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Grifols Sa Barc Ord New
11/6/2025
Hello everyone, my name is Dani Segara and I serve as a Head of Investor Relations and Sustainability and Vice President at Grifols. Welcome to our review of the company's business results for the third quarter of 2025. Today I'm joined by Grifols' Chief Executive Officer, Nat Chavia, the President of Biopharma, Roland Vandeler, and Grifols' Chief Financial Officer, Rahul Isrinivasan. A few logistics before we get into the details. Today's call will last about an hour, including a Q&A session. As a reminder, this call is being recorded. You can find additional materials, including today's presentation, in the investor relations section of the Grifols website at grifols.com. The transcript and a reply of the webcast will also be available on the investor relations website within 24 hours. Turning to slide two, please note that this presentation includes forward-looking statements regarding, among other things, the company's future operating and financial performance, market position, and business strategy. These statements are based on current expectations and available information as of the date of the recording. They are subject to certain risks and uncertainties that may cause actual results to differ materially from those projected. Grifols financial statements are prepared in accordance with EU IFRS and other applicable reporting provisions, including Alternative Performance Measures, or APMs, prepared under the Group Financial Reporting as defined by the European Securities and Markets Authority. Grifols management uses APMs to evaluate financial performance as the basis for operational and strategic decision making. These APMs are prepared for all the time periods presented in this document. Now moving to today's agenda, and I will turn the call to Nacho to kick it off. Nacho?
Thank you, Dani, and hello everyone, and thank you for joining us. The results we are presenting today demonstrate the continued commitment to delivering on our value creation plan. The performance achieved in the first half of the year has carried through, resulting in solid operational and financial results for the third quarter. This quarter reflects the sustained underlying demand of our products, solid market dynamics, and disciplined execution. While we continue to navigate, exchange rate headwinds and the anticipated impact of the Inflation Reduction Act. This progress also stems from the operational focus on financial stewardship we established in our roadmap at the beginning of the year, which remained the central pillar of our plan. Our core business continued to perform well through the third quarter, led by the immunoglobulins franchise. This top-line performance has supported margin expansion, while tight cost management and focus on free cash flow generation have driven meaningful improvement in our free cash flow. While we acknowledge the challenges of the complex global operating environment, Grifols has performed with consistency and confidence. Our structural advantage, including a scale, solid vertical local integration in key markets, and a globally diversified footprint, have enabled us so far to adapt effectively, mitigate external pressure, and sustain solid performance across key markets. Regarding chain rate headwinds, the impact was reflected at both revenue and EBITDA levels, but it did not extend to our leveraged ratio or free cash flow due to the significant levels of natural hedges within our business. In any case, we continue to implement mitigating actions and maintain vigilant oversight of evolving external conditions. As we track toward year-end, we remain attentive and measure in our approach. Year-to-date performance has been solid and in line with our expectations. reflecting discipline, execution, and resilience. Looking ahead, we recognize that the external environment remains complex and dynamic, yet we continue to actively manage the factors within our control. By leveraging our structural strengths and maintaining discipline, we remain on track to meet our 2025 objectives. Before we move on, I want to pause and take a moment to thank the entire Grifo teams for their ongoing commitment, focus, and passion in executing our plan and advancing our mission. And with that, let's move to slide five. On a year-to-date basis, we achieved revenue of 5.5 billion euros, representing a year-over-year increase of 7.7%. and 10.5% like-for-like after IRA and gross-to-net adjustments, both at cost and currency. Third quarter adjusted EBITDA of €482 million built on a strong first half, bringing our year-to-date adjusted EBITDA to €1,358 million, up 11.2% and 17.3% like-for-like, both at cost and currency. Both figures are well ahead of revenue growth. Improved operational execution translating directly into a positive year-to-date free cash flow pre-M&A and pre-dividends of 188 million euros, marking a significant 257 million euros year-over-year improvement. This ramp-up in cash generation highlights our sustained financial discipline, keeping this as a top priority. Finally, the leveraging remains a critical financial priority too. And at the end of Q3, our leverage rate per credit agreement landed at 4.2 times, representing nearly one times improvement over the prior year. We continue to reinforce our structural foundation and this year to the results position us soundly to execute our capital allocation priorities and continue strengthening our balance sheet, ensuring we can create sustainable long-term value for all our stakeholders. As we have mentioned many times, the core tenets of our value creation plan are guided by three key levers, commercial growth, margin expansion, and pipeline execution. Starting with commercial growth, we continue to build on the existing market demand and our robust commercial capabilities to expand sales across our portfolio. This includes deepening our penetration in existing markets and expanding into new geographies. Margin expansion remains a core priority, supported by operational leverage, optimized plasma sourcing, and manufacturing efficiencies. And through pipeline execution, we continue to drive the innovations that define and sustain Griffo's leadership in plasma-derived therapies. While our diagnostic division advances its three cutting-edge platforms currently in advanced development. These levers are supported by two critical enables, our plasma supply and industrial footprint, and our innovation strategy, as highlighted on the slide. Our resilient, diversified plasma manufacturing network represents a decisive competitive advantage in the current global environment. It ensures reliable plasma supply and production capacity, allowing us to effectively meet growing global demand. Turning to innovation, I'd like to provide an update on our pipelines. We remain on track to launch fibrinogen in Europe by the end of 2025, with a planned U.S. launch in the first half of 2026. In the U.S., we are proceeding with the FDA biological license application for congenital fibrinogen deficiency, for which we expect a decision in late December as planned. For acquired fibrinogen deficiency and based on conversations with the FDA, we have decided to build additional clinical evidence before seeking regulatory approvals. This will help us well to strengthen an even more solid case to sustain the market development efforts we envision in the U.S. market for the years to come. Roland will share more details on fibrinogen shortly, but I want to mention that this decision does not affect our current capital markets day plan in any meaningful way, nor does this change our long-term strategy or the significant opportunity we see ahead. Other than fibrinogen, we are maintaining disciplined investment in R&D while advancing clinical programs across both lifecycle management and new product candidates. Key initiatives, including SPARTA and Alpha-1 with subcutaneous formulation, are progressing as planned, underscoring our commitment to sustain innovation, patient impact, and long-term value creation. And with that, I will hand this over to Roland to expand on these and other market and business updates.
Thank you, Nacho. I am pleased to share an update on our biopharma business and highlight the key factors driving our performance this year. As we continue to deliver on our value creation plan, I am proud of the dedication, the passion, and commitment our team shows every day to deliver for patients and drive forward towards the goals we set out in terms of commercial growth, margin expansion, and innovation. With that, let's turn to slide eight for our commercial performance. In the third quarter, our biopharma portfolio grew by 10.9%, lifting our year-to-date growth to 9.1%, both at constant currency. Our Immunoglobulins franchise led the way, outpacing the market with 18% growth in the quarter and 14% year-to-date, both at constant currency. This performance was driven by Gamonex and Xembify, with IVIG and SubQIG delivering 12-month growth of 13% and 62% respectively. We remain confident in Xambify's strong trajectory, supported by continued strength in the U.S. and expansion into new markets in Europe. I'll dive deeper into our IT franchise on the next slide. Turning to Aldumin, third quarter volumes remained solid, but were offset by ongoing pricing pressure in China as market demand slowed down in face of government-imposed cost controls. This resulted in a contraction of 4.5% for the quarter and 3.9% year-to-date, both at constant currency. While these dynamics were anticipated, we continued to work with our local partner Shanghai Ross on how to best manage market dynamics and sustain a strong position in China as the principal market for albumin. At the same time, we are working on strengthening our presence and unlocking additional growth opportunities in the U.S. and other markets in order to help us balance albumin with our IgG growth over time. Looking at our Alpha-1 and specialty proteins franchises, we continue to make solid progress. In the third quarter, revenues grew by 3.3%, bringing growth to 4.3% year-to-date, both at constant currency. These results reflect our continued market leadership in Alpha-1 and HyperRap. I'll share more detail on this franchise in a later slide. Now, let's turn to Immunoglobulins, or IG, as the main growth driver of our business on slide 9. Over the last two years, we saw an opportunity to use our strong IG inventory position to accelerate IG growth, build momentum in key markets, and win back market share in the U.S., We have since delivered on this plan. We have strengthened our US organization on commercial capabilities, expanded sub-QoIG penetration through Xempify, and leveraged a strong profile of Cominex as a leading IBIG to win share in strategic accounts. These actions have delivered clear results. Our IG business has posted double-digit growth over these last quarters, ahead of the market and driven by demand, as we regained share in the US and Europe, and thus reset our position in the IG market. Looking ahead, from this higher base, we now expect to grow more in-line with or slightly ahead of the market, consistent with the 6-8% CAGR range we shared as part of our evaluation plan. The fundamentals for continued growth of IgE remain strong, as key indications continue to be underdiagnosed and increasing global awareness of IgE as a treatment of choice in many conditions mean that more patients get the benefit from our medicines with a long track record of proven efficacy and safety. Looking at our three main indications, growth remains solid in primary immunodeficiency, where increased awareness and better diagnosis are expanding access to therapy. In secondary immunodeficiency, the largest growth opportunity within HIV, demand continues to rise, driven by the aging population and an increase in immune-compromised patients. And in CIDP, we are seeing continued growth albeit at a lower level after the significant step-up in diagnosis last year with the entrance of FCRNs, which has helped expand this market. CIDP is a complex neurological condition with multifactorial origins, meaning the disease can present very differently across patients. This is precisely where IG therapy stands out. With its broad and well-established range of immunomodulatory and immune-supportive modes of action, IG can address multiple disease mechanisms and improve functional outcomes across a wide range of patients. As we build on this strong foundation, innovation continues to be a cornerstone of our IG strategy. We are advancing next-generation products, new formulations, and expanded indications that strengthen our competitive position and enhance patient experience. In terms of next generation IGs, Yimuo, our novel IVIG from Biotest, has launched in the US in the fourth quarter of 2025, adding another differentiated therapy to our portfolio. Xembify continues to gain strong traction, growing more than 60% over the last 12 months, and we're expanding into new markets through 2026. In terms of lifecycle management, we are advancing new delivery formats, including Xembify and pre-filled syringes to improve convenience and adherence. In parallel, we are progressing with our studies to expand indications in the US, with CommonXC and Xembify advancing in SID and Xembify in CIDP. Together with our ongoing improvements in end-to-end IT yield and operational efficiency, which will help us expand margins, this focus on innovation will ensure that our IT franchise remains a cornerstone of sustainable and profitable growth for Griffles. Now turning to slide 10, let's take a closer look at our Alpha 1 franchise and our strategy and progress in this area. Griffles has established itself as a leader in Alpha 1, with today approximately 70% market share across both the US and ex-US. Our position is testament to Griffles' leadership in building this market, our best-in-class patient support programs, and our unique testing capabilities. Despite important progress throughout these last decades, we are today still only treating about 10 to 15% of the Alpha-1 patient population across the world, leaving a large unmet need and untapped market opportunity. Testing is the key to unlocking this potential. We have over the last years complemented traditional screening with the rollout of our point-of-care and at-home direct-to-patient screening kits. Still, we only see a part of physicians systematically test their COPD patients for AATD. We believe that we have a possibility to change this and dramatically increase the number of diagnosed patients with the readout of our outcome study SPARTA, continued advances in AI-enabled screening of electronic medical records to highlight patients at risk, as well as increasing awareness in the market for new entrants. Raising awareness and improving diagnosis remain critical levers to enhance patient outcomes and enable market growth. As a company that first-hand gets to see the continued unmet need and the difference our medicines can make for the grievous illnesses we get to treat, we always welcome innovation that raises awareness and might provide additional options for patients, especially in a condition where the vast majority remain undiagnosed and untreated. As a leader in this space, we want to meaningfully contribute to this innovation, both through our outcome study that will address important questions for the field, as well as both the subcutaneous and the long-acting treatment option in our pipeline. SPARTA is the largest efficacy study ever conducted in Alpha-1 antitrypsin deficiency and is designed to show clinical outcomes in real-life lung tissue preservation different from other studies primarily focused on pharmacokinetic endpoints. The results of this study have the potential to significantly strengthen the clinical and payer value proposition for augmentation therapy, increase testing awareness, and improve patient access in the U.S., as well as support broader reimbursement in Europe. The trial also includes a double-dose regimen, which could represent an important advancement in treatment. We expect a readout of SPARTA in the second half of 2026. In parallel, we are advancing a 15% subcutaneous formulation and a next-generation Alpha-1 therapeutic to enhance patient convenience, expand access, and continue strengthening our position in this growing market. In summary, we remain confident in the continued success of For Lasting, supported by its value proposition and proven 30-plus year track record of safety and efficacy. Turning to slide 11, innovation is at the heart of our business. Our pipeline reflects a focused and disciplined approach to advancing high-value programs that drive lifecycle management, expand indications for our existing medicines, and bring new products to market both within Plasma as well as beyond Plasma. We have already covered innovation on the way for our iG and AlphaOne franchises. Turning now to Fibrinogen, as Nacho mentioned, we have refined our go-to-market approach to maximize our long-term opportunity. In the near term, the largest opportunity for fibrinogen lies in Europe, where markets such as Germany and Austria have adopted fibrinogen concentrate as standard of care. For these markets, we are on track for our launch of this product later this year. We have received the end of procedure notice from Germany and are awaiting approval in this key market shortly to be followed by additional countries in Europe. We are confident that our differentiated product positions us well to effectively compete and gain share over time in these markets. Longer term, the largest opportunity remains in the U.S., where the use of fibrinogen today, though, is still low, and the market has a long way to go to fully embrace this more targeted approach to bleeding management as standard of care. Here, we are on track with our VLA for congenital fibrinogen deficiency, or CFD, with a BEDUFA date end of December. We expect to launch this indication in the first half of 2026. As Nacho mentioned, following conversations with the FDA and observing the slow growth of fibrinogen in the U.S. over the last year, we have decided to focus our BLA on CFD for now and use the time to further strengthen our body of evidence with U.S. patients for an SBLA for acquired fibrinogen deficiency or AFD at the later point in time. While this delays our indication for AFD in the US, this staged approach allows us to provide access to our medicines for US patients with CFD in the first half of next year, while giving more time for the market to evolve, further strengthen our position for a possibly differentiated label in AFD, and set us up for a leading position in the US over time. As Nacho noted, these updates do not affect our guidance and the long-term goals outlined during our capital markets day, nor do they change our broader development efforts and our conviction in the meaningful opportunity ahead as the standard of care continues to evolve toward concentrate-based therapies. We remain confident in the program's progress and long-term success as we continue to invest in its global rollout for the benefit of patients. Taking a step back, while we certainly look forward to the launch of fibrinogen, our pipeline reflects our focused and disciplined approach to advance innovation and create value across all our therapeutic areas. We already covered our advancements in immunology and pulmonology. In infectious diseases, our trimodulin phase 3 trial in severe, communally acquired pneumonia is progressing steadily. With its innovative polyclonal antibody profile, trimodulin has the potential to address a significant unmet need. And in ophthalmology, our ocular surface IG program for dry eye disease in phase 2 has the potential to expand use of IG into new therapeutic areas. In the earlier stages of development, our pipeline spans both plasma-based and non-plasma programs, including a next-generation GammaNex process with improved yield, recombinant therapies, and novel treatments for infectious diseases. Overall, our pipeline reflects a balanced mix of near-term launches and long-term innovation aligned with our value creation plan and reinforcing GRIFL's leadership in plasma-derived medicines aimed at driving sustainable, profitable growth for years to come. With that, I now hand it over to Rahul to provide more details on our financial performance.
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