indicative of the confidence we have in the actions we are taking to position us to remain flexible and seize opportunities to remain an industry leader for years to come. Substantial revenue growth will be further supported by continuous improvement in profitability as we maintain our focus on financial discipline, operational effectiveness, and cost optimization.
As such, we project significant EBITDA growth over the next five years, confident in our ability to reach approximately EUR 2.9 billion with a margin between 29%–30%. Indeed, these improvements in top-line revenue and profitability will be paired by a strong cash flow generation, and our entire strategic plan is focused on consistently delivering in this area. Therefore, we project incremental improvement in free cash flow generation, targeting approximately EUR 1.2 billion in free cash flow by 2029, with a cash conversion rate over EBITDA of 40%. This continuous improvement is a core financial pillar of our strategy. Let me take you a level deeper on how we are going to deliver on these goals. First, we are going to take a more disciplined approach to capital allocation.
We have invested in the past years to position the business for success, and these efforts have positioned us to where we are today, ready to fully realize the potential of our existing assets to drive growth. This approach focuses on organic investment without requiring significant additional commitments. Our biopharma business will be the cornerstone of our growth. As I'll discuss in a moment, we see significant opportunities to maximize value through the operational improvements we have implemented across our network and new proteins launched on the horizon. While the Part B redesign of the Inflation Reduction Act will have some impacts, we remain confident in our robust growth that will continue throughout the coming years. Rahul will provide further details on these metrics with our focus fully on organic growth. We will also implement measures to control our expenses and continuously expand our margins.
As we scale the business for growth, we will maintain discipline in managing our SG&A costs, keeping them lean and manageable. Our financial efforts will be targeted towards the strategic R&D efforts that support our innovation strategy, alongside advancement in our analytical, digital, and technological approach to operation. Rahul will explain shortly; these combined efforts are expected to help us reach our 2029 goal of a 40% conversion rate of EBITDA to free cash flow generated. Turning to the next slide, I will share why we believe our value creation plan will drive revenue acceleration and margin improvements. As mentioned, our strong revenue growth will continue to be driven by Biopharma, which estimates a 7% CAGR over the next five years. With IG continuing to be the principal component, we will see high single-digit expansion.
The launch of Fibrinogen will significantly contribute, where our Alpha-1 and specialty products will remain well-positioned as trusted global providers. We plan to leverage on the operational improvements within our plasma network to maximize plasma utilization, improve manufacturing efficiencies, and enhance plasma yields. Our diagnostics business will continue to grow, contributing positively with a projected CAGR of approximately 5% while maintaining high EBITDA and cash conversion ratios. Before I conclude this section, let's take a look at our value creation levers. Revenue growth through existing and new products and indications, together with our efforts to optimize the cost per liter and improve our yields, will generate the positive dynamic in our plasma economics that will help continuously expand our EBITDA and cash flow position.
Roland will explain in more detail later, this chart, sharing with you the specific action plans for each of these levers that will be basis to achieve our financial goals. In this chart, the white space represents the opportunity to significantly increase revenue per liter and improve margins with both fibrinogen and Trimodulin and our life cycle management launches. We expect these new products and additional upcoming ones to fill this white space. Also, continued improvements in cash generation, working capital management, and capital allocation will play a key role, which Rahul will cover in more detail. To recap what we've discussed, our 2024 results and today's presentation reflect the strengthening of our board management team and organizational structure. We have instilled a new way of thinking at Grifols, which has led to a more disciplined approach to business fundamentals while enhancing our financial profile and capital structure.
We are now ready to take the next step, leveraging our strong foundation and asset footprint to achieve EUR 10 billion revenue by 2029 while improving profitability to reach a 29%–30% EBITDA margin. Building on these mid-term goals, we aim to double revenue by 2034, reaching approximately EUR 14 billion. Our confidence in achieving the milestone is driven by our value creation plan, which in turn is grounded in the continued focus on free cash flow growth and balance sheet leveraging to support a steady organic growth aligned with market trends. Thanks for your attention so far, and I'll now turn the presentation over to Rahul, who will share some of the key financial metrics that will help to unlock significant value. Rahul?
Thanks, Nacho.
The title page of this next section is a clear giveaway of our key focus, which is to prioritize free cash flow generation and to drive significant free cash flow growth during the course of our strategic plan. And our expectation is that this free cash flow generation focus and its delivery, taken together with all the other attributes that have made Grifols a leading player in a highly attractive market, should unlock a substantial re-rating of our story over time. I will cover four principal topics: a quick summary of our 2024 results call from yesterday to contextualize our go-forward story, present our guidance for 2025, walk you through our strategic plan and the considerable capacity that it implies for capital allocation optionality, and round out the section with our capital allocation framework. 2024 was our second consecutive record year.
Notwithstanding all the challenges faced by the company in 2024, to produce as the company has is a testament to the Grifols spirit within the team, a team that I am proud to be a part of. As discussed in our results call yesterday, we delivered very strong momentum in revenues, up 10.3% on a constant currency basis to EUR 7.2 billion, well ahead of guidance. Led by a biopharma business 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 in the U.S. that also delivered strong growth in Q4. On the chart below, we see the strong momentum in EBITDA, adjusted EBITDA up 21% and reported EBITDA up 32% on our prior record year in 2023.
EBITDA and margin growth has been driven by CPL reduction, strong volume growth, yield improvement, and the benefits of operating leverage and cost discipline. Adjusted EBITDA margins increased by 230 basis points in 2024 and 160 basis points in 2023. Reported EBITDA margin improvement was even better, 380 basis points in 2024, and as a result, we continue to see a greater convergence between reported and adjusted EBITDA with declining cash adjustments, and our expectation is for that to continue. Thus far, it has taken Grifols nine months or less, on average, to convert its adjusted EBITDA to reported EBITDA, reflecting the extraordinary or one-off nature of a number of these cash adjustments. Our significant free cash flow outperformance versus 2023 and guidance beat is an inflection point, we believe, in our free cash flow generation story.
Bottom line is that this business can absolutely produce a meaningful amount of cash while 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 our 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 even earlier, it is clear to me that we have the levers to deliver progressively strong free cash flow generation. 2024 free cash flow outperformance versus 2023 was driven by the significantly higher EBITDA in 2024 versus 2023 and a more aggressive approach to managing inventory, notwithstanding the significantly greater growth CapEx that was previously disclosed.
Finally, on leverage and liquidity, as I mentioned yesterday, we feel in a very good place, having delevered from 6.8 times in Q1 2024 to 4.6 times in Q4 2024, and we will continue to organically delever. Again, as I touched on yesterday's Q4 call, the critical Shanghai RAAS disposal and the associated debt reduction followed by the leverage-neutral transaction in Q4 alongside the RCF extension has delivered a significant de-risking of our balance sheet. Leverage is under control. Of course, we will continue on our deleveraging path organically. We have no meaningful funded maturities till Q4 2027, and liquidity is in a very good place. We have demonstrable access to the capital markets, as evidenced by the two private placement transactions that we did very quickly. Secured leverage at only 2.7 times is as low as I recall it ever being.
We expect to continue our re-rating trend by continuing to deliver performance-wise. For 2025, our commitment remains the same: driving sustainable growth, strengthening our financial position, and delivering value to our shareholders, with a clear expectation of maintaining in 2025 our record run from a financial performance perspective. Our core business remains strong, and the strategic initiatives we put in place over time will ensure we keep growing efficiently and profitably. We summarize on this slide our main financial expectations for 2025, the key drivers behind our growth, and how we are managing the impact Part D redesign in the Inflation Reduction Act (IRA) while maintaining our focus on long-term success. For 2025, we expect revenues to reach approximately EUR 7.7 billion, excluding the impact of IRA.
This represents a solid 7% increase over the prior record year and is driven largely by the strong performance of our biopharma segment, particularly the continued growth of our IG franchise. Moving on to profitability, excluding the impact of IRA, we are targeting EUR 2.025 billion, it's a coincidence, 2025 and 2025 in adjusted EBITDA, which translates to an adjusted EBITDA margin of approximately 26.3%, an improvement of 160 basis points pre the impact of IRA. This is a notable improvement, as I mentioned, versus 2024, reflecting the operational efficiencies we've implemented across the organization. We are focused on not only growing our top-line and profitability performance but also delivering a step change in our free cash flow generation pre-M&A. For 2025, excluding the impact of IRA, we expect to generate around EUR 500 million in free cash flow pre-M&A, which is a significant improvement from EUR 266 million in 2024.
This puts our implied free cash flow conversion rate at approximately 25%, reinforcing our ability to efficiently translate EBITDA into cash, excluding the impact of IRA. What's driving our growth? There are several key factors fueling our strong performance. Biopharma leading the way. Our IG portfolio remains a key driver with robust demand across all regions. Within IG, sub-Q IG continues to gain traction with very strong growth, reinforcing our position as a leader in IG overall. Operational efficiencies that drive profitability. We are optimizing plasma costs by streamlining our donor center operations and improving overall efficiency. We are enhancing plasma yield, both at the collection and manufacturing levels, which directly improves margins. Disciplined cost management. We are maintaining a rigorous approach to OPEX control, ensuring that we continue to grow profitably without unnecessary cost expansion.
Number four, and remain highly disciplined and cash conscious, boosting our free cash flow expectations for 2025 versus 2024, notwithstanding the IRA impact that I mentioned earlier. So let's give you a bit more information around the IRA impact. Given the Part D redesign under the Inflation Reduction Act this year, we want to clearly outline the provisions that could potentially impact our U.S. business and thus affecting our approach to 2025 guidance. As a recap, these are essentially three components which impact the broader healthcare industry: price negotiations, inflation price ceiling, Part D redesign. The first two have no impact on our business. Plasma-derived therapies are exempt from Medicare's price negotiation provision, and the inflation price ceiling has already been factored into our figures, currently posing no material risk.
The component of the IRA most relevant to Grifols is Part D redesign, which we are considering and quantifying in our Part D redesign, on the one hand, lowers the copay for patients, which will aid access, but it also shifts part of the cost from Medicare to manufacturers and payers during the catastrophic coverage phase. The two main products impacted are IG and Alpha-1 therapies. Note that these medicines can be covered both under Part B and Part D in the U.S. Thus, the financial impact will depend on the actual number of patients treated under Part D versus Part B, but our current estimates suggest a potential impact in the range of EUR 100–EUR 150 million gross to net in 2025, equally impacting sales, EBITDA, and free cash flow pre-M&A.
We refer Part D redesign impact simply as excluding or including IRA in the rest of the presentation. Revised 2025 guidance, including the impact of IRA. Taking the IRA impact into account, our updated guidance for 2025 is revenues in the range of EUR 7.55–EUR 7.6 billion, adjusted EBITDA between EUR 1.875–EUR 1.925 billion, free cash flow pre-M&A between EUR 350–EUR 400 million, with an implied free cash flow pre-M&A conversion rate of 20% and a considerable growth versus the EUR 266 million in 2024. With this guidance, our growth story remains intact. We remain highly confident about our outlook. As I mentioned yesterday, growth and free cash flow phasing will continue like prior years, with Q1 tending to be our weakest quarter with a negative free cash flow and lower growth in Q1 and then turning thereafter across the rest of the year.
Final thoughts on this: to sum up, we expect to deliver another record year in 2025. We are executing our strategy with discipline, strengthening our competitive position, and investing in the future while maintaining a sharp focus on efficiency, profitability, and free cash flow generation. On page 39, we illustrate a free cash flow pre-M&A bridge between 2024 and 2025, including the impact of IRA, and we summarize the key drivers and their directional impact on free cash flow pre-M&A in 2025, so relative to the 2024 free cash flow pre-M&A performance, we expect positive free cash flow impact from increased EBITDA, lower CapEx, which also includes exceptional growth CapEx and capitalized R&D and IT, and lower restructuring and transaction costs.
We expect interest to be flat versus 2024, and in contrast, we expect a negative impact from our need to invest in inventory and working capital, increased taxes as a result of improving profitability, and a relatively small increase in the others line within our free cash flow statement, which we would have expected to have resulted in a free cash flow pre-M&A excluding IRA of circa EUR 500 million or a 25% free cash flow conversion. But given the impact of IRA of EUR 100–EUR 150 million, this implies a post-IRA free cash flow pre-M&A performance of EUR 350–EUR 400 million or 20% free cash flow conversion, a significant improvement versus the 2025 free cash flow pre-M&A and the 15% associated conversion rate thereof, despite the negative impact of IRA in 2025. Slide 40, our strategic plan. Just a few words on how we have approached the strategic plan.
This is a detailed bottom-up model to support the strategic plan, and it reflects all the information we have currently, including our expectation for the evolution of the Inflation Part D redesign in the coming years, current FX rates, and our expectations for each of the markets that we operate in, including our assessment of the competitive dynamics. The other point to make is that our strategic plan is largely an organic one, harvesting opportunities that exist within our portfolio. In the capital allocation section, you will see a couple of potential inorganic actions within our existing portfolio that we intend to consider at the right time and under the right conditions. With that background, let's take a closer look at our strategic plan. This is the punchline.
In the five-year period from 2025 through 2029, we expect cumulative free cash flow generation pre-M&A of approximately EUR 3.5–EUR 3.75 billion. With our free cash flow pre-M&A conversion ratio of adjusted EBITDA margin growing from 15% in 2024 to 40% by the end of 2029. In addition, we have provided an update on prior free cash flow pre-M&A guidance that had been provided in early 2024, with our revised expectation for cumulative free cash flow pre-M&A from 2024 to 2027 to be in the range of EUR 1.75–EUR 2 billion versus the prior range of 2024 to 2027 of EUR 2–EUR 2.5 billion. I think the principal difference between our updated views today and the prior view provided in early 2024 is really the impact of IRA, which, as you're aware, commenced or implementation began on the 1st of January 2025. Slide 42.
This slide's inclusion caused a bit of a debate on our side, but let me explain to you what we are trying to communicate with this slide. Very simply, our strategic plan pre-M&A pre-dividends implies the theoretical and illustrative deleveraging profile that is summarized on this slide. We are not saying that we expect our leverage to decline to the one and a half to one and three quarters by 2029 that this slide suggests. You will see in the capital allocation policy section that we guide to a target net leverage in the three to three and a half times range, thereby going back to being a strong Double B credit that we were prior to the significant impact of this once-in-a-hundred-year pandemic. But the purpose of this slide is that this strategic plan pre-M&A and pre-dividend suggests significant deleveraging capacity and such capacity creating significant capital allocation optionality.
Over the planned period, we expect to deliver strong growth, roughly 7% CAGR from 2024 to 2029, led by biopharma, but with diagnostics also contributing exciting growth in the latter stages of the planned period. The strategic plan is a bottom-up plan anchored by realistic assumptions that the whole organization is committed to delivering. While our growth rates recently beat revenue or EBITDA, growths have been meaningfully higher than those that you see in the strategic plan. The significant potential embedded in our story is backed by realistic assumptions. Let me walk you through the approach across various parts of our business. Let me start with biopharma. Within biopharma in IG, we're planning to grow on the high side of the market with our main franchise IG.
On IG growth, it's important to know that while the US market shows consistent volume growth at high single digits, the rest of the world is expected to see even more robust expansion. We are focused on margin expansion by improving our product mix, particularly Xembify, where we anticipate continuing to grow aggressively. Albumin. Albumin sales are expected to grow low single digit, balancing the leader given our expected yield improvements in IG, driven by increased volumes and accounting for any pricing pressures. We expect balanced growth across China and US, with higher growth across other regions. In Alpha-1, again, a realistic plan that reflects our clear leadership position in this space, together with the opportunities of untapped market demand and the sub-Q formulation as well as being cognizant of potential impact of competition in due course. New proteins from Biotest.
We remain optimistic about the potential of the new protein, starting with the Yimmugo and in a few quarters' time, Fibrinogen, and excited about the potential of Trimodulin in due course, with gross margins expected to align with our overall biopharma expectation over time. Diagnostics. On prior calls and again today, Nacho articulates our vision for the diagnostics business, building on our leadership in blood typing solutions and molecular donor screening to solidify our leadership in transfusion medicine while expanding into the broader clinical diagnostics market, where we are excited about the growth opportunities, leveraging our existing competencies, and we look forward to our new product launches, Barcelona, Isard, and Mundaka during the period of our strategic plan, driving circa 5% revenue CAGR during the planned period, with the diagnostics business seeing its growth inflection point in 2026–2027.
Our plan is to grow our EBITDA margin by circa 500 basis points by 2029 from 2024. This equates to a CAGR of 10% over this period, with strong growth from both biopharma and diagnostics, and let me elaborate further on the profitability side. Within COGS and operational efficiency, as I mentioned yesterday, we have a significant opportunity to improve our EBITDA margins in line with our pre-COVID margins during the planned period by executing on our clear plan to boost gross margin driven by the following factors. Number one, plasma procurement. We are confident about continuing to reduce CPL over time as well as drive further improvements from a plasma sourcing perspective. Number two, yield improvement program, strong expectations for continued progress on this front over time.
As far as OpEx goes, as we discussed on our Q4 call yesterday, our OpEx spend at 21% of sales is quite efficient already. For the strategic plan, we're expecting higher spend on R&D and IT to support our innovation pipeline and our digitization initiatives. Marketing, sales, and distribution expenses are aligned with our sales growth strategy, while G&A expenses are projected to grow at a moderate pace. Lastly, our corporate costs are projected to grow in line with inflation. The growth expectations for both revenues and EBITDA in our strategic plan are relatively uniform. While it's not linear, you should be reassured that this is not some back-ended exponential growth plan, relatively uniform all the way through that strategic plan period. A 7% revenue CAGR from 2024– 2029, with a circa 10% adjusted EBITDA CAGR over the same period.
As Nacho described it, a detailed bottom-up forward-leaning but realistic plan with the entire organization committed to delivering it. Over the next five years, our capital expenditure needs are clear. The company is currently very well invested and has positioned well to capture upcoming business growth. With strong demand and revenue growth projected, we estimate total CapEx needs of approximately EUR 2.5 billion over the strategic plan period. It is important to highlight that despite increasing revenue, CapEx as a percentage of revenues will decline meaningfully from 9% in 2024 to 5% in 2029. So, on average, we expect to spend EUR 500 million a year, which includes CapEx, as well as previously described extraordinary growth CapEx, which I intend to phase out in terms of our disclosure because CapEx is CapEx.
At the end of the day, we're trying to support an extraordinary growth business where CapEx is needed and includes capitalized IT and R&D. And we expect that range to be between around EUR 475–EUR 575 million in absolute quantum during this period of the strategic plan. Other areas impacting our free cash flow generation pre-M&A. Within working capital, our inventory management is a key focus with necessary investments planned through to 2029 and commencing in 2025 to support strong growth. Cost per liter, yield improvements, and supply chain efficiencies will drive inventory optimization, while debtor and creditor days are expected to remain relatively stable. Net working capital investment is projected to normalize progressively to a range of circa 3.5% of our total sales over the planned period, growing gradually up to that number from 2025 onwards, which will have a meaningfully lower percentage of sales invested in working capital.
On cash interest costs, we see a clear opportunity to reduce our interest costs by 2029, taking advantage of the strong re-rating potential as well as capital structure optimization opportunities and any benefit we get from the general rates outlook. On others, cash adjustments to adjusted EBITDA are expected to decrease. Simplification plans for non-controlling interest will be further addressed within our capital allocation framework. Finally, I want to note that the company's principal tax jurisdictions are the U.S., Ireland, Spain, and Germany. Our cash tax guidance is set at 27% of pre-tax income for the coming years. This slide gives you a feel for what is driving the significant ramp-up in free cash flow generation pre-M&A between 2024 and 2029. I compare the relative contribution, higher or lower than in 2024, for each of the building blocks comprising free cash flow generation pre-M&A.
Unsurprisingly, the key driver is our expectation for significant EBITDA growth in this period. This EBITDA already captures any negatives associated with the IRA. As we have guided to, we expect CapEx levels to subside, and absolute CapEx in 2029 is expected to be meaningfully lower than 2024. With cash interest, there is scope for it to be meaningfully lower than is the case currently, but we have been conservative with our assumptions in that regard. With lower restructuring transaction costs, the reduction of contributions from non-controlling interest, and continuing convergence of adjusted and reported EBITDA, we expect the others line to be relatively positive in 2029 in comparison to 2024. Clearly, our tax bill will increase meaningfully given our higher profitability levels.
Finally, we expect our investment in net working capital to be around 3.5% of sales, meaningfully higher than in 2024, but appropriate given industry and demand expectation characteristics. As I mentioned upfront, the combination of our expectation and confidence around significantly higher free cash flow pre-M&A conversion to adjusted EBITDA and the illustrative and implied available deleveraging capacity, it significantly increases capital allocation capacity going forward, which is a nice segue into the capital allocation section. As I mentioned at the start, our clear focus is to unlock significant value that we believe there is in the Grifols story by prioritizing free cash flow growth. In this last section, we conclude that our strategic plan that is anchored with realistic assumptions should create significant capital allocation optionality as a result of significant growth in free cash flow generation and capacity for a step change in organic deleveraging.
We intend to use that invaluable optionality in a highly disciplined manner. Our capital allocation framework has four pillars to it. Number one, balance sheet strength. We have operated as a strong Double B company highly successfully for many years, and we intend to organically re-rate back with a net leverage target of roughly three to three and a half times as defined by our credit agreement, as part of which we expect to continue reducing our net debt organically via free cash flow generation. Number two, organic business reinvestment. As I mentioned on our Q4 call yesterday, we are in an industry that has secular high growth rates, one that benefits from high profitability levels and 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. And the same holds true for R&D and digitization, where we intend to prioritize and invigorate our efforts. Number three, inorganic efforts. This strategic plan does not envisage the need for any major M&A. Of course, we create the capacity to pursue M&A if the opportunities are right from a strategic positioning standpoint and right from a shareholder return perspective. However, we do intend to consider limited corporate simplification and portfolio optimization prudently if the time and conditions are right. Number four, shareholder returns. We intend to reinstate shareholder returns from 2025 onwards.
We are confident about the trajectory and continuing strength of our balance sheet, and we have high conviction about our outlook and expect to deliver a progressive and sustainable dividend policy backed by free cash flow generation and continued organic deleveraging. As part of our shareholder returns toolkit, we also see scope for share buybacks during the course of our strategic plan. As mentioned on the previous slide, these are two corporate simplification and portfolio optimization options that are being considered in the strategic plan. We will approach each situation in a highly disciplined manner and at the right time. As you are aware, Biotest is a publicly listed company, and we own roughly 70% of the capital split between the ordinary shares and pref shares. As originally planned, our plan is to integrate Biotest, however, at the right time and under the right conditions.
Given its public listing, we are limited by what we can say other than our actions being governed by applicable laws and regulations. As you might be aware, Biotest has a couple of high potential proteins under development that are strategic to us, and the company itself is complementary from both a market and products perspective. With respect to HAMA and BPC, our current intention is to exercise our call option in 2026 or 2027. We simply need the plasma supply. It is an essential part of our plasma sourcing strategy. As has been widely discussed, we think that this corporate simplification will be positive. If we execute on these situations, we expect to finance them by free cash flow generation while continuing our deleveraging path, i.e., remaining incredibly disciplined in our approach.
Notwithstanding these situations, we expect our net leverage at the end of 2027 to be below three and a half times. Once again, reassuring all our stakeholders of our clear intention to remain highly disciplined from a capital structure standpoint. The final slide on the capital allocation topic. Rather simplistically, we show the illustrative capacity that we have during our strategic plan for shareholder returns, be it through the reinstatement of dividends from 2025 onwards and to pursue a progressive and sustainable dividend policy, as well as to consider the potential return of excess of capital to shareholders in the most efficient way, for example, via share buybacks when our balance sheet can support it. Also the significant capacity to pursue value-accretive growth opportunities to bolster our strategic position, be it in licensing opportunities or M&A.
Before my closing remarks, I'd like to briefly highlight our deep commitment to sustainability, a principle embedded in our strategy. As Nacho mentioned at the beginning of this presentation, Grifols strives to positively impact our patients, donors, and society as a whole, treating our donors and communities with the utmost respect and maintaining a best-in-class commitment to our people and the environment. Grifols is proud to have been named the number one biotech company in the Dow Jones best-in-class indices for both world and Europe rankings for four and five consecutive years, respectively. Beyond the obvious social and environmental impacts, sustainability has proven to drive improvements in our financial and operational performance as we continue to strive for ways to operate more efficiently while meeting the needs of our patients. Wrapping up my section, my key takeaways.
The bold and visionary actions from our past have given us a market-leading position in a highly attractive market that benefits from secular growth, the combination of which supports exciting free cash flow generation growth potential while continuing on our deleveraging path. Number two, deliver on potential corporate simplification and portfolio optimization opportunities that were referenced. Number three, our strategic plan implies that we expect a step change in shareholder returns while being able to support our vision for 2034. Number four, sustainability is embedded in our plan to support long-term value creation. And finally, I believe a highly attractive, if not unique, re-rating opportunity of significant scale across both our equity and debt complexes. With that, let me hand over. Oh, actually, we're going to pause for a break before Roland goes on to the value creation section supported by Nacho as well. Thank you.
Welcome back, everyone, and thank you for taking your seat. We will now resume with the final portion of our presentation. I welcome Roland and Nacho to present our value creation plan.
Thank you, Dani, and good afternoon, everyone. I appreciate you taking the time to join us today. My name is Roland Wandeler, and I serve as president of Biopharma. It has been just over a year now since I joined Grifols, and I could not agree more with what Nacho and Rahul have shared about the Grifols team. I have been incredibly impressed by the talent, dedication, and collaborative spirit of the entire organization. It is truly inspiring to see the passion and commitment that drive us forward, and it is this collective sense of purpose and mission that fuels our success.
It is in this spirit that we are excited to share with you our comprehensive value creation plan, a plan that is grounded in a thorough understanding of our growth drivers and is designed to significantly expand our company. This plan isn't just a vision. It is a clear and actionable roadmap for these coming years that will strengthen our market position and unlock substantial long-term value. As Nacho explained, we think about value creation along three core levers for our business: commercial growth, margin expansion, and pipeline execution. I'll explain these in more detail on the coming slides. These value creation levers are underpinned by two important enablers of growth. The first is our established plasma collection and manufacturing networks that will allow us to scale our business over these next years with focused CapEx investments. The second is innovation.
We will continue to drive innovation across our business, both to advance new products and offerings and to embrace new technologies and continuous improvement across our business. As Nacho presented, our strategic plan is anchored in the fundamentals of plasma economics and illustrates how a plasma company like Grifols can create value through the three core drivers: commercial growth, margin expansion, and pipeline execution. The first lever here in this graph A is commercial growth. Here, our focus is on expanding our market presence and driving sustainable revenue growth. We can build on strong market demand and our robust commercial capabilities to drive increased sales volume across our portfolio. This includes deepening our penetration in existing markets and exploring new geographies. The second lever, B here, is to lower our cost base per liter or gram of medicine.
We have a clear path to further improve our margins through optimized plasma sourcing, improved collection, as well as yield improvements and efficiencies in our manufacturing network, and the third lever, C here, is to expand our product offering through innovation. Our pipeline will allow us to launch new products as well as new indications and formulations over these next years. This helps us drive additional growth and revenue per liter and allows us to capture more of the untapped potential in our industry. Note that each component of our value creation strategy is interconnected, reinforcing the others. As we grow to meet market demand with our diverse product portfolio, improve margins, and introduce innovative new products in a concerted way, we are building a clear, compelling, and sustainable roadmap for long-term value creation. Let's take a deeper look into each of the value creation levers, starting with commercial growth.
As Rahul explained, we are starting from a strong basis. In 2024, our portfolio of leading brands generated EUR 6.1 billion and served more than 860,000 patients with chronic diseases worldwide, in addition to the more than 1.9 million patients we serve with our hyperimmunes. The strength of our portfolio is driven by our market-leading brands. 60% of our revenues today come from our comprehensive portfolio of immunoglobulins, i.e., where we see continued momentum from Gamunex with its proven track record and explosive growth from our newest subcutaneous solution, Xembify. 14% of our revenues come from our portfolio of albumin brands, where our broad offering of SKUs across vials and bags, along with our strategic partnership in China, put us in a good position for sustained growth.
26% of our revenues come from our specialty proteins, driven by Prolastin and Prolastin-C, the leading prescribed augmentation therapies for alpha-1 deficiency, and HyperRAB, the global market leader and top prescribed rabies treatment in the U.S. As Rahul highlighted earlier, we come off a strong year with 11.3% revenue growth for Biopharma in 2024, and we are well positioned to continue to drive a high single-digit CAGR over the next five years, a target we see as both realistic and attainable. This growth is enabled by high market potential across many of our indications. Looking across our IG portfolio and alpha-1, many of our indications remained undiagnosed and undertreated. We are well positioned to capture the potential in these indications with our leading brands and the progress we have made in strengthening commercial capabilities and our lifecycle management.
Plus, we start into this next period with strong momentum across our growth brands. Looking across our existing products, each protein in our portfolio plays a strategic role in driving value creation. As mentioned, IG here on the left remains our core driver for growth. This is supported by continued projected market growth, a portfolio of brands and capabilities that will allow us to grow the combination of volume and price with or ahead of market, and our ability to further improve IG yield from our collections. This is complemented in the second column here by our aim to balance our albumin growth with IG to maximize plasma economics. Global demand for albumin remains solid. In China, our partnership with Shanghai RAAS continues to provide us a competitive edge. In the U.S., we are well established with the possibility to grow further.
Outside of the U.S., we see untapped potential with room to selectively expand into new markets depending on volume and pricing. Our goal for specialty proteins in the third column is to continue to lead with both Alpha-1 and Hyperimmunes. Alpha-1 remains the cornerstone of our portfolio. We are the leader in share and our leading industry efforts to help in the identification of the many patients that are yet to be diagnosed. As global demand increases for Alpha-1 therapies, we see meaningful opportunities to expand patient access, particularly in Europe. Our hyperimmune specialty proteins continue to complement our portfolio, reinforcing our position as a trusted provider worldwide with sustained strong demand. Finally, on the very right-hand side, we have the opportunity to add new proteins to our portfolio.
In the five-year period ahead, our focus will be on the upcoming launch of our Fibrinogen concentrate, which holds the potential to redefine the standard of care in the U.S. We'll also be preparing for Trimodulin, our next protein on the horizon. Over these next slides, I will go into more detail for three of our key proteins, IG, Alpha-1 and Fibrinogen. Starting with our IG portfolio, I want to highlight the basis of our conviction for the potential to further grow. As both Nacho and Rahul have outlined, we come off a year with strong growth and momentum in 2024, with IG likely ahead of market. Looking at route of administration, the overall 15% growth of our IG portfolio was driven by a 14% increase in IVIG led by Gamunex and supplemented by over 50% year-over-year growth in our newer SCIG with Xembify, which still holds substantial potential.
From a geographic perspective, in the U.S., as our largest market, we have seen high single-digit growth in 2024, with momentum accelerating throughout the year. This was complemented by remarkable growth in our international markets, where we've seen IG revenues tripling since 2021. This is testament to our ability to drive profitable growth ex U.S. Now, looking ahead, market projections reinforce our confidence in IG as the cornerstone of our growth trajectory. The IG market is expected to grow at a steady 6%– 8% CAGR over the next five years, driven by two key factors. On the one hand, there are the market fundamentals. Despite progress over these last years, diagnosis and treatment rates remain low in many of the approved indications for IG. Looking, for example, at primary immunodeficiency, PID, only 10%– 30% of patients are diagnosed, and often only after a multi-year odyssey through health systems.
IG treatment also has potential beyond currently approved indications, with studies underway to broaden access for patients, such as for its use for secondary immunodeficiency in the U.S. And lastly, after years of supply limitations, per capita consumption outside the U.S. is still lower and underscores the strong growth potential in international markets. On the other hand, there is the unique position that IG plays as a therapy of choice in these indications. While new entrants are emerging in select indications, IG remains the primary standard of care. Given its ability to effectively address both multifactorial diseases and diverse disease origins, and with a 70-year track record of success and safety, IG is widely regarded as a therapy of choice in our key indications. Let me go into this a little bit more detail. When you look at our IG.
Sales of today, a large majority is in immunodeficiency indications and in CIDP. These are typically multifactorial diseases with significant variation across patients. Let's take a closer look at CIDP, for example. CIDP is a complex neurological condition in which the immune system mistakenly attacks the nerves, leading to inflammation, demyelination (damage to the nerve's protection coating), and axonal damage or nerve deterioration. This results in muscle weakness, numbness, and impaired mobility. Unlike well-characterized diseases, CIDP is multifactorial and is thought to involve a range of mechanisms with varying importance across patients, making treatment more challenging. This is why a very specific treatment can work well in a specific patient, but not be effective in another one.
IVIG therapy plays a crucial role in managing CIDP by working across multiple mechanisms: blocking FCRN receptors, inhibiting complement activation, modulating the cellular immune responses, neutralizing harmful antibodies, and reducing inflammation, ultimately allowing for natural restoration of nerve function. By acting on multiple pathways, different from more specific therapies such as FCRN blockers that focus on one mechanism only, IVIG is able to effectively slow disease progression and alleviate symptoms across patient populations, making it the standard of care and treatment of choice in the eyes of thought leaders. IVIG is also the only treatment not suppressing the immune system and therefore protecting the patient's health. This, together with its long track record and lower cost compared to new entrants, gives us confidence that IVIG is positioned to remain the leading treatment option for CIDP. With this, in this growing market with increasing demand for IG.
treatments, Grifols has firmly established itself as a leader in the IG protein segment and is ready to capitalize on volume expansion and supply improvements to drive sustainable growth. Over the next five years, we are well positioned to sustain high single-digit volume growth across our IG portfolio. This will be driven by our market-leading brands, Gamunex and Xembify, along with Yimmugo with its upcoming launch in the U.S. Our strategy focuses on building on our leading brands, accelerating diagnosis and treatment in immunodeficiencies, and maintaining our leadership in CIDP. Additionally, we are leveraging our global capabilities to drive profitable growth both domestically and internationally. This is underpinned by continued innovation to strengthen our existing offerings and advance our pipeline. Let's take a closer look at that. Lifecycle management is an important growth driver for Grifols.
Our approach focuses on bringing new products to market, expanding into new indications, and differentiating versus competitors. Looking at launch, we continue to expand our IG portfolio globally. Last year, we launched Xembify in nine EU countries and Australia, with plans to enter 10 or more additional markets in 2025 and 2026. Additionally, as mentioned earlier, we are particularly excited about the U.S. launch of Yimmugo, our novel IVIG protein from the Biotest portfolio. Beyond geographic expansion, we are actively pursuing new indications to maximize market opportunities. This includes the expansion of Xembify into CIDP and SID, as well as Gamunex-C into SID. Further investment in real-world evidence will continue to support the appropriate application and adoption of these therapies beyond those indications. Lastly, differentiation remains central to our strategy.
Patients are at the center of everything we do, and we continue to work on best-in-class innovations to enhance their experience. This includes Xembify in prefilled syringes, improving convenience for subcutaneous administration, and Gamunex in bags, a first-of-its-kind innovation offering an alternative to vials. To summarize, continued expansion of IG is at the core of our value creation plan. With a market poised for sustained growth and a well-positioned portfolio, we are confident in our strategy to achieve high single-digit growth in this space. Turning now to Alpha-1, Grifols has been the clear leader in this space, holding about 70% market share across markets and making it a critical pillar of our business. Our leadership is driven by our market position, our best-in-class patient support offering, and our unique testing capabilities, which we will continue to leverage as we enter the next phase of our growth.
Despite advancements in patient testing, the vast majority of the estimated 230,000 patients worldwide remain undiagnosed. We are currently identifying less than 15% of the global Alpha-1 patient population, leaving a substantial unmet need and untapped market opportunity. We believe that testing is the key to unlocking this potential, not only through traditional screening methods, but also by the rollout of our convenient point-of-care and at-home direct-to-patient screening kit. By expanding access to screening, more patients will have the opportunity to understand whether their disease progression is aggravated by Alpha-1 antitrypsin deficiency, and if so, benefit from our augmentation therapy. Raising awareness and improving diagnosis present a significant opportunity to enhance patient outcomes while driving market growth. Our plan, in that sense, is to continue to invest in this space and maintain a leading role to treat more patients. We are focused on three drivers for growth.
First, building our unique value proposition with our one-of-a-kind business model and best-in-class patient support in the U.S. Patient care is in our DNA and at the core of what we do. Second, grow the market by increasing patient screening and subsequent identification, both at the HCP and patient level. And third, increase patient access, both in the U.S. and outside of the U.S., as we work to expand reimbursement ex U.S. This is underpinned by our investment in innovation and lifecycle management. We are awaiting the readout of the SPARTA Trial at the end of 2026, the largest efficacy study in AATD, which is designed to show outcomes. With these outcomes in hand, we are in a position to enhance the payer proposition for augmentation therapy with Alpha-1, aiding patient access in the U.S., securing broader reimbursement in Europe, and enabling the launch of Prolastin-C liquid in these markets.
We are further working with leading integrated delivery networks, IDNs, to further accelerate patient identification through the application of AI algorithms across their electronic medical records. Finally, we are advancing important product innovation through our 15% Sub-Q formulation of Alpha-1, the assessment of a double dose, and the next-generation Alpha-1 therapeutic in early development. To round off our section on commercial growth, we are on track to launch Fibrinogen as a new protein in our portfolio. As you know, Fibrinogen is essential to effective clot formation. When clotting is needed, the activation of the coagulation cascade triggers the conversion of circulating Fibrinogen into fibrin strands, forming the structural framework of a blood clot. Fibrinogen concentrate is used in the prevention and treatment of bleeding in patients with congenital Fibrinogen deficiency, or CFD, a rare coagulation disorder.
The majority of Fibrinogen concentrate, though, is used in the treatment of patients with acquired Fibrinogen deficiency, or AFD, mostly associated with the management of severe bleeding, for example, in surgeries. During major bleeding episodes, Fibrinogen concentrate decreases because of the blood loss and hemodilution. It is the first clotting factor to reach critically low levels, resulting in an acquired Fibrinogen deficiency. And note that Fibrinogen deficiency is consistently associated with poor patient outcomes. AFD-related coagulopathy can only be corrected by the administration of exogenous Fibrinogen, either in the form of Fibrinogen concentrate or in the form of cryoprecipitate, a blood component that contains Fibrinogen, but also other coagulation factors. The market opportunity for Fibrinogen concentrate is estimated to be over $800 million worldwide, with significant untapped potential in key markets.
As you can see on the right-hand side of the chart, Fibrinogen concentrate has been embraced as the preferred source of Fibrinogen in bleeding management in markets like Germany and Austria, with per capita use of three to five grams per thousand inhabitants. On the other end of the spectrum, there is huge opportunity for adoption in the U.S. and U.K., where Fibrinogen concentrate use today is 10- to 15-fold lower, and where cryoprecipitate is currently the standard of care. This is where a large market opportunity lies: the adoption of Fibrinogen concentrate as the new standard of care for bleeding in the U.S. As a reference for such a change, we can look to Canada, where market adoption has been gaining progressive traction since 2020, when Fibrinogen concentrate was introduced as the new standard of care over Cryo.
The benefits of Fibrinogen concentrate in efficiently treating patients with CFD and AFD are clear compared to cryoprecipitate, allowing for a targeted, rapid, and convenient correction of Fibrinogen levels. Further, we are developing our next generation of product to be storable at room temperature, more convenient to use, and faster to prepare compared to existing Fibrinogen concentrates on the market. We are on track with our preparations to launch our Fibrinogen concentrate once approved. From a regulatory perspective, we have completed submissions of the regulatory dossier in Europe and the biologics license application in the U.S. We just heard back from the FDA that our BLA was accepted, with a PDUFA date of December 27, 2025. We are excited to share our study results in more detail in the course of this year and expect the first European launch towards the end of the year.
We successfully expect to launch in the U.S. in the first half of 2026. Looking at our commercial opportunity, we will position our Fibrinogen concentrate as a differentiated therapy, given its clinical profile and offering. We aim to introduce our Fibrinogen concentrate as a new standard of care in the U.S. as a new market and to gain share in established markets. This will be supported by continued work to expand the body of evidence. In short, we don't see this just as our next launch, but rather as an opportunity to advance clinical practice with a differentiated therapy that is setting a new standard of care within the U.S. We believe that Grifols is well positioned to be a leader in Fibrinogen.
While commercial growth is undoubtedly an important driver of value creation over the next few years, margin expansion is equally important and offers significant potential to unlock value. To achieve our plan over the next five years, we are focusing on three levers to drive margin expansion. First, plasma sourcing mix, a key competitive advantage for us. Our extensive and geographically diverse plasma collection network allows us to optimize sourcing and maintain a stable, reliable supply to meet global growing demand. Second, plasma collection excellence. This will be driven by operational improvements, donor-focused initiatives, and advancements in plasma yield technology. These efforts are aimed at further reducing the total cost per liter while ensuring efficiency and sustainability. And finally, we have a path to further enhance yield and drive manufacturing efficiencies across our industrial and production facilities to maximize output and cost-effectiveness.
Let's take a deeper look at each of these areas, starting with plasma sourcing mix. Thanks to the strategic investment in our network over the past few years, Grifols has built an extensive global plasma center network. This network provides the scale and diversification needed to meet growing demand without requiring significant capital expenditure in the near future, while also offering room to further enhance productivity within our existing footprint. While the U.S. remains the cornerstone of plasma collection, and we continue to optimize our U.S. centers for efficiency and volume, we have strategically expanded our international presence. Today, over a quarter of our donor centers are located outside the U.S. in key regions such as the EU, Egypt, and Canada, representing the industry's most diversified plasma collection network.
This puts us in a strong position to optimize plasma sourcing and distribution, collecting plasma more cost-effectively while ensuring supply aligns with the key end markets. This approach is particularly critical as we continue to enhance volume creation, drive profitable international growth, and support countries seeking to increase self-sufficiency in plasma derivatives. Our second level for margin expansion is excellence in our plasma collection. Over the last several years, my colleague Jordi Valsells and his team have made great progress in this area and unlocked impressive value. Jordi and team have rationalized our collection network, consolidating and relocating centers to ensure efficient fleet management. They have streamlined the organization and optimized operations by having better-performing centers in the right locations and with volumes that support sustainable growth at scale.
They have optimized donor compensation as a key component of driving plasma volume while containing costs, and they have made progress in rolling out our improved individualized nomogram technology within the U.S., which I will detail shortly. As a result of these efforts, we have been able to successfully lower our cost per liter closer to pre-pandemic levels when adjusted for inflation, with further room for improvement. While we've made good progress on all plasma collection fronts, we see room to further reduce the cost per liter through our four key drivers as part of our strategic plan to unlock additional value. Given our current well-invested network of donor centers, our first goal is to increase the volume of collections per center through improved donor retention and capacity management across our network.
Specifically, we will be expanding our compensation initiatives, leveraging technology and smart data analytics to increase incentives and improve digitally enabled donor experiences. This will allow us to better tailor fee strategies to market conditions and make them more relevant to loyal donors. Additionally, Jordi and his team are driving operational excellence by improving overall donor service and streamlining operations across all our centers, focusing on enhancing throughput times and plasma yield at optimal staffing levels. Lastly, we will continue to expand the implementation of our improved individualized nomogram across the U.S., which will enable us to improve our plasma yield significantly. Let me expand on this last point. The implementation of nomogram technology has an important impact on enabling higher collection.
Through the individualized nomogram technology, instead of collecting plasma volume solely based on a weight range, we are now able to factor in the height, BMI, and hematocrit of an individual donor in order to calculate the amount of plasma that can be safely collected. The net effect across all donors is an improvement in volume yield in the mid to high single digits. To date, our plasma team has successfully implemented this in 60% of our U.S. donor centers and are on track to get to 100% in the U.S. between this year and next. We are also reviewing opportunities to expand implementation to our donor centers outside of the U.S. We are very excited about the potential of this new technology and the early impact we are already seeing to drive lower CPL and expanded margins, which will be reflected in our P&L later this year onward.
Finally, going to our third lever for margin expansion, the increase in end-to-end IVIG yield and efficiencies across our entire value chain, from donation to vial. Over the past year, we have been able to improve our manufacturing processes in a way that already delivers a 5% IVIG yield increase compared to our 2023 baseline. As we look into the future, in the short term, one to four years, we see further opportunities to optimize our end-to-end processes, bringing our yield improvement up 10% relative to our baseline. In the midterm, three to seven years, we have a clear roadmap to further enhance our collection and manufacturing processes with additional improvements for Gamunex, aiming for a 20% or more yield increase over time versus our 2023 baseline.
Finally, beyond seven years, we're actively developing next-generation technology beyond the traditional fractionation and purification process, designed to drive yield improvements exceeding 30% compared to our 2023 baseline, reinforcing our long-term commitment to efficiency, innovation, and sustainable growth. In addition to enhancing our manufacturing yield, we remain committed to driving efficiencies and continuous improvement across our operations. As you may recall, since launching our operational improvement plan in 2023, Grifols has achieved significant cost savings across key areas, including biopharma manufacturing, plasma operations, and procurement. We are committed to build on our capabilities and insights from this process. We continue to foster a culture of continuous improvement, which empowers our teams to identify and capture efficiencies and enhance both yield and productivity while freeing resources for reinvestment.
We believe that with these three levers, plasma sourcing mix, plasma collection excellence, and yield and manufacturing efficiencies, we have a clear path to expand our margin over the next five years. And finally, our third value creation lever, pipeline execution, ensures that we accelerate the time to market for lifecycle management and new products that support our growth. This is one of the priorities of our colleague Jörg Schütrumpf and his team in our Grifols Active Innovation Office SIO. In the SIO, Jörg brings together our company's research and development efforts under one unified structure, enabling strategic project prioritization and fostering global collaboration across teams. Our focus over these last years has been to strengthen our portfolio and innovation engine along three priorities. First, to set the right basis, we have undertaken a strategic portfolio review to streamline and prioritize our pipeline.
This has sharpened our focus on core therapeutic areas and enabled us to reallocate over EUR 120 million towards pipeline projects with the highest growth potential, particularly in IVIG therapies. Second, Jörg and team have focused on accelerating time to market for these key programs, both lifecycle management initiatives and new product launch. And third, we have invested to strengthen our capabilities across our R&D value chain. This focused approach, coupled with enhanced cross-functional collaboration, is making our R&D team more agile and efficient. As a result, our pipeline efforts are focused on driving traction across lifecycle management, new products, and yield optimization. As for lifecycle management, our focus is on improving our product offering and expanding into new indications with IVIG and Alpha-1 to serve more patients.
This includes Xembify pre-filled syringes and Gamunex in bags as new formulations, the expansion of Xembify and Gamunex into secondary immuno deficiency, expanding Xembify to CIDP, as well as the development of a 15% subQ formulation in Alpha-1, all aimed at strengthening our offering and broadening treatment options. As for new products, we are advancing our pipeline with potential breakthrough therapies, including Fibrinogen and Trimodulin, as well as exploring new uses, such as with IVIG in dry IDCs. In addition to plasma, this is where we also advance our promising recombinant polyclonal platform with GigaGen, which Nacho will cover later in our presentation. In addition, as outlined earlier, we continue to drive innovation to further increase yield. We are continuously refining our plasma and manufacturing processes, from short-term process improvements to the long-term development of next-generation technologies to optimize IVIG production.
Across these three levers, our pipeline execution will support our value creation over the next five years. Now, looking at these three levers, our projected growth over these next five years is enabled by our ability to effectively scale plasma supply and manufacturing capacity. Starting with plasma supply. As mentioned earlier, our strategic investment in donation centers has enabled us to build an extensive and diversified network. This network holds significant intrinsic value, providing a reliable and well-diversified plasma supply with ample room for scaling and expansion, all without requiring significant additional investment. With a clear focus on increasing plasma collections per center, our volume and yield improvement initiatives are fundamental to both our growth strategy and margin expansion. Additionally, I want to highlight our strategic geographic expansion efforts, which include doubling our plasma network in Egypt and completing our network in Canada this year.
These partnerships not only strengthen our global footprint, but also contribute to self-sufficiency in key markets. Finally, our geographic diversification helps mitigate supply chain risks while also creating opportunities to lower plasma collection costs through operational efficiencies. Similarly, our manufacturing footprint is well invested and diversified, with capacity to support growth within our existing facilities over the next several years. With six manufacturing sites across North America and Europe, we maintain broad capabilities across product lines, allowing us to meet demand while remaining flexible and efficient. We have recently invested to our capacity, mainly in Clayton, Montreal, and Dublin, and will deploy focused investments to maximize current potential in our main plants in Barcelona, Clayton, and LA. In addition, we will complete our capacity expansion in Montreal, where development is on track, and our increasing albumin production capacity at our Dublin plant.
Overall, our existing manufacturing footprint allows for targeted CapEx investments to increase capacity while also paving the way for the next wave of major expansion beyond 2030 to support future growth. Now, in addition to securing supply in plasma manufacturing to enable growth, continued innovation is also a key enabler for long-term success in our value creation plan. When it comes to innovation, we are guided by a strategic framework that looks across the origin of our medicines and our four core therapeutic areas, always with the aim to make a difference for patients. Starting with the origin of our medicine, plasma is our legacy and our core. It is a raw material we already collect. We have extensive expertise in this area, and plasma continues to hold significant future potential. In short, plasma is our priority for value maximization over these next five years.
Today, we operate in four main therapeutic areas with our plasma medicines: immunology and autoimmune diseases, infectious diseases, pulmonology, and critical care. We see clear opportunities to expand and enhance our plasma-based offerings in these areas through lifecycle management and new proteins such as Fibrinogen and Trimodulin, as well as to opportunistically explore potential beyond, such as with IG in dry eye disease. We will continue to innovate and strengthen our plasma-derived portfolio to fuel business growth. But in addition to plasma, we aim to leverage our expertise in the indications we treat and our understanding of protein pathways to complement our portfolio with non-plasma-derived medicines in a targeted way and exemplified by our GigaGen platform. In short, with our expertise in plasma and our therapeutic focus, we see opportunities to expand our portfolio both within plasma and into plasma-adjacent areas.
Our established infrastructure enables us to develop and distribute novel therapies with our existing workforce and drive synergies across our end-to-end process. This approach to innovation is reflected in our pipeline as we continue to pursue high-value opportunities that maximize both patient impact and business growth across our therapeutic areas. Starting with our assets closer to market on the right-hand side on this chart in phase three, regulatory and product development, you see important plasma programs across all four areas. We already mentioned the importance of lifecycle management for IVIG and immunology, which will help us to grow with or ahead of the market. In pulmonology, the evidence we will gain from SPARTA will allow us to further bolster growth with Alpha-1. The upcoming launch of Fibrinogen in critical care will help us evolve the standard of care in bleeding management in the U.S.
Further, I will be happy to share with you in a moment some highlights of our phase three program with Trimodulin in SCAP and infectious disease. In the early stages of development, our pipeline includes both a broad range of plasma-specific programs as well as a significant number of non-plasma assets. As you can see on the left-hand side, in immunology and autoimmune, we have projects focused on next-generation Gamunex, recombinant treatments, and the focus of IG in dry eye disease. Within infectious disease, we are developing recombinant therapies for various infectious diseases and HPV, as well as exploring new indications for Trimodulin, which I will discuss in more detail in the coming slides. Our pulmonology pipeline continues to focus on lifecycle management for Alpha-1 and the development of next-generation therapies in this space.
Note that these non-plasma assets on the left-hand side function in a similar way to plasma, which allows us to fully leverage our existing knowledge base and network to support discovery and innovation in these areas. In this context, we are particularly excited about our GigaGen platform, which Jörg will highlight in more detail in a bit. As mentioned earlier, the focus of Jörg with his team is to accelerate time to market for our key projects. Over the past three years, we have reaped the benefits of our innovation efforts, successfully achieving all of our 2024 innovation milestones. This includes key geographic launches for Xembify and Prolastin, as well as label expansion for Xembify and a label change for fibrin sealant.
Looking ahead to the next five years, we have a promising pipeline of innovations across both existing and new therapies, all of which will support our five-year value creation plan. In the near term, we are preparing for the launch of Fibrinogen and Gamunex in bags, two critical advancements that will enhance our portfolio. Beyond that, through 2029, we plan to complete the SPARTA efficacy trial for Alpha-1, expand Xembify into SID, introduce our 15% subcutaneous Alpha-1 therapy, and advance the launch of Trimodulin, which I will expand on shortly. Zooming in on our specific innovation milestones for 2025, we aim to maintain our momentum.
In the first half of the year, we expect to launch phase 1B of the GigaOncology program and enroll our first patient for the dose expansion part of our trial and to submit our phase 2 IND application for ocular surface IG in dry eye disease. In the second half of the year, within IG, we plan to submit the IND application for Xembify and CIDP, as well as our FDA application for Gamunex in bags. Further, we anticipate top-line results from the phase 1-2 trial of our 15% subQ Alpha-1 administration, EU and U.S. approval for our Fibrinogen treatment for congenital and acquired deficiencies, and we expect to reach 25% patient enrollment in the GigaHBV trial by the end of 2025. We look forward to sharing progress on these upcoming milestones and see a long runway for growth and value creation across our pipeline.
Before turning it to Nacho to expand on our innovation in addition to plasma, let me briefly highlight the potential we see with Trimodulin as future medicine in our plasma portfolio. Trimodulin is a unique and innovative IG treatment. Different from standard IG preparations, IVIG and SCIG, Trimodulin combines IG with a mix of IgM and IgA. This gives Trimodulin a triple mechanism of action, enabling the therapy to clear pathogens, neutralize toxins, and modulate uncontrolled hyperinflammatory response, which is very relevant in serious infections and in particular for our lead indication of severe community-acquired pneumonia or SCAP. SCAP is a condition with high mortality and significant unmet medical need. Following a post-hoc evaluation of our phase 2 SIGMA study, we found that there was a significant reduction in mortality within a subset of the trial population, those patients with high levels of C-reactive protein and/or low levels of IgM.
When used in conjunction with an anti-inflammatory and antibiotic, Trimodulin rapidly normalized these protein levels and lowered mortality rates. With these initial findings, we got positive feedback from regulators and clinical experts to launch our phase 3 trial with this specific population. With the ongoing recruitment of our phase 3 clinical trial in SCAP, we are working to bring a medicine to market that can benefit around 300,000 patients suffering from this condition annually worldwide and in addition to SCAP, Trimodulin's triple mechanism of action suggests significant potential in other indications such as sepsis. Note that there are nearly 1 million patients with severe infections in ICUs, where the very high mortality rate continues to represent a significant unmet medical need. Trimodulin does present the potential of a pipeline within a product, and we will look to expand our clinical development program accordingly.
We are excited about the innovation that Jörg and team are driving both within plasma and in addition to plasma. Trimodulin is certainly one of the highlights as new plasma medicine, where Grifols stands out as an early mover, positioning us to capture a substantial segment of this potential market, but let me hand the floor back to Nacho, who will walk you through the potential we see in our innovation platforms outside of plasma. Nacho. Thank you, Roland. Thank you, Roland, for your in-depth overview of our value creation plan. Two of the innovation platforms, mentioning GigaGen and Chronos PD, I think deserve further exploration. These projects illustrate how we leverage our expertise to develop next-generation medicines that go beyond plasma-derived therapies.
On this slide, GigaGen is a cutting-edge technology that enables the production of both polyclonal and monoclonal antibodies through recombinant DNA technology, specially engineered to target disease-causing agents in areas such as infectious disease, cancer, and immunodeficiencies. In 2024, this technology has delivered already on important breakthrough milestones. In oncology, we have treated the first patient in a phase 1 trial on a novel antibody designed to enhance tumor-killing activity while minimizing immune-related side effects. This trial is supported by the U.S. National Cancer Institute. In infectious diseases, we have initiated a phase 1 trial targeting chronic hepatitis B with the intention to develop a curative treatment of the disease. This trial is an important milestone not only for the specific disease, but because it validates the entire polyclonal antibody platform for human use.
In biodefense, we established a partnership with BARDA in the U.S., which awarded up to $135 million U.S. dollars to develop a treatment against highly toxic substances that can cause progressive muscle paralysis and one other not yet specified target. This is the first step for the platform, which could serve to develop countermeasures against multiple emerging biological threats and emerging pathogens in the future. Looking ahead to 2025, we plan to further expand the GigaGen pipeline with multiple new targets in both infectious diseases and immunodeficiencies. We also continue to invest in innovation through Chronos, which leverages our extensive plasma collection and experience in AI and large data processing and cutting-edge proteomics to advance personalized medicine. Let me explain that. Grifols maintains one of the world's largest plasma sample inventories, with over 100 million samples collected over 15 years.
This data set presents an opportunity to revolutionize disease detection, potentially identifying conditions before symptoms even appear, a crucial step towards proactive healthcare and improved patient outcomes. A clear example of this potential is Chronos PD, our Parkinson's Disease Initiative, supported by a grant from the Michael J. Fox Foundation. This platform aims to identify plasma-based biomarkers that could predict Parkinson's disease a year before clinical symptoms emerge and to track plasma protein evolution in PD patients, potentially leading to earlier intervention, better treatment options, and disease-modifying strategies. We anticipate initial results in Q2 2025, marking a critical step toward new diagnostic tools and therapeutic advancements. Beyond Parkinson's, Chronos presents broad potential for collaborations that could drive groundbreaking diagnostic and therapeutic solutions and improve disease management across multiple therapeutic areas. Now, I will turn to our diagnostics division. Diagnostics complements our core biopharma business and fosters growth in synergies.
Financially, diagnostics is highly profitable and generates a strong free cash flow conversion. Our strategy for diagnostics is clear. Building on our leadership in blood typing solutions and molecular donor screening, we aim to solidify our leadership in transfusion medicine while expanding into the broader clinical diagnostics market. In the large in vitro diagnostics markets in 2024, transfusion medicine played a critical role in ensuring the safe and effective supply of blood and plasma. Grifols is a major player in this field with a strong market presence and significant white space opportunities. Our approach in blood typing solutions focuses on achieving double-digit growth by concentrating on core markets, improving margins to enhance efficiency and advance next-generation technologies. Meanwhile, our efforts in molecular donor screening center on the lifecycle management of Procleix Panther, strengthening strategic accounts and developing next-generation nucleic acid testing technology.
We are also working on innovative screening technologies in the immunoassay donor screening area. The development of these new platforms in molecular and immunoassay will not only consolidate our leadership, but also expand our presence in clinical diagnostics, a market in which we are barely present today. In parallel, diagnostics will continue providing disruptive selection to support the detection of underdiagnosed pathologies for which Biopharma has a therapy available. A successful example of this support is the Alpha-1 program for the detection of Alpha-1 antitrypsin deficiency, a disease in which only 15% of patients are diagnosed. Our diagnostics division is poised for significant growth in the future, driven by the three innovative platforms currently in advanced development.
The Barcelona platform in blood typing solutions, expected to launch in 2026, integrates state-of-the-art gel card technology, modular design, and is able to connect to an automated track to improve accuracy and efficiency in blood typing. In the immunoassay screening space, the upcoming Isard immunoassay platform is slated for a 2029 launch, employs multiplexing and ultrasensitive technology, positioning the company to enter the billion-dollar serology donor screening market. Finally, the Mundaka molecular platform, scheduled for launch in 2030, incorporates advanced multiplexers and ultrasensitive detection, further solidifying Grifols' leadership in NAT donor screening. These cutting-edge platforms will enable us to capitalize on growth opportunities in transfusion medicine while strengthening our position and driving long-term value creation in clinical diagnostics. In summary, I am incredibly confident in our value creation plan and its potential to propel us toward achieving the goals outlined in our five-year strategy and 10-year vision.
I hope we have successfully shared in detail our clear and well-defined path, which I would like to briefly summarize before concluding. First, the robust and growing demand for plasma-derived therapies across diverse indications presents a clear pathway for sustained growth. We will leverage our scale and capabilities to execute our clear plan for IG expansion, maximize our output of other proteins, and successfully launch fibrinogen, positioning us perfectly to meet market demand and capture significant market share. Second, we recognize that profitability is a critical engine that will fuel our long-term success. By focusing on optimizing our plasma sourcing mix, achieving collection excellence, and maximizing both yield and manufacturing efficiencies, we will unlock substantial profitability gains. Third, we have made the strategic investments to support our future growth trajectory.
Our current network of plasma centers and manufacturing plants provides a solid foundation to support the opportunities in front of us. We concurrently maximize our fractionation capacity, thus ensuring we are not limited in supply nor capacity to efficiently meet the increasing needs of the market. Finally, we are committed to accelerating the execution of our R&D pipeline, both through lifecycle management of existing products and the development of innovative new ones. Furthermore, we are exploring new value creation models, exemplified by our promising ventures like GigaGen and Chronos, which will ensure continued industry leadership and create further value in the future. I would like to conclude this Capital Markets Day by reiterating a few points that we have already made, but they bear repeating. Our foundation is built on a clear strategy, backed by strong fundamentals and strengthened corporate governance and senior management team.
The entire executive team is focused on accelerating the execution of the company's strategic plan, delivering sustainable growth, financial discipline, operational excellence, innovation, cash flow improvement, and deleveraging, and reinforcing our leadership position in a high-potential industry. Our capital allocation discipline will be key. We will continue prioritizing free cash flow growth and deleveraging, ensuring that every euro is strategically invested to maximize returns. In parallel, as Rahul has mentioned, we are committed to corporate simplification and portfolio optimization, enabling us to streamline operations and focus on those businesses that drive the most value. Beyond financial performance, we are deeply committed to operational efficiency and continuous improvement. We continue to foster a culture of optimization and improved productivity while allocating resources for reinvestment and long-term growth. Ultimately, we aim to increase value for all of our stakeholders. We have a clear opportunity to drive a substantial re-rating of our story.
We look forward to communicating with you in new and meaningful ways, building a long-term relation, and I am sure successful. I am excited with this journey ahead of us and grateful for your continued support of Grifols. Thank you all for your attention today here in London or virtually. Your time and support are really appreciated. Danny, please. Thank you.
Thank you, Nacho, and also thank you, Rahul and Roland, for your presentations. It was a lot of information we covered this afternoon, but I'm sure that there are a number of questions, a lot of questions, probably. We will now open the session for the Q&A. It's going to take pretty much kind of like one hour. So please, before that, please provide for the participants here, sorry, raise your hand and we will come around to you with a microphone.
But we need that you provide your name and institution you represent. Please limit your questions to no more than two. But also for those participants that are attending virtually, please submit your questions in writing through the chat box in the webcast. Thank you.
Hi, I'm Charles Stefansen King from Barclays. Just to start us off, a question on Alpha-1 antitrypsin. One of the key concerns of investors this year is the impending trial data from Sanofi. So I was just wondering if you could elaborate a little bit on your strategy to offset any potential competition within the space. Are you looking at any potential reformulation of your product as an inhaled product, similar to Kamada's in development? Could that improve prevalence in the lungs?
And then just finally, in terms of the double dose of the SPARTA trial to support your margin expansion, I was wondering how this impacts the balancing of your liter of plasma should it be effective. Thank you.
I think Roland would love to answer that question.
Yes, yes. As you say, Charles, still early days, so we're also looking forward to seeing the clinical trial data. The one thing still to keep in mind always is just the huge opportunity that's there to treat all those patients that are yet to be diagnosed. I hope I was able to outline before our efforts. One is with our SPARTA trial, we will have an opportunity for the first time to actually show outcomes for a therapy with augmentation.
And we believe that this will not only help us to further convince physicians that today may still be on the fence and are waiting for outcomes data, but also ease access in the U.S. and expand internationally, which will be taking a bit longer for new entrants. When you look at reformulations, the part that we talked about today is the 15% sub-Q. Our market research actually indicates that there's a high interest from both patients and providers in a sub-Q formulation, given that this just gives more independence. And we're developing that. And we also, still early days, we're talking about an innovation beyond of an offering that we believe will add value. And we will be disclosing more in time of our next-generation product that will be plasma-derived, but will have properties that we believe will be attractive. So we continue to invest. We're not standing still.
We make sure that we can actually improve our offering, use the evidence that we'll have from Sparta to ensure access, and make sure that more patients are diagnosed and treated.
Thank you. And then just a second question on the five-year targets and plasma sourcing. I was just wondering if you could confirm that when you say your existing network is sufficient to support growth, this includes any expected increase in utilization of the current sites, your yield and product mix improvements, but also bringing previously announced new facilities into the fold, such as those ImmunoTek assets that you are committed to purchase this year and next, as well as the completion of your Egypt and Canada programs. Maybe just touching a little bit on utilization of your current established network.
Well, I think you summarized it in the very right way.
So I think that with the completion of the acquisition of the ImmunoTek centers and the additional centers we're planning to build in Egypt, I think we will be quite well served for the next years to come. Then the focus will turn into increased productivity of those centers by generating more plasma. We know we can do that. I mean, the analysis has been done. And I think with the current donation center footprint that we have today, I think we are well presented for the next two, three years, and then three, four years from now is when we're going to start the next wave of donor center expansion. Thank you.
Thank you, Charles. We have a second question. James, please. Oh, I said James, but I mean, Giger made it fine.
Okay. Thank you for taking my question. So the first one on margins.
So outside of the efforts to improve yields and sourcing in Grifols', having been in the DNA of the company for over the past decade, and we haven't seen always an improvement in margin, at least the margin improvement that we would like to see. So what kind of indications, additional indications that you can provide us that could back this margin improvement target that you're pointing out?
I can take the first question and you can complement, but I think that over, I mean, if you analyze the last few years of the history of Grifols', I think that we have done a lot of work in order to improve our margins. I think that probably the most obvious, the most visible one is the cost per liter.
I mean, the cost of our most relevant raw material, which has significantly been optimized over the last years after the COVID time, but not the only one, right? So we continue working on yield optimization. We have a number of activities working on that in the short, in the mid, and in the long term, as Roland has explained. And we're seeing that. We're seeing already that progress in 2023, 2024, and we will continue seeing that in 2025. I don't know if there is anything else to add.
The only thing I would add to that is if you look at our historic margin growth at the EBITDA margin level in the last couple of years, it's been a couple hundred basis points a year, right? And that's just normalizing of our operations, as it were, coming out of the pandemic.
As I look at the go-forward picture, we've already been clear about the impact of OpEx as a percentage of sales. We're pretty good where we are at that front, and a large part of it is gross margin. And of course, one of the key drivers of that, Nacho has already mentioned in terms of CPL. Yield improvement is clearly another one. If you just go back and look at Biotest, that, again, we remain very positive about in terms of outlook and the proteins coming through and so on. You can just track the impact of Biotest on gross margin. So just there, there's some normalization that will come over time. So that together with some of the other product launches and so on will allow you to get back to those pre-COVID margin levels that I guided to.
Okay, thank you.
The second question, how should we think about the timing for monetization of these longer-term projects that you have in Egypt and Canada? How should we think about the timing of monetization? So far, they are consuming cash. So when we should see perhaps connection with the optimization of the plasma donor network, when should we see these projects starting to bring some benefits visible on the P&L?
I would say that those projects, both projects in both in Canada and Egypt, they are well advanced. So I think that soon they will enter in the phase where they will not consume cash, but deliver cash, I would say.
I think really when we think in the plasma industry and about the innovation that we always talk about, which is normally related to R&D and scientific innovation, there is also a lot of possibilities as well to create innovation in the business model. And I think the Canada case or the Egyptian case, they are clearly innovations in the business model in the plasma world. First of all, I think that is always driven by an interest in the country to generate a self-sufficiency project, which we believe, and it's a very important one. But obviously, it's a win-win. It's a win-win for the different governments which are involved in that. It's a win-win for us. It requires some CapEx upfront. I would say in our case, most of that CapEx has been already deployed. So from here, we need to continue executing on the different milestones.
Very soon, obviously, in the five-year plan that we have outlined, we will see the benefits of those projects.
Thanks. James Gordon from JP Morgan. Two questions, please. One was about guidance and the trajectory of the improvements that you're going to make. So the 2029 guide is really useful on revenues, EBITDA, and free cash flow. Did you say it would be linear for the progress of most of these metrics, or might it be a bit back-loaded? Because I wonder why have you shifted from a 2027 guide to a 2029 guide? Is that because some of the benefits are going to be a bit further out? And sort of connected to that, in terms of where do you think you might be in 2026? Because you highlighted there's about EUR 3 billion to be refinanced or repaid in the year 2027.
And I think normally people want to refinance ahead of it. So is it sort of a linear progress, and in 2026, you'd be all on that path and in a much better position for refinancing? Maybe I'll do that as the first question, then ask the second question.
Yeah, let me take both those questions. So I said it is not linear, but I said relatively uniform. So it's not a back-ended exponential growth plan, right? So super clear around that. Why have we not provided 2026? I mean, it's unusual for companies to provide guidance for the next five years, right? I mean, we are doing that, and what we're saying is that whilst providing relatively granular, again, very unusual for companies to provide bottom-line free cash flow pre-M&A. So we're being super clear in terms of our expectations with the market. So address the first question.
Your second question deals with refinancing. So my refinancing risk is in 2027, Q4 2027, as you said. It's EUR 3 billion, give or take. It's secured refinancing. What's my secured leverage today? 2.7x . It's a layup trade. Honestly, it's a layup trade. I'm not worried about the refinancing risk one bit. The key question around the refinancing is the optimizing of the refinancing conditions. And as you think about that, it's all about rate risk and so on. And as you think about that, clearly, we've got the re-rating potential that will come through. Remember, beyond that, yes, there are other maturities as well. We've got a significant amount of secured capacity, which helps your rate risk as well.
Also, I would say today, if you look at where U.S. dollar rates are, it's depending on what measure you look at, anywhere between the 85th percentile and 95th percentile. Is it going to stay that long for the next five years? I don't think so. So all I'm saying is I'm not worried about refinancing risk. We've got a number of levers to play with. And certainly, as you look at the strategic plan coming through, given our focus on deleveraging, given the focus on free cash flow generation, the re-rating potential there, frankly, is there. So I'm not at all concerned around the refinancing. So I don't feel the need at this stage. Of course, we will provide annual guidance as we normally do. I don't feel the need at this stage to go further than that.
Thank you.
The second question was about capital allocation and returns. I think I heard you mention that buybacks could be a possibility. So if you did a buyback, would you buy back both share classes at the same price, or there's a structure where you could buy them back at different prices? And is it simplified because you might do a share class collapse ahead of doing a buyback? So is that something you're considering doing? Or when you say, would that be part of corporate simplification, or is that more just like HEMO, BPL, and Biotest?
Yeah. Okay. Let me take the first, and of course, Nacho, feel free to add around the share class collapse and so on. As I talk about share buybacks, it's simply, obviously, you want a balance sheet in the right place.
And the key message is, based on what we've talked about today, the capacity for the balance sheet to be in more than the right place is immense. And as a result of that, the simple message is that we will find the most efficient way to return capital if there isn't a more either strategically important or shareholder return-driven action that we can take within the company. And that's the simple reference. It hasn't gone as far as, is it going to be Class A, Class B, and so on. And around the share.
There is the collapse of the Class A and Class B. It's not in the table right now. I think the laws are clear on the fact that the A's and B's will have equal treatment in the market.
The laws are there, and there is no plan at this point to collapse A and B's.
Thank you.
Back in the queue.
Thank you, James. We got pretty much the same question online from Jim Hoffman of Paulson. So I think that it has been well covered. More questions, please. Please. The gentleman on the third row.
Santiago Herrero from Sparta Capital. First, I want to congratulate you on a superbly executed capital markets day. So thank you very much for doing this for all of us. My first question is quite simple. Your IG franchise has grown 15%, sorry. Yet I think the guidance is 6%–8%. So I wonder if you can give a little bit more color for, I'm sure there are good reasons for that.
Yeah, look, what I was trying to say, and then Roland, you can add to it, is if you look at the last couple of years, we believe we've grown meaningfully faster than the market, right? And the strategic plan that we've outlined here is certainly anchored with pretty realistic assumptions in terms of market growth. And I did guide to us growing at the high end of the market growth expectations. Is there upside to that, perhaps? But at the end of the day, we're also managing a number of things from a business standpoint that we want to make sure that we're measured in rather than promising you guys the moon and then underwhelming. So that's what I would say. But Roland, I don't know if you.
Yeah, the 6%–8% range is the one that you generally see.
We believe a lot in the potential of IG. As I said, we believe that we can grow with or ahead of the market, which, as you outlined, puts us into this high single-digit range, which would be at the upper end of the 6%–8%.
Thank you very much. Second question regarding the IRA, how certain is that? Because you've highlighted a little bit of risk there. Is that something that you think has some potential to improve or worsen? Thank you.
A lot has been said in the IRA environment before, but with other companies. There is a lot. We feel that there is a lot of skepticism out there about IRA and the real impact.
This is precisely why we provided a guidance before IRA, and then we provided the range for what we believe IRA is going to be impacting, right? So essentially, we have done our internal analysis, and we have worked with external consultants as well in order to narrow as much as we could the potential impact of IRA. There's one variable of IRA, which is essentially not in our hands, which is if those medicines are going to be through the pharmacy benefit or the hospital benefit in the United States, and it's not in our hands to control. That can have some variability. We believe the range we have provided is the right one. IRA is just being implemented since January 1st in the U.S., and we will monitor through the year.
I think a lot of work has been done in order to narrow as much as possible that expectation.
And perhaps Nacho is just taking a step back. IRA has different parts of the Part B, Part D. The part around drug negotiation has been already in the market. I'm sure you're all covering other companies that have been impacted. We're excluded. Plasma derived therapies are not impact negotiation, so they didn't exclude us. The inflation cap in price increase, as Rahul explained, that's already our practice factored in. The new part is starting January 1, 2025, the Part D redesign. And as Nacho said, I think the part that is special for us is that our medicines can be covered under Part D and medical benefit. And so it will depend on the number. But I think the guidance we gave is a range one.
Okay. Thank you. It was very clear.
Tom, please.
Hi. It's Tom Jones from Berenberg. I have a question on growth and cash flow. This industry is a funny beast in that it's quite possible to maximize earnings growth, and it's quite possible to maximize free cash flow generation, but it's very, very difficult to optimize both at the same time, and I think you alluded to that with your balanced approach. The question I have, you don't operate in a vacuum. You operate against two very large competitors who have two very large, very cash-generative businesses bolted onto the side of their plasma business. So I guess my question is, how confident are you that where you've set that balance between earnings growth and cash flow generation is not going to leave you competitively disadvantaged at some point? Because ultimately, cash and the balance sheet and working capital is a competitive advantage. You carry more inventory.
You offer better terms. You get more business. Thinking about it, what confidence can you give us, or what sort of color can you give us in how you've thought about this to ensure that where you think you've set it or why you think the level you've set it at is the most competitive one for you over the long, the medium, and short term? And that's the other angle to it. You can juice one or the other short term, but then you leave yourself in a bit of a pickle 5, 10 years down the line, which is Grifols' is obviously a very long-term view. Has that changed at all in terms of how you're thinking about things?
I mean, I'm sure Rahul can offer a more technical explanation.
What I would say is that what you have described is the essence and the magic of managing the plasma derived medicines business, right? So that's exactly what it is. It's a business that requires some significant CapEx if you want to grow the top line, grow the business. And that's consumed cash. And at the same time, we want and have the obligation to deliver on good free cash conversion. So I think it's all about balancing that continuously. And this is exactly what, I mean, successful companies do, right? So I think that there is not an easy path to that. I think that growth is very important. Every day growth is very important. But in order to generate cash flow, we have to measure all that all the time.
So I think what we are presenting here is a plan that has considered both, and we are going to grow both at the level that we are talking here. But essentially, this is probably the most difficult thing in this market, right? So I think to do this right is the key success factor.
Yeah. The only thing I'd add to that is there's a reason, Tom, that we're not talking about taking out free cash flow conversion back all the way up to perhaps where CSL is at the moment, right? So we understand that tension. We're working within the limitations of that tension. But at the same time, we feel pretty good about being able to achieve this. And as you say, there's a push and pull in terms of when you push one and pull the other.
I believe we've got the right sort of balance and the right levers in our toolkit to manage that.
Cool. That's very clear. Then my second question was just on HEMO and Biotest, the BPC, the plasma bit. You noted in your presentation you intend to exercise option 26, 27. To what extent is that tied to the timing of your refinancing of your 2027 debt? Because obviously, you're not going to refinance in Q4 2027. You'll probably do it at some point before. So is it really going to do it before or after, or is that not part of it?
Actually, if you go to that slide, anyway, it has nothing to do with the refinancing. Why?
Because my intention is to try and, as part of our disciplined approach from a capital allocation standpoint and so on, and disciplined approach from capital structure, my intention is to finance that through free cash flow generation and continue our deleveraging path. So it has nothing to do at all with our refinancing plans, which is why whether it's 2026 or 2027, we will do it when the time is right, when the conditions are right. And again, it's an evergreen option in much respect. There's no gun to our head, but it feels like the right thing to do in order to try and move forward given the topic as a whole from a just a corporate.
May I just ask the same question a slightly different way then?
In your mind, what is the sort of higher priority, resuming capital returns to shareholders or executing the option on HEMO and BPC?
Look, at the end of the day, we're managing multiple stakeholders, right? We've got a large debt complex. We've got an underserved equity complex on the basis that we've not paid any dividends out for the last five years and showed a huge amount of prudence and good custodians of the balance sheet. We'll manage all of those stakeholders in a sensible way without in any way pushing one over the other, right? So I think in my mind, there is an opportunity to do all of it and do it in a sensible way, do it prudently. And I believe we've got a plan to be able to do that.
That's very clear.
Thank you, James. Thank you, Tom.
We have a question on the fifth row, please.
Thank you. Yes, Justin Smith from Bernstein. Sorry if this is a slightly ignorant question for Roland. Just on the Xembify CIDP launch, just if you could explain it. It seems like that's taking quite a long time, or if I've missed the point, I'd love to understand that. Yeah, thank you.
In the US, we will have to run a trial in CIDP. We're actually actively working to see how we optimize that. And we will be sharing more information when we do the submission correspondingly.
So that's got nothing to do, for example, with patients being taken up on the FRCNs, for example. It's just a blocking and tackling with the FDA, is that right?
Yeah. Yeah, yeah. That's absolutely. No, no. We see a runway here, and it's just sequentially adding the indication for our sub-Q. Yeah.
Nothing to do.
Okay. Thank you so much. The guy on the fourth row. Thanks.
Hi there. Good afternoon. Himigi from HBK. Just to follow up on BPC and Haema, please, if I may. Could you give us an update on what the strike price is there? Is it still the, I think, circa 500 that was initially announced, or has it developed since then? And if so, how should we be thinking about it? Thank you.
Yeah. Look, I mean, there's quite a lot of disclosure around the purchase options and so on within our notes. I'm trying to quickly look at where in the notes it is. I believe it's in Note 19, if I'm not mistaken. And so nothing's changed in that regard. So look, we will continue to monitor and proceed when the time and when the conditions are right.
It is in, I'd like to believe, in our control, right, in terms of when we press that. And we feel pretty good about where we're at, right? So the 26– 27 guidance, I think, is a sensible one in terms of how you guys should think about it.
Okay. Thank you. You, please.
Hi. Mike Denebrown from Redburn Atlantic. Just two questions. First is, are you considering the remaining 6% stake in Shanghai RAAS as a way to finance the call or the call optional Biotest stakeout? That's the first one.
I can take the 6% stake in Shanghai RAAS. I think China is a significantly important market for us. I think that the potential use of immunoglobulins and albumin in China is very relevant today, and it will be very relevant in the future. And we feel good having a partner there.
I mean, we've seen how many other multinational companies are going to market in China, and it's difficult to go to market in China without a solid partnership there. And I think that 6% provides that access to Shanghai RAAS and to Haier, which is now the control entity of Shanghai RAAS. So I think that this 6% is something that we would like to keep in the portfolio because it provides that strategic access to a very relevant market in China.
A nd yeah, and again, on totally unrelated points. One is, as Nacho has already picked up, and the other one is we will generate free cash flow generation. One of the reasons why I've gone out and provided guidance around leverage at the end of 2027 is to take the issue off the table that we're not going to go on some releveraging spree, right?
So in our minds, we've got a number of options. We're in a decent liquidity position for the moment. We expect to continue generating cash flow. So we'll use whichever lever as we see fit. But continuing to do, continuing on that deleveraging path while cleaning up certain aspects from a corporate simplification just feels like the sensible thing to do now that we're in a position to do that.
Understood. Thank you. And then the second question is, maybe you can just touch on the strategic rationale of keeping a 55% stake in GDS, and why not consider that for disposal?
I think I have elaborated that in the presentation, but there are a number of reasons, some pure financial reasons. I mean, GDS is a highly profitable business with a free cash flow conversion from EBITDA of about 90%. That's very welcome in our mix, and we welcome that.
And then it's synergistic with some of the biopharma activities that we are running. So when you put these two things together and you pair that with the fact that we have a strategic plan for diagnostics, which is very solid, with three platforms, three very relevant platforms that all of them are launching very quickly, and they are significantly ahead in the development process, it makes us quite confident about the future of diagnostics. So when you put all these things in the mix, we clearly believe that diagnostics and this 55%, it makes sense to continue within the group.
Okay. Before moving that, I will take a question from Graham from Bank of America. He's asking about the Inflation Reduction Act and why it's so broad the range that we are providing in 2025, and if there is any mitigation for 2026 and beyond.
For 2025, as Nacho explained, I think one thing for us to keep in mind in our specific case is that our medicines can be covered in the U.S. in two different ways. One is through drug benefit, Part B, or the other one is through medical benefit, Part B. Where patients go depends on the patient coverage, the payer direction, where the patient itself goes. So we expect that there may be a change in the course of this year. That's why we felt more comfortable with the range. I think when we think beyond, we are aware and are happy to see that there's legislation being discussed on the Hill, which is looking to exclude plasma-derived therapies, not only or have a phase-in for plasma-derived therapies, not only the first two parts of the IRA, but also in the IRA Part D redesign.
We have to see how this continues, but yes, so for 2026 and beyond, there's discussions of whether there can be a relief for plasma-derived therapies. We will see.
Okay. Very clear, Roland. The second question from Graham is about the margin expansion. What part is going to be gross margin? What part is going to be OpEx?
Again, I would say a large part of the margin expansion is coming from gross margin improvement. OpEx, we're in a reasonable spot. Even if we do try and drive that, and there are opportunities to drive that tighter, we also have talked about invigorating our R&D and digitization initiatives and so on. So as I look at all of that, I would say I think a fair assumption is a large part of that will come from gross margin.
Okay.
Donnie, if I just may, yes, I was mentioning the plasma initiative on the Hill. Just for clarity, in our numbers, we assume IRA to stay.
Oh, 100%. 100%.
So these are more to follow, but our case includes IRA.
IRA is absolutely embedded in all our numbers going forward, right? So this isn't something that you're going to get an update every year because that's the new standard, and it's in our numbers. That's just the new world order, and that's fine.
Okay. Sure. Very clear. Joe, please. This lady.
Jo Walton, UBS. I'm afraid I'm returning to two things that we've been discussing already. So just on IRA, could you tell us what proportion of people at the moment use Part B and Part D?
And whether you have considered that with a sort of all-you-can-eat buffet for $2,000, if you're a Part D patient, there may be a switch from Part B to Part D. And if that happened, would that make a difference? And are you assuming any increase in volume? Because patients can now, again, consume more, so maybe you get greater persistence. So I'm just asking for a little bit more of your assumptions behind how you get to that IRA number.
No, and you touched on some of the very interesting questions that will come of how care and stream of patients could evolve this year. And things that we all discussed and looked at, the $2,000, the lower out-of-pocket for patient, that's a great thing if you're a patient. We understand that for some patients, that has really been a hurdle to treatment.
Yes, we hope that this will help more patients in our indications actually get access. The interesting part when it comes to shifting, one part to keep in mind is, yes, manufacturers have to contribute more, but payers have to contribute much, much more in Part D. So the lion's share of the catastrophic phase cost is to be borne by payers. So the government shifted the majority to payers and a smaller part to manufacturers. So it will be interesting how payers would react if there would be a run towards more Part D. So we'll have to see how this evolves. At the moment, we feel that our range is a sensible one, and it's based on the number of patients that we've been seeing in the CMS data in the 2022, 2023 range.
Okay.
And my second question then, we've seen you expect strong growth and margins. Now, if we spoke to any of the big three players, we'd all hear a similarly rosy assumption about growth going forwards. Now, normally, when companies all do very well, one of you breaks ranks and starts to gain market share, cut prices, or something like that, and not everyone is a winner. Can I ask each of you to tell me one thing that you think that Grifols does better than one of your competitors that's going to put you in a good stead going forwards? Is it the fact that you've got a more geographical range of donors, which will ultimately prove to be excellent, or you've got lower cost per liter in fractionation because of some technology? I'm just looking at how you benchmark yourself.
So if each of you can give one example of why you're the best.
I'll go first. Not why we're the best. Why we're the best proposition at this point in time. None of that. None of that can offer you a 35% free cash flow growth, Kager. We can. That's mine, Don. Go ahead, Nacho. You're up next.
Well, that's a pretty detailed one. I think that, and it's a good one, by the way. I think you mentioned some of it, right? So I believe that our diversified footprint in terms of donor centers, collection of plasma and manufacturing, especially in the current world where there is a lot of things going on, and I think that flexibility and adaptability is going to be a key factor for success.
I think we are well diversified, and we a re present in many places that we will be able to handle whatever the world will bring to us in an easier way than others.
You may have more people than anywhere else, though, if you've got that degree of flexibility.
Just to round it off, closer to the patient and physician, what we see is that the brands that we provide are highly appreciated by prescribers and patients, and we do see that we have an opportunity to not only talk about price, but also the value that we bring as a company. And I think that's what excites us to get with innovation that we can drive, so from the financial proposition to diversification, as we look at the whole enterprise, to the impact that we can have for patients and for prescribers, I think we're in a good place.
Thank you.
And the most beautiful thing of all is that we are in an industry where more and more patients are being diagnosed, that is growing nicely. And that's something that will benefit us and will benefit our competitors as well.
Okay. Thank you, Joe. Tibo, please. Morgan Stanley.
Thank you. Tibo Gutman, Morgan Stanley. Just my first question is just to follow up on Alpha-1, specifically within your midterm guidance, if you could tell us what you assume in terms of potential entry of recombinant therapy. So is it fully absent from the guidance? Is it probability adjusted? Is it within the range? So if you could maybe comment on this first question.
Probability adjusted, right? I mean, I think at the end of the day, and Roland can speak to this better than me, there is also a significant amount of unmet demand there.
With us being the clear leader, we'll see how this evolves. Like I said, we're not swinging for the fences in terms of our assumptions on Alpha-1. As you know, there are some aspects in the Alpha-1 performance that perhaps held us back as well, which we intend to address in the coming quarter. I would say probability adjusted, relatively balanced in terms of our approach. Upside to it, yeah, sure. There's perhaps downside to it as well. Roland, I don't know if you want to pick that up.
The product has not been launched, right? First of all, it needs to be launched. They need to finish the clinical work. They need to prove all what they want to prove, and then they need to launch the product.
And so I think we are including in our model some potential impact, but most importantly, we are including what we are doing to try to mitigate that impact, whatever will happen, right? So I think we have a realistic approach to Alpha-1, but also we're going to fight it, right? So we're going to present a good fight to keep that franchise, which we have a very high market share.
Thank you.
And if you ask about the 29 number, I think balance is a good approach to it because absolutely there's upside in so many patients to be diagnosed. With our outcomes drive, we believe we can do that. We realize there may be new entrants, and so between the two of them, we've taken a balanced approach.
Thank you very much. And just the second question is on the dividend.
Do you already know at this stage the timing of the first payments? Is it still open? And if you could comment on your general expected dividend policy as well.
Yeah, no, happy to. As I know, it's been a while since we paid a dividend because we've been good custodians of the balance sheet and been hit by a once-in-a-100-year pandemic, and we're coming through and coming out of that. And going back to the pandemic, for those unfamiliar, we've always approached dividends by paying an interim dividend, paying a final dividend. We could approach and do it in a similar way this year. So that's your first question. Second question is there's no change to our existing dividend policy. That remains the same. Prior to the pandemic, it was up to 40%. That's something that we will work through as we think about capital allocation and so on.
So again, go back to the point that I made earlier on. There are a number of stakeholders here. We feel pretty good about where we are, feel very good about the outlook, and we'll manage all these very stakeholders in a very prudent way and a prudent and risk-managed way going forward.
Okay. Thank you. Before taking one, I'm going to take this lady, please.
Hello, thank you. It's Danielle Ward from JP Morgan. A couple of questions on the debt side, if I could. You mentioned the target to get back to double B, strong double B ratings. What timeframe do you have in mind for that? And on the refinancing optimization that you talked about, you mentioned the secured debt capacity. How do you envisage your capital structure looking in the medium term?
Do you see it being an all-secured structure, or will you be flexible based on market conditions, etc., from here to 2026 or so when you may be thinking about it more seriously?
Sure. No, happy to. Look, I mean, stuff like ratings is not in our control, right? We control strategy. We control financial performance. We keep our heads down and just execute on that. And I think we expect the re-rating story to continue in the coming quarters and years. Your question around timing of when exactly will be double B plus. I'm not going to stick my neck out and try and work out when the agencies will do what we think is sort of appropriate. All you have to do is go back in time and look at how they've approached leverage and where we were at that point in time.
Just as an example, if I'm not mistaken, we were at double B- plus around the time of the pandemic when our leverage was in the mid-fours. Will we be allowed to go back there given that we're at two or three notches below that? Look, we're kind of playing with, I think, the rating agencies. To be fair to them as well, they are also working through how they approach re-ratings for companies that are coming back out of the pandemic. So again, I'm not going to preempt that, but we feel pretty good about the direction of travel. The re-rating process has already started, as you've seen with the rating agencies, and I expect that will continue. Your second question was just around my expectation around capital structure and capital structure strategy. Look, everything's open. We don't have to make any strong decisions right now.
Do I like the idea strategically of having secured capacity? Sure, I love it. Absolutely love it. Today, I have almost two tons of secured capacity. Do I love the idea of long-term unsecured debt at very reasonably priced? Yeah, I like that too. But at the end of the day, we're going to have to make choices and optimize our capital structure based on the conditions of the time. But what I do feel incredibly positive and strong and confident about is dealing with our balance sheet, not because I ran leveraged finance at Bank of America for a long time, but I feel pretty good about where we are capital structure-wise.
Okay. Thank you so much. Juan Ross from Oddo, please.
Thank you. I'm Juan Ross from Oddo BHF. My first question is regarding your 2025 guidance.
I don't know if maybe you can give us a rough estimate of what would be the, as reported, EBITDA and free cash flow figures now once we deduct the IRA, we deduct these non-recurring items that you're planning to have.
So that'll be the question. So I think your question is, what would be the impact? Is your question, what would be the impact of pre and post IRA? Was that your question?
No, no, no, just pre and post IRA. So your guidance, you've provided a guidance for fiscal year 2025. That's inclusive of
post IRA.
Post IRA, is there going to be what I'm trying to do is to bridge the adjusted EBITDA with the as reported EBITDA that you're going to have.
Yeah, okay. I understand your question.
The as reported EBITDA.
I understand. I understand your question.
So your question is, first of all, let me add one point I make. The 2025 post IRA guidance, that's the guidance, right? That's what we're talking about. The reason we showed pre IRA was just to show, explain the bridge in terms of what this IRA impact will be, right? So that's number one. Number two, your question around adjusted to reported EBITDA. What I also said before was that our expectation is to continue to see greater convergence between adjusted EBITDA and reported EBITDA, just to give you guys some context. In 2023, the adjustments were 228 million, if I recall correctly. I think that narrowed down by a third roughly to about 140, give or take, this year. And our expectation is to continue that convergence further. And I think that's as far as I will go at the moment.
And particularly, as we think about that convergence, the focus really here is cash adjustments between reported and adjusted EBITDA. So to answer your question, it's going to be less than this year. I haven't gone as far as telling you how much less than this year, but it is a key focus for us as we continue to get those two EBITDAs converged.
Thank you. My second question is regarding potential disposals. You already said the 6% you have in RAAS in Shanghai, and so does the 55% you have in DDS. You're completely discarding any other disposal, or is there any asset in your portfolio that you might consider selling if there's an appropriate offer for that asset?
Look, the short answer is no and yes, right? So I think that at the right price, everything is to be considered, right?
But the right price needs to be an elevated price, essentially, because in our strategy, we don't need to dispose of any other asset. I think that what we have outlined today is that the company will generate sufficient cash flow and will generate sufficient profit over the next years as it is with the current perimeter, right? And because of that, all assets which are around us and that they are producing certain accretion to the company, right? So they are welcome. Having said that, I think that we have assets. We have different options. You never know what can happen, what someone can offer, what can put on the table. But this is not in our strategic plan at this point. Thank you.
Okay. Before Álvaro, Marcos, please, from Caixa.
Yes, hello.
My first question is for us that some of us have been following the company for many years. There has been a process by which the company was more family-owned and managed, and now it's becoming professional. So the question is, it's dual. Is this process completed already with the new board and the new management and the new kind of changes that you announced in the past year? So are we clear about this conflict of interest forever? First question. Or related to that, can you help us to explain what happened last year with the bid of the company? Because EUR 10 per share, if I take EUR 3 billion or EUR 2.9 billion 2030 and apply the average EBITDA since the company was listed, which is 16.3 times that I checked, you already go to a market cap or an EV of EUR 45 billion.
You deduct the debt, and you get to a market value of, yeah. It's like, and the market cap now is EUR 6–EUR 7 billion, and the offer was EUR 8 billion maybe. So a lot of numbers, but the question is, can you help us to understand what happened last year with this bid and why the family was there? Maybe there is some explanation to that. Thanks.
Yeah. I mean, two questions, and I'll answer first the first one, right? So first of all, I would say that we are no more professional than the previous management was. So the previous management was part of the family, but they're still professional people, right? So I think that, I guess, you referred to more separating ownership from management, and this is where we are here, right, and this is a process that started well before I came into the company.
I came to the company precisely because that process started. It has been a well-orchestrated process where the board and obviously part of the board, we have some members in the board which are members of the shareholder, the Grifols family, they decided that they wanted that path for, I guess, the good reasons of how to be a well-established, well-understood, publicly traded company with an independent activity and taking care of all the shareholders, right? Not a specific one. I think this was a decision that was taken probably two or three years ago and has been taking some time to be implemented step by step smoothly. I think that the short answer is yes, it has been completed. It was completed. I think that the last two members of the family, Raimon and Victor, they welcomed me when I joined in April.
They stayed, as agreed, a couple of months with me. They were incredibly helpful in order to transition the responsibilities to me, and they left. And since then, they have not been in the office. They are not part of that. Of course, they continue being a relevant shareholder, and they continue being in the board, and they continue being contributing. I mean, they have a significant wealth of knowledge about that business, and I really welcome their views, their feedback, their opinions, and their contributions in the board alongside with the all other independent directors that now we have in our board. And I would say probably the key point that will explain well that this transition has ended and has ended for good was precisely the potential takeover that we had in the middle of last year.
I think that the independent directors that were the only members of the transaction committee evaluating the transaction in an absolutely independent way and taking care of the interests of all the shareholders, they really stand up for the company. This was really a significant milestone as well in that change in governance. Now the recent change on top of that, I think that we have a number of new faces in the board. Yesterday, we announced, or two days ago, we announced a new chair, chairwoman in this case, Anne-Catherine Berner, again, coming three months ago from the company, no ties to the family and completely independent. Now it's going to be the chairwoman. So I think that, and from a management point of view, I can tell you that we can execute.
We have a board that helps us, supports us, gives us direction as they should do, but we are completely independent in the execution of our strategies, right? So I think that hopefully answered the first question. As for the second question, it's not to me to answer that question because I don't know. I cannot say what was in the decision or why Brookfield took the decision that they took. I can tell you that I personally think that in the process, in the due diligence process, we presented a good company, a solid company. We've had significant performance over time. I would say they like it what they saw. That's what I would say. I think they like it a lot what they saw. What are the details about what led them to make the offer they made and the discussions with the transaction committee?
I was not involved, as it should be. I was not involved on that. I know the results, and I would agree with your comments about the valuation of the company as well, right? So I think that's quite common sense. So I cannot answer specifically what happened there, but I think most importantly, we are where we are today. You know this Capital Markets Day. My original plan when I joined the company was to have this done a few months ahead, a few months in advance. I'm very happy that we are doing here because, I mean, honestly, I believe Grifols has a phenomenal story to tell, a phenomenal story behind us, a phenomenal story in front of us, and we wanted to come and share, share with the markets and share with our investors.
From here, focusing on execution and delivering and keep building value for everybody.
Thanks a lot. Just if I may squeeze a little one, you both are relatively new to the company, one year or a couple of years in total. Have you found the systems, IT systems, control systems, CRMs, all the systems because the company is quite global. It's spread all over the world. I mean, the systems are up to date or you need to do an exercise for the next few years?
There is always work to do. I would say, I mean, the company really operates as a global enterprise, and I think actually from a numbers point of view, I think, for example, our ERP is really very strongly consolidated, so we have a strong control from that. That's a significant component of all the controls.
This is something which is already there. I found it already there. There are other areas that obviously you always need to tweak and improve, but I think it's something that we have in the radar. We will make some investments in IT and digital transformation moving forward, but really more oriented to really extract more from them than really an expense, right? So I think it's good. We have a new chief digital and information officer that joined the company a couple of months ago, and now we are building that plan. So there are no extreme urgencies. There is work to be done, as in every other company. But I think the fundamentals were there.
Okay.
Thank you, Marcos. Álvaro, please. And then Jaime.
Hi. Álvaro Valencia from Alantra Equities. Thanks for taking my questions.
The first one would be, if I look back since before the pandemic to now, I see your competitors have outgrown you in terms of IG. So I was wondering what can change for you to maybe regain the market share loss? Maybe if you could explain what the main reasons have been for the share loss and if you think your current portfolio of products, maybe with the addition of Yimmugo, can help turn that situation around and if that is embedded already in your guidance.
I can tell you about 2024. As I said, in 2024, we know well that we have outgrown the market in the United States where we had lost market share in years prior, right? So I think that this was very much related to the post-COVID implications in terms of inventory levels, etc.
We have started since the beginning of this year, we have started the recovery of that and already very influential. This is the U.S. Outside of the U.S., we have a phenomenal year. I mean, we have a phenomenal year of growth. We clearly grew more than competition pretty much in all jurisdictions. Again, I think that we will continue with those tactics that have been working very well. I don't know, Roland, if you would.
No, and I think both of these possibly have some roots in the pandemic where you're right. In the U.S., we lost share during the pandemic, and there was a plan put in place at the end of 2023 to see that we can actually regain patients. We're very happy with the momentum that we saw throughout 2024.
We strengthened the team, restructured the team, and put more focus on our commercial capabilities in the U.S. But vice versa, what we saw is that we're really well-positioned ex-U.S. after the pandemic, and I think that's where we were able to benefit, we believe, from a lot of the recovery momentum that we saw globally translating into results that you saw.
And by the way, I think that this is testimony of something that Grifols during the pandemic times, many companies really focused the limited supply that was available in the United States for obvious reasons. I think Grifols took the stance, which from an ethical point of view, I think is highly valuable, to really the supply that was existing to really share among different geographies in order to make sure that all the patients would have access to some minimum levels.
These activities are now, in a certain way, being appreciated by many public governments in terms of considering the efforts that were done by Grifols at that time. And that's what is allowing us for a massive growth in 2024 and hopefully beyond.
Okay. And second, I see that Albumin was not part of your sort of innovation R&D part of the presentation. So I don't know if you have scrapped that all those projects for cirrhosis and other hepatic indications.
No, what we can say is Albumin, of course, plays a very important role in clinical care and medical care, and we see Albumin continuing to increase in its usage. There are still parts of the world that are looking for more Albumin. I think the part is, as we look at our strategy, our main core driver is IG growth.
That's where we invest, and that's where we, with our yield improvements, we will see that out of a liter of plasma that we collect, we can actually produce more medicine. That's why you see IG growth higher. For Albumin, our strategy is just the Albumin that we produce; let's see if it gets to patients. That strategy is relatively simple. We focus on the high-value markets. We're in a very strong position in China. Through our alliance, we're well-positioned in the U.S., and then we just look externally. But our aim there is really to balance a liter. That is relatively simple and straightforward. That's why we didn't put it at a separate section, but it's the second pillar that you saw on that slide that had IG growth to grow, Albumin to balance, and then leading with specialty and new products.
The Albumin part is the second pillar there.
And last, if I may, on the leverage target, I see that you are still maintaining the covenant-grade agreement. You know that most rating agencies don't use that definition. Possibly when the refinancing comes due, probably those terms will not be sustained. So I don't know if we look at the more generally accepted accounting principles sort of measure of leverage, that would imply that you still look at four times leverage to EBITDA. I mean, just looking long term, whether it's.
Sure. Let me address the question. First of all, the credit agreement adjusted leverage that we have, I mean, we are one of the largest leveraged finance issuers in the market. And if you believe that we have the most forward-leaning definition in our credit agreement, that's far from true. Far, far, far from true. Okay? Number one.
Number two, rating agencies, we've not changed the way we've approached credit agreement leverage even pre the pandemic, right? So when I talked about four, four and a half times before, it was the same. It was based on the same credit agreement leverage. So the rating agencies approached their metrics in whatever way, and we were a strong double B back then, even at or around current leverage levels. So again, I'm not at all. I let the rating agencies do what they do, and I respect them very much. Your question was around, do we intend to keep? Listen, at the end of the day, it's a basis. And one of the things that I want, what we're trying to transmit is consistency in the way people track us, right? From just a deal, from a leverage and a deleveraging standpoint. And we've had the standard way of sticking to it.
From your question around, so today, I think you're making the point that if you don't assume adjustments between adjusted EBITDA and reported EBITDA, then our leverage would be higher. Okay. But as I said earlier, adjusted EBITDA to reported EBITDA, I'm converting it. I say, "I. We are converting it within six to nine months." So it's not some, "I will in three years' time get to that adjusted." It's happening much quicker. So it's not as forward-leaning as people say or I've seen a report that reflects it. So that's number one. And then certainly the other aspect of it is the leases aspect of it. So our expectation over the period of the strategic plan is for the two to narrow significantly more. And I think by the end of 2029, in fact, the difference between adjusted leverage and reported leverage is less than half a turn.
That's like a quarter of a turn, quarter or slightly more than that. So it narrows quite significantly. And one that at some point we'll look at trying to make sure we align both the equities and the leverage world. But far from being an aggressive view in terms of leverage. In fact, one of the least aggressive credit agreements that I would say were still dated going back almost 10 years in terms of the formulations we have. So again, I'll leave it at that.
Thank you.
Okay. Thank you, Rahul. Thank you, Álvaro. We're getting close to the hour. I don't know if there is any other room from Frank.
Yeah, over here.
Frank is right there. Yeah.
Thank you. I have a question on the use of AI that you mentioned during your presentation.
Obviously, healthcare is a very well-recognized use case for AI for treatment and drug design for disease prevention. Is that something that you're going to do alone? Are you going to partner with an AI company who has built a model? How do you, in the end, take advantage of the fact that you own what's really valuable, which is all this data that you've harvested for decades now?
I think it's, yeah, two parts. One is the Kronos part AI, and then the other one is perhaps the patient identification. If you want to take the first one.
Look, AI, at the end of the day, is a set of tools that you need to use how to use it, and there are companies out there that know how to use it much better than any pharma company in the world.
So I think that for me, we need to be aware of those tools. We need to be aware of what is the potential, and we need to identify how can we use that to advance our business agenda. Once we do that and we know the specific needs, is that we will partner with someone that can help us to make it happen, right? So to try to, we are not Google, and we don't want to be Google, right? So I think we are who we are, and we will partner with whoever we need to when we identify that opportunity.
And perhaps one thing to add, I mentioned AI when it comes to patient identification for Alpha-1, but we're the same in CIDP. And what we see is that leading universities in the U.S. are interested in making better use from their records.
So it's them wanting to apply AI. So that's even a part where we provide the support, the expertise from a clinical perspective, but we see that there's a number of IDNs that want to use their tools to better identify patients, which is great because the diseases that we treat are still underdiagnosed and undertreated.
Okay. Thank you so much. Jaime, you are back. Your turn.
Sorry, family commitments. Yeah, two questions from my side. The first one regarding GIC 8% debt. I don't remember very well, but I'm not sure if in 2026 there is a window to repay that. Any plan that we can get this out of the way since it's the most expensive debt, and how could you tackle that? And the other question is regarding this slide regarding Biotest. You said full integration of Biotest is the plan.
Does it mean to buy in the minorities or not necessarily?
Yeah, let me take both those questions. On GIC, it is 8%, but it is also a 2036 maturity, right? So you've got to balance that out, and the good news is that's unsecured. That's unsecured debt going out to 2036. So I feel pretty good about where that piece of debt is in terms of where we are as a capital structure today, right? But sure, I talked about levers that we can pull in terms of optimizing. That could be one lever that we could pull at the right time to optimize, certainly before the end of 2029. But remains to be seen. There is no rush for us to decide one way or the other. So that's on GIC. On Biotest, we have options. It's as simple as that. We have options.
We're going to be disciplined. If the time and conditions are right, we will progress. And I think whatever we do is going to be based on just a very well-thought-through plan and ensure that it works for us, right? We've done a number of things already that allows us access to those proteins. But again, depending on time and conditions, we will progress that file. And if executed, as I said on that page, it will be financed through free cash flow generation whilst continuing our deleveraging profile.
And one final question, if I may, regarding the 7% CAGR growth, can you kind of quantify how much does it come from new products or give us some sort of big sales on the most relevant ones? I'm building on this. I remember in the last Capital Markets Day, the leukemia trial was meant to be like a big opportunity.
I don't know if it was a one billion market cap opportunity. Maybe can you update us on that trial and the opportunity?
Thank you. Yeah, I think, Rahul, you gave quite detailed guidance when it came to the different growth drivers across the portfolio. On the IG side with the high single digit, I don't know whether you want to summarize it from your side just to stay consistent.
Yeah, look, at this stage, Jaime, I think the guidance that I provided before, frankly, stands. I don't want to go product by product. I just don't think that's appropriate in this forum. But look, again, as I look at the portfolio as a whole, I think it's a very balanced, risk-adjusted approach that we feel pretty good about. I think that's where I'd like to leave it, Jaime, if that's okay.
Okay. Thank you so much.
Any very last question? No? Okay. So thank you so much. With that.
Well, thank you. Thank you all. It's been very intense, three hours and a half, and you all have behaved very well, I have to say. There's a lot of information from our side. So now it's time to relax a little bit. The entire management team is going to be there. We are happy to continue the conversation and chatting. But really, thank you for the time. Thank you for making it over here or for the people which has attended virtually. I hope we have done a decent job explaining our story for the next years. And from here, I can assure you that this team is going to just turn into execution mode and delivering on what we have been promised today. So thank you very much, and I'll see you in the next room.