Hello everyone, and welcome to the Grifols Q3 2023 conference call. Thank you very much for taking the time to join us today. This is Nuria Pascual, Investor Relations and Sustainability Officer. I'm joined by Thomas Glanzmann, our Executive Chairman and CEO, Víctor Grifols Deu, Chief Operating Officer, and Alfredo Arroyo, CFO. This call will last about 60 minutes. There will be a presentation of approximately 30 minutes, followed by a Q&A session. So if you want to raise a question, press star followed by 5 when the Q&A session begins, and we will kindly ask you to limit your questions to a maximum of two. As a reminder, this call is being recorded, and the materials for the call are on the Investor Relations website at Grifols.com.
The transcript and webcast replay of the call will also be available on the Investor Relations website within 24 hours after the end of the conference call. Now, if we turn to slide 2. Before we start, I would like to draw your attention to the forward-looking statements disclaimer in this slide deck of the release. Forward-looking statements on the call are subject to substantial risk and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements. Now, I would like to turn the call over to Thomas Glanzmann.
Thank you, Nuria. Good afternoon and morning to all on the call. Thank you for joining us today. As you can see from our press release issued this morning, we have reported another strong quarter, further accelerating growth, improving our EBITDA, and meeting our commitments. But before we go into our operational performance, I want to address upfront what is and has been the market's concern about our deleveraging progress. Our commitment to deliver a material deleveraging transaction in 2023 of at least 1.5 billion in cash has not changed, nor has our very focused efforts to reach a leverage ratio of four times by 2024. We continue to give full priority to this.
Regarding the in June announced transaction in China, we are progressing and working diligently towards getting the agreement signed and expect to announce it before year-end 2023, in line with our commitment. As we are dealing with a very highly regulated environment, we expect to get all approvals and closing the transaction during the H1 of 2024. Ultimately, this will support the organic results we are currently already delivering to continue deleveraging the company. Let me now walk you through how we are meeting our other commitments. Q3 was another quarter of strong revenue growth, where we also delivered a 25.1% adjusted EBITDA margin, which is a significant improvement of 480 basis points compared to Q4 2022 margin.
The revenue growth was primarily driven by Biopharma and our flagship franchises, Immunoglobulin and Albumin, and we expect that momentum to continue throughout the year. All the measures to achieve the EUR 450 million cash cost savings from our Operational Improvement Plan have been successfully executed. We are already seeing and will continue to see the related margin expansion throughout Q4 and next year. This is particularly visible in Plasma, with cost per liter further declining, while our Plasma supply levels continue to grow at a double-digit pace. As a result, we are now committing to the top of our adjusted EBITDA guidance to deliver EUR 1.450 million for the full year 2023.
Annualizing the Operational Improvement Plan's total savings, our adjusted EBITDA margin is anticipated to increase to 28-29%, which is in line with 2019 EBITDA margins. Our EBITDA and cash flow improvement are significantly contributing in our organic deleveraging progress, with our leverage ratio now at 6.7 versus a peak of nine times last year. As mentioned, and I strongly reiterate, we will continue to lower this ratio and are very focused on meeting our 4 time target, including signing one deleveraging transaction this year.
And last, but maybe most importantly, we are now stepping up our focus on our growth strategy to ensure the creation of sustainable, long-term shareholder value. We are actively accelerating a series of strategic levers to strengthen our industry leadership as a global market maker, of which our recent Egypt and Canada projects are strong examples.
We have also taken steps to further strengthen the leadership team to drive innovation and digitalization at Grifols by appointing Jörg Schüttrumpf as our Chief Scientific Innovation Officer and Miguel Louzan as our Chief Digital Information Officer. Both bring a wealth of experience and have a clear compass to take Grifols to the next level. We clearly continue to see innovation as a critical strategic value-creating lever for future growth, and are therefore working towards accelerating our pipeline.
A testament thereof is that all our milestones set for the H2 of the year are on track, and having completed the Biotest Fibrinogen trial in Q3, we are confident that we will also there be able to provide top-line results soon. Needless to say, we continue to be very optimistic and excited about both Fibrinogen and Trimodulin, and the great opportunity they represent for Grifols in the future. Having delivered on all our priorities and with our fundamentals strong, we are now well on the way to truly reposition Grifols for sustainable, profitable future growth. This is a new chapter for Grifols, and we are very excited to embark on it. With that, I will now hand over to Víctor to take you through the details of our business unit's performance in the quarter.
Thank you, Thomas. Good afternoon or good morning, everyone, and thank you for joining us today. Now turning to slide six. Our revenue growth throughout the periods throughout the previous quarters has been remarkable. As we have been mentioning consistently, the sequential progression remains exceptionally strong and positive. Grifols stand-alone delivered a 9.1% growth in Q1, followed by a 6.5 in Q2 and a 9.6 in Q3, all of them at constant currency. All in all, revenues grew 8.4% for the first nine months of the year. For these first nine months of 2023, we achieved revenues of more than 4.8 billion, up by 11.7% at constant currency. This was primarily driven by performance of Biopharma in our key proteins, as well as Biotest contribution.
Please bear in mind that we are consolidating nine months of Biotest in 2023, while only five months in 2022. Now, turning to slide 7. Our Biopharma performance was remarkable, driven by growth in our immunog lobulin flagship product, which further accelerated in Q3, with 17.4% sales growth in the quarter and close to 15% year-to-date at constant currency, as well as our albumin franchise. IG continues to be driven by a strong underlying volume demand and favorable pricing, especially outside U.S. Our subcutaneous immunoglobulin Xembify continues to see a strong volume uptake, especially in Q3, backed by higher demand in the U.S. Xembify continues to offer a vast commercial opportunity, and we plan to further capitalize on this growth with launches in some European countries and Australia, starting in this quarter, in this Q4 2023.
Grifols' strategy to continue strengthening its immunoglobulin franchise in the U.S. and other selected countries is robust. We are focused on the immune deficiency market, including the highest growth primary and secondary indications, while remaining leadership in neurology and acute care. Earlier this week, we received FDA approval for a new IG purification facility, which will increase Grifols Gamunex total capacity to 60 million grams per year. This approval was not only obtained in record time, but it will enhance efficiencies in terms of yield, recovery, and cost per gram. In albumin, we achieved a strong revenue growth year to date, delivering close to 18% increase, with a higher demand in China and solid price increases in some key markets.
Alpha-1 and Specialty Proteins segment revenue was relatively flat, mainly driven by lower demand of plasma-derived factor VIII, and to a lesser extent, lower Alpha-1 volumes due to industry dynamics in some European countries. As Alpha-1 demand improves on the back of the solid underlying improvements in our successful commercial model, the current lower growth is expected to be temporarily. At the same time, I would like to highlight in this segment the good performance of our most recently launched products, such as Tavlesse, Fibrin Sealant, and Thrombin, which are growing significantly. In addition, Hypers and Antithrombin III are also delivering a positive evolution. Now turning to slide number 8. As a result of the successful execution of our operational improvement plan, cost per liter continued to reduce this quarter, declining by 22% as of September 2023 versus its July 2022 peak.
This has been driven by decreasing donor commitment compensation, plasma center network and staff rationalization, and reduction of other plasma-related costs, such as overheads. After a stabilization of donor compensation in Q2, it continued to decline slightly in Q3. Going forward, we are targeting additional operational efficiencies through process optimization, streamlined operations and overheads, lean processes, and digitalization. Plasma supply growth remains solid at 10% year to date versus last year. This Plasma supply growth positions the company to continue meeting the growing underlying demand for our products. In parallel, and since the beginning of the year our R&D, manufacturing, and quality teams have been working on a project to significantly improve our yield in gamma globulins. So far, we have seen very good results in pilot-scale production, and we are beginning to implement it in full-scale production as we speak.
In our next quarterly call, we hope to be able to provide more details of this project and its results. We expect these improvements to further improve our margins as it is fully deployed. Now, moving to slide nine. This year, and for the first time ever, the company made a strong commitment to accomplish 12 innovation milestones, and I am proud to say that we have made very good progress so far. Out of these 12, we have completed nine and are on track to achieve the remaining in the coming months. Among others, during these nine months of 2023, we have finalized the enrollment, both the PRECIOSA and SPARTA trials.
The latter, ahead of schedule, advanced from single to repeat dose, first phase in Alpha-1, a 15% subcutaneous study, and progressed in trials across our IG franchises, such as the IVIG-PEG study, the Xembify biweekly study, and the Xembify secondary immune deficiency CLL study. Worth mentioning is that in Q3, we signed a collaboration agreement with the National Cancer Institute for our GIGA-564 project, whose IND preparation has been submitted this October, which sets the stage for GigaGen's first oncology asset to enter clinical development. Also, in the GigaGen front, we have received positive feedback from the FDA in a pre-IND meeting held in September concerning the GIGA-2339 development in hepatitis B. We recently made important inroads in Alzheimer's space through our company, Araclon, on the phase II trial of its vaccine candidate, ABvac40. For this...
For the treatment of patients with mild cognitive impairment and very mild Alzheimer's disease, releasing positive final results. Regarding Biotest, Trimodulin and Fibrinogen trials are advancing as expected, and we are fully focused on capturing its strong growth opportunity. To this end, we have completed the enrollment in the Fibrinogen AdFirst trial, and are on track to publish top-line results early Q1 2024. For the Trimodulin ESCAPE trial, first patients have already been enrolled. These positive developments are a testament to our commitment to maintain and increase efforts in developing new products and indications, which we plan to continue to accelerate for the remainder of the year onwards. We expect the appointment of Jörg as Chief Scientific Innovation Officer to enable us to execute on our objectives and further accelerate our pipeline.
Now, in slide number 10, diagnostic revenues declined 3.1% at constant currency in the quarter, but 0.9% on a year-to-date basis. As mentioned in the previous quarters, our NAT technology was negatively impacted due to the pricing concessions given in exchange for extending a large contract with a key customer of ours. However, strong instrument sales in Japan and Indonesia are helping to offset part of this decline. In blood typing solutions, we are seeing a strong growth across the U.S., Argentina, and the Middle East, partially offsetting the lower sales of GelC ards experienced in China lately. In recombinant proteins, contract manufacturing from our Emeryville plant, we have signed a renewed 10-year supply agreement with an important partner in the diagnostic field. Now moving to slide 11.
In Bio Supplies, revenues declined 14.1% in the quarter due to lower cell culture sales, driven by subdued demand. We look forward to leveraging the acquisition of Access Biologicals and capturing the full potential of this business unit. I will now hand it over to Alfredo, who will go through the group's financial performance.
Thank you, Victor. Good day to everyone. Slide 13. Overall, we have delivered strong performance across the board, improving revenues, profitability, and strengthening our balance sheet. Our revenues continue to grow sustainably at 9% at constant currency in Q3, bringing the year-to-date growth to 11.7%. Our EBITDA margin continued to show sequential expansion, further improvement to 25.1% from the 23.4% in Q2. On the back of our enhanced profitability, which will continue to improve in the upcoming quarters, our leverage ratio has declined to 6.7 times from 9 times peak of last year. Organic efforts have been a key piece so far on our deleveraging path. Slide 14. Revenue has shown a very positive sequential trend throughout this year.
On last twelve months basis, total revenue has reached more than EUR 6 billion, with 11% growth. Biopharma continues to be the key growth driver, with a solid underlying demand, particularly in IG, and more notably, our SubQ IG product, which continued to gain further traction, as well as our albumin franchise in China. Our ex-U.S. strategy has been also an important growth lever, together with mid-single-digit price increases. Slide 15. Our gross margin has significantly improved over the last quarters, reaching 41% in Q3. This quarter show the steepest gross margin expansion in recent quarters, improving by 400 basis points compared to the same period of last year. This is due to Biopharma remarkable performance and a 22% decline in cost per liter, which is now clearly reflected in our P&L after a nine-month accounting lag.
On the right-hand side of this slide, you can see a significant decrease in our SG&A cost as a percentage of revenue. This reduction, which amounts to nearly 120 basis points compared to Q3 last year, is primarily attributed to operational leverage and efficiencies resulting from our EUR 450 million Operational Improvement Plan. Slide 16. All of this has culminated into higher EBITDA margin for the group, reaching the 25.1% in the Q3 and more than EUR 1.3 billion on a last twelve months basis. Year- to- date, it has reached more than EUR 1 billion and 23.2% margin, reflecting sequential improvement of 480 basis points compared to end of 2022. Most of the improvement has come from Biopharma, driven by both volume and cost per liter improvement.
Our Operational Improvement Plan has made also significant contribution to EBITDA. On last twelve months basis, EBITDA has increased by 20%, with a significant margin expansion. Slide 17. Considering this significant margin improvement, we're now very confident in our ability to achieve the high end of our previous EBITDA guidance. We expect full year 2023 total revenue growth of 10%-12% at constant currency, which is supported by Biopharma revenue growth of 12%-14% at constant currency. Regarding EBITDA margin, now we expect for the second half of this year to be at 25% from the 24%-25% previous range, and 24% margin plus for the full year 2023. All of this confirms our adjusted EBITDA guidance of EUR 1.450 million by the end of the year.
If we consider the annualized cost savings, the pro forma 2023 EBITDA margin would be in the 28%-29% margin range, bringing us back to the pre-COVID margin levels. Slide 18. Building on all efforts made through previous quarters, we continue to make solid progress on our deleveraging path, down to 6.7 times at the end of September of this year. This has been driven by EBITDA improvement, backed by business performance, cost savings, and operating cash flow improvement. We remain confident to achieve a leverage target of 4 times by the end of 2024. Our current liquidity is more than 1 billion, including 454 million in cash. Now, I hand over to Thomas for the final remarks.
Thank you, Alfredo. Maybe to put all of what you have heard into perspective, last year, we embarked on a journey to turn around Grifols' financial performance, as well as to build an increasingly performance-oriented, efficient, and accountable organization. The Q3 has been testament to that we are well on the way to meet our objectives. Our fundamentals have never been as solid, and we have delivered a strong performance across the board, executed on our key priorities, and very importantly, delivered on our commitments. One, we have grown our revenue sustainably. Two, we have enhanced profitability and have sequentially updated our EBITDA guidance for the full year 2023 accordingly, and remain on track to reach 2019 EBITDA margin levels next year.
And three, driven by all of these improvements and a commitment to deliver a deleveraging transaction of at least 1.5 billion still in 2023, we will strengthen our balance sheet and are on track to reach our guidance of 4 times by 2024. At the same time, we are not losing sight of what's ahead of us beyond 2023. We are now very focused on realizing Grifols' full potential, and in doing so, maximizing value for all stakeholders. Our efforts will concentrate on a number of strategic levers. One, we will build on where we see our core strength and the best competitive advantage. Two, we will continue operating as a global market maker and shaper in our markets, seizing those commercial opportunities that are most promising and hold great potential.
Three, we will continue to accelerate and bolster innovation, focusing on a select number of therapeutic areas, and prioritizing those projects in our pipeline that will boost our profitability and differentiate us with our customers. Under the leadership of Jörg, the architect of Fibrinogen and Trimodulin, we will strategically strengthen innovation as our future growth engine for Biopharma. Four, we will continue to enhance donor attractiveness through personalization of the experience, digitalization, and streamlining of processes.
Five, we will also continue to improve our business and operations through further process optimization, streamlined operations, and digitalization to drive efficiency. And six, as a market leader, we will explore new markets and business opportunities while we enter into agreements to deliver groundbreaking, differentiated patient and customer solutions. Importantly, these six strategic pillars will be backed by a performance-oriented management team and a strong people and talent development culture.
We will build on the current progress and momentum while maintaining strong financial discipline, both with regard to P&L and balance sheet management, to ensure strong, sustainable, long-term financials. In the coming quarters, we will give you more details of all our strategic levers and update you on the progress as we continue to deliver to our commitments in the short term. I want to conclude by reiterating how encouraged I am by all our progress in the first nine months of the year, and I do want to thank the entire Grifols team for their hard work and dedication. I appreciate your attention, and I now turn it back to Nuria, who will open it up for discussion. Thank you.
Thank you, Thomas, and thank you all for your time. Now let's start the Q&A session. Just as a reminder, you need to press star five to ask a question, and we need to stick to two questions per analyst. If you have follow-ups, you can dial star five again, and then we will place you once again in the list. After your question, we may need to put you on mute to avoid background noise. Okay, so we have already a few requests for questions. First question today comes from Tom Jones, from Berenberg. Good day, Tom. Hello.
Good morning. Or good afternoon. Thank you for taking my questions. Kind of both of them really relate to the tech transfer agreement that you've recently signed with Biotest. One is just a straightforward financial one, really. I think Biotest this morning guided towards somewhere around a mid-triple-digit million number payments in total over the 2023, 2024, 2025, 2026 time frame. It would be helpful for us to try and understand sort of broadly how that might be weighted, just to help us modulate your sort of free cash flow over the next couple of years.
And then related to that, sort of related to the master distribution agreement you also have with them, just wondering how you're intending to position Yimmugo, their novel IVIG product against your existing Gamunex and Xembify brands, and how you make sure you don't cannibalize each other inadvertently and ultimately create the most revenue and value across the entire IVIG franchise with all of those products. So some idea of the sort of commercial marketing strategy for those different IVIG products would be helpful, I think.
Thank you, Tom, for your question. Regarding the transfer tech agreement with, with Biotest, you know, basically, this is, you know, what you, what you have seen in the, let's say, press release, is on a standalone basis, on a, on a consolidated basis, you know, it's a wash. I mean, you know, the, the payments related to this, agreement, will be, will be done based on the, cash flow needs of Biotest, so, it will not be an impact on consolidated basis.
Hi, Tom, good afternoon. I take the second piece of your question. It's about the positioning of Yimmugo. As you know, in Grifols, we have two main intravenous brands. One is Gamunex, and the other one it's Flebogamma. Our idea is to, due to basically, the better years that Yimmugo has compared to Flebogamma, is to, with time, once the product is approved in different countries, to commercially switch from Flebo to Yimmugo. This is kind of, in summary, the strategy we are pursuing.
That's really helpful. I mean, I know I'm only allowed three, but it's a really quick one. The 13.7 million of restructuring charges in Q3, which line item were they booked in? Just helps us tidy up our models.
Well, depending on, on... I mean, if we're talking now severance, you know, there are book severance for, I would say, for the manufacturing area or from, or from, I would say, corporate structure. They go either to COGS or to, or to, SG&A. I mean, for further details, you can follow up, you know, the, all the specifics with, with my team.
. Okay, will do. Thanks very much.
Thank you, Tom. We have a question now from James Gordon, JPMorgan. Hello, James.
Hello, James Gordon, JPMorgan. Thanks for taking the questions. Two questions, please. First one was on divestment plans, and the question was just, what is the cause of it taking maybe a little bit longer than we thought to, to close? It has been about five months since the June update. Is it that you're looking to do something more complicated, like maybe a, a combined transaction, divesting some of Shanghai RAAS and, and Diagnostics, or, or some factors related to dynamics in China at the moment? Or why has this taken a bit longer, and, and why are you still confident? And then the second question was just on Biopharma growth.
Strong performance in the quarter, I think it was 14.5% year to date, and 13.7% in the quarter, but you're still guiding for the full year to grow 12%-14%. That's quite a wide range with only two months of the year left, and it does imply potentially quite a slowdown in Q4. So is that just conservatism, or is there some tougher things going on in Q4? I can see you've maybe got a tougher comp for Biotest, or is it, like, industry dynamics with Alpha-1? Why might things theoretically slow so much in just the last few months of the year?
Hi, James. This is Thomas. I'll take your first question, and first of all, let me just remind you that, you know, Shanghai RAAS, which obviously is the asset we're talking about, is extremely attractive, and there have been many, many people that have an interest in this asset. Now, also, this being a China transaction, it's a very complex environment to negotiate. We do wanna make sure that, you know, that this turns out to be a good transaction, both in the short and long term, for Grifols, so that has taken time.
We obviously wanna make sure we cross all the I's and T's, but it's really not more than the fact that, you know, getting anything done in China does take a lot more time than if you were to do it in Europe or the United States.
Okay, I take the second part of your question. No, we are fully committed to meet our targets of revenue growth, both combined with Biotest and Biopharma on a standalone basis. It's fully there.
Thank you, Víctor.
Thank you, but I think it was just that the full breadth of the range would imply that there might be quite a slowdown. So is it just you don't want to change the range at this time? 'Cause to get to just 12%, you'd have to have quite a slowdown versus what you've done in the first nine months.
We have had a very strong, in fact, Q3 . For Q4, we are stick to our budget, and, if comes as good as Q3, we will try to deliver, of course, but it's kind of, you know, this quarterly thing, sometimes the swings are not really, let's say, underlying reality.
Thank you.
Thank you, James. Next question is coming from Thibault Boutherin, from Morgan Stanley. Hi, Thibault.
Hello, thank you for, thank you for taking my questions. Just one on albumin to start. I mean, the numbers seems to imply you had very strong acceleration of your albumin sales in the Q3. So just want to understand what happened there. Is there any one-off? So the first question, and second one on deleveraging, and beyond the Shanghai RAAS stake sale, that you, that you kind of confirmed, do you have an appetite to do another transaction before the end of 2024? And how large this deal would need to be in order for you to get to your, to your leverage target? Like, does it need to be as big as, as Shanghai RAAS, or could you do something smaller and get there? Thank you.
On the albumin question, no, we are seeing a strong momentum or in albumin both in China and other important regions globally, and we are meeting our demand. As the plasma is coming back, we are meeting this demand that it is out there for us. So it's perfectly in line, and it's fully, let's say, controlled.
Hi, Thibault, Thomas here. We are actually very focused now 100% on signing the China transaction and are actually, at this point in time, not looking at anything else. We believe that the organic deleveraging, you know, combined with the transaction, is gonna get us to the target that we set for ourselves for 2024.
Thank you, Thomas.
Thank you.
Then, next question is coming from, Alvaro Lenze from Alantra Equities. Hola, Alvaro.
Hi, thanks for taking my question. The first one is, if you could provide some additional detail on the evolution of Alpha-1? Sales seem to be a bit weak. I don't know whether it's that final demand or increased competition from other plasma players. And the second is if you could provide some guidance on cash flow. I see that investment in working capital remains very high. I don't know if we should expect continued investment in Q4 and, and also in, into 2024. Thanks.
I take the first one. Good afternoon, Alvaro. On Alpha-1, yeah, as we said, we are seeing today a kind of flattish evolution in this franchise for us. There are many, many components. As you know, we have a pretty unique, let's say, business model when it comes to commercial, especially in the U.S. and our historical markets. After the pandemic, we are fine-tuning this model. This model, as you know, a key important factor for the model is the first piece in the funnel, it's the testing, the testing piece. Just in May, we launched the new testing tool, which is the AlphaID At Home, which is the complement to the healthcare professional testing model. So we are fine-tuning there.
We expect this, let's say, flattish trend seeing recently, will be turning it around during 2024. As I said, we make some small tweaks in our operating model to adapt to the new times after the pandemic.
Well, Alvaro, to your question of, of the cash flow, you know, in the Q1, you know, we have, you know, that hit, as, you know, the restructuring, cost. You know, most of the payments were done in the Q1, and since then, we've seen a, a significant, you know, positive, increase on, on cash flow, and we're gonna see this in not only in Q1, Q... I, I mean Q2 and Q3, but also in Q4. Regarding the inventories, yes, we're seeing, you know, some increase in this quarter, but, year- to- date, we are, in the same days, inventory days around, 300, which is in line with, with the previous year.
Remember that, you know, just by maintaining the number of days, but due to the increase of the activity, I mean, the sales activity with this double digit growth, this require additional inventory. But for the year end, you know, a very positive cash flow before debt service.
Thank you. Thank you, Alfredo. We have a question from Guilherme Sampaio, from CaixaBank. Hello, bon dia.
Hello, thank you for taking my questions. So first one, a follow-up on this previous question. In terms, specifically in organic deleveraging, so we keep seeing, net debt going up. When should we see a decline in net debt? So whether next quarter or something for the next year, actually, of course, the effect of the deleveraging transaction that you are anticipating? And second, if you could touch upon the slowdown in the diagnostic area that we've seen specifically in this quarter?
Okay. For the first question, I mean, the net debt reduction will be seen, you know, primarily, on the back of the cash proceeds, you know, coming from the divestment. Because even though we see that our operational cash flow is gonna keep improving during this year or next year, but, you know, we need to deleverage, to reduce, basically, you know, the interest expense.
On the diagnostic question, you talk about the slowdown, I think, in this quarter. If I understood correctly, it's good to remind that in Q2, we had an exceptional, let's say, revenue or income coming in this one. That, of course, it's an exceptional one, and it's not happening in this quarter or the others to come.
Okay, good. Now we have couple of follow-ups. So, Tom, I think you have some additional questions?
I did it. I was just one really. It was, it was a broader follow-up question, around your, your, your kind of building pipeline. And if I, if I look across everything, you've got, you know, a building number of assets, whether it's the two Giga products, 564, and 2339. You've got the Alkahest AMD product, the 4290 product. Then there's 6019, and 6021, I think, from Alkahest as well. Plus, you've got the Alzheimer's vaccine. You know, you've got all these sort of non-plasma, like some of the Alkahest ones are plasma products, but you've got a lot of kind of non-core products building up in the pipeline, which is great. But I, I just wondered kind of what your long-term thinking around the development of these products is?
'Cause, to be frank, at the moment, the market just puts a multiple on the R&D spend of them. I don't think anyone's got a penny of revenue in anybody's model for any of these products. So as it sits today, they're a bit of a drag on the equity story. So I just kind of wonder what the long-term strategy is. Is it to keep these, take them all the way through to development and marketing, or at some point, do you think you'll start out-licensing some of these products and tying up with people who might have more expertise in late-stage oncology drug development? I just wonder what the kind of big picture here is, because at the moment, you know, they're all cost and no benefit from the equity market's perspective.
Thank you, Tom. Yeah, it's a very, very good question from your side. Yeah. Clearly, trimodulin and fibrinogen will play a key role here, as Plasma will be in our core, both in the day-to-day, in commercial and manufacturing, but also for our future developments. So Plasma clearly will be in the core with those two products and the complement coming from our lifecycle management that we are doing in different products. On those new technologies, for instance, on GigaGen, when we made the acquisition of this asset or this technology, I should say, was in line with our Gamma globulin product portfolio.
We saw that an interesting opportunity in the way we can obtain Gamma globulin or a specific Gamma globulins from this technology. It happened that that company came also with this oncology interesting initiatives or programs there, and we just wanted to continue them. Going forward, if some of them are successful, we are clearly open to this, to define and decide whether this remains in our core, and we, let's say, expand to oncology, or we kind of out-license whatever is the form for those, let's say, non-plasma, non-plasma programs.
Okay, that's very clear.
Thank you. Now, Alvaro, also follow up. Hello?
Yes, thanks for allowing me to jump back in the queue. Just two questions. First is on capacity and considering the fast growth in activity. If I am not mistaken, I believe in Q2, you mentioned that you were around 60% capacity or something like that. If you could provide us an update on how that is trending, and when should you return to higher CapEx spending, as CapEx is currently running lower than it has in the past? The second question is just if you could provide some guidance on the evolution of minority profits attributable to non-controlling interests.
They have been trending a little bit higher than I expected. There's little visibility, as some of the companies here do not have reported EBITDA, like the collection, plasma collection networks of Haema and Biotest U.S. Whether we could extrapolate this 30 million per quarter, like, indefinitely, or if you could provide some guidance for this year and next year? Thank you.
Okay, you know, I take both questions. You know, regarding capacity, you know, yes, we confirm, you know, in the last call, the 60% capacity, you know, for this year. You know, based on the upcoming sales growth and our projections, we expect that the next wave of CapEx expansion will take place in 2028. Okay? So we have clear path, so, lower spend from now to 2028. Regarding the minority line within our P&L, for your model, you can extrapolate 100 million per year.
Thank you.
Okay. Apparently, there were two persons who were trying to access and were having some kind of problems. We will try to give access from our side. We have Peter Verdult from Citi. Are you... Can you hear us, Peter? No? Okay, we'll- No. Okay, we'll try again later. And then, Charles from Barclays, Charles Pitman? No. Okay, let's... While we solve this, let's continue with Thibault, who you also had some follow-up. Can you hear us?
Hello, can you hear me? Can you hear me?
Oh, yes.
Yes. Yes.
We can hear you.
We can.
Okay, perfect. Perfect. So, first question on the funding of the Alzheimer vaccine, potential phase III. Just wanted to know if you're kind of open to out-licensing this or finding a partner to fund the R&D, or if you're willing to fund it yourself. And then, second question: when we think about the underlying adjusted EBITDA this year, you know, pro forma, including savings, the 1.75 billion, you know, how, how, how comfortable are you with kind of consciously using this as a base, you know, going forward, and using it as an underlying profitability guide for next year?
Is there any kind of accounting element or business element we need to think about that would make it not a good approach to do that? Thank you.
I think that this part of the question about the Araclon vaccine. Yeah, this was an important milestone for us, that we have been waiting, the phaseII clinical trial and data out of that. As you have seen, very positive data across the board. The idea, and this is linked to a previous question, yeah, we are very open to study potential out-licensing this product for the phase III.
Thank you, Victor. Apologies, Thibault, but we could not hear you very well, the second part of your question. Can you, can you summarize? It was on the accounting.
Yeah, of course. It was just, are you comfortable with kind of analysts and consensus using the 1.75 billion of underlying adjusted EBITDA margin that you are guiding, including all the pro forma, savings? Are you comfortable with this being used as a base when you think about EBITDA next year, so basically, you know, including growth, for next year? So basically, you know, what consensus is, is basically using this number as, as a base for this year and, and going it next year. So just want to understand if, if you're comfortable with this approach.
Yes. Yes, we
We could hear you very well this time.
Okay. Now, thanks, thanks for repeating the question. Yes, we are comfortable with this 1,750, considering this, you know, cost savings that they're gonna go into 2024. So therefore, yes, the... Remember that, out of the 450 million operating cash savings, 150 million roughly will flow through the P&L this year and, and 300 next year. So that's why we- that's, that's how we come up with this 1,750. So, so yes, we reaffirm that we're confident.
Thank you.
Hello, we have a question from Jaime Escribano, Banco Santander. Hola, Jaime?
Hi, good afternoon. So a couple of questions from my side. Regarding the gross margin, if Grifols is standalone 41% in Q3, we look at 2019, where Grifols was making 46%. But the cost of plasma keeps going down, and I remember you mentioned that in Q4, we should see the fully loaded or almost fully loaded impact of the cost-saving plans. I wonder, how do you see this 46% gross margin affordable in following quarters? And even if we could think about a gross margin higher than that? That would be my first question.
Okay, Jaime. Yes, as you know, we need to consider in our industry this nine months accounting lag for the plasma cost. As I said, you know, out of the 450, 500, 300 are coming next year, so they're gonna go through the P&L. Most of these 300, which the majority relates to plasma cost. Yes, we're gonna see that this gross margin is gonna keep growing on sequential basis, which basically, you know, this higher gross margin is at the same time, is gonna, it has a very positive impact on the quarterly EBITDA improvement in the coming quarters.
You had a second, Jaime?
Yep. Yes, my second. Sorry, I think there is some echo. Yeah, no, it was regarding the Canada plant. When do you think we can start seeing revenues coming from the new manufacturing facility there? And what could we expect?
We were there a few months ago, the whole team, meeting within our Canada plant. I can tell you that the CapEx is progressing, the finishing of that. We can expect to see some production coming out of this facility in during 2025.
Okay. Thank you.
Thank you. Now I think we have recovered from Barclays, Charles Pitman. Charles, can you hear us now? And whether we can hear you. Hello.
Hi. Can you hear me now?
Yes, yes. Apologies for that.
Amazing. No, no worries. Thank you very much for taking my questions. Just a couple on the Shanghai RAAS deal. I was wondering if you could just provide us with a little bit more detail around what the regulatory hurdles and approvals are that you are currently navigating with this deal, and what approvals do you need and when to kind of get confidence that you can announce this signing, that, you know, you. And kind of, if you could just reiterate what gives you confidence that you're able to sign this by the end of the year? And then just secondly, on the kind of $1.5 billion of cash realization, can you confirm if this is a pre or post-tax amount? And, and what gives you the confidence that you can, in fact, realize that?
Can you just reiterate that you are confident you'll be able to realize that cash, and you'll be able to use that to pay down debt? Thank you very much.
So let me take the first part. First of all, at this point, we are very confident that we can take the transaction across the finish line before year-end. Because at the end of the day, it is the regulatory, some of the regulatory pieces will come into in next year, in the H1 of next year, so that's not preventing us from the signature as such. So we're gonna sign, and we are pursuing the regulatory, and as we said, we expect that the closing will take place in the H1 of next year.
Regarding the cash proceeds, this at least $1.5 billion, you know, this cash proceed will be used in full to reduce debt.
Okay, and,
Thank you
Also, we have Peter Verdult from Citi. Hello. Peter?
Nuria, can you hear me?
Yes, perfectly. Thank you.
Thank you. Thank you, everyone. Peter Verdult, Citi. 3 questions, please. Thomas, for you firstly, when you initially put that press release out in June, you talked about the transaction and remaining a significant shareholder in Shanghai RAAS. So could you maybe reconfirm that, or have things changed? And can I be cheeky and ask, what, in your view, is a significant shareholding still in, in RAAS post the transaction? Question number two, maybe for Victor. I think it'd be helpful for us in the market, good growth on Xembify. It's a long-term growth driver. I think historically, you've said 5%-10% of sales coming from, of IG sales are Xembify. Are you willing to put a ballpark number as to where we are end of this year, where we are on Xembify?
Then lastly, I joined late, apologies, but I did hear James Gordon's question about the guidance. Can I just invert it and make it more simple? Is it fair to say that the risks, given the trends you're seeing so far in Q4, that the risks to your guidance is very much to the upside rather than downside, as you know, as James was implying, in terms of mechanically going, you know, keeping that 12-14? So three questions on RAAS, Xembify, and upside risk to guidance, given the Q4 trends you're seeing.
Okay, I'll take the first question, and I appreciate it. With regard to, you know, our ownership and all of that, we're gonna let you know all of the details once we announce and once we sign. But I do wanna remind you that we have a strategic alliance with Shanghai RAAS, and we have an albumin distribution agreement, both that are very important to us. And also our future position in China is important to us in a strategic market. So as we, you know, proceed with this deal, all of these pieces will be a very important part as we conclude and sign the deal with Shanghai RAAS.
On the second question. Hello, Peter. As you probably can see in the presentation we released today, the growth pace of subcutaneous versus our IV product, it's clearly higher. So this is as we move every month, every quarter, the share of subcutaneous versus the overall, it's increasing, and we expect this to continue to continue. I don't know exactly up to which level, but we expect this to represent, with the time, a significant mix in our IG portfolio.
On the... Alfredo, on the guidance-
Guidance
on the risk.
Yes.
Regarding the guidance, I mean, as you know, the growth is, you know, is very important to understand that it is based on the baseline, okay, of previous year, and also on, you know, on when you look at on reported basis on the effects. You know, for the Q4, we expect that, we still expect a strong quarter. But the reality is that, when we look at the amount, the amount of the Q4 is gonna be higher than the previous quarter. However, the baseline varies from one quarter to another quarter when you compare with previous year.
But, said that, we reiterate this range for net revenue guidance for the year end.
Thank you. We have. We are coming close to the hour, but we have two follow-ups, one from Jaime, another one from Charles. Please, if you can, make kind of one question each so that we conclude with that session. First, Jaime.
Hi, thank you. Yeah, mine is fairly quick. It is regarding the pipeline. So you announced the Alzheimer vaccine results, first read out quite recently. Just to know what could we expect following the steps? And is this a big opportunity for you, or can you try to give us some kind of sense how excited you are with this? And just a very quick one also related with the pipeline, which is the ASFA in 2018 said that they were going to review the guidelines and that in 2023 they would start recommending again products.
Is this something that could be on the table again, you know, to try to revive the AMBAR project with the ASFA, or you don't have a lot of expectations on that? Thank you.
Thank you. Yeah, on the Alzheimer, the Araclon vaccine, there was a question previous and, yes, it's a thing. It's a, it's a program that we are open to out-license, the financing of this phase three trial that it should go now. So, that's the status as of today on Grifols regarding this vaccine, looking for a kind of a partnership here. On the ASFA inclusion of the AMBAR protocol into their guidelines, yes, it has been included in one of the guidelines, so now it's a procedure that can be used out there for patients. Regarding the AMBAR in general, for Grifols, we are kind of in a standby mode. We are in talks with regulatory agencies to see opportunities on how to proceed. But to the ASFA question, yes, it has been included.
Okay, and I'm sorry, Victor, just to follow up, but then, is there any opportunity to monetize AMBAR through this recommendation of the ASFA, or to get it into the insurance or any growth potential coming from there?
At this stage, we are, let's say, moving cautiously, I should say, in the sense of slow, okay? We, we are trying to understand which are the potential possibilities that we can see for this program, in relation with the inclusion of the protocol in the, in the ASFA guidelines.
Okay, and last question for today's session, Charles. Hello, Charles Pitman.
Hi. Thank you very much. Just very quickly, can I just wanna just get this 100% clear, th 1.5 billion you expect to receive in payment, that's a post-tax amount? And then just the actual question I had follow-up was just talking about the expected potential for other cost savings, given you've now hit the kind of top end of your target for FY 2023. Kind of what other further levers are there that you're seeking to identify going forwards, or is the focus very much just on normal operational efficiency? Thank you.
Okay. For the 1.5, this is gonna be cash. I mean, cash, you know, I mean, no, no taxes. When you receive the cash, there is no taxes on this. And then, regarding the operational improvement plan, as we said, you know, this year we're gonna achieve through P&L the 150 plus the 300, as I said, for next year, the 450. I think that, I mean, we continued working to exceed that 450. There are some opportunities already mentioned by Victor on the manufacturing side, so this is a nonstop, I would say, working, and I'm pretty sure that more savings will come in the upcoming quarters.
Thank you, Alfredo, and thank you everybody for joining us today, and expect to talk to you very soon. As always, any follow-up, any other questions you may have, you can contact us as the Investor Relations and Sustainability Department, and we'll be happy to take other questions also from all participants. Thank you very much.
Thank you very much, everybody.
Thank you. Bye-bye.
Thank you. Bye-bye.