CSL Limited (CSL) Earnings Call Transcript & Summary

Thank you for standing by, and welcome to CSL's Interim CEO 90-day Review and Financial Update. [Operator Instructions]. I would now like to hand the conference over to Ms. Michelle Rees, Head of Investor Relations. Please go ahead.

Good morning, everyone. Thank you for joining CSL's Interim CEO 90-day Review and Financial Update. I am Michelle Rees, Head of Investor Relations. Before we begin today, I'd like to draw your attention to the important disclaimer on your screen. A copy of this, along with our ASX materials have been published on the CSL and ASX websites. With me in Melbourne today is Gordon Naylor, CSL's Interim Chief Executive Officer; and Ken Lim, Chief Financial Officer. Please note, this briefing is being webcast. I'll now hand over to Gordon.

Good morning, everyone, and thanks for joining us this morning. My name is Gordon Naylor, and I'm the Interim CEO and Managing Director of CSL. The purpose of today's call is to brief you on the steps that we are taking toward turning the company around and returning it to profitable growth. We're also providing a nearer-term financial update. The last 10 weeks have been incredibly intensive, but I've been helped by my own deep experience at CSL, the full support of the Board of Directors and our remarkably resilient and capable people. Recognizing that the organization has been and continues to go through a great deal of change, my first priority was to steady the ship in part by visiting most of our major business sites around the world. I've talked to hundreds of people, led around a dozen town halls and engaged directly with many of our key business partners. In addition to running the business, my role includes giving the Board the space to choose my successor and for me to actively lay the groundwork for that person's success. The review of the business was very helpful and has given a sound foundation for forward decision-making. In addition, that review was the basis for a comprehensive review of the balance sheet. Our invested capital is around $32 billion, and it's clear that not all of this is working as hard as it should be. I will take you through the first item here, then Ken will take you through the financials. We'll then open the floor for questions. We fully recognize that CSL's financial outcomes have fallen short of expectations. In order to turn this situation around, it was important for me to understand what has changed in the last decade or so. I was especially interested in what could be attributed to external factors versus our internal decision-making. Our analysis started with a shareholder view of CSL's financial performance over the last decade. Looking back at least 10 years was important given the long-term nature of this business. We use the published financial reports and standard analytic tools supplemented with microeconomic perspectives of the business, along with analysis of key internal and external events over that period. The look back is complete and is now informing our immediate actions and strategies, including continuing many of the measures that the Board of Directors and the management team had previously initiated. I have no doubt our strategy remains the right one, which is to strengthen our core while investing selectively beyond plasma and logically adjacent spaces. I must say that when I took on the role, I was worried that the valuable culture of the company may have been damaged in some way. Today, I'm very confident to say that the leadership of the company and the workforce are highly engaged, talented and committed to restoring the company to success. Staff fully understand the broader societal role that the company plays. I'll talk more about plasma therapeutics, but it is pleasing to see CSL continue to explore growth opportunities within the rare disease space. Recognizing that there is a need for change and that financial outcomes need to be better. It is worth noting that the company is very profitable, has metronomic cash flows and significant financial capacity. I can also see that CSL continues to have evident competitive strengths in plasma collection and influenza vaccines. The core plasma therapeutics industry has continued to grow strongly, driven by underlying demand for the critical therapies and macroeconomic growth. What is also interesting is that the industry structure is largely unchanged. The names are a little different, but we continue to have a small number of global vertically integrated players, each producing a modest number of fairly biogeneric products from human blood plasma. These players all have cash-sensitive ownership. There have been some alternative therapies for some Ig indications emerge, but new market opportunities have also opened up, such as secondary immune deficiency. This tells me that the unique microeconomics of the sector are unchanged. The industry is fundamentally structurally stable and growing. The absence of patent cliffs means that the market structure is highly durable. And as you can see from the data on this slide, considerable runway remains for future growth. The challenge is whether CSL has continued to compete as effectively as it once did and to respond to intra-industry dynamics. The premium of our gross margin structure over competitors suggests that the core is sound, but its decline over time also suggests that we're not as good as we were. The good news is the changes that we're making are largely to deal with issues that are under our own control rather than external to the business or structural in the markets where we operate. Turning to our 10-year look back. The red line shows the share price over the decade. That's a familiar story to long-term shareholders. The black line shows earnings per share. It's evident that over the long run, the company has continued to generate significant profit, and this continues to be the case today. It's not on the slide, but free cash performance has also been very strong. This has given the company the opportunity to return surplus cash to shareholders through dividends and buybacks, such as the one we just completed. The light gray line shows the return on invested capital over that period. ROIC is a reasonable accounting measure of balance sheet productivity and has declined over that time. Putting the pieces together suggest that, firstly, the decline in ROIC has primarily been driven by a growing asset base, some of which has been less productive than anticipated. Ken will talk more about this shortly in the context of the balance sheet impairments. I also expect that we can be more efficient managing our working capital. Secondly, the failure of several late-stage R&D projects, along with some market share losses in key markets has contributed to a loss of confidence in the growth prospect of the business. There's more to the diagnosis, but this captures the essence and is certainly enough to inform our forward-looking decision-making. Let me make a couple of high-level comments on our corrective actions. Firstly, we're returning to being more outward looking, better understanding our patient needs, the evolving science, competition and public health. Secondly, there is no fundamental shift in business strategy. This is primarily about excellence in execution. And thirdly, many of these initiatives were already in flight. In some cases, the heavy lifting has already been done, but the benefit will take time to realize. We are completing these initiatives with urgency. It is useful, I think, to consider some of these approaches in financial terms. The company generates significant cash flow from operations. Apart from projects that are of a compliance or safety nature, every other use of that cash has to be justified on a risk-adjusted discounted cash flow basis to demonstrate that it is expected to generate returns appropriately above the company's cost of capital. Surplus cash is then returned to shareholders through dividends and on-market buybacks while maintaining leverage within our published target range. This framework is unchanged from the past, but is very much core to our forward approach as well. I'd also like to highlight our efficiency measures. It is clear that the company had overbuilt organizational capacity, and this is now being addressed. These changes will be evident in the P&L going forward. In addition, we are very focused on reducing the marginal cost structure of the business, especially in plasma collection and fractionation. This is a core driver of Behring's gross margin structure, and we do see opportunities here that will improve profitability and also competitiveness. Allocating clear accountability to plasma collection leadership and elevating the operation to report directly to me will accelerate innovation in that part of CSL. An extensive transformation program was announced in August of last year, aimed at simplifying and streamlining the business. I'm pleased to say that very good progress has been made in this program. To highlight a few points, the R&D organization has been considerably streamlined with a much tighter governance structure built around a strict financial framework in addition to science, medical and commercial insights. Success can never be guaranteed for individual projects, but we are very thoughtful about which horses we back with early signs of success such as VarmX. In addition, the simple reduction of fixed cost will benefit the P&L. We are very confident about the Horizon 2 program, but are taking a measured approach to capital investment to support the new manufacturing process. Integration of the Behring and Vifor commercial operations is yielding synergies. Both are primarily rare disease franchises. One of the industry changes that the company was slow to respond to was the growing capability gains of our plasma industry competitors as their supply chains became more robust and their product portfolios progressed and in some cases, overtook us. This resulted in market share losses and lower growth. For example, we are now the third largest Ig player by volume in the U.S., although we do retain global volume leadership. In response to these circumstances, we are making targeted investments in our commercial capabilities, and these are beginning to yield results. The operational separation of Seqirus is now largely complete. This retains flexibility for CSL in terms of a potential demerger when the timing is right and gives Seqirus the direct capability and accountability to continue to drive market share gains and look for growth opportunities. Because there are only modest synergies with the rest of CSL, the separation has not added any incremental costs. We've increased the focus and accelerated the cadence of the executive leadership team and stopped or deferred a number of in-flight initiatives that were not core to the primary objectives today. I expect that the result of these steps will take some time to flow through the financial accounts, but we are seeing some encouraging early indicators. As you know, our biggest product in our biggest market is U.S. Ig. Growing market share for the intravenous presentation, PRIVIGEN has been challenging, and we've been losing share with the subcutaneous presentation, HIZENTRA, following new entrants in that space. This is end market data on the slide, so subject to in-channel inventory movements. The good news is that we're beginning to see the reversal of these trends. Following some market volatility in the Chinese albumin market, we're also seeing some early traction as we grow a little faster than that market. Profit growth requires expansion within rare diseases beyond the traditional plasma therapies. So it's pleasing to see ANDEMBRY and HEMGENIX going well. Seqirus is the sectoral leader in influenza vaccines. The headwinds from vaccine policies and fatigue after COVID have been challenging but have afforded an opportunity for Seqirus' innovative product portfolio to shine, driving the market share gains forward. It's a great example of a market rewarding innovation. Having an orderly leadership transition plan is critical for critical for CSL as we navigate through these changes. In addition to the work that I'm doing as Interim CEO to stabilize the organization and initiate a strong return to growth, part of my role is to give the Board the space to identify and appoint my successor. We suggested at the half year that this process would take about 12 months and is progressing as planned. For the avoidance of doubt, I've chosen not to be a candidate in the process, but I do anticipate that I will return to the Board as a Non-executive Director once I have completed a transition to the next CEO. As a result, along with my fellow Board members, I'm actively involved in the CEO selection process. It also means I will be well placed to support the transition for the new CEO so that it is as smooth as possible. This is critical for business outcomes as well as shareholders and our people. The Board is also actively engaged in Chair succession and is very well aware of the need to maintain strategic momentum and stability as we move through these important leadership changes. It goes without saying how valuable the support of all members of our Board of Directors has been to the leadership team as we've all worked through the many challenges of the past few months. It is with mixed feelings that I must share with you today, Andy Schmeltz's decision to retire from the company at the end of the financial year for personal reasons. Andy is largely responsible for the retooling of the Behring commercial operation in response to the changed competitive environment as well as the integration of the Behring and Vifor commercial and medical affairs functions. We've all enjoyed working with Andy, and I do offer Andy and his family our very best wishes. I am pleased to advise that Diego Sacristan has been appointed to succeed Andy in this critical role and to continue the important transformation of the operation. Diego comes with an impressive commercial pedigree from Pfizer, having served in numerous senior roles, including as global marketing lead. Since joining CSL in 2024, he has led the international and U.S. Behring commercial operations reporting to Andy. Andy and Diego deserve credit for the green shoots that we're seeing. Diego will now take the good work forward, and Andy will remain available to support Diego through the transition period. Diego has joined us today in Melbourne and is available to answer questions about the commercial operations of Behring and Vifor. I'll now hand over to Ken to take you through the updated outlook and the impairments.

Thanks, Gordon, and good morning, everyone. The actions we're taking to return CSL to profitable, sustainable growth are the right ones, but the translation to financial benefits will take time to realize. As Gordon mentioned, the transformation program is progressing well and is delivering savings a little ahead of expectations. Although nearing completion of the original plan, we see some further opportunity here, and we'll look to make some more comments on that when we report our full year results. Fiscal '26 represents a year of two very different halves. While CSL Behring was down in the first half, we do expect to see growth in the Behring portfolio for the second half, measured against both the prior corresponding and trailing periods. While encouraging, second half growth will be below the expectations we had in February. At the first half results, we called out ambitious growth expectations for Ig, China albumin and our launch products. Regrettably, those ambitions have not been fully realized. Let me walk you through the key drivers of the revised guidance we're providing today. In the U.S. Ig market, as you've heard, underlying demand is in line with our expectations of mid- to high single-digit growth, and we're pleased to be seeing market share gains. Since February, however, it has become apparent that we had excess Ig inventory in the channel, causing a disconnect between end customer demand and the sales that CSL reports. While this excess channel inventory has now unwound to normal levels, it has driven a headwind of approximately $300 million in U.S. Ig sales compared to our previous expectations. In China, we are taking share and market volume for albumin has stabilized. However, the market continues to decline by value. As a result, FY '26 albumin revenue will be around $200 million lower than previous expectations. And finally, there is a further $150 million reduction in revenue from some smaller impacts that have occurred in the time period since our February results announcement. The conflict in the Middle East has resulted in a pause of sales into Iran. We are seeing slower-than-expected growth in HEMGENIX, partly due to a temporary supply challenge, and we continue to see heightened generic competition in the iron market. Turning to our updated outlook for fiscal year '26. We now expect revenue in constant currency to be around $15.2 billion, down 2% on fiscal year '25. NPATA, excluding restructuring and impairment costs at constant currency will be around $3.1 billion, down 4% on fiscal '25. In addition to a revised constant currency outlook, we're also updating our estimate of foreign currency impacts. Recent geopolitical events are causing heightened FX volatility. Assuming current foreign exchange rates prevail for the remainder of the financial year, our reported revenues would be approximately $400 million higher than the constant currency result and reported NPATA would be approximately $20 million lower than the constant currency result. Gordon spoke earlier about some less productive assets on our balance sheet. We expect to recognize noncash impairments of around $5 billion in addition to the impairments already taken at the first half. The key drivers of these impairments relate to CSL Vifor intangible assets and selected property, plant and equipment. The Vifor impairments reflect reduced expectations for the business, including the impact of generic competition on the iron portfolio. We're also reviewing our fixed assets, in particular, the carrying value of facilities that may not be fully utilized. We're working through the details of these impairments, which are likely to be recognized over fiscal year '26 and '27. An update will be provided at the full year results announcement in August. I'll now hand back to Gordon.

Thanks, Ken. Before we open for questions, let me just summarize briefly. Our retrospective review was important for us. It gave us clear signposts confirming that the transformation work that our Board of Directors and management team had commenced was important. It also suggested that a thorough balance sheet review was needed. We haven't completed that review work, as Ken mentioned, but the impairments that were discussed are recognition that circumstances have changed materially since major investment decisions were made. Our green shoots are encouraging, but there is considerable work ahead before our current financial performance can be considered satisfactory and CSL returns to sustainable profitable growth. I'm confident that this can be achieved. The industry structure is sound. Our people are committed and energized and the operating assets are robust. The application of macroeconomic insight and financial discipline are key, and we will be very focused in our approach. We will deploy CSL's capabilities to generate sufficient profit and cash flow to allow immediate returns to shareholders, along with funds for targeted investments to drive future profit growth. We are making progress and will maintain momentum.

Thank you, Gordon. We'll now move to Q&A. [Operator Instructions]. I will now hand over to the operator.

Thank you. [Operator Instructions]. Your first question today comes from David Bailey with Morgan Stanley.

Sorry, apologies for that. Just would like to understand a little bit some of the implied second half growth rates coming through. So can you maybe talk a little bit about what you think Ig and albumin growth would be on a full year and implied second half basis? And then as we work through the income statement in constant currency, can I just confirm that you're expecting growth for CSL Behring at the gross profit level? There was a comment earlier that you're expecting growth for Behring, just making sure that, that is a gross margin -- a gross profit number, sorry, for the second half.

Thanks, David. It's Ken. So in relation to your first question on Ig, following the updated guidance, we expect Ig to be broadly flat from fiscal '26 compared to fiscal '25. So we do see growth in the second half in Ig compared to previous corresponding period and the trailing period, so probably in the low single-digit range. Albumin was obviously down quite considerably in the first half, about 27% for the full year, probably down in the mid-teens. So what that would suggest for the second half is a little down versus prior corresponding period and up on the trailing period, just recognizing the softness of the first half results. For Behring overall, we are seeing the revenue flat to potentially a little down on fiscal '26 -- sorry, fiscal '26 to fiscal '25. We're seeing growth second half compared to the previous corresponding period and the trailing period. We are expecting to see a degradation in the Behring gross margin. So the revenue updates that we communicated today are products that have on balance, a relatively higher margin. And so our current outlook is that the Behring gross margin may fall by around 1% versus '25. And so that's going to affect the gross profit that we report in fiscal '26.

And just one quick follow-up, if I can. I know there was a lot in there. But just on the Ig number, you mentioned there's some disruptions there around channel. Just can you maybe talk a little bit about the -- what you're seeing in the fourth quarter and exit rate expectations into fiscal '27, please?

I'm going to respond to -- let Diego talk about what we're seeing. I think I heard, David, you talked about fiscal '27, which we're not in a position to comment about '27 at the moment, but over to Diego.

David, this is Diego. So thanks for the question. When we look at the trend of Ig, we continue to see underlying demand that is on the mid- to high single digits. So that's very healthy. And we continue to see half-over-half growth. So we see an acceleration. And as it was kind of part of the remarks, some of that demand acceleration has been muted by the normalization of the channel.

Your next question comes from Dan Hurren with MST Marquee.

Apologies, actually on a plane at the moment, so I can't join the call. Look, obvious question, given the CEO churn, you had an old CEO, an interim CEO, a new CEO about to be appointed, will the Board be in a position to offer investors some continuity in terms of the standing behind these key numbers and impairments so we can avoid the whiplash of another reset?

So it's Gordon here. So I think there's no doubt that the Board is standing behind the changes. And so we've -- it's -- we've had a lot of engagement with the Board between the executive team and the Board, and they're fully supportive of the changes. They -- which we're making to the business and the reporting and the reviews and so on. The -- and then looking forward, the CEO transition is in flight, going according to plan and it's well supported by the Board and obviously by me.

Look, just a housekeeping question. Could we just talk about -- just for the models, the amortization on the -- and add back the other non-trading items at the bottom of the P&L for FY '26?

Sure. I'll discuss the impairments in more detail. So Gordon referenced his review of the business. And as you'd expect, that also included a review of our balance sheet. As we look at the businesses today, I think you've heard an update on the Behring business. We're seeing second half growth versus the relevant previous periods. And I think Gordon has also indicated that the Seqirus business is probably doing a little better than our previous expectations. In Vifor, we are facing some challenges across both the iron and nephrology parts of that portfolio. So iron, we've spoken previously about the rising impact of generic competition. Iron as a franchise in the first half, if you recall, fell by about 15%. As we look forward, we expect to see an increase in that rate of decline. On the nephrology side, that has historically been a source of growth in recent periods. One of the major contributors to that was a product called Velphoro, which benefits from a 2-year TDAPA reimbursement framework in the U.S., which ends at the end of this calendar '26. So Velphoro is a product that has already reached its peak contribution in the first half. And so into the second half of this fiscal year and going forward, we expect to see declines in that product, and that contributes to an overall decline in the broader nephrology portfolio. So these are things that we need to assess. We need to look at those forward-looking expectations versus the carrying value of Vifor. Those assets and carrying values were set back in '22 when the business was first acquired. And as a result, we expected to book some impairments.

But I guess the question is you got to NPATA, what's the add-back? I'm trying to get to underlying here.

I'm sorry, could you repeat that question on the impact on NPATA, is that the question?

So I'm just trying to get a physical number. What is the amort add-back that you're using in your NPATA for the guidance you've given today?

Yes. So the guidance that we gave on NPATA was excluding any restructuring and impairment costs. So that will be incremental to that.

Your next question comes from Davin Thillainathan with Goldman Sachs.

Gordon, perhaps a question for you. Your 90-day review, could you perhaps talk to some of the changes that you've actually put through? We can't really see much that's changed on the slide deck. So perhaps some updates from your perspective. And then if you can tie that into how those changes are helping your Ig market share, please?

So I guess the broad comment would be that I've made a number of changes, but they have been much more around focusing the business than wholesale direction changing, and that reflects the fact that the substantive work has already been in flight. And so the restructuring of the R&D group, reduction of infrastructure in that area and just general focusing of the business has all been in flight for some time and it is going quite well. More narrowly, I'll hand over to Diego perhaps to make some more granular comments about the commercial piece. But just broadly, I think the -- what we've seen over the -- I guess, over that period of the review is that competitors have strengthened their supply chain, so they've been able to be more reliable. In addition to that, they have developed products which have challenged our, I guess, our lead position as an innovator in the space, which has made the competitive pressures that the organization had faced in key markets more difficult. And the organization, I think, has been slow to respond to that. And so now what we're seeing is this sort of pretty major retooling. We have to -- obviously, we will increase our investment in that space, but we've also added capability to better understand those markets and to, I guess, more aggressively support the sale of our products, especially in the U.S. I'm not sure whether you want to add anything further to that, Diego.

So thank you, Gordon. I would just kind of -- we talk about the increase in our customer-facing our sales organization in the U.S. We talk about our focus on direct-to-patient communications that we have enhanced beyond the brand into diagnosis that is a clear lever of growth. And also, I will call out the recent enhancements that we've done around analytics that is giving us a very deep understanding on how to focus our efforts in front of our customers. And actually, we have a pretty long pipeline of improvements that are planned for 2027. We see this continuous flow of improvement that we need to continue driving the demand across the different regions.

Maybe just a follow-up, Gordon, as well, given your experience with the company. Your comments about competitors getting better with their supply chain, do you sort of feel CSL's cost per liter on the Ig front, do you feel like you're still the lowest cost provider here?

Yes is the short answer. And I think it's reflected in the gross margin structure for Behring, which continues to be pretty robust. Obviously, not as good as we'd like. And so I do see opportunities to consolidate and strengthen that advantage. But yes, the short version would be that -- I think we're starting from a pretty good location.

Your next question comes from David Low with UBS.

If we could just start with pricing environment. I was just trying to understand from your commentary about inventory in the channel and competitors, how much of a price degradation have we seen in key products in, I guess, U.S. and China?

This is Diego. Thank you for the question. So when we look at the U.S., the adjustment that we're making is related with our increased oversight of the channel beyond the specialty distributors has nothing to do with price. When -- as you know, we have different price points for different channels in the U.S. But when you look at our ASP, our average selling price has been stable in a very tight range, and we see that moving forward. When we look at China, following the disruption that happened last year in the market, we did see a price decline. We've referred to it at around 10% price decline. We do see a continuous price erosion in China but a much lower rate. So we see a stabilization of the price. And at the same time, we see a slight growth of the volume. So we do see signs in China of market coming back to a more stable trend. Obviously, we remain vigilant and ready to react to market conditions.

And my follow-up, just on the gross margin. So you talked about 100 basis points, Ken, of headwind. Can we walk through the three factors that have been outlined, so Ig, albumin and other -- and which of those impacted gross margins? And of course, what we're really trying to understand is the exit gross margin for this year, what are the implications going into next year? I know you don't want to talk about '27, but just understanding the trends there. Is there likely to be a recovery or likely further decline would be helpful, please?

Sure. So I'll ask -- answer the second question first. Our objectives and our strategy continues to be to expand the Behring gross margin. That's obviously not what we're expecting in fiscal '26 because of the headwinds that we have described, the fact that as a result, we're seeing a flat outcome on the Behring revenue line with some degradation in some of the relatively more high-margin products. But going forward, margin expansion is still very much part of our outlook. In relation to the components that we've discussed today, give you a little bit more detail. So the $300 million Ig headwind is in the U.S., and it's principally HIZENTRA. So that has a margin, which is obviously higher than PRIVIGEN and obviously higher than what you see in other parts of the world. So that's a significant contributor to that margin impact. Secondly, for China albumin, given the pricing that we see in China, it's on the higher end, certainly the highest margin that we have for albumin. So that has an impact as well. And then that final group contains within it, if you recall, HEMGENIX and iron, and they're both high-margin products as well. So back to my earlier point, the drivers that we're seeing with this updated guidance are all relatively high-margin products.

Just on HIZENTRA. So just trying to understand with these inventory adjustments in the channel, is that one-off in nature or effectively that headwind continues into next year?

It is one-time in nature. As I mentioned before, we have developed a much deeper understanding, and we have taken the needed actions to reach the average inventory that supports our underlying demand that continues to grow at mid- to high single digits. Again, this is behind us. I think it was an important step, and now we're very focused on the excellent execution moving forward.

Your next question comes from Lyanne Harrison with Bank of America.

Can I just go back to Ig again? You mentioned that the market for Ig was balanced in terms of supply and demand. What gives you confidence that, that's the case? We look at one of your peers, they reported their first quarter last week. They've got 15% growth in Ig. You're talking about second growth -- second half growth in Ig being low single digits. I hear what you're saying about inventory, but our channel checks still suggest that there's a bit of inventory in the market. What sort of -- how many months of normalized purchasing patterns have you seen recently? Can you call out what you saw in third quarter fiscal '26 in terms of Ig growth?

Sure. So when we look at the underlying demand inventory, I think it's pretty consistent across the board. We see numbers normalize over time. So I don't have any concerns when it comes to that underlying growth. When it comes to inventory, look, I cannot comment for our competitors. What I can kind of share with you is that we've completely changed the way that we look at the inventory, particularly in the U.S. We have a much more holistic picture. And we are not considering something that we have not in the past, which is the impact of the 340B contracted pharmacies. This is a dynamic that is not new to the U.S., but it's been growing in the case of Ig. We look across the different layers, and we've been adjusted our inventory for about four weeks. And we're now tracking very closely to an average of six weeks of inventory at the different levels of channel moving forward. So again, a very deep understanding. We have now a much granular planning, and we are at the level that we think is healthy, and we plan to keep it at this level moving forward.

If I might just build on that, Lyanne, you asked some questions to try and understand the growth rates. And so just to remind you that fiscal '25 had quite an unusual skew in Ig between first half, second half. And so as I said earlier, while fiscal '26 compared to all of fiscal '25, we expect Ig to be broadly flat for the second half of fiscal '26, that explains why we expect to show growth versus both the PCP and the trailing period.

And can I follow up with just a question on China albumin. Obviously, you're doing a lot of work there. You've got 100 new hospitals that you're selling into. Can you talk a little bit about the distribution arrangements that you have in place? And in terms of that growth in market share for the last three months of 0.5%, it feels like it's a lot of effort to get that little bit of share growth. What are your thoughts into fourth quarter? And then what's the expectation for the market? I know you're not talking about or giving guidance to '27, but what's your expectation for the market for the next, I guess, 12 months?

Sure. So let me talk about the arrangements that we have. The way that we're approaching China is a well-proven commercial strategy in China, has been done multiple times. We look at the channel and geographical expansion. The geographical expansion in the hospital channel, we're doing it with our own resources and in the retail, which is a much kind of broader set of customers, we're doing it with the partnership of Baheal. With Baheal, we have a set of contracted volumes that we are working with them, and we have a very close partnership. I understand the share gain seems small. It's been a relatively short period, and these things take time. But again, I think this is a well-proven strategy in China, and we are confident that we will continue to yield results, and we're looking at an increased pace. Look, the underlying dynamics that we see in China, as I mentioned before, is return to grow on volume and continuous pressure on price at a much lower rate that we've seen until now. So pretty stable growth from a volume perspective moving forward.

Your next question comes from Saul Hadassin with Barrenjoey.

Just a couple of questions. First one, there was some commentary at the half year about operating costs, particularly general and admin and I think R&D. Any update you can give maybe, Ken, on whether you're still thinking those costs will be similar to what you guided to, in other words, flat G&A. And I think you gave some commentary on R&D as well at the half year.

Sure. So outside of the specific updates that we're giving today, there's no change in the guidance for those other elements that you mentioned. So to reiterate what we said at the first half that for both G&A and R&D, we expect the full year to be roughly 2x the first half. The cost-out programs remains on track. No change in our full year expectations for that.

And can you also previously advised that as we move into FY '27, there's going to be a shift to NPAT from NPATA. Is that still the thought as we move into the next fiscal year?

So the move to NPAT versus NPATA, that's right, from '27 onwards. There will also be some changes. Gordon mentioned operational separation of Seqirus. So there will also be some changes in our segment notes. So we'll be able to disclose the earnings of the Behring and Vifor segment on the one hand and the Seqirus segment on the other hand, down to EBIT.

Your next question comes from David Stanton with Jefferies.

I wonder if I could talk to -- continue to beat the dead horse of Ig in the U.S. and talk to why there's been increased inventory in the hospital channel. What are your hospital channel partners collecting more plasma for or more Ig for, please?

So just to clarify, the increased inventory in the U.S. is not specific to the hospital channel. It's in our distribution partners that have two layers. The first one is the specialty distributors that we've been monitoring for a long time. And the second one is the specialty pharmacies that is kind of one level removed from us. So in the last few months, what we've done is a very deep analysis of -- at the account level of these channels. And we have observed that over time, inventory has been creeping, particularly in the second layer of the specialty pharmacy and driven by this 340B dynamics. So now that we have the insights now that we understand in a much deeper level. We think this is the right move to course correct this and to move forward in our new channel strategy with a healthy level of inventory. So this is not something that is kind of ups and downs. It's gradually creeping in. And given our insights today, we're in a better place to manage it now and leaving it behind and moving forward on an ongoing basis.

So just a follow-up then. I sort of understand why 340B is requiring more volume. Perhaps you could give me some color around that.

This is one of my favorite topics, 340B. So it's not -- so what is happening is that 340B contracted pharmacies. So these basically are 340B hospitals that they contract with the specialty pharmacies to deliver 340B volume, okay? The way that this works is that this is not fully transparent to us. This is not reported to us, the volume that is going through that. And so we have developed the capability through combining multiple sources to now identify the volume that is going through that channel, and that has uncovered this growing volume over time in this channel. Again, this is not new to the U.S., has happened in other categories in the past. And what we've seen is lately in the Ig category, more volume flowing through the contracted pharmacy of 340B. So more visibility, greater insights and helps us to manage the inventory appropriately given this dynamic.

And perhaps I could ask my second question then, specifically around the Baheal contract. And I was just wondering if that's -- because I hear different things in the market, whether that's a take-or-pay contract or whether it isn't. And if it is, have we seen them take what they said they were going to take, please?

So yes, we have committed volumes with Baheal, and the contract is being executed as planned. And we also have a very close partnership with them, making sure that we have the right level of oversight of the execution of that contract.

Your next question comes from Laura Sutcliffe with Citi.

Could we visit the topic of infrastructure overbuild? Could you outline what some of the assumptions were that led to that and how those historical assumptions are linked to today's demand profile for the products it might involve?

Sure. So Gordon's earlier comments about infrastructure build apply to several aspects of the business. And some of these decisions and investments actually go back several years. So they include, for example, investments in Lengnau facility in Switzerland, which commenced in 2014. A little bit after that, we made significant infrastructure investments in R&D facilities around the world, most notably in Germany, in Marburg. We have also expanded capacity across other parts of the business as well, including cell culture and overall manufacturing capacity. So it reflects manufacturing capacity as well as infrastructure that supports other parts of the business, particularly R&D. As we look at the utilization of that infrastructure today, some of it is underutilized, and we need to work through the implications of that for carrying value.

And then maybe a second question at a higher level. I know you don't have a crystal ball, but are you confident that the review that you've undertaken has gone into all of the corners of the business thoroughly? Or is there anything else that you feel like we should continue to watch out for?

Thanks, Laura. We expect it has. That was the idea behind giving, I guess, a headline figure, which is still an estimate, but is intended to address, for example, whether these things are recognized in the current financial year or the next one.

Your next question comes from Steven Wheen with Jarden.

Just wanted to go back to the previous commentary that you made at the interim around cost out. It was a figure of $500 million to $550 million. Has that changed or perhaps more helpful would be that you did issue that guidance with some caveat over what amount the P&L might get to retain versus reinvesting? Can you give us any more color around that because that obviously is fairly meaningful with regards to trying to produce a P&L for this business?

Sure. So just to reiterate some of the comments that I made earlier and then give you some further guidance. So what I've said earlier is that when you look forward, particularly as far as fiscal '28, and we think about the $500 million to $550 million of cost savings and what we do with it, we are being very rigorous across our capital allocation priorities. There was a slide from Gordon where he outlined three major priorities. So reinvesting in growth, maintaining balance sheet gearing within a specified band with the expectation that after attributing the right amount of capital to those two, we'll still generate excess cash, and that will be returned to shareholders. Now particularly when you're going out to as far as '28, what those reinvestment decisions might be is a forward-looking statement that will depend upon what we see at the time, and this largely relates to the R&D portfolio. So we've made a lot of changes in the R&D function. We've taken a lot of fixed costs out. You'll see that in the R&D expense line, which for fiscal '26 will be less than fiscal '25. And so for fiscal '26, the majority of those cost savings are being effectively released into the P&L. But we do need to reinvest in growth. And so my expectation is that the R&D line will increase over time as we add more substrate into the clinic. And that will, therefore, use up a portion, but certainly not all of the cost savings that we're intending to take out of the business. So I would say near-term expectations that the majority of those cost savings will be released to the P&L in the -- more in the medium term. It will depend upon what we do, particularly in R&D, and that includes what we might do in business development. We've been very vocal about the fact that part of our strategy for strengthening the R&D pipeline is through partnerships. So transactions such as what we did with VarmX, where once we do those deals, we also bring on incremental R&D expense. And so there's obviously a level of uncertainty with our ability to strike those deals, which is why you're not getting a completely precise ratio for me right now about how much of the $550 million will be reinvested versus release to the P&L.

And second question is a bit of an accounting question. Just curious about the $5 billion impairment that is in addition, I think, to the $1.5 billion from first half, just to confirm that. But secondly, from an impairment perspective, I don't really understand why it's a multistage impairment across two years. Like isn't an impairment just as you see it at this point in time? Could you just clarify that a little bit further? And it would be -- I know you've said that guidance -- all other measures of guidance have been retained, but just would be nice to hear that you still expect to do high single-digit growth in '27 and '28...

Sure. So yes, your first question, the $5 billion is incremental to the $1.5 billion pretax pre-NCI number that we announced at the first half. In relation to the timing of those impairments, so we need to do further analysis. We need to have much more in-depth conversations with our auditors. And in some cases, the drivers of those impairments may not be fully clear or understood at the time we close our accounts in June of 2026. So for example, the incoming generic competition for iron in the U.S. won't have happened at that point in time. And so assessing what that impact is obviously a judgment call where we're looking to get some more data points. And to give you an example, in Europe, the initial price impact was less than what we initially thought. But we have seen generic competition in Venofer in the U.S. where the price competition was fairly aggressive. And we still to see what the price competition will be for Injectafer, which is the much larger product in the U.S. So from an impairment perspective, you need to have those key assumptions locked down so that you can get the requisite audit sign-offs. And we're just flagging the likelihood that not all of those developments or assumptions may be completely transparent at the time we close the books. In relation to fiscal '27, on this call, we're focusing on the update for fiscal '26. At this time of the year, as always, we are running through a detailed ground-up budget process that will inform our fiscal '27 expectations. And as we do in the ordinary course, we'd look to provide the market with an update on that at the full year results in August.

Your next question comes from Sacha Krien with Evans & Partners.

A couple more on Ig. Just can your comments suggest that it's sort of a CSL-specific inventory issue, and that's now cleared, which -- does that mean we should be thinking about growing in line with end market demand going forward? So if you could comment on that. And then just a related question, I don't think I fully understand why clearing your own inventory backlog is the only issue. We've had pretty consistent feedback that there is excess inventory in the broader U.S. market, including in SCIg. So I'm just wondering if you think that also needs to clear before we can get back to sort of more like end market demand growth?

So again, when we look at our inventory situation has been now cleared, and we see the market and we see our demand growing on the mid- to high single digits and is also triangulated with market data. As Gordon shared, we have early signs of market stabilization for HIZENTRA and increase for PRIVIGEN. So yes, the idea is to grow with the market in the U.S. Ig.

And then second question, just on HIZENTRA market share. So it was still 55% according to the presentation. I'm just wondering if you think that is sustainable over the medium to long term, given that's now a far more competitive space.

So in the current market situation with HIZENTRA, we're not only focusing on market share, but we are also focusing on expanding the market. As we mentioned before, we've done significant efforts around direct to patient that is looking into the brand choice and -- but also into diagnosis, particularly in PID. So we do have a set of commercial improvements planned for the second half of the calendar year that should help us to retain this market share. Obviously, when you are the market leader with a 55% and a lot of competitive -- competitors in the market, that's a situation that takes a lot of effort to sustain, and we are encouraged by the progress we've made and the data is showing us an encouraged trend. But again, we don't -- we're not resting on our laurels. We know that there's a lot of work ahead, and we have a steady pipeline of commercial improvements to help us sustaining it.

Your next question comes from Andrew Paine with CLSA.

Just coming back to China albumin, just be good to get a little bit more info here around what you're seeing in terms of pressures over and above? What you're expecting at the first half results. Obviously, the hospital channel is somewhat understood, but are you seeing any pressures in the retail market, particularly around pricing?

So kind of our forecast for the year for China was an increase in volume that we are seeing, but not at the levels that we were anticipating and a plateauing of the price erosion. What we see is we do see the volume increase, again, at a lower rate. We do see our market share improvement driven by our commercial efforts, again, at a lower rate than we were hoping for. And we see a price that is continue to erode at a much lower rate than we saw originally. So our focus now is to continue driving the market share and continue to be responsible in terms of how we price. And we see an opportunity to grow both in the hospital and in the retail channels with our partnership with Baheal. So we remain very vigilant. So China is a market that has been disrupted and it's a market that changed quickly. We've seen it in the past in this category and in others, but we're ready to react as appropriate.

Just on that contract with Baheal, is -- that's volume and price that's been agreed, hasn't it?

So there is a range for both. So yes, we are expecting a stable output of that contract, and we are in very close collaborations with Baheal, making sure that we are not -- that we're very attuned to the market dynamics.

And you're like in line with the expectations for that? Or are you implying here that it's a slower start than expected?

It's aligned with expectation. Again, it's relatively soon in the partnership. So we need to keep seeing how things evolve. But we don't have a concern at this point in time, just kind of keep working and keep driving the demand that is needed. But again, it's early in the partnership yet to have a definitive assessment.

And just -- I'm not sure if you mentioned this before, but the revised HEMGENIX growth. Can you just provide some views around what you had previously and where you are now?

Sure, I'll take that one. So HEMGENIX is still growing. We expect to see good growth for the full year growth in the second half versus both PCP and trailing. So that's ongoing momentum that we called out earlier in the presentation.

And one last one, if possible. Just can you split out the Middle East conflict impact? It's part of the $150 million, but good to know what that is specifically.

Sorry, can you say that again?

Sorry, you're calling out the Middle East conflict as part of the $150 million revenue. What's that specifically?

So this is shipments into Iran. So we've had to pause those shipments. So there's a loss of revenue as a result. Outside of Iran, we're still shipping.

So are you able to give a dollar figure for that as part of the $150 million?

Across the three parts of that last driver that we called out. So we said there was $150 million across the Middle East and HEMGENIX and iron, roughly 1/3 that you can attribute to each of those.

Your next question comes from Elizabeth Davies with Bank of America. Elizabeth Davies, your line is live, please proceed with your question. We'll just move on to the next question. This is from David Low with UBS.

Thanks for the follow-up question. Gordon, maybe one for you. I mean one of the things that's changed in the market most recently is this Egyptian plasma arrangement with European approval of products based on it. And my understanding is the price or the cost differential there is pretty substantial. Just wondering what you think of that strategy? And is that something that CSL will consider in the medium term?

Yes, we can't really comment, Dave, on other players. I think from our perspective, we're very focused upon making sure that we collect high-quality, safe plasma at the lowest possible cost. It's sort of the -- it's usually the beginning of my conversations with Steve Marlow, and then we exchange greetings.

Your next question comes from Stuart Welch with Alphinity.

Just a few quick questions for each of you. So Ken, is it fair to say -- previously, you guys have had medium-term guidance out there in the market for high single-digit NPATA growth. Is it fair to say that, that is off the table at this point? And then, Gordon, one for you. You talked about Horizon 2 and then measured investment into Horizon 2. If you could talk to that. And Diego, sorry, just one for you, so nobody has left out. You talked about growing in line with market in the U.S. So is that right you're happy to grow at system growth in the U.S. and not grow market share? Is that -- have I interpreted that correctly?

I'll take the first one. So we'll provide an update on '27 when we get to August.

On the measured investment piece, that's -- we're just -- we're just having to be thoughtful -- we're just being thoughtful that we make our investment decisions, particularly in hard capital as we reach various regulatory and technical milestones.

On the U.S. market growth, so as I mentioned, we want to -- I mean, our plan and we see the dynamics to grow around the market growth. That could be hopefully a little bit higher, but that's kind of the goal. The reality is that this is a market that tends to equilibrium, and we are a big player in this market. So yes, we are planning to grow around the market rate. And again, there is a range on the mid- to high single digits that we will need to show as we move forward, and we are focusing on execution now.

There are no further questions at this time. I'll now hand back to Ms. Michelle Rees for closing remarks.

Thank you. With no more questions in the queue, I'll draw the briefing to a close. Thank you for your interest in CSL.